Medical device for treating a heart valve insufficency

• US 9,339,386 B2
• Filed: 02/06/2014
• Issued: 05/17/2016
• Est. Priority Date: 04/13/2007
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: 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:
  US14/174,441
• Publication Number:
  US 20140222143A1
• Time in Patent Office: 831 Days
• Field of Search: 623/2.14
• US Class Current: 1/1
• 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 a native heart valve, the method comprising:

expanding a plurality of first arches from a collapsed configuration to an expanded configuration while holding a plurality of second arches in a collapsed configuration, each first arch being directly connected to an adjacent first arch;

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

after positioning the expanded plurality of first arches, expanding the plurality of second arches from the collapsed configuration to an expanded configuration, the plurality of second arches being coupled to a prosthetic valve; and

engaging the at least one native leaflet with at least one first arch of the plurality of first arches and at least one second arch of the plurality of second arches;

wherein the prosthetic valve is not attached to the plurality of first arches.

2. The method of claim 1, further comprising introducing the plurality of first arches into a femoral artery and advancing the plurality of first arches to a position adjacent the native heart valve.

3. The method of claim 1, further comprising introducing the plurality of second arches into a femoral artery and advancing the plurality of second arches to a position adjacent the native heart valve.

4. The method of claim 1, wherein the plurality of first arches self-expand.

5. The method of claim 1, wherein each first arch has an apex pointing towards a native heart.

6. The method of claim 1, wherein each second arch has an apex pointing towards a native heart.

7. The method of claim 1, wherein a distal portion of at least one of the first arches includes an attachment element, the method further comprising releasing the attachment element from a catheter.

8. The method of claim 7, wherein each of three first arches includes an attachment element, the method comprising releasing each of the attachment elements from the catheter.

9. The method of claim 1, wherein engaging the at least one native leaflet includes clamping the at least one native leaflet between at least one first arch of the plurality of first arches and at least one second arch of the plurality of second arches.

10. The method of claim 1, wherein engaging the at least one native leaflet with at least one first arch of the plurality of first arches and at least one second arch of the plurality of second arches anchors the plurality of first arches and the plurality of second arches relative to the native heart valve.

11. The method of claim 1, wherein the prosthetic valve is fixedly attached to the plurality of second arches.

12. The method of claim 1, wherein the plurality of first arches and the plurality of second arches are components of an integral structure.

13. A method of treating a native heart valve, the method comprising:

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

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

after positioning the expanded plurality of first arches, expanding the plurality of second arches from the collapsed configuration to an expanded configuration, the plurality of second arches being coupled to a prosthetic valve; and

clamping the at least one native leaflet between at least one first arch of the plurality of first arches and at least one second arch of the plurality of second arches.

14. The method of claim 13, further comprising pressing at least a portion of the at least one native leaflet against the vessel wall.

15. The method of claim 13, wherein the plurality of first arches comprises a shape memory material.

16. The method of claim 13, wherein the plurality of first arches includes at least three first arches.

17. A method of treating a native heart valve, the method comprising:

expanding a plurality of first arches from a collapsed configuration to an expanded configuration while holding a plurality of second arches and third arches in a collapsed configuration, each second arch and each third arch pointing in a same direction;

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

after positioning the expanded plurality of first arches, expanding the plurality of second arches and third arches from the collapsed configuration to an expanded configuration, the plurality of second arches being coupled to a prosthetic valve; and

engaging the at least one native leaflet with at least one first arch of the plurality of first arches and at least one second arch of the plurality of second arches;

wherein each second arch has an apex axially aligned with an apex of one of the third arches to define a space therebetween.

18. The method of claim 17, wherein the plurality of third arches are proximal to the plurality of second arches.

19. The method of claim 17, wherein the prosthetic valve is not connected to the plurality of first arches or the plurality of third arches.

20. The method of claim 17, wherein engaging the at least one native leaflet includes clamping the at least one native leaflet between at least one first arch of the plurality of first arches and at least one second arch of the plurality of second arches.