JP6818086B2 - Manufacturing method of 3D custom-made implant - Google Patents

Description

The present invention relates to a method for manufacturing an implant. More specifically, the present invention relates to a method for manufacturing a 3D custom-made implant capable of manufacturing a custom-made implant made of a material containing silicon based on a CT image of the patient's body.

Recently, cosmetics have not been able to meet the demand for anti-aging, and more and more consumers are trying to obtain a beauty effect by orthopedic treatment. Implants are used in the aforementioned plastic surgery, which involves various parts of the body, such as the nose, chin, nasolabial folds around the nose, recessed areas near the nose, under the eyes, and forehead. , It is made up of gluteal muscles.

Among them, there are many types of rhinoplasty, and the type of surgery differs depending on the patient's condition, requirements, type of deformity, type and method of previous surgery, and the like.

Rhinoplasty covers a wide range of areas, from simply raising or straightening a bent nose to correcting congenital malformations, healing defects due to accidents, and rebuilding the nose after removal of cancerous tissue. Includes a wide range of fields. Of these, nasal prosthesis should be performed for orthodontic treatment or for cosmetic purposes when the nose is congenitally low or deformed, or when the nose is defective or deformed due to tumor surgery or the like. There is.

Rhinoplasty is generally performed by inserting a material, which is divided into a graft and an implant.

The types of implants are bone and cartilage, and bone is divided into chondricular bone formed by ossification of cartilage and mesenchymal bone formed by direct ossification of mesenchymal tissue.

In general, membranous bone such as skull has a good survival rate and low resorption rate, and is often used for autologous bone grafting. In addition, chondricular bone such as ilium and ribs may be used. Cartilage has a lower absorption rate than bone tissue, can survive without blood supply, and is easy to shape. Nasal septal cartilage, auricular cartilage, and costal cartilage are mainly used for nasal prosthesis.

Among the transplants, in the case of bone grafts, the bone graft is firmly formed, does not displace well, does not cause a foreign body reaction, and a large amount can be obtained.

However, fractures can occur, transplants are difficult to collect, donors can be scratched, cumbersome, highly absorptive, and inflexible. Of the autologous cartilage, the nasal septal cartilage is convenient, but the amount is not large and it is difficult to form a solid nasal dorsal line.

An insert means an inert artificial material that does not cause chemical changes even when placed in a living tissue for a long period of time, and is a silicone prosthesis, a Gore-Tex® prosthesis, or a Mersilene (registered). There are types such as mesh, aloderm (registered trademark), and proplast.

On the other hand, existing materials for rhinoplasty used in rhinoplasty have been produced in standard length and height without considering the size of the nose of an individual patient. Therefore, doctors have spent a lot of time designing and engraving materials according to the specific requirements of each patient.

Tissue engineering techniques based on traditional stem cell research have shown the potential to replace damaged tissues and organs while maintaining their unique function, but the application of tissue engineering techniques in orthopedics is relatively rare. .. That is, in most cases, the use of suitable materials to achieve the main purpose in orthopedics is essential.

Recently, three-dimensional (3D) printing has been applied to various clinical problems, and three-dimensional printing can be used to produce solid scaffolds in three-dimensional shape.

However, none of the previous studies applied 3D printing to nasal plastic surgery or nasal surgery.

The reason why the nose, which is the number one orthopedic site, is not produced by custom-made implants is that up to 1/3 of the upper part of the nose is bone, but the lower 2/3 part is non-bone cartilage and cartilage. Since it is a muscle layer that covers the cartilage, it was not embodied on CT (computed tomography). Therefore, it was difficult to produce implants suitable for human tissues such as cartilage and bone.

In addition, custom-made implants such as chin, nasolabial fold (paranasal), forehead, temple wrinkle (paranasal), mandible, temple, cheekbone (Malar) that fit perfectly to the facial bone are also limited to materials. It was difficult to produce.

The above-mentioned technical configuration is a background technique for deepening the understanding of the present invention, and does not mean a conventional technique well known in the technical field to which the present invention belongs.

Korean Registered Patent Gazette No. 10-1747326 (Sim Minbo) 2017.06.08.

The present invention has been devised in view of the above points, and provides a method for manufacturing a 3D custom-made implant capable of manufacturing a custom-made implant made of a material containing silicon based on a CT image of a patient's body. The purpose is.

According to one aspect of the present invention, a CT image of the patient's body is divided based on the brightness value of the body image using a threshold (Treshholding), and then a 3D object (implant) of the body is realized. The design stage of designing a design implant based on the 3D object embodied in the materialization stage; the guideline implant manufacturing stage of manufacturing a design implant according to the guideline; and customizing with a material containing silicon in the same form as the guideline implant. It is possible to provide a method for manufacturing a 3D custom-made implant, including a manufacturing stage for manufacturing the made-made implant.

The design stage may further include the stage of obtaining confirmation of the customer including the hospital.

The guideline implant manufacturing stage can be manufactured using a 3D printer.

The custom-made implant manufactured in the guideline implant manufacturing stage can be provided as a guideline for presenting the shape and shape.

At the manufacturing stage, the custom-made implant can be manufactured by a manufacturing method including milling and casting.

The production step is a step of kneading the gypsum and then immersing the guideline implant in one surface of the kneaded first kneaded gypsum to a certain depth; after kneading the second kneaded gypsum in the same manner as the first kneaded gypsum. The step of covering the first kneaded gypsum; the step of removing the guideline implant after curing the first kneaded gypsum and the second kneaded gypsum; and the step of removing the guideline implant; and the liquid form in the gap created by the removal of the guideline implant. It can include a step of injecting a material containing silicon and then curing.

A CT image of the existing patient's body can be used at the implementation stage.

The method for manufacturing a 3D custom-made implant of the present invention can manufacture a custom-made implant made of a material containing silicon based on a CT image of a patient's body.

It is a sequence diagram which schematically illustrated the manufacturing method of the 3D custom-made implant by one Example of this invention. FIG. 1 is a drawing schematically showing that the bones, cartilage and muscles of the nose were embodied in the CT image by the illustrated embodying stage. FIG. 1 is a drawing schematically showing that a design nasal implant designed at the illustrated design stage was provided on the upper side of the bone. As an example of a custom-made implant manufactured by the manufacturing method of FIG. 1, it is a drawing which schematically shows a nasal implant. FIG. 2 is a drawing schematically showing that the illustrated nasal implant was attached to a model bone. It is a drawing which roughly illustrated that this Example can be applied to a forehead, a chin, etc. in addition to a nose.

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

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

FIG. 1 is a sequence diagram schematically showing a method of manufacturing a 3D custom-made implant according to an embodiment of the present invention, and FIG. 2 shows a CT image of nasal bone, cartilage, and a CT image according to the embodiment shown in FIG. It is a drawing which roughly illustrates the realization of human body tissue such as muscle, and FIG. 3 shows that the design nasal implant designed at the design stage shown in FIG. 1 is provided on the upper part of the bone. FIG. 4 is a drawing schematically showing a nasal implant as an example of a custom-made implant manufactured by the manufacturing method of FIG. 1, and FIG. 5 is a drawing showing a nasal implant illustrated in FIG. It is a drawing which roughly illustrated that was attached to a model bone.

As illustrated in these drawings, the method of manufacturing a 3D custom-made implant according to this embodiment converts a CT (computed tomography) image of a patient's nose into light and dark values of human tissues such as nose bone 10, cartilage 30 and muscle 20. Based on this, an example of a design implant based on the realization stage S10 that embodies the nose bone 10, cartilage 30, muscle 20, etc. in the CT image after dividing using the thresholding, and the CT image embodied in the realization stage. The design stage S20 for designing the design nasal implant 200, the guideline nasal implant manufacturing stage S30 which is an example of the guideline implant for manufacturing the design nasal implant 200 according to the guideline, and the material containing silicon in the same form as the guideline nasal implant. It includes a manufacturing stage S40 for manufacturing a nasal implant 100, which is an example of a custom-made implant.

In the realization stage S10, a CT image of the nose is first acquired via a CT device, and the CT image of the nose can be acquired via a conventional CT imaging device. Also, in this embodiment, the CT image of the nose can be obtained through a customer, for example, a hospital.

In the embodiment step S10 of this embodiment, the nose bone 10, cartilage 30, and muscle 20 can be embodied in the CT image of the nose and the CT image shown in FIG. 2 using the light and dark values.

Specifically, previously, up to 1/3 of the upper part of the nose was bone, but the lower 2/3 part is the non-bone cartilage 30 and the muscle 20 layer covering the cartilage 30, so it is on CT. The design nasal implant 200 shown in FIG. 2 could not be realized.

However, in this example, when the CT image of the patient is binarized by utilizing the partial 2D image, each light and dark value can be classified, and this partial value and the like can be used as cartilage. It is possible to express detailed parts such as bones and muscles. That is, the principle of classifying this means the work of classifying by the same value according to the degree of brightness of the pixel (Pixel) using the partial 2D image of the CT image.

In this embodiment, the light and dark values required by the operator are selected from the values classified using the binarization work, and the values are converted into an STL (StereoLithography) file for 3D imaging.

After conversion in this embodiment, the shape in which each STL file required for production is integrated is used 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 the file format provided for saving 3D modeled data as a standard format file.

The design stage S20 is a stage of designing the design nasal implant 200, which is an example of the design implant, based on the CT image embodied in the materialization stage S10.

In this embodiment, the design nasal implant 200 manufactured in the design stage S20 can be manufactured according to the requirements written in the customer's order form.

In addition, in this embodiment, the manufactured design nasal implant 200 can be confirmed through the customer's hospital. If there is a hospital revision request during this confirmation process, the design nasal implant 200 can also be manufactured via the implementation step S10 described above.

Further, in this embodiment, the design nasal implant 200 can be manufactured in two or three types and provided to a customer hospital.

The guideline implant manufacturing stage S30 is a stage in which the design nasal implant 200 is manufactured with the guideline implant.

The guideline nasal implant, which is an example of the guideline implant in this example, can be manufactured using a 3D printer or via a mold. For example, in this embodiment, the guideline implant is manufactured through a method of outputting a model designed using a 3D printer or outputting a skull with a 3D printer and then directly designing the implant using an epoxy material. can do.

The manufacturing stage S40 is a stage in which a custom-made implant containing the nasal implant 100 is manufactured from a material containing silicon in the same form as the guideline nasal implant confirmed by the customer.

In the manufacturing step S of this embodiment, the nasal implant 100 can be provided by a manufacturing method including milling, casting and the like.

Hereinafter, the production of the nasal implant 100 by the casting manufacturing method will be briefly described.
First, after kneading the gypsum, a step of immersing the guideline nasal implant at a certain depth on one surface of the kneaded first kneaded gypsum is performed. At this stage, the guideline nasal implant is immersed in the first kneaded gypsum by about 2/3. For the gypsum in this example, known yellowstone kneading can be used, which can also be applied in the production of the second kneaded gypsum.

Next, after kneading the second kneaded gypsum in the same manner as the first kneaded gypsum, a step of covering the first kneaded gypsum is performed.

Next, wait until the first kneaded gypsum and the second kneaded gypsum are completely cured. In this example, the curing time of the first kneaded gypsum and the second kneaded gypsum is about 24 hours.

When cured or completed, either one of the first kneaded gypsum and the second kneaded gypsum is separated and the guideline nasal implant is removed.

Guideline After removing the nasal implant, silicone in liquid form is injected into the gap between the first kneaded gypsum and the second kneaded gypsum, and then cured at a constant temperature for a certain period of time.

In this example, the above-mentioned constant temperature may be a temperature of about 160 degrees Celsius, and the curing time is 1 to 2 hours. In this embodiment, in addition to silicon in the liquid form, other known materials such as titanium can also be injected.

After the above-mentioned curing time has elapsed, the first kneaded gypsum and the second kneaded gypsum are removed, and then the nasal implant 100 is separated.

The separated nasal implant 100 is prepared according to the same standard as the guideline nasal implant, surface-treated, and then washed to finish.

The present embodiment then includes a method of manufacturing an implant by milling.
Hereinafter, a method for manufacturing an implant by milling will be briefly described. Milling means a method of manufacturing by shaving or trimming a physical characteristic material such as block type silicon according to the designed implant, and it is manufactured by hand carving by a technician in addition to milling. can do.

On the other hand, this example is used to manufacture implants necessary for the chin, nasolabial fold (paranasal), forehead, temple wrinkle (paranasal), mandible, temple, cheekbone (Malar), etc. Can be applied. FIG. 6 schematically illustrates that this embodiment can be applied not only to the nose but also to the forehead, chin, temple wrinkles, and the like.

In the examples of the present invention, the CT image of the patient's body is divided using a threshold value based on the light and dark values of the body, and the divided values (data) required by the producer are selected from the divided light and dark values. Bring it in and convert it to an STL file, design the patient's implant on a 3D object that is a shape that integrates each STL file required for production, output the designed STL file, and sample the produced 3D shape By manufacturing with custom-made implants with physical properties including silicon, it is possible to provide a virtual design, more accurately reflect the customer's request, communicate smoothly with the customer, and better meet the customer's request. It can be reflected a lot.

As described above, in this embodiment, the CT image of the patient's body is converted into a 3D object shape by designing the implant based on the brightness value of the body, and then the converted 3D shape is used as a sample to customize the physical properties including silicon. By manufacturing with made implants, it is possible to provide a virtual design, more accurately reflect the customer's request, communicate smoothly with the customer, and reflect the customer's request more. ..

Another major advantage is that the side effects of surgery are reduced by matching the implants designed in the patient's bones and tissues with the object space, and the individual preference can be reflected more accurately. In this embodiment, the object space is defined as a space in which an object exists on a three-dimensional coordinate system on a three-dimensional surface. That is, it is an implant of a space created by a threshold value based on a light / dark value.

As described above, it is obvious to those who have ordinary knowledge in the field of the art that the present invention can be modified and modified in various ways without being limited to the described examples and without departing from the events and scope of the present invention. Is. Therefore, it should be said that such a modified example or a modified example belongs to the scope of claims of the present invention.

10 Nose bone 20 Nose muscle 30 Nose cartilage 40 Existing implant 100 Nose implant 200 Designed nose implant

Claims (7)

After dividing the CT image of the patient's body using the threshold value based on the brightness value of the body image, the realization stage of embodying the 3D object of the body;
With the design stage of designing a design implant based on the 3D object embodied in the materialization stage;
Guidelines implant fabrication steps for fabricating the designed implant guidelines; the same form as, and the guidelines implant, viewed contains a fabrication step of fabricating a custom implant material containing silicon,
The CT image is a CT image of the nose, and the light and dark values are light and dark values of bones, cartilage and muscles of the nose.
In the realization stage, the light and dark values required by the operator are selected from the divided light and dark values, converted into an STL file, and after conversion, the shape in which each STL file is integrated is used as the 3D object. , A method for manufacturing a 3D custom-made implant that embodies the bone, cartilage, and muscle of the nose on the CT image . The method for manufacturing a 3D custom-made implant according to claim 1, wherein the design stage further includes a stage of obtaining confirmation of a customer including a hospital. The method for manufacturing a 3D custom-made implant according to claim 1, wherein the guideline implant manufacturing stage is manufactured using a 3D printer. The Guidelines implant guidelines implants fabricated with fabrication stage, a manufacturing method of a 3D custom implant according to claim 1, characterized in that it is provided as a guideline for presenting the shape. The method for manufacturing a 3D custom-made implant according to claim 1, wherein the custom-made implant is manufactured by a manufacturing method including milling and casting at the manufacturing stage. The production stage is
After kneading the gypsum, the step of immersing the guideline implant at a certain depth on one side of the kneaded first kneaded gypsum;
After kneading the second kneaded gypsum in the same manner as the first kneaded gypsum, the stage of covering the first kneaded gypsum;
The step of removing the guideline implant after curing the first kneaded gypsum and the second kneaded gypsum; and after injecting a material containing silicon in a liquid form into the gap created by the removal of the guideline implant and then curing. The method for manufacturing a 3D custom-made implant according to claim 1, which includes a step of making a gypsum implant. The method for manufacturing a 3D custom-made implant according to claim 1, wherein a CT image of an existing patient's body is used at the embodiment.