GUIDEWIRE FOR CROSSING OCCLUSIONS OR STENOSES HAVING A SHAPEABLE DISTAL END

• US 20080221601A1
• Filed: 08/31/2007
• Published: 09/11/2008
• Est. Priority Date: 02/25/1998
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Revascular Therapeutics Inc. (Boston Scientific Corporation)
• Inventors: Aganon, Nestor, Sudaria, Rudolfo, Huynh, Christopher, Carley, Michael, Chechelski, Victor
• Granted Patent: US 9,254,143 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 2017/003 Steerable
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member

Abstract

A hollow guidewire with a shapeable distal end, for removing tissue from a body lumen, such as a coronary artery. The hollow guidewire comprises an elongate, tubular guidewire body that has an axial lumen. A tissue removal assembly, such as a rotating drive shaft, is positioned at or near a distal end of the tubular guidewire body and extends through the axial lumen. Actuation of the tissue removal assembly removes occlusive material in the body lumen.

Claims

1. A shapeable guidewire for crossing an occlusion or stenosis within a body lumen, said guidewire comprising:

a guidewire body having a proximal end, a distal end, and a central passage therethrough, wherein a distal region of the body is malleable so that it may be manually configured to a desired shape; and

a mechanically driven core element disposed in the central passage and passing out through the distal end of the guidewire body, wherein the core element may be rotated, oscillated, and/or translated within the central passage while the distal region of the body retains its desired shape.

2. A guidewire as in claim 1, wherein the malleable distal region comprises a tube formed from a malleable metal.

3. A guidewire as in claim 2, wherein the tube is slotted at least along a portion of its length.

4. A guidewire as in claim 3, wherein one or more slots are formed along a helical spine.

5. A guidewire as in claim 4, wherein the slots along the helical spine have interruptions.

6. A guidewire as in claim 3, wherein the slots are formed along an axial spine.

7. A guidewire as in claim 3, wherein the tube is cut into a helical ribbon along at least a portion of its length.

8. A guidewire as in claim 1, further comprising a spring element disposed along at least a portion of the malleable distal region, wherein the spring element is aligned to help hold a desired shape.

9. A guidewire as in claim 8, wherein, the spring comprises a linear spring axially aligned along one side of at least a portion of the malleable distal region, wherein the spring has an arcuate memory and helps hold an arc manually formed in the malleable region.

10. A guidewire a in claim 8, wherein the spring element is formed from a shape memory material

11. A guidewire as in claim 8, wherein the malleable distal region and the core element are at least partially separated by a liner.

12. A guidewire as in claim 11, wherein the liner is at least in part a coil.

13. A guidewire according to claim 1, wherein the malleable distal region comprises a heat-sensitive component that can be softened by heating.

14. A guidewire as in claim 13, wherein the heat-sensitive component comprises a polymer jacket disposed along at least a portion of the malleable distal region.

15. A guidewire according to claim 1, wherein the guidewire body is formed from either or both a first and a second solid walled tube.

16. A guidewire according to claim 15, wherein the first solid walled tube extends proximally from at least a longitudinal portion of the malleable region to the proximal end of the guidewire.

17. A guidewire according to claim 15, wherein the first solid walled tube extends proximally from at least a longitudinal portion of the malleable region, and a distal end of the second solid walled tube which extends to the proximal end of the guidewire.

18. A guidewire according to claim 15, wherein the first solid walled tube and the second solid walled tubes are formed, respectively, from nickel titanium and stainless steel.

19. A guidewire according to claim 1, wherein a housing is disposed at the proximal end of the guidewire and contains a motor for moving the core element.

20. A guidewire as in claim 1, wherein the core element comprises a drive shaft formed from nickel titanium, and a distal tip.

21. A guidewire according to claim 19, wherein the motor is attached to a controller system.

22. A guidewire as in claim 21, wherein the controller causes the motor to rotationally oscillate the core element.

23. A guidewire according to claim 22, wherein the controller oscillates the core element at a preset rotational speed and changes rotational direction at a preset period.

24. A guidewire according to claim 1, wherein the proximal end of the guidewire body is configured for attachment to a distal end of an extension body.

25. A guidewire according to claim 1, wherein the distal-most 10 mm of the guidewire body has a column strength in the range from 3 g to 50 g.

26. A guidewire according to claim 25, wherein the column strength is in the range from 6 g to 35 g.

27. A method for crossing a luminal occlusion, said method comprising:

providing a shapeable guidewire;

manually shaping a distal end of the guidewire;

advancing the guidewire through an occlusion while a core carried by the guidewire is mechanically driven to engage and penetrate the occlusion while the core holds the shape defined by the manually shaped distal end of the guidewire.

28. A method as in claim 27, wherein the core is rotated, oscillated, translated, or a combination thereof as the guidewire is advanced.

29. A method as in claim 27, wherein manually shaping comprises shaping a spring element at the distal end of the guidewire, wherein the spring element helps to hold the shape of the guidewire as the core is driven.

30. A method as in claim 29, wherein the distal end of the guidewire comprises a slotted tube.

31. A method as in claim 27, wherein the distal end has a column strength in the range from 3 g to 50 g.

32. A method as in claim 31, wherein the column strength is in the range from 6 g to 35 g.

33. A method as in claim 27, further comprising advancing the guidewire while the core is not being driven.