A handheld modular intelligent anoscope and its operating system

Abstract

This application belongs to the field of medical devices and relates to a handheld modular intelligent anoscope, including a main unit, an anoscope, and a disposable sterile adapter assembly that can be modularly connected to the main unit. The main unit includes a housing, a male threaded block, a high-definition camera, and a ring light disposed on the housing. The housing also integrates a snapshot switch, a lighting and recording switch, a USB-C interface, and a status display screen. The disposable sterile adapter assembly includes an examination adapter, a surgical adapter, and a pediatric adapter, for selecting one of the adapters to connect to the male threaded block of the main unit in different diagnostic and treatment modes, and to cooperate with the anoscope. This application also relates to an operating system, including an application running on a mobile terminal and a cloud platform. The technical solution provided by this application can achieve highly portable and wireless operation of the device while ensuring zero contact and infection prevention, and deeply integrate intelligent diagnostic and data management functions.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a handheld modular intelligent anoscope and its operating system. Background Technology

[0002] Anoscopy is a basic tool used in proctology to diagnose diseases such as hemorrhoids, anal fissures, and rectal polyps. Currently, the commonly used equipment in clinical practice mainly includes traditional anoscopes and electronic anoscopes. However, both types of equipment have significant shortcomings. Traditional anoscopes are usually made of metal or disposable plastic. Although they are simple in structure, low in cost, and easy to operate, the equipment is highly dependent on external light sources and the doctor's subjective observation. The accuracy of diagnosis is significantly affected by human factors.

[0003] Furthermore, traditional anoscopes cannot record imaging data, which limits the objective retrospection of the disease and cannot provide effective support for medical teaching and remote consultation, making it difficult to meet the current requirements of precision medicine and digital medical records.

[0004] Although existing electronic anoscopes have built-in light sources and cameras, enabling real-time observation and recording of internal images, they still have many problems.

[0005] The camera component of the electronic anoscope often comes into direct contact with the patient's body cavity, or indirectly through parts that are difficult to thoroughly disinfect, posing a high potential risk of cross-infection. Furthermore, the device typically uses a trolley design and is wired, limiting its movement in outpatient clinics or at the bedside. In addition, the electronic anoscope has limited functionality, providing only image display and lacking intelligent auxiliary functions and data management capabilities deeply integrated with the diagnostic process. Coupled with the high price of the entire device and the significant maintenance and disinfection costs, these factors pose challenges to the widespread adoption of electronic anoscopes in primary healthcare institutions. Summary of the Invention

[0006] The purpose of this invention is to provide a handheld modular intelligent anorectal endoscope and system. Through architectural design, the device achieves high portability and wireless operation while ensuring zero contact and infection prevention. It also deeply integrates intelligent diagnostic and data management functions to comprehensively improve the efficiency and quality of diagnosis and treatment of anorectal diseases.

[0007] To achieve the above objectives, the present invention adopts the following technical solution: a handheld modular intelligent anoscope, comprising a main unit, an anoscope, and a disposable sterile adapter assembly that can be modularly connected to the main unit; The host includes a housing, and a male threaded block, a high-definition camera and a ring light disposed on the housing; The housing also integrates a snapshot switch, a lighting and recording switch, a USB-C interface, and a status display screen; The disposable sterile adapter assembly includes an examination adapter, a surgical adapter, and a pediatric adapter, which are used to select one of the adapters to connect to the male threaded block of the main unit under different diagnostic and treatment modes, and cooperate with the anoscope to form a physical isolation between the main unit and the patient's body cavity.

[0008] As a further description of the above technical solution: the inspection adapter includes a light guide structure, a limiting baffle connected to the light guide structure, and a fixing ring that fixes the light guide structure by a reinforcing plate.

[0009] As a further description of the above technical solution: the center of the fixing ring is provided with a female thread groove that seamlessly connects with the male thread block of the host, and the light guide structure is configured to be able to be embedded in the barrel of the anoscope along a straight line.

[0010] As a further description of the above technical solution: when the light guide structure is inserted, the limiting baffle abuts against the edge of the proximal end of the anoscope barrel.

[0011] As a further description of the above technical solution: the surgical adapter includes a fixing part and an adjustable support part; The fixing part includes an arc-shaped lens that fits into the inner wall of the anoscope barrel, a straight-plate lens that fits into the anoscope handle, and a locking block provided on the straight-plate lens for fixing to the locking hole of the handle. The adjustable support includes a diagonal brace connected to the straight-plate lens, and a fixed cylinder mounted on the diagonal brace via a column; The fixed cylinder is provided with a female thread groove that is connected to the male thread block.

[0012] As a further description of the above technical solution: the child-type adapter includes a miniaturized light guide structure and a widened limiting baffle to prevent over-insertion, wherein the outer diameter of the miniaturized light guide structure is smaller than that of the light guide structure of the inspection adapter; The widened limiting baffle is fixedly connected to the miniature light guide structure.

[0013] An operating system includes a handheld modular smart anoscope, and also includes an application running on a mobile terminal and a cloud platform, the operating system comprising: User Login and Device Management: Used for account verification and login, it uses wireless communication technology to pair and connect with the host, and displays the battery level and status information of the host's status display screen in the application interface, and synchronizes the patient queue list. Real-time image acquisition and operation control layer: used to receive and display video stream data acquired by high-definition cameras; provide virtual buttons corresponding to the snapshot switch and lighting recording switch, and send dimming commands to the host to adjust the brightness of the ring fill light; Intelligent Assisted Diagnosis Layer: Utilizes a built-in deep learning model to perform real-time inference calculations on the received video frames, identify lesions and generate lesion classification labels and confidence information, and transparently overlay the identification results onto the original video screen in an augmented reality manner; Electronic medical record reporting layer: In response to the instructions of the capture switch or corresponding virtual button, it extracts the captured image and its corresponding lesion structured label, automatically fills it into the preset structured report template, and generates an electronic diagnostic report; Data synchronization service layer: used to upload encrypted electronic diagnostic reports and image data to the cloud platform via API gateway for classification, storage and data processing.

[0014] As a further description of the above technical solution: In the intelligent auxiliary diagnosis layer, the system uses semi-transparent bounding boxes of different colors to distinguish and render the lesion area on the original video screen according to the confidence level of the lesion.

[0015] As a further description of the above technical solution: the data synchronization service layer is configured with a de-identification engine on the cloud platform. The de-identification engine is used to sequentially perform de-identification, data generalization and data perturbation processing on the uploaded data. The processed and thoroughly de-identified data is imported into the scientific research database and input into the model training cluster to iteratively update the deep learning model.

[0016] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are: 1. The modular design of the reusable intelligent host and disposable sterile adapter allows the host to operate without direct contact with the patient, using only the disposable adapter. The adapter can be discarded after use, eliminating the risk of cross-infection at the source and greatly simplifying the postoperative cleaning and disinfection process.

[0017] 2. The main body of the device features a handheld and wireless design, completely eliminating the limitations of traditional carts and cables. It can be flexibly applied to various scenarios such as outpatient clinics, operating rooms, wards, and community screening. The system is equipped with examination and surgical adapters that support quick switching, ensuring seamless integration of diagnostic and minimally invasive treatment processes and fully meeting diverse clinical needs.

[0018] 3. The specially designed adapter structure allows it to be perfectly compatible with the disposable traditional anoscopes currently widely used in hospitals. The core imaging host is a durable component that can be reused for a long time. Users only need to replace the low-cost disposable adapter consumables, which significantly reduces the overall cost of ownership of the system and provides a practical solution for the promotion and popularization of advanced diagnostic and treatment technologies in primary healthcare institutions.

[0019] 4. The integrated artificial intelligence module can perform real-time analysis and indicate the location of lesions during the examination, providing important support for doctors to improve diagnostic accuracy. At the same time, it realizes a paperless operation throughout the entire process from image acquisition to AI automatic analysis, one-click generation of structured reports, and cloud data archiving, which significantly optimizes the standardization of medical record management and significantly improves the operational efficiency of clinical departments. Attached Figure Description

[0020] Figure 1 A schematic diagram showing the connection between the examination adapter and the anoscope of the present invention is shown; Figure 2 A schematic diagram showing the connection between the surgical adapter and the anoscope of the present invention is shown; Figure 3 A schematic diagram of the host computer of the present invention is shown; Figure 4 The present invention is shown. Figure 3 Another perspective view; Figure 5 An exploded view of the present invention is shown; Figure 6 A schematic diagram of the child-type adapter of the present invention is shown; Figure 7 The following is a block diagram of the mobile terminal application interface logic of the present invention; Figure 8 The flowcharts of the terminal layer, cloud platform layer, data storage layer, and application service layer of the present invention are shown. Figure 9 The flowchart of the intelligent assisted diagnosis and data processing method of the present invention is shown; Figure 10 The diagram illustrates the architecture of the cloud-based data processing and value mining system of this invention.

[0021] Legend: 10. Main unit; 11. Housing; 12. Male threaded block; 13. High-definition camera; 14. Ring fill light; 15. Snapshot switch; 16. Illumination and recording switch; 17. USB-C interface; 18. Status display screen; 19. Female threaded groove; 20. Inspection adapter; 21. Light guide structure; 22. Reinforcing plate; 23. Fixing ring; 24. Limiting baffle; 30. Anoscope; 31. Locking hole; 40. Surgical adapter; 41. Curved lens; 42. Straight lens; 43. Locking block; 44. Diagonal brace; 45. Column; 46. Fixing cylinder; 50. Child-friendly adapter; 51. Miniature light guide structure; 52. Widened limiting baffle. Detailed Implementation

[0022] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] Please see Figures 1-6 The present invention provides a technical solution: a handheld modular smart anoscope, including a disposable sterile adapter assembly that can be modularly connected to the host 10, and a mobile terminal, such as a tablet computer, that is wirelessly connected to the host 10.

[0024] The disposable sterile adapter assembly is compatible with existing standard disposable anoscopes 30, and the main unit 10 is a reusable handheld smart imaging device with a design that includes a grip-friendly housing 11.

[0025] The outer edge of the housing 11 is equipped with a male threaded block 12, which adopts a standard external thread screw interface to facilitate quick installation and removal of the adapter.

[0026] A high-definition camera 13 is integrated at the bottom front of the housing 11. It can be configured with a medical-grade miniature camera with 1080P or 4K resolution. The camera is surrounded by a ring light 14 composed of multiple LED beads. The ring design can provide a shadow-free, soft and uniform lighting effect, thereby ensuring that the inside of the cavity is clearly visible.

[0027] The top of the housing 11 is equipped with a snapshot switch 15 for easy operation; a lighting and recording switch 16 is provided on one side. Both support a combination of short press and long press functions. For example, a short press of the snapshot switch 15 can realize the rapid acquisition of images, while a long press can mark the current screen as a "suspected lesion point" and automatically transmit the marking information to the App so that it can be highlighted in subsequent reports.

[0028] In addition, to enhance convenience, one side of the housing 11 is equipped with a USB-C port 17, which can be used for fast charging of the device and wired data transmission, while the other side is equipped with a status display 18, which is recommended to be a high-quality OLED micro display screen to display information such as the device's battery level, wireless connection status and operating mode in real time.

[0029] The internal cavity of the main unit 10 also integrates a lithium battery, a control circuit board, a shooting and recording module, and a wireless communication module that supports Wi-Fi or Bluetooth. With the help of this wireless communication module, the main unit 10 can quickly transmit the high-definition images captured in real time to the mobile terminal, completely eliminating the dependence of traditional electronic anoscopes on connecting cables.

[0030] It is particularly important to emphasize that the overall shape and internal cavity design of the housing 11 are not limited by the traditional cylindrical shape. In order to provide sufficient internal space in the micro handheld device to reasonably accommodate precision components such as high-capacity lithium batteries, high-performance control circuit boards and wireless communication modules, while meeting the comfort requirements of doctors holding it with one hand, the cross-sectional shape of the housing 11 can be designed as an ellipse, a racetrack shape, a polygon with rounded corners, or an asymmetrical irregular structure that conforms to the curve of the palm. This cavity design that breaks away from the single cylindrical shape not only solves the spatial conflict problem of multiple components in high-density integration, but also greatly improves the anti-slip and anti-roll-off performance of the device during use.

[0031] Example 1: Routine Inspection Mode This embodiment describes in more detail the structural features and operation process of the examination adapter 20 in the disposable sterile adapter assembly. The examination adapter 20 includes a light guide structure 21 that can be embedded in the barrel of the anoscope 30, a reinforcing plate 22 connected to the inner cavity of the light guide structure 21, and a fixing ring 23 that is reliably fixed to the reinforcing plate 22.

[0032] The center of the retaining ring 23 is designed as a female threaded groove 19 with an internal thread, which is combined with... Figure 2 and Figure 5 It can be seen that the female threaded groove 19 is designed to precisely match the male threaded block 12 of the main unit 10, thereby achieving a firm screw connection between the two.

[0033] The light guide structure 21 is made of medical-grade PMMA (polymethyl methacrylate) material with excellent light transmission properties. Its appearance is designed to match the inner cavity of the anoscope 30, including but not limited to cylindrical, elliptical cylindrical or gradient cylindrical with a slight taper, to ensure seamless fit with anoscopes 30 of different cross-sectional shapes and efficient light guiding.

[0034] A limiting baffle 24 is provided at the top of the light guide structure 21. The limiting baffle 24 is an annular flange structure, which can stably fit the edge of the anoscope tube when the light guide structure 21 is smoothly inserted into the anoscope tube 30. The technical advantage of this design is that it can effectively fix the positional relationship between the host 10 and the anoscope 30, and avoid causing patient discomfort or visual field deviation due to the camera being inserted too deeply.

[0035] Inspection Operation Procedure Preparation: Open the sterilized packaging, take out the inspection adapter 20, and firmly screw the female threaded groove 19 of the retaining ring 23 onto the male threaded block 12 of the main unit 10; then, equip the main unit 10 with a disposable sterile protective cover and assemble the components into a complete inspection unit.

[0036] Insertion of anoscope: Guide the patient to adopt the lithotomy position or lateral decubitus position. After completing routine perianal disinfection, the operator slowly inserts the anoscope 30, which is coated with lubricant, into the patient's anal canal.

[0037] Connection and Imaging: Insert the light guide structure 21 of the examination adapter 20 connected to the host 10 into the barrel of the anoscope 30 in a straight line, and confirm that the limiting baffle 24 is firmly attached to the end of the barrel.

[0038] The operator holds the handle of the anoscope 30 with one hand, while gently placing their thumb on the top of the main unit 10 for operation, and then turns on the power to the main unit 10.

[0039] Examination process: Using the wireless connection function, the host 10 is paired with the mobile terminal and the dedicated APP is launched. After the lighting is turned on, the host 10 transmits high-definition images to the APP interface in real time. While the operator slowly pulls back the anoscope 30, he observes the anal canal and rectal wall. The AI-assisted diagnosis module built into the APP can automatically identify and mark suspected lesions.

[0040] Recording and Completion: During the inspection, images and videos can be captured easily by pressing buttons or using the APP function. After the inspection is completed, the APP can generate a structured electronic report with one click and supports cloud storage.

[0041] Finally, the used anoscope 30 and examination adapter 20 are safely disposed of as medical waste, and the main unit 10 is cleaned and disinfected before being put into use. The whole process ensures that the patient has "zero contact" with the equipment.

[0042] Example 2: Minimally Invasive Surgical Mode This embodiment details the structural design and operation method of the surgical adapter 40 in the disposable sterile adapter assembly. This adapter is designed for use in minimally invasive surgical procedures such as internal hemorrhoid ligation and injection.

[0043] The surgical adapter 40 includes a fixing part and an adjustable support part, which are used for mounting on the anoscope 30 and connecting to the main unit 10, respectively.

[0044] The fixing part includes an arc-shaped lens 41 that fits tightly against the inner wall of the scope tube and a straight lens 42 that fits against the handle. The shape of the arc-shaped lens 41 is precisely matched to the curvature of the inner wall of the disposable traditional anoscope, ensuring that it will not occupy extra cavity space after installation. The straight lens 42 is provided with a locking block 43 that matches the locking hole 31 of the handle of the anoscope 30 to achieve stable locking.

[0045] The adjustable support includes a diagonal brace 44 vertically connected to the straight-plate lens 42, and a fixing cylinder 46 connected to the diagonal brace 44 via a bent column 45 and fixedly mounted on the main unit 10; the fixing cylinder 46 has a female threaded groove 19 inside for connecting the main unit 10.

[0046] The column 45 is made of a flexible and shapeable metal gooseneck tube. Its design advantage is that doctors can flexibly change the direction of the camera by adjusting the bending angle of the column 45, thereby effectively avoiding instrument interference in complex surgeries.

[0047] Surgical auxiliary operation procedures Preparation and installation: First, firmly tighten the fixing sleeve 46 of the surgical adapter 40 to the main unit 10, and put a sterile protective cover on the main unit 10.

[0048] Subsequently, the curved lens 41 on the adapter is inserted into the anoscope 30 barrel that has been placed inside the anus, while the straight lens 42 is fixed to the handle and secured with the locking block 43.

[0049] Field of view adjustment: By adjusting the flexible column 45, the angle of the camera on the main unit 10 can be flexibly adjusted, and the main unit 10 can be rotated to achieve precise focus, thereby clearly presenting the surgical field of view.

[0050] Surgical Procedure: The adapter's semi-open design provides surgical instruments with a direct channel to the lesion. The surgeon can hold the anoscope 30 with one hand, view the magnified surgical image in real time via a mobile terminal, and simultaneously use the other hand to skillfully operate tools such as ligators and injection needles.

[0051] End stage: After the surgery is completed, the anoscope 30 and surgical adapter 40 are discarded; after cleaning the surface of the main unit 10, it can be used for the next surgery.

[0052] Example 3: Child Examination Mode This embodiment provides a child-friendly adapter 50 designed specifically for children. Considering that children's anorectal canals are narrower and their mucous membranes are more delicate, this child-friendly adapter is equipped with a miniaturized light guide structure 51. Its outer diameter is proportionally reduced to match the inner cavity of a child-specific anoscope, and the insertion end adopts a rounded chamfer design with a large curvature to minimize friction and discomfort during insertion.

[0053] Meanwhile, in order to deal with the possibility of non-cooperation or struggle by children during the examination, the widened limiting baffle 52 has been enlarged in radial dimension, which can effectively prevent the equipment from being excessively inserted into the intestine and ensure the absolute safety of the examination process.

[0054] The child-type adapter 50 also achieves seamless connection with the male threaded block 12 of the main unit 10 through the female threaded groove 19, ensuring the stability of optical transmission.

[0055] Example 4: Interface Logic of Mobile Terminal Applications The software and data management functions of this system mainly rely on the collaborative operation of a dedicated application (APP) on a mobile terminal (such as a tablet computer) and a cloud platform. Through wireless communication between the mobile terminal (such as a tablet computer) and the host 10, the system has successfully built a complete closed-loop process that integrates front-end interaction, real-time assisted diagnosis and back-end cloud collaboration.

[0056] See appendix Figure 6 This embodiment provides an application running on a mobile terminal, whose interface logic follows the doctor's clinical workflow from top to bottom, specifically divided into five levels: 1. User Login and Device Management Layer This level serves as the system's entry point. After the doctor completes account verification and login, the system uses Bluetooth (preferably Bluetooth Low Energy BLE 5.0) or Wi-Fi technology to search for and pair with the host 10. After successful pairing, the interface will display the device pairing status and battery level, and simultaneously retrieve the "patient queue" list for the day. The advantage of this technology is that it binds the identities of doctors, devices, and patients, providing a unique and reliable index basis for the automatic generation of subsequent electronic medical records.

[0057] 2. Real-time image acquisition and operation control layer: This level includes a high-definition video preview area, an image control area, and an auxiliary tool function area; Image control area: Provides virtual buttons such as "take photo", "record video" and "capture"; after the doctor clicks the "capture" button, the system will automatically obtain high-definition keyframes of the current video stream and store them in the local temporary storage space.

[0058] The auxiliary tool function area is equipped with operation sliders or buttons such as "brightness", "contrast", "annotation" and "zoom"; for example, when adjusting the "brightness" slider, the mobile device will send a PWM dimming command to the host 10, thereby changing the current duty cycle of the ring light 14 to better adapt to the environmental needs of different patients' intestinal cavities.

[0059] 3. Intelligent Assisted Diagnostic Layer (1) AI lesion real-time identification: The mobile terminal runs an optimized lightweight deep learning model (such as the optimized MobileNet or YOLO series convolutional neural network) in the background to directly perform frame-by-frame inference calculation on the received video frames; the model can identify abnormal tissues such as internal hemorrhoids, external hemorrhoids, anal fissures, and polyps in the video in real time, and generate the corresponding lesion classification label, location coordinates and confidence information; in order to ensure complete synchronization with the doctor's hand operation screen, the inference delay is preferably controlled within 100 milliseconds.

[0060] (2) Visual overlay of recognition results: The operating system will transparently overlay the recognition results of the aforementioned AI onto the original video screen in the form of "augmented reality" (AR).

[0061] The specific presentation format is as follows: If the confidence level of the lesion reaches or exceeds 80% (i.e., high confidence level), the system will render a red semi-transparent bounding box around the lesion. If the confidence level is between 50% and 80% (i.e., low confidence level), a yellow semi-transparent bounding box is rendered.

[0062] This color-separation display technology can clearly convey the credibility of AI's judgments without affecting the doctor's observation of the core field of vision, thereby achieving the early warning effect of immediate correction and prevention of missed diagnoses.

[0063] 4. Electronic Medical Record Reporting Layer (Automatic Generation of Electronic Medical Records) After the examination process is completed, the system will automatically jump to the electronic medical record editing interface. The background extracts the AI-recognized structured tags corresponding to the captured images (for example, extracting "Grade II internal hemorrhoids, lithotomy position 3 o'clock") and uses them as lower-level data to automatically fill the corresponding "examination findings" and "preliminary diagnosis" fields in the preset standardized structure report template.

[0064] Doctors only need to check or make minor adjustments, and finally export the report by clicking the "Generate PDF with one click" command. This closed-loop process greatly simplifies the operation and completely frees doctors from tedious manual document entry work.

[0065] 5. Data synchronization service layer: This layer ensures the efficient and secure flow of data between "local, cloud, and research terminals," and the specific implementation method is as follows: (1) Local encrypted storage mechanism After the video stream generated by the intelligent imaging host is transmitted to the mobile terminal, the system immediately generates a structured diagnostic report. The local encrypted storage module calls the random key provided by the hardware security module and uses advanced encryption standards (such as AES-256) to perform low-level encryption on the original image data and the PDF format electronic report.

[0066] The encrypted files are securely stored in the application's own sandbox directory, which is strictly physically isolated from the mobile device's public photo album and other third-party applications, fundamentally eliminating the possibility of unauthorized file copying or data leakage.

[0067] In addition, the system will build a lightweight encrypted index database locally to record case IDs, examination times, and the storage path of encrypted files, so that doctors can efficiently access historical medical records even in a network-free environment.

[0068] (2) Cloud-based secure backup and two-step synchronization The data synchronization service layer achieves a high degree of consistency between terminal data and the cloud platform through secure backup and synchronization modules. In response to the large size of medical video files, the synchronization module introduces segmented upload technology and supports breakpoint resume function.

[0069] During transmission, the system performs MD5 digest verification on each fragment to ensure the integrity and consistency of the cloud backup data. The module also has a two-way synchronization function. On the one hand, newly added examination records can be backed up to the cloud asynchronously in real time. On the other hand, when doctors log in to their accounts on different devices, the cloud will synchronize the index and summary information of historical examination records to the current device. The image files are encrypted and downloaded only when needed, thus achieving a balance between terminal storage space and usage efficiency.

[0070] (3) Integration of remote consultation and scientific research access The data synchronization service layer integrates remote consultation and scientific research interface modules. This module is the sole entry point for scientific research, teaching, and consultation activities. It operates based on a role-based access control mechanism, and access requests initiated by external experts or researchers must be verified through a dynamic token mechanism.

[0071] In remote consultation mode, the module extracts encrypted image files from the "original data security library" according to the consultation needs, and directly renders the image content using cloud streaming media forwarding technology, so that experts can achieve real-time collaborative diagnosis through the web or app without downloading the original data.

[0072] For research needs, this module also collaborates with a cloud-based data anonymization engine. When researchers initiate batch data extraction through this portal, the system automatically executes the anonymization process, exporting only anonymized structured feature data (such as lesion statistics and anonymized image sets), thereby protecting privacy while providing a standardized research data channel for epidemiological research and AI model training.

[0073] Example 4: Intelligent Assisted Diagnostic Method Based on Handheld Modular Intelligent Proctoscope System refer to Figure 7 and Figure 8 This embodiment details a method for intelligent auxiliary diagnosis of anorectal diseases based on the aforementioned handheld modular intelligent anorectal endoscope system. This method is executed via a mobile terminal or cloud-based software system, achieving intelligent processing from image acquisition to report generation. Specifically, it includes the following steps: Step S1: The intelligent imaging host 10 collects video stream data of the anorectal area in real time. The host 10 uses its built-in high-definition camera 13 to continuously output real-time images of the cavity under the physical isolation of the sterile adapter.

[0074] Step S2: Perform real-time frame sampling and preprocessing of the video stream data on a mobile terminal or in the cloud.

[0075] Step S3: Input the preprocessed image frame into the pre-trained lesion recognition model to obtain the recognition result including lesion type, location and confidence level.

[0076] Step S4: The recognition results are rendered in real time on the video display screen in the form of a visual overlay. For example, on the application interface of a mobile terminal, the lesion area can be displayed in augmented reality using semi-transparent bounding boxes of different colors according to the confidence level, so as to realize real-time auxiliary early warning.

[0077] Step S5: In response to the image capture command, acquire the target image containing the visualization overlay, and automatically populate the key information of the recognition result into the structured report template.

[0078] When a doctor operates the capture switch 13 on the host 10 or the virtual button on the mobile terminal, the system automatically extracts the current key frame and its corresponding lesion structure label (such as lesion type, location, etc.) and directly fills it into the diagnostic report template.

[0079] Step S6: Based on the doctor's confirmation of the report, an electronic diagnostic report is generated, and the target image, recognition results, and the report are linked and encrypted for storage. After the doctor reviews and modifies the report, the single examination process ends, and the doctor decides whether the data will be sent to the cloud for data processing and mining based on authorization.

[0080] Example 5: Closed-loop process for cloud-based data processing and value mining To break down medical data silos and protect patient privacy, combined with... Figure 8 This embodiment provides a data processing flow based on the above system.

[0081] After step S6 of Example 4 is completed, if the doctor authorizes the data upload, the following data processing stage will proceed: Step D1: After encrypting the electronic diagnostic report and related image data, synchronize them to the cloud data platform. The terminal's encrypted data packet is uploaded to the security proxy server through an API gateway with security authentication to achieve secure access to both internal and external networks.

[0082] Step D2: De-identify the received data in the cloud, remove personally identifiable information, and generate an anonymous research dataset; specifically, the uploaded data undergoes de-identification (such as replacing names and ID numbers with hash values) and data generalization (such as fuzzy checking of dates and age groups) in the cloud de-identification engine in sequence, severing personal identity links while retaining medical characteristics, and is then stored in an anonymous research database.

[0083] Step D3: Based on the anonymized research dataset, perform at least one of the following services: remote consultation, research statistical analysis, and iterative training of the lesion identification model.

[0084] The thoroughly anonymized data provides support for the scientific research analysis platform, while high-quality labeled data is input into the model training platform for iterative optimization of the AI ​​model. The new model version, after verification, can be distributed back to mobile terminals through the cloud, enabling the system to continuously evolve itself.

[0085] Example 6: Cloud Data Processing and Value Mining System Architecture and its Operating Logic refer to Figure 9 The encrypted data packets generated by the mobile terminal are first authenticated by the API gateway and protected by a two-way SSL encryption mechanism to ensure that they maintain a high degree of privacy in the public network.

[0086] Once authenticated, the traffic will enter the security proxy server, which will perform deep packet inspection (DPI) to build a physical and logical isolation barrier between the mobile terminal and the core business server, effectively preventing unauthorized intrusion.

[0087] After data enters the cloud platform, it must pass through a core de-identification engine to ensure compliance with medical data requirements; this engine consists of the following three modules: De-identification module: Uses a one-way hash algorithm (such as SHA-256) to replace direct identity identifiers such as patient name and ID number with irreversible hash labels to ensure privacy desensitization.

[0088] Data generalization module: performs fuzzing processing on sensitive attributes, such as simplifying specific outpatient times to "months" and converting patient ages into preset "age ranges".

[0089] Data perturbation module: Injects differential privacy noise conforming to the Laplace distribution into numerical features such as lesion size and confidence level, preventing reverse identification of individuals through multidimensional data cross-analysis, while ensuring the statistical analysis value of the data.

[0090] After data anonymization, the data will be placed in different storage and application scenarios according to business needs: Original Data Security Repository: This repository is dedicated to storing complete encrypted data containing access audit codes. It is only available to high-privilege users for medical tracing or judicial evidence preservation. All access records are preserved in an immutable manner using blockchain technology.

[0091] Research and AI Training Data Pool: Stores thoroughly anonymized structured images and diagnostic data to provide reliable data support for subsequent research and AI training.

[0092] In addition, experts can access case images in research databases through controlled access gateways to achieve cross-regional joint diagnosis and treatment online.

[0093] Researchers utilized the system's open API interface to conduct epidemiological analyses, disease distribution statistics, and efficacy studies on anonymized datasets. The system will also regularly select high-quality labeled images from the scientific research database and input them into the AI ​​training cluster for model updates and iterations.

[0094] After completing model retraining and accuracy verification, the update package is pushed to various mobile terminals via OTA technology, promoting the continuous upgrading of terminal AI recognition algorithms.

[0095] Working principle: It should be noted that the "modular" design mentioned in this application refers to the disassembly of the entire instrument into a high-value "reusable intelligent imaging host" and a low-cost "disposable sterile adapter" according to the characteristics of the physical structure. In addition, the "zero contact" concept mentioned in this application means that the host 10 is always placed inside a disposable sterile protective cover throughout the entire diagnosis and treatment process and is connected to the anoscope 30 only through the adapter. The host 10 itself completely avoids direct contact with the patient's body fluids or mucous membranes, fundamentally preventing the possibility of cross-infection.

[0096] In a routine outpatient examination scenario, the operator first connects the fixing ring 23 of the examination adapter 20 to the main unit 10; after the patient is placed in the lithotomy position, the operator inserts the anoscope 30, which has been coated with lubricant, into the patient's anal canal; then, the light guide structure 21 of the examination adapter 20 connected to the main unit 10 is embedded in the anoscope 30; the doctor holds the device with one hand, turns on the power, and views the internal wall image in real time through a mobile terminal APP, while simultaneously taking snapshots, and the AI ​​module is responsible for synchronously prompting possible lesions; after the examination, the anoscope 30 and the examination adapter 20 are disposed of as medical waste, while the main unit 10 only needs to be wiped clean for reuse.

[0097] In surgical settings, the examination adapter 20 is replaced with a surgical adapter 40, which is fixed to the handle of the anoscope 30 by a locking block 43. At the same time, the curved column 45 is used to adjust and prevent obstruction of the operating field of view. The doctor observes the magnified image on a tablet computer while holding a ligator or injection needle in the other hand. The doctor performs minimally invasive operations through the semi-open structure channel of the surgical adapter, thereby significantly improving the flexibility and accuracy of clinical operations.

[0098] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A handheld modular intelligent anoscope, characterized in that: Includes a main unit (10), an anoscope (30), and a disposable sterile adapter assembly that can be modularly connected to the main unit (10); The host (10) includes a housing (11), a male threaded block (12), a high-definition camera (13) and a ring fill light (14) disposed on the housing (11). The housing (11) is also equipped with a snapshot switch (15), a lighting and recording switch (16), a USB-C interface (17), and a status display screen (18). The disposable sterile adapter assembly includes an examination adapter (20), a surgical adapter (40), and a pediatric adapter (50) for selecting one of the adapters to connect to the male threaded block (12) of the host (10) under different diagnostic and treatment modes, and to cooperate with the anoscope (30) to form a physical isolation between the host (10) and the patient's body cavity.

2. The handheld modular intelligent anoscope according to claim 1, characterized in that: The inspection adapter (20) includes a light guide structure (21) and a limiting baffle (24) connected to the light guide structure (21). The light guide structure (21) is fixed with a fixing ring (23) by a reinforcing plate (22).

3. A handheld modular intelligent anoscope according to claim 2, characterized in that: The center of the fixing ring (23) is provided with a female thread groove (19) that seamlessly connects with the male thread block (12) of the host (10), and the light guide structure (21) is constructed to be able to be embedded in the barrel of the anoscope (30) in a straight line.

4. A handheld modular intelligent anoscope according to claim 3, characterized in that: When the light guide structure (21) is inserted, the limiting baffle (24) presses against the edge of the proximal end of the anoscope (30) tube.

5. A handheld modular intelligent anoscope according to claim 4, characterized in that: The surgical adapter (40) includes a fixing part and an adjustable support part; The fixing part includes an arc-shaped lens (41) that fits against the inner wall of the anoscope (30) barrel, a straight lens (42) that fits against the handle of the anoscope (30), and a locking block (43) provided on the straight lens (42) for fixing to the locking hole (31) of the handle. The adjustable support includes a diagonal brace (44) connected to the straight-plate lens (42) and a fixing cylinder (46) mounted on the diagonal brace (44) via a column (45). The fixed cylinder (46) is provided with a female thread groove (19) that is connected to the male thread block (12).

6. A handheld modular intelligent anoscope according to claim 2, characterized in that: The child-type adapter (50) includes a miniature light guide structure (51) and a widened limiting baffle (52) to prevent over-insertion. The outer diameter of the miniature light guide structure (51) is smaller than that of the light guide structure (21) of the inspection adapter (20). The widened limiting baffle (52) is fixedly connected to the miniature light guide structure (51).

7. An operating system, characterized in that, The device includes a handheld modular smart anoscope as described in claims 1-5, and also includes an application running on a mobile terminal and a cloud platform, wherein the operating system includes: User login and device management layer: used for account verification login, using wireless communication technology to pair and connect with the host (10), and display the power and status information corresponding to the status display screen (18) of the host (10) on the application interface, and synchronize the patient queue list; Real-time image acquisition and operation control layer: used to receive and display video stream data acquired by the high-definition camera (13); provide virtual buttons corresponding to the snapshot switch (15) and the lighting recording switch (16), and send dimming instructions to the host (10) to adjust the brightness of the ring fill light (14); Intelligent Assisted Diagnosis Layer: Utilizes a built-in deep learning model to perform real-time inference calculations on the received video frames, identify lesions and generate lesion classification labels and confidence information, and transparently overlay the identification results onto the original video screen in an augmented reality manner; Electronic medical record reporting layer: used to respond to the instructions of the capture switch (15) or the corresponding virtual button, extract the captured image and its corresponding lesion structured label, automatically fill it into the preset structured report template, and generate an electronic diagnostic report; Data synchronization service layer: used to upload encrypted electronic diagnostic reports and image data to the cloud platform via API gateway for classification, storage and data processing.

8. An operating system according to claim 7, characterized in that: In the intelligent auxiliary diagnosis layer, the system uses semi-transparent bounding boxes of different colors to distinguish and render the lesion area on the original video screen according to the confidence level of the lesion.

9. An operating system according to claim 7, characterized in that: The data synchronization service layer is configured with a de-identification engine on the cloud platform. The de-identification engine is used to perform de-identification, data generalization and data perturbation processing on the uploaded data in sequence. The processed and thoroughly de-identified data is imported into the scientific research database and input into the model training cluster to iteratively update the deep learning model.

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