Cerebral vasculature device

• US 20080097401A1
• Filed: 09/22/2006
• Published: 04/24/2008
• Est. Priority Date: 09/22/2006
• Status: Abandoned Application

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Friedman, Nathan L., Vonesh, Michael J., Trapp, Benjamin M.
• Application Number:
  US11/526,269
• Publication Number:
  US 20080097401A1
• Time in Patent Office: Days
• US Class Current: 604/527
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: D04C 1/06 Braid or lace serving particular purposes
• CPC Class Codes: D10B 2101/20 Metallic fibres
• CPC Class Codes: D10B 2509/06 Vascular grafts; stents

Abstract

Novel cerebral vasculature devices are disclosed, including thrombectomy removal devices that include a continuous braided structure, a proximal portion, a distal portion, and a first expandable portion located between the proximal portion and the distal portion. The braided structure includes a plurality of wires. The proximal portion and the distal portion include polymer imbedded at least partially into the braided structure. The device is useful for removing thrombus from a patient'"'"'s vasculature.

Claims

1. Cerebral vascular device comprising:

continuous braided structure comprising a plurality of wires, the braided structure having a proximal portion, a distal portion, a first expandable portion between the proximal portion and the distal portion, and a lumen extending from the proximal portion to the distal portion;

the proximal portion and the distal portion each having an outer diameter and an inner diameter and further including polymer imbedded at least partially into the braided structure;

core wire having a proximal end and a distal end, the core wire located within the lumen and extending from the braided structure proximal portion to a point at or distal to the braided structure distal portion; and

atraumatic component attached to the core wire distal end and having an outer diameter at least equal to the inner diameter of the braided structure distal portion.

2. The cerebral vascular device of claim 1, wherein the atraumatic component is selected from the group consisting of polymer tubular structures and metal coils.

3. The cerebral vascular device of claim 2, wherein the metal coil comprises radioopaque material.

4. The cerebral vascular device of claim 3, wherein the radioopaque material comprises a material selected from the group consisting of platinum, gold, iridium, and platinum/iridium alloy.

5. The cerebral vascular device of claim 1, wherein the braided structure proximal portion and distal portion have an outer diameter of about 0.020 inch or less.

6. The device of claim 5, wherein the braided structure proximal portion and distal portion have an outer diameter of about 0.017 inch or less.

7. The device of claim 1, wherein the plurality of wires comprise metal wires.

8. The device of claim 7, wherein the plurality of wires comprise nitinol.

9. The device of claim 1, wherein the polymer comprises a material selected from the group consisting of polyimide, peba, polyurethane, nylon, silicone, and polyethylene.

10. The device of claim 1, wherein the polymer prevents radial expansion of the braided structure proximal portion and distal portion during expansion of the expandable portion.

11. The device of claim 1, wherein the polymer substantially completely imbeds the proximal portion and the distal portion of the braided structure.

12. The device of claim 1, wherein the braided structure is comprised of a plurality of wires selected from the group consisting of round profiles and flat profiles and combinations thereof.

13. The device of claim 12, wherein the wires have a round profile.

14. The device of claim 13, wherein a majority of the wires have an outer diameter of about 0.002 inch or less.

15. The device of claim 14, wherein a majority of the wires have an outer diameter of about 0.0015 inch or less.

16. The device of claim 15, wherein a majority of the wires have an outer diameter of about 0.001 inch or less.

17. The device of claim 1, wherein at least one of the wires comprises radioopaque material.

18. The device of claim 17, wherein the radioopaque material comprises a material selected from the group consisting of platinum, gold, iridium and platinum/iridium alloy.

19. The device of claim 1, further comprising at least one radioopaque marker band.

20. The device of claim 19, wherein the device comprises at least 2 radioopaque marker bands.

21. The device of claim 20, wherein at least one marker band is located distal to the expandable portion and at least one marker band is located proximal to the expandable portion.

22. The device of claim 1, wherein the polymer comprises radioopaque material.

23. The device of claim 22, wherein the radioopaque material comprises a material selected from the group consisting of barium sulfate and bismuth trioxide.

24. The device of claim 19, wherein the at least one radioopaque marker band is essentially flush with the outer diameter of the proximal and distal portions of the device.

25. The device of claim 1, wherein the device is attached to the distal end of a tubular structure.

26. The device of claim 25, wherein the tubular structure is a continuation of the proximal portion of the braided structure.

27. The device of claim 25, wherein the tubular structure has an outer diameter of about 0.020 inch or less.

28. The device of claim 1, wherein the expandable portion has a length in its unexpanded state of about 1 cm or less.

29. The device of claim 28, wherein the expandable portion has a length of about 5 mm or less.

30. The device of claim 29, wherein the expandable portion has a length of about 4 mm.

31. The device of claim 12, wherein the plurality of wires numbers 48 wires or more.

32. The device of claim 12, wherein the plurality of wires numbers 32 wires or more.

33. The device of claim 12, wherein the plurality of wires numbers 16 wires or more.

34. The device of claim 1, wherein the braided structure comprises wires oriented at an angle of about less than or equal to 10 degrees as measured from the longitudinal axis of the braided structure.

35. The device of claim 34, wherein the braided structure comprises wires oriented at an angle of about less than or equal to 8 degrees as measured from the longitudinal axis of the braided structure.

36. The device of claim 1, wherein the expandable portion has a diameter in its maximum expanded state of about 6 mm or less.

37. The device of claim 36, wherein the expandable portion has a diameter in its maximum expanded state of about 4 mm or less.

38. The device of claim 37, wherein the expandable portion has a diameter in its maximum expanded state of about 3.3 mm.

39. The device of claim 25, wherein the core wire extends for at least the length of the tubular structure.

40. The device of claim 39, wherein the combination of the core wire and the tubular structure has a change in flexibility from a proximal point to a distal point thereon.

41. The device of claim 40, wherein the distal point of the tubular structure is more flexible than the proximal point of the tubular structure.

42. The device of claim 39, wherein a handle is coupled to the core wire and the tubular structure, the handle providing for actuation of the expandable portion.

43. The device of claim 1, wherein the expandable portion is atraumatic to a patient'"'"'s vessel when in its maximum expanded state.

44. The device of claim 43, wherein the expandable portion is suitable for removing a clot from the patient'"'"'s vessel.

45. The device of claim 1, wherein the expandable portion has a maximum expanded diameter being equal to or larger than the diameter of the patient'"'"'s target vessel.

46. The device of claim 1, wherein the braided structure further comprises a second expandable portion.

47. The device of claim 46, wherein the braided structure further comprises an intermediate portion located between the first expandable portion and the second expandable portion.

48. The device of claim 47, wherein the intermediate portion comprises polymer imbedded at least partially into the braided structure.

49. The device of claim 47, wherein the intermediate portion is radially constrained by a polymer covering.

50. The device of claim 47, wherein the intermediate portion is radially constrained by a metal band.

51. The device of claim 47, wherein the intermediate portion is of a higher braid angle than the expandable portions.

52. The device of claim 25, wherein the device and tubular member are sized to be suitable for delivery through a microcatheter.

53. The device of claim 52, wherein the device and tubular member do not impose bending force to a straight microcatheter.

54. The device of claim 1, wherein the first expandable portion comprises a plurality of wires oriented at a first angle and at least a portion of the braided structure comprises wires oriented at a second angle different from the first angle.

55. The device of claim 1, wherein the device is removably attached to a distal end of a catheter shaft.

56. The device of claim 1, wherein the expandable portion is provided with an outer polymer cover.

57. The device of claim 56, wherein the outer polymer cover comprises ePTFE.

58. Method for making a cerebral vascular device comprising the steps of:

providing a continuous braided structure having a length, a lumen extending therethrough, and having polymer at least partially imbedded therein for substantially the entire length of the braided structure;

removing at least a portion of the polymer from the braided structure to form an expandable portion, a proximal portion having polymer at least partially imbedded therein and a distal portion having polymer at least partially imbedded therein, the expandable portion being located between the proximal portion and the distal portion;

attaching an atraumatic component to a core wire, the core wire having a proximal end and a distal end;

locating the core wire within the lumen, the core wire extending from the braided structure proximal portion to a point distal to the braided structure distal portion; and

wherein the atraumatic component has an outer diameter at least equal to the inner diameter of the braided structure distal portion.

59. The method of claim 58, wherein the polymer is provided by a dip-coating process.

60. The method of claim 58, wherein the polymer is removed by laser ablation.

61. The method of claim 58, wherein the polymer is removed by an abrasion process.

62. The method of claim 61, wherein the abrasion process comprises using sodium bicarbonate.