Analysis of real time backscatter data for fault signal generation in a medical HIFU device

• US 9,816,968 B2
• Filed: 03/23/2010
• Issued: 11/14/2017
• Est. Priority Date: 03/23/2009
• Status: Active Grant

• Current Assignee: Solta Medical, Inc. (Bausch Health Cos., Inc.)
• Original Assignee: LipoSonix, Inc. (Bausch Health Cos., Inc.)
• Inventors: Little, Blake
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): NGUYEN, HIEN NGOC
• Application Number:
  US12/729,447
• Publication Number:
  US 20100241034A1
• Time in Patent Office: 2,793 Days
• Field of Search: 601 2
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/00725 Calibration or performance testing
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: G01N 2291/044 Internal reflections (echoes), e.g. on walls or defects
• CPC Class Codes: G01N 29/30 Arrangements for calibrating or comparing, e.g. with standard objects
• CPC Class Codes: G01N 29/343 pulse waves, e.g. particular sequence of pulses, bursts
• CPC Class Codes: G01N 29/4427 with stored values, e.g. threshold values
• CPC Class Codes: G01N 29/4454 Signal recognition, e.g. specific values or portions, signal events, signatures

Abstract

A method and system for checking functionality of an ultrasound therapy head. The waveform profile for typical ultrasound reflections for a functional therapy head are stored, and before use of a therapy head, an ultrasound energy burst (700) is sent, and the actual waveform profile of the returned reflections (702) are compared to the stored waveform profiles (706). If the actual profiles are not sufficiently close to the stored profiles, then a first signal (712) may be generated, which may cause the ultrasound therapy device to shut down or may generate a warning. If the actual profiles are sufficiently close to the stored profiles, then operation may continue (714), or a second signal may be produced, permitting operation of the ultrasound therapy device.

Claims

1. A method for detecting a transducer fault in a high intensity focused ultrasound therapy system, the method comprising:

transmitting a burst of ultrasonic energy or a pulse of ultrasonic energy from a high intensity focused ultrasound transducer mounted in a therapy head;

after the burst of ultrasonic energy or the pulse of ultrasonic energy is transmitted, applying an electrical clamp to the transducer that provides an impedance across the transducer and accelerates vibration dampening of the transducer after the burst of ultrasonic energy or the pulse of ultrasonic energy;

after the application of the electrical clamp ends, measuring a clamp waveform comprising residual electrical voltage;

comparing the clamp waveform against a stored clamp waveform profile; and

if the clamp waveform does not substantially match the stored clamp waveform profile, generating a fault signal.

2. The method of claim 1, wherein the expected clamp waveform profile is stored on a persistent memory device.

3. The method of claim 1, further comprising:

preventing the high intensity focused ultrasound therapy system from operating after the fault signal is generated.

4. A method of determining functionality of a medical ultrasound therapy head, the method comprising:

while a cap of the medical ultrasound therapy head is in contact with the patient, transmitting a burst of ultrasonic energy via a transducer that is mounted in the medical ultrasound therapy head;

receiving one or more reflections of the ultrasonic energy in the burst from objects other than the transducer within the medical ultrasound therapy head, the reflections comprising at least one waveform profile;

comparing the at least one waveform profile to an expected waveform profile for the therapy head;

generating a first signal indicating a fault if the waveform profile does not match the expected waveform profile; and

preventing an ultrasound therapy system from operating after the first signal is generated.

5. The method of claim 4, wherein the expected waveform profile comprises an expected amplitude range at a particular range of delays from the burst.

6. The method of claim 4, wherein the expected waveform profile comprises an expected maximum amplitude during an expected range of time after the burst.

7. The method of claim 4, wherein the expected waveform profile comprises an expected minimum amplitude during an expected range of time after the burst.

8. The method of claim 4, wherein the expected waveform profile comprises a permitted deviation from a plurality of defined amplitudes, each defined amplitude being a different delay from the burst.

9. The method of claim 4, further comprising:

generating a second signal indicating operation is available if the actual waveform profile of the reflection does meet the expected waveform profile.

10. The method of claim 4, wherein a plurality of reflections are arranged in sequence and compared to a corresponding sequence of expected waveform profiles, the arrangement of reflections and expected waveforms being a linear time sequence.

11. The method of claim 10, wherein the expected waveform profile comprises a permitted deviation from a plurality of defined amplitudes, each defined amplitude being a different delay from the burst.

12. The method of claim 10, wherein the expected waveform profile comprises a plurality of expected amplitude ranges, each expected amplitude range at a different delay from the burst.

13. The method of claim 10, wherein the expected waveform profile comprises a plurality of expected maximum amplitudes, each expected maximum amplitude at a different expected range of time after the burst.

14. The method of claim 4, further comprising:

capturing a ring down waveform after the burst;

comparing the ring down waveform to an expected ring down waveform profile; and

if the ring down waveform does not substantially match the expected ring down waveform profile, generating another fault signal.

15. The method of claim 14, wherein one or more expected ring down waveform profiles are stored on a persistent memory device.

16. The method of claim 14, further comprising:

if the ring down waveform does not substantially match the expected ring down waveform profile, preventing the ultrasound therapy system from operating.

17. An ultrasound therapy system comprising:

a medical ultrasound therapy head including a transducer and a cap;

a processor; and

a program module configured upon execution by the processor to determine functionality of the medical ultrasound therapy head, wherein the program module is configured to the determine the functionality of the medical ultrasound therapy head by;

while the cap of the medical ultrasound therapy head is in contact with the patient, transmitting a burst of ultrasonic energy via the transducer;

receiving one or more reflections of the ultrasonic energy in the burst from objects other than the transducer within the medical ultrasound therapy head, the reflections comprising at least one waveform profile;

comparing the at least one waveform profile to an expected waveform profile for the therapy head;

generating a fault signal if the waveform profile of the reflection does not meet the expected waveform profile; and

preventing the ultrasound therapy system from operating after the fault signal is generated.

18. The ultrasound therapy system of claim 17, further comprising:

a persistent memory device configured to store one or more expected waveform profiles.

19. The ultrasound therapy system of claim 17, wherein the program module is configured to the determine a functionality of the transducer by:

capturing a ring down waveform after the burst;

comparing the ring down waveform to an expected ring down waveform profile; and

if the ring down waveform does not substantially match the expected ring down waveform profile, generating another fault signal.

20. The ultrasound therapy system of claim 19, wherein the program module is further configured to prevent the ultrasound therapy system from operating if the ring down waveform does not substantially match the expected ring down waveform profile.