Methods for treating a heart valve insufficiency or stenosis

• US 9,445,896 B2
• Filed: 07/02/2009
• Issued: 09/20/2016
• Est. Priority Date: 04/13/2007
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Straubinger, Helmut, Jung, Johannes
• Primary Examiner(s): Templeton, Christopher L
• Application Number:
  US12/496,989
• Publication Number:
  US 20100174362A1
• Time in Patent Office: 2,637 Days
• Field of Search: 623/2.11, 623/1.11, 606/108, 128/898
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor

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 with a catheter. 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 collapsed mode during the process of introducing it into the patient'"'"'s body and an expanded mode when it is implanted. The endoprosthesis may be introduced into a patient'"'"'s body and expanded via a catheter. In an embodiment, the catheter has first and second slide mechanisms configured to independently manipulate first and second sleeve elements to sequentially expand the endoprosthesis from the collapsed mode to the expanded mode.

Claims

1. A method of implanting an endoprosthesis including exactly three positioning arches, exactly three retaining arches, exactly three connecting struts, a valve prosthesis directly attached to each of the exactly three retaining arches, and a plurality of retaining elements, the method comprising:

positioning the endoprosthesis relative to a native valve;

manipulating a handle of a catheter to move a first sleeve element to uncover the positioning arches;

positioning the positioning arches within pockets of the native valve;

manipulating the handle to move a second sleeve element to uncover the retaining arches to allow the retaining arches and the valve prosthesis to expand, wherein each of the exactly three retaining arches includes an apex axially aligned along a longitudinal direction of the endoprostesis with a respective apex of one of the exactly three positioning arches;

clamping a plurality of native leaflets of the native valve between the positioning arches and the retaining arches; and

manipulating the handle to further move the first sleeve to uncover the plurality of retaining elements;

wherein each of the exactly three connecting struts connects two of the positioning arches at a first axial location along the longitudinal direction and connects two of the retaining arches at a second axial location along the longitudinal direction, different from the first axial location.

2. The method of claim 1, further including releasing a temporary stop mechanism before the step of manipulating the handle to uncover the plurality of retaining elements.

3. The method of claim 1, wherein the first sleeve element is configured to move independently of the second sleeve element.

4. The method of claim 1, further comprising moving the endoprosthesis through an aortic arch before the positioning of the endoprosthesis relative to the native valve, wherein the first sleeve element moves in a first direction to uncover the positioning arches.

5. The method of claim 4, wherein the first sleeve element moves further in the first direction to uncover the plurality of retaining elements.

6. The method of claim 4, wherein the second sleeve element moves in a second direction opposite the first direction to uncover the retaining arches.

7. The method of claim 1, wherein the uncovering of the plurality of retaining elements automatically disengages the plurality of retaining elements from a plurality of retaining pockets disposed within a retaining element of the catheter.

8. The method of claim 7, wherein each retaining element of the plurality of retaining elements includes a rounded head portion connected to a longitudinal strut, and wherein each longitudinal strut connects a pair of adjacent positioning arches of the exactly three positioning arches.

9. The method of claim 1, wherein the positioning arches self-expand when uncovered.

10. The method of claim 1, wherein the endoprosthesis includes at least one marker element visible by X-ray.

11. A method of implanting an endoprosthesis including exactly three positioning arches, exactly three retaining arches, a valve prosthesis directly attached to each of the retaining arches, and a plurality of retaining elements, the method comprising:

positioning the endoprosthesis relative to a native valve;

manipulating a catheter to uncover the positioning arches;

positioning the positioning arches within pockets of the native valve;

manipulating the catheter to uncover the retaining arches to allow the retaining arches and the valve prosthesis to expand, wherein each of the exactly three retaining arches includes a plurality of openings through which the valve prosthesis is attached, and an apex of each of the retaining arches is axially aligned along a longitudinal direction of the endoprostesis with a respective apex of one of the exactly three positioning arches; and

clamping a plurality of native leaflets of the native valve between the positioning arches and the retaining arches;

wherein, when implanted, the positioning arches are disposed radially outward of the plurality of native leaflets and the retaining arches are disposed radially inward of the plurality of native leaflets.

12. The method of claim 11, further including manipulating the catheter to uncover the plurality of retaining elements, each retaining element including a rounded head portion connected to a longitudinal strut portion, wherein a distal end of the valve prosthesis is proximal to the longitudinal strut portions of the plurality of retaining elements.

13. The method of claim 11, wherein the positioning arches self-expand when uncovered.

14. The method of claim 11, wherein the manipulating of the catheter to uncover the positioning arches includes manipulating a first sleeve of the catheter to move in a first direction.

15. The method of claim 14, wherein the manipulating of the catheter to uncover the retaining arches includes manipulating a second sleeve of the catheter to move in a second direction, opposite the first direction.

16. The method of claim 15, further including releasing a temporary locking element after the manipulating of the first sleeve and before the manipulating of the second sleeve.

17. The method of claim 15, further including manipulating the first sleeve to move further in the first direction to uncover the plurality of retaining elements.

18. The method of claim 17, further including releasing a temporary locking element on the catheter after the uncovering of the retaining arches and before the uncovering of the plurality of retaining elements.

19. The method of claim 15, further including releasing a temporary locking element on the catheter after the uncovering of the positioning arches and before the uncovering of the retaining arches.

20. A method of implanting an endoprosthesis with a catheter, the endoprosthesis including exactly three positioning arches, exactly three retaining arches each including an apex, a valve prosthesis directly attached to each of the exactly three retaining arches, and a plurality of retaining elements, the method comprising:

positioning the endoprosthesis relative to a native aortic valve;

moving a first sleeve element in a first direction to uncover the positioning arches;

positioning the positioning arches within pockets of the native aortic valve;

moving a second sleeve element in a second direction to uncover the retaining arches;

clamping a plurality of native leaflets of the native aortic valve between the positioning arches and the retaining arches; and

moving the first sleeve element further in the first direction to uncover the plurality of retaining elements;

wherein the apices of the retaining arches define a proximal-most end of the endoprosthesis; and

wherein, when implanted, the positioning arches are disposed radially outward of the plurality of native leaflets and the retaining arches are disposed radially inward of the plurality of native leaflets.

21. The method of claim 20, wherein, upon implantation of the endoprosthesis, the apex of each retaining arch of the exactly three retaining arches is axially aligned along a longitudinal direction of the endoprosthesis with a respective apex of a corresponding positioning arch of the exactly three positioning arches.

22. The method of claim 20, wherein the first direction is away from the second sleeve element along a longitudinal axis of the catheter, the plurality of retaining elements remaining covered by the first sleeve element while the positioning arches are positioned within the pockets of the native aortic valve.