Salivary pH dynamic monitoring and oral care prompting device

CN122983167APending Publication Date: 2026-10-27高佳芳
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Patent Information

Application Number
CN202611178513.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-08-05
Publication Date
2026-10-27

AI Technical Summary

Technical Problem

[0004]现有唾液pH检测装置多侧重于获得单次检测结果,采集部件、检测部件和数据处理部件之间缺少适用于床旁护理的固定安装关系;部分装置的可重复使用检测元件直接接触不同患者的唾液样本,增加清洁消毒工作量;同时,现有装置对安装状态、电触点连接、一次性传感元件校准参数、主机自检状态和检测稳定性的综合判断不足,可能将无效或受干扰的数据纳入历史趋势

Benefits of technology

[0025]第二,pH敏感元件31、参比电极34和温度补偿元件32的敏感区域位于最低有效液位以下并位于溢流入口以下,使检测区域在最低有效样本量下被充分覆盖,同时保持不同检测中的浸没状态相对一致。

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Abstract

The present application relates to medical care monitoring device technical field, disclose a kind of saliva pH dynamic monitoring and oral care prompting device, including detection host computer and detachable disposable saliva collection component.Collecting component is equipped with quantitative detection cavity, closed overflow cavity, backflow baffle, pH sensitive element, reference electrode, temperature compensation element, calibration information carrier and detection interface with electrical contact;Host computer mounting groove is equipped with guiding structure, installation in place detection piece and host computer electrical contact.Only when component is installed in place, electrical contact is conducted and calibration parameter reading is effective, host computer collects the potential difference signal between pH sensitive element and reference electrode, completes calibration conversion, temperature compensation, stability and effectiveness determination, effectively stores the result in association with patient identification and detection time, and outputs retest or manual reevaluation prompt.The device can unify sampling quantity and sensing position, isolate patient sample and reduce invalid data into trend record.
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Description

[0001] This invention relates to the field of medical and nursing monitoring devices, specifically to a saliva pH dynamic monitoring and oral care prompt device that performs quantitative collection of saliva samples, pH and temperature detection, calibration parameter reading, validity determination, multi-time point result association storage, and nursing prompt information output. Background Technology

[0002] During anti-tumor therapy, pretreatment for hematopoietic stem cell transplantation, and other high-intensity treatments, patients may experience oral mucosal erythema, edema, erosion, ulceration, pain, dry mouth, and difficulty eating. Clinically, nursing assessments typically combine oral visual examination, oral mucosal assessment scales, and pain scores. However, these assessments are easily affected by the observation time point, the assessor's experience, and the patient's ability to express themselves. Therefore, objective and repeatable auxiliary indicators are needed.

[0003] Saliva pH reflects changes in the acidity or alkalinity of the oral microenvironment, but a single test is easily affected by factors such as eating, drinking, brushing teeth, rinsing, topical medication, sample volume, testing time, and testing location. Current bedside testing typically uses a collection container, pH test strips or a portable pH meter, timing tools, and nursing record sheets. Different operators may have inconsistent control over the sample volume, sensor contact position, and stabilization time, and test results may be missed, incorrect, or mismatched with patient information.

[0004] Existing saliva pH testing devices mostly focus on obtaining single test results, lacking a fixed installation relationship suitable for bedside care between the collection, detection, and data processing components. In some devices, reusable detection elements directly contact saliva samples from different patients, increasing the workload of cleaning and disinfection. Furthermore, existing devices lack comprehensive judgment regarding installation status, electrical contact connections, disposable sensor calibration parameters, main unit self-test status, and detection stability, potentially including invalid or interfered data in historical trends. Therefore, a nursing aid device is needed that can standardize sample volume and sensor location, isolate patient samples, automatically identify component installation status, read disposable sensor calibration parameters, screen valid test results, and generate continuous records. Summary of the Invention

[0005] The present invention aims to solve the problems in the prior art, such as inconsistent saliva sample collection volume and detection location, easy overflow or backflow of excessive samples, risk of cross contact of sensing elements, lack of reliable positioning and installation identification of disposable components and detection host, unclear source of reference potential and calibration parameters of disposable sensing elements, insufficient judgment of detection stability and effectiveness, and difficulty in accurately correlated multi-time point detection results with patients and detection time. Technical solution

[0006] To address the aforementioned technical problems, the present invention provides a saliva pH dynamic monitoring and oral care reminder device, comprising a reusable detection host 1 and a disposable saliva collection component 2 detachably connected to the detection host 1.

[0007] The disposable saliva collection assembly 2 includes a saliva inlet 25, a collection chamber 21, a flow guiding structure 22, a quantitative marking structure 23, a quantitative detection chamber 26, an overflow chamber 27, a top cover 28, an anti-backflow baffle 29, a detection interface 24, and a calibration information carrier 245. The saliva inlet 25 communicates with the collection chamber 21. The flow guiding structure 22 contracts from the bottom of the collection chamber 21 towards the quantitative detection chamber 26, allowing saliva entering the collection chamber 21 to flow along a fixed path into the quantitative detection chamber 26. The quantitative marking structure 23 is located on the side wall of the quantitative detection chamber 26 and is used to indicate the minimum effective liquid level and the preset maximum liquid level.

[0008] The overflow chamber 27 is located on the side of the quantitative detection chamber 26, with the lower edge of the overflow inlet flush with the preset maximum liquid level. When the sample in the quantitative detection chamber 26 reaches the preset maximum liquid level, subsequent samples enter the overflow chamber 27 through the overflow inlet. The overflow chamber 27 is a closed side chamber, and a check valve or a labyrinth-type backflow blocking structure can be installed at the overflow inlet to reduce the amount of overflow sample returning to the quantitative detection chamber 26 when the device is moved.

[0009] A backflow prevention baffle 29 is located below the saliva inlet 25, with one end rotatably or flexibly connected to the inner wall of the collection chamber 21. The baffle 29 opens when saliva flows in the inlet direction; when the device tilts or moves, the baffle 29 adheres to the stop surface under its own weight, elastic restoring force, or liquid back pressure to reduce sample backflow into the saliva inlet 25. A top cover 28 is used to seal the saliva inlet 25 after sampling, and a sealing ring is provided between the top cover 28 and the saliva inlet 25.

[0010] The pH sensing element 31, reference electrode 34, and temperature compensation element 32 are fixedly disposed at predetermined detection positions within the quantitative detection chamber 26. The pH sensing element 31 can be a solid-state electrochemical pH working electrode or an ion-sensitive field-effect transistor sensing element, the reference electrode 34 can be a solid-state reference electrode, and the temperature compensation element 32 can be a thermistor. The pH sensing element 31 and the reference electrode 34 can be discrete structures or packaged within the same sensor substrate. The sensitive areas of all three are located below the minimum effective liquid level and below the overflow inlet, ensuring that the detection area is fully covered when the sample reaches the minimum effective amount, and that excess sample enters the overflow chamber 27 after the sample reaches the preset maximum liquid level.

[0011] The pH-sensitive element 31, reference electrode 34, and temperature compensation element 32 are connected to the component electrical contacts 244 at the detection interface 24 via conductors embedded in the wall of the disposable saliva collection assembly 2. This allows the sensing element and the disposable saliva collection assembly 2 to jointly form a disposable detection unit, preventing reusable components in the detection host from directly contacting the patient's saliva. The signal conversion unit 33 obtains the pH detection signal based on the potential difference between the pH-sensitive element 31 and the reference electrode 34, and simultaneously acquires the sample temperature signal output by the temperature compensation element 32.

[0012] The detection interface 24 includes an anti-rotation guide 241, a limiting shoulder 242, an elastic seal 243, and a component electrical contact 244. The anti-rotation guide 241 has a D-shaped cross-section, a circular cross-section with a plane, or a non-circular cross-section with a keyway. The limiting shoulder 242 is an outwardly expanding step located on the outer periphery of the detection interface 24. The elastic seal 243 surrounds the anti-rotation guide 241 and is located between the limiting shoulder 242 and the component electrical contact 244. The connection between the detection interface 24 and the quantitative detection chamber 26 is integrally molded or sealed to reduce sample leakage into the electrical contact area.

[0013] The component electrical contacts 244 include sensing signal contacts and calibration information contacts. The calibration information carrier 245, which may be a non-volatile memory, an coded resistor, or other electronic identification unit readable by the testing host, stores the factory calibration parameters, batch identifier, and applicable range of the disposable testing unit, and connects to the testing host via the calibration information contacts. The factory calibration parameters may include at least one of zero-point parameters, slope parameters, temperature compensation parameters, and batch correction parameters.

[0014] The detection host 1 includes a detection host housing 11, operation buttons 12, a patient information reading interface 13, a mounting slot 14, a signal conversion unit 33, a data processing module 4, a display and prompt module 5, a power supply module 6, and a detection timing module 7. The mounting slot 14 contains a guide structure 141 adapted to the anti-rotation guide part 241, a stop surface cooperating with the limiting shoulder 242, an installation positioning detection element 142, and host electrical contacts 143. When the disposable saliva collection component 2 is inserted along the guide structure 141 until it abuts against the limiting shoulder 242 and the stop surface, the component electrical contacts 244 and host electrical contacts 143 are pressed together and connected, and the installation positioning detection element 142 outputs an installation positioning signal. The installation positioning detection element 142 can be a micro switch, a Hall sensor and magnetic component, a photoelectric detection structure, or a conductive contact closure structure.

[0015] The signal conversion unit 33 enters the detection sampling state and the detection timing module 7 starts timing only when the installation signal, the conduction state of component electrical contact 244 and host electrical contact 143, and the factory calibration parameter reading state are all valid. If any state is invalid, the data processing module 4 does not generate a valid detection result and outputs the corresponding status prompt through the display prompt module 5.

[0016] The signal conversion unit 33 is connected to the main unit's electrical contacts 143 and is used to amplify, filter, and perform analog-to-digital conversion on the potential difference signal between the pH-sensitive element 31 and the reference electrode 34, as well as the output signal of the temperature compensation element 32. The data processing module 4 converts the potential difference signal into a pH value based on the factory calibration parameters provided by the calibration information carrier 245 and performs temperature compensation. The internal calculation resolution of the signal conversion unit 33 is preferably not less than 0.01 pH units, and the display screen 51 can display in 0.1 pH units so that the device can use internal sampling values ​​higher than the display resolution to complete the stability judgment.

[0017] The data processing module 4 includes a data storage unit 41, a time stamping unit 42, a trend analysis unit 43, a patient information association unit 44, and a validity determination unit 45. The validity determination unit 45 generates valid or invalid markers based on the installation completion signal, the conduction status of the component electrical contact 244 and the host electrical contact 143, the factory calibration parameter reading status, the host self-test status, whether the detection signal is within the preset range, and the stability judgment result. Detection results with invalid markers can be saved for equipment maintenance traceability but are not included in dynamic trend calculations.

[0018] The self-test of the main unit includes testing at least one of the following: signal conversion unit 33, power supply voltage, open or short circuit status of main unit electrical contacts 143, and internal standard signal response status. The main unit 1 can use a standard signal to calibrate the signal conversion unit 33 according to a preset self-test cycle prompt; the disposable test unit is factory calibrated and does not need to be recalibrated during clinical use.

[0019] The timing module 7 starts timing after the installation signal, electrical contact conduction status, and factory calibration parameter reading status are all valid. The signal conversion unit 33 continuously acquires internal sample values ​​according to the preset sampling frequency; when the difference between the maximum and minimum values ​​of multiple internal sample values ​​within the preset stabilization time is not greater than the preset stabilization threshold, the data processing module 4 determines that the result is stable. If the stabilization condition is not reached within the preset maximum detection time, the display prompt module 5 outputs a status prompt indicating the sample quantity to be checked, the connection of the inspection component, or the replacement of the disposable detection unit.

[0020] The patient information reading interface 13 is used to read or input patient identifiers, and can be a barcode reader, a near-field communication reader, or a manual input interface. The patient information association unit 44 associates and saves valid test results, sample temperature, test date, test time, treatment stage markers, and sampling condition markers entered by nursing staff with the patient identifiers.

[0021] The trend analysis unit 43 selects valid detection results as the representative value for each observation day within a preset detection time window. If only one valid detection result exists within the time window, that result is used; if multiple valid detection results exist, the median is used. Data marked as indicating component not installed correctly, abnormal contact connection, abnormal calibration parameter reading, abnormal host self-test, exceeding the detection range, not reaching stable conditions, or sampling conditions being interfered with are not included in the representative value calculation. The trend analysis unit 43 compares the representative values ​​for multiple consecutive observation days with the individual baseline value, the previous representative value, and a preset attention threshold to generate a dynamic change state of stable, declining, below the attention threshold, or continuously abnormal.

[0022] The display and prompt module 5 includes a display screen 51, a status indicator unit 52, and a nursing prompt unit 53. The display screen 51 displays the current valid test results, test time, historical representative values, and dynamic changes in status. The status indicator unit 52 displays statuses such as standby, component installation, test in progress, stable results, connection abnormality, calibration parameter reading abnormality, host self-test abnormality, or test timeout. The nursing prompt unit 53 calls a preset prompt template based on the dynamic changes in status and outputs prompts for continued monitoring, retesting at a specified time, reassessment of the artificial oral cavity status, or adjustment of monitoring frequency. These prompts do not constitute a disease diagnosis and do not automatically generate medication orders.

[0023] The power supply module 6 provides power to the signal conversion unit 33, the data processing module 4, the display and prompt module 5, the detection and timing module 7, and the installation-in-place detection component 142. The power supply module 6 can use a rechargeable battery or an external low-voltage power supply, and is equipped with power monitoring and low-power prompts. Beneficial effects

[0024] First, a fixed flow path is formed by the collection chamber 21, the flow guiding structure 22, the quantitative detection chamber 26 and the closed overflow chamber 27. The lower edge of the overflow inlet is flush with the preset maximum liquid level. After reaching the preset maximum liquid level, it can accommodate excess samples, which is conducive to uniformly detecting the amount of samples and reducing overflow.

[0025] Second, the sensitive areas of the pH sensing element 31, the reference electrode 34, and the temperature compensation element 32 are located below the minimum effective liquid level and below the overflow inlet, so that the detection area is fully covered at the minimum effective sample volume, while maintaining a relatively consistent immersion state in different detections.

[0026] Third, the pH-sensitive element 31, reference electrode 34, temperature compensation element 32, calibration information carrier 245, and component electrical contact 244 are all located in the disposable saliva collection component 2, which can isolate the patient's saliva sample from the reusable components in the detection host and provide traceable factory calibration parameters for each disposable detection unit.

[0027] Fourth, the anti-rotation guide 241, the limiting shoulder 242, the elastic seal 243, the guide structure 141, the stop surface, the electrical contact, and the installation position detection component 142 jointly define the insertion direction, installation depth, sealing state, and electrical connection state of the component; it only enters the detection sampling state when the component is installed in place, the contact is on, and the calibration parameter reading is valid.

[0028] Fifth, internal sampling values ​​higher than the display resolution are used for calibration conversion, temperature compensation, and stability judgment. Valid markers are generated based on installation status, connection status, calibration parameter reading status, host self-test status, range, and stability, which helps to prevent invalid data from entering historical trends.

[0029] Sixth, by linking patient information, determining daily representative values, and generating dynamic status, results from multiple time points can be saved and compared according to unified rules; the prompting unit only outputs process prompts such as retesting and manual review, which can provide auxiliary information for nursing staff without replacing clinical diagnosis and treatment judgment. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the overall structure of the device provided in an embodiment of the present invention; Figure 2 The diagram shows the exploded structure, longitudinal section, assembly structure, and partial cross-sectional view of the disposable saliva collection component provided in the embodiments of the present invention, as well as its cooperation with the mounting groove. Figure 3 This is a block diagram showing the connection of functional modules of the device provided in an embodiment of the present invention; Figure 3 Solid lines with arrows indicate the direction of signal transmission, while solid lines without arrows indicate power supply connections.

[0031] Explanation of reference numerals in the attached drawings: 1. Detection host; 11. Detection host housing; 12. Operation buttons; 13. Patient information reading interface; 14. Mounting slot; 141. Guide structure; 142. Installed detection component; 143. Host electrical contact; 2. Disposable saliva collection component; 21. Collection chamber; 22. Flow guiding structure; 23. Quantitative marking structure; 24. Detection interface; 241. Anti-rotation guide; 242. Limiting shoulder; 243. Elastic seal; 244. Component electrical contact; 245. Calibration information carrier; 25. Saliva inlet; 26. Fixed... 27. Quantity detection chamber; 28. Overflow chamber; 29. ​​Top cover; 30. Anti-backflow baffle; 41. pH detection module; 52. pH sensitive element; 63. Temperature compensation element; 74. Signal conversion unit; 85. Reference electrode; 9. Data processing module; 10. Data storage unit; 11. Time stamping unit; 12. Trend analysis unit; 13. Patient information association unit; 14. Effectiveness determination unit; 15. Display prompt module; 16. Display screen; 27. Status indication unit; 28. Nursing prompt unit; 39. Power supply module; 40. Detection timing module. Detailed Implementation

[0032] The structure and operation of the present invention will be further described below with reference to the accompanying drawings. The following embodiments are for illustrative purposes only and are not intended to limit the scope of protection of the present invention. Without departing from the concept of the present invention, the dimensions, materials, sensing element forms, calibration information carrier forms, and threshold parameters of each structure can be adjusted according to actual product requirements.

[0033] See Figure 1 The detection host 1 adopts a desktop or portable housing structure. The upper part of the housing 11 is equipped with a display screen 51, a status indicator unit 52, and a nursing prompt unit 53, while the lower part is equipped with operation buttons 12, a patient information reading interface 13, and a mounting slot 14. The disposable saliva collection component 2... Figure 1 Insert the component into the mounting slot 14 in the indicated direction. The opening contour of the mounting slot 14 matches the shape of the detection interface 24, which can prevent the component from being inserted in reverse.

[0034] The main unit housing 11 is made of medical-grade engineering plastic that is resistant to wiping and disinfection, and the periphery of the mounting slot 14 has a smooth, wipeable surface. Operation buttons 12 are used to start, cancel, or query test records; the patient information reading interface 13 is used to read patient wristband barcodes, near-field communication tags, or receive manually entered patient codes.

[0035] See Figure 2The disposable saliva collection component 2 is made of medical-grade polymer material. A saliva inlet 25 is formed at the upper end of the collection chamber 21. The diameter of the saliva inlet 25 is larger than the diameter of the quantitative detection chamber 26, allowing the patient to collect samples by drooling or spitting. The lower part of the collection chamber 21 gradually narrows to form a flow guiding structure 22. The inner wall of the flow guiding structure 22 is continuous and smooth, reducing sample residue.

[0036] The quantitative detection chamber 26 is a transparent or semi-transparent cylindrical cavity with a quantitative marking structure 23 on its side wall. The quantitative marking structure 23 includes a minimum effective liquid level mark and a preset maximum liquid level mark. The lower edge of the overflow inlet is flush with the preset maximum liquid level and is connected to the closed overflow chamber 27 through a short channel. The overflow chamber 27 can be equipped with absorbent material or a check valve to accommodate excess sample and reduce backflow.

[0037] The pH-sensitive element 31, reference electrode 34, and temperature compensation element 32 are fixed to the lower inner wall of the quantitative detection chamber 26, ensuring that their sensitive areas are covered by the sample after the sample reaches the minimum effective liquid level. The conductors of the sensing elements are encapsulated in the chamber wall and led to the component electrical contact 244. The calibration information carrier 245 is located inside or near the detection interface 24 and is connected to the component electrical contact 244 via the calibration information contact. The detection interface 24 forms a unique installation direction with the mounting groove 14 through the anti-rotation guide 241 and the limiting shoulder 242; the annular elastic seal 243 seals the gap between the detection interface 24 and the mounting groove 14.

[0038] Figure 2 A partial cross-section shows the mating relationship after the detection interface 24 is inserted into the mounting groove 14. After the D-shaped or flat anti-rotation guide 241 enters the corresponding guide structure 141, the outwardly expanding limiting shoulder 242 abuts against the stop surface in the mounting groove 14; the component electrical contact 244 and the host electrical contact 143 respectively form oppositely arranged contact groups and are pressed together for conduction; the installation position detection element 142 is separately disposed on the side wall of the mounting groove 14, and its position change is pushed or sensed by the detection interface 24. The elastic seal 243 is disposed around the outer periphery of the detection interface 24 and is spatially separated from the installation position detection element 142.

[0039] In this embodiment, the pH sensing element 31 is a solid-state electrochemical pH working electrode, and the reference electrode 34 is a solid-state reference electrode; both can be mounted on the same sensor substrate. The temperature compensation element 32 is a thermistor. The disposable detection unit is calibrated using a standard buffer solution at the factory to obtain zero-point parameters, slope parameters, and temperature compensation parameters, and the corresponding parameters and batch identifier are written into the calibration information carrier 245.

[0040] After the disposable saliva collection component 2 is installed, the detection host 1 reads the parameters in the calibration information carrier 245 via the host electrical contact 143 and the component electrical contact 244. The signal conversion unit 33 enters the detection sampling state only when the installation signal, contact conduction status, and calibration parameter reading status are all valid. The signal conversion unit 33 collects the potential difference between the pH sensing element 31 and the reference electrode 34, as well as the output signal of the temperature compensation element 32, and performs signal conversion with an internal calculation resolution of not less than 0.01 pH units; the display screen 51 displays the final result in 0.1 pH units.

[0041] The validity determination unit 45 performs a self-test on the detection host before sampling and confirms the detection signal range. The data processing module 4 converts the potential difference signal and performs temperature compensation according to the factory calibration parameters, and then judges the stability of the internal sampled values. For example, a stability condition can be defined as the difference between the maximum and minimum values ​​of the internal sampled values ​​not exceeding 0.05 pH units within 5 consecutive seconds; the above values ​​are only preferred parameters and can be adjusted according to the noise level of the selected sensing element and the product verification results. If the stability condition is not reached within the preset maximum detection time, the result is marked as invalid and a detection timeout prompt is displayed.

[0042] After the patient identification is read, the patient information association unit 44 establishes an association identifier for subsequent test records. The time stamp unit 42 writes the test date and test time for each record. Nursing staff can also enter treatment stage and sampling condition markers through the operation button 12 or the input interface; the sampling condition markers are used to indicate situations that may affect the test results, such as eating, drinking, brushing teeth, rinsing, or applying topical medications.

[0043] The trend analysis unit 43 determines the daily representative value according to a preset detection time window. If there is only one valid detection result within the time window, that result is used; if there are multiple valid detection results, the median is used. Results marked as invalid by the validity determination unit 45, or those marked as having significantly interfered with sampling conditions, are not included in the calculation of the representative value and the number of consecutive observation days.

[0044] The trend analysis unit 43 compares the daily representative value with the individual baseline value, the previous representative value, and the preset attention threshold, and generates a dynamic change status of stable, declining, below the attention threshold, or persistently abnormal. The attention threshold, the number of consecutive observation days, and the retest interval are configured by personnel with management authority according to the institution's nursing system and the applicable population, and are not used as the basis for the device's automatic diagnosis of diseases.

[0045] Display screen 51 shows the patient code, current valid test results, sample temperature, test time, representative value for the day, and historical change status. Status indicator unit 52 displays statuses such as component not installed, component installed correctly, test in progress, result stable, connection abnormality, calibration parameter reading abnormality, host self-test abnormality, over-range, or test timeout.

[0046] Nursing prompt unit 53 calls preset prompt templates based on dynamic changes in status. For example, when the status is stable, it outputs a prompt to monitor according to the original plan; when the result is lower than the preset attention threshold, it outputs a prompt to retest at a specified time and reassess the status of the artificial oral cavity; when the status is abnormal for several consecutive observation days, it outputs a prompt to increase the monitoring frequency and report to the responsible nurse or specialist nurse. The prompts are only process reminders and do not include disease diagnosis conclusions or specific medication orders.

[0047] After a single test is completed, the disposable saliva collection component 2, along with the pH sensing element 31, reference electrode 34, temperature compensation element 32, component electrical contacts 244, and calibration information carrier 245, is disassembled from the main unit 1 and disposed of as medical waste. The main unit 1 does not directly contact the saliva sample, and the exposed surfaces of its main unit housing 11 and mounting slot 14 can be wiped and disinfected according to the regulations of medical institutions.

[0048] The main testing unit 1 can perform self-tests or standard signal verifications on the signal conversion unit 33 based on the number of uses or a preset cycle. When the self-test or standard signal verification result exceeds the allowable deviation, the data processing module 4 pauses the generation of valid test results and outputs a maintenance prompt. The sensor calibration of the disposable testing unit is provided by the factory calibration and calibration information carrier 245, and repeated calibration of the disposable sensing element at the bedside is not required.

[0049] The above embodiments are merely preferred embodiments of the present invention. Equivalent substitutions or combinations made to the acquisition cavity, flow guiding structure, overflow structure, installation positioning structure, installation positioning detection method, reference electrode form, calibration information carrier form, data validity judgment conditions, and prompt templates can all be implemented within the scope of the present invention.

Claims

1. A device for dynamic monitoring of saliva pH and providing oral care reminders, characterized in that, The device includes a detection host (1) and a disposable saliva collection assembly (2) detachably connected to the detection host (1); the disposable saliva collection assembly (2) includes a saliva inlet (25), a collection chamber (21), a flow guiding structure (22) and a quantitative detection chamber (26) connected in sequence, an overflow chamber (27) connected to the quantitative detection chamber (26), a cover (28) for sealing the saliva inlet (25), an anti-backflow baffle (29) provided below the saliva inlet (25), a detection interface (24) provided at the lower part of the quantitative detection chamber (26), and a calibration information carrier (245); the lower edge of the overflow inlet of the overflow chamber (27) is flush with the preset maximum liquid level of the quantitative detection chamber (26); The pH-sensitive element (31), reference electrode (34), and temperature compensation element (32) are fixedly disposed in the quantitative detection chamber (26). The sensitive areas of the pH-sensitive element (31), reference electrode (34), and temperature compensation element (32) are located below the lowest effective liquid level and below the overflow inlet, and are respectively electrically connected to the component electrical contact (244) at the detection interface (24) through conductors embedded in the component wall. The detection interface (24) is provided with an anti-rotation guide (241), a limiting shoulder (242), and an elastic seal (243). The component electrical contact (244) The device includes sensor signal contacts and calibration information contacts. The calibration information carrier (245) is connected to the calibration information contacts and stores the factory calibration parameters and batch identifier of the disposable saliva collection component (2). The detection host (1) includes a detection host housing (11), a mounting slot (14) adapted to the detection interface (24), a signal conversion unit (33), a data processing module (4), a display prompt module (5), a power supply module (6), and a detection timing module (7). The mounting slot (14) is provided with a guide structure (141) adapted to the anti-rotation guide part (241). The installation detection element (142) and the host electrical contact (143) cooperating with the component electrical contact (244); when the disposable saliva collection component (2) is inserted along the guide structure (141) and the installation position is defined by the limiting shoulder (242), the component electrical contact (244) and the host electrical contact (143) are connected, the installation detection element (142) outputs an installation signal, and the data processing module (4) reads the factory calibration parameters through the host electrical contact (143); only when the installation signal, the electrical contact connection status, and the factory calibration parameters are read are the parameters present. When all states are valid, the signal conversion unit (33) enters the detection sampling state and the detection timing module (7) starts timing; the signal conversion unit (33) is used to acquire the potential difference signal between the pH sensitive element (31) and the reference electrode (34) and the temperature signal of the temperature compensation element (32); the data processing module (4) is used to convert and temperature compensate the potential difference signal according to the factory calibration parameters, and perform host self-test, detection result validity judgment and stability judgment, and store the detection results that meet the preset valid conditions with the patient identification and detection time. The display prompt module (5) is used to display the test results, the working status of the device, and the retest or manual re-evaluation prompt information generated based on multiple valid test results.

2. The apparatus according to claim 1, characterized in that, The flow guiding structure (22) is a funnel-shaped flow guiding channel that contracts from the bottom of the collection chamber (21) to the quantitative detection chamber (26). The overflow inlet is located on the side wall of the quantitative detection chamber (26), and the lower edge of the overflow inlet is flush with the preset maximum liquid level. The overflow chamber (27) is a closed side chamber, and a check structure is provided at the overflow inlet to prevent the overflow sample from flowing back into the quantitative detection chamber (26).

3. The apparatus according to claim 1, characterized in that, One end of the anti-backflow baffle (29) is rotatably or flexibly connected to the inner wall below the saliva inlet (25), and the other end can be opened in the saliva inlet direction and fit against the corresponding stop surface when the disposable saliva collection assembly (2) is tilted or moved; a sealing ring is provided between the top cover (28) and the saliva inlet (25).

4. The apparatus according to claim 1, characterized in that, The anti-rotation guide (241) has a D-shaped cross section, a circular cross section with a plane, or a non-circular cross section with a keyway. The limiting shoulder (242) is an outwardly expanding step set on the outer periphery of the detection interface (24). The elastic seal (243) is arranged around the outer periphery of the anti-rotation guide (241) and located between the limiting shoulder (242) and the component electrical contact (244). The guide structure (141) and the stop surface in the mounting groove (14) cooperate with the anti-rotation guide (241) and the limiting shoulder (242) respectively to limit the insertion direction, installation depth and circumferential position of the disposable saliva collection component (2).

5. The apparatus according to claim 1, characterized in that, The pH-sensitive element (31) is a solid-state electrochemical pH working electrode or an ion-sensitive field-effect transistor sensing element, and the reference electrode (34) is a solid-state reference electrode; the pH-sensitive element (31) and the reference electrode (34) adopt a discrete structure or are packaged in the same sensor substrate; the temperature compensation element (32) is a thermistor; the internal calculation resolution of the signal conversion unit (33) is not less than 0.01 pH units, and the pH display resolution of the display prompt module (5) is 0.1 pH units; When the difference between the maximum and minimum values ​​of multiple internal sampled values ​​within a preset stable time is not greater than a preset stable threshold, the data processing module (4) determines the corresponding detection result as a stable result.

6. The apparatus according to claim 1, characterized in that, The data processing module (4) includes a data storage unit (41), a time stamping unit (42), a trend analysis unit (43), a patient information association unit (44), and a validity determination unit (45). The validity determination unit (45) is used to generate valid or invalid markers based on the installation signal, the electrical contact conduction status, the factory calibration parameter reading status, the detection host self-test status, whether the detection signal is within the preset range, and the stability judgment result. Detection results with invalid markers do not participate in trend calculation.

7. The apparatus according to claim 6, characterized in that, The trend analysis unit (43) is used to select the effective detection results as the representative value of the day within the preset detection time window of each observation day; The result is used when there is only one valid detection result within the preset detection time window; when there are multiple valid detection results, the median result is used. The trend analysis unit (43) generates dynamic change states of stability, decline, below the attention threshold, or continuous abnormality based on representative values, individual baseline values, and preset attention thresholds for multiple consecutive observation days.

8. The apparatus according to claim 1, characterized in that, The detection host (1) also includes operation buttons (12) and a patient information reading interface (13). The patient information reading interface (13) is at least one of a barcode reader, a near-field communication reader, or a manual input interface. The display prompt module (5) includes a display screen (51), a status indicator unit (52), and a nursing prompt unit (53). The nursing prompt unit (53) calls a preset prompt template according to the dynamic change status and outputs prompts for continued monitoring, retesting at a specified time, re-evaluation of the artificial oral cavity status, or adjustment of monitoring frequency. It does not output disease diagnosis conclusions or medication orders.

9. The apparatus according to claim 1, characterized in that, The disposable saliva collection component (2), pH sensitive element (31), reference electrode (34), temperature compensation element (32), component electrical contact (244) and calibration information carrier (245) constitute a disposable detection unit, which is disassembled from the detection host (1) after a single detection is completed; the mounting slot (14) of the detection host (1) and the detection host housing (11) adopt a wipeable disinfection structure.

10. A method for processing saliva pH detection data and generating prompt information performed by the device of claim 1, characterized in that, include: S1. After the installation of the test piece is completed, the component electrical contacts are connected to the host electrical contacts, and the factory calibration parameters are successfully read, the control signal conversion unit enters the detection sampling state and receives the potential difference signal between the pH sensitive element and the reference electrode and the sample temperature signal output by the temperature compensation element. S2. Calculate and temperature-compensate the potential difference signal according to the factory calibration parameters, and determine the validity of the test result based on the installation status, electrical contact conduction status, factory calibration parameter reading status, test host self-test status, test range, and preset stability conditions; S3. Store the valid test results in association with the patient identification, test date, and test time, and exclude invalid test results from trend calculation after marking them. S4. Determine the representative value of the day within the preset detection time window of each observation day, and compare the representative value of the day with the individual baseline value, the previous representative value and the preset attention threshold to generate a dynamic change status; S5. Based on the dynamic change status, call the preset prompt template to generate a prompt code for retesting, manual review, or monitoring frequency adjustment; S6. Output the current valid test results, historical representative values, device working status, and prompt information corresponding to the prompt code through the display prompt module.