# US 11,998,766 B2 · Medical device with CMUT array and solid state cooling, and associated methods and systems

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- Number: US 11,998,766 B2
- Document ID: US11998766B2
- Status: Granted
- Kind: B2
- Application number: 17/479,011
- Filed: 2021-09-20
- Published: 2022-03-10
- Granted: 2024-06-04
- Earliest claimed: 2017-09-13
- Assignees: Ultra HOM, LLC
- Applicants: Ultra HOM LLC
- Inventors: Arif Sanli Ergun; Andre Khoury; Butrus T. Khuri-Yakub; John N. Irwin, III
- Web page: https://patentgrep.com/patent/US11998766B2

## CPC

- A61N 7/022: {intracavitary}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 8/488: {involving Doppler signals}
- A61B 17/22004: {using mechanical vibrations, e.g. ultrasonic shock waves (A61B17/225 takes precedence)}
- A61B 17/2202: {the ultrasound transducer being inside patient's body at the distal end of the catheter}
- A61B 18/02: by cooling, e.g. cryogenic techniques
- B06B 1/0292: {Electrostatic transducers, e.g. electret-type}
- A61B 2018/00047: {using Peltier effect}
- A61B 2018/00547: {Prostate}
- A61B 2018/00577: {Ablation}
- A61B 2018/00791: {Temperature}
- A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61N 2007/0004: {Applications of ultrasound therapy}
- A61N 2007/0043: {intra-cavitary}
- A61N 2007/0078: {with multiple treatment transducers}
- 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)
- B06B: METHODS OR APPARATUS FOR GENERATING OR TRANSMITTING MECHANICAL VIBRATIONS OF INFRASONIC, SONIC, OR ULTRASONIC FREQUENCY, {e.g.} FOR PERFORMING MECHANICAL WORK IN GENERAL (for particular applications, see the relevant subclasses, e.g. B07B1/40, B23Q17/12, B24B31/06; measurement of mechanical vibrations G01H; in direction finding, locating, distance or velocity measuring G01S; {generating seismic energy G01V1/02}; control of mechanical vibrations in general G05D; sound-producing devices, e.g. bells, sirens, whistles G10K, {e.g. methods or devices for transmitting, conducting, or directing sound in general G10K11/00}; generation of electrical oscillations H03B; electromechanical resonators in general H03H; electromechanical transducers {for communication techniques, e.g. microphones, speakers} H04R)

## Abstract

A medical device includes a capacitive micromachined ultrasonic transducer (CMUT) array configured to emit ultrasound to target tissue, and at least one thermoelectric cooler mechanically coupled with the CMUT array and configured to cool non-target tissue heated by the ultrasound. The medical device may be implemented in a catheter together with a solid thermal conductor coupled to the thermoelectric cooler and extending along the catheter, to conduct heat away from the thermoelectric cooler. A catheter or catheter sleeve includes a tubular wall for insertion into a body channel, and at least one thermoelectric cooler coupled to the tubular wall for cooling the body channel wall. A catheter sleeve includes tubular casing for insertion into a body channel and capable of encasing a catheter, and at least one sensor coupled to the tubular casing for sensing one or more properties of the body channel wall, such as temperature and pressure.

## Claims

### Claim 1

A method of treating tissue, comprising the steps of:
providing a catheter for ultrasound treatment with solid state cooling, comprising:
a distal end configured to be disposed within a body channel during operation of the catheter;
a proximal end configured to remain outside the body channel during said operation;
a capacitive micromachined ultrasonic transducer (CMUT) array disposed at a distal end of the catheter and configured to emit ultrasound to target tissue; and
a thermoelectric cooler disposed at the distal end and having opposed first and second sides, wherein during operation of the catheter the first side of the thermoelectric cooler is in thermal contact with non-target tissue to cool the non-target tissue and the second side of the thermoelectric cooler is coupled to a solid thermal conductor that conducts heat away from the thermoelectric cooler; and
positioning the catheter within a body channel.

### Claim 2 (depends on 1)

The method of claim 1, the thermoelectric cooler being mechanically coupled with the CMUT array.

### Claim 3 (depends on 1)

The method of claim 1, the catheter further comprising a temperature sensor for sensing temperature of the non-target tissue, the temperature sensor being disposed at the distal end.

### Claim 4 (depends on 1)

The method of claim 1, the catheter further comprising a pressure sensor for sensing pressure of the non-target tissue, the pressure sensor being disposed at the distal end.

### Claim 5 (depends on 1)

The method of claim 1, the catheter being configured for insertion into a urethra, the target tissue being a prostate, the non-target tissue being at least a portion of wall of the urethra.

### Claim 6 (depends on 5)

The method of claim 5, further comprising implementing the CMUT array and the thermoelectric cooler in a catheter tip, and the catheter further comprising a catheter jacket coupled to the catheter tip and having length to reach from the prostate to an exit of the urethra.

### Claim 7 (depends on 6)

The method of claim 6, the catheter jacket including a thermally insulating layer for preventing the heat conducted by the solid thermal conductor from damaging the wall of the urethra.

### Claim 8 (depends on 6)

The method of claim 6, the catheter further comprising a removable sleeve disposed about the catheter tip and the catheter jacket, the removable sleeve including an inflatable balloon for securing the removable sleeve to a bladder and having length to at least reach from the bladder to the exit of the urethra and being configured to remain in the urethra for a duration after extraction of the catheter tip from the urethra.

### Claim 9 (depends on 8)

The method of claim 8, the removable sleeve further including a thermally insulating layer for preventing the heat conducted by the solid thermal conductor from damaging the wall of the urethra.

### Claim 10

A method for ultrasound treatment with solid state cooling, comprising the steps of:
exposing target tissue to ultrasound generated by a capacitive micromachined ultrasonic transducer (CMUT) array, said exposing comprising generating the ultrasound from within a body channel, the CMUT array having been advanced to the target tissue on a catheter through the body channel; and
to prevent damage to a wall of the body channel, cooling the wall with one or more thermoelectric coolers disposed within the body channel coupled to at least one of the CMUT array and the catheter, a thermoelectric cooler of the one or more thermoelectric coolers having opposed first and second sides, wherein during operation of the catheter the first side of the thermoelectric cooler is in thermal contact with non-target tissue to cool the non-target tissue and the second side of the thermoelectric cooler is coupled to a solid thermal conductor that conducts heat away from the thermoelectric cooler.

### Claim 11 (depends on 10)

The method of claim 10, further comprising:
in the step of exposing, exposing a prostate to the ultrasound from a urethra; and in the step of cooling, cooling wall of the urethra.

### Claim 12 (depends on 10)

The method of claim 10, further comprising:
monitoring temperature of the wall; and
in the step of exposing, adjusting exposure of the target tissue to the ultrasound according to the temperature.

### Claim 13 (depends on 12)

The method of claim 12, the step of adjusting comprising at least temporarily ceasing said exposing when the temperature exceeds a threshold temperature.

### Claim 14 (depends on 10)

The method of claim 10, further comprising:
monitoring pressure of the wall; and
in the step of exposing, adjusting exposure of the target tissue to the ultrasound according to the pressure.
