ADJUSTABLE CARDIAC VALVE IMPLANT WITH SELECTIVE DIMENSIONAL ADJUSTMENT

• US 20080183285A1
• Filed: 02/14/2008
• Published: 07/31/2008
• Est. Priority Date: 06/29/2004
• Status: Abandoned Application

• Current Assignee: MiCardia Corporation
• Original Assignee: MiCardia Corporation
• Inventors: Moaddeb, Shahram, Shaoulian, Emanuel, Rhee, Richard S., Shaolian, Samuel
• Application Number:
  US12/031,652
• Publication Number:
  US 20080183285A1
• Time in Patent Office: Days
• US Class Current: 623/2.37
• 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 2210/009 magnetic
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0004 adjustable

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 an anterior portion, a posterior portion and two lateral portions corresponding to intersections of the anterior portion and the posterior portion. The devices have a first shape in a first configuration and a second shape in a second configuration and are configured to transform from the first configuration to the second configuration in response to an activation energy applied thereto. The transformation is configured to reduce a distance between the anterior portion and the posterior portion more than a distance between the two lateral portions.

Claims

1. An annuloplasty device configured to support a heart valve, said annuloplasty device comprising:

a body comprising;

an anterior portion;

a posterior portion;

two lateral portions corresponding to intersections of said anterior portion and said posterior portion;

wherein said annuloplasty device has a first shape in a first configuration and a second shape in a second configuration;

wherein said annuloplasty device is configured to transform from said first configuration to said second configuration in response to a first activation energy applied thereto; and

wherein said transformation is configured to reduce a first distance, between said anterior portion and said posterior portion, more than a second distance, between said two lateral portions, is reduced.

2. The annuloplasty device of claim 1, wherein the reduction in the second distance is no more than about 15%.

3. The annuloplasty device of claim 1, wherein the reduction in the second distance is no more than about 10%.

4. The annuloplasty device of claim 1, wherein the reduction in the second distance is no more than about 5%.

5. The annuloplasty device of claim 1, wherein the second distance is increased in response to the first activation energy.

6. The annuloplasty device of claim 1, wherein the reduction in the first distance is at least about 15%, and wherein the reduction in the second distance is no more than about 10%.

7. The annuloplasty device of claim 1, wherein the reduction in the first distance is at least about 15%, and wherein the reduction in the second distance is no more than about 5%.

8. The annuloplasty device of claim 1, wherein the reduction in the second distance is no more than about 3 mm.

9. The annuloplasty device of claim 1, wherein the reduction in the second distance is no more than about 2 mm.

10. The annuloplasty device of claim 1, wherein the reduction in the second distance is no more than about 1 mm.

11. The annuloplasty device of claim 1, further comprising a first shape memory element and a second shape memory element, the first and second shape memory elements being separated by an insulative segment.

12. The annuloplasty device of claim 11, wherein the insulative segment is configured to insulate said second shape memory element from the first shape memory element, such that upon application of the first activation energy to said first shape memory element, the second shape memory element does not substantially change shape.

13. The annuloplasty device of claim 1, further comprising one or more imaging markers.

14. The annuloplasty device of claim 13, wherein said one or more imaging markers comprise a radiopaque marker.

15. The annuloplasty device of claim 1, further comprising:

a wire that extends at least partially along said anterior and posterior portions; and

a first shape memory member at least partially covering or contacting said wire.

16. The annuloplasty device of claim 15, wherein said wire is selected from the group consisting of a round wire, a flat wire, a mesh wire, a rod-shaped wire, and a band-shaped wire.

17. The annuloplasty device of claim 15, wherein said first shape memory member comprises a tubular structure, and wherein at least a portion of said wire passes through said tubular structure.

18. The annuloplasty device of claim 17, wherein said tubular structure comprises a first shape memory body configured to respond to said first activation energy by bending said wire such that said annuloplasty device transforms from said first shape to said second shape.

19. The annuloplasty device of claim 17, wherein said tubular structure further comprises a second shape memory body configured to respond to a second activation energy by bending said wire such that said annuloplasty device transforms from said second shape to a third shape.

20. The annuloplasty device of claim 19, wherein said annuloplasty device in said third shape has a reduced first distance as compared to said second shape.

21. The annuloplasty device of claim 19, wherein said annuloplasty device in said third shape has an increased first distance as compared to said second shape.

22. The annuloplasty device of claim 19, wherein at least one of said first activation energy and said second activation energy comprises at least one of a magnetic field, an acoustic energy, and a radio frequency energy.

23. The annuloplasty device of claim 19, wherein said first shape memory body changes to a first activation temperature in response to said first activation energy, and wherein said second shape memory body changes to a second activation temperature in response to said second activation energy.

24. The annuloplasty device of claim 23, wherein said first activation temperature is lower than said second activation temperature.

25. The annuloplasty device of claim 1, wherein said first activation energy comprises at least one of a magnetic field, an acoustic energy, and a radio frequency energy.

26. The annuloplasty device of claim 1, further comprising a first shape memory band that extends at least partially along said anterior and posterior portions.

27. The annuloplasty device of claim 26, wherein said first shape memory band folds back on itself in a curvilinear configuration such that different portions of said first shape memory band overlap one another.

28. The annuloplasty device of claim 27, wherein said first shape memory band is configured to change its length in response to said first activation energy such that said overlapping portions slide with respect to one another to change said annuloplasty device from said first configuration to said second configuration.

29. The annuloplasty device of claim 28, further comprising a second shape memory band at least partially disposed between or adjacent to said overlapping portions of said first shape memory band.

30. The annuloplasty device of claim 29, wherein said second shape memory band is configured to respond to a second activation energy to transform said annuloplasty device from said second configuration to a third configuration.

31. The annuloplasty device of claim 30, wherein said annuloplasty device in said third configuration has a reduced first distance as compared to said second shape.

32. The annuloplasty device of claim 30, wherein said annuloplasty device in said third configuration has an increased first distance as compared to said second shape.

33. The annuloplasty device of claim 30, wherein at least one of said first activation energy and said second activation energy comprises at least one of a magnetic field, an acoustic energy, and a radio frequency energy.

34. The annuloplasty device of claim 30, wherein said first shape memory band changes to a first activation temperature in response to said first activation energy, and wherein said second shape memory band changes to a second activation temperature in response to said second activation energy.

35. The annuloplasty device of claim 34, wherein said first activation temperature is lower than said second activation temperature.

36. An annuloplasty device comprising:

a elongate member comprising;

an anterior portion;

a posterior portion; and

two lateral portions corresponding to intersections of said anterior portion and said posterior portion; and

a first shape memory member at least partially covering or contacting said elongate member;

wherein said first shape memory member is configured to respond to a first activation energy applied thereto by reducing a first distance, between said anterior portion and said posterior portion, more than a second distance, between said two lateral portions.

37. The annuloplasty device of claim 36, wherein the reduction in the second distance is no more than about 15%.

38. The annuloplasty device of claim 36, wherein the second distance increases in response to the first activation energy.

39. The annuloplasty device of claim 36, wherein the reduction in the first distance is at least about 15%, and wherein the reduction in the second distance is no more than about 10%.

40. The annuloplasty device of claim 36, wherein the reduction in the second distance is no more than about 3 mm.

41. The annuloplasty device of claim 36, wherein said elongate member is selected from the group consisting of a round wire, a flat wire, a mesh wire, a rod-shaped wire, and a band-shaped wire.

42. The annuloplasty device of claim 36, wherein said first shape memory member comprises a tubular structure, and wherein at least a portion of said elongate member passes through said tubular structure.

43. The annuloplasty device of claim 42, wherein said tubular structure comprises a first shape memory body configured to respond to said first activation energy by bending said elongate member from a first shape to a second shape.

44. The annuloplasty device of claim 42, wherein said tubular structure further comprises a second shape memory body configured to respond to a second activation energy by bending said elongate member from said second shape to a third shape.

45. An annuloplasty device comprising:

a first shape memory band comprising;

an anterior portion;

a posterior portion; and

two lateral portions corresponding to intersections of said anterior portion and said posterior portion;

wherein said first shape memory band loops back on itself in a curvilinear configuration such that portions of said first shape memory band overlap one another; and

wherein said first shape memory band is configured to respond to a first activation energy applied thereto by reducing a first distance, between said anterior portion and said posterior portion, more than a second distance, between said two lateral portions.

46. The annuloplasty device of claim 45, wherein the reduction in the second distance is no more than about 15%.

47. The annuloplasty device of claim 45, wherein the second distance increases in response to the first activation energy.

48. The annuloplasty device of claim 45, wherein the reduction in the second distance is no more than about 3 mm.

49. The annuloplasty device of claim 45, wherein said first shape memory band is configured to change its length in response to said first activation energy, such that said overlapping portions slide with respect to one another to change said annuloplasty device from a first configuration to a second configuration.

50. An annuloplasty device comprising:

an elongate member defining an anteroposterior dimension and a lateral dimension;

adjustment means for changing a patient'"'"'s cardiac valve annulus size in the anteroposterior dimension more than changing said annulus in the lateral dimension; and

wherein the changing occurs in response to a transmission of energy from a non-invasive source external to the patient'"'"'s heart to said adjustment means.

51. An annuloplasty device that changes a patient'"'"'s cardiac valve annulus size in an anteroposterior dimension more than changing said annulus in a lateral dimension, wherein the changing occurs in response to a transmission of energy from a non-invasive source, external to the patient'"'"'s heart, to said annuloplasty device.

52. An annuloplasty device configured to support a heart valve, said annuloplasty device comprising:

an anterior portion;

a posterior portion;

two lateral portions corresponding to intersections of said anterior portion and said posterior portion;

wherein said annuloplasty device has a first shape in a first configuration and a second shape in a second configuration;

wherein said annuloplasty device is configured to transform from said first configuration to said second configuration in response to a first activation energy applied thereto; and

wherein said transformation is configured to reduce a first distance, between said two lateral portions, more than a second distance, between said anterior portion and said posterior portion.

53. The annuloplasty device of claim 52, wherein the reduction in the second distance is no more than about 15%.

54. The annuloplasty device of claim 52, wherein the second distance increases in response to the first activation energy.

55. The annuloplasty device of claim 52, wherein the reduction in the first distance is at least about 15%, and wherein the reduction in the second distance is no more than about 10%.

56. The annuloplasty device of claim 52, wherein the reduction in the second distance is no more than about 3 mm.

57. An annuloplasty device comprising:

an elongate member comprising;

an anterior portion;

a posterior portion; and

two lateral portions corresponding to intersections of said anterior portion and said posterior portion; and

a first shape memory member at least partially covering or contacting said elongate member;

wherein said first shape memory member is configured to respond to a first activation energy applied thereto by reducing a first distance, between said two lateral portions, more than a second distance, between said anterior portion and said posterior portion.

58. The annuloplasty device of claim 57, wherein the reduction in the second distance is no more than about 15%.

59. An annuloplasty device comprising:

a first shape memory band comprising;

an anterior portion;

a posterior portion; and

two lateral portions corresponding to intersections of said anterior portion and said posterior portion;

wherein said first shape memory band loops back on itself in a curvilinear configuration such that portions of said first shape memory band overlap one another; and

wherein said first shape memory band is configured to respond to a first activation energy applied thereto by reducing a first distance, between said two lateral portions, more than a second distance, between said anterior portion and said posterior portion.

60. An annuloplasty device comprising:

an body defining a lateral dimension and an anteroposterior dimension;

adjustment means for changing a patient'"'"'s cardiac valve annulus size in the lateral dimension more than changing said annulus in the anteroposterior dimension; and

wherein the changing occurs in response to a transmission of energy from a non-invasive source external to the patient'"'"'s heart to said adjustment means.

61. An annuloplasty device that changes a patient'"'"'s cardiac valve annulus size in a lateral dimension more than changing said annulus in an anteroposterior dimension, wherein the changing occurs in response to a transmission of energy from a non-invasive source, external to the patient'"'"'s heart, to said annuloplasty device.