JP7227040B2 - Measuring device, flow path, measuring tape, and measuring method - Google Patents

Description

TECHNICAL FIELD The present disclosure relates to a measuring device, a channel, a measuring tape, and a measuring method for measuring properties of a liquid.

Conventionally, there has been known a flow cell in which a sample solution is passed through a hollow chamber having a square channel cross section, a focused laser beam is irradiated thereon, and scattered light emitted from the sample is detected. As one type of flow cell, there is known a flow cell including a sample-nonaffinity substrate and a channel of a porous member provided on the sample-nonaffinity substrate. In this flow cell, the porous member is composed of a sample-affinity non-contact region having a mesh structure, and an air-contacting region covering the non-contacting region and having a lower pore density than the non-contacting region. Capillary force generated in the porous member serves as a driving force for liquid transfer (see Patent Document 1).

WO2008/001737

In the measurement using the flow cell of Patent Document 1, there is a limit to the measurement range of the substance to be measured, and it is difficult to measure highly concentrated substances exceeding the measurement range with high accuracy.

The present disclosure has been made in view of the above circumstances. , and methods of measurement.

One aspect of the present disclosure is a mixture of a first porous membrane into which body fluid is introduced, a polymer fixed to the first porous membrane and soluble in the body fluid, and the polymer dissolved in the body fluid. A measuring device comprising: a reagent that reacts with a generated mixed solution; and a measuring unit that measures characteristics of the mixed solution that has reacted with the reagent.

One aspect of the present disclosure is a channel for feeding bodily fluid, wherein at least part of the channel has a plurality of first through holes for maintaining the pressure in the channel at atmospheric pressure. a second region having an affinity for the bodily fluid; the first porous membrane disposed between the first region and the second region and having an affinity for the bodily fluid; a second porous membrane disposed between the first region and the second region; a polymer fixed to the first porous membrane and soluble in the bodily fluid; and the polymer dissolved in the bodily fluid. a reagent that reacts with the mixed liquid produced by mixing, a space is defined between the first porous membrane and the second porous membrane, and the bodily fluid is in the second region; It is a flow path through which the liquid is sent from the second porous membrane to the first porous membrane by a force caused by the affinity with.

One aspect of the present disclosure is a measurement tape including the above flow path, wherein the flow path is adjacent to the third porous film forming the first region, the third porous film, and the A first sheet forming part of the second region and a second sheet forming the other part of the second region, wherein the third porous film, the first sheet and the second sheet are and a measuring tape having flexibility capable of bending in an arrangement direction in which the third porous membrane and the second sheet are arranged.

In one aspect of the present disclosure, a step of introducing body fluid into a porous membrane, a step of reacting the body fluid with a polymer soluble and fixed to the porous membrane to dissolve the polymer, and a step of dissolving the body fluid and A measurement method comprising the steps of: mixing the polymer with the polymer to generate a mixed solution; reacting the mixed solution with a reagent; and measuring properties of the mixed solution that has reacted with the reagent. .

According to the present disclosure, it is possible to measure the substance to be measured with high accuracy by expanding the measurement range of the substance to be measured contained in body fluid.

1 is a diagram showing a schematic configuration of a drain management system according to an embodiment; FIG. Diagram showing the internal configuration of the drain sensor Block diagram showing the circuit configuration of the sensor unit Diagram showing the shape of the drain bag Partially broken perspective view showing the appearance of the drain monitor Diagram for explaining the operation of the drainage sampling mechanism Flowchart showing the operation procedure for drain sampling FIG. 2 is an exploded perspective view showing an example of flow paths formed in the measurement tape; A plan view showing an example of an adhesive layer in a channel Cross-sectional view showing an example of a flow path Cross-sectional view showing an example of introduction of a sampling liquid in a channel Cross-sectional view showing an example of the flow of the sampling liquid separated by the blood cell separation membrane in the channel A cross-sectional view showing an example of the sampling liquid reaching the porous membrane to which the liquid is sent in the channel. Conceptual diagram showing an example of a process in which a mixed liquid is generated in a porous membrane A diagram showing an example of a calibration curve based on each sample point showing the relationship between the amount of change in absorbance and the concentration of amylase. Conceptual diagram showing an example of the process for measuring the properties of high-concentration amylase Flowchart showing the procedure for measuring amylase activity Diagram showing the drain monitor display Diagram explaining introduction of bodily fluid containing medicine etc. to a patient by a TCI pump A diagram for explaining variation in a specific range of the correspondence relationship between amylase absorbance and amylase concentration (0 to 5000 U/L) A diagram showing variations in the correspondence between the amount of change in absorbance of amylase and the concentration of amylase (0 to 70000 U/L).

Hereinafter, embodiments of a channel, a measuring tape, and a measuring device according to the present disclosure will be described with reference to the drawings.

(Circumstances leading to obtaining one form of the present disclosure)
FIG. 14 is a diagram for explaining variation in a specific range of the correspondence relationship between the amount of change in absorbance of amylase and the concentration of amylase. Graph g1 shows the measured absorbance of amylase over time. Graph g1 shows how the absorbance increases over time for each substance to be measured (for example, amylase). In other words, it indicates that the amount of change in the absorbance of amylase increases over time. Graph g2 shows the relationship between the amount of change in measured absorbance and the actual concentration of amylase. Graph g2 shows the range of amylase concentration (amylase activity) from 0 to 5000 U/L. In graph g2, the relationship between the amount of change in absorbance of amylase and the concentration of amylase fluctuates due to the influence of the bilirubin value in the sample from which amylase was collected (see circles in graph g2). In the embodiments, the concentration of amylase and the activity of amylase are used without particular distinction, but the concentration of amylase and the activity of amylase correspond to each other on a one-to-one basis.

FIG. 15 is a diagram showing variations in the correspondence relationship between the amount of change in absorbance of amylase and the concentration of amylase. FIG. 15 shows a wide amylase concentration range of 0 to 70000 U/L.

14 and 15, when the concentration of amylase is in the range of 0 to 2000 U/L, there is a high correlation between the amount of change in absorbance of amylase and the concentration of amylase, and the concentration of amylase is higher than 2000 U/L. It can be understood that the larger the value, the lower the correlation between the amount of change in absorbance of amylase and the concentration of amylase. That is, when the concentration of amylase is greater than 2000 U/L, the amount of change in absorbance of amylase reaches the upper limit, and it can be understood that the measurement accuracy of the concentration of amylase with respect to the amount of change in absorbance is greatly reduced.

In the following embodiments, a measuring device, a channel, a measuring tape, and a measuring method capable of expanding the measurement range of a substance to be measured contained in body fluid and measuring the substance to be measured with high accuracy will be described.

In the following embodiments, a drainage liquid management system is shown as an example of a drainage liquid management system. The drainage management system measures the characteristics of the components to be managed contained in the drainage fluid flowing through the drain tube for drainage connected to the patient's body, and performs various observations and evaluations of the characteristics of the drainage fluid.

Drainage is a liquid containing blood, exudate, etc. accumulated in the body, which is discharged to the outside of the body after surgery. Amylase, a digestive enzyme, and bilirubin, a bile pigment, may be released from the affected area after gastrointestinal surgery. These ingredients can damage organs and dissolve blood vessels, leading to bleeding and risk of complications. Therefore, measuring the characteristics of the controlled components contained in the drain fluid is a major index for medical professionals to consider the next medical practice. For example, amylase, bilirubin, and blood properties may be measured as controlled components in drain effluent.

(Configuration of drain management system)
FIG. 1 is a diagram showing a schematic configuration of a drain management system 5 according to an embodiment. The drain liquid management system 5 includes a non-contact drain liquid sensor 10 , a drain liquid monitor 20 , a drain tube 30 and a drain bag 40 . Drain effluent sensor 10 is used to measure properties of controlled components (eg, blood, amylase, bilirubin) in drain effluent flowing through transparent drain tube 30 . That is, the drain sensor 10 is an example of a measuring device. As a controlled component, amylase is a digestive enzyme secreted from the pancreas and salivary glands. Bilirubin is a yellow pigment contained in bile. Blood is bleeding from organs and blood vessels.

The drain liquid monitor 20 is connected to the drain liquid sensor 10 by wireless communication or wired communication, and records and displays the measurement results of the drain liquid sensor 10 . A display 21 for displaying various information is arranged on the front surface of the drain monitor 20 .

Drain tube 30 conducts drain effluent from the patient's body and flows to drain bag 40 . The drain tube 30 is molded from a translucent material such as a resin so that the user can visually observe the drain. One end of the drain tube 30 is connected (inserted) into the patient's body, and the other end of the drain tube 30 is connected to the drain bag 40 . The drain bag 40 stores the drain fluid flowing from the drain tube 30 .

The drain liquid stored in the drain bag 40 includes the discharge that has flowed in from the start of drainage to the time of measurement. Therefore, it is difficult to measure, using the drain effluent, the properties of the component to be managed in the drain effluent that fluctuate over time in association with time.

For this reason, the drain drainage management system 5 uses the drain drainage flowing through the drain tube 30 connected between the patient's body and the drain bag 40 to measure the properties of the components to be managed in the drain drainage. It was to be. This method allows the drain management system 5 to perform non-invasive measurements on the patient.

FIG. 2A is a diagram showing the internal configuration of the drain sensor 10. As shown in FIG. The drain fluid sensor 10 has, for example, a box-shaped housing 10z, and houses the fluid sampling mechanism 110 and the blood cell separation/enzyme reaction mechanism 150 inside the housing 10z.

In the drainage sampling mechanism 110, a main tube 130 (an example of a main flow path) is attached so as to pass through the inside of the housing 10z. In FIG. 2A, the main tube 130 is provided in the left-right direction. Both ends of the main tube 130 may protrude from through-holes 10y formed in both side surfaces of the housing 10z and may be connected to both ends of the drain tube 30 . Note that the main tube 130 may be part of the drain tube 30 .

A sub-tube 133 (an example of a sub-flow path) branching from the main tube 130 is connected to approximately the center of the main tube 130 . Here, the position of the main tube 130 to which one end of the subtube 133 is connected is also called a branch point. The subtube 133 has an elongated channel 133z that can communicate with the interior of the main tube 130 . The branch point may be a connection position between the sub-tube 133 and the channel 133z. The sub-tube 133 may be molded from a material having elasticity (rubber, resin, etc.), and may be a material that recovers elasticity. The sub-tube 133 is deformed within the range of elastic deformation and is not deformed within the range of plastic deformation. Elongated channel 133z is normally closed. Since the channel 133z is normally closed, the drain liquid Lq in the main tube 130 does not flow into the channel 133z of the subtube 133, and the liquid in the channel 133z of the subtube 133 flows into the main tube 130. There is no backflow to. Also, gas does not flow in from the opposite side of the sub-tube 133 to the main tube 130 side (lower side in FIG. 2A).

When viewed from the main tube 130 , the sub-tube 133 can also be said to be a protruding part formed to protrude in the middle of the main tube 130 . It can also be said that a notch is formed in this projecting portion as the flow path 133z.

The drainage sampling mechanism 110 has a main tube 130 and a sub-tube 133 as well as a pair of restricting members 113 and 114 and a first pressing member 115 .

The pair of restricting members 113 and 114 has partition plates 113B and 114B formed with curved ends, and pressure units 113A and 114A, respectively. The partition plates 113B and 114B driven by the pressurizing units 113A and 114A move so as to press the points (for example, two points) on both sides of the branch point of the main tube 130, respectively. A pair of restricting members 113 and 114 can press both sides of the main tube 130 across the branch point of the sub-tube 133 . The pair of restricting members 113 and 114 presses both sides of the main tube 130 substantially simultaneously, thereby restricting the drain liquid Lq to the main tube 130, for example, stopping it from flowing. Therefore, the drain liquid Lq stays in the pipe central portion 130c of the main tube 130 located near the branch point. The tube center portion 130c may be, for example, the area between the two points pressed by the restricting members 113,114.

The first pressing member 115 has a pressing plate 115B having a flat flat plate along the longitudinal direction of the main tube 130, and a pressing unit 115A. The pressing plate 115B driven by the pressing unit 115A moves so as to press the main tube . When the first pressing member 115 presses the main tube 130, the pressure of the drain liquid Lq staying in the central portion 130c of the main tube 130 blocked by the pair of restricting members 113 and 114 increases.

When the pressure of the drain liquid Lq in the pipe center portion 130c rises, the channel 133z of the sub-tube 133 opens, and the drain liquid Lq staying in the pipe center portion 130c flows into the channel 133z of the sub-tube 133. . The waste fluid that has flowed into the channel 133z of the subtube 133 flows out so as to be pushed out from the opposite end surface of the channel 133z. The drain liquid Lq flowing out from the opposite end surface of the channel 133z drips onto the channel 210 of the measuring tape 200 arranged to face the sub-tube 133 as the sampling liquid sq (see FIG. 7A). do.

Pressurization units 113A, 114A, and 115A (described later) move partition plates 113B, 114B and pressing plate 115B in forward and backward directions in accordance with drive signals from sensor unit 180, respectively. For example, when the pressurizing unit is composed of a motor gear mechanism, the partition plates 113B and 114B and the pressing plate 115B move linearly by driving the motor. Note that the pressurizing unit is not limited to the motor gear mechanism, and may be configured by an electromagnetic slide mechanism, a piezoelectric element, a hydraulic slide mechanism, or the like.

The blood cell separation/enzyme reaction mechanism 150 separates blood cells contained in the drain fluid Lq, reacts the enzyme with the reagent, and optically measures the absorbance of the enzyme. The blood cell separation/enzyme reaction mechanism 150 may optically measure the absorbance of components to be managed (for example, blood cells and bilirubin) other than enzymes. The blood cell separation/enzyme reaction mechanism 150 has a tape take-up mechanism 170 and a sensor unit 180 .

The tape take-up feed mechanism 170 includes the measurement tape 200 onto which the sampling liquid sq is dropped, the feed reel 171 around which the unused measurement tape 200 is wound, and the take-up reel around which the measurement tape 200 after the reaction is wound. 172. The tape take-up feed mechanism 170 also has a motor 175 that drives the take-up reel 172 and rollers 177 and 176 that guide the movement of the measurement tape 200 . The take-up reel 172 is driven by a motor 175 to rotate, and takes up the measuring tape 200 after the reaction. The feed reel 171 rotates along with the movement of the measuring tape 200 .

Here, the take-up reel 172 rotates so as to take up the measurement tape, but the take-up reel 172 and the feed reel 171 are driven by motors to wind and feed the measurement tape 200 at the same time. , and the movement of the measuring tape 200 can be stabilized. Alternatively, only the feed reel 171 may be driven by a motor, and the take-up reel 172 may be rotated together.

The sensor unit 180 is arranged so as to face the drainage sampling mechanism 110 with the measurement tape 200 interposed therebetween. The sensor unit 180 optically measures the absorbance of the enzyme contained in the sampling liquid sq2 (see FIG. 8C) permeating the measurement tape 200 fed by the tape winding and feeding mechanism 170 . In this measurement, the sensor unit 180 projects light having a peak value of a predetermined wavelength (for example, a wavelength of 405 nm) as measurement light toward the measurement tape 200 permeated with the sampling liquid sq2 containing a large amount of enzyme. The sensor unit 180 may receive scattered light that is not absorbed by the enzyme in the sampling liquid sq2, and measure the absorbance of the enzyme contained in the sampling liquid sq2 based on the amount of scattered light received.

FIG. 2B is a block diagram showing the circuit configuration of the sensor unit 180. As shown in FIG. The sensor unit 180 has a housing 180z in which a circuit board 188 is laid. The sensor unit 180 has a CPU (Central Processing Unit) 181 , an LED (Light Emitting Diode) 182 , a photosensor (PD) 183 , a wireless chip 184 and a battery 185 . A CPU 181 , a photosensor 183 and an LED 182 are mounted on the circuit board 188 .

The CPU 181 controls the operation of each section within the sensor unit 180 . The CPU 181 is
Based on the amount of light received from the photosensor 183, various arithmetic processing such as calculating the absorbance may be performed. The CPU 181 includes functions as a pressure unit driving section 186 and a motor driving section 187 . The pressure unit driving section 186 outputs drive signals to the pressure units 113A, 114A, and 115A. The motor drive section 187 outputs a drive signal to the motor 175 that rotates the take-up reel 172 . The CPU 181 has a clock function and may measure the time of sampling and the time of measurement.

The CPU 181 generates measurement data such as absorbance. The measurement data are data relating to components to be managed (eg, blood, amylase, bilirubin). The measurement data may be managed in association with the time when the measurement data was measured. The measurement data may include, for example, information on the absorbance of the component to be managed and the amount of change in absorbance. The measurement data may include information on the amount of controlled component emissions per unit time. Measured data may include information about total emissions of controlled ingredients. The discharge amount of the managed component may be the discharged amount of the managed component flowing through the main tube 130, or the discharged amount of the managed component sampled through the sub-tube 133 (sampling amount). good.

The LED 182 emits light having a peak value of a predetermined wavelength (for example, a wavelength of 405 nm) as measurement light. The photosensor 183 receives light scattered without being absorbed by the component to be managed such as amylase, and outputs a signal corresponding to the amount of received light.

Also, the LED 182 may be an LED capable of emitting visible light, or an LED capable of emitting visible light and non-visible light (for example, infrared light, ultraviolet light). LED 182 may include multiple LEDs. For example, the LED 182 may have an LED 182A that emits visible light and an LED 182B that emits infrared light (see FIG. 7A).

The wireless chip 184 wirelessly communicates with the drain monitor 20 and transmits various data measured by the sensor unit 180 to the drain monitor 20 . For wireless communication, short-range wireless communication (Bluetooth (registered trademark), ZigBee (registered trademark), etc.), wireless LAN (Loacl Area Network), or the like can be used. A battery 185 supplies power to each part of the sensor unit 180 . The battery 185 may be a secondary battery such as a rechargeable lithium ion battery or a primary battery such as an alkaline battery.

FIG. 3 is a diagram showing the shape of the drain bag 40. As shown in FIG. The drain bag 40 is a bag that stores drained fluid. An inflow tube 41 through which drained fluid flows is attached to the drain bag 40 . A tip of the inflow tube 41 is connected to one end of the drain tube 30 . Note that the inflow tube 41 may be part of the drain tube 30 . Drainage fluid flowing out from the drain tube 30 flows into the drain bag 40 and is stored therein. In addition, since the inside of the drain bag 40 is held at a negative pressure, even if the tip of the inflow tube 41 is connected to one end of the drain tube 30, the drain liquid accumulated in the drain bag 40 does not flow back into the drain tube 30. . In addition, maintaining a negative pressure also prevents infection of the patient who discharges the drain fluid.

A main tube 130 is connected to the drain tube 30 , and a sub-tube 133 branches off from the main tube 130 . A channel 133z is formed in the subtube 133 to sample and extract the drain fluid Lq. However, the channel 133z of the subtube 133 is basically closed when the drain liquid Lq does not pass. Therefore, the sub-tube 133 can prevent air or the like from entering the main tube 130 side (drain tube 30 side) from the flow path 133z. Therefore, even if the drain sensor 10 is provided with the main tube 130 and the sub-tube 133 , it is possible to prevent air from entering through the sub-tube 133 and maintain the negative pressure of the drain bag 40 . Therefore, it is possible to suppress backflow of the drain fluid stored in the drain bag 40 to the drain tube 30 . It was confirmed that gas such as air was hardly mixed in the drain bag 40 even after one week had passed while the drain sensor 10, the drain tube 30, and the drain bag 40 were connected. rice field.

FIG. 4 is a partially broken perspective view showing the appearance of the drain monitor 20. As shown in FIG. Drainage monitor 20 has a box-shaped housing 20z. A display 21 is arranged on the front surface of the housing 20z. The display 21 displays a graph 22 showing the measurement results over time, various descriptive texts 23 such as the patient's name, a meter 24 showing the current value of the measurement results, and the patient's condition (normal/abnormal). A state marker 25 or the like for the purpose is displayed.

The drain monitor 20 includes a CPU 26 for various controls of the drain monitor 20, a memory 27 for recording measurement data of the drain monitor 10, and a wireless chip 184 of the drain monitor 10 for wireless communication. A wireless chip 28 is provided to perform the

In addition, the drain liquid monitor 20 has an internal clock (not shown) built in, and the measurement data measured by the drain liquid sensor 10 (specifically, the sensor unit 180) and the time when the measurement data was measured , are associated with each other and recorded in the memory 27 . The measurement data may include information on the amount of controlled component emissions per unit time. The information on the discharge amount of the component to be managed per unit time of the drain effluent Lq includes, for example, information on the absorbance of the component to be managed (for example, amylase, bilirubin, blood) and the amount of change in absorbance per unit time. good. The graph 22 displays changes over time in the measurement results based on the time-series data recorded in the memory 27 . The measurement data may also be information on the total emission amount of the controlled component.

The CPU 26 may register (hold) part or all of the time-series data recorded in the memory 27 and at least one of the display results of the graph 22 in the electronic medical record for each patient. The electronic chart may be stored in the memory 27 or may be stored in a server (not shown) separate from the drain monitor 20 . If the electronic medical chart is stored on a server, the drain monitor 20 can be configured to allow registration and viewing of the electronic medical chart by communicating with the server via the wireless chip 28 .

(Operation of drainage sampling mechanism)
5A and 5B are diagrams for explaining the operation of the drainage sampling mechanism 110. FIG. When the main tube 130 is in a no-pressure state (state A) where the main tube 130 is not pressed, a liquid (eg, drain fluid, distilled water) flows through the main tube 130 .

First, the restricting members 113 and 114 press the main tube 130 substantially simultaneously to restrict the flow of liquid (state B). The inside of the main tube 130 on both sides of the branch point, that is, the central portion 130c of the tube, is blocked by partition plates 113B and 114B (see state B). This restricts the flow of liquid inside and outside the tube central portion 130c. In addition, the liquid may flow slightly without being completely blocked. A certain amount of liquid between the restricting members 113 and 114 stays in the tube central portion 130c. In state B, the channel 133z of the sub-tube 133 is closed, and the channel 133z does not allow liquid to pass through.

The restricting members 113 and 114 press the main tube 130 substantially at the same time, and in a state in which the liquid stays in the tube central portion 130c of the main tube 130, the first pressing member 115 presses the tube central portion 130c of the main tube 130 ( State C). When the tube center portion 130c is pressed, the pressure of the liquid staying in the tube center portion 130c of the main tube 130 increases. Due to this increase in the pressure of the liquid, the channel 133z of the sub-tube 133 connected to the main tube 130 at the branch point widens. The liquid staying in the tube center portion 130c of the main tube 130 flows into the flow path 133z of the subtube 133 and flows out from the opposite end surface of the subtube 133 . When almost all the liquid has flowed out, the central tube portion 130c of the main tube 130 becomes depressed. Thereby, a certain amount of liquid that has accumulated between the restricting members 113 and 114 can be delivered through the sub-tube 133 . Therefore, in state C, the channel 133z of the subtube 133 is open and the channel 133z allows liquid to pass through.

In a state where the first pressing member 115 presses the central portion 130c of the main tube 130, the restricting members 113 and 114 stop pressing, except for the locations (two locations) on both sides of the branch point of the main tube 130. pressure (state D). Further, when the first pressing member 115 releases the pressing force on the tube central portion 130c, the main tube 130 returns to the state A and becomes a pressureless state. It should be noted that by entering state A following state D, it is possible to suppress backflow of liquid from the sub-tube 133 to the main tube 130 due to a decrease in the pressure in the pipe central portion 130c.

In addition, when state A is followed by state B, a new fixed amount of liquid that has been circulating in the main tube 130 can be stagnated and secured.

By repeating state A to state D, the drainage sampling operation can be performed continuously, and a constant amount of liquid can be extracted. The liquid sampling operation by the liquid sampling mechanism 110 is applicable not only to the drain liquid Lq but also to various liquids as liquid sampling operations by the liquid sampling mechanism.

FIG. 6 is a flow chart showing the procedure of the drain liquid sampling operation by the drain liquid sensor 10. As shown in FIG. The CPU 181 waits until the sampling time (S1). The sampling period is set at an appropriate time, for example, once an hour. When it is time to sample, the CPU 181 outputs drive signals to the pressurizing units 113A and 114A to start pressing by the limiting members 113 and 114 (S2). When the restriction members 113 and 114 press both sides of the main tube 130 sandwiching the branch point, the tube central portion 130c of the main tube 130 is blocked by the partition plates 113B and 114B. Liquid stays in the tube center portion 130 c of the main tube 130 .

While maintaining the pressing by the limiting members 113 and 114, the CPU 181 outputs a drive signal to the pressing unit 115A to start pressing by the first pressing member 115 (S3). When the tube central portion 130c of the main tube 130 is pressed, the pressure of the liquid staying in the tube central portion 130c increases. Due to this increase in the pressure of the liquid, the channel 133z of the sub-tube 133 widens. The liquid staying in the tube central portion 130c of the main tube 130 passes through the channel 133z of the subtube 133 and flows out from the end face on the opposite side of the channel 133z. When almost all of the liquid has flowed out, the central tube portion 130c of the main tube 130 becomes depressed.

The CPU 181 outputs a drive signal to the pressurizing unit 115A, stops the drive signal to the pressurizing units 113A and 114A while maintaining the pressing operation by the first pressing member 115, and releases pressure by the restricting members 113 and 114. is started (S4). Even if the pressure is released by the restricting members 113 and 114, the central tube portion 130c of the main tube 130 remains in a recessed state.

The CPU 181 stops the drive signal to the pressurizing unit 115A and starts depressurization by the first pressing member 115 (S5). When the pressure is released by the first pressing member 115 , the pressure-free state is restored and the liquid flows through the central portion 130 c of the main tube 130 . The direction of fluid flow is from the patient side toward the drain bag 40 .

According to the operation procedure of the drainage sampling, the drain drainage management system 5 can control the states A to D and easily transition the states A to D. FIG. This allows the drain fluid management system 5 to quantitatively and continuously sample the drain fluid.

(Measurement of sampling solution)
Next, a method for measuring the amount of enzyme contained in the drain effluent sampled by the effluent sampling mechanism 110, that is, the sampling liquid sq will be described.

As described above, the blood cell separation/enzyme reaction mechanism 150 separates the blood cells contained in the drain effluent, reacts the enzyme with the reagent, and optically measures the amount of the enzyme. Blood cell separation/enzyme reaction mechanism 150 receives sampling liquid sq sampled by drainage sampling mechanism 110 through channel 210 (flow cell) (see FIG. 7A) included in measurement tape 200 . The flow path 210 transports at least a portion of the received sampling liquid sq, and supports measurement of the properties of the liquid using the measurement light.

(Structure of flow path)
FIG. 7A is an exploded perspective view showing an example of a channel 210 formed in the measurement tape 200. FIG. 7B is a plan view showing an example of the adhesive layer 240 in the channel 210. FIG. FIG. 7C is a cross-sectional view showing an example of the channel 210. As shown in FIG. The flow path 210 introduces the sampling liquid sq and transfers at least part of the sampling liquid sq. The sent sampling liquid sq is irradiated with measurement light, and the characteristics of the sampling liquid sq are measured.

The channel 210 has a porous sheet 220 , affinity sheets 230A and 230B, and an adhesive layer 240 . The porous sheet 220 and the affinity sheet 230A may be arranged adjacent to each other and may be positioned on the upper surface of the channel 210 . The affinity sheet 230B may be positioned on the bottom surface of the channel 210 and may serve as a base material. The adhesive 241 included in the adhesive layer 240 may be positioned on the side of the channel 210 .

The porous sheet 220 may be, for example, a fluorine porous film or a porous film made of a material other than fluorine. The porous sheet 220 may have a non-affinity for bodily fluids. The porous sheet 220 has a plurality of micropores 221 . The fine hole 221 serves as a through hole for keeping the pressure in the channel 210 at atmospheric pressure. Therefore, even if the channel 210 does not have an exhaust port, the inside of the channel 210 will not be sealed, and the micropores 221 of the porous sheet 220 will allow ventilation. The porous sheet 220 may be translucent to measurement light (for example, light for measuring amylase or bilirubin, light with a peak wavelength of 405 nm).

The affinity sheet 230A has an affinity for the sampling liquid sq. The affinity sheet 230A may be an affinity PET (polyethylene terephthalate) sheet and an affinity base material. The affinity sheet 230A may have translucency with respect to the measurement light. Affinity sheet 230A may be, for example, an affinity film. Also, the affinity sheet 230A may have through holes 222 . For example, the sampling liquid sq from the drainage sampling mechanism 110 is introduced into the through hole 222 .

The affinity sheet 230B has an affinity for the sampling liquid sq. The affinity sheet 230B may be an affinity PET sheet or an affinity base material. The affinity sheet 230B may have translucency with respect to the measurement light. The affinity sheet 230B may have the first reagent 231 placed on at least a part of the surface facing the adhesive layer 240 .

The adhesive layer 240 is arranged between the porous sheet 220 and the affinity sheet 230A and the affinity sheet 230B. Adhesive layer 240 includes porous sheet 220 and adhesive 241 for adhering affinity sheet 230A and affinity sheet 230B. Spaces 242 , 243 , and 245 are defined where the adhesive 241 is absent in the adhesive layer 240 .

Space 242 communicates with through hole 222 of affinity sheet 230A. A blood cell separation membrane 244 is arranged in the space 242 . Therefore, when the sampling liquid sq is dropped, it reaches blood cell separation membrane 244 arranged in space 242 . Blood cell separation membrane 244 receives sampling liquid sq introduced into through hole 222 and adsorbs a portion of sampling liquid sq. The adsorption force of the blood cell separation membrane 244 may differ for each component to be managed (eg, blood cells, amylase, bilirubin).

A porous membrane 246 is arranged in the space 243 . The porous membrane 246 has an affinity for the sampling liquid sq. The porous membrane 246 is, for example, a nonwoven fabric, or may be another porous membrane. The porous membrane 246 may have fibers. The fibers of the porous membrane 246 are coated with a second reagent 247 and further coated with a water-soluble polymer 248 (see the enlarged portion around the porous membrane in FIG. 7C). For example, the second reagent 247 is dropped onto the porous membrane 246 and dried, and then the water-soluble polymer 248 is dropped and dried. As a result, the structure near the porous membrane 246 is coated with the second reagent 247 on the outside of the fibers of the porous membrane 246 and the water-soluble polymer 248 on the outside thereof. Water soluble polymer 248 may be solid prior to dissolution. The type and amount of water-soluble polymer 248 may be adjusted according to the substance to be measured (eg amylase, bilirubin).

A space 245 is defined between the space 242 and the space 243 , that is, between the blood cell separation membrane 244 and the porous membrane 246 . The space 245 connects the blood cell separation membrane 244 arranged in the space 242 and the porous membrane 246 arranged in the space 243, and is a space in which liquid actually moves. Therefore, space 245 is the interior of channel 210 through which liquid actually flows.

Sampling liquid sq2 not adsorbed by blood cell separation membrane 244 flows out to space 245 . The sampling liquid sq2 is sent through the space 245 to the porous membrane 246 arranged in the space 243 by the force caused by the affinity with the affinity sheets 230A and 230B. The forces caused by the affinity with the affinity sheets 230A and 230B are, for example, capillary force and surface tension of the affinity sheets 230A and 230B. The sent sampling liquid sq2 reaches and permeates the porous membrane 246 and dissolves the water-soluble polymer 248 . When the water-soluble polymer 248 dissolves, the second reagent 247 also dissolves. In this manner, the sampling liquid sq2, the water-soluble polymer 248, and the second reagent 247 are mixed to generate a mixed liquid sq3, which is stored in the porous membrane 246. FIG. The liquid mixture sq3 stored in the porous membrane 246 may react with the first reagent 231 arranged on the affinity sheet 230B (see FIG. 8D, etc.).

The porous film 246 in which the liquid mixture sq3 is stored is irradiated with measurement light from the LEDs 182 (for example, LEDs 182A and 182B) of the sensor unit 180 . The liquid mixture sq3 scatters at least part of the irradiated measurement light. Scattered light (scattered light) can be received by the photosensor 183 . Based on the light received by the photosensor 183, the CPU 181 (see FIG. 2A) measures the properties (for example, the amount of change in absorbance) of the liquid mixture sq3 (for example, amylase).

Next, the size (width, that is, length along the liquid feeding direction) of the space 245 is examined.

The size of the space 245 is preferably greater than 0 and as small (short) as possible. If the space 245 is long, a large liquid feeding force is required, which is not preferable. The width of the space 245 is, for example, approximately 100 μm to 3000 μm, preferably approximately 500 to 1500 μm. This makes it easier for the flow path 210 to keep the liquid feeding amount constant, and can reduce variations in the measurement results of the liquid mixture sq3.

Next, the positional relationship of the members of each layer of the channel 210 will be described.

The channel 210 has a three-layer structure of a bottom layer, an intermediate layer, and a top layer. An affinity sheet 230B is arranged on the bottom layer. An adhesive layer 240 is arranged in the intermediate layer. A porous sheet 220 and an affinity sheet 230A are arranged in the uppermost layer. A space 245 and a porous membrane 246 are present in the adhesive layer 240 .

The entire upper surface of the space 245 faces the affinity sheet 230A along the liquid feeding direction. Therefore, in the space 245, the sampling liquid sq2 can be sent by receiving the force due to the affinity of the affinity sheet 230A as well as the force due to the affinity of the affinity sheet 230B. In addition, since the porous sheet 220 is not positioned on the upper surface of the space 245 in the flow path 210, at least part of the sampling liquid sq2 that has reached the space 245 leaks to the outside through the micropores 221 of the porous sheet 220. can be suppressed.

The porous membrane 246 faces at least a portion of the porous sheet 220 . Therefore, at least part of the porous sheet 220 exists downstream of the space 245 in the liquid feeding direction. In this case, even when liquid is sent from the blood cell separation membrane 244 to the porous membrane 246 through the space 245 , the gas in the channel 210 can escape through the porous sheet 220 . Therefore, the flow path 210 can maintain the downstream side of the space 245 at the atmospheric pressure, suppress the downstream pressure from rising due to the feeding of the sampling liquid sq2, and inhibit the liquid feeding from being hindered. FIG. 7C and the like illustrate that about half of the area of the porous membrane 246 along the liquid feeding direction faces the porous sheet 220 .

Next, specific materials for each member in the channel 210 will be described.

The first reagent 231 may be, for example, the enzyme reagent (R-1) of "N-assay L AMY G7 Nittobo" manufactured by Nittobo Medical Co., Ltd. The enzymatic reagent (R-1) has an α-glucosidase component. The second reagent 247 may be, for example, the substrate reagent (R-2) of "N-assay L AMY G7 Nittobo" manufactured by Nittobo Medical Co., Ltd. Substrate reagent (R-2) has a component of 4,6-ethylidene-4-nitrophenylmaltoheptaoside.

The water-soluble polymer 248 may be "Acpana AP50", "PEO-1", "HEC AL-15", etc. manufactured by Sumitomo Seika. When "HEC AL-15" is used as the water-soluble polymer 248, the liquid mixture sq3 can be measured particularly stably. This is probably because the dissolution rate of the water-soluble polymer 248 is high.

As the porous sheet 220, PTFE porous membrane 1033-N6T manufactured by Nitto Denko may be used.

As the affinity sheets 230A and 230B, a PET film obtained by converting Lumirror Type S manufactured by Toray Industries, Inc. (for example, Lumirror Type S10, S15, S105, S56) into SiO ₂ by sputtering may be used. As the affinity sheets 230A and 230B, hydrophilic treated film #9901P (a hydrophilic PET film using a surfactant) manufactured by 3M Japan Limited may be used. Both affinity sheets 230A and 230B have hydrophilicity (affinity for sampling liquid sq). Due to the affinity of the affinity sheets 230A and 230B, the flow path 210 is capable of feeding even if the sampling liquid sq contains a high-protein, high-viscosity liquid such as plasma.

As the porous membrane 246, filter paper LF1 manufactured by GE may be used.

The adhesive 241 may have the properties of any of the following adhesives (1), (2), and (3).

<Adhesive (1)>
Material: Acrylic adhesive Thickness: 0.2 (mm)
When the adhesive (1) is used, since the acrylic adhesive is hydrophobic (has no affinity for the sampling liquid sq), leakage of the sampling liquid sq2 from the channel 210 does not occur. In addition, since the thickness of the adhesive (1) is thin, the liquid feeding speed of the sampling liquid sq2 is high. In addition, since the adhesive (1) has a relatively high elastic modulus, it is difficult to deform, and the adhesive hardly adheres to the blade used for punching out the adhesive, so that it is easy to handle. This handling corresponds to the adhesion performance between the top porous sheet 220 and affinity sheet 230A and the bottom affinity sheet 230B. Therefore, good handling indicates high adhesion performance.

<Adhesive (2)>
Material: Acrylic adhesive Thickness: 0.2mm
When the adhesive (2) is used, since the acrylic adhesive is hydrophobic (has no affinity for the sampling liquid sq), leakage of the sampling liquid sq2 from the channel 210 does not occur. In addition, since the thickness of the adhesive (2) is thin, the liquid feeding speed of the sampling liquid sq2 is high. In addition, since the adhesive (2) has a relatively small elastic modulus, it is easily deformed, and the adhesive easily adheres to the blade used when punching out the adhesive. Inferior.

<Adhesive (3)>
Material: Acrylic adhesive Thickness: 0.4mm
When the adhesive (3) is used, since the acrylic adhesive is hydrophobic (has no affinity for the sampling liquid sq), leakage of the sampling liquid sq2 from the channel 210 does not occur. Also, since the adhesive (3) is thicker than the adhesives (1) and (2), the liquid feeding speed of the sampling liquid sq2 is lower than that of the adhesives (1) and (2). In addition, since the adhesive (3) is thicker than the adhesives (1) and (2), the adhesive may be crushed and the inside of the flow path 210 may be blocked. It is inferior to (2).

As the pressure-sensitive adhesive of the comparative example, an acrylic pressure-sensitive adhesive having a thickness of 0.1 mm can be considered. When the adhesive of the comparative example is used, leakage of the sampling liquid sq2 from the channel 210 occurs. This is thought to be due to the fact that the thickness of the adhesive is insufficient, a space is generated between the adhesive 241 and the blood cell separation membrane 244, and the blood cells (that is, the sampling liquid sq1) leak from this space. be done.

It should be noted that a stretchable adhesive has high adhesion to the porous sheet 220 and the affinity sheets 230A and 230B and is difficult to peel off, but the liquid leaks easily and the liquid feeding performance is lowered. In addition, the non-stretchable adhesive has low adhesion to the porous sheet 220 and the affinity sheets 230A and 230B and is easily peeled off. Thus, there is a trade-off relationship between the adhesiveness of the pressure-sensitive adhesive and the liquid transfer performance.

Next, movement of the sampling liquid sq in the channel 210 will be described.

8A, 8B, and 8C are diagrams for explaining how blood cell separation and enzymatic reaction are performed using the measurement tape 200. FIG. FIG. 8A is a cross-sectional view showing an example of introduction of the sampling liquid sq in the channel 210 of the measurement tape 200. FIG. 8B is a cross-sectional view showing an example of movement of the sampling liquid sq separated by the blood cell separation membrane 244 in the channel 210. FIG. FIG. 8C is a cross-sectional view showing an example of the sampling liquid sq2 reaching the porous membrane 246 to which the liquid is sent in the channel 210. FIG. FIG. 8D is a conceptual diagram showing an example of a process in which the mixed liquid sq3 is generated in the porous membrane 246. FIG.

Measuring tape 200 including channel 210 has a three-layer structure. The three-layer structure has an affinity sheet 230B arranged at the bottom layer, an adhesive layer 240 arranged thereon, and a porous sheet 220 and an affinity sheet 230A arranged at the top layer. Channel 210 is included in measuring tape 200 . The measurement tape 200 includes the through holes 222 of the affinity sheet 230A, the spaces 242, 243, 245 of the adhesive layer 240, the blood cell separation membrane 244, the porous membrane 246, the water-soluble polymer 248, the first reagent 231, the second A reagent 247 or the like is repeatedly formed along the measuring tape 200 . That is, the flow paths 210 shown in FIG. 8A are repeatedly formed along the measuring tape 200 .

The affinity sheet 230B may be laminated with the first reagent 231, and the affinity sheet 230B and the first reagent 231 may form an enzyme reaction sheet. In this case, the first reagent 231 may be dropped onto the affinity sheet 230B, dried, and transferred. A porous membrane 246 is arranged to face the position where the first reagent 231 is transferred. The sampling liquid sq2 reaches and permeates the porous membrane 246 and dissolves the water-soluble polymer 248 . When the water-soluble polymer 248 dissolves, the second reagent 247 also dissolves. In this manner, the sampling liquid sq2, the water-soluble polymer 248, and the second reagent 247 are mixed to generate a mixed liquid sq3, which is stored in the porous membrane 246. FIG. Then, the mixed solution sq3 (for example, a solution containing amylase) present on the lower portion of the porous membrane 246 (the surface facing the affinity sheet 230B) reacts with the first reagent 231 .

The blood cell separation membrane 244 can separate blood cells and non-blood cells (eg, amylase) based on the size of the components to be controlled (eg, blood cells, amylase, bilirubin) contained in the drain fluid, the adsorption of the components to be controlled, and the like. .

As shown in FIG. 8A, the sampling liquid sq flowing out from the channel 133z of the subtube 133 is introduced through the through hole 222 of the affinity sheet 230A and placed in the space 242 of the adhesive layer 240 communicating with the through hole 222. reaches the blood cell separation membrane 244 that has been formed.

Blood cell separation membrane 244 is composed of, for example, a glass membrane. The glass membrane is a sheet formed by bundling glass fibers, and is formed like a non-woven fabric. The glass membrane may be formed into a sheet by stacking and folding a large number of glass fibers.

Blood cell separation membrane 244 adsorbs components to be managed. The adsorption force of the blood cell separation membrane 244 may differ for each component to be managed (eg, blood cells, amylase, bilirubin). Also, the adsorption force of the blood cell separation membrane 244 may vary depending on the surface area of the blood cell separation membrane 244 . The size of the surface area of blood cell separation membrane 244 may be determined according to the density of blood cell separation membrane 244 . The glass membrane may be electrostatically attracted. Specifically, the glass fibers may be positively charged, the blood cells (for example, phospholipids of blood cells) in the sampling liquid may be negatively charged, and the two may be electrically attracted. On the other hand, the adsorption force between the glass fiber and the enzyme in the sampling solution may be weaker than the adsorption force between the glass fiber and blood cells. In this case, the enzyme may move on the glass fiber, flow out of the blood cell separation membrane 244 , and proceed to the space 245 .

When the sampling liquid sq flowing out from the flow path 133z of the subtube 133 is dripped onto the blood cell separation membrane 244, the blood cells are adsorbed on the blood cell separation membrane 244. FIG. Therefore, the sampling liquid sq<b>1 containing many blood cells (blood cell component) stays in the vicinity of the dropping position of the blood cell separation membrane 244 .

On the other hand, when the sampling liquid sq2 containing a large amount of enzyme (for example, amylase) is dropped onto the blood cell separation membrane 244, it is not immediately adsorbed at the dropping position of the blood cell separation membrane 244, and spreads from the dropping position, for example, as shown in FIG. 8B. Move to the left as shown. A part of the sampling liquid sq2 does not remain on the blood cell separation membrane 244 and seeps into the space 245 . Therefore, the sampling liquid sq1 containing many blood cells stays in the vicinity of the dropping position of the blood cell separation membrane 244, and is separated from the dropping position of the blood cell separation membrane 244 (for example, the edge of the blood cell separation membrane 244 and the space 245). , amylase-rich sampling fluid sq2 migrates.

In this manner, the blood cell separation membrane 244 separates the sampling liquid sq due to the difference in the adsorption force for each component in the sampling liquid sq. As a result, the blood cells as the sampling liquid sq1 remain on the blood cell separation membrane 244, and the non-blood cells (amylase and bilirubin) as the sampling liquid sq2 permeate from the blood cell separation membrane 244.

As shown in FIG. 8B, the sampling liquid sq2 that permeates through the blood cell separation membrane 244 enters the space 245. As shown in FIG. The space 245 (inside the flow path 210) is kept at the same pressure as the atmospheric pressure by the micropores 221 of the porous sheet 220 facing the porous membrane 246 positioned downstream in the liquid feeding direction. The space 245 is filled with the sampling liquid due to the affinity of the affinity sheet 230A located on the upper surface of the space 245 and the affinity sheet 230B located on the lower surface of the space 245 (for example, the surface tension of the affinity sheets 230A and 230B). sq2 is sent toward the space 243 .

As shown in FIGS. 8C and 8D, the sampling liquid sq2 sent through the space 245 reaches the porous membrane 246 arranged in the space 243 (state A1), permeates (state B1), dissolves the polar polymer 248 (state C1). When the water-soluble polymer 248 dissolves, the second reagent 247 coated on the fibers of the porous membrane 246 also dissolves (state D1). In this manner, the sampling liquid sq2, the water-soluble polymer 248, and the second reagent 247 are mixed to generate a mixed liquid sq3 (state D1), which is stored in the porous membrane 246. FIG. The mixed liquid sq3 has a higher viscosity than the sampling liquid sq2. The porous membrane 246 may be placed facing the first reagent 231 attached (eg, transferred) to the affinity sheet 230B. Mixed solution sq3 generated near porous membrane 246 reacts with first reagent 231 . If the enzyme is an amylase, the first reagent 231 reacts with the amylase and turns the amylase yellow. In addition, the amylase that has reacted with the first reagent 231 absorbs part of the measurement light.

The amylase that has reacted with the first reagent 231 tends to absorb light with a wavelength of 405 nm. On the other hand, the absorption wavelength of blood cells is 420 nm. Therefore, when measuring light having a peak value of 405 nm is projected onto the amylase that has reacted with the first reagent 231, and the absorbance of amylase is measured from the scattered light based on the measuring light, it partially overlaps with the absorption wavelength of 420 nm of blood cells. , making accurate measurements difficult. Therefore, the blood cell separation/enzyme reaction mechanism 150 separates blood cells and non-blood cells (for example, amylase and bilirubin) and measures absorbance and the like.

Therefore, the sensor unit 180 measures the absorbance of amylase contained in the liquid mixture sq3 that has permeated the measurement tape 200 fed by the tape winding and feeding mechanism 170 . When measuring the absorbance of amylase, the LED 182 of the sensor unit 180 emits measurement light with a peak value of 405 nm, which is an absorption wavelength, to the measurement tape 200 permeated by the mixture sq3 (specifically, the measurement tape 200 where the mixture sq3 is located). Projection onto the enzyme reaction sheet and the porous membrane 246 above it. The photosensor 183 of the sensor unit 180 receives the light projected from the LED 182 and scattered without being absorbed by the amylase in the liquid mixture sq3. The CPU 181 of the sensor unit 180 measures the absorbance of amylase contained in the liquid mixture sq3 based on the amount of scattered light received by the photosensor 183 . The CPU 181 estimates the concentration of amylase based on the absorbance of amylase. The concentration of amylase (amylase activity) represents the ability of amylase to react with the first reagent 231 and is expressed in units of U/L. The CPU 181 calculates the concentration of amylase, for example, based on the amount of change ΔA in the absorbance of amylase.

Here, since the mixed liquid sq3 contains the water-soluble polymer 248, the viscosity of the mixed liquid sq3 is higher than that of the sampling liquid sq2. Therefore, the enzymatic reaction rate between the mixed liquid sq3 and the first reagent 231 becomes slower than the enzymatic reaction rate between the sampling liquid sq2 and the first reagent 231 . Therefore, the amount of change in absorbance per unit time becomes small. In addition, since the mixed solution sq3 contains the water-soluble polymer 248, the concentration of amylase contained in the mixed solution sq3 becomes relatively small (diluted), and the blood cell separation/enzyme reaction mechanism 150 measures the amount of change in absorbance. The concentration value of amylase corresponding to the possible upper limit can be reduced, and a higher concentration of amylase can be derived.

Next, an example of deriving the concentration of amylase based on the amount of change in absorbance of high-concentration amylase will be described.

As shown in FIGS. 14 and 15, the relationship between the concentration of amylase and the amount of change in absorbance varies in the range of high amylase concentration (high-concentration amylase) when amylase is directly measured. Therefore, various concentrations of amylase are prepared, for example, ranging from low-concentration amylase to high-concentration amylase. The concentration of each prepared amylase is measured, for example, by a known technique. A given amylase may be diluted with different dilution volumes to obtain different concentrations of amylase. Then, the absorbance of amylase at various concentrations is measured.

The relationship between the concentration of each amylase and the corresponding change in absorbance is plotted at sample points (see FIG. 9). FIG. 9 is a diagram showing an example of a calibration curve L11 based on each sample point showing the relationship between the concentration of amylase and the amount of change in absorbance. The obtained information of each sample point may be held in a memory (not shown) of the blood cell separation/enzyme reaction mechanism 150 .

The CPU 181 calculates the calibration curve L11 based on each sample point held in the memory and showing the correspondence relationship between the concentration of amylase and the amount of change in absorbance. The calibration curve L11 may be represented by a linear straight line or a non-linear curve. The CPU 181 uses the calibration curve L11 to measure the amount of change in the absorbance of amylase, and based on this measurement result, various concentrations of amylase ranging from low to high, for example, can be calculated. . The calibration curve L11 may be derived by an external device other than the drain sensor 10 and stored in the memory of the blood cell separation/enzyme reaction mechanism 150. FIG.

FIG. 10 is a conceptual diagram showing an example of steps for measuring the properties of high-concentration amylase. The process of FIG. 10 includes the case of measuring the characteristics of the high-concentration amylase (for example, the amount of change in absorbance) in order to derive the calibration curve L11, and the case of feeding the liquid through the flow channel 210 based on the calibration curve L11. It is carried out both when measuring high-concentration amylase and when measuring. In FIG. 10, "" indicates measurement points measured by a method that does not use a water-soluble polymer, and "▪" indicates measurement points that were measured by a method that uses a water-soluble polymer.

The concentration of amylase may be adjusted in the measurement for deriving the calibration curve L11. That is, a plurality of amylase solutions with different concentrations are prepared by diluting high-concentration amylase with a predetermined solution (corresponding to the mixing described above). This predetermined liquid may be, for example, water, the same material as the water-soluble polymer 248 used in the channel 210, or other materials. For example, the same reagent as the first reagent 231 and the second reagent 247 is dropped into each amylase solution having different concentrations. A predetermined measurement device projects measurement light similar to light used in actual measurement to the liquid of each amylase to which the reagent has been dropped, and measures the absorbance of each amylase based on the amount of received scattered light. As a result, the predetermined measuring device can derive the correspondence relationship between the concentration of each amylase and the amount of change in each absorbance. Information on the derived correspondence relationship is stored in the memory before measurement of the liquid mixture sq3 using the channel 210 . Note that the CPU 181 may perform the derivation of the correspondence relationship between the concentration of each amylase and the amount of change in each absorbance. The predetermined measuring device may be the drain sensor 10 or some other device. The correspondence may be represented by, for example, a calibration curve L11.

After the information of the calibration curve L11 is stored in the memory, the blood cell separation/enzyme reaction mechanism 150 measures the high-concentration amylase sent through the flow path 210 based on the calibration curve L11. In this case, the high-concentration amylase as the sampling liquid sq2 reaching the porous membrane 246 in the channel 210 dissolves the water-soluble polymer 248, and the high-concentration amylase and the water-soluble polymer 248 are mixed. Furthermore, the second reagent 247 is mixed with the high-concentration amylase and the water-soluble polymer 248 to generate a mixed solution sq3. At least part of the mixture sq3 reacts with the first reagent 231 . Blood cell separation/enzyme reaction mechanism 150 projects measurement light onto liquid mixture sq3 that has reacted with first reagent 231, and measures the amount of change in absorbance of liquid mixture sq3 based on the amount of received scattered light. Then, the CPU 181 refers to the information of the calibration curve L11 held in the memory, and calculates the concentration of amylase corresponding to the amount of change in the measured absorbance of the liquid mixture sq3. Thereby, the blood cell separation/enzyme reaction mechanism 150 can derive the concentration of high-concentration amylase based on the optical measurement.

Thus, in flow path 210 , liquid is sent from blood cell separation membrane 244 to porous membrane 246 through space 245 , and mixed liquid sq3 is stored in porous membrane 246 . The liquid mixture sq3 moves downstream in the liquid feeding direction at a constant speed. In addition, since the amount of the mixed liquid sq3 that can be stored in the porous membrane 246 is constant, a fixed amount of the mixed liquid sq3 advances at a constant speed, and the mixed liquid sq3 reacts with the first reagent 231 by a fixed amount. , the measurement variation caused by the variation in the amount of the mixture sq3 can be suppressed.

In addition, the channel 210 is provided with a space 245 between the blood cell separation membrane 244 and the porous membrane 246, thereby preventing the liquid retained in the blood cell separation membrane 244 and the liquid retained in the porous membrane 246 from mixing. It is possible to suppress variations in liquid volume. Space 245 is configured with a predetermined size. During liquid feeding, the entire space 245 is filled with the sampling liquid sq2, and the sampling liquid sq2 is absent in the space 245 after the liquid feeding. Therefore, after the liquid is sent, the blood cell separation membrane 244 side and the porous membrane 246 side are separated by the space 245, and the amount of liquid stored in the porous membrane 246 becomes constant.

Further, the blood cell separation/enzyme reaction mechanism 150 can generate a liquid mixture sq3 based on the sampling liquid sq2 that has reached the porous membrane 246 and the water-soluble polymer 248 . When the mixed liquid becomes sq3, the viscosity becomes higher and the enzymatic reaction time becomes longer. This is presumably because the increased viscosity of the liquid reduces the number of times the molecules come into contact with each other per unit time, delaying the enzymatic reaction time. The concentration of amylase and the amount of change in absorbance basically have a relationship such that the higher the concentration of amylase, the larger the amount of change in absorbance. Therefore, when the amount of change in absorbance of the mixed solution sq3 is measured, the amount of change in absorbance per unit time is smaller than when the amount of change in absorbance of the actual amylase concentration is measured. Therefore, it takes longer to reach the upper limit of the amount of change in absorbance, and the same result as when the concentration of amylase is lowered is obtained as the measurement result of the amount of change in absorbance of the mixture sq3. Therefore, it is possible to obtain a high correlation between the amount of change in absorbance and the concentration of amylase in a wider amylase concentration range than in the past. Therefore, the blood cell separation/enzyme reaction mechanism 150 can improve the accuracy of deriving the amylase concentration, which has a higher concentration, based on, for example, a calibration curve showing the correlation.

In addition, the drain drainage sensor 10 uses the water-soluble polymer 248 to generate a mixed solution sq3 simulating the dilution of the sampled sq3, and uses the mixed solution sq3 to measure, for example, the measurement accuracy of the characteristics of high-concentration amylase can be improved. In addition, the drain sensor 10 can stably measure amylase concentrations of 2000 U/L or more while suppressing measurement variations. Therefore, it becomes easier for doctors to use the drain sensor 10 in the medical field to measure the concentration of amylase. In addition, the drain sensor 10 can measure mechanically by devising the configuration around the porous membrane 246 and the first reagent 231 of the drain sensor 10 without improving the reagent, which is difficult to improve. It is possible to improve accuracy.

FIG. 11 is a flow chart showing the procedure for measuring amylase activity by the drain management system 5. As shown in FIG. This measurement is set at an appropriate time, for example once an hour, like the drainage sampling operation.

The CPU 181 of the sensor unit 180 outputs a command signal via the motor driving section 187 to drive the motor 175 so as to feed the measuring tape 200 in the winding direction (S11). When the motor 175 rotates, the take-up reel 172 rotates so that the through-hole 222 of the flow path 210, which is the dropping point, is positioned directly below (opposite to) the sub-tube 133 in order to perform the drainage sampling operation. Then, the measuring tape 200 is wound up, and the feed reel 171 feeds out the measuring tape 200 .

The CPU 181 performs a drainage sampling operation to drop the sampling liquid sq into the through hole 222 of the flow path 210 of the measurement tape 200 (S12). This drainage sampling operation may be performed according to the procedure shown in the flowchart of FIG.

The CPU 181 waits for a predetermined time to separate the blood cells and move the sampling liquid sq. During this predetermined waiting time, the sampling liquid sq dropped onto the blood cell separation membrane 244 through the through hole 222 of the measurement tape 200 is separated into blood cell components and non-blood cell components by the blood cell separation membrane 244 (S13). Among the sampling liquids sq, the sampling liquid sq1 containing many blood cells stays near the dropping position, and the sampling liquid sq2 containing amylase moves away from the dropping position and enters the space 245 (S13). The sampling liquid sq2 that has entered the space 245 moves due to the force (for example, surface tension) caused by the affinity between the affinity sheets 230A and 230B and reaches the porous membrane 246 (S13). The sampling liquid sq2 then permeates the porous membrane 246 and dissolves the water-soluble polymer 248 . When the water-soluble polymer 248 dissolves, the second reagent 247 coated on the fibers of the porous membrane 246 also dissolves. As a result, a liquid mixture sq3 is generated and stored in the porous membrane 246 .

The CPU 181 waits for the reaction time between the amylase in the liquid mixture sq3 and the first reagent 231 . During this reaction time, the amylase contained in the mixed liquid sq3 stored in the porous membrane 246 reacts with the first reagent 231 present at the opposite position of the porous membrane 246, and the reacted amylase turns yellow (S14). .

The CPU 181 optically reads the reaction site between the amylase and the first reagent 231 (S15). In this optical reading, the CPU 181 turns on the LED 182 (for example, at least one of the LEDs 182A and 182B) and projects measurement light toward the reaction site (enzyme reaction sheet, porous membrane 246, liquid mixture sq3). At the reaction site, part of the projected measurement light is absorbed by the amylase and the remaining part is scattered. The CPU 181 receives the light scattered by the photosensor 183 and calculates the amount of change in absorbance (ΔA) based on the amount of received light.

The CPU 181 calculates amylase activity based on the amount of change in absorbance (ΔA) (S16). The CPU 181 communicates with the drain monitor 20 via the wireless chip 184, and sends measurement data on amylase (for example, amylase absorbance change amount (ΔA), amylase activity value, amylase concentration value) as information on the measurement time. Send with

When the CPU 26 of the drain liquid monitor 20 receives the measurement data and the measurement time information regarding amylase from the drain liquid sensor 10 via the wireless chip 28, various data (measurement data, measurement time, other data) is displayed (S17).

According to such a procedure for measuring a component to be managed (for example, amylase), the drain drainage management system 5 controls each part of the blood cell separation/enzyme reaction mechanism 150 by the CPU 181 so that the drain drainage is sampled. Properties of liquid sq can be automatically measured and measurement data derived. In addition, the drain liquid management system 5 can display information on the drain liquid monitor 20, and can visualize information related to components to be managed such as measurement data. Therefore, the user can easily grasp the recovery tendency of the patient.

In addition, the drain sensor 10 separates blood cells and amylase using the blood cell separation membrane 244, and then measures the separated amylase. Excellent performance and cost reduction.

FIG. 12 is a diagram showing the display of the drain liquid monitor 20. As shown in FIG. A display 21 arranged in front of the drain monitor 20 may display, as an example, a graph 22 showing the measurement results of the amount of change in absorbance (ΔA) representing amylase activity. In addition, the display 21 also includes various descriptive texts 23 such as the patient's name, a meter 24 representing the amount of change in absorbance (ΔA), and a state marker 25 for notifying the patient's state (normal/abnormal). may be displayed.

In graph 22, dashed line L1 indicates the upper limit of the normal range, and dashed line L2 indicates the lower limit of the normal range. If the postoperative condition of the patient is normal, the amount of change in absorbance due to amylase in the drain fluid flowing through the drain tube 30 connected to the patient's body gradually decreases with the passage of time after the operation. In this example, the temporal transition of each measurement result is maintained within the normal range. At this time, the characters "Normal" are displayed as the status marker 25 . On the other hand, when the change over time of each measurement result is out of the normal range, the character “abnormal” may be displayed as the state marker 25 .

(measurement of bilirubin)
In the above description, amylase, which is a digestive enzyme, has been mainly described as a component to be managed in drain effluent Lq. Bilirubin contained in bile and urine, which is an example of organ secretions, can also be one of the components to be managed. Since bilirubin itself has a yellow pigment, it is possible to optically detect the concentration of bilirubin without contact. Therefore, when measuring the concentration of bilirubin, it is not necessary to react with the first reagent 231, and the first reagent 231 is unnecessary. Bilirubin may be measured using the measurement tape 200 having the channel 210 described in FIG. 7A and the like, except that the first reagent 231 is not included. That is, the mixture sq3 may be irradiated with measurement light, and the bilirubin concentration and the like may be measured based on the scattered light.

Bilirubin can also be membrane-separated like amylase. That is, bilirubin, which is an example of non-blood cells contained in the sampling liquid sq, has a lower affinity for blood cell separation membrane 244 than blood cells, and is less likely to be adsorbed by blood cell separation membrane 244 than blood cells. Therefore, bilirubin moves along the blood cell separation membrane 244 and enters the space 245 by capillary action, for example. Bilirubin moves toward the porous membrane 246 due to the force (for example, surface tension) caused by the affinity with the affinity sheets 230A and 230B in the space 245, reaches the porous membrane 246, and permeates the porous membrane 246, The water-soluble polymer 248 is dissolved. When the water-soluble polymer 248 dissolves, the second reagent 247 coated on the fibers of the porous membrane 246 also dissolves. As a result, a mixed solution sq3 containing bilirubin is generated and stored in porous membrane 246 .

In the membrane measurement, when the sampling liquid sq is dropped onto the blood cell separation membrane 244, the blood cells are preferentially adsorbed to the blood cell separation membrane 244 due to the difference in adsorption power between blood cells and bilirubin. That is, the adsorption power of blood cells to blood cell separation membrane 244 is greater than the adsorption power of bilirubin to blood cell separation membrane 244 . In blood cell separation membrane 244 , blood cells are adsorbed in the vicinity of the dropping position, and at least part of bilirubin is not adsorbed and seeps into space 245 . The exuded bilirubin reaches and permeates the porous membrane 246 and dissolves the water-soluble polymer 248 . When the water-soluble polymer 248 dissolves, the second reagent 247 coated on the fibers of the porous membrane 246 also dissolves. As a result, a mixed solution sq3 containing bilirubin is generated and stored in porous membrane 246 . The sensor unit 180 can measure the absorbance of bilirubin by measuring the porous membrane 246 in which the stored bilirubin is present, using light having a peak value of a wavelength of 405 nm as measurement light.

Therefore, the drain sensor 10 separates blood cells and bilirubin using the blood cell separation membrane 244, and then measures the separated bilirubin. Excellent performance and cost reduction.

Measurement data such as bilirubin absorbance may be sent to the drain monitor 20 and displayed on the display 21 .

(Modified example of measuring tape)
The measurement tape 200 includes a channel 210 containing the first reagent 231 used for measuring amylase (channel 210 for measuring amylase) and a channel 210 containing no first reagent 231 used for measuring bilirubin. 210 (channel 210 for bilirubin measurement) may be alternately included. That is, the measurement tape 200 may be manufactured so that the amylase measurement channel 210 and the bilirubin measurement channel 210 are repeated in the longitudinal direction of the measurement tape 200 . When measuring the properties of amylase, the drain sensor 10 uses the amylase measurement channel 210 in the measurement tape 200 . When measuring the properties of bilirubin, the drain sensor 10 uses the bilirubin measurement channel 210 in the measurement tape 200 .

Thus, the drain sensor 10 uses the measurement tape 200 having the channel 210 for measuring amylase and the channel 210 for measuring bilirubin. can be increased. In addition, since the drain sensor 10 can be shared in the measurement of a plurality of different components to be managed, costs can be reduced and space can be saved compared to the case where two drain sensors are provided. In addition, since only one measuring tape 200 is required for measuring a plurality of different components to be managed, costs can be reduced and space can be saved compared to the case where two measuring tapes 200 are used.

Although the embodiments have been described above with reference to the drawings, it goes without saying that the present disclosure is not limited to such examples. It is obvious that a person skilled in the art can conceive of various modifications or modifications within the scope described in the claims, and these also belong to the technical scope of the present disclosure. Understood. Moreover, each component in the above embodiments may be combined arbitrarily without departing from the gist of the invention.

In the above embodiment, two first reagents 231 and second reagents 247 are used as reagents for reacting with an enzyme (for example, amylase), but one reagent or three or more reagents may be used.

Although the water-soluble polymer 248 that is soluble in water is exemplified as the polymer in the above embodiment, other polymers (for example, oil-soluble polymer that is soluble in oil) may be used.

In the above embodiment, the affinity sheet 230B and the first reagent 231 form an enzyme reaction sheet as an example, but the present invention is not limited to this. For example, the first reagent 231 may be attached to a sheet different from the affinity sheet 230B, and this sheet may be processed into an arbitrary shape and arranged.

In the above embodiment, the drain fluid discharged from the living body through the drain tube 30 is exemplified for sampling and measurement, but liquids other than drain fluid may be sampled and measured. For example, a body fluid discharged from or introduced into a living body through a body fluid guide tube may be sampled or measured.

Fluid guide tubes may include, for example, drains (drain tubes), catheters (catheter tubes), medication tubes (tubes used for medication). A bodily fluid flows through the bodily fluid guide tube.

Drains may include cranial nerve, ear, nose and throat, respiratory, circulatory, mammary gland/endocrine, upper gastrointestinal, biliary, hepatopancreatic, urological, gynecological, and orthopedic drains. Cranial nerve drains may include ventricular drains, cisternal drains, epidural drains, subcutaneous drains, hematoma drains, lumbar drains, drains used after endoscopic brain surgery, and the like. Ear, nose and throat drains may include drains used after head and neck surgery, and the like. Respiratory drains may include chest drains, mediastinal drains, and the like. Cardiac drains may include pericardial drains, drains used after head and neck surgery, and the like. Breast and endocrine drains may include drains used after breast cancer surgery, mastitis drains, drains used after thyroid surgery, and the like. Drains for the upper gastrointestinal tract may include thoracic and mediastinal drains, cervical drains, abdominal drains, upper abdominal peritonitis drains, intra-abdominal abscess drains, drains used after gastric surgery, and the like. Biliary hepatopancreatic drains include percutaneous transhepatic gallbladder drains, percutaneous transhepatic biliary drains, liver abscess drains, endoscopic biliary drains, drains for acute pancreatitis, lower gastrointestinal retroperitoneal abscess drains, and rectal cancer surgery. drains, perianal abscess drains, and the like. Urinary drains may include drains used after general surgery, drains used after endoscopic surgery, drains used for percutaneous and transurethral approaches, and the like. Gynecological drains may include drains used after open surgery, drains used after endoscopic surgery, and the like. Orthopedic drains may include joint cavity drains and the like. In addition, other drains may include an incision drainage drain and the like.

Catheters may include angiographic catheters, balloon catheters, cardiac catheters, cerebrovascular catheters, catheters used for cancer catheter treatment, indwelling catheters, urethral catheters, and the like.

The dosing tube may include a tube or the like used in a dosing device (dosing system). The dosing device may include a dosing pump (TCI (Target Controlled Infusion) pump) or the like that directly controls the drug concentration in blood. The TCI pump controls the operation of the pump, adjusts the rate of drug administration, and controls the blood concentration of the drug to a target blood concentration.

FIG. 13 is a diagram illustrating introduction of bodily fluids including drugs and infusions (hereinafter also referred to as drugs and the like) to patient PA1 by TCI pump 10A. A bodily fluid containing a drug or the like is introduced from the TCI pump 10A to the patient PA1 through the medication tube 30A. Body fluid is also sent from patient PA1 to TCI pump 10A via medication tube 30A. That is, the TCI pump 10A adjusts the dosage and administration rate of the drug to the patient PA1, circulates bodily fluids with the patient PA1, and controls the concentration of the drug in the body of the patient PA1. With such a TCI pump 10A, for example, it is possible to implement a medication system that directly controls the drug concentration in the blood of the patient PA1.

The TCI pump 10A may have the same configuration as the drain sensor 10 except for the configuration related to the administration control of the drug administered to the patient PA1, for example, the configuration shown in FIG. good. The TCI pump 10A may sample the bodily fluid from the TCI pump 10A to the patient PA1 and measure the controlled component. In addition, the TCI pump 10A may sample the body fluid from the patient PA1 toward the TCI pump 10A and measure the component to be managed.

In the above embodiment, the adhesive layer 240 is provided between the porous sheet 220 and the affinity sheet 230A and the affinity sheet 230B in the channel 210, but the adhesive layer 240 may not be provided. . For example, the porous sheet 220, the affinity sheet 230A, and the affinity sheet 230B may be integrally formed. In this case, the channel 210 may be defined by, for example, MEMS (Micro Electro Mechanical Systems) technology.

For example, a material (for example, a sheet) corresponding to the affinity sheet 230B is recessed in a shape corresponding to the flow path 210 in the thickness direction (the direction in which the porous sheet 220 and the affinity sheet 230A are aligned with the affinity sheet 230B). The inside of the channel 210 (for example, the spaces 242, 243, and the space 245) may be defined by forming the concave portion. Then, the inside of the defined channel 210 is subjected to hydrophilic treatment, and the material corresponding to the affinity sheet 230B, the material corresponding to the porous sheet 220 (for example, a gas-permeable membrane sheet), and the material corresponding to the affinity sheet 230A. may be attached to form the entire flow path 210 . Hydrophilic treatment is treatment for imparting affinity to the liquid flowing through channel 210 . The gas-permeable membrane may have a non-affinity for the liquid to be sent.

Similarly, in the material (for example, sheet) corresponding to the porous sheet 220 and the affinity sheet 230A, the channel 210 is formed in the thickness direction (the direction in which the porous sheet 220 and the affinity sheet 230A and the affinity sheet 230B are arranged). The interior of the channel 210 (for example, spaces 242, 243, and 245) may be defined by forming recesses that are recessed in a shape corresponding to . Then, the entire channel 210 may be formed by attaching a material (for example, a sheet) corresponding to the affinity sheet 230B to the material corresponding to the porous sheet 220 and the affinity sheet 230A. The surface of the affinity sheet 230B facing the interior of the channel 210 may be subjected to a hydrophilic treatment.

In the above-described embodiment, the porous sheet 220 is arranged on the upper surface of the channel 210 and the affinity sheet 230B is arranged on the lower surface of the channel 210, but the reverse is also possible. That is, the porous sheet 220 and the affinity sheet 230A may be arranged on the lower surface of the channel 210, and the affinity sheet 230B may be arranged on the upper surface of the channel 210. Even in this case, it is considered that the same effects as in the present embodiment can be obtained.

In the above embodiment, the blood cell separation membrane 244 separates the sampling liquid sq into blood cell components and non-blood cell components, but is not limited to this. For example, the separation membrane may separate a liquid (for example, a chemical material) other than the sampling liquid sq into a plurality of components other than blood cell components and non-blood cell components.

Although the above embodiment discloses an example of liquid sampling, the embodiment is not limited to this. For example, it can be applied to applications such as liquid dispensing and dripping, in which liquid is discharged at a constant volume.

In the above embodiment, sampling is performed by the drainage sampling mechanism 110, but the drainage sampling mechanism 110 may be omitted. In this case, the liquid may be dropped directly into the channel 210 . Alternatively, the separation membrane may not be provided, and all of the dropped liquid may be the object of measurement. For example, it is possible to measure a liquid (of one type of component) that is not separated using the measurement light.

In the above embodiment, the use of a glass membrane as the blood cell separation membrane 244 is mainly exemplified, but other members may be used. For example, a positively charged film that can be charged and adsorbed to blood cells may be used, or a member having an adsorption mechanism other than charged adsorption may be used.

In the above embodiment, the data of each component to be managed in the sampling liquid sq is obtained in time series. In addition to these time-series data, time-series data of the total discharge amount of drain effluent Lq and sampling liquid sq may be acquired. The time-series data of the total discharge amount of drain fluid Lq may be obtained, for example, based on the output value of a sensor (for example, strain sensor) that measures the weight of the drain bag. The time-series data of the total discharge amount of the sampling liquid sq may be obtained by, for example, measuring the extraction amount of the sampling liquid sq each time by the drainage sampling mechanism 110 and integrating each time. The time-series data may also include data on the amount of drain fluid Lq and sampling fluid sq discharged per unit time.

In the above embodiment, the CPU 181 of the drain sensor 10 may calculate the concentration of amylase based on the amount of change in the absorbance of amylase. The amylase concentration data is an example of measurement data. For example, the correspondence information between the amount of change in absorbance of amylase and the concentration of amylase may be stored in a memory or the like, and the concentration of amylase may be derived based on this correspondence information. The CPU 181 of the drain sensor 10 may calculate the concentration of bilirubin based on the absorbance of bilirubin. Bilirubin concentration data is an example of measurement data. For example, correspondence information between bilirubin absorbance and bilirubin concentration may be stored in a memory or the like, and the bilirubin concentration may be derived based on this correspondence information. Corresponding information may be represented by a calibration curve.

In the above embodiment, the drain liquid sensor 10 and the drain liquid monitor 20 are configured as separate devices, but the drain liquid sensor 10 and the drain liquid monitor 20 are configured as devices having the same housing. good too.

Although the drain tube 30 is connected to the main tube 130 in the above embodiment, the main tube 130 may be part of the drain tube 30 .

In the above embodiment, the blood cell separation/enzyme reaction mechanism 150 of the drain sensor 10 may measure the blood concentration contained in the sampling liquid sq as the component to be managed. The blood concentration in the sampling liquid sq can be measured, for example, by irradiating the space 242 in which the blood cell separation membrane 244 to which blood cells are adsorbed is arranged with measurement light and receiving the scattered light. As the measurement light for measuring the blood concentration, for example, light having a peak wavelength of 660 nm or 850 nm may be used. That is, an LED 182B that emits infrared light may be used. In such measurements, the bodily fluid (eg, component to be managed) may include the body's blood cells (eg, the patient's venous blood). By measuring the patient's venous blood, the drain drainage sensor 10 can assess the patient's condition based on the characteristics of the blood.

In this way, the drainage management system 5 collects, separates, dispenses, analyzes, etc., the drainage liquid Lq discharged from the living body of the patient, and provides an index for considering medical treatment for the patient. can be provided to the user. Also, collection, separation, dispensing, analysis, etc. of the drain liquid Lq can be performed by the drain liquid sensor 10, which is one device.

In addition, it is assumed that the patient wears the drain tube 30 on the patient's body, for example, for about one week. The frequency of sampling the drain fluid Lq may be, for example, about once an hour, or about 170 times a week.

As described above, the measurement device (for example, the drain sensor 10) includes the porous membrane 246 (an example of the first porous membrane) into which the body fluid (for example, the sampling liquid sq2) is introduced, and the porous membrane 246 fixed to the body fluid. Blood cell separation that measures the characteristics of the mixture sq3 that reacts with the mixture sq3 produced by mixing a polymer that can be dissolved in water (for example, a water-soluble polymer 248) and the body fluid and the dissolved polymer, and the mixture sq3 that reacts with the reagent - Enzyme reaction mechanism 150 (an example of a measurement unit) may be provided.

This allows the measurement device to mix the body fluid with a polymer that is soluble in the body fluid (for example, the water-soluble polymer 248) to generate the liquid mixture sq3. As a result, the body fluid to be measured becomes more viscous, and the enzymatic reaction time can be lengthened. Therefore, the amount of change in absorbance can be reduced, and a higher concentration of the substance to be measured can be included in the measurement range. In addition, since the liquid mixture sq3 contains the water-soluble polymer 248, the concentration of amylase contained in the liquid mixture sq3 becomes relatively low (diluted), and the measurement range of the concentration of the substance to be measured can be expanded. In this way, the measurement device can expand the measurement range of the substance to be measured (for example, amylase) contained in the body fluid and measure the substance to be measured with high accuracy.

The measuring device may also include an affinity sheet 230B that has an affinity for body fluids and that is arranged to face the porous membrane 246 . Reagents may include first reagent 231 and second reagent 247 . A first reagent 231 may be applied (eg, coated) to the affinity sheet 230B. A second reagent 247 may be applied (eg, coated) to the porous membrane 246 .

As a result, the measurement device can first mix the body fluid introduced into the porous membrane 246 with the second reagent, and then react with the first reagent to generate the mixed solution sq3. Therefore, the measuring device can mix and react with the body fluid in a plurality of stages, and color the enzyme.

Also, the second reagent 247 may be dissolvably immobilized between the porous membrane 246 and the polymer (eg, water-soluble polymer 248).

As a result, the measuring device first mixes the body fluid and the polymer (for example, the water-soluble polymer 248), then mixes it with the second reagent to generate the mixed liquid sq3, and then reacts it with the first reagent 231. be able to. Therefore, the measuring device can cause the mixed liquid sq3, which simulates the state in which the body fluid is diluted, to react with the first reagent 231, and can expand the measurement range of the substance to be measured.

Moreover, the measuring device may include a CPU 181 (an example of an estimating unit). The CPU 181 may acquire correlation information indicating the correlation between the concentration of the component to be managed in the body fluid and the amount of change in absorbance (an example of a characteristic value). The CPU 181 may estimate the concentration of the component to be managed based on the amount of change in the measured absorbance based on the correlation information.

Thereby, the measuring device can refer to, for example, the correlation information indicating the correlation between the concentration of the component to be managed and the characteristic value (for example, the amount of change in absorbance) derived in advance. By including the correlation information between the high concentration range and the amount of change in absorbance in the correlation information, the measurement device can use the correlation information to derive the concentration of the measurement target over a wide range based on the change in absorbance.

Further, the correlation information may be represented by a calibration curve derived based on each value indicating the characteristic of the component to be managed with respect to each concentration of the component to be managed.

For example, an arbitrary measuring device obtains a plurality of sample points indicating the characteristic value of the controlled component with respect to the concentration of the controlled component, derives a certain correlation at the plurality of sample points, derives a calibration curve, and measures Let the device (for example, a drain discharge sensor) hold it. As a result, the measuring device can derive the concentration for the specific value of the component to be managed by a simple calculation using the calibration curve.

In addition, the blood cell separation/enzyme reaction mechanism 150 includes an LED 182 (an example of a light source) that emits measurement light to the mixture sq3 that has reacted with the reagent, and a photo sensor that receives scattered light obtained by scattering the measurement light at the porous membrane 246. A sensor 183 (an example of a light receiving unit) and a CPU 181 (an example of a measurement processing unit) that measures the characteristics of the liquid mixture sq3 based on scattered light may be provided.

Thereby, the measuring device can optically measure the properties of the liquid mixture sq3.

Further, the properties of the liquid mixture sq3 may include changes in the absorbance of the liquid mixture sq3.

Thereby, the measuring device can measure the properties of the liquid mixture sq3 from changes in absorbance.

The measurement device may also include a blood cell separation membrane 244 (an example of a separation membrane) that separates the component to be managed from the body fluid. Porous membrane 246 may introduce components to be managed separated by blood cell separation membrane 244 .

Thereby, the measuring device can separate the body fluid introduced into the space 242 by the separation membrane, for example. Therefore, the measurement device can use the measurement light to measure the component of the body fluid separated by the separation membrane. Therefore, even when measuring a body fluid containing a mixture of different components, the measuring device prevents the measurement of a mixture of different components, expands the measurement range of the concentration of components subject to management to the high concentration side, and controls Target components can be measured with high accuracy.

Also, controlled components may include blood, amylase, or bilirubin.

This allows the measuring device to measure various concentrations of enzyme components excreted by or introduced into the patient.

The measurement device may also include a channel 210 for feeding bodily fluid. At least part of the channel 210 includes a first region (region where the porous sheet 220 is arranged) having a plurality of fine holes 221 (an example of through holes) for maintaining the pressure in the channel 210 at atmospheric pressure. , a second region having affinity for body fluid (for example, regions where affinity sheets 230A and 230B are arranged), and a porous membrane 246 disposed between the first region and the second region and having affinity for body fluid. , and a blood cell separation membrane 244 (an example of a second porous membrane) disposed between the first region and the second region. A space 245 may be defined between the porous membrane 246 and the blood cell separation membrane 244 . The bodily fluid may be transferred from the blood cell separation membrane 244 to the porous membrane 246 by the force resulting from the affinity with the second region.

As a result, the measuring device and the flow path 210 can feed the bodily fluid by a force (for example, surface tension) caused by the affinity of the second region. The measuring device and the channel 210 allow air to pass through the fine holes 221 even if the channel 210 does not have an exhaust port, and the pressure inside the channel 210 is reduced to the atmospheric pressure outside the channel. can be maintained, and an increase in the pressure inside the flow path 210 can be suppressed. Therefore, the measuring device and the flow path 210 can easily transfer the bodily fluid even if the force caused by the affinity is relatively weak. In addition, since the measuring device and the channel 210 can send the liquid by the force caused by the affinity, the liquid can be sent without pressurizing the channel 210 .

In addition, the measuring device and the flow channel 210 can assist the liquid feeding and increase the liquid feeding power by the capillary force generated in the porous membrane 246 arranged inside the flow channel 210 . In addition, since the measuring device and channel 210 have a space 245 between the blood cell separation membrane 244 and the porous membrane 246, the body fluid is sent to the porous membrane 246 through the space 245. It can be separated into the 246 side and the blood cell separation membrane 244 side. Then, the body fluid reaching the porous membrane 246 side advances in the porous membrane 246 at a constant speed, and the amount of body fluid existing on the porous membrane 246 side can be kept constant. Therefore, the measurement device and channel 210 can stabilize the amount of liquid fed in channel 210 at a constant level.

Further, the measuring device can measure the characteristics of the body fluid stored in the porous membrane 246 by irradiating the mixed liquid sq3 with the measurement light. In this case, the size of the porous membrane 246 arranged in the space 243 is unchanged, and the liquid feeding amount and storage amount of the porous membrane 246 are constant. characteristics can be stably measured. Therefore, the measuring device can improve the stability of liquid transfer by the channel 210, and can reduce variations in measurement results.

In addition, the flow channel 210 of the measuring apparatus can realize the generation of the mixed solution sq3 simulating dilution of the object to be measured within one device. The channel 210 can realize the generation of the mixed solution sq3 that mimics dilution of the measurement target within one flow cell.

The measuring tape 200 may also include the flow path 210 described above. The channel 210 consists of a porous sheet 220 forming a first region, an affinity sheet 230A adjacent to the porous sheet 220 and forming part of the second region, and an affinity sheet 230B forming another part of the second region. , may be provided. Porous sheet 220 and affinity sheets 230A and 230B may have flexibility that allows bending in the direction in which porous sheet 220 and affinity sheets 230B are arranged (for example, the thickness direction of channel 210).

As a result, the measurement tape 200 has the functions and effects of the channel 210 . In addition, the measuring tape 200 is flexible and deformable, and can be easily formed into a tape shape. When the measuring tape 200 has a tape shape, it can be used repeatedly by providing a plurality of channels 210 . In addition, the measurement tape 200 sends out the portion of the flow path 210 that has been used once, and uses the unused flow path 210, so that the body fluid can be measured cleanly. It is possible to suppress the deterioration of the measurement accuracy.

In addition, the measurement method of the present embodiment includes a step of introducing body fluid into the porous membrane 246, a step of reacting the body fluid with the polymer soluble and fixed to the porous membrane 246 to dissolve the polymer, and a step of dissolving with the body fluid. a step of mixing the mixed solution sq3 with the polymer obtained, a step of reacting the mixed solution sq3 with the second reagent 247, and a step of measuring the properties of the mixed solution sq3 reacted with the second reagent 247. and may include

In addition, the drain drainage management system 5 can extract the components to be managed that affect the drain drainage from the drain tube to the outside. In addition, the drain management system 5 can measure the extracted component to be managed and derive measurement data based on the measurement results. In addition, the drain management system 5 displays the time-series data representing the chronological change of the measurement data on the display 21, so that the user (doctor/nurse, other medical personnel) can understand the characteristics of the drain. When evaluating, instead of (or in addition to) visual evaluation, evaluation can be performed based on time-series data. Therefore, the user can more objectively evaluate the recovery tendency of the patient than the evaluation based only on visual observation.

In addition, in the same way as with the drained fluid, the component to be managed that affects the body fluid other than the drained fluid can be extracted to the outside from the drain tube 30 . In addition, the extracted management target component can be measured, and measurement data based on the measurement results can be derived. In addition, by displaying the time-series data representing the temporal change of the measurement data on the display 21, when the user evaluates the characteristics of the bodily fluid, instead of visual evaluation (or in addition to visual evaluation) ), which can be evaluated based on time series data. Therefore, the user can more objectively evaluate the recovery tendency of the patient based on the data related to the body fluid than the evaluation based only on visual observation.

In addition, the drain management system 5 can measure, for example, the amount of enzyme discharged or introduced into the patient, the amount of bilirubin, or the amount of blood cells, which facilitates understanding of the patient's condition.

In addition, the drain management system 5 can easily separate blood cells and non-blood cells by utilizing the difference in adsorption force with the blood cell separation membrane 244 . In addition, by measuring the absorbance of non-blood cells, the drain drainage management system 5 can derive (eg, calculate) the concentration of non-blood cells whose correspondence with the absorbance is uniquely determined based on the absorbance.

In addition, the drain drainage management system 5 irradiates measurement light to each of the regions where the blood cell component stays (for example, the blood cell separation membrane 244) and the region where the non-blood cell component stays (for example, the porous membrane 246). By doing so, the characteristics of blood cells and non-blood cells can be distinguished and detected.

In addition, the drain drainage management system 5 causes the enzyme separated by the blood cell separation membrane 244 to react with the first reagent 231, and measures the absorbance of the reacted enzyme. Even in such a case, the enzyme can be colored and measured. Therefore, when the colored enzyme is irradiated with the measurement light, the enzyme can scatter the measurement light, and the photosensor 183 can receive the scattered light. Therefore, the drain drainage management system 5 can measure the absorbance of the enzyme and derive the concentration of the enzyme based on the absorbance even when the colorless enzyme is the component to be managed.

Also, the blood cell separation membrane 244 may be a glass membrane formed into a sheet by bundling glass fibers. In this case, the drain drainage management system 5 uses a glass membrane as the blood cell separation membrane 244, so that the necessary and sufficient amount of non-blood cells for measurement can be obtained compared to a monolithic membrane that cannot obtain sufficient non-blood cells due to its small pores. can secure the amount of In addition, since the drain drainage management system 5 uses a glass membrane as the blood cell separation membrane 244, unlike a cellulose membrane, it does not have holes, so blood cells and non-blood cells are prevented from passing through, and the capillary action of glass fibers, etc. , blood cells and non-blood cells can be preferably separated. In addition, the drain management system 5 uses the blood cell separation membrane 244 formed into a sheet by bundling glass fibers, so that the blood cell separation membrane 244 can be easily handled like a non-woven fabric.

Moreover, the drain liquid management system 5 has a drain liquid sampling mechanism 110 that can sample the drain liquid with a simple configuration, is excellent in portability, and is easy to carry. Thus, the patient does not have to remain in place during sampling, increasing the user's flexibility during sampling. In addition, the drain management system 5 can stabilize the amount of drain liquid present between the two points by keeping the distance between the two points on the main tube 130 unchanged during measurement. The amount of this drain fluid is the amount of one sampling. In addition, the drainage management system 5 allows drainage to pass when pressed by the first pressing member 115 and does not allow drainage to pass when not pressed by the first pressing member 115. sampling volume of drain effluent can be drained. Therefore, it is possible to prevent liquid from remaining in the sub-tube 133 . Therefore, the drain liquid management system 5 can prevent the drain liquid from being mixed with the previous sample in each sampling, and can derive measurement data with high measurement accuracy according to the sampling timing.

INDUSTRIAL APPLICABILITY The present disclosure is useful for a channel, a measuring tape, a measuring device, and the like that can measure a substance to be measured contained in bodily fluids with high accuracy by expanding the range of measurement of the substance to be measured.

5 drain drainage management system 10 drain drainage sensor 10A TCI pump 10z housing 10y through hole 20 drain drainage monitor 20z housing 21 display 22 graph 23 legend 24 meter 25 status marker 26 CPU
27 Memory 28 Wireless chip 30 Drain tube 30A Medication tube 40 Drain bag 41 Inflow tube 110 Drainage sampling mechanism 113, 114 Limiting member 113A, 114A, 115A Pressure unit 113B, 114B Partition plate 115 First pressure member 115B Pressure plate 130 Main Tube 130c Tube central portion 133 Subtube 133z Flow path 150 Blood cell separation/enzyme reaction mechanism 171 Feeding reel 172 Take-up reel 175 Motor 176, 177 Roller 180 Sensor unit 180z Housing 181 CPU
182, 182A, 182B LEDs
183 photo sensor 184 wireless chip 185 battery 186 pressurizing unit driving section 187 motor driving section 188 circuit board 200 measuring tape 210 channel 220 porous sheet 221 fine hole 222 through hole 230A, 230B affinity sheet 231 first reagent 240 Adhesive layer 241 Adhesive 242, 243, 245 Space 244 Blood cell separation membrane 246 Porous membrane 247 Second reagent 248 Water-soluble polymer L1, L2 Broken line Lq Drain drainage PA1 Patient sq, sq1, sq2 Sampling liquid sq3 Mixed liquid

Claims (8)

a first porous membrane into which body fluid is introduced;
an affinity sheet having an affinity for the body fluid and arranged to face the first porous membrane;
a polymer fixed to the first porous membrane and soluble in the bodily fluid;
a reagent that reacts with a mixed liquid produced by mixing the bodily fluid and the dissolved polymer;
a measuring unit that measures the properties of the mixed solution that has reacted with the reagent;
with
the reagent comprises a first reagent and a second reagent;
The first reagent is attached to the affinity sheet,
The second reagent is applied to the first porous membrane,
wherein the second reagent is dissolvably immobilized between the first porous membrane and the polymer;
measuring device. an estimating unit,
The estimation unit
Acquiring correlation information indicating the correlation between the concentration of the component to be managed in the bodily fluid and the characteristic value;
estimating the concentration of the component to be managed based on the characteristic value measured by the measuring unit based on the correlation information;
The measuring device according to claim 1 . The correlation information is represented by a calibration curve derived based on each value indicating the characteristic of the managed component with respect to each concentration of the managed component,
The measuring device according to claim 2 . The measurement unit
a light source that emits measurement light to the mixed solution that has reacted with the reagent;
Scattered light obtained by scattering the measurement light in the mixed liquid is received by a light receiving unit;
The measurement unit includes a measurement processing unit that measures the properties of the mixed liquid based on the scattered light.
The measuring device according to any one of claims 1-3 . The properties of the mixed solution include the amount of change in absorbance of the mixed solution,
The measuring device according to any one of claims 1-4 . A separation membrane that separates a component to be managed from the bodily fluid,
The first porous membrane introduces the component to be managed separated by the separation membrane.
The measuring device according to any one of claims 1-5 . The component to be managed includes blood, amylase or bilirubin,
The measuring device according to claim 6 . further comprising a channel for sending the bodily fluid,
at least a portion of the flow path,
a first region having a plurality of first through holes for maintaining the pressure in the channel at atmospheric pressure;
a second region having an affinity for the bodily fluid;
a first porous membrane disposed between the first region and the second region and having an affinity for the body fluid;
a second porous film disposed between the first region and the second region;
with
A space is defined between the first porous membrane and the second porous membrane,
The bodily fluid is sent from the second porous membrane to the first porous membrane by a force caused by affinity with the second region,
The measuring device according to any one of claims 1-7 .

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