Tissue distention device and related methods for therapeutic intervention

• US 20050049681A1
• Filed: 05/19/2004
• Published: 03/03/2005
• Est. Priority Date: 05/19/2003
• Status: Active Grant

• Current Assignee: SeptRx, Inc.
• Original Assignee: SECANT MEDICAL, LLC (Compagnie Generale DES Etablissements Michelin SCA)
• Inventors: Kleshinski, Stephen J., Greenhalgh, E. Skott
• Granted Patent: US 7,122,043 B2
• Time in Patent Office: Days
• US Class Current: 623/1.150
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2250/0039 : differing in diameter

Abstract

A device positionable in an opening in a flexible membrane or in the lumen of a vessel having a flexible sidewall. The device distends or biases opposite portions defining the opening or forming the vessel sidewall outwardly in the plane of the device. The outward biasing draws opposing portions of the opening or sidewall inwardly in a direction perpendicular to the plane of the device and into apposition or contact.

Claims

1. A biasing device positionable within a body opening defined by a flexible sidewall, said biasing device having a first collapsible configuration to facilitate insertion through a catheter and being automatically expandable toward a second configuration when released from said catheter, the biasing device comprising:

at least first and second side wall engaging members for respectively engaging and expanding outwardly opposed portions of said sidewall on opposite sides of said opening during expansion of said biasing device; and

at least one expandable and contractible joinder member connected between the said first and second sidewall engaging members, said joinder member being formed to contract to position said sidewall engaging members proximate to one another for insertion in a catheter and to expand upon release of said biasing device from said catheter to move said sidewall engaging members apart and into contact in substantially the same plane with said opposed portions of said sidewall on opposite sides of said opening and to subsequently expand said opposed sidewalls.

2. The biasing device of claim 1, wherein said sidewall engaging members are provided with an anchoring mechanism to engage the sidewall and attach the sidewall engaging members to the sidewall.

3. The biasing device of claim 2, wherein said anchoring mechanism is an anchoring substrate formed by interlacing a plurality of filamentary members to define a plurality of interstices between said filamentary members.

4. The biasing device of claim 3, wherein said plurality of interstices are sized to promote the intergrowth of living tissue onto the anchoring substrates.

5. The biasing device of claim 3, wherein said filamentary members are coated with at least one of thrombin, collagen, hyluron and a host growth factor.

6. The biasing device of claim 2, wherein portions of the device other than the anchoring mechanism are coated with an antiproliferative drug.

7. The biasing device of claim 6, wherein said antiproliferative drug is at least one of Taxol, Rapamycin, and Rapamune.

8. The biasing device of claim 3, wherein the filamentary members comprise a polymer.

9. The biasing device of claim 3, wherein the filamentary members comprise a metal.

10. The biasing device of claim 8, wherein said polymer is at least one of polyester, polypropylene, polytetrafluoroethylene, and nylon.

11. The biasing device of claim 9, wherein said metal is gold.

12. The biasing device of claim 2, wherein the anchoring mechanism is formed by at least one or more hooks extending outwardly from each sidewall engaging member.

13. The biasing device of claim 1, wherein said first and second sidewall engaging members each include an elongate leg segment for engaging said sidewall, said at least one joinder member maintaining the first and second sidewall members in substantially coplanar relationship.

14. The biasing device of claim 1, wherein a shroud surrounds at least part of at least one of the first and second sidewall engaging members and the joinder members.

15. The biasing device of claim 1, wherein a shroud comprises a substantially form fitting bag in which the biasing device is sealed.

16. The biasing device of claim 14, wherein said shroud is formed of a polymer.

17. The biasing device of claim 14, wherein said shroud is formed of a metal.

18. The biasing device of claim 16, wherein said polymer is at least one of polyester, polytetrafluoroethylene, nylon, polypropylene, polyethylene, and silicone.

19. The biasing device of claim 17, wherein said metal is at least one of a shape memory metal or a stainless steel alloy.

20. The biasing device of claim 14, wherein the shroud is coated with at least one of thrombin, collagen, hyluron or a host growth factor.

21. The biasing device of claim 1, wherein said first and second sidewall engaging members are coplanar.

22. The biasing device of claim 1, wherein said joinder member is a stress release loop.

23. The biasing device of claim 22, wherein said stress release loop has a predetermined radius of curvature.

24. The biasing device of claim 3, wherein said filamentary members comprise a radiopaque material.

25. The biasing device of claim 24, wherein said radiopaque material is selected from the group consisting of gold, barium and titanium.

26. The biasing device of claim 3, wherein said filamentary members have a radiopaque coating.

27. The biasing device of claim 3, wherein said filamentary members of each anchoring substrate are braided together to form a tube positioned coaxially with said first and second sidewall engaging members.

28. A biasing device positionable within a body opening defined by a flexible sidewall, said biasing device having a first collapsible configuration to facilitate insertion through a catheter and being automatically expandable toward a second configuration when released from said catheter, the biasing device comprising:

at least one leg segment attached to a first collar;

at least one leg segment attached to a second collar;

a first anchoring member; and

a second anchoring member.

29. The device of claim 28, wherein a guide wire is insertable through said first and second collars.

30. The device of claim 28, wherein at least one of said first and second collars comprise a radiopaque material.

31. The device of claim 30, wherein said radiopaque material is selected from the group consisting of gold, barium and tantalum.

32. The device of claim 28, wherein at least one of said first anchoring member and second anchoring member is an anchoring substrate formed by interlacing a plurality of filamentary members to define a plurality of interstices between said filamentary members.

33. The device of claim 32, wherein said filamentary members are coated with at least one of thrombin, collagen, hyluron and a host growth factor.

34. The device of claim 28, wherein portions of the device other than said first anchoring member and second anchoring member are coated with an antiproliferative drug.

35. The device of claim 34, wherein said antiproliferative drug is at least one of Taxol, Rapamycin and Rapamune.

36. The device of claim 32, wherein the filamentary members comprise a polymer.

37. The device of claim 32, wherein the filamentary members comprise a metal.

38. The device of claim 36, wherein said polymer is at least one of polyester, polypropylene, polytetrafluoroethylene, and nylon.

39. The device of claim 37, wherein said metal is gold.

40. The device of claim 28, wherein at least a portion of at least one of said first anchoring member and second anchoring member comprises a tissue engaging hook.

41. The device of claim 28, wherein said first anchoring member engages the left atria.

42. The device of claim 28, wherein said second anchoring member engages said flexible sidewall.

43. The device of claim 28, further comprising a shroud.

44. The device of claim 43, wherein said shroud surrounds at least one of said leg segments.

45. The device of claim 43, wherein said shroud is formed of a polymer.

46. The biasing device of claim 43, wherein said shroud is formed of a metal.

47. The biasing device of claim 45, wherein said polymer is at least one of polyester, polytetrafluoroethylene, nylon, polypropylene, polyethylene, and silicone.

48. The biasing device of claim 46, wherein said metal is at least one of a shape memory metal and a stainless steel alloy.

49. The biasing device of claim 43, wherein the shroud is coated with at least one of thrombin, collagen, hyluron or a host growth factor.

50. The biasing device of claim 28, wherein at least part of at least said first anchor is covered by tantalum coil.

51. A tissue distension method comprising:

positioning a biasing device in an opening defined by a flexible sidewall, wherein the biasing device comprises at least first and second sidewall engaging members, and at least one expandable and contractable joinder member connected between the first and second sidewall engaging members; and

biasing a first opposing sidewall portion in a plane of the device outwardly from one another while drawing a second opposing sidewall portion toward one another in a direction substantially perpendicular to the plane of the device and into apposition or contact.

52. The method of claim 51 further comprising the step of anchoring said biasing device within said opening.

53. The method of claim 51, wherein said flexible side wall is the sidewall of a valve.

54. The method of claim 53, wherein said valve is a mitral valve.

55. The method of claim 53, wherein said valve is a venous valve.

56. The method of claim 51, wherein said flexible side wall is the sidewall of an aneurysm.

57. The method of claim 56, wherein said aneurysm is a saccular aneurysm.

58. The method of claim 51, wherein said flexible sidewall is the sidewall of an atrial appendage.

59. The method of claim 51, wherein said flexible sidewall is the sidewall of the foramen ovale.

60. The method of claim 51, wherein said flexible sidewall is the sidewall of the esophagus.

61. The method of claim 51, wherein said flexible sidewall is the sidewall of a urethra.

62. The method of claim 51, wherein said flexible sidewall is the sidewall of a stomach.

63. The method of claim 51, wherein said flexible sidewall is the sidewall of a fallopian tube.

64. The method of claim 51, wherein the flexible sidewall is the sidewall of a vas deferens.

65. The method of claim 51, wherein the flexible sidewall comprises at least one of muscle tissue, epithelial tissue, nerve tissue, and connective tissue.

66. The method of claim 51, wherein said device is positioned within said opening using a catheter.

67. A method of closing a body opening defined by a flexible sidewall, comprising:

contacting first and second portions of said sidewall on opposite sides of body opening;

simultaneously expanding said first and second opposed portions of said sidewall away from one another;

continuing said expansion of said first and second sidewall portions to draw opposing sections of side wall between said first and second portions of said sidewall together to close said body opening.

68. The method of claim 67, which includes placing a web of filamentary material across said body opening in a plane which extends between said first and second opposed portions of said sidewall;

and

drawing said opposing sections of said sidewall between said first and second opposed portions of said sidewall together into contact with said web of filamentary material.

69. The method of claim 67, wherein said flexible side wall is the sidewall of a valve.

70. The method of claim 69, wherein said valve is a mitral valve.

71. The method of claim 69, wherein said valve is a venous valve.

72. The method of claim 67, wherein said flexible side wall is the sidewall of an aneurysm.

73. The method of claim 67, wherein said aneurysm is a saccular aneurysm.

74. The method of claim 67, wherein said flexible sidewall is the sidewall of an atrial appendage.

75. The method of claim 67, wherein said flexible sidewall is the sidewall of the foramen ovale.

76. The method of claim 67, wherein said flexible sidewall is the sidewall of the esophagus.

77. The method of claim 67, wherein said flexible sidewall is the sidewall of a urethra.

78. The method of claim 67, wherein said flexible sidewall is the sidewall of a stomach.

79. The method of claim 67, wherein said flexible sidewall is the sidewall of a fallopian tube.

80. The method of claim 67, wherein the flexible sidewall is the sidewall of a vas deferens.

81. The method of claim 67, wherein the flexible sidewall comprises at least one of muscle tissue, epithelial tissue, nerve tissue, and connective tissue.

82. The method of claim 67, wherein said device is positioned within said opening using a catheter.

83. A method of closing a body valve positioned within an opening defining a flexible sidewall wherein the valve is formed by a pair of opposing valve leaflets extending from first and second opposite sections respectively of said sidewall to define an opening plane therebetween, comprising:

placing a web of filamentary material in said opening plane between said pair of opposing valve leaflets;

contacting two opposed portion of said sidewall which lie respectively on opposite sides of said valve leaflets in a plane substantially coextensive with said opening plane;

simultaneously expanding said two opposed portions of said sidewall outwardly away from one another; and

continuing said expansion to draw said first and second opposing sections of said sidewall inwardly toward said opening plane to bring said opposing valve leaflets together against said filamentary web.

84. The method of claim 83, wherein said valve is a one-way valve.

85. The method of claim 83, wherein said valve is a mitral valve.

86. The method of claim 83, wherein said valve is a venous valve.