High torque, low profile intravascular guidewire system

• US 20030139689A1
• Filed: 12/23/2002
• Published: 07/24/2003
• Est. Priority Date: 11/19/2001
• Status: Abandoned Application

• Current Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Shturman Cardiology Systems, Inc.
• Inventors: Filippov, Aleksi Filippovich, Shturman, Leonid, Prudnikov, Dmitrii Urjevich
• Application Number:
  US10/223,527
• Publication Number:
  US 20030139689A1
• Time in Patent Office: Days
• US Class Current: 600/585
• 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 2017/320766 eccentric
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09091 where a sheath surrounds the coil at the distal part
• CPC Class Codes: A61M 2025/09108 Methods for making a guide wire
• CPC Class Codes: A61M 2025/09133 having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
• CPC Class Codes: A61M 2025/09141 made of shape memory alloys which take a particular shape at a certain temperature
• CPC Class Codes: A61M 2025/0915 having features for changing the stiffness
• CPC Class Codes: A61M 2025/09166 having radio-opaque features
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/09025 with sliding mandrils

Abstract

A guidewire system is disclosed for performing a rotational atherectomy procedure, wherein the system includes a core wire having an elongated wire body defining a flexible distal portion and a more rigid medial portion, and a torquing sheath for positioning the core wire, the torquing sheath having a normally curved, relatively flexible distal portion and an interior lumen dimensioned and configured to accommodate the core wire, wherein the medial portion of the core wire is sufficiently rigid to straighten the normally curved distal portion of the torquing sheath when it is extended therethrough.

Claims

1. An intravascular guidewire system comprising:

a) a core wire having an elongated wire body defining a relatively flexible distal portion and a relatively rigid medial portion; and

b) a torquing sheath for positioning the core wire, the torquing sheath having a normally curved, relatively flexible distal portion and an interior lumen dimensioned and configured to accommodate the core wire, wherein the medial portion of the core wire is sufficiently rigid to straighten the normally curved, relatively flexible distal portion of the torquing sheath when the medial portion of the core wire is extending therethrough.

2. An intravascular guidewire system as recited in claim 1, wherein the wire body is formed from a monofilament structure.

3. An intravascular guidewire system as recited in claim 1, wherein the wire body is formed from a metal alloy having shape memory characteristics.

4. An intravascular guidewire system as recited in claim 3, wherein the distal portion of the wire body is heat-treated in such a manner so as to relieve the shape memory characteristics associated therewith.

5. An intravascular guidewire system as recited in claim 1, wherein the distal portion of the wire body is conically tapered.

6. An intravascular guidewire system as recited in claim 5, wherein the distal portion of the wire body is conically tapered in a center-less grinding process.

7. An intravascular guidewire system as recited in claim 1, wherein the distal portion of the wire body is surrounded by a polymeric sheath.

8. An intravascular guidewire system as recited in claim 7, wherein the polymeric sheath extends beyond a distal end of the wire body to define a flexible tubular extension sleeve.

9. An intravascular guidewire system as recited in claim 7, wherein a clearance gap exist between the polymeric sheath and a distal-most section of the wire body.

10. An intravascular guidewire system as recited in claim 7, wherein the polymeric sheath is formed from heat shrinkable polytetrafluoroethylene tubing.

11. An intravascular guidewire system as recited in claim 7, wherein a plurality of spaced apart radiopaque markers are disposed within the tubular extension sleeve.

12. An intravascular guidewire system as recited in claim 11, wherein the radiopaque markers include at least three generally cylindrical markers formed from a platinum and iridium alloy.

13. An intravascular guidewire system as recited in claim 1, wherein the torquing sheath is constructed from plural helically wound layers of coiled wire filament.

14. An intravascular guidewire system as recited in claim 13, wherein the torquing sheath is constructed from an inner helically wound coil layer wound in a first direction and an outer helically wound coil layer wound in a second direction.

15. An intravascular guidewire system as recited in claim 1, wherein a tubular sleeve formed from a polymeric material is heat shrunk about the outer periphery of a proximal portion of the torquing sheath.

16. An intravascular guidewire system as recited in claim 15, wherein the tubular sleeve extends along about 15% to 40% of the length of the torquing sheath.

17. An intravascular guidewire system as recited in claim 1, wherein the curved distal portion of the torquing sheath has a reduced diameter to provide the curved distal portion with added flexibility and reduced rigidity relative to the remainder of the torquing sheath.

18. An intravascular guidewire system as recited in claim 17, wherein the reduction in diameter is accomplished by a chemical etching process.

19. An intravascular guidewire system as recited in claim 1, wherein the distal portion of the torquing sheath is electrically treated so as to set the curvature therefor.

20. An intravascular guidewire system as recited in claim 1, wherein the distal portion of the torquing sheath is defined by a flexible nosepiece having a radius of curvature.

21. An intravascular guidewire system as recited in claim 20, wherein the flexible nosepiece is formed from a polymeric material and includes a proximal portion for receiving the distal end of the torquing sheath.

22. An intravascular guidewire system as recited in claim 1, further comprising a rotatable ablation device including a drive shaft having an interior lumen and carrying an abrasive crown for ablating stenotic material, the interior lumen of the drive shaft being dimensioned and configured to receive the core wire.

23. An intravascular guidewire system as recited in claim 22, wherein a monolithic tubular liner formed from a lubricious material is disposed within the interior lumen of the drive shaft to reduce friction between the core wire and the drive shaft.

24. An intravascular guidewire system as recited in claim 22, wherein a three layer tubular liner is disposed within the interior lumen of the drive shaft, the liner having an outer layer formed from a material that bonds well to the interior surface of the drive shaft and an inner layer formed from a lubricious material that reduces friction between the guidewire and the drive shaft.

25. An intravascular guidewire system as recited in claim 22, wherein the drive shaft has an eccentric section carrying the abrasive crown and a conically tapered section proximal to an eccentric shaft section.

26. An intravascular guidewire comprising:

a core wire defined by an elongated wire body having opposed proximal and distal ends, a distal portion of the wire body being surrounded by a polymeric sheath, the polymeric sheath extending beyond the distal end of the wire body to define a flexible tubular extension sleeve.

27. An intravascular guidewire as recited in claim 26, wherein the wire body is formed from a monofilament structure.

28. An intravascular guidewire as recited in claim 26, wherein the wire body is formed from a metal alloy having shape memory characteristics.

29. An intravascular guidewire as recited in claim 28, wherein the distal portion of the wire body is heat-treated in such a manner so as to relieve the shape memory characteristics associated therewith.

30. An intravascular guidewire as recited in claim 26, wherein the distal portion of the wire body is conically tapered in a center-less grinding process.

31. An intravascular guidewire as recited in claim 26, wherein a clearance gap exist between the polymeric sheath and a distal-most section of the wire body.

32. An intravascular guidewire as recited in claim 26, wherein the polymeric sheath is formed from heat shrinkable polytetrafluoroethylene tubing.

33. An intravascular guidewire as recited in claim 26, wherein a plurality of spaced apart radiopaque markers are disposed within the tubular extension sleeve.

34. An intravascular guidewire as recited in claim 33, wherein the radiopaque markers include at least three generally cylindrical markers formed from a platinum and iridium alloy.

35. An intravascular guidewire as recited in claim 26, wherein a plug is provided at the distal end of the tubular extension sleeve.

36. An intravascular guidewire as recited in claim 26, wherein a coiled radiopaque marker wire is disposed within the tubular extension sleeve.

37. An intravascular guidewire comprising:

a core wire defined by an elongated wire body having opposed proximal and distal ends, the wire body formed from a metal alloy having shape memory characteristics, a distal portion of the wire body being heat treated in such a manner so to relieve the shape memory characteristics associated therewith.

38. An intravascular guidewire as recited in claim 37, wherein a polymeric sheath surrounds a distal portion of the wire body.

39. An intravascular guidewire as recited in claim 38, wherein the polymeric sheath extends beyond the distal end of the wire body to define a flexible tubular extension sleeve.

40. An intravascular guidewire as recited in claim 38, wherein the polymeric sheath is formed from heat shrinkable polytetrafluoroethylene tubing.

41. An intravascular guidewire as recited in claim 39, wherein a plurality of spaced apart radiopaque markers are disposed within the tubular extension sleeve.

42. An intravascular guidewire as recited in claim 41, wherein the radiopaque markers include at least three generally cylindrical markers formed from a platinum and iridium alloy.

43. An intravascular guidewire as recited in claim 39, wherein a coiled radiopaque marker wire is disposed within the tubular extension sleeve.

44. An intravascular guidewire as recited in claim 39, wherein a plug is provided at the distal end of the tubular extension sleeve.

45. An intravascular guidewire as recited in claim 39, wherein the distal portion of the wire body is conically tapered in a center-less grinding process.

46. An intravascular guidewire as recited in claim 45, wherein a clearance gap exist between the polymeric sheath and a distal-most section of the wire body.

47. An intravascular torquing sheath comprising:

an elongated body constructed from plural helically wound layers of coiled wire filament, including an inner helically wound coil layer wound in a first direction and an outer helically wound coil layer wound in a second direction, and having a curved distal portion.

48. An intravascular torquing sheath as recited in claim 47, wherein the curved distal portion of the torquing sheath has a reduced diameter to provide added flexibility and reduced rigidity.

49. An intravascular torquing sheath as recited in claim 48, wherein the reduction in diameter is accomplished by a chemical etching process.

50. An intravascular torquing sheath as recited in claim 47, wherein the distal portion of the torquing sheath is electrically treated so as to set the curvature therefor.

51. An intravascular torquing sheath as recited in claim 47, wherein the curved distal portion of the torquing sheath is defined by a flexible nosepiece having a radius of curvature.

52. An intravascular torquing sheath as recited in claim 51, wherein the flexible nosepiece is formed from a polymeric material and includes a proximal portion for receiving the distal end of the torquing sheath.

53. An intravascular torquing sheath as recited in claim 47, wherein a tubular sleeve formed from a polymeric material is heat shrunk about the outer periphery of a proximal portion of the torquing sheath.

54. An intravascular torquing sheath as recited in claim 53, wherein the tubular sleeve extends along about 15% to 40% of the length of the torquing sheath.

55. An intravascular torquing sheath as recited in claim 47, wherein a spherical member is secured to a distal end of the outer coil layer to render the distal end of the torquing sheath atraumatic to blood vessels.

56. An intravascular torquing sheath as recited in claim 55, wherein the spherical member is formed at least in part from a precious metal.

57. A method of forming an intravascular guidewire, comprising the steps of:

a) providing an elongated wire body formed from a material having shape memory characteristics; and

b) treating a distal portion of the wire body in a manner so as to relieve the shape memory characteristics associated therewith.

58. A method according to claim 57, wherein the step of treating a distal portion of the wire body includes heating a distal portion in an enclosure containing an inert gas for about thirty minutes at approximately 300°

F.

59. A method according to claim 57, further comprising the step of heat shrinking a polymeric tube over a distal portion of the wire body.

60. A method of forming an intravascular torquing sheath, comprising the steps of:

a) providing an elongated body formed from plural helically wound coil wire layers;

b) positioning a distal portion of the elongated body over a cylindrical forming mandrel having a desired radius of curvature; and

c) delivering an electrical current through the distal portion of the elongated body such that the distal portion assumes the curvature of the forming mandrel.

61. A method according to claim 60, further comprising the steps of reducing the outer diameter of the distal portion of the torquing sheath to enhance the flexibility thereof.

62. A method according to claim 61, wherein the step of reducing the outer diameter of the distal portion of the torquing sheath includes masking the distal portion of the torquing sheath and applying a chemical etching agent thereto.