Device for the implantation and fixation of prosthetic valves

• US 8,551,160 B2
• Filed: 12/09/2011
• Issued: 10/08/2013
• Est. Priority Date: 10/28/2005
• Status: Expired

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Figulla, Hans-Reiner, Ferrari, Markus, Damm, Christoph
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US13/315,913
• Publication Number:
  US 20120310336A1
• Time in Patent Office: 669 Days
• Field of Search: 623 21- 219, 623/1.24
• US Class Current: 623/2.1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular

Abstract

A device for the transvascular implantation and fixation of prosthetic heart valves having a self-expanding heart valve stent (10) with a prosthetic heart valve (11) at its proximal end is introducible into a patient'"'"'s main artery. With the objective of optimizing such a device to the extent that the prosthetic heart valve (11) can be implanted into a patient in a minimally-invasive procedure, to ensure optimal positioning accuracy of the prosthesis (11) in the patient'"'"'s ventricle, the device includes a self-expanding positioning stent (20) introducible into an aortic valve positioned within a patient. The positioning stent is configured separately from the heart valve stent (10) so that the two stents respectively interact in their expanded states such that the heart valve stent (10) is held by the positioning stent (20) in a position in the patient'"'"'s aorta relative the heart valve predefinable by the positioning stent (20).

Claims

1. A valve prosthesis, comprising:

a first stent component including (i) a first portion disposed at a proximal end of the first stent component that is positionable radially outward from at least a portion of a native leaflet of a native heart valve and radially inward of a vessel wall adjacent the native heart valve when the first stent component is implanted relative to the native heart valve, and (ii) a second portion disposed at a distal end of the first stent component, opposite the proximal end, wherein the distal end of the first stent component is positioned farther away from a native heart than the proximal end of the first stent component when the first stent component is implanted relative to the native heart valve;

a second stent component including (i) a first portion disposed at a proximal end of the second stent component that is positionable radially inward of at least a portion of the native leaflet adjacent the first portion of the first stent component when the second stent component is implanted relative to the native heart valve, and (ii) a second portion disposed at a distal end of the second stent component, opposite the proximal end, wherein the distal end of the second stent component is positioned farther away from the native heart than the proximal end of the second stent component when the second stent component is implanted relative to the native heart valve; and

a prosthetic valve component attached to the second stent component.

2. The valve prosthesis of claim 1, wherein:

the first stent component further includes an annular attachment element disposed at the distal end of the first stent component;

the second stent component further includes an annular attachment element disposed at the distal end of the second stent component; and

the annular attachment element of the first stent component engages the annular attachment element of the second stent component when the first and second stent components are implanted relative to the native heart valve.

3. The valve prosthesis of claim 2, wherein the second stent component further includes at least one strut extending in a distal direction away from the annular attachment element of the second stent component.

4. The valve prosthesis of claim 3, wherein the second stent component further includes at least one eyelet disposed at a distal end of the at least one strut and configured to be grasped by a retrieval catheter.

5. The valve prosthesis of claim 1, wherein the prosthetic valve component is attached to the second stent component at the proximal end of the second stent component.

6. The valve prosthesis of claim 1, wherein the first stent component is self expanding and includes a collapsed mode when the first stent component is being delivered to an implantation site adjacent the native valve and an expanded mode when the first stent component is implanted relative to the native heart valve.

7. The valve prosthesis of claim 1, wherein the second stent component is self-expanding and includes a collapsed mode when the second stent component is being delivered to an implantation site adjacent the native heart valve and an expanded mode when the second stent component is implanted relative to the native heart valve.

8. The valve prosthesis of claim 1, wherein the first stent component includes at least one support strut disposed at the proximal end of the first stent component that is positionable within a respective pocket of the native heart valve when the first stent component is implanted relative to the native heart valve.

9. The valve prosthesis of claim 8, wherein the at least one support strut of the first stent component is curved convexly in a proximal direction of the first stent component.

10. The valve prosthesis of claim 1, wherein the first stent component includes three support struts disposed at the proximal end of the first stent component, each support strut respectively positionable within one of three pockets of the native heart valve, the native heart valve being an aortic valve, when the first stent component is implanted relative to the native heart valve.

11. The valve prosthesis of claim 10, wherein the three support struts are substantially equally spaced from one another.

12. The valve prosthesis of claim 1, wherein the second stent component has sufficient radial strength to press the native heart valve against a wall containing the native heart valve.

13. The valve prosthesis of claim 1, wherein at least one of the first stent component and second stent component is self-expanding.

14. The valve prosthesis of claim 13, wherein both of the first stent component and second stent component are self-expanding.

15. The valve prosthesis of claim 1, wherein at least one of the first stent component and second stent component is convertible from an expanded state to a collapsed state.

16. The valve prosthesis of claim 1, wherein both of the first stent component and second stent component are convertible from an expanded state to a collapsed state.

17. The valve prosthesis of claim 1, wherein the first stent component and second stent component are rotatable relative to each other for positioning relative to the native heart valve.

18. A valve prosthesis, comprising:

a first stent component including (i) a first portion disposed at a proximal end of the first stent component that is positionable radially outward from at least a portion of a native leaflet of a native heart valve and radially inward of a vessel wall adjacent the native heart valve when the first stent component is implanted relative to the native heart valve, and (ii) a second portion disposed at a distal end of the first stent component, opposite the proximal end, wherein the distal end of the first stent component is positioned farther away from a native heart than the proximal end of the first stent component when the first stent component is implanted relative to the native valve;

a second stent component including (i) a first portion disposed at a proximal end of the second stent component that is positioned radially inward of at least a portion of the native leaflet adjacent the first portion of the first stent component when the stent is implanted relative to the native heart valve, and (ii) a second portion disposed at a distal end of the second stent component, opposite the proximal end, wherein the distal end of the second stent component is positioned farther away from the native heart than the proximal end of the second stent component when the second stem component is implanted relative to the native heart valve; and

a prosthetic valve component attached to the second stent component at the proximal end of the second stent component;

wherein the first portion of the first stent component and the first portion of the second stent component are configured to clamp at least a portion of the native leaflet.

19. The valve prosthesis of claim 18, wherein:

the first stem component further includes an annular attachment element disposed at the distal end of the first stent component;

the second stent component further includes an annular attachment element disposed at the distal end of the second stent component; and

the annular attachment element of the first stent component engages the annular attachment element of the second stent component when the first and second stent components are implanted relative to the native heart valve.

20. The valve prosthesis of claim 19, wherein the second stent component further includes at least one strut extending in the distal direction away from the annular attachment element of the second stent component.

21. The valve prosthesis of claim 20, wherein the second stent component further includes at least one eyelet disposed at a distal end of the at least one strut and configured to be grasped by a retrieval catheter.

22. The valve prosthesis of claim 18, wherein the first stent component is self-expanding and includes a collapsed mode when the first stent component is being delivered to an implantation site adjacent the native heart valve and an expanded mode when the first stent component is implanted relative to the native heart valve.

23. The valve prosthesis of claim 18, wherein the second stent component is self-expanding and includes a collapsed mode when the second stent component is being delivered to an implantation site adjacent the native heart valve and an expanded mode when the second stent component is implanted relative to the native heart valve.

24. The valve prosthesis of claim 18, wherein the first stent component includes at least one support strut disposed at the proximal end of the first stent component that is positionable within a respective pocket of the native heart valve when the first stent component is implanted relative to the native heart valve.

25. The valve prosthesis of claim 24, wherein the at least one support strut of the first stent component is curved convexly in a proximal direction of the first stent component.

26. The valve prosthesis of claim 18, wherein the first stent component includes three support struts disposed at the proximal end of the first stent component, each respectively positionable within one of three pockets of the native heart valve, the native heart valve being an aortic valve, when the first stent component is implanted relative to the native heart valve.

27. The valve prosthesis of claim 26, wherein the three support struts are substantially equally spaced from one another.

28. A valve prosthesis, comprising:

a first stem component including (i) a first portion disposed at a proximal end of the first stent component that is positionable radially outward from at least a portion of a native leaflet of a native heart valve and radially inward of a vessel wall adjacent the native heart valve when the first stent component is implanted relative to the native heart valve, and (ii) a second portion disposed at a distal end of the first stent component, opposite the proximal end, wherein the distal end of the first stent component is positioned farther away from a native heart than the proximal end of the first stent component when the first stent component is implanted relative to the native heart valve;

a single set of exactly three substantially equally spaced support struts disposed at the proximal end of the first stent component, each of the three support struts being curved convexly in a proximal direction of the first stent component and respectively positioned within one of three pockets of the native heart valve, the native heart valve being an aortic valve, when the first stent component is implanted relative to the native heart valve;

a second stent component including (i) a first portion disposed at a proximal end of the second stent component that is positionable radially inward of at least a portion of the native leaflet adjacent the first portion of the first stent component when the stent is implanted relative to the native valve, and (ii) a second portion disposed at a distal end of the second stent component, opposite the proximal end, wherein the distal end of the second stent component is positioned farther away from the native heart than the proximal end of the second stent component when the second stent component is implanted relative to the native heart valve; and

a prosthetic valve component attached to the second stent component at the proximal end of the second stent component;

wherein the first portion of the first stent component and the first portion of the second stent component are configured to clamp at least a portion of the native leaflet.