Systems and methods for intraluminal delivery of occlusive elements

• US 20050283182A1
• Filed: 06/21/2004
• Published: 12/22/2005
• Est. Priority Date: 06/21/2004
• Status: Abandoned Application

• Current Assignee: Stryker Corporation
• Original Assignee: Concentric Medical, Inc. (Stryker Corporation)
• Inventors: Vu, Emily, Pierce, Ryan K., French, Ronald
• Application Number:
  US10/873,408
• Publication Number:
  US 20050283182A1
• 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 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device

Abstract

The present invention advantageously provides improved systems and methods for intraluminal delivery of implantable occlusive elements, particularly hydratable polymeric filaments. In particular, the systems and methods of the present invention minimize or avoid clumping or clogging a delivery catheter. This is accomplished by utilization of a reinforcing member or sheath that provides an advancing axial force along or over a length of the occlusive element. When the reinforcing member or sheath is pulled in a proximal direction, the occlusive element is advanced to a target site, which may comprise an aneurysm, vasculature of a tumor, arterio-venous malformations, fistulas, or burst blood vessels.

Claims

1. A method for intraluminal delivery of an occlusive element comprising:

positioning a delivery sheath in a body lumen, the sheath having at least an insertion lumen therethrough and containing at least one occlusive element and a reinforcing member coupled to the occlusive element along a length thereof;

pulling the reinforcing member in a proximal direction; and

advancing the occlusive element to a target site.

2. The method of claim 1, wherein the reinforcing member provides an advancing axial force along a length of the occlusive element.

3. The method of claim 1, wherein pulling comprises pulling the reinforcing member in a proximal direction over an outside surface of the delivery sheath.

4. The method of claim 1, wherein pulling comprises pulling the reinforcing member in a proximal direction through a return lumen of the delivery sheath.

5. The method of claim 1, wherein pulling further comprises detaching the reinforcing member from the occlusive element at a distal end of the insertion lumen so as to advance the occlusive element distally of the delivery sheath.

6. The method of claim 1, wherein the body lumen comprises a blood vessel.

7. The method of claim 1, wherein the target site comprises an aneurysm.

8. The method of claim 1, wherein the target site comprises vasculature of a tumor.

9. The method of claim 1, wherein the occlusive element comprises a polymeric filament.

10. The method of claim 9, further comprising hydrating the filament prior to advancing the occlusive element to the target site.

11. The method of claim 1, further comprising retracting the occlusive element through the insertion lumen.

54. A kit comprising:

an occlusive element delivery system; and

instructions to use the system for intraluminal delivery of the occlusive element according to claim 1 or 29.

12. A system for intraluminal delivery of an occlusive element comprising:

a delivery sheath having at least an insertion lumen and return lumen therethrough;

at least one occlusive element slidably received within the insertion lumen;

at least one reinforcing member coupled to the occlusive element along a length thereof and slidably received within both the insertion and return lumens.

13. The system of claim 12, wherein the insertion lumen and return lumen are concentric.

15. The system of claim 12 or 14, wherein the reinforcing member provides an axial force along a length of the occlusive element.

16. The system of claim 12 or 14, wherein the reinforcing member is detachable from the occlusive element at a distal end of the insertion lumen so as to advance the occlusive element distally of the delivery sheath.

17. The system of claim 12 or 14, further comprising an opening in a distal wall of the insertion lumen.

18. The system of claim 12 or 14, wherein a length of the reinforcing member is at least twice the length of the delivery sheath.

19. The system of claim 12 or 14, wherein the reinforcing member comprises nylon, polyurethane, polyimide, polyester, polypropylene, polyethylene, silk, PTFE (polytetrafluoroethylene), ePTFE (expanded polytetrafluoroethylene), PET (polyethyleneterephthalate), CRISTAMID®

, GRILAMID®

, PEBAX®

materials.

20. The system of claim 12 or 14, wherein the reinforcing member is centrally embedded within the occlusive element.

21. The system of claim 12 or 14, wherein the reinforcing member is offset from a central axis of the occlusive element.

22. The system of claim 12 or 14, wherein the occlusive element comprises a filament.

25. The system of claim 12 or 14, further comprising a core member embedded along a length of the occlusive element.

26. The system of claim 25, wherein the core member comprises metal or polymer material.

27. The system of claim 12 or 14, further comprising a catheter which receives the delivery sheath.

28. The system of claim 27, wherein the delivery sheath and catheter form an integrated unit.

14. A system for intraluminal delivery of an occlusive element comprising:

a delivery sheath having at least an insertion lumen therethrough;

at least one occlusive element slidably received within the insertion lumen;

at least one reinforcing member coupled to the occlusive element along a length thereof and disposed over an outside surface of the delivery sheath.

23. The system of claim 23, wherein the filament is hydratable.

24. The system of claim 23, wherein the filament comprises a polymeric gel.

29. A method for intraluminal delivery of an occlusive element comprising:

positioning a delivery catheter in a body lumen, the catheter having at least an insertion lumen and return lumen therethrough and containing at least one occlusive element and a reinforcing sheath encompassing at least a portion of the occlusive element along a length thereof;

pulling the reinforcing sheath in a proximal direction through the return lumen; and

advancing the occlusive element to a target site.

30. The method of claim 29, wherein the reinforcing sheath provides an advancing shear force to an outside surface of the occlusive element along a length thereof.

31. The method of claim 29, wherein pulling further comprises inverting the reinforcing sheath at a distal end of the insertion lumen so as to advance the occlusive element distally of the delivery catheter.

32. The method of claim 29, wherein the body lumen comprises a blood vessel.

33. The method of claim 29, wherein the target site comprises an aneurysm.

34. The method of claim 29, wherein the target site comprises vasculature of a tumor.

35. The method of claim 29, wherein the occlusive element comprises a filament.

36. The method of claim 35, further comprising hydrating the filament prior to advancing the occlusive element to the target site.

37. The method of claim 35, wherein the filament comprises a polymeric gel.

38. The method of claim 29, further comprising retracting the occlusive element through the insertion lumen.

39. A system for intraluminal delivery of an occlusive element comprising:

a delivery catheter having at least an insertion lumen and return lumen therethrough;

at least one occlusive element slidably received within the insertion lumen;

at least one reinforcing sheath encompassing the occlusive element along a length thereof and slidably received within both the insertion and return lumens.

40. The system of claim 39, wherein the reinforcing sheath provides a shear force to an outside surface of the occlusive element along a length thereof.

41. The system of claim 39, wherein the reinforcing sheath is invertable at a distal end of the insertion lumen so as to advance the occlusive element distally of the delivery catheter.

42. The system of claim 39, wherein the reinforcing sheath has a longitudinal opening along a length thereof.

43. The system of claim 39, wherein the reinforcing sheath comprises a circumferential arc in a range from 270 degrees to 340 degrees.

44. The system of claim 39, wherein a length of the reinforcing sheath is at least twice a length of the delivery catheter.

45. The system of claim 39, wherein the reinforcing sheath comprises nylon, polyurethane, polyimide, polyester, polypropylene, polyethylene, silk, PTFE (polytetrafluoroethylene), ePTFE (expanded polytetrafluoroethylene), PET (polyethyleneterephthalate), CRISTAMID®

, GRILAMID®

, PEBAX®

materials.

46. The system of claim 39, wherein the insertion lumen and return lumen are concentric.

47. The system of claim 46, wherein the insertion lumen and return lumen have different lengths.

48. The system of claim 47, wherein walls of the insertion lumen and return lumen are bridged to form an integrated unit.

49. The system of claim 39, wherein the occlusive element comprises a filament.

50. The system of claim 49, wherein the filament is hydratable.

51. The system of claim 49, wherein the filament comprises a polymeric gel.

52. The system of claim 39, further comprising a core member embedded along a length of the occlusive element.

53. The system of claim 52, wherein the core member comprises metal or polymer material.