Prosthetic Valve For Transluminal Delivery

• US 20110125257A1
• Filed: 01/20/2011
• Published: 05/26/2011
• Est. Priority Date: 11/17/1999
• Status: Active Grant

• Current Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Original Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Inventors: SEGUIN, Jacques, Börtlein, Georg
• Granted Patent: US 9,066,799 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• 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 leaflets, a base, and a plurality of commissure points; and

a valve support comprising a generally cylindrical band of expandable cells, the valve support configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of a native valve when the assembly is positioned in situ, wherein the generally cylindrical band of the valve support supports the base and the commissure points of the valve.

2. The valve assembly of claim 1, wherein one or more of the commissure points of the valve are positioned and secured at or adjacent one of the expandable cells.

3. The valve assembly of claim 1, further comprising;

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

wherein the anchor is itself configured to be expandable, and wherein at least part of the anchor is positioned away from the generally cylindrical band of the valve support.

4. The valve assembly of claim 3, wherein the anchor has an expanded diameter that is different from the expanded diameter of the valve support.

5. The valve assembly of claim 1, further comprising;

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

wherein the anchor comprises one or more hooks extending radially outward from the valve support.

6. The valve assembly of claim 5, wherein the valve support comprises nickel titanium.

7. The valve assembly of claim 1, wherein the valve support has a longitudinal axis, wherein the valve includes a distal end opposite the valve base and the distal end of the valve is located on a first plane perpendicular to the longitudinal axis of the valve support, and wherein a portion of one or more of the expandable cells is positioned between the commissure points on the first plane.

8. The valve assembly of claim 1, wherein the valve support has a longitudinal axis, wherein the valve includes a distal end opposite the valve base and the distal end of the valve is located on a first plane perpendicular to the longitudinal axis of the valve support, and wherein a plurality of cells are positioned between the commissure points of the valve on the first plane.

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

providing a prosthetic valve assembly, wherein the assembly comprises a valve, a collapsible and expandable valve support comprising a generally cylindrical band of expandable cells, wherein the generally cylindrical band of the valve support supports the base and the commissure points of the valve;

collapsing the valve support to fit on a distal portion of a catheter;

advancing the catheter to a deficient native valve to a position adjacent the leaflets and within the annulus of a deficient native valve;

deploying the valve assembly within a deficient native valve to expand the valve support against the leaflets of a deficient native valve; and

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

10. The method of claim 9, further comprising the step of positioning the valve support within a generally tubular sheath extending around the distal portion of the catheter.

11. The method of claim 9, wherein the valve support is self-expanding.

12. The method of claim 9, wherein the valve support is balloon-expandable.

13. The method of claim 9, further comprising the step of securing a portion of the valve support to the catheter.

14. The method of claim 9, wherein deploying the valve assembly comprises the step of crushing the native valve leaflets against the native valve annulus.

15. The method of claim 9, wherein the prosthetic valve assembly further comprises an anchor for engaging a lumen wall for preventing substantial migration of the valve assembly when positioned in place.

16. The method of claim 15, wherein the anchor is spaced from the valve support.

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

a valve having a base, a plurality of leaflets and commissure points; and

a valve support comprising a plurality of expandable cells and a plurality of longitudinal bars, the valve support configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is positioned in situ, said valve support supporting the base, wherein the commissure points of the valve are secured at the longitudinal bars and adjacent one or more of the expandable cells.

18. The valve assembly of claim 17, wherein the valve support is self-expanding.

19. The valve assembly of claim 17, wherein the valve support is balloon expandable.

20. The valve assembly of claim 17, wherein the valve support is configured to press radially against the native valve leaflets to hold the native valve leaflets against walls of the native valve annulus and/or against walls of an adjacent lumen to thereby prevent the native valve leaflets from obstructing the native valve annulus.

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

a valve having a plurality of leaflets, a base, and a plurality of commissure points;

a valve support comprising a generally cylindrical band comprising a plurality of expandable cells having a first cell size in the unexpanded state, the valve support configured to be collapsible for transluminal delivery and expandable to contact the anatomical annulus of the native valve when the assembly is positioned in situ, said generally cylindrical band of the 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,

wherein the anchor comprises a generally cylindrical band comprising a plurality of expandable cells having a second size in the unexpanded state,

wherein the anchor is configured to be expandable, wherein at least part of the anchor is positioned away from the generally cylindrical band of the valve support, and wherein the second cell size is larger than the first cell size cell.