Containers and methods for delivering vaso-occluding filaments and particles

• US 20030181931A1
• Filed: 03/25/2002
• Published: 09/25/2003
• Est. Priority Date: 03/25/2002
• Status: Active Grant

• Current Assignee: Stryker Corporation
• Original Assignee: Concentric Medical, Inc. (Stryker Corporation)
• Inventors: Miller, John, Dieck, Martin S., Pierce, Ryan K., Helkowski, Richard A.
• Granted Patent: US 6,953,465 B2
• Time in Patent Office: Days
• US Class Current: 606/157
• 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

This is directed to containers and methods for holding and delivering vaso-occluding materials such as hydrogel particles and filaments. The vaso-occlusive materials may be held in the container in a hydrated or unhydrated state. The container includes a fluid ingress port and a fluid egress port that are respectively fluidly connectable with a fluid source and a delivery catheter. 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. Methods for holding and introducing the materials are also provided.

Claims

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

a.) a plurality of hydratable vaso-occluding particles; and

b.) a container holding the hydratable vaso-occluding particles, said container having an ingress port and an egress port and at least one of the fluid ingress and egress ports adapted for fluid connection with a fluid source.

2. The kit of claim 1 wherein the container comprises a chamber to hold said particles and said chamber has a varying cross sectional area.

3. The kit of claim 2 wherein said varying cross sectional area decreases from the ingress port to the egress port.

4. The kit of claim 2 wherein said chamber has a first section and a second section 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 towards the fluid egress 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 one particle 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 further comprising 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 egress 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 ingress port and fluid egress port wherein when said one-way valve is disposed at said fluid ingress port the valve permits flow only into said container and when said valve is positioned at said fluid egress port said valve permits flow only out of said container.

16. The kit of claim 1 wherein said container further comprises first chamber in fluid communication with said ingress port and a second chamber in fluid communication with said egress 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 fluid outlet and a screen member disposed across said outlet, said screen member having a plurality of apertures and each of said apertures being smaller than said particles such that said particles may not pass through said outlet.

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

19. The kit of claim 18 wherein said particles are spherical.

20. The kit of claim 19 wherein said particles have an outer diameter in the range of 40 um to 2 mm.

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

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

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

24. The kit of claim 1 further comprising a Luer fitting for connecting said egress 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 particles and wherein liquid driven through said container flows through said chamber and said fluid relief passageway while said particles flow only through said chamber to said fluid egress port.

52. The kit of claim 1 wherein said ingress port is configured for receiving liquid to hydrate said vaso-occluding particles and said egress port is configured for said liquid and vaso-occluding particles to exit.

26. A kit comprising:

a.) a hydratable filamentary occluding material; and

b.) a container holding the filamentary occluding material and having a first opening and a second opening wherein at least one of the openings is adapted for connection to a fluid source.

27. The kit of claim 26 wherein the first opening is adapted to receive a fluid source and the second opening is adapted for connection with a delivery catheter.

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

29. The kit of claim 26 wherein said occluding material comprises polyacrylonitrile.

30. The kit of claim 26 wherein said container comprises a passageway and said passageway is adapted to allow 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 microns to 5 mm.

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

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

34. The kit of claim 33 wherein said passageway is spiral or helical shaped.

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 egress port of the container.

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

53. The kit of claim 26 wherein said first opening is configured for receiving fluid and said second opening is configured for fluid flow and exit of the filamentary occluding material.

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

hydrating the material in a container, said container having a distal 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 is performed using fluid pressure.

41. The method of claim 39 wherein said material is 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 breaking the filament at a selected location along the length of the filament.

44. The method of claim 43 wherein said breaking 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.