Guidewire apparatus for temporary distal embolic protection

• US 20020169472A1
• Filed: 03/15/2002
• Published: 11/14/2002
• Est. Priority Date: 04/03/2001
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Douk, Nareak, Rafiee, Nasser, Strickler, Peter G., Poole, Matt S., Jennings, Ellen M.
• Granted Patent: US 6,911,036 B2
• Time in Patent Office: Days
• 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 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22045 fixed to the catheter; guiding tip
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2002/015 Stop means therefor
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/09025 with sliding mandrils

Abstract

A guidewire apparatus for use during percutaneous catheter interventions, such as angioplasty or stent deployment. A protection element comprising a filter or an occluder is mounted near the distal end of a steerable guidewire, which guides a therapeutic catheter. The guidewire apparatus comprises a hollow shaft movably disposed about a core wire and, optionally, a slippery liner interfitted there between. The shaft and core wire control relative displacement of the ends of the protection element, causing transformation of the protection element between a deployed configuration and a collapsed configuration.

Claims

1. A guidewire apparatus comprising:

an elongate hollow shaft having an inner wall and proximal and distal ends;

a core wire movably disposed within the shaft and having a distal end extending there from;

a generally tubular protection element having a distal end fixed adjacent the core wire distal end and a proximal end fixed adjacent the shaft distal end, wherein relative longitudinal movement between the distal and proximal ends of the protection element accompanies a transformation of the protection element between a collapsed configuration and an expanded configuration; and

a liner interfitted between the core wire and the shaft inner wall, the liner having an inner surface and an outer surface, wherein at least one of the surfaces has a low coefficient of friction.

2. The guidewire apparatus of claim 1, wherein the liner inner surface has a low coefficient of friction and is sized to provide a radial clearance with the core wire.

3. The guidewire apparatus of claim 1, wherein the liner outer surface has a low coefficient of friction and is sized to provide a radial clearance with the shaft inner wall.

4. The guidewire apparatus of claim 1, wherein the liner inner and outer surfaces both have low coefficient s of friction and the liner is sized such that radial clearance s exist between the liner inner surface and the core wire, and between the liner outer surface and the shaft inner wall.

5. The guidewire apparatus of claim 1 further comprising a flexible tip member fixed about the core wire distal end.

6. The guidewire apparatus of claim 1, wherein a core wire proximal end extends from the shaft proximal end.

7. The guidewire apparatus of claim 6, wherein one or more bends are formed in a portion of the core wire within the shaft proximal end, the one or more bends providing frictional engagement with the shaft inner wall and being capable of stopping proximal slippage of the liner along the core wire.

8. The guidewire apparatus of claim 6, wherein a portion of the core wire proximal end extending from the hollow shaft is enlarged in diameter.

9. The guidewire apparatus of claim 8, wherein a reinforcement coil surrounds a segment of the core wire between the enlarged portion and the shaft proximal end.

10. The guidewire apparatus of claim 6, wherein the shaft proximal end is fixedly attached to the core wire and a portion of the hollow shaft adjacent the shaft proximal end is spirally cut to form a variable-length reinforcement coil surrounding a segment of the core wire.

11. The guidewire apparatus of claim 1, wherein the protection element is a filter.

12. The guidewire apparatus of claim 1, wherein the protection element is an occluder.

13. The guidewire apparatus of claim 5 further comprising a torque-transmitting element capable of transmitting rotation forces from the hollow shaft to the core wire.

14. The guidewire apparatus of claim 13, wherein the torque-transmitting element is a filamentous tube having proximal and distal ends and a variable length to permit longitudinal displacement between the shaft and the core wire, the tube disposed about the core wire distal end at a location extending from the shaft distal end towards the tip member, the tube proximal end being fixed to the shaft distal end and the tube distal end fixedly connected to a proximal end of the tip member.

15. The guidewire apparatus of claim 13, wherein the torque-transmitting element is a filamentous tube having proximal and distal ends and a variable length to permit longitudinal displacement between the shaft and the core wire, the tube disposed about the core wire distal end at a location extending from the shaft distal end towards the tip member, the tube proximal end being fixed to the shaft distal end and the tube distal end fixedly connected to the core wire adjacent to a proximal end of the tip member.

16. The guidewire apparatus of claim 13, wherein the torque-transmitting element comprises a flat formed on the core wire and a corresponding dimple formed in the hollow shaft, the dimple being engaged with the flat to permit longitudinal displacement between the shaft and the core wire, while transmitting rotation forces from the hollow shaft to the core wire.

18. The guidewire apparatus of claim 17, wherein the transition sleeve distal end is fixed about the tip member proximal portion.

19. The guidewire apparatus of claim 17, wherein the transition sleeve distal end is slidably disposed about the tip member proximal portion, and a pair of stop elements prevents the transition sleeve distal end from sliding proximally off of the tip member.

20. The guidewire apparatus of claim 17, wherein the protection element is self-expandable to the expanded configuration.

21. The guidewire apparatus of claim 17, wherein the hollow shaft comprises metal tubing.

22. The guidewire apparatus of claim 21, wherein the metal tubing comprises nitinol.

23. The guidewire apparatus of claim 17, wherein the liner comprises polymeric tubing.

24. The guidewire apparatus of claim 23, wherein the polymeric tubing comprises polyimide.

25. The guidewire apparatus of claim 24, wherein the at least one low-friction surface comprises a layer of polyimide having a fluoropolymer filler.

26. The guidewire apparatus of claim 23, wherein the at least one low-friction surface comprises plasma-aided surface modification.

27. The guidewire apparatus of claim 26, wherein the polymeric tubing comprises polyethylene block amide copolymer.

28. The guidewire apparatus of claim 17, wherein the liner comprises a coiled filament.

29. The guidewire apparatus of claim 17 wherein a slippery coating is disposed on the core wire.

30. The guidewire apparatus of claim 17, wherein the protection element is a filter.

31. The guidewire apparatus of claim 17, wherein the protection element is an occluder.

17. A guidewire apparatus comprising:

an elongate hollow shaft having an inner wall and a distal portion having a distal end;

a core wire movably disposed within the shaft and having a distal end extending there from and a flexible tip member fixed about the core wire distal end;

a transition sleeve having a distal end and being slidably disposed about the shaft distal portion and extending distally there from to surround a proximal portion of the tip member;

a generally tubular protection element having a distal end fixed about the transition sleeve and a proximal end fixed to the shaft proximally of the shaft distal portion, wherein relative longitudinal movement between the distal and proximal ends of the protection element accompanies a transformation of the protection element between a collapsed configuration and an expanded configuration; and

a liner interfitted between the core wire and the hollow shaft, the liner having inner and outer surfaces, wherein at least one of the surfaces has a low coefficient of friction.

32. A guidewire apparatus comprising:

an elongate hollow shaft having a length, an inner wall and a distal portion;

a liner disposed within substantially the length of the hollow shaft and having inner and outer surfaces, wherein at least one of the surfaces has a low coefficient of friction;

a core wire having separate distal and proximal sections slidably disposed within the liner, the core wire proximal section being adapted to abut and push the core wire distal section distally within the liner, the distal core wire section having a distal end extending from the shaft distal portion and having a flexible tip member fixed there about;

a transition sleeve being slidably disposed about and extending from the shaft distal portion, the sleeve having a distal end coupled about the tip member; and

a generally tubular, self-expanding protection element having a distal end coupled about the transition sleeve and a proximal end coupled to the shaft proximally of the shaft distal portion, wherein relative longitudinal movement between the distal and proximal ends of the protection element accompanies a transformation of the protection element between a collapsed configuration and an expanded configuration.

33. The guidewire apparatus of claim 32 wherein the sleeve distal end is fixedly coupled about the tip member.

34. The guidewire apparatus of claim 32 wherein the sleeve distal end is slidingly coupled about the tip member and restrained by stop members from sliding proximally off of the tip member.

35. The guidewire apparatus of claim 32 wherein the hollow shaft has an outer diameter of about 0.36 mm (0.014 inch).

36. The guidewire apparatus of claim 32 wherein the hollow shaft has an inner diameter of about 0.23 mm (0.009 inch).

37. The guidewire apparatus of claim 32 wherein the core wire distal and proximal sections have a diameter of about 0.15 mm (0.006 inch).

38. The guidewire apparatus of claim 32 wherein the liner has an outer diameter of about 0.22 mm (0.0088 inch).

39. The guidewire apparatus of claim 38 wherein the liner has an inner diameter of about 0.18 mm (0.0069 inch).

40. The guidewire apparatus of claim 32, wherein the protection element is a filter.

41. The guidewire apparatus of claim 32, wherein the protection element is an occluder.

42. A guidewire apparatus comprising:

an elongate hollow shaft having an inner wall and proximal and distal ends;

a core wire having a portion movably disposed within the hollow shaft and having a distal end extending there from, the portion of the core wire within the hollow shaft having a distal segment and a first proximal segment, the diameter of the first proximal segment being larger than the diameter of the core wire distal segment; and

a generally tubular protection element having a distal end fixed adjacent the core wire distal end and a proximal end fixed adjacent the shaft distal end, wherein relative longitudinal movement between the distal and proximal ends of the protection element accompanies a transformation of the protection element between a collapsed configuration and an expanded configuration.

43. The guidewire apparatus of claim 42 further comprising a liner interfitted between the core wire distal segment and the shaft inner wall, the liner having inner and outer surfaces, wherein at least one of the surfaces has a low coefficient of friction.

44. The guidewire apparatus of claim 43, wherein a step in diameter between the core wire distal segment and the core wire first proximal segment is capable of stopping proximal slippage of the liner along the core wire.

45. The guidewire apparatus of claim 42, wherein core wire distal segment has a length that is substantially shorter than the length of the core wire first proximal segment.

46. The guidewire apparatus of claim 42, wherein core wire first proximal segment has a length that is substantially shorter than the length of the core wire distal segment.