IMPLANTABLE PROSTHETIC VALVE WITH NON-LAMINAR FLOW

• US 20080275549A1
• Filed: 07/11/2008
• Published: 11/06/2008
• Est. Priority Date: 10/02/2003
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Inventors: Rowe, Stanton J.
• Granted Patent: US 8,080,054 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A valve prosthesis device is disclosed suitable for implantation in body ducts. The device comprises a support stent comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet. The support stent is provided with a plurality of longitudinally rigid support beams of fixed length. When flow is allowed to pass through the valve prosthesis device from the inlet to the outlet the valve assembly is kept in an open position, whereas a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow. The device is configured so that retrograde flow will be altered from laminar flow and directed towards the leaflets to effect closing. The device can be deployed in a native heart valve position using a deployment catheter advanced through a body lumen such as a blood vessel, including an aorta.

Claims

1. A method for implanting a prosthetic valve in a native heart valve, comprising:

providing a delivery catheter and prosthetic valve, the delivery catheter having the prosthetic valve mounted thereon, the prosthetic valve comprising a support stent and a valve assembly, the support stent comprising an inlet portion having an inlet diameter, an outlet portion having an outlet diameter, and a middle portion having a middle diameter, wherein the middle diameter is greater than the outlet diameter, and the middle diameter is greater than the inlet diameter;

advancing the prosthetic valve to the native heart valve; and

deploying the prosthetic valve at the native heart valve.

2. The method of claim 1, wherein advancing the prosthetic valve to the native heart valve comprises advancing the prosthetic valve through a blood vessel.

3. The method of claim 2, wherein the blood vessel is an aorta.

4. The method of claim 1, wherein advancing the prosthetic valve to the native heart valve comprises advancing the prosthetic valve through a ventricle and through a trans-septal puncture.

5. The method of claim 1, deploying the prosthetic valve comprises expanding the prosthetic valve to a diameter between about 19 mm and about 26 mm.

6. The method of claim 1, wherein providing the delivery catheter and prosthetic valve comprises crimping the prosthetic valve onto the delivery catheter.

7. The method of claim 1, wherein the valve assembly comprises collapsible slack leaflet portions, wherein the valve assembly is secured to the support stent such that when the prosthetic valve is deployed the entirety of one or more collapsible slack leaflet portions is held away from the support stent interior surface to form an artificial sinus between the support stent interior surface and the collapsible slack leaflet portions.

8. The method of claim 7, wherein support stent has an inlet end and an outlet end, and wherein the valve assembly is positioned away from the inlet end and away from the outlet end.

9. The method of claim 1, wherein deploying the prosthetic valve comprises expanding the prosthetic valve to a diameter between about 19 mm and about 26 mm.

11. The method of claim 1, wherein deploying the prosthetic valve comprises applying a substantially radial force from within the prosthetic valve.

12. The method of claim 11, wherein the substantially radial force is provided by means of the delivery catheter.

13. The method of claim 1, wherein the delivery catheter comprises a balloon catheter.

14. The method of claims 1, wherein providing the delivery catheter and prosthetic valve comprises crimping the prosthetic valve onto the delivery catheter.

15. The method of claim 1, wherein the target location is a native valve position.

16. The method of claim 15, wherein the native valve position is an aortic valve position.

17. The method of claim 16, wherein advancing the prosthetic valve toward the target location comprises advancing the prosthetic valve in a retrograde fashion through the aorta.

18. The method of claim 16, wherein advancing the prosthetic valve toward the target location comprises advancing the prosthetic valve in an antegrade fashion from the left ventricle and through a trans-septal puncture.

19. The method of claim 1, wherein deploying the prosthetic valve comprises expanding the prosthetic valve to a diameter between about 19 mm and about 26 mm.

20. The method of claim 1, wherein the prosthetic valve comprises generally elongated support beams.

10. A method for implanting a prosthetic valve in a target location in a patient'"'"'s heart, comprising:

providing a delivery catheter and prosthetic valve, the delivery catheter having the prosthetic valve mounted thereon, the prosthetic valve comprising a support stent and a valve assembly, the support stent comprising a first end portion having a first end diameter, a second end portion having a second end diameter, and a middle portion having a middle diameter, wherein the middle diameter is greater than the second end diameter and the first end diameter;

advancing the prosthetic valve to the desired target location; and

deploying the prosthetic valve at the desired target location.