Method for enhancing the fixation stability of an artificial ossicle prosthesis, prosthesis and use

Abstract

The present application relates to the technical field of artificial implant medical device surface modification and middle ear hearing reconstruction, and discloses a processing method for enhancing the fixing stability of an artificial auditory ossicle prosthesis, the prosthesis and application. The method comprises the following steps: after the surface of the auditory ossicle prosthesis in contact with the middle ear tissue is cleaned, a polydopamine layer is formed in a basic dopamine solution, then gelatin, hyaluronic acid or cellulose sulfate is connected to the surface of the polydopamine layer through a carbodiimide activation system to form a viscous functional layer, and the dry sponge-like structure is obtained through freeze-drying. The functional layer can quickly rehydrate and restore the adhesion state after contacting with human blood or tissue fluid, thereby improving the fixing stability of the artificial auditory ossicle prosthesis in the initial implantation stage and reducing the risk of displacement or dislocation.

Description

Technical Field

[0001] This invention relates to the field of surface modification of implantable medical devices and middle ear hearing reconstruction technology, specifically to a method for enhancing the fixation stability of artificial ossicle prostheses, artificial ossicle prostheses obtained by the method, and their applications. Background Technology

[0002] Diseases of the ossicular chain in the middle ear can lead to conductive hearing loss. To address this issue, most patients can undergo surgical reconstruction of the ossicular chain to restore hearing. Currently, there are three main types of ossicular prostheses commonly used: total implantable ossicular prostheses (TORP), partial implantable ossicular prostheses (PORP), and stapes prostheses (PISTON), used to treat conductive hearing loss caused by lesions in different parts of the ossicular chain. Among them, TORP... Figure 1 As shown, it mainly connects the tympanic membrane or mallet footplate to the stapes footplate. Some doctors add cartilage between the tympanic membrane and the TORP baseplate to fix the prosthesis; PORP, made of Figure 2 As shown, the main component connects the tympanic membrane or mallet arm to the stapes head. The prosthesis has cup-shaped or claw-shaped structures that are fixed by clamping with the stapes head. Some doctors will add cartilage between the tympanic membrane and the PORP base plate to fix the prosthesis. The PISTON has a hook that clamps the incus arm, and the other end extends into the inner ear from the stapes footplate.

[0003] However, the outcomes of such reconstructions vary considerably. Differences in postoperative hearing loss are often associated with poor coupling between the ossicular prosthesis and the tympanic membrane (TM) or inner ear. According to reports, between 2010 and 2020, displacement failure modes of ossicular prostheses (primarily total implantable ossicular prostheses (TORPs) and partial implantable ossicular prostheses (PORPs)) accounted for 27% of device-related failures in the FDA's MAUDE database. Similar issues exist with stapes reconstruction, where stapes prosthesis (PISTON) dislodgement has become a significant cause of stapes reconstruction failure in patients.

[0004] Currently, commercially available ossicular prostheses rely solely on the tension and mechanical clamping between the prosthesis and the middle ear structure for fixation. Since the tympanic membrane is only about 0.1mm thick, the base plate in contact with it is mostly planar, relying on the prosthesis's own tension for fixation. However, excessive tension can easily damage the tympanic membrane and affect the sound conduction performance after ossicular chain reconstruction. Insufficient tension may lead to prosthesis dislodgement and also affect sound conduction performance. This presents a significant challenge for clinicians during prosthesis implantation. Furthermore, initial tympanic membrane vibration or minor movements of the middle ear tissue can easily cause prosthesis displacement or dislodgement, potentially leading to ear inflammation or a second surgery.

[0005] Patent CN114949355B describes a method of first preparing a micro-nano porous titanium coating on the surface of a 3D-printed titanium ossicle frame, followed by cold spraying of a polyvinyl alcohol (PVA) film to achieve "ossicle-cartilage integration," reducing prosthesis displacement and improving coupling. This patent uses a physical interlocking method to spray the polyethylene film onto the prosthesis base, improving the surface characteristics of the base to increase the hardness of the contact surface with the tympanic membrane and reduce the risk of tympanic membrane rupture. However, the coupling between the prosthesis and the tympanic membrane still relies on physical contact, and it does not solve the problem of prosthesis dislodgement due to misalignment in the early stages of implantation. Summary of the Invention

[0006] This invention aims to provide a method, prosthesis, and application for enhancing the fixation stability of artificial ossicles, addressing the problems of existing artificial ossicle prostheses relying primarily on mechanical overlap or support for initial fixation in the moist environment of the middle ear, and being prone to displacement, dislocation, or unstable fixation due to tissue fluid wetting, local micromovement, or intraoperative disturbance. To address this, this invention functionalizes the surface of the artificial ossicle prosthesis in contact with the middle ear tissue, first forming a polydopamine layer, and then further constructing an adhesive functional layer capable of rehydrating and restoring adhesion upon contact with human blood or tissue fluid. This improves the fixation stability of the artificial ossicle prosthesis in the initial stage of implantation and provides favorable conditions for subsequent tissue adhesion and stable reconstruction.

[0007] According to a first aspect of the present invention, a method for enhancing the fixation stability of an artificial ossicle prosthesis is provided, comprising the following steps: Surface cleaning of the artificial ossicle prosthesis; The surface of the artificial ossicle prosthesis that contacts the middle ear tissue is placed in an alkaline dopamine solution for surface modification to form a polydopamine layer on the surface. The surface on which the polydopamine layer is formed is then placed in a reaction solution containing a carbodiimide activation system and reactants to react, so that the reactants are attached to the surface of the polydopamine layer and form an adhesive functional layer. The artificial ossicle prosthesis with the adhesive functional layer formed thereon is cleaned and dried to obtain the processed artificial ossicle prosthesis; The adhesive functional layer can rehydrate and restore its adhesive state after contact with human blood or tissue fluid, thereby improving the fixation stability of the artificial ossicle prosthesis in the early stage of implantation.

[0008] In some technical solutions, the artificial ossicle prosthesis is one of a fully implanted ossicle prosthesis, a partially implanted ossicle prosthesis, or a stapes prosthesis; Wherein, when the artificial ossicle prosthesis is a fully implanted ossicle prosthesis or a partially implanted ossicle prosthesis, the surface in contact with the middle ear tissue is the base surface in contact with the tympanic membrane; when the artificial ossicle prosthesis is a stapes prosthesis, the surface in contact with the middle ear tissue is the hook surface in contact with the middle ear tissue.

[0009] In some technical solutions, the alkaline dopamine solution is a dopamine hydrochloride solution prepared with a buffer solution with a pH of 8 to 9, wherein the buffer solution is one or more of phosphate buffer, Tris buffer, or bicarbonate buffer, and the concentration of the dopamine hydrochloride solution is 1 to 3 mg / mL.

[0010] In some technical solutions, the surface modification conditions include: a reaction temperature of 37°C and a reaction time of 24 to 48 hours.

[0011] In some technical solutions, the carbodiimide activation system includes EDC and NHS, and the reaction solution also includes MES buffer. Preferably, the concentration of the MES buffer is 0.05 to 0.1 M, the concentration of the EDC is 0.1 to 0.4 M, the concentration of the NHS is 0.05 to 0.2 M, and the pH of the reaction solution is 5 to 6.

[0012] In some technical solutions, the reactants are one or more of gelatin, hyaluronic acid, or cellulose sulfate, the mass concentration of the reactants in the reaction solution is 1% to 5%, and the reaction time is 12 to 24 hours.

[0013] In some technical solutions, the drying is freeze-drying, which includes: placing the cleaned artificial ossicle prosthesis under vacuum freeze-drying at -50℃ for 12 hours, and then keeping it at 20℃ for 2 hours; Preferably, the process further includes packaging and sterilization steps after drying, wherein the packaging is blister packaging and the sterilization is gamma irradiation sterilization or ethylene oxide sterilization.

[0014] In some technical solutions, the surface cleaning includes: sequentially using isopropanol, ethanol and purified water to perform ultrasonic cleaning on the artificial ossicle prosthesis.

[0015] According to a second aspect of the present invention, an artificial ossicle prosthesis is provided, comprising a metal prosthesis body and an adhesive functional layer disposed on the contact surface between the metal prosthesis body and the middle ear tissue. The adhesive functional layer includes a polydopamine layer located on the surface of the metal prosthesis body and a functional polymer layer attached to the surface of the polydopamine layer. The functional polymer layer has a sponge-like structure in the dry state. After contact with human blood or tissue fluid, it can rehydrate and restore its adhesive state, thereby improving the fixation stability of the artificial ossicle prosthesis in the early stage of implantation. The metal prosthesis body is made of pure titanium, nickel-titanium, or titanium alloy. The functional polymer in the functional polymer layer is one or more of gelatin, hyaluronic acid, or cellulose sulfate. The artificial ossicle prosthesis is a fully implanted ossicle prosthesis, a partially implanted ossicle prosthesis, or a stapes prosthesis. The adhesive functional layer is disposed on the base surface of the fully implanted ossicle prosthesis or the partially implanted ossicle prosthesis, or on the hook surface of the stapes prosthesis.

[0016] According to a third aspect of the invention, the above-described artificial ossicle prosthesis is further provided for use in the preparation of implantable devices for ossicular chain reconstruction.

[0017] The present invention, by employing the above technical solution, has at least the following beneficial effects: 1. This invention treats the surface of the artificial ossicle prosthesis that contacts the middle ear tissue by first forming a polydopamine layer, and then attaching a functional polymer layer to the polydopamine layer. This creates a viscous functional layer that can rehydrate and regain its adhesive state after contact with human blood or tissue fluid. The mechanism of action is that the polydopamine layer, through its surface-active groups, enhances the reactivity and interfacial bonding ability of the metal prosthesis surface, providing a foundation for the stable connection of the subsequent functional polymer layer. The functional polymer layer, in its dry state, forms a relatively loose structure, which can rapidly absorb and rehydrate upon contact with blood or tissue fluid, releasing strong interfacial wetting and adhesive capabilities. This creates additional interfacial adhesion between the prosthesis and the tympanic membrane or related middle ear tissues. Based on this effect, initial fixation is no longer achieved solely through traditional mechanical splicing, support, or clamping. Instead, the synergistic effect of surface adhesion and structural fit enhances the initial fixation stability of the artificial ossicle prosthesis, reducing the risk of displacement, dislocation, and unstable fit after intraoperative adjustments or in the early postoperative period.

[0018] 2. In this invention, the polydopamine layer is disposed between the metal prosthesis body and the functional polymer layer, serving as an interface transition and enhancing bonding. Specifically, the polydopamine layer can firmly adhere to the surface of metal substrates such as pure titanium, nickel-titanium, or titanium alloys, and can also connect with subsequent reactants, thereby ensuring the stable retention of the functional polymer layer on the prosthesis surface. This avoids the problems of weak bonding, easy detachment, or insufficient stability after treatment that often occur when simply attaching hydrophilic polymers or adhesive materials directly to the metal surface, improving the retention and reliability of the adhesive functional layer during preparation, cleaning, drying, and actual implantation.

[0019] 3. The adhesive functional layer formed in this invention is easy to prepare, store, sterilize and package in a dry state, and can be rehydrated and restored to an adhesive state under the action of blood or tissue fluid when implanted. Therefore, it takes into account both the stability of the product in the early storage and the interfacial adhesion performance during clinical use, which is beneficial to improving the operability of artificial ossicle prostheses in preparation, transportation and clinical application.

[0020] 4. This invention is applicable to different types of artificial ossicle prostheses, such as fully implanted ossicle prostheses, partially implanted ossicle prostheses, and stapes prostheses. It can also place the adhesive functional layer on the surface of the base plate or the hook surface, or other areas in contact with the middle ear tissue, according to different structural characteristics. Therefore, it has good applicability and versatility and can meet the needs of improving the initial fixation stability in different ossicular chain reconstruction scenarios. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings and their markings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the structure of the fully implantable ossicular prosthesis (TORP) described in the background art; Figure 2 This is a schematic diagram of the partially implanted ossicular prosthesis (PORP) described in the background art; Figure 3 This is a schematic diagram illustrating the principle of fixed stability testing in a specific embodiment of the present invention.

[0023] The meanings of the symbols in the diagram are as follows: 3—weights, 41—tympanic membrane simulator, 42—staped footplate simulator. Detailed Implementation

[0024] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Experimental methods in the following embodiments, unless otherwise specified, are generally performed under conventional conditions or as recommended by the manufacturer. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those familiar to those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to the methods of the present invention. The preferred embodiments and materials described herein are for illustrative purposes only.

[0025] This embodiment provides a method for enhancing the fixation stability of artificial ossicle prostheses, applicable to the surface functionalization of fully implanted, partially implanted, and stapes prostheses. The artificial ossicle prosthesis can be made of metals such as pure titanium, nickel-titanium, or titanium alloys. After implantation in the middle ear, the artificial ossicle prosthesis achieves sound conduction through physical contact with the tympanic membrane, residual ossicles, or other middle ear tissues. Due to the moist environment of the middle ear and the fact that the prosthesis has not yet formed a stable bond with the surrounding tissues in the early stages of implantation, the prosthesis is prone to unstable contact, insufficient adhesion, or even displacement or dislocation after intraoperative adjustments or in the early postoperative period due to local micromovements, body fluid wetting, or external disturbances. This embodiment improves the fixation stability in the early stages of implantation by constructing a rehydrated functional layer on the surface of the prosthesis in contact with the middle ear tissues.

[0026] Specifically, in this embodiment, a TORP or PORP ossicular prosthesis is selected as the treatment object, and the base portion that contacts the tympanic membrane is used as the surface treatment area. First, the ossicular prosthesis is surface-cleaned. The ossicular prosthesis is sequentially immersed in isopropanol, ethanol, and purified water, and then ultrasonically treated for 10-30 minutes each to thoroughly remove any oil, processing residues, and other impurities that may be present on the prosthesis surface.

[0027] After surface cleaning, prepare an alkaline dopamine hydrochloride solution. Specifically, prepare a 1-3 mg / mL dopamine hydrochloride solution using a buffer solution, which can be one of phosphate buffer, Tris buffer, or bicarbonate buffer, or a combination of two or more, and adjust the pH of the solution to 8-9. Immerse the base portion of the TORP or PORP prosthesis that contacts the tympanic membrane in the above alkaline dopamine hydrochloride solution and react at a constant temperature of 37°C for 24-48 h. After the reaction is complete, remove the prosthesis and rinse with purified water to remove any unreacted residues.

[0028] In this step, dopamine undergoes an oxidative self-polymerization reaction under alkaline conditions, gradually depositing a polydopamine layer on the surface of the metal prosthesis. This polydopamine layer adheres firmly to the surface of metal substrates such as pure titanium, nickel-titanium, or titanium alloys, thus forming a stable interfacial transition layer on the prosthesis surface. On one hand, this polydopamine layer improves the interfacial activity of the metal prosthesis surface; on the other hand, the active groups on its surface provide reaction sites for the subsequent connection of functional polymer layers, thereby laying the foundation for constructing a stable, viscous functional layer.

[0029] Subsequently, the prosthesis with the polydopamine layer formed undergoes a functional polymer layer bonding process. Specifically, a 2-morpholinoethanesulfonic acid (MES) buffer solution is prepared using purified water, with a concentration of 0.05-0.1 M. 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide (EDC) and N-hydroxysuccinimide (NHS) are added to this buffer, with EDC concentrations of 0.1-0.4 M and NHS concentrations of 0.05-0.2 M. After thorough mixing, the pH of the system is adjusted to 5-6. Then, reactants are added to the system and allowed to dissolve completely. These reactants can be one or more of gelatin, hyaluronic acid, and cellulose sulfate, with a mass concentration of 1%-5%. The TORP or PORP prosthesis base plate with the polydopamine layer formed is immersed in the above reaction solution and reacted for 12-24 hours. After the reaction is complete, the prosthesis is removed and rinsed thoroughly with purified water.

[0030] In this step, the carbodiimide activation system composed of EDC and NHS activates the carboxyl groups in the reactants, causing them to react with the amino groups on the surface of the polydopamine layer and form amide bonds. This stably links functional polymers such as gelatin, hyaluronic acid, or cellulose sulfate to the surface of the polydopamine layer, thus forming an adhesive functional layer in the prosthesis treatment area. This functional layer is not a simple physical adhesion, but rather achieves a relatively stable bond with the surface of the metal prosthesis through interfacial chemical bonding, thus exhibiting good adhesion stability and treatment reliability. Simultaneously, materials such as gelatin, hyaluronic acid, and cellulose sulfate themselves possess good hydrophilicity and biocompatibility, allowing them to quickly absorb water and regain a moist and soft state upon subsequent contact with bodily fluids, thereby improving the fit between the prosthesis and surrounding tissues.

[0031] After the formation of the adhesive functional layer, the reacted ossicular prosthesis was rinsed with purified water and freeze-dried under vacuum at -50°C for 12 hours, followed by incubation at 20°C for 2 hours before removal. Following this freeze-drying process, the functional polymer layer attached to the prosthesis surface forms a relatively uniform sponge-like structure. This sponge-like structure facilitates subsequent product storage, packaging, and transportation. Furthermore, during actual implantation, it can rapidly absorb liquid and rehydrate upon contact with human blood or tissue fluid, restoring its gel-like state and interfacial adhesion properties. Therefore, the prosthesis receives additional fixation from the adhesive functional layer from the initial implantation stage.

[0032] Finally, the processed ossicular prostheses are packaged in blister packs and sterilized by gamma irradiation or ethylene oxide to obtain the finished product. The resulting artificial ossicular prostheses can be kept dry when not in use, facilitating storage after sterilization and clinical retrieval. After implantation in the middle ear and contact with human blood or tissue fluid, the spongy functional layer on its surface can quickly rehydrate and return to a gel state, thereby enhancing the interfacial contact and adhesion between the prosthesis and the tympanic membrane or other middle ear tissues.

[0033] To better understand and apply the above solutions and to effectively demonstrate their corresponding benefits, the following describes in conjunction with specific embodiments a method for enhancing the fixation stability of artificial ossicle prostheses, the prosthesis itself, and its applications provided by the present invention.

[0034] Example 1 1. Soak the TORP prosthesis in isopropanol, ethanol, and purified water, and sonicate for 30 minutes each.

[0035] 2. Prepare a 1 mg / ml dopamine hydrochloride solution with pH 8.5 using 0.1 M Tris buffer.

[0036] 3. Immerse the base plate of the TORP implant in the prepared solution and place it in a constant temperature incubator at 37°C for 48 hours. After the reaction is complete, rinse with purified water.

[0037] 4. Prepare 0.1 M MES buffer solution with purified water, add 0.15 M EDC and 0.1 M NHS, stir well, adjust the pH to between 5 and 6, heat to 60℃, add 1% gelatin and dissolve completely.

[0038] 5. Immerse the chassis of the TORP in the above solution for 12 hours.

[0039] 6. Rinse the TORP prosthesis after reaction with purified water, place it in a -50℃ environment for vacuum freeze drying for 12 hours, keep it at 20℃ for 2 hours, and then sterilize it with EO.

[0040] Example 2 1. Soak the TORP prosthesis in isopropanol, ethanol, and purified water, and sonicate for 30 minutes each.

[0041] 2. Prepare a 1 mg / ml dopamine hydrochloride solution with pH 8.5 using 0.1 M Tris buffer.

[0042] 3. Immerse the base plate of the TORP implant in the prepared solution and place it in a constant temperature incubator at 37°C for 48 hours. After the reaction is complete, rinse with purified water.

[0043] 4. Prepare 0.1 M MES buffer with purified water, add 0.15 M EDC and 0.1 M NHS, stir well, adjust the pH to between 5 and 6, add 1% hyaluronic acid at room temperature and dissolve completely.

[0044] 5. Immerse the chassis of the TORP in the above solution for 12 hours.

[0045] 6. Rinse the TORP prosthesis after reaction with purified water, place it in a -50℃ environment for vacuum freeze drying for 12 hours, keep it at 20℃ for 2 hours, and then sterilize it with EO.

[0046] Example 3 1. Soak the PORP implant in isopropanol, ethanol, and purified water, and sonicate for 30 minutes each.

[0047] 2. Prepare a 1 mg / ml dopamine hydrochloride solution with pH 8.5 using 0.1 M Tris buffer.

[0048] 3. Immerse the PORP prosthesis base plate in the prepared solution and place it in a constant temperature incubator at 37°C for 48 hours. After the reaction is complete, rinse with purified water.

[0049] 4. Prepare 0.1 M MES buffer with purified water, add 0.15 M EDC and 0.1 M NHS, stir well, adjust the pH to between 5 and 6, add 1% hyaluronic acid at room temperature and dissolve completely.

[0050] 5. Immerse the chassis of the PORP in the above solution and react for 12 hours.

[0051] 6. Rinse the PORP prosthesis after reaction with purified water, place it in a -50℃ environment for vacuum freeze drying for 12 hours, keep it at 20℃ for 2 hours, and then sterilize it with EO.

[0052] Comparative Example 1 1. Soak the TORP prosthesis in isopropanol, ethanol, and purified water, and sonicate for 30 minutes each. Then dry at 50°C for 1 hour.

[0053] 2. EO sterilization.

[0054] Comparative Example 2 1. Soak the PORP prosthesis in isopropanol, ethanol, and purified water, and sonicate for 30 minutes each. Then dry at 50°C for 1 hour.

[0055] 2. EO sterilization.

[0056] Comparative Example 3 The TORP prosthesis was immersed in isopropanol, ethanol, and purified water, and sonicated for 30 minutes each, and then dried at 50°C for 1 hour.

[0057] 2. Prepare a 1 mg / ml dopamine hydrochloride solution with pH 8.5 using 0.1 M Tris buffer.

[0058] 3. Immerse the base plate of the TORP prosthesis in the prepared solution and place it in a constant temperature oven at 37°C for 48 hours. After the reaction is complete, rinse with purified water and dry.

[0059] 4. EO sterilization.

[0060] The fixation stability of the prostheses prepared in Examples 1-3 and Comparative Examples 1-3 after rehydration was tested. The schematic diagram of the fixation stability test is shown below. Figure 3 As shown, the prosthesis base contacts the tympanic membrane simulator 41, and the other end of the head contacts the stapes footplate simulator 42. After loading, a weight 3 is applied to the middle of the prosthesis rod for evaluation. The test results are shown in Table 1. The prosthesis should be stabilized and then subjected to a fixation stability test.

[0061] Test results: After the TORP prosthesis was installed into the fixation stability testing fixture, the fixation force of the TORP prosthesis was tested using weight 3. The results are shown in the table below.

[0062]

[0063] As shown in the table, the rehydration time in this case fully meets clinical requirements. The clinical implantation process takes about 5 minutes, and the hydrogel is successfully activated after rehydration. In contrast, in Comparative Example 3, the PDA layer only increases adhesion. In clinical use, it cannot, like the hydrogel, allow the prosthesis base to fully conform to the tympanic membrane, thus providing a larger adhesive area for better prosthesis fixation.

[0064] This article uses specific examples to illustrate the principles and implementation methods of the present invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of the present invention, including the best mode, and also to enable any person skilled in the art to practice the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A method for enhancing the fixation stability of artificial ossicle prostheses, characterized in that, Includes the following steps: Surface cleaning of the artificial ossicle prosthesis; The surface of the artificial ossicle prosthesis that contacts the middle ear tissue is placed in an alkaline dopamine solution for surface modification to form a polydopamine layer on the surface. The surface on which the polydopamine layer is formed is then placed in a reaction solution containing a carbodiimide activation system and reactants to react, so that the reactants are attached to the surface of the polydopamine layer and form an adhesive functional layer. The artificial ossicle prosthesis with the adhesive functional layer formed thereon is cleaned and dried to obtain the processed artificial ossicle prosthesis; The adhesive functional layer can rehydrate and restore its adhesive state after contact with human blood or tissue fluid, thereby improving the fixation stability of the artificial ossicle prosthesis in the early stage of implantation.

2. The processing method according to claim 1, characterized in that, The artificial ossicle prosthesis is one of a fully implanted ossicle prosthesis, a partially implanted ossicle prosthesis, or a stapes prosthesis; Wherein, when the artificial ossicle prosthesis is a fully implanted ossicle prosthesis or a partially implanted ossicle prosthesis, the surface in contact with the middle ear tissue is the base surface in contact with the tympanic membrane; when the artificial ossicle prosthesis is a stapes prosthesis, the surface in contact with the middle ear tissue is the hook surface in contact with the middle ear tissue.

3. The processing method according to claim 1, characterized in that, The alkaline dopamine solution is a dopamine hydrochloride solution prepared with a buffer solution with a pH of 8 to 9, wherein the buffer solution is one or more of phosphate buffer, Tris buffer or bicarbonate buffer, and the concentration of the dopamine hydrochloride solution is 1 to 3 mg / mL.

4. The processing method according to claim 1 or 3, characterized in that, The surface modification conditions include a reaction temperature of 37°C and a reaction time of 24 to 48 h.

5. The processing method according to claim 1, characterized in that, The carbodiimide activation system includes EDC and NHS, and the reaction solution also includes MES buffer. Preferably, the concentration of the MES buffer is 0.05 to 0.1 M, the concentration of the EDC is 0.1 to 0.4 M, the concentration of the NHS is 0.05 to 0.2 M, and the pH of the reaction solution is 5 to 6.

6. The processing method according to claim 1 or 5, characterized in that, The reactants are one or more of gelatin, hyaluronic acid, or cellulose sulfate, and the mass concentration of the reactants in the reaction solution is 1% to 5%, with a reaction time of 12 to 24 hours.

7. The processing method according to claim 1, characterized in that, The drying process is freeze-drying, which includes: placing the cleaned artificial ossicle prosthesis under vacuum freeze-drying at -50℃ for 12 hours, and then keeping it at 20℃ for 2 hours. Preferably, the process further includes packaging and sterilization steps after drying, wherein the packaging is blister packaging and the sterilization is gamma irradiation sterilization or ethylene oxide sterilization.

8. The processing method according to claim 1, characterized in that, The surface cleaning includes ultrasonic cleaning of the artificial ossicle prosthesis in sequence with isopropanol, ethanol and purified water.

9. An artificial ossicle prosthesis, characterized in that, It includes a metal prosthesis body and an adhesive functional layer disposed on the contact surface between the metal prosthesis body and the middle ear tissue. The adhesive functional layer includes a polydopamine layer located on the surface of the metal prosthesis body and a functional polymer layer attached to the surface of the polydopamine layer. The functional polymer layer has a sponge-like structure in the dry state. After contact with human blood or tissue fluid, it can rehydrate and restore its adhesive state, thereby improving the fixation stability of the artificial ossicle prosthesis in the early stage of implantation. The metal prosthesis body is made of pure titanium, nickel-titanium, or titanium alloy. The functional polymer in the functional polymer layer is one or more of gelatin, hyaluronic acid, or cellulose sulfate. The artificial ossicle prosthesis is a fully implanted ossicle prosthesis, a partially implanted ossicle prosthesis, or a stapes prosthesis. The adhesive functional layer is disposed on the base surface of the fully implanted ossicle prosthesis or the partially implanted ossicle prosthesis, or on the hook surface of the stapes prosthesis.

10. The use of the artificial ossicle prosthesis of claim 9 in the preparation of an implantable device for ossicular chain reconstruction.

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