Sterile intelligent sampling traceability system and method based on internet of things

Abstract

This invention relates to the field of biomedical sampling traceability technology, providing an IoT-based aseptic intelligent sampling traceability system. The system includes a sterile intelligent sampling swab, an intelligent preservation solution container, an edge computing terminal, a cloud management platform, and a mobile verification terminal. These modules work together to achieve aseptic traceability throughout the entire sample collection process. The sterile intelligent sampling swab and the intelligent preservation solution container are uniquely paired via NFC. Opening the tear-off cap of the intelligent preservation solution container generates a physical opening signal, which, combined with the liquid level / temperature sensing signal from a micro-sensor unit, forms dual verification, triggering the traceability process. This system achieves irreversible physical traceability of sample collection, ensuring a unique and sterile binding between the sampling device and the container. It offers high traceability reliability, with core hardware costs below 100 yuan. The system is suitable for aseptic traceability throughout the entire sample collection process in medical and disease control scenarios, and complies with medical traceability regulations.

Description

Technical Field

[0001] This invention relates to the field of biomedical sampling traceability technology, specifically to an aseptic intelligent sampling traceability system and method based on the Internet of Things. Background Technology

[0002] In the biomedical fields such as medicine and disease control, aseptic collection and full-process traceability are core prerequisites for ensuring sample validity, avoiding cross-contamination, and meeting industry regulatory requirements. With the increasing demand for biological sample testing, the requirements for the reliability of sampling devices and storage containers, the tamper-proof nature of container opening, and the authenticity of traceability data are becoming increasingly stringent, directly impacting the accuracy of test results and public health safety.

[0003] Currently, biological sample traceability mainly adopts the traditional screw-cap container combined with electronic tag: the screw-cap container is used to store the sample, and the electronic tag records the sampling-related information to achieve traceability; some solutions record the container opening time through software, but do not form a hardware-level anti-tampering mechanism, and the sampling swab and storage container are independent of each other, without a dedicated aseptic pairing design, relying on manual recording of the association between the sample and the container.

[0004] Existing technologies generally suffer from weak tamper resistance. Traditional screw-cap containers can be opened repeatedly without leaving any trace of operation, and electronic tag data is easily tampered with, lacking physical-level anti-counterfeiting protection. There is no automatic unique binding mechanism between sampling devices and storage containers, making it easy to confuse sample sources and posing a risk of cross-contamination. Traceability often relies on a single signal or software record, which is unreliable and prone to failure due to signal failure or data tampering, failing to meet the stringent requirements for sampling traceability in medical and disease control scenarios. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this invention provides an Internet of Things-based aseptic intelligent sampling traceability system and method, which solves the technical problems of weak anti-tampering properties when containers are opened, low reliability of pairing sampling devices with containers, and easy confusion of sample sources and cross-contamination in existing sampling traceability technologies.

[0006] To achieve the above objectives, the present invention is implemented through the following technical solution: an Internet of Things-based aseptic intelligent sampling traceability system, comprising an aseptic intelligent sampling swab, an intelligent preservation liquid container, an edge computing terminal, a cloud management platform, and a mobile verification terminal, wherein each module works together to achieve aseptic traceability of the entire sample collection process; The sterile smart sampling swab and the smart preservation liquid container are uniquely paired at both ends via NFC. The tear-off cap of the intelligent preservation liquid container generates a physical opening signal, which, together with the liquid level / temperature sensing signal from the micro-miniature sensing unit, forms a dual verification and triggers the traceability process. The intelligent preservation liquid container is connected to the edge computing terminal via a Bluetooth low-power communication module. The edge computing terminal synchronizes data with the cloud management platform, and the mobile verification terminal communicates remotely with the cloud management platform.

[0007] The sterile intelligent sampling swab includes a rod body, an annular stress groove, a swab head, an integrated IoT sensing unit, an offline encrypted storage unit, a sterile code recognition chip, a disposable button-type micro battery, and a near-field communication sensing area; the annular stress groove is located on the upper part of the rod body, and the groove depth is two-thirds of the rod body wall thickness; the swab head uses sterile medical adsorption material, and the disposable button-type micro battery powers all electronic components.

[0008] Preferably, the intelligent preservation liquid container includes a bottle body, a tear-off cap, conductive contacts, an RF antenna, a miniature sensing unit, a Bluetooth Low Energy communication module, a national cryptographic algorithm encryption chip, an offline data storage module, a sterile pairing chip, and a liquid level and temperature warning unit. The conductive contacts are located on the inside of the tear-off cap, with a contact resistance of <1Ω under normal conditions and a gap of >5mm after the tear-off cap is torn open. The RF antenna surrounds the outside of the bottle body, and the miniature sensing unit is an integrated liquid level and temperature sensor that can detect changes in liquid level and temperature in the intelligent preservation liquid container in real time. The liquid level / temperature sensing signal generated by the sensor and the physical opening signal generated by the conductive contacts form a dual verification, synchronously triggering the sampling and traceability process.

[0009] Preferably, the tear-off cover is a one-time irreversible opening structure. After opening, the conductive contacts disconnect, generating a hardware-level physical opening signal that cannot be tampered with or recovered by software, thus preventing secondary sealing fraud.

[0010] Preferably, the national cryptographic algorithm encryption chip works in conjunction with the offline encryption storage unit and the offline data storage module to encrypt, store, and transmit pairing information, physical opening signals, and liquid level / temperature sensing data.

[0011] Preferably, the edge computing terminal is an industrial-grade embedded terminal located at the sampling site, capable of verifying and integrating the integrity and validity of uploaded data, and supporting wired Ethernet and wireless connections for communication; the cloud management platform is built using a cloud server cluster.

[0012] Preferably, the mobile verification terminal includes portable devices such as smartphones and tablets, with a built-in dedicated verification APP that supports identity verification, remote access to cloud data, and viewing full-process traceability data such as sample collection time, location, pairing information, and container status.

[0013] An IoT-based aseptic intelligent sampling and traceability method includes the following steps: Step 1: Establish a unique connection between the sterile smart sampling swab and the smart preservation liquid container through near-field communication to complete the unique sterile binding. The pairing information is encrypted using the national cryptographic algorithm and stored in the local offline storage unit and module. Step 2: After sampling, tear open the tear-off cap. The conductive contacts disconnect, generating a physical opening signal. At the same time, the micro-sensing unit detects the drop in liquid level and temperature change in the container, generating a sensing signal. The dual signals simultaneously trigger the traceability process. Step 3: The smart storage container uploads the encrypted pairing information, physical opening signal, and liquid level / temperature sensor data to the edge computing terminal via Bluetooth Low Energy communication module; Step 4: After the edge computing terminal verifies and integrates the data, it synchronizes it to the cloud management platform for end-to-end encrypted storage and classified management; Step 5: Staff members complete identity verification through the dedicated APP on the mobile verification terminal, remotely access the cloud management platform, and view the sample traceability data throughout the entire process.

[0014] Preferably, in step two, the dual signals must simultaneously satisfy the conditions that the physical activation signal is valid and the sensor signal detects a valid change in order to trigger the traceability process, thereby avoiding traceability errors caused by the failure of a single signal.

[0015] Preferably, the communication distance of the Bluetooth Low Energy communication module in step three is 10m.

[0016] This invention provides a sterile intelligent sampling and traceability system and method based on the Internet of Things (IoT). It has the following beneficial effects: 1. This invention forms a hardware-level physical anti-tampering mechanism through a one-time irreversible tear-off cover and conductive contact design, eliminating the possibility of counterfeiting through secondary sealing; dual signal verification triggers the traceability process, greatly improving traceability accuracy.

[0017] 2. The NFC sterile dual-end unique pairing of the present invention enables automatic binding of sampling swabs and containers without manual intervention, avoiding confusion of sample sources from the outset; the disposable design and debris-free structure effectively prevent cross-contamination.

[0018] 3. This invention achieves fully automated recording of the entire process from pairing, activation, data upload to remote viewing. The data is encrypted and transmitted using national cryptographic algorithms, complying with industry regulations. The cloud management platform has PB-level storage and disaster recovery capabilities.

[0019] 4. The core module of this invention uses standardized electronic components, resulting in low overall hardware costs and making it suitable for large-scale deployment in medical and disease control scenarios. The operation process is simple and convenient, requiring no professional training, and the remote verification function improves work efficiency and reduces labor costs. Attached Figure Description

[0020] Figure 1 is a schematic diagram of the overall system architecture of the present invention; Figure 2 is a cross-sectional view of the sterile intelligent sampling swab structure of the present invention; Figure 3 is a cross-sectional view of the intelligent preservation liquid container structure of the present invention.

[0021] The components include: 1. Sterile intelligent sampling swab; 2. Intelligent preservation liquid container; 3. Edge computing terminal; 4. Cloud management platform; 5. Mobile verification terminal; 11. Rod body; 12. Annular stress groove; 13. Swab head; 14. Integrated IoT sensing unit; 15. Offline encrypted storage unit; 16. Sterile code recognition chip; 17. Disposable button-type micro battery; 18. Near-field communication sensing area; 21. Bottle body; 22. Tear-off cap; 23. Conductive contact; 24. Radio frequency antenna; 25. Micro-miniature sensing unit; 26. Bluetooth Low Energy communication module; 27. National cryptographic algorithm encryption chip; 28. Offline data storage module; 29. ​​Sterile pairing chip; and 30. Liquid level and temperature warning unit. Detailed Implementation

[0022] 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.

[0023] Example: As one aspect of the present invention, please refer to the appendix. Figure 1 - Appendix Figure 3 This invention provides an Internet of Things-based aseptic intelligent sampling and traceability system, comprising: The sterile intelligent sampling swab 1 is a disposable sterile sampling device. The swab head 13 at the top is the biological sample collection end, which is made of sterile medical polyester fiber adsorption material. The rod body 11 is a sterile rigid plastic support structure. The annular stress groove 12 set on the upper part of the rod body 11 facilitates the swab head 13 to be broken without debris after sampling. The integrated IoT sensing unit 14, offline encrypted storage unit 15, and sterile code recognition chip 16 axially integrated inside the rod body 11 are powered by disposable button-type micro battery 17. The near-field communication sensing area 18 on the outside of the rod body 11 cooperates with the sterile pairing chip 29 of the intelligent preservation liquid container 2 to complete the NFC sterile dual-end unique pairing. The pairing information is immediately encrypted by the national cryptographic algorithm and stored in the offline encrypted storage unit 15.

[0024] The intelligent preservation liquid container 2 is a disposable sterile storage container. The bottle body 21 is made of sterile medical transparent PET material. The tear-off cap 22 on the top is a disposable irreversible opening structure. The two conductive metal contacts on the inside of the tear-off cap 22 remain conductive under normal conditions. After tearing, the contacts disconnect, generating an irreversible hardware-level physical opening signal. The radio frequency antenna 24 surrounding the outside of the bottle body 21 can enhance the NFC pairing signal strength and ensure the stability of the pairing connection. The micro-miniature sensing unit 25 integrated inside the bottle body 21 is a high-precision integrated liquid level and temperature sensor, which can detect the drop in liquid level and temperature change in the container in real time. The generated sensing signal and physical opening signal synchronously trigger the traceability process. The liquid level and temperature warning unit 30 provides warnings for the drop in liquid level and temperature change. The national cryptographic algorithm encryption chip 27 encrypts all traceability data. The offline data storage module 28 realizes local encrypted storage. The Bluetooth low power communication module 26 wirelessly uploads the encrypted data to the edge computing terminal 3.

[0025] Edge computing terminal 3, located at the sample collection site, is an industrial-grade embedded terminal. It can receive encrypted data uploaded by intelligent preservation liquid container 2 in real time, perform preliminary verification and integration of the data's integrity and validity, and then synchronize the data with the cloud management platform 4 via wired Ethernet. The cloud management platform 4 is built using a cloud server cluster and has PB-level storage capacity. It can realize encrypted storage, classified management, and real-time updates of the entire sampling traceability data, ensuring data security and accessibility. Mobile verification terminal 5 is a portable device such as a smartphone or tablet with a built-in dedicated verification APP. After completing identity verification through the APP, staff can remotely access the cloud management platform 4 to view the entire traceability data, including the time and location of sample collection, container opening status, swab and container pairing information, and liquid level and temperature changes.

[0026] Mobile verification terminal 5 includes portable devices such as smartphones and tablets, with a built-in dedicated verification APP that supports identity verification, remote access to cloud data, and viewing full-process traceability data such as sample collection time, location, pairing information, and container status. Each module works together to achieve aseptic traceability throughout the sample collection process. The aseptic smart sampling swab 1 and the smart preservation liquid container 2 are uniquely paired at both ends via NFC. The tear-off cap 22 of the smart preservation liquid container 2 generates a physical opening signal, which, together with the liquid level / temperature sensing signal of the micro-miniature sensing unit 25, forms a dual verification and triggers the traceability process. The smart preservation liquid container 2 is connected to the edge computing terminal 3 via the Bluetooth low-power communication module 26. The edge computing terminal 3 synchronizes data with the cloud management platform 4, and the mobile verification terminal communicates remotely with the cloud management platform 4.

[0027] As another aspect of the present invention, embodiments of the present invention provide a sterile intelligent sampling and traceability method based on the Internet of Things, comprising the following steps: Step 1: Establish a unique connection between the sterile smart sampling swab 1 and the smart preservation liquid container 2 through near-field communication to complete the unique sterile binding. The pairing information is encrypted using the national cryptographic algorithm and stored in the local offline storage unit and module. Step 2: After sampling, tear open the tear-off cap 22. The conductive contact 23 disconnects, generating a physical opening signal. At the same time, the micro-sensing unit 25 detects the drop in liquid level and temperature change in the container, generating a sensing signal. The dual signals trigger the traceability process simultaneously. The traceability process is only triggered when both the physical opening signal is valid and the sensing signal detects a valid change, thus avoiding traceability errors caused by the failure of a single signal. Step 3: The smart storage liquid container 2 uploads the encrypted pairing information, physical opening signal, and liquid level / temperature sensing data to the edge computing terminal 3 via the Bluetooth Low Energy communication module 26. The communication distance of the Bluetooth Low Energy communication module 26 is 10m. Step 4: After the edge computing terminal 3 verifies and integrates the data, it synchronizes it to the cloud management platform 4 for end-to-end encrypted storage and classified management; Step 5: Staff members complete identity verification through the dedicated APP on the mobile verification terminal 5, remotely access the cloud management platform 4, and view the full-process traceability data of the sample.

[0028] In actual sampling operations, staff insert the sterile smart sampling swab 1 into the opening of the smart preservation liquid container 2 at the sample collection site. The sterile pairing chip 29 and the near-field communication sensing area 18 establish a dedicated connection via NFC near-field communication, completing a unique sterile dual-end pairing. The pairing information is encrypted and synchronously stored in the local offline storage unit and module. After the staff completes the biological sample collection using the sterile smart sampling swab 1, they tear open the tear-off cap 22 of the smart preservation liquid container 2. The conductive contact 23 disconnects, generating a physical opening signal. At the same time, the micro-sensing unit 25 detects a drop in the liquid level inside the container. The system generates a sensing signal based on slight temperature changes, and these two signals jointly trigger the sampling traceability process. The intelligent preservation liquid container 2 uploads the encrypted NFC pairing information, physical opening signal, and liquid level / temperature sensing data to the edge computing terminal 3 via the Bluetooth Low Energy communication module 26. After preliminary verification and integration of the received data, the edge computing terminal 3 synchronizes the data to the cloud management platform 4 for end-to-end encrypted storage. Staff can remotely access the cloud management platform 4 through the dedicated APP of the mobile verification terminal 5 to view the full-process traceability data of the sample, realizing aseptic traceability and remote verification of sample collection.

[0029] In this embodiment, both the sterile smart sampling swab 1 and the smart preservation liquid container 2 are single-use devices, which are uniformly recycled and destroyed after use, effectively avoiding cross-contamination; the conductive contact 23 has a contact resistance of less than 1Ω under normal conditions, ensuring conductivity stability; after the tear-off cap 22 is torn open, the contact gap is greater than 5mm, ensuring the effective generation of a physical opening signal; the Bluetooth low-power communication module 26 has a communication distance of 10m, and its low-power design enables the container to work for a long time, meeting the actual needs of on-site sampling; the cloud management platform 4 has data backup and disaster recovery functions, which can effectively prevent the loss of traceability data. Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A sterile intelligent sampling and traceability system based on the Internet of Things, characterized in that, It includes a sterile intelligent sampling swab (1), an intelligent preservation liquid container (2), an edge computing terminal (3), a cloud management platform (4), and a mobile verification terminal (5). The modules work together to achieve sterile traceability of the entire sample collection process. The sterile smart sampling swab (1) and the smart preservation liquid container (2) are uniquely paired at both ends via NFC. The tear-off cap (22) of the intelligent preservation liquid container (2) generates a physical opening signal when opened, which, together with the liquid level / temperature sensing signal of the micro-miniature sensing unit (25), forms a dual verification and triggers the traceability process; The intelligent preservation liquid container (2) is connected to the edge computing terminal (3) via Bluetooth low power communication module (26). The edge computing terminal (3) synchronizes data with the cloud management platform (4), and the mobile verification terminal (5) communicates remotely with the cloud management platform (4).

2. The aseptic intelligent sampling and traceability system based on the Internet of Things according to claim 1, characterized in that, The sterile intelligent sampling swab (1) includes a rod (11), an annular stress groove (12), a swab head (13), an integrated Internet of Things sensing unit (14), an offline encrypted storage unit (15), a sterile code recognition chip (16), a disposable button-type micro battery (17), and a near-field communication sensing area (18). The annular stress groove (12) is located on the upper part of the rod (11), and the groove depth is two-thirds of the wall thickness of the rod (11). The swab head (13) is made of sterile medical adsorption material, and the disposable button-type micro battery (17) powers all electronic components.

3. The aseptic intelligent sampling and traceability system based on the Internet of Things according to claim 1, characterized in that, The intelligent preservation liquid container (2) includes a bottle body (21), a tear-off cap (22), conductive contacts (23), an RF antenna (24), a micro-miniature sensing unit (25), a Bluetooth low-power communication module (26), a national cryptographic algorithm encryption chip (27), an offline data storage module (28), a sterile pairing chip (29), and a liquid level and temperature warning unit (30). The conductive contacts (23) are located inside the tear-off cap (22), with a contact resistance of <1Ω under normal conditions and a gap of >5mm after the tear-off cap (22) is torn open. The RF antenna (24) surrounds the outside of the bottle body (21). The micro-miniature sensing unit (25) is an integrated liquid level and temperature sensor that can detect changes in liquid level and temperature in the intelligent preservation liquid container (2) in real time. The liquid level / temperature sensing signal generated by the sensor and the physical opening signal generated by the conductive contacts (23) form a dual verification and simultaneously trigger the sampling and traceability process.

4. The aseptic intelligent sampling and traceability system based on the Internet of Things according to claim 1, characterized in that, The tear-off cover (22) is a one-time irreversible opening structure. After opening, the conductive contact (23) is disconnected, generating a hardware-level physical opening signal that cannot be tampered with or recovered by software, thus preventing secondary sealing fraud.

5. The aseptic intelligent sampling and traceability system based on the Internet of Things according to claim 3, characterized in that, The national cryptographic algorithm encryption chip (27) works in conjunction with the offline encryption storage unit (15) and the offline data storage module (28) to encrypt, store, and transmit pairing information, physical opening signals, and liquid level / temperature sensing data.

6. The aseptic intelligent sampling and traceability system and method based on the Internet of Things according to claim 1, characterized in that, The edge computing terminal (3) is an industrial-grade embedded terminal located at the sampling site. It can perform integrity and validity verification and integration of uploaded data. The communication method supports wired Ethernet and wireless connection. The cloud management platform (4) is built using a cloud server cluster.

7. The aseptic intelligent sampling and traceability system and method based on the Internet of Things according to claim 1, characterized in that, The mobile verification terminal (5) includes portable devices such as smartphones and tablets, with a built-in dedicated verification APP that supports identity verification, remote access to cloud data, and can view full-process traceability data such as sample collection time, location, pairing information, and container status.

8. A sterile intelligent sampling and traceability method based on the Internet of Things, using a sterile intelligent sampling and traceability system based on the Internet of Things as described in any one of claims 1-7, characterized in that, Includes the following steps: Step 1: Establish a unique connection between the sterile smart sampling swab (1) and the smart preservation liquid container (2) through near-field communication to complete the unique sterile binding. The pairing information is encrypted by the national cryptographic algorithm and stored in the local offline storage unit and module. Step 2: After sampling, tear open the tear-off cover (22), the conductive contact (23) disconnects and generates a physical opening signal. At the same time, the micro-miniature sensing unit (25) detects the drop in liquid level and temperature change in the container and generates a sensing signal. The dual signals synchronously trigger the traceability process. Step 3: The intelligent storage container (2) uploads the encrypted pairing information, physical opening signal, and liquid level / temperature sensing data to the edge computing terminal (3) via the Bluetooth Low Energy Communication Module (26). Step 4: After the edge computing terminal (3) verifies and integrates the data, it synchronizes it to the cloud management platform (4) for full-link encrypted storage and classification management; Step 5: Staff members complete identity verification through the dedicated APP of the mobile verification terminal (5), remotely access the cloud management platform (4), and view the sample full-process traceability data.

9. The aseptic intelligent sampling and traceability method based on the Internet of Things according to claim 8, characterized in that, In step two, the dual signals must simultaneously satisfy the conditions of a valid physical activation signal and a valid change detected by the sensor signal in order to trigger the traceability process, thus avoiding traceability errors caused by the failure of a single signal.

10. The aseptic intelligent sampling and traceability method based on the Internet of Things according to claim 8, characterized in that, In step three, the communication distance of the Bluetooth Low Energy communication module (26) is 10m.

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