Disposable tympanic membrane ventilation pipe implantation instrument and implantation process

Abstract

The invention relates to the technical field of medical instruments, in particular to a disposable tympanic membrane ventilation pipe implanting instrument and process. The invention discloses a disposable tympanic membrane ventilation pipe implanting instrument. The tympanic membrane ventilation pipe implanting instrument comprises a tympanic membrane puncture knife and an implanting piece which are integrally connected. According to the disposable tympanic membrane ventilation pipe implanting instrument, the tympanic membrane puncture knife and the implanting piece are integrally connected, so that the tympanic membrane puncture knife can puncture the tympanic membrane and generate a tympanic membrane incision suitable for an operation, and the integrated operation of tympanic membrane puncture and tympanic membrane ventilation pipe implanting in the operation process is achieved. By means of the design, the operation process needing to be completed through cooperation of multiple tools in a traditional operation is simplified, the operation steps are reduced, the operation efficiency is improved, meanwhile, the cross infection risk caused by frequent tool replacement is reduced, and the operation process is safer and more convenient.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, more particularly, it relates to a disposable tympanic membrane ventilation tube implanting device and an implanting process. BACKGROUND

[0002] Tympanic membrane ventilation tubes play an important role in the treatment of chronic non-suppurative otitis media and other diseases. Such diseases are common and common, especially in the children group, which seriously affects the hearing of patients. In traditional medical technology, in order to improve the ventilation of the middle ear, it is usually necessary to implant a tympanic membrane ventilation tube into the tympanic membrane of the patient through surgery. This process not only relates to the efficiency of the surgery, but also directly affects the postoperative recovery effect and comfort of the patient. Therefore, the innovation and development of related medical devices are of great significance to improve the quality of surgery and patient experience.

[0003] In the prior art, the method of placing a ventilation tube on the tympanic membrane is as follows: the doctor holds a scalpel to make an incision on the tympanic membrane first, and then holds the ventilation tube with tweezers to send it into the ear canal and place it at the incision of the tympanic membrane. Usually, it depends on a variety of tools to complete the operation. Due to the small space in the ear canal and the small size of the ventilation tube, it is difficult to hold the ventilation tube, and the tympanic membrane ventilation tube is easy to fall into the middle ear cavity, which is difficult to operate, and the operation time is long and the precision is poor. In order to ensure the accuracy of the operation, the doctor also needs to prepare and operate a series of auxiliary instruments, such as needle holders and forceps, to ensure that the ventilation tube is accurately placed in the predetermined position. In addition, multiple contacts and repeated use of surgical instruments further increase the possibility of cross infection, which poses a potential threat to medical safety.

[0004] Therefore, there is an urgent need for a portable and efficient tympanic membrane ventilation tube implanting device that can simplify the surgical steps and further reduce the risk of infection. SUMMARY

[0005] In order to simplify the surgical steps of otitis media, improve the efficiency of the surgery and reduce the risk of infection, the present application provides a disposable tympanic membrane ventilation tube implanting device and an implanting process.

[0006] The present application provides a disposable tympanic membrane ventilation tube implanting device, which adopts the following technical scheme: The disposable tympanic membrane ventilation tube implanting device comprises a tympanic membrane puncture knife and an implanting piece which are integrally connected.

[0007] By adopting the above technical scheme, the tympanic membrane puncture knife can pierce the tympanic membrane and produce a surgical appropriate tympanic membrane incision by integrally connecting the tympanic membrane puncture knife and the implanting part through the one-time tympanic membrane ventilation tube implanting instrument, thereby realizing the integrated operation of tympanic membrane puncture and tympanic membrane ventilation tube implantation in the surgical process. This design simplifies the operation process that needs to be completed by multiple tools in the traditional surgery, reduces the surgical steps, improves the surgical efficiency, and reduces the cross-infection risk caused by frequent tool replacement, so that the surgical process is safer and more convenient.

[0008] In a specific implementable scheme, the implanting part includes a preloaded tube, a push rod is arranged inside the preloaded tube, the tympanic membrane puncture knife includes a puncture needle body, the puncture needle body is arranged on the push rod, a limiting ring is arranged at the connection position of the puncture needle body and the push rod, a limiting sheet is arranged at the corresponding position on the inner diameter of the preloaded tube, and the limiting ring and the limiting sheet are used in cooperation.

[0009] A handle is further arranged on the push rod, and a push assisting rod is arranged on the preloaded tube.

[0010] By adopting the above technical scheme, the tympanic membrane ventilation tube used for implantation can be preloaded into the preloaded tube by arranging the push rod inside the preloaded tube, so that the preparation time in the surgery is reduced and the surgical efficiency is improved. The puncture needle body is arranged on the push rod, and the limiting ring and the limiting sheet are used in cooperation, so that the stroke of the push rod is limited, the surgical appropriate tympanic membrane incision on the tympanic membrane can be accurately produced, the accurate positioning of the push rod when pushing the tympanic membrane ventilation tube is ensured, and damage to the middle ear tissue caused by excessive pushing is avoided. At the same time, this design simplifies the surgical operation steps and improves the safety and reliability of the surgery. The handle arranged on the push rod in the one-time tympanic membrane ventilation tube implanting instrument facilitates the doctor to operate the push rod to push the tympanic membrane ventilation tube, and the push assisting rod arranged on the preloaded tube can assist the push rod to more stably push the tympanic membrane ventilation tube, so as to ensure that the tympanic membrane ventilation tube is accurately placed in the predetermined position, thereby improving the surgical efficiency and accuracy.

[0011] In a specific implementable scheme, the implanting part includes a liquid guide tube, a negative pressure device is arranged at one end of the liquid guide tube, the tympanic membrane puncture knife includes an oblique puncture needle, the oblique puncture needle is arranged at the other end of the liquid guide tube, a fixing ring is arranged on the liquid guide tube close to the oblique puncture needle, an oblique tip is arranged on the side of the oblique puncture needle away from the fixing ring, the included angle between the oblique tip and the axis of the liquid guide tube is 45-75°, and a plurality of adsorption connecting holes are arranged between the oblique tip and the fixing ring.

[0012] By adopting the technical scheme, the slanting puncture needle arranged on the liquid guide tube and having a slanting tip at a certain angle with the axis of the liquid guide tube can accurately puncture the eardrum, reduce the damage to the eardrum and middle ear tissue, improve the safety of the operation, and the combination of the liquid guide tube and the negative pressure device can effectively suck out the middle ear effusion during the implantation of the instrument, keep the inside of the middle ear dry and balance the air pressure, thereby improving the operation efficiency and the postoperative recovery quality of the patient; the adsorption connecting hole is arranged to ensure that the eardrum ventilation tube is firmly adsorbed on the slanting puncture needle during the implantation process, avoid falling into the middle ear cavity, further improve the operation accuracy, reduce the complexity of the operation, and shorten the operation time.

[0013] In a specific implementation scheme, the implanting part includes two clamp handles, one end of the clamp handles is fixedly connected, and the other end is provided with a cross point, the cross point is extended to be provided with an eardrum puncture knife, the eardrum puncture knife includes two clamp handle end parts which are integrally formed with a clamping tip respectively, and the two clamp handles are formed with a pinching operation gap between the fixed connection point and the cross point.

[0014] The width of the clamp handle is gradually reduced from the cross point to the clamping tip.

[0015] By adopting the technical scheme, the structure of the clamp handle adapts to the angle of the human ear canal, improves the convenience and accuracy of the operation, the pinching operation gap realizes the stability of the clamping natural state and the clamping operation space, the eardrum puncture knife formed by the reverse intersection of the clamp handle has a clamping tip, can stably clamp the eardrum ventilation tube in a natural state, and this design can enable the doctor to focus on the travel distance of the implanted eardrum ventilation tube and the ear eardrum opening; after the eardrum ventilation tube is placed in place, only a slight pinch of the tail of the clamp can release the eardrum ventilation tube and smoothly exit the ear canal, complete the operation, and avoid the eardrum ventilation tube from falling into the middle ear cavity during the operation. The close fit between the clamping tip and the eardrum ventilation tube ensures the stability of the eardrum ventilation tube during the implantation process, simplifies the operation steps, improves the operation efficiency, effectively avoids the risk of cross infection, and improves the safety of the operation.

[0016] In a second aspect, the application provides an implanting process of a disposable eardrum ventilation tube implanting instrument, which adopts the following technical scheme: the eardrum ventilation tube implanting instrument can load the eardrum ventilation tube to pass through the working channel and implant in a specified area.

[0017] By adopting the technical scheme, the tympanic membrane ventilation tube implanting instrument can realize accurate implantation of the tympanic membrane ventilation tube, so that the tympanic membrane ventilation tube can be stably loaded on the instrument, and falling off during the operation process is avoided, thereby improving the safety and success rate of the operation. Meanwhile, the structural design of the instrument ensures that the tympanic membrane ventilation tube can smoothly pass through the working channel and accurately reach the designated area, simplifies the operation process, shortens the operation time, reduces the operation difficulty of the doctor, and further reduces the operation risk.

[0018] In a specific implementable scheme, the tympanic membrane ventilation tube comprises a ring chuck, an inner cavity channel is arranged on the ring chuck, and a ventilation tube body is arranged on the inner cavity channel, wherein the ventilation tube body comprises one of a button type, a funnel type, a T type and a bevel type.

[0019] By adopting the technical scheme, the combination design of the ring chuck and the inner cavity channel can stably fix the ventilation tube body, and ensure the stability of the ventilation tube body during the implantation process, so that falling off is avoided. The ventilation tube body adopts the design of the button type, the funnel type or the bevel type, which is respectively suitable for different clinical requirements: the button type is convenient for one-step implantation, the funnel type is beneficial for fluid drainage, and the bevel type is suitable for long and narrow ear canals or specific operation scenes, thereby improving the operation efficiency and adaptability.

[0020] In a specific implementable scheme, the tympanic membrane ventilation tube surface is further deposited with an anticorrosive coating, the anticorrosive coating comprises an inner surface coating and an outer surface coating, the outer surface coating is a deposited parylene coating, and the preparation process of the inner surface coating comprises the following steps: (1) taking parylene powder, gasifying at 150-160℃, and then cracking at 650-700℃ under temperature conditions, and depositing on the inner surface of the tympanic membrane ventilation tube at room temperature; (2) taking carbon oxide nanotubes, adding into toluene containing triphenylphosphine under nitrogen protection, and then adding 1,2-epoxydodecane and silane modified fumed silica into the toluene in sequence, and reacting at 100-120℃ for 12-24h, and then cooling to room temperature, and then adding ethanol to terminate the reaction, and then centrifuging and washing, and then vacuum drying at 50-60℃ for 6-7h to obtain a coating raw material compound; and (3) taking a platinum sheet as a counter electrode, and depositing the coating raw material compound on the parylene layer of the inner surface of the tympanic membrane ventilation tube by electrophoretic deposition under the action of an electric field to form an inner surface coating.

[0021] Preferably, the preparation method of the silane modified fumed silica comprises the following steps: dissolving KH-560 in anhydrous ethanol, stirring, adding 5% glacial acetic acid solution dropwise, adjusting pH to 4-5, stirring at room temperature for 2h, refluxing and stirring at 45℃ for 6h in the ethanol suspension containing fumed silica, cooling to room temperature, suction filtering, vacuum drying at 60℃, and grinding to obtain the silane modified fumed silica.

[0022] Preferably, the mass ratio of 1,2-epoxy dodecane to silane-modified fumed silica is 3:1.

[0023] By adopting the technical scheme, the inner surface and the outer surface of the tympanic ventilation tube are formed with anticorrosive coating, and the corrosion resistance and biocompatibility are effectively improved. Understandably, the inner surface refers to the surface formed by the area inside the tympanic ventilation tube, and the outer surface refers to the area formed outside the tube. Specifically, the outer surface is deposited with conventional pyridium powder through a conventional deposition process; the inner surface coating is prepared through a multi-step process, pyridium powder is deposited to form an anticorrosive coating, and the pyridium powder has a certain carboxyl group to provide a better adhesion effect of the subsequent coating; a carbon nanotube layer is deposited again, the carbon nanotube has a large aspect ratio and a high specific surface area, can form a physical hydrophobic barrier, and can improve the support performance and service life of the coating; the bonding effect of the oxygen-containing functional groups such as carboxyl and hydroxyl on the surface of the oxidized carbon nanotube and pyridium can further improve the interlayer adhesion of the coating, enhance the structural stability of the coating, and improve the anticorrosive effect. Since the tympanic ventilation tube has a certain function of guiding the effusion, the inner surface thereof needs to have excellent hydrophobicity and corrosion resistance to facilitate the solution of the problem. The inventors modify the carbon nanotube by long-chain alkyl and silane modified fumed silica, wherein the epoxy alkyl chain can react with the carboxyl group of the oxidized carbon nanotube, and then the dodecyl chain is grafted on the carbon nanotube to form a hydrophobic support. As the carbon nanotube spreads throughout the coating, the hydrophobicity is greatly improved, the surface energy of the coating is reduced, water droplets are difficult to spread, the hydrophobicity and solvent resistance are improved, and then silane modified fumed silica is added. The epoxy group in the structure of the silane modified fumed silica can react with the carboxyl and hydroxyl groups of the oxidized carbon nanotube, and then the fumed silica is grafted on the surface of the carbon nanotube, further filling the gap of the long-chain hydrophobic structure, distributing multiple hydrophobic particle points in the hydrophobic skeleton, and the distributed silica further improves the strength of the coating to prevent the surface coating from being damaged by the clinical use of the instrument. The two synergistically form a dense and good-strength hydrophobic layer on the carbon nanotube, which can resist corrosive media (such as water, acid, etc.), enhance the corrosion resistance, form a modified coating with good hydrophobicity, good adhesion and corrosion resistance, and improve the barrier performance of the long-chain alkyl and silane modified fumed silica on the surface of the carbon nanotube, thereby improving the hydrophobicity and corrosion resistance of the coating. Then, the middle ear fluid is guided out, and the hydrophobicity and corrosion resistance are improved, thereby promoting the middle ear fluid to be guided out, having the functions of guiding flow and preventing corrosion. If the content of 1,2-epoxydodecane is too low, the arrangement of the hydrophobic chain on the surface of the modified coating will be affected, and the hydrophobic stability and solvent resistance will be reduced. If the content of the silane modified fumed silica is reduced, the density of the hydrophobic coating may be reduced, thereby affecting the barrier performance. The above-mentioned proportions of the present application can achieve good hydrophobic synergistic effect. The outer surface is directly deposited with a pyridium coating to provide excellent biological protection function. The overall technical scheme significantly improves the long-term stability of the tympanic ventilation tube in the human body, reduces the risk of biological liquid corrosion, and improves the operation performance, thereby ensuring a smoother implantation process.

[0024] In summary, the present application has the following beneficial effects: 1. This application utilizes a disposable tympanic membrane ventilation tube implantation device that integrates the tympanic membrane puncture knife and the implant, enabling the tympanic membrane puncture knife to puncture the tympanic membrane and create a suitable surgical incision. This achieves integrated operation of tympanic membrane puncture and tympanic membrane ventilation tube implantation during surgery. This design simplifies the traditional surgical procedure that requires multiple tools, reduces surgical steps, improves surgical efficiency, and reduces the risk of cross-infection caused by frequent tool changes, making the surgical process safer and more convenient. 2. The oblique puncture needle on the drainage tube, with its tip at an angle to the tube's axis, allows for precise puncture of the tympanic membrane, minimizing damage to the membrane and middle ear tissues and improving surgical safety. The combination of the drainage tube and negative pressure device effectively aspirates middle ear fluid during implantation, keeping the middle ear dry and balancing air pressure, thus improving surgical efficiency and postoperative recovery. The suction connection hole ensures the tympanic membrane ventilation tube is firmly attached to the oblique puncture needle during implantation, preventing it from falling into the middle ear cavity, further enhancing surgical precision, reducing operational complexity, and shortening surgical time. 3. Both the inner and outer surfaces of the tympanic membrane ventilation tube are coated with anti-corrosion coatings, effectively improving its corrosion resistance and biocompatibility. Specifically, different coatings are applied to the inner and outer surfaces, ensuring that the outer coating is biocompatible and corrosion-resistant, while the inner coating is hydrophobic and strong, thus facilitating better clinical use of the tympanic membrane ventilation tube. Attached Figure Description

[0025] Figure 1 This is an overall schematic diagram of the disposable tympanic membrane ventilation tube implantation device according to Embodiment 1 of this application; Figure 2 This is a schematic diagram of the concealed pre-loaded tube and the load-bearing button-type tympanic ventilation tube of the disposable tympanic ventilation tube implantation device according to Embodiment 1 of this application; Figure 3 This is a schematic diagram of the disposable tympanic membrane ventilation tube implantation device according to Embodiment 2 of this application; Figure 4 This is a schematic diagram of the disposable tympanic membrane ventilation tube implantation device and the load-bearing funnel-shaped tympanic membrane ventilation tube of Embodiment 2 of this application; Figure 5 This is a schematic diagram of the disposable tympanic membrane ventilation tube implantation device and the load-bearing button-type tympanic membrane ventilation tube according to Embodiment 3 of this application; Explanation of reference numerals: 1. Pre-loaded tube; 2. Push rod; 3. Puncture needle body; 4. Limiting ring; 6. Handle; 7. Push rod; 8. Fluid guide tube; 9. Negative pressure device; 10. Beveled puncture needle; 11. Fixing ring; 13. Adsorption connection hole; 14. Forceps handle; 15. Clamping tip; 117. Button-type ventilation tube body; 217. Funnel-shaped ventilation tube body; 171. Annular chuck; 172. Inner cavity channel. Detailed Implementation

[0026] The following is in conjunction with the appendix Figures 1-5 The following examples further illustrate this application in detail. The carbon nanotubes were purchased from Aladdin, catalog number: C485346; the fumed silica was Evonik AEROSIL R-711; all the raw materials involved in this application are commercially available.

[0027] Preparation Example 1 10g of carbon nanotubes were added to 60ml of mixed acid (concentrated sulfuric acid: concentrated nitric acid = 3:1, volume ratio), refluxed and stirred at 80℃ for 2-4h, washed with water until neutral, and then centrifuged and dried to obtain carbon oxide nanotubes.

[0028] Preparation Example 2 Preparation of silane-modified fumed silica: Dissolve 4g KH-560 in 100ml ethanol, stir, add 5% glacial acetic acid solution dropwise, adjust pH to 5, stir at room temperature for 2h, add 10g fumed silica in 100ml ethanol suspension, reflux and stir at 45℃ for 6h, cool to room temperature, filter, wash 3 times with ethanol, vacuum dry at 60℃, grind to obtain silane-modified fumed silica.

[0029] Example 1 This embodiment discloses a disposable tympanic membrane ventilation tube implantation device.

[0030] like Figure 1 and Figure 2 As shown, the disposable tympanic ventilation tube implantation device is an integrated tympanic puncture knife and implant. The implant includes a pre-loading tube 1, with a push rod 2 inside the pre-loading tube 1. The push rod 2 also has a handle 6, and the pre-loading tube 1 has an assist rod 7, which provides stable support and allows for flexible adjustment and control of the pushing speed when the doctor pushes the push rod 2 during surgery. The tympanic puncture knife includes a puncture needle body 3, which is mounted on the push rod 2. A limiting ring 4 is provided at the connection between the puncture needle body 3 and the push rod 2, and a limiting piece is provided at a corresponding position on the inner diameter of the pre-loading tube 1. The limiting ring 4 and the limiting piece work together to limit the pushing position, so that the puncture needle body 3 forms a suitable tympanic incision at the tympanic membrane, avoiding excessive puncture of the tympanic membrane by the puncture needle body 3 and increasing the surgical risk.

[0031] The implantation process of the tympanic membrane ventilation tube implantation device includes: the tympanic membrane ventilation tube implantation device can carry the tympanic membrane ventilation tube through the working channel, forming a tympanic membrane incision at the tympanic membrane, and then implanting the tympanic membrane ventilation tube into the designated area. The tympanic membrane ventilation tube is detachably sleeved on the limiting ring 4. Through the cooperation of the limiting ring 4 and the limiting piece, the limiting stroke can precisely prevent the tympanic membrane ventilation tube from falling into the middle ear cavity. When it reaches the designated position, the push rod 2 is pushed to place the tympanic membrane ventilation tube. Finally, the push rod 2 is pulled back to complete the operation.

[0032] The tympanic ventilation tube for use with the disposable tympanic ventilation tube implant instrument comprises a ring chuck 171 abutting against the limiting ring 4 to achieve limiting, and an inner cavity passage 172 is arranged on the ring chuck 171, and a ventilation tube main body is arranged on the inner cavity passage 172, and the ventilation tube main body comprises a button type ventilation tube main body 117. The tympanic ventilation tube of the embodiment further has an anticorrosion coating deposited on the surface, and the anticorrosion coating comprises an inner surface coating and an outer surface coating, and the outer surface coating is a deposited parylene coating with a thickness of 5 μm, and the preparation process of the inner surface coating comprises the following steps: (1) taking parylene powder, vaporizing at 150 ℃, and then cracking at a temperature of 650 ℃, and then depositing on the inner surface of the tympanic ventilation tube at room temperature; (2) taking 1.2 g of the carbon oxide nanotube prepared in Preparation Example 1, adding into 50 ml of toluene containing 0.05 g of triphenylphosphine under nitrogen protection, and then sequentially adding 3 g of 1,2-epoxydodecane and 1 g of the silane-modified fumed silica prepared in Preparation Example 2, and then reacting at 100 ℃ for 12 h, and then adding 50 mL of ethanol to terminate the reaction after cooling to room temperature, and then washing by centrifugation, and then vacuum drying at 60 ℃ for 6 h to obtain a coating raw material compound; and (3) taking a platinum sheet as a counter electrode, and then coating the coating raw material compound obtained in the manner of step (2) on the parylene layer deposited on the inner surface of the tympanic ventilation tube by electrophoretic deposition under the action of an electric field to form an inner surface coating with a thickness of 10 μm.

[0033] Example 2 The embodiment discloses a disposable tympanic ventilation tube implant instrument.

[0034] As shown in Figure 3 and Figure 4 The disposable tympanic ventilation tube implant instrument is an integrally connected tympanic puncture knife and implant, the implant comprises a liquid guide tube 8, one end of the liquid guide tube 8 is provided with a negative pressure device 9, the tympanic puncture knife comprises an oblique puncture needle 10, the oblique puncture needle 10 is arranged on the liquid guide tube 8 and away from the other end of the negative pressure device 9, and a cut can be formed at the tympanic membrane through the oblique puncture needle 10, and then the internal effusion of the middle ear can be sucked out through the negative pressure device 9 connected to the liquid guide tube 8, a fixing ring 11 is arranged on the liquid guide tube 8 close to the oblique puncture needle 10, an oblique tip is arranged on the side of the oblique puncture needle 10 away from the fixing ring 11, and the included angle between the oblique tip and the axis of the liquid guide tube 8 is 45°, so that the doctor can better control the size of the tympanic membrane incision in the operation and simplify the operation steps; a plurality of adsorption connection holes 13 are arranged between the oblique tip and the fixing ring 11.

[0035] The implanting process of the tympanic membrane ventilation tube implanting instrument includes that the tympanic membrane ventilation tube can be loaded into the ear canal through the suction connection hole 13, and the tympanic membrane ventilation tube is firmly sucked in the middle part of the bevel puncture needle 10, so that the tympanic membrane ventilation tube is not easily dropped into the middle ear cavity in advance, and the preparation time in the operation is reduced; then the bevel puncture needle 10 can form a suitable tympanic membrane incision at the tympanic membrane, and then the tympanic membrane ventilation tube is implanted into the specified area.

[0036] The tympanic membrane ventilation tube used in cooperation with the disposable tympanic membrane ventilation tube implanting instrument includes an annular chuck 171 which is tightly attached to the fixing ring 11, and can be adsorbed on the inner wall of the tympanic membrane ventilation tube through the suction of the negative pressure device 9 at the same time, and is limited by the suction connection hole 13, and the annular chuck 171 is provided with an inner cavity passage 172, and the inner cavity passage 172 is provided with a ventilation tube main body, and the ventilation tube main body includes a funnel-shaped ventilation tube main body 217, and the accumulated liquid in the middle ear can be sucked out through the funnel-shaped ventilation tube, and the dryness and the balance of the air pressure inside the middle ear are maintained, and after the suction is completed, the negative pressure device 9 is closed, the disposable tympanic membrane ventilation tube implanting instrument is withdrawn, and the operation is completed. The surface of the tympanic membrane ventilation tube of the embodiment further deposits an anticorrosive coating, and the anticorrosive coating includes an inner surface coating and an outer surface coating, and the outer surface coating is a deposited pyridine coating with a thickness of 5 μm, and the preparation process of the inner surface coating includes the following steps: (1) The pyridine powder is gasified at 150℃, and then is cracked at a temperature of 650℃, and is deposited on the inner surface of the tympanic membrane ventilation tube at room temperature; (2) 1.2 g of the carbon oxide nanotube prepared in preparation example 1 is added into 50 ml of toluene containing 0.05 g of triphenylphosphine under nitrogen protection, and then 3 g of 1,2-epoxy dodecane and 1 g of the silane modified fumed silica prepared in preparation example 2 are sequentially added, and the reaction is carried out at 100℃ for 12 h, and after being cooled to room temperature, 50 mL of ethanol is added to terminate the reaction, and after centrifugal washing, the vacuum drying is carried out at 60℃ for 6 h to obtain a coating raw material compound; (3) the platinum sheet is used as a counter electrode, and the coating raw material compound obtained in the step (2) is coated on the pyridine layer deposited on the inner surface of the tympanic membrane ventilation tube through electrophoretic deposition under the action of an electric field to form an inner surface coating with a thickness of 10 μm.

[0037] Example 3 The embodiment discloses a disposable tympanic membrane ventilation tube implanting instrument.

[0038] As Figure 5As shown, the disposable tympanic membrane ventilation tube implanting instrument is an integrated tympanic membrane puncture knife and implanting part, the implanting part includes two forceps handles 14, one end of the forceps handle 14 is fixedly connected, the other end is provided with a cross point, the cross point is provided with a tympanic membrane puncture knife, the tympanic membrane puncture knife includes two forceps handle 14 respectively integrated with a clamping tip 15, the width of the forceps handle 14 is gradually reduced from the cross point to the clamping tip 15, and a pinching operation gap is formed between the fixed connection point and the cross point of the two forceps handles 14. The implanting part is reversely held, the holding feeling of the doctor holding the forceps handle 14 can be improved, so that the clamping tip 15 is kept clamped in a natural state, is adjusted to an angle suitable for the human ear canal, has a reliable surgical field, and the doctor can focus on the tympanic membrane incision. At the same time, after the tympanic membrane ventilation tube is placed in the specified position, the forceps handle 14 is pinched, the tympanic membrane ventilation tube is accurately implanted, the implanting part is conveniently withdrawn from the ear canal, and the operation is completed.

[0039] The implanting process of the tympanic membrane ventilation tube implanting instrument includes that the tympanic membrane ventilation tube implanting instrument can be clamped into the ear canal by the clamping tip 15, so that it is not easy to fall into the middle ear cavity in advance, the surgical steps are simplified, and the surgical efficiency is improved; then the clamping tip 15 can form a suitable tympanic membrane incision at the tympanic membrane, and then the tympanic membrane ventilation tube is implanted into a specified area.

[0040] The tympanic membrane ventilation tube used in cooperation with the disposable tympanic membrane ventilation tube implanting instrument includes a ring-shaped chuck 171, the ring-shaped chuck 171 is provided with an inner cavity passage 172, the inner cavity passage 172 is provided with a ventilation tube main body, and the ventilation tube main body includes a button-shaped ventilation tube main body 117. The tympanic membrane ventilation tube of the embodiment is further deposited with an anticorrosive coating, the anticorrosive coating includes an inner surface coating and an outer surface coating, the outer surface coating is a deposited pyridine coating with a thickness of 5 μm, and the preparation process of the inner surface coating includes the following steps: (1) pyridine powder is gasified at 150 ℃, then is cracked at 650 ℃, and is deposited on the inner surface of the tympanic membrane ventilation tube at room temperature; (2) 1.2 g of the carbon oxide nanotube prepared in preparation example 1 is added into 50 ml of toluene containing 0.05 g of triphenylphosphine under nitrogen protection, then 3 g of 1,2-epoxydodecane and 1 g of the silane-modified fumed silica prepared in preparation example 2 are sequentially added, reaction is carried out at 100 ℃ for 12 h, after cooling to room temperature, 50 ml of ethanol is added to terminate the reaction, after centrifugal washing, vacuum drying is carried out at 60 ℃ for 6 h, and a coating raw material compound is obtained; (3) a platinum sheet is used as a counter electrode, and the coating raw material compound obtained in the mode of step (2) is coated on the pyridine layer deposited on the inner surface of the tympanic membrane ventilation tube by electrophoretic deposition under the action of an electric field, and an inner surface coating with a thickness of 10 μm is formed.

[0041] Example 4 The difference between this embodiment and embodiment 1 is the preparation process of the inner surface coating, which comprises the following steps: (1) taking the pyrolytic graphite powder after gasification at 150°C, cracking at a temperature of 650°C, and depositing on the inner surface of the tympanic ventilation tube at room temperature; (2) taking 1.2 g of the carbon nanotube oxide prepared in preparation example 1, adding it into 50 ml of toluene containing 0.05 g of triphenylphosphine under nitrogen protection, and then sequentially adding 2 g of 1,2-epoxydodecane and 2 g of the silane-modified fumed silica prepared in preparation example 2, reacting at 100°C for 12 h, adding 50 mL of ethanol to terminate the reaction after cooling to room temperature, and centrifugally washing and vacuum drying at 60°C for 6 h to obtain a coating raw material compound; (3) using a platinum sheet as a counter electrode, coating the coating raw material compound on the pyrolytic graphite layer deposited on the inner surface of the tympanic ventilation tube by electrophoretic deposition under the action of an electric field, and forming an inner surface coating with a thickness of 10 μm.

[0042] Embodiment 5 The difference between this embodiment and embodiment 1 is the preparation process of the inner surface coating, which comprises the following steps: (1) taking the pyrolytic graphite powder after gasification at 150°C, cracking at a temperature of 650°C, and depositing on the inner surface of the tympanic ventilation tube at room temperature; (2) taking 1.2 g of the carbon nanotube oxide prepared in preparation example 1, adding it into 50 ml of toluene containing 0.05 g of triphenylphosphine under nitrogen protection, and then sequentially adding 3.5 g of 1,2-epoxydodecane and 0.5 g of the silane-modified fumed silica prepared in preparation example 2, reacting at 100°C for 12 h, adding 50 mL of ethanol to terminate the reaction after cooling to room temperature, and centrifugally washing and vacuum drying at 60°C for 6 h to obtain a coating raw material compound; (3) using a platinum sheet as a counter electrode, coating the coating raw material compound on the pyrolytic graphite layer deposited on the inner surface of the tympanic ventilation tube by electrophoretic deposition under the action of an electric field, and forming an inner surface coating with a thickness of 10 μm.

[0043] Embodiment 6 The difference between this embodiment and embodiment 1 is the preparation process of the inner surface coating, which comprises the following steps: (1) taking the pyrolytic graphite powder after gasification at 150°C, cracking at a temperature of 650°C, and depositing on the inner surface of the tympanic ventilation tube at room temperature; (2) taking 1.2 g of the carbon nanotube oxide prepared in preparation example 1, adding it into 50 ml of toluene containing 0.05 g of triphenylphosphine under nitrogen protection, and then sequentially adding 4 g of 1,2-epoxydodecane, reacting at 100°C for 12 h, adding 50 mL of ethanol to terminate the reaction after cooling to room temperature, and centrifugally washing and vacuum drying at 60°C for 6 h to obtain a coating raw material compound; (3) using a platinum sheet as a counter electrode, coating the coating raw material compound on the pyrolytic graphite layer deposited on the inner surface of the tympanic ventilation tube by electrophoretic deposition under the action of an electric field, and forming an inner surface coating with a thickness of 10 μm.

[0044] Embodiment 7 The difference between this embodiment and embodiment 1 is the preparation process of the inner surface coating, which comprises the following steps: (1) taking the pyrolytic graphite powder after gasification at 150°C, cracking at a temperature of 650°C, and depositing on the inner surface of the tympanic ventilation tube at room temperature; (2) taking 1.2 g of the carbon oxide nanotube prepared in preparation example 1, adding 0.05 g of triphenylphosphine into 50 ml of toluene under nitrogen protection, then sequentially adding 4 g of the silane-modified fumed silica prepared in preparation example 2, reacting at 100°C for 12 h, cooling to room temperature, adding 50 mL of ethanol to terminate the reaction, centrifugal washing, and vacuum drying at 60°C for 6 h to obtain a coating raw material compound; (3) taking a platinum sheet as a counter electrode, and coating the coating raw material compound on the pyrolytic graphite layer deposited on the inner surface of the tympanic ventilation tube by electrophoretic deposition under the action of an electric field to form an inner surface coating with a thickness of 10 μm.

[0045] Embodiment 8 The difference between this embodiment and embodiment 1 is that the inner surface coating only deposits a pyrolytic graphite coating with a thickness of 10 μm.

[0046] Performance detection 1. Acid corrosion resistance test: The tympanic ventilation tubes with the inner and outer surface deposited with the coating of embodiments 1 and 4-8 are tested for acid corrosion resistance. The test process comprises the following steps: weighing the tympanic ventilation tubes with the inner and outer surface deposited with the coating after being placed at a temperature of 70°C for 2 h, then immersing them in a hydrofluoric acid solution with a mass fraction of 10% at a temperature of 70°C for 24 h, washing the inner and outer surfaces of the tympanic ventilation tubes with a slow water flow after being taken out, drying the washed sample, weighing it again, and recording the percentage change of the weight of the sample after immersion.

[0047] 2. GB / T 30447-2013 Nanometer thin film contact angle measurement method: the samples prepared by the inner surface coating process of embodiments 1, 4-8 are observed for the size of the static contact angle and the rolling contact angle of the water droplets and the inner surface coating by using an optical contact angle tester, about 5 μL of deionized water droplets, a water droplet flow rate of 0.5 μL / s, and measuring the inner surface coating at 5 positions to obtain an average value; Table 1: performance detection data of embodiments 1, 4-8 Referring to Table 1, in combination with Examples 1, 4-8, it can be seen that the inner and outer surface coating of the tympanic ventilation tube in Example 1 effectively improves the corrosion resistance thereof, enhances the compactness of the coating, thereby forming a modified coating with good hydrophobicity, good adhesion and corrosion resistance, the adhesion of the deposition-enhanced coating to the substrate of the tympanic ventilation tube is enhanced, and the coating is prevented from falling off; and the overall structural stability of the coating is further enhanced. The inner surface coating is modified by carbon nanotubes, 1,2-epoxy dodecane and silane-modified fumed silica on the surface of the carbon nanotubes, thereby forming a coating with good hydrophobicity, good adhesion and corrosion resistance, so that the long-chain alkyl and silane-modified fumed silica are closely arranged on the surface of the carbon nanotubes, the barrier property is improved, the hydrophobicity and corrosion resistance of the inner surface coating are improved, and the middle ear fluid can be promoted to be discharged, thereby having the effects of flow guiding and corrosion prevention.

[0048] The specific embodiments are merely illustrative of the present application, and are not intended to limit the present application, and those skilled in the art can make modifications to the embodiments without creative contribution after reading the present specification, as long as the modifications are within the scope of the claims of the present application.

Claims

1. A disposable tympanic membrane ventilation tube implantation device, characterized in that, The tympanic membrane ventilation tube implantation device includes an integrally connected tympanic membrane puncture knife and implant.

2. The disposable tympanic membrane ventilation tube implantation device according to claim 1, characterized in that, The implant includes a pre-loading tube (1), and a push rod (2) is provided inside the pre-loading tube (1). The tympanic membrane puncture knife includes a puncture needle body (3), which is disposed on the push rod (2). A limiting ring (4) is provided at the connection between the puncture needle body (3) and the push rod (2). A limiting piece is provided at a corresponding position on the inner diameter of the pre-loading tube (1). The limiting ring (4) and the limiting piece are used in conjunction.

3. The disposable tympanic membrane ventilation tube implantation device according to claim 2, characterized in that, The push rod (2) is also provided with a handle (6), and the pre-installed tube (1) is provided with a push rod (7).

4. The disposable tympanic membrane ventilation tube implantation device according to claim 1, characterized in that, The implant includes a fluid guide tube (8), one end of which is provided with a negative pressure device (9). The tympanic membrane puncture knife includes a beveled puncture needle (10), which is located at the other end of the fluid guide tube (8). A fixing ring (11) is provided on the fluid guide tube (8) near the beveled puncture needle (10). A beveled tip is provided on the side of the beveled puncture needle (10) away from the fixing ring (11). The angle between the beveled tip and the axis of the fluid guide tube (8) is 45-75°. Several adsorption connection holes (13) are provided between the beveled tip and the fixing ring (11).

5. The disposable tympanic membrane ventilation tube implantation device according to claim 1, characterized in that, The implant includes two forceps handles (14), one end of which is fixedly connected and the other end is provided with an intersection point. A tympanic membrane puncture knife is provided extending from the intersection point. The tympanic membrane puncture knife includes a clamping tip (15) integrally formed at the ends of the two forceps handles (14). A pinching operation gap is formed between the fixed connection point and the intersection point of the two forceps handles (14).

6. The implantation process of the disposable tympanic membrane ventilation tube implantation device according to claim 1, characterized in that, The tympanic membrane ventilation tube implantation device can carry the tympanic membrane ventilation tube through the working channel and implant it into the designated area.

7. The implantation process of the disposable tympanic membrane ventilation tube implantation device according to claim 1, characterized in that, The tympanic membrane ventilation tube includes an annular chuck (171), an inner cavity channel (172) is provided on the annular chuck (171), and a ventilation tube body is provided on the inner cavity channel. The ventilation tube body includes one of button type, funnel type, T type and oblique type.

8. The implantation process of the disposable tympanic membrane ventilation tube implantation device according to claim 1, characterized in that, The surface of the tympanic membrane ventilation tube is also deposited with an anti-corrosion coating, which includes an inner surface coating and an outer surface coating. The outer surface coating is a deposited pyrene coating. The preparation process of the inner surface coating includes the following steps: (1) Pyrene powder is vaporized at 150-160℃ and then pyrolyzed at 650-700℃. At room temperature, it is deposited on the inner surface of the tympanic membrane ventilation tube to form a pyrene layer; (2) Carbon oxide nanotubes are taken and added to toluene containing triphenylphosphine under nitrogen protection. Then, 1,2-epoxydodecane and silane-modified fumed silica are added to it in sequence. The reaction is carried out at 100-120℃ for 12-24h. After cooling to room temperature, the reaction is terminated with ethanol. After centrifugation and washing, the mixture is vacuum dried at 50-60℃ for 6-7h to obtain the coating material composite; (3) Using a platinum sheet as the counter electrode, the coating material composite is deposited on the pyrene layer on the inner surface of the tympanic membrane ventilation tube by electrophoretic deposition under the action of an electric field to form an inner surface coating.

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