A gynecological ovulation test aid

Abstract

The present application relates to the field of medical devices, in particular to a gynecological ovulation test auxiliary device, comprising a detector and a test card; the detector is used for reading the color development of the detection end of the test card; further comprising a urine collection part for collecting urine samples, the urine collection part is provided with a first collection cavity and a second collection cavity from top to bottom, respectively, a infiltration groove is communicated between the first collection cavity and the second collection cavity, the top of the infiltration groove is communicated with the first collection cavity through a first opening, the bottom of the infiltration groove is communicated with the second collection cavity through a second opening, when the collection end of the test card is inserted into the infiltration groove, the collection end of the test card is in sliding fit with the infiltration groove; a timing switching mechanism is further arranged in the urine collection part, the timing switching mechanism is used for alternately realizing the on-off of the first opening and the second opening within a preset period. The present application can standardize the operation process and reduce the interference of human factors, thereby improving the accuracy of ovulation prediction.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to a gynecological ovulation testing auxiliary device. Background Technology

[0002] Ovulation monitoring is a crucial aspect of obstetrics and gynecology, playing a key role in preconception guidance, infertility diagnosis, and contraception. Currently, commonly used clinical methods for ovulation monitoring include basal body temperature measurement, cervical mucus observation, ovulation test strips (luteinizing hormone test strips), and ultrasound monitoring.

[0003] Among them, ovulation test strips have become the most commonly used self-testing method for women trying to conceive due to their ease of use, low cost, and quick result interpretation. Their principle is to predict ovulation time by detecting the peak level of luteinizing hormone (LH) in urine. However, in practical use, existing ovulation test strips and related tools have the following technical shortcomings:

[0004] Traditional ovulation test strips are mostly test strips or pens. Users need to hold the strip and immerse it in urine for a certain time before removing it and laying it flat. During this process, the depth of immersion, the immersion time, and the angle at which the strip is placed (whether flat or not) all depend on the user's manual control. Differences in testing habits among different users can easily lead to uneven urine flow on the reaction membrane, resulting in a "blotchy" appearance or inaccurate color development, directly affecting the reliability of the test results.

[0005] Most devices rely on users to capture the color results of the test strip using their smartphone cameras or simple readers. Due to significant differences in users' operating habits, shooting angles, and ambient lighting conditions, the color reproduction of the captured test strip images varies, which can easily lead to misjudgment of LH peak concentration, thus causing missed or misjudged ovulation window periods.

[0006] Given the shortcomings of existing technologies, there is an urgent need for a gynecological ovulation testing auxiliary device that can standardize the operation process, reduce human interference, and thus improve the accuracy of ovulation prediction. Summary of the Invention

[0007] To address the aforementioned problems, this invention provides a gynecological ovulation testing auxiliary device to improve the accuracy of ovulation prediction.

[0008] To achieve the above objectives, the technical solution of the present invention is as follows: A gynecological ovulation test auxiliary device includes a detector and a test card; the detector is used to read the color development of the detection end of the test card; it also includes a urine collection section for collecting urine samples, wherein a first collection chamber and a second collection chamber are respectively arranged from top to bottom in the urine collection section, and an immersion tank is connected between the first collection chamber and the second collection chamber. The top of the immersion tank is connected to the first collection chamber through a first opening, and the bottom of the immersion tank is connected to the second collection chamber through a second opening. When the collection end of the test card is inserted into the immersion tank, the collection end of the test card slides in the immersion tank; the urine collection section is also provided with a timed switching mechanism, which is used to alternately open and close the first opening and the second opening within a preset cycle.

[0009] The technical principles of the above solution are as follows:

[0010] The user inserts the sampling end of the test card horizontally into the immersion tank of the urine collection section. Since the immersion tank and the sampling end of the test card are in a sliding fit, the insertion depth and fit are consistent each time.

[0011] The urine sample to be tested is poured into the first collection chamber. At this time, since the initial state of the timed switching mechanism is the first opening closed, the urine sample is temporarily retained in the first collection chamber and will not automatically flow into the immersion tank.

[0012] Move the test card along with the urine collection unit as a whole, and insert the testing end of the test card into the detector to prepare for reading.

[0013] The timed switching mechanism is activated. The mechanism first opens the first opening while simultaneously closing the second opening. Urine in the first collection chamber flows quantitatively into the immersion tank under gravity, ensuring the collection end of the test strip is completely submerged in the urine for the chromatographic reaction. Because the space of the immersion tank is fixed, the contact area and time between the urine and the test strip are controlled by the device, avoiding color deviations caused by inconsistent depths or excessively long or short immersion times when manually holding the strip.

[0014] After a preset period (sufficient for urine to reach the reaction zone via chromatography), the timer switching mechanism automatically switches states: closing the first opening and opening the second opening. At this time, any excess residual urine in the immersion tank flows into the second collection chamber through the second opening. This action prevents antibody elution or background staining that might occur if the test card is immersed in urine for an extended period, ensuring the purity of the color development on the reaction membrane.

[0015] After completing the above steps, the device is left to stand and allow the reaction to proceed fully. Subsequently, the detector, under built-in fixed illumination and angle, collects standardized data on the color development at the test card's detection end, and calculates the LH concentration based on this data to predict the ovulation time.

[0016] The above approach has the following beneficial effects:

[0017] 1. This solution ensures consistency in the insertion depth and wetting area of ​​the test strip each time through the sliding cooperation between the wetting tank and the test card, thus solving the problem of inconsistent immersion depth when manually inserted.

[0018] The automatic control of urine-test strip contact time via a timed switching mechanism (first opening for wetting, then opening for waste removal) ensures sufficient chromatography time while avoiding detection failure or result deviation due to excessively long soaking time (antibody elution, watermark) or too short soaking time (insufficient color development).

[0019] The detector has a built-in fixed light source and acquisition angle, which eliminates image color distortion and interpretation errors caused by differences in ambient light and shooting angle when users take pictures themselves, ensuring the accuracy and repeatability of data acquisition.

[0020] 2. With this solution, users only need to complete three simple steps: emptying urine, inserting the detector, and starting the device. Subsequent soaking, waste removal, and timing are all completed automatically by the device. Users do not need to hold the test strip and keep an eye on the timer, which greatly simplifies the operation process.

[0021] No longer relying on users' visual color comparison or unprofessional photography, the instrument performs standardized reading and analysis, reducing subjective human judgment and making the results more objective and reliable.

[0022] 3. This solution, through the ingenious connection design of the upper and lower double-layer cavities (first collection cavity and second collection cavity) and the immersion tank, combined with the timed switching mechanism, realizes three major functions of urine temporary storage, quantitative supply and automatic waste discharge in a simple mechanical structure. The structure is compact and easy to implement.

[0023] Furthermore, the timing switching mechanism includes a rotating groove within the urine collection section, in which a cylinder is rotatably fitted. A notch is formed on the side wall of the cylinder, alternating between the notch and a first opening and a second opening. A timing cylinder is coaxially and fixedly connected to the cylinder, rotatably connected to the urine collection section. A sliding groove is also formed within the timing cylinder, coaxial with the rotating groove. A spring and a push button are disposed within the sliding groove, slidingly connected to the sliding groove. Both ends of the spring are fixedly connected to the push button and the inner wall of the sliding groove, respectively. A protrusion is fixedly connected to the outer side of the push button. A spiral groove is formed on the inner wall of the sliding groove, slidingly engaging the protrusion and the spiral groove. When the user presses the push button, the timing cylinder rotates half a turn, and the notch switches from the second opening to communicating with the first opening. When the user releases the push button, the spring resets the push button within a preset cycle, and the notch switches from the first opening to communicating with the second opening.

[0024] Beneficial effects: Utilizing the elastic potential energy of a spring as a power source, the timing cylinder is driven to rotate through the linear motion of the button. When the button is pressed, the protrusion slides within the spiral groove, causing the timing cylinder to rotate rapidly half a revolution, quickly switching the notch from the second opening to the first opening, thus achieving rapid urine supply.

[0025] After the button is released, the spring slowly pushes the button back to its original position within a preset cycle. The timing cylinder rotates half a turn in the opposite direction, causing the notch to switch from the first opening back to the second opening, thus achieving automatic waste discharge.

[0026] By precisely designing the spring constant and the lead of the spiral groove, the time required for component reset (i.e., the preset cycle) can be set, thereby accurately controlling the soaking time of the test strip (e.g., within a standard time of 15-20 seconds). This purely mechanical timing method eliminates the need for electronic components, avoiding the requirement for battery power and ensuring reliability in complex environments.

[0027] Furthermore, the detector has a built-in timer switch, a light sensor, a light source, a processor, and an interactive unit. The timer switch is used to activate the light sensor and the light source after a preset reaction cycle. The light sensor is used to receive emitted or projected light from the detection end on the test card. The light source is used to provide light. The processor is used to analyze and determine the LH concentration based on the information collected by the light sensor. The interactive unit is used to display the analysis results from the processor.

[0028] Beneficial effects: The timer switch ensures that the light sensor and light source will not start prematurely before the color reaction of the test strip is complete, nor will they be indefinitely delayed if the user forgets. It automatically triggers the reading strictly after the preset reaction period (e.g., 5-10 minutes, i.e., the time when the test strip color tends to stabilize), ensuring that the timing of each reading fully conforms to the chemical reaction kinetics requirements of the reagent, avoiding misjudgments caused by improper reading time (too early leading to insufficient color development, too late leading to background oxidation).

[0029] Furthermore, it also includes a wristband, a continuous body temperature detection module, an LH quantitative detection module, and an early warning module. The wristband is equipped with a temperature sensor for collecting the user's basal body temperature. The continuous body temperature detection module collects the user's basal body temperature at a preset frequency and generates a continuous body temperature curve. The LH quantitative detection module automatically collects LH concentration daily and generates LH concentration time-series data. The processor is also used to filter and extract trends from the continuous body temperature curve to obtain body temperature characteristic parameters, and to model the LH concentration time-series data using mathematical methods to predict the probability of LH peak occurrence within a preset time period. The body temperature characteristic parameters, LH concentration time-series data, and prediction results are input into a pre-trained multi-parameter fusion model to output a dynamically updated conception probability curve. The early warning module is used to issue an early warning message to the user when the conception probability curve indicates that the probability of conception exceeds a preset threshold.

[0030] Beneficial effects: Traditional ovulation monitoring relies solely on the LH surge, but the LH surge lasts only a short time and is easily missed. While basal body temperature reflects the post-ovulation rise in progesterone, it has a lag effect (ovulation often occurs before the temperature rises). This invention achieves continuous basal body temperature monitoring via a wristband, combined with daily LH quantitative detection, enabling simultaneous collection of dual physiological indicators of hormones and body temperature, comprehensively assessing ovulation status from both endocrine and energy metabolism dimensions.

[0031] When the LH surge occurs but body temperature does not rise, ovulation can be considered imminent; when body temperature rises continuously, ovulation can be retrospectively confirmed. This cross-verification of data effectively reduces the risk of false positives or false negatives that may arise from relying on a single indicator.

[0032] Furthermore, mathematical methods include Kalman filtering or Gaussian process regression.

[0033] Beneficial effects: Kalman filtering employs a recursive prediction-update mechanism, enabling real-time processing of newly entered LH concentration data daily. It not only filters out random errors that may exist in a single test (such as batch differences in test strips, minor operational deviations, etc.), but also dynamically estimates the current cycle stage (such as the follicular phase, peak rise phase) based on the statistical patterns of historical data.

[0034] Gaussian process regression is a non-parametric model that does not presuppose the specific shape of the LH curve (such as whether it is symmetrical or how kurtosis is). It can adaptively learn the personalized waveform characteristics of the LH curve based on each user's unique historical periodic data (for example, some people have steep peaks, while others have gentle peaks).

[0035] Using LH features (such as rising slope, estimated peak time, and predicted curve) processed by Kalman filtering or Gaussian process regression as input to subsequent multi-parameter fusion models (such as neural networks) can significantly improve the training efficiency and prediction accuracy of the fusion model.

[0036] Furthermore, the multi-parameter fusion model is a Long Short-Term Memory (LSTM) network.

[0037] Beneficial effects: A woman's menstrual cycle typically lasts 21-35 days, and there is a fixed temporal relationship between the LH peak and basal body temperature changes (LH peak first, followed by temperature rise). Long Short-Term Memory (LSTM) networks, through the coordinated operation of their forgetting gate, input gate, and output gate, can effectively learn and remember key events throughout the cycle, preventing early information from being forgotten during long-term transmission. There are significant differences in cycle length, LH peak duration, and temperature rise among different women. LSTM networks can automatically learn and extract individualized cycle pattern features from a user's historical data over several consecutive months, thereby providing more accurate predictions for the current cycle.

[0038] Furthermore, the wristband also integrates an accelerometer to detect the user's activity level; the processor is also used to correct the basal body temperature data based on the accelerometer data to eliminate body temperature fluctuations caused by exercise.

[0039] Beneficial Effects: Basal body temperature (BBT) requires measurement after sufficient sleep and before any physical activity. Its physiological significance lies in reflecting the metabolic level at rest. However, users may engage in limb movements such as turning over or getting up during sleep, and the measurement data may be contaminated in the morning due to the rush to get out of bed. An accelerometer monitors wrist movement in real time, and the processor identifies and eliminates or corrects abnormal temperature fluctuations caused by movement, ensuring that the BBT data used for analysis truly represents the resting state. By analyzing acceleration data, the processor can automatically determine the user's sleep and wake-up times and select periods of continuous inactivity at night as effective windows for temperature sampling, further ensuring the reliability of the data source.

[0040] Furthermore, it also includes a collaborative prediction module; the collaborative prediction module is used to normalize the time-aligned body temperature feature parameters and LH concentration time series data, and connect them in time order in a two-dimensional coordinate system with body temperature feature parameters and LH concentration time series data as the vertical axis and horizontal axis, respectively, to form a periodic closed trajectory.

[0041] The area enclosed by the periodic closed trajectory is extracted as a quantitative indicator to characterize the coupling strength between the current period's LH drive and body temperature response.

[0042] Quantitative indicators can be input into a multi-parameter fusion model, or compared with a preset reference threshold, to evaluate the validity of periodic data or identify abnormal period types.

[0043] Beneficial effects: In a normal, complete ovulation cycle, the LH drive (horizontal axis) and the temperature response (vertical axis) go through the process of "follicular phase (low LH, low temperature) - peak phase (sudden rise in LH, slight rise in temperature) - luteal phase (LH decline, high temperature)," ultimately forming an almost closed loop on a two-dimensional plane. The appearance of this "closed loop" intuitively indicates that the negative feedback regulation mechanism of the hypothalamus-pituitary-ovarian axis is functioning normally, and the pulsatile release of LH successfully drives ovulation and corpus luteum formation, thereby maintaining the high temperature phase.

[0044] The area enclosed by the periodic closed trajectory is extracted and defined as the "LH-driven-thermal response coupling strength". This single quantitative indicator can comprehensively reflect the degree of coordination between hormone fluctuations and body temperature response throughout the cycle. The larger the area, the higher the LH peak, the longer its duration, and the more timely the body temperature response and the better the maintenance of the high-temperature phase, that is, the more sound the endocrine regulation function.

[0045] This quantitative indicator can be used for longitudinal comparisons between different cycles of a user (such as assessing the effects of lifestyle improvements or drug treatments), and can also be used for horizontal comparisons with population reference thresholds to objectively evaluate the quality of the current cycle.

[0046] Some ovulation disorders (such as luteinized unruptured follicle syndrome) may present with a normal or even elevated LH surge, but the follicle fails to rupture, leading to a delayed temperature response or instability during the high-temperature phase. In such cases, the two-dimensional trajectory may not form a closed loop, or the trajectory area may be significantly smaller. By inputting this quantitative indicator into a multi-parameter fusion model (such as LSTM), the model can identify this abnormal pattern of "hormone-temperature" decoupling earlier and more accurately.

[0047] Different abnormal cycles will exhibit different morphological characteristics on a two-dimensional trajectory:

[0048] Anovulatory cycles: The trajectory may remain in the lower left corner of the low LH and low body temperature area, unable to extend to the right or upward, and the trajectory area is close to zero.

[0049] Luteal insufficiency: The trajectory may reach its peak to the right, but it quickly falls back after entering the high-temperature zone (shortened luteal phase), resulting in the trajectory not being able to close completely and having a smaller area.

[0050] High LH but no ovulation: The trajectory may extend far to the right (high LH), but not far upward (no temperature rise), the trajectory is flat, and the area is mainly contributed by the horizontal width.

[0051] By extracting the trajectory area and combining it with trajectory morphology analysis, the system can provide users with more refined abnormal cycle classification prompts.

[0052] Inputting the trajectory area as a higher-order feature into the existing LSTM and other multi-parameter fusion models is equivalent to providing the model with a layer of summary information. This helps the model to grasp the overall macroscopic coordination state of the entire cycle even when faced with local data noise or missing data, thus improving the robustness of predictions.

[0053] Inputting the trajectory area as a higher-order feature into the existing LSTM and other multi-parameter fusion models is equivalent to providing the model with a layer of summary information. This helps the model to grasp the overall macroscopic coordination state of the entire cycle even when faced with local data noise or missing data, thus improving the robustness of predictions.

[0054] The collaborative prediction module constructs a two-dimensional state-space trajectory of body temperature and LH (lower circadian rhythm), transforming abstract multi-parameter time-series data into intuitive geometric graphs and quantitative indicators. This not only provides doctors and users with a novel perspective on cyclical health assessment but also extracts higher-order features to feed back into the multi-parameter fusion model, further improving the system's accuracy in predicting ovulation status and its sensitivity in identifying abnormal cycles.

[0055] Furthermore, the collaborative prediction module also extracts the geometric features of the closed trajectory, including the perimeter, eccentricity, and center point position, and inputs the geometric features into the multi-parameter fusion model.

[0056] Beneficial effects: Area describes the overall scale of the cycle, while perimeter, eccentricity, and center point describe the stability, morphological tendency, and reference position of the cycle, respectively. These features characterize the intrinsic properties of the cycle from different perspectives and are complementary to each other. Using them as input features for a multi-parameter fusion model provides the model with richer and more comprehensive information dimensions, helping the model to more fully understand the uniqueness of each cycle.

[0057] Furthermore, the collaborative prediction module is also used to determine whether there is a tendency for luteal insufficiency, luteinized unruptured follicle syndrome, or polycystic ovary syndrome in the current cycle based on the degree of deviation between the area of ​​the closed trajectory and the average area of ​​historical cycles. When the deviation exceeds the threshold, the warning module will alert the user that there may be an abnormal endocrine state.

[0058] Beneficial effects: Every woman's menstrual cycle is unique, with significant individual differences in cycle length, LH peak level, and body temperature rise. By calculating the average area of ​​the trajectory across multiple normal cycles in a user's history, the system establishes a personalized "healthy cycle reference baseline" for that user. This personalized baseline reflects the user's normal physiological state more accurately than a general population threshold.

[0059] The current cycle's trajectory area is compared to the historical average area to calculate the deviation (e.g., percentage or standard deviation multiple). When the deviation exceeds a preset threshold, it indicates a significant abnormality in the hormone-temperature coordination of the current cycle, triggering an early warning. This allows users to receive early warnings of potential endocrine abnormalities without waiting for obvious clinical symptoms (such as long-term infertility or irregular menstruation). Attached Figure Description

[0060] Figure 1 This is a three-dimensional structural schematic diagram of an embodiment of the gynecological ovulation testing auxiliary device of the present invention;

[0061] Figure 2 This is a schematic diagram of the internal structure of the detector in the gynecological ovulation testing auxiliary device of the present invention;

[0062] Figure 3 This is a schematic diagram of the internal structure of the urine collection section in the gynecological ovulation testing auxiliary device of the present invention;

[0063] Figure 4 for Figure 3 A magnified view of a portion of point M in the middle.

[0064] The reference numerals in the accompanying drawings include: 1. Wristband; 2. Detector; 3. Carrier; 4. Urine collection section; 201. Detection groove; 301. Detection end; 302. Collection end; 401. First collection chamber; 402. Second collection chamber; 403. First opening; 404. Second opening; 405. Immersion tank; 406. Cylinder; 407. Notch; 408. Timing cylinder; 409. Button; 410. Slide groove; 411. Spring; 412. Spiral groove; 413. Protrusion; 414. Rotation groove. Detailed Implementation

[0065] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0066] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0067] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0068] The following detailed description illustrates the specific implementation method:

[0069] Example 1:

[0070] As attached Figure 1 -Appendix Figure 4 As shown: A gynecological ovulation testing auxiliary device includes a detector 2 and a test card; the detector 2 is used to read the color development of the detection end 301 of the test card; specifically, a detection slot 201 is horizontally opened inside the detector 2, and the test card includes a carrier 3, with a detection end 301 and a collection end 302 respectively embedded at both ends of the carrier 3, a detection window is opened on the detection end 301, and a detection window is opened on the collection end 302.

[0071] Combined with appendix Figure 3 As shown, the system also includes a urine collection unit 4 for collecting urine samples. The urine collection unit 4 has a first collection chamber 401 and a second collection chamber 402 arranged from top to bottom. Preferably, the top of the first collection chamber 401 is provided with a cover (not shown in the figure), which is detachably connected to the urine collection unit 4 via threads. An immersion tank 405 connects the first collection chamber 401 and the second collection chamber 402. The top of the immersion tank 405 connects to the first collection chamber 401 through a first opening 403, and the bottom of the immersion tank 405 connects to the second collection chamber 402 through a second opening 404. When the collection end 302 of the test card is inserted into the immersion tank 405, the collection end 302 of the test card slides into the immersion tank 405. The urine collection unit 4 also includes a timed switching mechanism, which alternately switches the first opening 403 and the second opening 404 within a preset period. Preferably, both the detection tank 201 and the immersion tank 405 are connected to slots. When the acquisition end 302 and the detection end 301 of the test card are inserted into the immersion tank 405 and the detection tank 201 respectively, both ends of the carrier 3 are engaged with the slots.

[0072] Specifically, the timing switching mechanism includes a rotating groove 414 located within the urine collection section 4. A cylinder 406 is rotatably fitted within the rotating groove 414. A notch 407 is provided on the side wall of the cylinder 406, which alternately communicates with a first opening 403 and a second opening 404. Initially, the notch 407 is aligned and connected with the second opening 404. A timing cylinder 408 is coaxially integrated with the cylinder 406 and rotatably connected to the urine collection section 4. Figure 4As shown, a sliding groove 410 is also provided inside the timer cylinder 408. The rotating groove 414 is coaxial with the sliding groove 410. A spring 411 and a pusher 409 are provided inside the sliding groove 410. The pusher 409 is slidably connected to the sliding groove 410. The two ends of the spring 411 are respectively bonded and fixed to the pusher 409 and the inner wall of the sliding groove 410. A protrusion 413 is welded and fixed to the outside of the pusher 409. A spiral groove 412 is provided on the inner wall of the sliding groove 410. The protrusion 413 and the spiral groove 412 are slidably engaged. When the user presses the pusher 409, the timer cylinder 408 rotates half a turn, and the notch 407 switches from the second opening 404 to communicate with the first opening 403. When the user releases the pusher 409, the spring 411 resets the pusher 409 within a preset period, and the notch 407 switches from the first opening 403 to communicate with the second opening 404. Preferably, in this embodiment, the button 409 consists of two parts. The part of the button 409 near the slide groove 410 is a cylindrical structure, and the other part of the button 409 is a rectangular block structure. The cylindrical part of the button 409 slides in conjunction with the slide groove 410. The protrusion 413 is arranged on the cylindrical part of the button 409. The rectangular block part of the button 409 is connected to the urine collection 4 (which has a groove to accommodate the sliding of the button 409. The groove is slidably connected to the rectangular block part of the button 409, and the inner wall of the groove constrains the button 409 so that the button 409 cannot rotate and can only slide).

[0073] Preferably, the detector 2 has a built-in timer switch, a light sensor, a light source, a processor, and an interaction unit. The timer switch is used to activate the light sensor and the light source after a preset reaction cycle. When the user releases the button 409 and presses the timer switch, the timer switch will power on the light sensor and the light source after the preset reaction cycle. The light sensor is used to receive the emitted or projected light from the detection end 301 on the test card and convert the light signal into an electrical signal. The light source is used to provide light, and both the light source and the light sensor are installed on the inner wall of the detection slot 201. The processor is used to analyze and determine the LH concentration based on the information collected by the light sensor. The color development degree of the detection end 301 of the test card is positively correlated with the LH concentration. The interaction unit is used to display the analysis results of the processor. The interaction unit (not shown in the figure) is a display screen, which is installed on the outside of the detector 2.

[0074] The specific implementation process is as follows:

[0075] First, the user removes the dried test card from the packaging. Holding the test card, the user aligns the collection end 302 horizontally with the slot on the side of the urine collection section 4 and pushes it inward along the slot until the collection end 302 is fully inserted into the immersion tank 405. Because the immersion tank 405 and the test card collection end 302 have a precise sliding fit design, the collection end 302 is precisely fixed in the immersion tank 405, ensuring consistent insertion depth each time. Simultaneously, the carrier 3 engages with the slot, providing temporary fixation and sealing.

[0076] Open the lid, pour the freshly collected urine sample into the first collection chamber 401 of the urine collection section 4, and close the lid.

[0077] In the initial state, the notch 407 on the side wall of the cylinder 406 of the timed switching mechanism is aligned and connected with the second opening 404, while the first opening 403 is closed by the wall of the cylinder 406. Therefore, the urine poured into the first collection chamber 401 is temporarily blocked and cannot flow into the immersion tank 405. It can only be temporarily stored in the first collection chamber 401, waiting for the next operation.

[0078] The user aligns the test end 301 of the test card with the slot on the tester 2 and pushes the test end 301 into the test slot 201 to complete the test preparation.

[0079] Subsequently, the user presses the button 409 with their finger. The button 409 slides inward within the groove 410 against the elastic force of the spring 411, causing the protrusion 413 on the outer side of the button 409 to slide within the spiral groove 412 on the inner wall of the timing cylinder 408. Due to the guiding effect of the spiral groove 412, the linear movement of the protrusion 413 forces the timing cylinder 408 (and the cylinder 406 coaxially fixed therewith) to rotate. When the button 409 is fully pressed down, the timing cylinder 408 has rotated exactly half a revolution (180 degrees). At this time, the notch 407 on the side wall of the cylinder 406 rotates from a position communicating with the second opening 404 to a position communicating with the first opening 403. The first opening 403 is opened, and the second opening 404 is closed by the wall of the cylinder 406. Under the action of gravity, the urine in the first collection chamber 401 flows quantitatively into the immersion tank 405 through the first opening 403, completely immersing the collection end 302 of the test card in the urine sample, and the chromatography reaction officially begins.

[0080] After the user releases the button 409, the button 409 is no longer pressed by external force. The spring 411, which was compressed in the groove 410, begins to release its elastic potential energy, pushing the button 409 to slowly reset. During the reset process of the button 409, the protrusion 413 slides again in the spiral groove 412, driving the timing cylinder 408 and the cylinder 406 to rotate in opposite directions. The elastic coefficient of the spring 411 and the lead of the spiral groove 412 are precisely designed so that the time required for the button 409 to reset to its initial position is exactly equal to the preset immersion period (e.g., 15-20 seconds, which meets the immersion time required by the test strip instructions). When the button 409 is fully reset, the timing cylinder 408 rotates half a turn again, and the notch 407 also rotates from the first opening 403 back to the second opening 404. At this time, the first opening 403 is closed, stopping the supply of urine; the second opening 404 is opened, and excess residual urine in the immersion tank 405 flows into the second collection chamber 402 below through the second opening 404. At this point, the contact between the test card and urine is automatically and precisely terminated, avoiding antibody elution or background staining caused by excessive soaking.

[0081] After the impregnation and waste removal steps are completed, the device enters the static color development stage (usually 5-10 minutes, i.e., the preset reaction cycle).

[0082] The user presses the timer switch on the detector 2 at the same time or shortly after releasing button 409. The timer switch starts timing, and after a preset reaction cycle, it automatically powers on the built-in light source and light sensor.

[0083] The light source provides a stable, repeatable standard illumination beam that shines onto the test window of the test card.

[0084] The light sensor receives reflected (or transmitted) light from the detection window and accurately converts the light signal reflecting the color depth into an electrical signal.

[0085] The processor receives electrical signals and analyzes and determines the concentration of LH in urine based on a preset algorithm (such as a color-concentration conversion model).

[0086] The interactive unit (display screen) intuitively displays the LH concentration values ​​and interpretation results (such as "negative", "peak", "ovulation is imminent") obtained by the processor to the user.

[0087] Example 2:

[0088] The difference from Embodiment 1 is that it also includes a wristband 1, a continuous body temperature detection module, an LH quantitative detection module, and an early warning module; the wristband 1 is equipped with a temperature sensor for collecting the user's basal body temperature; preferably, the wristband 1 is made of a flexible, skin-friendly material to ensure close contact with the skin during sleep at night. The wristband 1 also integrates an accelerometer for detecting the user's activity level; the processor is also used to correct the basal body temperature data based on the accelerometer data to eliminate temperature fluctuations caused by exercise.

[0089] The continuous body temperature monitoring module collects the user's basal body temperature at a preset frequency (e.g., once every 30 minutes) and generates a continuous body temperature curve; the LH quantification module automatically collects LH concentration daily and generates LH concentration time-series data; the processor also filters and extracts trends from the continuous body temperature curve to obtain body temperature feature parameters, models the LH concentration time-series data using Kalman filtering or Gaussian process regression, predicts the probability of LH peak occurrence within a preset time period, inputs the body temperature feature parameters, LH concentration time-series data, and prediction results into a pre-trained Long Short-Term Memory (LSTM) network, and outputs a dynamically updated conception probability curve; the early warning module issues an early warning message to the user when the conception probability curve indicates that the probability of conception exceeds a preset threshold.

[0090] Preferably, it also includes a collaborative prediction module; the collaborative prediction module is used to normalize the time-aligned body temperature feature parameters and LH concentration time series data, and connect them in time order in a two-dimensional coordinate system with body temperature feature parameters and LH concentration time series data as the vertical axis and horizontal axis, respectively, to form a periodic closed trajectory.

[0091] The area enclosed by the periodic closed trajectory is extracted as a quantitative indicator to characterize the coupling strength between the current periodic LH drive and body temperature response; preferably, the geometric features of the closed trajectory are also extracted, including the perimeter, eccentricity and center point position, and the geometric features are input into the multi-parameter fusion model.

[0092] Quantitative indicators can be input into a multi-parameter fusion model, or compared with a preset reference threshold, to evaluate the validity of periodic data or identify abnormal period types.

[0093] The collaborative prediction module is also used to determine whether there is a tendency for luteal insufficiency, luteinized unruptured follicle syndrome, or polycystic ovary syndrome in the current cycle based on the degree of deviation between the area of ​​the closed trajectory and the average area of ​​the historical cycle. When the deviation exceeds the threshold, the warning module will alert the user that there may be an abnormal endocrine state.

[0094] The specific implementation process is as follows:

[0095] During daily use, the user wears the wristband 1, which integrates temperature and acceleration sensors, on their wrist. Upon first use, the wristband 1 is paired with the processor (or accompanying mobile application) of the detector 2 via Bluetooth or NFC. The system automatically initializes the user profile and begins continuous monitoring mode.

[0096] During nighttime sleep, the continuous body temperature monitoring module automatically collects the user's wrist skin temperature at a preset frequency (e.g., once every 30 minutes) to generate a raw body temperature time series. The entire process requires no active user operation and does not affect sleep.

[0097] An accelerometer, working in sync with the temperature sensor, continuously records the user's wrist movements. The processor reads the acceleration data in real time, identifying periods of limb activity such as turning over or getting up at night. Based on a pre-set algorithm, the processor labels, removes, or weights the body temperature data corresponding to these periods, ultimately generating a pure, continuous basal body temperature curve that reflects the true resting metabolic state.

[0098] Users perform LH concentration testing daily using the gynecological ovulation testing aid device (or its matching detector 2) described in Example 1. The detector 2 automatically reads the color development results from the test card and wirelessly transmits the LH concentration value (e.g., mIU / mL) to the processor. Daily test results are stored by date, forming LH concentration time-series data.

[0099] The processor aggregates the daily updated data and performs the following intelligent analyses:

[0100] Body temperature feature extraction: The corrected continuous body temperature curve is filtered to extract key body temperature feature parameters, including: nighttime average body temperature, body temperature variability, onset point of high temperature period, and number of days of high temperature period.

[0101] LH prospective prediction: Kalman filtering or Gaussian process regression is used to model LH ​​concentration time series data.

[0102] When using Kalman filtering, the system recursively estimates the true state and trend of LH concentration in real time. Even before the peak arrives, it can predict the imminent peak based on the rising slope.

[0103] When using Gaussian process regression, the system fits a personalized periodic curve of LH concentration and outputs the predicted value of LH concentration and its confidence interval for the next few days.

[0104] Conception Probability Curve Generation: The aforementioned body temperature characteristic parameters, raw LH time-series data, and LH prediction results are time-aligned and normalized, and used as input feature vectors. These are then fed into a pre-trained Long Short-Term Memory (LSTM) network. The LSTM uses its memory units to learn the user-specific cycle patterns (such as cycle length, fixed intervals between LH peaks and body temperature rises), outputting a dynamically updated future conception probability curve. This curve, displayed on a daily basis, visually represents the likelihood of conception on each future day.

[0105] After a complete menstrual cycle ends (or when the cycle has progressed to a sufficient number of days), the collaborative prediction module initiates in-depth analysis:

[0106] Constructing a two-dimensional state-space trajectory: The time-aligned body temperature characteristic parameters and LH concentration time-series data are normalized (e.g., scaled to the [0,1] interval). With LH concentration as the horizontal axis (X-axis) and body temperature characteristic parameters as the vertical axis (Y-axis), the physiological state of each day is depicted as a point on a two-dimensional plane. Connecting these points in chronological order forms a two-dimensional closed trajectory representing the physiological evolution of that cycle.

[0107] Calculate the area enclosed by the closed trajectory. This area value quantitatively characterizes the coupling strength between LH drive and body temperature response during this cycle.

[0108] Further extraction of the trajectory's perimeter, eccentricity (reflecting whether the trajectory is nearly circular or flat), and center point location (reflecting the average LH and body temperature level during the cycle) was performed.

[0109] The current period's trajectory area is compared with the average area of ​​multiple normal periods in the user's history, and the deviation (such as the percentage of area shrinkage or increase) is calculated.

[0110] Combining area deviation direction, geometric features, and prior clinical knowledge, the system automatically makes a propensity judgment:

[0111] For example:

[0112] Significantly reduced area: suggests luteal insufficiency or a tendency toward luteinized unruptured follicle syndrome;

[0113] Significantly increased area and rightward shift of the center point: suggests a tendency towards polycystic ovary syndrome.

[0114] The discrimination results, along with the trajectory area and geometric features, are input into the LSTM model as high-order features to enhance the model's ability to identify abnormal patterns.

[0115] The early warning module monitors the conception probability curve and the output of the collaborative prediction module in real time. An early warning message will be sent to the user (via wristband vibration, mobile app push notifications, etc.) when any of the following conditions are met:

[0116] If the probability of conception exceeds a preset threshold (e.g., >20%), it indicates that you have entered the fertile window.

[0117] The collaborative prediction module detected that the area deviation of the periodic trajectory was too large, indicating that there may be an abnormal endocrine state. It is recommended that users pay attention or seek medical advice.

[0118] Interactive units (such as displays or mobile app interfaces) visually present users with daily basal body temperature curves, LH concentration values, conception probability curves, and two-dimensional state space trajectory diagrams, and provide cycle interpretation and health advice.

[0119] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A gynecological ovulation testing auxiliary device, comprising a detector (2) and a test card; the detector (2) is used to read the color development of the detection end (301) of the test card; characterized in that, It also includes a urine collection unit (4) for collecting urine samples. The urine collection unit (4) is provided with a first collection chamber (401) and a second collection chamber (402) from top to bottom. An immersion tank (405) is connected between the first collection chamber (401) and the second collection chamber (402). The top of the immersion tank (405) is connected to the first collection chamber (401) through a first opening (403), and the bottom of the immersion tank (405) is connected to the second collection chamber (402) through a second opening (404). When the collection end (302) of the test card is inserted into the immersion tank (405), the collection end (302) of the test card slides into the immersion tank (405). The urine collection unit (4) is also provided with a timed switching mechanism, which is used to alternately open and close the first opening (403) and the second opening (404) within a preset period.

2. The gynecological ovulation testing auxiliary device according to claim 1, characterized in that, The timing switching mechanism includes a rotating groove (414) located within the urine collection section (4). A cylinder (406) is rotatably fitted within the rotating groove (414). A notch (407) is provided on the side wall of the cylinder (406), and the notch (407) alternately communicates with the first opening (403) and the second opening (404). A timing cylinder (408) is coaxially fixedly connected to the cylinder (406). The timing cylinder (408) is rotatably connected to the urine collection section (4). A sliding groove (410) is also provided within the timing cylinder (408). The sliding groove (410) is coaxial with the rotating groove (414). A spring (411) and a pusher (409) are provided within the sliding groove (410). The pusher (409) slides against the sliding groove (410). The spring (411) is fixedly connected to the inner wall of the button (409) and the slide (410) at both ends. The button (409) is fixedly connected to the outer side of the button (409). The slide (410) has a spiral groove (412) on the inner wall. The protrusion (413) and the spiral groove (412) slide together. When the user presses the button (409), the timer cylinder (408) rotates half a turn, and the notch (407) switches from the second opening (404) to communicate with the first opening (403). When the user releases the button (409), the spring (411) resets the button (409) within a preset period, and the notch (407) switches from the first opening (403) to communicate with the second opening (404).

3. The gynecological ovulation testing auxiliary device according to claim 2, characterized in that, The detector (2) has a built-in timer switch, a light sensor, a light source, a processor, and an interactive unit. The timer switch is used to activate the light sensor and the light source after a preset reaction cycle. The light sensor is used to receive the emitted light or projected light from the detection end (301) on the test card. The light source is used to provide light. The processor is used to analyze and determine the LH concentration based on the information collected by the light sensor. The interactive unit is used to display the analysis results of the processor.

4. The gynecological ovulation testing auxiliary device according to claim 3, characterized in that, It also includes a wristband (1), a continuous body temperature detection module, an LH quantitative detection module and an early warning module; the wristband (1) is equipped with a temperature sensor for collecting the user's basal body temperature; The continuous body temperature detection module is used to collect the user's basal body temperature at a preset frequency and generate a continuous body temperature curve; The LH quantitative detection module automatically collects LH concentration data daily, generating time-series LH concentration data. The processor also filters and extracts trends from the continuous body temperature curve to obtain body temperature characteristic parameters. It uses mathematical methods to model the LH concentration time-series data, predicting the probability of LH peak occurrence within a preset time period. The body temperature characteristic parameters, LH concentration time-series data, and prediction results are input into a pre-trained multi-parameter fusion model, outputting a dynamically updated conception probability curve. The early warning module issues a warning to the user when the conception probability curve indicates that the probability of conception exceeds a preset threshold.

5. The gynecological ovulation testing auxiliary device according to claim 4, characterized in that, Mathematical methods include Kalman filtering or Gaussian process regression.

6. The gynecological ovulation testing auxiliary device according to claim 5, characterized in that, The multi-parameter fusion model is a Long Short-Term Memory (LSTM) network.

7. The gynecological ovulation testing auxiliary device according to claim 6, characterized in that, The wristband (1) also integrates an accelerometer to detect the user's activity status; the processor is also used to correct the basal body temperature data based on the accelerometer data to eliminate body temperature fluctuations caused by exercise.

8. The gynecological ovulation testing auxiliary device according to claim 7, characterized in that, It also includes a collaborative prediction module; the collaborative prediction module is used to normalize the time-aligned body temperature feature parameters and LH concentration time series data, and connect them in time order in a two-dimensional coordinate system with body temperature feature parameters and LH concentration time series data as the vertical axis and horizontal axis, respectively, to form a periodic closed trajectory. The area enclosed by the periodic closed trajectory is extracted as a quantitative indicator to characterize the coupling strength between the current period's LH drive and body temperature response. Quantitative indicators can be input into a multi-parameter fusion model, or compared with a preset reference threshold, to evaluate the validity of periodic data or identify abnormal period types.

9. The gynecological ovulation testing auxiliary device according to claim 8, characterized in that, The collaborative prediction module also extracts the geometric features of the closed trajectory, including the perimeter, eccentricity, and center point position, and inputs the geometric features into the multi-parameter fusion model.

10. The gynecological ovulation testing auxiliary device according to claim 9, characterized in that, The collaborative prediction module is also used to determine whether there is a tendency for luteal insufficiency, luteinized unruptured follicle syndrome, or polycystic ovary syndrome in the current cycle based on the degree of deviation between the area of ​​the closed trajectory and the average area of ​​the historical cycle. When the deviation exceeds the threshold, the warning module will alert the user that there may be an abnormal endocrine state.

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