Measurement system

Abstract

Provided is a measurement system capable of continuously detecting the state of a body fluid in real time. The present invention pertains to a measurement system 10 that includes a catheter 12 having a lumen 21 for collecting a body fluid, the measurement system 10 comprising: a main flow path 50 that communicates with the lumen 21; a readily deformable part 56 that communicates with the main flow path 50 and has an internal space that is expandable / contractible as a result of pressure inside the main flow path 50; and a detection part 62 that detects changes in the shape of the readily deformable part 56.

Description

Measurement System

[0001] The present invention relates to a measurement system for measuring the state of bodily fluid in a lumen for collecting bodily fluid such as urine.

[0002] For the purpose of preventing kidney injury in advance and grasping the kidney condition in real time, a measurement system that measures urinary oxygen partial pressure, intravesical temperature, and urine volume is used. The measurement system includes: a catheter inserted into the bladder and equipped with a sensor for measuring intravesical temperature, urinary oxygen partial pressure and the like; a control device connected to the catheter for analyzing information from the sensor; and a urine storage part for storing urine collected by the catheter. Examples of such a measurement system include those disclosed in Patent Document 1.

[0003] International Publication No. 2017 / 213237 Specification

[0004] In the measurement system, urine flows from a catheter inserted into a patient to a urine storage bag of the urine storage part and is stored therein. The urine volume is recorded by visually reading scales provided on the urine storage bag. The urine storage bag and the catheter are connected by a drain tube. The drain tube has a larger diameter than the catheter and is configured to have a sufficient length. Therefore, the drain tube is arranged in a meandering manner from the patient to the urine storage bag, and urine滞留 in the drain tube may prevent urine from flowing smoothly from the catheter side to the urine storage bag. In order to prevent the urine volume from being unable to be measured accurately due to this situation, medical staff need to guide the urine in the drain tube to the urine storage bag by actions such as lifting and lowering the drain tube, which results in additional work.

[0005] For this reason, it is conceivable to provide a pump that feeds urine toward the urine storage bag to eliminate urine retention in the drain tube. However, if the pump is activated when there is no urine in the bladder, the tip of the drain tube will adhere to the inner wall of the bladder or the like, resulting in direct suction of the bladder, which poses a risk of damaging the bladder. Therefore, it is necessary to activate the pump only when urine is present in the bladder. This requires continuous and real-time detection of the status of urine production, and no such device has existed.

[0006] The present invention was made to solve the above-mentioned problems, and aims to provide a measurement system that can continuously and in real time detect the state of bodily fluids and collect those fluids.

[0007] A measurement system according to the present invention that achieves the above objective is a measurement system including a catheter having a lumen for collecting bodily fluids, comprising: a main channel communicating with the lumen; a deformable portion communicating with the main channel and having an internal space that can expand and contract by the pressure in the main channel; and a detection unit for detecting changes in the shape of the deformable portion.

[0008] The measurement system (1) configured as described above allows for the continuous and real-time detection of the state of bodily fluids by measuring the change in shape of the internal space of the easily deformable section, which is in communication with the main flow path through which bodily fluids flow, due to the pressure of the main flow path, and by measuring this change with the detection unit.

[0009] (2) The measurement system described in (1) above is further provided with a connector section having the main channel, the easily deformable section, and the detection section, wherein the connector section may have a catheter connection section that connects to the proximal end of the catheter. This allows the measurement system to easily communicate the internal space of the main channel and the easily deformable section with the lumen of the catheter by connecting the connector section to the catheter.

[0010] (3) In the measurement system described in (2) above, the connector portion may have a rigid detection chamber that accommodates the easily deformable portion, and the detection unit may be attached to the detection chamber. This allows the measurement system to reliably detect volume changes due to expansion and contraction of the easily deformable portion using the detection unit installed in the rigid detection chamber.

[0011] (4) In the measurement system described in (3) above, the detection unit may be configured to detect changes in pressure within the detection chamber due to changes in the volume of the substance within the detection chamber. This allows the measurement system to detect changes in shape due to expansion and contraction of the easily deformable part by pressure detection.

[0012] (5) In the measurement system of (3) or (4) above, the connector portion is such that the first member and the second member are separable along the direction of the flow of the body fluid, the first member comprises the catheter connection portion, the first main flow path component which constitutes the upstream side of the main flow path in the direction of the flow of the body fluid, and the easily deformable portion which communicates with the first main flow path component, and the second member may comprise the second main flow path component which constitutes the downstream side of the main flow path in the direction of the flow of the body fluid, and the detection chamber component which constitutes at least a part of the detection chamber. As a result, by connecting the easily deformable portion to the first member, the measurement system can connect the first member to a catheter and insert the catheter into the body, and the status of body fluid collection can be confirmed by the expansion of the easily deformable portion, thereby allowing the body fluid collection step to proceed smoothly.

[0013] (6) In any of the measurement systems described in (1) to (5) above, the detection unit may be configured to detect the change in the relative position between the detection unit and the easily deformable part due to a change in the volume of the internal space of the easily deformable part. This allows the measurement system to reliably detect changes in the shape of the easily deformable part by detecting the change in the volume of the easily deformable part.

[0014] (7) In any of the measurement systems described in (1) to (6) above, the main flow path may be formed along a straight axial direction and may include a body fluid flow path that branches off from the main flow path in a direction different from the axial direction. This allows the body fluid flow path to be curved, making it possible to insert a measuring part, such as an optical fiber to be inserted into a catheter, in a straight line relative to the main flow path, thus facilitating the insertion of the measuring part.

[0015] (8) In any of the measurement systems described in (1) to (7) above, the catheter may be fitted with at least one movable sensor. This allows the measurement system to have the catheter and the sensor coexist.

[0016] (9) In any of the measurement systems described in (1) to (8) above, a control device may be provided that drives and controls a pump that sucks the bodily fluid from the lumen in accordance with the change in shape of the easily deformable part detected by the detection unit. This allows the measurement system to drive the pump in accordance with the flow state of the bodily fluid.

[0017] This is an explanatory diagram showing the overall measurement system of this embodiment. This is a configuration diagram of the measurement system. This is a cross-sectional view showing the structure of the tip of the catheter. This is a front view of the connector. This is a cross-sectional view of the connector when the intrabladder pressure is low. This is a cross-sectional view of the connector when the intrabladder pressure is high. This is a plan view of the expandable body. This is a cross-sectional view of the expandable body, where (a) shows the contracted state of the expandable body and (b) shows the expanded state of the expandable body. This is a diagram showing the measurement flow of the measurement system. This is a cross-sectional view of the state in which the tip component of the connector is connected to the catheter, where (a) shows the state in which the catheter is being inserted into the body and (b) shows the state in which the catheter has been inserted into the bladder. This is a cross-sectional view of the connector, where the base component is attached to the tip component, and the lid member, sensor cover, and optical fiber are shown in a disassembled state. This is a cross-sectional view of the expandable body according to a modified example.

[0018] Embodiments of the present invention will be described below with reference to the drawings. Note that the size and proportions of the components shown in the drawings may be exaggerated for illustrative purposes and may differ from their actual size and proportions.

[0019] The measurement system 10 according to this embodiment can continuously measure the condition inside the patient's bladder, collect urine from the bladder, and measure the urine volume.

[0020] As shown in Figure 1, the measurement system 10 includes a catheter 12 inserted into the patient's bladder, a console 16 to which the proximal end of the catheter 12 is connected, and a urine collection unit 18 for storing the patient's urine collected by the catheter 12. The measurement system 10 is also configured to detect whether or not urine is flowing from the catheter 12 to the urine collection unit 18 by detecting a change in bladder pressure or the amount of urine stored in the bladder. For this purpose, the measurement system 10 includes a detection unit 62 provided in the connector unit 40 connecting the catheter 12 and the console 16, and a control device 60 inside the console 16. The urine collection unit 18 is composed of a urine collection bag 80.

[0021] The catheter 12 is equipped with an internal urine sensor 23 for measuring the state of urine in the bladder. The urine sensor 23 includes an oxygen measuring device 30 (described later) for measuring the partial pressure of oxygen in the urine in the bladder.

[0022] The catheter 12 has a long shaft 20 that extends axially and has a lumen 21 for collecting body fluid, specifically urine. The tip of the shaft 20 is provided with a balloon 22 that can be expanded in the bladder. The proximal end of the shaft 20 is connected to a hub 29, which is connected to a catheter connection portion 46 of a connector portion 40.

[0023] The shaft 20 has appropriate flexibility and rigidity so that it can be inserted into the bladder through the urethra. For this reason, the shaft 20 can be made of materials such as silicone or latex rubber, elastomer, polyvinyl chloride, polyurethane, or plastic tubing.

[0024] The hub 29 of the catheter 12 has a branching section 27. A connecting cable 90 extends from the branching section 27, to which wiring from a urine sensor 23 located inside the catheter 12 is connected. The connecting cable 90 is connected to the console 16.

[0025] The connector section 40 is used to connect the catheter 12 and the console 16. The tip of the connector section 40, the catheter connection section 46, is connected to the hub 29 of the catheter 12, and the urinary drainage tube 91 is connected to the connector branch section 47. The urinary drainage tube 91 is connected to the urine collection bag 80 of the urine collection section 18 via the console 16. Inside the console 16, there is a pump 70 that pumps the urine in the urinary drainage tube 91 towards the urine collection section 18.

[0026] The connector section 40 has an optical fiber 32 extending from its base end, which functions as a measuring unit inserted into the catheter 12. The optical fiber 32 constitutes the oxygen measuring device 30 and is connected to the console 16. The optical fiber 32 is movably positioned relative to the catheter 12. A connecting wire 62a, which is wiring from a detection unit 62 located inside, also extends from the connector section 40. The connecting wire 62a is connected to the console 16. The console 16 has a urine data acquisition unit 61 that acquires data measured by the urine sensor 23. As the measuring unit, in addition to a fluorescent oxygen sensor capable of measuring the partial pressure of oxygen by analyzing the fluorescence characteristics emitted from a fluorescent dye that reacts with oxygen and is located at the tip of the optical fiber 32, various known enzyme electrode sensors can be used.

[0027] A control device 60 is provided within the console 16. As shown in Figure 2, the control device 60 comprises an analysis unit 64 and a storage unit 65, which analyze information from each sensor of the measurement system 10, display and notify information, and control the pump 70. The analysis unit 64 and the storage unit 65 can be composed of, for example, a CPU and memory. The control device 60 may also be located externally by coordinating with an external device via wireless communication or the like.

[0028] The analysis unit 64 is connected to the aforementioned urine data acquisition unit 61 and can cause the urine data acquisition unit 61 to acquire urine data measured by the urine sensor 23 provided on the catheter 12. The analysis unit 64 is connected to the aforementioned detection unit 62 and can cause the detection unit 62 to acquire pressure changes due to changes in the shape of the expander 56. The analysis unit 64 is connected to the pump control unit 63 and can control the on / off state of the pump based on the data acquired by the detection unit 62.

[0029] The analysis unit 64 is connected to the display unit 66 and can display urine-related data on the display unit 66. The analysis unit 64 is connected to the notification unit 67 and can provide notifications such as alarms. The analysis unit 64 is connected to the communication unit 68 and can communicate with the outside world.

[0030] The structure of the tip of the catheter 12 will now be described. As shown in Figure 3, the shaft 20 has a lumen 21 inside, and the tip has a urinary inlet 24 for allowing urine from the bladder to flow into the lumen 21. A tip member 25 is provided at the tip of the shaft 20, which closes the tip of the lumen 21.

[0031] An oxygen sensor 31 is positioned within the lumen 21 so as to be in contact with the urine flowing within the lumen 21. An optical fiber 32 inserted into the lumen 21 is fixed so that its tip is close to the oxygen sensor 31. The oxygen sensor 31 is a fluorescent sensor and has a phosphor on its surface. The phosphor emits fluorescence when excited by light irradiated from the optical fiber 32, and this fluorescence is received by the optical fiber 32. The oxygen measuring device 30 can detect the oxygen concentration (partial pressure) in the urine by detecting the fluorescence received by the optical fiber 32.

[0032] A temperature sensor 34 is positioned within the lumen 21 to detect the temperature of the urine in the bladder. The temperature sensor 34 is electrically connected to the connecting cable 90 by a transmission line 34a. The temperature sensor 34 is usually installed in a separate lumen, encased in a temperature-permeable electrical insulator, and is not in contact with the liquid. This may be in separate lumens if the lumen 21 is divided, or the temperature sensor 34 may be located within the lumen 21. In that case, it is preferable that it has an insulating or isolation structure to ensure electrical safety.

[0033] The balloon 22, located at the tip of the shaft 20, can be expanded and contracted radially by an expansion fluid. The expansion fluid can be injected through an expansion port 26 (Figure 1) located in the hub 29. The hub 29 is equipped with a one-way valve, which allows the balloon to maintain its expanded state.

[0034] Next, the connector section 40 will be described in detail. As shown in Figure 4, the connector section 40 has a housing 41 which includes a catheter connection section 46 having a tip with multiple tapered diameters for connecting the hub 29 of the catheter 12, a flow path branch section 47 having a body fluid flow path 54 inside, a fiber insertion section 48 at the base end for inserting the optical fiber 32, and an expander housing section 49 for housing the expander 56. The housing 41 is provided with an expander housing section 49 for housing the expander 56, and a connecting wire 62a is drawn out from it.

[0035] As shown in Figure 5, the housing 41 of the connector portion 40 has a main channel 50 extending from the tip to the base end. The main channel 50 is formed along a linear axis X direction. A fiber insertion portion 48, which is the measurement portion insertion portion, is located at the base end of the main channel 50, and a valve body 48a is provided on the base end face of the main channel 50. The optical fiber 32 can be inserted through the valve body 48a while ensuring the liquid-tightness of the main channel 50.

[0036] A detection chamber 52 is formed inside the expandable body housing section 49 of the connector section 40. An expandable body 56, which is an easily deformable part with an internal space, is placed in the detection chamber 52. Since the connector section 40 is made of a rigid material, the detection chamber 52 is rigid and does not deform. On the other hand, the expandable body 56 placed in the detection chamber 52 can be easily deformed by changes in internal pressure. The internal space of the expandable body 56 is in communication with an expandable body tube 57. The expandable body tube 57 is connected to the main flow path 50. Therefore, urine flowing in the main flow path 50 is introduced into the expandable body 56, and it can expand and contract in accordance with changes in the amount of urine. The amount of urine introduced into the expandable body 56 increases when the bladder pressure is high and the pressure in the main flow path 50 is high, and decreases when the bladder pressure is low and the pressure in the main flow path 50 is low. Therefore, by detecting the internal pressure of the expandable body 56 through the state of expansion and contraction of the expandable body 56, it is possible to determine whether the bladder pressure is high or low.

[0037] Inside the flow path branching section 47 of the connector section 40, a fluid flow path 54 is provided that branches off in a direction different from the axis X direction of the main flow path 50. The fluid flow path 54 communicates with the urinary catheter 91 connected to the flow path branching section 47. Since the collected urine flows into the fluid flow path 54 that branches off from the main flow path 50, the direction from the valve body 48a into which the optical fiber 32 is inserted towards the main flow path 50 can be made straight. This makes it easier to insert the optical fiber 32 into the connector section 40.

[0038] The housing 41 of the connector portion 40 is constructed by combining multiple components. The tip portion of the housing 41 is made up of a first component, the tip component 42. The base portion of the housing 41 is made up of a second component, the base component 43. The tip component 42 has a first main flow path component 42a that constitutes the upstream side of the main flow path 50 in the direction of urine flow, and the base component 43 has a second main flow path component 43a that constitutes the downstream side of the main flow path 50 in the direction of urine flow. By connecting the tip component 42 and the base component 43, the main flow path 50 is formed by the first main flow path component 42a and the second main flow path component 43a.

[0039] The expansion tube 57 is connected to the first main flow channel component 42a of the tip component 42. The expansion tube 57 is sealed on its outer circumference and extends to the outside of the tip component 42 to ensure liquid-tightness of the first main flow channel component 42a. The expansion tube 57 may be provided integrally with the housing 41 of the connector component 40.

[0040] The base component 43 has a detection chamber component 43b that forms the lower part of the detection chamber 52. A cover member 44 that forms the upper part of the detection chamber 52 is attached to the detection chamber component 43b. A sensor cover 45 that holds the detection unit 62 exposed toward the detection chamber 52 is attached to the cover member 44. A connecting wire 62a extending from the detection unit 62 is drawn out from the sensor cover 45.

[0041] The detection unit 62 is, for example, an infrared sensor that measures the distance to the surface of the expandable body 56 (i.e., the relative position between the detection unit 62 and the surface of the expandable body 56). The distance between the detection unit 62 and the surface of the expandable body 56 changes as the height of the expandable body 56 changes due to shape changes such as expansion and contraction caused by changes in internal pressure. Therefore, by measuring the distance to the surface of the expandable body 56, the detection unit 62 can detect the volume change as a physical change of the expandable body 56, and thereby detect the pressure change as a physical change of the internal space of the expandable body 56. Note that the detection unit 62 is not limited to an infrared sensor, and may be, for example, an ultrasonic sensor that measures the distance to the surface of the expandable body 56 using ultrasound. The detection unit 62 may also be a contact sensor that detects contact with the surface of the expandable body 56. The detection unit 62 may also be a pressure sensor that contacts the surface of the expandable body 56 and measures the pressure applied by the expandable body 56. Furthermore, the detection unit 62 may be a pressure sensor that measures the air pressure inside the detection chamber 52 as the expansion and contraction of the expandable body 56 occurs, that is, the pressure change inside the detection chamber 52 as the volume change of the substance inside the detection chamber 52 occurs.

[0042] FIG. 5 shows a state where intravesical pressure is low or the volume of urine in the bladder is small. At this time, the pressure in the internal space of the main flow path 50 and the expansion body 56 communicating therewith is low, and the expansion body 56 is in a small volume state (low expansion state). When urine is produced in the bladder and intravesical pressure rises, the pressure in the internal space of the main flow path 50 and the expansion body 56 communicating therewith rises. Along with this, as shown in FIG. 6, the volume of the expansion body 56 increases (high expansion state). The detection unit 62 detects a pressure change caused by a volume change of the internal space of the expansion body 56. The analysis unit 64 of the control device 60 can determine the level of intravesical pressure based on whether the pressure of the expansion body 56 detected by the detection unit 62 is equal to or higher than a predetermined threshold or less than the threshold.

[0043] As shown in FIGS. 7 and 8(a), the expansion body 56 is constituted by a thin membrane portion 56a. A peripheral portion of the expansion body 56 is provided with a fused portion 56b formed by fusing flat planar membrane portions 56a to each other over the entire circumference, and an internal space is formed. Therefore, the expansion body 56 has a flat shape in a contracted state. A distal end portion of the expansion body tube 57 is disposed inside the expansion body 56, and in this state, the fused portion 56b is formed and integrated.

[0044] As shown in FIG. 8(b), when fluid flows in from the expansion body tube 57 and the pressure of the internal space increases, the expansion body 56 can expand so that the height thereof increases.

[0045] Next, the operation flow of the measurement system 10 will be described. In the initial state, the catheter 12, the connector part 40, and the optical fiber 32 are not connected, and the optical fiber 32, the connecting cable 90, and the connecting wire 62a are not connected to the console 16. Furthermore, in the initial state, the connector part 40 is separated into a tip component 42 and a base component 43. As shown in Figure 9, first, the catheter 12 and the tip component 42 of the connector part 40 are connected (S1). As shown in Figure 10(a), the tip component 42 is connected to the expander 56 by an expander tube 57. Before the catheter 12 is inserted into the bladder, there is no inflow of urine into the first main channel component 42a, so the expander 56 is in a contracted state. To prevent the outflow of urine flowing into the first main channel component 42a, a sealing material 58 is provided at the base end of the tip component 42 to block the first main channel component 42a. The sealing material 58 is detachably provided from the tip component 42. The sealing material 58 is not limited to being detachably attached to the tip component 42, but may be, for example, a thin film-like member that penetrates when the base component 43 is attached to the tip component 42. Alternatively, the tip component 42 may have a valve body that opens when the base component 43 is attached, instead of the sealing material 58.

[0046] After connecting the catheter 12 to the catheter connection part 46 of the tip component 42, the shaft 20 of the catheter 12 is inserted into the bladder (S2). As the shaft 20 enters the bladder, as shown in Figure 10(b), urine is collected from the bladder at the tip of the shaft 20 and flows into the first main channel component 42a, causing the expander 56 to expand. Since the expander 56 is exposed to the outside of the tip component 42, the operator can easily visually confirm the expansion of the expander 56. This allows the operator to confirm that the shaft 20 has entered the bladder normally (S3).

[0047] Next, the connector portion 40 is assembled (S4). As shown in FIG. 11, the proximal end constituent portion 43 is locked and fixed to the proximal end portion of the distal end constituent portion 42. In order to secure liquid-tightness of the main flow path 50 formed by the first main flow path constituent portion 42a and the second main flow path constituent portion 43a, a space between the proximal end constituent portion 43 and the distal end constituent portion 42 is sealed. After the distal end constituent portion 42 and the proximal end constituent portion 43 are integrated, a urinary catheter tube 91 extending from the console 16 is connected to the flow path branching portion 47 of the connector portion 40.

[0048] The expansion body 56 is disposed in the detection chamber constituent portion 43b of the proximal end constituent portion 43. Since the detection chamber constituent portion 43b is open at the upper side, the expansion body 56 can be easily disposed. After the expansion body 56 is disposed in the detection chamber constituent portion 43b, a lid member 44 to which the detection portion 62 and the sensor covering portion 45 are attached is attached to the detection chamber constituent portion 43b.

[0049] Next, the optical fiber 32 constituting the urine sensor 23 is inserted into the catheter 12 (S5). The optical fiber 32 has a proximal end connected to the console 16, a distal end inserted through the valve body 48a from the fiber insertion portion 48 corresponding to the proximal end of the connector portion 40, and inserted from the connector portion 40 into the lumen 21 of the shaft 20. The optical fiber 32 is inserted until the distal end reaches a predetermined position of the distal end portion of the shaft 20. At this time, the connection cable 90 and the connection line 62a are respectively connected to the console 16. Up to this point, each part constituting the measurement system 10 has been connected respectively.

[0050] Next, an operator performs a start operation on the console 16 (S6). By the start operation, data in the bladder is measured by the urine sensor 23, and the analysis unit 64 acquires the data measured by the urine data acquisition unit 61, analyzes the data, and displays the result on the display unit 66 or issues a notification via the notification unit 67. In addition, the communication unit 68 communicates with the outside as necessary.

[0051] The analysis unit 64 monitors the pressure change of the expansion body 56 in the detection unit 62 (S7). If the expansion body 56 has not expanded beyond a certain level, that is, the pressure in the internal space of the expansion body 56 has not reached or exceeded a certain level, and a termination operation has not been performed (S8), the step of S7 is repeated. If the operator has performed the termination operation in S8, the measurement system 10 terminates its operation.

[0052] When urine is produced in the bladder, it is collected by the catheter 12 and flows through the main flow path 50 of the lumen 21 and connector section 40 and the urinary drainage tube 91 toward the urine collection bag 80. If, in S7, the expander 56 has expanded beyond a certain point, that is, the pressure in the internal space of the expander 56 is above a certain point, the analysis unit 64 determines that the bladder pressure has increased and instructs the pump control unit 63 to turn on the pump 70 (S9). With the pump 70 turned on, the urine can flow smoothly toward the urine collection bag 80.

[0053] The analysis unit 64 continues to monitor the change in internal pressure of the expander 56 in the detection unit 62 (S10). If it is detected in S10 that the expander 56 has expanded beyond a certain level, and no termination operation has been performed (S11), the pump 70 remains on and step S10 is repeated. If the operator has performed a termination operation in S11, the measurement system 10 terminates its operation.

[0054] If it is detected in S10 that the expander 56 has not expanded beyond a certain point, the analysis unit 64 determines that the bladder pressure has decreased and instructs the pump control unit 63 to turn off the pump 70 (S12). The steps from S7 are then repeated.

[0055] In this way, by controlling the pump 70 to turn on or off in accordance with the expansion and contraction of the expandable body 56 whose internal space communicates with the main flow path 50, when urine is being produced in the bladder, the pump 70 facilitates the flow of urine to the urine collection bag 80, and when no urine is being produced in the bladder, the pump 70 is stopped to prevent the bladder from being aspirated when the bladder pressure is low. This reduces the effort required to support the flow of urine from the catheter 12 to the urine collection bag 80.

[0056] Modifications of the expandable body will now be described. As shown in Figure 12(a), the expandable body 100 has a cross-sectional shape in which two stages, a lower stage and an upper stage, are connected and integrated in the center. In this way, because the expandable body 100 has a two-stage shape, even if the volume of the internal space of the expandable body 100 is small, the amount of change in the height direction during pressure changes can be increased, so that the detection unit 62 can detect pressure changes with high accuracy. The expandable body 100 may have a shape with three or more stages. Also, as shown in Figure 12(b), the expandable body 101 may be formed by folding it back in the middle to create a two-stage shape. In this case as well, the amount of change in the height direction during pressure changes can be increased, so that the detection unit 62 can detect pressure changes with high accuracy. The expandable body 101 may be folded back two or more times to have a shape with three or more stages.

[0057] As described above, the (1) measurement system 10 according to this embodiment is a measurement system 10 including a catheter 12 having a lumen 21 for collecting bodily fluids, comprising a main flow path 50 communicating with the lumen 21, a deformable portion 56 communicating with the main flow path 50 and having an internal space that can expand and contract due to the pressure in the main flow path 50, and a detection unit 62 for detecting changes in the shape of the deformable portion 56. With the measurement system 10 configured in this way, the internal space of the deformable portion 56 communicating with the main flow path 50 through which bodily fluids flow changes shape due to the pressure in the main flow path 50, and by measuring this with the detection unit 62, the state of bodily fluids can be detected continuously and in real time.

[0058] (2) The measurement system 10 described in (1) above is further provided with a connector section 40 having a main flow path 50, a deformable section 56, and a detection section, and the connector section 40 may have a catheter connection section 46 that connects to the proximal end of the catheter 12. By connecting the connector section 40 to the catheter 12, the measurement system 10 can easily communicate the internal space of the main flow path 50 and the deformable section 56 with the lumen 21 of the catheter 12.

[0059] (3) In the measurement system 10 described in (2) above, the connector portion 40 has a rigid detection chamber 52 that houses the easily deformable portion 56, and the detection unit 62 may be attached to the detection chamber 52. This allows the measurement system 10 to reliably detect the volume change due to the expansion and contraction of the easily deformable portion 56 with the detection unit 62 installed in the rigid detection chamber 52.

[0060] (4) In the measurement system 10 described in (3) above, the detection unit 62 may be configured to detect changes in pressure within the detection chamber 52 due to changes in the volume of the substance within the detection chamber 52. This allows the measurement system 10 to detect changes in shape due to expansion and contraction of the easily deformable part 56 by pressure detection. For example, detection can be performed using a contact sensor, an optical sensor, an ultrasonic sensor, etc.

[0061] (5) In the measurement system 10 of (3) or (4) above, the connector portion 40 is such that a first member 42 and a second member 43 can be separated along the direction of body fluid flow, the first member 42 comprises a catheter connection portion 46, a first main flow path component 42a that constitutes the upstream side of the main flow path 50 in the direction of body fluid flow, and a deformable portion 56 that communicates with the first main flow path component 42a, the second member 43 comprises a second main flow path component 43a that constitutes the downstream side of the main flow path 50 in the direction of body fluid flow, and a detection chamber component 43b that constitutes at least a part of the detection chamber 52. As a result, when the measurement system 10 connects the first member 42 to the catheter 12 and inserts the catheter 12 into the body, the status of body fluid collection can be confirmed by the expansion of the deformable portion 56, and the body fluid collection step can be carried out smoothly.

[0062] (6) In any of the measurement systems 10 described in (1) to (5) above, the detection unit 62 may be configured to detect changes in the relative position (distance) between the detection unit 62 and the easily deformable part 56 due to changes in the volume of the internal space of the easily deformable part 56. This allows the measurement system 10 to reliably detect changes in the shape of the easily deformable part 56 by detecting changes in the volume of the easily deformable part 56. Changes in relative position (distance) can be detected, for example, by an infrared sensor.

[0063] (7) In any of the measurement systems 10 described in (1) to (6) above, the main flow path 50 may be formed along a straight axial direction and may include a body fluid flow path 54 that branches off from the main flow path 50 in a direction different from the axial direction. As a result, the body fluid flow path of the measurement system 10 is curved, so that the measuring part, such as the optical fiber 32 to be inserted into the catheter 12, can be inserted linearly with respect to the main flow path 50, making it easier to insert the measuring part.

[0064] (8) In any of the measurement systems 10 described in (1) to (7) above, the catheter 12 may be fitted with at least one movable sensor. This allows the measurement system 10 to have the catheter 12 and the sensor coexist.

[0065] (9) In any of the measurement systems 10 described in (1) to (8) above, a control device 60 may be provided that drives and controls a pump 70 that sucks bodily fluids from the lumen 21 in accordance with the change in shape of the easily deformable part 56 detected by the detection unit 62. This allows the measurement system 10 to drive the pump 70 in accordance with the flow state of the bodily fluids.

[0066] It should be noted that the present invention is not limited to the embodiments described above, and various modifications can be made by those skilled in the art within the technical framework of the present invention.

[0067] This application is based on Japanese Patent Application No. 2025-45855, filed on March 19, 2025, and its disclosures are referenced and incorporated as a whole.

[0068] 10 Measurement system 12 Catheter 16 Console 18 Urine collection section 20 Shaft 21 Lumen 22 Balloon 23 Urine sensor 24 Urinary drainage port 32 Optical fiber 40 Connector section 41 Housing 42 Tip component (first member) 42a First main flow path component 43 Base component (second member) 43a Second main flow path component 43b Detection chamber component 44 Lid member 45 Sensor cover 46 Catheter connection section 47 Flow path branch section 48 Fiber insertion section 48a Valve body 49 Expanded body housing section 50 Main flow path 52 Detection chamber 54 Body fluid flow path 56 Expanded body (easily deformable section) 57 Expanded body tube 60 Control device 61 Urine data acquisition unit 62 Detection unit 62 Pump control unit 63 Analysis unit 64 Storage unit 65 Display unit 66 Notification unit 67 Communication unit 70 Pump 80 Urine collection bag 91 Urinary catheter

Claims

1. A measuring system comprising a catheter having a lumen for collecting bodily fluids, the system comprising: a main channel communicating with the lumen; a deformable portion communicating with the main channel and having an internal space that can expand and contract by the pressure in the main channel; and a detection unit for detecting changes in the shape of the deformable portion.

2. The measurement system according to claim 1, comprising a connector section having the main flow path, the easily deformable section, and the detection section, wherein the connector section has a catheter connection section that connects to the proximal end of the catheter.

3. The measurement system according to claim 2, wherein the connector portion has a rigid detection chamber that accommodates the easily deformable portion, and the detection portion is attached to the detection chamber.

4. The measurement system according to claim 3, wherein the detection unit detects a change in pressure inside the detection chamber due to a change in the volume of a substance inside the detection chamber.

5. The measurement system according to claim 3, wherein the connector portion comprises a first member and a second member that are separable along the direction of the flow of the bodily fluid, the first member comprises a catheter connection portion, a first main flow path component that constitutes the upstream side of the main flow path in the direction of the flow of the bodily fluid, and a deformable portion that communicates with the first main flow path component, and the second member comprises a second main flow path component that constitutes the downstream side of the main flow path in the direction of the flow of the bodily fluid, and a detection chamber component that constitutes at least a part of the detection chamber.

6. The measurement system according to claim 1, wherein the detection unit detects a change in the relative position between the detection unit and the easily deformable part due to a change in the volume of the internal space of the easily deformable part.

7. The measurement system according to any one of claims 1 to 6, wherein the main flow path is formed along a straight axial direction, and the system further comprises a fluid flow path branching from the main flow path in a direction different from the axial direction.

8. The measurement system according to any one of claims 1 to 6, wherein the catheter is equipped with at least one movable sensor.

9. The measurement system according to any one of claims 1 to 6, further comprising a control device that drives and controls a pump for aspirating bodily fluids from the lumen in accordance with the change in shape of the easily deformable part detected by the detection unit.

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