Ultrasound catheter system having modulated output with feedback control

• US 5,447,509 A
• Filed: 10/04/1993
• Issued: 09/05/1995
• Est. Priority Date: 01/11/1991
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Baxter International Inc.
• Inventors: Nita, Henry, Mills, Timothy C.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US08/131,796
• Time in Patent Office: 701 Days
• Field of Search: 606/1, 606/2.5, 606/169-171, 607/97-99, 128/660.01-660.03, 128/662.03-662.06, 128/24, 128/44, 604/22, 601/2, 601/4
• US Class Current: 606/1
• 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 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22041 outside the catheter
• 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
• CPC Class Codes: A61M 3/0279 Cannula; Nozzles; Tips; their connection means

Abstract

A method and apparatus for driving an ultrasound transducer coupled to an ultrasound transmission disposed within an elongate catheter has a modulated output and utilizes feedback control. A modulating signal varying in amplitude and continuous in duration modulates an ultrasound transducer drive signal. The resulting modulated ultrasound transducer drive signal is likewise continuous in duration such that it lacks the abrupt accelerations which cause stress to be applied to the ultrasound transmission member in prior art devices. The current of the modulated drive signal is monitored and the voltage thereof is varied in response to changes in the current in order to provide feedback control. A transmission member breakage alarm provides an indication of transmission member breakage in the event that any comparison of the drive energy to the feedback control signal indicates that the desired ultrasonic vibration has been reached at a drive energy level less than the minimum drive energy level typically desired for such desired ultrasound vibration when the ultrasound transmission member is intact.

Claims

1. A method for driving an ultrasound transducer coupled to an ultrasound catheter having an ultrasound transmission member extending longitudinally therethrough such that the distal end of the ultrasound transmission member oscillates at a desired operational ultrasound frequency, said method comprising the steps of:

a) providing a modulating signal, the modulating signal varying in amplitude and being continuous in duration;

b) applying said modulating signal to an ultrasound transducer drive signal so as to modulate the ultrasound transducer drive signal; and

c) wherein the resulting modulated ultrasound transducer drive signal is continuous in duration and devoid of high frequency components which exceed the desired operational ultrasound frequency.

2. The method of claim 1 wherein the step of providing a modulating signal further comprises the step of providing a sine wave.

3. The method of claim 1 further comprising the steps of:

a) monitoring the current of the modulated drive signal;

b) varying the amplitude of the voltage of the modulated drive signal in response to changes in the current thereof; and

c) wherein varying the amplitude of the voltage of the modulated drive signal in response to changes in the current thereof enhances ablation by reducing undesirable variations in ultrasound energy used therefor.

4. The method of claim 1 further comprising the step of selecting the modulating signal from a plurality of different modulating signals, each of the different modulating signals being an optimized function for a particular application.

5. The method as recited in claim 1 further comprising the steps of:

a) measuring a feedback control signal representing the ultrasonic vibration at the distal-most extent of the ultrasound transmission member;

b) defining the minimal drive energy typically required to obtain a desired induced feedback control signal when the ultrasound transmission member is unbroken;

c) periodically or continually comparing the drive energy being delivered to the induced feedback control signal being received; and

d) providing a breakage alarm in the event that any comparison of said drive energy to said induced feedback control signal indicates that said desired ultrasonic vibration has been reached at a drive energy level less than said minimum drive energy level typically required for such desired ultrasound vibration when said ultrasound transmission member is intact.

6. The method of claim 1, further comprising the step of optimizing said modulating signal for the ablation of atherosclerotic plaque.

7. The method of claim 1, further comprising the step of optimizing said modulating signal for the ablation of thrombotic matter.

8. A method for therapeutic treatment of a patient, said method comprising the steps of:

a) positioning the distal end of an elongate ultrasound transmission member at a location within a mammalian body;

b) applying a modulated electrical drive signal to an ultrasound transducer, the drive signal varying in amplitude and being continuous in duration; and

c) transmitting the modulated ultrasound energy provided by the ultrasound transducer through an elongate ultrasound transmission member to a desired location within the mammalian body.

9. The method of claim 8 further comprising the step of disposing said ultrasound transmission member within a catheter sheath.

10. The method of claim 8 wherein the step of applying a modulated ultrasound transducer drive signal comprises modulating a constant amplitude ultrasound transducer drive signal with a varying and continuous modulating signal.

11. The method of claim 8 wherein the step of positioning the distal end of an ultrasound transmission member within a mammalian body comprises positioning the distal end of the ultrasound transmission member within a lumen of a blood vessel.

12. A method for driving an ultrasound transducer coupled to an ultrasound transmission member, the method comprising the steps of:

a) providing an ultrasound transducer drive signal;

b) monitoring the current of said ultrasound transducer drive signal; and

c) varying the voltage of said ultrasound transducer drive signal in response to changes in the current thereof.

13. The method as recited in claim 12 further comprising the steps of:

a) measuring a feedback control signal representing the ultrasonic vibration at the distal-most extent of the ultrasound transmission member;

b) defining the minimal drive energy typically required to obtain a desired induced feedback control signal when the ultrasound transmission member is unbroken;

c) periodically or continually comparing the drive energy being delivered to the induced feedback control signal being received; and

d) providing a breakage alarm in the event that any comparison of said drive energy to said induced feedback control signal indicates that said desired ultrasonic vibration has been reached at a drive energy level less than said minimum drive energy level typically required for such desired ultrasound vibration when said ultrasound transmission member is intact.

14. An apparatus for providing ultrasound for use in therapeutic procedures, the apparatus comprising:

a) a modulated ultrasound transducer drive signal generator for providing a continuous and varying modulated ultrasound transducer drive signal;

b) an ultrasound transducer receiving said modulated ultrasound transducer drive signal and providing an ultrasound output; and

c) an ultrasound transmission member having a distal tip, attached to said ultrasound transducer for transmitting ultrasound from said ultrasound transducer to an intracorporeal location where required for therapy.

15. The apparatus as recited in claim 14 further comprising a catheter substantially covering at least a portion of said ultrasound transmission member.

16. The apparatus as recited in claim 14 further comprising a display for displaying information regarding the modulated ultrasound transducer drive signal.

17. The apparatus as recited in claim 14 wherein said modulated ultrasound transducer drive signal generator comprises:

a) a modulating signal generator for providing a varying and continuous modulating signal;

b) an ultrasound transducer drive signal generator for providing an ultrasound drive signal; and

c) a modulator for applying the modulating signal to the drive signal so as to generate a modulated ultrasound transducer drive signal.

18. The apparatus as recited in claim 17 further comprising:

a) a current sensor coupled to the modulator for sensing current of the modulated ultrasound transducer drive signal; and

b) a feedback control coupled to the current sensor and the ultrasound transducer drive signal generator for varying the voltage of the ultrasound transducer drive signal in response to changes in power delivered at the distal tip of the ultrasound transmission member.

19. In an ultrasonic system for ultrasonic ablation of matter within an anatomical structure of a mammalian body, said system comprising an ultrasound transducer coupled to an elongate ultrasound delivery catheter having an ultrasound transmitting member extending longitudinally therethrough, a method of detecting breakage of said ultrasound transmission member during use, said method comprising the steps of:

a) measuring a feedback control signal representing the ultrasonic vibration at the distal-most extent of the ultrasound transmission member;

b) defining the minimal drive energy typically required to obtain a desired induced feedback control signal when the ultrasound transmission member is unbroken;

c) periodically or continually comparing the drive energy being delivered to the induced feedback control signal being received; and

d) providing a breakage alarm in the event that any comparison of said drive energy to said induced feedback control signal indicates that said desired ultrasonic vibration has been reached at a drive energy level less than said minimum drive energy level typically required for such desired ultrasound vibration when said ultrasound transmission member is intact.