# US 10,368,893 B2 · Ultrasound transducer and uses thereof

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- Number: US 10,368,893 B2
- Document ID: US10368893B2
- Status: Granted
- Kind: B2
- Application number: 14/190,113
- Filed: 2014-02-26
- Published: 2014-06-26
- Granted: 2019-08-06
- Earliest claimed: 2010-10-18
- Assignees: CardioSonic Ltd.
- Applicants: CardioSonic Ltd.
- Inventors: Ariel Sverdlik; Or Shabtay
- Web page: https://patentgrep.com/patent/US10368893B2

## CPC

- A61B 17/320068: {using mechanical vibrations, e.g. ultrasonic (A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745)}
- A61B 17/2202: {the ultrasound transducer being inside patient's body at the distal end of the catheter}
- A61M 37/0092: {using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis}
- A61N 7/02: Localised ultrasound hyperthermia
- A61N 7/022: {intracavitary}
- A61B 2017/00106: {ultrasonic}
- A61B 2017/22008: {used or promoted}
- A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)}
- A61B 2017/22081: {Treatment of vulnerable plaque}
- A61B 2090/378: {using ultrasound}
- A61N 2007/0078: {with multiple treatment transducers}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- 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

According to some embodiments there is provided a method for controlling a treatment effect on blood vessel tissue during an ultrasonic treatment, the method comprising positioning an ultrasonic transducer device in the blood vessel lumen; controlling a treatment effect by controlling fluid flow, wherein controlling comprises deploying a fluid restrictor at a location relative to the transducer effective to block at least a portion of fluid flowing upstream, downstream or adjacent the transducer. According to some embodiments there is provided an ultrasonic transducer device sized for placement in a body lumen, and comprising a fluid restrictor effective to block at least a portion of fluid flowing upstream, downstream or adjacent the transducer. In some embodiments, the fluid is blood.

## Claims

### Claim 1

A method for controlling a treatment effect on blood vessel tissue during a non-focused ultrasonic treatment, comprising
positioning a non-focused ultrasonic transducer device which generates one or more non-focused ultrasonic beams with frequency in a range of 8 MHz-30 MHz for generating a treatment effect in target tissue outside of the inner wall of said blood vessel, said device positioned in the blood vessel lumen in a manner which prevents contact of said transducer with the inner wall, wherein said transducer faces said target tissue;
controlling said treatment effect by controlling fluid flow, wherein said controlling comprises deploying a fluid restrictor at a location relative to said transducer effective to block at least a portion of fluid flowing upstream, downstream or adjacent said transducer; and wherein said deployed fluid restrictor allows natural blood flow between said transducer and said inner wall of said blood vessel to cool said inner wall.

### Claim 2 (depends on 1)

The method according to claim 1, wherein said fluid is blood.

### Claim 3 (depends on 1)

The method according to claim 1, wherein said restrictor is deployed to block the flow upstream relative to said transducer device to load the vasa vasorum with a liquid material.

### Claim 4 (depends on 3)

The method according to claim 3, wherein said liquid material comprises micro bubbles to increase energy absorption in the target tissue.

### Claim 5 (depends on 1)

The method according to claim 1, wherein said restrictor is deployed to block the flow downstream relative to said transducer device to allow drug delivery to target tissue areas treated by said transducer device.

### Claim 6 (depends on 5)

The method according to claim 5, wherein said drug is one or more of:
restenosis prevention drug, anti-inflammatory drug, anti-thrombotic drug.

### Claim 7 (depends on 1)

The method according to claim 1, wherein said deploying comprises inflating a balloon.

### Claim 8 (depends on 1)

The method according to claim 1, wherein said fluid is a cooling fluid effective to cool said transducer device.

### Claim 9 (depends on 1)

The method according to claim 1, wherein said deploying comprises ensuring a fluid spacing between an irradiation face of said ultrasonic transducer device and target tissue.

### Claim 10 (depends on 1)

The method according to claim 1, wherein said treatment effect comprises cell necrosis.

### Claim 11 (depends on 1)

The method according to claim 1, further comprising estimating said treatment effect according to an echo received on said transducer.

### Claim 12 (depends on 1)

The method according to claim 1, wherein said controlling said treatment effect comprises controlling fluid flow according to real-time feedback from the tissue.

### Claim 13 (depends on 1)

The method according to claim 1, wherein said fluid restrictor blocks only a portion of fluid flowing downstream said transducer.

### Claim 14 (depends on 13)

The method according to claim 13, wherein a portion of said fluid flowing downstream which is not blocked by said fluid restrictor comprises said natural blood flow.

### Claim 15 (depends on 1)

The method according to claim 1, wherein said deployed fluid restrictor is in the form of a wire or a thin plastic sheet.

### Claim 16 (depends on 1)

The method according to claim 1, wherein said fluid restrictor is deployed at a location around said non-focused ultrasonic transducer device and allows natural blood flow on said non-focused ultrasonic transducer device outer surface.

### Claim 17 (depends on 1)

The method according to claim 1, wherein said non-focused ultrasonic transducer device is positioned at a distance from said inner wall of said blood vessel when generating said treatment effect while mechanically ensuring a liquid space between said inner wall and said transducer.

### Claim 18 (depends on 1)

The method according to claim 1, wherein said non-focused ultrasonic transducer device is flat.

### Claim 19 (depends on 1)

The method according to claim 1, further comprising treating said target by said one or more non-focused ultrasonic beams without affecting said inner wall of said blood vessel, and wherein said controlling comprising controlling fluid flow in said blood vessel during said treating.

### Claim 20 (depends on 19)

The method according to claim 19, wherein said target tissue is located at least 5 mm from said blood vessel lumen.

### Claim 21 (depends on 19, 20)

The method according to anyone of claim 19 or 20, wherein said target tissue comprises nerve tissue which resides outside of said blood vessel wall.

### Claim 22 (depends on 1)

The method according to claim 1, wherein said frequency is in the range of 10 MHz-30 MHz.

### Claim 23 (depends on 1)

The method according to claim 1, wherein said fluid restrictor is effective to block a portion of said fluid which is large enough so as to change said treatment effect.

### Claim 24 (depends on 1)

The method according to claim 1, wherein said inner wall of said blood vessel comprises the intima, and said target tissue comprises at least one of the media and adventitia of said blood vessel.

### Claim 25

A non-focused ultrasonic transducer device comprising:
a non-focused flat piezoelectric transducer configured to generate one or more non-focused ultrasonic beams and sized for placement in a body lumen in which blood naturally flows, wherein said piezoelectric transducer is configured to be placed in said body lumen in a manner which prevents contact of said piezoelectric transducer with the inner wall of said body lumen, wherein said transducer faces target tissue located outside of the inner wall of said body lumen;
a controller which electrifies said piezoelectric transducer to generate a non-focused ultrasonic power beam with frequency in a range of 8 MHz-30 MHz, total energy and for a time period suitable for treating said target tissue; a power unit enabling said ultrasonic power beam for tissue ablation; and
a fluid restrictor effective to block at least a portion of fluid flowing upstream, downstream, or adjacent said piezoelectric transducer; wherein said fluid restrictor, when deployed, is shaped and positioned to allow at least some of said natural flow of blood between said transducer and said inner wall of said body lumen to cool said inner wall enough to prevent thermal damage to said inner wall.

### Claim 26 (depends on 25)

The device according to claim 25, wherein said fluid restrictor is a balloon.

### Claim 27 (depends on 25)

The device according to claim 25, wherein said fluid restrictor is a wire, a net, or a thin sheet.

### Claim 28 (depends on 25)

The device according to claim 25, wherein said device further comprises a control unit configured to activate deployment of said fluid restrictor.

### Claim 29 (depends on 28)

The device according to claim 28, wherein said device further comprises a flow sensor, and said control unit is configured to monitor fluid flow in the region of treatment based on an indication from said flow sensor.

### Claim 30 (depends on 25)

The device according to claim 25, further comprising a perfusion unit configured for ejecting substances into the vessel.

### Claim 31 (depends on 25)

The device according to claim 25, wherein said fluid restrictor serves as a placing element for positioning said transducer in the vessel.

### Claim 32 (depends on 25)

The device according to claim 25, wherein said device further comprises a temperature sensor and said fluid restrictor is positioned to allow the sensor to detect a temperature of fluid flowing passed said transducer.

### Claim 33 (depends on 25)

The device according to claim 25, wherein said piezoelectric transducer is protected by a housing, said housing shaped to affect fluid flow within a lumen around said piezoelectric transducer.

### Claim 34 (depends on 25)

The device according to claim 25, wherein said fluid restrictor blocks only a portion of fluid flowing downstream said transducer to allow for at least some of said natural flow of blood between said transducer and an inner wall of said body lumen.

### Claim 35 (depends on 25)

The device according to claim 25, wherein said fluid restrictor is shaped and positioned to (1) restrict blood flow on said non-focused flat piezoelectric transducer, and to (2) prevent contact of said non-focused flat piezoelectric transducer with said inner wall of said body lumen.

### Claim 36 (depends on 25)

The device according to claim 25, wherein said frequency is in the range of 10 MHz-30 MHz.

### Claim 37

A method for controlling a treatment effect on blood vessel tissue during an ultrasonic treatment, comprising
positioning an ultrasonic transducer device in the blood vessel lumen, wherein said transducer faces target tissue located outside of an inner wall of said blood vessel;
treating said target tissue by one or more non-focused ultrasonic beams with a frequency in a range of 10 MHz-30 MHz for generating a treatment effect, generated by said ultrasonic transducer without damaging a surface of said inner wall;
controlling a treatment effect by controlling fluid flow, wherein said controlling comprises deploying a fluid restrictor in the form of a wire or a thin plastic sheet, at a location relative to said transducer effective to block at least a portion of fluid flowing upstream, downstream or adjacent said transducer; wherein said deployed fluid restrictor allows natural blood flow between said transducer and said inner wall of said blood vessel to cool said innerwall; and
monitoring said fluid flow using a flow sensor.

### Claim 38

A method for controlling a treatment effect on blood vessel tissue during an ultrasonic treatment, comprising
positioning an ultrasonic transducer device in the blood vessel lumen, wherein said transducer faces target tissue located outside of an inner wall of said blood vessel;
treating said target tissue by one or more non-focused ultrasonic beams with a frequency in a range of 10 MHz-30 MHz for generating a treatment effect, generated by said ultrasonic transducer without damaging a surface of said inner wall; and
controlling a treatment effect by controlling fluid flow, wherein said controlling comprises deploying a fluid restrictor at a location around said transducer effective to block at least a portion of fluid flowing upstream, downstream or adjacent said transducer; and wherein said deployed fluid restrictor allows natural blood flow between said transducer and said inner wall of said blood vessel to cool said inner wall.

### Claim 39

A method for controlling a treatment effect on blood vessel tissue during an ultrasonic treatment, comprising
positioning a non-focused ultrasonic transducer device in the blood vessel lumen, at a distance from an inner wall of said blood vessel, wherein said transducer faces target tissue outside of said inner wall of said blood vessel, while mechanically ensuring a liquid space between said inner wall and said non-focused ultrasonic transducer device;
treating said target tissue by one or more non-focused ultrasonic beams with a frequency in a range of 10 MHz-30 MHz generated by said non-focused ultrasonic transducer without damaging a surface of said inner wall; and
controlling a treatment effect by controlling fluid flow, wherein said controlling comprises deploying a fluid restrictor at a location relative to said transducer effective to block at least a portion of fluid flowing upstream, downstream or adjacent said transducer; and wherein said deployed fluid restrictor allows natural blood flow between said transducer and said inner wall of said blood vessel to cool said inner wall.
