Elongate medical device with distal cap

• US 20040167436A1
• Filed: 02/26/2003
• Published: 08/26/2004
• Est. Priority Date: 02/26/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Eskuri, Alan D., Skujins, Peter, Johnson, Dave, Reynolds, Brian R.
• Granted Patent: US 7,169,118 B2
• Time in Patent Office: Days
• US Class Current: 600/585
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

Elongate medical devices such as guidewires can be formed from a core wire and a preformed distal cap that is configured to fit over a distal end of the core wire. The distal cap can be attached using a variety of techniques. In particular, the distal cap can be attached to the core wire using laser welding.

Claims

1. An elongate medical device comprising:

an elongate shaft having a distal end and a proximal end; and

a distal cap that is formed independently of the elongate shaft, the distal cap having a distal end and a proximal end, the proximal end of the distal cap comprising an aperture configured to accept the distal end of the elongate shaft;

wherein the distal cap, once formed, is secured to the distal end of the elongate shaft.

2. The elongate medical device of claim 1, wherein the distal cap is secured to the distal end of the elongate shaft via welding.

3. The elongate medical device of claim 2, wherein the distal cap is laser welded or plasma welded to the distal end of the elongate shaft.

4. The elongate medical device of claim 1, wherein the distal cap comprises a metallic material that is welding-compatible with the elongate shaft, also comprising a metallic material.

5. The elongate medical device of claim 1, wherein the proximal end of the distal cap has a substantially cylindrical outer profile and an inner profile that mirrors an outer profile of the distal end of the elongate shaft.

6. The elongate medical device of claim 1, wherein the distal end of the distal cap is adapted and configured to provide an atraumatic tip to the elongate medical device.

7. The elongate medical device of claim 1, wherein the proximal end of the distal cap has a hemispherical profile.

8. The elongate medical device of claim 1, wherein the proximal end of the distal cap is adapted and configured to fit tightly over the distal end of the elongate shaft.

9. The elongate medical device of claim 1, further comprising a distal sleeve positioned between the distal end of the elongate shaft and an inner surface of the distal cap.

10. The elongate medical device of claim 9, wherein the distal sleeve is secured to the distal end of the elongate shaft and the distal cap is secured to the distal sleeve.

11. The elongate medical device of claim 9, wherein the distal sleeve is secured to the distal end of the elongate shaft and the distal cap is secured to the distal sleeve via either laser welding or plasma welding.

12. The elongate medical device of claim 9, wherein the distal cap comprises a metallic material that is welding-compatible with the distal sleeve and the elongate shaft, each of which also comprise a metallic material.

13. The elongate medical device of claim 1, wherein the elongate medical device comprises a guidewire.

14. A guidewire produced by a process of:

providing a core wire having a distal end and a proximal end;

forming a distal cap having a distal end and a proximal end, the proximal end of the distal cap comprising an aperture configured to accept the distal end of the core wire;

positioning the distal cap over the distal end of the core wire by inserting the distal end of the core wire into the distal cap lumen; and

thereafter welding the distal cap to the distal end of the core wire.

15. The guidewire of claim 14, wherein welding the distal cap comprises laser welding or plasma welding.

16. The guidewire of claim 14, wherein the distal cap comprises a metallic material that is welding-compatible with the core wire, also comprising a metallic material.

17. The guidewire of claim 14, further comprising a distal sleeve that has been positioned between the distal end of the elongate shaft and an inner surface of the distal cap.

18. The guidewire of claim 17, wherein the distal sleeve is secured to the distal end of the core wire and the distal cap is secured to the distal sleeve via either laser welding or plasma welding.

19. The guidewire of claim 14, further comprising a coil having a distal end and a proximal end, where the distal end of the coil is positioned proximate the distal portion of the core wire.

20. The guidewire of claim 19, wherein the distal end of the coil extends distally to a position proximal of the distal end of the core wire, and the proximal end of the distal cap extends proximally to the same position.

21. The guidewire of claim 20, wherein the distal cap, the distal end of the coil and the distal end of the core wire are attached via welding.

22. The guidewire of claim 21, wherein the distal cap, the coil and the core wire are all formed of welding-compatible metallic materials.

23. A guidewire comprising:

a core wire having a distal end and a proximal end; and

a distal cap having a distal end and a proximal end, the proximal end of the distal cap comprising an aperture adapted to accept the distal end of the core wire;

wherein the distal cap is formed independently of the core wire and is subsequently attached to the distal end of the core wire.

24. The guidewire of claim 23, wherein the distal cap is laser welded or plasma welded to the distal end of the core wire.

25. The guidewire of claim 24, wherein the distal cap and the core wire are formed of welding-compatible metallic materials.

26. The guidewire of claim 24, wherein the distal cap is formed by one of deep drawing, roll forming or stamping.

27. The guidewire of claim 23, wherein the proximal end of the distal cap has a substantially cylindrical outer profile and an inner profile that mirrors an outer profile of the distal end of the core wire.

28. The guidewire of claim 23, wherein the distal end of the distal cap is adapted and configured to provide an atraumatic tip to the guidewire.

29. The guidewire of claim 23, wherein the proximal end of the distal cap has a hemispherical profile.

30. The guidewire of claim 23, wherein the proximal end of the distal cap is adapted and configured to fit tightly over the distal end of the core wire.

31. The guidewire of claim 23, further comprising a distal sleeve positioned between the distal end of the core wire and an inner surface of the distal cap.

32. The guidewire of claim 31, wherein the distal sleeve is secured to the distal end of the core wire and the distal cap is secured to the distal sleeve.

33. The guidewire of claim 32, wherein the distal sleeve is secured to the distal end of the core wire and the distal cap is secured to the distal sleeve via either laser welding or plasma welding.

34. The guidewire of claim 32, wherein the distal sleeve is formed of a metallic material that is welding-compatible with the core wire and the distal cap.

35. The guidewire of claim 23, wherein the core wire comprises a proximal portion having a first diameter, an intermediate portion having a second diameter that is less than the first diameter, and a distal portion having a diameter that is less than the second diameter.

36. The guidewire of claim 35, further comprising a proximal transition region positioned between the proximal portion and the intermediate portion and a distal transition region positioned between the intermediate portion and the distal portion.

37. The guidewire of claim 35, further comprising a coil having a distal end and a proximal end.

38. The guidewire of claim 37, wherein the proximal end of the coil is positioned proximate the proximal transition region and the distal end of the coil is positioned proximate the distal portion of the core wire.

39. The guidewire of claim 37, wherein the proximal end of the coil is positioned proximate the distal transition region and the distal end of the coil is positioned proximate the distal portion of the core wire.

40. The guidewire of claim 39, further comprising a polymeric sleeve positioned over the coil, extending from the proximal transition region to a position proximate the distal portion of the core wire.

41. The guidewire of claim 37, wherein the distal end of the coil extends distally to a position proximal of the distal end of the core wire, and the proximal end of the distal cap extends proximally to the same position.

42. The guidewire of claim 41, wherein the distal cap, the distal end of the coil and the distal end of the core wire are attached via welding.

43. The guidewire of claim 35, wherein the core wire further comprises a distal heat sink portion that is positioned distal of the distal portion and that has a diameter that is greater than that of the distal portion.

44. The guidewire of claim 43, wherein the proximal end of the distal cap is adapted and configured to fit tightly over a distal end of the distal heat sink portion and extends proximally to an intermediate position on the distal heat sink portion, and the coil extends distally to the same intermediate position.

45. A method of producing a guidewire, comprising:

providing a core wire having a distal end and a proximal end;

providing a distal cap having a distal end and a proximal end, the proximal end of the distal cap comprising an aperture configured to fit over the distal end of the core wire;

inserting the distal end of the core wire into the distal cap aperture; and

attaching the distal cap over the distal end of the core wire.

46. The method of claim 45, wherein welding the distal cap comprises laser welding or plasma welding.

47. The method of claim 45, wherein the distal cap comprises a metallic material that is welding-compatible with the core wire, also comprising a metallic material.

48. The method of claim 45, further comprising positioning a distal sleeve between the distal end of the core wire and an inner surface of the distal cap.

49. The method of claim 48, wherein the distal sleeve is secured to the distal end of the core wire and the distal cap is secured to the distal sleeve via either laser welding or plasma welding.

50. The guidewire of claim 45, further comprising positioning a coil having a distal end and a proximal end, where the distal end of the coil is positioned proximate the distal portion of the core wire.

51. The guidewire of claim 50, wherein the distal end of the coil extends distally to a position proximal of the distal end of the core wire, and the proximal end of the distal cap extends proximally to the same position.

52. The guidewire of claim 51, wherein the distal cap, the distal end of the coil and the distal end of the core wire are attached via welding.

53. The guidewire of claim 52, wherein the distal cap, the coil and the core wire are all formed of welding-compatible metallic materials.

54. The method of claim 45, wherein the distal cap is formed via injection molding.

55. The method of claim 54, wherein securing the distal cap over the distal end of the core wire comprises melting at least part of the distal cap via laser or plasma welding.

56. A method of producing a guidewire, comprising:

providing a core wire having a distal end and a proximal end;

providing a tubular sleeve having a distal end and a proximal end;

positioning the tubular sleeve over the distal end of the core wire;

positioning a metal ball proximate the distal end of the tubular sleeve; and

melting at least a portion of the tubular sleeve and the metal ball via laser or plasma welding to form an atraumatic tip.

57. The method of claim 56, wherein the metal ball and the tubular sleeve are formed of metallic materials that are welding-compatible with the core wire.

58. The method of claim 56, further comprising positioning a coil over the distal end of the core wire prior to melting the tubular sleeve and the metal ball.

59. A guidewire comprising:

a core wire having a distal end and a proximal end;

a distal cap having a distal end and a proximal end, the proximal end including a tubular structure defining a lumen configured to fit over the distal end of the core wire, the distal end defining an arcuate atraumatic surface;

wherein the distal cap is formed independently of the core wire, and is subsequently attached to the distal end of the core wire by inserting the distal end of the core wire into the lumen and welding the distal cap to the core wire.

60. A guidewire comprising:

a core wire having a distal end and a proximal end; and

means of forming a distal tip, said means formed independently and then subsequently secured to the distal end of the core wire.

61. A method of manufacturing a medical device, comprising the steps of:

providing a core wire having a proximal section and a distal section defining a distal end;

providing a tubular body member having a proximal portion and a distal portion;

attaching a tip to the distal portion of the tubular member to form a distal cap member comprising the tubular body member and the tip; and

coupling the proximal portion of the tubular body to the distal end.