Adjustable prosthetic valve implant

• US 20070142907A1
• Filed: 12/14/2006
• Published: 06/21/2007
• Est. Priority Date: 12/16/2005
• Status: Abandoned Application

• Current Assignee: MiCardia Corporation
• Original Assignee: MiCardia Corporation
• Inventors: Lenker, Jay, Shaoulian, Emanuel, Shaolian, Samuel, Moaddeb, Shawn
• Application Number:
  US11/638,473
• Publication Number:
  US 20070142907A1
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

A prosthetic implant for treating a diseased aortic valve is described. The prosthetic implant includes a substantially tubular body configured to be positioned in an aorta of a patient, at or near the patient'"'"'s aortic valve. The body includes a lumen extending through the body from a proximal end to a distal end of the body; and an adjustable frame surrounding the lumen. The prosthetic implant further includes at least one adjustable element located in or on the body and extending at least partially around a circumference of the lumen. The at least one adjustable element includes a shape memory material and is transformable, in response to application of an activation energy, from a first configuration to a second configuration, wherein the first configuration and second configuration differ in a size of at least one dimension of the at least one adjustable element. The at least one adjustable element may engage at least one of a root of the aorta, an annulus of the aortic valve, and the patient'"'"'s left ventricle, when the at least one adjustable element is in the second configuration.

Claims

1. A prosthetic implant, for treating a diseased aortic valve, comprising:

a substantially tubular body configured to be positioned in an aorta of a patient, at or near the patient'"'"'s aortic valve, the body comprising;

a lumen extending through the body from a proximal end to a distal end of the body; and

an adjustable frame surrounding the lumen; and

at least one adjustable element located in or on the body and extending at least partially around a circumference of the lumen;

wherein the at least one adjustable element comprises a shape memory material and is transformable, in response to application of an activation energy, from a first configuration to a second configuration, wherein the first configuration and second configuration differ in a size of at least one dimension of the at least one adjustable element; and

wherein the at least one adjustable element is configured to engage at least one of a root of the aorta, an annulus of the aortic valve, and the patient'"'"'s left ventricle, when the at least one adjustable element is in the second configuration.

2. The prosthetic implant of claim 1, wherein the at least one adjustable element is coupled to at least one prosthetic aortic valve leaflet.

3. The prosthetic implant of claim 1, wherein the at least one adjustable element comprises a prosthetic aortic valve annulus.

4. The prosthetic implant of claim 1, wherein the shape memory material is selected from the group consisting of shape memory metals, shape memory alloys, shape memory polymers, shape memory ferromagnetic alloys, and combinations thereof.

5. The prosthetic implant of claim 4, wherein the shape memory material comprises nitinol.

6. The prosthetic implant of claim 1, wherein the at least one dimension of the second configuration is greater than the at least one dimension of the first configuration.

7. The prosthetic implant of claim 1, wherein the at least one dimension of the second configuration is less than the at least one dimension of the first configuration.

8. The prosthetic implant of claim 6, wherein the at least one dimension is a diameter.

9. The prosthetic implant of claim 6, wherein the at least one dimension is a length.

10. The prosthetic implant of claim 1, wherein the at least one adjustable element is disposed in proximity to the open end of at least one of the distal end and the proximal end.

11. The prosthetic implant of claim 10, wherein a graft member covers at least a portion of at least one of the at least one adjustable element and the body.

12. The prosthetic implant of claim 10, further comprising at least a second adjustable element disposed between the distal end and the proximal end.

13. The prosthetic implant of claim 1, wherein the frame comprises the at least one adjustable element.

14. The prosthetic implant of claim 1, wherein the frame is expandable.

15. The prosthetic implant of claim 1, wherein the adjustable element comprises a closed ring.

16. The prosthetic implant of claim 15, wherein the closed ring comprises a one-way ratchet.

17. The prosthetic implant of claim 1, wherein the adjustable element comprises an open ring.

18. The prosthetic implant of claim 17, wherein the adjustable element comprises a spiral portion.

19. The prosthetic implant of claim 1, wherein an insulating layer is disposed on at least a portion of the shape memory material.

20. The prosthetic implant of claim 19, wherein portions of the shape memory material are exposed through openings in the insulating layer.

21. The prosthetic implant of claim 1, wherein an energy-absorbing material is disposed on at least a portion of the shape memory material.

22. The prosthetic implant of claim 21, wherein the energy absorbing material absorbs ultrasonic energy.

23. The prosthetic implant of claim 21, wherein the energy absorbing material absorbs radio frequency energy.

24. The prosthetic implant of claim 1, wherein the adjustable element comprises wherein a wire loop that at least partially surrounds around a portion of the shape memory material.

25. The prosthetic implant of claim 1, wherein a check valve is affixed to a central region of the body.

26. The prosthetic implant of claim 25, wherein the check valve is a tri-leaflet check valve.

27. The prosthetic implant of claim 1, further comprising an activation post configured to transmit activation energy to the at least one adjustable element.

28. The prosthetic implant of claim 1, further comprising a crown support.

29. A prosthetic implant for treating a diseased valve in a patient'"'"'s aorta, the prosthetic implant comprising:

valve means for permitting one-way flow of blood from the patient'"'"'s left ventricle into the aorta;

engagement means for engaging at least one of a root of the aorta, an annulus of the aortic valve, and the patient'"'"'s left ventricle, the engagement means being coupled to the valve means;

support means for supporting the valve means and coupled to the valve means, the support means being configured to extend distally into the ascending aorta beyond the aortic valve annulus when the valve means is in position at the aortic valve;

wherein the engagement means is adjustable from a first configuration to a second configuration in response to an activation energy established using an energy source external to the patient'"'"'s body, wherein the first configuration and second configuration differ in size in at least one dimension; and

wherein the engagement means engages the at least one of the root of the aorta, the annulus of the aortic valve, and the patient'"'"'s left ventricle, when in the second configuration.

30. A method, for treating an abdominal aortic aneurysm, comprising:

providing a prosthetic implant, comprising;

a substantially tubular body configured to be positioned in an aorta of a patient, at or near the patient'"'"'s aortic valve, the body comprising;

a lumen extending through the body from a proximal end to a distal end of the body; and

an adjustable frame surrounding the lumen; and

at least one adjustable element located in or on the body and extending at least partially around a circumference of the lumen;

wherein the at least one adjustable element comprises a shape memory material and is transformable, in response to application of an activation energy, from a first configuration to a second configuration, wherein the first configuration and second configuration differ in a size of at least one dimension of the at least one adjustable element; and

wherein the at least one adjustable element is configured to engage at least one of a root of the aorta, an annulus of the aortic valve, and the patient'"'"'s left ventricle, when the at least one adjustable element is in the second configuration; and

exposing the device to the activation energy, changing the at least one adjustable element from the first configuration to the second configuration.

31. The method of claim 30, further comprising implanting the prosthetic implant at the aortic valve region percutaneously.

32. The method of claim 31, wherein the implanting comprises expanding at least a portion of the prosthetic implant using a balloon.

33. The method of claim 30, wherein the device is exposed to the activation energy post-implantation.

34. The method of claim 31, wherein the device is exposed to an activation energy in multiple procedures.

35. The method of claim 30, wherein the activation energy comprises radio frequency energy.

36. The method of claim 30, wherein the activation energy comprises ultrasound energy.

37. The method of claim 30, wherein the activation energy comprises magnetic energy.

38. The method of claim 30, wherein the at least one adjustable element is imaged contemporaneously with exposure to the activation energy.

39. A catheter device for activating an adjustable implant, the catheter device comprising:

an elongate body having a proximal end and a distal end, the body configured to be placed within a patient'"'"'s heart and/or aorta;

a first slot member, having a first slot, the first slot member disposed at the distal end of the body;

an energy-transfer member configured to couple to an activation post on a valve implant when the implant is located in the heart and the activation post is positioned at least partially within the slot member;

at least one activation lead configured to provide a transfer of energy between an energy source located outside of the patient and the energy-transfer member.

40. The adjustment catheter of claim 39, wherein the energy-transfer member is configured to thermally couple to the activation post.

41. The adjustment catheter of claim 39, wherein the energy source is coupled to the proximal end of the catheter system.

42. The adjustment catheter of claim 39, wherein the first slot member further comprises a sharp edge configured to cut through tissue on the activation post.

43. The adjustment catheter of claim 39, further comprising a second slot member, having a second slot, wherein the second slot is disposed at or near the distal end of the body.

44. The adjustment catheter of claim 39, further comprising a locking member for securely coupling the activation post with the body.

45. The adjustment catheter of claim 39, further comprising a spring-loaded tab within the slot or opening.

46. The adjustment catheter of claim 39, further comprising radiopaque markers.