Embolus Blood Clot Filter Utilizable With A Single Delivery System Or A Single Retrieval System In One of A Femoral or Jugular Access

• US 20100030254A1
• Filed: 06/04/2007
• Published: 02/04/2010
• Est. Priority Date: 06/05/2006
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Ta, Khoi, Chanduszko, Andrzej J.
• Granted Patent: US 9,326,842 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0058 X-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00047 Aluminium or Al-based alloys
• CPC Class Codes: A61F 2310/00071 Nickel or Ni-based alloys
• CPC Class Codes: A61F 2310/00077 Copper or Cu-based alloys
• CPC Class Codes: A61F 2310/00083 Zinc or Zn-based alloys
• CPC Class Codes: A61F 2310/00149 Platinum or Pt-based alloys
• CPC Class Codes: A61F 2310/00155 Gold or Au-based alloys
• CPC Class Codes: A61F 2310/00287 containing titanium carbide

Abstract

A blood filter delivery system for delivering a filter into a vein from either a femoral or jugular access. The preferred system includes an introducer and a push-rod with a spline member disposed along the push-rod and a pusher member disposed on a distal end. The spline member has a main body, first and second boss portions spaced apart along the longitudinal axis to provide a gap for retaining anchor members of the filter during delivery via the introducer. In an alternative embodiment, a preferred filter includes first and second filter structures diverging in opposite directions. A link is connected to portions of each of the first and second filter structures so that each filter structure can be independently collapsed into a generally cylindrical shape.

Claims

1. A blood filter comprising:

first and second filter structures that diverge away from a longitudinal axis in opposite directions in a first configuration of the filter structures; and

a link connected to discrete portions of each of the first and second filter structures so that each filter structure is independently collapsed into a generally cylindrical shape in a second configuration.

2. The blood filter of claim 1, wherein each of the first and second filter structures comprises at least two elongated members.

3. The blood filter of claim 2, wherein each of the at least two elongated members comprises a single wire having a first section defining a portion of the first filter structure, a middle section disposed proximate the longitudinal axis, and a second section defining a portion of the second filter structure.

4. The blood filter of claim 3, where the link comprises an elongated member connected to the first section of each wire of the first filter structure.

5. The blood filter of claim 3, wherein the link comprises an elongated member connected to the first section of each wire of the second filter structure.

6. The blood filter of claim 3, wherein each of the elongated members comprises a tubular member having an open end distal to the longitudinal axis and a hook having a portion disposed in the open end and connected to the link so that the hook is partially retracted into the open end when the link is moved axially along the longitudinal axis.

7. The blood filter of claim 3, wherein the elongated member includes an end configured to slide on the outer surface of the wire.

8. The blood filter of claim 3, wherein the elongated member includes an end fixed for rotation about the wire.

9. The blood filter of claim 3, wherein the elongated member includes an end configured to slide and rotate with respect to the wire.

10. The blood filter of claim 9, further comprising a boss connected to the link member.

11. The blood filter of claim 9, further comprising a hub disposed about the middle portion of each wire.

12. The blood filter of claim 11, wherein the first filter structure comprises a retention member disposed at one terminal end of each wire.

13. The blood filter of claim 12, wherein the retention member comprises an anchor.

14. The blood filter of claim 13, wherein the anchor comprises a hook having a material selected from a group consisting essentially of shape memory material, super-elastic material, linear-elastic material, metal, alloys, polymers and combinations thereof.

15. The blood filter of claim 14, wherein the wire comprises a material selected from a group consisting essentially of shape memory material, super-elastic material, linear-elastic material, metal, alloys, polymers and combinations thereof.

16. The blood filter of claim 14, wherein the hook comprises a curved configuration in an operative condition and a generally linear configuration in another condition.

19. The blood filter of claim 4, wherein the link comprises an elongate member unitary with a coupling.

20. The blood filter of claim 19, wherein the coupling comprises a super elastic hinge.

17. (canceled)

18. (canceled)

21. A delivery catheter sheath for a blood filter comprising:

a generally tubular member having a first end, intermediate end and a second end defining a longitudinal axis extending therethrough, the first end having an inner surface exposed to the longitudinal axis, the inner surface having a plurality of notches formed on the inner surface, the intermediate end including a boss portion disposed in the tubular member having a plurality of grooves formed in the boss portion.

22. The delivery catheter sheath of claim 21, further comprising a body coupled at one end to the second end of the sheath and an elongated member coupled to the boss portion, the elongated member extending out of another end of the body to provide a handle.

23. The delivery catheter sheath of claim 22, wherein the body comprises a Y-adapter.

24. The delivery catheter sheath of claim 22, further comprising marker disposed proximate the first end of the sheath.

25. The delivery catheter sheath of claim 24, wherein the elongated member comprises a generally cylindrical member having at least two different cross-sectional areas proximate the handle.

26. The delivery catheter sheath of claim 25, wherein the body comprises a snap-fit boss formed on an outer surface of the Y-adapter proximate the second end of the catheter sheath.

27. The delivery catheter sheath of claim 22, wherein the sheath comprises a polymeric tube having at least two different Shore durometer of hardness proximate one of the first and second ends.

28. The delivery catheter sheath of claim 22, wherein each groove of the plurality of grooves comprises a plurality of widths along a length of the groove.

29. The delivery catheter sheath of claim 22, further comprising at least one anchor portion of a filter located in at least one of the plurality of grooves, the anchor portion having a maximum width greater than a minimum width of the groove.

30. A blood filter retrieval device comprising:

a first generally tubular member that extends from a first end to a second end to define a longitudinal axis extending therethrough;

a second generally tubular member disposed generally coaxially with the first generally tubular member;

a collapsible member coupled to the second generally tubular member that defines a portion of a cone in one configuration and a general cylindrical shape in another configuration; and

a retrieval member disposed in the second tubular member and the collapsible member.

31. The retrieval device of claim 30, further comprising a third generally tubular member disposed about a portion of the retrieval member.

32. The retrieval device of claim 30, wherein the retrieval member comprises a plurality of claws.

33. The retrieval device of claim 30, wherein the retrieval member comprises an elongated member coupled to at least one claw.

34. The retrieval device of claim 33, wherein the collapsible member comprises a plurality of radially extending member connected together via a membrane to define a generally truncated cone.

35. The retrieval device of claim 34, wherein the membrane comprises a material selected from a group consisting essentially of polyurethane, polytetrafluoroethylene, nylon, PET, PEBAK, barium sulfate, and combinations thereof.

36. The retrieval device of claim 34, further comprising a radiopaque marker disposed on at least one of the first, second and third tubular members.

37. A blood filter system comprising:

an introducer having a coupling port connected to an elongated generally tubular member;

a pusher assembly having a first end disposed in the storage member and a second end extending out of the Y-adapter, the pusher assembly including;

a handle disposed along a longitudinal axis of the pusher assembly proximate the second end;

a pusher disposed along the longitudinal axis proximate the first end of the elongated assembly; and

a generally tubular member having a first end, intermediate end and a second end defining a longitudinal axis extending therethrough, the first end having an inner surface exposed to the longitudinal axis, the inner surface having a plurality of notches formed on the inner surface, the intermediate end including a boss portion coupled to the pusher and disposed in the tubular member having a plurality of grooves formed in the boss portion, the first end coupled to the Y-adapter; and

a blood filter including;

at least a first anchor member having hooks disposed in one of the grooves and notches; and

at least a second anchor member having hooks disposed in the other of the grooves and notches.

38. The system of claim 37, wherein each groove of the plurality of grooves comprises a plurality of widths along a length of the groove.

39. The system of claim 38, wherein the hook comprises a maximum width greater than a minimum width of the groove.

40. A blood filter kit comprising:

a delivery system including;

an introducer having a coupling port connected to an elongated generally tubular member;

a dilator configured to be inserted into the introducer to dilate a vessel;

a pusher assembly having a first end disposed in the storage member and a second end extending out of the Y-adapter, the pusher assembly including;

a handle disposed along a longitudinal axis of the pusher assembly proximate the second end;

a pusher member disposed along the longitudinal axis proximate the first end of the elongated assembly; and

a generally tubular member having a first end, intermediate end and a second end defining a longitudinal axis extending therethrough, the first end having an inner surface exposed to the longitudinal axis, the inner surface having a plurality of notches formed on the inner surface, the intermediate end including a boss portion coupled to the pusher and disposed in the tubular member having a plurality of grooves formed in the boss portion, the first end coupled to the Y-adapter;

a blood filter including;

at least a first anchor member having hooks disposed in one of the grooves and notches;

at least a second anchor member having hooks disposed in the other of the grooves and notches; and

a human readable graphical and textual instruction on how to deliver the blood filter to a site in format using the delivery device.

41. The kit of claim 40, further comprising a retrieval device including:

a first generally tubular member that extends from a first end to a second end to define a longitudinal axis extending therethrough;

a second generally tubular member disposed generally coaxially with the first generally tubular member;

a collapsible member coupled to the second generally tubular member that defines a portion of a cone in one configuration and a cylinder in another configuration;

a retrieval member disposed in the second tubular member and the collapsible member; and

a human readable graphical and textual instruction on how to retrieve the blood filter.

42. A method of delivering a blood filter from either an incision in the femoral or jugular vessels, the method comprising:

providing a filter having first and second filter structures that diverge away from a longitudinal axis in opposite directions in a first configuration and a link connected to discrete portions of each of the first and second filter structures so that each filter structure is independently collapsed into a generally cylindrical shape in a second configuration;

storing the filter proximate a distal end of a generally tubular sheath having a first end, intermediate end and a second end defining a longitudinal axis extending therethrough, the first end having an inner surface exposed to the longitudinal axis, the inner surface having a plurality of notches formed on the inner surface, the intermediate end including a boss portion coupled to the pusher and disposed in the tubular member having a plurality of grooves formed in the boss portion;

accessing an implantation site via one of the femoral or jugular vessels; and

releasing the filter from the sheath proximate the implantation site to engage the filter structures against a vessel wall of the implantation site.

43. The method of claim 42, further comprising retrieval of the blood filter by:

forming an access to the implantation site via one of the femoral or jugular vessels; and

retrieving the filter into a retrieval sheath.

44. The method of claim 43, wherein the retrieving comprises retracting a portion of at least one hook from one of the filter structures to disengage the hook from the vessel wall.