Abstract: A device includes a tubular substrate and a support member. The support member includes a component that is elastically deformable and elastically recoverable. The support member wraps around and adheres to an abluminal surface of the tubular substrate. The device is adapted for use in an anatomical conduit. For example, the device may be adapted for bypassing an anatomical conduit, for creating an arteriovenous shunt, or as a support structure for maintaining an opening in an anatomical conduit.

Abstract: A method for preparing a stent-graft for intraluminal delivery, including positioning an expanded polytetrafluoroethylene (ePTFE) substrate over a support mandrel, coupling a shape memory member to a polymer cladding to form a polymer clad member, winding the polymer clad member in an overlapping helical manner onto a surface of the ePTFE substrate, joining and sealing adjacent overlapping regions of the polymer clad member together and to the surface of the ePTFE substrate to form a stent-graft, manipulating the stent-graft from a larger first diameter to a smaller second diameter, and loading the stent-graft into a restraining sheath at the smaller second diameter.

Abstract: A method for forming a self-expanding stent-graft, including coupling a shape memory member to a polymer cladding to form a polymer clad member, disposing a length of the polymer clad member in an overlapping helical manner about a longitudinal axis, joining and sealing adjacent overlapping regions of the polymer clad member to form a stent-graft, manipulating the stent-graft from a first diameter to a second diameter smaller than the first diameter, and loading the stent-graft into a restraining sheath at the second diameter, the restraining sheath preventing expansion of the stent-graft from the second diameter to the first diameter.

Abstract: A method for forming a self-expanding stent-graft, including coupling a shape memory member to a polymer cladding to form a polymer clad member, disposing a length of the polymer clad member in an overlapping helical manner about a longitudinal axis, joining and sealing adjacent overlapping regions of the polymer clad member to form a stent-graft, manipulating the stent-graft from a first diameter to a second diameter smaller than the first diameter, and loading the stent-graft into a restraining sheath at the second diameter, the restraining sheath preventing expansion of the stent-graft from the second diameter to the first diameter.

Abstract: A method for forming a self-expanding stent-graft, including coupling a shape memory member to a polymer cladding to form a polymer clad member, winding a length of the polymer clad member about a mandrel so that adjacent windings include regions of polymer cladding that overlap, heating the wound polymer clad member to join and seal the overlapping regions to one another, manipulating the stent-graft from a first diameter to a second diameter smaller than the first diameter, and loading the stent-graft into a restraining sheath, wherein the restraining sheath prevents the stent-graft from reverting to the first diameter.

Abstract: A method for forming a self-expanding stent-graft, including coupling a shape memory member to a polymer cladding to form a polymer clad member, winding a length of the polymer clad member about a mandrel so that adjacent windings include regions of polymer cladding that overlap, heating the wound polymer clad member to join and seal the overlapping regions to one another, manipulating the stent-graft from a first diameter to a second diameter smaller than the first diameter, and loading the stent-graft into a restraining sheath, wherein the restraining sheath prevents the stent-graft from reverting to the first diameter.

Abstract: A method for forming a self-expanding stent-graft. The method includes coupling a shape memory member to a polymer cladding to form a polymer clad member, winding a length of the polymer clad member about a mandrel so that the polymer cladding has overlapping regions that form seams, and heating the wound polymer clad member to join and seal the overlapping regions to one another.

Abstract: A method for making an endoluminal prosthesis for implantation within a body lumen to maintain luminal patency, the prothesis including a support structure, such as a wire member, and a polymer component, such as a polymer cladding. The method may include joining a wire member to a polymer cladding, helically wrapping a length of the joined support wire member and polymer cladding such that adjacent windings of the polymer cladding have overlapping regions, and heating the joined support wire member and polymer cladding above the melt point of the polymer cladding.

Abstract: An endoluminal prosthesis for implantation within a body lumen to maintain luminal patency, including a support structure and a polymer component, which may be in the form of a wire member joined to a polymer cladding. The support structure may be formed of shape memory alloys, which exhibit either shape memory or pseudoelastic properties, or from an elastic material having an inherent spring tension such as spring steel, braided stainless steel wire, or composite materials, such as woven or braided carbon fibers. The polymer cladding may be formed from a variety of suitable materials.

Abstract: A method for making an endoluminal prosthesis for implantation within a body lumen to maintain luminal patency, the prothesis including a support structure, such as a wire member, and a polymer component, such as a polymer cladding. The method may include joining a wire member to a polymer cladding, helically wrapping a length of the joined support wire member and polymer cladding such that adjacent windings of the polymer cladding have overlapping regions, and heating the joined support wire member and polymer cladding above the melt point of the polymer cladding.

Abstract: Shape memory alloy and elastically self-expanding endoluminal support structures which are at least partially encapsulated in a substantially monolithic expanded polytetrafluoroethylene (“ePTFE”) covering. An endoluminal stent, which has a reduced diametric dimension for endoluminal delivery and a larger in vivo final diametric diameter, is encapsulated in an ePTFE covering which circumferentially covers both the luminal and abluminal walls along at least a portion of the longitudinal extent of the endoluminal stent. The shape memory endoluminal stent is fabricated from a shape memory alloy which exhibits either shape memory or pseudoelastic properties or from an elastic material having an inherent spring tension such as spring steel, braided stainless steel wire, or composite materials, such as woven or braided carbon fibers.

Abstract: Shape memory alloy and elastically self-expanding endoluminal support structures which are at least partially encapsulated in a substantially monolithic expanded polytetrafluoroethylene (“ePTFE”) covering. An endoluminal stent, which has a reduced diametric dimension for endoluminal delivery and a larger in vivo final diametric diameter, is encapsulated in an ePTFE covering which circumferentially covers both the luminal and abluminal walls along at least a portion of the longitudinal extent of the endoluminal stent. The shape memory endoluminal stent is fabricated from a shape memory alloy which exhibits either shape memory or pseudoelastic properties or from an elastic material having an inherent spring tension such as spring steel, braided stainless steel wire, or composite materials, such as woven or braided carbon fibers.

Abstract: Shape memory alloy and elastically self-expanding endoluminal support structures which are at least partially encapsulated in a substantially monolithic expanded polytetrafluoroethylene (“ePTFE”) covering. An endoluminal stent, which has a reduced diametric dimension for endoluminal delivery and a larger in vivo final diametric diameter, is encapsulated in an ePTFE covering which circumferentially covers both the luminal and abluminal walls along at least a portion of the longitudinal extent of the endoluminal stent. The stent and ePTFE covering are helically wound into an open cylindrical configuration with adjacent windings forming overlapping regions of ePTFE covering bonded to one another.

Abstract: A radially expandable endoluminal covered stent assembly and a method and apparatus for making the same. A longitudinally and radially expanded polytetrafluoroethylene tubular graft is circumferentially engaged about one or more radially expandable stents and is retained thereon by a radial recoil force exerted by the tubular graft against the stent. The graft is retained on the stent or stents prior to and during endoluminal delivery and radial expansion without the use of adhesives, sutures or other attachment means. Further, upon radial expansion the stent or stents do not require retaining means for preventing contraction, despite the inherent recoil imparted by the tubular graft. The covered stent is assembled by joining a dilation mandrel and a stent mandrel, placing the graft on the dilation mandrel where it is radially expanded, and passing the expanded graft over the stent that is positioned on the stent mandrel.

Abstract: A dual porosity PTFE tube including an inner surface of expanded PTFE material having a first porosity and an outer surface of expanded PTFE material having a porosity different from that of the inner surface. The preferred method includes the step of forming inner and outer preformed tubular billets of PTFE resin particles mixed with a lubricant; the outer billet is adapted to closely fit around and concentric to the inner billet. Porosity of the inner and outer surfaces is varied by changing, in the respective billets, the lubrication level and/or the PTFE resin characteristic average particle size. The inner billet is placed inside the outer billet, and the two are extruded together, thereby melding the two billets. The extrudate is then longitudinally expanded and sintered. The inner surface of the resulting PTFE tube exhibits a different porosity than the outer surface of the tube; the porosities of the inner and outer surfaces are both within a range of about 0.10-200 .mu..

Abstract: A dual supported intraluminal graft comprising a biocompatible flexible layer sandwiched between two structural support layers. The preferred embodiment comprises a first structural support, such as a stent, which is concentrically retained within a tubular shaped PTFE graft which is concentrically retained within a second structural support, such as a stent. The ends of the PTFE graft may be folded back onto the outer surface of the second structural support thereby forming flaps. Upon radial expansion of the preferred embodiment, the stent/graft/stent assembly forms inseparable layers.

Abstract: A dual porosity PTFE tube including an inner surface of expanded PTFE material having a first porosity and an outer surface of expanded PTFE material having a porosity different from that of the inner surface. The preferred method includes the step of forming inner and outer preformed tubular billets of PTFE resin particles mixed with a lubricant; the outer billet is adapted to closely fit around and concentric to the inner billet. Porosity of the inner and outer surfaces is varied by changing, in the respective billets, the lubrication level and/or the PTFE resin characteristic average particle size. The inner billet is placed inside the outer billet, and the two are extruded together, thereby melding the two billets. The extrudate is then longitudinally expanded and sintered. The inner surface of the resulting PTFE tube exhibits a different porosity than the outer surface of the tube; the porosities of the inner and outer surfaces are both within a range of about 0.10-200 .mu..

Abstract: A stent-graft delivery system which includes a catheter, an expandable balloon having non-tapered ends positioned near the distal end of the catheter, a stent circumferentially positioned around a center of the balloon, and a graft circumferentially positioned around the stent. The balloon configuration comprising non-tapered ends may be achieved by 1) preforming the balloon to the desired geometry which comprises substantially non-tapered ends; 2) positioning a non-compliant sheath over each of the ends of an existing balloon having tapered ends, or 3) invertedly attaching the first and second ends of a compliant tubular member to the catheter to form the desired balloon configuration. The desired balloon configuration is a balloon geometry which uniformly conforms to the geometry of the stent-graft assembly. A method for introducing the stent-graft delivery system into a blood vessel are also disclosed.

Abstract: An apparatus and process for expanding polymer films such as PTFE films includes gripping the unexpanded film about its periphery with a number of symmetrically disposed gripping members each equidistant from the center of the film. The gripping members are simultaneously rotated through an arc away from the center of the film, as by pivotally securing each gripping member to the end of an associated expansion arm and rotating the end of each expansion arm away from the center of the film while maintaining the gripping members equidistant from the center of the film. The expansion arms are uniformly rotated by a geared shaft powered by a drive mechanism that extends through the wall of an oven for coupling to an external motor. Also disclosed is an expanded PTFE film made in accordance with such process.

Abstract: An apparatus for expanding polymer films such as PTFE films includes gripping the unexpanded film about its periphery with a number of symmetrically disposed gripping members each equidistant from the center of the film. The gripping members are simultaneously rotated through an arc away from the center of the film, as by pivotally securing each gripping member to the end of an associated expansion arm and rotating the end of each expansion arm away from the center of the film while maintaining the gripping members equidistant from the center of the film. The expansion arms are uniformly rotated by a geared shaft powered by a drive mechanism that extends through the wall of an oven for coupling to an external motor. Also disclosed is an expanded PTFE film made in accordance with such process.