Embolic protection system

• US 6,887,256 B2
• Filed: 04/20/2001
• Issued: 05/03/2005
• Est. Priority Date: 11/07/1997
• Status: Expired due to Term

• Current Assignee: Salvic Limited
• Original Assignee: Salviac Ltd. (Abbott Laboratories Incorporated)
• Inventors: Taylor, Charles, Gilson, Paul, Brady, Eamon, Vale, David, Gilvarry, Michael, Griffin, Patrick
• Primary Examiner(s): NERBUN, PETER P
• Application Number:
  US09/838,544
• Publication Number:
  US 20020052626A1
• Time in Patent Office: 1,474 Days
• Field of Search: 606/200, 606/191, 606/194, 606/198, 606/127, 606/108, 606/114, 606/159, 604/96.01, 604/104, 604/105, 604/106
• US Class Current: 606/200
• 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 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/015 Stop means therefor
• 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 2230/0067 conical

Abstract

An assembly for loading a collapsible embolic protection filter 1 into a catheter 2, comprises a catheter 2 defining a reception space at a distal end of the catheter 2 for receiving a collapsed embolic protection filter 1; and a separate removable pushing device 8 for delivering the embolic protection filter 1 into the reception space. The pushing device 8 comprises an elongate stem 71 with a proximal stop 72 for engagement with the filter 1. A separate loading device 7 to collapse the embolic protection filter 1 is also provided. The loading device 7 defines an inlet end and an outlet end, the outlet end being configured for co-operative alignment with the reception space.

Claims

1. A method of loading an embolic protection filter into a catheter, the method comprising the steps of:

providing an embolic protection filter, the embolic protection filter being collapsible;

providing a catheter defining a reception space at a distal end of the catheter for receiving the collapsed embolic protection filter, the catheter comprising an internal proximal stop;

providing a loading device to collapse the embolic protection filter, the loading device defining an inlet end and an outlet end;

aligning the outlet end of the loading device with the reception space;

delivering the embolic protection filter through the loading device and into the reception space;

moving the collapsed embolic protection filter towards the reception space to engage said internal proximal stop; and

disassociating the loaded catheter from the loading device.

2. A method as claimed in claim 1 wherein the method further comprises the steps of:

providing an urging device for delivering the embolic protection filter through the loading device and into the reception space; and

for engaging the collapsed embolic protection filter with the internal proximal stop; and

removing the urging device after disassociating the loaded catheter from the loading device.

3. A method as claimed in claim 2 wherein the urging device comprises a wire for threading through the embolic protection filter, and a stop for engaging the embolic protection filter.

4. A method as claimed in claim 1 wherein the loading device comprises an elongate neck at the outlet end, and the method comprises the step of at least partially aligning the elongate neck with the reception space before delivering the embolic protection filter through the loading device.

5. A method as claimed in claim 1 wherein the method comprises the step of flushing the embolic protection filter before delivering the embolic protection filter through the loading device.

6. A method as claimed in claim 1 wherein the method comprises the step of flushing the catheter before delivering the embolic protection filter into the reception space.

7. A method as claimed in claim 1 wherein the catheter comprises an outer catheter tube and an inner catheter tube, the inner catheter tube defining the internal proximal stop.

8. A method as claimed in claim 7 wherein both the inner catheter tube and the outer catheter tube are flushed before delivering the embolic protection filter through the loading device.

63. A method as claimed in claim 1 wherein further moving of the collapsed embolic protection filter proximally after engaging the internal proximal stop causes said disassociation of the loaded catheter from the loading device.

9. A vascular filter assembly and assembly for loading the vascular filter assembly comprising:

a vascular filter assembly for removing embolic material in body fluid flowing within a vessel, the vascular filter assembly having an expanded state and a pre-deployment collapsed state and comprising;

a filter element, the filter element comprising a filter membrane and a filter support frame for the membrane;

the filter support frame being collapsed in the pre-deployment state and the filter support frame being expanded in the expanded state;

the filter element having at least one inlet opening at a proximal end of the filter element and a plurality of outlet openings towards a distal end of the filter element, the outlet openings allowing body fluid to flow through the filter element but retaining embolic material within the filter element, and the inlet opening being larger than any of the outlet openings;

a lumen extending through the filter element from the proximal end of the filter element to the distal end of the filter element; and

an abutment coupled to the filter element;

a delivery catheter, the delivery catheter including a reception space at a distal end of the delivery catheter for receiving the filter assembly in the pre-deployment collapsed state; and

an urging device delivering the filter assembly into the reception space of the delivery catheter, the urging device being engagable with the abutment in the expanded state of the filter assembly to assist in collapsing the filter assembly from the expanded state to the collapsed pre-deployment state.

10. The assemblies as claimed in claim 9 comprising a separate loading device to collapse the filter assembly, the loading device defining an inlet end and an outlet end, the outlet end being configured for co-operative alignment with the reception space.

11. The assemblies as claimed in claim 9 wherein the urging device comprises a stop for engagement with the filter assembly.

12. The assemblies as claimed in claim 9 wherein the urging device comprises a stem, the stem having a stop for engaging the abutment of the filter assembly.

13. The assemblies as claimed in claim 9 wherein the urging device comprises a handle.

14. The assemblies as claimed in claim 9 wherein the loading device is configured to radially compress the filter assembly.

15. The assemblies as claimed in claim 14 wherein the loading device comprises a funnel, the inlet end defining a larger cross sectional area than the outlet end.

16. The assemblies as claimed in claim 15 wherein the loading device comprises a main support having a funnel-shaped bore formed from a frusto-conical filter assembly receiving portion and a cylindrical portion formed by a loading tube projecting from the main support, the cylindrical portion being aligned with the reception space before loading.

17. The assemblies as claimed in claim 15 in which the cone angle of the funnel is between 15°

and 65°

.

18. The assemblies as claimed in claim 17 in which the cone angle is between 35°

and 45°

.

19. The assemblies as claimed in claim 10 wherein the loading device extends into the reception space.

20. The assemblies as claimed in claim 10 wherein the loading device extends around the outside of the reception space.

21. The assemblies as claimed in claim 9 comprising a tray, the tray comprising a first retainer configured to releasably support the urging device in a disengaged position before delivering the filter assembly into the delivery catheter.

22. The assemblies as claimed in claim 21 comprising a second retainer configured to releasably support the loading device in co-operative alignment with the delivery catheter during loading.

23. The assemblies as claimed in claim 21 wherein the first and second retainers together include a channel for receiving at least one of the loading device and the delivery catheter and the urging device, and at least one projection on the channel wall projecting inwardly for snap retention of at least one of the loading device and the delivery catheter and the urging device.

24. The assemblies as claimed in claim 21 wherein the tray comprises a liquid retaining bath formed by a recess in the tray, the bath having a depth sufficient to accommodate in a totally submerged state the reception space of the delivery catheter and the filter assembly for submerged loading of the filter assembly into the reception space.

25. The assemblies as claimed in claim 24 wherein the tray has a catheter holding channel communicating with the bath, the channel defining a pathway around the tray which supports the delivery catheter in a loading position on the tray.

26. The assemblies as claimed in claim 25 wherein the delivery catheter is secured within the channel with a number of retainers spaced-apart along the channel, each retainer comprising two or more associated projections which project inwardly from opposite side walls of the channel adjacent a mouth of the channel, the projections being resiliently deformable for snap engagement of the delivery catheter within the channel behind the projections.

27. The assemblies as claimed in claim 25 wherein a ramp is provided at an end of the holding channel communicating with the bath to direct the reception space of the delivery catheter towards a bottom of the bath.

28. The assemblies as claimed in claim 27 wherein a support is provided within the bath for supporting the reception space of the delivery catheter above the bottom of the bath.

29. The assemblies as claimed in claim 28 wherein said support is a step adjacent the channel.

30. The assemblies as claimed in claim 24 wherein the first retainer is provided within the bath.

31. The assemblies as claimed in claim 9 comprising a flushing device.

32. The assemblies as claimed in claim 31 wherein the flushing device comprises a syringe.

33. The assemblies as claimed in claim 9 wherein the lumen extends along a central axis of the filter element.

34. The assemblies as claimed in claim 9 wherein the lumen is formed at least in part by a tubular member coupled to the filter element.

35. The assemblies as claimed in claim 34 wherein the filter element is fixed to proximal end portion of the tubular member and detached from a distal end portion of the tubular member.

36. The assemblies as claimed in claim 34 wherein the tubular member extends substantially the entire length of the filter element.

37. The assemblies as claimed in claim 34 wherein the abutment is formed by a distal end portion of the tubular member.

38. The assemblies as claimed in claim 34 wherein the abutment is attached to the tubular member.

39. The assemblies as claimed in claim 34 wherein the abutment is located proximal of a distal end portion of the tubular member.

40. The assemblies as claimed in claim 9 wherein the urging device is a pushing device having a proximal end located distal of the filter assembly, the pushing device configured to provide a pushing force on the filter assembly to assist in collapsing the filter assembly.

41. The assemblies as claimed in claim 9 wherein the urging device is a pulling device having a proximal end located proximal of the filter assembly, the pulling device configured to provide a pulling force on the filter assembly to assist in collapsing the filter assembly.

42. The assemblies as claimed in claim 9 wherein a portion of the urging device extends through the lumen when collapsing the filter assembly from the expanded state to the collapsed pre-deployment state.

43. A method for loading an vascular filter assembly into a delivery catheter prior to deploying the filter assembly in a patient, the method comprising the steps of:

providing a vascular filter assembly having an expanded state and a pre-deployment collapsed state, the filter assembly comprising;

a filter element, the filter element comprising a filter membrane and a filter support frame for the membrane;

the filter support frame being collapsed in the pre-deployment state and the filter support frame being expanded in the expanded state;

the filter element having at least one inlet opening at a proximal end of the filter element and a plurality of outlet openings towards a distal end of the filter element, the outlet openings allowing body fluid to flow through the filter element but retaining embolic material within the filter element, and the inlet opening being larger than any of the outlet openings;

a lumen extending through the filter element from the proximal end of the filter element to the distal end of the filter element; and

an abutment coupled to the filter element;

providing a delivery catheter, the delivery catheter including a reception space at a distal end thereof;

providing an urging device;

engaging the urging device with the abutment in the expanded state of the filter assembly; and

using the urging device to move the filter assembly towards the pre-deployment collapsed state and deliver the filter assembly into the reception space in the delivery catheter.

44. A method as claimed in claim 43 comprising the steps of:

providing a loading device, the loading device defining an inlet end and an outlet end;

aligning the outlet end of the loading device in co-operation with the reception space; and

delivering the filter assembly through the inlet end of the loading device in the expanded state and into the reception space.

45. A method as claimed in claim 44 wherein the delivery catheter comprises an internal proximal stop, and the method comprises the step of moving the collapsed filter assembly proximally in the reception space using the urging device to engage the internal proximal stop and disassociating the loaded delivery catheter from the loading device before removing the urging device.

46. A method as claimed in claim 45 wherein the delivery catheter is constrained relative to the loading device before delivery of the filter assembly through the loading device into the reception space, and the method comprises the step of releasing the constraint to facilitate disassociation of the loaded delivery catheter from the loading device.

47. A method as claimed in claim 43 wherein the urging device comprises a wire for threading through the filter assembly, and a stop for engaging the abutment of the filter assembly.

48. A method as claimed in the claim 43 wherein the loading device comprises an elongate neck at the outlet end, and the method comprises the step of at least partially positioning the elongate neck in the reception space before delivering the filter assembly into the reception space.

49. A method as claimed in claim 43 wherein the method comprises the step of flushing the filter assembly before delivering the filter assembly into the reception space.

50. A method as claimed in claim 43 wherein the method comprises the step of flushing the delivery catheter before delivering the filter assembly into the reception space.

51. A method as claimed in claim 45 wherein the delivery catheter comprises an outer catheter tube and an inner catheter tube, the inner catheter tube defining the internal proximal stop.

52. A method as claimed in claim 51 wherein both the inner catheter tube and the outer catheter tube are flushed before delivering the filter assembly through the loading device.

53. A method as claimed in claim 43 wherein the lumen extends along a central axis of the filter element.

54. A method as claimed in claim 43 wherein the lumen is formed at least in part by a tubular member coupled to the filter element.

55. A method as claimed in claim 54 wherein the filter element is fixed to proximal end portion of the tubular member and detached from a distal end portion of the tubular member.

56. A method as claimed in claim 54 wherein the tubular member extends substantially the entire length of the filter element.

57. A method as claimed in claim 54 wherein the abutment is formed by a distal end portion of the tubular member.

58. A method as claimed in claim 54 wherein the abutment is attached to the tubular member.

59. A method as claimed in claim 54 wherein the abutment is located proximal of a distal end portion of the tubular member.

60. A method as claimed in claim 43 wherein the step of using the urging device to move the filter assembly includes providing a pushing force on the urging device to provide a pushing force on the filter assembly.

61. A method as claimed in claim 43 wherein the step of using the urging device to move the filter assembly includes providing a pulling force on the urging device to provide a pulling force on the filter assembly.

62. A method as claimed in claim 43 wherein a portion of the urging device extends through the lumen when collapsing the filter assembly.