WO2022182039A1

WO2022182039A1 - Method for manufacturing artificial breast prosthesis

Info

Publication number: WO2022182039A1
Application number: PCT/KR2022/002143
Authority: WO
Inventors: 김병휘; 심은정; 김민경; 송주동; 장일석
Original assignee: 오스템임플란트 주식회사
Priority date: 2021-02-25
Filing date: 2022-02-14
Publication date: 2022-09-01
Also published as: KR102580384B1; KR20220121966A

Abstract

An embodiment of the present invention provides a method for manufacturing an artificial breast prosthesis, the method comprising: a mold coating step for coating the surface of a prosthesis-shaped mold with a silicone solution in order to obtain a shell; a shell thickness adjustment step for reinforcing the thickness of the side surface of the shell; and a shell curing step for drying or curing the shell. In the shell thickness adjustment step, the mold is rotated, and gravity and the centrifugal force due to the rotation act upon the silicone solution on the surface of the mold, thereby reinforcing the thickness of the side surface of the shell.

Description

Method for manufacturing artificial breast implants

The present invention relates to a method for manufacturing an artificial breast implant, and more particularly, to a method for manufacturing an artificial breast implant capable of preventing the rippling phenomenon in which the upper end of the implant is folded.

The implant is manufactured using a silicone material that is harmless to the human body for the purpose of not giving a feeling of rejection or resistance to the treatment site or the body. saline), hydro-gel, and silicone gel are used.

Among them, implants filled with silicone gel inside the shell have excellent durability and touch, and are widely used as cosmetic applications for correcting the shape of a specific body part, such as the nose, breast, or buttocks, or enlarging the size.

On the other hand, in the case of artificial breast implants, it is common to be implanted in vivo and exist for a long period of time. Recently, artificial breast implants have been developed to have a natural shape by controlling the physical properties of the filling, but other types of side effects are occurring.

This is often called rippling, and refers to a phenomenon in which the upper end of the implant is folded as shown in FIG. 1 . In the case of a conventional artificial breast implant, since the thickness in all parts of the shell is the same, when rippling is continuously repeated in a specific part, the physical properties of the part are weakened, thereby causing a relatively weak part. In addition, the conventional artificial breast implants are based on a single-viscosity filler, and a downward tilting phenomenon of the filler generally occurs, and this downward biasing phenomenon is a major cause of the rippling phenomenon.

As such, the artificial breast implant having a stress concentration region, which is a relatively weak region due to stress, has a limit in durability and has a problem in that the lifespan is reduced due to fatigue and ruptures in the living body when an impact is applied.

SUMMARY OF THE INVENTION The present invention is to solve the problems of the prior art described above, and an object of the present invention is to provide a method for manufacturing an artificial breast implant with improved rupture resistance against rippling.

One aspect of the present invention is a mold coating step of coating a silicone solution on the mold surface of the implant shape to obtain a shell; a shell thickness control step of reinforcing the thickness of the side portion of the shell; and a shell curing step of drying or curing the shell; Including, in the shell thickness control step, the mold is rotated, and centrifugal force according to gravity and rotation acts on the silicone solution on the surface of the mold to strengthen the thickness of the side part of the shell.

In one embodiment, the mold separation step of separating the mold from the shell; It is characterized in that it further comprises.

In one embodiment, the filling step of filling the filling in the inner receiving space of the shell; It is characterized in that it further comprises.

In one embodiment, the shell thickness control step and the shell hardening step are characterized in that made at the same time.

In one embodiment, the mold is characterized in that it is rotated by a driving unit.

In one embodiment, the mold, the apex end is arranged to face the opposite direction of the gravity direction, characterized in that it is rotated at a predetermined speed.

In one embodiment, the rotational speed of the mold is characterized in that gradually increase.

In one embodiment, the mold, its apex end is arranged perpendicular to the direction of gravity, characterized in that it is rotated at a predetermined speed.

In one embodiment, the mold, the apex end is arranged to face the direction of gravity, characterized in that it is rotated at a predetermined speed.

According to one aspect of the present invention, the thickness of the side part of the shell is increased to increase the folding durability and folding resistance of the shell, and the cohesive force of the filling side part of the implant is strengthened to prevent the filling from being drawn downward, thereby minimizing the occurrence of ripple and The durability against rippling is increased and the stability of the artificial breast implant is improved.

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

1 shows a rippling phenomenon of a conventional artificial breast implant.

2 is a flowchart of a method for manufacturing an artificial breast implant according to an embodiment of the present invention.

3 is a flowchart of a filling step according to an embodiment of the present invention.

4 is a process diagram of an artificial breast implant according to an embodiment of the present invention.

5 is a view showing various embodiments of the shell thickness control step according to an embodiment of the present invention.

6 and 7 are views showing various embodiments of the artificial breast implant manufactured according to the manufacturing method of the present invention.

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

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

As used herein, terms including an ordinal number such as 'first' or 'second' may be used to describe various elements or steps, but the elements or steps should not be limited by the ordinal number. . Terms containing an ordinal number should only be construed for the purpose of distinguishing one element or step from other elements or steps.

1 shows a rippling phenomenon of a conventional artificial breast implant. 2 is a flowchart of a method for manufacturing an artificial breast implant according to an embodiment of the present invention. 3 is a flowchart of a filling step according to an embodiment of the present invention. 4 is a process diagram of an artificial breast implant according to an embodiment of the present invention. 5 is a view showing various embodiments of the shell thickness control step according to an embodiment of the present invention. 6 and 7 are views showing various embodiments of the artificial breast implant manufactured according to the manufacturing method of the present invention.

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

As referenced, the artificial breast implant 1 according to an embodiment of the present invention is composed of a shell 100 and a filler 200 filled in the shell 100 . The shell 100 is made of a silicone material that is harmless to the human body used in applying a normal breast implant, and an accommodation space is formed therein, and various shapes are formed according to the user's needs.

An opening formed in the manufacturing process of the shell 100 and a patch part 110 for closing the opening to form an internal accommodation space are provided on the bottom surface of the shell 100 . In the receiving space of the shell 100, the filler 200 that is harmless to the human body and can give elasticity is accommodated.

Hereinafter, a method of manufacturing the artificial breast implant 1 according to an embodiment of the present invention will be described in detail.

The manufacturing method of the artificial breast implant (1) according to an embodiment of the present invention includes a mold coating step (S10), a shell thickness control step (S20), a shell hardening step (S30), a mold separation step (S40), filling of the filler Step S50 is included.

First, the mold coating step (S10) will be described. The mold 10 is formed in a breast shape, and a rod 11 formed to extend in the longitudinal direction is coupled to the bottom surface thereof. 4 , the mold 10 is immersed in the silicone solution 12 to coat the entire outer peripheral surface of the mold 10 with the silicone solution 12 . The coating method is not limited thereto, and may be coated by spraying the silicone solution 12 on the mold 10 through spraying or the like.

Hereinafter, the shell thickness adjusting step (S20) according to an embodiment of the present invention will be described in detail. As described above, in the case of a conventional artificial breast implant, since the thickness is the same in all parts of the shell, if one side is repeatedly folded, there is a problem that the physical properties of the corresponding part are weakened.

Accordingly, in the shell thickness adjusting step (S20) according to an embodiment of the present invention, the side portion of the shell 100 is reinforced by rotating the mold 10 . That is, the present invention applies centrifugal force according to the rotation of the mold 10 as well as gravity to the silicone solution 12 on the surface of the mold 10 to strengthen the side portion of the shell 100, To this end, the mold 10 is coupled to the driving unit 20 rotated at a constant speed. At this time, since it is sufficient if the shell 100 is rotated at a constant speed, the driving unit 20 of various structures may be applied. In addition, it goes without saying that external forces other than the above-described gravity and centrifugal force may additionally act on the silicone solution 12 on the surface of the mold 10 .

Specifically, as shown in FIG. 4 , when the apex end of the mold 10 is coupled to the driving unit 20 to face upward, the silicone solution 12 on the surface of the mold 10 is caused by gravity to the mold ( 10) flows downward along the outer circumferential surface. At this time, when the mold 10 is rotated by the driving unit 20 , a centrifugal force acts, so that the silicone solution 12 can be prevented from flowing down from the surface of the mold 10 .

In addition, since the centrifugal force increases as it goes away in the radial direction of the rotation shaft, the centrifugal force acts at the maximum on the side of the mold 10 that is farthest from the rod 11 .

That is, when the mold 10 is rotated as described above, the resultant force due to gravity and centrifugal force is maximally applied to the side surface of the mold 10 , so that the silicone solution 12 is more cohesive to the side surface of the mold 10 . Thus, the side portion of the shell 100 may be formed to be thick.

Meanwhile, the rotation speed of the shell 100 may be selected between 1 and 1000 rpm, which will depend on the viscosity of the silicone solution 12 and the surface tension between the surface of the mold 10 and the silicone solution 12 . For example, if the viscosity of the silicone solution 12 is high, it will not be easily separated from the mold 10 , so it will not be necessary to increase the rotation speed of the mold 10 by that much. In addition, the characteristics of the surface of the silicone solution 12 and the mold 10 will also affect the rotation speed. If the surface tension between the silicone solution 12 and the surface of the mold 10 is small, there is a possibility that the silicone solution 12 drips from the mold 10, so that a high rotation speed is preferably applied. In addition, a higher rotation speed may be applied to thicken the side portion of the shell 100 .

More preferably, the rotational speed of the shell 100 may be increased step by step from a low speed to a medium speed, a high speed. In detail, when the shell 100 rotates at a low speed, since the action by gravity is greater than the centrifugal force acting on the silicone solution 12 , the silicone solution 12 slowly flows to the bottom of the mold 10 . When the rotational speed of the shell 100 is gradually increased, the centrifugal force becomes greater than gravity, and accordingly, the silicone solution 12 aggregates on the side surface of the mold 10, and the side surface of the shell 100 becomes thick. can be

On the other hand, the rotational motion of the mold 10 may be rotated while the mold 10 is mounted perpendicular to the direction of gravity, in addition to the case where the apex end of the mold 10 faces upward, as described above. ), it can be rotated upside down so that the apex ends in the direction of gravity. Specifically, as shown in Fig. 5(b), when the mold 10 is mounted and rotated perpendicular to the direction of gravity, the silicone solution 12 flows to the side surface of the mold 10 by gravity. , the side portion may be formed to be thick. In this case, when the shell 100 is rotated at a high speed, the silicone solution 12 falls from the surface of the mold 10 , and it is preferable to rotate at a low speed so that the silicone solution 12 can be maintained on the surface of the mold 10 . .

In addition, as shown in Fig. 5 (c), when the apex end of the mold 10 is rotated to face downward, the silicone solution 12 is the apex end of the mold 10 positioned downward by gravity. and flows to the side of the mold 10 by centrifugal force. Accordingly, the thickness of the upper and lower portions of the shell 100 is minimized, and the shell 100 having a thick side portion can be formed.

Preferably, in the shell thickness adjusting step (S20), it is preferable to alternate the case where the apex end of the mold 10 is rotated to face upward and the case where the apex end of the mold 10 is rotated to face downward. . As described above, when the top end of the mold 10 is rotated to face upward, the silicone solution 12 on the surface of the mold 10 flows to the side of the mold 10 by gravity and centrifugal force. The thickness of the apex end side of the shell 100 becomes thin. Conversely, when the apex of the mold 10 is rotated to face downward, the silicone solution 12 on the surface of the mold 10 by gravity flows to the apex of the mold 10, and the silicone solution 12 The silver flows to the side of the mold 10 by centrifugal force.

That is, as described above, when the case where the apex end of the mold 10 is rotated to face upward and the case where the apex end of the mold 10 is rotated to face downward is alternately carried out, the side surface of the shell 100 While increasing the thickness, it is possible to equalize the thickness of the upper and lower sides of the shell 100 .

As described above, according to the shell thickness adjusting step (S20) according to an embodiment of the present invention, since the shell 100 with a reinforced side part is formed, the folding resistance of a specific part is increased, and the folding durability can also be increased at the same time.

Thereafter, in the shell curing step (S30), the silicone solution 12 coated on the surface of the mold 10 as described above is dried or cured naturally or through a drying device to adhere to the mold 10, and thus the silicone shell (100) is formed. Preferably, in the above-described shell thickness control step (S20), the silicone solution 12 may be dried or cured through a drying device at the same time as the mold 10 is rotated.

Thereafter, in the mold separation step (S40), the rod 11 coupled to the mold 10 is removed, and an opening formed at the connection portion between the mold 10 and the rod 11 is opened to form the silicon shell 100 in the mold ( 10) by turning it over and removing it, so that the shell 100 can be obtained. Then, by bonding the patch part 110 of a silicone material having the same elasticity and physical properties as the shell 100, the opening is closed.

Hereinafter, the filling step (S50) according to an embodiment of the present invention will be described in detail.

As a filling method of the filler 200, an injection injection method is applied, but preferably, the filler 200 may be injected by inserting an injection into the receiving space through the patch 110, and as an example of the filler 200, saline solution Fillers of various materials such as (saline), hydro-gel (hydro-gel) and silicone gel (silicone gel) can be applied.

On the other hand, as described above, in conventional artificial breast implants, a downward biasing phenomenon generally occurs based on a single-viscosity filler, and this downward biasing phenomenon is a major cause of the rippling phenomenon.

Therefore, in the present invention, the shell 100 is characterized in that the filling is filled so that the physical properties are different for each internal position. Preferably, it is characterized in that the shell 100 is rotated and the filling is filled so that a silicone filling with strong cohesive force can be formed on the side portion of the inner receiving space of the shell 100 . That is, in the present invention, not only gravity but also centrifugal force according to the rotation of the shell 100 is applied to the silicone filling inside the shell 100 to flow the silicone filling to the inner side of the shell 100 . At this time, of course, external forces other than the above-described gravity and centrifugal force may additionally act on the silicone filling inside the shell 100 .

Specifically, the filling step according to an embodiment of the present invention includes a first filling step (S51), a rotation hardening step (S52), a second filling step (S53), and a curing step (S54).

First, as shown in FIG. 4 , the first filler 210 is injected into the receiving space inside the shell 100 by inserting an injection into the patch part 110 . At this time, the first filler 210 is selected as a material having higher viscosity and cohesiveness than the second filler 220 to be described later. Then, the shell 100 is seated on the driving unit 20 rotating at a constant speed. Centrifugal force according to gravity and rotation of the driving unit 20 acts on the first filling material 210 , and it flows to the side of the shell 100 inner accommodation space. In that state, when curing through a drying device, the first filler 210 is positioned on the side of the shell 100 .

Here, the rotation speed of the shell 100 may be adjusted according to the height of the side portion to be formed and the viscosity of the filling, and may be preferably selected between 1 and 1000 rpm.

Next, the second filler 220 having lower viscosity and cohesiveness than the first filler 210 is injected into the patch 110 to fill the remaining accommodation space, and the filler is secondarily cured through a drying device. As a result, as shown in FIG. 6 , it is possible to obtain the artificial breast implant 1 in which the first filler 210 having high viscosity and cohesiveness is disposed on the side surface.

That is, according to the filling step (S50) according to an embodiment of the present invention, the filling is drawn downward by strengthening the cohesive force of the filling in the side part of the artificial breast implant (1), which may be vulnerable to rupture due to frequent rippling. As a result, the rupture resistance of the artificial breast implant (1) is increased. Accordingly, it is possible to prevent the artificial breast implant 1 from being ruptured in vivo.

On the other hand, even without going through the rotation hardening step (S52), as shown in FIG. 7, the artificial breast implant 1 with reinforced side and bottom surfaces may be obtained. For example, the shell 100 is mounted upside down, the first filler 210' is filled and cured, and then the second filler 220 having high viscosity and cohesiveness is placed above the cured first filler 210'. When filling and curing again, the artificial breast implant 1 with reinforced side and bottom surfaces can be obtained.

According to the method for manufacturing the artificial breast implant (1) according to an embodiment of the present invention, the folding durability and folding resistance of the shell 100 are increased, and the side filling cohesive force of the artificial breast implant (1) which may be vulnerable to rupture As this is strengthened, the occurrence of rippling is minimized and durability against rippling is increased, so that the stability of the artificial breast implant (1) is improved.

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

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

[Explanation of code]

1 Artificial breast implant

10 mold

11 rods

12 silicone solution

20 drive

100 shells

110 patch part

200 filling

210, 210' first filler

220, 220' 2nd filler

Claims

In order to obtain a shell, a mold coating step of coating a silicone solution on the mold surface of the shape of the implant;

a shell thickness control step of reinforcing the thickness of the side portion of the shell; and

a shell curing step of drying or curing the shell; including,

In the shell thickness control step, the mold is rotated, and centrifugal force according to gravity and rotation acts on the silicone solution on the mold surface to strengthen the thickness of the side part of the shell.
The method of claim 1,

a mold separation step of separating the mold from the shell; A method for manufacturing an artificial breast implant, characterized in that it further comprises a.
The method of claim 1,

a filling step of filling the shell inner accommodating space with a filling material; A method for manufacturing an artificial breast implant, characterized in that it further comprises a.
The method of claim 1,

The method for manufacturing an artificial breast implant, characterized in that the shell thickness control step and the shell hardening step are performed at the same time.
The method of claim 1,

The mold is rotated by a driving unit, the artificial breast implant manufacturing method.
The method of claim 1,

The mold, an artificial breast prosthesis manufacturing method, characterized in that the apex end is arranged to face the direction opposite to the direction of gravity, characterized in that rotated at a predetermined speed.
7. The method of claim 6,

Method for manufacturing an artificial breast implant, characterized in that the rotation speed of the mold is gradually increased
The method of claim 1,

The mold, the apex end is disposed so as to be perpendicular to the direction of gravity, characterized in that the rotation at a predetermined speed, artificial breast prosthesis manufacturing method.
The method of claim 1,

The mold, an artificial breast prosthesis manufacturing method, characterized in that the apex is disposed to face the direction of gravity, characterized in that rotated at a predetermined speed.