Total occlusion guidewire device

• US 20020128677A1
• Filed: 03/06/2001
• Published: 09/12/2002
• Est. Priority Date: 03/06/2001
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Hojeibane, Hikmat, Majercak, David C., Duerig, Thomas W.
• Granted Patent: US 6,579,302 B2
• Time in Patent Office: Days
• US Class Current: 606/198
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/0905 extendable, e.g. mechanisms for extension

Abstract

A guidewire comprising a spreader or at least one centering device which may be used to open occluded vessels or other biological passages, especially chronic total occlusions. The guidewire may be used to either open the lumen or to center a boring device within the lumen, so that the chronic total occlusion can be crossed, and an interventional procedure can then be performed.

Claims

1. A guidewire for insertion into a lumen, said guidewire comprising:

a flexible wire having an outer diameter, an inner diameter, a proximal end and a distal end;

a generally solid core wire having an outer diameter, a proximal end and a distal end, said distal end of said core wire slidably insertable into said proximal end of said flexible wire; and

a spreader attached to said distal end of said flexible wire, said spreader having a proximal end and a distal end, a smaller first diameter for insertion into said lumen, and a second larger diameter for expanding said lumen, said spreader maintaining said smaller first diameter when said core wire is slidably inserted through said flexible wire and said spreader, until said distal end of said core wire is substantially in contact with said distal end of said spreader, and said spreader having said larger second diameter when said spreader and said flexible wire are slidably advanced over said core wire until said distal end of said core wire is substantially in contact with said proximal end of said spreader.

2. The guidewire according to claim 1, wherein said flexible wire is made from super-elastic Nickel-Titanium alloy.

3. The guidewire according to claim 1, wherein said flexible wire incorporates segments made from polymeric material.

4. The guidewire according to claim 1, wherein said core wire has an outer diameter and an inner diameter.

5. The guidewire according to claim 1, wherein said spreader is made from super-elastic Nickel Titanium alloy.

6. The guidewire according to claim 1, wherein said flexible wire and said spreader are both made from super-elastic Nickel-Titanium alloy.

7. The guidewire according to claim 1, wherein said spreader comprises a proximal portion and a distal portion, and a plurality of longitudinally arranged struts extending therebetween.

8. The guidewire according to claim 1, wherein said spreader comprises a proximal portion and a distal portion, and a plurality of circumferentially arranged struts extending in a spiral pattern therebetween.

9. The guidewire according to claim 1, wherein said spreader comprises a proximal portion and a distal portion, and a plurality of hingedly connected struts extending therebetween.

10. A guidewire according to claim 1, wherein said spreader is permanently or removably attached to said distal end of said flexible wire.

11. A guidewire for insertion into a lumen, said guidewire comprising:

a flexible wire having an outer diameter, an inner diameter, a proximal end and a distal end;

a spreader attached to said distal end of said flexible wire, said spreader having a proximal end and a distal end, a plurality of struts extending therebetween, a smaller first diameter for insertion into said lumen, and a second larger diameter for expanding said lumen; and

a generally solid core wire having an outer diameter, a proximal end and a distal end, a longitudinal axis therebetween, with said distal end of said solid core wire slidably insertable into said proximal end of said flexible wire, and said distal end of said core wire permanently attached to said distal end of said spreader, wherein said spreader maintaining said smaller first diameter when said solid core wire is slidably advanced through said flexible wire and said spreader and said struts assume a position substantially parallel to said core wire, and said spreader having said larger second diameter when said flexible wire and said spreader are slidably advanced over said core until said struts assume a position substantially removed from said longitudinal axis of said core wire.

12. The guidewire according to claim 11, wherein said flexible wire is made from super-elastic Nickel-Titanium alloy.

13. The guidewire according to claim 11, wherein said flexible wire incorporates segments made from polymeric material.

14. The guidewire according to claim 11, wherein said core wire has an outer diameter and an inner diameter.

15. The guidewire according to claim 11, wherein said spreader is made from super-elastic Nickel Titanium alloy.

16. The guidewire according to claim 11, wherein said flexible wire and said spreader are both made from super-elastic Nickel-Titanium alloy.

17. The guidewire according to claim 11, wherein said spreader comprises a proximal portion and a distal portion, and a plurality of longitudinal struts extending therebetween.

18. The guidewire according to claim 11, wherein said spreader comprises a proximal portion and a distal portion, and a plurality of circumferential struts extending in a spiral pattern therebetween.

19. The guidewire according to claim 11, wherein said spreader comprises a proximal portion and a distal portion, and a plurality of hingedly connected struts extending therebetween.

20. The guidewire according to claim 11, wherein said spreader is permanently or removably attached to said distal end of said flexible wire.

21. A guidewire for insertion into a lumen, said guidewire comprising:

a flexible wire having an outer diameter, an inner diameter, a proximal end and a distal end;

a sheath, having an outer diameter and an inner diameter, a proximal end and a distal end, with said distal end of said sheath slidably insertable over said proximal end of said flexible wire;

a spreader attached to said distal end of said flexible wire, said spreader having a proximal end and a distal end, a smaller first diameter for insertion into said lumen, and a second larger diameter for expanding said lumen, said spreader having said smaller first diameter when said sheath is slidably inserted over said flexible wire and said spreader, until said distal end of said sheath is substantially in contact with said distal end of said spreader, and said spreader having said larger second diameter when said sheath is slidably retracted over said flexible wire until said distal end of said sheath is substantially in contact with said proximal end of said spreader.

22. The guidewire according to claim 21, wherein said flexible wire is made from super-elastic Nickel-Titanium alloy.

23. The guidewire according to claim 21, wherein said flexible wire incorporates segments made from a polymeric material.

24. The guidewire according to claim 21, wherein said spreader is made from super-elastic Nickel Titanium alloy.

25. The guidewire according to claim 21, wherein said flexible wire and said spreader are both made from super-elastic Nickel-Titanium alloy.

26. The guidewire according to claim 21, wherein said spreader comprises a proximal portion and a distal portion, and a plurality of longitudinal struts extending therebetween.

27. The guidewire according to claim 21, wherein said spreader comprises a proximal portion and a distal portion, and a plurality of circumferential struts extending in a spiral pattern therebetween.

28. The guidewire according to claim 21, wherein said spreader comprises a proximal portion and a distal portion, and a plurality of hingedly connected struts extending therebetween.

29. The guidewire according to claim 21, wherein said sheath is made from a polymeric material.

30. The guidewire according to claim 21, wherein said spreader is permanently or removably attached to said distal end of said flexible wire.

31. A guidewire for insertion into a lumen, said guidewire comprising:

a flexible wire having an outer diameter, an inner diameter, a proximal end and a distal end;

a generally solid, rotatable core wire having an outer diameter, a proximal end and a distal end, with said distal end of said rotatable core wire slidably inserted into said proximal end of said flexible wire;

a guide tip attached to said distal end of said rotatable core wire, wherein said guide tip comprises a boring surface;

a sheath, having an outer diameter and an inner diameter, a proximal end and a distal end, with said distal end of said sheath slidably insertable over said proximal end of said flexible wire; and

at least one centering device attached to said distal end of said flexible wire, said at least one centering device having a proximal end and a distal end, a smaller first diameter for insertion into said lumen, and a second larger diameter for centering said flexible wire in said lumen, said at least one centering device having said smaller first diameter when said sheath is slidably inserted over said flexible wire and said centering device, until said distal end of said sheath is substantially in contact with said guide tip, and said at least one centering device having said larger second diameter when said sheath is slidably retracted from said guide tip until said distal end of said sheath is no longer in contact with said at least one centering device.

32. The guidewire according to claim 31, wherein there are a plurality of centering devices.

33. The guidewire according to claim 31, wherein said plurality of centering devices each have a proximal end and a distal end, a smaller first diameter for insertion into said lumen, and a second larger diameter for centering said flexible wire in said lumen.

34. The guidewire according to claim 31, wherein said flexible wire is made from super-elastic Nickel-Titanium alloy.

35. The guidewire according to claim 31, wherein said flexible wire incorporates segments made from a polymeric material.

36. The guidewire according to claim 31, wherein said at least one centering device is made from super-elastic Nickel Titanium alloy.

37. The guidewire according to claim 31, wherein said flexible wire and said at least one centering device are both made from super-elastic Nickel-Titanium alloy.

38. The guidewire according to claim 31, wherein said at least one centering device comprises a proximal portion and a distal portion, and a plurality of longitudinal struts extending therebetween.

39. The guidewire according to claim 31, wherein said at least one centering device comprises a proximal portion and a distal portion, and a plurality of circumferential struts extending in a spiral pattern therebetween.

40. The guidewire according to claim 31, wherein said at least one centering device comprises a proximal portion and a distal portion, and a plurality of hingedly connected struts extending therebetween.

41. The guidewire according to claim 31, wherein said sheath is made from a polymeric material.

42. The guidewire according to claim 31, wherein said at least one centering device is permanently or removably attached to said distal end of said flexible wire.

43. The guidewire according to claim 31, wherein said boring guide tip is permanently or removably attached to said distal end of said flexible wire.

44. A method for crossing an intravascular occlusion in a lumen, comprising the steps of:

(a) inserting a guidewire into said lumen, said guidewire having a proximal end and a distal end;

(b) advancing said guidewire through said lumen until said intravascular occlusion is reached;

(c) placing a spreader, attached to said distal end of said guidewire, in proximity to said occlusion;

(d) slidably advancing said spreader and said guidewire over a core wire until said spreader substantially achieves a larger second diameter and opens said occlusion;

(e) slidably advancing said core wire through said guidewire and said spreader until said spreader substantially achieves a smaller first diameter; and

(f) repeating steps c through e by advancing said guidewire and said spreader over said core wire and then advancing said core wire through said guidewire and said spreader wire until said occlusion in said lumen is fully opened.

45. A method for crossing an intravascular occlusion in a lumen, comprising the steps of:

(a) inserting a guidewire into said lumen, said guidewire having a proximal end and a distal end;

(b) advancing said guidewire through said lumen until said intravascular occlusion is reached;

(c) placing a spreader, at said distal end of said guidewire, in proximity to said occlusion;

(d) slidably retracting a sheath over said spreader until said spreader substantially achieves a larger second diameter and opens said occlusion;

(e) slidably advancing said sheath over said spreader until said spreader substantially achieves a smaller first diameter; and

(f) repeating steps c through e by placing said spreader as close as possible to said occlusion, slidably retracting said sheath over said spreader and then advancing said sheath over said spreader until said occlusion in said lumen is fully opened.

46. A method for crossing an intravascular occlusion in a lumen, comprising the steps of:

(a) inserting a guidewire into said lumen, said guidewire having a proximal end and a distal end;

(b) advancing said guidewire through said lumen until said intravascular occlusion is reached;

(c) placing a guide tip of a rotatable core wire in proximity to said occlusion;

(d) slidably retracting a sheath over at least one centering device, at said distal end of said guidewire, until said at least one centering device substantially achieves a larger second diameter and centers said guidewire in said lumen;

(e) slidably advancing said rotatable core wire through said guidewire until a boring surface of said guide tip of said rotatable core wire is substantially in contact with said occlusion; and

(f) rotating and slidably advancing said rotatable core wire with said guide tip and said boring surface until said occlusion in said lumen is fully opened.