Ultrasound diagnostic apparatus, shape estimation apparatus, and system including same

Abstract

Provided are a method, a device, and a program for obtaining signals from a plurality of directions without scanning by means of a plurality of ultrasound probes embedded in a cushion wound around body tissue, enabling a three-dimensional structure model in a region of interest and analysis thereof, and transmitting the model to a user and a sharer. A plurality of ultrasonic probes (3) flexibly change shapes and are embedded in a pad (2) attached to the surface of body tissue. A plurality of ultrasonic reflection images transmitted and received by an ultrasonic probe (3) are integrated into a three-dimensional structure model included in a region of interest by an arithmetic processing device (4). The form, the dynamic state and the composition of the three-dimensional structure model are automatically evaluated through a program, and the result is sent to a sharer through a display on the hand of a user or a remote system.

Description

[Technical Field]

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

[0002] In ultrasonic inspection, an ultrasonic probe held by a physician or a technician scans the surface of body tissue to form an image. Good and comprehensive imaging requires a high level of expertise and is limited in terms of the implementation location and time. In addition, in ultrasonic irradiation from a single direction, there are also limitations such as ultrasonic waves being reflected by a structure with a high acoustic impedance to generate artifacts, and as the ultrasonic waves travel deeper, they attenuate and the image becomes unclear (Patent Documents 1 to 3).

[0003] Prior Art Documents

[0004] Patent Documents

[0005] Patent Document 1: Japanese Utility Model Laid-Open No. 56-155808

[0006] Patent Document 2: Japanese Patent Laid-Open No. 2005-137581

[0007] Patent Document 3: Japanese Patent Laid-Open No. 2015-107311 [Summary of the Invention]

[0008] Problems to be Solved by the Invention

[0009] In conventional ultrasonic inspections (Patent Documents 1 to 3), in addition to the subject, an operator is also required. Moreover, the inspection results deviate due to the proficiency of the operator. In addition, the obtained dynamic image results lack information on which position and at which angle the ultrasonic probe scanned the surface of the body tissue, and there are problems in terms of reproducibility and quantitativeness.

[0010] Therefore, an object of the present invention is to provide a device in which the subject himself / herself wraps the device around the body tissue to be inspected as a user, automatically analyzes and evaluates the obtained signals, and thus can perform the inspection without special training.

[0011] Means for Solving the Problems

[0012] In order to achieve the above object, the present invention is characterized by having the following technical features.

[0013] In the present invention, multiple ultrasonic probes receive ultrasonic waves emitted from multiple ultrasonic probes, and a three-dimensional model is constructed by superimposing common parts, thereby evaluating the structure in the region of interest without the need for automatic or manual scanning of the ultrasonic probes or the swinging of the ultrasonic transducers in the probes.

[0014] In addition, in the present invention, ultrasound waves emitted from a single ultrasound probe are received multiple times from different parts, thereby constructing a three-dimensional model by superimposing common parts. At this time, the parts where ultrasound waves are transmitted and received multiple times are automatically calculated by machine learning or a predetermined method. In addition, at this time, when the probe recognizes the best time and position, the probe transmits and receives ultrasound waves. In this way, the structure evaluation in the region of interest is performed without manual scanning of the ultrasound probe or swinging of the ultrasound vibrator in the probe.

[0015] At least one ultrasonic probe 3 is built into a flat material (hereinafter referred to as a pad) having softness and fit for wrapping around body tissue. When there are multiple ultrasonic probes 3, the multiple ultrasonic probes 3 transmit and receive ultrasonic waves at a fixed frequency and phase with a time difference so as not to interfere with each other. Ultrasonic waves transmitted from a certain probe and reflected in body tissue are received by the probe of the transmission source and the probes at different positions, and are integrated in time and space by the computing device as raw information to create a three-dimensional structure model.

[0016] The direction and position of wearing the pad are specified for each category of body tissue to be examined (neck, abdomen, thigh, etc.). The relative positional relationship of the probes changes according to the shape of the surface of the body tissue to be examined, so flexion sensors and extension sensors are built into the pad, and the curvature and extension of the pad are calculated based on their signals, and the relative positional relationship and angle of the probes in the pad are estimated. Based on this, the signals obtained from multiple pairs of probes in different positions are superimposed, and the common area of ​​interest is spatially integrated according to the principle of image stitching.

[0017] The dynamic changes of the three-dimensional structural model are depicted by repeatedly transmitting and receiving ultrasound from multiple directions and integrating the signals at high speed. By sufficiently increasing the refresh rate, it is possible to evaluate, for example, the breathing-like movements of the fetus in the pregnant abdomen, the movements of the limbs, and the health of the fetus. In addition, the Doppler effect of ultrasound can be used to evaluate the blood flow velocity, but in the past, ultrasound waves had to be projected parallel to the blood flow. In the present invention, in the three-dimensional structural model constructed by integrating the signals obtained from multiple directions in time and space, the target blood flow dynamics can be estimated based on any section and angle.

[0018] The hardness and composition of a structure within body tissue are estimated by measuring the propagation speed of shear waves generated by acoustic radiation pressure generated at an angle different from the traveling direction of ultrasonic waves. In the present invention, the ultrasonic probes on the transmitting side and the receiving side are present at different angles and positions from the region of interest through which the ultrasonic waves pass, and thus it is possible to more quantitatively and three-dimensionally evaluate the hardness and composition of body tissue, which are limitedly obtained in ultrasonic probes arranged in a single direction.

[0019] If the density of ultrasonic probes arranged on a plane is sufficiently increased, specifically, if they are laid out to the same extent as the density of ultrasonic oscillators in existing probes, a comprehensive and highly accurate reflection image within the region of interest can be obtained. Using the three-dimensional structure model constructed on this basis as teacher data, the system is made to learn so that even signals obtained from an inspection device with a gradually reduced probe configuration density on the plane can be used to construct an equivalent model. As a result, it is possible to reduce the density of ultrasonic probes without degrading performance and achieve a cost-effective configuration.

[0020] In the present invention, the user wraps a pad around the body tissue to be inspected by themselves. When air enters between the pad and the body tissue surface, due to the difference in acoustic impedance, ultrasonic waves will undergo diffuse reflection, attenuation, and interference, generating a reflection image (artifact) different from the original body tissue. Therefore, fine air holes and discharge grooves for discharging air bubbles are engraved at positions where the pad is in contact with the body tissue surface and there is no ultrasonic probe directly above. In addition, for ultrasonic probes where artifacts are generated due to incomplete discharge of air bubbles, an algorithm for automatically detecting them and excluding them from the integration and analysis of information is incorporated into the arithmetic processing device.

[0021] Information on the three-dimensional structure model and its form, dynamics, hardness, and composition is sent to a display at the user's hand or an information sharer located remotely. Regarding information that the user wishes to share, it can also be sent to an external network.

[0022] The present invention consists of a main body (ultrasonic diagnostic device) and an information terminal device. The main body includes a planar pad having flexibility, skin affinity, skin adhesiveness, ultrasonic wave transmissibility, and durability, a plurality of ultrasonic probes and ultrasonic oscillators constituting them, an arithmetic processing device, a wireless or wired communication device, a wireless or wired power supply device, and a flexion and extension sensor. The information terminal device includes an algorithm or artificial intelligence for constructing a three-dimensional structure within the region of interest for each inspection and cumulative data for making them learn, an output interface serving as a display at the user's hand, a computer used by an information sharer located remotely, a system on the cloud, or a wireless or wired communication device.

[0023] The main body determines the wearing position and direction according to the body tissue part being the object. The user wears the main body around the body tissue by himself / herself, and the air bubbles on the fitting surface are naturally discharged through the micropores and grooves on the surface of the cushion. The acoustic impedance of the cushion is at the same level as that of the human body, so the ultrasonic waves emitted from the ultrasonic probe are projected into the body tissue with a minimum of artifacts.

[0024] The ultrasonic waves propagating in the body tissue are reflected at the sites where the acoustic impedance changes. The reflected waves are received by multiple probes including the emitting source probe. Based on the ultrasonic waves reflected at angles significantly different from the projection angle, the acoustic radiation pressure and the propagation speed of the shear wave are measured, and the hardness and composition of the structures in the body tissue are estimated. The reflection, reception, and attenuation of the ultrasonic waves emitted from each ultrasonic probe progress, and the differences in time and space are managed in milliseconds and millimeters so as not to interfere with the ultrasonic waves to be emitted next. The ultrasonic waves are transmitted and received from each ultrasonic probe at a high refresh rate to capture the morphology and its changes in the body tissue.

[0025] By ensuring a sufficiently high refresh rate and a projection range covering the area of interest, the movement of the body tissue (gallbladder contraction, gastrointestinal peristalsis, uterine contraction) that changes in units of several seconds to dozens of seconds is captured.

[0026] By utilizing the Doppler effect and measuring with a reduced area of interest, the blood flow dynamics, fetal heart rate, and their instantaneous changes that occur in a shorter time are also captured.

[0027] The signals obtained from multiple ultrasonic probes are sent into the main body or transmitted to an external arithmetic processing device through communication, and are integrated into a three-dimensional structure model by an algorithm or artificial intelligence that has completed learning.

[0028] The mutual positions and angles of each ultrasonic probe are estimated by the flexion and extension sensors in the cushion. In addition, a three-dimensional structure model of the area of interest is constructed by superimposing, smoothing, and interpolating the common parts in the reflection images collected by adjacent ultrasonic probes.

[0029] The algorithm or artificial intelligence for constructing the three-dimensional structure model is designed to learn the optimal parameters based on the accumulated data, and the performance will not be reduced even with fewer input signals and computing resources. It is operated considering the balance of noise robustness, energy-saving performance, and accuracy.

[0030] The morphology, dynamics, hardness, and composition of the three-dimensional structure model are automatically evaluated and displayed on a monitor at the user's hand, a computer used by a remote information sharer, or a system in the cloud. For example, the estimated weight of a child can be measured based on the biparietal diameter, abdominal circumference, and femur length of the fetal head, and the health status can also be measured based on respiratory-like movements, heart rate, movements of the limbs and trunk, and amniotic fluid volume. The evaluation value uses a calculation formula based on common medical knowledge, but is not limited thereto, and the evaluation value can also be obtained by machine learning with the obtained three-dimensional structure model as an explanatory variable and evaluation values such as health status and estimated weight as target variables.

[0031] When an outlier is confirmed in the evaluation of the three-dimensional structure model, the situation of the existence of the outlier is communicated to a monitor at the user's hand, a computer used by a remote information sharer, or a system in the cloud.

[0032] Advantages of the Invention

[0033] The system of the present invention does not require an operator, so it can perform examinations regardless of the limitations of the accessible range of doctors and medical technicians, which have been pointed out to be in chronic shortage. Since there is no need to pay the labor cost of medical workers with a high hourly rate, the examination cost is reduced, which is effective for the popularization of screening examinations and the early detection of diseases. Without going through manual operations, quantitative collection and comparison of examination results can be performed, and it is easy to conduct research based on big data that aggregates examination results obtained at multiple facilities. In addition, by reducing the workload required for examinations in labor-intensive medical fields, the time allocated to other operations such as treatment and patient explanation can also be increased. In addition, it also has the advantages of shortening the waiting time of examinees in outpatient clinics and wards and correcting regional differences caused by the amount of medical resources.

[0034] [Brief Description of the Drawings]

[0035] Figure 1 It is a block diagram constituting an embodiment of the present invention.

[0036] Figure 2 It is an explanatory diagram showing a method of winding a main body around body tissue and performing an examination.

[0037] Figure 3 It is a configuration explanatory diagram of a pad, a plurality of probes, a flexion sensor and an extension sensor, an arithmetic processing device, a wireless or wired power supply device, and a wireless or wired information communication device that constitute the main body.

[0038] Figure 4 It is a flowchart of an ultrasonic diagnosis method as an embodiment of the present invention.

[0039] Figure 5It is an explanatory diagram for integrating multiple signals by an arithmetic processing device in a main body or in the cloud and constructing a three-dimensional structure model of a region of interest. [Detailed Implementation Manner]

[0040] (Structure of Ultrasonic Diagnostic System)

[0041] Figure 1 It is a block diagram showing the overall structure of the ultrasonic diagnostic system that is optimal in the implementation of the present invention. The main body (ultrasonic diagnostic device) is installed without being restricted by the location, from a medical institution to the patient's own home. The region of interest in this embodiment is the upper abdomen, and a three-dimensional structure model of the liver is illustrated. In addition, in the present invention, the ultrasonic diagnostic system constructs a three-dimensional structure model of the liver, but is not limited thereto, and may also be configured to obtain a three-dimensional structure model of a fetus, and three-dimensional structure models of organs other than the liver or soft tissues such as the thyroid gland and muscle mass of the extremities. In this case, instead of the upper abdomen, the part where the fetus or an organ other than the liver, the neck, or the extremities can be observed is used as the region of interest to wear the ultrasonic diagnostic device described later.

[0042] In Figure 1 this, the ultrasonic diagnostic system of this embodiment includes an ultrasonic diagnostic device and an information terminal device. The ultrasonic diagnostic device includes a mat 2, an ultrasonic probe 3, a flexion / extension sensor 7, an arithmetic processing device 4, a power supply device 6, and a communication device 5. The signals sent from the ultrasonic probe 3 or the three-dimensional structure model defined by the arithmetic processing device 4 (a general-purpose computer or a system in the cloud) are evaluated for shape and dynamics by the arithmetic processing device 4, and are sent to the communication device 8 of the information terminal device via wireless communication or wired communication, and are displayed on the display (output interface) at the user's hand of the information terminal device or to a remote sharer.

[0043] Figure 2 It is a diagram of a subject in the supine position wearing the mat 2 on the abdomen by himself / herself. The mat 2 has a horizontal width of 30 to 40 cm and a vertical width of about 20 to 30 cm. In order not to burden the subject, when the weight is a problem, the arithmetic processing device 4 or the power supply device 6 can be separated from the main body. In Figure 2 this, the power supply device 6 and the communication device 5 are integrally formed with the arithmetic processing device 4 and are connected to the ultrasonic probe 3 provided (preferably built-in) in the mat 2 via a wire. In order not to interfere with the transmission and reception of ultrasonic waves, a fine structure process is performed on the bonding surface between the mat 2 and the surface of the body tissue 1 so that air bubbles do not generate or are naturally squeezed out. In the case where it is impossible to avoid unevenness due to body hair, scars, or protrusions on the skin, a commercially available coupling agent having the same acoustic impedance as that of the human body is additionally applied.

[0044] In Figure 2In this case, the subject is in the supine position, but by fixing the main body to the back or shoulders with a strap, examination can be performed in the standing position, sitting position, or while walking. Thus, it is possible to examine how the organs and fetus in the region of interest are affected by gravity and the movement of the subject's body position.

[0045] Figure 3 This is an example showing the arrangement and connection of the respective components constituting the main body. The cushion 2 is softly deformed to match the body tissue 1 that is the object, and projects ultrasonic waves in a manner that surrounds the region of interest. In order to estimate the relative positions and angles of the ultrasonic probes 3, flexion / extension sensors 7 are provided inside the cushion 1.

[0046] Regarding the setting position of the ultrasonic probes 3, from the viewpoint of efficiently acquiring a partial region of the human body with ultrasonic waves that expand in a substantially conical shape, the ultrasonic probes 3 are preferably arranged in a planar grid structure or a hexagonal close-packed structure. For example, the ultrasonic probes 3 preferably form a grid structure or a honeycomb structure with an angle of approximately 60 degrees or approximately 90 degrees with respect to each other, and the ultrasonic probes 3 are arranged at a portion corresponding to the center point of the grid structure or the honeycomb structure.

[0047] In addition, the angle at which the ultrasonic waves expand in a substantially conical shape is determined by the shape of the conical portion of the ultrasonic probe 3. Therefore, depending on the shape of the conical portion, it is preferable to form an angle of 30° to 120° with respect to each other. Furthermore, from the viewpoint of improving the measurement accuracy, it is preferable to integrate at least two piezoelectric elements in the ultrasonic probe 3.

[0048] The plurality of ultrasonic probes 3 can be arranged on the basis of the optimal arrangement calculated by the ultrasonic diagnostic apparatus. For example, the plurality of ultrasonic probes 3 can be arranged on the basis of estimating the arrangement of the plurality of ultrasonic probes 3 by methods such as maximizing the number of ultrasonic probes 3 that include an arbitrary curved surface within the irradiation range in the diagnostic object tissue. Thus, it is possible to calculate an arrangement that improves the resolution of the three-dimensional model under the constraint of the upper limit number of the plurality of ultrasonic probes 3, and to improve the resolution of the three-dimensional model as much as possible.

[0049] The flexion / extension sensors 7 are preferably arranged in a layer that is deeper or at the same depth as the ultrasonic probes 3 when viewed from the surface of the body tissue 1 to connect the respective ultrasonic probes 3. For example, as Figure 3 shown, when the ultrasonic probes 3 are arranged at the center point of the grid structure with an angle of approximately 90 degrees with respect to each other, the flexion / extension sensors 7 are preferably arranged at the midpoint of each center point of the honeycomb structure. In addition, other than this, the flexion / extension sensors 7 can also be laid out in a grid pattern completely independently of the arrangement of the ultrasonic probes 3. In this case, in order to suppress interference with the position of the ultrasonic probes 3, the flexion / extension sensors 7 preferably enter a layer that is shallower than the ultrasonic probes 3.

[0050] In addition, the configuration and integration density of the ultrasonic probe 3 vary according to the inspection purpose and the required accuracy. In the case where a high spatial resolution is desired, a device with a high integration density is used, and in the case where the purpose is to measure the large-scale movement and size of the structure within the region of interest, a device with a low integration density is used. Thereby, a balance between the required performance and cost is achieved.

[0051] In addition, the configuration method, performance, etc. of the ultrasonic probe 3 and the flexion / extension sensor 7 can also be determined by simulation within the target range.

[0052] The arithmetic processing device 4 and the communication device 5 can be built-in or detachable according to the purpose. When the purpose is measurement during short time and movement, weight reduction and energy saving are achieved by detaching the heavy components. The power supply is also carried out by a detachable built-in battery or wired.

[0053] (Ultrasonic diagnosis method)

[0054] Next, the ultrasonic diagnosis method performed by the ultrasonic diagnosis system of the present invention will be described.

[0055] Each of the plurality of ultrasonic probes 3 includes an output unit 31 that generates ultrasonic waves and an input unit 32 that acquires ultrasonic waves. Here, as the ultrasonic waves generated by the output unit 31, pulse waves are preferably used. The frequency of the pulse wave 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 wavelength is preferably 1 to 15.

[0056] The plurality of ultrasonic probes 3 can each generate ultrasonic waves of the same form, but in the input unit, in order to identify each of the plurality of ultrasonic probes 3, ultrasonic waves of different forms can also be generated respectively. In addition, even in the case where ultrasonic waves of the same form are generated, by setting a predetermined time interval (for example, 50 microseconds to 10 milliseconds, more preferably 100 microseconds to 400 microseconds), the ultrasonic probes 3 can generate ultrasonic waves respectively, so as to identify each of the plurality of ultrasonic probes 3.

[0057] A part of the ultrasonic waves (input waves) generated by the output unit 31 forms a reflected wave when reflected on the surface of the diagnostic object tissue when reaching the diagnostic object tissue. In addition, another part of the input wave diffuses on the surface of the diagnostic object tissue to form a diffused wave. And another part of the input wave is transmitted through the body as a transmitted wave without reflection and diffusion. In addition, the input wave refracts due to density changes in the body tissue and forms 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 arithmetic processing device 4 discriminates at least one of the reflected wave, diffused wave, transmitted wave, and refracted wave.

[0058] 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, the input wave emitted from the output unit 31 of one ultrasonic probe 3 is reflected at the target point, and the input unit 32 of another ultrasonic probe 3 (or one ultrasonic probe 3 when the direction of the input wave is parallel to the direction of the normal of the target point) detects the reflected wave, thereby estimating the position vector t from the output unit 31 of one ultrasonic probe 3 to the specific target point on the surface of the tissue to be diagnosed. → ("● → " is the vector mark of "●") and the unit normal vector n of the target point → . Among them, the position vector t → satisfies the following formula (1), and the unit normal vector n → satisfies the following formula (2).

[0059] p → = t → + r → ......(1).

[0060] n → = s → + r → ......(2).

[0061] Among them, "p → " is the position vector from the output unit 31 of one ultrasonic probe 3 to the input unit 32 of another ultrasonic probe 3. The other ultrasonic probe 3 mentioned here is the ultrasonic probe 3 that detects the reflected wave in the input wave, so it is the ultrasonic probe 3 that observes the ultrasonic wave with the maximum intensity among multiple ultrasonic probes 3. "r → " is the unit vector of the reflected wave reaching the input unit 32 of the other ultrasonic probe 3. "s → " is the unit vector of the input wave emitted from the output unit 31 of one ultrasonic probe 3. In addition, formula (1) can be deformed as the following formula (3).

[0062] p → = t → + r → = l t s → + l r r → ......(3).

[0063] Among them, "l t " is the magnitude of the position vector t → (that is, the distance from one ultrasonic probe 3 to the target point). In addition, "l r " is the magnitude of the position vector r → (that is, the distance from the other ultrasonic probe 3 to the target point). And the input wave unit vector s →and the unit vector r of the reflected wave → Satisfy the following formula (4), so the unit vector s of the input wave can be obtained → and the unit vector n of the normal → The formed angle θ.

[0064] s → ·r → =cos2θ……(4).

[0065] ("·" represents the inner product operation of vectors.)

[0066] In addition, regarding the distance l t and the distance l r , the following formula (5) holds.

[0067] l t +l r =cT……(5).

[0068] Among them, "c" is the sound speed of ultrasonic waves in the body. Although it also depends on the vibration number and tissue, it is usually 1400 - 1600 m / sec. In addition, the sound speed of some tissues such as bone is calculated to be 3500 - 4500 m / sec. "T" is the time from when the input wave is emitted from the output part 31 of one ultrasonic probe 3 until the reflected wave is detected by the input part 32 of another ultrasonic probe 3.

[0069] Through the above-described formulas (1) - (5), based on the known sound speed c, time T, unit vector s of the input wave → , unit vector r of the reflected wave → and position vector p → , the position vector t → and the unit vector n of the normal of the target point can be estimated. → .

[0070] In addition, according to the difference in acoustic impedance between the organ or fetus and the body tissue around the organ or fetus, the reflected wave undergoes fixed-end reflection or free-end reflection. On the basis of considering the fixed-end reflection or free-end reflection, by considering the phase change of the pulse wave, it is possible to distinguish from the refracted wave described later.

[0071] Diffusion waves are used to estimate in detail the position and normal of a specific target point on the surface of the diagnostic object tissue in a plane assuming Lambertian reflection. In a plane assuming Lambertian reflection, a part of the input wave is diffused through Lambertian reflection that spreads uniformly in a hemispherical shape. Here, it is known that the reflectance of Lambertian reflection satisfies the following formula (6).

[0072] i = ρn → ·s → ……(6).

[0073] Here, "i" is the Lambert diffuse reflectance, and "ρ" is a proportionality constant determined according to the material of the object. In this way, the Lambert diffuse reflectance i depends on the unit vector s of the input wave → and the unit vector n of the normal → . Therefore, by making the Lambert diffuse reflectance constant according to the unit vectors s of the input waves with different vectors generated in the plurality of ultrasonic probes 3 → , the unit vector n of the normal can be estimated → . In addition, the roughness of the target point can also be estimated based on the Lambert diffuse reflectance at the target point.

[0074] The transmitted wave and the refracted wave are used together to estimate the acoustic impedance (density distribution) inside the body tissue. The input wave generated in the output unit 31 of the ultrasonic probe 3 is sometimes refracted according to the acoustic impedance difference in the body tissue. And, a part of the input wave sometimes transmits without being refracted, reflected, or diffused. The relative angle (the angle θ formed by the unit vector s of the input wave → and the unit vector n of the normal → ) and the distance (the magnitude of the position vector p → ) between one ultrasonic probe 3 (the ultrasonic probe 3 that generates the input wave) and another ultrasonic probe 3 (the ultrasonic probe on the receiving side) can be obtained by the above method, thereby obtaining information on the refraction or straight-line propagation of the input wave. The time required for the input wave to propagate between the ultrasonic probes 3 can be obtained from the actual data. The sound velocity on the path can be calculated based on the distance between one ultrasonic probe 3 and another ultrasonic probe 3 and the propagation time. Since the sound velocity depends on the density of the object for propagation, the average density of the object on the path can be estimated. By calculating the average density on this path between the plurality of ultrasonic probes 3, the density distribution of any region inside the body tissue can be calculated.

[0075] Next, a method for generating a three-dimensional model of the tissue to be diagnosed by the ultrasonic diagnostic system of the present invention and a method for estimating the quality of the three-dimensional model will be described.

[0076] Figure 4 is a flowchart showing the method for generating a three-dimensional model of the present invention and the method for estimating the quality of the generated three-dimensional model. First, through the turning on of the power supply of the ultrasonic diagnostic device, etc., the diagnostic method of the ultrasonic diagnostic device is started ( Figure 4 / Start).

[0077] Next, it is determined whether the ultrasonic diagnostic device is correctly worn ( Figure 4 / Step 1). This determination is made by using an automatic determination of the signal-to-noise ratio, an automatic determination of the curvature of the ultrasonic diagnostic device calculated by a plurality of flexion / extension sensors 7 (for example, the curvature of a pregnant abdomen that may exist clinically is in the range of R = 150 mm to 400 mm), an automatic determination of detecting a local flexion degree significantly deviating from a spherical surface or a flexion degree in the opposite direction, an automatic determination of surface / back detection using a spirit level (not shown), an automatic determination of head / tail detection based on the fact that the upper edge of the pubis is thicker than the lower end of the sternum, etc. In addition, Step 1 can be performed on the basis of a manual judgment, or Step 1 itself can be omitted.

[0078] In the case where this determination is negative ( Figure 4 / Step 1... No), the ultrasonic diagnostic device is controlled to return to the previous operation, and Step 1 is executed again. In addition, at this time, a notification such as generating an accurate position can be made through a notification device or the like. On the other hand, in the case where this process is positive ( Figure 4 / Step 1... Yes), the identifier i is substituted with 1 ( Figure 4 / Step 2).

[0079] Next, a specific input wave is generated in the i-th ultrasonic probe 3 among the plurality of ultrasonic probes 3 ( Figure 4 / Step 3). As described above, the input wave is preferably a specific pulse wave, and its frequency, amplitude, phase, waveform, etc. can also be changed according to i. In addition, the pulse wave can be constituted by a combination of a plurality of sine waves, and i-dependence can be given to the frequency, wave number, etc. when performing Fourier transform on the pulse wave. Furthermore, from the viewpoint of ensuring the reliability of data, the input wave can be generated multiple times. In this case, each input wave can be different or the same according to the number of times.

[0080] In addition, the arrangement and identification numbers of the plurality of ultrasonic probes 3 can be determined according to the arrangement of the ultrasonic probes 3. That is, the ultrasonic probe 3 existing in the first row and the first column among the plurality of ultrasonic probes 3 arranged in a grid can be determined as the first ultrasonic probe, and the ultrasonic probe 3 existing in the j-th row and the k-th column can be determined as the (ΣJ k-1 +k)-th ultrasonic probe 3 (J k-1 is the total number constituting k - 1 columns). In addition, for example, the ultrasonic probe 3 existing in the center can also be used as the first ultrasonic probe, and the identification numbers can be marked in a spiral shape.

[0081] In addition, it can also be that, on the basis of determining the ultrasonic probe 3 in the first row and the first column as the first ultrasonic probe, the ultrasonic probe farthest from the first ultrasonic probe 3 is determined as the second ultrasonic probe 3. That is, the ultrasonic probe 3 that is farthest from the i-th ultrasonic probe 3 and is outside the first ultrasonic probe 3 to the (i - 1)-th ultrasonic probe 3 can also be determined 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. Therefore, on the basis of reducing noise, the (i + 1)-th ultrasonic probe can generate an input wave. And, since the input wave of the i-th ultrasonic probe 3 weakens near the (i + 1)-th ultrasonic probe, the ultrasonic probe switching conditions described later are quickly satisfied, and the ultrasonic diagnosis time is also shortened.

[0082] Alternatively, it can also be that the distance between the i-th ultrasonic probe and the (i + 1)-th ultrasonic probe is set as D i , and it is accumulated until i + 1 reaches N, and an arbitrary identification number is marked so that (ΣD i )(i = 1 to N - 1) becomes the maximum. In addition, at this time, it is preferably marked with an identification number on the basis of considering whether there is a situation where interference waves and multiple reflections are likely to remain due to the relative angle (the angle θ formed by the input wave unit vector s → and the normal unit vector n → ) between the i-th ultrasonic probe and the (i + 1)-th ultrasonic probe. In this case, on the basis of reducing the influence of interference waves or multiple reflection waves of the input wave output from the i-th ultrasonic probe, an input wave can be output from the (i + 1)-th ultrasonic probe. And by controlling the irradiation order with such an identification number, the time efficiency of ultrasonic diagnosis can be improved.

[0083] In addition to the above-described method of marking the identification number, the identification number can also be marked randomly in space, or can be concentrated and marked on a part in a biased manner according to the object of investigation.

[0084] After the input wave is generated, it is input to a plurality of ultrasonic probes 3 as a reflected wave, a diffused wave, a transmitted wave, or a refracted wave. At this time, the reflected wave, the diffused wave, the transmitted wave, or the refracted wave is stored in a storage unit (not shown) as a parameter for generating a three-dimensional model or a three-dimensional density distribution described later. Then, it is determined whether the ultrasonic probe switching condition ( Figure 4 / Step 4) is satisfied.

[0085] Here, the "ultrasonic probe switching condition" refers to the condition under which the ultrasonic probe 3 that generates the input wave switches from the i-th ultrasonic probe 3 to the (i + 1)-th ultrasonic probe 3. The ultrasonic probe switching condition is, for example, a condition satisfied when a certain amount of time has elapsed after the i-th ultrasonic probe 3 generates the input wave. Additionally, the ultrasonic probe switching condition can be determined based on, for example, the arrival of the ultrasonic wave at the receiving probe including the i-th ultrasonic probe.

[0086] Next, substitute i + 1 for the identifier i ( Figure 4 / Step 5), and determine whether the current identifier i is N ( Figure 4 / Step 6). "N" is preferably the total number of ultrasonic probes 3 built into the ultrasonic diagnostic device, but it can also be the minimum number of data collection times capable of obtaining sufficient ultrasonic probe data based on generating a three-dimensional model or three-dimensional density distribution. That is, "N" can also be less than the total number of ultrasonic probes 3 built into the ultrasonic diagnostic device.

[0087] In the case where the determination is negative ( Figure 4 / Step 6... No), return to before Step 3 and execute the processing after Step 3 again. On the other hand, in the case where this processing is affirmative ( Figure 4 / Step 6... Yes), execute the processing after Step 7.

[0088] In Step 7, the ultrasonic diagnostic device generates a three-dimensional model of the diagnostic object tissue ( Figure 4 / Step 7). Specifically, based on determining that at least one of the information obtained in Steps 3 to 4 is a reflected wave, a diffused wave, a transmitted wave, or a refracted wave, at least one of the information of the positions of multiple target points in the actual coordinates, the normal unit vectors of multiple target points, the roughness of multiple target points, and the density of multiple target points is obtained. Based on this, a three-dimensional model of the diagnostic object tissue is generated according to at least one of the information of the positions of multiple target points in the actual coordinates, the normal unit vectors of multiple target points, the roughness of multiple target points, and the density of multiple target points.

[0089] Alternatively, it can be omitted, but it can also be generated, before, after, or in parallel with Step 7, a three-dimensional density distribution of the diagnostic object tissue according to at least one of the information of the positions of multiple target points in the actual coordinates, the normal unit vectors of multiple target points, the roughness of multiple target points, and the density of multiple target points ( Figure 4 / Step 8).

[0090] Next, calculate the quality of the three-dimensional model ( Figure 4 / Step 9), and the ultrasonic diagnostic method of the present invention ends ( Figure 4 / End). The quality of the three-dimensional model can be calculated in the following ways: Integrate the density of each target point over a small volume based on the three-dimensional model and the three-dimensional density distribution, but not limited to this. For example, it can also be calculated using the formula in the paper or statistical data, etc., based on an arbitrary cross-sectional area of the three-dimensional model. For example, the volume, shape, or quality of the tissue to be diagnosed can be estimated based on at least one of the major axis, minor axis, cross-sectional area, perimeter diameter, curvature, and distance of an arbitrary cross-section of the three-dimensional model. For example, in the case of a fetus, it can be calculated by using the following formula (7), which is the recommended formula of the Japan Society of Ultrasonics in Medicine, or the formula of Shinozuka.

[0091] Estimated fetal weight (g) = 1.07 × Biparietal diameter of fetal head (cm) 3

[0092] + 0.30 × Abdominal circumference (cm) 2 × Femur length (cm)

[0093] ……(7).

[0094] That is, it can be that the biparietal diameter of the fetal head, abdominal circumference, and femur length are automatically measured based on the three-dimensional model, and the quality is thus obtained. In addition, the following machine learning or deep learning, etc., can also be used: Use at least one of the information of the positions of multiple target points at actual coordinates, the normal unit vectors of multiple target points, the roughness of multiple target points, and the density of multiple target points as explanatory variables, and use at least one of the three-dimensional model of the tissue to be diagnosed, the three-dimensional density distribution, and the quality of the tissue to be diagnosed as the target variable.

[0095] In addition, although not shown, the processing of the above steps 1 to 9 can be repeated 0.2 times to 64 times within 1 second, preferably 2 times to 16 times, thereby capturing the temporal changes in the surface shape and quality of the three-dimensional model of the tissue to be diagnosed and estimating the dynamics. It can also be configured to compare the morphology (volume, shape, quality) and dynamics (temporal changes in volume, shape, quality) of the tissue to be diagnosed with clinical standards or diagnostic benchmarks, so as to perform normal determination, abnormal determination, or even determination of the degree of abnormality.

[0096] Figure 5 Show the three-dimensional structure model of the liver in the region of interest estimated by the above method and the set of ultrasonic reflection images from multiple directions used to construct the three-dimensional structure model. In this embodiment, evaluations such as the morphology of the liver, the course of the vascular system such as the hepatic artery, hepatic vein, and portal vein and blood flow dynamics, the contraction of the gallbladder, the degree of hardness and fibrosis of the liver tissue, fat deposition based on the liver-kidney contrast, and the mobility and adhesion of the liver based on respiration or body position movement are performed.

[0097] Each evaluation item is represented by general terms and indicators that can be understood by non-medical users. On the other hand, more professional terms and indicators are provided to medical workers for information sharing.

[0098] Data from the consenting examinees is stored in the built-in memory or in the cloud for the optimization of algorithms or artificial intelligence for constructing three-dimensional structure models.

[0099] As described above, the automatic inspection method, device, and program using the ultrasonic probe 3 of the present invention have been described based on the embodiments. However, the present invention can be used within the scope of the object of the present invention and within the technical scope thereof, in addition to the above-described embodiments. In addition, for those skilled in the art, the embodiments and usage examples of the present invention can be deformed and changed within a range that can be easily deformed and changed.

[0100] Industrial applicability

[0101] The automatic inspection method, device, and program using the ultrasonic probe 3 arranged on a plane according to the present invention do not require an operator other than the examinee. Therefore, the inspection can be performed regardless of the presence or absence of medical institutions and medical workers, and the evaluation of body tissues can be performed quickly and automatically. Therefore, the following industrial applications can be expected.

[0102] In areas with scarce medical resources such as isolated islands and remote areas, and even in urban areas during periods of supply falling short due to epidemics, disasters, etc., and in departments such as emergency departments, obstetrics and gynecology departments, surgical departments, internal medicine departments, pediatrics departments, and home medical care where the number of medical workers corresponding to the number of patients is insufficient, it can be used for screening for diseases and disabilities and determining the severity of illness, contributing to efficient human resource investment.

[0103] For the examinee, different from the examinations in outpatient clinics and wards, the examination can be completed by oneself. Therefore, it is possible to reduce the risk of exposure to infectious diseases caused by reduced contact opportunities and to perform rapid examinations without waiting.

[0104] By preparing bodies of various sizes, examinations can be performed on the neck, limbs, abdominal organs, pelvic organs, pregnant abdomen and fetus, and fetal appendages. By evaluating the movement, stenosis, thrombosis, and blood flow disorders of arteries and veins, information suitable for the prevention of infarction and the formulation of rehabilitation can be provided. By evaluating the peristalsis of the lower digestive tract and the composition of intestinal contents, intestinal obstruction can be prevented and defecation control can be improved. In the examination of the thyroid gland in the neck, the size, shape, and composition can be evaluated together, so that the speed of examination can be increased and the manpower requirement can be reduced.

[0105] In the pregnant abdomen, the fetal reserve function can be estimated by evaluating the fetal breathing-like movements, movements of the limbs and trunk, heart rate, and amniotic fluid volume in the uterus. In addition, the intensity of uterine contractions can be inferred from the dynamics of the entire uterus, enabling the acquisition of more detailed and real-time clinical information than the cardiotocogram widely used in pregnancy and delivery management.

[0106] As described above, it is possible to detect the onset of fetal cerebral palsy and perinatal death, which develop in units of several minutes to several tens of minutes from the onset, and issue an alarm. Early detection is related to early intervention and helps improve the perinatal prognosis.

[0107] This system does not require an operator other than the subject, and the main body conforms to the body tissue. Therefore, the posture of the subject is not limited to the supine position adopted in normal examinations, and examinations can be performed in the standing position, sitting position, or while walking.

[0108] The dynamic images, three-dimensional structure models, and evaluation values obtained by this system are quantitative compared to manual examinations, enabling research and education based on cumulative data.

[0109] The dynamic images, three-dimensional structure models, and evaluation values obtained by this system can be shared on social networking services, etc., according to the wishes of the user.

[0110] By using electromagnetic waves as the signals in this system and targeting mechanical structures and buildings, it can also be applied to the internal structure confirmation of easily transportable machinery and buildings.

[0111] Symbol Explanation

[0112] 1: Body tissue; 2: Pad; 3: Ultrasonic probe; 4: Arithmetic processing device; 5: Communication device (ultrasonic diagnostic device); 6: Power supply device; 7: Flexion / extension sensor; 8: Communication device (information terminal device).

Claims

1. An ultrasonic diagnostic device, characterized in that: have: soft cushions; and At least one ultrasound probe is disposed planarly within the mat.

2. The ultrasonic diagnostic apparatus according to claim 1, wherein: The pad has ultrasonic wave transmittance, The pad is provided with a discharge portion for discharging bubbles generated on the surface in contact with the body tissue surface.

3. The ultrasonic diagnostic apparatus according to claim 1, wherein: The pad is provided with a fixing portion fixed to at least a portion of the surface of body tissue.

4. The ultrasonic diagnostic apparatus according to claim 1, wherein: The ultrasonic probe is arranged on the mat.

5. The ultrasonic diagnostic apparatus according to claim 1, wherein: The ultrasonic probe transmits and receives ultrasonic waves according to a fixed frequency and phase.

6. The ultrasonic diagnostic apparatus according to claim 1, characterized in that: The ultrasonic probe sends and receives ultrasonic waves at the best time and position.

7. The ultrasonic diagnostic apparatus according to claim 1, characterized in that: The optimal configuration of the ultrasound probe is calculated.

8. The ultrasonic diagnostic apparatus according to claim 1, wherein: have: A processing device is provided for constructing a three-dimensional structural model based on the parameters acquired by the ultrasonic probe.

9. The ultrasonic diagnostic apparatus according to claim 1, wherein: have: A flexion sensor determines the position of the ultrasound probe.

10. A shape estimation device for estimating the shape of a three-dimensional structure, characterized in that: have: a conformable member that conforms to a tissue surface of a subject; and At least one signal transceiver is disposed on the plane of the conformable component.

11. The shape estimation device according to claim 10, characterized in that: have: A calculation processing unit constructs a three-dimensional structural model based on the parameters obtained by the signal transceiver.

12. The shape estimation device according to claim 11, characterized in that: The calculation processing unit constructs a three-dimensional structure model through machine learning based on the parameters.

13. The shape estimation device according to claim 11, characterized in that: The calculation processing unit recognizes at least one of the form, dynamics, and composition of the entire or a part of the three-dimensional structure model.

14. A system comprising the shape estimating device according to any one of claims 10 to 13 and an information terminal device, wherein: The system transmits the three-dimensional structure model determined by the shape estimating device to the information terminal device.

15. The system according to claim 14, characterized in that have: anomaly detection means for detecting anomalies of the three-dimensional structural model, The abnormality detected by the abnormality detection device is transmitted to either the information terminal device or the shape estimation device.

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