Abstract: A process for producing a shaped porous article includes the steps of providing an extrudate of a fluoropolymer material which is capable of being stretched and bilaterally stretching the extrudate along a longitudinal axis. The stretching step is carried out under conditions sufficient to yield an article which is substantially uniformly stretched over a major portion of its length. After stretching, the material has a unique through-pore microstructure characterized by elongate nodes connected by fibrils. The stretched material is sintered while being maintained in its stretched state to produce the shaped porous article. A significant feature of the inventive process is that stretching is carried out by displacing both ends of the extruded material as opposed to known method wherein only one end of an extruded material is stretched, resulting in a microporous fluoropolymer article which are different than conventional fluoropolymer stretching/expansion processes.

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: An implantable prosthetic device for sustained release of a bioactive material into a fluid flow pathway of a patient comprises a body adapted for attachment to the fluid flow pathway. The body defines a primary lumen for accommodating fluid flow therethrough and at least one secondary lumen at least a portion of which is separated from the primary lumen by a wall sufficiently permeable to permit a bioactive material disposed in the lumen to diffuse through the wall and into the primary lumen. The bioactive material can be either a therapeutic or diagnostic agent. In a particular embodiment of the invention, the device comprises a tubular body consisting of stretched and/or expanded polytetrafluoroethylene and is adapted for attachment to a blood vessel of a patient.

Abstract: A fluid collection vessel for drainage of body fluids includes a molded body with internal dividers constituting ports, baffles and subchambers, and a face plate that closes the body to form a suction-regulated multi-chamber vessel. The vessel has overpressure and underpressure protection, and cannot lose its fluid when tipped. The molded body incorporates novel valves and ports, and a wall structure enhances its utility for blood collection and monitoring. Dynamic fluid level is stabilized by diversion of fluid energy into a side chamber in the downstream region of the manometer column.

Abstract: A collection vessel for drainage of body fluids includes a molded body with internal dividers constituting ports, baffles and subchambers, and a face plate that closes the body to form a suction-regulated multi-chamber vessel. The vessel has overpressure and underpressure protection, and resists tipping. The molded body includes a wall structure that enhances its utility for blood collection, monitoring, and reinfusion, and incorporates novel valves, ports, handle and stand.

Abstract: Apparatus for blood collection includes a collection bag with a suction inlet, a fluid inlet, and an outlet, and an internal stent that resiliently biases the bag into a fixed shape while moving to modulate abrupt variations in suction level. A gross filter about the outlet is located out of the suction path, eliminating blood damage from drying or cell trauma. Different graduation scales show the true volume of collected fluid under suction conditions during collection and with no suction during reinfusion. Two quick-connects allow in-line connection with a chest drain to provide suction, and mate with each other to close the inlets when the filtered bag is removed for gravity reinfusion. When multiple units are piggy-backed, they fill sequentially and may be removed for reinfusion quickly, with only a single tube reconnection required during surgery.

Abstract: A polylumenal implantable device comprises a body defining a plurality of capillary lumina. The prosthetic device is suitable for implantation in a patient as an arterial or venous bypass graft or shunt, or intra-organ implant as well as other purposes. The improved prosthetic device has increased surface area and preferably a three-dimensional porosity for encouraging the harboring of, for example, endothelial cells, as well as for receiving organized deposition of material such as genetically enhanced cell types. A method for providing a bioactive material to a patient includes the steps of providing a polyluminal implantable organ comprising an implantable body defining a plurality of capillary lumina, treating the interior surfaces of the lumina with a bioactive material or plasma polymerization, and implanting the prosthetic device in the patient so that bodily fluids of the patient come into contact with the treated interior surfaces.

Abstract: An implantable prosthetic device comprises a remotely detectible component disposed in the body forming the device for allowing the device to be detected by x-ray, ultrasonic, or MRI imaging. By disposing at least two remotely detectible components in the body of the device, the effective flow diameter provided by the device can be monitored. A method for monitoring a patient having a damaged or dysfunctional vascular pathway includes the steps of implanting in the patient the disclosed prosthetic device and monitoring the patency of the device by x-ray, ultrasonic, MRI, or other form of remote imaging.

Abstract: A multipurpose collection vessel includes a closed vessel with suction-regulating and chamber isolating components, and a collection chamber for receiving blood through a tube connected to a wand or surgical drain. The collection chamber is split into a filtered reinfusion chamber with volumetric graduations of several milliliters over a two hundred milliliter range, and a separate unfiltered chamber, for a combined volume of several liters. The collection vessel may perform all conventional functions of a pediatric drain, reinfusion vessel, cardiotomy bucket, general wound drainage device, or multi-site drainage device. This simplifies hospital inventory requirements and reduces the need for device-specific training of hospital ward personnel.

Abstract: A vascular prosthesis has a plurality of tubular structures, each of which is manually separable from the others. Each tube structure has a biocompatible exterior surface and a lumen of predetermine diameter. Fluid, such as blood, is channelled through the lumina upon implantation in an arterial or venous pathway. Each of the tube structures is separable from the others over at least a portion of the axial extent of the exterior surface.

Abstract: An implantable self-sealing vascular graft device comprises an implantable tubular body defining a primary lumen and at least one secondary lumen, the lumina sharing a common side wall. The primary lumen is adapted for attachment to the vascular system of the patient to accommodate blood flow therethrough. A non-biodegradable elastomeric material disposed in the secondary lumen permits repeated self-sealing penetrations of a cannula through the elastomeric material and into the primary lumen. A method for repeatedly accessing a patient's vascular system by implanting in the patient the disclosed structure and accessing a patient's vascular system by passing a cannula through the secondary lumen, the common side wall, and into the primary lumen is also disclosed.

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.

Abstract: A drainage device includes a vessel having a plurality of sub-chambers one of which is a regulated drainage collection chamber, and two of which cooperate to maintain a selected suction level in the drainage collection chamber. A stopcock proximate to the vessel communicates directly with the two cooperating sub-chambers, and allows quick adjustment and stable operation in varying environments. A float ball arrangement provides an indication of water loss that may compromise the water seal. The device is suitable for wound drainage, and may be used as a cardiotomy reservoir or a thoracic cavity drain device. Different embodiments collect blood for autologous infusion.

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.

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.

Abstract: Disclosed are the product and method for making a macroscopically smooth, microporous, flexible, elastic tubular prosthetic device from a substantially non-elastic woven fabric tube. The method involves axially compressing the substantially non-elastic tube on a tight fitting cylindrical mandrel so that the individual axially oriented threads of the fabric form loops projecting radially outwardly between circumferential threads. The threads are set to return to this loop configuration upon release of tension applied axially to the tube. The exterior of the tube presents an easily deformed, macroscopically smooth surface having a multiplicity of interstices among the threads and among the fibers of the threads into which cells can grow after implantation.