Selectively flexible annuloplasty ring

• US 5,104,407 A
• Filed: 09/20/1990
• Issued: 04/14/1992
• Est. Priority Date: 02/13/1989
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Lam, Hung L., Nguyen, Than, Carpentier, Alain
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Iantorno, Stephanie L.
• Application Number:
  US07/587,486
• Time in Patent Office: 572 Days
• Field of Search: 623/2
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

An annuloplasty ring prosthesis which is formed from a selectively flexible body element having at least one defined length about its circumference which is substantially rigid. The remainder of the body element gradually increases in flexibility. The body element is a substantially annular shaped body element which is designed to be sutured to the annulus of a heart valve. The body element is formed from a non-corrosive, anti-magnetic material, and is wrapped in a material through which sutures can be drawn to suture the prosthesis to the heart valve annulus.

Claims

1. An annuloplasty ring prosthesis for suturing about a hear valve annulus comprising:

a selectively flexible body member which is formed with a substantially annular shape proportioned to fit about the circumference of said heart valve annulus, said selectively flexible body member having at least one defined length which is substantially more rigid than the remainder of said selectively flexible body member, said substantially more rigid defined length comprising a portion of said member which curves upward out of a plane in which the remainder of said body member substantially lies; and

a covering surrounding said body member which is formed to permit the passage of sutures.

2. The annuloplasty ring prosthesis of claim 1 wherein said rigid length defines from about 1/8 to about 1/2 of the circumference of said selectively flexible body member.

3. The annuloplasty ring prosthesis of claim 1 wherein said body member is configured with two opposing longitudinal sides and two opposing lateral sides, with said longitudinal sides being longer than said lateral sides and said rigid length being defined along one of said longitudinal sides.

4. The annuloplasty ring prosthesis of claim 3 wherein said one of said longitudinal sides is defined by from about 1/5 to about 1/3 of the circumference of said member.

5. The annuloplasty ring prosthesis of claim 4 wherein said rigid length is defined by from about 5/8 to about 3/2 of said longitudinal side.

6. The annuloplasty ring prosthesis of claim 5 wherein said selectively flexible body member has varying degrees of stiffness as defined by a ratio of stiffness, as measured by the spring rate of said prosthesis in the longitudinal direction over the spring rate of said prosthesis in the lateral direction of from about 1.15 to about 2.77.

7. The annuloplasty ring prosthesis of claim 3 wherein said selectively flexible body member has varying degrees of stiffness as defined by a ratio of stiffness, as measured by the spring rate of said prosthesis in the longitudinal direction over the spring rate of said prosthesis in the lateral direction of from about 1.15 to about 2.77.

8. The annuloplasty ring prosthesis of claim 7 wherein said member gradually increases in flexibility about its circumference in a direction away from said defined rigid length.

30. The annuloplasty ring prosthesis of claim 1 wherein said defined rigid length is defined by from about 1/8 to about 1/2 of the circumference of said selectively flexible body member.

31. The annuloplasty ring prosthesis of claim 1 wherein said body member is configured with two opposing longitudinal sides and two opposing lateral sides with said longitudinal sides being longer than said lateral sides and said rigid length being defined along one of said longitudinal sides.

32. The annuloplasty ring prosthesis of claim 31 wherein said one of said longitudinal sides is substantially straight.

33. The annuloplasty ring prosthesis of claim 32 wherein said selectively flexible body member has varying degrees of stiffness as defined by a ratio of stiffness, as measured by the spring rate of said sides in said longitudinal direction over the spring rate of said sides in said lateral direction of from about 1.15 to about 2.77.

36. The annuloplasty ring prosthesis of claim 31 wherein said selectively flexible body member has varying degrees of stiffness as defined by a ratio of stiffness, as measured by the spring rate of said sides in said longitudinal direction over the spring rate of said sides in said lateral direction of from about 1.15 to about 2.77.

9. An annuloplasty ring prosthesis for suturing about a heart valve annulus comprising:

a selectively flexible body member which is formed with a substantially annular shape proportioned to fit about the circumference of said heart valve annulus, said flexible body member being formed from one or more individual substantially flat bands wrapped upon one another to form a multi-layered structure, said selectively flexible body member being at least one defined length which is substantially more rigid than the remainder of said body member, said defined length defined by a portion of said body member which curves upward out of a plane in which the remainder of said body member substantially lies; and

a covering surrounding said body member which is formed to permit the passage of sutures.

10. The annuloplasty ring prosthesis of claim 9 wherein said defined rigid length is defined by from about 1/8 to about 1/2 of the circumference of said member.

11. The annuloplasty ring prosthesis of claim 9 wherein said body member is configured with two opposing longitudinal and two opposing lateral sides, with the longitudinal sides being longer than the lateral sides and with said rigid length be defined by portion of one of said longitudinal sides.

12. The annuloplasty ring prosthesis of claim 9 wherein said defined rigid length, is defined by at least a part of one of said longitudinal sides, which side curves outward from said plane.

13. The annuloplasty ring prosthesis of claim 12 wherein said one of said longitudinal sides is defined by from about 1/5 to about 1/3 of the circumference of said member.

14. The annuloplasty ring prosthesis of claim 13 wherein said defined rigid length is defined by from about 5/8 to about 3/2 of said longitudinal side.

15. The annuloplasty ring prosthesis of claim 14 wherein said selectively flexible body member has varying degrees of stiffness as defined by a ratio of stiffness, as measured by the spring rate of said prosthesis in the longitudinal direction over the spring rate of said prosthesis in the lateral direction of from about 1.15 to about 2.77.

16. The annuloplasty ring prosthesis of claim 15 wherein said body member is a single wound band.

17. The annuloplasty ring prosthesis of claim 16 wherein said defined rigid length is formed by crimping or welding together a length of said individual band.

18. The annuloplasty ring prosthesis of claim 15 wherein said body member is a plurality of individual bands.

19. The annuloplasty ring prosthesis of claim 18 wherein said defined rigid length is formed by crimping or welding together a length of said individual bands.

20. The annuloplasty ring prosthesis of claim 18 wherein said member gradually increases in flexibility about its circumference in a direction away from said defined rigid length.

21. The annuloplasty ring prosthesis of claim 11 wherein said selectively flexible body member has varying degrees of stiffness as defined by a ratio of stiffness, as measured by the spring rate of said prosthesis in the longitudinal direction over the spring rate of said prosthesis in the lateral direction of from about 1.15 to about 2.77.

22. The annuloplasty ring prosthesis of claim 11 wherein said member gradually increases in flexibility about it circumference in a direction away from said defined rigid length.

23. The annuloplasty ring prosthesis of claim 9 wherein said member gradually increases in flexibility about its circumference in a direction away from said defined rigid length.

24. An annuloplasty ring prosthesis for suturing about a heart valve annulus comprising:

a selectively flexible body member formed from a plurality of individual wire strands arranged in a bundle and in a substantially annular shape proportioned to fit about the circumference of said heart valve annulus, said selectively flexible body member having at least one length which is substantially more rigid than the remainder of said selectively flexible body member as defined by fixing together said individual wire strands along said length, wherein said bundle of individual wire strands is arranged in an elastomeric tube, with the individual strands embedded in an elastomeric material held within said tube; and

a covering surrounding said selectively flexible body member which is formed to permit the passage of sutures.

25. The annuloplasty ring prosthesis of claim 24 wherein said defined rigid length is defined by from about 1/8 to about 1/2 of the circumference of said selectively flexible body.

26. The annuloplasty ring prosthesis of claim 24 wherein said body member is configured with two opposing longitudinal sides and two opposing lateral sides, with said longitudinal sides being longer than said lateral sides, and said rigid length being defined along one of said longitudinal sides.

27. The annuloplasty ring prosthesis of claim 26 wherein one of said longitudinal sides is substantially straight, and wherein said rigid length is defined by at least a part of said substantially straight longitudinal side.

28. The annuloplasty ring prosthesis of claim 27 wherein said rigid length is defined by from about 5/8 to about 3/2 of said straight longitudinal side.

29. An annuloplasty ring prosthesis for suturing about a heart valve annulus comprising:

a selectively flexible body member formed from a plurality of individual wire strands arranged in a bundle and in a substantially annular shape proportioned to fit about the circumference of said heart valve annulus, said selectively flexible body member having at least one length which is substantially more rigid than the remainder of said selectively flexible body member as defined by fixing together said individual wire strands along said length, wherein each of said individual wire strands is coated with polytetrafluoroethylene or an elastomeric material; and

a covering surrounding said selectively flexible body member which is formed to permit the passage of sutures.

34. The annuloplasty ring prosthesis of claim 29 wherein said body member is configured with a substantially straight side, said substantially straight side being defined by from about 1/5 to about 1/3 of the circumference of said member.

35. The annuloplasty ring prosthesis of claim 34 wherein said rigid length is defined by from about 5/8 to about 3/2 of said straight longitudinal side.

37. The annuloplasty ring prosthesis of claim 35 wherein said selectively flexible body member has varying degrees of stiffness as defined by a ratio of stiffness, as measured by the spring rate of said sides in said longitudinal direction over the spring rate of said sides in said lateral direction of from about 1.15 to about 2.77.

38. The annuloplasty ring prosthesis of claim 29 wherein said member gradually increases in flexibility about its circumference in a direction away from said defined rigid length.

39. An annuloplasty ring prosthesis for suturing about a heart valve annulus comprising:

a selectively flexible body member having a substantially annular shape proportional to fit about the circumference of said heart valve annulus which is formed from a multi-lumen tubular enclosure, with individual wire strands positioned individually in each of said tubular enclosure lumens, said body member being formed at one or more positions about its circumference with defined lengths which are substantially more rigid than the remainder of said body circumference, said member gradually increasing in flexibility about its circumference in a direction away from each of said defined rigid lengths; and

means associated with said body member for enclosing said tubular structure, which is formed to permit suturing of said ring prosthesis about said heart valve.

40. The annuloplasty ring prosthesis of claim 39 wherein said prosthesis member includes only one of said defined rigid lengths, which is defined by from about 1/8 to about 1/2 of the circumference of said member.

41. The annuloplasty ring prosthesis of claim 39 wherein said body member is dimensioned to be longer in a longitudinal direction than in a lateral direction, with said member being stiffer in said longitudinal direction.

42. The annuloplasty ring prosthesis of claim 41 wherein a portion of one side of said body member along said longitudinal direction is substantially straight, and wherein said prosthesis member includes only one of said defined rigid lengths, with said defined rigid length being defined by at least a part of said straight side.

43. The annuloplasty ring prosthesis of claim 42 wherein said straight side is defined by the from about 1/5 to about 1/3 of the circumference of said member.

44. The annuloplasty ring prosthesis of claim 43 wherein said defined rigid length is defined by from about 5/8 to about 3/2 of said straight side.

45. The annuloplasty ring prosthesis of claim 44 wherein said selectively flexible body member has varying degrees of stiffness as defined by a ratio of stiffness, as measured by the spring rate of said prosthesis in the longitudinal direction over the spring rate of said prosthesis in the lateral direction of from about 1.15 to about 2.77.

46. The annuloplasty ring prosthesis of claim 45 wherein said defined rigid length is formed by positioning a malleable material around a portion of said body member which is to define said rigid length, and pinching said material down upon said body.

47. The annuloplasty ring prosthesis of claim 46 wherein said malleable material is pinched down upon said body member after a portion of said multi-lumen tube is removed to expose said wire strands.

48. The annuloplasty ring prosthesis of claim 42 wherein said selectively flexible body member has varying degrees of stiffness as defined by a ratio of stiffness, as measured by the spring rate of said prosthesis in the longitudinal direction over the spring rate of said prosthesis in the lateral direction of from about 1.15 to about 2.77.

49. The annuloplasty ring prosthesis of claim 41 wherein said selectively flexible body member has varying degrees of stiffness as defined by a ratio of stiffness, as measured by the spring rate of said prosthesis in the longitudinal direction over the spring rate of said prosthesis in the lateral direction of from about 1.15 to about 2.77.