Systems for implanting an endoprosthesis

• US 9,788,945 B2
• Filed: 03/21/2017
• Issued: 10/17/2017
• 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:
  US15/464,891
• Publication Number:
  US 20170189184A1
• Time in Patent Office: 210 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

The invention relates to a catheter for the transvasculur implantation of prosthetic heart valves, in particular comprising self-expanding anchorage supports (10), which allow a minimally invasive implantation of prosthetic heart valves. The aim of the invention is to reduce the risk to the patient during the implantation. To achieve this, according to the invention a prosthetic heart valve comprising anchorage supports is temporarily housed in a folded form in a cartridge-type unit (4) riming the implantation. The cartridge-type unit can be fixed on the proximal end of a guide system (1), which comprises a flexible region (9) that can be guided through the aorta. Actuating elements (2, 3) run through the interior of the hollow guide system, said elements 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 system comprising:

a prosthetic heart valve including a heart valve prosthesis attached to an anchoring support, wherein the anchoring support includes (1) a first portion and (2) a second portion having eyes at an end of the anchoring support;

a guide system for transvascular delivery of the prosthetic heart valve, the guide system comprising;

a cartridge at a proximal end of the guide system, the cartridge including an outer sleeve, an inner sleeve, and a part, wherein the inner sleeve has anchoring elements for engaging the eyes of the second portion of the anchoring support, and the outer sleeve is arranged to cover the anchoring elements and the eyes when the prosthetic heart valve is in a collapsed state; and

a manipulating part at a distal end of the guide system, the manipulating part comprising;

a tube having outer threads;

a second actuator adjacent the tube and moveable in a proximal-to-distal direction to allow movement of the outer sleeve and the inner sleeve relative to one another and thereby deploy at least the second portion of the prosthetic heart valve; and

a first actuator engaging the threads of the tube to rotate about a longitudinal axis of the tube to cause relative axial movement between the outer sleeve and the part of the cartridge to deploy at least the first portion of the prosthetic heart valve.

2. The system of claim 1, wherein the manipulating part includes a stop to limit proximal movement of the tube relative to another portion of the manipulating part.

3. The system of claim 1, wherein the heart valve prosthesis is an aortic valve prosthesis, the anchoring support is self-expanding, and the heart valve prosthesis is stitched to the anchoring support.

4. The system of claim 1, wherein the eyes include exactly two eyes at a distalmost end of the anchoring support.

5. The system of claim 1, wherein the outer sleeve covers the inner sleeve and the prosthetic heart valve, when the prosthetic heart valve is in the collapsed state.

6. The system of claim 1, wherein rotation of the first actuator about the tube is independent of movement of the second actuator in the proximal-to-distal direction.

7. The system of claim 1, wherein the outer sleeve and the inner sleeve are arranged so that, when a part of the prosthetic heart valve is partially deployed and the anchoring elements remain engaged with the eyes of the anchoring support, the part of the prosthetic heart valve may be retracted back within the outer sleeve.

8. A system comprising:

an endoprosthesis having a prosthetic heart valve and an anchoring support, the anchoring support having a first portion and a second portion, wherein the second portion has eyes defining holes; and

a catheter for transvascular delivery of the endoprosthesis, the catheter comprising;

a cartridge at a proximal end of the catheter, the cartridge including an inner sleeve, an outer sleeve, and a part, wherein the inner sleeve includes anchoring elements for engaging the eyes, and 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, the first portion of the endoprosthesis may be retracted back within the outer sleeve; and

a manipulating part at a distal end of the catheter, the manipulating part comprising a tube having outer threads, a first actuator engaging the outer threads of the tube, and a second actuator adjacent the tube, wherein rotation of the first actuator about a longitudinal axis of the tube deploys the first portion of the endoprosthesis, and movement of the second actuator laterally allows deployment of the second portion of the endoprosthesis, and

wherein the rotation of the first actuator is independent of the movement of the second actuator laterally.

9. The system of claim 8, wherein the eyes engage the anchoring elements to anchor the endoprosthesis to the catheter.

10. The system of claim 8, wherein when the endoprosthesis is in a collapsed form, the outer sleeve covers the eyes and the anchoring elements.

11. The system of claim 8, wherein the manipulating part further comprises:

a stop to limit proximal movement of the tube relative to another portion of the manipulating part; and

a fluid port located proximally of the first actuator and the second actuator.

12. The system of claim 8, wherein the prosthetic heart valve is an aortic valve prosthesis, the endoprosthesis is self-expanding, and the prosthetic heart valve is stitched to the second portion.

13. The system of claim 8, wherein the eyes include exactly two eyes at a distalmost end of the anchoring support.

14. The system 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 system comprising:

a prosthetic heart valve including a heart valve prosthesis attached to a self-expandable support, wherein the anchoring support includes eyes at a distalmost end of the anchoring support; and

a catheter having a proximal end and a distal end, the catheter comprising;

a cartridge at the proximal end of the catheter, the cartridge including an inner sleeve, an outer sleeve, and a part, wherein the inner sleeve includes anchoring elements for engaging the eyes of the anchoring support, and the outer sleeve covers the anchoring elements and the eyes when the prosthetic heart valve is in a collapsed state; and

a manipulating part at the distal end of the catheter, the manipulating part comprising;

a tube having outer threads;

a first actuator engaging the outer threads of the tube to rotate about a longitudinal axis of the tube to cause relative axial movement between the outer sleeve and the part of the cartridge to expand a first portion of the prosthetic heart valve while maintaining a second portion in a collapsed form, the second portion including the eyes that engage anchoring elements of the cartridge to anchor the prosthetic heart valve to the catheter; and

a second actuator adjacent the tube and moveable in a lateral direction.

16. The system of claim 15, wherein rotation of the first actuator about the tube is independent of movement of the second actuator in the lateral direction.

17. The system of claim 15, wherein the outer sleeve and the inner sleeve are arranged so that, when the first portion of the prosthetic heart valve is expanded and the anchoring elements remain engaged with the eyes of the second portion, the first portion of the prosthetic heart valve may be retracted back within the outer sleeve.

18. The system of claim 15, wherein the manipulating part includes a stop to limit proximal movement of the tube relative to another portion of the manipulating part.

19. The system of claim 15, wherein the second actuator is moveable in the lateral direction to permit the outer sleeve and the inner sleeve to move relative to one another and thereby expand the second portion of the prosthetic heart valve and release the prosthetic heart valve from the anchoring elements.

20. The system of claim 15, wherein the eyes include exactly two eyes at a distalmost end of the second portion.