Prosthetic heart valve and method

• US 9,937,039 B2
• Filed: 04/24/2017
• Issued: 04/10/2018
• Est. Priority Date: 10/11/2001
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Inventors: Spenser, Benjamin, Benichou, Netanel, Bash, Assaf, Zakai, Avraham
• Primary Examiner(s): Matthews, Howie
• Application Number:
  US15/495,589
• Publication Number:
  US 20170224481A1
• Time in Patent Office: 351 Days
• 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 system for replacing a deficient native aortic valve includes an implantable prosthetic valve having a self-expandable frame and a valve assembly formed with three valve leaflets. The self-expandable frame includes a plurality of support beams, each support beam having a plurality of preformed bores for allowing the valve assembly to be anchored to the frame at least in part by stitching that extends through the leaflets and through the preformed bores of the support beams. The system also includes a restriction tube adapted for insertion into a patient'"'"'s body. The prosthetic valve is capable of being crimped for insertion into the restriction tube and capable of self-expansion upon release from the restriction tube for deployment in the deficient native aortic valve.

Claims

1. A system for replacing a deficient native aortic valve, comprising:

an implantable prosthetic valve comprising a self-expandable frame and a valve assembly formed with three valve leaflets, the self-expandable frame including a plurality of support beams, each support beam having a plurality of preformed bores for allowing the valve assembly to be anchored to the frame at least in part by stitching that extends through the leaflets and through the preformed bores of the support beams, wherein each leaflet comprises opposing end portions, each end portion being paired with an adjacent end portion of an adjacent leaflet to form commissures, wherein each support beam comprises a pair of parallel, circumferentially spaced support bars and each commissure extends between the support bars of an adjacent pair of support bars; and

a restriction tube adapted for insertion into a patient'"'"'s body;

wherein the prosthetic valve is capable of being crimped for insertion into the restriction tube and wherein the prosthetic valve is capable of self-expansion upon release from the restriction tube for deployment in the deficient native aortic valve.

2. The system of claim 1, wherein the support beams are spaced equidistantly along the frame.

3. The system of claim 1, wherein the support beams are substantially parallel.

4. The system of claim 1, wherein the support beams form an integral portion of the frame.

5. The system of claim 1, further comprising a tapered tube for crimping the prosthetic valve.

6. The system of claim 1, further comprising an introducing sheath sized to slidably receive the restriction tube.

7. The system of claim 1, wherein the prosthetic valve further comprises a cuff portion disposed along an exterior of the frame.

8. The system of claim 7, wherein the cuff portion is positioned along an inlet portion of the frame.

9. The system of claim 1, wherein the frame further comprises circumferentially spaced attachment members for anchoring the prosthetic valve to surrounding tissue.

10. The system of claim 9, wherein the attachment members are hooks.

11. The system of claim 1, wherein the frame of the prosthetic valve comprises a proximal portion and a distal portion, the proximal portion sized for implantation in an aortic annulus and the distal portion sized for implantation in an ascending aorta.

12. The system of claim 11, wherein the valve assembly is positioned in the proximal portion of the frame.

13. The system of claim 11, wherein the frame is sized such that a radial gap is provided between the frame and the openings to the coronary arteries after the prosthetic valve is deployed in the deficient native aortic valve.

14. The system of claim 1, wherein the valve assembly further comprises an inner tubular portion sutured to an interior annular surface of the frame along an inlet end of the tubular portion and an outlet end of the tubular portion.

15. The system of claim 14, wherein the tubular portion comprises a fabric.

16. A system for replacing a deficient native aortic valve, comprising:

an implantable prosthetic valve comprising a self-expandable frame and a valve assembly formed with three valve leaflets, the self-expandable frame including three pairs of support beams, each leaflet comprising opposing end portions, each end portion being paired with an adjacent end portion of an adjacent leaflet to form commissures, wherein the support beams of each pair are circumferentially spaced from each other and each commissure extends between and is secured to a pair of support beams; and

a restriction tube adapted for insertion into a patient'"'"'s body;

wherein the prosthetic valve is capable of being crimped for insertion into the restriction tube and wherein the prosthetic valve is capable of self-expansion upon release from the restriction tube for deployment in the deficient native aortic valve.

17. The system of claim 16, wherein each support beam has a plurality of preformed bores for allowing the valve assembly to be anchored to the frame at least in part by stitching that extends through the leaflets and through the preformed bores of the support beams.

18. The system of claim 16, wherein the valve assembly is tapered.

19. The system of claim 16, wherein the valve assembly further comprises an inner tubular portion sutured to an interior surface of the frame along an inlet end of the tubular portion and an outlet end of the tubular portion.

20. The system of claim 19, wherein each leaflet comprises a curved inlet edge and a straight outlet edge.

21. The system of claim 20, wherein the curved inlet edge of each leaflet is secured to the outlet end of the tubular portion.

22. A system for replacing a deficient native aortic valve, comprising:

an implantable prosthetic valve comprising a self-expandable frame and a valve assembly formed with three valve leaflets, the self-expandable frame including a plurality of support beams positioned along an outlet end portion of the valve assembly, each support beam having a plurality of preformed bores for allowing the valve assembly to be anchored to the frame at least in part by stitching that extends through the leaflets and through the preformed bores of the support beams, wherein the leaflets are connected to the support beams only along the outflow end portion of the valve assembly, wherein each leaflet comprises opposing end portions, each end portion being paired with an adjacent end portion of an adjacent leaflet to form commissures, wherein each support beam comprises a pair of parallel, circumferentially spaced support bars and each commissure extends between the support bars of an adjacent pair of support bars, and wherein the valve assembly further comprising an inner tubular portion secured to an interior surface of the frame with annular stitching extending along an inlet end of the tubular portion and annular stitching extending along an outlet end of the tubular portion; and

a restriction tube adapted for insertion into a patient'"'"'s body;

wherein the prosthetic valve is capable of being crimped for insertion into the restriction tube and wherein the prosthetic valve is capable of self-expansion upon release from the restriction tube for deployment in the deficient native aortic valve.

23. The system of claim 22, wherein the frame further comprises circumferentially spaced, radially outwardly extending attachment members for anchoring the prosthetic valve to surrounding tissue.

24. The system of claim 23, wherein the frame comprises a plurality of circumferentially extending rows of angled struts comprising a first row of angled struts defining an inlet end of the frame and a second row of angled struts longitudinally spaced from the first row, and the attachment members are located adjacent the second row of struts.