Methods and devices for crossing chronic total occlusions

• US 8,632,556 B2
• Filed: 10/21/2008
• Issued: 01/21/2014
• Est. Priority Date: 10/22/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: BridgePoint Medical, Inc. (Boston Scientific Corporation)
• Inventors: Jacobs, Peter Alan, Kugler, Chad John, Olson, Matthew Jonathan, Olson, Ross Arlen, Robinson, David B.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): Papeika, Rachel S
• Application Number:
  US12/289,154
• Publication Number:
  US 20090124899A1
• Time in Patent Office: 1,918 Days
• Field of Search: 606/127, 606/128, 606/167, 606/180, 606/170, 606/185, 606/159, 604/7, 604/8, 604/508, 604/264, 604/104, 604/510, 604/95.01
• US Class Current: 606/159
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• 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 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 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube

Abstract

The present disclosure is directed to a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method may include providing an intravascular device having a distal portion and a longitudinal axis and inserting the intravascular device into the vascular lumen. The method may further include positioning the distal portion in the vascular wall, rotating the intravascular device about the longitudinal axis, and advancing the intravascular device within the vascular wall.

Claims

1. A method of treating a blood vessel with an intravascular device, the blood vessel having a vascular wall defining a vascular lumen containing an occlusion therein, the occlusion being disposed between a proximal segment of the vascular lumen and a distal segment of the vascular lumen, the method comprising:

inserting the intravascular device into the vascular lumen, the intravascular device including a shaft defining a longitudinal axis and a tip located at a distal end of the shaft, wherein an outer diameter of the tip is greater than a diameter of the distal end of the shaft, a proximal portion of the tip tapering towards the shaft, and wherein the intravascular device defines a device lumen;

rotating the intravascular device about the longitudinal axis to produce relative motion at an interface between the tip and surrounding tissue;

advancing the tip out of the proximal segment of the vascular lumen into the vascular wall;

advancing the intravascular device within the vascular wall to establish a channel in the vascular wall extending longitudinally across the occlusion;

advancing the tip of the intravascular device into the distal segment of the vascular lumen distal of the occlusion;

positioning a guidewire through the device lumen and into the vascular lumen beyond the occlusion; and

withdrawing the intravascular device over the guidewire.

2. The method of claim 1, wherein the intravascular device is rotated at least a plurality of revolutions at a rotational speed between about 2 revolutions per minute and about 200 revolutions per minute.

3. The method of claim 2, wherein the intravascular device is rotated at a rotational speed between about 50 revolutions per minute and about 150 revolutions per minute.

4. The method of claim 1, further including stopping rotating and advancing the intravascular device when the tip of the intravascular device is advanced beyond the occlusion in the vascular lumen.

5. The method of claim 1, wherein rotating and advancing the intravascular device occur simultaneously.

6. The method of claim 1, wherein rotating the intravascular device includes rotating the entire intravascular device.

7. The method of claim 1, wherein rotating the intravascular device includes manually rotating a handle assembly positioned about the intravascular device.

8. The method of claim 1, wherein rotating the intravascular device includes rotating the intravascular device with an electric motor.

9. The method of claim 1, further including penetrating an intima of the vascular wall at a first location proximal to the occlusion in the vascular lumen and dissecting a layer of the wall.

10. The method of claim 1, further including penetrating the intima of the vascular wall at a second location distal to the occlusion in the vascular lumen.

11. The method of claim 1, further comprising positioning the tip in the vascular wall between an adventitia of the vascular wall and an intima of the vascular wall.

12. The method of claim 1, further comprising positioning the tip in the vascular wall between an adventitia of the vascular wall and the occlusion in the vascular lumen.

13. The method of claim 1, wherein the channel extends between the proximal segment and the distal segment.

14. The method of claim 1, wherein the tip has a flat distal face.

15. A method of treating a blood vessel with an intravascular device, the blood vessel having a vascular wall defining a vascular lumen containing an occlusion therein, the occlusion being disposed between a proximal segment of the vascular lumen and a distal segment of the vascular lumen, the method comprising:

inserting an intravascular device into the vascular lumen, the intravascular device having a radiopaque marker, the intravascular device including a shaft defining a longitudinal axis and a tip located at a distal end of the shaft, wherein an outer diameter of the tip is greater than a diameter of the distal end of the shaft, a proximal portion of the tip tapering towards the shaft, the tip having a flat distal face, and wherein the intravascular device defines a device lumen;

advancing the tip between the occlusion and an adventitia of the vascular wall;

rotating the intravascular device to produce relative motion at an interface between the tip and surrounding tissue;

advancing the tip between the adventitia and an intima of the vascular wall to a location distal of the occlusion;

advancing the tip into the distal segment of the vascular lumen from the location distal of the occlusion;

positioning a guidewire through the device lumen and into the vascular lumen beyond the occlusion; and

withdrawing the intravascular device over the guidewire.

16. The method of claim 15, wherein receiving visual feedback confirming the rotation of the intravascular device includes:

determining a first appearance of the radiopaque marker;

determining a second appearance of the radiopaque marker; and

alternating the radiopaque marker between the first appearance and the second appearance.

17. The method of claim 16, wherein the first appearance of the radiopaque marker includes a face having a width and a length, and the second appearance of the radiopaque marker includes an edge having the length and a thickness.

18. The method of claim 17, wherein the thickness is smaller than the length and the width.

19. The method of claim 17, wherein an area of the face is greater than an area of the edge.

20. The method of claim 15, further including positioning the tip in the vascular wall.

21. The method of claim 20, wherein positioning the tip in the vascular wall includes positioning the tip between the adventitia of the vascular wall and the intima of the vascular wall.

22. The method of claim 20, wherein positioning the tip in the vascular wall includes positioning the tip between the adventitia of the vascular wall and the occlusion in the vascular lumen.

23. The method of claim 15, further including advancing the intravascular device to establish a channel in the vascular wall extending longitudinally across the occlusion.

24. The method of claim 23, wherein the channel extends between the proximal segment and the distal segment.

25. The method of claim 15, wherein the intravascular device is rotated at least a plurality of revolutions.

26. The method of claim 25, wherein the intravascular device is rotated at a rotational speed between about 50 revolutions per minute and about 150 revolutions per minute.

27. A method of treating a blood vessel with an intravascular device, the blood vessel having a vascular wall defining a vascular lumen containing an occlusion therein, the occlusion being disposed between a proximal segment of the vascular lumen and a distal segment of the vascular lumen, the method comprising:

positioning the intravascular device proximate the occlusion, the intravascular device including a shaft defining a longitudinal axis and a tip located at a distal end of the shaft, wherein an outer diameter of the tip is greater than a diameter of the distal end of the shaft, a proximal portion of the tip transitioning toward the diameter of the shaft, the intravascular device including a handle assembly disposed about the shaft, the handle assembly having a first portion and a second portion, and wherein the intravascular device defines a device lumen;

rotating the first portion of the handle assembly relative to the second portion thus causing the handle assembly to grip the shaft at a first location along the longitudinal axis and cause rotation of the tip;

advancing the tip of the intravascular device within the vascular wall to a location within the vascular wall distal of the occlusion to establish a channel in the vascular wall extending longitudinally across the occlusion;

advancing the tip into the distal segment of the vascular lumen from the location within the vascular wall distal of the occlusion;

positioning a guidewire through the device lumen and into the vascular lumen beyond the occlusion; and

withdrawing the intravascular device over the guidewire.

28. The method of claim 27, wherein the handle assembly further includes at least one grip sleeve.

29. The method of claim 28, wherein the at least one grip sleeve is a plurality of grip sleeves.

30. The method of claim 28, wherein the at least one grip sleeve is within the handle body.

31. The method of claim 27, wherein the handle assembly is located over a proximal portion of a shaft of the intravascular device.

32. The method of claim 27, wherein the channel extends between the proximal segment and the distal segment.

33. The method of claim 27, wherein the tip has a flat distal face.

34. The method of claim 33, wherein the flat distal face includes a central aperture.

35. The method of claim 27, wherein the tip is rotated at least a plurality of revolutions.

36. The method of claim 35, wherein the tip is rotated at a rotational speed between about 50 revolutions per minute and about 150 revolutions per minute.

37. A method of treating a blood vessel with an intravascular device, the blood vessel having a vascular wall defining a vascular lumen containing an occlusion therein, the occlusion being disposed between a proximal segment of the vascular lumen and a distal segment of the vascular lumen, the method comprising:

inserting an intravascular device having a shaft with a longitudinal axis into the vascular lumen, wherein a tip is fixed to a distal end of the shaft, wherein an outer diameter of the tip is greater than a diameter of the distal end of the shaft, and a handle assembly is attached to a proximal end of the shaft, and wherein the intravascular device defines a device lumen;

positioning the tip near the occlusion;

advancing the tip between the occlusion and an adventitia of the vascular wall;

rotating the handle assembly to cause rotation of the tip about the longitudinal axis between the occlusion and the adventitia while advancing the tip to a location distal of the occlusion;

wherein rotating the handle assembly and advancing the tip occur simultaneously, the intravascular device being rotated at least a plurality of revolutions at a rotational speed between about 50 revolutions per minute and about 150 revolutions per minute;

passing the tip into the distal segment of the vascular lumen from the location distal of the occlusion;

positioning a guidewire through the device lumen and into the vascular lumen beyond the occlusion; and

withdrawing the intravascular device over the guidewire.

38. The method of claim 37, further including stopping rotating and advancing the tip when the tip of the intravascular device is advanced beyond the occlusion in the vascular lumen.

39. The method of claim 37, further including penetrating an intima of the vascular wall at a first location proximal to the occlusion in the vascular lumen and dissecting a layer of the wall.

40. The method of claim 37, wherein the shaft includes a coil having a plurality of filars wound in a helical shape, the coil extending from the distal end of the shaft to the proximal end of the shaft, the intravascular device further including a hub fixed to the proximal end of the shaft and a sleeve extending from a distal end of the shaft and covering a portion of the coil.

41. The method of claim 40, wherein the intravascular device further includes a sheath having a proximal end and a distal end, and covering a portion of the coil and a portion of the sleeve, the proximal end of the sheath located proximal to the proximal end of the sleeve, and the distal end of the sheath located proximal to the distal end of the sleeve.

42. The method of claim 40, wherein the intravascular device further includes a tube body having a proximal end and a distal end, and covering a portion of the coil and a portion of the sleeve, the distal end of the tube body extending beyond the proximal end of the sleeve, and the proximal end of the tube body is fixed to the hub.

43. The method of claim 37, wherein the handle assembly is slidably positioned about the intravascular device.

44. The method of claim 37, where the handle assembly is located about the intravascular device, the handle assembly comprising:

a handle body threadedly connected to a handle cap, the handle cap being configured to rotate relative to the handle body; and

at least one member configured to grip a shaft of the intravascular device in response to a rotation of the handle cap relative to the handle body.

45. The method of claim 37, wherein a channel extends between the proximal segment and the distal segment.

46. The method of claim 37, wherein the tip has a proximal portion that tapers towards the shaft.

47. The method of claim 37, wherein the tip has a flat distal face.