CN114533363A - Postoperation auricle shaping device and preparation method thereof - Google Patents
Postoperation auricle shaping device and preparation method thereof Download PDFInfo
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- CN114533363A CN114533363A CN202210290805.9A CN202210290805A CN114533363A CN 114533363 A CN114533363 A CN 114533363A CN 202210290805 A CN202210290805 A CN 202210290805A CN 114533363 A CN114533363 A CN 114533363A
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- 210000000624 ear auricle Anatomy 0.000 claims description 18
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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. splints, casts or braces
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C69/00—Combinations of shaping techniques not provided for in a single one of main groups B29C39/00 - B29C67/00, e.g. associations of moulding and joining techniques; Apparatus therefore
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Nursing (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Biomedical Technology (AREA)
- Mechanical Engineering (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention provides a postoperation auricle shaping device and a preparation method thereof, the device comprises a customization component, the customization component comprises an air bag and an inflatable structure, the air bag is customized according to the shape of an auricle, the inflatable structure comprises an inflatable shell, a pressing piece is arranged on one side of the inflatable shell in an opening and sealed mode corresponding to the opening, a first channel is arranged on the pressing piece, a first air valve is arranged on the first channel, the pressing piece is connected with the inner side of the inflatable shell through an elastic structure, the inflatable shell is connected with the air bag, a second channel is arranged between the inflatable shell and the air bag, a second air valve is arranged on the second channel and connected with a connecting rod, and the connecting rod penetrates through the air bag in a sealed mode and is arranged in the inflatable shell. The invention has the main functions of fixing the shape of the reconstructed auricle and preventing the situations of scar contracture, scar deformation and the like.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to a postoperation auricle shaping device and a preparation method thereof.
Background
The small ear deformity is one of the most important birth defects of the face, the domestic incidence rate is 1/3000, the occurrence mechanism is not completely clear at present, and the small ear deformity can be related to abnormal development of cells of the first and second gills or neural crest in the embryonic period. The small ear deformity mostly presents in the external ear pinna structure, which affects the beauty, serious people can have the occlusion and stenosis of the external auditory canal, the middle ear deformity and the like, which affect the hearing and have serious influence on the physical and psychological health of patients.
At present, auricle reconstruction surgery is mostly adopted to clinically treat the small ear deformity to restore the appearance of the auricle, the treatment effect is obvious, but the incidence rate of postoperative complications is high. At present, the external ear reconstruction method by skin soft tissue dilatation is still one of the most main external ear reconstruction methods in China. The postoperative complications comprise hematoma, infection, flap ischemic necrosis, bracket cartilage exposure and the like. This requires active post-operative infection resistance, hemostasis and observation of flap blood flow.
The final purpose after auricle reconstruction is to restore the auricle form, and partial detailed anatomical structures of reconstructed auricle forms are not satisfied due to scar contracture of partial patients after the operation. And the existing medical level and market fail to present products meeting the technology.
Disclosure of Invention
The technical problem to be solved by the invention is to overcome the defects in the prior art and provide a post-operation auricle shaping device and a preparation method thereof, which can adjust and pressurize, fix the post-operation auricle shape, guide the post-operation auricle shape to grow towards a more beautiful direction and prevent secondary damage to the body and the mind caused by contracture deformation.
In order to solve the technical problems, the invention adopts the following technical scheme:
according to a first technical scheme of the invention, the postoperation auricle shaping device comprises a customization component, the customization component comprises an air bag and an inflation structure, the air bag is customized according to the shape of an auricle, the inflation structure comprises an inflation shell, a pressing piece is arranged on one side of the inflation shell in an opening and is hermetically arranged corresponding to the opening, a first channel is arranged on the pressing piece, a first air valve is arranged on the first channel, the pressing piece is connected with the inner side of the inflation shell through an elastic structure, the inflation shell is connected with the air bag, a second channel is arranged between the inflation shell and the air bag, a second air valve is arranged on the second channel, the second air valve is connected with a connecting rod, and the connecting rod hermetically penetrates through the air bag and the inflation shell and is arranged in the inflation shell.
As a preferred technical solution, the device further comprises a standard component, the standard component is used for installing the customized component, the standard component comprises a housing, the housing is symmetrically provided with installation holes relative to the center of the housing, the customized component is installed on the housing through the installation holes and matching with an air pressure adjusting panel, and at least one air pressure transmission port is arranged corresponding to the inflatable shell.
Preferably, the elastic structure is a spring, and the two springs are symmetrically arranged about the inflatable shell.
Preferably, the air pressure transmission opening is a gap between the mounting hole and the air pressure adjustment panel.
Preferably, the air pressure transfer port is formed by forming a through hole in the air pressure adjustment panel.
Preferably, the pressing member is a pressing structure panel having elasticity.
According to a first aspect of the present invention, there is provided a method of manufacturing a post-operative pinna shaping device according to any one of the first aspects of the present invention, the method comprising: scanning a normal ear auricle or a standard auricle model of a patient, and collecting complete auricle data; carrying out reverse modeling design processing on the auricle data to obtain a complete auricle model; mirroring the complete auricle model, and designing a mould into a blow molding manufacturing process mould; preparing and molding by using an SLA mode and according to the blow molding manufacturing process mold through 3D printing; preparing and molding the air bag by using a PP film material in a blow molding manufacturing mode; based on the thickness and the size of predetermined inflatable housing, utilize the flexible glue material to print the shaping through the DLP mode or print through the SLA mode and obtain the air chamber mould, reuse silica gel material carries out the duplication of patterns and obtains inflatable housing adopts MJF or SLS mode to use nylon PA12 material to print the preparation and obtains inflatable component, inflatable component includes first pneumatic valve, second pneumatic valve and connecting rod, will inflatable component, pressing member and behind the inflatable housing equipment shaping, carry out the adhesion through adhesive and gasbag, obtain postoperative auricle setting device.
Compared with the prior art, the invention has the beneficial effects that:
the invention solves the problem that no related shaper is available in the market at present to avoid and solve the risk of the operation sequelae. The invention has the main functions of fixing the shape of the reconstructed auricle and preventing the situations of atrophy, deformation and the like. The invention has certain aesthetic property, and improves the acceptance of patients on the invention under the condition of ensuring the functionality. The invention adopts novel light materials, such as nylon, carbon fiber and the like, reduces the burden of wearing and using of a patient under the condition of ensuring functionality, and prevents secondary damage in the using process.
Drawings
In order to more clearly illustrate the detailed description of the invention or the technical solutions in the prior art, the drawings that are needed in the detailed description of the invention or the prior art will be briefly described below. Throughout the drawings, like elements or portions are generally identified by like reference numerals. In the drawings, elements or portions are not necessarily drawn to scale.
Fig. 1 shows a cross-sectional view of a post-operative pinna shaping device in accordance with an embodiment of the present invention;
fig. 2 illustrates a perspective view of a balloon of a post-operative auricle shaping device according to an embodiment of the present invention;
fig. 3 illustrates a perspective view of a post-operative auricle shaping device according to an embodiment of the present invention;
fig. 4 shows a perspective view of a post-operative auricle shaping device according to an embodiment of the present invention;
FIG. 5 shows a flow chart of a method for preparing a postsurgical pinnate shaping device according to an embodiment of the present invention and
fig. 6 is a perspective sectional view showing a balloon of a postsurgical auricle shaping apparatus according to an embodiment of the present invention.
Detailed Description
The technical solutions in the embodiments of the present invention will be described clearly and completely below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It should be noted that all the directional indicators (such as upper, lower, left, right, front and rear … …) in the embodiment of the present invention are only used to explain the relative position relationship between the components, the movement situation, etc. in a specific posture (as shown in the drawing), and if the specific posture is changed, the directional indicator is changed accordingly.
In addition, the descriptions related to "first", "second", etc. in the present invention are only for descriptive purposes and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.
The invention will now be further described with reference to the accompanying drawings.
Fig. 1 shows a cross-sectional view of a post-operative auricle shaping device according to an embodiment of the present invention. An embodiment of the present invention provides a post-operative auricle shaping device, as shown in fig. 1, which includes a customization component, the customized component comprises an air bag 1 and an inflating structure, the air bag 1 is customized according to the shape of an auricle, the inflatable structure comprises an inflatable shell 2, one side of the inflatable shell 2 is provided with an opening and a pressing piece 3 is arranged corresponding to the opening in a sealing way, a first channel 4 is arranged on the pressing piece 3, a first air valve 5 is arranged on the first channel 4, the pressing piece 3 is connected with the inner side of the inflatable shell 2 through an elastic structure 6, the inflatable shell 2 is connected with the air bag 1, a second channel 7 is arranged between the inflatable shell 2 and the air bag 1, a second air valve 8 is arranged on the second channel 7, the second gas valve 8 is connected to a connecting rod 9, and the connecting rod 9 is hermetically arranged in the inflation housing 2 through the gas bag 1 and the inflation housing 2.
When the postoperative auricle shaping device provided by the embodiment of the invention is used specifically, the pressure of the air bag 1 is adjusted by continuously pressing the inflatable structure and the long-pressing air release structure, so that the auricle is pressed at a proper pressure, the shaping effect is ensured, and the auricle avascular necrosis caused by overlarge pressure is avoided. The regulation of the pressure of the airbag 1 includes an inflation process and a deflation process.
The inflation process is as follows: as shown in fig. 1, the pressing point A or the middle position of the pressing point A, B on the pressing piece 3 is pressed, the pressing degree does not exceed the position where the connecting rod 9 can be touched, the first air valve 5 is kept in a closed state under the air pressure, the second air valve 8 is opened, and air in an inflating structure enters the air bag 1, so that the air bag 1 is inflated and attached to the auricle to achieve the orthopedic effect. When the pressing is released, the pressing piece 3 is restored to the initial position under the action of the elastic structure 6, at the moment, the second air valve 8 is closed under the action of air pressure, the shape of the air bag 1 is kept fixed, the first air valve 5 is opened under the action of the air pressure, and the outside air enters the inflation structure to supplement the inside air.
The above process is a complete inflation process. When the patient is uncomfortable to the ear due to over inflation or when the postoperative auricle shaping device needs to be deflated, the method is realized by the following steps: as shown in fig. 1, the pressing point B on the pressing member 3 is pressed for a long time to make the structure at the pressing point B touch the connecting rod 9, one end of the connecting rod 9 is connected with the second air valve 8, the second air valve 8 is opened after the connecting rod 9 touches, and the air bag 1 is deflated to realize deflation.
In some embodiments, as shown in FIG. 1, the resilient structure 6 is a spring, and the two springs are arranged symmetrically about the inflatable housing 2. The resilient structure 6 described herein is specifically a structure having a resilient force, including but not limited to a spring. For example, it may be a resilient structure of rubber material, or the like.
In some embodiments, the press 3 is a press structural panel having elasticity.
In the embodiment of the present invention, the specific shape of the airbag 1 is customized according to the shape of the auricle. For example, fig. 2 shows a perspective view of a balloon of a post-operative pinna shaping device in accordance with an embodiment of the present invention. As shown in fig. 2, the airbag 1 is mostly in this shape, but the auricle of each person is different. Therefore, the air bag can be customized by 3D scanning the complete auricle shape (normal auricle shape or standard auricle shape) under the conditions of complete skin, no red swelling, no suppuration and no ischemia after the auricle reconstruction operation. The customized air bag can be perfectly matched with the ears of a patient, the shape of the reconstructed auricle is well fixed, the phenomena of atrophy, deformation and the like are prevented, and the customized air bag has certain aesthetic property.
Fig. 3 is a perspective view showing a postsurgical auricle shaping apparatus according to an embodiment of the present invention, the apparatus further includes a standard component 10, the standard component 10 is used for mounting the customized component, the standard component 10 includes a housing 10-1, mounting holes 10-2 are symmetrically formed on the housing 10-1 with respect to the center of the housing, the customized component is mounted on the housing 10-1 through the mounting holes 10-2 in cooperation with an air pressure adjusting panel 10-3, and at least one air pressure transmission port 10-4 is formed corresponding to the air-filled housing 2.
The size of the standard cell 10 may be selected specifically for the patient's head type. The standard component 10 may be made of a flexible or resilient material that serves to mount the customized component and further cooperate with the customized component being secured to the ear of the patient. The air pressure adjusting panel 10-3 is movably arranged on the shell 1. With reference to the pressing point a and the pressing point B shown in fig. 1, two convex points may be correspondingly disposed on the air pressure adjustment panel 10-3, so as to facilitate the operation of the patient or the medical staff to adjust the pressure of the air bag 1.
In some embodiments, as shown in fig. 3, the air pressure transmission opening 10-4 is a gap between the mounting hole 10-2 and the air pressure adjustment panel 10-3.
In some embodiments, as shown in fig. 4, the air pressure transfer port 10-4 is formed by forming a through hole in the air pressure adjustment panel 10-3.
Fig. 5 shows a flowchart of a method of preparing a post-operative pinna shaping device in accordance with an embodiment of the present invention. The embodiment of the invention provides a preparation method of a postoperation auricle shaping device. The method starts with step S100, scanning the normal ear pinna or the standard pinna model of the patient, and collecting complete pinna data. It should be noted that the standard auricle model is a model commonly used in medical teaching or demonstration, and is suitable for auricles of most of ordinary people. The complete pinna data may specifically be a three-dimensional volumetric model formed by scanning.
In step S200, the auricle data is subjected to reverse modeling design processing to obtain a complete auricle model. For example only, the step may input the pinna data into a geogenic Design X software for reverse modeling Design processing, so as to obtain a complete pinna model. The Geomagic Design X software is a CAD model engineering software. It is understood that, persons skilled in the art may also use other three-dimensional reverse engineering software to implement step S200, and the selection of the software in the embodiment of the present invention is only an example and is not limited.
In step S300, the complete pinna model is mirrored and the mold is designed as a blow molding process mold. In case of a scanned standard pinna model, it can also be mirrored.
In step S400, a molding is prepared by 3D printing using the SLA method and according to the blow molding fabrication process mold. The SLA method is characterized in that liquid photosensitive resin is irradiated by ultraviolet rays to be cured, a platform can sink into a resin tank layer by layer in the processing process, the resin tank is filled with liquid resin, the ultraviolet rays are irradiated on a liquid surface under the action of a deflection vibrating mirror and scan according to cross section profile information, irradiated liquid can be cured at the position where a light spot passes, a layer corresponding to a layered plane pattern is processed by one-time plane scanning and is firmly bonded with a cured part of the previous layer, and the process is repeated until the whole workpiece is finished.
In step S500, the airbag is prepared and molded by means of blow molding using PP film material. The airbag structure prepared in step S500 is shown with reference to fig. 6.
In step S600, based on the thickness and size of the preset inflatable shell, the soft rubber material is used for printing and forming in a DLP mode or printing in an SLA mode to obtain an air chamber mold, then the silica gel material is used for performing re-molding to obtain the inflatable shell, the nylon PA12 material is used for printing and manufacturing in an MJF or SLS mode to obtain the inflatable component, and the inflatable component comprises a first air valve, a second air valve and a connecting rod. The DLP mode described herein specifically means that the digital light source projects layer by layer on the surface of the liquid photosensitive resin in the form of surface light, and the layer is cured and molded layer by layer. Step S600 is for preparing an inflatable structure, which mainly includes an inflatable housing and an inflatable member. It should be noted that the thickness and size of the inflatable component of the inflatable shell are designed according to the head shape and auricle condition of the patient in an oriented mode, the pressing piece is a universal component and is not customized independently, and the opening of the inflatable shell can be closed in a matched mode according to the actual size of the inflatable shell.
Finally, in step S700, after the inflation component, the pressing component and the inflation housing are assembled and molded, the post-operation auricle shaping device is obtained by adhering the adhesive and the air bag, and the post-operation auricle shaping device can be obtained as shown in fig. 2.
The above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; such modifications and substitutions do not depart from the spirit and scope of the present invention, and they should be construed as being included in the following claims and description.
Claims (7)
1. The utility model provides a postoperative auricle setting device, a serial communication port, the device is including the customization subassembly, the customization subassembly includes gasbag and inflatable structure, the gasbag forms according to the customization of auricle shape, inflatable structure is including aerifing the casing, it corresponds to aerify one side opening of casing the sealed pressing part that is provided with of opening, set up first passageway on the pressing part, be equipped with first pneumatic valve on the first passageway, the pressing part passes through elastic construction and connects aerify the inboard of casing, aerify the casing with the gasbag is connected, and aerify the casing with set up the second passageway between the gasbag, be equipped with the second pneumatic valve on the second passageway, the connecting rod is connected to the second pneumatic valve, the connecting rod passes sealedly the gasbag and aerify the casing setting and be in aerify the casing.
2. The post-operative pinna shaping device of claim 1 further comprising a standard component for mounting the custom component, the standard component comprising a housing having mounting holes symmetrically disposed about a center of the housing, the custom component being mounted to the housing through the mounting holes and cooperating with an air pressure adjustment panel, at least one air pressure delivery opening being disposed in correspondence with the inflatable housing.
3. The post-operative pinna shaping device of claim 1 wherein the resilient structure is a spring, and the two springs are symmetrically disposed about the inflatable housing.
4. The post-operative auricle shaping device as set forth in claim 2, wherein the air pressure transmission port is a gap between the mounting hole and the air pressure-adjusting panel.
5. The post-operative auricle shaping device according to claim 2, wherein the air pressure transmitting port is formed by forming a through hole in the air pressure adjusting panel.
6. The post-operative auricle shaping device according to claim 1, wherein the pressing member is a pressing structure panel having elasticity.
7. The method of making a post-operative pinna shaping device of any one of claims 1 to 6 wherein the method of making comprises:
scanning a normal ear auricle or a standard auricle model of a patient, and collecting complete auricle data;
carrying out reverse modeling design processing on the auricle data to obtain a complete auricle model;
mirroring the complete auricle model, and designing a mould into a blow molding manufacturing process mould;
preparing and molding by using an SLA mode and according to the blow molding manufacturing process mold through 3D printing;
preparing and molding the air bag by using a PP film material in a blow molding manufacturing mode;
based on the preset thickness and size of the inflatable shell, printing and molding by using a soft rubber material in a DLP (digital light processing) mode or printing in an SLA (SLA) mode to obtain an air chamber mold, performing secondary molding by using a silica gel material to obtain the inflatable shell, and performing printing and manufacturing by using a nylon PA12 material in an MJF (MJF) or SLS mode to obtain an inflatable part, wherein the inflatable part comprises a first air valve, a second air valve and a connecting rod;
and after the inflation component, the pressing piece and the inflation shell are assembled and molded, the post-operation auricle shaping device is obtained by adhering the inflation component, the pressing piece and the inflation shell through an adhesive and an air bag.
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US20120124719A1 (en) * | 2010-11-24 | 2012-05-24 | Michlitsch Kenneth J | Methods and apparatus for ear protection |
CN106821569A (en) * | 2017-04-01 | 2017-06-13 | 南方医科大学 | Neonate's auricle KAFO and its manufacture method |
CN208447924U (en) * | 2017-09-12 | 2019-02-01 | 自贡市第四人民医院 | A kind of novel auricle pressurizing device |
CN207928408U (en) * | 2017-12-18 | 2018-10-02 | 庞冲 | Adjustable auricle orthoses |
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CN211409696U (en) * | 2019-11-28 | 2020-09-04 | 中国人民解放军联勤保障部队第九二〇医院 | Auricle protection device for ear injury person |
CN213047666U (en) * | 2020-06-11 | 2021-04-27 | 重庆医科大学附属永川医院 | Auricle orthosis capable of preventing pressure injury |
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