Abstract: An improved set of stents for autologous tissue heart valves is provided. The stents are designed with the aid of a computer-aided-design (CAD) system, and nest within each other to securely clamp a piece of tissue which forms the leaflets of the heart valve. The geometrical features of the stents are designed to provide uniform nesting between the stents to prevent the formation of stress raisers on the tissue. Additionally, the windows in the stent posts are narrowed to prevent the suturing needle used during implantation of the valve from becoming lodged in the garter springs which clamp the outer stent to the inner stent. Finally, the sock covering the outer stent is bonded to the stent base at both upper and lower locations to isolate the bonds from the patient's blood flow.

Abstract: A method of manufacturing and testing a tissue heart valve during open heart surgery is disclosed. A piece of autologous tissue from the body of the patient is precisely cut according to the size of the open annulus remaining after excision of the patient's heart valve, with a plurality of holes being formed in the tissue. The tissue is situated between appropriately selected first and second stents so that the holes are registered with corresponding tissue alignment members in one of the stents, and the stents are positioned together to securely clamp the tissue therebetween. The constructed tissue heart valve is then mounted in a test chamber and visually inspected for leakage.

Abstract: This invention relates generally to a rapid assembly, concentric and flexible mating stent, tissue heart valve which can be assembled from prefabricated, sterile kits by a non-surgeon in the limited time available in an operating room. The kits provide the necessary tools and apparatus for harvesting the tissue and measuring the open annulus within the patient's heart. In addition, the kits contain size-specific components to be used during the rapid manufacture of the tissue heart valve.

Abstract: A concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. A tester for rapidly testing a tissue heart valve is provided comprising a substantially transparent viewing chamber having a plurality of size-specific mounts for mounting the valve within the chamber. The tester further comprises an element for displacing a volume of solution through the valve to test the opening and closing of the valve and to determine the amount of leakage through the valve when the valve is in a closed position.

Abstract: A method for assembling a concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. A plurality of prefabricated kits are also provided which enable the valve to be assembled with autogenous tissue in the limited time, i.e., 10 minutes or less, available in the operating room. A series of obturators may be used to size an annulus of the heart to be fitted. A precisely-configured cutting die is used to produce a precisely-cut tissue with a plurality of heart valve leaflets when the tissue is positioned between the first and second stents.

Abstract: A tissue heart valve test device which is capable of testing the valves in a rapid manner before implantation to ensure that there are no unacceptable leaks or flaws. The test device enables the valve to be tested in the operating room during the open heart procedure. The test device is configured with a chamber which allows the user to thoroughly visually inspect the valve as part of the test criteria. In addition, the test device is provided with size-specific mounts which are adapted to the particular valve to be tested.

Abstract: A concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. A plurality of prefabricated kits are also provided which enable the valve to be assembled with autogenous tissue in the limited time, i.e., 10 minutes or less, available in the operating room. The inner stent can be configured with a plurality of tissue alignment members extending outward from the inner stent to corresponding holes cut in the tissue. The outer stent can be configured with posts adapted for nesting with corresponding inner stent posts, and integrated with self-adjusting tensioning means, to exert a substantially uniform clamping force on the tissue sufficient to secure the tissue between the stents.

Abstract: A sealing mechanism for a pair of conduits held together by means of one or more frangible connectors. Each conduit has a pivoted disc-shaped butterfly valve which is spring biased to a closed position. The butterfly valves are normally held open by a flat pivoted spacer, and are released when the frangible connectors are broken and the valves move away from the spacer. A mechanism for positively closing and latching the butterfly valves in a closed position is included in the valve assembly. The valves and the spacer together form a thin flat co-planar assembly when the valves are in their open position so as to minimize turbulence in the fluid passing through the conduits thereby reducing resistance to fluid flow to an absolute minimum.

Abstract: This invention relates generally to a rapid assembly, concentric and flexible mating stent, tissue heart valve which can be assembled from prefabricated, sterile and disposable kits by a non-surgeon in the limited time available in an operating room. The kits provide the necessary tools and apparatus for harvesting the tissue and measuring the open annulus within the patient's heart. In addition, the kits contain size-specific components to be used during the rapid manufacture of the tissue heart valve.

Abstract: A concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. A plurality of prefabricated kits are also provided which enable the valve to be assembled with autogenous tissue in the limited time, i.e., 10 minutes or less, available in the operating room. The inner stent can be configured with a plurality of tissue alignment members extending outward from the inner stent to corresponding holes cut in the tissue. The outer stent can be configured with posts adapted for nesting with corresponding inner stent posts, and integrated with self-adjusting tensioning means, to exert a substantially uniform clamping force on the tissue sufficient to secure the tissue between the stents.

Abstract: A concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. A plurality of prefabricated kits are also provided which enable the valve to be assembled with autogenous tissue in the limited time, i.e., 10 minutes or less, available in the operating room. The inner stent can be configured with a plurality of tissue alignment members extending outward from the inner stent to corresponding holes cut in the tissue. The outer stent can be configured with posts adapted for nesting with corresponding inner stent posts, and integrated with self-adjusting tensioning means, to exert a substantially uniform clamping force on the tissue sufficient to secure the tissue between the stents.

Abstract: A quick disconnect coupling for connecting together two conduits in a high pressure fluid-carrying system. The coupling includes a female part (coupler) and a male part (nipple) each provided with a flow through channel, and each provided with a cut-off valve. The nipple is designed to be inserted into the flow-through channel of the coupler to cause the two parts automatically to be firmly latched together and to be sealed to one another during a pre-mating condition, without opening cut-off valves in the nipple and coupler. This initial pre-mating action isolates any fluid contained in the two parts of the coupling from the environment. Then, an axial force applied to the outer housing of the coupler causes both the nipple and coupler valves to open to establish fluid flow through the coupling.

Abstract: A sealing mechanism for a pair of conduits held together by means of a frangible connector is described. Each conduit has a center pivoted butterfly valve with valve discs which are spring biased to a closed position. The valve discs are mutually abutting and normally hold each other open, but are released when the frangible connector is broken. Each disc is pivoted about an offset from a pivot support member, and the inner conduit walls are tapered between the open and closed positions of the disc so as to reduce the turning friction between the disc and the conduit walls. A mechanism for positively closing and latching the disc is a closed position is described. This mechanism is contained in a housing which is sealed off from the fluid containing portion of the conduit.

Abstract: A connector for connecting together two ends of a fluid-carrying line comprises two coupling halves. The female half includes a cylindrical female housing. A support sleeve is concentric with and mounted around part of the female housing, and the forward end is threaded to receive the male half. An actuator sleeve is around the support sleeve. A movable locking member in the form of balls are seated in opening through the support sleeve against the actuator sleeve. A trigger ring inside the support sleeve slides between a blocking position under the balls and an unblocking position releasing the balls. One surface of the actuator sleeve urges the balls against the trigger ring. The threaded forward end of the male half engages the threads of the female half. A nose section on the male half, which extends forward of the threads, engages a trigger actuator ring in the female half.