Medical device for treating a heart valve insufficiency

• US 8,685,085 B2
• Filed: 02/18/2011
• Issued: 04/01/2014
• Est. Priority Date: 04/13/2007
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology GmbH (JenaValve Technology, Inc.)
• Inventors: Guyenot, Volker, Peschel, Thomas, Damm, Christoph, Figulla, Hans-Reiner, Ferrari, Markus, Jung, Johannes
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US13/030,708
• Publication Number:
  US 20110238159A1
• Time in Patent Office: 1,138 Days
• Field of Search: 623/2.1, 623 212- 219
• 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 implanting an endoprosthesis having a plurality of positioning arches, a plurality of retaining arches, and a prosthetic valve attached to the plurality of retaining arches such that at least a part of the prosthetic valve extends from the plurality of retaining arches transversely across an interior of the endoprosthesis, the method comprising:

positioning the endoprosthesis adjacent a native valve;

expanding the plurality of positioning arches from a collapsed configuration to an expanded configuration while holding the plurality of retaining arches in a collapsed configuration;

positioning the expanded plurality of positioning arches radially outward of at least one native leaflet of the native valve and radially inward of a vessel wall;

expanding the plurality of retaining arches from the collapsed configuration to an expanded configuration; and

engaging the at least one native leaflet of the native valve with at least one of the plurality of positioning arches and at least one of the plurality of retaining arches.

2. The method of claim 1, further including maneuvering the endoprosthesis through a patient'"'"'s vasculature toward the patient'"'"'s heart to position the endoprosthesis adjacent the native valve.

3. The method of claim 2, further including maneuvering the endoprosthesis through a femoral artery and an aortic artery to position the endoprosthesis adjacent the native valve.

4. The method of claim 1, further including maneuvering the endoprosthesis through a wall of the patient'"'"'s heart to position the endoprosthesis adjacent the native valve.

5. The method of claim 1, further including clamping the at least one native valve leaflet with at least one positioning arch and at least one retaining arch.

6. The method of claim 1, further including pressing the at least one native valve leaflet against the vessel wall.

7. The method of claim 1, wherein expanding the plurality of positioning arches includes releasing the plurality of positioning arches from a catheter.

8. The method of claim 7, wherein the plurality of positioning arches self-expand.

9. The method of claim 1, wherein expanding the plurality of retaining arches includes releasing the plurality of retaining arches from a catheter.

10. The method of claim 9, wherein the plurality of retaining arches self-expand.

11. The method of claim 1, wherein each positioning arch is associated with a corresponding retaining arch and has a distal end portion axially aligned, along a longitudinal direction of the endoprosthesis, with and joined to a distal end portion of the corresponding retaining arch.

12. The method of claim 1, wherein radially outer most portions of the endoprosthesis are defined by the plurality of positioning arches and the plurality of retaining arches.

13. The method of claim 1, wherein an apex of each of the plurality of positioning arches is substantially axially aligned along a longitudinal direction of the endoprosthesis with an apex of a corresponding retaining arch.

14. The method of claim 1, wherein each positioning arch includes a pair of arms connected to one another forming a distal open end and a closed proximal end, each arm connected at a distal end thereof to a respective connecting web, such that each positioning arch defines a single apex between two adjacent connecting webs, and wherein each retaining arch includes a pair of arms connected to one another forming a distal open end and a proximal closed end, each arm connected at a distal end thereof to a respective connecting web, such that each retaining arch defines a single apex between two adjacent connecting webs.

15. The method of claim 1, wherein expanding the plurality of positioning arches occurs before expanding the plurality of retaining arches.

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

17. The method of claim 1, wherein the plurality of positioning arches consists of three and only three positioning arches.

18. A method of implanting an endoprosthesis adjacent a native valve having a plurality of native valve leaflets, the endoprosthesis including a plurality of first arches, each first arch having a closed proximal end and an open distal end, a plurality of second arches, and a prosthetic valve attached directly to the plurality of second arches, the method comprising:

expanding the plurality of first arches from a collapsed configuration to an expanded configuration while holding the plurality of second arches in a collapsed configuration;

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

expanding the plurality of second arches from the collapsed configuration to an expanded configuration after positioning the plurality of first arches within the respective pockets of the native valve.

19. The method of claim 18, wherein the prosthetic valve extends from the plurality of second arches transversely across an interior of the endoprosthesis.

20. The method of claim 18, further including maneuvering the endoprosthesis through a patient'"'"'s vasculature toward the patient'"'"'s heart to position the endoprosthesis adjacent the native valve.

21. The method of claim 20, further including maneuvering the endoprosthesis through a femoral artery and an aortic artery to position the endoprosthesis adjacent the native valve.

22. The method of claim 18, further including maneuvering the endoprosthesis through a wall of the patient'"'"'s heart to position the endoprosthesis adjacent the native valve.

23. The method of claim 18, further including clamping the at least one native valve leaflet with the at least one first arch and the at least one second arch.

24. The method of claim 18, further including pressing the at least one native valve leaflet against the vessel wall.

25. The method of claim 18, wherein expanding the plurality of first arches includes releasing the plurality of first arches from a catheter.

26. The method of claim 25, wherein the plurality of first arches self-expand.

27. The method of claim 18, wherein expanding the plurality of first arches includes releasing the plurality of second arches from a catheter.

28. The method of claim 27, wherein the plurality of second arches self-expand.

29. The method of claim 18, wherein each first arch is associated with a corresponding second arch and has a distal end portion axially aligned, along a longitudinal direction of the endoprosthesis, with and joined to a distal end portion of the corresponding second arch.

30. The method of claim 18, wherein radially outer most portions of the endoprosthesis are defined by the plurality of first arches and the plurality of second arches.

31. The method of claim 18, wherein each second arch has a closed proximal end and an open distal end, and the closed end of each of the plurality of first arches is substantially axially aligned along a longitudinal direction of the endoprosthesis with a closed end of a corresponding second arch.

32. The method of claim 18, wherein each first arch includes a pair of arms connected to one another at the closed proximal end, each arm of a first arch connected at a distal end thereof to a respective connecting web, such that each first arch defines a single apex between two adjacent connecting webs, and wherein each second arch includes a pair of arms connected to one another forming a distal open end and a proximal closed end, each arm of a second arch connected at a distal end thereof to a respective connecting web, such that each second arch defines a single apex between two adjacent connecting webs.

33. The method of claim 18, wherein the native valve is an aortic valve.

34. The method of claim 18, wherein the plurality of first arches consists of three and only three first arches.

35. A method of implanting an endoprosthesis having a plurality of first arches, each first arch having an open distal end and a closed proximal end, a plurality of second arches, and a prosthetic valve sutured to the plurality of second arches and extending transversely across an interior of the endoprosthesis, the method comprising:

maneuvering the endoprosthesis in a collapsed configuration to a position adjacent a native valve, the native valve including a plurality of native valve leaflets;

radially expanding the plurality of first arches from a collapsed configuration to an expanded configuration, while holding the plurality of second arches in a collapsed configuration;

maneuvering the endoprosthesis with the plurality of first arches expanded relative to the native valve to position the closed proximal end of each of the plurality of first arches within a respective pocket of the native valve such that the respective open ends of the plurality of first arches project away from the respective pocket;

radially expanding the plurality of second arches from a collapsed configuration to an expanded configuration to engage at least a portion of the native valve leaflets on a radially inward side with the plurality of second arches.

36. The method of claim 35, further including maneuvering the endoprosthesis, with the plurality of first arches in the expanded configuration and the plurality of second arches in the collapsed configuration, relative to the native valve to align the closed proximal end of each of the plurality of first arches with a respective pocket of the native valve.

37. The method of claim 35, further including engaging the pockets of the native valve with respective closed ends of the plurality of first aches when the plurality of first arches are in the expanded configuration and the plurality of second arches are in the collapsed configuration.

38. The method of claim 35, further including maneuvering the endoprosthesis through a patient'"'"'s vasculature toward the patient'"'"'s heart to position the endoprosthesis adjacent the native valve.

39. The method of claim 35, further including maneuvering the endoprosthesis through a femoral artery and an aortic artery to position the endoprosthesis adjacent the native valve.

40. The method of claim 35, further including maneuvering the endoprosthesis through a wall of the patient'"'"'s heart to position the endoprosthesis adjacent the native valve.

41. The method of claim 35, further including engaging at least a portion of the native valve leaflets on a radially outward side with the plurality of first arches.