Method for manufacturing artificial nipple prosthesis using 3D scanning and printing

Abstract

According to an embodiment of the present invention, provided is a method for manufacturing an artificial nipple prosthesis, the method comprising the steps of: performing a scan of a nipple and areola region of a body through 3D scanning, and converting the surface reconstructed from scan data from raised to recessed; obtaining a printed mold by performing 3D printing on the basis of the scan data converted to recessed; applying silicone to the printed mold to prepare a silicone mold; separating the silicone mold from the printed mold, pouring addition silicone into the silicone mold, and curing the addition silicone; and separating the cured addition silicone from the silicone mold to obtain a silicone model.

Description

Method for manufacturing artificial nipple prostheses using 3D scanning and printing

[0001] The present invention relates to a method for manufacturing an artificial nipple prosthesis using 3D scanning and printing, and more particularly, to a manufacturing method that stores 3D scan data as a digital file, so that storage space is not required, it can be reused at any time, and it enables the production of a precise prosthesis tailored to an individual's body.

[0002] Prosthetics are often made of silicone, a material that is harmless to the human body, to avoid causing discomfort or resistance in the surgical area.

[0003] For example, they are sometimes used as artificial breasts by filling a silicone pouch (shell) with a filler. Such fillers may include saline, hydrogel, or silicone gel.

[0004] These implants are widely used for cosmetic purposes to correct the shape or enlarge the size of specific body parts such as the nose, breasts, or buttocks due to their durability and superior texture.

[0005] Meanwhile, artificial nipple prostheses have been developed for patients who do not want or cannot undergo nipple reconstruction to help them regain psychological stability and self-confidence while recovering from breast cancer surgery.

[0006] Artificial nipple implants are attached to the surface of a woman's breast, and it is important that they have a similar texture and color to a real nipple.

[0007] However, conventional artificial nipple implants are insufficient to provide users with sufficient self-confidence because they differ from the texture, color, and shape of real nipples.

[0008] The present invention is intended to solve the problems of the above-mentioned prior art.

[0009] The purpose of the present invention is to achieve a device that can reproduce the texture, color and shape of an actual nipple with great precision and achieve flexibility that can be customized to the skin tone and texture of various individuals.

[0010] The purpose of the present invention is to provide an artificial nipple prosthesis that provides a natural appearance and feel to the user, thereby enabling them to feel psychological stability and confidence.

[0011] The purpose of the present invention is to enable 3D scan data to be stored as a digital file, so that storage space is not required, it can be reused whenever necessary, and by using digital data, it is possible to manufacture precise prosthetics tailored to an individual's body.

[0012] The purpose of the present invention is to provide a method of reducing initial costs while obtaining the advantage of digital data storage by making a silicone mold after taking a sample using alginate and then 3D scanning it.

[0013] The purposes of the present invention are not limited to those mentioned above, and other purposes not mentioned will be clearly understood from the description below.

[0014] According to one embodiment of the present invention for achieving the above-described object, a method for manufacturing an artificial nipple prosthesis is provided, comprising the steps of: performing a scan of a nipple and areola area of ​​a body through 3D scanning, and converting a surface of the scan data from a positive to a negative shape; performing 3D printing based on the scan data converted to a negative shape to obtain a printing mold; applying silicone to the printing mold to produce a silicone mold; separating the silicone mold from the printing mold, pouring an additive silicone into the silicone mold, and curing it; and separating the cured additive silicone from the silicone mold to obtain a silicone model.

[0015] The step of pouring the additive silicone into the silicone mold and curing it may include the step of attaching a film coated with a release agent after pouring the additive silicone; and the step of applying pressure to the film to control the thickness and shape of the product.

[0016] The above method for manufacturing an artificial nipple prosthesis may further include a step of performing coloring on the surface of the silicone model through layering.

[0017] An artificial nipple prosthesis according to one embodiment can reproduce the texture, color, and shape of a real nipple with great precision, and can achieve flexibility to be customized to the skin tone and texture of various individuals.

[0018] An artificial nipple prosthesis according to one embodiment provides a natural appearance and feel to the user, thereby providing psychological stability and confidence.

[0019] In one embodiment, because 3D scan data can be stored as a digital file, there is no need for storage space, it can be reused whenever needed, and because digital data is used, it becomes possible to manufacture precise prosthetics tailored to an individual's body.

[0020] In one embodiment, a method of creating a silicone mold using alginate and then 3D scanning it can reduce initial costs while gaining the advantage of digital data storage.

[0021] Figure 1 is a drawing showing the shape of a mold converted into a positive shape and scan data.

[0022] The following detailed description of the present invention refers to the accompanying drawings, which illustrate specific embodiments in which the present invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the present invention. It should be understood that the various embodiments of the present invention, while different from each other, are not necessarily mutually exclusive. For example, specific shapes, structures, and characteristics described herein may be implemented in other embodiments without departing from the spirit and scope of the present invention. Furthermore, it should be understood that the positions or arrangements of individual components within each disclosed embodiment may be modified without departing from the spirit and scope of the present invention. Accordingly, the following detailed description is not intended to be limiting, and the scope of the present invention is defined only by the appended claims, along with the full scope of equivalents to which such claims are entitled, if properly described. Like reference numerals in the drawings designate the same or similar functionality throughout the several aspects.

[0023] Hereinafter, preferred embodiments of the present invention will be described so that a person having ordinary skill in the art to which the present invention pertains can easily practice the present invention.

[0024] <Example 1>

[0025] 3D scanning and printing process

[0026] 1. 3D scanning

[0027] 1) First, clean the surface of the user's nipple and areola area.

[0028] 2) Scan the nipple and areola area using a handheld 3D scanner. A 3D scanner is a device that measures even the smallest details of an object with high precision, producing 3D measurements. The user must remain still during this process. The scanned data is saved in STL file format.

[0029] 3) Import the saved STL file into 3D modeling software.

[0030] 4) The surface of the scan data is converted from a positive to a negative shape, and modified into a mold shape capable of casting silicon. Figure 1 (a) shows the scan data in a positive shape, and (b) is a drawing showing the shape of the mold converted to a negative shape.

[0031] 5) Prepare the final mold by cleaning the surface of the mold and adjusting the details as needed.

[0032] 2. 3D printing

[0033] 1) The modified 3D model is printed using a stereolithography (SLA) 3D printer. SLA, also known as liquid layer photopolymerization or resin 3D printing, is an additive manufacturing method that produces parts by curing a liquid resin into a hard plastic using a light source. SLA offers the highest resolution and accuracy of all 3D printing technologies, the finest details, and the smoothest surface finishes. The greatest advantage of SLA is its versatility. Material manufacturers have created innovative SLA photopolymer resin formulations with a wide range of optical, mechanical, and thermal properties, all of which match the properties of standard, engineering, and industrial thermoplastics. Resin 3D printing also allows for the use of a wide range of biocompatible materials.

[0034] 2) The surface of the mold printed with the SLA 3D printer is washed with alcohol, post-processed, and cured with UV.

[0035] Preparing for silicone casting

[0036] 1. Prepare the mold printed with an SLA 3D printer by coating it with a release agent to ensure that the silicone is easily separated.

[0037] 2. Silicone with a preset hardness (hardness 30), e.g., Mold Star TM20T and a hardener are mixed in a volume ratio of 1:1, and a silicone curing accelerator can be added here in a ratio of 1% to 4% based on the volume of the mixed solution. This is to shorten the curing time. In the above mixing process, the bottom and walls of the container into which the mixture is injected must be sufficiently stirred. Stir and mix for more than 2 minutes, and place in a vacuum deaerator to remove air bubbles. The mixed solution of silicone and hardener from which air bubbles have been removed is poured into a mold (negative mold) printed with the SLA 3D printer to produce a silicone mold. The silicone mold is formed to have a thickness of 2 to 3 cm. A circular guide can be formed on the edge of the area where the mixed solution is poured in the mold printed with the 3D printer.

[0038] 3. After that, let it dry naturally for 30 minutes or harden it in a 70 degree oven for 20 minutes.

[0039] 4. Once curing is complete, separate the silicone mold from the mold printed by the 3D printer.

[0040] 5. Additive silicone with very low viscosity and hardness, for example, additive silicone with hardness of 0.5 or less (ex. ECOFLEX) TM ) and the hardener are mixed in a 1:1 weight or volume ratio. At this time, mix thoroughly by stirring with a stick. For example, 20 g of additive silicone and 20 g of hardener can be mixed.

[0041] 6. Mix the pigments prepared during the additive silicone and hardener mixing process above. This allows for pigments to be mixed to match the user's skin tone. The pigments should be mixed at a maximum of 3% by volume or weight of the additive silicone and hardener mixture. The entire mixture can be vacuumed to remove air bubbles. Air bubble removal is essential for high-quality reproduction.

[0042] 7. Apply a thin layer of release agent, such as Vaseline, to the silicone mold. Apply heat using a dryer or similar device to melt the release agent.

[0043] 8. Apply a thin layer of release agent, such as Vaseline, to a separately prepared film. Apply heat using a dryer or similar device to melt the release agent and apply it.

[0044] 9. Pour the mixture obtained in steps 5 or 6 into the silicone mold. Pour slowly from the very bottom of the silicone mold. Also, pour in one spot to minimize air infiltration.

[0045] 10. Once the pouring process is complete, attach the film coated with the release agent. At this time, apply pressure to the attached film according to the thickness of the user's nipple and areola area to adjust the thickness and shape of the product. Because the viscosity and hardness of the additive-type silicone are low, it can easily be deformed by pressure.

[0046] 11. After 10-15 minutes of natural drying, clean up any silicone dripping from the surrounding area and place in a 60°C oven for approximately 20 minutes to cure. Alternatively, allow natural drying for approximately 4 hours.

[0047] 12. When curing is complete, separate the cured additive silicone, i.e. the silicone model, from the silicone mold.

[0048] 13. Wipe the surface of the silicone model attached to the film with 99% ethanol to remove silicone impurities.

[0049] Color mixing process

[0050] 14. The surface of the silicone model obtained in Step 13 is colored to match the user's nipple color. This process of coloring to match the nipple color is crucial for reproducing a realistic appearance, and the proportions of the colored pigments must be carefully adjusted to reflect the various tones of actual nipples.

[0051] 15. Mix the base pigment and hardener in a 1:1 volume ratio. The base pigment can be any well-known silicone pigment.

[0052] 16. To facilitate coloring or airbrushing, mix the base material and hardener with twice the volume of silicone thinner to reduce viscosity. For example, silicone thinner can be used.

[0053] 17. Additionally, pigments having additional colors can be additionally mixed into the solution after coloring.

[0054] 18. Use a brush to apply color in layers on the surface of the silicone model.

[0055] 19. For layering work, first, apply the first base coat (coloring) and then heat and dry in an 80 degree oven for 20 minutes.

[0056] 20. After that, the same process can be repeated for the 2nd, 3rd, …, Nth times.

[0057] 21. Preferably, coloring work can be performed up to four times to achieve the most realistic nipple and areola colors possible.

[0058] Matte work

[0059] 22. After coloring a silicone model, a matte finish can be applied to achieve a natural, moist gloss. During this process, a silicone polish (e.g., FS. MF-100 Clear) can be dissolved by adding an equal volume of silicone thinner.

[0060] 23. Once the solution is ready, apply it to the surface of the silicone model using a brush and let it cure naturally or leave it to cure. Then, repeat the same process a second time, but do not cure it this time.

[0061] 24. Apply a water-based powder (e.g. FS Matting Powder (Matting Power)) to the surface of the silicone model to remove the gloss of the painted silicone using a powder-specific brush.

[0062] 25. After that, let it dry naturally for about 24 hours.

[0063] 26. Wash the powder-treated silicone model with water. A matte finish is essential for a natural finish, and it's recommended to use powder after matte finishing to add a natural texture to the surface.

[0064] Body attachment method

[0065] 27. Mix silicone adhesive (e.g., EBA Silabond) and adhesion promoter (e.g., EBA Silabond Thinner) in a volume ratio of 10:1, apply the mixture to the lower surface of the silicone model obtained in step 34, and then attach it to the user's body. The adhesion promoter may shorten the bonding time.

[0066] How to remove

[0067] 28. The silicone model can be removed from the body by applying tension to the attached area.

[0068] 29. Wash the product and the body attachment area using a remover (e.g. EBA Vapore).

[0069] Meanwhile, according to another embodiment of the present invention, the following manufacturing method is also possible.

[0070] <Example 2>

[0071] 1. First, apply a thin layer of Vaseline (release agent) to the nipple and surrounding area of ​​the user's breast where the artificial nipple prosthesis will be attached (hereinafter referred to as the attachment area).

[0072] 2. Apply a curing solution (mixing a hardener, such as alginate, and water in a 1:1 volume ratio) to the attachment area. The lower the water temperature, the longer the curing time. This process improves the reproduction of detailed nipple and areola features. The application time is approximately 2 minutes, and the curing time is approximately 3 minutes.

[0073] 3. After mixing plaster and water, apply a plaster bandage soaked in the mixture to the hardening solution. Applying two layers of plaster bandages will ensure consistent results. The plaster bandage helps form a precise impression of the area by fixing the alginate.

[0074] 4. After the preset curing time (e.g. 2 minutes 30 seconds) has elapsed, the curing solution and plaster bandage will harden, and the cured plaster bandage and curing solution are removed.

[0075] At this time, applying heat can speed up the curing process.

[0076] 5. The hardened plaster bandage and the hardening solution may be integrated, forming a grooved or plate-shaped mold with the hardened solution applied to the upper surface. The liquefied clay is poured into this mold and allowed to cool. Clay, a type of sculpting agent, melts and liquefies at high temperatures. Therefore, the clay is heated, liquefied, and poured into the mold, where it is then allowed to cool.

[0077] 6. Separate the sufficiently cooled clay from the mold. This clay will serve as the basis for making a silicone mold.

[0078] 7. Attach the separated clay to the acrylic plate and apply a release agent to the upper surface of the clay.

[0079] 8. Create additional circular guides around the clay attached to the acrylic plate. These circular guides prevent the silicone from flowing outward, thereby maintaining the shape of the silicone mold to be manufactured. Furthermore, these circular guides prevent the silicone from drying out when used later.

[0080] 9. Silicone with a preset hardness (hardness 30), e.g., Mold Star TM20T and a hardener are mixed in a volume ratio of 1:1, and a silicone hardening accelerator can be added in a ratio of 1% to 4% based on the volume of the mixed solution. This is to shorten the curing time.

[0081] It is preferable that the above mixing process continue for more than 2 minutes, and air bubbles can be removed by placing it in a vacuum deaerator.

[0082] 10. Pour the mixture of silicone and hardener with the bubbles removed onto the clay model made in step 8 to create a silicone mold. The silicone mold should be 2 to 3 cm thick.

[0083] 11. Let the silicone-coated clay model and circular guide dry naturally for 30 minutes or harden in a 70 degree oven for 20 minutes.

[0084] 12. Once curing is complete, separate the silicone mold from the urethane model.

[0085] 13. 3D scanning of the obtained silicone mold as above can be performed and stored as a digital file.

[0086] The following process can be carried out in the same manner as process 5 described in the first embodiment.

[0087] An artificial nipple prosthesis according to one embodiment can reproduce the texture, color, and shape of a real nipple with great precision, and can achieve flexibility to be customized to the skin tone and texture of various individuals.

[0088] An artificial nipple prosthesis according to one embodiment provides a natural appearance and feel to the user, thereby providing psychological stability and confidence.

[0089] In one embodiment, because 3D scan data can be stored as a digital file, there is no need for storage space, it can be reused whenever needed, and because digital data is used, it becomes possible to manufacture precise prosthetics tailored to an individual's body.

[0090] Additionally, according to one embodiment, a method of making a silicone mold using alginate and then 3D scanning it can reduce initial costs while obtaining the advantage of digital data storage.

[0091] The foregoing description of the present invention is for illustrative purposes only, and those skilled in the art will readily appreciate that the present invention can be readily modified into other specific forms without altering the technical spirit or essential characteristics of the present invention. Therefore, the embodiments described above should be understood as illustrative in all respects and not restrictive. For example, each component described as a single entity may be implemented in a distributed manner, and similarly, components described as distributed may be implemented in a combined manner.

[0092] The scope of the present invention is indicated by the claims described below, and all changes or modifications derived from the meaning and scope of the claims and their equivalent concepts should be interpreted as being included in the scope of the present invention.

Claims

1. A method for manufacturing an artificial nipple prosthesis, A step of performing a scan of the nipple and areola area of ​​the body using 3D scanning and converting the surface of the scan data from positive to negative; A step of obtaining a printing mold by performing 3D printing based on scan data converted into negative; A step of manufacturing a silicone mold by applying silicone to the above printing mold; A step of separating the above silicone mold from the printing mold, pouring additional silicone into the silicone mold, and curing it; and A method for manufacturing an artificial nipple prosthesis, comprising the step of separating the cured additional silicone from the silicone mold to obtain a silicone model.

2. In paragraph 1, The step of pouring additional silicone into the above silicone mold and curing it is as follows: A step of attaching a film coated with a release agent after pouring the additional silicone; and A method for manufacturing an artificial nipple prosthesis, comprising a step of applying pressure to a film to control the thickness and shape of the product.

3. In paragraph 1 A method for manufacturing an artificial nipple prosthesis, further comprising a step of performing coloring through layering work on the surface of the silicone model.

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