Blood clot filtering

• US 6,013,093 A
• Filed: 11/10/1997
• Issued: 01/11/2000
• Est. Priority Date: 11/28/1995
• Status: Expired due to Fees

• Current Assignee: Lifescreen Sciences LLC (Acacia Research Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Suon, Naroun, Nott, Sepideh H., Sandock, deceased, David L., Kim, Hannah S.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US08/849,392
• Time in Patent Office: 792 Days
• Field of Search: 606/200, 606/191-199, 604/104, 623/1, 623/11, 623/12, 623/13
• 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 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

This invention is a blood clot filter having an anchoring portion (402) which includes a generally cylindrical self-expanding body. A generally conical filtering portion (400) is axially aligned with the cylindrical body (402), has an open proximal end (406) coupled to a distal end of the anchoring portion, and an apical distal end (404). In a preferred embodiment, the filter portion (400) is formed from strands (410) of resilient material that extend from the apical distal end (404) to the open proximal end (406). The strands (410) form twisted pairs (408) that converge at the apical distal end (404). The strands (410) diverge from the twisted pairs (408) in crossing paths to form a pattern of open filtering cells (A)(B)(C). The filter also has hooks (413) coupled to the anchoring portion (402) and formed from compliant material having an original shaped that bends under stress yet returns to its original shaped when unstressed.

Claims

1. A filter sized and constructed to be compressed and passed through the vasculature of a patient to be anchored against an inner wall surface of a blood vessel for capturing blood clots in a blood stream passing therethrough, said filter comprising:

an anchoring portion comprising a generally cylindrical self-expanding body formed from resilient material, said generally cylindrical body having proximal and distal ends and defining an axial direction and having a structure of variable diameter that is expandable from a low-profile compressed condition to a larger profile expanded condition, wherein said resilient material urges said generally cylindrical body to radially expand and to thereby apply anchoring radial force against the inner wall surface of the blood vessel; and

a filtering portion aligned with said generally cylindrical body, and having an open proximal end supported near the distal end of said anchoring portion, wherein the filtering portion includes elongated strands structured to provide a capture cross-section that prevents large clots from passing therethrouqh.

2. The filter of claim 1 wherein said anchoring portion and said filtering portion are substantially non-overlapping to achieve a low profile compressed condition for delivery of the filter through the vasculature.

3. The filter of claim 2, wherein said filtering portion is formed from a plurality of the elongated strands arranged to form a generally conical structure to guide blood clots in the blood stream flowing therepast to an apical distal end of said generally conical filtering portion for lysing.

4. The filter of claim 3 wherein said elongated strands are fixedly attached to one another only at the apex of said generally conical filtering portion.

5. the filter of claim 3, wherein said elongated strands define a plurality of neighboring filtering cells.

6. The filter of claim 5, wherein the cells are arranged in a plurality of coaxial rings of neighboring cells, each ring being progressively more distant from the apical distal end and having cells that are larger than the cells of the ring next closest the apical distal end.

7. The filter of claim 6, wherein neighboring filtering cells are loosely coupled together at the respective areas of contact between neighboring cells.

8. The filter any of claim 5, wherein neighboring cells are coupled together by helical twisting of portions of respective elongated strands of neighboring cells.

9. The filter of claim 7 wherein the portion of the twisted together elongated strands are capable of slight mutual separation or rotation to accommodate changes in the shapes of said cells from the expanded to the compressed conditions.

10. The filter as in any one of claims 3-6, wherein said elongated strands are spirally arranged from the proximal end of said filtering portion to the apical distal end of said filtering portion.

11. The filter of claim 3, wherein said elongated strands are selected to have sufficient rigidity to maintain the generally conical shape of said filtering portion in a flowing blood stream.

34. The filter as in either claim 1 or 12, wherein said self-expanding anchoring portion comprises a ring of neighboring cells.

35. The filter of claim 34, wherein the cells of said anchoring portion are self-expanding.

36. The filter of claim 34, wherein the neighboring cells of the anchoring portion are fixedly coupled together at respective areas of contact.

37. The filter of claim 34, the cells of said anchoring portion are formed from one or more resilient elongated strands.

38. The filter of claim 34, when the cylindrical body is in a compressed condition said cells of the anchoring portion are elongated in the axial direction.

43. The filter of claim 34, wherein the strands extend beyond the open proximal end to form the body of the anchor portion.

44. The filter as in any one of claims 1, 12, 13, 18, 19, or 30, wherein said filter is coated with a drug for beneficial physiological effect.

45. The filter of claim 44, wherein the drug improves in vivo capability.

12. A filter sized and constructed to be compressed and passed through the vasculature of a patient for anchoring against an inner wall surface of a blood vessel for capturing blood clots in a blood stream passing therethrough, said filter comprising:

a cylindrical anchoring portion having proximal and distal ends and defining an axial direction and having a structure of variable size diameter expandable from a low-profile compressed condition to a larger profile expanded condition; and

a filter axially aligned with said generally cylindrical body having an open proximal end supported from the distal end of said anchoring portion and having a distal end, said filter defined by elongated spiral strands,

wherein said cylindrical anchoring portion and said filter are substantially nonoverlapping to achieve a low profile compressed condition for delivery of the filter through the vasculature.

13. A filter having a longitudinal axis, sized and constructed to be compressed and passed through the vasculature of a patient and to be expanded and anchored against an inner wall surface of a blood vessel for capturing blood clots in a blood stream passing therethrough, said filter comprising a filter portion having a closed distal end and an open proximal end, the filter portion comprising two sets of strands formed of resilient material that spiral in opposite directions in a crossing pattern that defines a plurality of open cells, the strands being slidably movable relative to each other at regions where they cross.

14. The filter of claim 13, wherein the cells are arranged in a plurality of rings of neighboring cells, each ring being progressively more distant from the distal end and having cells that are larger than the cells of the ring next closest the distal end.

15. The filter of claim 14, wherein the cells of a first ring closest to the, distal end each comprise two sides closest to the distal end that are formed of twisted pairs of the strands, and wherein the strands of each twisted pair diverge from the twisted pair in the opposite spiral directions.

16. The filter of claim 15, wherein the twisted pairs converge at the distal end.

17. The filter of claim 14, wherein the plurality of rings comprises:

a ring nearest to the, distal end, comprised of cells each including only one of the crossing regions of relatively slidable strands;

a ring nearest the open end comprised of cells each including only one of the crossing regions of relatively slidable strands; and

at least one intermediate ring comprised of cells each including only three of the crossing regions of relatively slidable strands.

31. The filter as in any one of claims 3, 13, 18, 19 or 30, wherein the strands are formed from a member of the group consisting of nitinol, a temperature-sensitive shape memory material having a transition temperature around body temperature, a plastically deformable material, and an elastic material having a core formed from a radiopaque material.

32. The filter as in any one of claims 3, 13, 18, 19 or 30, wherein the strands form a woven pattern such that the strands are slidably movable relative to each other at their crossing regions.

33. The filter as in any one of claims 13, 18, 19 or 30, comprising an anchoring portion supporting the open proximal end of the filter portion, the anchoring portion comprising a self-expansible, substantially cylindrical-shaped body axially aligned with the filter portion, formed of a resilient material that urges the self-expansible body to radially expand and apply anchoring radial force against the inner wall surface of the blood vessel.

39. The filter of claim 33, wherein one or more hooks are fixedly coupled to said anchoring portion, the one or more hooks being formed from compliant material having an original shape that bends under a stress and that returns to its original shape when the stress is removed, said one or more hooks respectively projecting from said anchoring portion at an acute angle with respect to the axial direction for engagement with a vessel wall, said one or more hooks further being deflectable toward said anchoring portion for achieving a low-profile.

40. The filter of claim 39, wherein said one or more hooks are formed from nitinol.

41. The filter of claim 39, wherein said one or more hooks preferentially bend toward and away from said vessel wall engaging portion.

42. The filter of claim 39, wherein said one or more hooks are formed from flat nitinol wire having a width dimension and having a thickness dimension substantially smaller than said width dimension for achieving preferential bending, said flat nitinol wire being oriented so that the thickness dimension of said flat nitinol wire coincides with a radial direction of the anchoring portion.

18. A filter sized and constructed to be passed through the vasculature of a patient in a compressed condition and to be anchored in an expanded condition against an inner wall surface of a blood vessel for capturing blood clots in a blood stream passing therethrough, said filter including a filter portion that is substantially conical-shaped in the expanded condition and having an apical distal end and an open proximal end, the filter portion comprising two sets of strands of spring material that spiral in opposite directions in a crossing pattern, the strands being relatively slidable at regions where they cross, in the expanded condition the crossing pattern defining a plurality of four-sided, open cells, the cells being arranged in rings having a common axis, the cells of each ring being progressively larger with distance from the apical center, a first ring nearest to the apical center comprised of cells each including only one of the crossing regions of relatively slidable strands, at least one intermediate ring comprised of cells each including at least two of the crossing regions of relatively slidable strands, and a third ring nearest the open end comprised of cells each including only one of the crossing regions of relatively slidable strands, wherein the cells of the first ring each comprise two sides closest to the apical center that are formed of twisted pairs of the strands, wherein the twisted pairs join at the apical center.

19. A filter having a longitudinal axis, said filter sized and constructed to be passed through the vasculature of a patient in a radially compressed condition and to be anchored against an inner wall surface of a blood vessel in a radially expanded condition for capturing blood clots in a blood stream passing therethrough, said filter comprising a filter portion that includes a distal end, an open proximal end of variable size diameter, and elongated strands extending from the distal end to the open proximal end, the strands being twisted together in twisted groups which converge at the distal end to define common borders of a plurality of open filtering cells.

20. The filter of claim 19, wherein the twisted groups of strands are twisted pairs of strands that converge at the distal end.

21. The filter of claim 19, wherein the strands forming each of the twisted groups diverge from each other at a location between the distal end and the open proximal end and extend in paths therefrom to the open proximal end, the strands diverging from the twisted groups and the twisted groups together defining the plurality of open cells.

22. The filter of claim 21, wherein the path of each strand diverging from the twisted groups crosses the path of at least one other strand diverging from the twisted groups.

23. The filter of claim 22, wherein the strands diverging from the twisted groups are slidably movable relative to each other at regions where they cross.

24. The filter of claim 21, wherein each strand is joined to another strand at the open proximal end.

25. The filter of claim 21, wherein the cells are arranged in a plurality of rings of neighboring cells, each ring being progressively more distant from the distal end and having cells that are larger than the cells of the ring next closest the distal end.

26. The filter of claim 25, wherein the cells of a first ring nearest to the distal end and the cells of a second ring farthest from the distal end each include one crossing region wherein the strands are slidably movable relative to each other, and wherein the cells of a third ring between the first and second rings each include at least two crossing regions wherein the strands are slidably movable relative to each other.

27. The filter of claim 25, wherein each ring comprises at least six cells.

28. The filter of claim 21, wherein the paths of the strands that diverge from the twisted groups are substantially straight.

29. The filter of claim 21, wherein the paths of the strands that diverge from each of the twisted groups spiral in different directions.

30. A filter sized and constructed to be passed through the vasculature of a patient in a compressed condition and to be anchored in an expanded condition against an inner wall surface of a blood vessel for capturing blood clots in a blood stream passing therethrough, said filter including a filter portion that is substantially conical-shaped in the expanded condition, an apical distal end and an open proximal end, the filter portion comprising strands that extend from an open proximal end of the filter portion to an apical distal end, pairs of the strands forming twisted pairs that converge at the apical distal end, each of the strands forming each twisted pair diverging from the twisted pair near the apical distal end and extending therefrom in an approximately straight path that crosses a strand from a neighboring twisted pair, each strand being joined to another strand at the open proximal end, the crossing strands being relatively slidable at regions where they cross, in the expanded condition the crossing strands and the twisted pairs defining a plurality of four-sided, open cells, the cells being arranged in coaxial rings, the cells of each ring being progressively larger with distance from the apical distal end, the cells of a first ring nearest to the apical distal end and the cells of a second ring nearest the open proximal end each including only one of the crossing regions of relatively slidable strands, and the cells of an intermediate third ring each including two of the crossing regions of relatively slidable strands.