An auricle orthosis, a preparation method thereof and a using method thereof

Abstract

The present invention relates to an auricle orthosis and its preparation method and usage method. An auricle orthosis includes a front splint, a rear splint, and a flexible cushion. The front and rear splints are in a C-like shape; the flexible cushion has the same shape as the front and rear splints and is placed on the side where the front and rear splints contact the ear skin when the auricle orthosis is in use. The hardness of the front and rear splints of the auricle orthosis can change with time and temperature, and it has excellent plasticity, tear resistance, waterproofness, and dimensional stability. At the same time, it has an aromatic smell, can better improve the user experience, and can be recycled. After being discarded, it can be degraded and is friendly to the environment.

Description

Technical Field

[0001] The present invention relates to the field of medical rehabilitation care devices, and more particularly to an auricular orthosis and its preparation method and usage method. Background Art

[0002] Auricular morphological deformities are common in newborns, mostly caused by congenital reasons such as genetics, having metabolic diseases during pregnancy, or exposure to certain chemicals and radioactive substances. Common auricular morphological deformities include protruding ears, cryptotia, cup ears, lop ears, etc. Auricular morphological deformities are not only an aesthetic defect, but also have an adverse impact on the physical and psychological development of children. The earlier the treatment, the better. If the treatment is carried out within 7 days after the child is born, the orthosis can be completed within half a month.

[0003] The traditional treatment method for congenital auricular deformities is surgery, which has the disadvantages of large trauma, poor appearance, high difficulty, etc. In the 1980s, Japanese scholars Matsuo and Kurozumi proposed a non-surgical treatment plan, using various splint-like materials to continuously compress or pull the outer ear to achieve the purpose of orthosis. This method is non-invasive, simple to operate, has good curative effect and no rebound, and has become a commonly used clinical treatment method for auricular deformity orthosis.

[0004] Currently, most auricular orthoses on the market are made of photosensitive resin materials using 3D printing technology, such as CN209884505U. Such auricular orthoses have the following disadvantages: 1) The high raw material cost leads to expensive product prices; 2) The preparation method is complex; 3) They have the common smell of plastics, and since the ears are close to the nasal cavity, long-term wearing will cause discomfort to children; 4) They are non-degradable after being discarded and are not environmentally friendly.

[0005] Therefore, an auricular orthosis with advantages such as no peculiar smell, low cost, environmental friendliness, and strong plasticity is highly needed. Summary of the Invention

[0006] In view of the problems of existing auricular orthoses in the above-mentioned prior art, one of the purposes of the present invention is to provide an auricular orthosis, which has excellent plasticity, waterproofness and dimensional stability, and at the same time has an aromatic smell to improve the user experience; and during the treatment process, the shape can be changed according to the orthosis requirements, recycled, the use cost is reduced, and the waste is degradable and environmentally friendly.

[0007] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0008] An auricular orthosis includes a front splint, a rear splint and a flexible buffer pad.

[0009] In the above technical solution, the front and rear splints are in a shape similar to the letter "C"; the flexible cushion has the same shape as the front and rear splints and is placed on the side where the front and rear splints contact the ear skin when the auricle orthosis is in use. There is no fixed connection between the flexible cushion and the front and rear splints, and they can be attached together during use. In addition, there is no fixed connection between the front and rear splints. During use, an adhesive material, such as medical tape, is used to bind and adhere the front and rear splints to the front and rear of the auricle. Among them, the shape of the flexible cushion material can be unrestricted, and preferably it is a rectangular, square, circular sheet, etc. of the same size as the ear, and it is cut according to the shape of the front and rear splints during use.

[0010] In the above technical solution, the front splint and the rear splint have and / or do not have a hole structure, and preferably have a hole structure; the flexible cushion has and / or does not have a hole structure, and preferably has a hole structure.

[0011] In the above technical solution, the hole structure is distributed through the front splint, the rear splint and / or the flexible cushion, and the interval between the holes is 1-10 mm, preferably 2-4 mm; the aperture of the hole structure is 1-10 mm, preferably 1-3 mm.

[0012] When both the front splint and the flexible cushion, or the rear splint and the flexible cushion have a hole structure, it is preferred that the hole structures of the two correspond and penetrate through, so as to make the auricle orthosis have good air permeability.

[0013] In the above technical solution, the thickness of the front splint and the rear splint is 0.2-5 mm, preferably 0.5-3 mm.

[0014] In the above technical solution, the width of the front splint and the rear splint is 5-30 mm.

[0015] In the above technical solution, the thickness of the flexible cushion is 0.1-2 mm, preferably 0.5-1.5 mm.

[0016] In the above technical solution, the material of the flexible cushion is selected from at least one of rubber, sponge, thermoplastic elastomer, cloth, paper, gel, leather and plasticine. The flexible cushion material can be a material with holes, or holes can be punched in the front and rear splints together with the front and rear splints during preparation.

[0017] In the above technical solution, the front splint and the rear splint are made of a copolyester material, and the copolyester material contains copolyester X and copolyester Y; wherein the copolyester X contains aliphatic diacid and / or its derivative segments, aromatic diacid and / or its derivative segments and glycol segments; the glycol segments include at least one glycol segment with a cyclic structure segment and at least one aliphatic glycol segment; wherein the molar percentage of the aromatic diacid and / or its derivative segments in the total diacid and / or its derivative segments is 15-60%.

[0018] Wherein the copolyester Y contains aliphatic diacid and / or its derivative segments, aromatic diacid and / or its derivative segments and at least one aliphatic glycol segment; wherein the molar percentage of the aromatic diacid and / or its derivative segments in the total diacid and / or its derivative segments is 50-95%. In the present invention, when the content of the aromatic diacid in the copolyesters X and Y in the total diacid is within the above range, the rigidity of the copolyester can be improved to varying degrees.

[0019] In the above technical solution, based on 100 parts by weight of the total copolyester, the copolyester X is 50-99 parts, preferably 55-80 parts; when the content of the copolyester X in the present invention is within the above range, the temperature required for the material to trigger softening can be reduced to varying degrees, and the hardness and wear resistance of the material can be increased;

[0020] The copolyester Y is 1-50 parts, preferably 20-45 parts. When the content of the copolyester Y in the present invention is within the above range, the curing time required for the copolyester composition material can be reduced to varying degrees.

[0021] In the above technical solution, the molar percentage of the aromatic diacid and / or its derivative segments in the copolyester X in the total diacid and / or its derivative segments is 25-60%, more preferably 30-60%.

[0022] Preferably, the molar percentage of the glycol segment with a cyclic structure in the copolyester X in the total glycol segments is 1-60%, preferably 5-25%. The introduction of the glycol with a cyclic structure can increase the rigidity of the copolyester, reduce the temperature required for the material to trigger softening, and increase the hardness and wear resistance of the material.

[0023] Preferably, the molar ratio of the total diacid segments to the total glycol segments in the copolyester X is (0.8-1):1, preferably (0.9-1):1.

[0024] Preferably, the molar percentage of the aromatic diacid and / or its derivative segments in the copolyester Y in the total diacid and / or its derivative segments is 60-85%.

[0025] Preferably, the molar ratio of the total diacid segments to the total glycol segments in the copolyester Y is (0.8-1):1, preferably (0.9-1):1.

[0026] In the above technical solution, the copolyester X and the copolyester Y are each independently at least one of a random copolymer, an alternating copolymer, a block copolymer, and a graft copolymer, preferably a random copolymer and / or a block copolymer.

[0027] In the above technical solution, the molecular weight range of the copolyester X and the copolyester Y is 20,000 - 200,000, preferably 80,000 - 150,000.

[0028] In the above technical solution, the aliphatic diacid and / or its derivative is selected from at least one of succinic acid and / or its derivative, adipic acid and / or its derivative.

[0029] The aromatic diacid and / or its derivative is selected from terephthalic acid and / or its derivative.

[0030] The diol with a cyclic structure is selected from at least one of 1,4 - cyclohexanedimethanol, isosorbide, and 2,2,4,4 - tetramethyl - 1,3 - cyclobutanediol.

[0031] The aliphatic diol is selected from at least one of 1,3 - propanediol / 1,4 - butanediol or 1,6 - hexanediol.

[0032] Among them, the introduction of the diol with a cyclic structure in the copolyester X alone can reduce the lamellar thickness of the copolyester, thereby reducing the melting point of the copolyester and increasing the convenience during its use. On the other hand, the introduction of the diol with a cyclic structure can reduce the crystallization rate of the copolyester, resulting in an increase in the curing time of the copolyester material.

[0033] The copolyester Y alone has a shorter curing time than the copolyester X alone, but has a higher softening temperature, poorer hardness and wear resistance. Therefore, the composition of the copolyester X and the copolyester Y makes up for the deficiencies of the copolyester X or Y alone, and by adjusting the ratio of the two, a copolyester composition with appropriate softening temperature, hardness, wear resistance, and curing time can be obtained.

[0034] In the above technical solution, the aliphatic diol segment in the copolyester X is different from the aliphatic diol segment in the copolyester Y; preferably,

[0035] The aliphatic diol segment in the copolyester X comes from 1,4 - butanediol; the aliphatic diol segment in the copolyester Y comes from 1,3 - propanediol and / or 1,6 - hexanediol.

[0036] In the above technical solution, based on the total weight of the copolyester X and the copolyester Y being 100 parts, it further contains 0.5 - 10 parts, preferably 1.5 - 8 parts of essence.

[0037] The fragrance is selected from at least one of fruit fragrances and floral fragrances; the fruit fragrances include, but are not limited to, flavors such as strawberry, banana, sweet orange, pineapple, grape, etc.; the floral fragrances include, but are not limited to, flavors such as rose, jasmine, tuberose, lily of the valley, magnolia, etc.

[0038] In the above technical solution, based on the total weight of copolyester X and copolyester Y being 100 parts, it further contains 1 - 15 parts of a lubricant, and the lubricant is selected from at least one of stearic acid, butyl stearate, oleamide, ethylene bisstearamide, and low-density polyethylene.

[0039] The preparation method of the copolyester material of the present invention includes the step of melt-blending the components including the copolyester X and copolyester Y after mixing.

[0040] In the above technical solution, the mixing is carried out under stirring conditions, and the stirring rate is 20 - 150 r / min.

[0041] In the above technical solution, the stirring time is 5 - 15 min.

[0042] In the above technical solution, the melt-blending is carried out by extrusion granulation through a twin-screw extruder; preferably, the temperature of the extrusion granulation is 110 - 260 °C, more preferably 160 - 220 °C.

[0043] The second object of the present invention is to provide a preparation method of the auricle orthosis, which has low production cost, is convenient to use, and has a good user experience.

[0044] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0045] A preparation method of an auricle orthosis includes successively extruding, molding, and / or cutting a copolyester material to obtain the front splint and rear splint profiles of the auricle orthosis, and the extrusion is preferably melt extrusion.

[0046] In the above technical solution, the temperature of the extrusion is 90 - 230 °C, preferably 110 - 170 °C;

[0047] The molding method is injection molding and / or compression molding. The equipment also uses the extrusion, injection molding, and compression molding equipment commonly used in the prior art.

[0048] The third object of the present invention is to provide a usage method of the auricle orthosis, which includes heating the front and rear splint profiles of the auricle orthosis to make them fully softened, then quickly cooling them to a temperature acceptable to the human body, and shaping them according to the ear morphological characteristics of the child and the orthosis plan; after shaping, waiting for it to harden.

[0049] Preferably, heat the front splint profile of the above auricle orthosis to make it fully softened. The heating methods include but are not limited to soaking in hot water, especially boiling water, heating in a microwave oven, oven, hot plate, etc.; then quickly cool it to a temperature acceptable to the human body. The cooling methods include but are not limited to soaking in cold water, ice water or liquid nitrogen, contacting with ice cubes or ice packs, placing in the refrigerator's cold storage or freezer or ice chest; then wipe it clean, and shape it according to the ear morphological characteristics of the child and the orthosis plan; after shaping, wait for it to harden to obtain the front splint. The rear splint can be obtained in the same way. When in use, the front and rear splints are bound and adhered to the front and rear of the auricle with medical adhesive tape.

[0050] Advantages of the present invention:

[0051] 1. Lower cost;

[0052] 2. Simple manufacturing method;

[0053] 3. With a fragrant smell and good user experience;

[0054] 4. Can be recycled, degradable after being discarded, and environmentally friendly. Description of the drawings

[0055] Figure 1 It is a schematic structural diagram of the auricle orthosis of the present invention.

[0056] Reference numerals: 1. Front / rear splint, 2. Flexible cushion material, 3. Ventilation holes. The front and rear splints are in a C-like shape; the flexible cushion has the same shape as the front and rear splints. Detailed implementation manners

[0057] The present invention will be specifically described below in conjunction with specific embodiments. It is necessary to point out here that the following embodiments are only used for further illustration of the present invention and cannot be understood as limiting the protection scope of the present invention. Some non-essential improvements and adjustments made by those skilled in the art according to the content of the present invention still fall within the protection scope of the present invention.

[0058] In addition, it should be noted that among the various specific technical features described in the following detailed implementation manners, they can be combined in any appropriate manner without contradiction. To avoid unnecessary repetition, the present invention will not separately describe various possible combination methods.

[0059] Furthermore, any combination can be made between various different implementation manners of the present invention as long as it does not violate the idea of the present invention. The technical solutions formed thereby belong to a part of the original public content of this specification and also fall within the protection scope of the present invention.

[0060] Source of reagents: All reagents used in the present invention are commercially available.

[0061] In the following examples and comparative examples, the weight-average molecular weight of the polymer was measured by gel permeation chromatography (GPC) using tetrahydrofuran (THF) as the solvent on a Waters-208 instrument (equipped with a Waters 2410 RI detector, a flow rate of 1.5 mL / min, and a temperature of 30 °C), and calibrated with styrene standard samples.

[0062] The composition of the polyester composition was determined by the feeding of raw materials; among them, the types of reaction raw materials could be adjusted accordingly according to the composition and molecular weight of the target product, and the molecular weight of the product and the content of each repeating unit in the product were controlled by adjusting the feeding amount and feeding ratio, respectively.

[0063] Example 1

[0064] An auricle orthosis, comprising a front splint, a rear splint, and a flexible cushion. The front and rear splints are in a C-like shape, and the flexible cushion has the same shape as the front and rear splints. The front splint, rear splint, and flexible cushion have a pore structure with a 2.5-mm interval between the pores; the pore diameter of the pore structure is 2 mm. The material of the flexible cushion is selected from sponge, and the thickness of the flexible cushion is 0.5 mm.

[0065] Preparation and use of the auricle orthosis: Under stirring conditions (stirring rate: 30 rpm, time: 10 min), 7 kg of terephthalic acid-butylene glycol-succinic acid-1,4-cyclohexanedimethanol copolyester X (weight-average molecular weight: 120,000, wherein, based on the total molar number of terephthalic acid and succinic acid repeating units, the content of terephthalic acid repeating units is 60 mol%; based on the total molar number of butylene glycol and 1,4-cyclohexanedimethanol repeating units, the content of 1,4-cyclohexanedimethanol repeating units is 25 mol%) particles, 2.5 kg of terephthalic acid-propylene glycol-succinic acid copolyester Y (weight-average molecular weight: 100,000, wherein, based on the total molar number of terephthalic acid and succinic acid repeating units, the content of terephthalic acid repeating units is 60 mol%), 0.2 kg of jasmine essence and 0.3 kg of low-density polyethylene are mixed. Among them, the molar ratio of the total diacid segment to the total diol segment in the copolyester X is 0.95:1, and the molar ratio of the total diacid segment to the total diol segment in the copolyester Y is 0.95:1. The obtained mixture is extruded and pelletized by a twin-screw extruder, the rotation speed of the screw is controlled at 10 rpm, the torque is 20 N*m, and the temperatures of each section from the feed port to the discharge port in the twin-screw extruder are 150 °C, 160 °C, 170 °C, 170 °C, 170 °C, 170 °C in sequence, to obtain the copolyester material A1. The copolyester material A1 is melted and pressed into a C-shaped structure with appropriate size at 170 °C and 1000 MPa, and waits for about 1 hour to completely harden, then the front / rear splint B1 of the auricle orthosis can be obtained. When in use, the front splint and the rear splint are placed in boiling water (100 °C) for about 40 s to fully soften them, then taken out and placed in ice water to quickly cool them to about 37 °C, wiped dry, and shaped according to the auricular morphological characteristics of the child and the orthosis plan. After shaping, wait for it to harden, attach the flexible buffer pad to the side of the front and rear splints in contact with the ear, and then use medical tape to bind and adhere the front and rear splints to fix them in front of and behind the auricle.

[0066] Example 2

[0067] An auricle orthosis, comprising a front splint, a rear splint and a flexible buffer pad. The front and rear splints are in a C-shaped structure, and the shape of the flexible buffer pad is the same as that of the front and rear splints. The front splint, the rear splint and the flexible buffer pad have a hole structure, the interval between the holes is 2 mm; the aperture of the hole structure is 2 mm. The material of the flexible buffer pad is selected from sponge, and the thickness of the flexible buffer pad is 0.8 mm.

[0068] Preparation and use of the auricle orthosis: Under stirring conditions (stirring rate: 30 rpm, time: 10 min), 6.5 kg of terephthalic acid-butylene glycol-adipic acid-isosorbide copolyester X (weight-average molecular weight: 130,000, wherein, based on the total molar number of terephthalic acid and adipic acid repeating units, the content of terephthalic acid repeating units is 55 mol%; based on the total molar number of butylene glycol and isosorbide repeating units, the content of isosorbide repeating units is 20 mol%) particles, 3 kg of terephthalic acid-hexylene glycol-succinic acid copolyester Y (weight-average molecular weight: 100,000, wherein, based on the total molar number of terephthalic acid and succinic acid repeating units, the content of terephthalic acid repeating units is 60 mol%), 0.2 kg of jasmine essence and 0.3 kg of low-density polyethylene are mixed. Among them, the molar ratio of the total diacid segment to the total diol segment in the copolyester X is 1:1, and the molar ratio of the total diacid segment to the total diol segment in the copolyester Y is 1:1. The obtained mixture is extruded and granulated by a twin-screw extruder, the rotation speed of the screw is controlled at 10 rpm, the torque is 20 N*m, and the temperatures of each section from the feed port to the extrusion port in the twin-screw extruder are 150°C, 160°C, 170°C, 170°C, 170°C, 170°C in sequence to obtain the copolyester material A2. The copolyester material A2 is melted and pressed into a suitable C-shaped structure at 170°C and 1000 MPa, and waits for about 1 hour to completely harden to obtain the front / rear splint B2 of the auricle orthosis. During use, the front splint and the rear splint are placed in boiling water (100°C) for about 40 s to be fully softened, then taken out and placed in ice water to be quickly cooled to about 37°C, dried, and shaped according to the auricular morphological characteristics of the child and the orthosis plan. After shaping, wait for it to harden, attach the flexible buffer pad to the side of the front and rear splints in contact with the ear, and then use medical tape to bind and adhere the front and rear splints to fix them in front of and behind the auricle.

[0069] Example 3

[0070] An auricle orthosis, comprising a front splint, a rear splint and a flexible buffer pad. The front and rear splints are in a C-shaped class form, and the shape of the flexible buffer pad is the same as that of the front and rear splints. The front splint, the rear splint and the flexible buffer pad have a hole structure, the interval between the holes is 2.5 mm; the aperture of the hole structure is 2 mm. The material of the flexible buffer pad is selected from rubber, and the thickness of the flexible buffer pad is 0.6 mm.

[0071] Preparation and use of the auricle orthosis: Under stirring conditions (stirring rate: 30 rpm, time: 10 min), 6.5 kg of terephthalic acid-butylene glycol-succinic acid-2,2,4,4-tetramethyl-1,3-cyclobutanediol copolyester X (weight-average molecular weight: 150,000, wherein, based on the total molar number of terephthalic acid and succinic acid repeating units, the content of terephthalic acid repeating units is 30 mol%; based on the total molar number of butylene glycol and 2,2,4,4-tetramethyl-1,3-cyclobutanediol repeating units, the content of 2,2,4,4-tetramethyl-1,3-cyclobutanediol repeating units is 20 mol%) particles, 3 kg of terephthalic acid-hexylene glycol-succinic acid copolyester Y (weight-average molecular weight: 100,000, wherein, based on the total molar number of terephthalic acid and succinic acid repeating units, the content of terephthalic acid repeating units is 60 mol%), 0.2 kg of jasmine essence and 0.3 kg of low-density polyethylene are mixed. Among them, the molar ratio of the total diacid segment to the total diol segment in the copolyester X is 0.9:1, and the molar ratio of the total diacid segment to the total diol segment in the copolyester Y is 0.9:1. The obtained mixture is extruded and pelletized by a twin-screw extruder. The rotation speed of the screw is controlled at 10 rpm, and the torque is 20 N*m. The temperatures of each section of the twin-screw extruder from the feed port to the discharge port are 150°C, 160°C, 170°C, 170°C, 170°C, 170°C in sequence to obtain the copolyester material A3. The copolyester material A3 is melted and pressed into a C-shaped structure with appropriate dimensions at 170°C and 1000 MPa, and waits for about 1 hour to fully harden to obtain the front / rear splint B3 of the auricle orthosis. During use, the front splint and the rear splint are placed in boiling water (100°C) for about 40 s to be fully softened, then taken out and placed in ice water to be quickly cooled to about 37°C. After drying, they are shaped according to the auricle morphological characteristics of the child and the orthosis plan. After shaping and waiting for them to harden, the flexible buffer pad is attached to the side of the front and rear splints in contact with the ear, and then the front and rear splints are bound and adhered and fixed to the front and rear of the auricle with medical adhesive tape.

[0072] Example 4

[0073] An auricle orthosis, comprising a front splint, a rear splint and a flexible buffer pad. The front and rear splints are in a C-shaped structure, and the shape of the flexible buffer pad is the same as that of the front and rear splints. The front splint, the rear splint and the flexible buffer pad have a hole structure, and the interval between the holes is 2 mm; the aperture of the hole structure is 2.5 mm. The material of the flexible buffer pad is selected from rubber, and the thickness of the flexible buffer pad is 0.6 mm.

[0074] Preparation and use of the auricle orthosis: Under stirring conditions (stirring rate: 30 rpm, time: 10 min), 7 kg of terephthalic acid-butylene glycol-succinic acid-1,4-cyclohexanedimethanol copolyester X (weight-average molecular weight: 120,000, where the content of terephthalic acid repeating units is 60 mol% based on the total molar number of terephthalic acid and succinic acid repeating units; the content of 1,4-cyclohexanedimethanol repeating units is 25 mol% based on the total molar number of butylene glycol and 1,4-cyclohexanedimethanol repeating units) particles, 2.5 kg of terephthalic acid-propylene glycol-succinic acid copolyester Y (weight-average molecular weight: 110,000, where the content of terephthalic acid repeating units is 80 mol% based on the total molar number of terephthalic acid and succinic acid repeating units), 0.2 kg of jasmine essence, and 0.3 kg of low-density polyethylene are mixed. Among them, the molar ratio of the total diacid segment to the total diol segment in the copolyester X is 0.95:1, and the molar ratio of the total diacid segment to the total diol segment in the copolyester Y is 1:1. The obtained mixture is extruded and pelletized through a twin-screw extruder. The rotational speed of the screw is controlled at 10 rpm, and the torque is 20 N*m. The temperatures of each section of the twin-screw extruder from the feed port to the discharge port are 150 °C, 160 °C, 170 °C, 170 °C, 170 °C, and 170 °C in sequence to obtain the copolyester material A4. The copolyester material A4 is melted and pressed into a C-shaped structure with appropriate dimensions at 170 °C and 1000 MPa, and waits for about 1 hour to completely harden to obtain the front / rear splint B4 of the auricle orthosis. During use, the front splint and the rear splint are placed in boiling water (100 °C) for about 40 s to fully soften them, then taken out and placed in ice water to quickly cool them to about 37 °C. After drying, they are shaped according to the auricular morphological characteristics of the child and the orthosis plan. After shaping and waiting for them to harden, the flexible cushion is attached to the side of the front and rear splints in contact with the ear, and then the front and rear splints are tied and adhered with medical tape to be fixed in front of and behind the auricle.

[0075] Example 5

[0076] An auricle orthosis, comprising a front splint, a rear splint, and a flexible cushion. The front and rear splints are in a C-shaped structure, and the shape of the flexible cushion is the same as that of the front and rear splints. The front splint, the rear splint, and the flexible cushion have a hole structure, and the interval between the holes is 2 mm; the aperture of the hole structure is 2 mm. The material of the flexible cushion is selected from sponge, and the thickness of the flexible cushion is 0.8 mm.

[0077] Preparation and use of the auricle orthosis: Under stirring conditions (stirring rate: 30 rpm, time: 10 min), 7 kg of terephthalic acid-butylene glycol-succinic acid-2,2,4,4-tetramethyl-1,3-cyclobutanediol copolyester X (weight-average molecular weight: 150,000, wherein, based on the total molar number of terephthalic acid and succinic acid repeating units, the content of terephthalic acid repeating units is 60 mol%; based on the total molar number of butylene glycol and 2,2,4,4-tetramethyl-1,3-cyclobutanediol repeating units, the content of 2,2,4,4-tetramethyl-1,3-cyclobutanediol repeating units is 10 mol%) particles, 2.5 kg of terephthalic acid-propylene glycol-succinic acid copolyester Y (weight-average molecular weight: 100,000, wherein, based on the total molar number of terephthalic acid and succinic acid repeating units, the content of terephthalic acid repeating units is 60 mol%), 0.2 kg of jasmine essence, and 0.3 kg of low-density polyethylene are mixed. Among them, the molar ratio of the total diacid segment to the total diol segment in the copolyester X is 1:1, and the molar ratio of the total diacid segment to the total diol segment in the copolyester Y is 0.9:1. The obtained mixture is extruded and pelletized by a twin-screw extruder. The rotation speed of the screw is controlled at 10 rpm, and the torque is 20 N*m. The temperatures of each section from the feed port to the extrusion port in the twin-screw extruder are 150 °C, 160 °C, 170 °C, 170 °C, 170 °C, and 170 °C in sequence to obtain the copolyester material A5. The copolyester material A5 is melted and pressed into a suitable-sized C-shaped structure at 170 °C and 1000 MPa, and waits for about 1 hour to completely harden, then the front / rear splint B5 of the auricle orthosis can be obtained. When in use, the front splint and the rear splint are placed in boiling water (100 °C) for about 40 s to be fully softened, then taken out and placed in ice water, quickly cooled to about 37 °C, dried, and shaped according to the auricular morphological characteristics of the child and the orthosis plan. After shaping, wait for it to harden. The flexible cushion is attached to the side of the front and rear splints in contact with the ear, and then the front and rear splints are bound and adhered and fixed to the front and rear of the auricle with medical adhesive tape.

[0078] Example 6

[0079] An auricle orthosis, comprising a front splint, a rear splint, and a flexible cushion. The front and rear splints are in a C-shaped form, and the flexible cushion has the same shape as the front and rear splints. The front splint, the rear splint, and the flexible cushion have a pore structure, and the interval between the pores is 2.5 mm; the pore diameter of the pore structure is 3 mm. The material of the flexible cushion is selected from gel, and the thickness of the flexible cushion is 0.6 mm.

[0080] Preparation and use of the auricle orthosis: Under stirring conditions (stirring rate: 30 rpm, time: 10 min), 7 kg of terephthalic acid-butylene glycol-succinic acid-isosorbide copolyester X (weight-average molecular weight: 130,000, wherein, based on the total molar number of terephthalic acid and succinic acid repeating units, the content of terephthalic acid repeating units is 60 mol%; based on the total molar number of butylene glycol and isosorbide repeating units, the content of isosorbide repeating units is 5 mol%) particles, 2.5 kg of terephthalic acid-propylene glycol-succinic acid copolyester Y (weight-average molecular weight: 100,000, wherein, based on the total molar number of terephthalic acid and succinic acid repeating units, the content of terephthalic acid repeating units is 60 mol%), 0.2 kg of jasmine essence, and 0.3 kg of low-density polyethylene are mixed. Among them, the molar ratio of the total diacid segment to the total diol segment in the copolyester X is 0.95:1, and the molar ratio of the total diacid segment to the total diol segment in the copolyester Y is 0.9:1. The obtained mixture is extruded and pelletized by a twin-screw extruder, the rotation speed of the screw is controlled at 10 rpm, the torque is 20 N*m, and the temperatures of each section from the feed port to the extrusion port in the twin-screw extruder are 150°C, 160°C, 170°C, 170°C, 170°C, 170°C in sequence to obtain the copolyester material A6. The copolyester material A6 is melted and pressed into a C-shaped structure with appropriate dimensions at 170°C and 1000 MPa, and waits for about 1 hour to completely harden to obtain the front / rear splint B6 of the auricle orthosis. When in use, the front splint and the rear splint are placed in boiling water (100°C) for about 40 s to be fully softened, then taken out and placed in ice water to be quickly cooled to about 37°C, dried, and shaped according to the auricle morphological characteristics of the child and the orthosis plan. After shaping, wait for it to harden, attach the flexible cushion to the side of the front and rear splints in contact with the ear, and then use medical adhesive tape to bind and adhere the front and rear splints to fix them in front of and behind the auricle.

[0081] Comparative Example 1

[0082] An auricle orthosis, comprising a front splint, a rear splint, and a flexible cushion. The front and rear splints are in a C-shaped structure, and the shape of the flexible cushion is the same as that of the front and rear splints. The front splint, the rear splint, and the flexible cushion have a hole structure, the interval between the holes is 2.5 mm; the aperture of the hole structure is 2 mm. The material of the flexible cushion is selected from sponge, and the thickness of the flexible cushion is 0.5 mm.

[0083] Preparation and use of the auricle orthosis: Under stirring conditions (stirring rate: 30 rpm, time: 10 min), 9.5 kg of terephthalic acid-butylene glycol-succinic acid-1,4-cyclohexanedimethanol copolyester X (weight average molecular weight: 120,000, wherein, based on the total molar number of terephthalic acid and succinic acid repeating units, the content of terephthalic acid repeating units is 60 mol%; based on the total molar number of butylene glycol and 1,4-cyclohexanedimethanol repeating units, the content of 1,4-cyclohexanedimethanol repeating units is 25 mol%) particles, 0.2 kg of jasmine essence and 0.3 kg of low-density polyethylene are mixed. Among them, the molar ratio of the total diacid segment to the total diol segment in the copolyester X is 1:1. The obtained mixture is extruded and pelletized by a twin-screw extruder, the rotation speed of the screw is controlled at 10 rpm, the torque is 20 N*m, and the temperatures of each section of the twin-screw extruder from the feed port to the discharge port are 150 °C, 160 °C, 170 °C, 170 °C, 170 °C, 170 °C in sequence, to obtain the copolyester material A7. The copolyester material A7 is melted and pressed into a C-shaped structure with appropriate dimensions at 170 °C and 1000 MPa, and waits for about 1 hour to completely harden, then the front / rear splint B7 of the auricle orthosis can be obtained. During use, the front splint and the rear splint are placed in boiling water (100 °C) for about 40 s to fully soften them, then taken out and placed in ice water to quickly cool them to about 37 °C, wiped dry, and shaped according to the auricle morphological characteristics of the child and the orthosis plan. After shaping, wait for it to harden, attach the flexible cushion to the side of the front and rear splints in contact with the ear, and then use medical tape to bind and adhere the front and rear splints to fix them in front of and behind the auricle.

[0084] Comparative Example 2

[0085] An auricle orthosis, comprising a front splint, a rear splint and a flexible cushion, the front and rear splints are in a C-shaped structure, and the shape of the flexible cushion is the same as that of the front and rear splints. The front splint, the rear splint and the flexible cushion have a hole structure, the interval between the holes is 2.5 mm; the aperture of the hole structure is 2 mm. The material of the flexible cushion is selected from rubber, and the thickness of the flexible cushion is 0.6 mm.

[0086] Preparation and use of the auricle orthosis: Under stirring conditions (stirring rate: 30 rpm, time: 10 min), 9.5 kg of terephthalic acid-butylene glycol-adipic acid-isosorbide copolyester X (weight-average molecular weight: 130,000, wherein, based on the total molar number of terephthalic acid and adipic acid repeating units, the content of terephthalic acid repeating units is 55 mol%; based on the total molar number of butylene glycol and isosorbide repeating units, the content of isosorbide repeating units is 20 mol%) particles, 0.2 kg of jasmine essence, and 0.3 kg of low-density polyethylene are mixed. Among them, the molar ratio of the total diacid segment to the total diol segment in the copolyester X is 0.9:1. The obtained mixture is extruded and granulated through a twin-screw extruder, the rotation speed of the screw is controlled at 10 rpm, the torque is 20 N*m, and the temperatures of each section from the feed port to the extrusion port in the twin-screw extruder are 150 °C, 160 °C, 170 °C, 170 °C, 170 °C, 170 °C in sequence, to obtain the copolyester material A8. The copolyester material A8 is melted and pressed into a suitable-sized C-shaped structure at 170 °C and 1000 MPa, and waits for about 1 hour to completely harden, then the front / rear splint B8 of the auricle orthosis can be obtained. During use, the front splint and the rear splint are placed in boiling water (100 °C) for about 40 s to fully soften them, then taken out and placed in ice water, quickly cooled to about 37 °C, wiped dry, and shaped according to the ear morphological characteristics of the child and the orthosis plan. After shaping, wait for it to harden, attach the flexible cushion to the side of the front and rear splints in contact with the ear, and then use medical tape to bind and adhere the front and rear splints to fix them in front of and behind the auricle.

[0087] Comparative Example 3

[0088] An auricle orthosis, comprising a front splint, a rear splint, and a flexible cushion. The front and rear splints are in a C-shaped form, and the shape of the flexible cushion is the same as that of the front and rear splints. The front splint, the rear splint, and the flexible cushion have a pore structure, the interval between the pores is 2.5 mm; the pore diameter of the pore structure is 3 mm. The material of the flexible cushion is selected from rubber, and the thickness of the flexible cushion is 0.6 mm.

[0089] Preparation and use of the auricle orthosis: Under stirring conditions (stirring rate: 30 rpm, time: 10 min), 6.5 kg of terephthalic acid-butylene glycol-succinic acid copolyester Y (weight-average molecular weight: 100,000, where the content of terephthalic acid repeating units is 25 mol% based on the total molar number of terephthalic acid and succinic acid repeating units), 3 kg of terephthalic acid-butylene glycol-adipic acid copolyester (weight-average molecular weight: 100,000, where the content of terephthalic acid repeating units is 65 mol% based on the total molar number of terephthalic acid and adipic acid repeating units), 0.2 kg of jasmine essence, and 0.3 kg of low-density polyethylene are mixed. Among them, the molar ratio of the total diacid segment to the total diol segment in the copolyester Y is 0.95:1. The obtained mixture is extruded and pelletized through a twin-screw extruder. The rotation speed of the screw is controlled at 10 rpm, and the torque is 20 N*m. The temperatures of each section from the feed port to the extrusion port in the twin-screw extruder are 150 °C, 160 °C, 170 °C, 170 °C, 170 °C, and 170 °C in sequence to obtain the copolyester material A9. The copolyester material A9 is melted and pressed into a suitable C-shaped structure at 170 °C and 1000 MPa, and waits for about 1 hour to completely harden to obtain the front / rear splint B9 of the auricle orthosis. During use, the front splint and the rear splint are placed in boiling water (100 °C) for about 40 s to fully soften them, then taken out and placed in ice water to quickly cool them to about 37 °C. After drying, they are shaped according to the auricle morphological characteristics of the child and the orthosis plan. After shaping, wait for them to harden. The flexible cushion is attached to the side of the front and rear splints in contact with the ear, and then the front and rear splints are tied and adhered and fixed to the front and rear of the auricle with medical adhesive tape.

[0090] Test Example 1 Softening Temperature Test

[0091] The front / rear splints of the auricle orthosis obtained in Examples 1-6 and Comparative Example 3 are placed in hot water at different temperatures, and the temperatures required to trigger the softening of the front / rear splints of the auricle orthosis are recorded respectively. The results are shown in Table 1.

[0092] Table 1

[0093]

[0094] It can be seen that the temperatures required for the front / rear splints B1-B6 of the auricle orthosis obtained in Examples 1-6 to soften are all lower than those of the front / rear splints B9 of the auricle orthosis obtained in Comparative Example 3, and the maximum decrease can reach 20 °C. Reducing the softening trigger temperature of the front / rear splints of the auricle orthosis can greatly increase the convenience of using the auricle orthosis.

[0095] Test Example 2 Shore A Hardness Test

[0096] After melting the copolyesters A1 - A8 obtained in Examples 1 - 6 and Comparative Examples 1 - 2 respectively, they were processed at 170 °C and 1000 MPa for 5 min, and then pressed into plates with a thickness of 4 mm and a side length of 7 cm. The hot plates were taken out and quenched with cold iron blocks that had been placed at room temperature for a long time for 1 min, and the time zero was recorded. The Shore A hardness of the quenched plates was tested as a function of time (measured with a Drickshore A hand-held hardness tester, and the measurement result after 3 s was taken). The results are shown in Table 2 below.

[0097] Table 2 Shore A Hardness Test

[0098]

[0099] From the results in Table 2 above, it can be seen that the hardness of the copolyesters A1 - A8 obtained in Examples 1 - 6 and Comparative Examples 1 - 2 was relatively low at the beginning of the test (higher temperature), and the hardness increased slowly with time after quenching. Compared with the copolyesters A7 - A8 obtained in Comparative Examples 1 - 2, the curing speed of the copolyesters A1 - A6 obtained in Examples 1 - 6 was faster. It only took about 4 min for the Shore A hardness to reach 50, while the latter took about 7 min. The copolyesters A1 - A6 obtained in Examples 1 - 6 had good plasticity and fixity and were suitable for preparing auricle orthotics.

[0100] Test Example 3 Waterproofness Test

[0101] The front / back splints B1 - B6 of the auricle orthotics obtained in Examples 1 - 6 were weighed, measured for size, photographed, and observed for appearance respectively. The front / back splints were immersed in water at 25 °C for 24 h, then taken out and dried, and then weighed, measured for size, photographed, and observed for appearance. If the appearance of the front / back splints after immersion was unchanged compared with that before immersion, it was recorded as "no change", otherwise it was recorded as "changed". If the change in the size of the front / back splints after immersion was within ±2% compared with that before immersion, it was recorded as "no change", otherwise it was recorded as "changed". If the change in the weight of the front / back splints after immersion was within ±2% compared with that before immersion, it was recorded as "no change", otherwise it was recorded as "changed". The results are shown in Table 3.

[0102] Test Example 4 Shelf Life Test

[0103] Weigh, measure the dimensions, take photos and observe the appearance of the front / rear splints B1 - B6 of the auricle orthosis obtained in Examples 1 - 6 respectively. Then, place the obtained front / rear splints in an environment of normal pressure at room temperature (25°C) for 2 years, and weigh, measure the dimensions, take photos and observe the appearance of the front / rear splints. If there is no change in the appearance of the front / rear splints after 2 years compared with before placement, record it as "no change", otherwise record it as "change". If there is no change in the dimensions of the front / rear splints after 2 years compared with before placement, record it as "no change", otherwise record it as "change". If the change in the weight of the front / rear splints after 2 years compared with before placement is within ±2%, record it as "no change", otherwise record it as "change". The results are shown in Table 3.

[0104] Table 3

[0105]

[0106] It can be seen from the results in Table 3 above that the auricle orthosis provided by the present invention has good waterproofness and dimensional stability. Therefore, it does not require special packaging such as water isolation during storage and transportation; moreover, the shelf life is at least two years under room temperature conditions.

[0107] The present invention has been described in detail above in combination with specific embodiments and exemplary examples, but these descriptions should not be construed as limiting the present invention. Those skilled in the art understand that without departing from the spirit and scope of the present invention, various equivalent substitutions, modifications or improvements can be made to the technical solutions and their implementation manners of the present invention, and these all fall within the scope of the present invention. The protection scope of the present invention shall be subject to the appended claims.

Claims

1. An auricle orthosis, comprising a front splint, a rear splint and a flexible cushion. The front splint and the rear splint are in a C-like shape; the flexible cushion has the same shape as the front splint and the rear splint and is placed on the side where the front splint, the rear splint contact the ear skin when the auricle orthosis is in use. The front splint and the rear splint are made of a copolyester material, and the copolyester material comprises copolyester X and copolyester Y. Wherein the copolyester X comprises an aliphatic diacid segment, an aromatic diacid segment and a glycol segment. The glycol segment includes at least one glycol segment with a cyclic structure segment and at least one aliphatic glycol segment. The molar percentage content of the aromatic diacid segment in the total diacid segment is 25-60%. Wherein the copolyester Y comprises an aliphatic diacid segment, an aromatic diacid segment and at least one aliphatic glycol segment. The molar percentage content of the aromatic diacid segment in the total diacid segment is 60-85%. The copolyester X and the copolyester Y are each independently at least one of a random copolymer, an alternating copolymer, a block copolymer and a graft copolymer. The molecular weight range of the copolyester X and the copolyester Y is 20,000-200,000. Based on 100 parts by weight of the total copolyester, the copolyester X is 55-80 parts, and the copolyester Y is 20-45 parts. The molar percentage content of the glycol segment with a cyclic structure segment in the copolyester X in the total glycol segment is 5-25%. The molar ratio of the total diacid segment to the total glycol segment in the copolyester X is (0.9~1):

1. The molar ratio of the total diacid segment to the total glycol segment in the copolyester Y is (0.9~1):

1. The aliphatic diacid is selected from at least one of 1,4-butanedioic acid and 1,6-hexanedioic acid. The aromatic diacid is selected from terephthalic acid. The glycol with a cyclic structure is selected from at least one of 1,4-cyclohexanedimethanol, isosorbide and 2,2,4,4-tetramethyl-1,3-cyclobutanediol. The aliphatic glycol is selected from at least one of 1,3-propanediol, 1,4-butanediol and 1,6-hexanediol. The aliphatic glycol segment in the copolyester X is different from the aliphatic glycol segment in the copolyester Y.

2. The auricle orthosis according to claim 1, wherein the front splint and the rear splint have or do not have a pore structure; and / or the flexible cushion has or does not have a pore structure.

3. The auricle orthosis according to claim 2, wherein the front splint and the rear splint have a pore structure; and / or the flexible cushion has a pore structure; the pore structure is distributed through the front splint, the rear splint and / or the flexible cushion, and the interval between the pore structures is 1-10 mm; the pore diameter of the pore structure is 1-10 mm.

4. The auricle orthosis according to claim 3, characterized in that, The interval between the pore structures is 2-4 mm; the pore diameter of the pore structure is 1-3 mm.

5. The auricle orthosis according to claim 1, wherein the thickness of the front splint and the rear splint is 0.2-5 mm; and / or the width of the front splint and the rear splint is 5-30 mm.

6. The auricle orthosis according to claim 1, wherein The thickness of the front splint and the rear splint is 0.5 - 3 mm; and / or, The thickness of the flexible buffer pad is 0.1 - 2 mm.

7. The auricle orthosis according to claim 1, wherein The material of the flexible buffer pad is selected from at least one of rubber, sponge, thermoplastic elastomer, cloth, paper, gel, leather, and plasticine; and / or, The thickness of the flexible buffer pad is 0.5 - 1.5 mm.

8. The auricle orthosis according to claim 1, characterized in that, The copolyester X and the copolyester Y are each independently a random copolymer and / or a block copolymer; and / or, the molecular weight range of the copolyester X and the copolyester Y is 80,000 - 150,000.

9. The auricle orthosis according to claim 1, wherein The aliphatic diol segment in the copolyester X is derived from 1,4 - butanediol; the aliphatic diol segment in the copolyester Y is derived from 1,3 - propanediol and / or 1,6 - hexanediol.

10. The auricle orthosis according to claim 1, characterized in that, Based on 100 parts by weight of the total weight of the copolyester X and the copolyester Y, it further contains 0.5 - 10 parts of essence.

11. The auricle orthosis according to claim 10, characterized in that, Essence 1.5 - 8 parts.

12. The auricle orthosis according to claim 1, wherein, Based on 100 parts by weight of the total weight of the copolyester X and the copolyester Y, it further contains 1 - 15 parts of lubricant.

13. The auricle orthosis according to claim 12, characterized in that, Lubricant 5 - 15 parts.

14. The auricle orthosis according to claim 12, characterized in that, The lubricant is selected from at least one of stearic acid, butyl stearate, oleamide, ethylene bisstearamide, and low - density polyethylene.

15. A method for preparing the auricle orthosis according to any one of claims 1 - 14, comprising successively extruding, molding, and / or cutting the copolyester material to obtain the front splint and rear splint profiles of the auricle.

16. The method for preparing the auricle orthosis according to claim 15, wherein The extrusion is melt extrusion; and / or, The temperature of the extrusion is 90 - 230 °C; and / or, The molding method is injection molding and / or compression molding.

17. The preparation method of the auricle orthosis according to claim 16, characterized in that, The temperature of the extrusion is 110 - 170 °C.

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