Medical device for treating a heart valve insufficiency

• US 7,914,575 B2
• Filed: 10/02/2009
• Issued: 03/29/2011
• Est. Priority Date: 04/13/2007
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Guyenot, Volker, Damm, Christoph, Jung, Johannes, Peschel, Thomas, Ferrari, Markus, Figulla, Hans-Reiner
• Primary Examiner(s): McDermott; Corrine M
• Assistant Examiner(s): Schall; Matthew
• Application Number:
  US12/572,340
• Publication Number:
  US 20100049303A1
• Time in Patent Office: 543 Days
• Field of Search: 623/2.41, 623/2.42, 623/1.2, 623/2.1, 623 212- 219, 623/1.26, 623/1.24, 623/1.3, 623/1.31
• US Class Current: 623/2.14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: Y10T 29/5116 forging and bending, cutting or punching

Abstract

A medical device for treating a heart valve insufficiency, with an endoprosthesis which can be introduced into a patient'"'"'s body and expanded to secure a heart valve prosthesis in the patient'"'"'s aorta. In an embodiment, the endoprosthesis has at plurality of positioning arches configured to be positioned with respect to a patient'"'"'s aorta and a plurality of retaining arches to support a heart valve prosthesis. The endoprosthesis includes a first collapsed mode during the process of introducing it into the patient'"'"'s body and a second expanded mode when it is implanted.

Claims

1. A method of treating an insufficiency of a native valve with a valve prosthesis supported on a stent including a plurality of first arches, each having an apex oriented in a first direction and an open end that is joined to an open end of an adjacent first arch, and a plurality of second arches, each having an apex oriented in the first direction and an open end that is joined to an open end of an adjacent second arch, wherein the valve prosthesis is directly attached to the plurality of second arches, the method comprising:

positioning the plurality of first arches within pockets of the native valve, such that the respective apices of the plurality of first arches project toward the pockets of the native valve, and open ends of the plurality of first arches project away from the pockets of the native valve;

clamping at least a portion of the native valve between the plurality of first arches and the plurality of second arches; and

engaging at least a portion of the native valve with a vessel wall.

2. The method of claim 1, wherein the stent is configured to expand from a collapsed mode to an expanded mode.

3. The method of claim 2, wherein the plurality of first arches is configured to expand independently of the plurality of second arches.

4. The method of claim 3, wherein the step of positioning the plurality of first arches is performed before the plurality of second arches is expanded.

5. The method of claim 1, wherein the stent is made from a self-expandable shape memory alloy, the method further including expanding the stent from a collapsed mode to an expanded mode by heating the stent above a transition temperature, retaining the heated stent via a catheter, and subsequently releasing the stent to allow the stent to self-expand.

6. The method of claim 1, wherein the valve prosthesis is a naturally occurring valve.

7. The method of claim 1, wherein each of the plurality of first arches and each of the plurality of second arches includes a substantially U-shaped or V-shaped structure.

8. The method of claim 1, wherein the native valve is an aortic valve.

9. The method of claim 1, wherein:

the open ends of the plurality of first arches are oriented toward a distal end of the stent, and the apices of the plurality of first arches are oriented toward a proximal end of the stent;

the stent includes a first, collapsed mode during implantation and a second, expanded mode when implanted; and

the distal end of the stent includes a diameter that is approximately 10% to 25% bigger than a diameter of the proximal end of the stent when the stent is in the second, expanded mode.

10. The method of claim 1, wherein the plurality of first arches includes only three first arches.

11. The method of claim 1, wherein each apex of each of the plurality of first arches is cantilevered relative to a distal end of the stent.

12. The method of claim 1, wherein each of the plurality of first arches is circumferentially aligned and axially nested relative to a respective one of the plurality of second arches.

13. The method of claim 1, wherein the valve prosthesis is sutured directly to the plurality of second arches.

14. The method of claim 1, wherein the stent further includes a plurality of connecting webs, each connecting web disposed axially between and connecting an open end of a first arch and an open end of a second arch.

15. The method of claim 1, wherein the plurality of first arches are equally spaced about the circumference of the stent and circumscribe a distal end of the stent.

16. The method of claim 1, further including positioning at least a portion of each of the three leaflets of the native valve within an interior of the stent.

17. A method of treating an insufficiency of a native valve having a plurality of valve leaflets with a valve prosthesis supported on a stent including (i) a plurality of first elements each including first and second arms connected at respective proximal ends thereof to one another, forming a first plurality of closed ends, and connected at respective distal ends thereof to a respective first or second arm of an adjacent first element, forming a first plurality of open ends, and (ii) a plurality of second elements each including third and fourth arms connected at respective proximal ends thereof to one another, forming a second plurality of closed ends, and connected at respective distal ends thereof to a respective third or fourth arm of an adjacent second element, forming a second plurality of open ends, wherein the valve prosthesis is attached to the stent via the second elements, the method comprising:

positioning each of the closed ends of the plurality of first elements within a respective pocket of the native valve such that the closed ends of the plurality of first elements project towards a respective pocket and the open ends of the plurality of first elements project away from the respective pocket;

clamping each of the plurality of valve leaflets between the plurality of first elements and the plurality of second elements; and

engaging at least a portion of the native valve leaflets with a vessel wall.

18. The method of claim 17, wherein the stent includes a collapsed mode during implantation and a expanded mode when implanted, the method further including radially compressing each of the plurality of valve leaflets against a vessel wall when the stent is in the expanded mode.

19. The method of claim 18, further including positioning the plurality of second elements radially inward of the plurality of leaflets and positioning the plurality of first elements radially outward of the plurality of leaflets.

20. The method of claim 17, wherein the native valve is an aortic valve.

21. The method of claim 17, wherein positioning each of the closed ends of the plurality of first elements within a respective pocket of the native valve includes:

expanding the plurality of first elements from a collapsed mode to an expanded mode while maintaining the plurality of second elements in a collapsed mode;

positioning a closed end of each of the plurality of first elements within a respective pocket of the native valve before positioning a remainder of each of the plurality of first elements relative the respective pocket of the native valve; and

subsequently expanding the plurality of second elements from the collapsed mode to an expanded mode.

22. The method of claim 17, further including expanding the plurality of second elements and the valve prosthesis at substantially the same time.

23. The method of claim 17, wherein the plurality of first elements includes only three first elements.

24. The method of claim 17, wherein each of the plurality of first elements and each of the plurality of second elements includes a substantially U-shaped or substantially V-shaped structure.

25. The method of claim 17, wherein the closed end of each of the plurality of first elements is cantilevered relative to a distal end of the stent.

26. The method of claim 17, wherein each of the plurality of first elements is circumferentially aligned and axially nested relative to a respective one of the plurality of second elements.

27. The method of claim 17, wherein the valve prosthesis is sutured directly to the plurality of second elements.

28. The method of claim 17, wherein the stent further includes a plurality of connecting webs, each connecting web disposed axially between and connecting an open end of a first element and an open end of a second element.

29. The method of claim 17, wherein the plurality of first elements are equally spaced about the circumference of the stent and circumscribe a distal end of the stent.

30. The method of claim 17, further including positioning at least a portion of each of the three leaflets of the native valve within an interior of the stent.

31. A method of treating an insufficiency of a native aortic valve having three valve leaflets defining three valve pockets, with a valve prosthesis supported on a stent including (i) three first arches defining three first closed ends adjacent a proximal end of the stent, wherein the three first arches are equally spaced about the circumference of the stent and circumscribe the stent, and (ii) three second arches defining three second closed ends adjacent the proximal end of the stent, each of the three second arches being substantially circumferentially aligned with one of the three first arches, wherein the valve prosthesis is directly attached to the three second arches, the method comprising:

positioning each of the closed ends of the three first arches within a respective one of the three valve pockets such that each of the closed ends of the three first arches engages the respective one of the three valve pockets; and

clamping each of the three valve leaflets between a respective one of the three first arches and a respective one of the three second arches;

such that each of the three valve leaflets is disposed radially inward of the three first arches and radially outward the three second arches.

32. The method of claim 31, wherein the stent includes a collapsed mode during implantation and an expanded mode when implanted, the method further including radially compressing each of the three valve leaflets against a vessel wall when the stent is in the expanded mode.

33. The method of claim 31, wherein, each of the three first arches and each of the three second arches includes a substantially U-shaped or substantially V-shaped structure.

34. The method of claim 31, wherein each apex of each of the three first arches is cantilevered relative to a distal end of the stent.

35. The method of claim 31, wherein each of the three first arches is circumferentially aligned and axially nested relative to a respective one of the three second arches.

36. The method of claim 31, wherein the valve prosthesis is sutured directly to the plurality of second arches.

37. The method of claim 31, wherein the stent further includes three connecting webs, each connecting web disposed axially between and connecting an open end of a first arch and an open end of a second arch.

38. The method of claim 31, further including positioning at least a portion of each of the three leaflets of the native valve within an interior of the stent.

39. The method of claim 31, further including engaging at least a portion of the native valve leaflets with a vessel wall.