KR20230168594A - Patient-customized neonatal ear orthoses and methods of manufacturing the same - Google Patents

Abstract

Obtaining 3D modeled data by scanning the deformed ear shape of a newborn that needs correction; Extracting the 3D modeled data into 3D data; Modeling the shape of the orthodontic ear based on the three-dimensional data; designing a corrective device based on the modeling; and manufacturing the designed correction device using a 3D printer, wherein the step of designing the correction device based on the modeling is to design it in a shape that does not block the ear hole. A method of manufacturing a patient-customized neonatal ear correction device and A patient-customized neonatal ear correction device manufactured by the above manufacturing method is provided.

Description

Patient-customized neonatal ear orthoses and methods of manufacturing the same}

This disclosure relates to a patient-tailored neonatal ear correction device and its manufacturing method.

The ear is divided into the external ear, middle ear, and internal ear. The auricle is a general term for the outer part of the ear made of cartilage and skin. do.

Congenital ear (auricular) deformities may be the result of a specific tissue missing or misshapen, or a congenital syndrome. These malformations appear due to errors during embryonic development and can appear externally.

Deformities can be caused by physical external pressure within the uterus or as the child comes out of the uterus, and can occur due to interference with the normal shape or direction of the ear muscles due to improper pinching. Anatomically, auricular dysmorphisms can be generally classified into skin malformations and skin cartilage malformations.

In newborns, congenital auricular deformity is estimated to be approximately 20%, excluding patients with microtia, and is a very frequent deformity. Ear deformities occur in the form of cup ears, lid ears, lop ears, Stahl's ears, bat ears, etc., and the forms of deformities appear in a very diverse range. there is.

However, to date, ear correction devices have been developed focusing only on the function of correcting or molding deformed ears into the same shape as normal ears. Although they have contributed greatly to transforming deformed ears into normal ears, they have rather focused on correcting the ear shape. As a result, problems with the original function of the ear occur after ear correction. In particular, in the case of newborns, ear reconstruction is often performed by inserting an ear correction device immediately after birth. However, there may be cases where the ear is injured during the reconstruction, and even if the ear correction device is simply worn without ear reconstruction, the shape of the ear is good. Although it may be correctable, the correction device may block the ear canal, causing a new problem that reduces the original function of the ear, that is, hearing, which did not have a problem at the time of birth.

In addition, most conventional ear correction devices use ready-made ear correction devices, but the types of ear deformities vary greatly from patient to patient, and considering ear wrinkles, etc., using a ready-made ear correction device may not result in proper ear correction. In addition, pain occurs while wearing the braces, and inflammatory reactions occur during this process, which often causes problems in areas that were not problematic at the time of birth.

One embodiment is to provide a method of manufacturing a newborn ear correction device that can completely correct a deformed ear to the shape of a normal ear without deteriorating the original functions of the ear, such as the newborn's hearing.

One embodiment is to provide a method of manufacturing a patient-customized newborn ear correction device tailored to the ear shapes of newborns with various types of ear deformities.

Another embodiment is to provide a patient-customized newborn ear correction device manufactured by the patient-customized newborn ear correction device manufacturing method.

One embodiment includes acquiring 3D modeled data by scanning the shape of a newborn's deformed ear that needs correction; Extracting the 3D modeled data into 3D data; Modeling the shape of the orthodontic ear based on the three-dimensional data; designing a corrective device based on the modeling; and manufacturing the designed correction device using a 3D printer, wherein the step of designing the correction device based on the modeling is to design it in a shape that does not block the ear hole. to provide.

The step of designing the corrective device based on the modeling may be to design it in a shape that reflects the wrinkles of the ear and does not block the ear hole.

After scanning the shape of the deformed ear of the newborn that needs correction, the method may further include scanning the shape of the normal ear on the other side of the deformed ear.

The 3D data may be STL data.

The step of designing an orthodontic device based on the modeling may be a step of obtaining STL data of the designed orthodontic device.

The step of manufacturing the designed correction device using a 3D printer includes inputting the designed correction device STL data into a 3D printer to manufacture a casting mold capable of manufacturing the designed correction device by casting; Injecting a human body application material into the casting mold and then curing it; And it may include the step of separating the cured product from the casting mold and manufacturing a correction device.

The material applied to the human body may include a biocompatible medical silicone material.

The step of manufacturing the designed correction device using a 3D printer includes slicing the designed correction device STL data for 3D printing using a slicing program; Deriving G-code through the slicing; And it may include inputting the G-code into a 3D printer and 3D printing it.

The newborn may be less than 1 month old.

Another embodiment provides a patient-customized newborn ear correction device manufactured by the patient-customized newborn ear correction device manufacturing method.

Details of other aspects of the invention are included in the detailed description below.

Ear deformities in newborns occur in as many as 20% of cases. Ear correction products currently being used and sold only correct the folded part or bend the sharp part. According to one embodiment, regardless of the type of ear deformity that varies from patient to patient, customized manufacturing is possible considering ear wrinkles, etc., and above all, problems such as hearing abnormalities that occur while wearing the ear correction device do not occur at all. It does not cause any pain, is easy to wear, and has a short procedure time, making it possible to provide a newborn ear correction device that has a very high level of satisfaction for both the operator, the patient, and the patient's parents.

Figure 1 is a diagram sequentially showing a method of manufacturing a patient-customized neonatal ear correction device according to one embodiment.
Figure 2 is a flowchart briefly showing the steps for designing an ear correction device by scanning a patient's deformed ear.
Figure 3 is a flowchart briefly showing the steps for manufacturing the designed correction device by directly 3D printing it with a 3D printer.
Figure 4 is a flow chart briefly showing the steps of manufacturing the designed orthodontic device by casting using a mold (casting frame) using a 3D printer.
Figure 5 is a photograph showing a conventional ear correction device for newborns.

Hereinafter, embodiments of the present invention will be described in detail. However, this is presented as an example, and the present invention is not limited thereby, and the present invention is only defined by the scope of the claims to be described later.

In this application, terms such as “comprise” or “consist of” are intended to designate the presence of features, numbers, steps, operations, components, parts, or combinations thereof described in the specification, but are not intended to indicate the presence of one or more other features. It should be understood that this does not exclude in advance the possibility of the existence or addition of elements, numbers, steps, operations, components, parts, or combinations thereof.

Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by a person of ordinary skill in the technical field to which the present invention pertains. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with the meaning in the context of the related technology, and unless explicitly defined in the present application, should not be interpreted in an ideal or excessively formal sense. No.

In order to solve the problem of ear deformity in newborns, the present invention relates to an ear correction device that does not damage the skin tissue and hearing around the ear along with a material that can be contacted with the skin. Specifically, we aim to provide a neonatal ear correction device and manufacturing method that allows for personalized design through 3D scanning and has increased accuracy and convenience of operation. That is, the present invention is a method of manufacturing a corrective device for correcting ear deformity using 3D printing technology by scanning the deformed ear and the normal ear of a newborn in 3D and designing the deformed ear to fit the normal ear, and manufacturing it thereby. This relates to a corrective device for correcting ear deformities.

A method of manufacturing a patient-tailored newborn ear correction device according to one embodiment includes the steps of scanning the shape of a newborn's deformed ear in need of correction to obtain 3D modeled data; Extracting the 3D modeled data into 3D data; Modeling the shape of the orthodontic ear based on the three-dimensional data; designing a corrective device based on the modeling; and manufacturing the designed correction device using a 3D printer. At this time, the step of designing the corrective device based on the modeling is the step of designing it in a shape that does not block the ear hole.

As shown in Figure 5, the ready-made ear deformity correction devices currently on the market are in the form of blocked ear holes. Although the shape of a deformed ear can be changed to the shape of a normal ear by wearing such a ready-made ear correction device, For newborns whose hearing is not yet developed because their ear holes are blocked during the correction period, using these off-the-shelf ear deformity correction devices can cause significant disruption to the newborn's hearing development.

Accordingly, some are trying to make a model of a newborn's ear, manufacture a newborn ear correction device with a blocked ear hole based on it, and then drill holes in the manufactured newborn ear device and wear it on the newborn's deformed ear. However, in this case, not only did the position of the hole not correspond well to the newborn's ear hole, but the shape of the ear correction device was slightly deformed during the process of making the hole, which also resulted in a problem that the correction effect was deteriorated.

Not only does the shape of a newborn's ear vary greatly from person to person, but the ear hole of a newborn is too small, and the ear hole is connected to the eardrum in an open state. Therefore, it is difficult to manufacture a newborn ear correction device that exactly matches the newborn's ear hole by simply making a pattern. It was very difficult. Therefore, in hospitals and other fields, doctors or skilled personnel use medical wire as the core based on clinical judgment to directly manufacture newborn ear correction devices by wrapping the wire with medical silicone, etc., and apply it directly to the newborn's ears. This is being applied. Although this method is part of an effort to prevent newborns' earholes from being clogged, the corrective devices are manufactured on site by doctors, and are manufactured by the hands of adults, making it impossible to express even fine areas such as wrinkles. The reality is that even if problems such as hearing loss do not occur, the effect of accurately correcting the shape of the deformed ear to the shape of a normal ear is inevitably greatly reduced.

Accordingly, the present inventors were accurately aware of the existing problem and were thinking about ways to solve it. When manufacturing an ear correction device using a 3D printer, after 3D modeling, and designing the ear correction device on a computer based on this, they did not block the ear hole. It was confirmed that the conventional problems could be clearly solved when designed in a form that does not exist, and the present invention was completed.

For customized manufacturing, the operator uses a 3D scanner to scan the newborn's deformed ear and also scans the shape of the normal ear. This scan data is made three-dimensional, and using 3D CAD, the deformed ear is designed to match the shape of the normal ear, and the corrective device is designed to fit this, but in a form that does not block the ear hole. The orthodontic device designed in this way can be manufactured using 3D printing or casting using a mold, as described later. The ear correction device manufactured in this way can be fixed according to the operator's judgment and the correction time can be adjusted according to the progress and prognosis.

For example, the step of designing a corrective device based on the modeling may be to design it in a shape that reflects the wrinkles of the ear and does not block the ear hole. When designing the corrective device, in addition to designing it in a way that does not block the ear hole, if the fine wrinkles of the ear are also taken into account, the deformed ear of a newborn can be corrected to be almost identical to the shape of a normal ear.

In other words, while the conventional corrective devices or methods for correcting deformed ears, etc. all focused only on expressing the shape of the ear as close to normal after correction, the corrective device and its manufacturing method according to one embodiment not only focus on the shape after correction, but also on the shape of the ear after correction. It is compared to conventional correction devices or their manufacturing methods in that it fundamentally prevents problems that may arise during the correction process, specifically problems that may cause a loss of hearing in newborns by performing corrections on newborns with blocked ear holes for a long period of time. Therefore, it can be said that it corresponds to a new technology with a completely different composition.

For example, the step of scanning the shape of the deformed ear of the newborn that needs correction and then scanning the shape of the normal ear on the other side of the deformed ear may be further included. If only one ear of a newborn needs correction, and the other ear is a normal ear that does not require correction, a model of the contralateral ear requiring correction can be created based on the data from the contralateral normal ear, improving patient suitability. It can be improved.

For example, the 3D data may be STL data. If the 3D data is STL data, it can be very easy to use a 3D printer to later manufacture orthodontic devices. The three-dimensional data that serves as the basis for modeling the shape of the orthodontic ear may be various types of data, such as pts data, stl data, step data, iges data, etc. In one embodiment, the three-dimensional data in particular is stl data. By selecting , the manufactured orthodontic device can be implemented to have the shape most suitable for each newborn patient. The stl data is in the form of a triangular surface by connecting point to point, which is very advantageous in terms of visibility. Above all, since it is data that does not have the concept of a plane or a cylinder, it is difficult to design an orthodontic device based on the modeling. By going through the design process (by designing the orthodontic device based on the above modeling and obtaining STL data of the designed orthodontic device), a personalized orthodontic device for each newborn can be most perfectly implemented. In other words, according to the manufacturing method according to one embodiment, the corrective device must be designed in a way that does not block the ear hole, but since the position, size, and shape of the ear hole are different for each newborn, what kind of data is used as the 3D data? In addition, it is very important to realize the above effect according to one embodiment. By using STL data as the 3D data, it is possible to manufacture a correction device that does not block the ear hole and has a shape that is most suitable for each ear of a newborn that needs correction. there is.

For example, the step of designing an orthodontic device based on the modeling may be a step of obtaining stl data of the designed orthodontic device.

For example, the step of manufacturing the designed orthodontic device using a 3D printer includes inputting the designed orthodontic device stl data into a 3D printer to manufacture a casting mold capable of manufacturing the designed orthodontic device by casting; Injecting a human body application material into the casting mold and then curing it; And it may include the step of separating the cured product from the casting mold and manufacturing a correction device.

The step of manufacturing the casting mold may be a step of manufacturing the casting mold using a 3D printing method. This is because the resolution is high when using the 3D printing method.

The casting mold may be made of a hard material, a soft material, or a combination thereof. The material of the casting mold may be determined depending on the shape of the ear correction device to be manufactured. For example, when manufacturing an ear correction device in a shape in which the ear hole is not easily visible from the outside, a casting mold made of soft material should be used as needed, which may be more advantageous in manufacturing a correction device optimized for newborns who need correction. The manufacturing method according to one embodiment provides an ear correction device designed in a form that does not block the ear hole, so depending on the location or shape of the ear hole, etc., sometimes a casting mold is used rather than the method described later of directly manufacturing the correction device using a 3D printer. A manufacturing method using may be more advantageous.

For example, the material applied to the human body may include a biocompatible medical silicone material.

For example, the step of manufacturing the designed correction device using a 3D printer includes slicing the designed correction device STL data for 3D printing using a slicing program; Deriving G-code through the slicing; And it may also include inputting the G-code into a 3D printer and 3D printing it. This method is a method of directly manufacturing an orthodontic device using a 3D printer without using a casting mold, and can be more economical in that a casting mold does not need to be manufactured each time an orthodontic device is manufactured.

For example, the newborn may be less than 1 month old. The ear correction device manufactured using the manufacturing method according to one embodiment is a correction device that can be corrected through non-surgical treatment when the ear cartilage is in a flexible state, and excellent correction effects can be expected only when correction is performed within 1 month of birth.

According to another embodiment, a patient-customized neonatal ear correction device manufactured by the above manufacturing method is provided.

The present invention is not limited to the above-mentioned embodiments, but can be manufactured in various different forms, and those skilled in the art will be able to form other specific forms without changing the technical idea or essential features of the present invention. You will be able to understand that this can be implemented. Therefore, the embodiments described above should be understood in all respects as illustrative and not restrictive.

Claims (10)

Obtaining 3D modeled data by scanning the deformed ear shape of a newborn that needs correction;
Extracting the 3D modeled data into 3D data;
Modeling the shape of the orthodontic ear based on the three-dimensional data;
designing a corrective device based on the modeling; and
Including manufacturing the designed correction device using a 3D printer,
The step of designing the orthodontic device based on the modeling is to design it in a form that does not block the ear hole. Method of manufacturing a patient-customized neonatal ear correction device.
According to paragraph 1,
The step of designing the orthodontic device based on the modeling is to design it in a form that reflects the wrinkles of the ear and does not block the ear hole. A method of manufacturing a patient-customized neonatal ear correction device.
According to paragraph 1,
A method of manufacturing a patient-customized neonatal ear correction device further comprising scanning the shape of the deformed ear of the newborn that needs correction, and then scanning the shape of the normal ear on the other side of the deformed ear.
According to paragraph 1,
The three-dimensional data is STL data. A method of manufacturing a patient-customized newborn ear correction device.
According to paragraph 4,
The step of designing the orthodontic device based on the modeling is a method of manufacturing a patient-customized neonatal ear orthodontic device, which is the step of obtaining STL data of the designed orthodontic device.
According to clause 5,
The step of manufacturing the designed correction device using a 3D printer is
Inputting the designed orthodontic device STL data into a 3D printer to manufacture a casting mold capable of manufacturing the designed orthodontic device by casting;
Injecting a human body application material into the casting mold and then curing it; and
Separating the cured material from the casting mold and manufacturing a correction device
A method of manufacturing a patient-tailored neonatal ear correction device comprising.
According to clause 6,
The material applied to the human body is a method of manufacturing a patient-tailored newborn ear correction device including a biocompatible medical silicone material.
According to clause 5,
The step of manufacturing the designed correction device using a 3D printer is
Slicing the designed orthodontic device STL data for 3D printing using a slicing program;
Deriving G-code through the slicing; and
3D printing by inputting the G-code into a 3D printer
A method of manufacturing a patient-tailored neonatal ear correction device comprising.
According to paragraph 1,
A method of manufacturing a newborn ear correction device tailored to a patient in which the newborn is less than 1 month old.
A patient-tailored neonatal ear correction device manufactured by the manufacturing method according to any one of claims 1 to 9.