CARDIAC VALVE IMPLANT WITH ENERGY ABSORBING MATERIAL

• US 20080215145A1
• Filed: 02/15/2008
• Published: 09/04/2008
• Est. Priority Date: 06/29/2004
• Status: Active Grant

• Current Assignee: MiCardia Corporation
• Original Assignee: MiCardia Corporation
• Inventors: Shaolian, Samuel M., Moaddeb, Shahram, Shaoulian, Emanuel
• Granted Patent: US 7,722,668 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 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;

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;

a first segment, having a first end and a second end, and a second segment, having a first end and a second end,

wherein said first segment and said second segment have original lengths when said annuloplasty ring is in said first configuration,

wherein said second end of said first segment is proximate said first end of said second segment, and said first segment and said second segment are oriented end-to-end with respect to each other,

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

wherein, when said annuloplasty ring is in said second configuration, said first segment remains at substantially its original length, and said second segment has a length that is less than its original length; and

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

2. The device of claim 1, wherein said energy transfer material is further configured to heat in response to said first activation energy.

3. The device of claim 2, wherein said transfer material is configured to transfer heat to said shape memory material.

4. The 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.

5. The 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.

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

7. The device of claim 1, wherein said energy transfer material is radiopaque.

8. The device of claim 1, wherein said energy comprises at least one of radio frequency energy, x-ray energy, microwave energy, acoustic energy ultrasound, light energy, electrical energy, magnetic field energy, thermal energy, and combinations thereof.

9. The device of claim 8, wherein the acoustic energy comprises high intensity focused ultrasound.

10. The device of claim 1, wherein the body further comprises markers configured to be detectable by at least one of magnetic resonance imaging, computed tomography imaging, ultrasound imaging, and combinations thereof.

11. The device of claim 1, wherein the first activation energy results in at least a portion of the body member having a first temperature in a range from about 38°

C. to about 75°

C.

12. The device of claim 11, wherein the first temperature is in a range from about 38°

C. to about 60°

C.

13. The device of claim 11, wherein the first temperature is in a range from about 40°

C. to about 59°

C.

14. The device of claim 11, wherein the first temperature is in a range from about 40°

C. to about 55°

C.

15. The device of claim 1, wherein the shape memory material comprises a first shape memory portion and a second shape memory portion.

16. The device of claim 15, wherein the first shape memory portion is configured to contract in response to an activation energy.

17. The device of claim 15, wherein the second shape memory portion is configured to expand in response to an activation energy.

18. The device of claim 15, wherein the first shape memory portion has an austentite start temperature in a range from about 33°

C. to about 43°

, and an austentite finishing temperature in a range from about 45°

C. to about 55°

C.

19. The device of claim 18, wherein the austentite finishing temperature is in a range from about 48.75°

C. to about 51.25°

C.

20. The device of claim 15, wherein the first shape memory portion has a martensite start temperature less than about 30°

C., and a martensite finishing temperature greater than about 20°

C.

21. The device of claim 15, wherein the second shape memory portion has an austentite start temperature in a range from about 60°

C. to about 70°

, and an austentite finishing temperature in a range from about 65°

C. to about 75°

C.

22. The device of claim 21, wherein the austentite finishing temperature is in a range from about 68.75°

C. to about 71.25°

C.

23. The device of claim 15, wherein the second shape memory portion has a martensite start temperature less than about 30°

C., and a martensite finishing temperature greater than about 20°

C.

24. The device of claim 1, wherein the body member is configured to change from the first configuration to the second configuration by increments.

25. The device of claim 1, further comprising a ratchet mechanism located on a proximal portion of the body member configured to engage a distal portion of the body member

26. The device of claim 25, wherein the ratchet is configured to prevent expansion of the device when the distal portion is engaged.

27. The device of claim 25, wherein the distal portion of the body member comprises a plurality of detents configured to permit incremental advancement of the distal portion.

28. The device of claim 1, wherein the body dimension in the first configuration differs from the body dimension in the second configuration by an amount in range from about 6% to about 23%.

29. The device of claim 1, wherein the device is configured to be substantially non-circular.