Urine collection monitoring system and method

Abstract

The present invention relates to a urine collection monitoring system and method, the system comprising: a collection module for collecting urine discharged by a patient, the collection module being equipped with an external bladder capable of collecting pre-stored patient urine to control the urine circulation status; a monitoring module for online monitoring of the patient urine obtained by the collection module; and an analysis module for controlling the pumping structure of the contrast fluid and / or the injection status of the body fluid management unit based on the patient urine monitoring results. The present application can continuously or intermittently monitor acute renal failure markers in the patient's urine to assess the degree and trend of acute renal failure during surgery, effectively identify and reduce the risk of renal failure during surgery, and significantly reduce the probability of acute renal failure occurring during surgery. Effective detection of the concentration of acute kidney injury markers and other parameters in urine can also provide support for the patient's water chemotherapy to ensure the surgical status and alleviate the risk of renal failure.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to body fluid collection monitoring, and specifically to a urine collection monitoring system and method. Background Art

[0002] During radiofrequency ablation for atrial fibrillation, local anesthesia is used and a large amount of fluid is administered intraoperatively. To prevent renal or heart failure, patients, particularly elderly individuals prone to urinary tract infections, are encouraged to urinate on the operating table. Furthermore, during complex coronary interventions, which are long procedures and require large amounts of contrast agents, patients are encouraged to urinate spontaneously on the operating table. However, commonly used contrast agents are hyperosmolar and are filtered unchanged by the glomeruli without being absorbed by the renal tubules. Dehydration increases the concentration of these agents in the kidneys, potentially causing kidney damage and acute renal failure. To prevent renal or heart failure, continuous monitoring of specific urine parameters is necessary, such as urine volume per unit time and physiological indicators associated with renal or heart failure, such as turbidity, dark color, and absolute serum creatinine levels.

[0003] In the prior art, the more sensitive acute kidney injury (AKI) markers among the specific indicators in urine include neutrophil gelatinase associated lipocalin (NGAL). Under normal circumstances, the concentration of NGAL in urine ranges from 0.7 to 9.6 ng / mL, and the concentration of NGAL in plasma ranges from 3 to 106 ng / mL. When acute kidney injury occurs, the NGAL concentration will rise sharply in a short period of time. For example, the increase achieved within 2 hours will be tens to hundreds of times higher than the critical value. Therefore, there are already a variety of NGAL concentration detection schemes in the prior art, including test kits, online real-time detection devices, and portable detection devices.

[0004] Among the existing technical solutions for urine collection and body fluid management during surgery, for example, the patent with announcement number CN208892944U discloses a urine collector for patients with urinary incontinence, including a protective layer with two symmetrically arranged foldable halves, a urine absorbent layer is provided on the side of the protective layer that contacts the human skin, and an isolation belt is provided around the urine absorbent layer to surround the urine absorbent layer to limit the sliding of the urine absorbent layer, an adhesive belt is provided on the side wall of the isolation belt close to the urine absorbent layer, the adhesive belt is pressed on the edge of the urine absorbent layer, and the adhesive belt and the urine absorbent layer are connected as a whole by male and female adhesive buckles; the technical solution of this patent relies on the liquid absorption capacity of the urine absorbent layer to collect urine, but the absorption capacity of the urine absorbent layer has an upper limit, and the skin feel is not good, so it is not suitable for situations where the urine volume is large or the urine needs to be analyzed and processed.

[0005] Patent publication number CN203763446U discloses an inflatable interventional surgical urinary catheter pad, designed to assist patients in urinating during interventional procedures without contaminating the sterile surgical field. The device comprises an inflatable urine collector, a urine drainage tube, and an inflation / deflation mechanism. The urine collector comprises a flat air cushion at the bottom, with a urine drainage tube installed in a low-lying area, which connects to a urine bag via a tee. The inflation / deflation mechanism is connected to the outer wall of the surrounding air cushion and connected to a manually squeezed, one-way inflatable ball via a tee. Adjusting the tee allows for switching between inflation and deflation. This patent combines an operating table with a urinary catheter structure to achieve non-invasive urine collection.

[0006] In the above two prior art technical solutions for perioperative urine collection and monitoring, the existing urine collection and monitoring devices are not suitable for automatic monitoring of physiological indicators related to renal failure or heart failure, and the urine needs to be transferred to the laboratory for processing, which is not conducive to automatic and convenient detection of urine in perioperative patients; in addition, the open transfer process of urine is not conducive to maintaining the environment of the ward or operating room; and the urine monitoring results are not correlated with the patient's physiological parameters to assist in the management of body fluids during the operation, that is, a system and method for managing body fluids during the operation based on urine monitoring parameters, injection parameters, and patient physiological parameters is not provided.

[0007] The patent with announcement number CN107660136B discloses a system for monitoring renal function, a urine detection device and a method for monitoring renal function. The renal function monitoring system provides a portable urine monitoring system that can provide real-time and continuous feedback on urine output and / or the level of at least one urine component. The renal function monitoring system also includes at least one urine detection device, wherein the urine detection device includes a digital weight scale, a bracket on which a urine collection container can be located, and an interface between the digital weight scale and the bracket, which transfers the force of the bracket and the contents of the urine collection container to the digital weight scale. In addition, the portable monitoring device includes an adaptive and modular self-learning algorithm for real-time assessment of the risk of acute kidney injury (AKI).

[0008] The technical solution of this patent is based on the collection of urine from patients through a urethral catheter, which can provide continuous monitoring feedback of urine output and urine composition, and rely on the monitoring results of volume flow rate parameters of urine volume over time to evaluate kidney function. However, on the one hand, it is limited to patients with a foley catheter. It uses a complex weight measurement mechanism to achieve "second-to-second monitoring" of urine weight, then determines the initial density, and then obtains the urine volume flow rate based on the conversion of initial density to volume; on the other hand, it relies on an ion sensor to measure urine sodium. This existing technology has only made contributions to the existing technology in terms of weight measurement, but its accuracy in calculating urine volume flow rate based on initial density is very questionable. This is because the catheter itself will also adhere to urine protein in the urine. Therefore, not only does the density of the urine itself fluctuate, but the gravity fluctuation caused by dripping will also cause "second-to-second" weight fluctuations. This fluctuation will constitute a non-negligible interference when the urine volume is small. Therefore, the path provided by this patent cannot be reliably used clinically, especially in situations where many patients cannot have a urinary catheter inserted; and the urine sodium concentration is not sensitive enough to contrast agent-induced renal failure, and the risk of renal failure cannot be detected in a timely manner.

[0009] Moreover, in the technical solution for urine collection and monitoring during surgery, the existing urine collection and monitoring device is not suitable for automatic and continuous monitoring of urine. The urine needs to be transferred to a laboratory for processing, which is not conducive to automatic and convenient detection of urine in surgical patients. The open urine transfer process is also not conducive to maintaining the environment of the ward or operating room. Moreover, the urine monitoring results are not correlated with the patient's physiological parameters to assist in the management of body fluids during surgery. That is, a system and method for body fluid management during surgery based on urine monitoring parameters, injection parameters, and patient physiological parameters is not provided.

[0010] In addition, on the one hand, there are differences in understanding among those skilled in the art; on the other hand, the inventor studied a large number of documents and patents when making the present invention, but due to space limitations, not all details and contents are listed in detail. However, this does not mean that the present invention does not have the characteristics of these prior arts. On the contrary, the present invention already has all the characteristics of the prior art, and the applicant reserves the right to add relevant prior art to the background art. Summary of the Invention

[0011] In response to at least some of the shortcomings of the prior art, the present application also provides a urine collection and monitoring system, which includes: a collection module for collecting urine discharged by a patient, the collection module including a surgical pad configured with a bionic position, the surgical pad also configured with an extracorporeal bladder capable of collecting pre-stored patient urine, wherein the extracorporeal bladder can selectively provide urine to the downstream, and the provision of urine is implemented based on the patient's urination time and / or detection frequency as a gating instruction; a monitoring module for online monitoring of the patient's urine obtained by the collection module; an analysis module for controlling the patient's injected liquid parameters based on the patient's urine monitoring results; wherein the monitoring module is configured with a detection unit for monitoring urine components or markers in urine, and when the detection unit passes the urine monitoring kit through the test position for receiving the sampled urine and the camera position for image acquisition, the detection unit obtains the urine detection results based on the marker appearance of the urine monitoring kit and transmits them to the analysis module to control the injection status of the contrast fluid pumping structure and / or the body fluid management unit.

[0012] In view of the fact that there are few devices in the prior art that are suitable for patients in the surgical or perioperative period who are inconvenient to have a catheter inserted, the collection module proposed in this application is equipped with a surgical pad. The surgical pad can serve as a cushion to support the patient and prevent contamination, thereby improving the patient's bed comfort during the perioperative period. The surgical pad is equipped with a bionic position that fits the curve of the human body. The bionic position can be configured as a curved surface structure with different degrees of concavity, so that the bionic position can support the patient's posture and facilitate maintaining a stable position during treatment or surgery; at the same time, the bionic position can also form a space for accommodating the patient's urine discharge based on the concave structure set at the patient's buttocks. It can be suitable for patients of different genders who are inconvenient to have a catheter inserted, significantly improving the applicability of urine collection.

[0013] During complex coronary interventional procedures or radiofrequency ablation procedures for atrial fibrillation, in order to prevent the injected drugs or contrast agents from causing kidney damage to the patient's kidneys and thus acute renal failure, the patient is encouraged to urinate in bed and needs to continuously test specific urine indicators, such as urine volume per unit time and physiological indicators related to renal failure or heart failure in the urine, such as turbid appearance, dark color or absolute blood creatinine value. However, existing collection and monitoring devices or systems are mostly based on collection and transfer detection methods and are not suitable for continuous monitoring of physiological indicators related to renal failure or heart failure during surgery. During long surgical procedures or procedures with large injection volumes, patients are prone to frequent urination or urinary incontinence due to the effects of anesthesia or injected drugs. Therefore, it is very important to effectively collect and control the collection and flow of urine. The present application forms an extracorporeal bladder for the patient based on the structural setting of the surgical pad. The extracorporeal bladder can convert the patient's intermittent urine excretion mode into a controlled state, so that the extracorporeal bladder can selectively circulate according to the needs of the monitoring module and adjust the detection frequency according to the surgical progress or historical data.

[0014] Therefore, the solution proposed in the present invention is based on monitoring the concentration of acute kidney injury markers in the patient's urine or detecting other components in the urine to obtain relevant instructions for controlling the injection status of the drug solution or contrast agent injected into the patient's body, which can significantly reduce the probability of patients developing acute renal failure during surgery. The effective detection of the concentration of acute kidney injury markers and other parameters in urine can also provide support for the patient's water chemotherapy to ensure the surgical status and alleviate the risk of renal failure.

[0015] In addition, in response to the problem that existing urine collection devices cannot realize automatic urine monitoring during the urine collection process, the present application provides a monitoring module. When the collection module collects urine and transmits it to the monitoring module based on a pipeline, the monitoring module monitors the urine flow based on the flow component, and can obtain relevant information about the patient's urine excretion volume and urine excretion dynamics. In order to realize the sampling of the patient's mid-stream urine, the monitoring module is provided with a main pipe and a sampling tube controlled by a valve. The main pipe is used to circulate most of the urine. With the assistance of the sensor, the sampling tube can intercept the patient's mid-stream urine from the main pipe based on the valve control and obtain a quantitative urine sample through several sampling ports connected to the sampling tube. The several sampling ports can be used as sample storage for different urine detection items. Storage position, when the urine in the sampling tube is emptied, the urine at the sampling port is controlled to fall to the test position of the monitoring unit, and a urine testing kit is arranged on the test position. The urine testing kit passes through the test position in sequence under the action of the kit conveying component to complete several urine tests. The urine testing kit after the reaction is subjected to image acquisition at the test position to obtain the test results of the urine components, thereby realizing the automatic operation of urine collection and monitoring; in order to improve the accuracy of urine testing and prevent urine from contaminating other parts of the urine testing kit, a protective layer is also provided between the sampling port and the test position, the protective layer can limit the channel position of urine falling from the sampling port, so that the urine at the sampling port can accurately fall on the urine testing kit area on the test position to ensure the effectiveness of the test.

[0016] When the collection module and the monitoring module are stably collecting the urine discharged by the patient, the analysis module used to control the active parts of the collection module and the monitoring module can obtain urine-related information such as the patient's urine discharge volume, urine discharge dynamics, and urine composition. Combined with the patient's blood pressure, heart rate, osmotic pressure, patient weight, preoperative fasting time and other physiological data measured by other equipment, the patient's body fluid status can be clarified, and the body fluid management unit can be assisted in determining the relevant parameters for the patient's body fluid replenishment based on the urine-related information and physiological data. The relevant parameters can be the total amount of replenishment, the replenishment speed, the component ratio, etc.; the system of the present application can realize automatic urine collection and monitoring during the perioperative period or during surgery and assist in the patient's body fluid management, which can significantly improve the effective grasp and fine management of the patient's body fluid status during the perioperative period or long-term surgery, so that the patient can maintain a stable and adaptive physiological state to improve the surgical treatment effect.

[0017] Preferably, when the monitoring module is capable of measuring the concentration of acute kidney injury markers in the patient's urine collected by the collection module in an online monitoring manner, the analysis module issues an early warning prompt and / or controls the injection status of the contrast agent pumping mechanism in response to a trigger signal related to the comparison result of the acute kidney injury marker concentration with several set thresholds and / or the rate of change of the acute kidney injury marker concentration.

[0018] Preferably, the analysis module is configured with a calculation unit and a body fluid management unit. The calculation unit obtains body fluid management parameters based on the urine output and urine test results obtained by the monitoring module and combined with the patient's physiological parameters to control the body fluid management unit to perform patient body fluid replenishment management.

[0019] Preferably, the monitoring module includes a sampling unit equipped with a main pipe and a sampling tube, the sampling unit is provided with a flow component for detecting the amount of urine discharged and performs quantitative sampling of the patient's urine based on the sampling port connected to the sampling tube; the sampling tube includes a curved section and a straight section, the straight section is connected to the main pipe through the curved sections arranged at both ends, the sampling tube is provided with a plurality of sampling ports in the straight section, the sampling ports are configured as a double-opening space that fits the lower edge of the sampling tube, the upper end of the sampling port is connected to the sampling tube, and the lower end of the sampling port is connected to the sampling valve; the sampling port can retain a quantitative urine sample when the urine passes through the sampling tube, and after the urine circulation in the sampling tube is completed, the urine remaining in the sampling port can be used as a test object for different urine detection items.

[0020] Preferably, the detection unit is configured with a urine test kit arranged in a sequence, the urine test kit being composed of a plurality of identically sized test kit units, such that the urine test kit is transported in a sequence under the action of the test kit transport assembly, wherein the distance from the testing position to the imaging position is an integer multiple of the lengths of the plurality of test kit units. The urine test kit is configured with a plurality of identically sized test kit units, with different test kit units sequentially passing through the testing position and the imaging position, thereby completing the process of urine sampling reaction and test kit reaction pattern acquisition, resulting in a sequential arrangement of the urine test kit, wherein the distance from the testing position to the imaging position is configured as an integer multiple of the test kit unit length, enabling the test kit units to be aligned with the testing position or the imaging position, thereby ensuring accurate test results.

[0021] Preferably, the detection unit is provided with a camera assembly for capturing images of the urine test kit above the camera position. The camera assembly is connected to a sliding track that can move in the conveying direction of the urine test kit, so that the camera assembly can adjust the arrangement position of the camera position in the conveying direction of the urine test kit based on the sliding track and change the distance between the camera position and the test position. If the previous test kit unit is in the reaction time and the patient has a new round of urination, after the new round of sampling is completed, the camera assembly follows the previous test kit unit in the conveying direction by the length of one test kit unit via the sliding track. After the previous test kit unit reaches the reaction time and the camera assembly captures image information, the camera assembly moves in the opposite direction of the conveying direction by the length of one test kit unit so that the camera assembly is aligned with the current test kit unit. The setting of the camera assembly can cope with the situation of short urination intervals, leaving ample time for the test kit to react with urine.

[0022] Preferably, the monitoring module is further configured with a storage unit and a cleaning unit. The storage unit includes a urine storage tank for storing the patient's urine. The cleaning unit is used to automatically and closed clean the pipeline channel of the monitoring module. The storage unit is configured with a corresponding cleaning liquid storage tank and a cleaning liquid recovery tank. The urine storage tank, the cleaning liquid storage tank, and the cleaning liquid recovery tank are equipped with liquid level sensors for liquid level monitoring. At least one of the urine storage tank, the cleaning liquid storage tank, and the cleaning liquid recovery tank is configured as an integrally replaceable structure. The integrally replaceable structure avoids the diffusion contamination caused by the open valve outlet setting, ensures the closed nature of the urine processing process, improves the cleanliness of the urine processing, and improves the surgical environment.

[0023] Preferably, the main pipe of the sampling unit is equipped with a cleaning liquid injection pipe near the flow assembly. If the main pipe is equipped with a main pipe bypass pipe, the sampling pipe is equipped with a sampling bypass pipe near the sampling port. The horizontal pipes in the sampling unit and the cleaning unit are arranged with an inclination in the direction of flow. The inclined horizontal pipe arrangement ensures smooth flow of liquid without accumulation.

[0024] Preferably, the bionic position is configured with a concave curved surface structure corresponding to the human body curve, especially at the patient's urinary organ and buttocks. The bionic position is equipped with a support layer that fits the curve of the buttocks and a groove for accommodating urine. The support layer is arranged above the groove, with a lowest point in the middle of the upper part of the support layer. The upper surface of the support layer is arranged with several lines pointing to the lowest point, allowing urine to flow into the groove through the through holes set in the support layer. A connecting component for draining urine is provided at the bottom of the groove. The connecting component includes a diversion tube connected to the bottom opening of the groove. The diversion tube is equipped with a negative pressure valve that enables one-way flow of urine and air.

[0025] The present application also provides a urine collection monitoring method, which is implemented based on the aforementioned urine collection monitoring system and includes the following steps:

[0026] The body fluid management unit obtains body fluid management parameters based on the physiological information collected by the analysis module. The physiological information includes: urine output, urine test results, blood pressure, heart rate, osmotic pressure, patient's preoperative fasting time, patient weight and other parameters. The body fluid management parameters include total replenishment, replenishment speed, and replenishment component ratio; the total replenishment amount is composed of the superposition of physiological maintenance amount, trauma replenishment amount, urination replenishment amount and balance replenishment amount; the first replenishment speed of physiological maintenance amount remains basically unchanged during the operation, which is used to balance the amount of fluid lost by the patient's skin, respiration, etc.; the second replenishment speed of trauma replenishment amount is adjusted according to the surgical specifications to balance the amount of body fluid lost in the surgical area; the third replenishment speed of urination replenishment amount is determined according to urine output; the fourth replenishment speed of balance replenishment amount is determined by the patient's physiological information to balance the first three replenishment methods, so that the patient can maintain stable physiological indicators; the replenishment component ratio is the ratio of crystalloid fluid and colloid fluid. The balanced replenishment amount is mainly based on the patient's blood pressure and heart rate to determine the fourth replenishment speed. When the blood pressure drops and the heart rate rises, it means that the patient's blood volume decreases. The difference between the current blood pressure, heart rate and the average value of the preoperative state is obtained, so that the fourth replenishment speed is positively correlated with the absolute value of the difference.

[0027] Preferably, when the concentration of the acute kidney injury marker determined by the calculation unit of the analysis module according to the monitoring module exceeds a first threshold value as the upper limit of the normal concentration range, the early warning unit of the analysis module issues a first warning, wherein a pre-deceleration prompt related to the exceeding of the first threshold value is issued to the contrast agent pumping mechanism via the communication unit; when the concentration of the acute kidney injury marker determined by the calculation unit of the analysis module according to the monitoring module exceeds a second threshold value as the upper limit of the normal concentration range, the early warning unit of the analysis module issues a second warning, and at the same time, a stop pumping instruction related to the exceeding of the second threshold value is issued to the contrast agent pumping mechanism via the communication unit; and / or a hydration therapy recommendation is provided via the body fluid management unit; the analysis module determines whether to send a pre-deceleration prompt to the pumping mechanism via the communication unit by determining the derivative of the change of the acute kidney injury marker concentration collected several times before and after, especially in two urinations, wherein the judgment process based on the change derivative adopts a more sensitive acute kidney injury marker concentration detection method than the judgment process based on the threshold value.

[0028] Preferably, the calculation unit is connected to the communication component, and the calculation unit obtains the flow state of the diversion tube through a flow sensor arranged on the inner side of the diversion tube and controls the working state of the negative pressure valve accordingly. When urine starts to flow in the diversion tube, the negative pressure valve starts to operate at a first power, so that the diversion tube reaches a first negative pressure value; when the urine flow in the diversion tube ends, the negative pressure valve continues to operate at the first power for a hysteresis time, and then the negative pressure valve switches to a second power for operation; the first power, the second power and the hysteresis time can be manually set according to the interactive unit, or several negative pressure gears can be set, so that the first power, the second power and the hysteresis time can be set to multiple gears from large to small to adapt to the negative pressure working intensity requirements in different situations.

[0029] Preferably, the calculation unit is connected to the sampling unit, the monitoring unit and the cleaning unit, and the calculation unit obtains the flow information of the flow component. The flow information can be a function of the volume flow and time, and is displayed by the interactive unit as a curve of the volume flow changing over time; the functional performance of the patient's urinary system can be obtained from the changing curve, that is, the relevant information of the urination rhythm, urine flow and urine stage changes can be obtained through the relationship between the volume flow and time, which can be used to evaluate the control ability of the kidneys and bladder muscles; the urine excretion in a period of time can be obtained by integrating the volume flow within a period of time, and the urine excretion can be used to guide the input parameters for replenishing body fluids, such as the total input amount, input speed and other information.

[0030] Preferably, the image information of the urine testing kit is displayed in sequence by the interactive unit, that is, the information of several urine testing kits is arranged into several scrolling subtitle-style sequences according to different test items. The sequence can be arranged horizontally or vertically, and the image information of different kit units in the sequence is annotated with test time and test result identification. The test time can be absolute time or relative time based on the start of the operation; the test result identification is one or more of the following symbols: Chinese, English, image or color.

[0031] The present application also provides a renal failure control system based on urine monitoring, the system including: a collection module for collecting urine discharged by the patient; a monitoring module for sampling and monitoring the patient's urine obtained by the collection module; an analysis module for controlling the injection management and / or hydration therapy management of the contrast agent based on the monitoring module's detection of the patient's urine components and / or markers in the urine; wherein, when the monitoring module is capable of measuring the concentration of acute kidney injury markers in the patient's urine collected by the collection module in an online monitoring manner, in response to a trigger signal of a comparison result of the acute kidney injury marker concentration with several set thresholds and / or the rate of change of the acute kidney injury marker concentration, the analysis module issues an early warning prompt and / or controls the injection status of the contrast agent pumping mechanism.

[0032] During complex coronary interventional surgeries or radiofrequency ablation surgeries for atrial fibrillation, in order to prevent the injected drug or contrast agent from causing kidney damage to the patient's kidneys and leading to acute renal failure, the patient is encouraged to urinate in bed and needs to continuously test specific urine indicators, such as urine volume per unit time and physiological indicators related to renal failure or heart failure in the urine, such as turbid appearance, dark color or absolute blood creatinine value. However, existing collection and monitoring devices or systems are mostly based on collection and transfer detection methods and are not suitable for continuous monitoring of physiological indicators related to renal failure or heart failure during surgery. Therefore, the solution proposed in the present invention is based on monitoring the concentration of acute kidney injury markers in the patient's urine or detecting other components in the urine to obtain the injection status for controlling the injection of drug or contrast agent into the patient's body. The injection status includes injection rate, injection cycle, drug configuration category, etc.

[0033] Among specific urine indicators, relatively sensitive markers of acute kidney injury (AKI) include neutrophil gelatinase-associated lipocalin (NGAL). When AKI occurs, NGAL concentrations rise dramatically within a short period of time. For example, within 2 hours, the increase can be tens to hundreds of times higher than the critical value. To ensure accurate diagnosis and timely intervention of acute renal failure, the present application monitors and analyzes the absolute and relative changes in the concentration of acute kidney injury markers in urine to obtain the injection status used to guide the contrast agent pump control structure. The absolute change is the result of comparing the acute kidney injury marker concentration with several set thresholds. For example, the normal concentration range of the acute kidney injury marker NGAL in urine is 0.7-9.6 ng / mL. The absolute change can represent the degree to which the patient's current urine acute kidney injury marker concentration deviates from the normal range. The relative change refers to the rate of change in the acute kidney injury marker concentration. The relative change can be used to represent the development trend of the patient's current urine acute kidney injury marker concentration, that is, the rate of change from the normal range. The combined monitoring of the relative and absolute change rates can effectively determine the development trend and degree of the patient's kidney damage. Especially when the concentration change of the acute kidney injury marker NGAL is more significant, the detection and identification of early development trends can effectively control the injection of drug solutions or contrast agents, significantly reducing the probability of acute renal failure in patients during surgery. At the same time, effective detection of acute kidney injury marker concentrations and other parameters in urine can also provide support for patients' water chemotherapy to ensure surgical status and alleviate the risk of renal failure.

[0034] Preferably, when the concentration of the acute kidney injury marker determined by the calculation unit of the analysis module based on the monitoring module exceeds a first threshold value, which is the upper limit of the normal concentration range, the early warning unit of the analysis module issues a first warning, wherein preferably, the communication unit issues a pre-deceleration prompt related to the exceeding of the first threshold value to the contrast agent pumping mechanism. This pre-deceleration prompt is very important for the normal operation of the contrast agent pumping mechanism for the following two reasons: first, the viscosity of the contrast agent is sensitive to temperature. If it is not preheated to body temperature before being inhaled into the pump, the infusion pump body itself may be damaged due to excessive viscosity; second, the contrast agent needs to be stored away from light. Therefore, the pre-deceleration instruction can reserve control time for the contrast agent pumping mechanism to prevent contrast agent with fluctuating viscosity from being retained in the pipeline and causing damage to the pumping mechanism or degradation and failure of the contrast agent.

[0035] Preferably, when the concentration of the acute kidney injury marker determined by the calculation unit of the analysis module based on the monitoring module exceeds a second threshold value, which serves as the upper limit of the normal concentration range, the early warning unit of the analysis module issues a second warning and simultaneously issues a pumping stop instruction related to the exceeding of the second threshold value to the contrast agent pumping mechanism via the communication unit; and / or provides hydration therapy recommendations via the body fluid management unit. With the onset of renal failure, NGAL concentrations can soar tens or even hundreds of times within a short period of time (within 2 hours). If this trend is not detected immediately, irreversible damage can occur. Therefore, a safety threshold is set based on the absolute degree of change to enable interventional control in the early stages of NGAL concentration changes, avoiding untimely interventional control during the NGAL concentration surge phase or worsening of renal failure. Simultaneously, water infusion chemotherapy is used to alleviate the progression of renal failure, thereby significantly reducing the patient's probability of developing renal failure during surgery.

[0036] Preferably, the analysis module determines whether to send a pre-deceleration prompt to the pumping mechanism via the communication unit by determining the derivative of the change in acute kidney injury marker concentration collected during several consecutive urinations, particularly two urinations. The determination process based on the derivative utilizes a more sensitive acute kidney injury marker concentration detection method than a threshold-based determination process. For example, the acute kidney injury marker may be NGAL, and the sensitivity of the second NGAL paired antibody used in the derivative determination is higher than the sensitivity of the NGAL paired antibody used in the threshold determination. Given that a "sharp increase in NGAL concentration over a short period of time" is more important to patients receiving contrast agents, rather than the NGAL concentration itself, the calculation unit of the analysis module can determine the NGAL concentration change based on the change in urine NGAL concentration. This relative change can be used to determine the NGAL concentration trend, thereby enabling earlier detection of NGAL concentration spikes and thereby minimizing contrast agent-induced renal failure.

[0037] Preferably, the interaction unit, communication unit, and fluid management unit of the analysis module can respectively issue prompts or instructions to the current surgeon or other doctors or other related equipment in the case of a pre-deceleration prompt related to exceeding the first threshold value or in the case of a pre-deceleration prompt related to a significant increase in the derivative; for example, they can notify a nephrologist to provide guidance on rescuing a patient with renal failure, or they can manage the patient's fluid status through the fluid management unit, such as providing hydration therapy recommendations. After the concentration of the acute kidney injury marker returns to the normal range, the analysis module eliminates the pre-deceleration prompt and, at the same time, the communication unit sends a restart instruction related to the elimination of the pre-deceleration prompt to the contrast agent pumping mechanism. The early or advance issuance of the restart instruction is beneficial for the contrast agent temperature rise, and can significantly shorten the preparation period for contrast agent application, which is of great significance for complex coronary intervention surgeries where every second counts.

[0038] Preferably, the collection module includes a surgical pad configured with a bionic position, which provides a urine collection structure for the patient based on the bionic position. For example, at the patient's urinary organ and buttocks, the bionic position is configured with a support layer that fits the curve of the buttocks and a groove for accommodating the support layer. The surgical pad is also configured with a bottom collection part, which forms an external bladder for the patient in a manner that can collect pre-stored patient urine, wherein the external bladder can selectively provide urine to the downstream monitoring module, and the provision of urine is implemented based on the patient's urination time as a gating instruction. Specifically, the support layer is provided with through holes for urine circulation, and the groove is provided at the bottom of the support layer for temporarily storing urine. The multiple through holes are distributed in a concentric circle on the surface of the support layer close to the patient on the side facing the patient. They extend in a spiral downward manner within the support layer with the bottom collection part as the center and finally connect to the bottom collection part at the end. The pipes formed by the multiple through holes are respectively located inside the support layer in the form of multiple groups of spiral coil springs, so that the hardness of the pipes themselves and the spiral shape constitute the spring structure inside the support layer. Among them, the bottom collecting part constitutes a dome-shaped component that can be positioned within the support layer after installation, and the bottom collecting part itself forms an internal hollow flying saucer shape.

[0039] For long surgical procedures or procedures with large injection volumes, patients are prone to frequent urination or urinary incontinence due to the effects of anesthesia or injected drugs. Therefore, it is very important to effectively collect and control the collection and flow of urine. The present application forms an external bladder for the patient based on the structural setting of the surgical pad. The external bladder can transform the patient's intermittent urine discharge into a controlled state, so that the external bladder can selectively circulate according to the needs of the monitoring module and adjust the detection frequency according to the progress of the operation or historical data. On the basis of effectively collecting urine, the collection module also needs to provide good support for the patient. By designing the materials of the through-holes and the support layer, for example, the area where the through-holes are used to wrap the support layer adopts a surface setting that allows the two to slide relative to each other, and the area where the support layer is used to wrap the through-holes adopts multiple transition layers from hard to soft. That is, through the above setting, an internal surface support can be obtained as a whole, without producing a locally protruding hard core, so that the support layer can evenly support the patient and ensure that each pipeline can smoothly collect urine. The support layer and the bottom collection part can also be modularly assembled based on a detachable structure. The saucer-shaped hollow bottom collection portion acts as a replaceable "extracorporeal bladder," temporarily storing urine and isolating it from the support layer. After replacing the bottom collection portion and the through-hole tubing, the support layer can be reused after disinfection, such as by washing, soaking, and / or UV irradiation. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 It is a schematic diagram of the overall structure of a preferred embodiment of the present invention;

[0041] Figure 2 This is a schematic diagram of the monitoring module structure of a preferred embodiment of the present invention;

[0042] Figure 3 This is a schematic diagram of the partial structure of a monitoring module according to a preferred embodiment of the present invention;

[0043] Figure 4 It is a functional connection diagram of a preferred embodiment of the present invention.

[0044] Reference Signs List

[0045] 100: Collection module; 101: Surgical pad; 1011: Bionic position; 1012: Support layer; 1013: Charging and discharging component; 1014: Through hole; 1015: Bottom collection part; 102: Urine collection component; 103: Connecting component; 1031: One-way component; 1032: Negative pressure valve; 1033: Diversion tube; 200: Monitoring module; 201: Sampling unit; 2011: Flow component; 2012: Main pipe; 2013: Three-way valve; 2014: Sampling pipe; 2015: Sampling port; 2016: Sampling valve; 2017: Main pipe control valve; 202: Detection unit; 2021: Reagent kit delivery component; 2022: Test Position; 2023: Protective layer; 2024: Camera assembly; 2025: Reagent kit storage position; 2026: Urine test kit; 203: Storage unit; 2031: Urine storage tank; 2032: Cleaning liquid storage tank; 2033: Cleaning liquid recovery tank; 204: Cleaning unit; 2041: Main bypass pipe; 2042: Sampling bypass pipe; 2043: Main bypass valve; 2044: Sampling pipe bypass valve; 2045: Cleaning pump; 2046: Cleaning liquid injection pipe; 300: Analysis module; 301: Computing unit; 302: Interaction unit; 303: Communication unit; 304: Early warning unit; 305: Body fluid management unit. DETAILED DESCRIPTION

[0046] The present invention will be described in detail below with reference to the accompanying drawings.

[0047] Example 1

[0048] Figure 1 A first embodiment of the urine collection monitoring system of the present invention is shown.

[0049] The system includes a collection module 100 configured to collect urine from perioperative patients. Especially in the case of long operations where it is inconvenient to insert a catheter, the collection module 100 provides a structure for the lying patient to maintain a stable posture through a surgical pad 101 set on the operating bed; the surgical pad 101 is provided with a urine collection component 102 detachably connected to the surgical pad 101 at a position close to the patient's urination, and the urine collection component 102 is used to guide the urine discharged by the patient to a connecting component 103; the connecting component 103 is used to connect the collection module 100 and the monitoring module 200, wherein the monitoring module 200 can assist the analysis module 300 in performing body fluid management during the perioperative period or operation by detecting the patient's urine volume and urine composition.

[0050] Preferably, if Figure 1 As shown, the collection module 100 includes a surgical pad 101 that can be placed on an operating table. For ease of illustration, the thickness of the surgical pad 101 is exaggerated compared to other components. It should be understood that this figure is not intended to limit its specific thickness.

[0051] according to Figure 1 The surgical pad 101 is equipped with a bionic position 1011 that fits the human body curve. The bionic position 1011 has a corresponding concave curved surface structure based on the human body curve. The bionic position 1011 can keep the patient's position stable during the operation. The concave curved structure can also form a structure to accommodate the liquid generated during the operation to avoid contaminating the operating bed.

[0052] according to Figure 1 The bionic position 1011 can also be combined with breathable and warming devices to enhance the patient's lying comfort and avoid bedsores caused by long-term bed rest. The bionic position 1011 is equipped with different curved bearing areas according to changes in body shape, especially in the patient's urinary organs and buttocks. The bionic position 1011 is equipped with a support layer 1012 that fits the buttocks curve and a groove for accommodating urine.

[0053] according to Figure 1 The support layer 1012 of surgical pad 101 is positioned above the groove of bionic position 1011, allowing the upper portion of support layer 1012 to be adjacent to or in contact with the patient's buttocks and thighs. To ensure the groove's ability to collect urine, the upper surface of support layer 1012 is provided with several internal grooves (pathways) pointing toward the lowest point, allowing urine to flow into the groove through through-holes 1014 provided within support layer 1012.

[0054] The bottom of the groove of surgical pad 101 is provided with a bottom collecting portion 1015. When viewed from above, multiple through-holes 1014 are arranged concentrically on the patient-facing side. They spiral downward within support layer 1012, centered around bottom collecting portion 1015, ultimately connecting to bottom collecting portion 1015 at their ends. Each pipeline forms a threaded conduit within support layer 1012, extending from the top of support layer 1012 to bottom collecting portion 1015. The angle through which each threaded conduit spirals around bottom collecting portion 1015 is less than 180°, particularly less than 120°, and even more preferably less than 90°. This ensures that the axial projections of the multiple threaded conduits overlap by less than 30°, particularly less than 15°. Most preferably, the axial projections of the multiple threaded conduits are spaced apart, i.e., by an angle of less than 10°, or less than 5°. By arranging multiple threaded pipes at intervals, the areas where pressure is concentrated are reduced within each threaded pipe and the surrounding structures during pressure-bearing period, especially avoiding the situation where two rigid pipes intersect with each other and are crushed and unable to flow on the patient side of the bottom collection part 1015.

[0055] Preferably, a plurality of openings are provided on a side of the multi-channel threaded pipe facing the supporting layer 1012 , wherein these openings form a plurality of urine collecting ports widely distributed along the upper surface of the surgical pad 101 .

[0056] Preferably, the tubing in through-hole 1014 is constructed of a significantly harder material. Preferably, while selecting an appropriate material hardness, the tubing's diameter-to-length ratio is adjusted to achieve a tubing whose lumen is not completely compressed by the patient's weight. Multiple tubings are positioned within support layer 1012 in the form of multiple coil springs arranged in a spiral configuration. The hardness of the tubing itself and its coiled configuration together form the spring structure within support layer 1012, enabling overall support for patients weighing 50 to 150 kg without causing tubing compression and urine retention.

[0057] Preferably, by designing the materials of the through hole 1014 and the support layer 1012, for example, the area of ​​the through hole 1014 used to wrap the support layer 1012 adopts a surface setting that allows the two to slide relative to each other, and the part of the support layer 1012 used to wrap the through hole 1014 adopts multiple transition layers from hard to soft (when viewed from the direction close to the through hole to the direction away from the through hole). Through the above settings, it is generally possible to obtain a planar support inside, without producing a hard core that protrudes upward in the axial direction, and it can also ensure that each pipeline can smoothly collect urine; and more importantly, these pipelines forming the through hole 1014 will not get stuck in the support layer 1012 even after many hours of use, but can still be replaced. In addition, the replaceability of the through hole 1014 is also supported by "multiple transition layers from hard to soft when viewed from the direction close to the through hole to the direction away from the through hole."

[0058] Preferably, after installation, the bottom collecting portion 1015 forms a dome-shaped component that can be positioned within the support layer 1012 (the dome is located on the side away from the patient during use). In other words, the bottom collecting portion 1015 itself is shaped like a hollow flying saucer. The bottom collecting portion 1015 can be supported by the side of the surgical pad 101 facing the support layer 1012, but can also be pre-assembled with the support layer 1012 by snap-fit ​​connection (e.g., male-female fit) to form a pre-assembled component.

[0059] Preferably, the side of the bottom collecting portion 1015 closest to the patient is provided with an interface for connecting to the tubing of the through-hole 1014. The side of the bottom collecting portion 1015 facing away from the patient forms the bottom of a recessed groove. In operation, the hollow, saucer-shaped bottom collecting portion 1015 functions as a replaceable "extracorporeal bladder," temporarily storing urine and isolating the urine from the support layer 1012. After replacing the bottom collecting portion 1015 and the tubing forming the through-hole 1014, the support layer 1012, after being disinfected (e.g., by washing, soaking, and / or ultraviolet irradiation), can be reused.

[0060] like Figure 1As shown, the surgical pad 101 can also be provided with a urine collection component 102 for controlling the direction of urination, and the urine collection component 102 is detachably connected to the surgical pad 101 through an adhesive structure. Specifically, the urine collection component 102 is respectively connected to the left side of the support layer 1012, the right side of the support layer 1012 and the lower end of the support layer 1012 through the adhesive structure, wherein the left side of the support layer 1012 is the left side of the patient's buttocks, the right side of the support layer 1012 is the right side of the patient's buttocks, and the lower end of the support layer 1012 is the position between the patient's legs, so that the urine collection component 102 can cover the patient's urination outlet based on the trouser-type structure, so that the discharged urine can be collected in the middle area of ​​the support layer 1012 under the constraint of the urine collection component 102 and flow into the through hole, so that the urine collection component 102 can be applied to both male and female patients in the urination restraint process without catheter insertion. The urine collecting component 102 is detachably connected to the surgical pad 101 so that the urine collecting component 102 can be set as a disposable item, and the supporting layer 1012 can also be set as a detachable structure to facilitate installation, adjustment, cleaning and disinfection; the surgical pad 101 is set as an inflatable and deflation structure, and the inflation and deflation part 1013 for inflation management can be configured as a manual inflation mode or an electric inflation mode. The surface of the surgical pad 101 is made of hydrophobic material.

[0061] Preferably, a connecting component 103 for draining urine is provided at the bottom of the groove. Preferably, the connecting component 103 can be used to provide urine temporarily stored in the bottom collection part 1015 to downstream monitoring and analysis modules for determining physiological data related to renal failure or heart failure.

[0062] To this end, the connecting component 103 includes a guide tube 1033 connected to the bottom opening of the groove, and the guide tube 1033 is provided with a one-way piece 1031 for achieving one-way flow of urine near the opening, wherein a flow sensor is provided downstream of the one-way piece 1031.

[0063] Preferably, the one-way member 1031 can be a valve structure that can be opened and closed at a fixed time or a one-way valve that opens periodically according to a timing unit; or it can be a valve structure or a one-way valve that opens and closes according to an external instruction.

[0064] Preferably, a negative pressure valve 1032 preferably located downstream of the one-way member 1031 may be further provided in the guide tube 1033 so that the negative pressure valve 1032 can achieve one-way flow or pressure relief of air during the patient's urination period or urination interval.

[0065] In addition to collecting urine, the present invention also focuses on the control of contrast agent dosage. Contrast agent is one of the important causes of renal failure. Although continuous pumping of contrast agent is widely used for angiography instead of artificial injection of contrast agent, the incidence of contrast-induced nephropathy has been significantly reduced (because an analysis of 79,694 patients in the prior art found that continuous pumping of contrast agent for angiography can reduce the contrast agent dose by 45 ml compared with artificial injection of contrast agent, and reduce the incidence of contrast-induced nephropathy by 15%, so in order to reduce the amount of contrast agent, continuous pumping rather than artificial injection is generally recommended); but calculating the amount of contrast agent based on body weight or body surface is still a common clinical practice. In order to further limit the occurrence of contrast-induced nephropathy, the present invention proposes the use of a urine monitoring module 200 (see Figure 1 ), which can measure acute kidney injury (AKI) markers, such as neutrophil gelatinase-associated lipocalin (NGAL), in the urine flowing out through the drainage tube 1033 in an online monitoring manner.

[0066] According to a preferred embodiment, when the concentration of an acute kidney injury (AKI) marker, such as NGAL, determined by the calculation unit 301 of the analysis module 300 based on the monitoring module 200 exceeds a first threshold value (e.g., 9 ng / ml), which represents the upper limit of the normal concentration range, the early warning unit 304 of the analysis module 300 issues a first warning and simultaneously issues a pre-deceleration prompt related to the first threshold value exceeded to the contrast agent pumping mechanism via the communication unit 303. This pre-deceleration prompt is crucial for the proper functioning of the contrast agent pumping mechanism for two reasons: first, the viscosity of contrast agent is sensitive to temperature; if it is not preheated to body temperature before being drawn into the pump, the excessive viscosity may damage the infusion pump itself; and second, contrast agent must be stored away from light. Therefore, if the threshold value is exceeded and the communication unit 303 of the analysis module 300 issues a shutdown command, the infusion pump system must implement a series of temporary protective measures to ensure that no contrast agent remains in the pump or in the tubing (otherwise, the infusion pump may be damaged during a cold start-up or the contrast agent may degrade or fail due to prolonged exposure to light). When the concentration of an acute kidney injury (AKI) marker, such as NGAL, determined by the calculation unit 301 of the analysis module 300 based on the monitoring module 200 exceeds a second threshold value (e.g., 10 ng / ml), which is the upper limit of the normal concentration range, the early warning unit 304 of the analysis module 300 issues a second warning. Simultaneously, a pumping stop instruction related to the exceeding of the second threshold is sent to the contrast agent pumping mechanism via the communication unit 303, and / or a hydration therapy recommendation is provided via the fluid management unit 305. This is because with the onset of renal failure, NGAL concentrations can soar by tens or even hundreds of times within a short period of time (e.g., within 2 hours). If this trend is not detected immediately, irreversible damage may occur.

[0067] Preferably, given that a "sharp increase in NGAL concentration over a short period of time" rather than the NGAL concentration itself is more important for patients receiving contrast agents, the calculation unit 301 of the analysis module 300 can determine the change in NGAL concentration based on the change in urinary NGAL concentration. Preferably, the calculation unit 301 determines whether to send a pre-deceleration prompt to the pumping mechanism via the communication unit 303 by determining the derivative of the NGAL concentration change collected during several consecutive urinations, particularly two urinations. Determining the trend of NGAL concentration change using the derivative allows for earlier detection of a surge in NGAL concentration, thereby minimizing contrast agent-induced renal failure. Compared to the sensitivity of the NGAL paired antibody used in threshold determination, the sensitivity of the second NGAL paired antibody used in derivative determination is significantly higher. For example, the sensitivity of the first NGAL paired antibody is less than or equal to 0.125 ng / mL, while the sensitivity of the second NGAL paired antibody is less than or equal to 0.08 ng / mL.

[0068] In particular, when NGAL concentration fluctuates near the upper limit of the normal concentration range (e.g., 9-15 ng / ml), determining the NGAL concentration trend using the concentration derivative can significantly reduce false alarms and avoid interference with complex surgical procedures. However, in the case of sudden concentration changes, when both the NGAL concentration curve variable (the numerator of the limiting function) and the time variable (the denominator of the limiting function) approach zero, the calculation unit 301 of the analysis module 300 can still determine the difference between the NGAL concentration derivatives of multiple urinations based on L'Hôpital's rule. If a significant increase in the derivative between two urinations is determined ("significant increase in the derivative" means that although the current concentration only slightly exceeds the threshold, its trend of change will significantly increase within a short period of time), the calculation unit 301 of the analysis module 300 will issue a pre-deceleration warning related to the significant increase in the derivative (similar to the aforementioned warning related to exceeding the first threshold). According to the present invention, the pre-deceleration warning related to the significant increase in the derivative can effectively prevent renal failure because it can quickly identify a surge in NGAL concentration by tens or even hundreds of times. In the case where the NGAL concentration fluctuates near the upper limit of the normal concentration range (e.g., 9-15 ng / ml), in order to determine the concentration derivative mutation with higher accuracy, the second NGAL paired antibody sensitivity, or another NGAL paired antibody sensitivity that is smaller than the second NGAL paired antibody sensitivity, is used.

[0069] Preferably, the interaction unit 302, the communication unit 303 and the body fluid management unit 305 of the analysis module 300 can respectively issue prompts or instructions to the current surgeon or other doctors or other relevant equipment in the case of a pre-deceleration prompt related to exceeding the first threshold or in the case of a pre-deceleration prompt related to a significant increase in the derivative, for example, they can notify a kidney specialist to give guidance on rescuing a patient with renal failure, or they can manage the patient's body fluid condition through the body fluid management unit 305, such as giving hydration therapy advice.

[0070] Preferably, after the NGAL concentration returns to the normal range, the analysis module 300 can also send a restart instruction related to the elimination of the pre-deceleration prompt to the contrast agent pumping mechanism through its communication unit 303 while eliminating the pre-deceleration prompt. Among them, the early or early issuance of the restart instruction is beneficial to the contrast agent temperature rise, and can significantly shorten the preparation period for applying the contrast agent, which is of great significance for complex coronary intervention surgeries where every second counts.

[0071] Example 2

[0072] Figure 2 A second embodiment of the present invention is provided, wherein, although the contents similar or identical to those of the first embodiment are omitted, the contents are applicable to the second embodiment unless technically contradictory or replaced.

[0073] according to Figure 2 The monitoring module 200 may include a sampling unit 201, a monitoring unit and a storage unit 203. The sampling unit 201 is used to intercept the patient's urine and form at least one sample to be tested, the monitoring unit is used to test the sample to be tested and obtain test results, such as biomarkers for judging renal failure, and the storage unit 203 is provided with a urine storage space, so that the urine collection and monitoring process becomes a continuous closed process, which avoids contamination of the sample and also avoids odor caused by open monitoring in the operating room. Preferably, a corresponding gas outlet may also be provided in the monitoring module 200, and a filter layer and an absorption layer are arranged at the gas outlet position to absorb odor components in the gas.

[0074] like Figure 2 As shown, the monitoring module 200 is provided with an inlet for connecting the flow tube 1033, so that the flow tube 1033 can be detachably connected to the inlet. For example, the connection between the flow tube 1033 and the inlet can be achieved by a Luer connector, thereby allowing urine from the flow tube 1033 to enter the main tube 2012 of the sampling unit 201 through the inlet.

[0075] Preferably, a flow assembly 2011 for monitoring urine flow is provided near the inlet of the main pipe 2012 . The flow assembly 2011 can monitor the volume flow of urine passing through the main pipe 2012 and transmit the flow information to the analysis module 300 .

[0076] Preferably, a sampling tube 2014 is provided after the flow assembly 2011 in the main pipe 2012. The sampling tube 2014 is connected to the main pipe 2012 via a three-way valve 2013, making the sampling tube 2014 a branch of the main pipe 2012. Preferably, the three-way valve 2013 can control the opening of the main pipe 2012 and the sampling tube 2014 respectively. While ensuring smooth urine flow, the three-way valve 2013 controls the direction and timing of the opening of the sampling tube 2014, allowing the sampling tube 2014 to flow sufficient midstream urine to ensure accurate and effective sampling.

[0077] like Figure 2 As shown, the sampling tube 2014 includes a curved section and a straight section. The straight section is connected to the three-way valve 2013 and the main control valve 2017 provided on the main pipe 2012 through the curved sections provided at both ends. The sampling tube 2014 is provided with a plurality of sampling ports 2015 in the straight section. The number of the sampling ports 2015 is set according to the number of urine monitoring items. The sampling ports 2015 are configured as double-opening spaces that fit the lower edge of the sampling tube 2014. The upper end of the sampling port 2015 is connected to the sampling tube 2014, so that the urine flowing through the sampling tube 2014 is 4 can enter the sampling port 2015 through the upper opening of the sampling port 2015. The lower end of the sampling port 2015 is connected to the sampling valve 2016, so that the sampling valve 2016 can control the retention state of urine in the sampling port 2015. The structural setting of the sampling port 2015 can ensure that a certain amount of urine is stored in the sampling port 2015 space. When the sampling hole is filled with the middle part of the urine and the urine in the sampling tube 2014 is emptied, the sampling valve 2016 is opened, and the certain amount of urine remaining in the sampling port 2015 can flow downward into the detection position.

[0078] Preferably, the main pipe 2012 is connected to a storage unit 203 after the main pipe control valve 2017. The storage unit 203 includes a urine storage tank 2031 for storing the patient's urine. A liquid level sensor is provided inside the urine storage tank 2031. The liquid level sensor transmits liquid level information to the analysis module 300. When the liquid level reaches the warning position, the analysis unit issues a processing prompt; the urine storage tank can be set as a replaceable functional block, that is, after the urine storage tank 2031 is stored in the set position, the medical staff can carry a new urine storage tank 2031 for replacement, and seal the replaced urine storage tube for transportation to avoid the valve-open urination design from polluting the operating room environment.

[0079] Preferably, the monitoring module 200 is further provided with a cleaning unit 204, which is used to automatically close the pipeline channel of the monitoring module 200 for cleaning. The storage unit 203 is provided with a corresponding cleaning liquid storage tank 2032 and a cleaning liquid recovery tank 2033. The cleaning liquid in the cleaning liquid storage tank 2032 is pumped into the cleaning liquid injection pipe 2046 based on the action of the cleaning pump 2045. The connection position of the cleaning liquid injection pipe 2046 and the main pipe 2012 is arranged near the flow component 2011 and is located after the flow component 2011, so that the cleaning liquid can pass through the main pipe 2012 and the sampling pipe 2014. The main pipe 2012 is provided with a main bypass pipe 2041 near the inlet of the urine storage tank 2031. Under the control of the main bypass valve 2043, the recovery liquid generated by cleaning flows into the recovery pipe 2014 through the main bypass pipe 2041. The liquid storage tank, the cleaning liquid storage tank 2032 and the recovery liquid storage tank are all equipped with liquid level sensors. When the capacity reaches the warning scale, the analysis unit issues a warning prompt, and the medical staff brings a new cleaning liquid storage tank 2032 and a recovery liquid storage tank for replacement to form a closed treatment; the sampling tube 2014 is provided with a sampling bypass tube 2042 near the sampling port 2015. Under the action of the sampling valve 2016 and the sampling tube bypass valve 2044, the recovery liquid generated by the cleaning liquid in the sampling tube 2014 and the sampling port 2015 flows into the recovery liquid storage tank through the sampling bypass tube 2042; the valves in the monitoring module 200 are all controlled and managed by the analysis module 300 to form channels with different functions. The horizontally arranged pipes in the sampling unit 201 and the cleaning unit 204 can be designed with a certain inclination in the flow direction to avoid liquid accumulation.

[0080] Preferably, if Figure 4 As shown, the detection unit 202 is arranged at the lower part of the sampling unit 201. The detection unit 202 can quickly detect neutrophil gelatinase-associated lipocalin (NGAL) in the patient's urine based on a urine detection kit or test paper, such as a kit using an immunochromatographic method or a colloidal gold method.

[0081] Alternatively, the detection unit 202 may also perform other tests including routine urine tests. For example, a urine analysis kit or test strip may test items including: urine pH, urine glucose, urobilinogen, urine ketone bodies, urine specific gravity, urine occult blood, urine protein, urine nitrite, urine leukocytes, urine ascorbic acid, etc.

[0082] Preferably, the detection unit 202 may include a reagent kit conveying component 2021 for transferring the urine detection reagent kit 2026. The reagent kit conveying component 2021 is configured as a crawler or belt conveying structure, so that the urine detection reagent kit 2026 arranged in the reagent kit storage position 2025 can follow the reagent kit conveying component 2021 to move and pass through the test position 2022 in turn. The test position 2022 is arranged directly below the sampling port 2015, and a protective layer 2023 with a middle hole is provided between the test position 2022 and the sampling tube 2014. The middle hole is arranged directly above the test position 2022 to form a channel allowing urine drops to fall. Specifically, the middle hole can be configured as a circular hole centered on the connecting axis of the test position 2022 and the sampling port 2015. The diameter of the circular hole is smaller than the effective test width of the urine detection reagent kit 2026, so that urine drops can fall into the center of the urine detection reagent kit 2026 placed on the test position 2022 to avoid urine contamination of the reagent kit conveying component 2021.

[0083] Preferably or alternatively, a camera assembly 2024 for capturing image information of the urine testing kit 2026 may be arranged in the direction in which the sampling tube 2014 is moving toward the reagent kit transport assembly 2021. When the urine testing kit 2026 receives urine dripping from the sampling port 2015 at the testing position 2022, the urine testing kit 2026 is moved directly below the camera assembly 2024 by the reagent kit transport assembly 2021. After the reaction time expires, the camera assembly 2024 captures image information of the urine testing kit 2026 and transmits it to the analysis module 300. Based on image recognition, the color change or the appearance of the marking line of the urine testing kit 2026 is confirmed, thereby obtaining the test results corresponding to the item of the current urine testing kit 2026.

[0084] Preferably, to ensure the orderly operation of the system, Figure 4 As shown, the valves and moving parts in the collection module 100 and the monitoring module 200 can be controlled by the analysis module 300 , wherein the analysis module 300 includes a calculation unit 301 , an interaction unit 302 , a communication unit 303 and an early warning unit 304 .

[0085] Preferably, the calculation unit 301 is used to receive flow information or status information obtained by the sensor and transmit control instructions to operating structures such as valves; the interaction unit 302 is used to display information or input control signals; the communication unit 303 is used to obtain human physiological signals measured by other equipment and transmit information related to urine collection and analysis to assist the body fluid management process; the early warning unit 304 is used to transmit system maintenance information or transmit alarm information according to preset parameters.

[0086] Preferably, the calculation unit 301 is connected to the communication component 103, and the calculation unit 301 can obtain the flow state of the diversion tube 1033 through the flow sensor arranged inside the diversion tube 1033 and control the working state of the negative pressure valve 1032 accordingly. For example, when urine begins to flow in the diversion tube 1033, the negative pressure valve 1032 starts to operate at a first power, so that the diversion tube 1033 reaches a first negative pressure value; when the urine flow in the diversion tube 1033 ends, the negative pressure valve 1032 continues to operate at the first power for a period of time, and then the negative pressure valve 1032 is turned off. 1032 is converted to the second power to work, and the time that the negative pressure valve 1032 continues to operate at the first power can be called the hysteresis time. The length of the hysteresis time can be set by the length of the urine flow time, so that the length of the hysteresis time is positively correlated with the urine flow time. Among them, the first power, the second power and the hysteresis time can be manually set according to the interactive unit 302, or a number of negative pressure gears can be set, so that the first power, the second power and the hysteresis time can be set to multiple gears from large to small to adapt to the negative pressure working intensity requirements in different situations.

[0087] Preferably, the calculation unit 301 is connected to the sampling unit 201, the monitoring unit and the cleaning unit 204. The calculation unit 301 obtains the flow information of the flow component 2011. The flow information can be a function of volume flow and time, and is displayed by the interactive unit 302 as a curve of volume flow change over time. The functional performance of the patient's urinary system can be obtained from the change curve, that is, the relevant information of urination rhythm, urine flow and urine stage change is obtained through the relationship between volume flow change and time, which can be used to evaluate the control ability of the kidney and bladder muscles; the volume flow within a period of time is integrated to obtain the urine output of the time period, and the urine output can be used to guide the input parameters for replenishing body fluids, such as the total input amount, input speed and other information.

[0088] Preferably, the calculation unit 301 is connected to the valve of the monitoring module 200, and the flow sensor of the communication component 103 monitors the state of the diversion tube 1033 and transmits it to the calculation unit 301; when the patient is in the non-urination stage, the calculation unit 301 controls the negative pressure valve 1032 to operate at the second power, and the three-way valve 2013 connected to the sampling tube 2014 only opens the direction of the main pipe 2012, the main pipe control valve 2017 only opens the direction of the main pipe 2012, and the bypass control valve only opens the direction of the main pipe 2012, so that the gas transmitted through the diversion tube 1033 enters the urine collection tank through the main pipe 2012. The urine collection tank is designed with an exhaust hole, and the exhaust hole is arranged with an absorption layer for eliminating odor, so that the gas discharged from the urine collection tank will not pollute the environment in the operating room. The absorption layer is designed as a replaceable functional block, which is replaced after a certain period of operation to ensure the gas treatment effect; when the patient is in the urination stage, the negative pressure valve 1032 At the first power, urine flows through the guide tube 1033 into the main tube 2012 and the volume flow is recorded by the flow assembly 2011. The initial urine flows through the main tube 2012 into the urine storage tank. When the urine circulation time reaches the preparation time, the three-way valve 2013 connected to the sampling tube 2014 and the main tube control valve 2017 open the direction of the sampling tube 2014, the sampling valve 2016 is closed, and the bypass valve of the sampling tube 2014 is open. The state is set so that the middle urine can flow into the sampling tube 2014 and remain in the sampling port 2015. After the sampling time is reached and all the sampling ports 2015 have sufficient urine, the direction of the sampling tube 2014 is first closed with the three-way valve 2013, so that the subsequent urine flows into the urine storage tank 2031 through the main pipe 2012. After a certain period of time, the main pipe control valve 2017 is closed so that only the sampling port 2015 in the sampling tube 2014 retains urine.

[0089] Preferably, the computing unit 301 controls the test paper reagent box conveying component 2021 to convey a number of unused urine test reagent boxes 2026 to the corresponding test position 2022 and hold them, and the computing unit 301 controls the sampling valve 2016 to open, so that the urine in the sampling port 2015 drips onto the urine test reagent box 2026 arranged above the test position 2022 through the middle hole of the protective layer 2023. After the dripping is completed, the sampling valve 2016 is closed, and the reagent box conveying component 2021 is started to transfer the urine test reagent box 2026 to the camera position directly below the camera component 2024. After the reaction time is over, the camera component 2024 captures the image information of the urine test reagent box 2026 and transmits it to the computing unit 301. The computing unit 301 obtains the color change of the urine test reagent box 2026 based on the image recognition and the pre-stored information of the urine test reagent box 2026. The urine test kit 2026 is composed of a number of test kit units of the same size, so that the urine test kit 2026 presents a serial transmission structure under the action of the test kit transmission component 2021. The distance from the test position 2022 to the camera position is an integer multiple of a number of test kit units, and the camera component 2024 is configured with a movable track that can move in the test kit transmission direction. If the previous test kit unit is in the reaction time and the patient has a new round of urination, after the new round of sampling is completed, the camera component 2024 follows the previous test kit unit and moves the length of one test kit unit in the transmission direction. After the previous test kit unit reaches the reaction time and the camera component 2024 collects image information, the camera component 2024 moves the length of one test kit unit in the opposite direction of the transmission direction, so that the camera component 2024 is aligned with the current test kit unit.

[0090] Preferably, the interactive unit 302 displays the image information of the urine test kit 2026 in a sequential manner. Specifically, the information of several urine test kits 2026 is arranged into a scrolling, subtitle-style sequence based on the different test items. The sequence can be arranged horizontally or vertically, and the image information of different kit units in the sequence is annotated with the test time and test result identifier. The test time can be an absolute time or a relative time relative to the start of the procedure; the test result identifier can be in Chinese, English, an image, or a color. The interactive unit 302 also displays the flow information measured by the flow component 2011. The flow information is displayed in the form of a volume flow curve, with the vertical axis representing the volume flow and the horizontal axis representing the test time. The volume flow curve also displays the statistical results of urine excretion for different time periods, such as the previous hour or the previous two hours.

[0091] Preferably, after a single urine sampling is completed or the operation is over, in order to effectively clean the pipes for urine circulation in the sampling unit 201, the computing unit 301 opens the direction of the three-way valve 2013 and the cleaning liquid injection pipe 2046 and closes the direction toward the flow assembly 2011, so that the cleaning liquid can enter the main pipe 2012, opens the sampling valve 2016, opens the direction of the bypass valve of the sampling pipe 2014 connected to the sampling bypass pipe 2042 and closes the direction toward the test position 2022, opens the three-way valve 2013 connected to the sampling pipe 2014, and closes the direction toward the test position 2022. In three directions, the main control valve 2017 is opened, the main bypass valve 2043 is opened in the direction toward the main bypass pipe 2041 and closed in the direction toward the urine storage tank 2031; so that the cleaning liquid in the cleaning liquid storage tank 2032 can flow into the recovery liquid storage tank through the main pipe 2012 and the main bypass pipe 2041, and can also flow into the recovery liquid storage tank through the main pipe 2012, the sampling pipe 2014, the sampling port 2015, and the sampling bypass pipe 2042, so that the cleaning unit 204 can perform closed automatic cleaning on the pipeline of the monitoring module 200.

[0092] Preferably, the system is also provided with a body fluid management unit 305, which obtains body fluid management parameters based on the physiological information of the analysis module 300. The physiological information includes: urine output, urine test results, blood pressure, heart rate, osmotic pressure, patient's preoperative fasting time, patient weight and other parameters. The body fluid management parameters include the total amount of replenishment, replenishment speed, and the ratio of replenishment components.

[0093] Body fluids are an essential component of the internal environment, fundamental to metabolism and organ function, and play roles in temperature regulation, solvents, transportation, and lubrication. Body fluids comprise approximately 60% of body weight and can be divided into two main components: intracellular fluid (intracellular fluid), which accounts for approximately 40% of body weight, and extracellular fluid (extracellular fluid), which exists outside cells. Extracellular fluid is further divided into two categories: interstitial fluid (interstitial fluid), which exists between tissue cells and includes lymph and cerebrospinal fluid, and accounts for approximately 16% of body weight; and plasma (plasma), which accounts for approximately 5% of body weight.

[0094] To ensure the normal volume and parameters of body fluids, the body automatically regulates itself through fluid regulation involving multiple systems. This is manifested in the production of specific chemical substances by certain cells in the body, which, with the help of blood circulation, reach organs and tissues throughout the body or a specific organ and tissue, thereby causing specific reactions in these organs and tissues. The various hormones secreted by many endocrine cells regulate the body's functions through the pathways of fluid circulation. However, in clinical practice, for patients with prolonged perioperative periods and surgeries lasting several hours or even more than ten hours, especially during surgery, the patient's autoregulatory function is blocked or partially blocked. Medical staff need to manage the patient's body fluids according to the patient's physiological parameters to ensure that the patient's various systems are in a normal functional state.

[0095] The transfer of water in the body is affected by the combined effects of hydrostatic pressure and osmotic pressure; the body's automatic regulatory functions include: the kidneys regulate water and electrolyte balance, which plays a role in regulating water and electrolyte balance by diluting and concentrating urine and excreting and reabsorbent various electrolytes; neural regulation, changes in osmotic pressure cause changes in hypothalamic osmotic pressure receptors, prompting water replenishment; endocrine regulation: the hypothalamus, posterior pituitary gland, and antidiuretic hormone system maintain normal osmotic pressure, and the renin, angiotensin, and aldosterone systems maintain normal blood volume.

[0096] Fluid management involves supplemental components, including crystalloids and colloids. Crystalloids and colloids each play an important role in fluid therapy. Crystalloids are primarily used to replace water loss and maintain electrolyte balance, while colloids are primarily used to expand blood volume to maintain effective circulating blood volume. For example, colloids primarily include whole blood, plasma, and dextran. Electrolyte solutions include sodium lactate, normal saline, sodium bicarbonate, and Ringer's solution. Water supplements include 5% and 10% glucose solutions. Nutrient solutions include hydrolyzed protein, fat emulsions, and human albumin. Various antibiotics and hormones are also available.

[0097] Preferably, the total amount of replenishment can be divided into physiological maintenance amount, trauma replenishment amount, urination replenishment amount and balance replenishment amount; the first replenishment rate of the physiological maintenance amount remains basically unchanged during the operation, and is mainly used to balance the amount of fluid lost by the patient's skin, respiration, etc.; the second replenishment rate of the trauma replenishment amount is adjusted according to the operation specifications to balance the amount of body fluid lost in the surgical area; the third replenishment rate of the urination replenishment amount is determined according to the urine output; the fourth replenishment rate of the balance replenishment amount is determined by the patient's physiological indicators, such as blood pressure, heart rate, osmotic pressure, etc., to balance the first three replenishment methods, so that the patient can maintain stable physiological indicators; the total replenishment rate is the superposition of the first to fourth replenishment rates; the ratio of replenishment components is mainly the ratio of crystalloid fluid and colloid fluid. When the patient's body osmotic pressure is high and he is relatively lacking in water, the replenishment ratio of crystalloid fluid can be appropriately increased. When the patient's blood volume decreases, the replenishment ratio of colloid fluid can be appropriately increased.

[0098] Preferably, the amount of urine discharged can directly affect the amount of water in the patient's body. After the patient urinates, a urine supplement of a volume similar to the urine discharge volume needs to be supplemented, and the injection speed can be divided into several levels. For example, a certain proportion of the total amount is supplemented in several time stages after urination, such as 1 / 2 of the total amount is supplemented in the first time period, 1 / 3 in the second time period, and 1 / 6 in the third time period. The length of each time period can be set in a manner that the third supplement speed decreases from the first time period to the third time period. Specifically, when the patient's single urine volume is 600 ml and the previous discharge supplement has been injected, The urine replenishment volume can be set to 600ml, and the injection time can be adjusted according to the patient's physiological state. For example, the first time period is set to 20min and the replenishment volume is 300ml, then the third replenishment speed of the first time period is 15ml / min, the second time period is set to 10min, and the replenishment volume is 200ml, then the third replenishment speed of the second time period is 20ml / min, the third time period is set to 10min, and the replenishment volume is 100ml, then the third replenishment speed of the third time period is 10ml / min, so that the third replenishment speed and replenishment time can be adjusted according to the urine output and the patient's state.

[0099] Preferably, the fourth replenishment rate is determined mainly based on the patient's urine test results, blood pressure, heart rate, osmotic pressure, patient fasting time, patient weight and other parameters. When the blood pressure drops and the heart rate rises, it means that the patient's blood volume has decreased. The difference between the current blood pressure and heart rate and the average value of the preoperative state is obtained, so that the fourth replenishment rate is positively correlated with the absolute value of the difference; the patient's preoperative fasting time and patient weight can be used to determine the amount of fluid loss before surgery, and after the operation begins, fluid is replenished by adjusting the fourth replenishment rate of the balanced replenishment amount; the urine test results can be used as the basis for adjusting the proportion of replenishment components. The concentration or dilution of the kidneys can be judged based on the urine osmotic pressure and components, and information on blood osmotic pressure can be obtained, and the proportion of the replenishment fluid components can be adjusted accordingly.

[0100] For example, during surgery, the patient is in a fasting state and relies only on fluid supplementation. The normal daily water intake for an adult is: 300ml of endogenous water, 700ml of water in food, and 1000-1500ml of drinking water. The daily water output is: 1000-1500ml of urine, 500ml of skin, 350ml of respiration, and 150ml of feces. Taking a 60kg adult who fasts for 6 hours as an example, the fluid loss before surgery is 3-5ml / kg / h*60kg*6h=1440ml. This part of the fluid can be replenished in stages after the start of the surgery to maintain the patient's normal body fluid status, for example, 1 / 2 is replenished in the first hour, and 1 / 4 is replenished in the second and third hours respectively. The normal maintenance volume during the operation is 4ml*operation time h*60kg. The fluid loss level due to surgical trauma is 2ml / kg / h for minor surgery, 4ml / kg / h for medium surgery, 6ml / kg / h for major surgery, and can reach 15ml / kg / h for major abdominal surgery.

[0101] It should be noted that the above-described specific embodiments are illustrative only. Those skilled in the art may devise various solutions based on the disclosure of the present invention, and such solutions fall within the scope of the present invention and are intended to be protected by the present invention. Those skilled in the art should understand that the present description and its accompanying drawings are intended to be illustrative only and are not intended to limit the scope of the claims. The scope of protection of the present invention is defined by the claims and their equivalents.

Claims

1. A urine collection and monitoring system, characterized in that: The system includes: A collection module (100) is used to collect urine discharged by a patient, the collection module (100) comprising a surgical pad (101) equipped with a bionic position (1011), the surgical pad (101) further being equipped with an external bladder capable of collecting pre-stored patient urine, wherein the external bladder is capable of selectively providing urine to a downstream side, the provision of urine being implemented based on the patient's urination time and / or detection frequency as a gating instruction; A monitoring module (200) for online monitoring of the patient's urine obtained by the collection module (100); An analysis module (300) controls the patient's infused fluid parameters based on the patient's urine monitoring results; The monitoring module (200) is provided with a detection unit (202) for monitoring urine components or markers in urine. When the detection unit (202) passes the urine detection kit (2026) through a test position (2022) for receiving sampled urine and a camera position for image acquisition, the detection unit (202) obtains the urine detection result based on the marker appearance of the urine detection kit (2026) and transmits it to the analysis module (300) to control the injection state of the contrast fluid pumping structure and / or the body fluid management unit (305).

2. The system according to claim 1, wherein: In the case where the monitoring module (200) is capable of measuring the concentration of an acute kidney injury marker in the patient's urine collected by the collection module (100) in an online monitoring manner, in response to a trigger signal related to a comparison result of the acute kidney injury marker concentration with a number of set thresholds and / or a change rate of the acute kidney injury marker concentration, the analysis module (300) issues an early warning prompt and / or controls the injection state of a contrast agent pumping mechanism.

3. The system according to claim 1, wherein: The analysis module (300) is configured with a calculation unit (301), which obtains body fluid management parameters based on the urine output and urine test results obtained by the monitoring module (200) and combined with the patient's physiological parameters to control the body fluid management unit (305) to perform patient body fluid replenishment management.

4. System according to claim 1, characterized in that The detection unit (202) is provided with a camera assembly (2024) above the camera position for collecting images of the urine detection kit (2026). The camera assembly (2024) is connected to a sliding track capable of moving in the conveying direction of the urine detection kit (2026), so that the camera assembly (2024) can adjust the arrangement position of the camera position in the conveying direction of the urine detection kit (2026) based on the sliding track and change the distance between the camera position and the test position (2022).

5. System according to the preceding claim 1, characterized in that The monitoring module (200) is further configured with a storage unit (203) and a cleaning unit (204); the storage unit (203) includes a urine storage tank (2031) for storing the patient's urine; the cleaning unit (204) is used to automatically perform a closed cleaning process on the pipeline channel of the monitoring module (200); the storage unit (203) is configured with a corresponding cleaning liquid storage tank (2032) and a cleaning liquid recovery tank (2033); wherein at least one of the urine storage tank (2031), the cleaning liquid storage tank (2032) and the cleaning liquid recovery tank (2033) is configured as an integrally replaceable structure.

6. System according to claim 5, characterized in that The monitoring module (200) includes a sampling unit (201) configured with a sampling tube (2014), and the sampling unit (201) performs quantitative sampling of the patient's urine based on a sampling port (2015) connected to the sampling tube (2014), and the sampling port (2015) is configured as a double-opening space that fits the lower edge of the sampling tube (2014).

7. System according to claim 6, characterized in that The main pipe (2012) of the sampling unit (201) is provided with a cleaning liquid injection pipe (2046) at a position close to the flow component (2011); when the main pipe (2012) is provided with a main pipe bypass pipe (2041), the sampling pipe (2014) is provided with a sampling bypass pipe (2042) at a position close to the sampling port (2015); wherein the horizontal pipes in the sampling unit (201) and the cleaning unit (204) are arranged in a manner with an inclination in the flow direction.

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