Vascular occlusion methods, systems and devices

• US 20070166345A1
• Filed: 05/26/2006
• Published: 07/19/2007
• Est. Priority Date: 11/28/2003
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated), Oregon Health & Science University
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Osborne, Thomas, Pavcnik, Dusan, Shah, Bhavin, Bates, Brian, Fette, Clay, Patel, Umesh, McAlexander, Chad, Kaufman, John, Chin, Likang
• Granted Patent: US 9,414,843 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61B 17/00008 Vein tendon strippers tube strippers A61M1/83
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices

Abstract

Described are devices, methods and systems useful for achieving occlusion of vascular vessels. Percutaneous procedures are used to occlude and obliterate the greater saphenous vein, for example in the treatment of varicose vein condition caused by venous reflux. Certain embodiments encompass the deployment of one or more vascular occlusion devices via a through-and-through percutaneous procedure that leaves the vascular occlusion device or devices in a through-and-through condition.

Claims

1. A method for treating venous reflux in a saphenous vein of a patient, comprising:

providing an elongate bioremodelable occlusion device;

implanting the elongate bioremodelable occlusion device within a saphenous vein of a patient so as to obliterate a substantial segment of the saphenous vein to reduce or eliminate venous reflux through the saphenous vein segment.

2. The method of claim 1, wherein said implanting comprises deploying the elongate occlusion device within the saphenous vein through the lumen of a percutaneously placed cannulated device.

3. The method of claim 1, wherein the elongate bioremodelable occlusion device is at least 10 cm in length.

4. The method of claim 1, wherein the bioremodelable occlusion device comprises a collagenous material.

5. The method of claim 4, wherein the collagenous material comprises an extracellular matrix material.

6. The method of claim 5, wherein the extracellular matrix material comprises submucosa, serosa, pericardium, dura mater, peritoneum, or dermal collagen.

7. The method of claim 5, wherein the extracellular matrix material comprises porcine submucosa.

8. A medical product for occluding a vascular vessel of a patient, comprising:

a bioremodelable material configured for deployment within a vascular vessel of a patient so as to cause occlusion of the vascular vessel and reduce or prevent the reflux of blood through a segment of the vascular vessel.

9. The medical product of claim 8, wherein the bioremodelable material is configured to move between a contracted state and an expanded state.

10. The medical product of claim 9, wherein the bioremodelable material comprises a porous sponge form material.

11. The medical product of claim 10, wherein the porous sponge form material comprises an extracellular matrix material.

12. The medical product of claim 11, wherein the extracellular matrix material comprises mammalian submucosa.

13. The medical product of claim 8, wherein the bioremodelable material includes at least one anchor.

14. The medical product of claim 13, wherein the at least one anchor comprises a self expanding stent attached to the bioremodelable material.

15. A method for occluding a vascular vessel, comprising:

providing a first opening and a second opening in the vessel;

positioning an occlusion device in the vessel extending between the first opening and second opening; and

anchoring the occlusion device so as to prevent migration of the device within the vessel.

16. A method according to claim 15, wherein the vascular vessel is a vein.

17. A method according to claim 16, wherein the vein is in a human leg.

18. A method according to claim 17, wherein the vein is a saphenous vein.

19. A method according to claim 18, wherein the saphenous vein is a greater saphenous vein.

20. A method according to claim 18, wherein the saphenous vein is a lesser saphenous vein.

21. A method according to claim 18, wherein the saphenous vein includes both the greater and lesser saphenous vein.

22. A method according to claim 15, wherein the first and second openings are created percutaneously.

23. A method according to claim 22, wherein the first opening is created by percutaneous entry, and the second opening is created by an elongate puncture device passed through the vascular vessel from the first opening to a position spaced from the first opening.

24. A method according to claim 15, wherein the occlusion device comprises a resorbable material.

25. A method according to claim 24, wherein the occlusion device comprises a collagenous material.

26. A method according to claim 15, wherein the occlusion device comprises an extracellular matrix material.

27. A method according to claim 26, wherein the extracellular matrix material comprises submucosa, serosa, pericardium, dura mater, peritoneum, or dermal collagen.

28. A method according to claim 25, wherein the occlusion device comprises reconstituted collagen.

29. A method according to claim 15, wherein the occlusion device has a length of at least about 10 cm.

30. An occlusion device useful for occluding a vascular vessel of a human, comprising an occluder body having a length of at least about 10 cm, the occluder body comprising a bioremodelable material configured for percutaneous delivery into the vascular vessel so as to cause occlusion of the vascular vessel.

31. An occlusion device according to claim 30, wherein the occluder body has a length of at least about 20 cm.

32. An occlusion device according to claim 30, wherein the occluder body has a length of at least about 30 cm.

33. An occlusion device according to claim 30, wherein the occluder body has a length of at least about 40 cm.

34. An occlusion device according to claim 30, wherein the occluder body comprises an elongate core body and at least one thrombogenic element extending from the elongate core body.

35. An occlusion device according to claim 30, wherein the occluder body is configured in a first, compressed condition and is expandable upon delivery to a second, expanded condition.

36. An occlusion device according to claim 35, wherein the occluder body in said first, compressed condition includes at least one rolled or folded portion.

37. An occlusion device according to claim 36, wherein the occluder body in said first, compressed condition includes a plurality of folds.

38. An occlusion device according to claim 30, wherein the occluder body comprises one or more anchors.

39. An occlusion device according to claim 30, wherein the occluder body comprises a collagenous material.

40. An occlusion device according to claim 39, wherein the occluder body comprises an extracellular matrix material.

41. An occlusion device according to claim 40, wherein the extracellular matrix material comprises submucosa, serosa, pericardium, dura mater, peritoneum, or dermal collagen.

42. An occlusion device according to claim 41, wherein the extracellular matrix material comprises submucosa.

43. A medical kit for vascular occlusion, comprising:

an occlusion device according to claim 30;

and

at least one additional device for percutaneous passage into the vascular vessel.

44. A medical kit according to claim 43, wherein the at least one additional device comprises a delivery device for delivering the occlusion device into the vascular vessel.

45. A medical kit according to claim 44, wherein the delivery device comprises a lumen, and wherein the occlusion device is receivable in and deliverable from the lumen.

50. A medical kit according to claim 48, wherein the preloaded vascular occlusion device is an occlusion device according to claim 30.

52. A medical kit according to claim 51, wherein the occlusion device is an occlusion device according to claim 30.

53. A medical assembly for delivery of a vascular occlusion device, comprising:

a vascular occlusion device according to claim 30;

a delivery device; and

wherein said vascular occlusion device is engaged with said delivery device.

54. A medical assembly according to claim 53, wherein the delivery device comprises a lumen, and wherein the vascular occlusion device is engaged with the delivery device by receipt within the lumen.

55. A medical assembly according to claim 53, wherein the vascular occlusion device is engaged with the delivery device by receipt over the delivery device.

56. A medical assembly according to claim 53, wherein the vascular occlusion device is engaged with the delivery device by attachment at or adjacent to an end of the delivery device.

58. A method according to claim 57, wherein the occlusion device is an occlusion device according to claim 30.

46. A medical kit useful for delivery of a vascular occlusion device, the kit comprising:

an elongate puncture device for passage through and providing percutaneous exit from a vascular vessel;

a cannulated guiding device having a lumen for receiving the elongate puncture device;

a sheath passable over the cannulated guiding device; and

an elongate device passable through the sheath and configured for engagement with the elongate vascular occlusion device to force the occlusion device through the sheath.

47. A medical kit useful for delivery of a vascular occlusion device in a vascular vessel, the kit comprising:

an elongate puncture device for passage through and providing percutaneous exit from a vascular vessel;

a cannulated guiding device having a lumen for receiving the elongate puncture device;

a first sheath passable over the cannulated guiding device; and

a second sheath passable through the first sheath and configured to contain the vascular occlusion device.

48. A medical kit according to claim 47, wherein the second sheath contains a preloaded vascular occlusion device.

49. A medical kit according to claim 47, wherein the vascular occlusion device is configured for occlusion of a human greater saphenous vein.

51. A medical kit according to claim 47, also comprising an occlusion device.

57. A method for treating a refluxing saphenous vein of a human, comprising:

percutaneously locating into the greater saphenous vein a cannulated device having a lumen for slidably receiving an occlusion device;

loading an occlusion device within the lumen of the cannulated device contained within the greater saphenous vein; and

delivering an occlusion device into the greater saphenous vein through the lumen of the cannulated device so as to occlude and prevent reflux through the vein.

59. A method according to claim 57, wherein the occlusion device is delivered so as to traverse at least one junction between a perforator and the saphenous vein.

60. A method according to claim 57, wherein the saphenous vein is the greater saphenous vein.

61. A method according to claim 57, wherein the saphenous vein is the lesser saphenous vein.

62. A method for occluding a first venous vessel, comprising:

providing within the first venous vessel an elongate bioremodelable occlusion device, the elongate bioremodelable occlusion device traversing at least one junction between the first venous vessel and a second venous vessel.

63. A method according to claim 62, wherein the second venous vessel is a perforator or communicator vessel.

64. A method according to claim 63, wherein the first venous vessel is a superficial venous vessel.

65. A method according to claim 64, wherein the first venous vessel is a saphenous vein.

66. An occlusion device useful for occluding a segment of a first venous vessel, the first venous vessel having a junction with a second venous vessel;

wherein the occlusion device comprises an occluder body with sufficient column strength to be pushed through a cannulated device lumen; and

wherein the occlusion device is sufficiently elongate for positioning within the first venous vessel so as to traverse said junction.

67. The device of claim 66, wherein the occlusion device comprises an occluder body received over an internal guide member.

68. The device of claim 67, wherein the occluder body comprises a collagenous material.

69. The device of claim 68, wherein the occluder body comprises an extracellular matrix material.

70. The device of claim 69, wherein the extracellular matrix material comprises submucosa, serosa, pericardium, dura mater, peritoneum, or dermal collagen.

71. The device of claim 70, wherein the extracellular matrix material comprises mammalian submucosa.

72. The device of claim 67, wherein the internal guide member comprises an extracellular matrix material.

73. A method for treating venous dysfunction in a leg of a human, comprising:

providing a percutaneous access to a saphenous vein of the leg near the medial side of the knee or ankle;

inserting a delivery device into the saphenous vein through the percutaneous access;

translating the delivery device within the saphenous vein in a downstream direction toward the heart; and

delivering an occlusion device to the saphenous vein with the delivery device.

74. A method according to claim 73, wherein the percutaneous access is adjacent the medial side of the knee and the saphenous vein is the greater saphenous vein.

75. A method according to claim 73, wherein the percutaneous access is near the medial side of the ankle and the saphenous vein is the lesser saphenous vein.

76. A method according to claim 73, wherein the occlusion device is resorbable.

77. A method according to claim 73, wherein the occlusion device is collagenous.

78. A method according to claim 73, wherein the occlusion device comprises an extracellular matrix material.

79. A method according to claim 78, wherein the extracellular matrix material comprises submucosa, serosa, pericardium, dura mater, peritoneum, or dermal collagen.

80. A method according to claim 77, wherein the occlusion device comprises reconstituted collagen.

81. A method according to claim 73, wherein the occlusion device has a length of at least about 10 cm.

82. A method according to claim 73, wherein the occlusion device is delivered so as to traverse a junction of at least one perforator vein with the saphenous vein.

83. A method according to claim 73, wherein the occlusion device comprises one or more elongate bands of material.

84. A method according to claim 73, wherein the occlusion device has a length of at least about 20 cm.

85. A method according to claim 73, wherein the occlusion device comprises submucosa.

86. A method according to claim 73, wherein the occlusion device comprises an elongate body configurable to a first, compressed condition and expandable upon delivery to a second, expanded condition.

87. A medical product for occluding a vascular segment, comprising:

an occluder body configured to provide biocompatible material of the body spanning and blocking the internal lumen of a vascular vessel when the occluder body is located within the vascular vessel so that the biocompatible material prevents fluid reflux through at least a segment of the vascular vessel.

88. The medical product of claim 87, wherein the biocompatible material comprises a resorbable material.

89. The medical device of claim 88, wherein the biocompatible material comprises an extracellular matrix material.

90. The medical device of claim 89, wherein the extracellular matrix material comprises a sponge form material.

91. The medical device of claim 90, wherein the sponge form material comprises porcine submucosa.

92. The medical product of claim 89, wherein the extracellular matrix material comprises a roll of material.

93. A medical product for occluding a vascular vessel, comprising:

an elongate occluder body;

said elongate occluder body comprising a bioremodelable material that is sufficiently rigid for advancement of the occluder body through a cannulated percutaneous delivery device for deployment in the vascular vessel.

94. The medical product of claim 93, wherein the bioremodelable material comprises a collagenous material.

95. The medical product of claim 94, wherein the collagenous material comprises an extracellular matrix material.

96. The medical product of claim 95, wherein the extracellular matrix material comprises porcine submucosa.