Abstract: A suture ring for a rotatable artificial heart valve apparatus has a ring member covered by a fabric material. A portion of the fabric material covers a portion of the inner surface of the ring member. At least one protuberance is formed on the inner surface of the ring member so as to mitigate the frictional resistance to rotation which results from compression of the fabric between the suture ring and the heart valve. Thus, desirable rotation of the heart valve relative to the suture ring is assured over a range of thicknesses of the fabric material.

Abstract: An assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line.

Abstract: A biological valvular prosthesis defined by a chemically fixed biological derived conduit having at least one integrally formed tissue valve. The chemical fixation of the valve ensures that the leaflets remain open under normal forward blood flow conditions, but close under minimal backflow pressure. The biological valvular prostheses are useful in the replacement of venous valves and other biological valves. The biological valvular prosthesis may also be in the form of a tubular conduit bearing one tissue valve. This valvular conduit prosthesis is useful for the reconstruction of the pulmonary artery to correct various types of congenital defects.

Abstract: An assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line.

Abstract: A process for purifying Factor VIII:C comprising contacting an immobilized antibody specifically binding a Factor VIII:C with Factor VIII: C, desorbing Factor VIII:C from the antibody which had adsorbed it, eluting Factor VIII:C from the presence of the antibody, passing the eluted Factor VIII:C through an affinity region capable of binding the Factor VIII:C, binding the Factor VIII:C in the affinity region and passing contaminants through said region, and eluting the purified Factor VIII:C.

Abstract: A fully exchangeable integrated-wire dilation catheter for performing angioplasty is disclosed having a flexible small diameter guide wire provided with an enlarged diameter distal end portion and a flexible elongated tubular shaft with at least one dual function fluid conducting lumen adapted to receive the guide wire extending therethrough. The distal end of the tubular shaft is connected to the proximal end of an expandable balloon provided with a coaxially aligned distal orifice having means for releasably engaging the enlarged distal end portion of the guide wire in sealing relationship. In a preferred embodiment the sealing means is a flexible sleeve extending from the distal orifice of the expandable balloon and dimensioned to slidingly engage the correspondingly sized enlarged distal end portion of the guide wire. Associated procedures for utilizing the dilation catheter are also disclosed.

Abstract: A method and device for testing artificial or natural venous valves. The device comprises chamber (10) a sample for mounting a test valve (V) on a liquid flow path and a muscle pump component (16) and/or respiratory pump component (50) and/or capacitance reservoir (58) and/or vertical hydrostatic column component (102) fluidly connected to the flow path to mimic the muscle pump, respiratory pump, capacitance and hydrostatic impedance effects on venous circulation in the mammalian body. Included in the invention are methods of testing venous valves by mimicking known hemodynamic flow conditions within a mammalian body.

Abstract: A fully exchangeable over-the-wire dilatation catheter disclosed having an expandable balloon mounted on the distal end of a flexible, elongate tubular shaft provided with first and second through lumens. The first lumen traverses the longitudinal extent of the tubular shaft and is sealingly connected to the expandable balloon. The second lumen is adapted to slidingly receive a guidewire throughout the longitudinal extent of the tubular shaft and through the interior of the expandable balloon. The tubular shaft is also provided with a longitudinal rip seam extending into the second lumen from the proximal portion of the tubular shaft to a point adjacent the distal end of the tubular shaft. The rip seam may be provided with one or more side access ports into the second guidewire lumen and enables the catheter to be peeled from the guidewire during removal and exchange procedures without the need for docking a guidewire extension.

Abstract: An integrated catheter stripper is mounted within a modified Y-connector that is used to seal a catheter on a guide wire. The connector is provided with a stripping port that opens into the central bore of the main body of the connector. A catheter slitter is mounted over the guide wire within the central bore of the main body for slitting the catheter as the catheter slides in the proximal direction along the guide wire within the main body. The split catheter is removed through the stripping port, which can be sealed during an angioplasty operation when the catheter is in use.In non-integrated embodiments of the invention the catheter stripper is separate from the Y-connector and has a main body, a blade mounted in the main body, and an arrangement for aligning the catheter with the blade and for permitting mounting and separation of the blade relative to the catheter only by substantially longitudinal movement.

Abstract: An assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line.

Abstract: An extendable guidewire system including a guidewire and extension wire bearing separate helical coil connectors. The coil connectors, at least in part, have spatially separate adjacent coil turns, thereby providing gaps for receiving coil turns of the other connector.

Abstract: A method and device for testing artificial or natural venous valves. The device comprises (a) a fixture for mounting a sample valve on a liquid flow path, (b) a muscle pump component and/or (o) respiratory pump component and/or (d) capacitance reservoir component and/or (e) vertical hydrostatic column component, all of the components being fluidly connected to the flow path to mimic the muscle pump, respiratory pump, capacitance and hydrostatic impedance effects of actual in situ venous circulation in the mammalian body. The invention includes methods of testing venous valves by mimicking known hemodynamic flow conditions within a mammalian body.

Abstract: A catheter for measuring the temperature of a fluid in a living body comprising an elongated tube having at least one lumen extending longitudinally within the tube and an opening in a peripheral wall of the tube. A thermistor mounting body mounts a thermistor in the lumen adjacent the opening. The thermistor mounting body defines a cavity at the opening which opens radially outwardly, and the thermistor is partially within the mounting body and projects from the mounting body into the cavity. There is at least one conductor in the tube with at least a region of the conductor being in the lumen and extending along the lumen to the thermistor. The region of the conductor is electrically coupled to the thermistor. The region of the conductor extends longitudinally of the lumen from a location in the lumen proximally of the thermistor to a location at which the conductor is electrically coupled to the thermistor.

Abstract: A process for the preparation of implantable biological tissue, and in particular bioprosthetic heart valves, which are prone to calcification after implantation. The process includes the treatment of tissue with an effective amount of a surfactant to reduce calcification of the implanted tissue.

Abstract: An apparatus for determining fluid pressure and inflation diameter in the balloon of a dilation catheter includes a pressure sensing transducer in fluid communication with the interior of the catheter balloon. The transducer provides a balloon pressure signal which is processed by a microcomputer to determine a balloon diameter or circumference as a function of the balloon pressure. The microcomputer produces a signal representing the balloon diameter or circumference. A digital display responds to the pressure signal and diameter signal to display both balloon pressure and diameter in order to provide an added degree of safety and control to a vascular physician conducting balloon angioplasty or similar procedures.

Abstract: A catheter system includes a guide wire, a working catheter and a torque device for removably coupling the working catheter to the guide wire while enabling rotation of the guide wire to the working catheter. Advancement of the guide wire in a vascular system is enabled by rotating the guide wire while the working catheter is coupled thereto. A procedure for use of the catheter system includes the simultaneous insertion of the guide wire and working catheter into a vascular system and independent rotation of the guide wire for steering the guide wire, with working catheter coupled thereto, through the vascular system.

Abstract: Interpenetrated matrix of polytetrafluoroethylene and elastomer is disclosed. The matrix is formed into a composite material which is flexible, durable, highly porous with a tight microporous structure and improved retractability. The composite material is subjected to a multi-expansion process to produce shaped articles such as films, tubes, rods and filaments with excellent flexibility and elasticity. More particularly, the composite material can be utilized to produce vascular grafts with excellent biological compatibility.

Abstract: The present invention provides conformable intralumen electrodes for use with medical catheters. The electrodes are made of a conductive polymeric material that is introduced into the lumen of a catheter through an opening cut in the peripheral wall in the catheter. A conductive lead threaded through the lumen of the catheter terminates in a distal end at the opening in the catheter and is completely embedded within the polymeric material introduced into the opening, thereby establishing electrical contact between the conductive polymeric electrode and the conductive lead. The conductive polymeric material fills the opening adhering to the walls of the catheter tube, thereby ensuring secure, long lasting attachment.

Abstract: An apparatus comprising a connector body, an optical fiber mounted on the connector body and a receptacle having a cavity for receiving the connector body. The connector body has a cam surface, and the receptacle cooperates with the cam surface when the receptacle and connector body are appropriately positioned to urge the connector body farther into the cavity to place optical portions of the connector body and the receptacle into substantial engagement.