METHODS AND DEVICES FOR CRIMPING SELF-EXPANDING DEVICES

• US 20100043197A1
• Filed: 07/30/2009
• Published: 02/25/2010
• Est. Priority Date: 08/01/2008
• Status: Active Grant

• Current Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Original Assignee: Intersect ENT, Inc. (Medtronic Plc)
• Inventors: Rajasekhar, Vijaykumar, Gale, David C., Huang, Bin, ABBATE, Anthony J., Zaler, Gail M., Kaufman, Richard E.
• Granted Patent: US 8,763,222 B2
• Time in Patent Office: Days
• US Class Current: 29/505
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: B25B 27/10 inserting fittings into hoses
• CPC Class Codes: Y10T 29/49908 Joining by deforming
• CPC Class Codes: Y10T 29/53657 to apply or remove a resilient article [e.g., tube, sleeve, etc.]
• CPC Class Codes: Y10T 29/53709 Overedge assembling means
• CPC Class Codes: Y10T 29/53783 Clip applier
• CPC Class Codes: Y10T 29/53991 Work gripper, anvil, or element

Abstract

Described here are devices and methods for crimping self-expanding devices. The crimping devices may be useful for crimping a variety of different self-expanding devices (whether such devices are biodegradable or bio-durable). The crimping devices may have crimping members to engage the self-expanding device to reduce the device from an expanding configuration to an unexpanded configuration. The crimping member may comprise or include a suture, wire, ribbon, guiding hoop, pusher, prong, holding bar, balloon, jaws, combinations thereof, or the like. The crimping devices may also include or comprise a holding structure to hold the self-expanding device in an unexpanded or expanded configuration.

Claims

1. A crimping device for crimping a self-expanding device having an unexpanded configuration and an expanded configuration, the crimping device comprising:

a crimping member, wherein the crimping member engages the self-expanding device to reduce the self-expanding device to its unexpanded configuration, and wherein the crimping device engages an applicator or storage member to hold the self-expanding device in its unexpanded configuration.

2. The crimping device of claim 1, wherein the self-expanding device is biodegradable.

3. The crimping device of claim 1, wherein the self-expanding device is bio-durable.

4. The crimping device of claim 1, wherein the crimping member comprises a suture, wire, ribbon, guiding hoop, pusher, balloon or a combination thereof.

5. The crimping device of claim 1, wherein the crimping member further comprises one or more handles.

6. The crimping device of claim 1, further comprising a holding structure configured to hold the self-expanding device in its expanded configuration.

7. The crimping device of claim 6, wherein the holding structure defines an aperture.

8. The crimping device of claim 6, wherein the holding structure comprises a hoop.

9. The crimping device of claim 6, wherein the holding structure comprises a rod.

10. The crimping device of claim 9, wherein the rod is tapered.

11. The crimping device of claim 6, wherein the holding structure comprises indents, a sheath, a ring, a wire, a ribbon, a hoop, a pusher, or combination thereof.

12. The crimping device of claim 11, wherein the holding structure comprises a sheath.

13. The crimping device of claim 12, wherein the sheath is slidable.

14. The crimping device of claim 6, wherein the holding structure comprises one or more passage units.

15. The crimping device of claim 6 wherein the holding structure comprises a canister.

16. The crimping device of claim 6, wherein the holding structure comprises one or more tracks.

17. The crimping device of claim 16, wherein the holding structure comprises one or more pins slidably disposed in the one or more tracks.

18. The crimping device of claim 6, wherein the holding structure comprises a funnel.

19. The crimping device of claim 6, wherein the holding structure comprises at least two separate components.

20. A crimping device for crimping a self-expanding device having an unexpanded configuration and an expanded configuration, the crimping device comprising:

a holding structure, the holding structure configured to hold therein the self-expanding device in its expanded configuration; and

a crimping control, wherein movement of the crimping control relative to the holding structure causes the crimping device to reduce the self-expanding device to its unexpanded configuration.

21. The crimping device of claim 20, wherein the self-expanding device is biodegradable.

22. The crimping device of claim 20, wherein the crimping control rotates relative to the holding structure.

23. The crimping device of claim 20, wherein the holding structure comprises at least two separate components that together form the holding structure.

24. The crimping device of claim 20, wherein the holding structure comprises tracks.

25. The crimping device of claim 24, wherein the crimping control comprises tracks.

26. The crimping device of claim 25, wherein the tracks of the holding structure project radially from a center of the holding structure, and wherein the tracks of the crimping control curve radially away from a center of the crimping control.

27. The crimping device of claim 25, further comprising pins that are slidably disposed within the tracks of the crimping control and the tracks of the holding structure.

28. The crimping device of claim 20, wherein the holding structure defines an aperture through which the self-expanding device may be retrieved when the self-expanding device is in its unexpanded configuration.

29. The crimping device of claim 20, further comprising one or more crimping members.

30. The crimping device of claim 29, wherein the holding structure comprises passage units.

31. The crimping device of claim 29, wherein the crimping control engages the one or more crimping members.

32. The crimping device of claim 20, wherein the holding structure comprises a rod.

33. The crimping device of claim 32, wherein the rod is tapered.

34. The crimping device of claim 20, wherein the holding structure comprises indents, a sheath, a ring, a wire, a ribbon, a hoop, a pusher, or combination thereof.

35. The crimping device of claim 34, wherein the holding structure comprises a sheath.

36. The crimping device of claim 35, wherein the sheath is slidable.

37. A crimping device for crimping a self-expanding device having an unexpanded configuration and an expanded configuration, the crimping device comprising:

a crimping portion, the crimping portion having a first end, a second end, an interior surface and a plurality of slits running between the first and second ends, wherein the cross-sectional area of the crimping portion decreases from the second end to the first end, and wherein the interior surface of the crimping portion is configured to house the self-expanding device in its expanded configuration; and

a pusher, wherein the pusher includes a plurality of prongs that engage one or more of the plurality of slits and wherein movement of the pusher from the second end of the crimping portion to the first end of the frame compresses the self-expanding device into its unexpanded configuration.

38. The crimping device of claim 37, wherein the self-expanding device is biodegradable.

39. The crimping device of claim 37, wherein the self-expanding device is bio-durable.

40. The crimping device of claim 37, wherein the crimping portion defines an aperture through which the self-expanding device may be retrieved.

41. The crimping device of claim 37, wherein the crimping device includes a storage zone which is configured to releasably hold the self-expanding device.

42. The crimping device of claim 37, wherein the crimping device is configured for attachment to an applicator for delivery of the self-expanding device.

43. A crimping device for crimping a self-expanding device having an unexpanded configuration and an expanded configuration, the device comprising:

a first plate and a second plate,

wherein the first plate and second plate are slidably engagable to define an aperture, the aperture having a cross-sectional area that changes when the first plate is slid relative to the second plate.

44. The crimping device of claim 43, wherein the self-expanding device is biodegradable.

45. The crimping device of claim 43, wherein the self-expanding device is bio-durable.

46. The crimping device of claim 43, further comprising a third plate.

47. The crimping device of claim 46, wherein the third plate is fixidly attached to the first plate.

48. The crimping device of claim 46, wherein the third plate is slidably engagable with the second plate.

49. The crimping device of claim 43, wherein the aperture has a substantially symmetrical shape.

50. The crimping device of claim 43, wherein the aperture has a substantially diamond shape.

51. A crimping device for holding a crimped self-expanding device having an unexpanded configuration and an expanded configuration, the crimping device comprising:

a crimping portion, the crimping portion configured to reduce the self-expanding device to its unexpanded configuration;

a storage zone, the storage zone configured to house the self-expanding device in its unexpanded configuration; and

an applicator engagement portion, the applicator engagement portion configured to engage a distal end of an applicator.

52. The crimping device of claim 51, wherein the self-expanding device is biodegradable.

53. The crimping device of claim 51, wherein the self-expanding device is bio-durable.

54. The crimping device of claim 51, wherein the crimping device comprises one or more blades.

55. The crimping device of claim 51, wherein the crimping device comprises a funnel.

56. A method for crimping a self-expanding device comprising:

crimping the self-expanding device into an interior of a delivery device using a crimping device.

57. The method of claim 56, wherein the self-expanding device is biodegradable.

58. The method of claim 56, wherein the self-expanding device is bio-durable.

59. The method of claim 56, wherein the crimping device comprises a funnel.

60. The method of claim 56, wherein the crimping device comprises a crimping member.

61. The method of claim 56, wherein the crimping device defines an aperture.

62. A method for crimping a self-expanding device comprising:

crimping the self-expanding device using a crimping device, the crimping device defining an aperture; and

retrieving the crimped self-expanding device through the aperture using a delivery device.

63. The method of claim 62, wherein the self-expanding device is biodegradable.

64. The method of claim 62, wherein the self-expanding device is bio-durable.

65. The method of claim 62, wherein the crimping device comprises a suture, ribbon, guiding hoop, pusher or combination thereof.

66. The method of claim 62, wherein the crimping device comprises one or more handles.

67. The method of claim 62, wherein the crimping device comprises a hoop.

68. The method of claim 62, wherein the crimping device comprises one or more passage units.

69. The method of claim 62, wherein the crimping device comprises a holding structure.

70. The method of claim 62, wherein the crimping device comprises a funnel.

71. A method of using a self-expanding device having an expanded configuration and an unexpanded configuration comprising:

storing the self-expanding device in its expanded configuration;

crimping the self-expanding device to its unexpanded configuration immediately prior to use; and

delivering the self-expanding device at an anatomical location.

72. The method of claim 71, wherein the self-expanding device is biodegradable.

73. The method of claim 71, wherein the self-expanding device is bio-durable.

74. The method of claim 71, wherein storing the self-expanding device in its expanded configuration comprises storing the self-expanding device in a protective container.