CN110465008B - Focused ultrasound treatment system - Google Patents

Abstract

The invention discloses a focused ultrasound treatment system, which comprises an ultrasound transmitting device, a signal acquisition device, an imaging device, a central processing device and a feedback control device. The ultrasonic transmitting equipment transmits focused ultrasound to a target area or a target point part, and the signal acquisition equipment and the imaging equipment are matched with the central processing equipment and the feedback control equipment to realize the positioning of the target point part and real-time adjustment of the relative position of a focused ultrasound focus and the target point part. The ultrasonic therapy device has the advantages that better tracking of therapeutic target points is realized, the ultrasonic therapy dosage is adjusted in real time, the accuracy of therapy positioning and the target point tracking capability are improved, the accuracy and the stability of dosage required by therapy are guaranteed, in addition, temperature change parameters can be determined in the therapy process, and the feedback control device adjusts working parameters of the ultrasonic transmitting device according to echoes and the temperature change parameters, so that the overhigh temperature of local tissues of a patient is effectively avoided, the therapy efficiency is improved, and the pain and the side effect of the patient are relieved.

Description

Focused ultrasound treatment system

Technical Field

The invention relates to the technical field of medical instruments, in particular to a focused ultrasound treatment system.

Background

In vitro Focused Ultrasound (EFU) utilizes the characteristics of good targeting, convergence and penetrability of Ultrasound, low-energy-density Ultrasound is Focused at a target site in vivo after passing through skin and pathway tissues in vitro, a focal region with extremely high energy density can be formed in a target region, and coagulation necrosis of tissues occurs in a short time through the heat, cavitation, mechanical effect and the like of Ultrasound, while the ultrasonic pathway and surrounding tissues are less or not damaged, so that the aims of noninvasive treatment, ablation or ablation of the target tissue are fulfilled, and the EFU is widely applied to the ablation treatment of tumors. Research shows that nerve tissue has a special lipid bilayer membrane structure, so that the nerve tissue is very sensitive to ultrasonic energy, and therefore, the function of the nerve tissue can be changed or irreversible necrosis can be caused by lower dose of the ultrasonic energy, so that EFU ablation is gradually expanded to be applied to the field of nerve regulation in recent years, for example, renal sympathetic nerve is removed to treat autonomic nerve function disorder diseases such as hypertension, heart failure and the like. It has also been discovered in recent years that lower focused ultrasound energy can be used for functional modulation of tissues, organs or whole bodies. As non-invasive and non-ionizing energy, patients have a good treatment mode, and EFU has important prospects in disease treatment and body function regulation.

For example, in the current EFU renal sympathetic denervation treatment process, the positioning is generally performed by means of imaging of an imaging device, but the imaging only displays the renal artery and cannot display the renal sympathetic nerves, since the renal sympathetic nerves are distributed around the renal artery, an operator randomly delivers energy around the renal artery according to the renal artery image and by combining self experience, but since the distribution of the renal sympathetic nerves varies greatly among individuals, the distribution of the renal sympathetic nerves of different individuals cannot be accurately judged only by the experience of the operator, so that the delivered energy also damages tissue components which do not need to be treated, such as microvessels and lymph around the renal artery, and therefore, the positioning mode has certain blindness.

On the other hand, the renal artery often meanders in the perivascular tissue under the actual condition, and the single-plane two-dimensional ultrasound commonly used in the conventional EFU ablation can only display partial segments of the renal artery at a certain moment, but cannot provide the overall anatomical information of the renal artery; meanwhile, the breathing motion of the patient also causes the spatial position of the blood vessel to change constantly, so that an operator needs to move the probe constantly and change the section to confirm the position relation between the focus and the renal blood vessel, thereby greatly increasing the treatment time and influencing the satisfaction degree of the operator. Although the spatial walking of the blood vessel can be constructed by image enhancement and three-dimensional reconstruction by using CT or MRI, the defects of long imaging time, poor real-time performance, large radiation dose and high price exist.

In addition, the current EFU treatment process lacks a corresponding method for determining the effect of target ablation and the timing of terminating treatment. Increasing the energy dose or extending the time of target ablation to ensure therapeutic effect can result in excessive local tissue temperature, which greatly increases patient pain. Therefore, in order to effectively ablate the target without causing excessive damage, the detection of the focal point temperature will directly affect the therapeutic effect. The traditional invasive temperature measurement brings pain to patients, such as: pain, infection, damage to adjacent organs, and thus its use is greatly limited.

In summary, the conventional focused ultrasound therapy system has the following problems: the target point is positioned by depending on the subjectivity of an operator, and the target point can move along with the respiration of a patient, so that the treatment efficiency is low, in addition, the inaccurate control of the working parameters of the focused ultrasound leads to the overhigh temperature of local tissues, so that the pain of the patient is increased, and the problem needs to be solved by the technical personnel in the field.

Disclosure of Invention

The invention aims to provide a focused ultrasound treatment system, which is used for solving the problems that the traditional focused ultrasound treatment system cannot accurately position a target point, so that the treatment efficiency is low, and the pain and the injury of a patient are increased due to inaccurate control of working parameters of focused ultrasound.

In order to solve the above technical problem, the present invention provides a focused ultrasound treatment system, comprising:

the ultrasonic transmitting equipment is used for transmitting focused ultrasonic to a target area when receiving a positioning instruction and transmitting the focused ultrasonic to a target point part when receiving an ablation instruction, wherein the target area comprises the target point part; the ultrasonic focusing device is also used for adjusting the working parameters of the ultrasonic transmitting device according to an adjusting instruction sent by the feedback control device, and adjusting the relative position of the focused ultrasonic focus and the target area, or adjusting the relative position of the focused ultrasonic focus and the target point part;

the signal acquisition equipment is used for acquiring tissue echoes of the target area and the target point part in the positioning process, converting the echoes into corresponding echo signals and sending the echo signals to the central processing equipment;

the imaging device is used for constructing image information of the target area in the positioning process and sending the image information to the central processing device; the texture information acquisition module is also used for acquiring first texture information of the target site at the beginning of treatment or ablation, acquiring second or Nth texture information of the target site in the treatment or ablation process, calculating a texture information variable and sending the texture information variable to the central processing equipment, wherein N is a positive integer greater than or equal to 3; the device is also used for confirming the depth information from the body surface to the target point position by measuring the axis of the focused sound beam, or detecting the body surface boundary by a two-dimensional or three-dimensional image, determining the volume of the focused sound cone, generating a target point energy calculation result and sending the target point energy calculation result to the feedback control equipment;

the central processing device is used for sending the positioning instruction to the ultrasonic transmitting device when the positioning is started, and constructing the distribution information of the target point part in the target area according to the echo signal transmitted by the signal acquisition device in the positioning process; the ultrasonic ablation device is also used for sending the ablation instruction to the ultrasonic emission device when treatment or ablation starts, and constructing a temperature change parameter of the target point part according to the texture information variable in the ablation process; the acoustic resistance information on the focused acoustic beam acoustic channel is constructed according to the echo signal;

the feedback control device is configured to generate the adjustment instruction according to the distribution information of the target point portion, the temperature change parameter, the volume of the focused acoustic cone, the target point energy calculation result, and the acoustic resistance information, and send the adjustment instruction to the ultrasonic transmitting device.

Preferably, the ultrasound transmission apparatus includes: an ultrasonic transmitting module and a focused ultrasonic transducer or a transducer group;

the ultrasonic transmitting module is used for generating a working instruction and sending the working instruction to the focused ultrasonic transducer or the transducer group, wherein the working instruction comprises a positioning instruction and an ablation instruction;

the focused ultrasonic transducer or the transducer group comprises one group, two groups or more than two groups of focused ultrasonic transducer array elements which are respectively a first array element group, a second array element group or an Nth array element group, the first array element group is used for transmitting difference frequency focused ultrasound or sweep frequency focused ultrasound to the target area when receiving the positioning instruction, the second array element group or the Nth array element group is used for transmitting same frequency focused ultrasound, difference frequency focused ultrasound or sweep frequency focused ultrasound to the target point part when receiving the ablation instruction, wherein N is a positive integer greater than or equal to 3.

Preferably, each of the focused ultrasound transducer array elements is controlled by a separate signal generator and power amplifier.

Preferably, the signal acquisition device comprises a signal receiving module and a signal conversion module;

the signal receiving module is positioned around the focused ultrasound focus and used for acquiring tissue echoes generated by the target region under the stimulation of the focused ultrasound; the device is also used for acquiring a first reflection echo of the target point part at the beginning of ablation and acquiring a second or Nth reflection echo of the target point part in the ablation process; the device is also used for acquiring attenuation echoes of the target area and/or the target point part, wherein N is a positive integer greater than or equal to 3;

the signal conversion module is connected with the signal receiving module and is used for converting the tissue echo into a corresponding echo signal and respectively converting the first reflection echo, the second reflection echo or the Nth reflection echo into a first reflection signal and a second reflection signal or an Nth reflection signal; and also for converting the attenuated echo into an attenuated signal;

the signal conversion module is connected with the central processing equipment and sends the echo signal, the first reflection signal, the second or Nth reflection signal and the attenuation signal to the central processing equipment.

Preferably, the signal acquisition device is further configured to acquire and calculate an echo sound intensity or a backscattering integral of the echo radio frequency signal, determine sound attenuation of the focused ultrasound beam reaching the target point according to the echo sound intensity or the backscattering integral, and send the sound attenuation to the feedback control device, so as to adjust working parameters of the ultrasound transmitting device.

Preferably, the imaging device comprises an imaging probe group and an imaging host;

wherein the imaging probe group comprises a plurality of imaging probes, and the arrangement mode of the imaging probes is as follows any one or more: i-shaped, cross-shaped, L-shaped, T-shaped and mouth-shaped; the imaging probe is used for sending imaging sound waves to the target area according to the imaging instruction sent by the imaging host and receiving imaging echoes; the imaging host is also used for acquiring the first texture information and the second or Nth texture information according to a texture information acquisition instruction sent by the imaging host;

the imaging host is used for constructing image information of the target area according to the imaging echo and calculating to obtain the texture information variable according to the first texture information and the second or Nth texture information.

Preferably, the imaging device is a multi-plane ultrasonic imaging device, and is configured to acquire real-time doppler blood flow information of a preset blood vessel in the target region, and send the real-time doppler blood flow information to a central processing device; the central processing device is used for comparing the real-time Doppler blood flow information with preset reference Doppler blood flow information to obtain a comparison result; and the feedback control equipment is used for controlling the stepping motor to move when the comparison results of the central processing equipment are different until the comparison results of the central processing equipment are the same.

Preferably, the image information of the target area is in the form of any one or more of the following: grayscale images, color doppler images, virtual tissue images.

Preferably, the imaging device is further configured to detect a hyperechoic interface according to a two-dimensional or three-dimensional image, and warn and turn off the focused ultrasound transducer in the corresponding region when the hyperechoic interface is detected, so as to prevent the ineffective energy release of the ultrasound transducer from causing tissue damage.

Preferably, the central processing device comprises a target location module and a temperature monitoring module;

the target point positioning module is specifically used for establishing the distribution information of the target point part in the target area by comparing the echo signal with a preset echo signal parameter;

the temperature monitoring module is specifically used for inputting the texture information variable into a preset temperature calculation model and constructing a temperature change parameter of the target point part in the ablation process.

Preferably, the distribution information of the target site includes any one or more of target distribution range, target distribution density and target histopathological state.

Preferably, the feedback control device is specifically configured to generate the adjustment instruction by comparing the temperature variation parameter with a preset temperature variation parameter.

Preferably, the signal acquisition device is further configured to acquire an attenuated echo signal formed by the target region under the action of the focused ultrasound before ablation, convert the attenuated echo signal into an attenuated signal, and send the attenuated signal to the central processing device;

the imaging device is further used for determining boundary information formed by the focused acoustic beam in the target area before ablation, calculating to obtain a focused acoustic cone volume, and sending the focused acoustic cone volume to the central processing device;

the central processing device is further configured to calculate a focused ultrasound dose from the attenuation signal and the focused acoustic cone volume prior to ablation;

the ultrasonic transmitting equipment is used for determining the initial focused ultrasonic dose at the beginning of ablation according to the focused ultrasonic dose.

The invention provides a focused ultrasound treatment system, which comprises an ultrasound transmitting device, a signal acquiring device, an imaging device, a central processing device and a feedback control device, wherein the ultrasound transmitting device is used for transmitting focused ultrasound to a target area or a target point part, the imaging device is used for constructing image information of the target area and acquiring and calculating texture information variables, the signal acquiring device is used for acquiring echo signals and echo attenuation information and acquiring and calculating reflection signal variables, the central processing device is used for determining the distribution condition of the target point part according to the image information and the echo signals of the target area, constructing temperature change parameters according to the texture information variables and the reflection signal variables and determining acoustic resistance information according to the echo attenuation information, and the feedback control device is used for determining the temperature change parameters, the temperature change parameters and the like according to the distribution condition, the temperature change parameters, And generating an adjusting instruction by the acoustic resistance information, sending the adjusting instruction to the ultrasonic transmitting equipment, and then adjusting the working parameters and the relative position of the focused ultrasonic focus and the target point part or adjusting the relative position of the focused ultrasonic focus and the target area by the ultrasonic transmitting equipment according to the adjusting instruction. Therefore, the system can adjust the relative position of the focused ultrasound focus and the target point in real time in the treatment process by utilizing the imaging equipment and the signal acquisition equipment, reduces the subjectivity of positioning the target point, improves the treatment efficiency, can determine the temperature change parameter according to the texture information variable and the reflection signal variable, and adjust the working parameter of the ultrasound transmitting equipment according to the temperature change parameter, thereby effectively avoiding causing overhigh temperature of the local tissues of the patient and relieving the pain of the patient.

Drawings

In order to more clearly illustrate the embodiments or technical solutions of the present invention, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained based on these drawings without creative efforts.

FIG. 1 is a schematic structural diagram of an embodiment of a focused ultrasound therapy system provided by the present invention;

FIG. 2 is a schematic structural diagram of an ultrasound emitting device in an embodiment of a focused ultrasound therapy system provided by the present invention;

FIG. 3 is a schematic structural diagram of a signal acquisition device in an embodiment of a focused ultrasound therapy system provided by the present invention;

FIG. 4 is a schematic diagram of the operation of a signal acquisition device in an embodiment of a focused ultrasound therapy system provided by the present disclosure;

FIG. 5 is a schematic structural diagram of an imaging device in an embodiment of a focused ultrasound therapy system provided by the present invention;

FIG. 6 is a first schematic diagram illustrating the operation of an imaging device in an embodiment of a focused ultrasound therapy system provided by the present invention;

FIG. 7 is a diagram of a second embodiment of a focused ultrasound system according to the present invention;

FIG. 8 is a schematic diagram of an arrangement of imaging probes in an "I" shaped configuration in an imaging probe set of an imaging apparatus for use in a focused ultrasound therapy system in accordance with the present invention;

FIG. 9 is an intersection view of imaging sections of the probe of FIG. 8 according to the present invention;

FIG. 10 is a schematic diagram of a central processing unit of an embodiment of a focused ultrasound treatment system provided by the present invention;

FIG. 11 is a graph showing the distribution of target sites in a target area constructed by a central processing unit of an embodiment of a focused ultrasound treatment system according to the present invention;

fig. 12 is a schematic diagram of a target point temperature variation isotherm constructed by the central processing device of the focused ultrasound therapy system according to the embodiment of the invention.

Detailed Description

The core of the invention is to provide a focused ultrasound treatment system, which reduces the subjectivity of positioning a target point, improves the treatment efficiency, effectively avoids overhigh temperature of local tissues of a patient and relieves the pain of the patient.

In order that those skilled in the art will better understand the disclosure, the invention will be described in further detail with reference to the accompanying drawings and specific embodiments. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

An embodiment of a focused ultrasound therapy system provided by the present invention is described below, with reference to fig. 1, and the embodiment includes:

theultrasonic transmitting equipment 101 is used for transmitting focused ultrasonic to a target area when receiving a positioning instruction and transmitting the focused ultrasonic to a target point part when receiving an ablation instruction; and is further configured to adjust a working parameter of theultrasound emitting device 101 according to an adjustment instruction sent by thefeedback control device 105, and adjust a relative position of a focused ultrasound focus and the target point portion, or adjust a relative position of the focused ultrasound focus and the target area.

Thesignal acquisition device 102 is configured to acquire tissue echoes generated by the target region under the focused ultrasound stimulation in a positioning process, convert the tissue echoes into corresponding echo signals, and send the echo signals to thecentral processing device 104; and is further configured to acquire a first reflected echo of the target site at the beginning of ablation, acquire a second reflected echo of the target site during the ablation, convert the first reflected echo and the second reflected echo into a corresponding first reflected signal and a corresponding second reflected signal, calculate a reflected signal variable, and send the reflected signal variable to thecentral processing device 104. The device is also used for acquiring echo attenuation information of the target area and/or the target point part and sending the echo attenuation information to the central processing equipment.

Theimaging device 103 is used for constructing image information of the target area in the positioning process and sending the image information to the central processing device; and is further configured to acquire first texture information of the target site at the beginning of ablation, acquire second texture information of the target site during ablation, calculate a texture information variable, and send the texture information variable to thecentral processing device 104.

Thecentral processing device 104 is configured to send the positioning instruction to theultrasound transmitting device 101 when positioning starts, and construct target point distribution information of the target point portion in the target area according to the echo signal of the target area transmitted by thesignal acquiring device 102 in the positioning process; and theultrasonic transmitting device 101 is further configured to send the ablation instruction to theultrasonic transmitting device 101 when ablation starts, and construct a temperature change parameter of the target site in the ablation process according to the reflection signal variable and the texture information variable in the ablation process. And the acoustic resistance information on the focused acoustic beam acoustic channel is constructed according to the echo attenuation information.

Thefeedback control device 105 is configured to generate the adjustment instruction according to the target point distribution information, the temperature change parameter, and the acoustic resistance information, and send the adjustment instruction to theultrasound transmitting device 101.

As shown in fig. 2, the present embodiment provides a schematic structural diagram of anultrasound transmitting device 101 in a focused ultrasound therapy system, and theultrasound transmitting device 101 is described in detail below:

theultrasound transmitting apparatus 101 mainly includes anultrasound transmitting module 201 and afocused ultrasound transducer 202, wherein theultrasound transmitting module 201 mainly includes anultrasound driver 2011, asignal generator 2012 and apower amplifier 2013. The focusedultrasound transducer group 202 is composed of a plurality of focused ultrasound transducer array elements capable of working independently, and as a preferred mode, each focused ultrasound transducer array element may have functions of transmitting and receiving ultrasound waves at the same time, and may specifically select a special material capable of realizing transmission and reception at the same time, such as a piezoelectric film or a composite material. When thefocused ultrasound transducer 202 can transmit and receive ultrasound waves, it can replace a receiving module in thesignal acquisition device 102, thereby saving the manufacturing cost of the device. In this embodiment, the two groups of focused ultrasound transducer array elements are divided into a first array element group and a second array element group, where the first array element group is used to transmit difference frequency focused ultrasound or sweep frequency focused ultrasound to the target area when receiving the target point positioning instruction, and the second array element group is used to transmit same frequency focused ultrasound, difference frequency focused ultrasound or sweep frequency focused ultrasound to the target point part when receiving the target point ablation instruction.

When theultrasound emitting device 101 receives a positioning instruction or an ablation instruction, theultrasound driver 2011 outputs a driving signal, which is transmitted to thesignal generator 2012 and thepower amplifier 2013 to drive the focusedultrasound transducer group 202 to emit focused ultrasound to a preset target region or target point. Specifically, theultrasound driver 2011 is configured to send the driving signal to thesignal generator 2012 and thepower amplifier 2013 to generate a working instruction, and send the working instruction to the focusedultrasound transducer group 202, where the working instruction includes, but is not limited to, a target location instruction and a target ablation instruction. The focused ultrasonic transducer array element is used for transmitting difference frequency focused ultrasound or sweep frequency focused ultrasound to the target area when receiving the target point positioning instruction, and transmitting same frequency focused ultrasound, difference frequency focused ultrasound or sweep frequency focused ultrasound to the target point part when receiving the target point ablation instruction.

Preferably, each focused ultrasound transducer array element in the focusedultrasound transducer group 202 is controlled by adifferent signal generator 2012 and apower amplifier 2013 to form an independent focused ultrasound transmitting path, and the different paths transmit focused sound beams with different parameters, such as frequency, sound intensity or duty ratio.

Preferably, the arrangement of the focused ultrasound transducer array elements in thefocused ultrasound transducer 202 may be set according to practical situations, such as arrangement in a spacing manner, in which case the receivingmodule 301 in thesignal acquisition device 102 or the imaging probe of theimaging device 103 may be set in the spacing. In addition, the true elements of the focusing transducer may be arranged in a linear array, a two-dimensional array or a three-dimensional array, or may be arranged in a rectangular array, a concentric circular array, a spherical array, or the like, which is not particularly limited in this embodiment.

As shown in fig. 3, this embodiment provides a schematic structural diagram of asignal acquisition device 102 in a focused ultrasound therapy system, where thesignal acquisition device 102 mainly includes asignal receiving module 301 and asignal conversion module 302, and as shown in fig. 4, thesignal conversion module 302 is connected to thesignal receiving module 301, and is configured to convert the tissue echo into a corresponding echo signal, and further configured to convert the first reflected echo, the second reflected echo, or the nth reflected echo into the first reflected signal, the second reflected signal, or the nth reflected signal, respectively; and for converting the attenuated echo into an attenuated signal. The following begins with a detailed description of the signal acquisition device 102:

specifically, thesignal receiving module 301 is made of piezoelectric crystal, piezoelectric ceramic, polymer, electrostatic transducer or other acoustic-electric conversion materials, and may also be composed of a high-sensitivity hydrophone and related devices. With regard to the position of thesignal receiving module 301, thesignal receiving module 301 may be specifically disposed around the focused ultrasound focus of theultrasound transmitting device 101. The function of the ultrasonic diagnostic device is mainly to receive a first reflected echo and a second reflected echo generated by a target region after focused ultrasonic stimulation, and also to receive a tissue echo generated by a target site after focused ultrasonic stimulation, and then to send the first reflected echo, the second reflected echo and the tissue echo to thesignal conversion module 302.

Thesignal conversion module 302 is a conversion path formed by a preamplifier, a variable aperture circuit, a TGC amplifier, a gain control, a dynamic signal filter, a logarithmic amplifier, a wave detector, and the like, and converts the first reflected echo and the second reflected echo sent from thesignal receiving module 301 into a corresponding first reflected signal and a corresponding second reflected signal respectively, and calculates to obtain a reflected signal traversal, and is further configured to convert the tissue echo into an echo signal, and finally, thesignal acquisition device 102 sends the reflected signal traversal and the echo signal to thecentral processing device 104.

Wherein the transmitted signal variables include, but are not limited to: time shift of the echo signal, frequency shift of the echo signal, acoustic attenuation of the echo signal, power spectrum change of the echo signal, backscatter energy change of the echo signal, or other signal variable parameters selected according to actual needs.

As shown in fig. 5, the present embodiment provides a schematic structural diagram of animaging device 103 in a focused ultrasound therapy system, and theimaging device 103 mainly includes an imaging probe set 401 and animaging host 402. The following begins a detailed description of the imaging device 103:

specifically, theimaging probe group 401 is composed of a plurality of ultrasonic imaging probes capable of working independently, and transmits imaging waves to the target region according to an imaging instruction sent by theimaging host 402, then receives imaging echoes reflected by the imaging waves in the target region, and transmits the imaging echoes to theimaging host 402. Theimaging host 402 processes the imaging echo to obtain image information of the target region, and finally sends the image information to thecentral processing device 104. The image format of the image information constructed by theimaging host 402 may be set according to an actual situation, and specifically may include image formats such as a grayscale image, a color doppler image, a tissue doppler image, and a virtual tissue image.

Preferably, theimaging device 103 can also acquire first texture information of the target site at the beginning of ablation and second texture information during ablation, calculate a texture information variable, and send the texture information variable to thecentral processing device 104. Wherein the ultrasound texture variables include, but are not limited to: average gray level variation, cross entropy variation, mixed entropy variation, power spectral density variation, real-valued Gabor transform coefficients, or other texture variable parameters selected according to actual needs.

In addition, as shown in fig. 6, theimaging device 103 is further configured to determine depth information from the body surface to the target point by measuring an axis of the focused acoustic beam, or, as shown in fig. 7, theimaging device 103 detects a boundary of the body surface through a two-dimensional or three-dimensional image, determines a volume of the focused acoustic cone, generates a target point energy calculation result, and sends the target point energy calculation result to thefeedback control device 105.

Preferably, in this embodiment, the kind of theimaging device 103 may also be selected according to actual situations, and specifically may be one or a combination of multiple kinds of an ultrasound imaging device, a CT device, an MRI device, an OCT device, a photoacoustic device, and an infrared imaging device.

In addition, the arrangement and combination of the imaging probes in theimaging probe group 401 in theimaging device 103 should ensure that at least two imaging sections in all the imaging sections of the probes are in an intersecting relationship, for example, the imaging probes are in an "L" shape, an "i" shape, a "cross" shape, a "T" shape, an "x" shape, and the like. Referring to fig. 8 and fig. 9, respectively, fig. 8 is a schematic diagram illustrating an arrangement of imaging probes in an imaging probe set of an imaging device in the focused ultrasound therapy system according to this embodiment in an "i" shaped structure, fig. 9 is a schematic diagram illustrating an intersection of imaging sections of the probes in fig. 8, and for schematic diagrams of other arrangement structures, this embodiment is not shown one by one here.

Regarding the position of the imaging probe set 401, it is preferable that the imaging probe set 401 is disposed on a stepping motor, and the imaging probe set 401 is driven by the stepping motor to rotate freely in the space.

Referring to fig. 10, the present embodiment provides a schematic structural diagram of acentral processing device 104 in a focused ultrasound therapy system, as shown in fig. 10, thecentral processing device 104 mainly includes a targetpoint locating module 701 and atemperature monitoring module 702, and the following detailed description is made for the central processing device 104:

on one hand, in the ablation process, the distribution condition of the target point part in the target area needs to be determined, and the position of the target point part needing to be treated is accurate, so that the aim of improving the treatment efficiency is fulfilled. Therefore, positioning is required during the ablation process.

The main realization process of target location is as follows: theimaging device 103 is used for constructing image information of a target area, theultrasonic transmitting device 101 is used for transmitting focused ultrasonic waves to the target area, thesignal collecting device 102 is used for collecting tissue echoes reflected from the target area, and the tissue echoes are processed to obtain echo signals. Thetarget positioning module 701 plays a role in constructing target distribution information of target parts in a target area by combining image information and echo signals of the target area.

Specifically, inherent echo signal parameters of multiple tissues are preset in thetarget positioning module 701, when an actual ablation target changes as needed, the inherent echo signal parameters of the corresponding tissues can be selected as needed to be compared and analyzed with echo signals acquired by thesignal acquisition device 102 to obtain an analysis comparison result, and then the analysis comparison result is combined with image information of a target area constructed by theimaging device 103 to construct spatial distribution information of a target part in the target area.

Specifically, the image information of the target area may be single-plane, multi-plane, or 3D image information, and the spatial distribution information includes, but is not limited to: target distribution range, target distribution density, target histopathological state, and is expressed in the form of space gray-scale image, curve diagram, pseudo-color image or other forms. Fig. 11 is a graph of distribution of target points in a target region constructed by thecentral processing unit 104 of a focused ultrasound therapy system according to an embodiment of the present invention, and the rest of the distribution forms and possible distribution situations are not shown.

In addition, thetarget positioning module 701 may further process the change of the ultrasound feature of the highlighted therapeutic target by using a frame-by-frame comparison monitoring technique, an image subtraction technique, and the like, so as to detect the change of the ultrasound feature of the therapeutic target and whether the therapeutic target is achieved. Even the Doppler blood flow quantification technology can be used for monitoring the blood flow state of the main blood vessel of the target area and the local blood flow change of the target area, and monitoring whether the treatment target is achieved.

On the other hand, in the ablation process, the temperatures of the target point part and the target area need to be monitored, so that the pain of the patient caused by overhigh temperature is avoided, and the purpose of improving the use experience of the patient is realized. Therefore, temperature monitoring is required during ablation.

Thetemperature monitoring module 702 mainly functions as: according to the echo signal variable of the target point part transmitted by thesignal acquisition device 102 and the texture information variable transmitted by theimaging device 103, the real-time temperature variable information of the target point part is constructed based on the temperature measurement results of the preset echo signal variable-temperature variable model and the preset texture information variable-temperature variable model, and can be specifically expressed in the forms of a histogram, a curve graph and a isotherm diagram. The temperature measurement result based on the echo signal variable-temperature variable model is mainly used for temperature measurement of the core region of the target point part, and the temperature measurement result based on the texture information variable-temperature variable model is mainly used for temperature measurement of the peripheral region of the target point part.

In addition, according to the comparison result of the difference between the temperature measurement results and the preset difference, the early warning information can be automatically sent out to prompt an operator to stop the treatment process, or the early warning information can be sent to thecentral processing device 104, so that thecentral processing device 104 can actively stop the treatment process.

Referring to fig. 12, a schematic diagram of a target point temperature variation isotherm constructed by thecentral processing device 104 of the focused ultrasound therapy system according to the present embodiment is shown, and other temperature variation manifestations are not shown.

The main function of thefeedback control device 105 is to adjust the relative position of the focused ultrasound focus point and the target point, and to adjust the operating parameters of theultrasound emitting device 101.

During the treatment process, the spatial position of the blood vessel changes continuously due to some actions of the patient, such as respiratory motion, etc., and the operator needs to continuously move the probe of theimaging device 103 to replace the imaging section to find the correct target region, thereby increasing the treatment time. Specifically, thefeedback control device 105 obtains the distribution information of the target point in the target region from thecentral processing device 104, and then controls the ultrasonic emittingdevice 101 to perform focus movement until the focus is aligned with the target point.

Preferably, theimaging device 103 is a multi-plane ultrasound imaging device, and is configured to acquire real-time doppler blood flow information of a preset blood vessel in the target region, and send the real-time doppler blood flow information to thecentral processing device 104; thecentral processing 104 is further configured to compare the real-time doppler blood flow information with preset reference doppler blood flow information to obtain a comparison result; the correspondingfeedback control device 105 is used for controlling the stepping motor to move when the comparison result of the central processing device is different until the judgment result of the central processing device is the same.

Thefeedback control device 105 is further configured to obtain actual temperature variable information in real time, and send an instruction corresponding to the obtained actual temperature variable information to theultrasound transmitting device 101, where the instruction includes: an ablation instruction and an ablation stopping instruction, that is, when an instruction corresponding to the actual temperature variable information acquired by the feedback control device 801 is an ablation instruction or an ablation stopping instruction, the ablation instruction or the ablation stopping instruction is sent to theultrasound emitting device 101. By the method, an operator can timely know the ablation condition of the target site, and the condition that the pain of a patient is increased due to poor treatment effect caused by insufficient ablation time or overhigh temperature caused by overlong ablation time is avoided.

After removing the real-time location and temperature monitoring of the target site, the embodiment may also preferably adjust the focused ultrasound dose, which is generally related to the body type, obesity degree, etc. of the person, and the adjustment is generally performed before the ablation process. The specific adjustment process is as follows:

theimaging device 103 acquires shape information of the common-frequency focused ultrasound sound cone after theultrasound transmitting device 101 transmits the common-frequency focused ultrasound to a target point position in a preset target area. Meanwhile, thesignal acquisition device 102 may also acquire an attenuated echo signal of the target region under the focused ultrasound, and convert the attenuated echo signal into an attenuated signal. Thecentral processing device 104 can calculate the sound intensity at the focus according to the shape information and the attenuation signal, then obtain the corresponding treatment dose, generate a corresponding dose adjustment instruction, send the dose adjustment instruction to theultrasound emitting device 101, and finally theultrasound emitting device 101 determines the initial focused ultrasound dose at the beginning of ablation according to the dose adjustment instruction.

To sum up, the embodiment of the present invention discloses a focused ultrasound therapy system, which includes anultrasound transmitting device 101, asignal collecting device 102, animaging device 103, acentral processing device 104, and afeedback control device 105, wherein theultrasound transmitting device 101 transmits focused ultrasound to a target region or a target point, thesignal collecting device 102 and theimaging device 103 cooperate with thecentral processing device 104 to achieve the positioning of the target point, and adjust the relative position between the focused ultrasound focus and the target point or the relative position between the focused ultrasound focus and the target region in real time, so as to reduce the subjectivity of positioning the target point and improve the therapy efficiency, in addition, thecentral processing device 104 can also determine a temperature variation parameter by using the reflected signal variable and the texture information variable acquired by thesignal collecting device 102 and theimaging device 103 during the therapy process, and the feedback control device adjusts the working parameters of the ultrasound transmitting device according to the temperature variation parameter, thereby effectively avoiding causing the over-high temperature of the local tissues of the patient and relieving the pain of the patient.

Parts of the technical solutions provided in the embodiments of the present invention that are consistent with the implementation principles of the corresponding technical solutions in the prior art are not described in detail, so as to avoid redundant description. The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

It is further noted that, in the present specification, relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other identical elements in a process, method, article, or apparatus that comprises the element.

Claims (13)

1. A focused ultrasound therapy system, comprising:

the ultrasonic transmitting equipment is used for transmitting focused ultrasonic to a target area when receiving a positioning instruction and transmitting the focused ultrasonic to a target point part when receiving an ablation instruction, wherein the target area comprises the target point part; the ultrasonic focusing device is also used for adjusting the working parameters of the ultrasonic transmitting device according to an adjusting instruction sent by the feedback control device, and adjusting the relative position of the focused ultrasonic focus and the target area, or adjusting the relative position of the focused ultrasonic focus and the target point part;

the signal acquisition equipment is used for acquiring tissue echoes of the target area and the target point part in the positioning process, converting the echoes into corresponding echo signals and sending the echo signals to the central processing equipment;

the imaging device is used for constructing image information of the target area in the positioning process and sending the image information to the central processing device; the texture information acquisition module is also used for acquiring first texture information of the target site at the beginning of treatment or ablation, acquiring second or Nth texture information of the target site in the treatment or ablation process, calculating a texture information variable and sending the texture information variable to the central processing equipment, wherein N is a positive integer greater than or equal to 3; the device is also used for confirming the depth information from the body surface to the target point position by measuring the axis of the focused sound beam, or detecting the body surface boundary by a two-dimensional or three-dimensional image, determining the volume of the focused sound cone, generating a target point energy calculation result and sending the target point energy calculation result to the feedback control equipment;

the central processing device is used for sending the positioning instruction to the ultrasonic transmitting device when the positioning is started, and constructing the distribution information of the target point part in the target area according to the echo signal transmitted by the signal acquisition device in the positioning process; the ultrasonic ablation device is also used for sending the ablation instruction to the ultrasonic emission device when treatment or ablation starts, and constructing a temperature change parameter of the target point part according to the texture information variable in the ablation process; the acoustic resistance information on the focused acoustic beam acoustic channel is constructed according to the echo signal;

the feedback control device is configured to generate the adjustment instruction according to the distribution information of the target point portion, the temperature change parameter, the volume of the focused acoustic cone, the target point energy calculation result, and the acoustic resistance information, and send the adjustment instruction to the ultrasonic transmitting device.

2. The system of claim 1, wherein the ultrasound transmission device comprises: an ultrasonic transmitting module and a focused ultrasonic transducer or a transducer group;

the ultrasonic transmitting module is used for generating a working instruction and sending the working instruction to the focused ultrasonic transducer or the transducer group, wherein the working instruction comprises a positioning instruction and an ablation instruction;

the focused ultrasonic transducer or the transducer group comprises one group, two groups or more than two groups of focused ultrasonic transducer array elements which are respectively a first array element group, a second array element group or an Nth array element group, the first array element group is used for transmitting difference frequency focused ultrasound or sweep frequency focused ultrasound to the target area when receiving the positioning instruction, the second array element group or the Nth array element group is used for transmitting same frequency focused ultrasound, difference frequency focused ultrasound or sweep frequency focused ultrasound to the target point part when receiving the ablation instruction, wherein N is a positive integer greater than or equal to 3.

3. The system of claim 2 wherein each of said focused ultrasound transducer array elements is controlled by a separate signal generator and power amplifier.

4. The system of claim 1, wherein the signal acquisition device comprises a signal receiving module and a signal conversion module;

the signal receiving module is positioned around the focused ultrasound focus and used for acquiring tissue echoes generated by the target region under the stimulation of the focused ultrasound; the device is also used for acquiring a first reflection echo of the target point part at the beginning of ablation and acquiring a second or Nth reflection echo of the target point part in the ablation process; the device is also used for acquiring attenuation echoes of the target area and/or the target point part, wherein N is a positive integer greater than or equal to 3;

the signal conversion module is connected with the signal receiving module and is used for converting the tissue echo into a corresponding echo signal and respectively converting the first reflection echo and the second or Nth reflection echo into a first reflection signal and a second or Nth reflection signal; and also for converting the attenuated echo into an attenuated signal;

the signal conversion module is connected with the central processing equipment and sends the echo signal, the first reflection signal, the second or Nth reflection signal and the attenuation signal to the central processing equipment.

5. The system of claim 4, wherein the signal acquisition device is further configured to acquire and calculate an echo sound intensity or backscatter integral of the echo radio frequency signal, determine an acoustic attenuation of the focused ultrasound beam to the target site based on the echo sound intensity or backscatter integral, and send the acoustic attenuation to the feedback control device to adjust the operating parameters of the ultrasound emitting device.

6. The system of claim 1, wherein the imaging device comprises an imaging probe set and an imaging host;

wherein the imaging probe group comprises a plurality of imaging probes, and the arrangement mode of the imaging probes is as follows any one or more: i-shaped, cross-shaped, L-shaped, T-shaped and mouth-shaped; the imaging probe is used for sending imaging sound waves to the target area according to the imaging instruction sent by the imaging host and receiving imaging echoes; the imaging host is also used for acquiring the first texture information and the second or Nth texture information according to a texture information acquisition instruction sent by the imaging host;

the imaging host is used for constructing image information of the target area according to the imaging echo and calculating to obtain the texture information variable according to the first texture information and the second or Nth texture information.

7. The system of claim 6, wherein the imaging device is a multi-plane ultrasound imaging device for acquiring real-time Doppler blood flow information of a preset blood vessel in the target region and sending the real-time Doppler blood flow information to a central processing device; the central processing device is used for comparing the real-time Doppler blood flow information with preset reference Doppler blood flow information to obtain a comparison result; and the feedback control equipment is used for controlling the stepping motor to move when the comparison results of the central processing equipment are different until the comparison results of the central processing equipment are the same.

8. The system of claim 6, wherein the image information of the target area is in the form of any one or more of: grayscale images, color doppler images, virtual tissue images.

9. The system of claim 6, wherein the imaging device is further configured to detect a hyperechoic interface from the two-dimensional or three-dimensional image, and to alert and turn off the focused ultrasound transducer of the corresponding region when the hyperechoic interface is detected, so as to avoid tissue damage caused by ineffective energy release of the ultrasound transducer.

10. The system of claim 1, wherein the central processing device comprises a target location module and a temperature monitoring module;

the target point positioning module is specifically used for establishing the distribution information of the target point part in the target area by comparing the echo signal with a preset echo signal parameter;

the temperature monitoring module is specifically used for inputting the texture information variable into a preset temperature calculation model and constructing a temperature change parameter of the target point part in the ablation process.

11. The system of claim 10, wherein the distribution information of the target site comprises any one or more of a target distribution range, a target distribution density, and a target histopathological state.

12. The system of claim 1, wherein the feedback control device is specifically configured to generate the adjustment command by comparing the temperature change parameter to a preset temperature change parameter.

13. The system according to any one of claims 1-12, wherein the signal acquisition device is further configured to acquire an attenuated echo signal formed by the target region under the action of the focused ultrasound before ablation, convert the attenuated echo signal into an attenuated signal, and transmit the attenuated signal to the central processing device;

the imaging device is further used for determining boundary information formed by the focused acoustic beam in the target area before ablation, calculating to obtain a focused acoustic cone volume, and sending the focused acoustic cone volume to the central processing device;

the central processing device is further configured to calculate a focused ultrasound dose from the attenuation signal and the focused acoustic cone volume prior to ablation;

the ultrasonic transmitting equipment is used for determining the initial focused ultrasonic dose at the beginning of ablation according to the focused ultrasonic dose.

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