Steerable stylet

• US 6,652,491 B1
• Filed: 05/03/2001
• Issued: 11/25/2003
• Est. Priority Date: 05/03/2001
• Status: Expired due to Fees

• Current Assignee: Catheter Research Incorporated
• Original Assignee: Catheter Research Incorporated
• Inventors: Walker, Gregory L., Steen, John A.
• Primary Examiner(s): Lazarus, Ira S.
• Assistant Examiner(s): Ragonese, Andrea M.
• Application Number:
  US09/848,745
• Time in Patent Office: 936 Days
• Field of Search: 604/19-21, 604/27, 604/36, 604/48, 604/506-510, 604/93.01, 604/164-1-1, 604/170.01, 604/170.02, 604/264, 604/523-528, 604/530-536
• US Class Current: 604/164.01
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0158 with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials

Abstract

A medical device is provided that includes a catheter and a stylet positioned in the catheter. The stylet is configured to guide the catheter through a passage of a patient. The stylet is preferable tubular and made of a shape-memory material that changes shape when heated to bend or turn the catheter.

Claims

1. A device comprising

a flexible, elongated tubular member having a central axis extending therethrough and

a stylet having a shape-memory tube made of shape-memory material and formed to include a lumen extending therethrough, the shape-memory tube being positioned in the tubular member to permit movement of the shape-memory tube relative to the tubular member along the central axis, the movement of the shape-memory tube relative to the tubular member along the central axis occurring during insertion or removal of the stylet into or out of the tubular member during a medical procedure.

2. The device of claim 1, wherein the shape-memory tube is configured to move between an activated position and a deactivated position.

3. The device of claim 1, wherein the tubular member includes a distal end and a proximal end and the shape-memory tube terminates short of the proximal end of the tubular member.

4. The device of claim 1, wherein the stylet further includes an electrical conductor positioned in the lumen of the shape-memory tube.

5. The device of claim 1, wherein the stylet further includes a secondary tube coupled to the shape-memory tube, the secondary tube is positioned in the tubular member, and the secondary tube is made of a different material than the shape-memory tube.

6. The device of claim 5, wherein the secondary tube is electrically coupled to the shape-memory tube.

7. The device of claim 5, wherein the secondary tube and the shape-memory tube am coupled together by a splice joint.

8. The device of claim 7, wherein the secondary tube and shape-memory tube overlap.

9. The device of claim 7, wherein the stylet further includes an interconnection member and one of the interconnection member and the secondary and shape-memory tubes overlap.

10. The device of claim 1, wherein the shape-memory tube moves between a first position when at a first temperature and a second position different than the first position when at a second temperature different than the first temperature and the movement of the shape-memory tube causes a distal end of the tubular member to deflect.

11. The device of claim 1, wherein the shape-memory tube has a first stiffness when at a first temperature and a second stiffness that is greater than the first stiffness when a second temperature.

12. The device of claim 1, wherein a proximal end of the shape-memory tube is configured to couple to an electrical coupling.

13. A device comprising

a tubular member having a lumen formed therein and

a shape-memory member having a lumen formed therein, the shape-memory member being received in the lumen of the tubular member and configured for removal from the lumen, the shape-memory member being movable in response to a change in temperature of the shape-memory member, the shape of the tubular member changing upon movement of the shape-memory member.

14. The device of claim 13, wherein the shape-memory member is configured to slide relative to the tubular member during insertion and removal of the shape-memory member from the tubular member.

15. The device of claim 13, wherein the shape-memory member is positioned in a distal end of the tubular member.

16. The device of claim 13, wherein the tubular member has a proximal end and a distal end and the distal end is closed.

17. The device of claim 13, further comprising first and second conductors, wherein the first conductor is coupled to a proximal end of the shape-memory member and the second conductor is coupled to a distal end of the shape-memory member.

18. The device of claim 17, wherein the second conductor is positioned within the shape-memory member.

19. The device of claim 13, further comprising a secondary tube removably received in the lumen of the tubular member and made a different material than the shape-memory member.

20. The device of claim 19, wherein the secondary tube abuts the shape-memory member.

21. The device of claim 19, wherein the secondary tube is electrically coupled to the shape-memory member.

22. The device of claim 19, wherein the secondary tube is coaxial with the shape-memory tube.

23. The device of claim 19, wherein the secondary tube is spliced with the shape-memory member.

24. The device of claim 19, wherein the tubular member is an electrical lead.

25. A device configured to be inserted into a passage, the device comprising

a catheter formed to include a lumen therein and

a stylet insertable into the lumen of the catheter and having a tubular member made of a shape-memory material configured to alter a physical characteristic of the catheter in response to activation of the shape-memory material.

26. The device of claim 25, wherein the catheter is elongated.

27. The device of claim 26, wherein the catheter is flexible.

28. The device of claim 25, wherein the stylet deflects the catheter upon activation of the shape-memory material.

29. The device of claim 25, wherein the stylet changes the stiffness of the catheter upon activation of the shape-memory material.

30. The device of claim 25, wherein the stylet has a first end and a second end spaced apart from the first end and the tubular member terminates short of the first end.

31. The device of claim 30, wherein the stylet further includes a secondary member extending between the tubular member and the first end.

32. The device of claim 31, wherein the stylet further includes means for coupling the secondary member to the tubular member.

33. The device of claim 25, wherein the shape-memory material is temperature activated.

34. The device of claim 31, wherein the shape-memory material changes shape upon activation.

35. The device of claim 31, wherein the shape-memory material changes stiffness upon activation.

36. The device of claim 25, wherein the catheter is electrically conductive.

37. A medical device configured to be inserted into a passage of a patient, the medical device comprising

a flexible, elongated member having a distal end configured to be inserted into a passage of a patient and a proximal end spaced apart from the distal end, the flexible, elongated member including a primary member, a secondary member, and means for coupling the primary member to the secondary member, the primary member having a lumen formed therein and being made of a shape-memory material, the primary member being made of a first material having a first modulus of elasticity, the secondary member being made of a second material having a second modulus of elasticity that is greater than the first modulus of elasticity.

38. The device of claim 37, wherein the secondary member extends between the primary member and the proximal end.

39. The device of claim 37, wherein the flexible, elongated member further includes a central axis that extends through the primary and secondary members.

40. The device of claim 37, wherein the coupling means electrically couples the primary member to the secondary member.

41. The device of claim 37, wherein the coupling means comprises a butt joint.

42. The device of claim 37, wherein the coupling means comprises a splice joint.

43. The device of claim 37, wherein the coupling means comprises a lap joint.

44. The device of claim 37, further comprising a flexible, elongated catheter having a lumen formed therein, the flexible, elongated member being received within the catheter for ready removal, and the primary member being configured to change a physical characteristic of the catheter upon activation of the shape memory material of the primary member.

45. A medical device configured to be inserted into a passage of a patient, the medical device comprising

a flexible elongated catheter having a lumen formed therein, and

a flexible, elongated member having a distal end configured to be inserted into a passage of a patient and a proximal end spaced apart from the distal end, the flexible, elongated member including a primary member and a secondary member coupled to the primary member, the primary member having a lumen formed therein and being made of a shape-memory material, the secondary member being made of an electrically conductive material, the flexible, elongated member being received within the catheter for contemporaneous removal from the catheter and passage of the patient, and the primary member being configured to change a physical characteristic of the catheter upon activation of the shape-memory material of the primary member.

46. The device of claim 45, wherein the secondary member extends between the primary member and the proximal end.

47. The device of claim 45, wherein the flexible, elongated member further includes a central axis that extends through the primary and secondary members.

48. The device of claim 45, wherein the secondary member is electrically coupled to the primary member.

49. The device of claim 45, wherein the primary and secondary members cooperate to define a butt joint therebetween.

50. The device of claim 45, wherein the flexible elongated member further includes a splice configured to couple the primary member to the secondary member.

51. The device of claim 45, wherein the primary and secondary members cooperate to define a lap joint therebetween.

52. The device of claim 45, wherein the secondary member includes a lumen.

53. The device of claim 52, wherein the lumen of the secondary member aligns with the lumen of the primary member.

54. The device of claim 45, wherein the secondary member is solid.

55. A medical device configured to be inserted into a passage of a patient, the medical device comprising

a flexible, elongated member having a distal end configured to be inserted into a passage of a patient and a proximal end spaced apart from the distal end, the flexible, elongated member including a primary member and a secondary member coupled to the primary member, the primary member having a lumen formed therein and being made of a shape-memory material, the secondary member being made of a metallic material, the primary member including a proximal end and a distal end, the secondary member terminating short of the distal end of the primary member.

56. The medical device of claim 55, wherein the proximal end is stepped.

57. The medical device of claim 55, wherein the primary member and the secondary member are coupled together by a weld.