Medical liquid delivery system

Abstract

A medical liquid delivery system (10) delivers a collection object (L) generated in a living body (B) to a medical bag (16) through a tube (14). The medical liquid delivery system (10) is provided with an occluding part (22) capable of blocking the circulation of the collection object (L) by occluding an intermediate part (143) of the tube (14). The medical liquid delivery system (10) further comprises a first state monitoring part (241) that monitors the state of the tube (14) at a first position (P1), and a second state monitoring part (242) that monitors the state of the tube (14) at a second position (P2). On the basis of the difference between a first state parameter at the first position (P1) and a second state parameter at the second position (P2), a control part (263) releases the blocked state of the tube (14) by the occluding part (22).

Description

Medical fluid delivery system

[0001] The present disclosure relates to a medical fluid delivery system.

[0002] Japanese Patent Application Laid-Open No. 2021-72926 discloses a urine measurement device capable of measuring the pressure of urine in the bladder of a living body. The urine measurement device includes a pressure sensor and a recording device. With a urinary catheter inserted into the bladder, the pressure in the urinary catheter is measured by the pressure sensor, and then the pressure value is recorded in the recording device.

[0003] Japanese Patent Application Laid-Open No. 2021-72926

[0004] Generally, urine whose pressure has been measured by a urine measurement device as described above is sent through a tube to a medical bag. However, if there is a downwardly bent portion in the middle of the tube connecting the urine measurement device and the medical bag, urine may accumulate at the bent portion, and it may not be possible to transfer the liquid from the bladder to the medical bag through the tube.

[0005] The present disclosure aims to solve the above-described problems.

[0006] (1) An aspect of the present disclosure is a medical fluid delivery system comprising a catheter, a tube connected to the catheter, and a medical bag connected to the tube, for delivering a sample, which is a liquid generated in a living body, through the catheter and the tube to the medical bag, wherein the tube has an inlet end connected to the catheter into which the sample is introduced, an outlet end connected to the medical bag into which the sample is delivered, and an intermediate portion provided between the inlet end and the outlet end, and the medical fluid delivery system is the A medical fluid delivery system comprising: a blocking section capable of blocking the flow of the sample to be collected through the tube by blocking the intermediate section; a first state monitoring section that monitors the state of the tube or the inside of the tube at a first position upstream of the blocking section in the intermediate section; a second state monitoring section that monitors the state of the tube or the inside of the tube at a second position downstream of the blocking section in the intermediate section; and a control unit that releases the blocking state of the tube by the blocking section based on a comparison value obtained by comparing the value of a first state parameter at the first position and the value of a second state parameter at the second position.

[0007] This medical fluid delivery system prevents the accumulation of the sample in the tube by opening the occlusion when the amount of sample to be collected increases, allowing the sample to be effectively delivered to the medical bag. Furthermore, because the sample is delivered to the medical bag according to the amount of sample generated, it is possible to avoid applying unnecessary negative pressure to the body.

[0008] (2) In the medical fluid delivery system described in (1) above, a control device including the control unit may be provided, and the control device may calculate the difference which is the comparison value, or the rate of change of the difference.

[0009] (3) In the medical fluid delivery system described in (1) or (2) above, each of the first state monitoring unit and the second state monitoring unit may be equipped with a pressure detection unit for detecting the pressure inside the tube.

[0010] This configuration allows for the effective detection of an increase in the amount of material being collected within a biological fluid pathway or tube by detecting changes in the pressure of the sampled material.

[0011] (4) In the medical fluid delivery system described in (1) or (2) above, each of the first state monitoring unit and the second state monitoring unit may be equipped with a deformation detection unit for detecting the amount of deformation of the tube wall.

[0012] This configuration allows for the effective detection of an increase in the amount of material to be collected within the biological flow path or tube by detecting the amount of deformation of the tube wall.

[0013] (5) In the medical fluid delivery system described in (1) or (2) above, the first state monitoring unit and the second state monitoring unit may each detect a change in the liquid level of the sample to be collected in the tube.

[0014] This configuration allows for the effective detection of an increase in the amount of material to be collected within a biological fluid pathway or tube by detecting changes in the liquid level inside the tube.

[0015] (6) In the medical fluid delivery system described in any one of (1) to (5) above, a pump device is provided which is connected to the tube and delivers the sample to be collected to the medical bag through the tube, and the occlusion portion may be provided in the pump device.

[0016] This configuration allows the tube to be blocked by a pump device used to deliver the sample.

[0017] (7) The medical fluid delivery system described in (6) above may have a console comprising the first state monitoring unit, the second state monitoring unit, and the pump device, wherein the console is positioned vertically above the medical bag.

[0018] This configuration allows the tube connecting the pump device and the medical bag to be positioned linearly along the vertical direction, effectively suppressing the accumulation of the sample within the tube.

[0019] (8) In the medical fluid delivery system described in (7) above, the console is positioned adjacent to the medical bag and has an opening that communicates with the tube and is open to the atmosphere, and in the environment in which the medical fluid delivery system is used, the opening and the console may be positioned at the same height in the direction of gravity.

[0020] This configuration allows for atmospheric venting at the same height as the console, enabling accurate detection of the sample's formation state. This allows the sample to be delivered to the medical bag at the appropriate time, regardless of the system's height.

[0021] (9) In the medical fluid delivery system described in any one of (1) to (8) above, the intermediate portion of the tube may be equipped with a flow rate measuring unit capable of measuring the flow rate of the substance to be collected.

[0022] This configuration allows the flow rate measurement unit to measure the flow rate of the sample being collected through the tube, thereby confirming the amount of the sample being transferred from the body to the medical bag.

[0023] (10) In the medical fluid delivery system described in (9) above, the flow rate measuring unit is capable of measuring the flow rate of the urine that is to be collected, and the catheter may be placed in the bladder of the living body.

[0024] This configuration allows the flow rate measurement unit to effectively measure the flow rate of urine.

[0025] (11) In the medical fluid delivery system described in (10) above, the control device may display on the display unit a first urine volume which is the flow rate per unit time based on the flow rate of the urine, and a second urine volume which is calculated based on the body weight of the living organism.

[0026] This configuration allows the display unit to effectively show both the first urine volume measured by the flow rate measurement unit and the second urine volume based on the body's weight.

[0027] (12) In the medical fluid delivery system described in (4) above, the intermediate portion of the tube has a detection portion in which the amount of deformation of the tube wall is detected by the deformation amount detection unit, and the hardness of the detection portion may be lower than the hardness of the introduction end and the outlet end.

[0028] This configuration makes it possible for the first and second state monitoring units to accurately detect deformation of the tube due to changes in the state of the sampled material inside the tube, even when the changes in the state of the sampled material inside the tube are small.

[0029] (13) In the medical fluid delivery system described in any one of (1) to (12) above, the tube may include a first connector connectable to the first state monitoring unit and a second connector connectable to the second state monitoring unit.

[0030] This configuration makes it easy to attach the first state monitoring unit to a first position on the tube by connecting the first state monitoring unit and the first connector to each other. It also makes it easy to attach the second state monitoring unit to a second position on the tube by connecting the second state monitoring unit and the second connector to each other.

[0031] (14) In the medical fluid delivery system described in any one of (1) to (13) above, the control device may include a calculation unit that estimates the intravesical pressure of the living body based on the difference between the first state parameter and the second state parameter.

[0032] This configuration allows the calculation unit to effectively estimate the intravesical bladder pressure of a living organism.

[0033] According to this disclosure, the medical fluid delivery system includes a occlusion section that can block the flow of the sample to be collected through the tube by closing the middle section of the tube. When the amount of sample to be collected in the tube increases, the occlusion section can be opened to suppress the accumulation of the sample to be collected in the tube, thereby enabling the sample to be effectively distributed to the medical bag.

[0034] Figure 1 is a diagram illustrating the configuration of a medical fluid delivery system according to an embodiment of the present disclosure. Figure 2 is an explanatory diagram illustrating the use of the medical fluid delivery system. Figure 3 is an explanatory diagram showing the configuration of the state monitoring unit, control device, and flow rate measuring unit. Figure 4 is a block diagram of the medical fluid delivery system. Figure 5 is an explanatory diagram relating to the attachment and detachment of the state monitoring unit and the tube. Figure 6A is a diagram illustrating the configuration of the flow rate measuring unit. Figure 6B is a diagram illustrating the configuration of the flow rate measuring unit according to a first modified example. Figure 6C is a diagram illustrating the configuration of the flow rate measuring unit according to a second modified example. Figure 7 is a first flowchart illustrating how to use the medical fluid delivery system. Figure 8 is a second flowchart illustrating how to use the medical fluid delivery system. Figure 9A is a diagram illustrating the configuration of the state monitoring unit according to a first modified example. Figure 9B is a diagram illustrating the configuration of the state monitoring unit according to a second modified example. Figure 9C is a diagram illustrating the configuration of the state monitoring unit according to a third modified example.

[0035] As shown in Figure 1, the medical fluid delivery system 10 according to this embodiment is a medical device for delivering a sample target L (see Figure 2), which is a liquid generated within a living body B (see Figure 2), to a medical bag 16 via a tube 14. As shown in Figure 2, the medical fluid delivery system 10 is used, for example, to deliver urine L1 from the bladder C in the living body B to the medical bag 16. The following describes the case in which the medical fluid delivery system 10 delivers urine L1 from the bladder C. Note that the sample target L that can be delivered by the medical fluid delivery system 10 is not limited to urine L1. The sample target L can be any liquid generated within the living body B, and examples of sample target L include intrapleural exudate (pleural fluid), cerebrospinal fluid, intraperitoneal exudate (ascites), blood, etc.

[0036] As shown in Figure 1, the medical fluid delivery system 10 comprises a catheter 12, a tube 14, a medical bag 16, a console 18, and a pump device 20.

[0037] The catheter 12 is a medical device that is placed inside the body B when in use to drain urine L1 from the bladder C into a medical bag 16 placed outside the body (see Figure 2). The catheter 12 comprises a hollow catheter body 121, a balloon 122 provided at the tip of the catheter body 121, and a hub 123 provided at the proximal end of the catheter body 121.

[0038] The tube 14 is flexible. The tube 14 has an inlet end 141, an outlet end 142, and an intermediate section 143. The inlet end 141 is located at the tip of the tube 14 in the extending direction and is open. A catheter 12 is connected to the inlet end 141. Urine L1 from the bladder C is introduced into the tube 14 from the catheter 12 through the inlet end 141.

[0039] The outlet end 142 is provided at the base end of the tube 14 in the extending direction and opens. The outlet end 142 is connected to the medical bag 16. The urine L1 introduced into the tube 14 is discharged to the medical bag 16 through the outlet end 142.

[0040] The intermediate section 143 is provided between the inlet end 141 and the outlet end 142. The intermediate section 143 includes a housing section 144. The housing section 144 is part of the intermediate section 143 and is housed inside the console 18.

[0041] The medical bag 16 is a closed bag configured as a urine collection bag. The medical bag 16 comprises a bag body 161 and an introduction tube 162. The medical bag 16 may be made of, for example, a resin material and may be equipped with a one-way valve (not shown) to prevent backflow of the sample to be collected L (urine L1). The introduction tube 162 is connected to the outlet end 142 of the tube 14. The urine L1 in the catheter 12 is introduced through the tube 14 into the bag body 161 from the introduction tube 162.

[0042] The console 18 is arranged adjacent to the medical bag 16. The console 18 is arranged vertically above the medical bag 16. The console 18 includes a housing 181, a display unit 182, and a power button 183. Note that the console 18 is not limited to being arranged vertically above the medical bag 16. For example, the console 18 may be arranged obliquely above or in parallel with the medical bag 16.

[0043] The housing 181 is formed in a box shape. Inside the housing 181, a housing portion 144 of the tube 14 is accommodated. The middle portion 143 of the tube 14 is taken out from the upper part of the housing 181 and exposed to the outside.

[0044] The display unit 182 is provided on the front surface of the housing 181. The display unit 182 includes a display D capable of displaying the monitoring results of the state monitoring unit 24 and the like. The display D may be a touch panel. The power button 183 is provided on the front surface of the housing 181. By operating the power button 183 by the user, the power supply to the display unit 182 and the pump device 20 can be switched.

[0045] The pump device 20 is connected to the middle portion 143 of the tube 14. The pump device 20 is, for example, a roller pump. The pump device 20 is attached to the housing portion 144 of the tube 14 and accommodated inside the housing 181. When power is supplied to the pump device 20 from a power source not shown, a liquid sending portion not shown rotates to sequentially press the tube 14, thereby sending the urine L1 in the tube 14 toward the medical bag 16.

[0046] As shown in FIG. 3, the medical liquid delivery system 10 further includes an occlusion portion 22, a state monitoring portion 24, a control device 26, and a flow rate measurement portion 28. Each of the occlusion portion 22, the state monitoring portion 24, the control device 26, and the flow rate measurement portion 28 is accommodated inside the housing 181 of the console 18. Note that the medical liquid delivery system 10 may not include the flow rate measurement portion 28. Also, the flow rate measurement portion 28 may be provided in the pump device 20. For example, based on the tube diameter of the tube 14 and the rotation amount (rotation speed) of the pump device 20, it is possible to calculate the flow rate of the sampling target L (urine L1) flowing through the tube 14.

[0047] The blocking part 22 is attached to the middle part 143 of the tube 14. When the pump device 20 is a roller pump, the blocking part 22 is the pump device 20 itself. The blocking part 22 is provided so as to be able to block the middle part 143 of the tube 14 and cut off the flow of urine L1 through the tube 14. When the pump device 20 is driven based on a control signal from a control part 263 described later, the blocking state of the tube 14 by the blocking part 22 is released. That is, in the present embodiment, the pump device 20 also serves as the blocking part 22.

[0048] Note that the blocking part 22 is not limited to the configuration provided in the pump device 20 that is a roller pump. For example, when the pump device 20 is not a roller pump, the blocking part 22 is provided separately from the pump device 20. For example, the blocking part 22 may be a clamp having two gripping parts and capable of gripping the tube 14 with the two gripping parts. The blocking part 22 may also be a valve device capable of blocking the middle part 143 of the tube 14. Further, the blocking part 22 may include a blocking member that approaches or separates from the tube 14 by the magnetic force of a magnet or the spring force of a spring, and the tube 14 is blocked by the blocking member that has approached the tube 14. Furthermore, the blocking part 22 may include a blocking member that approaches or separates from the tube 14 by power supply. Also, the blocking part 22 may have a blocking member that is rotatable toward the tube 14, and is configured to be able to approach or separate from the tube 14 by eccentrically setting the rotation center of the blocking member.

[0049] The state monitoring part 24 monitors the state change of urine L1 in the tube 14. The state monitoring part 24 is provided in the middle part 143 (accommodated part 144) of the tube 14 and is accommodated in the console 18. The state monitoring part 24 includes a first state monitoring part 241 and a second state monitoring part 242.

[0050] The first state monitoring part 241 is arranged at a first position P1 that is upstream of the blocking part 22 in the middle part 143 of the tube 14. The first state monitoring part 241 monitors the state of urine L1 in the tube 14 at the first position P1 of the tube 14. The first state monitoring part 241 detects the first state parameter of urine L1 at the first position P1.

[0051] The first state monitoring unit 241 includes a first pressure detection unit 251. The first pressure detection unit 251 detects pressure changes in urine L1 in the tube 14 at a first position P1. The first state parameter is the first pressure of urine L1 at the first position P1. The first state monitoring unit 241 is detachable from a first connector 301 provided on the middle section 143 (first position P1) of the tube 14 (see Figure 5). By connecting the first state monitoring unit 241 and the first connector 301 to each other, the first state monitoring unit 241 can be attached to the first position P1 of the tube 14. The first pressure detection unit 251 includes an opening 145. The opening 145 is housed inside the console 18 and can be opened to the atmosphere. Pressure changes in urine L1 can be caused, for example, by pressure changes in the organs surrounding the bladder C (abdominal cavity), or by pressure changes within the tube 14 and catheter 12 (device).

[0052] The second state monitoring unit 242 is positioned at a second position P2 in the middle section 143 of the tube 14, downstream of the occlusion section 22. The second state monitoring unit 242 monitors the state of the urine L1 inside the tube 14 at the second position P2. The second state monitoring unit 242 detects a second state parameter of the urine L1 at the second position P2.

[0053] The second state monitoring unit 242 includes a second pressure detection unit 252. The second pressure detection unit 252 detects pressure changes of urine L1 in the tube 14 at the second position P2. The second state parameter is the second pressure of urine L1 at the second position P2. The second state monitoring unit 242 is detachable from the second connector 302 provided on the middle section 143 (second position P2) of the tube 14. By connecting the second state monitoring unit 242 and the second connector 302 to each other, the second state monitoring unit 242 can be attached to the second position P2 of the tube 14.

[0054] As shown in Figure 4, the control device 26 comprises an arithmetic unit 260, a storage unit 264, and a communication unit 265. The arithmetic unit 260 is composed of a processor, such as a CPU (Central Processing Unit) or a GPU (Graphics Processing Unit), i.e., a processing circuit.

[0055] The calculation unit 260 includes a state detection unit 261, a state acquisition unit 262, and a control unit 263. The state detection unit 261, the state acquisition unit 262, and the control unit 263 can be realized by the calculation unit 260 executing a program stored in the storage unit 264.

[0056] Furthermore, at least a portion of the state detection unit 261, the acquisition unit 262, and the control unit 263 may be implemented using integrated circuits such as ASICs (Application Specific Integrated Circuits) and FPGAs (Field-Programmable Gate Arrays). Alternatively, at least a portion of the state detection unit 261, the acquisition unit 262, and the control unit 263 may be composed of electronic circuits including discrete devices.

[0057] The storage unit 264 is composed of a volatile memory (not shown) and a non-volatile memory (not shown). Examples of volatile memory include RAM (Random Access Memory). The volatile memory is used as the working memory of the processor and temporarily stores data necessary for processing or calculation. Examples of non-volatile memory include ROM (Read Only Memory) and flash memory. The non-volatile memory is used as storage memory and stores programs, tables, maps, etc. At least a part of the storage unit 264 may be provided in the processor, integrated circuit, etc. as described above.

[0058] The state detection unit 261 detects changes in the state of the urine L1 inside the tube 14. The state detection unit 261 receives detection data from the first state monitoring unit 241 and the second state monitoring unit 242, respectively.

[0059] The state detection unit 261 calculates a comparison value by comparing the value of the first state parameter (first pressure) detected by the first state monitoring unit 241 with the value of the second state parameter (second pressure) detected by the second state monitoring unit 242. For example, it detects (calculates) the difference, which is the comparison value between the first pressure detected by the first state monitoring unit 241 and the second pressure detected by the second state monitoring unit 242. In this embodiment, the difference between the first state parameter and the second state parameter is the differential pressure.

[0060] The acquisition unit 262 acquires difference data between the first state parameter and the second state parameter obtained by the state detection unit 261. The storage unit 264 stores the difference data acquired by the acquisition unit 262. The control unit 263 can release the blockage state of the tube 14 by the occlusion unit 22. The control unit 263 analyzes the difference data acquired by the acquisition unit 262 and stored in the storage unit 264 and outputs it to the display unit 182. The difference data analyzed by the control unit 263 is output to the communication unit 265, and from the communication unit 265 it is output to the external communication unit 266. Based on the difference data received from the acquisition unit 262, the control unit 263 controls the flow of urine L1 by controlling the pump device 20. That is, the control unit 263 can output a control signal to the pump device 20 for driving control of the pump device 20. Note that the calculation unit 260 of the control device 26 is not limited to calculating the difference between the value of the first state parameter and the value of the second state parameter. For example, the calculation unit 260 may calculate the rate of change of the difference between the first state parameter and the second state parameter.

[0061] As shown in Figure 3, the flow rate measuring unit 28 is provided in the intermediate section 143 of the tube 14. The flow rate measuring unit 28 can measure the flow rate of urine L1, which is the sample to be collected, flowing through the intermediate section 143. The flow rate measuring unit 28 is located upstream of the first state monitoring unit 241 in the intermediate section 143. However, the flow rate measuring unit 28 is not limited to being located upstream of the first state monitoring unit 241. For example, the flow rate measuring unit 28 may be located downstream of the first state monitoring unit 241, or downstream of the pump device 20. Furthermore, as described above, by monitoring the driving state of the pump device 20 using the flow rate measuring unit 28, it is possible to convert this into the flow rate of urine L1, which is the sample to be collected. In that case, the flow rate measuring unit 28 may not be necessary.

[0062] As shown in Figure 6A, the flow rate measuring unit 28 includes a measuring unit 281. The measuring unit 281 includes a restrictor 282 and a branching passage 283. The diameter of the restrictor 282 is smaller than the diameter of the intermediate section 143. The branching passage 283 is a passage that branches off from the intermediate section 143. The branching passage 283 is a passage that connects the upstream side of the restrictor 282 to the restrictor 282. The flow rate measuring unit 28 can measure the flow rate of urine L1 using the principle of a Venturi tube. The flow rate of urine L1 (first urine volume) measured by the flow rate measuring unit 28 is acquired by the acquisition unit 262 of the control device 26. The first urine volume of urine L1 measured by the flow rate measuring unit 28 is displayed on the display unit 182. In the calculation unit 260, the urine volume (second urine volume) is calculated based on the body weight of the living organism B. For example, the second urine volume is calculated based on data previously stored in the storage unit 264. The second urine volume is displayed on the display unit 182 along with the first urine volume.

[0063] The flow rate measuring unit 28 is not limited to being composed of a measuring unit 281 having a throttling section 282 and a branching passage 283. For example, the flow rate measuring unit 28A according to the first modified example shown in Figure 6B includes a dripping device 36 provided in the intermediate section 143 of the tube 14. The dripping device 36 includes a cylindrical section 361 and a dripping section 362. Inside the cylindrical section 361 is a dripping chamber 363 that communicates with the tube 14. The inner diameter of the cylindrical section 361 is larger than the diameter of the intermediate section 143. The dripping section 362 is provided at the connection point between the upper part of the cylindrical section 361 and the tube 14. The dripping section 362 is positioned upstream of the cylindrical section 361. The dripping section 362 restricts the flow rate of urine L1 flowing from the tube 14 to the dripping device 36 and drips a predetermined amount of liquid into the dripping chamber 363. The flow rate of urine L1 can be calculated based on the number of urine droplets L1 per unit time.

[0064] The flow rate measuring unit 28B according to the second modified example shown in Figure 6C is provided on the pump device 20. The flow rate measuring unit 28B is calculated based on the amount of urine L1 delivered by the fluid delivery member 381 of the pump device 20. Specifically, when the pump device 20 is driven and the fluid delivery member 381 rotates, the flow rate of urine L1 can be calculated based on the amount of urine L1 delivered per rotation of the fluid delivery member 381 (urine volume), which has been calculated in advance. Alternatively, the flow rate of urine L1 may be calculated by measuring the weight of the medical bag 16 into which the urine L1 is introduced.

[0065] The medical fluid delivery system 10 is used as follows:

[0066] First, the catheter 12 and the medical bag 16 are connected via the tube 14. Specifically, the hub 123 of the catheter 12 and the inlet end 141 of the tube 14 are connected to each other. The outlet end 142 of the tube 14 and the inlet tube 162 of the medical bag 16 are connected to each other. With the catheter 12 and the medical bag 16 connected via the tube 14, the preparation of the catheter 12 is complete (Step S1 in Figure 7). Next, as shown in Figure 2, the tip of the catheter 12 is inserted into the bladder C of the patient B who is lying on bed A (Step S2 in Figure 7). The tip of the catheter 12 is left in the bladder C through the urethra (not shown). Specifically, the tip of the catheter body 121 and the balloon 122 are positioned inside the bladder C. If urine L1 has accumulated in the bladder C (Step S3: YES), the urine L1 in the bladder C is drained into the medical bag 16 through the catheter 12 and tube 14 (S4). After Step S4, proceed to Step S5.

[0067] On the other hand, if there is no urine L1 in the bladder C (step S3: NO in Figure 7), the process proceeds to step S5. In step S5, as shown in Figure 1, the intermediate portion 143 of the tube 14 is set in the pump device 20 inside the console 18. At this time, the intermediate portion 143 of the tube 14 is blocked by the occlusion portion 22 of the pump device 20. As shown in Figure 2, the console 18 and medical bag 16 of the medical fluid delivery system 10 are placed below the bed A on which the patient (living body B) is lying. At this time, in the environment in which the medical fluid delivery system 10 is used, the console 18 is positioned vertically above the medical bag 16. In the direction of gravity, the opening portion 145 and the console 18 are positioned at the same height.

[0068] Next, as shown in Figure 1, when the user operates the power button 183, power is supplied to the display unit 182, etc., of the console 18 from a power source (not shown). With the tube 14 open to the atmosphere through the opening 145, the zero point is set in the calculation unit 260 of the control device 26 (step S6 in Figure 7). This pressure value (atmospheric pressure) when open to the atmosphere becomes the reference pressure. At this time, the communication between the first position P1 and the second position P2 in the middle part 143 of the tube 14 is blocked by the closure unit 22 of the pump device 20 (see Figure 3). Note that it is not limited to the case where the opening 145 and the console 18 are located at the same height. For example, the opening 145 and the console 18 may be located at different heights.

[0069] The state monitoring unit 24 monitors and detects the state inside the tube 14 at the intermediate section 143 of the tube 14 (step S7 in Figure 7). Specifically, the first state monitoring unit 241 detects the pressure inside the tube 14 at the first position P1 (upstream side of the pump device 20) of the intermediate section 143 as the first pressure. The second state monitoring unit 242 detects the pressure inside the tube 14 at the second position P2 (downstream side of the pump device 20) of the intermediate section 143 as the second pressure. The pressure of the urine L1 at the first position P1 detected by the first state monitoring unit 241 (first pressure) and the pressure at the second position P2 detected by the second state monitoring unit 242 (second pressure) are output to the state detection unit 261 of the control device 26. The state detection unit 261 detects the difference (differential pressure) between the first pressure and the second pressure. When there is no urine L1 accumulated in the bladder C, the first pressure and the second pressure become almost the same, and the difference between the first pressure and the second pressure becomes almost negligible.

[0070] When urine L1 begins to accumulate in the bladder C, the first pressure inside the tube 14 rises through the catheter 12 from the middle section 143 of the tube 14 to the first state monitoring unit 241 located before the pump device 20 (first position P1). At this time, the occlusion section 22 blocks the flow of urine L1 downstream of the pump device 20. Therefore, in the state where the tube 14 is blocked by the occlusion section 22, the second pressure at the second position P2 is close to the pressure when open to the atmosphere, i.e., a gauge pressure of 0, and is not affected by the generation of urine L1. As the first pressure becomes larger than the second pressure, the difference between the first pressure and the second pressure increases. The difference data obtained by the state detection unit 261 is output from the state detection unit 261 as an electrical signal to the acquisition unit 262 and stored in the storage unit 264.

[0071] Based on the differential data stored in the memory unit 264, the control unit 263 determines whether the blockage state of the tube 14 by the blockage unit 22 of the pump device 20 can be released (step S8 in Figure 7). Specifically, the control unit 263 determines whether the differential data is greater than or equal to a preset differential threshold. If the differential data is greater than or equal to the differential threshold, it means that a predetermined amount or more of urine L1 has accumulated in the bladder C. Therefore, if it is determined that the differential data is greater than or equal to the differential threshold, the control unit 263 operates the blockage unit 22 because the driving conditions for the pump device 20 are met (step S8: YES). On the other hand, if the differential data is less than the differential threshold, it means that the amount of urine in the bladder C is less than a predetermined value. Therefore, if it is determined that the differential data is less than the differential threshold, the driving conditions for the pump device 20 are not met (step S8: NO in Figure 7), so the control unit 263 maintains the blockage of the tube 14 by the blockage unit 22 and returns to step S7. As a result, the state monitoring unit 24 continues to monitor the pressure of the urine L1 in the tube 14.

[0072] For example, the driving conditions for the pump device 20 may be determined by setting a certain value as a differential threshold and comparing it with the pressure value, or the driving conditions for the pump device 20 may be determined by comparing the change in pressure per unit time and based on the comparison result. In this case, the differential data can be used to determine that urine L1 has been produced when the first pressure increases in the positive direction per unit time. This prevents malfunction of the pump device 20 in cases where, for example, the second pressure is 0 or less and urine L1 has not been produced, but for some reason the first pressure is detected to be higher than the second pressure.

[0073] In step S8, if the driving conditions for the pump device 20 are met, the control unit 263 outputs a control signal to the pump device 20 (step S9 in Figure 7). By driving the pump device 20, the blockage state of the intermediate section 143 by the occlusion section 22 is released. The first position P1 and the second position P2 in the intermediate section 143 of the tube 14 become connected. As the pump device 20 is driven, the urine L1 that had been flowing up to the first position P1 flows to the second position P2 and is then introduced into the medical bag 16 via the introduction tube 162 of the medical bag 16. Even if there is a downwardly curved portion in the intermediate section 143 of the tube 14 and liquid (urine L1) accumulates in the curved portion, the driving of the pump device 20 forces the urine L1 through the tube 14 towards the medical bag 16. After the pump device 20 is activated, it is determined whether or not to complete the delivery of urine L1 from the bladder C to the medical bag 16 by the medical fluid delivery system 10 (step S10).

[0074] If it is determined that a predetermined amount of urine L1 has been introduced into the medical bag 16 (step S10: YES), the control unit 263 stops the operation of the pump device 20 (step S11). By stopping the operation of the pump device 20, the delivery of urine L1 from the bladder C to the medical bag 16 stops. On the other hand, if it is determined that a predetermined amount of urine L1 has not been introduced into the medical bag 16 (step S10: NO), the process returns to step S7. As a result, the condition monitoring unit 24 continues to monitor the pressure of urine L1 in the tube 14.

[0075] Then, after a predetermined amount of urine L1 has been collected in the medical bag 16, the pump device 20 stops operating (step S11). The user operates the power button 183 to turn off the power to the console 18 and removes the catheter 12 from the bladder C of the living organism B.

[0076] Next, we will explain the case where the pressure in the tube 14 inside the bladder C exceeds a predetermined value, as determined by the condition monitoring unit 24, with reference to Figure 8. Steps S1 to S7 are the same as the flowchart of the medical fluid delivery system 10 described above (Figure 7), so a detailed explanation will be omitted.

[0077] As shown in Figure 8, the condition monitoring unit 24 monitors the condition inside the tube 14, and the control unit 263 determines whether the pressure inside the tube 14 exceeds the pressure limit (step S20 in Figure 8). Specifically, the control unit 263 determines whether the pressure data is above a preset pressure limit threshold. If it is determined that the pressure data is above the pressure limit threshold, it is considered that the intravesical pressure in the bladder C of living organism B is high. If it is determined that the pressure inside the tube 14 exceeds the pressure limit (step S20: YES), the control unit 263 outputs a control signal to the pump device 20 to drive the pump device 20 (step S21). The drive of the pump device 20 releases the blockage state of the tube 14 by the occlusion unit 22. The first position P1 and the second position P2 are connected in the intermediate section 143 of the tube 14. As the urine L1 in the bladder C flows through the intermediate section 143 to the medical bag 16, the intravesical pressure in the bladder C decreases, and consequently, the pressure inside the tube 14 decreases. After the pump device 20 is activated, the condition monitoring unit 24 monitors the pressure of the urine L1 inside the tube 14 (step S7).

[0078] On the other hand, if the control unit 263 determines that the pressure data is below the upper pressure threshold (step S20: NO), the control unit 263 determines whether or not the driving conditions for the pump device 20 are met (step S8). Steps S8 onward are the same as steps S8 onward in the flowchart of the medical fluid delivery system 10 described above, so a detailed explanation is omitted.

[0079] In the medical fluid delivery system 10, the difference (comparison value, differential pressure) between the first pressure (first state parameter) detected by the first state monitoring unit 241 and the second pressure (second state parameter) detected by the second state monitoring unit 242 reflects the state of urine L1 storage in the bladder C. Therefore, it can be used as a state parameter for detecting the state of the body cavity (bladder C) where the catheter 12 is placed.

[0080] For example, if the catheter 12 is placed in the bladder C and the tube 14 is blocked by the occlusion section 22, the first state parameter (first pressure) of the first state monitoring unit 241 changes as the amount of urine L1 increases, while the second state parameter (second pressure) of the second state monitoring unit 242 does not change. Therefore, the first state parameter (first pressure) can be used to detect the intravesical pressure in the bladder C. When the pump device 20 is driven to open the occlusion section 22 and deliver the urine L1, pressure changes occur in both the first and second pressures. In this case, it is possible to estimate the intravesical pressure based on the state parameter (pressure value) immediately before driving the pump device 20, or the difference (differential pressure) between the first and second state parameters when the pump device 20 is stopped.

[0081] Bladder pressure is related to the intra-abdominal pressure of the body B, and since bladder pressure increases when the kidneys are compressed, a correlation with acute kidney injury has been pointed out. Therefore, by analyzing the changes in bladder pressure estimated using the state parameters detected by the state monitoring unit 24 and the changes in urine volume (first urine volume) detected by the flow rate measurement unit 28 in the calculation unit 260, the control device 26 can determine whether or not there is an impact on the kidney's renal function. Note that the determination of whether or not there is an impact on the kidney's renal function may be made by the control device 26, or the user may make a judgment based on the estimated changes in bladder pressure and urine volume.

[0082] This embodiment provides the following effects.

[0083] As shown in Figure 1, the medical fluid delivery system 10 includes a occlusion unit 22 capable of blocking the flow of the sample to be collected L in the tube 14, a first state monitoring unit 241 that monitors the state inside the tube 14 at a first position P1, and a second state monitoring unit 242 that monitors the state inside the tube 14 at a second position P2.

[0084] With this configuration, when the amount of material to be collected L in the tube 14 increases, the occlusion section 22 is opened, which suppresses the accumulation of material to be collected L in the tube 14 and allows the material to be effectively distributed to the medical bag 16. In addition, since the material to be collected L is delivered to the medical bag 16 according to the amount of material to be collected L generated, it is possible to avoid applying unnecessary negative pressure load to the body B.

[0085] As shown in Figure 3, the first state monitoring unit 241 and the second state monitoring unit 242 each include a first pressure detection unit 251 and a second pressure detection unit 252, respectively, which detect the pressure of the sampled object L inside the tube 14.

[0086] With this configuration, the first pressure detection unit 251 and the second pressure detection unit 252 detect changes in the pressure of the sampled substance L (urine L1), thereby effectively detecting an increase in the sampled substance L within the urinary tract or tube 14 of the living body B.

[0087] The system includes a pump device 20 connected to the tube 14 for delivering the sample L to the medical bag 16. A occlusion section 22 is provided on the pump device 20. With this configuration, the tube 14 can be occluded by the pump device 20 for delivering the sample L.

[0088] As shown in Figure 1, the system has a console 18 equipped with a first state monitoring unit 241, a second state monitoring unit 242, and a pump device 20. The console 18 is positioned vertically above the medical bag 16.

[0089] With this configuration, the tube 14 connecting the pump device 20 and the medical bag 16 can be arranged in a straight line along the vertical direction, thereby effectively suppressing the accumulation of the sampled material L within the tube 14.

[0090] The console 18 is positioned adjacent to the medical bag 16. The tube 14 communicates with an open section 145 that is open to the atmosphere. In the environment in which the medical fluid delivery system 10 is used, the open section 145 and the console 18 are positioned at the same height in the direction of gravity.

[0091] With this configuration, the opening 145 allows for ventilation to the atmosphere at the same height as the console 18, enabling accurate detection of the generation state of the sample target L. This allows the sample target L to be delivered to the medical bag 16 at the appropriate timing, regardless of the height of the medical fluid delivery system 10.

[0092] As shown in Figure 3, the intermediate portion 143 of the tube 14 is equipped with a flow rate measuring unit 28 capable of measuring the flow rate of the sampled material L.

[0093] With this configuration, the amount of sample material L being sent from the living body B to the medical bag 16 can be confirmed by measuring the flow rate of the sample material L flowing through the tube 14 using the flow rate measuring unit 28.

[0094] The flow rate measuring unit 28 is capable of measuring the flow rate of urine L1, which is the sample to be collected, and the catheter 12 is placed inside the bladder C of the living body B. With this configuration, the flow rate measuring unit 28 can effectively measure the flow rate of urine L1.

[0095] As shown in Figure 4, the control device 26 displays on the display unit 182 the first urine volume, which is the flow rate per unit time based on the flow rate of urine L1, and the second urine volume, which is calculated based on the body weight of the organism B. With this configuration, the display unit 182 can effectively confirm the first urine volume measured by the flow rate measurement unit 28 and the second urine volume based on the body weight of the organism B.

[0096] As shown in Figure 3, the tube 14 includes a first connector 301 that can be connected to the first state monitoring unit 241 and a second connector 302 that can be connected to the second state monitoring unit 242. With this configuration, the first state monitoring unit 241 can be easily attached to the first position P1 of the tube 14 by connecting the first state monitoring unit 241 and the first connector 301 to each other. The second state monitoring unit 242 can be easily attached to the second position P2 of the tube 14 by connecting the second state monitoring unit 242 and the second connector 302 to each other.

[0097] As shown in Figure 4, the control device 26 may include a calculation unit 260 that estimates the intrabladder pressure of living organism B based on the difference between a first state parameter and a second state parameter. With this configuration, the calculation unit 260 can effectively estimate the intrabladder pressure of living organism B.

[0098] The state monitoring unit 24 is not limited to being composed of a first pressure detection unit 251 and a second pressure detection unit 252 capable of monitoring changes in the state inside the tube 14. The state monitoring unit 24A according to the first modified example shown in Figure 9A comprises a first state monitoring unit 241A and a second state monitoring unit 242A. The first state monitoring unit 241A includes a first deformation amount detection unit 391.

[0099] The first deformation detection unit 391 detects the amount of deformation of the tube wall 40 of the tube 14 at the first position P1. The first deformation detection unit 391 is attached to the outer circumference of the tube 14. The first deformation detection unit 391 presses the tube wall 40 of the tube 14 radially inward, causing elastic deformation. The first deformation detection unit 391 detects the repulsive force of the tube 14 radially outward. The first deformation detection unit 391 is, for example, a strain sensor 42 capable of detecting the amount of deformation of the tube wall 40.

[0100] The second deformation detection unit 392 detects the amount of deformation of the tube wall 40 of the tube 14 at the second position P2. The second deformation detection unit 392 is attached to the outer circumference of the tube 14. The second deformation detection unit 392 presses the tube wall 40 of the tube 14 radially inward, causing elastic deformation. The second deformation detection unit 392 detects the repulsive force of the tube 14 radially outward. The second deformation detection unit 392 is, for example, a strain sensor 42 capable of detecting the amount of deformation of the tube wall 40.

[0101] When the intermediate portion 143 of the tube 14 is blocked by the occlusion portion 22, the tube 14 is pushed radially outward by the pressure of the urine L1 at the first position P1. The tube wall 40 of the tube 14 at the first position P1 is elastically deformed radially outward. The first deformation amount detection unit 391 detects the first radially outward deformation amount of the tube 14 at the first position P1. In the blocked state of the intermediate portion 143, urine L1 does not flow to the second position P2, so the tube wall 40 of the tube 14 at the second position P2 does not elastically deform radially outward. That is, the second deformation amount of the tube 14 detected by the second deformation amount detection unit 392 is approximately 0.

[0102] The intermediate portion 143 of the tube 14 may also include detectable portions (not shown) whose deformation is detected by the first state monitoring unit 241A and the second state monitoring unit 242A. The multiple detectable portions are areas where the amount of deformation of the tube wall 40 is detected by the first deformation amount detection unit 391 and the second deformation amount detection unit 392, respectively. The hardness of each detectable portion is lower than the hardness of other parts of the tube 14. Specifically, the hardness of each detectable portion is lower than the hardness of the inlet end 141 and the outlet end 142 of the tube 14. With this configuration, even if the change in the state of the urine L1 (collection target L) inside the tube 14 is small, the first state monitoring unit 241A and the second state monitoring unit 242A can accurately detect the deformation of the tube 14 due to the change in the state inside the tube 14 by each detectable portion.

[0103] The first deformation amount of the tube 14 detected by the first deformation amount detection unit 391 and the second deformation amount of the tube 14 detected by the second deformation amount detection unit 392 are output to the state detection unit 261. The state detection unit 261 calculates the difference between the first deformation amount and the second deformation amount.

[0104] The first modification produces the following effects:

[0105] As shown in Figure 9A, the first state monitoring unit 241A and the second state monitoring unit 242A each include a first deformation amount detection unit 391 and a second deformation amount detection unit 392 that detect the amount of radial deformation of the tube wall 40 of the tube 14.

[0106] With this configuration, the state monitoring unit 24A can detect the amount of deformation of the tube wall 40 of the tube 14, thereby effectively detecting an increase in the amount of sample material L inside the urinary tract of the living organism B or inside the tube 14.

[0107] The state monitoring unit 24B according to the second modified example shown in Figure 9B includes a detection unit 25B. The detection unit 25B is provided in the dripping device 36B. The dripping device 36B includes a cylindrical portion 361B and a dripping portion 362B. Inside the cylindrical portion 361B is a dripping chamber 363B that communicates with the tube 14. The dripping portion 362B restricts the flow rate of urine L1 flowing from the tube 14 to the dripping device 36B. The detection unit 25B is attached to the outside of the outer peripheral wall 364B of the cylindrical portion 361B. The detection unit 25B is, for example, a pressure sensor. The detection unit 25B can detect radially outward pressure applied to the outer peripheral wall 364B. When urine L1 is introduced into the dripping chamber 363B of the cylindrical portion 361B and the pressure inside the dripping chamber 363B rises, the detection unit 25B can detect the pressure of the urine L1. The detection unit 25B is not limited to a pressure sensor. For example, the detection unit 25B may be a sensor capable of detecting the radial distance between the outer walls 364B of the cylindrical portion 361B. The detection unit 25B may also be a strain sensor, optical sensor, or ultrasonic sensor capable of detecting the amount of radial deformation of the outer walls 364B of the cylindrical portion 361B. The state monitoring unit 24B is not limited to being provided at the first position P1 of the tube 14. For example, the state monitoring unit 24B may be provided at both the first position P1 and the second position P2 of the tube 14.

[0108] The state monitoring unit 24C according to the third modified example shown in Figure 9C comprises a first state monitoring unit 241C and a second state monitoring unit 242C. The first state monitoring unit 241C and the second state monitoring unit 242C are respectively provided at branching sections 44 located at first position P1 and second position P2 in the intermediate section 143 of the tube 14. The diameter of the branching section 44 is smaller than the diameter of the intermediate section 143. Each of the first state monitoring unit 241C and the second state monitoring unit 242C detects changes in the liquid level of urine L1 inside the tube 14. Specifically, each of the first state monitoring unit 241C and the second state monitoring unit 242C detects the liquid level height H, which is the change in the liquid level of urine L1 flowing into the branching section 44. Each of the first state monitoring unit 241C and the second state monitoring unit 242C is an optical sensor 46 capable of optically detecting the liquid level height H of urine L1.

[0109] It is preferable to provide one or more pairs of optical sensors 46 for detecting the liquid level H in each branch section 44. However, the first state monitoring unit 241C and the second state monitoring unit 242C are not limited to being composed of optical sensors 46. The first state monitoring unit 241C and the second state monitoring unit 242C only need to be able to detect changes in the liquid level of urine L1 in the branch section 44, and for example, the first state monitoring unit 241C and the second state monitoring unit 242C may be ultrasonic sensors, magnetic sensors, strain sensors, etc.

[0110] The liquid level height H at the first position P1 and the liquid level height H at the second position P2 are output to the state detection unit 261, respectively. The difference between the two liquid level heights H is detected and output as difference data to the control unit 263.

[0111] According to the third modified example, by detecting changes in the liquid level (liquid level height H) of urine L1 in the tube 14 using the first state monitoring unit 241C and the second state monitoring unit 242C respectively, an increase in urine L1 in the urinary tract of living organism B or in the tube 14 can be effectively detected.

[0112] While this disclosure has been described in detail, it is not limited to the individual embodiments described above. These embodiments can be added, replaced, modified, partially deleted, etc., in any way that does not depart from the gist of this disclosure or from the intent of this disclosure derived from the claims and their equivalents. These embodiments can also be implemented in combination. For example, the order of operations and processes in the embodiments described above are given as examples only and are not limited thereto. The same applies when numerical values ​​or mathematical formulas are used in the description of the embodiments described above.

Claims

1. A medical fluid delivery system comprising a catheter, a tube connected to the catheter, and a medical bag connected to the tube, for delivering a sample, which is a liquid generated in a living body, through the catheter and the tube to the medical bag, wherein the tube has an inlet end connected to the catheter into which the sample is introduced, an outlet end connected to the medical bag into which the sample is delivered, and an intermediate section provided between the inlet end and the outlet end, and the medical fluid delivery system comprises a closure section capable of blocking the flow of the sample through the tube by closing the intermediate section of the tube, a first state monitoring section that monitors the state of the tube or the inside of the tube at a first position upstream of the closure section in the intermediate section, and a second state monitoring section that monitors the state of the tube or the inside of the tube at a second position downstream of the closure section in the intermediate section. A medical fluid delivery system comprising: a control unit that releases the blockage state of the tube by the occlusion unit based on a comparison value obtained by comparing the value of a first state parameter at the first position with the value of a second state parameter at the second position.

2. A medical fluid delivery system according to claim 1, comprising a control device including the control unit, wherein the control device calculates the difference which is the comparison value, or the rate of change of the difference.

3. A medical fluid delivery system according to claim 1 or 2, wherein each of the first state monitoring unit and the second state monitoring unit is equipped with a pressure detection unit for detecting the pressure inside the tube.

4. A medical fluid delivery system according to claim 1 or 2, wherein each of the first state monitoring unit and the second state monitoring unit is equipped with a deformation detection unit for detecting the amount of deformation of the tube wall.

5. A medical fluid delivery system according to claim 1 or 2, wherein each of the first state monitoring unit and the second state monitoring unit detects a change in the liquid level of the sample to be collected in the tube.

6. A medical fluid delivery system according to claim 1 or 2, comprising a pump device connected to the tube and delivering the sample to be collected through the tube to the medical bag, wherein the occlusion portion is provided on the pump device.

7. A medical fluid delivery system according to claim 6, comprising a console equipped with the first state monitoring unit, the second state monitoring unit, and the pump device, wherein the console is positioned vertically above the medical bag.

8. A medical fluid delivery system according to claim 7, wherein the console is positioned adjacent to the medical bag and has an opening that communicates with the tube and is open to the atmosphere, and in the environment in which the medical fluid delivery system is used, the opening and the console are positioned at the same height in the direction of gravity.

9. A medical fluid delivery system according to claim 2, wherein the intermediate portion of the tube is equipped with a flow rate measuring unit capable of measuring the flow rate of the substance to be collected.

10. A medical fluid delivery system according to claim 9, wherein the flow rate measuring unit is capable of measuring the flow rate of urine, which is the object to be collected, and the catheter is placed in the bladder of the living body.

11. A medical fluid delivery system according to claim 10, wherein the control device displays on a display unit a first urine volume which is the flow rate per unit time based on the flow rate of the urine, and a second urine volume which is calculated based on the body weight of the living organism.

12. A medical fluid delivery system according to claim 4, wherein the intermediate portion of the tube has a detection portion in which the amount of deformation of the tube wall is detected by the deformation amount detection unit, and the hardness of the detection portion is lower than the hardness of the inlet end and the outlet end.

13. A medical fluid delivery system according to claim 1 or 2, wherein the tube comprises a first connector connectable to the first state monitoring unit and a second connector connectable to the second state monitoring unit.

14. A medical fluid delivery system according to claim 2, wherein the control device comprises a calculation unit that estimates the intravesical pressure of the living body based on the difference between the first state parameter and the second state parameter.

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