Tympanic membrane ventilation drainage tube and manufacturing method thereof

Abstract

The invention provides a tympanic membrane ventilation drainage tube and a manufacturing method thereof. The manufacturing method comprises the following steps: manufacturing a first-stage metal blank through machining; the first-stage green body is provided with a channel extending in the axial direction of the first-stage green body in a penetrating mode; at least arranging a polymer coating on the wall of the channel of the first-stage green body to obtain a second-stage green body; the wall of the channel of the second-stage blank body is at least polished, a tympanic membrane ventilation drainage tube base body is obtained, and the roughness of the wall of the channel of the tympanic membrane ventilation drainage tube base body can be reduced to 0.05-0.1 micron.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a tympanic membrane ventilation and drainage tube and a manufacturing method thereof. Background Art

[0002] Tympanostomy tubes are used for secretory otitis media and Eustachian tube dysfunction. In clinical practice, after tympanostomy tube placement, the patient's middle ear effusion and blood clots are often adsorbed on the wall of the tympanostomy tube cavity, resulting in tube blockage.

[0003] Most of the tympanic membrane ventilation and drainage tubes in the prior art have been improved to reduce the occurrence of tube blockage by improving the structure of the tympanic membrane ventilation and drainage tubes, such as designing a larger inner cavity structure or a larger flange structure, so that the tympanic membrane ventilation and drainage tube can be hung on the tympanic membrane by using the flange structure, so that when there is a lot of fluid accumulation in the middle ear, the purpose of draining the fluid can be achieved by squeezing the effusion. However, these tympanic membrane ventilation and drainage tubes are generally large in size and heavy in weight, which increases the patient's discomfort in the ear. Moreover, after being placed, these tympanic membrane ventilation and drainage tubes are close to the ossicular chain, which is prone to touching and damaging the ossicular chain.

[0004] Research has found that the smoother and more hydrophilic the surface of the tympanic membrane ventilation and drainage tube is, the less likely it is for effusion and blood crust to accumulate. However, existing tympanic membrane ventilation and drainage tubes are mostly made of metals such as titanium or titanium alloys. Regardless of titanium or titanium alloy, due to its material properties, its surface roughness after machining is as high as 0.2μm to 0.4μm, and its surface roughness after polishing is still within 0.15μm to 0.2μm. Summary of the invention

[0005] The object of the present invention is to provide a tympanic membrane ventilation and drainage tube and a manufacturing method thereof, aiming to further reduce the surface roughness of the inner cavity of the tympanic membrane ventilation and drainage tube, facilitate drainage, and reduce the occurrence of tube blockage.

[0006] To achieve the above object, the present invention provides a method for manufacturing a tympanic membrane ventilation and drainage tube, comprising:

[0007] Step S1, manufacturing a primary metal blank by machining; the primary metal blank has a channel extending through the primary metal blank along its own axial direction;

[0008] Step S2, providing a polymer coating at least on the wall of the channel of the primary body to obtain a secondary body;

[0009] Step S3, polishing at least the wall of the channel of the secondary blank to obtain a tympanic membrane ventilation and drainage tube base.

[0010] Optionally, the step S2 further comprises providing the polymer coating on other surfaces of the primary body except the wall of the channel; the step S3 further comprises polishing other surfaces of the secondary body except the wall of the channel; and / or,

[0011] The manufacturing method further comprises:

[0012] Step S4, providing a drug coating on at least a portion of the surface of the tympanic membrane ventilation and drainage tube substrate.

[0013] Optionally, step S2 includes:

[0014] Step S21, providing a transitional bottom layer at least on the wall of the channel of the primary body;

[0015] Step S22, providing a hydrophilic layer on the transitional bottom layer;

[0016] The step S3 includes polishing the wall of the channel of the secondary body by using a fluid polishing process.

[0017] Optionally, the thickness of the transitional bottom layer is 15 μm to 60 μm, and the thickness of the hydrophilic layer is 3 μm to 5 μm.

[0018] Optionally, the transitional bottom layer is formed by solidifying a first solution coated at least on the wall of the channel of the primary body;

[0019] The components of the first solution include benzophenone-based monomer, acrylic acid, and solvent; and in the first solution, the mass ratio of benzophenone-based monomer, acrylic acid, and solvent is (3-18):(86-95):100.

[0020] Optionally, the benzophenone-based monomer includes at least one of 4-acryloylhydroxybenzoic acid benzophenone and N-(4-benzoylphenyl)-2-acrylamide.

[0021] Optionally, the hydrophilic layer is formed by curing a second solution coated on the transitional base layer;

[0022] The components of the second solution include polyvinyl pyrrolidone, sodium hyaluronate, and a hydrophilic monomer; in parts by weight, polyvinyl pyrrolidone is 5 to 15 parts, sodium hyaluronate is 2 to 9 parts, and the hydrophilic monomer is 8 to 30 parts.

[0023] Optionally, the hydrophilic monomer includes at least one of 3-sulfonate propyl methacrylate potassium salt, 2-methacryloyloxyethyl phosphorylcholine, and methacryloyloxyethyl trimethylammonium chloride.

[0024] Optionally, in step S3, a fluid polishing device is used to perform fluid polishing on the inner surface of the secondary body;

[0025] The abrasive composition used in the fluid polishing operation comprises a first abrasive, a lubricant, and a softener; the weight ratio of the first abrasive, the lubricant, and the softener is (3-6):(1-3):(1-3), the first abrasive comprises silicon carbide, and the particle size of the first abrasive is 200-230 meshes;

[0026] The pressure of the fluid polishing equipment is 60Kgf / cm 2 ~70Kgf / cm 2 ; Polishing time is 20s to 30s; and / or,

[0027] In the step S3, a mirror sandblasting device is first used to clamp one axial end of the secondary blank, and the outer surface of the secondary blank is mirror-blasted and polished for 20s to 30s, and then the mirror sandblasting device is used to clamp the other axial end of the secondary blank, and the outer surface of the secondary blank is mirror-blasted and polished for 20s to 30s;

[0028] The second abrasive used in the mirror sandblasting polishing operation comprises an inner core and a polymer outer coating, wherein the inner core is diamond or silicon carbide, and the polymer outer coating is configured to have elasticity; the particle size of the second abrasive is 0.1 mm to 0.3 mm;

[0029] The sandblasting frequency of the mirror sandblasting polishing equipment is 40 Hz to 50 Hz. To achieve the above object, the present invention also provides a tympanic membrane ventilation and drainage tube, which is manufactured by the manufacturing method of the tympanic membrane ventilation and drainage tube as described in any of the above items.

[0030] Compared with the prior art, the tympanic membrane ventilation drainage tube and the manufacturing method thereof of the present invention have the following advantages:

[0031] The aforementioned tympanic membrane ventilation and drainage tube is manufactured by the following method: a primary metal blank is manufactured by machining; the primary blank has a channel extending through the primary blank along its own axial direction; a polymer coating is provided at least on the wall of the channel of the primary blank to obtain a secondary blank; at least the wall of the channel of the secondary blank is polished to obtain a tympanic membrane ventilation and drainage tube substrate. When the tympanic membrane ventilation and drainage tube is produced by this method, at least the roughness of the wall of the channel of the prepared tympanic membrane ventilation and drainage tube substrate can be reduced to 0.05 μm to 0.1 μm. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The accompanying drawings are used to better understand the present invention and do not constitute an improper limitation of the present invention.

[0033] Figure 1 It is a schematic diagram of the preparation process of a metal tympanic membrane ventilation and drainage tube in the prior art;

[0034] Figure 2 is a flow chart of a method for manufacturing a tympanic membrane ventilation and drainage tube according to one embodiment of the present invention;

[0035] Figure 3 is a flow chart of a method for manufacturing a tympanic membrane ventilation and drainage tube according to another embodiment of the present invention;

[0036] Figure 4 is a schematic diagram of a process of manufacturing a tympanic membrane ventilation and drainage tube according to an embodiment of the present invention;

[0037] Figure 5 yes Figure 4 The enlarged schematic diagram of S in FIG.

[0038] Figure 6 It is a structural schematic diagram of a primary blank of a method for manufacturing a tympanic membrane ventilation and drainage tube according to an embodiment of the present invention;

[0039] Figure 7 is a structural schematic diagram of a primary blank of a method for manufacturing a tympanic membrane ventilation and drainage tube according to another embodiment of the present invention;

[0040] Figure 8 is a schematic structural diagram of a tympanic membrane ventilation and drainage tube substrate and a fixing wire thereon manufactured by a method for manufacturing a tympanic membrane ventilation and drainage tube provided in accordance with another embodiment of the present invention;

[0041] Fig. 9 is a structural schematic diagram of a primary blank of a method for manufacturing a tympanic membrane ventilation and drainage tube according to another embodiment of the present invention;

[0042] Fig.10 is a structural schematic diagram of a primary blank of a method for manufacturing a tympanic membrane ventilation and drainage tube according to yet another embodiment of the present invention;

[0043] Fig.11 The present invention is a schematic structural diagram of a tympanic membrane ventilation and drainage tube substrate and a fixing wire thereon, which is manufactured by a method for manufacturing a tympanic membrane ventilation and drainage tube provided in accordance with another embodiment of the present invention.

[0044] [Description of reference numerals is as follows]:

[0045] 11-blank, 110-first blank, 120-second blank, 12, 130-tympanic membrane ventilation and drainage tube base, 13, 101-channel, 102-polymer coating, 103-connecting hole, 1021-transitional bottom layer, 1022-polymer layer, 111-tube body, 112-first flange, 113-second flange, 114-tip, 200-fixing wire. DETAILED DESCRIPTION

[0046] The following describes the embodiments of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in the present embodiment only illustrate the basic concept of the present invention in a schematic manner, and only the components related to the present invention are shown in the figure instead of being drawn according to the number, shape and size of the components during actual implementation. The type, quantity and proportion of each component during actual implementation can be a random change, and the component layout type may also be more complicated.

[0047] In addition, each embodiment of the following description has one or more technical features, but this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement part or all of the technical features in different embodiments separately. In other words, under the premise that implementation is possible, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present invention and according to the design specifications or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0048] As used in this specification, the singular forms "a", "an", and "the" include plural objects, and the plural form "plurality" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used to include the meaning of "and / or", unless the content clearly indicates otherwise, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be a connection between the internal parts of two elements or an interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0049] The manufacturing process of the metal tympanic membrane ventilation and drainage tube in the prior art includes: firstly, a metal blank 11 (such as Figure 1 A), and then the blank 11 is polished to obtain a tympanic membrane ventilation and drainage tube base 12 (as shown in FIG. Figure 1 (as shown in B)).

[0050] The metal used to manufacture the tympanic membrane ventilation drainage tube is generally titanium or titanium alloy. In the above manufacturing process, due to the high hardness of the metal and the contact between the metal and the cutter head during machining, it is easy to burn due to friction. Therefore, in order to ensure that the formed blank can be obtained, the common machining parameters in the industry are: cutting speed of 100-135m / min, feed rate of 0.10mm / r-0.25mm / r, and cutting depth of 0.15mm-0.25mm. Under this process, the surface roughness of the blank 11 finally obtained is as high as 0.2μm-0.4μm.

[0051] like Figure 1 In figure A), it can be seen that there are obvious knife marks on the surface (including the inner surface and the outer surface) of the blank 11, resulting in protruding burrs and concave pits on the surface of the blank 11, which appears to be in an uneven state. Polishing is a processing technology that uses polishing particles to grind and remove materials. It can remove protruding burrs on the surface of the blank 11, but it is difficult to completely grind the pits on the surface of the blank 11. The pits may even be further ground by the polishing particles. The degree of depression of the pits may even increase. Therefore, the direct polishing process can be used to remove larger protruding burrs on the surface of the blank, and there will be a certain degree of improvement in improving the surface roughness of the blank 11, but it is still not thorough, that is, the surface of the tympanic membrane ventilation and drainage tube base 12 is still uneven (such as Figure 1 Generally, the surface roughness of the tympanic membrane ventilation and drainage tube substrate 12 is not less than 0.15 μm, and the contact angle exhibited by the substrate surface tends to decrease.

[0052] When the tympanic membrane ventilation and drainage tube including the tympanic membrane ventilation and drainage tube base 12 is used to treat secretory otitis media or Eustachian tube dysfunction, fluid accumulation, blood clot absorption, and tube blockage may easily occur after the tube is placed due to the rough wall of the channel 13 of the tympanic membrane ventilation and drainage tube base 12.

[0053] In view of this, an embodiment of the present invention provides a method for manufacturing a tympanic membrane ventilation and drainage tube to further reduce the surface roughness of the manufactured tympanic membrane ventilation and drainage tube substrate, so that when the tympanic membrane ventilation and drainage tube is used for the treatment of secretory otitis media or Eustachian tube dysfunction, the problem of tube blockage caused by effusion and blood clot adsorption due to the roughness of the lumen of the tympanic membrane ventilation and drainage tube can be effectively reduced.

[0054] In order to make the purpose, advantages and features of the present invention more clear, the present invention is further described in detail below with reference to the accompanying drawings. It should be noted that the drawings are all in very simplified form and in non-precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar components.

[0055] Figure 2 The method for manufacturing the tympanic membrane ventilation and drainage tube provided by the embodiment of the present invention is shown. Figure 2 As shown, the manufacturing method comprises:

[0056] Step S1: machining to produce Figure 4 The primary body 110 of metal shown in a) has a channel 101 extending through it in its axial direction.

[0057] Step S2: Provide a polymer coating 102 at least on the wall of the channel 101 of the primary body 110 to obtain Figure 4 b) shows the secondary body 120. It can be understood that after this step is completed, the channel 101 still exists, but the inner diameter of the channel 101 is reduced due to the setting of the polymer coating 102.

[0058] Step S3: polishing the wall of the channel 101 of the secondary body 120 to obtain Figure 4 The tympanic membrane ventilation drainage tube base 130 is shown in c).

[0059] In some examples, after step S3 is completed, no further treatment is performed on the surface of the tympanic membrane ventilation and drainage tube substrate 130. In other examples, after step S3 is completed, step S4 is further performed, and step S4 includes: providing a drug coating (not shown in the figure) on at least a portion of the surface of the tympanic membrane ventilation and drainage tube substrate 130, so that the tympanic membrane ventilation and drainage tube includes the tympanic membrane ventilation and drainage tube substrate 130 and the drug coating provided on the surface thereof.

[0060] In the above process, there are uneven knife marks on the inner and outer surfaces of the primary blank 110. By setting the polymer coating 102, the concave and convex positions on the wall of the channel 101 of the primary blank 110 can be filled, so that the wall of the channel 101 of the secondary blank 120 becomes smoother. On this basis, when polishing is performed to further improve the smoothness of the wall of the channel 101, the smoothness of the wall of the channel 101 of the obtained tympanic membrane ventilation and drainage tube substrate 130 can be significantly improved. In practice, by executing the above method, the roughness of the wall of the channel 101 of the obtained tympanic membrane ventilation and drainage tube substrate 130 can be reduced to less than 0.1 μm, specifically between 0.05 μm and 0.1 μm. At the same time, the smaller the roughness of the wall of the channel 101, when it reaches the level of a mirror surface, the wall of the channel 101 can also show a lower contact angle, so that the hydrophilicity of the wall of the channel 101 is better.

[0061] It can be understood that even if the drug coating is provided on the surface of the tympanic membrane ventilation and drainage tube substrate 130 , the surface roughness of the drug coating located at the channel 101 is relatively small.

[0062] In this way, when the tympanic membrane ventilation and drainage tube including the tympanic membrane ventilation and drainage tube base 130 is used to treat secretory otitis media or Eustachian tube dysfunction, the phenomenon of fluid accumulation and blood clot absorption caused by the roughness of the wall of the channel 101 can be reduced or even avoided, thereby avoiding the problem of tube blockage caused by fluid accumulation and blood clot absorption.

[0063] Preferably, the step S2 further comprises providing the polymer coating 102 on other surfaces of the primary body 110 except the wall of the channel 101. The step S3 further comprises polishing other surfaces of the secondary body 120 except the wall of the channel 101. It can be understood that the wall of the channel 101 of the primary body 110 is at least a part of the inner surface of the primary body 110.

[0064] In other words, the step S2 includes providing the polymer coating 102 on all surfaces of the primary body 110, and the step S3 includes polishing all surfaces of the secondary body 120 (e.g., Figure 3As shown). It can be understood that all surfaces here include all inner surfaces and all outer surfaces. In this way, all surfaces of the tympanic membrane ventilation and drainage tube substrate 130 can have a relatively small surface roughness. On the one hand, the advantage of doing so is that it can also reduce the problem of the tympanic membrane ventilation and drainage tube having effusion or blood scab adsorbed on other surfaces of the tympanic membrane ventilation and drainage tube except the wall of the channel 101 during the use process. On the other hand, the advantage is that when setting the polymer coating 102, there is no need to avoid other surfaces except the wall of the channel 101 of the primary blank 110, and the operation is easier.

[0065] In addition, in some embodiments, the primary substrate 110 is further provided with a connection hole 103 (such as Figure 7 and Fig.10 As shown in FIG. 1 ), the tympanic membrane ventilation and drainage tube base 130 obtained in step S3 also has the connection hole 103. In this case, the manufacturing method may further include step S5, wherein the step S5 includes setting a fixing wire 200 (as shown in FIG. 1 ) on the tympanic membrane ventilation and drainage tube base 130 through the connection hole 103. Figure 8 and Fig.11 As shown), the material of the fixing die 200 is, for example, metal, specifically, the same metal as the material of the primary blank 110.

[0066] It should be noted that after the step S3 is completed, the polymer coating 102 is preferably completely removed.

[0067] Next, each step of the manufacturing method is further described in detail. It should be noted that the following description is based on the example of setting the polymer coating 102 on the entire surface of the primary body 110 and polishing the entire surface of the secondary body 120, but it should not constitute an improper limitation on the present invention. Those skilled in the art can modify the following description to adapt to the situation where the polymer coating 102 is only set on the wall of the channel 101 of the primary body 110, and only the wall of the channel 101 of the secondary body 120 is polished.

[0068] The step S1 can be performed with reference to the prior art and will not be described in detail here.

[0069] The embodiment of the present invention has no particular limitation on the structure of the primary blank 110, which may have any suitable structure. Figure 6 As shown, the primary blank 110 in some embodiments includes a tube body 111, a first flange 112 and a second flange, the tube cavity of the tube body 111 constitutes the channel 101, and the first flange 112 and the second flange 113 are respectively arranged at the axial ends of the tube body 111. Figure 7 As shown, it is Figure 6 The difference between the primary blank 110 in the embodiment is that the first flange 112 is provided with the connecting hole 103, and the connecting hole 103 is used to pass the fixing wire 200 (such as Figure 8 In some other examples, the structure of the primary blank 110 is as follows: Fig. 9 As shown, it is Figure 6 The difference of the primary blank 110 shown is that a tip 114 is formed on the first flange 112, and the tip 114 can replace the myringotomy instrument to form an incision on the tympanic membrane during the tube placement process. Fig.10 As shown, Fig.10 The primary blank 110 shown in FIG. Fig. 9 The difference between the primary blank 110 shown in the figure is that the first flange 112 is also formed with a thread for passing the fixing wire 200 (such as Fig.11 As shown) the connecting hole 103.

[0070] In addition, the diameter of the channel 101 in the primary blank 110 may be 0.7 mm to 1.6 mm, and the outer diameters of the first flange 112 and the second flange 113 may be 2.0 mm to 2.85 mm.

[0071] The step S2 specifically includes:

[0072] Step S21, providing the transitional bottom layer 1021 (such as Figure 5 shown).

[0073] Step S22: arranging the hydrophilic layer 1022 (such as Figure 5 shown).

[0074] That is, the polymer coating 102 includes a hydrophilic layer 1022 and a transitional bottom layer 1021 located between the metal surface of the primary body 110 and the hydrophilic layer 1022. The transitional bottom layer 1021 can be firmly adhered to the metal surface of the primary body 110, and the transitional bottom layer 1021 can also be firmly adhered to the hydrophilic layer 1022, so that the polymer coating 102 is stably attached to the metal surface of the primary body 110, is not easy to peel off, and improves the uniformity of the polymer coating 102.

[0075] The transitional bottom layer 1021 is formed by curing a first solution coated on the surface of the primary body 110. The first solution comprises benzophenone-based monomer, acrylic acid and solvent, and in the first solution, the mass ratio of benzophenone-based monomer, acrylic acid and solvent is (3-18): (86-95):100.

[0076] Wherein, the benzophenone-based monomer includes but is not limited to at least one of 4-acryloylhydroxybenzoic acid benzophenone and N-(4-benzoylphenyl)-2-acrylamide.

[0077] In a non-limiting example, the specific process of forming the transitional bottom layer 1021 may be to first apply the first solution to the surface of the primary body 110 by dip coating, and then solidify the first solution applied on the surface of the primary body 110 by any appropriate method.

[0078] When the primary body 110 is dipped in the first solution, the primary body 110 is immersed in the first solution at a speed of 20 mm / min to 40 mm / min, the dwell time is 5 s to 15 s, and the pulling speed is 10 mm / min to 15 mm / min. The thickness of the transitional bottom layer 1021 formed by curing is 15 μm to 60 μm.

[0079] The hydrophilic layer 1022 is formed by curing the second solution coated on the transitional bottom layer 1021. The second solution comprises polyvinyl pyrrolidone, sodium hyaluronate, and a hydrophilic monomer, and in parts by weight, the polyvinyl pyrrolidone is 5 to 15 parts, the sodium hyaluronate is 2 to 9 parts, and the hydrophilic monomer is 8 to 30 parts.

[0080] The hydrophilic monomer includes at least one of 3-sulfonate propyl methacrylate potassium salt, 2-methacryloyloxyethyl phosphorylcholine, and methacryloyloxyethyl trimethylammonium chloride.

[0081] In a non-limiting example, the specific process of forming the hydrophilic layer 1022 is: firstly, the second solution is coated on the surface of the transitional bottom layer 1021 by dip coating, and then the second solution coated on the surface of the transitional bottom layer 1021 is cured by any suitable method.

[0082] When the primary body 110 provided with the transitional bottom layer 1021 is dipped in the second solution, the primary body 110 provided with the transitional bottom layer 1021 is dipped in the second solution at a speed of 30 mm / min to 50 mm / min, a residence time of 5 s to 15 s, and a pulling speed of 20 mm / min to 30 mm / min. The thickness of the transitional bottom layer 1021 formed by curing is 3 μm to 5 μm.

[0083] like Figure 3 As shown, in step S3, the polishing of the inner surface and the outer surface of the secondary body 120 are performed separately, that is, step S3 includes step S31 and step S32, step S31 includes polishing the outer surface of the secondary body 120, and step S32 includes polishing the inner surface of the secondary body 120. Wherein, step S31 can be performed in any suitable manner, and step S32 is preferably performed by a fluid polishing process (also referred to as an abrasive flow polishing process).

[0084] The fluid polishing process can be either a unidirectional polishing process or a bidirectional reciprocating polishing process. Those skilled in the art know that the fluid polishing process is a process that uses polishing equipment to make an abrasive composition in a fluid state flow out from the inner cavity channel of the product, and repeatedly squeezes into and grinds the channel during the outflow process to remove scratches, burrs and other defects. In an embodiment of the present invention, the optional abrasive composition is prepared from a first abrasive, a lubricant, and a softener in a preset ratio, and the preset ratio is ((3~6):((1~3):~((1~3). The first abrasive includes silicon carbide, and the particle size of the first abrasive is 200 mesh to 230 mesh. The abrasive composition has a good contact effect with the hydrophilic layer 1022, and the abrasive composition will not adhere to the hydrophilic layer, so that the wall of the channel 101 can be polished well.

[0085] It should be noted that the fluid polishing operation in the embodiment of the present invention can be performed using any fluid polishing equipment in the prior art. The specific process is: first, the fixed fixture is installed on the flange surface of the abrasive cylinder, then the secondary blank 120 is installed on the fixed fixture, and then the fluid polishing equipment is started to start polishing. It can be understood that during the polishing process, the upper and lower cylinders of the fluid polishing equipment move and squeeze the abrasive composition, so that the abrasive composition flows through the inner surface of the secondary blank 110. During polishing, the pressure of the fluid polishing equipment is 60Kgf / cm 2 ~70Kgf / cm 2 The polishing time is 20s to 30s.

[0086] In step S3, the outer surface of the secondary blank 120 is polished by using a mirror blasting process. The abrasive used in the mirror blasting process is called a second abrasive, and the second abrasive includes an inner core and a polymer outer coating layer, the inner core is diamond or silicon carbide, and the polymer outer coating layer has a certain elasticity. The particle size of the second abrasive is 0.1 mm to 0.3 mm.

[0087] The mirror sandblasting and polishing operation in the embodiment of the present invention can be performed by any mirror sandblasting and polishing equipment in the prior art. The specific process is: first, one axial end of the secondary blank 120 is connected to the fixture, and then the fixture is placed on the workstation corresponding to the rotating disk, and then the mirror sandblasting and polishing equipment is started to start polishing the secondary blank 120, and the polishing time is 20s to 30s; then the mirror sandblasting equipment is stopped, and then the secondary blank 120 is removed from the fixture and the orientation of the secondary blank 120 is adjusted, and then the other axial end of the secondary blank 120 is connected to the fixture, and the fixture is placed on the workstation corresponding to the rotating disk, and then the mirror sandblasting and polishing equipment is started to start polishing the secondary blank 120, and the polishing time is also 20s to 30s. In the above process, the sandblasting frequency of the mirror sandblasting equipment is 40Hz to 50Hz.

[0088] It should be understood that when polishing the secondary body 120, the outer surface of the secondary body 120 may be firstly subjected to fluid polishing, and then the inner surface of the secondary body 120 may be subjected to mirror blasting polishing (i.e., Figure 3 The order shown in the figure) can also be that the inner surface of the secondary body 120 is first subjected to a mirror-like sandblasting polishing operation, and then the outer surface of the secondary body 120 is subjected to a fluid polishing operation (not shown in the figure).

[0089] The drug coating in step S4 is formed by solidifying the third solution coated on the surface of the tympanic membrane ventilation and drainage tube substrate 130. The third solution includes drugs, and the optional drugs are, for example, anticoagulants and / or anti-inflammatory drugs. The anticoagulants include, but are not limited to, at least one of heparin and warfarin, and the anti-inflammatory drugs include, but are not limited to, at least one of dexamethasone, amoxicillin-clavulanate potassium, levofloxacin and its derivatives. In addition, the third solution may also include a polymer to play an adhesion effect.

[0090] Optionally, the third solution is coated on the surface of the tympanic membrane ventilation and drainage tube substrate 130 by dip coating. During dip coating, the tympanic membrane ventilation and drainage tube substrate 130 is immersed in the third solution at a speed of 10 mm / min to 30 mm / min, the residence time is 20 s to 40 s, and the pulling speed is 5 mm / min to 15 mm / min. After dip coating, the third solution coated on the tympanic membrane ventilation and drainage tube substrate 130 can be solidified by standing for 200 s to 300 s or by hot air blowing or any other suitable method. The thickness of the drug coating formed after solidification can be between 5 μm and 16 μm.

[0091] A second purpose of the embodiment of the present invention is to provide a tympanic membrane ventilation and drainage tube manufactured by the aforementioned manufacturing method.

[0092] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A method for manufacturing a tympanic membrane ventilation and drainage tube, characterized in that: include: Step S1, manufacturing a primary blank of metal by machining; the primary blank has a channel extending through it along its own axial direction; Step S2, providing a polymer coating at least on the wall of the channel of the primary body to obtain a secondary body; Step S3, polishing at least the wall of the channel of the secondary blank to obtain a tympanic membrane ventilation and drainage tube base.

2. The method for manufacturing a tympanic membrane ventilation and drainage tube according to claim 1, characterized in that: The step S2 further comprises providing the polymer coating on the other surfaces of the primary body except the wall of the channel; the step S3 further comprises polishing the other surfaces of the secondary body except the wall of the channel; and / or, The manufacturing method further comprises: Step S4, providing a drug coating on at least a portion of the surface of the tympanic membrane ventilation and drainage tube substrate.

3. The method for manufacturing a tympanic membrane ventilation and drainage tube according to claim 1, characterized in that: The step S2 comprises: Step S21, providing a transitional bottom layer at least on the wall of the channel of the primary body; Step S22, providing a hydrophilic layer on the transitional bottom layer; The step S3 includes polishing the wall of the channel of the secondary body by using a fluid polishing process.

4. The method for manufacturing a tympanic membrane ventilation and drainage tube according to claim 3, characterized in that: The thickness of the transitional bottom layer is 15 μm to 60 μm, and the thickness of the hydrophilic layer is 3 μm to 5 μm.

5. The method for manufacturing a tympanic membrane ventilation and drainage tube according to claim 3, characterized in that: The transitional bottom layer is formed by solidifying the first solution coated at least on the wall of the channel of the primary body; The components of the first solution include benzophenone-based monomer, acrylic acid, and solvent; and in the first solution, the mass ratio of benzophenone-based monomer, acrylic acid, and solvent is (3-18):(86-95):

100.

6. The method for manufacturing a tympanic membrane ventilation and drainage tube according to claim 5, characterized in that: The benzophenone-based monomer includes at least one of 4-acryloylhydroxybenzoic acid benzophenone and N-(4-benzoylphenyl)-2-acrylamide.

7. The method for manufacturing a tympanic membrane ventilation and drainage tube according to claim 3, characterized in that: The hydrophilic layer is formed by curing the second solution coated on the transitional base layer; The components of the second solution include polyvinyl pyrrolidone, sodium hyaluronate, and a hydrophilic monomer; in parts by weight, polyvinyl pyrrolidone is 5 to 15 parts, sodium hyaluronate is 2 to 9 parts, and the hydrophilic monomer is 8 to 30 parts.

8. The method for manufacturing a tympanic membrane ventilation and drainage tube according to claim 7, characterized in that: The hydrophilic monomer includes at least one of 3-sulfonate propyl methacrylate potassium salt, 2-methacryloyloxyethyl phosphorylcholine, and methacryloyloxyethyl trimethylammonium chloride.

9. The method for manufacturing a tympanic membrane ventilation and drainage tube according to claim 2, characterized in that: In the step S3, a fluid polishing device is used to perform fluid polishing on the inner surface of the secondary body; The abrasive composition used in the fluid polishing operation comprises a first abrasive, a lubricant, and a softener; the weight ratio of the first abrasive, the lubricant, and the softener is (3-6):(1-3):(1-3), the first abrasive comprises silicon carbide, and the particle size of the first abrasive is 200-230 meshes; The pressure of the fluid polishing equipment is 60Kgf / cm 2 ~70Kgf / cm 2 ; Polishing time is 20s to 30s; and / or, In the step S3, a mirror sandblasting device is first used to clamp one axial end of the secondary blank, and the outer surface of the secondary blank is mirror-blasted and polished for 20s to 30s, and then the mirror sandblasting device is used to clamp the other axial end of the secondary blank, and the outer surface of the secondary blank is mirror-blasted and polished for 20s to 30s; The second abrasive used in the mirror sandblasting polishing operation comprises an inner core and a polymer outer coating, wherein the inner core is diamond or silicon carbide, and the polymer outer coating is configured to have elasticity; the particle size of the second abrasive is 0.1 mm to 0.3 mm; The sandblasting frequency of the mirror sandblasting and polishing equipment is 40 Hz to 50 Hz.

10. A tympanic membrane ventilation and drainage tube, characterized in that: The tympanic membrane ventilation and drainage tube is manufactured by the manufacturing method of the tympanic membrane ventilation and drainage tube according to any one of claims 1 to 9.

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