Soft filament occlusive device delivery system

• US 20040161451A1
• Filed: 12/17/2003
• Published: 08/19/2004
• Est. Priority Date: 12/17/2002
• Status: Abandoned Application

• Current Assignee: Stryker Corporation
• Original Assignee: Concentric Medical, Inc. (Stryker Corporation)
• Inventors: French, Ron, Sepetka, Ivan, Miller, John, Aboytes, Maria, Pierce, Ryan K., Valley, Kirsten
• Application Number:
  US10/739,900
• Publication Number:
  US 20040161451A1
• Time in Patent Office: Days
• US Class Current: 424/443
• CPC Class Codes: A61K 31/765 Polymers containing oxygen
• CPC Class Codes: A61K 31/785 Polymers containing nitrogen
• CPC Class Codes: A61K 49/0409 Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is not a halogenated organic compound
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids

Abstract

A delivery system for placement of implantable occlusive devices allows placement of the devices place at selected treatment sites in the vascular system. Occlusive filaments produced from gel polymers are delivered by apparatus comprising various grippers, engagers, and couplers that are capable of holding onto the often slippery occlusive devices and of releasing and selectively severing them at desired treatment sites within the human body.

Claims

1. An occlusive component delivery system comprising:

at least one occlusive filamentary component comprising at least a polymeric gel; and

a delivery component having an engager comprising a separation region adapted to isolate and to allow dissolution or phase change of an intermediate portion of the occlusive filamentary component and release a distal portion of that occlusive filamentary component.

2. The system of claim 1, wherein the delivery component comprises a generally coaxially arranged inner tubing member and an outer tubing member, the inner tubing member for holding the occlusive filamentary shape, the outer tubing member extending distally past the inner tubing member and having a distal end for sealing against the occlusive filamentary shape and forming a space for passing a solvent or ionic solution to the occlusive filamentary shape and severing the occlusive filamentary shape.

3. The system of claim 2, wherein the at least one occlusive filamentary shape includes at least one region of enhanced solubility for a chosen solvent or of enhanced susceptibility to phase change upon application of a selected ionic solution relative to other portions of the at least one occlusive filamentary shape.

4. The system of claim 3, further comprising radio-opaque markers bracketing the at least one region of enhanced solubility of the at least one occlusive filamentary shape.

5. The system of claim 1, wherein the delivery component comprises an occlusive filamentary shape lumen for holding the occlusive filamentary shape, the occlusive filamentary shape lumen having a wall with a fluid access opening, the delivery component further comprising a fluid lumen for passing a solvent or ionic solution to the occlusive filamentary shape at the fluid access opening and severing the occlusive filamentary shape.

6. The system of claim 1, wherein the delivery component comprises an outer tubing member with a lumen having an open distal end, and an inflatable balloon member, the inflatable balloon member being positionable within the outer tubing member lumen to press the occlusive filamentary shape against the wall of the lumen upon inflation of the balloon and to isolate the lumen proximal of the balloon and to permit introduction of a solvent or ionic solution to the occlusive filamentary shape and severing it.

27. The system of any one of the preceding claims, wherein the one or more occlusive filamentary components comprise hydratable gel.

28. The system of claim 27, wherein the hydratable gel comprises at least one material selected from the group consisting of polyacrylamide, hydrophilic polyacrylonitrile, poly(N-isopropylacrylamine), poly(vinylmethylether), poly(ethylene oxide), poly(vinylalcohol), poly(ethyl (hydroxyethyl) cellulose), poly(2-ethyl oxazoline), polylactide, polyglycolide, poly(lactide-co-glycolide), poly(e-caprolactone), polydiaoxanone, polyanhydride, trimethylene carbonate, poly(β

-hydroxybutyrate), poly(g-ethyl glutamate), poly(DTH-iminocarbonate), poly(bisphenol A iminocarbonate), poly(orthoester), polycyanoacrylate, polyphosphazene, polyethyleneoxide, polyethyleneglycol, polyacrylicacid, polyacrylonitrile, polyvinylacrylate, polyvinylpyrrolidone, polyglycolic-lactic acid, mixtures of acrylamide-allyl glucose copolymers and concanavalin A, their block and random copolymers, and their blends.

29. The system of claim 27, wherein the hydratable gel comprises at least one material selected from the group consisting of collagen, silk, fibrin, gelatin, hyaluron, cellulose, chitin, dextran, casein, albumin, ovalbumin, heparin sulfate, starch, agar, heparin, alginate, fibronectin, fibrin, keratin, pectin, elastin, and their block and random copolymers and their blends.

30. The system of claim 27, wherein the one or more occlusive components comprise one or more bioactive agents.

31. The system of claim 27, wherein the one or more occlusive components comprise one or more radio-opacifiers.

7. An occlusive component delivery system comprising:

at least one occlusive filamentary component comprising at least a polymeric gel, wherein the occlusive filamentary component has a shank with a substantially constant diameter and a distally located filament interference member; and

a delivery component having an engager, wherein the engager comprises an outer tubing member having an interior, female, distally located interference member with a passageway, the passageway having a size sufficient to allow the shank of the occlusive filamentary shape to freely slide therethrough but not the filament interference member, but the passageway allowing the passage of the filament interference member under a selected hydraulic pressure.

8. The system of claim 7, wherein the distally located filament interference member comprises a widened region of the occlusive filamentary shape.

9. The system of claim 7, wherein the distally located filament interference member comprises at least one added band.

10. The system of claim 7, wherein the distally located filament interference member comprises a knot in the occlusive filamentary shape.

11. The system of claim 7, wherein the distally located filament interference member comprises a helically wound wire or ribbon.

12. The system of claim 11, wherein the a helically wound wire or ribbon is radio-opaque.

13. The system of claim 7, wherein the distally located filament interference member comprises a spherical member.

14. The system of claim 7, wherein the distally located interference member comprises a widened region of the occlusive filamentary shape having a narrowed diameter just proximal of the widened region, the widened region having a size and shape allowing a pressure to force the widened region against the female interference member and a severing of the occlusive filamentary shape at the narrowed diameter by pulling upon the proximal end of the occlusive filamentary shape.

15. An occlusive component delivery system comprising:

at least one occlusive filamentary component comprising at least a polymeric gel, wherein the occlusive filamentary component has a diameter; and

a delivery component having an engager, wherein the engager comprises a tubing member having an interior lumen sized to fit over and to grasp the occlusive filamentary shape but to allow passage of the occlusive filamentary shape upon application of a selected hydraulic pressure.

16. The system of claim 16, wherein the distal end of the engager comprises an interior lumen having an inner diameter larger than an adjacent diameter.

17. The system of claim 16, wherein the distal end of the engager comprises an interior lumen having an inner diameter smaller than an adjacent diameter.

18. An occlusive component delivery system comprising:

at least one occlusive filamentary component comprising at least a polymeric gel; and

a delivery component having an engager, wherein the delivery component comprises an outer tubing member with a lumen having an open distal end and the engager comprises a proximally located pusher member and a distally located interwoven self-expanding tubular member adapted to grasp the occlusive filamentary shape when the self-expanding tubular member is situated within the outer tubing member lumen and to self-expand when the self-expanding tubular member is pushed outside the outer tubing member lumen by the pusher.

19. The system of claim 19, wherein the interwoven self-expanding tubular member comprises a metal or alloy.

20. The system of claim 19, wherein the interwoven self-expanding tubular member comprises a superelastic alloy.

21. The system of claim 19, wherein the interwoven self-expanding tubular member comprises nitinol.

22. An occlusive component delivery system comprising:

at least one occlusive filamentary component comprising at least a polymeric gel; and

a delivery component having an engager, wherein the delivery component comprises a tubing member with a lumen having a distal end and the occlusive filamentary component is situated within the tubing member lumen and is adapted to be pushed outside of tubing member lumen by application of hydraulic pressure to a proximal end of the tubing member.

23. The system of claim 22, wherein the delivery component tubing member further comprises a distally located, duck-bill distendible valve adapted to allow the occlusive filamentary shape to pass outside of the tubing member lumen by application of hydraulic pressure to the proximal end of the tubing member.

24. An occlusive component delivery system comprising:

at least one occlusive filamentary component comprising at least a polymeric gel; and

a delivery component having an engager and a delivery lumen, wherein the engager comprises an expandable member disposed to compress and break the occlusive filamentary component when said occlusive filamentary component is present in the delivery lumen.

25. The system of claim 24, wherein the engager comprises an inflatable balloon disposed in said delivery lumen of the delivery component.

26. The system of claim 24, wherein the engager comprises an inflatable cuff formed over an inner surface of the delivery lumen.