Ultrasonic measuring instrument and ultrasonic measuring method

Abstract

Provided are an ultrasonic measurement device and an ultrasonic measurement method capable of reducing the occurrence of errors and measuring a state of a living body with a simpler operation. The ultrasonic measurement device (1) is provided with a probe (10) comprising an array of ultrasonic elements (61a-61d) for transmitting ultrasonic waves toward a structure in a living body, and a measurement part (86) for measuring the state of the structure on the basis of reflected waves from the structure. The probe (1) has a probe head (40), which contacts the living body. The probe head (40) has a first end (45), which is disposed on a head side of the living body when the probe head contacts the living body, and a second end (46), which is disposed on a pubic bone side of the living body. When viewed from the side surface, the probe head has a convex curved surface (C1) that slopes so as to become thinner from the first end (45) to the second end (46). The ultrasonic measurement method of the embodiment comprises a step for transmitting ultrasonic waves from ultrasonic elements, and a step for measuring the state of the structure in the living body on the basis of reflected waves from the structure.

Description

Technical Field

[0001] The present invention relates to an ultrasonic measuring device and an ultrasonic measuring method, and more particularly to an ultrasonic measuring device and an ultrasonic measuring method for measuring the state of structures such as internal organs and tissues in a living body by measurement using ultrasonic waves.

Background Art

[0002] Conventionally, an ultrasonic measuring device that transmits ultrasonic waves toward the inside of a living body such as a human body and receives an ultrasonic echo that is the reflected wave thereof to measure the state of structures such as internal organs and diseased tissues in the living body is known. For example, the ultrasonic measuring device can also be used as a urine volume measuring device that measures the size of the bladder to measure the amount of urine stored in the bladder.

[0003] Many people have a symptom in which they cannot feel that urine has accumulated in the bladder (no urge to urinate) due to diseases or injuries of the nerves and brain that control the urinary regulation mechanism. If such people can easily use an ultrasonic measuring device at home, their quality of life can be improved. Against this background, an ultrasonic measuring device with high portability and easy positioning has been proposed in Patent Document 1. In this ultrasonic measuring device, by acquiring one-dimensional information using the ultrasonic A mode, the urine volume can be measured while grasping the angle of the probe.

[0004] In ultrasound mode A, the ultrasound measuring device is typically moved to determine a suitable position for measurement by measuring the amount of urine stored. Then, the ultrasound measuring device is moved near a predetermined position on the abdomen to measure the amount of urine stored. For example, Patent Document 1 discloses a method for measuring the amount of urine stored by moving the ultrasound measuring device back and forth along the midline of the body near the bladder while the ultrasound measuring device is pressed vertically against the body. In the forward movement, when the ultrasound measuring device is slid from the pubic bone towards the navel, a scan is performed to find a position where the amount of urine stored is provisionally identified as the maximum. Then, in the return movement, when the ultrasound measuring device is slid in the opposite direction to the navel, towards the pubic bone, the ultrasound measuring device is guided to the position identified in the forward movement, and multiple measurements are taken at that position to measure the amount of urine as the standard deviation of the maximum value. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] International Publication No. 2020 / 100942 [Overview of the project] [Problems that the invention aims to solve]

[0006] As a result of diligent research by the inventors, we discovered the importance of reducing the amount of movement required for the ultrasonic measuring device to measure the condition of internal organs and tissues within the body, which led to the present invention.

[0007] The present invention has been made in view of the conventional problems, and aims to provide an ultrasonic measuring device and ultrasonic measuring method that reduce the occurrence of errors, improve measurement accuracy and reproducibility, allow for measurement of the state of the living body with simpler operation, and further enable urine volume measurement in a seated position. [Means for solving the problem]

[0008] To solve the above problems, the ultrasonic measuring instrument described in the embodiment is A probe having an array of ultrasonic elements that emit ultrasound towards structures within a living organism, A measuring unit that measures the state of the structure based on reflected waves from the structure. An ultrasonic measuring instrument equipped with, The probe has a probe head that contacts a living body, the probe head having a first end positioned on the head side of the living body when in contact with the living body, and a second end positioned on the pubic side of the living body, and the probe head has a convex curved surface that slopes to become thinner from the first end to the second end when viewed from the side.

[0009] Here, the curved surface may include an arc with a predetermined radius of curvature.

[0010] Furthermore, the radius of curvature can be set to 100 mm to 200 mm.

[0011] Furthermore, the inner wall of the probe head on which the arrangement of ultrasonic elements is mounted may be inclined to follow the curved surface.

[0012] Furthermore, the thickness of the inner wall of the probe head in the portion where the array of ultrasonic elements is mounted can be greater than 0 mm and less than 2 mm.

[0013] Furthermore, the ultrasonic measuring device is a urine volume measuring device, and the state of the structure may be the amount of urine in the bladder.

[0014] The ultrasonic measurement method described in the embodiment is an ultrasonic measurement method using an ultrasonic measuring instrument equipped with a probe having an array of ultrasonic elements that emit ultrasonic waves toward a living body, wherein the probe has a probe head that contacts the living body, the probe head has a first end that is positioned on the head side of the living body when in contact with the living body, and a second end that is positioned on the pubic side of the living body, and when the probe head is viewed from the side, it has a convex curved surface that slopes to become thinner from the first end toward the second end. The step of bringing the curved surface into contact with the surface of the living organism such that the curved surface is in contact with the surface of the living organism from the first end to the second end, a step of transmitting ultrasonic waves from the ultrasonic element; a step of measuring the state of the structure based on a reflected wave from the structure in the living body and the method includes.

[0015] Here, the method further includes a step of tilting the ultrasonic measuring device toward the head side with a vicinity of the first end as a fulcrum, wherein the measuring step can measure the state of the structure while the ultrasonic measuring device is tilted.

[0016] The method further includes a step of translating the ultrasonic measuring device in a state where the curved surface is in contact with the surface of the living body, wherein the measuring step measures the state of the structure during the translation of the ultrasonic measuring device, and includes a step of determining a position to start the tilting step on the surface of the living body based on the result of the measurement.

[0017] The method further includes a step of determining an angle of the ultrasonic measuring device when the position is determined in the step of determining the position, wherein the measuring step can correct a value of the state of the structure measured by tilting the ultrasonic measuring device according to the determined angle.

[0018] The ultrasonic measuring device is a urine volume measuring device, the state of the structure is the urine volume in the bladder, and the contacting step can contact the curved surface with the surface of the living body such that the first end is located on the head side of the living body and the second end is located on the pubic side of the living body.

Advantages of the Invention

[0019] According to the present invention, the probe head of the probe has a convex curved surface that slopes from the first end to the second end. Therefore, the curved surface makes it easier for the probe to contact the surface of the living body, and the reproducibility of the measurement can be improved. In addition, by increasing the tilt angle when tilting with one end as a fulcrum, the state of the structure near the surface of the living body can be accurately measured.

[0020] In addition, in order to perform detailed measurements by tilting the ultrasonic measuring device at a determined position, the state of the living body can be measured with a simpler operation. Furthermore, since the amount of movement of the ultrasonic measuring device during measurement is reduced, it becomes possible to measure the state of the living body in a sitting position.

Brief Description of the Drawings

[0021] [Figure 1] It is a figure which shows the external appearance of the ultrasonic measuring device of this embodiment. [Figure 2] It is a figure which shows an example of the use state of an ultrasonic measuring device. [Figure 3] (a) is a view of the inside of the probe head of the probe 10 looking in the negative Z-axis direction of FIG. 2, (b) is a view of the outside of the probe head looking in the positive Z-axis direction, (c) is a cross-sectional view of the probe head taken along IIIc-IIIc, and (d) is a cross-sectional view of the probe head taken along IIId-IIId. [Figure 4] It is a figure which shows in more detail the IIIc-IIIc cross-sectional view of the probe head shown in FIG. 3(c). [Figure 5] It is a figure which shows an example of the IIIc-IIIc cross-sectional view of the probe head which concerns on embodiment different from FIG. 4. [Figure 6] It shows the arrangement of the ultrasonic elements attached to the probe. [Figure 7] It is a figure which shows the direction of the ultrasonic wave which an ultrasonic element transmits and receives. [Figure 8] It is a block diagram which shows the functional configuration of an ultrasonic measuring device. [Figure 9] It is a schematic diagram of the waveform of the reflected wave received by each ultrasonic element. [Figure 10] This is a flowchart showing the processing procedure in an ultrasonic measuring instrument according to one embodiment. [Figure 11] This diagram shows how an ultrasonic measuring instrument is used. [Figure 12] (a) is a diagram showing how to use an ultrasonic measuring instrument, and (b) is a diagram showing an example of an image displayed on the screen. [Figure 13] (a) is a diagram showing how to use an ultrasonic measuring instrument, and (b) is a diagram showing an example of an image displayed on the screen. [Figure 14] This figure shows an example of an image displayed on a screen. [Figure 15] This graph shows the measurement results of urine volume using the ultrasonic measuring instrument described in the example. [Figure 16] This graph shows the measurement results of urine volume using an ultrasonic measuring instrument related to the comparative example. [Figure 17] This graph shows the measurement results of urine volume using the ultrasonic measuring instrument described in the example. [Figure 18] (a) is a graph comparing the average measurement result with the estimated urine volume value, (b) is a graph showing the error rate in the measurement, and (c) is a graph showing the average measurement time. [Figure 19] (a) is a graph comparing the average measurement result with the estimated urine volume, and (b) is a graph showing the average measurement time. [Figure 20] This is a flowchart showing the procedure for the positioning process according to one embodiment. [Figure 21] Figures 4 and 5 show an example of a IIIc-IIIc cross-sectional view of a probe head according to a different embodiment. [Modes for carrying out the invention]

[0022] The embodiments of the present invention will be described in detail below. In the following embodiments, an example is described in which an ultrasonic measuring instrument is used as a urine volume measuring instrument. A urine volume measuring instrument measures the amount of urine in the bladder as a structural state, but the present invention can also be applied to devices that measure the amount of water contained in various structures in the body, such as measuring the amount of bile contained in the gallbladder or the amount of feces in the intestines.

[0023] (First Embodiment) Figure 1 shows the external appearance of the ultrasonic measuring instrument 1 according to this embodiment, and Figure 2 shows an example of the ultrasonic measuring instrument 1 in use. In this embodiment, the ultrasonic measuring instrument 1 has a probe 10 provided at one end of the main body 2, and the main body 2 is further provided with a display 3, a button 4, a speaker 5, and a communication I / F (interface) 6. For the purpose of explanation, in this specification, the side of the main body 2 on which the display 3 is provided is referred to as the "display surface". This ultrasonic measuring instrument 1 can perform measurements in ultrasonic A mode.

[0024] The ultrasonic measuring device 1 of this embodiment is used as a urine volume measuring device. As shown in Figure 2, the main body 2 of the ultrasonic measuring device 1 is held by the user (measurer: the same person as the person being measured or an assistant performing the measurement) so that the display surface faces the face of the person being measured. The ultrasonic measuring device 1 is formed in a roughly rectangular parallelepiped shape, and is used with the tapered probe 10 facing the end (proximal end) that contacts the surface S1 of the lower abdomen of the person being measured. The probe 10 is pressed against the pubic area of ​​the person being measured while they are lying on their back (supine position), perpendicular to the surface S1 of the lower abdomen, or slightly tilted toward the feet (negative Y-axis direction) from perpendicular.

[0025] Urine volume is measured in two modes: a positioning mode in which the probe 10 is moved parallel to itself, and a measurement mode in which the probe 10 is tilted during measurement. In positioning mode, the ultrasound measuring device 1 is moved parallel to itself along the midline of the body near the bladder while the probe 10 is pressed against it, thereby positioning for measurement in measurement mode. During positioning, a scan is performed to identify the position (also called the peak position) where the urine volume is provisionally identified as the maximum value (also called the provisional maximum value). After that, the device switches to measurement mode, and the urine volume is measured again while tilting the end of the ultrasound measuring device 1 opposite the probe (distal end) towards the head (positive Y-axis direction in Figure 2) to determine the maximum value of the urine volume. Note that in measurement mode, the urine volume may be measured without tilting the probe.

[0026] As a result, the ultrasonic measuring device of this embodiment allows for the determination of an appropriate measurement position and subsequent measurement. Furthermore, accurate measurement of urine volume is possible even without specialized knowledge, and it can be easily used by the patient themselves or other users.

[0027] The probe 10 transmits and receives ultrasonic waves and supplies a received signal to the main unit 2 corresponding to the received ultrasonic echo. That is, each ultrasonic element attached to the probe head of the probe 10 emits ultrasonic waves, and each ultrasonic element receives the ultrasonic echo, which is the reflected wave.

[0028] Here, since the bladder is located in the pelvis, it expands in a characteristic manner based on its anatomical structure. The base of the bladder is tightly attached to the tissues of the pelvic floor, and its movement is restricted. MRI measurements have confirmed that bladder expansion due to urine accumulation mainly expands in the Y direction in Figure 2, pushing aside the relatively mobile small intestine. In the ultrasound measuring device 1 according to this embodiment, four ultrasound elements are arranged at regular intervals along this expansion direction.

[0029] Next, the shape of the probe head of the probe 10 will be described with reference to Figures 3 and 4. Figure 3(a) is a view of the inside of the probe head of the probe 10, looking in the negative Z-axis direction of Figure 2. Figure 3(b) is a view of the outside of the probe head, looking in the positive Z-axis direction. Figure 3(c) is a IIIc-IIIc cross-sectional view of the probe head, and Figure 3(d) is a IIId-IIId cross-sectional view of the probe head. Figure 4 shows the IIIc-IIIc cross-sectional view of the probe head shown in Figure 3(c) in more detail. The probe head 40 has a first end 45 that is positioned on the head side when in contact with a living body, and a second end 46 that is positioned on the pubic bone side. The probe head 40 also has a convex curved surface C1 that slopes to become thinner from the first end 45 to the second end 46 when viewed from the side, as shown in Figure 4. Therefore, the probe head 40 is formed asymmetrically with respect to the longitudinal axis L of the ultrasound measuring instrument 1.

[0030] The curved surface C1 may include an arc with a predetermined radius of curvature. In this case, the curved surface C1 can be formed such that the first end 45 contacts the plane S2 when the ultrasonic measuring instrument 1 is brought into contact with the plane S2 such that the longitudinal axis L of the ultrasonic measuring instrument 1 is perpendicular to the plane S2. In this case, the contact point of the curved surface C1 is equal to the point of contact between a circle with a predetermined radius of curvature and the plane S2.

[0031] The radius of curvature of the curved surface C1 is preferably 100 mm to 200 mm. More preferably, when the radius of curvature is 140 mm or a value close to it, the degree to which the curved surface adheres closely to the lower abdominal surface is increased, and the angle is easy to incline, allowing for accurate measurement of urine volume even when the amount of urine collected is small, as will be described later. In the example shown in Figure 4, the width W in the direction from the first end 45 to the second end 46 is 36.6 mm. Furthermore, the curved surface has a radius of curvature of 140 mm over the entire length from the first end 45 to the second end 46. In one embodiment, the corners of the first end 45 and the second end 46 may be rounded. In particular, since the ultrasonic measuring instrument 1 is tilted with the first end 45 as a fulcrum in the measurement mode, as will be described later, it is preferable to round the corners of the first end 45 with a radius of curvature smaller than the predetermined radius of curvature.

[0032] The inner wall of the probe head 40 has recesses 41 to 44 in which an array of four ultrasonic elements is mounted. In the recesses 41 to 44, the surfaces on which the ultrasonic elements are mounted are inclined along the curved surface C1 of the outer wall of the probe head 40. In the example shown in Figure 4, the angle θ between each surface of recesses 41, 42 and 43 and the plane S2 is 41 ,θ 42 and θ 43 These angles are 16°, 12°, and 7°, respectively. The angle between the recess 44 and the plane S2 is 0°. By tilting the inner wall of the probe head 40 along the outer curved surface C1 of the probe 10 in this way, the thickness of the probe head 40 at the mounting portion of each ultrasonic element can be reduced. In addition, the emission angle of each ultrasonic element is appropriately corrected, and ultrasonic waves can be emitted in the direction normal to the curved surface C1.

[0033] The thickness T of the inner wall of the probe head 40 where the array of ultrasonic elements is attached can be greater than 0 mm and less than 2 mm.

[0034] Figure 5 shows another example of a IIIc-IIIc cross-sectional view of the probe head. The width W of the probe head 50 in the direction from the first end 45 to the second end 46 is 36.6 mm, and the radius of curvature of the curved surface C2 is 100 mm. The angle θ between each surface of the recesses 51, 52, and 53 in which the array of ultrasonic elements is mounted and the plane S2. 51 ,θ 52 and θ 53 These angles are 14°, 10°, and 6°, respectively. The angle between the surface of the recess 54 and the plane S2 is 0°.

[0035] Figure 6 shows the arrangement of ultrasonic elements attached to the probe 10. Head 4 The probe 10 is equipped with multiple (four in Figure 6) ultrasonic elements 61a to 61d arranged in a straight line. The four ultrasonic elements correspond to different probe channels ch1, ch2, ch3, and ch4. When the probe 10 is brought into contact with the lower abdominal surface S1, ultrasonic element 61a is positioned towards the pubic bone and ultrasonic element 61d is positioned towards the head. Figure 7 shows the direction of ultrasound transmitted and received by the ultrasonic elements. In Figure 7, P represents the pubic bone and B represents the bladder. The subject's head is positioned in the positive Y-axis direction. As described above, the inner wall of the probe head 40 is inclined along the outer curved surface C1 of the probe 10, so the ultrasonic elements 61a to 61d are generally arranged along the curved surface C1. In the example shown in Figure 7, the ultrasound emitted from the ultrasound element 61d is transmitted parallel to the axis L, while the ultrasound emitted from the ultrasound elements 16a to 61c is transmitted at an angle to the axis L. As a result, the entire probe emits ultrasound in a fan shape that spreads toward the bladder B.

[0036] Next, with reference to Figure 8, the functional configuration of the ultrasonic measuring instrument 1 will be explained. The ultrasonic measuring instrument 1 mainly consists of a probe 10 and a control unit 80. The control unit 80 includes an ultrasonic control unit 81, an analog-to-digital (A / D) conversion unit 82, an input control unit 83, a gyro sensor 84, a storage unit 85, a measurement unit 86, an audio processing unit 87, a display processing unit 88, and a communication processing unit 89. The ultrasonic control unit 81 controls the transmission and reception of ultrasonic waves and their reflected waves by ultrasonic elements 61a to 61d. The A / D conversion unit 82 converts the reflected ultrasonic waves, which are analog signals, into digital signals. The input control unit 83 receives input data in response to the user's operation of button 4. The gyro sensor 84 detects changes in the angle of the ultrasonic measuring instrument 1 as angular velocity and outputs it as an electrical signal. The storage unit 85 stores various data such as the value of the urine volume and the coefficients of the calculation formula for the urine volume. The measurement unit 86 performs various calculations related to the urine volume based on the digitally converted reflected wave data and other various data. The audio processing unit 87 outputs sound from the speaker 5 based on the calculation data calculated by the measurement unit 86. The display processing unit 88 displays an image on the display 3 based on the calculation data. The communication processing unit 89 communicates with external devices via the communication interface 6.

[0037] The ultrasonic control unit 81 performs transmission control to emit ultrasonic waves from the ultrasonic elements 61a to 61d at predetermined intervals, as well as reception control to amplify the reflected waves received by the ultrasonic elements 61a to 61d. These reflected waves are converted into digital signals by the A / D conversion unit 82 and then input to the measurement unit 86 and the storage unit 85.

[0038] The input control unit 83 can receive various data related to the amount of urine to be urinated, including a threshold value for the amount of urine to be urinated, by operating the button 4. This input data can be stored in the storage unit 85 via the measurement unit 86. The threshold value for the amount of urine may be stored in the storage unit 85 in advance.

[0039] The tilt angle of the ultrasonic measuring instrument 1, measured by the gyro sensor 84, is measured immediately after the ultrasonic elements 61a to 61d receive ultrasonic waves and is input to the storage unit 85 via the measurement unit 86.

[0040] The measurement unit 86 includes a urine volume measurement unit 86a, a determination unit 86b, and a measurement completion determination unit. 86 e is included. The urine volume measurement unit 86a calculates the amount of urine stored in the bladder based on reflected wave data for each measurement cycle. The determination unit 86b performs determination processing related to urine volume measurement and includes a maximum value determination unit 86c that determines the maximum value of the calculated amount of stored urine and a position determination unit 86d that determines the position for tilting the ultrasonic measuring device 1. The measurement completion determination unit 86e determines whether the measurement in the measurement mode has been completed.

[0041] The audio processing unit 87 notifies the person being measured by transmitting an alarm from the speaker 5. The alarm may be output when the ultrasound emitted from the ultrasound elements 61a to 61d hits the pubic bone and therefore the ultrasound urine volume data cannot be received, when ultrasound transmission and reception are insufficient due to an air gap between the ultrasound elements 61a to 61d and the lower abdominal surface S1, when the measured urine volume exceeds a set value, or during positioning.

[0042] The display processing unit 88 displays the urine volume calculated by the urine volume measurement unit 86a and various data related to urine volume measurement on the display 3. The communication processing unit 89 outputs the urine volume calculated by the urine volume measurement unit 86a and various data related to urine volume measurement to an external device. In this case, the connection between the ultrasonic measuring device 1 and the external device can be wired or wireless.

[0043] The A / D conversion unit 82 and the measurement unit 86 can be configured with a CPU. The storage unit 85 can be configured with a volatile storage device such as RAM or a non-volatile storage device such as ROM. The ultrasonic control unit 81 can be configured with an ultrasonic control circuit or with a CPU.

[0044] Next, the method for calculating the amount of urine stored in this embodiment will be described. In this embodiment, the ultrasound waves emitted from the ultrasonic elements 61a to 61d are reflected at the boundaries between tissues. Therefore, the ultrasound waves emitted from the ultrasonic elements 61a to 61d toward the bladder are reflected by the anterior and posterior walls of the bladder, and these reflected waves are received by the ultrasonic elements 61a to 61d. Based on these reflected waves, the amount of urine stored is calculated by performing calculations using the ultrasonic A mode described below.

[0045] Figure 9 is a schematic diagram of the waveforms of the reflected waves received by each ultrasonic element 61a to 61d, with the vertical axis representing the reflected intensity and the horizontal axis representing the time from transmission. In the figure, t1 is the time when the reflected wave from the anterior wall of the bladder is detected, and t2 is the time when the reflected wave from the posterior wall of the bladder is detected. If Pi is the peak intensity of the reflected wave from the posterior wall among the waveforms received by the i-th ultrasonic element, and Di is the distance between the peaks of the reflected intensities from the anterior and posterior walls, then the amount of urine stored in the bladder EU can be calculated based on the following equations (1) and (2).

[0046] PD = ΣPi × Di (1) EU = PD × R (2) Here, the 'i' in Pi and Di represents the number assigned to the multiple ultrasonic elements 61a to 61d, and is an integer from 1 to 4. PD represents the average index value obtained by adding the product of the reflected wave intensity Pi and the distance Di between peaks for each of the ultrasonic elements 61a to 61d, for i=1 to 4. EU is the calculated urine volume. R represents a coefficient determined to account for individual differences based on anatomical structure and posture during measurement. Therefore, this average index value PD and urine volume EU are calculated each time ultrasound is transmitted or received by the ultrasonic elements 61a to 61d.

[0047] Next, with reference to Figures 10 to 14, the flow of the ultrasound measurement method according to this embodiment will be described. Figure 10 is a flowchart showing the processing procedure in the ultrasound measuring device. First, the power of the ultrasound measuring device 1 is turned on and the ultrasound measuring device 1 is brought into contact with the upper part of the pubic bone (S101). Here, as shown in Figure 11, the ultrasound measuring device 1 is tilted slightly toward the feet (negative Y-axis direction) so that the first end to the second end of the probe 10 is in contact with the lower abdominal surface S1.

[0048] Next, the probe 10 of the ultrasonic measuring device 1 emits ultrasonic waves from its ultrasonic element and receives reflected waves from the bladder. The urine volume measuring unit 86a calculates equations (1) and (2) based on the reflected wave data (S102). In this embodiment, the urine volume measuring unit 86a repeats the calculation multiple times and uses the moving average of the stored urine volume as measurement data. The measurement data is stored in the storage unit 85 and passed to the determination unit 86b. The measuring unit 86 also passes the measured measurement data to the display processing unit 88. The display processing unit 88 displays an image showing the stored urine volume on the display 3 based on the measurement data.

[0049] Next, as shown by the arrow in Figure 11, the ultrasonic measuring device 1 is moved in a parallel motion, sliding it in the direction of the head (positive Y-axis direction). The urine volume measuring unit 86a continues to calculate the urine volume during the parallel motion and switches the image displayed on the display 3 according to the measurement data (S103).

[0050] The user can adjust the position of the ultrasound measuring device 1 by moving it parallel to the midline while viewing the image of the urine volume displayed on the display 3, so that the urine volume is maximized. If the urine volume exceeds the maximum value, it moves in the foot direction (negative Y-axis direction) as indicated by the arrow in Figure 12(a). Figure 12(b) shows an example of an image displayed on the display 3. The image shown in this figure constitutes a level display 121 that increases or decreases vertically. The level display 121 is displayed in accordance with the urine volume, and for example, one level can represent a urine volume of 100 mL. The number of arranged rectangles is increased or decreased by switching images in step S103. The user can find the position where the level display 121 is highest by checking the changes of the dynamically changing level display 121 in real time while viewing this image. The processing in steps S102 and S103 is repeated until the peak position is found (No in S104). Furthermore, to accommodate visually impaired users, in addition to the level display 121 shown on display 3, the speaker 5 may output a beeping sound with a different pitch depending on the urine volume level to inform the user of the level.

[0051] When the position of the ultrasound measuring device 1 where the urine volume is at its maximum is determined (Yes in S104), the user presses button 4 to instruct a detailed measurement. The position determination unit 86d determines the position at the time button 4 is pressed as the peak position of the urine volume.

[0052] At this point, to begin detailed measurements, speaker 5 may output a voice message such as "Starting measurements."

[0053] Next, the position determination unit 86d acquires information regarding the position and angle of the ultrasonic measuring instrument 1 from the gyro sensor 84 (S105). Then, the position determination unit 86d corrects the coefficient R based on the acquired angle information. As shown in Figure 13(a), the user tilts the ultrasonic measuring instrument 1 so that it draws an arc around the X-axis toward the head direction (positive Y-axis direction) with the first end 45 of the probe 10 as the pivot point. The urine volume measurement unit 86a continues to calculate the urine volume that changes according to the tilt (S106). The urine volume measurement unit 86a repeats the calculation multiple times while the ultrasonic measuring instrument 1 is tilted and uses the moving average of the urine volume as measurement data.

[0054] In this embodiment, when the urine volume measuring unit 86a calculates the urine volume, it applies the value of the coefficient R obtained and corrected in step S105 to equation (2). In this way, a process is performed to correct the value of the urine volume measured during the inclination of the ultrasonic measuring device 1 according to the determined angle of the ultrasonic measuring device 1. Figure 13(b) shows an example of an image displayed on the display 3 in step S106. In the example shown in the figure, the progress of the calculation of the urine volume is indicated by the length of a bar 131 extending from left to right. The display of the progress can be performed according to the measured value. For example, the bar 131 may be displayed to extend as the measured value decreases. Alternatively, the display of the progress can be performed according to the measurement time. In measurement mode, as a guideline, tilt the ultrasonic measuring device 1 at an angle of 30 to 40 degrees relative to the Z-axis. Also, tilt the ultrasonic measuring device 1 over a period of 1 to 5 seconds. When the ultrasonic measuring device 1 is tilted to the predetermined angle, a beeping sound may be emitted from the speaker 5 to inform the user that the measurement is complete.

[0055] Finally, the urine volume measurement unit 86a displays the maximum value of the continuously collected urine volume on the display 3 as the result (S107). Figure 14 shows an example of the display of the collected urine volume level shown in step S107. As shown on the right side of the figure, the collected urine volume can be displayed as a numerical value 141. Alternatively, the collected urine volume may be displayed using four level indicators 142 that are vertically elongated from left to right. In Figure 14, the third level is shown, which indicates that the volume is more than half of the bladder capacity but not the limit. In addition to the display shown in Figure 14, the urine volume may also be announced by voice from the speaker 5.

[0056] In measuring urine volume, measurement of the area behind the pubic bone is important, and it is especially desirable to improve the measurement accuracy of this area when the urine volume is small. In the measurement method according to this embodiment, as shown in Figure 13(a), the ultrasonic measuring device 1 is tilted so as to draw an arc with the vicinity of the first end 45 as the pivot point. Therefore, as the tilt angle increases, the second end 46 moves away from the lower abdominal surface S1, and only the ultrasonic element 61d near the end 45 transmits and receives ultrasound. At this time, the ultrasound emitted from the ultrasonic element 61d can wrap around to the area behind the pubic bone. Measurement using only the ultrasonic element 61d is particularly effective when the urine volume is small.

[0057] Furthermore, according to this embodiment, measurement is possible by only the parallel movement and unidirectional tilting motion of the ultrasonic measuring device 1. In addition, since urine volume can be measured by tilting the ultrasonic measuring device 1, the amount of movement of the ultrasonic measuring device 1 in the Y-axis direction can also be reduced. For this reason, it is also possible to measure the amount of urine collected while sitting.

[0058] Furthermore, by fixing the pivot point when tilting the ultrasonic measuring instrument 1 in measurement mode, operation can be simplified and measurement time can be shortened. In addition, the reproducibility of measurements can be increased and the occurrence of errors can be reduced.

[0059] Furthermore, while actual urine volume measurement requires applying gel to the subject in order to move the ultrasound measuring device 1, this embodiment allows for a narrower range of motion for the ultrasound measuring device 1, thereby reducing the area on which the gel needs to be applied. As a result, the quality of life (QOL) of users utilizing the ultrasound measuring device 1 is improved. [Examples]

[0060] Next, embodiments of the present invention will be described.

[0061] The ultrasonic measuring instrument according to this embodiment uses a probe having a curved surface with a radius of curvature of 140 mm. As a comparative example, an ultrasonic measuring instrument with a flat tip on the probe head was used.

[0062] (Example 1) Figure 15 is a graph plotting the results of measuring urine volume in a supine position using the ultrasonic measuring instrument according to this embodiment. In this graph, the vertical axis represents the calculated urine volume (mL), and the horizontal axis represents the urine volume (mL) measured after the calculation of the measured value. Figure 16 is a graph plotting the results of verifying the accuracy of the ultrasonic measuring instrument according to the comparative example. In Figures 15 and 16, the closer the calculated measured value is to the solid line, the higher the accuracy. The dashed line indicates an error range of ±(15% + 20 mL). Comparing the two figures, it can be seen that the measured values ​​of the ultrasonic measuring instrument according to this embodiment shown in Figure 15 are clustered closer to the solid line, indicating higher accuracy. Figure 17 is a graph plotting the results of measuring urine volume in a seated position using the ultrasonic measuring instrument according to this embodiment. In the figure, the square points represent the measured values. It can be seen that the measured urine volume in a seated position falls within an error range of 15% + 20 mL. In contrast, the results of measuring urine volume in a seated position using the ultrasonic measuring instrument according to the comparative example were clearly less accurate, with many errors and noise.

[0063] (Example 2) Using the ultrasonic measuring device according to this embodiment and the ultrasonic measuring device according to the comparative example, the urine volume was calculated for a specific subject in a supine position. Next, the subject's urination volume was measured. Then, assuming that the measured urination volume represented 95% of the urine volume contained in the bladder, the amount of urine contained in the bladder when 5% of the residual urine volume was measured (urination volume + residual urine volume) was estimated. Hereinafter, this value will be referred to as the estimated urine volume value.

[0064] Table 1 shows the results of measuring urine volume seven times using the ultrasonic measuring instrument according to this embodiment and the ultrasonic measuring instrument according to the comparative example. In the table, measurement-n (where n is a natural number) indicates the measured urine volume at the nth measurement. Here, the estimated urine volume of the subject was 445 mL. In the case of the ultrasonic measuring instrument according to this embodiment, all seven measurements were performed normally, and the error with the measured urine volume was -71 mL. measurement Average time from start to display of judgment result (average) measurement The time was 9 seconds.

[0065] [Table 1]

[0066] Using comparative examples measurement In the seven measurements, errors occurred in two cases. The errors occurred due to abnormalities such as insufficient transmission and reception of ultrasound waves, or when the measured urine volume exceeded the set value. measurement This indicates that it was not possible. In the comparative example, the error was -81 mL. Also, the average measurement The time was 1 minute.

[0067] Figure 18 is a graph showing the measurement results in this embodiment. Figure 18(a) is a graph comparing the average value of the measurement results with the estimated urine volume value. Figure 18(b) is a graph showing the error rate in the measurement. Figure 18(c) is a graph showing the average measurement time. From the results shown in Table 1 and Figure 18, it can be seen that the ultrasonic measuring instrument in this embodiment is less prone to errors and has a small error with the estimated urine volume value. Also, the average measurement It can be seen that the time taken is also shorter than that of the comparative example.

[0068] (Example 3) Table 2 shows the results of seven measurements taken in a supine position with a small urine volume, using the ultrasound measuring device according to this embodiment and the ultrasound measuring device according to the comparative example. The estimated urine volume of the subject was 31 mL.

[0069] [Table 2]

[0070] All measurements in this example were performed normally, and the error with the collected urine volume was 5 mL. measurement The average time was 17 seconds. All measurements in the comparative example were performed normally, and the error with the collected urine volume was -4 mL. Furthermore, measurement The average time was 43 seconds.

[0071] Figure 19 is a graph showing the results of measurements using the ultrasonic measuring instrument according to this embodiment and the ultrasonic measuring instrument according to the comparative example. Figure 19(a) is a graph comparing the average value of the measurement results with the estimated urine volume. Figure 19(b) is a graph showing the average measurement time. As shown in Table 2 and Figure 19, even when the amount of urine in the bladder is small and the ultrasonic echo is weak, the ultrasonic measuring instrument according to this embodiment is less prone to errors and the result shows a small error with the amount of urine contained in the subject's bladder.

[0072] (Second Embodiment) In the above-described embodiment, the user determined the position for starting measurement in measurement mode. Next, an embodiment in which this positioning is performed automatically will be described. The functional configuration of the ultrasonic measuring instrument according to this embodiment is shown in Figure 8, but it differs from the first embodiment in that the position determination unit 86d implements the function of positioning processing.

[0073] Next, with reference to Figures 10 and 20, the flow of the positioning process according to this embodiment will be described.

[0074] Figure 20 is a flowchart showing the positioning procedure in this embodiment. The process shown in Figure 20 corresponds to the peak position determination (S104) shown in Figure 10. First, in step S102, the maximum value Vmax is obtained from the stored measured values ​​(S221). Next, the maximum value Vmax is compared with the latest measured value V. If the comparison result shows that V is greater than or equal to the maximum value Vmax (Yes in S222), the maximum value Vmax is updated to the latest measured value V (S224). Then, the process is repeated from the measurement in step S102.

[0075] On the other hand, if the latest measured value V in step S222 is less than the maximum value Vmax (No in S222), it is determined whether the latest measured value V is below a predetermined threshold (S224). In this embodiment, the predetermined threshold is set to 0.8 times the maximum value Vmax. If, as a result of this determination, the latest measured value V is greater than 0.8 times the predetermined maximum value Vmax (No in S224), it means that the decrease in the measured value is slight. In this case, since there is a possibility that the measured value will increase further, the determination that the system is currently located near the peak position is postponed, and the process is repeated from the measurement in step S102. On the other hand, if the latest measured value V is 0.8 times or less the maximum value Vmax (Yes in S224), it is determined that the position where the maximum value Vmax was measured is the peak position, and the system is currently located near the peak position. The position determination unit 86d determines the current position as the position for starting detailed measurement. At this point, to start the detailed measurement, the speaker 5 may output a voice guidance such as "Starting measurement." After that, the process proceeds to step S105. Since the processing from step S105 onward is the same as in the first embodiment, a detailed explanation will be omitted.

[0076] As described above, according to this embodiment, it is possible to automatically determine the position for detailed measurement without requiring the user to operate any buttons. The above description and figures are intended as examples and are not intended to limit the invention. Those skilled in the art can modify or combine various technical aspects of various elements of the various exemplary embodiments described above. For example, Figure 21 shows an example of a IIIc-IIIc cross-sectional view of a probe head according to a different embodiment from Figures 4 and 5. Unlike the embodiments described above, recesses 211 to 218 are formed on the inner wall of the probe head 210, into which an array of eight ultrasonic elements are mounted. Furthermore, of the surface C3 of the probe head 210, the portion corresponding to the recesses 215 to 218 is parallel to the plane S2, while the portion corresponding to the recesses 211 to 214 has a curved surface with a radius of curvature of 140 mm. Such modifications of the embodiments described above are also considered to be within the scope of the present invention. Furthermore, in the measurement method of the measurement mode described above, the ultrasonic measuring device 1 was tilted towards the head during measurement, but this is only one example. For example, as shown in Figure 12, the ultrasonic measuring device 1 may be tilted slightly from vertical towards the feet and pressed against the head during measurement. [Explanation of Symbols]

[0077] 1 Ultrasonic measuring device 2 Main body 3 displays 4 buttons 5 speakers 6. Communication Interface 10 probes 40 probe heads 61a, 61b, 61c, 61d Ultrasonic element 80 Control Unit 81 Ultrasonic Control Unit 82 A / D Conversion Section 83 Input Control Unit 84 Gyroscope Sensor 85 Storage section 86 Measuring section 86a Urine volume measuring section 86b Judgment part 86c Maximum value determination unit 86d Position determination section 86e Measurement completion determination unit 87. Audio Processing Unit 88 Display Processing Unit 89 Communication Processing Unit 150 Ultrasound measurement Container (comparative example) 151 Probe (Comparative Example) 152 Main body (comparative example)

Claims

1. A probe having an array of ultrasonic elements that emit ultrasound towards structures within a living organism, A measuring unit that measures the state of the structure based on reflected waves from the structure. An ultrasonic measuring instrument equipped with, An ultrasonic measuring instrument comprising a probe having a probe head that contacts a living body, the probe head having a first end positioned on the head side of the living body when in contact with the living body, and a second end positioned on the pubic side of the living body, and having a convex curved surface that slopes such that when the probe head is viewed from the side, the height of the probe head becomes thinner from the first end to the second end.

2. The ultrasonic measuring instrument according to claim 1, wherein the curved surface includes an arc with a predetermined radius of curvature.

3. The ultrasonic measuring instrument according to claim 2, wherein the radius of curvature is 100 mm to 200 mm.

4. The ultrasonic measuring instrument according to claim 1, wherein the inner wall of the probe head on which the arrangement of ultrasonic elements is mounted is inclined along the curved surface.

5. The ultrasonic measuring instrument according to claim 1, wherein the thickness of the inner wall of the probe head in the portion where the arrangement of ultrasonic elements is mounted is greater than 0 mm and less than 2 mm.

6. The ultrasonic measuring device according to claim 1, wherein the ultrasonic measuring device is a urine volume measuring device, and the state of the structure is the amount of urine in the bladder.

7. An ultrasonic measurement method using an ultrasonic measuring instrument equipped with a probe having an array of ultrasonic elements that emit ultrasonic waves into a living body, wherein the probe has a probe head that contacts the living body, the probe head has a first end that is positioned on the head side of the living body when in contact with the living body, and a second end that is positioned on the pubic bone side of the living body, and the probe head has a convex curved surface that slopes such that when viewed from the side, the height of the probe head becomes thinner from the first end to the second end. The step of bringing the curved surface into contact with the surface of the living organism such that the first end to the second end is in contact with the surface of the living organism, The steps include: emitting ultrasonic waves from the ultrasonic element; A step of measuring the state of the structure based on the reflected waves from the structure within the living organism. Ultrasonic measurement methods, including

8. The process further includes the step of tilting the ultrasonic measuring instrument toward the head side with the vicinity of the first end as a pivot point, The ultrasonic measurement method according to claim 7, wherein the measurement step involves measuring the condition of the structure while the ultrasonic measuring instrument is tilted.

9. The further step includes moving the ultrasonic measuring instrument in parallel while the curved surface is in contact with the surface of the living organism, The ultrasonic measurement method according to claim 8, wherein the measurement step includes measuring the state of the structure while the ultrasonic measuring instrument is moving in parallel, and determining the position on the surface of the living body to start the tilting step based on the results of the measurement.

10. The step of determining the position further includes a step of determining the angle of the ultrasonic measuring instrument when the position is determined, The ultrasonic measurement method according to claim 9, wherein the measurement step involves tilting the ultrasonic measuring instrument according to the determined angle to correct the value of the state of the structure being measured.

11. The ultrasonic measuring method according to any one of claims 7 to 10, wherein the ultrasonic measuring device is a urine volume measuring device, the state of the structure is the amount of urine in the bladder, and the contact step involves bringing the curved surface into contact with the surface of the living body such that the first end is located on the head side of the living body and the second end is located on the pubic side of the living body.

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