Dual-hanging position state exclusive infusion management device

Abstract

The application discloses a double-hanging-position state mutual exclusion infusion management device, which comprises an infusion hanger, a code scanning and recognizing unit, a double-path sensing and collecting module, a pipeline blocker and an electric control module; the infusion hanger is provided with a first hanging position and a second hanging position; the electric control module realizes a finite state machine, and according to the code scanning input, the two hanging positions are allocated with mutually exclusive execution and pre-storage states; the state machine controls the on-off of the pipeline blocker according to the state identifier, and only one hanging position is allowed to be in execution at the same time; the state machine is prohibited from generating a medical order execution time stamp during the pre-storage period, and only during the execution period. Through the mutual exclusion state identifier and the pre-storage prohibition timing mechanism, the quality control defects of the time overlap of the medical orders of multiple bags of liquid medicine in the double-fork infusion scene are solved, and the compliance requirements of the uniqueness of the medical order execution time are met.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to intelligent infusion management equipment, and more particularly to an infusion auxiliary device that achieves sequential management of medical orders for a dual-branch infusion set through physical partitioning and state machine collaboration. Background Technology

[0002] Intravenous infusion is the most common route of drug administration in clinical practice. Double-forked / Y-type double-bag infusion sets are widely used clinically, allowing multiple bags of medication to be infused sequentially through a single infusion tubing. Existing mobile nursing systems typically use PDAs to scan barcodes to execute medical orders, but PDAs only support single-bag, single-time-period order entry and cannot pre-store, differentiate, or manage the timing of multiple bags of medication suspended on the same rack.

[0003] Existing intelligent infusion devices are mostly limited to single functions such as liquid level alarm and drip rate monitoring. A search reveals that existing related patents can be categorized as follows: (I) Dual-channel / multi-bag automatic switching type, such as CN111632227A and CN120789390A, can achieve sequential switching, but lacks a barcode scanning function for matching medical orders, and cannot distinguish between "currently infused" and "to be infused" medications. Pre-stored medications can generate execution times, resulting in overlapping medical order times; (II) Multi-sensor fusion monitoring type, such as CN117838983A and CN120695300A, uses multi-sensor fusion for flow rate warning or status monitoring, but lacks joint judgment of dual-signal trend correlation. (iii) Pipeline blocking / mechanical switching type, such as CN221557125U, which implements dual-pipe blocking purely in hardware, without scanning or timing management; (iv) Data traceability / encryption type, such as CN109381775A, which is encrypted storage at the background data level and is not bound to the device's local state switching event hardware; (v) Classic multi-bag switching type, such as CN110269971A and CN107693885A, which do not set up mutually exclusive state machines to distinguish between execution and pre-stored, and cannot avoid the overlap of medical order execution time.

[0004] Currently, the industry's research and development of intelligent infusion equipment focuses on "automatic tubing switching and reducing nurses' medication changes," generally neglecting a crucial issue: the mandatory quality control requirements of HIS electronic medical records and medical insurance records regarding the uniqueness of medical order execution times. In hospital accreditation and medical insurance record verification, "only one set of valid medical orders for the same patient and the same infusion route at the same time period" is a basic compliance requirement. However, existing dual-channel automatic switching devices only focus on "whether the fluid has been completely infused," neglecting "whether medical order times overlap"—pre-stored medications generate execution times when scanned and stored in the device, causing multiple sets of medications to have overlapping effective infusion time periods at the system level, leading to medical record defects. Summary of the Invention

[0005] In view of this, the present invention provides an infusion management device with mutually exclusive dual-position states to solve the problem that existing devices cannot actively manage the execution sequence of multiple bags of medication when multiple bags of medication are pre-attached in a dual-fork infusion, resulting in overlapping medication times and frequent quality control defects.

[0006] The infusion management device of the present invention with mutually exclusive dual hanging positions includes an infusion hanger, a first barcode scanning and identification unit, a second scanning and identification unit, a dual-channel sensor acquisition module, a first pipeline blocker, a second pipeline blocker, and an electronic control module; the infusion hanger includes a frame and a first hook and a second hook disposed on the frame, with the first hook corresponding to the first hanging position and the second hook corresponding to the second hanging position.

[0007] The first barcode scanning and identification unit is located at the first hanging position and is used to read the barcode information of the medicine liquid on the first hanging position and send it to the electronic control module; the second barcode scanning and identification unit is located at the second hanging position and is used to read the barcode information of the medicine liquid on the second hanging position and send it to the electronic control module.

[0008] The first dual-channel sensor acquisition module is set on the first infusion branch corresponding to the first suspension position, and is used to acquire the drip rate signal and liquid level signal of the first infusion branch and send them to the electronic control module; the second dual-channel sensor acquisition module is set on the second infusion branch corresponding to the second suspension position, and is used to acquire the drip rate signal and liquid level signal of the second infusion branch and send them to the electronic control module.

[0009] The first pipeline blocker is used to be installed on the first infusion branch and is controlled by the electronic control module to open and close the first infusion branch; the second pipeline blocker is used to be installed on the second infusion branch and is controlled by the electronic control module to open and close the second infusion branch.

[0010] The electronic control module includes a microcontroller and a memory. The memory stores a computer program, which is executed by the microcontroller to implement a finite state machine. The finite state machine assigns mutually exclusive state flags to the first dangling bit and the second dangling bit based on the input of the first barcode scanning unit and / or the second barcode scanning unit. The state flags include at least "in execution" and "pre-stored".

[0011] The finite state machine generates control commands based on the state identifier and sends them to the first and second pipeline blockers respectively: when the first suspended position is marked as in operation, the first pipeline blocker is released from blocking; when the first suspended position is marked as pre-stored, the first pipeline blocker remains blocked; when the second suspended position is marked as in operation, the second pipeline blocker is released from blocking; when the second suspended position is marked as pre-stored, the second pipeline blocker remains blocked; the finite state machine allows only one suspended position to be in the in operation state at any given time.

[0012] The finite state machine is prohibited from generating the medical order execution timestamp corresponding to the suspended bit while the suspended bit is marked as pre-stored; the medical order execution timestamp corresponding to the suspended bit is only generated and recorded while the suspended bit is marked as in execution.

[0013] Furthermore, the finite state machine only triggers state switching after the dual-channel sensor acquisition module has jointly verified and determined that the liquid has been emptied;

[0014] The joint verification is as follows: the drip rate signal and liquid level signal collected by the dual-channel sensor acquisition module corresponding to the currently executing suspension position are obtained, and a drain confirmation signal is sent to the finite state machine only when the drip rate signal is lower than the first threshold for N consecutive sampling periods, the liquid level signal is lower than the second threshold, and the changing trends of the drip rate signal and the liquid level signal are positively correlated within a preset time window.

[0015] Furthermore, the electronic control module is equipped with an independent hardware security clock chip. The timestamp generated during state switching is stored in the unwritable storage area of ​​the security clock chip in an encrypted format. During each state switching, the finite state machine packages the states before and after the switch, the switching timestamp, and the sensor data sequence that triggered the switch into an indivisible data packet for storage.

[0016] The electronic control module is also equipped with a wireless communication module, which is used to upload the data packet along with the device's unique hardware code to the hospital information system.

[0017] Furthermore, the state identifiers assigned by the finite state machine to the first and second suspended bits also include "idle" and "completed"; the state transition rules of the finite state machine are as follows:

[0018] The condition for the first or second hanging position to be converted from idle to pre-stored is: the hanging position is scanned and matched by the first or second barcode scanning unit located thereon, and the barcode integrity detection is passed;

[0019] The condition for the first suspension position to be converted from pre-stored to in execution is: the second suspension position is in execution, and the dual-channel sensor acquisition module corresponding to the second suspension position sends a drain confirmation signal;

[0020] The condition for the second suspension position to be converted from pre-stored to in execution is: the first suspension position is in execution, and the dual-channel sensor acquisition module corresponding to the first suspension position sends a drain confirmation signal.

[0021] The condition for the first or second pending position to change from being executed to being completed is: after the state switch is completed, the pending position that was originally being executed will automatically change to being completed;

[0022] At any given time, only one of the first and second suspension positions is allowed to be in the state of execution.

[0023] Furthermore, the finite state machine is also configured with anomaly warning rules;

[0024] When the drip rate signal is continuously lower than the first threshold, the liquid level signal is not lower than the second threshold, and the changing trends of the drip rate and the liquid level are not related, the finite state machine determines that the path blockage is abnormal, triggers the path blockage warning, maintains the current state unchanged, and does not perform state switching.

[0025] When the drip rate signal is higher than the third threshold, the liquid level signal is not lower than the second threshold, and the changing trends of the drip rate and the liquid level are not related, the finite state machine determines that the fluid leakage is abnormal, triggers the leakage warning, and controls the pipeline blocker corresponding to the currently executing suspension position to block and prevent the drug solution from continuing to be infused.

[0026] After the warning is triggered, the finite state machine issues an alarm prompt through the human-machine interaction module and records the abnormality type, trigger time and corresponding sensor data sequence in the memory.

[0027] Furthermore, the electronic control module stores a drug incompatibility database or has an interface to call the incompatibility database of the hospital information system; when the finite state machine executes the first suspended position or the second suspended position and switches from idle to pre-stored, it automatically checks whether there is a drug incompatibility between the currently executing suspended position drug and the suspended position drug to be transferred to the pre-stored; if there is a conflict, the conversion is rejected.

[0028] The finite state machine also has a built-in priority scheduling rule. When it is identified that the liquid medicine to be transferred to the pre-stored state has the priority of ST (immediate) or rescue, the currently executing suspended position is paused and the high priority suspended position is switched to execution.

[0029] Furthermore, both the first and second barcode scanning units employ barcode scanning modules to read and decode the drug barcode information on the infusion bag before sending it to the electronic control module.

[0030] Furthermore, both the first and second pipeline stoppers are electric clamp valves.

[0031] Furthermore, both the first dual-channel sensor acquisition module and the second dual-channel sensor acquisition module include an infrared drop count detector and a capacitive liquid level sensor; the infrared drop count detector is used to acquire the drop rate signal, and the capacitive liquid level sensor is used to acquire the liquid level signal.

[0032] Furthermore, the infusion management device with mutually exclusive dual mounting positions also includes a body, on which the first dual-channel sensor acquisition module, the second dual-channel sensor acquisition module, the first pipeline blocker, the second pipeline blocker, and the electrical control module are mounted, and the body is also provided with mounting holes.

[0033] The beneficial effects of this invention are:

[0034] 1. This invention uses a finite state machine to assign mutually exclusive "in execution" and "pre-stored" state identifiers to the first and second suspended positions, and prohibits the generation of medical order execution timestamps during the "pre-stored" period, thereby fundamentally solving the long-standing problem of overlapping medical order times in the dual-branch infusion scenario.

[0035] Compared to existing technologies, current dual-channel automatic switching devices generate execution timestamps when scanning pre-stored medications, causing overlapping effective infusion time periods for multiple medications at the system level, leading to medical record defects. With this invention, because the generation of medical order execution timestamps is prohibited in the pre-stored state, the defect of overlapping medical order times is fundamentally eliminated, fully meeting the compliance requirements of hospital accreditation and medical insurance record verification that "only one set of valid medical orders for the same patient and the same route during the same time period."

[0036] 2. This invention constructs a pipeline blocking control mechanism driven by a dual condition of "code verification + status bit". The pipeline blocker does not directly respond to sensor signals, but responds to the status flag of the finite state machine, forming a logical isolation layer between software decision-making and mechanical execution. Even if the sensor falsely alarms (such as a sudden drop in drip rate caused by air bubbles), as long as the state machine does not receive the purging confirmation signal from the joint verification, the status bit remains unchanged, and the state of the blocker also remains unchanged, effectively preventing erroneous switching.

[0037] 3. This invention uses the positive correlation between the changing trends of the drip rate signal and the liquid level signal within a preset time window as the basis for confirming the emptying of the drug solution, which is different from the simple "simultaneous achievement of dual signals" logic in the prior art.

[0038] In clinical practice, various pathway obstructions, such as tubing kinking and compression, needle blockage, large air bubbles in the tubing, and detachment of the upstream tubing of the drip chamber, can all lead to an abnormal decrease in drip rate. However, in these cases, the medication in the infusion container is not being continuously consumed, and the fluid level detection signal will not decrease synchronously. The trend-based positive correlation determination of this invention can effectively filter out the above-mentioned single signal anomalies—in a real emptying process, the drip rate and fluid level show a synchronous positive correlation; while in abnormal situations such as tubing kinking, only the drip rate decreases while the fluid level remains unchanged, and the trends of the two changes are unrelated, thus effectively distinguishing them.

[0039] Similarly, fluid leakage faults such as needle dislodgement from the blood vessel, detachment of the downstream tubing of the drip chamber, or tubing rupture and leakage manifest as an abnormally increased drip rate while the fluid level in the infusion tubing remains unchanged. The trends of these two changes are also uncorrelated and are effectively filtered out by the positive correlation condition, preventing false triggering of emptying confirmation. Therefore, the positive correlation judgment logic adopted in this invention can simultaneously filter out two types of anomalies: pathway obstruction and fluid leakage, achieving immunity to various infusion faults without adding additional sensors or verification logic.

[0040] Building upon this foundation, the present invention can also be extended to implement an infusion anomaly alarm function. By analyzing the combined characteristics of drip rate and liquid level signals: a decrease in drip rate accompanied by a constant liquid level indicates a blockage in the flow path; an increase in drip rate accompanied by a constant liquid level indicates fluid leakage; and a simultaneous decrease in drip rate and liquid level indicates normal emptying. These three conditions can be distinguished using the same set of sensor signals, eliminating the need for additional hardware and enabling multi-type fault monitoring and alarms throughout the entire infusion process.

[0041] 4. This invention employs an independent hardware secure clock chip. The timestamp generated during state switching is encrypted and stored in an unwritable storage area. The states before and after the switch, the switching timestamp, and the sensor data sequence triggering the switch are packaged into an indivisible data packet for storage. Simultaneously, the data packet, along with the device's unique hardware code, is uploaded to the hospital information system via a wireless communication module.

[0042] This design forms a complete traceability chain from state switching events to timestamps, sensor data, and operation logs. Quality control data is a natural output of equipment operating state transitions, not manually supplemented afterward, meeting the requirements of graded hospital accreditation for the completeness, accuracy, and immutability of medical order execution records.

[0043] 5. This invention introduces multiple security checks and fault-tolerance mechanisms during state transitions, improving the reliability and clinical applicability of the device:

[0044] Drug incompatibility verification: When the finite state machine executes the "idle → pre-store" state transition, it automatically retrieves the drug incompatibility database or the hospital information system's incompatibility database to verify whether there is any incompatibility between the currently executing suspended drug and the suspended drug to be transferred to the pre-store. If a conflict exists, the state machine refuses to execute the state transition and continuously issues a warning, thus preventing the risk of drug incompatibility at the control logic level.

[0045] Priority Scheduling: The finite state machine has built-in priority scheduling rules. When it is identified that a drug solution to be transferred to a pre-stored state has an immediate or emergency priority, the currently executing suspended position is paused and the higher priority suspended position is switched to execution. This mechanism allows the device to break the conventional "execute first, then switch" sequence in emergency situations, meeting the special requirements of medication timing in clinical emergency scenarios.

[0046] Automatic / Manual Dual-Mode Switching: The human-machine interface module is configured with automatic and manual confirmation modes, allowing for flexible selection of the state switching execution method based on clinical scenarios. In automatic mode, the state machine automatically executes the state switch upon receiving a drain confirmation signal, reducing nurses' operational steps. In manual confirmation mode, the state machine only triggers a switching request prompt, requiring nurses to confirm via PDA or device buttons before the switch can be executed, providing an additional manual verification step for the infusion of high-risk drugs or special patients.

[0047] Timeout fault tolerance mechanism: After receiving the emptying confirmation signal, the finite state machine performs a state switch. If no emptying confirmation signal is received within a preset time, a prompt signal is triggered. This mechanism avoids the state machine from being stuck in a waiting state for a long time due to sensor failure, pipeline blockage, or operation delay, ensuring the continuity and operability of the infusion process and improving the robustness of the device. Attached Figure Description

[0048] Figure 1 This is a schematic diagram of an infusion management device with mutually exclusive dual mounting positions.

[0049] Figure 2 This is a schematic diagram of the combination of infusion bag, infusion set and infusion management device. Detailed Implementation

[0050] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0051] As shown in the figure, the infusion management device with mutually exclusive dual hanging positions in this embodiment includes an infusion hanger 1, a first barcode scanning and identification unit 2, a second scanning and identification unit 3, a first dual-channel sensor acquisition module 4, a second dual-channel sensor acquisition module 5, a first tubing blocker 6, a second tubing blocker 7, and an electronic control module 8. The infusion hanger includes a frame 101 and a first hook 102 and a second hook 103 disposed on the frame 101. The first hook corresponds to the first hanging position, and the second hook corresponds to the second hanging position. The first hook 102 and the second hook 103 are used to hang infusion bags or infusion bottles. In this embodiment, the infusion management device with mutually exclusive dual hanging positions also includes a body 9. The first dual-channel sensor acquisition module 4, the second dual-channel sensor acquisition module 5, the first tubing blocker 6, the second tubing blocker 7, and the electronic control module 8 are disposed on the body 9. The body is also provided with a hanging hole 10, which facilitates connection with the hooks on the infusion hanger 1.

[0052] The first barcode scanning unit 2 is located at the first suspension position and is used to read the barcode information of the medicine liquid on the first suspension position and send it to the electronic control module. The second barcode scanning unit 3 is located at the second suspension position and is used to read the barcode information of the medicine liquid on the second suspension position and send it to the electronic control module. In this embodiment, the first and second barcode scanning units are respectively fixed to the suspension base 11 with screws, and the suspension base is connected to the frame 101. Specifically, the suspension base 11 can be connected to the frame 101 by welding, hook attachment, elastic clamping, etc. Both the first and second barcode scanning units can use CMOS image barcode scanning modules, such as the Honeywell N368X series, or the Newland EM20 series or other modules with equivalent functions. The module has a built-in CMOS image sensor and a supplementary LED, and is connected to the microcontroller of the electronic control module through a UART serial interface. When the IV bag is hung in the hanging position, the supplemental LED automatically illuminates to provide sufficient lighting. The CMOS image sensor captures an image of the barcode area on the IV bag, and the decoding chip inside the module decodes the captured image to extract the medication barcode information. If the barcode is torn, damaged, or missing, preventing normal decoding, the module reports decoding failure or barcode abnormality information to the electronic control module.

[0053] The first dual-channel sensor acquisition module is set on the first infusion branch corresponding to the first suspension position, and is used to collect the drip rate signal and liquid level signal of the first infusion branch and send them to the electronic control module; the second dual-channel sensor acquisition module is set on the second infusion branch corresponding to the second suspension position, and is used to collect the drip rate signal and liquid level signal of the second infusion branch and send them to the electronic control module. In this embodiment, the first dual-channel sensor acquisition module 4 includes an infrared drop count detector 41 and a capacitive liquid level sensor 42. The infrared drop count detector adopts a through-beam infrared sensor, including an infrared emitting tube and an infrared receiving tube, which are respectively installed on both sides of the slot on the body 10 for securing the infusion drip chamber 12; its working principle is as follows: the infrared emitting tube continuously emits infrared light, and the infrared receiving tube receives the light transmitted through the drip chamber; when the medicine drips through the drip chamber, the droplet blocks the infrared light path, causing the signal intensity output by the receiving tube to drop instantaneously, forming a pulse signal; the microcontroller calculates the drip rate (drops / minute) by counting the number of pulses per unit time. The capacitive level sensor employs a C-shaped snap-fit ​​structure with a side opening. A slight elastic deformation allows the 3mm–5mm outer diameter infusion tube to be inserted laterally into the positioning groove, ensuring the inner sensing plate non-contactly surrounds the outer wall of the tube. The working principle of the capacitive level sensor is based on the difference in dielectric constant between the medication and air. When the infusion tube is full of medication, the sensor detects a high equivalent capacitance value; when the medication is emptied and air enters the tube, the equivalent capacitance value decreases significantly. The sensor integrates a signal processing circuit that converts the capacitance change into a switching signal output: a high level is output when medication is detected in the tube, and a low level is output when the tube is emptied. This signal is sent to the microcontroller of the electronic control module via the I / O interface for level determination during joint verification. The structure of the second dual-channel sensing acquisition module 5 is the same as that of the first dual-channel sensing acquisition module 4.

[0054] The first tubing stopper 5 is installed on the first infusion branch and controlled by the electronic control module to open and close the first infusion branch; the second tubing stopper 6 is installed on the second infusion branch and controlled by the electronic control module to open and close the second infusion branch. In this embodiment, both the first and second tubing stoppers are electric clamp valves, which are commonly used tubing on / off control components in medical infusion equipment.

[0055] The electronic control module includes a microcontroller (e.g., STM32 series) and a memory (e.g., Flash memory chip). The memory stores a computer program, which, when executed by the microcontroller, implements a finite state machine. When the first or second barcode scanning unit successfully reads the medication barcode information on the infusion bag and sends the decoded data to the electronic control module, the finite state machine assigns mutually exclusive state identifiers to the first and second hanging positions based on the input from the first and / or second barcode scanning units. These state identifiers include at least "in execution" and "pre-stored." For example, when the nurse hangs the first bag of medication in the first hanging position and completes the scanning, if neither the first nor the second hanging position is currently marked with any state, the finite state machine marks the first hanging position as "in execution." Subsequently, when the nurse hangs the second bag of medication in the second hanging position and completes the scanning, since the first hanging position is already in "in execution," the finite state machine marks the second hanging position as "pre-stored." These two status flags are mutually exclusive; that is, at any given time, only one suspended bit is allowed to be in the "in execution" state, while the other suspended bit can only be in the "pre-stored" state.

[0056] The finite state machine generates corresponding control commands based on the state identifiers and sends them to the first and second pipeline blockers respectively through the microcontroller's I / O ports. The control logic is as follows: when the first suspension position is marked as "in execution," the first pipeline blocker is released, and drug infusion begins; when the first suspension position is marked as "pre-stored," the first pipeline blocker remains blocked, preventing drug flow. When the second suspension position is marked as "in execution," the second pipeline blocker is released, and drug infusion begins; when the second suspension position is marked as "pre-stored," the second pipeline blocker remains blocked, preventing drug flow. The finite state machine allows only one suspension position to be in the "in execution" state at any given time, thus ensuring that only one set of drugs is infused at any given time.

[0057] The finite state machine is prohibited from generating a timestamp for the execution of a medical order when the hanging position is marked as pre-stored; even if the hanging position has been scanned and the medication has been loaded and ready, the execution start time of the medication will not be reported to the hospital information system. The timestamp for the execution of a medical order corresponding to the hanging position is only generated and recorded when the hanging position is marked as in execution.

[0058] As an improvement to the above embodiment, the finite state machine only triggers a state switch after the dual-channel sensor acquisition module determines that the medication has been emptied through joint verification. For example, when the first suspension position is in the "in execution" state, the first dual-channel sensor acquisition module collects the drip rate signal and liquid level signal on the infusion line corresponding to the suspension position in real time, and sends the collected data to the microcontroller of the electronic control module. The microcontroller performs joint verification on the received drip rate signal and liquid level signal to determine whether the medication has been emptied. The joint verification judgment conditions include the following three items, which must be satisfied simultaneously:

[0059] 1) Drop rate condition: The drop rate signal is lower than a first threshold for N consecutive sampling periods. In this embodiment, N is 10, and the first threshold is 5 drops / minute. That is, the microcontroller continuously monitors the drop rate signal, and if the drop rate value is lower than 5 drops / minute for 10 consecutive sampling periods (each sampling period is 1 second), the drop rate condition is determined to be met.

[0060] 2) Liquid Level Condition: The liquid level signal value output by the capacitive liquid level sensor is lower than a preset second threshold. The local pipe section clamped by the capacitive liquid level sensor is pre-calibrated to full scale. The calibration method is as follows: when the local pipe section is full of liquid, it is calibrated to the upper limit of full scale (100%), and when it is emptied, it is calibrated to the lower limit (0%). The second threshold is set to 20% of the upper limit of full scale. When the liquid level signal output by the sensor in real time is lower than this threshold, the liquid level condition is determined to be met.

[0061] 3) Trend Correlation Condition: The drip rate signal and the liquid level signal show a positive correlation within a preset time window. In this embodiment, the microcontroller collects the drip rate and liquid level values ​​at a sampling frequency of once per second within a 10-second time window, obtaining a drip rate sequence and a liquid level sequence containing 10 data points respectively. Then, the ratio of the covariance of these two sequences to their respective standard deviations is calculated to obtain the Pearson correlation coefficient r, which ranges from [-1, 1]. When r is greater than a preset threshold (0.7 in this embodiment), the drip rate and liquid level are determined to be positively correlated. The physical significance of this condition is as follows: In a real process of emptying the medication, as the medication decreases, the drip rate gradually decreases, and the fluid level also gradually decreases, showing a positive correlation between the two. However, in cases of abnormal obstruction such as tubing kinks, needle blockages, or air bubbles, the drip rate decreases, but the infusion tubing remains full of medication, and the fluid level signal does not decrease synchronously; the trends of the two changes are uncorrelated or negatively correlated. Similarly, in cases of fluid leakage such as needle dislodgement from the blood vessel, tubing detachment downstream of the drip chamber, or tubing cracking and leakage, the drip rate abnormally increases while the fluid level in the infusion tubing remains unchanged; the trends of the two changes are also uncorrelated or negatively correlated. Both types of anomalies can be effectively filtered by the positive correlation condition, avoiding false triggering of emptying confirmation.

[0062] When all three conditions are met, the microcontroller determines that the liquid has been drained and sends a drain confirmation signal to the finite state machine. Upon receiving the drain confirmation signal, the finite state machine performs a state transition.

[0063] If the second suspension position is in the "in execution" state, the logic of the joint verification is the same, and the second dual-channel sensor acquisition module collects data and performs the above verification.

[0064] As an improvement to the above embodiments, the three conditions of the joint verification can also be extended to infusion anomaly early warning and intervention. The microcontroller identifies different types of infusion anomalies and triggers corresponding actions based on the combined characteristics of the drip rate signal and the liquid level signal.

[0065] When the drip rate signal is consistently below the first threshold, the liquid level signal is not below the second threshold, and the trends of drip rate and liquid level are unrelated, it is determined to be an abnormal blockage in the flow path (including pipe folding, needle blockage, or detachment of the upstream pipe of the drip chamber). The finite state machine triggers a flow path blockage warning, maintains the current state, does not perform a state switch, and issues an alarm prompt through the human-machine interaction module.

[0066] When the drip rate signal is higher than the third threshold, the liquid level signal is not lower than the second threshold, and the trends of drip rate and liquid level are not correlated, it is determined to be an abnormal fluid leakage (including needle dislodgement from blood vessel, detachment of downstream tubing of drip chamber, leakage due to tubing crack, etc.). The finite state machine triggers a leakage warning and controls the tubing blocker corresponding to the currently executing suspension position to block the flow of medicine and prevent the infusion of medicine. At the same time, an alarm prompt is issued through the human-machine interaction module.

[0067] After the warning is triggered, the finite state machine records the exception type, trigger time and corresponding sensor data sequence in the memory for subsequent traceability and analysis.

[0068] The three judgment logics mentioned above (normal purging, pathway blockage, and fluid leakage) share the same set of sensor signals, and can achieve pathway integrity monitoring and automatic protection throughout the entire infusion process without the need for additional hardware.

[0069] As an improvement to the above embodiments, the electronic control module is equipped with an independent hardware secure clock chip; in this embodiment, the DS3231 high-precision real-time clock chip is used. When the finite state machine performs a state transition (for example, the first dangling bit changes from "in progress" to "completed," and the second dangling bit changes from "pre-stored" to "in progress"), the microcontroller immediately reads the current time from the independent hardware secure clock chip and generates a timestamp for this state transition. This timestamp is stored in an encrypted format (using the AES-128 encryption algorithm in this embodiment) in the unwritable storage area of ​​the secure clock chip, ensuring that once the timestamp is written, it cannot be modified or deleted by subsequent operations. Simultaneously, during each state transition, the finite state machine packages the following information into an indivisible data packet:

[0070] The state before the switch (e.g., first suspending bit = executing, second suspending bit = pre-stored);

[0071] The status after switching (e.g., first hanging position = completed, second hanging position = in progress);

[0072] The timestamp of this state transition (the value read from the secure clock chip and encrypted);

[0073] The sensor data sequence that triggered this state switch includes the drip rate signal data and liquid level signal data collected in the last 30 seconds before the trigger.

[0074] The data packet is encapsulated in a structured binary format inside the microcontroller and an additional cyclic redundancy check code is added to form an indivisible data packet stored in the memory of the electronic control module.

[0075] The electronic control module is also equipped with a wireless communication module. In this embodiment, a Wi-Fi module (such as the ESP8266 series) is used, but a 4G cellular communication module can also be used. After each state transition, the microcontroller uploads the aforementioned data packet along with the device's unique hardware code (in this embodiment, the 48-bit MAC address burned at the factory) to the hospital information system via the wireless communication module. The upload protocol uses HTTPS encrypted transmission to ensure the security and integrity of the data during transmission.

[0076] After receiving the data packet, the hospital information system can parse it and store it in the patient's electronic medical record's medical order execution record for subsequent medical record quality control review and medical insurance verification.

[0077] As an improvement to the above embodiment, the state flags assigned by the finite state machine to the first and second suspended bits further include "idle" and "completed"; the state transition rules of the finite state machine are as follows:

[0078] 1) Idle space converted to pre-stored space

[0079] The condition for the first or second hanging position to transition from idle to pre-stored is as follows: the hanging position is scanned and matched by the first or second barcode scanning unit located therein, and the barcode integrity check passes. If the barcode integrity check fails (e.g., the barcode is torn or damaged, preventing normal decoding), the finite state machine refuses to perform the state transition, the hanging position remains idle, and a prompt is issued through the human-machine interaction module.

[0080] 2) Pre-stored data converted to execution

[0081] The condition for the first suspension position to be converted from pre-stored to in operation is: the second suspension position is in operation, and the dual-channel sensor acquisition module corresponding to the second suspension position sends a discharge confirmation signal.

[0082] The condition for the second suspension position to be converted from pre-stored to in operation is: the first suspension position is in operation, and the dual-channel sensor acquisition module corresponding to the first suspension position sends a discharge confirmation signal.

[0083] 3) Converting from execution to completion

[0084] The condition for the first or second pending position to change from being executed to being completed is: after the state switch is completed, the pending position that was originally being executed will automatically change to being completed;

[0085] 4) State mutual exclusion rule

[0086] At any given time, only one of the first and second suspension positions is allowed to be in the state of execution.

[0087] As an improvement to the above embodiment, the memory of the shown electronic control module stores a drug incompatibility database. This database can adopt the SQLite lightweight embedded database format, cover commonly used intravenous drug incompatibility rules in clinical practice, and support receiving incremental update packets from the hospital information system via a wireless communication module to maintain the timeliness of the data.

[0088] When the finite state machine executes the first or second suspended bit transition from idle to pre-stored, a mismatch check is automatically performed. The specific process is as follows:

[0089] The finite state machine obtains the drug information of the liquid medicine currently being executed by the hanging position (the drug medicine barcode information obtained when scanning the barcode through the hanging position); at the same time, it obtains the drug information of the liquid medicine hanging position to be transferred to the pre-stored state; the finite state machine retrieves the locally stored drug incompatibility database to query whether there is any incompatibility between the two drugs mentioned above.

[0090] If the query results indicate a drug incompatibility (e.g., ceftriaxone sodium is incompatible with calcium-containing solutions), the finite state machine refuses to perform an idle-to-pre-stored state transition, and the suspended bit remains idle. Simultaneously, the finite state machine issues a warning through the human-machine interface module, displaying the message "Incompatible, please change the medication" on the LCD screen, along with the names of the conflicting drugs. Upon receiving the warning, the nurse can either replace the medication with one that does not have incompatibility and rescan the barcode, or manually confirm via PDA and force the transition (requiring the nurse's signature for confirmation).

[0091] In other embodiments, the electronic control module may not store a local database, but instead call the matching database interface of the hospital information system through the wireless communication module to perform real-time queries. After the query results are returned, the finite state machine determines whether to allow state transitions.

[0092] The finite state machine also has a built-in priority scheduling rule. When it is identified that the liquid medicine to be transferred to the pre-stored state has an immediate or emergency priority, the currently executing suspended position is paused and the high-priority suspended position is switched to execution. The specific process is as follows:

[0093] The finite state machine pauses the currently executing suspended position, switches the suspended position from the executing state to the pre-stored state, and controls the corresponding pipeline blocker to maintain the blockage.

[0094] Switching the high-priority suspension position from pre-stored to in operation controls the corresponding pipeline blocker to release the blockage, and the high-priority drug solution begins infusion.

[0095] After the high-priority drug infusion is completed and the fluid is drained, the finite state machine switches the previously suspended suspend position back to execution to continue the infusion.

[0096] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. An infusion management device with mutually exclusive dual mounting positions, characterized in that: The device includes an infusion stand, a first barcode scanning and identification unit, a second scanning and identification unit, a first dual-channel sensor acquisition module, a second dual-channel sensor acquisition module, a first tubing blocker, a second tubing blocker, and an electronic control module. The infusion stand includes a frame and a first hook and a second hook mounted on the frame. The first hook is located below a first suspension position, and the second hook is located below a second suspension position. The first barcode scanning and identification unit is located at the first hanging position and is used to read the barcode information of the medicine liquid on the first hanging position and send it to the electronic control module; the second barcode scanning and identification unit is located at the second hanging position and is used to read the barcode information of the medicine liquid on the second hanging position and send it to the electronic control module. The first dual-channel sensor acquisition module is set on the first infusion branch corresponding to the first suspension position, and is used to acquire the drip rate signal and liquid level signal of the first infusion branch and send them to the electronic control module; the second dual-channel sensor acquisition module is set on the second infusion branch corresponding to the second suspension position, and is used to acquire the drip rate signal and liquid level signal of the second infusion branch and send them to the electronic control module. The first pipeline blocker is used to be installed on the first infusion branch and is controlled by the electronic control module to open or close the first infusion branch; The second pipeline blocker is used to be installed on the second infusion branch and is controlled by the electronic control module to open or close the second infusion branch; The electronic control module includes a microcontroller and a memory. The memory stores a computer program, which is executed by the microcontroller to implement a finite state machine. The finite state machine assigns mutually exclusive state flags to the first dangling bit and the second dangling bit based on the input of the first barcode scanning unit and / or the second barcode scanning unit. The state flags include at least "in execution" and "pre-stored". The finite state machine generates control commands based on the state identifier and sends them to the first pipeline blocker and the second pipeline blocker respectively: when the first suspension position is marked as being executed, the first pipeline blocker is controlled to release the block. When the first suspension position is marked as pre-stored, the first pipeline blocker is controlled to remain blocked; when the second suspension position is marked as in operation, the second pipeline blocker is controlled to release the blocker. When the second suspension position is marked as pre-stored, the control of the second pipeline blocker remains blocked; the finite state machine allows only one suspension position to be in the execution state at any given time; The finite state machine is prohibited from generating the medical order execution timestamp corresponding to the suspended bit while the suspended bit is marked as pre-stored; the medical order execution timestamp corresponding to the suspended bit is only generated and recorded while the suspended bit is marked as in execution.

2. The infusion management device with mutually exclusive dual mounting positions according to claim 1, characterized in that: The finite state machine only triggers state switching after the dual-channel sensor acquisition module has jointly verified and determined that the liquid has been emptied; The joint verification is as follows: the drip rate signal and liquid level signal collected by the dual-channel sensor acquisition module corresponding to the currently executing suspension position are obtained, and a drain confirmation signal is sent to the finite state machine only when the drip rate signal is lower than the first threshold for N consecutive sampling periods, the liquid level signal is lower than the second threshold, and the changing trends of the drip rate signal and the liquid level signal are positively correlated within a preset time window.

3. The infusion management device with mutually exclusive dual mounting positions according to claim 1, characterized in that: The electronic control module is equipped with an independent hardware security clock chip. The timestamp generated during state switching is stored in the unwritable storage area of ​​the security clock chip in an encrypted format. The finite state machine packages the states before and after the switch, the switch timestamp, and the sensor data sequence that triggered the switch into an indivisible data packet for storage each time a state switch occurs. The electronic control module is also equipped with a wireless communication module, which is used to upload the data packet along with the device's unique hardware code to the hospital information system.

4. The infusion management device with mutually exclusive dual mounting positions according to claim 2, characterized in that: The state identifiers assigned to the first and second suspended bits by the finite state machine also include "idle" and "completed"; the state transition rules of the finite state machine are as follows: The condition for the first or second hanging position to be converted from idle to pre-stored is: the hanging position is scanned and matched by the first or second barcode scanning unit located thereon, and the barcode integrity detection is passed; The condition for the first suspension position to be converted from pre-stored to in execution is: the second suspension position is in execution, and the dual-channel sensor acquisition module corresponding to the second suspension position sends a drain confirmation signal; The condition for the second suspension position to be converted from pre-stored to in execution is: the first suspension position is in execution, and the dual-channel sensor acquisition module corresponding to the first suspension position sends a drain confirmation signal. The condition for the first or second pending position to change from being executed to being completed is: after the state switch is completed, the pending position that was originally being executed will automatically change to being completed; At any given time, only one of the first and second suspension positions is allowed to be in the state of execution.

5. The infusion management device with mutually exclusive dual mounting positions according to claim 1, characterized in that: The finite state machine is also configured with anomaly warning rules; When the drip rate signal is continuously lower than the first threshold, the liquid level signal is not lower than the second threshold, and the changing trends of the drip rate and the liquid level are not related, the finite state machine determines that the path blockage is abnormal, triggers the path blockage warning, maintains the current state unchanged, and does not perform state switching. When the drip rate signal is higher than the third threshold, the liquid level signal is not lower than the second threshold, and the changing trends of the drip rate and the liquid level are not related, the finite state machine determines that the fluid leakage is abnormal, triggers the leakage warning, and controls the pipeline blocker corresponding to the currently executing suspension position to block and prevent the drug solution from continuing to be infused. After the warning is triggered, the finite state machine issues an alarm prompt through the human-machine interaction module and records the abnormality type, trigger time and corresponding sensor data sequence in the memory.

6. The infusion management device with mutually exclusive dual mounting positions according to claim 1, characterized in that: The electronic control module stores a drug incompatibility database or has an interface to call the incompatibility database of the hospital information system; when the finite state machine executes the first suspended position or the second suspended position and switches from idle to pre-stored, it automatically checks whether there is an incompatibility between the drug solution currently being executed and the drug solution to be transferred to the pre-stored suspended position. If there is a conflict, the conversion is rejected. The finite state machine also has a built-in priority scheduling rule. When it is identified that the liquid medicine to be transferred to the pre-stored state has the priority of ST (immediate) or rescue, the currently executing suspended position is paused and the high priority suspended position is switched to execution.

7. The infusion management device with mutually exclusive dual mounting positions according to claim 1, characterized in that: Both the first and second barcode scanning units employ barcode scanning modules to read and decode the drug barcode information on the infusion bag before sending it to the electronic control module.

8. The infusion management device with mutually exclusive dual mounting positions according to claim 1, characterized in that: Both the first and second pipeline stoppers are electric clamp valves.

9. The infusion management device with mutually exclusive dual mounting positions according to claim 1, characterized in that: Both the first dual-channel sensor acquisition module and the second dual-channel sensor acquisition module include an infrared drop count detector and a capacitive liquid level sensor; the infrared drop count detector is used to acquire the drop rate signal, and the capacitive liquid level sensor is used to acquire the liquid level signal.

10. The infusion management device with mutually exclusive dual mounting positions according to claim 1, characterized in that: It also includes a body, on which the first dual-channel sensor acquisition module, the second dual-channel sensor acquisition module, the first pipeline blocker, the second pipeline blocker, and the electronic control module are mounted, and the body is also provided with mounting holes.

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