PROSTHETIC VALVE FOR TRANSLUMINAL DELIVERY

• US 20080133003A1
• Filed: 02/11/2008
• Published: 06/05/2008
• Est. Priority Date: 11/17/1999
• Status: Active Grant

• Current Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Inventors: Seguin, Jacques, Bortlein, Georg
• Granted Patent: US 10,219,901 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: Y10S 623/904 Heart

Abstract

A prosthetic valve assembly for use in replacing a deficient native valve comprises a replacement valve supported on an expandable valve support. If desired, one or more anchor may be used. The valve support, which entirely supports the valve annulus, valve leaflets, and valve commissure points, is configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned. The anchor engages the lumen wall when expanded and prevents substantial migration of the valve assembly when positioned in place. The prosthetic valve assembly is compressible about a catheter, and restrained from expanding by an outer sheath. The catheter may be inserted inside a lumen within the body, such as the femoral artery, and delivered to a desired location, such as the heart. When the outer sheath is retracted, the prosthetic valve assembly expands to an expanded position such that the valve and valve support expand within the deficient native valve, and the anchor engages the lumen wall.

Claims

1. A prosthetic valve assembly for use in replacing a deficient native valve, the valve assembly comprising:

a valve having a plurality of resilient leaflets;

a valve support configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is properly positioned, said valve support supporting the base and the commissure points of the valve; and

an anchor for engaging the lumen wall when expanded in place for preventing substantial migration of the valve assembly after deployment.

2. The valve assembly of claim 1, wherein the leaflets are made of natural tissue.

3. The valve assembly of claim 1, wherein the leaflets are made of synthetic material.

4. The valve assembly of claim 1, wherein the valve support and anchor are self-expanding.

5. The valve assembly of claim 4, wherein the configuration and radial force of the valve support substantially preclude any portion of the native valve that remains from obstructing effective placement of said assembly.

6. The valve assembly of claim 1, wherein the valve support comprises a single length of wire.

7. The valve assembly of claim 1, wherein the anchor is configured to exert sufficient radial forces against the lumen wall to prevent substantial migration.

8. The valve assembly of claim 1 further comprising a second anchor.

9. The valve assembly of claim 1 wherein the anchor is flared to conform to the local anatomy.

10. The valve assembly of claim 1 further comprising a delivery catheter having a distally positioned sheath to house the valve assembly in a collapsed position for transluminal delivery and deployment of the valve assembly where desired.

11. The valve assembly of claim 10, further comprises at least one hook for engaging a portion of the valve support for controlled release of said support.

12. The valve assembly of claim 1 wherein the anchor is spaced from the valve support.

13. A method of replacing a deficient native valve comprising the steps of:

providing a prosthetic valve assembly, the assembly comprising a valve, a valve support permitting attachment thereto of the base and the commissures of the valve, and an anchor for engaging the lumen wall when expanded for preventing substantial migration of the valve assembly when positioned in place;

collapsing the valve support and anchor to fit within a distally positioned sheath on a catheter;

advancing the catheter to the deficient native valve;

deploying the valve assembly; and

withdrawing the catheter, leaving the valve assembly to function in place of the deficient native valve.

14. The method of claim 13, wherein the valve support and anchor are self-expanding.

15. The method of claim 13 further comprising the step of hooking a portion of the valve support to the catheter.

16. The method of claim 13, further comprising the step of excising the native valve.

17. The method of claim 13, wherein the excising step comprises using the same catheter used to deploy the valve assembly.

18. The method of claim 13, wherein the anchor is spaced from the valve support.