Implantable prosthetic valve with non-laminar flow

• US 8,080,054 B2
• Filed: 07/11/2008
• Issued: 12/20/2011
• Est. Priority Date: 10/02/2003
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton J.
• Primary Examiner(s): PELLEGRINO, BRIAN E
• Application Number:
  US12/171,588
• Publication Number:
  US 20080275549A1
• Time in Patent Office: 1,257 Days
• Field of Search: 623/1.24, 623/1.26, 623 211- 219, 623/902, 623/904
• US Class Current: 623/1.26
• 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 adapted to be initially crimped in a narrow configuration for catheterization through the body duct to a target location and adapted to be deployed 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 providing collapsible slack portions of the conduit at the outlet. 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. 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.

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 at a stent distal end and having an inlet diameter, an outlet portion at a stent proximal end and having an outlet diameter, and a middle portion having a middle diameter, wherein the valve assembly comprises a conduit formed of pliable material, the conduit comprising a conduit inlet end having a conduit inlet end diameter, the conduit further comprising a conduit outlet end having a conduit outlet end diameter, wherein the conduit is positioned within the support stent with the conduit outlet end distal of the conduit inlet end;

advancing the prosthetic valve to the native heart valve; and

radially expanding the support stent in the native heart valve to thereby deploy the prosthetic valve at the native heart valve, wherein radially expanding the support stent comprising radially expanding the support stent such that the middle diameter is greater than the outlet diameter, and the middle diameter is greater than the inlet diameter, wherein the radially expanded stent supports the conduit to have an open configuration wherein fluid flow is permitted distally through the valve assembly and to have a closed configuration wherein fluid flow is blocked through the valve assembly, and when the conduit is in the open configuration the conduit outlet end is positioned radially inwardly from the interior surface of the support stent by a radial distance from 0.5 to 3 cm;

wherein the valve assembly comprises collapsible slack leaflet portions, wherein the conduit of the valve assembly is secured to the support stent via a connecting membrane 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.

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, wherein 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 is positioned in the support stent with the conduit outlet end proximal of the stent distal end and with the conduit inlet end distal of the stent proximal end.

8. 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 first end portion is a distal end portion and the second end portion is a proximal end portion, wherein the valve assembly comprises a conduit formed from pliable material, the conduit comprising a conduit inlet end and a conduit outlet end, wherein the conduit is positioned within the middle portion of the support stent with the conduit outlet end distal of the conduit inlet end and with the conduit outlet end proximal of the support stent distal end portion;

advancing the prosthetic valve to the desired target location in the patient'"'"'s heart; and

radially expanding the support stent to thereby implant the prosthetic valve at the desired target location, wherein the support stent is expanded such that the middle diameter is greater than the second end diameter and the first end diameter, wherein the stent is expanded to support the conduit to have an open configuration wherein fluid flow is permitted distally through the valve assembly and to have a closed configuration wherein fluid flow is blocked through the valve assembly, wherein the support stent is expanded such that the conduit in the open configuration at the conduit outlet end is positioned radially inwardly from the interior surface of the support stent by a radial distance from 0.5 to 3 cm;

wherein the valve assembly comprises collapsible slack leaflet portions, wherein the conduit of the valve assembly is secured to the support stent via a connecting membrane 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.

9. The method of claim 8, wherein deploying the prosthetic valve comprises applying a substantially radial force from within the prosthetic valve.

10. The method of claim 9, wherein the substantially radial force is provided by means of the delivery catheter.

11. The method of claim 8, wherein the delivery catheter comprises a balloon catheter.

12. The method of claim 8, wherein the native valve position is an aortic valve position.

13. The method of claim 12, wherein advancing the prosthetic valve toward the target location comprises advancing the prosthetic valve in a retrograde fashion through the aorta.

14. The method of claim 12, 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.

15. The method of claim 8, wherein deploying the prosthetic valve comprises expanding the prosthetic valve to a diameter between about 19 mm and about 26 mm.

16. The method of claim 8, wherein the prosthetic valve comprises generally elongated support beams.