Urinary catheter external clamping type urine volume monitoring device and method

Abstract

The invention relates to the field of medical apparatus and instruments, in particular to a catheter outer clamping type urine volume monitoring device and method.The catheter outer clamping type urine volume monitoring device comprises a clamping body module capable of being controlled to be opened and closed and used for detachably wrapping the outer wall of a catheter; the sensing module is integrated on the inner surface of the clamping main body module and comprises a flow velocity detection unit used for acquiring a urine flow velocity signal based on an ultrasonic time-difference method; the deformation detection unit is used for acquiring peripheral deformation distribution of the urinary catheter through contact type pressure sensing; the parameter calibration module comprises a non-contact optical measurement assembly and is used for acquiring geometric parameters of the ureter before and after the clamping operation; the control module is in communication connection with the sensing module and the parameter calibration module and is used for dynamically adjusting the clamping pressure according to the geometric parameters; and fusing the flow velocity signal and the deformation distribution data to generate a calibrated urine flow value. According to the invention, high-precision and multi-dimensional urine volume monitoring is realized, and the system adapts to a complex flowing state.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to an external clip type urine volume monitoring device and method for urinary catheters. Background Art

[0002] Urine volume monitoring is an important indicator in clinical nursing and intensive care. Its accuracy and real-time nature are of great significance for the assessment of the patient's condition, adjustment of treatment plans, and prognosis judgment. Traditional urine volume monitoring methods mainly rely on manual weighing or measuring the volume of urine collection bags. Although these methods are simple and easy to implement, they have many limitations: Firstly, the manual weighing method requires frequent operations, increasing the workload of medical staff and making continuous monitoring difficult. Secondly, the method of measuring the volume of urine collection bags cannot provide instantaneous urine flow data and can only reflect the cumulative urine volume over a period of time, unable to meet the real-time monitoring requirements for dynamic urine flow changes.

[0003] In recent years, with the development of medical device technology, sensor-based urine volume monitoring devices have gradually been introduced into clinical practice. However, there are still some technical problems to be solved urgently in the existing urine volume monitoring devices. For example, some devices adopt an invasive design and detect the flow rate by directly inserting into the urinary catheter. This method not only easily causes urinary tract infections but may also damage the structure of the urinary catheter due to long-term use, affecting the safety and comfort of patients. In addition, non-invasive urine volume monitoring devices usually rely only on a single sensing method (such as ultrasonic detection or pressure sensing), making it difficult to comprehensively capture changes in the urine flow state. Especially when the material, diameter, or shape of the urinary catheter changes, their measurement accuracy is often significantly affected.

[0004] In practical applications, the geometric parameters (such as outer diameter, wall thickness) and material properties (such as elastic modulus, Poisson's ratio) of urinary catheters may vary due to different brands and models, and even creep phenomena may occur on the same urinary catheter due to long-term use. This diversity poses additional challenges to non-invasive urine volume monitoring: If the clamping force is too large, it may cause the urinary catheter to deform or even block; if the clamping force is too small, it will affect the coupling effect between the sensor and the urinary catheter, reducing the measurement accuracy. Therefore, how to achieve high-precision and multi-dimensional urine volume monitoring while ensuring safety and stability has become a key problem that needs to be solved urgently.

[0005] In the prior art, the "novel urine volume monitoring device" with the patent number CN216907981 uses a urine volume monitoring device based on ultrasonic detection, but its design still has some deficiencies. For example, the adjustment of the clamping force is not precise enough to adapt to urinary catheters of different materials and sizes. In addition, the "urinary catheter with pressure monitoring device" with the patent number CN211935122 has a certain pressure monitoring function, but it mainly focuses on the balloon pressure monitoring of the urinary catheter rather than urine volume monitoring, and it cannot achieve dynamic monitoring of urine flow rate and urinary catheter deformation.

[0006] To solve the above problems, this application proposes an external clamping type urine volume monitoring device for urinary catheters and its method. Summary of the Invention

[0007] The purpose of the present invention is to provide an external clamping type urine volume monitoring device for urinary catheters and its method to solve the problems of low safety, poor stability, insufficient accuracy and inability to adapt to complex flow states in the existing urine volume monitoring technology.

[0008] To achieve the above purpose, the following technical solutions are adopted.

[0009] An external clamping type urine volume monitoring device for urinary catheters includes:

[0010] A clamping main body module that can be controlled to open and close, which is used to detachably cover the outer wall of the urinary catheter;

[0011] A sensing module integrated on the inner surface of the clamping main body module, including:

[0012] A flow rate detection unit, which is used to obtain urine flow rate signals based on the ultrasonic time difference method;

[0013] A deformation detection unit, which is used to obtain the circumferential deformation distribution of the urinary catheter through contact pressure sensing;

[0014] A parameter calibration module, which includes a non-contact optical measurement component and is used to obtain the geometric parameters of the urinary catheter before and after the clamping operation;

[0015] A control module, which is communicatively connected to the sensing module and the parameter calibration module, and is used to dynamically adjust the clamping pressure according to the geometric parameters; fuse the flow rate signal and the deformation distribution data to generate a calibrated urine flow value.

[0016] Optionally, the parameter calibration module includes a laser scanning unit and an image processing unit. The laser scanning unit is used to emit a circular laser beam to scan the outer surface of the urinary catheter before clamping, and the image processing unit is used to calculate the geometric parameters of the urinary catheter based on Moiré fringe analysis.

[0017] Optionally, the laser scanning unit includes a wavelength-tunable VCSEL array for adaptively selecting the optimal operating wavelength according to the material of the urinary catheter.

[0018] Optionally, the clamping body module includes a shape memory alloy actuation layer and an elastic reset layer, and the phase change temperature range of the shape memory alloy actuation layer is close to the human body surface temperature.

[0019] Optionally, the control module is integrated with a dynamic compensation algorithm library, and the algorithm library includes differential processing models for steady flow, pulsatile flow, and intermittent flow.

[0020] An external clamping type urine volume monitoring method for a urinary catheter includes the following steps:

[0021] S1. Use the laser scanning unit of the parameter calibration module to perform a circular laser scan on the outer surface of the urinary catheter to obtain three-dimensional topography data of the outer wall of the urinary catheter; combine the pre-stored material property database to calculate the initial clamping parameter set, and the initial clamping parameter set includes the clamping force range and the deformation threshold;

[0022] S2. According to the initial clamping parameter set obtained in S1, apply a pre-tightening force through the shape memory alloy actuation layer of the clamping structure; use the deformation detection unit to collect the circumferential deformation data of the urinary catheter in real time, and when the deformation data meets the preset stability condition, output a stable clamping signal;

[0023] S3. After receiving the stable clamping signal output in S2, use the flow rate detection unit to synchronously collect the urine flow rate signal, and at the same time collect the circumferential strain gradient data of the urinary catheter through the deformation detection unit;

[0024] S4. Input the flow rate signal and the strain gradient data collected in S3 into the dynamic compensation algorithm library of the control module to generate a real-time calibration coefficient;

[0025] S5. Based on the real-time calibration coefficient obtained in S4, correct the collected original flow rate signal, and calculate the calibrated instantaneous urine flow rate and the cumulative urine volume value;

[0026] S6. Periodically compare the cumulative urine volume value calculated in S5 with the weighing reference value measured by the independent weighing sensor. If the deviation of the comparison result exceeds the set threshold, trigger step S1 to re-perform parameter calibration.

[0027] Optionally, step S1 specifically includes:

[0028] S11. Use the laser scanning unit to emit a circular laser beam to scan the outer surface of the urinary catheter to obtain an interference fringe image of the outer surface of the urinary catheter;

[0029] S12. Based on the interference fringe image, calculate the original outer diameter of the urinary catheter through Moiré fringe analysis;

[0030] S13. Query the matching elastic modulus and Poisson's ratio from the pre-stored material property database according to the material information of the urinary catheter;

[0031] S14. Combine the elastic modulus, Poisson's ratio and material creep characteristics of the urinary catheter to estimate the maximum allowable deformation of the urinary catheter;

[0032] S15. Generate an initial clamping parameter set including the clamping force range and deformation threshold according to the original outer diameter, elastic modulus, Poisson's ratio and maximum allowable deformation of the urinary catheter.

[0033] Optionally, step S2 specifically includes:

[0034] S21. Call the clamping force range in the initial clamping parameter set generated in step S1, and apply a pre-tightening force through the shape memory alloy actuator layer;

[0035] S22. Use the deformation detection unit to collect the pressure distribution data on the circumference of the urinary catheter in real time;

[0036] S23. Calculate the pressure uniformity index according to the collected pressure distribution data, and dynamically adjust the clamping force through the control module to make the clamping force evenly distributed in the circumferential direction of the urinary catheter;

[0037] S24. When the collected deformation data exceeds the deformation threshold set in step S1, trigger the pressure relief protection mechanism of the control module to reduce the clamping force to a safe range;

[0038] S25. When the deformation data remains stable under the preset stability conditions, output a stable clamping signal to step S3.

[0039] Optionally, step S4 specifically includes:

[0040] S41. Perform spectral analysis on the flow velocity signal collected in step S3 to extract the spectral characteristics of the flow velocity signal; at the same time, process the collected strain gradient data to obtain the spatial distribution characteristics of the strain gradient;

[0041] S42. Combine the extracted spectral characteristics of the flow velocity signal and the spatial distribution characteristics of the strain gradient into a feature vector, and input it into the time series neural network of the control module to generate a calibration coefficient;

[0042] S43. Use the calibration coefficient generated in step S42 to dynamically correct the original flow velocity signal collected in step S3 to obtain a calibrated flow velocity signal;

[0043] S44. When the confidence level of the calibration coefficient evaluated by the time series neural network is lower than the set threshold, trigger the abnormal alarm mechanism.

[0044] Optionally, step S6 specifically includes:

[0045] S61. During the urine volume monitoring process, periodically compare the cumulative urine volume value calculated in step S5 with the weighing reference value measured by the independent weighing sensor;

[0046] S62. If the deviation of the comparison result exceeds the set threshold, it is determined that there may be an error in the monitoring device or the urethral catheter parameters have changed, and step S1 is triggered to re - calibrate the parameters and update the material parameters;

[0047] S63. Encrypt the deviation data of the comparison result and upload it to the cloud database through the wireless communication module for storage and analysis;

[0048] S64. Generate a calibration report based on the comparison result and the re - calibrated information, and push it to the terminal device of the medical staff through the wireless communication module.

[0049] Compared with the prior art, the present invention has the following beneficial effects:

[0050] The externally - clamped urine volume monitoring device for urethral catheters proposed by the present invention integrates the sensing module on the outer wall of the urethral catheter through a controllable clamping main body module, avoiding the infection risk and mechanical damage problems that may be caused by invasive designs. At the same time, the parameter calibration module embedded in the device can use a non - contact optical measurement component to obtain the geometric parameters of the urethral catheter, and dynamically adjust the clamping pressure in combination with the control module, so as to ensure that the clamping process will neither cause deformation of the urethral catheter due to excessive pressure nor affect the sensing performance due to insufficient pressure. In addition, by fusing the flow rate signal and the deformation distribution data to generate a calibrated urine flow value, the measurement accuracy is significantly improved, especially suitable for urine volume monitoring of urethral catheters with different materials, specifications and under complex flow conditions. Compared with the prior art, the present device has made breakthrough progress in terms of safety, stability and accuracy.

[0051] The present invention enhances the flexibility and accuracy of the geometric parameter calibration of the urethral catheter. The laser scanning unit and the image processing unit in the parameter calibration module can scan the outer surface of the urethral catheter through a ring - shaped laser beam and analyze the Moiré fringes to quickly obtain the three - dimensional topography data of the urethral catheter. In particular, the wavelength - tunable VCSEL array can adaptively select the best working wavelength according to the material of the urethral catheter, further improving the reliability of the calibration result. The device can adapt to various types of urethral catheters, automatically complete the initial calibration without manual input of parameters, greatly simplifying the operation process.

[0052] The present invention optimizes the mechanical properties of the clamping body module. The clamping body module adopts a composite structure of a shape memory alloy actuation layer and an elastic reset layer, and its phase change temperature range is close to the human body surface temperature, enabling it to remain soft under low-temperature conditions and recover rigidity in the body temperature environment, thereby achieving a stable clamping effect. This design not only reduces the risk of mechanical damage to the urinary catheter but also improves the durability and adaptability of the device in actual use.

[0053] The present invention enhances the intelligent level of urine flow calculation. The dynamic compensation algorithm library integrated in the control module includes differential processing models for steady flow, pulsatile flow, and intermittent flow, and can generate calibration coefficients based on the real-time collected data to effectively cope with various complex urine flow states. This intelligent processing mechanism significantly improves the robustness and application range of the device.

[0054] The present invention improves the full-process closed-loop management of the urine volume monitoring method. From the initial calibration of the geometric parameters of the urinary catheter to the dynamic adjustment of the clamping force, and then to the real-time calibration and abnormal alarm of the urine flow, this method forms a complete closed-loop management system. In particular, the function of periodically comparing and calibrating the cumulative value with the weighing reference value can timely detect system errors and trigger parameter updates to ensure the stability of long-term use. At the same time, the design of encrypting and uploading abnormal data to the cloud database provides support for subsequent data analysis and quality improvement. Brief Description of the Drawings

[0055] Figure 1 is a schematic diagram of the modules according to an embodiment of an external clamping type urine volume monitoring device of the present invention.

[0056] Figure 2 is a schematic diagram of the step flow according to an embodiment of an external clamping type urine volume monitoring method of the present invention. Detailed Embodiments

[0057] The present invention will be described in detail below with reference to the drawings and in conjunction with the embodiments. It should be noted that, without conflict, the embodiments in the present application and the features in the embodiments can be combined with each other.

[0058] The following detailed descriptions are all exemplary descriptions, aiming to provide further detailed descriptions of the present invention. Unless otherwise specified, all technical terms adopted by the present invention have the same meaning as commonly understood by those of ordinary skill in the art to which the present application belongs. The terms used in the present invention are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present invention.

[0059] Embodiment 1

[0060] As Figure 1As shown in the figure, the present invention relates to an external clip - type urine volume monitoring device for urinary catheters, which includes a clamping main body module with controllable opening and closing, a sensing module, a parameter calibration module, and a control module. The clamping main body module is used to detachably wrap around the outer wall of the urinary catheter. It is designed to adapt to urinary catheters of different diameters and materials, and at the same time ensure that no damage is caused to the urinary catheter or the normal flow of urine is affected during the clamping process.

[0061] The clamping main body module is made of flexible material and has a structure with controllable opening and closing, which is convenient for installation and disassembly. Its inner surface is designed with anti - slip textures to ensure close fit with the urinary catheter, and at the same time avoid deformation or blockage of the urinary catheter caused by excessive clamping. Adjustable fixing devices, such as elastic straps or Velcro, are provided on both sides of the clamping main body module to adjust the clamping force according to the diameter of the urinary catheter, ensuring that the device is stably fixed on the outer wall of the urinary catheter during use. A micro - control motor can be installed to control the opening and closing force.

[0062] The sensing module is integrated on the inner surface of the clamping main body module, including a flow velocity detection unit and a deformation detection unit. The flow velocity detection unit uses the ultrasonic time - difference method technology. By setting a pair of ultrasonic transmitting and receiving probes on the outer wall of the urinary catheter, ultrasonic signals are emitted and the time - difference of their propagation in urine is measured. According to the time - difference principle, the flow velocity signal of urine is obtained through calculation. This method has the advantages of non - contact measurement, high precision, and good real - time performance, and can accurately reflect the flow state of urine.

[0063] The deformation detection unit is realized through contact - type pressure sensing technology. A plurality of pressure sensors are evenly distributed on the inner surface of the clamping main body module to monitor the circumferential deformation distribution of the urinary catheter in real time. When urine flows, the urinary catheter will undergo a small circumferential deformation, and the pressure sensors can detect this deformation and convert it into an electrical signal for output. By analyzing the deformation distribution data, the influence of urine flow on the urinary catheter can be further understood, providing auxiliary data for the accurate calculation of urine flow rate.

[0064] The parameter calibration module includes a non - contact optical measurement component, which is used to obtain the geometric parameters of the urinary catheter before and after the clamping operation. This component includes a micro - laser emitter and an image sensor. Before clamping, the laser emitter emits a circular laser beam to the outer surface of the urinary catheter, and the image sensor captures the laser reflection image on the surface of the urinary catheter. By analyzing the image and combining the Moiré fringe technology, geometric parameters such as the outer diameter and wall thickness of the urinary catheter can be accurately calculated. These parameters are crucial for subsequent processing of flow velocity and deformation data and can provide an accurate benchmark for the calibration of urine flow rate.

[0065] After the clamping operation is completed, the parameter calibration module performs optical measurements again to confirm the geometric changes of the urinary catheter in the clamped state. By comparing the geometric parameters before and after clamping, the control module can dynamically adjust the clamping pressure to ensure that the clamping force is appropriate, neither damaging the urinary catheter nor affecting the normal flow of urine.

[0066] The control module is communicatively connected to the sensing module and the parameter calibration module. Its core function is to dynamically adjust the clamping pressure according to the obtained geometric parameters of the urinary catheter, and fuse the flow rate signal and the deformation distribution data to generate a calibrated urine flow value. The control module is built-in with a high-performance microprocessor and a dedicated algorithm, and can process the data from the sensing module and the parameter calibration module in real time.

[0067] First, the control module calculates the clamping pressure range suitable for the current urinary catheter according to the geometric parameters of the urinary catheter obtained by the parameter calibration module, in combination with the preset material property database. By adjusting the actuating device (such as a shape memory alloy actuating layer or a micro motor) in the clamping main body module, the control module can accurately apply and maintain the required clamping pressure.

[0068] Second, the control module performs fusion processing on the urine flow rate signal obtained by the flow rate detection unit and the circumferential deformation distribution data of the urinary catheter obtained by the deformation detection unit. Through a dedicated algorithm, the flow rate signal is calibrated, and at the same time, the urine flow is corrected in combination with the deformation data, and finally an accurate urine flow value is generated. This urine flow value not only reflects the actual flow rate of urine, but also takes into account the deformation influence of the urinary catheter during the clamping process, thereby improving the accuracy and reliability of the monitoring results.

[0069] Through the collaborative work of the above-mentioned modules, the external clamping urine volume monitoring device of the present invention can achieve high-precision, real-time, and continuous monitoring of urine volume, while ensuring friendliness to the urinary catheter and patients. The device has a simple structure and convenient operation, is applicable to various medical environments, can provide reliable urine volume monitoring data for medical staff, helps to timely detect the condition changes of patients, and improves the quality and efficiency of medical care.

[0070] As a preferred example, it further includes an information transmission module for transmitting the monitoring results to a user terminal, and the user terminal can be a monitoring system of medical staff.

[0071] As a preferred example, the laser scanning unit and the image processing unit of the parameter calibration module are used to accurately obtain the geometric parameters of the urinary catheter, and the implementation method is as follows:

[0072] The parameter calibration module includes a laser scanning unit and an image processing unit. The laser scanning unit is used to perform non-contact scanning on the outer surface of the urinary catheter before the clamping operation to obtain the geometric shape information of the urinary catheter. The image processing unit calculates the geometric parameters of the urinary catheter, such as outer diameter, wall thickness, ellipticity, etc., based on the scanning data through Moiré fringe analysis technology, providing accurate reference data for subsequent urine volume monitoring.

[0073] The laser scanning unit includes a micro ring laser emitter that emits a ring laser beam with a specific wavelength (e.g., 650nm). The ring laser beam can evenly irradiate the outer surface of the urinary catheter, forming clear light spots or fringes. The laser emitter is installed on the inner surface or the top of the clamping main body module to ensure that the laser beam can irradiate the surface of the urinary catheter vertically or at a certain angle.

[0074] Before the clamping operation, the laser scanning unit is activated, and the ring laser beam scans along the axial direction of the urinary catheter. During the scanning process, the laser beam forms ring light spots or fringes on the surface of the urinary catheter, and these light spots or fringes will deform accordingly with the change of the geometric shape of the urinary catheter surface. The deformed light spot or fringe images are captured by a high-speed camera or other optical sensors, providing the original data for subsequent image processing.

[0075] The image processing unit receives the image data obtained by the laser scanning unit and analyzes and processes it. Based on Moiré fringe analysis technology, the unit accurately calculates the geometric parameters of the urinary catheter by calculating the displacement, deformation, and spacing change of the light spots or fringes in the image.

[0076] Moiré fringe analysis is a high-precision optical measurement technology, and its principle is to utilize the interference phenomenon of light. When the ring laser beam irradiates the surface of the urinary catheter, the geometric shape of the urinary catheter (such as outer diameter, ellipticity, etc.) will cause the deformation of the light spots or fringes. The image processing unit calculates the geometric parameters such as the outer diameter, wall thickness, and ellipticity of the urinary catheter by analyzing these deformed fringes and combining the known laser wavelength and scanning angle.

[0077] In specific implementation, the image processing unit includes the following steps:

[0078] Use a high-resolution camera to capture the light spot or fringe image formed by the ring laser beam on the surface of the urinary catheter.

[0079] Perform preprocessing operations such as denoising and contrast enhancement on the collected images to improve the image quality.

[0080] Extract the contour information of the light spots or fringes through an edge detection algorithm.

[0081] Based on the extracted fringe contour, calculate the displacement and deformation amount of the fringes. Through an optical geometric model, convert the deformation amount of the fringes into the geometric parameters of the urinary catheter.

[0082] Finally, geometric parameters such as the outer diameter, wall thickness, and ovality of the urinary catheter are calculated and stored in the database of the control module for subsequent urine volume monitoring and clamping pressure adjustment.

[0083] Through the collaborative work of the above-mentioned laser scanning unit and image processing unit, the present invention can accurately obtain the geometric parameters of the urinary catheter, providing high-precision initial calibration data for the urine volume monitoring device. This non-contact measurement method not only avoids physical contact damage to the urinary catheter but also can quickly adapt to urinary catheters of different specifications and materials in different usage scenarios, improving the versatility and reliability of the urine volume monitoring device.

[0084] As a specific example, in the present invention, the laser scanning unit includes a wavelength-tunable VCSEL (Vertical-Cavity Surface-Emitting Laser) array, which is used to adaptively select the best working wavelength according to the material of the urinary catheter. The specific implementation method is as follows:

[0085] The core component of the laser scanning unit is a wavelength-tunable VCSEL array. VCSEL is a semiconductor laser with the advantages of small size, low power consumption, high beam quality, and easy integration. The array consists of multiple independently addressable VCSELs, and each VCSEL can independently control its emission state and wavelength, thereby achieving the best adaptability to urinary catheters of different materials.

[0086] The wavelength tuning function of the VCSEL array is based on the characteristics of its semiconductor material, and the emission wavelength of the laser is adjusted by changing the injection current or temperature. In the present invention, the wavelength range of the VCSEL array covers the near-infrared to visible light region (for example, 785nm to 1060nm), which can meet the requirements of different urinary catheter materials (such as silicone, polyvinyl chloride, etc.) for laser absorption and reflection characteristics.

[0087] In practical applications, the material of the urinary catheter affects the reflectivity and penetration depth of the laser. For example, silicone urinary catheters have a relatively high reflectivity to certain wavelengths of laser, while polyvinyl chloride urinary catheters may require different wavelengths of laser to obtain the best scanning effect. Therefore, the VCSEL array can adaptively adjust the emission wavelength according to the material of the urinary catheter to ensure that the laser scanning unit can obtain high-quality image data.

[0088] During specific implementation, the device first determines the material type of the urinary catheter through a preset database or user input. According to the material type, the control module calculates and sets the best working wavelength of the VCSEL array. For example, for a silicone urinary catheter, the VCSEL array may select a wavelength of 840nm for scanning; for a polyvinyl chloride urinary catheter, a wavelength of 930nm may be selected.

[0089] During the scanning process, the VCSEL array emits a ring-shaped laser beam, which uniformly irradiates the outer surface of the urinary catheter. The ring-shaped laser beam forms light spots or stripes on the surface of the urinary catheter, and these light spots or stripes will produce corresponding deformations as the geometric shape of the urinary catheter surface changes. The deformed light spot or stripe images are captured by a high-speed camera or other optical sensors, providing raw data for subsequent image processing.

[0090] The wavelength tunable function of the VCSEL array not only improves the adaptability and accuracy of scanning, but also reduces the measurement error caused by material differences. By dynamically adjusting the wavelength, the device can maintain stable measurement performance under different conditions, further improving the accuracy of measuring the geometric parameters of the urinary catheter.

[0091] By adopting a wavelength tunable VCSEL array, the present invention realizes the selection of the optimal scanning wavelength for urinary catheters of different materials, improves the adaptability and measurement accuracy of the laser scanning unit, and provides an important guarantee for the efficient operation of the external clip type urine volume monitoring device for urinary catheters.

[0092] As a specific example, in the external clip type urine volume monitoring device for urinary catheters described in the present invention, the clamping structure includes a shape memory alloy actuating layer and an elastic reset layer, and its implementation manner is as follows:

[0093] The shape memory alloy actuating layer is made of a material with a specific phase change temperature range, and its phase change temperature range is close to the human body surface temperature (for example, 30°C to 40°C), so that phase change drive can be realized within the normal body temperature range of the human body. This actuating layer is made of a shape memory alloy (such as Ni-Ti based alloy), and has the characteristics of martensitic phase transformation and inverse martensitic phase transformation at a specific temperature, and can produce reversible shape changes when heated or cooled.

[0094] In this embodiment, the shape memory alloy actuating layer is driven by Joule heat, that is, phase change is achieved by current heating, so as to generate the required clamping force. This actuating layer is designed as a thin sheet or filamentous structure, embedded in the inner surface or side surface of the clamping main body module, to ensure uniform clamping force on the outer wall of the urinary catheter. When current passes through the shape memory alloy, its temperature rises above the phase change temperature, and the alloy changes from the martensitic phase to the austenitic phase, generating a contraction force, thereby realizing the clamping of the urinary catheter.

[0095] The elastic reset layer works together with the shape memory alloy actuating layer to restore the initial state of the clamping main body module when the clamping force is released. The elastic reset layer is made of a high-elastic material (such as polyimide, polyvinyl chloride, etc.), and has good elasticity and durability. This layer is designed as a thin sheet structure, located outside the shape memory alloy actuating layer or on the inner surface of the clamping main body module, and can make the clamping main body module return to the initial open state through its elastic restoring force after the shape memory alloy actuating layer cools down.

[0096] Specifically, the elastic properties of the elastic reset layer can compensate for the relaxation force generated by the shape memory alloy actuator layer during the cooling process, ensuring that the clamping body module can still maintain good clamping performance after multiple uses. In addition, the material selection of the elastic reset layer needs to consider the thermal expansion coefficient matching with the shape memory alloy actuator layer to reduce stress concentration caused by temperature changes.

[0097] In actual use, when it is necessary to clamp the urinary catheter, the control module applies an electric current to the shape memory alloy actuator layer, causing its temperature to rise above the phase transition temperature, thereby generating a contraction force to clamp the urinary catheter. At this time, the elastic reset layer is compressed and stores elastic potential energy. When it is necessary to release the clamping force, the control module cuts off the current, the shape memory alloy actuator layer cools and returns to the martensite phase, and the elastic reset layer pulls the clamping body module back to the initial state through its elastic restoring force.

[0098] Through the synergistic effect of the shape memory alloy actuator layer and the elastic reset layer, the clamping structure of the present invention can achieve efficient and stable clamping and releasing functions within the human body temperature range, while avoiding excessive compression of the urinary catheter and ensuring the smooth flow of urine.

[0099] The present invention realizes precise clamping and releasing of the urinary catheter by adopting a combined design of a shape memory alloy actuator layer and an elastic reset layer, while ensuring the reliability and durability of the clamping structure, providing an important guarantee for the efficient operation of the urine volume monitoring device.

[0100] As a preferred example, in the external urinary catheter clamping type urine volume monitoring device of the present invention, the control module is integrated with a dynamic compensation algorithm library for differential processing of different urine flow states (steady flow, pulsatile flow, and intermittent flow), and its specific implementation method is as follows:

[0101] The dynamic compensation algorithm library is the core component of the control module. Its purpose is to dynamically adjust the urine flow calculation model by real-time monitoring and analysis of the urine flow state to improve the monitoring accuracy. The algorithm library contains differential processing models for different flow states, specifically as follows:

[0102] Steady flow refers to the state where urine flows at a constant speed. In this case, the calculation of urine flow mainly depends on the flow velocity signal provided by the flow velocity detection unit. The algorithm model performs spectral analysis on the flow velocity signal through Fourier transform, extracts its fundamental frequency component, thereby obtaining a stable flow velocity value. At the same time, combined with the geometric parameters of the urinary catheter (such as inner diameter), the urine flow is calculated. This model is suitable for scenarios where urine flow is stable and can effectively reduce measurement errors.

[0103] Pulsatile flow refers to the periodic fluctuations during urine flow, which are commonly seen in situations where the patient's urine flow is unstable due to physiological activities (such as coughing, body position changes). The pulsatile flow processing model performs short-time Fourier transform (STFT) on the flow rate signal through time series analysis technology to extract the time-frequency characteristics of the signal. The algorithm dynamically adjusts the flow rate calculation formula according to the pulsation frequency and amplitude, and combines the urethral catheter deformation data provided by the deformation detection unit to compensate and correct the urine flow rate. This model can effectively handle the periodic changes in urine flow and ensure the accuracy of the measurement results.

[0104] Intermittent flow refers to the situation where there are intermittent interruptions during urine flow. For example, the patient's urine flow is intermittent due to bladder spasm or catheter blockage. The intermittent flow processing model uses the hidden Markov model (HMM) to classify the states of the flow rate signal. The algorithm classifies the urine flow states into two types: "flowing" and "interrupted", and dynamically adjusts the calculation of urine flow according to the state transition probability. In the flowing state, the algorithm calculates the urine flow by combining the flow rate signal and deformation data; in the interrupted state, the algorithm estimates the urine flow during the interruption through historical data and trend prediction. This model can effectively handle the intermittent changes in urine flow and improve the continuity and reliability of monitoring.

[0105] In practical applications, the control module first obtains the urine flow rate signal and urethral catheter deformation data through the flow rate detection unit and the deformation detection unit. Then, the algorithm library determines the current urine flow state (steady flow, pulsatile flow or intermittent flow) according to the characteristics of the flow rate signal (such as frequency, amplitude, periodicity), and selects the corresponding processing model for calculation.

[0106] The specific steps are as follows:

[0107] Perform filtering processing on the flow rate signal to remove noise interference and extract the effective signal components.

[0108] Identify the current urine flow state through time series analysis and spectrum analysis. For example, detect the periodic changes of the signal through short-time Fourier transform to determine whether it is pulsatile flow.

[0109] Select the corresponding processing model according to the identified flow state. For steady flow, directly calculate the flow rate and urine flow; for pulsatile flow, perform compensation and correction by combining time-frequency characteristics; for intermittent flow, estimate and compensate through state transition probability.

[0110] Output the calculated urine flow rate value to the display module or the data storage module, and dynamically adjust the algorithm model according to the actual measurement results to optimize the accuracy of subsequent measurements.

[0111] Through the design and implementation of the above dynamic compensation algorithm library, the present invention can accurately process different urine flow states, significantly improving the accuracy and reliability of urine volume monitoring. This technical solution is not only applicable to various complex clinical scenarios, but also can adapt to the physiological changes of patients in real time, providing reliable monitoring data support for medical care.

[0112] Example 2

[0113] As Figure 2 shown, the specific implementation steps of the external clip type urine volume monitoring method for urinary catheter of the present invention are as follows:

[0114] S1. Use the laser scanning unit of the parameter calibration module to perform circular laser scanning on the outer surface of the urinary catheter to obtain three-dimensional topography data of the outer wall of the urinary catheter; combine with the pre-stored material property database to calculate the initial clamping parameter set, and the initial clamping parameter set includes the clamping force range and the deformation threshold

[0115] Before the urine volume monitoring starts, first start the parameter calibration module of the device. The laser scanning unit emits a circular laser beam to the outer surface of the urinary catheter, and the laser beam forms interference fringes on the surface of the urinary catheter. These fringes are captured by a high-precision image sensor to obtain three-dimensional topography data of the outer wall of the urinary catheter. The image processing unit preprocesses the captured image, including operations such as denoising, filtering, and fringe extraction, and then calculates geometric parameters such as the original outer diameter and wall thickness of the urinary catheter based on the Moiré fringe analysis technology.

[0116] According to the material information of the urinary catheter (such as silicone, polyvinyl chloride, etc.), query the matching elastic modulus and Poisson's ratio from the pre-stored material property database. Combine the geometric parameters of the urinary catheter and the creep characteristics of the material to deduce the maximum allowable deformation amount of the urinary catheter during the clamping process. Finally, generate an initial clamping parameter set, which includes the clamping force range and the deformation threshold, to guide the subsequent clamping operation.

[0117] S2. According to the initial clamping parameter set obtained in S1, apply a pre-tightening force through the shape memory alloy actuator layer of the clamping structure; use the deformation detection unit to collect the circumferential deformation data of the urinary catheter in real time, and when the deformation data meets the preset stability condition, output a stable clamping signal

[0118] The control module applies a pre-tightening force through the shape memory alloy actuator layer in the clamping structure according to the initial clamping parameter set generated in step S1. The shape memory alloy actuator layer realizes phase change drive through current heating to generate the required clamping force. During the clamping process, the deformation detection unit collects the pressure distribution data of the circumference of the urinary catheter in real time to monitor the deformation of the urinary catheter.

[0119] The control module analyzes the collected deformation data, calculates the pressure uniformity index, and dynamically adjusts the clamping force to ensure that the clamping force is evenly distributed in the circumferential direction of the urinary catheter. When the deformation data meets the preset stability conditions (i.e., the amount of deformation is within the set threshold range and remains stable), the control module outputs a stable clamping signal, indicating that the urinary catheter has been safely and stably clamped, and the device can enter the next urine flow monitoring stage.

[0120] S3. After receiving the stable clamping signal output by S2, the flow rate detection unit synchronously collects urine flow rate signals, and at the same time, the circumferential strain gradient data of the urinary catheter is collected through the deformation detection unit

[0121] After receiving the stable clamping signal output in step S2, the flow rate detection unit starts to measure the urine flow rate by the ultrasonic time difference method. The ultrasonic transmitting probe and the receiving probe are respectively installed at symmetric positions on the outer wall of the urinary catheter. By measuring the time difference of the ultrasonic wave propagation in the urine, the urine flow rate signal is calculated. At the same time, the deformation detection unit continues to monitor the circumferential strain gradient data of the urinary catheter to provide auxiliary information for subsequent urine flow calibration.

[0122] S4. Input the flow rate signal and strain gradient data collected in S3 into the dynamic compensation algorithm library of the control module to generate a real-time calibration coefficient

[0123] The control module inputs the flow rate signal and strain gradient data collected in step S3 into the dynamic compensation algorithm library. The algorithm library selects the corresponding processing model according to the urine flow state (such as steady flow, pulsatile flow or intermittent flow). For example, for pulsatile flow, the algorithm extracts the spectral characteristics of the flow rate signal through time series analysis and generates a calibration coefficient in combination with the strain gradient data. This calibration coefficient is used to correct the measurement error caused by the deformation of the urinary catheter or the uneven urine flow.

[0124] S5. Based on the real-time calibration coefficient obtained in S4, correct the collected original flow rate signal, and calculate the calibrated instantaneous urine flow rate and cumulative urine volume value

[0125] The control module dynamically corrects the original flow rate signal collected by the flow rate detection unit according to the real-time calibration coefficient generated in step S4. The instantaneous urine flow rate is calculated through the corrected flow rate signal, and the cumulative urine volume value is obtained by integrating the instantaneous urine flow rate. The calibrated urine flow rate value can more accurately reflect the actual urine flow situation and reduce the deviation caused by measurement error or urinary catheter deformation.

[0126] S6. Periodically compare the cumulative urine volume value calculated in S5 with the weighing reference value measured by the independent weighing sensor; if the deviation of the comparison result exceeds the set threshold, trigger step S1 to re-perform parameter calibration

[0127] During the urine volume monitoring process, the control module periodically compares the cumulative urine volume value calculated in step S5 with the weighing reference value measured by the independent weighing sensor. The weighing sensor is installed under the urine bag and is used to monitor the weight change of urine in real time. If the deviation of the comparison result exceeds the set threshold (e.g., 5%), the control module determines that there may be an error in the monitoring device or a change in the urethral catheter parameters, and triggers step S1 to re - calibrate the parameters, updating the geometric parameters and clamping parameters of the urethral catheter. This process ensures the accuracy and reliability of the monitoring results, and at the same time provides timely technical support and decision - making basis for medical staff.

[0128] Through the above steps, the present invention can achieve high - precision and dynamic calibration during the urine volume monitoring process, and can adjust in time when abnormalities are detected, ensuring the accuracy and reliability of the monitoring results.

[0129] As a specific example, in the external - clamping urine volume monitoring method for urethral catheters of the present invention, the specific implementation of step S1 is as follows:

[0130] In the initial stage of the urine volume monitoring method, first start the parameter calibration module, and use the laser scanning unit to scan the outer surface of the urethral catheter to obtain the geometric parameters of the urethral catheter, and then generate an initial clamping parameter set. The specific steps are as follows:

[0131] First, start the laser scanning unit in the parameter calibration module. This unit includes a micro - ring laser emitter that emits a ring - shaped laser beam with a specific wavelength, which uniformly irradiates the outer surface of the urethral catheter. The ring - shaped laser beam forms interference fringes on the surface of the urethral catheter. These fringe images are captured by a high - precision image sensor to obtain the interference fringe images of the outer surface of the urethral catheter. The resolution of the image sensor should be no less than 1000×1000 pixels to ensure that the details of the fringes can be clearly captured.

[0132] Subsequently, the obtained interference fringe images are transmitted to the image processing unit. This unit first pre - processes the images, including operations such as denoising, contrast enhancement, and edge detection, to improve the image quality. The pre - processed images are used for subsequent moiré fringe analysis. Through moiré fringe analysis technology, the displacement and spacing change of the fringes are calculated, and then the original outer diameter of the urethral catheter is obtained. Specifically, according to the geometric relationship of the moiré fringes, using the formula:

[0133] D = K×Δx

[0134] where D is the original outer diameter of the urethral catheter, K is the proportionality coefficient determined by the laser wavelength and the scanning angle, and Δx is the displacement of the fringes. The original outer diameter of the urethral catheter is calculated through the above formula, and the accuracy can reach 0.01 mm.

[0135] According to the material information of the urinary catheter (such as silicone, polyvinyl chloride, etc.), query the matching elastic modulus (E) and Poisson's ratio (v) from the pre-stored material property database. The material property database stores the physical property parameters of urinary catheters made of different materials. These parameters are obtained through experimental measurements and stored in tabular form in the storage module of the device. For example, for a silicone urinary catheter, its elastic modulus is approximately 1 MPa and Poisson's ratio is approximately 0.48; for a polyvinyl chloride urinary catheter, the elastic modulus is approximately 3 GPa and Poisson's ratio is approximately 0.35.

[0136] Combining the elastic modulus and Poisson's ratio of the urinary catheter and the creep characteristics of the material, calculate the maximum allowable deformation of the urinary catheter during the clamping process. Creep characteristics reflect the deformation behavior of materials under long-term stress, and a creep model is obtained through fitting experimental data. Based on the creep model, the elastic modulus, and Poisson's ratio of the material, calculate the maximum allowable deformation of the urinary catheter under the clamping force. The specific formula is as follows:

[0137]

[0138] Where ∈ max is the maximum allowable deformation, F max is the maximum allowable clamping force, L is the effective length of the urinary catheter, E is the elastic modulus, and A is the cross-sectional area of the urinary catheter. Calculate the maximum allowable deformation of the urinary catheter through the above formula to ensure that the urinary catheter is not damaged during the clamping process.

[0139] Finally, based on the original outer diameter, elastic modulus, Poisson's ratio, and maximum allowable deformation of the urinary catheter, generate an initial clamping parameter set. The initial clamping parameter set includes the clamping force range and the deformation threshold. The clamping force range is dynamically adjusted according to the material and geometric parameters of the urinary catheter to ensure that the clamping force is appropriate, which can not only stably clamp the urinary catheter but also not damage it. The deformation threshold is set to 90% of the maximum allowable deformation and is used to monitor the deformation of the urinary catheter in real time during the clamping process to ensure the safety and reliability of the clamping operation. The initial clamping parameter set is stored in the control module and used to guide subsequent clamping operations.

[0140] Through the above steps, the present invention can accurately obtain the geometric parameters and material characteristics of the urinary catheter before the start of monitoring and generate a reasonable initial clamping parameter set, providing an important guarantee for the stable operation of the urine volume monitoring device.

[0141] As a specific example, in the urinary catheter external clamping urine volume monitoring method described in the present invention, the specific implementation manner of step S2 is as follows:

[0142] After generating the initial clamping parameter set in step S1, enter step S2, and the specific operation is as follows:

[0143] S21. Invoke the clamping force range in the initial clamping parameter set generated in step S1, and apply a pre-tightening force through the shape memory alloy actuator layer

[0144] The control module invokes the initial clamping parameter set generated in step S1 from the storage unit and obtains the clamping force range therein. This clamping force range is calculated based on the geometric parameters and material properties of the urinary catheter, which can ensure that the clamping force is appropriate, neither causing damage to the urinary catheter nor compromising the clamping stability. Subsequently, the control module sends an instruction to the shape memory alloy actuator layer in the clamping structure. By adjusting the magnitude of the current, the shape memory alloy actuator layer undergoes a phase change to apply a pre-tightening force. The magnitude of the pre-tightening force is dynamically adjusted according to the material and diameter of the urinary catheter to ensure that the clamping force is within the set range.

[0145] S22. Use the deformation detection unit to collect the pressure distribution data on the circumference of the urinary catheter in real time

[0146] While applying the pre-tightening force, the deformation detection unit starts to work. This unit consists of multiple high-precision pressure sensors evenly distributed on the inner surface of the clamping main body module, which can monitor the pressure distribution on the circumference of the urinary catheter in real time. The pressure sensors convert the detected pressure signals into electrical signals and transmit them to the control module. The control module processes the received pressure data in real time to generate a pressure distribution map of the circumference of the urinary catheter for subsequent clamping force adjustment.

[0147] S23. According to the collected pressure distribution data, calculate the pressure uniformity index, and dynamically adjust the clamping force through the control module to make the clamping force evenly distributed on the circumference of the urinary catheter

[0148] The control module analyzes the received pressure distribution data and calculates the pressure uniformity index. The pressure uniformity index is calculated by the following formula:

[0149]

[0150] where P i is the pressure value detected by the i-th pressure sensor, is the average value of the pressures detected by all pressure sensors, and n is the total number of pressure sensors. The uniformity index reflects the degree of uniformity of the clamping force on the circumference of the urinary catheter. The smaller the value, the more uniform the clamping force.

[0151] When the uniformity index exceeds a preset threshold (e.g., 10%), the control module determines that the clamping force distribution is uneven and dynamic adjustment is required. The control module locally adjusts the clamping force according to the pressure distribution data by adjusting the current magnitude of the shape memory alloy actuator layer. For example, when the pressure in a certain part is too high, the control module reduces the current of the actuator layer in that area to decrease the clamping force; conversely, when the pressure in a certain part is too low, it increases the current of the actuator layer in that area to increase the clamping force. Through dynamic adjustment, it is ensured that the clamping force is evenly distributed in the circumferential direction of the urinary catheter.

[0152] S24. When the collected deformation data exceeds the deformation threshold set in step S1, trigger the decompression protection mechanism of the control module to reduce the clamping force to a safe range

[0153] While the deformation detection unit is collecting the pressure distribution data in real time, it also monitors the circumferential deformation of the urinary catheter. When the deformation data exceeds the deformation threshold set in step S1, the control module determines that the urinary catheter may be under excessive clamping force and there is a risk of damage. At this time, the control module immediately triggers the decompression protection mechanism, cuts off the current of the shape memory alloy actuator layer, and quickly reduces the clamping force to a safe range. At the same time, the control module records the abnormal data and issues an alarm to prompt the operator.

[0154] S25. When the deformation data remains stable under the preset stability conditions, output a stable clamping signal to step S3

[0155] During the clamping process, the control module continuously monitors the deformation data of the urinary catheter. When the deformation data remains stable under the preset stability conditions (e.g., the deformation data fluctuation does not exceed the preset threshold within 10 consecutive seconds), the control module determines that the urinary catheter has been clamped safely and stably. At this time, the control module outputs a stable clamping signal, indicating that the clamping operation is completed and the device can enter the next urine flow monitoring stage, i.e., step S3.

[0156] Through the above steps, the present invention can monitor the deformation of the urinary catheter in real time during the clamping process, dynamically adjust the clamping force, and ensure the safety and reliability of the clamping operation. This intelligent clamping method not only avoids damage to the urinary catheter but also provides stable conditions for subsequent urine flow monitoring.

[0157] As a specific example, in the method for monitoring urine volume by external clamping of the urinary catheter described in the present invention, the specific implementation manner of step S4 is as follows:

[0158] After completing step S3, that is, synchronously collecting the urine flow rate signal and the circumferential strain gradient data of the urinary catheter, enter step S4 to process and calibrate the collected data, and the specific operations are as follows:

[0159] Data preprocessing and feature extraction

[0160] First, perform spectral analysis on the urine flow rate signal collected in step S3. The flow rate signal is obtained by the flow rate detection unit using the ultrasonic time difference method, and its original signal is time series data. The control module preprocesses the received flow rate signal, including filtering, denoising, and normalization operations, to eliminate environmental interference and measurement noise. Subsequently, the flow rate signal is transformed from the time domain to the frequency domain through the fast Fourier transform (FFT) to extract its spectral features. The spectral features mainly include the fundamental frequency, harmonic frequencies, and their corresponding amplitudes of the signal, and these features can reflect the stability and periodic changes of urine flow.

[0161] Meanwhile, process the circumferential strain gradient data of the urinary catheter collected in step S3. The strain gradient data is obtained by the deformation detection unit and reflects the deformation degree of each position of the urinary catheter during the clamping process. The control module performs spatial interpolation and smoothing processing on these data to generate a spatial distribution map of the strain gradient. By analyzing the spatial distribution characteristics of the strain gradient, the force conditions at different positions of the urinary catheter can be identified, providing auxiliary information for the calibration of the flow rate signal.

[0162] Feature vector generation and calibration coefficient calculation

[0163] Combine the extracted spectral features of the flow rate signal and the spatial distribution features of the strain gradient into a feature vector. The dimension of the feature vector is determined according to the number of spectral features and strain gradient features. For example, if the spectral features include 5 main frequency components and their amplitudes, and the strain gradient features include the gradient values at 10 spatial positions, then the dimension of the feature vector is 15.

[0164] Input the generated feature vector into a temporal neural network (such as long short-term memory network LSTM or gated recurrent unit GRU) in the control module. The temporal neural network has been pre-trained with a large number of sample data and can capture the dynamic relationship between the urine flow state and the deformation of the urinary catheter. The network outputs the corresponding calibration coefficient according to the input feature vector. The calibration coefficient is used to correct the flow rate measurement error caused by the deformation of the urinary catheter or uneven urine flow, and its value range is set according to the network training results, for example, between 0.8 and 1.2.

[0165] Dynamic correction of the flow rate signal

[0166] Use the calibration coefficient generated in step S42 to dynamically correct the original flow rate signal collected in step S3. The specific correction formula is as follows:

[0167] V 校准 = V 原始 × calibration coefficient

[0168] where, V 校准 is the calibrated flow rate signal, V 原始is the original flow rate signal. By adjusting the calibration coefficient, the measurement deviation caused by the deformation of the urinary catheter or the change of urine flow state (such as pulsatile flow, intermittent flow) can be corrected, so as to obtain a more accurate urine flow rate value.

[0169] Calibration Coefficient Confidence Evaluation and Abnormal Alarm

[0170] While outputting the calibration coefficient, the time series neural network will also evaluate its confidence. The confidence reflects the reliability of the calibration coefficient, which is calculated by the uncertainty estimation module inside the network, and its value ranges from 0 to 1. When the confidence is lower than the set threshold (for example, 0.7), it indicates that there may be abnormalities in the current measurement conditions, such as urinary catheter blockage, abnormal urine flow, or sensor failure.

[0171] At this time, the control module triggers the abnormal alarm mechanism to remind medical staff by means of indicator light flashing, buzzer alarm or vibration motor vibration. At the same time, the control module records the timestamp and relevant parameters of the abnormal data for subsequent analysis and processing. The setting of the abnormal alarm mechanism ensures that abnormalities can be detected and processed in time when the measurement results are unreliable, improving the safety and reliability of the system.

[0172] Through the above steps, the present invention can dynamically correct the urine flow rate signal during urine volume monitoring, ensure the accuracy of the measurement results, and give an alarm in time when abnormalities are detected, providing reliable technical support for medical staff.

[0173] As a specific example, in the external clip type urine volume monitoring method for urinary catheter of the present invention, the specific implementation manner of step S6 is as follows:

[0174] After completing step S5, that is, calculating the calibrated instantaneous urine flow rate and cumulative urine volume value, enter step S6 to verify and calibrate the monitoring results. The specific operations are as follows:

[0175] Periodically compare the cumulative urine volume value with the weighing reference value

[0176] During urine volume monitoring, the control module periodically (for example, every 10 minutes or 30 minutes) compares the cumulative urine volume value calculated in step S5 with the weighing reference value measured by the independent weighing sensor. The weighing sensor is installed under the urine bag to monitor the weight change of urine in real time, and the weighing reference value is obtained through the conversion relationship between weight and urine volume. The comparison process is realized by the following formula:

[0177]

[0178] Among them, the deviation value is used to evaluate the accuracy of the monitoring device. The control module stores the comparison results in the local storage unit for subsequent analysis.

[0179] Determine whether the deviation exceeds the threshold and trigger parameter calibration update

[0180] The control module evaluates the received comparison result. If the deviation exceeds the set threshold (e.g., 5%), it is determined that there may be an error in the monitoring device or the catheter parameters have changed. At this time, the control module triggers step S1 to perform parameter calibration again and update the material parameters. The re-calibration process includes:

[0181] Use the laser scanning unit to re-scan the outer surface of the catheter to obtain the latest three-dimensional topography data.

[0182] Combined with the updated topography data and the material property database, recalculate the geometric parameters (such as outer diameter, wall thickness) and physical properties (such as elastic modulus, Poisson's ratio) of the catheter.

[0183] According to the updated parameters, generate a new set of initial clamping parameters, including the clamping force range and deformation threshold.

[0184] After the re-calibration is completed, the control module stores the updated parameters in the local storage unit and notifies the subsequent steps (S2 - S5) to use the new parameters for monitoring.

[0185] Encryption processing and data upload

[0186] Encrypt the deviation data of the comparison result to ensure the security and privacy during data transmission. The encryption algorithm uses the Advanced Encryption Standard (AES) or RSA encryption algorithm, and the encrypted data is uploaded to the cloud database for storage and analysis through a wireless communication module (such as Wi-Fi or 4G module). The cloud database is used to record the operating status of the monitoring device, deviation data, and re-calibration information for subsequent technical support and data analysis.

[0187] Generate a calibration report and push it to the terminal device

[0188] Based on the comparison result and re-calibration information, the control module generates a detailed calibration report. The calibration report includes the following content:

[0189] The current status of the monitoring device, such as the deviation value and whether re-calibration is triggered.

[0190] The catheter parameters after re-calibration, such as outer diameter, wall thickness, elastic modulus, etc.

[0191] Suggested subsequent operations, such as continuing monitoring, checking the catheter status, etc.

[0192] The calibration report is pushed to the terminal devices of medical staff, such as tablets or smartphones, through a wireless communication module, so that medical staff can timely understand the status of the monitoring device and take corresponding measures. The push methods include but are not limited to SMS notification, application push, or email.

[0193] Through the above steps, the present invention can calibrate the monitoring results in real time during urine volume monitoring to ensure the accuracy of the measurement data. At the same time, through the functions of abnormal alarm and data upload, it provides timely technical support and decision-making basis for medical staff, improving the safety and reliability of urine volume monitoring.

[0194] As is known by common technical knowledge, the present invention can be implemented by other embodiments without departing from its spiritual essence or essential features. Therefore, the above-disclosed embodiments are illustrative in all aspects and not exclusive. All changes within the scope of the present invention or within the scope equivalent to the present invention are encompassed by the present invention.

Claims

1. A urinary catheter external clamp type urine volume monitoring device, characterized in that: include, A clamping body module that can be controlled to open and close, used to detachably cover the outer wall of the urinary catheter; The sensing module is integrated on the inner surface of the clamping body module, and includes: a flow rate detection unit for obtaining urine flow rate signals based on ultrasonic time difference method; a deformation detection unit for obtaining circumferential deformation distribution of the urinary catheter through contact pressure sensing; A parameter calibration module, including a non-contact optical measurement component, used to obtain the geometric parameters of the urinary catheter before and after the clamping operation; The control module is in communication with the sensor module and the parameter calibration module, and is used to dynamically adjust the clamping pressure according to the geometric parameters; and to fuse the flow rate signal with the deformation distribution data to generate a calibrated urine flow value.

2. A urinary catheter external clamp type urine volume monitoring device according to claim 1, characterized in that: The parameter calibration module includes a laser scanning unit and an image processing unit. The laser scanning unit is used to emit a circular laser beam to scan the outer surface of the catheter before clamping. The image processing unit is used to calculate the geometric parameters of the catheter based on Moire fringe analysis.

3. A urinary catheter external clamp type urine volume monitoring device according to claim 2, characterized in that: The laser scanning unit includes a wavelength-tunable VCSEL array, which is used to adaptively select the optimal working wavelength according to the material of the urinary catheter.

4. The urinary catheter external clamp type urine volume monitoring device according to claim 1, characterized in that: The clamping body module comprises a shape memory alloy actuating layer and an elastic reset layer, and the phase change temperature range of the shape memory alloy actuating layer is close to the surface temperature of the human body.

5. The catheter external clamp type urine volume monitoring device according to claim 1, characterized in that: The control module is integrated with a dynamic compensation algorithm library, which contains differentiated processing models for steady flow, pulsating flow and intermittent flow.

6. A method for monitoring urine volume by clamping a urinary catheter externally, based on the urinary catheter clamping type urine volume monitoring device according to any one of claims 1 to 5, characterized in that: The following steps are involved: S1. Using the laser scanning unit of the parameter calibration module to perform circular laser scanning on the outer surface of the urinary catheter to obtain three-dimensional morphological data of the outer wall of the urinary catheter; combining with the pre-stored material property database, calculating the initial clamping parameter set, the initial clamping parameter set includes the clamping force range and the deformation threshold; S2. According to the initial clamping parameter set obtained in S1, a pre-tightening force is applied through the shape memory alloy actuation layer of the clamping structure; the circumferential deformation data of the urinary catheter is collected in real time by using the deformation detection unit, and when the deformation data meets the preset stability condition, a stable clamping signal is output; S3. After receiving the stable clamping signal output by S2, the flow rate detection unit is used to synchronously collect the urine flow rate signal, and the deformation detection unit is used to collect the circumferential strain gradient data of the urinary tube; S4. Input the velocity signal and strain gradient data collected in S3 into the dynamic compensation algorithm library of the control module to generate a real-time calibration coefficient; S5. Based on the real-time calibration coefficient obtained in S4, the collected original flow rate signal is corrected to calculate the calibrated instantaneous urine flow rate and cumulative urine volume value; S6. Periodically compare the cumulative urine volume value calculated in S5 with the weighing reference value measured by the independent weighing sensor; if the deviation of the comparison result exceeds the set threshold, the S1 step is triggered to recalibrate the parameters.

7. A method for monitoring urine volume using a urinary catheter external clamp according to claim 6, characterized in that: The S1 step specifically includes: S11. Using a laser scanning unit to emit a circular laser beam to scan the outer surface of the urinary catheter to obtain an interference fringe image of the outer surface of the urinary catheter; S12. Based on the interference fringe image, the original outer diameter of the urinary catheter is calculated by Moire fringe analysis; S13. According to the material information of the urinary catheter, a matching elastic modulus and Poisson's ratio are searched from a pre-stored material property database; S14. Calculate the maximum allowable deformation of the urinary catheter based on the elastic modulus, Poisson's ratio and material creep characteristics of the urinary catheter; S15. Generate an initial clamping parameter set including a clamping force range and a deformation threshold according to the original outer diameter, elastic modulus, Poisson's ratio and maximum allowable deformation of the urinary catheter.

8. A method for monitoring urine volume using a urinary catheter external clamp according to claim 6, characterized in that: The S2 step specifically includes: S21. Calling the clamping force range in the initial clamping parameter set generated in step S1, and applying a preload force through the shape memory alloy actuation layer; S22. Using the deformation detection unit to collect the circumferential pressure distribution data of the urinary catheter in real time; S23. Calculate the pressure uniformity index based on the collected pressure distribution data, and dynamically adjust the clamping force through the control module so that the clamping force is evenly distributed around the urinary catheter; S24. When the collected deformation data exceeds the deformation threshold set in step S1, the decompression protection mechanism of the control module is triggered to reduce the clamping force to a safe range; S25. When the deformation data remains stable under the preset stability conditions, a stable clamping signal is output to step S3.

9. A method for monitoring urine volume using a urinary catheter external clamp according to claim 6, characterized in that: The S4 step specifically includes: S41. Performing spectrum analysis on the velocity signal collected in step S3 to extract the spectrum characteristics of the velocity signal; and processing the collected strain gradient data to obtain the spatial distribution characteristics of the strain gradient; S42. Combining the extracted flow velocity signal spectrum characteristics and strain gradient spatial distribution characteristics into a feature vector, inputting the feature vector into the timing neural network of the control module, and generating a calibration coefficient; S43. Using the calibration coefficient generated in step S42, dynamically correct the original flow rate signal collected in step S3 to obtain a calibrated flow rate signal; S44. When the confidence level of the calibration coefficient evaluated by the time series neural network is lower than the set threshold, the abnormal alarm mechanism is triggered.

10. A method for monitoring urine volume using a urinary catheter external clamp according to claim 6, characterized in that: Step S6 specifically includes: S61. During the urine volume monitoring process, periodically comparing the cumulative urine volume value calculated in step S5 with the weighing reference value measured by the independent weighing sensor; S62. If the deviation of the comparison result exceeds the set threshold, it is determined that the monitoring device may have an error or the catheter parameters have changed, triggering step S1 to recalibrate the parameters and update the material parameters; S63. The deviation data of the comparison result is encrypted and uploaded to the cloud database through the wireless communication module for storage and analysis; S64. Generate a calibration report based on the comparison results and recalibration information, and push it to the terminal device of the medical staff through the wireless communication module.

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