Convertible embolic protection devices and methods of use

• US 8,480,702 B2
• Filed: 01/11/2008
• Issued: 07/09/2013
• Est. Priority Date: 01/11/2007
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Kusleika, Richard S., Ren, Brooke
• Primary Examiner(s): Hughes, S. Thomas
• Assistant Examiner(s): SHI, KATHERINE MENGLIN
• Application Number:
  US11/972,778
• Publication Number:
  US 20080172084A1
• Time in Patent Office: 2,006 Days
• Field of Search: 606104-107, 606/113, 606/127, 606/129, 606/159, 606/200, 623/1.11
• US Class Current: 606/200
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• 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 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

An embolic protection device for removing emboli from a blood vessel in a patient'"'"'s body. The device comprises a mesh element being expandable from a collapsed configuration to an expanded configuration and an elongate tubular element having a proximal opening, a distal opening, and a lumen between the proximal and distal openings. The lumen has a diameter large enough to slideably accommodate a standard guidewire. The mesh element is disposed on the elongate tubular element.

Claims

1. An embolic protection device for removing emboli from a blood vessel in a patient'"'"'s body, comprising:

a mesh element being expandable from a collapsed configuration to an expanded configuration;

an elongate tubular element having a proximal end having a proximal opening, a distal end having a distal opening, and a lumen between the proximal and distal openings, the lumen having a diameter large enough to slideably accommodate a standard guidewire; and

an elongate shaft having no lumen, the elongate shaft being attached to the proximal end of the elongate tubular element,

the mesh element being disposed on the elongate tubular element, and the mesh element being rotatable relative to the elongated tubular element when the mesh element is in the expanded configuration and no portion of the mesh element being in a fixed position relative to the elongate tubular member.

2. The device of claim 1, wherein the mesh element is slidable relative to the elongate tubular element when the mesh element is in the expanded configuration.

3. The device of claim 1, wherein the device further comprises a guidewire disposed within the lumen of the elongate tubular element.

4. The device of claim 3, wherein there are no stops on the guidewire.

5. The device of claim 1, wherein the lumen has a diameter of 0.025 cm to 0.097 cm.

6. The device of claim 1, wherein the lumen has a diameter of 0.064 cm±

0.005 cm.

7. The device of claim 1, wherein the lumen has a diameter of 0.053 cm±

0.005 cm.

8. The device of claim 1, wherein the lumen has a diameter of 0.043 cm±

0.005 cm.

9. The device of claim 1, wherein the lumen has a diameter of 0.038 cm±

0.005 cm.

10. The device of claim 1, wherein the lumen has a diameter of 0.029 cm±

0.005 cm.

11. The device of claim 1, wherein the elongate tubular element has an outer diameter of 0.030 cm to 0.100 cm.

12. The device of claim 1, wherein the elongate tubular element has an outer diameter of 0.089 cm to 0.036 cm.

13. The device of claim 1, wherein the mesh element has an interior portion and a portion of the elongate tubular element is disposed within the interior portion.

14. The device of claim 1, wherein the mesh element has a shape in the expanded configuration which defines an interior portion having a proximal facing opening.

15. The device of claim 1, wherein the mesh element is self-expanding.

16. The device of claim 1, wherein the mesh element is self-contracting.

17. The device of claim 1, wherein the mesh element is actively expanded.

18. The device of claim 1, wherein the mesh element is actively contracted.

19. The device of claim 1, wherein the mesh element is attached to a proximal sliding band and a distal sliding band and the sliding bands are coupled to the elongate tubular element.

20. The device of claim 19, wherein a stop is disposed on the elongate tubular element between the proximal and distal sliding bands and the stop restricts translation of the mesh element along the elongate tubular element.

21. The device of claim 1, wherein the mesh element is attached to a distal sliding band and the mesh element is attached to a strut which is attached to a proximal sliding band and the sliding bands are coupled to the elongate tubular element.

22. The device of claim 21, wherein a stop is disposed on the elongate tubular element between the proximal and distal sliding bands and the stop restricts translation of the mesh element along the elongate tubular element.

23. The device of claim 1, wherein the shaft has a diameter of 0.025 cm to 0.097 cm.

24. The device of claim 1, wherein a medical device for treatment or diagnosis is carried on the shaft.

25. The device of claim 1, wherein the mesh element is a filter.

26. The device of claim 25, wherein the filter comprises braided metal strands.

27. The device of claim 25, wherein the filter comprises a polymer film with holes.

28. The device of claim 1, wherein the mesh element is fully occlusive.

29. The device of claim 1, wherein the elongate tubular element has a distal portion and a coil is disposed on the distal portion of the elongate tubular element.

30. The device of claim 1, wherein the length of the shaft and the elongate tubular element together is from 60 cm to 320 cm.

31. The device of claim 30, wherein the length of the elongate tubular element is from 5 to 75 cm.

32. The device of claim 30, wherein the length of the elongate tubular element is from 10 to 40 cm.

33. The device of claim 1, wherein the length of the shaft and the elongate tubular element together is from 135 cm to 185 cm.

34. The device of claim 1, wherein the length of the shaft and the elongate tubular element together is from 280 cm to 320 cm.

35. The device of claim 1, wherein the mesh element expands to establish at least line contact with substantially all of a lumenal cross section of a 2 mm to 35 mm vessel.

36. The device of claim 1, wherein the mesh element expands to establish at least line contact with substantially all of a lumenal cross section of a 2 mm to 5 mm vessel.

37. The device of claim 1, wherein the elongate tubular element has a longitudinal axis and the proximal opening of the elongate tubular element is oriented at an angle of from 5 degrees to 65 degrees to the longitudinal axis of the elongate tubular element.

38. The device of claim 1, wherein the elongate tubular element has a longitudinal axis and the proximal opening of the elongate tubular element is oriented at an angle of from 30 degrees to 105 degrees to the longitudinal axis of the elongate tubular element.

39. The device of claim 1, wherein the elongate tubular element has a distal end and a soft tip is attached to the distal end of the elongate tubular element.

40. The device of claim 1, wherein the elongate tubular element has a distal region that comprises slots.

41. The device of claim 1, wherein the elongate tubular element has a distal region that comprises removed regions.

42. The device of claim 1, wherein the elongate tubular element has a distal region that comprises a coil tip.

43. The device of claim 1, wherein the elongate tubular element has a distal region that comprises a composite tip.

44. The device of claim 1, the device further comprises a sheath disposed over a portion of the mesh element.

45. The device of claim 44, wherein the sheath comprises a proximal shaft and a tubular portion having a lumen.

46. The device of claim 44, wherein the sheath comprises a proximal hub and a tubular portion having a lumen.

47. The device of claim 44, wherein the sheath comprises a proximal shaft and a tubular portion having a lumen and a skive.

48. The device of claim 44, wherein the sheath comprises a proximal shaft and a tubular portion having a lumen and two skives.

49. An embolic protection device for removing emboli from a blood vessel in a patient'"'"'s body, comprising:

a mesh element being expandable from a collapsed configuration to an expanded configuration;

an elongate tubular element having a proximal end having a proximal opening, a distal end having a distal opening, and a lumen between the proximal and distal openings, the lumen having a diameter large enough to slideably accommodate a standard guidewire; and

an elongate shaft having no lumen, the elongate shaft being attached to the proximal end of the elongate tubular element,

the mesh element being disposed on the elongate tubular element and the mesh element being attached to a proximal band and a distal band, the bands being coupled to the elongate tubular element, and one of the proximal and distal bands being fixed to the elongate tubular element and one of the proximal and distal bands being slidable on the elongate tubular element.

50. The device of claim 49, wherein an actuating wire or tube is attached to the slidable band.

51. The device of claim 49, wherein the proximal band is fixed and the distal band is slidable.

52. An embolic protection device for removing emboli from a blood vessel in a patient'"'"'s body, comprising:

a mesh element being expandable from a collapsed configuration to an expanded configuration;

an elongate tubular element having a proximal end having a proximal opening, a distal end having a distal opening, and a lumen between the proximal and distal openings, the lumen having a diameter large enough to slideably accommodate a standard guidewire; and

an elongate shaft having no lumen, the elongate shaft being attached to the proximal end of the elongate tubular element,

the mesh element being disposed on the elongate tubular element and the mesh element being attached to a distal band and the mesh element being attached to a strut which is attached to a proximal band, the bands being coupled to the elongate tubular element, and one of the proximal and distal bands being fixed to the elongate tubular element and one of the proximal and distal bands being slidable on the elongate tubular element.

53. The device of claim 52, wherein an actuating wire or tube is attached to the slidable band.

54. The device of claim 52, wherein the proximal band is fixed and the distal band is slidable.

55. An embolic protection device for removing emboli from a blood vessel in a patient'"'"'s body, comprising:

a mesh element being expandable from a collapsed configuration to an expanded configuration; and

an elongate tubular element having a proximal end having a proximal opening, a distal end having a distal opening, and a lumen between the proximal and distal openings, the lumen having a diameter large enough to slideably accommodate a standard guidewire,

the mesh element being disposed on the elongate tubular element and the mesh element being rotatable relative to the elongate tubular element when the mesh element is in the expanded configuration, and no portion of the mesh element being in a fixed position relative to the elongate tubular member.

56. The device of claim 55, wherein the mesh element is slidable relative to the elongate tubular element when the mesh element is in the expanded configuration.

57. The device of claim 55, wherein the length of the elongate tubular element is from 60 to 320 cm.

58. The device of claim 55, wherein the device further comprises a guidewire disposed within the lumen of the elongate tubular element.

59. The device of claim 55, wherein the lumen has a diameter of 0.025 cm to 0.097 cm.

60. The device of claim 55, wherein the mesh element is a filter.

61. The device of claim 55, wherein the mesh element is fully occlusive.

62. An embolic protection device for removing emboli from a blood vessel in a patient'"'"'s body, comprising:

a mesh element being expandable from a collapsed configuration to an expanded configuration;

a first elongate tubular element having a proximal end having a proximal opening, a distal end having a distal opening, and a lumen between the proximal and distal openings, the lumen having a diameter large enough to slideably accommodate a standard guidewire; and

a second elongate tubular element having a proximal end having a proximal opening, a distal end having a distal opening, and a lumen between the proximal and distal openings, the lumen having a diameter large enough to slideably accommodate a standard guidewire,

a distal region including the distal end of the second elongate tubular element being disposed in a portion of the lumen of the first elongate tubular element,

a first portion of the mesh element being fixed to the first elongate tubular element and a second portion of the mesh element being fixed to the second elongate tubular element, the mesh element being expandable from a collapsed configuration to an expanded configuration by movement of the first and second elongate tubular elements relative to each other.

63. The device of claim 62, wherein the mesh element is expandable from a collapsed configuration to an expanded configuration by axial movement of the first and second elongate tubular elements relative to each other.

64. The device of claim 62, wherein the mesh element is expandable from a collapsed configuration to an expanded configuration by rotational movement of the first and second elongate tubular elements relative to each other.

65. The device of claim 62, wherein the length of the device is from 60 to 320 cm.

66. The device of claim 62, wherein the device further comprises a guidewire disposed within the lumens of the first and second elongate tubular elements.

67. The device of claim 62, wherein the lumens of the first and second elongate tubular elements each independently have diameters of 0.025 cm to 0.097 cm.

68. The device of claim 62, wherein the mesh element is a filter.

69. The device of claim 62, wherein the mesh element is fully occlusive.

70. A method for removing emboli from a blood vessel in a patient'"'"'s body comprising:

providing an embolic protection device comprising;

a mesh element being expandable from a collapsed configuration to an expanded configuration;

an elongate tubular element having a proximal end having a proximal opening, a distal end having a distal opening, and a lumen between the proximal and distal openings, the lumen having a diameter large enough to slideably accommodate a standard guidewire; and

an elongate shaft having no lumen, the elongate shaft being attached to the proximal end of the elongate tubular element, and

the mesh element being disposed on the elongate tubular element, and the mesh element being rotatable relative to the elongate tubular element when the mesh element is in the expanded configuration and no portion of the mesh element being in a fixed position relative to the elongate tubular member; and

introducing the embolic protection device into a vessel in the patient'"'"'s body.

71. The method of claim 70, further comprising advancing the embolic protection device through the vessel until the mesh element is positioned at a desired location distal to a treatment site and deploying the mesh element to its expanded configuration.

72. The method of claim 70, wherein the device further comprises a guidewire disposed within the lumen of the elongate tubular element.

73. The method of claim 72, wherein the guidewire is removed and replaced with a second guidewire.

74. The method of claim 70, wherein the lumen has a diameter of 0.025 cm to 0.097 cm.

75. The method of claim 70, wherein the device further comprises a sheath disposed over a portion of the mesh element.

76. The method of claim 75, further comprising advancing the embolic protection device through the vessel until the mesh element is positioned at a desired location distal to a treatment site and deploying the mesh element to its expanded configuration by removing the sheath from the mesh element.

77. The method of claim 70, wherein a guide catheter or guide lumen is advanced into the vessel in the patient'"'"'s body to assist in introducing the embolic protection device.

78. The method of claim 70, wherein a recovery catheter is used to recover the embolic protection device.

79. The method of claim 70, further comprising advancing a medical device for diagnosis or treatment over the shaft.