CA2547088A1 - Vascular occlusion methods, systems and devices - Google Patents

Vascular occlusion methods, systems and devices Download PDF

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Publication number
CA2547088A1
CA2547088A1 CA002547088A CA2547088A CA2547088A1 CA 2547088 A1 CA2547088 A1 CA 2547088A1 CA 002547088 A CA002547088 A CA 002547088A CA 2547088 A CA2547088 A CA 2547088A CA 2547088 A1 CA2547088 A1 CA 2547088A1
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CA
Canada
Prior art keywords
occlusion device
vascular
saphenous vein
vessel
occlusion
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Granted
Application number
CA002547088A
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French (fr)
Other versions
CA2547088C (en
Inventor
Dusan Pavcnik
John A. Kaufman
Thomas Osborne
Brian Bates
Umesh Patel
Clay D. Fette
Likang Chin
Chad S. Mcalexander
Bhavin Shah
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Oregon Health Science University
Cook Inc
Cook Biotech Inc
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Individual
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Publication of CA2547088A1 publication Critical patent/CA2547088A1/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00008—Vein tendon strippers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/36—Materials or treatment for tissue regeneration for embolization or occlusion, e.g. vaso-occlusive compositions or devices

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • Medicines Containing Plant Substances (AREA)

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 (71)

1. A method for treating venous dysfunction in a leg of a human, comprising:
providing at least one percutaneous access to a saphenous vein of the leg;
inserting a delivery device into the saphenous vein through the percutaneous access; and delivering an occlusion device to the saphenous vein with the delivery device.
2. A method according to claim 1, wherein the saphenous vein is the greater saphenous vein.
3. A method according to claim 1, wherein the saphenous vein is the lesser saphenous vein.
4. A method according to any one of claims 1-3, wherein the occlusion device is resorbable.
5. A method according to any one of claims 1-4, wherein the occlusion device is collagenous.
6. A method according to any one of claims 1-5, wherein the occlusion device comprises an extracellular matrix material.
7. A method according to claim 6, wherein the extracellular matrix material comprises submucosa, serosa, pericardium, dura mater, peritoneum, or dermal collagen.
8. A method according to claim 5, wherein the occlusion device comprises reconstituted collagen.
9. A method according to any one of claims 1-8, wherein the occlusion device has a length of at least about 10 cm.
10. A method according to any of claims 1-9, wherein the occlusion device is delivered so as to traverse a junction of at least one perforator vein with the saphenous vein.
11. A method according to any of claims 1-10, wherein the occlusion device extends between a first and second surgical opening in the saphenous vein.
12. A method according to any of claims 1-11, wherein the occlusion device has a length of at least about 20 cm.
13. A method according to any of claims 1-12, wherein the occlusion device comprises submucosa.
14. A method according to any of claims 1-13, wherein the occlusion device comprises an elongate body configurable to a first, compressed condition and expandable upon delivery to a second, expanded condition.
15. A method for occluding a vascular vessel, comprising:

providing a first opening and a second opening in the vessel; and positioning an occlusion device in the vessel extending between the first opening and second opening.
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 any of claims 15-21, 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 any one of claims 15-23, 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 any one of claims 15-25, 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 any one of claims 15-28, 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 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 any one of claims 30-33, 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 any one of claims 30-34, 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 any one of claims 30-37, wherein the occluder body comprises a resorbable material.
39. An occlusion device according to any one of claims 30-38, 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 any one of claims 30-42; 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 is 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.
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 or 48, wherein the vascular occlusion device is configured for occlusion of a human greater saphenous vein.
50. A medical kit according to claim 48, wherein the preloaded vascular occlusion device is an occlusion device according to any one of claims 30-42.
51. A medical kit according to claim 47, also comprising an occlusion device.
52. A medical kit according to claim 51, wherein the occlusion device is an occlusion device according to any one of claims 30-42.
53. A medical assembly for delivery of a vascular occlusion device, comprising:
a vascular occlusion device according to any one of claims 30-42;
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.
57. A method for treating a refluxing saphenous vein of a human, comprising:
percutaneously delivering into the greater saphenous vein an occlusion device so as to occlude and prevent reflux through the vein.
58. A method according to claim 57, wherein the occlusion device is an occlusion device according to any of claims 30-42.
59. A method according to claim 57 or 58, 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 any one of claims 57-59, wherein the saphenous vein is the greater saphenous vein.
61. A method according to any one of claims 57-59, 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 occlusion device, the elongate 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, the occlusion device comprising an occluder body sufficiently elongate for positioning within the first venous vessel so as to traverse said junction.
67. An occlusion device according to claim 66, wherein the occluder body comprises a resorbable material.
68. An occlusion device according to claim 66 or 67, wherein the occluder body comprises a collagenous material.
69. An occlusion device according to claim 68, wherein the occluder body comprises an extracellular matrix material.
70. An occlusion device according to claim 69, wherein the extracellular matrix material comprises submucosa, serosa, pericardium, dura mater, peritoneum, or dermal collagen.
71. An occlusion device according to claim 70, wherein the extracellular matrix material comprises submucosa.
CA2547088A 2003-11-28 2004-11-29 Vascular occlusion methods, systems and devices Active CA2547088C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US52579303P 2003-11-28 2003-11-28
US60/525,793 2003-11-28
US55724804P 2004-03-29 2004-03-29
US60/557,248 2004-03-29
PCT/US2004/039840 WO2005053547A2 (en) 2003-11-28 2004-11-29 Vascular occlusion methods, systems and devices

Publications (2)

Publication Number Publication Date
CA2547088A1 true CA2547088A1 (en) 2005-06-16
CA2547088C CA2547088C (en) 2011-10-18

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CA2547088A Active CA2547088C (en) 2003-11-28 2004-11-29 Vascular occlusion methods, systems and devices

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US (1) US9414843B2 (en)
EP (1) EP1686903B1 (en)
JP (1) JP2007528237A (en)
AU (1) AU2004294990B2 (en)
CA (1) CA2547088C (en)
WO (1) WO2005053547A2 (en)

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AU2004294990B2 (en) 2010-11-11
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EP1686903A2 (en) 2006-08-09
JP2007528237A (en) 2007-10-11

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