Monitoring, alarming and liquid stopping device based on infusion leakage

Abstract

The invention relates to the technical field of medical instruments, in particular to a monitoring, alarming and liquid stopping device based on infusion leakage, which comprises a wearing bracelet, the wearing bracelet comprises a disposable wrist strap part, a digital display screen and an attaching piece, a connecting shell is arranged at the bottom of the digital display screen, and a central controller is integrated in the connecting shell; an attaching layer assembly is arranged at the bottom of the attaching piece, and a near-infrared collecting assembly and a skin surface temperature collecting assembly are arranged at the bottom of the attaching layer assembly; the connecting shell is connected with an electric control liquid stopping clamp through a wire, a hydraulic collecting assembly is arranged on the electric control liquid stopping clamp, a seepage limiting assembly is further arranged at the bottom of the attaching piece, the central controller is in signal connection with an early warning platform, and the early warning platform comprises a nurse station total end and a plurality of individual ends. By integrating the functions of multi-dimensional infusion leakage monitoring, intelligent risk grading evaluation, early warning signal grading pushing and automatic liquid stopping and leakage limiting, the defects of one-way early warning response delay, single index monitoring deviation and untimely intervention in the prior art are overcome.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a device for monitoring, alarming, and stopping infusion leakage. Background Technology

[0002] Infusion leakage often occurs due to improper puncture procedures (such as the needle bevel not being fully inserted into the blood vessel or not being securely fixed), poor vascular conditions in patients (such as poor vascular elasticity in the elderly and thin and fragile blood vessels in infants and young children), irritating or hypertonic drugs being infused (such as chemotherapy drugs and mannitol), and excessive limb movement during infusion. Its harms include local tissue swelling, pain, and redness. In severe cases, it can lead to phlebitis, skin ulcers, tissue necrosis, and even affect limb function. If irritating drugs seep into the subcutaneous tissue, they may also cause allergic or toxic reactions.

[0003] To reduce the harm to patients from intravenous infusion leakage, existing technologies, such as the SmartTouch infrared monitoring system, mainly consist of two core components: a SmartTouch intelligent touch sensor (which emits light signals through two near-infrared optical sensor emitters, and the detector receives the light signals reflected back from the subcutaneous tissue, measuring the optical properties and changes in diffuse reflectance of the tissue) and an ivWatch monitor. The SmartTouch sensor is a sterile and adhesive device that can be attached to the skin or a transparent dressing near the insertion point of the intravenous infusion catheter. Under normal conditions, the scattering structures (such as cells, collagen fibers, etc.) and absorbing structures (such as hemoglobin, melanin, etc.) within the tissue affect the reflection of light. When infusion leakage occurs into the subcutaneous tissue, the distribution of these structures changes, resulting in significant differences in the diffuse reflectance signal. The sensor transmits these changes to the ivWatch monitor, which analyzes them using its proprietary algorithm to determine whether leakage has occurred. If a potential leakage is detected, a yellow alarm is issued; if a high probability of leakage is detected, a red alarm is issued. The ivWatch monitor also generates visual and auditory notifications, allowing the patient to inform medical staff to stop the infusion immediately and to examine and treat the infusion site.

[0004] However, in actual medical scenarios, especially in large hospitals, the imbalance between the number of patients and the allocation of nursing staff is common. The existing infusion leakage monitoring mode, which relies on one-way early warning signal transmission from the patient to the nurse station, is difficult to ensure timely intervention of leakage risks due to the frequent temporary staff shortages at the nurse station. Given the serious clinical consequences of infusion leakage, its high degree of harm places strict requirements on the timeliness of response. Therefore, there is an urgent need to build an intelligent device that integrates infusion leakage monitoring, hierarchical alarm, and signal push. By distributing early warning signals to individual nurses, it can ensure that medical staff can receive early warning information anytime and anywhere and respond quickly, thereby effectively reducing the adverse clinical impact of leakage. Summary of the Invention

[0005] To address the aforementioned issues, this invention provides a monitoring, alarm, and stop-leakage device based on infusion leakage. By integrating multi-dimensional infusion leakage monitoring, intelligent risk classification assessment, graded push of early warning signals, and automatic stop-leakage and leakage-limiting functions, it overcomes the shortcomings of existing technologies, such as delayed one-way early warning response, bias in monitoring single indicators, and untimely intervention.

[0006] To achieve the above objectives, the technical solution of the present invention is as follows: a monitoring, alarm and stop-flow device based on infusion leakage, including a wristband, the wristband including a disposable wristband, a digital display screen and an attachment piece, the attachment piece having an elliptical needle groove, the bottom of the digital display screen being fixedly connected to a connecting shell that is detachably connected to the disposable wristband, and a central controller electrically connected to the digital display screen being integrated inside the connecting shell.

[0007] The bottom of the patch is provided with an adhesion layer assembly for adhering to the skin surface of the patient's infusion area. The bottom of the adhesion layer assembly is provided with a near-infrared acquisition assembly for collecting the distribution changes of the subcutaneous tissue structure in the patient's infusion area by emitting and receiving near-infrared light. The bottom surface of the adhesion layer assembly is also provided with several skin surface temperature acquisition components for collecting the skin surface temperature of the patient's infusion area.

[0008] The outer casing is connected to an electrically controlled stop clamp fitted onto the disposable infusion set. The electrically controlled stop clamp is equipped with a hydraulic acquisition component for collecting the infusion pressure of the liquid inside the disposable infusion set. The hydraulic acquisition component, temperature acquisition component, and near-infrared acquisition component are all electrically connected to the central controller. The central controller receives and comprehensively analyzes skin surface temperature data, subcutaneous tissue structure distribution changes, and infusion pressure values ​​in real time to dynamically assess and predict the risk of infusion leakage.

[0009] The bottom of the patch is also equipped with a seepage limiting component that is dynamically driven according to the risk of infusion leakage. Both the seepage limiting component and the electrically controlled stop clamp are electrically connected to the central controller.

[0010] The central controller is also connected to an early warning platform, which includes a central terminal at the nurse station and several individual terminals.

[0011] The nurse station central terminal is used to receive the infusion leakage risk level sent by the central controller in real time, automatically associate it with the corresponding patient's bed number information, and at the same time, the nurse station central terminal transmits the patient's bed number and warning signal to several individual terminals according to the preset risk level triggering rules, and synchronously stores the infusion leakage risk level data and historical records of all patients.

[0012] Each individual terminal is used to receive patient bed numbers and warning signals transmitted from the central nursing station in real time. When a patient bed number and warning signal are received, vibration or audio-visual alerts are immediately triggered.

[0013] The technical principle of the above solution is as follows: This solution uses a wristband as the carrier, which is divided into three parts: a disposable wristband, a digital display screen, and an adhesive patch. The wristband is worn to monitor, warn of, and stop infusion leakage. An adhesive layer component located below the adhesive patch adheres to the patient's skin in the infusion area. Near-infrared and skin surface temperature acquisition components collect data on subcutaneous tissue structure changes and skin temperature, respectively. An electrically controlled stop-flow clamp is designed for adjustment, achieving non-invasive contact with the disposable infusion set. A hydraulic acquisition component collects infusion pressure values. The central controller receives and comprehensively analyzes skin surface temperature data, subcutaneous tissue structure distribution changes, and infusion pressure values ​​in real time to dynamically assess the risk of infusion leakage. When a risk is detected, the central controller drives the permeability limiting component to restrict leakage spread and automatically stops the leakage through the electrically controlled stop-flow clamp. Simultaneously, a risk level signal is transmitted to the early warning platform. The nurse station's central terminal receives the signal, associates it with the patient's bed number, and pushes an early warning signal to the individual patient's terminal according to preset rules, triggering an alert.

[0014] The above approach has the following beneficial effects:

[0015] 1. This solution overcomes the shortcomings of existing technologies that rely on one-way early warning from the patient to the nurse station and the delay in intervention caused by temporary staff shortages at the nurse station. By using an early warning platform to push signals to individuals in a tiered manner, it ensures that individual medical staff can receive and respond quickly anytime and anywhere, thus solving the problem of delayed response to one-way early warnings.

[0016] 2. This solution addresses the stringent requirements for response speed due to the high hazards of intravenous infusion leakage. It integrates leakage monitoring and alarm functions through a central controller combining near-infrared, skin temperature, and hydraulic sensing components. Furthermore, it integrates leakage control via a liquid limiting component and an electrically controlled liquid clamp, minimizing the risks of drug extravasation.

[0017] 3. This plan uses multi-dimensional data, including skin surface temperature data, subcutaneous tissue structure distribution changes, and infusion pressure, to comprehensively assess the risk of infusion leakage, avoiding the bias of monitoring a single indicator and reducing the probability of misjudgment or missed judgment.

[0018] Furthermore, the central controller dynamically assesses and predicts the risk of infusion leakage in the following specific ways:

[0019] The central controller uses a convolutional neural network model to extract features and rank the importance of skin surface temperature data, subcutaneous tissue structure distribution changes and infusion pressure values, respectively. It assigns differentiated leakage reference weights to the three types of monitoring data. Then, it performs weighted fusion calculations on the real-time monitoring values ​​of each data with the corresponding weights, and combines the preset normal physiological and infusion parameter threshold ranges to obtain a quantitative infusion leakage risk value.

[0020] The infusion leakage risk level is then defined based on the infusion leakage risk value. The infusion leakage risk level includes normal state, leakage warning state and leakage emergency state. The infusion leakage risk level is transmitted to the nurse station terminal in real time as a standardized output signal.

[0021] Beneficial effects: This design uses a convolutional neural network model to achieve intelligent analysis and risk classification of skin temperature, subcutaneous structure changes and infusion pressure data, improves the accuracy and scientific nature of infusion leakage assessment, provides precise basis for the graded response of the early warning platform, and reduces unnecessary early warning interference.

[0022] Furthermore, a pumping component is fixedly connected inside the connecting housing, and the adhesive layer assembly includes an adhesive bladder layer fixedly connected to the bottom of the adhesive sheet. The adhesive bladder layer corresponds to the shape of the adhesive sheet, and the adhesive bladder layer is connected to the output end of the pumping component.

[0023] Beneficial effects: By injecting gas into the attachment layer through the pump, the attachment expands and adheres to the patient's skin, avoiding the skin irritation and damage caused by the traditional method of attaching a patch-like monitoring object. This ensures stable adhesion between the near-infrared acquisition component and the skin temperature component, improves the reliability of monitoring data, simplifies the operation process, and enhances patient comfort and compliance.

[0024] Furthermore, the near-infrared acquisition component includes symmetrical SmartTouch sensors, all of which are fixedly connected to the bottom surface of the attached capsule layer.

[0025] Beneficial effects: The symmetrically arranged SmartTouch sensors are fixed on the bottom surface of the adhering capsule layer. By emitting and receiving near-infrared light, they collect information on changes in the distribution of subcutaneous tissue structures, ensuring that the SmartTouch sensor's collection range covers the infusion area. This improves the comprehensiveness and accuracy of monitoring subcutaneous structural changes and provides key data support for leakage risk assessment.

[0026] Furthermore, the skin surface temperature acquisition component includes several temperature sensors evenly distributed along the circumference of the adhesive patch, and all temperature sensors are fixedly connected to the adhesive capsule layer.

[0027] Beneficial effects: By collecting skin temperature data of the infusion area through several circumferentially evenly distributed temperature sensors, the temperature gradient difference of the patient's infusion area is captured through multi-point acquisition, which helps to identify temperature abnormalities in the leakage area. Cross-validation with near-infrared data reduces the bias of single indicator monitoring and improves the accuracy of leakage detection.

[0028] Furthermore, the electrically controlled liquid stop clamp includes actuators arranged symmetrically and in opposite directions, with pressure pipe blocks fixedly connected to the output ends of both actuators.

[0029] Beneficial effects: The symmetrically arranged actuators drive the pressure block to move, and the actuator action causes the pressure block to squeeze the infusion set tubing, ensuring uniform pressure on the infusion tubing, achieving rapid and reliable automatic liquid stoppage, preventing the continuous outflow of leaked medicine, and reducing the risk of hazard spread.

[0030] Furthermore, the hydraulic acquisition component includes several pressure sensors embedded in one side wall of the corresponding pressure pipe block, and both the pressure sensors and the actuators are electrically connected to the central controller;

[0031] The central controller uses the preset pressure threshold of the pressure sensor as a reference to control the actuator to drive the pressure block to pre-pressurize the disposable infusion set. During the infusion process, the controller continuously feeds back the dynamic radial pressure data of the disposable infusion set tube wall through several pressure sensors, extracts the radial pressure change curve, and converts the radial pressure change curve into the corresponding infusion pressure value.

[0032] Beneficial effects: By collecting radial pressure data of the infusion set tubing wall through pressure sensors, the central controller pre-sets the pressure threshold and regulates the actuator to pre-pressurize the infusion tubing, extracts the pressure change curve and converts it into infusion pressure value, realizing non-invasive infusion pressure monitoring. It accurately captures pressure changes without affecting normal infusion, provides supplementary data for leakage risk assessment, and improves the comprehensiveness of monitoring.

[0033] Furthermore, the permeation limiting component includes several compression airbag rings fixedly connected to the bottom of the attachment sheet. The inner diameter of the compression airbag rings decreases gradually with respect to the center point of the bottom surface of the attachment sheet. The compression airbag rings are fixedly connected to each other and sequentially connected. The output end of the pump is connected to the compression airbag ring with the largest inner diameter.

[0034] Beneficial effects: The design of several interconnected compression airbag rings with decreasing inner diameters ensures that when the pump inflates the largest inner diameter airbag, the gas fills all the airbag rings to form a multi-layered annular compression structure. Combined with the effect of the adhesive layer adhering to the skin surface of the patient's infusion area, it effectively blocks the diffusion of leaked medication to the surrounding area, limits the leakage range, buys time for medical staff to handle the situation, and reduces the risk of tissue damage.

[0035] Furthermore, the connecting ports between several compression airbags are staggered at a high degree.

[0036] Beneficial effects: The staggered design of the connecting ports between the compression airbags allows for more even inflation of each airbag ring, avoiding uneven pressure caused by excessively fast or slow inflation in some areas; it ensures the stability and sealing of the annular compression structure, improves the seepage restriction effect, and prevents leaked medicine from spreading from the compression gap.

[0037] Furthermore, the bottom of the patch is also provided with a disposable silicone sleeve, which covers the bottom of the patch layer and several compression airbags. The disposable silicone sleeve has several acquisition ports corresponding to the temperature sensor and the SmartTouch sensor, respectively.

[0038] Beneficial effects: The design of the disposable silicone sleeve isolates non-disposable components from repeated contact with the skin of different patients, avoiding cross-infection and skin irritation, enhancing fit and pressure seal, meeting clinical infection control standards, and improving safety and leakage control.

[0039] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0040] Figure 1 This is a schematic diagram of the overall structure of the device in an embodiment of the infusion leakage monitoring, alarm and liquid stopping device of the present invention;

[0041] Figure 2 for Figure 1 Enlarged isometric view of the electrically controlled stopcock at point A in the middle;

[0042] Figure 3 for Figure 1 Enlarged isometric view of the connecting shell at point B in the middle;

[0043] Figure 4 This is an isometric view of the bottom arrangement of the attachment plate in an embodiment of the infusion leakage monitoring, alarm and liquid stopping device of the present invention;

[0044] Figure 5 for Figure 4 A partial frontal sectional view of the attached patch;

[0045] Figure 6 This is a schematic diagram illustrating the operation of the information transmission between the central controller and the early warning platform in an embodiment of the infusion leakage monitoring, alarm, and leakage prevention device of the present invention.

[0046] The reference numerals in the accompanying drawings include: 1. Disposable wristband; 2. Digital display screen; 3. Attachment piece; 301. Needle groove; 302. Tube groove; 4. Connecting housing; 5. Electrically controlled liquid stop clamp; 501. Actuator; 502. Tube pressing block; 503. Pressure sensor; 6. Air pump; 7. Central controller; 8. Attachment bladder layer; 9. SmartTouch sensor; 10. Temperature sensor; 11. Compression bladder ring; 12. Disposable silicone sleeve. Detailed Implementation

[0047] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. 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.

[0048] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0049] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0050] The following detailed description illustrates the specific implementation method:

[0051] Example 1:

[0052] This embodiment provides a device for monitoring, alarming, and stopping infusion leakage, specifically as follows: Figure 1 As shown, the device includes a wristband, which comprises a disposable wristband 1 (preferably a disposable waterproof and hypoallergenic wristband, which includes two wristbands, one of which has a limiting post secured, and the other wristband has several adjustment holes), a digital display screen 2 (used to display various data of the patient during infusion), and an adhesive patch 3 (the adhesive patch 3 has a tube inlet groove 302 at its bottom). The adhesive patch 3 has an elliptical needle inlet groove 301. The bottom of the digital display screen 2 is fixedly connected to a connecting housing 4 by bolts. The connecting housing 4 is connected to the wristband by a sliding adjustable strap clip.

[0053] In addition, the four wires connecting the outer casing are connected to an electrically controlled stop clamp 5 that is fitted onto the disposable infusion set, specifically combined with... Figure 1 and Figure 2As shown, the electrically controlled liquid stop clamp 5 includes actuators 501 arranged symmetrically and in opposite directions. The output ends of the two actuators 501 are fused and fixed with pressure tube blocks 502 (the pressure tube blocks 502 are symmetrical so as to be locked onto the disposable infusion set).

[0054] Based on the above structure, this embodiment takes ordinary wrist infusion as an example for explanation: Before the infusion begins, medical staff puts a wristband on the patient and uses a sliding adjustable wristband clip to adjust the connecting shell 4 and digital display screen 2 to the side that is visible to the patient. Then, the attaching piece 3 is positioned by comparing the overlap between the infusion insertion point and the center of the needle groove 301, and the infusion tube is moved into the corresponding tube groove 302. After adjusting the wristband to a level that is neither too tight nor too loose, the symmetrical tube pressing blocks 502 are then fitted onto the tubing of the disposable infusion set according to the gap between the tube pressing blocks 502 to complete the initial wearing of the device proposed in this embodiment.

[0055] After initial wearing, this embodiment has a pump component 6 (preferably a miniature piezoelectric pump, such as the miniature pump built into the dido E50S Pro airbag blood pressure smartwatch) fixedly connected to the connecting housing 4 by bolts. Specifically, in combination with... Figure 1 and Figure 3 As shown, the connecting housing 4 integrates a central controller 7 that is signal-connected to the pumping component 6. Corresponding to the pumping component 6, this embodiment has an attachment layer assembly at the bottom of the attachment patch 3 for attaching to the skin surface of the patient's infusion area. The attachment layer assembly includes an attachment pouch layer 8 that is fused and fixed to the bottom of the attachment patch 3. The attachment pouch layer 8 corresponds to the shape of the attachment patch 3 and is connected to the output end of the pumping component 6. With this design, after the initial wearing is completed, the pumping component 6 is activated by the signal of the central controller 7 to inject gas into the attachment pouch layer 8, causing it to expand and drive the attachment patch 3 and the wristband ring to adhere to the patient's wrist wrist, thus completing the attachment of this device to the patient's wrist.

[0056] The aforementioned inflatable adhesive fixation method, compared to the traditional technique of repeatedly attaching and removing adhesive patches for infusion leakage monitoring, avoids repeated chemical irritation and mechanical damage to the skin from the adhesive, reducing the risk of allergies or breakage in patients with sensitive skin. It also ensures the stability and uniformity of the collection devices used for subsequent infusion leakage collection, reducing the deviation of monitoring data caused by poor adhesion or uneven local pressure. At the same time, it simplifies the operation process for medical staff, saves time and costs, and improves the efficiency of infusion monitoring, as well as the comfort and compliance of patients.

[0057] During intravenous infusion, conventional existing infusion leakage monitoring technologies typically use a single monitoring indicator as the standard for assessing leakage. For example, near-infrared optical monitoring, which has relatively high accuracy, is easily affected by the thickness of fat in the infusion area and the patient's skin color; conductivity monitoring is easily interfered with by the patient's skin dryness or allergic reactions to adhesives, reducing data reliability. Therefore, to improve the accuracy of monitoring, the special feature of this embodiment is:

[0058] Combination Figure 1 and Figure 4 As shown, in this embodiment, a near-infrared acquisition component is provided at the bottom of the adhesive pouch layer 8 for collecting the distribution changes of subcutaneous tissue structure in the patient's infusion area by emitting and receiving near-infrared light. The near-infrared acquisition component includes symmetrical SmartTouch sensors 9, which are all embedded and sewn into the bottom surface of the adhesive pouch layer 8. The bottom of the adhesive pouch layer 8 is also provided with several skin surface temperature acquisition components for collecting the skin surface temperature of the patient's infusion area. The skin surface temperature acquisition components include several temperature sensors 10 (preferably JCJ100TTP-D type patch digital temperature sensors 10) evenly distributed along the circumference of the adhesive patch 3. The temperature sensors 10 are all fixedly connected to the adhesive pouch layer 8.

[0059] If extravasation occurs during intravenous infusion, the heat exchange between the extravasated medication and subcutaneous tissue or the irritant inflammatory response will cause characteristic changes in the skin temperature of the leakage area (e.g., local cooling caused by low-temperature medication, or inflammatory warming induced by irritant medication). The setup of several temperature sensors 10 allows for real-time acquisition of skin temperature data from multiple points in the infusion area. The central controller 7 analyzes the temperature gradient differences at each point to identify temperature anomalies in the leakage area (e.g., the difference between the local temperature and the surrounding normal area exceeds a threshold of 0.4℃). Simultaneously, when the near-infrared SmartTouch sensor 9 collects abnormal subcutaneous tissue structure data due to the patient's fat thickness or skin color depth, the temperature sensor 10 readings in the corresponding area will show a mismatch with the near-infrared signal (e.g., near-infrared readings indicate suspected leakage, but the temperature in that area does not change significantly, or the temperature gradient range is inconsistent with the abnormal range detected by near-infrared). The central controller 7 can cross-verify the consistency of the two data sets, thereby determining whether there is a deviation in the near-infrared acquisition and ensuring the accuracy and reliability of the infusion leakage monitoring results.

[0060] In addition, this embodiment also includes a hydraulic acquisition component for collecting the infusion pressure of the liquid in a disposable infusion set, combined with... Figure 1 and Figure 2As shown, the hydraulic acquisition component includes several pressure sensors 503 embedded in the sidewall of the corresponding pressure tube block 502. Both the pressure sensors 503 and the actuator 501 are electrically connected to the central controller 7. The central controller 7 presets the pressure threshold of the pressure sensors 503 (the pressure threshold is preset according to different disposable infusion set models, which does not affect the normal delivery of the medicine and can amplify the radial pressure change of the disposable infusion set tube wall), and then uses the pressure threshold as a reference to control the actuator 501 to drive the pressure tube block 502 to pre-pressurize the disposable infusion set. During the infusion process, the radial pressure dynamic data of the disposable infusion set tube wall is continuously fed back through several pressure sensors 503, the radial pressure change curve is extracted, and the radial pressure change curve is converted into the corresponding infusion pressure value, realizing non-invasive infusion pressure detection on the disposable infusion set.

[0061] Based on the collected skin surface temperature data, subcutaneous tissue structure distribution changes, and infusion pressure values, the central controller 7 uses a convolutional neural network model to extract features and rank the importance of the skin surface temperature data, subcutaneous tissue structure distribution changes, and infusion pressure values, assigning differentiated leakage reference weights to the three types of monitoring data (subcutaneous tissue structure distribution changes are given the highest weight because they directly reflect changes in tissue density and optical properties caused by fluid extravasation; infusion pressure values ​​are given the second highest weight because they are related to tubing patency and extravasation resistance; and skin surface temperature data, as an indirect thermal effect indicator after extravasation, has a relatively low weight). Subsequently, the real-time monitoring values ​​of each data point are weighted according to their corresponding weights. The system integrates calculations and pre-defined threshold ranges for normal physiological and infusion parameters to quantify the risk of infusion leakage. (The threshold ranges for normal physiological and infusion parameters are determined by collecting data from a large multicenter sample of patients of different ages and weight ranges on their normal infusion status under different types of infusion drugs (such as isotonic, hypertonic, and colloidal solutions) and infusion rates. This data is combined with critical monitoring data at the time of leakage. A convolutional neural network model is used for feature clustering and statistical analysis to determine the baseline distribution range of the three types of monitoring data. The critical thresholds are then optimized using ROC curves, and the rationality of the thresholds is verified and calibrated by a team of clinical medical experts to form the final dynamic adaptive threshold range.)

[0062] Based on the generated infusion leakage risk value, an infusion leakage risk level is defined, which includes a normal state, a leakage warning state, and a leakage emergency state. For example, a risk value below 8% of a preset normal threshold is defined as a normal state, between 8% and 25% as a leakage warning state, and above 25% as a leakage emergency state. Then, the infusion leakage risk level is transmitted in real time as a standardized output signal.

[0063] Regarding the transmission of infusion leakage information, in this embodiment, the central controller 7 is also connected to an early warning platform (the central controller 7 establishes a stable two-way signal connection with the early warning platform through a dedicated local area network within the hospital or a low-latency 5G Internet of Things communication module). The early warning platform includes a nurse station terminal (the nurse station terminal is integrated into the nurse station computer in a conventional hospital) and several individual terminals (the individual terminals can be integrated into the smart medical care wristbands, mobile nursing PDAs, or smartphones worn by medical staff).

[0064] The central nurse station receives real-time data on infusion leakage risk levels from the central controller 7, automatically associates this with the corresponding patient's bed number, and simultaneously transmits the patient's bed number and warning signal to several individual terminals according to preset risk grading trigger rules. It also synchronously stores all patients' infusion leakage risk level data and historical records. These risk grading trigger rules should be comprehensively formulated based on the clinical risk grading of the medication (e.g., non-irritating infusions, irritating drugs, highly corrosive drugs), real-time monitored skin surface temperature gradient differences and the proportion of near-infrared subcutaneous structural abnormalities, and the patient's specific risk factors (e.g., infants, elderly patients, patients with broken skin or sensitive skin). For example:

[0065] When non-irritating drug leakage is detected and the skin surface temperature gradient difference is ≤0.3℃ and the abnormal coverage area is <8%, a low-risk warning is triggered and pushed only to the individual terminal of the responsible nurse of the corresponding patient.

[0066] When irritant drugs leak and the temperature gradient difference is between 0.3-0.8℃, and the abnormal coverage area accounts for 8%-15%, a medium-risk warning is triggered, which is simultaneously pushed to the individual terminals of the responsible nurse and the ward shift leader, accompanied by a mild audio-visual prompt at the nurse station's main terminal.

[0067] When highly corrosive drugs leak, or when the temperature gradient difference is greater than 0.8℃ or the abnormal coverage area is greater than 15%, a high-risk warning is triggered. The warning is immediately pushed to the individual terminals of all on-duty medical staff and the central terminal of the nurse station to issue an emergency audible and visual alarm and link with the ward broadcast system to achieve the fastest possible emergency response.

[0068] Individual terminals: All terminals receive patient bed numbers and warning signals transmitted from the central nursing station in real time. When a patient bed number and warning signal are received, vibration or audio-visual alerts are immediately triggered.

[0069] However, in the actual infusion process, from "the central controller 7 detecting the risk of infusion leakage" to "the risk level of infusion leakage being transmitted to the nurse station", then to "the individual receiving the bed number and the infusion leakage signal", and finally to "the nurse rushing to check or handle the situation", there is a significant data link delay and action time. Given the high harm of infusion leakage, especially the extravasation of highly irritating or corrosive medications which can quickly cause serious complications such as subcutaneous tissue inflammation, necrosis, or even functional impairment, the above-mentioned delays may lead to a delay in intervention.

[0070] Therefore, in this embodiment, the bottom of the attachment 3 is also provided with a seepage-limiting component for dynamic activation based on the risk of infusion leakage, specifically combined with... Figure 4 and Figure 5 As shown, the permeation limiting component includes several compression airbag rings 11 that are welded and fixed to the bottom of the attachment plate 3. The compression airbag rings 11 are fixedly connected to each other and sequentially connected. The inner diameter of the compression airbag rings 11 decreases gradually with respect to the center point of the bottom surface of the attachment plate 3 (forming a multi-layer annular compression structure with a gradually increasing pressure gradient from the outside to the inside). The output end of the pumping component 6 is connected to the compression airbag ring 11 with the largest inner diameter.

[0071] When the central controller 7 detects a risk of infusion leakage and issues a trigger signal, the pump 6 immediately starts and injects gas into the largest inner diameter compression ring 11. The gas quickly fills all the compression rings 11 and expands. Combined with the close fit between the patch 3 and the patient's wrist skin under the action of the patch layer 8, the ring barrier effect of the compression rings 11 closes the gaps around the subcutaneous tissue, preventing the leaked medication from spreading to the surrounding healthy tissue. On the other hand, the high-pressure compression rings 11 in the inner layer confine the leaked medication to the local central area covered by the patch 3, preventing it from penetrating to a larger area of ​​subcutaneous tissue. This effectively controls the spread of leakage before medical personnel arrive on-site for professional treatment, significantly reducing the risk of serious complications such as subcutaneous inflammation and tissue necrosis caused by extravasation of highly irritating or corrosive medications. In addition, the compression rings 11 also promote blood return, facilitating the formation of blood return within the disposable infusion set, making it easier for nurses to check for infusion leakage upon arrival at the bedside.

[0072] To further improve the effectiveness of stopping leakage, based on the non-invasive infusion pressure detection on the disposable infusion set, this embodiment can also send drive commands to two actuators 501 simultaneously through the central controller 7. The actuators 501 drive the pressure block 502 to symmetrically squeeze the flexible tube wall of the infusion tube from the radial direction, so that the inner cavity of the infusion tube of the disposable infusion set can be closed quickly to achieve automatic stopping of leakage. It can quickly cut off the supply of medicine before medical staff arrive (especially when the patient is unaware of the infusion leakage), reduce the continuous outflow of the leaked medicine, and form a dual protection of stopping leakage and limiting leakage with the squeezing air ring 11, further reducing the harm of infusion leakage to the patient's subcutaneous tissue.

[0073] Example 2:

[0074] The difference from Example 1 is that, as shown in the appendix Figure 5 As shown, the bottom of the patch 3 is also provided with a disposable silicone sleeve 12, which covers the bottom of the patch layer 8 and several compression airbags. The disposable silicone sleeve 12 has several collection ports corresponding to the temperature sensor 10 and the SmartTouch sensor 9, respectively. The design of the disposable medical silicone sleeve can effectively isolate the patch layer 8, the compression airbag ring 11 and other components from direct contact with the patient's skin, avoiding the risk of cross-infection caused by repeated use of these non-disposable structures and the skin allergies or irritation caused by material contact. At the same time, the flexible sealing properties of the disposable medical silicone sleeve can enhance the fit between the patch 3 and the wrist skin. When the compression airbag ring 11 is inflated to form a ring of pressure, it buffers the airbag pressure and maintains the sealing of the compression area. It further compresses the airbag ring 11 to block the spread of leaked medicine, which meets the clinical infection control standards and can ensure the safety of use without complicated cleaning and disinfection procedures.

[0075] Example 3:

[0076] The difference from Example 2 is that, as shown in the appendix Figure 5 As shown, the connecting ports between several compression airbags are staggered at different heights. This design allows the gas injected by the pump 6 to start filling the outer compression airbag ring 11 with the largest inner diameter. Due to the height difference of the connecting ports, the gas will flow sequentially to the inner compression airbag ring 11 with decreasing inner diameter, forming a gradual filling process from the outside to the inside (i.e., from the direction away from the infusion insertion point to the direction closer to the infusion insertion point). This simulates the standard operation of medical staff manually pushing from the outside to the center to limit the spread of the drug when leakage is discovered. The outer compression airbag ring 11 first forms a ring barrier to block the outward spread of the drug, and then the inner compression airbag ring 11 gradually increases the pressure in the central area, further confining the leaked drug to the local central area covered by the patch 3, and preventing the infusion drug from penetrating into a larger area of ​​subcutaneous tissue.

[0077] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A device for monitoring, alarming, and stopping intravenous infusion leakage, comprising a wristband, characterized in that, The wristband includes a disposable wristband (1), a digital display screen (2) and an attachment (3). The attachment (3) has an elliptical needle groove (301). The bottom of the digital display screen (2) is fixedly connected to a connecting shell (4) that is detachably connected to the disposable wristband (1). The connecting shell (4) integrates a central controller (7) that is electrically connected to the digital display screen (2). The bottom of the patch (3) is provided with an adhesive layer assembly for attaching to the skin surface of the patient's infusion area. The bottom of the adhesive layer assembly is provided with a near-infrared acquisition assembly for collecting the distribution changes of the subcutaneous tissue structure of the patient's infusion area by emitting and receiving near-infrared light. The bottom surface of the adhesive layer assembly is also provided with several skin surface temperature acquisition assemblies for collecting the skin surface temperature of the patient's infusion area. The connecting shell (4) is connected to an electrically controlled stop clamp (5) fitted on the disposable infusion set. The electrically controlled stop clamp (5) is equipped with a hydraulic acquisition component for collecting the infusion pressure of the liquid in the disposable infusion set. The hydraulic acquisition component, temperature acquisition component and near-infrared acquisition component are all electrically connected to the central controller (7). The central controller (7) receives and analyzes the skin surface temperature data, the information on the distribution changes of subcutaneous tissue structure and the infusion pressure value in real time, and dynamically assesses and predicts the risk of infusion leakage. The bottom of the adhesive patch (3) is also equipped with a seepage limiting component for dynamic driving according to the risk of infusion leakage. The seepage limiting component and the electrically controlled liquid stop clamp (5) are both electrically connected to the central controller (7). The central controller (7) is also connected to an early warning platform, which includes a central terminal at the nurse station and several individual terminals; The nurse station terminal is used to receive the infusion leakage risk level sent by the central controller (7) in real time, automatically associate the corresponding patient's bed number information, and at the same time, the nurse station terminal transmits the patient's bed number and warning signal to several individual terminals according to the preset risk level triggering rules, and synchronously stores the infusion leakage risk level data and historical records of all patients. Each individual terminal is used to receive patient bed numbers and warning signals transmitted from the central nursing station in real time. When a patient bed number and warning signal are received, a vibration or audio-visual reminder is immediately triggered.

2. The monitoring, alarm, and stopping device for infusion leakage according to claim 1, characterized in that, The specific methods by which the central controller (7) dynamically assesses and predicts the risk of infusion leakage are as follows: The central controller (7) performs feature extraction and importance ranking on skin surface temperature data, subcutaneous tissue structure distribution change information and infusion pressure value based on the convolutional neural network model, assigns differentiated leakage reference weights to the three types of monitoring data, and then performs weighted fusion calculation on the real-time monitoring values ​​of each data and the corresponding weights, and obtains the quantitative infusion leakage risk value by combining the preset normal physiological and infusion parameter threshold ranges. The infusion leakage risk level is then defined based on the infusion leakage risk value. The infusion leakage risk level includes normal state, leakage warning state and leakage emergency state. The infusion leakage risk level is transmitted to the nurse station terminal in real time as a standardized output signal.

3. The monitoring, alarm, and stopping device for infusion leakage according to claim 2, characterized in that, A pumping unit (6) is fixedly connected inside the connecting housing (4). The adhesive layer assembly includes an adhesive bladder layer (8) fixedly connected to the bottom of the adhesive piece (3). The adhesive bladder layer (8) corresponds to the shape of the adhesive piece (3). The adhesive bladder layer (8) is connected to the output end of the pumping unit (6).

4. The monitoring, alarm, and stopping device for infusion leakage according to claim 3, characterized in that, The near-infrared acquisition component includes symmetrical SmartTouch sensors (9), all of which are fixedly connected to the bottom surface of the attached capsule layer (8).

5. The monitoring, alarm, and stopping device for infusion leakage according to claim 4, characterized in that, The skin surface temperature acquisition component includes several temperature sensors (10) evenly distributed around the circumference of the adhesive patch (3), and the temperature sensors (10) are all fixedly connected to the adhesive capsule layer (8).

6. The monitoring, alarm, and stopping device for infusion leakage according to claim 5, characterized in that, The electrically controlled liquid stop clamp (5) includes actuators (501) arranged symmetrically and oppositely, and the output ends of the two actuators (501) are fixedly connected to pressure pipe blocks (502).

7. The monitoring, alarm, and stopping device for infusion leakage according to claim 6, characterized in that, The hydraulic acquisition component includes several pressure sensors (503) embedded in one side wall of the corresponding pressure tube block (502). The pressure sensors (503) and the actuator (501) are both electrically connected to the central controller (7). The central controller (7) uses the preset pressure threshold of the pressure sensor (503) as a reference to control the actuator (501) to drive the pressure block (502) to pre-pressurize the disposable infusion set. During the infusion process, the radial pressure dynamic data of the disposable infusion set tube wall is continuously fed back through several pressure sensors (503), the radial pressure change curve is extracted, and the radial pressure change curve is converted into the corresponding infusion pressure value.

8. The monitoring, alarm, and stopping device for infusion leakage according to claim 7, characterized in that, The permeation limiting component includes several compression airbag rings (11) fixedly connected to the bottom of the attachment plate (3). The inner diameter of the compression airbag rings (11) decreases gradually from the center point of the bottom surface of the attachment plate (3). The compression airbag rings (11) are fixedly connected to each other and connected in sequence. The output end of the pump (6) is connected to the compression airbag ring (11) with the largest inner diameter.

9. The monitoring, alarm, and stopping device for infusion leakage according to claim 8, characterized in that, The connecting ports between the various compression airbags are staggered at different heights.

10. The monitoring, alarm, and stopping device for infusion leakage according to claim 9, characterized in that, The bottom of the adhesive patch (3) is also provided with a disposable silicone sleeve (12). The disposable silicone sleeve (12) covers the bottom of the adhesive bladder layer (8) and several compression bladders. The disposable silicone sleeve (12) has several collection ports corresponding to the temperature sensor (10) and the SmartTouch sensor (9).

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