KR102312054B1 - A silicone oil leakage preventive silicone gel-filled breast prosthesis - Google Patents

Abstract

One aspect of the present invention is a silicone shell; and an inner layer laminated inside the silicone shell, wherein the inner layer includes a porous metal-organic skeleton.

Description

Silicone gel breast implant with silicone oil leak prevention function

The present invention relates to a silicone gel breast implant, and more particularly, to a silicone gel breast implant having a leak detection function by introducing a filler including a metal-organic skeleton.

Silicone gel-filled breast prosthesis is widely used for cosmetic purposes to correct the shape or enlarge the size of specific parts of the body, such as the nose, breast, or buttocks, and organs or tissues damaged by disease or accident. It is also used as a replacement for

In general, silicone gel breast implants are in the form of filling a silicone shell with excellent biocompatibility.

Among them, silicone gel-filled implants are the most widely used in the market because of their excellent durability and tactile feel. However, the low molecular weight silicone oil contained in the silicone gel may cause swelling of the shell, and repeated swelling may reduce the durability and elasticity of the silicone gel breast implant and cause leakage of the silicone gel. have.

The leaked silicone gel can adversely affect tissues or organs in the body, resulting in tissue necrosis, bacterial infection, spheroid contracture, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), and breast implant rupture. rupture), or cause a change in the volume or shape of the silicone gel breast implant, causing the patient to undergo additional treatment.

In order to solve the above problem, a barrier layer to prevent gel leakage or a silicone gel having high cohesive strength has been developed, but it has not been a fundamental solution to silicone oil leakage.

When the silicone oil leaks, inflammation or spherical contracture may occur in vivo. Therefore, there is a demand for the development of a silicone gel breast implant capable of preventing the leakage of the silicone oil and delaying or blocking the possibility of the leakage of the silicone oil in vivo.

The present invention is to solve the problems of the prior art described above, and an object of the present invention is to prevent leakage of silicone oil by stacking an inner layer including a metal-organic framework (MOF) on a silicone shell, and To provide a silicone gel breast implant that minimizes inflammation and spherical contracture caused by oil leakage.

One aspect of the present invention is a silicone shell; and an inner layer laminated inside the silicone shell, wherein the inner layer includes a porous metal-organic skeleton.

In one embodiment, the inner layer may be laminated on one surface or the entire surface inside the silicon shell.

In one embodiment, the thickness of the inner layer may be 5 ~ 100㎛.

In one embodiment, the metal of the metal-organic framework may be one selected from the group consisting of alkali metals, alkaline earth metals, transition metals, post-transition metals, metalloids, and combinations of two or more thereof.

In one embodiment, the metal-organic framework comprises MIL-101, MIL-88A, MIL-88Bt, MIL-100, MIL-53, MOF-74, UiO-66, UiO-67, ZIF-8, ZIFs, It may be one selected from the group consisting of HKUST-1, M2 (dobpdc), NU-1000, PCN-222, PCN-224, derivatives thereof, and combinations of two or more thereof.

In one embodiment, the content of the metal-organic skeleton may be 5 to 20% by weight based on the total weight of the inner layer.

In an embodiment, the average particle diameter of the metal-organic framework may be 1 to 100 nm.

In one embodiment, the average diameter of the pores of the metal-organic framework may be 0.1 ~ 4.0 nm.

In an embodiment, the surface area of the metal-organic framework may be ^{500 to 5,000 m 2} g ^{-1 .}

In an embodiment, the cross-sectional shape of the silicone gel breast implant may be one selected from a circle, an oval, and a teardrop.

The silicone gel breast implant according to one aspect of the present invention prevents leakage of silicone oil by laminating an inner layer including a metal-organic framework (MOF) on a silicone shell, and inflammation and spherical construction caused by silicone oil leakage phenomenon can be minimized.

It should be understood that the effects of the present invention are not limited to the above-described effects, and include all effects that can be inferred from the configuration of the invention described in the detailed description or claims of the present invention.

1 is a cross-sectional view of a silicone gel breast implant in which an inner layer is laminated on one surface of a silicone shell according to an embodiment of the present invention.
FIG. 2 is an enlarged view of part A of FIG. 1 .
3 is a cross-sectional view of a silicone gel breast implant in which an inner layer is laminated on the front surface of a silicone shell according to an embodiment of the present invention.

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

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

As used herein, the term "metal-organic framework (MOF)" refers to a unit in which a metal ion or a metal ion cluster is coordinated with an organic ligand or an organic linker, which is regular or irregular. It is an organic-inorganic hybrid material that is arranged and formed. In this case, the metal-organic framework may be formed in a one-dimensional, two-dimensional, or three-dimensional structure.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

silicone gel breast implants

1 and 3 are cross-sectional views of a silicone gel breast implant in which an inner layer stacked on the inside of a silicone shell according to an embodiment of the present invention is stacked on one side and the front side, respectively.

Referring to FIG. 1 , a silicone gel breast implant 100 according to an aspect of the present invention includes a silicone shell 11 ; and an inner layer 12 stacked inside the silicon shell 11, wherein the inner layer 12 may include a porous metal-organic skeleton.

In the silicone gel breast implant 100 according to the present invention, the inner layer 12 may be laminated on one side or the entire surface of the inside of the silicone shell 11 . The inner layer 12 is one surface inside the silicone shell 11, preferably with reference to FIG. 1, is laminated on the inner side of the lower surface of the silicone gel breast implant, or may be located on the outer surface of the lower surface of the silicone gel breast implant, but this It is not limited.

In addition, FIG. 3 is a diagram illustrating a case in which the inner layer 12 is laminated on the entire surface inside the silicon shell 11, and the inner layer 12 is laminated on one surface inside the silicon shell 11. Compared to that, the metal-organic skeleton may be included in a relatively large amount, and thus leakage of silicone oil may be minimized. Therefore, while minimizing the leakage of the silicone oil, it is necessary to properly control the patient to the extent that heterogeneity or discomfort is not severe.

When the inner layer 12 is laminated on one surface inside the silicon shell 11 , the portion may appear as a junction structure, but is not limited thereto, and the inner layer 12 inside the silicon shell 11 . ) as a method of laminating, it may not be in the form of attaching by using a separate patch.

In addition, when the inner layer 12 is present on one surface inside the silicon shell 11 , the thickness of the portion where the inner layer 12 is not laminated inside the silicon shell 11 and the inside of the silicon shell 11 . The thickness of the portion on which the inner layer 12 is laminated is not limited, but preferably the portion where the inner layer 12 is not laminated inside the silicon shell 11 and the inner layer inside the silicon shell 11 . (12) When the thickness of the laminated part is uniform, the swelling phenomenon can be minimized by relieving the stress through the thickness deviation.

In addition, since the silicone gel is filled inside the silicone without a separate treatment on the silicone shell in the conventional silicone gel breast implant, the swelling of the shell is inevitable when the silicone oil in the silicone gel leaks. Since there is an inner layer laminated inside the silicone shell according to an embodiment, the swelling phenomenon can be significantly suppressed.

The silicone gel filled in the silicone gel breast implant 100 may be an organosiloxane polymer (polyorganosiloxane). The organosiloxane polymer is dimethylsiloxane, methyl hydrogen siloxane, methyl phenyl siloxane, diphenyl siloxane, dimethyl vinyl siloxane, and trifluoropropyl At least one may be selected from the group consisting of tri-fluoro propyl siloxane, but the type is not particularly limited as long as the functional properties of the silicone gel breast implant 100 can be realized.

The silicone gel breast implant 100 may have a different shape depending on the insertion site or the purpose of the procedure, for example, may be inserted into various body parts such as the breast, nose, buttocks, forehead, etc., but the shape is particularly limited it's not going to be

The silicone shell 11 forming the outer shape of the silicone gel breast implant 100 may be manufactured by applying a silicone polymer dispersion to a mandrel having a desired shape and curing it. The silicone polymer dispersion may form an elastomeric coating on the mandrel, the coating may be cured and the solvent may be evaporated.

The inner layer 12 may have a thickness of 5 to 100 μm. In this case, the thickness of the inner layer 12 may be 5 μm or more, 15 μm or more, or 25 μm or more, and may be 100 μm or less, 90 μm or less, or 80 μm or less. If the thickness of the inner layer 12 is less than 5 μm, the effect of the inner layer 12 including the metal-organic skeleton may be insufficient to prevent leakage of silicone oil. When the thickness of the inner layer 12 exceeds 100 μm, the patient who has received the silicone gel breast implant may experience discomfort such as a feeling of foreign body.

In addition, the inner layer 12 may form a plurality of stacked structures. In this case, the plurality of stacked structures may be formed by stacking preferably 1 to 10 layers, more preferably 1 to 5 layers. When the laminated structure exceeds 10 layers, discomfort such as a feeling of foreign body may be caused to the patient who has received the silicone gel breast implant.

In addition, when the inner layer 12 is laminated inside the silicon shell 11, the thickness of the entire shell may be 100 ~ 1,000 ㎛. In this case, the thickness of the entire shell may be 100 μm or more, 200 μm or more, or 300 μm or more, and may be 1,000 μm or less, 900 μm or less, or 800 μm or less. If the thickness of the entire shell is less than 100 μm, the silicone shell 11 may rupture even with a small stimulus, and if the thickness of the entire shell is more than 1,000 μm, the patient who has received the silicone gel breast implant may feel discomfort such as a foreign body. may cause

The metal of the metal-organic framework may be one selected from the group consisting of alkali metals, alkaline earth metals, transition metals, post-transition metals, metalloids, and combinations of two or more thereof. Preferably Li, Na, K, Rb, Be, Mg, Ca, Sr, Ba, Ti, Zr, Hf, V, Nb, Ta, Cr, Mo, W, Mn, Re, Fe, Ru, Os, Co , Rh, Ir, Ni, Pd, Pt, Cu, Ag, Au, Zn, Cd, Hg, Al, Ga, In, Tl, Si, Ge, Sn, Pb, As, Sb, Gd, Sc and Bi and these It may be one selected from the group consisting of a combination of two or more of them. More preferably, it may be one selected from the group consisting of Fe, Zn, Gd, Zr, Sc, Mg, Ni, Co, Cr, and a combination of two or more thereof. The metal-organic skeleton composed of these metal components has excellent biocompatibility and may be suitable for application to medical devices such as breast implants.

The metal-organic framework is MIL-101, MIL-88A, MIL-88Bt, MIL-100, MIL-53, MOF-74, UiO-66, UiO-67, ZIF-8, ZIFs, HKUST-1, M2 ( dobpdc), NU-1000, PCN-222, PCN-224, derivatives thereof, and a combination of two or more thereof may be one selected from the group consisting of, preferably MIL-101, MIL-88A, MIL-88Bt, MIL It may be one selected from the group consisting of -100, MIL-53, MOF-74, UiO-66, derivatives thereof, and combinations of two or more thereof. The metal-organic framework has excellent interaction with the silicone gel, so it can be uniformly dispersed inside the filling, and as a material with excellent biocompatibility, it can be suitable for application to medical devices such as breast implants. MIL-based metal-organic frameworks such as MIL-101, MIL-88A, MIL-88Bt, MIL-100, and MIL-53 and UiO-based metal-organic frameworks such as UiO-66 are obtained from Materials of Institute Lavoisier or University of Oslo. It refers to the first synthesized metal-organic framework.

The method for preparing the metal-organic framework may include mixing a metal precursor, an organic solvent, and an organic ligand and then stirring at 15 to 50° C., and as described above, the metal precursor is an alkali metal, an alkaline earth metal, a transition It may include one selected from the group consisting of metals, post-transition metals, metalloids, and combinations of two or more thereof. Preferably Li, Na, K, Rb, Be, Mg, Ca, Sr, Ba, Ti, Zr, Hf, V, Nb, Ta, Cr, Mo, W, Mn, Re, Fe, Ru, Os, Co , Rh, Ir, Ni, Pd, Pt, Cu, Ag, Au, Zn, Cd, Hg, Al, Ga, In, Tl, Si, Ge, Sn, Pb, As, Sb, Gd, Sc and Bi and these It may be one selected from the group consisting of a combination of two or more of them. More preferably, it may be one selected from the group consisting of Fe, Zn, Gd, Zr, Sc, Mg, Ni, Co, Cr, and a combination of two or more thereof.

The organic solvent is dimethylformamide, diethylformamide, N-methyl-2-pyrrolidone, dimethyl sulfoxide, dimethylacetamide ( dimethylacetamide), methanol, ethanol, water, and a combination of two or more thereof may be selected from the group consisting of

In the method for preparing the metal-organic skeleton, the organic ligand is carboxylic acid, fumaric acid, terephthalic acid, phthalic acid, trimseic acid, imidazole ( imidazole), derivatives thereof, and combinations of two or more thereof may be selected from the group consisting of. Preferably polycarboxylate (polycarboxylate), terephthalate (terephthalate), benzene-1,3,5-tricarboxylate (benzene-1,3,5-tricarboxylate), 2,5-deoxyhydroterephthalate (2) ,5-dihydroxyterephthate), biphenyl-4,4'-dicarboxylate (biphenyl-4,4'-dicarboxylate), imidazolate (imidazolate), may be one selected from the group consisting of triazolate (triazolate) .

The content of the metal-organic skeleton may be 5 to 20% by weight based on the total weight of the inner layer. In this case, the content of the metal-organic skeleton is 5 wt% or more, 7 wt% or more, or 9 wt% or more, and 20 wt% or less, 18 wt% or less, or 16 wt% or less with respect to the total weight of the inner layer. can When the content of the metal-organic skeleton is less than 5% by weight, the density of the metal-organic skeleton in the inner layer may decrease, and the amount of the metal-organic skeleton that leaks as the silicone gel breast implant ruptures is reduced, thereby preventing leakage may decrease. If the content of the metal-organic skeleton is more than 20% by weight, when the patient implanted with the implant moves, flow in the inner layer may occur, causing pain.

The metal-organic framework may have an average particle diameter of 1 to 100 nm. In this case, the average particle diameter of the metal-organic framework may be 1 nm or more, 11 nm or more, or 21 nm or more, and 100 nm or less, 90 nm or less, or 80 nm or less. If the average particle diameter of the metal-organic framework is less than 1 nm, the electrostatic repulsion properties between particles may be lowered and aggregation between particles may occur, and if the average particle diameter of the metal-organic framework exceeds 100 nm, the silicone gel breast implant (100 ) may have a negative effect on the physical properties or tactile feel, or the dispersibility may be reduced, and the thickness of the entire shell in which the inner layer 12 is laminated inside the silicon shell 11 may be increased.

The average diameter of the pores of the metal-organic framework may be 0.1 to 4.0 nm. In this case, the average diameter of the pores of the metal-organic framework may be 0.1 nm or more, 0.6 nm or more, or 1.1 nm or more, and 4.0 nm or less, 3.5 nm or less, or 3.0 nm or less. If the average particle diameter of the pores of the metal-organic framework is less than 0.1 nm, the silicone oil encapsulation rate may be appropriately lowered, and if the average diameter exceeds 4.0 nm, the silicone oil supported in the pores is the metal-organic framework. can be easily separated from

The metal-organic framework may have a surface area of 500 to 5,000 m ² g ⁻¹ . In this case, the surface area of the metal-organic skeleton is 500 m ² g ^-1 or more, 600 m ² g ^-1 or more, or 700 m ² g ^-1 or more, and 5,000 m ² g ^-1 or less, 4,900 m ² g ^{-1 or more.} or less, or 4,800 m ² g ^-1 or less. When the surface area of the metal-organic framework is out of the above range, the ability of the metal-organic framework particles to absorb or retain the silicone oil may be reduced.

Typically, a silicone gel breast implant may include a shell and a silicone gel filled inside the shell, and the silicone gel can maintain the shape of the shell and impart a texture similar to skin tissue. At this time, the low molecular weight silicone oil contained in a large amount inside the shell may cause swelling of the shell, thereby reducing the durability of the shell and promoting the leakage of silicone oil into the body.

In addition, the external texture of the silicone gel breast implant 100 may be made of micro, macro, and smooth texture, but is not limited thereto. However, due to the roughness of the texture, the biocompatibility is poor and it can cause side effects such as spherical contracture, which can act independently of the leakage of silicone oil.

The cross-sectional shape of the silicone gel breast implant 100 may be one selected from a circle, an oval, and a teardrop, but is not limited thereto. In general, since a user's breast shape, shape, etc. are formed differently for each user, it is preferable to select the type of the silicone gel breast implant 100 in consideration of the innate shape and the preference of the user's desired shape, shape, size, etc. .

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

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

100: silicone gel breast implant
10: a structure in which an inner layer is laminated on the inside of a silicon shell
11: silicone shell
12: inner layer

Claims (10)

silicone shell; and
Including; an inner layer laminated inside the silicon shell;
The inner layer comprises a metal-organic framework of a porous structure, silicone gel breast implant. According to claim 1,
The inner layer is laminated on one side or the entire surface of the inside of the silicone shell, silicone gel breast implants. According to claim 1,
The thickness of the inner layer is 5 ~ 100㎛, silicone gel breast implant. According to claim 1,
The metal of the metal-organic framework is one selected from the group consisting of alkali metals, alkaline earth metals, transition metals, post-transition metals, metalloids, and combinations of two or more thereof, silicone gel breast implants. According to claim 1,
The metal-organic framework is MIL-101, MIL-88A, MIL-88Bt, MIL-100, MIL-53, MOF-74, UiO-66, UiO-67, ZIF-8, ZIFs, HKUST-1, M2 (dobpdc), NU-1000, PCN-222, PCN-224, a silicone gel breast implant which is one selected from the group consisting of derivatives thereof, and combinations of two or more thereof. According to claim 1,
The content of the metal-organic framework is 5 to 20% by weight based on the total weight of the inner layer, silicone gel breast implant. According to claim 1,
The metal-organic framework has an average particle diameter of 1 to 100 nm, a silicone gel breast implant. According to claim 1,
The average diameter of the pores of the metal-organic framework is 0.1 ~ 4.0 nm, silicone gel breast implant. According to claim 1,
The surface area of the metal-organic framework is 500 ~ 5,000 m ² g ^-1 of, silicone gel breast implant. According to claim 1,
The cross-sectional shape of the silicone gel breast implant is one selected from a circle, an oval, and a teardrop.

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