Preparation method of 3D printing artificial breast

Abstract

The invention discloses a preparation method of a 3D printing artificial breast. The preparation method comprises the following steps: S1, determining a pigment, wherein the step is mainly used for determining the color of a TPE natural color material; according to the preparation method of the 3D printed artificial breast, a novel artificial breast preparation method is realized, 3D printing of a pure TPE material is realized, and color, size, shape and fragrance can be selected by a patient, so that personalized customization of the artificial breast is realized, and the aesthetic requirement of bilateral symmetry of the breast appearance of the patient is met; meanwhile, the problem that traditional artificial breasts are produced according to numbers and have no appropriate sizes for patients with too small and too large breasts is solved, the problem of water storage of breathable micropores can be effectively solved through the hydrophobic characteristic of materials, ventilation and breathability can be effectively achieved in daily wearing, sweat retention is avoided, application scenes such as hot spring and swimming can be expanded, and the artificial breasts are worthy of popularization and application. And the living quality of the user is greatly improved.

Description

Technical Field

[0001] The present invention relates to the field of biomedical technology, and in particular to a method for preparing a 3D printed breast prosthesis. Background Art

[0002] Most breast cancer patients need to undergo surgical treatment of mastectomy, which is usually accompanied by unilateral or bilateral breast loss after surgery. This tissue loss poses challenges to the patient's appearance and psychology. In particular, the change in appearance often brings inconvenience to the patient during the process of returning to social life after surgery and affects the quality of life after surgery. At this time, a 3D printed breast prosthesis preparation method can be used to provide breast prosthesis preparation for breast cancer patients.

[0003] The existing breast prosthesis preparation processes on the market have the following problems when applied: Traditional breast prosthesis preparation methods usually adopt implantation or external breast prosthesis. Implantation is to fill autologous fat or implant prosthesis through surgery. This type of scheme is often accompanied by capsular contracture caused by postoperative rejection, filling failure, etc., and is not a lifelong solution. Generally, surgery is required again in about ten years. External breast prosthesis is to place cotton, silicone and other materials in underwear to maintain the appearance. However, due to limited material selection and outdated production concepts, traditional breast prostheses are often accompanied by problems such as chest wall wound infection and lack of suitable size for patients. Summary of the Invention

[0004] In view of the deficiencies in the background technology, the present invention provides a method for preparing a 3D printed breast prosthesis.

[0005] In order to solve the above-mentioned problem, the present invention adopts the following technical solution, a method for preparing a 3D printed breast prosthesis, characterized in that the preparation steps include the following:

[0006] S1, determine the color: This step is mainly to determine the color of the TPE color material;

[0007] S2, prepare fragrance masterbatch: TPE fragrance masterbatch is an additive used to impart fragrance to TPE materials. The main components of TPE fragrance masterbatch include fragrance, carrier, and additives. Fragrance is the core component that provides fragrance;

[0008] S3, purchase color powder: purchase the required color powder on the market. The color powder used is a special color powder for TPE elastomer raw materials, which is a colorant designed specifically for TPE materials;

[0009] S4, Proportion Test: Add color powder to a small batch of original color material to check whether the final color is close to the selected Pantone color number;

[0010] S5, finished product analysis: analysis of the hardness and melting point of the finished product;

[0011] S6, finished product preparation: prepare finished products using finished materials.

[0012] As a further preferred embodiment of the present invention, in step S1, the patient is allowed to freely select a favorite color according to preference, and the color is determined as the color of the finished breast prosthesis.

[0013] As a further preferred embodiment of the present invention, in step S2, part of the original color material is mailed to the manufacturer, and TPE fragrance masterbatch is prepared through the manufacturer's process. TPE fragrance masterbatch is an additive for giving fragrance to TPE materials. Its main components include flavor, carrier and adjuvant. The flavor is the core component for providing fragrance, the carrier is used to disperse and fix the flavor, and the adjuvant helps to improve the stability and durability of the fragrance, so that the flavor is fully integrated with the TPE original color material of our product. There are floral and fruity flavors, among which floral flavors include jasmine, osmanthus, rose, gardenia and white magnolia, and fruity flavors include apple, lemon, strawberry and peach, and other mature flavors such as lavender and vanilla. This type of flavor can be selected by patients.

[0014] As a further preferred embodiment of the present invention, in step S3, color powder is purchased as needed. Since the special color powder for TPE elastomer raw materials is a colorant specially designed for TPE materials, it gives the material a specific color by mixing with the TPE substrate. These color powders have excellent dispersibility, high temperature resistance, migration resistance and weather resistance, and can meet the requirements of different TPE products for color stability and aesthetics. Giving the material a specific color by color powder can provide color choices for patients.

[0015] As a further preferred embodiment of the present invention, in step S4, a ratio test is performed for the color powder, TPE flavor masterbatch and TPE original color material. When performing the ratio test, the desired color and flavor TPE finished material is produced by heating and melting, and the color powder is added to the original color material in small batches to check whether the final color is close to the selected Pantone color number. At the same time, the optimal formula ratio is recorded, and then the color is tested by a common method to see whether it is easy to fall off. In multiple tests, the equipment needs to be cleaned before the test. The food contact material supervision GB480 is used for the ratio. 6 series of standards, and the test is carried out in this standard. The test contents mainly include evaporation residue in different food simulation liquids, potassium permanganate consumption, heavy metals, decolorization test, heavy metal dissolution test, toxic and harmful monomer residues and microbial detection. For the evaporation residue in different food simulation liquids, distilled water, alcohol, acetic acid and other simulation liquids can be used to extract TPE samples, and the evaporation residue content in the extract can be measured. The potassium permanganate consumption is evaluated by potassium permanganate titration to evaluate the oxidation performance of TPE materials under specific conditions. The heavy metals in TPE materials are measured. The heavy metal content, especially lead, is evaluated in the decolorization test to ensure that it meets safety standards. The color stability of TPE materials under specific conditions is evaluated. The heavy metal dissolution test includes the dissolution test of various heavy metal elements such as lead, cadmium, arsenic, chromium, nickel, etc. The residual amount of toxic and harmful monomers such as vinyl chloride monomer and acrylonitrile monomer is tested. The microbial contamination of TPE materials during production and use is evaluated in the microbial test. The twin-screw extruder directly heats the TPE raw materials, mixes, plasticizes and extrude the TPE raw materials, specifically First, the raw material processing temperature is raised to 170°C, and then color powder is added in proportion. The machine equipment then stirs and mixes the TPE raw materials for 30 minutes to ensure that the melt temperature is maintained between 160-170°C during this period. Stirring can evenly distribute the raw materials in the heating equipment to avoid local overheating. Mixing can mix TPE raw materials of different brands to improve the overall performance of the product. After the TPE product is processed, it needs to be annealed to help eliminate residual stress inside the material and improve the dimensional stability of the material. Finally, the material can be granulated.

[0016] As a further preferred embodiment of the present invention, in step S5, the finished material left in the proportioning test is then analyzed to analyze the changes in the hardness and hot melting point of the finished material. Due to the addition of color powder and flavor, the change in proportion will lead to changes in the material properties. Before 3D printing, it is necessary to measure the key properties of the above two materials. When analyzing the hardness in this step, a Shore hardness tester can be used, and when analyzing the hot melting point, a melt index meter can be used.

[0017] As a further preferred embodiment of the present invention, in step S6, the finished material is finally prepared. During the preparation, the finished material is directly added to the printer for 3D printing until the finished product is printed. During printing, the TPE material can be first heated and melted by the machine, and then tiny plastic droplets are sprayed out by pressing the nozzle switch. The droplets fall at different positions of the printing chamber as the nozzle moves, automatically cool and solidify, and are stacked to form a three-dimensional structure.

[0018] The present invention realizes a novel method for preparing prosthetic breasts through a 3D printed prosthetic breast preparation method. By realizing 3D printing of pure TPE material and providing patients with choices in color, size, shape and fragrance, personalized customization of prosthetic breasts is achieved, meeting the patient's aesthetic demand for bilateral symmetry in breast appearance, and making up for the problem that traditional prosthetic breasts are produced according to numbers and there is no suitable size for patients with too small or too large breasts. In addition, the material uses medical-grade TPE material, supports cleaning with conventional laundry detergents, and is resistant to ultraviolet rays, which can effectively avoid problems such as wound allergies and infections caused by aging of the material due to ultraviolet rays. At the same time, the hydrophobic properties of the material can effectively solve the problem of breathable microporous water storage, and can effectively achieve ventilation and air permeability during daily wear to avoid sweat retention. It can also expand application scenarios such as hot springs and swimming, greatly improving the quality of life of users. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a schematic diagram of the overall structure of the present invention; DETAILED DESCRIPTION

[0020] Hereinafter, only certain exemplary embodiments are briefly described. As will be appreciated by those skilled in the art, the described embodiments may be modified in various ways without departing from the spirit or scope of the present invention. Therefore, the drawings and description are to be considered as illustrative in nature and not restrictive.

[0021] In the description of the present invention, it should be understood that the terms "length", "vertical", "horizontal", "top", "bottom", etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they cannot be understood as limitations on the present invention.

[0022] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature identified as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, "plurality" means two or more, unless otherwise specifically defined.

[0023] In the present invention, unless otherwise expressly specified or limited, terms such as "mounted," "connected," "connect," and "fixed" should be understood broadly. For example, they may refer to fixed connection, detachable connection, or integration; mechanical connection, electrical connection, or communication; direct connection or indirect connection through an intermediate medium; and internal communication between two components or interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0024] The following disclosure provides many different embodiments or examples for implementing different structures of the present invention. To simplify the disclosure of the present invention, the components and configurations of specific examples are described below. Of course, these are merely examples and are not intended to limit the present invention. In addition, the present invention may repeat reference numbers and / or reference letters in different examples. Such repetition is for the purpose of simplicity and clarity and does not in itself indicate the relationship between the various embodiments and / or configurations discussed.

[0025] The present invention provides a technical solution: a method for preparing a 3D printed breast prosthesis, the preparation steps comprising the following:

[0026] Example 1

[0027] Determine the color: This step is mainly to determine the color of the TPE color.

[0028] The patient is allowed to freely choose a favorite color according to preference, and the color is determined as the color of the finished breast prosthesis.

[0029] The benefits of identifying colorants allow patients to choose their own favorite colors, which can increase patient preference.

[0030] Example 2

[0031] Preparation of fragrance masterbatch: TPE fragrance masterbatch is an additive used to impart fragrance to TPE materials. The main components of TPE fragrance masterbatch include fragrance, carrier, and additives. Fragrance is the core ingredient that provides fragrance.

[0032] Part of the original color material is mailed to the manufacturer and TPE fragrance masterbatch is prepared through the manufacturer's process. TPE fragrance masterbatch is an additive used to give TPE materials fragrance. Its main ingredients include flavor, carrier and additives. Flavor is the core ingredient for providing fragrance, carrier is used to disperse and fix the flavor, and additives help improve the stability and durability of the fragrance, so that the flavor is fully integrated with the TPE original color material of our product. There are floral and fruity scents, among which floral scents include jasmine, osmanthus, rose, gardenia and white magnolia, and fruity scents include apple, lemon, strawberry and peach. Other mature flavors such as lavender and vanilla are available for patients to choose.

[0033] The benefit of preparing fragrance masterbatches is that patients can choose their favorite flavors, while additives can help improve the stability and durability of the fragrance.

[0034] Example 3

[0035] Purchasing color powder: Purchase the required color powder on the market. The color powder used is a special color powder for TPE elastomer raw materials, which is a colorant designed specifically for TPE materials.

[0036] After that, color powder will be purchased as needed. The special color powder for TPE elastomer raw materials is a colorant designed specifically for TPE materials. It gives the material a specific color by mixing with the TPE substrate. These color powders have excellent dispersibility, high temperature resistance, migration resistance and weather resistance, and can meet the color stability and aesthetic requirements of different TPE products. Giving the material a specific color by color powder can provide patients with color choices.

[0037] The benefits of purchasing color powder are that it has excellent dispersibility, high temperature resistance, migration resistance and weather resistance. At the same time, it can meet the color stability and aesthetic requirements of different TPE products. By giving the material a specific color through color powder, patients can provide color choices.

[0038] Example 4

[0039] Ratio test: Add color powder to a small batch of original color material to check whether the final color is close to the selected Pantone color number.

[0040] The color powder, TPE fragrance masterbatch and TPE original color material were tested for the ratio. During the ratio test, the desired color and fragrance TPE finished material was produced by heating and melting, and the color powder was added to a small batch of original color material to check whether the final color was close to the selected Pantone color number. At the same time, the optimal formula ratio was recorded. The color was then tested by common methods to see if it was easy to fall off. In multiple tests, the equipment needed to be cleaned before the test. The GB4806 series of standards for food contact materials were used for the ratio test and the test was carried out according to this standard. The test contents mainly included evaporation residue in different food simulants, potassium permanganate consumption, heavy metals, decolorization test, heavy metal dissolution test, toxic and harmful monomer residues and microbial detection. For the evaporation residue in different food simulants, the TPE samples could be extracted with simulants such as distilled water, alcohol, and acetic acid, and the evaporation residue content in the extract was measured. The potassium permanganate consumption was evaluated by potassium permanganate titration to evaluate the oxidation performance of the TPE material under specific conditions. The heavy metal content in the TPE material was measured, especially Lead is tested to ensure it meets safety standards. The discoloration test evaluates the color stability of TPE materials under specific conditions. The heavy metal dissolution test includes the dissolution amount of various heavy metal elements such as lead, cadmium, arsenic, chromium, and nickel. The residual amount of toxic and hazardous monomers, such as vinyl chloride monomer and acrylonitrile monomer, is tested. The microbial test evaluates the microbial contamination of TPE materials during production and use. The twin-screw extruder directly heats the TPE raw materials, mixes, plasticizes and extrudes the TPE raw materials. Specifically, the raw materials are first processed to a temperature of 170°C, and then the color powder is added in proportion. The machine equipment then stirs and mixes the TPE raw materials for 30 minutes, ensuring that the melt temperature is maintained between 160-170°C during this period. Stirring can evenly distribute the raw materials in the heating equipment to avoid local overheating. Mixing can be used to mix TPE raw materials of different grades to improve the overall performance of the product. After processing, the TPE product needs to be annealed to help eliminate residual stress within the material and improve the material's dimensional stability. Finally, the material is pelletized.

[0041] The benefit of ratio testing is that through ratio testing, TPE finished products with the required color and fragrance can be obtained, and the quality of TPE finished products can be guaranteed to meet safety standards.

[0042] Example 5

[0043] Finished product analysis: Analyze the changes in hardness and melting point of finished products.

[0044] After that, the finished material left in the proportion test is analyzed to analyze the changes in the hardness and hot melting point of the finished material. Due to the addition of color powder and flavor, the change in proportion will lead to changes in the material properties. Before 3D printing, the key characteristics of the above two materials need to be measured. In this step, when analyzing the hardness, a Shore hardness tester can be used, and when analyzing the hot melting point, a melt index meter can be used.

[0045] The benefit of finished product analysis is that hardness and melting point data of different finished products can be obtained through hardness and melting point tests.

[0046]

[0047]

[0048] Example 6

[0049] Finished product preparation: Finished products are prepared through finished materials.

[0050] Finally, the finished material is directly added to the printer for 3D printing until the finished product is printed. During printing, the TPE material can be first heated and melted by the machine, and then tiny plastic droplets are sprayed out by pressing the nozzle switch. The droplets fall at different positions of the printing chamber as the nozzle moves, automatically cool and solidify, and are stacked layer by layer to form a three-dimensional structure.

[0051] The benefit of finished product preparation is that by adding the finished material to the printer for 3D printing, the required size and shape of the prosthesis can be printed as needed.

[0052] In summary, the present invention realizes a novel method for preparing prosthetic breasts through a 3D printed prosthetic breast preparation method. By realizing 3D printing of pure TPE material and providing patients with choices in color, size, shape and fragrance, personalized customization of prosthetic breasts is achieved, meeting the patient's aesthetic needs for bilateral symmetry in breast appearance, and at the same time making up for the problem that traditional prosthetic breasts are produced according to numbers and there is no suitable size for patients with too small or too large breasts. In addition, the material uses medical-grade TPE material, supports cleaning with conventional laundry detergents, and is resistant to ultraviolet rays, which can effectively avoid problems such as wound allergies and infections caused by aging of the material due to ultraviolet rays. At the same time, the hydrophobic properties of the material can effectively solve the problem of breathable microporous water storage, and can effectively achieve ventilation and breathability during daily wear to avoid sweat retention. It can also expand application scenarios such as hot springs, swimming, etc., greatly improving the quality of life of users.

[0053] The above shows and describes the basic principles and main features of the present invention and the advantages of the present invention. It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above and that the present invention can be implemented in other specific forms without departing from the spirit or essential characteristics of the present invention. Therefore, from all perspectives, the embodiments should be regarded as illustrative and non-restrictive. The scope of the present invention is defined by the appended claims, not the foregoing description, and it is intended that all variations that come within the meaning and range of equivalents of the claims be included within the present invention. Any reference signs in the claims should not be construed as limiting the claim to which they relate.

[0054] In addition, it should be understood that although this specification is described in terms of implementation methods, not every implementation method contains only one independent technical solution. This narrative method of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment can also be appropriately combined to form other implementation methods that can be understood by those skilled in the art.

Claims

1. A method for preparing a 3D printed breast prosthesis, characterized in that: The preparation steps include the following: S1, determine the color: This step is mainly to determine the color of the TPE color material; S2, prepare fragrance masterbatch: TPE fragrance masterbatch is an additive used to impart fragrance to TPE materials. The main components of TPE fragrance masterbatch include fragrance, carrier, and additives. Fragrance is the core component that provides fragrance; S3, purchase color powder: purchase the required color powder on the market. The color powder used is a special color powder for TPE elastomer raw materials, which is a colorant designed specifically for TPE materials; S4, Proportion Test: Add color powder to a small batch of original color material to check whether the final color is close to the selected Pantone color number; S5, finished product analysis: analysis of the hardness and melting point of the finished product; S6, finished product preparation: prepare finished products using finished materials.

2. The method for preparing a 3D printed breast prosthesis according to claim 1, wherein: In step S1, the patient is allowed to freely select a favorite color according to preference, and the color is determined as the color of the finished breast prosthesis.

3. The method for preparing a 3D printed breast prosthesis according to claim 1, wherein: In step S2, part of the original color material is mailed to the manufacturer, and TPE fragrance masterbatch is prepared through the manufacturer's process. TPE fragrance masterbatch is an additive used to give TPE materials fragrance. Its main components include flavor, carrier and auxiliary agent. The flavor is the core component that provides fragrance, the carrier is used to disperse and fix the flavor, and the auxiliary agent helps to improve the stability and durability of the fragrance, so that the flavor is fully integrated with the TPE original color material of our product. There are floral and fruity fragrances, among which floral fragrances include jasmine, osmanthus, rose, gardenia and white magnolia, and fruity fragrances include apple, lemon, strawberry and peach. Other mature flavors such as lavender and vanilla are available for patients to choose.

4. The method for preparing a 3D printed breast prosthesis according to claim 1, wherein: In step S3, color powder is then purchased as needed. The special color powder for TPE elastomer raw materials is a colorant designed specifically for TPE materials. It gives the material a specific color by mixing with the TPE substrate. These color powders have excellent dispersibility, high temperature resistance, migration resistance and weather resistance, and can meet the color stability and aesthetic requirements of different TPE products. Giving the material a specific color by color powder can provide color choices for patients.

5. The method for preparing a 3D printed breast prosthesis according to claim 1, wherein: In step S4, a ratio test is performed on the color powder, TPE fragrance masterbatch and TPE original color material. During the ratio test, the required color and fragrance TPE finished material is produced by heating and melting, and the color powder is added to the original color material in small batches to check whether the final color is close to the selected Pantone color number. At the same time, the optimal formula ratio is recorded, and then the color is tested by common methods to see whether it is easy to fall off. In multiple tests, the equipment needs to be cleaned before the test.

6. The method for preparing a 3D printed breast prosthesis according to claim 1, wherein: In step S5, the finished material left over from the proportioning test is then analyzed to determine changes in hardness and melting point. Changes in the proportions of color powder and flavoring will lead to changes in material properties. Prior to 3D printing, the key properties of the two materials must be measured.

7. The method for preparing a 3D printed breast prosthesis according to claim 1, wherein: In step S6, the finished material is finally prepared. During the preparation, the finished material is directly added to the printer for 3D printing until the finished product is printed. During printing, the TPE material can be first heated and melted by the machine, and then tiny plastic droplets are sprayed out by pressing the nozzle switch. The droplets fall at different positions of the printing chamber as the nozzle moves, automatically cool and solidify, and are stacked to form a three-dimensional structure.

8. The method for preparing a 3D printed breast prosthesis according to claim 1, wherein: In step S4, the GB4806 series of standards for the supervision of food contact materials are used for proportioning, and tests are conducted according to this standard. The test contents mainly include evaporation residue in different food simulants, potassium permanganate consumption, heavy metals, decolorization test, heavy metal dissolution test, toxic and harmful monomer residues and microbial detection. For the evaporation residue in different food simulants, the TPE sample can be extracted with simulant liquids such as distilled water, alcohol, acetic acid, etc., and the evaporation residue content in the extract can be measured. The potassium permanganate consumption is evaluated by potassium permanganate titration to evaluate the oxidation performance of the TPE material under specific conditions. The heavy metal content in the TPE material, especially lead, is measured to ensure that it meets safety standards. The decolorization test evaluates the color stability of the TPE material under specific conditions. The heavy metal dissolution test includes the dissolution amount test of various heavy metal elements such as lead, cadmium, arsenic, chromium, nickel, etc. The residual amount of toxic and harmful monomers such as vinyl chloride monomer and acrylonitrile monomer is tested. The microbial contamination of the TPE material during production and use is evaluated in the microbial test.

9. The method for preparing a 3D printed breast prosthesis according to claim 1, wherein: In step S4, a direct heating method can be selected in this step. The TPE raw material is directly heated by a twin-screw extruder, and the TPE raw material is mixed, plasticized and extruded. Specifically, the raw material processing temperature is first raised to 170°C, and then the color powder is added in proportion. After that, the machine equipment stirs and mixes the TPE raw material for 30 minutes to ensure that the melt temperature during this period is maintained between 160-170°C. Stirring can evenly distribute the raw material in the heating equipment to avoid local overheating. Mixing can mix TPE raw materials of different brands to improve the comprehensive performance of the product. After the TPE product is processed, it needs to be annealed and post-treated to help eliminate the residual stress inside the material and improve the dimensional stability of the material. Finally, the material can be granulated.

10. The method for preparing a 3D printed breast prosthesis according to claim 1, wherein: In step S5, when analyzing the hardness, a Shore durometer may be used, and when analyzing the melting point, a melt indexer may be used.

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