In vivo filter assembly

• US 20080172082A1
• Filed: 10/18/2006
• Published: 07/17/2008
• Est. Priority Date: 10/18/2006
• Status: Active Grant

• Current Assignee: InspireMD, Ltd.
• Original Assignee: InspireMD, Ltd.
• Inventors: Bar, Eli, Paz, Ofir, Holzer, Asher
• Granted Patent: US 8,043,323 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 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 2230/008 paraboloidal
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Disclosed is an assembly for filtering debris flowing in an in vivo fluid stream, the assembly comprising at least one balloon configured to volumetrically expand and, during at least a portion of the expansion, operatively connect with a filter, and to contract following the expansion. The assembly further comprising a filter configured to operatively connect with the at least one balloon during at least a portion of the volumetric expansion of the at least one balloon, such that the filter expands during the operative connection in order to filter debris from a fluid flowing in a fluid stream within which the expanded filter is disposed.

Claims

1. An assembly for filtering debris flowing in an in vivo fluid stream, the assembly comprising:

i) at least one balloon configured to volumetrically expand and, during at least a portion of said expansion, operatively connect with a filter, and to contract following said expansion;

ii) a filter configured to operatively connect with said at least one balloon during at least a portion of said volumetric expansion of said at least one balloon, such that said filter expands during said operative connection in order to filter debris from a fluid flowing in a fluid stream within which said expanded filter is disposed.

2. The assembly according to claim 1, wherein said at least one balloon comprises at least one proximal portion and at least one distal portion.

3. The assembly according to claim 2, wherein said at least one proximal portion of said at least one balloon operatively connects with said filter.

4. The assembly according to claim 2, wherein said at least one distal portion of said at least one balloon operatively connects with said filter.

5. The assembly according to claim 2, wherein a maximal expansion diameter of said at least one distal portion of said at least one balloon is greater than a maximal expansion diameter of said at least one proximal portion of said at least one balloon.

6. The assembly according to claim 2, wherein a maximal expansion diameter of said at least one proximal portion of said at least one balloon is greater than a maximal expansion diameter of said at least one distal portion of said at least one balloon.

7. The assembly according to claim 1, wherein said at least one balloon comprises at least one angioplasty balloon.

8. The assembly according to claim 1, wherein said at least one balloon comprises at least two balloons;

at least one first balloon and at least one second balloon.

9. The assembly according to claim 8, wherein said at least one first balloon is positioned proximally to said at least one second balloon.

10. The assembly according to claim 8, wherein said at least one first balloon has a maximal inflation diameter that is greater than a maximal inflation diameter of said at least one second balloon.

11. The assembly according to claim 1, wherein at least a portion of said filter is configured to removably connect to a luminal aspect associated with said fluid stream, in response to pressure of between at least about one atmosphere and no more than about 20 atmospheres.

12. The assembly according to claim 1, wherein at least a portion of said filter is configured to remain removably connected to a luminal aspect during said contraction of said at least one balloon.

13. The assembly according to claim 12, wherein said at least one balloon is configured to sequentially pass through at least two sequences of said expansion and contraction of said at least one balloon.

14. The assembly according to claim 13, wherein at least a portion of said filter is configured to remain removably connected to a luminal aspect associated with said fluid stream during at least a portion of said at least two sequences.

15. The assembly according to claim 12, including at least one cord operatively associated with said filter and configured to disconnect at least a portion of said filter from said luminal aspect when tension is applied to said at least one cord.

16. The assembly according to claim 15, wherein said at least a portion of said filter is configured to disconnect from said luminal aspect in response to tension applied to said at least one cord of at least about one Newton.

17. The assembly according to claim 15, wherein said at least a portion of said filter is configured to disconnect from said luminal aspect in response to tension applied to said at least one cord of no more than about 20 Newtons.

18. The assembly according to claim 1, wherein at least a portion of said filter includes a pressure-sensitive adhesive having an affinity for a tissue associated with an in vivo luminal aspect.

19. The assembly according to claim 18, wherein said adhesive is an adhesive from the group of adhesives comprising fibrin, biological glue, collagen, hydrogel, hydrocolloid, collagen alginate, and methylcellulose.

20. The assembly according to claim 18, wherein said at least a portion of said filter is configured to removably connect to a luminal aspect associated with said fluid stream, in response to pressure by said at least one balloon of between at least about one atmosphere and no more than about 20 atmospheres.

21. The assembly according to claim 20, wherein at least a portion of said filter is configured to remain removably connected to said luminal aspect during said contraction of said at least one balloon.

22. The assembly according to claim 21, wherein said at least one balloon is configured to sequentially pass through at least two sequences of said expansion and contraction of said at least one balloon.

23. The assembly according to claim 22, wherein said at least a portion of said filter is configured to remain removably connected to said luminal aspect during at least a portion said at least two sequences.

24. The assembly according to claim 21, including at least one cord operatively associated with said filter and configured to disconnect said at least a portion of said filter from said luminal aspect when tension is applied to said at least one cord.

25. The assembly according to claim 24, wherein said at least a portion of said filter is configured to disconnect from said luminal aspect in response to tension applied to said at least one cord of at least about one Newton.

26. The assembly according to claim 24, wherein said at least a portion of said filter is configured to disconnect from said luminal aspect in response to tension applied to said at least one cord of no more than about 20 Newtons.

27. The assembly according to claim 12, including a compression sleeve comprising a substantially curved wall having a proximal end, a distal end and a lumen extending from said proximal end to said distal end, said lumen having a cross sectional diameter that is substantially smaller than the maximal cross sectional diameter of said luminal aspect

28. The assembly according to claim 27, including at least one cord operatively associated with said filter, at least a portion of said at least one cord movingly juxtaposed within said compression sleeve lumen.

29. The assembly according to claim 28 wherein when said at least one cord operatively associated with said filter is held relatively stationary during a first distal moving of said compression sleeve, said filter is caused to disconnect from said luminal aspect.

30. The assembly according to claim 28, wherein in response to at least one second distal moving of said sleeve while said at least one cord is held relatively stationary, said filter is caused to radially contract such that a maximal cross sectional diameter of said filter is smaller that a cross sectional diameter of said sleeve lumen.

31. The assembly according to claim 30, wherein in response to at least one third distal moving of said sleeve while said at least one cord is held stationary, at least a portion of said filter is caused to enter said sleeve lumen.

32. The assembly according to claim 15, wherein:

i) said at least one balloon comprises an outer wall having a distal end and a proximal end and an inner wall defining a lumen, said lumen extending from said distal end to said proximal end; and

ii) at least a portion of said at least one cord is configured to slidingly pass through said lumen.

33. The assembly according to claim 32, wherein said at least one cord is configured to pull at least a portion of said filter into contact with said distal end of said at least one balloon.

34. The assembly according to claim 32, including a catheter having a distal end and a proximal end and a lumen extending from said distal end to said proximal end, wherein said at least one balloon proximal end is operatively associated with said distal end of said catheter.

35. The assembly according to claim 34, wherein said at least one balloon lumen is substantially continuous with said catheter lumen.

36. The assembly according to claim 34, wherein at least a portion of said at least one cord additionally extends through said catheter lumen.

37. The assembly according to claim 1, wherein said filter includes a distal portion, a proximal portion, an opening to said filter associated with said proximal portion and at least one strut operatively associated with said proximal portion.

38. The assembly according to claim 37, including at least one cord operatively associated with said at least one strut, such that at least a portion of said opening is configured to contract radially inwardly in response to tension applied to said at least one cord.

39. The assembly according to claim 38, wherein said at least one strut comprises at least two struts, at least one first strut and at least one second strut, said at least two struts being operatively associated with said at least one cord.

40. The apparatus according to claim 39, wherein said at least two struts are configured to resiliently flex outward with respect to a longitudinal axis passing through a center of said filter during at least a portion of said volumetric expansion of said at least one balloon.

41. The apparatus according to claim 40, wherein during at least a portion of said outward flexion of said at least two struts:

said at least one first strut forms at least one first radius; and

said at least one second strut forms at least one second radius, with respect to said longitudinal axis.

42. The assembly according to claim 38, wherein said at least one strut comprises at least six struts operatively associated with said at least one cord.

43. The assembly according to claim 38, wherein said at least one cord comprises at least two cords and said at least one strut comprises at least two struts.

44. The assembly according to claim 38, wherein said at least one cord comprises at least six cords and said at least one strut comprises at least six struts.

45. The assembly according to claim 1, wherein said at least one balloon includes an inflation channel in fluid communication with an interior portion of said at least one balloon, wherein said channel is configured to inflate at least a portion of said at least one balloon by introduction of a fluid through said inflation channel.

46. The assembly according to claim 45, including a catheter comprising a curved wall extending proximally from said at least one balloon and said inflation channel comprises a curved wall surrounding at least a portion of said catheter.

47. The assembly according to claim 1, wherein said at least one balloon comprises a material from the group consisting of:

rubber, silicon rubber, latex rubber, polyethylene, polyethylene terephthalate, and polyvinyl chloride.

48. The assembly according to claim 1, wherein said filter includes:

a) a distal portion;

b) a proximal portion;

c) an opening to said filter associated with said proximal portion; and

d) at least one cord guide channel circumferentially encircling at least a portion said proximal portion.

49. The assembly according to claim 48, wherein said filter comprises a flexible sheet material and said guide channel is formed from at least one of:

a bending of a portion of said sheet material; and

a shaped component attached to said sheet material.

50. The assembly according to claim 48, including at least one cord, at least a portion of said at least one cord passes through said guide channel, such that at least a portion of said opening is configured to contract radially inwardly in response to tension applied to said at least one cord.

51. The assembly according to claim 50, wherein said at least one cord channel comprises at least two cord channels and said at least one cord comprises at least two cords, said at least two cord channels being located substantially on the same cross sectional plane of said filter.

52. An assembly for filtering debris flowing in an in vivo fluid stream, the assembly comprising:

i) at least one balloon configured to volumetrically expand and, during at least a portion of said expansion, operatively connect with a filter, and, following said connection, to contract following said expansion; and

ii) a filter comprising a material having tissue connective properties for a portion of luminal tissue associated with an in vivo fluid stream, said filter positioned to operatively connect with said at least one balloon and removably connect to least a portion of said tissue and remain so connected during said contraction of said at least one balloon.

53. The assembly according to claim 52, wherein said at least one balloon comprises at least one proximal portion and at least one distal portion.

54. The assembly according to claim 53, wherein said operative connection between said at least one balloon and said filter occurs in said at least one proximal portion

55. The assembly according to claim 53, wherein said operative connection between said at least one balloon and said filter occurs in said at least one distal portion.

56. The assembly according to claim 53, wherein a maximal expansion diameter of said at least one distal portion is greater than a maximal expansion diameter of said at least one proximal portion.

57. The assembly according to claim 53, wherein a maximal expansion diameter of said at least one proximal portion is greater than a maximal expansion diameter of said at least one distal portion.

58. The assembly according to claim 52, wherein said at least one balloon comprises at least one angioplasty balloon.

59. The assembly according to claim 52, wherein said at least one balloon comprises at least two balloons;

at least one first balloon and at least one second balloon.

60. The assembly according to claim 59, wherein said at least one first balloon is positioned distally to said at least one second balloon.

61. The assembly according to claim 59, wherein said at least one first balloon has a first maximal inflation diameter that is greater than a maximal inflation diameter of said second balloon.

62. The assembly according to claim 59, wherein said at least one first balloon has a first maximal inflation diameter that is less than a maximal inflation diameter of said second balloon.

63. The assembly according to claim 52, wherein at least a portion of said filter is configured to removably connect to a luminal aspect associated with said fluid stream, in response to pressure of at least about one atmosphere and no more than about 20 atmospheres.

64. The assembly according to claim 52, wherein said at least one balloon is configured to sequentially pass through at least two sequences of said expansion and contraction of said at least one balloon.

65. The assembly according to claim 64, wherein at least a portion of said filter is configured to remain removably connected to a luminal aspect associated with said fluid stream during at least a portion of said at least two sequences.

66. The assembly according to claim 52, including at least one cord operatively associated with said filter and configured to disconnect at least a portion of said filter from a luminal aspect associated with said fluid stream when tension is applied to said at least one cord.

67. The assembly according to claim 66, wherein at least a portion of said filter is configured to disconnect from a luminal aspect associated with said fluid stream when said applied tension to said at least one cord is between at least about one Newton and no more than about 20 Newtons.

68. The assembly according to claim 67, wherein at least a portion of said filter includes a pressure-sensitive adhesive having an affinity for a tissue associated with an in vivo luminal aspect.

69. The assembly according to claim 68, wherein said adhesive is an adhesive from the group of adhesives comprising fibrin, biological glue, collagen, hydrogel, hydrocolloid, collagen alginate, and methylcellulose.

70. The assembly according to claim 68, wherein said at least a portion of said filter is configured to removably connect to a luminal aspect associated with said fluid stream, in response to pressure of between at least about one atmosphere and no more than about 20 atmospheres.

71. The assembly according to claim 70, wherein said at least one balloon is configured to contract following said expansion and said at least a portion of said filter is configured to remain removably connected to said luminal aspect during said at least one balloon contraction.

72. The assembly according to claim 71, wherein said at least one balloon is configured to sequentially pass through at least two sequences of said expansion and contraction of said at least one balloon.

73. The assembly according to claim 72, wherein said at least a portion of said filter is configured to remain removably connected to said luminal aspect during at least a portion said at least two sequences.

74. The assembly according to claim 71, including at least one cord operatively associated with said filter and configured to disconnect said at least a portion of said filter from said luminal aspect when tension is applied to said at least one cord.

75. The assembly according to claim 74, wherein said at least a portion of said filter is configured to disconnect from said luminal aspect in response to tension applied to said at least one cord of between at least about one Newton and no more than about 20 Newtons.

76. A method for collecting debris from a stenotic lesion associated with a primary stenotic vessel while preventing passage of the debris into a branch vessel branching from said primary vessel, the method comprising:

a) detecting said stenotic lesion in said primary stenotic vessel;

b) locating a filter in said primary stenotic vessel such that an opening of said filter is distal to a center of said stenotic lesion;

c) locating at least a proximal portion an angioplasty balloon proximal to said opening in said filter;

d) expanding said angioplasty balloon;

e) contacting said opening of said filter with at least a distal portion of said angioplasty balloon during said expanding;

f) causing said filter to open during said contacting;

g) generating debris from said stenotic lesion by said expanding of said angioplasty balloon;

h) capturing said debris in said filter;

i) preventing passage of said debris into said branch vessel by said contacting of said opening of said filter with said at least a distal portion of said angioplasty balloon;

j) contracting said angioplasty balloon; and

k) removing said angioplasty balloon from said primary stenotic vessel.

77. The method according to claim 76, further comprising, following step k:

l) contracting said filter.

78. The method according to claim 77, further comprising, following step l:

m) removing said filter from said primary stenotic vessel.

79. A method for collecting debris within a blood vessel, the method comprising:

a) juxtaposing an opening of an in vivo debris filter with at least one balloon;

b) expanding said at least one balloon in a blood vessel,

c) opening said filter during said expansion of said at least one balloon,

d) collecting debris within said filter;

e) disengaging said at least one balloon from said filter;

f) removing said at least one balloon from said vessel.

80. The method according to claim 79, further comprising, following step f:

g) contracting said filter; and

h) removing said filter from said blood vessel.

81. The method according to claim 79, further comprising contacting a stenotic vascular lesion during said expanding.

82. The method according to claim 81, further comprising compressing said lesion during said expanding.

83. The method according to claim 82, further comprising releasing debris from said lesion during said compressing.