Methods of implanting an endoprosthesis

• US 20140214153A1
• Filed: 01/30/2014
• Published: 07/31/2014
• Est. Priority Date: 01/20/2005
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology GmbH (JenaValve Technology, Inc.)
• Inventors: FIGULLA, Hans-Reiner, FERRARI, Markus, DAMM, Christoph, OTTMA, Rdiger, MOSZNER, Robert
• Granted Patent: US 9,775,705 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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
• CPC Class Codes: A61F 2240/008 Means for testing implantable prostheses

Abstract

A catheter is disclosed for the transvascular implantation of prosthetic heart valves, e.g., including self-expanding anchorage supports, to reduce the risk to the patient during the implantation. Accordingly, a prosthetic heart valve comprising anchorage supports is temporarily housed in a folded form in a cartridge-type unit during the implantation. The cartridge-type unit can be fixed on the proximal end of a guide system, which comprises a flexible region that can be guided through the aorta. Actuating elements run through the interior of the hollow guide system, permitting sections of the cartridge-type unit to be displaced radially about their longitudinal axis and/or laterally in a proximal direction, thus allowing individual sections of the anchorage support and the associated prosthetic heart valve to be sequentially released.

Claims

1-16. -16. (canceled)

17. A method of implanting an endoprosthesis with a catheter system, the method comprising:

positioning the endoprosthesis relative to a native heart valve, wherein the endoprosthesis is in a collapsed form;

expanding a plurality of first elements of the endoprosthesis while maintaining a plurality of second elements in the collapsed form, the plurality of second elements having a shape complementary to a plurality of anchoring elements of the catheter system to anchor the endoprosthesis to the catheter system;

engaging the plurality of first elements with a plurality of native leaflets of the native heart valve; and

expanding the plurality of second elements to release the endoprosthesis from the catheter system such that the endoprosthesis is in an expanded form.

18. The method of claim 17, wherein the plurality of second elements are at an end of the endoprosthesis.

19. The method of claim 17, wherein each first element of the plurality of first elements has an arched shape.

20. The method of claim 17, wherein the plurality of first elements are at a proximal end of the endoprosthesis.

21. The method of claim 17, further comprising rotating the endoprosthesis into a desired position with respect to the native heart valve.

22. The method of claim 21, wherein rotating the endoprosthesis into the desired position includes determining a rotational position of the endoprosthesis via tactile feedback.

23. The method of claim 17, wherein engaging the plurality of first elements with the plurality of native leaflets includes compressing at least a portion of the native leaflets between the plurality of first elements and another portion of the endoprosthesis.

24. The method of claim 17, wherein engaging the plurality of first elements with the plurality of native leaflets includes introducing the plurality of first elements into pockets of the native heart valve.

25. The method of claim 17, wherein the endoprosthesis includes a heart valve prosthesis, and wherein expanding the plurality of second elements expands the heart valve prosthesis to function in place of the native heart valve.

26. A method of implanting an endoprosthesis with a catheter system, the method comprising:

positioning a cartridge unit relative to a native heart valve, the cartridge unit at least partially enclosing an endoprosthesis in a collapsed form, wherein the cartridge unit includes a first sleeve-shaped element and a second sleeve-shaped element, at least a portion of the second sleeve-shaped element being radially inward of the first sleeve-shaped element;

moving the first sleeve-shaped element to allow a plurality of first elements of the endoprosthesis to expand while maintaining a plurality of second elements of the endoprosthesis housed within the second sleeve-shaped element, wherein the plurality of second elements are engaged with a plurality of anchoring elements of the unit to anchor the endoprosthesis to the catheter system;

positioning the plurality of first elements adjacent a plurality of native leaflets of the native heart valve;

engaging the plurality of first elements with the plurality of native leaflets; and

moving the second sleeve-shaped element to allow a plurality of second elements of the endoprosthesis to expand and release the endoprosthesis from the catheter system.

27. The method of claim 26, further comprising advancing the cartridge unit through a bend in an aorta towards the native heart valve.

28. The method of claim 26, wherein the catheter system includes a handle coupled to the cartridge unit via a plurality of operating elements configured to effect translational movement and rotational movement of the cartridge unit.

29. The method of claim 28, wherein the first sleeve-shaped element is moved in a direction towards the handle to allow the plurality of first elements to expand.

30. The method of claim 28, wherein the second sleeve-shaped element is moved in a direction away from the handle to allow the plurality of second elements to expand.

31. The method of claim 26, wherein the endoprosthesis includes a heart valve prosthesis, and wherein moving the second sleeve-shaped element allows the heart valve prosthesis to expand to function in place of the native heart valve.

32. The method of claim 26, wherein the plurality of second elements are at an end of the endoprosthesis.

33. A method of implanting an endoprosthesis with a catheter system, the method comprising:

positioning the endoprosthesis in a collapsed form relative to a native heart valve;

partially expanding the endoprothesis to release a plurality of first elements while maintaining a plurality of second elements in the collapsed form, the plurality of second elements having a shape complementary to a plurality of anchoring elements of the catheter system to anchor the endoprosthesis to the catheter system;

engaging the plurality of first elements with at least a portion of the native heart valve; and

determining a position of the endoprosthesis via tactile feedback.

34. The method of claim 33, wherein partially expanding the endoprosthesis includes moving a sleeve-shaped element of the catheter system to allow the endoprosthesis to self-expand.

35. The method of claim 33, further comprising collapsing at least a portion of the endoprosthesis by moving a sleeve-shaped element over the endoprosthesis.

36. The method of claim 35, further comprising:

repositioning the endoprosthesis relative to the native heart valve; and

fully expanding the endoprosthesis to release the endoprosthesis from the catheter system, wherein fully expanding the endoprosthesis includes expanding the plurality of second elements to release the plurality of second elements from the plurality of anchoring elements.