# US 12,179,041 B2 · Apparatus, system, and method for mechanical ablation with therapeutic ultrasound

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- Number: US 12,179,041 B2
- Document ID: US12179041B2
- Status: Granted
- Kind: B2
- Application number: 16/809,732
- Filed: 2020-03-05
- Published: 2020-09-10
- Granted: 2024-12-31
- Earliest claimed: 2019-03-06
- Assignees: The University of Chicago
- Applicants: The University of Chicago
- Inventors: Kenneth B. Bader; Viktor Bollen
- Web page: https://patentgrep.com/patent/US12179041B2

## CPC

- 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})
- A61N 7/02: Localised ultrasound hyperthermia
- A61B 8/0833: {involving detecting or locating foreign bodies or organic structures}
- A61B 8/085: {for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules}
- A61B 8/14: Echotomography
- A61B 8/481: {involving the use of contrast agents, e.g. microbubbles introduced into the bloodstream}
- A61N 2007/0004: {Applications of ultrasound therapy}
- A61N 2007/0039: {using microbubbles}
- A61N 2007/0052: {using the same transducer for therapy and imaging}
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

This disclosure describes devices, systems, and methods related to therapeutic ultrasound. An exemplary system includes a transducer configured to emit therapy ultrasound waves towards a therapy site and an ultrasound imaging device configured to emit plane wave ultrasound waves towards the therapy site. The system further includes a controller coupled to the transducer and the ultrasound imaging device. The controller is configured to send an activation signal to the transducer and send an activation signal to the ultrasound imaging device. The controller is further configured to receive image data from the ultrasound imaging device and generate bubble cloud image data based on the received image data.

## Claims

### Claim 1

A therapeutic ultrasound system comprising:
a transducer configured to emit therapy ultrasound waves towards a therapy site;
an ultrasound imaging device configured to emit pulse inversion plane wave ultrasound waves or chirp-coded excitation plane wave ultrasound waves towards the therapy site and having a focus area of 2-4 centimeters, wherein the ultrasound imaging device is configured to operate in a B-mode and a plurality of image elements emit at a first time and detect at a second time; and
a controller coupled to the transducer and the ultrasound imaging device, the controller configured to:
send an activation signal to the transducer to cause application of the therapy ultrasound waves towards the therapy site;
send an activation signal to the ultrasound imaging device to cause the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves to begin to be applied i) simultaneously with a last pulse of the therapy ultrasound waves, or ii) at least 5 microseconds (μs) after a start of the last pulse of the therapy ultrasound waves and less than 179 us after the start of the last pulse of the therapy ultrasound waves;
receive image data from the ultrasound imaging device; and
generate bubble cloud image data based on the received image data.

### Claim 2 (depends on 1)

The therapeutic ultrasound system of claim 1, wherein the therapy ultrasound waves are configured to generate bubbles at the therapy site and, wherein the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves are configured to cause the bubbles to diffuse into tissue of the therapy site.

### Claim 3 (depends on 1)

The therapeutic ultrasound system of claim 1, wherein the controller is further configured to calculate bubble deletion during a treatment session based on the bubble cloud image data, wherein the controller is further configured to adjust one or more parameters of the transducer, the ultrasound imaging device, or both, based on the calculated bubble deletion, and wherein the treatment session includes multiple cycles of the therapy ultrasound waves and the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves interleaved together.

### Claim 4 (depends on 1)

The therapeutic ultrasound system of claim 1, wherein the transducer is arranged orthogonal to the ultrasound imaging device such that a focus direction of the transducer is orthogonal to a focus direction of the ultrasound imaging device, and wherein the ultrasound imaging device is aligned confocally with the transducer.

### Claim 5 (depends on 1)

The therapeutic ultrasound system of claim 1, wherein the ultrasound imaging device comprises a plane wave B-mode device, and wherein the ultrasound imaging device is further configured to:
receive a backscatter signal generated based on the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves; and
generate the image data based on the backscatter signal.

### Claim 6 (depends on 1)

The therapeutic ultrasound system of claim 1, wherein the therapy ultrasound waves comprise pulses and have a pulse length of 3-40 μs, wherein an exposure time of pulses of the therapy ultrasound waves is 5-60 ms, or both.

### Claim 7 (depends on 6)

The therapeutic ultrasound system of claim 6, wherein a fundamental frequency of the therapy ultrasound waves is 800 kHz to 1200 kHz, wherein a pulse repetition frequency of the pulses of the therapy ultrasound waves is 10-30 Hertz, or both.

### Claim 8 (depends on 1)

The therapeutic ultrasound system of claim 1, wherein a peak negative pressure of the therapy ultrasound waves is 10-20 MPa, a derated focal peak negative pressure of the therapy ultrasound waves is 10-30 MPa, a derated peak positive pressure of the therapy ultrasound waves is 50-150 MPa, a peak negative pressure of the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves is 300 kPA to 10 MPa, or a combination thereof.

### Claim 9 (depends on 1)

The therapeutic ultrasound system of claim 1, wherein the activation signal is configured to cause the ultrasound imaging device to emit the pulse inversion plane wave ultrasound waves, wherein a fundamental frequency of the pulse inversion plane wave ultrasound waves is about 5 MHz, and wherein a pulse duration of the pulse inversion plane wave ultrasound waves is 0.3 μs.

### Claim 10 (depends on 1)

The therapeutic ultrasound system of claim 1, wherein a frame rate of the ultrasound imaging device is about 2 kHz, wherein the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves are applied 147 μs to 179 μs after the start of the last pulse of the therapy ultrasound waves, and wherein a treatment session includes multiple therapy cycles and the last pulse is a last pulse of a particular therapy cycle of the multiple therapy cycles.

### Claim 11 (depends on 1)

The therapeutic ultrasound system of claim 1, wherein the activation signal is configured to cause the ultrasound imaging device to emit the chirp-coded plane wave ultrasound excitation waves, wherein a pulse bandwidth of the chirp-coded excitation plane wave ultrasound waves is between 4.8 to 6 MHz, and wherein an application duration of the chirp-coded plane wave ultrasound excitation waves is 2 μs.

### Claim 12 (depends on 1)

A method performed by the therapeutic ultrasound system of claim 1, the method comprising:
applying therapy ultrasound waves towards a therapy site;
applying pulse inversion plane wave ultrasound waves or chirp-coded excitation plane wave ultrasound waves towards the therapy site and with a focus area of 2-4 centimeters, wherein the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves are applied i) simultaneously with a last pulse of the therapy ultrasound waves, or ii) at least 5 microseconds (μs) after a start of the last pulse of the therapy ultrasound waves and less than 179 μs after the start of the last pulse of the therapy ultrasound waves;
receiving, a backscatter signal from the therapy site based on the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves;
generating image data based on the backscatter signal; and
outputting the image data based on the backscatter signal.

### Claim 13 (depends on 12)

The method of claim 12, further comprising:
applying second pulse inversion plane wave ultrasound waves or second chirp-coded excitation plane wave ultrasound waves towards the therapy site, wherein the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves have a higher frequency than the second pulse inversion plane wave ultrasound waves or the second chirp-coded excitation plane wave ultrasound waves, and wherein the second pulse inversion plane wave ultrasound waves or the second chirp-coded excitation plane wave ultrasound waves are applied after the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves;
generating second image data based on a second backscatter signal based on the second pulse inversion plane wave ultrasound waves or the second chirp-coded excitation plane wave ultrasound waves; and
calculating bubble deletion parameters based on the image data and the second image data.

### Claim 14 (depends on 13)

The method of claim 13, wherein i) the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves are applied 10 μs to 179 μs after the therapy ultrasound waves; ii) the second pulse inversion plane wave ultrasound waves or the second chirp-coded excitation plane wave ultrasound waves are applied 10 ms after the therapy ultrasound waves; iii) multiple backscatter signals are received over a 10-50 ms imaging period based on a plurality of pulses of the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves and a plurality of pulses of the second pulse inversion plane wave ultrasound waves or the second chirp-coded excitation plane wave ultrasound waves; iv) the method further comprises generating multiple frames of image data based on the multiple backscatter signals; or a combination thereof.

### Claim 15 (depends on 12)

The method of claim 12, further comprising:
brightness mode converting the image data to generate a grayscale bubble cloud image; and
binarize converting the grayscale bubble cloud image to generate a binarized bubble cloud image.

### Claim 16 (depends on 1)

The therapeutic ultrasound system of claim 1, wherein the ultrasound imaging device is further configured to emit second plane wave ultrasound waves towards the therapy site, the second plane wave ultrasound waves having a second frequency different from a first frequency of the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves, wherein the controller is further configured to send an activation signal to the ultrasound imaging device to cause the second plane wave ultrasound waves to be applied 10 milliseconds after the start of the last pulse of the therapy ultrasound waves.

### Claim 17 (depends on 1)

The therapeutic ultrasound system of claim 1, wherein the therapy ultrasound waves comprise pulses and have a pulse length of 3-9 μs, wherein a fundamental frequency of the therapy ultrasound waves is 800 kHz to 1100 kHz, wherein a pulse repetition frequency of the pulses of the therapy ultrasound waves is 10-30 Hertz, or a combination thereof.

### Claim 18 (depends on 1)

The therapeutic ultrasound system of claim 1, wherein the controller is further configured to:
send an activation signal to the transducer to cause application of second therapy ultrasound waves towards the therapy site, wherein the therapy ultrasound waves are part of a first cycle of a treatment session and the second therapy ultrasound waves are part of a second cycle of the treatment session;
send a second activation signal to the ultrasound imaging device to cause second pulse inversion plane wave ultrasound waves or second chirp-coded excitation plane wave ultrasound waves to begin to be applied i) simultaneously with a last pulse of the second therapy ultrasound waves, or ii) at least 5 microseconds (μs) after a start of the last pulse of the second therapy ultrasound waves and less than 179 microseconds (μs) after i) simultaneously with a last pulse of the second therapy ultrasound waves, or ii) at least 5 microseconds (μs) after a start of the last pulse of the second therapy ultrasound waves and a start of a last pulse of the second therapy ultrasound waves;
receive second image data from the ultrasound imaging device corresponding to the second pulse inversion plane wave ultrasound waves or the second chirp-coded excitation plane wave ultrasound waves;
generate second bubble cloud image data based on the received second image data;
calculate bubble deletion based on the bubble cloud image data and the second bubble cloud image data; and
adjust one or more parameters of the transducer, the ultrasound imaging device, or both, based on the calculated bubble deletion.

### Claim 19 (depends on 1)

The therapeutic ultrasound system of claim 1, wherein the activation signal sent to the ultrasound imaging device causes the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves to begin to be applied simultaneously with the last pulse of the therapy ultrasound waves.

### Claim 20 (depends on 1)

The therapeutic ultrasound system of claim 1, wherein the activation signal sent to ultrasound imaging device causes the pulse inversion plane wave ultrasound waves or the chirp-coded excitation plane wave ultrasound waves to begin to be applied at least 5 μs after the start of the last pulse of the therapy ultrasound waves and less than 179 μs after the start of the last pulse of the therapy ultrasound waves.
