Simulated breast milk with strong cooling function and preparation method thereof

Abstract

The present application relates to health recovery product field, specifically disclose a kind of simulation breast milk with strong cooling function and preparation method thereof.The simulation breast milk includes inner silica gel layer, gel layer, middle silica gel layer and outer silica gel layer from inside to outside, when wearing, the inner silica gel layer is close to human body, and the outer silica gel layer is away from human body;The inner silica gel layer is filled with first silica gel, the gel layer is filled with hydrogel, the middle silica gel layer is filled with second silica gel, and the outer silica gel layer is filled with third silica gel.The simulation breast milk prepared by the present application effectively inhibits the temperature rise and sweating caused by heat accumulation in the area covered by breast milk by strong cooling mode, thereby effectively alleviating the generation of the common stuffy phenomenon of wearing silica gel breast milk.

Description

Technical Field

[0001] This invention relates to the field of health care and rehabilitation products, and specifically discloses a simulated breast prosthesis with a strong cooling function and its preparation method. Background Technology

[0002] Currently, breast prostheses on the market can be mainly divided into three categories: fabric-covered and filled prostheses, silicone elastomer prostheses, and other polymer elastomer prostheses. Among them, silicone elastomer prostheses have become the first choice for postoperative body shape restoration due to their advantages of high simulation of human tissue, good biocompatibility and safety, and reasonable weight distribution. Silicone elastomer breast prostheses can be further subdivided into two categories: those with and without film covering. Those without film covering use silicone gel with a certain degree of hardness and mechanical properties, which is solidified after liquid casting. Those with film covering mainly use low-hardness silicone gel as the internal filling, providing a more realistic feel. However, because the gel lacks self-support and has a certain degree of silicone oil migration, it is usually covered and isolated with an external polymer film.

[0003] In the field of silicone elastomer breast prostheses, invention patent CN103223191B discloses a silicone gel composition for making breast prostheses and its preparation method. This silicone gel exhibits elasticity and softness similar to human fat structure, with a low specific gravity, low hardness, and resistance to delamination, greatly improving wearing comfort. However, due to its poor breathability, in practical applications, especially in summer or in high ambient temperatures, wearers often experience stuffiness and sweating.

[0004] To address the issues of stuffiness and sweating, existing technologies often attempt to improve the gas exchange rate of breast prostheses by optimizing structural design and using chemical or physical methods such as microporous breast prostheses. However, these methods are not very effective, and because breast prostheses need to be worn with a bra, the improvement is further weakened, resulting in minimal practical effect. Summary of the Invention

[0005] To overcome the shortcomings of the prior art, this invention provides a simulated breast prosthesis with a powerful cooling function and its preparation method. The simulated breast prosthesis prepared by this invention is a novel polymer film-coated prosthesis. Through rapid conduction and absorption of heat from the human skin, i.e., powerful cooling, it effectively inhibits the temperature rise and sweating caused by heat accumulation in the prosthesis-covered area, achieving long-term effective temperature control of the user's epidermis, thereby effectively alleviating the stuffiness commonly found in silicone breast prostheses.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0007] The first aspect of the present invention provides a simulated breast prosthesis with a strong cooling function. The simulated breast prosthesis comprises, from the inside out, an inner silicone layer, a gel layer, a middle silicone layer, and an outer silicone layer. When worn, the inner silicone layer is close to the human body, and the outer silicone layer is away from the human body. The inner silicone layer is filled with a first silicone gel, the gel layer is filled with hydrogel, the middle silicone layer is filled with a second silicone gel, and the outer silicone layer is filled with a third silicone gel.

[0008] This invention constructs a novel simulated breast prosthesis structure by using an inner silicone layer, a gel layer, a middle silicone layer, and an outer silicone layer. The inner silicone layer incorporates specific functional fillers to balance the effects of efficiently absorbing heat from human skin and rapidly conducting it outwards.

[0009] In some embodiments of the present invention, the first silicone gel is a functional silicone gel comprising component A and component B, each component comprising the following parts by weight of raw materials:

[0010] Component A: 30-40 parts polydimethylsiloxane, 12-15 parts dimethyl silicone oil, 5-10 parts functional filler, 0.5-2 parts vinyl silicone oil, 0.1-0.5 parts color paste;

[0011] Component B: 35-50 parts polydimethylsiloxane, 10-15 parts dimethyl silicone oil, and 0.5-2 parts first catalyst.

[0012] In some embodiments of the present invention, the preparation steps of the functional silicone gel are as follows:

[0013] A1: Mix defoamed polydimethylsiloxane, dimethyl silicone oil and functional filler at 23-30℃ and stir thoroughly. Then add vinyl silicone oil and color paste and continue stirring until uniform to obtain component A.

[0014] A2: At 23-30℃, defoamed polydimethylsiloxane, dimethyl silicone oil and the first catalyst are mixed and stirred thoroughly to obtain component B;

[0015] A3: Mix the above components A and B, degas under negative pressure, and heat to solidify to obtain the functional silicone gel.

[0016] In some embodiments of the present invention, in step A3, component A and component B are mixed in a mass ratio of 1:1.

[0017] In some embodiments of the present invention, the functional filler is hexagonal boron nitride or zinc oxide-modified hexagonal boron nitride.

[0018] In some embodiments of the present invention, the functional filler is zinc oxide modified hexagonal boron nitride.

[0019] In some embodiments of the present invention, the preparation steps of the zinc oxide-modified hexagonal boron nitride are as follows:

[0020] (1) Add hydroxyethyl acrylate, vinyltriethoxysilane and initiator to solvent, heat to 70-80℃, react for 1-2 h to obtain intermediate product;

[0021] (2) Add isoflurane diisocyanate and organic solvent to the reactor, add the intermediate product of step (1) dropwise over 1-2 hours at 25-30°C, add the second catalyst, keep the reaction at the temperature for 5-6 hours, add hydroxyethyl acrylate under an inert atmosphere, raise the temperature to 70-80°C and react for 1-3 hours to obtain the modifier.

[0022] (3) Add the modifier and zinc oxide from step (2) to the solvent, heat to 70-80℃ and react for 3-5 hours, then add hexagonal boron nitride, sonicate for 20-40 minutes, stir and heat to 30-40℃ for 30-50 minutes, let stand, filter, wash, centrifuge and vacuum dry to obtain zinc oxide modified hexagonal boron nitride.

[0023] In some embodiments of the present invention, in step (1), the mass ratio of hydroxyethyl acrylate to vinyltriethoxysilane is 1:(1.2-2).

[0024] In some embodiments of the present invention, in step (2), the mass ratio of the isoflurane diisocyanate, the intermediate product of step (1), and hydroxyethyl acrylate is 1:(0.5-0.7):(0.2-0.4).

[0025] In some embodiments of the present invention, in step (3), the mass ratio of the modifier, zinc oxide and hexagonal boron nitride is (0.05-0.1):(0.2-0.5):1.

[0026] In some embodiments of the present invention, the specific gravity of the first silicone gel is 0.85–1.25 g / cm³. 3 .

[0027] This invention uses a combination of zinc oxide and hexagonal boron nitride as functional fillers to make the thermal conductivity network in the first gel more complete and efficient, significantly improving the thermal conductivity and cooling efficiency of the simulated breast prosthesis. The zinc oxide with the preferred particle size also brings some antibacterial and deodorizing effects, increasing the applicability of the simulated breast prosthesis.

[0028] The applicant also discovered that the functional filler obtained by compounding modified zinc oxide and hexagonal boron nitride unexpectedly improved the uniformity and integrity of the silicone gel vulcanization reaction. It is speculated that, on the one hand, the introduction of silicon-oxygen bonds and double bonds on it may improve the interfacial interaction, enhance the dispersion and compatibility, and provide more crosslinking sites; on the other hand, the covering of zinc oxide can also form a certain barrier effect, which improves its dispersibility in the system while reducing the direct contact between hexagonal boron nitride and the main component of silicone gel vulcanization, reducing the inhibitory effect of possible nitrides on the vulcanization reaction of silicone gel system, and ensuring the high performance of the first gel.

[0029] In some embodiments of the present invention, the hydrogel is one or more of sodium carboxymethyl cellulose, modified microcrystalline cellulose, and sodium polyacrylate, with a viscosity of 200,000 to 500,000 mPa·s and a water content of ≥80%.

[0030] This invention further incorporates a gel layer into the inner silicone layer. The high-water-content hydrogel has excellent heat absorption and storage properties. By absorbing a large amount of heat and conducting it to control the temperature, it works synergistically with the inner silicone layer to achieve long-term temperature control, greatly reducing the feeling of stuffiness when wearing the device. At the same time, the non-Newtonian fluid characteristics of the hydrogel also enhance the impact resistance of the simulated breast prosthesis. Furthermore, different viscosities can be selected according to the tactile requirements, making it widely applicable.

[0031] In some embodiments of the present invention, the specific gravity of the second silicone gel is 0.6–0.9 g / cm³. 3 .

[0032] In some embodiments of the present invention, the specific gravity of the third silica gel is 0.5–0.7 g / cm³. 3 .

[0033] In some embodiments of the present invention, the third silica gel is a lightweight silica gel.

[0034] In some embodiments of the present invention, the lightweight silica gel is a phase change temperature-controlled lightweight silica gel.

[0035] The present invention further configures a middle silicone layer, which forms a natural protective barrier, providing not only shock absorption but also preventing the gel layer from evaporating, thus ensuring the reliability of heat transfer and durability. At the same time, the outer layer is stacked with a lightweight silicone layer, which better simulates the softness and feel of the human breast, so that the new composite structure significantly improves the wearing comfort and functionality of the simulated breast prosthesis.

[0036] Another aspect of the present invention provides a method for preparing a simulated breast prosthesis with a strong cooling function, comprising the following steps:

[0037] S1: Preparation of polymer bags: Four polymer films are pressed together to form a polymer tape with four cavities that contain an inner silicone layer, a gel layer, a middle silicone layer and an outer silicone layer. Each cavity has a corresponding glue injection port.

[0038] S2: Preparation of silicone layer: The prepared first silicone gel is injected into the cavity corresponding to the inner silicone layer through each injection port, the prepared second silicone gel is injected into the cavity corresponding to the middle silicone layer, and the prepared third silicone gel is injected into the cavity corresponding to the outer silicone layer. After degassing, the corresponding cavity is sealed.

[0039] S3: Preparation of gel layer: Inject the prepared hydrogel into the cavity corresponding to the gel layer through the injection port and then vent and seal it;

[0040] S4: Heating and molding: The intermediate product with the inner silicone layer, gel layer, middle silicone layer and outer silicone layer obtained in the above steps is heated and cured to obtain the simulated breast prosthesis with strong cooling function.

[0041] In some embodiments of the present invention, the polymer film is polyurethane or thermoplastic polyurethane.

[0042] Preferably, the heating and curing conditions are curing at 80-100°C for 30-40 minutes.

[0043] Compared with the prior art, the present invention has the following beneficial effects:

[0044] 1. The simulated breast prosthesis prepared by this invention is a novel polymer film-coated breast prosthesis. By rapidly conducting and absorbing heat from the human skin, it effectively cools down the area covered by the prosthesis, thus inhibiting the rise in temperature and sweating caused by heat accumulation. This achieves long-term effective temperature control of the user's epidermis and effectively alleviates the stuffiness commonly found when wearing silicone breast prostheses.

[0045] 2. This invention constructs a novel simulated breast prosthesis structure by using an inner silicone layer, a gel layer, a middle silicone layer, and an outer silicone layer. The inner silicone layer incorporates specific functional fillers to balance the effects of efficiently absorbing heat from human skin and rapidly conducting it outward.

[0046] 3. The present invention further incorporates a gel layer into the inner silicone layer, which absorbs a large amount of heat and conducts temperature control. This works in conjunction with the inner silicone layer to achieve long-term temperature control, greatly reducing the feeling of stuffiness when wearing the device. On the other hand, the non-Newtonian fluid characteristics of the microcrystalline cellulose hydrogel with the preferred viscosity enhance the impact resistance of the simulated breast prosthesis.

[0047] 4. The specific middle silicone layer of this invention forms a natural protective barrier, which not only provides impact resistance and cushioning, but also blocks the evaporation of the gel layer, ensuring the reliability of heat transfer and durability. At the same time, the outer layer is equipped with a lightweight silicone layer, which better simulates the softness and feel of the human breast, so that the new composite structure significantly improves the wearing comfort and functionality of the breast prosthesis.

[0048] 5. This invention uses a combination of zinc oxide and hexagonal boron nitride as functional fillers, making the thermal conductivity network in the first gel more complete and efficient, significantly improving the thermal conductivity and cooling efficiency of the simulated breast prosthesis. The zinc oxide with the preferred particle size also brings some antibacterial and deodorizing effects, increasing the applicability of the simulated breast prosthesis. The applicant also found that the functional filler obtained by combining modified zinc oxide and hexagonal boron nitride reduces the inhibitory effect of possible nitrides on the vulcanization reaction of the silicone gel system, ensuring the high performance of the first gel and increasing the service life of the simulated breast prosthesis. Attached Figure Description

[0049] Figure 1 This is a cross-sectional view of a simulated breast prosthesis with a powerful cooling function according to an embodiment of the present invention.

[0050] The layers consist of: inner silicone layer-1, gel layer-2, middle silicone layer-3, and outer silicone layer-4. Detailed Implementation

[0051] The present invention will be described below with reference to specific embodiments. It should be noted that the examples and comparative examples below are for illustrative purposes only and are not intended to limit the invention. Other combinations and various modifications within the scope of the invention can be made without departing from its spirit or scope.

[0052] To facilitate implementation of this invention by those skilled in the art, the following description is provided regarding some of the raw materials and manufacturers used in the embodiments and comparative examples:

[0053] The compounds and related reagents used in the following examples and comparative examples are all commercially available medical-grade. It should be noted that all polymer films used are medical-grade polyurethane films, and there are no restrictions on the manufacturers. The preparation of the second and third silicone gels can be carried out by those skilled in the art according to the design scheme of the simulated breast prosthesis, by formulating the required silicone gel materials according to regulations. The second silicone gel used in the following examples and comparative examples can be prepared with reference to the composition and preparation method of the first silicone composition disclosed in Examples 1 and 2 of CN116172765A, and the third silicone gel can be prepared with reference to the composition and preparation method of the second silicone composition disclosed in Examples 1 and 2 of CN116172765A. All polydimethylsiloxanes used are medical-grade with a viscosity of 30. The viscosity of the polydimethylsiloxane used in the following examples and comparative examples is 40,000 mPa·s, ranging from 0.00 to 50,000 mPa·s. Those skilled in the art can select the appropriate viscosity based on different performance requirements. The dimethyl silicone oil used in the following examples and comparative examples has a viscosity of 20,000 mPa·s. The vinyl content of the vinyl silicone oil used is 15%. The first catalyst used is a platinum catalyst. The hydrogel used is sodium carboxymethyl cellulose with a viscosity of 250,000 mPa·s and a water content ≥80%. The particle size of the zinc oxide used is 1–5 μm. The particle size of the hexagonal boron nitride used is 10–15 μm.

[0054] Preparation Example 1

[0055] The preparation steps of zinc oxide modified hexagonal boron nitride are as follows:

[0056] (1) Add 5g of hydroxyethyl acrylate, 8g of vinyltriethoxysilane and 0.05g of azobisisobutyronitrile to 80mL of anhydrous ethanol, heat to 75℃ and react for 1.5h to obtain the intermediate product.

[0057] (2) Add 5g of isoflurane diisocyanate and 20mL of THF to the reactor. Add 3g of the intermediate product of step (1) dropwise over 1.5h at 28℃. Add 0.05g of dibutyltin dilaurate and keep warm for 5.5h. Then add 1.5g of hydroxyethyl acrylate under a nitrogen atmosphere and heat to 75℃ for 2h to obtain the modifier.

[0058] (3) Add 0.7g of the modifier from step (2) and 3.5g of zinc oxide to 50mL of anhydrous ethanol, heat to 75℃ and react for 4h, then add 10g of hexagonal boron nitride, sonicate for 30min, stir and heat to 35℃ for 40min, let stand, filter, wash, centrifuge and vacuum dry to obtain zinc oxide modified hexagonal boron nitride.

[0059] Preparation Example 2

[0060] The specific steps for modifying hexagonal boron nitride with zinc oxide are the same as in Preparation Example 1, except that the amount of modifier added in step (3) is 1.5g.

[0061] Preparation Example 3

[0062] The specific steps for modifying hexagonal boron nitride with zinc oxide are the same as in Preparation Example 1, except that the amount of zinc oxide added in step (3) is 6.5g.

[0063] Preparation Example 4

[0064] The preparation steps of zinc oxide modified hexagonal boron nitride are as follows: zinc oxide and hexagonal boron nitride are mixed evenly at a mass ratio of 0.35:1 to obtain the product.

[0065] Preparation Example 5

[0066] The functional silicone gel comprises component A and component B, each containing the following parts by weight of raw materials:

[0067] Component A: 35 parts polydimethylsiloxane, 13 parts dimethyl silicone oil, 7.5 parts functional filler, 1.5 parts vinyl silicone oil, 0.3 parts color paste;

[0068] Component B: 45 parts polydimethylsiloxane, 13 parts dimethyl silicone oil, and 1.5 parts primary catalyst.

[0069] The preparation steps of the functional silicone gel in this example are as follows:

[0070] A1: At 28°C, defoamed polydimethylsiloxane, dimethyl silicone oil and functional filler are mixed and stirred thoroughly. Then, vinyl silicone oil and color paste are added and stirred until homogeneous to obtain component A.

[0071] A2: At 28°C, defoamed polydimethylsiloxane, dimethyl silicone oil and the first catalyst are mixed and stirred thoroughly to obtain component B;

[0072] A3: Mix the above components A and B in a mass ratio of 1:1, degas under negative pressure, and cure at 120°C for 20 minutes to obtain functional silicone gel;

[0073] The functional filler used was zinc oxide modified hexagonal boron nitride obtained in Preparation Example 1.

[0074] Preparation Example 6

[0075] The functional silicone gel comprises component A and component B, each containing the following parts by weight of raw materials:

[0076] Component A: 30 parts polydimethylsiloxane, 12 parts dimethyl silicone oil, 5 parts functional filler, 0.5 parts vinyl silicone oil, 0.1 parts color paste;

[0077] Component B: 35 parts polydimethylsiloxane, 10 parts dimethyl silicone oil, and 0.5 parts first catalyst.

[0078] The preparation steps of the functional silicone gel in this example are as follows:

[0079] A1: At 23°C, defoamed polydimethylsiloxane, dimethyl silicone oil and functional filler are mixed and stirred thoroughly. Then, vinyl silicone oil and color paste are added and stirred until homogeneous to obtain component A.

[0080] A2: At 23°C, defoamed polydimethylsiloxane, dimethyl silicone oil and the first catalyst are mixed and stirred thoroughly to obtain component B;

[0081] A3: Mix the above components A and B in a mass ratio of 1:1, degas under negative pressure, and cure at 110°C for 30 minutes to obtain functional silicone gel.

[0082] The functional filler used was zinc oxide modified hexagonal boron nitride obtained in Preparation Example 1.

[0083] Preparation Example 7

[0084] The functional silicone gel comprises component A and component B, each containing the following parts by weight of raw materials:

[0085] Component A: 40 parts polydimethylsiloxane, 15 parts dimethyl silicone oil, 10 parts functional filler, 2 parts vinyl silicone oil, 0.5 parts color paste;

[0086] Component B: 50 parts polydimethylsiloxane, 15 parts dimethyl silicone oil, and 2 parts primary catalyst.

[0087] The preparation steps of the functional silicone gel in this example are as follows:

[0088] A1: At 30°C, defoamed polydimethylsiloxane, dimethyl silicone oil and functional filler are mixed and stirred thoroughly. Then, vinyl silicone oil and color paste are added and stirred until homogeneous to obtain component A.

[0089] A2: At 30°C, defoamed polydimethylsiloxane, dimethyl silicone oil and the first catalyst are mixed and stirred thoroughly to obtain component B;

[0090] A3: Mix the above components A and B in a mass ratio of 1:1, degas under negative pressure, and cure at 125°C for 25 minutes to obtain functional silicone gel.

[0091] The functional filler used was zinc oxide modified hexagonal boron nitride obtained in Preparation Example 1.

[0092] Preparation Example 8

[0093] The specific preparation steps of the functional silicone gel are the same as in Example 5, except that the functional filler used is the zinc oxide modified hexagonal boron nitride obtained in Preparation Example 2.

[0094] Preparation Example 9

[0095] The specific preparation steps of the functional silicone gel are the same as in Example 5, except that the functional filler used is the zinc oxide modified hexagonal boron nitride obtained in Preparation Example 3.

[0096] Preparation Example 10

[0097] The specific preparation steps of the functional silicone gel are the same as in Example 5, except that the functional filler used is the zinc oxide modified hexagonal boron nitride obtained in Preparation Example 4.

[0098] Preparation Example 11

[0099] The specific preparation steps of the functional silicone gel are the same as in Example 5, except that the functional filler used is hexagonal boron nitride.

[0100] Example 1

[0101] Reference Appendix Figure 1 A method for preparing a simulated breast prosthesis with a strong cooling function includes the following steps:

[0102] S1: Preparation of polymer bags: Four polymer films are pressed together to form a polymer tape with four cavities that contain an inner silicone layer 1, a gel layer 2, a middle silicone layer 3, and an outer silicone layer 4. Each cavity has a corresponding glue injection port.

[0103] S2: Preparation of the silicone layer: The prepared functional gel (obtained in Preparation Example 5, with a specific gravity of 1 g / cm³) is dispensed through each injection port. 3 The prepared second silica gel (with a specific gravity of 0.7 g / cm³) was injected into the cavity corresponding to the inner silica layer 1. 3 The prepared third silica gel (with a specific gravity of 0.6 g / cm³) was injected into the cavity corresponding to the middle silica layer 3. 3 Injected into the cavity corresponding to the outer silicone layer 4, and sealed after venting;

[0104] S3: Preparation of gel layer 2: Inject the prepared hydrogel into the cavity corresponding to gel layer 2 through the injection port and then vent and seal it;

[0105] S4: Heating and molding: The intermediate product with the inner silicone layer 1, gel layer 2, middle silicone layer 3 and outer silicone layer 4 obtained in the above steps is cured at 90°C for 35 minutes to form the simulated breast prosthesis with strong cooling function.

[0106] Example 2

[0107] Reference Appendix Figure 1 A method for preparing a simulated breast prosthesis with a strong cooling function includes the following steps:

[0108] S1: Preparation of polymer bags: Four polymer films are pressed together to form a polymer tape with four cavities that contain an inner silicone layer 1, a gel layer 2, a middle silicone layer 3, and an outer silicone layer 4. Each cavity has a corresponding glue injection port.

[0109] S2: Preparation of the silicone layer: The prepared functional gel (obtained in Preparation Example 6, with a specific gravity of 0.85 g / cm³) is dispensed through each injection port. 3 The prepared second silica gel (with a specific gravity of 0.6 g / cm³) was injected into the cavity corresponding to the inner silica layer 1. 3 The prepared third silica gel (with a specific gravity of 0.5 g / cm³) was injected into the cavity corresponding to the middle silica layer 3. 3 Injected into the cavity corresponding to the outer silicone layer 4, and sealed after venting;

[0110] S3: Preparation of gel layer: Inject the prepared hydrogel into the cavity corresponding to gel layer 2 through the injection port and then vent and seal it;

[0111] S4: Heating and molding: The intermediate product with the inner silicone layer 1, gel layer 2, middle silicone layer 3 and outer silicone layer 4 obtained in the above steps is cured at 80°C for 40 minutes to form the simulated breast prosthesis with strong cooling function.

[0112] Example 3

[0113] Reference Appendix Figure 1 A method for preparing a simulated breast prosthesis with a strong cooling function includes the following steps:

[0114] S1: Preparation of polymer bags: Four polymer films are pressed together to form a polymer tape with four cavities that contain an inner silicone layer 1, a gel layer 2, a middle silicone layer 3, and an outer silicone layer 4. Each cavity has a corresponding glue injection port.

[0115] S2: Preparation of the silicone layer: The prepared functional gel (obtained in Preparation Example 7, with a specific gravity of 1.25 g / cm³) is dispensed through each injection port. 3The prepared second silica gel (with a specific gravity of 0.9 g / cm³) was injected into the cavity corresponding to the inner silica layer 1. 3 The prepared third silica gel (with a specific gravity of 0.7 g / cm³) was injected into the cavity corresponding to the middle silica layer 3. 3 Injected into the cavity corresponding to the outer silicone layer 4, and sealed after venting;

[0116] S3: Preparation of gel layer: Inject the prepared hydrogel into the cavity corresponding to gel layer 2 through the injection port and then vent and seal it;

[0117] S4: Heating and molding: The intermediate product with the inner silicone layer 1, gel layer 2, middle silicone layer 3 and outer silicone layer 4 obtained in the above steps is cured at 100°C for 30 minutes to form the simulated breast prosthesis with strong cooling function.

[0118] Example 4

[0119] A simulated breast prosthesis with strong cooling function and its preparation method are described. The specific implementation method is the same as in Example 1, except that the functional gel used is obtained from Preparation Example 8.

[0120] Example 5

[0121] A simulated breast prosthesis with strong cooling function and its preparation method are described. The specific implementation method is the same as in Example 1, except that the functional gel used is obtained from Preparation Example 9.

[0122] Example 6

[0123] A simulated breast prosthesis with strong cooling function and its preparation method are described. The specific implementation method is the same as in Example 1, except that the functional gel used is obtained from Preparation Example 10.

[0124] Example 7

[0125] A simulated breast prosthesis with strong cooling function and its preparation method are described. The specific implementation method is the same as in Example 1, except that the functional gel used is obtained from Preparation Example 11.

[0126] Comparative Example 1

[0127] A simulated breast prosthesis with strong cooling function and its preparation method are described. The specific implementation method is the same as in Example 1, except that the structure of the simulated breast prosthesis does not contain a gel layer.

[0128] Comparative Example 2

[0129] A simulated breast prosthesis with strong cooling function and its preparation method are disclosed. The specific implementation method is the same as in Example 1, except that the structure of the simulated breast prosthesis does not contain a middle silicone layer.

[0130] Performance testing

[0131] 1. Heat absorption performance: Heat absorption performance was simulated with reference to standard GB / T 43573-2023. The temperature rise time (i.e., constant temperature time) of each simulated breast prosthesis covered with warm body mannequins was recorded to characterize the heat absorption and cooling performance of simulated breast prostheses.

[0132] 2. Durability: High temperature and high humidity aging simulation was conducted in accordance with standard GB / T 14831-2003 to test the change in hardness in order to characterize the durability of each simulated breast prosthesis.

[0133] The specific test results are shown in Table 1:

[0134] Table 1

[0135] Isothermal time (min) Hardness change (%) Example 1 240 5 Example 2 225 7 Example 3 250 8 Example 4 190 11 Example 5 210 10 Example 6 150 13 Example 7 130 14 Comparative Example 1 110 17 Comparative Example 2 180 18

[0136] A comparison of the experimental data in Table 1 between Examples 1-3 shows that the simulated breast prosthesis obtained by this invention has good thermal conductivity and cooling capacity, and strong durability. A comparison between Example 4 and Example 1 shows that the functional gel used was obtained from Preparation Example 8. This may be due to a change in the amount of modifier added during the preparation of zinc oxide-modified hexagonal boron nitride, which affects the thermal conductivity space density of the functional filler and the vulcanization molding of the functional gel, leading to a decrease in durability. A comparison between Example 5 and Example 1 shows that the functional gel used was obtained from Preparation Example 9. The change in the amount of zinc oxide added affected the thermal conductivity network and durability of the simulated breast prosthesis to varying degrees. Comparing Example 6 with Example 1, it can be seen that the functional gel used was obtained from Preparation Example 10. Directly mixing zinc oxide and hexagonal boron nitride as a functional filler reduces the functionality of this system, resulting in a significant decrease in the thermal absorption performance and durability of the simulated breast prosthesis. Comparing Example 7 with Example 1, it can be seen that when hexagonal boron nitride is used as a functional filler, the overall performance of the simulated breast prosthesis decreases. Comparing Comparative Example 1 with Example 1, it can be seen that the simulated breast prosthesis structure does not contain a gel layer, which significantly affects its synergistic heat dissipation and cooling effect on the inner silicone layer. Comparing Comparative Example 2 with Example 1, it can be seen that the simulated breast prosthesis structure does not contain a middle silicone layer, resulting in a significant decrease in the durability of the simulated breast prosthesis.

[0137] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A simulated breast milk with strong cooling function, characterized in that, The simulated breast prosthesis comprises, from the inside out, an inner silicone layer, a gel layer, a middle silicone layer, and an outer silicone layer. When worn, the inner silicone layer is close to the body, and the outer silicone layer is away from the body. The inner silicone layer is filled with a first silicone gel, the gel layer is filled with hydrogel, the middle silicone layer is filled with a second silicone gel, and the outer silicone layer is filled with a third silicone gel. The first silicone gel is a functional silicone gel, comprising component A and component B, each component containing the following parts by weight of raw materials: Component A: 30-40 parts polydimethylsiloxane, 12-15 parts dimethyl silicone oil, 5-10 parts functional filler, 0.5-2 parts vinyl silicone oil, 0.1-0.5 parts color paste; Component B: 35-50 parts polydimethylsiloxane, 10-15 parts dimethyl silicone oil, 0.5-2 parts first catalyst; The functional filler is zinc oxide-modified hexagonal boron nitride; the preparation steps of the zinc oxide-modified hexagonal boron nitride are as follows: (1) Add hydroxyethyl acrylate, vinyltriethoxysilane and initiator to solvent, heat to 70-80℃, react for 1-2 h to obtain intermediate product; (2) Add isoflurane diisocyanate and organic solvent to the reactor, add the intermediate product of step (1) dropwise over 1-2 hours at 25-30°C, add the second catalyst, keep the reaction at the temperature for 5-6 hours, add hydroxyethyl acrylate under an inert atmosphere, raise the temperature to 70-80°C and react for 1-3 hours to obtain the modifier. (3) Add the modifier and zinc oxide from step (2) into the solvent, heat to 70-80℃ and react for 3-5 hours, then add hexagonal boron nitride, sonicate for 20-40 minutes, stir and heat to 30-40℃ for 30-50 minutes, let stand, filter, wash, centrifuge and vacuum dry to obtain zinc oxide modified hexagonal boron nitride; The hydrogel is one or more of sodium carboxymethyl cellulose, modified microcrystalline cellulose, and sodium polyacrylate, with a viscosity of 200,000 to 500,000 mPa·s and a water content of ≥80%. The third silica gel is a phase change temperature-controlled lightweight silica gel.

2. The simulated breast prosthesis with powerful cooling function according to claim 1, characterized in that, The preparation steps of the functional silicone gel are as follows: A1: Mix defoamed polydimethylsiloxane, dimethyl silicone oil and functional filler at 23-30℃ and stir thoroughly. Then add vinyl silicone oil and color paste and continue stirring until uniform to obtain component A. A2: At 23-30℃, defoamed polydimethylsiloxane, dimethyl silicone oil and the first catalyst are mixed and stirred thoroughly to obtain component B; A3: Mix the above components A and B, degas under negative pressure, and heat to solidify to obtain the functional silicone gel.

3. The simulated breast prosthesis with powerful cooling function according to claim 1, characterized in that, The specific gravity of the second silica gel is 0.6-0.9 g / cm 3 .

4. A method for preparing a simulated breast prosthesis with a powerful cooling function as described in any one of claims 1-3, characterized in that, Includes the following steps: S1: Preparation of polymer bags: Four polymer films are pressed together to form a polymer tape with four cavities that contain an inner silicone layer, a gel layer, a middle silicone layer and an outer silicone layer. Each cavity has a corresponding glue injection port. S2: Preparation of silicone layer: The prepared first silicone gel is injected into the cavity corresponding to the inner silicone layer through each injection port, the prepared second silicone gel is injected into the cavity corresponding to the middle silicone layer, and the prepared third silicone gel is injected into the cavity corresponding to the outer silicone layer. After degassing, the corresponding cavity is sealed. S3: Preparation of gel layer: Inject the prepared hydrogel into the cavity corresponding to the gel layer through the injection port and then vent and seal it; S4: Heating and molding: The intermediate product with the inner silicone layer, gel layer, middle silicone layer and outer silicone layer obtained in the above steps is heated and cured to obtain the simulated breast prosthesis with strong cooling function.

5. The method for preparing a simulated breast prosthesis with a strong cooling function according to claim 4, characterized in that, The polymer film is polyurethane or thermoplastic polyurethane.

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