摘要:
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.
摘要:
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.
摘要:
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.
摘要:
The present invention provides a prosthetic heart valve holder specifically configured to hold a prosthetic heart valve comprised of a stent. The heart valve holder assembly has three main components: a handle, a valve capture loop assembly and a valve retainer. The prosthetic heart valve is secured to the valve retainer by a loop of suture as the surgeon sutures or attaches the valve to the annulus of the heart. Thus, the valve holder assembly facilitates attachment of the prosthetic valve to the annulus so that the procedure may be performed in a time and labor efficient manner.
摘要:
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.
摘要:
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.
摘要:
A concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. The valve comprises at least one piece of tissue clamped between an inner and an outer stent. The outer stent is configured with a plurality of spaced posts extending from a base, wherein the posts are configured with open windows so that at least a portion of the tissue in the assembled valve is exposed through the windows. Several embodiments of the outer stent are disclosed, including where the outer stent comprises a crimped metal wire frame covered with a Dacron tube.
摘要:
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.
摘要:
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.
摘要:
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.