# US 10,945,660 B2 · Normalized-displacement-difference-based approach for thermal lesion size control

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- Number: US 10,945,660 B2
- Document ID: US10945660B2
- Status: Granted
- Kind: B2
- Application number: 15/125,598
- Filed: 2015-03-18
- Published: 2017-01-12
- Granted: 2021-03-16
- Earliest claimed: 2014-03-27
- Assignees: Koninklijke Philips N.V.
- Applicants: Koninklijke Philips N.V.
- Inventors: Sheng-Wen Huang; Ajay Anand; Shriram Sethuraman
- Web page: https://patentgrep.com/patent/US10945660B2

## CPC

- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 8/08: Clinical applications (A61B8/02, A61B8/04, A61B8/06 take precedence)
- A61B 8/4483: {characterised by features of the ultrasound transducer}
- A61B 8/485: {involving measuring strain or elastic properties}
- A61B 18/12: by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61N 7/02: Localised ultrasound hyperthermia
- G05B 19/042: using digital processors (G05B19/05 takes precedence)
- A61B 8/4488: {the transducer being a phased array}
- A61B 2017/00106: {ultrasonic}
- A61B 2018/00636: {Sensing and controlling the application of energy}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00666: {using a threshold value}
- A61B 2090/378: {using ultrasound}
- A61B 2505/05: Surgical care
- 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)
- G05B: CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS (systems for controlling or regulating non-electric variables G05D; systems for regulating electric or magnetic variables G05F; control devices or systems insofar as characterised by mechanical features only G05G)

## Abstract

The present invention relates to monitoring biological tissue during a delivery of energy. A probe-driving unit repeatedly drives an integrated push-and-track transducer unit, which is external to the control device, in repeatedly providing at least one ultrasonic push pulse (302) that is suitable for displacing biological tissue at a monitoring location (M), and in providing ultrasonic track pulses (301, 303) suitable for detecting tissue displacement occurring in response to the push pulse at the monitoring location, and in detecting and delivering ultrasonic tissue-response signals (R) relating to the track pulses. An evaluation unit receives the tissue-response signals, determines in real time whether a normalized displacement quantity has reached a threshold value, and provides an output signal when the threshold value has been reached.

## Claims

### Claim 1

A tissue-monitoring device for monitoring biological tissue in a monitoring session during a delivery of energy to the biological tissue, comprising:
a memory that stores instructions, and
a processor that executes the instructions, wherein, when executed by the processor, the instructions cause the tissue-monitoring device to implement a process comprising:
providing probe-driving signals suitable for driving an integrated push-and-track transducer of a measurement probe, which is external to the tissue-monitoring device, to repeatedly provide at least one ultrasonic push pulse that is suitable for displacing biological tissue at a monitoring location, to provide ultrasonic track pulses suitable for detecting tissue displacement occurring in response to the ultrasonic push pulse at the monitoring location, and to detect and deliver ultrasonic tissue-response signals relating to the ultrasonic track pulses;
repeatedly determining in real time during the monitoring session based on the ultrasonic tissue-response signals: a current value of a displacement quantity indicative of an amount of tissue displacement detected, a current maximum of the displacement quantity since a beginning of the monitoring session, a ratio between the current value and the current maximum of the displacement quantity, a normalized displacement quantity that uses the ratio between the current value and the current maximum of the displacement quantity, and whether the normalized displacement quantity has reached a threshold value; and
providing an output signal when the threshold value has been reached.

### Claim 2 (depends on 1)

The tissue-monitoring device of claim 1, wherein, when executed by the processor, the instructions further cause the tissue-monitoring device to:
receive a control input indicative of a desired spatial extension of a planned tissue ablation zone at a planned location of energy delivery,
determine, from the control input, the monitoring location at a peripheral location (P) of the planned tissue ablation zone, and
determine the threshold value of the normalized displacement quantity in dependence on the determined monitoring location.

### Claim 3 (depends on 1)

The tissue-monitoring device of claim 1, wherein, when executed by the processor, the instructions further cause the tissue-monitoring device:
to determine the normalized displacement quantity as a normalized displacement difference according to
NDD(t)=1−ND(t),
wherein
ND
⁡
(
t
)
=
D
⁡
(
t
)
D
max
⁡
(
t
)
,
t is a time difference with respect to a beginning of the monitoring session,
ND(t) is the current value of the normalized displacement,
D(t) is the current value of the displacement quantity,
Dmax(t) is the current maximum of the displacement quantity detected during the monitoring session, and
NDD(t) is the normalized displacement difference, and
to determine from the determined normalized displacement difference an extension of a planned tissue ablation zone using a calibration function with prestored calibration parameters.

### Claim 4 (depends on 3)

The tissue-monitoring device of claim 3, wherein the calibration function defines the extension of the planned tissue ablation zone with two calibration parameters as a linear function of the normalized displacement difference or with three calibration parameters as a quadratic function of the normalized displacement difference.

### Claim 5 (depends on 4)

The tissue-monitoring device of claim 4, wherein, when executed by the processor, the instructions further cause the tissue-monitoring device to receive a desired spatial extension of a planned tissue ablation zone in the biological tissue, and to determine, using the calibration function, a threshold value of the normalized displacement difference for a given desired spatial extension of the planned tissue ablation zone.

### Claim 6 (depends on 1)

The tissue monitoring device of claim 1, wherein, when executed by the processor, the instructions further cause the tissue-monitoring device to drive the push-and-track transducer in providing a first ultrasonic track pulse before providing the ultrasonic push pulse and a second ultrasonic track pulse after providing the ultrasonic push pulse.

### Claim 7 (depends on 1)

A tissue-monitoring system, comprising:
a tissue monitoring device of claim 1; and
a measurement probe, which is configured to receive the probe-driving signals and to deliver the ultrasonic tissue-response signal and which comprises an integrated push-and-track transducer configured to provide the at least one ultrasonic push pulse and the ultrasonic track pulses, and which is configured to detect the ultrasonic tissue-response signals relating to the ultrasonic track pulses.

### Claim 8 (depends on 7)

An energy-delivery system for delivering energy to biological tissue, comprising:
an energy-delivery probe, which is configured to deliver energy in an energy amount suitable for necrosing tissue to a desired ablation zone of the tissue when positioned at a delivery location; and
a tissue-monitoring system according to claim 7;
wherein the energy-delivery system is configured to receive the output signal provided by the tissue-monitoring device and to stop delivering energy upon reception of the output signal.

### Claim 9 (depends on 7)

The tissue-monitoring device of claim 7, wherein the measurement probe comprises a single integrated-push-and-track transducer for the delivery of both, the at least one ultrasonic push pulse and the ultrasonic track pulses, and which is configured to detect and deliver the ultrasonic tissue-response signals.

### Claim 10 (depends on 1)

An energy-delivery system for delivering energy to biological tissue, comprising:
an energy-delivery probe, which is configured to deliver energy in an energy amount suitable for necrosing tissue to a desired ablation zone of the tissue when positioned at a delivery location; and
a tissue-monitoring device according to claim 1;
wherein the energy-delivery system is configured to receive the output signal provided by the tissue-monitoring device and to stop delivering energy upon reception of the output signal.

### Claim 11 (depends on 1)

The tissue monitoring device of claim 1, wherein the current maximum of the displacement quantity is increased from a first current maximum of the displacement quantity to a second current maximum of the displacement quantity during the monitoring session based on detecting a current value of the displacement quantity equal to the second current maximum of the displacement quantity and greater than the first current maximum of the displacement quantity.

### Claim 12

A monitoring method for monitoring biological tissue in a monitoring session during a delivery of energy to the biological tissue, comprising:
providing, from a tissue-monitoring device, probe-driving signals suitable for driving an integrated push-and-track transducer of a measurement probe, which is external to the tissue-monitoring device, in repeatedly providing at least one ultrasonic push pulse that is suitable for displacing biological tissue at a monitoring location, and in providing ultrasonic track pulses suitable for detecting tissue displacement occurring in response to the ultrasonic push pulse at the monitoring location, and suitable for detecting and delivering ultrasonic tissue-response signals relating to the ultrasonic track pulses;
repeatedly determining from the ultrasonic tissue-response signals in real time and based on the ultrasonic tissue-response signals: a current value of a displacement quantity, which is indicative of an amount of tissue displacement detected; a current maximum of the displacement quantity since a beginning of the monitoring session; a ratio between the value of the displacement quantity and the current maximum of the displacement quantity; a current value of a normalized displacement quantity, which uses the ratio between the value of the displacement quantity and the current maximum of the displacement quantity, and whether the normalized displacement quantity has reached a predetermined threshold value of the normalized displacement quantity; and
providing an output signal when the predetermined threshold value of the normalized displacement quantity has been reached.

### Claim 13 (depends on 12)

The method of claim 12, further comprising:
receiving a control input indicative of a desired spatial extension of a planned tissue ablation zone at a planned location of energy delivery;
determining, from the control input, a monitoring location at a peripheral location of the planned tissue ablation zone; and
determining, in dependence on the determined monitoring location, the threshold value of the normalized displacement quantity.

### Claim 14 (depends on 12)

The method of claim 12, further comprising,
determining the normalized displacement quantity as a normalized displacement difference according to
NDD(t)=1−ND(t),
wherein
ND
⁡
(
t
)
=
D
⁡
(
t
)
D
max
t is a time difference with respect to a beginning of the monitoring session
ND(t) is the current value of the normalized displacement,
D(t) is the current value of the displacement quantity,
Dmax is the current maximum of the displacement quantity detected during the monitoring session, and
NDD(t) is the normalized displacement difference; and
determining from the determined normalized displacement difference an extension of a planned tissue ablation zone using a calibration function with prestored calibration parameters.

### Claim 15 (depends on 10)

A method for delivering energy to biological tissue, comprising
delivering energy in an energy amount suitable for necrosing tissue to a desired ablation zone of the tissue via an energy-delivery probe positioned at a delivery location;
performing a monitoring session for monitoring the tissue according to the method of claim 10, and
ending the delivery of energy when the output signal has been provided.

### Claim 16 (depends on 12)

The method of claim 12, wherein the method is implemented when a computer executes a tissue-monitoring control computer program to cause the computer to carry out the method when the computer program is executed on the computer.

### Claim 17 (depends on 15)

The method of claim 15, wherein the method is implemented when a computer executes an energy-delivery control program to cause the computer to carry out the method when the computer program is executed on a computer.

### Claim 18 (depends on 12)

The method of claim 12,
wherein the current maximum of the displacement quantity is increased from a first current maximum of the displacement quantity to a second current maximum of the displacement quantity during the monitoring session based on detecting a current value of the displacement quantity equal to the second current maximum of the displacement quantity and greater than the first current maximum of the displacement quantity.

### Claim 19 (depends on 18)

The method of claim 18, further comprising:
determining the normalized displacement quantity based on the second current maximum of the displacement quantity; and
determining whether the normalized displacement quantity has reached the predetermined threshold value of the normalized displacement quantity after determining the normalized displacement quantity based on the second current maximum of the displacement quantity.