Preparation method of silica gel artificial breast

Abstract

The invention discloses a manufacturing method of a silica gel artificial breast, the silica gel artificial breast comprises a phase change layer located in the middle, and a first silica gel layer and a second silica gel layer located at two sides of the phase change layer, the phase change layer is filled with a phase change material, and the phase change material is phase change energy storage microspheres; the manufacturing method comprises the following steps: preparing a polymer plastic bag with three cavities, wherein a plastic injection port is correspondingly reserved in each cavity; silica gel is injected into the cavities corresponding to the first silica gel layer and the second silica gel layer through the gel injection openings respectively, and sealing is conducted correspondingly; gas is injected into a cavity corresponding to the phase change layer through a glue injection port, and then sealing is conducted; heating, curing and forming the intermediate product which is provided with the first silica gel layer and the second silica gel layer and is filled with gas in the phase change layer; shearing a glue injection opening of a phase change layer of a molded product, and injecting phase change energy storage microspheres; and sealing to obtain the silica gel prosthesis with the phase change energy storage function.

Description

[0001] This application is a divisional application of the invention patent application with application date of November 15, 2017, application number 2017111263875, and invention name "A silicone breast prosthesis with phase change energy storage function and its manufacturing method". Technical Field

[0002] The invention relates to the technical field of breast prosthesis manufacturing, which is applied to the medical industry, such as external repair of human body, and in particular to a method for manufacturing a silicone breast prosthesis with phase change energy storage function. Background Art

[0003] Many breast cancer patients need to wear prosthetic breasts to maintain a normal body shape in their daily lives after mastectomy.

[0004] There are several types of silicone breast prostheses on the market: (1) ordinary silicone gel breast prostheses; (2) ordinary lightweight silicone breast prostheses; (3) multi-layer functional breast prostheses; (4) non-film-coated foam silicone breast prostheses. Although the above-mentioned breast prostheses can perfectly present the appearance of real breasts, they all have the following obvious defects: (1) Ordinary silicone gel breast prostheses have a large specific gravity, which is heavy for patients to wear and is not suitable for long-term wear; (2) Although ordinary lightweight silicone breast prostheses have a specific gravity adjusted to suit the specific gravity of human fat tissue, when worn for a long time, the body's heat cannot be released from the body, and long-term wearing will make people feel very stuffy; (3) Multi-layer breast prostheses have only a single specific function. In addition, non-film-coated foam breast prostheses also have many small holes. After long-term use, the dirt in the holes cannot be cleaned, which is harmful to the human body. Summary of the invention

[0005] In view of this, in order to overcome the defects of the prior art, one of the purposes of the present invention is to provide a silicone breast prosthesis with phase change energy storage function, which has good air permeability, good support, automatic heat absorption and heat release, and is more comfortable and more humane to wear.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions:

[0007] A silicone breast prosthesis with phase change energy storage function, including a phase change layer in the middle and a first silicone layer and a second silicone layer on both sides of the phase change layer, wherein the phase change layer is filled with a phase change material. The full name of phase change material in English is Phase Change Materials, referred to as PCM. It refers to a type of substance that uses the phase or structural changes of the material itself within a certain temperature range to automatically absorb or release latent heat to the environment, thereby achieving the purpose of regulating the ambient temperature. The specific phase change process is: when the ambient temperature is higher than the phase change temperature, the material absorbs and stores heat to lower the ambient temperature; when the ambient temperature is lower than the phase change temperature, the material releases the stored heat to increase the ambient temperature.

[0008] Preferably, the phase change material is phase change energy storage microspheres.

[0009] More preferably, the phase change temperature of the phase change energy storage microsphere is 32-37°C. The phase change temperature of the selected phase change energy storage microsphere is 32-37°C, which is adapted to the human body temperature. When the human body temperature is higher than this temperature, the phase change energy storage microsphere begins to absorb heat energy and store it; when the human body temperature is lower than this temperature, the phase change energy storage microsphere begins to release the stored heat energy, so that the user will not feel stuffy when wearing it in summer, and the silicone breast prosthesis can be properly heated in winter to provide a certain amount of heat to the human body when the weather is cold, making it more comfortable and more humane to wear.

[0010] Preferably, the first silicone layer is filled with a first silicone gel, and the second silicone layer is filled with a second silicone gel; the specific gravity of the first silicone gel is less than the specific gravity of the second silicone gel. The combination of silicone gels of different specific gravities allows the weight of the silicone breast prosthesis to be controlled within an appropriate range, making it more comfortable to wear and having a better support effect.

[0011] More preferably, the specific gravity of the first silicone gel is 0.6-0.7 g / cm 3 The specific gravity of the second silicone gel is 0.9-1.1 g / cm 3 .

[0012] Preferably, the second silicone layer has a convex portion on a side away from the phase change layer, and guide grooves are formed between adjacent convex portions, so that the heat energy of the human body can be discharged from the body better, effectively ensuring that the gas on the body-contacting surface can pass through smoothly, so that the silicone breast prosthesis has good ventilation function.

[0013] Another object of the present invention is to provide a method for making the silicone breast prosthesis with phase change energy storage function as described above, comprising the following steps:

[0014] 1) Preparation of polymer plastic bag: four polymer films are pressed together to form a polymer plastic bag having three cavities for accommodating a phase change layer, a first silicone layer and a second silicone layer, and a corresponding injection port is left for each cavity;

[0015] 2) Preparing a silicone layer: injecting the prepared first silicone gel into the cavity corresponding to the first silicone layer through the injection port, injecting the prepared second silicone gel into the cavity corresponding to the second silicone layer, and sealing them accordingly;

[0016] 3) Gas injection and sealing: injecting gas into the cavity corresponding to the phase change layer through the glue injection port and then sealing;

[0017] 4) Heating and molding: heating and curing the intermediate product obtained in step 3) having the first silicone layer, the second silicone layer and the phase change layer filled with gas;

[0018] 5) Injection of phase change material: Cut the injection port of the phase change layer of the molded product and inject phase change energy storage microspheres;

[0019] 6) Sealing: Clean the injection port after injecting the phase change energy storage microspheres, and seal it to obtain a silicone breast prosthesis with phase change energy storage function.

[0020] Preferably, the heating molding process is performed at a temperature of 80-100° C. and a curing time of 30-40 minutes.

[0021] Preferably, the operation of step 3) gas injection and sealing is specifically as follows: a release film is placed in the injection port of the cavity corresponding to the phase change layer, and gas is injected into the cavity. After the injection is completed, the release film is sealed, and after sealing, it is sealed again 8-12mm outside the injection port.

[0022] Preferably, the volume of the gas injected in step 3) is the same as the volume of the phase change energy storage microspheres injected in step 5).

[0023] Due to the adoption of the above technical solution, compared with the prior art, the present invention is beneficial in that:

[0024] 1. The silicone layer of the silicone breast prosthesis with phase change energy storage function of the present invention comprises a first silicone layer using light silicone gel located on the outside and a second silicone layer using silicone gel with a larger specific gravity located on the inside. The silicone gels with different specific gravities are used in combination, so that the weight of the silicone breast prosthesis is controlled within an appropriate range, making it more comfortable to wear and having a better supporting effect;

[0025] 2. The silicone breast prosthesis with phase change energy storage function of the present invention is designed with corresponding convex parts according to the shape of the breast prosthesis product and the human body shape, and a guide groove is formed between adjacent convex parts, so that the heat energy of the human body can be discharged from the body better, and the gas on the close-fitting surface can be effectively ensured to be unobstructed, so that the silicone breast prosthesis has good air permeability;

[0026] 3. In order to better improve the performance of phase change energy storage, the silicone breast prosthesis with phase change energy storage function of the present invention is designed with a separate cavity to accommodate phase change energy storage microspheres, allowing the microspheres to move in an independent space, so that the heat absorption and heat dissipation are more uniform;

[0027] 4. The phase change temperature of the phase change energy storage microspheres used in the silicone breast prosthesis with phase change energy storage function of the present invention is 32-37°C, which is adapted to the human body temperature. When the human body temperature is higher than this temperature, the phase change energy storage microspheres begin to absorb heat energy and store it; when the human body temperature is lower than this temperature, the phase change energy storage microspheres begin to release the stored heat energy, so that the user will not feel stuffy when wearing it in summer, and the silicone breast prosthesis can be properly heated in winter to provide a certain amount of heat to the human body when the weather is cold, making it more comfortable and more humane to wear;

[0028] 5. In order to ensure that the performance of the phase-change energy storage microspheres will not decay due to high-temperature molding of the product, the silicone breast prosthesis with phase-change energy storage function of the present invention adopts the method of injecting an equal volume of gas to replace the phase-change energy storage microspheres when the intermediate product is heated and cured, and then opening the injection port to inject the phase-change energy storage microspheres into the corresponding cavity after the heating and molding is completed, thereby ensuring the performance of the phase-change energy storage microspheres;

[0029] 6. The method for making a silicone breast prosthesis with phase change energy storage function of the present invention is to place a release film in the cavity injection port corresponding to the phase change layer, first seal the release film, and then seal again outside the release film, and when waiting to inject phase change energy storage microspheres, cut off the external seal, take out the release film, and seal the injection port after injecting the phase change energy storage microspheres. This process can simplify the steps of secondary injection and save production costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 A cross-sectional view of a silicone breast prosthesis with phase change energy storage function according to an embodiment of the present invention;

[0031] Among them: a first silicone layer-1, a second silicone layer-2, a phase change layer-3, a convex portion-4, a guide groove-5, and a polymer film-6. DETAILED DESCRIPTION

[0032] The preferred embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0033] See attached Figure 1The silicone breast prosthesis with phase change energy storage function of this embodiment includes a phase change layer 3 in the middle and a first silicone layer 1 and a second silicone layer 2 on both sides of the phase change layer 3. When worn, the first silicone layer 1 is away from the human body, and the second silicone layer 2 is close to the human body.

[0034] The phase change layer 3 is filled with phase change material. The phase change material in this embodiment is phase change energy storage microspheres. The phase change temperature of the phase change energy storage microspheres is 32-37°C, and 35°C is selected in this embodiment. The phase change temperature of the selected phase change energy storage microspheres is adapted to the human body temperature. When the human body temperature is higher than this temperature, the phase change energy storage microspheres begin to absorb heat energy and store it; when the human body temperature is lower than this temperature, the phase change energy storage microspheres begin to release the stored heat energy, so that the user will not feel stuffy when wearing it in summer. In winter, the silicone breast prosthesis can be properly heated to provide a certain amount of heat to the human body when the weather is cold, making it more comfortable and more humane to wear.

[0035] The first silicone layer 1 is filled with a first silicone gel, and the second silicone layer 2 is filled with a second silicone gel; the specific gravity of the first silicone gel is less than that of the second silicone gel. The specific gravity of the first silicone gel is 0.6-0.7 g / cm 3 The specific gravity of the second silicone gel is 0.9-1.1g / cm 3 In this embodiment, the specific gravity of the first silicone gel is 0.65 g / cm 3 The specific gravity of the second silicone gel is 0.98g / cm 3 The combination of silicone gels with different specific gravities can control the weight of silicone breast prostheses within an appropriate range, making them more comfortable to wear and providing better support.

[0036] The second silicone layer 2 has a convex portion 4 on the side away from the phase change layer 3, and a guide groove 5 is formed between adjacent convex portions 4, so that the heat energy of the human body can be discharged from the body better, effectively ensuring that the gas on the body-contacting surface can be unobstructedly penetrated, so that the silicone breast prosthesis has a good ventilation function.

[0037] This embodiment also provides a method for making the silicone breast prosthesis with phase change energy storage function as described above, which specifically includes the following steps:

[0038] Step S1: Open the molding mold

[0039] According to the design of silicone breast prosthesis, a set of heating molding molds suitable for breast prosthesis is developed.

[0040] Step S2: Preparation of polymer plastic bag

[0041] According to the design form of silicone breast prosthesis products, three sets of edge sealing molds are developed to press four polymer films to form a polymer bag with three cavities for accommodating the phase change layer 3, the first silicone layer 1 and the second silicone layer 2. Each cavity has a glue injection port at a designated position. The polymer film can be a polyurethane film.

[0042] Step S3: Silicone gel preparation

[0043] According to the design of silicone breast prosthesis products, the silicone gel material required for the product is prepared according to the regulations, and after the preparation is completed, the colloid vacuum degassing treatment is performed. In this embodiment, the specific gravity of the first silicone gel is selected to be 0.65g / cm 3 The specific gravity of the second silicone gel is 0.98g / cm 3 .

[0044] Step S4: Glue injection and exhaust

[0045] The prepared gel material is injected into the designated cavity according to the weight of the product design, that is, the first silicone gel is injected into the cavity corresponding to the first silicone layer 1, and the second silicone gel is injected into the cavity corresponding to the second silicone layer 2, and the gas in the cavity is exhausted.

[0046] Step S5: Sealing

[0047] The injection ports of the first silicone layer 1 and the second silicone layer 2 corresponding to the cavities are sealed with a hot melt machine.

[0048] Step S6: Gas injection and sealing

[0049] Put a release film in the injection port of the cavity corresponding to the phase change layer 3, and then inject gas into the cavity. After the injection is completed, seal the release film, and then seal again 8-12mm outside the injection port. In this embodiment, the position of the secondary seal is selected to be 10mm outside the injection port, and the gas can be selected from air, nitrogen or inert gas. In order to ensure that the performance of the phase change energy storage microspheres will not be attenuated due to high-temperature molding of the product, an equal volume of gas is injected to replace the phase change energy storage microspheres when the intermediate product is heated and cured. After the heating and molding is completed, the injection port is opened to inject the phase change energy storage microspheres into the corresponding cavity, thereby ensuring the performance of the phase change energy storage microspheres. The volume of the injected gas in this step is consistent with the volume of the phase change energy storage microspheres that need to be injected into the final product.

[0050] Step S7: Alignment film drawing

[0051] The product in step S6 is placed into the lower mold of the forming mold, the edge of the plastic bag is aligned with the edge of the mold, the pressing frame is pressed, and finally the upper mold is closed and the lock is locked.

[0052] Step S8: Heating and forming

[0053] Place the mold containing the product on the heating device and press the start button to heat the mold. The heating molding process is 80-100°C and the curing time is 30-40 minutes. In this embodiment, the preferred temperature is 90°C and the curing time is 30 minutes.

[0054] Step S9: Pouring phase change material

[0055] The injection port of the phase change layer 3 of the formed product is cut open and the phase change energy storage microspheres are injected. The injection amount of the phase change energy storage microspheres is adjusted according to the size of the final breast prosthesis product.

[0056] Step S10: Phase change layer sealing

[0057] The injection port after the phase change energy storage microspheres are injected is cleaned and sealed with high frequency to obtain a silicone breast prosthesis.

[0058] Step S11: Edge trimming

[0059] The redundant edges of the breast prosthesis product in step S10 are trimmed off to obtain a silicone breast prosthesis with phase change energy storage function.

[0060] The sequence and numbers of the above steps are only for the convenience of understanding and explanation. In the actual production process, it is not necessary to follow this sequence. For example, the production of polymer plastic bags and the production of silicone gel can be carried out at the same time.

[0061] The silicone breast prosthesis with phase change energy storage function in the above embodiment comprises a first silicone layer using lightweight silicone gel on the outside and a second silicone layer using silicone gel with a larger specific gravity on the inside. The silicone gels of different specific gravities are used in combination, so that the weight of the silicone breast prosthesis is controlled within an appropriate range, making it more comfortable to wear and having a better supporting effect; corresponding convex parts are designed according to the shape of the breast prosthesis product and in combination with the human body shape, and guide grooves are formed between adjacent convex parts, so that the heat energy of the human body can be better discharged from the body, and the gas on the body-fitting surface can be effectively guaranteed to be unobstructed, so that the silicone breast prosthesis has good air permeability; in order to better improve the performance of phase change energy storage, a separate cavity is designed to accommodate phase change energy storage microspheres, allowing the microspheres to move in an independent space, so that the heat absorption and heat dissipation are more uniform; the phase change temperature of the selected phase change energy storage microspheres is 32-37°C, which is adapted to the human body temperature. When the human body temperature is higher than this temperature, the phase change energy storage microspheres begin to absorb heat energy and store the heat energy; when the human body temperature is higher than this temperature, the phase change energy storage microspheres begin to absorb heat energy and store it; When the temperature is lower than this temperature, the phase change energy storage microspheres begin to release the stored heat energy, so that the user will not feel stuffy when wearing it in summer. In winter, the silicone breast prosthesis can be properly heated to provide a certain amount of heat to the human body when the weather is cold, making it more comfortable and more humane to wear. In order to ensure that the phase change energy storage microspheres will not decay due to the high-temperature molding of the product, an equal volume of gas is injected to replace the phase change energy storage microspheres when the intermediate product is heated and cured. After the heating and molding is completed, the injection port is opened to inject the phase change energy storage microspheres into the corresponding cavity, thereby ensuring the performance of the phase change energy storage microspheres. The manufacturing method is to put a release film into the cavity injection port corresponding to the phase change layer, first seal the release film, and then seal it again outside the release film. When waiting to inject the phase change energy storage microspheres, the external seal is cut off, the release film is taken out, and the injection port is sealed after the phase change energy storage microspheres are injected. This process can simplify the steps of secondary injection and save production costs.

[0062] The present invention uses phase-change energy storage microspheres that are at the forefront of the industry to meet the individual needs of high-end consumers in the current market. Due to the inconsistency in the temperature resistance conditions of phase-change energy storage microspheres and silicone gel materials, the preparation method of the present invention uses gas as a space substitute for silicone gel molding, which not only saves product costs, but also does not generate waste to affect the environment. The present invention also designs air guide grooves based on the human body shape to solve the problem of stuffiness caused by poor air circulation. The present invention also adopts a multi-layer combination method to ensure that the material properties of each area are not affected by other factors.

[0063] The above embodiments are only for illustrating the technical concept and features of the present invention, and their purpose is to enable people familiar with the technology to understand the content of the present invention and implement it accordingly, and they cannot be used to limit the protection scope of the present invention. Any equivalent changes or modifications made according to the spirit of the present invention should be included in the protection scope of the present invention.

Claims

1. A method for making a silicone breast prosthesis, characterized in that: The silicone breast prosthesis comprises a phase change layer in the middle and a first silicone layer and a second silicone layer on both sides of the phase change layer, wherein the phase change layer is filled with a phase change material, and the phase change material is a phase change energy storage microsphere; the manufacturing method comprises the following steps: A polymer plastic bag with three cavities is prepared, and a plastic injection port is left corresponding to each cavity; Injecting silicone gel into the cavities corresponding to the first silicone layer and the second silicone layer through the injection ports respectively, and sealing them accordingly; Injecting gas into the cavity corresponding to the phase change layer through the glue injection port and then sealing it; The intermediate product having the first silicone layer, the second silicone layer and the phase change layer filled with gas is heated and cured to form; Cut the injection port of the phase change layer of the molded product and inject the phase change energy storage microspheres; After sealing, a silicone breast prosthesis with phase change energy storage function is obtained; The specific operation of gas injection sealing is as follows: a release film is placed in the injection port of the cavity corresponding to the phase change layer, and then gas is injected into the cavity. After the injection is completed, the release film is sealed, and after sealing, it is sealed again 8-12mm outside the injection port.

2. The method according to claim 1, characterized in that: When injecting phase change energy storage microspheres, first cut off the external seal, remove the release film, and then seal the injection port after injecting the phase change energy storage microspheres.

3. The method according to claim 1, characterized in that: The volume of the injected gas is the same as the volume of the injected phase change energy storage microspheres.

4. The method according to claim 1, characterized in that: The first silicone layer is filled with a first silicone gel, and the second silicone layer is filled with a second silicone gel; the specific gravity of the first silicone gel is smaller than that of the second silicone gel.

5. The method according to claim 4, characterized in that: The first silicone layer is located on the outside, and the second silicone layer is located on the inside.

6. The method according to claim 4, characterized in that: The specific gravity of the first silicone gel is 0.6-0.7 g / cm 3 The specific gravity of the second silicone gel is 0.9-1.1 g / cm 3 .

7. The manufacturing method according to claim 1, characterized in that: When preparing the polymer plastic bag: four polymer films are pressed together to form a polymer plastic bag having three cavities for accommodating the phase change layer, the first silicone layer and the second silicone layer.

8. The method according to claim 7, characterized in that: The polymer film is a polyurethane film.

9. The manufacturing method according to claim 1, characterized in that: The heating molding process is performed at a temperature of 80-100° C. and a curing time of 30-40 minutes.

10. The manufacturing method according to claim 2, characterized in that: The phase change temperature of the phase change energy storage microspheres is 32-37°C; when the human body temperature is higher than the phase change temperature, the phase change energy storage microspheres begin to absorb heat energy and store the heat energy; when the human body temperature is lower than the phase change temperature, the phase change energy storage microspheres begin to release the stored heat energy.

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