Stretch resistant vaso-occlusive coils (II)

• US 6,013,084 A
• Filed: 06/20/1997
• Issued: 01/11/2000
• Est. Priority Date: 06/30/1995
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Inventors: Eder, Joseph C., Teoh, Clifford, Ken, Christopher G. M.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US08/879,408
• Time in Patent Office: 935 Days
• Field of Search: 606/198, 606/192, 606/191, 606/108, 606/1, 623/12
• US Class Current: 606/108
• 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 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12154 having stretch limiting means
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation

Abstract

This is an implantable vaso-occlusive device. It is typically a vaso-occlusive coil comprising a primary helically wound coil which may then be wound into a secondary shape. Central to the invention is the use of a stretch-resisting member extending through the lumen formed, which stretch-resisting member is fixedly attached, directly or indirectly, to the coil in at least two locations. The stretch-resisting member is preferably somewhat loose within the interior of the lumen so to prevent the coil from collapsing, binding, and therefore stiffening during passage of turns through the human body. The coil should bend easily. In some variations of the invention, the stretch-resisting member may be formed into coil tips at the ends of the coil using simple equipment such as soldering irons or the like. The tips are typically of the same diameter as is the coil body itself. This stretch-resisting member is for the primary purpose of preventing stretching of the coil during movement of that coil, e.g., by retrieval or repositioning after deployment. The device may have a self-forming secondary shape made from a pre-formed primary linear helically wound coil, although it need not have the secondary form. Desirably, the coil is extremely flexible and is controllaby released using a severable or mechanical joint such as an electrolytically detachable joint. External fibers may be attached to the device and affixed to the pre-formed linear member to increase thrombogenicity. The extremely flexible variation of the invention may be hydraulically delivered through the lumen of a catheter and is so flexible that it may be retrievably delivered therethrough a flow-directed catheter. The vaso-occlusive member may be also be covered with a fibrous braid. The device is typically introduced into the body through a catheter. The device is passed axially through the catheter sheath and assumes its secondary form upon exiting the catheter.

Claims

1. A vaso-occlusive device comprising:

i. an outer helically wound coil having a primary shape, first end, and a second end, said coil defining a lumen between said first end and second end, the helically wound coil further having a secondary shape different from the primary shape; and

ii. a stretch-resisting member comprising at least one polymeric filament having a first end and a second end, the stretch-resisting member extending through at least a portion of said lumen, said stretch-resisting member not substantially affecting the shape of said coil when said coil is in said secondary shape, and said stretch-resisting member being attached to said coil in at least two locations.

2. The device of claim 1 wherein the stretch-resisting member has been heat-treated in said lumen when said coil is in said secondary.

3. The device of claim 1 wherein the polymeric filament is thermoplastic.

4. The device of claim 1 wherein the polymeric filament is melted onto at least several helical turns of the coil.

5. The device of claim 1 wherein the first end of the polymeric filament is sealed to the first end of the coil to form a cap and the second end of the polymeric filament is sealed to the second end of the coil to form a cap.

6. The device of claim 1 wherein the stretch-resisting member has been secured to said coil when the coil is in the secondary shape.

7. The device of claim 1 comprising a deployment tip attached to at least one of said first end or said second end of said coil.

8. The device of claim 7 wherein said deployment tip comprises a mechanically detachable end adapted to attach to and detach from a pusher.

9. The device of claim 7 wherein said deployment tip comprises an electrolytically detachable end adapted to detach from a pusher by imposition of a current on said pusher.

10. The device of claim 1 wherein said helically wound coil comprises a metal selected from the group consisting of platinum, palladium, rhodium, gold, tungsten, and their alloys.

11. The device of claim 10 wherein said helically wound coil comprises an alloy of platinum and tungsten.

12. The device of claim 1 wherein said helically wound coil comprises an alloy selected from the group consisting of stainless steels and superelastic alloys.

13. The device of claim 12 wherein said helically wound coil comprises a nickel-titanium super-elastic alloy.

14. The device of claim 1 comprising a polymer containing a radio-opaque filler.

15. The device of claim 1 additionally comprising external filamentary material attached to said primary coil.

16. The device of claim 1 wherein the stretch-resisting member comprises a polymeric filament selected from the group consisting of polypropylene, polyethylene terephthalate, nylon, polyethylene, polybutylene, polyglycolic acid, polylactic acid, polytetrafluoroethylene, silk, and collagen.

17. The device of claim 16 wherein said stretch-resisting member comprises polypropylene.

18. The device of claim 17 wherein the stretch-resisting member comprises 10-0 polypropylene sutures.

19. The device of claim 17 wherein the stretch-resisting member comprises 9-0 polypropylene sutures.

20. The device of claim 1 wherein said cap is of the same diameter as said primary coil.

21. The device of claim 1 wherein the helically wound primary coil has a flexibility such that one free centimeter will flex more than about 20°

when held horizontally.

22. The device of claim 1 further comprising, in combination, a flow-directed catheter surrounding at least a portion of said helically wound primary coil.

23. A vaso-occlusive device comprising:

i. an outer helically wound coil having a primary shape, first end, and a second end, said coil defining a lumen between said first end and second end, the helically wound coil further having a secondary shape different from the primary shape; and

ii. a stretch-resisting member comprising at least one polymeric filament having a first end and a second end, the stretch-resisting member extending through at least a portion of said lumen, said stretch-resisting member not substantially affecting the shape of said coil when said coil is in said secondary shape, said stretch-resisting member being attached to said coil in at least two locations, and said stretch-resisting member being fixedly attached to a hook within the lumen of said coil.

24. The device of claim 23 wherein the stretch-resisting member has been heat-treated in said lumen when said coil is in said secondary shape.

25. The device of claim 23 wherein the polymeric filament is thermoplastic.

26. The device of claim 23 wherein the polymeric filament is melted onto at least several helical turns of the coil.

27. The device of claim 23 wherein the first end of the polymeric filament is scaled to the first end of the coil to form a cap and the second end of the polymeric filament is sealed to the second end of the coil to form a cap.

28. The device of claim 23 wherein the stretch-resisting member has been secured to said coil when the coil is in the secondary shape.

29. The device of claim 23 comprising a deployment tip attached to at least one of said first end or said second end of said coil.

30. The device of claim 29 wherein said deployment tip comprises a mechanically detachable end adapted to attach to and detach from a pusher.

31. The device of claim 29 wherein said deployment tip comprises an electrolytically detachable end adapted to detach from a pusher by imposition of a current on said pusher.

32. The device of claim 23 wherein said helically wound coil comprises a metal selected from the group consisting of platinum, palladium, rhodium, gold, tungsten, and their alloys.

33. The device of claim 32 wherein said helically wound coil comprises an alloy of platinum and tungsten.

34. The device of claim 23 wherein said helically wound coil comprises an alloy selected from the group consisting of stainless steels and super-elastic alloys.

35. The device of claim 34 wherein said helically wound coil comprises a nickel-titanium super-elastic alloy.

36. The device of claim 23 comprising a polymer containing a radio-opaque filler.

37. The device of claim 23 additionally comprising external filamentary material attached to said primary coil.

38. The device of claim 23 wherein the stretch-resisting member comprises a polymeric filament selected from the group consisting of polypropylene, polyethylene terephthalate, nylon, polyethylene, polybutylene, polyglycolic acid, polylactic acid, polytetrafluoroethylene, silk, and collagen.

39. The device of claim 38 wherein said stretch-resisting member comprises polypropylene.

40. The device of claim 39 wherein the stretch-resisting member comprises 10-0 polypropylene sutures.

41. The device of claim 40 wherein the stretch-resisting member comprises 9-0 polypropylene sutures.

42. The device of claim 23 wherein said cap is of the same diameter as said primary coil.

43. The device of claim 23 wherein the helically wound primary coil has a flexibility such that one free centimeter will flex more than about 20°

when held horizontally.

44. The device of claim 23 further comprising, in combination, a flow-directed catheter surrounding at least a portion of said helically wound primary coil.