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Methods and devices for coupling a device insertable within a mammalian body

Methods and devices for coupling a device insertable within a mammalian body description/claims

This application is a continuation of U.S. patent application Ser. No. 11/679,182 filed Feb. 27, 2007, which is a continuation of U.S. patent application Ser. No. 10/326,211 filed on Dec. 20, 2002, now U.S. Pat. No. 7,182,771, the entirety of which is incorporated herein by reference, which claims the benefit of U.S. Provisional Patent Applications 60/341,160 filed on Dec. 20, 2001; 60/369,835 filed Apr. 5, 2002; 60/381,805 filed May 21, 2002; 60/385,216 filed on May 31, 2002; 60/394,793 filed Jul. 9, 2002; 60/399,710 filed on Aug. 1, 2002; 60/408,032 filed Sep. 3, 2002; and 60/428,509 filed on Nov. 22, 2002.

The field of the inventions generally relates to cardiovascular and vascular devices, and, more particularly, to vascular couplers.

Cardiovascular and vascular diseases are treated pharmacologically, using interventional cardiology, and surgically. For example, interventional, catheter-based treatments include percutaneous transluminal coronary angioplasty (“PTCA”) with an angioplasty balloon to compress plaque to the wall of a coronary vessel, placement of a stent in a vessel to maintain the patency of the vessel, and atherectomy to use a cutting instrument to shave off and remove plaque from the lumen of the vessel. Surgical treatments include coronary artery bypass grafting procedures using cardiopulmonary support, beating heart techniques, minimally invasive approach, and robotically assisted instruments. In these procedures, the surgeon may use traditional, endoscopic, and/or laparoscopic instruments. In traditional coronary artery bypass grafting, the surgeon uses sutures to anastomose a synthetic or natural bypass vessel to, for example, the aorta at one end and a coronary artery at the other end, or from the internal mammary artery (“IMA”) to a coronary artery. To form an anastomosis between an internal mammary artery and a coronary artery, blood flow through the internal mammary artery must be temporarily stopped, typically by applying a removable clamp to the mammary artery. The mammary artery is then severed downstream from the clamp to create a free end. An incision is created in the target coronary artery downstream of the blockage. The free end of the mammary artery can then be connected to the incision in the coronary artery, typically by suturing, such that blood can flow from the mammary artery through the incision into the coronary artery. Typical traditional coronary artery bypass grafting procedures involve aortic clamping and a procedure time of approximately ten to twenty minutes per anastomosis. Coalescent Surgical markets a superelastic/shape memory suture that is used in an interrupted suture technique and reduces the anastomosis time. Like traditional bypass procedures, the superelastic/shape memory suture involves aortic clamping.

Some of the other devices used in beating heart and/or minimally invasive surgical treatments are produced by companies that include Advanced Bypass Technologies/Converge Medical, Inc., By-Pass, Cardica (formerly Vascular Innovations), Coalescent Surgical, Corvascular, Ethicon, HeartPort, Heart-Tech, Intellicardia, Onux Medical, Origin MedSystems, Inc. (Guidant), St. Jude Cardiovascular Group (including Vascular Science), Sulzer Carbomedics, Vasconnect, and Ventrica.

In one general aspect, a coupler configured to connect a first tubular vessel to an aperture in a second tubular vessel. The coupler includes one or more radially extending members and a substantially nonmetallic tubular member. The substantially nonmetallic tubular member comprising an outer wall, an inner wall defining a lumen having an open distal end and an open proximal end, and a circumferential ridge encircling the outer wall, the radially extending members extending from the distal end of the tubular member.

Embodiments of the coupler may include one or more of the following features. For example, the extending member may include a first segment and a second segment, the first segment being at an angle of 90° or less with respect to the second segment, the first segment extending from the tubular member. The second segment defines a region that is wider than a region defined by the first segment. The extending member may include a nickel titanium alloy and/or 17-7PH stainless steel. The proximal end of the tubular member may include a strain relief.

The coupler may further include at least one securing member mounted to the distal end of the tubular member, the securing member including a first segment positioned adjacent to the inner wall, a second segment positioned against the outer wall, and a third segment connecting the first segment and the second segment.

The coupler may further include at least one securing member mounted to the distal end of the tubular member, the securing member including a first segment positioned adjacent to the inner wall, a second segment positioned within the wall between the inner wall and the outer wall, and a third segment connecting the first segment and the second segment. The coupler may further include a gasket extending from the distal end of the tubular member, the radially extending members extending from the gasket. The tubular member may include one or more of silicone, ePTFE, polyurethane, and polyisoprene.

The coupler may further include a gasket extending from the distal end of the tubular member and a strain relief extending from the proximal end of the tubular member. The tubular member, the ridge, the gasket, and the strain relief are an integral unit.

In another general aspect, a method of fabricating a coupler the method including fabricating radially extending members; placing the radially extending members within a mold; injecting a material into the mold; allowing the material to cure to form the c coupler; and removing the coupler from the mold. The coupler includes a tubular member having an outer wall, an inner wall defining a lumen having an open distal end and an open proximal end, and a circumferential ridge encircling the outer wall. The radially extending members extend from the distal end of the tubular member.

Embodiment of the method may include one or more of the following. For example, the method may further comprise inserting one or more securing members at least partially within the mold. Fabricating the radially extending members comprises etching a sheet of a metal alloy. Fabricating the radially extending members further comprises one or more of forming, annealing, chemical polishing, and electropolishing. The material comprises one or more of silicone, ePTFE, polyurethane, and polyisoprene.

Allowing the material to cure to form the tubular member further comprises forming a ridge member around at least a portion of a circumference of the tubular member, forming a strain relief at the proximal end of the tubular member, and forming a gasket at the distal end of the tubular member.

In another general aspect, a method of deploying a coupler includes forming an opening in a wall of a tubular vessel; deflecting the radially extending members into a longitudinally extending configuration; inserting the extending members at least partially into the opening; and releasing the extending members. The coupler includes one or more radially extending members, a substantially nonmetallic tubular member, the tubular member comprising an outer wall, an inner wall defining a lumen having an open distal end and an open proximal end, and a circumferential ridge encircling at least a portion of the outer wall, the radially extending members extending from the distal end of the tubular member.

Embodiments of the method may include one or more of the following features. For example, deflecting the radially extending members into a longitudinally extending configuration further includes deflecting the radially extending members and at least partially inserting the extending members into an opening in a deployment tool, the deployment tool including a handle and a distal plate, the distal plate including the opening. Releasing the extending members further includes placing the plate on the vessel and removing the plate from around the coupler, the removal of the plate allowing the extending members to return to the radially extending configuration.

The couplers described herein enable clampless-bypass surgery. By not utilizing a clamp on the aorta, this method has the potential to significantly reduce the incidence of post surgical neuro cognoscente dysfunction, which occurs in up to approximately 50% of patients undergoing coronary artery bypass grafting (CABG) surgery.

Benefits that can be provided by the vascular couplers described herein include: (1) a coupler system that enables clampless bypass surgery—minimizing aortic manipulation by not requiring cross-clamping or aortic side-biting during coronary artery bypass grafting (CABG); (2) allowing or augmenting radial vessel expansion and contraction similar to a sutured anastomosis; (3) single piece coupler design in which no separate external vessel component (e.g., collar) is required; (4) reinforced anastomosis area (top vessel ridge) for strength; (5) limited foreign material contact with blood or vessel (even with non-everted version); (6) includes sutureless, sutured or combination versions; (7) includes aortic (proximal), coronary (distal), peripheral and valved versions for completeness; (8) does not enlarge or expand punch hole or arteriotomy during deployment; (9) once deployed, the coupler can ensure that all petals are in contact with the inside vessel wall; (10) no introducer or plunger is required for coupler deployment (although alternative versions may utilize these or similar accessories); (11) ability to employ multiple coupler deployment methods (push in, partially pull out; twist and advance; forward deflected (superelastic) or forward positioned (shape memory) petals, etc.); (12) much less costly to use with respect to other current systems because there are fewer components and accessories required; and (13) the coupler system is easy to learn and easy to use.

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