Cardiac valve implant with energy absorbing material

• US 7,396,364 B2
• Filed: 05/06/2005
• Issued: 07/08/2008
• Est. Priority Date: 06/29/2004
• Status: Expired due to Fees

• Current Assignee: MiCardia Corporation
• Original Assignee: MiCardia Corporation
• Inventors: Shaolian, Samuel M., Moaddeb, Shahram, Shaoulian, Emanuel
• Primary Examiner(s): Gherbi; Suzette J
• Application Number:
  US11/124,409
• Publication Number:
  US 20050288782A1
• Time in Patent Office: 1,159 Days
• Field of Search: 623 236- 242
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0082 specially designed for children, e.g. having means for adjusting to their growth

Abstract

Methods and devices are provided for support of a body structure. The devices can be adjusted within the body of a patient in a minimally invasive or non-invasive manner such as by applying energy percutaneously or external to the patient'"'"'s body. The energy may include, for example, acoustic energy, radio frequency energy, light energy and magnetic energy. Thus, as the body structure changes size and/or shape, the size and/or shape of the annuloplasty rings can be adjusted to provide continued reinforcement. In certain embodiments, the devices include a body member including a shape memory material, and an energy absorption enhancement material configured to absorb energy in response to an activation energy. The energy absorption enhancement material is in thermal communication with said shape memory material. The body member has a first size of a dimension in a first configuration and a second size of the dimension in a second configuration, and is configured to be implanted in the first configuration into a heart. The body member is configured to transform from the first configuration to the second configuration in response to the activation energy. The second configuration is configured to reduce a dimension of a cardiac valve annulus in the heart.

Claims

1. An adjustable annuloplasty device comprising:

a body member comprising a shape memory material;

an energy absorption enhancement material configured to absorb energy in response to a first activation energy, said energy absorption enhancement material in thermal communication with said shape memory material;

wherein said body member has a first size of a body dimension in a first configuration and a second size of said body dimension in a second configuration;

wherein said body member is configured to be implanted in said first configuration into a heart;

wherein said body member is configured to transform from said first configuration to said second configuration in response to said first activation energy;

wherein said second configuration is configured to reduce a dimension of a cardiac valve annulus in said heart;

wherein said body member has a third size of said body dimension in a third configuration;

wherein said third size is larger than said second size; and

wherein said body member is configured to transform to said third configuration in response to a second activation energy to increase said dimension of said cardiac valve annulus.

2. The adjustable annuloplasty device of claim 1, wherein the first activation energy is at least one of thermal energy, light energy, magnetic energy, radio frequency energy, acoustic energy, and electrical energy.

3. The adjustable annuloplasty device of claim 1, wherein said energy absorption enhancement material is further configured to heat in response to said first activation energy.

4. The adjustable annuloplasty device of claim 3, wherein said energy absorption enhancement material is configured to transfer heat to said shape memory material.

5. The adjustable annuloplasty device of claim 1, wherein said shape memory material comprises at least one of a metal, a metal alloy, a nickel titanium alloy, a shape memory polymer, polylactic acid, and polyglycolic acid.

6. The adjustable annuloplasty device of claim 1, further comprising an electrically conductive material configured to conduct a current in response to said first activation energy and to transfer thermal energy to said shape memory material.

7. The adjustable annuloplasty device of claim 1, further comprising a suturable material configured to facilitate attachment of said body member to said cardiac valve annulus.

8. The adjustable annuloplasty device of claim 1, wherein the first activation energy is effective to heat the shape memory material to a temperature in a range from about 38°

C. to about 60°

C.

9. The adjustable annuloplasty device of claim 1, wherein the first activation energy is effective to heat the shape memory material to a temperature in a range from about 40°

C. to about 55°

C.

10. An adjustable annuloplasty device comprising:

a body member comprising a shape memory material;

an energy absorption enhancement material configured to absorb energy in response to a first activation energy, said energy absorption enhancement material in thermal communication with said shape memory material;

wherein said body member has a first size of a body dimension in a first configuration and a second size of said body dimension in a second configuration;

wherein said body member is configured to be implanted in said first configuration into a heart;

wherein said body member is configured to transform from said first configuration to said second configuration in response to said first activation energy;

wherein said second configuration is configured to reduce a dimension of a cardiac valve annulus in said heart;

wherein said body member has a third size of said body dimension in a third configuration;

wherein said third size is smaller than said second size; and

wherein said body member is configured to transform to said third configuration in response to a second activation energy to decrease said dimension of said cardiac valve annulus.

11. The adjustable annuloplasty device of claim 10, wherein the first activation energy is at least one of thermal energy, light energy, magnetic energy, radio frequency energy, acoustic energy, and electrical energy.

12. The adjustable annuloplasty device of claim 10, wherein said energy absorption enhancement material is further configured to heat in response to said first activation energy.

13. The adjustable annuloplasty device of claim 12, wherein said energy absorption enhancement material is configured to transfer heat to said shape memory material.

14. The adjustable annuloplasty device of claim 10, wherein said shape memory material comprises at least one of a metal, a metal alloy, a nickel titanium alloy, a shape memory polymer, polylactic acid, and polyglycolic acid.

15. The adjustable annuloplasty device of claim 10, further comprising an electrically conductive material configured to conduct a current in response to said first activation energy and to transfer thermal energy to said shape memory material.

16. The adjustable annuloplasty device of claim 10, further comprising a suturable material configured to facilitate attachment of said body member to said cardiac valve annulus.

17. The adjustable annuloplasty device of claim 10, wherein the first activation energy is effective to heat the shape memory material to a temperature in a range from about 38°

C. to about 60°

C.

18. The adjustable annuloplasty device of claim 10, wherein the first activation energy is effective to heat the shape memory material to a temperature in a range from about 40°

C. to about 55°

C.

19. An adjustable annuloplasty device comprising:

a body member comprising a shape memory material;

an energy absorption enhancement material configured to absorb energy in response to a first activation energy, said energy absorption enhancement material in thermal communication with said shape memory material;

wherein said body member has a first size of a body dimension in a first configuration and a second size of said body dimension in a second configuration;

wherein said body member is configured to be implanted in said first configuration into a heart;

wherein said body member is configured to transform from said first configuration to said second configuration in response to said first activation energy;

wherein said second configuration is configured to reduce a dimension of a cardiac valve annulus in said heart;

wherein said energy absorption enhancement material comprises a nanoparticle.

20. The adjustable annuloplasty device of claim 19, wherein said nanoparticle comprises at least one of a nanoshell and a nanosphere.

21. The adjustable annuloplasty device of claim 19, wherein the first activation energy is at least one of thermal energy, light energy, magnetic energy, radio frequency energy, acoustic energy, and electrical energy.

22. The adjustable annuloplasty device of claim 19, wherein said energy absorption enhancement material is further configured to heat in response to said first activation energy.

23. The adjustable annuloplasty device of claim 22, wherein said energy absorption enhancement material is configured to transfer heat to said shape memory material.

24. The adjustable annuloplasty device of claim 19, wherein said shape memory material comprises at least one of a metal, a metal alloy, a nickel titanium alloy, a shape memory polymer, polylactic acid, and polyglycolic acid.

25. The adjustable annuloplasty device of claim 19, further comprising an electrically conductive material configured to conduct a current in response to said first activation energy and to transfer thermal energy to said shape memory material.

26. The adjustable annuloplasty device of claim 19, further comprising a suturable material configured to facilitate attachment of said body member to said cardiac valve annulus.

27. The adjustable annuloplasty device of claim 19, wherein the first activation energy is effective to heat the shape memory material to a temperature in a range from about 38°

C. to about 60°

C.

28. The adjustable annuloplasty device of claim 19, wherein the first activation energy is effective to heat the shape memory material to a temperature in a range from about 40°

C. to about 55°

C.

29. An adjustable annuloplasty device comprising:

a body member comprising a shape memory material;

an energy transfer material configured to transfer energy in response to a first activation energy, said energy transfer material in thermal communication with said shape memory material;

wherein said body member has a first size of a body dimension in a first configuration and a second size of said body dimension in a second configuration;

wherein said body member is configured to be implanted in said first configuration into a heart;

wherein said body member is configured to transform from said first configuration to said second configuration in response to said first activation energy;

wherein said second configuration is configured to reduce a dimension of a cardiac valve annulus in said heart;

wherein said body member has a third size of said body dimension in a third configuration;

wherein said third size is larger than said second size; and

wherein said body member is configured to transform to said third configuration in response to a second activation energy to increase said dimension of said cardiac valve annulus.

30. The adjustable annuloplasty device of claim 29, wherein the first activation energy is at least one of thermal energy, light energy, magnetic energy, radio frequency energy, acoustic energy, and electrical energy.

31. The adjustable annuloplasty device of claim 29, wherein said energy absorption enhancement material is further configured to heat in response to said first activation energy.

32. The adjustable annuloplasty device of claim 31, wherein said energy absorption enhancement material is configured to transfer heat to said shape memory material.

33. The adjustable annuloplasty device of claim 29, wherein said shape memory material comprises at least one of a metal, a metal alloy, a nickel titanium alloy, a shape memory polymer, polylactic acid, and polyglycolic acid.

34. The adjustable annuloplasty device of claim 29, further comprising an electrically conductive material configured to conduct a current in response to said first activation energy and to transfer thermal energy to said shape memory material.

35. The adjustable annuloplasty device of claim 29, further comprising a suturable material configured to facilitate attachment of said body member to said cardiac valve annulus.

36. The adjustable annuloplasty device of claim 29, wherein the first activation energy is effective to heat the shape memory material to a temperature in a range from about 38°

C. to about 60°

C.

37. The adjustable annuloplasty device of claim 29, wherein the first activation energy is effective to heat the shape memory material to a temperature in a range from about 40°

C. to about 55°

C.

38. An adjustable annuloplasty device comprising:

a body member comprising a shape memory material;

an energy transfer material configured to transfer energy in response to a first activation energy, said energy transfer material in thermal communication with said shape memory material;

wherein said body member has a first size of a body dimension in a first configuration and a second size of said body dimension in a second configuration;

wherein said body member is configured to be implanted in said first configuration into a heart;

wherein said body member is configured to transform from said first configuration to said second configuration in response to said first activation energy;

wherein said second configuration is configured to reduce a dimension of a cardiac valve annulus in said heart;

wherein said body member has a third size of said body dimension in a third configuration;

wherein said third size is smaller than said second size; and

wherein said body member is configured to transform to said third configuration in response to a second activation energy to decrease said dimension of said cardiac valve annulus.

39. The adjustable annuloplasty device of claim 38, wherein the first activation energy is at least one of thermal energy, light energy, magnetic energy, radio frequency energy, acoustic energy, and electrical energy.

40. The adjustable annuloplasty device of claim 38, wherein said energy absorption enhancement material is further configured to heat in response to said first activation energy.

41. The adjustable annuloplasty device of claim 40, wherein said energy absorption enhancement material is configured to transfer heat to said shape memory material.

42. The adjustable annuloplasty device of claim 38, wherein said shape memory material comprises at least one of a metal, a metal alloy, a nickel titanium alloy, a shape memory polymer, polylactic acid, and polyglycolic acid.

43. The adjustable annuloplasty device of claim 38, further comprising an electrically conductive material configured to conduct a current in response to said first activation energy and to transfer thermal energy to said shape memory material.

44. The adjustable annuloplasty device of claim 38, further comprising a suturable material configured to facilitate attachment of said body member to said cardiac valve annulus.

45. The adjustable annuloplasty device of claim 38, wherein the first activation energy is effective to heat the shape memory material to a temperature in a range from about 38°

C. to about 60°

C.

46. The adjustable annuloplasty device of claim 38, wherein the first activation energy is effective to heat the shape memory material to a temperature in a range from about 40°

C. to about 55°

C.

47. An adjustable annuloplasty device comprising:

a body member comprising a shape memory material;

an energy transfer material configured to transfer energy in response to a first activation energy, said energy transfer material in thermal communication with said shape memory material;

wherein said body member has a first size of a body dimension in a first configuration and a second size of said body dimension in a second configuration;

wherein said body member is configured to be implanted in said first configuration into a heart;

wherein said body member is configured to transform from said first configuration to said second configuration in response to said first activation energy;

wherein said second configuration is configured to reduce a dimension of a cardiac valve annulus in said heart;

wherein said energy transfer material comprises a nanoparticle.

48. The adjustable annuloplasty device of claim 47, wherein said nanoparticle comprises at least one of a nanoshell and a nanosphere.

49. The adjustable annuloplasty device of claim 47, wherein the first activation energy is at least one of thermal energy, light energy, magnetic energy, radio frequency energy, acoustic energy, and electrical energy.

50. The adjustable annuloplasty device of claim 47, wherein said energy absorption enhancement material is further configured to heat in response to said first activation energy.

51. The adjustable annuloplasty device of claim 50, wherein said energy absorption enhancement material is configured to transfer heat to said shape memory material.

52. The adjustable annuloplasty device of claim 47, wherein said shape memory material comprises at least one of a metal, a metal alloy, a nickel titanium alloy, a shape memory polymer, polylactic acid, and polyglycolic acid.

53. The adjustable annuloplasty device of claim 47, further comprising an electrically conductive material configured to conduct a current in response to said first activation energy and to transfer thermal energy to said shape memory material.

54. The adjustable annuloplasty device of claim 47, further comprising a suturable material configured to facilitate, attachment of said body member to said cardiac valve annulus.

55. The adjustable annuloplasty device of claim 47, wherein the first activation energy is effective to heat the shape memory material to a temperature in a range from about 38°

C. to about 60°

C.

56. The adjustable annuloplasty device of claim 47, wherein the first activation energy is effective to heat the shape memory material to a temperature in a range from about 40°

C. to about 55°

C.