A multi-functional applicator for the auricle and external auditory canal

Abstract

A multifunctional administration device for auricle and external auditory canal, including inflatable expansion column, the expansion column tail end is provided with administration ball, the expansion column head end is provided with and the limiting plug of human auricle cooperation, the limiting plug is close to the administration pad of human auricle one side and is provided with the detachable fixing belt of limiting plug outside, and the side close to human auricle of fixing belt is provided with fixed part. The utility model discloses in view of the deficiency of prior art, effectively solved the short drug retention time of existing ear administration mode, difficult to stable fixation, drug release uneven, wearing comfort poor and the low problem such as patient compliance.

Description

Technical Field

[0001] This utility model belongs to the field of medical devices, specifically relating to a multifunctional drug delivery device for the auricle and external auditory canal. Background Technology

[0002] Currently, for the treatment of ear diseases, medications typically need to act directly on the auricle or external auditory canal to achieve a local therapeutic effect. However, existing methods of ear drug delivery have many limitations, making it difficult for drugs to effectively reach the affected area and maintain their effect for a sufficient duration.

[0003] Current methods of ear medication administration mainly include ear drops, ointments, or medication-soaked cotton balls. While ear drops are convenient to use, they tend to flow out due to gravity or the shape of the ear canal, resulting in short drug retention time and low absorption efficiency. Furthermore, patients need to maintain a specific head posture when using ear drops to prevent rapid drug loss, which can be difficult for the elderly or those with limited mobility. Ointments, while improving drug adhesion to some extent, are difficult to precisely control the dosage and may cause ear canal blockage due to over-application, affecting normal hearing and ventilation. Another common method is to insert medication-soaked cotton balls into the ear canal, but this method often fails to ensure the stability of the cotton balls within the ear canal, making them prone to falling out due to patient movement or gravity. Additionally, the limited absorption capacity of cotton balls leads to uneven drug release, hindering sustained therapeutic effects.

[0004] Furthermore, existing ear canal medication devices often lack a stable fixation structure, making them prone to displacement or detachment during use. This is especially problematic when prolonged use is required to maintain medication efficacy, as it restricts patient movement and disrupts daily life. Devices targeting the auricle are even rarer. Traditional patches or dressings often fail to adhere tightly to the curved surface of the auricle, affecting drug absorption. Additionally, because the auricle is exposed, it is susceptible to external environmental influences, leading to drug evaporation or contamination.

[0005] Therefore, existing ear-based drug delivery methods suffer from problems such as unstable drug delivery, short drug retention time, and poor patient compliance. There is an urgent need for a new device that can deliver drugs to both the auricle and the external auditory canal to improve drug absorption efficiency, prolong the duration of drug effect, and ensure wearing comfort and stability. Utility Model Content

[0006] This invention addresses the shortcomings of existing technologies by providing a multifunctional drug delivery device for the auricle and external auditory canal. It effectively solves the problems of short drug retention time, difficulty in stable fixation, uneven drug release, poor wearing comfort, and low patient compliance in existing ear drug delivery methods.

[0007] The technical solution adopted by this utility model to solve the above problems is as follows: A multifunctional drug delivery device for the auricle and external auditory canal includes an expandable expansion column, a drug delivery ball at the tail end of the expansion column, a limiting plug at the head end of the expansion column that fits with the human auricle, a drug delivery pad on the side of the limiting plug near the human auricle, a detachable fixing strap on the outside of the limiting plug, and a fixing part on the side of the fixing strap near the human auricle.

[0008] Preferably, the expansion column comprises: The matrix layer is made of silicone, medical polyurethane or thermoplastic elastomer and has a hollow columnar structure. An expansion layer, which covers the outside of the substrate layer, is made of shape memory alloy, elastic foam or thermoplastic polymer material; The support layer, located between the expansion layer and the substrate layer, is made of polytetrafluoroethylene, polyetheretherketone, or high-density silicone and has a spiral structure.

[0009] Preferably, the drug delivery ball comprises: The outer layer is made of cotton fiber, polyvinyl alcohol fiber or medical nonwoven fabric, and has a spherical wound or compression-formed structure; An adsorption layer, located inside the outer layer, is made of hydrophilic sponge, polyurethane foam or cross-linked polyvinyl alcohol, and has a porous structure. A support layer, located inside the adsorption layer, is made of polypropylene, polyethylene, or polyetheretherketone and has a honeycomb or mesh structure. The connecting part, located at one end of the drug delivery ball, is made of medical silicone, thermoplastic elastomer or polyetheretherketone and is fixedly connected to the expansion column.

[0010] Preferably, the limiting plug includes: The main body layer is made of medical-grade silicone, polyurethane, or thermoplastic elastomer; A buffer layer, located on the side of the main body layer near the auricle, is made of shape memory polymer, silicone sponge, or foam material; The connecting part, located in the central region of the main body layer, is made of medical silicone or thermoplastic elastomer and is fixedly connected to the expansion column.

[0011] Preferably, the drug delivery pad comprises: The adsorption layer is made of cotton fiber, polyvinyl alcohol fiber or medical nonwoven fabric and has a sheet-like porous structure. The support layer, located inside the adsorption layer, is made of polyurethane foam, polypropylene, or polytetrafluoroethylene and has a mesh or honeycomb structure. The fixing layer is located on the side of the adsorption layer near the limiting plug. It is made of medical silicone, thermoplastic elastomer or polymer adhesive material, and has a film or adhesive layer structure, and is attached to the limiting plug.

[0012] Preferably, the fixing strap includes: The strip layer is made of medical fabric, elastic nylon or polyester fiber material, and has a strip structure. One end of the strip layer is provided with a first connecting part, which is fixed to the corresponding part on the limiting plug by Velcro. The support layer, located inside the strip layer, is made of polytetrafluoroethylene, polyetheretherketone, or high-density polyethylene and has a strip or mesh structure. The fixing part is located at the end of the belt layer away from the first connecting part, and is made of medical silicone, acrylic pressure-sensitive adhesive or thermoplastic elastomer. It has a sheet-like structure and is attached to the outer surface of the human auricle.

[0013] This utility model has a novel structure, ingenious design, and is simple and convenient to operate. Compared with the prior art, it has the following advantages: 1. This device uses an expandable expansion column, which includes a base layer, an expansion layer, and a support layer. It expands after insertion into the ear canal, ensuring stable fixation and avoiding the slippage problems of traditional ear drops or cotton balls. The expansion layer is made of shape memory alloy, elastic foam, or thermoplastic polymer material, which can recover its shape after being subjected to force, thus adapting to different ear canal shapes, enhancing wearing comfort, and ensuring that the medication can effectively remain in the ear canal, extending the duration of its effect.

[0014] 2. The drug delivery ball of this device is covered with an outer layer made of cotton fiber, polyvinyl alcohol fiber, or medical non-woven fabric, and has an internal porous adsorption layer and support layer. It can hold the drug solution and maintain a sustained-release effect. Compared with the traditional method of soaking cotton balls in medication, it can improve the stability of the drug solution and ensure uniform release, effectively avoiding excessively rapid drug loss or excessively high local concentrations. The drug delivery ball is fixedly connected to the expansion column via a connector, ensuring its stable presence in the ear canal and preventing it from falling off due to patient movement.

[0015] 3. The combination of the positioning plug and the fixing strap in this device ensures stable fixation on the auricle. The positioning plug conforms to the shape of the auricle and includes a cushioning layer made of shape memory polymer, silicone sponge, or foam material, enhancing softness and comfort. The fixing strap is made of medical-grade fabric, elastic nylon, or polyester fiber and is secured to the positioning plug with Velcro. The fixing part at the end is made of medical-grade silicone, acrylic pressure-sensitive adhesive, or thermoplastic elastomer, ensuring a close fit to the outer surface of the auricle and preventing loosening during wear. Compared to traditional ear medicated patches, this device offers greater stability and adaptability. Attached Figure Description

[0016] Figure 1 This is a first axonometric view of a multifunctional drug delivery device for the auricle and external auditory canal according to the present invention.

[0017] Figure 2 This is a second axonometric view of a multifunctional drug delivery device for the auricle and external auditory canal according to the present invention.

[0018] Figure 3 This is a third axonometric view of a multifunctional drug delivery device for the auricle and external auditory canal according to the present invention.

[0019] In the attached diagram: 1-expansion column, 2-drug delivery ball, 3-limiting plug, 4-fixation band. Detailed Implementation

[0020] The following are specific embodiments of the present invention, and the technical solution of the present invention will be further described in conjunction with the accompanying drawings. However, the present invention is not limited to these embodiments.

[0021] like Figure 1-3 As shown, this utility model provides a multifunctional drug delivery device for the auricle and external auditory canal, including an expandable expansion column 1, a drug delivery ball 2 at the tail end of the expansion column 1, a limiting plug 3 that fits with the human auricle at the head end of the expansion column 1, a drug delivery pad on the side of the limiting plug 3 near the human auricle, a detachable fixing strap 4 on the outside of the limiting plug 3, and a fixing part on the side of the fixing strap 4 near the human auricle.

[0022] The expansion pillar 1 employs a multi-layered structure, including a base layer, an expansion layer, and a support layer. The base layer, made of silicone, medical-grade polyurethane, or thermoplastic elastomer (TPE), has a hollow columnar structure, possessing flexibility and elasticity to adapt to different ear canal shapes and provide basic support. The expansion layer, covering the outer side of the base layer, is made of shape memory alloy, elastic foam, or thermoplastic polymer material, and can return to its preset shape after insertion into the ear canal, ensuring a tight fit between the expansion pillar 1 and the inner wall of the ear canal. The support layer, located between the expansion layer and the base layer, is made of polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), or high-density silicone, and has a spiral structure to provide additional stability and prevent excessive expansion or deformation. This structure ensures the device is reliably fixed within the ear canal while reducing pressure and improving comfort during wear.

[0023] The drug delivery ball 2 is located at the tail end of the expansion column 1. Its outer layer is made of cotton fiber, polyvinyl alcohol fiber, or medical non-woven fabric, and has a spherical, wound, or compressed structure to ensure uniform absorption of the drug solution. Internally, it consists of an adsorption layer and a support layer. The adsorption layer is made of hydrophilic sponge, polyurethane foam, or cross-linked polyvinyl alcohol (PVA), and has a porous structure to retain a certain amount of drug solution and release it slowly. The support layer is made of polypropylene (PP), polyethylene (PE), or polyetheretherketone (PEEK), and has a honeycomb or mesh structure to enhance the morphological stability of the ball and prevent deformation from affecting drug release. The drug delivery ball 2 is fixedly connected to the expansion column 1 via a connector made of medical silicone, TPE, or PEEK to ensure that it will not fall out of the ear canal due to external force.

[0024] The limiting plug 3 is shaped to match the contour of the auricle and includes a main body layer, a buffer layer, and a connecting part. The main body layer is made of medical-grade silicone, polyurethane, or TPE, providing basic support. The buffer layer, located on the side of the main body layer closest to the auricle, is made of shape memory polymer, silicone sponge, or foam material, which enhances fit and makes the device more stable. The connecting part, located in the center of the main body layer, is made of medical-grade silicone or TPE and is fixedly connected to the expansion pillar 1, ensuring that the entire device is stable between the ear canal and the auricle. A drug delivery pad is also provided on the side of the limiting plug 3 closest to the auricle. This pad includes an absorbent layer, a support layer, and a fixing layer. The absorbent layer is made of cotton fiber, polyvinyl alcohol fiber, or medical nonwoven fabric; the support layer is made of polyurethane foam, polypropylene, or PTFE; and the fixing layer is made of medical-grade silicone, TPE, or a polymer adhesive material, and is fitted and connected to the limiting plug 3 to ensure that the drug can be stably adhered to the surface of the auricle.

[0025] The fixing strap 4 enhances the wearing stability of the device and consists of a strap body layer, a support layer, and a fixing part. The strap body layer is made of medical fabric, elastic nylon, or polyester fiber, and has a strip-like structure. It is soft and has a certain degree of elasticity, allowing it to adapt to different ear shapes. One end of the strap body layer has a first connecting part, which uses Velcro (hook-loop fabric) to attach and fix it to the corresponding part of the limiting plug 3, ensuring that the device can be firmly attached to the surface of the auricle. The support layer is located inside the strap body layer and is made of PTFE, PEEK, or HDPE. It has a strip-like or mesh structure to enhance the tensile strength of the fixing strap and prevent it from falling off due to pulling. The end of the fixing strap 4 has a fixing part, which is made of medical silicone, acrylic pressure-sensitive adhesive, or TPE. It has a sheet-like structure and is attached to the outer surface of the auricle, further improving the wearing stability of the device.

[0026] This device, through the structural design of the expansion column 1, can be stably fixed in the ear canal. The combination of the limiting plug 3 and the fixing band 4 ensures that the entire device is stably attached to the auricle, preventing displacement or detachment. Simultaneously, the rational design of the drug delivery ball 2 and the drug delivery pad ensures stable drug release, meeting the treatment needs of various ear diseases.

[0027] The expansion column 1 adopts a multi-layer structure design, including a base layer, an expansion layer and a support layer. The layers are closely fitted together, so that it can provide support in the ear canal and adapt to different ear canal shapes, ensuring the stability and comfort of the device.

[0028] The matrix layer, located at the innermost part of the expansion column 1, is made of silicone, medical-grade polyurethane, or thermoplastic elastomer (TPE) and has a hollow columnar structure, providing a certain degree of flexibility and elasticity. The inner cavity of the matrix layer can be designed as a through-hole or closed structure according to specific needs to adapt to different processing techniques and usage requirements. The main function of this layer is to provide basic support for the entire expansion column while ensuring the basic shape of the device within the ear canal.

[0029] An expansion layer, made of shape memory alloy, elastic foam, or thermoplastic polymer, covers the outer side of the base layer. The material properties of this layer allow it to recover its preset shape after being compressed by external force, thus adapting to different ear canal sizes and achieving a stable fit. The shape memory alloy remains flexible at room temperature and recovers its shape under body temperature after insertion into the ear canal, enhancing wearing stability; the elastic foam expands within the ear canal, allowing the expansion column 1 to adhere tightly to the ear canal wall, thereby improving the device's fixation.

[0030] The support layer, located between the expansion layer and the substrate layer, is made of polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), or high-density silicone and features a spiral structure. This structure enhances the overall stability of the expansion column, preventing the device from losing its support due to deformation of the expansion layer. The spiral structure also provides a degree of elasticity, allowing the expansion column to cushion external forces, thereby improving wearing comfort. The choice of material for the support layer ensures the long-term performance of the device and can withstand a certain amount of mechanical stress, preventing the expansion column from deforming or breaking during use.

[0031] The expansion column 1, through a reasonable layered design, can be stably fixed within the ear canal while ensuring wearing comfort and adapting to different ear canal structures, thus improving its versatility. The device has a simple overall structure, uses appropriate materials, employs a mature manufacturing process, is easy to mass-produce, and is suitable for large-scale clinical applications.

[0032] The drug delivery ball 2 adopts a multi-layer composite structure design, including an outer layer, an adsorption layer, a support layer, and a connecting part. The layers are tightly bonded to ensure that it can stably store the drug solution and release it slowly during use, while having good structural strength to adapt to different ear canal shapes and remain fixed.

[0033] The outer layer, located on the outermost side of the drug delivery ball 2, is made of cotton fiber, polyvinyl alcohol fiber, or medical non-woven fabric, and has a spherical, wound, or compressed structure. This layer has good skin-friendliness, can adapt to the shape of the ear canal wall, and reduce irritation to the ear canal. In addition, the outer layer material has a certain degree of breathability, which can ensure uniform diffusion of the drug solution, while providing appropriate mechanical support to prevent the ball from collapsing or deforming in the ear canal.

[0034] The adsorption layer, located inside the outer layer, is made of hydrophilic sponge, polyurethane foam, or cross-linked polyvinyl alcohol (PVA) and has a porous structure. Its main function is to store the drug solution. This layer material has good water absorption and sustained-release properties, maintaining sufficient wettability after the drug solution is immersed and slowly releasing the drug solution through its microporous structure. The thickness and pore size of the adsorption layer can be adjusted according to the viscosity and release requirements of different drugs to ensure uniform release of the drug solution while preventing excessively rapid loss of the drug solution.

[0035] The support layer, located inside the adsorption layer, is made of polypropylene (PP), polyethylene (PE), or polyetheretherketone (PEEK) and has a honeycomb or mesh structure. This layer provides structural support, preventing the drug delivery ball 2 from collapsing or deforming under pressure or during use, thus ensuring the stability of the adsorption layer. Simultaneously, the honeycomb or mesh structure ensures permeability within the ball, allowing for uniform distribution of the drug solution and improving drug release.

[0036] A connecting part is located at one end of the drug delivery bulb 2, and is made of medical-grade silicone, thermoplastic elastomer (TPE), or polyetheretherketone (PEEK), and is fixedly connected to the expansion column 1. The connecting part can be fixed to the expansion column 1 by adhesive bonding or hot-melt welding to ensure the stability of the drug delivery bulb 2 in the ear canal and prevent it from falling off due to patient movement or external force. The material of the connecting part has good flexibility, allowing it to adapt to different ear canal shapes, while ensuring a certain mechanical strength to meet the needs of long-term use.

[0037] The limiting plug 3 adopts a layered structure design, including a main body layer, a buffer layer and a connecting part. The layers are tightly combined, which enables the device to stably fit the auricle, improve wearing comfort, and ensure the fixation effect of the expansion column 1 in the ear canal.

[0038] The main body layer is the primary support structure of the retainer 3, made of medical-grade silicone, polyurethane, or thermoplastic elastomer (TPE), possessing good flexibility and a certain degree of mechanical strength. The shape of this layer is designed according to the physiological structure of the human ear, featuring an arc or irregular curved surface structure that naturally conforms to the ear's curvature, avoiding concentrated local pressure and reducing discomfort from prolonged wear. The thickness and hardness of the main body layer can be adjusted according to usage needs to adapt to the ear shape of different individuals.

[0039] The buffer layer, located on the side of the main body closest to the auricle, is made of shape memory polymer, silicone sponge, or foam. Its main function is to provide soft cushioning, allowing the retainer 3 to better adapt to the physiological shape of the auricle and enhance wearing stability. This layer material has good resilience, deforming under pressure from the auricle and returning to its original shape after the pressure is removed, ensuring the device fits snugly to the auricle without causing excessive pressure on ear tissues. The surface of the buffer layer can be designed as a smooth surface or a micro-textured structure to further improve wearing comfort and stability.

[0040] The connecting part is located in the central area of ​​the limiting plug 3, and is made of medical-grade silicone or thermoplastic elastomer (TPE), and is fixedly connected to the expansion column 1. The shape of the connecting part can be designed as an adhesive type to ensure a tight connection between the limiting plug 3 and the expansion column 1, preventing it from easily loosening. The material of this component has good elasticity and durability, and can withstand long-term wear and repeated use, while ensuring the stability and reliability of the overall structure.

[0041] The drug delivery pad adopts a multi-layer composite structure design, including an adsorption layer, a support layer, and a fixing layer. Each layer is tightly bonded to ensure stable storage and sustained release of the drug, while maintaining structural strength so that it can fit the auricle for a long time and improve wearing comfort.

[0042] The absorbent layer, located on the outermost side of the medication pad, is made of cotton fibers, polyvinyl alcohol fibers, or medical non-woven fabric, and has a sheet-like porous structure. This layer material has excellent absorbency, retaining an appropriate amount of medication and distributing it evenly across the entire pad surface to increase the contact area between the medication and the skin. The porous structure ensures slow release of the medication, preventing rapid loss due to gravity, while its soft material reduces irritation to the ear and enhances wearing comfort.

[0043] The support layer, located inside the absorbent layer, is made of polyurethane foam, polypropylene (PP), or polytetrafluoroethylene (PTFE) and has a mesh or honeycomb structure. Its main function is to enhance the overall support performance of the drug delivery pad, preventing deformation or collapse due to prolonged use or drug immersion. The mesh or honeycomb structure maintains good breathability while ensuring sufficient strength, allowing air and drug to circulate freely and preventing localized moisture or drug buildup that could affect the drug's effectiveness.

[0044] The fixing layer is located on the side of the adsorption layer near the limiting plug 3. It is made of medical-grade silicone, thermoplastic elastomer (TPE), or polymer adhesive material, and has a film-like or adhesive layer structure, which is bonded to the limiting plug 3. The material of the fixing layer ensures that the drug delivery pad can be firmly attached to the limiting plug 3 and is not easy to fall off. Different fixing methods can be selected according to actual needs. For example, a polymer adhesive material can be used to give it a certain degree of removability, making it easy to replace and adjust, or a permanent hot melt adhesive method can be used to improve the adhesion and ensure long-term stability.

[0045] The fixing strap 4 adopts a layered composite structure design, including a strap body layer, a support layer and a fixing part. The structure of each layer is reasonably matched so that the device can stably fit the auricle, improve the stability of wearing, prevent the device from shifting or falling off due to external force, and at the same time ensure the comfort and adaptability of wearing.

[0046] The strap layer is the basic structure of the fixing strap 4, made of medical fabric, elastic nylon, or polyester fiber, and is in the form of a strip. This layer material has good softness and a certain degree of elasticity, which can adapt to different ear shapes and provide a comfortable fit when worn. One end of the strap layer has a first connecting part, which is fixed by Velcro to the corresponding part of the limiting plug 3 to ensure that the device can be firmly attached to the surface of the ear, while allowing the user to easily adjust the tightness to adapt to the wearing needs of different people.

[0047] The support layer, located inside the main body layer, is made of polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), or high-density polyethylene (HDPE) and has a strip or mesh structure. Its main function is to provide additional mechanical support, allowing the fixing strap 4 to maintain its shape under stress and preventing deformation or damage from stretching or prolonged use. The mesh structure design reduces material weight, improves breathability, and enhances the overall tensile strength of the fixing strap 4, ensuring a stable connection even in complex wearing environments.

[0048] The fixing part is located at the end of the strap layer away from the first connecting part. It is made of medical-grade silicone, acrylic pressure-sensitive adhesive, or thermoplastic elastomer (TPE), and has a sheet-like structure that adheres to the outer surface of the auricle. The function of this layer is to enhance the stability of the fixing strap 4 during wear, ensuring a tight fit to the auricle surface and preventing the device from loosening or falling off due to external forces during use. The material selection for the fixing part can be adjusted according to specific needs. For example, acrylic pressure-sensitive adhesive provides strong adhesion and is suitable for single use, while medical-grade silicone or TPE provides a certain degree of elasticity, ensuring that skin breathability is not affected during prolonged wear and improving comfort.

[0049] When using this device, ① first prepare the required medication solution, and evenly immerse the medication ball 2 and medication pad in the solution, ensuring that the outer cotton fibers or non-woven fabric absorb the solution evenly, while simultaneously ensuring that the internal adsorption layer is fully saturated to guarantee a continuous and slow release of the medication solution. After removal, gently squeeze the surface to moisten it but without excess medication dripping, to prevent medication loss during use. Check the immersion status of the medication ball 2 and medication pad to ensure sufficient adsorption and no dry areas before proceeding to the next step.

[0050] ② Unfold the fixing strap 4 and check if its Velcro connection is intact. Also, confirm that the surfaces of the limiting plug 3 and the medication pad are clean and uncontaminated. If necessary, wipe the limiting plug 3, fixing strap 4, and other parts in contact with the skin with an alcohol swab to ensure hygienic and safe wearing. If the expansion column 1 has deformed due to storage, gently heat or knead the expansion layer to restore it to its original shape, ensuring smooth insertion and a close fit to the inner wall of the ear canal. Select an expansion column 1 of appropriate size according to the patient's ear canal size to ensure comfort and stability during wear.

[0051] ③ When wearing the device, the user can adopt a supine or side-lying position for easy operation. Gently pull the auricle to open the ear canal appropriately, and slowly insert the expansion column 1 with the drug delivery ball 2 attached into the ear canal, ensuring that the tail end of the expansion column 1 is fully inserted into the ear canal and that the drug delivery ball 2 is stably attached to the deep part of the ear canal. After insertion, wait a while for the expansion layer to return to its original size due to its shape memory properties, thereby filling the ear canal space and ensuring that the device is stably fixed in the ear canal, preventing the device from loosening or falling off due to head movement.

[0052] ④ After ensuring the expansion column 1 is stable, attach the limiting plug 3 to the outside of the auricle, matching its shape and ensuring the buffer layer fits tightly against the auricle to improve stability and comfort. Then, attach the medication-soaked pad to the side of the limiting plug 3 closest to the auricle, ensuring its absorbent layer adheres closely to the auricle surface, guaranteeing continuous release and full coverage of the affected area. Gently press the medication pad to ensure its fixing layer fits tightly against the limiting plug 3, preventing displacement during wear.

[0053] ⑤ After fixing the limiting plug 3, adjust the fixing strap 4 so that the strap layer naturally conforms to the auricle, and use Velcro to attach and fix the first connecting part of the fixing strap 4 to the corresponding part on the limiting plug 3. At this time, you can gently pull the fixing strap 4 to ensure that the connection is firm and will not loosen due to slight external force. Then, attach the fixing part of the other end of the fixing strap 4 to the outer surface of the auricle, and gently press the fixing part to make it in close contact with the skin, which enhances the stability of the device and prevents the fixing strap from loosening due to head movement or external friction.

[0054] ⑥ After wearing the device, the user can gently shake their head or perform appropriate chewing movements to observe whether the device becomes loose or slips off. If it becomes loose, the adhesion of the fixing strap 4 can be readjusted, or the insertion depth of the expansion column 1 can be adjusted appropriately to ensure that the device is in the best fixed state. If it needs to be worn for a long time, the adhesion of the fixing strap 4 and the limiting plug 3 can be checked periodically during the wearing process to avoid the adhesion of the fixing part being affected by sweat or sebum. At the same time, check whether the medication pad is still moist. If it is found to be dry, the medication can be added appropriately or a new medication pad can be replaced.

[0055] ⑦ When removing the device, first loosen the Velcro connection of the fixing strap 4 and gently peel it off to completely detach the fixing strap 4. Then, hold the limiting plug 3 with your hand and gently rotate it along the ear canal axis to loosen the adhesion of the expansion column 1, avoiding ear canal discomfort caused by pulling it out directly. After the expansion column 1 is loosened, slowly remove the entire device and check the medication residue on the medication bulb 2 and medication pad. If a large amount of medication is still found in the absorbent layer, the wearing time can be appropriately extended according to treatment needs. After removal, clean the surface of the device with a cleaning solution or disinfectant, and disinfect or replace it appropriately according to material requirements to ensure safety for the next use.

[0056] The specific embodiments described herein are merely illustrative examples illustrating the spirit of this utility model. Those skilled in the art to which this utility model pertains may make various modifications or additions to the described specific embodiments or use similar methods to replace them, without departing from the spirit of this utility model or exceeding the scope defined by the appended claims.

Claims

1. A multifunctional drug delivery device for the auricle and external auditory canal, characterized in that, It includes an expandable expansion column (1), with a drug delivery ball (2) at the tail end of the expansion column (1), a limiting plug (3) that fits with the human auricle at the head end of the expansion column (1), a drug delivery pad on the side of the limiting plug (3) near the human auricle, a detachable fixing band (4) on the outside of the limiting plug (3), and a fixing part on the side of the fixing band (4) near the human auricle.

2. The multifunctional drug delivery device for the auricle and external auditory canal as described in claim 1, characterized in that, The expansion column (1) includes: The matrix layer is made of silicone, medical polyurethane or thermoplastic elastomer and has a hollow columnar structure. An expansion layer, which covers the outside of the substrate layer, is made of shape memory alloy, elastic foam or thermoplastic polymer material; The support layer, located between the expansion layer and the substrate layer, is made of polytetrafluoroethylene, polyetheretherketone, or high-density silicone and has a spiral structure.

3. A multifunctional drug delivery device for the auricle and external auditory canal as described in claim 1, characterized in that, The drug delivery ball (2) comprises: The outer layer is made of cotton fiber, polyvinyl alcohol fiber or medical nonwoven fabric, and has a spherical wound or compression-formed structure; An adsorption layer, located inside the outer layer, is made of hydrophilic sponge, polyurethane foam or cross-linked polyvinyl alcohol, and has a porous structure. A support layer, located inside the adsorption layer, is made of polypropylene, polyethylene, or polyetheretherketone and has a honeycomb or mesh structure. The connecting part, located at one end of the drug delivery ball (2), is made of medical silicone, thermoplastic elastomer or polyether ether ketone and is fixedly connected to the expansion column (1).

4. A multifunctional drug delivery device for the auricle and external auditory canal as described in claim 1, characterized in that, The limiting plug (3) includes: The main body layer is made of medical-grade silicone, polyurethane, or thermoplastic elastomer; A buffer layer, located on the side of the main body layer near the auricle, is made of shape memory polymer, silicone sponge, or foam material; The connecting part, located in the central region of the main body layer, is made of medical silicone or thermoplastic elastomer and is fixedly connected to the expansion column (1).

5. A multifunctional drug delivery device for the auricle and external auditory canal as described in claim 1, characterized in that, The drug delivery pad includes: The adsorption layer is made of cotton fiber, polyvinyl alcohol fiber or medical nonwoven fabric and has a sheet-like porous structure. The support layer, located inside the adsorption layer, is made of polyurethane foam, polypropylene, or polytetrafluoroethylene and has a mesh or honeycomb structure. The fixing layer is located on the side of the adsorption layer near the limiting plug (3), and is made of medical silicone, thermoplastic elastomer or polymer adhesive material. It has a film or adhesive layer structure and is attached to the limiting plug (3).

6. A multifunctional drug delivery device for the auricle and external auditory canal as described in claim 1, characterized in that, The fixing strap (4) includes: The strip layer is made of medical fabric, elastic nylon or polyester fiber material, and has a strip structure. One end of the strip layer is provided with a first connecting part, which is fixed to the corresponding part on the limiting plug (3) by Velcro. The support layer, located inside the strip layer, is made of polytetrafluoroethylene, polyetheretherketone, or high-density polyethylene and has a strip or mesh structure. The fixing part is located at the end of the belt layer away from the first connecting part, and is made of medical silicone, acrylic pressure-sensitive adhesive or thermoplastic elastomer. It has a sheet-like structure and is attached to the outer surface of the human auricle.

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