Medical device for treating a heart valve insufficiency

• US 20080255660A1
• Filed: 04/13/2007
• Published: 10/16/2008
• 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
• Granted Patent: US 7,896,915 B2
• Time in Patent Office: Days
• 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 heart valve insufficiency, 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 configured to support a heart valve prosthesis, wherein each retaining arch is associated with each positioning arch and each distal end portion of a respective positioning arch is joined to a distal end portion of an associated retaining arch.

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 a distal end portion of a positioning arch is joined to a distal end portion of an adjacent 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 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 between 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 of the 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 slots are provided in each of the respective arms of the plurality of retaining arches.

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 1, further comprising a heart valve prosthesis attached to the plurality of retaining arches.

19. 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 a an expanded shape under the effect of an external stimulus.

20. Medical device as claimed in claim 19, in which the external stimulus is a settable switching temperature.

21. Medical device as claimed in claim 20, in which the switching temperature is approximately 22°

C.

22. 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.

23. 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.

24. 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.

25. 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.

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

27. 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 and be positioned within pockets of a native heart valve.

28. Medical device as claimed in claim 1, in which the endoprosthesis is configured to position flaps of the native heart valve between the positioning arches and the retaining arches.

29. A stent comprising:

a plurality of first elements each including first and second arms connected at respective distal ends thereof to one another, forming a plurality of first closed ends, and connected at respective proximal ends thereof to a respective first or second arm of an adjacent first element, forming a plurality of first joints; and

a plurality of second elements each including third and fourth arms connected at respective distal ends thereof to one another, forming a plurality of second closed ends, and connected at respective proximal ends thereof to a respective third or fourth arm of an adjacent second element, forming a plurality of second joints;

wherein;

each of the plurality of first elements is joined to a respective one of the plurality of second elements via a first leg member; and

each of the plurality of first closed ends extends axially between the distal and proximal ends of a second element, and each of the plurality of second joints extends axially between the distal and proximal ends of a first element.

30. The stent of claim 29, further including a plurality of apertures, each aperture disposed adjacent a respective one of the plurality of first joints and configured to operatively connect the stent to a catheter.

31. The stent of claim 30, wherein each of the plurality of apertures is connected to a respective one of the plurality of first joints via a second leg member approximately extending along a longitudinal axis of the stent.

32. The stent of claim 30, wherein each of the plurality of apertures includes at least one barb having a tip projecting in the proximal direction.

33. The stent of claim 29, further including a plurality of third elements each including fifth and sixth arms connected at respective proximal ends thereof to one another forming a plurality of third closed ends and connected at respective distal ends thereof to a respective third or fourth arm of one of the plurality of second elements.

34. The stent of claim 33, wherein each of the first, second, and third elements includes a generally U-shaped or a V-shaped structure.

35. The stent of claim 29, wherein each of the first and second elements generally forms an arch having a generally rounded tip portion formed at a respective one of the plurality of first and second joints.

36. The stent of claim 29, wherein the stent is expandable from a collapsed mode to an expanded mode.

37. The stent of claim 36, wherein each of the plurality of first closed ends is configured to engage a pocket of a native heart valve when the stent is in the expanded mode.

38. The stent of claim 37, wherein the native heart valve is an aortic valve.

39. The stent of claim 36, wherein the plurality of second elements are configured to radially compress a native heart valve against a vessel wall when the stent is in the expanded mode.

40. The stent of claim 36, wherein the plurality of second elements are configured to radially compress the plurality of first elements against a vessel wall via a native heart valve when the stent is in the expanded mode.

41. The stent of claim 36, wherein the plurality of first and second elements are configured to clamp at least a portion of the native heart valve therebetween when the stent is in the expanded mode.

42. The stent of claim 29, wherein the plurality of first elements includes three first elements.

43. The stent of claim 29, wherein the stent is made from a shape-memory alloy.

44. The stent of claim 29, further including a valve prosthesis connected to the plurality of second elements.

45. The stent of claim 44, wherein the valve prosthesis is a naturally occurring valve.

46. The stent of claim 29, wherein each of third and fourth arms of each of the plurality of second elements includes at least one slot therein.

47. The stent of claim 29, wherein the plurality of first elements consists essentially of three arches, and the plurality of second elements consists essentially of three arches.

48. A method of implanting a stent, comprising:

cooling a stent formed from a shape memory material and maintaining the stent in a collapsed form via a catheter;

positioning the stent in the collapsed form relative to a native valve;

heating the stent above the critical temperature of the shape memory alloy and radially confining the stent via the catheter to remain in the collapsed form; and

releasing at least a first portion of the stent to radially expand the first portion.

49. The method of claim 48, wherein the first portion of the stent includes a first plurality of arches each including a closed proximal end and an open distal end, the method further including positioning each of the plurality of closed proximal ends within a respective pocket of the native valve.

50. The method of claim 49, wherein the stent further includes a second plurality of arches each including a closed proximal end and an open distal end, the method further including releasing a remainder of the stent to radially expand the remainder of the stent and radially press the native valve against a vessel wall.

51. The method of claim 50, wherein the step of releasing the remainder of the stent clamps at least a portion of the native valve between the first and second plurality of arches.

52. The method of claim 48, wherein the step of positioning the stent includes manipulating the catheter through the femoral artery toward the aortic valve.

53. The method of claim 48, wherein the step of positioning the stent includes manipulating the catheter through the heart toward the aortic valve.

54. The method of claim 48, wherein the step of cooling the stent includes supplying a stream of coolant to the stent via the catheter.

55. The method of claim 48, wherein the step of heating the stent includes interrupting a stream of coolant supplied to the stent via the catheter.

56. The method of claim 48, wherein the critical temperature is below 36°

C.

57. A method of treating an insufficiency of a native heart valve with a heart valve prosthesis supported on a stent including a plurality of first arches each having an open end joined to an open end of an adjacent first arch and a plurality of second arches each having an open end joined to an open end of an adjacent second arch, the method comprising:

positioning the plurality of first arches within pockets of the native heart valve;

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

radially compressing the at least a portion of the native heart valve against a vessel wall with the plurality of second arches to secure the heart valve prosthesis within the vessel.

58. The method of claim 57, wherein the stent is configured to expand from a collapsed mode to an expanded mode.

59. The method of claim 58, wherein the plurality of first arches are configured to expand independently of the plurality of second arches.

60. The method of claim 59, wherein the step of positioning the plurality of first arches is performed before the plurality of second arches is expanded.

61. The method of claim 57, 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.

62. The method of claim 57, wherein the heart valve prosthesis is a naturally occurring valve.

63. A method of making a self-expanding stent including a plurality of first arches and a plurality of second arches, each first arch associated with a respective second arch, the stent being configured to be introduced into a patient'"'"'s body in a collapsed mode and configured to clamp at least a portion of a native heart valve between the plurality of first arches and the plurality of second arches in an expanded mode, the method comprising:

cutting the stent integrally from a metal tube;

shaping the stent; and

heat treating the stent so that the stent can be transferred from a collapsed mode to an expanded mode.

64. The method of claim 63, wherein the steps of shaping the stent and heat treating the stent are separate steps.

65. The method of claim 63, wherein the step of cutting the stent includes laser cutting the stent integrally from a metal tube.

66. The method of claim 63, wherein each of the plurality of first arches includes an open distal end and is respectively joined to at least another one of the plurality of first arches at a distal end.

67. The method of claim 63, wherein each of the plurality of second arches includes an open distal end and is respectively joined to at least another one of the plurality of second arches at a distal end.

68. The method of claim 63, wherein each of the plurality of first arches is joined to at least one of the plurality of second arches via a web, the web being formed during the step of cutting the stent integrally from the metal tube.

69. The method of claim 63, wherein each of the plurality of first arches includes a closed proximal end, and each of the plurality of second arches includes a closed proximal end, each of the closed proximal ends being formed during the step of cutting the stent integrally from the metal tube.

70. The method of claim 63, wherein the stent includes a plurality of locating eyes being formed during the step of cutting the stent integrally from the metal tube.

71. The method of claim 63, wherein the stent includes a plurality of slots located in respective arms of the plurality of second arches being formed during the step of cutting the stent integrally from the metal tube.