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: The present invention relates to fluid recovery systems for collecting fluid from a patient. A fluid recovery system according to the teachings of the invention includes a housing having a collection chamber for collecting fluid from a patient, and further includes a plurality of components and/or structures that are integrally formed with the housing. Such integrally molded components can include valves for controlling fluid flow within the fluid recovery system and a tamper resistant disposal system.

Abstract: A tunneling device, which is implantable in a body, includes a flexible covering to protect a medical from contamination during the handling and implantation of the device in the body. The tunneling device of the present invention may optionally include a rigid tunneler tip that allows for attachment of the tunneling device to a tunneler instrument prior to the implantation process.

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: A fluid recovery system, such as a chest or thoracic cavity drain, having a collection chamber for collecting fluid from a patient includes a base and a front face having a translucent portion for viewing the collected fluid and monitoring operation of the system. The front face is coupled to the base at an acute angle to facilitate viewing of the collected fluid, and measurement of the fluid volume, from a position substantially above the fluid recovery system. Additionally, a column insert can be positioned within the collection chamber to collect an initial volume of the fluid and to allow precise determination of its volume.

Abstract: A prosthesis is provided that is advantageously used to fill a soft tissue or muscle defect, such as an inquinal or femoral hernia. In a first aspect of the invention, multiple layers of a flexible, mesh material are attach together at a finite number of joins. A tab is placed at the geometric center of one of the mesh layers to facilitate insertion of the mesh into the defect. The tab also creates a blunt tip that reduces irritation and discomfort to the patient. In a second aspect of the invention, a prosthesis is provided that includes a barrier layer between two or more layers of flexible, mesh material to prevent adhesion of the device to the tissue. All layers are attached together by a finite number of joins. A tab is placed at the geometric center of one of the mesh layers to facilitate insertion of the mesh into the defect.

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.

Abstract: A method of forming porous articles with a varying pore distribution by extrusion from a billet with a varying lubricant distribution. A single-polymer polytetrafluoroethylene is extruded and then stretched and sintered to provide a differential porous PTFE structure composed of fibers and nodes connected to one another by these fibers. The microfibrous structure has a portion within the cross-section that possesses a different pore size, accompanied by a different node and fiber geometry, than adjacent areas within that cross section. In a vascular graft, the pores taper inwardly, providing a fluid-tight lumen wall structure that prevents leakage, yet promotes cellular ingrowth and natural tissue regeneration. A node structure of radially-oriented plates provides flexibility, suture strength, and enhanced protection against collapse.

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 with radial zones of differing porosity are described.

Abstract: A method of forming porous articles with a varying pore distribution by extrusion from a billet with a varying lubricant distribution. A single-polymer polytetrafluoroethylene is extruded and then stretched and sintered to provide a differential porous PTFE structure composed of fibers and nodes connected to one another by these fibers. The microfibrous structure has a portion within the cross-section that possesses a different pore size, accompanied by a different node and fiber geometry, than adjacent areas within that cross section. In a vascular graft, the pores taper inwardly, providing a fluid-tight lumen wall structure that prevents leakage, yet promotes cellular ingrowth and natural tissue regeneration. A node structure of radially-oriented plates provides flexibility, suture strength, and enhanced protection against collapse.

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 blood collection device has a modular suction regulator assembly in the form of an adjustable negative pressure relief valve which controls the level of suction in a collection chamber by admitting air to a short bleed-in passage proximate to a suction connection. The modular assembly is a canister which drops into a receptacle oriented transversely in the collection vessel, and defines a laterally-directed intake manifold which resists blockage. The intake passes centrally through the canister along a path spanned by a filter, past a hat-shaped poppet supported on a compression spring. Fluted and threaded members control the scale and range of poppet response so that the assembly may be calibrated before installation. A face plate covers the installed canister, and radial vanes in the intake manifold double as gripping elements for manual adjustment of the assembly. A bellows meter provides refined suction resolution by linearly advancing across an oblique or curved reference line.

Abstract: A prosthetic tissue patch includes a sheet of material having first and second sides, with a plurality of macrochannels extending parallel to each other in the plane of the sheet, and defining a dispersed set of chambers that serves as a reservoir of pharmaceutical material or living culture. The channels communicate through pores in the thin surrounding wall with a surface of the sheet which is placed in contact with tissue and may intergrow therewith. The sheet is preferably 0.2-2.0 mm. thick, with the macrochannels each having a diameter between about 0.1 and 1.5 mm, generally no more than about three quarters of the sheet thickness. A preferred embodiment is formed of polytetrafluoroethylene (PTFE) with an anisotropic porosity structure of nodes which may be oriented generally transverse to the plane of the sheet. The channels are initially filled either by conventional methods, or by insertion of solid filaments of material, and may be capped closed by a special plug.

Abstract: An access controller for a television, computer or display device includes a wireless transmitter and a receiving unit. The receiving unit has a tamper-proof housing that covers the device power line and protects receiving and switching circuitry. The receiving circuitry receives and demodulates a control signal sent by the transmitter, and drives the switching circuitry between ON and OFF states. In a preferred embodiment, the housing has opposed halves which close about the device plug. A pigtail line cord extends from the housing and provides power through the switch, to the device plug. The housing itself is featureless, and the transmitter is an inconspicuous, pocketable, push-button device, so the TV or other device may be controlled without physically approaching or otherwise revealing either the nature of the control mechanism or even that the operator is exercising control.

Abstract: A blood collection vessel includes a blood inlet, a pooling region in which blood from the inlet collects, and an outlet in the pooling region for reinfusion of the collected blood. A filter located in the blood path between inlet and outlet extends at least in part into the pooling region and impounds clots so they remain away from the outlet but suspended in the collected blood. Preferably, the filter is located to provide venting between both sides of the filter. In one embodiment the filter is a vertical wall, which defines a shielded outlet column or chimney extending above the outlet. Blood permeates to the outlet region over a broad area, and the column forms an open suction path that prevents suction differentials from arising across the filter, so clots cannot be sucked through the large-pore material. With the clots residing in the collected fluid, the total fluid loss is directly displayed in a single window at all times, and maximal use is made of the limited volume in the vessel.

Abstract: A thoracic cavity drainage device includes a first vessel having a plurality of chambers one of which is a regulated drainage chamber, and a separate transfer vessel which receives fluid collected in the drainage chamber of the first vessel. The chambers of both vessels are interconnected in a series by fluid passageways which cooperate to maintain a uniform range of suction in the drainage chamber while preventing passage of water into the drainage chamber and permitting a different level of suction in the transfer vessel. This operation is effective despite relatively large pressure and vacuum impulses caused by stripping of drainage lines, patient coughing, and the like, and despite discrete changes in the physical configuration of the system caused by disconnection of the transfer vessel, connection of the transfer vessel to an infusion line or the opening or closing of fluid lines and ports. A novel transfer vessel empties the drainage device and provides gravity reinfusion of the collected fluids.