Adjustable prosthetic valve implant

• US 8,449,604 B2
• Filed: 08/19/2009
• Issued: 05/28/2013
• Est. Priority Date: 12/16/2005
• Status: Expired due to Fees

• Current Assignee: MiCardia Corporation
• Original Assignee: MiCardia Corporation
• Inventors: Moaddeb, Shawn, Shaolian, Samuel, Shaoulian, Emanuel, Lenker, Jay A.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US12/544,163
• Publication Number:
  US 20100185274A1
• Time in Patent Office: 1,378 Days
• Field of Search: 623 214- 219, 623/1.24, 623/1.26
• US Class Current: 623/2.1
• 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 ring and an electrically conductive wire wrapped around the ring, the wire being configured to conduct heat to the ring, so that the at least one adjustable element 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 6, wherein the at least one dimension is a diameter.

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

9. 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.

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 a check valve is affixed to a central region of the body.

25. The prosthetic implant of claim 24, wherein the check valve is a tri-leaflet check valve.

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

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

28. 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 a wire is wrapped around the engagement means, the wire being configured to conduct heat to the engagement means, so that 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.