Cannula with associated filter and methods of use during cardiac surgery

• US 6,086,605 A
• Filed: 12/17/1997
• Issued: 07/11/2000
• Est. Priority Date: 04/16/1997
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Embolx, Inc.
• Inventors: Maahs, Tracy D., Barbut, Denise
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US08/982,226
• Time in Patent Office: 937 Days
• Field of Search: 606/200, 606/159, 606/181, 128/898, 604/96
• US Class Current: 606/200
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61M 2210/127 Aorta

Abstract

Devices and methods for filtering blood. The devices generally comprise: a mesh for filtering blood flowing within a blood vessel, particularly within an artery such as the aorta; a structure adapted to open and close the mesh within the blood vessel; and a means to actuate the structure. The methods generally include the following steps: introducing a mesh into a blood vessel to entrap embolic material; adjusting the mesh, if necessary, during the course of filtration; and removing the mesh and the entrapped foreign matter from the blood vessel. Additionally, visualization techniques are used to ensure effective filtration.

Claims

1. An aortic cannula with associated filter, comprising:

a cannula having an outer surface, a distal end adapted to enter the aorta, a proximal end adapted to receive blood from a bypass-oxygenator machine, and a lumen which extends longitudinally from the proximal end to the distal end;

an expansion frame attached to the cannula which is expandable between a compressed state and a radially expanded state;

a mesh having a first edge attached circumferentially and continuously to the expansion frame; and

an elastomeric strip attached circumferentially and continuously to the first edge of the mesh, said strip providing a compliant edge adapted to seal against the inner lumen of the aorta during use.

2. The cannula of claim 1, wherein the expansion frame is an inflation seal comprising a tubular balloon which encloses a chamber.

3. The cannula of claim 1, wherein the expansion frame is an umbrella comprising a plurality of arms.

4. The cannula of claim 3, wherein the arms are pivotally connected at a distal end of the arms to the distal end of the cannula, said arms having a proximal region attached to the first edge of the mesh, wherein during use, the proximal region of the arms expands radially outward when the arms are pivoted away from the cannula.

5. The cannula of claim 3, wherein the elastomeric strip is silicone.

6. The cannula of claim 1, wherein the cannula is a substantially cylindrical member which includes, at its proximal end, a fitting which is shaped for attachment to a bypass-oxygenator machine.

7. The cannula of claim 1, wherein the mesh further comprises a second edge which is in contact with the outer surface of the cannula, and wherein the lumen of the cannula extends through the mesh.

8. The cannula of claim 1, wherein the mesh is continuous, and wherein the lumen of the cannula terminates proximal of a distal tip of the mesh.

9. The cannula of claim 1, further comprising a flow diffuser attached to the distal end of the cannula for dispersing blood transmitted through the distal end of the cannula.

10. The arterial cannula of claim 9, wherein the flow diffuser is located inside the cannula lumen.

11. The arterial cannula of claim 9, wherein the flow diffuser is conical.

12. The arterial cannula of claim 9, wherein the flow diffuser is helical.

13. The arterial cannula of claim 9, when the flow diffuser is attached external to the cannula lumen by virtue of a structural support.

14. The arterial cannula of claim 9, wherein the flow diffuser is connected to the filter mesh by a shaft.

15. The cannula of claim 1, further comprising a sleeve which circumferentially encloses the mesh and expansion frame to minimize the profile of the mesh and expansion frame when in the compressed state, wherein said sleeve is operable to roll-up and thereby release the mesh and expansion frame for deployment to the radially expanded state.

16. The arterial cannula of claim 15, further comprising a filter sleeve attached distal to a second edge of the mesh.

17. The arterial cannula of claim 16, wherein the filter sleeve is attached to at least one roll-up control line and one unroll control line.

18. The arterial cannula of claim 17, wherein said control lines enter a control lumen.

19. The arterial cannula of claim 17, further comprising a pulley attached to said unroll and roll-up control lines.

20. The arterial cannula of claim 16, wherein the filter sleeve has a circular cross-section.

21. The arterial cannula of claim 16, wherein the filter sleeve has a thickness between 3 and 14 thousandths of an inch.

22. The cannula of claim 1, wherein a segment of the cannula within the distal end is deformable and radially compresses to circumferentially receive a portion of the expansion frame to minimize the profile of the mesh and expansion frame when in the compressed state, wherein during use, the mesh and expansion frame are deployed to the expanded state, and the deformable segment of the cannula radially expands to transmit a full luminal volume of blood during bypass.

23. An arterial cannula with associated filter, comprising:

a cannula having an outer surface, a distal end adapted to enter an artery, a proximal end adapted to receive blood from a bypass-oxygenator machine, and a lumen which extends longitudinally from the proximal end to the distal end;

an expansion frame attached to the cannula which is expandable between a compressed state and a radially expanded state;

a mesh having a first edge attached circumferentially and continuously to the expansion frame; and

a sleeve which circumferentially encloses the mesh and expansion frame to minimize the profile of the mesh and expansion frame when in the compressed state, wherein said sleeve is operable to roll-up and thereby release the mesh and expansion frame for deployment to the radially expanded state.

24. The cannula of claim 23, wherein the expansion frame is an inflation seal comprising a tubular balloon which encloses a chamber.

25. The cannula of claim 23, wherein the expansion frame is an umbrella comprising a plurality of arms.

26. The cannula of claim 25, wherein the arms are pivotally connected at a distal end to the distal end of the arms of the cannula, said arms having a proximal region attached to the first edge of the mesh, wherein during use, the proximal region of the arms expands radially outward when the arms are pivoted away from the cannula.

27. The cannula of claim 25, further comprising a flexible skirt attached circumferentially and continuously to the first edge of the mesh, said skirt adapted to seal against the inner lumen of the aorta during use.

28. The cannula of claim 23, wherein the cannula is a substantially cylindrical member which includes, at its proximal end, a fitting which is shaped for attachment to a bypass-oxygenator machine.

29. The cannula of claim 23, wherein the mesh further comprises a second edge which is in contact with the outer surface of the cannula, and wherein the lumen of the cannula extends through the mesh.

30. The cannula of claim 23, wherein the mesh is continuous, and wherein the lumen of the cannula terminates proximal of a distal tip of the mesh.

31. The arterial cannula of claim 23, wherein the filter sleeve is attached to the cannula distal to a second edge of the mesh.

32. The arterial cannula of claim 31, wherein the filter sleeve has a thickness between 3 and 14 thousandths of an inch.

33. The arterial cannula of claim 31, wherein the filter sleeve has a circular cross-section.

34. The arterial cannula of claim 31, wherein the filter sleeve is attached to at least one roll-up control line and one unroll control line.

35. The arterial cannula of claim 34, further comprising a pulley attached to said unroll and roll-up control lines.

36. The arterial cannula of claim 34, wherein said control lines enter a control lumen.

38. The cannula of claim 23, further comprising a flow diffuser attached to the distal end of the cannula for dispersing blood transmitted through the distal end of the cannula.

39. The arterial cannula of claim 38, wherein the flow diffuser is located inside the cannula lumen.

40. The arterial cannula of claim 38, wherein the flow diffuser is conical.

41. The arterial cannula of claim 38, wherein the flow diffuser is helical.

42. The arterial cannula of claim 38, when the flow diffuser is attached external to the cannula lumen by virtue of a structural support.

43. The arterial cannula of claim 38, wherein the flow diffuser is connected to the filter mesh by a shaft.

44. The cannula of claim 23, wherein a segment of the cannula within the distal end is deformable and radially compresses to circumferentially receive a portion of the expansion frame to minimize the profile of the mesh and expansion frame when in the compressed state, wherein during use, the mesh and expansion frame are deployed to the expanded state, and the deformable segment of the cannula radially expands to transmit a full luminal volume of blood during bypass.

45. The cannula of claim 44, wherein the expansion frame is an inflation seal comprising a tubular balloon which encloses a chamber.

46. The cannula of claim 44, wherein the expansion frame is an umbrella comprising a plurality of arms.

47. The cannula of claim 46, wherein the arms are pivotally connected at a distal end of the arms to the distal end of the cannula, said arms having a proximal region attached to the first edge of the mesh, wherein during use, the proximal region of the arms expands radially outward when the arms are pivoted away from the cannula.

48. The cannula of claim 46, further comprising a flexible skirt attached circumferentially and continuously to the first edge of the mesh, said skirt adapted to seal against the inner lumen of the aorta during use.

49. The cannula of claim 44, wherein the cannula is a substantially cylindrical member which includes, at its proximal end, a fitting which is shaped for attachment to a bypass-oxygenator machine.

50. The cannula of claim 44, wherein the mesh further comprises a second edge which is in contact with the outer surface of the cannula, and wherein the lumen of the cannula extends through the mesh.

51. The cannula of claim 44, wherein the mesh is continuous, and wherein the lumen of the cannula terminates proximal of a distal tip of the mesh.

52. The cannula of claim 44, further comprising a flow diffuser attached to the distal end of the cannula for dispersing blood transmitted through the distal end of the cannula.

53. The arterial cannula of claim 52, wherein the flow diffuser is located inside the cannula lumen.

54. The arterial cannula of claim 52, wherein the flow diffuser is conical.

55. The arterial cannula of claim 52, wherein the flow diffuser is helical.

56. The arterial cannula of claim 52, when the flow diffuser is attached external to the cannula lumen by virtue of a structural support.

57. The arterial cannula of claim 52, wherein the flow diffuser is connected to the filter mesh by a shaft.

37. An arterial cannula with associated filter, comprising:

a cannula having an outer surface, a distal end adapted to enter an artery, a proximal end adapted to receive blood from a bypass-oxygenator machine, and a lumen which extends longitudinally from the proximal to the distal end;

an expansion frame attached to the cannula which is expandable between a compressed state and a radially expanded state; and

a mesh having a first edge attached circumferentially and continuously to the expansion frame;

wherein a segment of the cannula within the distal end is deformable and radially compresses to circumferentially receive a portion of the expansion frame to minimize the profile of the mesh and expansion frame when in the compressed state, wherein during use, the mesh and expansion frame are deployed to the expanded state, and the deformable segment of the cannula radially expands to transmit a full luminal volume of blood during bypass.