KR20220121321A - Prosthesis with excellent stability and manufacturing method thereof - Google Patents

Abstract

Disclosed is an artificial implant, and a manufacturing method therefor. The artificial implant according to the present invention comprises: a silicone shell consisting of an upper, lower and side portions; and a filler that is injected inside the silicone shell. The silicone shell includes one or more silicon layers and one or more reinforced layers, wherein the reinforced layer is provided in at least a part of the lower and side portions of the silicone shell.

Description

Artificial prosthesis with excellent stability and manufacturing method thereof

The present invention relates to an artificial implant having excellent stability and a method for manufacturing the same.

An artificial breast implant is a grade 4 medical device in which a gel or saline solution of an appropriate viscosity is filled inside the silicone shell forming the outer shell of the implant, and special biostability is required in vivo. The implant industry has secured the physical properties required as a medical device by adjusting the thickness of the silicone shell or changing the ingredients of the filling, and research and development are in progress so that it can have a natural shape by adjusting the physical properties of the filling. .

However, artificial implants still have a potential risk of side effects after implantation. In particular, a rippling phenomenon due to the occurrence of folding of the silicon shell occurs frequently. The rippling phenomenon is a side effect in which the wrinkles formed on the surface of the implant appear as a wave pattern on the skin surface of the breast. The durability of the position may be deteriorated, which may lead to rupture of the implant.

As such, when the artificial implant is ruptured, the filling material present inside the implant may leak to the outside. As the filler leaks, an inflammatory reaction may occur inside the human body, and furthermore, tissue necrosis, bacterial infection, capsular contracture, and anaplasia associated with breast implants may cause severe pain to the user due to an overactive immune response. It can cause Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). In particular, users who develop spheroid contracture must undergo reoperation, and users who develop BIA-ALCL may be at risk of death.

As described above, in order to solve the problems of the conventional artificial prosthesis, it is most important to prevent the rupture of the prosthesis in advance. In particular, since the rippling phenomenon continuously occurs only in a specific portion of the silicone shell, which is the outer skin of the implant, the durability is lowered.

In order to solve the problems of the prior art described above, it is to prevent rupture by providing an artificial prosthesis having excellent mechanical stability and a method for manufacturing the same.

According to one aspect, a silicon shell consisting of an upper portion, a lower portion and a side portion; and a filler injected into the silicon shell, wherein the silicon shell includes one or more silicon layers and one or more reinforcing layers, wherein the reinforcing layer is provided with an artificial prosthesis provided under the silicon shell.

According to another aspect, a silicon shell consisting of an upper portion, a lower portion and a side portion; and a filler injected into the silicon shell, wherein the silicon shell includes one or more silicon layers and one or more reinforcing layers, wherein the reinforcing layer is provided on a side surface of the silicon shell.

According to another aspect, a silicon shell consisting of an upper portion, a lower portion and a side portion; and a filler injected into the silicon shell, wherein the silicon shell includes at least one silicon layer and at least one reinforcing layer, wherein the reinforcing layer is provided in the lower and side portions of the silicon shell.

In one embodiment, at least a portion of the silicon shell may be formed continuously or intersected with one or more of the silicon and one or more of the reinforcing layers.

In one embodiment, the thickness of the silicon shell may be 0.4 ~ 1.2 mm, the thickness of the reinforcing layer may be 0.01 ~ 0.3 mm.

In one embodiment, the burst strength of the portion of the silicon shell provided with the reinforcing layer may be 25 ~ 50N.

In one embodiment, the elongation of the portion of the silicon shell provided with the reinforcing layer may be 400 to 520%.

In an embodiment, the cross-sectional shape of the artificial prosthesis may be one selected from a circle, an oval, and a teardrop.

According to another aspect, the method comprising: (a) immersing a breast-shaped mold in a silicone solution to form one or more silicone layers; (b) forming one or more reinforcing layers by applying a silicone solution to at least a portion of the silicon layer; (c) drying and curing the formed silicone layer and the reinforcing layer to prepare a silicone shell; (d) forming an injection groove to inject a filler into the inner space of the silicon shell; and (e) injecting the filler through the injection groove, wherein the reinforcing layer is formed on at least a portion of a lower portion and a side portion of the silicon shell.

In one embodiment, steps (a) and (b) may be repeated 1 to 10 times, respectively.

In one embodiment, steps (a) and (b) may be alternately performed 1 to 10 times, respectively.

According to one aspect, it is possible to provide an artificial prosthesis and a manufacturing method thereof, which can prevent a folding phenomenon and resulting rupture and damage by reinforcing mechanical weaknesses, thereby having excellent durability and rupture resistance.

The effect of one aspect of the present specification is not limited to the above-described effect, but it should be understood to include all effects that can be inferred from the configuration described in the detailed description or claims of the present specification.

1 is a cross-sectional view of an artificial prosthesis having a lower portion reinforced according to an embodiment of the present specification.
2 is a cross-sectional view of an artificial prosthesis having a lower portion reinforced according to another embodiment of the present specification.
3 is a cross-sectional view of an artificial prosthesis having a side portion reinforced according to another embodiment of the present specification.
4 is a cross-sectional view of an artificial prosthesis having a side portion reinforced according to another embodiment of the present specification.
5 is a cross-sectional view of an artificial prosthesis with reinforced lower and side portions according to another embodiment of the present specification.
6 is a cross-sectional view of the artificial prosthesis reinforced with the lower part and the side part according to another embodiment of the present specification.
7 is a graph of elongation rates of Examples and Comparative Examples of the present specification.
8 is a burst strength graph of Examples and Comparative Examples of the present specification.

Hereinafter, one aspect of the present specification will be described with reference to the accompanying drawings. However, the description of the present specification may be implemented in several different forms, and thus is not limited to the embodiments described herein. And in order to clearly describe one aspect of the present specification in the drawings, parts irrelevant to the description are omitted, and similar reference numerals are attached to similar parts throughout the specification.

Throughout the specification, when a part is "connected" with another part, this includes not only the case of being "directly connected" but also the case of being "indirectly connected" with another member interposed therebetween. . In addition, when a part "includes" a certain component, this means that other components may be further provided without excluding other components unless otherwise stated.

When a range of numerical values is recited herein, the values have the precision of the significant figures provided in accordance with the standard rules in chemistry for significant figures, unless the specific range is otherwise stated. For example, 10 includes the range of 5.0 to 14.9 and the number 10.0 includes the range of 9.50 to 10.49.

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

artificial prosthesis

The artificial prosthesis 100 according to one side includes a silicon shell including an upper part 110 , a lower part 120 , and a side part 130 ; and a filler injected into the silicon shell, wherein the silicon shell includes one or more silicon layers and one or more reinforcing layers, wherein the reinforcing layer is at least part of the lower portion 120 and the side portion 130 of the silicon shell. can be provided.

In one example, the artificial prosthesis 100, as shown in Figures 1 and 2, a silicone shell consisting of an upper portion 110, a lower portion 120, and a side portion 130; and a filler injected into the silicon shell, wherein the silicon shell includes one or more silicon layers and one or more reinforcing layers, and the reinforcing layer may be provided in the lower portion 120 of the silicon shell.

In another example, the artificial prosthesis 100, as shown in FIGS. 3 and 4, a silicone shell consisting of an upper part 110, a lower part 120, and a side part 130; and a filler injected into the silicon shell, wherein the silicon shell includes one or more silicon layers and one or more reinforcing layers, and the reinforcing layer may be provided on the side portion 130 of the silicon shell.

In another example, the artificial prosthesis 100, as shown in FIGS. 5 and 6, a silicon shell consisting of an upper portion 110, a lower portion 120, and a side portion 130; and a filler injected into the silicon shell, wherein the silicon shell includes at least one silicon layer and at least one reinforcing layer, and the reinforcing layer may be provided on the lower portion 120 and the side portion 130 of the silicon shell. have.

In conventional artificial implants, the silicone shell is generally inserted into the human body in the form of a filler injected therein after all regions have the same thickness, and the shell can easily be folded in a specific region due to the properties of the gel and gravity. . For example, the folding phenomenon of the shell occurs frequently in the side portion of the silicon shell. If the shell folds while the artificial implant is inserted into the body as an artificial breast implant, this may cause a ripple phenomenon in which a wave pattern is revealed on the surface of the breast, thereby reducing the physical properties of the side part of the silicone shell. This may lead to breakage of the silicone shell.

The artificial prosthesis 100 according to one aspect of the present specification may improve durability and rupture resistance to improve these problems.

1 to 6 show examples of various embodiments of the artificial prosthesis 100 according to an aspect of the present specification. 1 to 6 , the artificial prosthesis 100 includes a silicone shell forming an exterior, and the silicone shell may be divided into an upper part 110 , a lower part 120 , and a side part 130 . The silicon shell may include one or more silicon layers and one or more reinforcing layers.

A filler may be injected into the silicon shell to maintain the shape of the artificial implant 100 .

The silicon shell may be basically formed by laminating one or more silicon layers, and among them, at least a portion of the lower portion 120 and the side portion 130 may be formed by laminating one or more silicon layers and one or more reinforcing layers.

For example, FIGS. 1 and 2 are examples of the artificial prosthesis 100 in which the lower part 120 has at least one reinforcing layer, and FIGS. 3 and 4 are artificial prostheses 100 in which the side part 130 has at least one reinforcing layer. It is an example of the prosthesis 100, and FIGS. 5 and 6 are examples of the artificial prosthesis 100 in which both the lower part 120 and the side part 130 have at least one reinforcing layer. As such, at least a portion of the lower portion 120 and the side portion 130 may have a reinforced structure by providing one or more reinforcing layers according to the necessary purpose. Through such a reinforced structure, durability and tear resistance of the artificial prosthesis 100 may be improved, thereby preventing a folding phenomenon.

The end of the reinforcing layer may be formed with a step-like step of 1 to 10 layers. For example, the first, second, third, fourth, fifth, sixth, seventh, eighth, ninth, or tenth floor may be a stepped step, but is not limited thereto.

1, 3 and 5 show a gradual layered structure (A) formed in a stepped structure of two or more layers. By forming a gradual layered structure with a gentle end without such a sharp difference in thickness, stress concentration can be prevented and usability can be improved.

2, 4 and 6 show a layered structure (B) formed in a stepped structure of one layer. By forming a layered structure having such a step, the strength of the area to be reinforced can be improved evenly.

As such, at least a portion of the silicon shell may have a reinforcing structure formed by successive or intersecting one or more silicon layers and one or more reinforcing layers. Such a reinforcing structure can be freely selected according to the desired properties of the final product.

The silicon shell may have a thickness of 0.4 to 1.2 mm, and the thickness of the reinforcing layer may be 0.01 to 0.3 mm. The thickness of the portion not provided with the reinforcing structure may be 0.4 to 0.8 mm, for example, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, or 0.8 mm, but is not limited thereto. The region provided with the reinforcing structure 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 or 1.2 mm, but is limited thereto. it's not going to be If the reinforcing structure of the silicone shell is less than 0.4 mm, mechanical properties may be lowered, and damage and aesthetic side effects may occur. may cause The thickness may include the thickness of the silicon layer or the thickness of the silicon 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, 0.12mm, 0.13mm, 0.14mm, 0.15mm, 0.16mm, 0.17mm, 0.18mm, 0.19mm, 0.2mm, 0.21mm, 0.22mm, 0.23mm, 0.24mm, 0.25mm, 0.26mm, 0.27mm, 0.28mm , may be 0.29 mm or 0.3 mm, but is not limited thereto. If the thickness of the reinforcing layer is less than 0.01 mm, the lateral stability of the side portion 130 may be reduced, and if it exceeds 0.3 mm, the thickness deviation between each region of the silicon shell may excessively occur, thereby reducing durability due to stress concentration. The thickness of the reinforcing layer may be changed according to the desired thickness of the reinforcing structure and the number of reinforcing layers. When a plurality of relatively thin reinforcing layers are stacked, a user's sense of foreign body may be minimized, and if a small number of thick reinforcing layers are used, manufacturing convenience may be excellent.

On the other hand, the burst strength of the portion of the silicon shell provided with the reinforcing layer may be 25 ~ 50N. For example, 25N, 26N, 27N, 28N, 29N, 30N, 31N, 32N, 33N, 34N, 35N, 36N, 37N, 38N, 39N, 40N, 41N, 42N, 43N, 44N, 45N, 46N, 47N, It may be 48N, 49N or 50N, but is not limited thereto. The silicone shell constituting the outer shell of the artificial prosthesis 100 may have the durability and rupture resistance of the shell reinforced by the reinforcing layer, and thus the rupture strength may have a value satisfying a range of 25 to 50N.

In addition, the elongation of the portion of the silicon shell provided with the reinforcing layer may be 400 to 520%. For example, 400%, 410%, 420%, 430%, 440%, 450%, 460%, 470%, 480%, 490%, 500%, 510%, or 520%, but is not limited thereto. . If the elongation is less than 400%, the texture and feel of the silicone shell may be reduced, and thus user preference may be reduced. If the elongation is more than 520%, the artificial implant 100 may be easily damaged or ruptured.

The artificial prosthesis may have a different shape depending on the insertion site or the purpose of the procedure, for example, may be inserted into various body parts such as breast, nose, buttocks, forehead, but the shape is not particularly limited.

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

The cross-sectional shape of the artificial prosthesis may be one selected from a circle, an oval, and a teardrop, but is not limited thereto. In general, since the shape and shape of a user's breast are formed differently for each user, the type of the artificial prosthesis can be selected in consideration of the user's natural shape and the preference of the user's desired shape, shape, size, and the like.

Manufacturing method of artificial prosthesis

A method of manufacturing an artificial prosthesis according to another aspect includes the steps of: (a) immersing a breast-shaped mold in a silicone solution to form one or more silicone layers; (b) forming one or more reinforcing layers by applying a silicone solution to at least a portion of the silicon layer; (c) drying and curing the formed silicone layer and the reinforcing layer to prepare a silicone shell; (d) forming an injection groove to inject a filler into the inner space of the silicon shell; and (e) injecting the filler through the injection groove, wherein the reinforcing layer may be formed on at least a portion of a lower portion and a side portion of the silicon shell.

A silicone shell forming the outer skin of the artificial implant may be manufactured by the steps (a) to (c). As described above, the silicon shell may include an upper portion 110 , a lower portion 120 and a side portion 130 , and the silicon shell includes one or more silicon layers and one or more reinforcing layers, and includes a layered structure in which a step is formed. By doing so, it may include a reinforcing structure having a reinforced thickness, and thus the stability of the artificial prosthesis may be improved.

Steps (a) and (b) may each independently be repeated 1 to 10 times. For example, step (a) may be repeated 1 time, 2 times, 3 times, 4 times, 5 times, 6 times, 7 times, 8 times, 9 times or 10 times, and the step (a) The silicon layer may be laminated in 1 layer, 2 layers, 3 layers, 4 layers, 5 layers, 6 layers, 7 layers, 8 layers, 9 layers, or 10 layers depending on the number of repetitions. In addition, the step (b) may be repeated 1 time, 2 times, 3 times, 4 times, 5 times, 6 times, 7 times, 8 times, 9 times or 10 times, and repeating the step (b) Depending on the number of times, the reinforcing 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, but is not limited thereto.

On the other hand, the steps (a) and (b) may be independently crossed 1 to 10 times, respectively. For example, the artificial prosthesis manufactured by performing the steps (a) twice and (b) once crossed may be manufactured in the shape of FIG. 8 . Specifically, the silicon shell may sequentially form the first silicon layer 11 , the first reinforcing layer 21 , and the second silicon layer 12 , and the steps (a) and (b) are performed three times. And when step (b) is crossed twice, the silicon shell is sequentially formed with the first silicon layer 11, the first reinforcing layer 21, the second silicon layer 12, the second reinforcing layer 22 and the second 3 A silicon layer 13 may be formed. In this way, a silicon shell having multiple layers can be manufactured.

As such, by adjusting the number of repetitions of steps (a) to (c), the thickness of the layered structure can be controlled, and the immersion and application area is adjusted to provide a reinforcement structure to the lower part 120, the side part 130, or both. can be formed

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 filling material into the silicon shell, and to prevent the injected filling material from leaking to the outside by closing it after injection.

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

Hereinafter, embodiments of the present specification will be described in more detail. However, the following experimental results describe only representative experimental results among the above examples, and the scope and contents of the present specification are reduced or limited by the examples and cannot be interpreted. Each effect of the various embodiments of the present specification not explicitly presented below will be specifically described in the corresponding section.

Example 1

The breast-shaped mold was repeatedly immersed in a silicone solution three times to sequentially form a first silicone layer, a second silicone layer, and a third silicone layer, and laminated to a uniform thickness of 0.5 mm. A silicon shell having a step difference was prepared by applying a silicone solution to the side surface of the third silicon layer and stacking the first reinforcing layer. An artificial implant was prepared by injecting a filler into the manufactured silicone shell.

Example 2

The breast-shaped mold was repeatedly immersed in a silicone solution three times to sequentially form a first silicone layer, a second silicone layer, and a third silicone layer, and laminated to a uniform thickness of 0.5 mm. By applying a silicone solution to the side surface of the third silicon layer, the first reinforcing layer and the second reinforcing layer were laminated to prepare a silicon shell having a step difference. An artificial implant was prepared by injecting a filler into the manufactured silicone shell.

Example 3

The breast-shaped mold was repeatedly immersed in a silicone solution three times to sequentially form a first silicone layer, a second silicone layer, and a third silicone layer, and laminated to a uniform thickness of 0.5 mm. By applying a silicone solution to the side surface of the third silicon layer, the first reinforcing layer, the second reinforcing layer, and the third reinforcing layer were laminated to prepare a silicon shell having a step difference. An artificial implant was prepared by injecting a filler into the manufactured silicone shell.

Example 4

The breast-shaped mold was immersed in a silicone solution to form a first silicone layer. After laminating the first reinforcing layer by applying a silicone solution to the side portion of the formed first silicon layer, the second silicon layer was formed by re-immersion in the silicone solution to prepare a step-formed silicon shell. An artificial implant was prepared by injecting a filler into the manufactured silicone shell.

Example 5

The breast-shaped mold was immersed in a silicone solution to form a first silicone layer. The first reinforcing layer was laminated by applying a silicone solution to the side surface of the formed first silicon layer, and then re-immersed in the silicone solution to form a second silicon layer. After laminating a second reinforcing layer by applying a silicone solution to the side surface of the formed second silicon layer, the second reinforcing layer was re-immersed in the silicone solution to form a third silicon layer, thereby manufacturing a silicon shell having a step. An artificial implant was prepared by injecting a filler into the manufactured silicone shell.

Example 6

The breast-shaped mold was immersed in a silicone solution to form a first silicone layer. The first reinforcing layer was laminated by applying a silicone solution to the side surface of the formed first silicon layer, and then re-immersed in the silicone solution to form a second silicon layer. A silicone solution was applied to the side surface of the formed second silicon layer to laminate a second reinforcing layer, and then re-immersed in the silicone solution to form a third silicon layer. After laminating a third reinforcing layer by applying a silicone solution to the side surface of the formed third silicon layer, the fourth silicon layer was formed by re-immersion in the silicone solution to prepare a silicon shell having a step. An artificial implant was prepared by injecting a filler into the manufactured silicone shell.

comparative example

The breast-shaped mold was repeatedly immersed in a silicone solution three times to sequentially form a first silicone layer, a second silicone layer, and a third silicone layer, and laminated to a uniform thickness of 0.5 mm to prepare a silicone shell. An artificial implant was prepared by injecting a filler into the manufactured silicone shell.

Experimental Example 1: Measurement of side thickness

Table 1 shows the results of measuring the number of times of lamination of the reinforcing layer and the thickness of the side part of the artificial implants manufactured according to Examples and Comparative Examples.

division Number of Reinforcement Layer Laminations Side thickness (mm) comparative example 0 0.5 Example 1 One 0.53 Example 2 2 0.56 Example 3 3 0.59 Example 4 One 0.54 Example 5 2 0.57 Example 6 3 0.60

Referring to Table 1, it can be seen that the thickness of the side part becomes thicker as the number of times of lamination of the reinforcing layer increases. And it can be confirmed that the thickness of the side portion exhibits a similar value when the silicon layer and the reinforcing layer are cross-laminated in a different manner or when the number of laminations of the reinforcing layer is the same.

Experimental Example 2: Evaluation of physical properties of artificial implants

The burst strength and elongation of the artificial implants prepared according to Examples and Comparative Examples were evaluated, and the results are shown in Table 2, and graphs of measured values of the burst strength and elongation, respectively, are shown in FIGS. 7 and 8, respectively.

division Bursting strength (N) Elongation (%) comparative example 24 545 Example 1 28 520 Example 2 32 497 Example 3 36 470 Example 4 30 517 Example 5 32 495 Example 6 37 467

Referring to Table 2, it can be seen that the artificial prostheses of Examples 1 to 6 had a burst strength value in a range of 28 to 37 N, and the burst strength value was improved as the number of laminations of the reinforcing layer increased. It can be confirmed that durability is improved as the thickness of the side part is strengthened as the number of stacking times of the reinforcing layer is increased, and when inserted into the user's body, side effects such as rupture, breakage, and rippling can be prevented, and the user's satisfaction can be increased. it can be expected that On the other hand, it can be seen that the artificial prosthesis of the comparative example was manufactured to have a uniform thickness in all regions, and thus the burst strength value was lowered compared to that of the example.

In addition, it can be confirmed that the elongation rate of the artificial implants of Examples 1 to 6 decreases as the number of laminations of the reinforcing layer increases. On the other hand, the artificial prosthesis of Comparative Example exhibited the highest elongation rate of 545%, so that deformation of the artificial prosthesis may occur over time. .

The description of the present specification described above is for illustration, and those of ordinary skill in the art to which one aspect of the present specification belongs can easily transform it into other specific forms without changing the technical idea or essential features described in this specification. you will be able to understand Therefore, it should be understood that the embodiments described above are illustrative in all respects and not restrictive. For example, each component described as a single type may be implemented in a dispersed form, and likewise components described as distributed may be implemented in a combined form.

The scope of the present specification is indicated by the following claims, and all changes or modifications derived from the meaning and scope of the claims and their equivalents should be construed as being included in the scope of the present specification.

100: artificial prosthesis
110: the upper part of the silicon shell
120: the lower part of the silicon shell
130: side portion of the silicon shell

Claims (11)

a silicone shell consisting of an upper part, a lower part and a side part; and
Including; filling material injected into the silicon shell;
The silicon shell comprises at least one silicon layer and at least one reinforcing layer,
The reinforcing layer is an artificial prosthesis provided under the silicon shell. a silicone shell consisting of an upper part, a lower part and a side part; and
Including; filling material injected into the silicon shell;
The silicon shell comprises at least one silicon layer and at least one reinforcing layer,
The reinforcing layer is an artificial prosthesis provided on the side of the silicon shell. a silicone shell consisting of an upper part, a lower part and a side part; and
Including; filling material injected into the silicon shell;
The silicon shell comprises at least one silicon layer and at least one reinforcing layer,
The reinforcing layer is an artificial prosthesis provided on the lower and side portions of the silicon shell. 4. The method according to any one of claims 1 to 3,
At least a portion of the silicon shell is an artificial prosthesis in which one or more of the silicon layer and the one or more reinforcing layers are continuously or intersected. 4. The method according to any one of claims 1 to 3,
The thickness of the silicon shell is 0.4-1.2 mm,
The thickness of the reinforcing layer is 0.01 to 0.3 mm of the artificial implant. 4. The method according to any one of claims 1 to 3,
An artificial prosthesis having a burst strength of 25-50N in the portion of the silicon shell provided with a reinforcing layer. 4. The method according to any one of claims 1 to 3,
An artificial prosthesis having an elongation of 400 to 520% of a portion of the silicone shell provided with a reinforcing layer. 4. The method according to any one of claims 1 to 3,
The cross-sectional shape of the artificial prosthesis is one selected from a circle, an oval, and a teardrop. (a) immersing the breast-shaped mold in a silicone solution to form one or more silicone layers;
(b) forming one or more reinforcing layers by applying a silicone solution to at least a portion of the silicon layer;
(c) drying and curing the formed silicone layer and the reinforcing layer to prepare a silicone shell;
(d) forming an injection groove to inject a filler into the inner space of the silicon shell; and
(e) injecting the filling material through the injection groove; including,
The reinforcing layer is a method of manufacturing an artificial prosthesis formed on at least a portion of the lower portion and the side portion of the silicon shell. 10. The method of claim 9,
Steps (a) and (b) are each repeated 1 to 10 times, the method of manufacturing an artificial prosthesis. 10. The method of claim 9,
Steps (a) and (b) are each cross-performed 1 to 10 times, the manufacturing method of the artificial prosthesis.

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