摘要:
A sizer for assessing the geometry of a heart valve annulus. The sizer preferably includes a circular sizing portion for measuring the diameter of the valve annulus. The sizing portion has radial spokes. The spokes are used to compare the symmetry of the commissures to the expected symmetry of a normal heart valve. The sizer preferably has one or more legs attached to the sizing portion for comparing the contour of the line of valve leaflet attachment to the expected contour of a normal heart valve having a diameter substantially equivalent to the measured diameter of the valve annulus.
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:
The present invention provides a single-use surgical cutting device for cutting a planar piece of tissue into a predetermined shape. The cutting device comprises a housing having one or more side walls, a top, a base, and a hollow interior portion. A blade retaining member is disposed within the housing between and substantially parallel to the top and base such that the blade retaining member can move vertically between the top and base. A blade defining a predetermined tissue shape is disposed on the bottom surface of the blade retaining member. A pressure mechanism creates potential energy for exerting a downward force on the top surface of the blade retaining member, such that when the blade retaining member is released, the pressure mechanism forces the blade retaining member downward with sufficient force to cut the piece of tissue. An actuator is configured to release the blade retaining member only once without disassembling the housing and resetting the pressure mechanism. Thus, a piece of tissue can be placed beneath the bottom surface of the blade retaining member on or parallel to the base and the actuating mechanism can be actuated to release the downward force on the blade retaining member to cut the piece of tissue into the desired shape, but the cutting device cannot readily be reused by an operator.
摘要:
A sizer for assessing the geometry of a heart valve annulus including a handle portion for holding the sizer and a sizing portion. The sizing portion is preferably in the shape of an arch having an apex and two legs, each of which has a base adjoining the handle portion. The legs of the arched sizing portion are separated from each other by a predetermined distance that corresponds to the expected separation of commissures of a normal heart valve annulus. The height of the arch (measured from the base of each leg to the apex) corresponds to a predetermined leaflet height that approximates the expected height of a leaflet of a normal heart valve. For aortic valve reconstruction, the instrument is inserted into the opened aortic root following removal of the native valve tissue and is used to assess the distance between the commissures, the leaflet height, and the symmetry of the commissures of the exposed valve annulus.
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.