Tricuspid prosthetic tissue heart valve

• US 4,470,157 A
• Filed: 04/19/1983
• Issued: 09/11/1984
• Est. Priority Date: 04/27/1981
• Status: Expired due to Term

• Current Assignee: Autogenics Co.
• Original Assignee: Jack W. Love
• Inventors: Love, Jack W.
• Primary Examiner(s): Frinks, Ronald L.
• Application Number:
  US06/486,376
• Time in Patent Office: 511 Days
• Field of Search: 3/1.5, 3/1
• US Class Current: 623/2.15
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Abstract

A method and apparatus for providing a tricuspid heart valve that can be assembled with autogenous or foreign tissue using a prefabricated kit comprised of two stents that mate together and a sewing ring, one stent inside or below the other, with the tissue clamped between the stents. The inner or lower stent has a scalloped wall to provide three equally spaced peaks extending from an annular base. The stents may have interlocking means at or near their base to not only lock them together, but also to clamp the tissue in place more securely. In the case of having the one stent inside the other, both stents may have a scalloped wall. The tissue is first placed over the inner stent, then after the outer stent is placed over the tissue, excess tissue is trimmed. The mated stents secure the tissue securely in place. The outer stent may have a ledge along its upper edge overhanging the inner stent to clamp the tissue. In the case of having one stent below the other, the upper stent may be a short cylinder scalloped at both ends to fit as a cap over the lower stent. Alternatively, the upper stent may be formed from three sections of bent rods welded at the peaks. In either case, the upper stent fits closely as a cap over the lower stent, and the lower stent may have an annular base or a scalloped base. In each embodiment, the stents may be made of thermoplastic material and covered by fabric that is thermobonded, i.e., secured to the stents by applying heat and pressure to at least selected areas.

Claims

1. A method for fabricating a prosthetic tricuspid tissue heart valve in the limited time available during open heart surgery using two prefabricated stents that mate together with the possibility of using live tissue taken from the patient secured between the stents, at least one stent over which said tissue is placed to form a tricuspid valve from said tissue having a scalloped wall with the three peaks equally spaced apart to define three peaks of the tricuspid valve, said peaks extending approximately parallel to the axis of the one stent, comprising the steps of forming said tissue with its inside surface over the outside surface of said one stent in one or more sections, as required, to form said tricuspid heart valve using said one stent, placing the other stent in a close mating position with said one stent over the outside surface of the tissue formed on said one stent, thereby securing said tissue between stents without reliance on stitching to the stents, or other time consuming methods, and securing the inner and outer stents together with said tissue secured therebetween.

2. A method as defined in claim 1 wherein said other stent also has a scalloped wall with three peaks equally spaced apart, and said other stent is placed around said one stent over said tissue with its peaks overlaying the peaks of said one stent.

3. A method as defined in claim 1 wherein said outer stent also has a scalloped wall with three peaks equally spaced apart, and is shaped at its end opposite said peaks to conform to the scalloped end of said one stent, and wherein said other stent is fitted as a cap over said one stent with the tissue passing from outside said one stent to the inside of said other stent.

4. A method as defined in claim 2 or 3 wherein said one stent is annular and has a circular base opposite the scalloped end.

5. A method as defined in claim 2 or 3 wherein said one stent is shaped at its end opposite said peaks to conform to its scalloped end.

6. A method as defined in claim 2 wherein both stents are annular and have a circular base opposite the scalloped ends thereof.

7. The method as defined in claim 2 wherein said other stent has a ledge along its scalloped edge overhanging the scalloped end of said one stent to clamp said tissue in place.

8. A method as defined in claim 2 or 7 wherein said other stent is split to enable it to be expanded while placing it over said one stent covered with said tissue.

9. A method as defined in claim 8 wherein said tissue is a rectangular section wrapped around said one stent, and wherein free ends of said tissue extend out between the split ends of said other stent, thereby to secure the ends of the tissue.

10. A method as defined in claim 9 wherein said stents are covered with fabric, and the split in said other stent is secured by stapling or stitching through fabric and through tissue extending through the split of said other stent.

11. A method as defined in claim 8 wherein each stent is annular and has a base opposite the scalloped end thereof and both of said stents are provided with interlocking grooves and ridges around their bases to crimp the tissue and interlock said stents.

12. A method as defined in claim 1 wherein said stents are of the same size, such that said other stent fits as a cap over said one tissue covered stent, and said other stent is comprised of three rods bent to fit the scalloped walls between peaks of said one stent, and said rods are secured together at their peaks.

13. A method as defined in claim 12 wherein said bent rods are secured together by a short section of rod prewelded at each peak across the outside of the bent rods.

14. A method as defined in claim 12 or 13 wherein said bent rods have a circular section.

15. A method as defined in claim 1 wherein said stents are of the same diameter and each has a scalloped wall with three peaks equally spaced apart, said peaks extending parallel to the axis thereof, said other stent is shaped at its end opposite said peaks to conform to the scalloped end of the one stent, and said other stent is fitted over said tissue covering said one stent.

16. A method as defined by claim 1 wherein said stents are made of thermoplastic material and fabric is bonded over said stents by applying heat and pressure to said fabric and stents over at least selected areas, thereby thermobonding said fabric onto said stents.

17. A tricuspid tissue heart valve comprised of two mated stents and tissue in one or more sections, said tissue having its inner surface extending over the outer surface of one stent to form said tricuspid heart valve, said two stents mating closely together to secure said tissue between the stents, wherein at least said one stent over which said tissue is placed has a scalloped wall with three peaks equally space apart to define three peaks of the tricuspid valve, said peaks extending approximately parallel to the axis of the one stent in the direction of flow through said valve, and the other stent having a configuration to secure said tissue between it and said one stent at least along the scalloped walls of said one stent between said peaks.

18. Apparatus as defined in claim 17 wherein said other stent also has a scalloped wall with three peaks equally spaced apart, said other stent being around said one stent over said tissue with peaks of said outer stent overlaying the peaks of said one stent.

19. Apparatus as defined in claim 17 wherein said other stent also has a scalloped wall with three peaks equally spaced apart, and said other stent is shaped at its end opposite said peaks to conform to the scalloped end of said one stent, and wherein both stents are of the same size, said other stent being fitted as a cap over said one tissue with said tissue passing from outside said one stent to the inside of said other stent.

20. Apparatus as defined in claim 18 or 19 wherein said one stent is annular and has a circular base opposite the scalloped end.

21. Apparatus as defined in claim 18 or 19 wherein said one stent is shaped at its end opposite said peaks to conform to its scalloped end.

22. Apparatus as defined in claim 18 wherein both stents are annular and have a circular base opposite the scalloped ends thereof.

23. Apparatus as defined in claim 18 or 22 wherein said other stent has a ledge along its scalloped edge overhanging the scalloped end of said one stent to clamp said tissue cylinder in against the scalloped end of said one stent.

24. Apparatus as defined in claim 23 wherein said other stent is split to enable it to be expanded while placing it over the one stent covered with said tissue.

25. Apparatus as defined in claim 24 wherein free ends of said tissue extend out between the split end of said other stent, thereby to secure the ends of said tissue.

26. Apparatus as defined in claim 24 wherein each stent is annular and has a circular base opposite the scalloped end thereof and said one and said other stents are provided with interlocking annular grooves and ridges around their bases to crimp said tissue and interlock the stents.

27. Apparatus as defined in claim 17 wherein said other stent is of the same size as said one stent, such that said other stent fits as a cap over said one stent, and said other stent is comprised of three rods bent to fit the scalloped wall between peaks of said one stent, and said rods are secured together at their peaks.

28. Apparatus as defined in claim 27 wherein said bent rods are secured together at the peaks by a short section of rod at each peak welded on the outside of the stent to the ends of the rods being secured together.

29. Apparatus as defined in claim 27 or 28 wherein said bent rods have a circular cross section.

30. Apparatus as defined in claim 17 wherein said other stent also has a scalloped wall with three peaks equally spaced apart, said peaks extending parallel to the axis thereof and said other stent is shaped at its end opposite said peaks to conform to the scalloped end of the one stent, and wherein said other stent is of a larger diameter, such that the other stent fits over the one tissue covered stent.

31. Apparatus as defined in claim 17 wherein each of said stents is comprised of thermoplastic material and covered by fabric bonded thereto over at least selected areas by the application of heat and pressure to said fabric and stents thereby thermobonding said fabric onto said stents.