Small-dose automatic metering, subpackaging and storing device and control method thereof

Abstract

The invention relates to a small-dose automatic metering, subpackaging and storing device and a control method thereof, and relates to the technical field of medical medication configuration and intravenous infusion dosing assistance. The intelligent metering injection unit is arranged in the shell and is used for fixedly mounting a disposable syringe; the piston displacement detection assembly is used for detecting piston displacement in real time; the piston driving and locking mechanism is used for driving the piston of the disposable syringe to automatically shift and be locked at a target dose position; the main control module is used for calculating the actual dose according to the piston displacement; wherein the intelligent metering injection unit provides axial guidance for the disposable syringe, the main control module controls the piston driving and locking mechanism according to the actual dose calculated by the piston displacement detection assembly, and closed-loop metering is achieved. High-precision control over insulin small-dose intravenous dosing can be achieved, the pollution risk caused by pumpback or repeated puncture is avoided, and the actual use loss of insulin injection is reduced on the whole.

Description

Technical Field

[0001] This invention relates to the field of medical drug preparation and intravenous infusion administration technology, and particularly to a device and method for automatic small-dose metering, dispensing, storage and traceable control of insulin injection solution during intravenous infusion administration. It is applicable to intravenous medication preparation centers (PIVAS), ward treatment rooms and other intravenous insulin administration application scenarios. Background Technology

[0002] Currently, insulin injection solutions used clinically are typically supplied in large quantities, such as 400 IU / vial. However, during intravenous infusion, the actual dose used per administration is usually a small range of 1–60 IU. In current practice, healthcare professionals typically use a 1 mL syringe to manually draw the insulin and add it to the infusion fluid. However, this method has the following problems in practical application:

[0003] 1. Insufficient accuracy in small-dose extraction: Because the amount of insulin used is extremely small, manual operation relies on the syringe scale. This is easily affected by factors such as scale resolution, parallax, operator experience, and hand stability, which can lead to large relative errors. 2. Insufficient user experience and stability: When drawing small doses, the syringe piston stroke is short and the damping is large, which can easily lead to rebound, over-injection or insufficient drawing, increasing the risk of medication errors. 3. Risk of contamination: Unused insulin injection solution often requires repeated punctures or aspiration during multiple uses, which can easily introduce the risk of contamination. 4. Significant and difficult-to-quantify drug losses: Due to extraction errors, back-drawing adjustments, syringe residues, and lack of accurate dosage records, drugs are often discarded prematurely, resulting in hidden waste. 5. Lack of traceable evidence in the verification process: Multi-dose insulin bottles are usually reused or discarded after use. The verification process lacks verifiable evidence such as residual liquid and empty bottles, making it difficult to trace the dosage of a single use afterward.

[0004] Therefore, there is an urgent need for a technical solution that can achieve precise small-dose insulin measurement, reduce the risk of contamination, reduce drug loss, and have the ability to trace dosage. Summary of the Invention

[0005] The purpose of this invention is to provide a small-dose automatic metering, dispensing, and storage device for insulin injection and its traceable use control method. This device achieves high-precision control of small-dose intravenous insulin administration without relying on manual visual calibration or verification of residual liquid or empty bottles, avoiding the risk of contamination caused by aspiration or repeated punctures, and reducing the overall actual usage loss of insulin injection.

[0006] To achieve the above objectives, the present invention provides a small-dose automatic metering, dispensing, and storage device, comprising: shell; The intelligent metering injection unit is located inside the housing and is used to securely mount disposable syringes. The piston displacement detection component works in conjunction with the piston push rod of a disposable syringe to detect piston displacement in real time. A piston drive and locking mechanism is used to drive the piston of a disposable syringe to automatically shift and lock at the target dose. The main control module, electrically connected to the piston displacement detection component and the piston drive and locking mechanism, is used to calculate the actual dose based on the piston displacement. The intelligent metering injection unit provides axial guidance for the disposable syringe, and the main control module controls the piston drive and locking mechanism based on the actual dose calculated by the piston displacement detection component to achieve closed-loop metering.

[0007] Preferably, it includes an identification and recording module and a printing module. The identification and recording module is used to generate and store traceable records containing dosage, time, and syringe identification information. The printing module is electrically connected to the main control module and is used to print vouchers containing the release dosage.

[0008] Preferably, the dispensing and storage unit is a disposable syringe. The dispensing and storage unit dispenses the drug solution from the original insulin bottle in one go through a sterile needle and tubing. After dispensing, the fluid connection with the original container is permanently disconnected. The dispensing and storage unit has a self-sealing function.

[0009] Preferably, the intelligent metering injection unit includes a syringe holder and a coaxial guide sleeve. The syringe holder adopts an elastic claw or spiral locking structure, and the guide sleeve is coaxially engaged with the piston rod to limit axial linear movement.

[0010] Preferably, it includes an operation setting module, which includes a touch screen for inputting the target dose.

[0011] Preferably, the piston displacement detection assembly includes a slider connected to the tail end of the piston push rod, a mechanical transmission structure that converts linear displacement into rotational displacement, and an encoder for detecting the rotation angle.

[0012] Preferably, the mechanical transmission structure is a lead screw-nut mechanism or a rack-gear mechanism.

[0013] The technical solution of the present invention also provides a control method for a small-dose automatic metering, dispensing, and storage device, comprising the following steps: Large-volume insulin injection solutions are dispensed into the dispensing and storage unit in a single process through a closed channel. Disconnect the original container and install the dispensing and storage unit into the smart metering injection unit; Start the device to perform initial calibration and set the target insulin dose; The main control module controls the piston drive and locking mechanism to automatically extract the medicine, and the piston displacement detection component detects the piston displacement in real time and calculates the extracted dose. When the target dose is reached, the piston drive and locking mechanism stops and locks the piston position; The identification and recording module automatically generates and stores electronic records containing dosage, time, and syringe identification information; The printing module outputs usage vouchers, enabling dual retention of electronic records and physical vouchers.

[0014] Preferably, the conversion between piston displacement and insulin dose is based on the effective cross-sectional area of ​​the syringe and the amount of piston displacement, and the dose-displacement correspondence curve is determined through experimental calibration.

[0015] Preferably, during automatic extraction, the main control module establishes a conversion relationship between piston displacement and insulin dose based on pre-calibrated syringe specification parameters, accumulates the extracted dose, and decelerates in advance when the dose approaches the target value to prevent overshoot.

[0016] Compared with the prior art, the present invention has at least the following beneficial effects: 1. Achieve high-precision automatic measurement of small doses of insulin; 2. Avoid manual visual measurement of scales to improve medication consistency; 3. Avoid back-pull operations to reduce the risk of contamination; 4. Provide complete usage records to achieve traceable management; 5. Reduce the overall waste of insulin injection solution; 6. Improve the safety and standardization of the intravenous insulin administration process.

[0017] 7. Implement dual retention of electronic records and physical printed vouchers for the intravenous insulin administration process, further enhancing the verifiability and standardization of medication use. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the overall structure of the device in the small-dose automatic metering, dispensing and storage device and its control method of the present invention.

[0019] Reference numerals: 1. Disposable syringe; 2. Operation setting module; 3. Piston displacement detection component; 4. Piston drive and locking mechanism; 5. Printing module. Detailed Implementation

[0020] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0021] This invention discloses a small-dose automated metering, dispensing, and storage device for insulin injection. The device features an integrated axial structure design, with functional modules arranged sequentially along the main axis to form a compact and operational form. The device mainly includes a main body shell, an intelligent metering injection unit, a piston displacement detection component 3, a piston drive and locking mechanism 4, a main control module, an operation setting module 2, an identification and recording module, a dispensing and storage unit, and a printing module 5. These components work together to achieve a sealed transfer of insulin injection from the original large-sized container to the disposable dispensing unit, as well as high-precision automated metering and traceable control during subsequent small-dose extraction.

[0022] The main casing of the device serves as the supporting structure, and its internal space is rationally divided into three main functional areas: a syringe mounting area, a displacement detection and drive area, and a main control area. The syringe mounting area is located at the front of the device and is used to fix and position the disposable syringe 1. The displacement detection and drive area is located in the middle and is used to install the piston displacement detection component 3 and the piston drive and locking mechanism 4. The main control area is located at the rear and houses the main control module, power supply, and related circuitry. The casing can be made of metal or high-strength engineering plastic injection molding to ensure sufficient mechanical strength and stability of the overall structure. The surface is designed to be smooth and seamless for easy cleaning and disinfection after clinical use.

[0023] The intelligent metering injection unit is used to mount the disposable syringe 1 and provides precise and stable guidance for the axial movement of the syringe piston. This unit includes a syringe holder and a guide sleeve. The syringe holder securely clamps the syringe barrel 1, preventing rotation or lateral displacement during extraction. The guide sleeve is coaxially fitted with the syringe piston push rod, ensuring that the piston moves linearly only in the axial direction. This eliminates displacement deviations caused by improper operation and lays the mechanical foundation for subsequent accurate metering.

[0024] The piston displacement detection component 3 is positioned along the movement path of the syringe piston rod. Its main function is to detect the actual displacement of the piston in real time and output the corresponding detection signal. This component includes a sliding member that cooperates with the piston rod, a mechanical transmission structure, and an encoder. The sliding member is directly connected to the tail end of the piston rod and moves synchronously with the piston. The mechanical transmission structure can employ a screw-nut mechanism or a rack-gear mechanism to convert the linear displacement of the piston rod into rotational displacement. The encoder is connected to the rotating shaft of the mechanical transmission structure to detect the rotation angle and output a pulse signal. Through this conversion, the tiny linear displacement of the piston is amplified into a precisely measurable change in rotational angle, significantly improving the resolution and accuracy of displacement detection. Simultaneously, a guide structure and a limiting structure are provided along the movement path of the piston displacement detection component 3. The guide structure uses a linear guide rail or a groove to ensure smooth, wobbly movement of the sliding member. The limiting structure is used to set the maximum stroke range of the piston, preventing damage to the syringe or exceeding the dosage limit due to misoperation.

[0025] The piston drive and locking mechanism 4 is electrically connected to the main control module. Under the control of the main control module, it drives the syringe piston to move automatically and automatically stops or locks when it reaches the target dose position. This mechanism may include a micro stepper motor or servo motor, a reduction gear set, and an electromagnetic locking device. The motor is connected to the mechanical transmission structure through the reduction gear set to achieve high-precision, low-speed piston drive. The electromagnetic locking device activates immediately when the motor stops working, locking the piston position to prevent piston rebound or displacement due to internal syringe pressure or external interference, thereby ensuring the accuracy and stability of the extracted dose. This integrated drive and locking design achieves both the convenience of automatic extraction and the reliability of dose retention.

[0026] The main control module, as the core control unit of the device, receives displacement detection signals from the encoder, calculates the extracted insulin dose using a built-in algorithm, and sends control commands to the piston drive and locking mechanism 4 according to the preset target dose, thereby achieving automatic small-dose insulin delivery control. The main control module includes a microprocessor, memory, signal processing circuitry, and power management circuitry. The microprocessor can run existing embedded control programs to perform functions such as dose calculation, motor control, data storage, and communication management; the memory stores system parameters, calibration data, and dosage records; the signal processing circuitry filters and counts the pulse signals output by the encoder; and the power management circuitry provides a stable operating voltage for each module. The main control module establishes a conversion relationship between piston displacement and dose based on the specifications of the syringe used, calculated based on the effective cross-sectional area of ​​the syringe and the amount of piston displacement.

[0027] The operation setting module 2 is used to input the target insulin dose and trigger the automatic metering command. This module includes a touchscreen. Operators can directly set the target dose value via the touchscreen; the dose value is displayed and input in International Units (IU). Operation setting module 2 also has a start button and an emergency stop button. The start button triggers the automatic dispensing program, and the emergency stop button immediately interrupts the operation in case of abnormalities. The touchscreen can display the currently set target dose, the dose dispensed, the system status, and prompts in real time, providing operators with an intuitive human-machine interface.

[0028] The identification and recording module generates and stores dosage records corresponding to each insulin withdrawal operation, enabling long-term preservation and traceability of dosage information. This module includes non-volatile memory and a real-time clock circuit. After each withdrawal operation, it automatically records the release dose, operation time, syringe number, or identification information. The syringe number can be obtained through barcode scanning, RFID identification, or manual input, ensuring that the usage history of each syringe can be uniquely identified and tracked. The recording module uses a circular storage method, automatically overwriting the oldest record when the storage space is full. It also supports exporting recorded data to an external management system via USB interface or wireless communication.

[0029] The dispensing and storage unit is a disposable syringe 1 that can be installed in the intelligent metering injection unit. After completing the one-time dispensing connection with the original insulin injection bottle, this syringe independently and in a sealed manner stores the insulin injection solution and serves as the sole storage and release unit for the drug solution during subsequent use. The dispensing and storage unit adopts a sterile reservoir, reservoir cylinder, or a dedicated syringe structure designed to match the intelligent metering injection unit. The dispensing and storage unit is connected to the original insulin bottle through a sealed passage using a sterile needle and sterile tubing to ensure that the dispensing process is completed under completely sealed conditions. After dispensing, the fluid connection between the syringe and the original drug container is permanently disconnected, and all subsequent extraction operations are performed from this dispensing and storage unit, thereby completely avoiding the risk of contamination from repeated punctures of the original drug container.

[0030] Printing module 5 is electrically connected to the main control module and is used to automatically print the corresponding dosage information label or record voucher after the completion of the insulin quantitative release operation. Printing module 5 can use a miniature thermal printer, and the printed content includes at least the release dose, operation time, syringe number, or identification information. The printed label or voucher can be affixed to the surface of the infusion bag, the medical record sheet, or stored in a dedicated review file as physical evidence of medication use for post-event verification and accountability. This achieves dual retention of electronic records and physical vouchers, further enhancing the verifiability and standardization of the medication process.

[0031] The following is a detailed description of the manufacturing process of the small-dose automatic metering, dispensing, and storage device for insulin injection described in this invention: 1. Fabrication of the main structure of the device: Fabricate a main casing for installing and supporting the various functional modules. The interior of the casing is divided into a metering injection unit installation area (i.e., displacement detection and drive area), a main control module installation area (i.e., main control area), and a dispensing and storage unit connection area (i.e., syringe installation area). The casing can be made of metal or high-strength engineering plastic, and its structure should meet the requirements of stability and ease of cleaning and disinfection.

[0032] 2. Assembly of the Intelligent Metering Injection Unit: A syringe holder is installed in the metering injection unit mounting area of ​​the main body shell of the device. This holder can adopt an elastic claw or screw locking structure to adapt to different specifications of disposable syringe barrel diameters, ensuring the syringe remains stable in the axial direction. A piston displacement detection component 3 is installed on the movement path of the syringe piston rod. The mechanical transmission structure adopts a precision lead screw-nut mechanism, with the nut and sliding component integrally formed. A linear guide rail is set on the movement path of the piston displacement detection component 3 as a guiding structure. The length of the guide rail is 1.2 times the full stroke of the syringe, ensuring a smooth and jam-free displacement detection process. At the same time, mechanical limit switches are set at both ends of the guide rail as a safety limit structure to prevent overtravel.

[0033] 3. Installation of the main control module and peripheral modules: Install the main control module in the main control area of ​​the device's main casing. Electrically connect the encoder's signal output terminal to the main control module's signal input interface, enabling the main control module to receive and process piston displacement signals. Install operation setting module 2 for inputting target insulin dose parameters; the touchscreen also facilitates operation and observation. Install a prompt module for outputting audible, visual, or other forms of prompt signals. All modules are installed using a modular plug-in method for easy maintenance and replacement.

[0034] 4. Configuration of the Dispensing and Storage Unit: A sealed dispensing and storage unit is configured. This unit can adopt a sterile soft reservoir or a rigid reservoir structure. The reservoir is made of medical-grade silicone material, and the reservoir is made of medical-grade polypropylene material. The dispensing and storage unit is connected to the original insulin injection bottle through sterile connecting tubing and a puncture needle, ensuring smooth drug delivery and minimal residual amount. After dispensing, the dispensing and storage unit is connected to the intelligent metering injection unit and has a self-sealing function. It can automatically seal after disconnection to prevent drug leakage and external contamination.

[0035] 5. System Debugging and Calibration: After the device is assembled, connect the power and start the system. Perform zero-point calibration on the piston displacement detection component 3, that is, reset the encoder count to zero when the syringe piston is fully retracted. Establish the conversion relationship between piston displacement and insulin dose based on the specifications of the syringe used, such as the inner diameter and effective cross-sectional area of ​​the syringe. This relationship is determined through experimental calibration, i.e., measuring the piston displacement at a known dose, establishing a dose-displacement curve, and saving it in the main control module's memory. After completing the above debugging and initial calibration, the device is ready for use.

[0036] The automatic metering, dispensing, and storage device for small-dose insulin injection described in this invention is used in practice according to the following steps: 1. Dispensing preparation: Dispense the large-volume insulin injection solution into the dispensing and storage unit in one go through a closed channel. After dispensing, immediately disconnect the fluid connection between the dispensing and storage unit and the original insulin injection bottle, and install the dispensing and storage unit onto the mounting base of the intelligent metering injection unit, making it the sole source of medication for subsequent extraction operations.

[0037] 2. Device Initialization: Press the power switch to start the device. The main control module performs a self-test to check whether the working status of each module is normal. Then, an initialization calibration is performed to confirm whether the zero point position of the piston displacement detection component 3 is accurate. If necessary, the zero point calibration procedure is re-executed. After initialization, the device enters standby mode, and the touch screen displays a ready message, prompting that the target dose can be set.

[0038] 3. Target Dose Setting: Input the target insulin dose required for this intravenous administration via the buttons or touchscreen of the operation setting module 2. The dose value is in International Units (IU). After inputting the dose, press the confirmation button. The target dose value will be displayed on the touchscreen and simultaneously stored in the temporary register of the main control module, awaiting the extraction operation.

[0039] 4. Small-dose extraction: Connect the disposable syringe 1 to the dispensing and storage unit, then press the start button. The main control module controls the piston drive and locking mechanism 4 to start working, driving the syringe piston to move and perform the insulin extraction operation. During the piston movement, the syringe piston displacement is detected in real time, and the main control module counts and calculates, calculating the extracted insulin dose in real time and displaying the current dose value on the LCD screen.

[0040] 5. Dosage Reaching Indication and Stop: When the measured dose reaches or approaches the set target dose, the piston movement automatically stops, completing the insulin dispensing. The indicator module issues a signal to notify the operator that dispensing is complete and the insulin administration is finished.

[0041] 6. Recording and Verification: The device automatically generates and saves the insulin usage record immediately after extraction for subsequent dosage verification and traceability.

[0042] 7. Printing and Retention: After completing the quantitative release of insulin and generating a dosage record, the device outputs the corresponding dosage record voucher through the printing module 5. The printed voucher can be pasted on the surface of the infusion bag, the medical record sheet, or retained in a special review file as physical evidence of medication use for subsequent verification and accountability.

[0043] This invention proposes an automatic metering, dispensing, and storage control method for small-dose insulin based on syringe piston displacement detection. Using the actual displacement of the syringe piston as the basic metering variable, the method achieves closed-loop control of the small-dose insulin extraction process through real-time detection, cumulative calculation, and target comparison, and generates traceable dosage records.

[0044] This invention detects the actual displacement of the syringe piston and converts the mechanical displacement during the extraction process into a corresponding insulin dose, thereby avoiding errors caused by manual visual calibration. By setting up a dispensing and storage unit, large-volume insulin injection solutions are dispensed only once, avoiding the risk of contamination caused by subsequent re-drawing or repeated puncture of the original drug container. By automatically measuring and recording each small-dose extraction process, a complete chain of dosage evidence is formed, enabling dosage verification and traceability even when there is no residual liquid or empty bottle.

[0045] Finally, it should be noted that the above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A small-dose automatic metering and dispensing storage device, characterized by, The application relates to a smart metering injection device, comprising: a housing; a smart metering injection unit arranged in the housing for fixedly mounting a disposable syringe; a piston displacement detection assembly cooperating with a piston rod of the disposable syringe for real-time detection of piston displacement; a piston driving and locking mechanism for driving the piston of the disposable syringe to automatically displace and lock at a target dose; a main control module electrically connected with the piston displacement detection assembly and the piston driving and locking mechanism for calculating an actual dose according to the piston displacement; wherein the smart metering injection unit provides axial guidance for the disposable syringe, and the main control module controls the piston driving and locking mechanism according to the actual dose calculated by the piston displacement detection assembly to realize closed-loop metering.

2. A small-dose automatic metering and dispensing storage device according to claim 1, characterized in that, The device comprises an identification and recording module and a printing module, the identification and recording module is used for generating and storing a traceable record containing a dose, a time and syringe identification information, and the printing module is electrically connected with the main control module and is used for printing a voucher containing a released dose.

3. A small-dose automatic metering and dispensing storage device according to claim 2, characterized in that, A split storage unit is used for the disposable syringe, the split storage unit is used for one-time split storage of a medicine liquid from an original insulin bottle through a sterile needle and a pipeline, the split storage unit is permanently disconnected from the original container after split storage is completed, and the split storage unit has a self-sealing function.

4. The small-dose automatic metering and sub-packaging storage device according to claim 2, characterized in that, The smart metering injection unit comprises a syringe fixing seat and a coaxial guide sleeve, the syringe fixing seat adopts an elastic clamping jaw or a screw locking structure, and the guide sleeve is coaxially matched with the piston rod to limit axial linear movement.

5. A small-dose automatic metering and dispensing storage device according to claim 2, characterized in that, The device comprises an operation setting module, and the operation setting module comprises a touch screen used for inputting a target dose.

6. A small-dose automatic metering and sub-packaging storage device according to claim 2, characterized in that, The piston displacement detection assembly comprises a sliding piece connected with a tail end of the piston rod, a mechanical transmission structure for converting linear displacement into rotary displacement and an encoder for detecting a rotary angle.

7. A small-dose automatic metering and dispensing storage device according to claim 6, characterized in that, The mechanical transmission structure is a screw nut mechanism or a rack and pinion mechanism.

8. A control method for a small-dose automatic metering and dispensing storage device according to any one of claims 2 to 7, characterized in that, The device comprises the following steps: large-specification insulin injection liquid is one-time split stored into a split storage unit through a sealed channel; connection with an original container is disconnected, and the split storage unit is mounted to the smart metering injection unit; the device is started to perform initialization calibration, and a target insulin dose is set; the main control module controls the piston driving and locking mechanism to automatically extract a medicine liquid, the piston displacement detection assembly detects piston displacement in real time and calculates an extracted dose; when the target dose is reached, the piston driving and locking mechanism is stopped and the piston position is locked; an identification and recording module automatically generates and stores an electronic record containing a dose, a time and syringe identification information; a printing module outputs a dose voucher to realize double storage of electronic records and physical vouchers.

9. The small dose automatic metering and dispensing storage control method according to claim 8, wherein, Conversion of piston displacement and insulin dose is calculated based on an effective sectional area of the syringe and an amount of piston displacement, and a dose-displacement corresponding curve is determined through experimental calibration.

10. The small dose automatic metering and dispensing storage control method according to claim 9, wherein, During automatic extraction, the main control module establishes a conversion relationship between piston displacement and insulin dose according to pre-calibrated syringe specification parameters, accumulatively calculates an extracted dose, and slows down in advance when the dose approaches a target value to prevent overshoot.

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