Fiber based embolism protection device

• US 20050085847A1
• Filed: 03/06/2004
• Published: 04/21/2005
• Est. Priority Date: 07/22/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hinnenkamp, Thomas F., Pokorney, Jim, Galdonik, Jason A., Ogle, Matthew F.
• Granted Patent: US 7,879,062 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 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

Improved embolism protection devices comprises fibers that can have one configuration for delivery of the device and a second configuration in which the device is deployed for filtering of flow within a vessel. In some embodiments, the fibers can be connected to a fiber support, which is connected to an actuating element. The actuating element controls the transition from the delivery configuration to the deployed configuration. The embolism protection device can comprise a guidewire. The fibers can be attached at one end to a fiber support structure and at another end to the guidewire. A hypotube can be attached to the proximal end of the fibers while the guidewire is attached at the distal end of the fibers with the guidewire extending within a central channel of the hypotube. The hypotube can be used to guide the delivery of treatment structures, such as a balloon and/or a stent.

Claims

1. An embolism protection device comprising biocompatible fibers, a fiber support connected to the fibers and an actuating element operably connected to the fiber support, wherein the fiber support has a first configuration in which the fibers are confined within a narrow profile configuration and a second configuration in which an end of the fibers is constrained while the center of the fiber is unconstrained with respect to the narrow profile and wherein the actuating element controls transition of the fiber support between the first configuration and the second configuration.

2. The embolism protection device of claim 1 wherein the fibers comprise polymeric surface capillary fibers.

3. The embolism protection device of claim 2 wherein the surface capillary fibers comprise polyester.

4. The embolism protection device of claim 1 wherein the fiber support comprises an adhesive that secures the fibers.

5. The embolism protection device of claim 4 wherein the fibers are approximately coaxial within the secured adhesive.

6. The embolism protection device of claim 1 wherein the fiber support comprises a first element attached to one end of the fibers and a second element attached to the other end of the fibers and wherein the first configuration has the first element in a spaced apart relationship from the second element with the fibers generally straight and the second configuration has the first element and the second element in closer proximity with the center of the fibers forced away from the straight position.

7. The embolism protection device of claim 6 wherein the first element is generally cylindrical with a central passage and wherein the actuating element comprises a wire that passes through the central passage and that is attached to the second element wherein movement of the wire within the central passage away from the second element moves the fiber support from the first configuration to the second configuration.

8. The embolism protection device of claim 7 wherein the first element is connected to a hypotube with a central passage and the wire passes through the central passage and extends from the proximal end of the central passage.

9. The embolism protection device of claim 8 wherein the hypotube has an outer diameter from about 0.04 inches to about 0.009 inches.

10. The embolism protection device of claim 8 wherein the hypotube has an outer diameter of about 0.014 inches.

11. The embolism protection device of claim 8 further comprising a catheter sheath over the hypotube that can selectively cover the fibers.

12. The embolism protection device of claim 8 further comprising a treatment structure over the hypotube.

13. The embolism protection device of claim 12 wherein the treatment structure comprises a balloon or a stent.

14. The embolism protection device of claim 1 wherein the fiber support structure comprises a generally cylindrical polymer element.

15. The embolism protection device of claim 1 wherein the fiber support structure comprises a metal band that encircles a bundle of fibers near the fiber ends to secure the fibers.

16. The embolism protection device of claim 1 wherein the device in the first configuration can pass through a catheter with an appropriate size to enter a human vessel.

17. The embolism protection device of claim 1 wherein the device in the second configuration has the center of the fibers flaring outward from the ends at a sufficient distance to fill the lumen of a human vessel.

18. The embolism protection device of claim 1 wherein the device comprises from about 50 to about 5000 fibers.

19. The embolism protection device of claim 1 wherein the device comprises fibers with a size from about 0.5 denier to about 25 denier.

20. The embolism protection device of claim 1 wherein the fibers have a specific capillary volume of at least about 0.5 cc/g.

21. An embolism protection device comprising a biocompatible surface capillary fiber, a guidewire and a fiber support structure connected to the guidewire, wherein at least one end of the surface capillary fiber is secured to the fiber support and wherein the surface capillary fiber has a configuration to fill a lumen surrounding the attached end of the fiber with the lumen having a diameter corresponding to that of a human vessel.

22. The embolism protection device of claim 21 wherein the surface capillary fiber has a size from about 0.5 deniers to about 50 deniers.

23. The embolism protection device of claim 21 wherein the surface capillary fiber has a diameter from about 1 denier to about 20 deniers.

24. The embolism protection device of claim 21 wherein the surface capillary fiber has a plurality of surface channels.

25. The embolism protection device of claim 21 wherein the fiber is a 4DG™

fiber.

26. The embolism protection device of claim 21 wherein the fiber has a length from about 0.5 mm to about 25 mm.

27. The embolism protection device of claim 21 further comprising additional fibers to have at least 25 fibers total.

28. The embolism protection device of claim 21 further comprising additional fibers to have a total number from 50 fibers to 5000 fibers.

29. The embolism protection device of claim 21 wherein the fiber support structure comprises a first element and a second element wherein the fiber is attached at one end to the first element and at a second end to the second element.

30. The embolism protection device of claim 29 wherein the first element has a generally cylindrical shape and a central channel.

31. The embolism protection device of claim 30 further comprising a plurality of additional surface capillary fibers wherein each fiber is attached at a first end to the first element and at a second end to the second element and wherein the guidewire passes through the central channel of the first element and attaches to the second element.

32. The embolism protection device of claim 31 wherein the surface capillary fibers are attached to the first element and the second element with an orientation in which the support structure has a first configuration with the first element and the second element separated appropriate to have the surface capillary fibers in a generally straight position between the elements to form a bundle with a generally cylindrical orientation with an axis parallel to the and a second configuration with the ends of the fibers pulled generally toward each other and the centers of the fibers bulging outwardly from the generally cylindrical orientation.

33. The embolism protection device of claim 21 wherein the fiber support structure comprises an adhesive.

34. An embolism entrapment system comprising a hypotube having a central lumen, an embolism protection device of claim 21 wherein the guidewire has a diameter appropriate to pass through the central lumen of the hypotube, and a treatment structure suitable for delivery over the hypotube.

35. The embolism entrapment system of claim 34 wherein the treatment structure comprises a balloon or a stent.

36. The embolism protection system of claim 34 further comprising a catheter sheath with an inner diameter suitable for removable placement of the catheter sheath over the hypotube to cover the surface capillary fiber.

37. A method for removing emboli from a patient'"'"'s vessel, the method comprising placing an embolism entrapment device within a vessel of a patient wherein the embolism entrapment device comprises a plurality of fibers attached to a fiber support structure and the fiber support structure is attached to a guidewire, the fibers having a configuration with fibers free to fill the lumen of the vessel.

38. The method of claim 37 wherein the embolism protection device is placed in the vessel upstream from an occlusion.

39. The method of claim 37 wherein the guidewire extends through a catheter with the proximal end outside of the patient.

40. The method of claim 39 wherein the guidewire for the placement of the fiber support structure within the vessel.

41. The method of claim 39 wherein the guidewire is positioned with the support structure and fibers upstream from an occlusion of the vessel.

42. The method of claim 39 wherein a hypotube extends over the guidewire and wherein an occlusion treatment structure is inserted over the hypotube.

43. The method of claim 42 further comprising treating the occlusion with the occlusion treatment structure.

44. The method of claim 42 wherein the occlusion treatment structure comprises a balloon.

45. The method of claim 42 wherein the occlusion treatment structure comprises a stent.

46. An embolism protection system comprising a hypotube having a distal end and a proximal end, an embolism protection device attached at a first end to the distal end of the hypotube, and guidewire attached at a second end of the embolism protection device wherein the guidewire extends through a central channel of the hypotube.

47. The embolism protection system of claim 46 wherein the embolism protection device has a delivery configuration for deployment with a thickness no more than about 0.040 inches and a deployed configuration extending outwardly from the delivery configuration.

48. The embolism protection device of claim 46 wherein the hypotube has a diameter no more than about 0.040 inches.

49. The embolism protection device of claim 46 wherein the hypotube has a diameter no more than about 0.020 inches.

50. The embolism protection device of claim 46 wherein the hypotube has a diameter of about 0.014 inches.

51. The embolism protection device of claim 46 wherein the distal end of the hypotube is tapered.

52. The embolism protection device of claim 51 wherein the distal element comprises a metal coil over the taper.

53. The embolism protection device of claim 46 wherein the guidewire has a diameter of from about 0.003 to about 0.008 inches.

54. The embolism protection device of claim 46 wherein the embolism protection device comprises fibers having at least one secured end and a central portion that is unbound.

55. The embolism protection device of claim 54 wherein the fibers are surface capillary fibers.

56. The embolism protection device of claim 46 wherein the guidewire extends from the proximal end of the hypotube.

57. The embolism protection device of claim 56 wherein movement of the guidewire relative to the hypotube changes the configuration of the embolism protection device.

58. The embolism protection device of claim 57 wherein the embolism protection device comprises fibers that are secured at both ends and wherein translating the guidewire toward the distal end of the hypotube brings the ends of the fibers closer together to force the center of the fibers away from a central axis along the hypotube.

59. A method for forming an embolism protection device, the method comprising fastening a plurality of surface capillary fibers at an attachment location to form a fiber support structure that engages a guidewire with an appropriate diameter to pass within a human patient'"'"'s vessel.

60. The method of claim 59 wherein the surface capillary fibers are attached with an adhesive.

61. The method of claim 59 wherein the surface capillary fibers are attached together with a rigid band.

62. The method of claim 59 wherein the guidewire has a diameter from about 0.010 to about 0.003 inches.

63. The method of claim 59 wherein from 50 fibers to about 2000 fibers are bundled together.

64. The method of claim 59 wherein a second end of the surface capillary fibers are secured together over a tube through which the wire passes.