Occlusive implant and methods for hollow anatomical structure

• US 20070248640A1
• Filed: 04/20/2006
• Published: 10/25/2007
• Est. Priority Date: 04/20/2006
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Karabey, Halil, Mirizzi, Michael, Prestezog, Anna
• Granted Patent: US 9,017,361 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• 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 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/1205 Introduction devices

Abstract

Apparatus and methods for treating a hollow anatomical structure comprises an implant sized for insertion into a hollow anatomical structure. The implant comprises a plurality of loose, bulked fibers. The fibers are formed from one or more bioabsorbable materials. Upon implantation, the apparatus causes a partial occlusion of the hollow anatomical structure, followed by a complete or substantially complete occlusion.

Claims

1. A method of treating a hollow anatomical structure, said method comprising:

inserting into said hollow anatomical structure an implant comprising a plurality of bulked fibers, said fibers formed from one or more bioabsorbable materials;

with said implant, causing a partial occlusion of said hollow anatomical structure; and

with said implant, causing a subsequent, substantially complete occlusion of said hollow anatomical structure.

2. The method of claim 1, wherein said hollow anatomical structure comprises a blood vessel.

3. The method of claim 1, wherein said hollow anatomical structure comprises a varicose vein.

4. The method of claim 2, wherein causing an initial occlusion of said hollow anatomical structure comprises reducing blood flow by 10%-90%.

5. The method of claim 2, wherein causing an initial occlusion of said hollow anatomical structure comprises reducing blood flow by 20%-80%.

6. The method of claim 2, wherein causing an initial occlusion of said hollow anatomical structure comprises reducing blood flow by 25%-75%.

7. The method of claim 1, wherein said implant comprises a plurality of loose, bulked fibers.

35. The method of claim 1, wherein said hollow anatomical structure comprises a blood vessel.

36. The method of claim 1, wherein said hollow anatomical structure comprises a varicose vein.

37. The method of claim 1, wherein said implant comprises a plurality of loose, bulked fibers.

8. A method of reducing the patency of a blood vessel, said method comprising:

inserting into said blood vessel an scaffold comprising a plurality of tortuous fibers, said fibers formed from one or more bioabsorbable materials;

with said scaffold, causing a partial occlusion of said blood vessel; and

with said scaffold, causing a subsequent, substantially complete occlusion of said blood vessel.

9. The method of claim 8, wherein said fibers of said scaffold are non-knit.

10. The method of claim 8, wherein said fibers of said scaffold are crimped.

11. The method of claim 8, wherein said fibers of said scaffold are textured.

12. The method of claim 8, wherein inserting said scaffold comprises substantially spanning a lumen of said blood vessel with said fibers.

13. The method of claim 8, further comprising absorbing said fibers into the body of a patient.

14. A method of inhibiting migration of a bioabsorbable fibrous scaffold inserted within a hollow anatomical structure, said method comprising:

permitting biological fluid flow through said scaffold; and

gradually causing a substantially complete blockage of biological fluid flow through said scaffold.

15. The method of claim 14, wherein said hollow anatomical structure comprises a blood vessel, and permitting biological fluid flow through said scaffold comprises permitting antegrade blood flow through said scaffold.

16. The method of claim 15, wherein causing a substantially complete blockage of biological fluid flow through said scaffold comprises blocking antegrade blood flow through said scaffold.

17. The method of claim 14, wherein said inserted scaffold comprises a mass of bioabsorbable fibers which span a lumen of said hollow anatomical structure, and permitting fluid flow through said scaffold comprises permitting fluid flow through said fibers.

18. The method of claim 14, wherein causing blockage of fluid flow comprises causing tissue ingrowth into said scaffold.

19. A method of reducing blood flow through a blood vessel, said method comprising:

providing an implant comprising a plurality of loose bioabsorbable fibers that extend generally longitudinally and form a number of bends along the length thereof;

inserting said implant into said blood vessel;

spanning a cross-section of said blood vessel with said bioabsorbable fibers;

permitting blood flow between said fibers and past said implant; and

subsequently substantially blocking blood flow between said fibers.

20. The method of claim 19, wherein said blood vessel comprises a varicose vein.

21. The method of claim 20, wherein causing an initial occlusion of said blood vessel comprises reducing blood flow by 10%-90%.

22. The method of claim 20, wherein causing an initial occlusion of said blood vessel comprises reducing blood flow by 20%-80%.

23. The method of claim 20, wherein causing an initial occlusion of said blood vessel comprises reducing blood flow by 25%-75%.

24. A method of treating a hollow anatomical structure, said method comprising:

inserting into said hollow anatomical structure an implant comprising a plurality of crimped fibers, said fibers formed from one or more bioabsorbable materials;

with said implant, causing a partial occlusion of said hollow anatomical structure; and

with said implant, causing a subsequent, substantially complete occlusion of said hollow anatomical structure.

25. The method of claim 24, wherein said hollow anatomical structure comprises a blood vessel.

26. The method of claim 24, wherein said hollow anatomical structure comprises a varicose vein.

27. The method of claim 24, further comprising irritating a wall of the hollow anatomical structure near an insertion site of said implant.

28. The method of claim 27, wherein said irritating comprises irritating said wall with a side of said implant.

29. The method of claim 27, wherein said irritating comprises at least partially denuding an endothelial layer of said wall.

30. A method of treating a hollow anatomical structure, said method comprising:

inserting into said hollow anatomical structure an implant comprising a plurality of textured fibers, said fibers formed from one or more bioabsorbable materials;

providing one or more fluid flow paths through said inserted implant;

gradually causing blockage of substantially all of said flow paths.

31. The method of claim 30, further comprising causing a postoperative, substantially complete occlusion of said hollow anatomical structure with said implant.

32. The method of claim 30, wherein said hollow anatomical structure comprises a blood vessel.

33. The method of claim 30, wherein said hollow anatomical structure comprises a varicose vein.

34. A method of treating a hollow anatomical structure, said method comprising:

inserting into said hollow anatomical structure an implant comprising a plurality of bulked fibers, said fibers formed from one or more bioabsorbable materials;

with said implant, causing a partial occlusion of said hollow anatomical structure; and

with said implant, causing a subsequent, more complete occlusion of said hollow anatomical structure.

38. Apparatus for treating a hollow anatomical structure, said apparatus comprising:

an implant sized for insertion into said hollow anatomical structure, said implant comprising a plurality of crimped fibers, said fibers formed from one or more bioabsorbable materials;

said implant extending generally longitudinally from a first end thereof to a second end, said implant forming one or more fluid flow paths between said fibers and extending from said first end to said second end.

39. The apparatus of claim 38, wherein said flow paths are closeable by clotting and/or tissue ingrowth upon implantation of said implant in said hollow anatomical structure.

40. The apparatus of claim 38, wherein said flow paths extend between said fibers.

41. The apparatus of claim 38, wherein said flow paths extend between said fibers along substantially the entire length of said implant.

42. The apparatus of claim 38, wherein said implant has an outer surface which is sufficiently abrasive to irritate a wall of said hollow anatomical structure to thereby encourage tissue ingrowth.

43. The apparatus of claim 42, wherein said abrasive outer surface is formed by said fibers.