Emboli protection devices and related methods of use

• US 20020165574A1
• Filed: 08/29/2001
• Published: 11/07/2002
• Est. Priority Date: 05/01/2001
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: Velocimed LLC (Abbott Laboratories)
• Inventors: Ressemann, Thomas V., Keith, Peter T., Wahr, Dennis W., Hackett, Steven S., Olson, Scott A., Dusbabek, Andrew J.
• Granted Patent: US 7,374,560 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• 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 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts

Abstract

An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The evacuation sheath assembly includes an elongated tube defining an evacuation lumen having proximal and distal ends. A proximal sealing surface is provided on a proximal portion of the tube and is configured to form a seal with a lumen of a guided catheter. A distal sealing surface is provided on a distal portion of the tube and is configured to form a seal with a blood vessel. Obturator assemblies and infusion catheter assemblies are provided to be used with the evacuation sheath assembly. A method of treatment of a blood vessel using the evacuation sheath assembly includes advancing the evacuation sheath assembly into the blood vessel through a guide catheter. Normal antegrade blood flow in the blood vessel proximate to the stenosis is stopped and the stenosis is treated. Retrograde blood flow is induced within the blood vessel to carry embolic material dislodged during treating into the evacuation sheath assembly. If necessary to increase retrograde flow, the coronary sinus may be at least partially occluded. Alternatively, antegrade flow may be permitted while flow is occluded at the treatment site.

Claims

1. A method of treatment of a blood vessel, comprising:

advancing an evacuation sheath assembly into the blood vessel;

stopping normal antegrade blood flow in the blood vessel proximate to the stenosis;

advancing a therapeutic catheter into the blood vessel;

treating the stenosis with the therapeutic catheter;

advancing an infusion catheter to a location distal to the stenosis;

infusing the blood vessel with a fluid supplied by the infusion catheter; and

inducing retrograde flow within the blood vessel to carry embolic material dislodged during treating into the evacuation sheath assembly.

2. The method of claim 1, wherein advancing the infusion catheter includes advancing the infusion catheter through a distal end of the evacuation sheath assembly.

3. The method of claim 1, wherein stopping blood flow includes creating a first seal between a distal portion of the evacuation sheath assembly and the blood vessel.

4. The method of claim 3, wherein stopping blood flow further comprises creating a second seal between a guide catheter and a proximal portion of the evacuation sheath assembly.

5. The method of claim 1, wherein inducing retrograde flow includes applying a vacuum through the evacuation sheath assembly.

6. The method of claim 1, wherein treating the stenosis includes advancing an angioplasty catheter to the stenosis.

7. The method of claim 1, wherein treating the stenosis includes advancing a stent delivery system to the stenosis.

8. The method of claim 1, wherein inducing retrograde flow includes venting pressure in a collection device in fluid communication with the blood vessel with normal antegrade blood flow stopped.

9. The method of claim 8, wherein inducing retrograde flow further includes applying suction to the collection device.

10. The method of claim 1, wherein the blood vessel is a coronary artery.

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

12. The method of claim 1, wherein the step of stopping normal antegrade flow is performed prior to advancing a device across the stenosis.

13. The method of claim 1, wherein infusing the blood vessel with a fluid includes delivering a fluid through at least one infusion port of the infusion catheter.

14. The method of claim 1, wherein infusing the blood vessel with a fluid includes delivering the fluid to a location distal to the treated stenosis.

15. The method of claim 1, wherein infusing the blood vessel with a fluid includes infusing saline into the blood vessel.

16. The method of claim 1, wherein infusing the blood vessel with a fluid includes infusing whole blood into the blood vessel.

17. The method of claim 1, wherein infusing the blood vessel with a fluid includes infusing radiopaque dye into the blood vessel.

18. The method of claim 1, wherein advancing the evacuation sheath assembly includes advancing the evacuation sheath assembly through a guide catheter, and further comprising applying a vacuum to the guide catheter prior to infusing the fluid.

19. The method of claim 1, further comprising inducing retrograde flow prior to advancing the infusion catheter to move debris proximal to the treated stenosis.

20. A method for treating a blood vessel, comprising:

positioning a guide catheter proximate to the blood vessel;

positioning an evacuation sheath assembly within the blood vessel;

stopping normal antegrade blood flow in the blood vessel proximate to the site;

advancing an interventional catheter into the blood vessel to treat the site of the blood vessel;

occluding blood flow at the site with the interventional catheter;

permitting antegrade blood flow around the guide catheter and evacuation sheath assembly toward the treatment site while blood flow is occluded by the interventional catheter; and

applying a vacuum to the evacuation sheath assembly to carry embolic debris and antegrade blood flow into the evacuation sheath while blood flow is occluded by the interventional catheter.

21. The method of claim 20, wherein stopping normal antegrade blood flow is performed prior to advancing a device across the treatment site.

22. The method of claim 20, further including applying a vacuum to the evacuation sheath assembly prior to occluding blood flow.

23. The method of claim 22, wherein the blood vessel is a coronary artery.

24. The method of claim 22, wherein the blood vessel is a saphenous vein graft.

25. The method of claim 22, further comprising treating the site in the blood vessel, the treating including inflating a balloon.

26. The method of claim 25, further comprising deflating the balloon after treating the area of the blood vessel.

27. The method of claim 26, wherein occluding blood flow includes re-inflating the balloon of the interventional catheter.

28. The method of claim 22, wherein stopping normal antegrade blood flow includes creating a first seal between a distal portion of the evacuation sheath assembly and the blood vessel and includes creating a second seal between a proximal portion of the evacuation sheath assembly and the guide catheter.

29. The method of claim 28, wherein permitting antegrade blood flow includes releasing the first seal.

30. The method of claim 22, wherein advancing the interventional catheter includes advancing the interregional catheter through the evacuation sheath assembly.

31. An evacuation sheath assembly, comprising:

an elongate hollow member having proximal and distal ends, first and second lumens, and first and second sealing members, wherein the proximal end is flared, and wherein the first lumen is an evacuation lumen configured to be placed in fluid communication with a bloodstream and wherein the second lumen is an inflation lumen in fluid communication with at least one of the first and second sealing members; and

a shaft in fluid communication with the inflation lumen and configured to connect to an inflation source.

32. The assembly of claim 31, wherein the first and second sealing members are balloons.

33. The assembly of claim 31, wherein the first and second sealing members are elastomeric.

34. The assembly of claim 31, wherein the first sealing member is located on a proximal portion of the elongated hollow member and the second sealing member is located on a distal portion of the elongated hollow member.

36. The assembly of claim 35, wherein a distal end of the elongated hollow member is perpendicular to a longitudinal axis of the elongated hollow member.

37. The assembly of claim 36, wherein one of said first and second sealing members is adjacent the distal end of the elongated hollow member.

39. The combination of claim 38, wherein the distal tip is a flexible, steerable tip.

35. An evacuation sheath assembly, comprising:

an elongate hollow member supported by a kink-resisting coil and having first and second lumens, and first and second sealing members, wherein the first lumen is an evacuation lumen configured to be placed in fluid communication with a bloodstream and wherein the second lumen is an inflation lumen in fluid communication with at least one of the first and second sealing members; and

a shaft in fluid communication with the inflation lumen and configured to connect to an inflation source.

38. A combination for isolating fluid communication between a blood vessel and a catheter, comprising:

a catheter having a lumen;

an obturator having a proximal end and a distal end, wherein the distal end includes a distal tip having a first tapering diameter; and

an evacuation sheath assembly configured to move within the lumen of the catheter and having an evacuation lumen and first and second sealing members, wherein the evacuation sheath assembly has a second diameter greater than the first tapering diameter.

40. A combination for isolating fluid communication between a blood vessel and a catheter, comprising:

a catheter having a lumen; and

an evacuation sheath assembly configured to move within the lumen of the catheter and having an evacuation lumen and first and second sealing members, wherein a proximal end of the evacuation lumen is flared.

41. The combination of claim 40, wherein the flared end of the evacuation lumen is configured to isolate fluid communication between the blood vessel and the catheter lumen.

42. The combination of claim 40, wherein the flared end of the evacuation sheath assembly is configured to seal against the lumen of the catheter.

43. The combination of claim 40, wherein the first sealing member includes a proximal portion of the evacuation sheath assembly configured to seal against the lumen of the catheter.

44. The combination of claim 40, wherein the second sealing member is located on a distal portion of the evacuation sheath assembly.

45. The combination of claim 40, wherein the first and second sealing members include expandable surfaces.

46. The combination of claim 40, wherein the second sealing member is configured to create a seal between the evacuation sheath assembly and the blood vessel.

47. The combination of claim 40, wherein a distal end of the evacuation lumen is perpendicular to a longitudinal axis of the evacuation lumen.

48. The combination of claim 47, wherein the second sealing member is adjacent the distal end of the evacuation lumen.

50. The combination of claim 49, wherein the balloon is configured to form a seal with the evacuation lumen.

51. The combination of claim 49, wherein the balloon is configured to expand a treatment site prior to treatment.

49. A combination for isolating fluid communication between a blood vessel and a catheter, comprising:

a catheter having a lumen;

an obturator having a proximal end and a distal end, wherein the distal end includes a balloon and distal tip having a first tapering diameter; and

an evacuation sheath assembly configured to move within the lumen of the catheter and having an evacuation lumen and first and second sealing members, wherein the evacuation sheath assembly has a second diameter greater than the first tapering diameter.

52. A method of treatment of a blood vessel, comprising:

advancing a guide catheter proximate to the blood vessel;

advancing an evacuation sheath assembly through the guide catheter and into the blood vessel while retaining a proximal portion of the evacuation sheath assembly within the guide catheter;

at least partially occluding the coronary sinus;

creating a seal between a distal portion of the evacuation sheath assembly and the blood vessel;

stopping normal antegrade blood flow within the blood vessel;

treating a stenosis within the blood vessel;

causing retrograde flow within the blood vessel to thereby remove embolic material dislodged during the treating and carried by the retrograde flow into the evacuation sheath assembly; and

re-establishing normal antegrade blood flow within the blood vessel.

53. The method of claim 52, further comprising creating a second seal between the proximal portion of the evacuation sheath assembly and the guide catheter.

54. The method of claim 52, wherein at least partially occluding the coronary sinus includes advancing an occlusion catheter into the coronary sinus.

55. The method of claim 52, wherein at least partially occluding the coronary sinus includes expanding a balloon of an occlusion catheter within the coronary sinus.

60. The method of claim 59, wherein stopping normal antegrade blood flow is performed prior to advancing a device across the stenosis.

61. The method of claim 59, wherein maintaining elevated pressure in the coronary sinus includes preventing closure of venous valves.

62. The method of claim 59, wherein maintaining elevated pressure in the coronary sinus includes advancing an occlusion catheter into the coronary sinus.

63. The method of claim 62, wherein maintaining elevated pressure in the coronary sinus further includes inflating an occlusion balloon in the coronary sinus.

64. The method of claim 59, wherein maintaining elevated pressure in the coronary sinus includes occluding the coronary sinus prior to stopping normal antegrade blood flow.

65. The method of claim 59, wherein treating the stenosis includes inflating a stent balloon, and wherein maintaining elevated pressure in the coronary sinus includes occluding the coronary sinus prior to deflating the stent balloon.

56. An evacuation sheath assembly, comprising:

an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and

at least one inflatable sealing surface in fluid communication with the inflation lumen;

wherein the open distal end of the evacuation lumen is perpendicular to a longitudinal axis of the evacuation lumen.

57. A combination for isolating fluid communication between a blood vessel and a catheter, comprising:

a guide catheter having a lumen;

an evacuation sheath assembly configured to move within the lumen of the guide catheter and having an evacuation lumen and first and second sealing surfaces; and

an infusion catheter assembly having an infusion lumen and at least one infusion port, the infusion catheter assembly being configured to move within the evacuation lumen.

58. An infusion catheter assembly comprising:

a proximal shaft portion having a proximal infusion lumen; and

a distal shaft portion connected to a distal end of the proximal shaft portion, the distal shaft portion including a distal infusion lumen in flow communication with the proximal infusion lumen, at least one infusion port, and a guidewire lumen, wherein the guidewire lumen is shorter than the combined length of the proximal and distal infusion lumens.

59. A method of treatment of a blood vessel, comprising:

advancing an evacuation sheath assembly into the blood vessel;

maintaining elevated pressure in the coronary sinus;

stopping normal antegrade blood flow in the blood vessel proximate to the stenosis;

treating the stenosis; and

inducing retrograde blood flow within the blood vessel to carry embolic material dislodged during treating into the evacuation sheath assembly.

66. A combination for isolating fluid communication between a blood vessel and a catheter, comprising:

a guide catheter having a lumen;

an evacuation sheath assembly configured to move within the lumen of the guide catheter and having an evacuation lumen and first and second sealing surfaces; and

an infusion catheter assembly configured to move within the evacuation lumen.

68. The method of claim 67, wherein treating the stenosis includes expanding a balloon of the interventional device.

69. The method of claim 68, wherein expanding the balloon includes forming a seal between the blood vessel and the balloon.

70. The method of claim 69, wherein inducing retrograde flow deflating the balloon.

67. A method of treating a blood vessel, comprising:

advancing an evacuation sheath assembly into the blood vessel;

creating a first seal between the blood vessel and the evacuation sheath assembly;

advancing an interventional device across a stenosis to be treated;

treating the stenosis;

inducing retrograde flow at the stenosis;

establishing a second seal between the blood vessel and the interventional device;

releasing the first seal to permit antegrade blood flow toward the treatment site; and

applying suction to carry embolic material dislodged during treating and the antegrade blood flow into the evacuation sheath assembly.