High elongation linear elastic guidewire

• US 5,238,004 A
• Filed: 09/30/1992
• Issued: 08/24/1993
• Est. Priority Date: 04/10/1990
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Sahatjian, Ronald, Alvarez de Toledo, Fernando
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US07/954,469
• Time in Patent Office: 328 Days
• Field of Search: 128/657, 128/658, 128/772, 604/90, 604/95, 604/281
• US Class Current: 600/585
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0015 Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A guidewire and a method for its manufacture, wherein at least the distal portion of the guidewire comprises an element made of a precursor of a superelastic alloy such as a Ni--Ti linear elastic alloy. The element exhibits a stress strain curve with a linear stress-strain relationship and a yield point. At room temperature to body temperature the precursor is in the martensitic phase. The distal portion of the guidewire is deformable beyond the yield point by the physician in the field to a desired set shape and exhibits resistance to kinking during insertion into the body as a result of its elasticity.

Claims

1. A guidewire device having a distal portion comprised of a precursor of a superelastic alloy, said precursor portion exhibiting no phase transition in response to deforming stress and having a linear stress-strain curve extending to a yield point without passing through a substantial plateau in which stress remains substantially constant while strain is varied, the distal precursor portion of said guidewire being deformable beyond said yield point to a desired set shape.

2. The guidewire device of claim 1 wherein said precursor is selected from the group consisting of an alloy of In--Tl, Fe--Mn, Ni--Ti, Ag--Cd, Au--Cd, Au--Cu, Cu--Al--Ni, Cu--Au--Zn, Cu--Zn, Cu--Zn--Al, Cu--Zn--Sn, Cu--Zn--Xe, Fe₃ Be, Fe₃ Pt, Ni--Ti--V, Fe--Ni--Ti--Co, and Cu--Sn.

3. The guidewire of claim 2 wherein said alloy is selected from the group consisting of Ni--Ti, Cu--Al--Ni and Cu--Zn--Al.

4. The guidewire of claim 1 wherein said precursor is an alloy of about 55%/45% Ni--Ti.

5. The guidewire device of claim 1 in which at least part of said distal portion is smaller than an integral portion of said guidewire proximal thereof, which is also comprised of said precursor of a superelastic alloy.

6. The guidewire device of claim 5 in which at least part of the guidewire formed of said precursor of a superelastic alloy is tapered from a larger to a smaller size in the direction of the distal end of said guidewire.

7. The guidewire of claim 5 in the form of an angiographic guidewire having a total length of about 145 cm, a body portion of about 0.020 to 0.290 inch diameter, a taper portion about 7 to 10 cm long and a tip portion about 2 to 10 cm long with a diameter of about 0.007 inch, said body portion, taper portion and tip portion comprised of said precursor of a superelastic alloy.

8. The guidewire of claim 5 in the form of a gastrointestinal guidewire having a total length of about 450 cm, a body portion of about 0.020 to 0.290 inch diameter, a taper portion about 7 to 10 cm long and a tip portion about 2 to 10 cm long with a diameter of about 0.007 inch, said body portion, taper portion and tip portion comprised of said precursor of a superelastic alloy.

9. The guidewire of claim 6 wherein there is a portion of said guidewire distal to said taper, said portion having diameter no greater than the diameter of the most distal portion of said taper.

10. The guidewire of claim 6 wherein the distal portion of said guidewire continuously tapers distally to the smallest diameter at the distal end of the guidewire.

11. The guidewire device of claim 1 having a core element comprised of said precursor, said core element extending proximally, integrally from said distal portion.

12. The guidewire of claim 1 further comprising a polymeric external coating.

13. The guidewire of claim 12 wherein said coating is polytetrafluoroethylene.

14. The guidewire of claim 12 wherein said coating is a lubricious polymer.

15. The guidewire of claim 12 or 14 wherein said coating includes an antithrombogenic agent.

16. The guidewire of claim 14 wherein said agent is heparin.

17. The guidewire of claim 1 wherein said distal portion comprises an element comprised of said precursor of a superelastic alloy and further including a flexible spring coil surrounding said element.

18. The guidewire of claim 17 wherein said spring coil is more flexible than said element.

19. A guidewire device having a distal portion comprised of a precursor of a superelastic alloy, selected from the group consisting of an alloy of In--Tl, Fe--Mn, Ni--Ti, Ag--Cd, Au--Cd, Au--Cu, Cu--Al--Ni, Cu--Au--Zn, Cu--Zn, Cu--Zn--Al, Cu--Zn--Sn, Cu--Zn--Xe, Fe₃ Be, Fe₃ Pt, Ni--Ti--V, Fe--Ni--Ti--Co, and Cu--Sn, said precursor portion exhibiting no phase transition in response to deforming stress and having a linear stress-strain curve extending to a yield point without passing through a substantial plateau in which stress remains substantially constant while strain is varied, the distal precursor portion of said guidewire being deformable beyond said yield point to a desired set shape, where at least part of the guidewire formed of said precursor of a superelastic alloy is tapered from a larger to a smaller size in the direction of the distal end of said guidewire where the tip of said guidewire is no larger than the most distal portion of said taper.

20. The guidewire of claim 19 wherein there is a portion of said guidewire distal to said taper, said portion having diameter no greater than the diameter of the most distal portion of said taper.

21. The guidewire of claim 19 wherein the distal portion of said guidewire continuously tapers distally to the smallest diameter at the distal end of the guidewire.

22. The guidewire of any one of claims 19 or 21 wherein said precursor is an alloy of about 55%45% Ni--Ti.

23. A guidewire device having a distal portion comprised of a Ni--Ti alloy, said portion exhibiting no phase transition in response to deforming stress and having a substantially linear stress-strain curve extending to a yield point without passing through a substantial plateau in which stress remains substantially constant while strain is varied, the distal portion of said guidewire being deformable beyond said yield point to a desired set shape.

24. The guidewire of claim 23 wherein said alloy is about 55%/45% Ni--Ti.

25. A guidewire device having a distal portion comprised of a Ni--Ti alloy in the martensite phase, said portion exhibiting no phase transition in response to deforming stress and having a substantially linear stress-strain curve extending to a yield point without passing through a substantial plateau in which stress remains substantially constant while strain is varied, the distal portion of said guidewire being deformable beyond said yield point to a desired set shape.

26. The guidewire device of claim 25 in which at least part of said distal portion is smaller than an integral portion of said guidewire proximal thereof.

27. The guidewire of claim 25 or 26 wherein said alloy is about 55%/45% Ni--Ti.