Abstract: The present invention is directed to implantable medical device assemblies. The assemblies are primarily used to introduce and deposit implantable medical devices in the vasculatures of implant recipients. The principle implantable medical device used in the assembly is an expandable element in the form of an endovascular device. The expandable element is maintained in a compacted configuration during introduction of the device into the vasculature with a confinement means. The expandable element is released from the confinement means at an implantation site with a control line. The control line has high tensile strength, high modulus, structural rigidity, and low compressibility. These features of the control line provide a practitioner with tactile feedback of the release of the expandable element from the confinement means. The tactile feedback is present during the entire deployment of the expandable element.

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: The present invention is directed to implantable medical device assemblies. The assemblies are primarily used to introduce and deposit implantable medical devices in the vasculatures of implant recipients. The principle implantable medical device used in the assembly is an expandable element in the form of an endovascular device. The expandable element is maintained in a compacted configuration during introduction of the device into the vasculature with a confinement means. The expandable element is released from the confinement means at an implantation site with a control line. The control line has high tensile strength, high modulus, structural rigidity, and low compressibility. These features of the control line provide a practitioner with tactile feedback of the release of the expandable element from the confinement means. The tactile feedback is present during the entire deployment of the expandable element.

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 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: 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: 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: 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 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.

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 tube of porous PTFE having at least two first and at least two second regions wherein the at least two first regions have a greater density than the at least two second regions. For tubes of porous expanded PTFE having a microstructure of nodes interconnected by fibrils, the at least two first regions have a mean fibril length that is less than that of the at least two second regions. Preferably the regions are arranged in the form of ring-shaped segments of the tube wherein denser segments alternate along the length of the tube with less dense segments. Other arrangements between the different regions are possible; for example, the regions may be oriented in a spiral relationship with each other along the length of the tube. The porous PTFE tubes of the present invention have excellent radial compression resistance without requiring additional exterior reinforcing members due to the presence of the denser regions that are provided with a circumferential orientation.

Abstract: A tube which circumferentially distends from its initial circumference upon the application of a circumferentially distending force such as applied by an internal pressure, and which exhibits minimal recoil following the removal of the circumferentially distending force. The tube preferably has a second circumference larger than the initial circumference which remains substantially unchanged by further increasing force once it has been achieved. Because of the distensible circumference and minimal recoil of the tube, the tube is useful as a liner for pipes and vessels and particularly for pipes and vessels having irregular internal surfaces to which the tube can smoothly conform. The tube is preferably made from porous PTFE with thin walls, in which form it is particularly useful as a liner for both living and prosthetic blood vessels and to line anastomoses between living and prosthetic blood vessels.

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 lubricous 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 tube of porous PTFE having at least two first and at least two second regions wherein the at least two first regions have a greater density than the at least two second regions. For tubes of porous expanded PTFE having a microstructure of nodes interconnected by fibrils, the at least two first regions have a mean fibril length that is less than that of the at least two second regions. Preferably the regions are arranged in the form of ring-shaped segments of the tube wherein denser segments alternate along the length of the tube with less dense segments. Other arrangements between the different regions are possible; for example, the regions may be oriented in a spiral relationship with each other along the length of the tube. The porous PTFE tubes of the present invention have excellent radial compression resistance without requiring additional exterior reinforcing members due to the presence of the denser regions that are provided with a circumferential orientation.

Abstract: A vascular graft in the form of a tube or flat sheet of biocompatible material having an outer covering of deflectably secured material such as porous film, fibers, discrete pieces of material, or combinations thereof. Two different types of fibers may also be used. The vascular graft may be of tubular form for replacing or bypassing entire segments of veins or arteries or alternatively may be in the form of a flat sheet useful for repairing portions of the circumference of veins or arteries. The tube or flat sheet of biocompatible material and the outer covering of deflectably secured material are preferably of porous polytetrafluoroethylene. The inventive vascular graft is useful for dialysis access in that it offers a reduction in blood leakage when the vascular graft is punctured by a dialysis needle and the needle is subsequently removed. It is also useful for reducing suture hole bleeding resulting from holes created through the graft by penetration of the graft with a suture needle.

Abstract: A vascular graft in the form of a tube or flat sheet of biocompatible material having an outer covering of deflectably secured material such as porous film, fibers, discrete pieces of material, or combinations thereof. Two different types of fibers may also be used. The vascular graft may be of tubular form for replacing or bypassing entire segments of veins or arteries or alternatively may be in the form of a flat sheet useful for repairing portions of the circumference of veins or arteries. The tube or flat sheet of biocompatible material and the outer covering of deflectably secured material are preferably of porous polytetrafluoroethylene. The inventive vascular graft is useful for dialysis access in that it offers a reduction in blood leakage when the vascular graft is punctured by a dialysis needle and the needle is subsequently removed. It is also useful for reducing suture hole bleeding resulting from holes created through the graft by penetration of the graft with a suture needle.