WO2024139720A1 - Ultrasound therapy device - Google Patents

Abstract

An ultrasound therapy device, belonging to the technical field of ultrasound therapy. The ultrasound therapy device comprises a plurality of ultrasonic emission units, a plurality of detection units, and a control module. The plurality of ultrasonic emission units are used for emitting an ultrasonic wave to a focus. The detection units are in one-to-one correspondence with the ultrasonic emission units. Each detection unit is arranged at the ultrasonic emission unit corresponding thereto. The control module is used for controlling the ultrasonic emission units and the detection units to carry out the following working processes: emitting, by each ultrasonic emission unit, an excitation ultrasonic wave by taking a to-be-treated position as a focus, and recording, by each detection unit, infrasonic wave parameters of received infrasonic waves; determining, according to predetermined focal region parameters and the infrasonic wave parameters, a target parameter of a therapeutic ultrasonic wave emitted by each ultrasonic emission unit; and emitting, by each ultrasonic emission unit, the therapeutic ultrasonic wave according to the target parameter by taking said position as the focus.

Description

Ultrasound therapy equipment Technical Field

The invention belongs to the technical field of ultrasonic therapy, and in particular relates to an ultrasonic therapy device.

Background technique

High Intensity Focused Ultrasound (HIFU) technology refers to a technology that focuses ultrasound waves emitted by multiple ultrasound transmitting units (such as array elements) at a focus (target point), thereby generating high-intensity ultrasound waves near the focus (focal area). For example, ultrasound waves can be focused on the tissue to be treated in the human body to treat the tissue to be treated (such as deforming the diseased tissue), which is ultrasound therapy.

Precisely controlling the size, shape, and energy of the focal area is important for improving the treatment effect, and this requires that the ultrasound waves emitted by each ultrasound transmitting unit simultaneously reach the required phase, amplitude, and other parameters at the focal point. However, the change in ultrasound parameters is related to the acoustic medium it passes through, and the human body is a complex, non-uniform acoustic medium. Therefore, the acoustic medium conditions of ultrasound waves emitted by different ultrasound transmitting units in the human body are different and difficult to predict, so it is very difficult to ensure that the ultrasound waves emitted by each ultrasound transmitting unit simultaneously reach the required parameters at the focal point.

Summary of the invention

The present invention at least partially solves the problem that the existing ultrasonic treatment equipment cannot accurately control the size, shape and energy of the focal area, and provides an ultrasonic treatment equipment that can more accurately control the size, shape and energy of the focal area.

In a first aspect, an embodiment of the present invention provides an ultrasonic treatment device, which includes a plurality of ultrasonic transmitting units, a plurality of detection units, and a control module;

The plurality of ultrasound transmitting units are used to emit ultrasound waves toward a focus;

The detection units correspond to the ultrasonic transmitting units one by one, and each detection unit is arranged at the corresponding ultrasonic transmitting unit;

The control module is used to control the ultrasonic transmitting unit and the detection unit to perform the following work flow:

Each of the ultrasonic emitting units emits an excitation ultrasonic wave with the position to be treated as the focus, and each of the detecting units records the infrasound wave parameters of the received secondary sound waves; the excitation ultrasonic wave can excite the tissue at the focus to vibrate and emit the secondary sound waves;

Determining target parameters of the therapeutic ultrasound waves emitted by each of the ultrasound transmitting units according to the predetermined focal zone parameters and the infrasound wave parameters; the therapeutic ultrasound waves can treat tissues at the focal point;

Each of the ultrasound transmitting units takes the position to be treated as a focus and emits the therapeutic ultrasound according to the target parameters.

Optionally, the ultrasonic transmitting unit and the corresponding detection unit are an integrated structure.

Optionally, the focal area parameters include at least one of shape, size, and energy of the focal area.

Optionally, the infrasound wave parameter includes at least one of a receiving time of the secondary sound wave and an amplitude of the secondary sound wave.

Optionally, the target parameter includes at least one of the phase and amplitude of the therapeutic ultrasound.

Optionally, the focal area parameters include the shape and size of the focal area;

The infrasound wave parameters include a receiving time when the secondary sound wave is received;

The target parameters include the phase of the therapeutic ultrasound waves;

Among them, the earlier the detected receiving time is, the later the phase of the therapeutic ultrasound wave of the ultrasound transmitting unit corresponding to the detection unit is.

Optionally, the total power of the excitation ultrasonic waves emitted by each of the ultrasonic transmitting units is between 1 W and 10 W;

The total power of the therapeutic ultrasound waves emitted by each of the ultrasound transmitting units is between 20W and 500W.

Optionally, the frequency of the excitation ultrasonic wave is between 500kHz and 10MHz;

The frequency of the therapeutic ultrasound is between 500kHz and 10MHz.

Optionally, the plurality of ultrasonic transmitting units are divided into a first group and a second group, the first group includes a plurality of ultrasonic transmitting units, and the second group includes a plurality of ultrasonic transmitting units;

The excitation ultrasonic waves emitted by the plurality of ultrasonic transmitting units of the first group have a first frequency;

The excitation ultrasonic waves emitted by the second group of multiple ultrasonic transmitting units have a second frequency, and the first frequency is not equal to the second frequency.

Optionally, the excitation ultrasound wave is a pulse ultrasound wave or a continuous ultrasound wave.

In the present invention, each ultrasonic transmitting unit generates a focused excitation ultrasonic wave at the position to be treated to stimulate the tissue vibration at the focus to emit a secondary sound wave, and the secondary sound wave received by each detection unit is generated at the focus (i.e., the position to be treated) and then propagated to the detection unit, and its propagation path is the propagation path of the therapeutic ultrasonic wave emitted by the ultrasonic transmitting unit corresponding to the detection unit; therefore, each detection unit can be controlled to emit a therapeutic ultrasonic wave with specific parameters (target parameters) according to the situation of the secondary sound wave, so as to ensure that the therapeutic ultrasonic wave emitted by each detection unit can accurately reach the required phase, amplitude and other parameters at the focus at the same time, so as to more accurately and effectively control the size, shape and energy of the focal area.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic block diagram of the composition of an ultrasonic treatment device according to an embodiment of the present invention;

FIG. 2 is a schematic block diagram of another ultrasonic treatment device according to an embodiment of the present invention.

FIG3 is a schematic diagram of a working process of an ultrasonic treatment device according to an embodiment of the present invention;

FIG. 4 is a schematic diagram showing the relationship between an ultrasonic transducer and a focus in another ultrasonic treatment device according to an embodiment of the present invention.

Detailed ways

In order to enable those skilled in the art to better understand the technical solution of the present invention, the present invention is further described in detail below in conjunction with the accompanying drawings and specific implementation methods.

It should be understood that the specific embodiments and drawings described herein are only used to explain the present invention rather than to limit the present invention.

It can be understood that, in the absence of conflict, the various embodiments of the present invention and the various features therein can be combined with each other.

It can be understood that, for the convenience of description, the drawings of the present invention only show the parts related to the embodiments of the present invention, while the parts unrelated to the embodiments of the present invention are not shown in the drawings.

In high-intensity focused ultrasound (HIFU) treatment, ultrasound waves emitted by multiple ultrasound transmitting units are focused on the tissue to be treated in the human body to treat the tissue to be treated (such as deforming the diseased tissue).

Precisely controlling the size, shape, and energy of the focal area is important for improving the treatment effect, and this requires that the ultrasound waves emitted by each ultrasound transmitting unit simultaneously reach the required phase, amplitude, and other parameters at the focal point. However, the change in ultrasound parameters is related to the acoustic medium it passes through, and the human body is a complex, non-uniform acoustic medium. Therefore, the acoustic medium conditions of ultrasound waves emitted by different ultrasound transmitting units in the human body are different and difficult to predict, so it is very difficult to ensure that the ultrasound waves emitted by each ultrasound transmitting unit simultaneously reach the required parameters at the focal point.

In some related technologies, the "Time Reversal" technology is used to adjust the parameters of ultrasound. For example, each ultrasound transmitting unit emits ultrasound and records the received echoes respectively. The echo reflects the condition of the acoustic medium it has passed through, so the parameters of the ultrasound emitted by the ultrasound transmitting unit can be adjusted accordingly according to the echo. However, the above "echo" is a reflected ultrasound wave, and many tissues in the human body may cause reflections, so the echo is not necessarily reflected from the focus. Therefore, the echo situation cannot accurately reflect the condition of the acoustic medium between the ultrasound transmitting unit and the focus. It is still difficult to achieve accurate control of the size, shape, and energy of the focal area based on the echo.

In a first aspect, an embodiment of the present invention provides an ultrasonic treatment device.

The ultrasonic treatment device of the embodiment of the present invention is used to perform high-intensity focused ultrasound (HIFU) treatment on patients, such as deforming diseased tissues through high-intensity focused ultrasound, for example, to treat benign and malignant tumors such as uterine fibroids.

1 , the ultrasonic treatment device according to the embodiment of the present invention includes a plurality of ultrasonic transmitting units, a plurality of detection units, and a control module;

A plurality of ultrasound transmitting units are used to emit ultrasound waves toward a focal point;

The detection units correspond to the ultrasonic transmitting units one by one, and each detection unit is arranged at its corresponding ultrasonic transmitting unit.

The ultrasonic treatment device of the embodiment of the present invention includes multiple ultrasonic transmitting units (array elements), each of which is arranged at a predetermined position and can emit ultrasonic waves in a predetermined direction. The ultrasonic waves emitted by each ultrasonic transmitting unit pass through the same point (focus), so the ultrasonic waves emitted by the ultrasonic treatment device as a whole are ultrasonic waves focused at the "focus".

For example, referring to Figure 4, the ultrasonic treatment device may include an ultrasonic transducer, which has an emitting surface for emitting ultrasonic waves. The emitting surface can be in various forms. To facilitate focusing, it can usually be a part of a sphere, such as a spherical crown surface, a spherical segment surface, two opposite spherical crown surfaces, etc.

The ultrasonic transmitting unit is an "array element" arranged at various positions on the transmitting surface of the ultrasonic transducer. Each array element can emit ultrasonic waves relatively independently (such as emitting to the center of a sphere). That is, the focus of each ultrasonic transmitting unit can be the center of the sphere, and the ultrasonic transducer can be a "phased array ultrasonic transducer" to achieve "phased array ultrasonic focusing".

Each ultrasonic transmitting unit is also provided with a corresponding detection unit. The corresponding ultrasonic transmitting unit and the detection unit are arranged at the same or close position, and the detection unit is used to detect the received sound waves (including ultrasonic waves). Therefore, the detection unit can actually detect the sound waves received at its corresponding ultrasonic transmitting unit.

The ultrasonic transmitting unit may be any device that can emit sound, such as a piezoelectric device.

The detection unit may be any device capable of sensing sound, such as a piezoelectric device.

Optionally, the ultrasonic transmitting unit and the corresponding detection unit are an integrated structure.

As one embodiment of the present invention, referring to FIG. 4 , the corresponding ultrasonic transmitting unit and detecting unit may be “a device (such as a piezoelectric device)”, which can both emit ultrasonic waves when driven and sense received sound waves.

It should be understood that it is also feasible if the corresponding ultrasonic transmitting unit and the detecting unit are independent devices.

It should be understood that it is also feasible that a plurality of array elements in the ultrasonic transducer that are close in position correspond to the same detection unit. In this case, the plurality of array elements are regarded as one ultrasonic transmitting unit.

It should be understood that, with reference to FIG. 2 , the ultrasonic treatment device of the embodiment of the present invention may further include other modules, such as a power supply module for providing a driving signal to each ultrasonic transmitting unit so that it emits ultrasonic waves, a driving module for driving each ultrasonic transmitting unit (ultrasonic transducer) to move to change the specific position of the focus, a supporting module (such as a treatment bed) for supporting the patient's body, a medium module for containing an acoustic medium (such as degassed water), a purification module (such as a degassing device) for providing an acoustic medium, etc., which will not be described in detail here.

Among them, the specific forms, quantities, positional relationships, etc. of the above modules are diverse and will not be described in detail here.

3, in the ultrasonic treatment device of the embodiment of the present invention, the control module is used to control the ultrasonic transmitting unit and the detection unit to perform the following work flow:

S101, each ultrasound transmitting unit emits an excitation ultrasound wave with the position to be treated as a focus, and each detection unit records the infrasonic wave parameters of the received secondary sound wave.

Among them, the exciting ultrasound can stimulate the tissue at the focus to vibrate and emit secondary sound waves.

S102: Determine target parameters of the therapeutic ultrasound waves emitted by each ultrasound transmitting unit according to predetermined focal zone parameters and infrasonic wave parameters.

Among them, therapeutic ultrasound can treat tissue at the focal point.

S103. Each ultrasound transmitting unit takes the position to be treated as a focus and emits a therapeutic ultrasound according to target parameters.

In the embodiment of the present invention, the control module can control other components of the ultrasonic treatment device to operate according to a specific workflow.

Firstly, a certain position in the human body that needs treatment (position to be treated) can be determined through B-ultrasound images, manual designation, etc., and each ultrasonic transmitting unit can be controlled to emit focused excitation ultrasonic waves with this position as the focus.

Among them, the energy of the exciting ultrasound is small and will not damage the tissue at the focus, so it has no therapeutic effect; but the exciting ultrasound can cause the tissue at the focus to vibrate, and the vibration of the tissue will emit new sound waves, namely secondary sound waves.

Each detection unit can receive the above secondary sound waves and analyze and obtain various parameters (infrasonic wave parameters) related to the secondary sound waves.

Obviously, the secondary sound waves received by each detection unit are emitted from the focus (tissue to be treated) and then propagated to its corresponding ultrasonic transmitting unit, while the ultrasonic waves emitted by the ultrasonic transmitting unit are propagated from the ultrasonic transmitting unit to the focus (tissue to be treated). Therefore, the propagation paths of the above two sound waves are the same (of course in opposite directions), and the sound medium conditions they experience are also the same (of course, they must target one tissue to be treated, and the patient cannot move during the process).

Among them, the ultrasonic waves emitted by each ultrasonic transmitting unit are theoretically converged at the focus, but in fact a very high energy area will be formed near the focus, namely the "focal zone", or in other words, the focal zone is a real focal area, and in order to achieve the desired therapeutic effect, the focal zone needs to meet certain characteristics (focal zone parameters).

Therefore, the control module can analyze and determine the acoustic medium conditions experienced by each ultrasonic emitting unit when the therapeutic ultrasonic wave propagates to the focus according to the above infrasound wave parameters, and then determine (or adjust) the ultrasonic wave. What parameters (target parameters) should be used for the therapeutic ultrasound emitted by the transmitting unit so that the focal area conditions can meet the required focal area parameters.

Therefore, each ultrasound transmitting unit can subsequently use the position to be treated as a focus and emit therapeutic ultrasound according to the target parameters determined above. The energy of the therapeutic ultrasound is relatively high, so it can treat the tissue at the position to be treated.

In the present invention, each ultrasonic transmitting unit generates a focused excitation ultrasonic wave at the position to be treated to stimulate the tissue vibration at the focus to emit a secondary sound wave, and the secondary sound wave received by each detection unit is generated at the focus (i.e., the position to be treated) and then propagated to the detection unit, and its propagation path is the propagation path of the therapeutic ultrasonic wave emitted by the ultrasonic transmitting unit corresponding to the detection unit; therefore, each detection unit can be controlled to emit a therapeutic ultrasonic wave with specific parameters (target parameters) according to the situation of the secondary sound wave, so as to ensure that the therapeutic ultrasonic wave emitted by each detection unit can accurately reach the required phase, amplitude and other parameters at the focus at the same time, so as to more accurately and effectively control the size, shape and energy of the focal area.

Optionally, the total power of the excitation ultrasonic waves emitted by each ultrasonic transmitting unit is between 1 W and 10 W;

The total power of the therapeutic ultrasound waves emitted by each ultrasound transmitting unit is between 20W and 500W.

As one embodiment of the present invention, the total power of the excitation ultrasound waves emitted by all ultrasound transmitting units may be 1 to 10 W, further 2 to 8 W, further 4 to 6 W; and when all ultrasound transmitting units emit therapeutic ultrasound waves, the total power used may be 20 to 500 W, further 50 to 400 W, further 100 to 350 W.

Optionally, the frequency of the exciting ultrasonic wave is between 500kHz and 10MHz;

The frequency of therapeutic ultrasound is between 500kHz and 10MHz.

Accordingly, the frequency of the excitation ultrasound may be 0.5 to 10 MHz, further 1 to 8 MHz, further 2 to 6 MHz; and the frequency of the therapeutic ultrasound may be 0.5 to 10 MHz, further 1 to 8 MHz, further 2 to 6 MHz.

Optionally, the focal area parameters include at least one of the shape, size, and energy of the focal area.

As a method of an embodiment of the present invention, by adjusting the target parameters, the shape, size, energy, etc. of the focal area can be specifically controlled, such as making the size of the focal area smaller, the energy higher, and forming a desired predetermined shape, etc.

Optionally, the excitation ultrasound wave is a pulsed ultrasound wave or a continuous ultrasound wave.

As one embodiment of the present invention, the excitation ultrasonic wave may be a pulse ultrasonic wave or a continuous ultrasonic wave.

As one embodiment of the present invention, the therapeutic ultrasound may be pulsed ultrasound or continuous ultrasound.

Optionally, the infrasound wave parameter includes at least one of a receiving time of the secondary sound wave and an amplitude of the secondary sound wave.

As one mode of an embodiment of the present invention, for the received infrasound wave, its specific detectable infrasound wave parameters include its receiving time, amplitude, etc.

Optionally, the target parameter includes at least one of the phase and amplitude of the therapeutic ultrasound.

As one method of an embodiment of the present invention, target parameters such as phase and amplitude of the therapeutic ultrasound wave may be adjusted according to the required focal zone parameters and the detected infrasonic wave parameters.

Optionally, the plurality of ultrasonic transmitting units are divided into a first group and a second group, the first group includes a plurality of ultrasonic transmitting units, and the second group includes a plurality of ultrasonic transmitting units;

The excitation ultrasonic waves emitted by the first group of multiple ultrasonic transmitting units have a first frequency;

The excitation ultrasonic waves emitted by the second group of multiple ultrasonic transmitting units have a second frequency, and the first frequency is not equal to the second frequency.

As one embodiment of the present invention, all ultrasound transmitting units can be divided into two groups (for example, the number of ultrasound transmitting units in the two groups can be the same or as close as possible, and distributed as evenly as possible), and when emitting excitation ultrasound waves, the ultrasound transmitting units in the same group can be controlled to emit excitation ultrasound waves of the same frequency, while the frequencies of the excitation ultrasound waves emitted by the two groups of ultrasound transmitting units are different, namely, the first frequency and the second frequency; in this way, an ultrasound wave of "difference frequency" will be formed at the focus, and the "difference frequency" ultrasound wave is used to generate a dynamic acoustic radiation force to drive the tissue at the focus to vibrate, so that the vibration frequency of the tissue at the focus is substantially equal to the frequency of the above "difference frequency".

It should be understood that it is also feasible to use an excitation ultrasound wave of a certain frequency to induce tissue vibration in other ways. For example, when the emitting surface of the ultrasonic transducer includes two opposite spherical surfaces, the excitation ultrasound wave emitted from one spherical surface can be reflected back by the other spherical surface, thereby forming a standing wave at the focus, and the standing wave can also induce vibration of the tissue at the focus.

Optionally, the focal region parameters include the shape and size of the focal region;

Infrasound wave parameters include the reception time of receiving the infrasound wave;

Target parameters include the phase of the therapeutic ultrasound waves;

Among them, the earlier the detected receiving time is, the later the phase of the therapeutic ultrasound wave of the ultrasound transmitting unit corresponding to the detection unit is.

Among them, the distance between each ultrasonic transmitting unit and the focus is usually equal. Therefore, if in a uniform sound medium, each detection unit should receive the secondary sound wave basically at the same time. If the time (receiving time) when each detection unit receives the secondary sound wave is different, it means that the difference in the receiving time is caused by the different delays caused by the sound media in different positions.

To this end, the phase of the therapeutic ultrasonic wave emitted by each ultrasonic transmitting unit can be "reversely" adjusted according to the order in which each detection unit (that is, the ultrasonic transmitting unit) receives the secondary sound wave. That is, the earlier the detection unit receives the secondary sound wave, the later its corresponding ultrasonic transmitting unit will emit the therapeutic ultrasonic wave (and the later the phase of the emitted therapeutic ultrasonic wave).

It should be understood that the phase of the ultrasonic transmitting unit in the embodiment of the present invention refers to the phase of the ultrasonic waves being emitted by each ultrasonic transmitting unit at any same moment.

The difference in the phase of the ultrasonic wave emitted by each ultrasonic emitting unit at the same time can be achieved in a variety of specific ways. For example, each ultrasonic emitting unit may start emitting ultrasonic waves with different initial phases at the same time; or each ultrasonic emitting unit may emit ultrasonic waves with the same initial phase but start emitting ultrasonic waves at different times.

It should be understood that in addition to controlling the size and shape of the focal zone by adjusting the phase of the therapeutic ultrasound, other focal zone parameters can also be controlled by controlling other target parameters. For example, the energy (including energy distribution) of the focal zone can be controlled by adjusting the amplitude of the therapeutic ultrasound emitted by each ultrasound transmitting unit.

It is to be understood that the above embodiments are merely exemplary embodiments used to illustrate the principles of the present invention, but the present invention is not limited thereto. For those of ordinary skill in the art, various modifications and improvements can be made without departing from the spirit and essence of the present invention, and these modifications and improvements are also considered to be within the scope of protection of the present invention.

Claims (10)

An ultrasonic treatment device, characterized in that it comprises a plurality of ultrasonic transmitting units, a plurality of detection units, and a control module; The plurality of ultrasound transmitting units are used to emit ultrasound waves toward a focus; The detection units correspond to the ultrasonic transmitting units one by one, and each detection unit is arranged at the corresponding ultrasonic transmitting unit; The control module is used to control the ultrasonic transmitting unit and the detection unit to perform the following work flow: Each of the ultrasonic emitting units emits an excitation ultrasonic wave with the position to be treated as the focus, and each of the detecting units records the infrasound wave parameters of the received secondary sound waves; the excitation ultrasonic wave can excite the tissue at the focus to vibrate and emit the secondary sound waves; Determining target parameters of the therapeutic ultrasound waves emitted by each of the ultrasound transmitting units according to the predetermined focal zone parameters and the infrasound wave parameters; the therapeutic ultrasound waves can treat tissues at the focal point; Each of the ultrasound transmitting units takes the position to be treated as a focus and emits the therapeutic ultrasound according to the target parameters. The ultrasonic treatment device according to claim 1, characterized in that The ultrasonic transmitting unit and the corresponding detecting unit are an integrated structure. The ultrasonic treatment device according to claim 1, characterized in that The focal area parameters include at least one of the shape, size, and energy of the focal area. The ultrasonic treatment device according to claim 1, characterized in that The infrasound wave parameter includes at least one of a receiving time when the secondary sound wave is received and an amplitude of the secondary sound wave. The ultrasonic treatment device according to claim 1, characterized in that The target parameter includes at least one of a phase and an amplitude of the therapeutic ultrasound wave. The ultrasonic treatment device according to claim 1, characterized in that The focal area parameters include the shape and size of the focal area; The infrasound wave parameters include a receiving time when the secondary sound wave is received; The target parameters include the phase of the therapeutic ultrasound waves; Among them, the earlier the detected receiving time is, the later the phase of the therapeutic ultrasound wave of the ultrasound transmitting unit corresponding to the detection unit is. The ultrasonic treatment device according to claim 1, characterized in that The total power of the excitation ultrasonic waves emitted by each of the ultrasonic transmitting units is between 1W and 10W; The total power of the therapeutic ultrasound waves emitted by each of the ultrasound transmitting units is between 20W and 500W. The ultrasonic treatment device according to claim 1, characterized in that The frequency of the excitation ultrasonic wave is between 500kHz and 10MHz; The frequency of the therapeutic ultrasound is between 500kHz and 10MHz. The ultrasonic treatment device according to claim 1, characterized in that The plurality of ultrasonic transmitting units are divided into a first group and a second group, the first group includes a plurality of ultrasonic transmitting units, and the second group includes a plurality of ultrasonic transmitting units; The excitation ultrasonic waves emitted by the plurality of ultrasonic transmitting units of the first group have a first frequency; The excitation ultrasonic waves emitted by the second group of multiple ultrasonic transmitting units have a second frequency, and the first frequency is not equal to the second frequency. The ultrasonic treatment device according to claim 1, characterized in that The excitation ultrasonic wave is a pulse ultrasonic wave or a continuous ultrasonic wave.