A waterproof and breathable middle ear vent and preparation method thereof

Abstract

The present invention discloses a waterproof and breathable middle ear vent and a preparation method thereof, and belongs to the technical field of medical devices. A waterproof and breathable middle ear vent includes: a vent body, a circuitously arranged bend pipe, and a connecting bottom shell; a vent cavity is provided at the top of the vent body, the bend pipe is provided in the vent body, and the upper end of the bend pipe is connected to the bottom wall of the vent cavity; the lower end of the vent body is detachably fixedly connected to the connecting bottom shell, and the connecting bottom shell is provided with a vertical passage running through itself, and the lower end of the bend pipe is connected to the upper end of the passage; the top surface of the connecting bottom shell is fixedly connected to the side wall of the vent body by a thin rope. The present invention has a simple structure, effectively protects the tympanic membrane, is convenient to disassemble and replace, has a reasonable material composition, the product is breathable and waterproof, and has good biocompatibility, a simple preparation process, and has a good application prospect.

Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and in particular to a waterproof and breathable middle ear vent and a preparation method thereof. Background Art

[0002] The ear consists of three parts: the outer ear, the middle ear, and the inner ear, with the tympanic membrane as the boundary, and the inner side of the tympanic membrane is the middle ear. Otitis media is an inflammatory lesion involving all or part of the structure of the middle ear (including the Eustachian tube, tympanic cavity, tympanic sinus, and mastoid air cells). It can be divided into acute otitis media, chronic suppurative otitis media, and secretory otitis media, and is one of the most common childhood diseases clinically. Secretory otitis media is often treated by tympanic membrane puncture, tympanic cavity injection, and systemic administration, but more severe cases are still prone to occur, and patients with otitis media effusion are viscous and the effusion is not easy to extract. In clinical cases where conservative treatment is ineffective, myringotomy and catheterization surgery are generally used for treatment. However, traditional middle ear ventilation tubes have the following shortcomings: 1. The tympanic membrane is easily damaged in strong winds and other conditions; 2. Poor air permeability and waterproof performance. Summary of the invention

[0003] In order to overcome the defects of the prior art, one of the objects of the present invention is to provide a waterproof and breathable middle ear vent which has a simple structure, effectively protects the eardrum, and is easy to disassemble and replace.

[0004] The second purpose of the present invention is to provide a method for preparing an eardrum ventilation tube, which has a simple process, is suitable for industrial production, and has good application prospects.

[0005] One of the purposes of the present invention is achieved by the following technical solution:

[0006] The present invention provides a waterproof and breathable middle ear vent, comprising: a vent body, a circuitously arranged curved pipe and a connecting bottom shell;

[0007] A ventilation cavity is provided at the top of the ventilation pipe body, the bent pipe is arranged in the ventilation pipe body, and the upper end of the bent pipe is communicated with the bottom wall of the ventilation cavity;

[0008] The lower end of the ventilation pipe body is detachably fixedly connected to the connecting bottom shell, and the connecting bottom shell is provided with a passage vertically passing through itself, and the lower end of the bent pipe is connected to the upper end of the passage; the top surface of the connecting bottom shell is fixedly connected to the side wall of the ventilation pipe body by a thin rope.

[0009] According to another specific embodiment of the present invention, the lower end of the ventilation pipe body is provided with an external thread, and the top of the connecting bottom shell is provided with a connecting ring, the connecting ring is engraved with an internal thread, and the connecting ring cooperates with the lower end thread of the ventilation pipe body.

[0010] According to another specific embodiment of the present invention, a handle is fixed to the top surface of the ventilation tube body.

[0011] According to another specific embodiment of the present invention, an anti-sliding block is fixed to the top outer side wall of the ventilation pipe body.

[0012] According to another specific embodiment of the present invention, the bottom portion connected to the bottom shell is button-shaped.

[0013] According to another specific embodiment of the present invention, the bottom of the connecting bottom shell is oblique.

[0014] According to another specific embodiment of the present invention, the connecting bottom shell is in a long strip shape.

[0015] According to another specific embodiment of the present invention, the vent body, the elbow and the connecting bottom shell are all made of nano waterproof material, and the nano waterproof material includes the following components in parts by weight: 80-100 parts of EPDM rubber; 3-5 parts of poly [(bis-glycine ethyl ester) phosphazene]; 4-8 parts of polylactic acid; 10-20 parts of nano titanium powder; 8-15 parts of nano inorganic powder; 10-15 parts of pore former; and 10-20 parts of solvent.

[0016] The eardrum ventilation tube provided by the present invention uses EPDM rubber as the main material. The EPDM rubber is essentially non-polar, has low water absorption and good aging resistance. Two biodegradable materials, poly[(bis-glycine ethyl ester)phosphazene] and polylactic acid, are added to the formula. Polyphosphazene is a family of macromolecules composed of alternating nitrogen and phosphorus atoms with alternating single bonds and double bonds to form a main chain and organic groups as side groups. The raw material source is sufficient and the production process is pollution-free. Both poly[(bis-glycine ethyl ester)phosphazene] and polylactic acid have good biocompatibility, can reduce the biological repellency of the eardrum ventilation tube during use, and improve the safety performance and comfort of use. In addition, the present invention reasonably controls the poly[(bis-glycine ethyl ester)phosphazene] The dosage of polylactic acid ensures that the eardrum ventilation tube is basically not degraded during use (the expected use time is 1 year), and the product structure will not be damaged; nano titanium powder is a metal material that can improve the ductility of the product, so that the eardrum ventilation tube has a better inner diameter size than the product without titanium powder when the external size of the product is fixed, which helps to improve the efficacy; nano inorganic powder is a filler that can reduce the usage of the main rubber. It is evenly distributed in the product. During the product molding process, the fluidity of the nano inorganic powder and the main rubber is inconsistent, which helps to form the micropores of the product. At the same time, the nano inorganic powder itself has a uniformly distributed microporous structure, so that the product has good air permeability. The role of the pore-forming agent is to form holes, so that the product has a microporous structure and improves the air permeability of the product. The present invention reasonably matches the above components so that the obtained product has good air permeability, good waterproof effect, good biocompatibility, and can obtain a larger inner diameter structure.

[0017] Furthermore, the nano titanium powder is surface coated. The nano titanium powder is protected in the coating layer after the surface coating. After being prepared into the eardrum ventilation tube, the possibility of being oxidized can be greatly reduced, and the surface-treated nano titanium has better dispersibility and can be evenly distributed in the product. Preferably, the nano titanium powder model A180 of Xuzhou Jie Innovation Materials Technology Co., Ltd. can be used.

[0018] Furthermore, the nano-organic powder is a mixture of nano-diatomaceous earth and nano-shell powder, and the nano-diatomaceous earth and the nano-shell powder are mixed in a weight ratio of 1: (0.5-0.8). Nano-diatomaceous earth has a special porous structure, and the interior of the nano-shell powder has a porous fibrous double-helix pore structure. The porous structure of the nano-organic powder and the nano-shell powder provides a good channel for air circulation, so that the product has good air permeability. Nano-diatomaceous earth and nano-shell powder are compounded in the formula to give full play to the advantages of both. Preferably, the weight ratio of nano-diatomaceous earth and nano-shell powder is 1: 0.7. At this ratio, the product has the best air permeability.

[0019] Furthermore, the pore-forming agent is polyethylene glycol, and the solvent is a mixture of water and ethanol, and water and ethanol are mixed in a weight ratio of 1: (0.75-0.9). Preferably, the molecular weight of polyethylene glycol is 1000-2000. Polyethylene glycol can be dissolved in water and ethanol. During preparation, polyethylene glycol is dissolved in a composite solvent of water and ethanol and then mixed with other components. During the curing process, water and ethanol gradually evaporate, and the evaporation of water and ethanol causes the surrounding air temperature to decrease. The temperature reduction causes water molecules in the air to condense on the surface of the product, while EPDM rubber is hydrophobic, while polyethylene glycol is hydrophilic. Water molecules enter the phase-separated polyethylene glycol part to form a water-containing PEG dispersed phase, that is, a phase separation effect is generated, which promotes the generation of micropores in the product, making the product breathable. The film-forming mechanism of polyethylene glycol in the tympanic ventilator of the present invention needs further in-depth study.

[0020] Furthermore, it is prepared by including the following components in parts by weight: 85-95 parts of EPDM rubber; 3-5 parts of poly[(bis-glycine ethyl ester)phosphazene]; 5-8 parts of polylactic acid; 12-18 parts of nano titanium powder; 9-12 parts of nano inorganic powder; 11-14 parts of pore former; and 12-18 parts of solvent.

[0021] The second object of the present invention is achieved by adopting the following technical solution:

[0022] A method for preparing a waterproof and breathable middle ear ventilating tube comprises the following steps:

[0023] The preparation steps of the nano waterproof material are as follows: mixing, firstly mixing a formula amount of nano titanium powder and a nano inorganic powder, and stirring evenly; then adding a formula amount of EPDM rubber, poly [(bis-glycine ethyl ester) phosphazene] and polylactic acid, stirring while gradually heating, heating to 110-135° C., stopping heating, continuing stirring for 25-40 minutes, cooling to 70-90° C., and obtaining a melt; pore forming, adding a formula amount of a pore forming agent to a formula amount of a solvent, stirring evenly, and obtaining a mixture; then adding the mixture to the melt, stirring evenly, injecting into a mold, and solidifying to obtain the nano waterproof material;

[0024] Component preparation and assembly steps: Use the nano waterproof material to prepare the ventilation pipe body, the elbow and the connecting bottom shell respectively, and assemble them to obtain.

[0025] In the mixing step, the present invention adopts a gradient temperature increase operation, i.e., programmed temperature increase. Preferably, the gradient is 50°C per minute. The programmed temperature increase is adopted to gradually melt the materials, and the mixing is more uniform. The nano titanium powder and the nano inorganic powder can be fully and uniformly mixed in the main rubber, and the product has better air permeability. In the pore forming step, the specific shape of the mold matches the shape of the eardrum ventilation tube. The shape and specification of the mold are specifically set according to the preset eardrum ventilation tube shape. The curing can be operated at room temperature. The curing time is preferably 12-24 hours, generally 18 hours.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] (1) The ventilation tube body of the present invention is provided with a ventilation cavity, and the material density can block water molecules without affecting the ventilation effect. Thus, the tympanic membrane ventilation tube is waterproof and breathable; the gas flow of the ventilation tube body is ensured, and the bend is provided to buffer the impact of the gas, effectively protecting the tympanic membrane; a detachable connection bottom shell is provided for easy replacement, cleaning, and recycling.

[0028] (2) The middle ear vent provided by the present invention has a novel formula, which is different from the traditional eardrum vent. It uses terpolymer rubber as the main material and has good hydrophobic properties. The addition of biodegradable materials poly[(bis-glycine ethyl ester)phosphazene] and polylactic acid makes the product green and environmentally friendly, and these two materials have good biocompatibility, which can reduce the biological rejection of the product. The addition of nano-titanium powder has metal ductility, so that the product can obtain a larger inner diameter and improve the efficacy compared with similar products with the same product outer diameter. The nano-inorganic powder and pore-forming agent enable the product to obtain a microporous structure, ensuring that the product has a smooth air circulation path. The formula material provided by the present invention is suitable for preparing eardrum vents of various shapes, including but not limited to button-shaped, T-shaped and oblique-mouthed plug-shaped, and the molding mold can be adjusted according to the preset product shape.

[0029] (3) The method for preparing the middle ear ventilation tube provided by the present invention has a simple process, is suitable for industrial production, and has good application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 It is a schematic structural diagram of a waterproof and breathable middle ear vent provided by a specific embodiment of the present invention;

[0031] Figure 2 It is a schematic diagram of the exploded structure of a waterproof and breathable middle ear vent provided in a specific embodiment of the present invention;

[0032] Figure 3 It is a schematic structural diagram of a bottom of a connecting bottom shell in an oblique shape provided by a specific embodiment of the present invention;

[0033] Figure 4 It is a schematic diagram of a structure in which a connecting bottom shell is in a long strip shape provided by a specific embodiment of the present invention.

[0034] In the figure:

[0035] 1. Ventilation pipe body; 2. Bend pipe; 3. Ventilation cavity; 4. Connecting bottom shell; 5. Handle; 6. Anti-sliding block; 7. External thread; 8. Internal thread; 9. Thin rope. DETAILED DESCRIPTION

[0036] The present invention is further described below in conjunction with the accompanying drawings and specific implementation methods. It should be noted that, under the premise of no conflict, the various embodiments or technical features described below can be arbitrarily combined to form a new embodiment.

[0037] Example 1

[0038] like Figure 1 , Figure 2 , Figure 3 , Figure 4 As shown, a waterproof and breathable middle ear vent includes: a vent body 1, a circuitously arranged curved pipe 2 and a connecting bottom shell 4; a vent cavity 3 is provided at the top of the vent body 1, the curved pipe 2 is arranged in the vent body 1, and the upper end of the curved pipe 2 is communicated with the bottom wall of the vent cavity 3; the lower end of the vent body 1 is detachably fixedly connected to the connecting bottom shell 4, the connecting bottom shell 4 is provided with a passage vertically passing through itself, and the lower end of the curved pipe 2 is communicated with the upper end of the passage; the top surface of the connecting bottom shell 4 is fixedly connected to the side wall of the vent body 1 by a thin rope 9.

[0039] The vent body 1 of the present invention has a vent cavity 3 connected to the outside world at the top. The vent body 1 is made of nanomaterials, and the material density can block water molecules without affecting the air permeability. This makes the tympanic membrane ventilator waterproof and breathable; ensures the gas flow of the vent body 1; and in addition, the bend 2 is provided to buffer the impact of the gas and effectively protect the tympanic membrane; even if part of the high-pressure airflow rushes in, the bend 2 can buffer part of the impact force before entering, greatly reducing the impact force. The connection bottom shell 4 is provided for easy replacement, convenient replacement and installation, and disassembly and recycling, and the structure is simple; when disassembling, the handle 5 can be pulled out of the vent body 1, Figure 1 As shown, the top diameter of the vent body 1 is larger than the lower end of the vent body 1, and the connecting bottom shell 4 is hollow and has a cylindrical structure, and the lower end of the vent body 1 is adapted to the shape and size of the connecting bottom shell 4. The lower end of the vent body 1 is connected to the lower end of the elbow 2; the thin rope 9 can prevent the connecting bottom shell 4 from being separated and lost from the vent body 1, and the thin rope 9 can be connected to the vent body 1 and the connecting bottom shell 4 by bundling or the like.

[0040] The vent body 1, the elbow 2 and the connecting bottom shell 4 are all made of nano waterproof material, and the nano waterproof material includes the following components in parts by weight: 80 parts of EPDM rubber; 3 parts of poly [(bis-glycine ethyl ester) phosphazene]; 4 parts of polylactic acid; 10 parts of nano titanium powder; 8 parts of nano inorganic powder; 10 parts of pore former; 10 parts of solvent. The nano inorganic powder is a mixture of nano diatomaceous earth and nano shell powder in a weight ratio of 1:0.7; the pore former is polyethylene glycol with a molecular weight of 1000-2000, and the solvent is a mixture of water and ethanol, and water and ethanol are mixed in a weight ratio of 1:0.75. The nano titanium powder uses the nano titanium powder model A180 of Xuzhou Jie Innovation Materials Technology Co., Ltd., which is a surface-coated nano titanium powder. The middle ear vent in this embodiment is prepared according to the following method:

[0041] Mixing steps: firstly, mixing the formulated amount of nano titanium powder and nano inorganic powder, stirring evenly; then adding the formulated amount of EPDM rubber, poly [(bis-glycine ethyl ester) phosphazene] and polylactic acid, stirring while gradually heating, heating by 50° C. every 5 minutes, and stopping heating after heating to 125° C., continuing stirring for 30 minutes, cooling to 80° C., and obtaining a melt;

[0042] Pore-forming step: mixing a formulated amount of water and ethanol, then adding a formulated amount of a pore-forming agent, stirring evenly to obtain a mixture; then adding the mixture to the melt obtained above, stirring evenly, injecting into a mold, and curing for 18 hours to obtain a nano waterproof material;

[0043] Component preparation and assembly steps: Use nano waterproof material to prepare the ventilation pipe body 1, the elbow 2 and the connecting bottom shell 4 respectively, and assemble them to obtain.

[0044] According to another specific embodiment of the present invention, the lower end of the vent body 1 is provided with an external thread 7, and a connecting ring is provided on the top of the bottom shell 4, and the connecting ring is engraved with an internal thread 8, and the connecting ring is threadedly matched with the lower end of the vent body 1. The threaded match is provided to achieve detachability, and the connecting ring is sleeved on the lower end of the vent body 1;

[0045] According to another specific embodiment of the present invention, a handle 5 is fixed to the top surface of the vent body 1. The handle 5 is provided to facilitate taking out the vent body 1.

[0046] According to another specific embodiment of the present invention, an anti-sliding block 6 is fixed to the top outer side wall of the ventilation pipe body 1 .

[0047] According to another specific embodiment of the present invention, the bottom portion of the bottom shell 4 is button-shaped. The button-shaped portion is a hollow ring-shaped portion. Figure 1 shown.

[0048] According to another specific embodiment of the present invention, the bottom of the connecting bottom shell 4 is in an oblique shape. Figure 3 shown.

[0049] According to another specific embodiment of the present invention, the connecting bottom shell 4 is in the shape of a long strip. Figure 4 shown. Figure 1 , Figure 3 , Figure 4 The middle connecting bottom shell 4 has different shapes to meet different position requirements.

[0050] Example 2

[0051] The difference between Example 2 and Example 1 is that the preparation formula of the eardrum vent is different, which is as follows: an eardrum vent is prepared by the following components in parts by weight: 100 parts of EPDM rubber; 5 parts of poly[(bis-glycine ethyl ester)phosphazene]; 8 parts of polylactic acid; 20 parts of nano titanium powder; 15 parts of nano inorganic powder; 15 parts of pore former; 20 parts of solvent. The nano inorganic powder is a mixture of nano diatomite and nano shell powder in a weight ratio of 1:0.8; the solvent is a mixture of water and ethanol, and the water and ethanol are mixed in a weight ratio of 1:0.9.

[0052] Example 3

[0053] The difference between Example 3 and Example 1 is that the preparation formula of the eardrum vent is different, which is as follows: an eardrum vent, comprising the following components in parts by weight: 85 parts of EPDM rubber; 3 parts of poly[(bis-glycine ethyl ester)phosphazene]; 5 parts of polylactic acid; 12 parts of nano titanium powder; 9 parts of nano inorganic powder; 11 parts of pore former; 12 parts of solvent. The nano inorganic powder is a mixture of nano diatomite and nano shell powder in a weight ratio of 1:0.6; the solvent is a mixture of water and ethanol, and the water and ethanol are mixed in a weight ratio of 1:0.8.

[0054] Example 4

[0055] The difference between Example 4 and Example 1 is that the preparation formula of the eardrum vent is different, which is as follows: an eardrum vent, comprising the following components in parts by weight: 95 parts of EPDM rubber; 5 parts of poly[(bis-glycine ethyl ester)phosphazene]; 8 parts of polylactic acid; 18 parts of nano titanium powder; 12 parts of nano inorganic powder; 14 parts of pore former; 18 parts of solvent. The nano inorganic powder is a mixture of nano diatomite and nano shell powder in a weight ratio of 1:0.5; the solvent is a mixture of water and ethanol, and the water and ethanol are mixed in a weight ratio of 1:0.85.

[0056] Comparative Example 1

[0057] The difference between Comparative Example 1 and Example 1 is that the preparation formula of the eardrum ventilation tube does not contain nano titanium powder.

[0058] Comparative Example 2

[0059] The difference between Comparative Example 2 and Example 1 is that the preparation formula of the eardrum ventilation tube does not contain nano inorganic powder.

[0060] Comparative Example 3

[0061] The difference between Comparative Example 3 and Example 1 is that the preparation formula of the eardrum ventilation tube does not contain a pore-forming agent.

[0062] Comparative Example 4

[0063] The difference between Comparative Example 4 and Example 1 is that the preparation formula of the eardrum ventilation tube does not contain poly[(bis-glycine ethyl ester)phosphazene] and polylactic acid.

[0064] Effect evaluation and performance testing

[0065] 1. Efficacy and safety experiments

[0066] The middle ear ventilation tubes obtained in Examples 1-4 were taken for efficacy testing. 200 patients with otitis media were selected as research subjects and randomly divided into 4 groups, 50 patients in each group. All patients met the treatment criteria for tympanic ventilation tubes and were informed of this study. The patients and their families signed informed consent. The 4 groups of patients were treated with the tympanic ventilation tubes of Examples 1-4 respectively. Medical staff followed up regularly to record whether tube detachment, ear leakage, tube blockage and other phenomena occurred, and recorded the healing of the tympanic membrane after extubation. The extubation time was determined according to the actual situation of the patient, generally 3-6 months. The patient usage record table is shown in Table 1 below.

[0067] Table 1 Example 1-4 eardrum ventilation tube efficacy and safety experimental results record

[0068]

[0069] From the records in Table 1, it can be seen that when the patients were treated with the middle ear ventilation tubes of Examples 1-4, most of them were able to obtain good results, with low rates of tube dislocation, ear leakage, and tube blockage, and a high rate of healing of the tympanic membrane incision after tube removal. This is due to the reasonable structure of the tympanic membrane ventilation tubes of the embodiments of the present invention and the proper material formula composition. In addition, according to the reactions of 200 patients, there was basically no discomfort caused by hard objects, no allergic phenomena, and no rejection during use.

[0070] 2. Breathable and waterproof

[0071] According to the examples 1-4 and the comparative examples 1-4, the nano waterproof materials were tested for waterproofness and breathability. There is no industry standard for waterproof and breathable verification of eardrum vents in the prior art, so they are made into membrane materials and tested. The test results of the membrane materials can verify the effect of the eardrum vent products. The waterproof performance of the material is tested by the appearance image analysis method. If the contact angle is greater than 90°, it means that the material is hydrophobic and has a good waterproof effect. The moisture permeability is checked with a moisture permeability tester. The greater the moisture permeability, the better the breathability of the material.

[0072] Table 2 Record of experimental results of breathable and waterproof eardrum vents of Examples 1-4 and Comparative Examples 1-4

[0073]

[0074] From the records in the above table, it can be seen that the membrane materials obtained by the eardrum ventilation tube formulas of Examples 1-4 have good waterproof effect and good air permeability. On the contrary, the formulas of Comparative Examples 1-4 are all missing one or more components in the formula of the present invention, and the waterproof and air permeability effects of the products will become worse, which shows that the components in the formula of the present invention are mutually synergistic and indispensable.

[0075] The above-mentioned embodiments are only preferred embodiments of the present invention and cannot be used to limit the scope of protection of the present invention. Any non-substantial changes and substitutions made by technicians in this field on the basis of the present invention shall fall within the scope of protection required by the present invention.

Claims

1. A waterproof and breathable middle ear vent, characterized in that: It includes: a vent pipe body, a circuitously arranged elbow pipe and a connecting bottom shell; A ventilation cavity is provided at the top of the ventilation pipe body, the bent pipe is arranged in the ventilation pipe body, and the upper end of the bent pipe is communicated with the bottom wall of the ventilation cavity; The lower end of the vent body is detachably fixedly connected to the connecting bottom shell, the connecting bottom shell is provided with a passage vertically penetrating the shell, the lower end of the elbow is connected to the upper end of the passage; the top surface of the connecting bottom shell is fixedly connected to the side wall of the vent body by a thin rope; The lower end of the vent body is provided with an external thread, the top of the connecting bottom shell is provided with a connecting ring, the connecting ring is engraved with an internal thread, and the connecting ring is matched with the lower end thread of the vent body; A handle is fixed on the top surface of the vent body; an anti-sliding block is fixed on the top outer side wall of the vent body; The bottom of the connecting bottom shell is button-shaped; or, the bottom of the connecting bottom shell is oblique-shaped; or, the connecting bottom shell is long and strip-shaped; The vent body, the elbow and the connecting bottom shell are all made of nano waterproof material, and the nano waterproof material includes the following components in parts by weight: 80-100 parts of EPDM rubber; 3-5 parts of poly [(bis-glycine ethyl ester) phosphazene]; 4-8 parts of polylactic acid; 10-20 parts of nano titanium powder; 8-15 parts of nano inorganic powder; 10-15 parts of pore former; and 10-20 parts of solvent.

2. A waterproof and breathable middle ear vent as claimed in claim 1, characterized in that: The nano titanium powder is subjected to surface coating treatment.

3. A waterproof and breathable middle ear vent as claimed in claim 1, characterized in that: The nano inorganic powder is a mixture of nano diatomaceous earth and nano shell powder, and the nano diatomaceous earth and the nano shell powder are mixed in a weight ratio of 1: (0.5-0.8).

4. A waterproof and breathable middle ear vent as claimed in claim 1, characterized in that: The pore-forming agent is polyethylene glycol, and the solvent is a mixture of water and ethanol, wherein the water and ethanol are mixed in a weight ratio of 1: (0.75-0.9).

5. A method for preparing a waterproof and breathable middle ear ventilating tube as claimed in any one of claims 1 to 4, characterized in that: The following steps are involved: The preparation steps of the nano waterproof material are as follows: mixing, firstly, mixing the formulated amount of nano titanium powder and nano inorganic powder, and stirring evenly; then adding the formulated amount of EPDM rubber, poly [(bis-glycine ethyl ester) phosphazene] and polylactic acid, stirring while gradually heating, after heating to 110-135° C., stopping heating, continuing stirring for 25-40 minutes, cooling to 70-90° C., and obtaining a melt; Pore ​​forming, adding a formulated amount of pore forming agent to a formulated amount of solvent, stirring evenly to obtain a mixture; then adding the mixture to the melt, stirring evenly, injecting into a mold, and solidifying to obtain a nano waterproof material; Component preparation and assembly steps: Use the nano waterproof material to prepare the ventilation pipe body, the elbow and the connecting bottom shell respectively, and assemble them to obtain.

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