Medical device for treating a heart valve insufficiency

• US 10,543,084 B2
• Filed: 02/06/2018
• Issued: 01/28/2020
• 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): Schall, Matthew W
• Application Number:
  US15/889,959
• Publication Number:
  US 20190008637A1
• Time in Patent Office: 721 Days
• 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 a 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:

introducing an endoprosthesis into a patient'"'"'s vasculature through a femoral artery in a proximal direction towards the native heart valve, wherein the endoprosthesis includes a plurality of first arches, each first arch having an apex pointing in the proximal direction;

positioning the plurality of first arches of the endoprosthesis relative to the native heart valve by placing the apex of each first arch within a respective pocket of the native heart valve, each first arch having an open end opposite the apex and joined to an open end of an adjacent first arch; and

positioning a plurality of second arches of the endoprosthesis radially inward of the plurality of first arches, such that the native heart valve is positioned radially inward of at least a portion of the plurality of first arches and radially outward of at least a portion of the plurality of second arches;

wherein the endoprosthesis includes a prosthetic valve attached to the plurality of second arches, and at least part of the prosthetic valve extends from the plurality of second arches transversely across an interior of the endoprosthesis.

2. The method of claim 1, wherein the endoprosthesis comprises a shape-memory material.

3. The method of claim 1, wherein the endoprosthesis is self-expandable.

4. The method of claim 1, wherein positioning the plurality of first arches includes expanding the plurality of first arches while the plurality of second arches is in a collapsed state.

5. The method of claim 1, wherein positioning the plurality of second arches includes applying radial force against the plurality of first arches.

6. The method of claim 1, wherein the plurality of first arches is indirectly connected to the plurality of second arches by a plurality of connecting webs.

7. The method of claim 6, wherein each connecting web of the plurality of connecting webs is oriented in a longitudinal direction of the endoprosthesis and disposed between two adjacent first arches.

8. The method of claim 6, wherein the plurality of connecting webs includes exactly three connecting webs.

9. The method of claim 1, wherein the plurality of first arches and the plurality of second arches are integrally connected.

10. The method of claim 1, wherein each first arch of the plurality of first arches has a U-shaped or V-shaped structure.

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

12. The method of claim 1, wherein positioning the plurality of first arches includes releasing the plurality of first arches from a catheter system while the plurality of second arches is disposed inside the catheter system.

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

positioning an endoprosthesis proximate the native heart valve, the endoprosthesis extending from a proximal end to a distal end;

positioning a plurality of first arches of the endoprosthesis relative to the native heart valve by placing an apex of each first arch within a corresponding pocket of the native heart valve on a first side of a plurality of native valve leaflets, wherein the plurality of first arches points in a proximal direction, and the distal end of the endoprosthesis is distal to the plurality of first arches and points in a distal direction opposite the proximal direction, and wherein each first arch has a U-shape and an open end opposite the apex joined to an open end of an adjacent first arch; and

positioning a plurality of second arches of the endoprosthesis on a second side of the plurality of native valve leaflets, such that the native heart valve is positioned radially inward of at least a portion of the plurality of first arches and radially outward of at least a portion of the plurality of second arches, the plurality of first arches being connected to the plurality of second arches by connecting webs;

wherein a prosthetic valve is attached to the plurality of second arches of the endoprosthesis, such that at least part of the prosthetic valve extends transversely across an interior of the endoprosthesis.

14. The method of claim 13, wherein the native heart valve includes exactly three native valve leaflets.

15. The method of claim 13, wherein positioning the plurality of first arches of the endoprosthesis includes rotating the endoprosthesis relative to the native heart valve, such that the apex of each first arch engages the corresponding pocket of the native heart valve.

16. The method of claim 13, wherein positioning the plurality of first arches includes releasing the plurality of first arches from a catheter system while the plurality of second arches is disposed inside the catheter system.

17. The method of claim 13, wherein the plurality of first arches is connected to the plurality of second arches by exactly three connecting webs oriented in a longitudinal direction of the endoprosthesis.

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

positioning an endoprosthesis relative to the native heart valve by advancing a proximal end of the endoprosthesis through an aortic arch towards the native heart valve, the endoprosthesis comprising three first arches and a plurality of second arches, wherein positioning the endoprosthesis includes;

placing an apex of each first arch within a corresponding pocket of the native heart valve by moving the proximal end of the endoprosthesis towards the native heart valve, such that the plurality of first arches is radially outward of three native valve leaflets of the native heart valve, each first arch having an open end opposite the apex and joined to an open end of an adjacent first arch; and

placing the plurality of second arches radially inward of the three native valve leaflets, the three first arches being coupled to the plurality of second arches by three connecting webs;

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

19. The method of claim 18, wherein the apex of each first arch has a U-shaped or V-shaped structure.

20. The method of claim 18, wherein placing the apex of each first arch within the corresponding pocket of the native heart valve is performed while the plurality of second arches is in a collapsed state.