Abstract: A tubular prosthesis delivery system has an inner tubular member having a distal end including a prosthesis-carrying portion and a proximal end intended to remain outside the patient. An outer tubular member has a distal end spaced from the prosthesis-carrying portion of the inner member. A coupling member couples the inner and outer tubular members to each other in fixed relationship generally at a location intended to remain outside the patient. An intermediate tubular member located between the inner and outer tubular members has a distal end adapted to cover the tubular prosthesis and a proximal end that projects proximally beyond the proximal ends of both the inner and outer tubular members. The proximally projecting end of the intermediate tubular member is longitudinally movable with respect to the coupled inner and outer tubular members by a distance sufficient to retract the intermediate tubular member distal end from any position covering the prosthesis carried by the inner member.

Abstract: An anastomosis device (12) for advantageously bridging an artery and a vein. The anastomosis device includes a tubular graft (15) with first and second ends (47 and 48) and a longitudinal passageway extending longitudinally through the graft. The device further includes a first stent (10) disposed about the first end of the tubular graft and a second stent (10) disposed about the second end of the tubular graft. Each of the first and second stents has a plurality of hooks or barbs (11) pointed or releasable to the point toward the other end of the graft.

Abstract: Prosthetic valves for implantation in a body vessel are provided. Prosthetic valves according to the invention comprise first and second frame members and a graft member at least partially disposed between the first and second frame members. The graft member forms a valve that permits fluid flow through the body vessel in a first direction and substantially prevents fluid flow through the body vessel in a second, opposite direction.

Abstract: A stent including a stent wire comprising a plurality of filaments twisted into a bundle having a helix, the stent wire bent into a pattern having a plurality of substantially straight wire sections separated by a plurality of bends. The pattern of the stent wire is spirally wound about a central axis in the same direction as the helix formed by the plurality of filaments. Each of the filaments in a bend have a cylindrical cross-section where at least one of the plurality of filaments is displaced and spaced from an immediately adjacent filament in the bend.

Abstract: The present invention is directed to apparatus and methods for gaining percutaneous access to body anatomy, for example an organ or a body lumen. According to one aspect of the invention, an apparatus is provided comprising a needle and an outer sheath. The needle is receivable within the outer sheath and comprises a plurality of outer diameters. A distal portion of the needle has a lesser diameter than a proximal portion of the needle. Other embodiments are also disclosed.

Abstract: A dual balloon catheter assembly and method of use thereof are provided. The dual balloon catheter assembly may be used in a cryoplasty treatment that is provided in combination with eluting an antiproliferative to reduce and/or eliminate vessel fractures, thereby inhibiting proliferative response after angioplasty.

Abstract: The invention relates to a prosthetic valve for regulating fluid flow through a body lumen. The valve includes a frame and a valve member comprising at least one semi-rigid leaflet and at least one flexible leaflet. The at least one semi-rigid leaflet comprises a first portion and a second portion, the first portion attached to the frame and the second portion free of the frame. The at least one semi-rigid leaflet is slanted in a retrograde direction from the second portion to the first portion. The at least one flexible leaflet comprises a first portion and a second portion, the first portion attached to the frame and the second portion free of the frame. The at least one flexible leaflet is slanted in a retrograde direction from the first portion to the second portion when at rest.

Abstract: Methods of implanting a prosthetic valve in a body vessel are provided. A first expandable frame member is delivered to and deployed at a point of treatment in a body vessel. A second expandable frame member is delivered to the point of treatment. The second expandable frame member has an attached graft member that forms a valve adapted to permit fluid flow through the body vessel in a first direction and to substantially prevent fluid flow through the body vessel in a second, opposite direction. After deployment of the first expandable frame member, the second expandable frame member is deployed at the point of treatment such that the second frame member is positioned radially inward of the first frame member within said body vessel to form a prosthetic valve.

Abstract: An endoluminal prosthesis with a moveable fenestration including a tubular graft body having a proximal end, a distal end, a surface plane at least one fenestration having a perimeter disposed in a sidewall of the tubular body between the proximal end and the distal end, a first biocompatible graft material, and a second biocompatible graft material adjacent to and surrounding the perimeter of the at least one fenestration. The second biocompatible graft material has at least one characteristic different from the first biocompatible graft material and is more flexible than the first biocompatible graft material and is movable relative to the surface plane of the tubular graft body.

Abstract: A medical balloon having a resistance to circumferential tearing comprises a substantially cylindrical portion disposed between first and second tapered portions that have a decreasing cross-sectional area along a length thereof away from the cylindrical portion. The substantially cylindrical portion includes first and second end portions and a midsection disposed therebetween. The midsection includes a first region having a first resistance to tearing and a second region having a second lower resistance to tearing, where the second region extends about only a portion of the circumference of the cylindrical portion and does not extend beyond the midsection.

Abstract: An endoluminal graft includes a unitary tube of graft material forming two adjacent legs that are integral and monolithic to each other. The graft can be part of a prosthesis assembly for treatment of branched vascular systems and can function as an integral bifurcated leg extension prosthesis in combination with a main bifurcated prosthesis. In treating abdominal aortic aneurysms, the graft can be deployed within both iliac arteries.

Abstract: An introducer apparatus and a method for forming an introducer apparatus. The apparatus comprises an inner liner having a passageway extending longitudinally therethrough. A coil in a stressed, radially expanded condition is positioned longitudinally around said inner tube. A polymeric outer tube is positioned longitudinally around the coil and the inner liner, and is bonded to the inner liner through the spaces between the turns of the coil. The polymeric outer tube is formed in a manner such that it maintains the coil in its stressed radially expanded condition. In a preferred embodiment, the inner liner and outer tube comprise a polyimide.

Abstract: In at least one embodiment of the present invention, a device for mixing and dispensing a bone cement mixture is provided. The device comprises an injector housing having a chamber for containing a first and a second bone cement component and a second housing having a chamber for containing a flexible wire mixing element. A plunger actuates within the chamber of the second housing to transfer the wire mixing element to the injector housing for mixing the first and second bone cement components to form the bone cement mixture. The plunger rotates the wire mixing element to mix the bone cement mixture. Thereafter, the wire mixing element is withdrawn from the injector housing and the injector housing is assembled with an injector handle. A plunger coupled to the injector handle advances through the injector chamber to dispense the bone cement mixture from the device.

Abstract: Medical devices for implantation in a body vessel are provided. Each medical device comprises a main body, a valve, and a vessel engaging member. The vessel engaging member is disposed on an outer surface of the main body. Kits including a plurality of vessel engaging members for use with one or more valve members are also provided. The vessel engaging members have varying radial dimensions, allowing assembly of medical devices having varying radial dimensions. Methods of treating a patient using medical devices according to the invention are also provided.

Abstract: A method of forming an introducer sheath having a crease-free tapered distal tip portion. A mandrel is provided having an outer configuration comprising an elongated body and a tapered distal tip portion. A generally tubular inner liner comprising heat shrinkable PTFE, is positioned over the mandrel. The inner liner is heat shrunk to the outer configuration of the mandrel, in a manner that avoids the formation of creases along the inner diameter of the liner. A reinforcing member is positioned over a length of the inner liner, and an outer jacket is positioned over the reinforcing member and the inner liner. The liner, reinforcing member, and outer jacket are heated in a heat shrink enclosure, whereby the outer jacket melts and bonds to an outer surface of the inner liner.

Abstract: An introducer sheath and a method for making the sheath. The sheath includes a fluoropolymer liner having a passageway extending longitudinally therethrough. An inner jacket is positioned longitudinally over the liner, and the inner surface of the inner jacket is bonded to the outer surface of the liner. An outer jacket is positioned longitudinally over the inner jacket, and the inner surface of the outer jacket is bonded to the outer surface of the inner jacket. A reinforcing coil is encapsulated within the inner jacket and the outer jacket.

Abstract: A system and method for loading an endoprosthesis, such as a stent or valve, into an introducer is provided that permits interventionalists to load the endoprosthesis easily at the bedside. The system can include a compressor for compressing the endoprosthesis to a cross-sectional area less than the cross-sectional area of the introducer lumen. The compressor has a funnel portion at one end where the un-compressed endoprosthesis can be introduced and another end where the introducer and sleeves of a split sleeve device are inserted. The sleeves conform to the compressor passage and surround the endoprosthesis to collapse the endoprosthesis. The split sleeve device also includes a mounting device coupled to the sleeves. The endoprosthesis is compressed and loaded into the introducer by the relative movement of the mounting device and the compressor, where the endoprosthesis remains generally stationary while being compressed and loaded in order to avoid potentially compromising the endoprosthesis.

Abstract: In at least one embodiment of the present invention, an introducer for use in inserting a medical device into a body vessel of a patient is provided. The introducer comprises a housing having a proximal opening, a distal opening and a chamber extending therebetween. A seal in diaphragm form is disposed in the chamber. The seal is formed of polymeric material having a first phase transition temperature higher than about body temperature and a second phase transition temperature that is less than the first phase transition temperature but is greater than about room temperature. The seal is in a first configuration and has an opening formed therethrough when at about room temperature for advancing the medical device through the seal. The seal self-configures to a second configuration when at a temperature of at least the second phase transition temperature for obstructing the body fluid from flowing through the opening of the seal.

Abstract: A malecot device includes a textile material covering its deployable malecot wing portion. The textile material is woven in a manner allowing it to be compactly disposed around an undeployed malecot and then expanded to cover malecot wings when those wings are deployed to an expanded outer device diameter.

Abstract: An intraluminal system for retrieving an implantable medical device from a body vessel includes, according to one embodiment, a grasping component including at least one deployable arm, where a proximal end of the arm is configured to extend away from a longitudinal axis of the system when deployed, and a first sheath disposed adjacent to the grasping component, where the first sheath includes a radially expandable portion at a distal end thereof. A second sheath overlies the first sheath and the grasping component. Relative motion between the second sheath and the grasping component allows the proximal end of the deployable arm to be deployed for grasping a distal portion of an implantable medical device, and relative motion between the second sheath and the first sheath allows the expandable portion of the first sheath to radially expand to receive a proximal portion of the implantable medical device.