Embolus blood clot filter delivery system

• US 8,734,479 B2
• Filed: 12/29/2006
• Issued: 05/27/2014
• Est. Priority Date: 12/30/2005
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Kashkarov, Alexander Germanovich, Chanduszko, Andrzej J.
• Primary Examiner(s): Dowe, Katherine
• Assistant Examiner(s): Kapoor, Sidharth
• Application Number:
  US12/096,783
• Publication Number:
  US 20090318951A1
• Time in Patent Office: 2,706 Days
• Field of Search: 606/1, 606191-200, 128898-899, 600/200
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A blood filter delivery system for delivering a blood filter into a vein includes a push rod for pushing the blood filter through and out of a catheter, the push rod having a filter positioning assembly on one end. The filter positioning assembly includes positioner members, which retain anchor members of the filter. The filter positioning assembly can position the end of the delivery catheter near the blood vessel centerline before releasing the filter'"'"'s anchor members, thereby helping to align the blood filter along the centerline of the blood vessel.

Claims

1. A blood filter and delivery apparatus for delivering a blood filter into a blood vessel, the vessel having a wall and a centerline, the apparatus comprising:

a) a blood filter including a plurality of filter members, a proximal filter end, and a distal filter end

b) a catheter having proximal and distal ends, the distal end being a free end portion with an opening, the catheter having a catheter wall with an inner surface surrounding a catheter lumen;

c) a filter positioning assembly situated with the filter within the catheter lumen to define a stored position, the filter positioning assembly including a plurality of positioner members, each of the plurality of positioner members having a distal end that is connected to one or more filter members of the filter within the catheter lumen in said stored position;

d) wherein in said stored position, the filter is positioned closer to the filter opening than the positioning assembly;

e) a pusher that engages the positioning assembly and filter inside the lumen in said stored position, wherein the positioning assembly and filter are movable from said stored position within the catheter lumen, to a preliminary dispensed position, and to a fully deployed position;

f) wherein in said preliminary dispensed position, some of the filter members and some of the positioning members engage the vessel wall while at least a portion of some of the filter members remain inside the catheter lumen; and

g) wherein in said fully deployed position all the filter members of the filter are deployed in the vessel by at least partially retracting the plurality of positioner members with the catheter.

2. The blood filter delivery apparatus of claim 1, further comprising a hub coupled to the plurality of positioner members, said hub defining the filter distal end, the positioner members being in between the hub and the catheter open end in the stored position.

3. The blood filter delivery apparatus of claim 2, wherein the hub includes a radio-opaque material.

4. The blood filter delivery apparatus of claim 2, wherein the hub includes at least one spline configured to retain the plurality of filter members.

5. The blood filter delivery apparatus of claim 2, wherein the hub, spline and plurality of positioner members are formed integrally.

6. The blood filter delivery apparatus of claim 2, wherein the hub has a central hub lumen.

7. The blood filter delivery apparatus of claim 1, wherein in the preliminary dispensed position the plurality of positioner members are configured to extend radially to define a catheter centerline as the filter positioning assembly and a portion of the filter exit an end of the catheter and wherein the plurality of positioner members press against a wall of the blood vessel.

8. The blood filter delivery apparatus of claim 7, wherein the positioner members locate the end of the catheter substantially along the catheter centerline so as to further locate the end of the catheter centrally within the blood vessel.

9. The blood filter delivery apparatus of claim 4, wherein in an installed position the plurality of filter members are unconstrained by the catheter after the end of the catheter is positioned substantially along the centerline.

10. The blood filter delivery apparatus of claim 1, wherein the plurality of positioner members are of a Nitinol material.

11. The blood filter delivery apparatus of claim 1, wherein the filter positioning assembly has a longitudinal axis, and further comprises an extension wire oriented along the longitudinal axis and configured to contact a hub of the filter when the plurality of filter members are retained by the plurality of positioner members.

12. The blood filter delivery apparatus of claim 1, wherein the pusher includes an elongated push rod coupled to the filter positioning assembly.

13. The blood filter delivery apparatus of claim 1, wherein the plurality of positioner members each have a constant cross section over a majority of its length.

14. The blood filter delivery apparatus of claim 1, wherein the plurality of positioner members each have a proximal end and a distal end to define a length therebetween, at least one positioner member having a variable cross section over a majority of the length.

15. The blood filter delivery apparatus of claim 14, wherein the at least one-positioner member has a cross section at the proximal end greater than the cross section at the distal end.

16. The blood filter delivery apparatus of claim 14, wherein the at least one positioner member has a cross section at the proximal end less than the cross section at the distal end.

17. The blood filter delivery apparatus of claim 1, wherein the plurality of positioner members are curved with a constant radius of curvature over a majority of their length.

18. A blood filter and delivery assembly for delivering a blood filter to a blood vessel having a blood vessel wall, comprising:

a) a storage tube having proximal and distal end portions, a tube bore, and a distal open end at said distal end portion;

b) a blood filter having a filter proximal and a filter distal end and positioned within the storage tube bore to provide a storage position wherein the filter distal end is closer than the filter proximal end to the storage tube distal open end, the blood filter including a plurality of filter members having free end portions that are positioned proximally in said storage position;

c) a filter positioning assembly positioned within the storage tube bore in said storage position, the filter positioning assembly including a plurality of positioner members that extend distally and connect to the free end portions of the plurality of filter members in said storage position that places the filter closer to the distal open end and the positioning assembly farther from the distal open end relative to said filter;

d) a pusher that engages and pushes the connected positioner assembly and filter from the lumen toward the vessel via the distal open end into a preliminary dispensed position, and into a fully deployed position;

e) wherein in said preliminary dispensed position, the positioner members engage the vessel wall while at least a portion of some of the filter members appendages remain in the tube bore; and

f) wherein in said fully deployed position all the filter members of the filter are deployed in the vessel by at least partially retracting the plurality of positioner members with the catheter.

19. The blood filter delivery apparatus of claim 18, wherein the pusher includes an elongated push rod coupled to the filter positioning assembly.

20. A push rod assembly for use in delivering a filter into a blood vessel, the vessel having a wall, the assembly comprising:

a) a catheter having a catheter bore and a distal open end;

b) a blood filter having proximal and distal filter ends and a plurality of anchor members having anchor end portions at said proximal filter end;

c) a push rod extending along a longitudinal axis from a first end to a second end;

d) a handle disposed proximate the first end;

e) a filter positioning assembly disposed at the second end, the filter positioning assembly having a longitudinal axis and including;

a hub; and

a plurality of positioner members coupled to the hub, each positioner member having a positioner end extending distally, wherein each of the plurality of positioner members is curved and oriented so that the positioner members extend away from the longitudinal axis when unconstrained, and the positioner members are configured to extend toward the longitudinal axis so that the positioner members connect to and retain the plurality of anchor members when the positioner members and blood filter are positioned within the catheter in a storage position;

f) the anchor end portions being the most proximate portion of the filter;

g) the positioner ends being the most distal portion of the filter positioning assembly;

h) wherein the filter and positioner members are movable to a preliminary dispensed position and to a fully deployed position;

i) wherein in said preliminary dispensed position, the positioner ends engage the vessel wall, wherein at least a portion of some of the anchor members remain in the catheter bore proximally of said catheter distal open end; and

j) wherein in said fully deployed position all the filter members of the filter are deployed in the vessel by at least partially retracting the plurality of positioner members with the catheter.

21. The push rod assembly of claim 20, wherein the plurality of positioner members are configured to press against a wall of the blood vessel as the filter positioning assembly and filter exit an end of the catheter.

22. The push rod assembly of claim 20, wherein the plurality of positioner members comprise Nitinol material.

23. The push rod assembly of claim 20, further comprising an extension wire oriented along the longitudinal axis and configured to contact a hub of the filter when the plurality of anchor members are retained by the plurality of positioner members.

24. The push rod assembly of claim 20, wherein the hub of the positioning assembly includes a radio-opaque material.

25. The push rod assembly of claim 20, further comprising a storage tube encompassing the filter positioning assembly and the blood filter.

26. The push rod assembly of claim 20, wherein the plurality of positioner members have a constant cross section over a majority of their length.

27. The push rod assembly of claim 20, wherein the plurality of positioner members have a variable cross section over a majority of their length.

28. The blood filter delivery apparatus of claim 20, wherein the plurality of positioner members are curved with a constant radius of curvature over a majority of their length.

29. A blood filter delivery apparatus for delivering a blood filter into a blood vessel, the vessel having a wall, the apparatus comprising:

a) a blood filter including a plurality of anchor members and having proximal and distal end portions;

b) a catheter having proximal and distal ends, a bore, and a distal catheter opening at the distal end of the catheter;

c) a filter positioning assembly situated within the catheter bore, the filter positioning assembly including a plurality of positioner members, each having a positioner distal end and a hub defining a plurality of splines, each of the splines being configured to cooperate with and retain the plurality of anchor members within the catheter when the ends of the positioner members are the most distal portion of the positioning assembly disposed within the catheter;

d) wherein the anchor members have proximal free ends that are the most proximal portion of the blood filter;

e) wherein in an initial, partially dispensed position the distal ends of the positioner members engage the vessel wall while at least a portion of some of the anchor members are located in the catheter bore proximally of said distal catheter opening; and

f) wherein in a fully deployed position all the filter members of the filter are deployed in the vessel by at least partially retracting the plurality of positioner members with the catheter.