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

• US 5,895,385 A
• Filed: 11/06/1997
• Issued: 04/20/1999
• Est. Priority Date: 03/13/1990
• Status: Expired

• 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
• Application Number:
  US08/944,827
• Time in Patent Office: 530 Days
• Field of Search: 606/32, 606/41, 606/49, 606/28, 606/108, 606/191, 606/200, 600/529, 600/585, 604/104, 607/122, 623/1, 623/12
• 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 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 2017/22038 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 2025/0042 : Microcatheters, cannula or the like having outside diameters around 1 mm or less
• 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, aneurysms 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 adapted to form an occlusion within a body cavity having fluid disposed therein comprising:

a wire; and

a separable distal tip section adapted to be disposed into said body cavity to substantially space occupy said body cavity to mechanically form said occlusion within said body cavity about said separable distal tip section wherein mechanically forming an occlusion is defined as forming an occlusion so that fluid flow is substantially inhibited, said separable distal tip being adapted to be nonthermally separated from said wire to leave said separable distal tip section within said body cavity, wherein nonthermal separation is defined as a detachment without substantially increasing the temperature of said distal tip section, wherein said separable distal tip section is separated from said wire without necessarily displacing said distal tip section therefrom, wherein said separable distal tip section has no memory of its predisposed shape other than at most a relaxed simple helical shape,

whereby said body cavity is occluded by said distal tip section, and any thrombus formed by use of said distal tip section.

2. The apparatus of claim 1 wherein said separable distal tip section is mechanically detachable from said wire.

3. The apparatus of claim 1 further comprising a catheter and where said wire and distal tip section are longitudinally displaced within said catheter, said catheter having a radioopaque proximal marker, said wire and distal tip section having collectively a single radioopaque marker, said displacement of said wire and distal tip section moving said single radioopaque marker to the proximity of said proximal marker on said catheter when said distal tip section is fully deployed in said cavity.

4. The apparatus of claim 1 where said distal tip section comprises a long flexible distal tip section having a plurality of filaments extending therefrom to pack said body cavity.

5. The apparatus of claim 1 wherein said distal tip section is sufficiently long and flexible to fold upon itself a multiple number of times to occupy said body cavity to substantially impede fluid flow therein.

6. An apparatus for forming an occlusion in a body cavity comprising:

a microcatheter having a distal electrode;

a wire having a distal tip;

a distal tip electrode on said wire, said distal tip of said wire for substantially space filling said cavity to form said occlusion about said distal tip by application of a current between said distal tip electrode on said wire and said distal electrode on said microcatheter; and

a nonthermal detachment coupling between said distal tip of said wire and a remaining portion of said wire, wherein nonthermal detachment is defined as a detachment without substantially increasing the temperature of said detachment coupling,

whereby said cavity is occluded by said distal tip and a thrombus formed thereby.

7. An apparatus for use in occluding a body cavity comprising:

a wire; and

a detachable elongate distal tip coupled to said wire, said elongate distal tip being a relaxed coil capable of being multiply folded upon itself.

8. The improvement of claim 7 wherein said elongate distal tip is a long and substantially pliable segment adapted to be multiply folded upon itself to sufficiently occupy said body cavity to impede fluid flow therein.

9. The improvement of claim 7 wherein said elongate tip is a segment adapted to be disposed in said body cavity and has a plurality of filaments extending therefrom to sufficiently occupy said body cavity to impede fluid flow therein.

10. The improvement of claim 7 further comprising a catheter having a pair of radioopaque markers disposed thereon and having a distal end, said wire having a radioopaque marker disposed thereon, said marker on said wire being positioned in the proximity of one of said pair of markers on said catheter when said wire is fully deployed in said body cavity, said other marker of said pair of markers on said catheter indicating said distal end of said catheter.

11. The improvement of claim 7 where said distal tip is coupled to said wire by a polymeric bead.

12. The improvement of claim 11 where said bead is polyester.

13. The apparatus of claim 7 wherein said detachable elongate tip is a coil having a length between 1 and 50 cm.

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

a catheter having a distal end for disposition in proximity to said cavity and having an electrode disposed thereon;

a conductive wire disposed in said catheter and longitudinally displaceable therein, said wire comprising;

a core wire having a distal portion; and

an elongate tip portion extending from said core wire for a predetermined lineal extent and adapted to being packed into said cavity and coupled to said distal portion of said core wire, said occlusion being formed by means of application of a current between said elongate tip portion and said electrode on said catheter when said elongate tip portion is disposed in said cavity, said elongate tip portion being a relaxed coil having no substantial memory of its predisposed shape other than at most a relaxed simple helical shape,

whereby occlusion of said cavity is performed.

15. In an apparatus having a wire for forming an occlusion in a body cavity having a fluid flowing therein, the improvement comprising:

a deformable object temporally coupled to said wire for disposition into said cavity having no preferred geometric form when disposed into said cavity, said deformable object capable of being multiply folded upon itself, said deformable object substantially impeding movement of said fluid in said cavity to thereby form said occlusion,

whereby said cavity is occluded by said object.

16. The improvement of claim 15 where said deformable object is adapted to being packed into said body cavity to substantially obstruct said cavity.

17. The improvement of claim 16 where said object comprises a detachable, elongate, coil wire tip which is capable of being multiply folded upon itself in said body cavity.

18. The improvement of claim 16 where said deformable object has a multiplicity of flexible filaments extending therefrom.

19. The improvement of claim 15 wherein said deformable object comprises a means for slowing fluid movement in said cavity to initiate formation of said occlusion in said cavity.

20. The improvement of claim 15 further comprising a source of electrical current coupling to said deformable object and wherein said occlusion is formed by application of current to said deformable object.

21. The improvement of claim 20 further comprising a catheter and a proximal electrode on said catheter used to dispose said deformable object into said cavity, said current being applied by said means between said deformable object and said proximal electrode.

22. The improvement of claim 15 where said deformable object is adapted to mechanically form said occlusion within said cavity.

23. The improvement of claim 15 further comprising a source of electrical current coupling to said deformable object, wherein said occlusion is simultaneously formed by application of current to said deformable object and wherein said occlusion is mechanically formed by said deformable object within said cavity.

24. An apparatus adapted to form an occlusion within a body cavity used in combination with a catheter comprising:

a wire;

a detachable elongate distal tip portion coupled to and extending from said wire for a predetermined lineal extent, said detachable elongate distal tip portion being adapted to being packed into said body cavity to form said occlusion in said body cavity, said elongate distal tip portion including a first flexible, shapeless segment having substantially no memory of its predisposition shape other than at most a relaxed, simple helical shape for disposition into said cavity and a second segment for coupling said first segment to said wire, said second segment being adapted to be electrolyzed upon application of current; and

an insulating coating disposed on said first segment, said second segment being left exposed to permit selective electrolysis thereof,

whereby occlusion of said body cavity is achieved.

25. An apparatus adapted to form an occlusion within a body cavity having fluid disposed therein comprising:

a wire adapted for disposition near an opening into said body cavity;

a distal tip coupled to said wire adapted to substantially occupy said body cavity to form said occlusion within said body cavity about said distal tip, said distal tip being characterized by being adapted to carry electrical current therethrough to form an electrothrombosis in said body cavity, and being mechanically detachable from said wire to leave said distal tip within said body cavity,

whereby said body cavity is occluded by said distal tip, and any thrombus formed by use of said distal tip.

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

disposing a relaxed wire into said body cavity, said relaxed wire having no substantial memory of its predisposed shape other than at most a relaxed, simple helical shape;

disposing a separable distal tip of said relaxed wire to substantially space occupy said body cavity to mechanically form said occlusion within said body cavity about said separable distal tip; and

nonthermally detaching said separable distal tip from said wire without necessarily displacing said distal tip from said wire in order to detach said distal tip from said wire, wherein nonthermal detachment is defined as a detachment without substantially increasing the temperature of a coupling between said distal tip and wire,

whereby said body cavity is occluded by said distal tip, and a thrombus formed by use of said tip.

27. The method of claim 26 where said step of detaching a separable distal tip of said relaxed wire mechanically detaches said distal tip from said wire.

28. The method of claim 26 where said wire and tip are used with a catheter and where in said step of nonthermally detaching said distal tip from said wire, said wire and tip are longitudinally displaced within said catheter, said catheter having a radioopaque proximal marker, said wire and tip having collectively a single radioopaque marker, said displacement of said wire and tip moving said single radioopaque marker to the proximity of said proximal marker on said catheter when said tip is fully deployed in said cavity.

29. The method of claim 26 where said step of disposing said tip comprises disposing a long flexible tip having a plurality of filaments extending therefrom to pack said body cavity.

30. The method of claim 26 where said step of disposing a relaxed wire into said body cavity disposes a long and flexible coil which folds upon itself a multiple number of times to occupy said body cavity to substantially impede fluid flow therein.

31. A method for forming an occlusion in a body cavity comprising:

disposing a microcatheter having a distal electrode near an opening into said body cavity;

disposing a wire having a distal tip electrode into said body cavity to substantially fill said cavity to form said occlusion about said distal tip electrode by application of a current between said distal tip electrode on said wire and said distal electrode on said microcatheter; and

nonthermally detaching a distal tip of said wire from a remaining portion of said wire, wherein said distal tip is coupled to said remaining portion by a detachment coupling and wherein nonthermal detachment is defined as a detachment without substantially increasing the temperature of said detachment coupling,

whereby said cavity is occluded by said distal tip and a thrombus formed thereby.

32. A method of forming an occlusion within a body cavity used in combination with a wire comprising the step of:

packing at least one detachable elongate distal tip portion coupled to and extending from said wire for a predetermined lineal extent into said body cavity to form said occlusion in said body cavity, said elongate distal tip portion being a relaxed coil capable of being multiply folded upon itself; and

detaching said elongate distal tip portion from said wire,

whereby occlusion of said body cavity is achieved.

33. The wire of claim 32 where said step of packing at least one detachable elongate distal tip into said body cavity packs a long and substantially pliable segment adapted to be multiply folded upon itself to sufficiently occupy said body cavity to impede fluid flow therein.

34. The method of claim 32 wherein said step of packing said elongate tip portion packs a segment in said body cavity having a plurality of filaments extending therefrom to sufficiently occupy said body cavity to impede fluid flow therein.

35. The method of claim 32 further comprising the step of disposing said wire into a catheter having a pair of radioopaque markers disposed thereon and having a distal end, said wire having a radioopaque marker disposed thereon, said marker on said wire being positioned in the proximity of one of said pair of markers on said catheter when said wire is fully deployed in said body cavity and said other marker of said pair of markers on said catheter indicating said distal end of said catheter during said step of packing.

36. The wire of claim 32 where in said step of packing said distal tip portion is coupled to said wire by a polyester bead.

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

disposing a catheter having an electrode disposed thereon and having a distal end in proximity to said cavity;

disposing a conductive wire in said catheter and longitudinally displaceable therein, said wire comprising a core wire having a distal portion;

and an elongate tip portion extending from said core wire for a predetermined lineal extent and coupled to said distal portion of said core wire;

packing said elongate tip portion into said cavity;

forming said occlusion by means of application of a current between said elongate tip portion and said electrode on said catheter when said elongate tip portion is disposed in said cavity, said elongate tip portion being a relaxed coil having no substantial memory of its predisposed shape other than at most a relaxed simple helical shape,

whereby occlusion of said cavity is performed.

38. In a method for forming an occlusion in a body cavity having a fluid flowing therein by disposing a wire at least adjacent to said body cavity, the improvement comprising:

disposing a deformable object into said cavity having no preferred geometric form when disposed into said cavity, said deformable object capable of being multiply folded upon itself, said deformable object substantially impeding movement of said fluid in said cavity to thereby form said occlusion, whereby said cavity is occluded by said object.

39. The improvement of claim 38 where said step of disposing said deformable object packs said deformable object into said body cavity to substantially obstruct said cavity.

40. The improvement of claim 39 where said step of disposing said deformable object packs said object into said cavity by disposition of a detachable, elongate, coil wire tip which is multiply folded upon itself in said body cavity.

41. The improvement of claim 39 where said step of disposing said deformable object packs said deformable object having a multiplicity of flexible filaments extending therefrom into said cavity.

42. The improvement of claim 38 where said step of disposing said deformable object comprises the step of slowing fluid movement in said cavity to initiate formation of said occlusion in said cavity.

43. The improvement of claim 38 in combination with a catheter having a proximal electrode and used to dispose said deformable object into said cavity, and further comprising the step of applying electrical current to said deformable object and wherein said occlusion is formed by application of current between said deformable object and said proximal electrode.

44. The improvement of claim 38 where disposing a deformable object into said cavity mechanically forms said occlusion within said cavity.

45. The improvement of claim 38 further comprising a source of electrical current coupling to said deformable object, where disposing a deformable object into said cavity mechanically forms said occlusion within said cavity and where said occlusion is simultaneously formed by application of current to said deformable object from said electrical source.

46. A method for forming an occlusion within a body cavity in combination with a catheter comprising:

packing a detachable elongate distal tip portion coupled to and extending from a wire into said body cavity to form said occlusion in said body cavity, said elongate distal tip portion including a first flexible, shapeless segment having substantially no memory of its predisposition shape other than at most a relaxed, simple helical shape for disposition into said cavity and a second segment for coupling said first segment to said wire; and

electrolytically disconnecting said second segment from said wire upon application of current to said second segment, an insulating coating disposed on said first segment, said second segment being left exposed to permit selective electrolysis thereof,

whereby occlusion of said body cavity is achieved.

47. A method for forming an occlusion within a body cavity having fluid disposed therein comprising:

disposing a wire near an opening into said body cavity;

disposing a distal tip coupled to said wire into said body cavity to substantially occupy said body cavity to form said occlusion within said body cavity about said distal tip;

forming an electrothrombosis in said body cavity about said distal tip being by applying electrical current said distal tip; and

mechanically detaching said distal tip from said wire to leave said distal tip within said body cavity,

whereby said body cavity is occluded by said distal tip, and any thrombus formed by use of said distal tip.