Ear protector

Abstract

The invention provides an ear protector, which relates to the technical field of medical stents and comprises a protective cover, an arc-shaped protective stent, a helix positioning stent and a cranium-ear angle stent, the protective cover is detachably connected with the arc-shaped protective bracket in a clamping manner; the helix positioning support is detachably arranged on the arc-shaped protection support, and the helix positioning support is clamped on the inner side of a helix of a patient to position and shape the helix; the cranioear angle support is arranged between the ear back and the skull of a patient to support the ear and prevent the post-operation ear from collapsing and deforming. The standardized ear protector is adopted to ensure that the ears are prevented from being affected by various adverse factors in the rehabilitation process, the helix positioning support is clamped on the inner side of the helix of a patient to position and shape the helix, the cranioear angle support is arranged between the ear back and the skull of the patient to support the ears so as to prevent the ears from collapsing and deforming after the operation, and the rehabilitation effect of the ears is improved. And the ears are covered in the ear protector through the protective cover, so that potential risks are avoided.

Description

Technical Field

[0001] The invention relates to the technical field of medical brackets, and in particular to an ear protector. Background Art

[0002] Since Tanzer pioneered modern ear reconstruction technology in the 1950s, ear surgery reconstruction technology has continued to develop. Currently, the methods used in clinical practice are mainly divided into two categories: (1) skin expansion method and (2) non-skin expansion method.

[0003] As for the skin expansion method, it is divided into the following according to the different areas of ear skin expansion: ultra-thin skin flap expansion method, because the expanded skin can only cover the front part of the ear stent, the ear stent needs to be covered with skin grafting, so it is commonly known as "half-coverage"; skin fascia expansion method, because the area of ​​the expanded skin flap tissue can cover the entire ear stent, so it is commonly known as "full-coverage". Regardless of "half-coverage" or "full-coverage" reconstructed ears, after the placement of the ear stent, the three-dimensional morphological positions of the reconstructed ear can be formed, but in order to improve the morphological appearance of the reconstructed ear, it is still necessary to perform another surgical repair to remove excess residual ear tissue. Therefore, the skin expansion method requires three operations: the first stage: expander implantation, the second stage: ear reconstruction, and the third stage: reconstructed ear trimming.

[0004] However, no matter which ear reconstruction surgery treatment is used, special care of the ear is required throughout the treatment cycle. In the past, doctors performed individualized treatment based on the individual conditions of the patients. There is still a lack of a standardized postoperative ear fixation and protection device to protect the ear from various adverse factors during the recovery process. For example: maintaining the shape of the reconstructed external ear, preventing displacement, avoiding potential risks such as external ear wound skin and cartilage infection, hematoma formation, and local tissue necrosis.

[0005] Currently, surgical tape or bandages are commonly used for postoperative fixation of the ear. Due to their own characteristics, these materials can only play a role of sticking and wrapping, but not supporting and fixing. They also have poor air permeability and are easily adhered to wound exudate, breeding bacteria and causing wound infection. Earmuffs can also be used for postoperative fixation of the ear. These materials have a single function, just covering the postoperative ear, and do not have the function of fixing the ear. They are not enough to support the special care needs after some complex ear surgeries. Summary of the invention

[0006] The technical problem to be solved by the present invention is to provide an ear protector to solve the problem that the existing ear postoperative fixation materials do not have a supporting and fixing function, have poor air permeability, are easily adhered to wound exudate, breed bacteria and thus cause wound infection.

[0007] In order to solve the above technical problems, the present invention provides the following technical solutions:

[0008] An ear protector comprises: a protective cover, an arc-shaped protective bracket, an ear helix positioning bracket and a skull ear angle bracket;

[0009] The protective cover is detachably engaged with the arc-shaped protective bracket;

[0010] The helix positioning bracket is detachably arranged on the arc-shaped protection bracket, and the helix positioning bracket is clamped on the inner side of the patient's helix to position and shape the helix;

[0011] The skull-ear angle bracket is arranged between the back of the ear and the skull of the patient to support the ear and prevent the ear from collapsing and deforming after surgery.

[0012] Compared with the prior art, the present invention has at least the following beneficial effects:

[0013] (1) In the present invention, a standardized ear protector is used to protect the ear from being affected by various adverse factors during the rehabilitation process. The helix positioning bracket is placed on the inner side of the patient's helix to position and shape the helix, so as to maintain the reconstructed external ear shape and prevent displacement. The skull ear angle bracket is set between the patient's back of the ear and the skull to support the ear to prevent postoperative ear collapse and deformation. The ear is covered inside the ear protector by a protective cover to avoid potential risks such as external ear wound skin and cartilage infection, hematoma formation, local tissue necrosis, etc.

[0014] (2) In the present invention, the protective cover, arc-shaped protective bracket, helix positioning bracket and skull ear angle bracket in the ear protector can be separated separately or used in combination according to the actual needs of the patient. For example, only the skull ear angle bracket can be set between the back of the ear and the skull of the patient to support the ear and prevent the ear from collapsing and deforming. The helix positioning bracket and the skull ear angle bracket can also be used in combination to achieve differentiated treatment purposes that vary from person to person.

[0015] (3) In the present invention, the ear protector can be used for both left and right ears. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The accompanying drawings, which are incorporated herein and constitute a part of the specification, illustrate embodiments of the invention and, together with the description, further serve to explain the principles of the invention and to enable those skilled in the relevant art to make and use the invention.

[0017] Figure 1 A schematic diagram of the structure of an ear protector provided by the present invention;

[0018] Figure 2 A schematic diagram of the structure of a protective cover provided by the present invention;

[0019] Figure 3 A schematic diagram of the structure of another protective cover provided by the present invention;

[0020] Figure 4 A schematic diagram of the structure of an arc-shaped protective bracket provided by the present invention;

[0021] Figure 5 A schematic structural diagram of an auricle positioning bracket provided by the present invention;

[0022] Figure 6 A schematic structural diagram of another helix positioning bracket provided by the present invention;

[0023] Figure 7 A schematic structural diagram of a skull-ear angle bracket provided by the present invention.

[0024] [Reference Signs]

[0025] 1. Protective cover; 11. First protruding structure; 12. Air vent; 13. Reinforcing ribs; 2. Arc-shaped protective bracket; 21. First groove structure; 22. Second groove structure; 3. Helix positioning bracket; 31. Second protruding structure; 32. Helix positioning strip; 4. Skull ear angle bracket; 41. Main body; 42. Round hook; 5. Medical double-sided tape.

[0026] As shown in the figure, in order to clearly implement the structure of the embodiment of the present invention, specific structures and devices are marked in the figure, but this is only for illustrative purposes and is not intended to limit the present invention to the specific structure, device and environment. According to specific needs, ordinary technicians in this field can adjust or modify these devices and environments. DETAILED DESCRIPTION

[0027] The ear protector provided by the present invention is described in detail below in conjunction with the accompanying drawings and specific embodiments. At the same time, it is explained here that in order to make the embodiments more detailed, the following embodiments are the best and preferred embodiments, and those skilled in the art may also adopt other alternatives to implement some known technologies; and the accompanying drawings are only for more specific description of the embodiments, and are not intended to specifically limit the present invention.

[0028] It should be noted that the references to "one embodiment", "embodiment", "exemplary embodiments", "some embodiments" and the like in the specification indicate that the embodiments described may include specific features, structures or characteristics, but not every embodiment may include the specific features, structures or characteristics. In addition, when a specific feature, structure or characteristic is described in conjunction with an embodiment, it should be within the knowledge of a person skilled in the art to implement such feature, structure or characteristic in conjunction with other embodiments (whether or not explicitly described).

[0029] In general, a term can be understood, at least in part, from its use in context. For example, depending, at least in part, on the context, the term "one or more" as used herein can be used to describe any feature, structure, or characteristic in the singular sense, or can be used to describe a combination of features, structures, or characteristics in the plural sense. Additionally, the term "based on" can be understood as not necessarily intended to convey an exclusive set of factors, but can instead, depending, at least in part, on the context, allow for the presence of other factors that are not necessarily explicitly described.

[0030] It will be understood that the meanings of “on,” “over,” and “above” in the present invention should be interpreted in the broadest manner, so that “on” not only means “directly on” something, but also includes the meaning of being “on” something with intervening features or layers therebetween, and “on” or “over” not only means “on” or “above” something, but also includes the meaning of being “on” or “above” something with no intervening features or layers therebetween.

[0031] Additionally, spatially relative terms such as "under," "beneath," "lower," "above," "upper," and the like may be used herein for descriptive convenience to describe the relationship of one element or feature to another element or features, as shown in the accompanying drawings. Spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the accompanying drawings. The device may be oriented in other ways, and the spatially relative descriptors used herein may be similarly interpreted accordingly.

[0032] like Figures 1 to 7 As shown, an embodiment of the present invention provides an ear protector, comprising: a protective cover 1, an arc-shaped protective bracket 2, an auricle positioning bracket 3 and a skull ear angle bracket 4.

[0033] The protective cover 1 is detachably connected to the arc-shaped protective bracket 2 by snapping.

[0034] The helix positioning bracket 3 is detachably arranged on the arc-shaped protection bracket 2, and the helix positioning bracket 3 is clamped on the inner side of the patient's helix to position and shape the helix.

[0035] The skull-ear angle support 4 is arranged between the back of the ear and the skull of the patient to support the ear and prevent the ear from collapsing and deforming after surgery.

[0036] It should be noted that the protective cover 1, arc-shaped protective bracket 2, helix positioning bracket 3 and skull ear corner bracket 4 in the ear protector can be separated separately or used in combination according to the actual needs of the patient. For example, only the skull ear corner bracket 4 can be used between the back of the patient's ear and the skull to support the ear and prevent the ear from collapsing and deforming. The helix positioning bracket 3 and the skull ear corner bracket 4 can also be used in combination to achieve differentiated treatment purposes that vary from person to person.

[0037] Furthermore, the ear protector can be used for both left and right ears.

[0038] Compared with the prior art, the present invention has at least the following beneficial effects:

[0039] In the present invention, a standardized ear protector is used to protect the ear from being affected by various adverse factors during the rehabilitation process. The helix positioning bracket is placed on the inner side of the patient's helix to position and shape the helix to maintain the reconstructed external ear shape and prevent displacement. The skull ear angle bracket is set between the patient's back of the ear and the skull to support the ear to prevent postoperative ear collapse and deformation. The ear is covered inside the ear protector by a protective cover to avoid potential risks such as external ear wound skin and cartilage infection, hematoma formation, local tissue necrosis, etc.

[0040] In a possible implementation, the protective cover 1 is provided with two or more first protrusion structures 11, and the arc-shaped protective bracket 2 is provided with two or more first groove structures 21. The protective cover 1 and the arc-shaped protective bracket 2 are detachably engaged and connected through the cooperation of the first protrusion structure 11 and the first groove structure 21.

[0041] In the present invention, a detachable snap-fit ​​connection is achieved through the cooperation between the first protrusion structure 11 and the first groove structure 21, thereby improving the stability of the connection and ensuring that the protective cover 1 is not easily loosened during use, while maintaining the convenience of disassembly and assembly, facilitating cleaning, replacement or adjusting the structure as needed, thereby enhancing the practicality and flexibility of the product.

[0042] In a possible implementation, the helix positioning bracket 3 is provided with a second protrusion structure 31, and the arc-shaped protection bracket 2 is provided with a second groove structure 22. The helix positioning bracket 3 is detachably arranged on the arc-shaped protection bracket 2 through the cooperation of the second protrusion structure 31 and the second groove structure 22.

[0043] In the present invention, the auricle positioning bracket 3 is detachably arranged on the arc-shaped protective bracket 2 through the cooperation of the second protrusion structure 31 and the second groove structure 22, which is convenient for adjusting or replacing the auricle positioning bracket according to the actual needs of the patient, ensuring that the positioning bracket can accurately adapt to the shape of the patient's ear, and is easy to clean and maintain, thereby improving the flexibility of the product and the accuracy of treatment.

[0044] In a possible implementation manner, the first groove structure 21 is disposed on the outer side of the arc-shaped protection bracket 2 , and the second groove structure 22 is disposed on the inner side of the arc-shaped protection bracket 2 .

[0045] In the present invention, the first groove structure 21 is arranged on the outer side of the arc-shaped protective bracket 2, and the second groove structure 22 is arranged on the inner side of the arc-shaped protective bracket 2. Such a distribution design can effectively distinguish the engagement positions of different components, avoid interference between components, improve the stability and convenience of installation, and optimize the overall structural layout, so that the protector is more ergonomic and meets usage requirements.

[0046] In a possible implementation manner, the protective cover 1 is provided with air holes 12 and reinforcing ribs 13 .

[0047] In the present invention, the ventilation holes 12 improve air circulation, reduce the stuffiness and discomfort caused by long-term wearing, and enhance the comfort of the user.

[0048] Furthermore, the reinforcing ribs 13 improve the structural strength of the protective cover and prevent deformation or damage, thereby ensuring that the protector is comfortable and stable during use and extending its service life.

[0049] In a possible implementation, a medical double-sided adhesive tape 5 is provided on the back of the arc-shaped protective bracket 2, and the medical double-sided adhesive tape 5 is used to adhere and fix the arc-shaped protective bracket 2 to a corresponding position of the patient's ear.

[0050] In the present invention, the design of setting the medical double-sided adhesive tape 5 on the back of the arc-shaped protective bracket 2 can ensure that the bracket can be firmly attached to the corresponding position of the patient's ear, effectively prevent displacement or falling off, and avoid the additional pressure or discomfort that may be caused by the traditional fixing method. The medical double-sided adhesive tape 5 is soft and safe, suitable for direct contact with the skin, which not only improves the wearing comfort, but also simplifies the fixing process, and improves the convenience and reliability of use.

[0051] In a possible implementation, the helix positioning bracket 3 is provided with a helix positioning strip 32, and the helix positioning strip 32 is clamped on the inner side of the patient's helix to maintain the curvature and angle of the patient's helix after surgery.

[0052] In the present invention, the helix positioning bracket 3 is provided with an helix positioning strip 32, and the helix positioning strip 32 is clamped on the inner side of the patient's helix, which can effectively fix and maintain the curvature and angle of the patient's helix after surgery, prevent shape deformation or displacement, and help stabilize the postoperative recovery effect. At the same time, this design is simple and easy to use, forms precise support for the patient's ear, avoids the discomfort or complicated operation problems that may be caused by traditional fixing methods, and improves the comfort of use and the treatment effect.

[0053] In a possible implementation, the helix positioning strip 32 is disposed on the helix positioning bracket 3. The helix positioning strip 32 is built with a deformable and adjustable alloy material. The helix positioning strip 32 can be adjusted according to the curvature and angle of the patient's helix after surgery.

[0054] In the present invention, the helix positioning strip 32 is designed with a deformable and adjustable alloy material, so that it can be flexibly adjusted according to the curvature and angle of the helix after surgery, providing personalized support and fixation. This design not only improves the adaptability to different patient ear shapes, but also better maintains the restored shape of the helix after surgery to avoid deformation or displacement. At the same time, the adjustment function also enhances the convenience and comfort of the product, which helps to improve the postoperative recovery effect and patient experience.

[0055] In a possible implementation, the skull-ear angle support 4 includes a main body 41 and a round hook 42. The main body 41 is arranged between the back of the ear and the skull of the patient to support the ear and prevent the ear from collapsing and deforming. The round hook 42 is hung on the patient's ear for auxiliary fixation and protection.

[0056] In the present invention, the main body 41 is placed between the back of the ear and the skull to provide stable support for the ear and prevent the ear from collapsing or deforming after surgery or during recovery. The round hook 42 is hung on the ear to further enhance the fixation effect and prevent the bracket from shifting or falling off. This design can not only ensure the stability of the ear shape, but also improve the safety and comfort of wearing, and is suitable for long-term use and complex postoperative recovery scenarios.

[0057] In a possible implementation, a deformable and adjustable flexible metal strip is provided in the skull-ear angle support 4, and the arc angle between the circular hook portion 42 and the main body portion 41 can be adjusted flexibly according to the skull-ear angle of the patient to provide personalized support.

[0058] In a possible implementation manner, the arc-shaped protective bracket 2 includes multiple models, and different models of arc-shaped protective brackets 2 have different degrees of encirclement. Different models of arc-shaped protective brackets 2 are equipped with corresponding models of protective covers 1.

[0059] In the present invention, the arc-shaped protective bracket 2 is designed in multiple models, and different degrees of envelopment are provided according to different models, and the corresponding models of protective covers 1 are matched at the same time. This design can meet the personalized requirements of different patients' ear morphology and postoperative needs. By providing a variety of options, it is ensured that the protector fits the shape of the patient's ear while supporting and protecting, improving the comfort and stability of wearing. In addition, the multi-model design enhances the adaptability and flexibility of the product, and is suitable for a wider range of user groups and clinical scenarios.

[0060] In a possible implementation manner, the helix positioning bracket 3 includes multiple models, and different models of the helix positioning bracket 3 have different lengths.

[0061] In the present invention, the helix positioning bracket 3 is designed in multiple models and has different lengths, which can be selected according to the patient's ear morphology and postoperative needs. The advantage of this design is that it can more accurately adapt to the helix size and curvature of different patients, provide personalized positioning and support effects, and ensure the stability of the helix after surgery. At the same time, the multi-model design increases the scope of application of the product, meets the needs of more patients, and enhances the flexibility and practicality of clinical use.

[0062] In a possible implementation manner, the skull-ear angle bracket 4 includes multiple models, and different models of skull-ear angle brackets 4 have different supporting angles.

[0063] In the present invention, the skull-ear angle bracket 4 is designed in a variety of models and provides different support angles, which can be personalized according to the patient's ear shape and postoperative needs. The advantage of this design is that it can more accurately adapt to the anatomical characteristics of the ears of different patients, provide the best support effect, and prevent the ears from collapsing or deforming. At the same time, the choice of multiple support angles enhances the applicability of the product, can meet diverse clinical needs, and improve postoperative recovery effects and patient comfort.

[0064] In order to achieve good support and wearing comfort of the ear protector, the present invention optimizes the structural parameters of the ear protector. The specific optimization scheme mainly includes the following steps:

[0065] Step 1: Collect a large amount of 3D scan data of patients' ears, mark and parameterize the key areas of the ears.

[0066] Among them, the key areas of the ear include the helix, back of the ear, skull contact point, etc.

[0067] It should be noted that by collecting 3D scanning data of the patient's ear and marking and parameterizing key areas (such as the helix, antihelix, back of ear, cranial ear angle, skull contact point, etc.), the geometric characteristics of different patients' ear morphologies can be obtained. This method provides a real and reliable data basis for the design of the protector, which helps to optimize the fit between the protector and the ear and improve wearing comfort and stability.

[0068] Step 2: Use principal component analysis or K-means clustering method to determine the representative model of ear morphology, so as to optimize the size design of the protector using the representative model.

[0069] Specifically, principal component analysis (PCA) is used to determine the representative model of ear morphology. First, a large amount of ear 3D scanning data is collected and standardized. Different ear morphologies are aligned through Procrustes analysis to remove the effects of rotation, scaling, and displacement. Then, the ear morphology matrix is ​​constructed, and the main eigenvectors (principal components) are extracted through PCA. The first few principal components with a cumulative variance contribution rate of 90%-95% are selected to describe the main change characteristics of the ear morphology. Finally, a representative ear model is generated based on the linear combination of the average ear shape and the principal components, thereby covering diverse ear morphologies while reducing complexity, providing a scientific basis for the size design of the ear protector. Principal component analysis (PCA) is already a very mature prior art and will not be repeated in the present invention.

[0070] Furthermore, K-means clustering is used to determine the representative model of ear morphology. First, the key features in the ear 3D scanning data (such as helix length, dorsal curvature of the ear, cranial ear angle, skull contact point position, etc.) are extracted, and a feature matrix is ​​constructed and standardized. Then, the ear morphology data is divided into multiple clusters by K-means clustering, and each cluster represents a class of ear models with similar morphological features. A representative ear model is generated by calculating the center point of each cluster (i.e., the center of mass of the cluster). These representative models can cover different categories of ear morphology, provide diversified references for the size optimization of ear protectors, and simplify the design complexity. The optimal number of clusters is usually determined by the elbow rule or the silhouette coefficient. K-means clustering is already a very mature prior art, and the present invention will not go into details.

[0071] It should be noted that the use of principal component analysis (PCA) or K-means clustering method to determine the representative model of ear morphology can transform the complex and diverse ear morphology data into a representative parametric model to reduce the design complexity. By generating representative models, the needs of different patients can be covered more efficiently while reducing development and production costs.

[0072] Step 3: Use COMSOL software to construct a representative geometric model of the ear morphology and a geometric model of the ear protector.

[0073] Step 4: Couple the representative geometric model of the ear morphology and the geometric model of the ear protector.

[0074] Specifically, in the coupling analysis, it is necessary to define the physical interaction between the ear protector and the ear geometry model. The contact mechanics model can be used to define the contact behavior between the ear protector and the ear surface. Set the ear protector material and the ear material. Set boundary conditions, such as the fixed position of the contact area between the protector and the ear, to simulate the stability of the protector. Then apply external force loads, such as the holding force of the helix positioning bracket on the helix and the supporting force of the skull ear angle bracket on the back of the ear. Mesh the ear morphology model and the protector model, and it is recommended to use tetrahedral meshes or hexahedral meshes. Then, static analysis and dynamic analysis can be performed to calculate the static force of the ear protector on the ear, including the holding force of the helix positioning bracket and the supporting force of the skull ear angle bracket, and the dynamic behavior during the wearing of the protector (such as force application and adjustment) can be simulated to analyze the deformation of the protector and the supporting effect on the ear.

[0075] It should be noted that the comfort level of patients wearing ear protectors is mainly related to the holding force of the helix positioning bracket on the helix, the supporting force of the skull ear angle bracket on the back of the ear and the breathability of the ear protector.

[0076] Step 5: Based on the holding force model of Hooke's law, determine the holding force of the helix positioning bracket on the helix:

[0077]

[0078] Among them, F L represents the holding force of the helix locating bracket on the helix, k represents the elastic coefficient of the helix locating bracket, which is related to the material selected for the helix locating bracket, and Δx represents the deformation of the helix locating bracket, which depends on the geometric changes in the initial design shape and the stretching after wearing.

[0079] Step 6: Based on the bending beam model, determine the support force of the cranial ear angle bracket for the back of the ear:

[0080]

[0081] Among them, F A It represents the supporting force of the cranial ear angle bracket for the back of the ear, E represents the elastic modulus of the cranial ear angle bracket, I represents the moment of inertia of the cross section of the cranial ear angle bracket, d represents the compression displacement of the cranial ear angle bracket, and L represents the supporting length of the cranial ear angle bracket.

[0082] Step 7: Determine the breathability of the ear protector based on the ratio of the vent area to the total area of ​​the cover:

[0083]

[0084] Among them, T represents air permeability, A t Indicates the vent area, A total Indicates the total area of ​​the protective cover.

[0085] Furthermore, on the basis of ensuring the comfort of patients wearing ear protectors, the structural strength of ear protectors should also be considered. And it is understandable that there is a conflict between structural strength and breathability. To obtain better breathability, larger air holes need to be opened, and larger air holes will reduce the structural strength of the entire auricle protector. Therefore, in the optimization process, it is necessary to set the structural strength not lower than the structural safety threshold. Structural strength can be evaluated by stress, deformation and safety factor.

[0086] Step 8: Based on the holding force of the helix positioning bracket on the helix, the supporting force of the cranial ear angle bracket on the back of the ear, and the breathability of the ear protector, fit the wearing comfort of the ear protector:

[0087]

[0088] Among them, S represents wearing comfort, F L Indicates the holding force of the helix positioning bracket on the helix, A L Indicates the contact area between the helix positioning bracket and the helix, F A Indicates the support force of the cranial ear angle bracket on the back of the ear, A A represents the contact area between the cranial ear angle bracket and the back of the ear, T represents air permeability, and λ 0 , 1 , …, λ 6 represents the fitting coefficient.

[0089] It should be noted that the nonlinear relationship between the helix positioning bracket holding force, the cranial ear angle bracket support force, and the air permeability and comfort is captured through polynomial fitting, which can reflect the impact of contact force (holding force and support force) on local pressure distribution and the contribution of air permeability to overall wearing comfort. The advantage of this modeling method is that it can comprehensively evaluate and optimize the design parameters of the ear protector, guide design improvements, and maximize the wearing comfort of the protector while meeting functional requirements.

[0090] Step 9: Set constraints for the ear protector optimization process.

[0091] Among them, the constraints include: structural strength constraints, functional constraints, manufacturing process constraints, biocompatibility constraints, etc.

[0092] Furthermore, the structural strength constraint may mean that the structural strength must not be lower than a structural safety threshold.

[0093] Furthermore, functional constraints may include: helix positioning constraints, cranial ear angle support constraints, and protective constraints. The helix positioning constraint may refer to that the holding force of the helix positioning bracket on the helix cannot be less than the holding force threshold. If the holding force of the helix positioning bracket on the helix is ​​less than the holding force threshold, the helix positioning bracket will not be able to play a role in positioning and shaping the helix. The cranial ear angle support constraint may refer to that the supporting force of the cranial ear angle bracket on the back of the ear cannot be less than the supporting force threshold. If the cranial ear angle support constraint may refer to that the supporting force of the cranial ear angle bracket on the back of the ear is less than the supporting force threshold, the cranial ear angle bracket will not be able to prevent the ear from collapsing and deforming. The protective constraint may refer to that the area of ​​the air vent cannot be higher than the area threshold. The ear protector needs to be able to prevent foreign matter (such as dust, particles, bacteria, etc.) from entering the ear, while ensuring that the air vent will not become a channel for foreign matter to enter. If the area of ​​the air vent is higher than the area threshold, it will be difficult to achieve the protective effect of the ear protector.

[0094] Furthermore, the manufacturing process constraint means that the geometric structure of the protector must comply with the processing technology limitations, such as the minimum wall thickness constraint of injection molding.

[0095] Furthermore, biocompatibility constraints mean that as a medical product that contacts the skin, ear protectors must meet biocompatibility requirements. For example, the materials used must pass ISO 10993 or other relevant biocompatibility tests to avoid skin allergies or irritation.

[0096] Step 10: With the goal of improving wearing comfort and reducing manufacturing costs, set the fitness function of the bat optimization algorithm:

[0097]

[0098] Where f represents the fitness function, X represents the structural parameters of the ear protector, B represents the manufacturing cost, η 1 Represents the weight coefficient of wearing comfort, η 2 Represents the weight coefficient of manufacturing cost.

[0099] Alternatively, the manufacturing cost can be simply estimated by the volume of the ear protector:

[0100]

[0101] Wherein, V represents the total volume of the ear protector, and b represents the manufacturing cost per unit volume of the ear protector.

[0102] Step 11: Determine the optimal structural parameters of the ear protector through the bat optimization algorithm.

[0103] Among them, the structural parameters of the ear protector mainly include the length, width, thickness, contact area with the helix, and material elastic modulus of the auricle positioning bracket, the length, width, thickness, and curvature of the arc-shaped protection bracket, the length, width, thickness, contact area with the auricle, bracket angle, and material elastic modulus of the skull ear angle bracket, the length, width, thickness, air vent diameter, air vent distribution density, and material strength of the protective cover, etc.

[0104] Among them, the Bat Algorithm (BA) is an intelligent optimization algorithm based on the behavior of bats in nature. The algorithm imitates the mechanism of bats using echolocation to search for prey, and performs global search and local search in the solution space to solve complex optimization problems.

[0105] Specifically, the bat individuals are initialized, each bat individual represents a feasible set of ear protector structure parameters, each bat individual is composed of multiple dimensional components, and each component represents a structural parameter.

[0106] In the global search phase, update the flight speed and position of individual bats:

[0107]

[0108] Among them, f i represents the pulse emission frequency of the i-th bat individual, f min Indicates the minimum pulse transmission frequency, f max Indicates the maximum value of pulse emission frequency, β t represents the nonlinear arccosine acceleration factor at t iterations, represents the speed of the i-th bat individual at the t+1th iteration, r 1 、r 2 Represents a random number between 0 and 1, ω t represents the inertia weight factor at t iterations, represents the speed of the i-th bat individual at the t-th iteration, represents the individual optimal solution, c i represents the learning factor, represents the global optimal solution, represents the position of the i-th bat individual at the t-th iteration, represents the position of the i-th bat individual at the t+1th iteration, and Levy represents the Levy flight step.

[0109] It should be noted that in the global search stage, by updating the flight speed and position of individual bats, using the pulse emission frequency to control the search range, and combining the nonlinear arccosine acceleration factor and inertia weight factor to balance the global exploration and local development capabilities, the algorithm can search the global solution space more extensively in the early stage, and gradually focus on the optimal solution area in the later stage. At the same time, the search direction is guided by using the individual optimal solution and the global optimal solution, and the randomness is enhanced by the Levy flight step length to effectively jump out of the local optimum. This method can improve the global optimization ability of the algorithm and ensure that the optimal solution to the optimization problem is found more efficiently and accurately.

[0110] Optionally, the inertia weight factor is specifically:

[0111]

[0112] Among them, ω t represents the inertia weight factor at the tth iteration, ω min represents the minimum inertia weight factor, ω max represents the maximum inertia weight factor, t represents the current number of iterations, and T represents the maximum number of iterations.

[0113] It should be noted that by adopting a linearly decreasing inertia weight factor, the algorithm gives individual bats a larger inertia weight in the early stages of iteration, thereby enhancing the global exploration capability and widely searching for possible solutions in the search space. In the later stages of iteration, the inertia weight gradually decreases, prompting the algorithm to focus more on local development and refined search to converge to the optimal solution more quickly. This dynamic adjustment method effectively balances the algorithm's global and local search capabilities, improves optimization efficiency, and reduces the risk of falling into local optimality.

[0114] Optionally, the nonlinear arccosine acceleration factor is specifically:

[0115]

[0116] Among them, arccos represents the arccosine function, t represents the current number of iterations, and T represents the maximum number of iterations.

[0117] It should be noted that by using the nonlinear arccosine acceleration factor, the search range in the bat algorithm can be dynamically adjusted. Its characteristic is that the acceleration factor changes relatively slowly in the early stage, allowing a wider global exploration. Then, as the number of iterations increases, the change gradually accelerates, prompting the search to focus on the local optimal area. This nonlinear adjustment method is more flexible than the linear method, and can provide the algorithm with adaptive search capabilities at different stages of iteration, thereby improving the algorithm's ability to jump out of the local optimal solution, while enhancing the convergence efficiency in the later stage, ensuring that the global optimal solution is found faster.

[0118] Optionally, the learning factor is specifically:

[0119]

[0120] Among them, c i represents the learning factor of the i-th bat individual, c max represents the maximum learning factor, c min Represents the minimum learning factor.

[0121] It should be noted that by dynamically adjusting the learning factor to gradually decrease with the change of the nonlinear arccosine acceleration factor, a larger learning factor is given to individual bats in the early stage of the algorithm, which enhances the individual's ability to learn the global optimal solution and its own historical optimal solution, thereby accelerating the global search. In the later stage of the iteration, the learning factor is gradually reduced to reduce excessive dependence on the optimal solution, improve the stability of the search, and prevent skipping of local fine search. This design can balance the effects of global exploration and local development, and improve the search efficiency and convergence accuracy of the algorithm.

[0122] Optionally, the Levy flight step length is specifically:

[0123]

[0124] Where Γ represents the standard Gamma function, λ represents the exponential parameter, and s represents the size parameter.

[0125] It should be noted that the Levy flight step introduces a random search strategy with long jump characteristics, which enables the algorithm to have a stronger ability to jump out of the local optimal solution during the global search process.

[0126] Randomly generate a random number r between 0 and 1 3 , determine the random number r 3 Is it greater than the pulse rate? If so, enter the local search phase. Otherwise, enter the update pulse rate and pulse average loudness.

[0127] In the local search phase, a solution is selected from the optimal solution set to generate a new local solution:

[0128]

[0129] in, represents the average loudness of the pulse emitted by the i-th bat individual at the tth iteration, ε represents a random number between 0 and 1, represents the average loudness of the pulse emitted by the i-th bat individual at the tth iteration, and α represents the pulse loudness attenuation coefficient.

[0130] It should be noted that in the local search stage, by selecting a solution from the current optimal solution set and generating a new local solution based on the average loudness of the pulse and the random factor, the solution can be fine-tuned and locally developed. This can not only ensure that the search space near the optimal solution is fully explored, but also enhance the convergence accuracy in the later stage, improve the local search efficiency, and avoid missing potential better solutions.

[0131] Calculate the fitness value of the new local solution and generate a random number r between 0 and 1 4 , determine whether and If yes, accept the new local solution. Otherwise, do not accept the new local solution.

[0132] Update the pulse rate and average loudness of the pulses:

[0133]

[0134] in, represents the pulse rate emitted by the i-th bat individual at the t+1th iteration, represents the initial pulse rate emitted by the i-th bat individual, e represents the natural constant, γ represents the pulse rate enhancement coefficient, represents the average loudness of the pulse emitted by the i-th bat individual at the tth iteration, and α represents the pulse loudness attenuation coefficient.

[0135] It should be noted that the pulse rate gradually increases with the number of iterations (controlled by the exponential growth formula), allowing the algorithm to explore new solutions more frequently in the later stages and enhance local search capabilities. The average loudness of the pulses gradually decays with iterations, allowing bats to focus on a smaller range of high-quality solutions in the later stages. This design achieves a dynamic balance between exploration and development during the optimization process, which helps the algorithm to conduct a global search in the early stages to avoid falling into a local optimal solution, and to refine the search in the later stages to ensure convergence to the global optimal solution.

[0136] Determine whether the current number of iterations has reached the maximum number of iterations; if so, output the ear protector structure parameter set representing the bat individual with the highest current fitness; otherwise, return to continue iteration.

[0137] In the present invention, the optimal structural parameters of the ear protector are determined by the bat optimization algorithm, which can efficiently balance key performance indicators such as breathability, structural strength and comfort in complex multi-objective optimization problems. The bat optimization algorithm combines global search and local development capabilities, and dynamically adjusts the speed, position, pulse rate and average loudness of individuals to achieve comprehensive exploration and local fine optimization of the solution space, avoiding falling into local optimality and accelerating the convergence speed. This method can find the optimal structural design while satisfying constraints (such as holding force, support force, protection, etc.), improve the functionality and wearing experience of the ear protector, and reduce the cost and complexity of manual design optimization.

[0138] The present invention covers any substitution, modification, equivalent method and scheme made on the essence and scope of the present invention. In order to make the public have a thorough understanding of the present invention, specific details are described in detail in the preferred embodiments of the present invention, but those skilled in the art can fully understand the present invention without the description of these details. In addition, in order to avoid unnecessary confusion about the essence of the present invention, well-known methods, processes, procedures, components and circuits are not described in detail.

[0139] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. An ear protector, characterized in that: include: A protective cover (1), an arc-shaped protective bracket (2), an ear helix positioning bracket (3) and a skull ear angle bracket (4); The protective cover (1) is detachably snap-connected to the arc-shaped protective bracket (2); The helix positioning bracket (3) is detachably arranged on the arc-shaped protection bracket (2), and the helix positioning bracket (3) is clamped on the inner side of the patient's helix to position and shape the helix; The skull-ear angle support (4) is arranged between the back of the ear and the skull of the patient to support the ear and prevent the ear from collapsing and deforming after surgery.

2. The ear protector according to claim 1, characterized in that The protective cover (1) is provided with two or more first protrusion structures (11), and the arc-shaped protective bracket (2) is provided with two or more first groove structures (21); the protective cover (1) and the arc-shaped protective bracket (2) are detachably engaged and connected through the cooperation of the first protrusion structures (11) and the first groove structures (21).

3. The ear protector according to claim 2, characterized in that The helix positioning bracket (3) is provided with a second protrusion structure (31), and the arc-shaped protection bracket (2) is provided with a second groove structure (22); the helix positioning bracket (3) is detachably arranged on the arc-shaped protection bracket (2) through the cooperation of the second protrusion structure (31) and the second groove structure (22).

4. The ear protector according to claim 3, characterized in that The first groove structure (21) is arranged on the outside of the arc-shaped protection bracket (2), and the second groove structure (22) is arranged on the inside of the arc-shaped protection bracket (2).

5. The ear protector according to claim 1, characterized in that The protective cover (1) is provided with air holes (12) and reinforcing ribs (13).

6. The ear protector according to claim 1, characterized in that A medical double-sided adhesive tape (5) is provided on the back of the arc-shaped protective bracket (2), and the medical double-sided adhesive tape (5) is used to adhere and fix the arc-shaped protective bracket (2) to a corresponding position of the patient's ear.

7. The ear protector according to claim 1, characterized in that The helix positioning bracket (3) is provided with a helix positioning strip (32), and the helix positioning strip (32) is clamped on the inner side of the patient's helix to maintain the curvature and angle of the patient's helix after surgery.

8. The ear protector according to claim 7, characterized in that The helix positioning strip (32) is arranged on the helix positioning bracket (3), and the helix positioning strip (32) has a deformable and adjustable alloy material built therein, so that the helix positioning strip (32) can be adjusted according to the curvature and angle of the patient's helix after surgery.

9. The ear protector according to claim 1, characterized in that The skull-ear angle bracket (4) comprises a main body portion (41) and a round hook portion (42); The main body (41) is arranged between the back of the ear and the skull of the patient to support the ear and prevent it from collapsing and deforming after surgery; The circular hook portion (42) is hung on the patient's ear to assist in fixation and protection.

10. The ear protector according to claim 1, characterized in that The arc-shaped protective bracket (2) includes multiple models, and the arc-shaped protective brackets (2) of different models have different degrees of encirclement. The arc-shaped protective brackets (2) of different models are matched with the protective covers (1) of corresponding models; The helix positioning bracket (3) comprises a plurality of models, and the helix positioning brackets (3) of different models have different lengths; The skull-ear angle bracket (4) includes multiple models, and different models of the skull-ear angle bracket (4) have different support angles.

Images