Septal occluder and associated methods

• US 7,867,250 B2
• Filed: 12/19/2002
• Issued: 01/11/2011
• Est. Priority Date: 12/19/2001
• Status: Expired due to Term

• Current Assignee: WL Gore and Associates Incorporated (W.L. Gore and Associates)
• Original Assignee: NMT Medical Incorporated
• Inventors: Ryan, Carol A., Chanduszko, Andrzej J.
• Primary Examiner(s): Erezo; Darwin P
• Application Number:
  US10/326,535
• Publication Number:
  US 20030191495A1
• Time in Patent Office: 2,945 Days
• Field of Search: 606/216, 606/213, 606/215, 606/200, 602/213, 602/215
• US Class Current: 606/215
• 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 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: H04M 1/68 Circuit arrangements for preventing eavesdropping
• CPC Class Codes: H04M 1/715 using two or more extensions per line cordless telephones H04M1/725
• CPC Class Codes: H04M 1/72505 Radio link set-up procedures
• CPC Class Codes: H04W 84/14 WLL [Wireless Local Loop]; RLL [Radio Local Loop]

Abstract

Devices are provided for closing septal defects such as PFOs. The devices generally include a proximal anchor member, a distal anchor member, and a flexible center joint connecting the two anchor members.

Claims

1. A septal occluder, comprising:

a proximal generally cylindrically shaped anchor member having an axial length and an outer surface for deployment proximate a first end of a septal defect;

a distal generally cylindrically shaped anchor member having an axial length and an outer surface for deployment proximate a second end of said septal defect; and

a flexible connection layer, having a width and a length, fixedly attached to said proximal anchor member along a proximal attachment line and fixedly attached to said distal anchor member along a distal attachment line, the proximal attachment line extending in an axial direction on the outer surface of the proximal anchor member, the distal attachment line extending in an axial direction on the outer surface of the distal anchor member, and at least one of the distal attachment line and proximal attachment line being along the width of the flexible connection layer;

said proximal and distal anchor members and said flexible connection layer comprising one or more bioresorbable materials.

2. The septal occluder of claim 1 wherein said proximal and distal anchor members each have a first end and a second end and wherein each of the first ends and second ends are rounded.

3. The septal occluder of claim 1 wherein said proximal and distal anchor members each comprise a cylindrical structure formed by rolling a layer of material.

4. The septal occluder of claim 1 wherein said proximal and distal anchor members are inflatable.

5. The septal occluder of claim 1 wherein said septal occluder is collapsible for passage through a catheter or sheath.

6. The septal occluder of claim 5 wherein said occluder can be collapsed with the proximal and distal anchor members being in a generally aligned, end to end arrangement for passage through a catheter or sheath.

7. The septal occluder of claim 1 wherein said proximal and distal anchor members are collapsible for deployment or removal.

8. The septal occluder of claim 7 wherein the proximal and distal anchor members are generally foldable.

9. The septal occluder of claim 8 wherein each anchor member includes two elements separated by an elastic hinge.

10. The septal occluder of claim 1 further comprising a removal string attached to the septal occluder to facilitate removal of the septal occluder from the septal defect.

11. The septal occluder of claim 10 wherein said removal string is slidingly mounted in said proximal anchor member and attached to said distal anchor member.

12. The septal occluder of claim 10 wherein said removal string is mounted to slide through said proximal anchor member.

13. The septal occluder of claim 10 further comprising a delivery string to facilitate deployment of the septal occluder at the septal defect.

14. The septal occluder of claim 1 wherein said septal occluder is formed from a layer of material having opposite ends rolled to form the proximal and distal anchor members.

15. The septal occluder of claim 1 further comprising a wire connecting said proximal and distal anchor members to provide clamping force to close the defect.

16. The septal occluder of claim 15 wherein said wire has a serpentine configuration.

17. The septal occluder of claim 1 wherein said flexible connection layer comprises a layer of elastomeric material.

18. The septal occluder of claim 1 wherein said flexible connection layer comprises a layer of material made from thrombogenic or inflammatory materials.

19. The septal occluder of claim 1 wherein said flexible connection layer comprises a layer of material that is porous or textured.

20. The septal occluder of claim 1 wherein said flexible connection layer comprises a layer of material that is covered with a biocompatible glue to promote adherence to tissue.

21. The septal occluder of claim 1 wherein said flexible connection layer comprises a layer of material that is covered with growth factors to accelerate tissue ingrowth.

22. The septal occluder of claim 1, wherein at least one of said proximal and distal anchor members is configured to move pivotally relative to said flexible connection layer.

23. A septal defect closure device, comprising:

an elongated proximal anchor member, having a length along a longitudinal axis longer than its transverse dimension for deployment proximate a first end of a septal defect;

an elongated distal anchor member, having a length along a longitudinal axis longer than its transverse dimension, for deployment proximate a second end of said septal defect; and

a flexible layer having a width and a length, said flexible layer being fixedly attached to said proximal anchor member at a first connection location and fixedly attached to said distal anchor member at a second connection location, wherein at least one of the first and second connection locations forms a juncture line along the width of the flexible layer and along a portion of an axial length of the corresponding anchor member.

24. The device of claim 23 wherein said flexible layer comprises thrombogenic or inflammatory materials.

25. The device of claim 23 wherein said flexible layer is porous or textured.

26. The device of claim 23 wherein said flexible layer is covered with a biocompatible glue to promote adherence to tissue.

27. The device of claim 23 wherein said flexible layer is covered with growth factors to accelerate tissue ingrowth.

28. The device of claim 23 wherein said flexible layer comprises a resilient elastomeric material.

29. The device of claim 23 wherein said flexible layer comprises a plurality of fibers connecting the anchor members.

30. The device of claim 23 wherein said proximal and distal anchor members each have a generally cylindrical shape with rounded ends.

31. The device of claim 23 wherein a side of each anchor member for contacting a tissue surface is generally flattened to increase surface contact.

32. The device of claim 23 wherein said proximal and distal anchor members each comprise a cylindrical structure formed by rolling a layer of material.

33. The device of claim 23 wherein said proximal and distal anchor members are inflatable.

34. The device of claim 23 wherein said device is collapsible for passage through a catheter or sheath.

35. The device of claim 34 wherein said occluder can be collapsed with the proximal and distal anchor members being in a generally aligned, end to end arrangement for passage through a catheter or sheath.

36. The device of claim 23 wherein said proximal and distal anchor members are collapsible for deployment or removal.

37. The device of claim 36 wherein the proximal and distal anchor members are generally foldable.

38. The device of claim 37 wherein each anchor member includes two elements separated by an elastic hinge.

39. The device of claim 23 further comprising a removal string attached to the device to facilitate removal of the device from the septal defect.

40. The device of claim 39 wherein said removal string is slidingly mounted in said proximal anchor member and attached to said distal anchor member.

41. The device of claim 39 wherein said removal string is mounted to slide through said proximal anchor member.

42. The device of claim 39 further comprising a delivery string to facilitate deployment of the device at the septal defect.

43. The device of claim 23 wherein said device is formed from a layer of material having opposite ends rolled to form the proximal and distal anchor members.

44. The device of claim 23 further comprising a wire connecting said proximal and distal anchor members to provide clamping force to close the defect.

45. The device of claim 44 wherein said wire has a serpentine configuration.

46. A septal defect closure device, comprising:

a generally cylindrically shaped proximal anchor member for deployment proximate a first end of a septal defect, the proximal member has a length along an axial dimension that is greater than the transverse dimension and an outer surface;

a distal anchor member having an outer surface for deployment proximate a second end of said septal defect;

a flexible connection layer, having a width and a length, fixedly attached to said proximal anchor along a proximal attachment line and fixedly attached to said distal anchor member along a distal attachment line,

wherein the flexible connection layer is fixedly attached to the proximal anchor member during delivery of the device to the septal defect,

wherein the proximal attachment line extends in an axial direction on the outer surface of the proximal anchor member, the distal attachment line extends in an axial direction on the outer surface of the distal anchor member, and at least one of the distal attachment line and proximal attachment line being along the width of the flexible connection layer; and

a removal string extending from said proximal anchor member to facilitate collapsing and removal of the device from the septal defect.

47. The device of claim 46 wherein said removal string is slidingly mounted in said proximal anchor member and attached to said distal anchor member.

48. The device of claim 46 wherein said removal string is mounted to slide through said proximal anchor member.

49. The device of claim 46 further comprising a delivery string to facilitate deployment of the device at the septal defect.

50. The device of claim 46 wherein said proximal and distal anchor members are collapsible for deployment or removal.

51. The device of claim 50 wherein the proximal and distal anchor members are generally foldable.

52. The device of claim 51 wherein each anchor member includes two elements separated by an elastic hinge.

53. The device of claim 46 wherein a delivery string is attached to the proximal anchor member at a generally central location on the proximal anchor member.

54. The device of claim 46 wherein said removal string is usable for both removal and deployment of the device.

55. The device of claim 46, wherein at least one of said proximal and distal anchor members is configured to move pivotally relative to said flexible connection layer.

56. An apparatus for closing a septal defect, comprising:

a delivery system including a sheath having a tip positionable at the defect; and

a septal occluder collapsible for delivery through the sheath for deployment at the septal defect, the septal occluder comprising;

a proximal anchor member, having an outer surface, axial length and a transverse dimension, and the axial length is longer than the transverse dimension, for deployment at a first end of the septal defect;

a distal anchor member having an outer surface for deployment at a second end of said septal defect; and

a flexible connection layer, having a width and a length, fixedly attached to said proximal anchor member along a proximal attachment line and fixedly attached to said distal anchor member along a distal attachment line, said proximal and distal anchor members and said flexible connection layer comprising one or more bioresorbable materials,

wherein the proximal attachment line extends in an axial direction on the outer surface of the proximal anchor member, the distal attachment line extends in an axial direction on the outer surface of the distal anchor member, and at least one of the distal attachment line and proximal attachment line being along the width of the flexible connection layer.

57. The apparatus of claim 56, wherein at least one of said proximal and distal anchor members is configured to move pivotally relative to said flexible connection layer.

58. An apparatus for closing a septal defect, comprising:

a delivery system including a sheath having a tip positionable at the defect; and

a septal occluder collapsible for delivery through the sheath for deployment at the septal defect, the septal occluder comprising;

an elongated proximal anchor member for deployment at a first end of the septal defect;

an elongated distal anchor member for deployment at a second end of said septal defect; and

a flexible layer having a width and a length, said flexible layer being fixedly attached to said proximal anchor member at a first connection location and fixedly attached to said distal anchor member at a second connection location, wherein at least one of the first and second connection locations forms a juncture line along the width of the flexible layer and along a portion of an axial length of the corresponding anchor member and wherein the flexible layer includes filaments disposed along at least a portion of the axial length of the corresponding anchor member.

59. An apparatus for closing a septal defect, comprising:

a delivery system including a sheath having a tip positionable at the defect; and

a septal occluder collapsible for delivery through the sheath for deployment at the septal defect, the septal occluder comprising;

a proximal anchor member having an outer surface, an axial length and a transverse dimension, the axial length being longer than the transverse dimension, for deployment at a first end of the septal defect;

a distal anchor member for deployment proximate a second end of said septal defect;

a flexible connection layer, having a width and a length, fixedly attached to said proximal anchor along a proximal attachment line extending in an axial direction on the outer surface of the proximal anchor member, and fixedly attached to said distal anchor member along a distal attachment line, wherein at least one of the distal attachment line and proximal attachment line being along the width of the flexible connection layer; and

a removal string extending from said proximal anchor member to facilitate collapsing and removal of the occluder from the septal defect into the delivery sheath if desired.

60. The apparatus of claim 59, wherein at least one of said proximal and distal anchor members is configured to move pivotally relative to said flexible connection layer.

61. A septal occluder, comprising:

a proximal anchor member having an outer surface, an axial length and a transverse dimension,

wherein the axial length is larger than the transverse dimension for deployment proximate a first end of a septal defect;

a distal anchor member for deployment proximate a second end of said septal defect; and

a flexible connection layer, having a width and a length, fixedly attached to said proximal anchor member along a proximal attachment line along an axial direction on the outer surface of the proximal anchor member, and fixedly attached to said distal anchor member along a distal attachment line, at least one of the distal attachment line and proximal attachment line being along the width of the flexible connection layer;

said proximal and distal anchor members and said flexible connection layer comprising one or more plastic materials.

62. The septal occluder of claim 61 wherein said proximal and distal anchor members are elongated.

63. The septal occluder of claim 61 wherein said proximal and distal anchor members each have a generally cylindrical shape with rounded ends.

64. The septal occluder of claim 61 wherein a side of each anchor member for contacting a tissue surface is generally flattened to increase surface contact.

65. The septal occluder of claim 61 wherein said proximal and distal anchor members each comprise a cylindrical structure formed by rolling a layer of material.

66. The septal occluder of claim 61 wherein said proximal and distal anchor members are inflatable.

67. The septal occluder of claim 61 wherein said septal occluder is collapsible for passage through a catheter or sheath.

68. The septal occluder of claim 67 wherein said occluder can be collapsed with the proximal and distal anchor members being in a generally aligned, end to end arrangement for passage through a catheter or sheath.

69. The septal occluder of claim 61 wherein said proximal and distal anchor members are collapsible for deployment or removal.

70. The septal occluder of claim 69 wherein the proximal and distal anchor members are generally foldable.

71. The septal occluder of claim 70 wherein each anchor member includes two elements separated by an elastic hinge.

72. The septal occluder of claim 61 further comprising a removal string attached to the septal occluder to facilitate removal of the septal occluder from the septal defect.

73. The septal occluder of claim 72 wherein said removal string is slidingly mounted in said proximal anchor member and attached to said distal anchor member.

74. The septal occluder of claim 72 wherein said removal string is mounted to slide through said proximal anchor member.

75. The septal occluder of claim 72 further comprising a delivery string to facilitate deployment of the septal occluder at the septal defect.

76. The septal occluder of claim 61 wherein said septal occluder is formed from a layer of material having opposite ends rolled to form the proximal and distal anchor members.

77. The septal occluder of claim 61 further comprising a wire connecting said proximal and distal anchor members to provide clamping force to close the defect.

78. The septal occluder of claim 77 wherein said wire has a serpentine configuration.

79. The septal occluder of claim 71 wherein said flexible connection layer comprises a layer of elastomeric material.

80. The septal occluder of claim 61 wherein said flexible connection layer comprises a layer of material made from thrombogenic or inflammatory materials.

81. The septal occluder of claim 61 wherein said flexible connection layer comprises a layer of material that is porous or textured.

82. The septal occluder of claim 61 wherein said flexible connection layer comprises a layer of material that is covered with a biocompatible glue to promote adherence to tissue.

83. The septal occluder of claim 61 wherein said flexible connection layer comprises a layer of material that is covered with growth factors to accelerate tissue ingrowth.

84. The septal occluder of claim 61, wherein at least one of said proximal and distal anchor members is configured to move pivotally relative to said flexible connection layer at least one of the first and second connection locations.