Flexible guide having two-way shape memory alloy

• US 4,984,581 A
• Filed: 10/12/1988
• Issued: 01/15/1991
• Est. Priority Date: 10/12/1988
• Status: Expired due to Term

• Current Assignee: ev3, Inc. (Medtronic Plc)
• Original Assignee: FlexMedics Corp. (KOCH Industries Incorporated)
• Inventors: Stice, James D.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US07/256,658
• Time in Patent Office: 825 Days
• Field of Search: 128/657, 128/772, 604/95, 604/164, 604/170, 604/280, 604/282
• US Class Current: 600/585
• CPC Class Codes: A61F 2/0004 Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
• CPC Class Codes: A61F 2210/0033 electrically, e.g. heated by resistor
• CPC Class Codes: A61M 2025/09083 having a coil around a core
• CPC Class Codes: A61M 2025/09091 where a sheath surrounds the coil at the distal part
• CPC Class Codes: A61M 2025/09141 made of shape memory alloys which take a particular shape at a certain temperature
• CPC Class Codes: A61M 25/0158 with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

A medical guide wire for insertion into body channels for accessing specific inner body areas without major surgery. The guide wire comprises an elongated, flexible guide having a core of a shape memory alloy, the guide utilizing the two-way memory properties of the shape memory alloy to impart tip-deflecting and rotational movement to the guide wire in response to a controlled thermal stimulus.

Claims

1. A guidewire comprising an elongated, flexible core of a shape memory alloy which is changeable between a pseudoelastic austenitic phase structure and a pseudoelastic R-phase structure, the austenitic and R-phase structures having different predetermined corresponding core shapes, the core being selectively changeable between said phase structures in response to a thermal stimulus to impart tip-deflecting movement to the guidewire.

2. The guide wire of claim 1 wherein the core is selectively changeable between phases in response to a thermal stimulus to impart rotational movement to the guide wire.

3. The guide wire of claim 1 wherein the core is formed of Niti alloy.

4. The guide wire of claim 1 including a distal sheath comprising an elongated, helically wound wire coil providing a flexible tip, the core extending forwardly within the tip and terminating forwardly in an enlarged diameter portion of generally circular cross section and defining a plug carried adjacent the forward end of the coil, the plug being substantially radially symmetrical with respect to the coil, and an electrically conductive bonding agent bonding the plug to the coil to permit electrical current supplied to the core to travel through the core and the plug and into surrounding body tissue, the shape memory alloy core having an electrically resistive forward portion capable of R phase/austenitic phase transformation in response to an increased temperature resulting from application of an electric current to the core.

5. The guide wire of claim 1 including a forward flexible sheath comprising an elongated, helically wound wire coil providing a flexible tip, the core extending forwardly within the tip and terminating forwardly in an integral enlarged diameter portion of generally circular cross section and defining a plug carried adjacent the forward end of the coil, the plug being substantially radially symmetrical with respect to the coil, an electrically insulative bonding agent bonding the plug to the coil, and an elongated, electrically conductive element extending along the length of the guide wire electrically connected to the plug, the element being electrically isolated from the core, the core having an electrically resistive forward portion capable of R-phase/austenitic phase transformation in response to an increased temperature resulting from application of an electric current to the core.

6. The guide wire of claim 5 including a second elongated, electrically conductive element extending along a portion of the length of the core and electrically connected to the core at a position spaced from the plug, the core having an electrically resistive forward portion capable of R-phase/austenitic phase transformation in response to an increased temperature resulting from application of an electric current to the core.

7. The guide wire of claim 1 comprising an elongated, flexible core having first and second longitudinally separate, electrically isolated halves, the core terminating forwardly in an integral enlarged diameter portion of generally circular cross section defining first and second halves of a plug. The two halves of the plug being connected by an electrically conductive adhesive. A forward flexible sheath comprising an elongated, helically wound wire coil providing a flexible tip, the plug carried adjacent the forward end of the coil, the plug being substantially radially symmetrical with respect to the coil, and an electrically insulative bonding agent bonding the plug to the coil, the core having an electrically resistive forward portion capable of R phase/austenitic phase transformation in response to an increased temperature resulting from application of an electric current to the core.

8. The guide wire of claim 1 wherein said elongated, flexible central core has first and second longitudinally separate, electrically isolated halves, the first half of the core terminating forwardly in an integral enlarged diameter portion of generally circular cross section defining a first half of a plug, the second half of the core terminating in a forward end defining a second half of a plug, a forward flexible sheath comprising an elongated, helically wound wire coil providing a flexible tip, an electrically insulative bonding agent bonding the plug to the coil, a first electrically conductive element extending along the length of the guide wire electrically connected to the second half of the plug, the element being electrically isolated from the core, and a second electrically conductive element extending along a portion of the length of the guide wire electrically connected to the first half of the core at a position spaced from the plug, the second element being electrically isolated from the core, the core having an electrically resistive forward portion capable of R phase/austenitic phase transformation in response to an increased temperature resulting from application of an electric current to the core.

9. The guidewire of claim 1 wherein said pseudoelastic R-phase structure core shape is stable at body temperature and conversion to said pseudoelastic austenitic phase structure core shape is substantially complete at 45°

C.

10. The guidewire of claim 1 wherein said pseudoelastic R-phase structure is substantially stable at approximately 36°

C. and conversion to said pseudoelastic austenitic phase structure core shape is substantially complete at approximately 45°

C.

11. A guidewire comprising an elongated, flexible core of a two-way shape memory alloy which is selectively changeable in response to a thermal stimulus between a first phase wherein the core has a first configuration and a second phase wherein the core has a second configuration;

an elongated, helically wound wire coil providing a flexible tip;

the core extending forwardly within the tip and terminating forwardly in an enlarged diameter portion defining a plug carried adjacent the forward end of the coil;

the position of the plug in the core'"'"'s second configuration being angularly or rotationally displaced from the position of the tip in the core'"'"'s first configuration.

12. The guide wire of claim 11 wherein the core is formed of a NiTi alloy.