Locking component for an embolic filter assembly

• US 20070162071A1
• Filed: 01/26/2007
• Published: 07/12/2007
• Est. Priority Date: 03/19/2004
• Status: Active Grant

• Current Assignee: Aaron Baldwin, David Burkett, Kathern Lind, Pablito Buan, Philip Yip, Robert Esselstein, Robert Hazelden, Ryan Grandfield, Thomas Tokarchik, Wayne Cornish
• Original Assignee: Aaron Baldwin, David Burkett, Kathern Lind, Pablito Buan, Philip Yip, Robert Esselstein, Robert Hazelden, Ryan Grandfield, Thomas Tokarchik, Wayne Cornish
• Inventors: Baldwin, Aaron, Grandfield, Ryan, Buan, Pablito, Burkett, David, Cornish, Wayne, Esselstein, Robert, Tokarchik, Thomas, Yip, Philip, Lind, Kathern, Hazelden, Robert
• Granted Patent: US 7,879,065 B2
• Time in Patent Office: Days
• 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 2002/015 Stop means therefor
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical

Abstract

A locking component for locking a medical device onto a guide wire. Such medical devices include, for example, an embolic filter assembly used to capture embolic material that may be created and released into a patient'"'"'s vasculature during a stenting or angioplasty procedure. The embolic filter assembly tracks along the guide wire, and is delivered to a treatment site where it is locked in place and deployed. The locking component enables the filter assembly to lock onto any standard guide wire, and does not require a modified guide wire that has a specially-designed fitting or stop to accomplish the locking function.

Claims

1. An embolic protection device that locks to any point along a guide wire, comprising:

an elongated guide wire core without any stops thereon;

a filter assembly having a proximal end and a distal end, disposed on the guide wire core; and

a locking component disposed at at least one of the ends of the filter assembly, wherein the locking component applies frictional engagement against the guide wire core at any point therealong.

2. The embolic protection device of claim 1, wherein the guide wire locking component includes a heat shrinkable shape memory metal alloy.

3. The embolic protection device of claim 1, wherein the guide wire locking component includes at least one of a threaded engagement and a frictional engagement.

4. The embolic protection device of claim 1, wherein the guide wire locking component includes a thrust bearing.

5. The embolic protection device of claim 1, wherein the guide wire locking component includes a heat shrinkable shape memory polymer.

6. The embolic protection device of claim 1, wherein the guide wire core includes a distal coil and the locking component includes a locking coil at least partially overlying the distal coil such that turns of the coils interlace and engage.

7. An embolic protection system for use in a patient, comprising:

a guide wire having a core without stops;

a filter assembly having a first end and a second end; and

a locking component disposed on at least one of the ends of the filter assembly, the locking component having an expanded state and a contracted state;

wherein the locking component locks on the guide wire core when the locking component is transformed from the expanded state to the contracted state.

8. The embolic protection system of claim 7, wherein the locking component includes a shape memory polymer.

9. The embolic protection system of claim 8, wherein the locking component includes a high glass temperature polymer and a low glass temperature polymer.

10. The embolic protection system of claim 7, wherein the locking component includes a heat shrink polymer.

11. The embolic protection system of claim 7, wherein the locking component includes a shrinkable polymer triggered by acidity change.

12. The embolic protection system of claim 7, wherein the locking component includes a shape memory nickel-titanium alloy having an austenitic contracted state and a martensitic expanded state.

13. The embolic protection system of claim 12, wherein a transition temperature of the shape memory nickel-titanium alloy is set to about body temperature of the patient.

14. An embolic protection system, comprising:

a guide wire having a core;

a filter assembly disposed for travel along the guide wire core, the filter assembly having a first end and a second end; and

a shape memory tube disposed on at least one of the ends of the filter assembly, and the shape memory tube having an expanded state and a contracted state;

wherein the shape memory tube constricts onto the guide wire core when the shape memory tube transitions from the martensitic state to the austenitic state.

15. The apparatus of claim 14, wherein the shape memory tube includes a nickel-titanium alloy.

16. The apparatus of claim 14, wherein the shape memory tube includes a transformation temperature of about 37 degrees C.

17. The apparatus of claim 14, wherein the guide wire core does not include a stop for engaging the filter assembly.

23. The apparatus of claim 14, wherein the elongated wire does not include a stop to facilitate securing the object.

18. A locking component for securing an intraluminal medical device onto an elongated wire, comprising:

a tubular body including a shape memory material having a first end and a second end, wherein the tubular body is slidably positioned along the elongated wire, and the first end being attached to the device that is to be secured along the elongated wire, and the second end grips the elongated wire when tubular body is transformed from an expanded state to a contracted state.

19. The locking component of claim 18, wherein the tubular body includes a heat shrink polymer.

20. The locking component of claim 18, wherein the tubular body member includes a high glass temperature polymer and a low glass temperature polymer.

21. The locking component of claim 18, wherein the tubular body member includes a shape memory nickel-titanium alloy.

22. The locking component of claim 21, wherein the shape memory nickel-titanium alloy has a recovery temperature set to body temperature.

24. An embolic protection system wherein the guide wire is pre-deployed into a lumen, comprising:

a guide wire having an elongated core without stops;

a filter assembly disposed on the guide wire for movement along the elongated core, the filter assembly having a first end and a second end; and

a locking device attached to at least one of the ends of the filter assembly, the locking device having an unlocked position for moving the filter assembly into a desired position on the pre-deployed guide wire within the lumen, and a locked position for securing the filter assembly onto the guide wire.

25. The embolic protection system of claim 24, wherein the locking device includes an interlocking bushing having a first and a second end and a frame bushing having a tapered inner diameter, the second end of the interlocking bushing is disposed adjacent to the frame bushing, and the locking device is in the locked position when the second end of the interlocking bushing is fitted inside the tapered inner diameter of the frame bushing.

26. The embolic protection system of claim 25, further including a delivery sheath enclosing the filter assembly.

27. The embolic protection system of claim 26, further including a floating hypotube disposed between the guide wire and the delivery sheath, wherein the hypotube abuts the interlocking bushing and frictionally fits the second end of the interlocking bushing into the tapered diameter of the frame bushing.

28. The embolic protection system of claim 24, further including a clawed hypotube disposed over the guide wire, wherein the clawed hypotube grasps onto the first end of the filter assembly to further secure the filter assembly onto the guide wire.

29. A method for locking a filter assembly to a guide wire, comprising:

inserting the guide wire having an elongated core with no stops into a body lumen and directing a distal end of the guide wire to a treatment area;

slidably mounting the filter assembly having first and second ends and including a guide wire locking component disposed on at least one end onto the guide wire, and advancing the filter assembly along the guide wire; and

locking the guide wire locking component to the elongated core of the guide wire.

30. The method of claim 29, further comprising placing a delivery sheath over the filter assembly to maintain the filter assembly in a collapsed position, and advancing the delivery sheath including the filter assembly over the guide wire.

31. The method of claim 30, wherein the guide wire locking component includes an interlocking bushing having a first and a second end and a frame bushing having a tapered inner diameter, and the second end of the interlocking bushing is disposed adjacent to the frame bushing.

32. The method of claim 31, further comprising pushing a hypotube disposed over the guide wire against the first end of the interlocking bushing to fit the second end of the interlocking bushing inside the tapered inner diameter of the frame bushing.

33. The method of claim 32, further comprising retracting the delivery sheath from the filter assembly to expose the filter assembly after locking the filter assembly to the guide wire, allowing the filter assembly to transform to an expanded position.

34. The method of claim 33, further comprising removing the hypotube from the body lumen.

35. The method of claim 29, further comprising advancing a clawed hypotube over the guide wire to grasp the first end of the filter assembly, advancing a recovery sheath over the filter assembly, and removing the guide wire, clawed hypotube, and recovery sheath from the body lumen.

36. A locking component for securing a medical device to an elongated wire, comprising:

a frame bushing having a tapered inner diameter, wherein the frame bushing is attached to the medical device and disposed for travel along the elongated wire;

an interlocking bushing having a first and second end, wherein the first end is slidably disposed within the tapered inner diameter of the frame bushing, and the interlocking bushing is disposed for travel along the elongated wire; and

wherein the medical device is secured to the elongated wire when the first end of the interlocking bushing is pushed along the tapered inner diameter of the frame bushing.

37. The locking component of claim 36, wherein the frame bushing includes a groove formed at an end of the tapered inner diameter, and the first end of the interlocking bushing includes a ridge that locks into the groove when the interlocking bushing is pushed along the tapered inner diameter of the frame bushing.

38. An embolic protection system, comprising:

a guide wire having an elongated core without stops;

a filter assembly disposed on the guide wire for movement along the elongated core, the filter assembly having a first end and a second end;

a self-contracting elastic tube having a free end and an opposite end extending from at least one of the ends of the filter assembly, the elastic tube having a contracted state for gripping onto the guide wire; and

a hypotube disposed over the guide wire on to which is mounted the elastic tube, wherein translation of the hypotube relative to the elastic tube dismounts the elastic tube to transition into the contracted state.

39. The apparatus of claim 38, wherein the free end of the elastic tube is removably mounted onto the hypotube.

40. The apparatus of claim 38, wherein the self-contracting elastic tube includes an elastic and lubricious polymer.

41. A method for locking a medical device to a guide wire, comprising:

inserting a guide wire having an elongated core into the blood vessel and advancing the distal end of the guide wire to a treatment area;

slidably mounting a filter assembly having first and second ends to the guide wire;

providing a hypotube disposed over the elongated core;

mounting a self-contracting elastic tube over the hypotube and disposing the elastic tube on the filter assembly;

advancing the filter assembly along the elongated core; and

translating the hypotube relative to the elastic tube wherein the elastic tube at least partially dismounts and contracts onto the elongated core.

42. The method of claim 41, further comprising bonding one end of the elastic tube to the filter assembly and translating the hypotube to allow a free end of the elastic tube to self-contract.

43. The method of claim 42, wherein the elastic tube is stretched over the hypotube.

44. An embolic protection system, comprising:

a guide wire having an elongated core without stops;

a filter assembly disposed for movement along the guide wire core, the filter assembly having a first end and a second end; and

a locking device projecting from at least one of the filter assembly ends, wherein the locking device includes a thrust bearing that allows free movement of the filter assembly in one direction and locks to the elongated core to prevent movement of the filter assembly in the opposite direction.

45. The embolic protection system of claim 44, wherein the thrust bearing includes a housing having a tapered interior diametrical profile, and a roller is positioned inside the housing that wedges against the guide wire when the roller is forced along the tapered interior diametrical profile of the housing from a greater diameter to a lesser diameter.

46. The embolic protection system of claim 44, wherein a first locking device is disposed on the first end of the filter assembly and a second locking device is disposed on the second end of the filter assembly, wherein the first and second locking devices prevent movement in opposite directions.

47. The embolic protection system of claim 44, further comprising a hypotube disposed on the filter assembly, wherein the hypotube engages the roller to prevent the roller from moving in one direction along the tapered interior diametrical profile of the housing.

48. A locking component for securing a medical device to an elongated wire, comprising:

a housing including a tapered interior diametrical profile and a roller positioned inside the housing that is moveable along the tapered interior diametrical profile, wherein the roller compresses against the guide wire when the roller is forced along the tapered interior diametrical profile of the housing from a greater diameter to a lesser diameter.

49. The locking component of claim 48, wherein the inner diameter of the housing includes a first portion having a constant diameter and a second portion having a tapered interior diametrical profile.

50. The locking component of claim 49, further comprising a spring having a first end and a second end, wherein the spring is disposed inside the first portion of the housing and the first end abuts an inside wall of the housing and the second end abuts the roller, wherein the spring biases the roller towards the tapered interior diameter of the housing.

51. The locking component of claim 48, wherein the roller includes at least two ball bearings held together with a circular thrust plate.

52. An embolic protection system, comprising:

a guide wire having an elongated core without stops;

a filter assembly disposed on the guide wire, the filter assembly having a first end and a second end; and

an interlocking mechanism attached to at least one of the ends of the filter assembly, the interlocking mechanism having a housing including a gripping member having an expanded state and a contracted state, and having a cap that engages the housing;

wherein the filter assembly is locked onto the guide wire core by engaging the cap with the housing to transform the gripping member from the expanded state to the contracted state.

53. The embolic protection system of claim 52, wherein the filter assembly includes a an inner housing connected to the first end and the second end, a frame having a contracted state and expanded state connected to the inner housing, and a filter attached to the frame.

54. The apparatus of claim 52, wherein the gripping member includes a collet, and the cap includes a tapered inner diameter that forces the collet into the contracted state when the cap engages the housing.

55. The apparatus of claim 52, wherein the gripping member includes an o-ring, and the cap having a longitudinal axis includes an internal surface oriented perpendicularly to the longitudinal axis that compresses the o-ring into the contracted state when the cap engages the housing.

56. The apparatus of claim 52, wherein the housing includes threads and the cap includes complementary threads.

57. An embolic protection system, comprising:

a guide wire having an elongated core with a proximal end and a distal end, and a coil disposed at the distal end of the core;

a filter assembly disposed for travel along the elongated core, the filter assembly having a first end and a second end; and

a self-contracting locking component having an attached end and a free end, wherein the attached end is attached to one of the ends of the filter assembly; and

a hypotube on which is mounted at least the free end of the locking component and slidably disposed on the elongated core;

wherein the free end of the locking component self-contracts onto the coil when the hypotube withdraws from underneath to dismount the free end of the locking component.

58. The apparatus of claim 57, wherein the locking component includes a coil.

59. The apparatus of claim 57, wherein the locking component includes a nickel-titanium alloy.

60. The apparatus of claim 57, wherein the hypotube includes a laser cut opening.

61. The apparatus of claim 57, wherein the elongated core of the guide wire does not include any stops.

62. A method for locking a medical device to a guide wire, comprising:

inserting a guide wire having an elongated core with proximal and distal ends and a coil disposed a the distal end of the guide wire into a blood vessel and advancing the distal end to a treatment area;

slidably mounting a filter assembly having a first end and a second end onto the guide wire, and advancing the filter assembly to the distal end of the guide wire; and

contracting a locking coil attached to one of the ends of the filter assembly onto the guide wire coil.

63. The method of claim 62, wherein contracting a locking coil onto the guide wire coil includes withdrawing a hypotube from underneath the locking coil which is expanded over the hypotube when the coil is positioned over a portion of the guide wire coil.

64. The method of claim 62, wherein the elongated core does not include a stop.

65. A method for locking a medical device to a guide wire, comprising:

inserting a guide wire having an elongated core with proximal and distal ends and a coil disposed at the distal end of the elongated core into a body lumen;

advancing the distal end of the elongated core to a treatment area;

slidably mounting a filter assembly onto the guide wire, the filter assembly having a first end and a second end with a self-contracting locking coil attached to the second end;

advancing the filter assembly to the distal end of the guide wire; and

translating the locking coil onto the guide wire coil, thereby locking the filter assembly onto the distal end of the guide wire.

66. The method of claim 65, wherein translating the locking coil onto the guide wire coil includes translating the locking coil at least partially over a solder bead that attaches the coil to the elongated core.

67. The method of claim 66, wherein the solder bead includes a taper and the locking coil at least partially passes over the taper.