Pressure sensor-based venous infusion extravasation detection device

Abstract

The application discloses a kind of based on pressure sensor's intravenous infusion exosmosis detection device, it is related to intravenous infusion exosmosis detection tool technical field.The device includes adhesive tape, dustless belt, sterile dressing, insulating shell, intelligent processing module and interactive platform, sterile dressing is built-in magnesium sulfate storage cavity and slow-release switch, and inlay has the sensing mechanism of the pressure physical signal of collection puncture site;The intelligent processing module in insulating shell is detachable, can receive sensing mechanism signal and conversion, filter amplification generation exosmosis detection electric signal, by bluetooth and wireless radio frequency dual-mode transmission to interactive platform.This device realizes exosmosis whole process automation prevention and control, solves the pain point of traditional detection lag, high cost, management disorder, improves nursing efficiency, guarantees patient safety, with safety, economy and management.

Description

Technical Field

[0001] This invention relates to the field of intravenous infusion extravasation detection devices, and more particularly to intravenous infusion extravasation detection devices based on pressure sensors. Background Technology

[0002] Intravenous infusion is widely used in medical institutions at all levels as a core means of clinical disease treatment, nutritional support, and emergency resuscitation. However, extravasation is a common complication. Influenced by factors such as the patient's vascular condition (e.g., arteriosclerosis in elderly patients, and thin blood vessels in infants and young children), the skill level of the puncture operator, the patient's limb movement, and the irritant nature of the medication, extravasated medication can easily accumulate under the skin. If not intervened in time, it may cause local swelling, pain, and even tissue necrosis and ulceration. Especially in patients who are comatose or have cognitive impairment and cannot express themselves, extravasation often results in serious consequences by the time it is detected. Furthermore, manual, timed inspections have time intervals, easily missing the opportunity for early intervention. Traditional infusion dressings only have the function of fixing the needle and lack the ability to detect extravasation.

[0003] While some pressure-sensing extravasation detection devices exist in the current technology, most can only achieve single pressure acquisition and lack integrated signal processing, graded early warning and automatic drug intervention functions. Furthermore, they lack a unified interactive platform for device management and data storage. The connection between the intelligent module and the sensing mechanism is unstable, inconvenient to disassemble and assemble, and difficult to reuse, resulting in high clinical usage costs. Therefore, it is necessary to propose a pressure sensor-based intravenous infusion extravasation detection device to solve the above problems. Summary of the Invention

[0004] The purpose of this invention is to address the shortcomings of existing technologies by proposing a pressure sensor-based extravasation detection device for intravenous infusion.

[0005] To achieve the above objectives, the present invention adopts the following technical solution: a pressure sensor-based intravenous infusion extravasation detection device, comprising an adhesive tape and a dust-free tape attached to the lower end of the adhesive tape, characterized in that: a sterile dressing is installed at the center of the bottom surface of the adhesive tape to fit the infusion needle hole, and the sterile dressing also has a built-in magnesium sulfate storage chamber for storing magnesium sulfate solution, and a slow-release switch is provided on the magnesium sulfate storage chamber; a sensing mechanism for sensing the pressure at the infusion needle hole is installed inside the sterile dressing, and an insulating shell is provided at the center of the top surface of the adhesive tape, and a detachable intelligent processing module is installed inside the insulating shell; The sensing mechanism is used to collect the physical pressure signal at the infusion puncture site; The intelligent processing module is used to receive the pressure physical signal of the infusion puncture site collected by the sensing mechanism, convert the pressure physical signal into an electrical signal, and generate an extravasation detection electrical signal after preliminary processing such as filtering and amplification of the electrical signal. It also includes an interactive platform independently set up with the device; the intelligent processing module and the interactive platform establish a two-way communication connection through Bluetooth and wireless radio frequency dual-mode signal transmission; the interactive platform includes functions such as extravasation detection electrical signal processing, infusion puncture site status observation, pressure data historical change trend prediction, extravasation early warning, registration and login, authorized mobile terminal management, device registration and binding, and extravasation detection signal data storage. The intelligent processor supports registration operations, and the interactive platform marks the registered intelligent processors and realizes unified authorization management of all devices under the same owner. Only authorized mobile terminals can log in to the interactive platform and perform related functions.

[0006] Preferably, the sensing mechanism includes a pressure sensor embedded inside the sterile dressing, two conductive pins fixed to the top surface of the sterile dressing, and an insulating protective sleeve sleeved on the outside of the pins. The insulating protective sleeve is coaxially arranged with a gap between the pins and the sensor. The pressure sensor is the core component of the sensing mechanism for collecting pressure physical signals, and the collected pressure physical signals are transmitted to the intelligent processing module through the pins.

[0007] Preferably, the positive terminal of the pressure sensor terminal is electrically connected to one of the contact pins, and the negative terminal of the pressure sensor terminal is electrically connected to the other contact pin; the top of the contact pin and the top of the insulating protective sleeve both penetrate the adhesive tape and extend to the upper surface of the adhesive tape, and the top of the contact pin protrudes from the top of the insulating protective sleeve.

[0008] Preferably, the intelligent processing module further includes an intelligent processor and a ring-shaped energy storage battery, with the intelligent processor located on one side of the ring-shaped energy storage battery; the intelligent processor integrates a Bluetooth communication unit for communicating with the interactive platform, a wireless radio frequency transceiver unit, and a power management unit to ensure signal processing.

[0009] Preferably, the insulating shell has symmetrical disassembly and assembly slots on both sides for easy disassembly and assembly, and two mounting slots adapted to the contact pin and insulating protective sleeve are provided at the bottom of the insulating shell. Each mounting slot is fixedly fitted with a damping sleeve. After the contact pin and insulating protective sleeve are inserted into the damping sleeve, the circuit between the sensing mechanism and the intelligent processing module is closed, and the damping sleeve and the contact pin are interference fit.

[0010] Preferably, the sterile dressing is a non-absorbent medical sterile elastic dressing made of medical polyurethane film, and the side of the sterile dressing that adheres to the skin is coated with low-sensitivity medical pressure-sensitive adhesive. The shape of the sterile dressing is adapted to the infusion puncture site.

[0011] Preferably, the registration and login function of the interactive platform includes processor registration and authorized mobile terminal registration. When the processor registers, it sends a unique identification code to the interactive platform. After the interactive platform verifies the code, it completes the attribution marking. The authorized mobile terminal completes the login through account password, verification code or biometric verification. Unregistered and unauthorized mobile terminals are prohibited from accessing the interactive platform and related data.

[0012] Preferably, the interactive platform enables unified authorization management of all devices under the same ownership entity for the intelligent processor that has completed the ownership marking, including operations such as adding, unbinding, status monitoring, and permission allocation of devices, and the interactive platform supports group management of devices under the same ownership entity.

[0013] Preferably, the specific process of processing the extravasation detection electrical signal in the interactive platform is as follows: The pressure sensor of the sensing mechanism collects the physical pressure signal of the infusion puncture site in real time and transmits it to the intelligent processing module. The intelligent processing module converts the physical pressure signal into an electrical signal, which is then filtered and amplified to generate an external leakage detection electrical signal, which is then transmitted to the interactive platform. The interactive platform performs signal noise reduction, feature extraction, and pressure value conversion on the received extravasation detection electrical signals. It then compares the conversion results with a preset three-level extravasation judgment range group to determine the extravasation risk level. The three-level extravasation judgment range group includes low-risk, medium-risk, and high-risk extravasation ranges. The platform then performs corresponding operations based on the extravasation judgment results. After extravasation is treated, nursing staff send a completion instruction to the interactive platform via an authorized mobile terminal. The interactive platform records the treatment duration and method, terminates the warning, and restores the intelligent processing module to real-time monitoring status.

[0014] Preferably, the extravasation detection signal data storage function of the interactive platform can store all extravasation detection electrical signals, converted pressure values, pressure change curves, early warning records, and prediction result reports transmitted by the intelligent processing module, and supports retrieval, filtering, and export of stored data according to the device's unique identification code, time, owner, and risk level.

[0015] Compared with the prior art, the beneficial effects of the present invention are: This invention enables real-time detection and tiered intervention, addressing the pain point of delayed detection of extravasation. 1. This solution uses a pressure sensor embedded in a sterile dressing to collect real-time physical pressure signals at the puncture site. These signals are then converted, filtered, and amplified by an intelligent processing module to generate an extravasation detection electrical signal. An interactive platform then performs noise reduction, pressure conversion, and a three-tiered risk assessment. For low-risk cases, a text warning is sent; for medium- to high-risk cases, an audible and visual warning is automatically triggered, the infusion pathway is closed, and the magnesium sulfate storage chamber's slow-release switch is activated for wet compresses. For high-risk cases, an additional emergency support reminder is sent, enabling real-time detection of extravasation, tiered response, and timely closed-loop management, significantly reducing the probability of serious consequences such as local swelling and tissue necrosis.

[0016] 2. This solution utilizes the disassembly slots on both sides of the insulating shell and the damping sleeve at the bottom to achieve rapid assembly and disassembly of the intelligent processing module and the sensing mechanism. The interference fit between the stylus and the damping sleeve ensures a stable connection. Medical personnel can easily disassemble the insulating shell through the disassembly slots, and the intelligent processing module can be disinfected and reused. The sterile dressing, as a disposable component, uses a non-absorbent medical polyurethane film and low-sensitivity pressure-sensitive adhesive, ensuring lossless transmission of pressure signals while meeting clinical aseptic requirements. This design avoids the waste of precision intelligent components by discarding the entire dressing, significantly reducing clinical usage costs while balancing safety and economy.

[0017] 3. The interactive platform of this solution has functions such as registration and login, device group management, and full data storage: the intelligent processor completes the attribution marking through a unique identification code, and medical staff can manage devices by department and ward group and configure parameters in batches; the platform can also store data such as extravasation detection electrical signals, pressure change curves, and early warning records, and supports retrieval and export by device identifier, time, and risk level. This not only realizes unified authorization management of devices under the same attribution entity, reducing the burden of manual recording and inspection for nursing staff, but also provides traceable data support for the statistical analysis of clinical infusion extravasation events and the improvement of nursing quality.

[0018] In summary, this solution addresses the core pain points of traditional extravasation detection, such as delayed detection, high cost, and disorganized management. Through collaborative innovation combining real-time pressure sensor detection, intelligent module reuse design, and integrated management via an interactive platform, it achieves fully automated prevention and control of extravasation from early detection to tiered intervention, ensuring medication safety for special patients. Furthermore, component reuse reduces clinical costs, while data management improves nursing efficiency and quality. This constructs a comprehensive intravenous infusion extravasation prevention and control system that balances safety, economy, and management, effectively filling the functional gaps of traditional dressings and single pressure detection devices. Attached Figure Description

[0019] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this application, illustrate exemplary embodiments of the invention and, together with their description, serve to explain the invention and do not constitute an undue limitation thereof. In the drawings: Figure 1This is a schematic diagram of the overall appearance of the device proposed in this invention; Figure 2 This is a bottom view of the adhesive tape structure proposed in this invention; Figure 3 This is a top view of the adhesive tape structure proposed in this invention; Figure 4 This is a bottom view of the insulating shell structure proposed in this invention; Figure 5 This is a schematic diagram of the overall cross-sectional structure of the device proposed in this invention; Figure 6 This is a schematic diagram of the cross-sectional structure of the insulating shell proposed in this invention; Figure 7 The present invention proposes Figure 5 Enlarged schematic diagram of the structure at part A in the middle; Figure 8 This is a block diagram showing the overall module connection of the device proposed in this invention; Figure 9 This is a flowchart illustrating the risk classification and control measures for extravasation proposed in this invention.

[0020] The numbers in the diagram are: 1. Adhesive tape; 2. Cleanroom tape; 3. Sterile dressing; 4. Insulating shell; 5. Stimulus pin; 6. Pressure sensor; 7. Intelligent processor; 8. Ring-shaped energy storage battery; 9. Damping sleeve; 10. Assembly / disassembly slot. Detailed Implementation

[0021] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0022] See Figures 1 to 9 The intravenous infusion extravasation detection device based on a pressure sensor in this invention includes an adhesive tape 1 and a dust-free tape 2 attached to the lower end of the adhesive tape 1. The adhesive tape 1 ensures that the sterile dressing 3 can adhere to the infusion needle hole, preventing the pressure sensor 6 from failing to detect pressure changes at the infusion needle hole due to insufficient coverage. The sterile dressing 3, which adheres to the infusion needle hole, is installed at the center of the bottom surface of the adhesive tape 1. This sterile dressing 3 differs from traditional dressings in that it is made of non-absorbent material. When water leaks at the infusion needle, the liquid will squeeze the sterile dressing 3 upwards and deform it, thereby triggering the pressure sensor 6 to detect the leak. The sterile dressing 3 also has a built-in magnesium sulfate storage chamber for storing magnesium sulfate solution, and a slow-release switch is provided on the magnesium sulfate storage chamber. The sterile dressing 3 has a sensing mechanism installed inside for sensing the pressure at the infusion needle hole, and an insulating shell 4 is provided at the center of the top surface of the adhesive tape 1. A detachable intelligent processing module is installed inside the insulating shell 4.

[0023] The sensing mechanism is used to collect the physical pressure signal at the infusion puncture site; The intelligent processing module receives the physical pressure signal from the infusion puncture site collected by the sensing mechanism, and converts the physical pressure signal into an electrical signal, which is denoted as... The original electrical signal is then preliminarily filtered using an RC low-pass filter algorithm, and simultaneously amplified by an operational amplifier to finally generate the extravasation detection electrical signal. The formula for the RC low-pass filter algorithm is as follows: The operational amplifier amplification formula is: ; In the above formula: Here, R is the filtered electrical signal, C is the filter circuit resistance, t is the filter circuit capacitance, and τ is the signal acquisition time. A is the initial voltage of the filter circuit, and A is the amplification factor of the operational amplifier (values ​​range from 10 to 50 times, adapted to the output sensitivity of pressure sensor 6, preferably 20 times). Let τ be the original electrical signal at time τ; This invention also includes an interactive platform independently set up with the device; the intelligent processing module and the interactive platform establish a two-way communication connection through Bluetooth and wireless radio frequency dual-mode signal transmission; the interactive platform includes functions such as extravasation detection electrical signal processing, infusion puncture site status observation, pressure data historical change trend prediction, extravasation early warning, registration and login, authorized mobile terminal management, device registration and binding, and extravasation detection signal data storage. The intelligent processor 7 supports registration operations. The interactive platform marks the registered intelligent processor 7 and realizes unified authorization management of all devices under the same owner. Only authorized mobile terminals can log in to the interactive platform and perform related functions.

[0024] Specifically, the sensing mechanism includes a pressure sensor 6 embedded inside the sterile dressing 3, two conductive pins 5 fixed on the top surface of the sterile dressing 3, and an insulating protective sleeve sleeved on the outside of the pins 5. The insulating protective sleeve is coaxially arranged with the pins 5 and a gap is left between them. The pressure sensor 6 is the core component of the sensing mechanism for collecting pressure physical signals, and the pressure physical signals it collects are transmitted to the intelligent processing module through the pins 5.

[0025] Specifically, the positive terminal of the pressure sensor 6 is electrically connected to one of the contact pins 5, and the negative terminal of the pressure sensor 6 is electrically connected to the other contact pin 5; the top of the contact pin 5 and the top of the insulating protective sleeve both penetrate the adhesive tape 1 and extend to the upper surface of the adhesive tape 1, and the top of the contact pin 5 protrudes from the top of the insulating protective sleeve.

[0026] Specifically, the intelligent processing module also includes an intelligent processor 7 and a ring-shaped energy storage battery 8. The intelligent processor 7 is located on one side of the ring-shaped energy storage battery 8. The intelligent processor 7 integrates a Bluetooth communication unit for communicating with the interactive platform, a wireless radio frequency transceiver unit, and a power management unit to ensure signal processing. The power management unit integrates overvoltage protection (threshold 4.2V), overcurrent protection (threshold 100mA), and low battery warning (triggered when the remaining battery power is ≤10%) functions.

[0027] Specifically, the insulating housing 4 has symmetrical disassembly and assembly slots 10 on both sides for easy disassembly and assembly. The bottom of the insulating housing 4 has two mounting slots that are compatible with the contact pin 5 and the insulating protective sleeve. Each mounting slot is fixed with a damping sleeve 9. After the contact pin 5 and the insulating protective sleeve are inserted into the damping sleeve 9, the circuit between the sensing mechanism and the intelligent processing module is closed. The damping sleeve 9 and the contact pin 5 are interference-fitted to ensure connection stability.

[0028] Specifically, the sterile dressing 3 is a non-absorbent medical sterile elastic dressing made of medical polyurethane film. The side of the sterile dressing 3 that adheres to the skin is coated with low-sensitivity medical pressure-sensitive adhesive. The shape of the sterile dressing 3 is adapted to the infusion puncture site to ensure the accuracy of pressure physical signal acquisition.

[0029] Specifically, the registration and login functions of the interactive platform include processor registration and authorized mobile terminal registration. When registering, the processor sends a unique identification code to the interactive platform. The unique identification code consists of an 8-digit production batch number and an 8-digit device serial number. The interactive platform verifies the code by comparing it with the pre-stored production batch database. After successful verification, the platform assigns an ownership identifier to the intelligent processor 7 and completes the ownership marking. Authorized mobile terminals log in using account password, verification code, or biometric verification. Unregistered and unauthorized mobile terminals are prohibited from accessing the interactive platform and related device data.

[0030] Specifically, the interactive platform enables unified authorization management of all devices under the same ownership entity for the intelligent processor 7 that has completed the ownership marking. This includes adding devices (by scanning the unique identification code QR code of the intelligent processor 7), unbinding (requiring the input of the ownership entity administrator password or biometric verification), status monitoring (real-time display of device power supply status, signal strength, and pressure acquisition status), and permission allocation (divided into three levels of permissions according to roles: "administrator", "caregiver", and "viewer"). The interactive platform supports grouping and managing devices under the same ownership entity by department, ward, or patient type. Each group can contain up to 100 devices and supports batch configuration of parameters within the group (such as pressure sampling frequency and early warning threshold).

[0031] Specifically, the process of processing the electrical signals for extravasation detection in the interactive platform is as follows, and the connection between each step is achieved through timing control logic: The pressure sensor 6 of the sensing mechanism collects the physical pressure signal of the infusion puncture site in real time and transmits it to the intelligent processing module. The intelligent processing module converts the physical pressure signal into an electrical signal, which is then filtered and amplified to generate an external leakage detection electrical signal, which is then transmitted to the interactive platform. The interactive platform performs signal noise reduction, feature extraction, and pressure value conversion on the received extravasation detection electrical signals. Specifically, a wavelet threshold noise reduction algorithm is used to process the received extravasation detection electrical signal. For noise reduction, a db4 wavelet basis is selected, and the decomposition layer is 3. A soft thresholding function is used, with the following formula: ;in: These are the wavelet coefficients after noise reduction. for The original wavelet coefficients after wavelet decomposition For noise reduction threshold ( , The noise standard deviation is estimated from the high-frequency coefficients of wavelet decomposition; N is... The number of sampling points corresponds to the sampling frequency of the pressure sensor 6 (e.g., N = 60 points / minute when the sampling frequency is 1Hz). After noise reduction, a clean electrical signal is obtained by inverse wavelet transform reconstruction. ; Will The actual subcutaneous pressure value P at the infusion puncture site is converted using a linear fitting formula, which is: ; Where: P is the actual subcutaneous pressure value, k is the sensitivity coefficient of pressure sensor 6, provided by the sensor's factory calibration data, and b is the zero-point offset of pressure sensor 6, obtained by the interactive platform through the "zero-point calibration" function before the device's first use—the calibration method is: attach the sterile dressing to the pressure-free plane (i.e., pressure value of 0 kPa) of the standard pressure testing platform, and collect data within a predetermined time. average value Substitute Calculated ; Pressure change rate calculation: The pressure change rate v is calculated based on two consecutively sampled pressure values. The formula is: Where: v is the rate of pressure change (unit: kPa / min). The pressure value at the current time t. The pressure value at the previous sampling time t−Δt, where Δt is the sampling time interval; Extravasation risk level determination: A two-level determination logic is established by combining P and v, and a three-level extravasation determination range group is preset (where, The lower limit threshold of pressure for low-risk extravasation. The upper limit of pressure for low-risk extravasation (and simultaneously the lower limit of pressure for medium-risk extravasation) ), This is the upper limit threshold for pressure in medium-risk extravasation (and simultaneously the lower limit threshold for pressure in high-risk extravasation). ); This is the upper limit threshold for the rate of low-risk extravasation (and simultaneously the lower limit threshold for the rate of medium-risk extravasation). ), This is the upper limit threshold for the rate of medium-risk extravasation (and simultaneously the lower limit threshold for the rate of high-risk extravasation). (The above thresholds are all preset judgment values ​​based on clinical infusion extravasation characteristics). exist and At that time, it was determined to be a low-risk infiltration. exist and ,or and At that time, the risk of infiltration was determined to be medium. exist ,or and At that time, a high-risk leakage was identified; If the risk of infiltration is determined to be low, the interactive platform will only send text warning information to authorized mobile terminals and simultaneously store P, v and timestamp t in the time series database. If the extravasation is determined to be of medium risk, the interactive platform sends an audible and visual warning to the authorized mobile terminal and simultaneously sends a closing signal to the control valve of the pre-connected infusion tubing solenoid valve to close the infusion pathway. It also activates the slow-release switch of the magnesium sulfate storage chamber built into the sterile dressing 3, allowing the magnesium sulfate solution to penetrate into the skin surface of the puncture site for wet compress. If the extravasation is determined to be of high risk, in addition to performing the corresponding operations for medium-risk extravasation, the interactive platform sends an emergency support reminder to the nursing management terminal of the responsible entity, along with the patient's identity information, puncture site, and real-time pressure curve data. After extravasation is treated, nursing staff send a completion command to the interactive platform via an authorized mobile terminal, and the platform records the treatment time. (( To process the completion timestamp, The system uses the warning trigger timestamp and processing method (such as "magnesium sulfate wet compress + re-puncture") to terminate the warning and send a recovery detection command to the intelligent processor 7, and restore the intelligent processing module to the real-time detection state.

[0032] Specifically, the data storage function of the extravasation detection signal of the interactive platform can store all extravasation detection electrical signals, converted pressure values, pressure change curves, early warning records, and prediction result reports transmitted by the intelligent processing module. It also supports the retrieval, filtering, and export of stored data by device unique identification code, time, owner, and risk level.

[0033] Specifically, the interactive platform can set tiered permissions for authorized mobile terminals, including basic permissions that only allow data viewing and alarm receiving, intermediate permissions that allow device management and data export, and advanced permissions that allow platform configuration and permission allocation.

[0034] Specifically, the interactive platform's historical trend prediction function for stress data is based on exponential smoothing and includes the following steps: Data preprocessing: Extract historical stress data stored in the time-series database of the interactive platform to form a stress value sequence. (n is the number of historical data points, at least 30), timestamp sequence The sample set is divided into time windows of W=30 sampling points; Predictive Model Construction: A predictive model is constructed using the first exponential smoothing method, with the following formula: ,in: Here is the predicted pressure value at time t+T, where T is the prediction duration. For smoothing coefficients, The actual pressure value at the current time t. The predicted pressure value at time t; the initial predicted value. ; Prediction Error Assessment: The mean squared error (MSE) is used to assess prediction accuracy, using the following formula: Where: m is the number of error evaluation samples (at least 10). The actual pressure value at time t+i. The predicted pressure value at time t+i; the model prediction result is valid when the calculated mean square error (MSE) does not exceed the preset effective error threshold for model prediction; where the effective error threshold for model prediction is a preset error judgment value based on historical prediction accuracy and clinical extravasation risk assessment requirements. Trend warning triggered: If The corresponding risk level is higher than the current actual risk level, or If the risk level exceeds the preset high-risk threshold, the interactive platform will send a trend warning to the authorized mobile terminal in advance (format: "Patient [Name] (Bed Number [X]) puncture site pressure is expected to rise to [T] after [T] [X]"). [kPa, risk level expected to rise to [predicted level], early intervention recommended], simultaneously pushing out the predicted pressure curve ( (To the interactive platform interface)

[0035] Specifically, the extravasation detection signal data storage function of the interactive platform adopts a "MySQL + InfluxDB" combined storage architecture: MySQL database: Stores structured data, including device information table (fields: UUID, OrgID, production batch, calibration date, last maintenance time), patient information table (fields: patient ID, name, bed number, hospital number, puncture site, infusion order number), and warning record table (fields: warning ID, UUID, patient ID, warning level, trigger time, processing time, processing method, processing personnel ID). InfluxDB database: stores time-series data, including pressure value tables, pressure change rate tables, and extravasation detection electrical signal tables; The interactive platform supports multi-condition retrieval by UUID, time range, OrgID, and risk level, and supports data export to Excel, CSV, or PDF formats (PDF includes data tables and stress change curves / charts).

[0036] This device achieves real-time detection and rapid intervention of intravenous extravasation through a complete process consisting of hardware-coordinated power supply, pressure signal acquisition, signal processing and transmission, platform-level response, and closed-loop management reuse. The specific principle is as follows: Medical staff first align the damping sleeve 9 at the bottom of the insulating shell 4 with the conductive contact pin 5 exposed at the top of the adhesive tape 1 and the insulating protective sleeve. They then gently press the insulating shell 4 to ensure a tight fit between the contact pin 5 and the conductive inner sleeve of the damping sleeve 9, and to ensure the insulating protective sleeve and the insulating outer sleeve of the damping sleeve 9 are properly fitted, thus completing the electrical closure between the sensing mechanism and the intelligent processing module. At this time, the ring-shaped energy storage battery 8 within the intelligent processing module supplies power to the intelligent processor 7 and the pressure sensor 6 through the power management unit. The device enters standby detection mode, and the power management unit simultaneously activates overvoltage and overcurrent protection to ensure power supply safety.

[0037] Medical staff peel off the cleanroom tape 2 from the bottom of the adhesive tape 1 and align the sterile dressing 3 on the bottom of the adhesive tape 1 with the patient's infusion puncture site. A tight fit is achieved through the low-sensitivity medical pressure-sensitive adhesive on the dressing surface. The sterile dressing 3 uses a non-absorbent medical polyurethane film to prevent pressure loss due to extravasation. When extravasation occurs, the leaked fluid accumulates under the skin and compresses the sterile dressing 3, causing a slight deformation. This deformation directly acts on the pressure sensor 6 inside the dressing, triggering the sensor to collect the pressure physical signal at the puncture site in real time. The signal is transmitted to the intelligent processing module through two conductive pins 5 connected to the positive and negative terminals of the sensor, respectively.

[0038] After receiving the physical pressure signal transmitted by the pressure sensor 6, the intelligent processor 7 first converts it into a raw electrical signal, then filters out environmental electromagnetic interference through a built-in filtering algorithm, and then amplifies the weak signal through an operational amplifier to finally generate a stable external leakage detection electrical signal, laying the foundation for subsequent transmission and processing.

[0039] The intelligent processor 7 transmits extravasation detection electrical signals to an independent interactive platform via an integrated Bluetooth communication unit and a wireless RF transceiver unit in a dual-mode signal transmission manner. This dual-mode design avoids signal loss due to a single communication link interruption. Upon receiving the signal, the interactive platform first purifies it using a noise reduction algorithm, then converts the purified electrical signal into the actual pressure value at the puncture site. Simultaneously, it calculates the pressure change rate and, combined with a preset three-level risk assessment standard, determines the extravasation risk level as low, medium, or high based on the combination of pressure value and pressure change rate.

[0040] The interactive platform triggers corresponding intervention operations based on the risk level: at low risk, it only sends a text warning to the authorized mobile terminal and stores relevant data simultaneously; at medium risk, it sends an audible and visual warning to the authorized mobile terminal, sends a closing signal to the electromagnetic control valve of the infusion line, and sends an instruction to the intelligent processor 7 to activate the slow-release switch of the magnesium sulfate storage chamber built into the sterile dressing 3, allowing the magnesium sulfate solution to penetrate into the puncture site for wet dressing; at high risk, in addition to the medium-risk operation, it sends an emergency support reminder to the nursing management terminal, along with the patient's identity information and real-time status data of the puncture site.

[0041] After extravasation is treated, nursing staff send a completion instruction to the interactive platform via an authorized mobile terminal. The platform records the treatment time and method, terminates the alert, and sends a resumption instruction to the intelligent processor 7, restoring the device to real-time data acquisition. After the infusion is completed, medical staff remove the intelligent processing module via the disassembly slots 10 on both sides of the insulating shell 4. After disinfection, the module can be reused. Disposable components such as adhesive tape 1 and sterile dressing 3 are disposed of according to medical waste regulations.

[0042] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A pressure sensor-based intravenous infusion extravasation detection device, comprising an adhesive tape (1) and a dust-free tape (2) attached to the lower end of the adhesive tape (1), characterized in that: The adhesive tape (1) has a sterile dressing (3) installed at the center of its bottom surface to fit the infusion needle hole. The sterile dressing (3) also has a magnesium sulfate storage chamber inside, which is used to store magnesium sulfate solution. The magnesium sulfate storage chamber is equipped with a slow-release switch. The sterile dressing (3) has a sensing mechanism installed inside to sense the pressure at the infusion needle hole. The adhesive tape (1) has an insulating shell (4) at the center of its top surface. The insulating shell (4) has a detachable intelligent processing module installed inside. The sensing mechanism is used to collect the physical pressure signal at the infusion puncture site; The intelligent processing module is used to receive the pressure physical signal of the infusion puncture site collected by the sensing mechanism, convert the pressure physical signal into an electrical signal, and generate an extravasation detection electrical signal after preliminary processing such as filtering and amplification of the electrical signal. It also includes an interactive platform independently set up with the device; the intelligent processing module and the interactive platform establish a two-way communication connection through Bluetooth and wireless radio frequency dual-mode signal transmission; the interactive platform includes functions such as extravasation detection electrical signal processing, infusion puncture site status observation, pressure data historical change trend prediction, extravasation early warning, registration and login, authorized mobile terminal management, device registration and binding, and extravasation detection signal data storage. The intelligent processor supports registration operations, and the interactive platform marks the registered intelligent processors and realizes unified authorization management of all devices under the same owner. Only authorized mobile terminals can log in to the interactive platform and perform related functions.

2. The intravenous infusion extravasation detection device based on a pressure sensor according to claim 1, characterized in that: The sensing mechanism includes a pressure sensor (6) embedded inside the sterile dressing (3), two conductive pins (5) fixed on the top surface of the sterile dressing (3), and an insulating protective sleeve sleeved on the outside of the pins (5). The insulating protective sleeve is coaxially arranged with the pins (5) and there is a gap between them. The pressure sensor (6) is the core component of the sensing mechanism for collecting pressure physical signals. The pressure physical signals collected by the sensor are transmitted to the intelligent processing module through the pins (5).

3. The intravenous extravasation detection device based on a pressure sensor according to claim 2, characterized in that: The positive terminal of the pressure sensor (6) is electrically connected to one of the contact pins (5), and the negative terminal of the pressure sensor (6) is electrically connected to the other contact pin (5); the top of the contact pin (5) and the top of the insulating protective sleeve both penetrate the adhesive tape (1) and extend to the upper surface of the adhesive tape (1), and the top of the contact pin (5) protrudes from the top of the insulating protective sleeve.

4. The intravenous infusion extravasation detection device based on a pressure sensor according to claim 1, characterized in that: The intelligent processing module also includes an intelligent processor (7) and a ring-shaped energy storage battery (8). The intelligent processor (7) is located on one side of the ring-shaped energy storage battery (8). The intelligent processor (7) integrates a Bluetooth communication unit for communicating with the interactive platform, a wireless radio frequency transceiver unit, and a power management unit to ensure signal processing.

5. The intravenous infusion extravasation detection device based on a pressure sensor according to claim 1, characterized in that: The insulating shell (4) has symmetrical disassembly and assembly slots (10) on both sides for easy disassembly and assembly. The bottom of the insulating shell (4) has two mounting slots that are compatible with the stylus (5) and the insulating protective sleeve. Each mounting slot is fixedly fitted with a damping sleeve (9). After the stylus (5) and the insulating protective sleeve are inserted into the damping sleeve (9), the circuit between the sensing mechanism and the intelligent processing module is closed. The damping sleeve (9) and the stylus (5) are interference fit.

6. The intravenous infusion extravasation detection device based on a pressure sensor according to claim 1, characterized in that: The sterile dressing (3) is a non-absorbent medical sterile elastic dressing made of medical polyurethane film. The side of the sterile dressing (3) that is in contact with the skin is coated with low-sensitivity medical pressure-sensitive adhesive. The shape of the sterile dressing (3) is adapted to the infusion puncture site.

7. The intravenous infusion extravasation detection device based on a pressure sensor according to claim 4, characterized in that: The registration and login functions of the interactive platform include processor registration and authorized mobile terminal registration. When the processor registers, it sends a unique identification code to the interactive platform. After the interactive platform verifies the code, it completes the attribution marking. The authorized mobile terminal completes the login through account password, verification code or biometric verification. Unregistered and unauthorized mobile terminals are prohibited from accessing the interactive platform and related data.

8. The intravenous infusion extravasation detection device based on a pressure sensor according to claim 7, characterized in that: The interactive platform enables unified authorization management of all devices under the same ownership entity for intelligent processors that have completed ownership marking, including operations such as adding, unbinding, status monitoring, and permission allocation of devices. The interactive platform also supports group management of devices under the same ownership entity.

9. The intravenous infusion extravasation detection device based on a pressure sensor according to claim 1, characterized in that: The specific process of processing the electrical signals for extravasation detection in the interactive platform is as follows: The pressure sensor (6) of the sensing mechanism collects the pressure physical signal of the infusion puncture site in real time and transmits it to the intelligent processing module; The intelligent processing module converts the physical pressure signal into an electrical signal, which is then filtered and amplified to generate an external leakage detection electrical signal, which is then transmitted to the interactive platform. The interactive platform performs signal noise reduction, feature extraction, and pressure value conversion on the received extravasation detection electrical signals. It then compares the conversion results with the preset three-level extravasation judgment range group to determine the extravasation risk level. The three-level extravasation determination group includes low-risk extravasation, medium-risk extravasation, and high-risk extravasation ranges; Perform the corresponding operation based on the leakage determination result; After extravasation is treated, nursing staff send a completion instruction to the interactive platform via an authorized mobile terminal. The interactive platform records the treatment duration and method, terminates the warning, and restores the intelligent processing module to real-time monitoring status.

10. The intravenous infusion extravasation detection device based on a pressure sensor according to claim 1, characterized in that: The data storage function of the extravasation detection signal of the interactive platform can store all extravasation detection electrical signals, converted pressure values, pressure change curves, early warning records, and prediction result reports transmitted by the intelligent processing module. It also supports the retrieval, filtering, and export of stored data by device unique identification code, time, owner, and risk level.

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