# US 12,213,832 B2 · Device and method for treatment of a patient by high-intensity focused ultrasound (HIFU)

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- Number: US 12,213,832 B2
- Document ID: US12213832B2
- Status: Granted
- Kind: B2
- Application number: 17/619,508
- Filed: 2020-06-17
- Published: 2022-08-18
- Granted: 2025-02-04
- Earliest claimed: 2019-06-19
- Assignees: Theraclion SA
- Applicants: Theraclion SA
- Inventors: Jérémie Anquez; Anthony Grisey
- Web page: https://patentgrep.com/patent/US12213832B2

## CPC

- A61B 8/4281: {characterised by sound-transmitting media or devices for coupling the transducer to the tissue}
- A61N 7/00: Ultrasound therapy (lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 {; using ultrasound for introducing media into the body A61M37/0092})
- A61B 8/485: {involving measuring strain or elastic properties}
- A61B 8/488: {involving Doppler signals}
- A61N 7/02: Localised ultrasound hyperthermia
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B 2090/378: {using ultrasound}
- A61N 2007/0082: {Scanning transducers}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

The invention relates to a device (1) and a method to avoid artefacts in second circulation mode imaging during ultrasound treatments of the human body (P). Specifically and amongst other effects, the invention provides a way to adequately control, in particular turn on and off, the fluid circulation (12) in a cavity (7) such as to avoid artefacts while still enabling practical imaging.

## Claims

### Claim 1

A device for treatment of a patient by High-Intensity Focus Ultrasound, the device comprising:
a treatment head including a High-Intensity Focus Ultrasound emitting unit, for generating High-Intensity Focus Ultrasound pulses;
an imaging device;
a pump for circulating a fluid in a cavity between the treatment head and a contact surface of the device adapted to be brought into contact with skin of the patient;
a control unit for controlling operation of the imaging device and the pump; and
wherein the control unit is adapted for operating the fluid circulation at least in a second circulation mode different from a regular circulation mode, further wherein the control unit is adapted for switching to the regular circulation mode, which comprises switching the fluid circulation on again or increasing fluid flow when a Doppler imaging mode and/or an elastography mode is deactivated.

### Claim 2 (depends on 1)

The device of claim 1, wherein the control unit is adapted for switching to the second circulation mode, which comprises stopping the fluid circulation, when the Doppler imaging mode and/or the elastography mode is activated.

### Claim 3 (depends on 1)

The device of claim 1, wherein the treatment head includes a balloon through which said fluid can be circulated and wherein the control unit is adapted to control the fluid circulation in such a way that a preset pressure is achieved within the balloon during the regular circulation mode.

### Claim 4 (depends on 3)

The device of claim 3, wherein the control unit is adapted to reactivate the regular circulation mode after a delay has elapsed after sending a command to switch to a regular imaging mode.

### Claim 5 (depends on 3)

The device of claim 3, wherein the control unit is adapted to reactivate the regular circulation mode after the imaging device has switched to and is operating in a regular imaging mode.

### Claim 6 (depends on 4)

The device of claim 4, where the control unit is adapted to temporarily change to a pressure control mode based on at least one of the following resume conditions:
a movement of the treatment head along any axis;
a measured pressure value is above or below a certain threshold relative to a current pressure setpoint;
a geometry of the skin has deformed as assessed by an automatic detection algorithm; and
a dedicated control is activated.

### Claim 7 (depends on 6)

The device of claim 6, wherein the control unit is adapted to change back from the temporary pressure control mode to the second circulation mode based on at least one of the following conditions:
no movement has been detected along any axis since a certain predefined period of time;
the pressure is within a predetermined range around the pressure setpoint;
the pressure is sufficiently stable;
in case where pressure regulation is performed using two pumps, a speed of inlet and outlet pumps, as determined by a feedback loop, are close enough from each other during a certain time;
lapse of a certain time; and
a dedicated input is activated.

### Claim 8 (depends on 1)

The device according to claim 1, wherein the control unit is adapted for reducing a speed of the fluid in the second circulation mode.

### Claim 9 (depends on 8)

The device according to claim 8, wherein the control unit is adapted for reducing the speed of the fluid to a predetermined speed.

### Claim 10

A method for treatment of a patient by High-Intensity Focused Ultrasound, the method comprising the following steps:
treating a target of the patient with High-Intensity Focused Ultrasound pulses;
circulating a fluid in a cavity between a treatment head and a contact surface of a device adapted to be brought into contact with skin of the patient in a regular circulation mode;
monitoring the target with an imaging device operating temporarily in a Doppler imaging mode and/or elastography mode; and
changing the circulation of the fluid to a second circulation mode at least temporarily during monitoring in the Doppler imaging mode.

### Claim 11 (depends on 10)

The method according to claim 10, comprising the further step of switching to the second circulation mode, comprising at least one of stopping or reducing the fluid circulation, when the Doppler imaging mode is activated, such that the Doppler imaging mode is not activated unless the second circulation mode is also activated.

### Claim 12 (depends on 10)

The method according to claim 10, comprising the further step of switching back to the regular circulation mode, which comprises switching the circulation on again or increasing fluid flow when the Doppler imaging mode is deactivated, such that the Doppler imaging mode and/or the elastography mode is not activated unless the second circulation mode is activated.

### Claim 13 (depends on 12)

The method according to claim 12, further comprising the step of reactivating the regular circulation mode after a delay has elapsed after sending a command to switch to the regular imaging mode.

### Claim 14 (depends on 13)

The method according to claim 13, further comprising the step of temporarily changing to a pressure control mode based on at least one of the following conditions:
a movement of the treatment head along any axis;
a measured pressure value is above or below a certain threshold relative to a current pressure setpoint;
a geometry of the skin has deformed as assessed by an automatic detection algorithm; and
a dedicated control is activated.

### Claim 15 (depends on 14)

The method according to claim 14, further comprising the step of changing back from the temporary pressure control mode to the second circulation mode based on at least one of the following conditions:
no movement has been detected along any axis since a certain predefined period of time;
the pressure is within a predetermined range around the pressure setpoint;
the pressure is sufficiently stable;
in case where pressure regulation is performed using two pumps, a speed of inlet and outlet pumps, as determined by a feedback loop, are close enough from each other during a certain time;
lapse of a certain time; and
a dedicated input is activated.

### Claim 16 (depends on 10)

The method according to claim 10, wherein a treatment device comprises a balloon through which the fluid can be circulated and wherein the method further comprises the step of controlling the fluid circulation in such a way that a preset pressure is achieved within the balloon during the regular circulation mode.

### Claim 17 (depends on 10)

The method according to claim 10, further comprising the step of reactivating the regular circulation mode after the imaging device has switched to and is operating in the regular imaging mode.

### Claim 18 (depends on 10)

The method according to claim 10, further comprising the step of reducing a speed of the fluid in the second circulation mode.

### Claim 19 (depends on 18)

The method according to claim 18, wherein the speed of the fluid is reduced to a predetermined speed.

### Claim 20

A device for treatment of a patient by High-Intensity Focus Ultrasound, the device comprising:
a treatment head including a High-Intensity Focus Ultrasound emitting unit, for generating High-Intensity Focus Ultrasound pulses;
an imaging device;
a pump for circulating a fluid in a cavity between the treatment head and a contact surface of the device adapted to be brought into contact with skin of the patient; and
a control unit for controlling operation of the imaging device and the pump wherein the control unit is adapted for operating the fluid circulation at least in a second circulation mode different from a regular circulation mode wherein the control unit is adapted for switching to the second circulation mode, which comprises stopping the fluid circulation, when a Doppler imaging mode and/or an elastography mode is activated.
