Apparatus and method for vascular embolization

• US 6,015,424 A
• Filed: 04/28/1998
• Issued: 01/18/2000
• Est. Priority Date: 04/28/1998
• Status: Expired due to Term

• Current Assignee: Microvention Incorporated (Terumo Corporation)
• Original Assignee: Microvention Incorporated (Terumo Corporation)
• Inventors: Rosenbluth, Robert F., Cox, Brian J., Greene, George R. Jr.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US09/069,008
• Time in Patent Office: 630 Days
• Field of Search: 606/108, 606/200, 606/191, 606/194, 623/1
• 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 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/12195 comprising a curable material
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12063 electrolytically detachable

Abstract

Apparatus for vascular embolization, deployable through a microcatheter, includes a flexible, elongate deployment tube dimensioned for insertion through the microcatheter, and a filamentous embolic device releasably attached to the distal end of the tube. The embolic device is controllably transformable from a soft, compliant state to a rigid or semi-rigid state. The embolic device may include a polymeric material that is transformable by contact with vascular blood or with a liquid that is cooler than vascular blood, or it may include a metallic material that is transformable by electrolytic corrosion. The embolic device may be a continuous filamentous polymeric extrusion; an elongate microcoil filled with polymeric material; an elongate, multi-segmented chain including polymeric interconnecting portions; or an elongate chain of metal segments that are fused together by electrolytic corrosion. An aneurysm is embolized with this apparatus by deploying a microcatheter so that its distal end is adjacent the aneurysm; deploying the embolic device through the microcatheter and into the aneurysm so that the embolic device forms a web-like mass in the aneurysm; and transforming the embolic device from its soft, compliant state to its rigid or semi-rigid state. The embolic device is advantageously deployed by releasably attaching it to a flexible, elongate deployment tube that is passed through the microcatheter, and then detaching the embolic device from the tube when the embolic device is suitably situated.

Claims

1. Apparatus for vascular embolization that is deployable through a microcatheter having an axial lumen, comprising:

a flexible, elongate, hollow deployment tube dimensioned for insertion through the lumen of the microcatheter, the deployment tube having a proximal end and a distal end; and

a filamentous embolic device having a proximal end releasably attached to the distal end of the deployment tube, the embolic device being controllably transformable from a soft, compliant state to a rigid or semi-rigid state.

2. The apparatus of claim 1, wherein the embolic device includes a polymeric material that is controllably transformable from a soft, compliant state to a rigid or semi-rigid state.

3. The apparatus of claim 2, wherein the polymeric material is transformable by contact with vascular blood.

4. The apparatus of claim 2, wherein the polymeric material is controllably transformable by contact with a biocompatible liquid that is cooler than vascular blood.

5. The apparatus of claim 3, wherein the polymeric material is mixed with a biocompatible plasticizer that is soluble in vascular blood.

6. The apparatus of claim 3, wherein the polymeric material includes a microcrystalline wax composition.

7. The apparatus of claim 5, wherein the polymeric material is selected from the group consisting of cellulose acetate polymers and polyurethane-based copolymers.

8. The apparatus of claim 7, wherein the plasticizer is selected from a group consisting of dimethylsulfoxide, ethyl lactate, and ethanol.

9. The apparatus of any of claims 2 through 8, wherein the embolic device comprises a continuous extrusion of the polymeric material.

10. The apparatus of claim 3, wherein the embolic device comprises an elongate, flexible microcoil having a hollow interior containing the polymeric material.

11. The apparatus of any of claims 2 through 8, wherein the embolic device comprises an elongate, flexible chain of multiple interlinked segments, at least some of which include an interlinking portion made of the polymeric material.

12. The apparatus of claim 1, wherein the embolic device comprises an elongate, flexible chain of multiple interlinked metal segments, wherein the chain is transformable by electrolytic corrosion.

13. The apparatus of any of claim 3, wherein the embolic device comprises an elongate, flexible chain of multiple interlinked hollow segments filled with the polymeric material.

14. The apparatus of claims 10 or 13, wherein the polymeric material is cyanoacrylate.

15. A vascular embolization device, comprising:

an elongate filamentous element that is controllably transformable from a soft, compliant state to a rigid or semi-rigid state.

16. The device of claim 15, wherein the device includes a portion formed of a polymeric material that is controllably transformable from a soft, compliant state to a rigid or semi-rigid state.

17. The device of claim 16, wherein the polymeric material is transformable by contact with vascular blood.

18. The device of claim 16, wherein the polymeric material is controllably transformable by contact with a biocompatible liquid that is cooler than vascular blood.

19. The device of claim 17, wherein the polymeric material is mixed with a biocompatible plasticizer that is soluble in vascular blood.

20. The device of claim 17, wherein the polymeric material includes a microcrystalline wax composition.

21. The device of claim 19, wherein the polymeric material is selected from the group consisting of cellulose acetate polymers and polyurethane-based copolymers.

22. The device of claim 21, wherein the plasticizer is selected from a group consisting of dimethylsulfoxide, ethyl lactate, and ethanol.

23. The device of any of claims 16 through 22, wherein the filamentous element comprises a continuous extrusion of the polymeric material.

24. The device of claim 17, wherein the filamentous element comprises an elongate, flexible microcoil having a hollow interior containing the polymeric material.

25. The device of any of claims 16 through 22, wherein the filamentous element comprises an elongate, flexible chain of multiple interlinked segments, at least some of which include an interlinking portion made of the polymeric material.

26. The device of claim 15, wherein the filamentous element comprises an elongate, flexible chain of multiple interlinked metal segments, wherein the chain is transformable by electrolytic corrosion.

27. The device claim 17, wherein the filamentous element comprises an elongate, flexible chain of multiple interlinked hollow segments filled with the polymeric material.

28. The apparatus of claims 24 or 27, wherein the polymeric material is cyanoacrylate.

29. A method of embolizing a vascular site, comprising the steps of:

(a) deploying a catheter so that its distal end is adjacent the vascular site;

(b) providing an elongate, filamentous embolic device that is controllably transformable from a soft, compliant state to a rigid or semi-rigid state;

(c) deploying the embolic device through the catheter and into the vascular site so that the embolic device forms a web-like mass in the vascular site; and

(d) transforming the embolic device from its soft, compliant state to its rigid or semi-rigid state.

30. The method of claim 29, wherein the embolic device has a proximal end and a distal end, and wherein the step of deploying comprises the steps of:

(c)(1) providing an elongate, flexible deployment tube having a distal end;

(c)(2) attaching the proximal end of the embolic device to the distal end of the deployment tube;

(c)(3) inserting the distal end of the deployment tube into the catheter; and

(c)(4) pushing the deployment tube though the catheter with the assistance of a fluid flowing through the catheter so as to carry the deployment tube and the embolic device through the catheter until the embolic device is deployed in the vascular site; and

(c)(5) detaching the embolic device from the deployment tube.

31. The method of claims 29 or 30, wherein the embolic device includes a portion made of a polymeric material that is transformable from the soft compliant state to the rigid or semi-rigid state, and wherein the step of transforming is performed by contacting the polymeric portion of the embolic device with vascular blood.

32. The method of claims 29 or 30, wherein the embolic device includes a portion made of a polymeric material that is transformable from the soft, compliant state to the rigid or semi-rigid state, and wherein the step of transforming is performed by contacting the polymeric portion of the embolic device with a biocompatible liquid that is cooler than vascular blood.

33. The method of claims 29 or 30, wherein the embolic device comprises an elongate, flexible chain of multiple interlinked metal segments, and wherein the step of transforming is performed by electrolytic corrosion of the segments.

34. The method of claims 29 or 30, wherein the embolic device has a hollow interior, and wherein the step of transforming includes the steps of:

(d)(1) injecting a transition material into the interior of the embolic device, the transition material being transformable from a flowable state to a rigid or semi-rigid state by contact with vascular blood; and

(d)(2) transforming the transition material from the flowable state to the rigid or semi-rigid state through contact with vascular blood.