US20050197692A1 - Systems for heart treatment - Google Patents
Systems for heart treatment Download PDFInfo
- Publication number
- US20050197692A1 US20050197692A1 US11/120,470 US12047005A US2005197692A1 US 20050197692 A1 US20050197692 A1 US 20050197692A1 US 12047005 A US12047005 A US 12047005A US 2005197692 A1 US2005197692 A1 US 2005197692A1
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- anchor
- tensioning
- heart
- tensioning structure
- structures
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Definitions
- the present invention relates generally to minimally invasive medical devices for treating or preventing congestive heart failure and related or concomitant valvular dysfunction. More specifically, the invention relates to tensioning structures and related deployment devices to mitigate changes in the ventricular structure and geometry and deterioration of global left and right ventricular performance related to tissue damage from myocardial ischemia, acute myocardial infarction (AMI), valve related disease or dysfunction, or other instigators of deterioration of cardiac function.
- AMI acute myocardial infarction
- valve related disease or dysfunction or other instigators of deterioration of cardiac function.
- CHF Congestive heart failure
- non-cardiac factors can also be activated due the overall degenerative cycle that ensues. These include neuro-hormonal stimulation, endothelial dysfunction, vasoconstriction, and renal sodium retention-all of which can cause dyspnea, fatigue and edema rendering patients unable to perform the simplest everyday tasks. These types of non-cardiac factors are secondary to the negative, functional adaptations of the ventricles, cardiac valves and/or load conditions applied to or resisted by these structures. With existing pharmacological, surgical and device-based therapies symptoms can be alleviated, but the quality of a patient's life remains significantly impaired. Further morbidity and mortality associated with the disease is exceptionally high.
- Ischemic heart disease is currently the leading cause of CHF in the western world, accounting for greater than 70% of cases worldwide.
- CHF can precipitate from ischemic conditions or from muscle damage (i.e., due to obstruction of a coronary artery) which can weaken the heart muscle, thereby initiating a process known as remodeling in which changes in cardiac anatomy and physiology include ventricular dilatation, regional wall motion abnormalities, decreases in the left ventricular ejection fraction and impairment of other critical parameters of ventricular function.
- Such left ventricular dysfunction may be further aggravated by hypertension and valvular disease in which a chronic volume or pressure overload can alter the structure and function of the ventricle. Decreases in systolic contraction can lead to cardiomyopathy, which further exacerbates the localized, ischemia damaged tissue or AMI insult into a global impairment, thereby leading to episodes of arrhythmia, progressive pump failure and death.
- Ischemia-damaged and/or infarct damaged heart muscle tissue results in progressive softening or degeneration of cardiac tissue.
- These ischemic and infarcted zones of the heart muscle wall have limited, if not complete loss of tissue contractile functionality and overall physical integrity and present an analogous situation to those presented by vascular aneurysms.
- CHF is usually associated with a progressive enlargement of the heart as it increases contractility and heart rate in a compensatory response to the decreasing cardiac output.
- a phenomenon known as myocardial stretch is implicated in a degenerative cycle/ feedback loop that causes areas of compromised heart muscle tissue to bulge further outward.
- this behavior is characterized as infarct expansion.
- the heart's natural contraction mechanism is dissipated and attenuated, resulting in a marked and progressing decrease in cardiac output.
- Normal cardiac valve closure (especially that of the mitral valve) is dependent upon the integrity of the myocardium, as well as that of the valve apparatus itself.
- the normal mitral valve is a complex structure consisting of leaflets, an annulus, chordae tendineae, and papillary muscles. Any damage or impairment in function of any of these key components can render the valve structure incompetent. Impairment of valve function, due to independent factors (i.e., a concomitant valve pathology) or dependent factors (i.e.,valve dilation related to dilated cardiomyopathy), can result in valvular insufficiency further exacerbating the degenerative CHF cycle.
- the major objectives of heart failure therapy are to decrease symptoms and prolong life.
- the American Heart Association guidelines suggest that optimal treatment objectives include means to increase survival and exercise capacity, and to improve quality of life, while decreasing symptoms, morbidity and the continued progression of the cardiac degeneration.
- Various pharmacological and surgical methods have been applied both with palliative and therapeutic outcome goals. However, there still remains no definitive cure for CHF.
- Furosemide (more commonly known as LasixTM) is also a valuable diuretic drug which eliminates excess water and salt from the body by altering kidney function and thereby increasing urine output, thus relieving circulatory congestion and the accompanying pulmonary and peripheral edema.
- Vasodilators like angiotensin-converting-enzyme (ACE) inhibitors have become cornerstones in treatment of heart failure. These kinds of vasodilators relax both arterial and venous smooth muscle, thereby reducing the resistance to left ventricular ejection. In patients with enlarged ventricles, the drug increases stroke volume with a reduction in ventricular filling pressure. Administering digoxin has also been found to be positively inotropic (i.e., strengthening to the heart's contractile capability).
- ACE angiotensin-converting-enzyme
- cardiomyoplasty is a recently developed treatment of CHF.
- the latissimus dorsi muscle is removed from the patient's shoulder, wrapped around the heart and chronically paced in synchrony with ventricular systole in an effort to assist the heart to pump during systole.
- the procedure is known to provide some symptomatic improvement, but is controversial with regard to its ability to enable active improvement of cardiac performance. It is hypothesized that the symptomatic improvement is primarily generated by passive constraint and mitigation of the degenerative, remodeling process. In spite of the positive outcome on relieving some of the symptoms, the procedure is highly invasive, requiring access to the heart via a sternotomy, expensive, complex and of unknown durability (due to the muscle wrap blood flow requirements and fibrosis issues).
- Surgical treatment of valvular dysfunction includes a wide range of open procedure options ranging from mitral ring annuloplasty to complete valve replacement using mechanical or tissue-based valve prosthesis. While being generally successful and routine in surgical practice today, these procedures are also costly, highly invasive and are still have significant associated morbidity and mortality.
- LVAD left ventricular assist device
- TAH total artificial heart
- Other device-based options for CHF patients include approaches for reshaping, reinforcement and/or reduction of the heart's anatomical structure using polymeric and metallic bands, cuffs, jackets, balloon/balloon-like structures or socks to provide external stress relief to the heart and to reduce the propensity/capability of the cardiac tissue to distend or become continually stretched and progressively damaged with pump cycles. Examples of such devices are United States Patent No. 2002/0045799 and U.S. Pat. No. 5,702,343. In addition, devices are being studied that attempt to prevent the tissue remodeling using tethers and growth limiting struts or structures described in various patents (i.e., U.S. Pat. No. 6,406,420).
- transplants represent a massive challenge with donor hearts generally in short supply and with the transplant surgery itself presenting a high risk, traumatic and costly procedure. In spite of this, transplants present a valuable, albeit limited, upside, increasing life expectancy of end stage congestive heart failure patient from less than one year up to a potential five years.
- implant embodiments of the present invention can also facilitate positive or reverse remodeling (i.e., provide a mild compressive force both during systole and diastole to improve cardiac output and efficiency).
- the present invention meets these needs with tensioning structures that can be utilized locally (e.g., left ventricular anterior wall only versus about the entire heart) to reduce wall stresses, reinforce the walls, and reduce/limit volume of the heart muscle as required using percutaneous, minimally invasive surgical (MIS), and open surgical means or a combination thereof.
- Devices according to the present invention may be used to facilitate operator controlled “tailoring” of localized treatment using various embodiments of the invention at various chosen target zones (i.e., left ventricle, mitral valve annulus, or sub-valvular apparati).
- Custom tailoring of each tensioning structure enables application of compression against specific regions of tissue in one, two or three dimensions relative to the heart's surface and patient specific adjustability of the amount of compression applied to the tissue to optimize the heart's overall hemodynamic performance.
- Tensioning structures according to the invention can be individually placed within or about the heart (intravascularly or extravascularly) working in concert to provide reinforcement against myocardial stretch (or infarct expansion) and additionally to facilitate contraction of tissue previously subject to such myocardial degeneration. In doing so, the contractile and expansion energies of the heart can be transferred to and across the weakened sections of the heart from the more viable sections of the heart muscle.
- Such devices provide localized dynamic support or reinforcement and are active throughout the cardiac cycle unlike previous device approaches that generally only reduce the stress in the heart wall during diastole. Diastolic compliance can also be regulated or controlled with structures according to the invention.
- the tensioning structures facilitate and maintain a more efficient and perhaps optimal wall motion through the cardiac cycle thereby aiding in diastolic filling and systolic contraction at the tissue area that has been compromised by ischemia, infarct or other abnormalities.
- the tensioning structures are implanted in target heart regions using standard cardiovascular, interventional techniques using guiding catheters and introducing sheaths or less invasive surgical techniques involving port access or small incisions into the thoracic cavity to eliminate the need for more radical surgery (e.g., median sternotomy) to provide a potential, palliative or therapeutic response to the disease.
- the tensioning structures of the invention may provide a complete, comprehensive solution for treatment of congestive heart failure addressing deficiencies to the wall motion of the heart (e.g., akinesis, hypokinesis or dyskinesis), and/or valve insufficiencies.
- the present invention comprises such device-based technology as summarized above, that is further described below with associated methodology, including deployment, production, development and use of the same.
- the invention shown herein may be provided or used in connection with the invention described in U.S. Provisional Patent Application Atty. Docket No. EXMA-002PRV, entitled “Minimally Invasive Cardiac Force Transfer Structures,” to the inventors hereof and filed on even date herewith, the same being incorporated by reference in its entirely as part of the present invention.
- FIGS. 1A and 1B show perspective views of a healthy heart in systole and diastole, respectively.
- FIGS. 2A and 2B show perspective views of a diseased (enlarged) heart in systole and diastole, respectively.
- FIGS. 3A and 3B show perspective views of a diseased heart reinforced with an intravascular, tensioning structure of the invention in systole and diastole respectively.
- FIGS. 4A and 4B show perspective views dramatizing the progression of myocardial stretch (or infarct expansion) in a diseased, enlarged heart with the infarcted/ischemic zone shown as highlighted;
- FIG. 4C shows a perspective view of the heart of FIG. 4B reinforced with an intravascular, tensioning structure of the invention.
- FIGS. 5A and 5B show anterior views of a heart with intravascular, tensioning structures of the invention being percutaneously deployed into various target vessels.
- FIGS. 6A and 6B show posterior views of a heart with intravascular, tensioning structures of the invention being percutaneously deployed into various target vessels.
- FIGS. 7A and 7B show exploded cut-away views of vessels in which a tensioning structure is placed, with each of the structures anchored transmyocardially.
- FIGS. 8A to 8 F show various tensioning structures of the invention.
- FIGS. 9A and 9B show side views of various tensioning structures adapted for anchoring in branch vessels.
- FIGS. 10A to 10 C show side views of various tensioning structures that incorporate tensioning springs.
- FIG. 11 shows a side view of a tensioning structure embodiment incorporating independent wire components interlaced with one another.
- FIG. 12 shows a side view of a tensioning structure embodiment incorporating a tubular body with radial anchor members.
- FIGS. 13A and 13C show side views of a ratcheting mechanism of an adjustable tensioning structure.
- FIGS. 14A to 14 D show side-sectional views highlighting the process of positioning a tensioning structure in a delivery catheter.
- FIGS. 15A to 15 D, 16 A, 16 B, 17 A to 17 E, 18 A to 18 D show side views of various tensioning structure anchor members in compressed and expanded orientations, variously.
- FIG. 19 shows a perspective view of a heart with sectional view of the coronary sinus and right atrium.
- FIG. 20 shows a perspective view of a heart with sectional view of the right atrium and right ventricle.
- FIG. 21 shows a perspective-sectional view of a heart incorporating an intravascular, tensioning structure secured by anchor members at the coronary sinus and the right ventricular outflow tract.
- FIG. 22A shows a perspective-sectional view of a heart incorporating an intravascular, tensioning structure secured inside the coronary sinus and at the ostium of the coronary sinus in the right atrium;
- FIGS. 22B to 22 F show perspective views of a heart dramatizing highlighting the process of inserting and anchoring the distal end of a tensioning structure into the coronary sinus and anchoring the proximal end along the epicardial surface of the heart.
- FIG. 23 shows a side-sectional view of an intravascular, tensioning structure secured within a vessel in which another vessel is located below or underneath the target/treated vessel.
- FIG. 24 shows a perspective view of a heart with sectional view of the right ventricle and right atrium showing an intravascular, tensioning structure deployed in the coronary sinus and secured on one end to the right ventricular outflow tract.
- FIG. 25 shows a perspective view of a heart with sectional views of the coronary sinus and right atrium broken showing an intravascular, tensioning structure deployed in the coronary sinus and anchored on one end to the ostium of the coronary sinus in the right atrium.
- FIGS. 26A to 26 D show side-sectional views of intravascularly deployed tensioning structures indicating various attachment points between tensile member and anchor components of the tensioning structure.
- FIGS. 27A to 27 C show close-up views of various anchor structures in connection with various tensile member attachment points.
- FIGS. 28A to 28 M show side views of various anchor structures and attached tensile member configurations for tensioning structures according to the invention.
- FIG. 29 shows a side-sectional view of a ratcheting mechanism of an adjustable tensioning structure.
- FIG. 30 shows a cross-sectional view of the distal tip of a delivery catheter system used to place tensioning structures.
- FIGS. 31A to 31 C show side-sectional views of a vessel dramatizing the process of intravascularly deploying a tensioning structure comprising a deformable anchor using a balloon expandable, delivery system.
- FIGS. 32A to 32 C show side-sectional views of an ostium to a vessel highlighting the process of deploying a self-expanding anchor member of a tensioning structure using a retractable sheath delivery system.
- FIGS. 33A and 33B show cross-sectional views of tensile members in a vessel illustrating variance in force distributions.
- FIGS. 34A and 34B respectively, show a perspective view and a close-up view along line B-B of a tensioning structure anchor with a locking mechanism adapted for manually tightening the tensile member.
- FIGS. 34C to 34 E show side views highlighting fabrication steps of the locking mechanism used in FIGS. 34A and 34B .
- FIGS. 35A to 35 D show a side, perspective, and two-sided sectional views, respectively, of another anchor structure adapted for manual adjustment and locking of the tensile member.
- FIGS. 36A to 36 D show top and perspective views, respectively, of a deployment system used to insert tensioning structures into or through myocardium.
- FIGS. 36E to 36 H show perspective and side views, respectively, of two tensioning structures deployed into or through myocardium with delivery systems such as that shown in FIGS. 36A to 36 D.
- FIGS. 37A to 37 C show cross-sectional views of the heart broken in sections with the deployment system of FIGS. 36A to 36 D inserting the tensioning structures of FIGS. 36E to 36 H into/through the myocardium.
- 38 A to 38 C show cross-sectional views of the heart broken in sections with an alternative deployment system used to insert the tensioning structures of FIGS. 36E to 36 H into/through the myocardium.
- FIG. 39A shows a cross-sectional view of the heart broken in sections with the tensioning structures of FIGS. 36E to 36 H deployed and secured into/through the myocardium in the right ventricle and the left ventricle;
- FIG. 39B shows a cross-sectional view of the heart with the tensioning structures embodiments of FIGS. 36E to 36 H deployed and secured along the valve annulus.
- FIGS. 40A to 40 F show perspective views of a heart indicating various placement configurations of the tensioning structures of FIGS. 36E to 36 H.
- FIGS. 41A to 41 D show a cross-sectional view of the heart, a perspective view and two top views, respectively, illustrating alternative tensioning structure approaches;
- FIG. 41E shows a side-sectional view taken along A-A of the anchor of the tensioning structure embodiment in FIG. 41D ;
- FIGS. 41F and 41G show a myocardial tensioning structure with an anchor that is adapted for manual adjustment and locking of the tensile member;
- FIG. 41H show a close-up view of the anchor formations shown in FIGS. 41F and 41G ;
- FIG. 41I shows a close-up, cross-sectional view of a proximal anchor from a cardiac valve annulus tensioning structure adapted for manual adjustment and locking of the tensile member.
- FIG. 42 shows an alternative, puncturing device used to deploy a tensioning structure.
- FIGS. 43A to 43 D show two side-sectional views and two side views, respectively, illustrating the components of an alternative coaxially arranged delivery system used to deploy tensioning structures.
- FIGS. 44A to 44 C show cross-sectional views of the heart broken in sections dramatizing an extravascular deployment and securing process for a tensioning structure that incorporates anchors at each end.
- FIGS. 45A to 45 B show cross-sectional views of the heart dramatizing a catheter-based delivery and securing process for a tensioning structure that incorporates anchors at each end;
- FIGS. 45C to 45 E show side views with components of the delivery system and process used to deploy and secure the anchor of the tensioning structure in FIGS. 44A to 44 C and 45 A and 45 B within the myocardium or to a tissue surface;
- FIG. 45F to 45 H show perspective views of an anchor member for a tensioning structure highlighting the expansion (e.g., plastic deformation via balloon expansion or self-expansion upon release from an external compression force) for the variation of the invention in FIGS. 45C to 45 E;
- FIGS. 45I to 45 L show three perspective views and one side view, respectively, of an alternative anchor member indicating the fabrication process for a tensioning structure.
- FIGS. 46A to 46 K show side-sectional views of an integrated tensioning structure that functions as a puncturing device for a deployment system, an anchor member, and the tensile member;
- FIGS. 46L to 46 M show a perspective view of the heart with a deployed and secured integrated tensioning structure shown as in FIGS. 46A to 46 K;
- FIGS. 46N to 46 P show a side view and two perspective views, respectively, of alternative delivery systems used to deploy integrated tensioning structures into or/through the myocardium;
- FIGS. 46Q and 46R show perspective views of additional integrated tensioning structures according to the present invention;
- FIGS. 46S to 46 T show a perspective view and a side view, respectively, of another integrated tensioning structure;
- FIGS. 46U to 46 Y show a perspective view, a side view, and side and top close-up views, respectively, of the integrated tensioning structure of FIGS. 46N to 46 O with a separate anchor attached.
- FIGS. 47A to 47 D show a cross-sectional view of the heart dramatizing the process of deploying and securing a tensioning structure around and/or to a chordae tendineae or papillary muscle.
- FIG. 48A shows a side-sectional view of another tensioning structure compressed into a low profile within a deployment device for placement inside the heart cavity and attachment to the chordae tendineae and/or papillary muscle;
- FIG. 48B shows a side-sectional view of the deployed and secured tensioning structure of FIG. 48A .
- FIGS. 49A and 49B show perspective views of a heart with parts cut-out highlighting the process of deploying and securing a tensioning structure to the chordae tendineae.
- FIGS. 50A and 50B show cut-away perspective views of the heart showing the process of deploying and securing the tensioning structure embodiment of FIGS. 48A and 48B to the chordae tendineae.
- FIGS. 51A and 51B show close-up, side views of the end of a mechanism used to directly grasp, engage and reposition valve leaflets.
- FIGS. 1A and 1B an anterior view of a healthy heart in systole and diastole, respectively, is shown with directional arrows indicating motion of the heart in each phase.
- the great cardiac vein 16 is shown on the surface of the ventricle 18 of the heart.
- the great cardiac vein 16 resides adjacent to the left anterior descending artery (not shown).
- FIGS. 2A and 2B perspective views are shown of a diseased (enlarged) heart in systole and diastole, respectively.
- An infarcted or ischemic region 20 is shown to stretch from systole to diastole consistent with the progressive remodeling that occurs due to increased diastolic filling pressures exerted on the diseased tissue.
- a radial and axial expansion that is experienced by the heart leads to stretching or degenerative remodeling and concomitant organ enlargement.
- This enlargement can be localized along the anterior wall of the left ventricle, can be located or extend septally, can include the right ventricle, and/or can involve the mitral valve annulus.
- all tensioning structure aspects of the present invention comprise individually or in combination of several, components or devices including tensile member(s), anchor member(s) and deployment device(s). These components or devices are designed to be able to work in concert in order to facilitate and provide palliative or therapeutic cardiac reinforcement in the following critical target areas of the heart: 1) intravascular conduits, 2) cardiac valve annulus, 3) myocardium, 4) chordae tendineae and valve leaflets.
- the sub-sections broken-out below will further describe these specific aspects of the invention.
- a number of embodiments of the present invention are provided mainly in the context of tensioning structures positioned and anchored within intravascular conduits to provide cardiac muscle support and reinforcement.
- Such intravascular conduit tensioning structures can be designed to be interchangeably deployed within various vascular conduits (arteries, veins, and branching vessels associated with these structures); or through these conduit walls directly into or through myocardium tissue, as described below.
- the primary vascular targets for intravascular conduit tensioning structure embodiments of the invention are in the venous tree (i.e., great cardiac vein, middle cardiac vein, small cardiac vein, anterior cardiac veins, oblique veins, and the coronary sinus).
- venous structures generally run in symmetric apposition to their arterial equivalents, albeit at spaced intervals, where most myocardial infarcts originate.
- coronary artery disease such as the left anterior descending, right coronary and circumflex arteries
- the associated venous structures provide ideal target locations for catheter-based, percutaneous implantation of intravascular conduit tensioning structures to provide palliation and/or therapy.
- FIGS. 3A and 3B show perspective views of a diseased heart reinforced with intravascular conduit tensioning structure 4 of the invention.
- Tensioning structure 4 limits myocardial stretch or infarct expansion by locally reinforcing the infarcted/ischemic regions 20 or other diseased sections of tissue, and limiting the tension applied to the tissue regions 20 in conjunction with diastolic filling pressure exerted directly against this diseased section.
- an intravascular conduit tensioning structure 4 is shown deployed in the great cardiac vein 16 such that it targets ischemic or infarcted tissue 20 associated with an occluded or stenosed left anterior descending artery or its emanating branches.
- Tensioning structure 4 can also be placed directly into the artery; however, it is preferred to anchor the structure in immediately apposed veins to eliminate concerns of thrombogenicity and adverse sequelae associated with placing foreign objects into arterial structures.
- the tensioning structures can also be positioned intravascularly, but anchored to the heart by extension into or through the myocardium.
- All of the intravascular conduit tensioning structure embodiments are preferably positioned and deployed such that they extend from within the infarcted/ischemic region to tissue residing within or beyond the border region of this zone, or between spaced apart, border zone regions extending through, over, or under the infarct/ischemic zones.
- Tensioning structure 4 are capable of applying a continuous or strain limiting tensile force to resist diastolic filling pressure while simultaneously providing a commensurate compressive force to the muscle wall to additionally or alternatively limit, compensate or provide therapeutic treatment for congestive heart failure and/or to reverse the remodeling that produces an enlarged heart.
- FIGS. 4A and 4B show perspective views of hearts highlighting the remodeling that occurs over time due to the inability of the ischemic/infarcted area 20 to withstand pumping pressures.
- FIG. 4A shows the heart with diseased tissue 20 at the onset of remodeling.
- FIG. 4B also shows the result of remodeling with an aneurysmal-like bulging of tissue outward from the ischemic/infarcted area 20 .
- This remodeling disrupts cardiac output by producing zones of hypokinesis, dyskinesis and/or akinesis, which further exacerbates the burden on the heart.
- the heart tries to compensate for this remodeling to maintain cardiac output by altering the compliance, contractility, and/or heart rate; in doing so the response only accelerates or perpetuates the degeneration.
- intravascular conduit tensioning structures 4 can be secured such that they effectively cover the ischemic/infarcted area 20 and also extend across the diseased section 20 at both ends where they are anchored. Accordingly, the tensioning structure in FIG. 4C is shown anchored in the great cardiac vein 16 providing reinforcement and treatment to the weakened region 20 This provides sufficient reinforcement of the heart to regulate and withstand the internal forces that would otherwise perpetuate the remodeling process. In doing so, the tensioning structures 4 facilitate and maintain a more efficient and perhaps optimal, or at least-more optimal, wall motion throughout the cardiac cycle, thereby aiding in diastolic filling and systolic contraction at the diseased sections of the heart 20 . As such, the precursors to remodeling (such as excess strain in the weakened, diseased sections of the heart 20 during systolic and diastolic cycles) are reduced, removed and even reversed.
- precursors to remodeling such as excess strain in the weakened, diseased sections of the heart 20 during systolic and diastolic cycles
- FIGS. 5A and 5B show an anterior view of a heart with tensioning structure 4 of the invention being percutaneously deployed from a catheter delivery system 6 into the great cardiac vein 16 and the small cardiac vein 22 .
- FIG. 5A also shows tensioning structure 4 being deployed within the great cardiac vein 16 and in 5 B in the small cardiac vein 22 .
- These figures again illustrate the use of the tensioning structures to provide local reinforcement to the cardiac muscle.
- the tensioning structures according to the present invention can be deployed within these venous structures as a stand-alone therapy for congestive heart disease or in combination with adjunctive treatment of the valve annulus.
- a multitude of such tensioning structures can be deployed about the heart in various, venous conduit structures, and as required anchored at various myocardial tissue positions to provide the reinforcement required to regulate and withstand the stresses and strains that would otherwise perpetuate the remodeling process.
- More than one tensioning structure 4 can be deployed into a single coronary vein (or other vascular conduit), into or through the myocardium associated with or adjacent to the infarcted/ischemic zone(s) of the heart, or a combination of vascular and direct myocardial approaches (described below) to vary the reinforcement pattern and effect throughout the coronary bed.
- FIGS. 6A and 6B show a posterior view of the heart depicting deployment of an intravascular conduit tensioning structure 4 into the middle cardiac vein 28 and into the coronary sinus 26 to provide additional reinforcement.
- the tensioning structures 4 are shown deployed in the great cardiac vein 16 , middle cardiac vein 28 and branches 30 and 38 emanating from such veins.
- the tensioning structures are positioned and anchored distally prior to securing tensioning structures directly in the coronary sinus 26 because the distal most target vessel should be accessed first.
- anchoring in the coronary sinus could be deployed first if desired or required by the operator.
- FIGS. 6A and 6B illustrate various proximal and distal anchor configurations that are preferred for the invention.
- FIG. 6A depicts the distal deployment of an intravascular conduit tensioning structure 4 into the middle cardiac vein 28
- FIG. 6B illustrates deployment of the tensioning structure and proximal anchoring in the coronary sinus 26 with the distal anchoring in the left marginal vein 30 .
- FIGS. 7A and 7B show a detailed, cut away anterior view of two tensioning structures 4 anchored to the great cardiac vein 16 at the ventricle 24 .
- Tensioning structure 4 in FIG. 7A is shown deployed within the vein with both ends/termination secured to the vessel using anchors 32 placed transmyocardially (into or through the myocardial wall 34 ).
- the tensioning structure shown in FIG. 7A incorporates a tensile member 84 featuring an undulating sine wave section 44 , which provides an elastic or spring like loading to regulate or moderate expansion of the heart during diastole.
- this tensioning structure 4 incorporates radiopaque marker bands 36 which facilitate evaluation of cardiac performance by allowing measurement of the distance between marker bands 36 during the cardiac cycle under fluoroscopic guidance.
- the marker bands 36 could be fashioned from an echogenic material that can be located and visualized with ultrasonic imaging guidance, or otherwise similar means.
- Tensioning structure 4 in FIG. 7B is shown deployed within the great cardiac vein 16 .
- anchoring is achieved by positioning within a branch vessel 38 emanating from the great cardiac vein 16 by locating anchor 32 in the said branch vessel 38 .
- This tensioning structure also features a tapered section 40 to properly engage and deploy within a tapering vein section 42 .
- the tensioning structure design shown in FIG. 7 radially supports a portion of the vein vessel at spaced apart intervals.
- This embodiment incorporates reduced diameter sections defining flexible tensile members 84 associated with radially, curved extensions designed to lock the tensioning structure to the vasculature.
- the tensioning structure could fully support the lumen of the vein, especially at spaced apart intervals.
- Either sort of design could be fashioned from materials or processed by various means to have sections or regions of varying stiffness customized or tailored to provide optimal performance characteristics.
- FIGS. 8A to 8 E show a variety of alternate tensioning structures that can limit ischemia related myocardial stretch and infarct expansion.
- FIG. 8A shows an embodiment where the body of the tensioning structure 4 is a tensile member body 84 (e.g., tube, ribbon, strand, or wire, which can limit elongation with satisfactory elasticity based upon the selection of material properties and cross sectional area) incorporating at least one stress distribution feature such that the tensioning structure can apply tension against tissue without damaging the contacted tissue regions.
- a tensile member body 84 e.g., tube, ribbon, strand, or wire, which can limit elongation with satisfactory elasticity based upon the selection of material properties and cross sectional area
- a variety of materials can be used as the tensile member 84 of the tensioning structure, including PTFE, expanded PTFE, nylon, silicone, urethane derivatives, polyurethane, polypropylene, PET, polyester, superelastic materials (e.g., nickel titanium alloy), other alloys (e.g., stainless steel, titanium alloy etc.), metal (e.g., titanium), biological materials (e.g., strips of pericardium, collagen, elastin, vascular tissue such as a saphenous vein or radial artery, tendons, ligaments, skeletal muscle, submucosal tissue etc.) other alternate materials having the desired properties, or a combination of these and other materials.
- superelastic materials e.g., nickel titanium alloy), other alloys (e.g., stainless steel, titanium alloy etc.), metal (e.g., titanium), biological materials (e.g., strips of pericardium, collagen, elastin, vascular tissue such as a saphenous vein or
- the performance of the tensioning structure depends upon and can be tailored to the desired features. For example, when column strength is required, superelastic materials or other alloys or metals are preferred tensile member bodies 84 of the tensioning structure. When pure tension is required and the tensioning structure is to be deployed through tortuous access points, more flexible materials such as expanded PTFE, polyester, or other suture type materials may be preferred as tensile members. When absorption or biological integration is desired over a period of time, biological materials such as strips of pericardium or collagen, or absorbable materials are preferred.
- FIGS. 8A to 8 F show a variety of alternative tensioning structures of the invention.
- FIG. 8A also shows anchor members 32 secured to a tensile member 84 at both ends of tensioning structure 4 to anchor the device to and within a conduit vessel. These anchor formations. 32 can alternatively be used to anchor the device directly into or through myocardial tissue for embodiments where the tensioning structures are placed or deployed extravascularly using surgical access to the epicardium, or using a catheter-based approach into the left ventricular cavity to target the endocardium.
- Anchors 32 are preferably fabricated from biocompatible materials commonly used in medical implants including nickel titanium (especially, for self-expanding or thermally-actuated anchors), deformable stainless steel (especially for balloon-expanded anchors), spring stainless steel, or other metals and alloys capable of being deformed using balloon catheters or other expansive means, or self-expanded to secure the tensioning structure to the vasculature, myocardium, or other tissue.
- the anchors 32 can be fabricated from superelastic polymers, flexible or deformable polymers such as urethane, expanded PTFE, or stiff materials such as FEP, polycarbonate, etc.
- FIG. 8B illustrates a tensioning structure 4 that can at least impart partial radial support and be anchored to a vessel with anchors 32 .
- spaced apart anchor members are shown interconnected by tensile members 84 .
- the multiple anchor members aid with cinching/compression of the local tissue region(s) to reduce wall stress while mitigating over-expansion of the tissue.
- the multiple anchors can import or help to exert an elastic recoil effect during wall motion of the heart. That is, the tensioning structure would be fixed within the vascular conduit by frictional forces imposed upon the wall to maintain position of the structure in spite of cardiac wall motion. Therefore, the frictional fit provided by the multiple anchors along with the tensile member 84 mitigates over expansion of the heart.
- FIG. 8C shows a three-dimensional view of another embodiment of a tensioning structure 4 deployed in a vessel where the tensile member 84 geometry features an undulating pattern (e.g., a sine wave pattern). Such a pattern may be provided in order to offer partial radial support to a vessel by conforming to and following the shape of the vessel lumen.
- FIG. 8D shows another tensioning structure 4 that incorporates a tensile member 84 featuring a three-dimensional undulation or switchback (e.g., a sinusoidal pattern) that fully supports the vessel lumen.
- FIG. 8E shows a variation of FIG. 8C embodiment with the addition of anchor formations 32 .
- FIG. 8F shows an embodiment of the tensioning structure 4 configured in a specific geometry suitable for use in or about the valve annulus 108 .
- the design in FIG. 8F features switchbacks or a waveform at its center which when deployed about a valve annulus 108 can provide additional compressive radial force to the area opposite of anchors 32 .
- FIGS. 9A and 9B show various tensioning structures 4 , adapted for anchoring in branch vessels 30 .
- Anchor members 32 provided therewith can be of various geometric configurations to enable stabilization of the support structure 4 within the vessel to provide reinforcement to the heart, especially by leveraging the complex three-dimensional tortuosity of the vessel anatomy to facilitate or achieve fixation or anchoring.
- the tensioning structure embodiments shown in FIGS. 10A to 10 C feature a sine wave spring section 44 within the tensile member 84 of the structure.
- the tensile member embodiments in FIGS. 10A to 10 C provide an additional elastic section over straight members and provide another method to optimize cardiac wall motion to improve cardiac output.
- the tensile member 84 spring 44 is an undulating spiral-shape, (e.g., in the form of a sine wave).
- the tensile member 84 spring 44 is a helix.
- tensile member 84 spring 44 features a geometric pattern, which enables a lower profile compression/confinement to enabling enable more efficient delivery via percutaneous or MIS means.
- FIG. 11 an embodiment of the tensioning structure variation 4 is shown, wherein the tensile member 84 incorporates individual wire, ribbon, suture, tube, or other raw material segments 48 formed so as to interlace to and with each other.
- the segment terminations 46 are formed about the adjacent segment members creating overlap and are curled to interfere with the curled termination of the adjacent members.
- the interlaced segments 48 can expand and contract with the cardiac cycle, with the interfering terminations 46 placing a limit on the overall elongation.
- FIG. 12 illustrates an embodiment of thea tensioning structure variation 4 featuring a tensile member 84 with an undulating sine wave pattern (e.g., a sine wave pattern) formed along a cylindrical body.
- the cylindrical body shown in FIG. 12 provides complete radial support within the vessel where it is implanted. The shape also facilitates flexibility to for deployment in complex three-dimensional tortuous anatomies.
- Anchor formations 32 on both ends of tensile member 84 may be provided, in which case they will be oriented in a direction so as to resist the expansion of the heart when deployed within the vessel lumen.
- FIGS. 13A to 13 C show various, adjustable, tensioning structures 4 to provide modification or adjustability of stiffness/resistance or force outputs by incorporating means to increase or decrease flexibility of the structure.
- the device of FIG. 13A achieves the such adjustability utilizing removable loop structures 50 strategically positioned along the tensile member 84 that can communicate with the hub of the deployment system 6 enabling a physician operator to selectively disengage or remove the same to increase the flexibility of the structure.
- the device of FIG. 13B employs a ratchet mechanism 176 with spring loaded ball detents 52 along the tensile member 84 to achieve the same effect as described in 13 A.
- the (ball) detents 52 are either resilient or spring loaded so as to selectively lock within a cut out section 54 at the distal end of the catheter deployment system 6 by engaging a push/pull mechanism moving the ball detents in a relative motion to a stationary deployment system 6 sheath.
- FIG. 13C shows an embodiment similar to that in 13 B, wherein the a ratchet mechanism 176 is provided that employs a sine wave-like structure instead of spring loaded ball detents to similarly facilitate adjustability.
- FIGS. 14A to 14 D illustrate the process of constraining a tensioning structure 4 into a deployment catheter system 6 sheath.
- FIG. 14A illustrates a generic embodiment of a tensioning structure 4 containing self-expanding (e.g., superelastic) components (anchor 32 and/or tensile member 84 ) in an unconstrained, resting geometry.
- FIG. 14B illustrates the initial loading of thea tensioning structure 4 within or into the inner lumen of the deployment system 6 sheath using a hooked wire or stylet 8 to pull the structure within the lumen space.
- FIG. 14C continues the depiction of the loading of tensioning structure 4 into the deployment system 6 sheath.
- FIG. 14A illustrates a generic embodiment of a tensioning structure 4 containing self-expanding (e.g., superelastic) components (anchor 32 and/or tensile member 84 ) in an unconstrained, resting geometry.
- FIG. 14B illustrates the initial loading of the
- FIGS. 14B to 14 D shows the deployment system 6 sheath with the tensioning structure fully constrained therein.
- the process shown in FIGS. 14B to 14 D can generally be followed in reverse order with the exception that the stylet 8 pushes the tensioning structure out of the sheath once it is advanced to the desired location.
- the stylet 8 can maintain the position of the tensioning structure as the deployment system 6 sheath is retracted.
- deployment of tensioning structures incorporating deformable components will be modified in that a balloon or other expandable mechanism can be used to deform pertinent components after placing at the desired implantable location. Details of deployment of at least some of the tensioning members, given the particulars of the device, may be apparent at least to skilled surgeons, interventionalists and technicians.
- Deployment of these and other tensioning structures described below can be achieved 1) using a catheter-based approach to access the endocardium, vasculature, or epicardium; 2) surgically accessing the target site along the epicardium to insert and secure the tensioning structures, as described in later sections; or 3) using a combined surgical and catheter-based approach. Described below is the method and process of deploying tensioning structures into, within, or through the vasculature to reinforce the left ventricle about an infarcted/ischemic region, the mitral valve annulus to address mitral regurgitation or other insufficiencies, or other anatomy.
- this deployment process can be modified to enable positioning these tensioning structures intravascularly and then anchoring directly into or through the myocardium (or other tissue) to reinforce the anatomy without being confined to the vasculature.
- the deployment process can also be modified to enable positioning of these tensioning structures extravascularly with anchoring directly into or through myocardium (or other tissue) to reinforce the anatomy without being confined to the vasculature.
- FIGS. 6A and 6B The percutaneous approach to deliver and deploy a tensioning structure is illustrated in FIGS. 6A and 6B .
- an introducing sheath or guiding catheter 5 as described above, is percutaneously inserted into the right atrium 58 such that the distal end of the delivery device enters the coronary sinus 26 .
- the delivery system catheter 6 can then be inserted through this introducing sheath such that it enters the venous system of the heart, and facilitates access to the target vessel at which tensioning/support structure 4 selected is to be deployed.
- the tensioning structure can take various forms such as shown in FIGS.
- FIGS. 14A, 14B and 14 D show proper securing of a tensioning structure according to the invention into a coronary vein after withdrawal of the delivery system catheter.
- a fluoroscopic marker and/or ultrasonic markers can be used to designate the side of the delivery system catheter in which the inner surface of the tensioning structure resides, thereby demarking the surface in which the tensioning structure curves.
- FIGS. 15A, 15B , 16 A, 16 B, 17 A, 17 B, 17 C, 18 A and 18 B provide alternative anchor types that can be deployed into the myocardium 34 itself, or though the myocardium and against the endocardium or epicardium of the proximate ventricle or atrium to provide interference with surrounding tissues to achieve the desired attachment.
- FIGS. 15C, 15D , 17 D, 17 E, 18 C, and 18 D provide additional anchor designs that can be deployed within the vessel lumen, through the vessel wall, into the myocardium, or through the myocardium and against the endocardium or epicardium or combinations thereof.
- FIGS. 15A to 15 D, 16 A, 16 B, 17 A to 17 E, and 18 A to 18 D show various embodiments of anchors in constrained and expanded forms or states.
- FIG. 15A and 15C show a constrained anchor 32 which when expanded takes the form of a helix spiral or screw as shown in FIG. 15B and 15D respectively.
- FIGS. 16A and 16B show an anchor formation 32 that features an expandable disc configuration.
- FIG. 16A shows a view of the disc in a constrained configuration and 16 B show the expanded form of the same.
- the disc structure of the anchor formation in this embodiment may employ polymeric or metallic coverings attached to the anchor formation 32 .
- FIG. 17A shows a collapsed/constrained view of a hook like wire structure that can engage tissue.
- FIG. 17B or 17 C shows a hook-like structure similar to that in 17 A in a constrained state with an expanded state subsequently shown in FIG. 17E .
- FIGS. 18A to 18 D yet another variation of a hook-like anchor 32 is shown, in which a plurality of hooks is employment to increase the anchoring strength by distributing load among the hooks.
- anchor formations can be fabricated from superelastic materials to self-expand into contact with tissue structures or otherwise such as with deformable materials that require a balloon or other expanding device to deform the anchor formations into an enlarged, deployed state causing the anchor features of the anchor formations to expand into engagement with tissue structures capable of securing the tensioning structure at each end.
- the anchors 32 can be fabricated from superelastic polymers, deformable polymers, or rigid materials, depending on the anchor design and required dimensions.
- An enlarged heart can also be associated with valvular dysfunction and disorders.
- valvular leaflets can begin to separate and result in incomplete closure, incompetence and blood regurgitation further exacerbating the degenerative cycle of failure of the heart.
- the present invention offers a solution for this disorder by the use of the tensioning structures in vascular conduits about the annulus of the valve to apply radial, tightening forces to restore valvular function by decreasing the annulus diameter and the related stress.
- the variations of the invention described in the section are well suited for use in annulus reinforcement at the primary vascular targets in the venous tree (i.e., coronary sinus 26 , great cardiac vein 16 , and middle cardiac vein 28 ) especially since the coronary sinus anatomically navigates the atrioventricular groove 178 defining the mitral valve annulus 108 as seen in FIG. 22A .
- This particular target location provides an ideal location for implantation of tensioning structures to provide palliation and/or therapy.
- the tensioning structures described in this section are capable of applying continuous or strain limiting tensile force to resist diastolic filling pressure at the cardiac valve annulus to provide therapeutic treatment for valve incompetency, its associated detrimental role in the congestive heart failure syndrome and/or to reduce the rate of or reverse the remodeling that produces an enlarged annulus or heart chamber.
- a perspective view of a heart is shown with the coronary sinus 26 and right atrium 58 , adjacent the inferior vena cava 78 , broken in sections.
- the coronary sinus 26 is shown along the atrioventricular groove 178 of the heart.
- the coronary sinus 26 partially negotiates the mitral valve and enters the right atrium at an ostium 76 located between the inferior vena cava 78 and the tricuspid valve 180 .
- Access to the coronary sinus 26 during percutaneous catheterization involves inserting an introducer sheath into a vein (e.g., femoral vein, subclavian, etc.) and feeding a catheter, under fluoroscopy or other imaging means, into the right atrium.
- a vein e.g., femoral vein, subclavian, etc.
- An abrupt curve in the catheter, or steerability incorporated in the catheter or other separate guiding device, allows for feeding the end of the catheter through the ostium 76 and into the coronary sinus 26 .
- the tensioning structure 4 is advanced through the catheter or another guiding device, or positioned into the coronary sinus over the catheter (e.g., balloon catheter) into the desired positions within the coronary sinus (or other target vessel), and secured.
- FIG. 20 a perspective view is shown of a heart with the right atrium 58 and right ventricle 58 shown broken in sections exposed.
- the right ventricular outflow tract 72 (RVOT) is shown as a potential securing location for the a tensioning structure 4 .
- Other proximal anchoring locations include the fossa ovalis 182 , the ostium 76 of the coronary sinus 26 , the inferior vena cava 78 , the superior vena cava 80 , the right atrial appendage (not shown), the left atrial appendage (not shown), and the trabeculated tissue of the right ventricle 58 .
- the tensioning structure 4 can be anchored into or through the right atrial free wall 184 or the right ventricle 24 by attaching the proximal end of the tensioning structure to the myocardium or along the epicardial surface.
- the tensioning structure 4 can be passed through the right atrium or right ventricle, and anchored to the left ventricle or left atrium to provide further, more complete coverage of the tensioning structure around or about the mitral valve annulus.
- a similar approach can be used to cinch, reinforce, or repair the tricuspid valve annulus 108 .
- FIG. 21 shows a perspective view of a heart 186 whose mitral valve annulus 108 is reinforced with a tensioning structure 4 embodiment of the invention, with the device positioned and anchored to limit expansion of the mitral valve and also to tighten the mitral valve.
- the tensioning structures 4 reduce radially, stiffen, and/or support the mitral valve by cinching the annulus similar to tightening as a purse-string; the tensioning structures also limit the localized forces exerted directly against the valve annulus.
- the tensioning structure 4 is again shown deployed in the coronary sinus 26 such that it navigates the mitral valve annulus.
- the distal end 188 of the tensioning structure 4 is secured in the coronary sinus, great cardiac vein, or other branching vessel by an anchor 32 , adapted for engagement to or through venous tissue, to which the tensile member 84 is secured (or integrated).
- the proximal end 190 of tensioning structure 4 is secured at the right ventricular outflow tract 72 (RVOT) with another anchor 32 adapted for attachment to this specific attachment site.
- RVOT right ventricular outflow tract 72
- a stent anchor having a significantly larger expanded diameter can be inserted into the RVOT and expanded (using a balloon or via self-expansion) to lock the proximal end 190 of the tensile member 84 .
- annulus supports that do not extend the reinforcement device into engagement with or beyond the ostium may provide insufficient coverage around the mitral valve annulus because the attachment position and the length of the anchoring modality within the coronary sinus dramatically reduces the angular coverage around the mitral valve annulus.
- tensioning structure 4 securing the proximal end of tensioning structure 4 to the RVOT 72 allows for reinforcing a larger amount of the mitral valve annulus since the tensioning structure is able to reinforce the valve annulus 108 from the great cardiac vein 16 , along the coronary sinus 26 , past the ostium 76 into the right atrium 58 , along the interatrial septum 192 , past the tricuspid valve 180 , into the right ventricle 24 , and terminating at the RVOT 72 , as illustrated in solid and broken line
- the guiding catheter or introducing sheath used to position the tensioning structure into the coronary sinus can be placed through the right atrium or right ventricle during surgical access to the interior of the right atrium.
- the catheter can be percutaneously placed and be advanced through the right atrial appendage (not shown) or right ventricle 24 from the inside of the chest cavity.
- the introducing sheath can be retracted, thereby allowing the proximal end of the tensioning structure to expand into the myocardium or against the epicardium of the right atrium or right ventricle.
- the proximal anchor mechanism can be manually set by deforming the same using a balloon or other expansion mechanism, as described below.
- the proximal anchoring mechanism can be manipulated into contact with the left atrium or left ventricle and secured, also to provide increased coverage of the tensioning structure around the annulus.
- the guiding catheter or introducing sheath used to position the tensioning structure into the coronary sinus can be used to position the proximal anchoring mechanism into or through the myocardium of the right atrium or right ventricle. Additional features can be required for this approach including a puncturing mechanism to penetrate into or through the myocardium, as will be described below.
- FIG. 22A shows a side view of the heart open in sections, with a tensioning structure 4 secured within the coronary sinus 26 with a distal anchor (not shown) and a proximal anchor 32 attached at the ostium 76 into the coronary sinus 26 .
- the distal anchor can comprise one of the various anchor formations described in the preceding sections of the detailed description.
- the tensioning structures 4 of the invention generally extend into engagement with or beyond the ostium 76 of the coronary sinus, thereby covering the mitral valve annulus from the great cardiac vein 16 past the coronary sinus ostium 76 . This significant amount of coverage provides sufficient reinforcement to the annulus to regulate and withstand the internal forces that would otherwise perpetuate the remodeling process and/or adversely affect valve competency.
- proximal anchor 32 Securing the tensioning structure 4 proximal end at the ostium of the coronary sinus is facilitated by a device design including a stop feature integrated with the proximal anchor 32 to prevent migration of the tensile member 84 back into the coronary sinus.
- proximal anchors 32 can be, for example, plastically deformable from a small diameter to an enlarged profile (using a balloon expandable catheter) to allow positioning part of the anchor in the right atrium outside the periphery of the orifice 76 thereby acting as a stop which interferes with the atrial wall to prevent the anchor from dislodging into the lumen of the coronary sinus.
- the proximal anchors 32 can be fabricated from superelastic material capable of elastically deflecting into a low profile for deployment and returning towards a preformed shape once external compressive force is removed. This preformed shape could provide the required interference at the ostium as well.
- FIGS. 22B to 22 F A minimally invasive surgical approach for deployment of the present embodiment is provided in FIGS. 22B to 22 F.
- These figures show a tensioning structure 4 that has its proximal end 190 secured through the right atrium and against the right ventricular epicardium.
- the tensioning structure can be deployed using a catheter delivery system capable of puncturing through the right atrium 58 from inside the heart to deploy and secure the proximal anchor after positioning the distal anchor.
- a surgical approach may be to puncture the right atrium from the epicardial surface and then place a delivery system catheter 6 into the coronary sinus.
- the delivery system catheter After deploying and securing the distal anchor 32 , the delivery system catheter is retracted past the insertion site leaving the tensioning member 84 behind in the coronary sinus 16 and right atrium 58 .
- a purse-string can be used to ensure hemostasis at the insertion site, around the delivery catheter during deployment of the distal anchor or around the tensile member 84 after removing the delivery catheter.
- the proximal anchor 32 is then engaged and secured against the insertion site 194 , the right atrium 58 , the right ventricle 24 (as shown in FIG. 22F ), the left atrium 74 , the left ventricle 18 , or other anatomic structure capable of maintaining tension to the tensioning member 84 . It should be noted that the same approach can be used to deploy the tensioning structure through the right ventricle 24 , the inferior vena cava 78 , the superior vena cava 80 , or other anatomy.
- FIG. 23 shows a side-sectional view of a coronary sinus 26 (or other vessel) that overlays or is otherwise in close proximity to a coronary artery (or other vessel) with a tensioning structure 4 positioned and secured within the coronary sinus.
- the spaced apart distal anchors 32 of the tensioning structure are short relative to the length of the coronary sinus (or other target vessel) and are interconnected by the more flexible tensile member 84 , so they can be positioned and secured away from the overlaying vessel 82 . That way, the tensioning structure does not occlude the overlaying vessel.
- More than two anchors 32 can be used to further distribute the forces along the coronary sinus (or other vessel) and ensure overlaying vessels are not compromised once the tensioning structure is secured. By placing anchors on each side of the overlaying vessel 82 , the coronary sinus is supported throughout this region to ensure the tightening, or compressive forces exerted by the tensile member 84 do not constrict the overlaying vessel 82 .
- FIG. 24 shows a perspective view of a heart 2 cut away broken along the right atrium 58 and right ventricle 24 with another tensioning structure embodiment 4 deployed within the coronary sinus 26 and having the proximal anchor 32 secured to the RVOT 72 .
- the proximal anchor 32 is fabricated as a tubular member or spiral component configured to contact the RVOT 72 throughout a cross-sectional region of tissue
- the embodiment in FIG. 24 shows a proximal anchor 32 defining a hook or pigtail capable of taking advantage of the tortuosity of the RVOT 72 relative to the coronary sinus which grapples or engages onto or within the RVOT 72 .
- FIG. 25 shows a perspective view of a cut-away heart with a tensioning structure positioned within the coronary sinus 26 and secured to the ostium 76 with the use of a balloon expandable stent (or self-expanding stent) as the proximal anchor 32 .
- the fully expanded diameter of the stent (anchor 32 ) is larger than the inner diameter of the coronary sinus 26 to ensure that the stent does not migrate back into the coronary sinus 26 upon deployment. This ensures that the forces, which are applied when deploying the tensioning structure, are maintained continuously.
- proximal anchor configurations are easy to deploy since, after securing the distal anchor, tension is applied to the tensile member 84 by retracting the proximal anchor until the appropriate tightening or cinching of the valve annulus is achieved; at this position, a balloon can be used (for balloon expandable proximal anchors) to over-expand the proximal anchor such that the region outside the coronary sinus orifice has a substantially larger outer diameter than the inner diameter at the orifice.
- This configuration permanently locks the tensioning structure in the plastically-deformed position.
- Self-expanding proximal anchors can be released from an external, compressive sheath that maintains the anchors in a compressed, low profile state during positioning pre-deployment.
- proximal anchors can be configured to be used at any vessel ostium that is to be reinforced. It should also be noted that other expandable (balloon deformable or self expanding) anchor configurations can be used at the orifice with or without barbs that actively engage the interior surface of the tissue (i.e., right atrial wall).
- FIGS. 26A to 26 D show side-sectional views of vessels 56 containing the distal anchor region of a tensioning structure illustrating various attachment points between the tensile member 84 and anchor 32 .
- FIG. 26A shows an embodiment where the tensile member 84 is bonded to the near, inside edge 196 of the anchor 32 .
- FIG. 26B shows an embodiment where the tensile member 84 is bonded to the far, inside edge 197 of the anchor 32 .
- FIG. 26C shows an embodiment where the tensile member 84 is bonded to the near, outside edge 198 of the anchor 32 .
- FIG. 26D shows an embodiment where the tensile member 84 is bonded to the far, outside edge 199 of the anchor 32 .
- the tensile member can be bonded to any region of the anchor 32 as required or desired.
- Suitable fixation methods to join the tensile member 84 to the anchor 32 include chemical bonding, tying, welding, adhesive bonding, mechanical crimping, combinations thereof or any other suitable fixation means.
- the anchor When the anchor provided used is a stent like anchor formation (balloon expandable or self-expanding), as shown in FIGS. 26A to 26 D, the anchor preferably has a length that is preferably more than 1.5 times the inner diameter of the target vessel (e.g, coronary sinus). Stent-like anchors are most suitable for small and medium diameter vessels, such as the coronary sinus; other anchors may be better suited for other attachment points, such as the RVOT 72 . The location of the bond/attachment between tensile member 84 and anchor 32 , as shown in FIGS.
- the target vessel e.g, coronary sinus
- 26A to 26 D ensures stability of the anchor as tension is applied because tension causes the anchor to slightly rotate in the target vessel increasing the engagement of the anchor to the target vessel and preventing axial dislodgement. If the tensile forces are applied in a purely axial manner, instead of providing some torque, then the risk of dislodgment increases, but since a slight rotation is caused by tension and the length of the anchor is greater than the inner diameter, the anchor pull-out forces increases as applied tension to the anchor increases.
- the tensile member 84 can be integrated to the anchor as opposed to being bonded or joined as separate components.
- these anchors can be fabricated from one or more strands of material that form a helix, mesh, open cell, or other anchor geometry and emanate into one or more strands that produce the tensile member.
- any anchor configuration can be bonded/attached to a tensile member to form these two components of the tensioning structure.
- tensile member 84 It will often be preferred to maximize flexibility of the tensile member 84 to aid in the traversal of tortuous anatomy in order facilitate percutaneous and/or minimally invasive surgical approaches structure of deployment. Accordingly, materials that are most suited to fabricate tensile member 84 will have a high degree of flexibility in the bending direction or, otherwise stated, have zero or minimal buckling resistance. In addition, this preferred material should have resistance to tensile elongation unless elasticity is a desired component for the tensile members, in which case, the tensile member enables temporary elongation with corresponding recoil. Materials that creep are not preferred since they might prompt the need for undesired, post-surgical tensioning structure adjustment.
- FIGS. 27A to 27 C show close-up views of three anchor configurations 32 and the attachment of non-integrated tensile members 84 to the anchors.
- FIG. 27A shows an anchor 32 formed from a mesh or braid of raw material strands and a tensile member tied to the intersection of the strands.
- tensile member 84 can be glued, ultrasonically welded, spot welded, soldered, or bonded with other means, depending on the types of materials used.
- the anchor(s) 32 and/or tensile member(s) 84 can be fabricated from metallic materials such as stainless steel, nickel titanium, titanium, or other metal or alloy; superelastic polymers; biological materials such as pericardium, collagen, submucosal tissue, skeletal muscle, and vascular tissue (e.g., saphenous vein, radial artery, or other artery or vein), genetically engineered tissues; or other materials such as nylon, polyester, polypropylene, expanded PTFE, polyimide, silicone, PET, polyurethane, urethane composites, thermoplastic materials, thermoset plastics, composites of such materials, or other biocompatible material.
- metallic materials such as stainless steel, nickel titanium, titanium, or other metal or alloy
- superelastic polymers such as pericardium, collagen, submucosal tissue, skeletal muscle, and vascular tissue (e.g., saphenous vein, radial artery, or other artery or vein), genetically engineered tissues; or other materials such as nylon
- 27B shows an anchor 32 fabricated from a tube or other raw material geometry laser cut into the desired pattern of cells and other features with a tensile member 84 bonded thereto. It should be noted that laser cutting, chemical etching, water-jet cutting, or other cutting mechanism can be used to create the anchor and the tensile member as an integrated unit from a single piece of raw material (tube stock, sheet stock, or other geometry).
- FIGS. 28A to 28 M illustrate various anchor 32 embodiments with attached or integrated tensile members 84 .
- FIG. 28A shows an anchor 32 with radial protrusions to further embed the anchor into the target vessel wall and increase the pull-out forces as tension is applied through the tensile member 84 .
- FIGS. 28B to 28 F show alternative anchor embodiments with bonded or integrated tensile members 84 that incorporate radially extending elements ideally suited for the proximal anchor configured to be secured to the ostium of the coronary sinus (or other target vessel), the trabeculae of the right ventricle, the interatrial septum, the inferior vena cava, the superior vena cava, or the RVOT 72 .
- the anchor embodiments in FIGS. 28A to 28 F can also be used to secure tensioning structures 4 within the myocardium or against the epicardial or endocardial surface during surgical or catheter based reinforcement procedures where the tensioning structures 4 are positioned into or through myocardium
- FIGS. 28G and 28H show alternative anchor embodiments with attached or integrated tensile members ideally suited for attaching to any size vessel (e.g., coronary sinus 26 , RVOT 72 , inferior vena cava 78 , superior vena cava 80 , etc.), the ostium to the target vessel, the fossa ovalis, or other anatomic structure.
- the anchor embodiments in FIGS. 28G and 28H can also be used for tensioning structures 4 that are inserted through myocardial tissue where the anchor members abut the endocardial or epicardial surface, depending on placement location of the tensioning structures, and do not further penetrate into or through the endocardial or epicardial surface engaged to secure the anchor.
- 28I to 28 M show additional anchor embodiments with secured or integrated tensile member(s) suited for any size vessel. These embodiments directly engage the vessel and partially or completely penetrate into the vessel wall to secure the tensioning structure. Again, all of these anchor embodiments can be used to secure tensioning structures 4 into or through myocardial tissue for indications where the tensioning structures are used to reinforce an infarcted/ischemic zone by passing tensioning structures along or through the zone from outside the border of the zone into the region of the zone, or from opposing sides of the zone passing through the infarcted/ischemic zone.
- FIG. 29 shows an embodiment of the proximal anchor that incorporates a mechanism to variably tighten the tensile member 84 relative to an anchor.
- a ratcheting mechanism is shown with elastic balls or other teeth-like mechanisms able to retract in one-direction to increase tension applied to the tensile member 84 and prevent release of the tension applied.
- Such a mechanism enables variably adjustment and tightening of the annulus, or other tissue region, intraoperatively and postoperatively as the tissue heals and recovers.
- an introducing sheath or guiding catheter can be percutaneously inserted into the right atrium 58 such that the distal end enters the coronary sinus 26 .
- the delivery system can be inserted directly through the right atrium. (e.g., at the right atrial appendage) or the right ventricle to access the coronary sinus during surgical procedures.
- a catheter-based delivery system approach would involve insertion through an introducing sheath positioned in the femoral vein into the venous system of the heart such that it facilitates access to the target vessel into which the tensioning structure 4 is to be deployed.
- the tensioning structure can take various forms as described above all of which can be preloaded in the deployment catheter prior to insertion into the vasculature.
- the delivery system catheter is a balloon catheter capable of expanding with pressure to an enlarged diameter forcing the tensioning structure anchor (especially those with stent-like characteristics) radially outward into engagement with the interior surface of the vessel or other associated anatomy.
- other anchors can be sequentially (or simultaneously) deployed with the same or other balloons.
- the anchors can be self-expanding and constrained within a guide catheter used for deployment.
- a stylet or multiple stylets can be used to sequentially or simultaneously deploy the anchors as tension is applied.
- balloon expandable and self-expanding anchors can be utilized on the same tensioning structure and the deployment catheter can incorporate balloon catheters and guiding catheters collaborating to deploy the anchors at targets.
- a fluoroscopic marker and/or ultrasonic markers can be used to designate the side of the deployment catheter in which the inner surface of the tensioning device resides; this demarks the surface in which the tensioning structure curves.
- the endovascular approach to remotely access the target sites eliminates the need for traumatic or more invasive surgical methods to access the target structures.
- the incision to facilitate positioning and subsequent delivery and deployment of the support structures is minimal, most likely with only local anesthesia, and accordingly the procedure can be conducted on an outpatient basis.
- the technique typically involves navigating the distal end of a catheter along a tortuous path extending along the lumens defined by the patient's vasculature between a point of entry into the patient's body and the remote target site.
- the delivery system and process for placement of the anchors 32 can also feature means to facilitate adequate fluoroscopic visualization of vessel structures where the structure is to be positioned to ensure optimal performance.
- the ideal design for such a delivery system is to include a lumen at the distal tip of such means having sufficient cross-sectional area to facilitate suitable flow rates for injections of conventional contrast media used in standard interventional catheterization procedures.
- the lumen exit at the distal tip can be arranged so as to communicate along the length of the catheter body such that the proximal end can be connected to manual or automatic injection means, allowing the operator to hydraulically force the contrast media through the luminal space within the catheter.
- the contrast can then exit at the distal end of the catheter at the luminal opening or port and flow into the blood stream.
- the injected contrasted would then enable kinetic visualization and mapping of the vasculature as it flows with the blood when monitored under a fluoroscope.
- the ability to image at the distal tip of the deployment means is also ideal since the apposition of the anchor 32 relative to the vessel wall can be well characterized prior to application of tension. Also, the anchor 32 and the surrounding vessel wall can be assessed for damage to the wall due to catheter manipulations, deployment of the anchor 32 , or damage at the anchor 32 itself.
- FIG. 30 shows a cross-sectional view of a representative distal tip 86 of a delivery system catheter capable of deploying the tensioning structure, illustrating the expandable balloon 92 , a balloon expandable anchor formation 32 , a lumen for contrast injection 88 , and a guide wire lumen 90 .
- the lumens can be configured in various geometries using standard plastic processing techniques such as extrusion.
- the guide wire lumen 90 is located at the center of the catheter to facilitate coaxial delivery of the delivery catheter over standard guide wires in the preferred embodiment.
- the contrast lumen 88 can be positioned to exit at the tip or cut out of the sidewall of the lumen.
- the contrast lumen 88 diameter should be ideally sized to allow sufficient flow rates to inject radiopaque contrast media using standard interventional technique.
- FIG. 31A shows the distal segment 86 of the delivery system catheter in a vessel prior to deployment of a distal anchor 32 .
- the unexpanded balloon 92 with an anchor 32 crimped over its outer surface is shown traveling over a guide wire 94 to the distal vessel segment deployment target.
- FIG. 31B displays the expansion of the expandable balloon 92 inflated preferably with saline to deploy (i.e.,plastically deform) the anchor 32 against the inner lumen of the vessel.
- FIG. 31C exhibits the retraction of the delivery catheter (in the direction of the arrow shown in the illustration) leaving the deployed anchor 32 behind at the vessel target location with tensile member 84 attached and extending proximal to the anchor.
- the tensile member 84 can be housed within the guide wire lumen 90 , contrast lumen 88 , a lumen of it's own (not shown), or outside the catheter to facilitate smooth, untangled delivery of the tensile member 84 .
- FIGS. 32A, 32B , and 32 C shows the deployment of a proximal anchor 32 into the ostium of the coronary sinus located within the right atrium 76 .
- the anchor 32 is of the self-expanding variety and is shown with a retractable sheath system at the distal tip of the delivery system catheter 86 . This system facilitates deployment and constraining of the anchor by the operator.
- the delivery system catheter tip is shown with the tensile member 84 extending beyond the distal tip of the catheter. The termination of the tensile member is configured for attachment to a balloon expandable anchor 32 as shown in FIG. 31C or alternatively to a self-expanding anchor structure 32 as shown in FIG. 32C .
- FIG. 32B displays the self-expanding anchor 32 structure partially deployed in the coronary sinus 26 .
- FIG. 32C displays the self expanding anchor structure 32 fully deployed within the ostium 76 with a flared or trumpeted end to enable mechanical lock up to fully secure the tensioning structure at the ostium.
- FIG. 33A and FIG. 33B show cross-sectional areas of a coronary sinus 26 (or similar conduit) and the tensile member 84 .
- FIG. 33A shows a smaller contact surface area 164 of the tensile member 84 to the inside wall of the coronary sinus 26 than that of FIG. 33B .
- a larger contact surface area 164 provides a means to reduce the stress from the loading of the tensile member 84 to the coronary sinus 26 and other adjacent venous structures to minimize the propensity for abrasion/trauma to or through the vessel wall.
- the tensioning member 84 of the tensioning structure 4 described above can be fabricated from a rectangular or ovalized strip of flexible tensioning material such as expanded PTFE, FEP, polypropylene, PET, polyester, nylon-based materials, silicone, urethane derivatives, absorbable materials, cellulose acetate, regenerated cellulose, biological materials (e.g., pericardium, submucosal, saphenous vein, other vein or artery, skin, tendon, other collagen based material, strips of skeletal muscle, etc.).
- flexible tensioning material such as expanded PTFE, FEP, polypropylene, PET, polyester, nylon-based materials, silicone, urethane derivatives, absorbable materials, cellulose acetate, regenerated cellulose, biological materials (e.g., pericardium, submucosal, saphenous vein, other vein or artery, skin, tendon, other collagen based material, strips of skeletal muscle, etc.).
- tensioning member 84 When metals or alloys are used as the tensioning member 84 , they can be fabricated into a mesh, helix, sinusoid, elliptical bar, rectangular bar, or other geometry designed to distribute the stress applied to the vessel wall or other tissue structure when tension is applied to tighten the annulus or otherwise apply forces to the vessel or other tissue. Alternatively, a jacket of these same materials can be coaxially arranged over an inner tensile member component to achieve the same effect.
- FIGS. 34A to 34 E and 35 A to 35 D show additional proximal anchor embodiments capable of securing the tensioning structure to the coronary sinus orifice. These embodiments show tightening capabilities described in FIG. 29 above.
- FIG. 34A and 34B show a split wall anchor 166 designed to plastically deform into an expanded orientation partially within the coronary sinus and partially expanded beyond the outer diameter of the coronary sinus orifice to prevent movement or relaxation of the tensioning structure.
- a ratcheting or ball locking mechanism is incorporated in the side of the anchor such that as the tensioning member 84 is retracted relative to the anchor, the tensioning member becomes incrementally tighter as the locking balls or teeth are pulled into the mating latch of the anchor.
- This embodiment can alternatively be fabricated as a self-expanding anchor by utilizing superelastic components that transform into or maintain their austenite phase during deployment.
- FIGS. 34C and 34D show a laser cut anchor locking mechanism pre- and post-forming.
- the anchor embodiment in FIG. 34E incorporates the formed locking mechanism 168 in FIG. 34D attached to the anchor mechanism, in this case a balloon expandable (or self-expanding) stent.
- the locking mechanism 168 in FIGS. 34D and 34E consists of radial extensions cut into the raw material as shown in FIG. 34C defining a one-way deflectable lock allows that a tensile member containing ratcheting teeth, balls, or other mechanism to move one way while inhibiting movement in the opposite direction.
- FIG. 34C shows a laser cut anchor locking mechanism pre- and post-forming.
- the anchor embodiment in FIG. 34E incorporates the formed locking mechanism 168 in FIG. 34D attached to the anchor mechanism, in this case a balloon expandable (or self-expanding) stent.
- the locking mechanism 168 in FIGS. 34D and 34E consists of radial extensions cut into the raw material as
- 34E shows the completed anchor assembly 32 which defines a mesh or open cell stent-like anchor (plastically deformable or self-expanding) capable of anchoring the tensioning structure to the coronary sinus orifice and orienting the mesh or open cell structure to produce a locking mechanism capable of engaging and restraining the ratchet teeth, balls, or other locking mechanism of the tensile members.
- a mesh or open cell stent-like anchor plastically deformable or self-expanding
- FIGS. 35A to 35 D show another anchor embodiment capable of securing the tensioning structure to the coronary sinus orifice and incorporating a latching mechanism capable of engaging and locking mating components (teeth, balls, or other feature) of the tensile member 84 to enable manual tightening or adjustment of the tensioning structure once deployed.
- FIGS. 35A and 35B show a side view and a perspective view of an anchor containing a self-expanding (or plastically deformable) anchoring loop or loops 156 capable of engaging the right atrial, endocardial surface immediately adjacent to the coronary sinus orifice to prevent migration of the anchor into the coronary sinus once deployed and tension is applied.
- the housing that holds the anchoring loop 156 preferably constructed from a material that provides spring-like properties.
- the groove and slot shown in FIGS. 35A and FIG. 35B would act in combination as a living hinge 154 facilitating passage of the ball detents 52 or knots 102 .
- the inner conical lead-in 170 in combination with the living hinge 154 allows unidirectional ratcheting.
- FIG. 35C shows the tensile member 84 with locking features (in this case, balls 52 that engage the mating locking mechanism 168 of the anchor) being pulled through a channel to move toward the orifice thereby applying tension to the tensioning structure while preventing movement of the tensioning element in the opposite direction.
- FIG. 35D shows additional features of the deployment system.
- the guiding catheter contains a channel through its side wall for the tensile member to pass such that tension can be applied through the guiding catheter whereby the distal segment of the guiding catheter can stabilize the anchor while applying the desired tension to ensure the tensioning member locking mechanism engage the mating components of the anchor.
- This channel through the sidewall can also incorporate a blade (movable or stationary) capable of cutting the excess tensile member after the tensioning structure is deployed and tightened in place.
- the deployment systems and tensioning structures described above for reinforcing a mitral or tricuspid valve annulus can alternatively be used to reinforce infarcted and ischemic zones by positioning and securing tensioning structures intravascularly, as described previously, or directly into or through myocardium, as described below.
- the tensioning structures 4 described above can additionally be positioned through or into myocardium to locally reinforce infarcted/ischemic zones and maintain wall motion adjacent to and throughout those zones. This aids cardiac output by increasing the left ventricular ejection fraction and wall motion throughout the heart thereby improving efficiency and reducing the effects of congestive heart failure aiding the process of reverse remodeling.
- the delivery systems described above can additionally be used to insert the anchors of the tensioning structures into or through myocardium where they engage the myocardium, the epicardium, or the endocardium and attach the tensioning structures to the heart.
- These delivery systems can percutaneously access the desired attachment site through a catheter-based approach where a guiding catheter is passed retrograde through the aorta and into the left ventricle, transeptally through the interatrial septum from the right atrium and past the mitral valve into the left ventricle, or through the right atrium past the tricuspid annulus and into the right ventricle.
- the tensioning structures are individually deployed into engagement with trabeculae or other endocardially located anatomic structures, through the endocardial surface into the myocardium, or through the myocardium where they engage the epicardial surface.
- the catheter-based or minimally invasive surgical approaches can access the epicardial surface by puncturing the right or left atrial appendage (which can be closed after the procedures), the inferior or superior vena cava, or other venous structures that can be closed readily after performing the procedure.
- the tensioning structures are deployed through the epicardial surface into the myocardium or through the myocardium into engagement with the endocardium.
- the delivery systems described above can also be used to deploy the tensioning structures through a thoracotomy, thoracostomy, subxiphoid access, median sternotomy or other surgical access. This way the deployment system can access the heart along the epicardium or endocardium and position the tensioning structures at the desired locations in the heart.
- tensile member 84 terminating at anchor mechanisms 32 at each end.
- the embodiments described below are specially configured to be positioned into or through the myocardium and define anchor mechanisms augmented by the inherent structure and deployment process and/or can incorporate one or more anchors to aid in positioning and securing the tensioning structures 4 in place.
- FIGS. 36A to 36 D show a delivery system capable of simultaneously and/or independently inserting opposite ends or terminals of a tensioning structure through or into myocardium via a catheter-based or surgical approach.
- the discussion for this embodiment is described from a surgical approach initially inserting the tensioning structures through the epicardium to access the myocardium; although it should be noted that a catheter-based approach can be utilized with these embodiments if modified for percutaneous access and fluoroscopic visualization requirements facilitating insertion of the tensioning structures either through the endocardial surface to access to or through the myocardium.
- 36A to 36 D involves a pair of puncturing devices fabricated from superelastic materials (e.g., nickel titanium), metals (e.g., titanium) or other alloys (e.g., spring stainless steel) exhibiting sufficient elasticity and spring characteristics to compress into a low profile for insertion through a tissue surface and controllably expand as the puncturing devices are extended beyond the confines of the sheath used to apply the external force to compress the puncturing devices.
- the delivery system embodiment in FIGS. 36A and 36B show the puncturing devices compressed into a low profile inside a sheath (single lumen or multi-lumen with a dedicated lumen per puncturing device) having sufficient radial strength and column strength to straighten the puncturing devices.
- Each puncturing device incorporates a holder that engages a free end of the tensile member 84 of the tensioning structure, and advances or retracts the tensile member 84 as the puncturing device is advanced or retracted.
- This delivery system enables placing an independent tensile member 84 (without anchors) into or through myocardium and securing it to apply tension along an infarcted/ischemic zone to reinforce the zone. As implanted, the tensile member can contract and expand in conjunction with the wall motion about the border of the infarcted/ischemic zone.
- FIGS. 36E to 36 H show perspective and side views of two, 3-dimensional, cinching, tensioning structure embodiments that inherently define anchors at each end of the tensioning structure.
- These embodiments comprise at least one tensile member 84 (in these embodiments, only one tensile member is shown) supporting at least one stress distributing tube either secured 146 or movable 148 in relation to the tensile member 84 .
- the stress distributing tubes, secured 146 to the tensile member 84 are located at the proximal end naturally forming a loop when opposite sides of the tensile member 84 are positioned at spaced apart insertion sites. This loop forms an anchor 96 and the secured 146 stress distributing tubes prevent highly localized stress from being applied against the tissue surface at the insertion or exit points of the tensile member 84 .
- the secured 146 stress distributing tubes are located at the insertion sites for the proximal anchor 96 and the exit sites for the sides 98 and 100 of the tensile member 84 .
- the stress distributing tubes locally increase the stiffness of the tensioning structure at the insertion and exit sites to direct the tension applied to the tissue region between the stress distributing tubes.
- the secured 146 stress distributing tubes increase the surface area of the tensile member at the insertion and exit sides to distribute the force applied against the tissue along a larger surface area.
- the secured tubes 146 can be fabricated by injection molding, extruding, ultrasonic welding, adhesive bonding, or by mechanically securing a covering over the tensile member 84 at defined locations.
- the secured tubes 146 can comprise a tubular, elliptical, rectangular, or other cross-sectional geometry.
- the secured tubes 146 can consist of materials such as expanded PTFE, silicone, cellulose acetate, regenerated cellulose, polyester, polypropylene, nylon-based materials, urethane or its derivatives, biological tissues (e.g., vessels, collagen based tissue structures, etc.), metals, alloys, other material capable of distributing stress over a length of the tensile member, or a composite of such materials.
- the movable 148 stress distributing tubes can be fabricated with the same processes, parameters, and materials as the secured 146 tubes described above provided the tensile member 84 can be pulled through the movable 148 stress distributing tubes. After placing the free ends of the tensile member 84 through myocardial tissue and pulling the free ends beyond the tissue surface, the movable ( 148 ) stress distributing tubes can be advanced over the tensile member 84 and positioned into the myocardial tissue. Once the stress distributing tubes are positioned, the tensile member can be tied into a knot 102 to compress the tissue region throughout the defined 3-dimensional region.
- the movable 146 stress distributing tubes can also comprise additional features such as flared proximal ends to abut the tissue surface to ensure hemostasis at the insertion and/or exit sites, and internal gaskets also to ensure hemostasis once a tensile member is advanced through a tube.
- the secured 146 and movable 148 stress distributing tubes prevent excess reduction or compression in the myocardial wall thickness upon application of tension to the tensioning structure.
- the three-dimensional cinching tensioning structure is capable of compressing the region of myocardium along the tissue surface to reverse the remodeling effect and support the tissue region without applying excess force along the plane defined by the thickness of myocardium.
- the three-dimensional, cinching, tensioning structures described above also exhibit required features to ensure the appropriate amount of compression against the tissue region is applied without tearing or damaging the tissue.
- a simple suture defines a highly localized stress concentration; especially at the insertion and exit puncture sites capable of cutting and severely traumatizing the tissue.
- a simple suture does not regulate the amount of compression applied along each of the three planes defined by the three-dimensional, cinching, tensioning structures; as such the myocardial wall thickness can be dramatically and undesirably reduced upon tightening without applying the desired compressive forces.
- FIGS. 37A to 37 C show the steps of placing a tensioning structure 4 , such as shown in FIGS. 36E to 36 H, through myocardium using the delivery system shown in FIGS. 36A to 36 D.
- Each free end of the tensile member is placed through a holder 64 of a puncturing device and the puncturing devices are compressed inside the deployment sheath.
- the two puncturing devices are placed in contact with the epicardial surface as shown in FIG. 37A (or alternatively can be placed into contact with the endocardial 70 surface for catheter-based or open surgical procedures).
- the puncturing devices are designed to penetrate the epicardium with sharpened or beveled tips 66 at spaced apart intervals.
- the tensile member 84 Prior to inserting the puncturing devices, the tensile member 84 can be placed through a pledget 118 or other atraumatic surface (e.g., an ePTFE patch, polyester patch, other synthetic patch, a piece of pericardium, muscle or other tissue) to add additional support at the anchor and provide additional strain relief to the underlying tissue once the tensile member is tightened, not shown.
- atraumatic surface e.g., an ePTFE patch, polyester patch, other synthetic patch, a piece of pericardium, muscle or other tissue
- the puncturing devices 62 are advanced through the deployment sheath 60 at which time they expand toward their preformed configuration channeling through myocardium to define a space for the tensile member to pass.
- the puncturing devices 62 can pass the tensile member 84 from the epicardial surface through the myocardium, past the endocardium, along the endocardium, and back to the epicardium. Once the puncturing devices have advanced the ends of the tensile member through the heart wall and back past the epicardium, the ends of the tensile member are removed from the holder and the puncturing device is subsequently removed from the heart. The free ends of the tensile member are then tied together thereby tightening and compressing a region of the heart wall. Again, prior to tightening the free ends of the tensile member, they can also be inserted through pledgets 118 or other atraumatic structure to provide additional support and strain relief at the tissue puncture sites. FIG.
- FIG. 37C shows a heart with sections cut-out and a tensioning structure 4 placed through the myocardium.
- the solid line demarcates the tensioning structure on the surface of the heart wall or along the cut-out section of the heart wall and the dotted line demarcates the tensioning structure section positioned through a spaced away section of myocardium.
- the tensioning structure passes through the myocardium along two spaced apart lines thereby producing a 3-dimensional cinching mechanism capable of tightening the heart wall in three planes, (a) along the insertion line through the myocardium, (b) between the insertion points defined by the spacing between insertion points through the epicardial 68 surface and into the myocardium and between the exit points the tensioning structure traverses prior to tightening into a knot, and (c) along the myocardial wall thickness.
- the ratio between these tension parameters (i.e., a, b, and c above), in terms of the length of the insertion line and the spacing respectively, the stress distribution ratios defined by the secured 146 and movable 148 stress distributing tubes, and the magnitude of the tightening force applied to the tensioning structure defines the applied load to the heart tissue.
- This applied tensile load thereby also defines the degree of tightening of the heart wall in the axial (from the annulus to the apex), lateral, and vertical directions respectively and can be adjusted to custom tailor the reduction in volume of the infarcted/ischemic zone.
- the tension can be adjusted as required to alter the wall motion of this zone to better match that of adjacent myocardium.
- these tensioning structures can be oriented at other angles relative to the heart thereby defining different tensioning planes, and the tensioning planes do not have to extend perpendicular to one another.
- the tensile members 84 , and secured 146 and movable 148 stress distributing tubes of tensioning structure embodiments deployed into the 3-dimensional, cinching pattern, as shown in FIGS. 36E to 36 H, 37 A to 37 C and described above, can consist of expanded PTFE, polypropylene, urethane derivatives, silicone, nylon, polyester, biological materials (e.g., pericardial tissue formed into strips, vascular tissue such as saphenous veins maintained in tubular form or cut into strips, submucosal tissue formed into strips, or other collagen or elastin based tissue structure), genetically engineered tissue formed into strips, metals (e.g., titanium), alloys (e.g., stainless steel, nickel titanium, etc.), polymers, or other material formed into a line, strip, tube, rod, bar, or other geometry.
- biological materials e.g., pericardial tissue formed into strips, vascular tissue such as saphenous veins maintained in tubular form or cut into strips, submucos
- FIGS. 38A to 38 C show the deployment of a tensioning structure through myocardium utilizing an alternative deployment system of the invention, which is shown in FIGS. 43A to 43 D.
- a single tensile member 84 is shown deployed through the myocardium.
- anchors can be placed over the free ends of the tensile member 84 to secure both ends of said member to the tissue surface.
- the opposite ends of the tensile member can then be tied producing an axially oriented tightening of the tensioning structure; or one free end of the tensile member can be subsequently inserted through myocardium at a spaced apart location to produce a three-dimensional, cinching effect; or a second tensile member can be inserted at a spaced apart location with the deployment system and the free ends of the tensile member pair can be tied together in some pattern to tighten the tensioning structure and reinforce the infarcted/ischemic zone.
- secured 146 and movable 148 stress distributing tubes can be oriented to define the ratios of compression, regulate the amount of myocardial wall thickness reduction/compression, and distribute the stress at the insertion and exit sites of the tensile member.
- this delivery system embodiment incorporates two sheaths defining different curves and a puncturing device 62 .
- the outer sheath 104 incorporates a beveled tip to define the initial penetration through the tissue surface.
- the middle sheath 106 incorporates a curved region and a beveled tip to tunnel through the myocardium (either partially or completely through the other tissue surface). The curved region of the middle sheath 106 straightens as the middle sheath is retracted into the outer sheath in a coaxial arrangement.
- the inner puncturing device 62 incorporates a curve to orient the distal end of the puncturing device back out of the myocardium and past the initial tissue surface at a defined distance from the initial penetration or insertion site defined by the curve of the middle sheath and the curve of the puncturing device as shown in FIG. 43D .
- the puncturing device 62 also incorporates a needle tip 66 (e.g., beveled tip, cutting tip, pointed tip, diamond tip, or other configuration) and a holder 64 .
- the holder 64 in this configuration is a slotted region from one side that includes a small inward protrusion to prevent the tensile member from migrating out of the slotted region once positioned.
- the tensile member 84 is positioned into the holder by advancing a side of the tensile member through the slot until it is advanced past the protrusion. Removal of the tensile member can be done manually by pulling the member laterally from the slot or axially past the protrusion with forceps, needle drivers, or other surgical instrument.
- two inner puncturing devices can alternatively be utilized with a larger middle sheath (single or dual-lumen) and a larger outer sheath to simultaneously deploy two ends of a single tensile member through tissue at spaced apart intervals or two individual tensile members through tissue at spaced apart intervals.
- three or more inner puncturing devices can be utilized with appropriately configured middle and outer sheaths to deploy more than two individual tensile members through tissue simultaneously.
- FIG. 42 illustrates an alternative, puncturing device that incorporates the holder 64 as a separate component inserted through a hole or slot in the body of the puncturing device 62 just proximal to the needle tip 66 .
- the holder 64 component of this embodiment consists of a wire wound into a shepherd's hook type or other similar geometry that can be fed through the hole or slot of the puncturing device such that it enables insertion or retraction of tensioning structures through tissue.
- FIG. 39A shows the placement of a three-dimensional, cinching, tensioning structure placed through myocardium of the left ventricle, extending from the epicardium, through myocardium, past the endocardium and back to the epicardium at a distance from the initial puncture site. It also depicts the placement of a three-dimensional, cinching pattern using tensioning structures through the myocardium of the right ventricle and extending along the endocardium of the right ventricle for a significant distance.
- the tensioning structures can be deployed with the systems described above to reinforce the left or right ventricle along an infarcted/ischemic zone or other weak or remodeling zones.
- FIGS. 39B and 40E show three-dimensional cinching, tensioning structures placed along the mitral valve annulus 108 with one section of the tensile member (or one discrete tensile member as discussed above) placed on the left atrial side 74 and one section (or another discrete tensile member) placed on the left ventricular side.
- FIG. 40E also shows a three-dimensional, cinching, tensioning structure similarly placed along the tricuspid annulus. Once tied, the tensioning structure can cinch and tighten the mitral (or tricuspid) annulus similar to the tensioning structure embodiments discussed previously.
- FIGS. 40A to 40 D show representative three-dimensional, cinching, tensioning structure patterns capable of reinforcing infarcted and ischemic zones of the heart.
- Any pattern of tensioning structures can be capable of providing the desired recovery or reverse remodeling response where the tensioning structures extend between border regions of the infarcted/ischemic zones passing through the zone or extending from inside the infarcted/ischemic zone to just beyond the border regions.
- an individual tensioning structure can pass through multiple infarcted/ischemic zones to reinforce a larger region of ventricular tissue.
- 40F shows a group of three-dimensional, cinching, tensioning structures extending around an infarcted/ischemic zone and passing from a border zone into or beyond the infarcted/ischemic zone.
- the free ends of this flower-shaped pattern of three-dimensional, cinching, tensioning structures can be tied together permanently or secured to a mechanism capable of twisting the knotted regions or otherwise manipulating the free ends to adjust or tighten the tensioning structures intraoperatively, during a follow-up procedure, or remotely post procedure. Again, these adjustments can facilitate chronic maintenance of positive hemodynamic conditions.
- FIG. 41A shows a three-dimensional, cinching, tensioning structure incorporating two insertion and exit points along the axial plane.
- secured 146 and movable 148 stress distributing tubes can be oriented along the tensile member, especially proximate to the various insertion and exit sites.
- the tightening force is distributed at more than two locations (i.e.,the insertion and knotted sites) thereby ensuring that a long, tightening structure will be capable of reinforcing tissue midway between the ends of the three-dimensional, cinching, tensioning structure.
- more than two, inline loops can be utilized for the three-dimensional cinching tensioning structures.
- FIG. 41B a three-dimensional, cinching, tensioning structure oriented in a dual-loop shaped configuration surrounded by a similar tensioning structure oriented in a shield-shaped configuration.
- the tensile member passes through and above the tissue 112 at the center of the configuration.
- FIG. 41C shows an alternative tensioning structure pattern that spirals around the infarcted/ischemic zone from the border region to the center of the zone.
- the free ends of this structure can be tightened to compress the zone inward towards the middle.
- the spiral pattern can be also be adjusted to take into account the different degrees of motion laterally versus apically by altering the length versus width ratio of the spiral pattern, the spacing between entry and exit points, and the spacing between each concentric ring of the pattern.
- 41E illustrates the outwardly expanded extensions placed against the endocardial (or epicardial) surface to lock the attached tensile member 84 to the heart. It is also noted that these tensioning structures can also comprise secured 146 and movable 148 stress distributing tubes as described above.
- FIGS. 41F and 41G show a perspective view of a heart with a three-dimensional, cinching, myocardial tensioning structure embodiment incorporating an automatic, knot-locking anchor mechanism to variably tighten the free ends of the tensile member 84 .
- FIG. 41F shows the tensioning structure 4 with the knot anchor 150 engaging the tensile members 84 , but not completely tightened.
- FIG. 41G shows the myocardial tensioning structure 4 with the knot anchor 150 tightened over the free ends of the tensile member 84 .
- FIG. 41H shows a close-up, cross-sectional view of the knot anchor 150 in FIGS. 41F and 41G .
- FIG. 41I also depicts a close-up, cross-sectional view of an alternative, knot anchor embodiment with one end of the tensile member 84 attached and the other end movable relative to the ratcheting extension or jaw 152 .
- the knot anchor also incorporates a ratchet mechanism jaw 152 that enables the tensile member 84 to pass in one direction through a sidewall exit hole 172 , but prevents migration in the opposite direction allowing it to act as a locking mechanism 168 .
- These knot anchor embodiments permit remote tightening and adjustment of the tensioning structure 4 once positioned to enable gradual tightening over a period of time to maximize and maintain the reverse remodeling effects.
- FIGS. 44A and 44B show a tensioning structure embodiment that incorporates a tensile member secured to a self-expanding (or plastically deformable) anchor as described above in the Intravascular Conduit Tensioning Structures and Cardiac Valve Annulus Tensioning Structures sections of this specification.
- Both anchor ends of a tensioning structure are compressed into a low profile within the lumen of a delivery sheath, similar to FIG. 43A , incorporating a beveled tip to puncture through tissue.
- a single sheath can be used to insert both anchors of the tensioning structure into or through myocardium, or each anchor can be compressed into individual sheaths.
- FIG. 44A and 44B show a tensioning structure embodiment that incorporates a tensile member secured to a self-expanding (or plastically deformable) anchor as described above in the Intravascular Conduit Tensioning Structures and Cardiac Valve Annulus Tensioning Structures sections of this specification.
- 44A shows a heart with sections cut away containing a deployed anchor extending through the myocardium and incorporating radial extensions engaging the endocardial surface.
- a tensioning member is shown attached to the deployed anchor formation with the opposite end of the same tensioning member shown secured to an anchor compressed inside a sheath for deployment through the myocardium and into the left ventricular cavity.
- a stylet is used to advance the anchor beyond the confines of the constraining sheath where the anchor is allowed to expand into its preformed or radially expanded configuration. Then, the anchor can be retracted into engagement with the endocardial surface as shown in FIG. 44B with application of tension to the tensile member.
- the tensile member can be further tightened by creating a knot or by twisting to increase the applied force as required.
- the anchors can be placed into the myocardium such that the extensions lock to myocardial tissue without extending beyond the endocardial surface.
- the sheath used to deploy the anchors of the tensioning structure can incorporate a slot for the tensioning member to pass thereby preventing slack along the tensile member that is tightened by forming a knot or other tying mechanism. It is therefore noted that individual tensioning structures containing an anchor only at one end while the opposite end remains free can be deployed and secured using the deployment system previously described and the free ends can be tied together to tighten the tensioning structures to produce the desired volume reduction, reinforcement or other compressive response.
- FIG. 44C shows additional features to the tensioning structure described above where pledgets 118 or other similar atraumatic interfaces mentioned elsewhere in this specification are positioned at each insertion point of the anchor through the epicardial surface to provide strain relief and to prevent abrasion or other unwanted effect of tightening of the tensile member against tissue.
- a pledget 118 or other atraumatic interface can also be placed under the knot used to tighten the tensioning structure.
- the tensioning structures can comprise secured 146 and movable 148 stress distributing tubes, as described above, at the insertion or exit sites, along the myocardial wall, or elsewhere along the tensile member(s).
- the tensioning structures and incorporated anchors can alternatively be inserted from the endocardial surface into myocardium or through myocardium such that the anchors contact the epicardial surface during surgical or catheter-based approaches, as shown in FIGS. 45A and 45B .
- One or more sheaths can be used to deploy the two anchors and the tensile member into the heart.
- the base 114 of such endocardial anchors can be configured with marker bands 36 in this approach.
- the anchor is inserted within the myocardium or further manipulated through the myocardium, past the epicardial surface, and into the pericardial space where it expands towards its preformed configuration and is engaged against the epicardial surface, as shown in FIG. 45A .
- FIGS. 45F to 45 H show this anchor embodiment expanding towards its preformed enlarged, radially expanded configuration.
- a balloon or other expansion mechanism can be used to plastically deform the anchor into an enlarged orientation.
- the engagement pins 130 are biased outward to contact myocardium or the epicardial surface (or endocardial surface for surgical approaches described above) and prevent retraction of the anchor once positioned.
- the tensile member 84 is secured to the base 114 of the anchor preferably such that maximum outer diameter of the tensile member 84 is greater than the cross-sectional diameter of the base 114 of the anchor to ensure hemostasis through the channel created through the myocardium once the anchor is inserted and secured in place.
- the tensile member 84 covers the entire cross-section of the base 114 of the anchor 32 .
- the tensile member can be secured to one side of the base and have a diameter smaller than the outside diameter of the base 114 . It should be noted that the deployment system and anchor embodiments shown in FIGS. 45C to 45 H are directly applicable to the surgical process described for FIGS. 44A to 44 C above.
- 45K and 45L show a perspective view and a side view of the anchor 32 with a tensile member 84 attached to the interior surface of the anchor from the distal end 132 to the base 114 .
- the tensile member 84 can alternatively be attached beyond the exterior surface of the base 114 .
- anchor embodiments shown in FIGS. 45F to 45 L can be utilized as an anchor that engages the coronary sinus orifice when inserting the tensioning structure intravascularly within the coronary sinus for tightening and reinforcing the valve annulus as described in the Cardiac Valve Annulus Tensioning Structures section above.
- These anchor embodiments can also be inserted through valve leaflets to reposition the valves upon applying tension via the tensioning structure, as described in the Chordae Tendineae and Valve Leaflet Tensioning Structures section below.
- a single sheath incorporating two stylets having different profiles to accommodate different diameter anchors or anchors incorporating features enabling sequential deployment of the first anchor prior to actuation of the second anchor can be used to deploy the tensioning structure during catheter-based procedures. Once the first anchor is positioned and engaged into tissue, the second can be positioned and deployed. The final result of such an approach is illustrated in FIG. 45B .
- FIGS. 46A to 46 M show an alternative, integrated tensioning structure embodiment where the tensile member 84 incorporates features to enable anchoring and a preformed geometry having sufficient column strength to be directed through myocardium without the need for the deployment sheath to puncture tissue to insert the tensile member and/or anchor.
- the tensioning structure is constrained into a low profile inside a blunt tip deployment sheath.
- This tensioning structure embodiment is preferably fabricated from a superelastic alloy (e.g., nickel titanium), other alloy (e.g., stainless steel), or metal (e.g., titanium) incorporating an elastic component and a preformed geometry.
- a superelastic alloy e.g., nickel titanium
- other alloy e.g., stainless steel
- metal e.g., titanium
- the tensioning structure itself is used to puncture the epicardial surface (or endocardial surface for catheter-based approaches) and channel through the myocardium. As the tensioning structure is further advanced beyond the confines of the blunt deployment sheath, as shown in FIG. 46G , the tensioning structure returns towards it preformed or expanded shape directing the free end of the tensioning structure back up towards and past the epicardial (or endocardial) surface.
- This tensioning structure embodiment consists of a stiff tensile member formed into a “U” shape with sharp free ends 120 to penetrate tissue.
- Each of the free ends 120 is inserted through the tissue surface at spaced apart intervals such that once positioned the looped or flat end of the “U” shape can be used to anchor the tensioning structure at one end.
- secured 146 or movable 148 stress distributing tubes can be used as required at this end to dampen the trauma and regulate application of the compressive forces by the tensioning structure against the tissue surface.
- a separate locking anchor 124 can be secured to the free ends of the tensioning structure into notches 122 or other mating features in the tensioning structure 4 to define and maintain the applied tension and to prevent migration.
- the anchor can consist of a tube, bar, or sheet containing openings and a ratchet mechanism that allows the sharp ends of the tensioning structure to enter while preventing separation once placed, as shown in FIG. 46K .
- FIGS. 46L and 46M show an illustrated placement of this tensioning structure embodiment after deployment and after locking with the anchor component, respectively.
- this clip-like tensioning structure embodiment can traverse in any direction around the infarcted/ischemic zone and multiple clip-like tensioning structures can be inserted and secured throughout the infarcted/ischemic zones to custom tailor the reinforcement profile to the patients needs.
- FIGS. 46N to 46 P show additional delivery system features for deploying these integrated 3-dimensional, cinching, tensioning structures.
- FIG. 46N shows the deployment sheath with a flared, distal end 134 to provide strain relief during puncture
- FIGS. 46O and 46P show expandable/compressible extensions associated with the deployment sheath to enable low profile entry into the body, to stabilize and provide a surface to leverage the deployment sheath during puncture preventing inadvertent insertion of the sheath through the heart's surface.
- An outer constraining tube 138 is used to compress the extensions 136 during deployment through ports into the chest cavity or other less invasive access.
- the extensions can be fabricated rigid, especially for invasive surgical approaches such as a median sternotomy.
- FIGS. 46Q to 46 Y show alternative integrated, 3-dimensional, cinching, tensioning structures 4 of the invention.
- These tensioning structures 4 incorporate spring mechanisms at the loop anchors 96 and anchor lock springs 144 to further custom tailor the cinching forces applied by the tensioning structure to the heart tissue.
- These spring mechanisms can comprise a helix, a sinusoid, open cells, or other expandable and compressible mechanisms.
- anchor lock holes 142 can be incorporated in the distal end of the tensile member 84 to enable locking the anchor lock springs 144 to the tensile member 84 to define the attached tensioning structure 4 .
- the three-dimensional, cinching, tensioning structure in FIGS. 46S to 46 Y further incorporates a straightening lumen 140 through which a stylet can be inserted to orient the tensile member 84 for deployment into or through myocardium.
- a stylet As the stylet (not shown) is advanced through the straightening lumen 140 , the tensile member straightens for insertion into or through myocardium.
- the tensile member reverts back towards its preformed, curved shape channeling through tissue and defining the deployed configuration. Once deployed, the stylet is removed leaving the tensile member to be locked with the anchor spring 144 .
- the tensioning structures of the invention by also be used to apply tension to papillary muscles and/or chordae tendineae to reposition the valve leaflets to reduce/eliminate regurgitation, to limit the motion of the leaflets to improve/restore the function of cardiac valves; and to directly reposition the valve leaflets to prevent prolapse or other abnormalities of the leaflets and to prevent associated deficiencies.
- FIGS. 47A to 47 D show a tensioning structure embodiment and delivery system used to place the tensioning structure from the epicardium through the myocardium, around one or more chordae tendineae or through a papillary muscle, and back through the myocardium where the tensioning structure is anchored such that it applies tension to these sub-valvular structures to reorient the valve leaflets and restrict valve prolapse.
- FIGS. 47A to 47 C show the three-component delivery system from FIGS. 43A to 43 D passing one or more tensioning structures through or around the chordae tendineae 110 , or through or around a papillary muscle.
- the delivery system locates the free ends of the tensioning structures through myocardium and external to the endocardium where they can be tied to tighten the tensioning structures.
- the outer sheath is inserted through the heart wall.
- the outer sheath can incorporate a beveled tip as shown in FIG. 43A or can be inserted over a trocar, needle, or other penetrating mechanism.
- the middle sheath is then advanced through the outer sheath as shown in FIG. 47B .
- the puncturing device is inserted through the middle sheath and is used to pass the tensioning structure 4 through the middle sheath and back through the endocardium, through the myocardium and past the epicardium where it can be removed from the holder with forceps or other similar instrument. Then as shown in FIG. 47D , the deployment system is removed and the tensioning structure is tightened. The degree of tightening can be guided or adjusted based on Transesophageal Echocardiography, Intracardiac Echocardiography, MRI, Fluoroscopy, CT, or other imaging or visualization modality capable of determining the apposition and movement of the valve leaflets.
- FIGS. 48A and 48B show an alternative tensioning structure and associated delivery system used to engage a chordae tendineae or papillary muscle with one end while the opposite end produces an anchor that is capable of tightening to apply tension to the chordae tendineae or papillary muscles 128 . As shown in FIGS.
- the tensioning structures can alternatively be inserted through the valve leaflets as opposed to around or through the papillary muscle or chordae tendineae to directly reposition the valve leaflets by tightening the tensioning structures from the epicardial surface of the heart.
- a grasping instrument containing a lumen providing passage for the puncturing device can be used to temporarily engage the valve leaflet and provide a path to advance the tensioning structure past the epicardial surface, through the myocardium, up to and through the valve leaflet. Then the anchor is deployed (by balloon expansion or release of a self-expanding anchor) against the valve leaflet thereby attaching the tensile member 84 .
- proximal end of the tensile member is then retracted past the epicardial surface and the desired amount of tension to reposition or stabilize the valve leaflet is applied based upon real-time assessment/visualization of hemodynamics and anatomic motion.
- the proximal end of the tensile member 84 is anchored to the epicardial surface at a suitable location.
- the delivery system used to engage the valve leaflet can provide a mechanism to grasp the tensile member 84 after insertion of the tensile member through the valve leaflet.
- Such a mechanism would enable retraction back past the myocardium and epicardium so that the opposite free ends of the tensile member 84 can be tied, tightened and used to manipulate the position of the valve leaflets, thereby defining the tensioning structure.
- the leaflets may be directly manipulated and repositioned using the mechanism in FIGS. 51A and 51B .
- This mechanism facilitates grasping and then locking onto the leaflet tissue by engaging the jaw 152 with an anchor cincher tube 150 .
- the mechanism could be attached to a tensile member and anchor to facilitate locating and securing the structure at the desired position to urge valve competency.
- the embodiments of the entire invention described herein can be fabricated from various biological, metallic, and polymeric materials.
- those components are preferably fabricated from a superelastic, shape memory material like nitinol (nickel titanium alloy).
- nitinol nickel titanium alloy
- These types of materials elastically deform upon exposure to an external force and return to their preformed shape upon reduction or removal of the external force. This elasticity property renders the material as ideal for deployment with vascular conduit target about eccentric, three-dimensional tortuous geometries with limited concern toward fatigue failure and difficulty in placement.
- Superelastic shape memory alloys also enable straining of the material numerous times without plastic deformation. The repetitive strain capability facilitates a limited systolic stretch to enable adequate cardiac output while limiting or restricting the possibility of over stretch and continuation of the cyclic damage.
- Various components of the tensioning structures can be fabricated from shape memory alloys (e.g., nickel titanium) demonstrating stress-induced martensite at ambient temperature.
- shape memory alloys e.g., nickel titanium
- Other shape memory alloys can be used and the superelastic material can alternatively exhibit austenite properties at ambient temperature.
- the composition of the shape memory alloy is preferably chosen to produce the finish and start martensite transformation temperatures (Mf and Ms) and the start and finish austenite transformation temperatures (As and Af) depending on the desired material response.
- the material composition is chosen such that the maximum temperature that the material exhibits stress-induced martensite properties (Md) is greater than Af and the range of temperatures between Af and Md covers the range of ambient temperatures to which the support members are exposed.
- the material composition is chosen such that both Af and Md are less than the range of temperatures to which the supports are exposed.
- Af and Md can be chosen at any temperatures provided the shape memory alloy exhibits superelastic properties throughout the temperature range to which they are exposed.
- Nickel titanium having an atomic ratio of 51.2% Ni to 48.8% Ti exhibits an Af of approximately ⁇ 20° C.
- nickel titanium having an atomic ratio of 50% Ni to 50% Ti exhibits an Af of approximately 100° C.
- the tensioning structures are expected to be of limited thrombogenicity and with percutaneous deployment especially in venous structures of the heart, the risk of infarct, adverse cerebral embolic events and other similar ischemic events/injury is severely limited if not avoided. Also, administration of commonly used anti-clotting and anti-platelet pharmacological agents is generally restricted to the implant procedure and not required in an ongoing basis.
- the tensioning structures can be fabricated from at least one rod, wire, suture, strand, strip, band, bar, tube, sheet, ribbon or other such raw material having the desired pattern, cross sectional profile, dimensions, or a combination of cross-sections.
- These raw materials can be formed from various standard means including but not limited to: extrusion, injection molding, press-forging, rotary forging, bar rolling, sheet rolling, cold drawing, cold rolling, using multiple cold working and annealing steps, or casting.
- superelastic materials or other alloys as the tensioning structures, they can be cut into the desired pattern and thermally formed into the desired three-dimensional geometric form.
- tensioning structure components can also be further modified via centerless grinding means to enable tensioning structures that are tapered (i.e.,have a cross-sectional diameter on the proximal end of the structure that progressively ramps down to a smaller cross-section on the opposite or distal end).
- Tensioning structure components of this type of geometry are ideally suited for placement in the vascular conduits since said anatomical conduits tend to taper in a similar fashion from the proximal ostia down to distal locations.
- the tensioning structure components can be fabricated from a multitude of these individually processed or unprocessed components (rods, wires, bands, bars, tubes, sheets, ribbons, etc.) and joined together using various means including but not limited to the following: laser welding, adhesive bonding, soldering, spot welding, mechanical crimping, swaging and other attachment means to produce composite tensioning structures.
- the raw material can have an oval, circular, rectangular, square, trapezoidal, or other cross-sectional geometry capable of being cut into the desired pattern.
- the tensioning structure components are formed into the desired shape, heated, for example, between 300° C. and 600° C., and allowed to cool in the preformed geometry to set the shape of the support members.
- the raw material When fabricating superelastic tensioning structure components from flat sheets of raw material, the raw material can be configured with at least one width, W, and at least one wall thickness, T, throughout the raw material. As such, the raw sheet material can have a consistent wall thickness, a tapered thickness, or sections of varying thickness.
- the raw material is then cut into the desired pattern, and thermally shaped into the desired three-dimensional geometry.
- Opposite ends or intersections of thermally formed tensioning structure components can be secured by using shrink tubing, applying adhesives, welding, soldering, mechanically engaging, utilizing another bonding means or a combination of these bonding methods.
- Opposite ends of the thermally formed tensioning structure components can alternatively be free-floating to permit increased flexibility.
- the supports can be electropolished, tumbled, sand blasted, chemically etched, ground, or otherwise treated to remove any edges and/or produce a smooth surface.
- the previous discussions provide description of minimally invasive and percutaneous tensioning structures and delivery devices used to treat degenerative heart disease in patients suffering any stage of congestive heart failure.
- the described inventions provide a methods and devices to provide restriction of continued enlargement of the heart, potentially progressively reduce heart size via reverse remodeling (i.e.,application of compressive force during both systole and diastole) and finally decrease valvular regurgitation associated with said enlargement.
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Abstract
Described are devices and methods for treating degenerative, congestive heart disease and related valvular dysfunction. Percutaneous and minimally invasive surgical tensioning structures offer devices that mitigate changes in the ventricular structure (i.e., remodeling) and deterioration of global left ventricular performance related to tissue damage precipitating from ischemia, acute myocardial infarction (AMI) or other abnormalities. These tensioning structures can be implanted within various major coronary blood-carrying conduit structures (arteries, veins and branching vessels), into or through myocardium, or into engagement with other anatomic structures that impact cardiac output to provide tensile support to the heart muscle wall which resists diastolic filling pressure while simultaneously providing a compressive force to the muscle wall to limit, compensate or provide therapeutic treatment for congestive heart failure and/or to reverse the remodeling that produces an enlarged heart.
Description
- This application claims the benefit of Provisional Application Ser. No. 60/329,694 entitled “Percutaneous Cardiac Support Structures and Deployment Means” filed Oct. 16, 2001 and Provisional Application Ser. No. 60/368,918 entitled “Percutaneous Vascular Tensioning Devices and Methods” filed Mar. 29, 2002, each of which is incorporated herein by reference.
- The present invention relates generally to minimally invasive medical devices for treating or preventing congestive heart failure and related or concomitant valvular dysfunction. More specifically, the invention relates to tensioning structures and related deployment devices to mitigate changes in the ventricular structure and geometry and deterioration of global left and right ventricular performance related to tissue damage from myocardial ischemia, acute myocardial infarction (AMI), valve related disease or dysfunction, or other instigators of deterioration of cardiac function.
- Congestive heart failure (CHF) is a progressive and lethal disease if left untreated. CHF syndrome often evolves as a continuum of clinical adaptations, from the subtle loss of normal function to the presence of symptoms refractory to medical therapy. While the exact etiology of the syndrome that causes heart failure is not fully understood, the primary cause of CHF is left ventricular dysfunction (i.e., the inability of the heart to properly and adequately fill or empty blood from the left ventricle with adequate efficiency to meet the metabolic needs of the body).
- In addition, non-cardiac factors can also be activated due the overall degenerative cycle that ensues. These include neuro-hormonal stimulation, endothelial dysfunction, vasoconstriction, and renal sodium retention-all of which can cause dyspnea, fatigue and edema rendering patients unable to perform the simplest everyday tasks. These types of non-cardiac factors are secondary to the negative, functional adaptations of the ventricles, cardiac valves and/or load conditions applied to or resisted by these structures. With existing pharmacological, surgical and device-based therapies symptoms can be alleviated, but the quality of a patient's life remains significantly impaired. Further morbidity and mortality associated with the disease is exceptionally high.
- Ischemic heart disease is currently the leading cause of CHF in the western world, accounting for greater than 70% of cases worldwide. In these cases, CHF can precipitate from ischemic conditions or from muscle damage (i.e., due to obstruction of a coronary artery) which can weaken the heart muscle, thereby initiating a process known as remodeling in which changes in cardiac anatomy and physiology include ventricular dilatation, regional wall motion abnormalities, decreases in the left ventricular ejection fraction and impairment of other critical parameters of ventricular function. Such left ventricular dysfunction may be further aggravated by hypertension and valvular disease in which a chronic volume or pressure overload can alter the structure and function of the ventricle. Decreases in systolic contraction can lead to cardiomyopathy, which further exacerbates the localized, ischemia damaged tissue or AMI insult into a global impairment, thereby leading to episodes of arrhythmia, progressive pump failure and death.
- Ischemia-damaged and/or infarct damaged heart muscle tissue results in progressive softening or degeneration of cardiac tissue. These ischemic and infarcted zones of the heart muscle wall have limited, if not complete loss of tissue contractile functionality and overall physical integrity and present an analogous situation to those presented by vascular aneurysms.
- CHF is usually associated with a progressive enlargement of the heart as it increases contractility and heart rate in a compensatory response to the decreasing cardiac output. With this enlargement, the heart's burden is increased to pump more blood with each pump cycle. A phenomenon known as myocardial stretch is implicated in a degenerative cycle/ feedback loop that causes areas of compromised heart muscle tissue to bulge further outward. When the bulging is related to AMI, this behavior is characterized as infarct expansion. With this bulging, the heart's natural contraction mechanism is dissipated and attenuated, resulting in a marked and progressing decrease in cardiac output.
- Normal cardiac valve closure (especially that of the mitral valve) is dependent upon the integrity of the myocardium, as well as that of the valve apparatus itself. The normal mitral valve is a complex structure consisting of leaflets, an annulus, chordae tendineae, and papillary muscles. Any damage or impairment in function of any of these key components can render the valve structure incompetent. Impairment of valve function, due to independent factors (i.e., a concomitant valve pathology) or dependent factors (i.e.,valve dilation related to dilated cardiomyopathy), can result in valvular insufficiency further exacerbating the degenerative CHF cycle.
- The major objectives of heart failure therapy are to decrease symptoms and prolong life. The American Heart Association guidelines suggest that optimal treatment objectives include means to increase survival and exercise capacity, and to improve quality of life, while decreasing symptoms, morbidity and the continued progression of the cardiac degeneration. Various pharmacological and surgical methods have been applied both with palliative and therapeutic outcome goals. However, there still remains no definitive cure for CHF.
- Modern pharmacological approaches such as diuretics, vasodilators, and digoxin dramatically lessen CHF symptoms and prolong life by mitigating the non-cardiac factors implicated in the syndrome. Furosemide (more commonly known as Lasix™) is also a valuable diuretic drug which eliminates excess water and salt from the body by altering kidney function and thereby increasing urine output, thus relieving circulatory congestion and the accompanying pulmonary and peripheral edema.
- Vasodilators, like angiotensin-converting-enzyme (ACE) inhibitors have become cornerstones in treatment of heart failure. These kinds of vasodilators relax both arterial and venous smooth muscle, thereby reducing the resistance to left ventricular ejection. In patients with enlarged ventricles, the drug increases stroke volume with a reduction in ventricular filling pressure. Administering digoxin has also been found to be positively inotropic (i.e., strengthening to the heart's contractile capability).
- On the surgical front, cardiomyoplasty is a recently developed treatment of CHF. In such a procedure, the latissimus dorsi muscle is removed from the patient's shoulder, wrapped around the heart and chronically paced in synchrony with ventricular systole in an effort to assist the heart to pump during systole. The procedure is known to provide some symptomatic improvement, but is controversial with regard to its ability to enable active improvement of cardiac performance. It is hypothesized that the symptomatic improvement is primarily generated by passive constraint and mitigation of the degenerative, remodeling process. In spite of the positive outcome on relieving some of the symptoms, the procedure is highly invasive, requiring access to the heart via a sternotomy, expensive, complex and of unknown durability (due to the muscle wrap blood flow requirements and fibrosis issues).
- Another surgical procedure of interest has been developed by R. Bautista, MD. In this procedure, the overall mass, volume and diameter of the heart are physically reduced by dissection and removal of left ventricular tissue. While innovative, the procedure is highly invasive, traumatic and costly. Further, the actual volume reduction results in a reduction in valve competence and elicits the associated regurgitation.
- Surgical treatment of valvular dysfunction includes a wide range of open procedure options ranging from mitral ring annuloplasty to complete valve replacement using mechanical or tissue-based valve prosthesis. While being generally successful and routine in surgical practice today, these procedures are also costly, highly invasive and are still have significant associated morbidity and mortality.
- More recently, mechanical assist devices which act as a bridge to transplant such as the left ventricular assist device (LVAD) or the total artificial heart (TAH) implant have become available. LVAD's are implantable, mechanical pumps that facilitate the flow of blood from the left ventricle into the aorta. The latest TAH technologies feature many improved design and material enhancements that increase their durability and reliability. Still, the use of such devices is limited by high costs and a lack of substantial, clinical evidence warranting their use.
- Other device-based options for CHF patients include approaches for reshaping, reinforcement and/or reduction of the heart's anatomical structure using polymeric and metallic bands, cuffs, jackets, balloon/balloon-like structures or socks to provide external stress relief to the heart and to reduce the propensity/capability of the cardiac tissue to distend or become continually stretched and progressively damaged with pump cycles. Examples of such devices are United States Patent No. 2002/0045799 and U.S. Pat. No. 5,702,343. In addition, devices are being studied that attempt to prevent the tissue remodeling using tethers and growth limiting struts or structures described in various patents (i.e., U.S. Pat. No. 6,406,420).
- Generally, all of these concepts support the cardiac muscle and restrict growth externally and globally via surgical placement about the epicardium and in some instances are positioned across the cardiac muscle tissue. As a result, these types of approaches require unnecessary positioning of the devices over healthy (non local, undamaged) areas or zones of the heart affecting the entire organ when the primary treatment is usually focused is on the left ventricle or the mitral valve annulus. Such non-localized treatment can elicit iatrogenic conditions such as undesired valvular dysfunction and/or constrictive physiology due to over restriction of the heart by such restraints.
- Recently, several-device based options have been introduced where implants are positioned by minimally invasive means in the coronary sinus in one configuration and then assume a post deployment configuration that constricts around the heart annulus to improve valve competence in dilated cardiomyopathy (see, United States Patent Application Publication No. 2002/016628.) While appealing, the clinical efficacy of this approach is unknown at this time.
- The ultimate treatment for people suffering end stage CHF is a heart transplant. Transplants represent a massive challenge with donor hearts generally in short supply and with the transplant surgery itself presenting a high risk, traumatic and costly procedure. In spite of this, transplants present a valuable, albeit limited, upside, increasing life expectancy of end stage congestive heart failure patient from less than one year up to a potential five years.
- In view of the above, it should be evident that there is currently no ideal treatment among the various surgical, pharmacological, and device-based approaches to treat the multiple cardiac and non-cardiac factors implicated with the syndrome of CHF. Accordingly, there is a clear, unmet clinical need for technology that is minimally invasive (especially, percutaneous) that can prevent, treat or reduce the structural remodeling to the heart and its sub-structures across the continuum of the CHF syndrome beginning acutely with the ischemia or ischemic infarct through the end stages where there is often left ventricular and valvular dysfunction refractory to conventional treatments.
- Still, patients suffering from CHF, who are unresponsive to medication, generally precluded to open surgical approaches and potentially awaiting transplant could derive massive and direct benefit from a minimally invasive device as provided by the present invention to limit further degeneration of their condition. In addition, implant embodiments of the present invention can also facilitate positive or reverse remodeling (i.e., provide a mild compressive force both during systole and diastole to improve cardiac output and efficiency).
- The present invention meets these needs with tensioning structures that can be utilized locally (e.g., left ventricular anterior wall only versus about the entire heart) to reduce wall stresses, reinforce the walls, and reduce/limit volume of the heart muscle as required using percutaneous, minimally invasive surgical (MIS), and open surgical means or a combination thereof. Devices according to the present invention may be used to facilitate operator controlled “tailoring” of localized treatment using various embodiments of the invention at various chosen target zones (i.e., left ventricle, mitral valve annulus, or sub-valvular apparati). Custom tailoring of each tensioning structure enables application of compression against specific regions of tissue in one, two or three dimensions relative to the heart's surface and patient specific adjustability of the amount of compression applied to the tissue to optimize the heart's overall hemodynamic performance.
- Tensioning structures according to the invention can be individually placed within or about the heart (intravascularly or extravascularly) working in concert to provide reinforcement against myocardial stretch (or infarct expansion) and additionally to facilitate contraction of tissue previously subject to such myocardial degeneration. In doing so, the contractile and expansion energies of the heart can be transferred to and across the weakened sections of the heart from the more viable sections of the heart muscle. Such devices provide localized dynamic support or reinforcement and are active throughout the cardiac cycle unlike previous device approaches that generally only reduce the stress in the heart wall during diastole. Diastolic compliance can also be regulated or controlled with structures according to the invention. Also, the tensioning structures facilitate and maintain a more efficient and perhaps optimal wall motion through the cardiac cycle thereby aiding in diastolic filling and systolic contraction at the tissue area that has been compromised by ischemia, infarct or other abnormalities. The tensioning structures are implanted in target heart regions using standard cardiovascular, interventional techniques using guiding catheters and introducing sheaths or less invasive surgical techniques involving port access or small incisions into the thoracic cavity to eliminate the need for more radical surgery (e.g., median sternotomy) to provide a potential, palliative or therapeutic response to the disease.
- Furthermore, the tensioning structures of the invention may provide a complete, comprehensive solution for treatment of congestive heart failure addressing deficiencies to the wall motion of the heart (e.g., akinesis, hypokinesis or dyskinesis), and/or valve insufficiencies. The present invention comprises such device-based technology as summarized above, that is further described below with associated methodology, including deployment, production, development and use of the same. Still further, as part of a system, kit or otherwise, the invention shown herein may be provided or used in connection with the invention described in U.S. Provisional Patent Application Atty. Docket No. EXMA-002PRV, entitled “Minimally Invasive Cardiac Force Transfer Structures,” to the inventors hereof and filed on even date herewith, the same being incorporated by reference in its entirely as part of the present invention.
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FIGS. 1A and 1B show perspective views of a healthy heart in systole and diastole, respectively. -
FIGS. 2A and 2B show perspective views of a diseased (enlarged) heart in systole and diastole, respectively. -
FIGS. 3A and 3B show perspective views of a diseased heart reinforced with an intravascular, tensioning structure of the invention in systole and diastole respectively. -
FIGS. 4A and 4B show perspective views dramatizing the progression of myocardial stretch (or infarct expansion) in a diseased, enlarged heart with the infarcted/ischemic zone shown as highlighted;FIG. 4C shows a perspective view of the heart ofFIG. 4B reinforced with an intravascular, tensioning structure of the invention. -
FIGS. 5A and 5B show anterior views of a heart with intravascular, tensioning structures of the invention being percutaneously deployed into various target vessels. -
FIGS. 6A and 6B show posterior views of a heart with intravascular, tensioning structures of the invention being percutaneously deployed into various target vessels. -
FIGS. 7A and 7B show exploded cut-away views of vessels in which a tensioning structure is placed, with each of the structures anchored transmyocardially. -
FIGS. 8A to 8F show various tensioning structures of the invention. -
FIGS. 9A and 9B show side views of various tensioning structures adapted for anchoring in branch vessels. -
FIGS. 10A to 10C show side views of various tensioning structures that incorporate tensioning springs. -
FIG. 11 shows a side view of a tensioning structure embodiment incorporating independent wire components interlaced with one another. -
FIG. 12 shows a side view of a tensioning structure embodiment incorporating a tubular body with radial anchor members. -
FIGS. 13A and 13C show side views of a ratcheting mechanism of an adjustable tensioning structure. -
FIGS. 14A to 14D show side-sectional views highlighting the process of positioning a tensioning structure in a delivery catheter. -
FIGS. 15A to 15D, 16A, 16B, 17A to 17E, 18A to 18D show side views of various tensioning structure anchor members in compressed and expanded orientations, variously. -
FIG. 19 shows a perspective view of a heart with sectional view of the coronary sinus and right atrium. -
FIG. 20 shows a perspective view of a heart with sectional view of the right atrium and right ventricle. -
FIG. 21 shows a perspective-sectional view of a heart incorporating an intravascular, tensioning structure secured by anchor members at the coronary sinus and the right ventricular outflow tract. -
FIG. 22A shows a perspective-sectional view of a heart incorporating an intravascular, tensioning structure secured inside the coronary sinus and at the ostium of the coronary sinus in the right atrium;FIGS. 22B to 22F show perspective views of a heart dramatizing highlighting the process of inserting and anchoring the distal end of a tensioning structure into the coronary sinus and anchoring the proximal end along the epicardial surface of the heart. -
FIG. 23 shows a side-sectional view of an intravascular, tensioning structure secured within a vessel in which another vessel is located below or underneath the target/treated vessel. -
FIG. 24 shows a perspective view of a heart with sectional view of the right ventricle and right atrium showing an intravascular, tensioning structure deployed in the coronary sinus and secured on one end to the right ventricular outflow tract. -
FIG. 25 shows a perspective view of a heart with sectional views of the coronary sinus and right atrium broken showing an intravascular, tensioning structure deployed in the coronary sinus and anchored on one end to the ostium of the coronary sinus in the right atrium. -
FIGS. 26A to 26D show side-sectional views of intravascularly deployed tensioning structures indicating various attachment points between tensile member and anchor components of the tensioning structure. -
FIGS. 27A to 27C show close-up views of various anchor structures in connection with various tensile member attachment points. -
FIGS. 28A to 28M show side views of various anchor structures and attached tensile member configurations for tensioning structures according to the invention. -
FIG. 29 shows a side-sectional view of a ratcheting mechanism of an adjustable tensioning structure. -
FIG. 30 shows a cross-sectional view of the distal tip of a delivery catheter system used to place tensioning structures. -
FIGS. 31A to 31C show side-sectional views of a vessel dramatizing the process of intravascularly deploying a tensioning structure comprising a deformable anchor using a balloon expandable, delivery system. -
FIGS. 32A to 32C show side-sectional views of an ostium to a vessel highlighting the process of deploying a self-expanding anchor member of a tensioning structure using a retractable sheath delivery system. -
FIGS. 33A and 33B show cross-sectional views of tensile members in a vessel illustrating variance in force distributions. -
FIGS. 34A and 34B , respectively, show a perspective view and a close-up view along line B-B of a tensioning structure anchor with a locking mechanism adapted for manually tightening the tensile member. -
FIGS. 34C to 34E show side views highlighting fabrication steps of the locking mechanism used inFIGS. 34A and 34B . -
FIGS. 35A to 35D show a side, perspective, and two-sided sectional views, respectively, of another anchor structure adapted for manual adjustment and locking of the tensile member. -
FIGS. 36A to 36D show top and perspective views, respectively, of a deployment system used to insert tensioning structures into or through myocardium. -
FIGS. 36E to 36H show perspective and side views, respectively, of two tensioning structures deployed into or through myocardium with delivery systems such as that shown inFIGS. 36A to 36D. -
FIGS. 37A to 37C show cross-sectional views of the heart broken in sections with the deployment system ofFIGS. 36A to 36D inserting the tensioning structures ofFIGS. 36E to 36H into/through the myocardium. - 38A to 38C show cross-sectional views of the heart broken in sections with an alternative deployment system used to insert the tensioning structures of
FIGS. 36E to 36H into/through the myocardium. -
FIG. 39A shows a cross-sectional view of the heart broken in sections with the tensioning structures ofFIGS. 36E to 36H deployed and secured into/through the myocardium in the right ventricle and the left ventricle;FIG. 39B shows a cross-sectional view of the heart with the tensioning structures embodiments ofFIGS. 36E to 36H deployed and secured along the valve annulus. -
FIGS. 40A to 40F show perspective views of a heart indicating various placement configurations of the tensioning structures ofFIGS. 36E to 36H. -
FIGS. 41A to 41D show a cross-sectional view of the heart, a perspective view and two top views, respectively, illustrating alternative tensioning structure approaches;FIG. 41E shows a side-sectional view taken along A-A of the anchor of the tensioning structure embodiment inFIG. 41D ;FIGS. 41F and 41G show a myocardial tensioning structure with an anchor that is adapted for manual adjustment and locking of the tensile member;FIG. 41H show a close-up view of the anchor formations shown inFIGS. 41F and 41G ;FIG. 41I shows a close-up, cross-sectional view of a proximal anchor from a cardiac valve annulus tensioning structure adapted for manual adjustment and locking of the tensile member. -
FIG. 42 shows an alternative, puncturing device used to deploy a tensioning structure. -
FIGS. 43A to 43D show two side-sectional views and two side views, respectively, illustrating the components of an alternative coaxially arranged delivery system used to deploy tensioning structures. -
FIGS. 44A to 44C show cross-sectional views of the heart broken in sections dramatizing an extravascular deployment and securing process for a tensioning structure that incorporates anchors at each end. -
FIGS. 45A to 45B show cross-sectional views of the heart dramatizing a catheter-based delivery and securing process for a tensioning structure that incorporates anchors at each end;FIGS. 45C to 45E show side views with components of the delivery system and process used to deploy and secure the anchor of the tensioning structure inFIGS. 44A to 44C and 45A and 45B within the myocardium or to a tissue surface;FIG. 45F to 45H show perspective views of an anchor member for a tensioning structure highlighting the expansion (e.g., plastic deformation via balloon expansion or self-expansion upon release from an external compression force) for the variation of the invention inFIGS. 45C to 45E;FIGS. 45I to 45L show three perspective views and one side view, respectively, of an alternative anchor member indicating the fabrication process for a tensioning structure. -
FIGS. 46A to 46K show side-sectional views of an integrated tensioning structure that functions as a puncturing device for a deployment system, an anchor member, and the tensile member;FIGS. 46L to 46M show a perspective view of the heart with a deployed and secured integrated tensioning structure shown as inFIGS. 46A to 46K;FIGS. 46N to 46P show a side view and two perspective views, respectively, of alternative delivery systems used to deploy integrated tensioning structures into or/through the myocardium;FIGS. 46Q and 46R show perspective views of additional integrated tensioning structures according to the present invention;FIGS. 46S to 46T show a perspective view and a side view, respectively, of another integrated tensioning structure;FIGS. 46U to 46Y show a perspective view, a side view, and side and top close-up views, respectively, of the integrated tensioning structure ofFIGS. 46N to 46O with a separate anchor attached. -
FIGS. 47A to 47D show a cross-sectional view of the heart dramatizing the process of deploying and securing a tensioning structure around and/or to a chordae tendineae or papillary muscle. -
FIG. 48A shows a side-sectional view of another tensioning structure compressed into a low profile within a deployment device for placement inside the heart cavity and attachment to the chordae tendineae and/or papillary muscle;FIG. 48B shows a side-sectional view of the deployed and secured tensioning structure ofFIG. 48A . -
FIGS. 49A and 49B show perspective views of a heart with parts cut-out highlighting the process of deploying and securing a tensioning structure to the chordae tendineae. -
FIGS. 50A and 50B show cut-away perspective views of the heart showing the process of deploying and securing the tensioning structure embodiment ofFIGS. 48A and 48B to the chordae tendineae. -
FIGS. 51A and 51B show close-up, side views of the end of a mechanism used to directly grasp, engage and reposition valve leaflets. - Having described the characteristics and problems of congestive heart failure in the background and summarized hereto, the treatment method and apparatus of the present invention will now be described in detail below. The variations of the invention described below may be used to provide a complete, comprehensive solution to treating congestive heart disease, and the contributing or associated co-morbid, anatomical, and physiological deficiencies. Addressing the multiple factors that affect or cause congestive heart disease can retard or reverse the implicated remodeling thereby treating or mitigating the congestive heart disease and associated symptoms.
- Before the present invention is described in such detail, however, it is to be understood that this invention is not limited to particular variations set forth and may, of course, vary. Various changes may be made to the invention described and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s), to the objective(s), spirit or scope of the present invention. All such modifications are intended to be within the scope of the claims made herein.
- Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as the recited order of events. Furthermore, where a range of values is provided, it is understood that every intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein.
- All existing subject matter mentioned herein (e.g., publications, patents, patent applications and hardware) is incorporated by reference herein in its entirety except insofar as the subject matter may conflict with that of the present invention (in which case what is present herein shall prevail). The referenced items are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior invention.
- Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a”, “and,” “said” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Unless defined otherwise herein, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
- With initial reference to
FIGS. 1A and 1B , an anterior view of a healthy heart in systole and diastole, respectively, is shown with directional arrows indicating motion of the heart in each phase. The greatcardiac vein 16 is shown on the surface of theventricle 18 of the heart. The greatcardiac vein 16 resides adjacent to the left anterior descending artery (not shown). - In
FIGS. 2A and 2B , perspective views are shown of a diseased (enlarged) heart in systole and diastole, respectively. An infarcted orischemic region 20 is shown to stretch from systole to diastole consistent with the progressive remodeling that occurs due to increased diastolic filling pressures exerted on the diseased tissue. A radial and axial expansion that is experienced by the heart leads to stretching or degenerative remodeling and concomitant organ enlargement. This enlargement can be localized along the anterior wall of the left ventricle, can be located or extend septally, can include the right ventricle, and/or can involve the mitral valve annulus. - Fundamentally, all tensioning structure aspects of the present invention comprise individually or in combination of several, components or devices including tensile member(s), anchor member(s) and deployment device(s). These components or devices are designed to be able to work in concert in order to facilitate and provide palliative or therapeutic cardiac reinforcement in the following critical target areas of the heart: 1) intravascular conduits, 2) cardiac valve annulus, 3) myocardium, 4) chordae tendineae and valve leaflets. The sub-sections broken-out below will further describe these specific aspects of the invention.
- Intravascular Conduit Tensioning Structures
- A number of embodiments of the present invention are provided mainly in the context of tensioning structures positioned and anchored within intravascular conduits to provide cardiac muscle support and reinforcement. Such intravascular conduit tensioning structures can be designed to be interchangeably deployed within various vascular conduits (arteries, veins, and branching vessels associated with these structures); or through these conduit walls directly into or through myocardium tissue, as described below. The primary vascular targets for intravascular conduit tensioning structure embodiments of the invention are in the venous tree (i.e., great cardiac vein, middle cardiac vein, small cardiac vein, anterior cardiac veins, oblique veins, and the coronary sinus). These venous structures generally run in symmetric apposition to their arterial equivalents, albeit at spaced intervals, where most myocardial infarcts originate. As such, in anatomical areas clinically known to have a significant prevalence of coronary artery disease, such as the left anterior descending, right coronary and circumflex arteries, the associated venous structures provide ideal target locations for catheter-based, percutaneous implantation of intravascular conduit tensioning structures to provide palliation and/or therapy.
-
FIGS. 3A and 3B show perspective views of a diseased heart reinforced with intravascularconduit tensioning structure 4 of the invention.Tensioning structure 4 limits myocardial stretch or infarct expansion by locally reinforcing the infarcted/ischemic regions 20 or other diseased sections of tissue, and limiting the tension applied to thetissue regions 20 in conjunction with diastolic filling pressure exerted directly against this diseased section. In this example, an intravascularconduit tensioning structure 4 is shown deployed in the greatcardiac vein 16 such that it targets ischemic orinfarcted tissue 20 associated with an occluded or stenosed left anterior descending artery or its emanating branches.Tensioning structure 4 can also be placed directly into the artery; however, it is preferred to anchor the structure in immediately apposed veins to eliminate concerns of thrombogenicity and adverse sequelae associated with placing foreign objects into arterial structures. Alternatively, the tensioning structures can also be positioned intravascularly, but anchored to the heart by extension into or through the myocardium. - All of the intravascular conduit tensioning structure embodiments are preferably positioned and deployed such that they extend from within the infarcted/ischemic region to tissue residing within or beyond the border region of this zone, or between spaced apart, border zone regions extending through, over, or under the infarct/ischemic zones.
Tensioning structure 4 are capable of applying a continuous or strain limiting tensile force to resist diastolic filling pressure while simultaneously providing a commensurate compressive force to the muscle wall to additionally or alternatively limit, compensate or provide therapeutic treatment for congestive heart failure and/or to reverse the remodeling that produces an enlarged heart. -
FIGS. 4A and 4B show perspective views of hearts highlighting the remodeling that occurs over time due to the inability of the ischemic/infarcted area 20 to withstand pumping pressures.FIG. 4A shows the heart withdiseased tissue 20 at the onset of remodeling. FurtherFIG. 4B also shows the result of remodeling with an aneurysmal-like bulging of tissue outward from the ischemic/infarcted area 20. This remodeling disrupts cardiac output by producing zones of hypokinesis, dyskinesis and/or akinesis, which further exacerbates the burden on the heart. The heart tries to compensate for this remodeling to maintain cardiac output by altering the compliance, contractility, and/or heart rate; in doing so the response only accelerates or perpetuates the degeneration. - As shown in
FIG. 4C , intravascularconduit tensioning structures 4 can be secured such that they effectively cover the ischemic/infarcted area 20 and also extend across thediseased section 20 at both ends where they are anchored. Accordingly, the tensioning structure inFIG. 4C is shown anchored in the greatcardiac vein 16 providing reinforcement and treatment to the weakenedregion 20 This provides sufficient reinforcement of the heart to regulate and withstand the internal forces that would otherwise perpetuate the remodeling process. In doing so, thetensioning structures 4 facilitate and maintain a more efficient and perhaps optimal, or at least-more optimal, wall motion throughout the cardiac cycle, thereby aiding in diastolic filling and systolic contraction at the diseased sections of theheart 20. As such, the precursors to remodeling (such as excess strain in the weakened, diseased sections of theheart 20 during systolic and diastolic cycles) are reduced, removed and even reversed. -
FIGS. 5A and 5B show an anterior view of a heart with tensioningstructure 4 of the invention being percutaneously deployed from acatheter delivery system 6 into the greatcardiac vein 16 and the smallcardiac vein 22.FIG. 5A also showstensioning structure 4 being deployed within the greatcardiac vein 16 and in 5B in the smallcardiac vein 22. These figures again illustrate the use of the tensioning structures to provide local reinforcement to the cardiac muscle. - The tensioning structures according to the present invention can be deployed within these venous structures as a stand-alone therapy for congestive heart disease or in combination with adjunctive treatment of the valve annulus. As such, it is noted that a multitude of such tensioning structures can be deployed about the heart in various, venous conduit structures, and as required anchored at various myocardial tissue positions to provide the reinforcement required to regulate and withstand the stresses and strains that would otherwise perpetuate the remodeling process. More than one
tensioning structure 4 can be deployed into a single coronary vein (or other vascular conduit), into or through the myocardium associated with or adjacent to the infarcted/ischemic zone(s) of the heart, or a combination of vascular and direct myocardial approaches (described below) to vary the reinforcement pattern and effect throughout the coronary bed. -
FIGS. 6A and 6B show a posterior view of the heart depicting deployment of an intravascularconduit tensioning structure 4 into the middlecardiac vein 28 and into thecoronary sinus 26 to provide additional reinforcement. InFIGS. 5B, 6A and 6B, thetensioning structures 4 are shown deployed in the greatcardiac vein 16, middlecardiac vein 28 andbranches coronary sinus 26 because the distal most target vessel should be accessed first. However, anchoring in the coronary sinus could be deployed first if desired or required by the operator.FIGS. 6A and 6B illustrate various proximal and distal anchor configurations that are preferred for the invention.FIG. 6A depicts the distal deployment of an intravascularconduit tensioning structure 4 into the middlecardiac vein 28 andFIG. 6B illustrates deployment of the tensioning structure and proximal anchoring in thecoronary sinus 26 with the distal anchoring in the leftmarginal vein 30. - The tensioning structures can also be positioned intravascularly, but anchored to the heart into or through the myocardium. As an example,
FIGS. 7A and 7B show a detailed, cut away anterior view of two tensioningstructures 4 anchored to the greatcardiac vein 16 at theventricle 24.Tensioning structure 4 inFIG. 7A is shown deployed within the vein with both ends/termination secured to thevessel using anchors 32 placed transmyocardially (into or through the myocardial wall 34). The tensioning structure shown inFIG. 7A incorporates atensile member 84 featuring an undulatingsine wave section 44, which provides an elastic or spring like loading to regulate or moderate expansion of the heart during diastole. In addition, thistensioning structure 4 incorporatesradiopaque marker bands 36 which facilitate evaluation of cardiac performance by allowing measurement of the distance betweenmarker bands 36 during the cardiac cycle under fluoroscopic guidance. Alternatively, themarker bands 36 could be fashioned from an echogenic material that can be located and visualized with ultrasonic imaging guidance, or otherwise similar means. -
Tensioning structure 4 inFIG. 7B is shown deployed within the greatcardiac vein 16. In this illustration, anchoring is achieved by positioning within abranch vessel 38 emanating from the greatcardiac vein 16 by locatinganchor 32 in the saidbranch vessel 38. This tensioning structure also features a taperedsection 40 to properly engage and deploy within a taperingvein section 42. The tensioning structure design shown inFIG. 7 radially supports a portion of the vein vessel at spaced apart intervals. This embodiment incorporates reduced diameter sections defining flexibletensile members 84 associated with radially, curved extensions designed to lock the tensioning structure to the vasculature. In an alternate embodiment (not shown) the tensioning structure could fully support the lumen of the vein, especially at spaced apart intervals. Either sort of design could be fashioned from materials or processed by various means to have sections or regions of varying stiffness customized or tailored to provide optimal performance characteristics. -
FIGS. 8A to 8E show a variety of alternate tensioning structures that can limit ischemia related myocardial stretch and infarct expansion.FIG. 8A shows an embodiment where the body of thetensioning structure 4 is a tensile member body 84 (e.g., tube, ribbon, strand, or wire, which can limit elongation with satisfactory elasticity based upon the selection of material properties and cross sectional area) incorporating at least one stress distribution feature such that the tensioning structure can apply tension against tissue without damaging the contacted tissue regions. A variety of materials can be used as thetensile member 84 of the tensioning structure, including PTFE, expanded PTFE, nylon, silicone, urethane derivatives, polyurethane, polypropylene, PET, polyester, superelastic materials (e.g., nickel titanium alloy), other alloys (e.g., stainless steel, titanium alloy etc.), metal (e.g., titanium), biological materials (e.g., strips of pericardium, collagen, elastin, vascular tissue such as a saphenous vein or radial artery, tendons, ligaments, skeletal muscle, submucosal tissue etc.) other alternate materials having the desired properties, or a combination of these and other materials. - The performance of the tensioning structure depends upon and can be tailored to the desired features. For example, when column strength is required, superelastic materials or other alloys or metals are preferred
tensile member bodies 84 of the tensioning structure. When pure tension is required and the tensioning structure is to be deployed through tortuous access points, more flexible materials such as expanded PTFE, polyester, or other suture type materials may be preferred as tensile members. When absorption or biological integration is desired over a period of time, biological materials such as strips of pericardium or collagen, or absorbable materials are preferred. -
FIGS. 8A to 8F show a variety of alternative tensioning structures of the invention.FIG. 8A also showsanchor members 32 secured to atensile member 84 at both ends oftensioning structure 4 to anchor the device to and within a conduit vessel. These anchor formations. 32 can alternatively be used to anchor the device directly into or through myocardial tissue for embodiments where the tensioning structures are placed or deployed extravascularly using surgical access to the epicardium, or using a catheter-based approach into the left ventricular cavity to target the endocardium.Anchors 32 are preferably fabricated from biocompatible materials commonly used in medical implants including nickel titanium (especially, for self-expanding or thermally-actuated anchors), deformable stainless steel (especially for balloon-expanded anchors), spring stainless steel, or other metals and alloys capable of being deformed using balloon catheters or other expansive means, or self-expanded to secure the tensioning structure to the vasculature, myocardium, or other tissue. Alternatively, theanchors 32 can be fabricated from superelastic polymers, flexible or deformable polymers such as urethane, expanded PTFE, or stiff materials such as FEP, polycarbonate, etc. -
FIG. 8B illustrates atensioning structure 4 that can at least impart partial radial support and be anchored to a vessel withanchors 32. In this variation of the invention, spaced apart anchor members are shown interconnected bytensile members 84. The multiple anchor members aid with cinching/compression of the local tissue region(s) to reduce wall stress while mitigating over-expansion of the tissue. Also, the multiple anchors can import or help to exert an elastic recoil effect during wall motion of the heart. That is, the tensioning structure would be fixed within the vascular conduit by frictional forces imposed upon the wall to maintain position of the structure in spite of cardiac wall motion. Therefore, the frictional fit provided by the multiple anchors along with thetensile member 84 mitigates over expansion of the heart. -
FIG. 8C shows a three-dimensional view of another embodiment of atensioning structure 4 deployed in a vessel where thetensile member 84 geometry features an undulating pattern (e.g., a sine wave pattern). Such a pattern may be provided in order to offer partial radial support to a vessel by conforming to and following the shape of the vessel lumen.FIG. 8D shows anothertensioning structure 4 that incorporates atensile member 84 featuring a three-dimensional undulation or switchback (e.g., a sinusoidal pattern) that fully supports the vessel lumen.FIG. 8E shows a variation ofFIG. 8C embodiment with the addition ofanchor formations 32. -
FIG. 8F shows an embodiment of thetensioning structure 4 configured in a specific geometry suitable for use in or about thevalve annulus 108. The design inFIG. 8F features switchbacks or a waveform at its center which when deployed about avalve annulus 108 can provide additional compressive radial force to the area opposite ofanchors 32. -
FIGS. 9A and 9B showvarious tensioning structures 4, adapted for anchoring inbranch vessels 30.Anchor members 32 provided therewith can be of various geometric configurations to enable stabilization of thesupport structure 4 within the vessel to provide reinforcement to the heart, especially by leveraging the complex three-dimensional tortuosity of the vessel anatomy to facilitate or achieve fixation or anchoring. - The tensioning structure embodiments shown in
FIGS. 10A to 10C feature a sinewave spring section 44 within thetensile member 84 of the structure. Thereby, the tensile member embodiments inFIGS. 10A to 10C provide an additional elastic section over straight members and provide another method to optimize cardiac wall motion to improve cardiac output. In FIG. 10A, thetensile member 84spring 44 is an undulating spiral-shape, (e.g., in the form of a sine wave). InFIG. 10B , thetensile member 84spring 44 is a helix. InFIG. 10C ,tensile member 84spring 44 features a geometric pattern, which enables a lower profile compression/confinement to enabling enable more efficient delivery via percutaneous or MIS means. - In
FIG. 11 , an embodiment of thetensioning structure variation 4 is shown, wherein thetensile member 84 incorporates individual wire, ribbon, suture, tube, or otherraw material segments 48 formed so as to interlace to and with each other. The segment terminations 46 are formed about the adjacent segment members creating overlap and are curled to interfere with the curled termination of the adjacent members. At the same time, the interlacedsegments 48 can expand and contract with the cardiac cycle, with the interferingterminations 46 placing a limit on the overall elongation. -
FIG. 12 illustrates an embodiment of theatensioning structure variation 4 featuring atensile member 84 with an undulating sine wave pattern (e.g., a sine wave pattern) formed along a cylindrical body. The cylindrical body shown inFIG. 12 provides complete radial support within the vessel where it is implanted. The shape also facilitates flexibility to for deployment in complex three-dimensional tortuous anatomies.Anchor formations 32 on both ends oftensile member 84 may be provided, in which case they will be oriented in a direction so as to resist the expansion of the heart when deployed within the vessel lumen. -
FIGS. 13A to 13C show various, adjustable,tensioning structures 4 to provide modification or adjustability of stiffness/resistance or force outputs by incorporating means to increase or decrease flexibility of the structure. The device ofFIG. 13A achieves the such adjustability utilizing removable loop structures 50 strategically positioned along thetensile member 84 that can communicate with the hub of thedeployment system 6 enabling a physician operator to selectively disengage or remove the same to increase the flexibility of the structure. The device ofFIG. 13B employs aratchet mechanism 176 with spring loadedball detents 52 along thetensile member 84 to achieve the same effect as described in 13A. The (ball)detents 52 are either resilient or spring loaded so as to selectively lock within a cut outsection 54 at the distal end of thecatheter deployment system 6 by engaging a push/pull mechanism moving the ball detents in a relative motion to astationary deployment system 6 sheath.FIG. 13C , shows an embodiment similar to that in 13B, wherein the aratchet mechanism 176 is provided that employs a sine wave-like structure instead of spring loaded ball detents to similarly facilitate adjustability. -
FIGS. 14A to 14D illustrate the process of constraining atensioning structure 4 into adeployment catheter system 6 sheath.FIG. 14A illustrates a generic embodiment of atensioning structure 4 containing self-expanding (e.g., superelastic) components (anchor 32 and/or tensile member 84) in an unconstrained, resting geometry.FIG. 14B illustrates the initial loading ofthea tensioning structure 4 within or into the inner lumen of thedeployment system 6 sheath using a hooked wire orstylet 8 to pull the structure within the lumen space.FIG. 14C continues the depiction of the loading oftensioning structure 4 into thedeployment system 6 sheath. Finally,FIG. 14D shows thedeployment system 6 sheath with the tensioning structure fully constrained therein. For deployment within a target vessel, the process shown inFIGS. 14B to 14D can generally be followed in reverse order with the exception that thestylet 8 pushes the tensioning structure out of the sheath once it is advanced to the desired location. Alternatively, thestylet 8 can maintain the position of the tensioning structure as thedeployment system 6 sheath is retracted. It should be noted that deployment of tensioning structures incorporating deformable components will be modified in that a balloon or other expandable mechanism can be used to deform pertinent components after placing at the desired implantable location. Details of deployment of at least some of the tensioning members, given the particulars of the device, may be apparent at least to skilled surgeons, interventionalists and technicians. - Deployment of these and other tensioning structures described below can be achieved 1) using a catheter-based approach to access the endocardium, vasculature, or epicardium; 2) surgically accessing the target site along the epicardium to insert and secure the tensioning structures, as described in later sections; or 3) using a combined surgical and catheter-based approach. Described below is the method and process of deploying tensioning structures into, within, or through the vasculature to reinforce the left ventricle about an infarcted/ischemic region, the mitral valve annulus to address mitral regurgitation or other insufficiencies, or other anatomy. It should be noted that this deployment process can be modified to enable positioning these tensioning structures intravascularly and then anchoring directly into or through the myocardium (or other tissue) to reinforce the anatomy without being confined to the vasculature. In addition, the deployment process can also be modified to enable positioning of these tensioning structures extravascularly with anchoring directly into or through myocardium (or other tissue) to reinforce the anatomy without being confined to the vasculature.
- The percutaneous approach to deliver and deploy a tensioning structure is illustrated in
FIGS. 6A and 6B . In these figures, an introducing sheath or guidingcatheter 5, as described above, is percutaneously inserted into theright atrium 58 such that the distal end of the delivery device enters thecoronary sinus 26. Thedelivery system catheter 6 can then be inserted through this introducing sheath such that it enters the venous system of the heart, and facilitates access to the target vessel at which tensioning/support structure 4 selected is to be deployed. The tensioning structure can take various forms such as shown inFIGS. 8A to 8E, 9A, 9B, 10A to 10C, 11, and 12 all of which can be preloaded in thedeployment catheter 6 prior to insertion into the vasculature. Once thedelivery system catheter 6 is positioned, thestylet 8 is held in position while the catheter is retracted. As shown inFIGS. 14A, 14B and 14D (viewed in reverse order), retraction of thecatheter 6 relative to thestylet 8 causes thetensioning structure 4 to extend beyond the end of thedeployment catheter 6 deploying in the target vessel as shown inFIGS. 5A, 5B , 6A and 6B.FIGS. 7A and 7B show proper securing of a tensioning structure according to the invention into a coronary vein after withdrawal of the delivery system catheter. - Various visualization features can be used to aid in proper deployment of a tensioning structure within the vasculature. A fluoroscopic marker and/or ultrasonic markers can be used to designate the side of the delivery system catheter in which the inner surface of the tensioning structure resides, thereby demarking the surface in which the tensioning structure curves.
- Additional Tensioning Structure Anchor Formations
-
FIGS. 15A, 15B , 16A, 16B, 17A, 17B, 17C, 18A and 18B provide alternative anchor types that can be deployed into themyocardium 34 itself, or though the myocardium and against the endocardium or epicardium of the proximate ventricle or atrium to provide interference with surrounding tissues to achieve the desired attachment.FIGS. 15C, 15D , 17D, 17E, 18C, and 18D provide additional anchor designs that can be deployed within the vessel lumen, through the vessel wall, into the myocardium, or through the myocardium and against the endocardium or epicardium or combinations thereof. In circumstances whereanchor formation 32 penetrates the vessel wall in venous structures, it is anticipated that slow flow hemodynamics will cause expedient closure and clotting of the pierced area. For myocardial placements, hemostasis is maintained by the musculature tending to close around the implant anchor preventing back-bleed. Common to each type of anchor is that their effect is achieved through interference with or engagement to surrounding tissues, though use of other anchoring approaches such as adhesive joints, tissue welding, and the like are within the scope of the present invention. -
FIGS. 15A to 15D, 16A, 16B, 17A to 17E, and 18A to 18D show various embodiments of anchors in constrained and expanded forms or states.FIG. 15A and 15C show aconstrained anchor 32 which when expanded takes the form of a helix spiral or screw as shown inFIG. 15B and 15D respectively.FIGS. 16A and 16B show ananchor formation 32 that features an expandable disc configuration.FIG. 16A shows a view of the disc in a constrained configuration and 16B show the expanded form of the same. The disc structure of the anchor formation in this embodiment may employ polymeric or metallic coverings attached to theanchor formation 32.FIG. 17A shows a collapsed/constrained view of a hook like wire structure that can engage tissue. Upon expansion, the anchor can take the form inFIG. 17B or 17C, the difference between the configurations ofFIG. 17B and 17C being theanchor formation 32 angle.FIG. 17D shows a hook-like structure similar to that in 17A in a constrained state with an expanded state subsequently shown inFIG. 17E . InFIGS. 18A to 18D, yet another variation of a hook-like anchor 32 is shown, in which a plurality of hooks is employment to increase the anchoring strength by distributing load among the hooks. As above these, anchor formations can be fabricated from superelastic materials to self-expand into contact with tissue structures or otherwise such as with deformable materials that require a balloon or other expanding device to deform the anchor formations into an enlarged, deployed state causing the anchor features of the anchor formations to expand into engagement with tissue structures capable of securing the tensioning structure at each end. Alternatively, theanchors 32 can be fabricated from superelastic polymers, deformable polymers, or rigid materials, depending on the anchor design and required dimensions. - Cardiac Valve Annulus Tensioning Structures
- An enlarged heart can also be associated with valvular dysfunction and disorders. As myocardial hypertrophy progresses and the circumference of the heart increases, valvular leaflets can begin to separate and result in incomplete closure, incompetence and blood regurgitation further exacerbating the degenerative cycle of failure of the heart. The present invention offers a solution for this disorder by the use of the tensioning structures in vascular conduits about the annulus of the valve to apply radial, tightening forces to restore valvular function by decreasing the annulus diameter and the related stress.
- The variations of the invention described in the section are well suited for use in annulus reinforcement at the primary vascular targets in the venous tree (i.e.,
coronary sinus 26, greatcardiac vein 16, and middle cardiac vein 28) especially since the coronary sinus anatomically navigates theatrioventricular groove 178 defining themitral valve annulus 108 as seen inFIG. 22A . This particular target location provides an ideal location for implantation of tensioning structures to provide palliation and/or therapy. The tensioning structures described in this section are capable of applying continuous or strain limiting tensile force to resist diastolic filling pressure at the cardiac valve annulus to provide therapeutic treatment for valve incompetency, its associated detrimental role in the congestive heart failure syndrome and/or to reduce the rate of or reverse the remodeling that produces an enlarged annulus or heart chamber. - With initial reference to
FIG. 19 , a perspective view of a heart is shown with thecoronary sinus 26 andright atrium 58, adjacent theinferior vena cava 78, broken in sections. Thecoronary sinus 26 is shown along theatrioventricular groove 178 of the heart. Thecoronary sinus 26 partially negotiates the mitral valve and enters the right atrium at anostium 76 located between theinferior vena cava 78 and thetricuspid valve 180. Access to thecoronary sinus 26 during percutaneous catheterization involves inserting an introducer sheath into a vein (e.g., femoral vein, subclavian, etc.) and feeding a catheter, under fluoroscopy or other imaging means, into the right atrium. An abrupt curve in the catheter, or steerability incorporated in the catheter or other separate guiding device, allows for feeding the end of the catheter through theostium 76 and into thecoronary sinus 26. From here, thetensioning structure 4 is advanced through the catheter or another guiding device, or positioned into the coronary sinus over the catheter (e.g., balloon catheter) into the desired positions within the coronary sinus (or other target vessel), and secured. - In
FIG. 20 , a perspective view is shown of a heart with theright atrium 58 andright ventricle 58 shown broken in sections exposed. The right ventricular outflow tract 72 (RVOT) is shown as a potential securing location for the atensioning structure 4. Other proximal anchoring locations include thefossa ovalis 182, theostium 76 of thecoronary sinus 26, theinferior vena cava 78, thesuperior vena cava 80, the right atrial appendage (not shown), the left atrial appendage (not shown), and the trabeculated tissue of theright ventricle 58. Alternatively, thetensioning structure 4 can be anchored into or through the right atrialfree wall 184 or theright ventricle 24 by attaching the proximal end of the tensioning structure to the myocardium or along the epicardial surface. - Alternatively, the
tensioning structure 4 can be passed through the right atrium or right ventricle, and anchored to the left ventricle or left atrium to provide further, more complete coverage of the tensioning structure around or about the mitral valve annulus. Of course, a similar approach can be used to cinch, reinforce, or repair thetricuspid valve annulus 108. -
FIG. 21 shows a perspective view of aheart 186 whosemitral valve annulus 108 is reinforced with atensioning structure 4 embodiment of the invention, with the device positioned and anchored to limit expansion of the mitral valve and also to tighten the mitral valve. Thetensioning structures 4 reduce radially, stiffen, and/or support the mitral valve by cinching the annulus similar to tightening as a purse-string; the tensioning structures also limit the localized forces exerted directly against the valve annulus. - In this example, the
tensioning structure 4 is again shown deployed in thecoronary sinus 26 such that it navigates the mitral valve annulus. Thedistal end 188 of thetensioning structure 4 is secured in the coronary sinus, great cardiac vein, or other branching vessel by ananchor 32, adapted for engagement to or through venous tissue, to which thetensile member 84 is secured (or integrated). Theproximal end 190 oftensioning structure 4 is secured at the right ventricular outflow tract 72 (RVOT) with anotheranchor 32 adapted for attachment to this specific attachment site. For example, a stent anchor having a significantly larger expanded diameter can be inserted into the RVOT and expanded (using a balloon or via self-expansion) to lock theproximal end 190 of thetensile member 84. - In contrast, other annulus supports that do not extend the reinforcement device into engagement with or beyond the ostium may provide insufficient coverage around the mitral valve annulus because the attachment position and the length of the anchoring modality within the coronary sinus dramatically reduces the angular coverage around the mitral valve annulus. Instead, securing the proximal end of
tensioning structure 4 to theRVOT 72 allows for reinforcing a larger amount of the mitral valve annulus since the tensioning structure is able to reinforce thevalve annulus 108 from the greatcardiac vein 16, along thecoronary sinus 26, past theostium 76 into theright atrium 58, along theinteratrial septum 192, past thetricuspid valve 180, into theright ventricle 24, and terminating at theRVOT 72, as illustrated in solid and broken line - When securing a tensioning structure to the right atrial free wall, the right ventricle, the left atrium, or the left ventricle, the guiding catheter or introducing sheath used to position the tensioning structure into the coronary sinus can be placed through the right atrium or right ventricle during surgical access to the interior of the right atrium. Alternatively, the catheter can be percutaneously placed and be advanced through the right atrial appendage (not shown) or
right ventricle 24 from the inside of the chest cavity. Once the distal end of the tensioning structure is positioned and the corresponding anchoring mechanism secured, the introducing sheath can be retracted, thereby allowing the proximal end of the tensioning structure to expand into the myocardium or against the epicardium of the right atrium or right ventricle. Alternatively the proximal anchor mechanism can be manually set by deforming the same using a balloon or other expansion mechanism, as described below. Still further, the proximal anchoring mechanism can be manipulated into contact with the left atrium or left ventricle and secured, also to provide increased coverage of the tensioning structure around the annulus. Similarly, the guiding catheter or introducing sheath used to position the tensioning structure into the coronary sinus can be used to position the proximal anchoring mechanism into or through the myocardium of the right atrium or right ventricle. Additional features can be required for this approach including a puncturing mechanism to penetrate into or through the myocardium, as will be described below. -
FIG. 22A shows a side view of the heart open in sections, with atensioning structure 4 secured within thecoronary sinus 26 with a distal anchor (not shown) and aproximal anchor 32 attached at theostium 76 into thecoronary sinus 26. The distal anchor can comprise one of the various anchor formations described in the preceding sections of the detailed description. As shown inFIGS. 21, 22A to 22F, 24, and 25, thetensioning structures 4 of the invention generally extend into engagement with or beyond theostium 76 of the coronary sinus, thereby covering the mitral valve annulus from the greatcardiac vein 16 past thecoronary sinus ostium 76. This significant amount of coverage provides sufficient reinforcement to the annulus to regulate and withstand the internal forces that would otherwise perpetuate the remodeling process and/or adversely affect valve competency. - Securing the
tensioning structure 4 proximal end at the ostium of the coronary sinus is facilitated by a device design including a stop feature integrated with theproximal anchor 32 to prevent migration of thetensile member 84 back into the coronary sinus. This can be accomplished by a myriad of anchor member embodiments described below. Theseproximal anchors 32 can be, for example, plastically deformable from a small diameter to an enlarged profile (using a balloon expandable catheter) to allow positioning part of the anchor in the right atrium outside the periphery of theorifice 76 thereby acting as a stop which interferes with the atrial wall to prevent the anchor from dislodging into the lumen of the coronary sinus. Alternatively, the proximal anchors 32 can be fabricated from superelastic material capable of elastically deflecting into a low profile for deployment and returning towards a preformed shape once external compressive force is removed. This preformed shape could provide the required interference at the ostium as well. - A minimally invasive surgical approach for deployment of the present embodiment is provided in
FIGS. 22B to 22F. These figures show atensioning structure 4 that has itsproximal end 190 secured through the right atrium and against the right ventricular epicardium. The tensioning structure can be deployed using a catheter delivery system capable of puncturing through theright atrium 58 from inside the heart to deploy and secure the proximal anchor after positioning the distal anchor. Alternatively, as shown inFIGS. 22B to 22F, a surgical approach may be to puncture the right atrium from the epicardial surface and then place adelivery system catheter 6 into the coronary sinus. After deploying and securing thedistal anchor 32, the delivery system catheter is retracted past the insertion site leaving the tensioningmember 84 behind in thecoronary sinus 16 andright atrium 58. A purse-string can be used to ensure hemostasis at the insertion site, around the delivery catheter during deployment of the distal anchor or around thetensile member 84 after removing the delivery catheter. Theproximal anchor 32 is then engaged and secured against the insertion site 194, theright atrium 58, the right ventricle 24 (as shown inFIG. 22F ), theleft atrium 74, theleft ventricle 18, or other anatomic structure capable of maintaining tension to the tensioningmember 84. It should be noted that the same approach can be used to deploy the tensioning structure through theright ventricle 24, theinferior vena cava 78, thesuperior vena cava 80, or other anatomy. -
FIG. 23 shows a side-sectional view of a coronary sinus 26 (or other vessel) that overlays or is otherwise in close proximity to a coronary artery (or other vessel) with atensioning structure 4 positioned and secured within the coronary sinus. As shown inFIG. 23 , the spaced apartdistal anchors 32 of the tensioning structure are short relative to the length of the coronary sinus (or other target vessel) and are interconnected by the more flexibletensile member 84, so they can be positioned and secured away from the overlayingvessel 82. That way, the tensioning structure does not occlude the overlaying vessel. More than twoanchors 32 can be used to further distribute the forces along the coronary sinus (or other vessel) and ensure overlaying vessels are not compromised once the tensioning structure is secured. By placing anchors on each side of the overlayingvessel 82, the coronary sinus is supported throughout this region to ensure the tightening, or compressive forces exerted by thetensile member 84 do not constrict the overlayingvessel 82. -
FIG. 24 shows a perspective view of aheart 2 cut away broken along theright atrium 58 andright ventricle 24 with anothertensioning structure embodiment 4 deployed within thecoronary sinus 26 and having theproximal anchor 32 secured to theRVOT 72. As opposed to the embodiment inFIG. 21 , in which theproximal anchor 32 is fabricated as a tubular member or spiral component configured to contact theRVOT 72 throughout a cross-sectional region of tissue, the embodiment inFIG. 24 shows aproximal anchor 32 defining a hook or pigtail capable of taking advantage of the tortuosity of theRVOT 72 relative to the coronary sinus which grapples or engages onto or within theRVOT 72. -
FIG. 25 shows a perspective view of a cut-away heart with a tensioning structure positioned within thecoronary sinus 26 and secured to theostium 76 with the use of a balloon expandable stent (or self-expanding stent) as theproximal anchor 32. The fully expanded diameter of the stent (anchor 32) is larger than the inner diameter of thecoronary sinus 26 to ensure that the stent does not migrate back into thecoronary sinus 26 upon deployment. This ensures that the forces, which are applied when deploying the tensioning structure, are maintained continuously. - Such proximal anchor configurations are easy to deploy since, after securing the distal anchor, tension is applied to the
tensile member 84 by retracting the proximal anchor until the appropriate tightening or cinching of the valve annulus is achieved; at this position, a balloon can be used (for balloon expandable proximal anchors) to over-expand the proximal anchor such that the region outside the coronary sinus orifice has a substantially larger outer diameter than the inner diameter at the orifice. This configuration permanently locks the tensioning structure in the plastically-deformed position. Self-expanding proximal anchors can be released from an external, compressive sheath that maintains the anchors in a compressed, low profile state during positioning pre-deployment. It should be noted that such proximal anchors can be configured to be used at any vessel ostium that is to be reinforced. It should also be noted that other expandable (balloon deformable or self expanding) anchor configurations can be used at the orifice with or without barbs that actively engage the interior surface of the tissue (i.e., right atrial wall). -
FIGS. 26A to 26D show side-sectional views ofvessels 56 containing the distal anchor region of a tensioning structure illustrating various attachment points between thetensile member 84 andanchor 32.FIG. 26A shows an embodiment where thetensile member 84 is bonded to the near, insideedge 196 of theanchor 32.FIG. 26B shows an embodiment where thetensile member 84 is bonded to the far,inside edge 197 of theanchor 32.FIG. 26C shows an embodiment where thetensile member 84 is bonded to the near,outside edge 198 of theanchor 32. Finally,FIG. 26D shows an embodiment where thetensile member 84 is bonded to the far,outside edge 199 of theanchor 32. Indeed, the tensile member can be bonded to any region of theanchor 32 as required or desired. Suitable fixation methods to join thetensile member 84 to theanchor 32 include chemical bonding, tying, welding, adhesive bonding, mechanical crimping, combinations thereof or any other suitable fixation means. - When the anchor provided used is a stent like anchor formation (balloon expandable or self-expanding), as shown in
FIGS. 26A to 26D, the anchor preferably has a length that is preferably more than 1.5 times the inner diameter of the target vessel (e.g, coronary sinus). Stent-like anchors are most suitable for small and medium diameter vessels, such as the coronary sinus; other anchors may be better suited for other attachment points, such as theRVOT 72. The location of the bond/attachment betweentensile member 84 andanchor 32, as shown inFIGS. 26A to 26D, ensures stability of the anchor as tension is applied because tension causes the anchor to slightly rotate in the target vessel increasing the engagement of the anchor to the target vessel and preventing axial dislodgement. If the tensile forces are applied in a purely axial manner, instead of providing some torque, then the risk of dislodgment increases, but since a slight rotation is caused by tension and the length of the anchor is greater than the inner diameter, the anchor pull-out forces increases as applied tension to the anchor increases. - It should be noted that the
tensile member 84 can be integrated to the anchor as opposed to being bonded or joined as separate components. For the integrated configuration, these anchors can be fabricated from one or more strands of material that form a helix, mesh, open cell, or other anchor geometry and emanate into one or more strands that produce the tensile member. For the non-integrated condition, any anchor configuration can be bonded/attached to a tensile member to form these two components of the tensioning structure. - It will often be preferred to maximize flexibility of the
tensile member 84 to aid in the traversal of tortuous anatomy in order facilitate percutaneous and/or minimally invasive surgical approaches structure of deployment. Accordingly, materials that are most suited to fabricatetensile member 84 will have a high degree of flexibility in the bending direction or, otherwise stated, have zero or minimal buckling resistance. In addition, this preferred material should have resistance to tensile elongation unless elasticity is a desired component for the tensile members, in which case, the tensile member enables temporary elongation with corresponding recoil. Materials that creep are not preferred since they might prompt the need for undesired, post-surgical tensioning structure adjustment. -
FIGS. 27A to 27C show close-up views of threeanchor configurations 32 and the attachment of non-integratedtensile members 84 to the anchors.FIG. 27A shows ananchor 32 formed from a mesh or braid of raw material strands and a tensile member tied to the intersection of the strands. Alternatively, as alluded to above,tensile member 84 can be glued, ultrasonically welded, spot welded, soldered, or bonded with other means, depending on the types of materials used. It should be noted that the anchor(s) 32 and/or tensile member(s) 84 can be fabricated from metallic materials such as stainless steel, nickel titanium, titanium, or other metal or alloy; superelastic polymers; biological materials such as pericardium, collagen, submucosal tissue, skeletal muscle, and vascular tissue (e.g., saphenous vein, radial artery, or other artery or vein), genetically engineered tissues; or other materials such as nylon, polyester, polypropylene, expanded PTFE, polyimide, silicone, PET, polyurethane, urethane composites, thermoplastic materials, thermoset plastics, composites of such materials, or other biocompatible material.FIG. 27B shows ananchor 32 fabricated from a tube or other raw material geometry laser cut into the desired pattern of cells and other features with atensile member 84 bonded thereto. It should be noted that laser cutting, chemical etching, water-jet cutting, or other cutting mechanism can be used to create the anchor and the tensile member as an integrated unit from a single piece of raw material (tube stock, sheet stock, or other geometry). -
FIGS. 28A to 28M illustratevarious anchor 32 embodiments with attached or integratedtensile members 84.FIG. 28A shows ananchor 32 with radial protrusions to further embed the anchor into the target vessel wall and increase the pull-out forces as tension is applied through thetensile member 84.FIGS. 28B to 28F show alternative anchor embodiments with bonded or integratedtensile members 84 that incorporate radially extending elements ideally suited for the proximal anchor configured to be secured to the ostium of the coronary sinus (or other target vessel), the trabeculae of the right ventricle, the interatrial septum, the inferior vena cava, the superior vena cava, or theRVOT 72. The anchor embodiments inFIGS. 28A to 28F can also be used to securetensioning structures 4 within the myocardium or against the epicardial or endocardial surface during surgical or catheter based reinforcement procedures where thetensioning structures 4 are positioned into or through myocardium. -
FIGS. 28G and 28H show alternative anchor embodiments with attached or integrated tensile members ideally suited for attaching to any size vessel (e.g.,coronary sinus 26,RVOT 72,inferior vena cava 78,superior vena cava 80, etc.), the ostium to the target vessel, the fossa ovalis, or other anatomic structure. The anchor embodiments inFIGS. 28G and 28H can also be used for tensioningstructures 4 that are inserted through myocardial tissue where the anchor members abut the endocardial or epicardial surface, depending on placement location of the tensioning structures, and do not further penetrate into or through the endocardial or epicardial surface engaged to secure the anchor.FIGS. 28I to 28M show additional anchor embodiments with secured or integrated tensile member(s) suited for any size vessel. These embodiments directly engage the vessel and partially or completely penetrate into the vessel wall to secure the tensioning structure. Again, all of these anchor embodiments can be used to securetensioning structures 4 into or through myocardial tissue for indications where the tensioning structures are used to reinforce an infarcted/ischemic zone by passing tensioning structures along or through the zone from outside the border of the zone into the region of the zone, or from opposing sides of the zone passing through the infarcted/ischemic zone. - Post placement and anchoring of tensioning structures it would be desirable to adjust the tension in the structure intraoperatively and post operatively as needed. For example,
FIG. 29 shows an embodiment of the proximal anchor that incorporates a mechanism to variably tighten thetensile member 84 relative to an anchor. A ratcheting mechanism is shown with elastic balls or other teeth-like mechanisms able to retract in one-direction to increase tension applied to thetensile member 84 and prevent release of the tension applied. Such a mechanism enables variably adjustment and tightening of the annulus, or other tissue region, intraoperatively and postoperatively as the tissue heals and recovers. - When deploying tensioning structures to reinforce or tighten a mitral or tricuspid valve annulus via catheter-based approach, an introducing sheath or guiding catheter can be percutaneously inserted into the
right atrium 58 such that the distal end enters thecoronary sinus 26. Alternatively, the delivery system can be inserted directly through the right atrium. (e.g., at the right atrial appendage) or the right ventricle to access the coronary sinus during surgical procedures. A catheter-based delivery system approach would involve insertion through an introducing sheath positioned in the femoral vein into the venous system of the heart such that it facilitates access to the target vessel into which thetensioning structure 4 is to be deployed. The tensioning structure can take various forms as described above all of which can be preloaded in the deployment catheter prior to insertion into the vasculature. - In the preferred embodiment, the delivery system catheter is a balloon catheter capable of expanding with pressure to an enlarged diameter forcing the tensioning structure anchor (especially those with stent-like characteristics) radially outward into engagement with the interior surface of the vessel or other associated anatomy. After securing the first anchor, other anchors can be sequentially (or simultaneously) deployed with the same or other balloons. Alternatively, the anchors can be self-expanding and constrained within a guide catheter used for deployment. A stylet or multiple stylets can be used to sequentially or simultaneously deploy the anchors as tension is applied. It should be noted that balloon expandable and self-expanding anchors can be utilized on the same tensioning structure and the deployment catheter can incorporate balloon catheters and guiding catheters collaborating to deploy the anchors at targets. Various visualization features can be used to aid in proper deployment of tensioning structures within the vasculature. For example, a fluoroscopic marker and/or ultrasonic markers can be used to designate the side of the deployment catheter in which the inner surface of the tensioning device resides; this demarks the surface in which the tensioning structure curves.
- An important benefit of percutaneous approach to place and anchor tensioning structures is the ease of deployment and the rapid healing post procedure. The endovascular approach to remotely access the target sites eliminates the need for traumatic or more invasive surgical methods to access the target structures. The incision to facilitate positioning and subsequent delivery and deployment of the support structures is minimal, most likely with only local anesthesia, and accordingly the procedure can be conducted on an outpatient basis. The technique typically involves navigating the distal end of a catheter along a tortuous path extending along the lumens defined by the patient's vasculature between a point of entry into the patient's body and the remote target site.
- It would be advantageous if the cross-sectional dimensions of such catheter or less invasive deployment system, and constrained tensioning structures could be reduced. This would ease the task of navigating such deployment systems along tortuous paths through body lumens, especially lumens having relatively small internal diameters. Minimizing the profile of the tensioning structures and deployment systems also facilitates insertion of tensioning structures described in this specification through heart tissue (myocardium) or other tissue without compromising integrity of the tissue or causing excess bleeding through the tissue.
- The delivery system and process for placement of the
anchors 32 can also feature means to facilitate adequate fluoroscopic visualization of vessel structures where the structure is to be positioned to ensure optimal performance. The ideal design for such a delivery system (catheter) is to include a lumen at the distal tip of such means having sufficient cross-sectional area to facilitate suitable flow rates for injections of conventional contrast media used in standard interventional catheterization procedures. The lumen exit at the distal tip can be arranged so as to communicate along the length of the catheter body such that the proximal end can be connected to manual or automatic injection means, allowing the operator to hydraulically force the contrast media through the luminal space within the catheter. The contrast can then exit at the distal end of the catheter at the luminal opening or port and flow into the blood stream. The injected contrasted would then enable kinetic visualization and mapping of the vasculature as it flows with the blood when monitored under a fluoroscope. - The ability to image at the distal tip of the deployment means is also ideal since the apposition of the
anchor 32 relative to the vessel wall can be well characterized prior to application of tension. Also, theanchor 32 and the surrounding vessel wall can be assessed for damage to the wall due to catheter manipulations, deployment of theanchor 32, or damage at theanchor 32 itself. -
FIG. 30 shows a cross-sectional view of a representativedistal tip 86 of a delivery system catheter capable of deploying the tensioning structure, illustrating theexpandable balloon 92, a balloonexpandable anchor formation 32, a lumen forcontrast injection 88, and aguide wire lumen 90. The lumens can be configured in various geometries using standard plastic processing techniques such as extrusion. Ideally, theguide wire lumen 90 is located at the center of the catheter to facilitate coaxial delivery of the delivery catheter over standard guide wires in the preferred embodiment. Thecontrast lumen 88, can be positioned to exit at the tip or cut out of the sidewall of the lumen. Thecontrast lumen 88 diameter should be ideally sized to allow sufficient flow rates to inject radiopaque contrast media using standard interventional technique. -
FIG. 31A shows thedistal segment 86 of the delivery system catheter in a vessel prior to deployment of adistal anchor 32. Theunexpanded balloon 92 with ananchor 32 crimped over its outer surface is shown traveling over aguide wire 94 to the distal vessel segment deployment target.FIG. 31B displays the expansion of theexpandable balloon 92 inflated preferably with saline to deploy (i.e.,plastically deform) theanchor 32 against the inner lumen of the vessel.FIG. 31C exhibits the retraction of the delivery catheter (in the direction of the arrow shown in the illustration) leaving the deployedanchor 32 behind at the vessel target location withtensile member 84 attached and extending proximal to the anchor. Thetensile member 84 can be housed within theguide wire lumen 90,contrast lumen 88, a lumen of it's own (not shown), or outside the catheter to facilitate smooth, untangled delivery of thetensile member 84. -
FIGS. 32A, 32B , and 32C shows the deployment of aproximal anchor 32 into the ostium of the coronary sinus located within theright atrium 76. In this embodiment, theanchor 32 is of the self-expanding variety and is shown with a retractable sheath system at the distal tip of thedelivery system catheter 86. This system facilitates deployment and constraining of the anchor by the operator. InFIG. 32A , the delivery system catheter tip is shown with thetensile member 84 extending beyond the distal tip of the catheter. The termination of the tensile member is configured for attachment to a balloonexpandable anchor 32 as shown inFIG. 31C or alternatively to a self-expandinganchor structure 32 as shown inFIG. 32C .FIG. 32B displays the self-expandinganchor 32 structure partially deployed in thecoronary sinus 26.FIG. 32C displays the self expandinganchor structure 32 fully deployed within theostium 76 with a flared or trumpeted end to enable mechanical lock up to fully secure the tensioning structure at the ostium. -
FIG. 33A andFIG. 33B show cross-sectional areas of a coronary sinus 26 (or similar conduit) and thetensile member 84.FIG. 33A shows a smallercontact surface area 164 of thetensile member 84 to the inside wall of thecoronary sinus 26 than that ofFIG. 33B . A largercontact surface area 164 provides a means to reduce the stress from the loading of thetensile member 84 to thecoronary sinus 26 and other adjacent venous structures to minimize the propensity for abrasion/trauma to or through the vessel wall. As such, the tensioningmember 84 of thetensioning structure 4 described above can be fabricated from a rectangular or ovalized strip of flexible tensioning material such as expanded PTFE, FEP, polypropylene, PET, polyester, nylon-based materials, silicone, urethane derivatives, absorbable materials, cellulose acetate, regenerated cellulose, biological materials (e.g., pericardium, submucosal, saphenous vein, other vein or artery, skin, tendon, other collagen based material, strips of skeletal muscle, etc.). When metals or alloys are used as the tensioningmember 84, they can be fabricated into a mesh, helix, sinusoid, elliptical bar, rectangular bar, or other geometry designed to distribute the stress applied to the vessel wall or other tissue structure when tension is applied to tighten the annulus or otherwise apply forces to the vessel or other tissue. Alternatively, a jacket of these same materials can be coaxially arranged over an inner tensile member component to achieve the same effect. -
FIGS. 34A to 34E and 35A to 35D show additional proximal anchor embodiments capable of securing the tensioning structure to the coronary sinus orifice. These embodiments show tightening capabilities described inFIG. 29 above.FIG. 34A and 34B show asplit wall anchor 166 designed to plastically deform into an expanded orientation partially within the coronary sinus and partially expanded beyond the outer diameter of the coronary sinus orifice to prevent movement or relaxation of the tensioning structure. A ratcheting or ball locking mechanism is incorporated in the side of the anchor such that as the tensioningmember 84 is retracted relative to the anchor, the tensioning member becomes incrementally tighter as the locking balls or teeth are pulled into the mating latch of the anchor. This embodiment can alternatively be fabricated as a self-expanding anchor by utilizing superelastic components that transform into or maintain their austenite phase during deployment. -
FIGS. 34C and 34D show a laser cut anchor locking mechanism pre- and post-forming. The anchor embodiment inFIG. 34E incorporates the formedlocking mechanism 168 inFIG. 34D attached to the anchor mechanism, in this case a balloon expandable (or self-expanding) stent. Thelocking mechanism 168 inFIGS. 34D and 34E consists of radial extensions cut into the raw material as shown inFIG. 34C defining a one-way deflectable lock allows that a tensile member containing ratcheting teeth, balls, or other mechanism to move one way while inhibiting movement in the opposite direction.FIG. 34E shows the completedanchor assembly 32 which defines a mesh or open cell stent-like anchor (plastically deformable or self-expanding) capable of anchoring the tensioning structure to the coronary sinus orifice and orienting the mesh or open cell structure to produce a locking mechanism capable of engaging and restraining the ratchet teeth, balls, or other locking mechanism of the tensile members. -
FIGS. 35A to 35D show another anchor embodiment capable of securing the tensioning structure to the coronary sinus orifice and incorporating a latching mechanism capable of engaging and locking mating components (teeth, balls, or other feature) of thetensile member 84 to enable manual tightening or adjustment of the tensioning structure once deployed.FIGS. 35A and 35B show a side view and a perspective view of an anchor containing a self-expanding (or plastically deformable) anchoring loop orloops 156 capable of engaging the right atrial, endocardial surface immediately adjacent to the coronary sinus orifice to prevent migration of the anchor into the coronary sinus once deployed and tension is applied. The housing that holds theanchoring loop 156 preferably constructed from a material that provides spring-like properties. The groove and slot shown inFIGS. 35A andFIG. 35B would act in combination as aliving hinge 154 facilitating passage of theball detents 52 orknots 102. The inner conical lead-in 170 in combination with theliving hinge 154 allows unidirectional ratcheting.FIG. 35C shows thetensile member 84 with locking features (in this case,balls 52 that engage themating locking mechanism 168 of the anchor) being pulled through a channel to move toward the orifice thereby applying tension to the tensioning structure while preventing movement of the tensioning element in the opposite direction.FIG. 35D shows additional features of the deployment system. In this embodiment, the guiding catheter contains a channel through its side wall for the tensile member to pass such that tension can be applied through the guiding catheter whereby the distal segment of the guiding catheter can stabilize the anchor while applying the desired tension to ensure the tensioning member locking mechanism engage the mating components of the anchor. This channel through the sidewall can also incorporate a blade (movable or stationary) capable of cutting the excess tensile member after the tensioning structure is deployed and tightened in place. - The deployment systems and tensioning structures described above for reinforcing a mitral or tricuspid valve annulus can alternatively be used to reinforce infarcted and ischemic zones by positioning and securing tensioning structures intravascularly, as described previously, or directly into or through myocardium, as described below.
- Myocardial Tensioning Structures
- The
tensioning structures 4 described above can additionally be positioned through or into myocardium to locally reinforce infarcted/ischemic zones and maintain wall motion adjacent to and throughout those zones. This aids cardiac output by increasing the left ventricular ejection fraction and wall motion throughout the heart thereby improving efficiency and reducing the effects of congestive heart failure aiding the process of reverse remodeling. - The delivery systems described above can additionally be used to insert the anchors of the tensioning structures into or through myocardium where they engage the myocardium, the epicardium, or the endocardium and attach the tensioning structures to the heart. These delivery systems can percutaneously access the desired attachment site through a catheter-based approach where a guiding catheter is passed retrograde through the aorta and into the left ventricle, transeptally through the interatrial septum from the right atrium and past the mitral valve into the left ventricle, or through the right atrium past the tricuspid annulus and into the right ventricle. With this catheter-based approach the tensioning structures are individually deployed into engagement with trabeculae or other endocardially located anatomic structures, through the endocardial surface into the myocardium, or through the myocardium where they engage the epicardial surface.
- Alternatively the catheter-based or minimally invasive surgical approaches can access the epicardial surface by puncturing the right or left atrial appendage (which can be closed after the procedures), the inferior or superior vena cava, or other venous structures that can be closed readily after performing the procedure. In these cases, the tensioning structures are deployed through the epicardial surface into the myocardium or through the myocardium into engagement with the endocardium.
- The delivery systems described above can also be used to deploy the tensioning structures through a thoracotomy, thoracostomy, subxiphoid access, median sternotomy or other surgical access. This way the deployment system can access the heart along the epicardium or endocardium and position the tensioning structures at the desired locations in the heart.
- Many of the embodiments described previously incorporate a
tensile member 84 terminating atanchor mechanisms 32 at each end. The embodiments described below are specially configured to be positioned into or through the myocardium and define anchor mechanisms augmented by the inherent structure and deployment process and/or can incorporate one or more anchors to aid in positioning and securing thetensioning structures 4 in place. -
FIGS. 36A to 36D show a delivery system capable of simultaneously and/or independently inserting opposite ends or terminals of a tensioning structure through or into myocardium via a catheter-based or surgical approach. The discussion for this embodiment is described from a surgical approach initially inserting the tensioning structures through the epicardium to access the myocardium; although it should be noted that a catheter-based approach can be utilized with these embodiments if modified for percutaneous access and fluoroscopic visualization requirements facilitating insertion of the tensioning structures either through the endocardial surface to access to or through the myocardium. The delivery system embodiment shown inFIGS. 36A to 36D involves a pair of puncturing devices fabricated from superelastic materials (e.g., nickel titanium), metals (e.g., titanium) or other alloys (e.g., spring stainless steel) exhibiting sufficient elasticity and spring characteristics to compress into a low profile for insertion through a tissue surface and controllably expand as the puncturing devices are extended beyond the confines of the sheath used to apply the external force to compress the puncturing devices. The delivery system embodiment inFIGS. 36A and 36B show the puncturing devices compressed into a low profile inside a sheath (single lumen or multi-lumen with a dedicated lumen per puncturing device) having sufficient radial strength and column strength to straighten the puncturing devices. Each puncturing device incorporates a holder that engages a free end of thetensile member 84 of the tensioning structure, and advances or retracts thetensile member 84 as the puncturing device is advanced or retracted. This delivery system enables placing an independent tensile member 84 (without anchors) into or through myocardium and securing it to apply tension along an infarcted/ischemic zone to reinforce the zone. As implanted, the tensile member can contract and expand in conjunction with the wall motion about the border of the infarcted/ischemic zone. -
FIGS. 36E to 36H show perspective and side views of two, 3-dimensional, cinching, tensioning structure embodiments that inherently define anchors at each end of the tensioning structure. These embodiments comprise at least one tensile member 84 (in these embodiments, only one tensile member is shown) supporting at least one stress distributing tube either secured 146 or movable 148 in relation to thetensile member 84. - As
FIGS. 36E to 36H show, the stress distributing tubes, secured 146 to thetensile member 84, are located at the proximal end naturally forming a loop when opposite sides of thetensile member 84 are positioned at spaced apart insertion sites. This loop forms ananchor 96 and the secured 146 stress distributing tubes prevent highly localized stress from being applied against the tissue surface at the insertion or exit points of thetensile member 84. - In the embodiment shown in
FIGS. 36E and 36F , the secured 146 stress distributing tubes are located at the insertion sites for theproximal anchor 96 and the exit sites for thesides tensile member 84. As such, the stress distributing tubes locally increase the stiffness of the tensioning structure at the insertion and exit sites to direct the tension applied to the tissue region between the stress distributing tubes. In addition, the secured 146 stress distributing tubes increase the surface area of the tensile member at the insertion and exit sides to distribute the force applied against the tissue along a larger surface area. - In the embodiment shown in
FIGS. 36G and 36H , the secured 146 stress distributing tubes are located along theproximal anchor 96 and between the insertion and exit sites to regulate the amount of cinching, upon applying tension to thetensile member 84, along the plane defined by the length of theproximal anchor 96 loop and the plane defined by the space between the insertion and exit sites; two of the three planes defined by the 3-dimensional cinching tensioning structure. The third plane is defined by the relationship between the secured 146 and movable 148 stress distributing tubes. In this embodiment, the secured 146 stress distributing tubes limit the cinching and can vary the ratios of cinching along each plane by changing the cross-section thickness, the material type, the length of the tubes, or other parameter capable of making the tubes more flexible or rigid. - The
secured tubes 146 can be fabricated by injection molding, extruding, ultrasonic welding, adhesive bonding, or by mechanically securing a covering over thetensile member 84 at defined locations. Thesecured tubes 146 can comprise a tubular, elliptical, rectangular, or other cross-sectional geometry. Thesecured tubes 146 can consist of materials such as expanded PTFE, silicone, cellulose acetate, regenerated cellulose, polyester, polypropylene, nylon-based materials, urethane or its derivatives, biological tissues (e.g., vessels, collagen based tissue structures, etc.), metals, alloys, other material capable of distributing stress over a length of the tensile member, or a composite of such materials. - The movable 148 stress distributing tubes can be fabricated with the same processes, parameters, and materials as the secured 146 tubes described above provided the
tensile member 84 can be pulled through the movable 148 stress distributing tubes. After placing the free ends of thetensile member 84 through myocardial tissue and pulling the free ends beyond the tissue surface, the movable (148) stress distributing tubes can be advanced over thetensile member 84 and positioned into the myocardial tissue. Once the stress distributing tubes are positioned, the tensile member can be tied into aknot 102 to compress the tissue region throughout the defined 3-dimensional region. The movable 146 stress distributing tubes can also comprise additional features such as flared proximal ends to abut the tissue surface to ensure hemostasis at the insertion and/or exit sites, and internal gaskets also to ensure hemostasis once a tensile member is advanced through a tube. - In the embodiments shown in
FIGS. 36E to 36H and described above, the secured 146 and movable 148 stress distributing tubes prevent excess reduction or compression in the myocardial wall thickness upon application of tension to the tensioning structure. As such, the three-dimensional cinching tensioning structure is capable of compressing the region of myocardium along the tissue surface to reverse the remodeling effect and support the tissue region without applying excess force along the plane defined by the thickness of myocardium. - The three-dimensional, cinching, tensioning structures described above also exhibit required features to ensure the appropriate amount of compression against the tissue region is applied without tearing or damaging the tissue. A simple suture defines a highly localized stress concentration; especially at the insertion and exit puncture sites capable of cutting and severely traumatizing the tissue. In addition, a simple suture does not regulate the amount of compression applied along each of the three planes defined by the three-dimensional, cinching, tensioning structures; as such the myocardial wall thickness can be dramatically and undesirably reduced upon tightening without applying the desired compressive forces.
-
FIGS. 37A to 37C show the steps of placing atensioning structure 4, such as shown inFIGS. 36E to 36H, through myocardium using the delivery system shown inFIGS. 36A to 36D. Each free end of the tensile member is placed through aholder 64 of a puncturing device and the puncturing devices are compressed inside the deployment sheath. In the minimally invasive surgical approach, it is preferred that the two puncturing devices are placed in contact with the epicardial surface as shown inFIG. 37A (or alternatively can be placed into contact with the endocardial 70 surface for catheter-based or open surgical procedures). The puncturing devices are designed to penetrate the epicardium with sharpened orbeveled tips 66 at spaced apart intervals. Prior to inserting the puncturing devices, thetensile member 84 can be placed through apledget 118 or other atraumatic surface (e.g., an ePTFE patch, polyester patch, other synthetic patch, a piece of pericardium, muscle or other tissue) to add additional support at the anchor and provide additional strain relief to the underlying tissue once the tensile member is tightened, not shown. AsFIG. 37B shows, thepuncturing devices 62 are advanced through thedeployment sheath 60 at which time they expand toward their preformed configuration channeling through myocardium to define a space for the tensile member to pass. Alternatively, thepuncturing devices 62 can pass thetensile member 84 from the epicardial surface through the myocardium, past the endocardium, along the endocardium, and back to the epicardium. Once the puncturing devices have advanced the ends of the tensile member through the heart wall and back past the epicardium, the ends of the tensile member are removed from the holder and the puncturing device is subsequently removed from the heart. The free ends of the tensile member are then tied together thereby tightening and compressing a region of the heart wall. Again, prior to tightening the free ends of the tensile member, they can also be inserted throughpledgets 118 or other atraumatic structure to provide additional support and strain relief at the tissue puncture sites.FIG. 37C shows a heart with sections cut-out and atensioning structure 4 placed through the myocardium. The solid line demarcates the tensioning structure on the surface of the heart wall or along the cut-out section of the heart wall and the dotted line demarcates the tensioning structure section positioned through a spaced away section of myocardium. The tensioning structure passes through the myocardium along two spaced apart lines thereby producing a 3-dimensional cinching mechanism capable of tightening the heart wall in three planes, (a) along the insertion line through the myocardium, (b) between the insertion points defined by the spacing between insertion points through the epicardial 68 surface and into the myocardium and between the exit points the tensioning structure traverses prior to tightening into a knot, and (c) along the myocardial wall thickness. The ratio between these tension parameters (i.e., a, b, and c above), in terms of the length of the insertion line and the spacing respectively, the stress distribution ratios defined by the secured 146 and movable 148 stress distributing tubes, and the magnitude of the tightening force applied to the tensioning structure defines the applied load to the heart tissue. This applied tensile load thereby also defines the degree of tightening of the heart wall in the axial (from the annulus to the apex), lateral, and vertical directions respectively and can be adjusted to custom tailor the reduction in volume of the infarcted/ischemic zone. Furthermore, the tension can be adjusted as required to alter the wall motion of this zone to better match that of adjacent myocardium. Also, it is noted that these tensioning structures can be oriented at other angles relative to the heart thereby defining different tensioning planes, and the tensioning planes do not have to extend perpendicular to one another. - The
tensile members 84, and secured 146 and movable 148 stress distributing tubes of tensioning structure embodiments deployed into the 3-dimensional, cinching pattern, as shown inFIGS. 36E to 36H, 37A to 37C and described above, can consist of expanded PTFE, polypropylene, urethane derivatives, silicone, nylon, polyester, biological materials (e.g., pericardial tissue formed into strips, vascular tissue such as saphenous veins maintained in tubular form or cut into strips, submucosal tissue formed into strips, or other collagen or elastin based tissue structure), genetically engineered tissue formed into strips, metals (e.g., titanium), alloys (e.g., stainless steel, nickel titanium, etc.), polymers, or other material formed into a line, strip, tube, rod, bar, or other geometry. -
FIGS. 38A to 38C show the deployment of a tensioning structure through myocardium utilizing an alternative deployment system of the invention, which is shown inFIGS. 43A to 43D. In this embodiment, a singletensile member 84 is shown deployed through the myocardium. Afterwards, anchors can be placed over the free ends of thetensile member 84 to secure both ends of said member to the tissue surface. The opposite ends of the tensile member can then be tied producing an axially oriented tightening of the tensioning structure; or one free end of the tensile member can be subsequently inserted through myocardium at a spaced apart location to produce a three-dimensional, cinching effect; or a second tensile member can be inserted at a spaced apart location with the deployment system and the free ends of the tensile member pair can be tied together in some pattern to tighten the tensioning structure and reinforce the infarcted/ischemic zone. Again, secured 146 and movable 148 stress distributing tubes can be oriented to define the ratios of compression, regulate the amount of myocardial wall thickness reduction/compression, and distribute the stress at the insertion and exit sites of the tensile member. - As shown in
FIGS. 43A to 43D this delivery system embodiment incorporates two sheaths defining different curves and apuncturing device 62. Theouter sheath 104 incorporates a beveled tip to define the initial penetration through the tissue surface. Themiddle sheath 106 incorporates a curved region and a beveled tip to tunnel through the myocardium (either partially or completely through the other tissue surface). The curved region of themiddle sheath 106 straightens as the middle sheath is retracted into the outer sheath in a coaxial arrangement. Theinner puncturing device 62 incorporates a curve to orient the distal end of the puncturing device back out of the myocardium and past the initial tissue surface at a defined distance from the initial penetration or insertion site defined by the curve of the middle sheath and the curve of the puncturing device as shown inFIG. 43D . The puncturingdevice 62 also incorporates a needle tip 66 (e.g., beveled tip, cutting tip, pointed tip, diamond tip, or other configuration) and aholder 64. Theholder 64 in this configuration is a slotted region from one side that includes a small inward protrusion to prevent the tensile member from migrating out of the slotted region once positioned. Thetensile member 84 is positioned into the holder by advancing a side of the tensile member through the slot until it is advanced past the protrusion. Removal of the tensile member can be done manually by pulling the member laterally from the slot or axially past the protrusion with forceps, needle drivers, or other surgical instrument. It should also be noted that two inner puncturing devices can alternatively be utilized with a larger middle sheath (single or dual-lumen) and a larger outer sheath to simultaneously deploy two ends of a single tensile member through tissue at spaced apart intervals or two individual tensile members through tissue at spaced apart intervals. Alternatively, three or more inner puncturing devices can be utilized with appropriately configured middle and outer sheaths to deploy more than two individual tensile members through tissue simultaneously. -
FIG. 42 illustrates an alternative, puncturing device that incorporates theholder 64 as a separate component inserted through a hole or slot in the body of thepuncturing device 62 just proximal to theneedle tip 66. Theholder 64 component of this embodiment consists of a wire wound into a shepherd's hook type or other similar geometry that can be fed through the hole or slot of the puncturing device such that it enables insertion or retraction of tensioning structures through tissue. -
FIG. 39A shows the placement of a three-dimensional, cinching, tensioning structure placed through myocardium of the left ventricle, extending from the epicardium, through myocardium, past the endocardium and back to the epicardium at a distance from the initial puncture site. It also depicts the placement of a three-dimensional, cinching pattern using tensioning structures through the myocardium of the right ventricle and extending along the endocardium of the right ventricle for a significant distance. The tensioning structures can be deployed with the systems described above to reinforce the left or right ventricle along an infarcted/ischemic zone or other weak or remodeling zones. -
FIGS. 39B and 40E show three-dimensional cinching, tensioning structures placed along themitral valve annulus 108 with one section of the tensile member (or one discrete tensile member as discussed above) placed on the leftatrial side 74 and one section (or another discrete tensile member) placed on the left ventricular side.FIG. 40E also shows a three-dimensional, cinching, tensioning structure similarly placed along the tricuspid annulus. Once tied, the tensioning structure can cinch and tighten the mitral (or tricuspid) annulus similar to the tensioning structure embodiments discussed previously. This embodiment also enables further tightening of the tensioning structure intraoperatively, during follow-up procedures, or with mechanisms remotely actuated by directly tying the knot(s) tighter or providing a mechanism to twist, retract over a spacer, or otherwise manipulate the knot or insertion end of the tensioning structure, post procedure as desired. Alternatively, the tensioning structure can also reinforce the aortic valve by deploying one or more tensioning structures and tightening, until valve insufficiencies are resolved. -
FIGS. 40A to 40D show representative three-dimensional, cinching, tensioning structure patterns capable of reinforcing infarcted and ischemic zones of the heart. Any pattern of tensioning structures can be capable of providing the desired recovery or reverse remodeling response where the tensioning structures extend between border regions of the infarcted/ischemic zones passing through the zone or extending from inside the infarcted/ischemic zone to just beyond the border regions. Also, an individual tensioning structure can pass through multiple infarcted/ischemic zones to reinforce a larger region of ventricular tissue. The flexibility of these tensioning structure and deployment system embodiments enable the physician to custom tailor the treatment options to the patient after careful analysis of the valve competency, ventricular wall motion, ejection fraction, and other diagnostic parameters.FIG. 40F shows a group of three-dimensional, cinching, tensioning structures extending around an infarcted/ischemic zone and passing from a border zone into or beyond the infarcted/ischemic zone. The free ends of this flower-shaped pattern of three-dimensional, cinching, tensioning structures can be tied together permanently or secured to a mechanism capable of twisting the knotted regions or otherwise manipulating the free ends to adjust or tighten the tensioning structures intraoperatively, during a follow-up procedure, or remotely post procedure. Again, these adjustments can facilitate chronic maintenance of positive hemodynamic conditions. -
FIG. 41A shows a three-dimensional, cinching, tensioning structure incorporating two insertion and exit points along the axial plane. Again, secured 146 and movable 148 stress distributing tubes can be oriented along the tensile member, especially proximate to the various insertion and exit sites. In these tensioning structure embodiments, the tightening force is distributed at more than two locations (i.e.,the insertion and knotted sites) thereby ensuring that a long, tightening structure will be capable of reinforcing tissue midway between the ends of the three-dimensional, cinching, tensioning structure. It is also noted that more than two, inline loops (as shown inFIG. 41A ) can be utilized for the three-dimensional cinching tensioning structures. - In
FIG. 41B , a three-dimensional, cinching, tensioning structure oriented in a dual-loop shaped configuration surrounded by a similar tensioning structure oriented in a shield-shaped configuration. The tensile member passes through and above thetissue 112 at the center of the configuration. Together, the two patterns apply tightening forces laterally and apically to the heart to reinforce the infarcted/ischemic zone and restore a more desirable wall motion to the heart. -
FIG. 41C shows an alternative tensioning structure pattern that spirals around the infarcted/ischemic zone from the border region to the center of the zone. The free ends of this structure can be tightened to compress the zone inward towards the middle. The spiral pattern can be also be adjusted to take into account the different degrees of motion laterally versus apically by altering the length versus width ratio of the spiral pattern, the spacing between entry and exit points, and the spacing between each concentric ring of the pattern. -
FIGS. 41D and 41E show a top view and a side-sectional, close-up view of anothertensioning structure 4 embodiment that comprisestensile members 84 attached to radiallyextensible anchors 32 at each end. Thetensioning structures 4 extend from within the infarct/ischemic region 20 to outside the border zone and also incorporateanchors 32 placed into or through myocardium. The proximal ends of each of the various tensile members are attached to acentral hub 158 positioned on the external surface of the heart configured so that it can be tightened at or about thishub 158. The close up view of the anchor inFIG. 41E illustrates the outwardly expanded extensions placed against the endocardial (or epicardial) surface to lock the attachedtensile member 84 to the heart. It is also noted that these tensioning structures can also comprise secured 146 and movable 148 stress distributing tubes as described above. -
FIGS. 41F and 41G show a perspective view of a heart with a three-dimensional, cinching, myocardial tensioning structure embodiment incorporating an automatic, knot-locking anchor mechanism to variably tighten the free ends of thetensile member 84.FIG. 41F shows thetensioning structure 4 with theknot anchor 150 engaging thetensile members 84, but not completely tightened.FIG. 41G shows themyocardial tensioning structure 4 with theknot anchor 150 tightened over the free ends of thetensile member 84.FIG. 41H shows a close-up, cross-sectional view of theknot anchor 150 inFIGS. 41F and 41G . A ratcheting extension orjaw 152 allows movement of thetensile member 84 in one direction, but prevents movement or migration of the tensile member in the opposite direction.FIG. 41I also depicts a close-up, cross-sectional view of an alternative, knot anchor embodiment with one end of thetensile member 84 attached and the other end movable relative to the ratcheting extension orjaw 152. In this embodiment and as withFIGS. 41F and 41G , the knot anchor also incorporates aratchet mechanism jaw 152 that enables thetensile member 84 to pass in one direction through asidewall exit hole 172, but prevents migration in the opposite direction allowing it to act as alocking mechanism 168. These knot anchor embodiments permit remote tightening and adjustment of thetensioning structure 4 once positioned to enable gradual tightening over a period of time to maximize and maintain the reverse remodeling effects. - Also seen in
FIG. 41I is theanchoring loop 156. A formedtube 160 captures theanchoring loop 156. This tube is formed around theanchoring loop 156 such that an interference is created resulting in a mechanical joint between the components. This along with the ratcheting mechanism orjaw 152 is encapsulated by another tube to create a proximal anchor with a ratcheting capability. This embodiment is ideally suited for constriction of the valve annulus. -
FIGS. 44A and 44B show a tensioning structure embodiment that incorporates a tensile member secured to a self-expanding (or plastically deformable) anchor as described above in the Intravascular Conduit Tensioning Structures and Cardiac Valve Annulus Tensioning Structures sections of this specification. Both anchor ends of a tensioning structure are compressed into a low profile within the lumen of a delivery sheath, similar toFIG. 43A , incorporating a beveled tip to puncture through tissue. A single sheath can be used to insert both anchors of the tensioning structure into or through myocardium, or each anchor can be compressed into individual sheaths.FIG. 44A shows a heart with sections cut away containing a deployed anchor extending through the myocardium and incorporating radial extensions engaging the endocardial surface. In this figure, a tensioning member is shown attached to the deployed anchor formation with the opposite end of the same tensioning member shown secured to an anchor compressed inside a sheath for deployment through the myocardium and into the left ventricular cavity. Once the sheath accesses the anchoring site, a stylet is used to advance the anchor beyond the confines of the constraining sheath where the anchor is allowed to expand into its preformed or radially expanded configuration. Then, the anchor can be retracted into engagement with the endocardial surface as shown inFIG. 44B with application of tension to the tensile member. At this point, the tensile member can be further tightened by creating a knot or by twisting to increase the applied force as required. It should be noted that the anchors can be placed into the myocardium such that the extensions lock to myocardial tissue without extending beyond the endocardial surface. The sheath used to deploy the anchors of the tensioning structure can incorporate a slot for the tensioning member to pass thereby preventing slack along the tensile member that is tightened by forming a knot or other tying mechanism. It is therefore noted that individual tensioning structures containing an anchor only at one end while the opposite end remains free can be deployed and secured using the deployment system previously described and the free ends can be tied together to tighten the tensioning structures to produce the desired volume reduction, reinforcement or other compressive response. -
FIG. 44C shows additional features to the tensioning structure described above wherepledgets 118 or other similar atraumatic interfaces mentioned elsewhere in this specification are positioned at each insertion point of the anchor through the epicardial surface to provide strain relief and to prevent abrasion or other unwanted effect of tightening of the tensile member against tissue. Apledget 118 or other atraumatic interface can also be placed under the knot used to tighten the tensioning structure. In addition, it is also noted that the tensioning structures can comprise secured 146 and movable 148 stress distributing tubes, as described above, at the insertion or exit sites, along the myocardial wall, or elsewhere along the tensile member(s). - The tensioning structures and incorporated anchors can alternatively be inserted from the endocardial surface into myocardium or through myocardium such that the anchors contact the epicardial surface during surgical or catheter-based approaches, as shown in
FIGS. 45A and 45B . One or more sheaths can be used to deploy the two anchors and the tensile member into the heart. Thebase 114 of such endocardial anchors can be configured withmarker bands 36 in this approach. - A guiding catheter, as shown in
FIG. 45C , covers the beveled deployment sheath and is used to cross the aorta during a retrograde procedure, or the mitral valve during a trans-septal procedure or a surgical procedure accessing the left ventricular cavity from the left atrial appendage or atrial free wall. The deployment sheath is then advanced relative to the guiding sheath, as shown inFIG. 45D , and is used to puncture the endocardial surface to access the myocardium. The anchor can then be expelled by advancing a stylet or retracting the deployment sheath while maintaining the position of the stylet, as shown inFIG. 45E . The anchor is inserted within the myocardium or further manipulated through the myocardium, past the epicardial surface, and into the pericardial space where it expands towards its preformed configuration and is engaged against the epicardial surface, as shown inFIG. 45A . -
FIGS. 45F to 45H show this anchor embodiment expanding towards its preformed enlarged, radially expanded configuration. Alternatively, a balloon or other expansion mechanism can be used to plastically deform the anchor into an enlarged orientation. The engagement pins 130 are biased outward to contact myocardium or the epicardial surface (or endocardial surface for surgical approaches described above) and prevent retraction of the anchor once positioned. As shown inFIGS. 45F to 45H, thetensile member 84 is secured to thebase 114 of the anchor preferably such that maximum outer diameter of thetensile member 84 is greater than the cross-sectional diameter of thebase 114 of the anchor to ensure hemostasis through the channel created through the myocardium once the anchor is inserted and secured in place. In this embodiment, thetensile member 84 covers the entire cross-section of thebase 114 of theanchor 32. Alternatively, the tensile member can be secured to one side of the base and have a diameter smaller than the outside diameter of thebase 114. It should be noted that the deployment system and anchor embodiments shown inFIGS. 45C to 45H are directly applicable to the surgical process described forFIGS. 44A to 44C above. -
FIGS. 45I to 45L show analternative anchor member 32 well suited for use as a myocardial tensioning structure embodiment.FIG. 45I shows a tube of anchor material (e.g., nickel titanium, titanium, stainless steel, superelastic polymer, or other such anchor material previously described) cut into a pattern ofextensions 132 emanating from thedistal end 132 of the anchor, and a base 114 to which thetensile member 84 is attached. The base 114 (and distal end 132) can be fabricated as expandable/compressible to enable expansion or compressing the anchor during or after deployment.FIG. 45J shows the process of thermal forming theanchor extensions 116 into a radially expanded orientation.FIGS. 45K and 45L show a perspective view and a side view of theanchor 32 with atensile member 84 attached to the interior surface of the anchor from thedistal end 132 to thebase 114. As described inFIGS. 45F to 45H above, thetensile member 84 can alternatively be attached beyond the exterior surface of thebase 114. - In addition, the anchor embodiments shown in
FIGS. 45F to 45L can be utilized as an anchor that engages the coronary sinus orifice when inserting the tensioning structure intravascularly within the coronary sinus for tightening and reinforcing the valve annulus as described in the Cardiac Valve Annulus Tensioning Structures section above. These anchor embodiments can also be inserted through valve leaflets to reposition the valves upon applying tension via the tensioning structure, as described in the Chordae Tendineae and Valve Leaflet Tensioning Structures section below. - A single sheath incorporating two stylets having different profiles to accommodate different diameter anchors or anchors incorporating features enabling sequential deployment of the first anchor prior to actuation of the second anchor can be used to deploy the tensioning structure during catheter-based procedures. Once the first anchor is positioned and engaged into tissue, the second can be positioned and deployed. The final result of such an approach is illustrated in
FIG. 45B . -
FIGS. 46A to 46M show an alternative, integrated tensioning structure embodiment where thetensile member 84 incorporates features to enable anchoring and a preformed geometry having sufficient column strength to be directed through myocardium without the need for the deployment sheath to puncture tissue to insert the tensile member and/or anchor. As shown inFIGS. 46A and 46B , the tensioning structure is constrained into a low profile inside a blunt tip deployment sheath. This tensioning structure embodiment is preferably fabricated from a superelastic alloy (e.g., nickel titanium), other alloy (e.g., stainless steel), or metal (e.g., titanium) incorporating an elastic component and a preformed geometry. As shown inFIGS. 46E through 46F , the tensioning structure itself is used to puncture the epicardial surface (or endocardial surface for catheter-based approaches) and channel through the myocardium. As the tensioning structure is further advanced beyond the confines of the blunt deployment sheath, as shown inFIG. 46G , the tensioning structure returns towards it preformed or expanded shape directing the free end of the tensioning structure back up towards and past the epicardial (or endocardial) surface. This tensioning structure embodiment consists of a stiff tensile member formed into a “U” shape with sharpfree ends 120 to penetrate tissue. Each of the free ends 120 is inserted through the tissue surface at spaced apart intervals such that once positioned the looped or flat end of the “U” shape can be used to anchor the tensioning structure at one end. As described previously, secured 146 or movable 148 stress distributing tubes can be used as required at this end to dampen the trauma and regulate application of the compressive forces by the tensioning structure against the tissue surface. As shown inFIGS. 46H through 46K , aseparate locking anchor 124 can be secured to the free ends of the tensioning structure intonotches 122 or other mating features in thetensioning structure 4 to define and maintain the applied tension and to prevent migration. The anchor can consist of a tube, bar, or sheet containing openings and a ratchet mechanism that allows the sharp ends of the tensioning structure to enter while preventing separation once placed, as shown inFIG. 46K .FIGS. 46L and 46M show an illustrated placement of this tensioning structure embodiment after deployment and after locking with the anchor component, respectively. As with all of the 3-dimensional, cinching, tensioning structures described previously, this clip-like tensioning structure embodiment can traverse in any direction around the infarcted/ischemic zone and multiple clip-like tensioning structures can be inserted and secured throughout the infarcted/ischemic zones to custom tailor the reinforcement profile to the patients needs. -
FIGS. 46N to 46P show additional delivery system features for deploying these integrated 3-dimensional, cinching, tensioning structures.FIG. 46N shows the deployment sheath with a flared,distal end 134 to provide strain relief during puncture, andFIGS. 46O and 46P show expandable/compressible extensions associated with the deployment sheath to enable low profile entry into the body, to stabilize and provide a surface to leverage the deployment sheath during puncture preventing inadvertent insertion of the sheath through the heart's surface. An outer constrainingtube 138 is used to compress theextensions 136 during deployment through ports into the chest cavity or other less invasive access. Alternatively, the extensions can be fabricated rigid, especially for invasive surgical approaches such as a median sternotomy. -
FIGS. 46Q to 46Y show alternative integrated, 3-dimensional, cinching,tensioning structures 4 of the invention. Thesetensioning structures 4 incorporate spring mechanisms at the loop anchors 96 and anchor lock springs 144 to further custom tailor the cinching forces applied by the tensioning structure to the heart tissue. These spring mechanisms can comprise a helix, a sinusoid, open cells, or other expandable and compressible mechanisms. As shown inFIG. 46X , anchor lock holes 142 can be incorporated in the distal end of thetensile member 84 to enable locking the anchor lock springs 144 to thetensile member 84 to define the attachedtensioning structure 4. - The three-dimensional, cinching, tensioning structure in
FIGS. 46S to 46Y further incorporates astraightening lumen 140 through which a stylet can be inserted to orient thetensile member 84 for deployment into or through myocardium. As the stylet (not shown) is advanced through thestraightening lumen 140, the tensile member straightens for insertion into or through myocardium. As the stylet is retracted or the tensile member is advanced beyond the end of the stylet, the tensile member reverts back towards its preformed, curved shape channeling through tissue and defining the deployed configuration. Once deployed, the stylet is removed leaving the tensile member to be locked with theanchor spring 144. - Chordae Tendineae & Valve Leaflet Tensioning Structures
- As mentioned before, the tensioning structures of the invention by also be used to apply tension to papillary muscles and/or chordae tendineae to reposition the valve leaflets to reduce/eliminate regurgitation, to limit the motion of the leaflets to improve/restore the function of cardiac valves; and to directly reposition the valve leaflets to prevent prolapse or other abnormalities of the leaflets and to prevent associated deficiencies. In this spirit,
FIGS. 47A to 47D show a tensioning structure embodiment and delivery system used to place the tensioning structure from the epicardium through the myocardium, around one or more chordae tendineae or through a papillary muscle, and back through the myocardium where the tensioning structure is anchored such that it applies tension to these sub-valvular structures to reorient the valve leaflets and restrict valve prolapse.FIGS. 47A to 47C show the three-component delivery system fromFIGS. 43A to 43D passing one or more tensioning structures through or around thechordae tendineae 110, or through or around a papillary muscle. The delivery system locates the free ends of the tensioning structures through myocardium and external to the endocardium where they can be tied to tighten the tensioning structures. As shown inFIG. 47A , the outer sheath is inserted through the heart wall. The outer sheath can incorporate a beveled tip as shown inFIG. 43A or can be inserted over a trocar, needle, or other penetrating mechanism. The middle sheath is then advanced through the outer sheath as shown inFIG. 47B . In this version, the middle sheath does not require a beveled or sharpened tip and it is preferred that the distal end is atraumatic so the middle sheath does not damage the chordae tendineae as it is advanced through the outer sheath where it is allowed to expand towards its preformed, curved configuration passing around chordae tendineae. If the middle sheath needs to pass through papillary muscles then it would require a beveled or sharpened tip to puncture the papillary muscle. Alternatively, the sheath can incorporate a steering mechanism to manually curve the sheath around the papillary muscle or chordae tendineae instead of relying upon a self-expanding preformed shape. Once positioned, as shown inFIG. 47C , the puncturing device is inserted through the middle sheath and is used to pass thetensioning structure 4 through the middle sheath and back through the endocardium, through the myocardium and past the epicardium where it can be removed from the holder with forceps or other similar instrument. Then as shown inFIG. 47D , the deployment system is removed and the tensioning structure is tightened. The degree of tightening can be guided or adjusted based on Transesophageal Echocardiography, Intracardiac Echocardiography, MRI, Fluoroscopy, CT, or other imaging or visualization modality capable of determining the apposition and movement of the valve leaflets. -
FIGS. 48A and 48B show an alternative tensioning structure and associated delivery system used to engage a chordae tendineae or papillary muscle with one end while the opposite end produces an anchor that is capable of tightening to apply tension to the chordae tendineae orpapillary muscles 128. As shown inFIGS. 49A, 49B , 50A and 50B, thedistal anchor 32 of the tensioning structure is advanced through the myocardium and is entangled to thechordae tendineae 110 orpapillary muscle 128, and the proximal end is then pulled through the epicardial surface and expanded (plastically deformable) or allowed to expand (superelastic) into a preformed, enlarged shape preventing migration of theproximal anchor 32 into the heart cavity. At this point the amount of tension applied to the chordae tendineae or papillary muscle depends on the placement of the proximal anchor and the length of thetensile member 84 between these anchors. The tension can then be altered utilizing a variably tightening mechanism as described above or by relocating theproximal anchor 32 to increase or decrease tension as required. - The tensioning structures, such as those shown in
FIGS. 45F to 45L, can alternatively be inserted through the valve leaflets as opposed to around or through the papillary muscle or chordae tendineae to directly reposition the valve leaflets by tightening the tensioning structures from the epicardial surface of the heart. In this configuration, a grasping instrument containing a lumen providing passage for the puncturing device can be used to temporarily engage the valve leaflet and provide a path to advance the tensioning structure past the epicardial surface, through the myocardium, up to and through the valve leaflet. Then the anchor is deployed (by balloon expansion or release of a self-expanding anchor) against the valve leaflet thereby attaching thetensile member 84. The proximal end of the tensile member is then retracted past the epicardial surface and the desired amount of tension to reposition or stabilize the valve leaflet is applied based upon real-time assessment/visualization of hemodynamics and anatomic motion. Finally, the proximal end of thetensile member 84 is anchored to the epicardial surface at a suitable location. Alternatively, the delivery system used to engage the valve leaflet can provide a mechanism to grasp thetensile member 84 after insertion of the tensile member through the valve leaflet. Such a mechanism would enable retraction back past the myocardium and epicardium so that the opposite free ends of thetensile member 84 can be tied, tightened and used to manipulate the position of the valve leaflets, thereby defining the tensioning structure. Alternatively, the leaflets may be directly manipulated and repositioned using the mechanism inFIGS. 51A and 51B . This mechanism facilitates grasping and then locking onto the leaflet tissue by engaging thejaw 152 with ananchor cincher tube 150. Furthermore, the mechanism could be attached to a tensile member and anchor to facilitate locating and securing the structure at the desired position to urge valve competency. - Tensioning Structure Materials and General Fabrication Methods
- The embodiments of the entire invention described herein can be fabricated from various biological, metallic, and polymeric materials. For self-expanding components of the embodiments, those components are preferably fabricated from a superelastic, shape memory material like nitinol (nickel titanium alloy). These types of materials elastically deform upon exposure to an external force and return to their preformed shape upon reduction or removal of the external force. This elasticity property renders the material as ideal for deployment with vascular conduit target about eccentric, three-dimensional tortuous geometries with limited concern toward fatigue failure and difficulty in placement. Superelastic shape memory alloys also enable straining of the material numerous times without plastic deformation. The repetitive strain capability facilitates a limited systolic stretch to enable adequate cardiac output while limiting or restricting the possibility of over stretch and continuation of the cyclic damage.
- Various components of the tensioning structures can be fabricated from shape memory alloys (e.g., nickel titanium) demonstrating stress-induced martensite at ambient temperature. Other shape memory alloys can be used and the superelastic material can alternatively exhibit austenite properties at ambient temperature. The composition of the shape memory alloy is preferably chosen to produce the finish and start martensite transformation temperatures (Mf and Ms) and the start and finish austenite transformation temperatures (As and Af) depending on the desired material response. When fabricating shape memory alloys that exhibit stress induced martensite the material composition is chosen such that the maximum temperature that the material exhibits stress-induced martensite properties (Md) is greater than Af and the range of temperatures between Af and Md covers the range of ambient temperatures to which the support members are exposed. When fabricating shape memory alloys that exhibit austenite properties and do not transform to martensite in response to stress, the material composition is chosen such that both Af and Md are less than the range of temperatures to which the supports are exposed. Of course, Af and Md can be chosen at any temperatures provided the shape memory alloy exhibits superelastic properties throughout the temperature range to which they are exposed. Nickel titanium having an atomic ratio of 51.2% Ni to 48.8% Ti exhibits an Af of approximately −20° C.; nickel titanium having an atomic ratio of 50% Ni to 50% Ti exhibits an Af of approximately 100° C. [Melzer A, Pelton A. Superelastic Shape-Memory Technology of Nitinol in Medicine. Min Invas Ther & Allied Technol. 2000: 9(2) 59-60].
- Such superelastic components are able to withstand strain as high as 10% without plastically deforming. Materials other than superelastic shape memory alloys can replace superelastic materials in appropriate tensioning structure components provided they can be elastically deformed within the temperature, stress, and strain parameters required to maximize the elastic restoring force, thereby enabling the tensioning structures to exert a directional force in response to an induced deflection. Such materials include other shape memory alloys, bulk metallic glasses, amorphous Beryllium, suitable ceramic compositions, spring stainless steel 17-7, Elgiloy™, superelastic polymers, etc.
- The tensioning structures are expected to be of limited thrombogenicity and with percutaneous deployment especially in venous structures of the heart, the risk of infarct, adverse cerebral embolic events and other similar ischemic events/injury is severely limited if not avoided. Also, administration of commonly used anti-clotting and anti-platelet pharmacological agents is generally restricted to the implant procedure and not required in an ongoing basis.
- The tensioning structures can be fabricated from at least one rod, wire, suture, strand, strip, band, bar, tube, sheet, ribbon or other such raw material having the desired pattern, cross sectional profile, dimensions, or a combination of cross-sections. These raw materials can be formed from various standard means including but not limited to: extrusion, injection molding, press-forging, rotary forging, bar rolling, sheet rolling, cold drawing, cold rolling, using multiple cold working and annealing steps, or casting. When using superelastic materials or other alloys as the tensioning structures, they can be cut into the desired pattern and thermally formed into the desired three-dimensional geometric form. The tensioning structures can then be cut into the desired length, pattern or other geometric form using various means including, but not limited to, conventional abrasive sawing, water jet cutting, laser cutting, EDM machining, photochemical etching or other etching techniques. The addition of holes, slots, notches and other cut away areas on the support structure body facilitates the capability to tailor the stiffness of the implant.
- The tensioning structure components, especially those that employ the use of tubular or wire raw materials, can also be further modified via centerless grinding means to enable tensioning structures that are tapered (i.e.,have a cross-sectional diameter on the proximal end of the structure that progressively ramps down to a smaller cross-section on the opposite or distal end). Tensioning structure components of this type of geometry are ideally suited for placement in the vascular conduits since said anatomical conduits tend to taper in a similar fashion from the proximal ostia down to distal locations.
- The tensioning structure components can be fabricated from a multitude of these individually processed or unprocessed components (rods, wires, bands, bars, tubes, sheets, ribbons, etc.) and joined together using various means including but not limited to the following: laser welding, adhesive bonding, soldering, spot welding, mechanical crimping, swaging and other attachment means to produce composite tensioning structures.
- When fabricating superelastic tensioning structure components from tubing, the raw material can have an oval, circular, rectangular, square, trapezoidal, or other cross-sectional geometry capable of being cut into the desired pattern. After cutting the desired pattern, the tensioning structure components are formed into the desired shape, heated, for example, between 300° C. and 600° C., and allowed to cool in the preformed geometry to set the shape of the support members.
- When fabricating superelastic tensioning structure components from flat sheets of raw material, the raw material can be configured with at least one width, W, and at least one wall thickness, T, throughout the raw material. As such, the raw sheet material can have a consistent wall thickness, a tapered thickness, or sections of varying thickness. The raw material is then cut into the desired pattern, and thermally shaped into the desired three-dimensional geometry. Opposite ends or intersections of thermally formed tensioning structure components can be secured by using shrink tubing, applying adhesives, welding, soldering, mechanically engaging, utilizing another bonding means or a combination of these bonding methods. Opposite ends of the thermally formed tensioning structure components can alternatively be free-floating to permit increased flexibility.
- Once superelastic tensioning structure components are fabricated and formed into the desired three-dimensional geometry, the supports can be electropolished, tumbled, sand blasted, chemically etched, ground, or otherwise treated to remove any edges and/or produce a smooth surface.
- The previous discussions provide description of minimally invasive and percutaneous tensioning structures and delivery devices used to treat degenerative heart disease in patients suffering any stage of congestive heart failure. In addition, the described inventions provide a methods and devices to provide restriction of continued enlargement of the heart, potentially progressively reduce heart size via reverse remodeling (i.e.,application of compressive force during both systole and diastole) and finally decrease valvular regurgitation associated with said enlargement.
- It will be obvious to those skilled in the art that the support structures described herein can be applied across a broad spectrum of organ structures to provide reinforcement and to limit enlargement facilitated by compensatory physiologic mechanisms.
- Though the invention has been described in reference to certain examples, optionally incorporating various features, the invention is not to be limited to the set-ups described. The invention is not limited to the uses noted or by way of the exemplary description provided herein. Numerous modifications and/or additions to the above-described embodiments would be readily apparent to one skilled in the art; it is intended that the scope of the present inventions extend to all such modifications and/or additions. It is to be understood that the breadth of the present invention is to be limited only by the literal or equitable scope of the following claims. That being said,
Claims (19)
1-50. (canceled)
51. An intravascular mitral valve support system comprising:
a proximal anchor, a distal anchor and an elongate member secured between the proximal and distal anchors,
the elongate member including a spring section,
at least the distal anchor being adapted for receipt within a coronary sinus vessel,
the system being adapted to exert force on the mitral valve when the elongate member is tensioned against the anchors.
52. The system of claim 51 , wherein the elongate member comprises a wire.
53. The system of claim 51 , wherein the wire is selected from stainless steel, NiTi and titanium alloy.
54. The system of claim 51 , wherein at least one of said anchors comprises a structure selected from a single hook, multiple hooks, a stent, a helix, a loop and a disk.
55. The system of claim 51 , wherein at least the distal anchor is adapted to hold against the coronary sinus lumen.
56. The system of claim 54 , wherein the proximal anchor is adapted to hold against the coronary sinus lumen.
57. The system of claim 51 , wherein the proximal anchor is adapted to hold at an ostium of the coronary sinus.
58. The system of claim 51 , wherein the spring section includes a plurality of switchbacks.
59. The system of claim 51 , comprising a detent mechanism to selectively alter spring performance.
60. The system of claim 51 , wherein the spring section is shaped in waves.
61. The system of claim 60 , comprising a ratchet member interfacing with the spring waves to alter spring performance.
62. The system of claim 51 , wherein the spring section is spiral or helical shaped.
63. The system of claim 62 , further comprising a plurality of loops to engage portions of the spring section.
64. The system of claim 51 , further comprising a plurality of loops to engage portions of the spring section.
65. The system of claim 64 , wherein the loop comprises suture material, ribbon or wire.
66. The system of claim 65 , wherein release of the loops relaxes the spring section.
67. The system of claim 51 , wherein the system is adapted for intraoperative tension adjustment.
68. The device of claim 51 , wherein the system is adapted for postoperative tension adjustment.
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Cited By (91)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20030236569A1 (en) * | 2002-01-30 | 2003-12-25 | Cardiac Dimensions, Inc. | Device and method for modifying the shape of a body organ |
US20040133240A1 (en) * | 2003-01-07 | 2004-07-08 | Cardiac Dimensions, Inc. | Electrotherapy system, device, and method for treatment of cardiac valve dysfunction |
US20040220657A1 (en) * | 2003-05-02 | 2004-11-04 | Cardiac Dimensions, Inc., A Washington Corporation | Tissue shaping device with conformable anchors |
US20050015109A1 (en) * | 2003-07-16 | 2005-01-20 | Samuel Lichtenstein | Methods and devices for altering blood flow through the left ventricle |
US20060030882A1 (en) * | 2002-03-06 | 2006-02-09 | Adams John M | Transvenous staples, assembly and method for mitral valve repair |
US20060173536A1 (en) * | 2002-05-08 | 2006-08-03 | Mathis Mark L | Body lumen device anchor, device and assembly |
US20070208357A1 (en) * | 1999-06-25 | 2007-09-06 | Houser Russell A | Apparatus and methods for treating tissue |
US20080015466A1 (en) * | 2006-07-13 | 2008-01-17 | Mayo Foundation For Medical Education And Research | Obtaining a tissue sample |
US20080065185A1 (en) * | 2006-09-10 | 2008-03-13 | Seth Worley | Pacing lead and method for pacing in the pericardial space |
US20080167705A1 (en) * | 2007-01-10 | 2008-07-10 | Cook Incorporated | Short wire stent delivery system with splittable outer sheath |
US20080293996A1 (en) * | 2006-02-06 | 2008-11-27 | Evans Michael A | Systems and methods for volume reduction |
US20090177259A1 (en) * | 2008-01-03 | 2009-07-09 | Bacchus Vascular, Inc. | Methods and systems for placement of a stent adjacent an ostium |
US7666224B2 (en) | 2002-11-12 | 2010-02-23 | Edwards Lifesciences Llc | Devices and methods for heart valve treatment |
US7670368B2 (en) | 2005-02-07 | 2010-03-02 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US7674287B2 (en) | 2001-12-05 | 2010-03-09 | Cardiac Dimensions, Inc. | Device and method for modifying the shape of a body organ |
US7678145B2 (en) | 2002-01-09 | 2010-03-16 | Edwards Lifesciences Llc | Devices and methods for heart valve treatment |
US7682385B2 (en) | 2002-04-03 | 2010-03-23 | Boston Scientific Corporation | Artificial valve |
US20100094401A1 (en) * | 2008-10-10 | 2010-04-15 | William Cook Europe, Aps | Curvable stent-graft and apparatus and fitting method |
US7722666B2 (en) | 2005-04-15 | 2010-05-25 | Boston Scientific Scimed, Inc. | Valve apparatus, system and method |
US7749249B2 (en) | 2006-02-21 | 2010-07-06 | Kardium Inc. | Method and device for closing holes in tissue |
US7758639B2 (en) | 2003-02-03 | 2010-07-20 | Cardiac Dimensions, Inc. | Mitral valve device using conditioned shape memory alloy |
US7766812B2 (en) | 2000-10-06 | 2010-08-03 | Edwards Lifesciences Llc | Methods and devices for improving mitral valve function |
US7776053B2 (en) | 2000-10-26 | 2010-08-17 | Boston Scientific Scimed, Inc. | Implantable valve system |
US7780722B2 (en) | 2005-02-07 | 2010-08-24 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US7780627B2 (en) | 2002-12-30 | 2010-08-24 | Boston Scientific Scimed, Inc. | Valve treatment catheter and methods |
US7794496B2 (en) | 2003-12-19 | 2010-09-14 | Cardiac Dimensions, Inc. | Tissue shaping device with integral connector and crimp |
US7799038B2 (en) | 2006-01-20 | 2010-09-21 | Boston Scientific Scimed, Inc. | Translumenal apparatus, system, and method |
US7828842B2 (en) | 2002-01-30 | 2010-11-09 | Cardiac Dimensions, Inc. | Tissue shaping device |
US7828841B2 (en) | 2002-05-08 | 2010-11-09 | Cardiac Dimensions, Inc. | Device and method for modifying the shape of a body organ |
US7837729B2 (en) | 2002-12-05 | 2010-11-23 | Cardiac Dimensions, Inc. | Percutaneous mitral valve annuloplasty delivery system |
US7837728B2 (en) | 2003-12-19 | 2010-11-23 | Cardiac Dimensions, Inc. | Reduced length tissue shaping device |
US7837610B2 (en) | 2006-08-02 | 2010-11-23 | Kardium Inc. | System for improving diastolic dysfunction |
US7854761B2 (en) | 2003-12-19 | 2010-12-21 | Boston Scientific Scimed, Inc. | Methods for venous valve replacement with a catheter |
US7854755B2 (en) | 2005-02-01 | 2010-12-21 | Boston Scientific Scimed, Inc. | Vascular catheter, system, and method |
US7878966B2 (en) | 2005-02-04 | 2011-02-01 | Boston Scientific Scimed, Inc. | Ventricular assist and support device |
US7883539B2 (en) | 1997-01-02 | 2011-02-08 | Edwards Lifesciences Llc | Heart wall tension reduction apparatus and method |
US7887582B2 (en) | 2003-06-05 | 2011-02-15 | Cardiac Dimensions, Inc. | Device and method for modifying the shape of a body organ |
US7892276B2 (en) | 2007-12-21 | 2011-02-22 | Boston Scientific Scimed, Inc. | Valve with delayed leaflet deployment |
US20110106012A1 (en) * | 2009-10-29 | 2011-05-05 | Velarde Franz E | Sheath Introducer with Self-Anchoring Mechanism |
US7951189B2 (en) | 2005-09-21 | 2011-05-31 | Boston Scientific Scimed, Inc. | Venous valve, system, and method with sinus pocket |
US7967853B2 (en) | 2007-02-05 | 2011-06-28 | Boston Scientific Scimed, Inc. | Percutaneous valve, system and method |
US7976539B2 (en) | 2004-03-05 | 2011-07-12 | Hansen Medical, Inc. | System and method for denaturing and fixing collagenous tissue |
US8002824B2 (en) | 2004-09-02 | 2011-08-23 | Boston Scientific Scimed, Inc. | Cardiac valve, system, and method |
US8006594B2 (en) | 2008-08-11 | 2011-08-30 | Cardiac Dimensions, Inc. | Catheter cutting tool |
US8012198B2 (en) | 2005-06-10 | 2011-09-06 | Boston Scientific Scimed, Inc. | Venous valve, system, and method |
US8075608B2 (en) | 2002-12-05 | 2011-12-13 | Cardiac Dimensions, Inc. | Medical device delivery system |
US8128681B2 (en) | 2003-12-19 | 2012-03-06 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US8133270B2 (en) | 2007-01-08 | 2012-03-13 | California Institute Of Technology | In-situ formation of a valve |
US8150499B2 (en) | 2006-05-19 | 2012-04-03 | Kardium Inc. | Automatic atherectomy system |
US8226711B2 (en) | 1997-12-17 | 2012-07-24 | Edwards Lifesciences, Llc | Valve to myocardium tension members device and method |
US8439971B2 (en) | 2001-11-01 | 2013-05-14 | Cardiac Dimensions, Inc. | Adjustable height focal tissue deflector |
US8449605B2 (en) | 2006-06-28 | 2013-05-28 | Kardium Inc. | Method for anchoring a mitral valve |
US8489172B2 (en) | 2008-01-25 | 2013-07-16 | Kardium Inc. | Liposuction system |
US8545551B2 (en) | 2005-11-23 | 2013-10-01 | Hansen Medical, Inc. | Methods, devices, and kits for treating mitral valve prolapse |
US8828079B2 (en) | 2007-07-26 | 2014-09-09 | Boston Scientific Scimed, Inc. | Circulatory valve, system and method |
US8906011B2 (en) | 2007-11-16 | 2014-12-09 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US8920411B2 (en) | 2006-06-28 | 2014-12-30 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US8940002B2 (en) | 2010-09-30 | 2015-01-27 | Kardium Inc. | Tissue anchor system |
US20150030499A1 (en) * | 2013-07-24 | 2015-01-29 | Injectinator, LLC | System and method for carpet-odor treatment |
US9011423B2 (en) | 2012-05-21 | 2015-04-21 | Kardium, Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US9050066B2 (en) | 2010-06-07 | 2015-06-09 | Kardium Inc. | Closing openings in anatomical tissue |
US9072511B2 (en) | 2011-03-25 | 2015-07-07 | Kardium Inc. | Medical kit for constricting tissue or a bodily orifice, for example, a mitral valve |
US9119633B2 (en) | 2006-06-28 | 2015-09-01 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US9198592B2 (en) | 2012-05-21 | 2015-12-01 | Kardium Inc. | Systems and methods for activating transducers |
US9204964B2 (en) | 2009-10-01 | 2015-12-08 | Kardium Inc. | Medical device, kit and method for constricting tissue or a bodily orifice, for example, a mitral valve |
US9370419B2 (en) | 2005-02-23 | 2016-06-21 | Boston Scientific Scimed, Inc. | Valve apparatus, system and method |
US9452016B2 (en) | 2011-01-21 | 2016-09-27 | Kardium Inc. | Catheter system |
US9480525B2 (en) | 2011-01-21 | 2016-11-01 | Kardium, Inc. | High-density electrode-based medical device system |
US9492227B2 (en) | 2011-01-21 | 2016-11-15 | Kardium Inc. | Enhanced medical device for use in bodily cavities, for example an atrium |
US9526616B2 (en) | 2003-12-19 | 2016-12-27 | Cardiac Dimensions Pty. Ltd. | Mitral valve annuloplasty device with twisted anchor |
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US9622859B2 (en) | 2005-02-01 | 2017-04-18 | Boston Scientific Scimed, Inc. | Filter system and method |
US9668859B2 (en) | 2011-08-05 | 2017-06-06 | California Institute Of Technology | Percutaneous heart valve delivery systems |
US9744037B2 (en) | 2013-03-15 | 2017-08-29 | California Institute Of Technology | Handle mechanism and functionality for repositioning and retrieval of transcatheter heart valves |
US9744038B2 (en) | 2008-05-13 | 2017-08-29 | Kardium Inc. | Medical device for constricting tissue or a bodily orifice, for example a mitral valve |
US10028783B2 (en) | 2006-06-28 | 2018-07-24 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US10368936B2 (en) | 2014-11-17 | 2019-08-06 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US10390953B2 (en) | 2017-03-08 | 2019-08-27 | Cardiac Dimensions Pty. Ltd. | Methods and devices for reducing paravalvular leakage |
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US10722184B2 (en) | 2014-11-17 | 2020-07-28 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US10827977B2 (en) | 2012-05-21 | 2020-11-10 | Kardium Inc. | Systems and methods for activating transducers |
US11026791B2 (en) | 2018-03-20 | 2021-06-08 | Medtronic Vascular, Inc. | Flexible canopy valve repair systems and methods of use |
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US11259867B2 (en) | 2011-01-21 | 2022-03-01 | Kardium Inc. | High-density electrode-based medical device system |
US11285003B2 (en) | 2018-03-20 | 2022-03-29 | Medtronic Vascular, Inc. | Prolapse prevention device and methods of use thereof |
US11285005B2 (en) | 2006-07-17 | 2022-03-29 | Cardiac Dimensions Pty. Ltd. | Mitral valve annuloplasty device with twisted anchor |
US11311380B2 (en) | 2003-05-02 | 2022-04-26 | Cardiac Dimensions Pty. Ltd. | Device and method for modifying the shape of a body organ |
US11389232B2 (en) | 2006-06-28 | 2022-07-19 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US11596771B2 (en) | 2020-12-14 | 2023-03-07 | Cardiac Dimensions Pty. Ltd. | Modular pre-loaded medical implants and delivery systems |
US11766331B2 (en) | 2020-05-27 | 2023-09-26 | Politecnico Di Milano | Device and assembly to repair a heart valve |
Families Citing this family (470)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6050936A (en) | 1997-01-02 | 2000-04-18 | Myocor, Inc. | Heart wall tension reduction apparatus |
ES2335252T3 (en) * | 1997-06-27 | 2010-03-23 | The Trustees Of Columbia University In The City Of New York | APPARATUS FOR THE REPAIR OF VALVES OF THE CIRCULATORY SYSTEM. |
FR2768324B1 (en) | 1997-09-12 | 1999-12-10 | Jacques Seguin | SURGICAL INSTRUMENT FOR PERCUTANEOUSLY FIXING TWO AREAS OF SOFT TISSUE, NORMALLY MUTUALLY REMOTE, TO ONE ANOTHER |
US7491232B2 (en) | 1998-09-18 | 2009-02-17 | Aptus Endosystems, Inc. | Catheter-based fastener implantation apparatus and methods with implantation force resolution |
US6260552B1 (en) | 1998-07-29 | 2001-07-17 | Myocor, Inc. | Transventricular implant tools and devices |
US20040044350A1 (en) | 1999-04-09 | 2004-03-04 | Evalve, Inc. | Steerable access sheath and methods of use |
EP2078498B1 (en) | 1999-04-09 | 2010-12-22 | Evalve, Inc. | Apparatus for cardiac valve repair |
US8216256B2 (en) | 1999-04-09 | 2012-07-10 | Evalve, Inc. | Detachment mechanism for implantable fixation devices |
US7811296B2 (en) | 1999-04-09 | 2010-10-12 | Evalve, Inc. | Fixation devices for variation in engagement of tissue |
US10327743B2 (en) | 1999-04-09 | 2019-06-25 | Evalve, Inc. | Device and methods for endoscopic annuloplasty |
US7226467B2 (en) | 1999-04-09 | 2007-06-05 | Evalve, Inc. | Fixation device delivery catheter, systems and methods of use |
US6752813B2 (en) | 1999-04-09 | 2004-06-22 | Evalve, Inc. | Methods and devices for capturing and fixing leaflets in valve repair |
SE514718C2 (en) * | 1999-06-29 | 2001-04-09 | Jan Otto Solem | Apparatus for treating defective closure of the mitral valve apparatus |
US6997951B2 (en) | 1999-06-30 | 2006-02-14 | Edwards Lifesciences Ag | Method and device for treatment of mitral insufficiency |
US8500795B2 (en) | 1999-08-09 | 2013-08-06 | Cardiokinetix, Inc. | Retrievable devices for improving cardiac function |
US7674222B2 (en) * | 1999-08-09 | 2010-03-09 | Cardiokinetix, Inc. | Cardiac device and methods of use thereof |
US9694121B2 (en) | 1999-08-09 | 2017-07-04 | Cardiokinetix, Inc. | Systems and methods for improving cardiac function |
US8388672B2 (en) | 1999-08-09 | 2013-03-05 | Cardiokinetix, Inc. | System for improving cardiac function by sealing a partitioning membrane within a ventricle |
US20030109770A1 (en) | 1999-08-09 | 2003-06-12 | Sharkey Hugh R. | Device with a porous membrane for improving cardiac function |
US8529430B2 (en) | 2002-08-01 | 2013-09-10 | Cardiokinetix, Inc. | Therapeutic methods and devices following myocardial infarction |
US7582051B2 (en) | 2005-06-10 | 2009-09-01 | Cardiokinetix, Inc. | Peripheral seal for a ventricular partitioning device |
US10307147B2 (en) | 1999-08-09 | 2019-06-04 | Edwards Lifesciences Corporation | System for improving cardiac function by sealing a partitioning membrane within a ventricle |
US8257428B2 (en) | 1999-08-09 | 2012-09-04 | Cardiokinetix, Inc. | System for improving cardiac function |
EP1113497A3 (en) * | 1999-12-29 | 2006-01-25 | Texas Instruments Incorporated | Semiconductor package with conductor impedance selected during assembly |
US8758400B2 (en) | 2000-01-05 | 2014-06-24 | Integrated Vascular Systems, Inc. | Closure system and methods of use |
US7011682B2 (en) * | 2000-01-31 | 2006-03-14 | Edwards Lifesciences Ag | Methods and apparatus for remodeling an extravascular tissue structure |
US6989028B2 (en) * | 2000-01-31 | 2006-01-24 | Edwards Lifesciences Ag | Medical system and method for remodeling an extravascular tissue structure |
US9332992B2 (en) | 2004-08-05 | 2016-05-10 | Cardiokinetix, Inc. | Method for making a laminar ventricular partitioning device |
US10064696B2 (en) | 2000-08-09 | 2018-09-04 | Edwards Lifesciences Corporation | Devices and methods for delivering an endocardial device |
US9332993B2 (en) | 2004-08-05 | 2016-05-10 | Cardiokinetix, Inc. | Devices and methods for delivering an endocardial device |
US8398537B2 (en) | 2005-06-10 | 2013-03-19 | Cardiokinetix, Inc. | Peripheral seal for a ventricular partitioning device |
US20060030881A1 (en) * | 2004-08-05 | 2006-02-09 | Cardiokinetix, Inc. | Ventricular partitioning device |
US7862500B2 (en) | 2002-08-01 | 2011-01-04 | Cardiokinetix, Inc. | Multiple partitioning devices for heart treatment |
US9078660B2 (en) | 2000-08-09 | 2015-07-14 | Cardiokinetix, Inc. | Devices and methods for delivering an endocardial device |
US7762943B2 (en) | 2004-03-03 | 2010-07-27 | Cardiokinetix, Inc. | Inflatable ventricular partitioning device |
JP2004506469A (en) | 2000-08-18 | 2004-03-04 | アトリテック, インコーポレイテッド | Expandable implantable device for filtering blood flow from the atrial appendage |
US8956407B2 (en) * | 2000-09-20 | 2015-02-17 | Mvrx, Inc. | Methods for reshaping a heart valve annulus using a tensioning implant |
US20060106278A1 (en) * | 2004-05-14 | 2006-05-18 | Ample Medical, Inc. | Devices, systems, and methods for reshaping a heart valve annulus, including the use of an adjustable bridge implant system |
US8784482B2 (en) * | 2000-09-20 | 2014-07-22 | Mvrx, Inc. | Method of reshaping a heart valve annulus using an intravascular device |
US20090287179A1 (en) | 2003-10-01 | 2009-11-19 | Ample Medical, Inc. | Devices, systems, and methods for reshaping a heart valve annulus, including the use of magnetic tools |
US7691144B2 (en) | 2003-10-01 | 2010-04-06 | Mvrx, Inc. | Devices, systems, and methods for reshaping a heart valve annulus |
US20080091264A1 (en) | 2002-11-26 | 2008-04-17 | Ample Medical, Inc. | Devices, systems, and methods for reshaping a heart valve annulus, including the use of magnetic tools |
US8690910B2 (en) | 2000-12-07 | 2014-04-08 | Integrated Vascular Systems, Inc. | Closure device and methods for making and using them |
US7591826B2 (en) * | 2000-12-28 | 2009-09-22 | Cardiac Dimensions, Inc. | Device implantable in the coronary sinus to provide mitral valve therapy |
US7510576B2 (en) * | 2001-01-30 | 2009-03-31 | Edwards Lifesciences Ag | Transluminal mitral annuloplasty |
US20050125011A1 (en) * | 2001-04-24 | 2005-06-09 | Spence Paul A. | Tissue fastening systems and methods utilizing magnetic guidance |
US8202315B2 (en) | 2001-04-24 | 2012-06-19 | Mitralign, Inc. | Catheter-based annuloplasty using ventricularly positioned catheter |
US6800090B2 (en) * | 2001-05-14 | 2004-10-05 | Cardiac Dimensions, Inc. | Mitral valve therapy device, system and method |
US6676702B2 (en) * | 2001-05-14 | 2004-01-13 | Cardiac Dimensions, Inc. | Mitral valve therapy assembly and method |
US7144363B2 (en) * | 2001-10-16 | 2006-12-05 | Extensia Medical, Inc. | Systems for heart treatment |
US6949122B2 (en) * | 2001-11-01 | 2005-09-27 | Cardiac Dimensions, Inc. | Focused compression mitral valve device and method |
US6575971B2 (en) | 2001-11-15 | 2003-06-10 | Quantum Cor, Inc. | Cardiac valve leaflet stapler device and methods thereof |
US20110087320A1 (en) * | 2001-11-28 | 2011-04-14 | Aptus Endosystems, Inc. | Devices, Systems, and Methods for Prosthesis Delivery and Implantation, Including a Prosthesis Assembly |
CA2464048C (en) | 2001-11-28 | 2010-06-15 | Lee Bolduc | Endovascular aneurysm repair system |
US9320503B2 (en) | 2001-11-28 | 2016-04-26 | Medtronic Vascular, Inc. | Devices, system, and methods for guiding an operative tool into an interior body region |
US20090099650A1 (en) * | 2001-11-28 | 2009-04-16 | Lee Bolduc | Devices, systems, and methods for endovascular staple and/or prosthesis delivery and implantation |
US20050177180A1 (en) * | 2001-11-28 | 2005-08-11 | Aptus Endosystems, Inc. | Devices, systems, and methods for supporting tissue and/or structures within a hollow body organ |
US20070073389A1 (en) * | 2001-11-28 | 2007-03-29 | Aptus Endosystems, Inc. | Endovascular aneurysm devices, systems, and methods |
US8231639B2 (en) | 2001-11-28 | 2012-07-31 | Aptus Endosystems, Inc. | Systems and methods for attaching a prosthesis within a body lumen or hollow organ |
US6908478B2 (en) | 2001-12-05 | 2005-06-21 | Cardiac Dimensions, Inc. | Anchor and pull mitral valve device and method |
US6793673B2 (en) | 2002-12-26 | 2004-09-21 | Cardiac Dimensions, Inc. | System and method to effect mitral valve annulus of a heart |
EP1458313B1 (en) * | 2001-12-28 | 2010-03-31 | Edwards Lifesciences AG | Delayed memory device |
US20050209690A1 (en) * | 2002-01-30 | 2005-09-22 | Mathis Mark L | Body lumen shaping device with cardiac leads |
US6960229B2 (en) * | 2002-01-30 | 2005-11-01 | Cardiac Dimensions, Inc. | Device and method for modifying the shape of a body organ |
US6749621B2 (en) | 2002-02-21 | 2004-06-15 | Integrated Vascular Systems, Inc. | Sheath apparatus and methods for delivering a closure device |
US6797001B2 (en) | 2002-03-11 | 2004-09-28 | Cardiac Dimensions, Inc. | Device, assembly and method for mitral valve repair |
US7758637B2 (en) * | 2003-02-06 | 2010-07-20 | Guided Delivery Systems, Inc. | Delivery devices and methods for heart valve repair |
US20050107811A1 (en) * | 2002-06-13 | 2005-05-19 | Guided Delivery Systems, Inc. | Delivery devices and methods for heart valve repair |
US6986775B2 (en) * | 2002-06-13 | 2006-01-17 | Guided Delivery Systems, Inc. | Devices and methods for heart valve repair |
US7666193B2 (en) * | 2002-06-13 | 2010-02-23 | Guided Delivery Sytems, Inc. | Delivery devices and methods for heart valve repair |
US8287555B2 (en) * | 2003-02-06 | 2012-10-16 | Guided Delivery Systems, Inc. | Devices and methods for heart valve repair |
US7753858B2 (en) * | 2002-06-13 | 2010-07-13 | Guided Delivery Systems, Inc. | Delivery devices and methods for heart valve repair |
US20050216078A1 (en) * | 2002-06-13 | 2005-09-29 | Guided Delivery Systems, Inc. | Delivery devices and methods for heart valve repair |
US8641727B2 (en) | 2002-06-13 | 2014-02-04 | Guided Delivery Systems, Inc. | Devices and methods for heart valve repair |
US7883538B2 (en) | 2002-06-13 | 2011-02-08 | Guided Delivery Systems Inc. | Methods and devices for termination |
US20040243227A1 (en) * | 2002-06-13 | 2004-12-02 | Guided Delivery Systems, Inc. | Delivery devices and methods for heart valve repair |
US20060122633A1 (en) | 2002-06-13 | 2006-06-08 | John To | Methods and devices for termination |
US7588582B2 (en) * | 2002-06-13 | 2009-09-15 | Guided Delivery Systems Inc. | Methods for remodeling cardiac tissue |
US7753922B2 (en) * | 2003-09-04 | 2010-07-13 | Guided Delivery Systems, Inc. | Devices and methods for cardiac annulus stabilization and treatment |
US9949829B2 (en) | 2002-06-13 | 2018-04-24 | Ancora Heart, Inc. | Delivery devices and methods for heart valve repair |
US7572257B2 (en) | 2002-06-14 | 2009-08-11 | Ncontact Surgical, Inc. | Vacuum coagulation and dissection probes |
US7063698B2 (en) | 2002-06-14 | 2006-06-20 | Ncontact Surgical, Inc. | Vacuum coagulation probes |
US9439714B2 (en) | 2003-04-29 | 2016-09-13 | Atricure, Inc. | Vacuum coagulation probes |
US8235990B2 (en) | 2002-06-14 | 2012-08-07 | Ncontact Surgical, Inc. | Vacuum coagulation probes |
US6893442B2 (en) | 2002-06-14 | 2005-05-17 | Ablatrics, Inc. | Vacuum coagulation probe for atrial fibrillation treatment |
US7040323B1 (en) * | 2002-08-08 | 2006-05-09 | Tini Alloy Company | Thin film intrauterine device |
AU2003277118A1 (en) * | 2002-10-01 | 2004-04-23 | Ample Medical, Inc. | Devices for retaining native heart valve leaflet |
US20040133062A1 (en) * | 2002-10-11 | 2004-07-08 | Suresh Pai | Minimally invasive cardiac force transfer structures |
US7087064B1 (en) * | 2002-10-15 | 2006-08-08 | Advanced Cardiovascular Systems, Inc. | Apparatuses and methods for heart valve repair |
US20050119735A1 (en) | 2002-10-21 | 2005-06-02 | Spence Paul A. | Tissue fastening systems and methods utilizing magnetic guidance |
JP2006503651A (en) | 2002-10-21 | 2006-02-02 | ミトラリグン・インコーポレーテッド | Method and apparatus for performing catheter-based annuloplasty surgery using plication |
US7485143B2 (en) * | 2002-11-15 | 2009-02-03 | Abbott Cardiovascular Systems Inc. | Apparatuses and methods for heart valve repair |
US7335213B1 (en) | 2002-11-15 | 2008-02-26 | Abbott Cardiovascular Systems Inc. | Apparatus and methods for heart valve repair |
US7981152B1 (en) | 2004-12-10 | 2011-07-19 | Advanced Cardiovascular Systems, Inc. | Vascular delivery system for accessing and delivering devices into coronary sinus and other vascular sites |
US9149602B2 (en) | 2005-04-22 | 2015-10-06 | Advanced Cardiovascular Systems, Inc. | Dual needle delivery system |
US7404824B1 (en) | 2002-11-15 | 2008-07-29 | Advanced Cardiovascular Systems, Inc. | Valve aptation assist device |
US8187324B2 (en) | 2002-11-15 | 2012-05-29 | Advanced Cardiovascular Systems, Inc. | Telescoping apparatus for delivering and adjusting a medical device in a vessel |
US7776042B2 (en) | 2002-12-03 | 2010-08-17 | Trans1 Inc. | Methods and apparatus for provision of therapy to adjacent motion segments |
US20040158321A1 (en) * | 2003-02-12 | 2004-08-12 | Cardiac Dimensions, Inc. | Method of implanting a mitral valve therapy device |
US20040254600A1 (en) * | 2003-02-26 | 2004-12-16 | David Zarbatany | Methods and devices for endovascular mitral valve correction from the left coronary sinus |
US20060161169A1 (en) * | 2003-05-02 | 2006-07-20 | Cardiac Dimensions, Inc., A Delaware Corporation | Device and method for modifying the shape of a body organ |
US10667823B2 (en) | 2003-05-19 | 2020-06-02 | Evalve, Inc. | Fixation devices, systems and methods for engaging tissue |
US7351259B2 (en) * | 2003-06-05 | 2008-04-01 | Cardiac Dimensions, Inc. | Device, system and method to affect the mitral valve annulus of a heart |
US8052751B2 (en) * | 2003-07-02 | 2011-11-08 | Flexcor, Inc. | Annuloplasty rings for repairing cardiac valves |
EP1646332B1 (en) | 2003-07-18 | 2015-06-17 | Edwards Lifesciences AG | Remotely activated mitral annuloplasty system |
IES20030539A2 (en) * | 2003-07-22 | 2005-05-18 | Medtronic Vascular Connaught | Stents and stent delivery system |
US7860579B2 (en) * | 2003-07-25 | 2010-12-28 | Integrated Sensing Systems, Inc. | Delivery system, method, and anchor for medical implant placement |
US7534204B2 (en) * | 2003-09-03 | 2009-05-19 | Guided Delivery Systems, Inc. | Cardiac visualization devices and methods |
US7998112B2 (en) | 2003-09-30 | 2011-08-16 | Abbott Cardiovascular Systems Inc. | Deflectable catheter assembly and method of making same |
US7004176B2 (en) * | 2003-10-17 | 2006-02-28 | Edwards Lifesciences Ag | Heart valve leaflet locator |
US20060184242A1 (en) * | 2003-10-20 | 2006-08-17 | Samuel Lichtenstein | Method and apparatus for percutaneous reduction of anterior-posterior diameter of mitral valve |
EP2305155A3 (en) * | 2003-10-23 | 2015-01-14 | TRANS1, Inc. | Tools and tool kits for performing minimally invasive procedures on the spine |
US20060276684A1 (en) * | 2003-11-07 | 2006-12-07 | Giovanni Speziali | Device and method for treating congestive heart failure |
US20050187620A1 (en) * | 2003-11-14 | 2005-08-25 | Suresh Pai | Systems for heart treatment |
AU2004298762A1 (en) * | 2003-12-16 | 2005-06-30 | Edwards Lifesciences Ag | Device for changing the shape of the mitral annulus |
US20050177228A1 (en) * | 2003-12-16 | 2005-08-11 | Solem Jan O. | Device for changing the shape of the mitral annulus |
US20050273138A1 (en) * | 2003-12-19 | 2005-12-08 | Guided Delivery Systems, Inc. | Devices and methods for anchoring tissue |
US20050137449A1 (en) * | 2003-12-19 | 2005-06-23 | Cardiac Dimensions, Inc. | Tissue shaping device with self-expanding anchors |
US20050137450A1 (en) * | 2003-12-19 | 2005-06-23 | Cardiac Dimensions, Inc., A Washington Corporation | Tapered connector for tissue shaping device |
US20060271174A1 (en) * | 2003-12-19 | 2006-11-30 | Gregory Nieminen | Mitral Valve Annuloplasty Device with Wide Anchor |
US8828078B2 (en) | 2003-12-23 | 2014-09-09 | Sadra Medical, Inc. | Methods and apparatus for endovascular heart valve replacement comprising tissue grasping elements |
US9526609B2 (en) | 2003-12-23 | 2016-12-27 | Boston Scientific Scimed, Inc. | Methods and apparatus for endovascularly replacing a patient's heart valve |
US7381219B2 (en) | 2003-12-23 | 2008-06-03 | Sadra Medical, Inc. | Low profile heart valve and delivery system |
US7445631B2 (en) | 2003-12-23 | 2008-11-04 | Sadra Medical, Inc. | Methods and apparatus for endovascularly replacing a patient's heart valve |
US7329279B2 (en) | 2003-12-23 | 2008-02-12 | Sadra Medical, Inc. | Methods and apparatus for endovascularly replacing a patient's heart valve |
US8864822B2 (en) * | 2003-12-23 | 2014-10-21 | Mitralign, Inc. | Devices and methods for introducing elements into tissue |
US7959666B2 (en) | 2003-12-23 | 2011-06-14 | Sadra Medical, Inc. | Methods and apparatus for endovascularly replacing a heart valve |
US8343213B2 (en) | 2003-12-23 | 2013-01-01 | Sadra Medical, Inc. | Leaflet engagement elements and methods for use thereof |
US7824443B2 (en) * | 2003-12-23 | 2010-11-02 | Sadra Medical, Inc. | Medical implant delivery and deployment tool |
US9005273B2 (en) | 2003-12-23 | 2015-04-14 | Sadra Medical, Inc. | Assessing the location and performance of replacement heart valves |
US20120041550A1 (en) | 2003-12-23 | 2012-02-16 | Sadra Medical, Inc. | Methods and Apparatus for Endovascular Heart Valve Replacement Comprising Tissue Grasping Elements |
US11278398B2 (en) | 2003-12-23 | 2022-03-22 | Boston Scientific Scimed, Inc. | Methods and apparatus for endovascular heart valve replacement comprising tissue grasping elements |
US7824442B2 (en) | 2003-12-23 | 2010-11-02 | Sadra Medical, Inc. | Methods and apparatus for endovascularly replacing a heart valve |
US20050137687A1 (en) | 2003-12-23 | 2005-06-23 | Sadra Medical | Heart valve anchor and method |
US8840663B2 (en) | 2003-12-23 | 2014-09-23 | Sadra Medical, Inc. | Repositionable heart valve method |
US8603160B2 (en) | 2003-12-23 | 2013-12-10 | Sadra Medical, Inc. | Method of using a retrievable heart valve anchor with a sheath |
US7748389B2 (en) | 2003-12-23 | 2010-07-06 | Sadra Medical, Inc. | Leaflet engagement elements and methods for use thereof |
US8182528B2 (en) | 2003-12-23 | 2012-05-22 | Sadra Medical, Inc. | Locking heart valve anchor |
US8287584B2 (en) | 2005-11-14 | 2012-10-16 | Sadra Medical, Inc. | Medical implant deployment tool |
US7166127B2 (en) | 2003-12-23 | 2007-01-23 | Mitralign, Inc. | Tissue fastening systems and methods utilizing magnetic guidance |
US20050137694A1 (en) | 2003-12-23 | 2005-06-23 | Haug Ulrich R. | Methods and apparatus for endovascularly replacing a patient's heart valve |
US8579962B2 (en) | 2003-12-23 | 2013-11-12 | Sadra Medical, Inc. | Methods and apparatus for performing valvuloplasty |
US7780725B2 (en) | 2004-06-16 | 2010-08-24 | Sadra Medical, Inc. | Everting heart valve |
CN101947146B (en) | 2003-12-23 | 2014-08-06 | 萨德拉医学公司 | Relocatable heart valve |
US7993397B2 (en) * | 2004-04-05 | 2011-08-09 | Edwards Lifesciences Ag | Remotely adjustable coronary sinus implant |
US8545414B2 (en) * | 2004-04-30 | 2013-10-01 | St. Jude Medical, Cardiology Division, Inc. | Methods and devices for modulation of heart valve function |
US7632361B2 (en) * | 2004-05-06 | 2009-12-15 | Tini Alloy Company | Single crystal shape memory alloy devices and methods |
EP3398522B1 (en) | 2004-05-14 | 2019-12-25 | Evalve, Inc. | Locking mechanisms for fixation devices |
DE102004027461A1 (en) * | 2004-06-04 | 2005-12-22 | Bip Gmbh | Marker for insertion into human or animal tissue, to mark a site of interest, has elastic wing loops which expand when pushed out of the magazine to anchor the marker in the tissue material |
US20060004388A1 (en) * | 2004-06-18 | 2006-01-05 | Ablatrics, Inc. | System for tissue cavity closure |
US7361190B2 (en) | 2004-06-29 | 2008-04-22 | Micardia Corporation | Adjustable cardiac valve implant with coupling mechanism |
US7731650B2 (en) * | 2004-06-30 | 2010-06-08 | Ethicon, Inc. | Magnetic capture and placement for cardiac assist device |
US20060004249A1 (en) * | 2004-06-30 | 2006-01-05 | Ethicon Incorporated | Systems and methods for sizing cardiac assist device |
US7601117B2 (en) * | 2004-06-30 | 2009-10-13 | Ethicon, Inc. | Systems and methods for assisting cardiac valve coaptation |
EP1793745B2 (en) | 2004-09-27 | 2022-03-16 | Evalve, Inc. | Devices for tissue grasping and assessment |
US8052592B2 (en) | 2005-09-27 | 2011-11-08 | Evalve, Inc. | Methods and devices for tissue grasping and assessment |
US20060118210A1 (en) * | 2004-10-04 | 2006-06-08 | Johnson A D | Portable energy storage devices and methods |
WO2006041877A2 (en) * | 2004-10-05 | 2006-04-20 | Ample Medical, Inc. | Atrioventricular valve annulus repair systems and methods including retro-chordal anchors |
US7211110B2 (en) * | 2004-12-09 | 2007-05-01 | Edwards Lifesciences Corporation | Diagnostic kit to assist with heart valve annulus adjustment |
DE102005003632A1 (en) | 2005-01-20 | 2006-08-17 | Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. | Catheter for the transvascular implantation of heart valve prostheses |
WO2011034628A1 (en) | 2005-02-07 | 2011-03-24 | Evalve, Inc. | Methods, systems and devices for cardiac valve repair |
WO2006086434A1 (en) | 2005-02-07 | 2006-08-17 | Evalve, Inc. | Methods, systems and devices for cardiac valve repair |
US8096303B2 (en) | 2005-02-08 | 2012-01-17 | Koninklijke Philips Electronics N.V | Airway implants and methods and devices for insertion and retrieval |
US8371307B2 (en) | 2005-02-08 | 2013-02-12 | Koninklijke Philips Electronics N.V. | Methods and devices for the treatment of airway obstruction, sleep apnea and snoring |
US20060207612A1 (en) | 2005-02-08 | 2006-09-21 | Jasper Jackson | Tissue anchoring system for percutaneous glossoplasty |
WO2006097931A2 (en) | 2005-03-17 | 2006-09-21 | Valtech Cardio, Ltd. | Mitral valve treatment techniques |
US10219902B2 (en) | 2005-03-25 | 2019-03-05 | Mvrx, Inc. | Devices, systems, and methods for reshaping a heart valve anulus, including the use of a bridge implant having an adjustable bridge stop |
US7763342B2 (en) * | 2005-03-31 | 2010-07-27 | Tini Alloy Company | Tear-resistant thin film methods of fabrication |
US7357815B2 (en) * | 2005-04-21 | 2008-04-15 | Micardia Corporation | Dynamically adjustable implants and methods for reshaping tissue |
US8333777B2 (en) | 2005-04-22 | 2012-12-18 | Benvenue Medical, Inc. | Catheter-based tissue remodeling devices and methods |
US7962208B2 (en) | 2005-04-25 | 2011-06-14 | Cardiac Pacemakers, Inc. | Method and apparatus for pacing during revascularization |
US20060253193A1 (en) * | 2005-05-03 | 2006-11-09 | Lichtenstein Samuel V | Mechanical means for controlling blood pressure |
US20060264367A1 (en) * | 2005-05-21 | 2006-11-23 | Howard Florey Institute | Prevention of fibrosis following cardiac injury |
US7500989B2 (en) * | 2005-06-03 | 2009-03-10 | Edwards Lifesciences Corp. | Devices and methods for percutaneous repair of the mitral valve via the coronary sinus |
WO2006133186A2 (en) * | 2005-06-07 | 2006-12-14 | The International Heart Institute Of Montana Foundation | A system, including method and apparatus for percutaneous endovascular treatment of functional mitral valve insufficiency |
US8951285B2 (en) | 2005-07-05 | 2015-02-10 | Mitralign, Inc. | Tissue anchor, anchoring system and methods of using the same |
US20070055206A1 (en) * | 2005-08-10 | 2007-03-08 | Guided Delivery Systems, Inc. | Methods and devices for deployment of tissue anchors |
US20070038297A1 (en) * | 2005-08-12 | 2007-02-15 | Bobo Donald E Jr | Medical implant with reinforcement mechanism |
US20080221673A1 (en) * | 2005-08-12 | 2008-09-11 | Donald Bobo | Medical implant with reinforcement mechanism |
US9492277B2 (en) * | 2005-08-30 | 2016-11-15 | Mayo Foundation For Medical Education And Research | Soft body tissue remodeling methods and apparatus |
US20070055368A1 (en) * | 2005-09-07 | 2007-03-08 | Richard Rhee | Slotted annuloplasty ring |
WO2007030823A2 (en) * | 2005-09-09 | 2007-03-15 | Edwards Lifesciences Corporation | Device and method for reshaping mitral valve annulus |
US7712606B2 (en) | 2005-09-13 | 2010-05-11 | Sadra Medical, Inc. | Two-part package for medical implant |
US20070073391A1 (en) * | 2005-09-28 | 2007-03-29 | Henry Bourang | System and method for delivering a mitral valve repair device |
US8211011B2 (en) | 2006-11-09 | 2012-07-03 | Ncontact Surgical, Inc. | Diaphragm entry for posterior surgical access |
US8721597B2 (en) * | 2006-11-09 | 2014-05-13 | Ncontact Surgical, Inc. | Diaphragm entry for posterior surgical access |
US10433859B2 (en) | 2005-10-12 | 2019-10-08 | Atricure, Inc. | Diaphragm entry for posterior surgical access |
US9808280B2 (en) | 2005-10-12 | 2017-11-07 | Atricure, Inc. | Diaphragm entry for posterior surgical access |
CN101466316B (en) | 2005-10-20 | 2012-06-27 | 阿普特斯内系统公司 | Devices systems and methods for prosthesis delivery and implantation including the use of a fastener tool |
US8043368B2 (en) * | 2005-11-23 | 2011-10-25 | Traves Dean Crabtree | Methods and apparatus for atrioventricular valve repair |
WO2007067820A2 (en) * | 2005-12-09 | 2007-06-14 | Edwards Lifesciences Corporation | Improved anchoring system for medical implant |
US10039531B2 (en) * | 2005-12-15 | 2018-08-07 | Georgia Tech Research Corporation | Systems and methods to control the dimension of a heart valve |
US20070213813A1 (en) | 2005-12-22 | 2007-09-13 | Symetis Sa | Stent-valves for valve replacement and associated methods and systems for surgery |
US20070173924A1 (en) * | 2006-01-23 | 2007-07-26 | Daniel Gelbart | Axially-elongating stent and method of deployment |
US7637946B2 (en) * | 2006-02-09 | 2009-12-29 | Edwards Lifesciences Corporation | Coiled implant for mitral valve repair |
CN101415379B (en) | 2006-02-14 | 2012-06-20 | 萨德拉医学公司 | Systems for delivering a medical implant |
US20070203391A1 (en) * | 2006-02-24 | 2007-08-30 | Medtronic Vascular, Inc. | System for Treating Mitral Valve Regurgitation |
US7431692B2 (en) * | 2006-03-09 | 2008-10-07 | Edwards Lifesciences Corporation | Apparatus, system, and method for applying and adjusting a tensioning element to a hollow body organ |
US20070255317A1 (en) | 2006-03-22 | 2007-11-01 | Fanton Gary S | Suture passer devices and uses thereof |
US20070246233A1 (en) * | 2006-04-04 | 2007-10-25 | Johnson A D | Thermal actuator for fire protection sprinkler head |
US7503932B2 (en) * | 2006-04-11 | 2009-03-17 | Cardiac Dimensions, Inc. | Mitral valve annuloplasty device with vena cava anchor |
US20070244556A1 (en) * | 2006-04-12 | 2007-10-18 | Medtronic Vascular, Inc. | Annuloplasty Device Having a Helical Anchor and Methods for its Use |
WO2007136532A2 (en) * | 2006-05-03 | 2007-11-29 | St. Jude Medical, Inc. | Soft body tissue remodeling methods and apparatus |
US20070276444A1 (en) * | 2006-05-24 | 2007-11-29 | Daniel Gelbart | Self-powered leadless pacemaker |
US20070287879A1 (en) * | 2006-06-13 | 2007-12-13 | Daniel Gelbart | Mechanical means for controlling blood pressure |
US20070293904A1 (en) * | 2006-06-20 | 2007-12-20 | Daniel Gelbart | Self-powered resonant leadless pacemaker |
US8556930B2 (en) | 2006-06-28 | 2013-10-15 | Abbott Laboratories | Vessel closure device |
US7877142B2 (en) * | 2006-07-05 | 2011-01-25 | Micardia Corporation | Methods and systems for cardiac remodeling via resynchronization |
WO2008012839A1 (en) * | 2006-07-24 | 2008-01-31 | Carlo Antona | Kit for performing subcommissuroplasty during aortic valve reconstruction |
US20080065205A1 (en) * | 2006-09-11 | 2008-03-13 | Duy Nguyen | Retrievable implant and method for treatment of mitral regurgitation |
US20080075557A1 (en) * | 2006-09-22 | 2008-03-27 | Johnson A David | Constant load bolt |
US20080213062A1 (en) * | 2006-09-22 | 2008-09-04 | Tini Alloy Company | Constant load fastener |
US8029556B2 (en) * | 2006-10-04 | 2011-10-04 | Edwards Lifesciences Corporation | Method and apparatus for reshaping a ventricle |
US7854849B2 (en) * | 2006-10-10 | 2010-12-21 | Multiphase Systems Integration | Compact multiphase inline bulk water separation method and system for hydrocarbon production |
US8388680B2 (en) | 2006-10-18 | 2013-03-05 | Guided Delivery Systems, Inc. | Methods and devices for catheter advancement and delivery of substances therethrough |
US9943409B2 (en) | 2006-11-14 | 2018-04-17 | The United States Of America, As Represented By The Secretary, Department Of Health And Human Services | Transcatheter coronary sinus mitral valve annuloplasty procedure and coronary artery and myocardial protection device |
EP2091465B1 (en) | 2006-11-14 | 2018-01-31 | The Government of the United States of America as represented by the Secretary of the Department of Health and Human Services | Coronary artery and myocardial protection device |
US8349099B1 (en) | 2006-12-01 | 2013-01-08 | Ormco Corporation | Method of alloying reactive components |
US8926695B2 (en) * | 2006-12-05 | 2015-01-06 | Valtech Cardio, Ltd. | Segmented ring placement |
US9883943B2 (en) | 2006-12-05 | 2018-02-06 | Valtech Cardio, Ltd. | Implantation of repair devices in the heart |
US11259924B2 (en) | 2006-12-05 | 2022-03-01 | Valtech Cardio Ltd. | Implantation of repair devices in the heart |
US8584767B2 (en) * | 2007-01-25 | 2013-11-19 | Tini Alloy Company | Sprinkler valve with active actuation |
US8684101B2 (en) * | 2007-01-25 | 2014-04-01 | Tini Alloy Company | Frangible shape memory alloy fire sprinkler valve actuator |
US11660190B2 (en) | 2007-03-13 | 2023-05-30 | Edwards Lifesciences Corporation | Tissue anchors, systems and methods, and devices |
US8911461B2 (en) | 2007-03-13 | 2014-12-16 | Mitralign, Inc. | Suture cutter and method of cutting suture |
US20080228265A1 (en) * | 2007-03-13 | 2008-09-18 | Mitralign, Inc. | Tissue anchors, systems and methods, and devices |
US7896915B2 (en) | 2007-04-13 | 2011-03-01 | Jenavalve Technology, Inc. | Medical device for treating a heart valve insufficiency |
US20080255447A1 (en) * | 2007-04-16 | 2008-10-16 | Henry Bourang | Diagnostic catheter |
WO2009009371A2 (en) * | 2007-07-06 | 2009-01-15 | The General Hospital Corporation | System and method for intraventricular treatment |
WO2009018289A2 (en) | 2007-07-30 | 2009-02-05 | Tini Alloy Company | Method and devices for preventing restenosis in cardiovascular stents |
US8100820B2 (en) * | 2007-08-22 | 2012-01-24 | Edwards Lifesciences Corporation | Implantable device for treatment of ventricular dilation |
EP2197362B1 (en) * | 2007-08-24 | 2016-01-06 | C2M Medical, Inc. | Bone anchor comprising a shape memory element |
US20090076597A1 (en) * | 2007-09-19 | 2009-03-19 | Jonathan Micheal Dahlgren | System for mechanical adjustment of medical implants |
WO2009052427A1 (en) * | 2007-10-19 | 2009-04-23 | Guided Delivery Systems Inc. | Systems and methods for cardiac remodeling |
WO2009073609A1 (en) | 2007-11-30 | 2009-06-11 | Tini Alloy Company | Biocompatible copper-based single-crystal shape memory alloys |
US20090143713A1 (en) | 2007-11-30 | 2009-06-04 | Jacques Van Dam | Biliary Shunts, Delivery Systems, Methods of Using the Same and Kits Therefor |
US8382917B2 (en) | 2007-12-03 | 2013-02-26 | Ormco Corporation | Hyperelastic shape setting devices and fabrication methods |
US7842143B2 (en) * | 2007-12-03 | 2010-11-30 | Tini Alloy Company | Hyperelastic shape setting devices and fabrication methods |
EP2240110A4 (en) * | 2008-01-29 | 2015-07-01 | Superdimension Ltd | Target identification tool for intra body localization |
JP2011510797A (en) | 2008-02-06 | 2011-04-07 | ガイデッド デリバリー システムズ, インコーポレイテッド | Multiple window guide tunnel |
WO2011104269A1 (en) | 2008-02-26 | 2011-09-01 | Jenavalve Technology Inc. | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
US9044318B2 (en) | 2008-02-26 | 2015-06-02 | Jenavalve Technology Gmbh | Stent for the positioning and anchoring of a valvular prosthesis |
US8382829B1 (en) | 2008-03-10 | 2013-02-26 | Mitralign, Inc. | Method to reduce mitral regurgitation by cinching the commissure of the mitral valve |
JP2011517424A (en) * | 2008-04-08 | 2011-06-09 | リバース メディカル コーポレイション | Occlusion device and method of use |
US8858528B2 (en) | 2008-04-23 | 2014-10-14 | Ncontact Surgical, Inc. | Articulating cannula access device |
US20090276040A1 (en) | 2008-05-01 | 2009-11-05 | Edwards Lifesciences Corporation | Device and method for replacing mitral valve |
WO2009137712A1 (en) | 2008-05-07 | 2009-11-12 | Guided Delivery Systems Inc. | Deflectable guide |
US8267951B2 (en) | 2008-06-12 | 2012-09-18 | Ncontact Surgical, Inc. | Dissecting cannula and methods of use thereof |
US9192472B2 (en) | 2008-06-16 | 2015-11-24 | Valtec Cardio, Ltd. | Annuloplasty devices and methods of delivery therefor |
US20100010538A1 (en) * | 2008-07-11 | 2010-01-14 | Maquet Cardiovascular Llc | Reshaping the mitral valve of a heart |
AU2009288697B2 (en) * | 2008-09-05 | 2013-06-20 | Cook Medical Technologies Llc | Apparatus and methods for improved stent deployment |
US8945211B2 (en) | 2008-09-12 | 2015-02-03 | Mitralign, Inc. | Tissue plication device and method for its use |
US9023058B2 (en) * | 2008-10-07 | 2015-05-05 | Kardium Inc. | Surgical instrument and method for tensioning and securing a flexible suture |
US8888791B2 (en) * | 2008-10-07 | 2014-11-18 | Kardium Inc. | Surgical instrument and method for tensioning and securing a flexible suture |
AU2009302169B2 (en) | 2008-10-10 | 2016-01-14 | Ancora Heart, Inc. | Termination devices and related methods |
JP5607639B2 (en) | 2008-10-10 | 2014-10-15 | サドラ メディカル インコーポレイテッド | Medical devices and systems |
WO2010042857A1 (en) | 2008-10-10 | 2010-04-15 | Guided Delivery Systems Inc. | Tether tensioning devices and related methods |
EP2349086B1 (en) | 2008-10-16 | 2017-03-22 | Medtronic Vascular, Inc. | Devices and systems for endovascular staple and/or prosthesis delivery and implantation |
WO2010073246A2 (en) | 2008-12-22 | 2010-07-01 | Valtech Cardio, Ltd. | Adjustable annuloplasty devices and adjustment mechanisms therefor |
US9011530B2 (en) | 2008-12-22 | 2015-04-21 | Valtech Cardio, Ltd. | Partially-adjustable annuloplasty structure |
US8940044B2 (en) | 2011-06-23 | 2015-01-27 | Valtech Cardio, Ltd. | Closure element for use with an annuloplasty structure |
US8241351B2 (en) | 2008-12-22 | 2012-08-14 | Valtech Cardio, Ltd. | Adjustable partial annuloplasty ring and mechanism therefor |
US8545553B2 (en) | 2009-05-04 | 2013-10-01 | Valtech Cardio, Ltd. | Over-wire rotation tool |
US10517719B2 (en) | 2008-12-22 | 2019-12-31 | Valtech Cardio, Ltd. | Implantation of repair devices in the heart |
US8715342B2 (en) | 2009-05-07 | 2014-05-06 | Valtech Cardio, Ltd. | Annuloplasty ring with intra-ring anchoring |
US20110011917A1 (en) * | 2008-12-31 | 2011-01-20 | Hansen Medical, Inc. | Methods, devices, and kits for treating valve prolapse |
US20100185234A1 (en) | 2009-01-16 | 2010-07-22 | Abbott Vascular Inc. | Closure devices, systems, and methods |
WO2010085456A1 (en) | 2009-01-20 | 2010-07-29 | Guided Delivery Systems Inc. | Anchor deployment devices and related methods |
US8353956B2 (en) | 2009-02-17 | 2013-01-15 | Valtech Cardio, Ltd. | Actively-engageable movement-restriction mechanism for use with an annuloplasty structure |
IL197800A0 (en) * | 2009-03-25 | 2009-12-24 | Shmuel Ben Muvhar | Internal filtering device |
US9968452B2 (en) | 2009-05-04 | 2018-05-15 | Valtech Cardio, Ltd. | Annuloplasty ring delivery cathethers |
US9901347B2 (en) | 2009-05-29 | 2018-02-27 | Terus Medical, Inc. | Biliary shunts, delivery systems, and methods of using the same |
US20110054492A1 (en) | 2009-08-26 | 2011-03-03 | Abbott Laboratories | Medical device for repairing a fistula |
EP2477555B1 (en) | 2009-09-15 | 2013-12-25 | Evalve, Inc. | Device for cardiac valve repair |
JP5875986B2 (en) | 2009-10-26 | 2016-03-02 | カーディオキネティックス・インコーポレイテッドCardiokinetix, Inc. | Ventricular volume reduction |
US9011520B2 (en) | 2009-10-29 | 2015-04-21 | Valtech Cardio, Ltd. | Tissue anchor for annuloplasty device |
US10098737B2 (en) | 2009-10-29 | 2018-10-16 | Valtech Cardio, Ltd. | Tissue anchor for annuloplasty device |
US9180007B2 (en) | 2009-10-29 | 2015-11-10 | Valtech Cardio, Ltd. | Apparatus and method for guide-wire based advancement of an adjustable implant |
WO2011060437A1 (en) | 2009-11-16 | 2011-05-19 | Tornier, Inc. | Bone implant with convertible suture attachment |
WO2011067770A1 (en) | 2009-12-02 | 2011-06-09 | Valtech Cardio, Ltd. | Delivery tool for implantation of spool assembly coupled to a helical anchor |
WO2011069154A2 (en) | 2009-12-05 | 2011-06-09 | Integrated Sensing Systems, Inc. | Delivery system, method, and anchor for medical implant placement |
US8715300B2 (en) | 2009-12-05 | 2014-05-06 | Integrated Sensing Systems, Inc. | Delivery system, method, and anchor for medical implant placement |
US8870950B2 (en) | 2009-12-08 | 2014-10-28 | Mitral Tech Ltd. | Rotation-based anchoring of an implant |
US10058323B2 (en) | 2010-01-22 | 2018-08-28 | 4 Tech Inc. | Tricuspid valve repair using tension |
US8475525B2 (en) | 2010-01-22 | 2013-07-02 | 4Tech Inc. | Tricuspid valve repair using tension |
US9307980B2 (en) | 2010-01-22 | 2016-04-12 | 4Tech Inc. | Tricuspid valve repair using tension |
SE535690C2 (en) * | 2010-03-25 | 2012-11-13 | Jan Otto Solem | An implantable device and cardiac support kit, comprising means for generating longitudinal movement of the mitral valve |
US8795310B2 (en) | 2010-04-13 | 2014-08-05 | Sentreheart, Inc. | Methods and devices for accessing and delivering devices to a heart |
CN103002833B (en) | 2010-05-25 | 2016-05-11 | 耶拿阀门科技公司 | Artificial heart valve and comprise artificial heart valve and support through conduit carry interior prosthese |
US11653910B2 (en) | 2010-07-21 | 2023-05-23 | Cardiovalve Ltd. | Helical anchor implantation |
WO2012019052A2 (en) | 2010-08-04 | 2012-02-09 | Micardia Corporation | Percutaneous transcatheter repair of heart valves |
US9861350B2 (en) | 2010-09-03 | 2018-01-09 | Ancora Heart, Inc. | Devices and methods for anchoring tissue |
CA2808673C (en) | 2010-09-10 | 2019-07-02 | Symetis Sa | Valve replacement devices, delivery device for a valve replacement device and method of production of a valve replacement device |
US9655666B2 (en) | 2010-10-29 | 2017-05-23 | Medtronic Ablatio Frontiers LLC | Catheter with coronary sinus ostium anchor |
US9198756B2 (en) | 2010-11-18 | 2015-12-01 | Pavilion Medical Innovations, Llc | Tissue restraining devices and methods of use |
JP2014502859A (en) | 2010-11-18 | 2014-02-06 | パビリオン・メディカル・イノベーションズ・リミテッド・ライアビリティ・カンパニー | Tissue restraint device and method of use |
US20120190918A1 (en) * | 2011-01-21 | 2012-07-26 | Abbott Cardiovascular Systems, Inc. | Apparatus and methods for supporting cardiac ischemic tissue by means of embedded structures |
WO2012127309A1 (en) | 2011-03-21 | 2012-09-27 | Ontorfano Matteo | Disk-based valve apparatus and method for the treatment of valve dysfunction |
EP2520251A1 (en) | 2011-05-05 | 2012-11-07 | Symetis SA | Method and Apparatus for Compressing Stent-Valves |
WO2012158186A1 (en) * | 2011-05-17 | 2012-11-22 | Boston Scientific Scimed, Inc. | Percutaneous mitral annulus mini-plication |
US8747462B2 (en) | 2011-05-17 | 2014-06-10 | Boston Scientific Scimed, Inc. | Corkscrew annuloplasty device |
EP2709559B1 (en) | 2011-05-17 | 2015-01-21 | Boston Scientific Scimed, Inc. | Annuloplasty ring with anchors fixed by curing polymer |
US8814932B2 (en) | 2011-05-17 | 2014-08-26 | Boston Scientific Scimed, Inc. | Annuloplasty ring with piercing wire and segmented wire lumen |
US9402721B2 (en) | 2011-06-01 | 2016-08-02 | Valcare, Inc. | Percutaneous transcatheter repair of heart valves via trans-apical access |
US10792152B2 (en) | 2011-06-23 | 2020-10-06 | Valtech Cardio, Ltd. | Closed band for percutaneous annuloplasty |
WO2013009975A1 (en) | 2011-07-12 | 2013-01-17 | Boston Scientific Scimed, Inc. | Coupling system for medical devices |
US8945177B2 (en) | 2011-09-13 | 2015-02-03 | Abbott Cardiovascular Systems Inc. | Gripper pusher mechanism for tissue apposition systems |
US8858623B2 (en) | 2011-11-04 | 2014-10-14 | Valtech Cardio, Ltd. | Implant having multiple rotational assemblies |
EP3656434B1 (en) | 2011-11-08 | 2021-10-20 | Valtech Cardio, Ltd. | Controlled steering functionality for implant-delivery tool |
US9131926B2 (en) | 2011-11-10 | 2015-09-15 | Boston Scientific Scimed, Inc. | Direct connect flush system |
US8940014B2 (en) | 2011-11-15 | 2015-01-27 | Boston Scientific Scimed, Inc. | Bond between components of a medical device |
US8951243B2 (en) | 2011-12-03 | 2015-02-10 | Boston Scientific Scimed, Inc. | Medical device handle |
US9510945B2 (en) | 2011-12-20 | 2016-12-06 | Boston Scientific Scimed Inc. | Medical device handle |
US9277993B2 (en) | 2011-12-20 | 2016-03-08 | Boston Scientific Scimed, Inc. | Medical device delivery systems |
WO2013096757A1 (en) * | 2011-12-21 | 2013-06-27 | The Trustees Of The University Of Pennsylvania | Mechanical myocardial restraint device |
US10172708B2 (en) | 2012-01-25 | 2019-01-08 | Boston Scientific Scimed, Inc. | Valve assembly with a bioabsorbable gasket and a replaceable valve implant |
US9180008B2 (en) | 2012-02-29 | 2015-11-10 | Valcare, Inc. | Methods, devices, and systems for percutaneously anchoring annuloplasty rings |
WO2013130641A1 (en) | 2012-02-29 | 2013-09-06 | Valcare, Inc. | Percutaneous annuloplasty system with anterior-posterior adjustment |
US9901707B2 (en) * | 2012-05-23 | 2018-02-27 | Integra Lifesciences Switzerland Sàrl | Catheter curvature braces and methods of using same |
EP2854700B1 (en) | 2012-05-31 | 2021-07-07 | Javelin Medical Ltd. | Devices for embolic protection |
US8961594B2 (en) | 2012-05-31 | 2015-02-24 | 4Tech Inc. | Heart valve repair system |
US9883941B2 (en) | 2012-06-19 | 2018-02-06 | Boston Scientific Scimed, Inc. | Replacement heart valve |
US8979909B2 (en) | 2012-06-29 | 2015-03-17 | Depuy Mitek, Llc | Tissue repair suture plates and methods of use |
US11040230B2 (en) | 2012-08-31 | 2021-06-22 | Tini Alloy Company | Fire sprinkler valve actuator |
US10124197B2 (en) | 2012-08-31 | 2018-11-13 | TiNi Allot Company | Fire sprinkler valve actuator |
WO2014052818A1 (en) | 2012-09-29 | 2014-04-03 | Mitralign, Inc. | Plication lock delivery system and method of use thereof |
US10512482B2 (en) * | 2012-10-05 | 2019-12-24 | Board Of Regents Of The University Of Texas System | System and method for scoring the left ventricular endocardium to increase left ventricular compliance |
WO2014064695A2 (en) | 2012-10-23 | 2014-05-01 | Valtech Cardio, Ltd. | Percutaneous tissue anchor techniques |
EP3730084A1 (en) | 2012-10-23 | 2020-10-28 | Valtech Cardio, Ltd. | Controlled steering functionality for implant-delivery tool |
US9750626B2 (en) | 2012-10-31 | 2017-09-05 | Cook Medical Technologies Llc | Apparatus and methods for improved stent deployment |
WO2014087402A1 (en) | 2012-12-06 | 2014-06-12 | Valtech Cardio, Ltd. | Techniques for guide-wire based advancement of a tool |
US9364209B2 (en) | 2012-12-21 | 2016-06-14 | Abbott Cardiovascular Systems, Inc. | Articulating suturing device |
US9788948B2 (en) | 2013-01-09 | 2017-10-17 | 4 Tech Inc. | Soft tissue anchors and implantation techniques |
CN105007864B (en) | 2013-01-18 | 2017-03-22 | 标枪医疗有限公司 | Monofilament implants and systems for delivery thereof |
US20150351906A1 (en) | 2013-01-24 | 2015-12-10 | Mitraltech Ltd. | Ventricularly-anchored prosthetic valves |
BR112015017366A8 (en) * | 2013-01-25 | 2019-11-12 | Medtentia Int Ltd Oy | medical device to facilitate selection of an annuloplasty implant |
US9724084B2 (en) | 2013-02-26 | 2017-08-08 | Mitralign, Inc. | Devices and methods for percutaneous tricuspid valve repair |
US10449333B2 (en) | 2013-03-14 | 2019-10-22 | Valtech Cardio, Ltd. | Guidewire feeder |
US9907681B2 (en) | 2013-03-14 | 2018-03-06 | 4Tech Inc. | Stent with tether interface |
WO2014159842A1 (en) * | 2013-03-14 | 2014-10-02 | The United States Of America, As Represented By The Secretary, Department Of Health And Human Services | Devices and methods for treating functional tricuspid valve regurgitation |
CN105283214B (en) | 2013-03-15 | 2018-10-16 | 北京泰德制药股份有限公司 | Translate conduit, system and its application method |
EP2967700B1 (en) | 2013-03-15 | 2020-11-25 | Valcare, Inc. | Systems for delivery of annuloplasty rings |
EP2805695A1 (en) * | 2013-05-21 | 2014-11-26 | Medtentia International Ltd Oy | Medical system for annuloplasty |
US10813751B2 (en) | 2013-05-22 | 2020-10-27 | Valcare, Inc. | Transcatheter prosthetic valve for mitral or tricuspid valve replacement |
US20160120642A1 (en) | 2013-05-24 | 2016-05-05 | Valcare, Inc. | Heart and peripheral vascular valve replacement in conjunction with a support ring |
US10016192B2 (en) | 2013-06-14 | 2018-07-10 | Tornier, Inc. | Suture for connecting a human or animal tissue, soft anchor and method for attaching a tissue to a bone |
WO2014210600A2 (en) | 2013-06-28 | 2014-12-31 | Valcare, Inc. | Device, system, and method to secure an article to a tissue |
US9561103B2 (en) | 2013-07-17 | 2017-02-07 | Cephea Valve Technologies, Inc. | System and method for cardiac valve repair and replacement |
WO2015031476A1 (en) | 2013-08-27 | 2015-03-05 | Board Of Regents, The University Of Texas System | System and method for cutting trabeculae carneae of the left ventricle to increase lv compliance |
JP6563394B2 (en) | 2013-08-30 | 2019-08-21 | イェーナヴァルヴ テクノロジー インコーポレイテッド | Radially foldable frame for an artificial valve and method for manufacturing the frame |
US10070857B2 (en) | 2013-08-31 | 2018-09-11 | Mitralign, Inc. | Devices and methods for locating and implanting tissue anchors at mitral valve commissure |
CA2925667A1 (en) * | 2013-10-23 | 2015-04-30 | Lc Therapeutics, Inc. | Percutaneous or minimally invasive cardiac valve repair system and methods of using the same |
US10299793B2 (en) | 2013-10-23 | 2019-05-28 | Valtech Cardio, Ltd. | Anchor magazine |
US10022114B2 (en) | 2013-10-30 | 2018-07-17 | 4Tech Inc. | Percutaneous tether locking |
EP3062709A2 (en) | 2013-10-30 | 2016-09-07 | 4Tech Inc. | Multiple anchoring-point tension system |
US10052095B2 (en) | 2013-10-30 | 2018-08-21 | 4Tech Inc. | Multiple anchoring-point tension system |
EP3062711B1 (en) | 2013-10-31 | 2023-06-21 | AtriCure, Inc. | Devices for left atrial appendage closure |
US9592110B1 (en) | 2013-12-06 | 2017-03-14 | Javelin Medical, Ltd. | Systems and methods for implant delivery |
US9610162B2 (en) | 2013-12-26 | 2017-04-04 | Valtech Cardio, Ltd. | Implantation of flexible implant |
US9572666B2 (en) | 2014-03-17 | 2017-02-21 | Evalve, Inc. | Mitral valve fixation device removal devices and methods |
US10390943B2 (en) | 2014-03-17 | 2019-08-27 | Evalve, Inc. | Double orifice device for transcatheter mitral valve replacement |
US9918719B2 (en) * | 2014-06-08 | 2018-03-20 | Sano V Pte Ltd | Devices and methods for reshaping blood vessels |
EP3157607B1 (en) | 2014-06-19 | 2019-08-07 | 4Tech Inc. | Cardiac tissue cinching |
WO2016014244A1 (en) * | 2014-07-20 | 2016-01-28 | Riina Howard Anthony | Anchored suture line, device and method for surgical suturing |
GB2536538B (en) * | 2014-09-17 | 2018-07-18 | Cardiomech As | Anchor for implantation in body tissue |
US10751183B2 (en) | 2014-09-28 | 2020-08-25 | Edwards Lifesciences Corporation | Apparatuses for treating cardiac dysfunction |
WO2016059639A1 (en) | 2014-10-14 | 2016-04-21 | Valtech Cardio Ltd. | Leaflet-restraining techniques |
US10702368B2 (en) | 2014-10-27 | 2020-07-07 | Lithiblock Ltd. | Gallbladder implant and systems and methods for the delivery thereof |
US9901445B2 (en) | 2014-11-21 | 2018-02-27 | Boston Scientific Scimed, Inc. | Valve locking mechanism |
EP3284412A1 (en) | 2014-12-02 | 2018-02-21 | 4Tech Inc. | Off-center tissue anchors |
WO2016093877A1 (en) | 2014-12-09 | 2016-06-16 | Cephea Valve Technologies, Inc. | Replacement cardiac valves and methods of use and manufacture |
US10188392B2 (en) | 2014-12-19 | 2019-01-29 | Abbott Cardiovascular Systems, Inc. | Grasping for tissue repair |
US10779944B2 (en) | 2015-01-05 | 2020-09-22 | Strait Access Technologies Holdings (Pty) Ltd | Heart valve leaflet capture device |
WO2016115375A1 (en) | 2015-01-16 | 2016-07-21 | Boston Scientific Scimed, Inc. | Displacement based lock and release mechanism |
US9861477B2 (en) | 2015-01-26 | 2018-01-09 | Boston Scientific Scimed Inc. | Prosthetic heart valve square leaflet-leaflet stitch |
WO2016126524A1 (en) | 2015-02-03 | 2016-08-11 | Boston Scientific Scimed, Inc. | Prosthetic heart valve having tubular seal |
US9788942B2 (en) | 2015-02-03 | 2017-10-17 | Boston Scientific Scimed Inc. | Prosthetic heart valve having tubular seal |
WO2016125160A1 (en) | 2015-02-05 | 2016-08-11 | Mitraltech Ltd. | Prosthetic valve with axially-sliding frames |
US20160256269A1 (en) | 2015-03-05 | 2016-09-08 | Mitralign, Inc. | Devices for treating paravalvular leakage and methods use thereof |
WO2016141358A1 (en) | 2015-03-05 | 2016-09-09 | Guided Delivery Systems Inc. | Devices and methods of visualizing and determining depth of penetration in cardiac tissue |
US10285809B2 (en) | 2015-03-06 | 2019-05-14 | Boston Scientific Scimed Inc. | TAVI anchoring assist device |
US10426617B2 (en) | 2015-03-06 | 2019-10-01 | Boston Scientific Scimed, Inc. | Low profile valve locking mechanism and commissure assembly |
WO2016144391A1 (en) | 2015-03-11 | 2016-09-15 | Mvrx, Inc. | Devices, systems, and methods for reshaping a heart valve annulus |
US10080652B2 (en) | 2015-03-13 | 2018-09-25 | Boston Scientific Scimed, Inc. | Prosthetic heart valve having an improved tubular seal |
US10524912B2 (en) | 2015-04-02 | 2020-01-07 | Abbott Cardiovascular Systems, Inc. | Tissue fixation devices and methods |
CN114515173A (en) | 2015-04-30 | 2022-05-20 | 瓦尔泰克卡迪欧有限公司 | Valvuloplasty techniques |
CN107530168B (en) | 2015-05-01 | 2020-06-09 | 耶拿阀门科技股份有限公司 | Device and method with reduced pacemaker ratio in heart valve replacement |
CA2985659A1 (en) | 2015-05-12 | 2016-11-17 | Ancora Heart, Inc. | Device and method for releasing catheters from cardiac structures |
EP3294221B1 (en) | 2015-05-14 | 2024-03-06 | Cephea Valve Technologies, Inc. | Replacement mitral valves |
WO2018136959A1 (en) | 2017-01-23 | 2018-07-26 | Cephea Valve Technologies, Inc. | Replacement mitral valves |
EP3294220B1 (en) | 2015-05-14 | 2023-12-06 | Cephea Valve Technologies, Inc. | Cardiac valve delivery devices and systems |
US10376673B2 (en) | 2015-06-19 | 2019-08-13 | Evalve, Inc. | Catheter guiding system and methods |
US10238494B2 (en) | 2015-06-29 | 2019-03-26 | Evalve, Inc. | Self-aligning radiopaque ring |
WO2017004377A1 (en) | 2015-07-02 | 2017-01-05 | Boston Scientific Scimed, Inc. | Adjustable nosecone |
US10195392B2 (en) | 2015-07-02 | 2019-02-05 | Boston Scientific Scimed, Inc. | Clip-on catheter |
US10667815B2 (en) | 2015-07-21 | 2020-06-02 | Evalve, Inc. | Tissue grasping devices and related methods |
US10413408B2 (en) | 2015-08-06 | 2019-09-17 | Evalve, Inc. | Delivery catheter systems, methods, and devices |
US10136991B2 (en) | 2015-08-12 | 2018-11-27 | Boston Scientific Scimed Inc. | Replacement heart valve implant |
US10179041B2 (en) | 2015-08-12 | 2019-01-15 | Boston Scientific Scimed Icn. | Pinless release mechanism |
US10779940B2 (en) | 2015-09-03 | 2020-09-22 | Boston Scientific Scimed, Inc. | Medical device handle |
US10238495B2 (en) | 2015-10-09 | 2019-03-26 | Evalve, Inc. | Delivery catheter handle and methods of use |
EP3386440A4 (en) * | 2015-12-10 | 2019-11-13 | MVRx, Inc. | Devices, systems, and methods for reshaping a heart valve annulus |
WO2017117370A2 (en) * | 2015-12-30 | 2017-07-06 | Mitralign, Inc. | System and method for reducing tricuspid regurgitation |
US10751182B2 (en) | 2015-12-30 | 2020-08-25 | Edwards Lifesciences Corporation | System and method for reshaping right heart |
US10342660B2 (en) | 2016-02-02 | 2019-07-09 | Boston Scientific Inc. | Tensioned sheathing aids |
US10531866B2 (en) | 2016-02-16 | 2020-01-14 | Cardiovalve Ltd. | Techniques for providing a replacement valve and transseptal communication |
US11058538B2 (en) | 2016-03-10 | 2021-07-13 | Charles Somers Living Trust | Synthetic chord for cardiac valve repair applications |
US10780280B2 (en) | 2016-04-26 | 2020-09-22 | Mayo Foundation For Medical Education And Research | Devices and methods for cardiac pacing and resynchronization |
US11039923B2 (en) | 2016-05-06 | 2021-06-22 | Transmural Systems Llc | Annuloplasty procedures, related devices and methods |
WO2017193123A1 (en) | 2016-05-06 | 2017-11-09 | Nasser Rafiee | Annuloplasty procedures, related devices and methods |
US11007059B2 (en) | 2016-05-06 | 2021-05-18 | Transmural Systems Llc | Annuloplasty procedures, related devices and methods |
EP4183371A1 (en) | 2016-05-13 | 2023-05-24 | JenaValve Technology, Inc. | Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath and loading system |
US10583005B2 (en) | 2016-05-13 | 2020-03-10 | Boston Scientific Scimed, Inc. | Medical device handle |
US10245136B2 (en) | 2016-05-13 | 2019-04-02 | Boston Scientific Scimed Inc. | Containment vessel with implant sheathing guide |
US20200146854A1 (en) | 2016-05-16 | 2020-05-14 | Elixir Medical Corporation | Methods and devices for heart valve repair |
US10201416B2 (en) | 2016-05-16 | 2019-02-12 | Boston Scientific Scimed, Inc. | Replacement heart valve implant with invertible leaflets |
US10702274B2 (en) | 2016-05-26 | 2020-07-07 | Edwards Lifesciences Corporation | Method and system for closing left atrial appendage |
US11331187B2 (en) | 2016-06-17 | 2022-05-17 | Cephea Valve Technologies, Inc. | Cardiac valve delivery devices and systems |
US10736632B2 (en) | 2016-07-06 | 2020-08-11 | Evalve, Inc. | Methods and devices for valve clip excision |
GB201611910D0 (en) | 2016-07-08 | 2016-08-24 | Valtech Cardio Ltd | Adjustable annuloplasty device with alternating peaks and troughs |
EP3848003A1 (en) | 2016-08-10 | 2021-07-14 | Cardiovalve Ltd. | Prosthetic valve with concentric frames |
US10383725B2 (en) | 2016-08-11 | 2019-08-20 | 4C Medical Technologies, Inc. | Heart chamber prosthetic valve implant with base, mesh and dome sections with single chamber anchoring for preservation, supplementation and/or replacement of native valve function |
CN107753153B (en) | 2016-08-15 | 2022-05-31 | 沃卡尔有限公司 | Device and method for treating heart valve insufficiency |
US11071564B2 (en) | 2016-10-05 | 2021-07-27 | Evalve, Inc. | Cardiac valve cutting device |
JP7222886B2 (en) | 2016-10-21 | 2023-02-15 | ジャベリン メディカル リミテッド | Systems, methods, and devices for embolic protection |
US10363138B2 (en) | 2016-11-09 | 2019-07-30 | Evalve, Inc. | Devices for adjusting the curvature of cardiac valve structures |
US10398553B2 (en) | 2016-11-11 | 2019-09-03 | Evalve, Inc. | Opposing disk device for grasping cardiac valve tissue |
US10426616B2 (en) | 2016-11-17 | 2019-10-01 | Evalve, Inc. | Cardiac implant delivery system |
CN116746975A (en) | 2016-11-18 | 2023-09-15 | 复心公司 | Myocardial implant load sharing apparatus and method for promoting LV function |
US10779837B2 (en) | 2016-12-08 | 2020-09-22 | Evalve, Inc. | Adjustable arm device for grasping tissues |
US10314586B2 (en) | 2016-12-13 | 2019-06-11 | Evalve, Inc. | Rotatable device and method for fixing tricuspid valve tissue |
US10653523B2 (en) | 2017-01-19 | 2020-05-19 | 4C Medical Technologies, Inc. | Systems, methods and devices for delivery systems, methods and devices for implanting prosthetic heart valves |
AU2018203053B2 (en) | 2017-01-23 | 2020-03-05 | Cephea Valve Technologies, Inc. | Replacement mitral valves |
US10561495B2 (en) | 2017-01-24 | 2020-02-18 | 4C Medical Technologies, Inc. | Systems, methods and devices for two-step delivery and implantation of prosthetic heart valve |
JP7094965B2 (en) | 2017-01-27 | 2022-07-04 | イエナバルブ テクノロジー インク | Heart valve imitation |
CN108618871A (en) | 2017-03-17 | 2018-10-09 | 沃卡尔有限公司 | Bicuspid valve with multi-direction anchor portion or tricuspid valve repair system |
DE102018107407A1 (en) | 2017-03-28 | 2018-10-04 | Edwards Lifesciences Corporation | POSITIONING, INSERTING AND RETRIEVING IMPLANTABLE DEVICES |
US11045627B2 (en) | 2017-04-18 | 2021-06-29 | Edwards Lifesciences Corporation | Catheter system with linear actuation control mechanism |
EP3621529A1 (en) | 2017-05-12 | 2020-03-18 | Evalve, Inc. | Long arm valve repair clip |
WO2018226915A1 (en) | 2017-06-08 | 2018-12-13 | Boston Scientific Scimed, Inc. | Heart valve implant commissure support structure |
WO2019022168A1 (en) * | 2017-07-25 | 2019-01-31 | 千貴 寺嶋 | Vascular marker for radiotherapy, radiotherapy assistance method, radiation irradiation control device, and vascular marker indwelling assistance device |
CN111163729B (en) | 2017-08-01 | 2022-03-29 | 波士顿科学国际有限公司 | Medical implant locking mechanism |
US10939996B2 (en) | 2017-08-16 | 2021-03-09 | Boston Scientific Scimed, Inc. | Replacement heart valve commissure assembly |
EP3672532B1 (en) | 2017-08-26 | 2022-08-03 | Transmural Systems LLC | Implantable cardiac pacing system |
WO2019079788A1 (en) | 2017-10-20 | 2019-04-25 | Boston Scientific Scimed, Inc. | Heart valve repair implant for treating tricuspid regurgitation |
US10835221B2 (en) | 2017-11-02 | 2020-11-17 | Valtech Cardio, Ltd. | Implant-cinching devices and systems |
US11135062B2 (en) | 2017-11-20 | 2021-10-05 | Valtech Cardio Ltd. | Cinching of dilated heart muscle |
US11246625B2 (en) | 2018-01-19 | 2022-02-15 | Boston Scientific Scimed, Inc. | Medical device delivery system with feedback loop |
JP7055882B2 (en) | 2018-01-19 | 2022-04-18 | ボストン サイエンティフィック サイムド,インコーポレイテッド | Guidance mode indwelling sensor for transcatheter valve system |
CN116531147A (en) | 2018-01-24 | 2023-08-04 | 爱德华兹生命科学创新(以色列)有限公司 | Contraction of annuloplasty structures |
EP3743014B1 (en) | 2018-01-26 | 2023-07-19 | Edwards Lifesciences Innovation (Israel) Ltd. | Techniques for facilitating heart valve tethering and chord replacement |
US11147668B2 (en) | 2018-02-07 | 2021-10-19 | Boston Scientific Scimed, Inc. | Medical device delivery system with alignment feature |
WO2019165394A1 (en) | 2018-02-26 | 2019-08-29 | Boston Scientific Scimed, Inc. | Embedded radiopaque marker in adaptive seal |
CN112399836A (en) | 2018-05-15 | 2021-02-23 | 波士顿科学国际有限公司 | Replacement heart valve commissure assemblies |
US20190365539A1 (en) * | 2018-05-29 | 2019-12-05 | Edwards Lifesciences Corporation | Reverse ventricular remodeling and papillary muscle approximation |
US11241310B2 (en) | 2018-06-13 | 2022-02-08 | Boston Scientific Scimed, Inc. | Replacement heart valve delivery device |
CR20210020A (en) | 2018-07-12 | 2021-07-21 | Valtech Cardio Ltd | Annuloplasty systems and locking tools therefor |
US11857441B2 (en) | 2018-09-04 | 2024-01-02 | 4C Medical Technologies, Inc. | Stent loading device |
US11191548B2 (en) * | 2018-09-18 | 2021-12-07 | Amsel Medical Corporation | Method and apparatus for intraluminally occluding hollow or tubular body structures |
EP3890658A4 (en) | 2018-12-03 | 2022-12-21 | Valcare, Inc. | Stabilizing and adjusting tool for controlling a minimally invasive mitral / tricuspid valve repair system |
WO2020123486A1 (en) | 2018-12-10 | 2020-06-18 | Boston Scientific Scimed, Inc. | Medical device delivery system including a resistance member |
JP7297189B2 (en) * | 2019-02-06 | 2023-06-26 | リキッドメタル テクノロジーズ,インコーポレイティド | Implantable medical device with bulk metallic glass enclosure |
US11439504B2 (en) | 2019-05-10 | 2022-09-13 | Boston Scientific Scimed, Inc. | Replacement heart valve with improved cusp washout and reduced loading |
EP3998995A4 (en) | 2019-07-15 | 2023-08-23 | ValCare, Inc. | Transcatheter bio-prosthesis member and support structure |
CA3147413A1 (en) | 2019-07-15 | 2021-01-21 | Ancora Heart, Inc. | Devices and methods for tether cutting |
CA3142906A1 (en) | 2019-10-29 | 2021-05-06 | Valtech Cardio, Ltd. | Annuloplasty and tissue anchor technologies |
US11931253B2 (en) | 2020-01-31 | 2024-03-19 | 4C Medical Technologies, Inc. | Prosthetic heart valve delivery system: ball-slide attachment |
US11951002B2 (en) * | 2020-03-30 | 2024-04-09 | Tendyne Holdings, Inc. | Apparatus and methods for valve and tether fixation |
US11857417B2 (en) | 2020-08-16 | 2024-01-02 | Trilio Medical Ltd. | Leaflet support |
WO2024030830A1 (en) * | 2022-08-04 | 2024-02-08 | Edwards Lifesciences Corporation | Compliance-enhancing bands |
Citations (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6210432B1 (en) * | 1999-06-29 | 2001-04-03 | Jan Otto Solem | Device and method for treatment of mitral insufficiency |
US6402781B1 (en) * | 2000-01-31 | 2002-06-11 | Mitralife | Percutaneous mitral annuloplasty and cardiac reinforcement |
US20020087173A1 (en) * | 2000-12-28 | 2002-07-04 | Alferness Clifton A. | Mitral valve constricting device, system and method |
US20020169504A1 (en) * | 2001-05-14 | 2002-11-14 | Alferness Clifton A. | Mitral valve therapy device, system and method |
US20020169502A1 (en) * | 2001-05-14 | 2002-11-14 | Cardiac Dimensions, Inc. | Mitral valve therapy assembly and method |
US20030078465A1 (en) * | 2001-10-16 | 2003-04-24 | Suresh Pai | Systems for heart treatment |
US20030083538A1 (en) * | 2001-11-01 | 2003-05-01 | Cardiac Dimensions, Inc. | Focused compression mitral valve device and method |
US6569198B1 (en) * | 2000-03-31 | 2003-05-27 | Richard A. Wilson | Mitral or tricuspid valve annuloplasty prosthetic device |
US20030105520A1 (en) * | 2001-12-05 | 2003-06-05 | Cardiac Dimensions, Inc. | Anchor and pull mitral valve device and method |
US20030130731A1 (en) * | 2002-01-09 | 2003-07-10 | Myocor, Inc. | Devices and methods for heart valve treatment |
US6629921B1 (en) * | 1997-01-02 | 2003-10-07 | Myocor, Inc. | Heart wall tension reduction apparatus and method |
US6656221B2 (en) * | 2001-02-05 | 2003-12-02 | Viacor, Inc. | Method and apparatus for improving mitral valve function |
US6723038B1 (en) * | 2000-10-06 | 2004-04-20 | Myocor, Inc. | Methods and devices for improving mitral valve function |
US6790231B2 (en) * | 2001-02-05 | 2004-09-14 | Viacor, Inc. | Apparatus and method for reducing mitral regurgitation |
US6793618B2 (en) * | 1997-01-02 | 2004-09-21 | Myocor, Inc. | Heart wall tension reduction apparatus |
US7192442B2 (en) * | 1999-06-30 | 2007-03-20 | Edwards Lifesciences Ag | Method and device for treatment of mitral insufficiency |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5649951A (en) * | 1989-07-25 | 1997-07-22 | Smith & Nephew Richards, Inc. | Zirconium oxide and zirconium nitride coated stents |
US5064435A (en) * | 1990-06-28 | 1991-11-12 | Schneider (Usa) Inc. | Self-expanding prosthesis having stable axial length |
JPH09215753A (en) * | 1996-02-08 | 1997-08-19 | Schneider Usa Inc | Self-expanding stent made of titanium alloy |
US6296603B1 (en) * | 1998-05-26 | 2001-10-02 | Isostent, Inc. | Radioactive intraluminal endovascular prosthesis and method for the treatment of aneurysms |
-
2002
- 2002-10-11 US US10/269,844 patent/US7144363B2/en not_active Expired - Fee Related
-
2005
- 2005-05-02 US US11/120,470 patent/US20050197692A1/en not_active Abandoned
- 2005-05-02 US US11/120,716 patent/US20050197693A1/en not_active Abandoned
- 2005-05-02 US US11/120,717 patent/US20050197694A1/en not_active Abandoned
Patent Citations (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6793618B2 (en) * | 1997-01-02 | 2004-09-21 | Myocor, Inc. | Heart wall tension reduction apparatus |
US6629921B1 (en) * | 1997-01-02 | 2003-10-07 | Myocor, Inc. | Heart wall tension reduction apparatus and method |
US6210432B1 (en) * | 1999-06-29 | 2001-04-03 | Jan Otto Solem | Device and method for treatment of mitral insufficiency |
US7192442B2 (en) * | 1999-06-30 | 2007-03-20 | Edwards Lifesciences Ag | Method and device for treatment of mitral insufficiency |
US6402781B1 (en) * | 2000-01-31 | 2002-06-11 | Mitralife | Percutaneous mitral annuloplasty and cardiac reinforcement |
US6569198B1 (en) * | 2000-03-31 | 2003-05-27 | Richard A. Wilson | Mitral or tricuspid valve annuloplasty prosthetic device |
US6723038B1 (en) * | 2000-10-06 | 2004-04-20 | Myocor, Inc. | Methods and devices for improving mitral valve function |
US20020087173A1 (en) * | 2000-12-28 | 2002-07-04 | Alferness Clifton A. | Mitral valve constricting device, system and method |
US6656221B2 (en) * | 2001-02-05 | 2003-12-02 | Viacor, Inc. | Method and apparatus for improving mitral valve function |
US20050071000A1 (en) * | 2001-02-05 | 2005-03-31 | Liddicoat John R. | Apparatus and method for reducing mitral regurgitation |
US6790231B2 (en) * | 2001-02-05 | 2004-09-14 | Viacor, Inc. | Apparatus and method for reducing mitral regurgitation |
US20020169502A1 (en) * | 2001-05-14 | 2002-11-14 | Cardiac Dimensions, Inc. | Mitral valve therapy assembly and method |
US20020169504A1 (en) * | 2001-05-14 | 2002-11-14 | Alferness Clifton A. | Mitral valve therapy device, system and method |
US20030078465A1 (en) * | 2001-10-16 | 2003-04-24 | Suresh Pai | Systems for heart treatment |
US20030083538A1 (en) * | 2001-11-01 | 2003-05-01 | Cardiac Dimensions, Inc. | Focused compression mitral valve device and method |
US20030105520A1 (en) * | 2001-12-05 | 2003-06-05 | Cardiac Dimensions, Inc. | Anchor and pull mitral valve device and method |
US20030130731A1 (en) * | 2002-01-09 | 2003-07-10 | Myocor, Inc. | Devices and methods for heart valve treatment |
Cited By (231)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7883539B2 (en) | 1997-01-02 | 2011-02-08 | Edwards Lifesciences Llc | Heart wall tension reduction apparatus and method |
US8267852B2 (en) | 1997-01-02 | 2012-09-18 | Edwards Lifesciences, Llc | Heart wall tension reduction apparatus and method |
US8460173B2 (en) | 1997-01-02 | 2013-06-11 | Edwards Lifesciences, Llc | Heart wall tension reduction apparatus and method |
US8226711B2 (en) | 1997-12-17 | 2012-07-24 | Edwards Lifesciences, Llc | Valve to myocardium tension members device and method |
US8333204B2 (en) | 1999-06-25 | 2012-12-18 | Hansen Medical, Inc. | Apparatus and methods for treating tissue |
US20070208357A1 (en) * | 1999-06-25 | 2007-09-06 | Houser Russell A | Apparatus and methods for treating tissue |
US8523883B2 (en) | 1999-06-25 | 2013-09-03 | Hansen Medical, Inc. | Apparatus and methods for treating tissue |
US7766812B2 (en) | 2000-10-06 | 2010-08-03 | Edwards Lifesciences Llc | Methods and devices for improving mitral valve function |
US9198757B2 (en) | 2000-10-06 | 2015-12-01 | Edwards Lifesciences, Llc | Methods and devices for improving mitral valve function |
US7776053B2 (en) | 2000-10-26 | 2010-08-17 | Boston Scientific Scimed, Inc. | Implantable valve system |
US8439971B2 (en) | 2001-11-01 | 2013-05-14 | Cardiac Dimensions, Inc. | Adjustable height focal tissue deflector |
US7674287B2 (en) | 2001-12-05 | 2010-03-09 | Cardiac Dimensions, Inc. | Device and method for modifying the shape of a body organ |
US7857846B2 (en) | 2001-12-05 | 2010-12-28 | Cardiac Dimensions, Inc. | Device and method for modifying the shape of a body organ |
US8172898B2 (en) | 2001-12-05 | 2012-05-08 | Cardiac Dimensions, Inc. | Device and method for modifying the shape of a body organ |
US8506624B2 (en) | 2002-01-09 | 2013-08-13 | Edwards Lifesciences, Llc | Devices and methods for heart valve treatment |
US8070805B2 (en) | 2002-01-09 | 2011-12-06 | Edwards Lifesciences Llc | Devices and methods for heart valve treatment |
US7678145B2 (en) | 2002-01-09 | 2010-03-16 | Edwards Lifesciences Llc | Devices and methods for heart valve treatment |
US20030236569A1 (en) * | 2002-01-30 | 2003-12-25 | Cardiac Dimensions, Inc. | Device and method for modifying the shape of a body organ |
US9827098B2 (en) | 2002-01-30 | 2017-11-28 | Cardiac Dimensions Pty. Ltd. | Fixed anchor and pull mitral valve device and method |
US9827099B2 (en) | 2002-01-30 | 2017-11-28 | Cardiac Dimensions Pty. Ltd. | Tissue shaping device |
US7828842B2 (en) | 2002-01-30 | 2010-11-09 | Cardiac Dimensions, Inc. | Tissue shaping device |
US10052205B2 (en) | 2002-01-30 | 2018-08-21 | Cardiac Dimensions Pty. Ltd. | Fixed anchor and pull mitral valve device and method |
US9408695B2 (en) | 2002-01-30 | 2016-08-09 | Cardiac Dimensions Pty. Ltd. | Fixed anchor and pull mitral valve device and method |
US9956076B2 (en) | 2002-01-30 | 2018-05-01 | Cardiac Dimensions Pty. Ltd. | Tissue shaping device |
US8974525B2 (en) | 2002-01-30 | 2015-03-10 | Cardiac Dimensions Pty. Ltd. | Tissue shaping device |
US9320600B2 (en) | 2002-01-30 | 2016-04-26 | Cardiac Dimensions Pty. Ltd. | Tissue shaping device |
US9827100B2 (en) | 2002-01-30 | 2017-11-28 | Cardiac Dimensions Pty. Ltd. | Tissue shaping device |
US10327900B2 (en) | 2002-01-30 | 2019-06-25 | Cardiac Dimensions Pty. Ltd. | Tissue shaping device |
US9597186B2 (en) | 2002-01-30 | 2017-03-21 | Cardiac Dimensions Pty. Ltd. | Tissue shaping device |
US10206778B2 (en) | 2002-01-30 | 2019-02-19 | Cardiac Dimensions Pty. Ltd. | Tissue shaping device |
US20060030882A1 (en) * | 2002-03-06 | 2006-02-09 | Adams John M | Transvenous staples, assembly and method for mitral valve repair |
US7682385B2 (en) | 2002-04-03 | 2010-03-23 | Boston Scientific Corporation | Artificial valve |
US7828841B2 (en) | 2002-05-08 | 2010-11-09 | Cardiac Dimensions, Inc. | Device and method for modifying the shape of a body organ |
US20060173536A1 (en) * | 2002-05-08 | 2006-08-03 | Mathis Mark L | Body lumen device anchor, device and assembly |
US10456257B2 (en) | 2002-05-08 | 2019-10-29 | Cardiac Dimensions Pty. Ltd. | Tissue shaping device |
US8062358B2 (en) | 2002-05-08 | 2011-11-22 | Cardiac Dimensions, Inc. | Body lumen device anchor, device and assembly |
US10456258B2 (en) | 2002-05-08 | 2019-10-29 | Cardiac Dimensions Pty. Ltd. | Tissue shaping device |
US9474608B2 (en) | 2002-05-08 | 2016-10-25 | Cardiac Dimensions Pty. Ltd. | Body lumen device anchor, device and assembly |
US7666224B2 (en) | 2002-11-12 | 2010-02-23 | Edwards Lifesciences Llc | Devices and methods for heart valve treatment |
US8182529B2 (en) | 2002-12-05 | 2012-05-22 | Cardiac Dimensions, Inc. | Percutaneous mitral valve annuloplasty device delivery method |
US7837729B2 (en) | 2002-12-05 | 2010-11-23 | Cardiac Dimensions, Inc. | Percutaneous mitral valve annuloplasty delivery system |
US8075608B2 (en) | 2002-12-05 | 2011-12-13 | Cardiac Dimensions, Inc. | Medical device delivery system |
US7780627B2 (en) | 2002-12-30 | 2010-08-24 | Boston Scientific Scimed, Inc. | Valve treatment catheter and methods |
US20040133240A1 (en) * | 2003-01-07 | 2004-07-08 | Cardiac Dimensions, Inc. | Electrotherapy system, device, and method for treatment of cardiac valve dysfunction |
US7758639B2 (en) | 2003-02-03 | 2010-07-20 | Cardiac Dimensions, Inc. | Mitral valve device using conditioned shape memory alloy |
US11311380B2 (en) | 2003-05-02 | 2022-04-26 | Cardiac Dimensions Pty. Ltd. | Device and method for modifying the shape of a body organ |
US20040220657A1 (en) * | 2003-05-02 | 2004-11-04 | Cardiac Dimensions, Inc., A Washington Corporation | Tissue shaping device with conformable anchors |
US11452603B2 (en) | 2003-05-02 | 2022-09-27 | Cardiac Dimensions Pty. Ltd. | Device and method for modifying the shape of a body organ |
US7887582B2 (en) | 2003-06-05 | 2011-02-15 | Cardiac Dimensions, Inc. | Device and method for modifying the shape of a body organ |
US20050015109A1 (en) * | 2003-07-16 | 2005-01-20 | Samuel Lichtenstein | Methods and devices for altering blood flow through the left ventricle |
US7513867B2 (en) | 2003-07-16 | 2009-04-07 | Kardium, Inc. | Methods and devices for altering blood flow through the left ventricle |
US20070083076A1 (en) * | 2003-07-16 | 2007-04-12 | Samuel Lichtenstein | Methods and devices for altering blood flow through the left ventricle |
US10869764B2 (en) | 2003-12-19 | 2020-12-22 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US7854761B2 (en) | 2003-12-19 | 2010-12-21 | Boston Scientific Scimed, Inc. | Methods for venous valve replacement with a catheter |
US7814635B2 (en) | 2003-12-19 | 2010-10-19 | Cardiac Dimensions, Inc. | Method of making a tissue shaping device |
US9301843B2 (en) | 2003-12-19 | 2016-04-05 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US7794496B2 (en) | 2003-12-19 | 2010-09-14 | Cardiac Dimensions, Inc. | Tissue shaping device with integral connector and crimp |
US8128681B2 (en) | 2003-12-19 | 2012-03-06 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US10449048B2 (en) | 2003-12-19 | 2019-10-22 | Cardiac Dimensions Pty. Ltd. | Mitral valve annuloplasty device with twisted anchor |
US10166102B2 (en) | 2003-12-19 | 2019-01-01 | Cardiac Dimensions Pty. Ltd. | Mitral valve annuloplasty device with twisted anchor |
US7837728B2 (en) | 2003-12-19 | 2010-11-23 | Cardiac Dimensions, Inc. | Reduced length tissue shaping device |
US11318016B2 (en) | 2003-12-19 | 2022-05-03 | Cardiac Dimensions Pty. Ltd. | Mitral valve annuloplasty device with twisted anchor |
US8721717B2 (en) | 2003-12-19 | 2014-05-13 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US9956077B2 (en) | 2003-12-19 | 2018-05-01 | Cardiac Dimensions Pty. Ltd. | Mitral valve annuloplasty device with twisted anchor |
US11109971B2 (en) | 2003-12-19 | 2021-09-07 | Cardiac Dimensions Pty. Ltd. | Mitral valve annuloplasty device with twisted anchor |
US9526616B2 (en) | 2003-12-19 | 2016-12-27 | Cardiac Dimensions Pty. Ltd. | Mitral valve annuloplasty device with twisted anchor |
US8926603B2 (en) | 2004-03-05 | 2015-01-06 | Hansen Medical, Inc. | System and method for denaturing and fixing collagenous tissue |
US7976539B2 (en) | 2004-03-05 | 2011-07-12 | Hansen Medical, Inc. | System and method for denaturing and fixing collagenous tissue |
US9918834B2 (en) | 2004-09-02 | 2018-03-20 | Boston Scientific Scimed, Inc. | Cardiac valve, system and method |
US8932349B2 (en) | 2004-09-02 | 2015-01-13 | Boston Scientific Scimed, Inc. | Cardiac valve, system, and method |
US8002824B2 (en) | 2004-09-02 | 2011-08-23 | Boston Scientific Scimed, Inc. | Cardiac valve, system, and method |
US11033257B2 (en) | 2005-01-20 | 2021-06-15 | Cardiac Dimensions Pty. Ltd. | Tissue shaping device |
US7854755B2 (en) | 2005-02-01 | 2010-12-21 | Boston Scientific Scimed, Inc. | Vascular catheter, system, and method |
US9622859B2 (en) | 2005-02-01 | 2017-04-18 | Boston Scientific Scimed, Inc. | Filter system and method |
US7878966B2 (en) | 2005-02-04 | 2011-02-01 | Boston Scientific Scimed, Inc. | Ventricular assist and support device |
US7780722B2 (en) | 2005-02-07 | 2010-08-24 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US7670368B2 (en) | 2005-02-07 | 2010-03-02 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US9370419B2 (en) | 2005-02-23 | 2016-06-21 | Boston Scientific Scimed, Inc. | Valve apparatus, system and method |
US9808341B2 (en) | 2005-02-23 | 2017-11-07 | Boston Scientific Scimed Inc. | Valve apparatus, system and method |
US7722666B2 (en) | 2005-04-15 | 2010-05-25 | Boston Scientific Scimed, Inc. | Valve apparatus, system and method |
US8512399B2 (en) | 2005-04-15 | 2013-08-20 | Boston Scientific Scimed, Inc. | Valve apparatus, system and method |
US9861473B2 (en) | 2005-04-15 | 2018-01-09 | Boston Scientific Scimed Inc. | Valve apparatus, system and method |
US9028542B2 (en) | 2005-06-10 | 2015-05-12 | Boston Scientific Scimed, Inc. | Venous valve, system, and method |
US11337812B2 (en) | 2005-06-10 | 2022-05-24 | Boston Scientific Scimed, Inc. | Venous valve, system and method |
US8012198B2 (en) | 2005-06-10 | 2011-09-06 | Boston Scientific Scimed, Inc. | Venous valve, system, and method |
US8672997B2 (en) | 2005-09-21 | 2014-03-18 | Boston Scientific Scimed, Inc. | Valve with sinus |
US7951189B2 (en) | 2005-09-21 | 2011-05-31 | Boston Scientific Scimed, Inc. | Venous valve, system, and method with sinus pocket |
US8460365B2 (en) | 2005-09-21 | 2013-06-11 | Boston Scientific Scimed, Inc. | Venous valve, system, and method with sinus pocket |
US8545551B2 (en) | 2005-11-23 | 2013-10-01 | Hansen Medical, Inc. | Methods, devices, and kits for treating mitral valve prolapse |
US7799038B2 (en) | 2006-01-20 | 2010-09-21 | Boston Scientific Scimed, Inc. | Translumenal apparatus, system, and method |
US7938767B2 (en) | 2006-02-06 | 2011-05-10 | Northwind Ventures | Systems and methods for volume reduction |
US20080293996A1 (en) * | 2006-02-06 | 2008-11-27 | Evans Michael A | Systems and methods for volume reduction |
US20110178362A1 (en) * | 2006-02-06 | 2011-07-21 | Evans Michael A | Systems and methods for volume reduction |
US7749249B2 (en) | 2006-02-21 | 2010-07-06 | Kardium Inc. | Method and device for closing holes in tissue |
US8337524B2 (en) | 2006-02-21 | 2012-12-25 | Kardium Inc. | Method and device for closing holes in tissue |
US9572557B2 (en) | 2006-02-21 | 2017-02-21 | Kardium Inc. | Method and device for closing holes in tissue |
US8150499B2 (en) | 2006-05-19 | 2012-04-03 | Kardium Inc. | Automatic atherectomy system |
US8532746B2 (en) | 2006-05-19 | 2013-09-10 | Kardium Inc. | Automatic atherectomy system |
US8672998B2 (en) | 2006-06-28 | 2014-03-18 | Kardium Inc. | Method for anchoring a mitral valve |
US9119634B2 (en) | 2006-06-28 | 2015-09-01 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US9119633B2 (en) | 2006-06-28 | 2015-09-01 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US9192468B2 (en) | 2006-06-28 | 2015-11-24 | Kardium Inc. | Method for anchoring a mitral valve |
US11399890B2 (en) | 2006-06-28 | 2022-08-02 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US10828094B2 (en) | 2006-06-28 | 2020-11-10 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US10828093B2 (en) | 2006-06-28 | 2020-11-10 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US11389231B2 (en) | 2006-06-28 | 2022-07-19 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US8449605B2 (en) | 2006-06-28 | 2013-05-28 | Kardium Inc. | Method for anchoring a mitral valve |
US10820941B2 (en) | 2006-06-28 | 2020-11-03 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US9987083B2 (en) | 2006-06-28 | 2018-06-05 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US9987084B2 (en) | 2006-06-28 | 2018-06-05 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US8920411B2 (en) | 2006-06-28 | 2014-12-30 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US11389232B2 (en) | 2006-06-28 | 2022-07-19 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US10028783B2 (en) | 2006-06-28 | 2018-07-24 | Kardium Inc. | Apparatus and method for intra-cardiac mapping and ablation |
US9033896B2 (en) * | 2006-07-13 | 2015-05-19 | Mayo Foundation For Medical Education And Research | Obtaining a tissue sample |
US20080015466A1 (en) * | 2006-07-13 | 2008-01-17 | Mayo Foundation For Medical Education And Research | Obtaining a tissue sample |
US11285005B2 (en) | 2006-07-17 | 2022-03-29 | Cardiac Dimensions Pty. Ltd. | Mitral valve annuloplasty device with twisted anchor |
US7837610B2 (en) | 2006-08-02 | 2010-11-23 | Kardium Inc. | System for improving diastolic dysfunction |
US11033392B2 (en) | 2006-08-02 | 2021-06-15 | Kardium Inc. | System for improving diastolic dysfunction |
WO2008030328A3 (en) * | 2006-09-10 | 2008-08-14 | Seth J Worley | Pacing lead and method for pacing in the pericardial space |
US20080065185A1 (en) * | 2006-09-10 | 2008-03-13 | Seth Worley | Pacing lead and method for pacing in the pericardial space |
WO2008030328A2 (en) * | 2006-09-10 | 2008-03-13 | Worley Seth J | Pacing lead and method for pacing in the pericardial space |
US8036757B2 (en) | 2006-09-10 | 2011-10-11 | Seth Worley | Pacing lead and method for pacing in the pericardial space |
US8348999B2 (en) | 2007-01-08 | 2013-01-08 | California Institute Of Technology | In-situ formation of a valve |
US8133270B2 (en) | 2007-01-08 | 2012-03-13 | California Institute Of Technology | In-situ formation of a valve |
US20080167705A1 (en) * | 2007-01-10 | 2008-07-10 | Cook Incorporated | Short wire stent delivery system with splittable outer sheath |
US7967853B2 (en) | 2007-02-05 | 2011-06-28 | Boston Scientific Scimed, Inc. | Percutaneous valve, system and method |
US8470023B2 (en) | 2007-02-05 | 2013-06-25 | Boston Scientific Scimed, Inc. | Percutaneous valve, system, and method |
US11504239B2 (en) | 2007-02-05 | 2022-11-22 | Boston Scientific Scimed, Inc. | Percutaneous valve, system and method |
US9421083B2 (en) | 2007-02-05 | 2016-08-23 | Boston Scientific Scimed Inc. | Percutaneous valve, system and method |
US10226344B2 (en) | 2007-02-05 | 2019-03-12 | Boston Scientific Scimed, Inc. | Percutaneous valve, system and method |
US8828079B2 (en) | 2007-07-26 | 2014-09-09 | Boston Scientific Scimed, Inc. | Circulatory valve, system and method |
US11801091B2 (en) | 2007-11-16 | 2023-10-31 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US9877779B2 (en) | 2007-11-16 | 2018-01-30 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US10828097B2 (en) | 2007-11-16 | 2020-11-10 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US11331141B2 (en) | 2007-11-16 | 2022-05-17 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US10828098B2 (en) | 2007-11-16 | 2020-11-10 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US11633231B2 (en) | 2007-11-16 | 2023-04-25 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US9750569B2 (en) | 2007-11-16 | 2017-09-05 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US9603661B2 (en) | 2007-11-16 | 2017-03-28 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US9820810B2 (en) | 2007-11-16 | 2017-11-21 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US9585717B2 (en) | 2007-11-16 | 2017-03-07 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US10828095B2 (en) | 2007-11-16 | 2020-11-10 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US8932287B2 (en) | 2007-11-16 | 2015-01-13 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US9839474B2 (en) | 2007-11-16 | 2017-12-12 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US11304751B2 (en) | 2007-11-16 | 2022-04-19 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US11413091B2 (en) | 2007-11-16 | 2022-08-16 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US11751940B2 (en) | 2007-11-16 | 2023-09-12 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US10828096B2 (en) | 2007-11-16 | 2020-11-10 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US10499986B2 (en) | 2007-11-16 | 2019-12-10 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US11076913B2 (en) | 2007-11-16 | 2021-08-03 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US11432874B2 (en) | 2007-11-16 | 2022-09-06 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US8906011B2 (en) | 2007-11-16 | 2014-12-09 | Kardium Inc. | Medical device for use in bodily lumens, for example an atrium |
US7892276B2 (en) | 2007-12-21 | 2011-02-22 | Boston Scientific Scimed, Inc. | Valve with delayed leaflet deployment |
US8137394B2 (en) | 2007-12-21 | 2012-03-20 | Boston Scientific Scimed, Inc. | Valve with delayed leaflet deployment |
US8414641B2 (en) | 2007-12-21 | 2013-04-09 | Boston Scientific Scimed, Inc. | Valve with delayed leaflet deployment |
US9486345B2 (en) * | 2008-01-03 | 2016-11-08 | Covidien Lp | Methods and systems for placement of a stent adjacent an ostium |
US20090177259A1 (en) * | 2008-01-03 | 2009-07-09 | Bacchus Vascular, Inc. | Methods and systems for placement of a stent adjacent an ostium |
US8489172B2 (en) | 2008-01-25 | 2013-07-16 | Kardium Inc. | Liposuction system |
US9744038B2 (en) | 2008-05-13 | 2017-08-29 | Kardium Inc. | Medical device for constricting tissue or a bodily orifice, for example a mitral valve |
US8006594B2 (en) | 2008-08-11 | 2011-08-30 | Cardiac Dimensions, Inc. | Catheter cutting tool |
US20100094401A1 (en) * | 2008-10-10 | 2010-04-15 | William Cook Europe, Aps | Curvable stent-graft and apparatus and fitting method |
US10687941B2 (en) | 2009-10-01 | 2020-06-23 | Kardium Inc. | Medical device, kit and method for constricting tissue or a bodily orifice, for example, a mitral valve |
US10813758B2 (en) | 2009-10-01 | 2020-10-27 | Kardium Inc. | Medical device, kit and method for constricting tissue or a bodily orifice, for example, a mitral valve |
US9204964B2 (en) | 2009-10-01 | 2015-12-08 | Kardium Inc. | Medical device, kit and method for constricting tissue or a bodily orifice, for example, a mitral valve |
US9867703B2 (en) | 2009-10-01 | 2018-01-16 | Kardium Inc. | Medical device, kit and method for constricting tissue or a bodily orifice, for example, a mitral valve |
US20110106012A1 (en) * | 2009-10-29 | 2011-05-05 | Velarde Franz E | Sheath Introducer with Self-Anchoring Mechanism |
US10603022B2 (en) | 2010-06-07 | 2020-03-31 | Kardium Inc. | Closing openings in anatomical tissue |
US9918706B2 (en) | 2010-06-07 | 2018-03-20 | Kardium Inc. | Closing openings in anatomical tissue |
US9050066B2 (en) | 2010-06-07 | 2015-06-09 | Kardium Inc. | Closing openings in anatomical tissue |
US8940002B2 (en) | 2010-09-30 | 2015-01-27 | Kardium Inc. | Tissue anchor system |
US11350989B2 (en) | 2011-01-21 | 2022-06-07 | Kardium Inc. | Catheter system |
US9675401B2 (en) | 2011-01-21 | 2017-06-13 | Kardium Inc. | Enhanced medical device for use in bodily cavities, for example an atrium |
US11596463B2 (en) | 2011-01-21 | 2023-03-07 | Kardium Inc. | Enhanced medical device for use in bodily cavities, for example an atrium |
US11259867B2 (en) | 2011-01-21 | 2022-03-01 | Kardium Inc. | High-density electrode-based medical device system |
US10485608B2 (en) | 2011-01-21 | 2019-11-26 | Kardium Inc. | Catheter system |
US9492228B2 (en) | 2011-01-21 | 2016-11-15 | Kardium Inc. | Enhanced medical device for use in bodily cavities, for example an atrium |
US11399881B2 (en) | 2011-01-21 | 2022-08-02 | Kardium Inc. | Enhanced medical device for use in bodily cavities, for example an atrium |
US9526573B2 (en) | 2011-01-21 | 2016-12-27 | Kardium Inc. | Enhanced medical device for use in bodily cavities, for example an atrium |
US11896295B2 (en) | 2011-01-21 | 2024-02-13 | Kardium Inc. | High-density electrode-based medical device system |
US9452016B2 (en) | 2011-01-21 | 2016-09-27 | Kardium Inc. | Catheter system |
US9480525B2 (en) | 2011-01-21 | 2016-11-01 | Kardium, Inc. | High-density electrode-based medical device system |
US9486273B2 (en) | 2011-01-21 | 2016-11-08 | Kardium Inc. | High-density electrode-based medical device system |
US9492227B2 (en) | 2011-01-21 | 2016-11-15 | Kardium Inc. | Enhanced medical device for use in bodily cavities, for example an atrium |
US11607261B2 (en) | 2011-01-21 | 2023-03-21 | Kardium Inc. | Enhanced medical device for use in bodily cavities, for example an atrium |
US11298173B2 (en) | 2011-01-21 | 2022-04-12 | Kardium Inc. | Enhanced medical device for use in bodily cavities, for example an atrium |
US9072511B2 (en) | 2011-03-25 | 2015-07-07 | Kardium Inc. | Medical kit for constricting tissue or a bodily orifice, for example, a mitral valve |
US10058318B2 (en) | 2011-03-25 | 2018-08-28 | Kardium Inc. | Medical kit for constricting tissue or a bodily orifice, for example, a mitral valve |
US9668859B2 (en) | 2011-08-05 | 2017-06-06 | California Institute Of Technology | Percutaneous heart valve delivery systems |
USD777925S1 (en) | 2012-01-20 | 2017-01-31 | Kardium Inc. | Intra-cardiac procedure device |
USD777926S1 (en) | 2012-01-20 | 2017-01-31 | Kardium Inc. | Intra-cardiac procedure device |
US9198592B2 (en) | 2012-05-21 | 2015-12-01 | Kardium Inc. | Systems and methods for activating transducers |
US9259264B2 (en) | 2012-05-21 | 2016-02-16 | Kardium Inc. | Systems and methods for activating transducers |
US9532831B2 (en) | 2012-05-21 | 2017-01-03 | Kardium Inc. | Systems and methods for activating transducers |
US11672485B2 (en) | 2012-05-21 | 2023-06-13 | Kardium Inc. | Systems and methods for activating transducers |
US9011423B2 (en) | 2012-05-21 | 2015-04-21 | Kardium, Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US11633238B2 (en) | 2012-05-21 | 2023-04-25 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US10568576B2 (en) | 2012-05-21 | 2020-02-25 | Kardium Inc. | Systems and methods for activating transducers |
US11589821B2 (en) | 2012-05-21 | 2023-02-28 | Kardium Inc. | Systems and methods for activating transducers |
US9572509B2 (en) | 2012-05-21 | 2017-02-21 | Kardium Inc. | Systems and methods for activating transducers |
US10470826B2 (en) | 2012-05-21 | 2019-11-12 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US9693832B2 (en) | 2012-05-21 | 2017-07-04 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US10827977B2 (en) | 2012-05-21 | 2020-11-10 | Kardium Inc. | Systems and methods for activating transducers |
US9017321B2 (en) | 2012-05-21 | 2015-04-28 | Kardium, Inc. | Systems and methods for activating transducers |
US9888972B2 (en) | 2012-05-21 | 2018-02-13 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US9445862B2 (en) | 2012-05-21 | 2016-09-20 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US9980679B2 (en) | 2012-05-21 | 2018-05-29 | Kardium Inc. | Systems and methods for activating transducers |
US9439713B2 (en) | 2012-05-21 | 2016-09-13 | Kardium Inc. | Systems and methods for activating transducers |
US11690684B2 (en) | 2012-05-21 | 2023-07-04 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US11805974B2 (en) | 2012-05-21 | 2023-11-07 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US9017320B2 (en) | 2012-05-21 | 2015-04-28 | Kardium, Inc. | Systems and methods for activating transducers |
US10918446B2 (en) | 2012-05-21 | 2021-02-16 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US11154248B2 (en) | 2012-05-21 | 2021-10-26 | Kardium Inc. | Systems and methods for activating transducers |
US9744037B2 (en) | 2013-03-15 | 2017-08-29 | California Institute Of Technology | Handle mechanism and functionality for repositioning and retrieval of transcatheter heart valves |
US20150030499A1 (en) * | 2013-07-24 | 2015-01-29 | Injectinator, LLC | System and method for carpet-odor treatment |
US9517285B2 (en) * | 2013-07-24 | 2016-12-13 | Injectinator, LLC | System and method for carpet-odor treatment |
US10751006B2 (en) | 2014-11-17 | 2020-08-25 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US10368936B2 (en) | 2014-11-17 | 2019-08-06 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US11026637B2 (en) | 2014-11-17 | 2021-06-08 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US10722184B2 (en) | 2014-11-17 | 2020-07-28 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US11026638B2 (en) | 2014-11-17 | 2021-06-08 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US10758191B2 (en) | 2014-11-17 | 2020-09-01 | Kardium Inc. | Systems and methods for selecting, activating, or selecting and activating transducers |
US10390953B2 (en) | 2017-03-08 | 2019-08-27 | Cardiac Dimensions Pty. Ltd. | Methods and devices for reducing paravalvular leakage |
US11399939B2 (en) | 2017-03-08 | 2022-08-02 | Cardiac Dimensions Pty. Ltd. | Methods and devices for reducing paravalvular leakage |
US11648121B2 (en) | 2017-03-09 | 2023-05-16 | Medtronic Vascular, Inc. | Tension management devices for stented prosthesis delivery device |
CN110381888A (en) * | 2017-03-09 | 2019-10-25 | 美敦力瓦斯科尔勒公司 | The tension managing device of prosthesis delivery device for belt supporting frame |
US11701228B2 (en) | 2018-03-20 | 2023-07-18 | Medtronic Vascular, Inc. | Flexible canopy valve repair systems and methods of use |
US11285003B2 (en) | 2018-03-20 | 2022-03-29 | Medtronic Vascular, Inc. | Prolapse prevention device and methods of use thereof |
US11026791B2 (en) | 2018-03-20 | 2021-06-08 | Medtronic Vascular, Inc. | Flexible canopy valve repair systems and methods of use |
US11931261B2 (en) | 2018-03-20 | 2024-03-19 | Medtronic Vascular, Inc. | Prolapse prevention device and methods of use thereof |
US11766331B2 (en) | 2020-05-27 | 2023-09-26 | Politecnico Di Milano | Device and assembly to repair a heart valve |
US11596771B2 (en) | 2020-12-14 | 2023-03-07 | Cardiac Dimensions Pty. Ltd. | Modular pre-loaded medical implants and delivery systems |
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US20030078465A1 (en) | 2003-04-24 |
US20050197693A1 (en) | 2005-09-08 |
US7144363B2 (en) | 2006-12-05 |
US20050197694A1 (en) | 2005-09-08 |
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