Vascular occlusion methods, systems and devices

• US 9,414,843 B2
• Filed: 05/26/2006
• Issued: 08/16/2016
• Est. Priority Date: 11/28/2003
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated), Oregon Health & Science University
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated), Cook Medical Incorporated (Cook Group Incorporated), Oregon Health & Science University
• Inventors: Pavcnik, Dusan, Kaufman, John A., Osborne, Thomas, Bates, Brian, Patel, Umesh, Fette, Clay D., Chin, Likang, McAlexander, Chad S., Shah, Bhavin
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): SIMPSON, SARAH A
• Application Number:
  US11/442,687
• Publication Number:
  US 20070166345A1
• Time in Patent Office: 3,735 Days
• Field of Search: 606/194, 606/184, 606/108, 424/423
• US Class Current: 1/1
• 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 artificial blood vessels A61L27/507

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 occluding a venous vessel having an inside wall, comprising:

providing a delivery device including a first sheath having a lumen and a second sheath having a lumen, with the second sheath received in the lumen of the first sheath;

providing an occlusion device positioned in the delivery device, the occlusion device including only a single anchoring member configured to expand to forcibly contact the inside wall of the venous vessel and an elongate occluding body extending away from the anchoring member, wherein the anchoring member comprises an expandable sponge body anchoring member, wherein the expandable sponge body anchoring member resides outside of the second sheath and within the lumen of the first sheath, and wherein the elongate occluding body resides within the lumen of the second sheath;

accessing the venous vessel through an access point;

inserting the delivery device into the venous vessel through said access point;

advancing the delivery device through the venous vessel away from the access point;

deploying the sponge body anchoring member out of the lumen of the first sheath and into the venous vessel, wherein the sponge body anchoring member expands to forcibly contact the inside wall of the venous vessel so as to become anchored in the venous vessel and to fill the lumen of the venous vessel with the sponge body anchoring member at a location spaced from said access point; and

removing the delivery device from the venous vessel through said access point, wherein the anchoring member inhibits migration of the elongate occluding body in the venous vessel during said removing such that the elongate occluding body is drawn from the lumen of the second sheath to remain implanted in the venous vessel along an elongate stretch of the venous vessel occurring between said anchoring member and the access point, with the elongate occluding body occluding the flow of blood through said venous vessel along said elongate stretch.

2. The method according to claim 1, wherein the elongate occluding body remains implanted within the venous vessel traversing at least one junction between said venous vessel and a second venous vessel.

3. The method according to claim 2, wherein the second venous vessel is a perforator or communicator vessel.

4. The method according to claim 3, wherein said venous vessel is a superficial venous vessel.

5. The method according to claim 4, wherein said venous vessel is a saphenous vein.

6. The method according to claim 1, wherein said elongate occluding body comprises a remodelable material derived from a collagenous tissue source.

7. The method according to claim 1, wherein said elongate occluding body comprises an expandable porous material.

8. The method according to claim 7, wherein said expandable porous material comprises an extracellular matrix material.

9. The method according to claim 1, wherein said elongate occluding body has a length of at least about 10 cm.

10. The method according to claim 1, wherein said elongate occluding body has a length of at least about 20 cm.

11. The method according to claim 1, wherein said expandable sponge body anchoring member comprises a collagenous material.

12. The method according to claim 11, wherein said collagenous material comprises an extracellular matrix material.

13. The method according to claim 1, wherein said expandable sponge body anchoring member and said elongate occluding body are integrally formed with one another.

14. The method according to claim 1, wherein said expandable sponge body anchoring member comprises a resorbable material.

15. The method according to claim 1, wherein said expandable sponge body anchoring member and said elongate occluding body are separate pieces attached to one another.

16. The method according to claim 1, wherein while said occlusion device is positioned in said delivery device, the expandable sponge body anchoring member has an outer diameter greater than the diameter of the lumen of the second sheath.

17. The method according to claim 1, wherein said elongate occluding body is of sufficient length to extend from said anchoring member to said access point, and wherein the method also includes trimming said elongate occluding body from said access point.

24. The method of claim 15, wherein:

said delivery device includes a first sheath providing said lumen as a first lumen and a second sheath providing a second lumen, with the second sheath received in the first sheath; and

while said occlusion device is positioned in said delivery device, the anchoring member resides outside of the second sheath and within the first lumen, and the elongate occluding body resides within the second lumen.

18. A method for occluding a venous vessel having an inside wall, comprising:

providing a delivery device having a lumen;

providing an occlusion device positioned in the delivery device lumen, the occlusion device having a length of at least about 10 cm and including only a single anchoring member configured to expand to forcibly contact the inside wall of the venous vessel and an elongate occluding body extending away from the anchoring member, the anchoring member and the elongate occluding body comprising the same material, and the anchoring member and the elongate occluding body both being fully received within the delivery device lumen;

accessing the venous vessel through an access point;

inserting the delivery device into the venous vessel through said access point;

advancing the delivery device through the venous vessel away from the access point with the anchoring member and the elongate occluding body both being fully received within the delivery device lumen;

deploying the anchoring member out of the lumen of the delivery device and into the venous vessel, wherein the anchoring member expands to forcibly contact the inside wall of the venous vessel so as to become anchored in the venous vessel at a location spaced from said access point; and

removing the delivery device from the venous vessel through said access point, wherein the anchoring member inhibits migration of the elongate occluding body in the venous vessel during said removing such that the elongate occluding body is drawn from the lumen of the delivery device to remain implanted in the venous vessel along an elongate stretch of the venous vessel occurring between said anchoring member and the access point, with the elongate occluding body occluding the flow of blood through said venous vessel along said elongate stretch.

19. The method of 18, wherein the anchoring member and the elongate occluding body each comprise an extracellular matrix material.

20. The method of 19, wherein the anchoring member comprises an extracellular matrix sponge or foam material.

21. The method of 18, wherein the elongate occluding body and the anchoring member are integrally formed.

22. The method of 18, wherein the elongate occluding body and the anchoring member are formed as separate pieces and attached to one another.

23. The method of 18, wherein the anchoring member comprises an expandable porous material.

25. A method for occluding a venous vessel having an inside wall, comprising:

providing a delivery device having a lumen;

providing an occlusion device positioned in the delivery device lumen, the occlusion device including only a single anchoring member configured to expand to forcibly contact the inside wall of the venous vessel and an elongate occluding body extending away from the anchoring member, the anchoring member comprising an extracellular matrix sponge material, and the anchoring member and elongate occluding body both being fully received within the lumen of the delivery device;

accessing the venous vessel through an access point;

inserting the delivery device into the venous vessel through said access point;

advancing the delivery device through the venous vessel away from the access point with the anchoring member and elongate occluding body both fully received within the lumen of the delivery device;

deploying the anchoring member out of the lumen of the delivery device and into the venous vessel, wherein the anchoring member expands to forcibly contact the inside wall of the venous vessel so as to become anchored in the venous vessel and fill the venous vessel with the sponge material at a location spaced from said access point; and

removing the delivery device from the venous vessel through said access point, wherein the anchoring member inhibits migration of the elongate occluding body in the venous vessel during said removing such that the elongate occluding body is drawn from the lumen of the delivery device to remain implanted in the venous vessel along an elongate stretch of the venous vessel occurring between said anchoring member and the access point, with the elongate occluding body occluding the flow of blood through said venous vessel along said elongate stretch.

31. The method of claim 25, wherein:

said delivery device includes a first sheath providing said lumen as a first lumen and a second sheath providing a second lumen, with the second sheath received in the first sheath; and

while said occlusion device is positioned in said delivery device, the anchoring member resides outside of the second sheath and within the first lumen, and the elongate occluding body resides within the second lumen.

26. The method of 25, wherein the occlusion device has a length of at least about 10 cm.

27. The method of 25, wherein the elongate occluding body comprises an extracellular matrix material.

28. The method of 27, wherein the elongate occluding body and the anchoring member are integrally formed.

29. The method of 27, wherein the elongate occluding body and the anchoring member are formed as separate pieces and attached to one another.

30. The method of 25, wherein the extracellular matrix sponge material is dried in a radially-expandable configuration.