Steerable device having a corewire within a tube and combination with a functional medical component

• US 20050209631A1
• Filed: 11/02/2004
• Published: 09/22/2005
• Est. Priority Date: 03/06/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Galdonik, Jason A., Ogle, Matthew F., Pokorney, James
• Granted Patent: US 7,988,705 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/09016 with mandrils
• CPC Class Codes: A61M 25/09025 with sliding mandrils

Abstract

An integrated guiding device has a tube and a corewire within the tube and a torque coupler. The torque coupler can couple the rotational motion of the tube with the rotational motion of the corewire. The wire can be moved longitudinally at least some amount relative to the tube. The device can further comprise a functional medical structure, such as an embolism protection structure. The device can be used in medical procedures, such as less invasive procedures within the cardiovascular system. Improved fiber based embolism protection devices comprise fiber bundles that are twisted prior to delivery.

Claims

1. A biocompatible integrated guiding device comprising a tube with an internal lumen, a corewire within the lumen of the tube, and a torque coupler that can couple the rotational motion of the tube with the rotational motion of the corewire wherein the corewire can be moved longitudinally at least some amount within the lumen of the tube.

2. The biocompatible integrated guiding device of claim 1 wherein the tube comprises a key way within the lumen having a surface with an asymmetrical cross section and the corewire comprises a key having a surface with an asymmetrical cross section complimentary to the asymmetrical cross section of the key way surface.

3. The biocompatible integrated guiding device of claim 2 wherein the key way extends over the entire length of the tube.

4. The biocompatible integrated guiding device of claim 2 wherein the key way extends over only a portion of the length of the tube.

5. The biocompatible integrated guiding device of claim 4 wherein the key way comprises a notch and the key comprises an indentation with the notch of the key way lining up within the indentation of the key and the longitudinal motion of the corewire being limited by the constraint that the notch remain within the indentation.

6. The biocompatible integrated guiding device of claim 1 wherein the torque coupler is engaged at some longitudinal positions of the corewire and the tube and is not engaged at other longitudinal positions of the corewire and the tube.

7. The biocompatible integrated guiding device of claim 6 further comprising an actuation element that automatically rotates the corewire relative to the tube during a portion of a longitudinal movement of the corewire relative to the tube.

8. The biocompatible integrated guiding device of claim 1 wherein the torque coupler is located within 20 centimeters of the distal end of the corewire.

9. The biocompatible integrated guiding device of claim 1 wherein the torque coupler comprises a coil attached to the tube that grips the corewire upon the application of appropriate torque to the tube.

10. The biocompatible integrated guiding device of claim 1 wherein the torque coupler comprises a compressible section that rotationally couples the tube and the corewire when compressed.

11. The biocompatible integrated guiding device of claim 1 wherein the torque coupler comprises threads on the corewire and mated threads on the tube that can be selectively engaged.

12. The biocompatible integrated guiding device of claim 1 wherein the torque coupler comprises two interconnecting elements that can be selectively engaged through longitudinal motion to rotationally couple the corewire and the tube.

13. The biocompatible integrated guiding device of claim 1 wherein the torque coupler comprises an electrostatic attractive elements.

14. The biocompatible integrated guiding device of claim 1 wherein the torque coupler is always engaged once it is formed.

15. The biocompatible integrated guiding device of claim 1 wherein the torque coupler can be selectively engaged and disengaged.

16. The biocompatible integrated guiding device of claim 1 wherein the tube and corewire comprise stainless steel.

17. The biocompatible integrated guiding device of claim 1 further comprising a functional medical structure.

18. The biocompatible integrated guiding device of claim 17 wherein the functional medical structure comprises a gripper.

19. The biocompatible integrated guiding device of claim 17 wherein the functional medical structure comprises a fastener applicator.

20. The biocompatible integrated guiding device of claim 17 wherein the functional medical structure comprises an embolism protection device.

21. The biocompatible integrated guiding device of claim 20 wherein the embolism protection device comprises fibers.

22. The biocompatible integrated guiding device of claim 21 wherein the fibers are generally aligned within a bundle with one end of the bundle being fastened to the tube and one end of the bundle being fastened to the corewire and wherein longitudinal motion of the corewire relative to the tube actuates or de-actuates the embolism protection device.

23. The biocompatible integrated guiding device of claim 1 further comprising a coil at the distal end of the tube.

24. The biocompatible integrated guiding device of claim 1 further comprising a coil at the distal end of the corewire.

25. A method for selectively placing a corewire within a patient, the method comprising inserting a biocompatible integrated guiding device of claim 1 into the patient through an incision and directing the corewire to a desired location within the patient.

26. The method of claim 25 wherein the incision is within a patient'"'"'s thigh, arm or neck.

27. The method of claim 25 wherein the desired location is within the patient'"'"'s arterial vasculature.

28. The method of claim 25 further comprising rotating the tube to rotate the distal end of the corewire through the rotational coupling of the torque coupler.

29. The method of claim 25 wherein the integrated guiding device further comprises a functional medical structure and the method further comprises activating the functional medical structure through the relative longitudinal movement of the tube and the corewire.

30. A method for guiding a medical device having a corewire within the lumen of a tube and a torque coupler that rotationally couple the tube and the corewire, the method comprising engaging an element of the torque coupler associated with the corewire with an element of the torque coupler associated with the tube.

31. The method of claim 30 wherein the engaging of the torque coupler comprises inserting the corewire within the tube.

32. The method of claim 30 wherein the engaging of the torque coupler comprises deforming a portion of the tube to form a key way.

33. The method of claim 32 wherein the corewire comprises a flat portion and wherein the deforming of the tube comprises forming a notch in the tube adjacent the flat portion of the corewire.

34. The method of claim 30 wherein the torque coupler remains engaged as long as the corewire is within the tube without the application of any additional forces.

35. The method of claim 30 wherein the corewire can move longitudinally with respect to the tube after the torque coupler is engaged.

36. The method of claim 30 wherein the corewire can move longitudinally with respect to the tube before the torque coupler is engaged and wherein the torque coupler become disengaged when no forces are applied to torque coupler.

37. An embolism protection device comprising a corewire and a bundle of fibers fastened together at a first end that is free to move relative to the corewire and fastened collectively to the corewire at a second end wherein the bundle of fibers have a configuration with the fibers being generally aligned and wherein the respective ends of the fiber bundle are twisted relative to each other about an axis aligned along the corewire.

38. The embolism protection device of claim 37 wherein the fibers comprise polymeric surface capillary fibers.

39. The embolism protection device of claim 38 wherein the surface capillary fibers comprise polyester.

40. The embolism protection device of claim 37 further comprising a fiber support wherein the fiber support comprises an adhesive that secures the fibers.

41. The embolism protection device of claim 37 further comprising a fiber support that comprises a first element attached to one end of the fibers and a second element attached to the other end of the fibers.

42. The embolism protection device of claim 41 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 an actuating element controls transition of the fiber support between the first configuration and the second configuration 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.

43. The embolism protection device of claim 42 wherein the first element is generally cylindrical with a central passage and wherein the actuating element comprises a corewire that passes through the central passage and that is attached to the second element wherein movement of the corewire within the central passage away from the second element moves the fiber support from the first configuration to the second configuration.

44. The embolism protection device of claim 43 wherein the first element is connected to a tube with a central lumen and the corewire passes through the central lumen and extends from the proximal end of the central passage.

45. The embolism protection device of claim 44 wherein the fiber support structure comprises a radio-opaque element.

46. The embolism protection device of claim 44 further comprising a torque coupler that can couple the rotational motion of the tube with the rotational motion of the corewire.

47. The embolism protection device of claim 46 wherein the torque coupler is engaged at some longitudinal positions of the corewire and the tube and not engaged at other positions of the corewire and the tube.

48. The embolism protection device of claim 47 further comprising an actuation element that automatically rotates the corewire relative to the tube over a portion of the longitudinal motion of the corewire relative to the tube.

49. The embolism protection device of claim 41 wherein the fiber support structure comprises a metal band that encircles a bundle of fibers near the fiber ends to secure the fibers.

50. The embolism protection device of claim 37 wherein the device has a first configuration that can pass through a catheter with an appropriate size to enter a human vessel.

51. The embolism protection device of claim 50 wherein the device has a second configuration having the center of the fibers flaring outward from the ends at a sufficient distance to fill the lumen of a human vessel.

52. The embolism protection device of claim 37 wherein the device comprises from about 50 to about 5000 fibers.

53. The embolism protection device of claim 37 wherein the device comprises fibers with a size from about 0.5 denier to about 25 denier.

54. The embolism protection device of claim 37 wherein the fibers comprise surface capillary fibers with a specific capillary volume of at least about 0.5 cc/g.

55. The embolism protection device of claim 37 wherein the first end is twisted by at least about 5 degrees relative to the second end.

56. The embolism protection device of claim 37 wherein the ends of the fiber bundle are twisted in a configuration in which the fibers are generally aligned.

57. The embolism protection device of claim 37 wherein the ends of the fiber bundle are twisted in a configuration in which the fibers are flared in a deployed configuration.