Ultrasonic diagnostic apparatus, shape estimating apparatus, and system including the apparatus

Abstract

To provide a method, a device and a program for obtaining signals from multiple directions without requiring scanning by a plurality of ultrasonic probes embedded in a mat wound around a body tissue, enabling a three dimensional structure model in a region of interest and its analysis, and transmitting them to a user and a sharer.SOLUTION: A plurality of ultrasonic probes 3 are embedded in a mat 2 which flexibly changes its shape and adheres to the surface of a body tissue. A plurality of ultrasonic reflection images transmitted and received by the ultrasonic probe 3 are integrated as a three dimensional structure model included in the region of interest by the arithmetic processing device 4. The morphology, kinetics, and composition of the three dimensional structural model are automatically evaluated by the program and the results are transmitted to the sharer via a display at the user's location or a remote system.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to an ultrasound examination device that does not require scanning with an ultrasound probe.The present invention also relates to a method, device, and program for reconstructing the three-dimensional structure of body tissue by irradiating ultrasound from multiple directions and evaluating its morphology and dynamics. [Background technology]

[0002] Ultrasound examinations involve scanning the surface of body tissue with an ultrasound probe held by a doctor or technician. High-quality, comprehensive imaging requires highly specialized skills, and there are limitations on the location and time of imaging. Furthermore, ultrasound irradiation from a single direction has limitations, such as the reflection of ultrasound from structures with high acoustic impedance, resulting in artifacts, and the attenuation of ultrasound as it travels deeper, making images unclear (Patent Documents 1 to 3). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Utility Model Application Publication No. 56-155808 [Patent Document 2] Japanese Patent Application Laid-Open No. 2005-137581 [Patent Document 3] Japanese Patent Application Laid-Open No. 2015-107311 Summary of the Invention [Problem to be solved by the invention]

[0004] Conventional ultrasound examinations (Patent Documents 1 to 3) require an operator in addition to the examinee. Furthermore, the examination results vary depending on the operator's level of skill, and the information on the position and angle at which the ultrasound probe scanned the surface of the body tissue is lost from the obtained moving images, resulting in problems with reproducibility and quantitation.

[0005] Therefore, the present invention aims to provide a device that allows the subject to perform the test without any special training by wrapping the device around the target body tissue and automatically analyzing and evaluating the obtained signals. [Means for solving the problem]

[0006] In order to achieve the above object, the present invention is characterized by the following invention-specific features.

[0007] In this invention, ultrasonic waves emitted from multiple ultrasonic probes are received by multiple ultrasonic probes, and a three-dimensional model is constructed by superimposing the common parts, allowing for structural evaluation within a region of interest without the need for automatic or manual scanning of the ultrasonic probes or the oscillation of the ultrasonic transducers within the probes.

[0008] In addition, in this invention, ultrasonic waves emitted from a single ultrasonic probe are received multiple times from different locations, and a three-dimensional model is constructed by superimposing common areas. The locations from which ultrasonic waves are transmitted and received multiple times are automatically calculated using machine learning or a predetermined method. Furthermore, when the probe recognizes the optimal timing and position, it transmits and receives ultrasonic waves. This allows for structural evaluation within a region of interest without the need for manual scanning of the ultrasonic probe or the oscillation of the ultrasonic transducer within the probe.

[0009] At least one ultrasound probe 3 is embedded in a flexible, adhesive, flat material (hereinafter referred to as a mat) that can be wrapped around body tissue. When there are multiple ultrasound probes 3, the multiple ultrasound probes 3 transmit and receive ultrasound waves at a time difference according to a certain frequency and phase so as not to interfere with each other. Ultrasound emitted from a certain probe and reflected within the body tissue is received by the transmitting probe and by probes located in different positions, and is integrated in time and space by a computing device to become the raw information for creating a three-dimensional structural model.

[0010] The orientation and position of the mat are specified for each classification of body tissue to be examined (neck, abdomen, thigh, etc.). Because the relative positions of the probes change depending on the shape of the surface of the body tissue to be examined, flexion and extension sensors are built into the mat, and the curvature and degree of extension of the mat are calculated from the signals from these sensors, which in turn estimate the relative positions and angles of the probes within the mat. Based on this, signals obtained from multiple pairs of probes in different positions are superimposed, and common regions of interest are spatially integrated in a manner similar to image stitching.

[0011] The system depicts dynamic changes in a three-dimensional structural model by repeatedly transmitting and receiving ultrasound from multiple directions and integrating the signals at high speed. By increasing the refresh rate sufficiently, it is possible to evaluate, for example, fetal breathing-like movements and limb movements within the pregnant abdomen, thereby assessing fetal health. Furthermore, the Doppler effect of ultrasound can be used to evaluate blood flow velocity, but in the past, ultrasound had to be incident parallel to the blood flow. This invention makes it possible to estimate the desired hemodynamics from any cross-section and angle in a three-dimensional structural model constructed by spatiotemporally integrating signals obtained from multiple directions.

[0012] The stiffness and composition of structures within body tissues are estimated by measuring the propagation velocity of shear waves generated by acoustic radiation pressure at angles different from the direction of ultrasound propagation. In this invention, the transmitting and receiving ultrasound probes are located at different angles and positions from the region of interest through which the ultrasound passes, making it possible to more quantitatively and three-dimensionally evaluate the stiffness and composition of body tissues, which was previously only possible with ultrasound probes positioned in a single direction.

[0013] If the density of ultrasonic probes arranged on a plane is sufficiently high, specifically if they are arranged at the same density as the ultrasonic vibrators in existing probes, comprehensive and highly accurate reflection images within the region of interest can be obtained. The 3D structural model constructed based on this is used as training data, and the system is trained to be able to construct equivalent models even with signals obtained from inspection equipment with gradually reduced probe arrangement densities on a plane. This allows the density of ultrasonic probes to be reduced without compromising performance, enabling cost-effective arrangement.

[0014] In this invention, the user wraps the mat around the target body tissue and performs the examination. If air gets between the mat and the surface of the body tissue, the difference in acoustic impedance causes diffuse reflection, attenuation, and interference of ultrasound, resulting in a reflection image (artifact) that differs from the actual body tissue. Therefore, tiny air holes and exhaust grooves are carved to allow air bubbles to escape at the location where the mat contacts the surface of the body tissue and where the ultrasound probe is not directly above. In addition, the processing unit is equipped with an algorithm that automatically detects ultrasound probes that are unable to completely expel air bubbles and cause artifacts, and excludes them from the integration and analysis of information.

[0015] The 3D structural model and its information on morphology, dynamics, hardness, and composition can be transmitted to a display on the user's screen or to a remote information sharer. Information that the user wishes to share can also be transmitted to an external network.

[0016] The present invention comprises a main body (ultrasound diagnostic device) consisting of a flat mat that is flexible, skin-compatible, adheres to the skin, is ultrasonically transparent, and durable, multiple ultrasound probes and their constituent ultrasound vibrators, a processing unit, a wireless or wired communication device, a wireless or wired power supply device, and flexion and extension sensors, and an information terminal device. The information terminal device includes an algorithm or artificial intelligence that constructs a three-dimensional structure within a region of interest for each examination and accumulated data for training the algorithm or artificial intelligence, an output interface as a display on the user's hand, a computer used by a remote information sharer, a cloud-based system, or a wireless or wired communication device.

[0017] The position and direction of the device are determined by the target tissue area. The user attaches the device to the tissue, and any air bubbles on the contact surface are naturally expelled through the fine holes and grooves on the surface of the mat. The acoustic impedance of the mat is similar to that of the human body, so ultrasound emitted from the ultrasound probe is transmitted to the tissue with minimal artifacts.

[0018] Ultrasound waves propagating through body tissue are reflected at areas where the acoustic impedance changes. The reflected waves are received by multiple probes, including the original transducer. Based on the ultrasound waves reflected at angles significantly different from the incident angle, the acoustic radiation pressure and shear wave propagation velocity are measured to estimate the stiffness and composition of structures within the body tissue. The ultrasound waves emitted from each ultrasound transducer are reflected, received, and attenuated, and the temporal and spatial differences are managed on the order of milliseconds or millimeters to prevent interference with the next ultrasound wave emitted. Each ultrasound transducer transmits and receives signals at a high refresh rate, capturing the morphology and changes within the body tissue.

[0019] By ensuring a sufficiently high refresh rate and an incident range that covers the region of interest, it is possible to capture the movements of body tissues (gallbladder contractions, digestive peristalsis, uterine contractions) that change over a period of several seconds to several tens of seconds.

[0020] By utilizing the Doppler effect and narrowing down measurements to the area of ​​interest, it is possible to capture hemodynamics and fetal heart rate, which change over a shorter period of time, as well as their instantaneous changes.

[0021] The signals obtained from multiple ultrasound probes are sent to an internal or external computing device via communication, where they are integrated into a three-dimensional structural model using an algorithm or trained artificial intelligence.

[0022] The relative positions and angles of each ultrasound probe are estimated using flexion and extension sensors within the mat. Furthermore, a 3D structural model of the region of interest is constructed by overlapping, smoothing, and interpolating common areas in the reflected images collected by adjacent ultrasound probes.

[0023] The algorithm or artificial intelligence that constructs the three-dimensional structural model learns optimal parameters based on accumulated data and is designed to ensure that performance does not deteriorate even with fewer input signals or computing resources, and is operated while taking into consideration a balance between robustness to noise, energy-saving performance, and accuracy.

[0024] The morphology, dynamics, stiffness, and composition of the three-dimensional structural model are automatically evaluated and displayed on a display at the user's hand, on a computer used by a remote information sharer, or on a cloud-based system. For example, the child's weight may be estimated from fetal head diameter, trunk circumference, and femur length, and health may be measured from respiratory movements, heart rate, limb and trunk movements, and amniotic fluid volume. These evaluation values ​​are calculated using formulas based on conventional medical knowledge, but are not limited to this. Evaluation values ​​may also be obtained using machine learning, with the obtained three-dimensional structural model as the explanatory variable and evaluation values ​​such as health and estimated weight as the objective variables.

[0025] If an abnormal value is found in the evaluation of the three-dimensional structural model, the abnormal value is communicated to the display on hand, the computer used by the remote information sharer, or a system on the cloud. [Effects of the Invention]

[0026] Because the system of the present invention does not require an operator, testing can be performed regardless of the limited availability of doctors and technicians, a field that is chronically in short supply. Eliminating the labor costs of medical professionals, who have high hourly rates, leads to lower testing fees, which is effective in promoting screening testing and early disease detection. Because it does not require human intervention, quantitative test results can be collected and compared, facilitating research based on big data that aggregates test results from multiple facilities. Furthermore, by reducing the labor required for testing in labor-intensive medical settings, it also leads to more time available for other tasks, such as treatment and patient explanations. Other benefits include shortening waiting times for test subjects in outpatient clinics and hospital wards and correcting regional disparities due to the availability of medical resources. [Brief explanation of the drawings]

[0027] [Figure 1] FIG. 1 is a block diagram illustrating one embodiment of the present invention. [Figure 2] FIG. 2 is an explanatory diagram showing a method for performing an examination by wrapping the main body around body tissue. [Figure 3]FIG. 3 is an explanatory diagram illustrating the arrangement of the mat, the plurality of probes, the bending sensor and the extension sensor, the arithmetic processing device, the wireless or wired power supply device, and the wireless or wired information and communication device that constitute the main body. [Figure 4] FIG. 4 is a flowchart showing an ultrasonic diagnostic method according to one embodiment of the present invention. [Figure 5] FIG. 5 is an explanatory diagram showing how multiple signals are integrated by a processing device in the main body or on the cloud to construct a three-dimensional structural model of the region of interest. DETAILED DESCRIPTION OF THE INVENTION

[0028] (Configuration of Ultrasound Diagnostic System) FIG. 1 shows, as a block diagram, the overall configuration of an ultrasound diagnostic system optimal for implementing the present invention. The main unit (ultrasound diagnostic device) can be installed anywhere, from a medical institution to a patient's home. In this embodiment, the region of interest is the upper abdomen, and a three-dimensional structural model of the liver is shown as an example. Note that in the present invention, the ultrasound diagnostic system configures a three-dimensional structural model of the liver, but is not limited to this. The system may also be configured to acquire a three-dimensional structural model of a fetus, as well as three-dimensional structural models of organs other than the liver, or soft tissues such as the thyroid gland or muscle mass of the limbs. In this case, the ultrasound diagnostic device described below is attached to a region of interest that allows observation of the fetus, organs other than the liver, the neck, or the limbs, rather than the upper abdomen.

[0029] 1, the ultrasound diagnostic system of this embodiment includes an ultrasound diagnostic apparatus and an information terminal device. The ultrasound diagnostic apparatus includes a mat 2, an ultrasound probe 3, a flexion / extension sensor 7, a processing unit 4, a power supply unit 6, and a communication unit 5. The morphology and dynamics of a three-dimensional structural model defined by a signal transmitted from the ultrasound probe 3 or by the processing unit 4 (a general-purpose computer or a cloud-based system) are evaluated by the processing unit 4, transmitted to the communication unit 8 of the information terminal device via wireless or wired communication, and displayed on a display (output interface) on the user's side of the information terminal device or to a remote sharer.

[0030] Figure 2 shows a subject in a supine position wearing the mat 2 on their abdomen. The mat 2 is approximately 30-40 cm wide and 20-30 cm long, and the arithmetic processing unit 4 or power supply unit 6 can be separated from the main body to avoid burdening the subject if weight becomes an issue. In Figure 2, the power supply unit 6 and communication unit 5 are integrated with the arithmetic processing unit 4 and are connected via wires to the ultrasound probe 3 installed (preferably contained within) in the mat 2. To prevent interference with ultrasound transmission and reception, the contact surface between the mat 2 and the body tissue 1 is finely textured to prevent air bubbles from forming or to allow them to be naturally expelled. If unevenness due to body hair, scars, or protrusions on the skin cannot be avoided, a commercially available echo jelly with an acoustic impedance similar to that of the human body can be applied separately.

[0031] In Figure 2, the subject is in a supine position, but by securing the device to the back or shoulders with a belt, the examination can be performed while the subject is standing, sitting, or walking. This makes it possible to verify how gravity and the subject's body movements affect the organs and fetus within the region of interest.

[0032] Figure 3 shows an example of the arrangement and connection of each part that makes up the main body. Mat 2 flexibly changes shape to match the target body tissue 1, and ultrasonic waves are incident so as to surround the region of interest. A flexion / extension sensor 7 is installed inside mat 1 to estimate the relative position and angle of the ultrasonic probe 3.

[0033] Regarding the installation position of the ultrasonic probe 3, from the viewpoint of efficiently acquiring a region of the human body with ultrasonic waves spreading in a substantially conical shape, it is preferable to arrange the ultrasonic probe 3 in a planar lattice structure or a hexagonal close-packed structure. For example, it is preferable that the ultrasonic probes 3 are arranged at angles of approximately 60 degrees or approximately 90 degrees to each other to form a lattice structure or a honeycomb structure, and the ultrasonic probe 3 is arranged at the center of the lattice structure or honeycomb structure.

[0034] Furthermore, since the angle of the approximately conical spread is determined by the shape of the cone portion of the ultrasonic probe 3, it is preferable to configure an angle of 30° to 120° depending on the shape of the cone portion. Furthermore, from the viewpoint of improving measurement accuracy, it is preferable that at least two piezoelectric elements are integrated in the ultrasonic probe 3.

[0035] The ultrasound diagnostic apparatus may calculate an optimal arrangement of the ultrasound probes 3 before arranging them. For example, the ultrasound diagnostic apparatus may estimate the arrangement of the ultrasound probes 3 by maximizing the number of ultrasound probes 3 that include any curved surface in the tissue to be diagnosed within their irradiation range, and then arrange the ultrasound probes 3. This allows for calculating an arrangement that refines the resolution of the 3D model under the constraint of the upper limit number of ultrasound probes 3, thereby increasing the 3D model resolution as much as possible.

[0036] The flexion / extension sensors 7 are preferably arranged so as to connect the ultrasonic probes 3 in a layer distal to or at the same depth as the ultrasonic probes 3 when viewed from the surface of the body tissue 1. For example, when the ultrasonic probes 3 are arranged at the center points of a lattice structure at approximately 90-degree angles to each other as shown in Fig. 3, the flexion / extension sensors 7 are preferably arranged at the midpoints of each center point of the honeycomb structure. Alternatively, the flexion / extension sensors 7 may be laid out in a lattice pattern completely independent of the arrangement of the ultrasonic probes 3. In this case, in order to suppress interference with the position of the ultrasonic probes 3, it is preferable to place the flexion / extension sensors 7 in a layer shallower than the ultrasonic probes 3.

[0037] In addition, the arrangement and integration density of the ultrasonic probe 3 differ depending on the purpose of the inspection and the required accuracy. If high spatial resolution is required, a device with high integration density is used, and if the purpose is to measure the gross movement and size of structures within the region of interest, a device with low integration density is used. This allows for a balance between the required performance and cost.

[0038] Furthermore, the arrangement method or performance of the ultrasonic probe 3 and the flexion / extension sensor 7 may be determined by simulation within a desired range.

[0039] The arithmetic processing unit 4 and communication unit 5 can be built-in or removable depending on the purpose. When the purpose is to measure for a short period of time during exercise, weight can be reduced and energy can be saved by removing heavy parts. Power can also be supplied by a removable built-in battery or by wire.

[0040] (Ultrasound diagnostic method) Next, an ultrasonic diagnostic method performed by the ultrasonic diagnostic system of the present invention will be described.

[0041] Each of the multiple ultrasonic probes 3 includes an output unit 31 that generates ultrasonic waves and an input unit 32 that acquires ultrasonic waves. Here, the ultrasonic waves generated by the output unit 31 are preferably pulse waves, and the frequency of the pulse waves is preferably 1.5 MHz to 10 MHz, the pulse width is preferably 16 to 512 nanoseconds, the pulse repetition period is preferably 0.2 to 64 Hz, and the ripple length is preferably 1 to 15.

[0042] Each of the multiple ultrasonic probes 3 may generate ultrasonic waves of the same type, but the input unit may generate ultrasonic waves of different types to identify each of the multiple ultrasonic probes 3. Additionally, even when generating ultrasonic waves of the same type, each of the multiple ultrasonic probes 3 may be distinguished from each other by generating ultrasonic waves from each of the ultrasonic probes 3 at a predetermined time interval (for example, 50 microseconds to 10 milliseconds, more preferably 100 microseconds to 400 microseconds).

[0043] When a portion of the ultrasonic waves (input waves) generated by the output unit 31 reaches the tissue to be diagnosed, they are reflected on the surface of the tissue to be diagnosed, forming a reflected wave. Another portion of the input waves is diffused on the surface of the tissue to be diagnosed, forming a diffused wave. Another portion of the input waves is not reflected or diffused, but passes through the body as a transmitted wave. In addition, the input waves are refracted due to changes in the density of the body tissue, forming a refracted wave. The input unit 32 detects at least one of the reflected wave, diffused wave, transmitted wave, and refracted wave. At the same time, the input unit 32 or the calculation processing device 4 distinguishes at least one of the reflected wave, diffused wave, transmitted wave, and refracted wave.

[0044] The reflected wave is used to estimate the position and normal of a specific target point on the surface of the tissue to be diagnosed. That is, an input wave emitted from the output unit 31 of one ultrasonic probe 3 is reflected at the target point, and the reflected wave is detected by the input unit 32 of another ultrasonic probe 3 (if the direction of the input wave is parallel to the direction of the normal at the target point, it is the one ultrasonic probe 3), and a position vector t from the output unit 31 of the one ultrasonic probe 3 to the specific target point on the surface of the tissue to be diagnosed is calculated. → ("● → " is the vector notation of "●") and the normal unit vector n of the target point → where the position vector t → satisfies the following equation (1), and the normal unit vector n → satisfies the following formula (2).

[0045] p → =t → +r → ··(1).

[0046] n → =s → +r → ··(2).

[0047] Here, "p →" is a position vector from the output part 31 of one ultrasonic probe 3 to the input part 32 of another ultrasonic probe 3. The other ultrasonic probe 3 here is an ultrasonic probe 3 that detects a reflected wave of an input wave, and is therefore the ultrasonic probe 3 that observed the ultrasonic wave with the greatest intensity among the multiple ultrasonic probes 3. "r → " is the unit vector of the reflected wave arriving at the input section 32 of another ultrasonic probe 3. → " is the unit vector of the input wave emitted from the output section 31 of one ultrasonic probe 3. Furthermore, equation (1) can be transformed into the following equation (3).

[0048] p → =t → +r → =l t s → +l r r → ··(3).

[0049] Here, "l t ” is the position vector t → The magnitude of the distance (i.e., the distance from one ultrasonic probe 3 to the target point) is also r " is the position vector r → (i.e., the distance from the other ultrasonic probe 3 to the target point). Furthermore, the input wave unit vector s → and the reflected wave unit vector r → Since the following equation (4) is satisfied, the input wave unit vector s → and the normal unit vector n → The angle θ between them can be calculated.

[0050] s → ·r → =cos2θ ··(4).

[0051] (The "·" indicates a vector dot product operation.)

[0052] Also, the distance l t and distance l r The following equation (5) holds true:

[0053] l t +l r =cT ··(5).

[0054] Here, "c" is the speed of sound of ultrasound inside the body, which is usually 1400 to 1600 m / sec, depending on the frequency and tissue. The speed of sound in some tissues, such as bone, is calculated as 3500 to 4500 m / sec. "T" is the time from when an input wave is emitted from the output unit 31 of one ultrasound probe 3 to when the reflected wave is detected by the input unit 32 of another ultrasound probe 3.

[0055] From the above-described equations (1) to (5), the known sound speed c, time T, and input wave unit vector s → , reflected wave unit vector r → and the position vector p → From the position vector t → and the normal unit vector n of the target point → can be estimated.

[0056] Furthermore, the reflected wave is reflected at either a fixed end or a free end depending on the difference in acoustic impedance between the organ or fetus and the body tissue surrounding the organ or fetus. By taking into account the fixed end or free end reflection and the phase fluctuation of the pulse wave, it is possible to distinguish it from a refracted wave, which will be described later.

[0057] Diffused waves are used to precisely estimate the position and normal of a specific target point on the surface of the target tissue in a plane where Lambertian reflection is assumed. In the plane where Lambertian reflection is assumed, a portion of the input wave is diffused by Lambertian reflection, which is uniformly diffused over a hemisphere. Here, it is known that the reflectance of Lambertian reflection satisfies the following equation (6):

[0058] i=ρn → ·s → ··(6).

[0059] Here, "i" is the Lambertian diffuse reflectance, and "ρ" is the proportionality constant determined for each material of the object. Thus, the Lambertian diffuse reflectance i is calculated by dividing the input wave unit vector s →and the normal unit vector n → Since it depends on the input wave unit vector s → By assuming a constant Lambertian diffuse reflectance, the normal unit vector n → Furthermore, the roughness of the target point can also be estimated from the Lambertian diffuse reflectance at the target point.

[0060] The transmitted wave, together with the refracted wave, is used to estimate the acoustic impedance (density distribution) inside the body tissue. The input wave generated at the output section 31 of the ultrasound probe 3 may be refracted depending on the acoustic impedance difference inside the body tissue. Furthermore, a part of the input wave may be transmitted without being refracted, reflected, or diffused.

[0061] The relative angle (input wave unit vector s → and the normal unit vector n → angle θ) and distance (position vector p → The magnitude of the wave propagation distance (wave amplitude) can be obtained using the method described above, from which information on the refraction or straightness of the input wave can be obtained. The time it takes for the input wave to propagate between the ultrasonic probes 3 can be obtained from actual data. The speed of sound on the ultrasonic path can be calculated from the distance and propagation time between one ultrasonic probe 3 and another. Since the speed of sound depends on the density of the object through which the wave propagates, it is possible to estimate the average density of the object on the path. By calculating this average density on the path between multiple ultrasonic probes 3, it is possible to calculate the density distribution of any region inside body tissue.

[0062] Next, a method for generating a three-dimensional model of a tissue to be diagnosed and a method for estimating the mass of the three-dimensional model of the tissue to be diagnosed in the ultrasonic diagnostic system of the present invention will be described.

[0063] 4 is a flowchart showing the 3D model generation method and the mass generation method for the generated 3D model of the present invention. First, the diagnostic method of the ultrasound diagnostic device is started by turning on the power of the ultrasound diagnostic device (FIG. 4 / SSTART).

[0064] Next, it is determined whether the ultrasound diagnostic device has been attached correctly (FIG. 4 / STEP 1). This determination is made by automatic determination using the signal-to-noise ratio, automatic determination using the curvature of the ultrasound diagnostic device calculated using multiple flexion / extension sensors 7 (for example, the clinically possible curvature of the pregnant abdomen is in the range of R = 150 mm to 400 mm), automatic determination using detection of a local degree of flexion that significantly deviates from the sphere or a degree of flexion in the opposite direction, automatic determination using detection of the front and back using a level (not shown), automatic determination using detection of the cranial and caudal sides utilizing the fact that the upper border of the pubic bone is thicker than the lower end of the sternum, etc. Note that STEP 1 may be performed after manual determination, or STEP 1 itself may be omitted.

[0065] If the determination is negative (FIG. 4 / STEP 1·NO), the ultrasound diagnostic apparatus returns to the previous operation and is controlled to execute STEP 1 again. At this time, a notification device may be used to notify the user of the exact position. On the other hand, if the determination is positive (FIG. 4 / STEP 1·YES), 1 is assigned to the identifier i (FIG. 4 / STEP 2).

[0066] Next, a specific input wave is generated in the ith ultrasonic probe 3 among the multiple ultrasonic probes 3 (FIG. 4 / STEP 3). As explained above, the input wave is preferably a specific pulse wave, and its frequency, amplitude, phase, waveform, etc. may be changed depending on i. Also, a pulse wave may be formed by combining multiple sine waves, and when the pulse wave is Fourier transformed, the frequency, wave number, etc. may be made dependent on i. Note that the input wave may be generated multiple times to ensure the reliability of the data. In this case, each input wave may be different or the same for each time.

[0067] The arrangement and identification numbers of the ultrasonic probes 3 may be determined according to the arrangement of the ultrasonic probes 3. That is, among the ultrasonic probes 3 arranged in a lattice pattern, the ultrasonic probe 3 located in the first row and first column is determined as the first ultrasonic probe, and the ultrasonic probe 3 located in the j-th row and k-th column is determined as the (ΣJ k-1 +k) ultrasonic probe 3 may be defined as (J k-1 is the total number constituting the k-1 column). In addition, for example, the ultrasonic probe 3 located in the center may be designated as the first ultrasonic probe, and identification numbers may be assigned in a spiral pattern.

[0068] Alternatively, the ultrasonic probe 3 in the first row and first column may be defined as the first ultrasonic probe, and the ultrasonic probe farthest from the first ultrasonic probe 3 may be defined as the second ultrasonic probe 3. That is, the i-th ultrasonic probe 3 may also be the farthest, and an ultrasonic probe 3 other than the first ultrasonic probe 3 to the (i-1)th ultrasonic probe 3 may be defined as the (i+1)th ultrasonic probe. In this case, the input wave of the i-th ultrasonic probe 3 weakens near the (i+1)th ultrasonic probe, so the (i+1)th ultrasonic probe can generate an input wave with reduced noise. Furthermore, because the input wave of the i-th ultrasonic probe 3 weakens near the (i+1)th ultrasonic probe, the ultrasonic probe switching condition (described later) is quickly satisfied, which also leads to a reduction in the ultrasonic diagnosis time.

[0069] In addition, the distance D between the i-th ultrasonic probe and the i+1-th ultrasonic probe is i Then, add up until i+1 reaches N, (ΣD i ) (i=1, N-1) may be assigned an arbitrary identification number that maximizes the relative angle between the i-th ultrasonic probe and the (i+1)-th ultrasonic probe (input wave unit vector s → and the normal unit vector n →It is preferable to assign identification numbers after considering whether there are any interference waves or multiple reflections that are likely to remain due to the angle θ between the i-th ultrasonic probe and the i+1-th ultrasonic probe. In this case, the input wave is output from the (i+1)-th ultrasonic probe after reducing the influence of interference waves or multiple reflection waves of the input wave output from the i-th ultrasonic probe. Furthermore, by controlling the irradiation order using such identification numbers, the time efficiency of ultrasound diagnosis can be improved.

[0070] In addition to the above-mentioned method of assigning identification numbers, the identification numbers may be assigned spatially randomly, or may be assigned in a concentrated manner to a certain part of the survey subjects so as to cause bias depending on the survey subjects.

[0071] After the input waves are generated, they are input as reflected waves, diffusing waves, transmitted waves, or refracted waves to multiple ultrasonic probes 3. At this time, the reflected waves, diffusing waves, transmitted waves, or refracted waves are stored in a storage unit (not shown) as parameters for generating a three-dimensional model or three-dimensional density distribution (described later). Thereafter, it is determined whether the ultrasonic probe switching conditions are met (FIG. 4 / STEP 4).

[0072] Here, the "ultrasonic probe switching condition" refers to a condition under which the ultrasonic probe 3 that generates the input wave is switched from the ith ultrasonic probe 3 to the (i+1)th ultrasonic probe 3. The ultrasonic probe switching condition is, for example, a condition that is met when a certain time has elapsed since the ith ultrasonic probe 3 generated the input wave. In addition, the ultrasonic probe switching condition may be, for example, met when ultrasonic waves reach a receiving probe including the ith ultrasonic probe.

[0073] Next, i+1 is substituted for the identifier i (FIG. 4 / STEP 5), and it is determined whether the current identifier i is N (FIG. 4 / STEP 6). "N" is preferably the total number of ultrasound probes 3 inserted in the ultrasound diagnostic device, but may also be the minimum number of data collections that can acquire sufficient ultrasound probe data to generate a 3D model or a 3D density distribution. In other words, "N" may be less than the total number of ultrasound probes 3 inserted in the ultrasound diagnostic device.

[0074] If the determination is negative (FIG. 4 / STEP 6··NO), the process returns to the step immediately before STEP 3, and the process from STEP 3 onward is executed again. On the other hand, if the determination is positive (FIG. 4 / STEP 6··YES), the process from STEP 7 onward is executed.

[0075] In STEP 7, the ultrasound diagnostic device generates a 3D model of the tissue to be diagnosed (FIG. 4 / STEP 7). Specifically, the information acquired in STEPs 3 to 4 is classified into at least one of reflected waves, diffuse waves, transmitted waves, and refracted waves, and at least one of the positions of the multiple target points in real coordinates, the normal unit vectors of the multiple target points, the roughness of the multiple target points, and the density of the multiple target points is acquired from the at least one of the reflected waves, diffuse waves, transmitted waves, and refracted waves. Then, a 3D model of the tissue to be diagnosed is generated from the at least one of the positions of the multiple target points in real coordinates, the normal unit vectors of the multiple target points, the roughness of the multiple target points, and the density of the multiple target points.

[0076] Furthermore, although this may be omitted, before, after, or in parallel with STEP 7, a three-dimensional density distribution of the diagnostic target tissue may be generated from at least one piece of information among the positions of the multiple target points in real coordinates, the normal unit vectors of the multiple target points, the roughness of the multiple target points, and the density of the multiple target points (Figure 4 / STEP 8).

[0077] Next, the mass of the 3D model is generated (FIG. 4 / STEP 9), and the ultrasound diagnostic method of the present invention ends (FIG. 4 / END). The mass of the 3D model may be calculated by integrating the density of each target point for each minute volume from the 3D model and the 3D density distribution. However, this is not limited to this method. For example, it may be calculated from any cross-sectional area of ​​the 3D model using a literature formula or statistical data. For example, the volume, shape, or mass of the diagnostic target tissue may be estimated based on at least one of the major axis, minor axis, cross-sectional area, circumference, curvature, and distance of any cross-section of the 3D model. For example, in the case of a fetus, the mass may be calculated using the following formula (7), which is recommended by the Japan Society of Ultrasonics in Medicine, or Shinozuka's formula.

[0078] Estimated fetal weight (g) = 1.07 × fetal head diameter (cm) 3 +0.30 x abdominal circumference (cm) 2 ×Femoral length (cm) ··(7).

[0079] That is, the mass may be calculated by automatically measuring the fetal head diameter, abdominal circumference, and femur length from the 3D model.In addition, machine learning or deep learning may be used in which at least one of the information on the actual positions of the plurality of target points, the normal unit vectors of the plurality of target points, the roughness of the plurality of target points, and the density of the plurality of target points is used as an explanatory variable, and at least one of the 3D model of the diagnostic target tissue, the 3D density distribution, and the mass of the diagnostic target tissue is used as a target variable.

[0080] Furthermore, although not shown, the processes from STEP 1 to STEP 9 described above may be repeated 0.2 to 64 times per second, preferably 2 to 16 times per second, to capture temporal changes in the surface shape and mass of the 3D model of the tissue to be diagnosed and estimate its dynamics.The morphology (volume, shape, mass) and dynamics (temporal changes in each of the volume, shape, and mass) of the tissue to be diagnosed may be compared with clinical criteria or diagnostic standards to determine whether it is normal or abnormal, and further, the degree of abnormality may be determined.

[0081] Figure 5 shows the three-dimensional structural model of the liver within the region of interest estimated using the above method, along with the collection of ultrasound reflection images from multiple directions used to construct it. In this embodiment, the model evaluates liver morphology, the course and hemodynamics of the vascular system, including the hepatic artery, hepatic vein, and portal vein, gallbladder contraction, liver tissue stiffness and degree of fibrosis, fatty deposits using hepatorenal contrast, and liver mobility and adhesion due to breathing or body movement.

[0082] Each evaluation item is presented in general terms and indicators so that non-healthcare professionals can understand it, while more specialized terms and indicators are provided to healthcare professionals who share the information.

[0083] Data from consenting subjects is stored in on-board memory or on the cloud and used to optimize algorithms or artificial intelligence to build three-dimensional structural models.

[0084] The automatic inspection method, device, and program using the ultrasonic probe 3 of the present invention have been described above based on the embodiments, but the present invention can be used within the scope of the object and technical scope of the present invention in addition to the above-mentioned embodiments. Furthermore, the examples and usage examples of the present invention can be easily modified and altered by those skilled in the art within the scope of modification and alteration. [Industrial Applicability]

[0085] The automatic examination method, device, and program of the present invention using the ultrasonic probe 3 arranged on a plane do not require an operator other than the subject, so examinations can be performed regardless of the availability of medical institutions or medical professionals, and body tissues can be evaluated quickly and automatically, which is expected to lead to the following industrial applications:

[0086] It can be used to screen for the presence or absence of diseases or disabilities and determine the severity of the illness, thereby helping to allocate human resources efficiently in areas with a shortage of medical care, such as remote islands and rural areas, and in urban areas during times of tight supply compared to demand due to pandemics or disasters, as well as in medical departments such as emergency departments, obstetrics and gynecology, surgery, internal medicine, pediatrics, and home medical care, where there are insufficient medical professionals to treat the number of patients.

[0087] Unlike tests conducted in outpatient clinics or hospital wards, subjects can complete the test themselves, which reduces the risk of exposure to infectious diseases due to fewer opportunities for contact and enables rapid testing without waiting times.

[0088] By providing a variety of sizes of devices, it is possible to perform examinations of the neck, limbs, abdominal organs, pelvic organs, pregnant abdomen and fetus, and fetal appendages. Evaluating the course of arteries and veins, as well as stenosis, thrombus, and blood flow disorders, can provide information suitable for preventing infarction and planning rehabilitation. Evaluating peristalsis of the lower gastrointestinal tract and the composition of intestinal contents can prevent intestinal obstruction and improve bowel control. Examination of the cervical thyroid gland allows for simultaneous evaluation of size, shape, and composition, enabling faster examinations and reducing the number of personnel required.

[0089] In the pregnant abdomen, fetal reserve can be estimated by evaluating fetal respiratory movements, limb and trunk movements, heart rate, and the amount of amniotic fluid in the uterus. Furthermore, by estimating the intensity of labor from the dynamics of the entire uterus, more detailed and immediate clinical information can be obtained than with the cardiotocography, which is widely used in pregnancy and labor management.

[0090] The above will enable early detection and alerting of pathologies that progress within minutes to tens of minutes from onset and can lead to fetal cerebral palsy and perinatal death. Early detection will lead to early intervention and contribute to improving perinatal outcomes.

[0091] This system does not require an operator other than the subject, and because the main unit is in close contact with the body tissue, the subject's position is not limited to the supine position typically taken in examinations, but can be performed while standing, sitting, or walking.

[0092] The moving images, three-dimensional structural models, and evaluation values ​​obtained with this system are more quantitative than those obtained by human inspection, making it possible to conduct research and education based on the accumulated data.

[0093] The video images, three-dimensional structural models, and evaluation values ​​obtained with this system can be shared via social networking services, etc., if desired by the user.

[0094] By using electromagnetic waves as the signals and targeting mechanical structures and buildings, this system can also be used to check the internal structure of easily portable machines and buildings. [Explanation of symbols]

[0095] 1 body tissue 2 Matt 3 Ultrasonic probe 4. Processing Unit 5. Communication equipment (ultrasound diagnostic equipment) 6 Power supply equipment 7 Flexion / extension sensor

Claims

1. A flexible mat and and at least one ultrasonic probe arranged in a plane within the mat. Ultrasound diagnostic equipment.

2. 2. The ultrasonic diagnostic apparatus according to claim 1, The mat is ultrasonically transparent, The mat is characterized in that it is provided with an exhaust section for exhausting air bubbles generated at the surface that comes into contact with the surface of body tissue. Ultrasound diagnostic equipment.

3. 2. The ultrasonic diagnostic apparatus according to claim 1, The mat is characterized in that it is provided with a fixing portion that is fixed to at least a part of the surface of the body tissue. Ultrasound diagnostic equipment.

4. 2. The ultrasonic diagnostic apparatus according to claim 1, The ultrasonic probe is installed on the mat. Ultrasound diagnostic equipment.

5. 2. The ultrasonic diagnostic apparatus according to claim 1, The ultrasonic probe transmits and receives ultrasonic waves according to a certain frequency and phase. Ultrasound diagnostic equipment.

6. 2. The ultrasonic diagnostic apparatus according to claim 1, The ultrasonic probe transmits and receives ultrasonic waves at optimal timing and position. Ultrasound diagnostic equipment.

7. 2. The ultrasonic diagnostic apparatus according to claim 1, Calculating an optimal arrangement of the ultrasonic probe Ultrasound diagnostic equipment.

8. 2. The ultrasonic diagnostic apparatus according to claim 1, and a processing unit that constructs a three-dimensional structural model based on the parameters acquired by the ultrasonic probe. Ultrasound diagnostic equipment.

9. 2. The ultrasonic diagnostic apparatus according to claim 1, The ultrasonic wave probe is provided with a bending sensor for identifying the position of the ultrasonic probe. Ultrasound diagnostic equipment.

10. A shape estimation device for estimating the shape of a three-dimensional structure, An adhesive member that is brought into close contact with the surface of the target tissue; and at least one signal transceiver installed on a plane of the contact member. Shape estimation device.

11. The shape estimation device according to claim 10, a processing unit that constructs a three-dimensional structural model based on the parameters obtained by the signal transmitter / receiver; Shape estimation device.

12. The shape estimation device according to claim 11, The calculation processing unit constructs a three-dimensional structural model by machine learning based on the parameters. Shape estimation device.

13. The shape estimation device according to claim 11, The calculation processing unit recognizes at least one of the morphology, kinetics, and composition of the entire or part of the three-dimensional structural model. Shape estimation device.

14. A system comprising the shape estimation device according to any one of claims 10 to 13 and an information terminal device, A system that transmits the three-dimensional structural model identified by the shape estimation device to the information terminal device.

15. 15. The system according to claim 14, further comprising an anomaly detection device that detects an anomaly in the three-dimensional structural model, a system for transmitting an anomaly detected by the anomaly detection device to either the information terminal device or the shape estimation device;

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