Device for the implantation and fixation of prosthetic valves

• US 9,855,142 B2
• Filed: 06/28/2016
• Issued: 01/02/2018
• Est. Priority Date: 10/28/2005
• Status: Active Grant

• 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:
  US15/195,625
• Publication Number:
  US 20160374803A1
• Time in Patent Office: 553 Days
• 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 self-expandable outer stent component including exactly three struts configured for placement between each of three respective portions of a native aortic valve and an aorta wall upon implantation of the valve prosthesis relative to the native aortic valve, wherein the exactly three struts extend in a proximal direction toward a native heart when the valve prosthesis is implanted relative to the native aortic valve;

a self-expandable inner stent component coupled to the outer stent component via a plurality of engaging elements such that at least a portion of the inner stent component is radially inward of the exactly three struts, the valve prosthesis being configured to receive the three portions of the native aortic valve between the respective three struts and the inner stent component upon implantation of the valve prosthesis relative to the native aortic valve; and

a prosthetic valve component coupled to the inner stent component.

2. The valve prosthesis of claim 1, wherein the plurality of engaging elements join an end portion of the inner stent component to an end portion of the outer stent component.

3. The valve prosthesis of claim 1, wherein the outer stent component includes a docking segment that includes the plurality of engaging elements.

4. The valve prosthesis of claim 3, wherein the inner stent component includes a plurality of retaining elements, each retaining element being complementary to one of the engaging elements of the plurality of engaging elements of the outer stent component.

5. The valve prosthesis of claim 1, wherein the outer stent component is self-expandable independently of self-expansion of the inner stent component.

6. The valve prosthesis of claim 1, wherein each strut of the exactly three struts includes an apex pointing in the proximal direction.

7. The valve prosthesis of claim 1, wherein the exactly three struts are curved arcuately in the proximal direction.

8. The valve prosthesis of claim 1, wherein the valve prosthesis is configured for implantation via a femoral artery.

9. The valve prosthesis of claim 1, wherein the inner stent component is configured such that the inner stent component does not assume a fully expanded state until the inner stent component is guided into a predefined position relative to the outer stent component during implantation relative to the native aortic valve.

10. The valve prosthesis of claim 1, wherein the outer stent component comprises Nitinol.

11. A valve prosthesis, comprising:

a self-expandable outer stent component including a plurality of engaging elements and exactly three struts, wherein the exactly three struts are configured for placement between each of three respective portions of a native aortic valve and an aorta wall upon implantation of the valve prosthesis relative to the native aortic valve, and wherein the exactly three struts extend in a proximal direction toward a native heart when the valve prosthesis is implanted relative to the native aortic valve;

a self-expandable inner stent component comprising a plurality of retaining elements, each retaining element being complementary to one of the engaging elements of the inner stent component to join the inner stent component to the outer stent component, such that at least a portion of the inner stent component is radially inward of the exactly three struts, the valve prosthesis being configured to receive the three portions of the native aortic valve between the respective three struts and the inner stent component upon implantation of the valve prosthesis relative to the native aortic valve; and

a prosthetic valve component coupled to the inner stent component.

12. The valve prosthesis of claim 11, wherein the outer stent component is self-expandable independently of self-expansion of the inner stent component.

13. The valve prosthesis of claim 11, wherein the plurality of engaging elements are joined to the plurality of retaining elements, such that the inner stent component is coupled to the outer stent component, and wherein the plurality of engaging elements are detachable from the plurality of retaining elements.

14. The valve prosthesis of claim 11, wherein the valve prosthesis is configured to clamp the portions of the native aortic valve between the inner stent component and the outer stent component to anchor the valve prosthesis relative to the native aortic valve.

15. The valve prosthesis of claim 11, wherein the exactly three struts are curved convexly in the proximal direction.

16. A valve prosthesis, comprising:

a self-expandable outer stent component including a plurality of engaging elements and exactly three struts, wherein the exactly three struts are configured for placement between each of three respective portions of a native aortic valve and an aorta wall upon implantation of the valve prosthesis relative to the native aortic valve, and wherein the exactly three struts extend in a proximal direction toward a native heart when the valve prosthesis is implanted relative to the native aortic valve;

a self-expandable inner stent component coupled to the outer stent component via the plurality of engaging elements such that at least a portion of the inner stent component is radially inward of the exactly three struts, the valve prosthesis being configured to receive the three portions of the native aortic valve between the respective three struts and the inner stent component upon implantation of the valve prosthesis relative to the native aortic valve; and

a prosthetic valve component coupled to the inner stent component.

17. The valve prosthesis of claim 16, wherein the plurality of engaging elements join an end portion of the inner stent component to an end portion of the outer stent component when the inner stent component and the outer stent component are coupled together.

18. The valve prosthesis of claim 16, wherein the inner stent component is detachably coupled to the outer stent component at a distal end of the outer stent component configured to be positioned farther from the native heart than a proximal end of the outer stent component.

19. The valve prosthesis of claim 16, wherein the inner stent component is self-expandable independently of self-expansion of the outer stent component, such that the inner stent component does not assume a fully expanded state until the inner stent component is guided into a predefined position relative to the outer stent component during implantation relative to the native aortic valve.

20. The valve prosthesis of claim 16, wherein the inner stent component includes a plurality of attachment elements for attachment to a catheter.