Non-occluding dilation device

• US 20080058856A1
• Filed: 06/19/2007
• Published: 03/06/2008
• Est. Priority Date: 06/28/2005
• Status: Abandoned Application

• Current Assignee: LeMaitre Vascular, Incorporated
• Original Assignee: LeMaitre Vascular, Incorporated
• Inventors: Ramaiah, Venkatesh, McNutt, Robert
• Application Number:
  US11/820,726
• Publication Number:
  US 20080058856A1
• Time in Patent Office: Days
• US Class Current: 606/198
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A device for dilating a vessel or a structure (such as a stent or stent graft) within a vessel comprises a plurality of wires that are spaced apart when the device is dilated so as to allow fluid to flow through the device. Thus, when in use the device does not occlude or substantially hinder the flow of blood through a vessel or into side vessels.

Claims

1. A device for dilating a vessel or a structure positioned within a vessel, the device comprising a plurality of wires that are spaced apart when the device is dilated to allow for the passage of fluid through the device, the device being sufficiently compliant so that when placed into a vessel and dilated it can conform to at least one diameter disparity ratio of between 1.2:

1 and 3.0;

1.

2. The device of claim 1 that can conform to a diameter disparity ratio of 1.2:

1.

3. The device of claim 1 that can conform to a diameter disparity ratio of 1.4:

1.

4. The device of claim 1 that can conform to a diameter disparity ratio of 1.6:

1.

5. The device of claim 1 that can conform to a diameter disparity ratio of 1.8:

1.

6. The device of claim 1 that can conform to a diameter disparity ratio of 2.0:

1.

7. The device of claim 1 that can conform to a diameter disparity ratio of 2.2:

1.

8. The device of claim 1 that can conform to a diameter disparity ratio of 2.4:

1.

9. The device of claim 1 that can conform to a diameter disparity ratio of 2.6:

1.

10. The device of claim 1 that can conform to a diameter disparity ratio of 2.8:

1.

11. The device of claim 1 that can conform to a diameter disparity ratio of 3.0:

1.

12. The device of claim 1 wherein the wires are formed in a criss-cross pattern.

13. The device of claim 1 wherein each of the wires are parallel to the vessel flow path when in the vessel.

14. The device of claim 1 wherein at least some of the wires form a criss-cross pattern.

15. The device of claim 1 wherein the wires are comprised of nitinol.

16. The device of claim 1 wherein the wires have a circular cross-sectional and a diameter of between 0.008″

and 0.012″

.

17. The device of claim 1 that further includes a permeable membrane on at least part of the device.

18. The device of claim 17 wherein the device has an outer surface and the permeable membrane is positioned on the outer surface.

19. A catheter including the device of claim 1 and comprising a sheath that at least partially encloses the device during insertion of the device into the vessel, the device being preshaped to automatically expand when released from the sheath.

98. The device of claim 1 that includes a proximal end and a distal end and that is dilated by decreasing the distance between the proximal end and the distal end.

20. A device for dilating two vessels or a structure positioned within two vessels, the device comprising a plurality of wires that are spaced apart when the device is dilated to allow for the passage of fluid through the device, the device being sufficiently compliant so that when it is simultaneously positioned in each of the two vessels it can conform to at least one multi-vessel diameter disparity ratio of between 1.2:

1 and 3.0;

1.

21. The device of claim 20 that can conform to a multi-vessel diameter disparity ratio of 1.2:

1.

22. The device of claim 20 that can conform to a multi-vessel diameter disparity ratio of 1.4:

1.

23. The device of claim 20 that can conform to a multi-vessel diameter disparity ratio of 1.6:

1.

24. The device of claim 20 that can conform to a multi-vessel diameter disparity ratio of 1.8:

1.

25. The device of claim 20 that can conform to a multi-vessel diameter disparity ratio of 2.0:

1.

26. The device of claim 20 that can conform to a multi-vessel diameter disparity ratio of 2.2:

1.

27. The device of claim 20 that can conform to a multi-vessel diameter disparity ratio of 2.4:

1.

28. The device of claim 20 that can conform to a multi-vessel diameter disparity ratio of 2.6:

1.

29. The device of claim 20 that can conform to a multi-vessel diameter disparity ratio of 2.8:

1.

30. The device of claim 20 that can conform to a multi-vessel diameter disparity ratio of 3.0:

1.

31. The device of claim 20 wherein each of the wires are parallel to the vessel flow path when in the vessel.

32. The device of claim 20 wherein at least some of the wires are formed in a criss-cross pattern.

33. A catheter including the device of claim 20 and comprising a sheath that at least partially encloses the device during insertion of the device into the vessel, the device being preshaped to automatically expand when released from the sheath.

34. The device of claim 20 wherein the wires are comprised of nitinol.

35. The device of claim 20 wherein the wires have a circular cross-section and a diameter of between 0.008″

and 0.012″

.

36. The device of claim 20 that further includes a permeable membrane on at least part of the device.

37. The device of claim 36 wherein the device has an outer surface and the permeable membrane is positioned on the outer surface.

50. The device of claim 37 wherein the body portion includes a band in which the size of the spaces between the wires in the band is less than the size of the spaces in the rest of the body portion.

99. The device of claim 20 that includes a proximal end and a distal end and that is dilated by decreasing the distance between the proximal end and the distal end.

38. A device for dilating a vessel or a structure within a vessel, the device comprising a plurality of wires that are spaced apart when the device is dilated to allow for the passage of fluid through the device, the device comprising:

(a) a distal end;

(b) a proximal end; and

(c) a body portion between the distal end and the proximal end;

wherein at least some of the spaces between the wires in the body portion are larger than the spaces between the wires at the distal end or the proximal end when the device is dilated within a vessel, so as to allow fluid to flow into side vessels if the device is positioned against a side vessel.

39. The device of claim 38 wherein at least some of the spaces between the wires in the body portion have an area of no greater than 1 mm² when the device is dilated.

40. The device of claim 38 wherein at least some of the spaces between the wires in the body portion have an area of no greater than 5 mm² when the device is dilated.

41. The device of claim 38 wherein at least some of the spaces between the wires in the body portion have an area of no greater than 10 mm² when the device is dilated.

42. The device of claim 38 wherein at least some of the spaces between the wires in the body portion have an area of no greater than 25 mm² when the device is dilated.

43. The device of claim 38 wherein at least some of the spaces between the wires in the body portion have an area of no greater than 50 mm² when the device is dilated.

44. The device of claim 38 wherein at least some of the spaces between the wires in the body portion have an area of no greater than 100 mm² when the device is dilated.

45. The device of claim 38 wherein at least some of the spaces between the wires in the body portion have an area of no greater than 200 mm² when the device is dilated.

46. The device of claim 38 wherein the wires are comprised of nitinol.

47. The device of claim 38 wherein the wires have a circular cross-sectional and a diameter of between 0.008″

and 0.012″

.

48. The device of claim 38 that further includes a permeable membrane on at least part of the device.

49. The device of claim 48 wherein the device has an outer surface and the permeable membrane is positioned on the outer surface.

51. A catheter including the device of claim 38 and comprising a sheath that at least partially encloses the device during insertion of the device into the vessel, the device being preshaped to automatically expand when released from the sheath.

97. The device of claim 38 wherein at least some of the spaces between the wires in the body portion have an area of no greater than 400 mm² when the device is fully dilated.

100. The device of claim 38 that includes a proximal end and a distal end and that is dilated by decreasing the distance between the proximal end and the distal end.

52. A device for dilating a vessel or a structure within a vessel, the device comprising a plurality of wires that are spaced apart when the device is dilated to allow for the passage of fluid through the device, the wires being parallel to each other and being parallel to the vessel flow path when in the vessel.

53. The device of claim 52 that includes at least four spaced-apart wires.

54. The device of claim 52 that includes at least six spaced-apart wires.

55. The device of claim 52 that includes at least eight spaced-apart wires.

56. The device of claim 52 that includes at least ten spaced-apart wires.

57. The device of claim 52 that includes at least twelve spaced-apart wires.

58. The device of claim 52 that includes at least fourteen spaced-apart wires.

59. The device of claim 52 that includes at least sixteen spaced-apart wires.

60. The device of claim 52 that includes at least eighteen spaced-apart wires.

61. The device of claim 52 that includes at least twenty spaced-apart wires.

62. The device of claim 52 that includes at least twenty-four spaced-apart wires.

63. The device of claim 52 wherein the maximum space between each wire when the device is fully dilated is between 1 mm and 2 mm.

64. The device of claim 52 wherein the maximum space between each wire when the device is fully dilated is between 2 mm and 3 mm.

65. The device of claim 52 wherein the maximum space between each wire when the device is fully dilated is between 3 mm and 4 mm.

66. The device of claim 52 wherein the maximum space between each wire when the device is fully dilated is between 4 mm and 6 mm.

67. The device of claim 52 wherein the maximum space between each wire when the device is fully dilated is between 6 mm and 8 mm.

68. The device of claim 52 wherein the maximum space between each wire when the device is fully dilated is between 8 mm and 10 mm.

69. The device of claim 52 wherein the maximum space between each wire when the device is fully dilated is between 10 mm and 25 mm.

70. The device of claim 52 wherein the maximum space between each wire when the device is fully dilated is between 25 mm and 50 mm.

71. The device of claim 52 wherein the maximum space between each wire when the device is fully dilated is between 50 mm and 100 mm.

72. The device of claim 52 wherein each wire is a slat.

73. The device of claim 52 that further includes a permeable membrane on at least part of the device.

74. The device of claim 73 wherein the device has an outer surface and the permeable membrane is positioned on the outer surface.

75. A catheter including the device of claim 52 and comprising a sheath that at least partially encloses the device during insertion of the device into the vessel, the device being preshaped to automatically expand when released from the sheath.

78. The device of claim 72 wherein the wires have a circular cross section and are between 0.008″

and 0.012″

in diameter.

79. The device of claim 72 wherein at lest some of the wires form a criss-cross pattern, the device has a body portion and the space between at least some of the wires in the body portion is between 2 mm² and 400 mm² when the device is fully dilated.

101. The device of claim 52 that includes a proximal end and a distal end and that is dilated by decreasing the distance between the proximal end and the distal end.

76. A device for dilating a vessel or a structure within a vessel, the device comprising a plurality of wires that are spaced apart when the device is dilated to allow for the passage of fluid through the device, wherein the device before being dilated has a kink radius of greater than or equal to 13.5 mm.

77. The device of claim 76 wherein at least some of the wires are comprised of nitinol.

80. A device for dilating a vessel or a structure within a vessel, the device comprising a plurality of wires that are spaced apart when the device is dilated to allow for the passage of fluid through the device, wherein the device when fully dilated has kink radius of greater than or equal to 16 mm.

81. The device of claim 80 wherein the device has kink radius of greater than or equal to 20 mm when the device is fully dilated.

82. The device of claim 80 wherein the wires are comprised of nitinol.

83. The device of claim 80 wherein the wires have a circular cross section and are between 0.008″

and 0.012″

in diameter.

84. The device of claim 80 wherein at least some of the wires form a criss-cross pattern, the device has a body portion and the space between at least some of the wires in the body portion is between 2 mm² and 400 mm² when the device is fully dilated.

85. A device for dilating a vessel or structure within a vessel, the device comprising a plurality of wires that are spaced apart when the device is dilated to allow for the passage of fluid through the device, wherein when the device is positioned against a side vessel the pressure drop in the side vessel is less than 70% when the device is dilated, as measured in a pressure monitoring test utilizing water.

86. The device of claim 85 wherein the pressure drop is less than 60%.

87. The device of claim 85 wherein the pressure drop is less than 50%.

88. The device of claim 85 wherein the pressure drop is less than 40%.

89. The device of claim 85 wherein the pressure drop is less than 30%.

90. The device of claim 85 wherein the pressure drop is less than 20%.

91. The device of claim 85 wherein the pressure drop is less than 10%.

92. The device of claim 85 wherein the pressure drop is less than 5%.

93. The device of claim 85 wherein the pressure drop is less than 2%.

94. The device of claim 85 wherein the pressure drop is less than 1%.

95. A device for dilating a vessel or a structure within a vessel, the device comprising a plurality of wires that are spaced apart when the device is dilated to allow for the passage of blood through the device, the device capable of conforming to incongruent vessel shapes.

96. A device for dilating a vessel or structure within a vessel, the device comprising a plurality of wires that are spaced apart when the device is dilated to allow for the passage of fluid through the device, the device being sufficiently compliant so that when placed into a vessel it can conform to one or more diameter disparity ratios between 1.2:

1 and 3.0;

1, and can conform to one or more multi-vessel diameter disparity ratios between 1.2;

1 and 3.0;

1, wherein the device includes a distal end, a proximal end and a body portion between the distal end and the proximal end and spaces between the wires wherein at least some of the spaces between the wires in the body portion are larger than the spaces between the wires at the distal end or the proximal end when the device is dilated.