Embolization device and a method of using the same

• US 20040210249A1
• Filed: 11/12/2002
• Published: 10/21/2004
• Est. Priority Date: 11/12/2002
• Status: Active Grant

• Current Assignee: Endologix
• Original Assignee: Thomas J. Fogarty
• Inventors: Drews, Michael J., Modesitt, D. Bruce, Holmgren, Neil, Fogarty, Thomas J., Willis, David B.
• Granted Patent: US 7,481,821 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve

Abstract

Non-expandable space-occupying devices for treating voids within the body are disclosed. The devices can have multiple non-expandable space-occupying elements connected to a flexible leader. Methods of making and using the devices are also disclosed.

Claims

1. A device for filling an abnormal void within the body comprising:

a first flexible leader;

a first non-expandable space-occupying element connected to the first leader at a first length along the first leader; and

a second non-expandable space-occupying element connected to the first leader at a second length along the first leader.

2. The device of claim 1, wherein the first element comprises polymer.

3. The device of claim 2, wherein the polymer comprises polypropylene.

4. The device of claim 3, wherein the second element comprises polypropylene.

5. The device of claim 2, wherein the second element comprises polymer.

6. The device of claim 1, wherein the first element comprises collagen.

7. The device of claim 6, wherein the second element comprises collagen.

8. The device of claim 1, further comprising a radiopaque agent fixed to or integrated with the device.

9. The device of claim 1, further comprising a coating on the device.

10. The device of claim 9, wherein the coating comprises a therapeutic agent and/or a diagnostic agent.

11. The device of claim 9, wherein the coating comprises a thrombogenic material.

12. The device of claim 9, wherein the coating comprises a collagen matrix.

13. The device of claim 9, wherein the coating comprises a metal.

14. The device of claim 13, wherein the metal is gold.

15. The device of claim 9, wherein the coating contains an NSAID.

16. The device of claim 1, further comprising a structural reinforcement supporting the first element.

17. The device of claim 16, wherein the structural reinforcement is a weave.

18. The device of claim 17, wherein the weave comprises polyester.

19. The device of claim 1, wherein the first element is discrete from the first leader, and wherein the second element is discrete from the first leader.

20. The device of claim 19, wherein the first element is slidably connected to the first leader.

21. The device of claim 1, further comprising a first connector connecting the first element to the first leader.

22. The device of claim 21, wherein the first connector is a first ferrule fixed to the first leader.

23. The device of claim 21, wherein the first element is slidably connected to the first leader.

24. The device of claim 21, further comprising a second connector connected to the second element and the first leader.

25. The device of claim 1, wherein the first leader is helical.

26. The device of claim 1, wherein the first leader comprises a first end integrated with the first element.

27. The device of claim 26, further comprising a second leader comprising a first end integrated with the second element.

28. The device of claim 26, wherein the first leader comprises a second end integrated with the second element.

29. The device of claim 28, further comprising a second leader comprising a first end integrated with the second element.

30. The device of claim 1, wherein the first leader comprises a first end attached to the first element to impede removal of the first element from the first leader.

31. The device of claim 30, wherein the first leader comprises a second end attached to the second element to impede removal of the second element from the first leader.

32. The device of claim 31, wherein the first end of the first leader is in the first element, and the second end of the first leader is in the second element.

33. The device of claim 30, wherein the first leader comprises a knot to impede removal of the first element from the first leader.

34. The device of claim 1, further comprising a second flexible leader, wherein the first element is connected to the second leader at a first length along the second leader, and the second element is connected to the second leader at a second length along the second leader.

35. A space-occupying assembly comprising:

The device of claim 1, the device having a maximum outer diameter; and

a catheter having an inner diameter;

wherein the clearance between the maximum outer diameter and the inner diameter is equal to or less than the critical clearance.

36. The assembly of claim 35, wherein the critical clearance is about 80% of the maximum outer diameter.

37. The assembly of claim 35, wherein the critical clearance is about 26% of the maximum outer diameter.

38. The assembly of claim 35, wherein the critical clearance is about 12% of the maximum outer diameter.

65. The device of claim 16, wherein the structural reinforcement is integrated with the first element.

66. The device of claim 16, wherein the structural reinforcement is encased by the first element.

67. The device of claim 16, wherein the structural reinforcement comprises a spiral element.

68. The device of claim 67, wherein the spiral element comprises a continuous wound wire.

69. The device of claim 16, wherein the first element comprises a helical shape, and wherein the structural reinforcement comprises a portion that is parallel to the helical shape.

70. The device of claim 1, wherein the first element is discrete from the first leader, and wherein the second element is discrete from the first leader.

71. The device of claim 70, wherein the first element is slidably connected to the first leader.

72. The device of claim 1, further comprising a second connector connected to the second element and the first leader.

73. The device of claim 1, wherein the first leader is helical.

74. The device of claim 1, wherein the first leader comprises a first end integrated with the first element.

75. The device of claim 74, further comprising a second leader comprising a first end integrated with the second element.

76. The device of claim 74, wherein the first leader comprises a second end integrated with the second element.

77. The device of claim 76, further comprising a second leader comprising a first end integrated with the second element.

78. The device of claim 1, wherein the first leader comprises a first end attached to the first element to impede removal of the first element from the first leader.

79. The device of claim 78, wherein the first leader comprises a second end attached to the second element to impede removal of the second element from the first leader.

80. The device of claim 79, wherein the first end of the first leader is in the first element, and the second end of the first leader is in the second element.

81. The device of claim 78, wherein the first leader comprises a knot.

82. The device of claim 81, wherein the knot impedes removal of the first element from the first leader.

83. The device of claim 1, further comprising a second flexible leader, wherein the first element is connected to the second leader at a first length along the second leader, and the second element is connected to the second leader at a second length along the second leader.

84. The device of claim 1, wherein the first leader comprises a preformed resilient structure.

85. The device of claim 1, wherein the first leader is resilient.

39. A space-occupying device comprising:

a leader comprising a flexible material, and

a space-occupying element connected to the leader, the element comprising a first component and a second component, wherein the first component is secured to the second component.

40. The device of claim 39, further comprising a connector slidably connecting the element to the leader.

41. The device of claim 40, wherein the connector is a ferrule fixed to the leader.

42. The device of claim 39, wherein the element is non-expandable.

43. A space-occupying device comprising:

A space-occupying element comprising a first end comprising a flexible helical segment, wherein when the segment is fully extended, the segment has a cross-sectional width and height, wherein the ratio of cross-sectional width to height is equal to or greater than about 1.5;

1.

44. The device of claim 43, wherein the segment is wound around an axis, and wherein the cross-sectional height is perpendicular to the axis.

45. The device of claim 43, wherein the ratio of cross-sectional width to height is equal to or greater than about 4:

1.

46. The device of claim 45, wherein the element is wound around an axis, and wherein the cross-sectional height is perpendicular to the axis.

47. A space-occupying device comprising:

a first space-occupying element comprising a body and a first male interference-fit piece,

a second space-occupying element comprising a body and a first female interference-fit piece;

and wherein the first male interference-fit piece and the first female interference-fit piece attach to impede removal of the first male interference-fit piece from the first female interference-fit piece.

48. The device of claim 47, further comprising a third space-occupying element comprising a second female interference-fit piece, wherein the second element comprises a second male interference-fit piece, and wherein the second male interference-fit piece and the second female interference-fit piece attach to impede removal of the second male interference-fit piece from the second female interference-fit piece.

49. The device of claim 48, wherein the first male interference-fit piece comprises a poppet, the second male interference-fit piece comprises a poppet, the first female interference-fit piece comprises a socket, and the second female interference-fit piece comprises a socket.

50. The device of claim 49, wherein the first, second, and third space-occupying elements are non-expandable.

51. A vascular embolization device comprising:

a first space-occupying element comprising a body and a first female interference-fit piece,

a second space-occupying element comprising a body and a second female interference-fit piece,

a leader comprising a first male interference-fit piece on a first end and a second male interference-fit piece on a second end;

and wherein the first male interference-fit piece and the first female interference-fit piece attach to impede removal of the first male interference-fit piece from the first female interference-fit piece, and the second male interference-fit piece and the second female interference-fit piece attach to impede removal of the second male interference-fit piece from the second female interference-fit piece.

52. A method for filling an abnormal void within the body, the method comprising:

placing in a void within the body a catheter having a distal exit, the distal exit placed at a treatment site;

passing a space-occupying device through the catheter and distal exit, the space-occupying device having a device volume and comprising a flexible leader, a first non-expandable space-occupying element connected to the leader, and a second non-expandable space-occupying element connected to the leader; and

deploying the device into the treatment site.

53. The method of claim 52, further comprising selecting a device volume wherein the device volume is large enough to substantially fill the treatment site, and selecting a device volume wherein the device volume is small enough to prevent substantial alteration of the natural fluid flow through an adjacent element.

54. The method of claim 53, wherein the adjacent element is a vascular prosthesis.

55. The method of claim 52, further comprising placing a vascular prosthesis at the treatment site.

56. The method of claim 55, wherein deploying the device into the treatment site comprises deploying the device into the volume between a vascular wall at the treatment site and the vascular prosthesis.

57. The method of claim 52, wherein the device further comprises a radiopaque agent, and wherein the method further comprises visualizing the location of the device after passing the device through the distal exit.

58. The method of claim 52, further comprising releasing a therapeutic and/or diagnostic agent and releasing at the treatment site.

59. The method of claim 52, wherein passing and deploying the device further comprises pushing the device with a driver.

60. The method of claim 59, wherein the driver comprises a ratcheting mechanism contacting the device, wherein the ratcheting mechanism impedes retraction of the device from the catheter.

61. The method of claim 59, wherein the driver comprises a slider, the slider having an outer diameter, the catheter having an inner diameter, wherein the outer diameter of the slider is smaller than the inner diameter of the catheter, and wherein the slider abuts a first end of the device and delivers a force to the device.

62. The method of claim 52, further comprising removing debris from the treatment site before deploying the device.

63. The method of claim 62 wherein removing debris comprises applying a lytic agent to the treatment site.

64. The method of claim 52, further comprising delivering the space-occupying device from a tube to the catheter, wherein a connector connects the tube and the catheter, and wherein the connector releasably fixes the catheter to the tube.

86. A device for filling an abnormal void within the body comprising:

a first flexible leader; and

a space-occupying element connected to the leader, the space-occupying element comprising a first component and a second component, wherein the first component is secured to the second component.

87. The device of claim 86, further comprising a connector slidably connecting the element to the leader.

88. The device of claim 87, wherein the connector is a ferrule fixed to the leader.

89. The device of claim 86, wherein the element is non-expandable.

90. A device for filling an abnormal void within the body comprising:

A space-occupying element comprising a first end comprising a flexible helical segment, wherein when the segment is fully extended, the segment has a cross-sectional width and height, wherein the ratio of cross-sectional width to height is equal to or greater than about 1.5;

1.

91. The device of claim 90, wherein the segment is wound around an axis, and wherein the cross-sectional height is perpendicular to the axis.

92. The device of claim 90, wherein the ratio of cross-sectional width to height is equal to or greater than about 4:

1.

93. The device of claim 92, wherein the element is wound around an axis, and wherein the cross-sectional height is perpendicular to the axis.