Abstract: The disclosure relates to a woven fabric for use in an implantable medical device. The woven fabric comprises shape memory element strands woven with textile strands. At least one of the shape memory element strands has at least one float of at least five textile strands between binding points.

Abstract: A process to load a medical device comprising a shape memory material into a delivery system is described herein. According to one aspect, the method includes applying a force to the medical device to obtain a delivery configuration thereof, where the device is at a first temperature within an R-phase temperature range of the shape memory material during application of the force. The medical device is cooled in the delivery configuration to a second temperature at or below a martensite finish temperature of the shape memory material. The force is then removed from the medical device, and the device is loaded into a delivery system. Preferably, the medical device substantially maintains the delivery configuration during the loading process.

Abstract: A stent delivery system includes a stent having at least one eyelet and at least one rivet and a holder supporting the stent, wherein the holder includes a first section having a first diameter and a second section having a second diameter. A sheath covers the stent and the holder. The rivets are attached to each of the eyelets. A first inner diameter of the stent at the position of the rivets is smaller than a second inner diameter of the stent at other positions because the rivets protrude inwardly. A shoulder is formed on the holder due to the difference between the first diameter and the second diameter of the holder. The shoulder is positioned distally adjacent the rivets. The shoulder interferes with the protruding rivets, thereby restraining the longitudinal movement of the stent relative to the holder. Although the sheath is pulled back, the stent does not jump out of the stent delivery system.

Abstract: A stent (30) formed from cannula and having flexible segments (31) and high hoop strength segments (32) alternating therealong. Longitudinal struts or tie bars (41) interconnect the segments. Minimal length reduction of the strut occurs upon expansion. In the high hoop strength segment (32), struts (37) in a zig-zag configuration (Gianturco Z-stent) are initially parallel in the unexpanded strut condition. In the flexible segment (31), struts (58) extend from a respective C-shaped bend (59) to converge at the opposite ends thereof when unexpanded. In one embodiment, certain adjacent struts (39–41) of the hoop segment are spaced apart by elongated openings or gaps (46, 48) interposed therebetween and interconnected at their respective ends (42, 44) to form a T-shaped strut interconnection (45). The selected width (50, 51) of the first and third struts (54, 57) increases toward the ends (47, 48) of the elongated openings (46, 48) adjacent the strut interconnection (45).

Abstract: A medical device (10) including a tube (11) having a highly uniform and repeatable inner and outer diameter, the tube (11) possessing good trackability, pushability and torquability, and the tube (11) being highly resistant to collapse, necking or kinking during use. The tube (11) first includes a metal coil (14) in a stressed, radially expanded condition, the metal coil (14) preferably being formed as a flat wire. The tube (11) also includes a metal braid (16) extending over at least part of the coil (14). The tube (11) further includes a polymeric bonding layer (18) positioned over and contacting at least the coil (14). The polymeric layer (18) is preferably heat-shrinkable shrinkable tubing made of one or more of nylon or polyurethane. The tube (11) optionally includes an inner liner (20) beneath and in contact with at least part of the coil (14), the liner (20) preferably being composed of PTFE.

Abstract: A flexible, kink-resistant, delivery catheter or sheath (83) for percutaneously delivering implantable medical devices. The delivery catheter sheath includes a flat wire coil (95) with uniform spacing between the turns, which is compression fitted about and proximal the distal portion of an inner, lubricous material polytetrafluoroethylene tube (84). The delivery catheter or sheath further includes an outer tube (85) of a heat formable polyamide material, which is heat formed and compressed through the spaces between the turns of the wire coil to mechanically connect to the roughened outer surface of the inner tube. The distal portion (87) of the inner tube is expanded and everted or folded-back over itself and connected to the distal end of the outer tube to form a lumen having a larger diameter than the rest of the catheter.

Abstract: A stent tissue graft prosthesis (20) for repairing, excluding and/or reinforcing a vessel, duct and the like in a patient. The prosthesis includes an inner expandable stent (21) of which a tissue graft (24) and preferably a multilayered tissue construct (33) is disposed thereon for application to the host tissue of a vessel, duct and the like. The tissue construct includes an extracellular matrix material (36) such as small intestine submucosa (37) for remodeling the host tissue into the prosthesis. The prosthesis further includes an outer tubular member (25) such as an outer expandable stent (44) for retaining the tissue graft on the inner stent. The ends of the inner and outer stents are coincident with or extend beyond the ends of the tissue graft to prevent eversion or fold back of the tissue graft during withdrawal of a delivery catheter in a placement procedure.

Abstract: A stent (30) formed from cannula and having flexible segments (31) and high hoop strength segments (32) alternating therealong. Longitudinal struts or tie bars (41) interconnect the segments. Minimal length reduction of the strut occurs upon expansion. In the high hoop strength segment (32), struts (37) in a zig-zag configuration (Gianturco Z-stent) are initially parallel in the unexpanded strut condition. In the flexible segment (31), struts (58) extend from a respective C-shaped bend (59) to converge at the opposite ends thereof when unexpanded. In one embodiment, certain adjacent struts (39-41) of the hoop segment are spaced apart by elongated openings or gaps (46, 48) interposed therebetween and interconnected at their respective ends (42, 44) to form a T-shaped strut interconnection (45). The selected width (50, 51) of the first and third struts (54, 57) increases toward the ends (47, 48) of the elongated openings (46, 48) adjacent the strut interconnection (45).

Abstract: A medical device (10) including a tube (11) having a highly uniform and repeatable inner and outer diameter, the tube (11) possessing good trackability, pushability and torquability, and the tube (11) being highly resistant to collapse, necking or kinking during use. The tube (11) first includes a metal coil (14) in a stressed, radially expanded condition, the metal coil (14) preferably being formed as a flat wire. The tube (11) also includes a metal braid (16) extending over at least part of the coil (14). The tube (11) further includes a polymeric bonding layer (18) positioned over and contacting at least the coil (14). The polymeric layer (18) is preferably heat-shrinkable shrinkable tubing made of one or more of nylon or polyurethane. The tube (11) optionally includes an inner liner (20) beneath and in contact with at least part of the coil (14), the liner (20) preferably being composed of PTFE.

Abstract: Disclosed is a catheter, more particularly a guiding catheter (10). The guiding catheter (10) comprises an inner layer (46), a reinforcement layer (24), and an outer layer (16). The reinforcement layer (46) generally extends from the proximal end (14) of the guiding catheter (10) and terminates proximal to the distal end (18) of the guiding catheter. The distal portion of the guiding catheter (10) comprises a soft material to facilitate manipulation. The reinforcement layer (24) can be attached to the inner layer (46) and the outer layer (16) attaches to both the reinforcement layer (24) and the inner layer (46). Proximal portion of the guiding catheter can have a folded cuff (52).

Abstract: Introducer sheath (10, 30, 40) having a flexible kink-resistant distal tip portion (26, 32, 42). A multilayer sheath structure is used, with an inner tube (12) such as PTFE having a coil (14) of wire wound therearound. A first length of outer tubing (20) such as of nylon is inserted over most of the coil-wound inner tube (12) in a manner exposing a distal length of coil-wound inner tube. A second length of outer tubing (22) with a softer durometer than first outer tubing length (20), is inserted over the exposed coil-wound inner tube and extends for a slight distance beyond the end of the coil. During heat application, the outer tubing lengths (20, 22) are melted to bond to each other and to flow between the spacings of the coil turns to bond to the roughened outer surface of the inner tube (12). The distal tip region corresponding to the second tubing length is flexible and is kink-resistant due to the coil (14).

Abstract: A soft tip guiding catheter for atraumatic insertion into delicate, tortuous coronary vessels and introduction of an angioplasty balloon catheter therethrough. The guiding catheter includes a main tubular portion and a soft tubular tip with cooperating bonding surfaces for increasing the contact area and strength of the thermal bond therebetween. The cooperating bonding surfaces each include a proximal ground taper portion with a braid material included therein and a distal longitudinal portion without the braiding material. The main portion preferably includes an inner layer of lubricous material, an outer layer of a polyether block amide, and a reinforcing braid positioned therebetween. The main tubular portion also includes distal and proximal segments heat shrink bonded together to provide changes in durometer along the length of the catheter. The layers of the main portion provide a thin catheter wall with pushability, torquability, and kink resistance.

Abstract: A flexible, kink-resistant, introducer sheath for percutaneous vascular access. The introducer sheath includes a flat wire coil with uniform spacing between the turns, which is compression fitted about an inner, lubricous material polytetrafluoroethylene tube. The introducer sheath further includes an outer tube of a heat formable polyamide material which is heat formed and compressed through the spaces between the turns of the wire coil to mechanically connect to the roughened outer surface of the inner tube. The distal end of the outer tube is tapered in a mold with additional polyamide outer tube material. The proximal end of the sheath is flared for connection to a connector fitting. In another aspect of the introducer sheath, the flat wire coil has an inner diameter less than the outer diameter of the inner tube. The coil is then expanded and wrapped around the inner tube to form a compression fit.

Abstract: A percutaneous release mechanism (57) for use with an intravascular treatment device (11) in an intravascular treatment system (10). The release mechanism includes an inner member (17) having a connection mechanism (18) positioned about the distal end (14) thereof for interconnection with another connection mechanism (12) positioned on an intravascular treatment device. The release mechanism also includes an outer member tube (13) of which the inner member is positioned therein. The first and second connection mechanisms are interconnectable and positionable in the passage (16) of the tube for delivering the treatment device in a delivery state to the treatment site.

Abstract: A percutaneous release mechanism (57) for use with an intravascular treatment device (11) in an intravascular treatment system (10). The release mechanism includes an inner member (17) having a connection mechanism (18) positioned about the distal end (14) thereof for interconnection with another connection mechanism (12) positioned on an intravascular treatment device. The release mechanism also includes an outer member tube (13) of which the inner member is positioned therein. The first and second connection mechanisms are interconnectable and positionable in the passage (16) of the tube for delivering the treatment device in a delivery state to the treatment site.

Abstract: A flexible, kink-resistant, introducer sheath for percutaneous vascular access. The introducer sheath includes a flat wire coil with uniform spacing between the turns, which is compression fitted about an inner, lubricous material polytetrafluoroethylene tube. The introducer sheath further includes an outer tube of a heat formable polyamide material which is heat formed and compressed through the spaces between the turns of the wire coil to mechanically connect to the roughened outer surface of the inner tube. The distal end of the outer tube is tapered in a mold with additional polyamide outer tube material. The proximal end of the sheath is flared for connection to a connector fitting. In another aspect of the introducer sheath, the flat wire coil has an inner diameter less than the outer diameter of the inner tube. The coil is then expanded and wrapped around the inner tube to form a compression fit.

Abstract: A flexible plastic material catheter having a distal tubular member portion with a greater than 75 weight percent loading of a radiopaque agent for radiographic viewing. The catheter comprises an elongated member having a proximal portion and a distal end portion with a flexible, radiopaque plastic material having a durometer lower than that of the proximal portion. The plastic material of the distal end portion comprises a homogeneous and evenly dispersed composition of a 20 weight percent base thermoplastic, elastomer material such as a polyether block amide and 80 weight percent loading of a radiopaque agent such as tungsten. This distal end portion plastic material exhibits a durometer of approximately 47 on the Shore D scale, whereas the polyether block amide material exhibits a durometer of approximately 40 on the Shore D scale. The flex modulus of the polyether block amide material is in a range of 23,000 to 75,000 pounds per square inch.

Abstract: A soft tip guiding catheter for atraumatic insertion into delicate, tortuous coronary vessels and introduction of an angioplasty balloon catheter therethrough. The guiding catheter includes a main tubular portion and a soft tubular tip with respective, matching external and internal tapers for increasing the contact area of the thermal bond. The outer and inner diameters of the main portion are uniform and match the respective outer and inner diameters of the soft tip for providing a uniform outer catheter surface and a continuous, uniform catheter passageway surface. The tapers further provide for a gradual change in durometer between the main portion and soft tip. The main portion preferably includes an inner layer of lubricous material, an outer layer of a polyether block amide, and a reinforcing braid positioned therebetween. The layers of the main portion provide a thin catheter wall with pushability, torquability, and kink resistance.

Abstract: A lockable sleeve drainage catheter is disclosed for percutaneous insertion into a patient and drainage of fluid therefrom. The drainage catheter includes a flexible distal end that is preformed for retaining the distal end of the catheter that is inserted in the patient. For insertion, the distal end is straightened with the use of a stiffening cannula that is inserted through the hollow passageway of the catheter. When the catheter is inserted in the patient, the stiffening cannula is removed, and a flexible tension member positioned within the passageway of the catheter is drawn to position the distal end in the desired retention configuration. A lockable sleeve positioned at the proximal end of the catheter draws the flexible tension member through the passageway of the elongated member tube to position the distal end in the retention configuration. The catheter also includes a locking collar at the proximal end of the elongated member tube having an annular recess formed therein.