CN116059027A

CN116059027A - Auricle orthosis and preparation method and application method thereof

Info

Publication number: CN116059027A
Application number: CN202111281785.0A
Authority: CN
Inventors: 侯瑞祥; 郑萃; 祝桂香; 张伟; 韩翎; 张龙贵
Original assignee: Sinopec Beijing Research Institute of Chemical Industry; China Petroleum and Chemical Corp
Current assignee: Sinopec Beijing Research Institute of Chemical Industry; China Petroleum and Chemical Corp
Priority date: 2021-11-01
Filing date: 2021-11-01
Publication date: 2023-05-05

Abstract

The invention relates to an auricle orthosis, a preparation method and a use method thereof, and the auricle orthosis comprises a front splint, a rear splint and a flexible buffer cushion, wherein the front splint and the rear splint are C-shaped; the shape of the flexible buffer cushion is the same as that of the front and rear splints, and the flexible buffer cushion is arranged on one side of the front and rear splints, which is contacted with the skin of the ear when the flexible buffer cushion is used for the auricle orthosis. The hardness of the front clamping plate and the rear clamping plate of the auricle orthosis can be changed along with time and temperature, the auricle orthosis has excellent plasticity, tearing resistance, waterproofness and dimensional stability, has aromatic smell, can better improve user experience, can be recycled, can be degraded after being abandoned, and is environment-friendly.

Description

Auricle orthosis and preparation method and application method thereof

Technical Field

The invention relates to the field of medical rehabilitation nursing instruments, in particular to an auricle orthosis and a preparation method and a use method thereof.

Background

Auricle morphological deformities are common in newborns, mostly caused by congenital causes such as inheritance, pregnancy suffering from metabolic diseases or exposure to certain chemicals and radioactive substances. Common morphological deformities of the auricle include tremella, cup-shaped ear, and tab ear. The auricle morphological deformity is not only an aesthetic defect, but also can cause adverse effects on the physiological and psychological development of the infant. The earlier and better the treatment is, the treatment is carried out within 7 days of birth of the infant, and the correction can be completed within half a month.

The traditional treatment method of congenital auricle deformity is surgery, and has the defects of large wound, poor appearance, high difficulty and the like. In the 80 s of the 20 th century, japanese scholars Matsuo and Kurozumi proposed non-operative treatment schemes, and various splints were used to continuously compress or pull the outer ear, thereby achieving the purpose of orthopedics. The method has the advantages of no wound, simple operation, good curative effect and no rebound, and is a common auricle deformity orthopedic treatment means in clinic.

Currently, most auricle orthoses on the market are made of photosensitive resin materials and are manufactured by using 3D printing technology, such as CN209884505U. This type of auricle orthosis has the following disadvantages: 1) The price of the product is high due to high raw material cost; 2) The preparation method is complex; 3) The plastic has the common taste, and the discomfort of the child patient can be caused by the long-term wearing of the plastic because the ear is close to the nasal cavity; 4) Is not degradable after being abandoned, and is not environment-friendly.

Therefore, the auricle orthosis with the advantages of no peculiar smell, low cost, environmental protection, strong plasticity and the like is very needed.

Disclosure of Invention

In view of the problems of the existing auricle orthoses in the prior art described above, it is an object of the present invention to provide an auricle orthoses which has excellent plasticity, waterproofness and dimensional stability, and at the same time has an aromatic smell, improving the user experience; in addition, the shape can be changed according to the orthopedic requirement in the treatment process, the medical plaster can be recycled, the use cost is reduced, and the waste is degradable and is environment-friendly.

In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:

an auricle orthosis comprises a front splint, a rear splint and a flexible cushion.

In the technical scheme, the front clamping plate and the rear clamping plate are C-shaped; the shape of the flexible buffer cushion is the same as that of the front and rear splints, and the flexible buffer cushion is arranged on one side of the front and rear splints, which is contacted with the skin of the ear when the flexible buffer cushion is used for the auricle orthosis. The flexible buffer cushion is not fixedly connected with the front clamping plate and the rear clamping plate, and the flexible buffer cushion and the front clamping plate and the rear clamping plate are attached together when in use. In addition, the front splint and the rear splint are not fixedly connected, and when the ear canal is used, the front splint and the rear splint are bound and adhered and fixed on the front and the rear of the auricle by adopting adhesive materials such as medical adhesive tapes. The shape of the flexible cushion material may be, but not limited to, rectangular, square, circular sheet-like, etc. with the same size as the ears, and is preferably cut according to the shape of the front and rear splints when in use.

In the above technical solution, the front clamping plate and the rear clamping plate have and/or do not have a hole structure, preferably have a hole structure; the flexible cushioning pad may have and/or may not have a pore structure, preferably a pore structure.

In the technical scheme, the hole structures are in penetrating distribution on the front clamping plate, the rear clamping plate and/or the flexible buffer cushion, and the interval between the holes is 1-10mm, preferably 2-4mm; the pore size of the pore structure is 1-10mm, preferably 1-3mm.

In the case where the front splint and the flexible cushion, or the rear splint and the flexible cushion have hole structures, it is preferable that the hole structures of both are correspondingly penetrated so as to make the auricle orthosis excellent in ventilation.

In the technical scheme, the thicknesses of the front clamping plate and the rear clamping plate are 0.2-5mm, and preferably 0.5-3mm.

In the technical scheme, the widths of the front clamping plate and the rear clamping plate are 5-30mm.

In the above technical solution, the thickness of the flexible buffer pad is 0.1-2mm, preferably 0.5-1.5mm.

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

In the technical scheme, the front clamping plate and the rear clamping plate are made of a copolyester material, and the copolyester material comprises copolyester X and copolyester Y; wherein the copolyester X comprises aliphatic diacid and/or derivative segments thereof, aromatic diacid and/or derivative segments thereof and glycol segments; the diol segment comprises at least one diol segment with a cyclic structure segment and at least one aliphatic diol segment; wherein the aromatic diacid and/or the derivative chain segments thereof account for 15-60 percent of the total diacid and/or the derivative chain segments thereof in mole percent;

wherein the copolyester Y comprises aliphatic diacid and/or derivative segments thereof, aromatic diacid and/or derivative segments thereof, and at least one aliphatic diol segment; wherein the aromatic diacid and/or derivative chain segments thereof account for 50-95 percent of the total diacid and/or derivative chain segments in mole percent. The aromatic diacid content of the copolyester X and the aromatic diacid content of the copolyester Y of the invention are in the above range, and the rigidity of the copolyester can be improved to different degrees.

In the technical scheme, based on 100 parts of total weight of the copolyester, 50-99 parts of the copolyester X, preferably 55-80 parts of the copolyester X; the content of the copolyester X is in the range, so that the temperature required by triggering and softening of the material can be reduced to different degrees, and the hardness and wear resistance of the material are improved;

the content of the copolyester Y is 1-50 parts, preferably 20-45 parts, and the copolyester Y can reduce the time required for curing the copolyester composition material to different degrees within the range.

In the above technical scheme, the aromatic diacid and/or its derivative chain segment in the copolyester X accounts for 25-60% of the total diacid and/or its derivative chain segment in mole percent, and more preferably 30-60%.

Preferably, the diol chain segment with a cyclic structure in the copolyester X accounts for 1-60% of the total diol chain segment by mole, and preferably 5-25%. The introduction of diol with a cyclic structure can increase the rigidity of the copolyester, reduce the temperature required by material triggering softening, and increase the hardness and wear resistance of the material.

Preferably, the mole ratio of the total diacid segments and the total diol segments in the copolyester X is (0.8-1): 1, preferably (0.9 to 1): 1.

preferably, the aromatic diacid and/or derivative chain segments thereof in the copolyester Y account for 60-85 percent of the total diacid and/or derivative chain segments in mole percent.

Preferably, the mole ratio of the total diacid segments and the total diol segments in the copolyester Y is (0.8-1): 1, preferably (0.9 to 1): 1.

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.

In the above technical scheme, the molecular weight of the copolyester X and the copolyester Y ranges from 20000 to 200000, preferably from 80000 to 150000.

In the above technical solution, the aliphatic diacid and/or its derivative is at least one selected from 1, 4-succinic acid and/or its derivative, 1, 6-adipic acid and/or its derivative.

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

The diol with the cyclic structure is at least one selected from 1, 4-cyclohexanedimethanol, isosorbide and 2, 4-tetramethyl 1, 3-cyclobutanediol.

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

The introduction of the diol with the cyclic structure in the single copolyester X can reduce the thickness of the copolyester platelet, thereby reducing the melting point of the copolyester and improving the convenience of the copolyester in use. On the other hand, the introduction of the diol of cyclic structure can reduce the crystallization speed of the copolyester, resulting in an increase in the curing time of the copolyester material.

The copolyester Y alone has shorter curing time than the copolyester X alone, but has higher softening temperature and poorer hardness and wear resistance. Therefore, the composition of the copolyester X and the copolyester Y is adopted to make up the defects of the independent copolyester X or Y, and the proper softening temperature, hardness, wear resistance and curing time of the composition copolyester are obtained by adjusting the proportion of the two.

In the technical scheme, the aliphatic diol chain segment in the copolyester X is different from the aliphatic diol chain segment in the copolyester Y; preferably, the method comprises the steps of,

the aliphatic diol chain segment in the copolyester X is from 1, 4-butanediol; the aliphatic diol chain segments in the copolyester Y are from 1, 3-propanediol and/or 1, 6-hexanediol.

In the technical scheme, the novel polyester further comprises 0.5-10 parts, preferably 1.5-8 parts, of essence based on 100 parts of the total weight of the copolyester X and the copolyester Y.

The essence is at least one selected from fruit essence and flower essence; the fruit essence comprises, but is not limited to, strawberry, banana, sweet orange, pineapple, grape and other types of flavors; the floral essence comprises, but is not limited to, rose, jasmine, tuberose, mugwort, magnolia and other types of fragrances.

In the technical scheme, the novel polyester composite material also comprises 1-15 parts of lubricant based on 100 parts of the total weight of the copolyester X and the copolyester Y, wherein the lubricant is at least one selected from stearic acid, butyl stearate, oleamide, ethylene bis stearamide and low-density polyethylene.

The preparation method of the copolyester material comprises the step of mixing and then melt blending components comprising the copolyester X and the copolyester Y.

In the technical scheme, the mixing is performed under the stirring condition, and the stirring speed is 20-150r/min.

In the technical scheme, the stirring time is 5-15min.

In the technical scheme, the melt blending is carried out in a mode of extrusion granulation through a double-screw extruder; preferably, the temperature of the extrusion granulation is 110 to 260 ℃, more preferably 160 to 220 ℃.

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

a method of making an auricle orthosis comprising sequentially extruding, shaping and/or cutting a copolyester material to obtain anterior and posterior splint profiles for the auricle orthosis, the extrusion preferably being melt extrusion.

In the technical scheme, the extrusion temperature is 90-230 ℃, preferably 110-170 ℃;

the molding mode is injection molding and/or compression molding. The equipment also adopts extrusion, injection molding and compression molding equipment commonly used in the prior art.

The invention also provides a using method of the auricle orthosis, which comprises the steps of heating the front splint section bar and the rear splint section bar of the auricle orthosis to fully soften the front splint section bar and the rear splint section bar, then rapidly reducing the temperature to be acceptable for human body, and shaping according to the morphological characteristics of the ear of the infant and the orthopedic scheme; and after the shaping is finished, hardening the material.

Preferably, the anterior splint profile of the auricle is heated to be fully softened, and the heating method comprises, but is not limited to, soaking in hot water, especially boiling water, heating in a microwave oven, an oven, a hot plate and the like; then rapidly cooling to acceptable temperature for human body, wherein the cooling method comprises, but is not limited to, soaking in cold water, ice water or liquid nitrogen, contacting with ice cubes or ice bags, and placing in a refrigerator refrigerating chamber or freezing chamber or ice chest; then wiping cleanly, and shaping according to the morphological characteristics of the ear parts of the children patients and the orthopedic scheme; and after the shaping is finished, hardening the front clamping plate to obtain the front clamping plate. The same method can obtain the rear clamping plate. When in use, the front and rear splints are bound and adhered and fixed on the front and rear auricles by using medical adhesive tapes.

The invention has the beneficial effects that:

1. the cost is low;

2. the preparation method is simple and convenient;

3. the fragrance smell is provided, and the user experience is good;

4. can be recycled, can be degraded after being abandoned, and is environment-friendly.

Drawings

Fig. 1 is a schematic view of the structure of the auricle orthosis of the present invention.

Reference numerals: 1. front/back splints, 2. Flexible cushion material, 3. Ventilation holes. The front clamping plate and the rear clamping plate are C-like in shape; the shape of the flexible buffer cushion is the same as that of the front clamping plate and the rear clamping plate.

Detailed Description

The present invention is described in detail below with reference to specific embodiments, and it should be noted that the following embodiments are only for further description of the present invention and should not be construed as limiting the scope of the present invention, and some insubstantial modifications and adjustments of the present invention by those skilled in the art from the present disclosure are still within the scope of the present invention.

In addition, the specific features described in the following embodiments may be combined in any suitable manner without contradiction. The various possible combinations of the invention are not described in detail in order to avoid unnecessary repetition.

In addition, any combination of the various embodiments of the present invention can be made, so long as the concept of the present invention is not deviated, and the technical solution formed thereby is a part of the original disclosure of the present specification, and also falls within the protection scope of the present invention.

Reagent source: the reagents used in the present invention are all commercially available.

In the following examples and comparative examples, the weight average molecular weight of the polymer was measured on a Waters-208 (with Waters 2410RI detector, 1.5mL/min flow rate, 30 ℃) instrument using Gel Permeation Chromatography (GPC) with Tetrahydrofuran (THF) as solvent, calibrated with styrene standards.

The composition of the polyester composition is determined by the feed of the raw materials; the types of the reaction raw materials can be correspondingly adjusted according to the composition and the molecular weight of a target product, and the molecular weight of the product and the content of each repeating unit in the product can be respectively controlled by adjusting the feeding amount and the feeding ratio.

Example 1

An auricle orthosis comprises a front splint, a rear splint and a flexible cushion, wherein the front splint and the rear splint are in a C-like shape, and the shape of the flexible cushion is the same as that of the front splint and the rear splint. The front clamping plate, the rear clamping plate and the flexible buffer cushion are provided with hole structures, and the intervals among the holes are 2.5mm; the pore diameter of the pore structure is 2mm. The material of the flexible cushion pad is selected from sponge, and the thickness of the flexible cushion pad is 0.5mm.

The auricle orthosis is prepared and used: 7kg of terephthalic acid-butanediol-succinic acid-1, 4-cyclohexanedimethanol copolyester X (weight average molecular weight: 120,000, wherein the content of terephthalic acid repeating units was 60 mol% based on the total number of moles of terephthalic acid and succinic acid repeating units, and the content of 1, 4-cyclohexanedimethanol repeating units was 25 mol% based on the total number of moles of butanediol and 1, 4-cyclohexanedimethanol repeating units) was mixed with particles, 2.5kg of terephthalic acid-propanediol-succinic acid copolyester Y (weight average molecular weight: 100,000, wherein the content of terephthalic acid repeating units was 60 mol% based on the total number of moles of terephthalic acid and succinic acid repeating units), 0.2kg of jasmine essence and 0.3kg of low-density polyethylene under stirring (stirring rate: 30rpm, time: 10 min). Wherein the mole ratio of the total diacid chain segments to the total diol chain segments in the copolyester X is 0.95:1, and the mole ratio of the total diacid chain segments to the total diol chain segments in the copolyester Y is 0.95:1. Extruding and granulating the obtained mixture by a double-screw extruder, wherein the rotating speed of the screw is controlled to be 10rpm, the torque is 20N x m, and the temperatures of all sections from a feed inlet to an extrusion outlet in the double-screw extruder are 150 ℃, 160 ℃, 170 ℃ and 170 ℃ in sequence, so as to prepare the copolyester material A1. The copolyester material A1 is melted and pressed into a C-shaped structure with proper size at 170 ℃ and 1000MPa, and the front/back splint B1 of the auricle orthosis can be obtained after waiting for about 1 hour to harden completely. When in use, the front splint and the rear splint are placed in boiled water (100 ℃) for about 40 seconds to fully soften the front splint and the rear splint, then are taken out and placed in ice water, are rapidly cooled to about 37 ℃, are shaped according to the morphological characteristics and the orthopedic scheme of the ears of the child after being wiped, are hardened after the shaping is finished, the flexible buffer cushion is attached to one side of the front splint and the rear splint, which is contacted with the ears, and then the front splint and the rear splint are bound and adhered and fixed on the front and the rear of the auricle by adopting medical adhesive tape.

Example 2

An auricle orthosis comprises a front splint, a rear splint and a flexible cushion, wherein the front splint and the rear splint are in a C-like shape, and the shape of the flexible cushion is the same as that of the front splint and the rear splint. The front clamping plate, the rear clamping plate and the flexible buffer cushion are provided with hole structures, and the intervals among the holes are 2mm; the pore diameter of the pore structure is 2mm. The material of the flexible cushion pad is selected from sponge, and the thickness of the flexible cushion pad is 0.8mm.

The auricle orthosis is prepared and used: under stirring (stirring speed: 30rpm, time: 10 min), 6.5kg of terephthalic acid-butanediol-adipic acid-isosorbide copolyester X (weight average molecular weight: 130,000, wherein the content of terephthalic acid repeating units was 55 mol% based on the total mole number of terephthalic acid and adipic acid repeating units, and the content of isosorbide repeating units was 20 mol% based on the total mole number of butanediol and isosorbide repeating units), 3kg of terephthalic acid-hexanediol-succinic acid copolyester Y (weight average molecular weight: 100,000, wherein the content of terephthalic acid repeating units was 60 mol% based on the total mole number of terephthalic acid and succinic acid repeating units), 0.2kg of jasmine essence and 0.3kg of low density polyethylene were mixed. Wherein the mole ratio of the total diacid chain segments to the total diol chain segments in the copolyester X is 1:1, and the mole ratio of the total diacid chain segments to the total diol chain segments in the copolyester Y is 1:1. Extruding and granulating the obtained mixture by a double-screw extruder, wherein the rotating speed of the screw is controlled to be 10rpm, the torque is 20N x m, and the temperatures of all sections from a feed inlet to an extrusion outlet in the double-screw extruder are 150 ℃, 160 ℃, 170 ℃ and 170 ℃ in sequence, so as to prepare the copolyester material A2. The copolyester material A2 is melted and pressed into a C-shaped structure with proper size at 170 ℃ and 1000MPa, and the front/back splint B2 of the auricle orthosis can be obtained after waiting for about 1 hour to harden completely. When in use, the front splint and the rear splint are placed in boiled water (100 ℃) for about 40 seconds to fully soften the front splint and the rear splint, then are taken out and placed in ice water, are rapidly cooled to about 37 ℃, are shaped according to the morphological characteristics and the orthopedic scheme of the ears of the child after being wiped, are hardened after the shaping is finished, the flexible buffer cushion is attached to one side of the front splint and the rear splint, which is contacted with the ears, and then the front splint and the rear splint are bound and adhered and fixed on the front and the rear of the auricle by adopting medical adhesive tape.

Example 3

An auricle orthosis comprises a front splint, a rear splint and a flexible cushion, wherein the front splint and the rear splint are in a C-like shape, and the shape of the flexible cushion is the same as that of the front splint and the rear splint. The front clamping plate, the rear clamping plate and the flexible buffer cushion are provided with hole structures, and the intervals among the holes are 2.5mm; the pore diameter of the pore structure is 2mm. The material of the flexible buffer cushion is selected from rubber, and the thickness of the flexible buffer cushion is 0.6mm.

The auricle orthosis is prepared and used: under stirring (stirring speed: 30rpm, time: 10 min), 6.5kg of terephthalic acid-butanediol-succinic acid-2, 4-tetramethyl-1, 3-cyclobutanediol copolyester X (weight average molecular weight: 150,000, wherein the content of terephthalic acid repeating units was 30 mol% based on the total mole number of terephthalic acid and succinic acid repeating units); the pellets of 2, 4-tetramethyl 1, 3-cyclobutanediol repeat unit content of 20 mol% based on the total mole number of butanediol and 2, 4-tetramethyl 1, 3-cyclobutanediol repeat unit content, 3kg of terephthalic acid-hexanediol-succinic acid copolyester Y (weight average molecular weight: 100,000, wherein terephthalic acid repeat unit content of 60 mol% based on the total mole number of terephthalic acid and succinic acid repeat unit content) and 0.2kg of jasmine essence were mixed with 0.3kg of low-density polyethylene. Wherein the mole ratio of the total diacid chain segments to the total diol chain segments in the copolyester X is 0.9:1, and the mole ratio of the total diacid chain segments to the total diol chain segments in the copolyester Y is 0.9:1. Extruding and granulating the obtained mixture by a double-screw extruder, wherein the rotating speed of the screw is controlled to be 10rpm, the torque is 20N x m, and the temperatures of all sections from a feed inlet to an extrusion outlet in the double-screw extruder are 150 ℃, 160 ℃, 170 ℃ and 170 ℃ in sequence, so as to prepare the copolyester material A3. The copolyester material A3 is melted and pressed into a C-shaped structure with proper size at 170 ℃ and 1000MPa, and the front/back splint B3 of the auricle orthosis can be obtained after waiting for about 1 hour to harden completely. When in use, the front splint and the rear splint are placed in boiled water (100 ℃) for about 40 seconds to fully soften the front splint and the rear splint, then are taken out and placed in ice water, are rapidly cooled to about 37 ℃, are shaped according to the morphological characteristics and the orthopedic scheme of the ears of the child after being wiped, are hardened after the shaping is finished, the flexible buffer cushion is attached to one side of the front splint and the rear splint, which is contacted with the ears, and then the front splint and the rear splint are bound and adhered and fixed on the front and the rear of the auricle by adopting medical adhesive tape.

Example 4

An auricle orthosis comprises a front splint, a rear splint and a flexible cushion, wherein the front splint and the rear splint are in a C-like shape, and the shape of the flexible cushion is the same as that of the front splint and the rear splint. The front clamping plate, the rear clamping plate and the flexible buffer cushion are provided with hole structures, and the intervals among the holes are 2mm; the pore diameter of the pore structure is 2.5mm. The material of the flexible buffer cushion is selected from rubber, and the thickness of the flexible buffer cushion is 0.6mm.

The auricle orthosis is prepared and used: 7kg of terephthalic acid-butanediol-succinic acid-1, 4-cyclohexanedimethanol copolyester X (weight average molecular weight: 120,000, wherein the content of terephthalic acid repeating units was 60 mol% based on the total number of moles of terephthalic acid and succinic acid repeating units, and the content of 1, 4-cyclohexanedimethanol repeating units was 25 mol% based on the total number of moles of butanediol and 1, 4-cyclohexanedimethanol repeating units) was mixed with particles, 2.5kg of terephthalic acid-propanediol-succinic acid copolyester Y (weight average molecular weight: 110,000, wherein the content of terephthalic acid repeating units was 80 mol% based on the total number of moles of terephthalic acid and succinic acid repeating units), 0.2kg of jasmine essence and 0.3kg of low-density polyethylene under stirring (stirring rate: 30rpm, time: 10 min). Wherein the molar ratio of the total diacid chain segments to the total diol chain segments in the copolyester X is 0.95:1, and the molar ratio of the total diacid chain segments to the total diol chain segments in the copolyester Y is 1:1. Extruding and granulating the obtained mixture by a double-screw extruder, wherein the rotating speed of the screw is controlled to be 10rpm, the torque is 20N x m, and the temperatures of all sections from a feed inlet to an extrusion outlet in the double-screw extruder are 150 ℃, 160 ℃, 170 ℃ and 170 ℃ in sequence, so as to prepare the copolyester material A4. The copolyester material A4 is melted and pressed into a C-shaped structure with proper size at 170 ℃ and 1000MPa, and the front/back splint B4 of the auricle orthosis can be obtained after waiting for about 1 hour to harden completely. When in use, the front splint and the rear splint are placed in boiled water (100 ℃) for about 40 seconds to fully soften the front splint and the rear splint, then are taken out and placed in ice water, are rapidly cooled to about 37 ℃, are shaped according to the morphological characteristics and the orthopedic scheme of the ears of the child after being wiped, are hardened after the shaping is finished, the flexible buffer cushion is attached to one side of the front splint and the rear splint, which is contacted with the ears, and then the front splint and the rear splint are bound and adhered and fixed on the front and the rear of the auricle by adopting medical adhesive tape.

Example 5

The auricle orthosis is prepared and used: 7kg of terephthalic acid-butanediol-succinic acid-2, 4-tetramethyl-1, 3-cyclobutanediol copolyester X (weight average molecular weight: 150,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total number of moles of terephthalic acid and succinic acid repeating units) was stirred at 30rpm for 10 min; 2.5kg of particles of terephthalic acid-propylene glycol-succinic acid copolyester Y (weight average molecular weight: 100,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total number of moles of terephthalic acid and succinic acid repeating units), 0.2kg of jasmine essence and 0.3kg of low-density polyethylene were mixed based on the total number of moles of butanediol and 2, 4-tetramethyl 1, 3-cyclobutanediol repeating units. Wherein the mole ratio of the total diacid chain segments to the total diol chain segments in the copolyester X is 1:1, and the mole ratio of the total diacid chain segments to the total diol chain segments in the copolyester Y is 0.9:1. Extruding and granulating the obtained mixture by a double-screw extruder, wherein the rotating speed of the screw is controlled to be 10rpm, the torque is 20N x m, and the temperatures of all sections from a feed inlet to an extrusion outlet in the double-screw extruder are 150 ℃, 160 ℃, 170 ℃ and 170 ℃ in sequence, so as to prepare the copolyester material A5. The copolyester material A5 is melted and pressed into a C-shaped structure with proper size at 170 ℃ and 1000MPa, and the front/back splint B5 of the auricle orthosis can be obtained after waiting for about 1 hour to harden completely. When in use, the front splint and the rear splint are placed in boiled water (100 ℃) for about 40 seconds to fully soften the front splint and the rear splint, then are taken out and placed in ice water, are rapidly cooled to about 37 ℃, are shaped according to the morphological characteristics and the orthopedic scheme of the ears of the child after being wiped, are hardened after the shaping is finished, the flexible buffer cushion is attached to one side of the front splint and the rear splint, which is contacted with the ears, and then the front splint and the rear splint are bound and adhered and fixed on the front and the rear of the auricle by adopting medical adhesive tape.

Example 6

An auricle orthosis comprises a front splint, a rear splint and a flexible cushion, wherein the front splint and the rear splint are in a C-like shape, and the shape of the flexible cushion is the same as that of the front splint and the rear splint. The front clamping plate, the rear clamping plate and the flexible buffer cushion are provided with hole structures, and the intervals among the holes are 2.5mm; the pore diameter of the pore structure is 3mm. The material of the flexible cushion pad is selected from gel, and the thickness of the flexible cushion pad is 0.6mm.

The auricle orthosis is prepared and used: 7kg of terephthalic acid-butanediol-succinic acid-isosorbide copolyester X (weight average molecular weight: 130,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total number of moles of terephthalic acid and succinic acid repeating units, and the content of isosorbide repeating units is 5 mol% based on the total number of moles of butanediol and isosorbide repeating units) and 2.5kg of terephthalic acid-propanediol-succinic acid copolyester Y (weight average molecular weight: 100,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total number of moles of terephthalic acid and succinic acid repeating units) were mixed with 0.3kg of low-density polyethylene under stirring (stirring rate: 30rpm, time: 10 min). Wherein the mole ratio of the total diacid chain segments to the total diol chain segments in the copolyester X is 0.95:1, and the mole ratio of the total diacid chain segments to the total diol chain segments in the copolyester Y is 0.9:1. Extruding and granulating the obtained mixture by a double-screw extruder, wherein the rotating speed of the screw is controlled to be 10rpm, the torque is 20N x m, and the temperatures of all sections from a feed inlet to an extrusion outlet in the double-screw extruder are 150 ℃, 160 ℃, 170 ℃ and 170 ℃ in sequence, so as to prepare the copolyester material A6. The copolyester material A6 is melted and pressed into a C-shaped structure with proper size at 170 ℃ and 1000MPa, and the front/back splint B6 of the auricle orthosis can be obtained after waiting for about 1 hour to harden completely. When in use, the front splint and the rear splint are placed in boiled water (100 ℃) for about 40 seconds to fully soften the front splint and the rear splint, then are taken out and placed in ice water, are rapidly cooled to about 37 ℃, are shaped according to the morphological characteristics and the orthopedic scheme of the ears of the child after being wiped, are hardened after the shaping is finished, the flexible buffer cushion is attached to one side of the front splint and the rear splint, which is contacted with the ears, and then the front splint and the rear splint are bound and adhered and fixed on the front and the rear of the auricle by adopting medical adhesive tape.

Comparative example 1

The auricle orthosis is prepared and used: 9.5kg of terephthalic acid-butanediol-succinic acid-1, 4-cyclohexanedimethanol copolyester X (weight average molecular weight 120,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total number of moles of terephthalic acid and succinic acid repeating units and the content of 1, 4-cyclohexanedimethanol repeating units is 25 mol% based on the total number of moles of butanediol and 1, 4-cyclohexanedimethanol repeating units) particles, 0.2kg of jasmine essence and 0.3kg of low density polyethylene were mixed under stirring (stirring rate: 30rpm, time: 10 min). Wherein the mole ratio of the total diacid chain segments to the total diol chain segments in the copolyester X is 1:1. Extruding and granulating the obtained mixture by a double-screw extruder, wherein the rotating speed of the screw is controlled to be 10rpm, the torque is 20N x m, and the temperatures of all sections from a feed inlet to an extrusion outlet in the double-screw extruder are 150 ℃, 160 ℃, 170 ℃ and 170 ℃ in sequence, so as to prepare the copolyester material A7. The copolyester material A7 is melted and pressed into a C-shaped structure with proper size at 170 ℃ and 1000MPa, and the front/back splint B7 of the auricle orthosis can be obtained after waiting for about 1 hour to harden completely. When in use, the front splint and the rear splint are placed in boiled water (100 ℃) for about 40 seconds to fully soften the front splint and the rear splint, then are taken out and placed in ice water, are rapidly cooled to about 37 ℃, are shaped according to the morphological characteristics and the orthopedic scheme of the ears of the child after being wiped, are hardened after the shaping is finished, the flexible buffer cushion is attached to one side of the front splint and the rear splint, which is contacted with the ears, and then the front splint and the rear splint are bound and adhered and fixed on the front and the rear of the auricle by adopting medical adhesive tape.

Comparative example 2

The auricle orthosis is prepared and used: 9.5kg of terephthalic acid-butanediol-adipic acid-isosorbide copolyester X (weight average molecular weight 130,000, wherein the content of terephthalic acid repeating units is 55 mol% based on the total number of moles of terephthalic acid and adipic acid repeating units, and the content of isosorbide repeating units is 20 mol% based on the total number of moles of butanediol and isosorbide repeating units) were mixed with stirring (stirring rate: 30rpm, time: 10 min), and 0.2kg of jasmine essence and 0.3kg of low density polyethylene. Wherein the mole ratio of the total diacid chain segments to the total diol chain segments in the copolyester X is 0.9:1. Extruding and granulating the obtained mixture by a double-screw extruder, wherein the rotating speed of the screw is controlled to be 10rpm, the torque is 20N x m, and the temperatures of all sections from a feed inlet to an extrusion outlet in the double-screw extruder are 150 ℃, 160 ℃, 170 ℃ and 170 ℃ in sequence, so as to prepare the copolyester material A8. The copolyester material A8 is melted and pressed into a C-shaped structure with proper size at 170 ℃ and 1000MPa, and the front/back splint B8 of the auricle orthosis can be obtained after waiting for about 1 hour to harden completely. When in use, the front splint and the rear splint are placed in boiled water (100 ℃) for about 40 seconds to fully soften the front splint and the rear splint, then are taken out and placed in ice water, are rapidly cooled to about 37 ℃, are shaped according to the morphological characteristics and the orthopedic scheme of the ears of the child after being wiped, are hardened after the shaping is finished, the flexible buffer cushion is attached to one side of the front splint and the rear splint, which is contacted with the ears, and then the front splint and the rear splint are bound and adhered and fixed on the front and the rear of the auricle by adopting medical adhesive tape.

Comparative example 3

An auricle orthosis comprises a front splint, a rear splint and a flexible cushion, wherein the front splint and the rear splint are in a C-like shape, and the shape of the flexible cushion is the same as that of the front splint and the rear splint. The front clamping plate, the rear clamping plate and the flexible buffer cushion are provided with hole structures, and the intervals among the holes are 2.5mm; the pore diameter of the pore structure is 3mm. The material of the flexible buffer cushion is selected from rubber, and the thickness of the flexible buffer cushion is 0.6mm.

The auricle orthosis is prepared and used: under stirring (stirring rate: 30rpm, time: 10 min), 6.5kg of terephthalic acid-butanediol-succinic acid copolyester Y (weight average molecular weight: 100,000, wherein the content of terephthalic acid repeating units was 25 mol% based on the total mole number of terephthalic acid and succinic acid repeating units) particles, 3kg of terephthalic acid-butanediol-adipic acid copolyester (weight average molecular weight: 100,000, wherein the content of terephthalic acid repeating units was 65 mol% based on the total mole number of terephthalic acid and adipic acid repeating units) particles, 0.2kg of jasmine essence and 0.3kg of low-density polyethylene were mixed. Wherein the mole ratio of the total diacid chain segments to the total diol chain segments in the copolyester Y is 0.95:1. Extruding and granulating the obtained mixture by a double-screw extruder, wherein the rotating speed of the screw is controlled to be 10rpm, the torque is 20N x m, and the temperatures of all sections from a feed inlet to an extrusion outlet in the double-screw extruder are 150 ℃, 160 ℃, 170 ℃ and 170 ℃ in sequence, so as to prepare the copolyester material A9. The copolyester material A9 is melted and pressed into a C-shaped structure with proper size at 170 ℃ and 1000MPa, and the front/back splint B9 of the auricle orthosis can be obtained after waiting for about 1 hour to harden completely. When in use, the front splint and the rear splint are placed in boiled water (100 ℃) for about 40 seconds to fully soften the front splint and the rear splint, then are taken out and placed in ice water, are rapidly cooled to about 37 ℃, are shaped according to the morphological characteristics and the orthopedic scheme of the ears of the child after being wiped, are hardened after the shaping is finished, the flexible buffer cushion is attached to one side of the front splint and the rear splint, which is contacted with the ears, and then the front splint and the rear splint are bound and adhered and fixed on the front and the rear of the auricle by adopting medical adhesive tape.

Test example 1 softening temperature test

The anterior/posterior splints of the auricle orthoses obtained in examples 1 to 6 and comparative example 3 were placed in hot water at different temperatures, and the temperatures required to trigger softening of the anterior/posterior splints of the auricle orthoses were recorded, respectively, and the results are shown in table 1.

TABLE 1

It can be seen that the temperatures required for softening the anterior/posterior auricular orthoses B1 to B6 obtained in examples 1 to 6 are lower than those required for softening the anterior/posterior auricular orthoses B9 obtained in comparative example 3, and the maximum amplitude reduction can be up to 20 ℃. Reducing the anterior/posterior splint softening trigger temperature of the auricle orthosis can greatly increase the convenience of use of the auricle orthosis.

Test example 2 Shore A hardness test

The copolyesters A1 to A8 obtained in examples 1 to 6 and comparative examples 1 to 2 were melted and then treated at 170℃and 1000MPa for 5 minutes, and pressed into a sheet having a thickness of 4mm and a side length of 7 cm. And taking out the hot plate, quenching the plate for 1min by using a chill block placed at room temperature for a long time, and recording a time zero point. The quenched sheet was subjected to a time-dependent test of Shore A hardness (measurement with a drug Shore A hand-held durometer, measurement after 3 seconds) and the results are shown in Table 2 below.

Table 2 shore a hardness test

As can be seen from the results of Table 2 above, the copolyesters A1-A8 obtained in examples 1-6 and comparative examples 1-2 were all lower in hardness at the beginning of the test (higher temperature) and increased slowly with time after cold treatment. Compared with the copolyesters A7-A8 obtained in comparative examples 1-2, the copolyesters A1-A6 obtained in examples 1-6 have a faster curing speed, and only about 4 minutes are required for the Shore A hardness to reach 50, the latter requiring about 7 minutes. The copolyesters A1-A6 obtained in examples 1-6 have good plasticity and fixity and are suitable for preparing auricle orthoses.

Test example 3 Water repellency test

The anterior/posterior splints B1-B6 of the auricle orthoses obtained in examples 1-6 were weighed, sized, photographed, and observed in appearance, respectively. The front/rear splints were immersed in 25 ℃ water for 24 hours, then removed for air-drying, observed for weighing, measured for size, photographed and observed for appearance. The appearance of the front/rear splints after immersion was recorded as "unchanged" if there was no change from before immersion, otherwise "changed". The "no change" is recorded if the size of the post-immersion front/rear clamp plate is within + -2% of the size of the pre-immersion clamp plate, otherwise the "change" is recorded. If the weight of the fore/aft splints after immersion is within + -2% of before immersion, then no change is noted, otherwise a change is noted. The results are shown in Table 3.

Test example 4 shelf life test

The anterior/posterior splints B1-B6 of the auricle orthoses obtained in examples 1-6 were weighed, sized, photographed, and observed in appearance, respectively. The resulting front/rear splints were then placed in a room temperature (25 ℃) atmospheric environment for 2 years, the front/rear splints were weighed, measured in size, photographed and observed in appearance. If the appearance of the splint did not change before/after 2 years of placement compared to before placement, it was recorded as "no change", otherwise it was recorded as "changed". If the dimensions of the panel did not change after 2 years of placement as compared to before placement, no change was noted, otherwise a change was noted. If the weight of the splint before/after 2 years of placement was within + -2% of before placement, it was recorded as "no change", otherwise it was recorded as "changed". The results are shown in Table 3.

TABLE 3 Table 3

From the results of table 3 above, it can be seen that the auricle orthosis provided by the present invention has good waterproof property and dimensional stability, so that it does not need special packaging such as water blocking during storage and transportation; and, shelf life at room temperature for at least two years.

The invention has been described in detail in connection with the specific embodiments and exemplary examples thereof, but such description is not to be construed as limiting the invention. It will be understood by those skilled in the art that various equivalent substitutions, modifications or improvements may be made to the technical solution of the present invention and its embodiments without departing from the spirit and scope of the present invention, and these fall within the scope of the present invention. The scope of the invention is defined by the appended claims.

Claims

1. An auricle orthosis comprises a front splint, a rear splint and a flexible cushion, wherein the front splint and the rear splint are C-shaped; the shape of the flexible buffer cushion is the same as that of the front and rear splints, and the flexible buffer cushion is arranged on one side of the front and rear splints, which is contacted with the skin of the ear when the flexible buffer cushion is used for the auricle orthosis.

2. The auricle orthosis of claim 1, wherein,

the front and rear splints have and/or do not have a hole structure, preferably a hole structure; and/or the number of the groups of groups,

the flexible cushioning pad may have and/or may not have a pore structure, preferably a pore structure.

3. The auricle orthosis of claim 2, wherein,

the hole structures are arranged on the front clamping plate, the rear clamping plate and/or the flexible buffer cushion in a penetrating way, and the interval between the holes is 1-10mm, preferably 2-4mm; the pore size of the pore structure is 1-10mm, preferably 1-3mm.

4. The auricle orthosis of claim 1, wherein,

the thickness of the front clamping plate and the rear clamping plate is 0.2-5mm, preferably 0.5-3mm; and/or the number of the groups of groups,

the width of the front clamping plate and the rear clamping plate is 5-30mm.

5. The auricle orthosis of claim 1, wherein,

the flexible cushion pad is made of at least one of rubber, sponge, thermoplastic elastomer, cloth, paper, gel, leather and plasticine; and/or the number of the groups of groups,

the thickness of the flexible cushion is 0.1-2mm, preferably 0.5-1.5mm.

6. The auricle orthosis of claim 1, wherein the anterior and posterior splints are made of a copolyester material comprising copolyester X and copolyester Y; wherein the copolyester X comprises aliphatic diacid and/or derivative segments thereof, aromatic diacid and/or derivative segments thereof and glycol segments; the diol segment comprises at least one diol segment with a cyclic structure segment and at least one aliphatic diol segment; wherein the aromatic diacid and/or derivative chain segments thereof account for 15-60 percent of the total diacid and/or derivative chain segments thereof in mole percent;

wherein the copolyester Y comprises aliphatic diacid and/or derivative segments thereof, aromatic diacid and/or derivative segments thereof, and at least one aliphatic diol segment; wherein the aromatic diacid and/or derivative chain segments thereof account for 50-95 percent of the total diacid and/or derivative chain segments in mole percent.

7. The auricle orthosis according to claim 6, characterized in that 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; and/or the molecular weight of the copolyester X and the copolyester Y ranges from 20000 to 200000, preferably from 80000 to 150000.

8. The auricle orthosis according to claim 6, characterized in that the copolyester X is 50-99 parts, preferably 55-80 parts, based on 100 parts total weight of copolyester; and/or the copolyester Y is 1 to 50 parts, preferably 20 to 45 parts.

9. The auricle orthosis according to claim 6, characterized in that the aromatic diacid and/or its derivative segments in the copolyester X account for 25-60% by mole of the total diacid and/or its derivative segments; and/or the number of the groups of groups,

the diol chain segment with a cyclic structure in the copolyester X accounts for 1-60% of the total diol chain segment in mole percent, and is preferably 5-25%; and/or the number of the groups of groups,

the mole ratio of the total diacid chain segments to the total diol chain segments in the copolyester X is (0.8-1): 1, preferably (0.9 to 1): 1, a step of; and/or the number of the groups of groups,

the aromatic diacid and/or derivative chain segments thereof in the copolyester Y account for 60-85 percent of the total diacid and/or derivative chain segments thereof in mole percent; and/or the number of the groups of groups,

the mole ratio of the total diacid chain segments and the total diol chain segments in the copolyester Y is (0.8-1): 1, preferably (0.9 to 1): 1.

10. the auricle orthosis according to claim 6, characterized in that the aliphatic diacid and/or the derivative thereof is selected from at least one of 1, 4-succinic acid and/or the derivative thereof, 1, 6-adipic acid and/or the derivative thereof; and/or the number of the groups of groups,

the aromatic diacid and/or its derivative is selected from terephthalic acid and/or its derivative; and/or the number of the groups of groups,

the diol with the cyclic structure is at least one selected from 1, 4-cyclohexanedimethanol, isosorbide and 2, 4-tetramethyl 1, 3-cyclobutanediol; and/or the number of the groups of groups,

11. The auricle orthosis of claim 10, wherein the aliphatic diol segments in the copolyester X are different from the aliphatic diol segments in the copolyester Y; preferably, the method comprises the steps of,

12. The auricle orthosis according to claim 6, further comprising 0.5-10 parts, preferably 1.5-8 parts of perfume based on 100 parts total weight of copolyester X and copolyester Y.

13. The auricle orthosis according to claim 6, characterized in that it further comprises 1 to 15 parts, preferably 5 to 15 parts, of a lubricant, preferably at least one selected from stearic acid, butyl stearate, oleamide, ethylenebisstearamide and low-density polyethylene, based on 100 parts by total weight of copolyester X and copolyester Y.

14. A method of making an auricle orthosis according to any one of claims 1 to 13, comprising subjecting the copolyester material to extrusion, preferably melt extrusion, in sequence, forming and/or cutting to obtain anterior and posterior splint profiles of the auricle.

15. A method of making an auricle orthosis according to claim 14, characterized in that,

the extrusion temperature is 90-230 ℃, preferably 110-170 ℃; and/or the number of the groups of groups,

the molding mode is injection molding and/or compression molding.

16. A method of using an auricle orthosis according to any one of claims 1 to 13, comprising heating the anterior and posterior splint profiles of the auricle orthosis to soften them sufficiently and then rapidly cooling them to a temperature acceptable to the human body, shaping according to the morphological characteristics of the ear of the infant and the orthosis; after the shaping is finished, the soft cushion pad is taken down from the ear of the infant after the soft cushion pad is hardened, the soft cushion pad is cut into a front clamping plate shape and a rear clamping plate shape, the front clamping plate and the rear clamping plate are respectively arranged on the skin attaching sides of the ear, and then the soft cushion pad is fixed on the ear of the infant for correction.