KR101032776B1 - The silicone breast implant which has low outflow of low molecular weight silicone - Google Patents

Abstract

The present invention relates to the fourth generation of silicone artificial breast implants that can minimize the outflow of low molecular weight silicone material to ensure the biosafety of the implant, and also to maintain a more stable wear to the patient after insertion of the human body by the weight of the implant.

All components of the silicone artificial breast implant according to the present invention are made of dimethyl siloxane, a derivative thereof, and a copolymer thereof, that is, an organosiloxane polymer (hereinafter referred to as silicone), which is capable of organ transplantation, and a gel in a silicone pocket. It is filled with (Gel) silicon and a specially formulated double-porous silicon sponge grain. The present invention minimizes the low-molecular-weight silicone outflow caused by filling the gel-type silicon to minimize side effects such as foreign body reactions that may occur after insertion into the human body, excellent in biocompatibility and safety, and the inconvenience felt by weight increase due to implant insertion It provides silicone breast implants to minimize the possibility of disease such as disc, scoliosis, etc., which can occur due to the increase of weight and chest weight.

Artificial Breast, Silicone, Organosiloxane, Silicone Granule, Silicone Sponge Bead

Description

The silicone breast implant which has low outflow of low molecular weight silicone}

The present invention relates to a silicone prosthesis implant, and all components are made of organ transplantable silicone (Polyorganosiloxane; typically Polydimethylsilicone and derivatives thereof, for example, polymethylvinylsiloxane, Polydiphenylsiloxane, Fluorosilicone) The present invention relates to a silicone artificial breast implant having a form of a double-porous silicon sponge bead specially manufactured with a gel-type silicone and a silicone or a derivative thereof.

The silicone artificial breast implant according to the present invention has excellent biocompatibility and safety by minimizing the outflow of low molecular weight silicone material generated by filling the silicon in gel form and minimizing side effects such as foreign body reactions that may occur after insertion into the human body. Discomfort that is felt by the weight increase due to implant implantation and the possibility of disease such as scoliosis and scoliosis that may occur due to an increase in the weight of the chest can be minimized.

In general, breast implants are used for the reconstruction of breast defects due to diseases and accidents, and for cosmetic surgery and plastic surgery due to malformations, and are used for the replacement of organs or tissues three-dimensionally and anatomically.

Prosthetic breast implants are filled with saline, hydro-gel, and silicone gel, filled in a shell made of silicone that can be transplanted into organs. And products in the form of water droplets (Anatomical type) and smooth or rough form depending on the surface condition, and can be summarized in more detail as described below.

Saline breast prosthesis is an implantable or implantable artificial breast implant in the form of a silicone (consisting of polyorganosiloxane, such as polydimethylsiloxane or polydiphenylsiloxane), which is structurally composed of a silicone shell and a valve. .

Since saline artificial breast implants use sterile saline as a filler, the breast volume can be changed by guaranteeing the safety of the filling in the body after rupture and controlling the amount of saline filling. It is remarkably dropped and has a disadvantage in that the shell durability is weak because most of the stress applied to the outside is directly received from the shell.

Hydrogel-filled breast prosthesis is a form of a hydrogel consisting of monosaccharides and polysaccharides in the shell as in saline artificial breast implants. It is a product developed on the principle of absorption and excretion by the human body.

However, hydrogel artificial breast implants have not been proven to be safe for long-term use, have a large volume change over time after insertion and a high possibility of wrinkles, and have an unnatural feel compared to silicone artificial breast implants.

At present, such hydrogel artificial breast implants are not on the market due to the issue of safety verification as of 2000.

Silicone gel-filled breast prosthesis is a form filled with silicone gel of moderate viscosity inside the shell, and the durability and feel of the product is superior to saline artificial breast implants and other implants.

Due to this advantage of effectiveness, the sale of artificial breast implants in the market is dominated by the sale of silicone artificial breast implants.

The development history of silicone artificial breast implants has been developed as first generation implants, second generation implants, and third generation implants, and the details are as follows.

The first generation of silicone artificial breast implants, sold from the mid-1960s to the mid-1970s, was first developed by Cronin and Gerow in 1961, and can be summarized by the use of thick shells, smooth surface types, and high viscosity silicone gels. . This implant caused gel bleed and capsular contracture, but the rupture rate was low due to the use of thick shells.

Second-generation silicone artificial breast implants were sold from the mid-1970s to the mid-1980s, using thin shells and low-viscosity silicone gel fills for a softer feel. This implant is characterized by similar gel runoff, high rupture rate, and low spherical buildup rate compared to first generation implants.

The 3rd generation silicone artificial breast implants have been sold from the mid-1980s to the present, using a gel barrier layer to block gel outflow, and a thick shell and high viscosity silicone compared to the second generation. Gel is the form used. In addition, a rough surface product (Texture type) has been developed to reduce spherical construction.

The 3rd generation silicone breasts show lower burst and spherical buildup rates than the 1st and 2nd generation breast implants. This is because the gel outflow barrier layer is used inside the shell to maximize the mechanical properties of the shell and is believed to be due to the minimum amount of silicone gel outflow into the tissue of the implanted part of the body.

As described above, current silicone breast implants have been completed up to the third generation of silicone breast implants through several improvement processes with a focus on safety and effectiveness, but further advances are in poor stage.

This is because the design problems of safety and effectiveness in silicone artificial breast implants play a confrontational role and have limitations in product improvement.

The problems and limitations of the silicone artificial breast implants will be described in more detail below.

Basically, in the case of silicone artificial breast, it replaces the female breast tissue, so it should be able to maintain the softness of the breast tissue in the texture. Therefore, the lower the viscosity or cohesion of the filling silicone gel and the thinner the shell, the more effective the performance.

However, low viscosity or cohesive silicone gels and thin shells contribute to poor product safety. As shown in the second generation of breast implants, the thin shell exhibits a high rate of rupture after insertion into the body due to its low durability. Likewise, low viscosity or cohesive silicone gels have a widespread outflow of the silicone gel after rupture of the implant. This may occur, and once leaked the silicone gel becomes difficult to remove.

In particular, a silicone gel of too low a viscosity (silicone gel of the viscosity that flows) is widely spilled into the body, and has a possibility of serious side effects such as tissue necrosis by coating on the organs after the spill.

In addition, the silicone gel used as a filler contains a large amount of a low molecular weight silicone oil component, and such an oil component (low molecular weight silicon molecules) causes swelling of the shell made of silicon.

This swelling phenomenon of the shell causes a decrease in strength and elasticity of the shell which is directly connected to the durability of the product.

And the swelling phenomenon by the silicone gel is carried out through the shell of the comparatively low molecular weight silicone molecules contained in the silicone gel (especially those having a molecular weight of 1500 Da or less, as mentioned in the FDA). Further accelerating the outflow, the outgoing low-molecular-weight silicon molecules are still not fully debated about body safety.

However, no technology has been developed that can completely exclude the outflow of these low molecular weight silicon molecules.

This is due to the use of gel in the form of silicone. Gel-type silicon is weakly molecularly bonded to the network, and the looseness of the binding network allows the low molecular weight silicon molecules to be sufficiently discharged.

In the case of silicone gel prosthetic breast implants due to the low molecular weight of silicone gel (which is directly related to viscosity or cohesion), the silicone gel artificial breast implants have been used by the US Food and Drug Administration (FDA) due to the demonstration of their safety and effectiveness. Although limited, it was officially licensed again in 2006 with the development of a cohesive gel-filled silicone artificial breast product that is highly cohesive.

The cohesive silicone gel, which is used as a filler in cohesive gel-filled artificial breast implants, is a cohesive silicone gel that is more cohesive than conventional silicone gels, and maintains its shape even when the implant is ruptured and minimizes the possibility of extensive body leakage. It has advantages.

However, even in the case of high viscosity cohesive silicone gel fillers, there is a difference in flow rate due to the difference in molecular weight, but the problem of low molecular weight silicon outflow mentioned above cannot provide a fundamental solution.

For the purpose of solving the above-mentioned degradation of the physical properties and bleeding of the gel by swelling, a silicone implant has been developed in which a barrier film is provided inside the shell to block the leakage of existing low molecular weight silicone components as described in USP4455691. .

These barrier films are made of structurally stable silicone polymers with high molecular orientation and density of silicone polymers and high bonding strength between polymers. Thus, low molecular weight silicone oil molecules are difficult to physically and chemically pass through these barrier films. It is made.

In the case of artificial breasts containing such barriers, mechanical properties and low molecular weight silicone oils are reduced compared to products without barriers.

As a result, the artificial breasts provided with the barrier film have excellent durability compared to the artificial breasts which are not, and the incidence of spherical contraction is reduced.

However, these barriers also blocked much of the external leakage of silicone oil, but still a large amount of molecules of silicone oil flow through the shell of the artificial breast (0.0011 g / cm ² / week, Source: US FDA PMA Technical Report)

In addition, the Korean Patent Publication No. 2008-0034089 (April 18, 2008) includes an elastic shell at least partially filled with a biocompatible silicone particulate material in order to prevent and confirm the outflow of low molecular weight silicone oil. Breast implants have been developed in which cells are filled with a plurality of about 1 micron diameter micro balloons, each cell having one or more such that it is detected by external X-ray diagnostic equipment. The inclusion of a tracer makes it easy to detect when the body leaks.

In Korean Patent No. 882593 (April 21, 2008), a foamed silicone sponge is put into a silicone block or a cohesive gel bag and bonded using a liquid spray adhesive, or a vacant silicone capsule in a silicone block or a cohesive gel bag. Lightweight silicone implants are known which have been bonded using a liquid spray adhesive.

However, the lightweight silicone implants are limited to weight reduction, and thus the problem of silicon leakage is still not solved.

In Korean Patent Publication No. 2008-95023 (2008.10.28.), Two-component silicone is mixed and cured into a solid using a platinum catalyst as a curing agent, but a medical grade foaming agent is added to the silicone or is cured. By directly introducing nitrogen into the foam, a foam sponge breast implant of a solid material rather than a gel is known.

However, the foam foam breast prosthesis of the solid material has not been developed in the present technology has been developed a silicone foam that can be permanently implanted, and even if this is possible, the conditions of addition of the foaming agent to obtain an implantable foam sponge (foam amount, foaming agent, The degree of foaming is not practically technically possible because it is not technically feasible in the field, so it is practically impossible to use commercially, and the technical value is very thin.

As discussed above, to summarize the development process of silicone breast implants, conventional silicone breast implants are similar to the texture of actual breast tissues and have superior advantages over other implants in terms of their effectiveness. Since there is room for supplementation in terms of the safety of implants, such as body leakage problems, cohesive silicone gel fillers with high viscosity of gels are used to improve the supplementation. In order to prevent the leakage of the low molecular weight silicone components generated from the silicone gel, the product has been supplemented and developed many times, such as the installation of a barrier to block the leakage of the silicone oil.

However, despite such development, it is not possible to completely block the outflow of the silicone oil, and also does not completely block the outflow of the low molecular weight silicone material caused by the outflow of the silicone oil.

Therefore, the strength reduction of the implant by the swelling phenomenon of the shell due to the outflow of the silicone oil and ensuring the safety of the inflow of the low molecular weight silicone material remain urgently and completely solved.

Accordingly, the present invention has been invented to solve the above problems, after implantation of the implant body, the low molecular weight silicone component contained in the silicone gel used as the filling of the implant flows out of the implant shell (Shell) After inserting the human body, it prevents side effects from occurring in advance, prevents degradation of the durability of the implant shell due to the swelling phenomenon caused by the outflow of low molecular weight silicone gel components, and significantly lowers the burst rate of the implant shell. It is an object of the present invention to provide a silicone artificial breast implant.

In addition, by improving the safety of the implants related to the silicone outflow and by reducing the weight of the implants, safety is minimized by the possibility of discomfort caused by the weight increase due to the implant insertion and the possibility of disease such as disc, scoliosis, etc. It is an object of the present invention to provide a fourth generation of silicone artificial breast implants that have been improved.

In order to solve the above problems, the prosthesis of the present invention uses a silicone gel as a fill material of the prosthesis, and is made of a double made of dimethylsiloxane, a derivative thereof, and an organic siloxane polymer (Polyorganosiloxane) which can be transplanted for a long time. The microporous structure of the silicon sponge (Sponge) particles (Bead) is characterized in that the mixed use of the silicone gel, the external structure of the double microporous structure of the silicone sponge grains are open pore (Open pore or Open cell) And the internal structure is characterized in that the double structure of the closed pore (Close pore or Close cell).

The artificial breast implant according to the present invention uses a mixture of silicone gel and double microstructured silicon sponge grains as a filler, thereby minimizing the outflow of silicone oil components including low molecular weight silicone components out of the implant shell. , To minimize the reduction of the durability of the implant shell due to the swelling phenomenon, to reduce the bursting rate of the implant, and to prevent the leakage of low molecular weight silicone oil into the body after insertion of the implant and the side effects thereof. There is.

In addition, in addition to improving the safety of the implant related to the silicone outflow as described above, the weight of the implant is minimized, thereby minimizing the discomfort felt by sudden breast weight increase after implant insertion and the possibility of disease such as disc, scoliosis, etc. There is an effect that can provide an improved artificial breast implant safety.

The prosthesis of the present invention uses a silicone gel as a filler of the prosthesis, and is a silicone sponge of a double microporous structure specially made of dimethyl siloxane, a derivative thereof, and an organic siloxane polymer (Polyorganosiloxane) which can be transplanted for a long time. (Sponge) It is characterized in that the use (Bead) mixed with the silicon gel, the outer structure of the double microporous silicon sponge grains is an open pore (Open pore or Open cell) and the inner structure is a closed pore ( Close pore or Close cell) is characterized in that the dual structure.

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

1 is a cross-sectional view showing the shape of a conventional artificial breast implant. The silicon gel 20a is filled in a silicon pocket formed of the silicon shell 10a and the bonding portion 30a.

As described above, in the conventional artificial breast implant, the swelling phenomenon of the shell due to the outflow of the low molecular weight silicone oil component contained in the silicone gel used as the filling and the inflow of the low molecular weight silicone oil were inevitable.

However, as shown in Fig. 2, the artificial breast implant of the present invention is a silicone gel 20b and a double microstructured silicon sponge grain 40 in a silicon pocket consisting of a silicon shell 10b and a junction 30b. It is characterized by the form in which the mixture of the mixture is filled.

All the constituent materials of the artificial breast implant of the present invention as shown in FIG. 2 are made of an organosiloxane polymer (Polyorganosiloxane) material.

The organic siloxane polymer (Polyorganosiloxane) that can be used in the above is an implant grade (Implant) that can secure safety after implantation, using the following materials.

Basically, the main chain of the organosiloxane polymer (Polyorganosiloxane) is silane, and the silane main chain is in the form of an organic group such as a methyl group.

Most representative examples thereof include polydimethylsiloxane having a methyl group in the main chain, and the methyl group of dimethylsiloxane, which is a monomer of the polydimethylsiloxane, is an alkyl group, a phenyl group. It is possible to substitute the organic group (Organo group), such as) group, the vinyl (Vivyl group) group.

For example, the dimethylsiloxane may be methyl hydrogen siloxane, methyl phenyl siloxane, diphenyl siloxane, dimethyl vinyl siloxane, trifluoropropyl siloxane. (Tri-fluoro propyl siloxane) and the like can be produced by the polymerization of these monomers (Polymer) can be produced and used, and also a copolymer using the oligomer (Oligomer) consisting of the monomers (Monomer) Can be used.

Meanwhile, the artificial breast implant of the present invention uses a mixture of silicone gel and double microstructured silicon sponge grains as a filler.

Figure 3 shows the structure of the double microstructured silicon sponge granules according to the artificial breast implant of the present invention, the inside thereof takes the form of a closed cell structure as shown in 60, the outside is opened as shown in 70 It has a form of a cell structure.

4 to 6 are photographs showing the outer open cell of the double microporous structure silicone sponge beads filled in the artificial breast implant of the present invention, Figures 7 to 8 are photographs showing the inner close cell of the silicon beads.

Such micropores of the double structure absorb the oil component in the silicone gel used as the filling of the artificial breast implant to prevent leakage to the outside. That is, the open cell formed on the outside of the double microstructured silicon sponge grains maximizes the surface area so that a large portion of the sponge grains can be contacted and combined with the silicone gel, and the sponge grains are prevented from being separated from the silicone gel. The filling of to form one aggregate.

Such aggregate formation prevents the filling from spreading to other organs in the human body, even if the implant ruptures after implantation in the human body, and facilitates removal of the ruptured implant from the human body.

The principle of the interaction between the two materials used as the filling of the silicone artificial breast implant of the present invention, the silicone sponge granules and the silicone gel (particularly, the low molecular weight silicone oil component contained in the silicone gel) is as follows.

The low molecular weight silicone oil of the open cell of the silicone sponge granules and the silicone gel component has a high surface contact rate and the transfer rate between the silicones. Therefore, the low molecular weight silicone oil component having high fluidity due to the relatively low molecular weight among the silicone gel components has capillary action and entropy. The principle of reduction is to move towards the open cell of the silicon sponge grains.

The low-molecular-weight silicone oils, ie absorbed through the open-cells, close the cell through the foam wall of the open-cell formed outside of the silicone sponge pellets due to the molecular sparse structure of the silicone sponge pellet structure and the high flowability of the low molecular weight silicone oils. Will be reached directly.

Since the silicone oils reached directly to the closed cell are contained in the foam of the closed cell, the silicone oil including the low molecular weight silicone component is integrally combined with the silicon sponge grains, and thus it is impossible to leak out of the implant shell.

The production of such silicon sponge granules includes a molecular weight of 5,000 to 100,000 dimethyl siloxane containing methyl hydrogen siloxane, and a molecular weight of 5,000 to dimethylvinyl terminated siloxane containing a dimethylvinyl group at the terminal. Reaction of 100,000 dimethyl vinyl siloxane (dimethyl vinyl siloxane) and methylhydrogen siloxane equivalent ratio, the silicon sponge grains are prepared by the addition polymerization method using a platinum catalyst in the presence of less than 10% by weight of silica filler.

Next, sodium chloride (NaCl) and water (H ₂ O) are used to form an open cell and a closed cell foam of the silicon sponge grains.

That is, sodium chloride (NaCl) and water (H ₂ O) are used as a foaming material for foam formation. The average particle size of the sodium chloride may be used 100 ~ 700㎛, preferably 500㎛ for forming an open cell, 200㎛ for forming a closed cell is used. The particle size determines the pore size or cell size of the silicone sponge.

Accordingly, the average pore size or cell size of the inner closed cell foam structure of the double silicon silicon beads of the present invention is 100 to 700 µm, and the average of the outer open cell foam structure. Pore size (Pore size or Cell size) is 100 ~ 700㎛, Preferably, the average pore size of the inner closed cell form (Form) structure is 200㎛, of the external open cell form structure The average pore size is 500 μm.

In addition, the mixing amount of the sodium chloride used as the foaming material with the silicon raw material is 50 to 700% of the weight with respect to the silicon raw material, preferably 400% (that is, the weight ratio of silicon raw material and sodium chloride 1: 4). .

After mixing the silicon and sodium chloride as described above to make a silicon gum (Gum), the resulting silicon gum is prepared in the form of granules 2 ~ 4mm in diameter.

The surface of the silicon grains is buried three to four times with sodium chloride (NaCl) having an average particle size of 500 μm, and the addition of the silicon grains is carried out at 150 to 180 so that addition polymerization can be carried out perfectly using a platinum catalyst. The silicone is cured by heating for 2 to 5 hours at ℃.

In order to completely remove the sodium chloride used as foaming material in the cured silicone from the closed bead inside the silicon bead, the cured silicone beads (grains) were subjected to autoclaving using a high temperature steam sterilizer at a temperature of 120 ° C. to 160 ° C. and 1.2 to 1.5 atmospheres of water. And at least 24 hours under steam conditions.

Under high temperature water and high pressure steam, sodium chloride (NaCl) is dissolved into sodium ions (Na +) and chloride ions (Cl ⁻ ), and is removed by permeation of silicon with brine steam.

On the other hand, the mixing amount of the water used as the foaming material with the silicon raw material is 10 to 70% of the weight with respect to the silicon raw material, preferably 25% (that is, the weight ratio of silicon raw material and water 1: 0.25). This mixing ratio determines the pore density of the silicone sponge.

Next, the stirred mixture was placed in a 5 mm diameter mold and heated at 20 to 70 ° C. for 1 to 3 hours, and sodium chloride (NaCl) having an average particle size of 100 to 700 μm on the surface of the heated silicon grains. ) 3-4 times and then heated at 150-180 ℃ for 2-5 hours to cure the silicone.

Such a composition of the silicone sponge grains uses a molecular weight much lower than the silicon molecular weight used in the shell of artificial breast.

In other words, the silicon used in the shell of artificial breast is used to maintain the strength of the molecular weight of more than 1 million molecular weight to maintain its strength, while the silicone sponge grains by reducing the molecular weight to increase the structural coarseness by the entropy principle This is because the low molecular weight silicone oils absorbed by the silicon sponge grains can be prevented from leaking out of the implant.

Double microstructured silicone sponge beads according to the present invention were prepared through the following Examples 1-2.

Example  One

First, methyl hydrogen siloxane, platinum catalyst, dimethylsiloxane having a molecular weight of 5,000 to 100,000 with a silica filler content of less than 10% by weight, and dimethylvinyl terminated siloxane having a dimethylvinyl group at the terminal. The content of the silica filler contained less than 10% by weight of dimethyl vinyl siloxane (Dimethyl vivyl siloxane) having a molecular weight of 5,000 to 100,000 was mixed in a methylhydrogen siloxane equivalent ratio.

Next, the mixed silicon mixture and sodium chloride (NaCl) having an average particle size of 200 μm are mixed at a weight ratio of 1: 4 (silicon: sodium chloride) to form a silicon gum, and the resulting silicon gum is 2 to 4 mm in diameter. Prepared in the form of phosphorus pellets.

The surface of the silicon grains was buried three to four times with sodium chloride (NaCl) having an average particle size of 500 μm, and the polymerization of the silicon grains was carried out at 170 ° C. so that addition polymerization could be carried out perfectly using a platinum catalyst. The silicone was cured by heating at 3 hours.

In order to remove the sodium chloride used as the foaming material from the cured silicone, the cured silicon grains were heated for about 30 hours at 140 ° C. in water and 1.4 atm using a high pressure steam sterilizer.

In this way, the average pore size of the inner form structure is 200 µm, the average pore density is about 20.6ea / mm ² , and the average pore size of the outer form structure. size) of 500 μm, the average pore density (pore density) of about 2.8ea / mm ² to produce a silicone sponge beads.

Example  2

Includes methyl hydrogen siloxane and platinum catalyst, dimethylsiloxane with molecular weight of 5,000 to 100,000 with a silica filler content of less than 10% by weight, and dimethylvinyl terminated siloxane with dimethylvinyl groups at the terminal. Dimethyl vivyl siloxane having a molecular weight of 5,000 to 100,000 with a content of silica filler of less than 10% by weight was mixed in a methylhydrogen siloxane equivalent ratio.

When the above silicon raw materials were mixed, the silicon raw material and water (H ₂ O) were added in a weight ratio of 1: 0.25 (silicon: water) and stirred rapidly at a stirring RPM 3000 or higher.

The mixture was placed in a 5 mm diameter mold and heated at 50 ° C. for 2 hours. Sodium chloride (NaCl) having an average particle size of 500 μm was buried three to four times on the surface of the silicon grains.

The silicon grains were heated at 170 ° C. for 3 hours to harden the addition polymerization using a platinum catalyst.

In this way, the average pore size of the inner form structure is 500 µm, the average pore density is about 1.6ea / mm ² , and the average pore size of the outer form structure. size) of 500 μm, the average pore density (pore density) of about 2.8ea / mm ² to produce a silicone sponge beads.

After mixing the double microstructured silicon sponge granules prepared in Examples 1 and 2 in a silicone gel, the mixed filler is filled into a silicon shell pouch to prepare a silicone artificial breast implant, and the prepared silicone artificial breast implant The gel bleeding test for the low molecular weight silicone oil component of the silicone artificial breast implants was tested according to the test method of ASTM F703, an international test standard for artificial breast implants, and as a result, as shown in FIGS. 9 to 11. As described above, the silicone artificial breast implant according to the present invention was able to obtain an excellent effect of significantly reducing the low molecular weight silicone oil outflow compared to the conventional products.

As described above, although the preferred embodiment of the present invention has been described with reference to, the present invention is not limited to the above embodiment, it should be interpreted by the appended claims. In addition, various modifications and variations may be made by those skilled in the art within the equivalent scope of the technical concept of the present invention and the appended claims.

1 is a cross-sectional view showing the structure of a conventional silicone artificial breast implant

Figure 2 is a cross-sectional view showing the structure of the silicone artificial breast implants according to the present invention

Figure 3 is a cross-sectional view of the double microporous structure silicon sponge grains according to the present invention

Figure 4 is an external photograph of the double microporous structure silicon sponge grains according to the present invention

Figure 5 is an enlarged external view of the double microporous structure silicon sponge grains according to the present invention

Figure 6 is a cross-sectional micrograph of the outer open cell foam of the double microporous structure silicon sponge grains according to the present invention

Figure 7 is an enlarged cross-sectional view of the inner closed cell foam of the double microporous structure silicon sponge grains according to the present invention

8 is a cross-sectional micrograph of an internal close form of a silicon sponge grain having a double microporous structure according to the present invention.

9 is data of Old Generation artificial breast Gel-Bleed test result

Figure 10 is the results of artificial breast Gel-Bleed test results according to the present invention

11 is a comparative graph of the Breast-Beled artificial breast according to the Old Generation and the present invention

<Explanation of symbols for main parts of drawing>

10a, 10b: silicon bag 20a, 20b: filling

30a, 30b: Junction site 40: Silicon sponge grains with double fine pore structure

50: silicon 60: pore of closed cell structure

70: pore of open cell structure

Claims (6)

In the silicone artificial breast implants inserted into the human body, Silicone breast implants comprising a mixed fill of a silicone gel and a silicone sponge bead of a double microporous structure, and a silicone shell (bag) surrounding the mixed fill The method of claim 1, The silicon sponge (Bead) of the double microporous structure is a silicone artificial breast implant, characterized in that the organosiloxane polymer (Polyorganosiloxane) The method of claim 2, The organosiloxane polymer of the silicon sponge (Bead) is methyl hydrogen siloxane (Methyl hydrogen siloxane) and a platinum catalyst and the silica filler content of less than 10% by weight of dimethylsiloxane (Dimethylsiloxane) of molecular weight 5,000 ~ 100,000 Dimethylvinyl terminated siloxane having a dimethylvinyl group in its terminal group and dimethyl vinyl siloxane having a molecular weight of 5,000 to 100,000 with a silica filler content of less than 10% by weight are mixed and added in an amount equivalent to methylhydrogen siloxane. Silicone artificial breast implants, characterized in that manufactured The method according to any one of claims 1 to 3, The silicon micro-pore structure of the double microporous structure has a form of a closed cell structure, and an outside of a silicon artificial breast, which has a form of an open cell structure. Implant The method of claim 4, wherein The average pore size or cell size of the inner closed cell foam structure of the double microstructured silicon sponge beads is 100 to 700 μm and the average pore size of the outer open cell foam structure. size or Cell size) is a silicone artificial breast implant, characterized in that 100 ~ 700㎛ The method of claim 5, The average pore size or cell size of the inner closed cell foam structure of the double microstructured silicon sponge beads is 200 to 500 μm and the average pore size of the outer open cell foam structure. size or cell size) is a silicone artificial breast implant, characterized in that 200 ~ 500㎛

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