Methods for reducing distal embolization

• US 6,652,480 B1
• Filed: 11/10/1999
• Issued: 11/25/2003
• Est. Priority Date: 03/06/1997
• Status: Expired due to Fees

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Imran, Mir A., Muni, Ketan P., Zadno-Azizi, Gholam-Reza
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US09/438,030
• Time in Patent Office: 1,476 Days
• Field of Search: 604/28, 604/35, 604/500, 604/506, 604/507, 604/508, 604/509, 604/510, 604/96.01, 604/104, 604/532, 604/907, 604/912, 606/159, 606/194
• US Class Current: 604/35
• 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 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A method for reducing distal embolization during insertion of devices to treat plaque, thrombi and other intravascular occlusions. Using a guide catheter, a guidewire is delivered to a site proximal to the lesion. An aspiration catheter is then introduced over the guidewire, and the two are moved together in a distal to proximal direction across the occlusion. The aspiration catheter is then moved in a proximal to distal direction while continuously aspirating, which prevents embolization of any particles which may be created during the crossing of the guidewire.

Claims

1. A method for the evacuation of an occlusive substance from the wall of a blood vessel, comprising:

positioning a distal end of a guidewire proximal to at least a portion of the occlusive substance on the wall of said blood vessel;

introducing an aspiration catheter over said guidewire;

aspirating through the aspiration catheter while crossing the site of the occlusive substance with both the distal end of the guidewire and a distal end of the aspiration catheter;

removing the aspiration catheter from the blood vessel; and

advancing a therapy catheter into the blood vessel to treat the occlusive substance after removing the aspiration catheter.

2. The method of claim 1, further comprising moving the distal end of the aspiration catheter in a distal to proximal direction following delivery of the guidewire across the site of the occlusive substance.

3. The method of claim 2, further comprising aspirating while moving the distal end of the aspiration catheter in a distal to proximal direction.

4. The method of claim 3, further comprising repeating said crossing while aspirating in both a proximal to distal and in a distal to proximal direction.

5. The method of claim 1, wherein said occlusive substance includes an embolus.

6. The method of claim 1, wherein said guidewire includes an occlusive device at its distal end.

7. The method of claim 6, wherein said occlusive device is a balloon.

8. The method of claim 6, further comprising activating said occlusive device to prevent particle migration past said occlusive device.

9. The method of claim 8, further comprising delivering a therapy catheter to perform therapy on said occlusive substance following activation of said occlusive device.

10. The method of claim 9, wherein said therapy catheter is selected from the group consisting of an angioplasty balloon catheter, a stent delivery catheter and an atherectomy catheter.

11. The method of claim 1, wherein said blood vessel is a saphenous vein graft.

29. The method of claim 1, further comprising exchanging the guidewire for a guidewire having an occlusive device at its distal end.

30. The method of claim 29, wherein said exchange occurs prior to removal of the aspiration catheter.

31. The method of claim 30, wherein said exchange occurs after removal of the aspiration catheter.

12. A method for treatment of an occlusion in a totally occluded blood vessel or partially occluded blood vessel defined by thrombolysis in myocardial infarction (TIMI) flow of 0-1, comprising:

delivering a guidewire until its distal end is proximal to the occlusion;

delivering an aspiration catheter until a distal end of the aspiration catheter is proximal the occlusion;

simultaneously crossing the site of the occlusion in a proximal to distal direction with said distal end of the guidewire and the distal end of the aspiration catheter while aspirating;

moving the distal end of the aspiration catheter back across the site of the occlusion in a distal to proximal direction while aspirating;

exchanging said guidewire for a guidewire having an occlusive device at its distal end; and

positioning the occlusive device at a site distal to the occlusion, and activating said occlusive device.

13. The method of claim 12, further comprising inserting a therapy catheter to perform therapy on said occlusion.

14. The method of claim 13, further comprising introducing said aspiration catheter to remove debris generated during said therapy.

15. The method of claim 12, wherein said blood vessel is a saphenous vein graft.

16. The method of claim 12, wherein said occlusion includes an embolus.

17. The method of claim 12, wherein said occlusive device is a balloon.

18. The method of claim 12, further comprising repeating at least once said crossing while aspirating and moving said aspiration catheter in a distal to proximal direction.

19. A method for treatment of an occlusion in a partially occluded blood vessel, comprising:

delivering a guidewire having an occlusive device at its distal end until the distal end is distal said occlusion;

delivering an aspiration catheter until its distal end is proximal to the occlusion;

activating said occlusive device; and

crossing the site of the occlusion with the distal end of the aspiration catheter while aspirating.

20. The method of claim 19, further comprising moving the distal end of the aspiration catheter in a distal to proximal direction across the occlusion while aspirating.

21. The method of claim 19, further comprising inserting a therapy catheter to perform therapy on said occlusion following activation of the occlusive device.

22. The method of claim 21, further comprising removing the aspiration catheter prior to inserting the therapy catheter.

23. The method of claim 19, further comprising introducing said aspiration catheter after performing therapy to remove debris generated during said therapy.

24. The method of claim 19, wherein said blood vessel is a saphenous vein graft.

25. The method of claim 19, wherein said occlusion includes an embolus.

26. The method of claim 19, wherein said occlusive device is a balloon.

27. The method of claim 20, further comprising repeating at least once said crossing while aspirating and moving said aspiration catheter in a distal to proximal direction.

28. The method of claim 21, wherein said therapy catheter is selected from the group consisting of an atherectomy catheter, stent and balloon catheter.

48. The method of claim 19, wherein said aspiration catheter is delivered before activating said occlusive device.

32. A method for treating an occlusive substance from the wall of a blood vessel, comprising:

positioning a distal end of a guidewire having an occlusive device at its distal end proximal to at least a portion of the occlusive substance on the wall of said blood vessel;

introducing an aspiration catheter over said guidewire;

prior to treating the occlusive substance, aspirating through the aspiration catheter while crossing the site of the occlusive substance with both the distal end of the guidewire and a distal end of the aspiration catheter; and

treating the occlusive substance.

33. The method of claim 32, wherein said occlusive device is a balloon.

34. The method of claim 32, further comprising activating said occlusive device to prevent particle migration past said occlusive device prior to said treatment.

35. The method of claim 34, further comprising delivering a therapy catheter to perform therapy on said occlusive substance following activation of said occlusive device.

36. The method of claim 35, wherein said therapy catheter is selected from the group consisting of an angioplasty balloon catheter, a stent delivery catheter and an atherectomy catheter.

37. The method of claim 35, further comprising removing the aspiration catheter from the blood vessel prior to delivering the therapy catheter.

38. A method for treatment of an occlusion in a blood vessel, comprising:

delivering a guidewire having a distal end until the distal end is distal of said occlusion;

delivering an aspiration catheter until its distal end is proximal to the occlusion;

crossing the site of the occlusion with the distal end of the aspiration catheter while aspirating, wherein the site of the occlusion is crossed with the distal end of the aspiration catheter in a proximal to distal direction while aspirating;

crossing the site of the occlusion with the distal end of the aspiration catheter in a distal to proximal direction while aspirating; and

repeating said crossing while aspirating in both a proximal to distal and in a distal to proximal direction.

39. A method for treatment of an occlusion in a blood vessel, comprising:

delivering a guidewire having a distal end until the distal end is distal of said occlusion;

delivering an aspiration catheter until its distal end is proximal to the occlusion;

crossing the site of the occlusion with the distal end of the aspiration catheter while aspirating; and

exchanging the guidewire for a guidewire having an occlusive device on its distal end.

40. The method of claim 39, wherein said exchange occurs through said aspiration catheter.

41. A method for treatment of an occlusion in a blood vessel, comprising:

delivering a guidewire having a distal end until the distal end is distal of said occlusion;

delivering an aspiration catheter until its distal end is proximal to the occlusion;

activating an occlusive device within said vessel to at least partially occlude blood flow; and

crossing the site of the occlusion with the distal end of the aspiration catheter while aspirating and while said occlusive device is activated.

42. The method of claim 41, wherein the site of the occlusion is crossed with the distal end of the aspiration catheter in a proximal to distal direction while aspirating.

43. The method of claim 42, further comprising crossing the site of the occlusion with the distal end of the aspiration catheter in a distal to proximal direction while aspirating.

44. The method of claim 43, further comprising repeating said crossing while aspirating in both a proximal to distal and in a distal to proximal direction.

45. The method of claim 41, further comprising exchanging the guidewire for a guidewire having an occlusive device on its distal end.

46. The method of claim 45, wherein said exchange occurs through said aspiration catheter.

47. The method of claim 41, wherein the guidewire includes said occlusive device on its distal end, and said occlusive device is activated distal to said occlusion.

49. The method of claim 41, wherein the guidewire is delivered until its distal end is distal of said occlusion prior to delivering the aspiration catheter until its distal end is proximal to the occlusion.