Guide wire for a catheter

• US 5,230,348 A
• Filed: 10/11/1991
• Issued: 07/27/1993
• Est. Priority Date: 10/12/1990
• Status: Expired due to Term

• Current Assignee: Dymec Co., Ltd., Nippon Seisen Co., Ltd., Clinical Supply Company (Terumo Corporation)
• Original Assignee: Dia Medical Supply, Inc., Nippon Seisen Co., Ltd., Clinical Supply Company (Terumo Corporation)
• Inventors: Matsuda, Jun, Ishibe, Hideomi, Hashimoto, Teruo, Kamishohara, Kazunori, Yamada, Yukoh, Karaki, Tamotsu
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US07/775,814
• Time in Patent Office: 655 Days
• Field of Search: 128/657, 128/772, 604/95, 604/164, 604/280-283
• US Class Current: 600/585
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09108 Methods for making a guide wire
• 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

Abstract

A guide wire for a catheter is disclosed that includes a core wire and a sheath for covering at least the distal end of the core wire. The core wire is formed from a nickel-titanium alloy having a nickel-titanium ratio in the range of 3:2 to 1:1. The core wire is worked in a manner such that in a tensile test wherein the core wire is elongated by at least 5%, the core wire has a recovery percentage of at least 90%. Additionally, elongations in the range of zero and 5% do not cause any stress-induced martensitic transformations and/or austinite reverse transformations. Thus, the load-elongation characteristics of the nickel-titanium alloy are such that the load increasing rate is either proportional or gradually decreasing throughout the elongation range of 0 to 5%.

Claims

1. A guide wire for a catheter comprising:

a core wire formed from a nickel-titanium alloy having a nickel-titanium ratio by weight in the range of 3;

2 to 1;

1, the core wire being fashioned such that in a tensile test wherein the core wire is elongated by at least 5%, the core wire has a recovery percentage of at least 90%, and such that elongations of 5% do not cause any martensitic transformations or martensitic reverse transformations; and

a sheath for covering at least a distal end of the core wire.

2. The guide wire according to claim 1, wherein the loadelongations characteristics of the nickel-titanium alloy are such that the load increasing rate is either proportional or gradually decreasing throughout the elongation range of 0.8 to 5%.

3. The guide wire according to claim 1, wherein the core wire has such a characteristic that a ratio (B/A) of a value of maximum load loss (B) to a value of maximum load (A) is at most 0.3 in the elongation range of 0% to 5%.

4. The guide wire according to claim 1, wherein the nickel-titanium alloy consists essentially of nickel and titanium and has a nickel content i the range of 50% to 60% by weight.

5. The guide wire according to claim 4, wherein the nickel-titanium alloy is produced by a diffusing method and has a nickel content of 55.0% to 57.0%.

6. The guide wire according to claim 1, wherein the nickel-titanium alloy includes a third element selected from a group consisting of copper, aluminum, iron, zinc and cobalt, the third element constituting at most 5% of the alloy by weight.

7. The guide wire according to claim 1, wherein the core wire has a body portion of 0.2 mm to 1.0 mm in diameter.

8. The guide wire according to claim 1, wherein the core wire has a tapered portion whose cross-sectional area continuously decreases toward the distal end.

9. The guide wire according to claim 1, wherein the core wire has an enlarged bulb at the distal end.

10. The guide wire according to claim 1, wherein the sheath is made of a macromolecular compound selected from a group consisting of polyurethane, polyethylene, nylon, silicone resin, Teflon, cellulose, starch, and gelatin.

11. The guide wire according to claim 1, wherein the temperature in the range of -60°

C. and 50°

C. does not cause the core wire to make any martensitic transformations or martensitic reverse transformations.

12. A guide wire for a catheter comprising:

a core wire made of nickel-titanium alloy consisting essentially of nickel and titanium and being produced by a diffusing method, the nickel content of the core wire being in the range of 55.0% to 57.0% by weight;

the core wire being fashioned such that in a tensile test wherein the core wire is elongated by at least 5%, the core wire has a recovery percentage of at least 90%, and such that elongations of 5% do not cause any martensitic transformations or martensitic reverse transformations the load-elongations characteristics of the nickel-titanium alloy being such that the load increasing rate is either proportional or gradually decreasing throughout the elongation range of 9% to 5%; and

a sheath for covering at least a distal end of the core wire, the sheath being made of a macromolecular compound selected from a group consisting of polyurethane, polyethylene, nylon, silicone resin, polytetrafluoroethylene, cellulose, starch, and gelatin.

13. The guide wire according to claim 12, wherein the core wire has a characteristic such that a ratio (B/A) of a value of maximum load loss (B) to a value of maximum load (A) is at most 0.3 in the elongation range of 0% to at least 5%.

14. The guide wire according to claim 12, wherein the core wire has a body portion having a diameter in the range of 0.2 mm to 1.0 mm, and a tapered portion having a cross-sectional area that continuously decreases toward the distal end.

15. The guide wire according to claim 12, wherein the temperature in the range of -60°

C. and 50°

C. does not cause the core wire to make any martensitic transformations or martensitic reverse transformations.

16. A guide wire for a catheter comprising:

a core wire formed from a nickel-titanium alloy having a nickel-to-titanium ratio by weight in the range of 3;

2 to 1;

1,

the core wire being produced by subjecting the nickel-titanium alloy to cold drawing to reduce its cross-section by 35% to 50% and heat-treating the cold drawn alloy at a temperature of 350°

C. to 400°

C. for 10 seconds to 30 seconds, whereby the core wire is fashioned such that in a tensile test in which the core wire is elongated by at least 5%, the core wire has a recovery percentage of at least 90%, and such that elongations of 5% do not cause any martensitic transformations or martensitic reverse transformations; and

a sheath for covering at least a distal end of the core wire.