Endovascular electrolytically detachable wire and tip for the formation of thrombus in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas

• US 5,855,578 A
• Filed: 02/14/1997
• Issued: 01/05/1999
• Est. Priority Date: 03/13/1990
• Status: Expired due to Term

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: Regents of the University of California (University of California)
• Inventors: Sepetka, Ivan, Guglielmi, Guido
• Primary Examiner(s): COHEN, LEE S
• Application Number:
  US08/801,795
• Time in Patent Office: 690 Days
• Field of Search: 606/32, 606/41, 606/49, 606/28, 606/585, 606/108, 606/191, 606/200, 600/585, 623/1, 623/12, 604/104, 607/122
• US Class Current: 606/32
• 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 17/12145 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 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/00886 Duration
• CPC Class Codes: A61B 2018/1226 powered by a battery
• CPC Class Codes: A61B 2018/1253 monopolar
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1266 with DC current output
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1495 : Electrodes being detachable from a support structure
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/09175 : having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/09 : Guide wires

Abstract

An artery, vein, aneurysm, vascular malformation or arterial fistula is occluded through endovascular occlusion by the endovascular insertion of a platinum wire and/or tip into the vascular cavity. The vascular cavity is packed with the tip to obstruct blood flow or access of blood in the cavity such that the blood clots in the cavity and an occlusion if formed. The tip may be elongate and flexible so that it packs the cavity by being folded upon itself a multiple number of times, or may pack the cavity by virtue of a filamentary or fuzzy structure of the tip. The tip is then separated from the wire mechanically or by electrolytic separation of the tip from the wire. The wire and the microcatheter are thereafter removed leaving the tip embedded in the thrombus formed within the vascular cavity. Movement of wire in the microcatheter is more easily tracked by providing a radioopaque proximal marker on the microcatheter and a corresponding indicator marker on the wire. Electrothrombosis is facilitate by placing the ground electrode on the distal end of the microcatheter and flowing current between the microcatheter electrode and the tip.

Claims

1. An apparatus for forming an occlusion within a body cavity having an ionic fluid therein comprising:

a wire adapted to be disposed near an opening into said body cavity;

a separable distal tip of said wire adapted for disposition into said body cavity to form said occlusion within said body cavity about said distal tip; and

an electrolytically detachable connecting segment coupling said distal tip and said wire.

2. The apparatus of claim 1 where said distal tip has a length and flexibility to allow said distal tip sufficiently to impede flow of said fluid in said body cavity when said distal tip is disposed in said body cavity.

3. The apparatus of claim 2 where said distal tip is comprised of a radio-opaque material and has a long and pliable length sufficient to cause said cavity to appear substantially opaque as determined by fluoroscopic examination.

4. The apparatus of claim 2 where said distal tip is comprised of a plurality of segments which collectively cause said cavity to appear substantially opaque as determined by fluoroscopic examination.

5. The apparatus of claim 1 where said connecting segment electrolytically detaches said distal tip from said wire by electrolytically disintegrating at least one portion of said connecting segment extending between said wire and said distal tip.

6. The apparatus of claim 4 where said connecting segment is a coil segment which is electrolytically disintegrated to effect detachment.

7. The apparatus of claim 1 further comprising a catheter into which said wire, distal tip and connecting segment are disposed, and where said connecting segment is retained with said catheter and not at first exposed to said fluid to allow formation of said occlusion about said distal tip, and is then subsequently extended out of said catheter and exposed to said fluid to separate said distal tip from said wire.

8. An apparatus for use in formation of an occlusion used in combination with a catheter comprising:

an electrolyzable core wire having a distal portion; and

a separable elongate tip portion extending said core wire and coupled to said distal portion of said core wire, said separable elongate tip portion for insertion within a body cavity, said separable elongate tip portion not resistant to electrolytic disintegration in fluid as compared to said electrolyzable core wire, and said separable elongate tip portion being detachable from said core wire by electrolysis,

wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not as susceptible to electrolytic disintegration within fluid as said core wire, and

wherein said long and flexible segment is prebiased to form a helix when extended from said catheter.

9. The apparatus of claim 8 wherein said helix has a conical envelope.

10. The apparatus of claim 8 wherein said helix has a cylindrical envelope.

11. A method for forming an occlusion within a body cavity having an ionic fluid therein comprising the steps of:

disposing a separable distal tip of a wire into said body cavity to form said occlusion within said body cavity about said distal tip; and

electrolytically detaching said distal tip from said wire to leave said distal tip within said body cavity with said occlusion being formed within said body cavity.

12. The method of claim 11 where said step of disposing said distal tip of said wire disposes said distal tip into said body cavity to occupy said cavity to a degree sufficient to impede flow of a fluid in said body cavity.

13. The method of claim 12 where said step of disposing said distal tip of said wire disposes a distal tip having a long and pliable length.

14. The method of claim 11 where said step of electrolytically detaching said distal tip of said wire electrolytically disintegrates a connecting coupling between said wire and said distal tip to effect separation.

15. The method of claim 14 further comprising the step of shielding said coupling between said wire and distal tip from said fluid by disposing said coupling in a catheter to allow formation of said occlusion about said distal tip, and then exposing said coupling to said fluid to electrolytically separate said distal tip from said wire.

16. The method of claim 11 further comprising the step of repeating said steps of disposing a separable distal tip of a wire, and electrolytically detaching said distal tip, wherein a plurality of said distal tips are separated and disposed in said body cavity to collectively form an occlusion in said body cavity.

17. A method of using a catheter to form an occlusion comprising:

disposing an electrolyzable core wire near the situs of said occlusion;

disposing a separable elongate tip portion extending from said catheter and coupled to said core wire at said situs of said occlusion, said separable elongate tip portion being more resistant to electrolytic disintegration in fluid than said electrolyzable core wire, and being a long and substantially flexible segment prebiased to form a helix when extended from said catheter; and

detaching said separable elongate tip portion from said core wire by electrolysis.

18. The method of claim 17 where said step of disposing said separable elongate tip portion disposes said helix with a cylindrical envelope.

19. The method of claim 17 where said step of disposing said separable elongate tip portion disposes said helix with a conical envelope.

20. An apparatus for use in formation of an occlusion within a body cavity comprising:

a core wire having at least a electrolyzable distal portion; and

a separable elongate tip portion of said core wire coupled to and extending from said core wire, said separable elongate tip portion adapted to form said occlusion in said body cavity and being adapted for insertion within said body cavity, said separable elongate tip portion being resistant to electrolysis compared to said distal portion of said core wire, said separable elongate tip portion being coupled to said core wire by said electrolyzable distal portion.

21. The apparatus of claim 20 further comprising a stainless steel segment, said stainless steel segment comprising a coil having a proximate and distal end and connected at its proximate end to said core wire and connected at its distal end to said elongate tip portion of said apparatus.

22. The apparatus of claim 21 wherein said coil defines an interior space, said interior space being free and unreinforced.

23. The apparatus of claim 20 wherein said separable elongate tip portion is a long and substantially flexible segment and is comprised of a metal not as susceptible to electrolytic disintegration as said core wire.

24. The apparatus of claim 23 wherein said long and flexible segment of said elongate tip portion has a length such that when disposed in said body cavity it assumes a form which substantially impedes flow of fluid in said body cavity.