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 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. 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 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 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 method of making a left ventricular assist device (LVAD) using muscle wrapped around a mandrel to form a muscle pouch, the open end of which is sewn to a circular sheet of patch material having connections to one end of each of a pair of vascular grafts, or alternatively to one end of a single vascular graft. The second ends of these vascular grafts are used to connect the LVAD to the aorta. After the muscle pouch has been formed around the mandrel, the mandrel is removed and replaced by a balloon which is inserted into the muscle pouch and inflated to maintain the desired shape of the muscle pouch during healing and stimulation of the pouch. The balloon is subsequently removed preceding activation of the LVAD to allow it to begin pumping blood. In an alternative embodiment, an additional strip of latissimus dorsi or other appropriate muscle or a mechanical clamping device may be used to synchronously compress the aorta between the ends of the vascular grafts anastomosed to the aorta.

Abstract: A high strength, porous PTFE sheet material having high strength in all directions within the plane of the sheet material. The sheet material has, within the plane of the sheet, a higher minimum tensile strength, matrix tensile strength, secant modulus and matrix secant modulus than previously known porous PTFE sheet materials. The sheet material is a laminate of multiple layers of porous PTFE film, preferably uniaxially expanded film, wherein the orientation of the direction of the fibrils of any layer varies slightly, such as about ten degrees, from the orientation of the fibrils of the adjacent layer. The sheet material is particularly useful as a surgical repair patch and especially as a blood vessel repair patch because of its high strength, flexibility, biocompatibility and very low rate of suture line bleeding.

Abstract: A high strength, porous PTFE sheet material having high strength in all directions within the plane of the sheet material. The sheet material has, within the plane of the sheet, a higher minimum tensile strength, matrix tensile strength, secant modulus and matrix secant modulus than previously known porous PTFE sheet materials. The sheet material is a laminate of multiple layers of porous PTFE film, preferably uniaxially expanded film, wherein the orientation of the direction of the fibrils of any layer varies slightly, such as about ten degrees, from the orientation of the fibrils of the adjacent layer. The sheet material is particularly useful as a surgical repair patch and especially as a blood vessel repair patch because of its high strength, flexibility, biocompatibility and very low rate of suture line bleeding.

Abstract: A method of making a mechanical cable having a steel wire core, a layer of fluoropolymer adhesive covering the steel wire core, and an outer layer of porous PTFE covering the layer of fluoropolymer adhesive. The mechanical cable may be a component of a mechanical cable system wherein the mechanical cable slides axially or rotates within a surrounding support tube. The support tube preferably has an inner surface comprised of non-porous PTFE. The support tube may optionally incorporate a contamination seal at the ends of the support tube to reduce the entrance of contaminating dirt and water into the system. The layer of porous PTFE covering the steel wire core may optionally be filled with a lubricating and abrasion resistant filler such as graphite.

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 sheet of implantable patch tissue repair material having the form of a layer of porous polytetrafluoroethylene sheet material laminated to a layer of mesh-type sheet material having a multiplicity of openings through the mesh-type sheet material, said openings having a mean minimum diameter of about 0.1 mm. The inventive patch tissue repair material offers good strength characteristics, good biocompatibility, suture retention, and flexibility.

Abstract: An implantable electrode in the form a helically wound conductor having an electrically conductive polymeric layer coaxially surrounding and contacting the helically wound conductor, wherein the electrically conductive polymeric layer is electrically conductive in a dry state prior to implantation. Preferably, the electrode has two conductive portions, the additional second conductive portion being preferably located at the distal tip. The implantable electrode preferably incorporates an insulating portion wherein an additional length of the helically wound conductor is continuous with the remaining length of helically wound conductor coaxially covered by the electrically conductive polymeric layer. The insulating portion has a coaxial covering of impermeable polymeric electrically insulating material which is preferably silicone tubing.

Abstract: A surgical tool for use in preparing a graft path in anterior cruciate ligament reconstruction in a knee joint in which aligned tibial and femoral osseous tunnels are made for a bone-tendon-bone graft or similar surgery where two bone tunnels are in alignment. The tool comprises an elongated guide body having a guide shaft capable of being positioned within the tibial tunnel and extending into the femoral tunnel, and an elongated channel-like main body which is coaxial with the guide shaft. The main body includes a rasping head and is rotatably and axially slidable on the guide shaft for guided rasping of bone surfaces along the graft path. The rasp head fully encircles the guide shaft and is capable of following the guide shaft to enter and extend beyond the tibial tunnel. The leading end of the guide body includes a guide head with a flexible structure for connecting the head to the guide shaft.

Abstract: A suture needle holder for a suture package intended to contain an armed suture, comprising a sheet of planar plastic having at least one raised pedestal formed therein, said at least one raised pedestal having at least one slot therein oriented orthogonal to the sheet of planar plastic, said at least one slot having an open portion and a needle-holding portion releasably holding a portion of the length of a suture needle therein with the length of the suture needle lying in a plane parallel to the sheet of planar plastic, wherein the open portion of the slot is of a width narrower than the diameter of the length portion of the suture needle held within the needle-holding portion of the slot. A method of forming the suture needle holder is also described.

Abstract: A flexible catheter is provided for use with an antenna which radiates high-frequency or microwave energy, the catheter having a carrier tube and an outer layer of microporous polytetrafluoroethylene on the outer circumference of the carrier tube.

Abstract: An implantable lead for use with cardiac pacemakers, defibrillators and other long term implantable electrical devices intended for sensing or tissue stimulation, having a helically wound conductor with a surrounding tubular insulating layer of elastomeric material such as silicone or polyurethane and an additional coaxial tubular exterior biocompatible layer of porous PTFE having a microstructure of nodes interconnected by fibrils. The exterior tubular layer of porous PTFE may be fitted coaxially over the elastomeric tubular layer whereby the porous PTFE tubular layer is in longitudinal compression and the fibrils within the microstructure have a bent and wavy appearance. Any portion of the length of the porous PTFE tubing in longitudinal compression allows that portion of the length of the lead wire to be extensible to a controlled extent limited by the straightening of the bent fibrils within the porous PTFE microstructure.

Abstract: A suture needle having, in sequence, a shaft portion, a tip portion, a conical point portion and a point. The shaft portion may be straight or curved, and cylindrical or tapered. The tip portion has at least two substantially flat surfaces. The conical point portion is of conical shape having a substantially round cross section adjacent to the point of the needle. A plane tangent to the surface of the conical point portion makes a greater angle with respect to the longitudinal centerline of the needle than does the angle formed by the intersection of a plane through a flat surface of the tip portion and the longitudinal centerline of the needle.

Abstract: An implantable porous expanded polytetrafluoroethylene material having a microstructure of nodes interconnected by fibrils wherein a surface of the material has been modified by the removal of fibrils from the surface so that under magnification the surface has the appearance of freestanding node portions not interconnected by fibrils but rather having open valleys disposed between the freestanding node portions. Unmodified material beneath the surface maintains the original microstructure of nodes interconnected by fibrils. The modification is preferably done by exposing the surface to radio frequency gas plasma discharge with a reactive etching gas for a lengthy amount of time such as about ten minutes. The depth of fibril removal from the surface is substantially a function of the duration and amount of energy applied to the surface.

Abstract: Porous expanded polytetrafluoroethylene material having a microstructure of nodes interconnected by fibrils wherein a surface of the material has been modified to have increased hydrophobicity as indicated by having a water droplet roll-off angle of less than about 10 degrees in comparison to a typical roll-off angle of greater than about 12 degrees for the unmodified material. Under magnification, the surface morphology may be indistinguishable from that of the unmodified precursor material. The modification is preferably done by exposing the surface to radio frequency gas plasma discharge with a reactive etching gas for a lengthy amount of time such as about ten minutes. If surface etching is continued beyond a time adequate to produce the highly hydrophobic behavior, then the surface morphology includes the appearance of broken fibrils.