Lightweight prosthetic implant

Abstract

Provided are a prosthetic implant and a method for manufacturing same, the prosthetic implant comprising: a silicone shell; and a filler injected into the silicone shell, wherein the silicone shell comprises two or more first silicone layers which form the inner and outer surfaces of the silicone shell, and one or more second silicone layers disposed between the two or more first silicone layers, and the one or more second silicone layers comprise pores.

Description

lightweight artificial implants

[0001] The present invention relates to an artificial implant having a light weight, in which pores are formed in at least a portion of a silicone shell.

[0002] Artificial implants are Class 4 medical devices that exist within the body and are applied to various parts of the body, such as the nose and breasts. In particular, most artificial implants consist of a silicone shell forming the outer layer of the implant filled with a gel or saline solution of appropriate viscosity. Since exceptional stability is required within the body, the implant industry has secured the physical properties required for medical devices by methods such as adjusting the thickness of the silicone shell or changing the composition of the filler. Generally, research and development is underway to achieve a natural shape by adjusting the physical properties of the filler.

[0003] Artificial implants currently available on the market are manufactured from silicone, which is sized to replace human tissues such as breasts and possesses significant size and weight. Therefore, while they offer the advantage of having characteristics very similar to the shape and physical properties of living tissues, they have a limitation in that they are relatively heavy due to their higher density compared to biological tissues.

[0004] Therefore, when existing artificial implants are installed in the body, a foreign body sensation may be felt, and they may cause discomfort by imposing an excessive load on the body or lead to other diseases such as scoliosis or herniated discs.

[0005] However, at present, there are no raw materials other than silicone that can be inserted into the body and guarantee safety for more than 10 years, so there is a need to develop artificial implants with a new structure to reduce weight while maintaining the physical properties of such artificial implants.

[0006] The present invention is intended to solve the problems revealed in the aforementioned prior art, and one of the various objectives of the present invention is to provide an artificial implant having a relatively lightweight silicone shell that includes a silicone layer containing pores.

[0007] According to one aspect, an artificial implant is provided comprising: a silicone shell; and a filler injected into the silicone shell; wherein the silicone shell comprises two or more first silicone layers forming the inner and outer surfaces of the silicone shell and one or more second silicone layers interposed between the two or more first silicone layers, and the second silicone layer comprises pores.

[0008] In one embodiment, the first silicone layer is obtained by drying and curing the first silicone compound, and the first silicone compound may comprise 50 to 90 parts by weight of xylene, 10 to 50 parts by weight of hexamethyldisylazane (1,1,1-trimethyl-N-(trimethylsilyl)-silanamine), and 0 to 10 parts by weight of polydimethylhydrogenmethylsiloxane (siloxanes and silicones, dimethyl, methyl hydrogen) based on 100 parts by weight of the total compound.

[0009] In one embodiment, the second silicone layer is obtained by drying and curing the second silicone compound, and the second silicone compound may comprise, based on 100 parts by weight of the total compound, 50 to 75 parts by weight of xylene, 10 to 40 parts by weight of hexamethyldisylazane (1,1,1-trimethyl-N-(trimethylsilyl)-silanamine), 0 to 10 parts by weight of octamethylcyclotetrasiloxane, 0 to 10 parts by weight of polydimethylhydrogenmethylsiloxane (Siloxanes and Silicones, dimethyl, methyl hydrogen), and 0 to 10 parts by weight of 2-methyl-3-butyn-2-ol.

[0010] In one embodiment, at least a portion of the silicon shell may be formed by stacking two or more first silicon layers and one or more second silicon layers in a continuous or alternating manner.

[0011] In one embodiment, the average pore size of the second silicon layer may be 1 to 500 μm.

[0012] In one embodiment, the average pore size of the second silicon layer may be 150 to 400 μm.

[0013] In one embodiment, the average pore size of the second silicon layer may be 200 to 350 μm.

[0014] In one embodiment, the average pore density of the second silicon layer may be 1 to 5 pores / mm2.

[0015] According to another aspect, (a) a step of forming a first silicone layer by coating a first silicone compound onto a breast-shaped mold, followed by drying and curing; (b) a step of forming pores by stirring a second silicone compound; (c) a step of forming a second silicone layer by coating the second silicone compound onto at least a portion of the breast-shaped mold on which the first silicone layer is formed, followed by drying and curing; and (d) a step of forming a first silicone layer by coating the first silicone compound on at least a portion of a breast-shaped mold part on which the second silicone layer is formed, and then drying and curing it; wherein the first silicone compound comprises, based on 100 parts by weight of the total compound, 50 to 90 parts by weight of xylene, 10 to 50 parts by weight of hexamethyldisylazane (1,1,1-trimethyl-N-(trimethylsilyl)-silanamine), and 0 to 10 parts by weight of polydimethylhydrogenmethylsiloxane (Siloxanes and Silicones, dimethyl, methyl hydrogen); and the second silicone compound comprises, based on 100 parts by weight of the total compound, 50 to 75 parts by weight of xylene, 10 to 40 parts by weight of hexamethyldisylazane (1,1,1-trimethyl-N-(trimethylsilyl)-silanamine), and octamethylcyclotetrasiloxane A method for manufacturing an artificial implant is provided, comprising 0 to 10 parts by weight of polydimethyl hydrogen methylsiloxane (Siloxanes and Silicones, dimethyl, methyl hydrogen), 0 to 10 parts by weight of 2-methyl-3-butyn-2-ol, and 0 to 10 parts by weight of 2-methyl-3-butyn-2-ol.

[0016] In one embodiment, steps (a) and (c) may each be repeated 1 to 10 times.

[0017] In one embodiment, steps (a) and (c) may each be performed alternately 1 to 10 times.

[0018] In one embodiment, the drying and curing process of step (a) may be performed at 40 to 60°C for 2 to 4 hours.

[0019] In one embodiment, the drying and curing process of step (c) may be performed at 80 to 200°C for 0.1 to 3 hours.

[0020] In one embodiment, the drying and curing process of step (d) may be performed at 40 to 60°C for 2 to 4 hours.

[0021] An artificial implant according to one aspect of the present invention has the advantage of having a relatively low density because it contains pores in the silicone layer, and thus has a light weight even with the same volume, which can minimize discomfort and foreign body sensation in the patient after implant insertion surgery.

[0022] The effects of one aspect of the present invention are not limited to the effects described above, and should be understood to include all effects that can be inferred from the configurations described in the detailed description of the invention or the claims of this specification.

[0023] Figure 1 is a schematic diagram of the lamination method for manufacturing an artificial implant according to the present invention.

[0024] Figure 2(a) is a schematic diagram of a conventional laminated structure artificial implant, and (b) is a schematic diagram of the laminated structure of the lightweight artificial implant of the present invention.

[0025] Figure 3 (a) is an embodiment of the present invention, and (b) is a photograph of a cross-section of an artificial implant representing a comparative example.

[0026] Figure 4 is a graph showing the mechanical properties of the artificial implants of the embodiments and comparative examples of the present invention.

[0027] [Explanation of the symbol]

[0028] 10 : Mold 11 : Load

[0029] 100: 1st silicon layer 200, 200': 2nd silicon layer

[0030] 110 : Patch section

[0031] Hereinafter, one aspect of the present specification will be described with reference to the attached drawings. However, the details described in the present specification may be implemented in various different forms and are therefore not limited to the embodiments described herein.

[0032] Throughout the specification, when a part is described as "including" a certain component, this means that, unless specifically stated otherwise, it does not exclude other components but rather allows for the inclusion of additional components.

[0033] When a range of numerical values ​​is described in this specification, unless a specific range is otherwise described, the value has the precision of significant figures provided according to the standard rules in chemistry for significant figures. For example, 10 includes a range of 5.0 to 14.9, and the number 10.0 includes a range of 9.50 to 10.49.

[0034] artificial implants

[0035] An artificial implant according to one aspect of the present invention comprises a silicone shell; and a filler injected into the silicone shell; wherein the silicone shell comprises two or more first silicone layers forming the inner and outer surfaces of the silicone shell, and one or more second silicone layers interposed between the two or more first silicone layers, and wherein the second silicone layer comprises pores.

[0036] Conventional artificial implants have the disadvantage of being heavier than human tissue even when having the same volume, because the density of the silicone shell is high. The artificial implant of the present invention is designed with a silicone layer in a multi-layer structure and includes pores in some of them to lower the density of the silicone shell, thereby achieving lightweighting, which can reduce the foreign body sensation and discomfort when inserted into a patient's body.

[0037] Looking at FIG. 1, it can be seen that a breast-shaped mold (10) is attached to a rod (11), and a first silicone layer (100) is first laminated on the surface of the mold (10) to form the inner surface of the silicone shell, then a second silicone layer (200) is laminated, and then the first silicone layer (100) is laminated again to form the outer surface of the silicone shell. At this time, the method of forming the first silicone layer (100) and the second silicone layer (200) is not limited to this.

[0038] Additionally, when separating the silicone shell from the mold (10), the silicone shell can be removed by opening the opening formed at the connection point between the mold (10) and the rod (11) and flipping the silicone shell over from the mold (10). Subsequently, the opening can be closed by bonding a patch portion (110) made of silicone material having the same elasticity and physical properties as the silicone shell.

[0039] Looking at FIG. 2, in the case of FIG. 2 (a), which is a structure that has been used conventionally, the second silicone layer (200') is simply laminated onto the first silicone layer (100). Even if the composition ratio of the first silicone layer and the second silicone layer is changed to make the physical properties different, there is a limit to weight reduction, and even if a lightweight material is used, there are limitations such as the structural stability deteriorating due to the large difference in physical properties. To overcome this, the structure of the present invention, which includes pores in the second silicone layer (200), is adopted. As a result, according to FIG. 2 (b), when the volume of the second silicone layer (200) is the same, a large number of pores are formed, thereby lowering the density of the artificial implant and securing a weight reduction effect. Furthermore, if silicone having a similar composition is used for the first silicone layer and the second silicone layer, structural stability can also be secured.

[0040] At this time, the first silicone layer has physical properties similar to conventional silicone and can perform the role of reinforcing the strength of the artificial implant inside and outside the artificial implant, and the first silicone layer can be obtained by drying and curing the shell of the first silicone mixture.

[0041] The above first silicone mixture may have a xylene content of 50 to 90 parts by weight per 100 parts by weight of the total mixture. For example, with respect to 100 parts by weight of the total mixture, the first silicone mixture has a xylene content of 50 parts by weight, 51 parts by weight, 52 parts by weight, 53 parts by weight, 54 parts by weight, 55 parts by weight, 56 parts by weight, 57 parts by weight, 58 parts by weight, 59 parts by weight, 60 parts by weight, 61 parts by weight, 62 parts by weight, 63 parts by weight, 64 parts by weight, 65 parts by weight, 66 parts by weight, 67 parts by weight, 68 parts by weight, 69 parts by weight, 70 parts by weight, 71 parts by weight, 72 parts by weight, 73 parts by weight, 74 parts by weight, 75 parts by weight, 76 parts by weight, 77 parts by weight, 78 parts by weight, 79 parts by weight, 80 parts by weight, 81 parts by weight, 82 parts by weight, 83 parts by weight, 84 parts by weight, 85 parts by weight, It may be 86 parts by weight, 87 parts by weight, 88 parts by weight, 89 parts by weight, 90 parts by weight, or a value between two of these values. If the content of xylene in the first silicone mixture falls outside the above range, the viscosity of the mixture may decrease, and the strength of the shell may decrease.

[0042] The first silicone compound above may contain 10 to 50 parts by weight of hexamethyldisylazane (1,1,1-trimethyl-N-(trimethylsilyl)-silanamine) per 100 parts by weight of the total compound. For example, with respect to 100 parts by weight of the total mixture, the first silicone formulation has a hexamethyldisylazane content of 10 parts by weight, 11 parts by weight, 12 parts by weight, 13 parts by weight, 14 parts by weight, 15 parts by weight, 16 parts by weight, 17 parts by weight, 18 parts by weight, 19 parts by weight, 20 parts by weight, 21 parts by weight, 22 parts by weight, 23 parts by weight, 24 parts by weight, 25 parts by weight, 26 parts by weight, 27 parts by weight, 28 parts by weight, 29 parts by weight, 30 parts by weight, 31 parts by weight, 32 parts by weight, 33 parts by weight, 34 parts by weight, 35 parts by weight, 36 parts by weight, 37 parts by weight, 38 parts by weight, 39 parts by weight, 40 parts by weight, 41 parts by weight, 42 parts by weight, 43 parts by weight, 44 parts by weight, It may be 45 parts by weight, 46 parts by weight, 47 parts by weight, 48 parts by weight, 49 parts by weight, 50 parts by weight, or a value between two of these values. If the content of the hexamethyldisylazane in the first silicone formulation falls outside the above range, the density of the manufactured artificial implant may become excessively high, and consequently, it may be difficult to lighten the weight of the artificial implant.

[0043] The first silicone compound may contain 0 to 10 parts by weight of polydimethyl hydrogen methylsiloxane (Siloxanes and Silicones, dimethyl, methyl hydrogen) with respect to 100 parts by weight of the total compound, preferably 2 to 8 parts by weight, and most preferably 3 to 7 parts by weight. For example, the first silicone compound may contain 0 parts by weight, 1 part by weight, 2 parts by weight, 3 parts by weight, 4 parts by weight, 5 parts by weight, 6 parts by weight, 7 parts by weight, 8 parts by weight, 9 parts by weight, 10 parts by weight, or a value between two of these values ​​with respect to 100 parts by weight of the total compound. If the content of the polydimethylhydrogenmethylsiloxane in the first silicone formulation falls outside the above range, the density of the manufactured artificial implant becomes excessively low, and the mechanical properties of the manufactured artificial implant may be degraded.

[0044] The second silicone layer above is an intermediate layer that can be formed between the first silicone layers, and can be obtained by stirring the second silicone mixture and then drying and curing it.

[0045] The second silicone layer formed in this way may have a lower density as it contains pores, and accordingly, if the second silicone layer is stacked multiple times, it may be easier to manufacture the lightweight artificial implant intended to be realized in the present invention.

[0046] The second silicone mixture may have a xylene content of 50 to 75 parts by weight with respect to 100 parts by weight of the total mixture. For example, the second silicone mixture may have a xylene content of 50 parts by weight, 51 parts by weight, 52 parts by weight, 53 parts by weight, 54 parts by weight, 55 parts by weight, 56 parts by weight, 57 parts by weight, 58 parts by weight, 59 parts by weight, 60 parts by weight, 61 parts by weight, 62 parts by weight, 63 parts by weight, 64 parts by weight, 65 parts by weight, 66 parts by weight, 67 parts by weight, 68 parts by weight, 69 parts by weight, 70 parts by weight, 71 parts by weight, 72 parts by weight, 73 parts by weight, 74 parts by weight, 75 parts by weight, or a value between two of these values. If the content of xylene in the second silicone mixture deviates from the above range, the viscosity of the second silicone mixture may be lowered, and accordingly, pores contained in the second silicone mixture may easily disappear.

[0047] The above second silicone compound may contain 10 to 40 parts by weight of hexamethyldisylazane (1,1,1-trimethyl-N-(trimethylsilyl)-silanamine) per 100 parts by weight of the total compound. For example, the second silicone formulation may have a content of hexamethyldisylazane of 10,000 parts by weight of the total formulation, 10,000 parts by weight, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40 parts by weight, or a value between two of these values. If the content of the hexamethyldisylazane in the second silicone formulation falls outside the above range, the density of the manufactured artificial implant may become excessively high, and consequently, it may be difficult to lighten the weight of the artificial implant.

[0048] The second silicone compound may contain 0 to 10 parts by weight of octamethylcyclotetrasiloxane with respect to 100 parts by weight of the total compound, preferably 2.5 to 8 parts by weight, and most preferably 4 to 7 parts by weight. For example, the second silicone compound may contain 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 parts by weight of octamethylcyclotetrasiloxane with respect to 100 parts by weight of the total compound, or a value between two of these values. If the content of octamethylcyclotetrasiloxane in the second silicone compound falls outside the above range, the density and viscosity of the second silicone compound may decrease, and accordingly, pores contained in the second silicone compound may easily disappear.

[0049] The second silicone compound may contain 0 to 10 parts by weight of polydimethyl hydrogen methylsiloxane (Siloxanes and Silicones, dimethyl, methyl hydrogen) with respect to 100 parts by weight of the total compound, preferably 2 to 8 parts by weight, and most preferably 3 to 7 parts by weight. For example, the second silicone compound may contain 0 parts by weight, 1 part by weight, 2 parts by weight, 3 parts by weight, 4 parts by weight, 5 parts by weight, 6 parts by weight, 7 parts by weight, 8 parts by weight, 9 parts by weight, 10 parts by weight, or a value between two of these values ​​with respect to 100 parts by weight of the total compound. If the content of the polydimethyl hydrogen methylsiloxane in the second silicone compound deviates from the above range, the density and viscosity of the second silicone compound may be lowered, and accordingly, the pores contained in the second silicone compound may easily disappear.

[0050] The second silicone compound may have a content of 2-methyl-3-butyn-2-ol of 0 to 10 parts by weight, preferably 0.5 to 7 parts by weight, more preferably 1 to 6 parts by weight, and most preferably 1.5 to 5 parts by weight, based on 100 parts by weight of the total compound. For example, the second silicone compound may have a content of 2-methyl-3-butyn-2-ol of 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 parts by weight, or a value between two of these values ​​based on 100 parts by weight of the total compound. If the content of 2-methyl-3-butane-2-ol in the second silicone compound deviates from the above range, the density and viscosity of the second silicone compound may be lowered, and accordingly, pores contained in the second silicone compound may easily disappear.

[0051] At least a portion of the above silicon shell may be formed by stacking two or more first silicon layers and one or more second silicon layers in a continuous or alternating manner. Here, “continuously” means that a plurality (e.g., 6 layers) of first silicon layers are stacked, a plurality (e.g., 5 layers) of second silicon layers are stacked thereon, and finally, a plurality (e.g., 3 layers) of first silicon layers are stacked thereon in sequence. Additionally, “alternating” means that, for example, a first silicon layer, a second silicon layer, a first silicon layer, a second silicon layer, a first silicon layer, a second silicon layer, and a first silicon layer are stacked sequentially, and in this case, it refers to a stack formed by alternating three times, or a stack formed by alternating three times.

[0052] The average pore size of the second silicon layer of the silicon shell may be 100 to 500 μm, preferably 150 to 400 μm, and most preferably 200 to 350 μm. If the average pore size of the second silicon layer falls outside the above range, the pores may not be maintained and may easily disappear, thereby degrading the mechanical properties of the second silicon layer.

[0053] The average pore density of the second silicon layer of the silicon shell may be 1 to 5 pores / mm2, preferably 1.5 to 4.5 pores / mm2, and most preferably 2 to 4 pores / mm2. If the average pore density of the second silicon layer falls outside the above range, the mechanical properties of the second silicon layer may deteriorate due to insufficient pores, or the density of the second silicon layer may increase due to excessive pore formation.

[0054] Method for manufacturing artificial implants

[0055] The method for manufacturing an artificial implant will be described in detail below. However, the description of parts within the same scope as the artificial implant will be omitted.

[0056] A method for manufacturing an artificial implant according to another aspect of the present invention comprises: (a) a step of forming a first silicone layer by coating a first silicone compound on a breast-shaped mold, drying, and curing it; (b) a step of forming pores by stirring a second silicone compound; (c) a step of forming a second silicone layer by coating the second silicone compound on at least a part of the breast-shaped mold on which the first silicone layer is formed, drying, and curing it; and (d) a step of forming a first silicone layer by coating the first silicone compound on the breast-shaped mold part formed on the second silicone layer, drying, and curing it.

[0057] Step (a) above is a step of manufacturing a silicone shell by coating a first silicone compound on a mold to form a first silicone layer and drying and curing it, and forming an inner layer of the silicone shell.

[0058] The drying and curing process of step (a) above may be performed at 40 to 60°C for 2 to 4 hours, and preferably, the drying and curing process of step (a) above may be performed at 50°C for 3 hours, but is not limited thereto.

[0059] Steps (b) and (c) above are steps of stirring the second silicone mixture to create pores, coating at least a portion of the inner layer of the silicone shell with the mixture, and drying and curing it to form a second silicone layer, thereby lowering the density of the artificial implant and making the weight lighter at the same volume.

[0060] The drying and curing process of step (c) above may be performed at 80 to 200°C for 0.1 to 3 hours, and preferably, the drying and curing process of step (c) above may be performed at 150°C for 1 hour, but is not limited thereto.

[0061] Steps (a) and (c) above may each be repeated 1 to 10 times. For example, Step (a) above may be repeated 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times, and depending on the number of repetitions of Step (a), the first silicon layer may be stacked as 1 layer, 2 layers, 3 layers, 4 layers, 5 layers, 6 layers, 7 layers, 8 layers, 9 layers, or 10 layers. In addition, the above step (c) may be repeated 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times, and depending on the number of repetitions of the above step (c), the second silicon layer may be stacked as 1 layer, 2 layers, 3 layers, 4 layers, 5 layers, 6 layers, 7 layers, 8 layers, 9 layers, or 10 layers.

[0062] Steps (a) and (c) above may each be performed alternately 1 to 10 times. For example, steps (a) and (c) above may be performed alternately 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times, and steps (a) and (c) above may be performed repeatedly and then alternately again. For example, step (a) above may be performed repeatedly 2 times first, and then step (c) above may be performed repeatedly 3 times.

[0063] Step (d) above is a step of coating the first silicone formulation on at least a portion of the breast-shaped mold part on which the second silicone layer is formed, and drying and curing to finally form the first silicone layer, thereby forming the outer layer of the silicone shell used in the artificial implant of the present invention. Accordingly, the mechanical properties of the artificial implant of the present invention, particularly the fracture strength and elongation rate, can be excellent.

[0064] The drying and curing process of step (d) above may be performed at 40 to 60°C for 2 to 4 hours, and preferably, the drying and curing process of step (d) above may be performed at 50°C for 3 hours, but is not limited thereto.

[0065] The embodiments of this specification will be described in more detail below. However, the following experimental results represent only representative results among the above embodiments, and the scope and content of this specification should not be interpreted as being narrowed or limited by the embodiments. The effects of each of the various embodiments of this specification not explicitly presented below will be described in detail in the relevant sections.

[0066] Example 1

[0067] First, a teardrop-shaped or round mold was prepared and immersed in a first silicone formulation having the content ratios shown in Table 1 below to form a first silicone layer. Subsequently, the mold was dried at 50°C for 2 hours, and this process was repeated twice to produce a silicone shell. Next, a second silicone formulation having the content ratios shown in Table 2 below was prepared and stirred at a speed of 50 rpm for 1 hour to form bubbles within the formulation. Then, the second silicone formulation with the formed bubbles was applied to the silicone shell to laminate the second silicone layer. At this time, the shell was first dried at 100°C for 15 minutes and secondly dried at 150°C for 2 hours, and this process was repeated three times to laminate the second silicone layer three times. Finally, the first silicone formulation was applied and laminated onto the dried shell, the shell was dried at 50°C for 2 hours, and this process was repeated twice, followed by curing at 150°C for 2 hours to finally obtain an artificial implant with a volume of 150cc.

[0068] Comparative Example 1

[0069] An artificial implant was manufactured in a manner similar to the above example, but without performing the stirring process of the second silicone mixture, and the content ratio of the second silicone mixture was set as shown in Table 2 below to finally obtain an artificial implant having a volume of 150cc.

[0070] Composition Ratio Example 1 Comparative Example 1 Xylene 70 70 Hexamethyldisylazane 25 25 Polydimethyl hydrogenmethylsiloxane 55

[0071] Composition Ratio Example 1 Comparative Example 1 Xylene 6579 Hexamethyldisylazane 2115 Polydimethyl hydrogenmethylsiloxane 53 Octamethylcyclotetrasiloxane 622-methyl-3-butane-2-ol 31

[0072] Experimental Example 1: Analysis of the Shell Cross-section of an Artificial Implant

[0073] In order to confirm whether the pores formed in the second silicone layer of the artificial implants manufactured in the above examples and comparative examples are visible to the naked eye, the artificial implants of the examples and comparative examples were cut and their cross-sections were photographed and shown in FIG. 3.

[0074] Referring to FIG. 3, it was confirmed that Example 1 of (a), which includes pores, contains pores inside, whereas Comparative Example 1 of (b), which does not form separate pores, has a smooth shell cross-section and no pores are observed.

[0075] To analyze the pore formation effect more closely, the pore particle size analysis of Experimental Example 2 below was performed.

[0076] Experimental Example 2: Analysis of Pore Size of Artificial Implants

[0077] In order to determine the degree of pore formation in the second silicone layer of the artificial implant manufactured in the example, particle size analysis was performed on the second silicone layer in 10 Example 1s manufactured in the same manner. Using a particle size analyzer with light scattering, the pore size and density were measured and recorded in accordance with ASTM E2834-12.

[0078] As a result, the average pore size was found to be 278 μm with a standard deviation of 38, and the average pore density was found to be 3.6 pores / mm² with a standard deviation of 0.4. Therefore, it was confirmed that a large number of microbubbles were formed and maintained in the actual second silicon layer, thereby performing the function of lowering the density of the silicon layer.

[0079] In addition, to evaluate the level of mechanical properties of the manufactured artificial implant, the mechanical property evaluation of Experimental Example 3 below was conducted.

[0080] Experimental Example 3: Evaluation of Mechanical Properties of Artificial Implants

[0081] The elongation and breaking strength (ASTM D412) of each of the 10 artificial implants manufactured in the examples and comparative examples were measured using a Universal Testing Machine.

[0082] First, three rectangular pieces were cut from the base (the posterior lateral part when implanted in the patient), the equator (the part with the largest diameter), and the apex (the anterior lateral part when implanted in the patient) of the outer surface of the artificial implant and measured, and the mean value and standard deviation of the measured results are shown in Figure 4 below.

[0083] Referring to Fig. 4, it can be seen that Example 1 satisfies both the fracture strength of 12N and the elongation of 350%, which are the lower limits of the physical properties of the existing shell, thus confirming that the mechanical properties of the manufactured artificial implant are maintained at a similar level even though the density has been reduced. In addition, to confirm the weight reduction effect of the artificial implant of the present invention, the experiment of Experimental Example 3 below was conducted.

[0084] Experimental Example 4: Evaluation of Lightweight Properties of Artificial Implants

[0085] The weight of each of the 10 artificial implants manufactured in the examples and comparative examples was measured, and the average along with the standard deviation is shown in Table 3 below.

[0086] Example 1 Comparative Example 1 Weight (g) 9.1 1.7 Standard deviation 0.2 0.5

[0087] Referring to Table 3, it can be confirmed that in Example 1, the second silicone layer contains pores, and as the density of the silicone shell decreases, the weight is reduced, resulting in a weight of 10g or less for an implant with a volume of 150cc. Additionally, the standard deviation is small, indicating that the weight is uniform during the manufacture of the artificial implant. On the other hand, in the case of Comparative Example 1, no separate pores were included, so the density of the silicone shell was maintained at a high level. Consequently, an implant with a volume of 150cc showed a weight exceeding 10g, which could cause discomfort and a foreign body sensation in the patient after implant insertion surgery. Therefore, it can be confirmed that the artificial implant of the present invention can reduce patient discomfort and a foreign body sensation as the weight is reduced. The foregoing description of this specification is for illustrative purposes only, and those skilled in the art to which one aspect of this specification belongs will understand that other specific forms can be easily modified without changing the technical concept or essential features described in this specification. Therefore, the embodiments described above should be understood as exemplary in all respects and not limiting. For example, each component described as a single unit may be implemented in a distributed manner, and likewise, components described as distributed may be implemented in a combined form.

[0088] The scope of this specification is defined by the claims set forth below, and all modifications or variations derived from the meaning and scope of the claims and equivalent concepts thereof should be interpreted as being included within the scope of this specification.

Claims

1. Silicon shell; and It includes a filler injected into the interior of the above silicone shell, and The above silicon shell comprises two or more first silicon layers forming the inner and outer surfaces of the silicon shell, and one or more second silicon layers interposed between the two or more first silicon layers. The above second silicone layer is an artificial implant comprising pores.

2. In Paragraph 1, The first silicone layer is obtained by drying and curing the first silicone compound, and The above first silicone formulation comprises, based on 100 parts by weight of the total formulation, 50 to 90 parts by weight of xylene, 10 to 50 parts by weight of hexamethyldisylazane (1,1,1-trimethyl-N-(trimethylsilyl)-silanamine), and 0 to 10 parts by weight of polydimethylhydrogenmethylsiloxane (siloxanes and silicones, dimethyl, methyl hydrogen), an artificial implant.

3. In Paragraph 1, The second silicone layer is obtained by drying and curing the second silicone compound, and The above second silicone formulation comprises, based on 100 parts by weight of the total formulation, 50 to 75 parts by weight of xylene, 10 to 40 parts by weight of hexamethyldisylazane (1,1,1-trimethyl-N-(trimethylsilyl)-silanamine), 0 to 10 parts by weight of octamethylcyclotetrasiloxane, 0 to 10 parts by weight of polydimethylhydrogenmethylsiloxane (Siloxanes and Silicones, dimethyl, methyl hydrogen), and 0 to 10 parts by weight of 2-methyl-3-butyn-2-ol.

4. In Paragraph 1, An artificial implant in which at least a portion of the above silicone shell is formed by stacking two or more first silicone layers and one or more second silicone layers in a continuous or intersecting manner.

5. In Paragraph 1, An artificial implant having an average pore size of 1 to 500 μm in the second silicone layer.

6. In Paragraph 1, An artificial implant having an average pore size of 150 to 400 μm in the second silicone layer.

7. In Paragraph 1, An artificial implant having an average pore size of 200 to 350 μm in the second silicone layer.

8. In Paragraph 1, An artificial implant having an average pore density of 1 to 5 pores / mm² of the second silicone layer.

9. (a) A step of forming a first silicone layer by coating a first silicone formulation onto a breast-shaped mold, and then drying and curing it; (b) a step of stirring the second silicone mixture to form pores; (c) a step of forming a second silicone layer by coating a second silicone compound with the pores formed therein onto at least a portion of a breast-shaped mold having the first silicone layer formed thereon, and then drying and curing it; and (d) a step of forming a first silicone layer by coating the first silicone compound on at least a portion of the breast-shaped mold part on which the second silicone layer is formed, and then drying and curing it; The first silicone formulation comprises, based on 100 parts by weight of the total formulation, 50 to 90 parts by weight of xylene, 10 to 50 parts by weight of hexamethyldisylazane (1,1,1-trimethyl-N-(trimethylsilyl)-silanamine), and 0 to 10 parts by weight of polydimethylhydrogenmethylsiloxane (siloxanes and silicones, dimethyl, methyl hydrogen). The second silicone formulation comprises, based on 100 parts by weight of the total formulation, 50 to 75 parts by weight of xylene, 10 to 40 parts by weight of hexamethyldisylazane (1,1,1-trimethyl-N-(trimethylsilyl)-silanamine), 0 to 10 parts by weight of octamethylcyclotetrasiloxane, 0 to 10 parts by weight of polydimethylhydrogenmethylsiloxane (Siloxanes and Silicones, dimethyl, methyl hydrogen), and 0 to 10 parts by weight of 2-methyl-3-butyn-2-ol. Method of manufacturing an artificial implant.

10. In Paragraph 9, A method for manufacturing an artificial implant, characterized in that steps (a) and (c) are each repeated 1 to 10 times.

11. In Paragraph 9, A method for manufacturing an artificial implant, characterized in that steps (a) and (c) are each performed alternately 1 to 10 times.

12. In Paragraph 9, A method for manufacturing an artificial implant, characterized in that the drying and curing process of step (a) above is performed at 40 to 60°C for 2 to 4 hours.

13. In Paragraph 9, A method for manufacturing an artificial implant, characterized in that the drying and curing process of step (c) above is performed at 80 to 200°C for 0.1 to 3 hours.

14. In Paragraph 9, A method for manufacturing an artificial implant, characterized in that the drying and curing process of step (d) above is performed at 40 to 60°C for 2 to 4 hours.

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