Embolus blood clot filter and delivery system

• US 8,062,327 B2
• Filed: 05/09/2006
• Issued: 11/22/2011
• Est. Priority Date: 08/09/2005
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Graves, David M., Chanduszko, Andrzej J.
• Primary Examiner(s): Houston; Elizabeth
• Application Number:
  US11/997,832
• Publication Number:
  US 20090131970A1
• Time in Patent Office: 2,023 Days
• Field of Search: 606/108, 606/191, 606/194, 606/198, 606/200, 604104-107, 604/164.01, 604/164.1, 604/164.11, 604/165.01, 604/165.02, 623901-903, 128/830, 128/831, 128/833, 128/840
• US Class Current: 606/200
• CPC Class Codes: A61F 2/0103 With centering means
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure

Abstract

A blood filter delivery system for delivering a filter into a vein includes an introducer and a push rod with a spline member disposed along the push rod. 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 member of the filter during delivery via the introducer.

Claims

1. A blood filter delivery system for a blood filter unit, comprising:

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

a storage member coupled to the coupling port of the introducer and a Y-adaptor; and

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

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

a pusher pad disposed along the longitudinal axis of the pusher assembly proximate the distal end;

an elongated member between the handle and the pusher pad, the elongated member having a flexible section with a distal end directly in contact with and continuous with a proximal end of the pusher pad, the flexible section compressed along the longitudinal axis in a predeployed configuration to provide a spring force for filter deployment; and

a spline member disposed on the pusher assembly along the longitudinal axis between the handle and the pusher, the spline member having a first boss portion and a second boss portion spaced apart along the longitudinal axis to provide a gap therebetween, the first boss portion including a plurality of longitudinal grooves; and

a blood filter having a plurality of anchor members disposed about the longitudinal axis, each of the anchor members having;

a portion disposed in each of the plurality of longitudinal grooves, respectively; and

a hook disposed in the gap.

2. The blood filter delivery system according to claim 1, wherein the elongated generally tubular member of the introducer further comprises a radio-opaque marker disposed on the elongated generally tubular member distally with respect to the coupling port.

3. The blood filter delivery system according to claim 2, wherein the coupling port comprises a port body having an opening, the opening including a seal occluding the opening, the port body having an edge disposed about the opening that is securable to a projection formed on one end of the storage member via a sudden sharp engagement.

4. The blood filter delivery system according to claim 3, wherein the projection of the storage member comprises a curved surface disposed circumferentially about the longitudinal axis.

5. The blood filter delivery system according to claim 3, wherein the elongated member comprises a metallic wire having a plurality of differing cross-sections at various locations along the length of the elongated member.

6. The blood filter delivery system according to claim 5, wherein the metallic wire comprises a stainless steel member having a first cross-sectional area connected to a shape memory alloy wire having a second cross-sectional area less than the first cross-sectional area.

7. The blood filter delivery system according to claim 1, wherein the pusher pad comprises a generally cylindrical pusher member disposed proximate the distal end of the elongated assembly, the generally cylindrical pusher member being spaced from a nearest portion of the spline member at a distance of about 34 millimeters.

8. The blood filter delivery system according to claim 7, wherein the first boss portion of the spline member comprises a plurality of longitudinal projections spaced apart from each other and disposed about a generally cylindrical main surface to define the plurality of longitudinal grooves.

9. The blood filter delivery system according to claim 8, wherein the second boss portion of the spline member comprises a generally cylindrical member disposed about the generally cylindrical main surface, the generally cylindrical member having a generally planar surface disposed about the generally cylindrical surface and spaced apart from a nearest portion of the first boss portion at a distance of about 1.3 millimeters along the longitudinal axis.

10. The blood filter delivery system according to claim 1, further comprising a dilator assembly having a dilator hub coupled to an elongated hollow member having a first end proximate the dilator hub and a second end distal to the first end, the second end having a first radio-opaque marker disposed about 28 millimeters from the second end.

11. The blood filter delivery system according to claim 10, wherein the second end comprises a second radio-opaque marker disposed about 28 millimeters from the first radio-opaque marker.

12. The blood filter delivery system according to claim 11, wherein the elongated hollow member comprises a passageway and plurality of fluid ports extending through a wall of the hollow member to the passageway, the plurality of fluid ports being spaced apart from each other in a spiral configuration on the elongated hollow member between the first and second radio-opaque markers.

13. The blood filter delivery system according to claim 1, wherein the filter comprises:

a body extending along a longitudinal axis from a first end to a second end, the body having a snareable tip disposed thereon;

the plurality of anchor members, in an unconstrained configuration of the filter, extending obliquely from the second end of the body away from the longitudinal axis, the plurality of anchor members having a length along the longitudinal axis and defining a maximum width between any two anchor members of at least 0.9 times the length so that each hook connected to each anchor member penetrates a wall of the blood vessel when the filter is placed into the blood vessel;

a plurality of locators, in an unconstrained configuration of the filter, extending obliquely from the second end of the body away from the longitudinal axis so that a portion of each locator engages the wall.

14. The blood filter delivery system according to claim 1, further comprising a bio-active agent.

15. A pusher assembly for use in a vena cava filter delivery unit, the pusher assembly including a filter having a plurality of filter anchor members with a plurality of hooks, the assembly comprising:

an elongated member extending along a longitudinal axis from a proximal end to a distal end, the elongated member having a plurality of cross-sections at various locations along the elongated member, a flexible reduced cross-section disposed at the second end and compressed in a pre-deployed configuration along the longitudinal axis to provide a spring force for filter deployment;

a handle disposed proximate the proximal end of the elongated member;

a pusher pad disposed proximate the distal end of the elongated member, the pusher pad having a proximal end directly in contact with and continuous with a distal end of the flexible reduced cross-section; and

a spline member disposed along the longitudinal axis between the handle and the pusher pad, the member having a first boss portion and a second boss portion spaced apart along the longitudinal axis to provide a gap therebetween, the first boss portion including a plurality of longitudinal grooves, wherein each of the grooves accommodates a respective portion of each of the filter anchor members, and wherein the gap accommodates the plurality of hooks.

16. The pusher assembly according to claim 15, wherein the gap comprises an annular gap.

17. The pusher assembly according to claim 15, wherein the elongated member comprises a metallic wire having a plurality of cross-sections at various locations along the length of the elongated member.

18. The pusher assembly according to claim 17, wherein the metallic wire comprises a stainless steel member having a first cross-sectional area connected to a shape memory alloy wire having a second cross-sectional area less than the first cross-sectional area.

19. The pusher assembly according to claim 18, wherein the pusher pad comprises a generally cylindrical pusher member disposed proximate the distal end of the elongated assembly, the generally cylindrical pusher member being spaced from a nearest portion of the spline member at a distance of about 34 millimeters.

20. The pusher assembly according to claim 19, wherein the first boss portion of the member comprises a plurality of longitudinal projections spaced apart from each other and disposed about a generally cylindrical main surface to define the plurality of longitudinal grooves.

21. The pusher assembly according to claim 20, wherein the second boss portion of the member comprises a generally cylindrical member disposed about the generally cylindrical main surface, the generally cylindrical member having a generally planar surface disposed about the generally cylindrical surface and spaced apart from a nearest portion of the first boss portion at a distance of about 1.3 millimeters along the longitudinal axis.

22. The pusher assembly according to claim 15, further comprising a bio-active agent coupled to the pusher assembly proximate the distal end.

23. A pusher assembly for use in a vena cava filter delivery unit, the pusher assembly comprising:

an elongated member extending along a longitudinal axis from a first end to a second end;

a handle disposed proximate the first end;

a pusher disposed proximate the second end;

a spline member disposed along the longitudinal axis between the handle and the pusher, the spline member having a plurality of grooves, each groove defining a plurality of widths along a length thereof; and

a filter having a plurality of anchor members terminating in a hook, each anchor member having an anchor portion adjacent to the hook located, respectively, in one of the plurality of grooves, the anchor member having a maximum width greater than a minimum width of the groove, the hook having an end located outside of the groove.

24. The pusher assembly according to claim 23, wherein the plurality of grooves are located in a first conical surface of the spline member.

25. The pusher assembly according to claim 24, wherein each hook is positioned over a second conical surface of the spline member.

26. The pusher assembly according to claim 23, wherein the anchor portion has a frustoconical shape including a first diameter and a second diameter smaller than the first diameter, wherein the first diameter is equivalent to the maximum width of the anchor member.

27. A method of packaging a blood filter having a plurality of anchors about a longitudinal axis, each of the anchors having a hook and at least two of the anchors defining a span intersecting the longitudinal axis and between the at least two anchors of about 40 millimeters, the anchors being coupled to a hub that extends along the longitudinal axis, the method comprising:

positioning a pusher pad connected to a flexible section of an elongate member against the hub;

locating a curved portion of each hook in an annular gap disposed between two boss portions of a support assembly, wherein the support assembly includes a plurality of grooves that extends through one of the two boss portions;

locating a portion of each anchor in each of the longitudinal grooves respectively, such that the flexible section is compressed along the longitudinal axis to provide a spring force for filter deployment; and

enclosing the filter, including the plurality of hooks and the boss portions, in a generally tubular member having an outside diameter of less than about 10 French (about 3.3 millimeters in diameter).

28. The method according to claim 27, wherein the locating the curved portion of each hook comprises providing a hook having a cross sectional area along the arcuate portion of the hook greater than 0.04 millimeters squared.

29. The method according to claim 27, wherein the outside diameter is about 9 French (about 2.9 millimeters in diameter).

30. The method according to claim 27, wherein an inside diameter of the generally tubular member is about 7 French (about 2.3 millimeters diameter).

31. The method according to claim 27, wherein the enclosing comprises preventing movement of the filter relative to the generally tubular member along the longitudinal axis upon application of axial force of less than 5 Pound-force in a proximal direction.

32. The method according to claim 27, wherein the enclosing comprises preventing movement of the filter relative to the generally tubular member along the longitudinal axis upon application of axial force of less than 10 Pound-force in a proximal direction.

33. The method according to claim 27, wherein the locating comprises preloading the hub of filter in a distal direction towards an opening of the generally tubular member with the anchors extending in a proximal direction away from the hub.