Methods of implanting an endoprosthesis

• US 9,775,705 B2
• Filed: 01/30/2014
• Issued: 10/03/2017
• Est. Priority Date: 01/20/2005
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Ottma, Rdiger, Moszner, Robert, Figulla, Hans-Reiner, Ferrari, Markus, Damm, Christoph
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US14/168,976
• Publication Number:
  US 20140214153A1
• Time in Patent Office: 1,342 Days
• 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 described 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 with 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 includes 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. A method of implanting an endoprosthesis with a catheter system, the system including a cartridge at a proximal end of the system, the cartridge including an inner sleeve, an outer sleeve, and a part, the method comprising:

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

rotating a first actuator to cause relative movement between the outer sleeve and the part of the cartridge to expand a first portion of the endoprosthesis while maintaining a second portion in the collapsed form, the second portion having eyes defining holes that engage anchoring elements of the catheter system to anchor the endoprosthesis to the catheter system; and

actuating a second actuator to permit relative axial movement between the outer sleeve and the inner sleeve, expansion of the second portion, and release of the endoprosthesis from the catheter system such that the endoprosthesis is in an expanded form.

2. The method of claim 1, wherein the second portion is at a distal end of the endoprosthesis, and the first portion is at a proximal end of the endoprosthesis.

3. The method of claim 1, wherein the outer sleeve and the inner sleeve are arranged so that, when the first portion of the endoprosthesis is expanded and the anchoring elements remain engaged with the eyes of the second portion, the first portion of the endoprosthesis may be retracted back within the outer sleeve.

4. The method of claim 1, wherein the catheter system further includes a manipulating part at a distal end of the catheter system, the manipulating part including a tube having outer threads, and wherein actuation of the first actuator about the tube is independent of the actuation of the second actuator about the tube.

5. The method of claim 4, wherein the manipulating part includes a stop to limit proximal movement of the tube relative to another portion of the manipulating part.

6. The method of claim 1, wherein the eyes include exactly two eyes at a distalmost end of the second portion of the endoprosthesis.

7. The method of claim 1, wherein the endoprosthesis includes a heart valve prosthesis, wherein the heart valve prosthesis is an aortic valve prosthesis, the endoprosthesis is self-expanding, and the heart valve prosthesis is stitched to the second portion.

8. A method of implanting an endoprosthesis with a catheter system, the catheter system including a manipulating part at a distal end of the catheter system, the manipulating part including a tube having outer threads, a first actuator engaging the outer threads of the tube, and a second actuator adjacent the tube, wherein actuation of the first actuator includes rotation about a longitudinal axis of the tube, and actuation of the second actuator results in axial movement of the second actuator in a proximal-to-distal direction, and wherein rotation of the first actuator about the longitudinal axis of the tube is independent of the actuation of the second actuator, the method comprising:

positioning a cartridge unit relative to a 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, a second sleeve-shaped element, and a part, and wherein at least a portion of the second sleeve-shaped element being radially inward of the first sleeve-shaped element;

rotating the first actuator about the longitudinal axis of the tube to cause relative movement between the first sleeve-shaped element and the part of the cartridge unit to allow a first portion of the endoprosthesis to expand while maintaining a second portion of the endoprosthesis housed within the cartridge unit, wherein the second portion includes eyes defining holes that engage a plurality of anchoring elements of the cartridge unit to anchor the endoprosthesis to the catheter system; and

actuating the second actuator to permit relative movement between the first sleeve-shaped element and the second sleeve-shaped element to allow the second portion of the endoprosthesis to expand and release the endoprosthesis from the catheter system.

9. The method of claim 8, wherein the first sleeve-shaped element and the second sleeve-shaped element are arranged so that, when the first portion of the endoprosthesis is expanded and the anchoring elements remain engaged with the eyes of the second portion, the first portion of the endoprosthesis may be retracted back within the first sleeve-shaped element.

10. The method of claim 8, wherein when the endoprosthesis is in the collapsed form, the first-sleeve shaped element is arranged to cover the eyes of the second portion and the anchoring elements of the cartridge unit.

11. The method of claim 8, wherein the manipulating part includes a stop to limit proximal movement of the tube relative to another portion of the manipulating part.

12. The method of claim 8, wherein the eyes include exactly two eyes at a distalmost end of the second portion of the endoprosthesis.

13. The method of claim 8, wherein the endoprosthesis includes a heart valve prosthesis, wherein the heart valve prosthesis is an aortic valve prosthesis, the endoprosthesis is self-expanding, and the heart valve prosthesis is stitched to the second portion.

14. The method of claim 8, wherein the second portion is at a distal end of the endoprosthesis, and the first portion is at a proximal end of the endoprosthesis.

15. A method of implanting an endoprosthesis with a catheter system, the system including a cartridge at a proximal end of the catheter system and a manipulating part at a distal end of the catheter system, the cartridge including a first sleeve, a second sleeve, and a part, the manipulating part including a tube having outer threads, a first actuator engaging the outer threads of the tube, and a second actuator adjacent the tube, the method comprising:

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

rotating the first actuator about a longitudinal axis of the tube to cause (1) axial motion of the first actuator and (2) relative axial motion between the first sleeve and the part of the cartridge to expand a first portion of the endoprosthesis while maintaining a second portion in the collapsed form, the second portion engaging anchoring elements of the catheter system to anchor the endoprosthesis to the catheter system; and

moving the second actuator in a proximal-to-distal direction to allow relative movement between the first sleeve and the second sleeve and thereby expand the second portion of the endoprosthesis and release the endoprosthesis from the anchoring elements.

16. The method of claim 15, wherein the first sleeve and the second sleeve are arranged so that, when the first portion of the endoprosthesis is expanded and the anchoring elements remain engaged with the second portion, the first portion of the endoprosthesis may be retracted back within the first sleeve.

17. The method of claim 15, wherein rotating the first actuator about the tube is independent from moving the second actuator in the proximal-to-distal direction.

18. The method of claim 15, wherein the endoprosthesis includes a heart valve prosthesis, the heart valve prosthesis is an aortic valve prosthesis, the endoprosthesis is self-expanding, and the heart valve prosthesis is stitched to the second portion.

19. The method of claim 15, wherein the manipulating part includes a fluid port located proximally of the first actuator and the second actuator.

20. The method of claim 15, wherein the second portion includes eyes defining holes that engage the anchoring elements of the catheter system, and wherein fully expanding the endoprosthesis includes expanding the second portion of the endoprosthesis to release the eyes from the anchoring elements to release the endoprosthesis from the catheter system.