US20100069849A1 - Percutaneous intravascular access to cardiac tissue - Google Patents

Percutaneous intravascular access to cardiac tissue Download PDF

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Publication number
US20100069849A1
US20100069849A1 US12/305,864 US30586407A US2010069849A1 US 20100069849 A1 US20100069849 A1 US 20100069849A1 US 30586407 A US30586407 A US 30586407A US 2010069849 A1 US2010069849 A1 US 2010069849A1
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heart
needle
targeted tissue
distal end
wall
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Ghassan S. Kassab
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CVDevices LLC
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CVDevices LLC
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Assigned to CVDEVICES, LLC reassignment CVDEVICES, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: KASSAB, GHASSAN S., NAVIA, JOSE A., SR.
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    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0587Epicardial electrode systems; Endocardial electrodes piercing the pericardium
    • A61N1/0592Introducing the lead through the pericardium with a needle
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    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
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    • A61B2017/00575Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
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    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
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    • A61M2210/00Anatomical parts of the body
    • A61M2210/12Blood circulatory system
    • A61M2210/125Heart

Definitions

  • Ischemic heart disease or coronary heart disease, kills more Americans per year than any other single cause. Indeed, in 2004, one in every five deaths in the United States resulted from ischemic heart disease. It has been estimated that the disease will cost $151.6 billion in 2007.
  • Ischemic heart disease is generally characterized by a diminished flow of blood to the myocardium and is often treated using drug therapy.
  • many of the available drugs may be administered systemically, local drug delivery (“LDD”) directly to the heart can result in higher local drug concentrations with fewer systemic side effects, thereby leading to improved therapeutic outcomes.
  • LDD local drug delivery
  • Cardiac drugs may be delivered locally via catheter passing through the blood vessels to the inside of the heart.
  • endoluminal drug delivery has several shortcomings, such as: (1) inconsistent delivery, (2) low efficiency of localization, and (3) relatively rapid washout into the circulation.
  • drugs may be delivered directly into the pericardial space, which surrounds the external surface of the heart.
  • the pericardial space is a cavity formed between the heart and the relatively stiff pericardial sac that encases the heart.
  • a catheter may be used to inject a drug into the pericardial space for local administration to the myocardial and coronary tissues.
  • Drug delivery methods that supply the agent to the heart via the pericardial space offer several advantages over endoluminal delivery, including: (1) enhanced consistency and (2) prolonged exposure of the drug to the cardiac tissue.
  • drugs are delivered into the pericardial space either by the percutaneous transventricular method or by the transthoracic approach.
  • the percutaneous transventricular method involves the controlled penetration of a catheter through the ventricular myocardium to the pericardial space.
  • the transthoracic approach involves accessing the pericardial space from outside the heart using a sheathed needle with a suction tip to grasp the pericardium, pulling it away from the myocardium to enlarge the pericardial space, and injecting the drug into the space with the needle.
  • the only approved non-surgical means for accessing the pericardial space include the subxiphoid and the ultrasound-guided apical and parasternal needle catheter techniques, and each methods involves a transthoracic approach.
  • a sheathed needle with a suction tip is advanced from a subxiphoid position into the mediastinum under fluoroscopic guidance.
  • the catheter is positioned onto the anterior outer surface of the pericardial sac, and the suction tip is used to grasp the pericardium and pull it away from the heart tissue, thereby creating additional clearance between the pericardial sac and the heart.
  • the additional clearance tends to decrease the likelihood that the myocardium will be inadvertently punctured when the pericardial sac is pierced.
  • a substance may be delivered to a specifically targeted area of the interior of a wall of the heart (i.e., “targeted tissue”).
  • targeted tissue a specifically targeted area of the interior of a wall of the heart
  • Certain other embodiments provide for access to the tissue on the external surface of the heart by delivering a substance to the pericardial space using a non-surgical, percutaneous route that is both rapid and safe. Indeed, many of the disclosed embodiments avoid percutaneous subxiphoid puncture and hence the associated increased risk of right ventricular lesions, as well as the anterior thoracotomy for pericardial window procedure.
  • At least some of the embodiments disclosed herein include a system for accessing the tissue of a heart comprising an engagement catheter having a proximal end, a distal end, and first and second lumens extending between the proximal end and the distal end.
  • a vacuum port is located at the proximal end of the engagement catheter and is operatively connected to the first lumen of the engagement catheter and capable of operative connection to a vacuum source.
  • the first lumen of the engagement catheter includes a suction port located at or near the catheter's distal end, and the suction port is configured to removably attach to a targeted tissue on the interior of a wall of the heart.
  • the wall may be an atrial wall or a wall of the atrial appendage.
  • the suction port is capable of forming a reversible seal with the targeted tissue when the vacuum source is operatively attached to the vacuum port, and the system is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds the heart by retracting the targeted tissue away from the pericardial sac.
  • the system also includes a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, and the delivery catheter may be configured to be inserted into the second lumen of the engagement catheter.
  • a needle may be located at the distal end of the delivery catheter, and the needle may include a pressure tip or a needle wire.
  • the delivery catheter may include a first lumen for delivering a fluid to the pericardial space.
  • the delivery catheter may be configured to fit within the second lumen of the engagement catheter such that the needle is positioned to be capable of piercing the targeted tissue when the suction port is attached to the targeted tissue, and such that, when the tissue is pierced, access to the pericardial space is achieved.
  • the engagement catheter also has, in fluid communication with its second lumen, an injection channel that is configured to administer a fluid to the targeted tissue.
  • the system may include a fluid, such as an adhesive, for administration to the targeted tissue through the injection channel.
  • the injection channel may be formed along the length of the engagement catheter, may have at its distal end at least one opening for administering a fluid to the heart tissue, and may be capable of operable attachment to an external fluid source at the proximal end of the injection channel such that fluid from the external fluid source can flow, through the injection channel to the targeted tissue when the external fluid source is operatively attached to the injection channel.
  • the injection channel is ring-shaped.
  • an engagement catheter to be used with a vacuum source in accessing heart tissue Such embodiments include an elongated tube comprising a proximal end, a distal end, an outer wall positioned circumferentially along the length of the tube, and an inner wall positioned circumferentially along the length of the tube, wherein the outer wall and the inner wall form at least one suction channel along the length of the tube between the outer wall and the inner wall; a vacuum port in communication with the proximal end of the tube, the vacuum port being operatively connected to the at least one suction channel and capable of operative connection to the vacuum source; and a suction port in communication with the at least one suction channel at the distal end of the tube.
  • the suction port is configured to removably attach to targeted tissue on the interior of a wall of the heart and is capable of forming a reversible seal with the heart wall when the vacuum source is operatively attached to the vacuum port.
  • the engagement catheter is capable of enlarging the pericardial space between the heart and the pericardial sac.
  • Certain embodiments include at least one internal lumen support positioned within the suction channel and attached to the outer wall and the inner wall.
  • Each internal lumen support may extend from the distal end of the tube along at least a substantial portion of the length of the tube.
  • the lumen supports form two suction channels.
  • an engagement catheter disclosed herein have an injection channel formed along the length of the tube, the injection channel having at its distal end at least one opening for administering a fluid to the targeted tissue.
  • the injection channel is capable of operable attachment to an external fluid source at the proximal end of the injection channel such that fluid from the external fluid source can flow through the injection channel to the heart tissue when the external fluid source is operatively attached to the injection channel.
  • a delivery catheter for use in accessing heart tissue.
  • Some delivery catheter embodiments include an elongated hollow tube comprising a proximal end, a distal end, a lumen, a needle extending from the distal end of the tube, and a security notch formed circumferentially around the needle.
  • the security notch is configured to prevent over-perforation of the needle when piercing a wall of the heart into the pericardial space.
  • the tube of some embodiments of delivery catheter further includes one or more openings for administering a fluid to an external surface of the heart located in the pericardial space, such that the at least one opening is in fluid communication with the lumen of the tube.
  • an elongated guide wire may be placed inside the lumen of the tube and inserted into the pericardial space.
  • Certain embodiments include the steps of providing a system as disclosed herein; inserting an engagement catheter into the body such that the distal end of the engagement catheter is positioned inside the heart and the suction port is in contact with the interior of a wall of the heart; operatively connecting a vacuum source to the vacuum port such that the suction port is reversibly attached to a targeted tissue on the interior of a wall of the heart; inserting the delivery catheter into the second lumen of the engagement catheter; piercing the targeted tissue with the needle; and administering a substance into the pericardial space.
  • the method also includes the step of administering a substance to the targeted tissue after withdrawal of the needle, and the substance may include an adhesive for sealing a puncture wound in the targeted tissue.
  • Certain other embodiments include the steps of extending into a blood vessel an elongated hollow tube having a proximal end, a distal end, and at least one lumen, such that the distal end of the tube is in contact with the interior of a wall of the heart; aspirating a targeted tissue on the interior of a wall of the heart such that the wall of the heart is retracted away from a pericardial sac surrounding the heart to enlarge a pericardial space between the pericardial sac and the wall of the heart; delivering a fluid onto the targeted tissue; and removing the elongated tube from the body.
  • Such embodiments may further include the steps of inserting through a lumen of the elongated tube a delivery catheter having a proximal end, a distal end, and a needle located at the distal end, such that the needle is located within the heart; inserting the needle into the targeted tissue on the interior of the wall of the heart; and injecting a fluid into the pericardial space such that the fluid contacts the exterior of the heart within the pericardial space.
  • the needle is withdrawn after puncture, and the distal end of a guide wire is inserted through the lumen of the delivery catheter and into the pericardial space. The delivery catheter may then be inserted into the pericardial space.
  • FIG. 1A shows an embodiment of an engagement catheter and an embodiment of a delivery catheter as disclosed herein;
  • FIG. 1B shows a percutaneous intravascular pericardial delivery using another embodiment of an engagement catheter and another embodiment of a delivery catheter as disclosed herein;
  • FIG. 2A shows a percutaneous intravascular technique for accessing the pericardial space through a right atrial wall or atrial appendage using the engagement and delivery catheters shown in FIG. 1A ;
  • FIG. 2B shows the embodiment of an engagement catheter shown in FIG. 2A ;
  • FIG. 2C shows another view of the distal end of the engagement catheter embodiment shown in FIGS. 2A and 2B ;
  • FIG. 3A shows removal of an embodiment of a catheter as disclosed herein
  • FIG. 3B shows the resealing of a puncture according to an embodiment as disclosed herein;
  • FIG. 4A to 4C show a closure of a hole in the atrial wall using an embodiment as disclosed herein;
  • FIG. 5A shows an embodiment of an engagement catheter as disclosed herein
  • FIG. 5B shows a cross-sectional view of the proximal end of the engagement catheter shown in FIG. 5A ;
  • FIG. 5C shows a cross-sectional view of the distal end of the engagement catheter shown in FIG. 5A ;
  • FIG. 5D shows the engagement catheter shown in FIG. 5A approaching a heart wall from inside of the heart
  • FIG. 6A shows an embodiment of a delivery catheter as disclosed herein
  • FIG. 6B shows a close-up view of the needle shown in FIG. 6A ;
  • FIG. 6C shows a cross-sectional view of the needle shown in FIGS. 6A and 6B .
  • the disclosed embodiments include devices, systems, and methods useful for accessing various tissues of the heart from inside the heart.
  • various embodiments provide for percutaneous, intravascular access into the pericardial space through an atrial wall or the wall of an atrial appendage.
  • the heart wall is aspirated and retracted from the pericardial sac to increase the pericardial space between the heart and the sac and thereby facilitate access into the space.
  • the atrial wall and atrial appendage are rather soft and deformable.
  • suction of the atrial wall or atrial appendage can provide significantly more clearance of the cardiac structure from the pericardium as compared to suction of the pericardium.
  • navigation from the intravascular region (inside of the heart) provides more certainty of position of vital cardiac structures than does intrathoracic access (outside of the heart).
  • Access to the pericardial space may be used for identification of diagnostic markers in the pericardial fluid; for pericardiocentesis; and for administration of therapeutic factors with angiogenic, myogenic, and antiarrhythmic potential.
  • epicardial pacing leads may be delivered via the pericardial space, and an ablation catheter may be used on the epicardial tissue from the pericardial space.
  • catheter system 10 includes an engagement catheter 20 , a delivery catheter 30 , and a needle 40 .
  • engagement catheter 20 has a lumen through which delivery catheter 30 has been inserted
  • delivery catheter 30 has a lumen through which needle 40 has been inserted.
  • Delivery catheter 30 also has a number of openings 50 that can be used to transmit fluid from the lumen of the catheter to the heart tissue in close proximity to the distal end of the catheter.
  • engagement catheter 20 includes a vacuum channel 60 used for suction of a targeted tissue 65 in the heart and an injection channel 70 used for infusion of substances to targeted tissue 65 , including, for example, a biological or non-biological degradable adhesive.
  • injection channel 70 is ring-shaped, which tends to provide relatively even dispersal of the infused substance over the targeted tissue, but other shapes of injection channels may be suitable.
  • a syringe 80 is attached to injection channel 70 for delivery of the appropriate substances to injection channel 70
  • a syringe 90 is attached to vacuum channel 60 through a vacuum port (not shown) at the proximal end of engagement catheter 20 to provide appropriate suction through vacuum channel 60 .
  • a suction port 95 is attached to vacuum channel 60 for contacting targeted tissue 65 , such that suction port 95 surrounds targeted tissue 65 , which is thereby encompassed within the circumference of suction port 95 .
  • syringe 90 is shown in FIG. 2B as the vacuum source providing suction for engagement catheter 20 , other types of vacuum sources may be used, such as a controlled vacuum system providing specific suction pressures.
  • syringe 80 serves as the external fluid source in the embodiment shown in FIG. 2B , but other external fluid sources may be used.
  • a route of entry for use of various embodiments disclosed herein is through the jugular or femoral vein to the superior or inferior vena cavae, respectively, to the right atrial wall or atrial appendage (percutaneously) to the pericardial sac (through puncture).
  • an engagement catheter 100 is placed via standard approach into the jugular or femoral vein.
  • the catheter which may be 4 or 5 Fr., is positioned under fluoroscopic or echocardiographic guidance into the right atrial appendage 110 .
  • Suction is initiated to aspirate a portion of atrial appendage 110 away from the pericardial sac 120 that surrounds the heart.
  • aspiration of the heart tissue is evidenced when no blood can be pulled back through engagement catheter 100 and, if suction pressure is being measured, when the suction pressure gradually increases.
  • a delivery catheter 130 is then inserted through a lumen of engagement catheter 100 .
  • a small perforation can be made in the aspirated atrial appendage 110 with a needle such as needle 40 , as shown in FIGS. 1A and 2A .
  • a guide wire (not shown) can then be advanced through delivery catheter 130 into the pericardial space to secure the point of entry 125 through the atrial appendage and guide further insertion of delivery catheter 130 or another catheter.
  • Flouroscopy or echocardiogram can be used to confirm the position of the catheter in the pericardial space.
  • a pressure tip needle can sense the pressure and measure the pressure change from the atrium (about 10 mmHg) to the pericardial space (about 2 mmHg). This is particularly helpful for transeptal access where puncture of arterial structures (e.g., the aorta) can be diagnosed and sealed with an adhesive, as described in more detail below.
  • CO2 gas can be delivered through a catheter, such as delivery catheter 130 , into the pericardial space to create additional space between the pericardial sac and the heart surface.
  • the catheter system shown in FIG. 1B is retrieved by pull back through the route of entry.
  • the puncture of the targeted tissue in the heart e.g., the right atrial appendage as shown in FIG. 3A
  • the retrieval of the catheter may be combined with a sealing of the tissue in one of several ways: (1) release of a tissue adhesive or polymer 75 via injection channel 70 to seal off the puncture hole, as shown in FIG. 3B ; (2) release of an inner clip or mechanical stitch to close off the hole from the inside of the cavity; or (3) mechanical closure of the heart with a sandwich type mechanical device that approaches the hole from both sides of the wall (see FIGS.
  • closure may be accomplished by using, for example, a biodegradable adhesive material (e.g., fibrin glue or cyanomethacrylate), a magnetic system, or an umbrella-shaped nitinol stent.
  • a biodegradable adhesive material e.g., fibrin glue or cyanomethacrylate
  • a magnetic system e.g., a magnetospray
  • an umbrella-shaped nitinol stent e.g., a magnetic system
  • FIG. 3B An example of the closure of a hole in the atrium is shown in FIG. 3B .
  • Engagement catheter 20 is attached to targeted tissue 95 using suction through suction port 60 .
  • Tissue adhesive 75 is injected through injection channel 70 to coat and seal the puncture wound in targeted tissue 95 .
  • Engagement catheter 20 is then withdrawn, leaving a plug of tissue adhesive 75 attached to the atrial wall or atrial appendage.
  • FIGS. 4A , 4 B, and 4 C Another example for sealing the puncture wound in the atrial wall or appendage is shown in FIGS. 4A , 4 B, and 4 C.
  • a sandwich-type closure having an external cover 610 and an internal cover 620 , is inserted through the lumen of engagement catheter 600 , which is attached to the targeted tissue of an atrial wall 630 .
  • Each of external and internal covers 610 and 620 is similar to an umbrella in that it can be inserted through a catheter in its folded configuration and expanded once it is outside of the catheter.
  • external cover 610 is deployed (in its expanded configuration) on the outside of the atrial wall to seal a puncture wound in the targeted tissue.
  • Internal cover 620 is delivered through engagement catheter 600 (in its folded configuration), as shown in FIGS.
  • FIGS. 5A , 5 B, 5 C, and 5 D show another embodiment of an engagement catheter as disclosed herein.
  • Engagement catheter 700 is an elongated tube having a proximal end 710 and a distal end 720 , as well as two lumens 730 , 740 extending between proximal end 710 and distal end 720 .
  • Lumens 730 , 740 are formed by concentric inner wall 750 and outer wall 760 , as particularly shown in FIGS. 5B and 5C .
  • engagement catheter 700 includes a vacuum port 770 , which is attached to lumen 730 so that a vacuum source can be attached to vacuum port 770 to create suction in lumen 730 , thereby forming a suction channel.
  • a suction port 780 is attached to lumen 730 so that suction port 780 can be placed in contact with heart tissue 775 (see FIG. 5D ) for aspirating the tissue, thereby forming a vacuum seal between suction port 780 and tissue 775 when the vacuum source is attached and engaged.
  • the vacuum seal enables suction port 780 to grip, stabilize, and retract tissue 775 .
  • attaching a suction port to an interior atrial wall using a vacuum source enables the suction port to retract the atrial wall from the pericardial sac surrounding the heart, which enlarges the pericardial space between the atrial wall and the pericardial sac.
  • two internal lumen supports 810 , 820 are located within lumen 730 and are attached to inner wall 750 and outer wall 760 to provide support to the walls. These lumen supports divide lumen 730 into two suction channels. Although internal lumen supports 810 , 820 extend from distal end 720 of catheter 700 along a substantial portion of the length of catheter 700 , internal lumen supports 810 , 820 may or may not span the entire length of catheter 700 . Indeed, as shown in FIGS. 5A , 5 B, and 5 C, internal lumen supports 810 , 820 do not extend to proximal end 710 to ensure that the suction from the external vacuum source is distributed relatively evenly around the circumference of catheter 700 . Although the embodiment shown in FIG. 5C includes two internal lumen supports, other embodiments may have just one internal support or even three or more such supports.
  • FIG. 5D shows engagement catheter 700 approaching heart tissue 775 for attachment thereto. It is important for the clinician performing the procedure to know when the suction port has engaged the tissue of the atrial wall or the atrial appendage. For example, in reference to FIG. 5D , it is clear that suction port 780 has not fully engaged tissue 775 such that a seal is formed. However, because suction port 780 is not usually seen during the procedure, the clinician may determine when the proper vacuum seal between the atrial tissue and the suction port has been made by monitoring the amount of blood that is aspirated, by monitoring the suction pressure with a pressure sensor/regulator, or both.
  • the suction can be activated through lumen 730 .
  • a certain level of suction e.g., 10 mmHg
  • a pressure sensor/regulator As long as catheter 700 does not engage the wall, some blood will be aspirated into the catheter and the suction pressure will remain the same. However, when catheter 700 engages or attaches to the wall of the heart (depicted as tissue 775 in FIG. 5D ), minimal blood is aspirated and the suction pressure will start to gradually increase. Each of these signs can alert the clinician (through alarm or other means) as an indication of engagement.
  • the pressure regulator is then able to maintain the suction pressure at a preset value to prevent over-suction of the tissue.
  • An engagement catheter such as engagement catheter 700
  • lumen 740 shown in FIGS. 5A and 5C includes an injection channel 790 at distal end 720 .
  • Injection channel 790 dispenses to the targeted tissue a substance flowing through lumen 740 .
  • injection channel 790 is the distal end of lumen 740 .
  • the injection channel may be ring-shaped (see FIG. 2C ) or have some other suitable configuration.
  • Substances that can be locally administered with an engagement catheter include preparations for gene or cell therapy, drugs, and adhesives that are safe for use in the heart.
  • the proximal end of lumen 740 has a fluid port 800 , which is capable of attachment to an external fluid source for supply of the fluid to be delivered to the targeted tissue.
  • an adhesive may be administered to the targeted tissue by the engagement catheter for sealing the puncture wound left by the needle withdrawn from the targeted tissue.
  • a delivery catheter 850 comprising an elongated hollow tube 880 having a proximal end 860 , a distal end 870 , and a lumen 885 along the length of the catheter. Extending from distal end 870 is a hollow needle 890 in communication with lumen 885 . Needle 890 is attached to distal end 870 in the embodiment of FIGS. 6A , 6 B, and 6 C, but, in other embodiments, the needle may be removably attached to, or otherwise located at, the distal end of the catheter (see FIG. 1A ). In the embodiment shown in FIGS.
  • the junction i.e., site of attachment
  • the clinician when a clinician inserts needle 890 through an atrial wall to gain access to the pericardial space, the clinician will not, under normal conditions, unintentionally perforate the pericardial sac with needle 890 because the larger diameter of hollow tube 880 (as compared to that of needle 890 ) at security notch 910 hinders further needle insertion.
  • security notch 910 is formed by the junction of hollow tube 880 and needle 890 in the embodiment shown in FIGS.
  • a security notch may include a band, ring, or similar device that is attached to the needle a suitable distance from the tip of the needle.
  • a security notch 910 other security notch embodiments hinder insertion of the needle past the notch itself by presenting a larger profile than the profile of the needle such that the notch does not easily enter the hole in the tissue caused by entry of the needle.
  • the delivery catheter can be connected to a pressure transducer to measure pressure at the tip of the needle. Because the pressure is lower and much less pulsatile in the pericardial space than in the atrium, the clinician can recognize immediately when the needle passes through the atrial tissue into the pericardial space.
  • needle 890 may be connected to a strain gauge 915 as part of the catheter assembly.
  • tissue not shown
  • needle 890 will be deformed.
  • the deformation will be transmitted to strain gauge 915 and an electrical signal will reflect the deformation (through a classical wheatstone bridge), thereby alerting the clinician.
  • Such confirmation of the puncture of the wall can prevent over-puncture and can provide additional control of the procedure.
  • a delivery catheter such as catheter 850 shown in FIGS. 6A , 6 B, and 6 C
  • an engagement catheter such as catheter 700 shown in FIGS. 5A , 5 B, 5 C, and 5 D
  • engagement catheter 700 may be inserted into the vascular system and advanced such that the distal end of the engagement catheter is within the atrium.
  • the engagement catheter may be attached to the targeted tissue on the interior of a wall of the atrium using a suction port as disclosed herein.
  • a standard guide wire may be inserted through the lumen of the delivery catheter as the delivery catheter is inserted through the inner lumen of the engagement catheter, such as lumen 740 shown in FIGS.
  • Use of the guide wire enables more effective navigation of the delivery catheter 850 and prevents the needle 890 from damaging the inner wall 750 of the engagement catheter 700 .
  • the tip of the delivery catheter with the protruding guide wire reaches the atrium, the wire is pulled back, and the needle is pushed forward to perforate the targeted tissue.
  • the guide wire is then advanced through the perforation into the pericardial space, providing access to the pericardial space through the atrial wall.
  • lumen 885 of delivery catheter 850 may be used for delivering fluid into the pericardial space after needle 890 is inserted through the atrial wall or the atrial appendage.
  • a guide wire (not shown) may be inserted through needle lumen 900 into the pericardial space to maintain access through the atrial wall or appendage. Fluid may then be introduced to the pericardial space in a number of ways. For example, after the needle punctures the atrial wall or appendage, the needle is generally withdrawn. If the needle is permanently attached to the delivery catheter, as in the embodiment shown in FIGS. 6A and 6B , then delivery catheter 850 would be withdrawn and another delivery catheter (without an attached needle) would be introduced over the guide wire into the pericardial space. Fluid may then be introduced into the pericardial space through the lumen of the second delivery catheter.
  • the needle is not attached to the delivery catheter, but instead may be a needle wire (see FIG. 1A ).
  • the needle is withdrawn through the lumen of the delivery catheter, and the delivery catheter may be inserted over the guide wire into the pericardial space. Fluid is then introduced into the pericardial space through the lumen of the delivery catheter.
  • the various embodiments disclosed herein may be used by clinicians, for example: (1) to deliver genes, cells, drugs, etc.; (2) to provide catheter access for epicardial stimulation; (3) to evacuate fluids acutely (e.g., in cases of pericardial tampondae) or chronically (e.g., to alleviate effusion caused by chronic renal disease, cancer, etc.); (4) to perform transeptal puncture and delivery of a catheter through the left atrial appendage for electrophysiological therapy, biopsy, etc.; (5) to deliver a magnetic glue or ring through the right atrial appendage to the aortic root to hold a percutaneous aortic valve in place; (6) to deliver a catheter for tissue ablation, e.g., to the pulmonary veins, or right atrial and epicardial surface of the heart for atrial and ventricular arrythmias; (7) to deliver and place epicardial, right atrial, and right and left ventricle pacing leads; (8) to occlude the left atrial app
  • the disclosure may have presented a method and/or process as a particular sequence of steps.
  • the method or process should not be limited to the particular sequence of steps described.
  • other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations on the claims.
  • the claims directed to a method and/or process should not be limited to the performance of their steps in the order written, and one skilled in the art can readily appreciate that the sequences may be varied and still remain within the spirit and scope of the present invention.

Abstract

Devices, systems, and methods for accessing the internal and external tissues of the heart are disclosed. At least some of the embodiments disclosed herein provide access to the external surface of the heart through the pericardial space for localized delivery of substances to the heart tissue. In addition, various disclosed embodiments provide access to the internal surface of the heart for aspiration and delivery of substances to a targeted region without disturbing or interfering with nearby structures or surfaces.

Description

  • This U.S. Utility patent application claims priority to U.S. Provisional Patent Application Ser. No. 60/914,452, filed Apr. 27, 2007, and U.S. Provisional Patent Application Ser. No. 60/817,421, filed Jun. 30, 2006.
  • BACKGROUND
  • Ischemic heart disease, or coronary heart disease, kills more Americans per year than any other single cause. Indeed, in 2004, one in every five deaths in the United States resulted from ischemic heart disease. It has been estimated that the disease will cost $151.6 billion in 2007.
  • Ischemic heart disease is generally characterized by a diminished flow of blood to the myocardium and is often treated using drug therapy. Although many of the available drugs may be administered systemically, local drug delivery (“LDD”) directly to the heart can result in higher local drug concentrations with fewer systemic side effects, thereby leading to improved therapeutic outcomes.
  • Cardiac drugs may be delivered locally via catheter passing through the blood vessels to the inside of the heart. However, endoluminal drug delivery has several shortcomings, such as: (1) inconsistent delivery, (2) low efficiency of localization, and (3) relatively rapid washout into the circulation.
  • To overcome such shortcomings, drugs may be delivered directly into the pericardial space, which surrounds the external surface of the heart. The pericardial space is a cavity formed between the heart and the relatively stiff pericardial sac that encases the heart. Although the pericardial space is usually quite small because the pericardial sac and the heart are in such close contact, a catheter may be used to inject a drug into the pericardial space for local administration to the myocardial and coronary tissues. Drug delivery methods that supply the agent to the heart via the pericardial space offer several advantages over endoluminal delivery, including: (1) enhanced consistency and (2) prolonged exposure of the drug to the cardiac tissue.
  • In current practice, drugs are delivered into the pericardial space either by the percutaneous transventricular method or by the transthoracic approach. The percutaneous transventricular method involves the controlled penetration of a catheter through the ventricular myocardium to the pericardial space. The transthoracic approach involves accessing the pericardial space from outside the heart using a sheathed needle with a suction tip to grasp the pericardium, pulling it away from the myocardium to enlarge the pericardial space, and injecting the drug into the space with the needle.
  • Clinically, the only approved non-surgical means for accessing the pericardial space include the subxiphoid and the ultrasound-guided apical and parasternal needle catheter techniques, and each methods involves a transthoracic approach. In the subxiphoid method, a sheathed needle with a suction tip is advanced from a subxiphoid position into the mediastinum under fluoroscopic guidance. The catheter is positioned onto the anterior outer surface of the pericardial sac, and the suction tip is used to grasp the pericardium and pull it away from the heart tissue, thereby creating additional clearance between the pericardial sac and the heart. The additional clearance tends to decrease the likelihood that the myocardium will be inadvertently punctured when the pericardial sac is pierced.
  • Although this technique works well in the normal heart, there are major limitations in diseased or dilated hearts—the very hearts for which drug delivery is most needed. When the heart is enlarged, the pericardial space is significantly smaller and the risk of puncturing the right ventricle or other cardiac structures is increased. Additionally, because the pericardium is a very stiff membrane, the suction on the pericardium provides little deformation of the pericardium and, therefore, very little clearance of the pericardium from the heart.
  • Thus, there is need for an efficient, easy to use, and relatively inexpensive technique that can be used to access the heart for local delivery of therapeutic and diagnostic substances.
  • BRIEF SUMMARY
  • Various embodiments disclosed herein relate to systems, devices, and methods for accessing specific tissues of the heart and for delivering substances to the cardiac tissue. For example, using certain embodiments, a substance may be delivered to a specifically targeted area of the interior of a wall of the heart (i.e., “targeted tissue”). Certain other embodiments provide for access to the tissue on the external surface of the heart by delivering a substance to the pericardial space using a non-surgical, percutaneous route that is both rapid and safe. Indeed, many of the disclosed embodiments avoid percutaneous subxiphoid puncture and hence the associated increased risk of right ventricular lesions, as well as the anterior thoracotomy for pericardial window procedure.
  • At least some of the embodiments disclosed herein include a system for accessing the tissue of a heart comprising an engagement catheter having a proximal end, a distal end, and first and second lumens extending between the proximal end and the distal end. A vacuum port is located at the proximal end of the engagement catheter and is operatively connected to the first lumen of the engagement catheter and capable of operative connection to a vacuum source. The first lumen of the engagement catheter includes a suction port located at or near the catheter's distal end, and the suction port is configured to removably attach to a targeted tissue on the interior of a wall of the heart. The wall may be an atrial wall or a wall of the atrial appendage. The suction port is capable of forming a reversible seal with the targeted tissue when the vacuum source is operatively attached to the vacuum port, and the system is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds the heart by retracting the targeted tissue away from the pericardial sac.
  • The system also includes a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, and the delivery catheter may be configured to be inserted into the second lumen of the engagement catheter. A needle may be located at the distal end of the delivery catheter, and the needle may include a pressure tip or a needle wire. In some embodiments, the delivery catheter may include a first lumen for delivering a fluid to the pericardial space. Further, the delivery catheter may be configured to fit within the second lumen of the engagement catheter such that the needle is positioned to be capable of piercing the targeted tissue when the suction port is attached to the targeted tissue, and such that, when the tissue is pierced, access to the pericardial space is achieved.
  • In various embodiments, the engagement catheter also has, in fluid communication with its second lumen, an injection channel that is configured to administer a fluid to the targeted tissue. The system may include a fluid, such as an adhesive, for administration to the targeted tissue through the injection channel. The injection channel may be formed along the length of the engagement catheter, may have at its distal end at least one opening for administering a fluid to the heart tissue, and may be capable of operable attachment to an external fluid source at the proximal end of the injection channel such that fluid from the external fluid source can flow, through the injection channel to the targeted tissue when the external fluid source is operatively attached to the injection channel. In some embodiments, the injection channel is ring-shaped.
  • Also disclosed herein are embodiments of an engagement catheter to be used with a vacuum source in accessing heart tissue. Such embodiments include an elongated tube comprising a proximal end, a distal end, an outer wall positioned circumferentially along the length of the tube, and an inner wall positioned circumferentially along the length of the tube, wherein the outer wall and the inner wall form at least one suction channel along the length of the tube between the outer wall and the inner wall; a vacuum port in communication with the proximal end of the tube, the vacuum port being operatively connected to the at least one suction channel and capable of operative connection to the vacuum source; and a suction port in communication with the at least one suction channel at the distal end of the tube. The suction port is configured to removably attach to targeted tissue on the interior of a wall of the heart and is capable of forming a reversible seal with the heart wall when the vacuum source is operatively attached to the vacuum port. When the suction port is attached to the targeted tissue, the engagement catheter is capable of enlarging the pericardial space between the heart and the pericardial sac.
  • Certain embodiments include at least one internal lumen support positioned within the suction channel and attached to the outer wall and the inner wall. Each internal lumen support may extend from the distal end of the tube along at least a substantial portion of the length of the tube. In embodiments having two internal lumen supports, the lumen supports form two suction channels.
  • At least some of the embodiments of an engagement catheter disclosed herein have an injection channel formed along the length of the tube, the injection channel having at its distal end at least one opening for administering a fluid to the targeted tissue. The injection channel is capable of operable attachment to an external fluid source at the proximal end of the injection channel such that fluid from the external fluid source can flow through the injection channel to the heart tissue when the external fluid source is operatively attached to the injection channel.
  • Various embodiments disclosed herein include a delivery catheter for use in accessing heart tissue. Some delivery catheter embodiments include an elongated hollow tube comprising a proximal end, a distal end, a lumen, a needle extending from the distal end of the tube, and a security notch formed circumferentially around the needle. The security notch is configured to prevent over-perforation of the needle when piercing a wall of the heart into the pericardial space. The tube of some embodiments of delivery catheter further includes one or more openings for administering a fluid to an external surface of the heart located in the pericardial space, such that the at least one opening is in fluid communication with the lumen of the tube. In at least some embodiments, an elongated guide wire may be placed inside the lumen of the tube and inserted into the pericardial space.
  • Also disclosed herein are various methods for accessing heart tissue. Certain embodiments include the steps of providing a system as disclosed herein; inserting an engagement catheter into the body such that the distal end of the engagement catheter is positioned inside the heart and the suction port is in contact with the interior of a wall of the heart; operatively connecting a vacuum source to the vacuum port such that the suction port is reversibly attached to a targeted tissue on the interior of a wall of the heart; inserting the delivery catheter into the second lumen of the engagement catheter; piercing the targeted tissue with the needle; and administering a substance into the pericardial space. In some embodiments, the method also includes the step of administering a substance to the targeted tissue after withdrawal of the needle, and the substance may include an adhesive for sealing a puncture wound in the targeted tissue.
  • Certain other embodiments include the steps of extending into a blood vessel an elongated hollow tube having a proximal end, a distal end, and at least one lumen, such that the distal end of the tube is in contact with the interior of a wall of the heart; aspirating a targeted tissue on the interior of a wall of the heart such that the wall of the heart is retracted away from a pericardial sac surrounding the heart to enlarge a pericardial space between the pericardial sac and the wall of the heart; delivering a fluid onto the targeted tissue; and removing the elongated tube from the body. Such embodiments may further include the steps of inserting through a lumen of the elongated tube a delivery catheter having a proximal end, a distal end, and a needle located at the distal end, such that the needle is located within the heart; inserting the needle into the targeted tissue on the interior of the wall of the heart; and injecting a fluid into the pericardial space such that the fluid contacts the exterior of the heart within the pericardial space. In at least some embodiments, the needle is withdrawn after puncture, and the distal end of a guide wire is inserted through the lumen of the delivery catheter and into the pericardial space. The delivery catheter may then be inserted into the pericardial space.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1A shows an embodiment of an engagement catheter and an embodiment of a delivery catheter as disclosed herein;
  • FIG. 1B shows a percutaneous intravascular pericardial delivery using another embodiment of an engagement catheter and another embodiment of a delivery catheter as disclosed herein;
  • FIG. 2A shows a percutaneous intravascular technique for accessing the pericardial space through a right atrial wall or atrial appendage using the engagement and delivery catheters shown in FIG. 1A;
  • FIG. 2B shows the embodiment of an engagement catheter shown in FIG. 2A;
  • FIG. 2C shows another view of the distal end of the engagement catheter embodiment shown in FIGS. 2A and 2B;
  • FIG. 3A shows removal of an embodiment of a catheter as disclosed herein;
  • FIG. 3B shows the resealing of a puncture according to an embodiment as disclosed herein;
  • FIG. 4A to 4C show a closure of a hole in the atrial wall using an embodiment as disclosed herein;
  • FIG. 5A shows an embodiment of an engagement catheter as disclosed herein;
  • FIG. 5B shows a cross-sectional view of the proximal end of the engagement catheter shown in FIG. 5A;
  • FIG. 5C shows a cross-sectional view of the distal end of the engagement catheter shown in FIG. 5A;
  • FIG. 5D shows the engagement catheter shown in FIG. 5A approaching a heart wall from inside of the heart;
  • FIG. 6A shows an embodiment of a delivery catheter as disclosed herein;
  • FIG. 6B shows a close-up view of the needle shown in FIG. 6A;
  • FIG. 6C shows a cross-sectional view of the needle shown in FIGS. 6A and 6B.
  • DETAILED DESCRIPTION
  • It will be appreciated by those of skill in the art that the following detailed description of the disclosed embodiments is merely exemplary in nature and is not intended to limit the scope of the appended claims.
  • The disclosed embodiments include devices, systems, and methods useful for accessing various tissues of the heart from inside the heart. For example, various embodiments provide for percutaneous, intravascular access into the pericardial space through an atrial wall or the wall of an atrial appendage. In at least some embodiments, the heart wall is aspirated and retracted from the pericardial sac to increase the pericardial space between the heart and the sac and thereby facilitate access into the space.
  • Unlike the relatively stiff pericardial sac, the atrial wall and atrial appendage are rather soft and deformable. Hence, suction of the atrial wall or atrial appendage can provide significantly more clearance of the cardiac structure from the pericardium as compared to suction of the pericardium. Furthermore, navigation from the intravascular region (inside of the heart) provides more certainty of position of vital cardiac structures than does intrathoracic access (outside of the heart).
  • Access to the pericardial space may be used for identification of diagnostic markers in the pericardial fluid; for pericardiocentesis; and for administration of therapeutic factors with angiogenic, myogenic, and antiarrhythmic potential. In addition, epicardial pacing leads may be delivered via the pericardial space, and an ablation catheter may be used on the epicardial tissue from the pericardial space.
  • In the embodiment of the catheter system shown in FIG. 1A, catheter system 10 includes an engagement catheter 20, a delivery catheter 30, and a needle 40. Although each of engagement catheter 20, delivery catheter 30, and needle 40 has a proximal end and a distal end, FIG. 1A shows only the distal end. Engagement catheter 20 has a lumen through which delivery catheter 30 has been inserted, and delivery catheter 30 has a lumen through which needle 40 has been inserted. Delivery catheter 30 also has a number of openings 50 that can be used to transmit fluid from the lumen of the catheter to the heart tissue in close proximity to the distal end of the catheter.
  • As shown in more detail in FIGS. 2A, 2B, 2C, engagement catheter 20 includes a vacuum channel 60 used for suction of a targeted tissue 65 in the heart and an injection channel 70 used for infusion of substances to targeted tissue 65, including, for example, a biological or non-biological degradable adhesive. As is shown in FIGS. 2B and 2C, injection channel 70 is ring-shaped, which tends to provide relatively even dispersal of the infused substance over the targeted tissue, but other shapes of injection channels may be suitable. A syringe 80 is attached to injection channel 70 for delivery of the appropriate substances to injection channel 70, and a syringe 90 is attached to vacuum channel 60 through a vacuum port (not shown) at the proximal end of engagement catheter 20 to provide appropriate suction through vacuum channel 60. At the distal end of engagement catheter 20, a suction port 95 is attached to vacuum channel 60 for contacting targeted tissue 65, such that suction port 95 surrounds targeted tissue 65, which is thereby encompassed within the circumference of suction port 95. Although syringe 90 is shown in FIG. 2B as the vacuum source providing suction for engagement catheter 20, other types of vacuum sources may be used, such as a controlled vacuum system providing specific suction pressures. Similarly, syringe 80 serves as the external fluid source in the embodiment shown in FIG. 2B, but other external fluid sources may be used.
  • A route of entry for use of various embodiments disclosed herein is through the jugular or femoral vein to the superior or inferior vena cavae, respectively, to the right atrial wall or atrial appendage (percutaneously) to the pericardial sac (through puncture).
  • Referring now to FIG. 1B, an engagement catheter 100 is placed via standard approach into the jugular or femoral vein. The catheter, which may be 4 or 5 Fr., is positioned under fluoroscopic or echocardiographic guidance into the right atrial appendage 110. Suction is initiated to aspirate a portion of atrial appendage 110 away from the pericardial sac 120 that surrounds the heart. As explained herein, aspiration of the heart tissue is evidenced when no blood can be pulled back through engagement catheter 100 and, if suction pressure is being measured, when the suction pressure gradually increases. A delivery catheter 130 is then inserted through a lumen of engagement catheter 100. A small perforation can be made in the aspirated atrial appendage 110 with a needle such as needle 40, as shown in FIGS. 1A and 2A. A guide wire (not shown) can then be advanced through delivery catheter 130 into the pericardial space to secure the point of entry 125 through the atrial appendage and guide further insertion of delivery catheter 130 or another catheter. Flouroscopy or echocardiogram can be used to confirm the position of the catheter in the pericardial space. Alternatively, a pressure tip needle can sense the pressure and measure the pressure change from the atrium (about 10 mmHg) to the pericardial space (about 2 mmHg). This is particularly helpful for transeptal access where puncture of arterial structures (e.g., the aorta) can be diagnosed and sealed with an adhesive, as described in more detail below.
  • Although aspiration of the atrial wall or the atrial appendage retracts the wall or appendage from the pericardial sac to create additional pericardial space, CO2 gas can be delivered through a catheter, such as delivery catheter 130, into the pericardial space to create additional space between the pericardial sac and the heart surface.
  • Referring now to FIG. 3A, the catheter system shown in FIG. 1B is retrieved by pull back through the route of entry. However, the puncture of the targeted tissue in the heart (e.g., the right atrial appendage as shown in FIG. 3A) may be sealed upon withdrawal of the catheter, which prevents bleeding into the pericardial space. The retrieval of the catheter may be combined with a sealing of the tissue in one of several ways: (1) release of a tissue adhesive or polymer 75 via injection channel 70 to seal off the puncture hole, as shown in FIG. 3B; (2) release of an inner clip or mechanical stitch to close off the hole from the inside of the cavity; or (3) mechanical closure of the heart with a sandwich type mechanical device that approaches the hole from both sides of the wall (see FIGS. 4A, 4B, and 4C). In other words, closure may be accomplished by using, for example, a biodegradable adhesive material (e.g., fibrin glue or cyanomethacrylate), a magnetic system, or an umbrella-shaped nitinol stent. An example of the closure of a hole in the atrium is shown in FIG. 3B. Engagement catheter 20 is attached to targeted tissue 95 using suction through suction port 60. Tissue adhesive 75 is injected through injection channel 70 to coat and seal the puncture wound in targeted tissue 95. Engagement catheter 20 is then withdrawn, leaving a plug of tissue adhesive 75 attached to the atrial wall or atrial appendage.
  • Another example for sealing the puncture wound in the atrial wall or appendage is shown in FIGS. 4A, 4B, and 4C. A sandwich-type closure, having an external cover 610 and an internal cover 620, is inserted through the lumen of engagement catheter 600, which is attached to the targeted tissue of an atrial wall 630. Each of external and internal covers 610 and 620 is similar to an umbrella in that it can be inserted through a catheter in its folded configuration and expanded once it is outside of the catheter. As shown in FIG. 4A, external cover 610 is deployed (in its expanded configuration) on the outside of the atrial wall to seal a puncture wound in the targeted tissue. Internal cover 620 is delivered through engagement catheter 600 (in its folded configuration), as shown in FIGS. 4A and 4B. Once internal cover 620 is in position on the inside of atrial wall 630 at the targeted tissue, internal cover 620 is deployed to help seal the puncture wound in the targeted tissue (see FIG. 4C). Engagement catheter 600 then releases its grip on the targeted tissue and is withdrawn, leaving the sandwich-type closure to seal the puncture wound, as shown in FIG. 4C. External cover 610 and internal cover 620 may be held in place using adhesion or magnetic forces.
  • FIGS. 5A, 5B, 5C, and 5D show another embodiment of an engagement catheter as disclosed herein. Engagement catheter 700 is an elongated tube having a proximal end 710 and a distal end 720, as well as two lumens 730, 740 extending between proximal end 710 and distal end 720. Lumens 730, 740 are formed by concentric inner wall 750 and outer wall 760, as particularly shown in FIGS. 5B and 5C. At proximal end 710, engagement catheter 700 includes a vacuum port 770, which is attached to lumen 730 so that a vacuum source can be attached to vacuum port 770 to create suction in lumen 730, thereby forming a suction channel. At distal end 720 of catheter 700, a suction port 780 is attached to lumen 730 so that suction port 780 can be placed in contact with heart tissue 775 (see FIG. 5D) for aspirating the tissue, thereby forming a vacuum seal between suction port 780 and tissue 775 when the vacuum source is attached and engaged. The vacuum seal enables suction port 780 to grip, stabilize, and retract tissue 775. For example, attaching a suction port to an interior atrial wall using a vacuum source enables the suction port to retract the atrial wall from the pericardial sac surrounding the heart, which enlarges the pericardial space between the atrial wall and the pericardial sac.
  • As shown in FIG. 5C, two internal lumen supports 810, 820 are located within lumen 730 and are attached to inner wall 750 and outer wall 760 to provide support to the walls. These lumen supports divide lumen 730 into two suction channels. Although internal lumen supports 810, 820 extend from distal end 720 of catheter 700 along a substantial portion of the length of catheter 700, internal lumen supports 810, 820 may or may not span the entire length of catheter 700. Indeed, as shown in FIGS. 5A, 5B, and 5C, internal lumen supports 810, 820 do not extend to proximal end 710 to ensure that the suction from the external vacuum source is distributed relatively evenly around the circumference of catheter 700. Although the embodiment shown in FIG. 5C includes two internal lumen supports, other embodiments may have just one internal support or even three or more such supports.
  • FIG. 5D shows engagement catheter 700 approaching heart tissue 775 for attachment thereto. It is important for the clinician performing the procedure to know when the suction port has engaged the tissue of the atrial wall or the atrial appendage. For example, in reference to FIG. 5D, it is clear that suction port 780 has not fully engaged tissue 775 such that a seal is formed. However, because suction port 780 is not usually seen during the procedure, the clinician may determine when the proper vacuum seal between the atrial tissue and the suction port has been made by monitoring the amount of blood that is aspirated, by monitoring the suction pressure with a pressure sensor/regulator, or both. For example, as engagement catheter 700 approaches the atrial wall tissue (such as tissue 775) and is approximately in position, the suction can be activated through lumen 730. A certain level of suction (e.g., 10 mmHg) can be imposed and measured with a pressure sensor/regulator. As long as catheter 700 does not engage the wall, some blood will be aspirated into the catheter and the suction pressure will remain the same. However, when catheter 700 engages or attaches to the wall of the heart (depicted as tissue 775 in FIG. 5D), minimal blood is aspirated and the suction pressure will start to gradually increase. Each of these signs can alert the clinician (through alarm or other means) as an indication of engagement. The pressure regulator is then able to maintain the suction pressure at a preset value to prevent over-suction of the tissue.
  • An engagement catheter, such as engagement catheter 700, may be configured to deliver a fluid or other substance to tissue on the inside of a wall of the heart, including an atrial wall or a ventricle wall. For example, lumen 740 shown in FIGS. 5A and 5C includes an injection channel 790 at distal end 720. Injection channel 790 dispenses to the targeted tissue a substance flowing through lumen 740. As shown in FIG. 5D, injection channel 790 is the distal end of lumen 740. However, in other embodiments, the injection channel may be ring-shaped (see FIG. 2C) or have some other suitable configuration.
  • Substances that can be locally administered with an engagement catheter include preparations for gene or cell therapy, drugs, and adhesives that are safe for use in the heart. The proximal end of lumen 740 has a fluid port 800, which is capable of attachment to an external fluid source for supply of the fluid to be delivered to the targeted tissue. Indeed, after withdrawal of a needle from the targeted tissue, as discussed herein, an adhesive may be administered to the targeted tissue by the engagement catheter for sealing the puncture wound left by the needle withdrawn from the targeted tissue.
  • Referring now to FIGS. 6A, 6B, and 6C, there is shown a delivery catheter 850 comprising an elongated hollow tube 880 having a proximal end 860, a distal end 870, and a lumen 885 along the length of the catheter. Extending from distal end 870 is a hollow needle 890 in communication with lumen 885. Needle 890 is attached to distal end 870 in the embodiment of FIGS. 6A, 6B, and 6C, but, in other embodiments, the needle may be removably attached to, or otherwise located at, the distal end of the catheter (see FIG. 1A). In the embodiment shown in FIGS. 6A, 6B, and 6C, as in certain other embodiments having an attached needle, the junction (i.e., site of attachment) between hollow tube 880 and needle 890 forms a security notch 910 circumferentially around needle 890 to prevent needle 890 from over-perforation. Thus, when a clinician inserts needle 890 through an atrial wall to gain access to the pericardial space, the clinician will not, under normal conditions, unintentionally perforate the pericardial sac with needle 890 because the larger diameter of hollow tube 880 (as compared to that of needle 890) at security notch 910 hinders further needle insertion. Although security notch 910 is formed by the junction of hollow tube 880 and needle 890 in the embodiment shown in FIGS. 6A, 6B, and 6C, other embodiments may have a security notch that is configured differently. For example, a security notch may include a band, ring, or similar device that is attached to the needle a suitable distance from the tip of the needle. Like security notch 910, other security notch embodiments hinder insertion of the needle past the notch itself by presenting a larger profile than the profile of the needle such that the notch does not easily enter the hole in the tissue caused by entry of the needle.
  • It is useful for the clinician performing the procedure to know when the needle has punctured the atrial tissue. This can be done in several ways. For example, the delivery catheter can be connected to a pressure transducer to measure pressure at the tip of the needle. Because the pressure is lower and much less pulsatile in the pericardial space than in the atrium, the clinician can recognize immediately when the needle passes through the atrial tissue into the pericardial space.
  • Alternatively, as shown in FIG. 6B, needle 890 may be connected to a strain gauge 915 as part of the catheter assembly. When needle 890 contacts tissue (not shown), needle 890 will be deformed. The deformation will be transmitted to strain gauge 915 and an electrical signal will reflect the deformation (through a classical wheatstone bridge), thereby alerting the clinician. Such confirmation of the puncture of the wall can prevent over-puncture and can provide additional control of the procedure.
  • In some embodiments, a delivery catheter, such as catheter 850 shown in FIGS. 6A, 6B, and 6C, is used with an engagement catheter, such as catheter 700 shown in FIGS. 5A, 5B, 5C, and 5D, to gain access to the pericardial space between the heart wall and the pericardial sac. For example, engagement catheter 700 may be inserted into the vascular system and advanced such that the distal end of the engagement catheter is within the atrium. The engagement catheter may be attached to the targeted tissue on the interior of a wall of the atrium using a suction port as disclosed herein. A standard guide wire may be inserted through the lumen of the delivery catheter as the delivery catheter is inserted through the inner lumen of the engagement catheter, such as lumen 740 shown in FIGS. 5B and 5C. Use of the guide wire enables more effective navigation of the delivery catheter 850 and prevents the needle 890 from damaging the inner wall 750 of the engagement catheter 700. When the tip of the delivery catheter with the protruding guide wire reaches the atrium, the wire is pulled back, and the needle is pushed forward to perforate the targeted tissue. The guide wire is then advanced through the perforation into the pericardial space, providing access to the pericardial space through the atrial wall.
  • Referring again to FIGS. 6A, 6B, and 6C, lumen 885 of delivery catheter 850 may be used for delivering fluid into the pericardial space after needle 890 is inserted through the atrial wall or the atrial appendage. After puncture of the wall or appendage, a guide wire (not shown) may be inserted through needle lumen 900 into the pericardial space to maintain access through the atrial wall or appendage. Fluid may then be introduced to the pericardial space in a number of ways. For example, after the needle punctures the atrial wall or appendage, the needle is generally withdrawn. If the needle is permanently attached to the delivery catheter, as in the embodiment shown in FIGS. 6A and 6B, then delivery catheter 850 would be withdrawn and another delivery catheter (without an attached needle) would be introduced over the guide wire into the pericardial space. Fluid may then be introduced into the pericardial space through the lumen of the second delivery catheter.
  • In some embodiments, however, only a single delivery catheter is used. In such embodiments, the needle is not attached to the delivery catheter, but instead may be a needle wire (see FIG. 1A). In such embodiments, the needle is withdrawn through the lumen of the delivery catheter, and the delivery catheter may be inserted over the guide wire into the pericardial space. Fluid is then introduced into the pericardial space through the lumen of the delivery catheter.
  • The various embodiments disclosed herein may be used by clinicians, for example: (1) to deliver genes, cells, drugs, etc.; (2) to provide catheter access for epicardial stimulation; (3) to evacuate fluids acutely (e.g., in cases of pericardial tampondae) or chronically (e.g., to alleviate effusion caused by chronic renal disease, cancer, etc.); (4) to perform transeptal puncture and delivery of a catheter through the left atrial appendage for electrophysiological therapy, biopsy, etc.; (5) to deliver a magnetic glue or ring through the right atrial appendage to the aortic root to hold a percutaneous aortic valve in place; (6) to deliver a catheter for tissue ablation, e.g., to the pulmonary veins, or right atrial and epicardial surface of the heart for atrial and ventricular arrythmias; (7) to deliver and place epicardial, right atrial, and right and left ventricle pacing leads; (8) to occlude the left atrial appendage through percutaneous approach; and (9) to visualize the pericardial space with endo-camera or scope to navigate the epicardial surface of the heart for therapeutic delivery, diagnosis, lead placement, mapping, etc. Many other applications, not explicitly listed here, are also possible and within the scope of the present disclosure.
  • While various embodiments of devices, systems, and methods for accessing the heart tissue have been described in considerable detail herein, the embodiments are merely offered by way of non-limiting examples of the invention described herein. Many variations and modifications of the embodiments described herein will be apparent to one of ordinary skill in the art in light of the this disclosure. It will therefore be understood by those skilled in the art that various changes and modifications may be made, and equivalents may be substituted for elements thereof, without departing from the scope of the invention. Indeed, this disclosure is not intended to be exhaustive or to limit the scope of the invention. The scope of the invention is to be defined by the appended claims, and by their equivalents.
  • Further, in describing representative embodiments, the disclosure may have presented a method and/or process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. As one of ordinary skill in the art would appreciate, other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations on the claims. In addition, the claims directed to a method and/or process should not be limited to the performance of their steps in the order written, and one skilled in the art can readily appreciate that the sequences may be varied and still remain within the spirit and scope of the present invention.
  • It is therefore intended that the invention will include, and this description and the appended claims will encompass, all modifications and changes apparent to those of ordinary skill in the art based on this disclosure.

Claims (32)

1. A system for use with a vacuum source for accessing the tissue of a heart, comprising:
an engagement catheter comprising a proximal end, a distal end, and first and second lumens extending between the proximal end and the distal end;
a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured such that the hollow tube is capable of insertion into the second lumen of the engagement catheter;
a needle located at the distal end of the delivery catheter; and
a vacuum port located at the proximal end of the engagement catheter, the vacuum port being operatively connected to the first lumen of the engagement catheter and capable of operative connection to the vacuum source;
wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when the vacuum source is operatively attached to the vacuum port, and
wherein the system is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds the heart by retracting the targeted tissue away from the pericardial sac.
2. The system of claim 1, wherein the targeted tissue comprises a portion of an atrial wall.
3. The system of claim 1, wherein the targeted tissue comprises a portion of an atrial appendage.
4. The system of claim 1, wherein:
the needle is positioned to be capable of piercing the targeted tissue when the hollow tube is inserted into the second lumen and the suction port is attached to the targeted tissue, such that, when the targeted tissue is pierced, access to the pericardial space is achieved.
5. The system of claim 4, further comprising:
a guide wire for insertion into the pericardial space.
6. The system of claim 5, wherein:
the needle comprises a hollow needle in communication with the hollow tube, and
the guide wire is capable of insertion through the hollow tube and the hollow needle into the pericardial space.
7. The system of claim 1, wherein the engagement catheter further comprises an injection channel in fluid communication with the second lumen of the engagement catheter, the injection channel being configured to administer a fluid to the targeted tissue.
8. The system of claim 7, wherein the fluid comprises an adhesive.
9. The system of claim 7, wherein the injection channel is ring-shaped.
10. The system of claim 1, wherein the engagement catheter further comprises an injection channel formed along the length of the engagement catheter, the injection channel having at its distal end at least one opening for administering a fluid to the targeted tissue, the injection channel being capable of operable attachment to an external fluid source at the proximal end of the injection channel, such that fluid from the external fluid source can flow through the injection channel to the targeted tissue when the external fluid source is operatively attached to the injection channel.
11. The system of claim 1, wherein the needle comprises a needle wire for piercing the targeted tissue.
12. The system of claim 1, wherein the needle comprises a pressure tip needle.
13. An engagement catheter for use with a vacuum source in accessing heart tissue, comprising:
an elongated tube comprising a proximal end, a distal end, an outer wall positioned circumferentially along the length of the tube, and an inner wall positioned circumferentially along the length of the tube, wherein the outer wall and the inner wall form at least one suction channel along the length of the tube between the outer wall and the inner wall;
a vacuum port in communication with the proximal end of the tube, the vacuum port being operatively connected to the at least one suction channel and capable of operative connection to the vacuum source; and
a suction port in communication with the at least one suction channel at the distal end of the tube, the suction port configured to removably attach to targeted tissue on the interior of a wall of the heart such that the suction port is capable of forming a reversible seal with the wall of the heart when the vacuum source is operatively attached to the vacuum port,
wherein the engagement catheter is capable of enlarging a pericardial space between the heart and a pericardial sac when the suction port is attached to the interior wall of the heart.
14. The engagement catheter of claim 13, further comprising:
at least one internal lumen support positioned within the at least one suction channel and attached to the outer wall and the inner wall, the at least one internal lumen support extending from the distal end of the tube along at least a substantial portion of the length of the tube.
15. The engagement catheter of claim 14, wherein:
the at least one internal lumen support comprises two internal lumen supports and the at least one suction channel comprises two suction channels.
16. The engagement catheter of claim 13, further comprising:
an injection channel formed along the length of the tube, the injection channel having at its distal end at least one opening for administering a fluid to the targeted tissue, the injection channel being capable of operable attachment to an external fluid source at the proximal end of the injection channel, such that fluid from the external fluid source can flow through the injection channel to the targeted tissue when the external fluid source is operatively attached to the injection channel.
17. A delivery catheter for use in accessing a pericardial space surrounding the external surface of a heart, comprising
an elongated hollow tube comprising a proximal end, a distal end, and a lumen;
a needle extending from the distal end of the tube; and
a security notch formed circumferentially around the needle, the security notch being configured to prevent over-perforation of the needle when piercing a wall of the heart into the pericardial space.
18. The delivery catheter of claim 17, further comprising:
an elongated guide wire sized to be placed inside the lumen of the tube.
19. The delivery catheter of claim 18, wherein:
the needle comprises a hollow needle in communication with the lumen of the hollow tube, and
the distal end of the guide wire is capable of insertion through the hollow tube and the hollow needle to access the pericardial space.
20. The delivery catheter of claim 17, wherein the tube further comprises at least one opening at the distal end of the tube for administering a fluid to the external surface of the heart located in the pericardial space, such that the at least one opening is in fluid communication with the lumen of the tube.
21. A method of accessing the tissue of a heart, the method comprising the steps of: providing a system, comprising:
an engagement catheter comprising a proximal end, a distal end, and first and second lumens extending between the proximal end and the distal end;
a delivery catheter comprising a proximal end, a distal end, and a hollow tube extending between the proximal end and the distal end, the delivery catheter configured to be inserted into the second lumen of the engagement catheter;
a needle located at the distal end of the delivery catheter; and
a vacuum port located at the proximal end of the engagement catheter, the vacuum port being operatively connected to the first lumen of the engagement catheter and capable of operative connection to the vacuum source;
wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to removably attach to a targeted tissue on the interior of a wall of the heart, such that the suction port is capable of forming a reversible seal with the targeted tissue when the vacuum source is operatively attached to the vacuum port, and
wherein the system is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds the heart by retracting the targeted tissue away from the pericardial sac;
inserting the engagement catheter into the body such that the distal end of the engagement catheter is positioned inside the heart and the suction port is in contact with the targeted tissue on the interior of a wall of the heart;
operatively connecting a vacuum source to the vacuum port such that the suction port is reversibly attached to the targeted tissue on the interior of a wall of the heart;
inserting the delivery catheter into the second lumen of the engagement catheter;
piercing the targeted tissue on the interior of a wall of the heart with the needle; and
administering a substance into the pericardial space.
22. The method of claim 21, further comprising:
withdrawing the needle from the targeted tissue; and
administering a substance to the targeted tissue after withdrawal of the needle.
23. The method of claim 22, wherein:
the substance comprises an adhesive for sealing a puncture wound in the targeted tissue.
24. The method of claim 21, wherein:
the targeted tissue comprises a portion of an atrial wall.
25. The method of claim 21, wherein:
wherein the targeted tissue comprises a portion of an atrial appendage.
26. The method of claim 22, further comprising:
accessing the pericardial space by inserting a guide wire through the wall of the heart into the pericardial space.
27. A method of accessing the tissue of a heart, the method comprising:
extending into a blood vessel an elongated tube having a proximal end, a distal end, and at least one lumen, such that the distal end of the tube is in contact with a targeted tissue on the interior of a wall of the heart;
aspirating the targeted tissue such that the wall of the heart is retracted away from a pericardial sac surrounding the heart to enlarge a pericardial space between the pericardial sac and the wall of the heart;
delivering a fluid onto the targeted tissue; and
removing the elongated tube from the body.
28. The method of claim 27, further comprising:
inserting through one of the at least one lumen of the elongated tube a delivery catheter having a proximal end, a distal end, and a needle located at the distal end, such that the needle is located within the heart;
inserting the needle into the targeted tissue; and
injecting a fluid into the pericardial space such that the fluid contacts the exterior of the heart within the pericardial space.
29. The method of claim 28, wherein:
the needle comprises a security notch circumferentially around the needle.
30. The method of claim 28, further comprising:
inserting at least the distal end of an elongated guide wire through the needle into the pericardial space;
withdrawing the needle from the targeted tissue; and
inserting the delivery catheter into the pericardial space.
31. The method of claim 27, wherein the elongated tube further comprises at least one internal lumen support positioned within the at least one lumen, the at least one internal lumen support extending from the distal end of the elongated tube along at least a substantial portion of the length of the elongated tube.
32. The method of claim 31, wherein the at least one internal lumen support comprises two internal lumen supports.
US12/305,864 2006-06-30 2007-06-29 Percutaneous intravascular access to cardiac tissue Abandoned US20100069849A1 (en)

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US12/722,287 Abandoned US20100168791A1 (en) 2006-06-30 2010-03-11 Systems and methods for closing a hole in cardiac tissue
US12/722,913 Active US8128593B2 (en) 2006-06-30 2010-03-12 Removing fluid from a bodily tissue via a catheter with circumferential concave grooves
US12/723,278 Active 2028-01-25 US8303481B2 (en) 2006-06-30 2010-03-12 Devices and methods for assisting heart function
US12/816,655 Active 2027-10-20 US8894606B2 (en) 2006-06-30 2010-06-16 Devices, systems, and methods for accessing cardiac tissue
US13/323,174 Active 2027-08-29 US8876776B2 (en) 2006-06-30 2011-12-12 Engagement catheter systems and devices and methods of using the same
US13/539,574 Active US8777904B2 (en) 2006-06-30 2012-07-02 Systems and methods for engaging heart tissue
US14/332,064 Abandoned US20170080218A9 (en) 2006-06-30 2014-07-15 Engagement and delivery catheter systems
US14/552,708 Active 2028-06-03 US9907954B2 (en) 2006-06-30 2014-11-25 Devices and systems for accessing cardiac tissue
US15/913,446 Active 2029-03-05 US11191955B2 (en) 2006-06-30 2018-03-06 Devices and systems for accessing cardiac tissue
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US12/723,278 Active 2028-01-25 US8303481B2 (en) 2006-06-30 2010-03-12 Devices and methods for assisting heart function
US12/816,655 Active 2027-10-20 US8894606B2 (en) 2006-06-30 2010-06-16 Devices, systems, and methods for accessing cardiac tissue
US13/323,174 Active 2027-08-29 US8876776B2 (en) 2006-06-30 2011-12-12 Engagement catheter systems and devices and methods of using the same
US13/539,574 Active US8777904B2 (en) 2006-06-30 2012-07-02 Systems and methods for engaging heart tissue
US14/332,064 Abandoned US20170080218A9 (en) 2006-06-30 2014-07-15 Engagement and delivery catheter systems
US14/552,708 Active 2028-06-03 US9907954B2 (en) 2006-06-30 2014-11-25 Devices and systems for accessing cardiac tissue
US15/913,446 Active 2029-03-05 US11191955B2 (en) 2006-06-30 2018-03-06 Devices and systems for accessing cardiac tissue
US17/544,731 Pending US20220088377A1 (en) 2006-06-30 2021-12-07 Devices and systems for accessing cardiac tissue

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100114093A1 (en) * 2007-03-13 2010-05-06 University Of Virginia Patent Foundation Epicardial Ablation Catheter and Method of Use
US20100211064A1 (en) * 2007-03-22 2010-08-19 University Of Virginia Patent Foundation Electrode Catheter for Ablation Purposes and Related Method Thereof
US20100241185A1 (en) * 2007-11-09 2010-09-23 University Of Virginia Patent Foundation Steerable epicardial pacing catheter system placed via the subxiphoid process
WO2012048005A2 (en) * 2010-10-05 2012-04-12 Emory University Devices, systems, and methods for improving access to cardiac and vascular chambers
US9511219B1 (en) * 2014-03-24 2016-12-06 Subhajit Datta Dual vacuum device for medical fixture placement including for thoracoscopic left ventricular lead placement
US10220134B2 (en) 2010-04-23 2019-03-05 Mark D. Wieczorek Transseptal access device and method of use
US10307569B2 (en) 2010-04-23 2019-06-04 Mark D. Wieczorek Transseptal access device and method of use
US11083381B2 (en) 2009-09-11 2021-08-10 University Of Virginia Patent Foundation Systems and methods for determining pressure frequency changes in a subject
US11324918B2 (en) * 2014-01-14 2022-05-10 The Charles Stark Draper Laboratory, Inc. Seeping flow anti-clotting blood catheter

Families Citing this family (92)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5148598B2 (en) 2006-05-03 2013-02-20 ラプトール リッジ, エルエルシー Tissue closure system and method
US8366707B2 (en) 2007-01-23 2013-02-05 Cvdevices Llc Systems and methods for epicardial navigation
US10238311B2 (en) 2007-01-23 2019-03-26 Cvdevices, Llc Devices, systems, and methods to evaluate cardiovascular function
PL2574287T3 (en) 2007-03-30 2015-10-30 Sentreheart Inc Devices for closing the left atrial appendage
US9050064B2 (en) * 2007-04-27 2015-06-09 Cvdevices, Llc Systems for engaging a bodily tissue and methods of using the same
JP5612073B2 (en) 2009-04-01 2014-10-22 センターハート・インコーポレイテッドSentreHEART, Inc. Tissue ligation apparatus and its operation
US8475525B2 (en) 2010-01-22 2013-07-02 4Tech Inc. Tricuspid valve repair using tension
US8961596B2 (en) 2010-01-22 2015-02-24 4Tech Inc. Method and apparatus for tricuspid valve repair using tension
US9307980B2 (en) 2010-01-22 2016-04-12 4Tech Inc. Tricuspid valve repair using tension
US10058323B2 (en) 2010-01-22 2018-08-28 4 Tech Inc. Tricuspid valve repair using tension
US9545289B2 (en) 2010-02-26 2017-01-17 The Board Of Trustees Of The Leland Stanford Junior University Systems and methods for endoluminal valve creation
US8986278B2 (en) * 2010-04-13 2015-03-24 Sentreheart, Inc. Methods and devices for pericardial access
US11419632B2 (en) 2010-04-23 2022-08-23 Mark D. Wieczorek, P.C. Transseptal access device and method of use
AU2011299232A1 (en) 2010-09-07 2013-05-02 Paul A. Spence Cannula systems and methods
EP3777727B1 (en) 2011-04-20 2024-01-24 The Board of Trustees of the Leland Stanford Junior University Systems for endoluminal valve creation
EP2734157B1 (en) 2011-07-21 2018-09-05 4Tech Inc. Apparatus for tricuspid valve repair using tension
EP4101399A1 (en) 2011-08-05 2022-12-14 Route 92 Medical, Inc. System for treatment of acute ischemic stroke
US10314594B2 (en) 2012-12-14 2019-06-11 Corquest Medical, Inc. Assembly and method for left atrial appendage occlusion
US10307167B2 (en) 2012-12-14 2019-06-04 Corquest Medical, Inc. Assembly and method for left atrial appendage occlusion
US10813630B2 (en) 2011-08-09 2020-10-27 Corquest Medical, Inc. Closure system for atrial wall
JP6189847B2 (en) 2011-10-14 2017-08-30 アシスト・メディカル・システムズ,インコーポレイテッド Apparatus for measuring and processing anatomical structures
JP5984372B2 (en) * 2011-12-09 2016-09-06 オリンパス株式会社 Pericardial fluid volume control system
EP2811923B1 (en) 2012-02-07 2019-10-16 Intervene, Inc. System for endoluminal valve creation
US9549679B2 (en) 2012-05-14 2017-01-24 Acist Medical Systems, Inc. Multiple transducer delivery device and method
US9244196B2 (en) 2012-05-25 2016-01-26 Johnson & Johnson Vision Care, Inc. Polymers and nanogel materials and methods for making and using the same
US8961594B2 (en) 2012-05-31 2015-02-24 4Tech Inc. Heart valve repair system
EP2908880B1 (en) * 2012-10-16 2018-12-05 Paul A. Spence Devices for facilitating flow from the heart to a blood pump
US20140142689A1 (en) 2012-11-21 2014-05-22 Didier De Canniere Device and method of treating heart valve malfunction
US9788948B2 (en) 2013-01-09 2017-10-17 4 Tech Inc. Soft tissue anchors and implantation techniques
WO2014110460A1 (en) 2013-01-10 2014-07-17 Intervene, Inc. Systems and methods for endoluminal valve creation
US9131932B2 (en) * 2013-02-01 2015-09-15 St. Jude Medical Puerto Rico Llc Dual lumen carrier tube with retractable sleeve and methods
CN105208978B (en) 2013-03-14 2016-12-07 4科技有限公司 There is the support of tether interface
US9814816B2 (en) 2013-06-21 2017-11-14 Corvivo, Inc. Artificial ventricles
US9320841B2 (en) * 2013-06-21 2016-04-26 Corvivo, Inc. Ventricular assist device
WO2015048565A2 (en) 2013-09-27 2015-04-02 Intervene, Inc. Visualization devices, systems, and methods for informing intravascular procedures on blood vessel valves
US10022114B2 (en) 2013-10-30 2018-07-17 4Tech Inc. Percutaneous tether locking
US10052095B2 (en) 2013-10-30 2018-08-21 4Tech Inc. Multiple anchoring-point tension system
WO2015063580A2 (en) 2013-10-30 2015-05-07 4Tech Inc. Multiple anchoring-point tension system
US10485545B2 (en) 2013-11-19 2019-11-26 Datascope Corp. Fastener applicator with interlock
US9566443B2 (en) 2013-11-26 2017-02-14 Corquest Medical, Inc. System for treating heart valve malfunction including mitral regurgitation
US9265512B2 (en) 2013-12-23 2016-02-23 Silk Road Medical, Inc. Transcarotid neurovascular catheter
NZ722989A (en) 2014-01-10 2018-10-26 Bayer Healthcare Llc Single-use disposable set connector
EP3110478A4 (en) 2014-02-28 2017-10-11 Sentreheart, Inc. Pericardial access devices and methods
EP3122266B1 (en) 2014-03-24 2018-06-06 Intervene, Inc. Devices and systems for controlled hydrodissection of vessel walls
US9801720B2 (en) 2014-06-19 2017-10-31 4Tech Inc. Cardiac tissue cinching
CN107223062B (en) 2014-10-01 2019-12-17 心脏器械股份有限公司 Standby controller system with updates
JP6717820B2 (en) 2014-12-02 2020-07-08 4テック インコーポレイテッド Eccentric tissue anchor
JP5945586B2 (en) * 2014-12-08 2016-07-05 オリンパス株式会社 Medical device guide system
US10842626B2 (en) 2014-12-09 2020-11-24 Didier De Canniere Intracardiac device to correct mitral regurgitation
US10603018B2 (en) 2014-12-16 2020-03-31 Intervene, Inc. Intravascular devices, systems, and methods for the controlled dissection of body lumens
CA3207200A1 (en) 2015-01-09 2016-07-14 Bayer Healthcare Llc Multiple fluid delivery system with multi-use disposable set and features thereof
EP4241820A1 (en) * 2015-01-23 2023-09-13 Terumo Kabushiki Kaisha Guide wire
US10426497B2 (en) 2015-07-24 2019-10-01 Route 92 Medical, Inc. Anchoring delivery system and methods
US11065019B1 (en) 2015-02-04 2021-07-20 Route 92 Medical, Inc. Aspiration catheter systems and methods of use
DE202016009165U1 (en) 2015-02-04 2023-04-26 Route 92 Medical, Inc. Rapid Aspiration Thrombectomy System
JP6937700B2 (en) 2015-05-15 2021-09-22 ザ ユナイテッド ステイツ オブ アメリカ, アズ リプレゼンテッド バイ ザ セクレタリー, デパートメント オブ ヘルス アンド ヒューマン サービシーズ 3D right atrial appendage curved catheter
US10646247B2 (en) 2016-04-01 2020-05-12 Intervene, Inc. Intraluminal tissue modifying systems and associated devices and methods
WO2017218372A1 (en) 2016-06-15 2017-12-21 Bayer Healthcare Llc Multi-use disposable system and syringe therefor
CN106215261B (en) * 2016-08-29 2018-10-02 安徽通灵仿生科技有限公司 A kind of ventricle subsidiary conduit pump
CN110650673A (en) 2016-08-30 2020-01-03 加利福尼亚大学董事会 Methods for biomedical targeting and delivery and devices and systems for practicing the same
WO2018057963A1 (en) 2016-09-23 2018-03-29 Sentreheart, Inc. Devices and methods for left atrial appendage closure
US11266810B2 (en) 2016-10-10 2022-03-08 Clph, Llc Isolation and attachment catheters and methods for using them
CN110799236A (en) 2016-10-25 2020-02-14 玛芬股份有限公司 Vascular anchoring introducer sheath
WO2018132387A1 (en) 2017-01-10 2018-07-19 Route 92 Medical, Inc. Aspiration catheter systems and methods of use
WO2018136745A1 (en) 2017-01-20 2018-07-26 Route 92 Medical, Inc. Single operator intracranial medical device delivery systems and methods of use
WO2019018342A1 (en) 2017-07-17 2019-01-24 Voyager Therapeutics, Inc. Trajectory array guide system
EP3459469A1 (en) 2017-09-23 2019-03-27 Universität Zürich Medical occluder device
WO2019079788A1 (en) 2017-10-20 2019-04-25 Boston Scientific Scimed, Inc. Heart valve repair implant for treating tricuspid regurgitation
US11191547B2 (en) 2018-01-26 2021-12-07 Syntheon 2.0, LLC Left atrial appendage clipping device and methods for clipping the LAA
WO2019154847A1 (en) * 2018-02-06 2019-08-15 Septulus Ab Negative pressure-based gripping system and method
US20210030950A1 (en) * 2018-02-19 2021-02-04 Bayer Healthcare Llc Syringe rolling apparatus and method
EP3768160B1 (en) 2018-03-23 2023-06-07 Medtronic, Inc. Vfa cardiac therapy for tachycardia
US11400296B2 (en) 2018-03-23 2022-08-02 Medtronic, Inc. AV synchronous VfA cardiac therapy
JP2021518192A (en) 2018-03-23 2021-08-02 メドトロニック,インコーポレイテッド VfA cardiac resynchronization therapy
US11844526B2 (en) 2018-03-27 2023-12-19 Atricure, Inc. Devices and methods for left atrial appendage closure
WO2019191271A1 (en) 2018-03-28 2019-10-03 Datascope Corp. Device for atrial appendage exclusion
AU2019269606A1 (en) 2018-05-17 2020-12-03 Route 92 Medical, Inc. Aspiration catheter systems and methods of use
WO2020065582A1 (en) 2018-09-26 2020-04-02 Medtronic, Inc. Capture in ventricle-from-atrium cardiac therapy
US11679265B2 (en) 2019-02-14 2023-06-20 Medtronic, Inc. Lead-in-lead systems and methods for cardiac therapy
US11697025B2 (en) 2019-03-29 2023-07-11 Medtronic, Inc. Cardiac conduction system capture
US11213676B2 (en) * 2019-04-01 2022-01-04 Medtronic, Inc. Delivery systems for VfA cardiac therapy
US10925615B2 (en) 2019-05-03 2021-02-23 Syntheon 2.0, LLC Recapturable left atrial appendage clipping device and methods for recapturing a left atrial appendage clip
US11712188B2 (en) 2019-05-07 2023-08-01 Medtronic, Inc. Posterior left bundle branch engagement
US11305127B2 (en) 2019-08-26 2022-04-19 Medtronic Inc. VfA delivery and implant region detection
US20210138239A1 (en) 2019-09-25 2021-05-13 Swift Sync, Llc Transvenous Intracardiac Pacing Catheter
US11497431B2 (en) 2019-10-09 2022-11-15 Medtronic, Inc. Systems and methods for configuring cardiac therapy
US11642533B2 (en) 2019-11-04 2023-05-09 Medtronic, Inc. Systems and methods for evaluating cardiac therapy
US11813466B2 (en) 2020-01-27 2023-11-14 Medtronic, Inc. Atrioventricular nodal stimulation
CN115334978A (en) * 2020-03-20 2022-11-11 巴德外周血管股份有限公司 Sealant injection needle assembly and sealant delivery apparatus for pulmonary access procedures
US11813464B2 (en) 2020-07-31 2023-11-14 Medtronic, Inc. Cardiac conduction system evaluation
US11857417B2 (en) 2020-08-16 2024-01-02 Trilio Medical Ltd. Leaflet support
WO2022140784A1 (en) * 2020-12-22 2022-06-30 Nxt Biomedical, Llc Surgical drain methods and articles

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4946457A (en) * 1987-12-03 1990-08-07 Dimed, Incorporated Defibrillator system with cardiac leads and method for transvenous implantation
US4991578A (en) * 1989-04-04 1991-02-12 Siemens-Pacesetter, Inc. Method and system for implanting self-anchoring epicardial defibrillation electrodes
US5715817A (en) * 1993-06-29 1998-02-10 C.R. Bard, Inc. Bidirectional steering catheter
US5972013A (en) * 1997-09-19 1999-10-26 Comedicus Incorporated Direct pericardial access device with deflecting mechanism and method
US6200303B1 (en) * 1997-04-30 2001-03-13 Beth Israel Deaconess Medical Center, Inc. Method and kit for transvenously accessing the pericardial space via the right atrium
US6338345B1 (en) * 1999-04-07 2002-01-15 Endonetics, Inc. Submucosal prosthesis delivery device
US6613062B1 (en) * 1999-10-29 2003-09-02 Medtronic, Inc. Method and apparatus for providing intra-pericardial access
US6626930B1 (en) * 1999-10-21 2003-09-30 Edwards Lifesciences Corporation Minimally invasive mitral valve repair method and apparatus
US20040086479A1 (en) * 2001-02-26 2004-05-06 Duke University Novel dendritic polymers, crosslinked gels, and their biomedical uses
US6890295B2 (en) * 2002-10-31 2005-05-10 Medtronic, Inc. Anatomical space access tools and methods
US20060106442A1 (en) * 2004-05-19 2006-05-18 The Board Of Trustees Of The Leland Stanford Junior University Devices and methods for treating cardiac pathologies

Family Cites Families (75)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2922420A (en) * 1957-11-29 1960-01-26 Sierra Eng Co Epidural needle
US3583404A (en) * 1969-06-23 1971-06-08 Kendall & Co Nonblocking catheter
US3630207A (en) * 1969-08-08 1971-12-28 Cutter Lab Pericardial catheter
US4556059A (en) * 1982-09-03 1985-12-03 Adamson Jr Howard Spring operated tracheotome
CA1221596A (en) * 1984-03-09 1987-05-12 David Evans Surgical needle
US4552554A (en) * 1984-06-25 1985-11-12 Medi-Tech Incorporated Introducing catheter
US5041109A (en) * 1986-10-27 1991-08-20 University Of Florida Laser apparatus for the recanalization of vessels and the treatment of other cardiac conditions
US5195968A (en) * 1990-02-02 1993-03-23 Ingemar Lundquist Catheter steering mechanism
US5114401A (en) * 1990-02-23 1992-05-19 New England Deaconess Hospital Corporation Method for central venous catheterization
US5558644A (en) * 1991-07-16 1996-09-24 Heartport, Inc. Retrograde delivery catheter and method for inducing cardioplegic arrest
US5292332A (en) * 1992-07-27 1994-03-08 Lee Benjamin I Methods and device for percutanceous sealing of arterial puncture sites
US6572529B2 (en) * 1993-06-17 2003-06-03 Wilk Patent Development Corporation Intrapericardial assist method
ATE502664T1 (en) * 1993-07-19 2011-04-15 Angiotech Pharm Inc METHOD OF PRODUCTION OF A STENT WITH ANTI-ANGIOGENIC COMPOSITION
US5360416A (en) * 1993-09-30 1994-11-01 Sherwood Medical Company Thin-walled anesthesia needles
US5827216A (en) * 1995-06-07 1998-10-27 Cormedics Corp. Method and apparatus for accessing the pericardial space
US6398776B1 (en) * 1996-06-03 2002-06-04 Terumo Kabushiki Kaisha Tubular medical device
US6447539B1 (en) * 1996-09-16 2002-09-10 Transvascular, Inc. Method and apparatus for treating ischemic heart disease by providing transvenous myocardial perfusion
US6042581A (en) * 1996-11-08 2000-03-28 Thomas J. Fogarty Transvascular TMR device and method
US6733515B1 (en) * 1997-03-12 2004-05-11 Neomend, Inc. Universal introducer
US5968010A (en) * 1997-04-30 1999-10-19 Beth Israel Deaconess Medical Center, Inc. Method for transvenously accessing the pericardial space via the right atrium
US6123699A (en) * 1997-09-05 2000-09-26 Cordis Webster, Inc. Omni-directional steerable catheter
US6592552B1 (en) * 1997-09-19 2003-07-15 Cecil C. Schmidt Direct pericardial access device and method
US6340356B1 (en) * 1997-09-23 2002-01-22 NAVIA JOSé ANTONIO Intraluminal catheter with expandable tubular open-walled element
US6749617B1 (en) * 1997-11-04 2004-06-15 Scimed Life Systems, Inc. Catheter and implants for the delivery of therapeutic agents to tissues
US6113611A (en) * 1998-05-28 2000-09-05 Advanced Vascular Technologies, Llc Surgical fastener and delivery system
US6511412B1 (en) 1998-09-30 2003-01-28 L. Vad Technology, Inc. Cardivascular support control system
US6544215B1 (en) * 1998-10-02 2003-04-08 Scimed Life Systems, Inc. Steerable device for introducing diagnostic and therapeutic apparatus into the body
US6432039B1 (en) 1998-12-21 2002-08-13 Corset, Inc. Methods and apparatus for reinforcement of the heart ventricles
US6333345B1 (en) * 1999-05-14 2001-12-25 Sepracor, Inc. Methods of using and compositions comprising N-desmethylzolpidem
CA2376368C (en) * 1999-06-08 2009-08-11 Altea Technologies, Inc. Apparatus for microporation of biological membranes using thin film tissue interface devices, and method therefor
US6241706B1 (en) 1999-07-16 2001-06-05 Datascope Investment Corporation Fast response intra-aortic balloon pump
US7526342B2 (en) * 1999-08-10 2009-04-28 Maquet Cardiovascular Llc Apparatus for endoscopic cardiac mapping and lead placement
US20030187461A1 (en) * 1999-08-10 2003-10-02 Chin Albert K. Releasable guide and method for endoscopic cardiac lead placement
US7060200B1 (en) 1999-09-03 2006-06-13 Merck Patent Gmbh Multireactive polymerizable mesogenic compounds
US7842068B2 (en) * 2000-12-07 2010-11-30 Integrated Vascular Systems, Inc. Apparatus and methods for providing tactile feedback while delivering a closure device
GB2359024A (en) * 2000-02-09 2001-08-15 Anson Medical Ltd Fixator for arteries
US6589269B2 (en) * 2000-02-24 2003-07-08 Loma Linda University Medical Center Patch and glue delivery system for closing tissue openings during surgery
US7373197B2 (en) * 2000-03-03 2008-05-13 Intramedical Imaging, Llc Methods and devices to expand applications of intraoperative radiation probes
JP4674975B2 (en) * 2000-05-26 2011-04-20 オリンパス株式会社 Endoscope hood
WO2002017771A2 (en) * 2000-09-01 2002-03-07 Advanced Vascular Technologies, Llc Multi-fastener surgical apparatus and method
US6663633B1 (en) * 2000-10-25 2003-12-16 Pierson, Iii Raymond H. Helical orthopedic fixation and reduction device, insertion system, and associated methods
US20040018228A1 (en) * 2000-11-06 2004-01-29 Afmedica, Inc. Compositions and methods for reducing scar tissue formation
US6692458B2 (en) * 2000-12-19 2004-02-17 Edwards Lifesciences Corporation Intra-pericardial drug delivery device with multiple balloons and method for angiogenesis
US7740623B2 (en) 2001-01-13 2010-06-22 Medtronic, Inc. Devices and methods for interstitial injection of biologic agents into tissue
US6837848B2 (en) * 2003-01-15 2005-01-04 Medtronic, Inc. Methods and apparatus for accessing and stabilizing an area of the heart
US20030009145A1 (en) * 2001-03-23 2003-01-09 Struijker-Boudier Harry A.J. Delivery of drugs from sustained release devices implanted in myocardial tissue or in the pericardial space
US20020173803A1 (en) * 2001-05-01 2002-11-21 Stephen Ainsworth Self-closing surgical clip for tissue
US6626821B1 (en) * 2001-05-22 2003-09-30 Abiomed, Inc. Flow-balanced cardiac wrap
US20060052821A1 (en) * 2001-09-06 2006-03-09 Ovalis, Inc. Systems and methods for treating septal defects
US6776784B2 (en) * 2001-09-06 2004-08-17 Core Medical, Inc. Clip apparatus for closing septal defects and methods of use
US6755812B2 (en) * 2001-12-11 2004-06-29 Cardiac Pacemakers, Inc. Deflectable telescoping guide catheter
US6907298B2 (en) 2002-01-09 2005-06-14 Medtronic, Inc. Method and apparatus for imparting curves in implantable elongated medical instruments
US20030225420A1 (en) * 2002-03-11 2003-12-04 Wardle John L. Surgical coils and methods of deploying
JP2005522162A (en) 2002-03-18 2005-07-21 エスアールアイ インターナショナル Electroactive polymer devices that move fluids
US7029468B2 (en) * 2002-06-25 2006-04-18 Enpath Medical, Inc. Catheter assembly with side wall exit lumen and method therefor
US7903742B2 (en) * 2002-07-15 2011-03-08 Thomson Licensing Adaptive weighting of reference pictures in video decoding
US7681572B2 (en) 2002-08-20 2010-03-23 Aga Ab Method and devices for administration of therapeutic gases
US20050054994A1 (en) 2002-09-25 2005-03-10 Iulian Cioanta Catheters with suction capability and related methods and systems for obtaining biosamples in vivo
US20050261673A1 (en) * 2003-01-15 2005-11-24 Medtronic, Inc. Methods and apparatus for accessing and stabilizing an area of the heart
EP1599232B1 (en) * 2003-02-21 2013-08-14 Electro-Cat, LLC System for measuring cross-sectional areas and pressure gradients in luminal organs
US7165552B2 (en) * 2003-03-27 2007-01-23 Cierra, Inc. Methods and apparatus for treatment of patent foramen ovale
US7942897B2 (en) * 2003-07-10 2011-05-17 Boston Scientific Scimed, Inc. System for closing an opening in a body cavity
US7273446B2 (en) * 2003-10-31 2007-09-25 Spence Paul A Methods, devices and systems for counterpulsation of blood flow to and from the circulatory system
FR2862521B1 (en) * 2003-11-24 2006-09-22 Juan Carlos Chachques DIAGNOSTIC AND INJECTION CATHETER, IN PARTICULAR FOR HEART RING CARDIOLOGICAL APPLICATION
US7186214B2 (en) * 2004-02-12 2007-03-06 Medtronic, Inc. Instruments and methods for accessing an anatomic space
US7517321B2 (en) * 2005-01-31 2009-04-14 C. R. Bard, Inc. Quick cycle biopsy system
US7992567B2 (en) * 2005-02-08 2011-08-09 Koninklijke Philips Electronics N.V. System and method for percutaneous glossoplasty
US20070010793A1 (en) 2005-06-23 2007-01-11 Cardiac Pacemakers, Inc. Method and system for accessing a pericardial space
US8211084B2 (en) * 2006-06-30 2012-07-03 Cvdevices, Llc Devices, systems, and methods for accessing the epicardial surface of the heart
US8019404B2 (en) 2006-10-06 2011-09-13 The Cleveland Clinic Foundation Apparatus and method for targeting a body tissue
US20080269876A1 (en) * 2007-04-24 2008-10-30 Medtronic Vascular, Inc. Repair of Incompetent Heart Valves by Papillary Muscle Bulking
JP5174891B2 (en) * 2007-04-27 2013-04-03 シーヴィ デヴァイシズ,エルエルシー Devices, systems, and methods for accessing the epicardial surface of the heart
CA2739326A1 (en) 2008-10-10 2010-04-15 Intervalve, Inc. Valvuloplasty catheter and methods
US8628552B2 (en) * 2011-03-16 2014-01-14 Pacesetter, Inc. Apparatus and method for accessing an intrapericardial space
US9339295B2 (en) * 2012-10-22 2016-05-17 Sentreheart, Inc. Pericardial access devices and methods

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4946457A (en) * 1987-12-03 1990-08-07 Dimed, Incorporated Defibrillator system with cardiac leads and method for transvenous implantation
US4991578A (en) * 1989-04-04 1991-02-12 Siemens-Pacesetter, Inc. Method and system for implanting self-anchoring epicardial defibrillation electrodes
US5715817A (en) * 1993-06-29 1998-02-10 C.R. Bard, Inc. Bidirectional steering catheter
US6200303B1 (en) * 1997-04-30 2001-03-13 Beth Israel Deaconess Medical Center, Inc. Method and kit for transvenously accessing the pericardial space via the right atrium
US5972013A (en) * 1997-09-19 1999-10-26 Comedicus Incorporated Direct pericardial access device with deflecting mechanism and method
US6338345B1 (en) * 1999-04-07 2002-01-15 Endonetics, Inc. Submucosal prosthesis delivery device
US6626930B1 (en) * 1999-10-21 2003-09-30 Edwards Lifesciences Corporation Minimally invasive mitral valve repair method and apparatus
US6613062B1 (en) * 1999-10-29 2003-09-02 Medtronic, Inc. Method and apparatus for providing intra-pericardial access
US20040086479A1 (en) * 2001-02-26 2004-05-06 Duke University Novel dendritic polymers, crosslinked gels, and their biomedical uses
US6890295B2 (en) * 2002-10-31 2005-05-10 Medtronic, Inc. Anatomical space access tools and methods
US20060106442A1 (en) * 2004-05-19 2006-05-18 The Board Of Trustees Of The Leland Stanford Junior University Devices and methods for treating cardiac pathologies

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100114093A1 (en) * 2007-03-13 2010-05-06 University Of Virginia Patent Foundation Epicardial Ablation Catheter and Method of Use
US10702335B2 (en) 2007-03-13 2020-07-07 University Of Virginia Patent Foundation Electrode catheter for ablation purposes and related method thereof
US10166066B2 (en) 2007-03-13 2019-01-01 University Of Virginia Patent Foundation Epicardial ablation catheter and method of use
US20100211064A1 (en) * 2007-03-22 2010-08-19 University Of Virginia Patent Foundation Electrode Catheter for Ablation Purposes and Related Method Thereof
US9211405B2 (en) 2007-03-22 2015-12-15 University Of Virginia Patent Foundation Electrode catheter for ablation purposes and related method thereof
US20100241185A1 (en) * 2007-11-09 2010-09-23 University Of Virginia Patent Foundation Steerable epicardial pacing catheter system placed via the subxiphoid process
US11083381B2 (en) 2009-09-11 2021-08-10 University Of Virginia Patent Foundation Systems and methods for determining pressure frequency changes in a subject
US10307569B2 (en) 2010-04-23 2019-06-04 Mark D. Wieczorek Transseptal access device and method of use
US10220134B2 (en) 2010-04-23 2019-03-05 Mark D. Wieczorek Transseptal access device and method of use
WO2012048005A2 (en) * 2010-10-05 2012-04-12 Emory University Devices, systems, and methods for improving access to cardiac and vascular chambers
US10849652B2 (en) 2010-10-05 2020-12-01 Emory University Devices, systems, and methods for improving access to cardiac and vascular chambers
WO2012048005A3 (en) * 2010-10-05 2012-07-12 Emory University Devices, systems, and methods for improving access to cardiac and vascular chambers
US11324918B2 (en) * 2014-01-14 2022-05-10 The Charles Stark Draper Laboratory, Inc. Seeping flow anti-clotting blood catheter
US9511219B1 (en) * 2014-03-24 2016-12-06 Subhajit Datta Dual vacuum device for medical fixture placement including for thoracoscopic left ventricular lead placement

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