Heart valve prosthesis

• US 4,680,031 A
• Filed: 10/24/1984
• Issued: 07/14/1987
• Est. Priority Date: 11/29/1982
• Status: Expired due to Fees

• Current Assignee: Tascon Medical Technology Corporation
• Original Assignee: Tascon Medical Technology Corporation
• Inventors: Alonso, Manuel T.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): Cannon, Alan W.
• Application Number:
  US06/664,150
• Time in Patent Office: 993 Days
• Field of Search: 623/2
• US Class Current: 623/2.13
• 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 2/2415 Manufacturing methods

Abstract

A "tissue valve type" heart valve prosthesis is disclosed which has a biocompatible plastic sewing ring adapted to be surgically implanted into the mitral, aortic or tricuspid annulus of the human heart. The sewing ring has internal square threads and a biocompatible fabric mesh or cloth is embedded into the sewing ring so that the cloth can be fully wrapped around the sewing ring covering all of its plastic surfaces except for the internally protruding threads. A biocompatible plastic stent support ring has externally disposed threads to lock with the threads of the sewing ring in approximately one turn, or less. The stent support ring also embeds a biocompatible fabric mesh which can be wrapped around the stent support ring to cover all of its plastic surfaces, except for the protruding threads, and to form a cloth pocket wherein a solid stent is mounted. A porcine trileaflet valve is mounted to the stent. When the heart valve prosthesis is as implanted into the heart, the threads of the sewing ring and of the stent support ring interlock, and there are no plastic or metal surfaces, uncovered by biocompatible fabric, to be exposed to blood flow. Processes for making the solid metal stent by laser cutting, and the sewing and stent support rings by a specifically adapted plastic molding procedure, are also disclosed.

Claims

1. A heart valve prosthesis comprising:

a sewing ring made of biocompatible plastic material, the sewing ring having an exterior wall and a threaded interior,

a first cloth of biocompatible material embedded in the sewing ring so that internal threads of the sewing ring and the exterior wall of the sewing ring are disposed on different sides of the first cloth, said first cloth being folded over the exterior wall of the sewing ring to provide a cloth ring capable of accepting sutures whereby the sewing ring can be surgically mounted into a suitable annulus in the human heart;

a stent support ring made of biocompatible plastic material, the stent support ring having an interior wall and a threaded exterior, the threaded exterior of the stent support ring being configured and dimensioned to be threadably mountable within the internally threaded portion of the sewing ring;

a second cloth of biocompatible material embedded in the stent support ring so that external threads of the stent support ring and the interior wall of the stent support ring are disposed on different sides of the second cloth, said second cloth being folded over the interior wall of the sewing ring to provide a cloth pocket capable of accepting a stent;

a stent having commissural posts mounted in the pocket and thereby being substantially completely enclosed in the second cloth, and

valve means of animal origin mounted to the stent for functioning as a heart valve when said heart valve prosthesis is mounted into the human heart.

2. The heart valve prosthesis of claim 1 wherein the stent is a tubular member comprising a substantially solid plate of biocompatible metal.

3. The heart valve prosthesis of claim 2 wherein the stent includes a plurality of apertures adapted for receiving sutures for mounting the valve means to the stent.

4. The heart valve prosthesis of claim 3 wherein the solid plate of the stent comprises an elongated substantially flat plate which had been bent to meet at two opposite edges, said edges having been welded together with an overlying plate.

5. The heart valve prosthesis of claim 1 wherein the sewing ring and the stent support ring comprise thermoplastic material which can be formed by a molding process.

6. The heart valve prosthesis of claim 5 wherein the first and second cloth are embedded into the sewing ring and stent support ring, respectively, by a plastic molding process.

7. The heart valve prosthesis of claim 6 wherein the first and second cloth both comprise poly acetate material.

8. In a heart valve prosthesis of the type comprising:

a sewing ring member having a circular first opening therethrough, an exterior wall, and an interior wall surrounding said first opening, said interior wall bearing one or more interior screw threads extending interior to said inner wall and into said first opening;

a valve member having a second opening therethrough, an exterior wall, and an interior wall surrounding said second opening, said exterior wall of said valve member having exterior screw threads extending exterior to said exterior wall and corresponding to said interior screw threads of said sewing ring member such that said valve member may be screwed into said sewing ring; and

a prosthetic heart valve means mounted to said valve member for regulating flow of blood through said second opening through said valve member;

the improvement wherein;

said sewing ring member is fabricated of a biocompatible plastic, and wherein said heart valve includes a first cloth of biocompatible material embedded within said sewing ring member such that said interior screw threads of said sewing ring member are interior to said first cloth and said exterior wall of said sewing ring member is exterior to said first cloth.

9. A heart valve prosthesis according to claim 8 wherein said valve member is fabricated of a biocompatible plastic and wherein said heart valve prosthesis further comprises a second cloth of biocompatible material embedded within said valve member such that said exterior screw threads of said valve member are exterior to said second cloth and said interior wall of said valve member is interior to said second cloth.

10. A heart valve according to claim 8 wherein said first cloth is folded over said sewing ring member and covers said exterior wall of said sewing ring member.

11. A heart valve according to claim 9 wherein said second cloth is folded over said valve member and covers said interior wall of said valve member.

14. A heart valve according to claim 9 or 10 or 11 wherein said prosthetic heart valve means comprises a prosthetic tissue valve and wherein said heart valve prosthesis further comprises stent means, mounted to said valve member for mounting said prosthetic tissue valve.

15. A heart valve prosthesis according to claim 14 wherein said stent means has a third opening therethrough in communication with said second opening through said valve member and wherein said stent means further has an interior wall surrounding said third opening and an exterior wall, and wherein said second cloth covers said interior wall of said stent means.

16. A heart valve prothesis according to claim 15 wherein said second cloth further covers said exterior wall of said stent means.

12. A heart valve prosthesis of the type comprising:

a sewing ring member having a circular first opening therethrough, an exterior wall, and an interior wall surrounding said first opening, said interior wall bearing one or more interior screw threads extending interior to said interior wall and into said first opening;

a valve member having a second opening therethrough, an exterior wall and an interior wall surrounding said second opening, said exterior wall of said valve member having exterior screw threads extending exterior to said exterior wall and corresponding to said interior screw threads of said sewing ring member such that said valve member may be screwed into said sewing ring member; and

prosthetic heart valve means mounted to said valve member for regulating flow of blood through said second opening through said valve member;

the improvement wherein;

said valve member is fabricated of a biocompatible plastic and wherein said heart valve prosthesis further comprises a cloth of biocompatible material embedded within said valve member such that said exterior screw threads of said valve member are exterior to said cloth and said interior wall of said valve member is interior to said cloth.

13. A heart valve prosthesis according to claim 12 wherein said cloth is folded over said valve member and covers said interior wall of said valve member.

17. A heart valve according to claim 12 or 13 wherein said prosthetic heart valve means comprises a prosthetic tissue valve and wherein said heart valve prosthesis further comprises stent means, mounted to said valve member, for mounting said prosthetic tissue valve.

18. A heart valve prosthesis according to claim 17 wherein said stent means has a third opening therethrough in communication with said second opening through said valve member and wherein said stent means further has an interior wall surrounding said third opening and an exterior wall, and wherein said cloth covers said interior wall of said stent means.

19. A heart valve prosthesis according to claim 18 wherein said second cloth further covers said exterior wall of said stent means.

20. In a heart valve prosthesis of the type comprising:

a first annular sewing ring member having a circumferential first wall and a circumferential second wall bearing at least one circumferential screw thread;

an annular valve member having an opening therethrough and having a circumferential first wall and a circumferential second wall bearing at least one circumferential screw thread corresponding to said circumferential screw thread of said sewing ring member such that said valve member may be screwed on to said sewing ring member; and

prosthetic heart valve means mounted to said heart valve member for regulating flow of blood through said opening of said valve member;

the improvement comprising;

a first tubular cloth having a first side and a second side, embedded in said sewing ring member such that said at least one screw thread of said sewing ring member extends from said first side of said cloth and such that said first circumferential wall extends from said second side of said tubular cloth.

21. A heart valve prosthesis according to claim 20 wherein said improvement further comprises a second tubular cloth having a first side and a second side, embedded within said valve member such that said circumferential screw threads of said valve member extend from said first side of said second tubular cloth and said first circumferential wall of said valve member extends from said second side of said second tubular cloth.

22. A heart valve prosthesis according to claim 20 or 21 wherein said first tubular cloth member is folded over said sewing ring member and covers said first circumferential wall of said sewing ring member.

23. A heart valve prosthesis according to claim 21 wherein said second cloth is folded over said heart valve member and covers said first circumferential wall of said heart valve member.

24. In a heart valve prosthesis of the type comprising:

an annular sewing ring member having a first circumferential wall and a second circumferential wall bearing at least one circumferential screw thread;

an annular valve member having an opening therethrough and having a circumferential first wall and a circumferential second wall bearing at least one circumferential screw thread corresponding to said circumferential screw thread of said sewing ring member such that said valve member may be screwed on to said sewing ring member; and

prosthetic heart valve means mounted to said annular valve member for controlling flow of blood through said opening of said valve member;

the improvement comprising;

a tubular cloth having a first side and a second side, embedded within said valve member such that said circumferential thread of said valve member extends from said first side of said tubular cloth and such that said first circumferential wall of said valve member extends from said second side of said tubular cloth.

25. A heart valve prosthesis according to claim 24 wherein said tubular cloth is folded over said valve member covering said circumferential first wall of said valve member.