Aspiration method

• US 6,454,741 B1
• Filed: 03/24/2000
• Issued: 09/24/2002
• Est. Priority Date: 03/06/1997
• Status: Expired due to Term

• Current Assignee: Kardiametrics LLC (IPNav)
• Original Assignee: Medtronic PercuSurge, Inc. (Medtronic Plc)
• Inventors: Bagaoisan, Celso, Muni, Ketan P., Zadno-Azizi, Gholam Reza
• Primary Examiner(s): Hayes, Michael J.
• Assistant Examiner(s): Lewis, Michelle
• Application Number:
  US09/537,471
• Time in Patent Office: 914 Days
• Field of Search: 604/915-921, 604/507-509, 604/96.01, 604/109, 604/164.13, 606/192-200, 600/585, 600/434
• US Class Current: 604/96.01
• 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: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• 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 the treatment of a stenosis or an occlusion in a blood vessel in which an occlusive device is first delivered and activated at a site distal to the occlusion to at least partially occlude the vessel. A therapy catheter is then introduced to treat the occlusion and a debris removal device is delivered to aspirate debris from the vessel. The present invention eliminates the need for a separate irrigation catheter and irrigation fluid which allows the procedure to be performed quickly and efficiently, and is especially useful in the removal of occlusion from saphenous vein graft, the coronary and carotid arteries, arteries above the aortic arch and vessels of similar size and pressure.

Claims

1. A method of treatment of a blood vessel in which blood fluid flows proximally to distally, said method comprising:

delivering a guidewire having a proximal end and a distal end and an expandable device thereon into the blood vessel, said expandable device being actuatable between a nonexpanded state and an expanded state, said expandable device when in said expanded state forming a barrier sufficient to inhibit emboli suspended in said fluid from migrating past the barrier in a proximal to distal direction;

preventing emboli from moving in a distal to proximal direction by exposing said expandable device to blood fluid pressure within said vessel;

advancing a catheter having a lumen in fluid communication with a distal opening in the catheter, said advancing comprising moving said distal opening relative to said expandable device within the blood vessel such that said opening is distal to at least a portion of an occlusive substance within said blood vessel, said occlusive substance comprising said emboli suspended in said fluid; and

drawing fluid from the vessel into the distal opening such that (a) a fluid flow is created in the lumen in a distal to proximal direction, and (b) said fluid flow is simultaneously created in said vessel in a proximal to distal direction, whereby said emboli are carried by said fluid flow from said vessel into said distal opening and through said lumen of said catheter.

2. The method of claim 1, wherein the occlusive substance includes material on a wall of the vessel.

3. The method of claim 2, wherein said advancing comprises moving said distal opening such that said distal opening is distal to at least some of the material on the wall of the vessel.

4. The method of claim 1, further comprising moving the distal opening in the catheter relative to the expandable device during said drawing of fluid.

5. The method of claim 1, wherein said expandable device is an inflatable balloon.

6. The method of claim 1, wherein said expandable device is a filter.

7. The method of claim 1, further comprising advancing a guide catheter until a distal end of the guide catheter is positioned proximal to the emboli, and wherein said catheter is advanced through said guide catheter.

8. The method of claim 1, wherein said blood vessel comprises a saphenous vein graft.

9. The method of claim 8, wherein said fluid pressure is provided by blood from the aorta.

10. The method of claim 1, wherein said blood vessel comprises a carotid artery.

11. The method of claim 1, wherein the emboli are located in a segment of the blood vessel having substantially no side branches.

12. The method of claim 1, wherein the catheter is advanced over the guidewire.

13. A method for the evacuation of emboli from a blood vessel comprising:

positioning an expandable device distal to a location in the vessel having an occlusion on the walls of said vessel;

positioning a catheter having a lumen in fluid communication with a distal opening in the catheter such that said opening is distal to said location;

drawing fluid from the vessel into the distal opening such that emboli broken off from said occlusion are carried by said fluid from said vessel into said distal opening and through said lumen of said catheter; and

moving the distal opening in the catheter until it is proximal to said location during the drawing of fluid into the distal opening.

14. The method of claim 13, wherein positioning said expandable device further comprises delivering a guidewire into said vessel, said guidewire carrying said expandable device.

15. The method of claim 14, wherein said catheter is positioned in the blood vessel over said guidewire.

16. The method of claim 13, further comprising actuating said expandable device into an expanded position prior to drawing fluid from the vessel.

17. The method of claim 13, wherein said drawing fluid further comprises creating a fluid flow in the lumen in a distal to proximal direction, and simultaneously creating fluid flow in the vessel in a proximal to distal direction.

18. The method of claim 13, wherein the distal opening in the catheter is positioned distal said location more than once during the drawing of fluid.

19. The method of claim 13, wherein said expandable device is an inflatable balloon.

20. The method of claim 13, wherein said expandable device is a filter.

21. The method of claim 13, further comprising, prior to drawing fluid into the distal opening of the catheter, performing therapy on the occlusion, the performing of therapy causing emboli to break off from the occlusion.

22. A method for the treatment of an occlusion in a blood vessel having a fluid pressure of at least 0.2 psi, comprising:

inserting a guidewire having an occlusive device at its distal end into said blood vessel, until said occlusive device is distal to said occlusion;

activating said occlusive device to at least partially occlude said vessel distal to said occlusion and create a working area around said occlusion;

advancing a therapy catheter into said blood vessel until it reaches said occlusion;

performing therapy on said occlusion;

utilizing fluid pressure within said vessel to inhibit particles produced during therapy from substantial migration in a direction proximal to said occlusion;

removing said therapy catheter;

delivering an aspiration catheter having a proximal end and a distal end over said guidewire until the distal end of said aspiration catheter is at a location proximal to the occlusive device and distal to the occlusion;

creating a flow of fluid within said vessel in a proximal to distal direction by aspirating fluid from said working area inside the vessel through said distal end of said aspiration catheter, whereby said particles are removed from the working area and said fluid pressure provides fluid to replace fluid aspirated from the working area; and

deactivating said occlusive device and removing said catheter.

23. The method of claim 22, wherein said aspiration catheter comprises a hollow lumen and a separate second lumen for receiving said guidewire, and wherein said aspiration catheter is delivered by inserting a proximal end of said guidewire into said second lumen, and slidably advancing said second lumen of said aspiration catheter over said guidewire.

24. The method of claim 22, wherein said distal end of said aspiration catheter is inserted at least one time to a position no more than about 5 cm proximal to said occlusive device and thereafter slidably withdrawn in a proximal direction.

25. The method of claim 22, wherein said blood vessel is selected from the group consisting of a saphenous vein graft, a coronary artery, and a vessel above the aortic arch.

26. The method of claim 22, wherein said blood vessel has a fluid flow rate of at least about 10 cc per minute.

27. The method of claim 22, wherein said blood vessel has a fluid flow rate of from about 60 to about 80 cc per minute.

28. The method of claim 22, further comprising inserting a guide catheter to aid in the insertion of said occlusive device and said guidewire.

29. The method of claim 22, wherein activating said occlusive device results in the vessel being substantially occluded.

30. The method of claim 22, wherein said occlusive device is a balloon and said activating step comprises inflating said balloon.

31. The method of claim 22, wherein said occlusive device is a filter and said activating step comprises deploying said filter to prevent migration of particles downstream.

32. The method of claim 22, wherein performing said therapy comprises delivering a drug directly to the site of said occlusion.

33. The method of claim 22, wherein performing said therapy comprises creating a venturi effect within said vessel to aspirate said occlusion, and wherein the fluid aspiration occurs simultaneously.

34. The method of claim 22, wherein performing said therapy comprises creating fluid turbulence within said vessel to aspirate said occlusion, and wherein the fluid aspiration occurs simultaneously.

35. The method of claim 22, wherein said therapy catheter is selected from the group consisting of a thrombectomy catheter, a rheolitic device, and a device which creates a venturi effect within the vessel, and wherein the therapy and the fluid aspiration are performed simultaneously.

36. The method of claim 22, further comprising moving the distal end of the aspiration catheter within said working area during aspiration.

37. The method of claim 36, wherein the distal end of the aspiration catheter is moved in a distal to proximal direction during aspiration.

38. The method of claim 36, wherein the distal end of the aspiration catheter is moved in a proximal to distal direction during aspiration.

39. The method of claim 22, wherein the emboli are located in a segment of the blood vessel having substantially no side branches.

40. A method of treatment of a blood vessel in which blood flows proximally to distally at a location having an occlusion on the walls of said vessel that constricts said vessel, said method comprising:

delivering a guidewire having a proximal end and a distal end and an expandable device thereon into the blood vessel, said expandable device being actuatable between a nonexpanded state and an expanded state, said expandable device when in said expanded state forming a barrier sufficient to inhibit emboli in said blood from migrating past the barrier in a proximal to distal direction;

preventing emboli from moving in a distal to proximal direction by exposing said expandable device to blood flowing in a proximal to distal direction;

advancing a catheter having a lumen in fluid communication with a distal opening in the catheter, said advancing comprising moving said distal opening relative to said expandable device within the blood vessel such that said opening is distal to said occlusion within said blood vessel; and

drawing blood from the vessel into the distal opening such that (a) a blood flow is created in the lumen in a distal to proximal direction, and (b) said blood flow is simultaneously created in said vessel in a proximal to distal direction, whereby said emboli are carried by said blood flow from said vessel into said distal opening and through said lumen of said catheter.

41. The method of claim 40, wherein said advancing comprises moving said distal opening such that said opening is distal to at least some of the emboli.

42. The method of claim 40, further comprising moving the distal opening in the catheter in a distal to proximal direction during said drawing of blood to cross at least a portion of the occlusion.

43. The method of claim 40, wherein said expandable device is an inflatable balloon.

44. The method of claim 40, wherein said expandable device is a filter.

45. The method of claim 40, wherein said catheter is advanced over the guidewire.

46. The method of claim 40, further comprising, prior to drawing blood into the distal opening of the catheter, performing therapy on the occlusion, the performing of therapy causing emboli to break off from the occlusion.

47. A method for the evacuation of emboli from a blood vessel in which therapy has been performed on a lesion in the vessel, comprising:

positioning a catheter having a lumen in fluid communication with a distal opening in the catheter such that said opening is in the region of said emboli;

drawing fluid from the vessel into the distal opening such that emboli are carried by said fluid flow from said vessel into said distal opening and through said lumen of said catheter; and

moving the distal opening in the catheter relative to said lesion while continuing to draw fluid into the distal opening.

48. The method of claim 47, wherein the distal opening in the catheter is positioned at a location distal to at least a portion of an occlusive substance within said blood vessel.

49. The method of claim 48, wherein the occlusive substance comprises emboli.

50. The method of claim 48, wherein the occlusive substance includes material that is attached to the walls of the blood vessel.

51. The method of claim 48, wherein the distal opening in the catheter is moved in a distal to proximal direction until it is proximal to said location while drawing fluid into the distal opening.

52. The method of claim 51, further comprising moving the distal opening in the catheter in a proximal to distal direction after moving the distal opening in a distal to proximal direction.

53. The method of claim 47, wherein said catheter is delivered into the blood vessel over a guidewire.

54. The method of claim 53, wherein the guidewire includes an occlusive device at its distal end.

55. The method of claim 54, wherein the occlusive device is an inflatable balloon.

56. The method of claim 54, wherein the occlusive device is a filter.

57. A method for the evacuation of emboli from a blood vessel comprising:

delivering a guidewire carrying an expandable device near its distal end to a location in the vessel having an occlusion on the walls of the vessel;

actuating said expandable device to inhibit emboli in said blood vessel from migrating past said expandable device;

positioning a catheter having a lumen in fluid communication with a distal opening in the catheter over said guidewire such that said opening is proximal to said expandable device;

drawing fluid from the vessel into the distal opening such that emboli are carried by said fluid from said vessel into said distal opening and through said lumen of said catheter, and

moving the distal opening of the catheter during the drawing of fluid into the distal opening in a direction such that the distal opening crosses at least a portion of the occlusion.

58. The method of claim 57, wherein the expandable device is actuated at a location distal to the occlusion.

59. The method of claim 57, wherein the distal opening of the catheter is moved during the drawing of fluid in a direction such that the distal opening crosses at least a portion of the occlusion.

60. The method of claim 57, wherein the emboli are carried through said lumen of said catheter in a distal to proximal direction.

61. The method of claim 57, further comprising, prior to drawing fluid from the vessel into the distal opening, performing therapy on said occlusion, the performing of therapy causing emboli to break off from the occlusion.

62. The method of claim 57, wherein the expandable device is an inflatable balloon.

63. The method of claim 57, wherein the expandable device is a filter.

64. The method of claim 57, wherein the distal opening of the catheter is moved in a distal to proximal direction during the drawing of fluid.

65. The method of claim 57, wherein the distal opening of the catheter is moved in a proximal to distal direction during the drawing of fluid.

66. The method of claim 65, wherein the distal opening of the catheter is moved in a proximal to distal direction after moving the distal opening of the catheter in a distal to proximal direction during the drawing of fluid.

67. The method of claim 57, wherein the distal opening of the catheter is moved over a distance of about 10 cm or more during the drawing of fluid.

68. The method of claim 57, wherein the distal opening of the catheter is moved repeatedly across the occlusion during the drawing of fluid.