Method of implanting a prosthetic aortic valve having non-laminar flow

• US 9,241,793 B2
• Filed: 12/19/2011
• Issued: 01/26/2016
• 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:
  US13/330,370
• Publication Number:
  US 20120158118A1
• Time in Patent Office: 1,499 Days
• Field of Search: 623/1.24, 623/1.26, 623/1.3, 623/1.31, 623/1.35, 623 211- 219, 623/2.38, 623/2.4, 623/2.41
• US Class Current: 1/1
• 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 and methods for deployment is disclose. The device comprises an expandable support stent 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. Flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, but reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly. 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 aortic valve in a patient'"'"'s body, comprising:

providing a delivery catheter and prosthetic valve, the delivery catheter having the prosthetic valve mounted thereon, the prosthetic valve comprising a leaflet-valve assembly and a support frame, wherein the support frame comprises an annular, net-like support stent forming a stent lumen, the stent adapted to be radially crimped into a narrow delivery configuration and subsequently radially expanded to an expanded implantation configuration, the stent comprising a stent inlet end and a stent outlet end, wherein the leaflet-valve assembly comprises a conduit having a conduit inlet end and a conduit outlet end, the conduit formed of pliant material arranged so as to present three leaflets at the conduit outlet end in a tricuspid configuration for permitting flow from the conduit inlet end to the conduit outlet end while blocking reverse flow, wherein the leaflet-valve assembly is positioned within the stent lumen with the conduit inlet end positioned at the stent proximal end and the leaflets positioned proximal to the stent outlet end, wherein the valve assembly is sewn to the support stent with the conduit inlet end securely fastened to the stent inlet end to direct any flow thereinto;

advancing the prosthetic valve into the patient'"'"'s body via a body lumen;

positioning the prosthetic valve at a natural aortic valve location;

radially expanding the stent to thereby implant the prosthetic valve at the natural aortic valve location, wherein expanding the stent comprises expanding the stent inlet end to a stent inlet end deployed diameter, wherein expanding the stent further comprises expanding the stent outlet end to a stent outlet end deployed diameter, and wherein the stent inlet end deployed diameter is larger than the stent outlet end deployed diameter.

2. The method of claim 1, wherein radially expanding the stent comprises expanding the stent to support the leaflet-valve assembly to form a tapered shape from the conduit inlet end to the conduit outlet end.

3. The method of claim 2, wherein the delivery catheter is a balloon catheter having a radially expandable balloon, and radially expanding the stent comprises radially expanding the balloon.

4. The method of claim 1, wherein the support stent is made from a nickel-titanium shape memory alloy.

5. The method of claim 1, wherein the three leaflets are made from pericardial tissue.

6. The method of claim 1, wherein a inlet end of the leaflet-valve assembly is rolled over the inlet end of the annular support stent.

7. The method of claim 1, wherein the support frame comprises a plurality of support beams.

8. The method of claim 7, wherein each of the support beams comprises bores to which the conduit is stitched.

9. The method of claim 1, wherein radial sections of the leaflet-valve assembly are closed to narrow an outlet end thereof while leaving the collapsible walls of the conduit free.

10. The method of claim 1, wherein the stent inlet end deployed diameter being larger than the stent distal portion deployed diameter creates a non-laminar retrograde flow that assists in the closing of the collapsible walls at the conduit outlet end.

12. The method of claim 1, wherein advancing the prosthetic valve into the patient'"'"'s body via the body lumen comprises approaching the aortic valve from the descending aorta.

13. The method of claim 1, wherein advancing the prosthetic valve into the patient'"'"'s body via the body lumen comprises approaching the aortic valve from the left ventricle.

11. A method for implanting a prosthetic aortic valve in a in a patient'"'"'s body, comprising:

providing a delivery catheter and prosthetic valve, the delivery catheter having the prosthetic valve mounted thereon, the prosthetic valve comprising a leaflet-valve assembly and a support frame, wherein the support frame comprises an annular, net-like, support stent forming a stent lumen, the support stent adapted to be radially crimped into a narrow delivery configuration and subsequently radially expanded to an expanded implantation configuration, the support stent comprising a stent inlet end and a stent outlet end, the support stent made from a nickel-titanium shape memory alloy, wherein the leaflet-valve assembly comprises a conduit having a conduit inlet end and a conduit outlet end, the conduit comprising three leaflets made from pericardial tissue arranged so as to present collapsible walls at the conduit outlet end in a tricuspid configuration for permitting flow from the conduit inlet end to the conduit outlet end while blocking reverse flow, wherein the leaflet-valve assembly is positioned within the stent lumen with the conduit inlet end positioned at the stent inlet end and the leaflets positioned proximal to the stent outlet end, wherein the valve assembly is sewn to the support stent with the conduit inlet end securely fastened to the stent inlet end;

advancing the prosthetic valve into the patient'"'"'s body via a body lumen;

positioning the prosthetic valve at a natural aortic valve location;

radially expanding the support stent to thereby implant the prosthetic valve at the natural aortic valve location, wherein expanding the support stent comprises expanding the stent inlet end to a stent inlet end deployed diameter, wherein expanding the stent further comprises expanding the stent outlet end to a stent outlet end deployed diameter, and wherein the stent inlet end deployed diameter is larger than the stent outlet end deployed diameter, the expanded support stent supporting the leaflet-valve assembly to form a tapered shape from the conduit inlet end to the conduit outlet end.

14. The method of claim 11, wherein advancing the prosthetic valve into the patient'"'"'s body via the body lumen comprises approaching the aortic valve from the descending aorta.

15. The method of claim 11, wherein advancing the prosthetic valve into the patient'"'"'s body via the body lumen comprises approaching the aortic valve from the left ventricle.