Ear orthosis and method for making the same

Abstract

The present invention provides an ear orthosis and a preparation method thereof. The ear orthosis provided by the present invention comprises an inner lining layer and a retainer, wherein a first area of ​​the inner surface of the inner lining layer covers a diseased area of ​​the auricle; the retainer is used to make the first area fit the diseased area of ​​the auricle and apply a preset pressure to the diseased area of ​​the auricle; and the hardness of the retainer is greater than the hardness of the inner lining layer. The ear orthosis provided by the present invention has high comfort.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an ear orthosis and a preparation method thereof. Background Art

[0002] Auricular deformity refers to the deformity of the auricle or other abnormal structures of the ear, whether congenital or acquired. Traditionally, auricular deformity is usually treated surgically, which is difficult and can directly cause damage to the patient. In addition, it is also easy to cause postoperative infection, unsightly recovery, and secondary recurrence.

[0003] In order to overcome the defects of traditional surgical treatment, in recent years, an ear orthosis has appeared in the field of medical devices, which can repair the patient's ear without surgery. Most of the existing ear orthoses are manufactured by reverse molding and injection molding.

[0004] Therefore, when using existing ear orthoses to treat and correct patients' ears, not only is the low degree of personalization resulting in high costs, but in order to ensure that the ear orthosis has sufficient strength to achieve ear correction, its hardness is usually large, resulting in low wearing comfort of the ear orthosis. Summary of the invention

[0005] The embodiments of the present invention provide an ear orthosis and a preparation method thereof, which can improve the comfort of the ear orthosis.

[0006] In one aspect, the present invention provides an ear orthosis, comprising: an inner lining layer and a retainer, wherein a first area of ​​an inner surface of the inner lining layer covers a diseased area of ​​an auricle;

[0007] The retainer is used to make the first area fit the diseased area of ​​the auricle and apply a preset pressure to the diseased area of ​​the auricle; and the hardness of the retainer is greater than the hardness of the lining layer.

[0008] As an optional embodiment, the shape of the inner surface of the lining layer matches the shape of the auricle, and the first area is an area of ​​the inner surface of the lining layer that is directly opposite to the diseased area of ​​the auricle.

[0009] As an optional embodiment, the edge of the lining layer is extended by at least 0.5 mm relative to the edge of the diseased area of ​​the auricle.

[0010] As an optional implementation, the first region is coated with drugs, or drugs are added to the material of the lining layer located in the first region.

[0011] As an optional embodiment, the shape of the inner surface of the retainer matches the shape of the outer surface of the inner lining layer, and the area of ​​the inner surface of the retainer facing the diseased area of ​​the auricle is in contact with the inner lining layer.

[0012] As an optional implementation, the lining layer is detachably connected to the retainer.

[0013] As an optional embodiment, the retainer includes a first clamping member, a second clamping member, and an adjustment assembly for connecting the first clamping member and the second clamping member.

[0014] As an optional implementation, the adjustment assembly includes a first connecting member, and the first connecting member is connected to the first clamping member and the second clamping member respectively.

[0015] As an optional embodiment, the adjustment assembly also includes a first reinforcing rib and a second reinforcing rib, the first reinforcing rib is arranged on the outer surface of the first clamping member, the second reinforcing rib is arranged on the outer surface of the second clamping member, and the first connecting member is respectively connected to the first reinforcing rib and the second reinforcing rib.

[0016] As an optional implementation, the first connecting member is a coil spring, and the coil spring is used to elastically connect the first clamping member and the second clamping member.

[0017] As an optional implementation, the first connecting member includes a first fastener, and the first fastener is used to detachably connect the first clamping member and the second clamping member.

[0018] As an optional implementation, the first fastener is one or more of a buckle, a bolt, and a ball.

[0019] As an optional embodiment, the first connecting member also includes a pair of ball heads and retaining cavities, the retaining cavities are arranged corresponding to the ball heads, and the ball heads are hinged to the retaining cavities, the ball heads are arranged on one of the ends of the first clamping member and the ends of the second clamping member, and the retaining cavity is arranged on the other of the ends of the first clamping member and the ends of the second clamping member.

[0020] As an optional embodiment, the adjustment component includes an adjustment member and a second connecting member, the second connecting member connects the first clamping member and the second clamping member to adjust the clamping force between the first clamping member and the second clamping member; the adjustment member connects the first clamping member and the second clamping member to adjust the distance between the first clamping member and the second clamping member.

[0021] As an optional embodiment, the adjusting member includes a first pressing portion connected to the outer surface of the first clamping member, a second pressing portion connected to the outer surface of the second clamping member, and a rotating connection portion arranged between the first pressing portion and the second pressing portion, and the first pressing portion and the second pressing portion are rotatably connected through the rotating connection portion.

[0022] As an optional embodiment, the rotating connection portion includes a protrusion and a groove that are matched and relatively rotatable, one of the protrusion and the groove is provided on the first pressing portion, and the other of the protrusion and the groove is provided on the second pressing portion.

[0023] As an optional embodiment, the rotating connection portion also includes a first transition connection portion connected between the first clamping member and the first pressing portion, and a second transition connection portion connected between the second clamping member and the second pressing portion, one of the protrusion and the groove is arranged on the surface of the first transition connection portion facing the second transition connection portion, and the other of the protrusion and the groove is arranged on the surface of the second transition connection portion facing the first transition connection portion.

[0024] As an optional implementation, a plurality of first anti-slip structures are arranged at intervals on a surface of the first pressing portion facing away from the second pressing portion, and a plurality of second anti-slip structures are arranged at intervals on a surface of the second pressing portion facing away from the first pressing portion.

[0025] As an optional implementation, the first anti-slip structure and the second anti-slip structure both include anti-slip grooves and / or anti-slip ridges.

[0026] As an optional embodiment, the second connecting member is an annular retaining spring with an opening, one end of the annular retaining spring is connected to the first transition connection part, and the other end of the annular retaining spring is connected to the second transition connection part to adjust the clamping force between the first clamping member and the second clamping member.

[0027] As an optional embodiment, the first transition connection part and the second transition connection part are both provided with a first mounting groove, the first pressing part and the second pressing part are both provided with a second mounting groove, and the opening ends of the annular retaining ring respectively pass through the second mounting grooves and are fixedly connected to the first mounting grooves.

[0028] As an optional embodiment, the second connecting member includes a second bolt and a second nut, the first transition connection part and the second transition connection part are both provided with a bolt mounting groove, the second bolt passes through the bolt mounting groove in the first transition connection part and the bolt mounting groove in the second transition connection part, and is threadedly connected to the second nut.

[0029] As an optional implementation, the first transition connection portion and the first pressing portion are detachably connected, and the second transition connection portion and the second pressing portion are detachably connected.

[0030] As an optional implementation, the adjustment assembly includes a mounting portion and a magnetic member;

[0031] The mounting portion includes a first mounting portion disposed on the outer surface of the first clamping member, and a second mounting portion disposed on the outer surface of the second clamping member;

[0032] The magnetic component includes a first magnetic component arranged on the first installation portion, and a second magnetic component arranged on the second installation portion, and the first magnetic component and the second magnetic component are attracted to each other.

[0033] As an optional implementation, a plurality of first mounting portions are provided at intervals on the outer surface of the first clamping member, and a plurality of second mounting portions are provided at intervals on the outer surface of the second clamping member, and the plurality of second mounting portions correspond one-to-one to the plurality of first mounting portions.

[0034] As an optional embodiment, the adjustment component further includes an elastic band, which is wound around the first mounting portion and the second mounting portion, and / or the elastic band is wound around the first magnetic member and the second magnetic member.

[0035] In another aspect, the present invention provides a method for preparing an ear orthosis, comprising the following steps:

[0036] Acquire an auricle model, wherein the auricle model includes at least one lesion area;

[0037] generating an inner lining layer model according to the auricle model, wherein the shape of the inner surface of the inner lining layer model matches the outer surface of the auricle model, and the inner surface of the inner lining layer model covers the lesion area of ​​the auricle model;

[0038] Generate a retainer model according to the lining layer model, wherein the retainer model is wrapped around the outer side of the lining layer model, and at least a portion of the retainer model is in contact with the lining layer model to generate a preset pressure in the lesion area of ​​the auricle model;

[0039] Three-dimensional printing is performed according to the lining layer model and the retainer model to obtain an ear orthosis including the lining layer and the retainer, wherein the hardness of the retainer is greater than the hardness of the lining layer.

[0040] As an optional implementation, the step of generating the lining layer model according to the auricle model includes:

[0041] Along the normal direction of the outer surface of the auricle model, stretching the outer surface of the auricle model by a first distance in a direction away from the auricle model to obtain an initial lining layer model;

[0042] On the inner surface of the diseased area of ​​the initial lining layer model corresponding to the auricle model, the inner surface of the diseased area of ​​the initial lining layer model corresponding to the auricle model is stretched a second distance toward the auricle model along the normal direction of the inner surface of the initial lining layer model to generate the lining layer model.

[0043] As an optional implementation, the step of generating the lining layer model according to the auricle model includes:

[0044] Repair the auricle model;

[0045] The outer surface of the repaired auricle model is stretched a first distance in a direction away from the auricle model to obtain an inner lining layer model.

[0046] As an optional implementation, the first distance ranges from 1 mm to 2 mm, and the second distance ranges from 0.3 mm to 0.8 mm.

[0047] As an optional implementation, the step of generating a retainer model according to the lining layer model includes:

[0048] Along the normal direction of the outer surface of the lining layer model, the outer surface of the lining layer model corresponding to the diseased area of ​​the auricle model is stretched a third distance in a direction away from the lining layer model to obtain a retainer model.

[0049] As an optional implementation, after generating the retainer model according to the lining layer model, the method further includes:

[0050] Segmenting the retainer model to obtain a first clamping piece model and a second clamping piece model;

[0051] An adjusting component model connected between the first clamping component model and the second clamping component model is obtained, and the adjusting component model and the first clamping component model, and the adjusting component model and the second clamping component model are combined.

[0052] In the ear orthosis provided by the present invention and the preparation method thereof, the ear orthosis comprises: an inner lining layer and a retainer, wherein the first area of ​​the inner surface of the inner lining layer covers the diseased area of ​​the auricle; the retainer is used to make the first area fit the diseased area of ​​the auricle and apply a preset pressure to the diseased area of ​​the auricle; and the hardness of the retainer is greater than the hardness of the inner lining layer. The hardness of the inner lining layer in the ear orthosis provided by the present invention is less than the hardness of the retainer, so that the comfort of the patient wearing the ear orthosis of the present invention can be improved while ensuring that the ear orthosis has sufficient strength.

[0053] The construction of the present invention and other objects and advantageous effects thereof will become more apparent through the description of the preferred embodiments in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0055] Figure 1a A diagram showing a first ear orthosis in use according to an embodiment of the present invention;

[0056] Figure 1b for Figure 1a Side view of

[0057] Figure 2a An exploded view of a second ear orthosis provided by an embodiment of the present invention;

[0058] Figure 2b for Figure 2a Schematic diagram of the local structure;

[0059] Figure 2c A schematic diagram of a connection state of a first clamping member and a second clamping member in a second ear orthosis provided by an embodiment of the present invention;

[0060] Figure 3a A diagram showing a usage state of a third ear orthosis provided by an embodiment of the present invention;

[0061] Figure 3b A schematic structural diagram of a third ear orthosis provided by an embodiment of the present invention;

[0062] Figure 4a A diagram showing a fourth ear orthosis in use according to an embodiment of the present invention;

[0063] Figure 4b An exploded view of a fourth ear orthosis provided by an embodiment of the present invention;

[0064] Figure 4c A schematic structural diagram of a fourth ear orthosis provided by an embodiment of the present invention;

[0065] Figure 4d Another structural schematic diagram of the fourth ear orthosis provided by an embodiment of the present invention;

[0066] Figure 5a A diagram showing a fifth ear orthosis in use according to an embodiment of the present invention;

[0067] Figure 5b A structural diagram of a fifth ear orthosis provided by an embodiment of the present invention;

[0068] Figure 5c Another structural schematic diagram of the fifth ear orthosis provided by an embodiment of the present invention;

[0069] Figure 6a A flowchart of the steps of a method for preparing an ear orthosis provided by an embodiment of the present invention;

[0070] Figure 6b A flow chart of the steps of generating an inner lining layer model according to an auricle model in a method for preparing an ear orthosis provided by an embodiment of the present invention;

[0071] Figure 6c A flow chart of another step of generating an inner lining layer model according to an auricle model in the method for preparing an ear orthosis provided by an embodiment of the present invention;

[0072] Figure 6d A flowchart of the steps of segmenting a retainer model and obtaining an adjustment component model in a method for preparing an ear orthosis provided by an embodiment of the present invention;

[0073] Figure 6e A flowchart of the steps of performing three-dimensional printing according to the lining layer model and the retainer model in the method for preparing the ear orthosis provided in an embodiment of the present invention to obtain the ear orthosis including the lining layer and the retainer;

[0074] Figure 6f A flow chart of the steps of obtaining an auricle model in the method for preparing an ear orthosis provided in an embodiment of the present invention.

[0075] Description of reference numerals:

[0076] 1- lining layer; 2- holder; 21- first clamping member; 211- first slot; 22- second clamping member; 221- second slot; 23- through hole; 3- adjusting assembly; 31a- first connecting member; 31b- second connecting member; 311b- second bolt; 312b- second nut; 311a- first fastener; 3111a- clamping convex; 3111b- clamping ball; 3112- transition connecting member; 312a- retaining cavity; 313a- ball head; 32- first reinforcing rib; 33- second reinforcing rib; 34- adjusting member; 341- first pressing portion; 3411- first plug-in column; 342- second pressing portion; 3421- second plug-in column; 343-rotating connection part; 3431-protrusion; 3432-groove; 3433-first transition connection part; 34331-first plug-in slot; 3434-second transition connection part; 34341-second plug-in slot; 3435-first mounting slot; 3436-second mounting slot; 3437-bolt mounting slot; 34371-external slot; 34372-internal slot; 344-first anti-slip structure; 345-second anti-slip structure; 346a-anti-slip groove; 346b-anti-slip ridge; 35-mounting part; 351-first mounting part; 352-second mounting part; 36-magnetic member; 361-first magnetic member; 362-second magnetic member. DETAILED DESCRIPTION

[0077] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments.

[0078] Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. In the absence of conflict, the following embodiments and features in the embodiments can be combined with each other.

[0079] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0080] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0081] It should be noted that in the description of the present invention, the terms "first" and "second" are only used to facilitate the description of different components, and cannot be understood as indicating or implying a sequential relationship, relative importance, or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features.

[0082] There are many types of auricular deformities, including congenital and acquired. Congenital auricular deformities are mainly caused by genetics or viral infection during the mother's pregnancy, while acquired auricular deformities may be caused by trauma or infection. Traditional auricular deformities are usually treated surgically, which is difficult and will directly cause damage to the patient. In addition, it is easy to cause postoperative infection, unsightly recovery, secondary recurrence and other problems.

[0083] In order to overcome the defects of traditional surgical treatment, in recent years, an ear orthosis has appeared in the field of medical devices, which can repair the patient's ear without surgery. Most of the existing ear orthoses are manufactured by reverse molding and injection molding, making them mostly one-piece devices.

[0084] Therefore, the existing ear orthosis has the following defects during use:

[0085] First, the existing ear orthoses are too hard, and patients will feel strong discomfort during the treatment process after wearing them;

[0086] Second, most existing ear orthoses are integrally formed. Therefore, when different patients use them or the ear condition of the patient changes later, the ear orthosis cannot be adjusted and needs to be replaced with a new ear orthosis for treatment.

[0087] Therefore, the present invention provides an ear orthosis and a preparation method thereof, which can overcome the above-mentioned defects.

[0088] Different types of ear orthoses are described below using scar hyperplasia and ear retraction as examples in conjunction with relevant drawings and specific embodiments.

[0089] It should be noted that scar hyperplasia refers to the result of excessive repair of fibrous tissue after the body is traumatized, which is specifically manifested as raised plaques, tumors, etc.; ring-shaped ear is mainly caused by the tightening of the auricle due to insufficient length of the periphery. When patients with scar hyperplasia use the ear orthosis provided by the invention, the ear orthosis of the invention can play a role in repairing and shaping; when patients with ring-shaped ear use the ear orthosis provided by the invention, the ear orthosis of the invention can play a role in shaping.

[0090] Figure 1a This is a diagram of the usage status of the first ear orthosis provided by an embodiment of the present invention. Figure 1b for Figure 1a Side view of. Figure 2a A schematic structural diagram of a second ear orthosis provided in an embodiment of the present invention. Figure 2b for Figure 2a Schematic diagram of the local structure. Figure 2c A schematic diagram of a connection state of a first clamping member and a second clamping member in a second ear orthosis provided by an embodiment of the present invention. Figure 3a This is a diagram of the usage status of the third ear orthosis provided by an embodiment of the present invention. Figure 3b A schematic structural diagram of a third ear orthosis provided in an embodiment of the present invention. Figure 4a This is a diagram of the usage status of the fourth ear orthosis provided by an embodiment of the present invention. Figure 4b An exploded view of a fourth ear orthosis provided by an embodiment of the present invention. Figure 4c A schematic structural diagram of a fourth ear orthosis provided in an embodiment of the present invention. Figure 4d This is another schematic structural diagram of the fourth ear orthosis provided by an embodiment of the present invention. Figure 5a This is a diagram of the usage status of the fifth ear orthosis provided by an embodiment of the present invention. Figure 5b This is a structural diagram of a fifth ear orthosis provided in an embodiment of the present invention. Figure 5c This is another schematic structural diagram of the fifth ear orthosis provided by an embodiment of the present invention.

[0091] like Figures 1a to 5c As shown, this embodiment provides an ear orthosis, including: an inner lining layer 1 and a retainer 2, wherein a first area of ​​the inner surface of the inner lining layer 1 covers the diseased area of ​​the auricle, and the inner lining layer 1 and the retainer 2 are detachably connected; the retainer 2 is used to make the first area fit the diseased area of ​​the auricle and apply a preset pressure to the diseased area of ​​the auricle; and the hardness of the retainer 2 is greater than the hardness of the inner lining layer.

[0092] It should be noted that the lining layer 1 and the retainer 2 in the ear orthosis provided in this embodiment are both printed by three-dimensional printing technology.

[0093] Specifically, the lining layer 1 and the retainer 2 can be integrally printed by a 3D printer, or can be separately printed by a 3D printer and then assembled for use.

[0094] It should be noted that the assembly method between the lining layer 1 and the retainer 2 is not specifically limited here.

[0095] The ear orthosis provided in the present embodiment is provided with a detachably connected inner lining layer 1 and a retainer 2. Therefore, by replacing different inner lining layers 1, the ear orthosis provided in the present embodiment can be suitable for different patients, thereby expanding the scope of application of the ear orthosis provided in the present embodiment. Moreover, during the treatment and repair of the patient's ear, the inner lining layer 1 can also be replaced as the patient's ear condition changes, thereby making the ear orthosis provided in the present embodiment more conducive to correcting the patient's ear and reducing the cost of treatment.

[0096] It should be noted that when a patient suffering from scar hyperplasia uses the ear orthosis provided in this embodiment, the retainer 2 can exert pressure on the diseased area of ​​the ear, thereby inhibiting the growth of scar hyperplasia; when a patient suffering from ring-shaped ear uses the ear orthosis provided in this embodiment, the inner lining layer 1 can provide a shaping space for the ring-shaped ear after repair, so that the patient's ear can be later repaired and shaped according to the shaping space. In order to improve the comfort of the ear orthosis provided in this embodiment, in this embodiment, the inner lining layer 1 is made of a flexible material and the retainer 2 is made of a hard material. In this way, the diseased area of ​​the auricle is in contact with the flexible inner lining layer 1, thereby improving the comfort of the ear orthosis provided in this embodiment.

[0097] Optionally, the lining layer 1 is made of a flexible photosensitive resin material; and the retainer 2 is made of a hard photosensitive resin material.

[0098] It should be noted that as long as the lining layer 1 and the retainer 2 are both made of biocompatible materials, the purpose of this embodiment can be achieved. Here, there is no limitation on other types of materials used to make the lining layer 1 and the retainer 2.

[0099] Specifically, since the lining layer 1 is formed of a flexible material and the retainer 2 is formed of a hard material, when the 3D printer is a multi-material 3D printer, that is, the 3D printer can print flexible materials and hard materials at the same time, the lining layer 1 and the retainer 2 can be printed as one piece; when the 3D printer is a single-material 3D printer, that is, the 3D printing can only print one material, the lining layer 1 and the retainer 2 can be printed separately and then assembled for use.

[0100] It should be noted that, in order to save printing time, different 3D printers may be used to print the lining layer 1 and the retainer 2 at the same time.

[0101] In a specific implementation of this embodiment, the 3D printer can be a 3D printer based on any one of fused deposition modeling technology, stereolithography technology, selective laser sintering technology, selective laser melting technology, 3D inkjet molding technology and jet melting molding technology.

[0102] In order to improve the orthopedic effect of the ear orthosis provided in this embodiment, in this embodiment, the inner surface shape of the lining layer 1 matches the shape of the auricle, and the first area is the area on the inner surface of the lining layer 1 that is opposite to the diseased area of ​​the auricle.

[0103] In this way, the diseased area of ​​the ear can be set corresponding to the first area, thereby improving the orthopedic effect of the ear orthosis.

[0104] In order to further ensure that the ear orthosis completely covers the lesion area, in this embodiment, along the extension direction of the auricle surface, the edge of the inner lining layer 1 is extended by at least 0.5 mm relative to the edge of the lesion area of ​​the auricle. Specifically, when the edge of the inner lining layer 1 is extended by a certain distance relative to the edge of the lesion area of ​​the auricle, it can be ensured that the inner lining layer 1 completely covers the lesion area, avoiding the phenomenon that the edge of the lesion area cannot be covered by the inner lining layer 1, thereby improving the repair effect of the ear orthosis provided by this embodiment.

[0105] In order to prevent the diseased area from deforming in other directions, in the present embodiment, along the direction perpendicular to the surface of the auricle, the edge of the lining layer 1 is extended by at least 0.5 mm relative to the edge of the diseased area of ​​the auricle. Specifically, the edge of the lining layer 1 can form a blocking portion at the opening of the lining layer 1. When the patient wears the ear orthosis provided by the present embodiment, the ear orthosis will exert force on the diseased area, causing the diseased area to extend in a direction perpendicular to the force direction. After a long time, in order to prevent the above-mentioned extension from evolving into deformity, the edge of the lining layer 1 can resist the end of the auricle along the extension direction. In this way, secondary deformity of the ear can be avoided.

[0106] In a specific implementation of this embodiment, the edge of the lining layer 1 is extended by 1 mm relative to the edge of the lesion area of ​​the auricle.

[0107] In order to further enhance the orthopedic effect of the ear orthosis and reduce the cost of ear treatment, in this embodiment, the shape of the inner surface of the lining layer 1 is the same as the shape of the first region, and the area of ​​the inner surface of the lining layer 1 is equal to the area of ​​the first region.

[0108] In this way, the inner surface of the lining layer 1 is exactly arranged opposite to the diseased area, so that the diseased area can be repaired according to the shape of the inner surface of the lining layer 1, thereby ensuring the orthotic effect of the ear orthosis. In addition, when the inner surface of the lining layer 1 only corresponds to the diseased area, the lining layer 1 occupies a smaller space, thereby reducing the manufacturing cost of the ear orthosis and thus reducing the cost of ear treatment.

[0109] In order to make the ear orthosis provided in this embodiment have a therapeutic effect in addition to the orthotic effect, in this embodiment, the first area is coated with drugs, or drugs are added to the material of the lining layer 1 located in the first area.

[0110] In this way, the medicine can play a therapeutic role on the diseased area of ​​the ear, so that the ear orthosis provided in this embodiment can also play a therapeutic role in the process of ear correction, which is beneficial to the repair of the ear.

[0111] In order to enable the retainer 2 to effectively apply force to the diseased area and facilitate the repair of the diseased area, in this embodiment, the inner surface shape of the retainer 2 matches the outer surface shape of the lining layer 1, and the area of ​​the inner surface of the retainer 2 that is opposite to the diseased area of ​​the auricle is in contact with the lining layer 1.

[0112] In this way, the area on the inner surface of the retainer 2 that is opposite to the diseased area of ​​the auricle can effectively contact the lining layer 1, so that the retainer 2 can effectively exert force on the lining layer 1, and then exert force on the diseased area, thereby inhibiting the growth of scar hyperplasia in the diseased area.

[0113] In this embodiment, the retainer 2 includes a first clamping member 21 and a second clamping member 22 , and an adjustment assembly 3 for connecting the first clamping member 21 and the second clamping member 22 .

[0114] In this way, the relative position between the first clamping member 21 and the second clamping member 22 can be adjusted by the adjustment component 3, so that the retainer 2 can be adjusted according to the repair state of the patient's ear, which is beneficial to the correction of the ear.

[0115] Optionally, the first clamping member 21 and the second clamping member 22 are both sheet-like structures, which can reduce the weight of the retainer 2 and facilitate the patient to wear the ear orthosis provided in this embodiment.

[0116] In a specific implementation of this embodiment, the first clamping member 21 and the second clamping member 22 are both provided with an inner lining layer 1 .

[0117] In this way, it can be ensured that both the diseased area and the non-lesioned area of ​​the ear are in contact with the inner lining layer 1, thereby improving the comfort of the patient wearing the ear orthosis provided by this embodiment.

[0118] like Figures 1a to 2c As shown, in this embodiment, the adjustment component 3 includes a first connecting member 31a, and the first connecting member 31a is respectively connected to the first clamping member 21 and the second clamping member 22. In this way, the first clamping member 21 and the second clamping member 22 can be connected through the first connecting member 31a to clamp the patient's ear, so that the patient can wear the ear orthosis provided by this embodiment.

[0119] In order to improve the strength and rigidity of the retainer 2, in this embodiment, the adjustment assembly 3 also includes a first reinforcing rib 32 and a second reinforcing rib 33, the first reinforcing rib 32 is arranged on the outer surface of the first clamping member 21, the second reinforcing rib 33 is arranged on the outer surface of the second clamping member 22, and the first connecting member 31a is respectively connected to the first reinforcing rib 32 and the second reinforcing rib 33.

[0120] In this way, by providing the first reinforcing rib 32 and the second reinforcing rib 33, the strength and rigidity of the first clamp 21 and the second clamp 22 can be enhanced, and then the strength and rigidity of the retainer 2 can be enhanced, so that the retainer 2 can effectively support the lining layer 1, and can ensure that the retainer 2 effectively applies force to the diseased area, which is beneficial to the repair and shaping of the ear.

[0121] In this embodiment, the extension direction of the first reinforcing rib 32 is consistent with the extension direction of the first clamping member 21 on the outer surface of the auricle, and the extension direction of the second reinforcing rib 33 is consistent with the extension direction of the second clamping member 22 on the outer surface of the auricle. In this way, the first clamping member 21 and the second clamping member 22 are easily processed.

[0122] like Figure 1a and Figure 1b As shown, in some embodiments, the first connecting member 31a is a coil spring, and the coil spring is used to elastically connect the first clamping member 21 and the second clamping member 22. Specifically, the coil spring is used to elastically connect the first reinforcing rib 32 and the second reinforcing rib 33.

[0123] It should be noted that the coil spring can be integrally printed with the first clamping member 21 and the second clamping member 22 .

[0124] In a specific implementation of this embodiment, the first clamping member 21 and the second clamping member 22 are both irregular curved sheet structures.

[0125] As an optional implementation of this embodiment, the first reinforcing rib 32 and the second reinforcing rib 33 are semi-cylindrical structures with a cross-sectional diameter range of 2 mm-3 mm. In this way, the shapes of the first reinforcing rib 32 and the second reinforcing rib 33 are more compatible with the first clamping member 21 and the second clamping member 22, making it easier to print the retainer 2.

[0126] In some embodiments, there may be multiple coil springs, and the position of the coil springs may be determined according to the position of the lesion area. Typically, the coil springs may be set corresponding to the lesion area, and the setting density of the coil springs and the elastic coefficient of the coil springs may be determined based on a preset pressure. Specifically, the setting density of the coil springs may be increased or the elastic coefficient of the coil springs may be increased in areas where the lesions are more severe, wherein the elastic coefficient of the coil spring is related to parameters such as the material and size of the coil spring. That is, parameters such as the setting density, material and size of the coil spring may be determined based on a preset pressure.

[0127] Further, when the preset pressure is relatively small, the coil spring can be integrally formed with the holder 2 by printing, and the coil spring is formed of a hard elastic material; when the preset pressure is relatively large, due to the limitation of the material, when the first clamping member 21, the second clamping member 22 and the coil spring are obtained based on the same three-dimensional molding technology, the coil spring may not meet the requirements of the preset pressure, so the coil spring can be formed independently of the first clamping member 21 and the second clamping member 22. Specifically, it can be independently formed based on printing, or it can be obtained based on other methods other than printing, and this embodiment does not limit this.

[0128] In some embodiments, in order to meet a larger preset pressure requirement, the coil spring may be formed of a metal material.

[0129] In a specific implementation of this embodiment, the coil spring may be a spiral structure obtained by spiraling a cylinder. Specifically, the diameter of the cylinder may range from 1 mm to 3 mm, the diameter of the spiral structure may range from 3 mm to 5 mm, and the pitch of the spiral structure may range from 2 mm to 4 mm.

[0130] When using the ear orthosis provided in this embodiment, first, fix the patient's ear, slowly stretch the lining layer 1 and the retainer 2 and put them on the patient's ear. During the treatment, since the first clamp 21 and the second clamp 22 are connected by a coil spring, when the shape of the ear changes during the correction process, the distance between the first clamp 21 and the second clamp 22 can be close to each other under the elastic force of the coil spring, so that the first clamp 21 and the second clamp 22 can continue to apply a preset pressure to the surface of the auricle; if the first clamp 21 and the second clamp 22 are connected by a coil spring, when part of the diseased area of ​​the patient returns to normal, part of the coil spring can be removed to reduce the pressure in the area that has returned to normal.

[0131] like Figure 2a to Figure 2c As shown, in some other embodiments, the first connecting member 31 a includes a first fastening member 311 a , and the first fastening member 311 a is used to detachably connect the first clamping member 21 and the second clamping member 22 .

[0132] In this way, the first clamping member 21 and the second clamping member 22 are connected together by the first fastener 311a to achieve a detachable connection between the first clamping member 21 and the second clamping member 22, so that the patient can adjust the retainer 2 according to the repair state of the ear.

[0133] In this embodiment, there are a plurality of first fasteners 311 a , and the plurality of first fasteners 311 a are distributed at intervals at the junction of the first clamping member 21 and the second clamping member 22 .

[0134] In this embodiment, the first fastener 311a is one or more of a buckle, a bolt, and a ball. The following describes the three cases where the first fastener 311a is a buckle, the first fastener 311a is a bolt, and the first fastener 311a is a ball.

[0135] like Figure 2a As shown, as an optional embodiment, the first fastener 311a is a buckle, the outer surface of the first clamping member 21 is provided with a first slot 211 that is snap-connected to one end of the buckle 311, and the outer surface of the second clamping member 22 is provided with a second slot 221 that is snap-connected to the other end of the buckle.

[0136] In a specific implementation of this embodiment, the buckle 311 is a "U"-shaped part, and both side arms of the buckle 311 have a latching protrusion 3111a. The two latching protrusions 3111a are arranged opposite to each other, and the two latching protrusions 3111a correspond one-to-one to the first latching groove 211 and the second latching groove 221. The two latching protrusions 3111a can be respectively engaged with the first latching groove 211 and the second latching groove 221, so that the buckle 311 connects the first clamping member 21 with the second clamping member 22.

[0137] Optionally, the first card slot 211 and the second card slot 221 are both rectangular. It should be noted that the first card slot 211 and the second card slot 221 may also be other shapes, and other shapes of the first card slot 211 and the second card slot 221 are not specifically limited here.

[0138] As another optional embodiment, the first fastener 311a is a matching bolt and nut, the outer surface of the first clamping member 21 is provided with a first through hole, the outer surface of the second clamping member 22 is provided with a second through hole, the bolt passes through the first through hole and the second through hole and is connected to the nut, thereby connecting the first clamping member 21 and the second clamping member 22 together.

[0139] In this embodiment, a plurality of first through holes distributed at intervals can be set on the outer surface of the first clamping member 21, and a plurality of second through holes distributed at intervals can be set on the outer surface of the second clamping member 22, and the plurality of second through holes correspond one-to-one to the plurality of first through holes. In this way, not only can a reliable connection between the first clamping member 21 and the second clamping member 22 be achieved, but also, when the patient's ear repair state changes, the retainer 2 can be adjusted by adding bolts and nuts or removing redundant bolts and nuts, so that the ear orthosis provided in this embodiment can better correct the patient's ears.

[0140] like Figure 2c As shown, as another optional embodiment, the first fastener 311a includes two relatively and staggered locking balls 3111b, one locking ball 3111b is set on the first clamping member 21, and the other locking ball 3111b is set on the second clamping member 22, and one locking ball 3111b can pass over the other locking ball 3111b and abut against the other locking ball 3111b.

[0141] In this embodiment, the ball 3111b is connected to the first clamping member 21 or the second clamping member 22 through a transition connector 3112. Specifically, the transition connector 3112 may be an L-shaped rod structure, so that one side arm of the transition connector 3112 is connected to the first clamping member 21 or the second clamping member 22, and the end of the other side arm of the transition connector 3112 is connected to the ball 3111b.

[0142] In a specific implementation, by pressing the two locking balls 3111b, the two locking balls 3111b are moved relative to each other. When one locking ball 3111b passes over the other locking ball 3111b and abuts against the other locking ball 3111b, the connection between the first clamping member 21 and the second clamping member 22 can be achieved.

[0143] In order to facilitate the positioning of the first clamping member 21 and the second clamping member 22 and to facilitate the wearing of the ear orthosis provided in this embodiment, in this embodiment, the first connecting member 31a also includes a pair of ball heads 313a and retaining cavities 312a, the retaining cavities 312a and the ball heads 313a are arranged corresponding to each other, and the ball heads 313a and the retaining cavities 312a are hingedly connected, the ball heads 313a are arranged on one of the ends of the first clamping member 21 and the ends of the second clamping member 22, and the retaining cavities 312a are arranged on the other of the ends of the first clamping member 21 and the ends of the second clamping member 22.

[0144] In this embodiment, the first connecting member 31a includes two ball heads 313a and two retaining cavities 312a, and the two ball heads 313a and the two retaining cavities 312a are respectively arranged at the two ends of the first clamping member 21 and the second clamping member 22 to hinge the first clamping member 21 and the second clamping member 22; wherein, the ball head 313a and the retaining cavity 312a are matched with each other in a clearance fit manner, that is, when the ball head 313a is located in the retaining cavity 312a, the first clamping member 21 and the second clamping member 22 can rotate relative to each other, so as to facilitate the adjustment of the angle between the first clamping member 21 and the second clamping member 22.

[0145] Optionally, the ball head 313a is a spherical structure with a diameter ranging from 4 mm to 8 mm, and the retention cavity 312a is a hemispherical cavity with an outer diameter ranging from 6 mm to 10 mm and an inner diameter ranging from 4 mm to 8 mm.

[0146] In order to facilitate the connection between the first connecting member 31a and the first clamping member 21 and the second clamping member 22 and ensure that the connection has sufficient strength, as shown in FIG. Figure 2a to Figure 2b As shown, in this embodiment, a first reinforcing rib 32 is provided at the edge of the outer surface of the first clamping member 21, a second reinforcing rib 33 is provided at the edge of the outer surface of the second clamping member 22, and a first connecting member 31a is connected to the first reinforcing rib 32 and the second reinforcing rib 33 respectively, so as to connect the first clamping member 21 and the second clamping member 22. Specifically, the first clamping groove 211 and the first through hole are provided on the first reinforcing rib 32, the second clamping groove 221 and the second through hole are provided on the second reinforcing rib 33, two clamping balls 3111b are respectively connected to the first reinforcing rib 32 or the second reinforcing rib 33 through a transition connecting member 3112, and the ball head 313a and the retaining cavity 312a are respectively provided at the end of the first reinforcing rib 32 and the end of the second reinforcing rib 33.

[0147] In a specific implementation of this embodiment, the extension direction of the first reinforcing rib 32 is consistent with the extension direction of the edge of the first clamping member 21 , and the extension direction of the second reinforcing rib 33 is consistent with the extension direction of the edge of the second clamping member 22 .

[0148] Optionally, the first reinforcing rib 32 and the second reinforcing rib 33 are both strip structures, and the extension length of the first reinforcing rib 32 and the second reinforcing rib 33 in the extension direction of the edges of the first clamp 21 and the second clamp 22 ranges from 6 mm to 12 mm, and the thickness of the first reinforcing rib 32 and the second reinforcing rib 33 can be consistent with the thickness of the first clamp 21 and the second clamp 22, which can range from 0.5 mm to 4 mm.

[0149] In order to reduce the weight of the ear orthosis provided in this embodiment and facilitate the patient to use the ear orthosis provided in this embodiment, in this embodiment, the lining layer 1, the first clamping member 21 and the second clamping member 22 are provided with a plurality of through holes 23, so that the weight of the ear orthosis can be reduced and the patient can use the ear orthosis provided in this embodiment. In addition, the air permeability of the ear orthosis provided in this embodiment can be improved, which is convenient for the repair of the ear diseased area.

[0150] When using the ear orthosis provided in this embodiment, first put the inner lining layer 1 on the patient's ear, then put the first clamping member 21 and the second clamping member 22 of the retainer 2 on the inner lining layer 1 respectively, insert the ball head 313a into the corresponding retention cavity 312a respectively, slowly rotate the first clamping member 21 and the second clamping member 22 and pinch the first reinforcing rib 32 and the second reinforcing rib 33, and fix the first clamping member 21 and the second clamping member 22 with the first fastener 311a; and, during the treatment process, if part of the patient's diseased area returns to normal, the patient can remove part of the first fastener 311a to reduce the pressure in the area that has returned to normal.

[0151] It should be noted that in the above embodiment, when the first fastener 311a is a buckle, the size of the buckle can change with the angle between the first clamp 21 and the second clamp 22, that is, with the thickness of the lesion area. That is, when the angle between the first clamp 21 and the second clamp 22 is a certain value, the buckle is also a buckle of fixed size.

[0152] like Figures 3a to 5c As shown, in some embodiments, the adjustment component 3 includes an adjustment member 34 and a second connecting member 31b, the second connecting member 31b connects the first clamping member 21 and the second clamping member 22 to adjust the clamping force between the first clamping member 21 and the second clamping member 22; the adjustment member 34 connects the first clamping member 21 and the second clamping member 22 to adjust the distance between the first clamping member 21 and the second clamping member 22.

[0153] In this way, by adjusting the distance between the first clamping member 21 and the second clamping member 22 to facilitate wearing of the ear orthosis, and by adjusting the clamping force between the first clamping member 21 and the second clamping member 22, the state of the retainer 2 can be changed to adapt to the state of the patient's ear at different repair stages.

[0154] Specifically, the adjusting member 34 includes a first pressing portion 341 connected to the outer surface of the first clamping member 21, a second pressing portion 342 connected to the outer surface of the second clamping member 22, and a rotating connecting portion 343 arranged between the first pressing portion 341 and the second pressing portion 342, and the first pressing portion 341 and the second pressing portion 342 are rotatably connected through the rotating connecting portion 343.

[0155] In this way, when the first pressing portion 341 and the second pressing portion 342 are pressed or released, the first pressing portion 341 and the second pressing portion 342 can be relatively rotated to adjust the distance between the first clamping member 21 and the second clamping member 22 .

[0156] Specifically, the first pressing portion 341 is connected to the edge of the outer surface of the first clamping member 21 , and the second pressing portion 342 is connected to the edge of the outer surface of the second clamping member 22 .

[0157] In some embodiments, the rotating connection portion 343 includes a matching and relatively rotatable protrusion 3431 and groove 3432 , one of the protrusion 3431 and the groove 3432 is disposed on the first pressing portion 341 , and the other of the protrusion 3431 and the groove 3432 is disposed on the second pressing portion 342 .

[0158] In this embodiment, the protrusion 3431 is a plate-like structure printed integrally with the first clamping member 21 or the second clamping member 22 , and the extension direction of the plate-like structure is consistent with the arrangement direction of the first clamping member 21 and the second clamping member 22 .

[0159] Specifically, the end of the protrusion 3431 can abut against the bottom of the groove 3432 .

[0160] In some embodiments, the rotating connection portion 343 also includes a first transition connection portion 3433 connected between the first clamping member 21 and the first pressing portion 341, and a second transition connection portion 3434 connected between the second clamping member 22 and the second pressing portion 342, one of the protrusion 3431 and the groove 3432 is arranged on the surface of the first transition connection portion 3433 facing the second transition connection portion 3434, and the other of the protrusion 3431 and the groove 3432 is arranged on the surface of the second transition connection portion 3434 facing the first transition connection portion 3433.

[0161] In this way, by providing the first transition connection portion 3433 and the second transition connection portion 3434, not only the structure of the first clamping member 21 and the second clamping member 22 can be strengthened, but also the extension length of the first clamping member 21 and the second clamping member 22 can be extended, making it easier for the patient to press or release the first pressing portion 341 and the second pressing portion 342.

[0162] like Figure 3a and Figure 3b As shown, in some embodiments, a plurality of first anti-slip structures 344 are disposed at intervals on the surface of the first pressing portion 341 facing away from the second pressing portion 342 , and a plurality of second anti-slip structures 345 are disposed at intervals on the surface of the second pressing portion 342 facing away from the first pressing portion 341 .

[0163] In this way, by providing a first anti-slip structure 344 on the first pressing part 341 and a second anti-slip structure 345 on the second pressing part 342, the friction between the patient's hand and the first pressing part 341 and the second pressing part 342 can be increased, thereby preventing the patient from being separated from the first pressing part 341 and the second pressing part 342 during the process of squeezing or releasing the first pressing part 341 and the second pressing part 342, thereby causing secondary damage to the patient's ears.

[0164] Optionally, the first anti-slip structure 344 and the second anti-slip structure 345 both include anti-slip grooves 346a and / or anti-slip ridges 346b.

[0165] Specifically, a plurality of anti-slip grooves 346a are arranged at intervals on the surface of the first pressing portion 341 facing away from the second pressing portion 342, and a plurality of anti-slip grooves 346a are arranged at intervals on the surface of the second pressing portion 342 facing away from the first pressing portion 341, and an anti-slip ridge 346b is formed between two adjacent anti-slip grooves 346a, and an extension direction of the anti-slip grooves 346a and the anti-slip ridge 346b on the plate surface of the first pressing portion 341 and the second pressing portion 342 is perpendicular to an extension direction of the first pressing portion 341 and the second pressing portion 342.

[0166] Optionally, the anti-slip groove 346a can be a groove with a semicircular cross-section shape, and the diameter of the semicircle ranges from 1 mm to 3 mm, and the spacing between two adjacent anti-slip grooves 346a ranges from 1 mm to 3 mm, that is, the width of the anti-slip ridge 346b ranges from 1 mm to 3 mm.

[0167] In some embodiments, the second connecting member 31b is an annular retaining spring with an opening, one end of which is connected to the first transition connecting portion 3433 or the first clamping member 21, and the other end of the annular retaining spring is connected to the second transition connecting portion 3434 or the second clamping member 22 to adjust the clamping force between the first clamping member 21 and the second clamping member 22.

[0168] Specifically, when the first pressing portion 341 and the second pressing portion 342 are pressed, the distance between the first clamping member 21 and the second clamping member 22 increases, so that the patient can wear the ear orthosis provided by this embodiment.

[0169] In order to limit the position of the annular retaining ring, in this embodiment, the first transition connection portion 3433 and the second transition connection portion 3434 are both provided with a first mounting groove 3435, and the first pressing portion 3433 and the second pressing portion 3434 are both provided with a second mounting groove 3436, and the two ends of the opening of the annular retaining ring respectively pass through the second mounting groove 3436 and are fixedly connected to the first mounting groove 3435.

[0170] Specifically, the extending direction of the first mounting groove 3435 is consistent with the extending direction of the anti-slip groove 346 a , and the extending direction of the second mounting groove 3436 is perpendicular to the extending direction of the first mounting groove 3435 .

[0171] In this way, by providing the second mounting groove 3436, the annular retaining spring can be prevented from moving in the first mounting groove 3435, thereby limiting the annular retaining spring.

[0172] Optionally, the width of the first mounting groove 3435 ranges from 2 mm to 3 mm, the depth ranges from 2 mm to 3 mm, and the length ranges from 10 mm to 20 mm, and the second mounting groove 3436 is a square hole, and the width of the square hole ranges from 2 mm to 3 mm, and the length ranges from 15 mm to 25 mm.

[0173] In this embodiment, the second connecting member 31b includes two annular retaining springs that are spaced apart to ensure that the clamping force between the first clamping member 21 and the second clamping member 22 is evenly distributed, thereby improving the comfort of the patient wearing the ear orthosis provided by this embodiment. In addition, by providing two annular retaining springs that are spaced apart, the relative positions of the first clamping member 21 and the second clamping member 22 can be adjusted, thereby simplifying the structure of the ear orthosis provided by this embodiment.

[0174] Optionally, the annular retaining spring is formed by bending a columnar component, and the cross-sectional diameter, annular diameter and material of the annular retaining spring can be determined based on a preset pressure.

[0175] It should be noted that the annular retaining spring can be integrally formed and printed with the first clamping member 21 and the second clamping member 22, or can be printed separately from the first clamping member 21 and the second clamping member 22, or can be formed by other methods, for example, the annular retaining spring is a metal annular retaining spring.

[0176] When using the ear orthosis provided in this embodiment, first, fix the inner lining layer 1 to the first clamping member 21 and the second clamping member 22, press the first pressing portion 341 and the second pressing portion 342 to increase the distance between the first pressing portion 341 and the second pressing portion 342, and expand the opening of the inner lining layer 1, so as to facilitate the patient to wear the ear orthosis provided in this embodiment. Moreover, since the shape of the ear will change during the correction process, the distance between the first clamping member 21 and the second clamping member 22 can be closer to each other under the action of the elastic force of the annular retaining spring, so that the first clamping member 21 and the second clamping member 22 can continue to apply pressure to the surface of the auricle, which is beneficial to the repair of the patient's ear.

[0177] like Figures 4a to 4d As shown, in other embodiments, the second connecting member 31b includes a second bolt 311b and a second nut 312b, and the first transition connection portion 3433 and the second transition connection portion 3434 are both provided with a bolt mounting groove 3437. The second bolt 311b passes through the bolt mounting groove 3437 in the first transition connection portion 3433 and the bolt mounting groove 3437 in the second transition connection portion 3434, and is threadedly connected to the second nut 312b.

[0178] In this way, after the ear orthosis is worn on the auricle by pressing the first pressing portion 341 and the second pressing portion 342, the first clamping member 21 and the second clamping member 22 can be fixed by the second bolt 311b and the second nut 312b. During the repair process, as the ear shape changes, the relative position between the first clamping member 21 and the second clamping member 22 can also be adjusted by adjusting the second bolt 311b.

[0179] In order to improve the appearance of the ear orthosis provided in this embodiment and prevent the patient's hand from touching the second bolt 311b, in this embodiment, the bolt mounting groove 3437 is a rectangular countersunk groove, and the bolt head of the second bolt 311b and the second nut 312b are located in the countersunk groove.

[0180] In this way, the bolt head of the second bolt 311b and the second nut 312b can be hidden in the bolt mounting groove 3437, which can not only improve the appearance of the ear orthosis provided by this embodiment, but also prevent the patient's head from touching the second bolt 311b, thereby avoiding injuries to the patient's hands.

[0181] Optionally, the second bolt 311b is a round head bolt made of metal, the diameter of the bolt head is in the range of 3 mm-5 mm, the thickness is in the range of 0.5 mm-2 mm, the diameter of the threaded part is in the range of 1 mm-2 mm, and the second nut 312b is a hexagonal nut made of metal, the thickness is 0.5 mm-2 mm, and the distance between opposite sides is in the range of 3 mm-5 mm. Accordingly, the bolt mounting groove 3437 includes an outer groove 34371 and an inner groove 34372. The outer groove 34371 can be a rectangular groove with a width range of 3 mm-5 mm, a length range of 10 mm-20 mm, and a depth range of 0.5 mm-2 mm. The inner groove 34372 can be a rectangular hole with a width range of 2 mm-3 mm and a length range of 10 mm-20 mm that passes through the first clamping member 21 and the second clamping member 22.

[0182] In order to reduce the weight of the ear orthosis provided by this embodiment, in a specific implementation manner of this embodiment, the first transition connection portion 3433 and the first pressing portion 341 are detachably connected, and the second transition connection portion 3434 and the second pressing portion 342 are detachably connected.

[0183] Specifically, when wearing, the first pressing portion 341 is installed on the first transition connection portion 3433, and the second pressing portion 342 is installed on the second transition connection portion 3434, so as to adjust the distance between the first clamping member 21 and the second clamping member 22 to facilitate the patient to wear the ear orthosis provided in this embodiment; when wearing is completed, the first pressing portion 341 and the second pressing portion 342 can be removed to reduce the weight of the ear orthosis and improve the comfort of the patient wearing the ear orthosis.

[0184] Specifically, the end of the first pressing portion 341 has two first plug-in columns 3411 that are spaced apart, and the end of the second pressing portion 342 has two second plug-in columns 3421 that are spaced apart. The first transition connection portion 3433 is provided with two first plug-in grooves 34331, and the second transition connection portion is provided with two second plug-in grooves 34341. The first plug-in groove 34331 is provided corresponding to the first plug-in column 3411, and the second plug-in groove 34341 is provided corresponding to the second plug-in column 3421. The first plug-in column 3411 can be inserted into the first plug-in groove 34331, and the second plug-in column 3421 can be inserted into the second plug-in groove 34341, so as to realize the detachable connection between the first transition connection portion 3433 and the first pressing portion 341 and the detachable connection between the second transition connection portion 3434 and the second pressing portion 342.

[0185] When using the ear orthosis provided in this embodiment, first, the inner lining layer 1 is fixed to the first clamping member 21 and the second clamping member 22, and then the first pressing portion 341 and the second pressing portion 342 are connected to the first transition connection portion 3433 and the second transition connection portion 3434 respectively. Then, the first pressing portion 341 and the second pressing portion 342 are pressed to drive the inner lining layer 1 to open and then be placed on the patient's ear. The first clamping member 21 and the second clamping member 22 are tightened by adjusting the second bolt 311b and the second nut 312b. Tighten the connection and apply pressure to the patient's ear. During the treatment, if the patient's diseased area changes as the repair progresses, the second bolt 311b can be adjusted to adjust the ear orthosis to adapt to the change in the shape of the auricle during the treatment. Specifically, during the orthosis, when the shape of the ear changes, the locking degree of the second bolt 311b can be manually adjusted to adjust the distance between the first clamp 21 and the second clamp 22, so that the first clamp 21 and the second clamp 22 can continue to apply a preset pressure to the surface of the auricle.

[0186] like Figure 5a-5c As shown, in some embodiments, the adjustment component 3 includes a mounting portion 35 and a magnetic member 36, the mounting portion 35 includes a first mounting portion 351 provided on the outer surface of the first clamping member 21, and a second mounting portion 352 provided on the outer surface of the second clamping member 22, the magnetic member 36 includes a first magnetic member 361 provided on the first mounting portion 351, and a second magnetic member 362 provided on the second mounting portion 352, and the first magnetic member 361 and the second magnetic member 362 are attracted to each other, the first mounting portion 351 and the second mounting portion 352 are correspondingly arranged, and the first magnetic member 361 and the second magnetic member 362 are correspondingly arranged.

[0187] In this way, the first clamping member 21 and the second clamping member 22 can be close to each other under the action of the adsorption force of the first magnetic member 361 and the second magnetic member 362, so that the first clamping member 21 and the second clamping member 22 can continuously apply a preset pressure to the surface of the auricle.

[0188] It should be noted that the first mounting portion 351 is disposed at the edge of the outer surface of the first clamping member 21, and the second mounting portion 352 is disposed at the edge of the outer surface of the second clamping member 22. Specifically, the first mounting portion 351 and the second mounting portion 352 are respectively located on both sides of the gap formed between the first clamping member 21 and the second clamping member 22.

[0189] In order to ensure a reliable connection between the first clamping member 21 and the second clamping member 22, a plurality of first mounting portions 351 are provided at intervals on the outer surface of the first clamping member 21, and a plurality of second mounting portions 352 are provided at intervals on the outer surface of the second clamping member 22. The plurality of second mounting portions 352 correspond one-to-one to the plurality of first mounting portions 351.

[0190] As an optional implementation, the first mounting portion 351 and the second mounting portion 352 are both triangular prism structures, and two edges of the triangular prism structure are located on the outer surface of the first clamping member 21 or the second clamping member 22 .

[0191] Specifically, two edges of the first mounting portion 351 and the second mounting portion 352 extend along the outer surface of the first clamping member 21 and the second clamping member 22, and the other edge protrudes from the outer surface of the first clamping member 21 or the second clamping member 22. Therefore, the cross-sectional area of ​​the first mounting portion 351 and the second mounting portion 352 on the side (top) away from the first clamping member 21 and the second clamping member 22 is smaller than the cross-sectional area on the side (bottom) close to the surface of the first clamping member 21 and the second clamping member 22.

[0192] In this embodiment, the thickness of the triangular prism ranges from 2 mm to 5 mm, and the length of its side ranges from 6 mm to 10 mm.

[0193] In order to allow the distance between the first clamping member 21 and the second clamping member 22 to change as the correction process progresses, that is, to adapt to the change of the ear shape during the correction process and change the distance between the first clamping member 21 and the second clamping member 22 so that the retainer 2 will not loosen due to the recovery of the diseased area, thereby ensuring a good correction effect, therefore, when the first clamping member 21 and the second clamping member 22 are not changed in the diseased area and are mounted on the inner lining layer 1, there should be a certain gap between the first magnetic member 361 and the second magnetic member 362.

[0194] Furthermore, in order to allow a gap to exist between the first magnetic member 361 and the second magnetic member 362, the corresponding first mounting portion 351 and the second mounting portion 352 may be arranged at an angle so that the tops of the first mounting portion 351 and the second mounting portion 352 diverge in opposite directions to ensure that there is a gap between the first magnetic member 361 and the second magnetic member 362 mounted thereon.

[0195] Optionally, the angle between the first mounting portion 351 and the second mounting portion 352 ranges from 5° to 45°.

[0196] In order to further increase the pressure applied to the ear by the retainer 2 on the basis of the adsorption force of the first magnetic part 361 and the second magnetic part 362, the adjustment component 3 also includes an elastic band. In this way, by setting the elastic band, the pressure applied by the retainer 2 on the patient's ear can be increased to facilitate the repair of the patient's ear.

[0197] As an optional implementation, the elastic band is wound around the first mounting portion 351 and the second mounting portion 352 .

[0198] As another optional implementation, the elastic band is wound around the first magnetic member 361 and the second magnetic member 362 .

[0199] In some embodiments, a first mounting hole is provided at the end of the first mounting portion 351 away from the first clamping member 21, and a portion of the first magnetic member 361 is embedded in the first mounting hole; a second mounting hole is provided at the end of the second mounting portion 352 away from the second clamping member 22, and a portion of the second magnetic member 362 is embedded in the second mounting hole.

[0200] Specifically, the first magnetic component 361 is connected to the first mounting portion 351 through the first mounting hole, and then assembled on the first clamping component 21. The second magnetic component 362 is connected to the second mounting portion 352 through the second mounting hole, and then assembled on the second clamping component 22, so that the first clamping component 21 and the second clamping component 22 are fixedly connected by the adsorption force between the first magnetic component 361 and the second magnetic component 362.

[0201] In other embodiments, the first magnetic component 361 has a first positioning hole, and the second magnetic component 362 has a second positioning hole. The first magnetic component 361 is sleeved on the top of the first mounting portion 351 through the first positioning hole; the second magnetic component 362 is sleeved on the top of the second mounting portion 352 through the second positioning hole.

[0202] Furthermore, the first magnetic member 361 and the second magnetic member 362 are both magnets.

[0203] In this embodiment, the magnet is a spherical magnet, and the diameter of the spherical magnet ranges from 6 mm to 10 mm.

[0204] It should be noted that the first mounting portion 351 and the second mounting portion 352 may also be other structures that are convenient for installing the first magnetic part 361 and the second magnetic part 362, such as a conical structure, etc.; the first magnetic part 361 and the second magnetic part 362 may also be other shapes that can facilitate the adsorption and matching of the first magnetic part 361 and the second magnetic part 362, and this embodiment does not impose any specific restrictions on this.

[0205] When using the ear orthosis provided in this embodiment, first, the lining layer 1 is put on the patient's ear, and then the first clamping member 21 and the second clamping member 22 are respectively put on the lining layer 1, and the first magnetic member 361 and the second magnetic member 362 are adsorbed to each other to fix the first clamping member 21 and the second clamping member 22. During the treatment process, since the first clamping member 21 and the second clamping member 22 are movably connected by the first magnetic member 361 and the second magnetic member 362, when the shape of the ear changes during the correction process, the distance between the first clamping member 21 and the second clamping member 22 can be close to each other under the adsorption action of the first magnetic member 361 and the second magnetic member 362, so that the first clamping member 21 and the second clamping member 22 can continue to apply a preset pressure to the surface of the auricle. If part of the diseased area of ​​the patient returns to normal, part of the first magnetic member 361 and the second magnetic member 362 can also be removed to reduce the pressure in the area that has returned to normal.

[0206] The ear orthosis provided in this embodiment includes: an inner lining layer and a retainer, wherein a first area of ​​the inner surface of the inner lining layer covers the diseased area of ​​the auricle, and an outer surface of the inner lining layer is detachably connected to the retainer; the retainer is used to make the first area fit the diseased area of ​​the auricle and apply a preset pressure to the diseased area of ​​the auricle; and the hardness of the retainer is greater than the hardness of the inner lining layer. The hardness of the inner lining layer in the ear orthosis provided in this embodiment is less than the hardness of the retainer, so that the comfort of the patient wearing the ear orthosis of the present invention can be improved.

[0207] Figure 6a A flowchart of the steps of a method for preparing an ear orthosis provided in an embodiment of the present invention. Figure 6b A flow chart of the steps of generating an inner lining layer model according to an auricle model in the method for preparing an ear orthosis provided in an embodiment of the present invention. Figure 6c A flowchart of another step of generating an inner lining layer model according to an auricle model in the method for preparing an ear orthosis provided by an embodiment of the present invention. Figure 6d A flow chart of the steps of segmenting a retainer model and obtaining an adjustment component model in a method for preparing an ear orthosis provided in an embodiment of the present invention. Figure 6e A flowchart of the steps of performing three-dimensional printing according to an inner lining layer model and a retainer in a method for preparing an ear orthosis provided in an embodiment of the present invention to obtain an ear orthosis including an inner lining layer and a retainer. Figure 6f A flow chart of the steps of obtaining an auricle model in the method for preparing an ear orthosis provided in an embodiment of the present invention.

[0208] like Figures 6a to 6f As shown, an embodiment of the present invention also provides a method for preparing an ear orthosis.

[0209] It should be noted that the structure of the ear orthosis has been specifically described in the above embodiments, and the ear orthosis will not be described in detail here.

[0210] like Figure 6a As shown, an embodiment of the present invention provides a method for preparing an ear orthosis, comprising the following steps:

[0211] S101: Acquire an auricle model, where the auricle model includes at least one lesion area.

[0212] In this way, the auricle model with the diseased area is obtained to facilitate printing of the lining layer.

[0213] S102: Generate an inner lining layer model according to the auricle model, wherein the shape of the inner surface of the inner lining layer model matches the outer surface of the auricle model, and the inner surface of the inner lining layer model covers the diseased area of ​​the auricle model.

[0214] In this way, the lining layer model is generated according to the auricle model, and the shape of the inner surface of the lining layer model matches the outer surface of the auricle model. The inner surface of the lining layer model covers the diseased area of ​​the auricle model so that the diseased area is effectively in contact with the lining layer, which is beneficial to the repair and later reshaping of the patient's ear.

[0215] S103: Generate a retainer model according to the lining layer model, the retainer model is wrapped around the outer side of the lining layer model, and at least a portion of the retainer model is in contact with the lining layer model to generate a preset pressure in the lesion area of ​​the auricle model.

[0216] In this way, the retainer model is generated according to the lining layer model, so that the retainer model can protect and support the lining layer model, and the retainer model applies pressure to the diseased area of ​​the auricle, so that the diseased area of ​​the ear can return to normal more quickly.

[0217] S104: Perform three-dimensional printing according to the lining layer model and the retainer model to obtain an ear orthosis including the lining layer and the retainer, wherein the hardness of the retainer is greater than the hardness of the lining layer.

[0218] In this way, the ear orthosis is formed by printing the lining layer model and the retainer model as a whole or separately, and the hardness of the retainer is greater than that of the lining layer, so that the diseased area is in contact with the lining layer with low hardness, thereby improving the comfort of the patient wearing the ear orthosis.

[0219] In this embodiment, the step of generating the lining layer model according to the auricle model includes:

[0220] S201: Along the normal direction of the outer surface of the auricle model, stretch the outer surface of the auricle model by a first distance in a direction away from the auricle model to obtain an initial lining layer model.

[0221] In this way, the initial lining layer model is obtained by stretching the first distance in the direction away from the auricle model, so as to form a space for accommodating the ear diseased area in the lining layer model, so that the lining layer can be put on the ear.

[0222] S202: On the inner surface of the lesion area of ​​the initial lining layer model corresponding to the auricle model, the inner surface of the lesion area of ​​the initial lining layer model corresponding to the auricle model is stretched a second distance in a direction close to the auricle model along the normal direction of the inner surface of the initial lining layer model to generate the lining layer model.

[0223] In this way, by stretching the second distance in the direction close to the auricle model, the inner lining layer model is generated, so that after the retainer is locked, the inner lining layer can achieve an interference fit with the diseased area, so as to apply force to the diseased area and facilitate the repair of the diseased area.

[0224] Optionally, the step of generating the lining layer model according to the auricle model includes:

[0225] S301: Repair the auricle model.

[0226] It should be noted that this step is applicable to repairing the auricle model that has not yet been restored.

[0227] S302: stretching the outer surface of the repaired auricle model by a first distance in a direction away from the auricle model to obtain an inner lining layer model.

[0228] In this way, the lining layer generated according to the repaired auricle model can produce an interference fit with the diseased area when actually worn, thereby generating pressure on the diseased area, which is beneficial to the repair of the diseased area.

[0229] In a specific implementation of this embodiment, the first distance is 1 mm-2 mm, and the second distance is 0.3 mm-0.8 mm.

[0230] In a specific implementation of this embodiment, the step of generating a retainer model based on the lining layer model includes: stretching the outer surface of the lining layer model corresponding to the diseased area of ​​the auricle model along the normal direction of the outer surface of the lining layer model by a third distance in a direction away from the lining layer model to obtain the retainer model.

[0231] In this way, it can be ensured that the retainer model has a suitable thickness, which is convenient for the patient to wear the ear orthosis and can improve the comfort of the patient wearing the ear orthosis.

[0232] Optionally, in the step of generating a retainer model according to the lining layer model, after obtaining the retainer model, the step further includes:

[0233] S401: Segment the retainer model to obtain a first clamping piece model and a second clamping piece model.

[0234] In this way, the retainer model is divided to form a dividing groove, which divides the retainer model into a first clamping member model and a second clamping member model. Specifically, in order to facilitate the installation of the first clamping member model and the second clamping member model, the dividing groove can be set at a position opposite to the helix of the auricle, that is, the first clamping member model can be located at the front side of the auricle, and the second clamping member model can be located at the back side of the auricle.

[0235] S402: Obtain an adjustment component model connected between the first clamp model and the second clamp model, and combine the adjustment component model with the first clamp model and the adjustment component model with the second clamp model.

[0236] Specifically, the adjustment component can be combined with the retainer model or the first clamping member model and the second clamping member model through Boolean operations or the like; wherein the first clamping member model and the second clamping member model are movably connected or detachably fixedly connected through the adjustment component.

[0237] In this embodiment, the steps of performing three-dimensional printing according to the lining layer model and the retainer model to obtain the ear orthosis including the lining layer and the retainer include:

[0238] S501: Slice the lining layer model to obtain lining layer printing control data, and slice the retainer model to obtain retainer printing control data; or, slice the lining layer model and the retainer model at the same time to obtain the printing control data of the lining layer and the retainer.

[0239] In this way, a plurality of slice layers can be obtained by slicing the retainer model, and then each slice layer can be laminated and printed to obtain the lining layer and / or the retainer.

[0240] S502: The 3D printer prints out the lining layer according to the lining layer printing control data, and prints out the retainer according to the retainer printing control data; or, prints out the lining layer and the retainer according to the lining layer and the retainer printing control data.

[0241] In this way, a holder composed of the first clamping member and the second clamping member can be obtained.

[0242] In a specific implementation of this embodiment, the step of obtaining the auricle model includes:

[0243] S601: Acquire scanning data of the auricle.

[0244] By acquiring the scanning data of the auricle, the parameters of the auricle, such as the thickness of the auricle, etc., can be obtained to obtain an accurate auricle model.

[0245] S602: Establish a three-dimensional digital model of the auricle according to the scan data.

[0246] By establishing a three-dimensional digital model of the auricle, a lining layer that fits the auricle can be printed out using a three-dimensional printer to repair the ear.

[0247] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An ear orthosis, characterized in that: include: An inner lining layer and a retainer, wherein a first area of ​​an inner surface of the inner lining layer covers a diseased area of ​​the auricle; The retainer is used to make the first area fit the diseased area of ​​the auricle and apply a preset pressure to the diseased area of ​​the auricle; and the hardness of the retainer is greater than the hardness of the lining layer; The retainer includes a first clamping member and a second clamping member, and an adjustment assembly for connecting the first clamping member and the second clamping member; The adjustment assembly includes a first connecting member, which includes a pair of ball heads and a retaining cavity. The retaining cavity is arranged corresponding to the ball head and the ball head is hinged to the retaining cavity. The ball head is arranged on one of the ends of the first clamping member and the second clamping member, and the retaining cavity is arranged on the other of the ends of the first clamping member and the second clamping member.

2. The ear orthosis according to claim 1, characterized in that The shape of the inner surface of the lining layer matches the shape of the auricle, and the first area is an area of ​​the inner surface of the lining layer that is directly opposite to the diseased area of ​​the auricle.

3. The ear orthosis according to claim 2, characterized in that: The edge of the lining layer is extended by at least 0.5 mm relative to the edge of the lesion area of ​​the auricle.

4. The ear orthosis according to claim 2 or 3, characterized in that: The first area is coated with medicine, or medicine is added to the material of the lining layer located in the first area.

5. The ear orthosis according to claim 1, characterized in that: The shape of the inner surface of the retainer matches the shape of the outer surface of the inner lining layer, and a region of the inner surface of the retainer that faces the diseased region of the auricle contacts the inner lining layer.

6. The ear orthosis according to claim 1, characterized in that: The lining layer is detachably connected to the retainer.

7. The ear orthosis according to claim 1, characterized in that: The first connecting member is connected to the first clamping member and the second clamping member respectively.

8. The ear orthosis according to claim 7, characterized in that The adjustment assembly also includes a first reinforcing rib and a second reinforcing rib, wherein the first reinforcing rib is disposed on an outer surface of the first clamping member, the second reinforcing rib is disposed on an outer surface of the second clamping member, and the first connecting member is connected to the first reinforcing rib and the second reinforcing rib respectively.

9. The ear orthosis according to any one of claims 1-3, 5-6, characterized in that: The first connecting member includes a first fastening member, and the first fastening member is used for detachably connecting the first clamping member and the second clamping member.

10. The ear orthosis according to claim 9, characterized in that The first fastener is one or more of a buckle, a bolt, and a ball.

11. A method for preparing the ear orthosis according to any one of claims 1 to 10, characterized in that: The steps include: Acquiring an auricle model, wherein the auricle model includes at least one lesion area; Generate an inner lining layer model according to the auricle model, wherein the shape of the inner surface of the inner lining layer model matches the outer surface of the auricle model, and the inner surface of the inner lining layer model covers the lesion area of ​​the auricle model; Generating a retainer model according to the inner lining layer model, wherein the retainer model is wrapped around the outer surface of the inner lining layer model, and at least a portion of the retainer model is in contact with the inner lining layer model to generate a preset pressure in the lesion area of ​​the auricle model; Three-dimensional printing is performed according to the lining layer model and the retainer model to obtain the ear orthosis including the lining layer and the retainer, wherein the hardness of the retainer is greater than the hardness of the lining layer.

12. The method for preparing an ear orthosis according to claim 11, characterized in that: The step of generating the lining layer model according to the auricle model comprises: Along the normal direction of the outer surface of the auricle model, stretching the outer surface of the auricle model by a first distance in a direction away from the auricle model to obtain an initial lining layer model; On the inner surface of the diseased area of ​​the initial lining layer model corresponding to the auricle model, the inner surface of the diseased area of ​​the initial lining layer model corresponding to the auricle model is stretched a second distance in a direction close to the auricle model along the normal direction of the inner surface of the initial lining layer model to generate an lining layer model.

13. The method for preparing an ear orthosis according to claim 12, characterized in that: The step of generating the lining layer model according to the auricle model comprises: Repairing the auricle model; The outer surface of the repaired auricle model is stretched a first distance in a direction away from the auricle model to obtain an inner lining layer model.

14. The method for preparing an ear orthosis according to claim 12 or 13, characterized in that: The first distance ranges from 1 mm to 2 mm, and the second distance ranges from 0.3 mm to 0.8 mm.

15. The method for preparing an ear orthosis according to claim 11, characterized in that: The step of generating a retainer model according to the lining layer model comprises: The outer surface of the lining layer model corresponding to the lesion area of ​​the auricle model is stretched a third distance in a direction away from the lining layer model along the normal direction of the outer surface of the lining layer model to obtain the retainer model.

16. The method for preparing an ear orthosis according to claim 11, characterized in that: After generating the retainer model according to the lining layer model, the method further includes: Segmenting the retainer model to obtain a first clamping piece model and a second clamping piece model; An adjusting component model connected between the first clamping component model and the second clamping component model is obtained, and the adjusting component model and the first clamping component model are combined, and the adjusting component model and the second clamping component model are combined.

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