KR20210046223A - A silicone oil leakage detective silicone gel-filled breast prosthesis - Google Patents

Abstract

One embodiment of the present invention provides a silicone gel-filled breast prosthesis comprising: a filler comprising a silicone gel and a metal-organic framework; and a silicone shell surrounding the filler.

Description

A silicone gel breast implant with a silicone oil leak detection function {A SILICONE OIL LEAKAGE DETECTIVE SILICONE GEL-FILLED BREAST PROSTHESIS}

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 containing a metal-organic skeleton.

Silicone gel-filled breast prosthesis is characterized by superior durability and texture compared to silicone gel breast implants or saline breast implants by filling silicone gel with an appropriate viscosity inside the silicone shell that forms the outer skin of the implant. . These silicone gel breast implants are grade 4 medical devices and require special biocompatibility or stability. In the implant industry, physical properties required as medical devices have been secured by adjusting the thickness of the silicone shell or changing the components of the filling material.

However, silicone gel breast implants still have a potential risk of side effects after implantation. For example, tissue necrosis, bacterial infection, globular constriction, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and implant rupture (breast implant) due to poor filling components or implant texture. rupture), etc. may occur. In particular, patients with spherical constriction must undergo reoperation, and patients with BIA-ALCL bear the risk of death.

Among the side effects of the aforementioned breast implant implantation, the most frequently occurring is implant rupture. When the silicone gel breast implant is ruptured, the silicone gel filled inside the implant may leak to the outside. As the silicone gel leaks, an inflammatory reaction may occur inside the human body, and further, it may cause extreme pain or capsular contracture in the patient due to an overactive immune response.

In order to cope with the rupture of the implant, it is most important to detect it early and prevent excessive leakage of silicone gel. In the case of rupture of the existing silicone gel breast implant, it was only diagnosed whether the implant was ruptured according to the judgment of the medical staff, but it was difficult to externally identify whether the implant was ruptured, and there was a limitation in the accuracy of diagnosis.

The present invention is to solve the problems of the prior art described above, and an object of the present invention is to easily identify whether the implant is ruptured by introducing a metal-organic framework (MOF) inside the silicone gel, and It is to provide a silicone gel breast implant that can improve the accuracy of diagnosis.

One aspect of the present invention is a silicone gel and a metal-filling material comprising an organic skeleton; And it provides a silicone gel breast implant consisting of; and a silicone shell surrounding the filling.

In one embodiment, the metal-organic skeleton is iron (Fe), zinc (Zn), gadolinium (Gd), zirconium (Zr), scandium (Sc), magnesium (Mg), nickel (Ni), cobalt (Co ), chromium (Cr), and a combination of two or more of them may be included.

In one embodiment, the metal-organic skeleton is MIL-101, MIL-88A, MIL-88Bt, MIL-100, MIL-53, MOF-74, UiO-66 and derivatives thereof, and combinations of two or more thereof. It may be one selected from the group consisting of.

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

In one embodiment, the average particle diameter of the metal-organic skeleton may be 1 ~ 100 nm.

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

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

In one embodiment, the thickness of the silicon shell may be 200 ~ 1,000 ㎛.

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

Another aspect of the present invention is (a) manufacturing a silicone shell by immersing a breast-shaped mold in a silicone solution; (b) drying and curing the silicone shell attached to the mold; (c) forming a hole in the lower end of the silicone shell attached to the mold to obtain the silicone shell; (d) forming a patch hole, which is a portion to which the patch is bonded to the silicone shell; (e) forming a patch according to the shape of the patch hole; (f) a patch bonding step of bonding the molded thin film patch and the patch structure of the patch and the bonding material onto the patch hole of the silicon shell; (g) forming an injection groove to inject a filling material into the inner space of the silicon shell; And (h) introducing the filling material through the injection groove.

According to an aspect of the present invention, the silicone gel breast implant is a metal-organic framework (MOF) inside the silicone gel to easily identify whether the implant is ruptured, and to help the medical staff improve the accuracy of the diagnosis. can do.

The effects of the present invention are not limited to the above effects, and should be understood to include all effects that can be deduced 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 composed of a filler including a metal-organic skeleton and a silicone shell surrounding the filler according to an embodiment of the present invention.

Hereinafter, the present invention will be described with reference to the accompanying drawings. However, the present invention may be implemented in various different forms, and therefore is not limited to the embodiments described herein. In the drawings, parts irrelevant to the description are omitted in order to clearly describe the present invention, and similar reference numerals are attached to similar parts throughout the specification.

Throughout the specification, when a part is said to be "connected" with another part, this includes not only "directly connected" but also "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, not excluding other components, unless specifically stated to the contrary.

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

The term "metal-organic framework (MOF)" as used herein refers to a unit in which a metal ion or a metal ion cluster is coordinated with an organic ligand or an organic linker is regularly or irregularly It is an organic-inorganic hybrid material formed by being arranged in a row. In this case, the metal-organic skeleton may be formed in a one-dimensional, two-dimensional, or three-dimensional structure.

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

Silicone gel breast implants

1 is a cross-sectional view of a silicone gel breast implant composed of a filler including a metal-organic skeleton and a silicone shell surrounding the filler according to an embodiment of the present invention.

Referring to FIG. 1, a silicone gel breast implant 10 according to an aspect of the present invention includes a silicone gel and a metal-filling material including an organic skeleton; And a silicone shell 12 surrounding the filler material 11.

In the silicone gel breast implant 10 according to the present invention, the metal-organic skeleton interacts with the silicone gel to be uniformly dispersed inside the filling material 11. When the metal-organic skeleton is uniformly dispersed, even if a rupture occurs at any location of the silicone shell 12, the silicone gel breast implant 10 can be easily obtained through X-ray examination or computerized tomography (CT). Rupture can be detected.

In the artificial breast implant, when the silicone shell 12 surrounding the filling 11 is ruptured, the filling 11 may leak through gaps generated by the rupture. As the filler material 11 leaks through the gaps, not only the silicone gel but also the metal-organic skeleton may leak. And by detecting the leaked metal-organic skeleton through X-ray examination or CT, rupture of the silicone gel breast implant 10 can be detected early.

The metal of the metal-organic skeleton 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 of them. 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 combinations of two or more of them. The metal-organic skeleton composed of such a metal component is excellent in biocompatibility and may be suitable for application to medical devices such as breast implants.

The metal-organic skeleton 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 combinations of two or more of them, 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 of them. Such a metal-organic skeleton is excellent in interaction with the silicone gel, so that it can be uniformly dispersed inside the filler material 11, as well as being a material excellent in biocompatibility, it can be suitable for application to medical devices such as breast implants. MIL-based metal-organic skeletons such as MIL-101, MIL-88A, MIL-88Bt, MIL-100, and MIL-53 and UiO-based metal-organic skeletons such as UiO-66 are from Materials of Institute Lavoisier to University of Oslo. It refers to the first synthesized metal-organic skeleton.

The method of manufacturing the metal-organic skeleton may include a step of 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, and a transition. It may include one selected from the group consisting of a metal, a post-transition metal, a metalloid, and a combination of two or more of them. 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 combinations of two or more of them.

As a non-limiting example of the present invention, the organic solvent is dimethylformamide, diethylformamide, N-methyl-2-pyrrolidone, dimethyl sulfoxide. Side (dimethyl sulfoxide), dimethylacetamide (dimethylacetamide), methanol, ethanol, water, and may be one selected from the group consisting of a combination of two or more of these.

As a non-limiting example of the present invention, in the method for preparing the metal-organic skeleton, the organic ligand is carboxylic acid, fumaric acid, terephthalic acid, phthalic acid, trimes It may be one selected from the group consisting of acids (trimseic acid), imidazole (imidazole), derivatives thereof, and combinations of two or more of them. Preferably polycarboxylate, terephthalate, benzene-1,3,5-tricarboxylate, 2,5-dioxyhydroterephthalate (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 filler material 11. At this time, the content of the metal-organic skeleton is 5% by weight or more, 7% by weight or more, or 9% by weight or more, 20% by weight or less, 18% by weight or less, or 16% by weight based on the total weight of the filler material 11 May be less than or equal to %. If the content of the metal-organic skeleton is less than 5% by weight, the density of the metal-organic skeleton in the silicone gel breast implant 10 may decrease, and the metal-organic skeleton leaks as the silicone gel breast implant 10 is ruptured. A decrease in the amount of X-ray or CT results may decrease the accuracy of the results. If the content of the metal-organic skeleton is more than 20% by weight, the compatibility of the metal-organic skeleton and the silicone gel may be reduced, and when the patient implanted with the implant moves, the flow in the silicone gel breast implant 10 occurs, causing pain. Can cause.

The average particle diameter of the metal-organic skeleton may be 1 to 100 nm. In this case, the average particle diameter of the metal-organic skeleton 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 skeleton is less than 1 nm, the electrostatic repulsion characteristics between particles may be deteriorated, resulting in particle aggregation, and when the average particle diameter of the metal-organic skeleton is more than 100 nm, the silicone gel breast implant (10 ) May negatively affect the physical properties or tactile feel or deteriorate dispersibility.

The average diameter of the pores of the metal-organic skeleton may be 0.1 to 4.0 nm. At this time, the average diameter of the pores of the metal-organic skeleton 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. When the average diameter of the pores of the metal-organic skeleton is less than 0.1 nm or more than 4.0 nm, the amount of silicone gel adsorbed inside the metal-organic skeleton can be significantly reduced.

The surface area of the metal-organic skeleton may be ^{500 to 5,000 m 2} g ^-1. If the surface area of the metal-organic skeleton falls within the above range, the silicone gel may be adsorbed and the amount of the leaked silicone gel may be reduced. At this time, 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, 5,000 m ² g ^-1 or less, 4,900 m ² g ^-1 Or less, or 4,800 m ² g ^-1 or less. When the surface area of the metal-organic skeleton is ^{less than 500 m 2} g ^-1 or more than 5,000 m ² g ^-1, the amount of silicone gel adsorbed inside the metal-organic skeleton may be significantly reduced.

The silicone gel filled in the silicone gel breast implant 10 may be an organosiloxane polymer. The organosiloxane polymer includes dimethylsiloxane, methyl hydrogen siloxane, methyl phenyl siloxane, diphenyl siloxane, dimethyl vinyl siloxane, and trifluoropropyl. One or more may be selected from the group consisting of siloxane (tri-fluoro propyl siloxane), but the type is not particularly limited as long as the functional characteristics of the silicone gel breast implant 10 can be implemented.

The silicone gel breast implant 10 may have a different shape depending on the insertion site or the purpose of the procedure, and may be inserted into various body parts such as breast, nose, buttocks, forehead, etc., but the shape is particularly limited. It does not become.

The silicone shell 12 forming the outer shape of the silicone gel breast implant 10 may be prepared by applying a silicone polymer dispersion to a mandrel having a desired shape and curing it. The silicone polymer dispersion may form an elastomer film on the mandrel, and the film may be cured and the solvent may be evaporated.

The thickness of the silicon shell 12 may be 200 to 1,000 μm. In this case, the thickness of the silicon shell 12 may be 200 µm or more, 300 µm or more, or 400 µm or more, and may be 1,000 µm or less, 900 µm or less, or 800 µm or less. When the thickness of the silicone shell 12 is less than 200 µm or more than 1,000 µm, the amount of silicone gel adsorbed inside the metal-organic skeleton may be significantly reduced. If the thickness of the silicon shell 12 is less than 200 μm, the silicon shell 12 may be ruptured even with little stimulation. If the thickness of the silicone shell 12 is more than 1,000 μm, the patient who has received the silicone gel breast implant 10 may cause discomfort such as a foreign body sensation.

The cross-sectional shape of the silicone gel breast implant 10 may be one selected from a circle, an oval, and a teardrop, but is not limited thereto. In general, a user's breast shape and shape are formed differently for each user, so it is preferable to select the type of the silicone gel breast implant 10 in consideration of the natural shape and preferences such as the shape, shape, and size desired by the user. .

Silicone gel breast implant manufacturing method

A method of manufacturing a silicone gel breast implant 10 according to an aspect of the present invention includes the steps of: (a) immersing a breast-shaped mold in a silicone solution to prepare a silicone shell 12; (b) drying and curing the silicone shell 12 attached to the mold; (c) forming a hole in the lower end of the silicone shell 12 attached to the mold to obtain the silicone shell 12; (d) forming a patch hole, which is a portion to which the patch is bonded, to the silicon shell 12; (e) forming a patch according to the shape of the patch hole; (f) a patch bonding step of bonding the molded thin film patch and the patch structure of the patch and the bonding material onto the patch hole of the silicon shell 12; (g) forming an injection groove 13 to inject the filling material 11 into the inner space of the silicon shell 12; And (h) introducing the filler material 11 through the injection groove 13.

The above description of the present invention is for illustrative purposes only, and those of ordinary skill in the art to which the present invention pertains will be able to understand that other specific forms can be easily modified 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 and non-limiting in all respects. For example, each component described as a single type may be implemented in a distributed manner, and similarly, components described as being distributed may also be implemented in a combined form.

The scope of the present invention is indicated by the claims to be described later, and all changes or modified forms derived from the meaning and scope of the claims and their equivalent concepts should be construed as being included in the scope of the present invention.

10: silicone gel breast implant
11: Fill containing metal-organic skeleton
12: silicone shell
13: Silicone oil injection groove

Claims (10)

A filler comprising a silicone gel and a metal-organic skeleton; And
A silicone shell surrounding the filling; consisting of, silicone gel breast implants. The method of claim 1,
The metal of the metal-organic skeleton 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 of them, silicone gel breast implants. The method of claim 1,
The metal-organic skeleton 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 one selected from the group consisting of a combination of two or more of them, a silicone gel breast implant. The method of claim 1,
The content of the metal-organic skeleton is 5 to 20% by weight based on the total weight of the filler, silicone gel breast implant. The method of claim 1,
The average particle diameter of the metal-organic skeleton is 1 ~ 100 nm, silicone gel breast implant. The method of claim 1,
The average diameter of the pores of the metal-organic skeleton is 0.1 ~ 4.0 nm, silicone gel breast implant. The method of claim 1,
The surface area of the metal-organic skeleton is 500 ~ 5,000 m ² g ^-1 , silicone gel breast implant. The method of claim 1,
The thickness of the silicone shell is 200 ~ 1,000 ㎛, silicone gel breast implant. The method of claim 1,
The cross-sectional shape of the silicone gel breast implant is one selected from a circle, an oval, and a teardrop, a silicone gel breast implant. (a) manufacturing a silicone shell by immersing a breast-shaped mold in a silicone solution;
(b) drying and curing the silicone shell attached to the mold;
(c) forming a hole in the lower end of the silicone shell attached to the mold to obtain the silicone shell;
(d) forming a patch hole, which is a portion to which the patch is bonded to the silicone shell;
(e) forming a patch according to the shape of the patch hole;
(f) a patch bonding step of bonding the molded thin film patch and the patch structure of the patch and the bonding material onto the patch hole of the silicon shell;
(g) forming an injection groove to inject a filling material into the inner space of the silicon shell; And
(h) Injecting the filling material through the injection groove; comprising, a method for producing a silicone gel breast implant.

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