Prosthetic valve for transluminal delivery

• US 7,892,281 B2
• Filed: 01/05/2009
• Issued: 02/22/2011
• Est. Priority Date: 11/17/1999
• Status: Expired due to Fees

• Current Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Original Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Inventors: Seguin, Jacques, Börtlein, Georg
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US12/348,892
• Publication Number:
  US 20090164006A1
• Time in Patent Office: 778 Days
• Field of Search: 623 21- 224
• US Class Current: 623/2.1
• 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;

a valve support comprising a generally cylindrical band comprising a plurality of expandable cells, 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 one or more hooks extending radially outward from the valve support.

2. The valve assembly of claim 1, wherein the valve support comprises nickel titanium.

3. 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 comprising a plurality of expandable cells and having the base and the commissures of the valve positioned and secured at or adjacent the expandable cells, the valve support further comprising an anchor;

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

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

deploying the valve assembly within the deficient native valve, whereby the valve support expands against the leaflets of the deficient native valve; and

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

4. The method of claim 3, further comprising the step of positioning the valve support and anchor within a generally tubular sheath extending around the distal portion of the catheter.

5. The method of claim 3, wherein the anchor is self-expanding.

6. The method of claim 3, wherein the valve support is self-expanding.

7. The method of claim 3, wherein the valve support is balloon-expandable.

8. The method of claim 3, further comprising the step of securing a portion of the valve support to the catheter.

9. The method of claim 3, wherein deploying the valve assembly comprises the step of crushing the native valve leaflets against the native valve annulus.

10. The method of claim 3, 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.

11. The method of claim 10, wherein the anchor is spaced from the valve support.

12. 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;

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, and wherein the longitudinal bars of the valve support further comprise a plurality of holes, wherein the plurality of leaflets are secured to the longitudinal bars via suture lines passing through the plurality of holes.

13. The valve assembly of claim 12, wherein the valve support is self-expanding.

14. The valve assembly of claim 12, wherein the valve support is balloon expandable.

15. The valve assembly of claim 12, 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.