Shape memory annuloplasty ring and holder

• US 20060100697A1
• Filed: 11/10/2004
• Published: 05/11/2006
• Est. Priority Date: 11/10/2004
• Status: Abandoned Application

• Current Assignee: Carbomedics Inc. (Snia SpA)
• Original Assignee: Carbomedics Inc. (Snia SpA)
• Inventors: Casanova, R. Michael
• Application Number:
  US10/985,491
• Publication Number:
  US 20060100697A1
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation

Abstract

An annuloplasty ring includes an elastomeric member, a shape memory member, and an outer wrap covering the elastomeric member. The shape memory member is disposed in the elastomeric member and enables the annuloplasty ring to exhibit a compressed form and an expanded form depending on the temperature of the shape memory member. A method of training an annuloplasty ring includes bringing a shape memory member of the annuloplasty ring to a temperature above its transformation temperature range and plastically deforming the shape memory member into its expanded shape. The method further includes bringing the shape memory member to a temperature below its transformation temperature range and plastically deforming the shape memory member into its compressed shape.

Claims

1. An annuloplasty ring, comprising:

an elastomeric member;

a shape memory member disposed in the elastomeric member enabling the annuloplasty ring to exhibit a compressed form and an expanded post implant form that is suitable for providing a desired flexibility in the annuloplasty ring after implantation depending on the temperature of the shape memory member; and

an outer wrap covering the elastomeric member.

2. An annuloplasty ring, according to claim 1, wherein the elastomeric member comprises one of a medical grade rubber and a silicone rubber.

3. An annuloplasty ring, according to claim 1, wherein the shape memory member comprises one of:

a binary alloy of titanium and nickel;

nitinol;

an alloy comprising nickel, titanium, and one of niobium, iron, copper, and manganese;

a titanium/molybdenum alloy; and

a shape memory polymer.

4. An annuloplasty ring, according to claim 3, wherein the shape memory polymer comprises a phase segregated linear block co-polymer including a hard block having a melting point or glass transition temperature greater than that of a soft block.

5. An annuloplasty ring, according to claim 4, wherein the phase segregated linear block co-polymer includes one of a polyether, a polyacrylate, a polyamide, a polysiloxane, a polyurethane, a polyether amide, a polyurethane/urea, a polyether ester, and a urethane/butadiene copolymer.

6. An annuloplasty ring, according to claim 1, wherein the shape memory member comprises a material that changes between a first solid-state phase and a second solid-state phase within a temperature range below about 32°

C.

7. An annuloplasty ring, according to claim 6, wherein the shape memory member exhibits its compressed form in the first solid-state phase and exhibits its expanded form in the second solid-state phase.

8. An annuloplasty ring, according to claim 1, wherein the outer wrap comprises a knitted polyester fabric.

9. An annuloplasty ring, according to claim 1, wherein the outer wrap comprises an agent for improving a biological compatibility of the annuloplasty ring or for decreasing the likelihood of thrombogenesis.

10. An annuloplasty ring, according to claim 1, wherein the annuloplasty ring comprises a first end and a second end proximate the first end.

11. An annuloplasty ring, according to claim 1, wherein the shape memory member is generally rectangular in cross-section.

12. An annuloplasty ring, according to claim 1, wherein the shape memory member is generally C-shaped in cross-section.

13. An annuloplasty ring, according to claim 1, wherein the shape memory member exhibits a transformation temperature range that is below about 32°

C.

14. An annuloplasty ring, according to claim 1, wherein the annuloplasty ring is generally planar.

15. An annuloplasty ring, according to claim 1, further comprising a sewing cuff.

16. An annuloplasty ring, comprising:

an elastomeric member;

a shape memory member disposed in the elastomeric member enabling the annuloplasty ring to exhibit a compressed form and an expanded post implant form that is suitable for providing a desired flexibility in the annuloplasty ring after implantation depending on the temperature of the shape memory member;

an outer wrap covering the elastomeric member; and

a first end and a second end spaced apart from the first end.

17. An annuloplasty ring, according to claim 16, wherein the shape memory member comprises one of:

a binary alloy of titanium and nickel;

nitinol;

an alloy comprising nickel, titanium, and one of niobium, iron, copper, and manganese;

a titanium/molybdenum alloy; and

a shape memory polymer.

18. An annuloplasty ring, according to claim 17, wherein the shape memory polymer comprises a phase segregated linear block co-polymer including a hard block having a melting point or glass transition temperature greater than that of a soft block.

19. An annuloplasty ring, according to claim 18, wherein the phase segregated linear block co-polymer includes one of a polyether, a polyacrylate, a polyamide, a polysiloxane, a polyurethane, a polyether amide, a polyurethane/urea, a polyether ester, and a urethane/butadiene copolymer.

20. An annuloplasty ring, according to claim 16, wherein the shape memory member comprises a material that changes between a first solid-state phase and a second solid-state phase within a temperature range below about 32°

C.

21. An annuloplasty ring, according to claim 20, wherein the shape memory member exhibits its compressed form in the first solid-state phase and exhibits its expanded form in the second solid-state phase.

22. An annuloplasty ring, according to claim 16, wherein the shape memory member is generally rectangular in cross-section.

23. An annuloplasty ring, according to claim 16, wherein the shape memory member is generally C-shaped in cross-section.

24. An annuloplasty ring, according to claim 16, wherein the shape memory member exhibits a transformation temperature range that is below about 32°

C.

25. An annuloplasty ring, according to claim 16, wherein the annuloplasty ring is generally planar.

26. An annuloplasty ring, according to claim 16, wherein the annuloplasty ring is generally saddle shaped.

27. An annuloplasty ring, according to claim 16, further comprising a sewing cuff.

28. An annuloplasty ring, comprising:

an elastomeric member;

a shape memory member disposed in the elastomeric member enabling the annuloplasty ring to exhibit a compressed form and an expanded post implant form that is suitable for providing a desired flexibility in the annuloplasty ring after implantation depending on the temperature of the shape memory member, wherein the annuloplasty ring exhibits a saddle shape in its expanded form; and

an outer wrap covering the elastomeric member.

29. An annuloplasty ring, according to claim 28, wherein the shape memory member comprises one of:

a binary alloy of titanium and nickel;

nitinol;

an alloy comprising nickel, titanium, and one of niobium, iron, copper, and manganese;

a titanium/molybdenum alloy; and

a shape memory polymer.

30. An annuloplasty ring, according to claim 29, wherein the shape memory polymer comprises a phase segregated linear block co-polymer including a hard block having a melting point or glass transition temperature greater than that of a soft block.

31. An annuloplasty ring, according to claim 30, wherein the phase segregated linear block co-polymer includes one of a polyether, a polyacrylate, a polyamide, a polysiloxane, a polyurethane, a polyether amide, a polyurethane/urea, a polyether ester, and a urethane/butadiene copolymer.

32. An annuloplasty ring, according to claim 28, wherein the shape memory member comprises a material that changes between a first solid-state phase and a second solid-state phase within a temperature range below about 32°

C.

33. An annuloplasty ring, according to claim 32, wherein the shape memory member exhibits its compressed form in the first solid-state phase and exhibits its expanded form in the second solid-state phase.

34. An annuloplasty ring, according to claim 28, wherein the shape memory member is generally rectangular in cross-section.

35. An annuloplasty ring, according to claim 28, wherein the shape memory member is generally C-shaped in cross-section.

36. An annuloplasty ring, according to claim 28, wherein the shape memory member exhibits a transformation temperature range that is below about 32°

C.

37. An annuloplasty apparatus, comprising:

an annuloplasty ring, including;

an elastomeric member;

a shape memory member disposed in the elastomeric member enabling the annuloplasty ring to exhibit a compressed form and an expanded post implant form that is suitable for providing a desired flexibility in the annuloplasty ring after implantation depending on the temperature of the shape memory member;

an outer wrap covering the elastomeric member, and

a holder comprising a handle, a head defining a groove, and a stem extending between the handle and the head, such that the annuloplasty ring, in its compressed form, is retained in the groove.

38. An annuloplasty apparatus, according to claim 37, wherein the head is generally cylindrical in shape.

39. An annuloplasty apparatus, according to claim 37, wherein the shape memory member comprises one of:

a binary alloy of titanium and nickel;

nitinol;

an alloy comprising nickel, titanium, and one of niobium, iron, copper, and manganese;

a titanium/molybdenum alloy; and

a shape memory polymer.

40. An annuloplasty apparatus, according to claim 37, wherein the head comprises a frustoconical head having a smaller diameter at a forward end thereof than proximate the stem.

41. An annuloplasty apparatus, according to claim 37, wherein the head comprises a frustoconical head having a larger diameter at a forward end thereof than proximate the stem.

42. A method of training an annuloplasty ring, comprising:

forming an annuloplasty ring comprising;

an elastomeric member;

a shape memory member disposed in the elastomeric member enabling the annuloplasty ring to exhibit a compressed form and an expanded post implant form that is suitable for providing a desired flexibility in the annuloplasty ring after implantation depending upon the temperature of the shape memory member; and

an outer wrap covering the elastomeric member;

bringing the shape memory member of the annuloplasty ring to a temperature above its transformation temperature range;

plastically deforming the shape memory member into its expanded shape;

bringing the shape memory member to a temperature below its transformation temperature range; and

plastically deforming the shape memory member into its compressed shape.

43. A method, according to claim 42, wherein plastically deforming the shape memory member into its expanded shape comprises plastically deforming the shape memory member into a generally planar shape.

44. A method, according to claim 42, wherein plastically deforming the shape memory member into its expanded shape comprises plastically deforming the shape memory member into a saddle shape.

45. A method, according to claim 42, wherein plastically deforming the shape memory member into its expanded shape comprises plastically deforming the shape memory member such that ends of the annuloplasty ring are adjacent.

46. A method, according to claim 42, wherein plastically deforming the shape memory member into its expanded shape comprises plastically deforming the shape memory member such that ends of the annuloplasty ring are spaced apart.

47. A method, according to claim 42, wherein plastically deforming the shape memory member into its compressed shape comprises plastically deforming the shape memory member so that it may be retained on a holder.

48. A method, according to claim 42, further comprising retaining the annuloplasty ring, in its compressed form, on a holder.

49. A method, according to claim 42, wherein the transformation temperature range is below about 32°

C.

50. A method of using an annuloplasty ring including a shape memory member, comprising:

positioning the annuloplasty ring in a compressed form on a holder;

inserting the annuloplasty ring in its compressed form into a patient'"'"'s body; and

using heat from the patient'"'"'s body to allow a temperature of the annuloplasty ring to increase above the shape memory member'"'"'s transformation temperature range to expand the annuloplasty ring into an expanded post implant form that is suitable for providing a desired flexibility in the annuloplasty ring after implantation.

51. A method, according to claim 50, wherein the transformation temperature range is below about 32°

C.

52. A method, according to claim 50, wherein inserting the annuloplasty ring further comprises inserting the annuloplasty ring through a small incision or access port.