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 method of making a self-expanding stent includes disposing a stent comprising a shape memory alloy about an inflatable body, and applying a coolant to a surface of the stent. The inflatable body is inflated to radially expand the stent to an expanded diameter from an initial diameter, and the coolant is reapplied to the surface of the stent. The inflatable body is deflated, and the stent is positioned about a mandrel sized to accommodate the expanded diameter of the stent, where the stent reaches a mandrel-defined diameter. The stent is heat set at the mandrel-defined diameter so as to impart a memory of an expanded configuration of the stent to the shape memory alloy.

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: An embolic protection device includes a foam body attached to a plurality of flexible struts. The foam body has a generally conical geometry and the bottom of the conical geometry having a generally conical recess. The filter portion has pores sized such that blood cells can pass through the foam body, but larger material such as objects would be trapped in the recess. Each strut is attached along the periphery of the foam body and extend from the first end of the foam body to a connection point located proximate the first end.

Abstract: A two-stage method of compressing a stent entails providing an expandable stent (100,105) in a radially expanded state. An outward pressure is applied to an inner surface of the tubular framework to support the stent, and a diameter of the stent is reduced to a first compressed diameter (D1) while applying the outward pressure. The outward pressure is halted after reaching the first compressed diameter. According to an embodiment in which the stent is balloon-expandable, a delivery balloon catheter (130) comprising an uninflated balloon in a delivery configuration is inserted into the lumen after halting the outward pressure. The diameter of the stent is reduced to a second compressed diameter (D2) smaller than the first compressed diameter to crimp the stent onto the delivery balloon catheter.

Abstract: A stent deployment system, handle, and method of loading of a medical device are provided. The system includes an outer catheter having an inner liner extending past the end of the outer catheter and an inner catheter disposed within the outer catheter. The inner liner is inverted and attached to the inner catheter. Relative movement between the outer and the inner catheters can urge the inner liner to peel away from the medical device. A handle is disposed at the proximal end of the outer catheter, and may include a splitter configured to slice the wall of the tubular member. The handle may also include a rotatable mechanism that can be attached to the tubular member. Rotation of the rotatable mechanism retracts a portion of the tubular member into the handle and winds the sliced portion about the rotatable mechanism.

Abstract: A stent introducer apparatus comprises a sheath for surrounding a stent member, with the sheath having a longitudinal slit extending from one end along at least a substantial part of the length thereof, and a sheath withdrawal device comprising a reel for winding up the sheath. A second sheath may surround the slit portion of the sheath. An intermediate guide member can smooth the withdrawal procedure and flatten the sheath before it is wound on the reel. The intermediate guide member may include at least one of a second reel or a slot-defining member. The reel may be operated by means of a gear system. A method of deploying a stent member is also provided.

Abstract: A vascular introducer for accessing a circulatory system of a patient includes a sheath and a dilator. The sheath includes a fitting attached at a proximal end, and includes a liner that is longer than a core tube. A proximal segment of the liner is attached to an inner surface of the core tube, but a distal segment of the liner is everted to cover an outer surface of a distal segment of the core tube. The dilator is positioned in the sheath and includes a tapered distal segment that extends beyond a distal end of the sheath. A handle is attached to the proximal end of the dilator and extends proximally from the fitting. During a procedure, a blood vessel may constrict and grip the sheath. During withdrawal of the sheath, the core tube is slid within a first portion of the everted distal segment of the liner while another portion of the liner is de-everting.

Abstract: The present invention provides apparatus and methods for treating a vascular condition formed within a vessel by providing a balloon having proximal and distal regions and a stent configured to be disposed within the balloon. When the balloon is partially or fully inflated, the stent may be advanced within the confines of the balloon and then expanded to engage an inner surface of the balloon. The stent urges the balloon against the vessel wall, and the proximal and distal regions of the balloon then are cut to leave the balloon and stent within the vessel. The balloon may comprise a collagenous extracellular matrix material to facilitate fusion of the balloon with the vessel wall.

Abstract: A coated stent (20) for use in a medical procedure and methods of manufacturing the coated stent (20) are described. A stent component (30) has an expanded state in which an inner diameter (ds) of the stent (30) is less than or equal to an outer diameter (dc2) of a coating (40), thereby causing an inner surface (35) of the stent (30) to engage the outer surface (42) of the coating (40). In one exemplary method of manufacture, the stent (30) is disposed over the coating (40) when the coating (40) is provided with a first, smaller outer diameter (dc1). The coating (40) then is radially expanded to a second, larger outer diameter (dC2), which is greater than or equal to the inner diameter (ds) of the stent (30), to cause the outer surface (42) of the coating (40) to engage the inner surface (35) of the stent (30).

Abstract: A catheter tip assembly (50) is provided with a catheter tip (56) and an inner catheter (54). The catheter tip (56) has a tapered proximal end, an elongate center portion, and a tapered distal end. The inner catheter (54) includes a narrow proximal portion, a narrow elongate center portion (66), and a wide distal end (68). The catheter tip (56) is disposed within the wide distal end (68) of the inner catheter (54). One advantage of the catheter tip assembly is that no proximal-facing edge is formed at the transition between the narrow elongate center portion of the inner catheter and the catheter tip, which may help reduce the risk of the catheter tip snagging on a stent during use.

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: An expandable roll sock delivery catheter includes an inner tube, an outer tube having a distal outer tube end, and a medical device, such as a self-expanding stent, collapsibly disposed over the inner tube and concentrically oriented between the inner tube and the outer tube. A hollow tube of expandable balloon material extends from the distal outer tube end, the balloon material being substantially disposed in its entirety within a distal end portion of the outer tube. The balloon material is folded back into the outer tube and over the device as a single layer of balloon material connectively linked to the inner tube proximal to the self-expanding device so as to form an expandable roll sock balloon. The roll sock balloon defines an inflation lumen disposed between the outer tube and inner tube, whereby the inflation lumen is configured for expansion of the roll sock balloon following release of the device.

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: An expandable roll sock delivery catheter includes an inner tube, an outer tube having a distal outer tube end, and a medical device, such as a self-expanding stent, collapsibly disposed over the inner tube and concentrically oriented between the inner tube and the outer tube. A hollow tube of expandable balloon material extends from the distal outer tube end, the balloon material being substantially disposed in its entirety within a distal end portion of the outer tube. The balloon material is folded back into the outer tube and over the device as a single layer of balloon material connectively linked to the inner tube proximal to the self-expanding device so as to form an expandable roll sock balloon. The roll sock balloon defines an inflation lumen disposed between the outer tube and inner tube, whereby the inflation lumen is configured for expansion of the roll sock balloon following release of the device.

Abstract: According to one embodiment there is disclosed a device including a shield member including an ECM material and a retaining member conformable to maintain at least a portion of the shield member in a desired relationship with respect to an area of a blood vessel to be treated or repaired.

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 method for deploying a stent delivery system having a blowmolded holder is provided. The stent is configured to expand from a first diameter to a second diameter. The holder is blowmolded to an inner surface of the compressed state. The holder contacts the inner surface and at least portions of side surfaces of the stent, and the holder and the stent have an interference fit therebetween. The deployment method includes delivering the compressed stent placed on the blowmolded holder and the holder into a predetermined deployment side. The deployment method further includes releasing the stent from interference with the holder and expanding the stent from the compressed stent to the expanded stent.

Abstract: A medical device including a tube having a coil fitted around at least a part of an inner liner, such as PTFE, and a braid extending over at least part of the coil. A polymeric layer is positioned over the braid to adhere to the inner liner. A portion of the coil advantageously comprises a polymer, such as PEEK, while the coil may also have a metal portion. The polymer coil may extend along at least at the proximal region of the tube, and the metal coil may extend along at least at the distal region of the tube. A polymer coil, a metal coil or any combination thereof can extend along the intermediate region of the tube. The polymer coil can be configured so that the tube is longitudinally splittable with a cutting instrument.