Embolic protection systems

• US 20070225750A1
• Filed: 03/07/2007
• Published: 09/27/2007
• Est. Priority Date: 03/10/2006
• Status: Abandoned Application

• Current Assignee: ev3, Inc. (Medtronic Plc)
• Original Assignee: ev3, Inc. (Medtronic Plc)
• Inventors: Kusleika, Richard, Ren, Brooke, Lininger, James
• Application Number:
  US11/715,266
• Publication Number:
  US 20070225750A1
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

An embolic protection device comprising an expandable structure and a catheter. The catheter has a distal region and a working channel dimensioned to slideably receive an interventional device. The expandable structure is attached to the distal region of the catheter. The expandable structure has an expandable working channel extension and a working channel opening, the expandable working channel extension has a proximal end and a distal end, the proximal end of the working channel extension is attached to a distal end of the working channel, and the distal end of the working channel extension forms the working channel opening. The working channel opening is disposed proximate an exterior surface of the expandable structure when the expandable structure is expanded. The working channel, working channel extension, and the working channel opening form a continuous lumen.

Claims

1. An embolic protection device comprising an expandable structure and a catheter, the catheter having a distal region and having a working channel dimensioned to slideably receive an interventional device, the expandable structure being attached to the distal region of the catheter, the expandable structure having an expandable working channel extension and a working channel opening, the expandable working channel extension having a proximal end and a distal end, the proximal end of the working channel extension being attached to a distal end of the working channel, the distal end of the working channel extension forming the working channel opening, the working channel opening being disposed proximate an exterior surface of the expandable structure when the expandable structure is expanded, and the working channel, working channel extension, and the working channel opening forming a continuous lumen.

2. The embolic protection device of claim 1, wherein the expandable structure comprises a flow channel.

3. The embolic protection device of claim 1, wherein the expandable structure has a generally cylindrical shape.

4. The embolic protection device of claim 2, wherein the expandable structure has a generally tubular shape.

5. The embolic protection device of claim 2, wherein the catheter has a longitudinal axis and when the expandable structure is expanded, the flow channel has a cross-sectional area in a plane normal to the longitudinal axis that is 20 to 90 percent of the cross-sectional area of the expandable structure.

6. The embolic protection device of claim 2, wherein the catheter has a longitudinal axis and when the expandable structure is expanded, the flow channel has a cross-sectional area in a plane normal to the longitudinal axis that is 50 to 90 percent of the cross-sectional area of the expandable structure.

7. The embolic protection device of claim 2, wherein the catheter has a longitudinal axis and when the expandable structure is expanded, the flow channel has a cross-sectional area in a plane normal to the longitudinal axis that is 75 to 90 percent of the cross-sectional area of the expandable structure.

8. The embolic protection device of claim 1, wherein the expandable structure is an actively expanded structure.

9. The embolic protection device of claim 8, wherein the expandable structure is an inflatable balloon.

10. The embolic protection device of claim 1, wherein the expandable structure is self-expanding.

11. The embolic protection device of claim 10, wherein the expandable structure is a mesh covered by a membrane.

12. The embolic protection device of claim 11, wherein the expandable structure is a laser-cut, open mesh nitinol tube covered by a thin layer of silicone polymer.

13. The embolic protection device of claim 2, wherein the expandable structure, when expanded in a first blood vessel, is able to stop blood flow through a second blood vessel and able to allow blood to flow through the first blood vessel, and the working channel opening is able to be disposed to allow an interventional device to enter the second blood vessel.

14. The embolic protection device of claim 1, wherein the working channel extension and the working channel meet at an angle of from 75 to 105 degrees.

15. The embolic protection device of claim 1, wherein the working channel extension and the working channel meet at an angle of approximately 90 degrees.

16. The embolic protection device of claim 1, wherein the catheter comprises a guidewire lumen.

17. The embolic protection device of claim 1, wherein the working channel has an internal diameter of from 0.030 cm to 0.51 cm.

18. The embolic protection device of claim 17, wherein the fully expanded working channel extension and the fully expanded working channel opening have an internal diameter of from 0.030 cm to 0.51 cm.

19. The embolic protection device of claim 1, wherein the working channel has an internal diameter of from 0.10 cm to 0.28 cm.

20. The embolic protection device of claim 19, wherein the fully expanded working channel extension and the fully expanded working channel opening have an internal diameter of from 0.10 cm to 0.28 cm.

21. The embolic protection device of claim 1, wherein the working channel has an internal diameter of from 0.15 cm to 0.24 cm.

22. The embolic protection device of claim 21, wherein the fully expanded working channel extension and the fully expanded working channel opening have an internal diameter of from 0.15 cm to 0.24 cm.

23. The embolic protection device of claim 1, wherein the working channel has an internal diameter of 0.23 cm.

24. The embolic protection device of claim 23, wherein the fully expanded working channel extension and the fully expanded working channel opening have an internal diameter of 0.23 cm.

25. The embolic protection device of claim 1, wherein the working channel has an internal diameter of 0.18 cm.

26. The embolic protection device of claim 25, wherein the fully expanded working channel extension and the fully expanded working channel opening have an internal diameter of 0.18 cm.

27. The embolic protection device of claim 1, wherein one or more radiopaque marker bands are located near the distal end of the working channel.

28. The embolic protection device of claim 1, wherein one or more radiopaque marker bands are located near the distal end of the working channel extension.

29. The embolic protection device of claim 1, wherein the device further comprises a retractable sheath that can be placed over the expandable structure.

30. A method for positioning an embolic protection device within a patient'"'"'s vasculature, the method comprising:

providing an embolic protection device of claim 1;

advancing the embolic protection device to a target site within the patient'"'"'s vasculature; and

expanding the expandable structure within the patient'"'"'s vasculature.

31. The method of claim 30, wherein the expandable structure comprises a flow channel.

33. The method of claim 31, wherein the catheter has a longitudinal axis and when the expandable structure is expanded, the flow channel has a cross-sectional area in a plane normal to the longitudinal axis that is 20 to 90 percent of the cross-sectional area of the expandable structure.

34. The method of claim 31, wherein the catheter has a longitudinal axis and when the expandable structure is expanded, the flow channel has a cross-sectional area in a plane normal to the longitudinal axis that is 50 to 90 percent of the cross-sectional area of the expandable structure.

35. The method of claim 31, wherein the catheter has a longitudinal axis and when the expandable structure is expanded, the flow channel has a cross-sectional area in a plane normal to the longitudinal axis that is 75 to 90 percent of the cross-sectional area of the expandable structure.

36. The method of claim 30, wherein the expandable structure is an actively expanded structure.

37. The method of claim 36, wherein the expandable structure is an inflatable balloon.

38. The method of claim 30, wherein the expandable structure is self-expanding.

39. The method of claim 38, wherein the expandable structure is a mesh covered by a membrane.

40. The method of claim 39, wherein the expandable structure is a laser-cut, open mesh nitinol tube covered by a thin layer of silicone polymer.

41. The method of claim 31, wherein the expandable structure is expanded in a first blood vessel, and stops blood flow through a second blood vessel and allows blood to flow through the first blood vessel, and the working channel opening is disposed to allow an interventional device to enter the second blood vessel.

42. The method of claim 31, wherein the catheter comprises a guidewire lumen.

43. The method of claim 30, wherein a second catheter is introduced into the working channel, working channel extension, and working channel opening, and an interventional device is introduced into a lumen of the second catheter.

44. The method of claim 41, wherein an interventional device is introduced into the second blood vessel and the blood in the second blood vessel is subsequently aspirated.

32. The method of claim 32, wherein the expandable structure has a generally tubular shape.

45. An embolic protection device comprising an expandable structure and a catheter, the catheter having a distal region and having a working channel, the working channel having a working channel opening disposed in the distal region of the catheter, the working channel and the working channel opening dimensioned to slideably receive an interventional device, the working channel having a distal region, at least a portion of the distal region of the working channel being disposed within the expandable structure, the expandable structure, when expanded in a first blood vessel, is able to stop blood flow through a second blood vessel and able to allow blood to flow through the first blood vessel, and the working channel opening is able to be disposed to allow an interventional device to enter the second blood vessel.

46. The embolic protection device of claim 45, wherein the expandable structure comprises a flow channel.

47. The embolic protection device of claim 46, wherein the expandable structure has a generally tubular shape.

48. The embolic protection device of claim 46, wherein the expandable structure comprises two expandable rings joined by a membrane.

49. The embolic protection device of claim 45, wherein the expandable structure is a mesh, the mesh having a portion covered by a membrane that prevents flow and having a portion not covered by a membrane so flow can occur through the mesh.

50. The embolic protection device of claim 49, wherein the expandable structure is self-expanding.

51. The embolic protection device of claim 50, wherein the expandable structure is a laser-cut, open mesh nitinol tube having a portion covered by a thin layer of silicone polymer.

52. The embolic protection device of claim 49, wherein the expandable structure has a distal portion and a proximal portion, and when the expandable structure is expanded the distal portion is generally tubular and the proximal portion is tapered.

53. The embolic protection device of claim 45, wherein the expandable structure comprises three or more sealing arms, a membrane attached to the three or more sealing arms, and three or more support arms.

54. The embolic protection device of claim 53, wherein the sealing arms are made of self-expanding metal.

55. The embolic protection device of claim 53, wherein the working channel opening is disposed within the expandable structure.

56. The embolic protection device of claim 45, further comprising a second catheter that can be introduced into the working channel, working channel extension, and working channel opening, the second catheter having a lumen that can be used to deliver an interventional device.

57. The embolic protection device of claim 46, wherein the catheter has a longitudinal axis and when the expandable structure is expanded, the flow channel has a cross-sectional area in a plane normal to the longitudinal axis that is 20 to 90 percent of the cross-sectional area of the expandable structure.

58. The embolic protection device of claim 46, wherein the catheter has a longitudinal axis and when the expandable structure is expanded, the flow channel has a cross-sectional area in a plane normal to the longitudinal axis that is 50 to 90 percent of the cross-sectional area of the expandable structure.

59. The embolic protection device of claim 46, wherein the catheter has a longitudinal axis and when the expandable structure is expanded, the flow channel has a cross-sectional area in a plane normal to the longitudinal axis that is 75 to 90 percent of the cross-sectional area of the expandable structure.

60. The embolic protection device of claim 45, wherein the expandable structure is self-expanding.

61. The embolic protection device of claim 45, wherein the catheter comprises a guidewire lumen.

62. The embolic protection device of claim 45, wherein the working channel has an internal diameter of from 0.030 cm to 0.51 cm.

63. The embolic protection device of claim 45, wherein the working channel has an internal diameter of from 0.10 cm to 0.28 cm.

64. The embolic protection device of claim 45, wherein the working channel has an internal diameter of from 0.15 cm to 0.24 cm.

65. The embolic protection device of claim 45, wherein the device further comprises a retractable sheath that can be placed over the expandable structure.

66. A method for positioning an embolic protection device within a patient'"'"'s vasculature, the method comprising:

providing an embolic protection device of claim 45;

advancing the embolic protection device to a target site within the patient'"'"'s vasculature; and

expanding the expandable structure within the patient'"'"'s vasculature.

67. The method of claim 66, wherein the expandable structure comprises a flow channel.

68. The method of claim 67, wherein the expandable structure is expanded in a first blood vessel, and stops blood flow through a second blood vessel and allows blood to flow through the first blood vessel, and the working channel opening is disposed to allow an interventional device to enter the second blood vessel.

69. The method of claim 68, wherein an interventional device is introduced into the second blood vessel and the blood in the second blood vessel is subsequently aspirated.