Crossing occlusions in blood vessels

• US 8,202,246 B2
• Filed: 02/04/2009
• Issued: 06/19/2012
• Est. Priority Date: 02/05/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: BridgePoint Medical, Inc. (Boston Scientific Corporation)
• Inventors: Kugler, Chad John, Olson, Matthew Jonathan, Olson, Ross Arlen, Robinson, David B., Jacobs, Peter Alan
• Primary Examiner(s): Koharski, Christopher D
• Application Number:
  US12/320,792
• Publication Number:
  US 20090209910A1
• Time in Patent Office: 1,231 Days
• Field of Search: 600/585, 604/164.01, 604/164.11, 604/264, 604/272, 604/523, 604158-161, 604/103.1, 606/108
• US Class Current: 604/103.1
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• 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 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/00438 connectable to a finger
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22048 Balloons
• 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: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• 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 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

The present disclosure is directed a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method may include providing a first intravascular device having a distal portion and at least one aperture and positioning the distal portion of the first intravascular device in the vascular wall. The method may further include providing a reentry device having a body and a distal tip, the distal tip having a natural state and a compressed state and inserting the distal tip, in the compressed state, in the distal portion of the first intravascular device. The method may further include advancing the distal tip, in the natural state, through the at least one aperture of the first intravascular device.

Claims

1. A method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the method comprising:

positioning a distal portion of a first intravascular device in the vascular wall, the first intravascular device including a first aperture, a second aperture, a first radiopaque marker, and a second radiopaque marker, the first aperture being longitudinally offset from the second aperture with the first aperture located proximal the second aperture, the first radiopaque marker being located between the first aperture and the second aperture, the second radiopaque marker being located distal the second aperture;

inserting a distal end of a reentry device, in a compressed state, in the distal portion of the first intravascular device;

positioning the distal end of the reentry device proximal the first radiopaque marker of the first intravascular device;

rotating the reentry device until the distal end of the reentry device, in a natural state, enters the first aperture of the first intravascular device;

positioning the distal end of the reentry device proximal the second radiopaque marker of the first intravascular device and distal the first radiopaque marker of the first intravascular device;

rotating the reentry device until the distal end of the reentry device, in the natural state, enters the second aperture of the first intravascular device; and

advancing the distal end, in a natural state, through the second aperture of the first intravascular device.

2. The method of claim 1, wherein when the distal end is in the natural state, the distal end forms an angle with a body of the reentry device.

3. The method of claim 2, wherein the angle is between about 120 degrees and about 150 degrees.

4. The method of claim 1, further including directing the distal end of the reentry device towards the vascular lumen and into contact with an intimal layer of the vascular wall.

5. The method of claim 1, wherein the reentry device includes a body, the body defining a device lumen, and a core located in the device lumen that is movable relative to the device lumen.

6. The method of claim 5, further including moving a distal tip of the core of the reentry device beyond the distal end of the reentry device.

7. The method of claim 5, further comprising piercing an intimal layer of the vascular wall with the reentry device, and advancing the distal end of the reentry device into the vascular lumen.

8. The method of claim 7, wherein the core includes a penetrator, and wherein the penetrator is configured to pierce an intimal layer of the vascular wall before the distal end of the reentry device is advanced into the vascular lumen.

9. The method of claim 1, further including:

positioning a second intravascular device in the vascular wall prior to positioning the distal portion of the first intravascular device in the vascular wall; and

advancing a distal portion of the second intravascular device in the vascular wall beyond the occlusion.

10. The method of claim 9, further including advancing a guidewire through a lumen of the second intravascular device, and removing the second intravascular device from the vascular wall while leaving the guidewire in the vascular wall.

11. The method of claim 10, wherein positioning the distal portion of the first intravascular device in the vascular wall comprises advancing the first intravascular device over the guidewire.

12. The method of claim 11, further comprising withdrawing the guidewire from a guidewire lumen of the first intravascular device.

13. The method of claim 12, further comprising advancing at least a portion of the reentry device into the guidewire lumen of the first intravascular device.

14. The method of claim 13, further comprising removing the first intravascular device from the vascular wall while a distal portion of the reentry device is extending through an intimal portion of the vascular wall.

15. The method of claim 14, further comprising advancing a therapy catheter over the reentry device.

34. The method of claim 1, further including determining whether the distal end of the reenty device is directed toward the vascular lumen or directed away from the vascular lumen, wherein determining whether the distal end of the reentry device is directed toward the vascular lumen or directed away from the vascular lumen comprises viewing the distal end of the reentry device using fluoroscopy.

35. The method of claim 1, further comprising advancing the distal end of the reentry device through an intimal portion of the vascular wall if it is determined that the distal end of the reentry device is directed toward the vascular lumen.

36. The method of claim 1, further comprising advancing the distal end of the reentry device into the vascular lumen if it is determined that the distal end of the reentry device is directed toward the vascular lumen.

37. The method of claim 1, further comprising withdrawing the distal end of the reentry device into the first intravascular device if it is determined that the distal end of the reentry device is directed away from the vascular lumen.

38. The method of claim 1, further comprising determining whether the distal end of the reentry device, advanced through the other of the first aperture and the second aperture, is directed toward the vascular lumen or directed away from the vascular lumen.

39. The method of claim 1, further comprising withdrawing one of a guidewire and the reentry device from a guidewire lumen of the first intravascular device and advancing the other of the guidewire and the reentry device into the guidewire lumen of the first intravascular device.

16. A method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the method comprising:

positioning a distal portion of a first intravascular device in the vascular wall;

inserting a distal end of a reentry device in the distal portion of the first intravascular device, the reentry device including a penetrator that extends distally beyond a distal surface of a body of the reentry device;

positioning the distal end of the reentry device proximate a first aperture of the first intravascular device;

rotating the reentry device until the distal end of the reentry device enters the first aperture of the first intravascular device;

positioning the distal end of the reentry device proximate a second aperture of the first intravascular device;

rotating the reentry device until the distal end of the reentry device enters the second aperture of the first intravascular device; and

advancing the penetrator through the second aperture of the first intravascular device.

17. The method of claim 16, further comprising contacting an intimal layer of the vascular wall with the penetrator.

18. The method of claim 17, further comprising contacting the intimal layer of the vascular wall with the distal end.

19. The method of claim 18, wherein the penetrator contacts the intimal layer of the vascular wall before the distal surface of the body of the reentry device contacts the intimal layer of the vascular wall.

20. The method of claim 16, further comprising piercing the intimal layer of the vascular wall with the penetrator.

21. The method of claim 20, further comprising piercing the intimal layer of the vascular wall with the distal end.

22. The method of claim 21, wherein the penetrator pierces the intimal layer of the vascular wall before the distal surface of the body pierces the intimal layer of the vascular wall.

23. The method of claim 16, wherein the reentry device has a core including the penetrator, the core being movable relative to the body of the reentry device, and further including moving the core relative to the body.

24. The method of claim 23, wherein moving the core relative to the body comprises moving a distal end of the core beyond the distal surface of the body.

25. The method of claim 16, wherein the penetrator is fixed relative to the body.

26. The method of claim 16, further comprising advancing the distal end of the reentry device into the vascular lumen.

27. The method of claim 16, wherein the first intravascular device includes a second aperture.

28. The method of claim 27, wherein the first aperture is located proximal the second aperture.

29. The method of claim 16, further including determining whether the distal end of the reenty device is directed toward the vascular lumen or directed away from the vascular lumen, wherein determining whether the distal end of the reentry device is directed toward the vascular lumen or directed away from the vascular lumen comprises viewing the distal end of the reentry device using fluoroscopy.

30. The method of claim 29, further comprising advancing the distal end tip of the reentry device through an intimal portion of the vascular wall if it is determined that the distal end tip of the reentry device is directed toward the vascular lumen.

31. The method of claim 29, further comprising advancing the distal end tip of the reentry device into the vascular lumen if it is determined that the distal end tip of the reentry device is directed toward the vascular lumen.

32. The method of claim 29, further comprising withdrawing the distal end tip of the reentry device into the first intravascular device if it is determined that the distal end tip of the reentry device is directed away from the vascular lumen.

33. The method of claim 16, further comprising withdrawing one of a guidewire and the reentry device from a guidewire lumen of the first intravascular device and advancing the other of the guidewire and the reentry device into the guidewire lumen of the first intravascular device.

40. A method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the method comprising:

positioning a distal portion of a first intravascular device in the vascular wall;

inserting a distal end of a reentry device in the distal portion of the first intravascular device;

positioning the distal end of the reentry device proximate a first aperture of the first intravascular device;

rotating the reentry device until the distal end of the reentry device enters the first aperture of the first intravascular device;

positioning the distal end of the reentry device proximate a second aperture of the first intravascular;

rotating the reentry device until the distal end of the reentry device enters the second aperture of the first intravascular device; and

advancing the distal end through the second aperture of the first intravascular device.

41. The method of claim 40, wherein the distal end has a natural state such that when the distal end is in the natural state, the distal end forms an angle with a body of the reentry device.

42. The method of claim 41, wherein the angle is between about 120 degrees and about 150 degrees.

43. The method of claim 40, further including directing the distal end of the reentry device towards the vascular lumen and into contact with an intimal layer of the vascular wall.

44. The method of claim 40, wherein the reentry device includes a body, the body defining a device lumen.

45. The method of claim 44, further comprising piercing an intimal layer of the vascular wall with the reentry device, and advancing the distal end of the reentry device into the vascular lumen.

46. The method of claim 45, wherein the reentry device includes a penetrator, and wherein the penetrator is configured to pierce the intimal layer of the vascular wall before the distal end of the reentry device is advanced into the vascular lumen.

47. The method of claim 40, further comprising advancing the distal end of the reentry device into the vascular lumen if it is determined that the distal end of the reentry device is directed toward the vascular lumen.

48. The method of claim 40, further comprising withdrawing the distal end of the reentry device into the first intravascular device if it is determined that the distal end of the reentry device is directed away from the vascular lumen.

49. The method of claim 40, further comprising withdrawing one of a guidewire and the reentry device from a guidewire lumen of the first intravascular device and advancing the other of the guidewire and the reentry device into the guidewire lumen of the first intravascular device.

50. The method of claim 40, further including:

positioning a second intravascular device in the vascular wall prior to positioning the distal portion of the first intravascular device in the vascular wall; and

advancing a distal portion of the second intravascular device in the vascular wall beyond the occlusion.

51. The method of claim 50, further including advancing a guidewire through a lumen of the second intravascular device, and removing the second intravascular device from the vascular wall while leaving the guidewire in the vascular wall.

52. The method of claim 40, wherein the first intravascular device includes a first radiopaque marker and a second radiopaque marker, the first aperture being longitudinally offset from the second aperture with the first aperture located proximal the second aperture, the first radiopaque marker being located between the first aperture and the second aperture, the second radiopaque marker being located distal the second aperture.

53. The method of claim 40, further including a penetrator located at a distal tip of the distal end.