Medical device for treating a heart valve insufficiency

• US 7,896,915 B2
• Filed: 04/13/2007
• Issued: 03/01/2011
• 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, Figulla, Hans-Reiner, Ferrari, Markus
• Primary Examiner(s): McDermott; Corrine M
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US11/785,072
• Publication Number:
  US 20080255660A1
• Time in Patent Office: 1,418 Days
• Field of Search: 623/2.14, 623/2.17, 623/2.18, 623/1.15, 623/1.16, 623/1.24
• 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. Medical device for treating a native heart valve having a plurality of native valve leaflets, comprising:

an endoprosthesis having a plurality of positioning arches configured to be respectively positioned within a plurality of pockets of the native heart valve on a first side of the plurality of native valve leaflets and a plurality of retaining arches configured to be positioned on a second side of the plurality of native valve leaflets such that the plurality of native valve leaflets are positioned radially inward of at least a portion of the plurality of positioning arches and positioned radially outward of at least a portion of the plurality of retaining arches when the medical device is implanted, wherein each retaining arch is associated with a corresponding positioning 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 positioning arch; and

a prosthetic valve attached to the plurality of retaining arches such that at least part of the prosthetic valve extends from the plurality of retaining arches transversely across an interior of the endoprosthesis.

2. Medical device as claimed in claim 1, in which each positioning arch includes a substantially U-shaped or V-shaped structure.

3. Medical device as claimed in claim 1, in which each retaining arch includes a substantially U-shaped or V-shaped structure.

4. Medical device as claimed in claim 1, in which the distal end portion of the corresponding positioning arch is joined to the distal end portion of the corresponding retaining arch by a connecting web extending substantially in the longitudinal direction of the endoprosthesis.

5. Medical device as claimed in claim 1, in which the endoprosthesis further includes at least one eye-shaped element at the distal end of the endoprosthesis, the at least one eye-shaped element configured to be engaged with an introduction catheter system.

6. Medical device as claimed in claim 5, in which the at least one eye-shaped element is fixedly connected to and disposed substantially between two adjacent positioning arches.

7. Medical device as claimed in claim 6, in which the at least one eye-shaped element is disposed substantially between two adjacent retaining arches and fixedly connected to respective arms of the two adjacent retaining arches via a connecting web, the connecting web extending substantially in the longitudinal direction of the endoprosthesis.

8. Medical device as claimed in claim 6, in which the two adjacent positioning arches are indirectly joined by a connecting web extending substantially in the longitudinal direction of the endoprosthesis to the at least one eye-shaped element.

9. Medical device as claimed in claim 6, in which the at least one eye-shaped element includes at least one barb having a tip pointing in the direction of the proximal end of the endoprosthesis.

10. Medical device as claimed in claim 1, in which each of the plurality of retaining arches includes a pair of arms, the device further including a plurality of anchoring arches disposed circumferentially between and directly connected to respective arms of two adjacent retaining arches.

11. Medical device as claimed in claim 10, in which each of the anchoring arches includes a substantially U-shaped or V-shaped structure, which is closed at a distal end and including arms extending therefrom toward a proximal end and being joined to respective arms of two adjacent retaining arches.

12. Medical device as claimed in claim 1, in which each of the respective retaining arches includes a pair of arms having slots provided therein.

13. Medical device as claimed in claim 12, in which each of the respective retaining arches includes a reinforcing portion which interrupts a respective slot.

14. Medical device as claimed in claim 1, in which the endoprosthesis includes a first collapsed mode when the medical device is being introduced into the patient'"'"'s body and a second expanded mode when the medical device is in the implanted state.

15. Medical device as claimed in claim 14, in which the endoprosthesis has a concave shape tapering in the direction of the proximal end of the endoprosthesis when the endoprosthesis is in the second mode.

16. Medical device as claimed in claim 15, in which the distal end of the endoprosthesis has a diameter that is approximately 10% to 25% bigger than the diameter of the proximal end of the endoprosthesis when the endoprosthesis is in the second mode.

17. Medical device as claimed in claim 15, in which the proximal end of the endoprosthesis has a diameter of between approximately 22 mm and approximately 33 mm in the second mode.

18. Medical device as claimed in claim 15, in which the proximal end of the endoprosthesis has a diameter of between approximately 25 mm and approximately 31 mm.

19. Medical device as claimed in claim 14, in which the endoprosthesis has an external diameter of approximately 5.0 mm and a length between approximately 33.0 mm and approximately 40.0 mm when in the first mode.

20. Medical device as claimed in claim 14, in which the endoprosthesis has a length between approximately 34.0 mm and approximately 39.0 mm when in the first mode.

21. Medical device as claimed in claim 1, in which the endoprosthesis is made from a shape memory material so that the endoprosthesis can be expanded from a collapsed shape to an expanded shape under the effect of an external stimulus.

22. Medical device as claimed in claim 21, in which the external stimulus is a settable switching temperature.

23. Medical device as claimed in claim 22, in which the switching temperature is approximately 22°

C.

24. Medical device as claimed in claim 1, in which the plurality of positioning arches are expandable from a first collapsed mode to a second expanded mode independently from the plurality of retaining arches.

25. Medical device as claimed in claim 1, in which the endoprosthesis is integrally cut from a metal tube.

26. Medical device as claimed in claim 1, in which the plurality of positioning arches are configured to expand from a collapsed mode to an expanded form.

27. Medical device as claimed in claim 1, in which the endoprosthesis is configured to at least partially clamp the native valve leaflets when implanted.

28. Medical device as claimed in claim 1, wherein the prosthetic valve is sutured to the plurality of retaining arches.

29. Medical device as claimed in claim 1, wherein radially outer most portions of the endoprosthesis are defined by the plurality of positioning arches and the plurality of retaining arches.

30. Medical device as claimed in claim 1, wherein an apex of each of the plurality of positioning arches is substantially axially aligned along the longitudinal direction of the endoprosthesis with an apex of a corresponding retaining arch.

31. A medical device for treating a native heart valve having a plurality of native valve leaflets, comprising:

an endoprosthesis having a plurality of positioning arches configured to be respectively positioned within a plurality of pockets of the native heart valve on a radially outward side of the plurality of native valve leaflets;

the endoprosthesis having a plurality of retaining arches configured to be positioned on a radial inward side of the plurality of native valve leaflets;

the endoprosthesis having a plurality of connecting webs joining the plurality of positioning arches directly to the plurality of retaining arches; and

a prosthetic valve attached to the plurality of retaining arches and extending from the plurality of retaining arches transversely across an interior of the endoprosthesis;

wherein each positioning 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 positioning arch defines a single apex between two adjacent connecting webs;

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.

32. The medical device as claimed in claim 31, in which each positioning arch includes a substantially U-shaped or V-shaped structure.

33. The medical device as claimed in claim 31, in which each retaining arch includes a substantially U-shaped or V-shaped structure.

34. The medical device as claimed in claim 31, further including slots formed in each of the respective arms of the plurality of retaining arches.

35. The medical device as claimed in claim 34, further including a reinforcing portion formed in each of the respective arms of the plurality of retaining arches that interrupts a respective slot.

36. The medical device as claimed in claim 31, in which the endoprosthesis includes a first collapsed mode when the medical device is being introduced into the patient'"'"'s body and a second expanded mode when the medical device is in the implanted state.

37. The medical device as claimed in claim 36, in which the endoprosthesis has a concave shape tapering in the direction of the proximal end of the endoprosthesis when the endoprosthesis is in the second mode.

38. The medical device as claimed in claim 31, in which the plurality of positioning arches are configured to expand from a collapsed mode to an expanded mode independently from the plurality of retaining arches.

39. The medical device as claimed in claim 31, in which the endoprosthesis is configured to at least partially clamp the native valve leaflets radially between the positioning arches and retaining arches.

40. The medical device as claimed in claim 31, wherein the prosthetic valve is sutured to the plurality of retaining arches.

41. The medical device as claimed in claim 31, wherein the radially outer most portions of the endoprosthesis are defined by the plurality of positioning arches and the plurality of retaining arches.

42. The medical device as claimed in claim 31, wherein an apex of each of the plurality of positioning arches is substantially axially aligned along the longitudinal direction of the endoprosthesis with an apex of a corresponding retaining arch.

43. A medical device for treating a native heart valve, comprising an endoprosthesis having a plurality of positioning arches configured to be respectively positioned within a plurality of pockets of a native heart valve and a plurality of retaining arches;

wherein each positioning arch includes a pair of arms defining a distal open end and a proximal closed end;

wherein each retaining arch includes a pair of arms defining a distal open end and a proximal closed end;

wherein the endoprosthesis includes a first collapsed mode when the medical device is being introduced into a patient'"'"'s body and a second expanded mode when the medical device is implanted;

wherein the proximal closed end of each of the plurality of positioning arches is positioned, along an axial direction of the endoprosthesis, closer to the proximal closed end of a respective retaining arch than the distal open end of the respective retaining arch when the endoprosthesis is implanted;

wherein each of the plurality of positioning arches is axially aligned along the longitudinal direction of the endoprosthesis with a corresponding retaining arch; and

wherein a heart valve prosthesis is directly attached to the plurality of retaining arches.

44. The medical device as claimed in claim 43, in which each positioning arch includes a substantially U-shaped or V-shaped structure.

45. The medical device as claimed in claim 43, in which each retaining arch includes a substantially U-shaped or V-shaped structure.

46. The medical device as claimed in claim 43, further including slots formed in each of the respective arms of the plurality of retaining arches.

47. The medical device as claimed in claim 46, further including a reinforcing portion formed in each of the respective arms of the plurality of retaining arches that interrupts a respective slot.

48. The medical device as claimed in claim 43, in which the endoprosthesis has a concave shape tapering in the direction of the proximal end of the endoprosthesis when the endoprosthesis is in the second mode.

49. The medical device as claimed in claim 43, in which the plurality of positioning arches are configured to expand from a collapsed mode to an expanded form independently from the plurality of retaining arches.

50. The medical device as claimed in claim 43, in which the endoprosthesis is configured to at least partially clamp the native valve leaflets radially between the positioning arches and retaining arches.

51. The medical device as claimed in claim 43, wherein the heart valve prosthesis is sutured to the plurality of retaining arches.

52. The medical device as claimed in claim 43, wherein the heart valve prosthesis extends from the plurality of retaining arches transversely across an interior of the endoprosthesis.

53. The medical device as claimed in claim 43, wherein radially outer most portions of the endoprosthesis are defined by the plurality of positioning arches and the plurality of retaining arches.