Two-stage treatment wire

• US 5,782,741 A
• Filed: 11/12/1996
• Issued: 07/21/1998
• Est. Priority Date: 11/12/1996
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Guidant Corporation (Boston Scientific Corporation)
• Inventors: Bueche, Kenneth M., Bradshaw, Anthony J.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US08/746,467
• Time in Patent Office: 616 Days
• Field of Search: 600/1-8, 128/656-659
• US Class Current: 600/3
• CPC Class Codes: A61M 2025/09141 made of shape memory alloys which take a particular shape at a certain temperature
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61N 2005/1025 Wires
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

A treatment wire is provided for the delivery of a treatment to a site within the body that is composed of two stages. This treatment wire includes a single wire drive portion that is optimal for the proximal end of the treatment wire and engages any storage and/or drive mechanism that may be used in storing and/or deploying the treatment wire. The single drive wire is ground at its distal end to a smaller diameter and encased within a tube forming the second stage of the treatment wire. Because the drive wire terminates proximally to the tube, a cavity is formed that can retain the treating substance to be delivered to the patient. Shape-memory/superelastic material is preferably used for the construction of the treatment wire. When such material is used, the distal end of the treatment wire can be heat treated in order to render it more ductile and, therefore, more desirable for use in the tortuous passageways of the body.

Claims

1. A flexible treatment device for treating a selected site within a patient'"'"'s body comprising:

a flexible, predominantly solid, thin elongate wire having an outer diameter, a proximal end and a distal end, the wire having a tapered neck area between the proximal end and the distal end with the outer diameter of the wire being smaller between the neck area and the distal end than between the neck area and the proximal end;

the wire being constructed from approximately 56% nickel and approximately 44% titanium;

a flexible, hollow, elongated tube having a proximal end, a distal end, an outer diameter and an inner diameter with the outer diameter of the tube being substantially the same as the outer diameter of the wire between the neck area and the proximal end of the wire;

the tube being constructed from approximately 56% nickel and approximately 44% titanium;

the inner diameter of the tube being slightly larger than the outer diameter of the wire between the neck area and the distal end of the wire;

the tube and the wire being operatively coupled to form an elongate assembly having a proximal portion and a distal portion with the proximal end of the tube being laser welded to the neck area so as to encase the wire between the neck area and the distal end of the wire, and the distal end of the tube extending beyond the distal end of the wire to form a cavity;

the distal portion of the elongate assembly being heat treated to be more ductile relative to the proximal portion of the elongate assembly; and

a treating material being secured within the cavity.

2. The device of claim 1, wherein

substantially all of the proximal portion of the elongate assembly has a transition temperature below approximately 37°

C.

3. The device of claim 2, wherein

the distal portion of the elongate assembly is heat treated by inserting the distal portion in an oven preheated to a range of approximately 300°

C. to approximately 450°

C. and keeping the distal portion in the oven for over 200 minutes.

4. The device of claim 1, wherein

substantially all of the proximal portion of the elongate assembly has a transition temperature below approximately 25°

C.

5. The device of claim 4, wherein

the distal portion of the elongate assembly is heat treated by inserting the distal portion in an oven preheated to a range of approximately 300°

C. to approximately 450°

C. and keeping the distal portion in the oven for over 200 minutes.

6. The device of claim 1, wherein

the treating material is radioactive.

7. The device of claim 1, wherein

the treating material is secured within the cavity by an end plug.

8. A flexible treatment device for treating a selected site within a patient'"'"'s body comprising:

a flexible, predominantly solid, thin elongate wire having an outer diameter, a proximal end and a distal end, the wire having a tapered neck area between the proximal end and the distal end with the outer diameter of the wire being smaller between the neck area and the distal end than between the neck area and the proximal end;

the wire being constructed from approximately 56% nickel and approximately 44% titanium;

a flexible, hollow, elongated tube having a proximal end, a distal end, an outer diameter and an inner diameter with the outer diameter of the tube being substantially the same as the outer diameter of the wire between the neck area and the proximal end of the wire;

the tube being constructed from approximately 56% nickel and approximately 44% titanium;

the inner diameter of the tube being slightly larger than the outer diameter of the wire between the neck area and the distal end of the wire;

the tube and the wire being operatively coupled to form an elongate assembly with the proximal end of the tube being laser welded to the neck area so as to encase the wire between the neck area and the distal end of the wire, and the distal end of the tube extending beyond the distal end of the wire to form a cavity;

the tube being heat treated to be more ductile relative to the wire; and

a treating material being secured within the cavity.

9. The device of claim 8, wherein

substantially all of the wire has a transition temperature below approximately 37°

C.

10. The device of claim 9, wherein

the tube is heat treated by inserting it in an oven preheated to a range of approximately 300°

C. to approximately 450°

C. and keeping the tube in the oven for over 200 minutes.

11. The device of claim 8, wherein

substantially all of the wire has a transition temperature below approximately 25°

C.

12. The device of claim 11, wherein

the tube is heat treated by inserting it in an oven preheated to a range of approximately 300°

C. approximately 450°

C. and keeping the tube in the oven for over 200 minutes.

13. The device of claim 8, wherein

the treating material is radioactive.

14. The device of claim 8, wherein

the treating material is secured within the cavity by an end plug.

15. A flexible treatment device for treating a selected site within a patient'"'"'s body comprising:

a flexible, predominantly solid, thin elongate wire having an outer diameter a proximal end and a distal end, the wire having a neck area between the proximal end and the distal end with the outer diameter of the wire being smaller between the neck area and the distal end than between the neck area and the proximal end;

a flexible, hollow, elongated tubular member having an inner diameter, a proximal end, and a distal end;

the inner diameter of the tubular member being slightly larger than the outer diameter of the wire between the neck area and the distal end of the wire;

the proximal end of the tubular member being operatively coupled to the neck area so as to encase the wire between the neck area and the distal end of the wire, and the distal end of the tubular member extending beyond the distal end of the wire to form a cavity; and

a treating material secured within the cavity.

16. The invention of claim 15, wherein

the proximal end of the tubular member is soldered to the neck area of the wire.

17. The invention of claim 15, wherein

the proximal end of the tubular member is welded to the neck area of the wire.

18. The invention of claim 15, wherein

the wire and the tubular member are constructed from a superelastic alloy having a transition temperature below approximately 37°

C.

19. The invention of claim 18, wherein

the tubular member is a tube.

20. The invention of claim 18, wherein

the tubular member is a coil.

21. The invention of claim 18, wherein

the proximal end of the tubular member is laser welded to the neck area of the wire.

22. The invention of claim 15, wherein

the treating material is radioactive.

23. The invention of claim 18, wherein

the treating material is secured within the cavity by an end plug.

24. The invention of claim 15, wherein

the wire and the tubular member form an elongate assembly, having a distal end and a proximal end,

the wire and the tubular member being constructed from a shape-memory/superelastic alloy;

a portion of the elongate assembly at the distal end of the elongate assembly having a transition temperature above approximately 37°

C.; and

substantially all of the remainder of the elongate assembly having a transition temperature below approximately 37°

C.

25. The invention of claim 24, wherein

the proximal end of the tubular member is soldered to the neck area of the wire.

26. The invention of claim 24, wherein

the proximal end of the tubular member is welded to the neck area of the wire.

27. The invention of claim 24, wherein

the proximal end of the tubular member is laser welded to the neck area of the wire.

28. The invention of claim 24, wherein

the tubular member is a tube.

29. The invention of claim 24, wherein the distal portion of the elongate assembly is from 1" to 12" in length.

30. The invention of claim 24, wherein

the distal portion of the elongate assembly is from 3" to 9" in length.

31. The invention of claim 24, wherein

the recovery temperature of the distal portion of the elongate assembly is altered by heat treatment comprising exposing the distal portion to a temperature of 300°

C. to 450°

C. for 200 to 500 minutes.

32. The invention of claim 24, wherein

the superelastic alloy comprises approximately 55.6% nickel and approximately 44.4% titanium.

33. The invention of claim 27, wherein

the superelastic alloy comprises approximately 55.6% nickel and approximately 44.4% titanium.

34. The invention of claim 31, wherein

the superelastic alloy comprises approximately 55.6% nickel and approximately 44.4% titanium.

35. A flexible treatment device for treating a selected site within a patient'"'"'s comprising:

a flexible, predominantly solid, thin elongate wire composed of a superelastic alloy having a proximal end and a distal end;

a flexible, hollow, elongated tube composed of a superelastic alloy having a proximal end and a distal end;

the proximal end of the tube being operatively coupled to a coupling point on the wire short of the distal end of the wire so as to encase the wire between the coupling point and the distal end of the wire and forming a wire/tube assembly wherein the distal end of the tube extends beyond the distal end of the wire to form a cavity;

the wire/tube assembly having a distal end and a proximal end; and

the distal end of the wire/tube assembly is metallurgically treated to have increased deformability relative to the proximal end of the wire/tube assembly.

36. The invention of claim 35, wherein

the wire and the tube are constructed from an alloy comprising approximately 55.6% titanium and approximately 44.4% nickel.

37. The invention of claim 36, wherein

the distal end of the wire/tube assembly is heat treated to make it more ductile relative to the proximal end of the wire/tube assembly.

38. A flexible treatment device for treating a selected site within a patient'"'"'s comprising:

a flexible, elongate wire composed of a superelastic alloy having a proximal end and a distal end;

a flexible, hollow, elongated tube composed of a superelastic alloy having a proximal end and a distal end;

the proximal end of the tube being operatively coupled to a coupling point on the wire short of the distal end of the wire so as to encase a portion of the wire and form a wire/tube assembly having a distal end and a proximal end; and

the distal end of the wire/tube assembly being treated to be less superelastic relative to the proximal end of the wire/tube assembly.

39. The invention of claim 38, wherein

the wire and the tube are constructed from an alloy comprising approximately 56% titanium and 44% nickel.

40. The invention of claim 39, wherein

the distal end of the wire/tube assembly is treated to be less superelastic relative to the proximal end of the wire/tube assembly by inserting the distal end in an oven preheated to a range of approximately 300°

C. to approximately 450°

C. and keeping the distal end in the oven for over 200 minutes.