A tympanic ventilation tube with screw locking, multiple waterproofing and valve control drainage functions

Abstract

The application discloses a tympanic ventilation tube with spiral locking, multiple waterproof and valve control drainage functions, and belongs to the field of ear implant medical devices. The ventilation tube comprises a tube body, an implant device interface is arranged at the outermost end of the tube body, a one-way duckbill valve is arranged at the end close to the external auditory canal, micro-flow ventilation holes are distributed in the circumferential direction of the side wall, a flexible sealing sheet is arranged on the outer side of the tube body, and a continuous single-ring gradually-changing asymmetric spiral fixing structure is arranged on the outer periphery of the middle ear cavity. The spiral fixing structure induces the radial flanging of the tympanic membrane tissue to be embedded between the spiral structure and the outer wall of the tube body to form axial locking through the asymmetric section, and realizes gradual release when reversely rotating through the rise angle, tooth height and round angle gradient; the sealing sheet realizes stable adhesion and controllable peeling through the thickness gradient, pre-stress and surface energy gradient; the micro-flow ventilation holes and the duckbill valve constitute a gas-liquid separation double channel, realize low-resistance ventilation, liquid blocking and pressure-driven drainage. The application can realize stable fixation, water-tight sealing, controllable ventilation, one-way drainage and low-damage implantation and removal.

Description

Invention Name

[0001] A diaphragm ventilator with spiral locking, multiple waterproof features, and valve-controlled drainage. Technical Field

[0002] This invention relates to the field of otological implantation device technology, specifically to a novel tympanic membrane ventilation tube for middle ear ventilation, pressure regulation, and fluid drainage. Background Technology

[0003] Tympanostomy tubes are commonly implanted devices used to treat conditions such as secretory otitis media and Eustachian tube dysfunction. They are used to balance the pressure between the middle ear and the external environment and to drain effusion. Currently, the commonly used T-tubes and mushroom-shaped tubes in clinical practice mainly rely on the axial compression or radial expansion of a rigid structure for fixation, which has the following drawbacks: The fixing method is axial compression or radial expansion, which lacks structural locking and is prone to displacement or detachment. The lack of a continuous sealing interface between the tube and the tympanic membrane perforation allows external fluids to seep into the middle ear cavity along the gap, causing infection. Ventilation and drainage share a single main channel, making it difficult to achieve both low ventilation resistance and high waterproof performance. The lack of a reliable one-way drainage mechanism poses a risk of reverse contamination when water enters the external auditory canal or when pressure fluctuates. Removal often requires direct traction, which can easily cause secondary tearing and damage to the tympanic membrane. Therefore, there is an urgent need for a new type of tympanic ventilator that achieves synergistic optimization among fixed stability, interface sealing, ventilation efficiency, unidirectional drainage, and low-damage operation. Summary of the Invention

[0004] (a) Purpose of the invention A tympanic ventilation tube with the following characteristics is provided: The structure is locked, stable, and can be released in a controlled manner. The tympanic membrane interface is continuously sealed and peelable. Gases pass through with low resistance while liquids enter with restricted flow. Achieve physiological unidirectional drainage Low implantation and removal damage (II) Technical Solution To achieve the above objectives, the technical solution of the present invention is as follows: Figure 1 As shown, the ventilator includes: Hollow tube body (1) The internal hexagonal interface (2) is located at the outermost end of the tube and is used to cooperate with the rotary implantation device. (3) A one-way duckbill valve structure located at the end of the tube near the external auditory canal, with the duckbill-shaped opening facing the external auditory canal. The micro-ventilation hole (4) and the buffer cavity (8) are located on the side wall of the tube and communicate with the main channel of the tube. It unfolds in a ring around the outer periphery of the tube sidewall and is used to cover the implantation site on the outside of the tympanic membrane and form a seal (5). Located on the outer periphery of the middle ear cavity end of the tube, the asymmetric single-turn spiral locking structure (6) induces the tympanic membrane to flip and is embedded and locked by rotation. The above structures are arranged in axial partitions in space and form a coordinated system in function.

[0005] (III) Structural Modules and Mechanisms 1.Tube body like Figure 1 As shown, the tube (1) is a hollow structure with an inner diameter of 0.8–1.0 mm and an outer diameter of 1.0–1.5 mm, used to connect the external auditory canal and the middle ear cavity to achieve gas exchange and liquid drainage. The outermost end of the tube is provided with an internal hexagonal interface (2), which is used to cooperate with the rotating implantation device to complete the rotational implantation and removal of the ventilation tube. Along the axial direction of the tube from the external auditory canal end to the middle ear cavity end, the following are arranged in sequence: a one-way duckbill valve structure (3) near the external auditory canal end, with its duckbill tip facing the external auditory canal; an array of micro-flow ventilation holes (4) located below the duckbill valve, which are circumferentially symmetrically distributed on the side wall of the tube and connected to the buffer cavity; a flexible gradient sealing sheet (5) arranged below the micro-flow ventilation holes, used to cover the implantation opening on the outside of the tympanic membrane after implantation and form a seal; and a spiral locking structure (6) located below the sealing sheet and near the middle ear cavity end, used for implantation locking, fixation and controllable release of the ventilation tube. The bottom end of the tube is a short frustum with a gradually decreasing diameter, forming a near-conical guide head to facilitate the insertion of the tympanic membrane into the tympanic cavity.

[0006] 2. Implant Interface (1) Structure like Figure 2 As shown, the implantation interface (2) is located at the outermost end of the tube body. It is an inscribed regular hexagonal structure with an inscribed circle diameter of 1–1.5 mm and a depth of 0.5–1 mm.

[0007] (2) Working mechanism When performing ventilation tube implantation or removal, the external hexagonal screw of the implantation device is inserted into the internal hexagonal interface. Rotation is used to transmit rotational force to the tympanic membrane ventilation tube. The spiral locking structure enables the ventilation tube to be screwed in or out, avoiding axial traction that could damage the tympanic membrane.

[0008] 3. Duckbill valve (1) Structure The duckbill valve (3) is located near the external auditory canal end of the tube body and is a one-way valve structure made of elastic thin walls. Its inlet cavity faces the middle ear cavity end, and the duckbill opening faces the external auditory canal end. The surface is hydrophobically treated. The diameter of the inlet cavity is 1–1.5 mm, the width of the duckbill cleft is 0.5–0.8 mm, and the top-to-bottom distance is 0.5–1 mm.

[0009] (2) Parameters Opening pressure: 100–200 Pa (3) Working mechanism The duckbill valve and the micro-flow vent create a tiered control system based on opening pressure: gas exchange is preferentially achieved through the micro-flow vent with extremely low opening pressure, while liquid discharge is preferentially achieved through the duckbill valve. The working principle is as follows: Figure 3 As shown, when the effusion in the middle ear increases, the pressure inside the oral cavity rises. Once the opening threshold of the duckbill valve is reached, the duckbill opens from the inside out, allowing the effusion to drain unidirectionally into the external auditory canal. When water enters the external auditory canal or the external pressure increases, the duckbill valve is pressed tightly shut by the external pressure, achieving a watertight seal. The sealing ability increases with the increase of external pressure. Thus, while effectively preventing the backflow of external liquid, unidirectional drainage from the middle ear cavity to the external auditory canal is achieved.

[0010] 4. Micro-flow vents (1) Structural features Micro-ventilation pores (4) are circumferentially distributed on the sidewall of the tube, with a diameter of 20–80 μm and a number of 6–40. The working principle is as follows: Figure 4 As shown. The vent is a smooth, straight, shallow hole. To further enhance the waterproof effect, a non-linear channel structure can be used, with the channel path being curved, zigzag, or labyrinthine. A hydrophobic coating is applied to the vent wall and the inner and outer surfaces. A micro-protrusion structure is provided at the entrance to enhance the liquid-repellent effect, thereby improving the resistance to liquid (7) entry while maintaining capillary regulation. A buffer cavity (8) formed by a local depression of the main channel is provided between the vent and the main channel. This buffer cavity can reduce the probability of viscous liquid in the middle ear directly contacting the micropores, thus providing a certain degree of anti-pollution and anti-blockage ability.

[0011] (2) Working mechanism When the gas passes through the capillary, it is in a low Reynolds number laminar flow state, and the total ventilation flow rate is described by the Hagen-Poiseuille equation: Q total = n·(πr 4 / 8μL)·ΔP. Where: Q total denoted as total ventilation flow rate; n as the number of capillary pores; r as the radius of a single pore; L as the effective radial length of the vent; μ as the gas dynamic viscosity; and ΔP as the pressure difference between the inside and outside of the pore.

[0012] Using parameters close to clinical practice: ΔP = -10 Pa (the pressure difference between the inside and outside of the tympanic cavity is approximately -150 to 50 Pa), r = 25 μm (orifice diameter 50 μm), L = 50 μm, n = 6, μ = 1.8 × 10⁻⁶. -5 Pa·s, substituting into the formula, we can obtain Q. totalThe gas exchange rate is approximately 10 μl / s, or 36 ml / h, far exceeding the daily gas exchange requirement of about 2 ml under normal middle ear conditions. This indicates that the microstructure already possesses significant redundant ventilation capacity under low pressure differential conditions, thus providing ample design space for subsequent improvements in waterproofing performance by reducing the pore size or increasing channel complexity.

[0013] For a liquid to pass through a micropore, it must overcome capillary pressure, described by the Laplace equation: ΔP = 2γcosθ / r. Where: ΔP is the critical pressure that must be overcome for the liquid to enter the micropore; γ is the surface tension of the liquid; θ is the contact angle of the liquid on the pore wall; and r is the capillary radius.

[0014] The surface tension of the water sample is γ≈0.072 N / m, the pore radius is r=25 μm, and the contact angle of the hydrophobic surface of the pore wall is θ=120°. Substituting these values ​​into the formula, ΔP≈2880 Pa is calculated. This result means that approximately 2880 Pa of positive pressure is required on the external auditory canal side for water to penetrate the micropores and enter the main channel. This threshold pressure is significantly higher than the pressure in everyday showering or splashing scenarios. Except for special cases such as swimming or snorkeling, liquid is unlikely to penetrate.

[0015] Building upon this, if the micro-ventilation orifice is designed as a curved or zigzag-shaped non-linear channel structure, its liquid barrier performance can be further enhanced. When liquid attempts to enter the channel, a meniscus interface must be reformed at each geometric inflection point, and the additional pressure from interfacial tension must be overcome again, thus forming a multi-stage series of capillary barriers, significantly increasing the equivalent entry pressure. Simultaneously, the non-linear structure alters the instantaneous flow path of the liquid, reducing the likelihood of forming a continuous, penetrating liquid column under short-term pressure impact, and further suppressing liquid permeation by increasing the flow path length and local resistance. In contrast, gas, due to its lower viscosity and lack of interfacial tension limitation, can still pass smoothly under the drive of a small pressure difference, even in the presence of curved or complex channels. Therefore, through the synergistic design of channel size, surface wettability, and spatial path, the threshold pressure for liquid entry can be significantly increased while ensuring ventilation capacity, thereby achieving stable and reliable gas-liquid selective transport characteristics.

[0016] 5. Flexible gradient sealing sheet (1) Structural features The flexible gradient sealing sheet (5) is integrally formed with the tube body, and has an annular unfolded structure with a diameter of 1.5–2 mm, an inner thickness of 0.15–0.25 mm, and an outer edge thickness of ≤0.05 mm. The sealing sheet cross-section forms an angle with the tube body axis that tilts towards the middle ear cavity, with an angle of approximately 60°–70°, and the cross-sectional edge is rounded. The sealing sheet is completely transparent, and its surface is treated with anti-fouling coating.

[0017] (2) Surface energy gradient The sealing sheet and the diaphragm contact surface are constructed with a radially partitioned surface energy gradient structure, consisting of a hydrophobic water-blocking zone, a transition gradient zone, and a hydrophilic sealing zone from the outside in. The surface energy of the outer hydrophobic zone is approximately 8–18 mN / m, corresponding to a contact angle of 110°–140°, which is used to inhibit liquid penetration inward along the interface. The surface energy of the intermediate transition zone increases continuously or in segments from approximately 20 mN / m to approximately 45 mN / m, and the contact angle gradually decreases from approximately 90° to approximately 50°, forming a directional wetting driving force to guide the controlled spread of liquid. The surface energy of the inner hydrophilic zone is approximately 60–75 mN / m, corresponding to a contact angle of 0°–30°, which is used to promote liquid spread and fill the interfacial micro-gaps, thereby forming a stable liquid sealing layer under low contact pressure conditions and achieving effective waterproofing.

[0018] (3) Prestressed design The sealing strip is slightly curved toward the middle ear cavity in its free state, and after implantation, it generates a preset contact pressure of about 0.5–3 kPa on the tympanic membrane.

[0019] (4) Working mechanism The sealing sheet and the spiral locking structure work together to achieve a sealing effect, as follows: Figure 5 As shown. The sealing effect of the sealing strip depends on the coupling effect of liquid spreading driven by surface energy gradient and pre-stress contact pressure. After implantation, the sealing strip (5) automatically adheres to the outside of the tympanic membrane (9), covering the implantation site and the surrounding part of the tympanic membrane; its preset tilt angle and pre-stress bending make the sealing strip fit tightly with the tympanic membrane, the hydrophilic area of ​​the inner edge promotes the spreading of a small amount of liquid to fill the micro gaps at the interface and enhance the seal, while the hydrophobic area of ​​the outer edge prevents liquid diffusion and infiltration. When the ventilation tube is removed, the flexible area of ​​the outer edge of the sealing strip peels off first, and then the peeling spreads radially inward until the sealing strip is completely separated from the tympanic membrane, achieving non-damaging removal.

[0020] 6. Spiral locking structure (1) Basic structure The spiral locking structure (6) is located on the outer periphery of the middle ear cavity end of the tube body. It is a continuous single-turn asymmetrical cross-section spiral flange with 1.0–1.5 turns. The thread near the middle ear cavity end has two optional designs depending on clinical needs: one is an inlet design, with the end gradually flattened and transitioning to a smooth rounded corner, suitable for cases where tympanostomy has been performed in advance by instruments or laser; the other is a cutting edge design, with the end gradually flattened and connected to a single blade with a rounded back, which can simultaneously complete tympanostomy and ventilation tube implantation without pre-prepared tympanostomy. The rise angle and tooth height of the thread near the external auditory canal end gradually decrease, transitioning to an exit slope to facilitate smooth withdrawal when rotating in the opposite direction.

[0021] (2) Geometric parameters Helix angle: 5°–20°; Pitch: 0.2–0.5 mm; Tooth height: 0.15–0.3 mm; Corner radius: 0.02–0.05 mm.

[0022] (3) Cross-sectional features The thread cross-section is asymmetrical: the lower side is a gentle slope with a tooth flank angle of about 55°–70°; the upper side is a steep slope with a tooth flank angle of about 10°–20°; both the tooth crest and the tooth root are rounded, with the tooth root rounded corner radius being about twice that of the tooth crest rounded corner radius, in order to reduce stress concentration; a shallow groove can be provided at the junction of the thread steep slope and the pipe wall to facilitate the embedding of tympanic membrane tissue.

[0023] (4) Working mechanism When the diameter of the tympanic membrane incision is slightly smaller than the outer diameter of the ventilation tube, this structure induces the tympanic membrane (9) to locally elastically fold and embed itself between the spiral structure and the outer wall of the tube during ventilation tube implantation, forming an axial mechanical lock, rather than relying on radial clamping or elastic support for fixation. The principle is as follows: Figure 5 As shown. The specific implantation locking process is as follows: the rotational force is converted into tangential force through the internal hexagonal interface; the lower end of the thread enters the area below the tympanic membrane through the tympanic membrane incision hole; as the rotation progresses, the steep slope on the upper side of the thread gradually lifts the tympanic membrane, inducing the edge of the tympanic membrane to undergo elastic outward deformation and embed itself between the spiral structure and the outer wall of the tube; when the outward slope of the thread is completely inserted into the tympanic membrane, the entire spiral locking structure is located on the inner side of the tympanic membrane, forming a double-sided axial mechanical lock together with the flexible gradient sealing sheet (5) on the outer side of the tympanic membrane.

[0024] When removing the ventilator, the process is as follows: Reverse rotation converts the rotational force into a tangential force; the threaded exit ramp enters above the tympanic membrane from the tympanic cavity; as rotation continues, the tympanic membrane flange gradually retracts and releases from between the spiral structure and the outer wall of the tube, and the thread is gradually unscrewed; finally, the spiral locking structure completely disengages from the tympanic membrane, achieving a damage-free release of the ventilator.

[0025] (iv) Collaborative Working Mechanism This invention achieves gas-liquid separation regulation through the synergistic effect of the above-mentioned multi-structure, organically unifying the three functions of ventilation, drainage, and waterproofing: Ventilation: When there is a pressure difference between the inside and outside of the ventilation tube, the gas is continuously exchanged with low resistance through the micro-flow vents on the side wall of the tube, and the ventilation volume meets the physiological needs of the middle ear.

[0026] Drainage: When the pressure rises to the opening threshold of the duckbill valve due to fluid accumulation in the middle ear cavity, the duckbill valve opens in one direction under pressure, and the fluid is discharged from the middle ear cavity to the external auditory canal; after drainage, the pressure decreases and the valve closes automatically.

[0027] Waterproofing: When there is liquid in the external auditory canal or the pressure increases, waterproofing is achieved through the following four mechanisms working together: the duckbill valve closes one-way under external pressure; the flexible gradient sealing sheet forms a continuous sealing interface on the outside of the tympanic membrane; the capillary hydrophobic effect of the micro-ventilation pores prevents liquid from seeping in; and the spiral locking structure and its fit with the tympanic membrane block the liquid passage at the structural level.

[0028] Thus, the low resistance requirement for ventilation and the high liquid resistance requirement for waterproofing can be compatible in the same device, achieving functional synergy rather than mutual constraint. Attached Figure Description

[0029] Figure 1 : A front view and longitudinal sectional view of the overall structure of the present invention.

[0030] Figure 2 : Cross-sectional view of the implantation interface.

[0031] Figure 3 Schematic diagram of the working principle of the duckbill valve in open and closed states.

[0032] Figure 4 Schematic diagram of the principle of micro-flow ventilation and capillary liquid resistance.

[0033] Figure 5 : A schematic diagram showing how the spiral locking structure and the flexible gradient sealing sheet work together to achieve watertight fixation. Detailed Implementation

[0034] In one embodiment, the tympanic membrane ventilation tube provided by the present invention is a one-piece molded structure, made of medical-grade silicone or thermoplastic elastomer material. The ventilation tube has an outer diameter of 1.2 mm, an inner diameter of 0.9 mm, and a total length of approximately 5 mm. The inner diameter of the hexagonal socket is 1.2 mm, and the depth is 0.7 mm. The duckbill valve has an inlet diameter of 1.2 mm, a duckbill cleft width of 0.6 mm, a top-to-bottom distance of 0.8 mm, and an opening pressure setting of approximately 150 Pa. There are 12 micro-flow vents, each with a diameter of 50 μm and an effective flow length of 50 μm, connected to the main channel through a buffer cavity. The flexible gradient sealing sheet has an outer diameter of 2.0 mm, an inner thickness of 0.2 mm, an outer edge thickness of 0.04 mm, and an inclination angle of 65°. The spiral locking structure is a 1.25-turn right-hand thread with a pitch of 0.35 mm and a thread height of 0.2 mm, employing an inlet-type design with smooth rounded ends.

[0035] (1) Implantation process A 1mm diameter circular hole is pre-drilled in the lower anterior quadrant of the tympanic membrane using a laser. An external hexagonal rotating implantation instrument is inserted into the internal hexagonal interface, allowing the guide head and threaded end of the tube to pass through the incision and enter beneath the tympanic membrane. Rotating the ventilation tube gradually elevates the tympanic membrane due to the steep slope on the upper side of the thread, inducing the membrane edge to elastically fold and embed itself between the helical structure and the outer wall of the tube. With continued rotation, the helical locking structure fully enters the inner side of the tympanic membrane, while the flexible gradient sealing plate on the outer side of the tube automatically adheres to the outer surface of the tympanic membrane. At this point, the helical locking structure and the sealing plate together form a bilateral axial mechanical lock and contact seal on the tympanic membrane. The entire procedure is a rotational operation, requiring no axial pressure or traction, effectively reducing implantation trauma.

[0036] (2) On-the-job status When a pressure difference exists across the tympanic membrane, air is exchanged with low resistance through the micro-ventilation orifice, ensuring adequate ventilation for the middle ear's physiological needs. When fluid accumulates in the middle ear cavity, causing the pressure to rise to the opening threshold of the duckbill valve, the valve opens unidirectionally from the inside out, allowing fluid to drain into the external auditory canal. After drainage, the valve automatically closes as the pressure decreases. In environments with fluid in the external auditory canal or increased external pressure, the waterproofing function is achieved through a four-pronged mechanism: the duckbill valve closes unidirectionally under external pressure; a flexible gradient sealing sheet forms a continuous liquid seal interface on the outside of the tympanic membrane; the capillary hydrophobic effect of the micro-ventilation orifice prevents liquid penetration; and the spiral locking structure mechanically interlocks with the tympanic membrane, structurally blocking the fluid pathway.

[0037] (3) Removal process When the ventilation tube needs to be removed, reinsert the implanted device into the hexagonal connector and rotate it in the opposite direction. The threaded exit ramp first enters the tympanic membrane perforation, and the tympanic membrane flange gradually retracts and releases from between the spiral structure and the outer wall of the tube. The spiral locking structure then slowly unscrews out. Simultaneously, the flexible gradient sealing disc peels off from the outer flexible area and gradually detaches from the tympanic membrane radially inward. Finally, the spiral locking structure completely detaches from the tympanic membrane, and the ventilation tube is smoothly withdrawn, avoiding secondary tearing damage to the tympanic membrane.

Claims

1. A tympanic membrane ventilation tube with spiral locking, multiple waterproof and valve-controlled drainage functions, comprising a hollow tube body (1), an internal hexagonal interface (2) disposed at the outermost end of the tube body (1), a one-way valve structure (3) disposed at the end of the tube body (1) near the external auditory canal, a micro-ventilation hole (4) disposed on the side wall of the tube body (1), a flexible sealing sheet (5) disposed on the outer periphery of the side wall of the tube body (1), and a spiral locking structure (6) disposed on the outer periphery of the middle ear cavity end of the tube body (1), characterized in that: The internal hexagonal interface (2) is used to cooperate with a rotary implantation device; The one-way valve structure (3) forms a liquid discharge channel along the axial direction of the pipe body; The micro-ventilation holes (4) form a gas exchange channel along the radial direction of the tube body; The flexible sealing sheet (5) is used to form a sealing interface on the outside of the tympanic membrane; The spiral locking structure (6) is used to embed the tympanic membrane tissue between the spiral structure and the outer wall of the tube during the screwing process to achieve axial fixation; The one-way valve structure (3) and the micro-flow vent (4) respectively constitute a liquid discharge channel and a gas exchange channel to achieve gas-liquid separation and transmission.

2. The tympanic membrane ventilation tube according to claim 1, characterized in that: The internal hexagonal interface (2) is located in the inner cavity of the external auditory canal and is used to cooperate with the corresponding drive end of the rotating implantation device.

3. The tympanic membrane ventilation tube according to claim 1, characterized in that: The one-way valve structure (3) is an elastic one-way opening structure located near the external auditory canal end of the tube, comprising: At least one deformable elastic closure; The closure is in a closed state when the pressure in the external auditory canal is higher than the pressure in the middle ear; When the pressure in the middle ear is higher than the pressure in the external auditory canal and reaches the opening threshold, elastic deformation occurs to form a fluid channel; The opening pressure threshold of the check valve is 100–200 Pa.

4. The tympanic membrane ventilation tube according to claim 3, characterized in that: The one-way valve structure (3) is a duckbill valve, which has an opposing elastic lip structure. The elastic lip is in a pre-converged state in its natural state and opens and deforms along the axial direction under pressure to form a fluid channel.

5. The tympanic membrane ventilation tube according to claim 1, characterized in that: The micro-ventilation pore (4) has the following characteristics: The diameter is 20–80 μm; The quantity ranges from 6 to 40. They are distributed at intervals along the circumference of the pipe and penetrate the side wall of the pipe to communicate with the inner cavity of the pipe.

6. The tympanic membrane ventilation tube according to claim 1, characterized in that: The micro-ventilation pore (4) has the following structural features: The inner wall of the micro-ventilation pore (4) is hydrophobic and has a continuous smooth structure; The micro-flow vent (4) is a straight channel or a non-straight channel structure, wherein the channel path of the non-straight channel structure is any one or a combination of curved, broken line or maze type. The surface of the micro-ventilation pore (4) has a hydrophobic coating, a micro-structured hydrophobic surface, or a combination of the two to form a hydrophobic structure; The micro-ventilation hole (4) is connected to the main channel of the tube body, and a buffer cavity (8) is provided between the ventilation hole and the main channel.

7. The tympanic membrane ventilation tube according to claim 1, characterized in that: The flexible sealing sheet (5) has a continuous annular structure and is a thin sheet that extends radially outward.

8. The tympanic membrane ventilation tube according to claim 7, characterized in that: The flexible sealing sheet (5) simultaneously has: Gradient thickness structure where the outer edge thickness is less than the inner edge thickness; A prestressed structure with a predetermined bending direction; A surface energy gradient, varying from hydrophobic to hydrophilic, is formed radially on the contact surface with the tympanic membrane.

9. The tympanic membrane ventilation tube according to claim 1, characterized in that: The spiral locking structure (6) is a single-turn or 1–1.5-turn continuous spiral, and its radial cross-section is asymmetrical, including: A gentle slope in the direction of insertion; Steep slope on the side opposite to the insertion direction; A groove structure is formed between the steep slope and the outer wall of the pipe.

10. The tympanic membrane ventilation tube according to claim 1, characterized in that: The spiral locking structure includes, along the axial direction: The introductory segment located on the side of the middle ear has a flat, smooth, rounded or cut structure at its front end; The outflow slope structure located on the side of the external auditory canal; The inlet section is used to guide the tube into the tympanic membrane when there is a pre-set tympanic membrane incision and to simultaneously complete the tympanic membrane incision and tube introduction when there is no pre-set tympanic membrane incision. The outlet slope is used to release tissue when rotating in the opposite direction.

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