Adjustable cardiac valve implant with selective dimensional adjustment

• US 7,377,941 B2
• Filed: 05/06/2005
• Issued: 05/27/2008
• 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, Rhee, Richard S.
• Primary Examiner(s): SWEET, THOMAS
• Application Number:
  US11/124,405
• Publication Number:
  US 20050288780A1
• Time in Patent Office: 1,117 Days
• Field of Search: 623/2.36, 623/2.37
• 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 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. 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 without substantially decreasing a distance between the two lateral portions.

Claims

1. An annuloplasty device, configured to support a heart valve having an annulus that defines a perimeter around the 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 distance between said anterior portion and said posterior portion without substantially decreasing a distance between said two lateral portions; and

a flexible member coupled to the body;

wherein the flexible member is configured such that, when the annuloplasty device is secured to the heart, the flexible member is anchorable to heart tissue at or adjacent to the annulus, along at least a portion of the perimeter, the portion of the perimeter extending between fibrous trigones of the heart.

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

3. The annuloplasty device of claim 2, wherein said one or more imaging markers comprise radiopaque markers.

4. The annuloplasty device of claim 1, wherein said transformation is further configured to increase said distance between said two lateral portions.

5. 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.

6. The annuloplasty device of claim 5, 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.

7. The annuloplasty device of claim 5, wherein said first shape memory member comprises a tubular structure, and wherein at least a portion of said wire passes through said tubular structure.

8. The annuloplasty device of claim 7, 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.

9. The annuloplasty device of claim 7, 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.

10. The annuloplasty device of claim 9, wherein said annuloplasty device in said third shape has a reduced distance between said anterior portion and said posterior portion as compared to said second shape.

11. The annuloplasty device of claim 9, wherein said annuloplasty device in said third shape has an increased distance between said anterior portion and said posterior portion as compared to said second shape.

12. The annuloplasty device of claim 9, wherein at least one of said first activation energy and said second activation energy comprises a magnetic field.

13. The annuloplasty device of claim 9, wherein at least one of said first activation energy and said second activation energy comprises acoustic energy.

14. The annuloplasty device of claim 9, wherein at least one of said first activation energy and said second activation energy comprises radio frequency energy.

15. The annuloplasty device of claim 9, 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.

16. The annuloplasty device of claim 15, wherein said first activation temperature is lower than said second activation temperature.

17. The annuloplasty device of claim 15, wherein said first activation temperature is lower than said second activation temperature.

18. The annuloplasty device of claim 1, wherein said first activation energy comprises a magnetic field.

19. The annuloplasty device of claim 1, wherein said first activation energy comprises acoustic energy.

20. The annuloplasty device of claim 1, wherein said first activation energy comprises radio frequency energy.

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

22. The annuloplasty device of claim 21, 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.

23. The annuloplasty device of claim 22, 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.

24. The annuloplasty device of claim 23, further comprising a second shape memory band at least partially disposed between or adjacent to said overlapping portions of said first shape memory band.

25. The annuloplasty device of claim 24, 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.

26. The annuloplasty device of claim 25, wherein said annuloplasty device in said third configuration has a reduced distance between said anterior portion and said posterior portion as compared to said second shape.

27. The annuloplasty device of claim 25, wherein said annuloplasty device in said third configuration has an increased distance between said anterior portion and said posterior portion as compared to said second shape.

28. The annuloplasty device of claim 25, wherein at least one of said first activation energy and said second activation energy comprises a magnetic field.

29. The annuloplasty device of claim 25, wherein at least one of said first activation energy and said second activation energy comprises acoustic energy.

30. The annuloplasty device of claim 25, wherein at least one of said first activation energy and said second activation energy comprises radio frequency energy.

31. The annuloplasty device of claim 25, 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.

32. The annuloplasty device of claim 31, wherein said first activation temperature is lower than said second activation temperature.

33. An annuloplasty device configured to be secured to a heart, at or near a base of a heart valve having an annulus that defines a perimeter around the valve, the annuloplasty device comprising:

a body, comprising;

an elongate members 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 distance between said anterior portion and said posterior portion without substantially reducing a distance between said two lateral portions; and

a flexible member coupled to the body;

wherein the flexible member is configured to be anchored to a heart tissue, at or adjacent to the annulus along at least a portion of the perimeter, the portion of the perimeter extending between fibrous trigones of the heart; and

wherein, when the device is secured to the heart, and when the flexible member is anchored to the heart tissue, and the first shape memory member responds to the first activation energy, a distance between an anterior aspect and posterior aspect of the valve is reduced.

34. The annuloplasty device of claim 33, 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.

35. The annuloplasty device of claim 33, 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.

36. The annuloplasty device of claim 35, 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.

37. The annuloplasty device of claim 35, 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.

38. The annuloplasty device of claim 37, wherein said elongate member in said third shape has a reduced distance between said anterior portion and said posterior portion as compared to said second shape.

39. The annuloplasty device of claim 37, wherein said elongate member in said third shape has an increased distance between said anterior portion and said posterior portion as compared to said second shape.

40. The annuloplasty device of claim 37, wherein at least one of said first activation energy and said second activation energy comprises a magnetic field.

41. The annuloplasty device of claim 37, wherein at least one of said first activation energy and said second activation energy comprises acoustic energy.

42. The annuloplasty device of claim 37, wherein at least one of said first activation energy and said second activation energy comprises radio frequency energy.

43. The annuloplasty device of claim 37, 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.

44. The annuloplasty device of claim 33, wherein said first activation energy comprises a magnetic field.

45. The annuloplasty device of claim 33, wherein said first activation energy comprises acoustic energy.

46. The annuloplasty device of claim 33, wherein said first activation energy comprises radio frequency energy.

47. An annuloplasty device comprising:

adjustment means for changing a patient'"'"'s cardiac valve annulus size in an anteroposterior dimension without substantially changing said annulus in a 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; and

anchoring means coupled to said adjustment means, said anchoring means configured to anchor the device to heart tissue (1) at or adjacent to the annulus, and (2) along at least a portion of a perimeter around the valve defined by the annulus, the at least a portion of the perimeter extending between fibrous trigones of the heart.

48. An annuloplasty device that changes a patient'"'"'s cardiac valve annulus size in an anteroposterior dimension without substantially 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, comprising:

an arcuate body;

a flexible member, coupled to the arcuate body;

wherein the flexible member is configured to anchor the device to heart tissue (1) at or adjacent to the annulus, and (2) along at least a portion of a perimeter around the valve defined by the annulus, the at least a portion of the perimeter extending between fibrous trigones of the heart;

wherein, when the device is secured to the heart, and when the flexible member is anchored to the heart tissue, and when the device responds to the energy transmission, the cardiac valve annulus size changes in the anteroposterior dimension.

49. An annuloplasty device, configured to support a heart valve having an annulus that defines a closed perimeter, the device comprising:

an arcuate body that has a first shape in a first configuration and a second shape in a second configuration;

wherein the arcuate body is configured to transform from the first configuration to the second configuration in response to an activation energy applied thereto;

wherein the transformation reduces a distance between an anterior portion of the arcuate body and a posterior portion of the arcuate body without substantially decreasing a distance between two lateral portions of the arcuate body; and

a flexible member coupled to the arcuate body;

wherein the flexible member is configured to be anchored to heart tissue at or adjacent to the annulus, along at least a portion of the perimeter, the portion of the perimeter extending between fibrous trigones of the heart; and

wherein, when the device is secured to the heart, and when the flexible member is anchored to the heart tissue, and when the device responds to the activation energy, the cardiac valve annulus size changes in the anteroposterior dimension.