KR20210040338A - Manufacturing method for customized implant - Google Patents

Abstract

Disclosed is a manufacturing method for an implant for a human body. The manufacturing method of an implant for a human body of the present invention comprises the following steps: after kneading plaster, immersing a sample implant for the human body including a guide line nose implant on one side of the kneaded first plaster to a predetermined depth; after kneading the second plaster in the same manner as the first plaster, covering the first plaster with the second plaster; removing the sample implant for the human body after curing the first plaster and the second plaster; and injecting a material containing liquid silicone between a gap created by the removal of the sample implant for the human body and then curing the material. According to embodiments of the present invention, it is possible to efficiently reproduce a guide implant including silicone of different physical properties through a curing process.

Description

Manufacturing method for customized implant {Manufacturing method for customized implant}

The present invention relates to a method of manufacturing an implant, and more particularly, to a method for manufacturing a customized implant that includes a nasal implant and can efficiently reproduce the guide implant into an implant of other physical properties including silicone.

In general, silicone implants are used for the purpose of reconstruction of tissue defects due to diseases and accidents, cosmetic plastic surgery, and plastic surgery due to deformities, and are used for the purpose of replacing organs or tissues in three dimensions and anatomy.

For example, among the faces that occupy the greatest weight of the aesthetic standard, the tendency to prefer large and high noses like Westerners is remarkable, and thus, rhinoplasty (隆鼻術, rhinoplasty) is becoming popular.

The types of rhinoplasty are very diverse, and the type of surgery varies depending on the patient's condition, needs, type of transformation, and the type and method of previous surgery. Rhinoplasty includes a wide range of areas, from simple surgery to raise or correct a curved nose, to correct congenital anomalies, to heal defects caused by accidents, and to reconstruct the nose after removal of cancerous tissue. Among them, apnea can be performed for corrective treatment or cosmetic purposes when there is a congenital low or deformed nose, or a defect or deformity in the nose area due to tumor surgery or the like.

In general, jungbisurgery is made by inserting materials, and the materials can be divided into grafts and implants.

The types of implants include bone and cartilage, and bone can be divided into cartilage bone formed by ossification of cartilage and membranous bone formed by direct ossification of mesenchymal tissue.

In general, membranous bones such as skulls have good survival rates and low absorption rates, so they are often used for autologous bone transplantation. In addition, cartilage bones such as iliac bones and ribs are also used. Cartilage has a lower absorption rate than bone tissue, can survive without blood supply, and is easy to shape. Nasal septal cartilage, ear cartilage, and rib cartilage are mainly used for chondrology. In the case of bone grafts among implants, the bone fusion is firm and does not displace well, and does not cause a foreign body reaction, but it is difficult to obtain a large amount.

However, fractures can occur, the implants are difficult to collect, scars can remain on the donor, difficult to handle, high absorption, and inflexible. Among autologous cartilage, nasal septal cartilage is convenient and good, but it is not in large quantity, and it is difficult to form a solid nasal dorsal line.

The implant refers to an inert artificial material that does not cause chemical changes even if it is placed in the tissue of a living body for a long period of time, and there are types such as silicone implants, Gore-Tex implants, mercilin mesh, and alloderm proplast.

On the other hand, conventional auxiliaries materials used in rhinoplasty have been produced in standard lengths and heights without considering the size of the nose of individual patients. Therefore, doctors have spent a lot of time designing and sculpting materials according to the specific needs of each patient. Although tissue engineering technology based on conventional stem cell research has shown the possibility to replace damaged tissues and organs while maintaining its own function, the application of tissue engineering technology in plastic surgery is relatively rare. That is, in most cases, it is essential to use an appropriate material to achieve the main purpose in plastic surgery.

Recently, 3D printing has been applied to various clinical problems, and 3D printing can be used to manufacture a solid scaffold with a 3D shape.However, no previous studies have applied 3D printing to rhinoplasty or nose surgery. Did.

The reason why the nose, which is the No. 1 cosmetic part, is not produced as a customized implant is bone up to the upper third part of the nose, but the lower 2/3 part is the muscle layer covering the cartilage and cartilage, not bone, so on CT (computed tomography) Not implemented. Therefore, it has been difficult to produce implants suitable for human tissues such as cartilage and bone.

In addition, customized implants such as the jaw, paranasal, forehead, mandible, temple, and malar that exactly match the facial bones were also difficult to produce due to the limitations of materials.

The above-described technical configuration is a background technique to aid understanding of the present invention, and does not mean a conventional technique widely known in the art to which the present invention pertains.

Korean Patent Application Publication No. 22016-0133047 (Kim Yong-gyu) 2016. 11.

Therefore, the technical problem to be achieved by the present invention is to provide a method for manufacturing a customized implant that includes a guide implant and can efficiently reproduce the implant for a sample into an implant of other physical properties including silicon. In this case, the guide implant includes a guide implant output through 3D design or a guide implant made of carving, and a guide implant made in a model.

In addition, implants for human implantation can be facial implants (forehead, nose, jaw, mandible, paranasal, malar) and body implants (Poland syndrome, calves, shoulders, etc.).

According to an aspect of the present invention, after kneading the gypsum, dipping a guide line implant including a guide line nasal implant on one side of the kneaded first kneaded gypsum to a predetermined depth; Kneading a second kneaded gypsum in the same manner as the first kneaded gypsum, and then covering the second kneaded gypsum on the first kneaded gypsum; Removing the guide line implant after curing the first and second plasters; And there may be provided a method for manufacturing a customized implant comprising the step of injecting a material containing a liquid silicone between the gaps created by the removal of the guide line implant and then curing.

The curing performed after injecting the liquid silicone-containing material may be performed between 150 degrees Celsius and 170 degrees Celsius.

The curing may be performed for 1 to 2 hours.

It may further include the step of trimming and surface-treating the implant for human insertion obtained after the curing step to the same standard as the guide line implant.

It may further include the step of washing the surface-treated implant for human insertion.

The guideline nasal implant divides a CT image of a patient's nose using thresholding values based on intensity values such as bones, cartilage, and muscles of the nose, and divides the CT image into bones, cartilage, and muscles of the nose. An implementation step of implementing the etc.; A design step of designing a design implant based on the CT image implemented in the implementation step; And a guide line implant manufacturing step of manufacturing the design implant as a guide.

The step of manufacturing the guideline implant may be manufactured using a 3D printer.

In addition, a guideline implant may be manufactured through manufacturing through carving or through model manufacturing using a material such as epoxy.

In the embodiments of the present invention, the first and second plasters, guideline implants, liquid silicone, and curing processes allow the guide implant to be efficiently reproduced into implants of other physical properties including silicone.

1 is a flow chart schematically showing a method of manufacturing a customized implant according to an embodiment of the present invention.
2 is a diagram schematically showing a nose implant manufactured by the manufacturing method of FIG. 1.
3 is a diagram schematically showing a human body tissue including bones, cartilage, and muscles of the nose is implemented on a CT image by the implementation step.
FIG. 4 is a diagram schematically illustrating that a design nasal implant designed in the design stage to manufacture the guideline nasal implant described in FIG. 1 is provided on human tissues such as bone and cartilage.
5 is a diagram schematically showing that the nose implant shown in FIG. 2 is accurately matched on a model bone and cartilage.
6 is a diagram schematically showing that the present embodiment can be applied to the forehead, chin, nasolabial folds (paranasal), and the like.

In order to fully understand the present invention, operational advantages of the present invention, and objects achieved by the implementation of the present invention, reference should be made to the accompanying drawings illustrating preferred embodiments of the present invention and the contents described in the accompanying drawings.

Hereinafter, the present invention will be described in detail by describing a preferred embodiment of the present invention with reference to the accompanying drawings. The same reference numerals shown in each drawing indicate the same members.

1 is a flow chart schematically showing a method of manufacturing a customized implant according to an embodiment of the present invention, FIG. 2 is a schematic view showing a nasal implant manufactured by the manufacturing method of FIG. 1, and FIG. 3 is an implementation It is a diagram schematically showing the implementation of human tissues such as bones, cartilage, and muscles of the nose on a CT image by the steps, and FIG. 4 is a design nose implant designed in the design phase to manufacture the guideline nasal implant shown in FIG. It is a diagram schematically showing what is provided on human tissues such as bone and cartilage, and FIG. 5 is a diagram schematically showing that the nasal implant shown in FIG. 2 is accurately matched on the model bone and cartilage.

As shown in these drawings, the method for manufacturing a customized implant according to the present embodiment includes the steps of immersing a guide line implant including a guide line nasal implant on one side of the first kneaded gypsum kneaded after kneading the gypsum to a predetermined depth. Step (S100) and, after kneading the second kneaded gypsum in the same manner as the first kneaded gypsum, and then covering the second kneaded gypsum on the first kneaded gypsum (S200), and after curing the first and second kneaded gypsum Obtained after the step of removing the guide line implant (S300) and the step of injecting and curing a material containing silicone in a liquid form between the gaps created by the removal of the guide line implant (S400), and the step of curing. It includes a step (S500) of trimming and surface-treating the implant for human implantation to the same standard as the guideline implant (S500), and a step (S600) of cleaning the surface-treated implant for human implantation.

In this embodiment, the guide line implant may be an original model for producing an implant for inserting a human body that is finally produced. In addition, in this embodiment, the guide line implant may include a guide line nose implant, and may be manufactured by a 3D printer.

In step S100 of immersing the guide line implant to a predetermined depth, the guide line nose implant, which is an example of the guide line implant, may be immersed in the first kneaded plaster about 2/3. In this embodiment, the gypsum may be a known yellow stone (yellow stone) dough, which can be applied equally to the manufacture of the second plaster.

In this embodiment, the guideline nasal implant uses a computed tomography (CT) image of the patient's nose based on the contrast values of human tissues such as bones 10, cartilage 30, and muscles 20 of the nose. The nose implant 200 is designed based on the implementation stage of implementing human tissues, such as the bones 10, cartilage 30, and muscles 20 of the nose, and the CT images implemented in the implementation stage after segmentation using the CT image. ), and a guideline nasal implant manufacturing step of manufacturing the design nasal implant 200 as a guide.

In the implementation stage, first, a CT image of the nose is acquired through a CT device, and the CT image of the nose may be acquired through a conventional CT imaging device. In addition, in this embodiment, the CT image of the nose may be received through a customer, for example, a hospital.

The implementation step of the present embodiment is a method of dividing the nose CT image using a thresholding value based on the contrast values of human tissues such as the bones 10, cartilage 30, and muscle 20 of the nose. Human tissues such as the bones 10, cartilage 30, and muscles 20 of the nose may be implemented in the CT image shown in FIG. 3.

Specifically, in the past, until the upper third part of the nose is bone, but the lower 2/3 part is not bone, but the muscle 20 layer and soft tissue covering the cartilage 30 and so on the CT shown in FIG. 3 The illustrated design nose implant 200 could not be implemented.

However, in this embodiment, if the patient's CT image is thresholded using a slice 2D image, each intensity value can be classified, and these partial values can be used for detailed areas such as cartilage, bone, and muscle. I can express it. In other words, the principle of classifying them refers to a task of distinguishing the same values according to the intensity of the pixels by using a partial 2D image of a CT image.

The present embodiment selects a contrast value required by an operator from among values classified using a boundary operation, and converts it into a stereolithography (STL) file for 3D imaging. In this embodiment, after conversion, a shape in which each STL file required for production is integrated is referred to as a 3D object. Next, the patient's implant is designed on the 3D object, and the designed STL file is output. For reference, the STL file refers to a file format provided to save 3D modeled data as a standard format file.

The design step is a step of designing the design nose implant 200 based on the CT image implemented in the implementation step.

In this embodiment, the design nose implant 200 manufactured in the design stage may be manufactured according to the request written on the customer's order form.

In addition, in this embodiment, the designed nose implant 200 may be confirmed through a hospital that is a customer. If there is a request for correction from the hospital during this verification process, the designed nose implant 200 may be manufactured again through the above-described implementation step (S10).

Furthermore, in the present embodiment, the designed nose implant 200 may be manufactured in 2 to 3 types and provided to a hospital, which is a customer.

The guideline nasal implant manufacturing step is a step of manufacturing the designed nasal implant 200 as a guideline nasal implant.

In this embodiment, the guideline nose implant may be manufactured using a 3D printer or through a mold. For example, in this embodiment, the guideline implant can be produced by printing a model designed using a 3D printer or printing a skull using a 3D printer, and then directly designing the implant using an epoxy material. Do.

The step of covering the second plaster plaster (S200) may be performed by kneading the second plaster plaster in the same manner as the first plaster plaster and then covering the plaster plaster.

In the step of removing the guide line implant (S300), a step of waiting for the first kneaded gypsum and the second kneaded gypsum in which the guide line nasal implant, which is an example of the guide line implant, are completely hardened is performed first. In this embodiment, the curing time of the first plaster and the second plaster may take about 24 hours.

When curing is complete, either the first or second plaster is separated to remove the guideline nasal implant.

In the step of injecting and curing a material containing liquid silicone (S400), after removing the guideline nasal implant, liquid silicone is injected between the gaps between the first and second plasters, and then at a certain temperature. It can be made by curing again for a certain time. In this embodiment, the above-described constant temperature may be about 150 to 170 degrees Celsius, and the curing time may be performed for 1 to 2 hours. In this embodiment, in addition to liquid silicon, other known materials such as titanium may be injected.

When the above-described curing time has elapsed, the first and second plasters are removed, and then the nose implant 100 is separated.

The surface treatment step (S500) is a step of trimming and surface-treating the separated nasal implant 100 to the same standard as the guideline nasal implant, and the nasal implant 100 having the surface treatment completed is washed in the washing step (S600). This can be done.

In this embodiment, the nose implant 100 may be manufactured by a manufacturing method including milling.

Hereinafter, a method of manufacturing a nasal implant by milling will be briefly described. Milling refers to a method of manufacturing by cutting or trimming physical properties such as block-type silicone for a designed nose implant. In addition to milling, it can be manufactured by hand-cutting (carving) by a technician.

In addition, in the present embodiment, in addition to the above-described nose, body parts that require shaping, such as the chin, paranasal around the nose, recessed areas on the side of the nose, under the eyes, forehead, gluteal, mandible It can also be applied to manufacturing implants such as mandible, temple, malar, Polish syndrom, calf and shoulder. 6 schematically shows that this embodiment can be applied to the forehead, chin, temporal wrinkles, etc. in addition to the nose.

As described above, in this embodiment, a CT image of the patient's body is converted into a 3D object shape based on the body's contrast value, and then the converted 3D shape is used as a sample to provide a customized implant with physical properties including silicon. By making it possible to provide a virtual design, it is possible to more accurately reflect the customer's request, and smooth communication with the customer is possible, so that the customer's request can be more diversely reflected.

In addition, there is a great advantage in that the side effects of surgery are also reduced in that the bones and tissues of the patient and the implant designed in the object space are matched, and that individual preferences can be more accurately reflected. In this embodiment, the object space may be defined as a space in which an object exists on a three-dimensional coordinate system on a three-dimensional surface. In other words, the space created by the boundary value based on the contrast value is implanted.

As described above, the present invention is not limited to the described embodiments, and it is obvious to those of ordinary skill in the art that various modifications and variations can be made without departing from the spirit and scope of the present invention. Therefore, such modifications or variations will have to belong to the scope of the claims of the present invention.

10: bone of the nose
20: muscles of the nose
30: ointment from the nose
40: existing implant
100: nose implant
200: Design nose implant

Claims (1)

Kneading the gypsum and immersing the guide line nose implant on one side of the kneaded first kneaded gypsum to a predetermined depth;
Kneading a second kneaded gypsum in the same manner as the first kneaded gypsum, and then covering the second kneaded gypsum on the first kneaded gypsum;
Removing the guide line nasal implant after curing the first and second plasters; And
Injecting a material containing silicone in a liquid form between the gaps created by the removal of the guideline nose implant and then curing,
The guideline nasal implant divides a CT image of a patient's nose using a threshold based on the contrast values of human tissues including bones, cartilage, and muscles of the nose, and divides the nose bones into the CT image. , Implementation step of implementing a human body tissue including cartilage and muscle; A design step of designing a design nose implant based on the CT image implemented in the implementation step; And manufacturing the design nasal implant in a guideline nasal implant manufacturing step of manufacturing a sample,
Implement the bones, cartilage, and muscles of the nose in the CT image using the intensity value,
Among the values divided using the threshold value, the operator selects the contrast value required by the operator and outputs it to an STL file,
The curing performed after injecting the material containing the liquid silicone is performed between 150 degrees Celsius to 170 degrees Celsius,
The curing is performed for 1 to 2 hours,
Further comprising the step of trimming and surface-treating the implant for human insertion obtained after the curing step to the same standard as the guideline nasal implant,
A method of manufacturing a customized implant further comprising the step of washing the surface-treated implant for human implantation.

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