WO1982001644A1 - Anastomotic fitting - Google Patents

Anastomotic fitting Download PDF

Info

Publication number
WO1982001644A1
WO1982001644A1 PCT/US1981/001468 US8101468W WO8201644A1 WO 1982001644 A1 WO1982001644 A1 WO 1982001644A1 US 8101468 W US8101468 W US 8101468W WO 8201644 A1 WO8201644 A1 WO 8201644A1
Authority
WO
WIPO (PCT)
Prior art keywords
spikes
ringflange
anastomotic fitting
tube
graft
Prior art date
Application number
PCT/US1981/001468
Other languages
French (fr)
Inventor
Robert L Kaster
Original Assignee
Robert L Kaster
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Robert L Kaster filed Critical Robert L Kaster
Priority to AU78910/81A priority Critical patent/AU7891081A/en
Publication of WO1982001644A1 publication Critical patent/WO1982001644A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/064Blood vessels with special features to facilitate anastomotic coupling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1135End-to-side connections, e.g. T- or Y-connections

Definitions

  • the present invention pertains to a surgical prosthesis, and, more particularly, pertains to an anastomotic fitting for connecting a vascular graft to the wall of the ascending aorta.
  • Cardiovascular disease Diseases affecting the cardiovascular system are either congenital or acquired.
  • An acquired cardiovascular disease can result from living habits, infections or injuries during embryonic life, or at any time following birth.
  • Some diseases primarily affect the blood vessels; others only the heart itself.
  • Atherosclerosis is the major disease that affects the blood vessels. This disease may have its beginnings early in life and is first noted as a thickening of the arterial walls. This thickening is an accumulation of fat, fibrin, cellular debris and calcium. The resultant narrowing of the internal lumen of the vessel is called stenosis. Vessel stenosis impedes and reduces blood flow. Hypertension and dysfunction of the organ or area of the body that suffered the impaired blood flow can result.
  • aneurysm As the buildup on the interior wall of a vessel thickens, the vessel wall loses the ability to expand and contract. Also, the vessel loses its viability and becomes weakened and susceptible to bulging, also known as aneurysm. In the presence of hypertension or elevated blood pressure, aneurysms will frequently dissect and ultimately rupture.
  • Small vessels such as the arteries that supply blood to the heart, legs, intestines and other areas of the body, are particularly susceptible to atherosclerotic narrowing.
  • the loss of blood supply to the leg or segment of the intestine may result in gangrene.
  • Atherosclerotic narrowing of the coronary arteries impedes, limits and in some instances prevents blood flow to regional areas of the heart. Depending upon its severity and location within the coronary circulation, pain, cardiac dysfunction or death may result.
  • Atherosclerosis vascular complications produced by atherosclerosis, such as, stenosis, aneurysm, rupture and occlusion are, in the majority of cases, managed either medically or surgically. Control and elimination of hypertension is the more effective form of medical management. In cases in which atherosclerotic disease is advanced and the attendant complications jeopardize the health of the patient, surgical intervention is usually instituted.
  • Aneurysms and stenosis of major arteries are best corrected by a plastic reconstruction that does not require any synthetic graft or patch materials.
  • a plastic reconstruction that does not require any synthetic graft or patch materials.
  • the involved vessel section is transected and removed and a synthetic patch, conduit or graft is sewn into place.
  • a non-critical artery or vein of small diameter is harvested from elsewhere in the body and sewn into place in a manner that reestablishes flow to the area of the heart that earlier lost its blood supply because of atherosclerotic blockage and is referred to as an autograft.
  • an allograft or xenograft vessel may be employed.
  • experience with these latter two graft types is limited because of unsatisfactory results.
  • a synthetic graft is an alternative to an allograft or a xenograft. But, like the allograft and xenograft, the synthetic counterpart does not produce acceptable results.
  • the autograft because It is harvested from the patient, who in all probability is being operated on for atherosclerotic artery disease, is highly susceptible to atherosclerosis following surgery. Most harvested veins used in coronary artery bypass surgery exhibit some degree of atherosclerosis.
  • the long vein in the leg called the saphenous vein is the most commonly harvested vein for use as a vein bypass graft, in coronary artery surgery.
  • Most saphenous vein bypass grafts in time, exhibit a narrowing of the lumen unlike that of atherosclerosis. It is believed this is a pathologic response of the vein because it is of different cellular construction and composition than an artery—a condition for which it is not best suited.
  • Harvesting a saphenous vein autograft is a tedious surgical task and not always rewarded with the best quality graft.
  • removal of the saphenous vein disrupts the natural venous blood return from the leg and is not therapeutically recommended except for medical reasons such as in a patient with advanced venous disease such as varicose veins.
  • harvesting an autograft in the operating room requires additional surgical time and expense.
  • the coronary artery circulation begins with the right and left coronary arteries. These two arteries in turn give rise to an extensive coronary circulation.
  • atherosclerosis affects the larger coronary arteries. Therefore, a patient being operated upon for coronary artery disease will receive two or more vein grafts of various length and diameter depending upon the location of the blockage and the usable harvested saphenous vein.
  • coronary artery bypass surgery is widely practiced and has become a routine procedure in hospitals throughout the world, it is not without certain operative limitations that would best be avoided. Sewing the graft to host vessel, known as an anastomosis, requires delicate surgical techniques to accomplish the best possible result. There are several complications to be avoided when anastomosing a vessel and graft together.
  • junction between the host tissue and graft be a uniform transition without narrowing and regional irregularities such as protuberances that bulge into the lumen or sinuses that extend outward of the lumen.
  • a narrowing at the site of anastomosis reduces blood flow.
  • Protuberances into the lumen obstruct blood flow and may produce turbulence.
  • blood that stagnates in a sinus or cavity tends to clot and obstruct the vessel lumen and subsequently the blood flow. All these characteristics diminish the effectiveness and patency of the graft.
  • the limitations associated with the autograft as applied in coronary artery bypass surgery are: tedious surgical task to harvest, physically imperfect and irregular lumen, tedious surgical task to anastomose to host vessel, physically imperfect anastomosis of irregular and unsmooth transition between graft and vessel, functional narrowing of vein graft lumen during early postoperative period, and occlusion of the autograft due to thrombosis and/or continuance of the preexisting atherosclerotic process.
  • the anastomotic fitting of the present invention provides a device simplifying the surgical task of implanting coronary artery bypass grafts and of connecting two vessels to each other.
  • the anastomotic fitting provides a connection between the ascending aorta and a graft with smooth wall contours that are not obstructive to the natural flow of the blood.
  • the general purpose of the present invention is an anastomotic fitting for connecting a vascular graft to the ascending aorta, and providing for a uniform ostium having a smooth surface throughout from the aortic wall to the graft.
  • the anastomotic fitting accepts either a saphenous vein graft or a synthetic vascular graft, and is utilized in connecting a vascular graft of a first diameter to a blood vessel of a second diameter. While the blood vessel of a first diameter is usually of a lesser diameter than a blood vessel of a second diameter, the vessels can be of equal diameters or, in the alternative, the first diameter can be greater than a second lesser diameter.
  • the anastomotic fitting includes a cylindrical tube through which the vascular graft engages and overlaps at an inflow end where a ringflange spatially engages the overlapped end with the inflow end of the tube.
  • the anastomotic fitting engages in position in a hole in the aortic wall by the ringflange engaging against the inside aortic wall about the hole and by the fixation ring including a plurality of outward extending spikes engaging against the outside aortic wall about the hole.
  • an anastomotic fitting for connection between an aortic wall and a vascular graft
  • a cylindrical tube having a lumen extending therethrough, a ringflange circumferential indentation adjacent an inflow end of the tube and a plurality of locking ring grooves adjacent an outflow end of the tube
  • a ringflange having a circular member with a concentric central aperture larger than the outer diameter of the tube therethrough, and a triangular right-angle cross-section where the base is substantially parallel to the aortic wall, the hypotenuse engages against the inside aortic wall surface and the base includes a plurality of inwardly extending short and long spikes, the short spikes engaging the vascular graft at a plurality of points and the long spikes engaging through the vascular graft into the ringflange indentation; a fixation ring having a circular member with a central aperture therethrough and a truncated cone cross-section and pluralit
  • an anastomotic fitting including a combined fixation-locking ring whereby the fixation ring and locking ring of the previous embodiment described above are incorporated into a single integral unit thereby providing a three-component anastomotic fitting.
  • an anastomotic fitting including a tube with a flared end, a ringflange which engages a vascular graft between short spikes of the ringflange and the flared end and long spikes of the ringflange and a circumferential ringflange indentation in the tube, a fixation ring, and a locking ring thereby providing a four-component anastomotic fitting structurally similar to that of the anastomotic fitting previously described.
  • Vascular graft is encompassing in definition including biologic grafts being either human or animal and synthetic grafts, and is not to be construed as limited to a saphenous vein graft which is discussed by way of example and for purpos.s of illustration only.
  • Synthetic grafts can include woven materials of synthetic plastics, processed biologic materials, or composite metals.
  • One significant aspect and feature of the present invention is a precision ostium providing for facilitated surgical implantation, and safety and efficacy in vivo.
  • the precision nature of the ringflange with engagement of the inflow orifice of the tube provides a high-quality and consistent ostium.
  • the ringflange lies flat against the inside of the aortic wall and the peripheral edges are rounded, thereby reducing turbulence and aortic flow velocity.
  • the resultant ostium exhibits surface contours of least variation from the aortic wall to the vascular graft.
  • On account of the minimal surface projection of the ringflange there results a full orifice ostium and a nonrestr ⁇ ctive direct flow path from the aorta.
  • Coronary hemodynamics are superior to that of conventional hand-stitched anastomosis.
  • the anastomotic fitting includes geometrical components that engage in a predetermined relationship forming an integral unit, and that are subject to no movement following surgical implant. The 90° angle of exit from the aorta ensures maximum protection against thrombosis. In the event the aorta is thickened and/or calcified from extensive atherosclerotic disease, the anastomotic fitting provides for safe and effective attachment of a vascular graft.
  • Another significant aspect and feature of the present invention is an anastomotic fitting that provides for least surgical implant time and motion, that minimizes the influence of tissue and operative variables.
  • a further significant aspect and feature of the present invention is an anastomotic fitting which can be installed in less time, with greatest efficiency, and the utilization of fewest consumable supplies, equipment and expense.
  • the assembled component anastomotic fitting assures a tight, patent anastomotic fitting that enables both the aortic wall tissue around the hole and the saphenous vein if utilized to receive nutrients from the blood and remain viable.
  • the fitting can readily and easily be removed in least time without damage to surrounding tissue of the aortic wall about the hole.
  • the anastomotic fitting is adjustable to the friability of the aortic wall.
  • An object of the present invention is an entire blood flow path which is constructed of natural material.
  • the entire blood flow path from the ostium that confronts the aortic lumen and onward over the entire length of the bypass graft is the natural blood compatible surface of the lumen of the saphenous vein. Inverting the saphenous vein graft over the end of the tube produces a superior anastomotic ostium.
  • the ringflange is the only minimal foreign surface exposed to the blood and presents no adverse effect or influence on the long-term patency of the ostium or graft, especially when constructed of the highly blood-compatible material Pyrolite.
  • Another object of the present invention is an anastomotic fitting providing an unimpeded blood flow path of smooth transitional flow contours that reduces the effects of turbulence.
  • the ringflange that engages against the internal aortic wall provides minimal blood flow obstruction, turbulence and stagnation.
  • the anastomotic fitting also provides an external configuration that conforms with adjacent vessels and the limited available space in the chest cavity in the region of the heart.
  • Another object of the present invention is an anastomotic fitting including a ringflange that accepts vascular grafts including saphenous vein grafts of widely varying thickness.
  • the ringflange effectively engages saphenous vein grafts of a wide range of thicknesses and retains the grafts in frictionally engaged surface contact with the inflow end of the tube providing for unrestricted, natural circulation throughout the engaged tissues. Also the ringflange and fixation collar accept varying thicknesses of the aortic wall. The full orifice ostium is not narrowed and is not obstructive to blood flow from the aorta into the graft.
  • An additional object of the present invention is a patent lumen providing support for the full orifice anastomotic ostium where the tube also provides shielding protection for the first several millimeters of the graft. This prevents external forces such as intrathoracic pressures, blood flow pulsations and twisting of the graft from impinging on the anastomosis or first few millimeters of the graft. This reduces the potential narrowing of the ostium and occlusion of the lumen.
  • a further object of the present invention is an anastomotic fitting that engages the hole surrounding the aortic wall and that of the saphenous vein OF other biologic tissue vascular graft resulting in uninterrupted vascular circulation and blood supply to the tissues. The tissues therefore remain viable and the efficacy of the anastomosis is preserved.
  • FIG. 1' illustrates an exploded view of an anastomotic fitting including a tube, a ringflange, a fixation ring, and a locking ring where the tube is engaged through a hole in the aortic wall and a saphenous vein is engaged therebetween;
  • FIG. 2 illustrates a sectional view taken along line 2-2 of FIG.1;
  • FIG. 3 illustrates a sectional view taken along line 3-3 of FIG.1;
  • FIG. 4 illustrates a sectional view taken along line 4-4 of FIG.1;
  • FIG. 5 illustrates two anastomotic fittings positioned in the aortic wall;
  • FIG. 6 illustrates a sectional view taken along line 6-6 of FIG.
  • FIG. 7 illustrates a sectional view of an alternative embodiment of a three-component anastomotic fitting
  • FIG. 8 illustrates a sectional view taken along line 8-8 of FIG.
  • FIG. 9 illustrates a sectional view of an alternative embodiment of an anastomotic fitting.
  • FIG. 9A illustrates a sectional view taken along line 9A-9A of
  • FIG. 1 which illustrates an exploded view of the components of an anastomotic fitting 10 of the present invention, shows an anastomotic fitting 10 including tube 12, ringflange 14, a fixatibn ring 16 and a locking ring 18, about a saphenous vein 20 and engaged in a hole 22a in an aortic wall 22 having a hole 22a where all elements are now described in detail.
  • the tube which is a short hollow right cylinder 12a having an internal surface which is smooth and both ends 12b and 12c which are rounded having a radius of curvature equal to one-half of the wall thickness.
  • Concentric grooves are disposed on an external surface as now described.
  • a ringflange indentation 12e is positioned substantially within 2 millimeters (mm) of the inflow end 12d of the tube.
  • the bottom of the groove 12c is rounded and the sides of the groove are angled approximately 30 degrees to the plane normal to the central axis of the tube 12.
  • Locking ring grooves 12e including a plurality of identical grooves in the range of the five to ten extend about half of the external surface of the tube from the mid-region to the outflow end 12f and have a geometrical saw-tooth configuration.
  • One side of each groove is substantiall y normal, 85 degrees to 95 degrees, to the central axis of the tube 12.
  • the other side of each of these grooves is inclined at an angle of 15 degrees to the central axis or in the range of 10°-20° .
  • a representative tube 12 substantially measures 8.0 mm in length, 5.0 mm across its outside diameter, 3.5 mm across its inside diameter and 0.75 mm of wall thickness. Because grafts with varying dimensions are used as coronary artery bypass grafts, several sizes of anastomotic fittings including the tube 12 are required. Therefore, the range of dimensions of the tube 12 substantially encompass the following: 5.0 mm to 10.0 mm in length, 4.0 mm to 7.0 mm across the outside diameter, 2.5 mm to 5.5 mm across the inside diameter, and 0.6 mm to 1.5 mm of wall thickness.
  • FIG. 2 which illustrates a sectional view taken along line 2-2 of FIG. 1, shows the ringflange 14 including a circular member 14a with a concentric central aperture 14b.
  • the surfaces of the ringflange 14 are best disclosed by viewing the cross-sectional view seen of FIG. 1 in light of FIG. 2.
  • the cross-sectional geometry is that of a right triangle with the side of the triangle being equal to or longer than the base. In respect to the three sides of a triangle, the side is known as the blood surface 14c, the base is referred to as the graft surface 14d and the hypotenuse as the aortic wall surface 14e. Except for the graft surface, the blood and aortic wall surfaces are flat and without significant irregularities or extensions.
  • the angle between the side and hypotenuse measures 30 degrees and in the range of 20°-40°.
  • This edge or angle between the blood and aortic wall surfaces is rounded with a radius of curvature in the range of 0.35 mm to 0.5 mm.
  • the graft surface 14d is a complex geometrical surface.
  • Two rows of spikes 14f and 14g project towards the central axis of the ringflange from the graft surface in FIGS. 1 and 2 where the spikes are uniformly distributed in two rows around the central aperture. While there are substantially ten spikes in each row, by way of example and for purposes of illustration only, and not to be construed as limiting of the present invention, there can be a lesser or greater number of spikes in both rows.
  • the number of spikes per row can range from 4 to 15 depending upon the diameter 14b of the central aperture and width of each of the spikes at the base 14d.
  • the spikes of row 14g are substantially twice the size (base, height and width) as the spikes of the row 14f.
  • the longer spikes 14g of a ringflange measure 0.58 mm while the shorter length spikes 14f measure about 0.33 mm.
  • the spikes 14f and 14g can be described as having the shape of a right cone with the tip of the spike being the apex of the cone where each spike has a substantially apex or vertex angle of 50 degrees.
  • Representative external dimensions of the ringflange 14 by way of example include an external diameter of 10.00 mm, a central aperture diameter of 5.65 mm and a thickness that measures 1.75 mm.
  • Representative external dimensions of the ringflange 14 include an external diameter of 10.00 mm, a central aperture diameter of 5.65 mm and a thickness that measures 1.75 mm.
  • Several sizes of anastomotic fittings are required because grafts of varying dimensions are frequently encountered during coronary bypass surgery. Therefore, the measurements of the ringflange substantially range as follows: 7.0 mm to 15.0 mm outside diameter, 4.65 mm to 7.65 mm central aperture diameter and 1.25 mm to 2.75 mm thick.
  • the ringflange is not continous around its entire circumference as a slit 14h of very small width of substantially 0.4 mm or less transects the cross-section.
  • This single slit 14h allows the ringflange 14 to be flexed or expanded providing for engagement on the tube 12 exhibiting characteristics as a spring clamp and including forceps holes 14i and 14j.
  • the cross-section of the ringflange 14 can be transected in two places resulting in a two-part component.
  • FIG. 3, which illustrates a sectional view taken along line 3-3 of FIG. 1 shows the fixation ring 16 is a circular member 16a having a concentric central aperture 16b.
  • the geometrical shape of the fixation ring 16 is that of a shallow truncated right cone having a vertex angle of substantially 120 degrees.
  • the outermost circumferential edge 16c as illustrated in FIG. 1 is rounded so that the inner surface blends smoothly with the duter surface.
  • the surface 16d of the central aperture is flat and substantially perpendicular to the central axis of the fixation ring 16.
  • the outer surface 16e of the fixation ring 16 is generally smooth and without significant irregularities or projections. Both inner and outer surfaces are parallel to each other, but parallelism is not essential or required.
  • a wide surface locking ring abutment margin 16e measures about 1 mm wide and concentrically encircles the central aperture. The plane of this wide surface margin 16e is parallel to the narrower margin 16d on the opposite side of the central aperture and is normal to the central axis of the fixation ring.
  • the measurements of a representative fixation ring are as follows: 12.0 mm outside diameter, 5.1 mm central aperture diameter, and 1.25 mm wall thickness. Because grafts of varying dimensions are used as coronary artery bypass grafts, several sizes of anastomotic fittings are required. Therefore, the measurements of the fixation ring 16 can range on both sides of the representative figures set forth above as follows: 8.0 mm to 16.0 mm outer diameter, 4.1 mm to 7.1 mm central aperture diameter, and 0.4 mm to 2.0 mm wall thickness.
  • the central aperture diameter 16b is slightly larger than the outside diameter of the tube 12.
  • a plurality of individual spikes extend from a spiked aortic wall inner surface 16f of the fixation ring 16 where the spikes project parallel to the central axis of the fixation ring 16. While the spikes are of the same length and are arranged into two concentric circular rows in an innermost row 16g and an outermost row 16h, it is not essential that all of the spikes be of the same length or arranged in concentric circular rows as such is by way of example and for purposes of illustration only. The tips 16j of the spikes in the outermost row extend beyond the conical base plane of the fixation ring 16.
  • the outermost circular row 16h of spikes is located about 1mm from the outermost peripheral circumference of the fixation ring 16 and the innermost circular row 16g of spikes is located between 1mm and 2mm from the circumferential edge of the central aperture.
  • Each of the spikes is conical in shape having a vertex angle of about 20° and having a length 0.8mm to 1.0mm in length, but conical shape is not essential for operation.
  • FIG. 4 which illustrates a sectional view taken along line 4-4 of FIG. 1, shows the locking ring 18 including circular member 18a with a concentric aperture 18b.
  • the locking ring 18 includes an outer circumferential surface 18c which in FIG. 1 is flat and parallel to the central axis of locking ring 18. Both edges 18d and 18e of the circumferential surface are rounded with radii of 0.25mm and 0.75mm respectively and the plane of each face of the locking ring 18 is normal to the central axis where the planes of the two faces are parallel.
  • the central aperture 18b includes three concentric ridges 18f. Two of the three ridges 18f.1 and 18f.2 are the mirror image of the locking ring grooves 12e found on the external surface of the tube 12.
  • the width of the locking ring 18 is the additive result of three locking ring grooves 18f and the width of the narrow leading edge margin 18g.
  • the central aperture 18b are most important to achieve a proper assembled result between the components of the anastomotic fitting 10, the aortic wall 22 and the graft 20. None of the external dimensions are critical to the end result except that the locking ring 18 retain structural integrity and firmness when in assembled relationship with the other component parts of the anastomotic fitting 10. Several sizes of this anastomotic fitting are necessary because grafts of varying dimensions are frequently encountered during coronary bypass surgery and therefore, the dimensions range in accordance with different size fittings.
  • the locking ring 18 is not continuous around its entire circumference.
  • a slit 18h of very small width of about 0.4mm or less transects the cross-section and includes forceps holes 1 0i and 18 j positioned about either side. This single slit 18h allows the locking ring 18 to be flexed or expanded providing easy assembly on the tube 12. In this way the locking ring 18 behaves as a spring clamp.
  • Each component 12-18 of the four component anastomotic fitting 10 as well as the assembled anastomotic fitting 10 must exhibit predetermined physical, mechanical and dimensional characteristics. A number of the characteristics can be inherent in the construction material. These features include radio-translucence, blood compatability, tissue compatibility; light weight and small size.
  • the tube 12 and fixation ring 14 are passive components.
  • the ringflange 16 and locking ring 18 are active components that need to be flexed or expanded during implant. Therefore, these latter components are constructed of material that exhibits a springlike quality and a permanent dimensional memory.
  • suitable construction materials for these components are Pyrolite, ceramic, sapphire, metals including titanium, tantalum, or stainless steel, etc., or plastics including Teflon, polycarbonate, polysulfone, polypropylene, etc.
  • Pyrolite, titanium, tantalum, stainless steel, Teflon, polycarbonate and polypropylene have all been previously utilized in medical products.
  • Pyrolite and titanium have recorded very suitable long-term histories as cardiovascular implant materials. Pyrolite exhibits an excellent spring-like quality, is fatigue resistant and has a permanent memory. The final selected construction material(s) of the components of this device will have been evaluated for these and other characteristics.
  • Anastomotic fitting or fittings which are to be implanted are predetermined by the location of the coronary artery blockage, surgical aceessibility of the downstream coronary arteries, and size of the downstream coronary arteries where a graft or grafts are implanted for best surgical result. While in most eases a surgeon will implant two or three bypass grafts in each patient who undergoes coronary artery bypass surgery, for purposes of illustration and for example only the description of the mode of operation is limited and directed to an implant of one bypass graft, and is not be construed as limiting of the present invention as the description can be extended to more than one bypass graft implant as required as illustrated in FIG. 5 or implant of a graft of a first diameter to a blood vessel of a second diameter as illustrated in FIG. 6, a sectional along line 6-6 of FIG. 5.
  • FIG. 5 illustrates a plan view of two anastomotic fittings 10 and 24 positioned in the aortic wall, and at an angular relationship with respect to each other.
  • the anastomotic fitting 10 of the present invention can be used to connect both biologic as well as synthetic vascular grafts to blood vessels of generally larger diameter.
  • a saphenous vein graft 20 is connected between the ascending aorta 22 and, remotely, to a coronary artery to bypass blood around a blocked coronary artery.
  • the connections of the saphenous vein graft to the aorta and coronary artery are known as the proximal anastomosis and distal anastomosis respectively.
  • This embodiment pertains to the proximal anastomosis for which the anastomotic fitting 10 is best suited. The following steps are necessary for assembling and installing the anastomotic fitting 10.
  • the inside diameter of the vein graft near the end that is attached to the aortic wall is gauged with a sizing-obturator.
  • the anastomotic fitting 10 is chosen whose tube 12 has an inside diameter that approximates the outside diameter of the vein graft.
  • the gauged end of the vein graft is passed through the tube 10 from the outflow end 12f to the inflow end 12d or, into the end with the numerous locking ring grooves and out of the end with the single ringflange indentation.
  • the leading end of the graft projecting through the inflow end of the tube is everted over the outside of the tube 10 for an approximate distance of three millimeters. Care is taken not to extend the graft over the locking ring grooves 12e.
  • the graft is trimmed about one millimeter short of the first locking ring groove.
  • the tubed/graft is ready to receive the ringflange 14.
  • a slit through the cross-section allows it to be expanded, the ringflange 14 is expanded using a surgical instrument such as a forceps.
  • the blood surface of the ringflange 14 is placed down on a firm flat surface.
  • the tapered ends of the forceps are inserted, each, into a hole located on either side of the slit 14, of the aortic wall surface.
  • the ring 14 is caused to expand by spreading or opening the forceps the same as one opens a pair of pliers.
  • the inflow end of the tubed-graft with the everted graft is placed into the expanded central aperture 14b of the ringflange 14. Care is taken to be certain that the end of the tubed-graft is in complete circular contact with, and perpendicular to, the firm flat surface beneath the ringflange 14.
  • the ringflange 14 and tubed-graft are then in correct spatial relation for engagement of the latter by the spikes 14f and 14g of the ringflange 14.
  • the opening force on the forceps and consequently on the ringflange is relaxed.
  • the spring-clamp characteristic of the ringflange 14 causes it to close and clasp the tube 12, in a firm positive manner.
  • Proper placement of the ringflange 14 occurs when the slit has returned to or near its preengagement relaxed width and the spikes 14f and 14g in both eneircling rows engage the surface of the tube 12.
  • the clasping characteristic of the ringflange 14 is expected to produce a satisfactory capture of the graft 20 and tube 12 from engagement by the spikes.
  • This assembly is now attached to the aortic wall.
  • a hole having a diameter equal to or slightly larger but not more than one millimeter larger than the outside diameter of the tube is made in the predetermined place in the aortic wall.
  • the hole is made using a hole-punch especially designed for this purpose.
  • the ringflange 14 is wetted with blood to facilitate and ease its passage through the smaller diameter aortic wall hole. Grasping the tube near its outflow end, the peripheral edge of the ringflange is positioned at the center of the hole and angled substantially 30 degrees relative to the plane of the hole. The leading peripheral edge of the ringflange is then advanced into the hole and with a firm continuous twisting motion and is engaged into the aortic lumen.
  • the free edge of the graft 20 may have to be adjusted and continuing, therefore, to grasp the outflow end 12f of the tube 12, the assembly is gently retracted until the ringflange 14 engages the inside of the aortic wall 22 causing the peripheral edge of the hole to bulge outward in response to the angulation of the aortic wall surface of the ringflange 14 as illustrated in FIG. 1.
  • the free-edge of the graft 20 is restored to its pre-insertion symmetry on the outside of the surface of the tube 12.
  • the proper lay of the graft and the relationship to the edge of the aortic wall hole is illustrated in FIG. 6.
  • the figure also illustrates the correct angulation of the periphery of the aortic wall hole 22a.
  • the outflow end of the graft is passed through the central aperture 16b of the fixation ring 16 from the base side 16k to the apex side 16m. Holding the entire length of the graft under gentle tension, the fixation ring 16 is then easily advanced from the distal end of the graft to the outflow end 12f of the tube 12 without entangling the graft in the long spikes 16h and 16g of the fixation ring 16.
  • the inside diameter of the central aperture of the fixation ring 16 is slightly larger than the outside diameter of the tube 12. This provides free movement of the fixation ring along the length of the tube.
  • the fixation ring is advanced from the outflow end of the tube to the aortic wall 22, but, it is not yet advanced against the aortic wall 22. Grasping the outflow end of the tube, the assembly is gently retracted normal to the plane of the hole resulting in centering and aligning the assembly of the ringflange and tube with the hole 22a in the aortic wall 22 and causing the aortic wall to be uniformly distributed over the surface of the hypotenuse 14e of the ringflange 14. Continuing, the fixation ring is advanced against the aortic wall and care is exercised in firmly pressing the fixation ring into complete contact with the aortic wall surface. Hence, all of the spikes 16g and 16h have penetrated their full allowable distance into the thickness of the aortic wall.
  • the average thickness of the aortic wall 22 is about 1.2 millimeters.
  • the tips of the spikes 16g and 16h of the fixation ring 16 remain within the tissue of the aortic wall. Therefore, the spikes are limited to a length of one millimeter or less.
  • the conical shape of the spike effectively impacts the spike in the aortic wall tissue and eliminates the possibility of blood escaping along its surface.
  • the area of impacted tissue around and along the length of the spike is small near the tip and becomes more broad near the base of the spike. However, none of the impacted tissue is isolated from the vascular bed in the aortic wall. Therefore, this tissue wfll remain viable.
  • a narrow circular margin, measuring two millimeters to three millimeters, of aortic tissue around the hole 22a is placed under constant but slight compression between opposing surfaces of the ringflange 14 and the fixation ring 16.
  • the free spaces between the aortic wall, the graft and the three components of the anastomotic fitting are markedly reduced, and can even be eliminated where the elimination of these spaces in combination with the sli ght compressive force placed on the thickness of the aortic wall virtually eliminates the possibility of blood leakage along the interface between the aortic wall and the ringflange 14 and on outward along the interface between the edge of the hole in the aortic wall and the surface of the graft.
  • the locking ring 18 is the last component of the anastomotic fitting 10 to be installed. Observing the correct orientation of the locking ring 18 relative to the tube 12, the outflow end or free end of the graft 20 is passed through the central aperture of the locking ring 18. Grasping the free end of the graft and extending its length, the locking ring 18 is advanced the length of the graft to the outflow end of the tube 12. The leading edge 18g of the central aperture diameter is slightly larger than the outside diameter of the tube 12. That provides for initial movement and placement of the locking ring 18 onto the tube 12. The slit 18h through the cross-section of the locking ring 18 is expanded by using the surgical instrument forceps.
  • the tapered ends of the forceps are inserted, each, into the holes 18i and 18j located on either side of the slit 18h of the distal surface.
  • the ring 18 expands by spreading or opening the forceps the same as one opens a pair of pliers. Holding the ring 18 open, the ring is advanced along the length of the tube until it engages in firm abutting contact with the fixation ring 16. Care is exercised not to further compress the tissue of the aortic wall than that which was first accomplished during the placement of the fixation ring; however, it is essential that the initial compressive status not be relaxed.
  • the ridges 18f.l-18f.3 engage in the grooves 12e as illustrated in FIG. 6.
  • the spring feature of the locking ring 18 provides component removable by the same technique used for positioning.
  • the clearance between the central aperture diameter of the fixation ring and the outside diameter of the tube permits the easy retraction of the fixation ring from the aortic wall and removal from the tube.
  • the partial assembly of the tubed-graft and ringflange can be removed from the hole in the aortic wall by instituting the insertion motion in reverse.
  • the ringflange can be removed from the end of the tube by, again, using the forceps to expand the ringflange. This provides removal of the tubed-graft from the ringflange.
  • FIG. 7 which illustrates a sectional view of an alternative embodiment of a three-component anastomotic fitting, shows a threecomponent anastomotic fitting 30.
  • the components of the three-component anastomotic fitting 30 include a tube 32, a ringflange 34, and a latchingfixation ring 36.
  • the tube 32 is of the same geometrical configuration as the tube 12 of the four-component anastomotic fitting but with two exceptions, where first, the tube 32 is about 10% shorter than tube 12 and second, the tube 32 can have one to three fewer latching grooves that encircle its downstream end 32f.
  • the ringflange 34 of the three-component anastomotic fitting is identical to the ringflange 14 of the four-component device described earlier in FIGS. 1-6.
  • the latehing-fixation ring 36 is the third component of the anastomotic fitting 30 where the fixation ring 16 and locking ring 18 of the four-component anastomotic fitting 10 are combined to form the latehing-fixation ring 36 of the three-component anastomotic fitting 30.
  • the latehing-fixation ring 36 exhibits the appearance of the fixation ring 16 described earlier but for two exceptions; one, the thickness of the central aperture from one side to the other is about 1/3 greater, and two, the surface of the central aperture has three concentric ridges that are dimensionally similar to those found in the central aperture of the locking ring 18 previously described in FIGS. 1-6.
  • FIG. 8 which illustrates a sectional view taken along line 8-8 of FIG. 7, shows the latehing-fixation ring where all numerals correspond to those elements previously described.
  • the latehing-fixation ring 36 includes the locking ring ridge 36o, the narrow graft surface margin 36d, the aperture 36b, the rounded edge 36a, and the plurality of spikes 36g and 36h including tips 36i and 36j.
  • the latehing-fixation ring 36 also includes a slit 36h providing for engagement onto the tube 32.
  • FIG. 8 shows slit 36h across the cross-section like that of the previously discussed locking ring 18.
  • the slit 36h enables expansion of the central aperture of the ring during engagement on the tube 32.
  • the latehing-fixation ring can include at least one or more concentric grooves on the surface of the central aperture for latching as previously described.
  • the slit 36h through the cross-section of the ring 36 may not be required depending upon the type of material and the desired physical and mechanical characteristics which the material exhibits.
  • FIG. 9 which illustrates a sectional view of an alternative embodiment of a four-component anastomotic fitting, shows the fourcomponent anastomotic fitting 50.
  • the components of the four-component anastomotic fitting 50 include a tube 52, a ringflange 54, a fixation ring 56, and a locking ring 58.
  • the four-component anastomotic fitting has substantially the same essential components as that of the anastomotic fitting of FIGS. 1- 6.
  • the components 52-54 include certain geometrical variations as now described.
  • the tube 52 and ringflange 54 exhibit the most notable geometrical variations.
  • the inflow end 52d of the tube 52 is slightly flared having a lip 52g, yielding a larger exposure of graft material 60 at the anastomotic ostium.
  • the structural geometrical variation of the tube 52 is reflected in the ringflange 54 which is modified for compatible engagement with the tube 52 and discussed in FIG. 9A. Consequently, the fixation ring 56 reflects slight but not essential geometrical modification from the previous fixation rings and the locking ring 58 is essentially unchanged.
  • the ringflange 54 includes a circular member 54a having a concentric central aperture 54b.
  • a graft surface 54d includes a plurality of spaced, short, generally rounded spikes 54f having a rounded indentation for engaging with the flared lip and long, rounded spikes 54g for engaging in the ringflange indentation 52c.
  • the vascular graft engages over the flared lip 52g about the graft surface 54d, between the short spikes 54f and the flared lip 52g, between the long spikes 54g and the locking indentation 52c, and slightly beyond the outer circumference of the ringflange 54 and adjacent to a margin 56d of the fixation ring 56.
  • the fixation ring 56 and the locking ring 58 are similar to those elements previously described, and explanation is referenced and incorporated herein.
  • FIG. 9A illustrates a sectional view of the ringflange 54 where all numerals correspond to those elements previously described.
  • the ringflange 54 includes a slit 54h as previously discussed.
  • the fixation ring can have material removed from the outer surface.
  • the ringflange, locking ring, and combined fixation-locking ring can include holes on each side of the transecting slit for accepting a tied suture, similar mechanical latch, or contoured opposing interface surface providing for locking of the opposing faces and can be any other geometrical shape than circular such as hexagonal or octagonal.

Abstract

Anastomotic fitting for coronary artery bypass graft surgery having an assembly of four components including a cylindrical tube (12) having at least one ringflange locking indentation (12c) in an inflow end and a plurality of locking ring grooves (12e) in an outflow end, a ringflange (14) having a central aperture (14b) and plurality of long and short spikes (14g, 14f) the long spikes (14g) engaging in the locking indentation (12c), with a graft engaged therebetween, a fixation ring (16) having a central aperture (16b) and a plurality of spikes (16g, 16h) positioned about the aperture, and a locking ring (18) having an aperture (18b) with a plurality of locking ring ridges (18f) for engagement with the locking ring grooves. At surgical implantation an aortic wall having a hole therein engages between the ringflange (14) and the fixation ring (16) and is held in position by the spikes (16g, 16h) of the fixation ring, and the four components engage together forming an integral anastomotic fitting. A first alternative embodiment includes a three-component anastomotic fitting having a combination fixation ringlocking ring (36). A second alternative embodiment includes a four-component anastomotic fitting having a slightly flared end (52d) at an inflow end yielding a larger exposure of graft material at the anastomotic ostium.

Description

ANASTOMOTIC FITTING
Technical Field
The present invention pertains to a surgical prosthesis, and, more particularly, pertains to an anastomotic fitting for connecting a vascular graft to the wall of the ascending aorta.
Background Art
Diseases affecting the cardiovascular system are either congenital or acquired. An acquired cardiovascular disease can result from living habits, infections or injuries during embryonic life, or at any time following birth. Some diseases primarily affect the blood vessels; others only the heart itself.
Atherosclerosis is the major disease that affects the blood vessels. This disease may have its beginnings early in life and is first noted as a thickening of the arterial walls. This thickening is an accumulation of fat, fibrin, cellular debris and calcium. The resultant narrowing of the internal lumen of the vessel is called stenosis. Vessel stenosis impedes and reduces blood flow. Hypertension and dysfunction of the organ or area of the body that suffered the impaired blood flow can result.
As the buildup on the interior wall of a vessel thickens, the vessel wall loses the ability to expand and contract. Also, the vessel loses its viability and becomes weakened and susceptible to bulging, also known as aneurysm. In the presence of hypertension or elevated blood pressure, aneurysms will frequently dissect and ultimately rupture.
Small vessels, such as the arteries that supply blood to the heart, legs, intestines and other areas of the body, are particularly susceptible to atherosclerotic narrowing. The loss of blood supply to the leg or segment of the intestine may result in gangrene. Atherosclerotic narrowing of the coronary arteries impedes, limits and in some instances prevents blood flow to regional areas of the heart. Depending upon its severity and location within the coronary circulation, pain, cardiac dysfunction or death may result.
Vascular complications produced by atherosclerosis, such as, stenosis, aneurysm, rupture and occlusion are, in the majority of cases, managed either medically or surgically. Control and elimination of hypertension is the more effective form of medical management. In cases in which atherosclerotic disease is advanced and the attendant complications jeopardize the health of the patient, surgical intervention is usually instituted.
Aneurysms and stenosis of major arteries are best corrected by a plastic reconstruction that does not require any synthetic graft or patch materials. However, if the disease is extensive and the vessel is no longer reliable, it is usually replaced by a graft. In such case, the involved vessel section is transected and removed and a synthetic patch, conduit or graft is sewn into place.
Medium sized arteries are operated on much the same as for large diameter vessels. But in some types of surgery where the replacement graft is of small diameter, handling and surgical placement of the graft is difficult. The internal diameter may be compromised due either to surgical technique or biological response. In some cases, the graft may become entirely occluded shortly after surgery.
Patients with coronary artery disease in which blood flow to part of the heart muscle has been compromised receive significant benefit from coronary artery bypass surgery. This type of surgery requires the use of grafts of small diameter. These grafts, the majority of which are biologic, have certain inherent problems. Synthetic grafts are only used on infrequent occasions because they are more problematical than biologic grafts. It is the purpose of this invention to obviate and eliminate certain of the more significant problems associated with the surgical procedure of coronary artery bypass and the implanted grafts following surgery.
In a patient who undergoes coronary artery bypass surgery, a non-critical artery or vein of small diameter is harvested from elsewhere in the body and sewn into place in a manner that reestablishes flow to the area of the heart that earlier lost its blood supply because of atherosclerotic blockage and is referred to as an autograft. When no suitable artery or vein can be harvested, an allograft or xenograft vessel may be employed. However, experience with these latter two graft types is limited because of unsatisfactory results. A synthetic graft is an alternative to an allograft or a xenograft. But, like the allograft and xenograft, the synthetic counterpart does not produce acceptable results.
Although the heart benefits immediately from the reestablished blood supply of the bypass, there is no assurance the graft will function trouble free indefinitely. The autograft, because It is harvested from the patient, who in all probability is being operated on for atherosclerotic artery disease, is highly susceptible to atherosclerosis following surgery. Most harvested veins used in coronary artery bypass surgery exhibit some degree of atherosclerosis.
The long vein in the leg called the saphenous vein is the most commonly harvested vein for use as a vein bypass graft, in coronary artery surgery. Most saphenous vein bypass grafts, in time, exhibit a narrowing of the lumen unlike that of atherosclerosis. It is believed this is a pathologic response of the vein because it is of different cellular construction and composition than an artery—a condition for which it is not best suited. Harvesting a saphenous vein autograft is a tedious surgical task and not always rewarded with the best quality graft. Also, removal of the saphenous vein disrupts the natural venous blood return from the leg and is not therapeutically recommended except for medical reasons such as in a patient with advanced venous disease such as varicose veins. Finally, harvesting an autograft in the operating room requires additional surgical time and expense.
These noted limitations of the saphenous vein autograft have generated interest in a synthetic graft for coronary artery bypass. Clinical experience with small diameter synthetic grafts for coronary artery bypass dates back to the mid 1970's. Teflon and Dacron fibers are the most commonly employed materials for synthetic grafts. However, despite the different methods and techniques of graft construction such as woven or knit, velour, texturized or non-texturized, tight or loose, fine or coarse, expanded or non-expanded, variations in fiber diameter and wall thickness, etc., no graft of small lumen diameter has shown a resistance to blockage by thrombus. However, synthetic grafts of large diameter consistently remain patent and trouble-free for extended periods of many years. This finding is consistently repeated where a small-diameter synthetic graft is used to bypass a blocked coronary artery. Therefore, despite their inherent limitations, autografts employing the saphenous vein remain the graft of choice for coronary artery bypass surgery.
The coronary artery circulation begins with the right and left coronary arteries. These two arteries in turn give rise to an extensive coronary circulation. Generally, atherosclerosis affects the larger coronary arteries. Therefore, a patient being operated upon for coronary artery disease will receive two or more vein grafts of various length and diameter depending upon the location of the blockage and the usable harvested saphenous vein. Even though coronary artery bypass surgery is widely practiced and has become a routine procedure in hospitals throughout the world, it is not without certain operative limitations that would best be avoided. Sewing the graft to host vessel, known as an anastomosis, requires delicate surgical techniques to accomplish the best possible result. There are several complications to be avoided when anastomosing a vessel and graft together. It is important that the junction between the host tissue and graft be a uniform transition without narrowing and regional irregularities such as protuberances that bulge into the lumen or sinuses that extend outward of the lumen. A narrowing at the site of anastomosis reduces blood flow. Protuberances into the lumen obstruct blood flow and may produce turbulence. Lastly, blood that stagnates in a sinus or cavity tends to clot and obstruct the vessel lumen and subsequently the blood flow. All these characteristics diminish the effectiveness and patency of the graft.
Summarizing, the limitations associated with the autograft as applied in coronary artery bypass surgery are: tedious surgical task to harvest, physically imperfect and irregular lumen, tedious surgical task to anastomose to host vessel, physically imperfect anastomosis of irregular and unsmooth transition between graft and vessel, functional narrowing of vein graft lumen during early postoperative period, and occlusion of the autograft due to thrombosis and/or continuance of the preexisting atherosclerotic process.
Summary Disclosure of Invention
The anastomotic fitting of the present invention provides a device simplifying the surgical task of implanting coronary artery bypass grafts and of connecting two vessels to each other. The anastomotic fitting provides a connection between the ascending aorta and a graft with smooth wall contours that are not obstructive to the natural flow of the blood.
The general purpose of the present invention is an anastomotic fitting for connecting a vascular graft to the ascending aorta, and providing for a uniform ostium having a smooth surface throughout from the aortic wall to the graft. The anastomotic fitting accepts either a saphenous vein graft or a synthetic vascular graft, and is utilized in connecting a vascular graft of a first diameter to a blood vessel of a second diameter. While the blood vessel of a first diameter is usually of a lesser diameter than a blood vessel of a second diameter, the vessels can be of equal diameters or, in the alternative, the first diameter can be greater than a second lesser diameter. The anastomotic fitting includes a cylindrical tube through which the vascular graft engages and overlaps at an inflow end where a ringflange spatially engages the overlapped end with the inflow end of the tube. The anastomotic fitting engages in position in a hole in the aortic wall by the ringflange engaging against the inside aortic wall about the hole and by the fixation ring including a plurality of outward extending spikes engaging against the outside aortic wall about the hole.
According to one embodiment of the present invention, there is provided an anastomotic fitting for connection between an aortic wall and a vascular graft including a cylindrical tube having a lumen extending therethrough, a ringflange circumferential indentation adjacent an inflow end of the tube and a plurality of locking ring grooves adjacent an outflow end of the tube; a ringflange having a circular member with a concentric central aperture larger than the outer diameter of the tube therethrough, and a triangular right-angle cross-section where the base is substantially parallel to the aortic wall, the hypotenuse engages against the inside aortic wall surface and the base includes a plurality of inwardly extending short and long spikes, the short spikes engaging the vascular graft at a plurality of points and the long spikes engaging through the vascular graft into the ringflange indentation; a fixation ring having a circular member with a central aperture therethrough and a truncated cone cross-section and pluralities of rows of outwardly extending spikes, the spikes partially engaging into the outside aortic wall, and the central aperture larger than the outer diameter of the tube; and, a locking ring having a circular member with a central aperture slightly larger than the outer diameter of the tube, and a plurality of inwardly extending locking ring ridges whereby a hole is surgically positioned in the aortic wall, the vascular graft is positioned through the tube and overlapped about the inflow end, the ringflange is engaged about the overlapped end and into the ringflange locking indentation, the partially assembled fitting is inserted and engaged within the hole and against the inside of the aortic wall, the fixation ring is engaged about the tube and against the outside of the aortic wall, and the locking ring is engaged against the locking grooves of the tube thereby providing for communication of the vascular graft with the aorta, and the other end of the vascular graft is surgically sutured to a remote artery or connects to another anastomotic fitting of different configurations positioned in a remote artery. According to another alternative embodiment of the present invention, there is provided an anastomotic fitting including a combined fixation-locking ring whereby the fixation ring and locking ring of the previous embodiment described above are incorporated into a single integral unit thereby providing a three-component anastomotic fitting.
According to an additional embodiment of the present invention, there is provided an anastomotic fitting including a tube with a flared end, a ringflange which engages a vascular graft between short spikes of the ringflange and the flared end and long spikes of the ringflange and a circumferential ringflange indentation in the tube, a fixation ring, and a locking ring thereby providing a four-component anastomotic fitting structurally similar to that of the anastomotic fitting previously described.
Vascular graft is encompassing in definition including biologic grafts being either human or animal and synthetic grafts, and is not to be construed as limited to a saphenous vein graft which is discussed by way of example and for purpos.s of illustration only. Synthetic grafts can include woven materials of synthetic plastics, processed biologic materials, or composite metals.
One significant aspect and feature of the present invention is a precision ostium providing for facilitated surgical implantation, and safety and efficacy in vivo. The precision nature of the ringflange with engagement of the inflow orifice of the tube provides a high-quality and consistent ostium. The ringflange lies flat against the inside of the aortic wall and the peripheral edges are rounded, thereby reducing turbulence and aortic flow velocity. The resultant ostium exhibits surface contours of least variation from the aortic wall to the vascular graft. On account of the minimal surface projection of the ringflange, there results a full orifice ostium and a nonrestrϊctive direct flow path from the aorta. Coronary hemodynamics are superior to that of conventional hand-stitched anastomosis. The anastomotic fitting includes geometrical components that engage in a predetermined relationship forming an integral unit, and that are subject to no movement following surgical implant. The 90° angle of exit from the aorta ensures maximum protection against thrombosis. In the event the aorta is thickened and/or calcified from extensive atherosclerotic disease, the anastomotic fitting provides for safe and effective attachment of a vascular graft. Another significant aspect and feature of the present invention is an anastomotic fitting that provides for least surgical implant time and motion, that minimizes the influence of tissue and operative variables. The steps required for surgically implanting the anastomotic fitting are simple, least time consuming, and more readily mastered than that of creating an anastomosis with a saphenous vein by the tedious hand-stitching methods. The resultant ostium is always circular and includes smooth inflow contours. A further significant aspect and feature of the present invention is an anastomotic fitting which can be installed in less time, with greatest efficiency, and the utilization of fewest consumable supplies, equipment and expense. The assembled component anastomotic fitting assures a tight, patent anastomotic fitting that enables both the aortic wall tissue around the hole and the saphenous vein if utilized to receive nutrients from the blood and remain viable. If for any reason the anastomotic fitting requires reinstallation, relocation, or removal, the fitting can readily and easily be removed in least time without damage to surrounding tissue of the aortic wall about the hole. Most importantly, the anastomotic fitting is adjustable to the friability of the aortic wall.
Having thus described the invention, it is a. principal object hereof to provide an anastomotic fitting for connecting or reconnecting a vascular graft of first diameter to a blood vessel of second diameter, particularly in coronary artery bypass surgery.
An object of the present invention is an entire blood flow path which is constructed of natural material. The entire blood flow path from the ostium that confronts the aortic lumen and onward over the entire length of the bypass graft is the natural blood compatible surface of the lumen of the saphenous vein. Inverting the saphenous vein graft over the end of the tube produces a superior anastomotic ostium. The ringflange is the only minimal foreign surface exposed to the blood and presents no adverse effect or influence on the long-term patency of the ostium or graft, especially when constructed of the highly blood-compatible material Pyrolite.
Another object of the present invention is an anastomotic fitting providing an unimpeded blood flow path of smooth transitional flow contours that reduces the effects of turbulence. The ringflange that engages against the internal aortic wall provides minimal blood flow obstruction, turbulence and stagnation. The anastomotic fitting also provides an external configuration that conforms with adjacent vessels and the limited available space in the chest cavity in the region of the heart. Another object of the present invention is an anastomotic fitting including a ringflange that accepts vascular grafts including saphenous vein grafts of widely varying thickness. The ringflange effectively engages saphenous vein grafts of a wide range of thicknesses and retains the grafts in frictionally engaged surface contact with the inflow end of the tube providing for unrestricted, natural circulation throughout the engaged tissues. Also the ringflange and fixation collar accept varying thicknesses of the aortic wall. The full orifice ostium is not narrowed and is not obstructive to blood flow from the aorta into the graft.
An additional object of the present invention is a patent lumen providing support for the full orifice anastomotic ostium where the tube also provides shielding protection for the first several millimeters of the graft. This prevents external forces such as intrathoracic pressures, blood flow pulsations and twisting of the graft from impinging on the anastomosis or first few millimeters of the graft. This reduces the potential narrowing of the ostium and occlusion of the lumen.
A further object of the present invention is an anastomotic fitting that engages the hole surrounding the aortic wall and that of the saphenous vein OF other biologic tissue vascular graft resulting in uninterrupted vascular circulation and blood supply to the tissues. The tissues therefore remain viable and the efficacy of the anastomosis is preserved.
Brief Description of the Drawings
Other objects and many of the attendant advantages of this invention will be readily appreciated as the same becomes better understood, by reference to the following detailed description when considered in connection with the accompanying drawings, in which like reference numerals designate like parts throughout the figures thereof and wherein:
FIG. 1' illustrates an exploded view of an anastomotic fitting including a tube, a ringflange, a fixation ring, and a locking ring where the tube is engaged through a hole in the aortic wall and a saphenous vein is engaged therebetween;
FIG. 2 illustrates a sectional view taken along line 2-2 of FIG.1;
FIG. 3 illustrates a sectional view taken along line 3-3 of FIG.1;
FIG. 4 illustrates a sectional view taken along line 4-4 of FIG.1; FIG. 5 illustrates two anastomotic fittings positioned in the aortic wall;
FIG. 6 illustrates a sectional view taken along line 6-6 of FIG.
FIG. 7 illustrates a sectional view of an alternative embodiment of a three-component anastomotic fitting;
FIG. 8 illustrates a sectional view taken along line 8-8 of FIG.
7;
FIG. 9 illustrates a sectional view of an alternative embodiment of an anastomotic fitting; and,
FIG. 9A illustrates a sectional view taken along line 9A-9A of
FIG. 9.
Preferred Mode For Carrying Out the Invention
FIG. 1, which illustrates an exploded view of the components of an anastomotic fitting 10 of the present invention, shows an anastomotic fitting 10 including tube 12, ringflange 14, a fixatibn ring 16 and a locking ring 18, about a saphenous vein 20 and engaged in a hole 22a in an aortic wall 22 having a hole 22a where all elements are now described in detail.
The tube which is a short hollow right cylinder 12a having an internal surface which is smooth and both ends 12b and 12c which are rounded having a radius of curvature equal to one-half of the wall thickness. Concentric grooves are disposed on an external surface as now described. One type, a ringflange indentation 12e is positioned substantially within 2 millimeters (mm) of the inflow end 12d of the tube. The bottom of the groove 12c is rounded and the sides of the groove are angled approximately 30 degrees to the plane normal to the central axis of the tube 12.
Locking ring grooves 12e including a plurality of identical grooves in the range of the five to ten extend about half of the external surface of the tube from the mid-region to the outflow end 12f and have a geometrical saw-tooth configuration. One side of each groove is substantiall y normal, 85 degrees to 95 degrees, to the central axis of the tube 12. The other side of each of these grooves is inclined at an angle of 15 degrees to the central axis or in the range of 10°-20° .
A representative tube 12 substantially measures 8.0 mm in length, 5.0 mm across its outside diameter, 3.5 mm across its inside diameter and 0.75 mm of wall thickness. Because grafts with varying dimensions are used as coronary artery bypass grafts, several sizes of anastomotic fittings including the tube 12 are required. Therefore, the range of dimensions of the tube 12 substantially encompass the following: 5.0 mm to 10.0 mm in length, 4.0 mm to 7.0 mm across the outside diameter, 2.5 mm to 5.5 mm across the inside diameter, and 0.6 mm to 1.5 mm of wall thickness.
FIG. 2, which illustrates a sectional view taken along line 2-2 of FIG. 1, shows the ringflange 14 including a circular member 14a with a concentric central aperture 14b. The surfaces of the ringflange 14 are best disclosed by viewing the cross-sectional view seen of FIG. 1 in light of FIG. 2. The cross-sectional geometry is that of a right triangle with the side of the triangle being equal to or longer than the base. In respect to the three sides of a triangle, the side is known as the blood surface 14c, the base is referred to as the graft surface 14d and the hypotenuse as the aortic wall surface 14e. Except for the graft surface, the blood and aortic wall surfaces are flat and without significant irregularities or extensions. The angle between the side and hypotenuse measures 30 degrees and in the range of 20°-40°. This edge or angle between the blood and aortic wall surfaces is rounded with a radius of curvature in the range of 0.35 mm to 0.5 mm. Structurally, the graft surface 14d is a complex geometrical surface. Two rows of spikes 14f and 14g project towards the central axis of the ringflange from the graft surface in FIGS. 1 and 2 where the spikes are uniformly distributed in two rows around the central aperture. While there are substantially ten spikes in each row, by way of example and for purposes of illustration only, and not to be construed as limiting of the present invention, there can be a lesser or greater number of spikes in both rows. The number of spikes per row can range from 4 to 15 depending upon the diameter 14b of the central aperture and width of each of the spikes at the base 14d. Generally, the spikes of row 14g are substantially twice the size (base, height and width) as the spikes of the row 14f. Typically, the longer spikes 14g of a ringflange measure 0.58 mm while the shorter length spikes 14f measure about 0.33 mm. The spikes 14f and 14g can be described as having the shape of a right cone with the tip of the spike being the apex of the cone where each spike has a substantially apex or vertex angle of 50 degrees.
Representative external dimensions of the ringflange 14 by way of example include an external diameter of 10.00 mm, a central aperture diameter of 5.65 mm and a thickness that measures 1.75 mm. Several sizes of anastomotic fittings are required because grafts of varying dimensions are frequently encountered during coronary bypass surgery. Therefore, the measurements of the ringflange substantially range as follows: 7.0 mm to 15.0 mm outside diameter, 4.65 mm to 7.65 mm central aperture diameter and 1.25 mm to 2.75 mm thick.
The ringflange is not continous around its entire circumference as a slit 14h of very small width of substantially 0.4 mm or less transects the cross-section. This single slit 14h allows the ringflange 14 to be flexed or expanded providing for engagement on the tube 12 exhibiting characteristics as a spring clamp and including forceps holes 14i and 14j. Alternatively, the cross-section of the ringflange 14 can be transected in two places resulting in a two-part component.
FIG. 3, which illustrates a sectional view taken along line 3-3 of FIG. 1 shows the fixation ring 16 is a circular member 16a having a concentric central aperture 16b. The geometrical shape of the fixation ring 16 is that of a shallow truncated right cone having a vertex angle of substantially 120 degrees. The outermost circumferential edge 16c as illustrated in FIG. 1 is rounded so that the inner surface blends smoothly with the duter surface. The surface 16d of the central aperture is flat and substantially perpendicular to the central axis of the fixation ring 16. The outer surface 16e of the fixation ring 16 is generally smooth and without significant irregularities or projections. Both inner and outer surfaces are parallel to each other, but parallelism is not essential or required. A narrow graft surface margin 16d of approximately 0.2 mm width concentrically encircles the central aperture. The plane of this surface margin is normal to the central axis of the fixation ring. A wide surface locking ring abutment margin 16e measures about 1 mm wide and concentrically encircles the central aperture. The plane of this wide surface margin 16e is parallel to the narrower margin 16d on the opposite side of the central aperture and is normal to the central axis of the fixation ring.
The measurements of a representative fixation ring are as follows: 12.0 mm outside diameter, 5.1 mm central aperture diameter, and 1.25 mm wall thickness. Because grafts of varying dimensions are used as coronary artery bypass grafts, several sizes of anastomotic fittings are required. Therefore, the measurements of the fixation ring 16 can range on both sides of the representative figures set forth above as follows: 8.0 mm to 16.0 mm outer diameter, 4.1 mm to 7.1 mm central aperture diameter, and 0.4 mm to 2.0 mm wall thickness. The central aperture diameter 16b is slightly larger than the outside diameter of the tube 12.
A plurality of individual spikes extend from a spiked aortic wall inner surface 16f of the fixation ring 16 where the spikes project parallel to the central axis of the fixation ring 16. While the spikes are of the same length and are arranged into two concentric circular rows in an innermost row 16g and an outermost row 16h, it is not essential that all of the spikes be of the same length or arranged in concentric circular rows as such is by way of example and for purposes of illustration only. The tips 16j of the spikes in the outermost row extend beyond the conical base plane of the fixation ring 16. The outermost circular row 16h of spikes is located about 1mm from the outermost peripheral circumference of the fixation ring 16 and the innermost circular row 16g of spikes is located between 1mm and 2mm from the circumferential edge of the central aperture. In this embodiment, there are twice the number of spikes in the outermost row 16h than in the innermost row 16g, but this is not essential for operation. Each of the spikes is conical in shape having a vertex angle of about 20° and having a length 0.8mm to 1.0mm in length, but conical shape is not essential for operation.
FIG. 4, which illustrates a sectional view taken along line 4-4 of FIG. 1, shows the locking ring 18 including circular member 18a with a concentric aperture 18b. The locking ring 18 includes an outer circumferential surface 18c which in FIG. 1 is flat and parallel to the central axis of locking ring 18. Both edges 18d and 18e of the circumferential surface are rounded with radii of 0.25mm and 0.75mm respectively and the plane of each face of the locking ring 18 is normal to the central axis where the planes of the two faces are parallel. The central aperture 18b includes three concentric ridges 18f. Two of the three ridges 18f.1 and 18f.2 are the mirror image of the locking ring grooves 12e found on the external surface of the tube 12. On the leading edge of the third ridge 18f.3 is a narrow margin 18g whose diameter is slightly larger, of 0.1mm or more, than the outside diameter of the tube 12. Consequently, the width of the locking ring 18 is the additive result of three locking ring grooves 18f and the width of the narrow leading edge margin 18g.
Dimensions of the central aperture 18b are most important to achieve a proper assembled result between the components of the anastomotic fitting 10, the aortic wall 22 and the graft 20. None of the external dimensions are critical to the end result except that the locking ring 18 retain structural integrity and firmness when in assembled relationship with the other component parts of the anastomotic fitting 10. Several sizes of this anastomotic fitting are necessary because grafts of varying dimensions are frequently encountered during coronary bypass surgery and therefore, the dimensions range in accordance with different size fittings.
Like the ringflange 14, the locking ring 18 is not continuous around its entire circumference. A slit 18h of very small width of about 0.4mm or less transects the cross-section and includes forceps holes 1 0i and 18 j positioned about either side. This single slit 18h allows the locking ring 18 to be flexed or expanded providing easy assembly on the tube 12. In this way the locking ring 18 behaves as a spring clamp.
Each component 12-18 of the four component anastomotic fitting 10 as well as the assembled anastomotic fitting 10 must exhibit predetermined physical, mechanical and dimensional characteristics. A number of the characteristics can be inherent in the construction material. These features include radio-translucence, blood compatability, tissue compatibility; light weight and small size. The tube 12 and fixation ring 14 are passive components. The ringflange 16 and locking ring 18 are active components that need to be flexed or expanded during implant. Therefore, these latter components are constructed of material that exhibits a springlike quality and a permanent dimensional memory.
Some of the suitable construction materials for these components are Pyrolite, ceramic, sapphire, metals including titanium, tantalum, or stainless steel, etc., or plastics including Teflon, polycarbonate, polysulfone, polypropylene, etc. Pyrolite, titanium, tantalum, stainless steel, Teflon, polycarbonate and polypropylene have all been previously utilized in medical products. Pyrolite and titanium have recorded very suitable long-term histories as cardiovascular implant materials. Pyrolite exhibits an excellent spring-like quality, is fatigue resistant and has a permanent memory. The final selected construction material(s) of the components of this device will have been evaluated for these and other characteristics.
Mode of Operation
Anastomotic fitting or fittings which are to be implanted are predetermined by the location of the coronary artery blockage, surgical aceessibility of the downstream coronary arteries, and size of the downstream coronary arteries where a graft or grafts are implanted for best surgical result. While in most eases a surgeon will implant two or three bypass grafts in each patient who undergoes coronary artery bypass surgery, for purposes of illustration and for example only the description of the mode of operation is limited and directed to an implant of one bypass graft, and is not be construed as limiting of the present invention as the description can be extended to more than one bypass graft implant as required as illustrated in FIG. 5 or implant of a graft of a first diameter to a blood vessel of a second diameter as illustrated in FIG. 6, a sectional along line 6-6 of FIG. 5.
FIG. 5 illustrates a plan view of two anastomotic fittings 10 and 24 positioned in the aortic wall, and at an angular relationship with respect to each other.
The anastomotic fitting 10 of the present invention can be used to connect both biologic as well as synthetic vascular grafts to blood vessels of generally larger diameter. In this example, a saphenous vein graft 20 is connected between the ascending aorta 22 and, remotely, to a coronary artery to bypass blood around a blocked coronary artery. The connections of the saphenous vein graft to the aorta and coronary artery are known as the proximal anastomosis and distal anastomosis respectively. This embodiment pertains to the proximal anastomosis for which the anastomotic fitting 10 is best suited. The following steps are necessary for assembling and installing the anastomotic fitting 10.
The inside diameter of the vein graft near the end that is attached to the aortic wall is gauged with a sizing-obturator. The anastomotic fitting 10 is chosen whose tube 12 has an inside diameter that approximates the outside diameter of the vein graft. The gauged end of the vein graft is passed through the tube 10 from the outflow end 12f to the inflow end 12d or, into the end with the numerous locking ring grooves and out of the end with the single ringflange indentation. The leading end of the graft projecting through the inflow end of the tube is everted over the outside of the tube 10 for an approximate distance of three millimeters. Care is taken not to extend the graft over the locking ring grooves 12e. If necessary, the graft is trimmed about one millimeter short of the first locking ring groove. The tubed/graft is ready to receive the ringflange 14. Remembering that a slit through the cross-section allows it to be expanded, the ringflange 14 is expanded using a surgical instrument such as a forceps. The blood surface of the ringflange 14 is placed down on a firm flat surface. The tapered ends of the forceps are inserted, each, into a hole located on either side of the slit 14, of the aortic wall surface. The ring 14 is caused to expand by spreading or opening the forceps the same as one opens a pair of pliers. The inflow end of the tubed-graft with the everted graft is placed into the expanded central aperture 14b of the ringflange 14. Care is taken to be certain that the end of the tubed-graft is in complete circular contact with, and perpendicular to, the firm flat surface beneath the ringflange 14. The ringflange 14 and tubed-graft are then in correct spatial relation for engagement of the latter by the spikes 14f and 14g of the ringflange 14. The opening force on the forceps and consequently on the ringflange is relaxed. The spring-clamp characteristic of the ringflange 14 causes it to close and clasp the tube 12, in a firm positive manner. All of the spikes 14f and 14g projecting from the graft surface of the ringflange penetrate the thickness of the graft 20 and engage the surface of the tube 12. The tips of the smaller spikes 14f puncture the graft and immediately engage" the external surface of the tube 12. A substantial portion of the tip end of the larger spikes 14g penetrates the graft thickness. The tips come to rest in the bottom of the ringflange indentation 12c. Proper placement of the ringflange 14 occurs when the slit has returned to or near its preengagement relaxed width and the spikes 14f and 14g in both eneircling rows engage the surface of the tube 12. The clasping characteristic of the ringflange 14 is expected to produce a satisfactory capture of the graft 20 and tube 12 from engagement by the spikes. This assembly is now attached to the aortic wall. A hole having a diameter equal to or slightly larger but not more than one millimeter larger than the outside diameter of the tube is made in the predetermined place in the aortic wall. The hole is made using a hole-punch especially designed for this purpose.
Because blood is an excellent lubricant, and is readily accessible in the operative field, the ringflange 14 is wetted with blood to facilitate and ease its passage through the smaller diameter aortic wall hole. Grasping the tube near its outflow end, the peripheral edge of the ringflange is positioned at the center of the hole and angled substantially 30 degrees relative to the plane of the hole. The leading peripheral edge of the ringflange is then advanced into the hole and with a firm continuous twisting motion and is engaged into the aortic lumen. As a result, the free edge of the graft 20 may have to be adjusted and continuing, therefore, to grasp the outflow end 12f of the tube 12, the assembly is gently retracted until the ringflange 14 engages the inside of the aortic wall 22 causing the peripheral edge of the hole to bulge outward in response to the angulation of the aortic wall surface of the ringflange 14 as illustrated in FIG. 1. With a pair of forceps or similar surgical instrument, the free-edge of the graft 20 is restored to its pre-insertion symmetry on the outside of the surface of the tube 12. The proper lay of the graft and the relationship to the edge of the aortic wall hole is illustrated in FIG. 6. The figure also illustrates the correct angulation of the periphery of the aortic wall hole 22a.
Next, the outflow end of the graft is passed through the central aperture 16b of the fixation ring 16 from the base side 16k to the apex side 16m. Holding the entire length of the graft under gentle tension, the fixation ring 16 is then easily advanced from the distal end of the graft to the outflow end 12f of the tube 12 without entangling the graft in the long spikes 16h and 16g of the fixation ring 16. The inside diameter of the central aperture of the fixation ring 16 is slightly larger than the outside diameter of the tube 12. This provides free movement of the fixation ring along the length of the tube.
The fixation ring is advanced from the outflow end of the tube to the aortic wall 22, but, it is not yet advanced against the aortic wall 22. Grasping the outflow end of the tube, the assembly is gently retracted normal to the plane of the hole resulting in centering and aligning the assembly of the ringflange and tube with the hole 22a in the aortic wall 22 and causing the aortic wall to be uniformly distributed over the surface of the hypotenuse 14e of the ringflange 14. Continuing, the fixation ring is advanced against the aortic wall and care is exercised in firmly pressing the fixation ring into complete contact with the aortic wall surface. Hence, all of the spikes 16g and 16h have penetrated their full allowable distance into the thickness of the aortic wall.
The average thickness of the aortic wall 22 is about 1.2 millimeters. In the surgically complete anastomotic fitting, it is desirable that the tips of the spikes 16g and 16h of the fixation ring 16 remain within the tissue of the aortic wall. Therefore, the spikes are limited to a length of one millimeter or less. The conical shape of the spike effectively impacts the spike in the aortic wall tissue and eliminates the possibility of blood escaping along its surface. The area of impacted tissue around and along the length of the spike is small near the tip and becomes more broad near the base of the spike. However, none of the impacted tissue is isolated from the vascular bed in the aortic wall. Therefore, this tissue wfll remain viable.
A narrow circular margin, measuring two millimeters to three millimeters, of aortic tissue around the hole 22a is placed under constant but slight compression between opposing surfaces of the ringflange 14 and the fixation ring 16. In effect, the free spaces between the aortic wall, the graft and the three components of the anastomotic fitting are markedly reduced, and can even be eliminated where the elimination of these spaces in combination with the sli ght compressive force placed on the thickness of the aortic wall virtually eliminates the possibility of blood leakage along the interface between the aortic wall and the ringflange 14 and on outward along the interface between the edge of the hole in the aortic wall and the surface of the graft.
The locking ring 18 is the last component of the anastomotic fitting 10 to be installed. Observing the correct orientation of the locking ring 18 relative to the tube 12, the outflow end or free end of the graft 20 is passed through the central aperture of the locking ring 18. Grasping the free end of the graft and extending its length, the locking ring 18 is advanced the length of the graft to the outflow end of the tube 12. The leading edge 18g of the central aperture diameter is slightly larger than the outside diameter of the tube 12. That provides for initial movement and placement of the locking ring 18 onto the tube 12. The slit 18h through the cross-section of the locking ring 18 is expanded by using the surgical instrument forceps. The tapered ends of the forceps are inserted, each, into the holes 18i and 18j located on either side of the slit 18h of the distal surface. The ring 18 expands by spreading or opening the forceps the same as one opens a pair of pliers. Holding the ring 18 open, the ring is advanced along the length of the tube until it engages in firm abutting contact with the fixation ring 16. Care is exercised not to further compress the tissue of the aortic wall than that which was first accomplished during the placement of the fixation ring; however, it is essential that the initial compressive status not be relaxed. The ridges 18f.l-18f.3 engage in the grooves 12e as illustrated in FIG. 6.
On an event that disassembly of the anastomotic fitting is required, the spring feature of the locking ring 18 provides component removable by the same technique used for positioning. The clearance between the central aperture diameter of the fixation ring and the outside diameter of the tube permits the easy retraction of the fixation ring from the aortic wall and removal from the tube. The partial assembly of the tubed-graft and ringflange can be removed from the hole in the aortic wall by instituting the insertion motion in reverse. Finally, the ringflange can be removed from the end of the tube by, again, using the forceps to expand the ringflange. This provides removal of the tubed-graft from the ringflange.
Alternative Embodiment-Three Component Anastomotic Fitting
FIG. 7, which illustrates a sectional view of an alternative embodiment of a three-component anastomotic fitting, shows a threecomponent anastomotic fitting 30. The components of the three-component anastomotic fitting 30 include a tube 32, a ringflange 34, and a latchingfixation ring 36. The tube 32 is of the same geometrical configuration as the tube 12 of the four-component anastomotic fitting but with two exceptions, where first, the tube 32 is about 10% shorter than tube 12 and second, the tube 32 can have one to three fewer latching grooves that encircle its downstream end 32f. The ringflange 34 of the three-component anastomotic fitting is identical to the ringflange 14 of the four-component device described earlier in FIGS. 1-6. The latehing-fixation ring 36 is the third component of the anastomotic fitting 30 where the fixation ring 16 and locking ring 18 of the four-component anastomotic fitting 10 are combined to form the latehing-fixation ring 36 of the three-component anastomotic fitting 30. Outwardly, the latehing-fixation ring 36 exhibits the appearance of the fixation ring 16 described earlier but for two exceptions; one, the thickness of the central aperture from one side to the other is about 1/3 greater, and two, the surface of the central aperture has three concentric ridges that are dimensionally similar to those found in the central aperture of the locking ring 18 previously described in FIGS. 1-6.
FIG. 8, which illustrates a sectional view taken along line 8-8 of FIG. 7, shows the latehing-fixation ring where all numerals correspond to those elements previously described. The latehing-fixation ring 36 includes the locking ring ridge 36o, the narrow graft surface margin 36d, the aperture 36b, the rounded edge 36a, and the plurality of spikes 36g and 36h including tips 36i and 36j. The latehing-fixation ring 36 also includes a slit 36h providing for engagement onto the tube 32.
Operation of the three-component anastomotic fitting 30 is similar to that as previously described for FIGS. 1-6 between the wall 42 and the graft 40. The latching-fixation ring in FIG. 8 shows slit 36h across the cross-section like that of the previously discussed locking ring 18. The slit 36h enables expansion of the central aperture of the ring during engagement on the tube 32. The latehing-fixation ring can include at least one or more concentric grooves on the surface of the central aperture for latching as previously described. However, the slit 36h through the cross-section of the ring 36 may not be required depending upon the type of material and the desired physical and mechanical characteristics which the material exhibits.
Alternative Embodiment-Four Component Anastomotic Fitting
FIG. 9, which illustrates a sectional view of an alternative embodiment of a four-component anastomotic fitting, shows the fourcomponent anastomotic fitting 50. The components of the four-component anastomotic fitting 50 include a tube 52, a ringflange 54, a fixation ring 56, and a locking ring 58. The four-component anastomotic fitting has substantially the same essential components as that of the anastomotic fitting of FIGS. 1- 6. However, the components 52-54 include certain geometrical variations as now described. The tube 52 and ringflange 54 exhibit the most notable geometrical variations. The inflow end 52d of the tube 52 is slightly flared having a lip 52g, yielding a larger exposure of graft material 60 at the anastomotic ostium. The structural geometrical variation of the tube 52 is reflected in the ringflange 54 which is modified for compatible engagement with the tube 52 and discussed in FIG. 9A. Consequently, the fixation ring 56 reflects slight but not essential geometrical modification from the previous fixation rings and the locking ring 58 is essentially unchanged. For purposes of brevity, and since simiar structural elements such as grooves, spikes, surfaces, etc., have been previously described, previous description is referenced herein.
The ringflange 54 includes a circular member 54a having a concentric central aperture 54b. A graft surface 54d includes a plurality of spaced, short, generally rounded spikes 54f having a rounded indentation for engaging with the flared lip and long, rounded spikes 54g for engaging in the ringflange indentation 52c. The vascular graft engages over the flared lip 52g about the graft surface 54d, between the short spikes 54f and the flared lip 52g, between the long spikes 54g and the locking indentation 52c, and slightly beyond the outer circumference of the ringflange 54 and adjacent to a margin 56d of the fixation ring 56. The fixation ring 56 and the locking ring 58 are similar to those elements previously described, and explanation is referenced and incorporated herein.
FIG. 9A illustrates a sectional view of the ringflange 54 where all numerals correspond to those elements previously described. The ringflange 54 includes a slit 54h as previously discussed.
Operation of the anastomotic fitting 50 is similar to that as previously described for FIGS. 1-6 which explanation is referenced and incorporated herein between the wall 62 and the graft 60.
Various modifications can be made to the anastomotic fitting of the present invention without departing from the apparent scope thereof. The fixation ring can have material removed from the outer surface. The ringflange, locking ring, and combined fixation-locking ring can include holes on each side of the transecting slit for accepting a tied suture, similar mechanical latch, or contoured opposing interface surface providing for locking of the opposing faces and can be any other geometrical shape than circular such as hexagonal or octagonal.

Claims

WHAT IS CLAIMED IS:
1. Anastomotic fitting for connecting a vascular graft to a blood vessel comprising: a. means for positioning in a hole between an inner and outer wall of a blood vessel including an inflow orifice and an outflow orifice, said means including a lumen for supporting a vascular graft through said positioning means and everting back about said inflow orifice, and at least one indentation and groove disposed on each of said inflow and outflow ends of said positioning means respectively; b. means for engaging said overlapped vascular graft and locked into said indentation adjacent said inflow end and engaged against an inside wall about said hole of said blood vessel; e. means for affixing said positioning means including said engaging means and said vascular graft to an outside wall about said hole of said blood vessel; and, d. means for locking said affixation means to said positioning means and lockably engaged with said groove at said outflow orifice of said positioning means whereby said anastomotic fitting provides a surgical connection between said vascular graft to said blood vessel.
2. Anastomotic fitting of claim 1 wherein said positioning means comprises: tube including a short hollow right cylinder, a smooth internal surface, an inflow orifice at one end, a ringflange indentation disposed in an outer surface adjacent said inflow orifice, and at least one locking ring groove disposed in an outer surface adjacent an outflow orifice.
3. Anastomotic fitting of claim 2 wherein said number of locking ring grooves comprises five to ten.
4. Anastomotic fitting of claim 1 wherein said engaging means comprises: ringflange including a member including a concentric central aperture, pluralities of short and long spikes extending inwardly from an interior diameter, said short spikes engage said overlapped vascular graft and said long spikes engage through said vascular graft into said indentation at said outflow end.
5. Anastomotic fitting of- claim 4 comprising a slit through cross-section of said member whereby said slit facilitates engagement about said tube.
6. Anastomotic fitting of claim 1 wherein said affixing means comprises: member including a central aperture and pluralities of spikes extending outwardly from an angular face of said member whereby said central aperture engages with said positioning means and said pluralities of spikes engage against said blood vessel wall.
7. Anastomotic fitting of claim 1 wherein said locking means comprises: member including a central aperture and at least one locking ridge extending inwardly from an interior diameter of said member whereby said locking ring ridge engages against said groove disposed on said outflow end of said positioning means.
8. Anastomotic fitting of claim 7 wherein said number of locking ring ridges comprise one to three.
9. Anastomotic fitting of claim 7 comprising a slit through said cross-section of said member whereby said slit facilitates engagement about said positioning means.
10. Anastomotic fitting of claim 1 wherein said affixationmeans and said locking means comprises: a. integral member including member including a concentric central aperture, pluralities of spikes extending outwardly from an angular face of said member; and, b. at least one locking ridge extending inwardly from an interior diameter of said circular member whereby said central aperture engages with said positioning means, said pluralities of spikes engage against said blood vessel and said locking ring ridge engages against said groove disposed on said outflow end of positioning means.
11. Anastomotic fitting of claim 10 comprising a slit through cross-section of said integral member whereby said slit facilitates engagement about said positioning means.
12. Anastomotic fitting of claim 1 wherein said positioning means and said engaging means comprise: a. said positioning means further comprises a flared lip at said inflow orifice; b. said engaging means comprises a member including circular geometrical configured interior diameter including inversely rounded short spikes for engagement over said flared end and rounded long spikes for engagement in said indentation adjacent said inflow end.
13. Anastomotic fitting of claim 12 comprising a slit through cross-section of said circular geometrically configured member whereby said slit facilitates engagement about said positioning means.
14. Anastomotic fitting for coronary artery bypass surgery for connecting a vascular graft or reconnecting a vessel of a first diameter to a vessel of a second diameter, said anastomotic fitting comprising: a. cylindrieal tube including a lumen extending therethrough, a ringflange circumferential indentation adjacent an inflow end of said tube and plurality of locking ring grooves adjacent an outflow end of said tube; b. ringflange including a slitted member and a concentric central aperture therethrough, plurality of inwardly extending short and long spikes, said short spikes engaging said vascular graft at a plurality of points and said long spikes engaging through said vascular graft into said ringflange indentation, said ringflange engaged against an inside vessel wall; c. fixation ring including a truncated member and a concentric central aperture therethrough, pluralities of rows of outwardly extending spikes partially engaged into an outside vessel wall; and, d. locking ring including a member and a concentric central aperture therethrough and a plurality of inwardly extending locking ring ridges.
15. Anastomotic fitting for coronary artery bypass surgery for connecting a vascular graft or reconnecting a vessel of a first diameter to a vessel of a second diameter, said anastomotic fitting comprising: a. cylindrieal tube including a lumen extending therethrough, a ringflange circumferential indentation adjacent an inflow end of said tube and plurality of locking ring grooves adjacent an outflow end of said tube; b. ringflange including a slitted member and a concentric central aperture therethrough, plurality of inwardly extending short and long spikes, said short spikes engaging said vascular graft at a plurality of points and said long spikes engaging through said vascular graft into said ringflange indentation, and said ringflange engaged against an inside vessel wall; and, c. fixation ring-locking ring including a truncated member and a concentric central aperture therethrough, pluralities of rows of outwardly extending spikes partially engaged into an outside vessel wall, and a plurality of inwardly extending locking ring ridges.
PCT/US1981/001468 1980-11-17 1981-10-30 Anastomotic fitting WO1982001644A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU78910/81A AU7891081A (en) 1980-11-17 1981-10-30 Anastomotic fitting

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US207676801117 1980-11-17
US06/207,676 US4366819A (en) 1980-11-17 1980-11-17 Anastomotic fitting

Publications (1)

Publication Number Publication Date
WO1982001644A1 true WO1982001644A1 (en) 1982-05-27

Family

ID=22771544

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1981/001468 WO1982001644A1 (en) 1980-11-17 1981-10-30 Anastomotic fitting

Country Status (4)

Country Link
US (1) US4366819A (en)
EP (1) EP0064535A4 (en)
CA (1) CA1175726A (en)
WO (1) WO1982001644A1 (en)

Cited By (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2141346A (en) * 1983-06-15 1984-12-19 Mulas Piero Giovanni Mechanical valve for closing a cutaneous stoma
EP0129428A2 (en) * 1983-06-15 1984-12-27 Robert Roy Schenk Devices for joining anatomical structures
EP0158316A2 (en) * 1984-04-10 1985-10-16 Walsh Manufacturing (Mississauga) Limited Anastomosis devices and kit
US4607637A (en) * 1983-07-22 1986-08-26 Anders Berggren Surgical instrument for performing anastomosis with the aid of ring-like fastening elements and the fastening elements for performing anastomosis
US4624257A (en) * 1982-06-24 1986-11-25 Anders Berggren Surgical instrument for performing anastomosis
WO1988004539A1 (en) * 1986-12-18 1988-06-30 Unilink Inc. Instrument for prevention of constrictions in the joint area at the appliance of branching on vessel
FR2649605A1 (en) * 1989-07-13 1991-01-18 France Chirurgie Instr Corneal implant
US5036868A (en) * 1990-01-29 1991-08-06 Unilink Inc. Anastomosis preparation technique
EP0518856A1 (en) * 1990-03-06 1992-12-23 Univ New Mexico Everting forceps.
FR2685208A1 (en) * 1991-12-23 1993-06-25 Ela Medical Sa VENTRICULAR CANULATION DEVICE.
EP0548521A1 (en) * 1991-12-26 1993-06-30 American Cyanamid Company Anastomotic device
EP0593600A1 (en) * 1991-07-04 1994-04-27 OWEN, Earl Ronald Tubular surgical implant
US5500014A (en) * 1989-05-31 1996-03-19 Baxter International Inc. Biological valvular prothesis
WO1996009800A1 (en) * 1994-09-27 1996-04-04 Giliberti Umberto Cardiovascular graft
US5609626A (en) * 1989-05-31 1997-03-11 Baxter International Inc. Stent devices and support/restrictor assemblies for use in conjunction with prosthetic vascular grafts
WO1998040036A1 (en) * 1997-03-13 1998-09-17 United States Surgical Corporation Graft attachment assembly
US6808498B2 (en) 1998-02-13 2004-10-26 Ventrica, Inc. Placing a guide member into a heart chamber through a coronary vessel and delivering devices for placing the coronary vessel in communication with the heart chamber
WO2007117612A1 (en) * 2006-04-06 2007-10-18 Correx, Inc. Apparatus and method for suturelessly connecting a conduit to a hollow organ
US7510561B2 (en) 2004-03-23 2009-03-31 Correx, Inc. Apparatus and method for connecting a conduit to a hollow organ
EP1908420B1 (en) * 2006-10-06 2009-11-25 Ethicon Endo-Surgery, Inc. Anastomotic ring device with locking means
US7799041B2 (en) 2004-03-23 2010-09-21 Correx, Inc. Apparatus and method for forming a hole in a hollow organ
WO2012033847A1 (en) * 2010-09-07 2012-03-15 Spence Paul A Cannula systems and methods
US8277465B2 (en) 2004-12-15 2012-10-02 Correx, Inc. Apparatus and method for connecting a conduit to a hollow vessel
US8313013B2 (en) 2006-04-06 2012-11-20 Synovis Life Technologies, Inc. Method and assembly for anastomosis
US8414603B2 (en) 2007-09-25 2013-04-09 Correx, Inc. Applicator, assembly, and method for connecting an inlet conduit to a hollow organ
US9585991B2 (en) 2012-10-16 2017-03-07 Heartware, Inc. Devices, systems, and methods for facilitating flow from the heart to a blood pump
US9808283B2 (en) 2013-12-04 2017-11-07 Heartware, Inc. Apparatus and methods for cutting an atrial wall

Families Citing this family (344)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4474181A (en) * 1982-02-18 1984-10-02 Schenck Robert R Method and apparatus for anastomosing small blood vessels
US4624255A (en) * 1982-02-18 1986-11-25 Schenck Robert R Apparatus for anastomosing living vessels
US4523592A (en) * 1983-04-25 1985-06-18 Rollin K. Daniel P.S.C. Anastomotic coupling means capable of end-to-end and end-to-side anastomosis
US4787386A (en) * 1984-04-10 1988-11-29 Idea Research Investment Fund, Inc. Anastomosis devices, and kits
US4917087A (en) * 1984-04-10 1990-04-17 Walsh Manufacturing (Mississuaga) Limited Anastomosis devices, kits and method
US4593693A (en) * 1985-04-26 1986-06-10 Schenck Robert R Methods and apparatus for anastomosing living vessels
US4744793A (en) * 1985-09-06 1988-05-17 Zimmer, Inc. Prosthetic ligament connection assembly
US5405318A (en) * 1992-05-05 1995-04-11 Baxter International Inc. Ultra-sound catheter for removing obstructions from tubular anatomical structures such as blood vessels
US5324255A (en) * 1991-01-11 1994-06-28 Baxter International Inc. Angioplasty and ablative devices having onboard ultrasound components and devices and methods for utilizing ultrasound to treat or prevent vasopasm
US5267954A (en) * 1991-01-11 1993-12-07 Baxter International Inc. Ultra-sound catheter for removing obstructions from tubular anatomical structures such as blood vessels
US5957882A (en) * 1991-01-11 1999-09-28 Advanced Cardiovascular Systems, Inc. Ultrasound devices for ablating and removing obstructive matter from anatomical passageways and blood vessels
US5380274A (en) * 1991-01-11 1995-01-10 Baxter International Inc. Ultrasound transmission member having improved longitudinal transmission properties
US5304115A (en) * 1991-01-11 1994-04-19 Baxter International Inc. Ultrasonic angioplasty device incorporating improved transmission member and ablation probe
US5368558A (en) * 1991-01-11 1994-11-29 Baxter International Inc. Ultrasonic ablation catheter device having endoscopic component and method of using same
US5447509A (en) * 1991-01-11 1995-09-05 Baxter International Inc. Ultrasound catheter system having modulated output with feedback control
US5368557A (en) * 1991-01-11 1994-11-29 Baxter International Inc. Ultrasonic ablation catheter device having multiple ultrasound transmission members
US7033383B1 (en) 1991-07-03 2006-04-25 Cardiothoracic Systems, Inc. Endoscopic bypass grafting method utilizing an inguinal approach
US5304220A (en) * 1991-07-03 1994-04-19 Maginot Thomas J Method and apparatus for implanting a graft prosthesis in the body of a patient
US20060161173A1 (en) * 1991-07-03 2006-07-20 Maginot Thomas J Endoscopic bypass grafting method utilizing an inguinal approach
US7597697B1 (en) 1991-07-03 2009-10-06 Boston Scientific Scimed, Inc. Bypass grafting method
WO1993008750A2 (en) * 1991-11-04 1993-05-13 Baxter International Inc. Ultrasonic ablation device adapted for guidewire passage
US5382228A (en) * 1992-07-09 1995-01-17 Baxter International Inc. Method and device for connecting ultrasound transmission member (S) to an ultrasound generating device
US6494211B1 (en) 1993-02-22 2002-12-17 Hearport, Inc. Device and methods for port-access multivessel coronary artery bypass surgery
US5427118A (en) * 1993-10-04 1995-06-27 Baxter International Inc. Ultrasonic guidewire
US5417672A (en) * 1993-10-04 1995-05-23 Baxter International Inc. Connector for coupling an ultrasound transducer to an ultrasound catheter
US5390678A (en) * 1993-10-12 1995-02-21 Baxter International Inc. Method and device for measuring ultrasonic activity in an ultrasound delivery system
US5881943A (en) 1994-06-17 1999-03-16 Heartport, Inc. Surgical anastomosis apparatus and method thereof
US5732872A (en) 1994-06-17 1998-03-31 Heartport, Inc. Surgical stapling instrument
US5807243A (en) 1994-08-31 1998-09-15 Heartport, Inc. Method for isolating a surgical site
US6689086B1 (en) 1994-10-27 2004-02-10 Advanced Cardiovascular Systems, Inc. Method of using a catheter for delivery of ultrasonic energy and medicament
US6110187A (en) 1995-02-24 2000-08-29 Heartport, Inc. Device and method for minimizing heart displacements during a beating heart surgical procedure
US5904697A (en) * 1995-02-24 1999-05-18 Heartport, Inc. Devices and methods for performing a vascular anastomosis
US5976159A (en) 1995-02-24 1999-11-02 Heartport, Inc. Surgical clips and methods for tissue approximation
US5695504A (en) * 1995-02-24 1997-12-09 Heartport, Inc. Devices and methods for performing a vascular anastomosis
US5888247A (en) * 1995-04-10 1999-03-30 Cardiothoracic Systems, Inc Method for coronary artery bypass
US7445594B1 (en) 1995-09-20 2008-11-04 Medtronic, Inc. Method and apparatus for temporarily immobilizing a local area of tissue
US5836311A (en) * 1995-09-20 1998-11-17 Medtronic, Inc. Method and apparatus for temporarily immobilizing a local area of tissue
US6290644B1 (en) 1996-02-20 2001-09-18 Cardiothoracic Systems, Inc. Surgical instruments and procedures for stabilizing a localized portion of a beating heart
CA2197614C (en) 1996-02-20 2002-07-02 Charles S. Taylor Surgical instruments and procedures for stabilizing the beating heart during coronary artery bypass graft surgery
US5894843A (en) * 1996-02-20 1999-04-20 Cardiothoracic Systems, Inc. Surgical method for stabilizing the beating heart during coronary artery bypass graft surgery
US6852075B1 (en) * 1996-02-20 2005-02-08 Cardiothoracic Systems, Inc. Surgical devices for imposing a negative pressure to stabilize cardiac tissue during surgery
ES2236729T3 (en) * 1996-02-28 2005-07-16 Bard Peripheral Vascular Inc COLLARIN GRAFT FOR TERMINAL-LATERAL ANSTOMOSIS.
US6273912B1 (en) 1996-02-28 2001-08-14 Impra, Inc. Flanged graft for end-to-side anastomosis
SE509389C2 (en) * 1996-07-24 1999-01-18 Solem Jan Otto Device for connecting the end of a first blood vessel to the side of a second blood vessel
US6217585B1 (en) 1996-08-16 2001-04-17 Converge Medical, Inc. Mechanical stent and graft delivery system
US6293955B1 (en) 1996-09-20 2001-09-25 Converge Medical, Inc. Percutaneous bypass graft and securing system
US6036702A (en) * 1997-04-23 2000-03-14 Vascular Science Inc. Medical grafting connectors and fasteners
US6019788A (en) * 1996-11-08 2000-02-01 Gore Enterprise Holdings, Inc. Vascular shunt graft and junction for same
AU721415B2 (en) 1996-11-08 2000-07-06 Converge Medical, Inc. Percutaneous bypass graft and securing system
US5957879A (en) * 1997-01-24 1999-09-28 Heartport, Inc. Methods and devices for maintaining cardiopulmonary bypass and arresting a patient's heart
US6383134B1 (en) 1997-03-28 2002-05-07 Albert N. Santilli Surgical stabilizer having suction capability
US6458079B1 (en) * 1997-04-25 2002-10-01 Beth Israel Deaconess Medical Center Surgical retractor and method of use
US6033362A (en) * 1997-04-25 2000-03-07 Beth Israel Deaconess Medical Center Surgical retractor and method of use
US7235049B1 (en) * 1997-04-25 2007-06-26 Beth Israel Deaconess Medical Center Surgical retractor and method of positioning an artery during surgery
GB9709967D0 (en) * 1997-05-17 1997-07-09 Harris Peter L Prosthetic grafts
US6730103B2 (en) * 1997-05-19 2004-05-04 Pepi Dakov Connector system and methods for cutting and joining hollow anatomical structures
US6056762A (en) * 1997-05-22 2000-05-02 Kensey Nash Corporation Anastomosis system and method of use
US6063114A (en) * 1997-09-04 2000-05-16 Kensey Nash Corporation Connector system for vessels, ducts, lumens or hollow organs and methods of use
US6017352A (en) * 1997-09-04 2000-01-25 Kensey Nash Corporation Systems for intravascular procedures and methods of use
US5922022A (en) 1997-09-04 1999-07-13 Kensey Nash Corporation Bifurcated connector system for coronary bypass grafts and methods of use
US6969349B1 (en) * 1997-09-17 2005-11-29 Origin Medsystem, Inc. Device to permit offpump beating heart coronary bypass surgery
US6390976B1 (en) * 1997-09-17 2002-05-21 Origin Medsystems, Inc. System to permit offpump beating heart coronary bypass surgery
US6338712B2 (en) 1997-09-17 2002-01-15 Origin Medsystems, Inc. Device to permit offpump beating heart coronary bypass surgery
US6066144A (en) * 1997-10-07 2000-05-23 Ethicon Endo-Surgery, Inc. Surgical anastomosis method
US5993464A (en) 1998-01-23 1999-11-30 Ethicon Endo-Surgery, Inc. Surgical stapling instrument
NL1007349C2 (en) * 1997-10-24 1999-04-27 Suyker Wilhelmus Joseph Leonardus System for the mechanical production of anastomoses between hollow structures; as well as device and applicator for use therewith.
US6673039B1 (en) * 1997-12-19 2004-01-06 Trustees Of The University Of Pennsylvania Compositions, kits, methods, and apparatus for transvascular delivery of a composition to an extravascular tissue of a mammal
US6250305B1 (en) 1998-01-20 2001-06-26 Heartstent Corporation Method for using a flexible transmyocardial implant
US6193734B1 (en) * 1998-01-23 2001-02-27 Heartport, Inc. System for performing vascular anastomoses
US6007576A (en) * 1998-02-06 1999-12-28 Mcclellan; Scott B. End to side anastomic implant
US6651670B2 (en) * 1998-02-13 2003-11-25 Ventrica, Inc. Delivering a conduit into a heart wall to place a coronary vessel in communication with a heart chamber and removing tissue from the vessel or heart wall to facilitate such communication
US6352543B1 (en) * 2000-04-29 2002-03-05 Ventrica, Inc. Methods for forming anastomoses using magnetic force
US6280460B1 (en) * 1998-02-13 2001-08-28 Heartport, Inc. Devices and methods for performing vascular anastomosis
US20050192604A1 (en) * 1998-02-13 2005-09-01 Carson Dean F. Methods and devices for placing a conduit in fluid communication with a target vessel and a source of blood
US6015416A (en) 1998-02-26 2000-01-18 Ethicon Endo-Surgery, Inc. Surgical anastomosis instrument
US5951576A (en) * 1998-03-02 1999-09-14 Wakabayashi; Akio End-to-side vascular anastomosing stapling device
US6176864B1 (en) * 1998-03-09 2001-01-23 Corvascular, Inc. Anastomosis device and method
US6110188A (en) * 1998-03-09 2000-08-29 Corvascular, Inc. Anastomosis method
US6241741B1 (en) 1998-03-09 2001-06-05 Corvascular Surgical Systems, Inc. Anastomosis device and method
NL1009028C2 (en) * 1998-04-28 1999-10-29 Adri Marinus Blomme Adhesives for connecting a tubular vascular prosthesis to a blood vessel in the body as well as branching means, a vascular prosthesis, a device for inserting and adhering a vascular prosthesis and a vascular prosthesis system.
US7060084B1 (en) 1998-05-29 2006-06-13 By-Pass, Inc. Vascular closure device
US20040073247A1 (en) * 1998-05-29 2004-04-15 By-Pass, Inc. Method and apparatus for forming apertures in blood vessels
US20040049221A1 (en) * 1998-05-29 2004-03-11 By-Pass, Inc. Method and apparatus for forming apertures in blood vessels
AU4056499A (en) * 1998-05-29 1999-12-20 By-Pass, Ltd. Vascular port device
WO2000056228A1 (en) * 1999-03-19 2000-09-28 By-Pass, Inc. Low profile anastomosis connector
US20040087985A1 (en) * 1999-03-19 2004-05-06 Amir Loshakove Graft and connector delivery
US20050283188A1 (en) * 1998-05-29 2005-12-22 By-Pass, Inc. Vascular closure device
JP2002516696A (en) 1998-05-29 2002-06-11 バイ−パス・インク. Methods and devices for vascular surgery
US7063711B1 (en) 1998-05-29 2006-06-20 By-Pass, Inc. Vascular surgery
US6979338B1 (en) 1998-05-29 2005-12-27 By-Pass Inc. Low profile anastomosis connector
US6726704B1 (en) 1998-05-29 2004-04-27 By-Pass, Inc. Advanced closure device
US20050101983A1 (en) * 1998-05-29 2005-05-12 By-Pass,Inc. Method and apparatus for forming apertures in blood vessels
US6945980B2 (en) * 1998-06-03 2005-09-20 Medtronic, Inc. Multiple loop tissue connector apparatus and methods
US6641593B1 (en) 1998-06-03 2003-11-04 Coalescent Surgical, Inc. Tissue connector apparatus and methods
US6613059B2 (en) * 1999-03-01 2003-09-02 Coalescent Surgical, Inc. Tissue connector apparatus and methods
US6607541B1 (en) * 1998-06-03 2003-08-19 Coalescent Surgical, Inc. Tissue connector apparatus and methods
WO2000015144A1 (en) 1998-06-10 2000-03-23 Advanced Bypass Technologies, Inc. Aortic aneurysm treatment systems
US6461320B1 (en) * 1998-08-12 2002-10-08 Cardica, Inc. Method and system for attaching a graft to a blood vessel
US6206913B1 (en) 1998-08-12 2001-03-27 Vascular Innovations, Inc. Method and system for attaching a graft to a blood vessel
US6210365B1 (en) 1998-08-14 2001-04-03 Cardiovention, Inc. Perfusion catheter system having sutureless arteriotomy seal and methods of use
BR9913759A (en) * 1998-09-15 2001-06-12 Medtronic Inc System to temporarily immobilize an area of tissue, and system to stabilize tissue
US7018387B2 (en) * 1998-10-22 2006-03-28 Innovative Interventional Technologies B.V. Mechanical anastomosis system for hollow structures
US6475222B1 (en) * 1998-11-06 2002-11-05 St. Jude Medical Atg, Inc. Minimally invasive revascularization apparatus and methods
US6146393A (en) * 1998-12-18 2000-11-14 Wakabayashi; Akio External tubular stapling device for anastomosing a vascular graft to an anastomosing sheath
US8118822B2 (en) 1999-03-01 2012-02-21 Medtronic, Inc. Bridge clip tissue connector apparatus and methods
US6695859B1 (en) * 1999-04-05 2004-02-24 Coalescent Surgical, Inc. Apparatus and methods for anastomosis
US6726694B2 (en) 1999-04-16 2004-04-27 Integrated Vascular Interventional Technologies, L.C. (Ivit, Lc) Intraluminally directed anvil apparatus and related methods and systems
US6743244B2 (en) 1999-04-16 2004-06-01 Integrated Vascular Interventional Technologies, L.C. Soft anvil apparatus for cutting anastomosis fenestra
US6248117B1 (en) 1999-04-16 2001-06-19 Vital Access Corp Anastomosis apparatus for use in intraluminally directed vascular anastomosis
US6652542B2 (en) 1999-04-16 2003-11-25 Integrated Vascular Interventional Technologies, L.C. (Ivit, Lc) External anastomosis operators and related systems for anastomosis
US7981126B2 (en) * 1999-04-16 2011-07-19 Vital Access Corporation Locking compression plate anastomosis apparatus
US7160311B2 (en) * 1999-04-16 2007-01-09 Integrated Vascular Interventional Technologies, L.C. (Ivit Lc) Locking compression plate anastomosis apparatus
US6551334B2 (en) 1999-04-16 2003-04-22 Integrated Vascular Interventional Technologies, Lc Externally directed anastomosis systems and externally positioned anastomosis fenestra cutting apparatus
US6623494B1 (en) * 1999-04-16 2003-09-23 Integrated Vascular Interventional Technologies, L.C. (Ivit, Lc) Methods and systems for intraluminally directed vascular anastomosis
US6569173B1 (en) 1999-12-14 2003-05-27 Integrated Vascular Interventional Technologies, L.C. Compression plate anastomosis apparatus
US6626830B1 (en) 1999-05-04 2003-09-30 Cardiothoracic Systems, Inc. Methods and devices for improved tissue stabilization
US6685632B1 (en) * 1999-05-04 2004-02-03 Cardiothoracic Systems, Inc. Surgical instruments for accessing and stabilizing a localized portion of a beating heart
US6231506B1 (en) 1999-05-04 2001-05-15 Cardiothoracic Systems, Inc. Method and apparatus for creating a working opening through an incision
US6283912B1 (en) * 1999-05-04 2001-09-04 Cardiothoracic Systems, Inc. Surgical retractor platform blade apparatus
US6673088B1 (en) 1999-05-18 2004-01-06 Cardica, Inc. Tissue punch
US6428550B1 (en) * 1999-05-18 2002-08-06 Cardica, Inc. Sutureless closure and deployment system for connecting blood vessels
US7048751B2 (en) * 2001-12-06 2006-05-23 Cardica, Inc. Implantable medical device such as an anastomosis device
US6719769B2 (en) 1999-11-15 2004-04-13 Cardica, Inc. Integrated anastomosis tool with graft vessel attachment device and cutting device
AU5150600A (en) * 1999-05-18 2000-12-05 Vascular Innovations, Inc. Tissue punch
WO2000069364A2 (en) 1999-05-18 2000-11-23 Vascular Innovations, Inc. Implantable medical device such as an anastomosis device
US6179849B1 (en) * 1999-06-10 2001-01-30 Vascular Innovations, Inc. Sutureless closure for connecting a bypass graft to a target vessel
US6258023B1 (en) * 1999-07-08 2001-07-10 Chase Medical, Inc. Device and method for isolating a surface of a beating heart during surgery
US7300444B1 (en) * 1999-07-28 2007-11-27 Cardica, Inc. Surgical system and method for connecting hollow tissue structures
US20050154406A1 (en) * 1999-07-28 2005-07-14 Cardica, Inc. Method for anastomosing vessels
US6391038B2 (en) * 1999-07-28 2002-05-21 Cardica, Inc. Anastomosis system and method for controlling a tissue site
US7766924B1 (en) 1999-07-28 2010-08-03 Cardica, Inc. System for performing anastomosis
US7063712B2 (en) * 2001-04-27 2006-06-20 Cardica, Inc. Anastomosis method
US7892246B2 (en) 1999-07-28 2011-02-22 Bioconnect Systems, Inc. Devices and methods for interconnecting conduits and closing openings in tissue
US7371243B1 (en) 1999-07-28 2008-05-13 Cardica, Inc. Surgical apparatus and method for anastomosis
US7285131B1 (en) * 1999-07-28 2007-10-23 Cardica, Inc. System for performing anastomosis
US7850703B2 (en) * 1999-07-28 2010-12-14 Cardica, Inc. System for performing anastomosis
US7014644B1 (en) 1999-07-28 2006-03-21 Cardica, Inc. Tissue bonding system and method for controlling a tissue site during anastomosis
US7682368B1 (en) 1999-07-28 2010-03-23 Cardica, Inc. Anastomosis tool actuated with stored energy
US6511416B1 (en) * 1999-08-03 2003-01-28 Cardiothoracic Systems, Inc. Tissue stabilizer and methods of use
US6253768B1 (en) * 1999-08-04 2001-07-03 Percardia, Inc. Vascular graft bypass
US20020173809A1 (en) * 1999-09-01 2002-11-21 Fleischman Sidney D. Sutureless anastomosis system deployment concepts
US6702828B2 (en) * 1999-09-01 2004-03-09 Converge Medical, Inc. Anastomosis system
US6494889B1 (en) 1999-09-01 2002-12-17 Converge Medical, Inc. Additional sutureless anastomosis embodiments
US8529583B1 (en) 1999-09-03 2013-09-10 Medtronic, Inc. Surgical clip removal apparatus
US6406424B1 (en) * 1999-09-16 2002-06-18 Williamson, Iv Warren P. Tissue stabilizer having an articulating lift element
US6926730B1 (en) * 2000-10-10 2005-08-09 Medtronic, Inc. Minimally invasive valve repair procedure and apparatus
US6682540B1 (en) 1999-11-05 2004-01-27 Onux Medical, Inc. Apparatus and method for placing multiple sutures
US6402764B1 (en) 1999-11-15 2002-06-11 Cardica, Inc. Everter and threadthrough system for attaching graft vessel to anastomosis device
US20030130671A1 (en) * 1999-11-23 2003-07-10 Duhaylongsod Francis G. Anastomosis device and method
US20040068278A1 (en) * 1999-12-06 2004-04-08 Converge Medical Inc. Anastomosis systems
US6736825B2 (en) 1999-12-14 2004-05-18 Integrated Vascular Interventional Technologies, L C (Ivit Lc) Paired expandable anastomosis devices and related methods
US7131959B2 (en) * 2003-01-23 2006-11-07 Integrated Vascular Interventional Technologies, L.C., (“IVIT LC”) Apparatus and methods for occluding an access tube anastomosed to sidewall of an anatomical vessel
US7338434B1 (en) 2002-08-21 2008-03-04 Medtronic, Inc. Method and system for organ positioning and stabilization
AU2001228774A1 (en) * 2000-03-20 2001-10-03 By-Pass, Inc. Graft delivery system
BRPI9706197C2 (en) * 2000-03-20 2006-07-18 Thomas & Cantareli Negocios E anastomosis prosthesis
CA2403289A1 (en) * 2000-03-20 2001-09-27 By-Pass, Inc. Graft and connector delivery
US6551332B1 (en) * 2000-03-31 2003-04-22 Coalescent Surgical, Inc. Multiple bias surgical fastener
US7232449B2 (en) * 2000-04-29 2007-06-19 Medtronic, Inc. Components, systems and methods for forming anastomoses using magnetism or other coupling means
US20050080439A1 (en) * 2000-04-29 2005-04-14 Carson Dean F. Devices and methods for forming magnetic anastomoses and ports in vessels
US8518062B2 (en) 2000-04-29 2013-08-27 Medtronic, Inc. Devices and methods for forming magnetic anastomoses between vessels
US7241300B2 (en) * 2000-04-29 2007-07-10 Medtronic, Inc, Components, systems and methods for forming anastomoses using magnetism or other coupling means
AU2000258814A1 (en) 2000-06-20 2002-01-02 Chf Solutions, Inc. Anastomosis device and method
US6530932B1 (en) 2000-08-30 2003-03-11 Ethicon Endo-Surgery, Inc. Anastomosis device having improved tissue presentation
US6520973B1 (en) 2000-08-30 2003-02-18 Ethicon Endo-Surgery, Inc. Anastomosis device having an improved needle driver
US6613058B1 (en) 2000-08-30 2003-09-02 Ethicon Endo-Surgery, Inc. Anastomosis device having needle receiver for capturing the needle
US6514263B1 (en) 2000-08-30 2003-02-04 Ethicon Endo-Surgery, Inc. Helical needle and suture combination having a strain relief element
WO2002017771A2 (en) 2000-09-01 2002-03-07 Advanced Vascular Technologies, Llc Multi-fastener surgical apparatus and method
WO2002017796A1 (en) * 2000-09-01 2002-03-07 Advanced Vascular Technologies, Llc Vascular bypass grafting instrument and method
CA2441866A1 (en) * 2000-09-01 2002-09-07 Onux Medical, Inc. Endovascular fastener and grafting apparatus and method
US7261735B2 (en) * 2001-05-07 2007-08-28 Cordis Corporation Local drug delivery devices and methods for maintaining the drug coatings thereon
ATE343969T1 (en) * 2000-09-29 2006-11-15 Cordis Corp COATED MEDICAL DEVICES
US20060222756A1 (en) * 2000-09-29 2006-10-05 Cordis Corporation Medical devices, drug coatings and methods of maintaining the drug coatings thereon
US6776785B1 (en) * 2000-10-12 2004-08-17 Cardica, Inc. Implantable superelastic anastomosis device
US6746459B2 (en) 2000-10-19 2004-06-08 Terumo Kabushiki Kaisha End-to-side blood vessel anastomosis method and instruments therefor
US20050234483A1 (en) * 2000-11-06 2005-10-20 Cardica, Inc. Unitary anastomosis device
US6966917B1 (en) * 2000-11-09 2005-11-22 Innovation Interventional Technologies B.V. Deformable connector for mechanically connecting hollow structures
US6471713B1 (en) 2000-11-13 2002-10-29 Cardica, Inc. System for deploying an anastomosis device and method of performing anastomosis
US6554764B1 (en) 2000-11-13 2003-04-29 Cardica, Inc. Graft vessel preparation device and methods for using the same
US20020143347A1 (en) * 2000-12-13 2002-10-03 Ventrica, Inc. Extravascular anastomotic components and methods for forming vascular anastomoses
US7909837B2 (en) * 2000-12-13 2011-03-22 Medtronic, Inc. Methods, devices and systems for forming magnetic anastomoses
US6676597B2 (en) 2001-01-13 2004-01-13 Medtronic, Inc. Method and device for organ positioning
US20020095166A1 (en) * 2001-01-16 2002-07-18 Jaime Vargas Incision tensioning system and method for using the same
US6758808B2 (en) 2001-01-24 2004-07-06 Cardiothoracic System, Inc. Surgical instruments for stabilizing a localized portion of a beating heart
WO2002069813A2 (en) 2001-02-05 2002-09-12 A-Med Systems, Inc. Anastomosis system and related methods
US6890338B1 (en) * 2001-02-27 2005-05-10 Origin Medsystems, Inc. Method and apparatus for performing anastomosis using ring having tines with weak sections
US20060293701A1 (en) * 2001-05-02 2006-12-28 Medtronic, Inc. Self-closing surgical clip for tissue
US8182527B2 (en) 2001-05-07 2012-05-22 Cordis Corporation Heparin barrier coating for controlled drug release
KR20020091523A (en) * 2001-05-31 2002-12-06 (주)에이치비메디컬스 Vascular anastomosis device
KR20020094075A (en) * 2001-06-07 2002-12-18 (주)에이치비메디컬스 Vascular anastomosis device
US6626920B2 (en) * 2001-07-05 2003-09-30 Converge Medical, Inc. Distal anastomosis system
US20030229365A1 (en) * 2002-06-10 2003-12-11 Whayne James G. Angled vascular anastomosis system
US6972023B2 (en) * 2001-07-05 2005-12-06 Converge Medical, Inc. Distal anastomosis system
US6858035B2 (en) 2001-07-05 2005-02-22 Converge Medical, Inc. Distal anastomosis system
US20060064119A9 (en) * 2001-07-05 2006-03-23 Converge Medical, Inc. Vascular anastomosis systems
US7195640B2 (en) * 2001-09-25 2007-03-27 Cordis Corporation Coated medical devices for the treatment of vulnerable plaque
US20030065345A1 (en) * 2001-09-28 2003-04-03 Kevin Weadock Anastomosis devices and methods for treating anastomotic sites
US6605098B2 (en) 2001-09-28 2003-08-12 Ethicon, Inc. Surgical device for creating an anastomosis between first and second hollow organs
US7892247B2 (en) * 2001-10-03 2011-02-22 Bioconnect Systems, Inc. Devices and methods for interconnecting vessels
US6942672B2 (en) 2001-10-23 2005-09-13 Vascor, Inc. Method and apparatus for attaching a conduit to the heart or a blood vessel
US8012164B1 (en) 2002-01-22 2011-09-06 Cardica, Inc. Method and apparatus for creating an opening in the wall of a tubular vessel
US7029482B1 (en) 2002-01-22 2006-04-18 Cardica, Inc. Integrated anastomosis system
US7335216B2 (en) * 2002-01-22 2008-02-26 Cardica, Inc. Tool for creating an opening in tissue
US7223274B2 (en) * 2002-01-23 2007-05-29 Cardica, Inc. Method of performing anastomosis
US7427261B1 (en) 2002-01-23 2008-09-23 Cardica, Inc. System for preparing a craft vessel for anastomosis
US6821286B1 (en) * 2002-01-23 2004-11-23 Cardica, Inc. System for preparing a graft vessel for anastomosis
DE10205997A1 (en) * 2002-02-14 2003-09-04 Hm Medical Engineering Gmbh Joint element, in particular suitable for connecting vessel or nerve sections, enveloped by barbed sleeve
WO2003086206A1 (en) * 2002-04-11 2003-10-23 Tyco Healthcare Group, Lp Surgical stapling apparatus including an anvil and cartridge each having cooperating mating surfaces
US20030199974A1 (en) * 2002-04-18 2003-10-23 Coalescent Surgical, Inc. Annuloplasty apparatus and methods
US20030204168A1 (en) * 2002-04-30 2003-10-30 Gjalt Bosma Coated vascular devices
US20050267498A1 (en) * 2002-04-30 2005-12-01 Cardica, Inc. Tissue everting device and method
US20050228442A1 (en) * 2002-05-06 2005-10-13 Wheatley Margaret A Tissue joining devices capable of delivery of bioactive agents and methods for use thereof
US20070083258A1 (en) 2005-10-06 2007-04-12 Robert Falotico Intraluminal device and therapeutic agent combination for treating aneurysmal disease
US8083804B2 (en) 2002-06-19 2011-12-27 Tyco Healthcare Group Lp Method and apparatus for anastomosis including annular joining member
US7155273B2 (en) * 2002-07-29 2006-12-26 Taylor Geoffrey L Blanching response pressure sore detector apparatus and method
US6969395B2 (en) * 2002-08-07 2005-11-29 Boston Scientific Scimed, Inc. Electroactive polymer actuated medical devices
US7494460B2 (en) * 2002-08-21 2009-02-24 Medtronic, Inc. Methods and apparatus providing suction-assisted tissue engagement through a minimally invasive incision
US8066724B2 (en) 2002-09-12 2011-11-29 Medtronic, Inc. Anastomosis apparatus and methods
US6896688B2 (en) * 2002-09-12 2005-05-24 Edrich Health Technologies, Inc. Prosthetic vascular graft connector
US20060025788A1 (en) * 2002-09-25 2006-02-02 By-Pass, Inc. Anastomotic leg arrangement
US8105345B2 (en) * 2002-10-04 2012-01-31 Medtronic, Inc. Anastomosis apparatus and methods
US7931590B2 (en) 2002-10-29 2011-04-26 Maquet Cardiovascular Llc Tissue stabilizer and methods of using the same
US7591827B2 (en) * 2002-11-19 2009-09-22 J. Donald Hill Conduit coupling devices and methods for employing such devices
DE60334313D1 (en) * 2002-11-19 2010-11-04 J Donald Hill SYSTEM AND DEVICE FOR CARRYING OUT MINIMAL INVASIVE CORONARY ARTERY BYPASS IMPLANTATION
US8377082B2 (en) * 2003-01-14 2013-02-19 Medtronic, Inc. Methods and apparatus for making precise incisions in body vessels
US20040236178A1 (en) * 2003-02-14 2004-11-25 Cardica, Inc. Method for preparing a graft vessel for anastomosis
US20040167572A1 (en) * 2003-02-20 2004-08-26 Roth Noah M. Coated medical devices
US20050075659A1 (en) * 2003-03-30 2005-04-07 Fidel Realyvasquez Apparatus and methods for minimally invasive valve surgery
US7527632B2 (en) * 2003-03-31 2009-05-05 Cordis Corporation Modified delivery device for coated medical devices
CA2426378C (en) * 2003-04-30 2012-03-13 Sawquip International Inc. Log positioning and conveying apparatus
US20040236416A1 (en) * 2003-05-20 2004-11-25 Robert Falotico Increased biocompatibility of implantable medical devices
US7794471B1 (en) 2003-06-26 2010-09-14 Cardica, Inc. Compliant anastomosis system
US8574246B1 (en) 2004-06-25 2013-11-05 Cardica, Inc. Compliant anastomosis system utilizing suture
US7479104B2 (en) 2003-07-08 2009-01-20 Maquet Cardiovascular, Llc Organ manipulator apparatus
US7182769B2 (en) * 2003-07-25 2007-02-27 Medtronic, Inc. Sealing clip, delivery systems, and methods
US20050033417A1 (en) * 2003-07-31 2005-02-10 John Borges Coating for controlled release of a therapeutic agent
US20050043749A1 (en) * 2003-08-22 2005-02-24 Coalescent Surgical, Inc. Eversion apparatus and methods
US6965203B2 (en) * 2003-09-17 2005-11-15 Synaptic Tan, Inc. Method and circuit for repetitively firing a flash lamp or the like
US8394114B2 (en) * 2003-09-26 2013-03-12 Medtronic, Inc. Surgical connection apparatus and methods
US20050262673A1 (en) * 2003-10-09 2005-12-01 Strahm Textile Systems Ag Device for removing needles from a fabric web
US7879047B2 (en) 2003-12-10 2011-02-01 Medtronic, Inc. Surgical connection apparatus and methods
US20050137677A1 (en) * 2003-12-17 2005-06-23 Rush Scott L. Endovascular graft with differentiable porosity along its length
US20050149073A1 (en) * 2003-12-17 2005-07-07 Arani Djavad T. Mechanisms and methods used in the anastomosis of biological conduits
US8747881B2 (en) * 2003-12-19 2014-06-10 Cordis Corporation Intraluminal medical devices in combination with therapeutic agents
US20050249776A1 (en) * 2003-12-19 2005-11-10 Chen Chao C Coated aneurysmal repair device
US8652502B2 (en) * 2003-12-19 2014-02-18 Cordis Corporation Local vascular delivery of trichostatin A alone or in combination with sirolimus to prevent restenosis following vascular injury
ITBO20030782A1 (en) * 2003-12-23 2005-06-24 New Age Const And Engineeri Ng S P A DEVICE AND METHOD FOR ANASTOMOSIS.
US7585306B2 (en) * 2003-12-24 2009-09-08 Maquet Cardiovascular Llc Anastomosis device, tools and methods of using
US20050149071A1 (en) * 2003-12-24 2005-07-07 Ryan Abbott Anastomosis device, tools and method of using
US20080269784A1 (en) * 2003-12-24 2008-10-30 Ryan Abbott Anastomosis device, tools and methods of using
US20050148824A1 (en) * 2003-12-30 2005-07-07 Morejohn Dwight P. Transabdominal surgery system
US7179224B2 (en) * 2003-12-30 2007-02-20 Cardiothoracic Systems, Inc. Organ manipulator and positioner and methods of using the same
US7303758B2 (en) 2004-01-20 2007-12-04 Cordis Corporation Local vascular delivery of mycophenolic acid in combination with rapamycin to prevent restenosis following vascular injury
US7806924B2 (en) * 2004-02-18 2010-10-05 Cordis Corporation Implantable structures for local vascular delivery of cladribine in combination with rapamycin for restenosis
US20050187608A1 (en) * 2004-02-24 2005-08-25 O'hara Michael D. Radioprotective compound coating for medical devices
US8828416B2 (en) 2004-03-09 2014-09-09 Cordis Corporation Local vascular delivery of topotecan in combination with rapamycin to prevent restenosis following vascular injury
US7875282B2 (en) * 2004-03-22 2011-01-25 Cordis Corporation Coated medical device for local vascular delivery of Panzem® in combination with rapamycin to prevent restenosis following vascular injury
US7695731B2 (en) 2004-03-22 2010-04-13 Cordis Corporation Local vascular delivery of etoposide in combination with rapamycin to prevent restenosis following vascular injury
US7399272B2 (en) 2004-03-24 2008-07-15 Medtronic, Inc. Methods and apparatus providing suction-assisted tissue engagement
US8003122B2 (en) * 2004-03-31 2011-08-23 Cordis Corporation Device for local and/or regional delivery employing liquid formulations of therapeutic agents
US7989490B2 (en) * 2004-06-02 2011-08-02 Cordis Corporation Injectable formulations of taxanes for cad treatment
US7846940B2 (en) * 2004-03-31 2010-12-07 Cordis Corporation Solution formulations of sirolimus and its analogs for CAD treatment
US8007737B2 (en) 2004-04-14 2011-08-30 Wyeth Use of antioxidants to prevent oxidation and reduce drug degradation in drug eluting medical devices
US20050232965A1 (en) * 2004-04-15 2005-10-20 Robert Falotico Local administration of a combination of rapamycin and 17 beta-estradiol for the treatment of vulnerable plaque
US20050267559A1 (en) * 2004-05-11 2005-12-01 De Oliveira Daniel D Cuffed grafts for vascular anastomosis
US20060004394A1 (en) * 2004-05-13 2006-01-05 Amarant Paul D Double-ended conduit with graded locking sleeves
US8162963B2 (en) * 2004-06-17 2012-04-24 Maquet Cardiovascular Llc Angled anastomosis device, tools and method of using
US9138228B2 (en) 2004-08-11 2015-09-22 Emory University Vascular conduit device and system for implanting
US7515970B2 (en) * 2004-08-18 2009-04-07 Cardiac Pacemakers, Inc. Transeptal lead
ITMI20042131A1 (en) * 2004-11-05 2005-02-05 Ethicon Endo Surgery Inc DEVICE AND METHOD FOR OBESITY THERAPY
US20060129225A1 (en) * 2004-12-15 2006-06-15 Kopia Gregory A Device for the delivery of a cardioprotective agent to ischemic reperfused myocardium
US20070088203A1 (en) * 2005-05-25 2007-04-19 Liming Lau Surgical assemblies and methods for visualizing and performing surgical procedures in reduced-access surgical sites
US8083664B2 (en) 2005-05-25 2011-12-27 Maquet Cardiovascular Llc Surgical stabilizers and methods for use in reduced-access surgical sites
US8709069B2 (en) 2005-07-01 2014-04-29 C. R. Bard, Inc. Flanged graft with trim lines
US20070026042A1 (en) * 2005-07-29 2007-02-01 Narayanan Pallasssana V System for treating aneurysmal disease
US20070048350A1 (en) 2005-08-31 2007-03-01 Robert Falotico Antithrombotic coating for drug eluting medical devices
US8784860B2 (en) * 2005-10-27 2014-07-22 Cordis Corporation Local administration of a combination of rapamycin and cilostazol for the treatment of vascular disease
US20070173787A1 (en) * 2005-11-01 2007-07-26 Huang Mark C T Thin-film nitinol based drug eluting stent
US20070116736A1 (en) * 2005-11-23 2007-05-24 Argentieri Dennis C Local vascular delivery of PI3 kinase inhibitors alone or in combination with sirolimus to prevent restinosis following vascular injury
JP4855483B2 (en) * 2006-01-12 2012-01-18 プロゼオ バスキュラー インプラント アーベー Equipment for anastomosis
ITMI20060410A1 (en) * 2006-03-07 2007-09-08 Ethicon Endo Surgery Inc ANASTOMOTIC DEVICE
US8828074B2 (en) * 2006-04-21 2014-09-09 Medtronic Vascular, Inc. Stent graft having short tube graft for branch vessel
US7794387B2 (en) 2006-04-26 2010-09-14 Medtronic, Inc. Methods and devices for stabilizing tissue
BRPI0603437A2 (en) * 2006-06-06 2010-07-06 Luiz Gonzaga Granja Jr extraluminal stent anastomosis prosthesis
BRPI0602381A (en) * 2006-06-06 2008-01-22 Luiz Gonzaga Granja Jr anastomosis prosthesis
BRPI0602382A (en) * 2006-06-06 2008-01-22 Luiz Gonzaga Granja Jr anastomosis prosthesis
BRPI0602378A (en) * 2006-06-06 2008-01-22 Luiz Gonzaga Granja Jr flanged anastomosis prosthesis
BRPI0602379A (en) * 2006-06-06 2008-01-22 Luiz Gonzaga Granja Jr anastomosis prosthesis
BRPI0602736A (en) * 2006-06-06 2008-01-29 Luiz Gonzaga Granja Jr inflatable anastomosis prosthesis
BRPI0602385A (en) * 2006-06-06 2008-01-29 Luiz Gonzaga Granja Jr snap-on prosthesis and anastomotic prosthesis tray
BRPI0602735A (en) * 2006-06-06 2008-01-29 Luiz Gonzaga Granja Jr anastomosis prosthesis
BRPI0603438A (en) * 2006-06-06 2008-02-12 Luiz Gonzaga Granja Jr laparoscopic anastomosis prosthesis
BRPI0602380A (en) * 2006-06-06 2008-01-22 Luiz Gonzaga Granja Jr anastomosis prosthesis
US20100114129A1 (en) * 2006-07-20 2010-05-06 Wheatley Margaret A Tissue joining devices capable of delivery of bioactive agents and methods of use thereof
US8506984B2 (en) * 2006-07-26 2013-08-13 Cordis Corporation Therapeutic agent elution control process
EP2120732A2 (en) * 2007-01-05 2009-11-25 Medtronic, Inc. Anastomosis systems and methods
US20080241215A1 (en) * 2007-03-28 2008-10-02 Robert Falotico Local vascular delivery of probucol alone or in combination with sirolimus to treat restenosis, vulnerable plaque, aaa and stroke
US7846123B2 (en) * 2007-04-24 2010-12-07 Emory University Conduit device and system for implanting a conduit device in a tissue wall
US9282967B2 (en) 2007-08-02 2016-03-15 Bioconnect Systems, Inc. Implantable flow connector
EP2173276A4 (en) * 2007-08-02 2015-07-08 Bio Connect Systems Implantable flow connector
US7988026B2 (en) 2007-09-06 2011-08-02 Cardica, Inc. Endocutter with staple feed
US9168039B1 (en) 2007-09-06 2015-10-27 Cardica, Inc. Surgical stapler with staples of different sizes
US8070036B1 (en) 2007-09-06 2011-12-06 Cardica, Inc True multi-fire surgical stapler configured to fire staples of different sizes
US20090074831A1 (en) * 2007-09-18 2009-03-19 Robert Falotico LOCAL VASCULAR DELIVERY OF mTOR INHIBITORS IN COMBINATION WITH PEROXISOME PROLIFERATORS-ACTIVATED RECEPTOR STIMULATORS
EP2231068A1 (en) * 2007-12-27 2010-09-29 C.R. Bard, Inc. Vascular graft prosthesis having a reinforced margin for enhanced anastomosis
US9603980B2 (en) 2008-02-26 2017-03-28 CARDINAL HEALTH SWITZERLAND 515 GmbH Layer-by-layer stereocomplexed polymers as drug depot carriers or coatings in medical devices
US20110295181A1 (en) 2008-03-05 2011-12-01 Hemosphere, Inc. Implantable and removable customizable body conduit
US8177836B2 (en) * 2008-03-10 2012-05-15 Medtronic, Inc. Apparatus and methods for minimally invasive valve repair
US8420110B2 (en) * 2008-03-31 2013-04-16 Cordis Corporation Drug coated expandable devices
US8409601B2 (en) 2008-03-31 2013-04-02 Cordis Corporation Rapamycin coated expandable devices
US8273404B2 (en) * 2008-05-19 2012-09-25 Cordis Corporation Extraction of solvents from drug containing polymer reservoirs
SE533398C2 (en) * 2008-11-21 2010-09-14 Hassan Kansoul Anastomotic medical device
US8905961B2 (en) * 2008-12-19 2014-12-09 St. Jude Medical, Inc. Systems, apparatuses, and methods for cardiovascular conduits and connectors
US8518060B2 (en) * 2009-04-09 2013-08-27 Medtronic, Inc. Medical clip with radial tines, system and method of using same
US8668704B2 (en) * 2009-04-24 2014-03-11 Medtronic, Inc. Medical clip with tines, system and method of using same
US8167898B1 (en) 2009-05-05 2012-05-01 Cardica, Inc. Flexible cutter for surgical stapler
US20140155804A1 (en) * 2009-07-07 2014-06-05 Marwan Tabbara Surgical devices and kits
US8591451B2 (en) * 2009-07-07 2013-11-26 Marwan Tabbara Surgical methods, devices, and kits
US20110118764A1 (en) * 2009-08-14 2011-05-19 Beane Richard M Method and apparatus for effecting a minimally invasive distal anastomosis for an aortic valve bypass
US9022998B2 (en) 2010-02-26 2015-05-05 Maquet Cardiovascular Llc Blower instrument, apparatus and methods of using
US9642623B2 (en) 2010-04-16 2017-05-09 The University Of Utah Research Foundation Methods, devices and apparatus for performing a vascular anastomosis
AU2011268433A1 (en) 2010-06-14 2013-01-10 Maquet Cardiovascular Llc Surgical instruments, systems and methods of use
TW201225997A (en) * 2010-08-20 2012-07-01 Thoratec Corp Assembly and method for stabilizing a percutaneous cable
CA2824936A1 (en) 2011-01-28 2012-08-02 Apica Cardiovascular Limited Systems for sealing a tissue wall puncture
WO2012106422A2 (en) 2011-02-01 2012-08-09 Georgia Tech Research Corporation Systems for implanting and using a conduit within a tissue wall
WO2013036643A2 (en) 2011-09-06 2013-03-14 Hemosphere, Inc. Vascular access system with connector
US9314600B2 (en) 2012-04-15 2016-04-19 Bioconnect Systems, Inc. Delivery system for implantable flow connector
US10434293B2 (en) * 2012-04-15 2019-10-08 Tva Medical, Inc. Implantable flow connector
US9381101B2 (en) 2012-04-23 2016-07-05 The Charlotte-Mecklenburg Hospital Authority Hybrid graft for therapy of aortic pathology and associated method
JP6132484B2 (en) * 2012-06-21 2017-05-24 オリンパス株式会社 Access port
DE102012107919A1 (en) * 2012-08-28 2014-05-15 Aesculap Ag Electrosurgical instrument for making an end-to-end anastomosis
EP2948104B1 (en) 2013-01-25 2019-07-24 Apica Cardiovascular Limited Systems for percutaneous access, stabilization and closure of organs
JP6302992B2 (en) 2013-03-15 2018-03-28 エーピーケー アドバンスド メディカル テクノロジーズ,インコーポレイテッド Connector for implantation into the tissue wall
US11051818B2 (en) 2013-08-21 2021-07-06 King Faisal Specialist Hospital And Research Center Device for connecting hollow organs, especially blood vessels, by surgery
WO2015094514A1 (en) 2013-12-20 2015-06-25 Cryolife, Inc. Vascular access system with reinforcement member
US10485909B2 (en) 2014-10-31 2019-11-26 Thoratec Corporation Apical connectors and instruments for use in a heart wall
US10675034B2 (en) 2015-04-13 2020-06-09 Innovative Interventional Technologies, B.V. Anastomosis device for making anastomoses between hollow structures
EP3202338A1 (en) * 2016-02-05 2017-08-09 CHU de Nice Anastomotic connector
US11383072B2 (en) * 2017-01-12 2022-07-12 Merit Medical Systems, Inc. Methods and systems for selection and use of connectors between conduits
WO2018140306A1 (en) 2017-01-25 2018-08-02 Merit Medical Systems, Inc. Methods and systems for facilitating laminar flow between conduits
US11026704B2 (en) 2017-03-06 2021-06-08 Merit Medical Systems, Inc. Vascular access assembly declotting systems and methods
US10925710B2 (en) 2017-03-24 2021-02-23 Merit Medical Systems, Inc. Subcutaneous vascular assemblies for improving blood flow and related devices and methods
US11179543B2 (en) 2017-07-14 2021-11-23 Merit Medical Systems, Inc. Releasable conduit connectors
EP3655086A4 (en) 2017-07-20 2021-04-07 Merit Medical Systems, Inc. Methods and systems for coupling conduits
WO2022006190A1 (en) * 2020-07-02 2022-01-06 Kaiser Clayton A Anastomotic device

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2453056A (en) * 1947-03-12 1948-11-02 Zack William Edwin Surgical anastomosis apparatus and method
US3435823A (en) * 1966-04-11 1969-04-01 Miles Lowell Edwards Anastomotic coupling with anti-pulse ring means
US3540451A (en) * 1967-02-28 1970-11-17 William V Zeman Drainage cannula with tissue connecting assemblies on both ends
US3774615A (en) * 1971-02-08 1973-11-27 Ceskoslovenska Akademie Ved Device for connecting or joining the ends of interrupted tubular organs in surgical operations without stitching

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2453056A (en) * 1947-03-12 1948-11-02 Zack William Edwin Surgical anastomosis apparatus and method
US3435823A (en) * 1966-04-11 1969-04-01 Miles Lowell Edwards Anastomotic coupling with anti-pulse ring means
US3540451A (en) * 1967-02-28 1970-11-17 William V Zeman Drainage cannula with tissue connecting assemblies on both ends
US3774615A (en) * 1971-02-08 1973-11-27 Ceskoslovenska Akademie Ved Device for connecting or joining the ends of interrupted tubular organs in surgical operations without stitching

Cited By (44)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4624257A (en) * 1982-06-24 1986-11-25 Anders Berggren Surgical instrument for performing anastomosis
US4917090A (en) * 1982-06-24 1990-04-17 Unilink, Inc. Method for performing an anastomosis
EP0129428A3 (en) * 1983-06-15 1986-01-15 Robert Roy Schenk Devices for joining anatomical structures
EP0129428A2 (en) * 1983-06-15 1984-12-27 Robert Roy Schenk Devices for joining anatomical structures
GB2141346A (en) * 1983-06-15 1984-12-19 Mulas Piero Giovanni Mechanical valve for closing a cutaneous stoma
US4607637A (en) * 1983-07-22 1986-08-26 Anders Berggren Surgical instrument for performing anastomosis with the aid of ring-like fastening elements and the fastening elements for performing anastomosis
EP0158316A3 (en) * 1984-04-10 1986-02-26 Walsh Manufacturing (Mississauga) Limited Anastomosis devices and kit
EP0158316A2 (en) * 1984-04-10 1985-10-16 Walsh Manufacturing (Mississauga) Limited Anastomosis devices and kit
WO1988004539A1 (en) * 1986-12-18 1988-06-30 Unilink Inc. Instrument for prevention of constrictions in the joint area at the appliance of branching on vessel
US5500014A (en) * 1989-05-31 1996-03-19 Baxter International Inc. Biological valvular prothesis
US5824061A (en) * 1989-05-31 1998-10-20 Baxter International Inc. Vascular and venous valve implant prostheses
US5609626A (en) * 1989-05-31 1997-03-11 Baxter International Inc. Stent devices and support/restrictor assemblies for use in conjunction with prosthetic vascular grafts
US5997573A (en) * 1989-05-31 1999-12-07 Baxter International, Inc. Stent devices and support/restrictor assemblies for use in conjunction with prosthetic vascular grafts
FR2649605A1 (en) * 1989-07-13 1991-01-18 France Chirurgie Instr Corneal implant
US5036868A (en) * 1990-01-29 1991-08-06 Unilink Inc. Anastomosis preparation technique
EP0518856A4 (en) * 1990-03-06 1993-02-03 University Of New Mexico Everting forceps
EP0518856A1 (en) * 1990-03-06 1992-12-23 Univ New Mexico Everting forceps.
EP0593600A1 (en) * 1991-07-04 1994-04-27 OWEN, Earl Ronald Tubular surgical implant
EP0593600A4 (en) * 1991-07-04 1995-02-22 Earl Ronald Owen Tubular surgical implant.
US5456714A (en) * 1991-07-04 1995-10-10 Owen; Earl R. Tubular surgical implant having a locking ring and flange
EP0550330A1 (en) * 1991-12-23 1993-07-07 ELA MEDICAL (Société anonyme) Ventricular cannulation device
FR2685208A1 (en) * 1991-12-23 1993-06-25 Ela Medical Sa VENTRICULAR CANULATION DEVICE.
US5843088A (en) * 1991-12-23 1998-12-01 Ela Medical Sa Tool and method for installation of a ventricular cannulation device
US5814005A (en) * 1991-12-23 1998-09-29 Ela Medical S.A. Ventricular cannulation device
EP0548521A1 (en) * 1991-12-26 1993-06-30 American Cyanamid Company Anastomotic device
US5776185A (en) * 1994-09-27 1998-07-07 Alessandro Verona Cardiovascular graft
WO1996009800A1 (en) * 1994-09-27 1996-04-04 Giliberti Umberto Cardiovascular graft
WO1998040036A1 (en) * 1997-03-13 1998-09-17 United States Surgical Corporation Graft attachment assembly
US6808498B2 (en) 1998-02-13 2004-10-26 Ventrica, Inc. Placing a guide member into a heart chamber through a coronary vessel and delivering devices for placing the coronary vessel in communication with the heart chamber
US8226670B2 (en) 2004-03-23 2012-07-24 Correx, Inc. Apparatus and method for connecting a conduit to a hollow organ
US8679138B2 (en) 2004-03-23 2014-03-25 Correx, Inc. Apparatus and method for forming a hole in a hollow organ
US7799041B2 (en) 2004-03-23 2010-09-21 Correx, Inc. Apparatus and method for forming a hole in a hollow organ
US7510561B2 (en) 2004-03-23 2009-03-31 Correx, Inc. Apparatus and method for connecting a conduit to a hollow organ
US8277465B2 (en) 2004-12-15 2012-10-02 Correx, Inc. Apparatus and method for connecting a conduit to a hollow vessel
WO2007117612A1 (en) * 2006-04-06 2007-10-18 Correx, Inc. Apparatus and method for suturelessly connecting a conduit to a hollow organ
US8313013B2 (en) 2006-04-06 2012-11-20 Synovis Life Technologies, Inc. Method and assembly for anastomosis
EP1908420B1 (en) * 2006-10-06 2009-11-25 Ethicon Endo-Surgery, Inc. Anastomotic ring device with locking means
US8414603B2 (en) 2007-09-25 2013-04-09 Correx, Inc. Applicator, assembly, and method for connecting an inlet conduit to a hollow organ
WO2012033847A1 (en) * 2010-09-07 2012-03-15 Spence Paul A Cannula systems and methods
US9463268B2 (en) 2010-09-07 2016-10-11 Paul A. Spence Cannula systems and methods
US9585991B2 (en) 2012-10-16 2017-03-07 Heartware, Inc. Devices, systems, and methods for facilitating flow from the heart to a blood pump
US10322217B2 (en) 2012-10-16 2019-06-18 Heartware, Inc. Devices, systems, and methods for facilitating flow from the heart to a blood pump
US9808283B2 (en) 2013-12-04 2017-11-07 Heartware, Inc. Apparatus and methods for cutting an atrial wall
US10660669B2 (en) 2013-12-04 2020-05-26 Heartware, Inc. Apparatus and methods for cutting an atrial wall

Also Published As

Publication number Publication date
US4366819A (en) 1983-01-04
CA1175726A (en) 1984-10-09
EP0064535A4 (en) 1983-10-26
EP0064535A1 (en) 1982-11-17

Similar Documents

Publication Publication Date Title
US4366819A (en) Anastomotic fitting
US4368736A (en) Anastomotic fitting
US4441215A (en) Vascular graft
CA2381820C (en) Methods and apparatus for measuring valve annuluses during heart valve-replacement surgery
US6458140B2 (en) Devices and methods for interconnecting vessels
US6585762B1 (en) Arteriovenous grafts and methods of implanting the same
JP4409803B2 (en) Valve assembly for use in a lumen of a vessel and method for making the valve assembly
CN102772272B (en) vascular repair device
US5047050A (en) Internal prosthesis with radiopaque annular portions
US7892247B2 (en) Devices and methods for interconnecting vessels
US6106550A (en) Implantable attaching ring
US5997563A (en) Implantable stent having variable diameter
US5824061A (en) Vascular and venous valve implant prostheses
JP4203934B2 (en) Medical graft connector, method of manufacture and method of installation thereof
JP3282728B2 (en) Stentless heart valve and holder
US20040097979A1 (en) Aortic valve implantation device
WO1982001647A1 (en) Vascular graft
JP2001516616A (en) Suture ring with enhanced annular fusion
CA2235911A1 (en) Stent and stent-graft for treating branched vessels
Hufnagel et al. Experiences with new types of aortic valvular prostheses
JP2022516603A (en) Stent graft and how to use it
EP2120731B1 (en) Probe coupler assembly
US20020099392A1 (en) Autoanastomosis device and connection technique
US3374489A (en) Artificial heart valve
Fisher et al. The longer term patency of a compliant small diameter arterial prosthesis: the effect of the withdrawing of aspirin and dipyridamole therapy: the effect of reduced compliance

Legal Events

Date Code Title Description
AK Designated states

Designated state(s): AU NO

AL Designated countries for regional patents

Designated state(s): CH DE FR GB NL SE

WWE Wipo information: entry into national phase

Ref document number: 1981903155

Country of ref document: EP

WWP Wipo information: published in national office

Ref document number: 1981903155

Country of ref document: EP

WWW Wipo information: withdrawn in national office

Ref document number: 1981903155

Country of ref document: EP