Suture rings for rotatable artificial heart valves

• US 5,755,783 A
• Filed: 07/29/1996
• Issued: 05/26/1998
• Est. Priority Date: 07/29/1996
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Stobie, Robert, Guo, George
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/688,672
• Time in Patent Office: 666 Days
• Field of Search: 623/2, 623/900
• US Class Current: 623/2.39
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A suture ring for a rotatable artificial heart valve apparatus has a ring member covered by a fabric material. A portion of the fabric material covers a portion of the inner surface of the ring member. At least one protuberance is formed on the inner surface of the ring member so as to mitigate the frictional resistance to rotation which results from compression of the fabric between the suture ring and the heart valve. Thus, desirable rotation of the heart valve relative to the suture ring is assured over a range of thicknesses of the fabric material.

Claims

1. A rotatable artificial heart valve apparatus comprising:

a) an annular valve body having a blood flow passage extending longitudinally therethrough and an outer surface;

b) at least one occluder mounted within the blood flow passageway of said annular valve body to intermittently block the flow of blood through said passageway;

c) a suture ring mounted on the outer surface of said valve body and rotatable thereon, said suture ring comprising;

i) a ring member having an inner surface, an outer surface, a proximal edge, and a distal edge; and

,

ii) a needle-penetrable fabric covering disposed on said ring member, a portion of said fabric being interposed between the inner surface of said ring member and the outer surface of said valve body;

d) at least one protuberance formed on the inner surface of said ring member defining the only surface on said valve body which compresses said portion of said fabric between the inner surface of said ring member and said outer surface of the valve body.

2. The heart valve apparatus of claim 1 wherein said at least one protuberance comprises:

a) a first annular rib formed about the inner surface of said ring member adjacent the proximal edge thereof; and

,

b) a second annular rib member formed about the inner surface of said ring member adjacent the distal edge thereof.

3. The heart valve apparatus of claim 1 wherein:

a) an annular tracking groove is formed in the outer surface of said heart valve body;

b) an annular tracking rib is formed on the inner surface of said ring member; and

,

c) the annular tracking rib formed on the inner surface of said ring member being sized and configured to snap into the annular tracking groove formed on the outer surface of said valve body so as to retain said ring member on said valve body such that said valve body is rotatable relative to said suture ring.

4. The heart valve apparatus of claim 1 wherein said needle-penetrable fabric cover is formed of fabric material selected from the list of materials consisting of:

polytetrafluoroethylene;

polypropylene;

polyester; and

,

velour.

5. The heart valve apparatus of claim 1 wherein said needle-penetrable fabric is woven.

6. Then heart valve apparatus of claim 1 wherein said needle-penetrable fabric material is knitted.

7. The heart valve apparatus of claim 1 wherein the entire surface of said heart valve body and said ring member between which said fabric material is interposed is definable as a first surface area, and wherein the friction-creating contact surfaces of the protuberance(s) and adjacent portion of the heart valve body is definable as a second surface area, and wherein said second surface area is no more than 20% of said first surface area.

8. The heart valve apparatus of claim 1 wherein said heart valve apparatus is intended for implantation at the mitral location, and wherein said suture ring further comprises an annular sponge positioned about the outer surface of said ring member, adjacent the distal end thereof, said sponge being covered by said needle-penetrable fabric material, and being configured so as to define a flange having an outer diameter substantially greater than the outer diameter of the ring member.

9. The heart valve apparatus of claim 1 wherein said heart valve apparatus is intended for implantation at the aortic location, and wherein said suture ring further comprises an annular sponge positioned about the outer surface of said ring member, said annular sponge extending generally from the proximal edge of the ring member to the distal edge thereof and being tapered so as to define a smaller outer diameter at the proximal edge of the ring member than at the distal edge thereof.

10. The heart valve apparatus as recited in claim 2 further comprising a friction control gap defined by one of said first and second annular ribs and said annular valve body, a width of said friction control gap cooperating with a thickness of said fabric material to determine torque required to effect rotation of the valve body within the suture ring.

11. The heart valve apparatus of claim 1 wherein the length of said suture ring is no greater than the length of said valve body, thereby facilitating passage of the apparatus through a minimal access incision.

35. The heart valve apparatus of claim 1 wherein said needle-penetrable fabric cover is a seamless tube.

12. A rotatable artificial heart valve apparatus comprising:

a) an annular valve body having a blood flow passageway extending longitudinally therethrough and an outer generally cylindrical surface having a nominal diameter and a groove therein having a diameter less than the nominal diameter;

b) at least one occluder mounted within the blood flow passageway of said annular valve body to intermittently block the flow of blood through said passageway;

c) a suture ring mounted on the outer surface of said valve body and rotatable thereon, said suture ring comprising;

i) a ring member having an inner surface, an outer surface, a proximal edge, and a distal edge; and

,

ii) a needle-penetrable fabric covering disposed on said ring member, a portion of said fabric being interposed between the inner surface of said ring member and the outer surface of said valve body;

d) at least one protuberance formed on the outer surface of said valve body projecting outward from the outer surface and defining the only surface on said valve body which compresses said portion of said fabric between the inner surface of said ring member and said outer surface of the valve body.

13. The heart valve apparatus of claim 12 wherein said at least one protuberance comprises:

a) a first annular rib formed about the inner surface of said valve body adjacent the proximal edge thereof; and

,

b) a second annular rib member formed about the inner surface of said valve body adjacent the distal edge thereof.

14. The heart valve apparatus of claim 12 further comprising an annular tracking rib formed on the inner surface of said ring member

the annular tracking rib formed on the inner surface of said ring member being sized and configured to snap into the groove formed on the outer surface of said valve body so as to retain said ring member on said valve body such that said valve body is rotatable relative to said suture ring.

15. The heart valve apparatus of claim 12 wherein said needle-penetrable fabric cover is formed of fabric material selected from the list of materials consisting of:

polytetrafluoroethylene;

polypropylene;

polyester; and

velour.

16. The heart valve apparatus of claim 12 wherein said needle-penetrable fabric is woven.

17. The heart valve apparatus of claim 16 wherein said needle-penetrable fabric is woven velour.

18. Then heart valve apparatus of claim 12 wherein said needle-penetrable fabric material is knitted.

19. The heart valve apparatus of claim 18 wherein said needle-penetrable fabric material is knitted velour.

20. The heart valve apparatus of claim 12 wherein said needle-penetrable fabric material comprises a seamless tube.

21. The heart valve apparatus of claim 12 wherein the entire surface of said heart valve body and said ring member between which said fabric material is interposed is definable as a first surface area, and wherein the friction-creating contact surfaces of the protuberance(s) and adjacent portion of the heart valve body is definable as a second surface area, and wherein said second surface area is no more than 20% of said first surface area.

22. The heart valve apparatus of claim 12 wherein said heart valve apparatus is intended for implantation at the mitral location, and wherein said suture ring further comprises an annular sponge positioned about the outer surface of said ring member, adjacent the distal end thereof, said sponge being covered by said needle-penetrable fabric material, and being configured so as to define a flange having an outer diameter substantially greater than the outer diameter of the ring member.

23. The heart valve apparatus of claim 12 wherein said heart valve apparatus is intended for implantation at the aortic location, and wherein said suture ring further comprises an annular sponge positioned about the outer surface of said ring member, said annular sponge extending generally from the proximal edge of the ring member to the distal edge thereof and being tapered so as to define a smaller outer diameter at the proximal edge of the ring member than at the distal edge thereof.

24. The heart valve apparatus as recited in claim 13 further comprising a friction control gap defined by one of said first and second annular ribs and said annular valve body, a width of said friction control gap cooperating with a thickness of said fabric material to determine torque required to effect rotation of the valve body within the suture ring.

25. The heart valve apparatus of claim 12 wherein the length of said suture ring is no greater than the length of said valve body, thereby facilitating passage of the apparatus through a minimal access incision.

26. A suture ring which is adapted to be rotatably mountable on the generally cylindrical outer surface of a prosthetic heart valve apparatus, said suture ring comprising:

a) a ring member having an inner surface, an outer surface, a proximal edge, and a distal edge;

b) a needle-penetrable fabric covering disposed on said ring member, a portion of said fabric being interposed between the ring member and the outer surface of the prosthetic heart valve apparatus, when the suture ring is mounted on said prosthetic heart valve apparatus; and

c) at least one protuberance formed on said inner surface of said ring member defining the only surface on said suture ring which compresses said portion of said fabric between the inner surface of said ring member and the outer surface of the prosthetic heart valve apparatus, when the suture ring is mounted on said prosthetic heart valve apparatus.

27. The suture ring of claim 26 wherein said at least one protuberance comprises:

a) a first annular rib formed about the inner surface of said ring member adjacent the proximal edge thereof; and

,

b) a second annular rib member formed about the inner surface of said ring member adjacent the distal edge thereof.

28. The suture ring of claim 26 wherein the suture ring is intended for mounting on a prosthetic heart valve apparatus which has an annular tracking groove formed about it'"'"'s generally cylindrical outer surface, and wherein said suture ring further comprises:

an annular tracking rib formed on the inner surface of said ring member, said annular tracking rib being sized and configured to snap into the annular tracking groove formed on the outer surface of the prosthetic heart valve apparatus so as to retain said ring member on said heart valve apparatus, such that said heart valve apparatus is rotatable relative to said suture ring.

29. The suture ring of claim 26 wherein said needle-penetrable fabric covering is formed from material selected from the group consisting of:

polytetrafluoroethylene;

polypropylene;

polyester; and

, velour.

30. The suture ring of claim 26 wherein said needle-penetrable fabric is woven.

31. The suture ring of claim 26 wherein said needle-penetrable fabric is knitted.

32. The heart valve apparatus of claim 26 wherein the entire surface of said heart valve body and said ring member between which said fabric material is interposed is definable as a first surface area, and wherein the friction-creating contact surfaces of the protuberance(s) and adjacent portion of the heart valve body is definable as a second surface area, and wherein said second surface area is no more than 20% of said first surface area.

33. The suture ring of claim 26 wherein said suture ring is configured for use with a heart valve apparatus which is intended for implantation at the mitral location, and wherein said suture ring further comprises an annular sponge positioned about the outer surface of said ring member, adjacent the distal end thereof, said sponge being covered by said needle-penetrable fabric material, and being configured so as to define a flange having an outer diameter substantially greater than the outer diameter of the ring member.

34. The suture ring of claim 26 wherein said suture ring is configured for use with a heart valve apparatus intended for implantation at the aortic location, and wherein said suture ring further comprises an annular sponge positioned about the outer surface of said ring member said annular sponge extending generally from the proximal edge of the ring member to the distal edge thereof and being tapered so as to define a smaller outer diameter at the proximal edge of the ring member than at the distal edge thereof.

36. A rotatable artificial heart valve apparatus comprising:

a) an annular valve body having a blood flow passageway extending longitudinally therethrough and an outer surface;

b) a suture ring mounted on the outer surface of said valve body and rotatable thereon, said suture ring including an inner surface, an outer surface, a proximal edge, and a distal edge;

c) a fabric sheet being interposed between the inner surface of said suture ring and the outer surface of said valve; and

d) at least one protuberance formed on either the outer surface of said valve body or the inner surface of said suture ring for compressing said fabric sheet between the inner surface of said suture ring and said outer surface of the valve body, said at least one protuberance defining a surface area of no more than 20% of the smaller of the surface areas of the inner surface of the suture ring and the outer surface of the valve body, wherein the at least one protuberance defines the only surface on said suture ring which compresses said fabric sheet between the inner surface of said suture ring and the outer surface of said valve body.

37. The rotatable artificial heart valve of claim 36, wherein there are two protuberances.

38. The rotatable artificial heart valve of claim 37, wherein the two protuberances are of differing heights.

39. The rotatable artificial heart valve of claim 37, wherein the valve body has inflow and outflow edges, and the protuberances are adjacent opposite edges.

40. The rotatable artificial heart valve of claim 36, wherein the valve body has an inflow and an outflow end, and the protuberance is adjacent one of the edges.