JP2011183142A - Non-invasive urine volume estimation sensor unit, non-invasive urine volume estimation device, and urination management system - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a non-invasive collected urine volume estimation sensor unit and a non-invasive collected urine volume estimation device capable of estimating a collected urine volume with high accuracy over a wide range from a small collected urine volume to a large collected urine volume, and furthermore to provide a urination management system for easily managing urine collection/non-urination of a patient utilizing this non-invasive collected urine volume estimation device. <P>SOLUTION: The non-invasive collected urine volume estimation sensor unit 21 is composed of a plurality of sensors 22 with ultrasonic vibrators, and has a sensor group 23 set to the arrangement and ultrasonic emission angle so that each sensor can detect a bladder shape. The non-invasive collected urine volume estimation device includes this non-invasive collected urine volume estimation sensor unit 21 and the processing part for estimating the urine volume by measuring the three-dimensional shape of the bladder by detecting the ultrasonic wave reflected from the bladder of the ultrasonic wave oscillated from this sensor unit 21. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a non-invasive urine volume estimation sensor unit, a non-invasive urine volume estimation device, and a urination management system. In particular, for patients with dysuria or urinary incontinence, the urine management information including the amount of urine collected in the bladder (urine accumulation and residual urine volume) and other information is measured in advance by measuring the shape of the bladder. The present invention relates to a technique suitable for application to cases where urine accumulation / urination management of a patient is performed based on management information and is useful for diagnosis and treatment.

  Conventionally, an ultrasonic urine volume sensor shown in Patent Document 1, an urine volume sensor using ultrasonic waves shown in Patent Document 2, and the like are known as urine accumulation volume estimation devices. The ultrasonic urine volume sensor of Patent Document 1 is commercially available as a portable urine volume monitor device under the trade name “Yuririn”.

  As shown in FIGS. 27 and 28, the ultrasonic urine volume sensor 1 disclosed in Patent Document 1 has four ultrasonic oscillation elements that oscillate ultrasonic waves toward the bladder wall surface, that is, the sensor 2 is arranged in the vertical direction. The probe (probe) 3 is provided. Each sensor 2 is arranged with the sensor angle directed only in the vertical direction. This probe 3 is mounted on the surface of the lower abdomen, irradiates the ultrasound 5 from the four sensors 2 to the bladder 5 side, detects and processes reflected echoes from the front wall 5A and the rear wall 5B of the bladder 5 The amount of stored urine is detected by detecting expansion of the bladder 5. FIG. 27 shows the emission state of the ultrasonic wave 4 as seen in a cross section, and the bladder capacity at this time, that is, the urine accumulation amount is about 200 cc. FIG. 28 shows the expanded state of the bladder 5 at about 50 cc, about 350 cc, and about 600 cc of the bladder capacity. Reference numeral 6 indicates the pubic bone, and reference numeral 7 indicates the peritoneum.

  As shown in FIGS. 24 to 26, the urine accumulation sensor 11 disclosed in Patent Document 2 includes an ultrasonic oscillation element, that is, a probe (probe) 13 in which sensors 12 are arranged two-dimensionally in the vertical and horizontal directions. Is done. In the probe 13 of this example, as shown in FIG. 24, a total of twelve sensors 12 [(1) to (12)] of 4 × 3 are arranged and faced in different directions. The probe 13 is attached to the surface of the lower abdomen, and the ultrasonic wave 14 from each sensor 12 passes through the limited gap 18 between the pubic bone 16 and the peritoneum 17 and corresponds to the vicinity of the front wall 15A of the bladder 15. It intersects at the part where it spreads and spreads three-dimensionally and is directed to the rear wall 15B of the bladder 15. In this urine accumulation sensor 11, by using the ultrasonic wave 14 that expands three-dimensionally after the intersection, the three-dimensional shape of the bladder 15 can be measured more accurately, and the urine accumulation amount can be detected more accurately. In this probe 13 as well, basically, the reflected echoes of the emitted ultrasound 14 from the front wall 15A and the rear wall 15B of the bladder 15 are detected and processed in the same manner as described above. FIG. 15 shows an emission state of the ultrasonic wave 14 as seen in a cross section, and shows that the bladder capacity at this time, that is, the urine accumulation amount is about 200 cc. FIG. 25 shows the expanded state of the bladder 5 as bladder capacity of 50 cc, 350 cc, and 600 cc.

WO2005 / 099582 WO 2006/115278

  In the meantime, in the ultrasonic urine volume sensor 1 shown in FIGS. 27 and 28, the sensor angle is only in the vertical direction, the lateral spread of the bladder cannot be captured, and only urine volume estimation can be performed in stages.

  In the urine accumulation amount sensor 11 shown in FIGS. 25 and 26, the ultrasonic waves 14 cross and spread at portions corresponding to the vicinity of the bladder front wall 15A, and are directed to the rear wall 15B. For this reason, a wide range of measurement is possible on the rear wall 15B, but there is little measurement information on the front wall 15A portion, and it is difficult to estimate when the amount of stored urine is large. That is, the left and right regions (shown by broken lines) 19 of the front wall 15A at the time of bladder inflation shown in FIG. 26 cannot be measured. Also in this case, since the urine volume is estimated on the assumption that the bladder 5 is spherical, there is a problem in measurement accuracy unlike the actual bladder shape, and it is impossible to measure a small urine accumulation volume (about 50 cc). . In particular, since the sensor angle of the sensor 12 [(1) to (3)] is large, the sensor 12 is easily affected by attenuation in the skin and the fat layer.

In view of the above-described points, the present invention provides a non-invasive urine volume estimation device and a non-invasive urine volume estimation device capable of estimating urine accumulation volume and urination volume with high accuracy over a wide range from small urine volume to large urine volume. The present invention provides a non-invasive urine volume estimation sensor unit (so-called probe) that is applied to the above.
The present invention provides a urination management system that enables urine accumulation / urination management of a patient using the noninvasive urine volume estimation device.

  The non-invasive urine volume estimation sensor unit according to the present invention is composed of a plurality of sensors based on ultrasonic vibration, and includes a sensor group in which each sensor can detect a bladder shape and an ultrasonic emission angle is set. Is done.

  The preferable form of the sensor group of the non-invasive urine volume estimation sensor unit according to the present invention includes a first sensor unit including a plurality of sensors that emit ultrasonic waves with a two-dimensional spread and detect the shape of the bladder bottom. . Furthermore, it has the 2nd sensor part which is radiate | emitted with three-dimensional expanse and consists of a some sensor which detects the expansion height of a bladder.

  In the non-invasive urine volume estimation sensor unit of the present invention, the sensor group can capture the shape change of the bottom of the bladder and the height of the bulged bladder, and the bladder shape close to the actual can be captured.

  A noninvasive urine volume estimation device according to the present invention includes the above-described noninvasive urine volume estimation sensor unit. Furthermore, the present invention detects the reflected ultrasound from the bladder wall of the ultrasonic wave oscillated from each sensor of the sensor group of the non-invasive urine volume estimation sensor unit, calculates the three-dimensional shape of the bladder, and calculates the urine. A processing unit for estimating the quantity is provided.

  In the noninvasive urine volume estimation device of the present invention, the noninvasive urine volume estimation sensor unit can capture the shape change of the bladder bottom and the height of the bulged bladder. Thereby, a three-dimensional shape close to the actual bladder is measured, and the bladder capacity can be continuously measured (estimated) from a small capacity to a large capacity.

  The urination management system according to the present invention detects the reflected ultrasound from the bladder wall of the ultrasonic wave oscillated from each sensor of the noninvasive urine volume estimation sensor unit and the sensor group of the noninvasive urine volume estimation sensor unit. And a non-invasive urine volume estimation device having a processing unit that calculates and measures the three-dimensional shape of the bladder to estimate the urine volume. In addition, it has a data processing / data storage device for processing and storing measurement data from the non-invasive urine volume estimation device. In the present invention, this noninvasive urine volume estimation device and the data processing / data storage device constitute a urination data recording device. Further, the present invention, together with this urination data recording device, analyzes urination information including urination time and urination volume sent from the urination data recording device to obtain and store urine management information including diagnostic information and urination diary A urination data analysis device. The diagnostic information includes urine flow rate curve data by continuous measurement obtained by analyzing urination information sent from the urination data recording device, and the amount of residual urine obtained by ensuring accuracy at a small amount. Based on the urine management information, urine accumulation / urination management of the patient is performed.

  In the urination management system of the present invention, urination information is recorded on the patient side using the so-called non-invasive urine volume estimation device having a non-invasive urine volume estimation sensor unit and a processing unit. Based on the urination information, urine management information useful for diagnosis / treatment of the patient, such as urine flow rate, urination time, and residual urine volume, is calculated on the facility side such as a hospital, and the urine storage / urination management of the patient is performed.

  A noninvasive urine volume estimation device according to the present invention includes the above-described noninvasive urine volume estimation sensor unit. In particular, according to the present invention, two or more ultrasonic transducers are used so that the sensor group has the largest number of sensors emitted to the bottom of the bladder and has a plurality of sensor rows from the bottom side to the top. A non-invasive urine volume estimation sensor unit arranged in a dimension is provided. Furthermore, the present invention detects the reflected ultrasound from the bladder wall of the ultrasonic waves oscillated from each sensor of the sensor group of the non-invasive urine volume estimation sensor unit, calculates the bladder volume, and estimates the urine volume. A processing unit is provided.

  The processing unit includes a calculation unit that calculates the bladder volume by the truncated cone approximation method based on the A-mode waveform that is the positional information of the anteroposterior bladder wall received by each sensor.

In the calculation unit, the depth D of the bladder at each bladder height obtained from each sensor based on the received waveforms in the A mode at a plurality of sensors with different angles in the vertical direction arranged in the sensor rows of the vertical stages. _i is measured. A horizontal cross-sectional area S _{0 serving} as a reference plane of the bladder and a depth D ₀ of the bladder at the reference plane are measured by a plurality of lowermost sensors corresponding to the upper pubic bone. Using the horizontal sectional area S ₀ of the reference plane, the depth D ₀ at the reference plane, and the depth D _i at each bladder height, the horizontal sectional area S _i of the bladder at each bladder height position calculated by Equation 1 Ask for.
The frustoconical volume V _i of each bladder cut at each height Δh defined by the difference in each bladder height is calculated from the horizontal cross-sectional areas S _i , S _{i + 1} of the respective bottom and top surfaces and the height Δh according to Equation 2. And ask.
The bottom of the bladder hidden behind the pubic bone is estimated as a hemispherical volume, the uppermost portion of the bladder is estimated as a conical volume, and the total volume of the bladder is calculated by adding the respective truncated cone volumes, the hemispherical volume, and the conical volume.

  In the non-invasive urine volume estimation device of the present invention, a urine volume closer to the actual urine volume can be estimated by providing a processing unit that calculates the bladder volume by the truncated cone approximation method and estimates the urine volume.

  The urination management system according to the present invention includes a non-invasive urine volume estimation device that estimates a bladder volume by the truncated cone approximation method, and data that processes and stores measurement data from the non-invasive urine volume estimation device A urination data recording device having a processing / data storage device is provided. Furthermore, the present invention includes a urine data analysis device that analyzes urination information including urination time and urination volume sent from the urination data recording device, and obtains and stores urine management information including diagnostic information and a urination diary. . The diagnosis information includes the urine flow rate curve data obtained by analyzing the urination information sent from the urination data recording device and the residual urine amount obtained by ensuring the accuracy when the amount is small. Based on the obtained urine management information, urine accumulation / urination management of the patient is performed.

  The urination management system of the present invention includes a non-invasive urine volume estimation device that estimates the urine volume by obtaining the bladder volume by the truncated cone approximation method, so that more accurate urine management information can be calculated to manage urine accumulation / urination management of the patient. Made.

  According to the non-invasive urine volume estimation sensor unit according to the present invention, it is possible to capture a wide range of realistic bladder shapes from a contracted bladder to a swollen bladder. This non-invasive urine volume estimation sensor unit enables accurate measurement of the bladder shape regardless of the patient's posture.

  According to the noninvasive urine volume estimation device according to the present invention, it is possible to estimate the urine volume with high accuracy over a wide range from a small urine volume to a large urine volume.

  According to the urine management system according to the present invention, the non-invasive urine volume estimation device having the non-invasive urine volume estimation sensor unit and the processing unit of the present invention can be applied to perform urine accumulation / urination management of a patient. This urine management information subjected to urine accumulation / urination management can be applied to diagnosis / treatment of urination disorder patients.

  According to the non-invasive urine volume estimation device according to the present invention, since the processing unit for estimating the urine volume by obtaining the bladder volume by the truncated cone approximation method is provided, it is higher in a wide range from a small urine volume to a large urine volume. The urine volume close to the actual urine volume can be estimated with accuracy.

  The urination management system according to the present invention includes a processing unit that estimates the urine volume by obtaining the bladder volume by the truncated cone approximation method, and can calculate more accurate urine management information. Practical use of urine storage / urination management can be achieved.

It is a schematic perspective view which shows one Embodiment of the noninvasive urine volume estimation sensor unit which concerns on this invention. It is a schematic sectional drawing which shows the measurement range of the bladder shape at the time of the small urine volume by the noninvasive urine volume estimation sensor unit of this invention. It is a schematic plan view which shows the measurement range of the bladder shape at the time of the small urine volume by the noninvasive urine volume estimation sensor unit of this invention. It is a schematic sectional drawing which shows the measurement range of the bladder shape at the time of normal urine volume by the noninvasive urine volume estimation sensor unit of this invention. It is a schematic plan view which shows the measurement range of the bladder shape at the time of normal urine volume by the noninvasive urine volume estimation sensor unit of this invention. It is a schematic sectional drawing which shows the measurement range of the bladder shape at the time of many urine volume by the noninvasive urine volume estimation sensor unit of this invention. It is a schematic plan view which shows the measurement range of the bladder shape at the time of the large amount of urine by the noninvasive urine volume estimation sensor unit of the present invention. It is a circuit block diagram which shows an example time of the process part of the noninvasive urine volume estimation sensor unit by this invention. It is a use condition figure of the ultrasonic probe used for the measurement of the shape change of a bladder. It is an image figure which shows the reflective echo image of the ultrasonic wave which shows the shape change of a bladder. It is a schematic block diagram of a urination management system by this invention. It is a graph which shows the relationship between the measurement urine flow volume computed from the measured actual urine output, and time. It is the graph which compared the actual urine accumulation volume curve of the bladder computed based on the measurement with the conventional urine flow measuring device, and the estimated urine accumulation amount curve of the bladder obtained by the noninvasive urine accumulation amount estimation device of the present invention. A and B are a horizontal sectional view and a sagittal sectional view showing bladder echo images. The A mode by the ultrasonic transducer is a waveform diagram. A, B A horizontal sectional view showing a state of trajectory of ultrasonic waves from a plurality of sensors arranged in a horizontal direction, and a state of trajectory of ultrasonic waves from a plurality of sensors arranged in a vertical direction, for explaining the bladder volume calculation method of the present invention. FIG. It is a perspective view which shows the decomposer static state of the urinary bladder used for description of the truncated cone approximation method. It is CT image figure of the abdominal part with which it uses for description of the bladder volume calculation method of this invention. It is a graph which shows the bladder volume and the actual volume estimated on the basis of the pubic upper part and the largest horizontal cross section. It is a horizontal sectional view showing a measurement range when using a specific example of a sensor unit applied to the bladder volume calculation method of the present invention. It is sagittal sectional drawing which shows the measurement range when the specific example of the sensor unit applied to the bladder volume calculation method of this invention is used. It is a wave form diagram which shows the A mode waveform of the bladder obtained from all the sensors of a sensor unit required for description of the bladder volume calculation method of this invention. It is a graph which shows the estimated urine volume obtained by the bladder volume calculation method of this invention, and the actual urination volume. It is a schematic perspective view which shows the ultrasonic urine volume sensor which concerns on an example of the past. It is a schematic sectional drawing which shows the range of the measurement of the ultrasonic urine volume sensor and bladder urine volume which concerns on an example of the past. It is a schematic plan view which shows the range of the measurement of the ultrasonic urine volume sensor and bladder urine volume which concerns on an example of the past. It is a schematic sectional drawing which shows the range of the measurement of the ultrasonic urine volume sensor and bladder urine volume which concerns on the other conventional example. It is a schematic plan view which shows the range of the measurement of the ultrasonic urine volume sensor and bladder urine volume which concerns on the other conventional example.

  Embodiments of the present invention will be described below with reference to the drawings.

  First, a change in the bladder shape with the amount of urine stored will be described. 9 and 10A to 10C show changes in the bladder shape. FIG. 10A shows the shape of the bladder 45 when the urine accumulation amount is small, for example, about 78 cc. FIG. 10B shows the shape of the bladder 45 when the urine accumulation amount is medium, for example, about 286 cc. FIG. 10C shows the shape of the bladder 45 when the amount of accumulated urine is large, for example, about 532 cc. The reflected echo image showing the bladder shape in FIG. 10 includes an ultrasonic probe 41 (sagittal cut) in which the ultrasonic wave 43 shown in FIG. 9 spreads in the vertical direction and an ultrasonic probe in which the ultrasonic wave 43 spreads in the horizontal direction. Observed at 42 (horizontal section). 10A to 10C, the upper image is a reflected echo image in which the bladder is inflated in the vertical direction by the ultrasonic probe 41, and the lower image is a reflected echo image of the bottom shape of the bladder by the ultrasonic probe 42. is there. Reference numeral 46 in FIG. 9 indicates the pubic bone.

  As is apparent from the bladder images of FIGS. 10A to 10C, the bladder first swells in a flat shape, and as the urine volume increases, the top pushes up the peritoneum and swells in a dome shape. That is, when the bladder 45 is expanded, the bottom portion first swells, and the top portion swells in a dome shape as the urine volume increases. Further, when the bladder 45 contracts, the opposite change occurs. The embodiment of the non-invasive urine volume estimation sensor unit according to the present invention is configured to cope with such a change in the bladder shape.

  FIG. 1 shows an embodiment of a non-invasive urine volume estimation sensor unit according to the present invention. The non-invasive urine volume estimation sensor unit 21 according to the present embodiment is composed of a plurality of sensors 22 [(1) to (12)] using ultrasonic vibrations. The sensor group 23 is set to the sound wave emission angle. Further details will be described. In the non-invasive urine volume estimation sensor unit 21 according to the present embodiment, a plurality of sensors 22 [(1) to (12)] using ultrasonic transducers are two-dimensionally arranged and ultrasonic waves toward the bladder 25 side. The sensor group 23 which radiates | emits 24 in three dimensions radially is provided (refer FIG. 2, FIG. 3). The sensor group 23 is configured to have the largest number of sensors emitted to the bottom of the bladder and to have a plurality of sensor rows 221 to 224 from the bottom side toward the top. The sensor row refers to a plurality of sensors arranged along a horizontal line. The support portion 29 on which the sensor 22 is supported may be triangular, quadrangular, other shapes, and each sensor row may be independent.

  In the present embodiment, four stages of sensor rows 221 to 224 each having a plurality of sensors 22 arranged along a horizontal line are sequentially supported by the support section 29 so as to face the surface 29a of the support section 29 having a triangular shape. Thus, a sensor group is configured. The sensor rows 224 to 221 ”are arranged from the bottom side to the top side. The sensor row 224 is configured by arranging five sensors 22 [(8) to (12)] emitted to the bottom of the bladder along a horizontal line. The sensor row 223 is configured by arranging three sensors 22 [(5) to (7)] along a horizontal line. The sensor row 222 is configured by arranging two sensors 22 [(3) to (4)] along a horizontal line. The sensor row 221 is configured by arranging two sensors 22 [(1) to (2)] along a horizontal line. In the first sensor row 221 on the top side, two sensors 22 [(1) to (2)] are arranged close to each other. The second sensor row 222 is arranged so as to be separated by two sensors 22 [(3) to (4)]. In the third sensor row, three sensors 22 [(5) to (7)] are arranged close to each other. In the fourth sensor row 224 on the bottom side, five sensors 22 [(8) to (12)] are arranged close to each other. In each of the sensor rows 221 to 224, the sensors 22 are arranged so as to be symmetric with respect to a vertical line passing through the top of the support portion having a triangular shape.

  The sensor angle, that is, the emission direction of the ultrasonic wave 24 is selected for each sensor 22 of the sensor group 23 together with the above arrangement so as to be able to cope with changes in the bladder shape. In other words, the sensors 22 are arranged in different directions so as to capture changes in the shape of the bottom of the bladder and changes in the height of inflation of the bladder. In the sensor group 23, the ultrasonic wave 24 from each sensor 22 passes through a limited gap 28 between the peritoneum 27 and the pubic bone 26 according to the bladder shape, as shown in FIGS. It oscillates radially and captures a wider range of reflected ultrasound (reflected echo) from the bladder wall.

  In the fourth-stage sensor row 224 on the bottom side, as shown in FIG. 3, the left and right sensors 22 [(8), (9) with the ultrasonic wave 24 from the center sensor 22 (10) as viewed from above are sandwiched. , (11), (12)], the ultrasonic waves 24 spread symmetrically. As a result, as shown in FIG. 2, the ultrasonic wave 24 from the sensor 22 [(8) to (12)] spreads in the vertical direction so that the bladder shape at the time of a small amount of urine can be detected as viewed from the longitudinal section. Become.

  Similarly, in the third sensor row 223, as shown in FIG. 3, the left and right sensors 22 [(5), (7)] sandwiching the ultrasonic wave 24 from the center sensor 22 (6) as viewed from above. The ultrasonic wave 24 from the sound beam spreads symmetrically. As a result, as shown in FIG. 2, the ultrasonic wave 24 from the sensor 22 [(5) to (7)] spreads in the vertical direction so that the bladder shape can be detected as viewed from the vertical cross section.

  In the second sensor row 222, as shown in FIG. 3, the ultrasonic waves 24 from the two sensors 22 [(3), (4)] are spread after crossing as viewed from above. As a result, as shown in FIG. 2, the ultrasonic wave 24 from the sensor 22 [(3), (4)] spreads in the vertical direction so that the bladder shape can be detected as viewed from the vertical cross section.

  In the first sensor row 221 on the top side, the ultrasonic waves 24 from the left and right sensors 22 [(1), (2)] spread symmetrically across the center line when viewed from above. As a result, as shown in FIG. 2, the ultrasonic wave 24 from the sensor 22 [(1), (2)] spreads in the vertical direction so that the bladder shape can be detected as viewed from the vertical cross section.

  In the sensor 22, the ultrasonic emission angle θ1 when viewed from the plane is about 12.5 degrees at the maximum (see FIG. 3), and the ultrasonic emission angle θ2 when viewed from the longitudinal section is about 10 degrees at the maximum ( 2). The reason why the maximum is about 12.5 degrees is that when the ultrasonic penetration angle into the skin is increased, attenuation due to reflection occurs.

  In the sensor group 23, the shape change mainly on the bladder bottom side is captured by the ultrasonic waves 24 emitted from the sensors 22 [(8) to (12)] in the fourth-row sensor row 224 on the bottom side. The height of inflation of the bladder 25 is mainly captured by the ultrasonic waves 24 emitted from the sensors 22 [(1) to (7)] of the other sensor rows 221 to 223 except for the sensor row 224 of the fourth stage on the bottom side. .

  Each sensor 22 is formed with electrodes on both sides of the piezoelectric element, and when a voltage is applied between both electrodes, the piezoelectric element vibrates to transmit an ultrasonic wave. Conversely, when receiving an ultrasonic wave, a voltage is applied from both electrodes. Is configured to be induced. The sensor 22 is formed in, for example, a circular thin plate shape. Each sensor 22 is supported on the support portion 29 so that the angle can be variably set.

  The sensor 22 is embedded in a filler that serves as a matching layer in order to prevent large reflections of ultrasonic waves due to differences in acoustic impedance. When the non-invasive urine volume estimation sensor unit 21 is mounted on the lower abdomen surface, the non-invasive urine volume estimation sensor unit 21 is mounted, for example, via an echo gel so that no air exists between the non-invasive urine volume estimation sensor unit 21 and the lower abdomen surface.

  The non-invasive urine volume estimation sensor unit 21 is used in an A mode type in which ultrasonic waves are transmitted one by one while sequentially scanning each sensor 22 [(1) to (12)]. In the case of bladder shape measurement, the sensor 22 may be any sensor that emits ultrasonic waves of about 1 MHz to 5 MHz.

  In the noninvasive urine volume estimation sensor unit 21 of the present embodiment, the sensor 22 [(1) to (12)] is sequentially driven by being attached to the lower abdomen. Then, of the ultrasonic waves transmitted from each sensor 22, according to the swelling of the bladder, the ultrasonic waves transmitted through the gap 28 between the peritoneum 27 and the pubic bone 26 are irradiated to the bladder 25 side (for example, FIGS. 2 and 3). reference). Then, the ultrasonic waves reflected by the front wall and the rear wall of the bladder 25 are received by the same sensor 22 as at the time of emission, and the reception signals corresponding to the positions of the front wall and the rear wall of the bladder 5 are detected by the sensor 22.

  According to the non-invasive urine volume estimation sensor unit 21 according to the present embodiment, the sensors 22 [(8) to (12)] of the fourth-stage sensor row 224 which is mainly the first sensor unit in the sensor group 23. Ultrasonic waves are emitted with a two-dimensional spread. The position of the front wall and the rear wall corresponding to the shape of the bottom of the bladder can be detected by the sensors 22 [(8) to (12)] of the fourth sensor row 224. That is, as a result, the shape of the bottom of the bladder is detected. The spread of the ultrasonic wave from the fourth sensor row 224 is mainly a two-dimensional spread, but more specifically, has a three-dimensional spread spreading in the vertical direction. A three-dimensional spread from the sensors 22 [(1) to (7)] of the sensor rows 221 to 223 of the first, second, and third stages, which are mainly the second sensor section in the sensor group 23. An ultrasonic wave is emitted. The position of the front wall and the rear wall corresponding to the expanded bladder shape can be detected by the sensors 22 [(1) to (7)] of the first, second, and third sensor rows 221 to 223. . That is, as a result, the expanded height of the bladder is detected.

Therefore, the sensor group 23 can capture the bladder shape close to the actual state of the contracted state after urination and the state of being stored and expanded. This non-invasive urine volume estimation sensor unit 21 enables accurate measurement of the bladder shape regardless of the patient's body position.

  Next, the noninvasive urine volume estimation apparatus according to the present invention will be described with reference to FIG. A non-invasive urine volume estimation device 30 according to the present embodiment includes the above-described non-invasive urine volume estimation sensor unit 21 and a processing unit 31. In the processing unit 31, the reflected ultrasound (reflected echo) from the bladder wall of the ultrasonic wave 24 oscillated from each sensor 22 of the sensor group 23 of the sensor unit 21 is detected and processed to measure the three-dimensional shape of the bladder 25. And estimate the amount of urine.

  FIG. 8 shows an example of the processing unit 31. The processing unit 31 includes a bladder shape measuring unit 32 that measures the bladder shape, and a urine volume estimating unit 33 that estimates the amount of accumulated urine from the bladder shape obtained by the bladder shape measuring unit 32. The bladder shape measuring unit 32 includes a transmission control unit 45 and a signal processing unit 46. In the transmission control unit 45, the plurality of sensors 22 are sequentially transmitted. In the signal processing unit 46, the reflected ultrasound reflected by the front wall 25A and the rear wall 25B of the bladder 25 is received by the sensor 22, and the positions of the front wall 25A and the rear wall 25B of the bladder are calculated from the obtained reception signals. The three-dimensional shape of the bladder 25 is measured.

  Each sensor 22 [(1) to (12)] is connected to an ultrasonic transmission amplifier 52 and an ultrasonic reception amplifier 53 via a multiplexer 51. The ultrasonic transmission amplifier 52 is connected to a pulse transmission circuit 54 that sequentially outputs pulse signals to the plurality of sensors 22. A pulse control circuit 55 is connected to the pulse transmission circuit 54 and controls the pulse width, amplitude, period, number of transmissions, pulse train period, etc. of the pulse signal. The ultrasonic transmission amplifier 52 has a function of amplifying a signal from the pulse transmission circuit 54 and increasing electric energy sufficient to transmit ultrasonic waves. The ultrasonic receiving amplifier 53 has a function of amplifying the received weak electric signal. The multiplexer 51 is located between the sensor 22 and the ultrasonic transmission amplifier 52 and the ultrasonic reception amplifier 53. The multiplexer 51 sequentially connects the sensors 22 and the amplifiers 52 and 53, and all the sensors 22 are sequentially connected by one amplifier. Has a function to operate.

  The ultrasonic reception amplifier 53 and the pulse transmission circuit 54 are connected to a signal processing circuit 56. The signal processing circuit 56 A / D converts the reception signal from the ultrasonic reception amplifier 53 in synchronization with the transmission signal of the pulse transmission circuit 54. The position of the front wall 25A and the position of the rear wall 25B of the bladder 25 is calculated from the A / D converted received signal data, and the bladder wall surface is mapped. By performing the same operation on the transmission signals and reception signals of all the sensors 22, the three-dimensional shape of the bladder 22 is determined.

  The urine volume estimation unit (that is, the urine volume estimation circuit) 33 calculates from the three-dimensional data of the bladder 25 obtained by the signal processing circuit 56 to estimate the bladder urine volume.

  Next, the measurement (estimation) of the shape of the bladder and the urine volume based on the bladder shape will be described using the noninvasive urine volume estimation device 30 provided with the processing unit 31.

  The non-invasive urine volume estimation sensor unit 21 is mounted on the surface of the lower abdomen so that the fourth-stage sensor row 224 on the bottom side is on the lower side. In the processing unit 31, a pulse signal is output from the pulse transmission circuit 54 based on the control signal from the pulse control circuit 55, and the ultrasonic waves 24 are sequentially emitted from the plurality of sensors 22 of the sensor group 23 through the ultrasonic transmission amplifier 52. . An ultrasonic wave is transmitted from each sensor 22 every required time, for example, every second. According to the swelling of the bladder 25, the ultrasonic wave 24 passing through the gap 28 between the peritoneum 27 and the pubic bone 26 is irradiated to the bladder 25 side. The ultrasonic wave 24 is reflected by the front wall 25 </ b> A and the rear wall 25 </ b> B of the bladder 25 and is received by the same sensor 22. In the signal processing circuit 56, the reception signal from the ultrasonic reception amplifier 53 is A / D converted in synchronization with the transmission signal of the pulse transmission circuit 54. The positions of the front wall 25A and the rear wall 25B of the bladder 25 are calculated from the A / D converted received signal data, and the three-dimensional shape of the bladder is measured.

  Next, the urine volume estimation circuit 33 measures (estimates) the urine volume such as the accumulated urine volume or the urine volume from the three-dimensional shape data of the bladder 25.

  2 and 3 show measurement of urine volume (including residual urine volume) at a small amount. When the amount of urine is small (50 cc or less), the ultrasonic waves 24 from the five sensors 22 [(8) to (12)] in the fourth sensor row 224 on the bottom side of the sensor group 23 are The light passes through the gap 28 between the peritoneum 27 and the pubic bone 26 and is emitted three-dimensionally radially to the bladder 25 side. The ultrasonic waves 24 emitted from the five sensors 22 [(8) to (12)] capture the shape change of the bladder bottom. This makes it possible to measure (estimate) a small amount of urine of 50 cc or less with high accuracy.

  4 and 5 show the measurement of urine volume (including urination volume) at the normal volume. When the urine volume is a normal volume, the ultrasonic waves 24 from the eight sensors 22 [(5) to (12)] in the sensor rows 224 and 223 in the fourth and third stages in the sensor group 23 are The light passes through the gap 28 between the peritoneum 27 and the pubic bone 26 and is emitted three-dimensionally radially to the bladder 25 side. The ultrasonic wave 24 emitted from the eight sensors 22 [(5) to (12)] captures the shape change including the upper part of the bladder that is swollen in a dome shape from the bottom of the bladder. Thereby, a normal urine volume of about 200 cc can be measured (estimated) with high accuracy.

    6 and 7 show the measurement of the urine volume when there is a large amount (such as dysuria). When the amount of urine is large, the ultrasonic waves 24 from the twelve sensors 22 [(1) to (12)] in the sensor rows 221 to 224 in the first to fourth stages in the sensor group 23 are peritoneum. The light is transmitted through the gap 28 between the pubic bone 27 and the pubic bone 26 in a three-dimensional radial manner toward the bladder 25 side. The ultrasonic wave 24 emitted from the twelve sensors 22 [(1) to (12)] captures the shape change including the upper part of the bladder that is greatly expanded in a dome shape from the bottom of the bladder. Thereby, a polyurine amount of about 500 cc can be measured (estimated) with high accuracy.

  According to the non-invasive urine volume estimation apparatus 30 according to the present embodiment, the sensor group 23 is configured as follows. That is, the number of sensors is concentrated on the bottom side, the shape of the bladder bottom is captured by the fourth sensor row 224 on the bottom side, and the dome shape of the bladder is formed by the other first to third sensor rows 221 to 223. It was set as the structure which catches the height which swells. With such a sensor group 23, it is possible to efficiently capture a change in the three-dimensional shape when the bladder 25 is expanded and contracted, and to capture the shape of the bottom of the bladder more precisely. Therefore, it becomes possible to measure the amount of residual urine of 50 cc or less which has not been obtained conventionally. In the non-invasive urine volume estimation apparatus 30 of the present embodiment, the bladder capacity, that is, the urine accumulation volume, can be continuously measured with high accuracy over a wide range from about 50 cc to about 500 cc. Measurement values are unlikely to vary due to measurement conditions such as patient posture. The noninvasive urine volume estimation device 30 can be configured to be small and light, and is excellent in portability. Urine volume can also be measured in real time.

  The present invention can realize a urination management system that automatically records diagnosis information and urination diary from urination information obtained by using the above-described non-invasive urine volume estimation device 30 to manage urine accumulation / urination of patients. . Patient diagnosis information includes information such as maximum urine flow rate, residual urine volume, and urine flow rate curve. The patient's urination diary is information such as the number of urinations, the amount of urination, and the time of urination. These pieces of information are the most basic information (data) related to diagnosis / treatment of patients with dysuria, and are required to be accurately grasped.

  As shown in FIG. 11, the urination management system 51 according to the present invention analyzes the urination data recording device 52 and the urination data 54 from the urination data recording device 52, and manages urine management of patients such as diagnostic information and urination diary. A urination data analyzer 53 for obtaining data is provided. The urination data recording device 52 includes a non-invasive urine volume estimation device 30, a clock device 60, a data processing device 61 that processes measurement data from the non-invasive urine volume estimation device 30, and a data storage device 62. The urination data recording device 52 includes, for example, a microcomputer 63 having a clock function, a data processing function, and a data storage function and a non-invasive urine volume estimation device 30, and is configured as a small, light, and portable device. The urination data analysis device has a urine flow curve data acquisition function that can acquire urine flow curve data by continuous measurement based on time-series data sent to the data processing device. In addition, it has a residual urine volume measuring function for acquiring the residual urine volume obtained by ensuring the accuracy of a small amount.

  The urine data recording device 52 including the non-invasive urine volume estimation device 30 including the sensor unit 21 and the processing unit 31 and the microcomputer 63 having the above-described function is provided for the care of the patient's house or the patient as needed. Loaned to facilities, such as hospitals where patients are hospitalized. The urination data analysis device 53 is installed in a management center or the like that manages urination data such as a hospital or the like.

  In the urination management system 51 according to the present invention, urination information (so-called urination data) such as urination time and urine volume of a patient is recorded by using a rented urine data recording device 52. The urination data 54 held in the data holding device 62 or the data holding function of the microcomputer is sent to the urine data analyzing device 53 by, for example, wireless or USB memory. In the urination data analysis device 53, the sent urination data 54 is analyzed by a programmed personal computer to obtain diagnostic information such as the maximum urine flow rate, the residual urine amount, the urine flow curve, and the urination time required for urination. The diagnosis information includes the urine flow rate curve data obtained by analyzing the urination information sent from the urination data recording device and the residual urine amount obtained by ensuring the accuracy when the amount is small. At the same time, a urination diary having items such as urination frequency, urination volume, urination time (date) is obtained. In the urination data analysis device 53, high-quality urine management information necessary for urine management (that is, diagnosis / treatment) of these patients is obtained, and at the same time, the urine management information is stored.

  The patient's attending physician can obtain the patient's urine management information 64 from the urination data analyzer 53 and use it for diagnosis / treatment of the patient.

  FIG. 13 shows the actual urine storage amount and the estimated urine storage amount estimated using the noninvasive urine volume estimation device 30 of the present embodiment. The actual accumulated urine volume is the amount of residual urine when the amount of residual urine is subtracted from the final urine volume of the actual urine volume data measured by the urine flow measurement device and residual urine is confirmed by an ultrasound diagnostic device Is obtained by adding. That is, it shows the actual amount of accumulated urine during urination of the bladder. The marker a indicates the actual urine storage amount when there is no residual urine, and the marker b indicates the estimated urine storage amount corrected in consideration of individual differences in the calculated data. It can be seen from FIG. 12 that the tendency of the change in the amount of urine storage with respect to time coincides with both the marker curves a and b.

FIG. 12 shows the relationship between the actual urine output and the urine flow rate. A curve c indicates the actual urination volume, and a curve d indicates the urine flow rate. The actual urine output (curve c) is obtained by measuring the actual urine output every second with a urine flow measuring device. The urine flow rate (curve d) is calculated from the actual urine output data per second measured by the urine flow rate measuring device,
(Urine flow rate) = (Actual urine output at that time)-(Actual urine output after 1 second)
Is obtained by moving average processing.
As described with reference to FIG. 13, the tendency of the estimated urine accumulation amount obtained by the noninvasive urine volume estimation device 30 of the present embodiment and the actual urine accumulation amount measured by the urine flow rate measurement device coincide. From this, by using the non-invasive urine volume estimation device 30 of the present embodiment, the same urinary flow measurement urophrometry test, that is, important urine flow curve, urine output volume, residual urine volume data, for example, It can be obtained without giving a mood burden to the subject in the bathroom at home.

According to the urination management system 51 according to the present embodiment, useful urine management information such as diagnosis information and urination diary of patients in facilities such as home medical care or nursing care facilities and hospitals can be easily and without burden. Can be created. Then, the patient's attending physician can manage the patient's urine accumulation / urination based on the urine management information. This will lead to an improvement in the treatment of dysuria and contribute to improving the quality of life (QOL) of patients,
It will be useful for the medical economy, such as reducing diaper costs.

  The above-described non-invasive urine volume estimation device 30 senses in advance the amount of accumulated urine stored in the bladder for patients with dysuria or urinary incontinence, and informs the person, caregiver, nursing room, etc. to urinate Is also applicable. In this case, in the processing unit of FIG. 8, the urine volume estimation unit, that is, the urine volume estimation circuit 33 includes a determination circuit that determines whether or not urination is necessary. A reporting means for notifying the necessity of urination is connected to the subsequent stage of the urine volume estimation circuit 33 in accordance with the urine accumulation volume. The notification means can be constituted by alarm means (including sound), light, vibration, etc., or lamp display means. When the urine volume reaches a dangerous value in the urine volume estimation circuit 33, the patient or the caregiver or the nursing room can be notified through the notification means to prevent urination disorders including incontinence.

  Next, a bladder volume calculation method capable of estimating the urine accumulation amount more simply and accurately will be described.

  In general, in order to measure the amount of urine in the bladder, examination using a urinary catheter or ultrasound is performed. In particular, the transabdominal ultrasonic method using ultrasonic waves is widely used in the medical field as a non-invasive method. However, most of them are B-mode methods using an ultrasonic diagnostic apparatus, and in order to increase the calculation accuracy, it is necessary to observe the shape of an individual's bladder and give different correction coefficients to each. Also, it is difficult for patients and caregivers to easily measure urine volume in the bladder at home and manage urination.

  On the other hand, in the example of the urine volume estimation unit 33 of FIG. 8 using the sensor unit 21 described above, the bladder shape is measured by the A mode method, and urination management is performed. The bladder volume calculation method at this time calculates the volume by integrating the distance between the front wall and the rear wall of the bladder obtained from each sensor 22 to estimate the urine volume, and sets a correction coefficient for each individual. There is a need.

  The bladder volume calculation method according to the present invention efficiently obtains bladder shape information from a small number of sensors (ultrasound transducers) by the A-mode method, corresponds to changes in the shape of the bladder, and has a correction coefficient for each individual. This is a method for calculating the volume of the bladder without setting. This bladder volume calculation method is a truncated cone approximation method that estimates the volume by approximating the bladder to a set of truncated cones. In other words, in the bladder volume calculation method, when the triangular sensor unit 21 is used, the reference cross-sectional area of the bladder is measured using the five sensors 22 arranged on the bottom thereof, and the other seven sensors 22 are measured. The height and depth of the bladder are measured from information including, and the volume is estimated by approximating a set of truncated cones. The reference cross-sectional area of the bladder is the horizontal cross-sectional area of the bladder at a position corresponding to the upper pubic bone, and is measured from the information of the five sensors on the bottom side.

  This will be described in detail below. The bladder expands by pushing up the peritoneum as the amount of stored urine increases. Incidentally, when measuring the amount of residual urine, the most widely used is the transabdominal ultrasonic method. In the transabdominal ultrasound method, an ultrasonic probe is applied to the lower abdomen, and two types of B-mode images, a horizontal section and a sagittal section, are acquired from the gap between the peritoneum and the pubic bone. From the major axis W in the horizontal section, the head-tail diameter H in the sagittal section, and the ventral dorsal diameter D in the sagittal section, the bladder is approximated to an elliptical sphere and is calculated by Equation 3 (see FIGS. 14A and B).

However, in this method, an error of about 18% occurs due to deformation of the bladder and the like.

  In contrast, the bladder volume calculation method according to the present invention estimates the bladder volume by A-mode measurement. FIG. 15 shows an A-mode waveform of the bladder acquired by a sensor (ultrasonic transducer). In the present invention, a reception waveform (A mode waveform) as illustrated is obtained from each sensor, and the front wall position and the rear wall position of the bladder are measured. We propose a truncated cone approximation method that estimates the volume of the bladder by approximating the bladder to a set of truncated cones from the obtained bladder information.

  In order to calculate the volume of each truncated cone, as shown in Equation 4, the area and the height of each bottom surface and top surface are required.

In order to obtain the areas of the bottom surface and the top surface, as shown in FIG. 16A, the area S ₀ is approximated to a triangle overlap from bladder wall information obtained by a plurality of sensors 72 arranged horizontally in the sensor unit 71. Ask. Further, in order to obtain the height, as shown in FIG. 16B, each height Δh of the bladder is obtained by the sensor 72 positioned vertically. For example, when ultrasonic waves from a plurality of sensors 72 vertically positioned oscillate in parallel as shown in FIG. 16B, the bladder height Δh is obtained from the interval between the plurality of sensors 72 positioned vertically. In addition, to measure the depth D _i at the height of each. Here, in order to calculate the area of each bottom surface and top surface with a small number of sensors, as shown in FIG. 17, the horizontal cross-sectional area of one reference surface and the depth at the height from each reference surface are used. Then, the calculation is performed using Equation 5. In FIG. 16A and B, 73 shows a bladder and 74 shows a pubic bone.

Further, as shown in FIG. 17, regarding the bladder volume outside the sensor 72 and not observable, the upper bladder 73A is assumed to be a cone, and the bladder bottom 73B hidden by the pubic bone is assumed to be a hemisphere. Then, the volume of the bladder part 73C, the bladder upper part 73A, and the bladder bottom part 73B of each of these truncated cones is integrated, and the entire bladder volume V _cal is calculated by Equation 6. 73 shows the whole bladder.

Next, the reason why the horizontal cross-sectional area of the bladder at the position corresponding to the upper pubic bone is set as the reference plane will be described. When the frustoconical approximation method is used, the horizontal cross-sectional area of each bladder is estimated from the ratio of the depths at the respective bladder heights according to Equation 5, and therefore the height of the horizontal cross-section of the bladder is the reference. In order to obtain the horizontal cross-sectional area S ₀ as a reference plane, examination using a CT image was performed.

FIG. 18 shows an abdominal CT image of a male patient (patient A). Reference numeral 73 denotes a bladder. A horizontal section of the bladder 73 was observed at intervals of 6 mm from the bladder bottom (f) 0 mm to the upper bladder (a) 30 mm in the pelvis. The shape of the horizontal section of the bladder 73 expands mainly so as to protrude to the abdomen while gradually changing. After reaching the maximum area at the bladder middle part (c) 18 mm, the bladder 73 slightly contracts to the upper part of the bladder (a). Has reached. From this CT image, the reference area and the depth in each horizontal section are measured using image analysis software Scion-image and compared with the actual bladder volume. As a reference horizontal section, 2 of the horizontal section S _public (e) of the upper pubic bone considered to have little influence of the peritoneum, the body position, etc., and the maximum horizontal section S _max (c) used in the transabdominal ultrasonic method or the like For each type, each bladder volume V _cal is calculated and compared with the actual volume V _true .

Table 1 shows the calculation results. In addition to the male patient (patient A), the bladder volume was calculated in the same manner for the female patient (patient B). In either case, the error was smaller when the horizontal section S _{public of the} upper pubic bone was _used as a reference. In the present invention, from the result of Table 1, the horizontal section S _{public of the} upper pubic bone is _used as the reference plane.

Next, the validity of the bladder volume calculation method by the truncated cone approximation method of the present invention will be verified. In order to confirm the validity of this method, we performed verification using echo images. With respect to bladders of different urine volume of healthy subjects, horizontal cross-sectional echo images at different heights of the bladder are taken using an ultrasonic diagnostic apparatus, and the horizontal cross-section S _public above the pubic bone and The bladder volume was calculated by applying this method based on two horizontal cross sections _Smax .

  Nineteen urinary bladders with different amounts from 81 ml to 454 ml were measured, and about 6 to 12 echo images were acquired for one bladder. The subject urinated within 5 minutes after acquiring the echo image in the supine position, and the amount of urination was measured. After urination, a residual urine test is performed again with an ultrasonic diagnostic apparatus to confirm that there is no residual urine. The measured amount of urination is approximately equal to the actual volume of the bladder in the captured echo image.

FIG. 19 shows the actual volume V _{true of} the bladder, the bladder volume V _public calculated on the basis of the upper pubic bone, and the bladder volume V _max calculated on the basis of the maximum horizontal section. The solid line in the figure is a straight line where the actual volume and the calculated volume coincide. ♦ indicates V _public , and ◇ indicates V _max . FIG. 19 shows that the actual volume and the calculated volume are in good agreement. That is, this bladder volume calculation method that approximates the bladder to a truncated cone suggests that the bladder volume can be estimated with high accuracy. When the horizontal section of the upper pubic bone is used as a reference (♦ mark), the accuracy is even better.

  Table 2 shows the respective average absolute errors and standard deviations. The error rate is 10.1% when the maximum horizontal section is used as a reference, while the error rate is 10.1% when the horizontal section of the upper pubis is used as a reference. That is, even in the examination using the echo image, when applying this bladder volume calculation method, it can be confirmed that accurate volume calculation can be performed by using the horizontal section of the upper pubic bone as a reference.

  In the present invention, the sensor unit 21 shown in FIG. 1 with a small number of sensors can be used as a sensor unit to which the present bladder volume calculation method is applied. 20 and 21 show a specific example in which the angles θ1 and θ2 of the sensor unit 21 to which the present bladder volume calculation method is applied, in particular, an example of an ultrasonic trajectory oscillated from each sensor 22. As shown in FIG. 1 described above, the sensor unit 21 is arranged so that the sensors 22 (1) to 22 (12) using 12 ultrasonic transducers form a triangular shape. The sensors 22 (1) to 22 (12) are arranged with different angles θ1 and θ2. 25 indicates the bladder, 26 indicates the pubic bone, and 27 indicates the peritoneum.

  Regarding θ1, the sensors 22 (8) and 22 (12) are 7.5 °, the sensors 22 (9) and 22 (11) are 5 °, and the sensors 22 (6) and 22 (10) are 0 °. Further, the sensors 22 (5) and 22 (7) are 5 °, the sensors 22 (4) and 22 (3) are 7.5 °, and the sensors 22 (1) and 22 (2) are 7.5 °.

  Regarding θ2, sensor 22 (1) is 5 °, sensor 22 (2) is 10 °, sensor 22 (3) is 5 °, and sensor 22 (4) is 12.5 °. Sensors 22 (5) to 22 (7) are 10 °, and sensors 22 (8) to 22 (12) are 5 °.

  Note that the angles θ1 and θ2 of each sensor 22 shown in FIGS. 20 and 21 are only specific examples, and the maximum of θ1 is about 12.5 ° and the maximum of θ2 is about 10 °. It can be appropriately changed according to the design of the sensor unit. Also, the number and arrangement of the sensors 22 of the sensor unit 21 in FIG. 1 can be changed as appropriate according to the design of the sensor unit, as will be described later.

  The frequency of the sensors 22 (1) to 22 (12) was 3 MHz, and the diameter was 10 mm. The sensor unit 21 is connected to the drive driver, and sequentially applies pulse signals to the 12 sensors 22 by the drive driver to transmit ultrasonic waves, and stores the energy level of the reflected wave received by the same sensor 22. Five sensors 22 (8) to 22 (12) arranged in a horizontal row at the bottom of the triangular shape oscillate and receive ultrasonic waves radially and capture a horizontal section of the bladder at a position corresponding to the upper pubic bone. . The sensors 22 (1) to 22 (7) are arranged vertically with different angles θ2 in the height direction, and capture the bladder height information and the depth information at each height. The sensors 22 (5) to 22 (7) are the lowest sensors when the bottom five sensors 22 (8) to 22 (12) cannot capture the horizontal cross section due to a large deformation of the bladder rear wall. It is also used as a sensor for capturing the horizontal cross-sectional area at an angle different from that of the lower sensors 22 (8) to 22 (12). These sensors 22 allow for a frustoconical approximation of the bladder.

The height Δh of each truncated cone when capturing the bladder volume as a set of each truncated cone volume is the bladder heights h _i , h _{i + 1} , h _{i + 2} , h _{i + 3} ,. Defined by height difference. That is, each Δh is (h _{i + 1} ) − (h _i ) = Δh, (h _{i + 2} ) − (h _{i + 1} ) = Δh, (h _{i + 3} ) − (h _{i + 2} ) = Δh,.

  Here, each height Δh of the bladder (corresponding to Δh in Expression 4) can be defined as follows as an example. As shown in FIG. 21, first, an ultrasonic trajectory that oscillates at an angle of 5 ° from the fourth-stage sensor 22 [(8) to (12)] and crosses the bladder 25 across the front wall and the rear wall is a reference line. And Next, for example, an ultrasonic trajectory that crosses the front wall and the rear wall of the bladder 25 oscillated at an angle of 10 ° from the sensor 22 [(5) to (7)] and the intersection point of the rear wall of the bladder 25 is a reference. Then, an extension line extending from the intersection at an angle of 5 ° parallel to the reference line is obtained. The height between the extension line and the reference line is Δh. Similarly, this intersection point is based on the intersection of the trajectory of the ultrasonic wave that oscillates from the sensor 22 (4) at an angle of 12.5 ° and crosses the bladder 25 across the front and rear walls and the rear wall of the bladder 25. To obtain a line extending at an angle of 5 ° parallel to the reference line. Similarly, a line by an ultrasonic trajectory that is oscillated from the sensor 22 (3) at an angle of 5 ° and crosses the bladder 25 across the front wall and the rear wall is obtained. This line is parallel to the reference line. Similarly, with reference to the intersection of the ultrasound trajectory that oscillates at an angle of 10 ° from the sensor 22 (2) and crosses the bladder 25 across the front and rear walls, and the rear wall of the bladder 25, from this intersection, A line extending at an angle of 5 ° parallel to the reference line is obtained. Similarly, a line by an ultrasonic trajectory that oscillates at an angle of 5 ° from the sensor 22 (1) and crosses the bladder 25 across the front wall and the rear wall is obtained. This line is parallel to the reference line. Each height Δh of the urinary bladder is obtained by using the ultrasonic trajectory from the lowermost sensor as a reference line, and the mutual relationship between this reference line and each line parallel to the reference line obtained by ultrasonic waves from each sensor arranged in the vertical direction. Is defined by the interval between adjacent lines.

  In addition to the above example, the method of setting each height Δh of the bladder is based on, for example, the intersection of the ultrasonic wave and the anterior bladder wall, and an extension line parallel to the reference line is obtained from this intersection. Various setting methods such as a setting method can be considered. This Δh is obtained at least based on the ultrasonic waves from the sensors 22 having different angles.

  The clinical utility of the bladder volume calculation method of the present invention was verified. In the verification, 61 cases of bladders of 9 healthy persons (5 men and 4 women) were measured by the sensor unit 21 of FIGS. 20 and 21, and the bladder volume was calculated by the truncated cone approximation method. The sensor unit 21 was applied with echo gel as an acoustic binder, and the sensor unit 21 was mounted on the abdomen of the subject in the supine position so that the bottom side of the triangle could capture the bladder 25 from above the pubic bone 26. FIG. 22 shows received waveforms (A mode waveforms) obtained by all 12 sensors 22 of the sensor unit 21.

  The bladder volume is calculated from the bladder wall information obtained from this received waveform. Further, in order to compare and verify with the calculated bladder volume, the urine flow measurement device was urinated within 5 minutes after measurement by the sensor unit 21, and the actual urine output was measured. Thereafter, it was confirmed by an ultrasonic diagnostic apparatus that there was no residual urine. That is, the actual urine output is substantially equal to the actual urine volume in the bladder immediately before urination. FIG. 23 shows the actual urine volume in the bladder and the estimated urine volume by calculating the bladder volume from the received waveform of the sensor unit 21 by the truncated cone approximation method. In the measured actual urine volume range of 44 ml to 506 ml, the actual urine volume and the estimated urine volume were in good agreement, and the correlation coefficient γ was 0.96.

  For bladders with an actual urine volume of 44 to 506 ml, the average absolute error from the urine volume estimation obtained by the truncated cone approximation method was 14%, and the standard deviation was 20.8. As a result, the usefulness of this bladder volume calculation method was confirmed.

  The bladder volume calculation method based on the above-described frustoconical approximation method is valid regardless of the total number of sensors of the sensor unit and the number of arrangement of each stage. The number of sensors of the sensor unit to which this method is applied is not limited to twelve, and can be appropriately set as necessary. As a shape of the sensor unit, an inverted T-shape in which sensors are arranged in the X direction (bottom side portion) capturing the bladder bottom shape and the Y direction capturing the top portion can be used.

  Next, another embodiment of the non-invasive urine volume estimation apparatus according to the present invention using the above-described bladder volume calculation method will be described. In the present embodiment, the sensor unit 21 shown in FIG. 1 is used as the sensor unit. The non-invasive urine volume estimation device according to the present embodiment detects and calculates reflected ultrasonic waves from the bladder wall of ultrasonic waves oscillated from each sensor of the sensor unit 21 and the sensor group of the sensor unit 21. And a processing unit for obtaining a bladder volume and estimating a urine volume. Although not shown in the figure, this processing unit is based on a reception waveform that is position information of the front wall and the rear wall of the bladder, which is received by each sensor 22 [(1) to (12)] of the sensor unit 21, that is, an A mode waveform. An arithmetic unit for calculating the bladder volume by the truncated cone approximation method is provided.

In this calculation unit, the following calculation (calculation) is performed. Measuring the depth D _i of the bladder in the bladder height by A mode of the received waveform with a plurality of sensors 22 in the longitudinal direction of the sensor line of each stage 221 to 224 of the sensor unit 21. Each bladder height corresponds to each bladder height from the reference plane below. The horizontal cross-sectional area S _{0 serving} as the reference plane of the bladder and the depth D ₀ of the bladder at the reference plane are measured by the five lowest sensors 22 [(8) to (12)] corresponding to the pubic bone. Using the horizontal cross-sectional area S ₀ of the reference plane and the depth D _i at each bladder height, the horizontal cross-sectional area S _i of the bladder at each bladder height position is calculated by the above [Equation 5]. The frustoconical volume Vi of each bladder cut at each height Δh defined by the difference in each bladder height is calculated from the above-mentioned [Equation 4] from the horizontal sectional areas Si and Si + 1 of the bottom and top surfaces and the height Δh. Calculate according to. The bottom of the bladder hidden by the pubic bone is estimated as a hemispherical volume, the top of the bladder is estimated as a conical volume, and the hemispherical volume and the conical volume are calculated and obtained. Then, the total bladder volume is calculated by integrating the respective truncated cone volumes, hemispherical volumes, and conical volumes.
According to the non-invasive urine volume estimation device according to the present embodiment, by providing a processing unit that obtains the bladder volume by the truncated cone approximation method and estimates the urine volume, it covers a wide range from a small urine volume to a large urine volume. The urine volume close to the actual urine volume can be estimated with higher accuracy.

  Next, another embodiment of the urination management system according to the present invention provided with a non-invasive urine volume estimation device to which the bladder volume calculation method is applied will be described. As in the block configuration of FIG. 11, the urination management system is a non-invasive urine volume estimation device to which the above-described bladder volume calculation method is applied, and data that processes and stores measurement data from the non-invasive urine volume estimation device. A urination data recording device having a processing / data storage device is provided. Further, the urination management system analyzes the urination information including the urination time and the amount of urination sent from the urination data recording device, and obtains and stores the urine management information including the diagnostic information and the urination diary. Is provided. The non-invasive urine volume estimation device includes the sensor unit 21 and the processing unit described above. The urination data recording device also has a clock device.

As described above, the diagnostic information includes the urine flow rate curve data obtained by analyzing the urination information sent from the urination data recording device, the residual urine volume obtained by ensuring the accuracy at the time of small quantity, the maximum Including urine flow rate and urination time required for urination. The urination diary has items such as urination frequency, urination volume, urination time (date and time), etc. The urination data analyzer can obtain urine flow rate curve data by continuous measurement from time-series data sent to the data processor It has a curve data acquisition function. In addition, it has a residual urine volume measuring function for acquiring the residual urine volume obtained by ensuring the accuracy of a small amount.

  In the urination management system, the urine accumulation / urination management of the patient is performed based on the urination management information from the urination data analysis apparatus in the same manner as described with reference to FIG.

  According to the urination management system according to the present embodiment, the urine management system includes a processing unit that calculates the urinary volume by obtaining the bladder volume by the truncated cone approximation method, and can calculate more accurate urine management information. Practical use of patient urine storage / urination management can be achieved.

  By applying the non-invasive urine volume estimation device that estimates the bladder volume by the frustoconical approximation method described above, it is possible to easily create an automatic record of urination diary with useful information at home and without burden on the patient. It becomes possible. This bladder volume calculation method can promote further practical use of the urination management system described above.

  21 .. Non-invasive urine volume estimation sensor unit, 22 .. Sensor, 23 .. Sensor group, 24 .. Ultrasound, 25. Bladder, 26 .. Pubic bone, 27 .. Peritoneum, 28 .. Gap, 30 .. Non-invasive urine volume estimation sensor unit device, 31 ... Processing unit, 32 ... Bladder shape measuring unit, 33 ... Urine volume estimation unit, 45 ... Transmission control unit, 46 ... Signal processing unit, 51 ... Multiplexer, 52 .. Ultrasonic transmission amplifier, 53 .. Ultrasonic reception amplifier, 54 .. Pulse transmission circuit, 55 .. Pulse control circuit, 56 .. Signal processing circuit

Claims (11)

A non-invasive urine volume estimation sensor unit comprising a plurality of sensors using ultrasonic transducers, and having a sensor group in which each sensor can detect a bladder shape and an ultrasonic wave output angle. The sensor group is:
A first sensor unit including a plurality of sensors that emit ultrasonic waves with a two-dimensional spread and detect the shape of the bladder bottom;
The non-invasive urine volume estimation sensor unit according to claim 1, further comprising: a second sensor unit that is emitted with a three-dimensional spread and includes a plurality of sensors that detect an expanded height of the bladder. The noninvasive urine volume estimation sensor unit according to claim 2, wherein an ultrasonic wave emission surface of a part of the sensors in the first sensor unit is inclined at a required angle with respect to a two-dimensional spreading surface. The sensor group is:
4. A plurality of sensors by ultrasonic transducers are two-dimensionally arranged so that the number of sensors emitted to the bottom of the bladder is maximized and a plurality of sensor rows are arranged from the bottom side toward the top. The non-invasive urine volume estimation sensor unit described. By the ultrasonic wave emitted from each sensor in the sensor line on the bottom side, mainly catch the shape change on the bladder bottom side,
The noninvasive urine volume estimation sensor unit according to claim 4, wherein the height of bladder expansion is mainly captured by ultrasonic waves emitted from sensors in other sensor rows excluding the sensor row on the bottom side. A non-invasive urine volume estimation sensor unit according to any one of claims 1 to 5,
A processing unit that detects the reflected ultrasonic waves from the bladder wall of the ultrasonic waves oscillated from each sensor of the sensor group of the non-invasive urine volume estimation sensor unit, calculates the three-dimensional shape of the bladder, and estimates the urine volume And a non-invasive urine volume estimation device. The processor is
A transmission control unit that sequentially transmits each sensor of the sensor group;
A signal processing unit that receives ultrasonic waves reflected by the front wall and the rear wall of the bladder by the sensor, calculates a position of the front wall and the rear wall of the bladder from the obtained reception signal, and measures a three-dimensional shape of the bladder;
The non-invasive urine volume estimation device according to claim 6, further comprising: a urine volume estimation unit that estimates a urine volume from a three-dimensional shape of the bladder obtained by the signal processing unit. A non-invasive urine volume estimation sensor unit according to any one of claims 1 to 5,
A processing unit that detects the reflected ultrasonic waves from the bladder wall of the ultrasonic waves oscillated from each sensor of the sensor group of the non-invasive urine volume estimation sensor unit, calculates the three-dimensional shape of the bladder, and estimates the urine volume A non-invasive urine volume estimation device,
A urination data recording device having a data processing / data storage device for processing and storing measurement data from the non-invasive urine volume estimation device;
Analyzing urination information including urination time and urination volume sent from the urination data recording device, and diagnostic information including urine flow rate curve data by continuous measurement and residual urine volume obtained by ensuring accuracy at a small amount; A urine data analysis device for obtaining and storing urine management information including a urination diary,
A urination management system for managing urine accumulation / urination based on the urine management information. The processor is
A transmission control unit that sequentially transmits each sensor of the sensor group;
A signal processing unit that receives ultrasonic waves reflected by the front wall and the rear wall of the bladder by the sensor, calculates a position of the front wall and the rear wall of the bladder from a time difference of the obtained reception signals, and measures a three-dimensional shape of the bladder; ,
A urine volume estimation unit that estimates the urine volume from the three-dimensional shape of the bladder obtained by the signal processing unit,
The urination management system according to claim 8, wherein urination information including urination time and urination volume is obtained through the urine volume estimation unit. Non-invasive urine volume estimation sensor unit according to claim 4,
A processing unit for detecting reflected ultrasound from the bladder wall of the ultrasonic wave oscillated from each sensor of the sensor group of the non-invasive urine volume estimation sensor unit, calculating the bladder volume, and estimating the urine volume. ,
In the processing unit, based on the A-mode waveform that is position information of the anteroposterior wall of the bladder received by each sensor, the processing unit has a calculation unit that calculates the bladder volume by a truncated cone approximation method,
In the calculation unit,
The longitudinal direction of the reception waveform of the A mode at a plurality of sensors with a longitudinal direction at different angles, which are arranged on the sensor line in each stage to measure the depth D _i of the bladder in the bladder height obtained from each sensor ,
Measuring the depth D ₀ of the bladder in the horizontal cross-sectional area S ₀ and the reference surface as a reference surface of the bladder by a plurality of sensors lowermost corresponding to suprapubic, in horizontal cross-sectional area S ₀ and the reference plane of the reference surface Using the depth D ₀ and the depth D _i at each bladder height to calculate the horizontal cross-sectional area S _i of the bladder at each bladder height position by calculation according to Equation 7,
The frustoconical volume V _i of each bladder cut at each height Δh defined by the difference in each bladder height is expressed by the following equation (8) from the horizontal cross-sectional areas S _i and S _{i + 1} of the respective bottom and top surfaces and the height Δh. Calculate to find
The bladder bottom hidden in the pubic bone is estimated as hemispherical volume, the bladder top is estimated as conical volume,
A noninvasive urine volume estimation device that calculates the total bladder volume by integrating the respective truncated cone volumes, the hemispherical volume, and the conical volume. The non-invasive urine volume estimation device according to claim 10,
A urination data recording device having a data processing / data storage device for processing and storing measurement data from the non-invasive urine volume estimation device;
Analyzing urination information including urination time and urination volume sent from the urination data recording device, and diagnostic information including urine flow rate curve data by continuous measurement and residual urine volume obtained by ensuring accuracy at a small amount; A urine data analysis device for obtaining and storing urine management information including a urination diary,
A urination management system for managing urine accumulation / urination based on the urine management information.