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

• US 20080065204A1
• Filed: 10/31/2007
• Published: 03/13/2008
• Est. Priority Date: 09/20/2000
• Status: Active Grant

• Current Assignee: MVRx, Inc.
• Original Assignee: Ample Medical, Inc. (MVRx, Inc.)
• Inventors: Chang, Robert, Soss, Rick, Rahdert, David, Macoviak, John, Machold, Timothy
• Granted Patent: US 8,016,882 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• 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

An implant for supplementing, repairing, or replacing a native heart valve leaflet or leaflets provides a scaffold, which defines a pseudo-annulus. The implant further has at least two struts in generally oppositely spaced apart positions on the scaffold. The scaffold can be placed in an elastically loaded condition in a heart with the struts engaging tissue at or near the leaflet commissures of a heart valve annulus, to reshape the annulus for leaflet coaptation. The implant further provides a neoleaflet element coupled to the scaffold within pseudo-annulus, to provide a one-way valve function.

Claims

1. A method for supplementing, repairing, or replacing a native heart valve leaflet or leaflets comprising

providing an implant comprising a scaffold, at least a portion of the scaffold defining a pseudo-annulus, the scaffold comprising a normal, unloaded condition and an elastically loaded condition, the implant further comprising at least two struts in generally oppositely spaced apart positions, the implant further comprising a neoleaflet element coupled to the Scaffold within pseudo-annulus to provide a one-way valve function,

introducing the implant into a heart,

applying external compression forces to place the elastic scaffold into the elastically loaded condition,

while the elastic scaffold is in the elastically loaded condition, placing the struts into engagement with tissue at or near the leaflet commissures to reshape the annulus for leaflet coaptation, and

providing a one-way valve function with the neoleaflet element.

2. A method according to claim 1

wherein the introducing comprises using an open heart surgical procedure.

3. A method according to claim 1

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

4. A method according to claim 1

wherein the introducing comprises using an intravascular surgical procedure.

5. An implant for supplementing, repairing, or replacing a native heart valve leaflet or leaflets comprising

a scaffold, at least a portion of the scaffold defining a pseudo-annulus, the scaffold comprising a normal, unloaded condition and an elastically loaded condition, the implant further comprising at least two struts in generally oppositely spaced apart positions, the implant further comprising a neoleaflet element coupled to the scaffold within pseudo-annulus to provide a one-way valve function, the scaffold being sized and configured to be introduced into a heart and placed into the elastically loaded condition by application of external compression forces while placing the struts into engagement with tissue at or near the leaflet commissures to reshape the annulus for leaflet coaptation and also providing a one-way valve function with the neoleaflet element.

6. An implant according to claim 5

wherein the scaffold is sized and configured to be introduced into a heart in an open heart surgical procedure.

7. An implant according to claim 5

wherein the scaffold is sized and configured to be introduced into a heart carried within a catheter.

8. An implant according to claim 5

wherein the scaffold is sized and configured to be introduced into a heart in an intravascular surgical procedure.

9. An implant for supplementing, repairing, or replacing a native heart valve leaflet or leaflets comprising

an elastic scaffold, at least a portion of the elastic scaffold defining a pseudo-annulus, the elastic scaffold comprising a normal, unloaded condition including a spring constant to undergo compression in response to applied external compression forces into an elastically loaded condition, the implant further comprising at least two struts coupled to the elastic scaffold in generally oppositely spaced apart positions defining, when the elastic scaffold is in the normal, unloaded condition, a normal cross-strut distance that is greater than the maximum cross-annulus distance, the implant further comprising a neoleaflet element coupled to the elastic 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, the scaffold being sized and configured to be introduced into a heart with the elastic scaffold in the normal, unloaded condition and placed into the elastically loaded condition by application of external compression forces at the at least two struts to reduce the normal cross-strut distance while placing the struts into engagement with tissue at or near the leaflet commissures to apply tension and outwardly displace and separate tissue along the major axis of the annulus to reshape the annulus for leaflet coaptation to provide a one-way valve function with the neoleaflet element that, in response to a first pressure condition, assumes the valve opened condition and, in response to second pressure condition, assumes the valve closed condition, the at least two struts tissue at or near the leaflet commissures bracing the elastic scaffold while in the elastically loaded condition against migration within the annulus during the one-way valve function.

10. An implant according to claim 9

wherein the scaffold is sized and configured to be introduced into a heart in an open heart surgical procedure.

11. An implant according to claim 9

wherein the scaffold is sized and configured to be introduced into a heart carried within a catheter.

12. An implant according to claim 9

wherein the scaffold is sized and configured to be introduced into a heart in an intravascular surgical procedure.

13. A system comprising

a catheter sized and configured to be introduced into a heart in an intravascular surgical procedure,

an implant carried within the catheter, the implant comprising a scaffold, at least a portion of the scaffold defining a pseudo-annulus, the scaffold comprising a normal, unloaded condition and an elastically loaded condition, the implant further comprising at least two struts in generally oppositely spaced apart positions, the implant further comprising a neoleaflet element coupled to the scaffold within pseudo-annulus to provide a one-way valve function, the scaffold being sized and configured to be introduced into a heart and placed into the elastically loaded condition by application of external compression forces while placing the struts into engagement with tissue at or near the leaflet commissures to reshape the annulus for leaflet coaptation and also providing a one-way valve function with the neoleaflet element, and

the catheter including a mechanism to place the struts into engagement with tissue at or near the leaflet commissures to reshape the annulus for leaflet coaptation.

14. A heart valve structure comprising

a scaffold defining a pseudo-annulus, the scaffold resting an elastically loaded condition within an annulus and including struts engaging tissue at or near valve leaflet commissures to reshape the annulus for leaflet coaptation, the scaffold also including a neoleaflet element within the pseudo-annulus to provide a one-way valve function.