Breast implant and manufacturing method thereof

Abstract

The breast implant of the present disclosure comprises: a first housing that accommodates a first filler in an internal space; a second case surrounding the first case and accommodating a second filler in an inner space; a third case surrounding the second case and accommodating a third filler in an inner space; and an injection port that provides spaces for the first case, the second case, and the third case, respectively, into which the first filler, the second filler, and the third filler are injected.

Description

TECHNICAL FIELD

[0001] The present application relates to a breast implant and a manufacturing method thereof, and more particularly, to a breast implant including a plurality of shells and a manufacturing method thereof. BACKGROUND

[0002] Breast augmentation is one of the most frequently performed cosmetic surgeries in the world. In addition, about 2 million or more breast cancer patients occur globally every year, and the number of breast cancer patients who receive breast reconstruction is also increasing. Accordingly, the market for breast implants used for the purpose of breast cosmetics and breast reconstruction is showing a gradual expansion trend.

[0003] In a surgery of implanting a breast implant into the inside of a human body, about 5 cm or more of a patient's skin needs to be incised due to the volume of the breast implant, and such an incision reduces the patient's satisfaction with cosmetics. In addition, the breast implant is generally provided in a circular shape, which is different from the shape of an actual breast, and has a uniform internal density, causing an artificial sense of touch, thereby reducing the patient's satisfaction. Also, most patients who receive breast augmentation and breast reconstruction actually bear psychological stress about rupture of the implant in the body. SUMMARY

[0004] PROBLEMS TO BE SOLVED BY THE INVENTION The present application is intended to solve the above problems.

[0005] Specifically, one of the problems to be solved by the present application is to provide a breast implant capable of reducing the size of an incision scar of a patient who receives breast augmentation and breast reconstruction.

[0006] In addition, one of the problems to be solved by the present application is to provide a breast implant having a shape and a sense of touch similar to those of a breast composed of mammary tissue and adipose tissue.

[0007] In addition, one of the problems to be solved by the present application is to provide a breast implant capable of reducing psychological stress of a patient who receives breast augmentation and breast reconstruction about rupture of a breast implant.

[0008] In addition, one of the problems to be solved by the present application is to provide a manufacturing method of a breast implant having a shape and a sense of touch similar to those of a breast composed of mammary tissue and adipose tissue.

[0009] In addition, one of the problems to be solved by the present application is to provide a manufacturing method of a breast implant capable of reducing the size of an incision scar of a patient who receives breast augmentation and breast reconstruction.

[0010] Further, one of the problems to be solved by the present application is to provide a manufacturing method of a breast implant capable of reducing psychological stress of a patient who has undergone breast augmentation surgery and breast reconstruction surgery on rupture of the breast implant.

[0011] Means for solving the problem To achieve the above object, the present disclosure provides a breast implant including: a first shell accommodating a first filler in an inner space; a second shell surrounding the first shell and accommodating a second filler in the inner space; a third shell surrounding the second shell and accommodating a third filler in the inner space; and an injection port providing a space for injecting the first filler, the second filler, and the third filler to the first shell, the second shell, and the third shell, respectively.

[0012] In an exemplary embodiment, the first filler has a greater density than the second filler, and the second filler has a greater density than the third filler.

[0013] In an exemplary embodiment, the first filler has a greater viscosity than the second filler, and the second filler has a greater viscosity than the third filler.

[0014] In an exemplary embodiment, the first filler has a greater cohesion than the second filler, and the second filler has a greater cohesion than the third filler.

[0015] In an exemplary embodiment, the first filler is a first silicone gel, the second filler is a second silicone gel having a smaller density than the first silicone gel, and the third filler is a third silicone gel having a smaller density than the second silicone gel.

[0016] In an exemplary embodiment, the first filler is a first silicone gel, the second filler is a second silicone gel having a smaller density than the first silicone gel, and the third filler is a physiological saline having a smaller density than the second silicone gel.

[0017] In an exemplary embodiment, the injection port is provided at a combined portion of the first shell, the second shell, and the third shell.

[0018] In an exemplary embodiment, the injection port includes a first injection port providing a space for injecting the first filler to the first shell, a second injection port surrounding the first injection port and providing a space for injecting the second filler to the second shell, and a third injection port surrounding the second injection port and providing a space for injecting the third filler to the third shell.

[0019] In an exemplary embodiment, the injection port corresponds to an areola portion of a human body.

[0020] In an exemplary embodiment, the breast implant further includes a sealing member for sealing the injection port.

[0021] In an exemplary embodiment, the first shell includes a first filling portion accommodating the first filler, and a first hanging portion connected with the first filling portion and hanging the first filling portion inside the second shell, and the second shell includes a second filling portion accommodating the second filler, and a second hanging portion connected with the second filling portion and hanging the second filling portion inside the third shell.

[0022] The present disclosure provides a breast implant including a first shell accommodating a first filler in an inner space, a second shell surrounding the first shell and accommodating a second filler in the inner space, and an injection port providing a space for injecting the first filler and the second filler for the first shell and the second shell, respectively, wherein a density of the first filler is greater than a density of the second filler.

[0023] In an exemplary embodiment, the first filler is a silicone having a first density, and the second filler is a silicone having a second density less than the first density.

[0024] In an exemplary embodiment, the first filler is a silicone having a first density, and the second filler is a physiological saline having a second density less than the first density.

[0025] In an exemplary embodiment, a viscosity of the first filler is greater than a viscosity of the second filler.

[0026] In an exemplary embodiment, a cohesion of the first filler is greater than a cohesion of the second filler.

[0027] In an exemplary embodiment, the injection port corresponds to an areola portion of a human body, and the injection port includes a first injection port providing a space for injecting the first filler for the first shell, and a second injection port surrounding the first injection port and providing a space for injecting the second filler for the second shell.

[0028] In an exemplary embodiment, the first shell includes a first filling portion accommodating the first filler, and a first hanging portion connected to the first filling portion and hanging the first filling portion inside the second shell, and a cross-sectional area of the first hanging portion in a horizontal direction is smaller than a cross-sectional area of the first filling portion in the horizontal direction when the breast implant is arranged with the injection port upward.

[0029] To achieve the above object, according to an exemplary embodiment of the present disclosure, there is provided a manufacturing method of a breast implant, including the steps of: coating a surface of a breast implant mold structure including a first mold portion having a first volume, a second mold portion having a second volume smaller than the first volume, and a connecting mold portion for connecting the first mold portion and the second mold portion; solidifying the coating liquid on the surface of the breast implant mold structure to form a first breast implant shell including a first shell corresponding to the first mold portion, a second shell corresponding to the second mold portion, and a hanging shell corresponding to the connecting mold portion; separating the breast implant mold structure from the first breast implant shell; and inserting the second shell and the hanging shell into an inner space of the first shell to form a second breast implant shell having a structure in which the second shell is hung by the hanging shell in the inner space of the first shell.

[0030] In an exemplary embodiment, the manufacturing method of the breast implant further includes the steps of: closing openings of the first shell and the hanging shell by bonding a patch; and injecting a first filler into the first shell and a second filler into the second shell and the hanging shell.

[0031] In an exemplary embodiment, a first density of the first filler is smaller than a second density of the second filler.

[0032] In an exemplary embodiment, a first viscosity of the first filler is smaller than a second viscosity of the second filler.

[0033] In an exemplary embodiment, a first cohesive force of the first filler is smaller than a second cohesive force of the second filler.

[0034] In an exemplary embodiment, a first elastic modulus of the first filler is smaller than a second elastic modulus of the second filler.

[0035] In an exemplary embodiment, the first filler is a first silicone gel, and the second filler is a second silicone gel having a density greater than the first silicone gel.

[0036] In an exemplary embodiment, the second filler is silicone, and the first filler is physiological saline having a lower density than the silicone.

[0037] In an exemplary embodiment, the method of manufacturing a breast implant further includes the steps of adjusting the thickness of the coating liquid on the breast implant mold structure by rotating the breast implant mold structure, and checking whether the first breast implant shell leaks by injecting a test liquid into the first breast implant shell.

[0038] In an exemplary embodiment, the connecting mold portion of the breast implant mold structure has a shape in which the horizontal width thereof gradually decreases as it moves away from the first mold portion and approaches the second mold portion.

[0039] In an exemplary embodiment, the connecting mold portion of the breast implant mold structure has a shape in which the horizontal width thereof gradually increases as it moves away from the first mold portion and approaches the second mold portion.

[0040] In an exemplary embodiment, the second mold portion is formed to have a shape of breast tissue including a plurality of shell pockets.

[0041] In an exemplary embodiment, the length of the connecting mold portion in the vertical direction is 0.2 cm to 4.0 cm.

[0042] In an exemplary embodiment, the volume of the second shell is 25% to 85% of the volume of the first shell.

[0043] Inventive Effects The breast implant of the present disclosure includes a plurality of shells, and can be implanted into a human body in a state in which only a portion of the plurality of shells is filled with a filler, thereby reducing the size of a patient's incision scar and improving cosmetic satisfaction.

[0044] In addition, the breast implant of the present disclosure includes a plurality of shells, and the outermost shell among the plurality of shells can include physiological saline as a filler, thereby reducing the size of a patient's incision scar and improving cosmetic satisfaction when the breast implant is implanted into a human body.

[0045] In addition, the breast implant of the present disclosure includes a plurality of shells, and a filler for filling the plurality of shells can have a higher density, viscosity, and cohesion as it is closer to the inside of the breast implant, and thus the breast implant of the present disclosure can achieve a shape and a tactile sensation similar to those of a human breast.

[0046] In addition, since the physiological saline is filled in the shell forming the appearance of the breast implant of the present disclosure, even if the shell is damaged by external impact to cause the filling to leak, the filling can be absorbed by the human body, thereby reducing the proportion of capsular contracture and alleviating the psychological stress of the patient on the rupture of the breast implant.

[0047] The manufacturing method of the breast implant according to the exemplary embodiments of the present disclosure can include the steps of forming a first breast implant shell including a first shell, a second shell, and a hanging shell for connecting the first shell and the second shell; inserting the second shell and the hanging shell into an inner space of the first shell, thereby forming a second breast implant shell having a structure in which the second shell is hung by the hanging shell in the inner space of the first shell; and filling a first filling into the first shell, and filling a second filling into the second shell and the hanging shell. The breast implant manufactured by the manufacturing method of the present disclosure can achieve a shape and a tactile sensation similar to those of a breast composed of mammary tissue and adipose tissue.

[0048] In addition, the breast implant obtained by the manufacturing method of the breast implant according to the exemplary embodiments of the present disclosure is more easily compressed than the conventional implant in breast augmentation and breast reconstruction, and the outer shell portion can be filled after being implanted in the body, so that the size of the incision scar of the patient can be reduced.

[0049] Further, when the breast implant manufactured by the manufacturing method of the breast implant according to the exemplary embodiments of the present disclosure contains physiological saline in the outer shell portion, the patient can immediately perceive the rupture once the breast implant is ruptured, and the physiological saline is more safely absorbed by the human body. Thus, the patient can more safely plan a breast implant replacement or removal surgery. That is, the psychological stress of the patient who has undergone breast augmentation and breast reconstruction on the rupture of the breast implant can be reduced. BRIEF DESCRIPTION OF DRAWINGS

[0050] Figure 1 FIG. 1 is a view showing the structure of a breast implant according to an exemplary embodiment of the present disclosure.

[0051] Figure 2 FIG. 2 is a view showing the structure of a breast implant according to another exemplary embodiment of the present disclosure. Figure 1 FIG. 3 is a view showing the structure of a breast implant according to another exemplary embodiment of the present disclosure.

[0052] Figure 3 FIG. 4 is a view showing a breast implant of the present disclosure arranged in a breast of a patient who has undergone breast reconstruction.

[0053] Figure 4 FIG. 5 is a view showing a breast implant of the present disclosure arranged in a breast of a person who has undergone breast augmentation.

[0054] Figure 5A diagram showing the position of the body incised for performing a breast augmentation and a breast reconstruction.

[0055] Figure 6 A diagram showing a breast implant in which a part of the shell is filled with a filler.

[0056] Figure 7 A diagram of a breast in which a breast implant according to a comparative example is implanted.

[0057] Figure 8 A diagram of a breast in which a breast implant of the present disclosure is implanted.

[0058] Figure 9 A diagram showing a breast in which a breast implant according to a comparative example is implanted.

[0059] Figure 10 A diagram showing a breast in which a breast implant of the present disclosure is implanted.

[0060] Figure 11 A flowchart showing the flow of a manufacturing method of a breast implant according to an exemplary embodiment of the present disclosure.

[0061] Figure 12 A flowchart showing the flow of a manufacturing method of a breast implant according to an exemplary embodiment of the present disclosure.

[0062] Figure 13 A diagram showing a breast implant according to an exemplary embodiment of the present disclosure.

[0063] Figure 14 A diagram showing the structure of a breast implant according to an exemplary embodiment of the present disclosure.

[0064] Figure 15 A diagram showing the flow of a plurality of shells in a breast implant according to an exemplary embodiment of the present disclosure.

[0065] Figure 16 A flowchart showing the flow of a manufacturing method of a breast implant according to an exemplary embodiment of the present disclosure.

[0066] Figure 17 A diagram showing a step of coating the surface of a breast implant mold structure according to an exemplary embodiment of the present disclosure.

[0067] Figure 18 and Figure 19 A diagram showing a step of coating the surface of a breast implant mold structure according to an exemplary embodiment of the present disclosure. Figure 17 A diagram showing a breast implant mold structure in which the connecting mold portions are enlarged and indicated by "A".

[0068] Figure 20FIG. 10 is a diagram to show a step of curing a coating liquid applied to a surface of a breast implant mold structure according to an exemplary embodiment of the present disclosure to form a first breast implant shell.

[0069] Figure 21 FIG. 11 is a diagram to show a step of separating a breast implant mold structure from the first breast implant shell S1 according to an exemplary embodiment of the present disclosure.

[0070] Figure 22 FIG. 12 is a diagram to show a step of inserting a second shell and a pendant shell into an inner space of the first shell to form a second breast implant shell according to an exemplary embodiment of the present disclosure.

[0071] Figure 23 FIG. 13 is a flowchart to show a flow of a manufacturing method of a breast implant according to an exemplary embodiment of the present disclosure.

[0072] Figure 24 FIG. 14 is a diagram to show a step of joining to close a first opening of the first shell and a second opening of the pendant shell by a patch according to the present disclosure.

[0073] Figure 25 FIG. 15 is a diagram to show a step of injecting a first filler into the first shell, and a second filler into the second shell and the pendant shell according to the present disclosure.

[0074] Figure 26 FIG. 16 is a flowchart to show a flow of a manufacturing method of a breast implant according to an exemplary embodiment of the present disclosure.

[0075] Figure 27 FIG. 17 is a diagram to show a step of applying a coating to a surface of a breast implant mold structure according to an exemplary embodiment of the present disclosure.

[0076] Figure 28 FIG. 18 is a diagram to show a method of manufacturing a breast implant using a breast implant mold structure according to an exemplary embodiment of the present disclosure.

[0077] Figure 29 FIG. 19 is a diagram of a breast implant according to a comparative example and a breast implant of the present disclosure.

[0078] Figure 30 FIG. 20 is a diagram of shapes when the breast implant according to the comparative example and the breast implant of the present disclosure are arranged on a flat surface.

[0079] Figure 31 FIG. 21 is a diagram of shapes when the breast implant according to the comparative example and the breast implant of the present disclosure are arranged on a vertical surface. DETAILED DESCRIPTION

[0080] BEST MODE FOR CARRYING OUT THE INVENTION The breast implant of the present disclosure includes a first shell accommodating a first filler in an inner space, a second shell surrounding the first shell and accommodating a second filler in the inner space, a third shell surrounding the second shell and accommodating a third filler in the inner space, and an injection port providing a space for injecting the first, second, and third fillers to the first, second, and third shells, respectively.

[0081] Means for carrying out the invention Hereinafter, preferred embodiments of the present disclosure will be described in detail with reference to the accompanying drawings. The advantages and features of the present disclosure and methods of achieving them can be apparent from the embodiments described below and the accompanying drawings. However, the technical idea of the present disclosure is not limited to the embodiments described below, and can be implemented by various modes different from each other, and the following embodiments are only for enabling the present disclosure to be sufficiently disclosed, for a person having an ordinary knowledge in the technical field to which the present disclosure pertains to be able to fully understand the scope of the present disclosure, and the technical idea of the present disclosure is determined by the scope of the claims.

[0082] When adding reference numerals to components in all the drawings, it should be noted that even components shown in different drawings have the same reference numerals, and the same components are referred to. Also, in explaining the present disclosure, when it is considered that detailed description of related known technology construction or function will confuse the gist of the present disclosure, detailed description thereof can be omitted. In addition, Figure X The reference numerals in Figure X the components indicated in the drawings, even if the same as the reference numerals in other drawings, should not be interpreted as referring to the components of the other drawings.

[0083] If not specially defined, all terms (including technical and scientific terms) used in the present specification can be used as meanings commonly understood by a person having an ordinary knowledge in the technical field to which the present disclosure pertains. Also, terms commonly used in a dictionary are not to be interpreted abnormally or excessively, unless they are clearly specially defined. The terms used in the following embodiments are only for the purpose of explaining the embodiments and are not intended to limit the present disclosure. In the following embodiments, unless otherwise specified, a singular form of a noun also includes a plural form.

[0084] Also, in describing the components of the disclosure, terms such as first, second, A, B, (a), (b), etc. can be used. These terms are used only to distinguish the components from other components, and the nature, order or sequence of the related components is not limited by the terms. It should be understood that if one component is described as being "connected", "coupled", or "linked" to another component, it can mean that the component is not only directly "connected", "coupled", or "linked" to the other component, but can also be "connected", "coupled", or "linked" indirectly via a third component.

[0085] The terms "include" and / or "comprise" used in the disclosure designate the presence of the stated components, steps, operations and / or elements, but do not exclude the presence or addition of one or more other components, steps, operations and / or elements.

[0086] Components having the same function as the components included in any embodiment can be described using the same name in other embodiments. Unless stated to the contrary, the description set forth in any embodiment can also be applicable to other embodiments, and specific description can be omitted within the scope of repetition or within the scope of clear understanding of those skilled in the art.

[0087] Hereinafter, the present disclosure will be described in detail with reference to the preferred embodiments of the present disclosure and the accompanying drawings.

[0088] Figure 1 A diagram of a structure of a breast implant 10 according to an exemplary embodiment of the present disclosure.

[0089] Referring to Figure 1 The breast implant 10 according to the present disclosure can include a first shell 110, a second shell 120, a third shell 130, a first filler Fm1, a second filler Fm2, a third filler Fm3, and a filling inlet 140, etc.

[0090] The first shell 110 can be a shell that accommodates the first filler Fm1. Specifically, the first shell 110 can be a shell that provides an internal space for accommodating the first filler Fm1, and can be an innermost shell among the plurality of shells 110, 120, 130 included in the breast implant 10 of the present disclosure.

[0091] In the exemplary embodiment, the material of the first shell 110 can include silicone. However, the material of the first shell 10 is not limited to silicone, and can also include other materials. For example, the material of the first shell 110 can include a flexible material such as rubber, etc. In addition, the material of the first shell 110 can include an organic compound or a polymer material having biocompatibility with the human body.

[0092] The first case 110 can be disposed inside the second case 120 which will be described below. In an exemplary embodiment, the first case 110 can be provided in an inner space of the second case 120 in a state in which at least a portion of the first case 110 is combined with the second case 120. For example, at least a portion of the first case 110 can be directly combined with the second case 120, or at least a portion of the first case 110 can be combined with the second case 120 through a separate combining member.

[0093] In other words, at least a portion of the first case 110 is combined with the second case 120 such that the first case is disposed in a suspended state in the inner space of the second case 120. Thereby, a portion of the first case 110 can move freely within the inner space of the second case 120 based on an external force or gravity generated by a body movement including the breast implant 10 of the present disclosure. For example, the movement of the plurality of cases included in the breast implant 10 of the present disclosure can be more smooth compared to a breast implant composed of a single case.

[0094] The first filler Fm1 can be a material filling the inner space of the first case 110. In an exemplary embodiment, the material of the first filler Fm1 can include silicone. In particular, the first filler Fm1 can be silicone provided in a gel form. In addition, the material of the first filler Fm1 can also be physiological saline. However, the material of the first filler Fm1 is not limited to the above.

[0095] The first filler Fm1 can have a first density. The density of the first filler Fm1 can be defined as a mass corresponding to a unit volume of the first filler Fm1. For example, when the first filler Fm1 includes first silicone, the density of the first silicone can be defined as the first density.

[0096] In an exemplary embodiment, the first density of the first filler Fm1 can be greater than a second density of a second filler Fm2 for filling the second case 120 which will be described below, and can be greater than a third density of a third filler Fm3 for filling the third case 130 which will be described below. That is, the first density of the first filler Fm1 can be the maximum value among the densities of the plurality of fillers Fm1, Fm2, Fm3.

[0097] In addition, the first filler Fm1 can have a first viscosity. The viscosity of the first filler Fm1 can be defined as a thick and sticky property of the first filler Fm1, and the viscosity of the first filler Fm1 can be defined as a degree of viscosity of the first filler Fm1. For example, a greater viscosity indicates a higher resistance to the flow of a fluid, and a smaller viscosity indicates a lower resistance to the flow of a fluid.

[0098] In an exemplary embodiment, the first viscosity of the first filler Fm1 can be greater than a second viscosity of a second filler Fm2 for filling the second shell 120, which will be described below, and can be greater than a third viscosity of a third filler Fm3 for filling the third shell 130, which will be described below. That is, the first viscosity of the first filler Fm1 can be the maximum among the viscosities of the plurality of fillers Fm1, Fm2, Fm3.

[0099] For example, a coefficient of viscosity of the first filler Fm1 can be defined as a numerical value of the viscosity of a liquid. For example, the first coefficient of viscosity of the first filler Fm1 can be greater than a second coefficient of viscosity of a second filler Fm2 for filling the second shell 120, which will be described below, and can be greater than a third coefficient of viscosity of a third filler Fm3 for filling the third shell 130, which will be described below. That is, the first coefficient of viscosity of the first filler Fm1 can be the maximum among the coefficients of viscosity of the plurality of fillers Fm1, Fm2, Fm3.

[0100] Further, the first filler Fm1 can have a first cohesive force. The cohesive force of the first filler Fm1 can be defined as an attractive force between molecules constituting the first filler Fm1 described above. For example, when the first filler Fm1 includes a first silica gel, the cohesive force of the first silica gel described above can be defined as the first cohesive force.

[0101] In an exemplary embodiment, the first cohesive force of the first filler Fm1 can be greater than a second cohesive force of a second filler Fm2 for filling the second shell 120, which will be described below, and can be greater than a third cohesive force of a third filler Fm3 for filling the third shell 130, which will be described below. That is, the first cohesive force of the first filler Fm1 can be the maximum among the cohesive forces of the plurality of fillers Fm1, Fm2, Fm3.

[0102] The breast of a human body is composed of mammary gland tissue and fatty tissue surrounding the mammary gland tissue, and thus when a person is in a supine state, the breast tends to expand in a horizontal direction perpendicular to the direction of gravity due to the action of gravity, and when the person is in a standing state, the breast tends to sag in a vertical direction parallel to the direction of gravity due to the action of gravity.

[0103] Since the first filler Fm1 in the first shell 110 of the present disclosure can have the greatest density, viscosity, and cohesive force among the fillers Fm1, Fm2, Fm3 filling the plurality of shells 110, 120, 130, the breast implant 10 of the present disclosure can achieve a motion similar to that of a human breast.

[0104] Also, since the first filler Fm1 within the first shell 110 of the present disclosure can have the largest density, viscosity, and cohesion among the fillers Fm1, Fm2, Fm3 filling the plurality of shells 110, 120, 130, the breast implant 10 of the present disclosure can achieve a similar tactile sensation to that of a human breast.

[0105] The second shell 120 can be a shell that accommodates the second filler Fm2. Specifically, the second shell 120 can be a shell that provides an internal space to accommodate the second filler Fm2, which can be a shell disposed outside the first shell 110 and inside the third shell 130.

[0106] In an exemplary embodiment, the material of the second shell 120 can include silicone. However, the material of the second shell 120 is not limited to silicone, and can also include other materials. For example, the material of the second shell 120 can include a flexible material such as rubber. In addition, the material of the second shell 120 can include an organic compound or a polymer material having biocompatibility.

[0107] The second shell 120 can be disposed inside the third shell 130, which will be described below. In an exemplary embodiment, the second shell 120 can be provided in the internal space of the third shell 130 in a state in which at least a portion of the second shell 120 is coupled to the third shell 130. For example, at least a portion of the second shell 120 can be directly coupled to the third shell 130, or at least a portion of the second shell 120 can be coupled to the third shell 130 through a separate coupling member.

[0108] In other words, at least a portion of the second shell 120 is coupled to the third shell 130, so that the second shell 120 can be disposed in the internal space of the third shell 130 in a suspended state. Thus, a portion of the second shell 120 can move freely within the internal space of the third shell 130 based on an external force or gravity generated by a body motion including the breast implant 10. For example, the motion of the plurality of shells included in the breast implant 10 of the present disclosure can be smoother compared to a breast implant composed of a single shell.

[0109] When the breast implant of the comparative example includes only the first shell and the second shell surrounding the first shell (i.e., only two shells), the second shell located at the outermost side comes into contact with the body after the breast implant is implanted in the human body, and has relatively small mobility, while the first shell located inside the second shell can have relatively large mobility due to an external force or gravity caused by a body motion.

[0110] The present disclosure provides a breast implant 10 including a plurality of shells having relatively large mobility within a human breast, thereby achieving more free breast movement and more natural breast feel. That is, the breast implant of the present disclosure can achieve more free breast movement and more natural breast feel by including more than three shells to secure the mobility of the shells disposed inside, and by making the density, viscosity, and cohesion of fillers respectively filled inside the shells different from each other, as compared to a breast implant composed of two shells. However, the present disclosure can also provide a breast implant including two shells. Figure 13 , Figure 20 The breast implant 10 of the present disclosure can include a third shell 130, a second shell 120 disposed inside the third shell 130, and a first shell 110 disposed inside the second shell 120. Accordingly, even when the third shell 130 located at the outermost side of the breast implant 10 of the present disclosure contacts the body and has relatively small mobility after being implanted in the human body, the second shell 120 disposed inside the third shell 130 can secure relatively large mobility due to external force or gravity caused by body movement, and the first shell 110 disposed inside the second shell 120 can also secure relatively large mobility due to the external force or gravity. Thus, the breast implant 10 of the present disclosure can achieve free breast movement due to body movement and gravity.

[0111] Also, since the density, viscosity, and cohesion of the fillers Fm1, Fm2, Fm3 for filling the plurality of shells 110, 120, 130 of the present disclosure can gradually increase toward the inside of the breast implant 10 (i.e., gradually decrease toward the outside of the breast implant 10), the breast implant 10 of the present disclosure can not only achieve free breast movement due to body movement and gravity, but also achieve a feel similar to breast feel.

[0112] In addition, since there are differences in the shape and size of breast tissue and fat tissue between patients who have undergone breast augmentation and breast reconstruction, the feel and shape of the breast can also be different. The breast implant 10 of the present disclosure can include more than three shells 110, 120, 130, and the density, viscosity, and cohesion of the plurality of fillers Fm1, Fm2, Fm3 for filling the plurality of shells 110, 120, 130 can be individually determined according to the breast state (e.g., the shape, size, and feel of the breast, etc.) of the patient. In other words, the materials of the plurality of fillers Fm1, Fm2, Fm3 for filling the plurality of shells 110, 120, 130 of the present disclosure can be freely determined according to the breast state of the patient.

[0113] The second filler Fm2 can be a material that fills the interior space of the second housing 120. In an exemplary embodiment, the material of the second filler Fm2 can include silica gel. Specifically, the material of the second filler Fm2 can be silica gel provided in a gel form. In addition, the material of the second filler Fm2 can also be physiological saline. However, the material of the second filler Fm2 is not limited to the above.

[0114] The second filler Fm2 can have a second density. The density of the second filler Fm2 can be defined as a mass corresponding to a unit volume of the second filler Fm2 described above. For example, when the second filler Fm2 includes second silica gel, the density of the second silica gel described above can be defined as the second density.

[0115] In an exemplary embodiment, the second density of the second filler Fm2 is less than the first density of the first filler Fm1 for filling the first housing 110 and greater than the third density of the third filler Fm3 for filling the third housing 130. That is, the second density of the second filler Fm2 can be an intermediate value among the densities of the plurality of fillers Fm1, Fm2, Fm3.

[0116] In addition, the second filler Fm2 can have a second viscosity. The viscosity of the second filler Fm2 can be defined as a thick and sticky property of the second filler Fm2 described above, and the viscosity of the second filler Fm2 can be defined as a degree of the viscosity of the second filler Fm2 described above.

[0117] In an exemplary embodiment, the second viscosity of the second filler Fm2 is less than the first viscosity of the first filler Fm1 for filling the first housing 110 and greater than the third viscosity of the third filler Fm3 for filling the third housing 130. That is, the second viscosity of the second filler Fm2 can be an intermediate value among the viscosities of the plurality of fillers Fm1, Fm2, Fm3.

[0118] For example, the viscosity coefficient of the second filler Fm2 can be defined as a numerical value of the viscosity of a liquid. For example, the second viscosity coefficient of the second filler Fm2 can be less than the first viscosity coefficient of the first filler Fm1 for filling the first housing 110 and can be greater than the third viscosity coefficient of the third filler Fm3 for filling the third housing 130. That is, the second viscosity coefficient of the second filler Fm2 can have an intermediate value among the viscosity coefficients of the plurality of fillers Fm1, Fm2, Fm3.

[0119] The second filler Fm2 can have a second cohesive force. The cohesive force of the second filler Fm2 can be defined as an attractive force between molecules constituting the second filler Fm2. For example, when the second filler Fm2 includes second silica gel, the cohesive force of the second silica gel described above can be defined as the second cohesive force.

[0120] In an exemplary embodiment, the second cohesive force of the second filler Fm2 can be less than the first cohesive force of the first filler Fm1 for filling the first shell 110, and can be greater than the third cohesive force of the third filler Fm3 for filling the third shell 130. That is, the second cohesive force of the second filler Fm2 can be an intermediate value among the cohesive forces of the plurality of fillers Fm1, Fm2, Fm3.

[0121] The third shell 130 can be a shell that accommodates the third filler Fm3. Specifically, the third shell 130 can be a shell that provides an internal space that accommodates the third filler Fm3, and can be a shell disposed at the outermost side among the plurality of shells 110, 120, 130 included in the breast implant 10 of the present disclosure.

[0122] In an exemplary embodiment, the material of the third shell 130 can include silicone. However, the material of the third shell 130 is not limited to silicone, and can include other materials. For example, the material of the third shell 130 can include a flexible material such as rubber. In addition, the material of the third shell 130 can include an organic compound or a polymer material having biocompatibility.

[0123] The third shell 130 can form an outer surface of the breast implant 10 of the present disclosure. In an exemplary embodiment, since the third shell 130 accommodates the second shell 120 in the internal space thereof, and the above-described second shell 120 accommodates the first shell 110 in the internal space thereof, when the breast implant 10 of the present disclosure is observed with the naked eye, only the third shell 130 can be observed, and the first shell 110 and the second shell 120 can not be observed.

[0124] In an exemplary embodiment, since at least a portion of the first shell 110 is disposed in a suspended state in combination with the second shell 120, and at least a portion of the second shell 120 is disposed in a suspended state in combination with the third shell 130, the first shell 110 and the second shell 120 of the present disclosure can freely move inside the third shell 130 based on an external force or gravity due to a body motion including the breast implant 10. That is, compared to a breast implant composed of a single shell, the plurality of shells of the breast implant of the present disclosure can have improved motility.

[0125] The third filler Fm3 can be a material that fills the internal space of the third shell 130. In an exemplary embodiment, the material of the third filler Fm3 can include silicone. Specifically, the material of the third filler Fm3 can be silicone provided in a gel form. In addition, the material of the third filler Fm3 can also be physiological saline. However, the material of the third filler Fm3 is not limited to the above.

[0126] The third filler Fm3 can have a third density. The density of the third filler Fm3 can be defined as a mass per unit volume of the third filler Fm3 described above. For example, if the third filler Fm3 includes a third silica gel, the density of the third silica gel described above can be defined as the third density.

[0127] In an exemplary embodiment, the third density of the third filler Fm3 can be less than the first density of the first filler Fm1 filling the first housing 110, and can be less than the second density of the second filler Fm2 filling the second housing 120. That is, the third density of the third filler Fm3 can have a minimum value among the densities of the plurality of fillers Fm1, Fm2, Fm3.

[0128] Further, the third filler Fm3 can have a third viscosity. The viscosity of the third filler Fm3 can be defined as a thick and sticky property of the third filler Fm3 described above, and the viscosity of the third filler Fm3 can be defined as a degree of viscosity of the third filler Fm3 described above.

[0129] In an exemplary embodiment, the third viscosity of the third filler Fm3 can be less than the first viscosity of the first filler Fm1 filling the first housing 110, and can be less than the second viscosity of the second filler Fm2 filling the second housing 120. That is, the third viscosity of the third filler Fm3 can have a minimum value among the viscosities of the plurality of fillers Fm1, Fm2, Fm3.

[0130] For example, the viscosity coefficient of the third filler Fm3 can be defined as a numerical value of liquid viscosity. For example, the third viscosity coefficient of the third filler Fm3 can be less than the first viscosity coefficient of the first filler Fm1 filling the first housing 110, and can be less than the second viscosity coefficient of the second filler Fm2 filling the second housing 120. That is, the third viscosity coefficient of the third filler Fm3 can have a minimum value among the viscosity coefficients of the plurality of fillers Fm1, Fm2, Fm3.

[0131] The third filler Fm3 can have a third cohesive force. The cohesive force of the third filler Fm3 can be defined as an attractive force between molecules constituting the third filler Fm3. For example, when the third filler Fm3 includes a third silica gel, the cohesive force of the third silica gel described above can be defined as the third cohesive force.

[0132] In an exemplary embodiment, the third cohesive force of the third filler Fm3 can be less than the first cohesive force of the first filler Fm1 filling the first housing 110, and can be less than the second cohesive force of the second filler Fm2 filling the second housing 120. That is, the third cohesive force of the third filler Fm3 can have a minimum value among the cohesive forces of the plurality of fillers Fm1, Fm2, Fm3.

[0133] As described above, a human breast is composed of mammary tissue and fatty tissue surrounding the mammary tissue, and thus, when a person is in a supine state, the breast tends to spread in a horizontal direction perpendicular to the direction of gravity by the action of gravity, and when the person is in a standing state, the breast tends to sag in a vertical direction parallel to the direction of gravity by the action of gravity.

[0134] The breast implant 10 of the present disclosure includes a plurality of shells 110, 120, 130, and the fillers Fm1, Fm2, Fm3 filling the plurality of shells 110, 120, 130 described above can have density, viscosity, and cohesion that increase as they approach the inside of the breast implant 10, and thus the breast implant 10 of the present disclosure can achieve a motion similar to that of a human breast.

[0135] In addition, the fillers Fm1, Fm2, Fm3 filling the plurality of shells 110, 120, 130 of the present disclosure can have density, viscosity, and cohesion that increase as they approach the inside of the breast implant 10, and thus the breast implant 10 of the present disclosure can achieve a tactile sensation similar to that of a human breast.

[0136] In an exemplary embodiment, the plurality of shells 110, 120, 130 can be provided in a shape similar to a hemisphere or an ellipsoid. When the breast implant 10 is arranged on a plane with the injection inlet 140 facing upward as shown, Figure 1 When the breast implant 10 of the present disclosure is arranged on a plane with the injection inlet 140 facing upward, the first shell 110 and the second shell 120 arranged inside the third shell 130 can be provided in a hemispherical or ellipsoidal shape in which the horizontal cross-sectional area gradually increases from the bottom upward by the action of gravity and then gradually decreases from a predetermined interval.

[0137] In addition, when the breast implant 10 of the present disclosure is arranged on a plane with the injection inlet 140 facing upward, the first shell 110 and the second shell 120 arranged inside the third shell 130 can be provided in a hemispherical or ellipsoidal shape in which the horizontal cross-sectional area gradually increases from the bottom upward by the action of gravity and then gradually decreases from a predetermined interval.

[0138] In an exemplary embodiment, the volume of the first shell 110 can be about 10% to about 25% of the total volume of the breast implant 10. In addition, the volume of the second shell 120 can be about 25% to about 30% of the total volume of the breast implant 10. In addition, the volume of the third shell 130 can be about 45% to about 65% of the total volume of the breast implant 10. However, the volume ratio of the first to third shells 110, 120, 130 is not limited to the above values.

[0139] The injection port 140 can provide a space for injecting the fillers Fm1, Fm2, Fm3 into the plurality of shells 110, 120, 130. In an exemplary embodiment, the injection port 140 can be provided at a portion where the plurality of shells 110, 120, 130 are combined with each other (i.e., a contact portion). For example, when the breast implant 10 is arranged on a plane, the injection port 140 can be provided at an uppermost end of the breast implant 10 of the present disclosure.

[0140] Further, the breast implant 10 of the present disclosure can be provided in a shape similar to that of a human breast. At this time, the injection port 140 of the breast implant 10 can correspond to a human areola portion or a portion adjacent to the areola portion. In the present specification, the injection port 140 of the breast implant 10 corresponding to the human areola portion means that the injection port 140 corresponds to a portion where the areola is formed or a portion where subareolar tissue (e.g., subareolar breast tissue) is located. For example, the injection port 140 of the breast implant 10 can correspond to the human areola portion and can be arranged at a portion adjacent to the subareolar tissue (e.g., subareolar breast tissue).

[0141] That is, when the breast implant 10 is implanted in a human body, the injection port 140 of the breast implant 10 can be provided at the areola portion of the human body or a portion adjacent to the areola portion.

[0142] The areola portion exhibits a relatively darker color than the surrounding skin of the body. After the breast implant 10 is implanted in a human body, for various reasons such as patient discomfort and pain, a situation can occur where the fillers Fm1, Fm2, Fm3 inside the plurality of shells 110, 120, 130 need to be controlled by injection or aspiration.

[0143] At this time, since the injection port 140 of the breast implant 10 can be located at the areola portion of the human body and the adjacent portion, in order to control the fillers Fm1, Fm2, Fm3 inside the breast implant 10, even if a portion of the areola portion or the skin adjacent to the areola portion is partially incised, the degree of scar visibility can be minimized due to the darker color of the areola.

[0144] As for the structure of the injection port 140 of the breast implant 10 of the present disclosure, reference is made to Figure 2 for a more detailed description.

[0145] Although the breast implant 10 of the present disclosure is illustrated as including three shells 110, 120, 130, it is not limited thereto, and the breast implant 10 of the present disclosure can include four or more shells.

[0146] Figure 2 To show a view of the injection port 140 from a planar angle. Figure 1

[0147] Reference is made to​Figure 2 The injection port 140 of the breast implant 10 of the present disclosure can include a first injection port 141, a second injection port 143, and a third injection port 145.

[0148] The first injection port 141 can be a space provided to inject the first filler Fm1 into the first shell 110. In an exemplary embodiment, the first injection port 141 can be disposed at the innermost side among the plurality of injection ports 141, 143, 145. For example, the first injection port 141 can be provided in a circular shape.

[0149] The second injection port 143 can be a space provided to inject the second filler Fm2 into the second shell 120. For example, the second injection port 143 can be provided in an annular shape around the first injection port 141.

[0150] In an exemplary embodiment, the second injection port 143 can be disposed at the middle portion among the plurality of injection ports 141, 143, 145. That is, the second injection port 143 can be disposed at the outer side of the first injection port 141 and at the inner side of the third injection port 145.

[0151] The third injection port 145 can be a space provided to inject the third filler Fm3 into the third shell 130. In an exemplary embodiment, the third injection port 145 can be disposed at the outermost side among the plurality of injection ports 141, 143, 145. For example, the third injection port 145 can be provided in an annular shape around the second injection port 143.

[0152] In an exemplary embodiment, after the fillers Fm1, Fm2, Fm3 are filled into the plurality of shells 110, 120, 130 through the plurality of first to third injection ports 141, 143, 145, the plurality of first to third injection ports 141, 143, 145 can be closed by a sealing member.

[0153] In an exemplary embodiment, the sealing member can include an adhesive label easily adhered to the plurality of shells 110, 120, 130. For example, the sealing member can include a sticker-type adhesive label, and an area of the sticker-type adhesive label can be greater than areas of the plurality of first to third injection ports 141, 143, 145 to close the first to third injection ports 141, 143, 145. However, the type of the sealing member is not limited to the above.

[0154] In an exemplary embodiment, the sealing member can include a silicone material. For example, the sealing member can be a sticker-type adhesive label composed of a silicone material. However, the material of the sealing member is not limited to the above.

[0155] Figure 3 A diagram to show the breast implant 10 of the present disclosure disposed in a breast of a patient who has undergone breast reconstruction surgery.

[0156] Generally, when a breast cancer patient undergoes a mastectomy, breast tissue of the breast can be removed. Thus, the patient who has undergone the mastectomy usually undergoes a breast reconstruction surgery using a breast implant to create a new breast similar to the actual breast thereof.

[0157] Referring to Figure 3 The breast implant 10 of the present disclosure can be implanted inside a breast of a patient. Specifically, the breast implant 10 of the present disclosure can be implanted inside a breast of a patient so that the injection port 140 of the breast implant 10 of the present disclosure corresponds to an areola site Ar of the patient.

[0158] The injection port 140 of the breast implant 10 can be disposed to correspond to the areola site ar of the human body and an adjacent site thereof, and thus, even if a skin of the areola site Ar is partially incised for controlling the fillers Fm1, Fm2, Fm3 within the breast implant 10, a degree of exposure of a scar can be minimized due to a deep color of the areola site.

[0159] In an exemplary embodiment, the third shell 130 of the breast implant 10 can form an overall appearance of a breast. For example, a filling amount of the third filler Fm3 can be determined according to a breast size and shape desired by a patient, and when the third filler Fm3 is filled inside the third shell 130, the third shell 130 can form an appearance of a breast.

[0160] In addition, as the first shell 110 and the second shell 120 are filled with the first filler Fm1 and the second filler Fm2, respectively, the first shell 110 and the second shell 120 can freely move in an inner space of the third shell 130 based on an external force or gravity generated by a body motion. That is, compared to a breast implant constituted by a single shell, the plurality of shells of the breast implant of the present disclosure can have improved motility.

[0161] In an exemplary embodiment, the first filler Fm1 and the second filler Fm2 filled in the first shell 110 and the second shell 120 can be silicone, and the third filler Fm3 filled in the third shell 130 can be physiological saline. Since the third shell 130 forming an appearance of the breast implant 10 of the present disclosure is filled with physiological saline, even if the third filler Fm3 leaks due to damage of the third shell 130 by an external impact, the third filler Fm3 can be absorbed by the human body, thereby reducing a ratio of occurrence of capsular contracture. In addition, a psychological stress of a patient on rupture of the breast implant can be reduced.

[0162] In an exemplary embodiment, the density, viscosity, and cohesion of the physiological saline used to fill the third shell 130 can each be less than the density, viscosity, and cohesion of the silicone used to fill the first shell 110 and the second shell 120. In addition, the density of the silicone used to fill the second shell 120 can be less than the density of the silicone used to fill the first shell 110.

[0163] That is, the breast implant 10 of the present disclosure includes a plurality of shells 110, 120, 130, and the fillers Fm1, Fm2, Fm3 filling the plurality of shells 110, 120, 130 can have higher density, viscosity, and cohesion as they are closer to the inside of the breast implant 10, and thus the breast implant 10 of the present disclosure can achieve similar movement and tactile sensation to the human breast.

[0164] Figure 4 A diagram showing the breast implant 10 of the present disclosure disposed in the breast of a person who has undergone breast augmentation according to an exemplary embodiment of the present disclosure.

[0165] Unlike a patient who has undergone breast reconstruction due to breast cancer surgery, a person who has undergone breast augmentation for cosmetic or the like purposes can have breast tissue Ti. Referring to Figure 4 , the breast implant 10 of the present disclosure can be disposed in the space G provided inside the breast tissue Ti. Specifically, to make the injection port 140 of the breast implant 10 of the present disclosure correspond to the areola site Ar of the patient, the breast implant 10 of the present disclosure can be implanted in the space G provided inside the breast tissue Ti.

[0166] However, the present disclosure is not limited thereto, and the breast implant 10 can be implanted in any layer of the human body. For example, the breast implant 10 can be implanted subfascially or submuscularly.

[0167] The injection port 140 of the breast implant 10 can be disposed to correspond to the areola site Ar of the human body and its adjacent site, and thus, even if the skin of the areola site Ar is partially incised to control the fillers Fm1, Fm2, Fm3 inside the breast implant 10, the degree of scar visibility can be minimized due to the deep color of the areola site.

[0168] In an exemplary embodiment, the third shell 130 of the breast implant 10 can control the size and shape of the breast appearance. For example, the filling amount of the third filler Fm3 can be determined according to the breast size and shape desired by the patient, and when the third filler Fm3 is filled inside the third shell 130, the third shell 130 can form the appearance of the breast.

[0169] In addition, as the first housing 110 and the second housing 120 are filled with the first filler Fm1 and the second filler Fm2, respectively, the first housing 110 and the second housing 120 can freely move in the internal space of the third housing 130 based on an external force or gravity generated by a body movement. That is, compared to a breast implant composed of a single housing, the breast implant of the present disclosure can have improved motility.

[0170] In an exemplary embodiment, the material of the first filler Fm1 and the second filler Fm2 filled in the first housing 110 and the second housing 120 can be silicone, and the material of the third filler Fm3 filled in the third housing 130 can be physiological saline. The third housing 130 forming the appearance of the breast implant 10 of the present disclosure can be filled with physiological saline, so that even if the third housing 130 is damaged due to an external impact, causing the third filler Fm3 to leak, the third filler Fm3 can be absorbed by the human body, thereby reducing the incidence of capsular contracture. In addition, the psychological stress of the patient on the rupture of the breast implant can also be reduced.

[0171] In an exemplary embodiment, the density, viscosity, and cohesion of the physiological saline used to fill the third housing 130 can each be less than the density, viscosity, and cohesion of the silicone used to fill the first housing 110 and the second housing 120. In addition, the density of the silicone used to fill the second housing 120 can be less than the density of the silicone used to fill the first housing 110.

[0172] That is, the breast implant 10 of the present disclosure includes a plurality of housings 110, 120, 130, and the fillers Fm1, Fm2, Fm3 filling the plurality of housings 110, 120, 130 can have higher density, viscosity, and cohesion the closer they are to the inside of the breast implant 10, so the breast implant 10 of the present disclosure can achieve similar movement and tactile sensation to the human breast.

[0173] Figure 5 To show the position of the body incised for breast augmentation and breast reconstruction surgery. In addition, Figure 6 To show a breast implant 10 in which fillers are filled in some of the plurality of housings.

[0174] Referring to Figure 5 For breast augmentation and breast reconstruction surgery, at least one of the axillary portion Ta, the areola portion Ar, the lower chest portion Ma, and the navel portion Um of the human body can be incised.

[0175] In surgery for implanting a general breast implant into a human body, the patient's skin needs to be incised by about 5 cm or more due to the volume of the breast implant. These body incisions can reduce the patient's satisfaction with beauty.

[0176] Referring to Figure 6 In order to perform breast augmentation and breast reconstruction, the first shell 110 and the second shell 120 of the breast implant 10 of the present disclosure can be provided in a state of being filled with the first filler Fm1 and the second filler Fm2, and the third shell 130 can be provided in a state of not being filled with the third filler Fm3. The materials of the first filler Fm1 and the second filler Fm2 described above can be silicone.

[0177] In the exemplary embodiment, after the breast implant 10, in which the first shell 110 and the second shell 120 have been filled with the first filler Fm1 and the second filler Fm2, is implanted into a patient's body during the performance of breast augmentation and breast reconstruction, the third filler Fm3 can be filled into the third shell 130 through the injection port 140.

[0178] Since the breast implant 10 of the present disclosure includes a plurality of shells 110, 120, 130, and only a portion of the plurality of shells 110, 120 is in a state of being filled with the filler Fm1, Fm2, the breast implant 10 described above can be implanted into a human body, and thus, when the breast implant 10 of the present disclosure is implanted into a human body, the volume (i.e., size) of the breast implant 10 can be reduced. Thereby, the range of skin incision for breast augmentation and breast reconstruction can be reduced, thereby improving the cosmetic satisfaction of a patient.

[0179] However, the present disclosure is not limited thereto, and the breast implant 10 described above can be implanted into a human body in a state in which the plurality of shells 110, 120, 130 have all been filled with the filler Fm1, Fm2, Fm3. At this time, the breast implant 10 is implanted into a body in a state in which the outermost shell 130 is filled with physiological saline, and thus, the size of a scar of a patient's incision can be reduced, thereby improving cosmetic satisfaction.

[0180] Further, as described above, the injection port 140 of the present disclosure can allow the breast implant 10 to be disposed at a position corresponding to the areola region Ar and an adjacent region of a human body, and even if the skin of the areola region Ar is partially incised to fill the third filler Fm3 into the third shell 130 through the injection port 140, the degree of exposure of a scar can be minimized due to the dark color of the areola region Ar described above.

[0181] Figure 7 A diagram showing a breast in which the breast implant 10' according to the comparative example is implanted. Figure 8 A diagram showing a breast in which the breast implant 10 of the present disclosure is implanted.

[0182] Referring to Figure 7According to the comparative example, the breast implant 10' can be an implant including one shell and a filler filled in the shell. Since the breast implant 10' according to the comparative example is composed of one shell, it is difficult to achieve a natural breast shape, and the density inside is uniform, so that an artificial feeling is generated, thereby reducing the satisfaction of the patient.

[0183] The breast of a human body is composed of mammary tissue and fat tissue. Specifically, the inner side of the breast has a relatively high density due to the mammary tissue and the like, and the outer side of the breast has a relatively low density due to the fat tissue. Accordingly, when a person is in a standing state, the breast tends to sag in a vertical direction parallel to the direction of gravity due to the effect of gravity. The breast implant 10' according to the comparative example does not sag downward even though it is affected by gravity because the density inside the shell is not uniform, and thus a natural breast shape cannot be achieved.

[0184] Referring to Figure 8 Since the breast implant 10 of the present disclosure includes a plurality of shells 110, 120, 130, and the fillers Fm1, Fm2, Fm3 for filling the plurality of shells 110, 120, 130 can have a density, a viscosity, and a cohesion that are higher as they are closer to the inner side of the breast implant 10, the breast implant 10 of the present disclosure can achieve a motion similar to that of a human breast. That is, when a person holding the breast implant 10 of the present disclosure is in a standing state, the plurality of shells 110, 120, 130 of the breast implant 10 of the present disclosure sag in a direction parallel to the direction of gravity due to the effect of gravity, thereby achieving a natural breast shape.

[0185] In addition, the fillers Fm1, Fm2, Fm3 filling the plurality of shells 110, 120, 130 of the present disclosure can have a density, a viscosity, and a cohesion that increase as they are closer to the inside of the breast implant 10, and thus the breast implant 10 of the present disclosure can achieve a feeling similar to that of a human breast.

[0186] Figure 9 A diagram showing a breast in which the breast implant 10' according to the comparative example is implanted. In addition, Figure 10 A diagram showing a breast in which the breast implant 10 of the present disclosure is implanted.

[0187] Referring to Figure 9 According to the comparative example, the breast implant 10' can be an implant including one shell and a filler filled in the shell. According to the comparative example, the breast implant 10' is composed of a single shell, it is difficult to achieve a natural breast shape, and the density inside is uniform, so that the satisfaction of the patient is reduced due to an artificial feeling.

[0188] When a person is in a supine position, the breasts tend to sag in a direction parallel to the direction of gravity. The breast implant according to the comparative example, since the density inside the shell is uniform, the breasts do not sag horizontally even though affected by gravity, and a natural breast shape cannot be achieved.

[0189] Referring to Figure 10 The breast implant 10 of the present disclosure includes a plurality of shells 110, 120, 130, and the fillers Fm1, Fm2, Fm3 filling the plurality of shells 110, 120, 130 described above can have density, viscosity, and cohesion that increase as they approach the inside of the breast implant 10 described above, and thus the breast implant 10 of the present disclosure can achieve a motion similar to that of a human breast. That is, when a person holding the breast implant 10 of the present disclosure is in a supine position, the plurality of shells 110, 120, 130 of the breast implant 10 of the present disclosure sag in a direction perpendicular to the direction of gravity under the action of gravity, thereby achieving a natural breast shape.

[0190] In addition, the fillers Fm1, Fm2, Fm3 filling the plurality of shells 110, 120, 130 of the present disclosure can have density, viscosity, and cohesion that increase as they approach the inside of the breast implant 10 described above, and thus the breast implant 10 of the present disclosure can achieve a tactile sensation similar to that of a human breast.

[0191] Figure 11 To show a flowchart of the flow of the manufacturing method 10a of the breast implant 10 according to an exemplary embodiment of the present disclosure.

[0192] Referring to Figure 11 The manufacturing method S10a of the breast implant 10 of the present disclosure can include a step S100a of inserting the first shell 110 into the second shell 120, a step S200a of inserting the second shell 120 into the third shell 130, a step S300a of filling the fillers into the first shell 110, the second shell 120, and the third shell 130 through the injection ports 140, respectively, and a step S400a of sealing the injection ports 140.

[0193] In the step S100a, the first shell 110 can be inserted into the inner space of the second shell 120. In addition, when the first shell 110 is inserted into the inner space of the second shell 120, at least a portion of the first shell 110 can be combined with the second shell 120. Thus, the first shell 110 can be disposed in a suspended state in the inner space of the second shell 120.

[0194] In step S200a, the second case 120 including the first case 110 can be inserted into the inner space of the third case 130. Also, after the second case 120 is inserted into the inner space of the third case 130, at least a portion of the second case 120 can be combined with the third case 130. Thus, the second case 120 can be disposed in the inner space of the third case 130 in a suspended state, and the first case 110 can be disposed in the inner space of the second case 120 in a suspended state.

[0195] In step S300a, the first filler Fm1, the second filler Fm2, and the third filler Fm3 can be filled into the first case 110, the second case 120, and the third case 130, respectively, through the injection ports 140.

[0196] In an exemplary embodiment, the first filler Fm1 can be filled into the first case 110 through the first injection port 141, the second filler Fm2 can be filled into the second case 120 through the second injection port 143, and the third filler Fm3 can be filled into the third case 130 through the third injection port 145.

[0197] In step S400a, the injection ports can be sealed to prevent the fillers from entering. In an exemplary embodiment, if the plurality of fillers Fm1, Fm2, and Fm3 are filled into the plurality of cases 110, 120, and 130 through the plurality of first to third injection ports 141, 143, and 145, the plurality of first to third injection ports 141, 143, and 145 can be closed by the sealing member.

[0198] In an exemplary embodiment, the sealing member can include an adhesive label easily adhered to the plurality of cases 110, 120, and 130. For example, the sealing member can include a sticker-type adhesive label, and the area of the sticker-type adhesive label can be greater than the area of the plurality of first to third injection ports 141, 143, and 145 to close the first to third injection ports 141, 143, and 145. However, the type of the sealing member is not limited to the above.

[0199] Figure 12 A flowchart showing a flow of a manufacturing method 10b of the breast implant 10 according to an exemplary embodiment of the disclosure.

[0200] Referring to Figure 12The manufacturing method S10b of the breast implant 10 of the present disclosure can include a step S100b of filling the first shell 110 with a first filler Fm1, a step S200b of inserting the first shell 110 into the second shell 120, a step S300b of filling the second shell 120 with a second filler Fm2, a step S400b of inserting the second shell 120 into the third shell 130, and a step S500b of filling the third shell 130 with a third filler.

[0201] In the step S100b, the first filler Fm1 can be filled into the first shell 110 through the first injection inlet 141. In addition, after the first filler Fm1 is filled into the first shell 110, the first injection inlet 141 can be closed by a sealing member.

[0202] In the step S200b, the first shell 110 can be inserted into the inner space of the second shell 120. In addition, when the first shell 110 is inserted into the inner space of the second shell 120, at least a portion of the first shell 110 can be combined with the second shell 120. Accordingly, the first shell 110 can be disposed in a suspended state in the inner space of the second shell 120.

[0203] In the step S300b, the second filler Fm2 can be filled into the second shell 120 through the second injection inlet 143. In addition, after the second filler Fm2 is filled into the second shell 120, the second injection inlet 143 can be closed by a sealing member.

[0204] In the step S400b, the second shell 120 can be inserted into the inner space of the third shell 130. In addition, when the second shell 120 is inserted into the inner space of the third shell 130, at least a portion of the second shell 120 can be combined with the third shell 130. Accordingly, the second shell 120 can be disposed in a suspended state in the inner space of the third shell 130, and the first shell 110 can be disposed in a suspended state in the inner space of the second shell 120.

[0205] In the step S500b, the third filler Fm3 can be filled into the third shell 130 through the third injection inlet 145. In addition, after the third filler Fm3 is filled into the third shell 130, the third injection inlet 145 can be closed by a sealing member.

[0206] Figure 13 A diagram of a breast implant 20 according to an exemplary embodiment of the present disclosure is shown.

[0207] Referring to Figure 13 The breast implant 20 of the present disclosure can include a first shell 210, a second shell 220, a first filler Fm1a, a second filler Fm2a, and an injection inlet 240, etc.

[0208] The first shell 210 can be a shell for accommodating the first filler Fm1a. Specifically, the first shell 210 can be a shell providing an inner space for accommodating the first filler Fm1a, and can be a shell disposed at the innermost side among the plurality of shells 210, 220 included in the breast implant 20 of the present disclosure.

[0209] In an exemplary embodiment, the material of the first shell 210 can include silicone. However, the material of the first shell 210 is not limited to silicone, and can also include other materials. For example, the material of the first shell 210 can include a flexible material such as rubber. In addition, the material of the first shell 210 can include an organic compound or a polymer material having biocompatibility.

[0210] The first shell 210 can be disposed inside the second shell 220 which will be described below. In an exemplary embodiment, the first shell 210 can be provided in the inner space of the second shell 220 in a state in which at least a portion of the first shell 210 is combined with the second shell 220. For example, at least a portion of the first shell 210 can be directly combined with the second shell 220, or at least a portion of the first shell 210 can be combined with the second shell 220 through a separate combining member.

[0211] In other words, at least a portion of the first shell 210 is combined with the second shell 220, so that the first shell 210 described above can be disposed in a suspended state in the inner space of the second shell 220. Thus, a portion of the first shell 210 can move freely within the inner space of the second shell 220 based on an external force or gravity generated by the movement of the body including the breast implant 20 of the present disclosure. For example, the movement of the plurality of shells included in the breast implant 20 of the present disclosure can be more smooth compared to a breast implant composed of a single shell.

[0212] The first filler Fm1a can be a material filling the inner space of the first shell 210. In an exemplary embodiment, the material of the first filler Fm1a can include silicone. Specifically, the first filler Fm1a can be silicone provided in a gel form. In addition, the material of the first filler Fm1a can also be physiological saline. However, the material of the first filler Fm1a is not limited to the above.

[0213] The first filler Fm1a can have a first density. The density of the first filler Fm1a can be defined as a mass corresponding to a unit volume of the first filler Fm1a described above. For example, when the first filler Fm1a includes first silicone, the density of the first silicone described above can be defined as the first density.

[0214] In an exemplary embodiment, the first density of the first filler Fm1a can be greater than a second density of a second filler Fm2a for filling a second housing 220 to be described below.

[0215] Further, the first filler Fm1a can have a first viscosity. The viscosity of the first filler Fm1a can be defined as a viscous property of the first filler Fm1a described above, and the viscosity of the first filler Fm1a can be defined as a degree of viscosity of the first filler Fm1a described above. For example, a greater viscosity indicates a higher resistance to the flow of fluid, and a smaller viscosity indicates a lower resistance to the flow of fluid.

[0216] In an exemplary embodiment, the first viscosity of the first filler Fm1a can be greater than a second viscosity of a second filler Fm2a for filling a second housing 220 to be described below.

[0217] For example, the viscosity coefficient of the first filler Fm1a can be defined as a numerical value of the viscosity of a liquid. For example, the first viscosity coefficient of the first filler Fm1a can be greater than a second viscosity coefficient of a second filler Fm2a for filling a second housing 220 to be described below.

[0218] Further, the first filler Fm1a can have a first cohesive force. The cohesive force of the first filler Fm1a can be defined as an attractive force between molecules constituting the first filler Fm1a described above. For example, when the first filler Fm1a includes a first silica gel, the cohesive force of the first silica gel described above can be defined as the first cohesive force.

[0219] In an exemplary embodiment, the first cohesive force of the first filler Fm1a can be greater than a second cohesive force of a second filler Fm2a for filling a second housing 220 to be described below.

[0220] The breast of a human body is composed of mammary gland tissue and fatty tissue surrounding the mammary gland tissue, and thus when a person is in a supine state, the breast tends to expand in a horizontal direction perpendicular to the direction of gravity due to the action of gravity, and when a person is in a standing state, the breast tends to sag in a vertical direction parallel to the direction of gravity due to the action of gravity.

[0221] Since the first filler Fm1a in the first housing 210 of the present disclosure can have the greatest density, viscosity, and cohesive force among the fillers Fm1a, Fm2a for filling a plurality of housings 210, 220, the breast implant 20 of the present disclosure is capable of achieving a motion similar to that of a human breast.

[0222] Further, since the first filler Fm1a within the first shell 210 of the present disclosure can have the greatest density, viscosity, and cohesion among the fillers Fm1a, Fm2a for filling the plurality of shells 210, 220, the breast implant 20 of the present disclosure can also achieve a similar tactile sensation to that of a human breast.

[0223] The second shell 220 can be a shell that accommodates the second filler Fm2a. Specifically, the second shell 220 can be a shell that provides an internal space for accommodating the second filler Fm2a.

[0224] In an exemplary embodiment, the material of the second shell 220 can include silicone. However, the material of the second shell 220 is not limited to silicone, and can also include other materials. For example, the material of the second shell 220 can include a flexible material such as rubber. In addition, the material of the second shell 220 can include an organic compound or a polymer material having biocompatibility.

[0225] The breast implant 20 of the present disclosure can include the second shell 220 and the first shell 210 disposed inside the above-described second shell 220. Accordingly, even after the breast implant 20 of the present disclosure is implanted in the human body, the second shell 220 located at the outermost side contacts the body and has relatively small motility, and the first shell 210 disposed inside the second shell 220 can ensure relatively large motility due to external force or gravity caused by body movement. Thus, the breast implant 20 of the present disclosure can achieve free breast movement due to body movement and gravity.

[0226] Further, the density, viscosity, and cohesion of the fillers Fm1a, Fm2a for filling the plurality of shells 210, 220 of the present disclosure can be higher toward the inner side of the breast implant 20 (i.e., lower toward the outer side of the breast implant 20), and thus the breast implant 20 of the present disclosure can not only achieve free breast movement under the effects of body movement and gravity, but also achieve a tactile sensation similar to that of a breast.

[0227] Further, since there are differences in the shape and size of breast tissue and fat tissue between patients who have undergone breast augmentation and breast reconstruction, the tactile sensation and shape of the breast can also differ. The breast implant 20 of the present disclosure can include a plurality of shells 210, 220, and the density, viscosity, and cohesion of the plurality of fillers Fm1a, Fm2a for filling the above-described plurality of shells 210, 220 can be determined individually according to the breast state (e.g., the shape, size, and tactile sensation of the breast, etc.) of the patient. In other words, the materials of the plurality of fillers Fm1a, Fm2a for filling the plurality of shells 210, 220 of the present disclosure can be freely determined according to the breast state of the patient.

[0228] The second filler Fm2a can be a material that fills the interior space of the second housing 220. In an exemplary embodiment, the material of the second filler Fm2a can include silica gel. Specifically, the material of the second filler Fm2a can be silica gel provided in a gel form. In addition, the material of the second filler Fm2a can also be physiological saline. However, the material of the second filler Fm2a is not limited to the above.

[0229] The second filler Fm2a can have a second density. The density of the second filler Fm2a can be defined as a mass corresponding to a unit volume of the above-described second filler Fm2a. For example, when the second filler Fm2a includes second silica gel, the density of the above-described second silica gel can be defined as the second density.

[0230] In an exemplary embodiment, the second density of the second filler Fm2a can be less than the first density of the first filler Fm1a used to fill the first housing 210. For example, if the first filler Fm1a includes silica gel having a first density, the second filler Fm2a can include silica gel having a second density less than the first density.

[0231] However, it is not limited thereto, and when the first filler Fm1a includes silica gel having a first density, the second filler Fm2a can include physiological saline having a second density less than the first density.

[0232] In addition, the second filler Fm2a can have a second viscosity. The viscosity of the second filler Fm2a can be defined as a thick and sticky property of the above-described second filler Fm2a, and the viscosity of the second filler Fm2a can be defined as a degree of viscosity of the above-described second filler Fm2a.

[0233] In an exemplary embodiment, the second viscosity of the second filler Fm2a can be less than the first viscosity of the first filler Fm1a used to fill the first housing 210.

[0234] The second filler Fm2a can have a second cohesive force. The cohesive force of the second filler Fm2a can be defined as an attractive force between molecules constituting the above-described second filler Fm2a. For example, when the second filler Fm2a includes second silica gel, the cohesive force of the above-described second silica gel can be defined as the second cohesive force.

[0235] In an exemplary embodiment, the second cohesive force of the second filler Fm2a can be less than the first cohesive force of the first filler Fm1a used to fill the first housing 210.

[0236] The injection port 240 can provide a space for injecting the fillers Fm1a, Fm2a into the plurality of shells 210, 220. In an exemplary embodiment, the injection port 240 can be provided at a portion where the plurality of shells 210, 220 are combined with each other (i.e., a contact portion). For example, when the breast implant 20 is arranged on a plane, the injection port 240 can be provided at an uppermost end of the breast implant 20 of the present disclosure.

[0237] The injection port 240 of the breast implant 20 of the present disclosure can include a first injection port providing a path for injecting the first filler Fm1a into the first shell 210, and a second injection port provided in a shape surrounding the first injection port and providing a path for injecting the second filler Fm2a into the second shell 220.

[0238] Further, the breast implant 20 of the present disclosure can be provided in a shape similar to that of a human breast. At this time, the injection port 240 of the breast implant 20 can correspond to a portion of the human body at or adjacent to an areola portion. That is, when the breast implant 20 is inserted into the human body, the injection port 240 of the breast implant 20 can be provided at a portion of the human body at or adjacent to the areola portion.

[0239] The areola portion exhibits a relatively darker color than the surrounding skin of the body. After the breast implant 20 is implanted in the human body, for various reasons such as patient discomfort, pain, etc., it can be necessary to control injection or aspiration of the fillers Fm1a, Fm2a inside the plurality of shells 210, 220.

[0240] At this time, since the injection port 240 of the breast implant 20 can be located at a portion corresponding to the areola portion and the adjacent portion of the human body, even if a portion of the skin at the areola portion or the adjacent portion is partially incised for the purpose of controlling the fillers Fm1a, Fm2a inside the breast implant 20, the degree of exposure of a scar can be minimized due to the darker color of the areola portion.

[0241] The breast implant 20 of the present disclosure includes the plurality of shells 210, 220, and can be implanted in the human body with only a portion of the plurality of shells 210, 220 in a state where the portion has been filled with the fillers Fm1a, and thus the volume (i.e., size) of the breast implant 20 can be reduced when the breast implant 20 of the present disclosure is implanted in the human body. As a result, the range of skin incision for breast augmentation and breast reconstruction can be reduced, thereby improving the cosmetic satisfaction of the patient.

[0242] For example, the breast implant 20 can be inserted into the human body in a state in which the first filler Fm1a containing silicone gel is filled into the first case 210. Accordingly, the volume of the breast implant 20 can be reduced when the breast implant 20 is inserted into the human body. Accordingly, the skin incision range for breast augmentation and breast reconstruction can be reduced. In addition, after the breast implant 20 is implanted into the human body, the second filler Fm2a containing physiological saline can be filled inside the second case 220.

[0243] Also, since the second case 220 forming the appearance of the breast implant 20 of the present disclosure can be filled with physiological saline, even if the above-described second case 220 is damaged by external impact, causing the second filler Fm2a to leak, the above-described second filler Fm2a can be absorbed by the human body, thereby reducing the incidence of capsular contracture and alleviating the psychological stress of the patient on the rupture of the breast implant 20.

[0244] The breast implant 20 of the present disclosure is not limited to the contents described with reference to Figure 13 , but can include all technical ideas described with reference to Figures 1 to 12 .

[0245] Figure 14 FIG. 1 is a diagram to show the structure of a breast implant 10 of the present disclosure. In addition, Figure 15 FIG. 2 is a diagram to show the flow of a plurality of cases in the breast implant 10 of the present disclosure.

[0246] Hereinafter, the repeated contents of the breast implant 10, 20 described with reference to Figures 1 to 13 will be omitted, and the differences will be mainly described. Figure 14 and Figure 15 .

[0247] Meanwhile, with reference to Figure 14 and Figure 15 , the breast implant 10_I of the present disclosure can include a first case 110_I, a second case 120_I, and a third case 130_I, etc.

[0248] In an exemplary embodiment, the first case 110_I can be provided in a shape similar to a water bag (for example, a water balloon shape) in which the inlet portion into which the first filler is injected is sagged.

[0249] Specifically, the first housing 110_I can include a first hanging portion 110a_I and a first filling portion 110b_I. The first hanging portion 110a_I can be a portion of the first housing 110_I for allowing the first filling portion 110b_I, which will be described below, to be disposed inside the second housing 120_I in a hanging manner. Also, the first filling portion 110b_I can be disposed inside the second housing 120_I in a hanging manner through the first hanging portion 110a_I, and can be a portion of the first housing 110_I that accommodates a first filler in an internal space thereof.

[0250] In an exemplary embodiment, the first hanging portion 110a_I can be provided in conjunction with an injection port (not shown in the drawings) or at least a portion of the second housing 120_I. Also, the first filling portion 110b_I can be integrated with the first hanging portion 110a_I. For example, the first filling portion 110b_I and the first hanging portion 110a_I can substantially include the same material.

[0251] Further, in an exemplary embodiment, when the breast implant 10_I of the present disclosure is arranged on a plane in a state in which the injection port faces upward, a cross-sectional area of the first hanging portion 110a_I of the first housing 110_I in a horizontal direction can be smaller than a cross-sectional area of the first filling portion 110b_I in the horizontal direction.

[0252] Since the first housing 110_I includes the first hanging portion 110a_I and the first filling portion 110b_I described above, the first filling portion 110b_I of the first housing 110_I of the present disclosure can be disposed inside the second housing 120_I in a hanging manner through the first hanging portion 110a_I. Thereby, the mobility of the first filling portion 110b_I based on an external force or gravity can be improved.

[0253] The second housing 120_I can be provided in a shape similar to a water bag (e.g., a water ball) in which an inlet portion into which a second filler is injected is sagged.

[0254] Specifically, the second housing 120_I can include a second hanging portion 120a_I and a second filling portion 120b_I. The second hanging portion 120a_I can be a portion of the second housing 120_I for allowing the second filling portion 120b_I, which will be described below, to be disposed inside the third housing 130_I in a hanging manner. Also, the second filling portion 120b_I can be disposed inside the third housing 130_I in a hanging manner through the second hanging portion 120a_I, and can be a portion of the second housing 120_I that accommodates a second filler in an internal space thereof.

[0255] In an exemplary embodiment, the second hanging portion 120a_I can be provided in conjunction with an injection port (not shown in the drawings) or at least a portion of the third case 130_I. Also, the second filling portion 120b_I can be connected to the second hanging portion 120a_I to form one body. For example, the second filling portion 120b_I and the second hanging portion 120a_I can substantially contain the same material.

[0256] Also, in an exemplary embodiment, when the breast implant 10_I of the present disclosure is disposed on a plane in a state in which the injection port faces upward, a cross-sectional area of the second hanging portion 120a_I of the second case 120_I in a horizontal direction can be smaller than a cross-sectional area of the second filling portion 120b_I in the horizontal direction.

[0257] Since the second case 120_I includes the second hanging portion 120a_I and the second filling portion 120b_I described above, the second filling portion 120b_I of the second case 120_I of the present disclosure can be disposed in a hanging form inside the third case 130_I through the second hanging portion 120a_I. Thereby, the mobility of the second filling portion 120b_I based on an external force or gravity can be improved.

[0258] That is, the breast implant 10_I of the present disclosure includes the first case 110_I including the first hanging portion 110a_I and the first filling portion 110b_I and the second case 120_I including the second hanging portion 120a_I and the second filling portion 120b_I, and thereby the mobility of the first case 110_I and the second case 120_I under an external force or gravity due to a body movement can be improved.

[0259] Figure 16 To show a flowchart of a flow of a manufacturing method S10 of a breast implant according to an exemplary embodiment of the present disclosure.

[0260] The manufacturing method S10 of the breast implant of the present disclosure can be a method of manufacturing a breast implant including a plurality of cases. Specifically, the manufacturing method of the breast implant of the present disclosure can be a method of manufacturing a breast implant in which a second case is inserted inside a first case and is in a hanging structure.

[0261] Referring to Figure 16The manufacturing method S10 of a breast implant according to an exemplary embodiment of the present disclosure can include: a step S100 of coating a surface of a breast implant mold structure including a first mold portion having a first volume, a second mold portion having a second volume smaller than the first volume, and a connecting mold portion connecting the first mold portion and the second mold portion; a step S200 of curing the coating liquid on the surface of the breast implant mold structure to form a first breast implant shell including a first shell corresponding to the first mold portion, a second shell corresponding to the second mold portion, and a hanging shell corresponding to the connecting mold portion; a step S300 of separating the breast implant mold structure from the first breast implant shell; and a step S400 of inserting the second shell and the hanging shell into an inner space of the first shell, thereby forming a second breast implant shell having a structure in which the second shell is hung by the hanging shell in the inner space of the first shell.

[0262] Hereinafter, each step of the manufacturing method S10 of a breast implant according to the present disclosure will be described in more detail.

[0263] Figure 17 A step S100 of coating a surface of a breast implant mold structure 10 according to an exemplary embodiment of the present disclosure is illustrated. Also, Figure 18 and Figure 19 to form a first breast implant shell including a first shell corresponding to the first mold portion, a second shell corresponding to the second mold portion, and a hanging shell corresponding to the connecting mold portion. Figure 17 An enlarged view of the connecting mold portion 130 of the breast implant mold structure 10, which is indicated by "A" in FIG. 1B.

[0264] Referring to Figure 17 In the step S100, the coating liquid CL can be coated on the surface of the breast implant mold structure 10 including the first mold portion 110, the second mold portion 120, and the connecting mold portion 130.

[0265] In an exemplary embodiment, before the step S100 is performed, the stem 15 can be coupled to a lower portion of the breast implant mold structure 10. Also, the step S100 can be a step of immersing the breast implant mold structure 10 in a water tank containing the coating liquid CL, thereby coating the coating liquid CL on the surface of the breast implant mold structure 10.

[0266] However, it is not limited thereto, and a more various coating method can be performed by spraying the coating liquid CL on the breast implant mold structure 10 to coat the surface of the breast implant mold structure 10, etc.

[0267] In an exemplary embodiment, the coating liquid CL described above can be a silicone solution. However, the coating liquid CL is not limited to a silicone solution and may contain many other types of solutions. For example, the coating liquid may contain flexible materials such as rubber. Furthermore, the material of the coating liquid may be a biocompatible organic compound or a polymer material.

[0268] In addition, the method S10 for manufacturing breast implants disclosed herein may include a step S100 of coating the surface of a breast implant mold structure 10, the mold structure 10 including a first mold portion 110 having a first volume, a second mold portion 120 having a second volume smaller than the first volume, and a connecting mold portion 130 connecting the first mold portion 110 and the second mold portion 120.

[0269] The breast implant mold structure 10 disclosed herein may include: a first mold portion 110 having a first volume, a second mold portion 120 having a second volume, and a connecting mold portion 130 connecting the first mold portion 110 and the second mold portion 120.

[0270] In an exemplary embodiment, the first mold portion 110 may be for forming the first housing SB1, which will be described below. Figure 20 The mold part 110 can be in the shape of a breast. However, it is not limited to this, and it can also be in the shape of a sphere or an ellipsoid.

[0271] In an exemplary embodiment, the second mold portion 120 may be for forming the second housing SB2, which will be described below. Figure 20 The volume of the second mold portion 120 can be smaller than the volume of the first mold portion 110. Therefore, the second housing SB2 can have a smaller volume than the first housing SB1, making it easier for the second housing SB2 to be inserted into the internal space of the first housing SB1 in step S400, which will be described below.

[0272] In an exemplary embodiment, the second mold portion 120 may be provided in a breast shape. However, it is not limited thereto; the second mold portion 120 may also be provided in a spherical or ellipsoidal shape.

[0273] In an exemplary embodiment, the second mold portion 120 may be provided such that the further away from the first mold portion 110 it is from its horizontal direction (i.e. Figure 17 The shape has a gradually decreasing lateral length. Therefore, when the second housing SB2, formed by the second mold portion 120, is inserted into the internal space of the first housing SB1, the second housing SB2 can be suspended by the first housing SB1 and hang naturally. Thus, the breast implant comprising the first housing SB1 and the second housing SB2 can achieve movements similar to those of a human breast.

[0274] In an exemplary embodiment, the second volume of the second mold part 120 can be provided to be about 25% to about 85% of the first volume of the first mold part 110. When the second volume of the second mold part 120 is less than 25% of the first volume of the first mold part 110, it will be difficult to secure the motility based on the external force or gravity caused by the body movement when the second shell SB2 formed through the second mold part 120 is inserted into the inner space of the first shell SB1 formed through the first mold part 110. In other words, when the second volume of the second mold part 120 is less than 25% of the first volume of the first mold part 110, the second shell SB2 cannot secure the motility in the inner space of the first shell SB1, and thus the breast implant including the above-described first shell SB1 and the above-described second shell SB2 cannot achieve the natural breast motility.

[0275] On the other hand, when the second volume of the second mold part 120 is greater than 85% of the first volume of the first mold part 110, it can be difficult to perform the step of inserting the second shell SB2 formed through the second mold part 120 into the inner space of the first shell SB1 formed through the first mold part 110.

[0276] In addition, when the second volume of the second mold part 120 is greater than 85% of the first volume of the first mold part 110, the second shell SB2 can secure excessive motility in the first shell SB1 due to the external force or gravity caused by the body movement, resulting in a collision between the above-described first shell SB1 and the second shell SB2 and physical damage. In addition, when the second volume of the second mold part 120 is greater than 85% of the first volume of the first mold part 110, the overall weight of the breast implant including the first shell SB1 and the second shell SB2 can be excessive, and thus it can be difficult for the suspension shell SH to safely support the second shell SB2.

[0277] That is, the second volume of the second mold part 120 of the present disclosure can be provided to be about 25% to about 85% of the first volume of the first mold part 110, so that when the second shell SB2 formed through the second mold part 120 is inserted into the first shell SB1 formed through the first mold part 110, the above-described second shell SB2 can secure relatively large motility under the external force or gravity caused by the body movement, and thus the breast implant including the first shell SB1 and the second shell SB2 can achieve the natural breast motility.

[0278] In addition, the second volume of the second mold part 120 of the present disclosure can be provided to be about 25% to about 85% of the first volume of the first mold part 110, and it is also possible to avoid physical damage caused by a collision between the first shell SB1 and the second shell SB2, and to make the overall weight of the breast implant including the first shell SB1 and the second shell SB2 relatively light.

[0279] Hereinafter, the connection mold part 130 of the present disclosure will be described in more detail with reference to the accompanying drawings. Figure 18 and Figure 19 The connection mold part 130 of the present disclosure can be provided in a structure in which the length thereof in the horizontal direction (i.e., the transverse direction) decreases as it moves away from the first mold part 110 and approaches the second mold part 120.

[0280] Referring to FIG. 1, Figure 18 , the connection mold part 130 of the present disclosure can have a structure in which the length thereof in the horizontal direction (i.e., the transverse direction) decreases as it moves away from the first mold part 110 and approaches the second mold part 120. Figure 18

[0281] As shown in FIG. 1, Figure 18 , the connection mold part 130 of the present disclosure can be provided in a structure in which the length thereof in the horizontal direction (i.e., the transverse direction) decreases as it moves away from the first mold part 110 and approaches the second mold part 120, so that the suspension housing SH formed by the above-described connection mold part 130 can be provided in a structure in which the length thereof in the horizontal direction decreases as it moves away from the surface of the first housing SB1 in the internal space of the first housing SB1. Accordingly, the second housing SB2 can be provided in a structure that is naturally suspended by the suspension housing SH in the internal space of the first housing SB1, and the above-described second housing SB2 has a large degree of movement due to the shape of the suspension housing SH, thereby achieving natural breast movement. Figure 20

[0282] In addition, the connection mold part 130 of the present disclosure can be provided in a structure in which the length thereof in the horizontal direction decreases as it moves away from the first mold part 110 and approaches the second mold part 120, so that when the breast implant mold structure 10 is erected in a manner in which the second mold part 120 faces upward and the coating liquid CL is coated on the breast implant mold structure 10, the above-described coating liquid CL can flow down along the inclined surface of the connection mold part 130 by the force of gravity and be uniformly coated on the entire surface of the breast implant mold structure 10.

[0283] In an exemplary embodiment, as shown in (a) of FIG. 2, Figure 18 , the cross section of the connection mold part 130a can be provided in a trapezoidal or triangular shape. Specifically, the connection mold part 130a can be provided in a tapered shape in which the length thereof in the horizontal direction (i.e., the transverse direction) decreases as it moves away from the first mold part 110 and approaches the second mold part 120.

[0284] In an exemplary embodiment, as shown in (b) of FIG. 2, Figure 18 ​​As shown in part (b) of FIG. 1, a cross-section of the connection mold portion 130b can be provided in a stepped shape having a step. Specifically, the connection mold portion 130b can include a first stepped region 1310b connected to the first mold portion 110 and having a first width in a horizontal direction (i.e., a lateral direction), and a second stepped region 1330b interposed between the first stepped region 1310b and the second mold portion 120 and having a second width smaller than the first width in the horizontal direction (i.e., the lateral direction).

[0285] In an exemplary embodiment, as shown in part (c) of FIG. 1, a cross-section of the connection mold portion 130c can be provided in a shape in which a length in a horizontal direction (i.e., a lateral direction) thereof decreases as it moves away from the first mold portion 110 and approaches the second mold portion 120, and an outer surface of the connection mold portion 130c can have a curved surface shape in a shape (e.g., a concave porcelain shape) that is recessed in a direction toward a central portion of the connection mold portion 130c. Figure 18

[0286] In an exemplary embodiment, as shown in part (d) of FIG. 1, a cross-section of the connection mold portion 130d can be provided in a shape in which a length in a horizontal direction (i.e., a lateral direction) thereof decreases as it moves away from the first mold portion 110 and approaches the second mold portion 120, and an outer surface of the connection mold portion 130c can have a curved surface shape in a shape (e.g., a convex porcelain shape) that is protruded in a direction toward an outer region of the connection mold portion. Figure 18

[0287] In an exemplary embodiment, a length of the connection mold portion 130d in a direction (i.e., a vertical direction or a longitudinal direction) away from the first mold portion 110 and approaching the second mold portion 120 can be about 0.2 cm to about 4.0 cm.

[0288] When the vertical length of the connection mold portion 130d is less than 0.2 cm, a suspension housing SH formed by the connection mold portion 130 can not provide sufficient mobility for a second housing SB2 in an inner space of a first housing SB1. Thus, the second housing SB2 can not secure mobility in the inner space of the first housing SB1, and thus a breast implant including the first housing SB1 and the second housing SB2 can not achieve natural breast movement.

[0289] In addition, when the vertical length of the connection mold portion 130d exceeds 4.0 cm, the second housing SB2 can be provided in an excessively sagging shape in the inner space of the first housing SB1 due to the suspension housing SH. Thus, the second housing SB2 and the first housing SB1 can collide, causing physical damage.

[0290] ​​The vertical length of the connection mold portion 130d of the present disclosure can be about 0.2 cm to about 4.0 cm, so that the second shell SB2 can secure greater mobility due to external force or gravity caused by body movement when the second shell SB2 is inserted into the inner space of the first shell SB1, thereby enabling the breast implant including the first shell SB1 and the second shell SB2 to achieve natural breast movement. In addition, physical damage caused by collision of the first shell SB1 and the second shell SB2 can be prevented, and the weight of the breast implant including the first shell SB1 and the second shell SB2 can be reduced.

[0291] Referring to Figure 19 , the connection mold portion 130 of the present disclosure can have a structure in which the length in the horizontal direction (i.e., the transverse direction) thereof increases as it moves away from the first mold portion 110 and approaches the second mold portion 120. Figure 19

[0292] As shown in Figure 19 , the connection mold portion 130 of the present disclosure can have a structure in which the length in the horizontal direction thereof increases as it moves away from the first mold portion 110 and approaches the second mold portion 120, so that when the breast implant mold structure 10 is flipped in such a manner that the second mold portion 120 faces downward (i.e., the first mold portion 110 faces upward) and the coating liquid CL is coated on the breast implant mold structure 10, the coating liquid CL can flow down along the inclined surface of the connection mold portion 130 under the action of gravity and be uniformly coated on the entire surface of the breast implant mold structure 10.

[0293] In an exemplary embodiment, as shown in Figure 19 part (a), the cross section of the connection mold portion 130e can be provided in the shape of an inverted trapezoid or an inverted triangle. Specifically, the connection mold portion 130e can be provided in the shape of a taper in which the length in the horizontal direction (i.e., the transverse direction) thereof increases as it moves away from the first mold portion 110 and approaches the second mold portion 120.

[0294] In an exemplary embodiment, as shown in Figure 19 part (b), the cross section of the connection mold portion 130f can be provided in the shape of a step having steps. Specifically, the connection mold portion 130f can include a first stepped region 1310f connected to the first mold portion 110 and having a first width in the horizontal direction (i.e., the transverse direction), and a second stepped region 1330f interposed between the first stepped region 1310f and the second mold portion 120 and having a second width greater than the first width in the horizontal direction (i.e., the transverse direction). However, it is not limited thereto, and the connection mold portion can further include two or more steps.

[0295] In an exemplary embodiment, as shown in​Figure 19 As shown in part (c), the cross section of the connecting mold portion 130g can be provided as a shape in which its length in the horizontal direction (i.e., laterally) increases as it moves away from the first mold portion 110 and closer to the second mold portion 120, and the outer surface of the connecting mold portion 130g can have a curved surface with a shape (e.g., a concave anti-ceramic shape) that is recessed toward the central portion of the connecting mold portion 130g.

[0296] In an exemplary embodiment, such as Figure 19 As shown in part (d), the cross section of the connecting mold portion 130h can be provided as a shape in which its length in the horizontal direction (i.e., laterally) increases as it moves away from the first mold portion 110 and closer to the second mold portion 120, and the outer surface of the connecting mold portion 130h can have a curved surface with a shape (e.g., a convex anti-ceramic shape) that protrudes toward the outer region of the connecting mold portion 130h.

[0297] In an exemplary embodiment, the length of the connecting mold portion 130d in the direction away from the first mold portion 110 and close to the second mold portion 120 (i.e., the vertical direction or longitudinal direction) can be from about 0.2 cm to about 4.0 cm.

[0298] Figure 20 A diagram illustrating step S200 of forming a first breast implant shell by curing a coating liquid on the surface of a breast implant mold structure according to an exemplary embodiment of the present disclosure.

[0299] In an exemplary embodiment, step S200 of this disclosure may be step S200 of forming a first breast implant housing S1, which includes a first housing SB1 corresponding to a first mold portion 110, a second housing SB2 corresponding to a second mold portion 120, and a suspension housing SH corresponding to a connecting mold portion 130, by curing a coating liquid CL onto the surface of the breast implant mold structure 10.

[0300] In an exemplary embodiment, in step S200, the coating liquid CL applied to the surface of the breast implant mold structure 10 of this disclosure can be allowed to cure naturally or by using a drying device to adhere to the breast implant mold structure 10. This results in the formation of a first breast implant housing S1 comprising a first housing SB1 corresponding to the first mold portion 110, a second housing SB2 corresponding to the second mold portion 120, and a suspension housing SH corresponding to the connecting mold portion 130.

[0301] Figure 21 To illustrate step S300 of separating the breast implant mold structure 10 from the first breast implant housing S1 according to an exemplary embodiment of the present disclosure.

[0302] Referring to Figure 21 In step S300, the rod 15 combined with the breast implant mold structure 10 can be removed. Thereafter, the opening formed at the connection portion of the breast implant mold structure 10 and the rod 15 is opened, and the first breast implant shell S1 can be flipped and separated from the breast implant mold structure 10.

[0303] As the breast implant mold structure 10 is separated from the first breast implant shell S1, the first breast implant shell S1 of the present disclosure can have a structure including a first shell SB1 having a first inner space, a second shell SB2 having a second inner space, and a hanging shell SH connecting the first shell SB1 and the second shell SB2.

[0304] Figure 22 To illustrate step S400 of inserting the second shell SB2 and the hanging shell SH into the inner space of the first shell SB1 to form a second breast implant shell S2 according to an exemplary embodiment of the present disclosure.

[0305] Referring to Figure 22 In step S400, a step of inserting the second shell SB2 and the hanging shell SH into the inner space of the first shell SB1 can be performed. For example, the insertion of the second shell SB2 and the hanging shell SH in step S400 can be performed by the action of a machine (e.g., a pusher) that applies an external force to the second shell SB2 and the hanging shell SH in the direction of the inner space of the first shell SB1. However, the method of inserting the second shell SB2 and the hanging shell SH into the inner space of the first shell SB1 is not limited to the above.

[0306] That is, by performing step S400, the second shell SB2 and the hanging shell SH can be disposed in the inner space of the first shell SB1, and thus the breast implant of the present disclosure can form a second breast implant shell S2 structure including a plurality of shells.

[0307] In an exemplary embodiment, as the second shell SB2 and the hanging shell SH are inserted into the inner space of the first shell SB1, the outer surface of the second shell SB2 and the outer surface of the hanging shell SH of the first breast implant shell S1 as shown in FIG. 4A can form the inner surface of the second shell SB2 and the inner surface of the hanging shell SH of the second breast implant shell S2 as shown in FIG. 4B, respectively. Figure 21 Figure 22

[0308] ​​Further, in the exemplary embodiment, since the rod 15 is removed in the above-described step S300, a first opening SB1_H can be formed in a lower portion of the second breast implant shell S2. Further, as the second shell SB2 and the hanging shell SH are inserted into the inner space of the first shell SB1 in step S400, a second opening SH_H can be formed in an upper portion of the second breast implant shell S2.

[0309] The manufacturing method S10 of a breast implant according to the exemplary embodiment of the present disclosure can perform the above-described steps S100 to S400, and thus the manufacturing method S10 of a breast implant of the present disclosure can manufacture a breast implant including a plurality of shells. Thereby, the breast implant manufactured by the manufacturing method of the present disclosure can similarly realize the shape and the tactile sensation of a real breast composed of mammary tissue and adipose tissue, and can realize natural breast movement.

[0310] Figure 23 A flowchart illustrating a flow of the manufacturing method S20 of a breast implant according to the exemplary embodiment of the present disclosure.

[0311] The manufacturing method S20 of a breast implant of the present disclosure can be performed after the manufacturing method S10 of a breast implant described with reference to Figures 16 to 22 The manufacturing method S20 of a breast implant of the present disclosure can be performed after the manufacturing method S10 of a breast implant described with reference to Figures 16 to 22 The manufacturing method S20 of a breast implant of the present disclosure can be performed after the manufacturing method S10 of a breast implant described with reference to

[0312] The manufacturing method S20 of a breast implant of the present disclosure can further include a step S500 of closing the first opening SB1_H of the first shell SB1 and the second opening SH_H of the hanging shell SH by attaching the patches 310, 330, and a step S600 of injecting a first filler into the first shell SB1 and a second filler into the second shell SB2 and the hanging shell SH. The steps S500 and S600 of the present disclosure can be performed after the step S400 described with reference to Figure 16 The manufacturing method S20 of a breast implant of the present disclosure can be performed after the manufacturing method S10 of a breast implant described with reference to

[0313] Hereinafter, the manufacturing method S20 of a breast implant of the present disclosure will be described in detail with reference to Figure 24 and Figure 25 The manufacturing method S20 of a breast implant of the present disclosure can be performed after the manufacturing method S10 of a breast implant described with reference to

[0314] Figure 24 A diagram illustrating the step S500 of closing the first opening SB1_H of the first shell SB1 and the second opening SH_H of the hanging shell SH by attaching the patches 310, 330 of the present disclosure.

[0315] The manufacturing method S20 of a breast implant of the present disclosure can be performed after the manufacturing method S10 of a breast implant described with reference to Figure 24In step S500, the first patch 310 can be attached to the first opening SB1_H of the first case SB1 to seal the first opening SB1_H. In an exemplary embodiment, after the first patch 310 is inserted into the first opening SB1_H, the first patch 310 is attached to the inner surface of the first case SB1 adjacent to the first opening SB1_H to seal the first opening SB1_H.

[0316] In addition, in step S500, the second patch 330 can be attached to the second opening SH_H of the hanging case SH to seal the second opening SH_H. In an exemplary embodiment, after the second patch 330 is inserted into the second opening SH_H, the second patch 330 is attached to the inner surface of the hanging case SH adjacent to the second opening SH_H to seal the second opening SH_H.

[0317] In addition, the first patch 310 and the second patch 330 can have substantially the same elasticity and physical properties as the first case SB1, the second case SB2, and the hanging case SH. In an exemplary embodiment, the material of the first patch 310 and the second patch 330 can include the same material as the first case SB1, the second case SB2, and the hanging case SH. For example, the material of the first patch 310 and the second patch 330 can include silicone.

[0318] Figure 25 A diagram to illustrate step S600 of injecting the first filler FM1 into the first case SB1 and injecting the second filler FM2 into the second case SB2 and the hanging case SH according to the present disclosure.

[0319] Referring to Figure 25 In step S600, the first filler FM1 can be injected into the inner space of the first case SB1 by injection, and the second filler FM2 can be injected into the inner space of the second case SB2 and the hanging case SH by injection.

[0320] In an exemplary embodiment, the first filler FM1 and the second filler FM2 can include saline, silicone gel, and hydro-gel. However, the types of the first filler FM1 and the second filler FM2 are not limited to the above.

[0321] In an exemplary embodiment, in step S600, a syringe needle can be inserted into the first patch 310 so that the first filler FM1 is injected into the inner space of the first case SB1. In addition, in step S600, a syringe needle can be inserted into the second patch 330 so that the second filler FM2 is injected into the inner space of the second case SB2.

[0322] At this time, the first filler FM1 can have a first density. The density of the first filler FM1 can be defined as a mass per unit volume of the first filler FM1. For example, when the first filler FM1 includes a first silica gel, the density of the first silica gel can be defined as the first density.

[0323] In an exemplary embodiment, the first density of the first filler FM1 for filling the first housing SB1 can be less than the second density of the second filler FM2 for filling the second housing SB2.

[0324] Further, the first filler FM1 can have a first viscosity. The viscosity of the first filler FM1 can be defined as a thick and sticky property of the first filler FM1, and the viscosity of the first filler FM1 can be defined as a degree of stickiness of the first filler FM1. For example, a greater viscosity indicates a higher resistance to the flow of a fluid, and a smaller viscosity indicates a lower resistance to the flow of a fluid.

[0325] In an exemplary embodiment, the first viscosity of the first filler FM1 for filling the first housing SB1 can be less than the second viscosity of the second filler FM2 for filling the second housing SB2.

[0326] For example, the viscosity coefficient of the first filler FM1 can be defined as a numerical value of the viscosity of a liquid. For example, the first viscosity coefficient of the first filler FM1 can be less than the second viscosity coefficient of the second filler FM2 for filling the second housing SB2.

[0327] Further, the first filler FM1 for filling the first housing SB1 can have a first cohesive force. The cohesive force of the first filler FM1 can be defined as an attractive force between molecules constituting the first filler FM1. For example, when the first filler FM1 includes a first silica gel, the cohesive force of the first silica gel can be defined as the first cohesive force.

[0328] In an exemplary embodiment, the first cohesive force of the first filler FM1 can be less than the second cohesive force of the second filler FM2 for filling the second housing SB2.

[0329] The breast of a human body is composed of mammary gland tissue and fat tissue surrounding the mammary gland tissue, and thus, when a person is in a supine state, the breast tends to expand in a horizontal direction perpendicular to the direction of gravity due to the action of gravity, and when the person is in a standing state, the breast tends to sag in a vertical direction parallel to the direction of gravity due to the action of gravity.

[0330] The breast implant manufactured by the breast implant manufacturing method S20 of the present disclosure can include a plurality of shells, wherein the filler filled in the inner shell can have greater density, viscosity, and cohesion than the filler filled in the outer shell, and thus the breast implant manufactured by the breast implant manufacturing method of the present disclosure can achieve a similar motion to a human breast.

[0331] In addition, the breast implant manufactured by the breast implant manufacturing method S20 of the present disclosure can include a plurality of shells, wherein the filler filled in the inner shell can have greater density, viscosity, and cohesion than the filler filled in the outer shell, and thus the breast implant manufactured by the breast implant manufacturing method of the present disclosure can achieve a similar motion to a human breast.

[0332] In an exemplary embodiment, the first filler FM1 filled in the first shell SB1 can be normal saline, and the second filler FM2 filled in the second shell SB2 can be silicone. The breast implant manufactured by the breast implant manufacturing method of the present disclosure can include the plurality of shells described above, and the outermost shell among the plurality of shells can contain normal saline as the filler, thereby reducing the size of a patient's incision scar and improving cosmetic satisfaction when the breast implant is implanted in the human body.

[0333] In an exemplary embodiment, the first filler FM1 filled in the first shell SB1 can be water, and the second filler FM2 filled in the second shell SB2 can be silicone having a greater density than water. For example, the density of the silicone can be about 1.01 g / ml to about 1.20 g / ml and can have a value greater than the density of water. Thus, the breast implant manufactured by the breast implant manufacturing method of the present disclosure includes a plurality of shells, and the outermost shell among the plurality of shells can contain water having a density less than silicone as the filler, thereby reducing the size of a patient's incision scar and improving cosmetic satisfaction when the breast implant is implanted in the human body.

[0334] In addition, in the past, in order to confirm whether the breast implant is ruptured, it was necessary to make a judgment by precise ultrasonic wave or nuclear magnetic resonance examination. Thus, the removal or replacement time of the breast implant was delayed, or various complications including capsular contracture were caused due to increased inflammatory reactions. However, the breast implant manufactured by the breast implant manufacturing method of the present disclosure can contain normal saline in the outer shell forming the appearance, and thus even if the outer shell is damaged due to external impact and the filler leaks, rupture can be immediately perceived by the reduction in the volume of the implant, and the normal saline can be safely absorbed by the human body. Thus, the patient can immediately plan the removal and replacement surgery of the breast implant, and the frequency of capsular contracture and inflammatory reactions caused by maintaining the ruptured state for a long time can be reduced. In other words, the psychological stress of the patient on the rupture of the breast implant can be reduced.

[0335] Figure 26 FIG. 1 is a diagram showing a flow of a manufacturing method S30 of a breast implant according to an exemplary embodiment of the present disclosure.

[0336] Referring to Figure 26 , the manufacturing method S30 of the breast implant of the present disclosure can include a step S100 of coating a surface of a breast implant mold structure including a first mold portion having a first volume, a second mold portion having a second volume smaller than the first volume, and a connecting mold portion connecting the first mold portion and the second mold portion; a step S150 of adjusting a thickness of a coating liquid on the breast implant mold structure by rotating the breast implant mold structure; a step S200 of solidifying the coating liquid of the surface of the breast implant mold structure to form a first breast implant shell including a first shell corresponding to the first mold portion, a second shell corresponding to the second mold portion, and a hanging shell corresponding to the connecting mold portion; a step S300 of separating the breast implant mold structure from the first breast implant shell; a step S350 of inspecting a leakage of the first breast implant shell by injecting a test liquid into the first breast implant shell; a step S400 of inserting the second shell and the hanging shell into an inner space of the first shell to form a second breast implant shell having a structure in which the second shell is hung in the inner space of the first shell by the hanging shell; a step S500 of closing openings of the first shell and the hanging shell by joining a patch; and a step S600 of injecting a first filler into the first shell and injecting a second filler into the second shell and the hanging shell to form the breast implant.

[0337] Hereinafter, the contents of the manufacturing methods S10, S20 of the breast implant of the present disclosure described with reference to Figures 16 to 25 will be omitted, and only the differences will be mainly described.

[0338] The manufacturing method S30 of the breast implant of the present disclosure can further include the step S150 of adjusting the thickness of the coating liquid on the breast implant mold structure by rotating the breast implant mold structure.

[0339] When the thickness of each portion of the breast implant is uniformly formed, in the case where the breast implant is implanted into a human body, a portion of the breast implant can be folded due to the filler being biased downward, resulting in a water-ripple phenomenon (rippling). When the above water-ripple phenomenon repeatedly occurs at a specific portion, the physical properties of the portion can be weakened, thereby there is a risk of rupture of the breast implant.

[0340] To solve this problem, the manufacturing method S30 of the breast implant of the present disclosure can further include a step S150 of rotating the breast implant mold structure 10 coated with the coating liquid CL. By performing the step S150, the side portion of the first breast implant shell S1 can be reinforced.

[0341] In exemplary embodiments, in the step S150, the rotation can be performed such that the apex end of the breast implant mold structure 10 is directed upward. Also, in the step S150, the rotation can be performed such that the apex end of the breast implant mold structure 10 is directed downward. For example, the step S150 can be implemented by alternately performing a step of rotating the breast implant mold structure 10 with the apex end directed upward and a step of rotating the breast implant mold structure 10 with the apex end directed downward.

[0342] Specifically, when the breast implant mold structure 10 is rotated with the apex end directed upward, the coating liquid CL flows toward the side portion of the breast implant mold structure 10 under the action of gravity and centrifugal force, and thus the thickness of the apex end adjacent portion of the first breast implant shell S1 can be formed relatively thin. In contrast, when the breast implant mold structure 10 is rotated with the apex end directed downward, the coating liquid CL flows toward the apex end of the breast implant mold structure 10 under the action of gravity, and thus the thickness of the apex end adjacent portion can be formed relatively thick.

[0343] Thus, by alternately performing the step of rotating the breast implant mold structure 10 with the apex end directed upward and the step of rotating the breast implant mold structure 10 with the apex end directed downward, the method of the present disclosure can easily adjust the thickness of the first breast implant shell S1.

[0344] By performing the step S150, the thickness of a portion in which the corrugation phenomenon frequently occurs can be controlled, and thus the folding resistance and durability of the portion can be ultimately improved.

[0345] The manufacturing method S30 of the breast implant of the present disclosure can include a step S350 of checking a leak of the first breast implant shell S1 by injecting a test liquid into the first breast implant shell. The test liquid can include water, but the kind of the test liquid is not limited to the above.

[0346] In exemplary embodiments, in the step S350, the test liquid can be injected into the first breast implant shell S1 separated from the breast implant mold structure 10. For example, in the step S350, a test liquid having a volume greater than the volume of the first breast implant shell S1 can be injected into the inner space of the first breast implant shell S1, and thus the first breast implant shell S1 can be inflated.

[0347] At this time, when the test liquid is injected into the first breast implant shell S1, and the volume of the first breast implant shell S1 is greater than its original volume due to the elasticity of the first breast implant shell S1 itself, it can be determined that the first breast implant shell S1 has no leakage.

[0348] On the contrary, when the test liquid is injected into the first breast implant shell S1 and the volume of the first breast implant shell S1 does not increase compared to its original size, or the test liquid is discharged from a part of the first breast implant shell S1, it can be determined that the first breast implant shell S1 has a leakage.

[0349] Figure 27 To show the step of coating the surface of the breast implant mold structure 10a according to the exemplary embodiment of the present disclosure.

[0350] Referring to Figure 27 , the breast implant mold structure 10a can include a first mold portion 110a, a second mold portion 120a, and a connecting mold portion 130.

[0351] In the exemplary embodiment, the second mold portion 120a can include a plurality of shell pockets 1210a to 1260a. As Figure 27 shown, the plurality of shell pockets 1210a to 1260a can be formed to protrude outward from the center portion, thereby constituting a bundle-like structure. For example, each of the plurality of shell pockets 1210a to 1260a protrudes outward from the center portion, and thus the second mold portion 120a can be provided in the shape of a breast tissue or a palm.

[0352] Further, in the exemplary embodiment, the plurality of shell pockets can include a rod-shaped shell and an elliptical shell extending from the rod-shaped shell and having a volume (or width) greater than that of the rod-shaped shell. Thereby, the breast implant made by the breast implant mold structure of the present disclosure can more realistically reproduce the structure of the breast tissue.

[0353] Further, in the exemplary embodiment, the plurality of shell pockets can have a structure in which a plurality of through-holes are formed through the plurality of shell pockets. That is, when the plurality of shell pockets are viewed from a planar perspective, the plurality of shell pockets can have a plurality of holes formed through the surface. Thereby, the breast implant made by the breast implant mold structure of the present disclosure can reduce the weight due to the plurality of shell pockets having the through-holes.

[0354] In an exemplary embodiment, when the second case STa corresponding to the second mold part 120a is inserted into the inner space of the first case SB1a, the shape of the above-mentioned second case STa can be similar to the shape of breast tissue. Thus, when the above-mentioned second case STa is filled with the second filler FM2a, the breast implant BIa including the first case SB1a and the second case STa can be provided in a shape similar to a human breast to enable a similar feeling and movement to a human breast.

[0355] Figure 28 A diagram to illustrate a method of manufacturing a breast implant BIb using the breast implant mold structure 10b according to an exemplary embodiment of the present disclosure.

[0356] Hereinafter, a description will be given mainly of the differences, with the contents repeated with the breast implant mold structure 10 of Figure 16

[0357] Referring to Figure 28 , the breast implant mold structure 10b of the present disclosure can include a first mold part 110b, a second mold part 120b, a first connecting mold part 130, a third mold part 140b, and a second connecting mold part 150.

[0358] At this time, the first connecting mold part 130 can be a part of the breast implant mold structure 10b connecting the first mold part 110b and the second mold part 120b. Also, the second connecting mold part 150 can be a part of the breast implant mold structure 10b connecting the second mold part 120b and the third mold part 140b.

[0359] In an exemplary embodiment, a first volume of the first mold part 110b can be greater than a second volume of the second mold part 120b. Also, the second volume of the second mold part 120b can be greater than a third volume of the third mold part 140b.

[0360] Thus, a volume of a first case SB1b corresponding to the first mold part 110b can be greater than a volume of a second case SB2b corresponding to the second mold part 120b. Also, the volume of the second case SB2b corresponding to the second mold part 120b can be greater than a volume of a third case SB3b corresponding to the third mold part 140b.

[0361] In an exemplary embodiment, the second case SB2b can be accommodated in the inner space of the first case SB1b, and the above-mentioned second case SB2b can be suspended within the above-mentioned first case SB1b by a first suspension case SH1b. Also, the third case SB3b can be accommodated in the inner space of the second case SB2b, and the above-mentioned third case SB3b can be suspended within the above-mentioned second case SB2b by a second suspension case SH2b.​

[0362] In an exemplary embodiment, as the third shell SB3b is inserted inside the second shell SB2b, and the second shell SB2b is inserted inside the first shell SB1b, the second breast implant shell S2b of the present disclosure can be manufactured.

[0363] At this time, the second breast implant shell S2b can include a first opening SB1b_H formed on the first shell SB1b by removing the stem, a second opening SH1b_H formed by inserting the second shell SB2b and the first hanging shell SH1b inside the first shell SB1b, and a third opening SH2b_H formed by inserting the third shell SB3b and the second hanging shell SH2b inside the second shell SB2b.

[0364] For example, the first opening SB1b_H and the third opening SH2b_H can be provided at a lower portion of the second breast implant shell S2b, and the second opening SH1b_H can be provided at an upper portion of the second breast implant shell S2b.

[0365] In an exemplary embodiment, the first opening SB1b_H, the second opening SH1b_H, and the third opening SH2b_H can be closed by the first patch 310b, the second patch 330b, and the third patch 350b, respectively. Since the technical idea of closing the openings by the patches is repeated with the above, a detailed description is omitted.

[0366] In an exemplary embodiment, before the first opening SB1b_H is closed by the first patch 310b, the third opening SH2b_H can be closed by the third patch 350b first. That is, after the third opening SH2b_H is closed by the third patch 350b, the first opening SB1b_H can be closed by the first patch 310b again.

[0367] After that, the filler can be injected into the inside of the first shell SB1b, the second shell SB2b, and the third shell SB3b. Since the technical idea of injecting the filler into the plurality of shells is repeated with the above, a detailed description is omitted.

[0368] The breast implant BIb manufactured by the manufacturing method of the breast implant of the present disclosure can include a plurality of shells, in which the filler filled in the inner shell can have greater density, viscosity, and cohesion than the filler filled in the outer shell, and thus the breast implant manufactured by the manufacturing method of the breast implant of the present disclosure can achieve a similar movement to a human breast.

[0369] Furthermore, the breast implant manufactured by the method of manufacturing the breast implant disclosed herein may include multiple shells, wherein the filler filling the inner shell may have a greater density, viscosity and cohesive force than the filler filling the outer shell. Therefore, the breast implant manufactured by the method of manufacturing the breast implant disclosed herein can achieve a tactile feel similar to that of a human breast.

[0370] Figure 29 Figures are provided for a breast implant according to a comparative example and a breast implant according to this disclosure.

[0371] also, Figure 30 The diagram illustrates the shapes of the breast implants according to the comparative examples and the breast implants of this disclosure when arranged on a plane. Figure 31 A diagram illustrating the shape of a breast implant according to a comparative example and a breast implant of the present disclosure arranged in a vertical plane.

[0372] Reference Figure 29 The breast implant M1 disclosed herein may be a breast implant comprising a first shell (outer shell) and a second shell (inner shell). Technical concepts and references regarding the breast implant and its manufacturing method disclosed herein. Figures 16 to 28 The content is repeated, so detailed descriptions are omitted. Furthermore, the breast implant M2 according to the comparative example may be a breast implant consisting of a single shell.

[0373] In one embodiment, the first elastic modulus of the first housing may be less than the second elastic modulus of the second housing. Elastic modulus represents the degree of resistance of a material to tensile or compressive forces. For example, the elastic modulus of silicone may be from 3 MPa to 15 MPa.

[0374] In one embodiment, the first elastic modulus of the first filler used in the first housing (outer shell) may be less than the second elastic modulus of the second filler used in the second housing (inner shell). For example, the first elastic modulus of the first housing may be about 1 MPa to 7 MPa, while the second elastic modulus of the second housing may be 8 MPa to 17 MPa.

[0375] Reference Figure 29 The outer shell of the breast implant M1 disclosed herein may have a first elastic modulus of 5 MPa, and the inner shell may have a second elastic modulus of 15 MPa. Furthermore, as... Figure 29 The breast implant M2 shown according to the comparative example can be a single-shell breast implant with an elastic modulus of 10 MPa.

[0376] In reference Figure 30 and Figure 31 Before proceeding with the explanation, for Figure 30 and Figure 31The horizontal length (i.e., width) of the breast implant of the present disclosure and the breast implant according to the comparative example for simulation can be about 12 cm. In addition, the vertical length (i.e., height) of the breast implant of the present disclosure and the breast implant according to the comparative example for simulation can be about 4 cm. Also, the horizontal length of the second shell (i.e., inner shell) of the breast implant of the present disclosure can be about 6 cm, and the vertical length can be about 3 cm.

[0377] Referring to Figure 30 When the breast implant of the present disclosure composed of a plurality of shells and the breast implant according to the comparative example composed of a single shell are arranged on a horizontal plane (i.e., floor surface), the breast implant according to the present disclosure generates a displacement of 5.68 x 10-4 mm, and the comparative example breast implant generates a displacement of 4.77 x 10-4 mm.

[0378] That is, the deformation ratio with respect to the height of the breast implant of the present disclosure is greater than that of the breast implant according to the comparative example. Thus, the width change (i.e., horizontal length change) of the breast implant of the present disclosure can be greater than that of the breast implant according to the comparative example.

[0379] Therefore, the breast implant of the present disclosure can more realistically reproduce the movement of the breast when the human body is in a supine state, compared to the breast implant according to the comparative example.

[0380] In other words, the breast implant manufactured by the manufacturing method of the breast implant of the present disclosure includes a plurality of shells, and the filler filled in the inner shell can have a higher elastic modulus than the filler filled in the outer shell, and thus the breast implant manufactured by the manufacturing method of the breast implant of the present disclosure can achieve a movement similar to the movement of the breast when the human body is in a supine state.

[0381] Referring to Figure 31 When the breast implant of the present disclosure composed of a plurality of shells and the breast implant according to the comparative example composed of a single shell are arranged on a vertical plane, the breast implant of the present disclosure generates a displacement of 3.43 x 10-4 mm in the direction of gravity, and the breast implant according to the comparative example generates a displacement of 2.17 x 10-4 mm. That is, the breast implant of the present disclosure can achieve a greater sagging deformation under the action of gravity.

[0382] In addition, when the breast implant of the present disclosure composed of a plurality of shells and the breast implant according to the comparative example composed of a single shell are arranged on a vertical plane, as shown in Figure 31 , the breast implant of the present disclosure can achieve a shape similar to the shape of the breast sagging under the action of gravity.

[0383] That is, the breast implant manufactured by the manufacturing method of the breast implant of the disclosure includes a plurality of shells, and the filler filled in the inner shell can have a higher modulus of elasticity than the filler filled in the outer shell, so the breast implant manufactured by the manufacturing method of the breast implant of the disclosure can achieve a movement similar to the breast movement in the standing state of the human body.

[0384] Exemplary embodiments are disclosed in the drawings and specification herein. Although specific terms are employed in the specification and drawings, such terms are used in a generic and descriptive sense only and not for purposes of limitation of the scope of the disclosure herein. Accordingly, it will be understood that without the use of such specific terms or otherwise, embodiments in accordance with the disclosure could be had by appropriately applying the principles disclosed herein to other embodiments and applications. Therefore, the true scope of the present disclosure is not to be limited to the specific embodiments disclosed herein but is to be accorded the full scope of the appended claims, together with full equivalents thereof to which they properly enjoy.

Claims

1. A breast implant, characterized in that, include: A first housing that contains a first filler in its internal space; The second housing surrounds the first housing and accommodates the second filler in the internal space; A third housing surrounds the second housing and accommodates a third filler within the internal space; as well as The injection port provides spaces for injecting the first filler, the second filler, and the third filler into the first housing, the second housing, and the third housing, respectively.

2. The breast implant according to claim 1, characterized in that, The density of the first filler is greater than the density of the second filler. The density of the second filler is greater than the density of the third filler.

3. The breast implant according to claim 1, characterized in that, The viscosity of the first filler is greater than the viscosity of the second filler. The viscosity of the second filler is greater than that of the third filler.

4. The breast implant according to claim 1, characterized in that, The cohesive force of the first filler is greater than that of the second filler. The cohesive force of the second filler is greater than that of the third filler.

5. The breast implant according to claim 2, characterized in that, The first filler mentioned above is a first silicone gel. The second filler is a type of silicone with a density lower than that of the first silicone. The third filler is a third silicone with a density lower than that of the second silicone.

6. The breast implant according to claim 2, characterized in that, The first filler mentioned above is a first silicone gel. The second filler is a type of silicone with a density lower than that of the first silicone. The third filler is physiological saline with a density lower than that of the second silica gel.

7. The breast implant according to claim 1, characterized in that, The injection port is located at the junction of the first housing, the second housing, and the third housing.

8. The breast implant according to claim 7, characterized in that, The above-mentioned injection ports include: The first injection port provides a space for the first housing to be injected with the first filler. A second injection port surrounds the first injection port and provides space for injecting the second filler into the second housing; and The third injection port surrounds the second injection port and provides space for injecting the third filler into the third housing.

9. The breast implant according to claim 1, characterized in that, The injection port mentioned above corresponds to the areola area of ​​the human body.

10. The breast implant according to claim 1, characterized in that, The aforementioned breast implant also includes a sealing component for sealing the injection port.

11. The breast implant according to claim 1, characterized in that, The aforementioned first housing includes: A first filling portion, which contains the aforementioned first filling material; and The first suspension portion is connected to the first filling portion and the first filling portion is suspended inside the second housing. The aforementioned second housing includes: The second filling portion, which contains the aforementioned second filling material; and The second suspension portion is connected to the second filling portion and the second filling portion is suspended inside the third housing.

12. A breast implant, characterized in that, include: A first housing that contains a first filler in its internal space; The second housing surrounds the first housing and accommodates the second filler in the internal space; as well as The injection port provides spaces for injecting the first filler and the second filler into the first housing and the second housing, respectively. The density of the first filler is greater than the density of the second filler.

13. The breast implant according to claim 12, characterized in that, The first filler mentioned above is silicone with a first density. The second filler is silicone with a second density that is less than the first density.

14. The breast implant according to claim 12, characterized in that, The first filler mentioned above is silicone with a first density. The second filler is physiological saline with a density lower than that of the first filler.

15. The breast implant according to claim 12, characterized in that, The viscosity of the first filler is greater than that of the second filler.

16. The breast implant according to claim 12, characterized in that, The cohesive force of the first filler is greater than that of the second filler.

17. The breast implant according to claim 12, characterized in that, The aforementioned injection port corresponds to the areola area of ​​the human body. The above-mentioned injection ports include: A first injection port provides space for the first housing to be injected with the first filler; and The second injection port surrounds the first injection port and provides space for the second housing to inject the second filler.

18. The breast implant according to claim 12, characterized in that, The aforementioned first housing includes: A first filling portion, which contains the aforementioned first filling material; and The first suspension portion is connected to the first filling portion and the first filling portion is suspended inside the second housing. When the breast implant is arranged on the bottom surface with the injection port facing upward, the cross-sectional area of ​​the first suspension portion in the horizontal direction is smaller than the cross-sectional area of ​​the first filling portion in the horizontal direction.

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