CN108371576B - Auricle orthosis and preparation method thereof - Google Patents
Auricle orthosis and preparation method thereof Download PDFInfo
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- CN108371576B CN108371576B CN201810073246.XA CN201810073246A CN108371576B CN 108371576 B CN108371576 B CN 108371576B CN 201810073246 A CN201810073246 A CN 201810073246A CN 108371576 B CN108371576 B CN 108371576B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
- A61F5/01—Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
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Abstract
The invention discloses an auricle orthosis and a preparation method thereof, the auricle orthosis comprises a base and a fixer, the base is arranged on the inner side of the auricle near the head, the fixer is arranged on the outer side of the auricle, one part of the fixer clamps the auricle, the other part of the fixer is attached to the base, the base is of a combined structure and consists of a base main body and a base framework embedded in the base main body, the base main body is of a hollow structure with a cavity, the base framework is embedded in the cavity of the base main body, the base framework is used as a framework of the whole base and can bear external force, the fixer is also of a combined structure and consists of a fixer main body and a fixer framework embedded in the fixer main body, and the fixer main body is of a hollow structure with a cavity, and the fixer framework is embedded in the cavity of the fixer main body. The auricle orthosis has a simple structure, and can be worn comfortably by patients. The invention also discloses a preparation method of the auricle orthosis.
Description
Technical Field
The invention belongs to the technical field of medical appliances, in particular to an auricle orthosis and a preparation method thereof, and particularly relates to neonatal auricle morphological deformity correction and personalized production thereof.
Background
Auricle morphological deformity refers to abnormal changes in the morphology of the auricle that are well developed. Since the pregnancy period is 5-9 weeks of the development period of the auricular cartilage scaffold, the embryo development abnormality can cause the defects of auricular cartilage and soft tissue structures so as to generate auricular structural deformity.
The malformation of auricle is caused by the deformation of auricle bracket due to the compression of improper physical external force in uterus or after birth including the extrusion of birth canal, the malposition of fetus, the malposition of sleeping, etc. after 9 weeks of pregnancy. The auricle morphology deformity can be either surgical plastic or the auricle morphology can be remodeled by the auricle corrector. However, in the operation treatment, cartilage deformation, high recurrence rate, invasive and the like exist, and the comprehensive evaluation risk is high.
Japanese scholars Matsuo K and Hirose T et al in 1984 first proposed correction of ear morphology deformities by non-surgical treatment during neonatal period in the journal of repair reconstructive plastic surgery in the United states, but the correction method was not standardized and not popularized due to complex procedures.
Since 2010, research and application of ear molds to correct congenital ear morphology deformities are started abroad, early intervention is performed on the congenital ear morphology deformities, more than 90% of clinical effective rate is obtained, according to the comparison of ear plastic surgery data of the last 10 years in the United states, the surgery amount is reduced from 36295 cases to 29828 cases each year, the reduction rate is 18%, analysis is performed from the aspects of medical risks, medical expenses, even human health and care, and the noninvasive ear plastic technology is a breakthrough in ear soft bone mechanical correction and has important clinical value.
There are two types of prior art auricle orthoses: one is to use a fixed standard form and structure of auricle orthosis, such as the correction of a deformed ear disclosed in chinese patent publication 200880108740X, using plastic materials, but this type of orthosis is difficult to meet the non-use requirements of different auricle deformed patients.
The other is to print out the auricle orthosis by using a 3D printer, such as the neonate auricle orthosis and the manufacturing method thereof disclosed in China patent document with the application number 2017102148613, the auricle orthosis is entirely made of silica gel materials, and although the technology can solve the requirements of different patients on individuation, the technology is limited by the materials of the 3D printer, the overall strength of the auricle orthosis cannot be ensured, the wearing comfort of the patients is influenced, and therefore, the problem of the materials cannot be overcome in a short period of time.
Disclosure of Invention
One of the objects of the present invention is to provide an auricle orthosis that is simple in construction and comfortable to wear for the patient.
The above object of the present invention is achieved by the following technical scheme: an auricle orthosis, includes base and fixer, and the inboard that the auricle is close to the head is arranged in to the base, and the outside of auricle is arranged in to the fixer, and the auricle of a part centre gripping auricle of fixer, another part laminating with the base mutually, its characterized in that: the base is of a combined structure and is composed of a base main body and a base framework embedded in the base main body, the base main body is of a hollow structure with a cavity, the base framework is embedded in the cavity of the base main body, the base framework is used as a frame of the whole base and can bear external force, the fixer is of a combined structure and is composed of a fixer main body and a fixer framework embedded in the fixer main body, the fixer main body is of a hollow structure with a cavity, and the fixer framework is embedded in the cavity of the fixer main body.
In the invention, the base main body and the fixer main body are made of the same material and are made of medical silica gel for being in direct contact with the skin of auricles, the base framework and the fixer framework are made of plastic low-temperature thermoplastic materials, the base main body and the fixer main body are adaptively adjusted according to different shapes of auricles of patients, the base main body and the fixer are made of combined materials of the silica gel and the low-temperature thermoplastic materials, the strength requirement can be met, the individual difference requirement of the patients can be met, and the wearing comfort requirement of the patients can be met.
The auricle orthosis of the invention uses two combined materials of low-temperature thermoplastic materials and soft medical silica gel, successfully solves two problems of personalized customization and wearing comfort simultaneously, and can also carry out personalized customization according to various different needs of patients.
The base body of the auricle orthosis adopts medical silica gel, but is not a solid structure, but a hollow structure with an inner cavity. The low-temperature thermoplastic material is embedded in the base to serve as a frame of the whole component and can bear enough external force. Thus, the soft medical silicone material of the base is still in contact with the patient's skin, but the internal low temperature thermoplastic material is stressed throughout the structure. Thus, the two materials are combined for use, so that the comfort of the product is maintained, and the sufficient strength of the whole product is met.
The fixator at the auricle of the auricle outline is also made of a combined material, the peripheral material is soft medical silica gel, and a low-temperature thermoplastic material is embedded in the fixator to maintain sufficient strength. The low-temperature thermoplastic material has strong plasticity, and can meet the individuation difference of patients, such as individuation differences of different appearance sizes, different parts, different forms and the like. And the medical silica gel of the outermost layer can meet the requirement of wearing comfort.
The low-temperature thermoplastic material (low temperature thermoplastic material) adopted by the invention is the existing material, is a special synthetic high-molecular polyester, and is a novel medical material processed by a series of physical and chemical methods, and is used as a manufacturing material of orthopedic external fixation, orthotics and braces.
In the invention, the number of the fixing devices is one or two.
In the invention, the fixer is fixed by the medical adhesive tape after being attached to the base, so that the orthosis is fixed on the auricle of the patient.
The invention can be improved as follows: the orthosis is also provided with a fixing cover, a plurality of hollowed-out holes are formed in the fixing cover, and the fixing cover is covered on the outer cover after the fixer is attached to the base, so that the orthosis is fixed on the auricle of a patient.
The invention adopts the material with low-temperature forming characteristic as the stress part of the auricle orthosis, and completely replaces the use of metal materials in products. Preferably, the plastic low-temperature thermoplastic material can be heated by a microwave oven or hot water with the temperature of more than 80 ℃, so that the material can be soft, is very easy to shape and can bear larger external force after the temperature is reduced to normal temperature.
Furthermore, as the invention provides a product prototype for medical staff, the medical staff can use a very simple heating tool to carry out secondary processing and adjustment according to the specific situation of the site when the medical staff is installed and worn; thus, the preparation time of a large amount of materials can be saved for medical staff, and the working efficiency is greatly improved while the treatment effect is ensured.
The second object of the invention is to provide a method for manufacturing the auricle orthosis, which is simple to operate.
The above object of the present invention is achieved by the following technical scheme: the preparation method of the auricle orthosis is characterized in that the method comprises the steps of manufacturing a base and manufacturing a fixer, wherein,
The manufacturing procedure of the base comprises the following steps:
(1) Initial molding process of base
11. Forming a base main body by adopting a silica gel mold;
12. injection molding a base skeleton by adopting a low-temperature thermoplastic material;
13. Embedding a base skeleton into a base main body to obtain an initial base;
(2) Microwave oven internal heating low temperature thermoplastic forming process of base
Placing the whole initial base in a microwave oven, heating the temperature of the initial base to 80 ℃, taking out the initial base, adjusting the material into a size and a shape matched with auricle of a patient before the temperature of the initial base is reduced to 65 ℃, and hardening the low-temperature thermoplastic material after the temperature is reduced to room temperature of 25 ℃ so that the shape of the whole base is maintained and the shape of the whole base has enough strength;
the manufacturing process of the fixer comprises the following steps:
(1) Initial forming process of fixer
11. Forming a fixer main body by adopting a silica gel mold;
12. injection molding the fixer framework by adopting low-temperature thermoplastic materials;
13. Embedding a fixer framework into a fixer main body to obtain an initial fixer;
(2) Microwave oven internal heating low-temperature hot-plastic forming process of fixer
The whole initial fixer is placed in a microwave oven, the temperature of the initial fixer is heated to 80 ℃ and then taken out, before the temperature of the initial fixer is reduced to 65 ℃, the material is adjusted to be in a size and shape matched with the auricle of a patient, after the temperature is reduced to the room temperature of 25 ℃, the thermoplastic material is hardened, so that the shape of the whole fixer is maintained, and the whole fixer has enough strength.
The above object of the present invention can be achieved by the following technical scheme: the preparation method of the auricle orthosis is characterized in that the method comprises the steps of manufacturing a base and manufacturing a fixer, wherein,
The manufacturing procedure of the base comprises the following steps:
(1) Initial molding process of base
11. Forming a base main body by adopting a silica gel mold;
12. injection molding a base skeleton by adopting a low-temperature thermoplastic material;
13. Embedding a base skeleton into a base main body to obtain an initial base;
(2) Hot water heating low temperature thermoplastic forming process of base
Placing the whole initial base in hot water, heating the temperature of the initial base to 80 ℃, taking out, adjusting the material to be in a size and shape matched with auricle of a patient before the temperature of the initial base is reduced to 65 ℃, and hardening the low-temperature thermoplastic material after the temperature is reduced to room temperature of 25 ℃ so that the shape of the whole base is maintained and the base has enough strength;
the manufacturing process of the fixer comprises the following steps:
(1) Initial forming process of fixer
11. Forming a fixer main body by adopting a silica gel mold;
12. injection molding the fixer framework by adopting low-temperature thermoplastic materials;
13. Embedding a fixer framework into a fixer main body to obtain an initial fixer;
(2) Hot water heating low temperature thermoplastic forming process of fixer
The whole initial fixator is placed in hot water, the initial fixator is taken out after being heated to 80 ℃, before the temperature of the initial fixator is reduced to 65 ℃, the material is adjusted to be in a size and shape matched with the auricle of a patient, after the temperature is reduced to the room temperature of 25 ℃, the thermoplastic material is hardened, so that the shape of the whole fixator is maintained, and the whole fixator has enough strength.
Compared with the prior art, the fixer and the base of the auricle orthosis are combined structures formed by combining low-temperature thermoplastic materials and soft medical silica gel, and can simultaneously solve the two problems of personalized customization and wearing comfort of patients. The base body of the auricle orthosis adopts medical silica gel, and a low-temperature thermoplastic material is embedded in the cavity of the base and is used as a frame of the whole part and can bear enough external force. Meanwhile, the fixator of the auricle outline is also a combined material, the peripheral material is soft medical silica gel, and a low-temperature thermoplastic material is embedded in the peripheral material to maintain enough strength. The low-temperature thermoplastic material has strong plasticity, can be adjusted according to the individual specific conditions of the patient, is personalized and customized according to various different needs of the patient, meets the individual difference of the patient, and simultaneously adopts medical silica gel as the material of which the outermost layer is contacted with the auricle skin of the patient so as to meet the requirement of wearing comfort.
Drawings
The invention will now be described in further detail with reference to the drawings and to specific examples.
FIG. 1 is an overall block diagram of a first embodiment of the auricle orthosis of the present invention showing the positional relationship between the base and the anchor;
fig. 2 is a view showing a state of use of the auricle orthosis according to the first embodiment of the present invention, in which the auricle orthosis is used for auricle morphology correction;
fig. 3 is a perspective view of a base of a first embodiment of the auricle orthosis of the present invention;
Fig. 4 is an external view of the base of the first embodiment of the auricle orthosis of the present invention;
fig. 5 is a perspective view of a holder of a first embodiment of the auricle orthosis of the present invention;
fig. 6 is an external view of the holder of the first embodiment of the auricle orthosis of the present invention;
fig. 7 is a view showing a state of use of the auricle orthosis according to the second embodiment of the present invention, in which the auricle orthosis is used for auricle morphology correction.
Reference numerals illustrate:
1-a base, 11-a base skeleton, 12-a base main body,
2-Fixer, 21-fixer framework, 22-fixer main body.
Detailed Description
Example 1
As shown in fig. 1 to 6, the auricle orthosis according to the embodiment of the present invention includes a base 1 and a holder 2, the base 1 is disposed on the inner side of the auricle near the head, the holder 2 is disposed on the outer side of the auricle, a part of the holder 2 holds the auricle, the other part is attached to the base 1, the base 1 is a combined structure composed of a base body 12 and a base skeleton 11 embedded in the base body 12, the base body 12 is a hollow structure having a cavity, the base skeleton 11 is embedded in the cavity of the base body 12, the base skeleton 11 is a frame of the whole base and can bear external force, the holder 2 is also a combined structure composed of a holder body 22 and a holder skeleton 21 embedded in the holder body 22, and the holder body 22 is a hollow structure having a cavity, and the holder skeleton 21 is embedded in the cavity of the holder body 22.
In this embodiment, the materials of the base main body 12 and the fixer main body 22 are the same, and are both medical silica gel, and are used for directly contacting with the skin of the auricle, the materials of the base skeleton 11 and the fixer skeleton 21 are the same, and are both plastic low-temperature thermoplastic materials, which can soften when heated to a certain temperature, and have good plasticity and hardness after being cooled to room temperature, the adopted low-temperature thermoplastic materials can be adaptively adjusted according to different shapes of the auricle of a patient, so as to meet the individual difference requirements of the patient, and the base 1 and the fixer 2 are both made of combined materials of the silica gel and the low-temperature thermoplastic materials, so that the strength requirements can be met, and the individual difference requirements of the patient can be met, and the comfort requirements of wearing of the patient can also be met.
In this embodiment, the orthosis is secured to the auricle of the patient by means of a medical adhesive tape after the anchor 2 has been applied to the base 1 in use. The auricle orthosis is suitable for correcting various auricle morphological deformities, and is especially suitable for correcting auricle morphological deformities of newborns.
As an improvement of the embodiment, the orthosis is also provided with a fixing cover, a plurality of hollowed holes are formed in the fixing cover, and the fixing cover is covered after the fixator 2 is attached to the base 1, so that the orthosis is fixed on the auricle of a patient.
The preparation method of the auricle orthosis adopts a low-temperature thermal plastic material shaping method heated in a microwave oven, and concretely comprises a base manufacturing procedure and a fixer manufacturing procedure, wherein,
The manufacturing procedure of the base comprises the following steps:
(1) Initial molding process of base
11. Forming a base main body by adopting a silica gel mold;
12. injection molding a base skeleton by adopting a low-temperature thermoplastic material;
13. Embedding a base skeleton into a base main body to obtain an initial base;
(2) Microwave oven internal heating low temperature thermoplastic forming process of base
Placing the whole initial base in a microwave oven, heating the temperature of the initial base to 80 ℃, taking out the initial base, adjusting the material into a size and a shape matched with auricle of a patient before the temperature of the initial base is reduced to 65 ℃, and hardening the low-temperature thermoplastic material after the temperature is reduced to room temperature of 25 ℃ so that the shape of the whole base is maintained and the shape of the whole base has enough strength;
the manufacturing process of the fixer comprises the following steps:
(1) Initial forming process of fixer
11. Forming a fixer main body by adopting a silica gel mold;
12. injection molding the fixer framework by adopting low-temperature thermoplastic materials;
13. Embedding a fixer framework into a fixer main body to obtain an initial fixer;
(2) Microwave oven internal heating low-temperature hot-plastic forming process of fixer
The whole initial fixer is placed in a microwave oven, the temperature of the initial fixer is heated to 80 ℃ and then taken out, before the temperature of the initial fixer is reduced to 65 ℃, the material is adjusted to be in a size and shape matched with the auricle of a patient, after the temperature is reduced to the room temperature of 25 ℃, the thermoplastic material is hardened, so that the shape of the whole fixer is maintained, and the whole fixer has enough strength.
The method can finely adjust the shape of the auricle outline fixator according to the actual condition of the patient according to the position and the severity of the patient.
The preparation method of the auricle orthosis can also adopt a hot water heating low temperature thermoplastic material shaping method, and concretely comprises a base manufacturing procedure and a fixer manufacturing procedure, wherein,
The manufacturing procedure of the base comprises the following steps:
(1) Initial molding process of base
11. Forming a base main body by adopting a silica gel mold;
12. injection molding a base skeleton by adopting a low-temperature thermoplastic material;
13. Embedding a base skeleton into a base main body to obtain an initial base;
(2) Hot water heating low temperature thermoplastic forming process of base
Placing the whole initial base in hot water, heating the temperature of the initial base to 80 ℃, taking out, adjusting the material to be in a size and shape matched with auricle of a patient before the temperature of the initial base is reduced to 65 ℃, and hardening the low-temperature thermoplastic material after the temperature is reduced to room temperature of 25 ℃ so that the shape of the whole base is maintained and the base has enough strength;
the manufacturing process of the fixer comprises the following steps:
(1) Initial forming process of fixer
11. Forming a fixer main body by adopting a silica gel mold;
12. injection molding the fixer framework by adopting low-temperature thermoplastic materials;
13. Embedding a fixer framework into a fixer main body to obtain an initial fixer;
(2) Hot water heating low temperature thermoplastic forming process of fixer
The whole initial fixator is placed in hot water, the initial fixator is taken out after being heated to 80 ℃, before the temperature of the initial fixator is reduced to 65 ℃, the material is adjusted to be in a size and shape matched with the auricle of a patient, after the temperature is reduced to the room temperature of 25 ℃, the thermoplastic material is hardened, so that the shape of the whole fixator is maintained, and the whole fixator has enough strength.
The method can finely adjust the shape of the auricle outline fixator according to the actual condition of the patient according to the position and the severity of the patient.
Example two
A second embodiment of the auricle orthosis according to the invention is shown in fig. 7, which differs from the first embodiment in that it comprises a base 1 and two holders 2, the two holders 2 having different profile radii, which meet the actual requirements of adjustment. The two holders 2 can also use the same contour radius.
The above-mentioned embodiments of the present invention are not intended to limit the scope of the present invention, and the embodiments of the present invention are not limited thereto, and all kinds of modifications, substitutions or alterations made to the above-mentioned structures of the present invention according to the above-mentioned general knowledge and conventional means of the art without departing from the basic technical ideas of the present invention shall fall within the scope of the present invention.
Claims (8)
1. The auricle orthosis comprises a base and a fixer, wherein the base is arranged on the inner side of the auricle close to the head, the fixer is arranged on the outer side of the auricle, one part of the fixer clamps the auricle, the other part of the fixer is attached to the base, the base is of a combined structure and consists of a base main body and a base framework embedded in the base main body, the base main body is of a hollow structure with a cavity, the base framework is embedded in the cavity of the base main body, the base framework serves as a framework of the whole base and can bear external force, the fixer is of a combined structure and consists of a fixer main body and a fixer framework embedded in the fixer main body, the fixer main body is of a hollow structure with a cavity, and the fixer framework is embedded in the cavity of the fixer main body; the base main part is the same with the material of fixer main part, is medical silica gel for with the skin direct contact of auricle, the material of base skeleton and fixer skeleton is the same, is the plastic low temperature thermoplastic material, adopts low temperature thermoplastic material to carry out adaptability adjustment according to patient's auricle's different shape, satisfies patient's individuation difference requirement, base and fixer all adopt silica gel and the combined material of low temperature thermoplastic material, can satisfy the intensity requirement, also can satisfy patient's individuation difference requirement, can also satisfy patient's comfort requirement of wearing, its characterized in that: the method comprises a base manufacturing process and a fixer manufacturing process, wherein,
The manufacturing procedure of the base comprises the following steps:
(1) Initial molding process of base
11. Forming a base main body by adopting a silica gel mold;
12. injection molding a base skeleton by adopting a low-temperature thermoplastic material;
13. Embedding a base skeleton into a base main body to obtain an initial base;
(2) Microwave oven internal heating low temperature thermoplastic forming process of base
Placing the whole initial base in a microwave oven, heating the temperature of the initial base to 80 ℃, taking out the initial base, adjusting the material into a size and a shape matched with auricle of a patient before the temperature of the initial base is reduced to 65 ℃, and hardening the low-temperature thermoplastic material after the temperature is reduced to room temperature of 25 ℃ so that the shape of the whole base is maintained and the shape of the whole base has enough strength;
the manufacturing process of the fixer comprises the following steps:
(1) Initial forming process of fixer
11. Forming a fixer main body by adopting a silica gel mold;
12. injection molding the fixer framework by adopting low-temperature thermoplastic materials;
13. Embedding a fixer framework into a fixer main body to obtain an initial fixer;
(2) Microwave oven internal heating low-temperature hot-plastic forming process of fixer
The whole initial fixer is placed in a microwave oven, the temperature of the initial fixer is heated to 80 ℃ and then taken out, before the temperature of the initial fixer is reduced to 65 ℃, the material is adjusted to be in a size and shape matched with the auricle of a patient, after the temperature is reduced to the room temperature of 25 ℃, the thermoplastic material is hardened, so that the shape of the whole fixer is maintained, and the whole fixer has enough strength.
2. The method of manufacturing according to claim 1, characterized in that: the number of the fixtures is one or two.
3. The production method according to any one of claims 1 to 2, characterized in that: the fixing device is fixed through a medical adhesive tape after being attached to the base, so that the orthosis is fixed on the auricle of the patient.
4. The production method according to any one of claims 1 to 2, characterized in that: the orthosis is also provided with a fixing cover, a plurality of hollowed-out holes are formed in the fixing cover, and the fixing cover is covered on the outer cover after the fixer is attached to the base, so that the orthosis is fixed on the auricle of a patient.
5. The auricle orthosis comprises a base and a fixer, wherein the base is arranged on the inner side of the auricle close to the head, the fixer is arranged on the outer side of the auricle, one part of the fixer clamps the auricle, the other part of the fixer is attached to the base, the base is of a combined structure and consists of a base main body and a base framework embedded in the base main body, the base main body is of a hollow structure with a cavity, the base framework is embedded in the cavity of the base main body, the base framework serves as a framework of the whole base and can bear external force, the fixer is of a combined structure and consists of a fixer main body and a fixer framework embedded in the fixer main body, the fixer main body is of a hollow structure with a cavity, and the fixer framework is embedded in the cavity of the fixer main body; the base main part is the same with the material of fixer main part, is medical silica gel for with the skin direct contact of auricle, the material of base skeleton and fixer skeleton is the same, is the plastic low temperature thermoplastic material, adopts low temperature thermoplastic material to carry out adaptability adjustment according to patient's auricle's different shape, satisfies patient's individuation difference requirement, base and fixer all adopt silica gel and the combined material of low temperature thermoplastic material, can satisfy the intensity requirement, also can satisfy patient's individuation difference requirement, can also satisfy patient's comfort requirement of wearing, its characterized in that: the method comprises a base manufacturing process and a fixer manufacturing process, wherein,
The manufacturing procedure of the base comprises the following steps:
(1) Initial molding process of base
11. Forming a base main body by adopting a silica gel mold;
12. injection molding a base skeleton by adopting a low-temperature thermoplastic material;
13. Embedding a base skeleton into a base main body to obtain an initial base;
(2) Hot water heating low temperature thermoplastic forming process of base
Placing the whole initial base in hot water, heating the temperature of the initial base to 80 ℃, taking out, adjusting the material to be in a size and shape matched with auricle of a patient before the temperature of the initial base is reduced to 65 ℃, and hardening the low-temperature thermoplastic material after the temperature is reduced to room temperature of 25 ℃ so that the shape of the whole base is maintained and the base has enough strength;
the manufacturing process of the fixer comprises the following steps:
(1) Initial forming process of fixer
11. Forming a fixer main body by adopting a silica gel mold;
12. injection molding the fixer framework by adopting low-temperature thermoplastic materials;
13. Embedding a fixer framework into a fixer main body to obtain an initial fixer;
(2) Hot water heating low temperature thermoplastic forming process of fixer
The whole initial fixator is placed in hot water, the initial fixator is taken out after being heated to 80 ℃, before the temperature of the initial fixator is reduced to 65 ℃, the material is adjusted to be in a size and shape matched with the auricle of a patient, after the temperature is reduced to the room temperature of 25 ℃, the thermoplastic material is hardened, so that the shape of the whole fixator is maintained, and the whole fixator has enough strength.
6. The method of manufacturing according to claim 5, wherein: the number of the fixtures is one or two.
7. The production method according to any one of claims 5 to 6, characterized in that: the fixing device is fixed through a medical adhesive tape after being attached to the base, so that the orthosis is fixed on the auricle of the patient.
8. The production method according to any one of claims 5 to 6, characterized in that: the orthosis is also provided with a fixing cover, a plurality of hollowed-out holes are formed in the fixing cover, and the fixing cover is covered on the outer cover after the fixer is attached to the base, so that the orthosis is fixed on the auricle of a patient.
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| CN113057778A (en) * | 2020-01-02 | 2021-07-02 | 广州迪克医疗器械有限公司 | Ear wheel former and adjustable ear shaping mechanism |
| CN111067684A (en) * | 2020-03-04 | 2020-04-28 | 林向上 | Auricle shape orthosis and preparation method thereof |
| CN116059027A (en) * | 2021-11-01 | 2023-05-05 | 中国石油化工股份有限公司 | Auricle orthosis and its preparation method and use method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103284825A (en) * | 2012-02-22 | 2013-09-11 | 中国医学科学院整形外科医院 | Non-surgical auricle malformation orthosis |
| CN206499555U (en) * | 2016-08-23 | 2017-09-19 | 闫承碧 | A kind of ear's KAFO |
| CN208625936U (en) * | 2018-01-25 | 2019-03-22 | 中山大学孙逸仙纪念医院 | auricular orthosis |
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| JP3842844B2 (en) * | 1996-07-02 | 2006-11-08 | 財団法人脳科学・ライフテクノロジー研究所 | Correction tool for the treatment of abnormal morphologies of the pinna |
| DE69833202T2 (en) * | 1998-08-12 | 2006-11-02 | Michael Miravet Sorribes | INSTRUMENT TO CORRECT THE FORM OF THE OUTER EAR |
| KR101173887B1 (en) * | 2010-02-01 | 2012-08-14 | 이승용 | Earflap brace |
| WO2012028995A1 (en) * | 2010-08-30 | 2012-03-08 | Koninklijke Philips Electronics N.V. | Patient interface device with a frame assembly having a double-y supporting structure |
| MX363888B (en) * | 2011-10-08 | 2019-04-05 | Frances Riley Mary | Facial structure stabilization methods and apparatus. |
| CN206102794U (en) * | 2016-07-21 | 2017-04-19 | 周粤闽 | Child deformity of external ear unscrambler |
| CN206372169U (en) * | 2016-08-31 | 2017-08-04 | 陈筱 | A kind of spinal distractor support frame |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103284825A (en) * | 2012-02-22 | 2013-09-11 | 中国医学科学院整形外科医院 | Non-surgical auricle malformation orthosis |
| CN206499555U (en) * | 2016-08-23 | 2017-09-19 | 闫承碧 | A kind of ear's KAFO |
| CN208625936U (en) * | 2018-01-25 | 2019-03-22 | 中山大学孙逸仙纪念医院 | auricular orthosis |
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