Abstract: The present invention provides a tissue cutting device and a method for accurately cutting tissue into tissue leaflets for autologous tissue heart valves in a minimal amount of time. The device includes a flexible backing pad located between a rotatable rotary table and a puck which houses several sharpened blades. The tissue to be cut is located on the flexible backing pad adjacent to the blades. The rotary table includes a hemispherically shaped raised cutting bar on the upper surface. When the rotary table is rotated, the cutting bar pushes the tissue against the blades in the puck, cutting the tissue into the desired shape.

Abstract: An apparatus and a method for constructing a heart valve prepared from autologous tissue. Three tissue leaflets are held in place with tissue anchors on a tissue mounting frame having an annular base and a plurality of commissure posts extending from the base. An elastomeric sheath rests gently on the tissue leaflets to prevent the leaflets from coming off of the anchor hooks and encloses the leaflets to form valve cusps. The leaflets touch each other on a coaptation line with an angle of approximately 65° relative to the commissure post. The heart valves can be constructed intraoperatively in a short time, typically ten minutes. The low coaptation angle and the fact that the leaflets are held in place without being clamped between two unyielding members minimize stress on the tissue.

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 assembling a heart valve is provided for use with an inner and a spreadable outer stent. The outer stent is mounted onto a spreading tool including a spreading ring, and expander, and a plunger. A protective cap is placed over the outer stent and plunger to prevent relative rotation of the outer stent to the expander prior to the complete spreading of the outer stent. The inner stent, with tissue wrapped thereon, is mounted onto an insertion tool including a mandrel having a plurality of guide rails for mating with slots of the spreading ring, wherein the guide rails in the slots provide axial and radial alignment of the inner and outer stents. The mandrel holding the inner stent is inserted through the spreading ring holding the outer stent, thereby releasing the mated stents from the spreading ring and mandrel and securely clamping the tissue between the stents.

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 method for constructing stents for autologous tissue heart valves is provided. The method includes creating a stent profile primitive which is rotated about a first axis to create a solid stent blank having inner and outer surfaces. First and second splines are created and intersected with the inner and outer surfaces, respectively, to form a plurality of planes. Posts are formed on the stent blank by removal of material above the planes, and filleting is performed to provide a smooth upper surface for each post. Additional features corresponding to whether the stent is an inner or an outer stent for the heart valve are added, and the final stent shape is input into machine tooling which cuts an electrode into the corresponding stent shape. The electrode is then used to dissolve a pattern into a block of metal, such as a nickel-steel alloy, to form the final mold of the stent.

Abstract: The present invention provides a novel tissue cutting device which accurately cuts the tissue to a predetermined configuration in a minimal amount of time, and where the tissue may then be used in an autologous heart valve. The disposable tissue cutting die of the present invention is comprised of a cutting die assembly and a cutting base assembly. The cutting die assembly retains a continuous blade with razor sharpened edges that enclose a desired spatial configuration. The cutting base assembly includes a rotatable cutting pad on which the tissue to be cut may be placed. The cutting die assembly and cutting base assembly are adpated to cooperate to cut the tissue when the cutting die assembly is inserted into the cutting base assembly and rotated approximately 180 degrees.

Abstract: The present invention provides a novel tissue cutting device for autologous tissue heart valves which accurately cuts the tissue to a predetermined configuration in a minimal amount of time. The disposable tissue cutting die of the present invention is comprised of a cover, a base member, a continuous blade enclosing a desired spatial configuration and an actuator for forcing said tissue against the entire perimeter of the blade.

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: 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.

Abstract: An assembly tool for a bioprosthetic heart valve is disclosed. The tool assembles a valve having an inner and a spreadable outer stent, and includes a spreading ring with an elevated lip to hold the spread outer stent, an expander having fingers which contact the outer stent base to spread it apart, and a plunger to spread the fingers of the outer stent. An assembly mandrel having indexing rails allows the insertion of the inner stent into the spread outer stent while maintaining the correct rotational positioning of both stents. A shedding cap protects the tissue wrapped on the inner stent from abrasion during insertion.

Abstract: A stentless heart valve assembled from autologous tissue is provided. The tissue is cut into a rectangular shape, folded, and stapled at several locations to form the cusps of the valve. The outer walls of the valve are pinched at the midpoint of each cusp to prevent the cusps from adhering to the valve walls. The ends of the rectangle are then stapled to form the annular valve itself.

Abstract: The present invention provides a heart valve measurement tool in the form of an obturator. The obturator is specifically configured to measure the size of the annulus of the heart to be fitted with a prosthetic heart valve. A plurality of obturators of varying sizes are utilized to determine the appropriate valve size.

Abstract: 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.

Abstract: The present invention provides a novel tissue cutting device for autologous tissue heart valves which accurately cuts the tissue to a predetermined configuration in a minimal amount of time. The disposable tissue cutting die of the present invention is comprised of a cover, a base member, a continuous blade enclosing a desired spatial configuration and an actuator for forcing said tissue against the entire perimeter of the blade.

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.