Leakage-proof urinary catheter fixing device and intelligent nursing system thereof

Abstract

The present application relates to the technical field of catheter fixing, and provides a urine leakage prevention catheter fixing device and an intelligent nursing system thereof, which comprises a fixing module made of medical silica gel material in a ring structure, has excellent flexibility, biocompatibility and antibacterial property, and can avoid stimulating urethral mucosa and surrounding skin; the inner diameter of the ring structure is self-adaptively adjusted through an embedded elastic belt and a buckle type adjusting mechanism; a urine leakage prevention module is integrated at one end of the fixing module facing the urethral orifice and is composed of a ring-shaped sealing pad and a leakage prevention ring; the ring-shaped sealing pad is made of medical water-absorbing and swelling cotton material, is attached to the skin around the urethral orifice, and can quickly absorb a small amount of exuded urine. Through medical-grade material and scientific structure design, the urine leakage prevention catheter fixing device realizes double protection of stable fixing of the catheter and prevention of urine leakage. The fixing module has good adaptability and anti-skid performance, and can avoid displacement and slipping of the catheter; the urine leakage prevention module can quickly absorb exuded urine and block diffusion, and reduces the risk of skin irritation and inflammation.

Description

Technical Field

[0001] This invention relates to the field of catheter fixation technology, specifically to a catheter fixation device for preventing urine leakage and its intelligent nursing system. Background Technology

[0002] Urinary catheterization is a commonly used medical procedure in clinical practice, used to address patients' needs for urination obstruction and postoperative urine drainage. The stable fixation of the catheter and the sealing and protection of the urethral orifice are the core points of catheterization care. Currently, the catheter fixation methods used in clinical practice are mostly traditional adhesive tape fixation and clip-on fixation devices, which have many technical defects: First, the fixation effect depends on the nursing staff's operating experience, and the fixation pressure is difficult to control precisely. Too high pressure can easily compress the urethral mucosa and cause damage, while too low pressure can easily lead to catheter displacement or slippage, resulting in unplanned extubation. This not only affects the continuity of treatment but may also cause complications such as urethral tears and bleeding. Second, there is a lack of effective means of detecting urine leakage. After urine leakage, it often requires manual inspection by nursing staff to discover it. After leakage, urine will irritate the skin around the urethral opening for a long time, which can easily induce urinary tract infections and skin inflammation, while also increasing the nursing workload. Third, the existing fixation devices are disconnected from the nursing process and lack an intelligent early warning mechanism. Nursing staff cannot monitor the catheter fixation status and urethral opening environment in real time and can only check for risks through periodic inspections. This leads to delayed early warning and passive risk control, further increasing the incidence of infection and unplanned extubation, seriously affecting the safety of medical care and the patient's medical experience.

[0003] To address the aforementioned issues, while some existing technologies attempt to optimize urinary catheter fixation, most focus only on single-function improvements, such as simply strengthening the fixation structure or adding basic leakage detection elements. They fail to form an integrated system encompassing "fixation control - status detection - intelligent early warning - nursing prompts," thus lacking dynamic and coordinated control of fixation pressure and leakage status. Furthermore, they lack personalized parameter settings, making it difficult to adapt to the different physiological characteristics and nursing needs of various patients. Their safety, applicability, and level of intelligence fail to meet the requirements of refined clinical nursing. Therefore, developing an integrated urinary catheterization nursing solution that combines precise fixation, real-time monitoring, and intelligent early warning functions has become a pressing technical problem in the current medical and nursing field. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides a urine catheter fixation device and its intelligent nursing system to prevent urine leakage, solving the problems of inaccurate fixation, delayed urine leakage detection, lack of intelligent early warning, and passive risk prevention and control.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a urine catheter fixation device for preventing urine leakage, comprising:

[0006] Fixation Module: Made of medical-grade silicone, this ring-shaped structure possesses excellent flexibility, biocompatibility, and antibacterial properties, preventing irritation to the urethral mucosa and surrounding skin. The inner diameter of the ring structure is adaptively adjustable via a built-in elastic band and snap-on adjustment mechanism, allowing for a tight fit to the outer wall of catheters of different diameters. The outer wall of the ring structure features anti-slip textures to prevent catheter displacement due to patient limb movement. The fixation module is mounted at the end of the catheter near the urethral opening.

[0007] Leakage prevention module: Integrated into the fixed module at the end facing the urethral opening, it consists of an annular sealing pad and a leak-proof retaining ring; the annular sealing pad is made of medical absorbent and expandable cotton material, which conforms to the skin around the urethral opening, can quickly absorb a small amount of leaked urine, and expands with water absorption to enhance the sealing effect and prevent further leakage of urine; the leak-proof retaining ring is an annular raised structure that seamlessly connects with the outer side of the annular sealing pad, preventing the absorbed urine from spreading to the surrounding skin and reducing the risk of skin inflammation.

[0008] Preferably, the elastic band is made of medical-grade polyurethane (TPU) material, which has both high elasticity and anti-aging properties. The elastic coefficient is set to 1.5-2.5 N / mm², which can withstand repeated stretching and is not easily deformed, and can maintain stable fixation force for a long time.

[0009] Preferably, the buckle adjustment mechanism has three positions, corresponding to the following inner diameter adjustment range:

[0010] The first setting is suitable for 8mm-10mm catheters and 12Fr-14Fr catheters.

[0011] The second setting is suitable for catheters with diameters of 11mm-13mm and diameters of 16Fr-20Fr.

[0012] Three sizes are available to fit 14mm-15mm catheters and 22Fr-24Fr catheters.

[0013] The gear shifting is clear, allowing caregivers to adjust it quickly and accurately.

[0014] Preferably, the anti-slip texture has a depth of 0.3mm-0.5mm and a spacing of 2mm-3mm, and adopts an alternating concave-convex design to enhance friction with skin and clothing.

[0015] Preferably, the annular sealing pad has a base thickness of 5mm-7mm, a water absorption ratio of 20-30 times its own weight, and can reach more than 80% of its maximum expansion within 30 seconds. After fully absorbing water and expanding, its thickness can reach 12mm-15mm, which can tightly fill the gap between the urethral opening and the fixing module.

[0016] Preferably, the leak-proof ring and the fixing module are integrally molded, both made of medical-grade silicone, with a height of 2mm-3mm and a rounded arc of R2mm-R3mm, without sharp edges or corners, so that there is no pressure when it fits the skin, and at the same time it can effectively prevent the side leakage of urine after absorption.

[0017] A smart nursing system for a leak-proof catheter fixation device includes a sensor module. The sensor module consists of two symmetrically arranged piezoresistive pressure sensors and one capacitive humidity sensor, all using medical-grade high-precision components to ensure reliable data. The pressure sensors are embedded in the inner wall of the fixation module, in close contact with the outer wall of the catheter, and collect radial fixation pressure values ​​in real time. The humidity sensor is embedded inside the annular sealing pad, close to the skin surface at the urethral opening, and detects the humidity values ​​of the skin and the annular sealing pad in real time. The sensor module has a built-in Bluetooth BLE 5.0 wireless transmission unit, coupled with a long-life button battery, which can transmit the collected pressure and humidity data to a nursing terminal in real time.

[0018] A smart nursing method for a urine catheter fixation device to prevent urine leakage includes the following steps:

[0019] Step 1: Parameter Preset

[0020] Nursing staff can create personalized care plans by pre-setting core control parameters through the nursing terminal based on the patient's age, physiological characteristics, catheter type, and condition. The preset parameters include: fixed pressure threshold range; humidity warning threshold; catheter replacement cycle; the parameters are automatically synchronized to the data processing stage after being preset, and used as the basis for judgment.

[0021] Step 2: Real-time Data Reception and Processing

[0022] The nursing terminal continuously receives pressure and humidity data uploaded by the fixed device's sensor module, and simultaneously filters and calibrates the data to remove interfering data and ensure data accuracy. At the same time, the terminal displays the patient's bed number, name, current pressure value, humidity value, and remaining replacement time in real time, providing nursing staff with visual monitoring data and replacing the traditional manual inspection mode.

[0023] Step 3: Triggering Multi-Condition Early Warning

[0024] A multi-parameter linkage early warning logic is established. The terminal compares the real-time processed data with preset thresholds. An early warning is triggered when any of the following conditions are met: the pressure value is lower than the preset lower limit or higher than the preset upper limit; the humidity value is higher than the early warning threshold; or the preset catheter replacement cycle is reached. The early warning is provided through audible and visual prompts and terminal push notifications. The indicator light flashes and emits a low-volume buzzer. At the same time, an early warning window pops up on the nursing terminal and a reminder is pushed to the mobile APP. The warning type and corresponding patient information are clearly marked to achieve accurate early warning.

[0025] Step 4: Targeted Nursing Intervention

[0026] After receiving the warning information, nursing staff go to the patient's location to implement corresponding interventions: when the pressure is abnormal, adjust the elastic band of the fixation module to adjust the pressure value to a preset reasonable range; when the humidity is abnormal, replace the leak-proof ring and the ring-shaped sealing gasket, clean the skin around the urethral opening, and check for catheter displacement; when the replacement cycle is reached, replace the catheter and fixation device according to the standard procedure, update the terminal parameters simultaneously, and restart the monitoring function; after the intervention is completed, the nursing staff enters the processing results into the terminal to form a nursing record;

[0027] Step 5: The terminal automatically encrypts and stores data, including pressure / humidity, early warning events, parameter setting records, and nursing intervention results.

[0028] Preferably, the pressure threshold range in step one is 0.1MPa-0.3MPa. When it is below the lower limit, it indicates a risk of dislodgement, and when it is above the upper limit, it indicates a risk of mucosal damage. The humidity warning threshold is ≥30%. When the relative humidity is ≥30%, it indicates urine leakage. The catheter replacement cycle is every 7 days / 14 days, customized according to the type of catheter and the patient's recovery.

[0029] Preferably, the storage period in step five is no less than 90 days, and it supports connection with the hospital HIS system and nursing management system to achieve data sharing and traceability, providing data support for nursing quality analysis and process optimization, while meeting medical quality control requirements.

[0030] Working principle: First, the nursing staff determines the corresponding setting of the snap-on adjustment mechanism based on the model of the urinary catheter used by the patient. Setting one is suitable for 12Fr-14Fr catheters, setting two for 16Fr-20Fr catheters, and setting three for 22Fr-24Fr catheters. Ensure the adjustment mechanism is in an unlocked, adjustable state. Then, insert the annular structure of the fixing module from the end of the catheter and move it close to the urethral opening, ensuring the annular sealing gasket of the anti-leakage module faces the urethral opening, ensuring the annular sealing gasket can automatically... Then, press the operating end of the snap-on adjustment mechanism against the skin around the urethral opening, pull the ring structure to contract the built-in elastic band until the inner wall of the ring structure is tightly against the outer wall of the catheter. Release the operating end, and the snap-on adjustment mechanism will be engaged in the corresponding position slot under the action of the spring force, thus completing the fixation. At this time, the anti-slip texture on the outer wall of the fixing module forms friction with the skin and clothing, further preventing the catheter from shifting. The pressure sensor is in close contact with the outer wall of the catheter, and the humidity sensor is close to the skin surface of the urethral opening.

[0031] Nursing staff, using a nursing terminal, preset fixed pressure threshold ranges, humidity warning thresholds, and catheter replacement cycles based on the patient's age, physiological characteristics, catheter type, and condition. These parameters are automatically synchronized to the data processing stage. Two piezoresistive pressure sensors in the sensing module collect real-time radial fixed pressure values ​​of the catheter, while a capacitive humidity sensor detects real-time humidity levels of the urethral opening skin and the annular sealing gasket. The collected data is transmitted to the nursing terminal in real-time via a built-in Bluetooth BLE 5.0 wireless transmission unit. After continuously receiving data, the nursing terminal uses algorithms such as outlier filtering, timing consistency verification, sensor linkage verification, and environmental interference compensation to eliminate interfering data, ensuring data accuracy. It also displays the patient's bed number, name, current pressure value, humidity value, and remaining replacement time in real-time. The terminal compares the processed data with preset thresholds. If the pressure value exceeds the threshold range, the humidity value exceeds the warning threshold, or the catheter replacement cycle is reached, it immediately triggers an audible and visual alert and push notification, clearly indicating the warning type and patient information. Upon receiving an alert, nursing staff take targeted actions: when pressure is abnormal, adjust the elastic band to bring the pressure value to a reasonable range; when humidity is abnormal, replace the annular sealing gasket and leak-proof ring, clean the skin, and check the catheter position; when the replacement cycle is reached, replace the catheter and fixation device according to specifications, update terminal parameters, restart monitoring, and record the intervention results to form a nursing record. The nursing terminal automatically encrypts and stores pressure / humidity data, alert events, parameter settings, and intervention results for a period of no less than 90 days, and supports integration with the hospital's HIS system and nursing management system to achieve data sharing and traceability.

[0032] This invention provides a urine catheter fixation device to prevent urine leakage and its intelligent nursing system. It has the following beneficial effects:

[0033] 1. This invention achieves both stable catheter fixation and leak-proof protection through medical-grade materials and a scientifically designed structure. The fixation module has excellent adaptability and anti-slip properties, preventing catheter displacement and slippage; the leak-proof module can quickly absorb exudate and block its spread, reducing the risk of skin irritation and inflammation. Simultaneously, the material has excellent biocompatibility, is non-irritating, and improves patient comfort. This invention solves the problems of mucosal damage and leakage that are easily caused by traditional fixation methods, enhancing the safety and reliability of catheter care.

[0034] 2. This invention uses a sensor module to monitor fixed pressure and urethral opening humidity in real time. Combined with personalized parameter presets and a multi-condition early warning mechanism, it can achieve accurate risk prediction and timely reminders, replacing traditional manual inspections, reducing the workload of nursing staff. At the same time, through standardized intervention procedures and data traceability functions, it ensures the standardization and traceability of nursing operations, effectively reducing the risk of complications such as infection and unplanned catheter removal, and improving the intelligence and precision of urinary catheter care. Attached Figure Description

[0035] Figure 1 This is a flowchart of the present invention;

[0036] Figure 2 This is a schematic diagram of the fixing device of the present invention.

[0037] Among them, 1. Ring structure; 2. Elastic strap; 3. Buckle-type adjustment mechanism; 4. Anti-slip texture; 5. Ring sealing gasket; 6. Leak-proof retaining ring; 7. Piezoresistive pressure sensor; 8. Capacitive humidity sensor. Detailed Implementation

[0038] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0039] Example:

[0040] Please see the appendix Figure 1 - Appendix Figure 2 This invention provides a urine catheter fixation device to prevent urine leakage, comprising:

[0041] Fixation Module: A ring-shaped structure 1 made of medical-grade silicone possesses excellent flexibility, biocompatibility, and antibacterial properties, preventing irritation to the urethral mucosa and surrounding skin. The inner diameter of the ring-shaped structure 1 is adaptively adjustable via a built-in elastic band 2 and a snap-fit ​​adjustment mechanism 3, allowing for a tight fit to the outer wall of catheters of different diameters. The outer wall of the ring-shaped structure 1 features anti-slip textures 4 to prevent catheter displacement due to patient limb movement. The fixation module is mounted at the end of the catheter near the urethral opening. The elastic band 2 is made of medical-grade polyurethane TPU, combining high elasticity and anti-aging properties. The elasticity coefficient is set at 2.5 N / mm², allowing it to withstand repeated stretching without deformation and maintain stable fixing force over a long period. The buckle adjustment mechanism 3 includes: an adjustment base, integrally formed with the annular structure 1, in an arc-shaped block structure, embedded in a pre-reserved groove on the outer wall of the annular structure 1, with its surface flush with the outer wall of the annular structure 1, without affecting the anti-slip texture 4 function; the base has a stop slot and an elastic strap 2 fixing slot inside, made of the same material as the annular structure 1, possessing biocompatibility and flexibility; and a movable buckle, made of medical-grade polyurethane TPU material, in an L-shape, including an operating end and a locking end. The operating end is exposed on the surface of the adjustment base and features anti-slip raised textures for easy pressing / flicking by caregivers. The engaging end has a built-in micro-spring for elastic extension and retraction, precisely engaging with the gear position slots. The gear position slots consist of three independent slots inside the adjustment base along the stretching direction of the elastic band, corresponding to three different inner diameter adjustment requirements. The slots are wedge-shaped with guide bevels at the openings to facilitate smooth insertion of the engaging end. The slot depth matches the size of the engaging end, ensuring a secure and stable engagement. The elastic band 2 connection end has a band fixing groove on the inner side of the adjustment base, where both ends of the elastic band 2 are fixed. Within the groove, when the buckle engages with different slots, the elastic band 2 contracts or expands, thereby adjusting the inner diameter of the annular structure 1. Anti-slip teeth are provided on the inner wall of the fixed groove to enhance the stability of the elastic band 2 and prevent displacement over long-term use. The buckle adjustment mechanism 3 has three positions, corresponding to the following inner diameter adjustment ranges: Position 1 is suitable for 8mm-10mm catheters (12Fr-14Fr); Position 2 is suitable for 11mm-13mm catheters (16Fr-20Fr); and Position 3 is suitable for 14mm-15mm catheters (22Fr-24Fr). The anti-slip texture 4 has a depth of 0.3mm and a spacing of 2mm, employing an alternating concave-convex design to enhance friction with skin and clothing. When switching positions, the nurse presses the operating end of the movable locking device, compressing the built-in micro spring and disengaging the locking end from the current slot. Then, depending on the catheter model, the nurse pulls the ring structure or pushes the locking device to stretch or contract the elastic band to the corresponding position. Releasing the operating end allows the locking end to engage with the target slot under the spring's force, completing the adjustment. Position switching is clear, the operating stroke is short, and positioning is quick and accurate.

[0042] Based on the structural dimensions and assembly requirements of the fixation device, high-precision injection molds and vulcanizing molds were designed. The molds are made of medical-grade stainless steel with a polished surface and a roughness Ra≤0.8μm to ensure a smooth, burr-free surface on the molded product, avoiding skin irritation. The molds must include pre-reserved slots for sensor mounting, battery compartments, and wireless transmission module cavities to ensure precise assembly of all components.

[0043] Leakage Prevention Module: Integrated into the fixed module at the end facing the urethral opening, it consists of a ring-shaped sealing pad 5 and a leak-proof retaining ring 6. The ring-shaped sealing pad 5 is made of medical-grade absorbent and expandable cotton, conforming to the skin around the urethral opening. It can quickly absorb small amounts of leaked urine, and its expansion with water absorption strengthens the sealing effect, preventing further leakage. The leak-proof retaining ring 6 has a ring-shaped raised structure that seamlessly connects with the outer side of the ring-shaped sealing pad 5, preventing the absorbed urine from spreading to the surrounding skin and reducing the risk of skin inflammation. The ring-shaped sealing pad 5 has a basic thickness of 5-7mm, an absorption rate of 20-30 times its own weight, and can reach more than 80% of its maximum expansion within 30 seconds. After full absorption and expansion, its thickness can reach 12mm, which can tightly fill the gap between the urethral opening and the fixed module. The leak-proof retaining ring 6 is integrally molded with the fixed module, both made of medical-grade silicone. Its height is set at 2mm, and its curvature is a rounded arc of R2mm, without sharp edges or corners. It does not cause pressure when conforming to the skin, while effectively preventing the side leakage of absorbed urine.

[0044] Eighty patients undergoing catheterization at the urology and geriatrics departments of a tertiary hospital were randomly divided into an experimental group (using the device and intelligent nursing system of this invention) and a control group (using a traditional catheter fixation device and manual inspection), with 40 patients in each group. The experimental group consisted of 22 males and 18 females, aged 45-82 years, with a mean age of 63.5 ± 8.2 years; the control group consisted of 23 males and 17 females, aged 43-85 years, with a mean age of 64.2 ± 7.8 years. There were no statistically significant differences between the two groups in terms of age, sex, catheterization type, or disease severity, making them comparable. The trial period was 14 days.

[0045] The key indicator data for the experimental group are shown in Table 1:

[0046] Table 1

[0047] The data comparison with the control group is shown in Table 2:

[0048] Table 2

[0049] A smart nursing system for a leak-proof catheter fixation device includes a sensing module. The sensing module consists of two symmetrically arranged piezoresistive pressure sensors 7 and a capacitive humidity sensor 8, all employing medical-grade high-precision components to ensure reliable data. The piezoresistive pressure sensor 7 is embedded in the inner wall of the fixation module, in close contact with the outer wall of the catheter, and collects radial fixation pressure values ​​in real time. The capacitive humidity sensor 8 is embedded inside the annular sealing gasket 5, close to the skin surface of the urethral opening, and detects the humidity values ​​of the skin and the annular sealing gasket 5 in real time. The detection probe surface of the capacitive humidity sensor 8 is covered with a medical-grade breathable film. The breathable membrane has a pore size of 0.2μm, which allows humidity signals to pass through while preventing contaminants such as sweat and secretions from directly contacting the sensor probe, thus extending the sensor's lifespan and avoiding the risk of cross-infection. The sensor module has a built-in Bluetooth BLE5.0 wireless transmission unit, which, when paired with a long-life button battery, can transmit the collected pressure and humidity data to the nursing terminal in real time. The button battery features a replaceable design, and the battery compartment cover is fixed by a rotating buckle. It can be opened without special tools, and nursing staff can quickly replace the battery under aseptic conditions without disassembling the entire fixing device, thus not affecting the fixation of the urinary catheter.

[0050] A smart nursing method for a urine catheter fixation device to prevent urine leakage includes the following steps:

[0051] Step 1: Parameter Preset

[0052] Nursing staff can create personalized care plans by pre-setting core control parameters through a nursing terminal based on the patient's age, physiological characteristics, catheter type, and condition. These preset parameters include: a fixed pressure threshold range of 0.1MPa-0.3MPa; pressure below the lower limit indicates a risk of dislodgement, while pressure above the upper limit indicates a risk of mucosal damage; a humidity warning threshold; and a catheter replacement cycle of every 7 / 14 days, customized according to the catheter type and the patient's recovery status. These parameters are automatically synchronized to the data processing stage after being preset, serving as a basis for judgment.

[0053] Step 2: Real-time Data Reception and Processing

[0054] The nursing terminal continuously receives pressure and humidity data uploaded by the fixed device's sensor module, and simultaneously filters and calibrates the data to remove interfering data and ensure data accuracy. At the same time, the terminal displays the patient's bed number, name, current pressure value, humidity value, and remaining replacement time in real time, providing nursing staff with visual monitoring data and replacing the traditional manual inspection mode.

[0055] Step 3: Multi-condition early warning triggering. Establish a multi-parameter linkage early warning logic. The terminal compares the real-time processed data with preset thresholds. An early warning is triggered if any condition is met: the pressure value is lower than the preset lower limit or higher than the preset upper limit; the humidity value is higher than the early warning threshold; or the preset catheter replacement cycle is reached. The early warning is triggered by sound and light prompts and terminal push notifications. The indicator light flashes and emits a low-volume buzzer. At the same time, the nursing terminal pops up an early warning window and the mobile APP pushes a reminder, clearly indicating the early warning type and corresponding patient information to achieve accurate early warning.

[0056] Step 4: Targeted nursing intervention. After receiving the warning information, nursing staff will go to the patient to implement corresponding interventions: When the pressure is abnormal, adjust the elastic band of the fixation module to adjust the pressure value to a preset reasonable range; when the humidity is abnormal, replace the leak-proof ring and the ring sealing gasket, clean the skin around the urethral opening, and check for catheter displacement; when the replacement cycle is reached, replace the catheter and fixation device according to the standard procedure, update the terminal parameters simultaneously, and restart the monitoring function; after the intervention is completed, the nursing staff will enter the processing results into the terminal to form a nursing record.

[0057] Step 5: The terminal automatically encrypts and stores data, including pressure / humidity, early warning events, parameter setting records, and nursing intervention results. The storage period is no less than 90 days. It supports the connection with the hospital HIS system and nursing management system to achieve data sharing and traceability, providing data support for nursing quality analysis and process optimization, while meeting medical quality control requirements.

[0058] The algorithm for processing nursing terminal data is a logic for removing interfering data, as detailed below:

[0059] Preliminary screening of outliers: Based on the 3σ principle, reasonable distribution ranges are set for pressure data between 0.1MPa and 0.3MPa and humidity data between 0% and 100%. When a single data collection exceeds the ±3σ range of this range, it is judged as an extreme outlier and is directly removed.

[0060] Temporal consistency verification: Trend analysis is performed on 5 consecutive sets of collected data. The sampling frequency is 1Hz, that is, data within 5 seconds. If the fluctuation amplitude of adjacent data exceeds the preset threshold, that is, pressure ±0.05MPa, humidity ±10%, and there is no reasonable physical cause, such as no limb movement record of the patient, it is judged as interference data. The stable data segment before and after is retained, and the abnormal fluctuation segment is removed.

[0061] By combining the acquisition timing of the piezoresistive pressure sensor 7 and the capacitive humidity sensor 8, if the data of a single sensor changes abruptly while the data of the other sensor remains stable and there is no corresponding patient care operation record, it is determined to be isolated interference data of that sensor. The sliding average of the first three valid data is used to replace it, realizing sensor status linkage verification. The built-in environmental humidity calibration factor automatically corrects the humidity detection data of the annular sealing gasket 5 when the nursing terminal detects that the environmental humidity exceeds the standard range of 20%-60%. For example, for every 10% increase in environmental humidity, the humidity detection value correction coefficient is reduced by 5%, avoiding misjudgment caused by environmental humidity, thereby realizing environmental interference compensation.

[0062] Interface protocol and data encryption standard for connecting nursing terminals and HIS systems

[0063] The nursing terminal adopts the HL7FHIRV4.0 standard interface protocol to achieve seamless integration with the hospital's HIS system and nursing management system. The specific interaction process is as follows:

[0064] Data Upload: Nursing terminals upload encrypted nursing data in batches once per hour, including pressure / humidity records, early warning events, intervention results, etc., and send them to the hospital data exchange platform via HTTP / HTTPS protocol. The interface request format is JSON, which includes core fields such as the patient's unique medical record number, device number, data timestamp, and data type.

[0065] Data synchronization: Patient basic information, including name, age, bed number, diagnosis, and catheterization type, is synchronized from the HIS system; medical orders, such as catheter replacement cycle and nursing level, are also synchronized. Synchronization occurs automatically every morning and is also triggered manually in real-time.

[0066] Interface Adaptation: Supports adaptation with mainstream hospital information systems, providing configurable interface parameters such as server address, port number, and authentication information to meet the system environment requirements of different hospitals.

[0067] Furthermore, the nursing terminal uses the TLS 1.3 protocol to encrypt data transmission, ensuring secure data transmission between the nursing terminal and the hospital's data exchange platform and HIS system, preventing data interception or tampering. Local storage on the terminal uses the AES-256-GCM encryption algorithm to encrypt all sensitive data, including patient information, pressure / humidity data, and nursing records. The encryption key is centrally managed by the hospital's information department and automatically updated periodically. Nursing staff use a dual authentication mechanism of "username and password + dynamic verification code" to log in to the terminal. The username and password are stored after hashing using the PBKDF2 algorithm, while the dynamic verification code is generated by the hospital's unified authentication platform and is valid for 5 minutes to prevent unauthorized access.

[0068] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A urine catheter fixation device to prevent urine leakage, characterized in that, include: Fixing module: The ring structure (1) is made of medical silicone material, which has excellent flexibility, biocompatibility and antibacterial properties, and can avoid irritating the urethral mucosa and surrounding skin; the inner diameter of the ring structure (1) is adaptively adjusted by the built-in elastic band (2) and the buckle adjustment mechanism (3), which can fit tightly with the outer wall of catheters of different diameters; the outer wall of the ring structure (1) is provided with anti-slip texture (4) to prevent the catheter from shifting due to the patient's limb movement; the fixing module is assembled at the end of the catheter near the urethral opening; Leakage prevention module: Integrated into the fixed module at the end facing the urethral opening, it consists of an annular sealing pad (5) and a leak-proof ring (6); the annular sealing pad (5) is made of medical absorbent and expandable cotton material, which fits the skin around the urethral opening and can quickly absorb a small amount of leaked urine. As it absorbs water and expands, it strengthens the sealing effect and prevents further leakage of urine; the leak-proof ring (6) is an annular protrusion structure that is seamlessly connected to the outside of the annular sealing pad (5) to prevent the absorbed urine from spreading to the surrounding skin and reduce the risk of skin inflammation.

2. The urine catheter fixation device for preventing urine leakage according to claim 1, characterized in that, The elastic band (2) is made of medical-grade polyurethane TPU material, which has both high elasticity and anti-aging properties. The elastic coefficient is set to 1.5-2.5N / mm², which can withstand repeated stretching and is not easily deformed, and can maintain stable fixation force for a long time.

3. The urine catheter fixation device for preventing urine leakage according to claim 1, characterized in that, The buckle adjustment mechanism (3) has three positions, corresponding to the inner diameter adjustment range as follows: The first setting is suitable for 8mm-10mm catheters and 12Fr-14Fr catheters. The second setting is suitable for catheters with diameters of 11mm-13mm and diameters of 16Fr-20Fr. Three sizes are available to fit 14mm-15mm catheters and 22Fr-24Fr catheters. The gear shifting is clear, allowing caregivers to adjust it quickly and accurately.

4. The urine catheter fixation device for preventing urine leakage according to claim 1, characterized in that, The anti-slip texture (4) has a depth of 0.3mm-0.5mm and a spacing of 2mm-3mm. It adopts an alternating concave-convex design to enhance the friction with skin and clothing.

5. The urine catheter fixation device for preventing urine leakage according to claim 1, characterized in that, The annular sealing pad (5) has a base thickness of 5mm-7mm, a water absorption ratio of 20-30 times its own weight, and can reach more than 80% of its maximum expansion within 30 seconds. After fully absorbing water and expanding, its thickness can reach 12mm-15mm, which can tightly fill the gap between the urethral opening and the fixed module.

6. The urine catheter fixation device for preventing urine leakage according to claim 1, characterized in that, The leak-proof ring (6) is integrally formed with the fixing module. Both are made of medical silicone material, with a height of 2mm-3mm and a rounded arc of R2mm-R3mm. There are no sharp edges or corners, so there is no pressure when it fits the skin. At the same time, it can effectively block the side leakage of urine after absorption.

7. An intelligent nursing system for a urine-preventing catheter fixation device, using a urine-preventing catheter fixation device as described in any one of claims 1-6, characterized in that, The system includes a sensor module consisting of two symmetrically arranged piezoresistive pressure sensors (7) and a capacitive humidity sensor (8), all of which use medical-grade high-precision components to ensure reliable detection data. The piezoresistive pressure sensor (7) is embedded in the inner wall of the fixing module and is in close contact with the outer wall of the catheter to collect radial fixed pressure values ​​in real time. The capacitive humidity sensor (8) is embedded in the inner side of the annular sealing pad (5) and is close to the skin surface of the urethral opening to detect the humidity values ​​of the skin and the annular sealing pad (5) in real time. The sensor module has a built-in Bluetooth BLE5.0 wireless transmission unit and is equipped with a long-life button battery, which can transmit the collected pressure and humidity data to the nursing terminal in real time.

8. A smart nursing method for a urine-preventing catheter fixation device, using a urine-preventing catheter fixation device as described in any one of claims 1-6, characterized in that, Includes the following steps: Step 1: Parameter Preset Nursing staff can create personalized nursing plans by pre-setting core control parameters through the nursing terminal based on the patient's age, physiological characteristics, catheter type and condition. The preset parameters include: fixed pressure threshold range; humidity warning threshold; catheter replacement cycle; the preset parameters are automatically synchronized to the data processing stage as a basis for judgment. Step 2: Real-time Data Reception and Processing The nursing terminal continuously receives pressure and humidity data uploaded by the fixed device's sensor module, and simultaneously filters and calibrates the data to remove interfering data and ensure data accuracy. At the same time, the terminal displays the patient's bed number, name, current pressure value, humidity value, and remaining replacement time in real time, providing nursing staff with visual monitoring data and replacing the traditional manual inspection mode. Step 3: Triggering Multi-Condition Early Warning A multi-parameter linkage early warning logic is established. The terminal compares the real-time processed data with preset thresholds. An early warning is triggered when any of the following conditions are met: the pressure value is lower than the preset lower limit or higher than the preset upper limit; the humidity value is higher than the early warning threshold; or the preset catheter replacement cycle is reached. The early warning is provided through audible and visual prompts and terminal push notifications. The indicator light flashes and emits a low-volume buzzer. At the same time, an early warning window pops up on the nursing terminal and a reminder is pushed to the mobile APP. The warning type and corresponding patient information are clearly marked to achieve accurate early warning. Step 4: Targeted Nursing Intervention After receiving the warning information, the nursing staff went to the patient to implement the corresponding intervention: when the pressure was abnormal, the elastic band (2) of the fixation module was adjusted to adjust the pressure value to the preset reasonable range; when the humidity was abnormal, the leak-proof ring (6) and the ring sealing gasket (5) were replaced, the skin around the urethral opening was cleaned, and the catheter displacement was checked; when the replacement cycle was reached, the catheter and fixation device were replaced according to the standard procedure, the terminal parameters were updated synchronously, and the monitoring function was restarted; after the intervention was completed, the nursing staff entered the processing results on the terminal to form a nursing record; Step 5: The terminal automatically encrypts and stores data, including pressure / humidity, early warning events, parameter setting records, and nursing intervention results.

9. The intelligent nursing system for a urine catheter fixation device to prevent urine leakage according to claim 8, characterized in that, The pressure threshold range in step one is 0.1MPa-0.3MPa. When it is below the lower limit, it indicates a risk of dislodgement, and when it is above the upper limit, it indicates a risk of mucosal damage. The humidity warning threshold is ≥30%. When the relative humidity is ≥30%, it indicates urine leakage. The catheter replacement cycle is every 7 days / 14 days, customized according to the type of catheter and the patient's recovery.

10. The intelligent nursing system for a urine-preventing catheter fixation device according to claim 8, characterized in that, The storage period in step five is no less than 90 days, and it supports integration with the hospital's HIS system and nursing management system to achieve data sharing and traceability, providing data support for nursing quality analysis and process optimization, while also meeting medical quality control requirements.

Images