Devices, systems, and methods for retaining a native heart valve leaflet

• US 20060069430A9
• Filed: 10/01/2003
• Published: 03/30/2006
• 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 7,527,646 B2
• Time in Patent Office: Days
• US Class Current: 623/2.360
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses

Abstract

Devices, systems and methods retain a native heart valve leaflet to prevent retrograde flow. The devices, systems, and methods employ an implant that, in use, rests adjacent a valve annulus and includes a retaining structure that is sized and shaped to overlay at least a portion of one or more native valve leaflets. The retaining structure retains the leaflet or leaflets it overlays, to resist leaflet eversion and/or prolapse. In this way, the implant prevents or reduces regurgitation. The implant does not interfere significantly with the opening of and blood flow through the leaflets during periods of antegrade flow.

Claims

1. An implant that retains a native heart valve leaflet to resist retrograde flow 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 and including a retaining structure near or within the pseudo-annulus that is sized and shaped to overlay at least a portion of one or more native valve leaflets, the scaffold further including spaced-apart struts sized and configured to contact tissue near or within the heart valve annulus to brace the retaining structure to resist leaflet eversion and/or prolapse.

2. An implant according to claim 1

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

5. An implant according to claim 1

wherein the scaffold is collapsible for placement within a catheter.

6. 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.

7. 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.

8. An implant according to claim 1

wherein the scaffold includes a material and a shape to provide a spring-like bias to enable compliant contact with tissue near or within the heart valve annulus.

9. An implant according to claim 1

wherein the struts reshape the heart valve annulus.

10. An implant according to claim 1

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

11. An implant according to claim 1

wherein the struts displace tissue to reshape the heart valve annulus.

12. An implant according to claim 1

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

13. An implant according to claim 12

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

14. An implant according to claim 12

wherein the second heart valve treatment element includes means for separating tissue along an axis of the heart valve annulus for leafleted coaptation.

15. A method for retaining a native heart leaflet to resist retrograde flow comprising the steps of

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

resisting leaflet eversion and/or prolapse 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 retaining structure as defined in claim 1 overlaying at least a portion of one or more native valve leaflets and with the spaced-apart struts as defined in claim 1 contacting tissue near or within the heart valve annulus to brace the retaining structure.

16. A method according to claim 15

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

17. A method according to claim 15

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

18. A method according to claim 15

wherein the introducing step comprises using an intravascular surgical procedure.