Guidewire for crossing occlusions or stenosis

• US 6,824,550 B1
• Filed: 08/22/2000
• Issued: 11/30/2004
• Est. Priority Date: 04/06/2000
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Norborn Medical, Inc. (Boston Scientific Corporation)
• Inventors: Chechelski, Victor, Noriega, Gerardo V., Sudaria, Rudolfo
• Primary Examiner(s): Reip, David O.
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US09/644,201
• Time in Patent Office: 1,561 Days
• Field of Search: 606/159, 606/167, 606/168, 606/170, 606/171, 606/180, 606/113, 606/114, 606/127, 604/523
• US Class Current: 606/159
• 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 17/3421 Cannulas
• CPC Class Codes: A61B 17/50 Instruments, other than pincettes or toothpicks, for removing foreign bodies from the human body locating otherwise A61B5/06; locating by radiation A61B6/00; removing calculi A61B17/22; from the eyes A61F9/00709
• 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 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/320004 abrasive

Abstract

Systems and methods for crossing stenosis, partial occlusions, or complete occlusions within a body lumen. The systems generally include an elongate member such as a hollow guidewire that houses a rotatable and translatable drive shaft. The drive shaft typically has a distal portion that is advanced to create a path in the occlusive material that is large enough to allow the hollow guidewire to cross the occlusive material.

Claims

1. An assembly for crossing occlusive or stenotic material, the assembly comprising:

a flexible, hollow guidewire comprising an axial passage, an outer diameter between approximately 0.009 inches and 0.035 inches, and a torqueability and pushability to be advanced through a vascular body lumen without the need of a separate guidewire;

a housing removably coupled to a proximal end of the flexible, hollow guidewire; and

a drive shaft rotatably and translatably extending through the axial passage of the guidewire;

wherein the drive shaft comprises a distal tip that can be rotated and advanced to create a path that is larger than the outer diameter of the guidewire through the occlusive or stenotic material.

2. The assembly of claim 1 further comprising a detachable motor coupled to a proximal end of the drive shaft that can impart a rotational movement to the distal tip of the drive shaft.

3. The assembly of claim 1 wherein a proximal end of the drive shaft can be manually rotated.

4. The assembly of claim 1 wherein the distal tip is flattened and twisted.

5. The assembly of claim 1 wherein the distal tip has a width that is larger than the width of the drive shaft.

6. The assembly of claim 1 wherein a distal end of the hollow guidewire is steerable.

7. The assembly of claim 1 wherein the housing comprises an actuator, wherein the drive shaft defines a longitudinal axis, and wherein movement of the actuator moves the drive shaft along the longitudinal axis.

8. The assembly of claim 7 wherein the actuator advances the drive shaft up to 5 centimeters beyond a distal end of the hollow guidewire.

9. The assembly of claim 1 wherein the housing comprises an infusion or aspiration port in communication with the axial passage of the hollow guidewire.

10. The assembly of claim 1 wherein the hollow guidewire is maintained in a substantially stationary position while the drive shaft is rotated and advanced.

11. The assembly of claim 1 wherein the distal tip of the drive shaft is radio-opaque.

12. The assembly of claim 1 wherein the drive shaft has riflings which facilitate proximal transportation of a removed occlusive or stenotic material.

13. The assembly of claim 1 further comprising a support system having a distal end, wherein the hollow guidewire passes through the support system such that the distal tip is positioned beyond the distal end of the hollow guidewire and support system.

14. The assembly of claim 13 wherein the support system comprises placing means disposed near the distal end for entering or directing the distal end of the support system within the body lumen.

15. The assembly of claim 13 wherein the hollow guidewire is advanceable through the vascular body lumen without the use of the support system.

16. The assembly of claim 1 wherein the drive shaft defines a longitudinal axis, wherein the distal tip is deflected off the longitudinal axis.

17. A guidewire system for passing through an occlusion or stenosis, the system comprising:

a flexible, hollow guidewire having a steerable distal end, a proximal end, and a lumen therebetween, wherein the hollow guidewire has an outer diameter between approximately 0.009 inches and 0.035 inches and a torqueability and pushability to be advanced through a body lumen without the need of a separate guidewire;

a drive shaft movably disposed within the hollow guidewire, the drive shaft having a longitudinal axis, a proximal end, and a distal tip portion;

a rotating mechanism removably coupled to the proximal end of the drive shaft; and

an actuator coupled to the drive shaft for controlling the axial movement of the drive shaft;

wherein the activation of the actuator advances the rotatable drive shaft from a retracted position to an extended position, wherein the rotating distal tip portion in an extended position can create a path through the occlusion or stenosis.

18. The system of claim 17 wherein the distal tip portion is flattened and twisted.

19. The system of claim 17 wherein the distal tip portion creates a path forward of the hollow guidewire that is at least as large as the outer diameter of the hollow guidewire.

20. The system of claim 17 wherein the distal lip portion creates a path forward of the hollow guidewire that is no larger than the outer diameter of the hollow guidewire.

21. The system of claim 17 wherein the distal tip portion comprises a plurality of wires unconnected at their ends, a plurality of wires unconnected at their ends, spiral with a blunt tip, or a loop.

22. The system of claim 17 wherein the rotating mechanism and actuator are coupled together such that the drive shaft is rotated and advanced simultaneously.

23. The system of claim 17 wherein the rotating mechanism and actuator are independently rotated and advanced.

24. The system of claim 17 wherein the rotating mechanism is removably attached to the drive shaft.

25. The system of claim 17 wherein the lumen of the hollow guidewire is configured to aspirate fluids and debris from or infuse fluids into the occlusion or stenosis.

26. A system for crossing an occlusion or stenosis within a body lumen, the system comprising:

a flexible, hollow guidewire having a proximal end, a distal end, and an axial passage extending to a distal tip at the distal end, wherein the guidewire has an outer diameter between approximately 0.009 inches and 0.035 inches and a torqueability and pushability of be advanced through a vascular body lumen;

a drive shaft rotatably and translatably receivable in the axial passage of the guidewire;

a housing removably coupled to the proximal end of the flexible, hollow guidewire; and

a flattened and twisted distal tip attached to the drive shaft that can create a path in front of the distal end of the guidewire, wherein the drive shaft and distal tip are moveable between an axially retracted configuration and an axially extended configuration.

27. The system of claim 26 wherein the distal tip in the axially retracted configuration has a profile no larger than that of the distal tip.

28. The system of claim 26 wherein the distal tip is sharpened.

29. The system of claim 26 wherein the distal tip comprises at least two turns.

30. The system of claim 26 wherein the hollow guidewire has a steerable distal end.

31. The system of claim 26 further comprising a rotating mechanism coupled to a proximal end of the drive shaft to facilitate rotation of the drive shaft.

32. The system of claim 31 wherein the rotating mechanism is detachable from a proximal end of the drive shaft.

38. The kit of claim 31 wherein the support or access system comprises an atherectomy catheter, support catheter, a balloon angioplasty catheter, a stenting catheter, infusion catheter, rotational catheter, extractional catheter, or a guiding catheter.

39. The kit of claim 38 further comprising a second guidewire, wherein the support or access system is advanced through the body lumen over the second guidewire.

33. A kit comprising:

a flexible, hollow guidewire having an axial passage, an outer diameter between approximately 0.009 inches and 0.035 inches, and a torqueability and pushability to be advanced through a body lumen without the need of a separate guidewire;

a rotatable drive shaft having a shaped distal tip, the rotatable drive shaft being removably received within the passage of the hollow guidewire;

a housing that is removably coupleable to a proximal end of the hollow guidewire;

instructions for use in passing through occlusions in a body lumen comprising rotating the drive shaft within the steerable hollow guidewire and advancing the drive shaft into the occlusive material to create a path through the occlusive material; and

a package adapted to contain the hollow guidewire, rotatable drive shaft, and the instructions for use.

34. The kit of claim 33 wherein rotation of the shaped distal tip creates a profile that is at least as large as the outer diameter of the hollow guidewire.

35. The kit of claim 33 wherein rotation of the shaped distal tip creates a profile that is no larger than the outer diameter of the hollow guidewire.

36. The kit of claim 33 wherein the hollow guidewire has a steerable distal portion.

37. The kit of claim 33 further comprising a support or access system, wherein the support or access system is sized to removably receive the hollow guidewire and position a distal end of the hollow guidewire adjacent the occlusion.

40. The kit of claim 33 further comprising a power supply and a motor, wherein the motor can be coupled to a proximal end of the rotatable drive shaft so as to rotate the drive shaft.

41. The kit of claim 40 further comprising attachment mechanism for detachably coupling the motor to the drive shaft.

42. The kit of claim 41 wherein the motor is movably housed within a housing, wherein the housing is removing coupled to the hollow guidewire through a luer.

43. The kit of claim 40 wherein the power supply comprises a plastic sheath cover.

44. An assembly for crossing occlusive or stenotic material, the assembly comprising:

a flexible guidewire comprising an axial passage, an outer diameter between approximately 0.009 inches and 0.035 inches, and a torqueability and pushability to be advanced through a body lumen without the need of a separate guidewire;

a housing removably coupled to a proximal end of the flexible guidewire; and

a drive shaft movably extending through the axial passage of the guidewire;

wherein the drive shaft comprises a distal tip that extends beyond the guidewire to create a path through the occlusive or stenotic material.

45. An assembly for crossing occlusive or stenotic material, the assembly comprising:

a guidewire comprising an axial passage, an outer diameter between approximately 0.009 inches and 0.035 inches, and a torqueability and pushability to be advanced through a body lumen without the need of a separate guidewire;

a housing removably coupled to a proximal end of the flexible guidewire; and

a drive shaft movably extending through the axial passage of the guidewire;

wherein the drive shaft comprises a distal tip that extends distally beyond the guidewire,

wherein the drive shaft may be oscillated or rotated to create a path through the occlusive or stenotic material.