Prosthetic heart valve and method

• US 9,629,717 B2
• Filed: 10/20/2015
• Issued: 04/25/2017
• 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:
  US14/918,297
• Publication Number:
  US 20160038284A1
• Time in Patent Office: 553 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 prosthetic heart valve assembly suitable for implantation in body ducts via a catheter. The prosthetic heart valve assembly includes a collapsible and expandable tubular frame having an inlet end and an outlet end. The frame is preferably made from a self-expanding material. Three pericardial leaflets form a tricuspid valve having a top portion, a middle portion, and a bottom portion. Three longitudinal support members are positioned along an internal surface of the frame, desirably proximate to the outlet end. Each support member includes a pair of longitudinal surfaces that extends radially inwardly. End portions of adjacent valve leaflets extend through a gap between the pairs of longitudinal surfaces of each support member. The end portions are sutured to the longitudinal support members. The bottom portion of the tricuspid valve is sutured to the inlet end of the frame.

Claims

1. A prosthetic heart valve assembly suitable for implantation in body ducts via a catheter, comprising:

a collapsible and expandable frame having an inlet end and an outlet end;

three pericardial leaflets forming a tricuspid valve wherein the tricuspid valve includes a top portion, a middle portion, and a bottom portion; and

three equidistantly spaced support members positioned proximate to the outlet end of the frame along an internal surface of the frame, each support member having a plurality of circular bores extending therethrough;

wherein the three support members are positioned at least along the top portion of the tricuspid valve such that the top portion of the tricuspid valve is secured to the three support members by sutures extending through the bores and the bottom portion of the tricuspid valve is secured with sutures to the inlet end of the frame along a circumference of the tricuspid valve; and

wherein a pair of longitudinal surfaces of each support member extends radially inward such that end portions of adjacent valve leaflets along the top portion of the tricuspid valve extend between the pairs of the radially extended longitudinal surfaces of each support member.

2. The prosthetic heart valve assembly of claim 1, wherein each support member comprises a pair of longitudinally extending parallel support bars, each bar defining one of the longitudinal surfaces of the support member, the plurality of circular bores of each support member comprising a plurality of circular bores in each support bar of each pair of support bars through which the sutures extend to secure the top portion of the tricuspid valve to the support members.

3. The prosthetic heart valve assembly of claim 1, wherein the radially extended longitudinal surfaces of each support member have a corresponding hole and wherein the end portions of the adjacent leaflets that extend between the radially extended longitudinal surfaces are threaded through the corresponding holes and sutured to the radially extended longitudinal surfaces of the support members.

4. The prosthetic heart valve assembly of claim 1, wherein the end portion of each leaflet also extends between the internal surface of the frame and one of the support members.

5. The prosthetic heart valve assembly of claim 1, wherein each support member comprises a pair of longitudinally extending parallel support bars, each bar defining one of the longitudinal surfaces of the support member.

6. The prosthetic heart valve assembly of claim 1, wherein the tricuspid valve has an inlet end and an outlet end and wherein the outlet end of the frame is wider in diameter than the diameter of the outlet end of the tricuspid valve.

7. The prosthetic heart valve assembly of claim 6, wherein the outlet end of the tricuspid valve is tapered with respect to the inlet end of the tricuspid valve.

8. The prosthetic heart valve assembly of claim 1, wherein the support members have U-shaped lateral cross sections.

9. The prosthetic heart valve assembly of claim 1, wherein the frame is self-expanding.

10. The prosthetic heart valve assembly of claim 1, wherein the support members are positioned only along the top portion of the tricuspid valve.

11. The prosthetic heart valve assembly of claim 1, wherein the top portion of the tricuspid valve is the top third of the tricuspid valve.

12. The prosthetic heart valve assembly of claim 1, wherein the height of the pericardial leaflets is greater than the height of the frame in its expanded state.

13. A prosthetic heart valve assembly suitable for implantation in body ducts via a catheter, comprising:

a collapsible and expandable annular frame having an inlet end and an outlet end;

three pericardial leaflets forming a tricuspid valve wherein the tricuspid valve includes a top portion, a middle portion, and a bottom portion; and

three equidistantly spaced support members positioned proximate to the outlet end of the frame along an internal surface of the annular frame, each support member having at least a lower portion mounted inside of the annular frame;

wherein the three support members are positioned at least along the top portion of the tricuspid valve such that the top portion of the tricuspid valve is secured with sutures to the three support members, the middle portion of the tricuspid valve includes a slack portion, and the bottom portion of the tricuspid valve is secured with sutures to the inlet end of the frame along the circumference of the tricuspid valve; and

wherein a pair of longitudinal surfaces of each support member extends radially inward such that end portions of adjacent valve leaflets along the top portion of the tricuspid valve extend between the pairs of the radially extended longitudinal surfaces of each support member.

14. The prosthetic heart valve assembly of claim 13, wherein each support member has a plurality of bores to allow stitching or tying of the tricuspid valve to the support members.

15. The prosthetic heart valve assembly of claim 13, wherein the end portion of each leaflet also extends between the internal surface of the frame and one of the support members.

16. The prosthetic heart valve assembly of claim 13, wherein the tricuspid valve has an inlet end and an outlet end and wherein the outlet end of the frame is wider in diameter than the diameter of the outlet end of the tricuspid valve.

17. The prosthetic heart valve assembly of claim 13, wherein the frame is self-expanding.

18. The prosthetic heart valve assembly of claim 13, wherein the support members are positioned only along the top portion of the tricuspid valve.

19. The prosthetic heart valve assembly of claim 13, wherein the top portion of the tricuspid valve is the top third of the tricuspid valve.

20. A prosthetic heart valve assembly suitable for implantation in body ducts via a catheter, comprising:

a collapsible and expandable annular frame having an inlet end, an outlet end;

three longitudinal support members mounted to an inside surface of the frame, each longitudinal support member positioned proximate to the outlet end of the frame, each longitudinal support member provided with a pair of corresponding projections that extend radially inward relative to the inside surface of the frame, wherein each projection comprises a plurality of bores; and

a valve assembly including three leaflets made of pericardial tissue;

wherein end portions of adjacent leaflets extend between the pairs of corresponding projections and wherein the leaflets are secured to the longitudinal support members by sutures extending through the leaflets and through the bores of each projection and wherein a bottom portion of the valve assembly is stitched to the inlet end of the annular frame along a circumference of the valve assembly.

21. The prosthetic heart valve assembly of claim 20, wherein each pair of corresponding projections extends only along a top portion of the valve assembly.

22. The prosthetic heart valve assembly of claim 21, wherein the end portions of the leaflets wrap around the projections.

23. The prosthetic heart valve assembly of claim 20, further comprising an annular cuff provided along an exterior surface of the annular frame, the cuff extending from the inlet end of the annular frame toward the outlet end.

24. The prosthetic heart valve assembly of claim 21, wherein a middle portion of the valve assembly includes a slack portion.

25. The prosthetic heart valve assembly of claim 20, wherein at each pair of corresponding projections, the end portion of one leaflet is folded at least partially around and stitched to one of the projections of the respective pair of projections and the end portion of the adjacent leaflet is folded at least partially around and stitched to the other projection of the respective pair of projections.

26. The prosthetic heart valve assembly of claim 25, wherein at each pair of corresponding projections, sutures extend through a first layer of one end portion of a leaflet, through the bores of one of the projections, through a second layer of the one end portion of the leaflet, through a first layer of the end portion of the other leaflet, through the bores of the other projection, and through a second layer of the end portion of the other leaflet.

27. The prosthetic heart valve assembly of claim 20, wherein the bores extend through the projections in a circumferential direction with respect to a longitudinal axis of the annular frame.

28. A prosthetic heart valve assembly suitable for implantation in body ducts via a catheter, comprising:

a collapsible and expandable annular support frame adapted to be initially crimped in a narrow configuration for catheterization through a body duct to a target location, the support frame made from a nickel-titanium, shape memory alloy;

a valve assembly comprising a flexible conduit, the valve assembly made of pliant material forming a tricuspid valve assembly having three leaflets; and

three pairs of parallel bars for attaching the valve assembly to the support frame, each bar of each pair of parallel bars including preformed bores extending therethrough;

wherein each pair of parallel bars is connected to a respective connecting member;

wherein end portions of the leaflets extend between the pairs of parallel bars and sutures extend through the end portions of the leaflets and through the preformed bores for attaching the leaflets to the parallel bars.

29. The prosthetic heart valve assembly of claim 28, wherein at each pair of parallel bars, the end portion of one leaflet is folded partially around and stitched to one of the bars of the respective pair of parallel bars and the end portion of the adjacent leaflet is folded partially around and stitched to the other bar of the respective pair of parallel bars.

30. The prosthetic heart valve assembly of claim 28, wherein the pairs of parallel bars are positioned along a top portion of the valve assembly.

31. The prosthetic heart valve assembly of claim 30, wherein a bottom portion of the valve assembly is stitched to an inlet end portion of the support frame along a circumference of the support frame inlet end portion.

32. The prosthetic heart valve assembly of claim 31, wherein the valve assembly comprises a middle slack portion between the top portion and the bottom portion, wherein the middle slack portion can collapse away from the support frame toward a center of the prosthetic heart valve assembly.

33. The prosthetic heart valve assembly of claim 28, wherein the preformed bores are longitudinally spaced from each other along a length of each bar.

34. The prosthetic heart valve assembly of claim 28, wherein each connecting member interconnects upper end portions of the bars of a respective pair of parallel bars.

35. The prosthetic heart valve assembly of claim 34, wherein each connecting member connects a respective pair of parallel bars to the annular support frame.