Implantable prosthetic valve

• US 20040039436A1
• Filed: 08/08/2003
• Published: 02/26/2004
• 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: Zakal, Avraham, Spenser, Benjamin, Bash, Assaf, Benichu, Netanel
• Granted Patent: US 7,510,575 B2
• Time in Patent Office: Days
• US Class Current: 623/1.13
• 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:

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, the support stent provided with a plurality of longitudinally rigid support beams of fixed length; 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,

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.

2. The valve device of claim 1, wherein the support stent comprises an annular frame.

3. The valve device of claim 1, wherein said valve assembly has a tricuspid configuration.

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

5. The valve device of claim 4, wherein the valve assembly is made from pericardial tissue, or other biological tissue.

6. The valve device of claim 1, wherein said valve assembly is made from biocompatible polymers.

7. The valve device of claim 6, wherein the valve assembly is made from materials selected from polyurethane and polyethylene terephthalate.

8. The valve device of claim 7, wherein said valve assembly comprises a main body made from polyethylene terephthalate and leaflets made from polyurethane.

9. The valve device of claim 1, wherein said support stent is made from nickel titanium.

10. The valve device of claim 1, wherein the support beams are substantially equidistant and substantially parallel so as to provide anchorage for the valve assembly.

11. The valve device of claim 1, wherein the support beams are provided with bores so as to allow stitching or tying of the valve assembly to the beams.

12. The valve device of claim 1, wherein the support beams are chemically adhered to the support stent.

13. The valve device of claim 1, wherein said valve assembly is riveted to the support beams.

14. The valve device of claim 1, wherein said valve assembly is stitched to the support beams.

15. The valve device of claim 1, wherein said beams are manufactured by injection using a mold, or by machining.

16. The valve device of claim 1, wherein said valve assembly is rolled over the support stent at the inlet.

17. The valve device of claim 1, wherein said valve device is manufactured using forging or dipping techniques.

18. The valve device of claim 1, wherein said valve assembly leaflets are longer than needed to exactly close the outlet, thus when they are in the collapsed state substantial portions of the leaflets fall on each other creating better sealing.

19. The valve device of claim 1, wherein said valve assembly is made from a coiled polymer, coated by a coating layer of the same polymer.

20. The valve device of claim 19, wherein said polymer is polyurethane.

21. The valve device of claim 1, wherein the support stent is provided with heavy metal markers so as to enable tracking and determining the valve device position and orientation.

22. The valve device of claim 21, wherein the heavy metal markers are selected from gold, platinum, iridium, or tantalum.

23. The valve device of claim 1, wherein the valve assembly leaflets are provided with radio-opaque material at the outlet, so as to help tracking the valve device operation in vivo.

24. The valve device of claim 23, wherein said radio-opaque material comprises gold thread.

25. The valve device of claim 1, wherein the diameter of said support stent, when fully deployed is in the range of from about 19 to about 25 mm.

26. The valve device of claim 1, wherein the diameter of said support stent may be expanded from about 4 to about 25 mm.

27. The valve device of claim 1, wherein the support beams are provided with bores and wherein the valve assembly is attached to the support beams by means of u-shaped rigid members that are fastened to the valve assembly and that are provided with extruding portions that fit into matching bores on the support beams.

28. The valve device of claim 1, wherein the support beams comprise rigid support beams in the form of frame construction, and the valve assembly pliant material is inserted through a gap in the frame and a fastening rod is inserted through a pocket formed between the pliant material and the frame and holds the valve in position.

29. The valve device of claim 1, wherein the main body of the valve assembly is made from coiled wire coated with a coating material.

30. The valve device of claim 29, wherein the coiled wire and the coating material is made from polyurethane.

31. The valve device of claim 1, wherein a strengthening wire is interlaced in the valve assembly at the outlet of the conduit so as to define a fault line about which the collapsible slack portion of the valve assembly may flap.

32. The valve device of claim 31, wherein the strengthening-wire is made from nickel titanium alloy.

37. A crimping device for crimping the valve device of claim 1, the crimping device comprising a plurality of adjustable plates that resemble a typical SLR camera variable restrictor, each provided with a blade, that are equally dispersed in a radial symmetry but each plate moves along a line passing off an opening in the center, all plates equidistant from that center opening.

38. The crimping device of claim 37, wherein the multiple plates are adapted to move simultaneously by means of a lever and transmission.

33. A valve prosthesis device suitable for implantation in body ducts, the device comprising a main conduit body having an inlet and an outlet and pliant leaflets attached at the outlet so that when a flow passes through the conduit from the inlet to the outlet the leaflets are in an open position allowing the flow to exit the outlet, and when the flow is reversed the leaflets collapse so as to block the outlet, wherein the main body is made from polyethylene terephtalate and collapsible leaflets are made form polyurethane.

34. The valve device of claim 33, wherein support beams made from polyurethane are provided on the main body and wherein the leaflets are attached to the main body at the support beams.

35. The valve device of claim 33, wherein said support beams are chemically adhered to the main body.

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

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, the support stent provided with a plurality of longitudinally rigid support beams of fixed length;

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;

substantially equidistant rigid support beams interlaced or attached to the slack portion of the valve assembly material, arranged longitudinally.

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

an expandable support frame, the support frame provided with a plurality of longitudinally rigid support beams of fixed length; 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,

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.

40. The prosthetic device of claim 39, wherein the expandable support frame comprises 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.

41. The prosthetic device of claim 39, wherein the support beams have a U-shaped cross section.

42. The prosthetic device of claim 41, wherein a holder is used to secure the pliant material to the support beams.

43. The prosthetic device of claim 39, wherein the support frame comprises three segments that form a circular assembly when assembled.

44. The prosthetic device of claim 39, wherein the support beams point inwardly with respect to a central longitudinal axis of the device.

45. The prosthetic device of claim 43, wherein the support beams point outwardly with respect to a central longitudinal axis of the device.

46. The prosthetic device of claim 39, further provided with a restricting tapered housing, for housing it in a crimped state

47. The prosthetic device of claim 39, wherein hooks are provided to secure the device in position after it is deployed.

48. The prosthetic device of claim 39, wherein the support beams comprise longitudinal bars having a narrow slit used as the commissural attachment so that extensions the pliant material are tightly inserted through it.

49. The prosthetic device of claim 48, wherein the extensions of the pliant material are wrapped about rigid bars serving as anchorage means.

50. The prosthetic device of claim 49, wherein extensions of the pliant material are sutured to each other at the rigid bars.

51. The prosthetic device of claim 50, wherein a bottom portion of the pliant material is attached to the inlet.

52. The prosthetic device of claim 39, wherein the support beams are each provided with a rounded pole, forming a loop through which the pliant material is inserted.

53. The prosthetic device of claim 39, wherein the pliant material is provided with longitudinal bars attached to the pliant material at positions assigned for attachment to the support frame, in order to prevent localized stress from forming.

54. The prosthetic device of claim 39, further provided with longitudinal bars having protrusions that are inserted in bores in the pliant material, a sheet of PET and through bores provided on the support beams.

55. The prosthetic device of claim 39, wherein the pliant material is sutured leaving the slack portions free of sutures.

56. The prosthetic device of claim 39, wherein a connecting member with a split portion is used to connect leaflets of the pliant material to the support beams, the split connecting member compressing the pliant material in position.

57. The prosthetic device of claim 56, wherein a portion of the connecting member is perpendicular to the split portion.

58. The prosthetic device of claim 39, wherein the support frame is provided with metallic members coupled to the stent and rigid members are positioned on two opposite sides of the metallic member and held against each other, holding portion of the pliant material between them, sutured, the metallic members wrapped with PET.

59. The prosthetic device of claim 39, wherein the device is further provided with spring in order to reduce wear of the pliant material.

60. The prosthetic device of claim 59, wherein the spring is provided with a spiral.

61. The prosthetic device of claim 59, wherein the spring is made from stainless steel.

62. The prosthetic device of claim 59, wherein the spring is attached to slots provided on the support frame.

63. The prosthetic device of claim 39, wherein the pliant material is sutured to the support frame forming pockets.

64. The prosthetic device of claim 63, wherein attachment bars are provided on the stent support at a portion of the stent close to the outlet, on which the pliant material is coupled to, and wherein the pliant material is attached circumferentially to the inlet, leaving slack pliant material.

65. The prosthetic device of claim 39, wherein the outlet is tapered with respect to the inlet.

66. The prosthetic device of claim 65, wherein the support frame at the outlet is wider in diameter than the pliant material forming the outlet.

67. The prosthetic device of claim 39, wherein the pliant material is reinforced using PET.

68. The prosthetic device of claim 39, wherein the support frame is a tube having an inner wall, having sinusoidal fold lines, wherein the pliant material is sutured to the inner wall of the tube along suture lines.

69. The prosthetic device of claim 68, wherein additional piece of PET is added below the suture lines.

70. The prosthetic device of claim 39, wherein the device is incorporated with an angioplasty balloon.

71. The prosthetic device of claim 70, wherein the balloon has a central longitudinal axis that runs along a flow path through the device, and a perimeter, the balloon comprising four inflatable portions, one portion located along a central axis and the other three located on the perimeter, the pliant material in the form of leaflets is distributed about the perimeter.