Catheter system for release of embolization coils by hydraulic pressure

• US 6,428,557 B1
• Filed: 09/27/1999
• Issued: 08/06/2002
• Est. Priority Date: 12/16/1998
• Status: Expired due to Fees

• Current Assignee: Arthesys SA (Hexacath France)
• Original Assignee: Arthesys SA (Hexacath France)
• Inventors: Hilaire, Pierre
• Primary Examiner(s): O'Connor, Cary E.
• Application Number:
  US09/406,047
• Time in Patent Office: 1,044 Days
• Field of Search: 606/200, 606/195, 606/108
• 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 17/1214 Coils or wires
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/12081 detachable by inflation

Abstract

Apparatus and methods are described for treating cardiovascular diseases with an embolization coil placement system utilizing an embolization coil and a pusher device. The embolization coil includes a releasable attachment assembly with a deformable ring-shaped member for connecting the embolization coil to a hydraulic pressure actuated coil release assembly on the pusher device. The coil release assembly includes a coil mounting wire with a bulbous distal portion that extends distally from a proximal tubular portion of the pusher device. A small inflatable balloon is mounted on the pusher device surrounding the coil mounting wire and fluidly connected to the proximal tubular portion. The embolization coil delivery system is prepared for use by crimping the deformable ring-shaped member around the deflated balloon member and the mounting wire. The bulbous distal portion of the mounting wire retains the crimped ring-shaped member on the pusher device. A target site in the vascular system is catheterized with a microcatheter. Then, the pusher device with the embolization coil mounted on it is inserted into the microcatheter and advanced to the target site. Once the embolization coil is in position, the inflatable balloon is pressurized with a syringe or inflation device connected to a hub on the proximal tubular portion of the pusher device. As the inflatable balloon member expands, it deforms the ring-shaped member to release the embolization coil from the pusher device. The balloon member is then deflated and the pusher device is withdrawn. In this way, one or more embolization coils may be inserted to occlude the target site by creating a physical barrier to blood flow and encouraging thrombus formation.

Claims

1. Apparatus for treatment of vascular diseases, comprising:

an implantable embolization device; and

a delivery device for placement of said embolization device;

wherein said embolization device has a deformable attachment member for attaching said embolization device to said delivery device, and wherein said delivery device includes a pressure actuated release assembly comprising an inflatable balloon for deforming said attachment member, thereby releasing said embolization device from said delivery device, and a mounting wire positioned within said inflatable balloon.

2. The apparatus of claim 1, wherein said attachment member is formed of a malleable metal.

3. The apparatus of claim 1, wherein said delivery device further comprises a tubular proximal portion fluidly connected to said inflatable balloon.

4. The apparatus of claim 3, wherein said mounting wire is affixed to a distal end of said tubular proximal portion.

5. The apparatus of claim 1, wherein said mounting wire further comprises a bulbous portion for retaining said attachment member on said delivery device prior to being released.

6. The apparatus of claim 1, wherein said attachment member comprises a deformable ring-shaped member.

7. The apparatus of claim 6, wherein said deformable ring-shaped member has a convoluted configuration.

8. The apparatus of claim 6, wherein said deformable ring-shaped member has a generally tubular configuration.

9. The apparatus of claim 1, wherein said implantable embolization device comprises a helical wire coil.

10. Apparatus for treatment of vascular diseases, comprising:

an implantable embolization device; and

a delivery device for placement of said embolization device;

wherein said embolization device has a deformable attachment member for attaching said embolization device to said delivery device, and wherein said delivery device includes a pressure actuated release assembly for deforming said attachment member, thereby releasing said embolization device from said delivery device;

wherein said delivery device further comprises a tubular proximal portion and a mounting wire, having a bulbous portion, extending distally from said tubular proximal portion, and said pressure actuated release assembly comprises an inflatable balloon surrounding said mounting wire and fluidly connected to said tubular proximal portion;

and wherein said implantable embolization device comprises a helical wire coil and said attachment member comprises a deformable ring-shaped member encircling said inflatable balloon and said mounting wire prior to being released.

11. The apparatus of claim 10, wherein said deformable ring-shaped member has a convoluted configuration.

12. The apparatus of claim 10, wherein said deformable ring-shaped member has a generally tubular configuration.

13. The apparatus of claim 10, wherein said deformable ring-shaped member is an extension of said helical wire coil.

14. The apparatus of claim 10, wherein said tubular proximal portion of said delivery device comprises a metallic tube.

15. The apparatus of claim 10, wherein said delivery device further comprises a connector hub attached to a proximal end of said tubular proximal portion.

16. Apparatus for treatment of vascular diseases, comprising:

a delivery device comprising a tubular proximal portion and a mounting wire, having a bulbous portion, extending distally from said tubular proximal portion, and a pressure actuated release assembly comprising an inflatable balloon surrounding said mounting wire and fluidly connected to said tubular proximal portion; and

an implantable embolization device comprising a helical wire coil and an attachment member configured as a deformable ring-shaped member encircling said inflatable balloon and said mounting wire proximal to said bulbous portion.

17. The apparatus of claim 16, wherein said inflatable balloon is inflatable to an inflated diameter at least as large as an outer diameter of said bulbous portion, thereby deforming said attachment member and releasing said embolization device from said delivery device.

18. The apparatus of claim 16, wherein said deformable ring-shaped member has a convoluted configuration.

19. The apparatus of claim 16, wherein said deformable ring-shaped member has a generally tubular configuration.

20. The apparatus of claim 16, wherein said deformable ring-shaped member is an extension of said helical wire coil.

21. The apparatus of claim 16, wherein said tubular proximal portion of said delivery device comprises a metallic-tube.

22. The apparatus of claim 16, wherein said delivery device further comprises a connector hub attached to a proximal end of said tubular proximal portion.

23. A method of therapeutic embolization of a body passage, comprising:

inserting a delivery device, having an inflatable balloon and a mounting wire positioned within said inflatable balloon, with an implantable embolization device mounted thereon, into the body passage;

pressurizing said inflatable balloon on said delivery device to deform an attachment member on said implantable embolization device, thereby releasing said embolization device from said delivery device.

24. The method of claim 23, wherein said implantable embolization device comprises a helical wire embolization coil and wherein the method comprises releasing said embolization col into a patient'"'"'s blood vessel.

25. The method of claim 23, wherein said delivery device is inserted into a patient'"'"'s blood vessel through a catheter.

26. The method of claim 23, further comprising withdrawing said delivery device from said body passage after releasing said embolization device from said delivery device.

27. The method of claim 23, further comprising:

prior to inserting said delivery device into the body passage, mounting said implantable embolization device onto said delivery device by crimping said attachment member onto said inflatable balloon and said mounting wire.

28. A method of therapeutic embolization of a body passage, comprising:

inserting a delivery device, having an implantable embolization device mounted thereon, into the body passage;

pressurizing a pressure actuated release assembly on said delivery device to deform an attachment member on said implantable embolization device, thereby releasing said embolization device from said delivery device;

wherein said pressure actuated release assembly comprises an inflatable balloon, and wherein said inflatable balloon is pressurized with a fluid to inflate said inflatable balloon, thereby deforming said attachment member and releasing said embolization device from said delivery device; and

wherein said delivery device further comprises a tubular proximal portion fluidly connected to said inflatable balloon and a mounting wire, having a bulbous portion, extending distally from said tubular proximal portion and positioned within said inflatable balloon, said attachment member encircling said inflatable balloon and said mounting wire proximal to said bulbous portion, and wherein said inflatable balloon is inflated to an inflated diameter at least as large as an outer diameter of said bulbous portion, thereby deforming said attachment member and releasing said embolization device from said delivery device.