IMPLANTABLE PROSTHETIC VALVE

• US 20120277856A1
• Filed: 06/21/2012
• Published: 11/01/2012
• Est. Priority Date: 10/11/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Inventors: Spenser, Benjamin, Benichu, Netanel, Bash, Assaf, Zakai, Avraham
• Granted Patent: US 8,632,586 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2421 with non-pivoting rigid closure members
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9524 Iris-type crimpers
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

A method of replacing a deficient native aortic valve with a self-expandable prosthetic valve is disclosed. The method involves advancing a self-expandable prosthetic valve through a tapered tube for crimping the prosthetic valve into a crimped diameter. The prosthetic valve is then advanced into a restriction tube for maintaining the prosthetic valve in the crimped diameter. The prosthetic valve is then advanced into a body and is positioned within the deficient native aortic valve. The prosthetic valve is then released from the restriction tube such that the prosthetic valve self-expands to an expanded diameter for anchoring within the deficient native aortic valve. The prosthetic valve comprises an expandable tubular support frame and a valve assembly positioned within the support frame. The valve assembly is formed with pericardial tissue and has three leaflets for providing blockage to a reverse flow of blood.

Claims

1. A method of replacing a deficient native aortic valve with a prosthetic valve, comprising:

advancing a self-expandable prosthetic valve through a tapered tube for crimping the prosthetic valve into a crimped diameter;

advancing the prosthetic valve into a restriction tube for maintaining the self-expandable prosthetic valve in the crimped diameter;

inserting the prosthetic valve into a body and positioning the prosthetic valve within the deficient native aortic valve;

releasing the prosthetic valve from the restriction tube such that the prosthetic valve self-expands to an expanded diameter for anchoring within the deficient native aortic valve;

wherein the self-expandable prosthetic valve comprises an expandable tubular support frame and a valve assembly positioned within the support frame, the valve assembly formed with pericardial tissue and having three leaflets for allowing blood to pass from an inlet to an outlet of the valve assembly and for providing blockage to a reverse flow of blood.

2. The method of claim 1, wherein the support frame is formed of a shape memory material.

3. The method of claim 2, wherein the shape memory material comprises nickel titanium.

4. The method of claim 1, wherein the valve assembly is sutured to the support frame.

5. The method of claim 1, wherein the support frame further comprises longitudinal rigid support beams.

6. The method of claim 5, wherein the valve assembly is sutured to the support frame at the rigid support beams.

7. The method of claim 6, wherein the rigid support beams are provided with a plurality of bores for suturing the valve assembly to the support frame.

8. The method of claim 1, wherein the support frame comprises a web construction capable of being crimped to the crimped diameter and then deployed to the expanded diameter.

9. The method of claim 1, wherein the valve assembly is positioned within the support frame to provide an open wall structure adjacent to the leaflets of the valve assembly, the open wall structure suitable for permitting blood flow therethrough to the coronary arteries.

10. The method of claim 1, wherein the crimped diameter is less than 8 mm.

11. The method of claim 10, wherein the expanded diameter is in the range of about 19 mm to 25 mm.

12. The method of claim 1, wherein the inlet of the valve assembly is secured to a proximal end of the support frame.

13. The method of claim 12, wherein the inlet of the valve assembly is sutured to the proximal end of the support frame.

14. The method of claim 1, wherein the prosthetic valve further comprises a cuff extending along an exterior wall of the support frame.