Superelastic guiding member

• US 5,637,089 A
• Filed: 02/12/1996
• Issued: 06/10/1997
• Est. Priority Date: 12/18/1990
• Status: Expired due to Term

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Abrams, Robert M., Fariabi, Sepehr
• Primary Examiner(s): Millin, Vincent
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/598,639
• Time in Patent Office: 484 Days
• Field of Search: 128/657, 128/712, 128/833, 604/95, 604/280, 604/283, 604/281, 604/282, 604/164, 604/170, 606/78, 606/60, 606/200, 606/108
• US Class Current: 604/95.01
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09141 made of shape memory alloys which take a particular shape at a certain temperature
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: C22C 14/00 Alloys based on titanium
• CPC Class Codes: C22C 30/00 Alloys containing less than 50% by weight of each constituent
• CPC Class Codes: C22F 1/006 Resulting in heat recoverable alloys with a memory effect

Abstract

An improved guiding member for use within a body lumen having a unique combination of superelastic characteristics. The superelastic alloy material has a composition consisting of about 30% to about 52% (atomic) titanium, and about 38% to 52% nickel and may have one or more elements selected from the group consisting of iron, cobalt, platinum, palladium, vanadium, copper, zirconium, hafnium and niobium. The alloy material is subjected to thermomechanical processing which includes a final cold working of about 10 to about 75% and then a heat treatment at a temperature between about 450° and about 600° C. and preferably about 475° to about 550° C. Before the heat treatment the cold worked alloy material is preferably subjected to mechanical straightening. The alloy material is preferably subjected to stresses equal to about 5 to about 50% of the room temperature ultimate yield stress of the material during the thermal treatment. The guiding member using such improved material exhibits a stress-induced austenite-to-martensite phase transformation at an exceptionally high constant yield strength of over 90 ksi for solid members and over 70 ksi for tubular members with a broad recoverable strain of at least about 4% during the phase transformation. An essentially whip free product is obtained.

Claims

1. An intravascular guidewire comprising

a) an elongated member having a proximal portion and a distal portion and being formed at least in part of a superelastic alloy consisting essentially of about 30 to about 52% titanium, about 38 to about 52% nickel and up to 20% additional alloying elements selected from the group consisting of iron, cobalt, platinum, palladium, copper and vanadium, said alloy part having an austenite phase which has a final transformation temperature below about 45°

C., which transforms to a martensite phase upon the application of stress and which has been thermomechanically formed in a procedure which includes a final cold working followed by a heat treatment at a temperature between about 450°

to about 600°

C. while applying tension to the cold worked elongated member; and

b) torquing means on the proximal portion of the elongated member.

2. The guidewire of claim 1 wherein the alloy contains one or more additional alloying elements selected from the group consisting of iron, cobalt, platinum and palladium in amounts of up to about 3%.

3. The guidewire of claim 1 wherein the alloy contains one or more additional alloying elements selected from the group consisting of copper in amounts of up to 12% and vanadium in amounts of up to about 10%.

4. The guidewire of claim 1 wherein the temperature of the heat treatment is between about 475°

and about 550°

C.

5. The guidewire of claim 1 wherein the superelastic part has a straight memory at a temperature less than about 45°

C.

6. The guidewire of claim 1 wherein the final cold worked alloy part is mechanically straightened before the heat treatment.