Devices, systems, and methods for supplementing, repairing, or replacing a native heart valve leaflet

• US 20050267573A9
• Filed: 10/01/2003
• Published: 12/01/2005
• Est. Priority Date: 09/20/2000
• Status: Active Grant

• Current Assignee: MVRx, Inc.
• Original Assignee: Ample Medical, Inc. (MVRx, Inc.)
• Inventors: Machold, Timothy R., Rahdert, David A., Chang, Robert T., Macoviak, John A., Soss, Rick A.
• Granted Patent: US 7,381,220 B2
• Time in Patent Office: Days
• US Class Current: 623/2.360
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses

Abstract

Devices, systems and methods supplement, repair, or replace a native heart valve. The devices, systems, and methods employ an implant that, in use, extends adjacent a valve annulus. The implant includes a mobile neoleaflet element that occupies the space of at least a portion of one native valve leaflet. The implant mimics the one-way valve function of a native leaflet, to resist or prevent retrograde flow. The implant restores normal coaptation of the leaflets to resist retrograde flow, thereby resisting eversion and/or prolapse, which, in turn, reduces regurgitation.

Claims

1. An implant that supplements, repairs, or replaces a native heart valve leaflet or leaflets comprising

a scaffold sized and configured to rest adjacent all or a portion of a native heart valve annulus, at least a portion of the scaffold defining a pseudo-annulus,

a neoleaflet element coupled to the scaffold within pseudo-annulus and being sized and shaped to occupy the space of at least a portion of one native heart valve leaflet to provide a one-way valve function that, in response to a first pressure condition, assumes a valve opened condition within the pseudo-annulus and, in response to a second pressure condition, assumes a valve closed condition within the pseudo-annulus, and

spaced-apart struts appended to the scaffold and being sized and configured to contact tissue near or within the heart valve annulus to brace the scaffold against migration within the annulus during the one-way valve function.

2. An implant according to claim 1

wherein the scaffold comprises a wire-form structure.

3. An implant according to claim 1

wherein at least one of the struts comprises a wire-form structure.

4. An implant according to claim 1

wherein the scaffold and the struts each comprises a wire-form structure.

5. An implant according to claim 1

wherein the neoleaflet element includes a bridge appended to the scaffold.

6. An implant according to claim 5

wherein the neoleaflet element includes a material covering the bridge.

7. An implant according to claim 5

wherein the bridge is a wire-form structure.

8. An implant according to claim 1

wherein the neoleaflet element includes a duckbill valve within the psuedo-annulus.

9. An implant according to claim 1

wherein the neoleaflet element includes a membrane within the pseudo-annulus.

10. An implant according to claim 1

wherein the neoleaflet element is sized and configured to coapt with a native leaflet when in the valve closed condition.

11. An implant according to claim 1

wherein the scaffold, neoleaflet element, and the struts are collapsible for placement within a catheter.

12. An implant according to claim 1

wherein at least one of the struts carries a structure sized and configured to increase a surface area of contact with tissue at, above, or below the annulus.

13. An implant according to claim 1

further including at least one structure appended to the scaffold and being sized and configured to contact tissue at, above, or below the heart valve annulus to stabilize the scaffold.

14. An implant according to claim 1

wherein the scaffold, neoleaflet element, and struts include materials and shapes to provide a spring-like bias for compliance with anatomy near or within the heart valve annulus.

15. An implant according to claim 1

wherein the struts apply tension to tissue.

16. An implant according to claim 1

wherein the struts apply tension to tissue to reshape the heart valve annulus.

17. An implant according to claim 1

wherein the struts apply tension to separate tissue along an axis of the heart valve annulus.

18. An implant according to claim 1

further including a second heart valve treatment element appended to the scaffold to affect a heart valve function.

19. An implant according to claim 18

wherein the second heart valve treatment element includes means for reshaping the heart valve annulus for leaflet coaptation.

20. An implant according to claim 18

wherein the second heart valve treatment element includes means for stretching leaftlet commissures for leaflet coaptation.

21. A method for supplementing, repairing, or replacing a native heart valve leaflet or leaflets comprising the steps of

introducing an implant as defined in claim 1 into a heart, and

providing a one-way valve function that, in response to a first pressure condition, assumes a valve opened condition and, in response to second pressure condition, assumes a valve closed condition by locating the scaffold as defined in claim 1 adjacent all or a portion of a native heart valve annulus to define a pseudo-annulus, with the neoleaflet element as defined in claim 1 occupying the space of at least a portion of one native heart valve leaflet to provide the one-way valve function, and with the spaced-apart struts as defined in claim 1 contacting tissue near or within the heart valve annulus to brace the scaffold against migration within the annulus during the one-way valve function.

22. A method according to claim 21

wherein the introducing step comprises using an open heart surgical procedure.

23. A method according to claim 21

wherein the introducing step comprises using a surgical procedure in which the implant is carried within a catheter.

24. A method according to claim 21

wherein the introducing step comprises using an intravascular surgical procedure.