Artificial breast and method for manufacturing the same

Abstract

The application discloses a breast prosthesis and a preparation method thereof. The breast prosthesis comprises a main body layer and a phase change layer, the main body layer is formed by curing a first silica gel composition, and the phase change layer is formed by curing a second silica gel composition. The first silica gel composition comprises a silica gel, polystyrene microcapsules and a phase change polyol. The second silica gel composition comprises a silica gel and a phase change polyol. The mass percentage of the phase change polyol in the second silica gel composition is greater than the mass percentage of the phase change polyol in the first silica gel composition. The breast prosthesis comprises a main body layer and a phase change layer. The phase change polyol material used for preparing the main body layer and the phase change layer can be directly mixed with the silica gel, and the breast prosthesis can be obtained by one-piece molding, so that the preparation process is simplified. In addition, the phase change polyol and the silica gel are directly and integrally cured by heating, so that the stability of the product form can be ensured, and liquid leakage after the TPU film on the surface of the breast prosthesis is damaged can be avoided, and the safety of wearing can be ensured.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of clothing products, in particular to a breast prosthesis and a preparation method thereof. BACKGROUND

[0002] According to statistical data, in recent years, the proportion of women with breast cancer is increasing. With the development of economy and the progress of society, people's demand for the quality of life is constantly improving. The conventional breast prosthesis can only meet the morphological compensation, but when worn for a long time in summer, it will cause stuffiness, and when worn for a long time in winter, it will cause coldness. The conventional breast prosthesis cannot meet the needs of consumers who pursue high-quality life.

[0003] In view of the above situation, there are currently breast prostheses with phase change energy storage function on the market, such as a silicone breast prosthesis with phase change energy storage function and a preparation method thereof with a patent number of CN107839146A. It discloses a silicone breast prosthesis with phase change energy storage function, which includes a phase change layer. The phase change temperature of the phase change layer is 32-37℃, which is suitable for the human body temperature. When the human body temperature is higher than this temperature, the phase change energy storage microspheres in the phase change layer 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 the breast prosthesis in summer, and the breast prosthesis can be properly heated in winter to provide certain heat energy to the human body in cold weather, making the wearing comfortable and humanized. However, the phase change material used cannot be directly mixed with the silicone gel, because the silicone gel needs to be heated to solidify and form. The phase change material uses paraffin as the main phase change body, which will change from solid to liquid during the heating process and react with the silicone gel, causing the silicone gel to be poisoned and not to solidify, so the phase change material cannot withstand high temperature. This results in the breast prosthesis being unable to be integrally formed during the final shaping, and can only be processed in steps: adding an appropriate amount of gas to the independent space (hollow capsule structure) of the phase change material when the colloid is solidified and formed, and then injecting the phase change material after the colloid is solidified and formed. The above preparation process is complicated and inconvenient to operate. In addition, the phase change material injected in the current breast prostheses on the market is mostly in liquid or microbead form. Once the TPU (Thermoplastic Polyurethanes, thermoplastic polyurethane elastomer) film on the surface of the breast prosthesis is damaged, the internal phase change material will definitely leak, which will pollute the user's clothes and cause the user to be embarrassed in public, bringing great inconvenience to the user. SUMMARY

[0004] Therefore, in order to overcome the defects of the prior art, the purpose of the present application is to provide a breast prosthesis and a preparation method thereof. The silicone gel material for preparing the breast prosthesis contains a polyol phase change material, which can be integrally solidified and formed with the silicone gel at high temperature, which can not only simplify the production process, but also avoid the problem of phase change material leakage caused by the damage of the TPU film.

[0005] To achieve the above object, the present application adopts the following technical solutions:

[0006] In one aspect, the present application provides an artificial breast, comprising a main body layer and a phase change layer, the main body layer is cured from a first silica gel composition, the phase change layer is cured from a second silica gel composition; the first silica gel composition comprises silica gel, polystyrene microcapsules and phase change polyol, the second silica gel composition comprises silica gel and phase change polyol; the mass percentage of phase change polyol in the second silica gel composition is greater than the mass percentage of phase change polyol in the first silica gel composition. Selecting phase change polyol material as the phase change main body of the main body layer and the phase change layer of the artificial breast can be directly added to the silica gel for integrated warming and curing, which not only ensures the stability of the product form, but also simplifies the complicated process. The addition of phase change polyol may play a role in adsorbing polystyrene microcapsules, thereby slowing down the floating speed of polystyrene microcapsules during preparation, so that the silica gel and polystyrene microcapsules are uniformly mixed in silicone oil, avoiding rapid stratification of raw materials.

[0007] Preferably, the mass percentage of phase change polyol in the first silica gel composition is 5%-15%, and the mass percentage of phase change polyol in the second silica gel composition is 45%-55%.

[0008] Preferably, the first silica gel composition comprises silica gel and polystyrene microcapsules, and the mass ratio of polystyrene microcapsules to silica gel in the first silica gel composition is 1:70-90, preferably 70%-80%.

[0009] Preferably, the phase change polyol is polyester polyol; and the phase change temperature thereof is 34-36℃, preferably 35℃.

[0010] Preferably, the specific gravity of the main body layer is 0.6-0.7g / mm 3 , preferably 0.65g / mm 3 , and the specific gravity of the phase change layer is 0.75-0.85g / mm 3 , preferably 0.8g / mm 3 .

[0011] More preferably, the first silica gel composition comprises the following components in weight parts:

[0012] Silica gel 900-1100 parts Polystyrene microcapsules 10-15 parts

[0013] Phase change polyol 50-1100 parts.

[0014] Preferably, the polystyrene microcapsules are added to reduce the specific gravity of the prepared body layer, so as to obtain a light silica gel as the body layer, thereby realizing the light weight of the breast prosthesis body.

[0015] More preferably, the first silica gel composition comprises the following components in parts by weight:

[0016] Silica gel 900-1100 parts

[0017] Phase change polyol 50-1100 parts.

[0018] More preferably, the breast prosthesis comprises a contact layer, the body layer, the phase change layer and the contact layer are arranged in sequence from outside to inside, and the contact layer is provided with convex points on the side away from the phase change layer. The contact layer is formed by curing a high-transparency silica gel, and the contact layer is provided with a plurality of convex points on the side away from the phase change layer, and flow guide grooves are formed between adjacent convex points, so that the heat of the user's body surface wearing the breast prosthesis can be smoothly discharged to the outside.

[0019] Preferably, a film layer is provided on the side of the body layer away from the phase change layer, between the body layer and the phase change layer, between the phase change layer and the contact layer, and on the side of the contact layer away from the phase change layer. In some embodiments of the present application, the material of the film layer is a high-transparency, low-hardness, hydrolysis-resistant polyether TPU, which can effectively improve the comfortable contact feeling of the breast prosthesis with the skin. In some embodiments of the present application, the first silica gel composition of the body layer, the second silica gel composition of the phase change layer and the silica gel of the contact layer are simultaneously heated and cured to form the final breast prosthesis.

[0020] In another aspect, the present application provides a preparation method of the above breast prosthesis, which specifically comprises the following steps:

[0021] 1) Preparing a high-molecular film bag: four pieces of high-molecular film are pressed together on a high-frequency device to form a high-molecular film bag, the high-molecular film bag has three cavities for accommodating the first silica gel composition, the second silica gel composition and the high-transparency silica gel respectively, and each cavity is left with a glue injection port;

[0022] 2) Glue injection: the prepared first silica gel composition, the second silica gel composition and the high-transparency silica gel are respectively injected into the corresponding cavities through the glue injection ports of each cavity;

[0023] 3) Degassing: the high-molecular film bag after glue injection is subjected to vacuum degassing;

[0024] 4) Sealing: the air in the vacuum-treated high-molecular film bag is exhausted, the residual glue in the glue injection port is scraped off, and the glue injection port is sealed;

[0025] 5) solidification molding: the sealed polymer film bag is placed in the corresponding molding mold for heating and solidification, and the excess polymer film on the edge of the molded breast form is trimmed to ensure the edge is neat, thereby obtaining the breast form.

[0026] In the above preparation step, the breast form is obtained by simultaneously heating and solidifying the main body layer, the phase change layer and the contact layer. Compared with ordinary phase change materials, the phase change polyol used as the phase change material is not affected by high temperature in the heating and solidification process, so when the silica gel is solidified, the first silica gel composition in the main body layer, the second silica gel composition in the phase change layer and the high-transparency silica gel in the contact layer can be simultaneously solidified to integrally form the breast form product, thereby avoiding the need to first solidify the silica gel by heating and molding and then pouring the phase change material into the product in the prior art, effectively simplifying the preparation process and improving the production efficiency.

[0027] Due to the above technical solutions, compared with the prior art, the breast form of the present application has the following advantages: the phase change polyol material used to prepare the main body layer and the phase change layer can be directly mixed with the silica gel, and in the process, the required silica gel material can be prepared by integrally molding without step-by-step processing, thereby greatly simplifying the preparation process and avoiding complicated operation steps; in the product, the polyol and the silica gel are directly integrally solidified and molded by heating, which can ensure the stability of the product form and avoid liquid leakage after the TPU film on the surface of the breast form is damaged, thereby ensuring the wearer's peace of mind. DETAILED DESCRIPTION

[0028] In order for those skilled in the art to better understand the technical solutions of the present application, the technical solutions in the embodiments of the present application will be described clearly and completely below. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor should fall within the scope of protection of the present application.

[0029] Silica gel, specific gravity 1.2 g / mm 3 , Wacker Chemical, product model 7616-195, commercially available;

[0030] Polystyrene microcapsules, specific gravity 2 x 10 -5 g / mm 3 , AkzoNobel Group, product model 461DET40d25, commercially available;

[0031] Phase change polyester polyol, phase change temperature 35℃, phase change enthalpy ≥180 J / g, particle size of powder particles 10-25 μm, thermal stability weight loss rate ≤1% when heated to 100℃, specific gravity 0.7 g / mm 3PCM-Y20, commercially available from Shanghai Cunminglu Technology Co., Ltd.

[0032] The following examples are prepared using the above-mentioned materials.

[0033] Example 1: A breast prosthesis

[0034] The breast prosthesis of the present example comprises, in order from the outside in, a main body layer, a phase change layer, and a contact layer, and the contact layer is provided with convex points on the side away from the phase change layer. The side of the main body layer away from the phase change layer, the space between the main body layer and the phase change layer, the space between the phase change layer and the contact layer, and the side of the contact layer away from the phase change layer are all provided with a TPU film layer.

[0035] The main body layer of the present example is formed by heating and curing a first silica gel composition, the phase change layer is formed by heating and curing a second silica gel composition, and the contact layer is formed by heating and curing a high-transparency silica gel.

[0036] The first silica gel composition of the present example comprises the following components in the following proportions by weight:

[0037] Silica gel 1000 parts

[0038] Polystyrene microcapsules 13 parts

[0039] Phase change polyester polyol 115 parts.

[0040] The mass of the above-mentioned phase change polyester polyol accounts for 10% of the mass of the first silica gel composition, and the specific gravity of the first silica gel composition is 0.65 g / mm 3 .

[0041] The second silica gel composition of the present example comprises the following components in the following proportions by weight:

[0042] Silica gel 1000 parts

[0043] Phase change polyester polyol 1000 parts.

[0044] The mass of the above-mentioned phase change polyester polyol accounts for 50% of the mass of the second silica gel composition, and the specific gravity of the second silica gel composition is 0.8 g / mm 3 ;

[0045] The second silica gel composition increases the amount of phase change material polyester polyol compared to the first silica gel composition, which aims to achieve better phase change function.

[0046] Example 2: Preparation method of first silica gel composition, second silica gel composition, and high-transparency silica gel

[0047] The embodiment provides a first silica gel composition, a second silica gel composition and a preparation method of high-transparency silica gel for forming a breast prosthesis main body layer, a phase change layer and a contact layer, and specifically as follows.

[0048] Preparation of the first silica gel composition: 1000 parts of silica gel are weighed, 13 parts of polystyrene microcapsules and 115 parts of phase change polyester polyol are added into the silica gel, the container opening is effectively closed, a turnover stirrer is used for stirring at 800 r / min until no floating powder exists, and then high-speed stirring at 4000 r / min is conducted until the powder is completely and uniformly dispersed in the system.

[0049] Preparation of the second silica gel composition: 1000 parts of silica gel are weighed, 1000 parts of phase change polyester polyol are added into the silica gel, the container opening is effectively closed, a turnover stirrer is used for stirring at 800 r / min until no floating powder exists, and then high-speed stirring at 4000 r / min is conducted until the powder is completely and uniformly dispersed in the system.

[0050] Preparation of the high-transparency silica gel: 1000 parts of high-transparency silica gel A component and 1000 parts of high-transparency silica gel B component are respectively added into containers and fully stirred to be uniformly mixed.

[0051] The prepared first silica gel composition and second silica gel composition are placed into a vacuum box for defoaming, and are taken out after the vacuum indication number reaches-0.1 MPa and is kept for 10-20 minutes.

[0052] Preparation method of a breast prosthesis

[0053] The embodiment further provides the preparation method of the breast prosthesis, and comprises the following steps.

[0054] 1) Preparation of a TPU film bag: four cut TPU films are placed on a high-frequency device and are pressed to form a TPU film bag, the TPU film bag has three cavities for containing the first silica gel composition, the second silica gel composition and the high-transparency silica gel respectively, and an injection port is left in each cavity;

[0055] 2) Glue injection: the first silica gel composition, the second silica gel composition and the high-transparency silica gel are loaded into a double-barrel, a glue mixing pipe is connected, and the first silica gel composition, the second silica gel composition and the high-transparency silica gel are respectively injected into the corresponding cavities through the injection ports of the cavities;

[0056] 3) Defoaming: the TPU film bag after the glue injection in step 2 is placed into a vacuum box for defoaming, and is taken out after the vacuum indication number reaches-0.1 MPa and is kept for 10 minutes.

[0057] 4) sealing: the air in the TPU film bag treated by vacuum in step 3 is discharged, the residual glue in the glue injection port is scraped off, and the glue injection port is sealed by using a high-frequency sealing device;

[0058] 5) curing molding: the sealed TPU film bag is placed in the corresponding molding mold for heating and curing, a negative pressure air pipe is inserted into the mold to discharge the air in the mold cavity, and the mold is placed on a turnover heating baking molding machine for heating and curing (the program of the molding machine is set to turn over every 3 minutes for a total of 5 times); and the excess TPU film on the edge of the molded breast prosthesis is trimmed to ensure that the edge is neat, thereby obtaining the breast prosthesis.

[0059] The above examples are only for illustrating the technical concept and characteristics of the present application, and the purpose is to enable those skilled in the art to understand the content of the present application and implement it, and cannot limit the protection scope of the present application. Any equivalent changes or modifications made according to the spirit and essence of the present application shall be covered within the protection scope of the present application.

Claims

1. A breast prosthesis, characterized in that The prosthesis comprises a body layer, a phase change layer and a contact layer, the body layer is formed by curing a first silica gel composition, the phase change layer is formed by curing a second silica gel composition, and the contact layer is formed by curing a high-transparency silica gel, the prosthesis is formed by simultaneously curing and molding the first silica gel composition of the body layer, the second silica gel composition of the phase change layer and the silica gel of the contact layer; the first silica gel composition comprises silica gel, polystyrene microcapsules and phase change polyol, the second silica gel composition comprises silica gel and phase change polyol, and the mass percentage of the phase change polyol in the second silica gel composition is greater than the mass percentage of the phase change polyol in the first silica gel composition. The mass percentage of the phase change polyol in the first silica gel composition is 5-15%, and the mass percentage of the phase change polyol in the second silica gel composition is 45-55%; the phase change polyol is polyester polyol, and the phase change temperature of the phase change polyol is 34-36℃.

2. The artificial breast according to claim 1, characterized in that The specific gravity of the main body layer is 0.6-0.7 g / mm 3 The specific gravity of the phase change layer is 0.75-0.85 g / mm 3 .

3. The artificial breast according to claim 1, wherein The mass ratio of the polystyrene microcapsules to the silica gel in the first silica gel composition is 1:70-90.

4. The artificial breast according to claim 3, wherein The first silica gel composition comprises the following components in the following weight ratio: Silica gel 900-1100 parts Polystyrene microcapsules 10-15 parts Phase change polyol 50-1100 parts.

5. The artificial breast according to claim 1, wherein The second silica gel composition comprises the following components in the following weight ratio: Silica gel 900-1100 parts Phase change polyol 50-1100 parts.

6. The artificial breast according to claim 1, wherein The body layer, the phase change layer and the contact layer are arranged from outside to inside, and the contact layer is provided with convex points away from the phase change layer.

7. The artificial breast according to claim 6, characterized in that The body layer is provided with the film layer away from the phase change layer, between the body layer and the phase change layer, between the phase change layer and the contact layer, and away from the phase change layer on the side of the contact layer.

8. A method of manufacturing a breast prosthesis according to any one of claims 1 to 7, characterized in that The method comprises the following steps: 1) Preparing a high-molecular film bag: four pieces of high-molecular film are pressed together on a high-frequency device to form a high-molecular film bag, the high-molecular film bag has three cavities for accommodating the first silica gel composition, the second silica gel composition and the high-transparency silica gel respectively, and each cavity is left with a glue injection port; 2) Glue injection: the prepared first silica gel composition, the second silica gel composition and the high-transparency silica gel are respectively injected into the corresponding cavities through the glue injection ports of each cavity; 3) Deaeration: the high-molecular film bag after glue injection is subjected to vacuum deaeration; 4) Sealing: the air in the vacuum-treated high-molecular film bag is exhausted, the residual glue in the glue injection port is scraped off, and the glue injection port is sealed; 5) Curing and molding: the sealed high-molecular film bag is placed in a corresponding molding mold for heating and curing, and the excess high-molecular film on the edge of the molded prosthesis is trimmed to ensure the edge is neat, thereby obtaining the prosthesis.