Multifunctional visual uterine cavity operation system and control method thereof

Abstract

This invention discloses a multifunctional visual uterine cavity operating system and its control method, relating to the field of gynecological uterine cavity diagnostic and therapeutic instruments. The system includes a catheter body with a layered cavity, a camera module, a flexible expansion component, an infusion control unit, an image acquisition module, and an image processing module. By filling the flexible expansion component with expansion medium, an observation cavity is formed at the catheter tip. The image processing module calculates image quality metrics and site suitability based on real-time images, and outputs an infusion adjustment signal to the infusion control unit according to the image quality metrics, dynamically adjusting the infusion pressure to form a closed-loop control between the infusion pressure and the image quality metrics, thereby stabilizing the imaging effect. Simultaneously, the system adaptively adjusts the decision threshold and the required number of frames based on image quality, and outputs visual guidance information in conjunction with temporal smoothing and hysteresis judgment mechanisms to assist the operator in adjusting the catheter position and ultimately confirming the implantation site. This invention balances the safety of uterine cavity operations with the level of visual site selection.

Description

Technical Field

[0001] This invention relates to the field of gynecological intrauterine diagnostic and therapeutic instruments, specifically to a multifunctional visual intrauterine operating system and its control method. Background Technology

[0002] In vitro fertilization-embryo transfer (IVF-ET) is one of the main techniques for treating infertility. During IVF-ET, an embryo transfer catheter loaded with the embryo is inserted into the uterine cavity through the vagina and cervix, and the embryo is released at a suitable site in the endometrium. The appropriateness of the embryo release site has a certain impact on the embryo implantation rate.

[0003] Currently, the commonly used embryo transfer guidance methods in clinical practice mainly include the following: The first method is blind embryo transfer. The doctor inserts the embryo transfer catheter manually into the uterine cavity at a predetermined depth based on their experience, and then injects the embryo to release it. This method relies entirely on the surgeon's experience and is prone to problems such as inaccurate catheter insertion depth, endometrial damage, and misalignment of the released embryo.

[0004] The second method is ultrasound-guided embryo transfer. Doctors use abdominal ultrasound images to observe the approximate location of the transfer catheter within the uterus to guide embryo release. This is currently the mainstream method, but abdominal ultrasound images have limited resolution, only showing the general location of the embryo transfer catheter and failing to clearly display the fine morphology of the endometrium. Doctors cannot actively select the optimal implantation site with clearly defined blood vessels and appropriate thickness within the endometrium.

[0005] The third method is transvaginal ultrasound-guided transplantation. This method has limited imaging angles and requires precise patient positioning.

[0006] The fourth method is hysteroscopic-assisted embryo transfer. This method uses a traditional hysteroscope to directly observe the uterine cavity, which can obtain clear images of the uterine cavity. However, the traditional hysteroscope has a complex structure and a large outer diameter, making it unsuitable for direct use at the moment of embryo release. In addition, the hysteroscope needs to continuously inject distending fluid into the uterine cavity during operation, which carries the risk of the distending fluid washing away the embryo.

[0007] In addition, there are a few existing technologies that integrate the camera directly into the embryo transfer catheter. However, most of these solutions do not specifically address the problem of the uterine cavity contracting naturally under foreign body stimulation and the uterine wall pressing tightly against the camera lens, which limits the imaging field of view. In actual operation, it is still difficult to obtain a clear and stable field of view. A few other solutions have an inflatable balloon at the front end of the catheter. However, the balloon is mainly used to keep the outer tube in the uterine cavity to prevent the embryo from being expelled, or to carry the embryo and attach it to the endometrium. The balloon is not designed to accommodate the camera's field of view and cannot expand the imaging space for the camera.

[0008] Even with the aforementioned integrated camera solution that obtains real-time images, existing methods often rely on the surgeon's subjective interpretation to determine implantation sites, or use a simple judgment logic based on a single feature and a single fixed threshold (e.g., determining site suitability based on whether a certain indicator exceeds a fixed threshold). This overly simplistic judgment logic has significant drawbacks: it is prone to misjudgment under interference from image noise, transient artifacts, or specular reflection; it is prone to repeated switching and inconsistent judgment results in critical regions near the threshold; it lacks temporal consistency verification of multiple frames, and even a single frame's occasional good result can trigger false confirmation; furthermore, the fixed threshold lacks adaptability to changes in image quality, and the threshold set under clear images becomes invalid when image quality deteriorates, resulting in unstable site selection results and poor repeatability.

[0009] Furthermore, in existing image-assisted solutions, the functions of forming and maintaining imaging conditions, image quality assessment, and site discrimination are often independent and lack correlation: once the expansion or inflation used to form the observation space is set, it is maintained in an open loop, and image processing only passively receives the obtained images. When the imaging conditions deteriorate due to uterine contractions, leakage of expansion media, or changes in patient position, image processing cannot react to the imaging conditions to restore image quality, which leads to a decrease in the reliability of site discrimination when imaging quality fluctuates, or even the inability to stably confirm sites for a long time.

[0010] On the other hand, in clinical practice of embryo transfer, to improve endometrial receptivity and increase embryo implantation rate, pre-transfer endometrial treatment is sometimes necessary. This includes: applying moderate stimulation to the endometrium through mechanical curettage (i.e., scraping) to promote implantation; injecting stem cells, platelet-rich plasma, growth factors, or immunomodulators into the endometrium or myometrium; infusing appropriate fluids or medications into the uterine cavity; and applying microcurrent stimulation to the endometrium. However, these pre-transfer treatments are currently mostly performed separately from embryo transfer, using different instruments. For example, a curettage may be performed on a separate day before transfer, followed by the transfer itself. Furthermore, curettage and injection procedures are often performed blindly without direct visualization, making it difficult to target specific areas based on the real-time morphology of the endometrium. Repeated entry into the uterine cavity and blind manipulation of the entire cavity also increase endometrial damage.

[0011] In summary, existing embryo transfer guidance methods either have limited imaging resolution, pose a risk of the distending fluid washing away the embryo, or struggle to provide a stable imaging field of view for the camera. They generally employ overly simplistic judgment logic for site identification, and their imaging condition maintenance and image discrimination functions are independent and unrelated, making it difficult to simultaneously address the needs for visual active site selection, the reliability of identification, and embryo safety during the embryo transfer process. Furthermore, pre-implantation treatments such as curettage, injection, perfusion, and electrical stimulation of the endometrium are often performed in stages and blindly, and current technologies lack a method that can perform these treatments as needed based on real-time observation of the endometrium during the same visualization instrument and the same entry process, and then immediately perform embryo transfer. Summary of the Invention

[0012] The purpose of this invention is to provide a multifunctional visual intrauterine operating system and its control method, solving the technical problems in existing intrauterine operations (especially embryo transfer) that make it difficult to simultaneously meet the needs of active endometrial visualization and selection with operational safety (especially embryo safety); the overly simplistic site discrimination logic leading to misjudgments and instability; and the fact that existing solutions involve independent and unrelated functions such as the formation and maintenance of imaging conditions, image quality assessment, and site discrimination, with imaging conditions being maintained in an open loop once set, and image processing unable to reflect back on the imaging conditions to restore image quality when imaging deteriorates. Furthermore, this invention aims to enable the same system to perform various intrauterine operations such as endometrial curettage, injection, perfusion, and electrical stimulation as needed under direct vision based on real-time observation of the endometrial condition, while simultaneously achieving the aforementioned active embryo transfer visualization. This replaces the existing segmented, blind processing methods, reducing endometrial damage caused by repeated entry into the uterine cavity.

[0013] In a first aspect, the present invention provides a multifunctional visual uterine cavity operating system, comprising: The catheter body has a wall including an inner wall and an outer wall, with a cavity formed between the inner wall and the outer wall, and the inner wall enclosing a working channel. A camera module and a signal transmission line electrically connected to the camera module are disposed in the interlayer cavity at the front end of the catheter body. The working channel has an outlet at the front end of the catheter body that avoids the camera module. A flexible expansion assembly is disposed at the front end of the catheter body. The flexible expansion assembly forms a sealed filling cavity with the outer wall. After the flexible expansion assembly is filled and expanded in the filling cavity, it forms an observation cavity within the field of view of the camera module. A filling channel communicating with the filling cavity; An operating handle is connected to the catheter body; the signal transmission line and the filling channel are both arranged in the interlayer cavity and extend to the operating handle; An image acquisition module, which is connected to the camera module, is used to acquire real-time images of the endometrium captured by the camera module; A filling control unit, which is connected to the filling channel, is used to adjust the filling pressure of the expansion medium injected into the flexible expansion component through the filling channel, so as to adjust the observation cavity formed by the flexible expansion component pushing open the uterine wall within the field of view of the camera module. An image processing module is connected to both the image acquisition module and the filling control unit. The image processing module is configured to: determine an image quality metric based on the real-time image; extract feature quantities of each candidate region in the real-time image and calculate site suitability; perform temporal smoothing on the site suitability to obtain smoothed site suitability; adaptively determine a decision threshold based on the image quality metric; and output planting site confirmation information based on the smoothed site suitability and the decision threshold. The filling pressure adjusted by the filling control unit determines the geometry of the observation cavity, which in turn affects the image quality metric determined by the image processing module. The image processing module outputs a filling adjustment signal to the filling control unit based on the image quality metric to adjust the filling pressure, so that the image quality metric tends to the target image quality metric, thereby forming a closed loop between the filling pressure and the image quality metric.

[0014] Furthermore, the flexible expansion component is an annular expandable membrane, which is circumferentially disposed around the outer wall of the catheter body. The annular expandable membrane has a front edge and a rear edge along the axial direction of the catheter body. The front edge and the rear edge are sealed to the outer wall by bonding or hot-melt welding, so that an annular filling cavity is formed between the annular expandable membrane and the outer wall.

[0015] Furthermore, the flexible expansion assembly is located 3mm to 8mm behind the camera module along the axial direction of the catheter body. The maximum outer diameter of the flexible expansion assembly after the filling cavity is filled and expanded is 5mm to 8mm, so that the flexible expansion assembly forms the observation cavity in front of the camera module after filling and expanding. The flexible expansion assembly is made of at least one material selected from medical silicone, medical polyurethane, or medical polyethylene film. A filling hole is opened on the outer wall corresponding to the position of the filling cavity, and the filling channel communicates with the filling cavity through the filling hole.

[0016] Furthermore, the operating handle is provided with an instrument insertion port communicating with the working channel and a filling interface communicating with the filling channel; the filling interface is a Luer interface, and the filling interface is used to connect an external syringe, infusion set or constant temperature liquid supply device; an external signal interface is provided on the side of the operating handle near the instrument insertion port, and the external signal interface is electrically connected to a signal transmission line.

[0017] Furthermore, a constant temperature heating module is provided between the filling interface and the filling channel. The constant temperature heating module is used to heat the medium injected through the filling interface to 36°C to 38°C before injecting it into the filling channel.

[0018] Furthermore, the operating handle is provided with a drain valve, one end of which is connected to the filling channel and the other end is connected to the drain port provided on the outer shell of the operating handle, for discharging the medium in the filling chamber to the outside of the operating handle.

[0019] Furthermore, the filling control unit includes a pressure sensor, a controllable injection component, and a filling control circuit. The controllable injection component is connected to the filling channel via the filling interface. The pressure sensor is used to detect the filling pressure of the filling chamber. The filling control circuit controls the controllable injection component to adjust the filling pressure according to the filling adjustment signal, and limits the filling pressure between a preset lower pressure limit and a preset upper pressure limit. The image acquisition module includes an image acquisition interface connected to the external signal interface. The image acquisition interface is used to transmit the real-time image acquired by the camera module to the image processing module.

[0020] Furthermore, the catheter body also has a front end section, a pre-shaped curved section and a rear end section. The pre-shaped curved section is located between the front end section and the rear end section of the catheter body that connects to the operating handle. The bending angle of the pre-shaped curved section is 10° to 30°. The pre-shaped curved section and the flexible expansion assembly are spaced 5cm to 10cm apart along the axial direction of the catheter body. The pre-shaped curved section is used to conform to the physiological curvature of the human uterine cavity.

[0021] Furthermore, the inner wall of the front end segment and the front end portion of the outer wall of the front end segment are integrally formed into a transparent end cover using transparent medical polymer material. The outer surface of the transparent end cover has a rounded, blunt-headed shape, and the internal space of the transparent end cover is an extension and sealed cavity of the interlayer cavity at the front end of the front end segment. The camera module is encapsulated within the internal space of the transparent end cover. One end of the signal transmission line is electrically connected to the camera module, and the other end is introduced into the interlayer cavity through the internal space of the transparent end cover and extends along the interlayer cavity to the operating handle.

[0022] Furthermore, the camera module is a CMOS digital camera, and the signal transmission line is an electrical wire.

[0023] Furthermore, the outer diameter of the catheter body is no greater than 4 mm, the total axial length of the catheter body is 20 cm to 30 cm, and the end face of the front end section is a rounded blunt tip; the inner and outer walls of the catheter body are both made of medical polymer, including at least one of medical polyethylene, medical polyurethane, and medical silicone, wherein the front end portion of the inner wall and the outer wall of the front end section is made of transparent medical polymer material.

[0024] Secondly, based on the above system, the present invention also provides a control method for a multifunctional visual uterine cavity operating system. The control method is executed by the image acquisition module, image processing module, and filling control unit of the system, and includes the following steps: S1, the image acquisition module acquires a real-time image of the endometrium collected by the camera module within the observation cavity formed by the expansion and expansion of the flexible expansion component; S2, the image processing module determines the image quality metric based on the real-time image, extracts the feature quantities of each candidate region in the real-time image and calculates the site suitability, and performs temporal smoothing on the site suitability to obtain the smoothed site suitability; S3, the image processing module generates a filling adjustment signal based on the image quality metric and outputs it to the filling control unit, so that the filling control unit adjusts the filling pressure of the expansion medium according to the filling adjustment signal, causing the image quality metric to tend towards the target image quality metric; wherein the filling pressure determines the geometry of the observation cavity, thereby affecting the image quality metric of the real-time image subsequently acquired by the image acquisition module, thus forming a closed loop between the filling pressure and the image quality metric; S4, the image processing module adaptively determines a decision threshold based on the image quality metric, and the decision threshold increases as the image quality metric decreases, and outputs visual guidance information for guiding the adjustment of the circumferential orientation and insertion depth of the catheter body; when the suitability of the smoothing site of a candidate region is not less than the decision threshold, the candidate region is locked; when the suitability of the smoothing site of the locked candidate region is lower than the hysteresis lower limit threshold, the locking is released, and the hysteresis lower limit threshold is less than the decision threshold; S5, when the number of frames in which the suitability of the smoothing site of the locked candidate region is not less than the decision threshold reaches the required number of frames, the image processing module outputs implantation site confirmation information to indicate that the position corresponding to the locked candidate region is a suitable embryo implantation site; wherein the required number of frames increases as the image quality metric decreases.

[0025] Furthermore, the filling adjustment signal adjusts the filling pressure. Determine using the following formula: In the formula, The frame number, For the first The corresponding filling pressure of the frame For the quality measurement of the target image, For the first Image quality metrics for frames The feedback gain is greater than 0; when the image quality metric Smaller than the target image quality metric Increase the filling pressure and the filling pressure It is limited to between the preset lower pressure limit and the upper pressure limit.

[0026] Further, the image processing module executes according to a finite state machine, which includes a search state, a candidate locking state, a stability confirmation state, and a site confirmation output state. In the search state, when the smooth site suitability of a candidate region is not less than the decision threshold, the module transitions to the candidate locking state and locks the candidate region. In the candidate locking state, if the smooth site suitability of the locked candidate region is continuously not less than the decision threshold, the module transitions to the stability confirmation state; if it is lower than the hysteresis lower limit threshold, the module unlocks and returns to the search state. In the stability confirmation state, the module accumulates a number of frames for the locked candidate region. When the number of frames reaches the required number, the module transitions to the site confirmation output state; if the smooth site suitability is lower than the decision threshold during this period, the module returns to the candidate locking state. In the site confirmation output state, the planting site confirmation information is output.

[0027] Furthermore, the site fitness The vascular texture feature values ​​of each candidate region in the real-time image are determined as follows: Thickness-related characteristic quantities and surface flatness characteristics Only when Falling into the preset allowable range and , If each candidate region's value is not less than its respective lower threshold, the candidate region passes the gating process; candidate regions that fail the gating process are not included in subsequent decisions. The site suitability of the gating candidate regions is calculated using the following formula. : In the formula, , , The vascular texture features, thickness-related features, and surface smoothness features are normalized to 0 to 1. , , These are the corresponding weight coefficients. This is the bias value. The fitness of the site is a natural constant. The value ranges from 0 to 1, and it has a saturation suppression effect on outliers of a single feature.

[0028] Furthermore, the decision threshold According to the image quality metric, the following formula is used: Adaptive adjustment: In the formula, As the baseline threshold, For adaptive gain, The image quality metric is defined as having a value ranging from 0 to 1; the smoothing site suitability is defined as... The fitness of the site is calculated frame by frame using the following formula. Perform exponentially weighted smoothing: In the formula, The frame number, For the first Frame smoothing site suitability, For the first Frame site suitability, The smoothing coefficient and The image processing module outputting the planting site confirmation information must also meet the image stability metric of the real-time image. Not greater than the stability threshold The image stability metric This refers to the statistical measure of grayscale changes in corresponding regions between adjacent frames of the real-time image.

[0029] The core mechanism of this invention can be summarized in the following five points: First, the flexible expansion component only expands the local uterine wall within the field of view of the camera module. The expansion medium is physically isolated from the uterine cavity through the sealed filling cavity, eliminating the need for continuous perfusion of distending fluid into the entire uterine cavity. This fundamentally avoids the risk of the distending fluid and embryo carrier fluid mixing and washing away the embryo.

[0030] Second, the flexible expansion component pushes open the observation cavity formed by the inner wall of the uterus within the field of view of the camera module, providing a stable and repeatable local space for endometrial imaging. This allows the image processing module to reliably extract and determine features of the endometrium without the inner wall of the uterus being close to the lens and without image shake.

[0031] Third, addressing the shortcomings of existing functions being independent and unrelated, this invention deeply integrates filling control and image processing into a closed loop: On one hand, the filling pressure regulated by the filling control unit determines the geometry of the observation cavity, thereby determining the clarity and stability of endometrial imaging, which in turn affects the image quality metric determined by the image processing module. That is, filling pressure acts as both input and constraint, influencing the image quality metric. On the other hand, the image processing module applies the determined image quality metric inversely to the filling control unit. When the image quality metric is lower than the target image quality metric, the filling adjustment signal is increased or the filling pressure is adjusted to restore the geometry of the observation cavity to a state conducive to imaging, and the image quality metric recovers. That is, the state of the image quality metric inversely affects the behavior of the filling pressure. Thus, a closed-loop dependency is formed between filling pressure and image quality metric, and the two must work together as an organic whole and cannot be separated in isolation. This closed loop brings unexpected technical effects that cannot be obtained by implementing either feature alone: ​​if there is only filling control without image quality feedback, the filling is maintained in an open loop, and the observed cavity will drift due to uterine contractions, media leakage, or changes in body position, resulting in image degradation; if there is only image quality adaptive decision and the filling pressure is fixed, the decision can only wait or reject more conservatively when the image continues to deteriorate, and cannot improve the image, or even confirm the site for a long time; however, after the two are coupled in a closed loop, the decision loop actively maintains the image quality, so that the site discrimination can still obtain clear and stable images under the above disturbances and complete the confirmation stably and quickly, reducing the confirmation failure and stagnation caused by image degradation and shortening the confirmation time.

[0032] Fourth, based on the stable imaging maintained by the above closed loop, this invention mainly uses feature gating, nonlinear weighted fusion, and exponentially weighted temporal smoothing (consistent multi-frame consistency verification) to suppress site misjudgment, false confirmation, and repeated switching of critical regions caused by occasional good single-frame performance; and makes the decision threshold for site discrimination adaptively change with the imaging quality: the decision threshold increases as the image quality metric decreases, the required number of frames for confirmation also increases as the image quality metric decreases, and a hysteresis lower limit threshold is set below the decision threshold. The locking is only released when the suitability of the smoothed site in the locked candidate region falls below the hysteresis lower limit threshold, so as to further supplement the suppression of repeated switching of critical regions; the above steps can be implemented by feature gating, nonlinear weighted fusion, exponentially weighted smoothing, and finite state machines.

[0033] Fifth, the site identification and guidance of the present invention are completed by the image processing module, while the actual adjustment of the catheter position is still manually completed by the surgeon holding the operating handle. The closed loop only acts on the imaging conditions such as filling pressure and observation cavity, without the need for automatic servoing or follow-up driving of the catheter position. The site image identification and embryo release are decoupled in time. The surgeon first confirms the embryo implantation site based on the identification and guidance, and then pushes the embryo transfer catheter through the outlet to release the embryo. The temperature of the expansion medium can be controlled between 36°C and 38°C. The double-walled sandwich structure of the catheter body completely physically isolates the working channel from all lines and fluid pathways, ensuring that the embryo and its carrier fluid are not contaminated.

[0034] Compared with the prior art, the present invention has the following beneficial effects: Firstly, this invention integrates a camera module at the front end of the catheter body, enabling doctors to directly obtain real-time images of the endometrium. This allows them to actively select sites with regular shape, appropriate thickness, and clear vascular patterns as embryo implantation sites, which helps improve the embryo implantation rate.

[0035] Secondly, the present invention sets up a flexible expansion component within the field of view of the camera module, which only partially opens the inner wall of the uterus to form an observation cavity. It does not rely on the overall perfusion of the uterine cavity with distending fluid, thus avoiding the risk of the distending fluid washing away the embryo, and allowing visualization and embryo safety to be taken into account at the same time.

[0036] Third, this invention deeply integrates filling control and image processing into a closed loop between filling pressure and image quality measurement. The decision loop actively adjusts the filling pressure based on the image quality measurement to maintain the imaging conditions of the observation cavity. Compared with the existing schemes that maintain imaging conditions in an open loop while image processing only passively receives images, this invention can actively recover and maintain image quality under disturbances such as uterine contractions, media leakage, or changes in body position. This reduces site confirmation failures and stagnation caused by imaging degradation and shortens confirmation time. Moreover, this effect cannot be achieved by implementing filling control or image quality adaptive decision alone. For comparison and evaluation methods, please refer to the specific implementation method in the specification.

[0037] Fourth, this invention primarily uses exponentially weighted temporal smoothing of site suitability and continuous multi-frame consistency verification to reduce site misjudgment and false confirmation caused by single-frame noise and transient interference, and significantly suppresses repeated switching of the critical region. On this basis, the decision threshold and the number of frames required for confirmation are both increased as the image quality metric decreases, and a hysteresis lower limit threshold less than the decision threshold is used to further suppress repeated switching and false confirmation of the critical region. Compared with simple decision based on a single fixed threshold, this invention improves the robustness and repeatability of site discrimination.

[0038] Fifth, the catheter position adjustment of this invention is still completed by the operator manually holding the entire operating handle. The closed loop does not act on the catheter position, maintaining the characteristics of simple catheter structure and single use. Site identification and embryo release are decoupled, with site selection before release, and the embryo release action does not disturb the confirmed site. The filling medium temperature is maintained at 36°C to 38°C, and the double-walled sandwich structure completely isolates the working channel from all lines and fluid pathways, ensuring that the embryo and its carrier fluid are not contaminated during the transfer process.

[0039] Sixth, the system's working channel allows for the passage of instruments such as embryo transfer catheters, and replaceable instruments such as scraping, injection, irrigation, and electrical stimulation can be inserted through the same channel. This enables visualized and active selection of embryo transfer sites, and allows for various intrauterine procedures such as endometrial scraping, injection, irrigation, and electrical stimulation as needed, based on real-time observation of the endometrium within the observation cavity formed by the camera module's direct visualization and flexible expansion components. Compared to existing pre-transfer treatments that often require multiple, blind procedures, this system can complete these procedures in a single entry into the uterine cavity before embryo transfer, reducing endometrial damage caused by repeated entries and blind operations. All the aforementioned procedures and corresponding replaceable instruments are optional applications of this system and do not affect its basic structure and function for embryo transfer. Attached Figure Description

[0040] Figure 1 This is a schematic diagram of the overall structure of the multifunctional visual uterine operating system provided in Embodiment 1 of the present invention; Figure 2 This is a cross-sectional view of the overall structure of the multifunctional visual uterine cavity operating system provided in Embodiment 1 of the present invention; Figure 3 The catheter body tip segment in the multifunctional visual uterine operating system provided in Embodiment 1 of the present invention ( Figure 1 Enlarged view of a portion of the area at point A (middle section); Figure 4 The catheter body tip segment in the multifunctional visual uterine operating system provided in Embodiment 1 of the present invention ( Figure 2 Enlarged view of a section at point B (middle part); Figure 5 This is a partial cross-sectional view of the rear end section of the catheter body and the operating handle in the multifunctional visual intrauterine operating system provided in Embodiment 1 of the present invention; Figure 6 This is a schematic diagram of several variations of the replaceable scraper head in the multifunctional visual uterine operating system provided in Embodiment 1 of the present invention; Figure 7 This is a connection diagram of the multifunctional visual uterine operating system module provided in Embodiment 4 of the present invention; Figure 8The flowchart shows the control method of the multifunctional visual uterine operating system provided in Embodiment 4 of the present invention.

[0041] Explanation of reference numerals in the attached drawings: 1—Catheter body; 1a—Front end section; 1b—Pre-formed curved section; 1c—Rear end section; 11—Inner wall; 12—Outer wall; 13—Intercalation cavity; 14—Outlet; 15—Transparent end cap; 16—Filling port; 17—Filling cavity; 2—Camera module; 3—Working channel; 4—Signal transmission line; 5—Flexible expansion assembly; 5a—Annular expandable membrane; 6—Filling channel; 7—Operating handle; 71—Filling interface; 72—Drainage valve; 73—Instrument insertion port; 8—Embryo transfer catheter; 9—External display device. Detailed Implementation

[0042] The present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only for explaining the present invention and are not intended to limit the present invention. It should be noted that terms such as "front," "back," "inner," and "outer" used in this specification are used only for the purpose of clarity of description and are not intended to limit the scope of the present invention.

[0043] Example 1 like Figures 1 to 5 As shown, this embodiment provides the hardware component of a multifunctional visual uterine cavity operating system. The hardware component includes a catheter body 1, a camera module 2, a flexible expansion component 5, an infusion channel 6, and an operating handle 7. The system also includes an image acquisition module, an infusion control unit, and an image processing module. The specific structure of these three modules and their connection relationship with the aforementioned hardware component are detailed in Embodiment 3. The camera module 2 is a CMOS camera module with built-in LED illumination. When the camera module 2 is working, the LED provides illumination to the observed area within the uterine cavity.

[0044] The catheter body 1 comprises, along its axial direction, a front end segment 1a, a pre-shaped curved segment 1b, and a rear end segment 1c. The end face of the front end segment 1a is rounded to facilitate entry into the uterine cavity through the vagina and cervix while avoiding tissue damage. The outer diameter of the catheter body 1 is 4 mm, and the total axial length of the catheter body 1 is 25 cm. The pre-shaped curved segment 1b is located between the front end segment 1a and the rear end segment 1c, and its bending angle is 15°. The pre-shaped curved segment 1b is designed to conform to the physiological curvature of the human uterine cavity.

[0045] like Figure 1As shown, the catheter body 1 has an inner wall 11 and an outer wall 12, with a cavity 13 formed between the inner wall 11 and the outer wall 12. A camera module 2 is arranged in the cavity 13 at the front end of the catheter body 1. The hollow cavity formed by the inner wall 11 constitutes a working channel 3, which extends through the catheter body 1 along its axial direction. Both the inner wall 11 and the outer wall 12 are made of medical-grade polyethylene. The inner wall 11 has a wall thickness of 0.3 mm, the outer wall 12 has a wall thickness of 0.4 mm, and the radial thickness of the cavity 13 is 0.3 mm to 0.5 mm. The inner wall 11 and the outer wall 12 are integrally formed by co-extrusion. The inner diameter of the working channel 3 is 1.5 mm. In this embodiment, the embryo transfer catheter 8 is a thin-diameter transfer tube with an outer diameter of no more than 1.5 mm, which matches the currently commonly used thin-diameter embryo transfer inner tubes and can be pushed through the working channel 3. The replacement instruments such as scrapers and injection devices that are inserted through the working channel 3 as described below also have an outer diameter of no more than 1.5 mm to ensure that they can pass through the working channel 3 smoothly.

[0046] like Figure 1 , Figure 3 As shown, the front end of the working channel 3 opens at the front end of the front end segment 1a to form an outlet 14. The outlet 14 and the camera module 2 are located in different areas at the front end of the front end segment 1a. The outlet 14 is offset from the center of the field of view of the camera module 2 and does not obstruct the field of view of the camera module 2. The opening size of the outlet 14 matches the inner diameter of the working channel 3, so that after the embryo transfer catheter 8 is pushed along the working channel 3 to the front end segment 1a, it can extend forward along the catheter body 1 through the outlet 14 and release the embryo to the endometrial target site in front of the field of view of the camera module 2.

[0047] The inner wall 11 and the front end portion of the outer wall 12 of the front end segment 1a are integrally formed from medical transparent polycarbonate (PC) to form a transparent end cover 15. The integral molding process adopts co-extrusion hot melt molding or blow molding. The outer surface of the transparent end cover 15 is a rounded arc, forming the rounded outer surface of the front end of the front end segment 1a on the side where the camera module 2 is located; the front end of the front end segment 1a is generally rounded to reduce mechanical stimulation to tissues when inserted into the cervix and uterine cavity. The cross-section of the front end segment 1a is non-circular, and the working channel 3 is located in the middle of the cross-section. The inner wall 11, the interlayer cavity 13, and the outer wall 12 are arranged sequentially around the working channel 3. The signal transmission line 4 and the filling channel 6 are arranged in the interlayer cavity 13; wherein, on the side where the camera module 2 is located, the outer wall 12 and the interlayer cavity 13 protrude outward to expand the internal space of the transparent end cover 15 to accommodate the camera module 2. Figure 3As shown in the diagram, the opposite side is not protruding but relatively flat, ensuring that the maximum outer diameter of the front end section 1a is no more than 4mm while accommodating the camera module 2. The internal space of the transparent end cover 15 is an extension and sealed cavity of the interlayer cavity 13 at the front end of the front end section 1a. The front end of the working channel 3 opens at the front end of the front end section 1a to form an outlet 14. The internal spaces of the working channel 3 and the transparent end cover 15 are isolated from each other by the inner wall 11 and are not interconnected. The embryo transfer catheter 8 is pushed along the axial direction of the catheter body 1 through the working channel 3 and extends forward from the outlet 14. The one-piece molding process forms a seamless, integral sealed structure at the front end of the front end section 1a, with the inner wall 11, outer wall 12, and interlayer cavity 13, avoiding the risk of leakage of expansion media or uterine cavity fluid that may exist at the adhesive seams. The camera module 2 is encapsulated within the internal space of the transparent end cover 15, and the space between the camera module 2 and the inner wall of the transparent end cover 15 is filled and encapsulated with medical-grade silicone or epoxy resin. One end of the signal transmission line 4 is electrically connected to the camera module 2, and the other end is introduced from the internal space of the transparent end cover 15 into the interlayer cavity 13 and extends rearward along the interlayer cavity 13 to the operating handle 7. The transparent end cover 15 protects the camera module 2 from contact with intrauterine fluid and tissue and provides an optical transmission window. The camera module 2 is a CMOS digital camera with 3 megapixels.

[0048] like Figure 2 , Figure 3 As shown, the signal transmission line 4 is a composite electrical conductor. Internally, the signal transmission line 4 includes an image signal line electrically connected to the camera module 2 and a power supply line electrically connected to the camera module 2. The signal transmission line 4 extends along the interlayer cavity 13 to the external signal interface of the operating handle 7. The external signal interface is used to connect to an external display device 9 or an external power supply, transmitting the image signals acquired by the camera module 2 to the display device 9 for display.

[0049] like Figure 2 and Figure 4 As shown, the flexible expansion component 5 in this embodiment adopts an annular expandable membrane 5a. The annular expandable membrane 5a is made of medical-grade silicone, and its thickness is 0.1 mm to 0.3 mm. The annular expandable membrane 5a is circumferentially disposed around the outer wall 12 of the catheter body 1, and is located 8 mm behind the camera module 2 along the axial direction of the catheter body 1. The annular expandable membrane 5a has a front edge and a rear edge along the axial direction of the catheter body 1. Both the front edge and the rear edge are sealed to the outer wall 12 with medical-grade silicone adhesive, so that an annular sealed filling cavity 17 is formed between the annular expandable membrane 5a and the outer wall 12.

[0050] A filling hole 16 is provided on the outer wall 12 at the position corresponding to the filling cavity 17. The filling hole 16 penetrates the outer wall 12 radially, so that the filling cavity 17 is connected to the filling channel 6 arranged in the interlayer cavity 13. The filling channel 6 is a micro-tube set in the interlayer cavity 13. The front end of the filling channel 6 is connected to the filling cavity 17 through the filling hole 16, and the rear end of the filling channel 6 extends to the filling interface 71 on the operating handle 7.

[0051] The annular expandable membrane 5a, when not filled, adheres to the outer wall 12, and its outer diameter is basically the same as that of the catheter body 1. When filled, the annular expandable membrane 5a expands outward, and the maximum outer diameter after expansion is 5mm to 8mm, which is 6mm in this embodiment. The raised structure formed by the annular expandable membrane 5a after filling is located within the field of view of the camera module 2, which pushes open the uterine wall within the field of view of the camera module 2 to form an observation cavity. Since the uterine cavity is a collapsed cavity with the anterior and posterior walls attached to each other in its natural state, the annular expandable membrane 5a only needs to push open the local uterine wall close to the lens by a few millimeters to form a clear observation cavity. Therefore, its filling pressure is only to form an observation cavity, and there is no need to expand the entire uterine cavity under high pressure, thereby avoiding excessive compression of the endometrium.

[0052] It should be noted that the geometric relationship regarding "the annular expandable membrane 5a being located within the field of view of the camera module 2" in this embodiment is as follows: The camera module 2 is positioned at the end face of the front end segment 1a, with its lens facing the front of the catheter body 1 to image the uterine cavity. The field of view of the camera module 2 is a conical spatial region extending along the front of the catheter body 1 with the lens of the camera module 2 as its apex. The axial position of the annular expandable membrane 5a on the catheter body 1 is located 8 mm behind the proximal side of the camera module 2 (i.e., the side closest to the operating handle 7). However, when the annular expandable membrane 5a is in the inflated state, it expands radially outward along the catheter body 1 to a maximum outer diameter of 6 mm. The expanded annular expandable membrane 5a pushes the circumferential uterine wall outward, causing the part of the front of the camera module 2 that would normally be close to the lens due to the contraction of the uterine wall to be pushed open by the annular expandable membrane 5a to form an observation cavity, which is located within the field of view of the camera module 2. In other words, in this embodiment, "located within the field of view of the camera module" means that the observation cavity formed by the annular expandable membrane 5a in the filled state is located within the field of view of the camera module 2, while the axial installation position of the annular expandable membrane 5a itself on the conduit body 1 is on the proximal side of the camera module 2.

[0053] like Figure 5 As shown, the operating handle 7 is connected to the rear end section 1c of the catheter body 1. The operating handle 7 includes an operating handle housing, and is provided with a filling port 71, a drain valve 72, an instrument insertion port 73, and an external signal interface.

[0054] The filling interface 71 is a Luer interface, which is connected to the rear end of the filling channel 6. The filling interface 71 is used to connect an external syringe, infusion set or constant temperature liquid supply device.

[0055] A drain valve 72 is located on a branch between the filling port 71 and the filling channel 6. One end of the drain valve 72 is connected to the filling channel 6, and the other end is connected to a drain port on the outer shell of the operating handle 7. It is used to drain the medium in the filling chamber 17 to the outside of the operating handle 7. The drain valve 72 is used to quickly recover the medium in the filling chamber 17 before withdrawing the device, so that the annular expandable membrane 5a quickly retracts and adheres to the outer wall 12 when the drain valve 72 is opened.

[0056] The instrument insertion port 73 is located at the center of the tail end of the operating handle 7. The instrument insertion port 73 is coaxially connected with the working channel 3. The instrument insertion port 73 is used for inserting the embryo transfer catheter 8, so that the embryo transfer catheter 8 is pushed forward along the working channel 3 to the front end segment 1a and the embryo is released through the outlet 14.

[0057] The external signal interface is located on the operating handle 7 near the instrument insertion port 73. The external signal interface is electrically connected to the signal transmission line 4 and is used to connect an external display device 9.

[0058] The working components within the working channel 3 of this system are not limited to the aforementioned cylindrical embryo transfer catheter 8, but can also be replaced with various scraping heads for endometrial curettage. Each scraping head is mounted at the distal end of the operating rod and is inserted through the working channel of this system, just like the embryo transfer catheter 8. Each scraping head is made of elastically deformable metal wire or elastic medical material, and during insertion through the working channel 3, it retracts or flattens so that its maximum radial dimension does not exceed the inner diameter of the working channel 3 (1.5 mm in Example 1), thus allowing it to pass smoothly through the working channel 3. After the distal end of the scraping head extends to the end of the device, it elastically recovers and unfolds into a shape for scraping. For scraping heads with a larger unfolded size, such as double-ring heads, the two rings retract and extend before unfolding again when passing through the working channel 3. When pre-implantation treatments such as curettage are required, a scraping head of the appropriate shape is inserted through the working channel, with its distal end extending to the end of the system. Under the direct view of the camera module 2, the endometrium is scraped. After scraping, the scraping head is withdrawn from the working channel and then replaced with the embryo transfer catheter 8 through the same channel to complete the embryo transfer. Figure 6 Several variations of the scraper head are shown.

[0059] like Figure 6As shown, the first type of scraper head, the willow-leaf ring scraper head, is made of metal wire bent into a closed ring shape, with an overall shape of willow leaf or teardrop. Its distal end narrows into a pointed tip, while the proximal end is wider, and it is connected to the operating rod via a connecting part. The center of the ring is hollowed out; it is used to scrape the endometrium with its ring edge. The second type of scraper head, the circular scraper head, is nearly circular (round or elliptical), connected to the operating rod via a gradually narrowing neck and connecting part. It can be a closed ring, or a round spoon or disc with a scraping surface. It is used to gently scrape a smaller area of ​​the endometrium with its circular edge or spoon surface for targeted scraping. The third type of scraper head, the double-ring scraper head, consists of two willow-leaf rings arranged side by side. The two rings extend symmetrically from the connecting part to the distal end, forming a wider double-leaf scraping surface with a larger hollowed-out area. It can be used to scrape a larger area at once with the parallel double-ring edges, or the ring closest to the endometrium can be selected for scraping under direct vision.

[0060] It is understood that the shape of the scraper is not limited to the three mentioned above. It can also be a smooth shape with more rings side by side or other shapes that are easy to scrape and cause less damage to the endometrium. As long as it can be installed on the operating rod and inserted through the working channel to scrape the endometrium under direct vision, it falls within the protection scope of this application.

[0061] It should be noted that the visualization transfer system provided in this embodiment is not limited to the single purpose of embryo transfer. With the help of the camera system integrated at its end and the working channel for instruments to pass through, the system essentially constitutes a multifunctional platform that can operate on the uterine cavity under direct vision: by changing different built-in instruments in the same working channel, various intrauterine operations other than embryo transfer can be completed under the same external catheter and the same entry path, thereby allowing for targeted pre-transfer treatments based on the real-time observation of the uterine cavity during a single entry.

[0062] One application of this system is for endometrial curettage (i.e., scraping). Specifically, a brush, curette (scalpel), or metal ring is inserted into the working channel, and under direct visualization with a camera system, moderate mechanical stimulation is applied to the endometrium, especially the endometrium at the intended implantation site, to promote embryo implantation. Because the entire procedure is performed under direct visualization, the operator can perform localized scraping only on the observed target area, without blindly scraping the entire uterine cavity. This significantly reduces damage to the endometrium while achieving the goal of stimulating it. After scraping, the scraping instrument is withdrawn from the working channel, and the embryo transfer catheter is inserted through the same channel to complete the transfer. This eliminates the need for multiple procedures as in traditional methods (e.g., curettage one day, transfer the next), avoiding the additional damage and stimulation caused by repeated entry into the uterine cavity.

[0063] In addition to endometrial curettage, this system, with the aid of the aforementioned replaceable internal instruments, can also perform one or more of the following intrauterine procedures under direct visualization: First, injection, where an injection device is inserted through the working channel to inject stem cells, platelet-rich plasma, growth factors, or immunomodulators into the endometrium or myometrium at specific points; second, perfusion, where appropriate fluids or medications are infused into the uterine cavity; and third, electrical stimulation, where microcurrents are applied to the endometrium. All of the above procedures share the same external catheter and entry path as embryo transfer, and are all performed under real-time observation by the camera system. The operator can independently select and sequentially perform curettage, brushing, injection, perfusion, or electrical stimulation before embryo transfer, based on the observed uterine cavity condition.

[0064] Therefore, this system is no longer limited to the single function of embryo transfer, but forms an instrument platform that integrates visual observation and various intrauterine operations: users can insert instruments with corresponding functions through the same working channel and use them under direct vision according to actual needs. After use, they can be removed and replaced with other instruments or inserted with a transfer tube, thus completing the entire operation process of pre-transfer assessment, endometrial treatment and embryo transfer with the same system.

[0065] The working process of the multifunctional visual uterine cavity operating system provided in this embodiment is as follows: First, connect the external signal interface to the external display device 9, check that the camera module 2 is working properly, and confirm that the annular expandable film 5a is undamaged.

[0066] In the second step, the doctor holds the operating handle 7 and inserts the tip 1a of the catheter body 1 into the uterine cavity through the vagina and cervix. Since the outer diameter of the catheter body 1 is 4mm and the tip 1a is blunt, in most cases it can be directly inserted through the cervix with the guidance of the blunt tip. For cases with greater insertion resistance, such as cervical stenosis, nulliparity, or cervical tortuosity, routine pretreatment of the cervix can be performed before insertion, such as preoperative softening or moderate mechanical dilation to a degree suitable for the outer diameter of the catheter body 1, so that the catheter body 1 can smoothly pass through the cervix and enter the uterine cavity. During insertion, visual navigation is provided based on the real-time images displayed on the display device 9.

[0067] The third step involves injecting preheated saline solution (preheated to 37°C) into the filling port 71 as a dilation medium after the front end segment 1a enters the uterine cavity. Preheating can be achieved using a hospital-provided constant-temperature water bath, constant-temperature infusion warmer, or constant-temperature perfusion pump to stabilize the saline solution within the range of 36°C to 38°C before injection through the filling port 71. (Compared to room-temperature saline solution, carbon dioxide distension gas, or other cold media used in traditional hysteroscopy, the temperature of the warm saline solution is close to the patient's body temperature, reducing cold stimulation and smooth muscle reflex contractions in the uterine cavity.) The warm saline solution enters the filling cavity 17 through the filling channel 6 and filling hole 16. The annular expandable membrane 5a expands outward, opening the uterine wall within the field of view of the camera module 2 to form an observation cavity. Because the filling cavity 17 is completely isolated from the uterine cavity by the annular expandable membrane 5a, the warm saline solution will not enter the uterine cavity, avoiding liquid perfusion to the release area at the end of the working channel 3.

[0068] The fourth step involves the doctor adjusting the circumferential orientation and insertion depth of the device by holding the overall operating handle 7, and then conducting a systematic observation of the endometrium.

[0069] In the fifth step, laboratory personnel insert the embryo transfer catheter 8 containing the embryo into the working channel 3 through the instrument insertion port 73, and slowly push the embryo transfer catheter 8 to the front end segment 1a. The front end of the embryo transfer catheter 8 extends through the outlet 14 to the target position in front of the camera module 2, and the embryo is injected and released.

[0070] Step 6: After releasing the embryo, hold it for more than 30 seconds, then slowly pull back the embryo transfer catheter 8 to confirm that there is no embryo residue.

[0071] Step 7: Open the drain valve 72 to drain the saline solution in the filling chamber 17. The annular expandable membrane 5a retracts and adheres to the outer wall 12.

[0072] Step 8: Disconnect the external signal interface from the external display device 9, and slowly withdraw the conduit body 1. The operation is complete.

[0073] Through the above structure and operation process, the multifunctional visual uterine cavity operating system provided in this embodiment realizes the active visual selection of the endometrium during embryo transfer. It also forms an observation cavity locally through the annular expandable membrane 5a, avoiding the risk of continuous perfusion of distending fluid, thus simultaneously ensuring visualization and embryo safety. Since the inner wall 11 of the working channel 3 is completely physically isolated from all circuits and media pathways in the interlayer cavity 13, and the working channel 3 is in a one-time sealed state after being sterilized with ethylene oxide before leaving the factory, it only comes into contact with the sterile embryo transfer catheter 8 during use, ensuring that the embryo and its carrier fluid are not contaminated during the transfer process.

[0074] Example 2 The difference between this embodiment and Embodiment 1 is that a constant temperature heating module is provided between the filling interface 71 and the filling channel 6. The remaining structures of the catheter body 1, camera module 2, flexible expansion component 5, and operating handle 7 in this embodiment are the same as those in Embodiment 1.

[0075] Specifically, the constant temperature heating module is located inside the operating handle 7. The module includes a heating chamber, a temperature sensor, and a temperature control circuit. The input end of the heating chamber is connected to the filling interface 71, and the output end is connected to the filling channel 6. The temperature sensor is attached to the outer wall of the output end of the heating chamber. The temperature control circuit is integrated on a circuit board inside the operating handle 7. The temperature control circuit controls the heating power of the heating chamber based on the temperature sensor's measurement value, ensuring the output temperature of the heating chamber is stably controlled within the range of 36℃ to 38℃. The constant temperature heating module is powered by an external display device 9 or an external power supply via the power supply line in the external signal interface.

[0076] During use, room temperature saline solution is injected into the filling port 71. The room temperature saline solution is heated to 36°C to 38°C by the constant temperature heating module and then enters the filling chamber 17 through the filling channel 6.

[0077] The advantages of the multifunctional visual intrauterine operating system provided in this embodiment are: the operator does not need to prepare a constant temperature fluid supply device in advance, but only needs to inject room temperature saline into the filling port 71 to obtain a filling medium with a stable temperature, which simplifies the preoperative preparation process and further improves the patient's comfort during the dilation process.

[0078] Example 3 The difference between this embodiment and Embodiment 1 lies in the axial installation position of the annular expandable membrane 5a and the expansion size after filling; the rest of the structure is the same as in Embodiment 1. In this embodiment, the annular expandable membrane 5a is located 3mm behind the camera module 2 along the axial direction of the conduit body 1, and the maximum outer diameter of the annular expandable membrane 5a after expansion in the filling state is 8mm.

[0079] Because the annular expandable membrane 5a is closer to the lens of the camera module 2 (3mm behind) and expands more after filling (the maximum outer diameter after expansion is 8mm, that is, it expands radially outward by about 2mm on one side based on the 4mm outer diameter of the catheter body 1), the bulge formed by the annular expandable membrane 5a pushing open the uterine wall is closer to the lens and the opening amplitude is greater, and the axial depth of the observation cavity formed in front of the camera module 2 is correspondingly increased. In the configuration of this embodiment, the axial depth of the observation cavity in front of the lens of the camera module 2 is about 1mm to 2mm, which can meet the depth of field requirements of the camera module 2 for clear imaging of the target site of the endometrium. The camera module 2 adopts a macro imaging module with a minimum focusing distance not greater than the depth of the observation cavity, or a fixed-focus module with a corresponding depth of field, so as to clearly image the endometrium at a distance of 1mm to 2mm in front of the lens; if necessary, the wall thickness of the transparent end cap 15 can be included in the focusing optical path of the lens.

[0080] This embodiment is applicable to situations where the endometrium is thick, the collapse is tight, or a larger field of view is required. In practical applications, the axial position (3mm to 8mm behind the camera module 2) and the expansion size (maximum outer diameter after expansion, 5mm to 8mm) of the annular expandable membrane 5a can be selected within the range defined in the claims, depending on the degree of collapse of the uterine cavity and imaging needs. The closer the position is to the lens and the greater the expansion, the deeper the observation cavity formed in front of the lens.

[0081] Example 4 like Figure 7 , Figure 8As shown, this embodiment, based on the hardware of Embodiment 1 or Embodiment 2, further includes an image acquisition module, an infusion control unit, and an image processing module. These modules are all located in an external control unit (such as a trolley-type main unit or a processing unit integrated with an external display device 9), and are not integrated into the catheter body inserted into the uterine cavity. The catheter body only carries components such as the camera module, signal transmission line, infusion channel, and flexible expansion assembly, and is connected to the external image acquisition / processing module and infusion control unit via the external signal interface and infusion interface 71 on the operating handle 7, respectively. This constitutes a multifunctional visual uterine cavity operating system and provides a visual auxiliary control method based on real-time image feedback. The image acquisition module includes an image acquisition interface or image acquisition card connected to an external signal interface. Real-time images acquired by camera module 2 are transmitted to the external signal interface via signal transmission line 4, and then transmitted by the image acquisition module to the image processing module. The filling control unit includes a pressure sensor, a controllable injection component (e.g., an electronically controlled injection pump or proportional valve), and a filling control circuit. The controllable injection component is connected to the filling channel 6 via filling interface 71 and is used to adjust the filling pressure of the expansion medium. The image processing module can be integrated into the external display device 9, or it can be set as an independent image processing unit between the external display device 9 and the external signal interface. After processing the real-time image frame by frame, the image processing module sends the image, current status, and guidance information to the external display device 9 for display, and outputs a filling adjustment signal to the filling control unit. Both the image processing module and the filling control unit can be implemented by a general-purpose processor, embedded processing unit, or computer executing corresponding programs, thus forming a complete closed-loop control path for image acquisition, transmission, processing, and filling.

[0082] In this embodiment, all feature quantities, image quality metrics, and image stability metrics can be calculated using conventional image processing methods in the art. Examples are as follows: vascular texture feature quantity. Normalized statistics of the response values ​​of candidate regions after vascular enhancement filtering (such as Frangi vascular filtering or Gabor filtering) can be obtained; thickness-related features. The surface smoothness feature can be obtained by edge detection of the upper and lower boundaries of the endometrial layer, calculating the pixel distance between the boundaries using the known outer diameter of the catheter body 1 as a calibration scale, and then normalizing it; The normalized reciprocal of the surface fitting residual or local gradient variance within the candidate region can be used; image quality metric It can be obtained by normalizing and weighting image sharpness (such as the variance of the Laplacian operator response or the Tenengrad gradient energy) and image contrast (such as the root mean square contrast); image stability metric The mean of the absolute values ​​of the grayscale differences between corresponding regions of adjacent frames or the statistical measure of optical flow amplitude can be taken. The extraction of the above-mentioned features and measures are all conventional algorithms already existing in this field, and those skilled in the art can implement them based on these algorithms without any creative effort.

[0083] The control method in this embodiment uses a finite state machine consisting of a search state, a candidate locking state, a stability confirmation state, and a site confirmation output state. It performs multi-level nested decision-making on the image in each frame. The specific steps are as follows.

[0084] The following steps S1 to S5 are complete process examples including clinical operations. The in vitro steps (image acquisition, image quality measurement and site suitability calculation, filling pressure closed loop, adaptive decision and confirmation output) executed by the system module correspond to S1 to S5 of this control method (i.e., steps S1 to S5). Inserting the catheter into the uterine cavity, filling and expanding to form an observation cavity, and manual fine-tuning of the catheter by the operator are clinical operations that are in conjunction with this method and do not constitute steps of the above control method.

[0085] Step S1: Connect the external signal interface to the external display device 9, check that the camera module 2 is working properly and confirm that the annular expandable membrane 5a is undamaged; the doctor holds the operating handle 7 and inserts the front end 1a of the catheter body 1 into the uterine cavity through the vagina and cervix. The image processing module is initialized to search mode and performs visual navigation based on the real-time images displayed on the external display device 9.

[0086] In step S2, after the front end segment 1a enters the uterine cavity, the filling control unit injects preheated warm saline solution (preheated to 37°C) into the filling cavity 17 via the filling interface 71, filling channel 6, and filling hole 16 as an expansion medium. The annular expandable membrane 5a expands outward, opening up the uterine wall within the field of view of the camera module 2 to form an observation cavity, thereby obtaining a stable real-time image of the endometrium. Since the filling cavity 17 is completely isolated from the uterine cavity by the annular expandable membrane 5a, the warm saline solution will not enter the uterine cavity.

[0087] Step S3: The image processing module performs multi-level nested decision-making on the real-time image frame by frame. The first level is feature gating: extracting vascular texture features from each candidate region within the field of view. Thickness-related characteristic quantities and surface flatness characteristics And normalize to 0 to 1, only when Falling into the preset allowable range and , Candidate regions are gated if their values ​​are not less than their respective lower thresholds. In this embodiment, the allowable range is 0.3 to 0.9, and the lower threshold is 0.4 for all regions. Candidate regions can be obtained by dividing the real-time image into grids, using sliding windows, or segmenting the image within the field of view of the camera module. Each candidate region corresponds to a region of endometrium to be evaluated. The second level is nonlinear weighted fusion: the site suitability of the gated candidate regions is calculated using the following formula. .

[0088] In this embodiment, the weight is w. v =2.0、w h =2.0、w u =1.0, bias b=2.4 (so that the site fitness S in the gated area can reach about 0.92, which is higher than the upper limit of the decision threshold τ of 0.8, ensuring that there are identifiable sites under all imaging qualities). This logistic mapping makes the site fitness S have a saturation suppression effect on outliers of a single feature, avoiding the judgment of high site fitness just because a single index is occasionally too high. The third level is temporal consistency verification: for frame-by-frame site fitness The fitness of smoothed sites is obtained by performing exponential weighted smoothing according to the following formula. .

[0089] In this embodiment, the smoothing coefficient is taken as... Simultaneously, the image processing module calculates image quality metrics based on the image sharpness and contrast of the real-time image. And adaptively adjust the decision threshold according to the following formula .

[0090] In this embodiment, the reference threshold is taken as... Adaptive gain selection Image quality metric The lower the judgment threshold The higher the required frame rate, the better in terms of image quality. When the quality is high, take 15 frames and use image quality metrics. Increase the stability threshold to 30 frames when the frame rate is low. The upper limit of the grayscale change statistics of adjacent frames is taken as the preset upper limit, and the lower limit of the hysteresis threshold is taken as the decision threshold. Decrease by 0.1.

[0091] For example, taking a gated candidate region , , Then its site fitness In image quality measurement At that time, the decision threshold The hysteresis lower limit threshold is 0.54. The suitability of the smoothing site in this candidate region, after exponential weighted smoothing, stabilizes at approximately 0.82 and remains no less than the decision threshold from the 7th frame onwards. This meets the required frame count of 15 consecutive frames and the image stability metric is also met. Not greater than the stability threshold Then, around frame 22, the planting site confirmation information is output.

[0092] Simultaneously with the aforementioned judgment, this embodiment establishes a closed loop between the filling pressure and image quality measurement using an image processing module and a filling control unit: the image processing module calculates the image quality measurement according to the following formula. Adjust the filling pressure applied by the filling control unit. .

[0093] In the formula, The frame number, For the first Frame filling pressure, For the measurement of target image quality, this embodiment takes The feedback gain is set to γ ​​= 0.5 (in kPa, representing the filling pressure adjustment per unit of image quality metric deviation), and the filling pressure p is limited to between 3 kPa and 8 kPa. With a typical image quality metric deviation of 0.1 to 0.2, the closed loop can cumulatively generate approximately 0.75 kPa to 3 kPa of filling pressure adjustment within 15 to 30 frames during a single site confirmation, sufficient to restore the imaging conditions of the observed cavity. When the observed cavity shrinks due to uterine contractions or media leakage, or the uterine wall approaches the lens, affecting image quality metric deviation... Decreased and below the target image quality metric At that time, the filling control unit increases the filling pressure according to the above formula, causing the annular expandable membrane 5a to further push open the uterine wall and restore the observation cavity, thus improving image quality. It then rebounds; conversely, when image quality measures... When the pressure exceeds the target value, reduce the charging pressure appropriately to avoid over-expansion. Therefore, the charging pressure... The determination of the cavity geometry affects the image quality metric. Image quality measurement The charging pressure is then adjusted in reverse according to the above formula. The two form a closed loop and cannot be separated in isolation; at the same time, image quality measurement It is used to adaptively adjust the decision threshold and affect the required number of frames, so that the imaging quality, decision threshold and confirmation strictness are linked.

[0094] It should be noted that the above-mentioned closed-loop adjustment of filling pressure is only used to form and maintain the imaging condition of the observation cavity required for endometrial imaging, and does not adjust the position of the catheter body 1 in the uterine cavity. The circumferential orientation and insertion depth of the catheter body 1 are always manually adjusted by the operator. The technical effect brought about by this closed loop is something that cannot be achieved by implementing filling control alone or image quality adaptive decision alone: ​​if the filling pressure is fixed (open loop), the observation cavity will drift with uterine contraction, leakage or changes in body position, and the image quality metric will remain low. Simply increasing the decision threshold and the number of frames required can only make the confirmation more conservative or even make it impossible to confirm the site for a long time. However, after the observation cavity is actively restored by the above-mentioned closed loop, the image quality metric can be maintained at a high level, and the decision loop can quickly and stably complete the site confirmation.

[0095] In step S4, the image processing module transitions between states of the finite state machine based on the results of multi-level nested decisions and outputs visual guidance information. In the search state, the external display device 9 displays the suitability of smoothing sites in each candidate region. The surgeon is guided to the appropriate smooth site using directional indicators. Higher area adjustment; the doctor holds the operating handle 7 according to the directional instructions and manually fine-tunes the circumferential orientation and insertion depth of the catheter body 1 to ensure that the field of view of the camera module 2 is oriented towards a suitable smooth site. A higher degree of endometrial lining. When the suitability of a candidate region's smoothness site is satisfied... When the state machine transitions from the search state to the candidate locking state and locks the candidate region, if the suitability of the smoothing site in the locked candidate region is not less than the decision threshold, it transitions to the stability confirmation state. If the suitability of the smoothing site falls below the hysteresis lower limit threshold or the feature gating no longer passes, it unlocks and reverts to the search state, thereby avoiding repeated switching of the critical region.

[0096] Step S5: In the stability confirmation state, the image processing module accumulates the number of sustained frames for the locked candidate regions. ,when To reach the required frame rate Smooth site suitability is continuously satisfied And image stability metrics Not greater than the stability threshold When the process begins, the state machine transitions to the site confirmation output state, where the image processing module outputs implantation site confirmation information on the external display device 9, indicating that the endometrial location corresponding to the currently locked candidate region is a suitable embryo implantation site. If the image stability metric is not met during this process, the process reverts to the candidate locking state or search state for re-determination. The required number of frames... With image quality metrics Decreasing the image quality requires increasing the number of consecutive frames for verification, meaning that lower image quality necessitates higher image quality. This concludes the image processing and visualization guidance process involved in this control method.

[0097] To illustrate the technical improvement of the composite decision logic compared to the single fixed threshold discrimination scheme, under the same endometrial imaging conditions, the decision logic of this embodiment can be compared and evaluated with the control scheme based on indicators such as site misjudgment rate, number of repeated switching of critical zone state, and false confirmation rate under low image quality metric conditions.

[0098] Specifically, the above comparative evaluation, under the same imaging conditions, uses offline playback and numerical simulation to ensure that each compared scheme receives identical image frames and interference inputs such as noise, transient artifacts, and specular reflections, thus comparing only the differences in the decision logic itself. The evaluation samples cover two types of imaging conditions: high image quality metric (smaller required frame count) and low image quality metric (larger required frame count). Each type of imaging condition includes several independent site confirmation processes, and each indicator is the statistical average of multiple independent evaluations. The meanings of each indicator are as follows: the site misclassification rate is the proportion of samples whose implantation site confirmation information output by each scheme indicates a site that is not a true suitable site out of the total number of samples with output confirmation information; the critical zone state switching count is the average number of times locking and unlocking (in the control scheme without locking logic, the currently selected candidate region changes) occurs for the critical zone candidate region during a single site confirmation process; the misclassification rate under low image quality metric conditions is the proportion of samples whose implantation site confirmation information output by the low image quality metric indicates an unsuitable site.

[0099] To examine the role of each decision-making step, the control schemes are set up from simple to complex as follows: Control Scheme 1 extracts only a single feature and makes a decision on a single frame image using a single fixed threshold; Control Scheme 2 uses the aforementioned multi-feature nonlinear weighted fusion to obtain site suitability, but still makes a decision on a single frame image using a single fixed threshold; Control Scheme 3 adds exponential weighted temporal smoothing of site suitability to Control Scheme 2 and requires a certain number of consecutive fixed frames to meet the threshold, but its decision threshold is fixed and no hysteresis lower limit threshold is set; Control Scheme 4 changes the decision threshold and the required number of frames to be adaptive with the image quality metric, but no hysteresis lower limit threshold is set, and no image stability metric verification is performed; The scheme in this embodiment further sets a hysteresis lower limit threshold that is less than the decision threshold and requires the image stability metric to be no greater than the stability threshold, based on the adaptive decision threshold and the adaptive required number of frames, thus forming a complete composite decision logic.

[0100] Among them, multi-feature nonlinear weighted fusion mainly reduces repeated switching of the critical zone by saturating and suppressing outliers of single feature quantities; exponential weighted temporal smoothing of site suitability and continuous multi-frame confirmation significantly reduce misjudgment and false confirmation caused by accidental good single frames through temporal consistency verification; the decision threshold and the required number of frames are adaptive with the image quality metric, further suppressing false confirmation caused by the failure of the fixed threshold when the image quality metric decreases; the hysteresis lower limit threshold below the decision threshold and the image stability metric verification further suppress repeated switching of the critical zone and false confirmation caused by interference from strong specular reflection, transient artifacts, etc., lasting for several frames. It can be seen that the simultaneous improvement of the above three indicators stems from the synergistic effect of the above decision steps. It is impossible to obtain the improvement of the above three indicators simultaneously by using any one of the steps alone. Thus, the composite decision logic of this embodiment has a technical effect on suppressing site misjudgment, repeated switching of the critical zone, and false confirmation of low image quality compared with a single fixed threshold discrimination scheme, and improves the robustness and repeatability of site discrimination.

[0101] To fully illustrate the clinical use of this system, the following are the follow-up procedures performed by the surgeon after the implantation site has been confirmed using the control method described above. These follow-up procedures are performed by the physician and laboratory personnel and are not part of the control method described above: After the implantation site confirmation information is output by the external display device 9, the laboratory personnel insert the embryo transfer catheter 8 containing the embryo into the working channel 3 through the instrument insertion port 73. The embryo transfer catheter 8 is slowly pushed to the front end 1a, so that its front end extends through the outlet 14 to the confirmed site in front of the camera module 2's field of view, and the embryo is injected and released. After the embryo is released, it is held for more than 30 seconds, and the embryo transfer catheter 8 is slowly pulled back to confirm that there is no embryo residue. Then, the drainage valve 72 is opened to drain the saline in the filling chamber 17, and the annular expandable membrane 5a retracts and adheres to the outer wall 12. Finally, the connection between the external signal interface and the external display device 9 is disconnected, and the catheter body 1 is slowly withdrawn. The operation is complete.

[0102] Through the closed-loop of filling pressure and image quality measurement, and the decision and control process that adapts the decision threshold to the imaging quality and is combined with a hysteresis mechanism, this embodiment, based on the hardware visualization active location selection and local expansion to ensure embryo safety in Embodiments 1 and 2, actively adjusts the filling pressure according to the image quality measurement to maintain the imaging conditions of the observation cavity. The decision threshold and the required number of frames are adapted to the image quality measurement, and the lower limit of hysteresis suppresses critical jitter. With the help of feature gating, nonlinear weighted fusion, exponential weighted smoothing and finite state machine, it can still actively maintain image quality and stably and quickly complete site confirmation under disturbances such as uterine contraction, media leakage or changes in body position. This improves the robustness and repeatability of site discrimination. Moreover, the adjustment of the catheter position is manually completed by the operator throughout the process. The closed loop does not act on the catheter position, maintaining the characteristics of disposable catheter, low cost and single-person operation.

[0103] The above are merely specific embodiments of the present invention and are not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A multifunctional visual uterine cavity operating system, characterized in that, include: The catheter body (1) has an inner wall (11) and an outer wall (12) with a cavity (13) formed between the inner wall (11) and the outer wall (12), and the inner wall (11) forms a working channel (3). The camera module (2) and the signal transmission line (4) electrically connected to the camera module (2) are disposed in the interlayer cavity (13) at the front end of the catheter body (1). The working channel (3) has an outlet (14) at the front end of the catheter body (1) that avoids the camera module (2). Flexible expansion component (5) is disposed at the front end of the catheter body (1). A closed filling cavity (17) is formed between the flexible expansion component (5) and the outer wall (12). After the flexible expansion component (5) is filled and expanded in the filling cavity (17), it forms an observation cavity within the field of view of the camera module (2). A filling channel (6) connected to the filling cavity (17); The operating handle (7) is connected to the catheter body (1), the signal transmission line (4) and the filling channel (6) are both arranged in the interlayer cavity (13) and extend to the operating handle (7). An image acquisition module is connected to the camera module (2) and is used to acquire real-time images of the endometrium collected by the camera module (2). The filling control unit is connected to the filling channel (6) and is used to adjust the filling pressure of the expansion medium injected into the flexible expansion component (5) through the filling channel (6) so as to adjust the observation cavity formed by the flexible expansion component (5) pushing open the uterine wall within the field of view of the camera module (2). An image processing module is connected to both the image acquisition module and the filling control unit. The image processing module is configured to: determine an image quality metric based on the real-time image; extract feature quantities of each candidate region in the real-time image and calculate site suitability; perform temporal smoothing on the site suitability to obtain smoothed site suitability; adaptively determine a decision threshold based on the image quality metric; and output planting site confirmation information based on the smoothed site suitability and the decision threshold. The filling pressure adjusted by the filling control unit determines the geometry of the observation cavity, which in turn affects the image quality metric determined by the image processing module. The image processing module outputs a filling adjustment signal to the filling control unit based on the image quality metric to adjust the filling pressure, so that the image quality metric tends to the target image quality metric, thereby forming a closed loop between the filling pressure and the image quality metric.

2. The multifunctional visual uterine cavity operating system according to claim 1, characterized in that, The flexible expansion component (5) is an annular expandable membrane (5a). The annular expandable membrane (5a) is arranged around the outer wall (12) along the circumference of the catheter body (1). The annular expandable membrane (5a) has a front edge and a rear edge along the axial direction of the catheter body (1). The front edge and the rear edge are sealed to the outer wall (12) by bonding or hot-melt welding, so that the annular expandable membrane (5a) and the outer wall (12) form an annular filling cavity (17). The flexible expansion component (5) is located behind the camera module (2) along the axial direction of the catheter body (1). The flexible expansion component (5) is made of at least one material selected from medical silicone, medical polyurethane or medical polyethylene film. A filling hole (16) is opened on the outer wall (12) at the position corresponding to the filling cavity (17). The filling channel (6) is connected to the filling cavity (17) through the filling hole (16).

3. The multifunctional visual uterine cavity operating system according to claim 1, characterized in that, The operating handle (7) is provided with an instrument insertion port (73) communicating with the working channel (3) and a filling interface (71) communicating with the filling channel (6); the filling interface (71) is a Luer interface, and the filling interface (71) is used to connect an external syringe, infusion set or constant temperature liquid supply device; an external signal interface is provided on the side of the operating handle (7) near the instrument insertion port (73), and the external signal interface is electrically connected to the signal transmission line (4); a constant temperature heating module is provided between the filling interface (71) and the filling channel (6), and the constant temperature heating module is used to heat the medium injected through the filling interface (71) to 36°C to 38°C before injecting it into the filling channel (6).

4. The multifunctional visual uterine cavity operating system according to claim 1, characterized in that, The operating handle (7) is provided with a drain valve (72). One end of the drain valve (72) is connected to the filling channel (6), and the other end is connected to the drain port provided on the outer shell of the operating handle (7), which is used to discharge the medium in the filling chamber (17) to the outside of the operating handle (7).

5. The multifunctional visual uterine cavity operating system according to claim 1, characterized in that, The catheter body (1) has a front end section (1a), a pre-formed curved section (1b), and a rear end section (1c). The pre-formed curved section (1b) is located between the front end section (1a) and the rear end section (1c) of the catheter body (1) connecting to the operating handle (7). The front end portion of the inner wall (11) and the outer wall (12) of the front end section (1a) is integrally formed from transparent medical polymer material to form a transparent end cap (15). The outer surface of the transparent end cap (15) is rounded and blunt. The internal space of the transparent end cap (15) is an extended sealed cavity of the interlayer cavity (13) at the front end of the front end section (1a). The camera module ( 2) Encapsulated within the internal space of the transparent end cover (15), the camera module (2) is a CMOS digital camera, the signal transmission line (4) is an electrical wire, one end of the signal transmission line (4) is electrically connected to the camera module (2), and the other end is introduced into the interlayer cavity (13) through the internal space of the transparent end cover (15) and extends along the interlayer cavity (13) to the operating handle (7); the end face of the front end section (1a) is a rounded blunt head; the inner wall (11) and outer wall (12) of the catheter body (1) are both made of medical polymer, including at least one of medical polyethylene, medical polyurethane and medical silicone.

6. A control method for a multifunctional visual intrauterine operating system, wherein the control method employs the multifunctional visual intrauterine operating system as described in any one of claims 1 to 5, and the control method is executed by the system's image acquisition module, image processing module, and filling control unit, characterized in that... Includes the following steps: S1, the image acquisition module acquires a real-time image of the endometrium collected by the camera module (2) within the observation cavity formed by the expansion and expansion of the flexible expansion component (5); S2, the image processing module determines the image quality metric based on the real-time image, extracts the feature quantity of each candidate region in the real-time image and calculates the site suitability, and performs temporal smoothing on the site suitability to obtain the smoothed site suitability; S3, the image processing module generates a filling adjustment signal based on the image quality metric and outputs it to the filling control unit, so that the filling control unit adjusts the filling pressure of the expansion medium according to the filling adjustment signal and makes the image quality metric tend towards the target image quality metric; The filling pressure determines the geometry of the observation cavity, which in turn affects the image quality metric of the real-time images subsequently acquired by the image acquisition module, thus forming a closed loop between the filling pressure and the image quality metric. S4, the image processing module adaptively determines the decision threshold based on the image quality metric, and the decision threshold increases as the image quality metric decreases, and outputs visual guidance information for guiding the adjustment of the circumferential orientation and insertion depth of the catheter body (1); when the suitability of the smoothing site of a candidate region is not less than the decision threshold, the candidate region is locked; when the suitability of the smoothing site of the locked candidate region is lower than the hysteresis lower limit threshold, the locking is released, and the hysteresis lower limit threshold is less than the decision threshold; S5, when the number of frames in which the suitability of the smoothing site of the locked candidate region is not less than the decision threshold reaches the required number of frames, the image processing module outputs implantation site confirmation information to indicate that the position corresponding to the locked candidate region is a suitable embryo implantation site; wherein the required number of frames increases as the image quality metric decreases.

7. The control method for the multifunctional visual uterine operating system according to claim 6, characterized in that, The filling adjustment signal adjusts the filling pressure. Determine by the following formula: In the formula, The frame number, For the first The corresponding filling pressure of the frame For the quality measurement of the target image, For the first Image quality metrics for frames The feedback gain is greater than 0; when the image quality metric Smaller than the target image quality metric Increase the filling pressure and the filling pressure It is limited to between the preset lower pressure limit and the upper pressure limit.

8. The control method for the multifunctional visual uterine operating system according to claim 6, characterized in that, The image processing module executes according to a finite state machine, which includes a search state, a candidate locking state, a stability confirmation state, and a site confirmation output state. In the search state, when the smooth site suitability of a candidate region is not less than the decision threshold, the module transitions to the candidate locking state and locks the candidate region. In the candidate locking state, if the smooth site suitability of the locked candidate region is continuously not less than the decision threshold, the module transitions to the stability confirmation state. If it is lower than the hysteresis lower limit threshold, the module unlocks and returns to the search state. In the stability confirmation state, the module accumulates a number of frames for the locked candidate region. When the number of frames reaches the required number, the module transitions to the site confirmation output state. If the smooth site suitability is lower than the decision threshold during this period, the module returns to the candidate locking state. In the site confirmation output state, the module outputs the planting site confirmation information.

9. The control method for the multifunctional visual uterine operating system according to claim 6, characterized in that, The site suitability The vascular texture feature values ​​of each candidate region in the real-time image are determined as follows: Thickness-related characteristic quantities and surface flatness characteristic quantity Only when Falling into the preset allowable range and , If each candidate region's value is not less than its respective lower threshold, the candidate region passes the gating process; candidate regions that fail the gating process are not included in subsequent decisions. The site suitability of the gating candidate regions is calculated using the following formula. : In the formula, , , The vascular texture features, thickness-related features, and surface smoothness features are normalized to 0 to 1. , , These are the corresponding weight coefficients. This is the bias value. The fitness of the site is a natural constant. The value ranges from 0 to 1, and it has a saturation suppression effect on outliers of a single feature.

10. The control method for the multifunctional visual uterine operating system according to claim 6, characterized in that, The decision threshold According to the image quality metric, the following formula is used: Adaptive adjustment: In the formula, As the baseline threshold, For adaptive gain, The image quality metric is defined as having a value ranging from 0 to 1; the smoothing site suitability is defined as... The fitness of the site is calculated frame by frame using the following formula. Perform exponentially weighted smoothing: In the formula, The frame number, For the first Frame smoothing site suitability, For the first Frame site suitability, The smoothing coefficient and The image processing module outputting the planting site confirmation information must also meet the image stability metric σ of the real-time image. img Not greater than the stability threshold The image stability metric σ img This refers to the statistical measure of grayscale changes in corresponding regions between adjacent frames of the real-time image.

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