Containers and methods for delivering vaso-occluding filaments and particles

• US 20040098024A1
• Filed: 03/25/2003
• Published: 05/20/2004
• Est. Priority Date: 03/25/2002
• Status: Abandoned Application

• Current Assignee: Stryker Corporation
• Original Assignee: Concentric Medical, Inc. (Stryker Corporation)
• Inventors: Valley, Kristen, French, Ron, Sepetka, Ivan, Miller, John, Dieck, Martin S., Pierce, Ryan K., Helkowski, Richard A.
• Application Number:
  US10/400,185
• Publication Number:
  US 20040098024A1
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40

Abstract

Containers for holding and delivering vaso-occluding materials, such as hydrogel particles and filaments include a fluid inlet port and a fluid outlet port that are respectively fluidly connectable with a fluid source and a delivery catheter. The vaso-occlusive materials may be held in the container in a hydrated or unhydrated state. The container further includes at least one chamber or passageway extending therebetween. The passageway may be straight, curved, spiral, helical, narrow or otherwise shaped. The chamber may also have sections of varying cross section such as a ramped section. The shapes of the passageways of the container help organize ejection of the vaso-occluding materials minimizing contamination and clumping.

Claims

1. A kit for holding vaso-occluding elements comprising:

a plurality of hydratable vaso-occluding elements; and

a container adapted to hold the hydratable vaso-occluding elements, said container having an inlet port and an outlet port, wherein at least one of the fluid inlet and outlet ports is adapted for fluid connection with a fluid source.

2. The kit of claim 1 wherein the container comprises a chamber to hold said elements, said chamber having a varying cross sectional area.

3. The kit of claim 2 wherein said varying cross sectional area decreases in a direction from the inlet port to the outlet port.

4. The kit of claim 2 wherein said chamber has a first section and a second section and wherein said first section has a first cross sectional area and said second section has a second cross sectional area different than said first cross sectional area.

5. The kit of claim 4 wherein said second cross sectional area decreases in a direction towards the fluid output port.

6. The kit of claim 5 wherein said first cross sectional area is constant.

7. The kit of claim 1 comprising at least one passageway, said passageway being adapted to allow a controlled number of elements to pass therethrough at a time.

8. The kit of claim 7 wherein said passageway is straight.

9. The kit of claim 7 wherein said passageway is curved.

10. The kit of claim 9 wherein said passageway has one of a spiral or helical shape.

11. The kit of claim 1 wherein said elements are particles and the container further comprises a mixing member, said mixing member being elongate and having a first section outside of said container and a second section within said container for stirring said particles.

12. The kit of claim 11 wherein said second section of said mixing member includes fingers and wherein said mixing member is rotatable.

13. The kit of claim 1 wherein said container comprises a conical distal section, said conical distal section decreasing in diameter and terminating at said fluid output port.

14. The kit of claim 13 wherein said conical distal section is adapted to fit within a proximal end of a delivery catheter.

15. The kit of claim 1 further comprising a one-way valve positioned at at least one of said fluid inlet port and fluid output port wherein when said one-way valve is disposed at said fluid inlet port the valve permits flow only into said container and when said valve is positioned at said fluid output port said valve permits flow only out of said container.

16. The kit of claim 1 wherein said elements are particles and said container further comprises first chamber in fluid communication with said inlet port and a second chamber in fluid communication with said outlet port, said first chamber and said second chamber separated by a support member having at least one opening and said at least one opening being larger than said particles such that when said at least one opening is not covered, fluid and said particles may pass through, said container further comprising a movable screen positioned across said support, said screen having at least one particle-blocking section and at least one particle-passing section, said particle-blocking section having a plurality of apertures smaller than said particles and said particle-passing section having at least one aperture larger than said particles, said screen being movable such that when said particle-passing section of said movable screen is aligned with said opening of said support said particles may enter said second chamber and when said particle-passing section of said movable screen member is not aligned with said at least one opening of said support said particles may not enter said second chamber.

17. The kit of claim 1 wherein said container further comprises a screen member disposed across said outlet, said screen member having a plurality of apertures and each of said apertures being smaller than said elements such that said elements may not pass through said outlet.

18. The kit of claim 1 wherein said elements comprise polyacrylonitrile.

19. The kit of claim 18 wherein said elements comprise spherical particles.

20. The kit of claim 19 wherein said particles have an outer diameter in the range of 40 μ

m to 2 mm.

21. The kit of claim 1 further comprising a liquid in said container and wherein said elements are hydrated.

22. The kit of claim 1 further comprising at least one cap covering one of said fluid inlet port and fluid outlet port.

23. The kit of claim 1 further comprising a Luer fitting for connecting said fluid source to said fluid inlet port.

24. The kit of claim 1 further comprising a Luer fitting for connecting said outlet port with a delivery catheter.

25. The kit of claim 1 wherein said container further comprises at least one fluid relief port and at least one fluid relief passageway connected to said fluid relief port wherein said at least one fluid relief port has a diameter less than the diameter of said elements and wherein liquid driven through said container flows through said chamber and said fluid relief passageway while said elements flow only through said chamber to said fluid outlet port.

26. A kit comprising:

at least one hydratable vaso-occluding filament; and

a container hold adapted to hold the filament and having an inlet and an outlet wherein at least one of the inlet and outlet is adapted for connection to a fluid source.

27. The kit of claim 26 wherein the inlet is adapted to receive a fluid source and the outlet is adapted for connection to a delivery catheter.

28. The kit of claim 27 wherein said fluid source is a syringe.

29. The kit of claim 26 wherein said filament comprises polyacrylonitrile.

30. The kit of claim 26 wherein said container comprises a passageway having a cross-sectional geometry which allows only one filament of occluding material to pass through at a time.

31. The kit of claim 30 wherein said filament has a diameter in the range of 100 μ

m to 5 mm.

32. The kit of claim 30 wherein said passageway is at least partly straight.

33. The kit of claim 30 wherein said passageway is at least partly curved.

34. The kit of claim 33 wherein said passageway is spiral or helical over at least a portion of its length.

35. The kit of claim 26 wherein said container has a shape selected from the group consisting of disk-, card-, cylindrical-, and turnip-shape.

36. The kit of claim 26 wherein said container further comprises a membrane, said membrane having openings sized to prevent said filament material from passing therethrough but allowing liquid to pass therethrough.

37. The kit of claim 26 wherein the container comprises a rotatable barrel having multiple passageways for holding filaments, and a body having a single ejection channel wherein when one of the multiple passageways is aligned with said single channel a fluid pathway is formed connecting the fluid source to the outlet port of the container.

38. The kit of claim 26 further comprising a displacement member for pushing the filament material out the container.

39. A method for introducing vaso-occluding elements into a delivery catheter comprising:

hydrating the elements in a container, said container having another end adapted for fluid connection with a delivery catheter; and

pushing at least a portion of the material from the container through the catheter and to a target site.

40. The method of claim 39 wherein said pushing comprises attaching a fluid source to an inlet end of the container and applying fluid pressure from the fluid source.

41. The method of claim 39 wherein said elements comprise at least one filament.

42. The method of claim 41 wherein said pushing is performed with an elongated displacement member.

43. The method of claim 41 further comprising the step of severing the filament at a selected location along the length of the filament.

44. The method of claim 43 wherein said severing is performed by pinching the filament at said location between two surfaces.

45. The method of claim 44 wherein said pinching is performed using an expandable balloon.

46. The method of claim 43 wherein said breaking is performed using a noose.

47. The method of claim 41 wherein said filament includes discrete sections having an enlarged diameter.

48. The method of claim 47 further comprising detecting the sections of enlarged diameter and breaking the filament in response to the detecting.

49. The method of claim 43 wherein the breaking is distal to the distal end of the delivery catheter.

50. The method of claim 43 wherein the breaking is performed in the container.

51. The method of claim 39 further comprising purging the container with a therapeutic liquid and using said therapeutic liquid for pushing.

52. A container for holding hydratable vaso-occluding elements, said container comprising:

a delivery tube having an inlet end, a delivery end, a lumen extending from the inlet end to the delivery end, a length from inlet end to delivery end of at least 5 cm and a maximum lumen width along its length in the range from 0.4 mm to 5 mm; and

an inlet coupling disposed on the inlet end of the delivery tube, said inlet coupling being adapted to fluidly couple to a fluid source;

wherein the delivery tube is configured to reduce the length of the container.

53. A container as in claim 52, wherein the inlet coupling is a Luer connector adapted to connect to a syringe.

54. A container as in claim 52, wherein the delivery tube is configured as a helix over at least a portion of its length.

55. A container as in claim 54, wherein the helix is wound over a cylindrical barrel.

56. A container as in claim 54, wherein the helix is wound inside of a cylindrical barrel.

57. A container as in claim 52, wherein the delivery tube is configured as a planar spiral over at least a portion of its length.

58. A container as in claim 57, wherein the planar spiral is formed over a planar card.

59. A container as in claim 52, wherein the delivery tube is configured in a serpentine pattern over at least a portion of its length.

60. A container as in claim 52, further comprising a plurality of hydratable vaso-occluding particles contained in the lumen of the delivery tube.

61. A container as in claim 60, wherein the particles have an average diameter of 75 μ

m to 1.5 mm.

62. A container as in claim 60, wherein the particles are not hydrated.

63. A container as in claim 60, wherein the particles are hydrated in a hydrating medium in the lumen.

64. A container as in claim 52, further comprising at least one hydratable vaso-occluding filament contained in the lumen of the delivery tube.

65. A container as in claim 64, wherein the filament has a length in the range from 1 cm to 2000 cm and a width in the range from 75 μ

m to 5 mm.

66. A container as in claim 65, wherein the filament is not hydrated.

67. A container as in claim 65, wherein the filament is hydrated in a hydrating fluid in the lumen.

68. A container as in claim 52, wherein the delivery end of the delivery tube is straight over a length of at least 1 cm and adapted to be received in a hub of a delivery catheter.

69. A container as in claim 68, wherein the straight delivery end of the delivery tube is tapered to form a seal with a tapered passage in the hub of the delivery catheter.

70. A container as in claim 68, wherein a spherical seal is formed over the straight delivery end of the delivery tube to form a seal with a tapered passage in the hub of the delivery catheter.

71. A method for introducing vaso-occluding elements into an implanted catheter, said method comprising:

providing said elements in a hydration liquid in a delivery tube having a lumen with a length of at least 2 cm and a maximum width along its length in the range from 0.4 mm to 5 mm;

mating a delivery end of the tube with a hub of the implanted catheter; and

transferring said element(s) in the hydration liquid from the lumen and through the delivery end of the delivery tube into a lumen of the implanted catheter.

72. A method as in claim 71, wherein the delivery tube is configured as a helix over at least a portion of its length.

73. A method as in claim 72, wherein the helix is wound over a cylindrical barrel.

74. A method as in claim 72, wherein the helix is wound inside of a cylindrical barrel.

75. A method as in claim 71, wherein the delivery tube is configured as a planar spiral over at least a portion of its length.

76. A method as in claim 75, wherein the planar spiral is formed over a planar card.

77. A method as in claim 72, wherein the delivery tube is configured in a serpentine pattern over at least a portion of its length.

78. A method as in claim 71, wherein providing comprises drawing said elements from a pool of hydrated elements into the lumen of the delivery tube.

79. A method as in claim 78, wherein the elements comprise a filament and drawing comprises applying a vacuum on an inlet end of the delivery tube to capture an end of the filament and draw the length of the filament into the lumen.

80. A method as in claim 79, further comprising priming the delivery tube lumen with the hydration liquid from a syringe and then using the syringe to apply the vacuum.

81. A method as in claim 79, wherein the filament has a length in the range from 1 cm to 2000 cm and a width along their length in the range from 75 μ

m to 5 mm.

82. A method as in claim 71, wherein the delivery tube is provided as a sterile package with the elements in the lumen.

83. A method as in claim 82, wherein the elements are not hydrated in the sterile package, and providing comprises drawing the hydration liquid into the delivery tube.

84. A method as in claim 83, wherein the elements are present in the hydration liquid in the sterile package.

85. A method as in claim 71, wherein mating comprises forming a seal between the delivery end of the delivery tube and a passage of the catheter hub.

86. A method as in claim 85, wherein mating comprises engaging a tapered region of the delivery end in a tapered passage of the catheter hub to form a seal between the delivery tube lumen and the catheter lumen.

87. A method as in claim 85, wherein mating comprises engaging a plug element on the delivery end in a tapered passage of the catheter hub.

88. A method as in claim 85, wherein mating comprises forming a hemostatic seal over the exterior of the delivery end of the delivery tube and extending to the catheter hub.

89. A method as in claim 71, wherein transferring comprises applying pressure at an inlet end of the delivery tube lumen.

90. A method as in claim 71, wherein transferring comprises passing a push rod through an inlet end of the delivery tube lumen and pushing the elements with the rod.

91. A system for delivering vaso-occluding elements, said system comprising:

at least one hydratable vaso-occluding element having a width when hydrated; and

a delivery tube having an inlet end, a delivery end, and a lumen extending from the inlet end to the delivery end;

wherein the lumen of the delivery tube is adapted to hold said hydratable vaso-occluding element and has a width along its length which is at least as large as the width of the vaso-occluding element and less than twice the width of the vaso-occluding element.

92. A system as in claim 91, wherein the hydratable vaso-occluding element comprises at least one filament.

93. A system as in claim 91, wherein the hydratable vaso-occluding element comprises a plurality of particles.

94. A method for delivering hydratable vaso-occluding elements to a target body location, said method comprising singly dispensing one or more vaso-occluding elements through a delivery tube to a catheter lumen, wherein the lumen of the delivery tube is adapted to pass only a single vaso-occluding element at a time.

95. A method as in claim 94, wherein the vaso-occluding elements are dispensed with a hydrating fluid into the catheter lumen.

96. A method as in claim 95, wherein the hydratable vaso-occluding elements are filaments.

97. A method as in claim 95, wherein the hydratable vaso-occluding elements are particles.