Crossing occlusions in blood vessels

• US 20090209910A1
• Filed: 02/04/2009
• Published: 08/20/2009
• 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, Ross Arlen, Olson, Matthew Jonathan, Robinson, David B., Jacobs, Peter Alan
• Granted Patent: US 8,202,246 B2
• Time in Patent Office: Days
• US Class Current: 604/103.100
• 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:

providing a first intravascular device having a distal portion and at least one aperture;

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

providing a reentry device having a body and a distal tip, the distal tip having a natural state and a compressed state;

inserting the distal tip, in the compressed state, in the distal portion of the first intravascular device; and

advancing the distal tip, in the natural state, through the at least one aperture of the first intravascular device.

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

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 tip 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 having a distal tip, and wherein the core is located in the device lumen and is movable relative to the device lumen.

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

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

8. The method of claim 7, wherein the distal tip of the core includes a penetrator, and wherein the penetrator is configured to pierce the vascular wall.

9. The method of claim 1, wherein the at least one aperture includes two apertures, and wherein the first aperture is located proximal the second aperture.

10. The method of claim 9, wherein the first intravascular device includes at least one radiopaque marker located distal the first aperture.

11. The method of claim 10, wherein the at least one radiopaque marker comprises a first radiopaque marker located between the first aperture and the second aperture, and a second radiopaque marker located distal the second aperture.

12. The method of claim 11, further including providing a flouroscopic display and positioning the distal tip of the reentry device proximal the first radiopaque marker of the first intravascular device.

13. The method of claim 12, further including rotating the reentry device until the distal tip of the reentry device enters the first aperture of the first intravascular device.

14. The method of claim 11, further including providing a flouroscopic display and positioning the distal tip 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.

15. The method of claim 14, further including rotating the reentry device until the distal tip of the reentry device enters the second aperture of the first intravascular device.

16. The method of claim 1, further including:

providing a second intravascular device having a distal portion;

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

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

17. The method of claim 16, 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.

18. The method of claim 17, wherein positioning the distal portion of the first intravascular device in the vascular wall comprises advancing the first intravascular device over the guidewire.

19. The method of claim 18, further comprising withdrawing the guidewire from a guidewire lumen of the first intravascular device.

20. The method of claim 19, further comprising advancing at least a portion of the reentry device into the guidewire lumen of the first intravascular device.

21. The method of claim 20, 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.

22. The method of claim 21, further comprising advancing a therapy catheter over the reentry device.

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

providing a first intravascular device having a distal portion and at least one aperture;

inserting the first intravascular device into the vascular lumen;

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

providing a second intravascular device having a body, a core, and a distal tip, the core being movable relative to the body;

inserting the distal tip of the second intravascular device in the distal portion of the first intravascular device; and

advancing the distal tip of the second intravascular device through at least one aperture of the first intravascular device.

24. The method of claim 23, further including positioning the at least one aperture of the first intravascular device beyond the occlusion.

25. The method of claim 23, further including positioning the distal tip of the second intravascular device in the aperture of the first intravascular device.

26. The method of claim 25, wherein positioning the distal tip of the second intravascular device includes rotating the second intravascular device.

27. The method of claim 23, wherein the at least one aperture includes two apertures, and wherein the first aperture is located proximal the second aperture.

28. The method of claim 27, further including positioning the distal tip of the second intravascular device in the second aperture of the first intravascular device.

29. The method of claim 27, further comprising orienting the at least one aperture of the first intravascular device towards the vascular lumen and orienting the second aperture towards an adventitia of the vascular wall.

30. The method of claim 27, wherein the at least one aperture includes two apertures, and wherein the first aperture is located proximal the second aperture.

31. The method of claim 30, further including:

advancing a distal tip of a second intravascular device through one of the first aperture and the second aperture; and

determining whether the distal tip of the second intravascular device is directed toward the vascular lumen or directed toward the adventitia of the vascular wall.

32. The method of claim 31, wherein determining whether the distal tip of the second intravascular device is directed toward the vascular lumen or directed toward the adventitia comprises viewing the distal tip of the second intravascular device using fluoroscopy.

33. The method of claim 31, further comprising advancing the distal tip of the second intravascular device through an intimal portion of the vascular wall if it is determined that the distal tip of the second intravascular device is directed toward the vascular lumen.

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

35. The method of claim 31, further comprising withdrawing the distal tip of the second intravascular device into the lumen of the first intravascular device if it is determined that the distal tip of the second intravascular device is directed toward the adventitia of the vascular wall.

36. The method of claim 35, further comprising advancing the distal tip of the second intravascular device through the other of the first aperture and the second aperture.

37. The method of claim 36, further comprising determining whether the distal tip of the second intravascular device is directed toward the vascular lumen or directed toward the adventitia of the vascular wall.

38. The method of claim 27, wherein the first intravascular device includes at least one radiopaque marker located distal the first aperture.

39. The method of claim 38, wherein the at least one radiopaque marker comprises a first radiopaque marker located between the first aperture and the second aperture, and a second radiopaque marker located distal the second aperture.

40. The method of claim 39, further including providing a flouroscopic display and positioning the distal tip of the second intravascular device proximal the first radiopaque marker of the first intravascular device.

41. The method of claim 40, further including rotating the second intravascular device until the distal tip of the second intravascular device enters the first aperture of the first intravascular device.

42. The method of claim 39, further including providing a flouroscopic display and positioning the distal tip of the second intravascular device proximal the second radiopaque marker of the first intravascular device and distal the first radiopaque marker of the first intravascular device.

43. The method of claim 42, further including rotating the second intravascular device until the distal tip of the second intravascular device enters the second aperture of the first intravascular device.

44. The method of claim 23, further including advancing the distal tip of second intravascular device into the vascular lumen.

45. The method of claim 23, wherein the body of the second intravascular device defines a device lumen, the core of the second intravascular device includes a distal tip, and wherein the core is located in the device lumen.

46. The method of claim 45, further including moving the distal tip of the core beyond the distal tip of the second intravascular device.

47. The method of claim 46, further including advancing the distal tip of the second intravascular device into the vascular lumen by piercing an intimal layer of the vascular wall with the core of the second intravascular device.

48. The method of claim 47, wherein the distal tip of the core includes a penetrator, and wherein the penetrator is configured to pierce the vascular wall.

49. The method of claim 45, wherein when the distal tip of the core is within the device lumen, the distal tip of the second intravascular device is blunt.

50. The method of claim 49, wherein when the distal tip of the core is advanced beyond the device lumen, the distal tip of the second intravascular device is sharp.

51. The method of claim 23, further including removing the first intravascular device from the vascular wall while leaving the second intravascular device in the vascular wall.

52. The method of claim 23, further including:

providing a third intravascular device having a distal portion;

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

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

53. The method of claim 52, further including advancing a guidewire through a lumen of the third intravascular device, and removing the third intravascular device from the vascular wall while leaving the guidewire in the vascular wall.

54. The method of claim 23, wherein the first intravascular device further includes at least one orienting element for orienting the at least one aperture of the first intravascular device towards the vascular wall.

55. The method of claim 54, wherein the at least one orienting element comprises a balloon, and orienting the at least one aperture of the first intravascular device towards the vascular wall includes inflating the balloon.

56. The method of claim 55, wherein the at least one orienting element comprises two balloons, and orienting the at least one aperture of the first intravascular device towards the vascular wall includes inflating the two balloons.

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

providing an orienting device having a distal portion and at least one aperture;

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

orienting the first intravascular device so that the at least one aperture faces an intimal layer of the vascular wall;

providing a reentry device having a body and a penetrator extending distally beyond a distal end of the body; and

advancing the penetrator and the distal end of the body through the at least one aperture of the first intravascular device.

58. The method of claim 57, further comprising contacting the intimal layer of the vascular wall with the penetrator.

59. The method of claim 58, further comprising contacting the intimal layer of the vascular wall with the distal end of the body.

60. The method of claim 59, wherein the penetrator contacts the intimal layer of the vascular wall before the distal end of the body contacts the intimal layer of the vascular wall.

61. The method of claim 57, further comprising piercing the intimal layer of the vascular wall with the penetrator.

62. The method of claim 61, further comprising piercing the intimal layer of the vascular wall with the distal end of the body.

63. The method of claim 62, wherein the penetrator pierces the intimal layer of the vascular wall before the distal end of the body pierces the intimal layer of the vascular wall.

64. The method of claim 57, wherein providing the reentry device comprises providing a reentry device having 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.

65. The method of claim 64, wherein moving the core relative to the body comprises moving a distal end of the core beyond the distal end of the body.

66. The method of claim 57, wherein providing the reentry device comprises providing a reentry device in which the penetrator is fixed relative to the body.

67. The method of claim 57, further comprising advancing the distal end of the body of the reentry device into the vascular lumen.

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

providing a first intravascular device having a distal portion and at least one aperture;

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

orienting the first intravascular device so that the at least one aperture faces an intimal portion of the vascular wall;

providing a reentry device having a first configuration in which a distal tip of the reentry device is sharp and a second configuration in which the distal tip of the reentry device is blunt;

advancing the distal tip of the reentry device through the at least one aperture of the first intravascular device; and

advancing the distal tip of the reentry device through the intimal portion of the vascular wall.

69. The method of claim 68, wherein the distal tip of the reentry device is advanced through the intimal portion of the vascular wall while the reentry device is in the first configuration.

70. The method of claim 69, further comprising causing the reentry device to assume the second configuration after the distal tip has advanced through the intimal portion of the vascular wall.

71. The method of claim 69, further comprising advancing the distal tip of the reentry device into the vascular lumen.

72. The method of claim 71, further comprising causing the reentry device to assume the second configuration while the distal tip of the reentry device is disposed in the vascular lumen.

73. The method of claim 68, wherein:

the reentry device comprises a body defining a device lumen and a core disposed in the device lumen; and

the method comprises moving the core in a distal direction relative to the body to cause the reentry device to assume the first configuration.

74. The method of claim 68, wherein:

the reentry device comprises a body defining a device lumen and a core disposed in the device lumen; and

the method comprises moving the core in a proximal direction relative to the body to cause the reentry device to assume the second configuration.

75. The method of claim 68, wherein:

the reentry device comprises a body defining a device lumen and a core disposed in the device lumen; and

a distal portion of the core extends distally beyond the device lumen when the reentry device is in the first configuration.

76. The method of claim 68, wherein:

the reentry device comprises a body defining a device lumen and a core disposed in the device lumen; and

a distal portion of the core is disposed within the device lumen when the reentry device is in the second configuration.

77-133. -133. (canceled)