Abstract: A method of making an tubular intraluminal graft in the form of a tubular diametrically adjustable stent having a tubular covering of porous expanded polytetrafluoroethylene which is less than 0.10 mm thick. The covering may be on the exterior surface of the stent, or on the interior surface of the stent, or both. The covering may be affixed to the stent by an adhesive which is preferably fluorinated ethylene propylene.

Abstract: A constraining sheath for use around an endoprosthesis (e.g., a stent device, with or without a graft covering), which may be a balloon expandable endoprosthesis but more preferably is a self-expanding prosthesis. The endoprosthesis is coaxially enclosed within the constraining sheath, which is an outer, disruptable, preferably implantable tubular sheath, preferably made of ePTFE. The constraining sheath and endoprosthesis are preferably mounted together as an assembly on an angioplasty balloon for delivery. Deployment of the endoprosthesis entails inflating the angioplasty balloon to a pressure sufficient to disrupt or break the constraining sheath in a prescribed fashion, thereby allowing a self-expanding endoprosthesis to spontaneously deploy. The constraining sheath of ePTFE may be attached to the endoprosthesis and implanted along with the device, or alternatively attached to the balloon catheter shaft and removed with the balloon catheter.

Abstract: A constraining sheath for use around an endoprosthesis (e.g., a stent device, with or without a graft covering), which may be a balloon expandable endoprosthesis but more preferably is a self-expanding prosthesis. The endoprosthesis is coaxially enclosed within the constraining sheath, which is an outer, disruptable, preferably implantable tubular sheath, preferably made of ePTFE. The constraining sheath and endoprosthesis are preferably mounted together as an assembly on an angioplasty balloon for delivery. Deployment of the endoprosthesis entails inflating the angioplasty balloon to a pressure sufficient to disrupt or break the constraining sheath in a prescribed fashion, thereby allowing a self-expanding endoprosthesis to spontaneously deploy. The constraining sheath of ePTFE may be attached to the endoprosthesis and implanted along with the device, or alternatively attached to the balloon catheter shaft and removed with the balloon catheter.

Abstract: A tubular intraluminal graft in the form of a tubular diametrically adjustable stent having a tubular covering of porous expanded polytetrafluoroethylene which is less than 0.10 mm thick. The covering may be on the exterior surface of the stent, or on the interior surface of the stent, or both. The covering may be affixed to the stent by an adhesive which is preferably fluorinated ethylene propylene.

Abstract: A catheter balloon having a controlled failure mechanism such that release of pressure contained within the balloon occurs in a controlled fashion when a predetermined inflation pressure in excess of normal operating pressure is reached within the balloon. The failure mechanism is the result of incorporating a failure mechanism into at least one end of the balloon, for example, with a controlled amount of attachment of the at least one end to the catheter shaft. This end of the balloon therefore fails at a predetermined pressure with the failure occurring before catastrophic failure of the balloon by rupture between the balloon ends. The controlled failure mechanism allows for non-catastrophic failure such that the balloon remains intact following failure and remains easily withdrawable from the body conduit into which it has been inserted.

Abstract: A web of continuous filaments which are made of at least one semi-crystalline polymeric component covalently bonded as a linear block copolymer with or blended with one or more semi-crystalline or amorphous polymeric components. The filaments are intermingled together to form a porous web of filaments, the filaments having multiple contact points with each other within the web. The filaments are bonded at the contact points without requisite for added adhesive binders, adjuncts or post extrusion melt processing. The web may be bioresorbable. The web may also be provided in forms with relatively high cohesive shear strength. The polymeric components of the filaments exist, at least temporarily, in a homogenous substantially phase miscible uncrystallized state.

Abstract: An intraluminal vascular graft in the form of a tube of porous expanded polytetrafluoroethylene film wherein the porous polytetrafluoroethylene film has a microstructure containing a multiplicity of fibrils oriented substantially parallel to each other. The tube has a wall thickness of less than about 0.25 mm and is made from at least one first layer and at least one second layer of porous polytetrafluoroethylene film, wherein the fibrils of the first and second layers are oriented substantially perpendicular to each other. Preferably the fibrils of the at least one first layer are oriented substantially parallel to the longitudinal axis of the tube and the fibrils of the at least one second layer of porous polytetrafluoroethylene film are oriented substantially circumferential to the tube. The first and second layers may be inner and outer layers respectively, or alternatively their relationship may be reversed.

Abstract: A delivery system for use with intraluminal vascular grafts, allowing for easy delivery, deployment of an intraluminal graft and withdrawal of the delivery system. The system employs a balloon catheter to deploy one end of the graft and uses a separate means to deploy the remainder of the graft. A hollow, bullet-shaped tip is used to enclose the balloon during insertion and withdrawal of the delivery system, wherein the bullet-shaped tip is axially movable to either expose or enclose the balloon.

Abstract: The disclosure relates to a tissue and debris barrier for use in association with implanted joint replacement devices. The barrier comprises a biocompatible membrane that is impermeable to debris. The membrane defines an aperture which is positioned about a component of the joint replacement prosthesis. The periphery of the membrane may be mechanically attached by suturing to adjacent tissue. The barrier permits full motion of the replacement joint while preventing or impeding tissue and debris from migrating to and from bone implant interfaces. The preferred barrier material is porous expanded PTFE with one side having a microstructure that promotes tissue attachment and the opposing side having a microstructure that allows highly efficient filtration of fine particulate debris. The barrier may be a single layer material or may be a composite construction in which two or more layers are bonded together.

Abstract: Balloon catheters having the strength and maximum inflated diameter characteristics of an angioplasty balloon and having the recovery characteristics during deflation of an elastic embolectomy balloon. The balloon catheter can be made in very small sizes and has a lubricious and chemically inert outer surface. The balloon catheter is easy to navigate through tortuous passageways, is capable of rapid inflation and deflation and has high burst strengths. Balloon covers having these same characteristics are also described for use with conventional embolectomy balloons or angioplasty balloons.

Abstract: A carvable implant material for use in surgery and especially in plastic and reconstructive surgery. At least two layers of porous PTFE (polytetrafluoroethylene) sheet material are laminated together by an adhesive placed between the adjacent layers of porous PTFE sheet material. Alternatively, a plurality of discrete pieces of porous PTFE may be adhered together by an adhesive. The presence of the adhesive provides a significant increase in stiffness and hence in carvability beyond that possible in a single layer of porous PTFE without the adhesive. Preferred adhesives are thermoplastic fluoropolymers of lower crystalline melt temperature than PTFE, such as FEP or PFA.

Abstract: A method of making a seamless, thinwall tube of porous polytetrafluoroethylene. The method involves the use of corresponding male and female dies to deform a precursor sheet of porous PTFE which has been restrained about its perimeter. Preferably the porous PTFE sheet is heated to a temperature of less than the crystalline melt temperature during the tube-forming process. The precursor material is preferably a sheet of porous expanded PTFE and more preferably a multiaxially expanded sheet. This precursor material may optionally have been previously exposed to heat above the melt temperature of PTFE. The inventive tube is as thin or thinner than the precursor sheet.

Abstract: An implantable bioabsorbable article for the separation and regeneration of tissue at a tissue defect site in the form of a fibrous matrix laminarly affixed to both surfaces of a cell-barrier sheet material. When implanted it allows ingrowth of tissue into the fibrous matrix side of the material; simultaneously the tissue to be regenerated at the tissue defect site is separated from the ingrowing tissue by the cell-barrier sheet material. A method for making the implantable bioabsorbable article is also described.

Abstract: An intraluminal vascular graft in the form of a tube of porous expanded polytetrafluoroethylene film wherein the porous polytetrafluoroethylene film has a microstructure containing a multiplicity of fibrils oriented substantially parallel to each other. The tube has a wall thickness of less than about 0.25 mm and is made from at least one first layer and at least one second layer of porous polytetrafluoroethylene film, wherein the fibrils of the first and second layers are oriented substantially perpendicular to each other. Preferably the fibrils of the at least one first layer are oriented substantially parallel to the longitudinal axis of the tube and the fibrils of the at least one second layer of porous polytetrafluoroethylene film are oriented substantially circumferential to the tube. The first and second layers may be inner and outer layers respectively, or alternatively their relationship may be reversed.

Abstract: A thin-wall PTFE (polytetrafluoroethylene) tube in the form of a tube of porous expanded PTFE film wherein the porous PTFE film has a microstructure containing a multiplicity of fibrils oriented substantially parallel to each other. The tube has a wall thickness of less than about 0.25 mm and is made from at least one first layer and at least one second layer of porous PTFE film, wherein the fibrils of the first and second layers are oriented substantially perpendicular to each other. Preferably the fibrils of the at least one first layer are oriented substantially parallel to the longitudinal axis of the tube and the fibrils of the at least one second layer of porous PTFE film are oriented substantially circumferential to the tube. The first and second layers may be inner and outer layers respectively, or alternatively their relationship may be reversed.

Abstract: A thin-wall PTFE (polytetrafluoroethylene) tube in the form of a tube of porous expanded PTFE film wherein the porous PTFE film has a microstructure containing a multiplicity of fibrils oriented substantially parallel to each other. The tube has a wall thickness of less than about 0.25 mm and is made from at least one first layer and at least one second layer of porous PTFE film, wherein the fibrils of the first and second layers are oriented substantially perpendicular to each other. Preferably the fibrils of the at least one first layer are oriented substantially parallel to the longitudinal axis of the tube and the fibrils of the at least one second layer of porous PTFE film are oriented substantially circumferential to the tube. The first and second layers may be inner and outer layers respectively, or alternatively their relationship may be reversed.

Abstract: A resorbable implant for interposition arthroplasty which is intended to fill a void between two adjacent bone ends, providing a cushion between the bone ends to prevent impingement of the bone ends while providing time for tissue to infiltrate into the space occupied by the implant. It has a protracted resorption time of preferably at least three months to allow time for the proliferation of load-bearing host fibrous tissue in place of the resorbed implant material. The implant preferably is porous with a pore size of greater than about 80 microns in order to enhance infiltration of fibrous tissue. The implant has a modulus in the range of 0.8 to 20 MPa which is soft enough to allow it to conform to surface irregularities of the adjacent bone surfaces while being hard enough to maintain a desired separation between those bones while tissue infiltration replaces the resorbable implant material.

Abstract: A tubular intraluminal graft for repairing body conduits, made from at least one layer of porous expanded PTFE film that has a microstructure having fibrils oriented in at least two directions which are substantially perpendicular to each other. The tubular intraluminal graft has a wall thickness of less than about 0.25 mm and may have a longitudinally or helically oriented seamline. Additional reinforcing components such as reinforcing ribs or braids may also be provided.

Abstract: A method of securing an intraluminal vascular graft within a living body, the intraluminal vascular graft being in the form of a tube of porous expanded polytetrafluoroethylene film wherein the porous polytetrafluoroethylene film has a microstructure containing a multiplicity of fibrils oriented substantially parallel to each other. The tube has a wall thickness of less than about 0.25 mm and is made from at least one first layer and at least one second layer of porous polytetrafluoroethylene film, wherein the fibrils of the first and second layers are oriented substantially perpendicular to each other. Preferably the fibrils of the at least one first layer are oriented substantially parallel to the longitudinal axis of the tube and the fibrils of the at least one second layer of porous polytetrafluoroethylene film are oriented substantially circumferential to the tube. The first and second layers may be inner and outer layers respectively, or alternatively their relationship may be reversed.

Abstract: A thin-wall PTFE (polytetrafluoroethylene) tube in the form of a tube of porous expanded PTFE film wherein the porous PTFE film has a microstructure containing a multiplicity of fibrils oriented substantially parallel to each other. The tube has a wall thickness of less than about 0.25 mm and is made from at least one first layer and at least one second layer of porous PTFE film, wherein the fibrils of the first and second layers are oriented substantially perpendicular to each other. Preferably the fibrils of the at least one first layer are oriented substantially parallel to the longitudinal axis of the tube and the fibrils of the at least one second layer of porous PTFE film are oriented substantially circumferential to the tube. The first and second layers may be inner and outer layers respectively, or alternatively their relationship may be reversed.