Methods and apparatus for crossing occlusions in blood vessels

• US 20090270890A1
• Filed: 04/27/2009
• Published: 10/29/2009
• Est. Priority Date: 04/28/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: BridgePoint Medical, Inc. (Boston Scientific Corporation)
• Inventors: Kugler, Chad John, Olson, Ross Arlen, Robinson, David Bryan, Olson, Matthew Jonathan, Jacobs, Peter Alan
• Granted Patent: US 8,172,863 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• 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 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2090/031 torque limiting
• CPC Class Codes: A61B 34/76 Manipulators having means for providing feel, e.g. force or tactile feedback

Abstract

Exemplary embodiments of the present disclosure are directed to a device for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The device includes an intravascular device including a shaft having a distal end and a proximal end. The device further includes a handle assembly fixed about the proximal end of the shaft, the handle assembly including a first portion. Further rotation of the first portion in a first direction about a longitudinal axis of the shaft causes rotation of the shaft in the first direction when a torque applied by the first portion to the shaft is below a first maximum torque. Still further, rotation of the first portion in the first direction about a longitudinal axis of the shaft does not cause rotation of the shaft in the first direction when the torque applied by the first portion to the shaft is equal to or above the first maximum torque.

Claims

1. A device for facilitating treatment of a blood vessel, the device comprising:

a shaft having a distal end and a proximal end;

a handle assembly fixed about the proximal end of the shaft, the handle assembly including a first portion, wherein rotation of the first portion in a first direction about a longitudinal axis of the shaft causes rotation of the shaft in the first direction when a torque applied by the first portion to the shaft is below a first maximum torque; and

wherein rotation of the first portion in the first direction about the longitudinal axis of the shaft does not cause rotation of the shaft in the first direction when the torque applied by the first portion to the shaft is above the first maximum torque.

2. The device of claim 1, wherein the handle assembly provides an audible indication when the torque applied by the first portion to the shaft is above the first maximum torque.

3. The device of claim 2, wherein the audible indication comprises a clicking sound.

4. The device of claim 1, wherein the handle assembly provides a tactile indication when the torque applied by the first portion to the shaft is above the first maximum torque.

5. The device of claim 4, wherein the tactile indication comprises vibration of the first portion of the handle assembly.

6. The device of claim 1, wherein rotation of the first portion in a second direction about the longitudinal axis of the shaft causes rotation of the shaft in the second direction when a torque applied by the first portion to the shaft is below a second maximum torque.

7. The device of claim 6, wherein rotation of the first portion in the second direction about the longitudinal axis of the shaft does not cause rotation of the shaft in the second direction when the torque applied by the first portion to the shaft is above the second maximum torque.

8. The device of claim 6, wherein the second maximum torque is greater than the first maximum torque.

9. The device of claim 6, wherein the handle assembly provides an audible indication when the torque applied by the first portion to the shaft is above the second maximum torque.

10. The device of claim 9, wherein the audible indication comprises a clicking sound.

11. The device of claim 6, wherein the handle assembly provides a tactile indication when the torque applied by the first portion to the shaft is above the second maximum torque.

12. The device of claim 11, wherein the tactile indication comprises vibration of the first portion of the handle assembly.

13. The device of claim 1, further including a torque limiting mechanism, the torque limiting mechanism including a set of camming elements.

14. The method of claim 13, wherein the set of camming elements includes a first camming element, a second camming element disposed between the first camming element and a third camming element, and the third camming element is fixed to the first portion.

15. The device of claim 14, wherein the second camming element is rotatable about the longitudinal axis relative to the first camming element and the third camming element.

16. The device of claim 14, wherein the first camming element defines at least one ramped surface.

17. The device on claim 14, wherein the second camming element defines at least one recess configured to receive the at least one ramped surface of the first camming element.

18. The device of claim 14, wherein the handle assembly further includes:

a second portion including a handle axle; and

a proximal cap threadedly engaged to the handle axle.

19. The device of claim 18, wherein a portion of the handle axle is disposed within the first camming element.

20. The device of claim 18, wherein the second portion of the handle assembly further includes a collet configured to secure the shaft to the second portion of the handle assembly.

21. The device of claim 18, wherein the first camming element defines an opening configured to receive a portion of the handle axle.

22. The device of claim 21, wherein the handle axle includes a plurality of splines, and wherein a portion of the plurality of splines is disposed within the first camming element.

23. The device of claim 14, wherein the first portion of the handle assembly includes a handle housing threadedly engaged to the third camming element.

24. The device of claim 23, wherein the third camming element is a distal cap.

25. The device of claim 14, wherein the second camming element defines at least one ramped surface.

26. The device on claim 25, wherein the third camming element defines at least one recess configured to receive the at least one ramped surface of the second camming element.

27. A handle assembly for use with a medical device shaft, the handle assembly including:

a first portion, wherein rotation of the first portion in a first direction about a longitudinal axis of the shaft causes rotation of the shaft in the first direction when a torque applied by the first portion to the shaft is below a first maximum torque;

a torque limiting mechanism in communication with the first portion; and

wherein rotation of the first portion in the first direction about the longitudinal axis of the shaft does not cause rotation of the shaft in the first direction when the torque applied by the first portion to the shaft is equal to or above the first maximum torque.

28. The device of claim 27, wherein rotation of the first portion in a second direction about the longitudinal axis of the shaft causes rotation of the shaft in the second direction when a torque applied by the first portion to the shaft is below a second maximum torque.

29. The device of claim 28, wherein rotation of the first portion in the second direction about the longitudinal axis of the shaft does not cause rotation of the shaft in the second direction when the torque applied by the first portion to the shaft is above the second maximum torque.

30. The device of claim 28, wherein the second maximum torque is different than the first maximum torque.

31. The device of claim 27, wherein the torque limiting mechanism includes a set of camming elements.

32. The device of claim 31, wherein the torque limiting mechanism includes a first camming element, a second camming element disposed between the first camming element and a third camming element, and the third camming element is fixed to the first portion.

33. The device of claim 32, wherein the second camming element is rotatable about the longitudinal axis relative to the first camming element and the third camming element.

34. The device of claim 32, wherein the handle assembly further includes:

a second portion including a handle axle; and

a proximal cap threadedly engaged to the handle axle.

35. The device of claim 30, wherein the first portion of the handle assembly includes a handle housing threadedly engaged to the third camming element.

36. A device for facilitating treatment of a blood vessel, the device comprising:

a shaft having a distal end and a proximal end;

a handle assembly disposed about the shaft; and

the handle assembly comprising a first portion and a torque limiting mechanism coupling the first portion to the shaft;

wherein the torque limiting mechanism allows relative movement between the first portion and the shaft when the first portion is being rotated in a first direction and a torque applied to the shaft has exceeded a first maximum torque.

37. The device of claim 36, wherein the torque limiting mechanism allows relative movement between the first portion and the shaft when the first portion is being rotated in a second direction and the torque applied to the shaft has exceeded a second maximum torque.

38. The device of claim 37, wherein the second maximum torque is different than the first maximum torque.

39. The device of claim 37, wherein:

the shaft comprises a left hand wound coil;

the first direction is a clockwise direction; and

the first maximum torque is greater than the second maximum torque.

40. The device of claim 37, wherein:

the shaft comprises a right hand wound coil;

the second direction is a counterclockwise direction; and

the second maximum torque is greater than the first maximum torque.

41. The device of claim 36, wherein the shaft comprises a coil.

42. The device of claim 41, further comprising a distal tip fixed to a distal end of the coil and a proximal hub fixed to a proximal end of the coil.

43. The device of claim 36, wherein the torque limiting mechanism transfers torque between the first portion and the shaft when the first portion is being rotated in a first direction and the torque applied to the shaft is less than or equal to the first maximum torque.

44. The device of claim 36, wherein the torque limiting mechanism comprises a first camming element.

45. The device of claim 44, wherein the first camming element is coupled to the shaft so that the first camming element is not free to rotate relative to the shaft.

46. The device of claim 44, wherein:

the first camming element comprises a first ramp; and

the first ramp comprises a first ramped surface and a first face.

47. The device of claim 46, wherein the torque limiting mechanism comprises a second camming element.

48. The device of claim 47, wherein:

the second camming element comprises a first ramp engaging surface and a second ramp; and

the second ramp comprises a second ramped surface and a second face.

49. The device of claim 48, wherein the torque limiting mechanism comprises a cap fixed to the first portion, the cap comprising a second ramp engaging surface.

50. The device of claim 49, wherein:

the first ramp engaging surface engages the first ramped surface when the first portion is rotated in the first direction; and

the second ramp engaging surface engages the second ramped surface when the second portion is rotated in a second direction.

51. The device of claim 50, wherein:

the first face contacts a first stop when the first portion is rotated in the second direction; and

the second face contacts a second stop when the second portion is rotated in the first direction.

52. The device of claim 51, wherein the first stop comprises a first wall of the second camming element.

53. The device of claim 52, wherein the first wall defines a first stopping surface that is generally perpendicular to a path followed by the first face when the first face rotates about a longitudinal axis of the shaft.

54. The device of claim 53, wherein the first stopping surface defines a line that is generally parallel to the longitudinal axis of the shaft.

55. The device of claim 51, wherein the second stop comprises a second wall of the cap.

56. The device of claim 55, wherein the second wall defines a second stopping surface that is generally perpendicular to a path followed by the second face when the second face rotates about a longitudinal axis of the path.

57. The device of claim 56, wherein the second stopping surface defines a line that is generally parallel to the longitudinal axis of the shaft.

58. The device of claim 49, wherein:

the first ramp has a first shape;

the second ramp has a second shape; and

the second shape is different than the first shape.

59. The device of claim 49, wherein:

the first ramped surface has a first pitch;

the second ramped surface has a second pitch; and

the second pitch is different from the first pitch.

60. The device of claim 49, wherein:

the first ramp has a first maximum height;

the second ramp has a second maximum height; and

the second maximum height is different than the first maximum height.

61. The device of claim 49, wherein the first ramp engaging surface travels over and beyond the first ramped surface when the first portion is being rotated in the first direction and the torque applied to the shaft has exceeded the first maximum torque.

62. The device of claim 49, wherein the second ramp engaging surface travels over and beyond the second ramped surface when the second portion is being rotated in a second direction and a torque applied to the shaft has exceeded a second maximum torque.

63. The device of claim 37, wherein the first direction is a clockwise direction and the second direction is a counterclockwise direction.

64-83. -83. (canceled)