Tympanic membrane puncture simulation device

Abstract

The present application relates to the technical field of medical teaching training equipment, and particularly relates to a tympanic membrane puncture simulation device and an otology simulation training system. The tympanic membrane puncture simulation device comprises a simulation cavity, a transparent membrane, an image display assembly, a lens assembly, a liquid simulation assembly and a membrane replacement assembly. The simulation cavity has an internal cavity and an opening on the front side. The transparent membrane covers the opening and cooperates with the simulation cavity to form a sealed cavity. The image display assembly is arranged behind the simulation cavity. The lens assembly is used for imaging the tympanic membrane anatomical structure and / or lesion image displayed by the image display assembly on the position of the transparent membrane or the clear observation area adjacent to the transparent membrane. The liquid simulation assembly comprises a liquid injection channel and an exhaust channel, which are used for injecting transparent liquid simulating middle ear effusion into the sealed cavity and discharging gas. The membrane replacement assembly comprises a pay-off shaft and a take-up shaft, which are used for replacing a new membrane segment after the transparent membrane is punctured. The device can realize simulation training of tympanic membrane observation, puncture positioning, liquid extraction and / or drug administration, and has the advantages of convenient repeated use, high training authenticity and strong teaching applicability.

Description

Technical Field

[0001] This invention relates to the field of medical simulation training technology, and in particular to a tympanic membrane puncture simulation device and an ear simulation training system for ear teaching and skills training. Background Technology

[0002] Tympanic membrane puncture is a common procedure in otolaryngology, frequently used for middle ear effusion drainage, pressure relief, drug administration, and as an adjunct treatment for related diseases. In actual clinical practice, the operator typically needs to first observe the tympanic membrane and its anatomical landmarks with an otoscope to identify the lesion area and the location of key structures before selecting an appropriate puncture point. Therefore, this procedure demands a high level of anatomical recognition ability, instrument handling skills, and accuracy in puncture localization.

[0003] Existing otology teaching and training devices mostly focus on tympanic membrane image observation or otoscopy training, primarily used to help trainees identify the appearance, pathological features, and anatomical structures of the external auditory canal. While these devices can meet basic observation teaching needs, they are generally insufficient to support further training in therapeutic procedures such as tympanic membrane puncture, fluid aspiration, or drug injection, and cannot fully simulate the continuous skill processes in clinical settings.

[0004] On the other hand, some existing puncture training models are often structurally simple, providing only a static membrane or cavity for puncture practice, lacking a design that integrates with tympanic membrane anatomy, lesion location, and fluid status. When trainees practice on such models, they cannot effectively establish a complete clinical operation logic of "observation-location-puncture-aspiration," resulting in limited training effectiveness. Furthermore, the membrane breaks down immediately after puncture, requiring frequent membrane replacements on conventional models, making reuse inconvenient and impacting teaching efficiency.

[0005] Meanwhile, during tympanic membrane puncture training, the presence of significant air bubbles within the cavity can easily affect the clarity of the observed images, reducing the simulation level of the training. Furthermore, if the process of fluid outflow or extraction after puncture cannot be simulated, it is difficult to accurately represent the realistic feel and feedback of procedures related to middle ear effusion. Therefore, providing a simulation device that can display the anatomical structure and lesion images of the tympanic membrane, perform puncture and fluid extraction training, and is easily reusable has become a technical problem that needs to be solved in this field. Summary of the Invention

[0006] The purpose of this invention is to provide a tympanic membrane puncture simulation device and an otology simulation training system to solve the problems of existing otology training devices, which can only be used for observation and teaching, are difficult to realize tympanic membrane puncture and fluid aspiration and drug administration training, have inconvenient membrane replacement, and lack simulation realism.

[0007] To achieve the above objectives, the present invention provides a tympanic membrane puncture simulation device, comprising a simulation cavity, a transparent membrane, an image display component, a lens component, a liquid simulation component, and a membrane replacement component.

[0008] The simulated cavity has an internal cavity and an opening located on the front side; The transparent membrane covers the opening and cooperates with the simulated cavity to form a sealed cavity. The transparent membrane is a transparent flexible membrane that can be punctured and broken. The image display component is located behind the simulated cavity and is used to display the anatomical structure of the tympanic membrane and / or lesion images; The lens assembly is disposed between the image display assembly and the simulated cavity, and is used to image the image displayed by the image display assembly onto the location of the transparent film or a clear observation area adjacent to the transparent film; The liquid simulation component includes an injection channel and an exhaust channel communicating with the simulation cavity, for injecting a transparent liquid simulating middle ear effusion into the sealed cavity and venting gas from the sealed cavity. The film replacement assembly includes an unwinding shaft and a rewinding shaft. The transparent film is disposed between the unwinding shaft and the rewinding shaft. By rotating the unwinding shaft and / or the rewinding shaft, the punctured and damaged film segment is moved away from the opening, and the unused film segment is moved to the opening to re-form a sealed structure. The operator can observe the image through an otoscope and puncture the transparent membrane to simulate fluid extraction and / or drug injection.

[0009] Furthermore, the membrane replacement assembly is configured to apply tension to the transparent membrane after the unused membrane segment moves to the opening, so that the transparent membrane adheres to the opening and remains sealed.

[0010] Furthermore, the exhaust channel is connected to a suction port, which is used to connect a syringe or suction device to extract residual air from the sealed cavity.

[0011] Furthermore, the simulated cavity is a transparent shell, which may be made of acrylic, polycarbonate or medical transparent polymer material.

[0012] Furthermore, the transparent membrane has a preset thickness and puncture resistance to simulate the resistance and rupture effect during tympanic membrane puncture.

[0013] Furthermore, the lens assembly is configured to establish a spatial correspondence between the anatomical landmark positions in the image and the target operating area on the transparent membrane, so that the operator can select the puncture point as observed in the image.

[0014] Furthermore, the image display component is a display screen, which is used to display images of different tympanic membrane pathological states. The images of different tympanic membrane pathological states include at least one or more of the following: tympanic membrane congestion images, secretory otitis media images, effusion images, and tympanic membrane perforation images.

[0015] Furthermore, the transparent liquid is water, saline solution, or a simulated liquid that matches the observation effect of middle ear effusion.

[0016] Furthermore, the device also includes a head mold or ear canal model, which forms an external auditory canal passage for insertion and observation by an otoscope, and the simulated cavity is disposed at the end of the external auditory canal passage.

[0017] The present invention also provides an otology simulation training system, including an otoscope simulation training module and the aforementioned tympanic membrane puncture simulation device. The otoscope simulation training module works in conjunction with the tympanic membrane puncture simulation device to achieve simulation training for tympanic membrane observation, lesion identification, puncture localization, and middle ear fluid extraction and / or drug administration.

[0018] Compared with the prior art, the present invention has at least the following beneficial effects: Achieve integrated training of observation and operation: Through the combination of image display component and lens component, the operator can identify the anatomical structure of the tympanic membrane and the location of lesions under otoscope observation conditions, and further complete the puncture operation, thereby achieving continuous training from observation to treatment operation.

[0019] By placing a transparent liquid inside the simulated cavity and covering the opening with a transparent membrane to form a closed cavity, the process of liquid outflow, extraction, or injection after puncture can be simulated, making the training feedback closer to clinical reality.

[0020] The membrane changing assembly, which includes an unwinding and rewinding shaft, allows for the rapid removal of damaged membrane segments and replacement with unused segments after the transparent membrane is punctured, reducing downtime and improving teaching and training efficiency.

[0021] By setting up injection and venting channels, gas can be expelled and air bubbles reduced during liquid injection, thus preventing air bubbles from interfering with image observation and puncture positioning.

[0022] The image display component can display images of different tympanic membrane pathological states, thereby supporting tympanic membrane recognition and puncture localization training in different case scenarios and enhancing the teaching coverage. Attached Figure Description

[0023] Figure 1 This is a schematic diagram of the overall structure of a tympanic membrane puncture simulation device according to the present invention.

[0024] Figure 2This is a schematic diagram of the structure of the simulated cavity, transparent membrane, and membrane replacement assembly in a tympanic membrane puncture simulation device of the present invention.

[0025] Figure 3 This is a schematic diagram of the imaging relationship between the image display component and the lens component in a tympanic membrane puncture simulation device of the present invention.

[0026] Figure 4 This is a schematic diagram showing the connection relationship of the liquid simulation component in a tympanic membrane puncture simulation device of the present invention.

[0027] Figure 5 This is a schematic diagram of the structure of a tympanic membrane puncture simulation device of the present invention, which is used in conjunction with a head model or ear canal model. Detailed Implementation

[0028] The present invention will be further described below with reference to embodiments. It should be understood that the following embodiments are only for explaining the present invention and are not intended to limit the scope of protection of the present invention. Without departing from the concept of the present invention, those skilled in the art can make adjustments or substitutions to the structural form, connection method, dimensional parameters and material selection.

[0029] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the following embodiments are only for explaining the present invention and are not intended to limit the scope of protection of the present invention. Without departing from the concept of the present invention, those skilled in the art can make equivalent substitutions or conventional modifications to its structural form, connection method, dimensional parameters, material selection, control method and local components, all of which should fall within the scope of protection of the present invention.

[0030] This invention is a tympanic membrane puncture simulation device and otological simulation training system, further developed from an otoscopy simulation training system, suitable for otological teaching and skills training. This solution aims to address problems in traditional otological training such as the scarcity of real case resources, limited training opportunities, the disconnect between theory and practice, the separation of observation and puncture training, inconvenient replacement of consumables, and insufficient training repeatability. Through the coordinated design of image display, optical imaging, fluid simulation, membrane replacement and repositioning, and ear canal space constraints, it enables tympanic membrane observation, lesion identification, puncture localization, fluid aspiration, simulated drug administration, and continuous repeatable training.

[0031] In some embodiments, the present invention can also be combined with an otoscope simulation training module and software system to form a complete training platform for realizing a continuous training process of theoretical learning, image recognition, otoscope observation, tympanic membrane puncture operation, and result evaluation. The hardware module is responsible for the optical processing, display, imaging, liquid simulation, and puncture support of the images, while the software system is responsible for image retrieval, image processing, parameter adjustment, interactive control, and training management. The two communicate with each other through a data interface.

[0032] The following preferred combinations Figures 1 to 5 The present invention will now be described.

[0033] like Figures 1 to 5 As shown, this embodiment provides a tympanic membrane puncture simulation device, including a simulation cavity 1, a transparent membrane 2, an image display component, a lens component, a liquid simulation component (in this example, the liquid space formed by the transparent membrane 2 and the opening can be filled with liquid through a liquid channel and vented through an exhaust channel), and a membrane replacement component 6. In some embodiments, a head model or ear canal model is also included; in further embodiments, a control module may be included, which can cooperate with an otoscope simulation training module and an external software system to form an otological simulation training system.

[0034] The simulated cavity 1 has an internal cavity and an opening on the front side. The simulated cavity 1 can be a hollow shell structure, and its shape can be elongated, box-shaped, columnar, near-drum-shaped, near-spherical crown-shaped, or other structural forms suitable for integration and installation. Preferably, the simulated cavity 1 is a transparent or semi-transparent shell to facilitate assembly, debugging, liquid observation, and internal state calibration. Its material can be acrylic, polycarbonate, transparent resin, ABS composite transparent components, or other medical transparent polymer materials.

[0035] The transparent membrane 2 covers the opening and cooperates with the simulated cavity 1 to form a sealed cavity. The transparent membrane 2 is a puncture-resistant, flexible membrane, and its material can be polyethylene film, polyurethane film, silicone film, transparent elastic polymer film, or other membrane materials capable of achieving a puncture and rupture effect and forming a liquid seal. The transparent membrane 2 has a preset thickness and puncture resistance to simulate the resistance and rupture effect during tympanic membrane puncture. Its thickness, flexibility, tension, and rupture pattern can be adjusted according to the training subject, the equipment used, and the difficulty of the simulation.

[0036] The image display component is located behind the simulated cavity 1 and is used to display images of the anatomical structure of the tympanic membrane and / or images of lesions. The displayed content may include images of a normal tympanic membrane, images of tympanic membrane hyperemia, images of tympanic membrane retraction, images of tympanic membrane bulging, images of secretory otitis media, images of effusion, images of tympanic membrane perforation, images of calcifications, and other pathological images suitable for otological teaching and training.

[0037] The lens assembly is disposed between the image display assembly and the simulation cavity 1, and is used to image the image displayed by the image display assembly onto a clear observation area at or near the location of the transparent membrane 2. Through optical scaling, aberration control, and position calibration of the lens assembly, a stable spatial correspondence can be established between the tympanic membrane anatomical landmarks in the displayed image and the target operating area on the transparent membrane 2, thereby enabling the operator to locate and perform puncture operations on the transparent membrane 2 based on the image when observing with an otoscope.

[0038] The liquid simulation component includes an injection channel 51 and an exhaust channel 52 communicating with the simulation cavity. These are used to inject simulated liquid into the sealed cavity formed by the simulation cavity 1 and the transparent membrane 2, and to expel gas from the cavity, thus simulating a middle ear effusion environment or other liquid conditions. Through the liquid simulation component 5, training effects such as liquid outflow, liquid aspiration, and liquid injection can be achieved after the transparent membrane 2 is punctured.

[0039] The membrane replacement assembly 6 includes an unwinding shaft 61 and a rewinding shaft 62 (the rewinding shaft 61 and rewinding shaft 62 are rotated by their respective gears 611 and 612. This is just one example). The transparent membrane 2 is disposed between the unwinding shaft 61 and the rewinding shaft 62 and spans across the opening 12. When the current membrane segment is punctured and damaged, the damaged membrane segment can be moved away from the opening by rotating the unwinding shaft 61 and / or the rewinding shaft 62, and a new, unused membrane segment can be moved to the opening 12 to re-form a sealed cavity for use in the next round of training.

[0040] During training, the operator can use an otoscope to observe the imaging area corresponding to the transparent membrane 2 from the front of the device or through an ear canal model, and determine the puncture point based on the displayed tympanic membrane structure and lesion location. The transparent membrane 2 is then punctured to perform fluid aspiration and / or simulated drug administration training. After training, the membrane segment can be quickly replaced and reused via the membrane replacement assembly 6.

[0041] To ensure a stable seal after the transparent film 2 covers the opening, in this embodiment, an annular bonding surface is provided around the periphery of the opening. When the transparent film 2 is located at the opening, it adheres to the annular bonding surface, thereby forming a circumferential seal of the sealed cavity.

[0042] The annular bonding surface can be integrally formed from the front side of the simulated cavity 1, or it can be an independently set annular support boundary around the opening. Its cross-section can be planar, micro-protrusion, stepped, or a bonding form with a shallow groove structure. Preferably, the annular bonding surface has a high degree of surface flatness to reduce the problems of wrinkles, local suspensions, or uneven sealing of the transparent film 2 during the bonding process.

[0043] In some embodiments, a soft sealing layer, such as a silicone layer, an elastic sealing ring, a thin elastic pad, or a medical flexible covering layer, may be provided on the annular bonding surface to improve sealing stability and accommodate variations in the thickness of the transparent film 2. In other embodiments, the annular bonding surface may be configured as an annular flange slightly higher than the front surface of the simulated cavity to create higher local bonding pressure during subsequent film pressing.

[0044] By setting an annular bonding surface, the transparent film 2 can form a stable seal without the need for a one-time adhesive method after replacement, thus taking into account repetitive training, convenient disassembly and assembly, and efficient film replacement.

[0045] To ensure a reliable seal at the opening and prevent displacement during training, the membrane replacement assembly 6 in this embodiment further includes a pressing structure. The pressing structure is located around the opening and is used to press the transparent membrane 2 located at the opening 2 firmly onto the annular bonding surface.

[0046] The pressure membrane structure can be fixed, flip-up, sliding, snap-on, magnetic, hinged, or detachable. Preferably, the pressure membrane structure acts on the peripheral area of ​​the transparent membrane 2, while reserving observation and puncture space in the central area of ​​the opening, so as to avoid obstructing the otoscope's field of vision or interfering with the operation of the puncture instrument.

[0047] In practical applications, after the new membrane segment moves to the opening position via the membrane replacement assembly 6, the pressure membrane structure presses the transparent membrane 2 backward against the annular bonding surface, thereby forming circumferential pressure. This structure improves the liquid retention capacity, reduces the risk of cavity leakage, and maintains the transparent membrane 2 in a relatively stable tension state to more realistically simulate the tactile feedback during tympanic membrane puncture.

[0048] In a preferred embodiment, the pressure film structure is a pressure frame. The middle of the pressure frame has an observation window corresponding to the opening, the window area of ​​which is not smaller than the observation area required for training. The pressure frame can be fixed to the front side of the simulation cavity 1 by screw connection, snap-fit ​​connection, plug-in connection, magnetic connection, or twist-lock connection. After the pressure frame is installed, its rear edge presses the transparent film 2 against the annular bonding surface, thereby achieving stable pressure.

[0049] In another embodiment, the pressure film structure is an elastic pressure ring. The elastic pressure ring can be a silicone ring, a thermoplastic elastomer ring, a metal elastic ring with rubber coating, or other annular components with radial preload capability. After assembly, the elastic pressure ring uses its own elasticity to apply a clamping force toward the annular bonding surface of the transparent film 2.

[0050] In another embodiment, the pressure membrane structure is a pressure holding member detachably connected to the simulation cavity 1. The pressure holding member may be a number of segmented pressure blocks, distributed circumferentially along the opening, and installed on the front side of the simulation cavity 1 by screws, pins, slots, or buckles. This method facilitates local maintenance, local replacement, and adjustment of the pressure in different areas.

[0051] Regardless of the form used, the pressure membrane structure preferably applies a pressing force toward the annular bonding surface to the transparent membrane 2 after the transparent membrane 2 has moved to the opening, in order to improve sealing stability, keep the membrane surface flat and reduce membrane slippage during puncture.

[0052] The device also includes at least one imaging lens, which is arranged along the optical path from the image display component to the opening. By adjusting the distance between the imaging lens and the image display component 3 and / or the distance between the imaging lens and the opening, the target anatomical region in the image can be imaged at the location of the transparent membrane 2 or its adjacent area.

[0053] In one important embodiment of the present invention, the lens assembly is used to realize a composite optical path design of screen image reduction and otoscope observation magnification, so that the trainee can obtain a visual size and clinical observation experience similar to that of a real tympanic membrane when observing through an otoscope. Its basic optical path may include: the image display component 3 emits image light, which is processed by the lens assembly to form a reduced virtual image or an adapted intermediate image, which is then magnified and observed through an external otoscope, and finally received by the human eye.

[0054] To enhance the realism of the simulation, the reduction factor of the lens assembly can be matched with the inherent magnification of the otoscope. For example, in some embodiments, the image reduction ratio formed by the lens assembly is K, and the inherent magnification of the otoscope is M, preferably satisfying K×M approximately equal to 1, or ensuring that the visual size of the image observed by the trainee through the otoscope matches that observed when viewing a real tympanic membrane.

[0055] In one specific implementation, the lens assembly includes at least a first concave lens and a second concave lens arranged sequentially along the optical path. By configuring the focal length, refractive index, curvature, and air gap between the first and second concave lenses, the image displayed on the miniature display screen is formed into a reduced virtual image located at a preset observation position after passing through the lens assembly 4. The preset observation position can simulate the visual relationship between the end of the external auditory canal and the tympanic membrane, thereby enabling the otoscope to obtain a more realistic observation effect when approaching the clinical working distance.

[0056] In a further embodiment, the lens assembly may also include a three-layer concave lens group for performing multiple optical reduction processes on the image and further correcting spherical aberration, chromatic aberration, field curvature, and geometric distortion. Preferably, the optical axis of the multi-layer concave lens is aligned with the display center of the image display assembly 3 and the observation axis of the otoscope to improve the full field of view sharpness and image position stability.

[0057] For this invention, the optical core of the entire system's simulation of realism lies in reducing the image displayed by the image display component to a scale that matches the actual size of the tympanic membrane. This process is not simply about arranging several concave lenses, but rather about configuring parameters and optimizing their positions based on optical imaging principles. By adjusting the lens focal length, lens spacing, refractive index, and optical axis position, a larger image on the image display component can be transformed into a smaller virtual image located at a preset position, and this virtual image, when observed through an otoscope, will match the visual size of the actual tympanic membrane.

[0058] To facilitate the installation, positioning, and calibration of the lens assembly, in this embodiment, the lens assembly is provided with a lens mounting base 42. The lens mounting base 42 is adjustable relative to the simulation cavity and / or the image display component to calibrate the axial position and optical axis alignment of the lens assembly 4.

[0059] In this embodiment, the lens mounting base 42 can be disposed in the support body. The support body may include an upper support and a lower support, wherein the lower support may sequentially form a plurality of fixing units for fixing the image display component, the field lens layer and each lens unit respectively; the upper support may serve as a cover plate to protect and shield the lower components. The fixing unit may be a fixing groove, a lens seat, a slot, a holding hole or a bearing structure with positioning edges.

[0060] For example, the lower support portion can be sequentially arranged with a first fixing unit, a second fixing unit, a third fixing unit, and a fourth fixing unit along the optical path direction. The first fixing unit is used to install the micro-display 221, and the second to fourth fixing units are used to install different lenses in the lens group. The spacing between each fixing unit can be determined according to optical design calculations to meet the requirements of progressive image reduction and aberration correction.

[0061] By setting up the lens mounting base 42 and the corresponding support structure, it can be ensured that after each lens is installed, its optical center basically coincides with the center of the miniature display screen, and that the observation path of the otoscope and the image imaging path maintain a high degree of coaxiality. This is beneficial for obtaining clear images and for maintaining the correspondence between anatomical landmarks in the image and the puncture area on the transparent membrane 2.

[0062] In a preferred embodiment, the lens mounting base 42 is provided with at least one of a threaded adjustment structure, a sliding groove adjustment structure, or a shim adjustment structure, for changing the relative position between the lens assembly and the image display assembly 3 to obtain a clear image of the transparent film 2 area.

[0063] The threaded adjustment structure may include an adjustment ring, a threaded sleeve, a threaded column, or a fine-tuning screw, which allows the lens assembly to move axially back and forth by rotation for fine focusing.

[0064] The slide adjustment structure may include a guide groove arranged along the optical axis or laterally. The lens mounting base 42 can move along the guide groove after the locking member is released, and then be fixed after adjustment.

[0065] The shim adjustment structure allows for fine-tuning of the position of the lens assembly 4 by setting shims of different thicknesses between the lens mount and the substrate, thereby compensating for assembly tolerances.

[0066] In one specific embodiment, coarse adjustment can be achieved first using a sliding groove structure, followed by fine adjustment using a threaded adjusting ring, and finally, local deviations can be corrected using shims to ensure that the back-focus relationship between the image display component 3 and the lens component 4 meets the design requirements. If necessary, the screen-first lens spacing can also be specifically calibrated to position the display screen at the object plane position designed for the lens group, thereby obtaining the clearest virtual image.

[0067] In a further embodiment, the first concave lens and / or the second concave lens may also employ an aspherical design to correct spherical aberration and distortion, thereby improving overall sharpness and shape fidelity.

[0068] like Figure 4 As shown, the liquid simulation component 5 includes an injection channel 51 and an exhaust channel 52 communicating with the simulation chamber 1. Preferably, the injection channel 51 is located at the lower part or lower side of the simulation chamber 1, and the exhaust channel 52 is located at the upper part or upper side of the simulation chamber 1, so that the gas in the chamber is discharged from the upper part during the injection process, thereby reducing the residual air bubbles.

[0069] The simulated liquid can be water, saline, physiological saline, glycerol aqueous solution, transparent simulated liquid, or other liquids that match the observation effect of middle ear effusion. By injecting an appropriate amount of simulated liquid into the closed cavity, the middle ear effusion environment can be simulated, so that after the transparent membrane 2 is punctured, liquid can flow out, can be aspirated, or can be injected to achieve the training effect.

[0070] By placing the injection channel 51 at a low position and the venting channel 52 at a high position, the natural law of liquid filling from low to high and air venting from high to low can be utilized, reducing the problem of air bubbles being formed by liquid entrainment. Compared with a scheme where the injection port and venting port are at the same horizontal position, this high-low arrangement is more conducive to improving image clarity and liquid stability.

[0071] In some embodiments, the injection channel 51 and the venting channel 52 may be respectively provided with an on / off valve, a one-way valve, a sealing plug, or a hose clamping structure to facilitate control of liquid inflow and outflow and to prevent leakage.

[0072] To further reduce the impact of air bubbles on imaging effects and training simulation accuracy, the exhaust channel 52 is connected to a suction port, which is used to connect a syringe or suction device to suction and exhaust the sealed cavity after liquid injection is completed.

[0073] The aspiration port can be a Luer connector, a conical head, a hose connector, or a valve-equipped connector. After injection, the operator can connect the syringe to the aspiration port to remove residual air bubbles at the top or in certain areas of the cavity, thereby further improving the uniformity of the liquid environment behind the transparent membrane 2 and the image clarity.

[0074] In some implementations, a one-way valve may be provided at the suction port to prevent outside air from re-entering the sealed cavity after suction is completed.

[0075] In other embodiments, a buffer section or transparent connecting hose may be provided between the suction port and the exhaust channel to allow observation of the exhaust situation and liquid position.

[0076] In this embodiment, the injection channel 51 is provided with an injection interface, which is used to connect a syringe, a reservoir or an infusion line to inject the simulated liquid into the sealed cavity in a quantitative manner.

[0077] The injection port can adopt a standard medical connector, which is convenient for connection with common syringes, infusion sets, reservoir bags or micro-pumps. The operator can inject different volumes of simulated liquid into the simulated cavity 1 according to the teaching objectives, thereby creating different liquid levels, different degrees of tympanic membrane bulging or different pathological states.

[0078] For example, a graduated syringe can be used to inject a predetermined number of milliliters of liquid into a closed cavity so that different trainees can train under the same liquid conditions, thereby improving the consistency of assessments and the standardization of repetitive training.

[0079] In some implementations, the viscosity, transparency, or refractive properties of the simulated liquid can be adjusted to simulate different pathological fluid states, but it is preferred to use a liquid system that is safe for the device and easy to clean.

[0080] like Figure 2 As shown, the membrane replacement assembly 6 includes an unwinding shaft 61 and a take-up shaft 62. The transparent membrane 2 is disposed between the unwinding shaft 61 and the take-up shaft 62, and spans the opening at the front of the simulated cavity 1. When the current membrane segment is punctured and damaged, the punctured membrane segment can be moved away from the opening 12 by rotating the unwinding shaft 61 and / or the take-up shaft 62, and the unused membrane segment can be moved to the opening to re-form a sealed structure.

[0081] To ensure that the new membrane segment remains flat and taut after moving to the opening, in a preferred embodiment, the membrane changing assembly 6 further includes a tensioning structure. The tensioning knot 4 is disposed on at least one of the unwinding shaft 61 and the rewinding shaft 62, and / or disposed on the transport path of the transparent membrane 2, for applying tension to the transparent membrane 2 spanning the opening to keep the membrane surface flat.

[0082] The tensioning structure can be located at the end of the roll shaft, at the guide wheel, at the pressure wheel, at the membrane edge limiting structure, or in an independent tensioning wheel mechanism. Its function is to prevent the transparent membrane 2 from wrinkling, loosening, partially hanging, or lifting at the edge at the opening, so as to ensure the stability of observation effect, sealing effect, and puncture feel.

[0083] In some embodiments, the unwinding shaft 61 and the rewinding shaft 62 can be driven manually, such as by a knob, dial, crank, or turntable; or electrically, such as by a geared motor, stepper motor, or servo drive. For teaching and training equipment, manual drive structures typically have the advantages of being easy to manufacture, having low maintenance costs, and being highly intuitive.

[0084] In a preferred embodiment, the tensioning structure is one or more of a spring preload mechanism, a friction damping mechanism, or a one-way locking mechanism.

[0085] The spring pretensioning mechanism can be provided with a torsion spring, coil spring or tension spring on the unwinding shaft 61 or the take-up shaft 62 so that the shaft always provides a preset tension to the transparent film 2.

[0086] The friction damping mechanism can be equipped with friction washers, damping plates, adjustable damping caps or torsion limiting structures at the end of the roll to prevent the transparent film 2 from loosening due to inertia after film replacement.

[0087] The one-way locking mechanism can be a ratchet pawl, a backstop gear, a one-way clutch, or a one-way friction component, which restricts the reverse retraction of the transparent membrane 2 after it moves to the opening.

[0088] Preferably, the one-way locking mechanism restricts the reverse retraction of the transparent membrane 2 after the new membrane segment is in place, so as to avoid membrane position drift caused by otoscope contact, puncture disturbance, and changes in liquid pressure during training. This can improve the consistency of the target area position and the stability of membrane tension during each training session.

[0089] In some implementations, the transparent film 2 can be moved a fixed length each time by setting the angle of rotation of the winding shaft 62, so that the new film segment can accurately cover the opening.

[0090] like Figure 5 As shown, in some embodiments, the tympanic membrane puncture simulation device further includes a head mold or ear canal model. The head mold or ear canal model forms an external auditory canal passage for otoscope insertion and observation, and the simulation cavity 1 is disposed at the end of the external auditory canal passage, with the opening facing the external auditory canal passage.

[0091] The head model can be a simulation model of a partial structure of the human head or the shape of the human ear region, while the ear canal model can be a simplified training structure that only retains the external auditory canal passage. Materials used can include plastic, silicone, resin, elastic polymer materials, or composite molding materials.

[0092] In a preferred embodiment, the head shell is integrally molded from medical-grade silicone material, and its external dimensions are designed with reference to the physiological parameters of an adult human head. An installation chamber is reserved inside the head shell to fix and support the main body and the core structure of the tympanic membrane puncture simulation device. The position of this installation chamber corresponds to the anatomical position of the human ear to ensure that the central axis of the image display component, lens component, and simulation cavity 1 is substantially aligned with the central direction of the external auditory canal, thereby ensuring the accuracy of the observation angle.

[0093] By setting up head models or ear canal models, operators need to insert an otoscope through the ear canal for observation according to clinical routines during training, and complete the positioning and operation of puncture instruments within a limited space, thereby improving the consistency between the training process and the real clinical situation.

[0094] In a preferred embodiment, at least one of the length, diameter, curvature, and tilt angle of the external auditory canal passage is set according to the anatomical parameters of the human external auditory canal to constrain the insertion path and observation angle of the otoscope.

[0095] For example, the external auditory canal access can simulate the effective length and internal diameter variations of the adult ear canal, with appropriate curvature, so that the otoscope needs to be adjusted in direction and depth during insertion before the entire tympanic membrane area can be seen. This setup helps trainees develop spatial awareness, operational angle awareness, and observational focusing habits consistent with clinical practice.

[0096] In different implementations, the external auditory canal access can also be designed differently for different clinical scenarios such as adults, children, left ear, and right ear. For example, the pediatric version can shorten the access length and reduce the aperture, and the left and right ears can be set with opposite tilt directions to meet different training needs.

[0097] The presence of the external auditory canal not only provides shape simulation, but more importantly, through its length, curvature, and angle settings, it creates spatial constraints on the insertion path of the otoscope and the line of sight during operation, thereby enhancing the realism of the training.

[0098] In this embodiment, the device further includes a control module connected to the image display component and configured to control the image display component to switch between displaying different tympanic membrane anatomical structure images and / or lesion images.

[0099] The control module may consist only of the display screen's built-in driver board, or it may further include a main control chip, an image buffer unit, a display driver circuit, a communication interface, and a data interface for connecting to external software systems. The main control chip can be a microcontroller, an embedded processor, or other circuit modules capable of display control, such as an STM32 series controller. The control module can connect to external devices via UART, USB, HDMI conversion links, MIPI-related interfaces, or other communication methods.

[0100] In addition to controlling image switching, the control module can also adjust the display area and / or display ratio of the output image according to the imaging parameters of the lens assembly 4 and the location of the transparent membrane 2, so that the target area observed through the otoscope corresponds to the puncture operation area on the transparent membrane 2. Specifically, this may include cropping the tympanic membrane image display area; scaling the entire image; adjusting the image center position so that the tympanic membrane umbilicus, malleus handle, or target quadrant falls within the predetermined observation area; calling different display parameter groups according to different lens assembly 4 parameters; and calling different field-of-view adaptation parameters according to different head models or ear canal models 7.

[0101] In a further embodiment, the control module can also be used for image processing in the otoscopy simulation training system. After acquiring the original medical image, the control module performs image preprocessing on the original medical image to compensate for the imaging deviation of the optical system, and then outputs the processed image to the image display component for observation. The image preprocessing may include at least one of the following: resolution matching processing; optical distortion pre-compensation; edge enhancement processing; sub-pixel rendering optimization; gamma correction adjustment; and brightness uniformity correction.

[0102] A preferred process may include the following steps: First, perform resolution matching optimization. First, the native resolution parameters of the image display component are obtained, and the original image retrieved from the clinical case database is compared with the native resolution. If the original image resolution is inconsistent with the native resolution, an interpolation algorithm is used for scaling, preferably the Lanczos interpolation algorithm, to preserve image edge details and texture information and reduce scaling jagged edges and distortion.

[0103] Next, optical distortion pre-compensation is performed. Based on the system's preset optical parameters, such as lens curvature, lens spacing, magnification, and otoscope magnification coefficient, the image is subjected to reverse distortion correction to offset the geometric deformation caused by the lens group and otoscope link, so that the final observed image is closer to the real anatomical proportions of the tympanic membrane.

[0104] Then, edge enhancement processing is performed. An unsharpened mask algorithm is used to enhance the edges of the image, thereby improving the discernibility of pathological features such as perforation edges, congested areas, calcifications, and effusion contours. In one example, a parameter combination with a radius of approximately 1.0 and an intensity of approximately 0.3 can be set.

[0105] Perform subpixel rendering optimization again. For the pixel arrangement of the screen in the image display component, such as RGB vertical stripe arrangement, delta arrangement or other sub-pixel structure, sub-pixel rendering technology is used to improve the visual resolution and detail of the image and reduce the loss of detail in the scaling-up link.

[0106] Gamma correction adjustment was then performed. Considering that the lens assembly and otoscope observation link can cause image contrast attenuation, gamma correction can be applied to the image to enhance details in dark areas and control overexposure in bright areas. In one example, the gamma value can be set to approximately 0.45, which improves the visibility of deep middle ear structures, the shadow area at the edge of the tympanic membrane, and lesion details through nonlinear brightness mapping, making the training observation effect closer to the clinical reality.

[0107] Finally, brightness uniformity correction is performed. To address the potential vignetting effect in lens systems, where the brightness at the image edges is lower than that in the central area, brightness compensation can be applied to the image edge areas based on a pre-defined vignetting distribution model. This ensures a more uniform brightness distribution across the entire tympanic membrane observation area, preventing lesion identification and operational judgment from being affected by darkened edges.

[0108] The image processed as described above is transmitted to the image display component for display. After further processing by the lens component 4 and the otoscope observation link, the final imaging effect is achieved with reduced pixelation, clear details, discernible lesion features, and an observation scale close to the real clinical state.

[0109] In this embodiment, the image display component is preferably a micro-display module, which may include a micro-display screen, a controller, and a driving circuit. The micro-display module can be installed as a whole within the support body and arranged sequentially with the lens assembly along the optical axis.

[0110] The microdisplay can be an OLED microdisplay, an LCD microdisplay, a Micro OLED display, or other display devices suitable for near-eye imaging and miniaturized integration. Preferably, the microdisplay has a high pixel density to reduce pixelation when viewed through an otoscope. For example, a microdisplay between 0.5 inches and 2 inches can be used, with a resolution of 720p, 1080p, 1920×1200, 2560×1440, or other specifications that meet imaging accuracy requirements.

[0111] In some preferred embodiments, high-resolution microdisplays for industrial or embedded applications can be selected, such as display units ranging from 0.7 inches to 1.03 inches, to balance image detail, size integration, and drive adaptability. For high-resolution screens, even under subsequent magnified observation with an otoscope, the pixel structure may still be visible due to the magnified pixel pitch. Therefore, this invention further reduces pixelation through lens path reduction, diffusion layer, and image processing algorithms.

[0112] The controller can be a microcontroller, an embedded control chip, or a display driver board. The controller receives image loading, brightness adjustment, contrast adjustment, and mode switching commands from software systems or external devices via a communication interface, and controls the micro-display to display the corresponding images. The controller can also have a built-in image cache module to pre-store commonly used tympanic membrane disease images, improving image switching and loading efficiency.

[0113] The driving circuit may include a power conversion module and a display driving module. For example, an external input voltage can be converted into the operating voltage required by the display screen through a DC-DC module, and overvoltage and overcurrent protection structures can be set to ensure stable system operation.

[0114] In some implementations, the PCB board of the micro-display module may also be equipped with an HDMI interface, a USB interface, a UART interface, a MIPI interface, or other commonly used interfaces. The HDMI interface can be used to connect to an external display device, allowing teachers to demonstrate synchronously during instruction; the USB interface can be used for power supply and data exchange; the UART interface can be used for communication with the main control module; and the MIPI interface can be used for high-speed image signal transmission.

[0115] In a preferred embodiment, the lens assembly 4 may include a microstructured diffusion film, a field lens layer, a multilayer concave lens group, and an exit window layer arranged sequentially from the display screen side to the observation side. This structure can serve as a relay lens system to achieve a combined effect of image reduction, aberration correction, and pixel attenuation.

[0116] To further reduce the visibility of pixels on the microdisplay after magnification by an otoscope, in some embodiments, a microstructure diffusion film can be formed on the surface of the microdisplay 221. The microstructure diffusion film may include one or more of a frosted film, a microlens array film, and a photolithographic diffusion film, and the diffusion angle is preferably 5 to 15 degrees, for example, about 10 degrees.

[0117] After the microstructure diffusion film is applied to the surface of the display screen, it can moderately diffuse the light emitted by individual pixels, break up the pixel boundaries, improve the sense of image continuity, and thus reduce the pixel graininess in the overall optical path of "first shrinking and then enlarging".

[0118] In some embodiments, a field lens layer may be disposed between the microstructure diffusion film and the first concave lens. This field lens layer is preferably a concave lens structure positioned close to the microdisplay to collect light rays at larger angles, improve light utilization, and enhance brightness in edge regions. The field lens layer may be made of a high refractive index material, such as optical glass with a refractive index Nd greater than 1.7.

[0119] The multi-layer concave lens group may include two or three layers of concave lenses. Preferably, a three-layer concave lens structure is used to sequentially complete initial reduction, further reduction, and aberration correction. The focal length of each lens can be configured according to optical design requirements. For example, the first layer of concave lenses undertakes the main divergence and reduction functions, the second layer is used for further reduction and correction of spherical aberration, and the third layer is used to complete the final reduction and improve chromatic aberration or edge sharpness.

[0120] The lens material can be K9 glass, H-K9L optical glass, high-refractive-index glass, optical-grade plastic, or other materials suitable for precision imaging. Preferably, the lens surface is treated with a broadband anti-reflection coating to improve transmittance and reduce stray reflections.

[0121] In some embodiments, an exit window layer may be provided on the observation side of the lens assembly. The exit window layer may be a plano-concave lens structure, with its planar side facing the otoscope and its concave side facing the lens assembly. The curvature of the exit window layer can be optimized according to the working distance and observation path of commonly used otoscopes to improve the imaging clarity and field of view adaptability after the otoscope is connected.

[0122] The lens assembly is preferably designed so that the optical axes of the miniature display 221, the field lens layer, the multi-layer concave lenses, and the exit window layer are substantially coincident, and the distance between the screen and the lens group satisfies the back focus alignment relationship. This enables the formation of a relatively clear reduced image at the target observation position and provides a good intermediate imaging basis for further magnified observation with an otoscope.

[0123] In this embodiment, a support body 210 may be provided to facilitate stable installation of the image display assembly and the lens assembly. The support body 210 may include an upper support 210a and a lower support 210b, which may be connected by snap-fit ​​connection, screw connection, plug-in connection or other detachable methods.

[0124] The lower support portion 210b can be configured as a support member with a receiving groove, and a plurality of fixing units 211, 212, 213, etc. are sequentially arranged along the optical path direction. Among them, the first fixing unit 211 is used to install the micro display screen 221, and the second fixing unit 212, the third fixing unit 213, etc. are used to install the lens units or emitting components in the lens assembly. The fixing unit can be a groove structure, a circular slot structure, an annular lens seat, or other structures suitable for positioning the lens.

[0125] In one specific embodiment, the lower support portion 210b can be in the form of a rectangular groove structure, the bottom shape of which is adapted to the outer contour of the micro-display module, thereby forming an embedded locking structure. This structure enables stable installation of the micro-display module without the need for additional fasteners, reducing display unit displacement caused by vibration, handling, or disassembly during use.

[0126] The upper support 210a can be configured as a cover structure, and a buffer pad, a light-shielding layer, or an elastic support can be installed inside it. When closed, it can protect the micro-display module and lens assembly 4, reduce dust ingress and external light interference, and improve imaging clarity and stability.

[0127] In some embodiments, the image display assembly, lens assembly, and simulation cavity may be arranged along the same observation axis or in a nearly coaxial direction. The simulation cavity 1 is located at the foremost position, with its front opening facing the operator or towards the end of the external auditory canal passage of the ear canal model. The image display assembly is located at the rearmost position, with the lens assembly situated between them.

[0128] With the above arrangement, the tympanic membrane image from the image display component can be optically processed by the lens component and projected onto the vicinity of the transparent membrane 2. This allows the operator to perceive the physical puncture object presented by the solid transparent membrane 2 while also seeing the anatomical or lesion image of the tympanic membrane behind it when observing through an otoscope. This achieves a unified training effect of visual image localization and solid membrane puncture.

[0129] In a preferred embodiment, the distance between the image imaging position and the transparent membrane 2 is controlled within a small range, so that the observer has a visual perception that the tympanic membrane image and the puncture surface are basically coincident at the normal otoscope working distance, thereby improving the accuracy of positioning training.

[0130] The simulated liquid in this invention can not only be used to simulate general middle ear effusion, but also can be configured with different liquid systems according to teaching needs. For example: a low-viscosity transparent liquid for basic puncture and aspiration training; a slightly higher viscosity liquid for simulating viscous secretions; a liquid with slightly varying transparency for simulating different pathological observation experiences; and a liquid to which safe and visible staining components can be added for observing the flow, injection, or aspiration trajectory of the liquid.

[0131] In some implementations, different liquid injection volumes can be preset to create different post-membrane fluid levels and degrees of tympanic membrane bulging. For example, a smaller liquid volume can simulate a mild effusion state, while a larger liquid volume can simulate a significant bulging state, thereby increasing the diversity of training scenarios.

[0132] In a further embodiment, trainees can perform fluid aspiration training after puncture, or simulated drug injection training, such as re-injecting fluid into the cavity through a thin needle, to practice instrument stability and spatial control.

[0133] Based on the above structure, the tympanic membrane puncture simulation device of the present invention can be trained in the following manner.

[0134] First, the image display component is installed inside the support body 210. Then, the lens assembly 4 is sequentially installed in the lens mounting base 42 and each fixing unit, and the initial optical axis alignment is completed through the adjustment structure. Next, the simulation cavity 1 is installed at the front position, with the opening facing the observation direction. The transparent film 2 is led out from the unwinding shaft 61, crosses the opening, and connects to the take-up shaft 62, and is pressed onto the annular bonding surface 13 by the pressing structure. Then, the control module 8, power supply, and necessary data connections are connected.

[0135] By calling up calibration images, tympanic membrane contour diagrams, or teaching images through the control module, the imaging state of the image display component near the transparent membrane 2 after passing through the lens assembly can be observed. The axial position, lateral position, and angle can be finely adjusted through the adjustment structure of the lens mounting base 42. If necessary, the display area and display scale can be adjusted to establish a correspondence between the main anatomical landmarks in the tympanic membrane image and the target puncture area on the transparent membrane 2.

[0136] A predetermined amount of simulated liquid is injected into the simulation chamber 1 through the injection port. The liquid enters through the low-level injection channel 51, while air is discharged through the high-level exhaust channel 52. If air bubbles remain inside, a syringe is connected through the suction port to further aspirate and vent the air, thereby improving liquid uniformity and observation clarity.

[0137] The operator inserts the otoscope from the front of the device or through the external auditory canal via a head mold or ear canal model, gradually locating the tympanic membrane for observation. The operator can adjust the angle, distance, and direction of observation of the otoscope to ensure a clear image of the tympanic membrane processed by the lens assembly and to identify relevant pathological features.

[0138] Based on the location of the lesion and the target quadrant shown in the tympanic membrane image, the operator selects the puncture point and performs puncture on the transparent membrane 2. After puncture, observation of natural fluid outflow, fluid aspiration training, and / or simulated drug administration training can be conducted. Because the transparent membrane 2 itself can be punctured and ruptured, and there is a fluid environment behind it, the training process has a high degree of realism.

[0139] When the current membrane segment is damaged, the damaged membrane segment is removed from the opening by rotating the unwinding shaft 61 and / or the rewinding shaft 62, and a new membrane segment is moved to the opening. The membrane surface is then smoothed, adhered, and sealed again by the tensioning structure 64 and the pressing structure 63. If necessary, the membrane can be refilled before proceeding to the next training cycle.

[0140] Through the above process, tympanic membrane observation, lesion identification, puncture localization, fluid aspiration, drug administration practice, and rapid consumable repositioning can be continuously achieved, which is suitable for teaching, assessment, and equipment familiarization training.

[0141] In some embodiments, the present invention can also be used in conjunction with an otoscope simulation training module to form an otology simulation training system. The system may include an otoscope simulation training module, a tympanic membrane puncture simulation device, a software system, and an external display terminal.

[0142] The otoscope simulation training module can be used for basic tympanic membrane structure identification, lesion recognition, observation path training, and image understanding training; the tympanic membrane puncture simulation device is used for further training in physical puncture, fluid aspiration, and drug administration. Both can be set up independently or integrated into a single platform.

[0143] In the systematic training mode, trainees can first complete theoretical knowledge and lesion image recognition through the otoscope simulation training module, and then transition to the tympanic membrane puncture simulation device to select puncture points and perform actual operations, forming a continuous training chain.

[0144] The software system can connect to a clinical case image library, which can store multiple sets of authorized high-resolution images of tympanic membrane diseases. After the teacher or operator selects the corresponding case on the software interface, the control module 8 receives the instruction, retrieves the image, performs preprocessing, and then transmits it to the image display component 3 for display. To ensure training continuity, a short image loading response time is preferred.

[0145] Teachers can circle, draw lines, or add text prompts for pathological features on the external display interface. The annotations are displayed synchronously on the external terminal and can also be synchronized to the training image interface for demonstration and teaching when necessary.

[0146] In the design process of this invention, the key issue addressed was balancing the potential visibility of pixel structure after magnification via an otoscope with image clarity and realism. Even with a high-resolution micro-display, pixel spacing, light emission boundaries, and optical diffraction can still cause pixelation to become apparent when viewed under 3x to 8x magnification via an otoscope, affecting the realism of the training.

[0147] To address this problem, the present invention employs the following synergistic measures: a high-resolution micro-display screen is selected to improve the basic image sampling capability; the image is optically reduced first by the lens assembly 4 and then magnified by the otoscope to reduce the degree of direct pixel magnification; a microstructure diffusion film is set on the surface of the display screen to break down pixel boundaries; sub-pixel rendering, edge optimization, and contrast compensation are performed before image output; aberration control and distortion pre-compensation are performed on the lens system to avoid image edge blurring and shape distortion.

[0148] Through the above comprehensive design, the operator can see a relatively continuous, clear, and proportionally proportioned tympanic membrane image through the otoscope, rather than a distorted image with obvious pixelation on the monitor. This is particularly important for otology teaching, because pathological features such as the edge of the tympanic membrane perforation, the direction of blood vessels, the reflection of effusion, and local congestion all rely on image detail and morphological fidelity for identification and judgment.

[0149] It should be understood that the materials, dimensions, number of lens layers, focal length, interface type, image processing parameters, control chip model, and driving method listed in the foregoing embodiments are illustrative and not intended to limit the invention. Transparent film thickness range: 0.01-0.1mm; cavity size range: 2.0 * 2.0 * 0.5cm; liquid volume range: 2-4ml; lens focal length range: 30-50mm; external auditory canal length and diameter range: 2.5-3cm; diameter: 0.7-1.0cm. For example: the simulation cavity 1 can use different transparent materials and different shell structures; the transparent membrane 2 can use membrane materials with different thicknesses, different elasticities, and different rupture characteristics; the image display component can use different sizes, different resolutions, and different display technology routes; the lens component can use single-piece, double-piece, multi-piece, aspherical, or composite lens structures; the liquid simulation component can use different pipeline layouts, interface styles, and leak-proof structures; the membrane replacement component can be manually driven or electromechanically driven; the head model or ear canal model 7 can be differentiated according to adults, children, left ear, right ear, and different training goals; the control module 8 can be built into the device body, or some functions can be undertaken by an external host.

[0150] In addition, the specific installation direction of the unwinding shaft 61 and the rewinding shaft 62, the winding method of the transparent film 2, the width of the film belt and the conveying path can also be adjusted according to the overall layout of the device. As long as the functions of removing the damaged film segment, placing the unused film segment in place and reforming the sealed training area can be achieved, they can all be adopted.

[0151] Through the above structure and implementation methods, the present invention has at least the following advantages: (1) By combining the image display component 3 and the lens component 4, the observed tympanic membrane image is made to correspond with the actual puncture membrane surface, thus realizing the integration of observation and operation; (2) By forming a liquid environment through the simulated cavity 1, transparent membrane 2 and liquid simulation component 5, the liquid outflow and aspiration process after puncture can be realistically simulated. (3) The transparent film 2 can be continuously replaced through the unwinding shaft 61, the rewinding shaft 62 and the tensioning structure 64, which facilitates repeated training; (4) The head model or ear canal model 7 forms the external auditory canal pathway 71, which improves the training space constraint and clinical consistency; through the control module 8 and image preprocessing algorithm, the image clarity can be improved, the pixelation can be reduced and the optical distortion can be corrected; it can be combined with the otoscope simulation training module and software system to build a complete otology training platform from basic identification to practical puncture.

[0152] First Embodiment like Figures 1 to 3The diagram shows: a human head model 100 with external auditory canal and tympanic membrane structures; and a middle ear tympanic membrane image simulation processing module 200, which includes: The main support portion 210 includes an upper support portion 210a and a lower support portion 210b; The micro display module 220 includes a micro display screen 221 and a controller 222. The micro display screen 221 is disposed on the first fixing unit 211 of the lower support 210b and is used to display tympanic membrane images. The controller 222 is configured to control the display module of the electronic screen 225 to display tympanic membrane images 223 of different disease states. A lens group 230, disposed between the microdisplay 220 and the pre-used otoscope 224, is used for optically reducing the displayed image. The lens group 230 includes multiple concave lenses, respectively disposed on several fixing units 212 and 213 of the lower support portion. The lens group 230 is designed to form an optical path that reduces the image on the microdisplay and then magnifies it by the otoscope 224, ensuring image clarity. The optical axes of the microdisplay 220 and the multiple concave lenses 231 and 232 are aligned, and the back focus of the screen-lens distance is aligned. A first fixing unit, a second fixing unit, etc., implement a fixing structure; for example, setting a fixing groove in the lower support portion 210b as a fixing unit is just one example. The optical path design further includes an optical path formed from the microdisplay to the lens group 230, then to the pre-used otoscope 224, and finally to the human eye. The reduction factor of the lens group matches the magnification of the otoscope 224. One implementation scheme: The lens group 230 includes at least a first concave lens 231 and a second concave lens 232 arranged sequentially along the optical path; the focal length, refractive index, and air gap between the first concave lens 231 and the second concave lens 232 are configured such that the image displayed on the micro-display screen, after passing through the lens group 231 and 232, forms a virtual image at a preset observation position with a reduction ratio of K; the reduction ratio K matches the inherent magnification M of the otoscope 224 to satisfy the relationship: K * M ≈ 1, so that the visual size observed by the trainee through the otoscope matches that observed when observing a real tympanic membrane. The first concave lens 231 and / or the second concave lens 232 adopt an aspherical design to correct spherical aberration and distortion, ensuring the global sharpness and shape fidelity of the virtual image. Achieving the reduction of the image of the micro-display screen 220 to a ratio that matches the actual tympanic membrane size is the optical core of the entire system's simulation of realism. This process is not simply placing two concave lenses, but a precise design based on optical imaging principles.

[0153] The following will explain in detail the implementation principle, design steps, and integration with medical realism. A single concave lens can diverge light to form a reduced virtual image. However, a single lens has large aberrations and poor image quality. By using a combination of separate, multi-layered concave lenses, and carefully designing the radius of curvature (which determines the focal length), refractive index (material properties), and spacing of each lens, a short focal length negative lens group can be constructed. Its main function is to form a reduced virtual image located in front of a miniature display screen. The size and position of this virtual image are designed to precisely simulate the visual size of a real human eardrum at the working distance of an otoscope. Lens focal length (f): determined by the radius of curvature (R1, R2) and the refractive index (n) of the lens material, following the lens manufacturer's formula. The combined lens focal length (F) includes the combined focal length of the two separate lenses, depending on their individual focal lengths (f1, f2) and the spacing (d) between them. By adjusting these three parameters, the reduction ratio and image position of the final image can be precisely controlled. For an otoscope (which is essentially a lens group or fiber optic lens), its magnification is a fixed value (e.g., 3x or 4x).

[0154] The goal of our training system is to provide an "observed object"—a reduced virtual image—whose physical size (e.g., 4mm wide), after being magnified by an otoscope, appears in the trainee's eye to be exactly the same as the visual size of a real tympanic membrane (e.g., 8mm wide) magnified by the same otoscope. This is a systematic optical design project, typically carried out in the following steps: Step 1: Define Target Parameters (Medical Realism Input) Define the typical size of a real tympanic membrane. For example, the short axis of an adult tympanic membrane is approximately 8-9 mm. The applicant uses 8 mm as the target virtual image size. Define the size of the miniature display screen. For example, a 0.5-inch miniature OLED screen with a diagonal of 12.7 mm, assuming an effective display area width of 10 mm. Then, define the target reduction ratio. Therefore, a 10 mm wide screen image needs to be reduced to an 8 mm wide virtual image. Linear reduction ratio = 8 / 10 = 0.8x (this is an example; the actual reduction ratio may be smaller, such as 0.5x). Determine the location where the virtual image should be placed (e.g., somewhere in front of the lens group). This location should simulate the depth of the real external auditory canal (approximately 2.5 cm) so that the object distance after insertion of the otoscope lens matches that during a real examination.

[0155] Step 2: Initial Lens Selection and Layout. Select two high-performance optical glass or plastic concave lenses. The first lens (closest to the screen) handles the main light divergence, while the second lens is used for further aberration correction and fine-tuning of image position. The focal length f1 of the first concave lens, the focal length f2 of the second concave lens, and the distance d between the two lenses are used as core design variables. An initial model is created using professional optical design software such as Zemax or Code V. The "object" (a miniature display screen) is placed on one side of the lens group. By adjusting f1, f2, and d, optimization is performed in the software to produce a clear, distortion-free virtual image at the target position (simulating the tympanic membrane), with a size meeting the target of 8mm.

[0156] Step 3: Aberration Correction and Optimization (Technical Refinement) is crucial for ensuring sharp and realistic images. Optimization is needed to minimize these aberrations. Spherical aberration causes blurred image edges. This can be corrected by using aspherical concave lenses or combining lenses with different curvatures. Chromatic aberration occurs when different colors of light have different focal lengths, causing color fringes at the edges of colored images. This can be mitigated by using low-dispersion optical materials or compound lens designs. Field curvature occurs when the imaging surface is not a plane but a curved surface. It needs to be "smoothed out" through lens combinations to ensure the entire tympanic membrane image is sharp simultaneously. Barrel or pincushion distortion of the image shape must be strictly controlled, otherwise the tympanic membrane shape will be distorted. A symmetrical lens layout helps reduce distortion.

[0157] Step 4: Specific details of the "fixed units". The "fixed units" should be designed as high-precision lens mounts, ensuring that the optical center (optical axis) of each lens is precisely aligned with the center of the miniature display screen after installation. The distance between the "screen and the first lens" is finely adjusted using precision adjustment mechanisms (such as threaded adjustment rings and shims) so that the display screen is precisely positioned on the "object plane" of the lens group design, thereby obtaining the clearest virtual image. The reduction ratio is not arbitrary but rigorously calculated to ensure that the final visual experience after magnification by the otoscope equals the visual experience of observing a real patient's tympanic membrane. This is a combination of optical engineering and clinical anatomical data. The position of the virtual image is deliberately designed at a specific distance, simulating the actual object distance between the lens and the tympanic membrane after the otoscope is inserted into the external auditory canal. Trainees need to practice focusing and observing at this distance, which is a physical simulation of clinical feel. Strict correction of object aberrations (especially distortion and chromatic aberration) in the optical design is to ensure that the displayed tympanic membrane lesion features (such as the edges of perforations, the direction of blood vessels, and the reflection of effusion) are not distorted or color-distorted. A distorted image can lead to incorrect training and render it medically meaningless. This illustrates the integration of high-precision optical manufacturing with medical imaging diagnostic standards.

[0158] The bottom shape of the lower support 201b is adapted to the shape of the electronic screen display module, achieving a secure mounting. The lens device can also be a three-layer concave lens group, used for multiple optical reduction processing of the image. The chip of the electronic screen display module is connected to an external display device to realize external transmission and control of image signals. The above-described design of the otoscope simulation training system of the present invention includes a micro-display screen and a lens group. The otoscope is an external device. The core is to allow the user to see a clear and continuous image when observing the image on the micro-display screen through the otoscope, without seeing any pixels. There are several technical challenges: First, the resolution of the micro-display screen must be high enough so that no pixels are visible after magnification. Second, the design of the lens group needs to reduce the image on the micro-display screen and then magnify it by the otoscope; the entire optical path must avoid aberrations to ensure image clarity. Third, the pixel arrangement, pixel spacing, and light emission characteristics of the micro-display screen need to be matched with the lens group.

[0159] The applicant's selection of high-resolution microdisplays follows several principles: the higher the pixel density (PPI), the better, as pixels are less noticeable when magnified. However, current microdisplays on the market offer resolutions of 2K or even 4K, with sizes under 1 inch, such as a 0.7-inch Micro OLED display with a resolution of 1920x1200 and a pixel density exceeding 3000 PPI. Therefore, the applicant uses high-resolution microdisplays suitable for industrial or embedded applications. Common types include OLED and LCD. OLEDs are thinner and have higher contrast, but may be more expensive; LCDs offer more choices and better cost-effectiveness. Regarding interfaces, MIPI is the mainstream, suitable for high-speed transmission of high-definition signals. Sizes may range from 0.5 to 2 inches, such as 1.0 inch or 1.39 inches, with resolutions of at least 720p, or even 1080p. The control board is typically a matching driver board that converts HDMI or DP signals into MIPI signals that the screen can accept.

[0160] Regarding the aforementioned challenges, after extensive research, the applicant discovered that even with a high-resolution screen (such as 2K), pixel structures may still be visible after magnification using an otoscope. This presents a challenge in balancing pixel elimination and sharpness. The core reasons are that otoscopes typically have a magnification of 3-8x, pixel pitch becomes more pronounced after magnification, and diffraction and aberrations introduced by the optical system reduce effective resolution. The introduction of multiple concave lenses can cause distortion and dispersion, requiring high precision in optical axis alignment during optical path matching design. To address the challenge of balancing pixel elimination and sharpness, this example involves adding a microstructure diffusion film to the screen surface, such as a frosted film, a microlens array film, or a photolithographic diffusion film, using a diffusion angle of 5-15 degrees. Furthermore, the location of the diffusion layer can be further optimized. The path from the screen surface to the diffusion layer, then to the air gap, and finally to the concave lens group effectively breaks down the pixel structure.

[0161] I. Specific Components. Lens Group Design (Concave Lens Group): The lens group's function is to reduce the image size on the display screen. When observed through the otoscope (magnifying glass), it's equivalent to first reducing the size and then magnifying it, thus offsetting the pixelation caused by the magnifying glass. The reduction factor needs to be calculated so that the final observed image size is similar to the actual size of the tympanic membrane. The lens group design must consider aberration correction, especially spherical aberration and chromatic aberration, which may require multiple lens combinations, or even aspherical lenses. Optical Path Design: From the display screen to the lens group, then to the otoscope, and finally into the eye. It's necessary to ensure that light can pass smoothly through the lens group into the otoscope and form a clear image. Since the otoscope itself is a magnifying glass, its focal length and magnification need to match the reduction factor of the lens group. Pixelation needs to be eliminated: In addition to high resolution, anti-aliasing processing can be performed when displaying the image to smooth the image edges. The system needs to fix the miniature display screen and lens group in a mechanical structure to ensure optical path alignment. Adjustable mechanical structures may also be needed for subsequent calibration.

[0162] In another embodiment of the present invention, the lens group includes: a relay lens group consisting of several concave lenses to reduce the image and correct aberrations; and an exit window layer that matches the otoscope interface as a plano-concave lens, the curvature of which matches the working distance of the otoscope. The lens group may further include: a display layer: a microstructure diffusion film added to the surface of the microdisplay, the microstructure diffusion film including one of a frosted film, a microlens array film, and a photolithographic diffusion film, with a diffusion angle of 5-15 degrees, to achieve pixel reduction; and a field lens layer: a concave lens closely attached to the microdisplay, which uses high refractive index glass with Nd>1.7 to collect large-angle light. In one processing scheme, the display screen can be a Sony ECX339A or an equivalent domestic product, with a size of 0.7-1.03 inches, a resolution of 1920×1200 or 2560×1440, an interface of MIPI-DSI 4-channel, and a brightness of ≥500 nits (to compensate for diffusion loss). The lens assembly is made of H-K9L optical glass, coated with a broadband anti-reflective film (400-700nm), and processed using precision-molded aspherical surfaces. Of course, image processing for the otoscope simulation training system can also be implemented via a controller. This function can be extended. The controller is configured for image processing in the otoscope simulation training system. The controller can include only the driver board integrated with the display screen 221, or it can include additional main control chips. The core of the controller is to acquire raw medical images; perform image preprocessing on the raw medical images to compensate for imaging deviations in the optical system; and output the processed images to the electronic screen display module for observation through the lens assembly and otoscope.

[0163] The simulated cavity 1 has an internal cavity 11 and an opening on the front side. The simulated cavity 1 can be a hollow shell structure, and its shape can be elongated, box-shaped, columnar, or other structural forms suitable for integration and installation. Preferably, the simulated cavity 1 is a transparent shell to facilitate light transmission for observation and adjustment of the internal state. The transparent shell can be made of acrylic, polycarbonate, or other medical transparent polymer materials.

[0164] The transparent membrane 2 covers the opening 12 and cooperates with the simulated cavity 1 to form a sealed cavity. The transparent membrane 2 is a puncture-resistant, flexible membrane, and its material can be polyethylene film, polyurethane film, silicone film, or other membrane materials capable of achieving a puncture and rupture effect. The transparent membrane 2 has a preset thickness and puncture resistance to simulate the resistance and rupture effect during tympanic membrane puncture. The thickness can be adjusted according to the training object and the type of instrument.

[0165] The image display component is located behind the simulated cavity and is used to display the anatomical structure and / or lesion images of the tympanic membrane. The image display component may be a display screen, such as a liquid crystal display, an organic light-emitting diode display, or other miniature image display modules. The displayed content may include one or more of the following: normal tympanic membrane images, tympanic membrane congestion images, secretory otitis media images, effusion images, tympanic membrane perforation images, etc.

[0166] The lens assembly is disposed between the image display component and the simulation cavity 1, and is used to image the image displayed by the image display component 3 onto a clear observation area at or near the location of the transparent membrane 2. The lens assembly may include a single lens or a combination of multiple lenses. By adjusting the focal length, magnification, and lens position, a spatial correspondence can be established between the anatomical landmarks in the image and the target operating area on the transparent membrane 2, allowing the operator to select the puncture point according to the observed image location.

[0167] During training, the operator can use an otoscope to observe the imaging area corresponding to the transparent membrane 2 from the front of the device, locate it according to the displayed tympanic membrane structure and lesion image, and then perform puncture on the transparent membrane 2 to simulate fluid aspiration and / or drug injection.

[0168] The liquid simulation component 5 includes an injection channel 51 and an exhaust channel 52 that communicate with the simulation chamber 1. The injection channel 51 is used to inject transparent liquid into the sealed cavity formed by the transparent membrane 2 and the simulation chamber 1, and the exhaust channel 52 is used to exhaust gas from the cavity.

[0169] The transparent liquid can be water, saline, or a simulated liquid that matches the observation effect of middle ear effusion. By injecting an appropriate amount of transparent liquid into the sealed cavity, the middle ear effusion environment can be simulated, allowing the transparent membrane 2 to show the training effect of liquid outflow, aspiration, or liquid injection after puncture.

[0170] To reduce the impact of air bubbles on image clarity and observation results, the exhaust channel 52 can be connected to a suction port, which is used to connect a syringe or suction device to remove residual air from the sealed cavity. After liquid injection is completed, air bubbles in the cavity can be further removed through the suction port, thereby improving image clarity and training simulation accuracy.

[0171] The membrane replacement assembly 6 includes an unwinding shaft 61 and a take-up shaft 62. The transparent membrane 2 is disposed between the unwinding shaft 61 and the take-up shaft 62 and spans the opening at the front of the simulated cavity 1. When the current membrane segment is punctured and damaged, the punctured membrane segment can be moved away from the opening 12 by rotating the unwinding shaft 61 and / or the take-up shaft 62, and the unused membrane segment can be moved to the opening 12 to re-form a sealed structure.

Claims

1. A tympanic membrane puncture simulation device, characterized in that, include: A simulated cavity, the simulated cavity having an internal cavity and an opening located on the front side; A transparent membrane, which covers the opening and cooperates with the simulated cavity to form a sealed cavity, wherein the transparent membrane is a transparent flexible membrane that can be punctured and broken; An image display component is disposed behind the simulated cavity for displaying images of the tympanic membrane anatomy and / or lesion images; A lens assembly is disposed between the image display assembly and the simulation cavity, and is configured to image the image displayed by the image display assembly onto the location of the transparent film or an observation area adjacent to the transparent film; A liquid simulation assembly, comprising an injection channel and an exhaust channel communicating with the simulation cavity, for injecting simulated liquid into the sealed cavity and venting gas from the sealed cavity; A film changing assembly, comprising an unwinding shaft and a take-up shaft, wherein the transparent film is disposed between the unwinding shaft and the take-up shaft and spans across the opening; Specifically, by rotating the unwinding shaft and / or the rewinding shaft, the punctured and damaged membrane segment is moved away from the opening, and the unused membrane segment is moved to the opening to reform the sealed cavity, thereby allowing the operator to observe and perform the puncture operation using an otoscope.

2. The tympanic membrane puncture simulation device as described in claim 1, characterized in that, The opening has an annular bonding surface around its periphery. When the transparent film is located at the opening, it is bonded to the annular bonding surface to form a circumferential seal of the sealed cavity.

3. The tympanic membrane puncture simulation device as described in claim 2, characterized in that, The film-changing assembly further includes a film-pressing structure, which is disposed at the periphery of the opening and is used to press the transparent film located at the opening onto the annular bonding surface.

4. The tympanic membrane puncture simulation device as described in claim 1, characterized in that, The lens assembly includes at least one imaging lens, which is arranged along the optical path from the image display assembly to the opening. By adjusting the spacing between the imaging lens and the image display assembly and / or the spacing between the imaging lens and the opening, the target anatomical region in the image is imaged at the location of the transparent membrane or its adjacent area.

5. The tympanic membrane puncture simulation device as described in claim 4, characterized in that, The lens assembly is provided with a lens mounting base, which is adjustable relative to the simulation cavity and / or the image display assembly to calibrate the axial position and optical axis alignment of the lens assembly.

6. The tympanic membrane puncture simulation device as described in claim 5, characterized in that, The lens mounting base is provided with at least one of a threaded adjustment structure, a sliding groove adjustment structure, or a shim adjustment structure, for changing the relative position between the lens assembly and the image display assembly to obtain a clear image of the transparent film area.

7. The tympanic membrane puncture simulation device as described in claim 1, characterized in that, The injection channel is located at the lower part or lower side of the simulation cavity, and the exhaust channel is located at the upper part or upper side of the simulation cavity, so that the gas in the cavity is discharged from the upper part during the injection process, thereby reducing the residual air bubbles.

8. The tympanic membrane puncture simulation device as described in claim 7, characterized in that, The exhaust channel is connected to a suction port, which is used to connect a syringe or aspirator to suction and exhaust the sealed cavity after the liquid is injected.

9. The tympanic membrane puncture simulation device as described in claim 7, characterized in that, The injection channel is equipped with an injection port, which is used to connect a syringe, a reservoir, or an infusion line to inject the simulated liquid into the sealed cavity in a measured amount.

10. The tympanic membrane puncture simulation device as described in claim 1, characterized in that, The film changing assembly further includes a tensioning structure disposed on at least one of the unwinding shaft and the rewinding shaft, and / or disposed on the transport path of the transparent film, for applying tension to the transparent film spanning the opening to keep the film surface flat.

11. The tympanic membrane puncture simulation device as described in claim 10, characterized in that, The tensioning structure is a spring preload mechanism, a friction damping mechanism, or a one-way locking mechanism, wherein the one-way locking mechanism is used to restrict the transparent film from retracting in the opposite direction after the transparent film moves to the opening.

12. The tympanic membrane puncture simulation device as described in claim 1, characterized in that, It also includes a head mold or ear canal model, which forms an external auditory canal passage for observation by insertion of an otoscope. The simulated cavity is located at the end of the external auditory canal passage, and the opening faces the external auditory canal passage. At least one of the length, diameter, curvature, and tilt angle of the external auditory canal passage is set according to the anatomical parameters of the human external auditory canal to constrain the insertion path and observation angle of the otoscope.

13. The tympanic membrane puncture simulation device as described in claim 1, characterized in that, It also includes a control module, which is connected to the image display component and configured to control the image display component to switch between displaying different tympanic membrane anatomical structure images and / or lesion images; The control module is further configured to include imaging parameters of the lens assembly and information on the location of the transparent membrane, and to adjust the display area and / or display ratio of the output image so that the target area observed through the otoscope corresponds to the puncture operation area on the transparent membrane.

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