Implantable prosthetic valve

• US 7,510,575 B2
• Filed: 08/08/2003
• Issued: 03/31/2009
• Est. Priority Date: 10/11/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Private Incorporated (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Benichu, Netanel, Zakai, Avraham, Spenser, Benjamin, Bash, Assaf
• Primary Examiner(s): Matthews; William H.
• Application Number:
  US10/637,882
• Publication Number:
  US 20040039436A1
• Time in Patent Office: 2,062 Days
• Field of Search: 623 11- 113, 623/1.15, 623/1.24, 623/1.26, 623/1.34, 623 21- 215, 623/2.17, 623/2.18
• 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 valve prosthesis device is disclosed suitable for implantation in body ducts. The device comprises a support stent, comprised of a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location, and a valve assembly comprising a flexible conduit having an inlet end and an outlet, made of pliant material attached to the support beams providing collapsible slack portions of the conduit at the outlet. The support stent is provided with a plurality of longitudinally rigid support beams of fixed length. When flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, the valve assembly is kept in an open position, whereas a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow.

Claims

1. A valve prosthesis device suitable for implantation in body ducts, the device comprising:

an annular support stent having a crimped configuration suitable for delivery through a body duct and an expanded configuration adapted for engagement with tissue at a target location, the support stent having a circular profile in the expanded configuration, the support stent including a plurality of longitudinally rigid support beams of fixed length and a plurality of annularly spaced expandable web-like constructions extending and connected between the support beams to form the circular profile; and

a valve assembly made of pliant material and having an inlet and an outlet, the valve assembly being an anchored at least in part to the support beams,

whereby, when flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, the valve assembly is kept in an open position, whereas a reverse flow is prevented as collapsible slack portions of the valve assembly between the support beams collapse inwardly providing blockage to the reverse flow.

2. The device of claim 1, wherein the support beams are provided with bores for allowing stitching or tying the valve assembly to the support beams.

3. The device of claim 1, wherein the support stent includes three support beams and the valve assembly has a tricuspid configuration.

4. The device of claim 1, wherein the valve assembly is made from biocompatible material.

5. The device of claim 4, wherein the support stent is made from nickel titanium.

6. The device of claim 1, further comprising at least one radiopaque marker on the support stent.

7. The device of claim 6, wherein the at least one radiopaque marker on the support stent is made of a heavy metal material.

8. The device of claim 1, wherein the valve assembly is anchored to both the support beams and web.

9. The device of claim 1, wherein the valve assembly comprises separate leaflets and further including longitudinal bars separate from the support stent around which ends of each pair of adjacent leaflets roll and attach at the commissures.

10. The device of claim 1, further including a fabric layer interposed between the valve assembly and support stent and to which both are stitched.

11. The device of claim 10, wherein the valve assembly has spaced commissure portions attached longitudinally to the support beams of the support stent so as to provide therebetween collapsible slack portions in the pliant material at the outlet.

12. The device of claim 11, wherein the support beams each has a series of bores formed therein, and wherein valve assembly is stitched to the bores of the support beams.

13. The device of claim 11, wherein the valve assembly has a tricuspid configuration with three commissures.

14. The device of claim 10, wherein the valve assembly is made from biocompatible material.

15. The device of claim 14, wherein the support stent is made from nickel titanium.

16. The device of claim 10, further comprising at least one radiopaque marker on the support stent.

17. The device of claim 16, wherein the at least one radiopaque marker on the support stent is made of a heavy metal material.

18. The device of claim 11, wherein the valve assembly is anchored to both the support beams and web.

19. The device of claim 10, wherein the valve assembly comprises separate leaflets and further including longitudinal bars separate from the support stent around which ends of each pair of adjacent leaflets roll and attach at the commissures.

20. A valve prosthesis device suitable for implantation in body ducts, the device comprising:

a support stent adapted to be initially crimped in a narrow configuration suitable for delivery through a body duct to a target location and adapted to be deployed to a larger diameter deployed state at the target location, the support stent being tubular and having an axial length in its deployed state and including collapsible and expandable web-like portions extending between and directly connecting a plurality of longitudinally rigid support beams of fixed length distributed around a circumference of the support stent and extending co-extensively with the support stent wherein the web-like portions and support beams are connected at a plurality of locations along the axial length of the support stent;

a valve assembly made of pliant material and having an inlet and an outlet, the valve assembly including a plurality of commissures each of which attaches to a support beam for providing collapsible slack portions between the support beams at the outlet;

whereby, when flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, the valve assembly is kept in an open position, whereas a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow.

21. The device of claim 20, wherein the support beams are provided with bores for allowing stitching or tying the valve assembly to the support beams.

22. The device of claim 20, wherein the valve assembly is stitched to the support beams.

23. The device of claim 20, wherein the support stent includes three support beams and the valve assembly has a tricuspid configuration.

24. The device of claim 20, wherein the valve assembly is made from biocompatible material.

25. The device of claim 24, wherein the support stent is made from nickel titanium.

26. The device of claim 20, further comprising at least one radiopaque marker on the support stent.

27. The device of claim 26, wherein the at least one radiopaque marker on the support stent is made of a heavy metal material.

28. The device of claim 20, wherein the support stent frame further includes a radially collapsible web between adjacent support beams, and wherein the valve assembly is anchored to both the support beams and web.

29. The device of claim 20, wherein the valve assembly comprises separate leaflets and further including longitudinal bars separate from the support stent around which ends of each pair of adjacent leaflets roll and attach at the commissures.

30. The device of claim 20, further including a fabric layer interposed between the valve assembly and support stent and to which both are stitched.

31. The device of claim 30, wherein a portion of the fabric layer forms a cuff that is wrapped around the support stent at an inlet thereof.