IP Library Granted Patent US 9,816,968
Granted Patent B2
US 9,816,968 · App. 12/729,447 · Granted Nov 14, 2017

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

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Quick Facts
Patent No.
US 9,816,968
App. No.
12/729,447
Granted
Nov 14, 2017
Kind
B2
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 (48)

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.

Assignments (12)
RELEASE OF SECURITY INTEREST Recorded Nov 20, 2025
From: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
To: BAUSCH HEALTH AMERICAS, INC.; BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.
Reel/Frame 073637/0126 →
RELEASE OF SECURITY INTEREST Recorded Nov 20, 2025
From: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
To: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH AMERICAS, INC.
Reel/Frame 073654/0242 →
RELEASE OF SECURITY INTEREST Recorded Nov 20, 2025
From: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
To: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH, CANADA INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
Reel/Frame 073654/0300 →
U.S. PATENT SECURITY AGREEMENT Recorded Jun 13, 2025
From: MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; BAUSCH HEALTH US, LLC (F/K/A VALEANT PHARMACEUTICALS NORTH AMERICA LLC); PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SANTARUS, INC.; BAUSCH HEALTH AMERICAS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON
Reel/Frame 071564/0463 →
U.S. PATENT SECURITY AGREEMENT Recorded Jun 13, 2025
From: MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; BAUSCH HEALTH US, LLC (F/K/A VALEANT PHARMACEUTICALS NORTH AMERICA LLC); PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SANTARUS, INC.; BAUSCH HEALTH AMERICAS, INC.; SOLTA MEDICAL, INC.
To: JPMORGAN CHASE BANK, N.A.
Reel/Frame 071566/0200 →
SECURITY AGREEMENT (SECOND LIEN) Recorded Oct 5, 2022
From: BAUSCH HEALTH US, LLC; BAUSCH HEALTH AMERICAS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061606/0468 →
SECURITY AGREEMENT (FIRST LIEN) Recorded Oct 4, 2022
From: BAUSCH HEALTH US, LLC; BAUSCH HEALTH AMERICAS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 061595/0066 →
SECURITY INTEREST Recorded Jun 13, 2022
From: BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH, CANADA INC.; BAUSCH HEALTH IRELAND LIMITED; SOLTA MEDICAL IRELAND LIMITED
To: THE BANK OF NEW YORK MELLON
Reel/Frame 060346/0705 →
SECURITY AGREEMENT Recorded Feb 10, 2022
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH AMERICAS, INC.
To: THE BANK OF NEW YORK MELLON
Reel/Frame 059121/0001 →
SECURITY INTEREST Recorded Jun 8, 2021
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH AMERICAS, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 056811/0814 →
MERGER Recorded May 13, 2021
From: AESTHERA; LIPOSONIX, INC.
To: SOLTA MEDICAL, INC.
Reel/Frame 056227/0174 →
SECURITY INTEREST Recorded Mar 11, 2019
From: BAUSCH HEALTH AMERICAS, INC.; BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 048556/0758 →