Ultrasonic angioplasty device incorporating an ultrasound transmission member made at least partially from a superelastic metal alloy

• US 5,397,301 A
• Filed: 07/19/1993
• Issued: 03/14/1995
• Est. Priority Date: 01/11/1991
• Status: Expired due to Term

• Current Assignee: Cybersonics, Inc
• Original Assignee: Baxter International Inc.
• Inventors: Bacich, Steven, Nita, Henry, Siegel, Robert, DeCastro, Eugene, Bond, Geoffrey, Pflueger, Russell
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US08/094,416
• Time in Patent Office: 603 Days
• Field of Search: 604/22, 604/53, 604/49, 128/24 AA, 606/169-171
• US Class Current: 604/22
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 18/1206 Generators therefor
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00146 with multiple frequencies
• CPC Class Codes: A61B 2017/00849 with respect to tissue, e.g. hollow organs
• CPC Class Codes: A61B 2017/00973 pedal-operated
• CPC Class Codes: A61B 2017/22018 segmented along its length
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22041 outside the catheter
• CPC Class Codes: A61B 2017/320073 probe
• CPC Class Codes: A61B 2017/320088 with acoustic insulation, e.g. elements for damping vibrations between horn and surrounding sheath
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0042 using a fluid, e.g. circulating
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters

Abstract

An ultrasonic angioplasty device comprising an elongate ultrasound transmission member having a proximal end attachable to an ultrasound generating device and a bulbous distal head or probe formed on the distal end thereof for effecting ablative treatment of an occluding lesion. The ultrasound transmission member may be formed of one or more superelastic metal alloys such as NiTi (50 at. % Ni). A guidewire lumen may be formed in the distal head or probe to permit passage of a guidewire therethrough. Portions of the ultrasound transmission member may be curved or bent. Portions of the ultrasound transmission member may be tapered or narrowed. One or more surface disruptions may be formed on the distal head or probe to improve treatment efficacy. An increased hardness coating or outer skin may be formed on the ultrasound transmission member. The device of the present invention may be incorporated into an angioscopic device.

Claims

1. An ultrasonic angioplasty device, comprising:

an elongate flexible catheter having a proximal end, a distal end and at least one lumen extending longitudinally therethrough;

an ultrasound transmission member extending longitudinally through the lumen of said flexible catheter to transmit ultrasonic energy from the proximal end of said catheter to the distal end thereof;

said ultrasound transmission member being formed of a metal alloy material comprised of at least two metal elements, the relative amounts of said metal elements in said alloy being such that said alloy exhibits an ultimate tensile strength at 20°

of approximately 1150 Mpa and a superelastic temperature range of approximately 20°

-80°

;

wherein, when said flexible catheter is placed in a bent configuration inside a mammalian vessel, said ultrasound transmission member will concomitantly assume a bent configuration.

2. The ultrasonic angioplasty device of claim 1 wherein the relative amounts of said metal elements in said alloy are further such that said alloy exhibits an unloading plateau stress at 20°

C. of approximately 135 MPa.

3. The ultrasonic angioplasty device of claim 1 wherein the relative amounts of said metal elements in said alloy are further such that said alloy exhibits a permanent set at 20°

C. after 8% strain of approximately 0.2%.

4. The ultrasonic angioplasty device of claim 1 wherein the relative amounts of said metal elements in said alloy are further such that said alloy exhibits an elongation at failure at 20°

C. of approximately 10.0%.

5. The ultrasonic angioplasty device of claim 1 wherein the relative amounts of said metal elements in said alloy are further such that said alloy exhibits a melting point of approximately 1350°

C.

6. The ultrasonic angioplasty device of claim 1 wherein said alloy of which said ultrasound transmission member is formed has a density of approximately 6.5 g/cm.

7. The ultrasonic angioplasty device of claim 1 wherein said ultrasound transmission member is formed of nickel-titanium alloy having a nickel content of approximately 50.8 At. % nickel.

8. The ultrasonic angioplasty device of claim 1 further comprising:

an ultrasound generation means connected to said ultrasound transmission member, said ultrasound generation means being operative to send ultrasonic energy through said ultrasound transmission member.

9. The ultrasonic angioplasty device of claim 8 further comprising:

temperature control means for controlling the temperature of said ultrasound transmission member within its super-elastic temperature range of approximately 20°

-80°

C. while said ultrasonic energy is being passed through said ultrasound transmission member.

10. The ultrasonic angioplasty device of claim 9 wherein said temperature control means comprises:

a fluid flow channel through which fluid may be infused through said catheter in contact with said ultrasound transmission member to effect said temperature control of said ultrasound transmission member.

11. The ultrasonic angioplasty device of claim 10 wherein said temperature control means further comprises:

means for controlling the flow rate of fluid through said fluid flow channel to maintain said ultrasound transmission member within said super elastic temperature range of approximately 20°

-80°

C.

12. The ultrasonic angioplasty device of claim 10 wherein said temperature control means further comprises:

means for controlling the temperature of said fluid to maintain said ultrasound transmission member within said super elastic temperature range of approximately 20°

-80°

C.