Anti-pulmonary embolism filter and corresponding presentation and fitting kit

• US 5,413,586 A
• Filed: 09/14/1993
• Issued: 05/09/1995
• Est. Priority Date: 03/14/1991
• Status: Expired due to Fees

• Current Assignee: Ethnor
• Original Assignee: Ethnor
• Inventors: Musset, Dominique, Catteau, Gilles, Prou, Philippe, Dibie, Alain
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US08/117,131
• Time in Patent Office: 602 Days
• Field of Search: 606/191, 606/195, 606/198, 606/200, 623/1, 623/12, 604/104-106, 128/898, 128/899
• 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 2230/0006 circular

Abstract

The invention describes a pulmonary embolism prevention filter of the type made from an elastic wire with remanent spring effect, characterized int hat it comprises at least two wires (100, 200), each spirally shaped. The said two wires (100, 200) have at least substantially the same length and are connected in the vicinity of their ends.

Claims

1. Anti-pulmonary embolism filter made of resilient wire having a remanent spring effect shaped into a spiral structure comprising at least one first non-planar spiral continuous with and superimposed on at least one second non-planar spiral, the first spiral having two lateral turns connected by at least one middle turn having a diameter greater than each of the lateral turns, and the second spiral having turns having diameters no greater than the middle turn of the first spiral, the first and second spirals each having two ends and being joined together at least at one of their respective ends.

2. Anti-pulmonary embolism filter according to claim 1, characterized in that the first and second spirals each comprise a distinct wire having two ends, the distinct wires being joined together at least at one end of each wire.

3. Anti-pulmonary embolism filter according to claim 2, characterized in that the distinct wires are joined together at each of their respective ends.

4. Anti-pulmonary embolism filter according to claim 2, characterized in that the distinct wires are joined together at only one of their respective ends.

5. Anti-pulmonary embolism filter according to claim 2, characterized in that the wires are connected by means selected from the group consisting of adhesive bonding, soldering, and crimping.

6. Anti-pulmonary embolism filter according to claim 1, characterized in that the first and second spirals are formed by a single wire having two ends folded on itself.

7. Anti-pulmonary embolism filter according to claim 6, characterized in that the two ends of the single wire are joined together by means selected from the group consisting of adhesive bonding, soldering, and crimping.

8. Anti-pulmonary embolism filter according to claim 6, characterized in that the two ends of the single wire are fitted with open loops.

9. Anti-pulmonary embolism filter according to claim 6, characterized in that the single wire is folded on itself substantially half-way along.

10. Anti-pulmonary embolism filter according to claim 1, characterized in that the filter has at least one end which is formed by a bend in the resilient wire.

11. Anti-pulmonary embolism filter according to claim 1, characterized in that the filter has at least one end having a discontinuity in curvature in order to facilitate withdrawal of the filter by grasping the end.

12. Anti-pulmonary embolism filter according to claim 1, characterized in that the first and the second spirals are of opposite signs of helical twisting.

13. Anti-pulmonary embolism filter according to claim 1, characterized in that the first and the second spirals are of the same signs of helical twisting.

14. Anti-pulmonary embolism filter according to claim 1, characterized in that the spirals have substantially the same length.

15. Anti-pulmonary embolism filter according to claim 1, characterized in that the resilient wire is made of metal.

16. Anti-pulmonary embolism filter according to claim 1, characterized in that the resilient wire is made of an alloy selected from the group consisting of (i) copper and nickel and aluminum, (ii) copper and zinc and aluminum, (iii) copper and zinc and aluminum and nickel, and (iv) copper and tin and nickel.

17. Anti-pulmonary embolism filter according to claim 1, characterized in that the whole of the filter is coated with a thin layer of gold.

18. Anti-pulmonary embolism filter according to claim 1, characterized in that the turns of the second spiral have diameters substantially identical to each other and less than the diameter of the middle turn of the first spiral.

19. Anti-pulmonary embolism filter according to claim 1, characterized in that the second spiral has four turns.

20. Anti-pulmonary embolism filter according to claim 1, characterized in that the second spiral has a configuration identical to the first spiral that comprises three non-touching turns of a middle turn and two lateral turns of smaller diameter than the middle turn, the first and second spirals being mutually offset.

21. Anti-pulmonary embolism filter according to claim 20, characterized in that the diameter of the middle turn in each spiral is greater than 16 mm.

22. Anti-pulmonary embolism filter according to claim 20, characterized in that the diameter of the middle turn in each spiral is substantially equal to half the circumference of the vena cava in the zone where the filter is to be implanted.

23. Anti-pulmonary embolism filter according to claim 22, characterized in that the diameters of the two lateral turns in each spiral are substantially equal.

24. Anti-pulmonary embolism filter according to claim 1, characterized in that the turns of the first spiral are coaxial and the turns of the second spiral are coaxial but off-centered with respect to the turns of the first spiral.

25. Anti-pulmonary embolism filter according to claim 1, characterized in that the diameter of each turn of the second spiral lies between one half and one third of the diameter of the middle turn of the first spiral.

26. Anti-pulmonary embolism filter according to claim 1, characterized in that the first and second spirals comprise a plurality of turns of constant and identical diameters, the two spirals being offset from each other.

27. Anti-pulmonary embolism filter according to claim 1, characterized in that the first and the second spirals are formed, respectively, of wires of different diameters.

28. Anti-pulmonary embolism filter according to claim 1, characterized in that the wire of the first spiral has a diameter greater than the wire of the second spiral.

29. Anti-pulmonary embolism filter according to claim 1, characterized in that the resilient wire in each spiral has a diameter between 0.25 mm and 1 mm.

30. Anti-pulmonary embolism filter according to claim 1, characterized in that the resilient wire of the first spiral has a diameter of about 0.37 mm.

31. Anti-pulmonary embolism filter according to claim 30, characterized in that the wire of the second spiral has a diameter of about 0.30 mm.

32. Anti-pulmonary embolism filter according to claim 1, characterized in that the resilient wire forming each spiral has a length between 22 and 35 cm.

33. Anti-pulmonary embolism filter according to claim 1, characterized in that the diameter of the middle turn is at least 1.25 times the diameter of each of the lateral turns.

34. Anti-pulmonary embolism filter according to claim 1, characterized in that the diameter of the middle turn is at least 1.4 times the diameter of each of the lateral turns.

35. Anti-pulmonary embolism filter according to claim 1, characterized in that the turns of each spiral have substantially equal pitches.

36. Anti-pulmonary embolism filter according to claim 1, characterized in that the first spiral has a pitch of at least 3 mm.

37. Anti-pulmonary embolism filter according to claim 1, characterized in that the filter has an axial thickness of at least 9 mm.

38. Anti-pulmonary embolism filter according to claim 1, characterized in that the filter has an axial thickness and the diameter of the middle turn is at least twice the axial thickness.

39. Anti-pulmonary embolism filter according to claim 1, characterized in that each spiral comprises a distinct wire having two ends fitted with rounded radiopaque endpieces.

40. Anti-pulmonary embolism filter according to claim 39, characterized in that at least one of the endpieces is fitted with a threaded or tapped structure which can interact with a complementary pusher for fitting the filter.

41. Anti-pulmonary embolism filter according to claim 1, characterized in that it comprises more than two spirals.

42. Anti-pulmonary embolism filter according to claim 1, characterized in that one of the first and second spirals has an end constituting a closed loop projecting radially outside of the spirals.

43. Anti-pulmonary embolism filter according to claim 42, characterized in that the closed loop has a length of about 1.5 cm.

44. Presentation and fitting kit, characterized in that it comprises:

a filter in accordance with claim 1,

a catheter which can receive the filter in a sliding manner, and

means capable of transporting the filter in the catheter.

45. Kit according to claim 44, characterized in that the means capable of transporting the filter comprises a pusher fitted with a threaded or tapped structure capable of interacting with a complementary endpiece of the filter.

46. Kit according to claim 44, characterized in that it further comprises a withdrawal instrument comprising a flexible tube which accommodates a flexible pusher fitted with a clamping means at its proximal end.

47. Kit according to claim 46, characterized in that the clamping means is formed by two symmetrical resilient jaws pressed apart at rest.

48. Kit according to claim 46, characterized in that it further comprises resilient means pressing the pusher and the clamping means in a retracted rest position in the flexible tube.

49. Anti-pulmonary embolism filter according to claim 1, wherein the first and the second spirals are connected respectively at their two ends and have substantially the same length.

63. Anti-pulmonary embolism filter according to claim 1, characterized in that the filter has an axial thickness and the diameter of the middle turn is at least 2.5 times the axial thickness.

50. Anti-embolism filter for implanting in a vena cava so as to retain any clot migrating with the blood before said clot penetrates into the heart, to avoid pulmonary embolism while allowing free flowing of the blood in the vena cava, said filter being made of resilient wire having a remanent spring effect shaped into a spiral structure comprising at least one first non-planar spiral continuous with and superimposed on at least one second non-planar spiral, the first spiral having two lateral turns connected by at least one middle turn having a diameter greater than 16 mm and greater than each of the lateral turns, in order to ensure that the filter is optimally held in place by flattening of the vena cava when said filter is implanted in said vena cava with its axis perpendicular to the axis of said vena cava, and the second spiral having turns having diameters no greater than the middle turn of the first spiral, the first and the second spirals each having two ends and being joined at least at one of their respective ends.

51. Anti-embolism filter according to claim 50, wherein the first and the second spirals are connected respectively at their two ends and have substantially the same length.

52. Anti-embolism filter according to claim 50, wherein the first and the second spirals are made from a single wire folded on itself substantially half-way along.

53. Anti-embolism filter according to claim 50, wherein one of the ends of the two spirals constitutes a closed loop projecting radially outside of the spirals for facilitating withdrawal of the filter by grasping this loop.

54. Anti-embolism filter according to claim 50, wherein the second spiral comprises two lateral turns connected by at least one middle turn having a diameter greater than each of the lateral turns.

55. Anti-pulmonary embolism filter made of a resilient wire having a remanent spring effect folded on itself substantially half-way along and comprising at least one first non-planar spiral continuous with and superimposed on at least one second non-planar spiral, the first spiral having two lateral turns connected by at least one middle turn having a diameter greater than each of the lateral turns, and the second spiral having turns having diameters no greater than the middle turn of the first spiral.

56. Anti-pulmonary embolism filter according to claim 55, wherein the first and second spirals each have two ends, are joined together at each of their respective ends, and have substantially identical lengths.

57. Anti-pulmonary embolism filter according to claim 55, wherein the first and second spirals each have two ends and one of the ends of the first and second spirals constitutes a closed loop projecting radially outside of the spirals for facilitating withdrawal of the filter by grasping this loop.

58. Anti-pulmonary embolism filter according to claim 55, wherein the second spiral comprises two lateral turns connected by at least one middle turn having a diameter greater than each of the lateral turns.

61. Anti-embolism filter according to claim 55, wherein one of the ends of the first and second spirals constitutes a closed loop projecting radially outside of the spirals for facilitating withdrawal of the filter by grasping this loop.

62. Anti-embolism filter according to claim 55, wherein the second spiral comprises two lateral turns connected by at least one middle turn having a diameter greater than each of the lateral turns.

59. Anti-pulmonary embolism filter made of resilient wire having a remanent spring effect shaped into a spiral structure comprising at least one first non-planar spiral continuous with at least one second non-planar spiral, the first and the second spirals having substantially the same length, each spiral having two ends and being joined together at each of their respective ends, the first spiral having two lateral turns connected by at least one middle turn having a diameter greater than each of the lateral turns, and the second spiral having turns having diameters no greater than the middle turn of the first spiral.

60. Anti-embolism filter according to claim 59, wherein the first and the second spirals are made from a single wire folded on itself substantially half-way along.