Implantable prosthetic valve with non-laminar flow

• US 10,154,900 B2
• Filed: 01/08/2016
• Issued: 12/18/2018
• 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:
  US14/991,852
• Publication Number:
  US 20160120644A1
• Time in Patent Office: 1,075 Days
• 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 disclosed. 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 valve prosthesis device suitable for cardiac implantation in corporeal ducts, the device comprising:

a support stent comprising an inlet portion and an outlet portion narrower than the inlet portion, wherein the support stent comprises an annular frame adapted to be crimped in a first narrow configuration and be radially deployable so as to extend to a second expanded configuration to occupy a passage at the target location for implantation in the corporeal duct,

a valve assembly comprising a flexible conduit formed from pliant material formed into leaflets and having an inlet and an outlet, wherein the flexible conduit provides collapsible slack portions arranged to open to permit fluid flow from the inlet to the outlet and to collapse to prevent fluid flow from the outlet to the inlet,

and a connection structure that supports the valve assembly in the support stent such that the inlet of the valve assembly is spaced radially inwardly of the support stent and forms an annular space between an inner surface of the support stent and the valve assembly at the inlet of the valve assembly when the support stent is in the second expanded configuration;

wherein the annular space is defined between the inner surface of the support stent and an outer surface of the valve assembly along a radius of the prosthesis device extending through the inner surface of the support stent and the outer surface of the valve assembly at the inlet of the valve assembly;

wherein 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; and

wherein a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow, wherein the annular space extends from the inlet to the outlet of the valve assembly.

2. The valve prosthesis of claim 1, wherein the support stent comprises 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 means of a deployment device to a deployed state in the target location.

3. The valve prosthesis of claim 1, wherein the device is configured so that an artificial sinus is formed adjacent to the valve assembly.

4. The valve prosthesis of claim 1, wherein the support stent is provided with a plurality of longitudinally rigid support beams of fixed length.

5. The valve prosthesis of claim 4, wherein the valve assembly is attached to the support beams via the connection structure.

6. The valve prosthesis device of claim 1, wherein said valve assembly has a tricuspid configuration.

7. The valve prosthesis device of claim 1, wherein the valve assembly is made from pericardial tissue, or other biological tissue.

8. The valve prosthesis device of claim 1, wherein when the valve assembly leaflets are in the collapsed state substantial portions of the leaflets fall on each other creating better sealing.

9. The valve prosthesis device of claim 1, wherein the support stent is provided with heavy metal markers so as to enable tracking and determining the valve device position and orientation.

10. The valve prosthetic device of claim 1, wherein the support stent is 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.

11. The valve prosthetic device of claim 1, wherein the support stent at the outlet is wider in diameter than the pliant material forming the conduit.

12. The valve prosthetic device of claim 1, wherein the device is configured to be deployed with an expandable balloon.

13. The valve prosthetic device of claim 1, wherein the support stent when deployed has a diameter in the range of about 19 mm to about 26 mm.

14. The valve prosthetic device of claim 1, wherein the support stent is made from nickel titanium.

15. The valve prosthetic device of claim 1, wherein the support stent comprises hooks to secure the device in position after implantation.

16. The prosthetic heart valve of claim 1, wherein the valve assembly has a cross-sectional area from about 40% to 80% of a cross-sectional area of the support stent across a midsection of the support stent.

17. A prosthetic heart valve, comprising:

a support stent comprising an inlet end and an outlet end, the support stent tapering from a first diameter at the inlet end to a second, smaller diameter at the outlet end, wherein the support stent comprises an annular frame adapted to be crimped in a first narrow configuration and be radially deployable so as to extend to a second expanded configuration to occupy a passage at the target location for implantation in the corporeal duct; and

a valve assembly comprising a flexible conduit formed from pliant material formed into leaflets and having an inlet and an outlet, wherein the flexible conduit provides collapsible slack portions arranged to open to permit fluid flow from the inlet to the outlet and to collapse to prevent fluid flow from the outlet to the inlet;

a connection structure that supports the valve assembly in the support stent such that the valve assembly is spaced radially inwardly of an inner surface of the support stent at the inlet of the valve assembly so as to define an annular space between the inlet of the valve assembly and the support stent when the support stent is in the second expanded configuration;

wherein the annular space is defined between the inner surface of the support stent and an outer surface of the valve assembly along a radius of the prosthesis device extending through the inner surface of the support stent and the outer surface of the valve assembly at the inlet of the valve assembly;

wherein 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; and

wherein a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow, wherein the annular space extends from the inlet to the outlet of the valve assembly.

18. The prosthetic heart valve of claim 17, wherein the support stent further comprises hooks to secure the prosthetic heart valve in place after implantation.

19. The prosthetic heart valve of claim 17, wherein there are three leaflets and each leaflet comprises opposing sides with each side being paired with an adjacent side of an adjacent leaflet to form three pairs of adjacent sides, wherein each pair of adjacent sides is spaced radially inwardly of the inner surface of the support stent.