Superelastic guiding member

• US 6,592,570 B2
• Filed: 06/18/2001
• Issued: 07/15/2003
• Est. Priority Date: 12/18/1990
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Abrams, Robert M., Fariabi, Sepehr
• Primary Examiner(s): Zimmerman, John J.
• Application Number:
  US09/884,432
• Publication Number:
  US 20020046785A1
• Time in Patent Office: 757 Days
• Field of Search: 428/660, 428/615, 600/585, 600/434, 604/525, 604/529, 604/530, 604/531, 604/532
• US Class Current: 604/525
• 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:

an elongated high strength proximal portion having proximal and distal ends; and

a distal portion having proximal and distal ends formed of a superelastic alloy in an austenite phase at body temperature, which transforms to a martensite phase when subjected to stress;

wherein the elongated high strength proximal portion and said distal portion are coupled together by one of crimping, swaging, welding, soldering, brazing or applying an adhesive to secure one to the other.

2. The guidewire of claim 1, wherein the elongated high strength proximal portion and the distal portion are coupled together using solder.

3. The guidewire of claim 1, wherein the elongated high strength proximal portion has a distal end having about uniform dimensions and the distal portion has a proximal end having about uniform dimensions for coupling together.

4. The guidewire of claim 3, wherein the elongated high strength proximal portion has a distal end having about uniform cross-section along a length and the distal portion has a proximal end having about uniform cross-section along a length for coupling together.

5. The guidewire of claim 1, further comprising a superelastic tube portion for coupling the elongated high strength proximal portion and the distal portion together.

6. The guidewire of claim 5, further comprising a tube portion that fits over part of the elongated high strength proximal portion to couple said elongated high strength proximal portion to the distal portion.

7. The guidewire of claim 1, further comprising a tube portion that fits over part of the distal portion to couple said distal portion to the elongated high strength proximal portion.

8. The guidewire of claim 6, further comprising a tube having a portion that fits over part of the distal portion and having a portion that fits over part of the elongated high strength proximal portion to couple said proximal portion to said distal portion.

9. An intravascular guidewire, comprising:

an elongated high strength proximal portion having proximal and distal ends, a distal section terminating at the distal end; and

a distal superelastic portion having proximal and distal ends, a proximal section of said distal superelastic portion terminating at the proximal end;

wherein the distal end of the elongated high strength proximal portion has about uniform cross-section along a length and the proximal end of the distal superelastic portion has about uniform cross-section along a length for coupling together.

10. The guide of claim 9, further comprising an agent for coupling the elongated high strength proximal portion and the distal superelastic portion together.

11. The guidewire of claim 10, wherein the agent is one of an adhesive, solder, weld, and braze.

12. The guidewire of claim 9, further comprising a tube that fits over the proximal section of the distal superelastic portion to couple said distal superelastic portion to the elongated high strength proximal portion.

13. The guidewire of claim 9, further comprising a tube that fits over the distal section of the elongated high strength proximal portion to couple said proximal portion to said distal superelastic portion.

14. An intravascular guidewire, comprising:

an elongated high strength proximal portion; and

a superelastic portion more distal to the elongated proximal portion, said superelastic portion formed of superelastic alloy in an austenite phase at body temperature and transforms to a martensite phase when subjected to stress;

wherein a fitting relationship allows the superelastic portion and the elongated high strength proximal portion to be coupled together by one of crimping, swaging, welding, soldering, brazing or applying an adhesive to secure one to the other.

15. The method of claim 14, wherein the fitting relationship includes a high strength rod-shaped portion inseparably fitted into a nickel-titanium-containing tube-shaped portion.

16. An intravascular guidewire, comprising:

an elongated high strength proximal portion including a proximal section and a distal section; and

a superelastic portion having a proximal section and a tapered distal section that is more distal to the elongated proximal portion, said superelastic portion formed of a superelastic alloy having nickel and titanium, the superelastic portion being in an austenite phase at body temperature and transforming to a martensite phase when subjected to stress, the superelastic portion and the elongated high strength proximal portion being coupled together via a fitting relationship by one of crimping, swaging, welding, soldering, brazing, or using an adhesive to effect torque transmission capability between the superelastic portion and the elongated high strength proximal portion.