Abstract: A system for forming a polymeric body includes a non-perforated irrigating shaped form, such as a catheter balloon, fluidly coupled with a container storing a first component. The irrigating shaped form is sized and dimensioned for positioning within a patient's body. A second component is disposed at the irrigating shaped form. The second component can either be supplied separately to the irrigating shaped form, pre-exist within the irrigating shaped form, exist as a coating or other residual element on the irrigating shaped form, or the like. In a corresponding method, a first component reacts with the second component upon delivery of the first component from the first component container through the irrigating shaped form. The reaction of the components forms a compound emitted from the irrigating shaped form to a targeted location within the patient's body. The compound cures to form the polymeric body.

Abstract: The invention is directed to methods involving rewetting of expandable polymers with a wettable liquid to allow for enhanced expansion at or below room temperature without breakage, and in some cases, allows one to achieve a greater expansion ratio than that allowed at elevated temperatures using known methods. The wettable liquid can be formed of a drug and/or an agent, such that the resulting polymer contains and emits the drug upon positioning at a target location of a patient body. The expandable polymer can also have the drug or agent added to its structure at a polymer resin preparation stage, through use of an aqueous solution mixed with one or more fluoropolymers, or in a mixing stage. The present invention also allows one to achieve material with unique properties and handling characteristics. These properties included decreased material thickness, increased density, an altered node/fibril morphology, and a more consistent web in the case of flat material.

Abstract: The invention is directed to methods for fabricating devices from polymer precursors, along with devices so fabricated. The methods of the invention include the steps of plasma treating a polymer based resin, paste, preform billet, or extrudate, and employing the treated polymer in the fabricated device. According to one embodiment, the fabricated device can include implantable prosthetics such as heart valves, sutures, vascular access devices, vascular grafts, shunts, catheters, single layered membranes, double layered membranes, and the like. Devices fabricated according to one embodiment of the invention include regions having selected porosity, permeability and/or chemistry characteristics.

Abstract: The invention is directed to methods involving rewetting of expandable polymers with a wettable liquid to allow for enhanced expansion at or below room temperature without breakage, and in some cases, allows one to achieve a greater expansion ratio than that allowed at elevated temperatures using known methods. The present invention also allows one to achieve material with unique properties and handling characteristics. These properties included decreased material thickness, increased density, an altered node/fibril morphology, and a more consistent web in the case of flat material. This method is not limited to room temperature conditions and can be applied whenever the expandable polymer material is wet with a wettable liquid, and the expansion is performed at a temperature preferably below the vaporization or boiling points of that liquid.

Abstract: An implantable medical device having a removable polymeric drug delivery panel electrostatically coupled to a surface of a radially expandable structure is provided. The removable polymeric drug delivery panel provides a microporous structure suitable for embedding one or more bioactive agents to allow for kinetic release of the agent or agents at a desired location within a hollow fluid body organ. The removable polymeric drug delivery panel is characterized as having a relatively large and flat surface area to allow for extended or high volumes of kinetic release potential at the site.

Abstract: The invention is directed to methods for fabricating devices from polymer precursors, along with devices so fabricated. The methods of the invention include the steps of plasma treating a polymer based resin, paste, preform billet, or extrudate, and employing the treated polymer in the fabricated device. According to one embodiment, the fabricated device can include implantable prosthetics such as heart valves, sutures, vascular access devices, vascular grafts, shunts, catheters, single layered membranes, double layered membranes, and the like. Devices fabricated according to one embodiment of the invention include regions having selected porosity, permeability and/or chemistry characteristics.

Abstract: A graft has a seamless flow dividing structure. A method of manufacturing the flow dividing graft structure includes providing a first section of graft material having at least one side, a first end, and a second end. An opening is drawn out through the at least one side. A second section of graft material is coupled with the opening. An angled section is formed along the first section of graft material. The angled section provides a seamless division of flow supplied from the second section to the first section and directs the flow to each of the first and second ends of the first graft material. The resulting graft structure includes a main graft section. A branch graft section is coupled with the main graft section at an angled divider section. The angled divider section is seamless and is suitable for dividing flow through the flow dividing graft structure.

Abstract: The invention is directed to methods for fabricating devices from polymer precursors, along with devices so fabricated. The methods of the invention include the steps of plasma treating a polymer based resin, paste, preform billet, or extrudate, and employing the treated polymer in the fabricated device. According to one embodiment, the fabricated device can include implantable prosthetics such as heart valves, sutures, vascular access devices, vascular grafts, shunts, catheters, single layered membranes, double layered membranes, and the like. Devices fabricated according to one embodiment of the invention include regions having selected porosity, permeability and/or chemistry characteristics.

Abstract: An apparatus for establishing a re-usable, recurring, mechanical connection to an organ within a patient is provided. A body fluid cartridge exchange platform device includes a hollow cartridge platform housing with a first end having an opening. The platform housing can additionally have a second end with a second opening. The first opening and the second opening facilitate insertion of an exchange cartridge insert that sealably engages the housing. The first opening and the second opening additionally facilitate removal of the exchange cartridge insert. The exchange cartridge insert can facilitate a flow path between a first leg and a second leg of the platform housing, and can facilitate a flow path between the platform housing and an external location for medical procedure or drug delivery purposes.

Abstract: The invention is directed to methods involving rewetting of expandable polymers with a wettable liquid to allow for enhanced expansion at or below room temperature without breakage, and in some cases, allows one to achieve a greater expansion ratio than that allowed at elevated temperatures using known methods. The wettable liquid can be formed of a drug and/or an agent, such that the resulting polymer contains and emits the drug upon positioning at a target location of a patient body. The present invention also allows one to achieve material with unique properties and handling characteristics. These properties included decreased material thickness, increased density, an altered node/fibril morphology, and a more consistent web in the case of flat material.

Abstract: A radially expandable device having a body constructed of a generally inelastic, expanded fluoropolymer material is described. The body is deployable upon application of a radial expansion force from a reduced diameter, collapsed configuration to an expanded configuration having a pre-defined and fixed increased diameter. The body has a singular, unitary construction of generally homogenous material that is characterized by a seamless construction of expanded fluoropolymer material, such as expanded polytetrafluoroethylene (ePTFE), and is preferably constructed through an extrusion and expansion process. The body is further characterized by a microstructure of nodes interconnected by fibrils in which substantially all the nodes of the body are oriented generally perpendicularly to the longitudinal axis of the body.

Abstract: A vascular endoprosthesis is formed of a tubular liner preform with a continuous surface and having a diameter smaller than that of an intended vessel. The liner is inserted to a treatment site, and its sheet material undergoes a radially-directed expansion to a final size that fits the vessel. Insertion and in situ expansion are achieved using a catheter assembly in which either an internal stent, such as a stiff-filament helically woven tube, or an inflatable balloon urge the liner preform outwardly against the inner wall of the vessel. The stent, or one or more simple internal snap-rings anchor the expanded liner in place. The expanded liner is porous, or becomes more porous during expansion, and one or more aspects of its porosity are tailored to the intended treatment goal of immobilizing treatment material, isolating cells, or permitting controlled permeation of selected materials.

Abstract: A porous tube suitable for use as a vascular graft prosthesis and a method of making it is disclosed. It has a structure of porous polytetrafluoroethylene having a fibrous structure of nodes and fibers connecting the nodes together and an integrated intrawall circumferential support adjacent to areas of variable porosity. This invention provides a polytetrafluoroethylene polymer in a porous form useful as artificial internal organs for, for example vascular bypass, vascular access, and endovascular prosthesis. PTFE walls are found with radial zones of differing porosity are described.

Abstract: A method of making a radially expandable device having a body constructed of a generally inelastic, expanded fluoropolymer material. The body is deployable upon application of a radial expansion force from a reduced diameter, collapsed configuration to an expanded configuration having a pre-defined and fixed increased diameter. The body has a singular, unitary construction of generally homogenous material that is characterized by a seamless construction of expanded fluoropolymer material, such as expanded polytetrafluoroethylene (ePTFE), and is preferably constructed through an extrusion and expansion process. The body is further characterized by a microstructure of nodes interconnected by fibrils in which substantially all the nodes of the body are oriented generally perpendicularly to the longitudinal axis of the body.

Abstract: A radially expandable device having a body constructed of a generally inelastic, expanded fluoropolymer material is described. The body is deployable upon application of a radial expansion force from a reduced diameter, collapsed configuration to an expanded configuration having a pre-defined and fixed increased diameter. The body has a singular, unitary construction of generally homogenous material that is characterized by a seamless construction of expanded fluoropolymer material, such as expanded polytetrafluoroethylene (ePTFE), and is preferably constructed through an extrusion and expansion process. The body is further characterized by a microstructure of nodes interconnected by fibrils in which substantially all the nodes of the body are oriented generally perpendicularly to the longitudinal axis of the body.

Abstract: A prosthesis and a method of making a prosthesis having a needle containment and support structure that minimizes needle point plowing and/or needle scoring and inhibits delamination of the support structure during cannulization of the prosthesis. The prosthesis includes a first tube of expanded polytetrafluoroethylene (ePTFE), a polymer membrane, preferably ePTFE, positioned about the exterior surface of the first tube, and at least one support structure wound along a winding axis about the membrane to form axially spaced-apart ridges on the membrane. The support structure is a bead, filament, or similar structure that is wound about the exterior surface in a helical or spiral pattern to form the spaced apart-ridges. Alternatively, a plurality of spaced support rings can be employed to form the ridges. The ridges are preferably spaced apart a distance effective to direct a needle to a puncture site at an angle that inhibits needle plowing and hole enlarging, approximately less than 1.

Abstract: A porous tube suitable for use as a vascular graft prosthesis and a method of making it is disclosed. It has a structure of porous polytetrafluoroethylene having a fibrous structure of nodes and fibers connecting the nodes together and an integrated intrawall circumferential support adjacent to areas of variable porosity. This invention provides a polytetrafluoroethylene polymer in a porous form useful as artificial internal organs for, for example vascular bypass, vascular access, and endovascular prosthesis. PTFE walls are found with radial zones of differing porosity are described.

Abstract: A radially expandable support body is enveloped within a cocoon. In a preferred construction, the support is a stent, and a tube of polymeric material, e.g., polytetraeluoroethylene (PTFE), passes through the interior of the stent body and is turned back upon itself over the stent to form a cuff. The assembly is then heated and the outer layer contacts and coalesces with the inner layer, closely surrounding the stent body within a folded envelope having a continuous and seamless end. In one embodiment, an end portion of the tube is expanded before folding back over the-stent. The end portion, which becomes an exterior surface of the finished product, thus acquires a greater degree of porosity. Each end of the central tube may be so expanded, and folded back to seal all surfaces and both ends. The stent body itself may be a ring, or a short series of spaced-apart rings, or a wire or web, or a sheet possessing a number of apertures extending entirely through the sheet.

Abstract: The wall of a prosthesis has a region which modulates communication through the porosity of the wall. The prosthesis is unitary, but may be assembled in successive bodies which are coalesced, so that the porous microstructure changes distinctly at stages through the thickness dimension of the wall. One embodiment is formed entirely of fluoropolymer, and has at least one surface adapted to support tissue regeneration and ingrowth. The modulation region is a stratum of high water entry pressure that reduces pulsatile hydraulic pressure transmission, or locally alters fluid-born-distribution of biological material through the wall and allows more natural gradients for tissue regeneration and growth in the outer region of the wall.

Abstract: A radially expandable support body is enveloped within a cocoon. In a preferred construction, the support is a stent, and a tube of polymeric material, e.g. polytetrafluoroethylene (PTFE), passes through the interior of the stent body and is turned back upon itself over the stent to form a cuff. The assembly is then heated and the outer layer contacts and coalesces with the inner layer, closely surrounding the stent body within a folded envelope having a continuous and seamless end. In one embodiment, an end portion of the tube is expanded before folding back over the stent. The end portion, which becomes an exterior surface of the finished product, thus acquires a greater degree of porosity. Each end of the central tube may be so expanded, and folded back to seal all surfaces and both ends. The stent body itself may be a ring, or a short series of spaced-apart rings, or a wire or web, or a sheet possessing a number of apertures extending entirely through the sheet.