Methods for treating cardiac valves with adjustable implants

• US 20050288779A1
• Filed: 05/06/2005
• Published: 12/29/2005
• Est. Priority Date: 06/29/2004
• Status: Active Grant

• Current Assignee: MiCardia Corporation
• Original Assignee: MiCardia Corporation
• Inventors: Moaddeb, Shahram, Shaoulian, Emanuel, Shaolian, Samuel
• Granted Patent: US 7,713,298 B2
• 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 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 shape memory material that is responsive to changes in temperature and/or exposure to a magnetic field. A material having enhanced absorption characteristics with regard to a desired heating energy may be used in order to facilitate heating and adjustment of the support device.

Claims

1. A method for treating a patient'"'"'s cardiac valve, said method comprising:

providing an annuloplasty ring having a first size of a dimension of said ring in a first configuration and a second size of said dimension of said ring in a second configuration;

attaching said annuloplasty ring while in said first configuration to or near a valve annulus in a heart having a first end-diastolic volume of a ventricle; and

after said ventricle has a second end-diastolic volume, said second end-diastolic volume being less than said first end-diastolic volume, changing said annuloplasty ring from said first configuration to said second configuration, wherein said second size is less than said first size.

2. The method of claim 1, wherein changing said annuloplasty ring from said first configuration to said second configuration comprises applying energy to a shape memory material of said annuloplasty ring.

3. The method of claim 2, wherein applying said energy to said annuloplasty ring comprises heating a shape memory material of said annuloplasty ring to a predetermined temperature, wherein said shape memory material changes shape in response to being heated to said predetermined temperature.

4. The method of claim 3, wherein said heating of said shape memory material comprises applying said energy to an energy absorption enhancement material in thermal communication with said shape memory material.

5. The method of claim 3, wherein said heating of said shape memory material comprises applying said energy to an electrically conductive material in thermal communication with said shape memory material, wherein said energy produces a current in said electrically conductive material.

6. The method of claim 2, wherein applying said energy comprises non-invasively applying said energy from outside the patient'"'"'s body to said annuloplasty ring located inside said patient'"'"'s body.

7. The method of claim 6, wherein applying said energy to said annuloplasty ring comprises generating a magnetic field outside said patient'"'"'s body, wherein said magnetic field is configured to change the shape of a shape memory material of said annuloplasty ring.

8. The method of claim 7, wherein said shape memory material comprises a ferromagnetic material.

9. The method of claim 6, wherein non-invasively applying said energy comprises generating magnetic field energy,

10. The method of claim 6, wherein non-invasively applying said energy comprises generating electromagnetic energy.

11. The method of claim 6, wherein non-invasively applying said energy comprises generating mechanical energy.

12. The method of claim 6, wherein non-invasively applying said energy comprises generating acoustic energy.

13. The method of claim 12, wherein said acoustic energy is focused ultrasound energy.

14. The method of claim 13, wherein said focused ultrasound energy is not destructive to the patient'"'"'s cardiac tissue.

15. The method of claim 9, wherein said acoustic energy comprises high-intensity focused ultrasound energy.

16. The method of claim 15, further comprising generating said high-intensity focused ultrasound energy with a handheld device.

17. The method of claim 9, further comprising generating said electromagnetic energy using a handheld device.

18. The method of claim 9, further comprising generating said magnetic field using a magnetic resonance imaging device.

19. The method of claim 18, further comprising imaging said annuloplasty ring with said magnetic resonance imaging device.

20. The method of claim 2, wherein applying said energy comprises percutaneously applying said energy to said annuloplasty ring located inside said patient'"'"'s body.

21. The method of claim 20, wherein percutaneously applying said energy comprises applying at least one of radio frequency energy, light energy, acoustic energy, and thermal energy.

22. The method of claim 21, wherein applying said thermal energy comprises applying said thermal energy with a balloon catheter assembly.

23. The method of claim 22, further comprising heating a thermal conductor with said balloon catheter assembly, wherein said thermal conductor is in thermal communication with said shape memory material.

24. The method of claim 21, further comprising illuminating a photodynamic absorbing material with said light energy.

25. The method of claim 24, wherein illuminating said photodynamic absorbing material results in a release of one or more drugs.

26. The method of claim 2, further comprising non-invasively monitoring the sizes of said annuloplasty ring before and after said ring changes from said first configuration to said second configuration.

27. The method of claim 26, wherein non-invasively monitoring the sizes of said annuloplasty ring comprises operating a monitoring device comprising at least one of a magnetic resonance imaging device, an ultrasound imaging device, a computed tomography device, and an X-ray device.

28. The method of claim 1, further comprising changing said annuloplasty ring from said second size to a third size of said dimension in a third configuration.

29. The method of claim 28, wherein said third size is less than said second size.

30. The method of claim 29, wherein said third size is larger than said second size.

31. The method of claim 1, wherein the dimension is a septolateral dimension of the annuloplasty ring.

32. A method for treating a patient'"'"'s cardiac valve, said method comprising:

providing an annuloplasty ring having a first size of a dimension of said ring in a first configuration and a second size of said dimension of said ring in a second configuration;

in an operation, attaching said annuloplasty ring while in said first configuration to or near a valve annulus in a heart; and

changing said annuloplasty ring from said first configuration to said second configuration, wherein said second size is less than said first size.

33. The method of claim 32, wherein said changing occurs while the patient'"'"'s heart is surgically closed.

34. A method for treating a patient'"'"'s cardiac valve, said method comprising:

providing an annuloplasty ring having a first size of a dimension of said ring in a first configuration and a second size of said dimension of said ring in a second configuration;

while the patient'"'"'s heart is surgically open, attaching said annuloplasty ring while in said first configuration to or near a valve annulus in a heart; and

changing said annuloplasty ring from said first configuration to said second configuration, wherein said second size is less than said first size.

35. The method of claim 34, wherein said changing occurs while the patient'"'"'s heart is surgically closed.

36. A method for treating a patient'"'"'s cardiac valve, said method comprising:

providing an annuloplasty ring having a first size of a dimension of said ring in a first configuration and a second size of said dimension of said ring in a second configuration;

in said first configuration, attaching said annuloplasty ring to or near a valve annulus in a heart; and

applying acoustic energy from a focused ultrasound device to a focal zone at or near said annuloplasty ring, wherein said annuloplasty ring responds to said acoustic energy by transforming from said first configuration to said second configuration.

37. The method of claim 36, wherein said acoustic energy is non-destructive to the patient'"'"'s cardiac tissue.

38. The method of claim 36, further comprising acquiring an image of said annuloplasty ring using said focused ultrasound device.

39. The method of claim 36, wherein said second size is less than said first size.

40. The method of claim 39, further comprising. transforming said annuloplasty ring to a third size of said dimension of said ring in a third configuration.

41. The method of claim 40, wherein said third size is greater than said second size.

42. The method of claim 40, wherein said third size is less than said second size.

43. The method of claim 40, further comprising using said focused ultrasound device to transform said annuloplasty ring to said third size.