Source: https://patents.google.com/patent/KR101235284B1/en
Timestamp: 2020-01-29 12:03:11
Document Index: 54869998

Matched Legal Cases: ['art 36', 'art 36', 'art 36', 'art 37', 'art 36', 'art 36', 'art 12', 'art 12', 'arts 8', 'art 36', 'art 36', 'art 37']

KR101235284B1 - Silicon artificial breast implants with minimized stress concentration and manufacturing method - Google Patents
Silicon artificial breast implants with minimized stress concentration and manufacturing method Download PDF
KR101235284B1
KR101235284B1 KR1020110061273A KR20110061273A KR101235284B1 KR 101235284 B1 KR101235284 B1 KR 101235284B1 KR 1020110061273 A KR1020110061273 A KR 1020110061273A KR 20110061273 A KR20110061273 A KR 20110061273A KR 101235284 B1 KR101235284 B1 KR 101235284B1
KR1020110061273A
KR20130006789A (en
2011-06-23 Application filed by 유원석 filed Critical 유원석
2011-06-23 Priority to KR1020110061273A priority Critical patent/KR101235284B1/en
2013-01-18 Publication of KR20130006789A publication Critical patent/KR20130006789A/en
2013-02-21 Publication of KR101235284B1 publication Critical patent/KR101235284B1/en
The present invention maximizes the resistance to fatigue rupture by minimizing the stress concentration on the stress received by the implant after insertion of the human body, thereby improving the durability of the implant, and having a thin and beautiful patch-jointed part, the overall feel of the implant is excellent. It is formed on the bottom surface of the silicon shell and the bottom surface of the silicon shell to increase the beauty of the product, and to increase the bonding strength of the patch bonding portion to maximize the bonding durability of the bonding portion, and to maximize the use safety and effectiveness. In the silicone artificial breast implants composed of patch joints to close the holes from the outside, the silicon shells are formed to have a uniform thickness as a whole, and the patch joints are formed to bond the patch to the lower end of the silicon shell with a bonding material. Including the patch ball which becomes the said paddle The patch is bonded to the ball bond portion patch forms a same thickness as the silicon shell, provides a man-made silicone breast implants with minimal stress concentration representing the silicone shell, the same or similar physical properties.
Silicon breast implants with minimized stress concentration and manufacturing method thereof
The present invention relates to artificial breast implants with minimized stress concentration, and to a method of manufacturing the same, more specifically, to form a thickness of the silicon shell and the patch joint portion of the uniform thickness the same as the shell, and the physical properties of the shell and patch junction region It is configured in the same way and is provided with a step part and an uneven groove in the patch joint part so that the patch can be closely bonded inside the shell. After insertion of the human body, the stress concentration phenomenon is minimized against the stress received by the prosthesis. By maximizing the overall durability of the prosthesis, constructing a patch joint with high bonding strength against the pressure acting on the prosthesis, maximizing the joint durability of the joint, and having a thin and beautiful patch joint, the overall feel of the implant is excellent. Of course, by enhancing the beauty of the product, It relates to the concentration of stress, artificial breast implants and a method for manufacturing minimal as possible.
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 saline, hydro-gel, and silicone gels that are filled inside a pouch made of silicone for organ transplantation (hereinafter referred to as "shell", a common term in the art). ), Round type and droplet type depending on the shape, smooth type and rough type depending on the surface condition. Can be summarized as described below.
Saline breast prosthesis is a type of implantable or implantable artificial breast implant that consists of a silicone shell and a valve.
Saline artificial breast implants have the advantage that the volume of the breast can be changed by guaranteeing the safety of the filling in the body after rupture and controlling the amount of saline filling after the use of sterile saline as a filler. The disadvantage is that it is significantly lowered and the shell is less durable.
Hydrogel-filled breast prosthesis is a form of a hydrogel consisting of monosaccharides and polysaccharides inside a shell, such as saline artificial breast implants. This product was developed on the principle of absorption and excretion.
However, hydrogel prosthetic 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. Such hydrogel artificial breast implants are not fully distributed in 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 that of saline artificial breast implants. Sales of artificial breast implants are in a position where sales of silicone artificial breast implants dominate. Silicone gel breast implants were restricted for use by the US Food and Drug Administration (FDA) because of their safety demonstration, but were again officially licensed in 2006.
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 incidence 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.
All of these artificial breast implants are referred to as shells and joints (hereafter referred to as "patch joints"), which is a common term in the art, collectively referred to in the art as blocking the pores that occur during the removal of the shell from the moles. And the filling.
In the case of shells, most of them are manufactured by soaking methods, which have a limit in durability (particularly, fatigue rupture). Basically, the shell manufactured by the immersion method causes a thickness variation between the upper and lower portions of the shell due to gravity, and the thickness variation causes a relatively weak spot due to stress.
In order to increase the durability of the shell in consideration of such fatigue rupture, it is possible to increase the absolute strength to some extent by increasing the overall thickness of the shell, but this also has a limit, the thickness of the lower portion is very much compared to increasing the overall thickness of the shell As the thickening occurs, there is a limit to the flexibility that the breast implants must have. For example, as the thickness of the upper portion of the shell having an average thickness of 1 mm or less increases by 0.3 mm, the thickness of the lower portion may be increased by about 1 mm, and the thickness deviation is further increased.
In addition, the patch bonding part is used for the patch (additional bonding material) and the bonding material used for bonding, in the manufacture of artificial breasts, the patch used as the bonding material for the patch bonding site is the same thickness and the same physical properties as the shell Use materials that represent them.
Because the patch must be made in the form of a multi-layered sheet containing an anti-spill layer of low molecular silicon inside the patch to prevent the patch from degrading in strength. However, it is because it is very difficult commercially and technically to manufacture a patch of a thinner film than the shell while including the barrier layer therein. Therefore, in the art, a part of the shell is usually cut off and used as the patch.
That is, the conventional implant uses a patch 6 having the same thickness as the thickness (average thickness 0.5 to 1 mm) of the silicon shells 5 and 7, as shown in FIG. Losing patch joints (8a, 8b) is very thick and there is a problem that the stretch characteristics of the patch joints are almost disappeared, also, as shown in (b) of Figure 1 when the patch portion of the central portion Since it becomes thinner than the peripheral part, stress concentration occurs due to the difference in physical properties between the silicon shell 7 and the boundary areas of the patch joints 8a and 8b, which causes problems in the durability of the patch 6 in fatigue. Because of this, even in clinical results, the rupture around the patch of the prosthetic breast implants is very frequent.
As a prior art for such patch joints, USP 6074421 describes patch joints of artificial breast implants in which joint lines are not visible. The feature of this technique is a patch joining technique of a patch joining portion having a structure as shown in FIG. 1 (b), and the patch 6 is formed by inclining an edge in the hole of the shell 7 at the portion where the patch 6 joins. The articulation of artificial breast implants, which can give aesthetic appearance as the joint lines between the shell 7 and the patch 6 are not visible by bonding, is described.
However, the above-described prior art focuses only on the improvement of the appearance of the artificial breast implant, and the consideration of the performance improvement part of the entire implant including durability is insufficient. Therefore, the prosthesis may be beautiful in appearance, but since the patch has the same thickness as the shell, part of the patch joint is very thick and thin at the center of the patch joint, whereby the patch joint and the patch joint are thinner. The stretch and tensile properties between the silicone shells are different from each other, and stress concentration occurs due to the difference in physical properties between the shell and the junction area, which has problems in durability against fatigue. Is the same as
In addition, EP 0872221A1, which describes a patch-joining portion of an artificial breast implant in which a seam is not visible, is basically included in the description of FIG. An additional technique for the implantation of artificial breast implant patches, which is characterized as In the prior art, a layer as shown in the drawing is formed on the outer side of the shell 7 around the hole to be patch-bonded, and then the patch 6 is bonded to the portion, whereby the joint line between the shell 7 and the patch 6 is joined. This invisibility refers to artificial breast implants that can give a cosmetic appearance.
However, in the above-described configuration, the overlapping portions 8a and 8b between the shell 7 and the patch 6, such as the patch joint portion of FIG. As in (a) of FIG. 2, the technique is similar to the prior art, and the center portion of the patch junction portion is thinner than the peripheral portion, and therefore, due to the difference in physical properties between the other patch junction region and the silicone shell, As stress concentration occurs, it is the same as other existing artificial breast manufacturing technology which has a problem in durability against fatigue.
In addition, as shown in (a) of FIG. 2, as the joint between the patch 6 and the hole constituting an inclined cross section is not made on the outer side of the shell 7, which is a visible part of the user, Since it is substantially the structure where the seam between the shell 7 and the patch 6 is actually seen, it is difficult to achieve the purpose in the art.
In addition, as shown in (b) of Figure 2, the direction of the pressure received by the patch bonding portion located on the back of the artificial implant according to the main pressure received by the user's movement or activity after insertion of the artificial implant implant It is the same as the arrow direction of (a) and (b) of FIG.
The bonding structure of the above technique is a structure in which a hole is blocked from the outside, and as seen in FIG. It is an easy structure. In addition, the joint structure of this technology concentrates the pressure applied to the implant according to the user's movement after implantation of the implant in a smaller area than the pressure at the site where the patch is bonded. Compared with the patch joint structure that distributes the pressure, there is a structural problem that the durability is weak. Therefore, it is obvious that the bonding structure having a more mechanically and physically stronger and superior bonding durability against the pressure applied to the prosthesis after insertion of the human body is a structure in which a patch is bonded from the inside by placing a layer or a step inside the shell.
However, the formation of layers or steps in the shell to bond the patches without tolerances is very technical and commercially difficult in itself, and the technique of forming layers or steps in the interior of the shell and bonding the patches inside the shell without tolerances to the patches. This is because the above mentioned technique is difficult to compare in terms of difficulty in forming a layer or step on the outside of the shell and patch bonding from the outside without tolerance.
In addition, the prior art described above is not a technology that initially solves the physical characteristics and durability of the product and its components, but is a technology limited only in terms of improving the product outward. Technical considerations regarding the durability of the entire implant, including the pressure applied to the joint structure according to the movement after implantation of the implant and the bonding durability thereto, are insufficient.
In the related art, as shown in the enlarged portion of FIG. 2A, a gap or a crack 12 occurs in the junction boundary point 13 of the joint between the shell 7 and the patch 6.
This is because in the prior art or the current commercially available technology, the bonding material 11 used in the process of bonding the already-cured silicone shell and a patch piece having a certain thickness to be cured together is very high in viscosity. This is because liquid silicone rubber (LSR) or silicone gum (gum) can only be used. In other words, in the process of bonding the patch pieces to the configured layer or the step so that the edges formed in the shell fit the angular layer or the step, the high-viscosity liquid silicone or silicon gum bonding material 11 or the bonding material 11 has a high viscosity. This is because only the bottom portion is not applied to the side portions of the patch pieces, so that the shell and the side portions of the patch pieces have a limitation in that they cannot be bonded to each other.
It is clear that such gaps or cracks are vulnerable in terms of durability for breast implants that are implanted in a patient and placed in a high stress and fatigue environment.
As described above, the prior art bonding structure is a technology focused only on the appearance improvement of the artificial breast implant, and consideration of physical performance improvement including bonding durability and overall durability of the implant is very poor.
In addition, in order to inject the filling material into the shell, the needle is injected through a separate injection device to inject the filling material, and after the filling of the filling material is completed, the needle is removed. At this time, in the process of removing the needle is formed a hole of a fine size (hereinafter referred to as "inlet"), conventionally, as shown in Figure 3 (a), the injection hole generated after injecting the filling material (3) To prevent the leakage of the filling material by using a sealing silicone (4) such as a silicone solution or a silicon gum at the position where the injection hole 3 is formed at the lower part of the patch 6 to prevent the leakage of the filling material from the Alternatively, as shown in (b) of FIG. 3, first, the edge 2 having a ring shape is inserted and a needle is inserted into the center thereof to form a state in which filling material can be injected. It is prevented from leaking the filling material injected into the shell to the outside by blocking with a sealing silicone 4 such as.
However, in the case of the structure and the manufacturing method of blocking the injection hole 3 of the conventional patch, the sealing silicone 4 and its rims applied to block the injection hole 3 protrude outwards, and thus are not aesthetically beautiful. The silicon 4 and its edge portion are rubbed with the outside, whereby there is a problem that can easily detach and fall off.
This phenomenon occurs more frequently when the filling material used for injection is buried in the area where the sealing silicone 4 applied to block the injection hole is applied or applied, and such a phenomenon may occur in the manufacture of artificial breast implants. While filling and hardening of the filling material is almost inevitably occurring, the situation is being solved by wiping the finely leaked filling material and then blocking the inlet (3). However, the inlet is clogged with less filling material leaked due to the carelessness of the worker, so that the silyl silicon (4) blocking the inlet may be easily detached.
As such, the filling material filled in the shell may be leaked to the outside, thereby greatly reducing the quality and safety of the product.
In order to solve this problem, Korean Patent Publication No. 10-2011-0041990 is disclosed. In the related art, as shown in FIG. 4A, the filling material injection groove 9, which is a space for injecting the filling material through the needle into the inner space of the silicon shell, is concave at the center of the lower surface of the patch 6. It is formed in an intaglio shape, and then the filling material injection groove 9 is prevented from leaking by filling the filling material injection groove 9 with a sealing silicone 9a such as a silicone solution or a silicon gum. . This prevents the sealing silicon 9a and its edges applied to block the injection hole from protruding to the outside, thereby preventing detachment of the sealing silicon 9a due to external friction.
However, as mentioned above, the part about the weakening of the bonding strength of the inlet sealing part due to leakage of the filling material remains a problem.
The present invention is to solve the above problems, the thickness of the silicon shell of uniform thickness and the patch bonding portion, which is the joint portion of the shell and the patch is configured to be exactly the same as the shell and the same or similar physical properties (elongation characteristics, Strength, elasticity, etc.), by maximizing the resistance to fatigue rupture by minimizing the stress concentration caused by the difference in the physical properties of the silicone shell and the patch junction, rupture, which is the greatest side effect of artificial breast implants To provide a silicone artificial breast implant and a method of manufacturing the same, which minimizes stress concentration, which significantly lowers the rupture rate for the (upture) and improves safety and effectiveness of use.
In addition, the present invention is to form a patch bonding layer from the inside of the shell which is a structure that is mechanically and physically resistant to the pressure acting on the prosthesis to form the step portion and the uneven groove in the patch bonding portion that is the inner portion of the shell, the shell The present invention provides a silicone artificial breast implant and a method of manufacturing the same by increasing the bonding area of the patch joint portion bonded to the joint and increasing the bonding strength to minimize the stress concentration excellent in the bonding durability of the patch joint region.
In addition, the present invention to provide a silicone artificial breast implants and a method for manufacturing the same to minimize the stress concentration excellent in the durability of the joint to prevent the occurrence of cracks or cracks at the junction boundary between the shell and the patch in the patch junction site will be.
In addition, the present invention provides a silicone artificial implant and a method of manufacturing the same as the overall thickness of the silicone shell including the patch joint portion is very excellent in the overall feel of the implant to minimize the stress concentration of high efficiency and quality of the product It is to.
In addition, the present invention forms an injection hole generated by the injection of the filling material and the silicon sealing material that prevents it, but smoothly double-sealing so that the edge is not exposed to the outside, thereby improving the quality including the beauty of the inlet sealing area The artificial breast implants and the method of manufacturing the same have minimized the stress concentration which can maximize the safety and effectiveness of use as there is no fear that the silicone sealing material of the inlet sealing part will fall because the bonding strength of the inlet sealing part and the durability against fatigue rupture are enhanced. It is to provide.
According to the present invention, a silicone breast implant having a minimal stress concentration is a silicone breast implant including a silicon shell forming an outer wall and a patch bonding portion for closing a hole formed on a lower surface of the silicon shell from the outside. Is formed to have a uniform thickness as a whole, the patch bonding portion includes a patch hole formed to bond the patch to the inner lower end of the silicon shell with a bonding material, the patch is bonded to the inside of the patch hole The junction is formed to have the same thickness as the silicon shell and to exhibit the same or similar physical properties as the silicon shell.
The patch hole is formed on the inner surface of the silicon shell that the patch is in contact with at least one stepped portion is formed and the diameter of the patch hole inside the shell is formed in a structure wider than the diameter of the outer shell.
The patch hole is formed with an inclined surface inclined to form a wider diameter toward the upper side toward the step portion from the bottom.
The patch hole forms a concave rounded curved surface along the outer circumference of the stepped portion.
At least one uneven groove is formed in the stepped portion of the patch hole to increase a bonding area with the patch and to improve joining durability between the patches to prevent detachment of the patch bonding portion.
The concave-convex groove may be formed in a “하” shape having a pointed shape toward the lower side, and the concave-convex groove may be formed in a “∪” shape having a smooth curved shape toward the lower side, and may be formed in an “angular” shape as a whole.
It is also possible to form and configure the shape.
The patch is made of a thin film patch that is mixed with a thin layer of the low-molecular silicon outflow prevention.
The patch bonding portion includes a bonding material or a bonding material which is formed between the silicon shell and the patch to be smoothly bonded.
The patch bonding portion is completely bonded to form the same horizontal plane as the inner bottom surface of the silicon shell at the top of the patch to prevent gaps or cracks at the junction boundary between the shell and the patch and includes at least one thin film patch. It is done by
An injection hole formed on the lower surface of the patch joint portion to inject a filling material into the inner space of the silicon shell, and a filling injection groove formed at a lower side of the injection hole to form a multi-layer structure of two or more stages with a predetermined depth. It is made, including.
The filler injection groove is firstly filled in the lower space of the injection hole to prevent the internal space of the silicon shell from being closed from the outside, and secondly filled in the lower space of the first sealing part. It includes a second sealing portion for finishing the filling material injected into the inner space of the silicon shell to prevent leakage.
The patch bonding portion acts according to the stress acting according to the left and right stretching force when the stress is applied to the junction boundary where the silicon shell and the patch are bonded to each other and the stretching force in the inclination angle direction of the stepped portion or the uneven groove section and in the inclination angle direction of the patch hole cutting cross section. The stress acts simultaneously so that the stress is dispersed at least in the biaxial direction or more.
According to the present invention, there is provided a method for manufacturing a silicone artificial breast implant with minimal stress concentration, comprising: a silicon solution dipping step of dipping a breast-shaped mold in a silicone solution to obtain a silicon shell; A drying and curing step of drying and curing the silicon shell attached to the mold through a drying apparatus to obtain a silicon shell; An artificial breast shell acquiring step of forming a hole in a lower end of the silicon shell attached to the mold to detach the silicon shell from the mold; A patch hole forming step of forming a patch hole including a stepped portion and a concave-convex groove in a layered structure so as to bond the patch on the inner surface of the hole of the silicon shell; A patch structure forming step of forming a patch including a thin film patch and a bonding material according to the layer shape and the shape of the uneven groove, including the perimeter and thickness corresponding to the patch hole so that the patch can be perfectly bonded to the patch hole without tolerances; ; A patch bonding step of bonding the molded thin film patch, the patch structure of the patch and the bonding material onto the patch hole of the silicon shell; A filler injection groove processing step of forming a filler injection groove forming a concave multilayer structure on a lower surface of the patch to inject filler material into the internal space of the silicon shell; A filling step of filling and filling a filling material through an injection hole into an inner space of the silicon shell in which the filling injection groove is formed; A first sealing is made by filling the filler injection groove with double using a sealing material so as to prevent the filling material filled in the inside of the silicon shell from flowing out from the injection hole, which is a fine hole by the needle generated by filling the filling material, to the outside. It comprises a; finishing step of forming the part and the second sealing part in order.
According to the silicone artificial breast implant with minimized stress concentration according to the present invention and a method of manufacturing the same, the thickness of the silicon shell and the patch joint portion having a uniform thickness is configured to be exactly the same as that of the silicon shell, and the same or similar physical properties as the silicon shell ( The maximum side effects of artificial breast implants by maximizing the resistance to fatigue rupture by minimizing the stress concentration caused by the difference in the physical properties of the silicone shell and the patch joint by constructing a patch joint site having elongation characteristics, strength, elasticity, etc. Significantly lowers the rate of rupture for phosphorus rupture, thereby maximizing the safety and effectiveness of use.
In addition, the silicone artificial breast implants minimized stress concentration according to the present invention and a method of manufacturing the patch joint portion includes a stepped portion and uneven groove structure, mechanical and physically strong structure against the pressure acting on the implants It consists of a bonding structure in which a patch bonding layer is formed from the inside of the phosphorus silicon shell, and this bonding structure is configured to disperse stress in two or more directions along with an increase in the bonding area, thereby improving mechanical and physical bonding strength. In addition, there is an effect of improving the joining durability of the joint and, in turn, the overall safety of the prosthesis.
In addition, the silicone artificial breast implant with minimized stress concentration according to the present invention and a method of manufacturing the same prevents the occurrence of cracks or cracks at the junction boundary point between the silicon shell and the patch at the patch joint, thereby improving the joint durability of the joint. It can be effected.
In addition, the silicone artificial breast implant with minimized stress concentration according to the present invention and its manufacturing method is the same thickness of the silicon shell including the patch and the patch joint portion, so the overall feel of the implant is very excellent and the effectiveness of the product There is an effect to increase the quality.
In addition, the silicone artificial breast implants with minimized stress concentration according to the present invention and a method for manufacturing the same are finished by smoothly double-sealing so that the injection hole generated by the injection of the filling material and the silicone sealing material or the edge preventing the same are not exposed to the outside. Since the treatment is performed, there is an effect of improving the quality of the sealing portion of the injection port.
In addition, the silicone artificial breast implants with minimized stress concentration according to the present invention and a method for manufacturing the same are due to the structure of the filling injection groove formed in a multi-layer, the bonding area of the sealing area is widened, the sealing silicone used for the injection port sealing and its corners Since the part does not rub against the outside, the bonding strength of the inlet sealing portion and the durability against fatigue rupture are improved, so that there is no fear that the sealing silicone of the inlet sealing portion may fall, so that the safety of the fillings may be improved.
In addition, the artificial artificial breast implants and the method of manufacturing the same according to the present invention minimize the stress concentration by forming a structure of the filler injection groove formed in a multi-layer and configured to block the injection hole in the double, to the injection hole in the process of filling the filling material It is possible to prevent the phenomenon of weakening of the bonding force of the inlet sealing part due to the finely leaked filler, to compensate for the problems caused by the operator's mistakes, and to maximize the safety against leakage of the filler.
Figure 1 (a), (b) is an exemplary view showing the silicon shell and patch joint portion of the conventional artificial breast implants, respectively.
Figure 2 (a), (b) is an exemplary view showing another form of the silicone shell and patch joint portion of the conventional artificial breast implants, respectively.
Figure 3 (a), (b) is an exemplary view showing the finishing treatment of the patch joint portion of the conventional implant, respectively.
Figure 4 (a), (b) is an exemplary view showing a different form in the finishing treatment of the patch joint portion of the conventional implant, respectively.
5 is a cross-sectional view showing the artificial breast implants according to an embodiment of the present invention.
Figure 6 is an enlarged cross-sectional view showing a patch bonding portion in one embodiment of the present invention.
Figure 7 is an enlarged cross-sectional view showing another embodiment of the patch bonding portion in the present invention.
Figure 8 (a), (b) is an enlarged cross-sectional view showing another embodiment of the uneven groove of the patch joint portion in the present invention, respectively.
Figure 9 is an enlarged cross-sectional view showing a state before the sealing material finishing treatment of the filler injection groove according to the embodiment of the present invention.
Figure 10 (a), (b) is an enlarged cross-sectional view showing a state after the sealing material finishing treatment of the filler injection groove according to the patch in the present invention, respectively.
11 is a flowchart illustrating a method of manufacturing an artificial breast implant according to an embodiment of the present invention.
The present invention provides a silicone breast implant including a silicon shell forming an outer wall and a patch bonding portion for closing a hole formed on the bottom surface of the silicon shell from the outside, wherein the silicon shell is formed to have a uniform thickness as a whole. The bonding portion includes a patch hole formed to bond the patch to the inner lower end of the silicon shell with a bonding material, wherein the patch bonding portion in which the patch is bonded to the inside of the patch hole forms the same thickness as the silicon shell. Silicon artificial breast implants that minimize stress concentrations exhibiting the same or similar physical properties as those of the silicon shell are characterized by a technical configuration.
In addition, the patch hole is a silicone artificial breast implant that minimizes the stress concentration formed by forming a layer on the inner surface of the silicon shell that the patch is in contact with at least one step is characterized by a technical configuration.
In addition, the patch hole is characterized in that the silicone artificial breast implants to minimize the stress concentration is formed in a structure in which the diameter of the patch hole inside the shell is wider than the diameter of the shell outer side.
In addition, the patch hole features a silicone artificial breast implant that minimizes stress concentration to form an inclined surface inclined to form an increasingly wider diameter from the lower side toward the step portion.
In addition, the patch hole is characterized by a silicone artificial breast implant that minimizes the stress concentration to form a concave rounded curved surface along the outer circumference of the step portion.
In addition, at least one uneven groove is formed in the stepped portion of the patch hole to increase the bonding area with the patch and improve joining durability between the patches to prevent detachment of the patch bonding portion. Silicon breast implants with minimal stress concentration are a feature of the technology.
In addition, the patch bonding portion is at least one thin film patch that is completely bonded and formed to form the same horizontal plane as the inner lower surface of the silicon shell at the top of the patch to prevent gaps or cracks at the junction boundary between the shell and the patch. Silicon artificial breast implants with minimized stress concentration as described above are characterized by the technical configuration.
In addition, the patch bonding portion is an injection hole formed on the lower surface so as to inject the filling material into the internal space of the silicon shell, the filling material is formed in the concave formed in a multi-layer structure of two or more stages at a predetermined depth located below the injection hole. Silicon artificial breast implants with minimized stress concentration including injection grooves are characterized by technical configuration.
In addition, the filler injection groove is firstly filled in the lower space of the injection hole to prevent the internal space of the silicon shell to be closed from the outside and secondly filled in the lower space of the first sealing portion The technical features of the silicone artificial breast implants are minimized the stress concentration including a second sealing portion to prevent the filling material injected into the interior space of the silicon shell to leak out.
In addition, the patch joint portion has a stress acting according to the left and right stretching force when the stress is applied to the junction boundary point where the silicon shell and the patch are bonded to each other, and the stretching force in the inclination angle direction of the stepped portion or the uneven groove section and in the inclination angle direction of the patch hole cutting cross section. The silicone artificial breast implant that minimizes the stress concentration at which the stress acting simultaneously acts and distributes the stress in at least biaxial direction is characterized by the technical configuration.
In addition, the present invention provides a method for manufacturing a silicone artificial breast implant, comprising: a silicon solution dipping step of dipping a breast-shaped mold in a silicone solution to obtain a silicon shell; A drying and curing step of drying and curing the silicon shell attached to the mold through a drying apparatus to obtain a silicon shell; An artificial breast shell acquiring step of forming a hole in a lower end of the silicon shell attached to the mold to detach the silicon shell from the mold; A patch hole forming step of forming a patch hole including a stepped portion and a concave-convex groove in a layered structure so as to bond the patch on the inner surface of the hole of the silicon shell; A patch structure forming step of forming a patch including a thin film patch and a bonding material according to the layer shape and the shape of the uneven groove, including the perimeter and thickness corresponding to the patch hole so that the patch can be perfectly bonded to the patch hole without tolerances; ; A patch bonding step of bonding the molded thin film patch, the patch structure of the patch and the bonding material onto the patch hole of the silicon shell; A filler injection groove processing step of forming a filler injection groove forming a concave multilayer structure on a lower surface of the patch to inject filler material into the internal space of the silicon shell; A filling step of filling and filling a filling material through an injection hole into an inner space of the silicon shell in which the filling injection groove is formed; A first sealing is made by filling the filler injection groove with double using a sealing material so as to prevent the filling material filled in the inside of the silicon shell from flowing out from the injection hole, which is a fine hole by the needle generated by filling the filling material, to the outside. The method of manufacturing a silicone artificial breast implant with minimized stress concentration, comprising: a finishing treatment step of forming the parts and the second sealing part in order.
Next, a preferred embodiment of the silicone artificial breast implant with minimized stress concentration according to the present invention and a manufacturing method thereof will be described in detail with reference to the accompanying drawings.
However, embodiments of the present invention may be modified in many different forms, the scope of the invention is not to be construed as limited to the embodiments described below. Embodiments of the present invention are provided to explain those skilled in the art to understand the present invention, the shape of the elements shown in the drawings and the like are shown by way of example in order to emphasize more clear description.
First, as shown in FIGS. 5 to 10, one embodiment of a silicon artificial breast implant with minimized stress concentration according to the present invention is formed on the silicon shell 10 and the lower surface of the silicon shell 10 forming an outer wall. In the silicon artificial breast implant (I) consisting of a patch bonding portion (P) for closing the formed hole from the outside, the silicon shell 10 and the silicone shell (10) to constitute the patch bonding portion (P) It consists of a patch 20 and a patch hole (11).
In forming the silicon shell 10 having a uniform thickness, the silicon shell 10 is shaped by using a mold (not shown) in the manufacturing process of forming the silicon shell 10, and after the silicon shell 10 is formed, For removing the mold from the silicon shell 10, a hole is formed in the lower surface of the silicon shell 10, and the patch hole 11, which is a portion where the silicon shell 10 and the patch 20 are bonded, is formed. To form.
The silicon shell 10 is formed to have a uniform thickness as a whole.
The thickness of the silicon shell 10 can be formed by various adjustments, but in consideration of safety and efficiency, it is preferable to form the thickness of 0.5 ~ 2mm.
The patch bonding portion (P) is to close the inside of the silicon shell 10 from the outside, the patch hole 11 from the outside to maintain a state in which the filler is filled in the inside of the silicon shell (10) It is formed to close.
The patch hole 11 forms a frame of the patch bonding portion P and is a portion to which the patch 20 is bonded. The patch hole 11 is formed to bond the patch 20 to the lower end of the silicon shell 10 with a bonding material. do.
5 and 6, the patch hole 11 is formed on the inner surface of the silicon shell 10 in contact with the patch 20 to form at least one stepped portion 12.
The patch hole 11 is formed in a structure in which the hole diameter of the upper portion of the patch hole 11 is larger than the diameter of the lower hole of the patch hole 11 because the step portion 12 is formed.
The stepped portion 12 may be formed by adjusting the height in various ways. Preferably considering the preferred total thickness of the silicon shell 10 is 0.5 ~ 2mm, it is preferable to form the height of the stepped portion 12 to 0.25 ~ 1.5mm.
The patch hole 11 is formed with an inclined surface 16 inclined to form an increasingly wider diameter from the lower toward the step portion 12 toward the upper side. That is, the inclined surface 16 is formed to be inclined at an inclination angle of 45 ° or less with respect to the horizontal line of the lower surface of the silicon shell 10 as shown in FIG.
The patch hole 11 forms a concave rounded curved surface 15 along the outer circumference of the step portion 12. That is, the curved surface 15 is formed at a position connected to the inner surface of the silicon shell 10 from the outer end of the step portion 12.
In addition, as shown in Fig. 7, the stepped portion 12 can be configured in a structure in which a plurality of layers, that is, a multilayer, are formed in the patch hole 11. Specifically, the stepped portion 12 may be configured to form a plurality of layers with a fine and uniform height from one side of the inclined surface 16 to one side of the curved surface 15.
As shown in FIG. 6, the stepped portion 12 of the patch hole 11 is formed with an uneven groove 13 formed at a minute depth on a surface where the patch 20 is in contact with the patch hole 11.
The uneven groove 13 is formed at least one at regular intervals, specifically, the uneven groove 13 is the curved surface 15 in the inclined surface 16 on the step portion 12 It is preferable to form in a form in which the interval becomes narrower toward the direction toward.
The uneven groove 13 may form a groove having a predetermined depth, but may be formed as a “∨” shaped groove having a pointed downward shape, and the uneven groove 13 is downward as shown in FIG. 8A. It is also possible to form a "curve" groove with a gentle curved surface.
In addition, the uneven groove 13 is angled to maintain a deeper bond with the patch 20 on the curved surface 15, which is the end of the step portion 12, as shown in (b) of FIG. Form “
It is also possible to form a 'groove'.
By forming the uneven groove 13 in the stepped portion 12 of the patch hole 11 as described above, the bonding area with the patch 20 in the silicon shell 10 is increased and the joining durability is mutually increased. As a result, it is possible to prevent the detachment phenomenon of the patch bonding portion P.
The patch joint portion P, to which the patch 20 is bonded to the patch hole 11, has the same thickness as that of the silicon shell 10, and exhibits the same or similar physical properties as the silicon shell 10. Is done.
The patch 20 is formed to be bonded to form a thickness and size corresponding to the patch hole 11, the low-molecular silicon in the patch 20 to prevent degradation of the physical properties by the filler (not shown in the figure) Spill prevention layer (not shown in the figure) is mixed.
The patch bonding portion P, that is, the bonding structure of the silicon shell 10 and the patch 20 has a structure in which a gap or crack does not occur at the bonding boundary point bonded to each other.
The patch bonding portion P is formed between the silicon shell 10 and the patch 20 to form a bonding material or a bonding material so as to be smoothly bonded.
The patch joint portion (P) is a patch joint of a structure that is mechanically and physically resistant to pressure acting on the implant (I) to prevent gaps or cracks at the junction boundary point between the shell 10 and the patch 20 At least one thin film patch 28 is formed to be completely bonded and thinly formed so as to form a layer so as to form the same horizontal plane as the inner bottom surface of the silicon shell 10 at the top of the patch 20.
The thin film patch 28 may be formed to have a fine thickness, but may be formed by adjusting the thickness in various ways. Preferably, the thickness of the thin film patch 28 is preferably formed to 200㎛ or less, based on the preferred thickness of the silicon shell 10 and the patch bonding portion (P) is 0.5 ~ 2mm.
In the present invention, the overall configuration uses 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. A polymer in which these monomers are polymerized by being substituted with (Tri-fluoro propyl siloxane) may be used, and a copolymer using an oligomer made of the monomers may also be used.
In particular, the thin film patch 28 uses a structurally stable silicone polymer having high molecular orientation and compactness of the silicone polymer and high bonding strength between the polymers, so that the low molecular weight silicone oil molecules (filling material) are physically and chemically A barrier film that forms a silicone elastomer that is difficult to pass through is laminated on an intermediate layer of the silicon polymer layer of the thin film patch 28. In addition, the thickness of the barrier film can be variously adjusted for the blocking effect, in consideration of safety and efficiency, the thickness is preferably formed to 10 ~ 80㎛.
For example, when the material of the thin film patch 28 is used as a polymer in which diphenylpolysiloxane and dimethylpolysiloxane are polymerized, the barrier film laminated on the intermediate layer of the thin film patch 28 may be methyl 3,3,3-trifluoropropylpolysiloxane or Silicone elastomers in which diphenylpolysiloxane and dimethylpolysiloxane are polymerized may be used.
As shown in FIG. 9, the patch bonding portion P has an injection hole 21 formed on the lower surface to inject a filling material into the internal space of the silicon shell 10, and the injection hole 21 of the injection hole 21. It consists of a filling injection groove 25 is formed in the form of a concave intaglio and formed in a multi-layered structure of two or more stages at a lower depth. In more detail, the filler injection groove 25 is formed on the lower surface of the patch 20 to be concave into a multilayer by a predetermined depth is formed first, to the upper side of the filler injection groove 25 The injection hole 21 is formed as a space generated by stabbing a separate injection device when the filling material is injected to form a structure in communication with the internal space of the silicon shell 10.
The depth of the filling injection groove 25 can be formed by various adjustments, but is preferably formed in 0.3 ~ 1.5㎜ in consideration of the efficiency.
As shown in FIG. 10, the filler injection groove 25 injects a filler material into the silicon shell 10 and then closes the opened injection hole 21 to prevent the filler material from leaking to the outside. By performing the role of, it comprises a first sealing portion 36 and the second sealing portion 37 formed of a sealing material.
Since the first sealing part 36 is primarily sealed in the lower space of the injection hole 21 of the filler injection groove 25, the first sealing part 36 is closed to close the internal space of the silicon shell 10 from the outside. . That is, the first sealing part 36 fills the filling material in the inside of the silicon shell 10 and then fills the injection hole 25 by the pressure applied to the implant I in the process of filling the filling injection groove 25. 21) prevents the sealing material from leaking out of the sealing material and prevents the sealing phenomenon, and the sealing process is insufficient due to an operator's mistake such as less wiping of the filling material buried in the inlet 21 after filling the filling material. To prevent it.
The sealing material constituting the first sealing portion 36 may be formed in the form of a liquid silicone (LSR: Liquid Silicone Rubber) having a low viscosity that can be sealed without pressurizing the filler injection groove 25, that is, a relatively low viscosity. Specifically, it is preferable to form the viscosity of the first sealing portion 36 in the range of 100 to 2,000 cps in consideration of safety and efficiency.
Since the second sealing portion 37 is secondly filled in the lower space of the first sealing portion 36 and sealed, a final finish is performed so that the filling material injected into the internal space of the silicon shell 10 does not leak out. Process. That is, the second sealing part 37 is to more firmly double the filling injection groove 25 blocked by the first sealing part 36, and already implanted by the first sealing part 36 Since the filling material does not leak from the pressure applied to (I) toward the inlet 21, it is possible to apply the pressure on the filling injection groove 25 again to form and bond smoothly.
Sealing material constituting the second sealing portion 37 may be used in the form of silicon gum (liquid gum) or liquid silicone (LSR) that can be molded and bonded by pressing on the filler injection groove (25). Preferably, the sealing material of the silicon gum form is formed.
Here, the silicon polymer material mentioned in the present invention is used so that the silicon shell 10 and the patch junction P may have the same thickness and the same physical properties, but the thin film patch 28 and the bonding material may be used. The patch 20 may include a silicon material having a different physical property from that of the silicon shell 10. This is to make the physical properties of the bonded structure composed of the thin film patch 28 and the patch 20 including the bonding material to be the same as the physical properties of the silicon shell 10, which is a blocking film provided inside the silicon shell 10 And the difference in thickness between the barrier film formed in the thin film patch 28 or the property difference due to the bonded structure itself.
Bonding material constituting the patch joint portion P by bonding the thin film patch 28 to the patch 20 or the patch 20 to the silicon shell 10 is one of the silicon raw materials mentioned in the present invention. Alternatively, a gum type silicone bonding material or a liquid type silicone (LSR: Liquid Silicone Rubber) bonding material may be used.
When the stress is applied to the junction boundary point at which the silicon shell 10 and the patch 20 are bonded to each other, the patch joint portion P acts according to the left and right stretching force and the stepped portion 12 or the uneven groove 13. The stress acting according to the stretching force in the inclination angle direction of the cross section and the inclination angle of the cutting hole cutting cross section simultaneously acts to disperse the stress in at least two axes. In more detail, when looking at the stress acting on the joint structure between the components constituting the patch joint (P), the stress of the junction boundary is the stress (horizontal direction) acting in the horizontal direction according to the left and right stretching force, Stress (inclination direction) acting according to the stretching force in the inclined plane direction of the cross-sectional inclination angle of the patch hole 11 formed in the silicon shell 10 and the stepped portion 12 or the uneven groove 13 formed in the patch hole 11 The patch (slope direction) acting according to the inclined angular stretching force of the cross section, or the stress (vertical direction) acting according to the vertical stretching force of the cross section 12 simultaneously acts simultaneously so that the stress is distributed in two or more directions. Bonding structure has the same effect as that of the integral silicon shell 10 and forms a structure having durability against stress.
Next will be described a manufacturing method for producing a silicone artificial breast implant with a minimum stress concentration according to the present invention configured as described above.
First, as shown in FIG. 11, an embodiment of a method for manufacturing a silicone artificial breast implant with minimized stress concentration according to the present invention, in the method for manufacturing a silicone artificial breast implant, silicon solution immersion step (S10), and drying and curing Step (S20), artificial breast shell acquisition step (S30), patch pore forming step (S40), patch structure forming step (S50), patch bonding step (S60), filler injection groove processing step (S70) And, it comprises a filling step (S80), and finishing treatment (S90).
In the silicon solution dipping step (S10), the breast-shaped mold is immersed into a container containing the silicon solution to obtain the silicon shell 10 of the first artificial breast so that the silicon solution is buried on the entire surface of the mold.
In the drying and curing step (S20) to obtain the silicon shell 10 to form the artificial breast implant (I) by drying and curing the mold contained in the silicone solution. That is, the silicon shell 10 is dried inside the drying apparatus to obtain the silicon shell 10, and then dried and cured.
In the artificial breast shell acquiring step (S30), a hole is formed in the lower end of the silicon shell 10 attached to the mold to remove and obtain the silicon shell 10 from the mold.
In the patch hole forming step (S40), a patch hole 11, which is a portion for bonding the patch 20 to the inner side of the lower end hole of the obtained silicon shell 10, is formed. That is, the stepped portion 12 having a layered structure is formed on the inner surface of the lower end hole of the silicon shell 10 so as to bond the patch 20 to the inner surface, and the plurality of stepped portions 12 are formed on the inner surface of the silicon shell 10. To form the uneven groove 13.
In forming the stepped portion 12 and the uneven groove 13 in the silicon shell 10, the silicon shell 10 is inverted using the patch hole 11 formed in the silicon shell 10. The inner surface of the silicon shell 10 is placed outside, and the silicon shell 10 is mounted on a separate jig, and then the stepped part 12 is processed, and then the uneven groove (on the stepped part 12) is formed. 13) process.
In the patch hole forming step (S40) through a method of mechanically etching the step portion 12 and the concave-convex groove 13 which is a space to be bonded to the patch 20 on the lower surface of the silicon shell 10. It is possible to form.
In addition, in the patch hole forming step (S40), a method of chemically etching the stepped portion 12 and the uneven groove 13 which is a space to which the patch 20 can be bonded on the lower surface of the silicon shell 10. It is also possible to form through, and is formed through the method of laser processing the step portion 12 and the uneven groove 13 which is a space to which the patch 20 can be bonded on the lower surface of the silicon shell 10. It is also possible.
In the patch structure forming step (S50), the thin film patch so that the patch 20 including the thin film patch 28 to the patch hole 11 of the silicon shell 10 can be completely bonded without a tolerance. 28) and patch 20 including the bonding material according to the shape and the shape of the patch hole 11 having the stepped portion and the uneven groove 13, including the circumference and thickness corresponding to the patch hole 11 The structure is molded.
In the patch structure forming step (S50), the patch 20 including the thin film patch 28 and the bonding material corresponds to the shape, circumference and thickness of the stepped portion 12 and the uneven groove 13 of the patch hole 11. It is put into a molding die and processed through a method of press compression molding.
In the patch bonding step (S60), the patch structure is bonded onto the patch hole 11 of the silicon shell 10.
Joining the patch structure formed in the patch structure forming step (S50) to the patch hole 11 of the silicon shell 10, the stepped portion 12 and the uneven groove 13 formed in the patch hole 11 ) Is inverted so as to be positioned inside the silicon shell 10, and then the patch structure is exactly matched to the patch hole 11 inside the silicon shell 10, and then press-pressed and heated to join.
When the patch bonding portion P is formed in the patch hole 11 of the silicon shell 10, a silicon bonding device such as a press is generally used, and the configuration and operation principle of the silicon bonding device can be easily understood by those skilled in the art. As it is understood, detailed description thereof will be omitted.
In this case, the patch bonding portion (P) formed in the patch bonding step (S60) has the same thickness as the silicon shell 10, and has the same physical properties as the silicon shell 10, the silicon shell 10 ) And the fatigue durability of the entire implant (I) is improved by minimizing the stress concentration caused by the difference in physical properties appearing in the patch junction (P). In addition, the patch bonding structure of the patch bonding portion (P) is a structure in which no gap or crack occurs in the corner portion of the junction boundary point where the silicon shell 10 and the patch 20 are bonded, the stepped portion 12 And a joint structure including a structure of the uneven groove 13, the joint area of which is increased, and the patch 20 including the thin film patch 28 is bonded from the inside of the silicon shell 10. ) To better disperse the stress and to form a structure that is mechanically and physically resistant to the pressure acting on the implant (I) to achieve a structure that improves the bonding durability of the patch joint (P).
On the other hand, in the conventional patch bonding structure, as shown in (a) and (b) of FIG. 1, the thickness of the patch bonding portions 8a and 8b is 1.3 to 3 mm, whereas the thickness of the silicon shell 7 is 0.5 to 1 mm on average. And the thickness of the bonded center portion is 0.3 to 0.8 mm, the difference in physical properties between the silicon shell 7 and the patch bonding portions 8a and 8b is remarkable, and much stress is concentrated at the boundary between the silicon shell 7 and the bonding portion. It is a structure with a weak site for. Alternatively, as shown in FIG. 2A, the thickness 7 of the silicon shell is 0.5 to 1 mm on the average, whereas the thickness of the center portion bonded to the silicon shell is 0.3 to 0.8 mm, so that the patch is bonded to the silicon shell 7. The difference in physical properties of the parts 8a and 8b is remarkable, so that a lot of stress is concentrated at the boundary between the silicon shell 7 and the joint part, and thus the structure has a weak part against fatigue. Alternatively, as shown in FIGS. 2A and 2B, a gap or crack 12 occurs in the junction boundary 13 of the junction between the silicon shell 7 and the patch 6, or the silicon shell It consists of a patch joining structure in which the joining durability is reduced because it is vulnerable to the pressure which a prosthesis receives by patch joining from the outer side of (7).
However, the structure of the patch bonding portion P of the present invention has a structure of the patch bonding portion P composed of the same thickness and physical properties as the silicon shell 10, and thus has a very strong response to stress. Therefore, the patch joint portion P of the present invention has a high durability because the thickness of the patch joint portion (P) is thin but rather strong with strong bonding strength, and improves the overall durability of the implant (I) ( It is possible to achieve the structure of P).
In the filling injection groove processing step (S70) to the inner surface of the silicon shell 10 to insert the filling material through a separate injection device to the needle of the injection device in the lower surface of the patch 20 The filler injection groove 25 forming a concave multilayer structure is formed.
In forming the filling injection groove 25 is formed in the shape of the filling injection groove 25 is embossed and the protruding molding plate (not shown in the drawing) to take the center of the lower surface of the patch 20 It is possible to compression molding so that the filler injection groove 25 is formed.
In addition, the filler injection groove processing step (S70) may be formed by a laser processing method so that the filler injection groove 25 is formed concave, mechanically etched so that the filler injection groove 25 is formed concave. It is also possible to form through the method, it is also possible to form concave through the method of chemically etching the filler injection groove (25).
In forming the filler injection groove 25 through the laser processing, it is also possible to form the filler injection groove 25 in multiple stages by irradiating a laser beam, which is a high-density heat source, under the patch 20. It is also possible to process the filler injection groove 25 by laser sanding on the lower surface of the patch 20.
In the filling step (S80), the filling material is injected into the internal space of the silicon shell 10 from the patch 20 in which the filling injection groove 25 is formed through the injection hole 21 to fill.
The injection hole 21 may be formed in the process of forming the filler injection groove 25 from the filler injection groove processing step (S70), injecting the injection material through the injection device from the filling step (S80) It is also possible to form naturally in the process.
In the finishing step (S90) to prevent the filling material filled in the inside of the silicon shell 10 from the inlet 21 which is a fine hole by the needle generated by filling the filling material to prevent the outflow to the outside Filling injection groove 25 is very much using the sealing material.
In filling the filling injection groove 25 so as to close the injection port 21, the first sealing part 36 is formed through a sealing material having a low viscosity, and then the pad is added to the first sealing part 36. The second sealing portion 37 is formed in the remaining space of the filler injection groove 25 so as to form a second sealing portion, thereby completely doubled.
As such, the first sealing portion 36 and the second sealing portion 37 formed in the finishing treatment step (S90) have a large bonding area of the sealing portion due to the structure of the filler injection groove 25 formed in multiple layers. Since the sealing silicone used to seal the injection hole 21 and its edge portion do not rub against the outside, the bonding force of the injection hole 21 and the durability against fatigue rupture are improved, thereby sealing the injection hole 21. Since there is no fear that the sealing silicone of the site will fall, there is an effect of more safety against leakage of the filler. In addition, by filling the structure of the filler injection groove 25 formed in a multi-layer and using the same to block the injection port 21 in two, the filling finely leaked into the injection hole portion 21 generated in the filling process of the filling material. Due to this, it is possible to prevent the bonding force of the sealing portion of the injection hole 21 from being weakened, and to compensate for the problems caused by the mistake of the operator, thereby increasing safety against leakage of the filler.
That is, according to the silicon artificial breast implants and the method of manufacturing the same to minimize the stress concentration according to the present invention configured as described above, the thickness of the junction portion of the silicon shell and the patch of uniform thickness and the silicon shell completely the same Maximizes the resistance to fatigue rupture by minimizing the stress concentration caused by the difference in the physical properties of the silicone shell and patch joints, as it consists of patch joints having the same or similar physical properties (extension characteristics, strength, elasticity, etc.). Therefore, it is possible to maximize the use safety and effectiveness by significantly lowering the rupture rate for rupture, which is the biggest side effect of artificial breast implants.
In addition, the present invention includes a structure in which a stepped portion and a concave-convex groove are formed in the patch bonding portion, and a bonding structure in which a patch bonding layer is formed from the inside of the silicon shell, which is a structure that is strong in mechanical and physical resistance to pressure acting on the prosthesis. Since the joint structure is configured to disperse the stress in more than two axes along with the increase of the joint area, the mechanical and physical strength is improved, and the joint durability of the joint is improved, resulting in overall safety of the implant. It is possible to improve.
In addition, the present invention prevents the occurrence of cracks or cracks at the junction boundary between the silicon shell and the patch at the patch junction, thereby improving the joining durability of the junction.
In addition, since the thickness of the silicon shell including the patch and the patch bonding portion is configured to be the same as a whole, the overall feel of the prosthesis is very excellent, thereby increasing the effectiveness and quality of the product.
In addition, the present invention is smoothly double-sealed and finished so that the injection hole and the silicone sealing material or the edge blocking the injection hole generated by the filling material is not exposed to the outside, it is possible to achieve a beautiful sealing portion of the injection hole. .
In addition, the present invention is because the structure of the filling injection groove formed in a multi-layer, the bonding area of the sealing portion is widened, the sealing silicon used for the inlet sealing and its edge portion does not rub against the outside, the bonding strength and fatigue of the inlet sealing site Since the durability against rupture is improved and there is no fear that the sealing silicone of the injection port sealing site may fall, it is possible to increase safety against leakage of the filler.
In addition, the present invention is configured to form a structure of the filler injection groove formed in a multi-layer and to block the injection hole in a double, a phenomenon that the bonding force of the sealing portion of the injection hole is weakened due to the finely leaked filling in the injection hole portion during the filling of the filling material It is possible to prevent, to compensate for the problems caused by the mistakes of the operator, it is possible to maximize the safety against leakage of the filling.
In the above description of the preferred embodiment of the silicone artificial breast implants and the method of manufacturing the same to minimize the stress concentration according to the present invention, the present invention is not limited to the claims and the detailed description of the invention and the scope of the accompanying drawings Various modifications can be made therein and this also falls within the scope of the present invention.
10: silicon shell 11: patch ball
12: step portion 13: uneven groove
15: curved surface 16: inclined surface
20: patch 21: injection hole
25: Filling groove 28: Thin film patch
36: first sealing part 37: second sealing part
I: Prosthesis P: Patch joint
In a silicone breast implant comprising a silicone shell forming an outer wall and a patch bonding portion for closing a hole formed on the lower surface of the silicone shell from the outside,
The silicon shell is formed to have a uniform thickness as a whole, the patch bonding portion includes a patch hole formed to bond the patch to the lower end of the silicon shell with a bonding material,
The patch bonding portion, the patch is bonded to the patch hole has the same thickness as the silicon shell, silicon implant implant to minimize stress concentration, characterized in that the same or similar physical properties as the silicon shell.
The patch hole is a silicone artificial breast implant to minimize stress concentration, characterized in that at least one step is formed by forming a layer on the inner surface of the silicon shell in contact with the patch.
The patch hole is a silicone artificial breast implant to minimize the stress concentration, characterized in that the inclined surface is formed to form an increasingly wider diameter toward the step toward the step portion from the bottom.
The patch hole is a silicone artificial breast implant minimized to stress concentration, characterized in that to form a concave rounded curved surface along the outer circumference of the stepped portion.
The patch hole, the silicone artificial breast implant minimized the stress concentration, characterized in that the hole diameter of the inside of the silicon shell is formed in a structure wider than the hole diameter of the outside of the silicon shell.
At least one concave-convex groove is formed in the patch joining portion to increase the bonding area with the patch and to improve joining durability between the patches to prevent detachment of the patch joining portion. Silicone breast implants with minimal stress concentration.
The concave-convex groove is a silicon artificial breast implant minimized to the stress concentration, characterized in that formed in a "∨" shape of the pointed downward.
The concave-convex groove is a silicon artificial breast implant minimized to the stress concentration, characterized in that formed in a "∪" shape of a gentle curved shape to the lower side.
The uneven groove is an angled form of "
'' Silicon breast implant with minimal stress concentration, characterized in that formed in the shape of.
The artificial breast implant to minimize the stress concentration, characterized in that the patch is made of a mixture of low molecular silicon outflow prevention layer.
The patch bonding portion is a silicon artificial breast implant minimized to stress concentration, characterized in that it comprises a bonding material or bonding material formed between the silicon shell and the patch to be smoothly bonded.
The patch joint portion minimizes stress concentration, wherein the inner surface of the silicon shell and the inner surface of the patch are completely joined to form the same horizontal plane to prevent gaps or cracks at the junction boundary between the silicon shell and the patch. One silicone breast implant.
The patch bonding portion is a silicon artificial breast implant to minimize the stress concentration, characterized in that it comprises at least one thin film patch formed thin.
An injection hole formed on the lower surface of the patch joint portion to inject a filling material into the internal space of the silicon shell, and a filling injection groove formed at a lower side of the injection hole to form a multi-layer structure of two or more stages with fine depth. Silicone artificial breast implants with minimized stress concentration, characterized in that comprises a.
The filler injection groove is firstly filled in the lower space of the injection hole to prevent the internal space of the silicon shell from being closed from the outside, and secondly filled in the lower space of the first sealing portion. And a second sealing part which finishes the filling material injected into the internal space of the silicon shell so as not to leak to the outside.
The bonding material is a silicone artificial breast implant to minimize stress concentration, characterized in that using a gum (Gum) type silicone bonding material or a liquid type silicone (LSR: Liquid Silicone Rubber) bonding material.
The patch bonding portion acts according to the stress acting according to the left and right stretching force when the stress is applied to the junction boundary where the silicon shell and the patch are bonded to each other and the stretching force in the inclination angle direction of the stepped portion or the uneven groove section and in the inclination angle direction of the patch hole cutting section. Minimize stress concentration, characterized in that the stress acts at the same time so that the stress is dispersed in at least biaxial direction or more.
In the method of manufacturing silicone artificial breast implants,
A silicon solution dipping step of dipping the breast-shaped mold in a silicon solution to obtain a silicon shell;
A drying and curing step of drying and curing the silicon shell attached to the mold through a drying apparatus to obtain a silicon shell;
An artificial breast shell acquiring step of forming a hole in a lower end portion of the silicon shell attached to the mold to detach and obtain the silicon shell from the mold;
The step of forming a patch hole that is a portion where the patch is bonded to the hole portion of the silicon shell, to form a patch hole including a stepped portion and a concave-convex groove of a layer structure to bond the patch on the inner surface of the hole of the silicon shell Patch pore forming step;
A patch structure forming step of forming a patch including a thin film patch and a bonding material according to the layer shape and the shape of the uneven groove, including the perimeter and thickness corresponding to the patch hole so that the patch can be perfectly bonded to the patch hole without tolerances; ;
A patch bonding step of bonding the molded thin film patch, the patch structure of the patch and the bonding material onto the patch hole of the silicon shell;
A filler injection groove processing step of forming a filler injection groove forming a concave multilayer structure on a lower surface of the patch to inject filler material into the internal space of the silicon shell;
A filling step of filling and filling a filling material through an injection hole into an inner space of the silicon shell in which the filling injection groove is formed;
A first sealing is made by filling the filler injection groove with double using a sealing material so as to prevent the filling material filled in the inside of the silicon shell from flowing out from the injection hole, which is a fine hole by the needle generated by filling the filling material, to the outside. And a finishing treatment step of forming the second and second sealing parts in order.
In the patch hole forming step, the method of manufacturing a silicon artificial breast implant minimized the stress concentration, characterized in that the mechanical etching to form a step portion and the uneven groove which is a space to which the patch can be bonded on the lower surface of the silicon shell. .
In the patch hole forming step, a method for producing a silicon artificial implant with a minimum stress concentration, characterized in that the chemical etching to form a step portion and the concave-convex groove that is a space to which the patch can be bonded on the lower surface of the silicon shell. .
In the patch hole forming step, a method for manufacturing a silicon artificial breast implant with minimized stress concentration, characterized in that the laser processing to form a step portion and the uneven groove which is a space that can be bonded to the patch on the lower surface of the silicon shell. .
In the patch structure forming step, the patch including the thin film patch and the bonding material is put into a forming mold corresponding to the shape, circumference and thickness of the step portion of the patch hole and the concave-convex groove which are the portions to which the patch is bonded, and press compression molding. Method of manufacturing silicone artificial breast implants with minimized stress concentration.
In the filling injection groove processing step, since the molding plate protruding the molding portion in the shape of the filling injection groove takes a center portion of the lower surface of the patch, compression molding to form the filling injection groove is minimized Method of manufacturing silicone artificial breast implants.
In the filling injection groove processing step, the method for producing a silicon artificial breast implant with minimized stress concentration, characterized in that the laser processing so that the filling injection groove is formed concave.
In the filling injection groove processing step, the method for producing a silicon artificial breast implant minimized the stress concentration, characterized in that the mechanical etching so that the filling injection groove is formed concave.
In the filling injection groove processing step, the method for producing a silicon artificial breast implant minimized the stress concentration, characterized in that the chemical etching so that the filling injection groove is formed concave.
KR1020110061273A 2011-06-23 2011-06-23 Silicon artificial breast implants with minimized stress concentration and manufacturing method KR101235284B1 (en)
KR1020110061273A KR101235284B1 (en) 2011-06-23 2011-06-23 Silicon artificial breast implants with minimized stress concentration and manufacturing method
EP12803309.9A EP2724688A4 (en) 2011-06-23 2012-05-08 Silicon breast implant which minimizes stress concentration and method for manufacturing same
JP2014510249A JP5752851B2 (en) 2011-06-23 2012-05-08 Silicon artificial breast implant with reduced stress concentration and manufacturing method thereof
CN201280030997.4A CN103917193B (en) 2011-06-23 2012-05-08 The silica gel prothesis mamma that minimum stress is concentrated and manufacture method thereof
PCT/KR2012/003582 WO2012176982A2 (en) 2011-06-23 2012-05-08 Silicon breast implant which minimizes stress concentration and method for manufacturing same
BR112013032269A BR112013032269A2 (en) 2011-06-23 2012-05-08 silicone mana implant that minimizes stress concentration and method of manufacturing
US14/116,417 US9132004B2 (en) 2011-06-23 2012-05-08 Silicon breast implant which minimizes stress concentration and method for manufacturing same
MX2013013824A MX361030B (en) 2011-06-23 2012-05-08 Silicon breast implant which minimizes stress concentration and method for manufacturing same.
CO13283828A CO6811846A2 (en) 2011-06-23 2013-12-03 Silicone breast implant that minimizes stress concentration and method of manufacturing the same
KR20130006789A KR20130006789A (en) 2013-01-18
KR101235284B1 true KR101235284B1 (en) 2013-02-21
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