Recoverable thrombosis filter

• US 5,370,657 A
• Filed: 03/26/1993
• Issued: 12/06/1994
• Est. Priority Date: 03/26/1993
• Status: Expired due to Term

• Current Assignee: Lifescreen Sciences LLC (Acacia Research Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Irie, Toshiyuki
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/042,424
• Time in Patent Office: 620 Days
• Field of Search: 606/152-155, 606/191, 606/108, 606/198, 606/200, 128/898, 128/899, 604/104, 604/105
• US Class Current: 606/200
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• 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 2230/008 paraboloidal

Abstract

A thrombosis filter that has an improved filtering function and can be securely anchored at a desired location and be removed through an endovenous route even after the growth of neointima. The thrombosis filter of this invention includes a first and a second filtering and holding unit, each unit including a coupling mechanism at its outer extremity in the form of a hook, and a plurality of resilient struts which include vein wall junction portions that lie parallel to the vein wall and are biased into contact therewith. The preferred embodiment includes picks that impale the vein wall to a limited depth. The units are interconnected by a core shaft which consists of a compression member and a pair of core wires.

Claims

1. A filter formed along a longitudinal axis, to be placed in the blood vessel of a patient for trapping clots,

said filter including first and second units that are spaced from each other along the filter'"'"'s longitudinal axis,

each of said units including a central hub into which a plurality of struts are anchored such that they radiate outwardly therefrom at an acute angle to said longitudinal axis in the direction toward the other of said units,

said first and second units being interconnected by an elongated compression member extending along said longitudinal axis, each end of said compression member being connected to the central hub of one of said units,

the struts of the first unit including initial portions that form a filter basket having a concave side that functions to capture clots that are flowing through the blood vessel toward the concave side of the filter basket, the struts of the first unit are bent toward the longitudinal axis at the ends of their initial portion to form vein wall junction portions that extend parallel to the vein wall and are biased into engagement therewith such that the vein wall junction portions function to anchor the filter at a desired position within the blood vessel,

the struts of the second unit including initial portions that form a cone, the struts of the second unit are bent toward the longitudinally axis at the ends of their initial portion to form vein wall junction portions that extend parallel to the vein wall.

2. The invention as set forth in claim 1, wherein each unit of said filter includes a core wire, one end of each core wire is anchored in the unit'"'"'s central hub and extends from its anchor toward the other unit, said core wires terminating in free ends short of said other unit.

3. The invention as set forth in claim 2 wherein said filter includes a coupling mechanism at each of its ends, each of said coupling mechanisms being connected to the central hub of its associated unit and being accessible percutaneously through the blood vessel in which the filter is implanted.

4. The invention as set forth in claim 2 in which the struts of said first and second units are made of spring material and include an anchoring portion that are rigidly anchored in said central hubs, said struts being equally spaced around the central hubs such that engagement by the vein wall junction portions of the struts causes the corresponding central hubs to be located along said longitudinal axis.

5. The invention as set forth in claim 1 wherein said filter includes a coupling mechanism at each of its ends, each of said coupling mechanisms being connected to the central hub of its associated unit and being accessible percutaneously through the blood vessel in which the filter is implanted.

6. The invention as set forth in claim 1 in which the struts of said first and second units are made of spring material and include an anchoring portion that are rigidly anchored in said central hubs, said struts being equally spaced from adjacent struts such that engagement by the vein wall junction portions of the struts causes the corresponding central hub to be located along said longitudinal axis.

7. The invention as set forth in claim 1, wherein said vein wall junction portions of the struts of the first unit are biased into engagement with the vein wall to anchor the filter at a desired position within the blood vessel.

8. A filter formed along a longitudinal axis, to be placed in the blood vessel of a patient for trapping clots,

said filter including first and second units that are spaced from each other along the filter'"'"'s longitudinal axis,

each of said units including a central hub into which a plurality of struts are anchored such that they radiate outwardly therefrom at an acute angle to said longitudinal axis in the direction toward the other of said units,

said first and second units being interconnected by an elongated compression member extending along said longitudinal axis, each end of said compression member being connected to the central hub of one of said units,

the struts of the first unit including initial portions that form a filter basket having a concave side that functions to capture clots that are flowing through the blood vessel toward the concave side of the filter basket, the struts of the first unit are bent toward the longitudinally axis at the ends of their initial portion to form vein wall junction portions that extend parallel to the vein wall and are biased into contact therewith such that the vein wall junction portions function to anchor the filter at a desired position within the blood vessel,

the struts of the second unit including initial portions that form a cone, the struts of the second unit are bent toward the longitudinally axis at the ends of their initial portion to form vein wall junction portions that extend parallel to the vein wall and are biased into engagement therewith such than the vein wall junction portions function to anchor the filter at a desired position within the blood vessel,

said second unit further including anchor legs that are anchored in said central hub and radiate outwardly therefrom at an acute angle to said longitudinal axis generally parallel to the initial portions for the secondary unit struts, said anchor legs extend past the intersection of the initial and vein wall junction portion of the second unit struts and terminate in picks that can pierce the vein wall at an acute angle thereto.

9. The invention as set forth in claim 8, wherein the struts of the first unit are bent toward the longitudinally axis at the ends of their vein wall junction portion to form inwardly directed end portions that will avoid piercing the vein wall.

10. The invention as set forth in claim 9 wherein said first unit has six struts and the second unit has four struts.

11. The invention as set forth in claim 8, wherein the struts of the second unit are bent toward the longitudinally axis at the ends of their vein wall junction portion to form inwardly directed end portions that will avoid piercing the vein wall.

12. The invention as set forth in claim 11 wherein said first unit has six struts and the second unit has four struts.

13. The invention as set forth in claim 8 wherein said first unit has six struts and the second unit has four struts.

14. The invention as set forth in claim 13 wherein said first unit has six struts and the second unit has four struts.

15. The invention as set forth in claim 13 wherein said anchor legs are each connected to the initial portion of a second unit strut.

16. The invention as set forth in claim 13 wherein that are two anchor legs.

17. The invention as set forth in claim 8 wherein said anchor legs are each connected to the initial portion of a second unit strut.

18. The invention as set forth in claim 8 wherein that are two anchor legs.

19. A method of recovering a filter that has been implanted in the vascular system of a patient, said filter being of the type that extends along the longitudinal axis of a blood vessel and includes first and second units connected by a compression member, said filter includes coupling mechanisms at each of its ends, comprising the steps of:

(a) inserting a first recovery tube into the patient'"'"'s vascular system that leads to the first end of the implanted filter;

(b) advancing the first recovery tube through the patients vascular system to the point where the distal end of the first recovery tube is in the vicinity of a first end of the implanted filter;

(c) inserting a second recovery tube into the patient'"'"'s vascular system that leads to a second end of the implanted filter;

(d) advancing the second recovery tube through the patient'"'"'s vascular system to the point where the distal end of the second recovery tube is in the vicinity of the second end of the implanted filter;

(e) providing a first elongated member having a coupling mechanism, that is complementary to the coupling mechanism on the filter;

(f) advancing the first elongated member through the first recovery tube until the coupling mechanism on the first end of the filter and on the distal end of the first elongated member are adjacent;

(g) manipulating the first elongated member from its proximal end to cause the adjacent coupling mechanism on the first end of the filter and the distal end of the first elongated member to become attached;

(h) provide a second elongated member having a coupling mechanism, is complementary to the coupling mechanisms on the filter;

elongated member;

(i) advancing the second elongated member through the second recovery tube until the coupling mechanisms on the second end of the filter and on the distal end of the second elongated member are adjacent;

(j) manipulating the second elongated member from its proximal end to cause the adjacent coupling mechanisms on the second end of the filter and the distal end of the second elongated member to become attached;

(k) applying a pressure in the proximal direction on the first and second elongated members causing said compression member to expand and said first and second filter units to move away from each other and to separate from the vessel;

(l) continue to apply pressure in the proximal direction on the first and second elongated members until said compression member fractures and said first and second filter units are separated; and

(m) withdraw the recovery tubes, each containing one of the filter units, from the patient.

20. The method as set forth in claim 19 wherein said elongated members are hollow tubes and said coupling mechanism at the distal ends of said elongated members are formed by:

(1) doubling cords over so that the cords have a loop at one end;

(2) advancing the cord, loop end first, through said hollow tubes toward their distal end, until the loop exits the hollow tubes at the distal end and functions as the coupling mechanism for coupling to said filter.

21. The method as set forth in claim 19 wherein said elongated members are stiff wires having coupling mechanisms at their distal ends.

22. A method of removing a filter that has been implanted in a patients vascular system comprising the steps of:

(a) percutaneously inserting a pair of recovery tubes into vessels of the patient'"'"'s vascular system that lead to both ends of the filter;

(b) advancing the pair of recovery tubes through the patient'"'"'s vascular system until their distal ends are adjacent to the filter;

(c) advancing an elongated member having a coupling mechanism on its distal end through each of said recovery tubes until the coupling mechanisms contact the filter;

(d) coupling said coupling mechanisms to the opposite ends of the filter;

(e) exerting a tension force on said elongated members in opposite directions until the filter fractures into two distinct and separate units;

(f) pulling each of the distinct and separate units into the distil end of a recovery tube; and

(g) percutaneously withdrawing the recovery tubes, each containing one of the distinct and separate units, from the patient.

23. A method on implanting a filter, of the type that includes first and second units connected by a resilient coupling member and having coupling mechanisms at its first end and at its second end, into a vessel of a patient and recovering the filter when it is no longer needed, comprising the steps of:

(a) measuring the inside diameter of the vessel into which the filter is to be implanted;

(b) selecting a filter that has an unstressed diameter in excess of the inside diameter into which it will be implanted;

(c) implanting percutaneously the selected filter into the patients vessel;

(d) performing the following step to percutaneously remove the filter when it is no longer needed by the patient;

(e) inserting a first recovery tube into the patient'"'"'s vessel that leads to the implanted filter;

(b) advancing the first recovery tube through the patients vascular system to the point where the distal end of the first recovery tube is in the vicinity of the first end of the implanted filter;

(c) inserting a second recovery tube into the patient'"'"'s vessel that leads to the second end of the implanted filter;

(d) advancing the second recovery tube through the patients vascular system to the point where the distal end of the second recovery tube is in the vicinity of the second end of the implanted filter;

(e) provide a coupling mechanism, that is complementary to the coupling mechanisms on the filter, on the distal end of a first elongated member;

(f) advancing the first elongated member through the first recovery tube until the complementary coupling mechanisms on the first end of the filter and on the distal end of the first elongated member are adjacent;

(g) manipulating the first elongated member from its proximal end to cause the adjacent coupling mechanism on the first end of the filter and the distal end of the first elongated member to become attached;

(h) provide a coupling mechanism, that is complementary to the coupling mechanisms on the filter, on the distil end of a second elongated member;

(f) advancing the second elongated member through the second recovery tube until the complementary coupling mechanisms on the second end of the filter and on the distal end of the second elongated member are adjacent;

(g) manipulating the second elongated member from its proximal end to cause the adjacent coupling mechanisms on the second end of the filter and the distal end of the second elongated member to become attached;

(k) applying pressure in the proximal directions on the first and second elongated members causing said compression member to expand and said first and second filter units to move away from each other and separate from the vessel;

(l) continuing to apply pressure in the proximal directions on the first and second elongated members until said compression member fractures and said first and second filter units are separated from each other and are pulled into the distal ends of the first and second recovery tubes; and

(m) withdrawing the recovery tubes, each containing one of the filter units, from the patient.

24. The invention as set forth in claim 23 wherein the selected filter has an unstressed diameter equal to about 1.3 times the inside diameter of the vessel into which it will be implanted.