Artificial implant and its manufacturing method

Abstract

An artificial implant and a method for manufacturing the same are disclosed, which include: a silicone shell having an upper portion, a lower portion, and a side portion; and a filler injected into the silicone shell; the silicone shell includes one or more silicone layers and one or more reinforcing layers formed on at least a portion of a surface of the silicone layer, the reinforcing layers being provided on at least a portion of the lower portion and the side portion of the silicone shell; or the silicone shell includes a layered structure having steps formed therein.

Description

[Technical field]

[0001] The present specification relates to a highly stable artificial implant and a method for producing the same. [Background technology]

[0002] Breast implants are class 4 medical devices in which the silicone shell that forms the outer covering of the implant is filled with gel or saline of appropriate viscosity, and require special biological stability in the body. The implant industry has secured the required physical properties for medical devices by adjusting the thickness of the silicone shell or changing the ingredients of the filling, and in general, research and development is underway to adjust the physical properties of the filling to achieve a natural shape.

[0003] However, artificial implants still have the potential risk of side effects after implantation. In particular, the rippling phenomenon occurs frequently due to the folding of the silicone shell. Rippling is a side effect in which wrinkles formed on the surface of the implant appear as a wavy pattern on the skin surface of the chest. Not only does it reduce the aesthetic satisfaction of the user, but it also reduces the durability of the area due to the continuous folding of a specific part of the silicone shell, which is the outer cover of the implant, and can lead to the rupture of the implant.

[0004] When an artificial implant ruptures, the filling material inside the implant may leak out. The leakage of the filling material may cause an inflammatory reaction inside the human body, which may then induce tissue necrosis, bacterial infection, capsular contracture, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), etc., which may cause severe pain to the user due to an oversensitive immune reaction. In particular, users who experience capsular contracture must undergo reoperation, and users who experience BIA-ALCL may be at risk of death.

[0005] In order to solve the above problems of the conventional artificial implants, it is most important to prevent the implant from bursting. In particular, the rippling phenomenon occurs continuously only in a specific area of ​​the silicone shell, which is the outer cover of the implant, and the durability is reduced, so there is a need to develop an artificial implant that can impart mechanical properties to the specific area and a method for manufacturing the same. Summary of the Invention [Problem to be solved by the invention]

[0006] SUMMARY OF THE PRESENTLY PREFERRED EMBODIMENTS In order to overcome the above-mentioned problems of the prior art, it is an object of the present invention to provide an artificial implant and a method for manufacturing the same that have excellent mechanical stability and prevent rupture. [Means for solving the problem]

[0007] According to one aspect, a silicon shell having an upper portion, a lower portion, and a side portion; and a filler injected into the silicon shell, the silicon shell including one or more silicon layers and one or more reinforcing layers formed on at least a portion of a surface of the silicon layer, the reinforcing layers being provided on at least a portion of the lower portion and the side portion of the silicon shell. The reinforcing layer is laminated on the surface of the silicon layer to form a layered structure having a step on the outer surface of the silicon shell. An artificial implant is provided.

[0008] According to another aspect, there is provided an artificial implant comprising: a silicone shell having an upper portion, a lower portion, and a side portion; and a filler injected into the silicone shell; the silicone shell comprising one or more silicone layers and one or more reinforcing layers formed on at least a portion of a surface of the silicone layer, the silicone shell comprising a layered structure having steps.

[0009] In one embodiment, at least a portion of the silicone shell may be formed by one or more of the silicone layers and one or more of the reinforcing layers being continuous or intersecting.

[0010] In one embodiment, the silicone shell may have a thickness of 0.4 to 1.2 mm, and the reinforcing layer may have a thickness of 0.01 to 0.3 mm.

[0011] In one embodiment, the thickness of the upper and lower portions of the silicon shell may be 0.4 to 0.8 mm, and the thickness of the reinforced side portion of the silicon shell may be 0.4 to 1.2 mm.

[0012] In one embodiment, the portion of the silicone shell having the reinforcing layer may satisfy at least one of the following conditions (i) to (ii): (i) burst strength of 25 to 50 N; (ii) elongation of 400 to 520%.

[0013] In one embodiment, the cross-sectional shape of the artificial implant may be selected from the group consisting of a circular, an oval, and a teardrop.

[0014] According to another aspect, the method includes the steps of: (a) immersing a breast-shaped mold in a silicone solution to form one or more silicone layers; (b) applying the silicone solution to at least a portion of the silicone layer to form one or more reinforcing layers; (c) drying and hardening the formed silicone layer and reinforcing layer to manufacture a silicone shell; (d) forming an injection groove to inject a filler into an internal space of the silicone shell; and (e) injecting the filler through the injection groove. The reinforcing layer is provided on at least a part of the lower portion and the side portion of the silicon shell, and the reinforcing layer is laminated on the surface of the silicon layer to form a layered structure having a step on the outer surface of the silicon shell. A method for producing an artificial implant is provided.

[0015] In an embodiment, in step (b), the reinforcing layer may be formed on at least a portion of the bottom and side portions of the silicon shell.

[0016] In an embodiment, the reinforcing layer may be formed in step (b) such that the silicone shell has a layered structure having steps.

[0017] In one embodiment, each of steps (a) and (b) may be repeated 1 to 10 times.

[0018] In one embodiment, the steps (a) and (b) may be crossed 1 to 10 times, respectively. Effect of the Invention

[0019] According to one aspect, an artificial implant and a manufacturing method thereof can be provided that have excellent durability and resistance to bursting by reinforcing mechanically weak points, and thus can prevent folding and the resulting bursting or damage.

[0020] The effects of one aspect of this specification are not limited to the effects described above, but should be understood to include all effects that can be inferred from the configurations described in the detailed description or claims of this specification. [Brief description of the drawings]

[0021] [Figure 1]FIG. 1 is a cross-sectional view of a reinforced underside prosthetic implant according to one embodiment of the present disclosure. [Diagram 2] FIG. 2 is a cross-sectional view of a reinforced underside prosthetic implant according to yet another embodiment of the present disclosure. [Diagram 3] FIG. 3 is a cross-sectional view of a side-reinforced prosthetic implant according to another embodiment of the present disclosure. [Figure 4] FIG. 4 is a cross-sectional view of a side-reinforced prosthetic implant according to yet another embodiment of the present disclosure. [Diagram 5] FIG. 5 is a cross-sectional view of a prosthetic implant with reinforced bottom and sides according to another embodiment of the present disclosure. [Figure 6] FIG. 6 is a cross-sectional view of a prosthetic implant having reinforced bottom and sides in accordance with another embodiment of the present disclosure. [Figure 7] FIG. 7 is a schematic diagram of a layered structure at the end of a reinforcing structure of a prosthetic implant according to one embodiment of the present disclosure. [Figure 8] FIG. 8 is a schematic diagram of a layered structure at the end of a reinforcing structure of an artificial implant according to yet another embodiment of the present disclosure. [Figure 9] FIG. 9 is an elongation graph of the examples and comparative examples of this specification. [Figure 10] FIG. 10 is a burst strength graph of the examples and comparative examples herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] Hereinafter, an aspect of the present specification will be described with reference to the accompanying drawings. However, the description of the present specification may be embodied in various different forms. Therefore, the present specification is not limited to the embodiments described herein. In addition, in order to clearly describe an aspect of the specification in the drawings, parts that are not related to the description are omitted, and similar parts are designated by similar reference numerals throughout the specification.

[0023] Throughout the specification, the term "connected" to another part includes not only "directly connected" but also "indirectly connected" with another member therebetween. In addition, the term "comprises" a certain component means that the part can further include the other component, not excluding the other component, unless otherwise specified.

[0024] When a range of numerical values ​​is recited herein, unless a specific range thereof is stated to the contrary, the values ​​have the precision of significant figures provided by standard rules in chemistry for significant figures, for example, the number 10 includes a range of 5.0 to 14.9, and the number 10.0 includes a range of 9.50 to 10.49.

[0025] Hereinafter, an embodiment of the present specification will be described in detail with reference to the accompanying drawings.

[0026] Artificial implants According to one aspect, the artificial implant 100 includes a silicone shell having an upper portion 110, a lower portion 120, and a side portion 130; and a filler injected into the silicone shell; the silicone shell includes one or more silicone layers and one or more reinforcing layers, which may be provided on at least a portion of the lower portion 120 and the side portion 130 of the silicone shell. The reinforcing layer provided on at least a portion of the silicone shell may form a reinforcing structure 140 to improve the stability of the artificial implant 100.

[0027] According to another aspect, an artificial implant 100 is provided, which includes a silicone shell having an upper portion 110, a lower portion 120, and a side portion 130; and a filler injected into the silicone shell, the silicone shell including one or more silicone layers and one or more reinforcing layers formed on at least a portion of a surface of the silicone layer, the silicone shell including a layered structure having a step. The reinforcing layer formed on at least a portion of a surface of the silicone layer forms a reinforcing structure 140, which can improve the stability of the artificial implant 100.

[0028] Conventional artificial implants are manufactured by forming a silicone shell with the same thickness in all areas and then injecting a filler into the inside. When this is inserted into the human body, the shell may easily fold in a specific area due to the physical properties of the gel and gravity. For example, conventional artificial implants frequently fold in the side areas. When the shell folds while the artificial implant is inserted into the body, it causes a rippling phenomenon that appears wavy on the chest surface, and the physical properties of the side areas are reduced, making the silicone shell easily damaged. The artificial implant 100 according to one aspect of the present specification can improve these problems by improving durability and resistance to rupture.

[0029] The silicone shell may be formed by laminating one or more silicone layers. For example, at least a portion of the lower portion 120 and the side portion 130 may be formed by laminating one or more silicone layers and one or more reinforcing layers. A filler may be injected into the silicone shell to maintain the shape of the artificial implant 100.

[0030] As an example, Fig. 1 and Fig. 2 are views showing the artificial implant 100 in which a reinforcing layer is provided on the lower part 120 of the silicon shell to form a reinforcing structure 140, Fig. 3 and Fig. 4 are views showing the artificial implant 100 in which a reinforcing layer is provided on the side part 130 of the silicon shell to form a reinforcing structure 140, and Fig. 5 and Fig. 6 are views showing the artificial implant 100 in which a reinforcing layer is provided on the lower part 120 and the side part 130 of the silicon shell to form a reinforcing structure 140. In this way, the artificial implant 100 may have a reinforcing structure 140 in which one or more reinforcing layers are provided on a part of the silicon shell according to a required purpose. In this way, the reinforcing structure 140 improves the durability and resistance to bursting of the artificial implant 100, and prevents folding.

[0031] The end of the reinforcing structure 140 may include a layered structure having a step. As a non-limiting example, the silicone shell may include 1 to 10 reinforcing layers, for example, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or a range between any two of these values. The shape of the layered structure may be different depending on the target artificial implant 100 product. As an example, when a layered structure having a step of a multi-layered stepped structure is included, stress concentration can be prevented and usability can be improved. As another example, when a layered structure having a step of a fault structure is included, the strength of the reinforced portion can be uniformly improved. Such a reinforcing structure 140 may be formed on at least a part of the upper part, lower part, and side part of the silicone shell.

[0032] Figures 1, 3 and 5 show a gradual layer structure A formed in a stepped structure of two or more layers. By forming such a gradual layer structure with a gentle end without abrupt thickness difference, it is possible to prevent stress concentration and improve usability.

[0033] 2, 4 and 6 are diagrams showing a layer structure B formed in a one-layer stepped structure. By forming such a layer structure with steps, the strength of the area to be reinforced can be uniformly improved.

[0034] The one or more silicone layers and the one or more reinforcing layers forming the above-mentioned reinforcing structure 140 of the silicone shell can be formed in a continuous or crossed manner. Such reinforcing structure 140 can be freely selected according to the desired properties of the final product.

[0035] For example, Fig. 7 shows a structure in which a silicone layer and a reinforcing layer are formed successively. That is, a first silicone layer 11, a second silicone layer 12, a third silicone layer 13, a first reinforcing layer 21, a second reinforcing layer 22, and a third reinforcing layer 23 can be formed in sequence to manufacture an artificial implant having the structure of Fig. 7. Such a structure may be relatively easy to manufacture.

[0036] As another example, Fig. 8 shows a structure in which a silicone layer and a reinforcing layer are crossed. That is, a first silicone layer 11, a first reinforcing layer 21, a second silicone layer 12, a second reinforcing layer 22, a third silicone layer 13, a third reinforcing layer 23, and a fourth silicone layer 14 can be formed in sequence to manufacture an artificial implant having the structure of Fig. 8. In this structure, the silicone layer surrounds each end of the reinforcing layer, which can prevent the reinforcing layer from falling off.

[0037] The artificial implant may have a uniform thickness in all regions, or the thickness of the region having the reinforcing structure 140 may be greater than the other regions. If the thickness of all regions is uniform, the composition of the reinforcing layer may be different to improve the mechanical stability of the artificial implant. If the thickness varies depending on the region, the composition of the silicone layer and the reinforcing layer may be the same or different depending on the purpose.

[0038] The silicone shell may have a thickness of 0.4 to 1.2 mm, and the reinforcing layer may have a thickness of 0.01 to 0.3 mm. As an example, the thickness of the portion not provided with the reinforcing structure 140 may be 0.4 to 0.8 mm, for example, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, or any range therebetween, but is not limited thereto. In this example, the region provided with the reinforcing structure 140 may have a thickness of 0.4 to 1.2 mm, for example, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, or any range therebetween, but is not limited thereto. If the thickness of the reinforcing structure 140 of the silicone shell is less than 0.4 mm, the mechanical properties may be reduced, which may cause damage to the artificial implant 100 and aesthetic side effects, and if it exceeds 1.2 mm, it may cause discomfort such as a foreign body sensation to the user who has received the artificial implant 100. The thickness may include the thickness of the silicone layer or the thickness of the silicone layer and the thickness of the reinforcing layer depending on the region. The thickness of the reinforcing layer may be 0.01 to 0.3 mm, for example, 0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.1 mm, 0.11 mm, 0.12 mm, 0.13 mm, 0.14 mm, 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, 0.2 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, 0.25 mm, 0.26 mm, 0.27 mm, 0.28 mm, 0.29 mm, 0.3 mm, or a range therebetween, but is not limited thereto. If the thickness of the reinforcing layer is less than 0.01 mm, the stability of the reinforcing structure 140 may decrease, and if it exceeds 0.3 mm, the thickness deviation between each region of the silicone shell may be excessive, resulting in reduced durability due to stress concentration. The thickness of each reinforcing layer may vary depending on the thickness of the reinforcing structure 140 and the number of layers forming the reinforcing structure 140. By stacking a large number of reinforcing layers with relatively thin thicknesses, the foreign body sensation felt by the user may be minimized, and by using a small number of thick reinforcing layers, convenience in manufacturing may be excellent.

[0039] As another example, the thickness of the upper part 110 and the lower part 120 of the silicone shell may be 0.4 to 0.8 mm, for example, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, or a range therebetween, but is not limited thereto. If the thickness of the upper part 110 and the lower part 120 of the silicone shell is less than 0.4 mm, the durability of the silicone shell may decrease and it may burst even with a small stimulus, and if it exceeds 0.8 mm, it may cause inconvenience such as a foreign body sensation to the user who has received the artificial implant 100. In addition, the thickness of the reinforced side part 130 of the silicone shell may be 0.4 to 1.2 mm, for example, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, or a range therebetween, but is not limited thereto. If the side portion 130 of the silicon shell is less than 0.4 mm, the physical properties of the side portion 130 of the silicon shell may be reduced, causing damage to the artificial implant 100 and aesthetic side effects, and if it exceeds 1.2 mm, the side portion 130 may be too thick, causing discomfort such as a foreign body sensation to a user who has received the artificial implant 100. The thickness of the reinforced side portion may include the thickness of the silicon layer and the thickness of the reinforcing structure 140.

[0040] Meanwhile, the portion of the silicone shell having the reinforcing layer may satisfy at least one of the following conditions (i) to (ii): (i) burst strength of 25 to 50 N; (ii) elongation of 400 to 520%.

[0041] For example, the burst strength of the portion of the silicone shell having the reinforcing layer may be, but is not limited to, 25N, 26N, 27N, 28N, 29N, 30N, 31N, 32N, 33N, 34N, 35N, 36N, 37N, 38N, 39N, 40N, 41N, 42N, 43N, 44N, 45N, 46N, 47N, 48N, 49N, 50N, or a range therebetween. The silicone shell forming the outer cover of the artificial implant 100 may have enhanced durability and burst resistance of the shell due to the reinforcing layer, and thus may have a burst strength ranging from 25 to 50N.

[0042] In addition, the elongation of the portion of the silicone shell having the reinforcing layer may be, for example, but not limited to, 400%, 410%, 420%, 430%, 440%, 450%, 460%, 470%, 480%, 490%, 500%, 510%, 520%, or a range therebetween. If the elongation is less than 400%, the texture and feel of the silicone shell may be deteriorated, which may reduce the preference of users, and if it exceeds 520%, the artificial implant 100 may be easily damaged or ruptured.

[0043] The artificial implant may have different shapes depending on the insertion site or the purpose of the surgery, and may be inserted into many body sites, such as the breast, nose, buttocks, forehead, and hips, but the shape is not particularly limited.

[0044] As a non-limiting example, the artificial implant 100 can function as an implant in the body by inserting a filler into the silicone shell, and the filler may be silicone gel, and the silicone gel may be an organosiloxane polymer (polyorganosiloxane). The organosiloxane polymer may be one selected from the group consisting of dimethylsiloxane, methylhydrogensiloxane, methylphenylsiloxane, diphenylsiloxane, dimethylvinylsiloxane, tri-fluoropropylsiloxane, and a mixture of two or more of these, but the type is not particularly limited as long as the functional characteristics of the artificial implant can be realized.

[0045] The cross-sectional shape of the artificial implant may be one selected from the group consisting of a circle, an oval, and a teardrop, but is not limited thereto. Generally, since the shape and form of the breast of each user is different, the type of the artificial implant can be selected in consideration of the original shape and the user's preference of the shape, form, size, etc.

[0046] Method for manufacturing artificial implants According to another aspect, a method for manufacturing an artificial implant may include: (a) immersing a breast-shaped mold in a silicone solution to form one or more silicone layers; (b) applying the silicone solution to at least a portion of the silicone layer to form one or more reinforcing layers; (c) drying and curing the formed silicone layer and reinforcing layer to form a silicone shell; (d) forming an injection groove to inject a filler into an internal space of the silicone shell; and (e) injecting the filler through the injection groove.

[0047] The silicone shell forming the outer covering of the artificial implant can be manufactured by the steps (a) to (c). As described above, the silicone shell can be composed of an upper portion 110, a lower portion 120, and a side portion 130, and the silicone shell can include one or more silicone layers and one or more reinforcing layers, and the reinforcing layers can be provided on at least a portion of the lower portion and side portion of the silicone shell, or the silicone shell can include a layered structure having a step to increase the thickness, thereby improving the stability of the artificial implant.

[0048] For example, the reinforcing layer may be formed on at least a portion of the lower and side portions of the silicon shell in step (b), or the reinforcing layer may be formed such that the silicon shell has a layered structure having a step in step (b), and the layered structure having a step may be formed on at least a portion of the upper, lower, and side portions of the silicon shell.

[0049] The steps (a) and (b) may be independently repeated 1 to 10 times. For example, the step (a) may be repeated 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times, and the silicon layer may be laminated in 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 layers depending on the number of times the step (a) is repeated. In addition, the step (b) may be repeated 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times, and the reinforcing layer may be laminated in 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 layers depending on the number of times the step (b) is repeated, but is not limited thereto. For example, an artificial implant manufactured by repeating the steps (a) and (b) three times each may be manufactured in the shape of FIG. 7. Referring to Fig. 7, the artificial implant may be formed by sequentially forming a first silicon layer 11, a second silicon layer 12, and a third silicon layer 13, and a first reinforcing layer 21, a second reinforcing layer 22, and a third reinforcing layer 23 on at least a portion of the surface of the third silicon layer 13. When the reinforcing layers are formed in a stepped layered structure with gentle steps as in the first to third reinforcing layers 21, 22, and 23 of Fig. 7, a gradual layered structure is formed, and stress concentration can be further alleviated. When each reinforcing layer is formed in a form without steps (not shown), an artificial implant having a reinforcing structure 140 can be easily manufactured without additional operations during the formation of each layer.

[0050] Meanwhile, the steps (a) and (b) may be independently performed 1 to 10 times. For example, an artificial implant manufactured by performing the step (a) 4 times and the step (b) 3 times may be manufactured in the shape of FIG. 8. Referring to FIG. 9, the artificial implant may be formed by performing the steps (a) and (b) once each, and may sequentially form a first silicon layer 11, a first reinforcing layer 21, a second silicon layer 12, a second reinforcing layer 22, a third silicon layer 13, a third reinforcing layer 23, and a fourth silicon layer 14. By forming the silicon layers and reinforcing layers in this manner, a stepped layered structure having steps may be easily realized.

[0051] In this manner, the thickness of the layered structure can be controlled by adjusting the number of times steps (a) to (b) are repeated, and the reinforcing structure 140 can be formed on at least a portion of the upper portion 110, the lower portion 120, and the side portion 130 by adjusting the immersion and coating area.

[0052] In step (d), an injection groove may be formed to inject a filler into the inner space of the silicon shell. The injection groove may serve to inject a filler into the interior of the silicon shell and to close the injection groove after the injection to prevent the injected filler from leaking out.

[0053] In step (e), the filler may be injected through the injection groove to manufacture the artificial implant. As a non-limiting example, the artificial implant may function as an implant in the body by injecting a filler into the silicone shell, and the filler may be silicone gel, and the silicone gel may be an organosiloxane polymer. The organosiloxane polymer may be one selected from the group consisting of dimethylsiloxane, methylhydrogensiloxane, methylphenylsiloxane, diphenylsiloxane, dimethylvinylsiloxane, tri-fluoropropylsiloxane, and a mixture of two or more of these, but the type is not particularly limited as long as the functional characteristics of the artificial implant can be realized. In addition, the insertion site, shape, cross-sectional shape, etc. of the artificial implant can be selected in consideration of the user's preference for shape, pattern, size, etc., and the detailed technical matters are as described above.

[0054] The examples of the present specification will be described in more detail below. However, the following experimental results are only representative experimental results among the above examples, and the scope and contents of the present specification should not be construed as being narrowed or limited by the examples. The respective effects of the various embodiments of the present specification that are not explicitly presented below will be specifically described in the relevant parts.

[0055] Example 1 The breast-shaped mold was immersed in the silicone solution three times to sequentially form the first, second and third silicone layers, which were then laminated to a uniform thickness of 0.5 mm. The silicone solution was applied to the side of the third silicone layer, and the first reinforcing layer was laminated to produce a silicone shell with a step. An artificial implant was produced by inserting a filler into the silicone shell.

[0056] Example 2 The breast-shaped mold was immersed in the silicone solution three times to sequentially form the first, second and third silicone layers, which were then laminated to a uniform thickness of 0.5 mm. The silicone solution was applied to the side of the third silicone layer, and the first and second reinforcing layers were laminated to produce a silicone shell with a step. An artificial implant was produced by injecting a filler into the silicone shell.

[0057] Example 3 The breast-shaped mold was immersed in the silicone solution three times to sequentially form the first, second and third silicone layers, which were then laminated to a uniform thickness of 0.5 mm. The silicone solution was applied to the side of the third silicone layer, and the first, second and third reinforcing layers were laminated to produce a silicone shell with steps. An artificial implant was produced by injecting a filler into the silicone shell.

[0058] Example 4 The breast-shaped mold was immersed in a silicone solution to form a first silicone layer. The silicone solution was applied to the sides of the first silicone layer to laminate the first reinforcing layer, and the mold was then immersed again in the silicone solution to form a second silicone layer, producing a silicone shell with a step. The artificial implant was produced by injecting a filler into the silicone shell.

[0059] Example 5 The breast-shaped mold was immersed in a silicone solution to form a first silicone layer. The silicone solution was applied to the sides of the formed first silicone layer to laminate the first reinforcing layer, and then the mold was immersed again in the silicone solution to form a second silicone layer. The silicone solution was applied to the sides of the formed second silicone layer to laminate the second reinforcing layer, and then the mold was immersed again in the silicone solution to form a third silicone layer, producing a silicone shell with a step. The artificial implant was produced by injecting a filler into the inside of the produced silicone shell.

[0060] Example 6 The breast-shaped mold was immersed in a silicone solution to form a first silicone layer. The side of the first silicone layer was coated with silicone solution to laminate the first reinforcing layer, and then the mold was immersed again in the silicone solution to form a second silicone layer. The side of the second silicone layer was coated with silicone solution to laminate the second reinforcing layer, and then the mold was immersed again in the silicone solution to form a third silicone layer. The side of the third silicone layer was coated with silicone solution to laminate the third reinforcing layer, and then the mold was immersed again in the silicone solution to form a fourth silicone layer, thereby producing a silicone shell with a step. An artificial implant was produced by injecting a filler into the inside of the produced silicone shell.

[0061] Comparative Example The breast-shaped mold was immersed in the silicone solution three times to sequentially form the first, second and third silicone layers, which were then laminated to a uniform thickness of 0.5 mm to produce a silicone shell. The filler was then injected into the silicone shell to produce an artificial implant.

[0062] Experimental example 1: Side thickness measurement The number of layers of the reinforcing layer of the artificial implants manufactured in the examples and comparative examples and the thickness of the side surface thereof were measured, and the results are shown in Table 1.

[0063] [Table 1]

[0064] Referring to Table 1, it can be seen that the thickness of the side portion increases as the number of times the reinforcing layer is laminated increases. Although the lamination methods of Examples 1 to 3 and Examples 4 to 6 are different, that is, a method of laminating a reinforcing layer after forming a silicone layer and a method of cross-laminating a silicone layer and a reinforcing layer, it can be seen that when the number of times the reinforcing layer is laminated is the same, the thickness of the side portion shows similar values.

[0065] Experimental example 2: Evaluation of the physical properties of artificial implants The artificial implants manufactured according to the experimental and comparative examples were evaluated for burst strength and elongation. The results are shown in Table 2, and the measured values ​​of the burst strength and elongation are shown in graphs in FIGS. 9 and 10, respectively.

[0066] [Table 2]

[0067] Referring to Table 2, it can be seen that the artificial implants of Examples 1 to 6 have burst strength values ​​in the range of 28 to 37 N, and the burst strength value improves as the number of reinforcing layer stacks increases. This shows that durability is improved by increasing the number of reinforcing layer stacks and strengthening the thickness of the side parts, and it is expected that side effects such as bursting, breakage, and rippling can be prevented when inserted into the user's body, thereby increasing the user's satisfaction. In contrast, it can be seen that the artificial implant of the comparative example has a uniform thickness in all areas, and the burst strength value is lower than that of the examples.

[0068] In addition, it was confirmed that the elongation rate of the artificial implants of Examples 1 to 6 decreased as the number of reinforcing layer layers increased, and it was expected that the shape to be realized would be continuously maintained even if the filling material was injected. In contrast, the artificial implant of the comparative example showed the highest elongation rate of 545%, and it was expected that the artificial implant would deform over time, which would cause side effects such as breakage and rupture of the artificial implant.

[0069] The above description of the present specification is merely illustrative, and a person having ordinary skill in the art to which one aspect of the present specification belongs can easily understand that the present specification can be easily modified into other specific forms without changing the technical ideas and essential features described in the present specification. Therefore, the above-described embodiments should be understood to be illustrative in all respects and not limiting. For example, each component described as a single type can be implemented in a distributed form, and similarly, each component described as a distributed type can be implemented in a combined form.

[0070] The scope of this specification is indicated by the claims set forth below, and all modifications and variations derived from the meaning and scope of the claims and their equivalent concepts must be interpreted as being included in the scope of the present invention. [Explanation of symbols]

[0071] 100: Artificial implants 110: Silicon shell top 120: Silicon shell bottom 130: Side of silicon shell 140: Reinforcement structure 11, 12, 13, 14: first silicon layer, second silicon layer, third silicon layer, fourth silicon layer 21, 22, 23: First reinforcing layer, second reinforcing layer, third reinforcing layer

Claims

1. A silicone shell having a top portion, a bottom portion, and a side portion; and a filler injected into the interior of the silicone shell; The silicone shell includes one or more silicone layers and one or more reinforcing layers formed on at least a portion of a surface of the silicone layer; The reinforcing layer is provided on at least a portion of the lower portion and the side portion of the silicone shell, The reinforcing layer is laminated on the surface of the silicone layer to form a stepped layered structure on the outer surface of the silicone shell.

2. 2. The artificial implant of claim 1, wherein at least a portion of the silicone shell is formed by one or more of the silicone layers and one or more of the reinforcing layers being continuous or intersecting.

3. 2. The artificial implant according to claim 1, characterized in that the thickness of the silicone shell is 0.4-1.2 mm and the thickness of the reinforcing layer is 0.01-0.3 mm.

4. 2. The artificial implant of claim 1, wherein the thickness of the upper and lower parts of the silicone shell is 0.4-0.8 mm, and the thickness of the reinforced side part of the silicone shell is 0.4-1.2 mm.

5. 2. The artificial implant according to claim 1, wherein the portion of the silicone shell having the reinforcing layer satisfies at least one of the following conditions (i) to (ii): (i) Bursting strength 25-50N (ii) Elongation rate: 400 to 520%

6. 2. The artificial implant of claim 1, wherein a cross-sectional shape of the artificial implant is one selected from the group consisting of a circle, an oval, and a teardrop.

7. (a) immersing a breast-shaped mold into a silicone solution to form one or more silicone layers; (b) applying a silicone solution to at least a portion of the silicone layer to form one or more reinforcing layers; (c) drying and curing the formed silicone layer and reinforcing layer to produce a silicone shell; (d) forming an injection groove so that a filler can be injected into the internal space of the silicon shell; and (e) injecting the filler through the injection channel; The reinforcing layer is provided on at least a portion of the lower portion and the side portion of the silicone shell, 2. A method for producing an artificial implant, comprising: laminating a reinforcing layer on a surface of the silicone layer to form a stepped layered structure on an outer surface of the silicone shell.

8. The method for producing an artificial implant according to claim 7, wherein each of steps (a) and (b) is repeated 1 to 10 times.

9. The method for producing an artificial implant according to claim 7, wherein the steps (a) and (b) are alternately performed 1 to 10 times, respectively.

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