JP2013000333A - Method for manufacturing artificial nipple and kit therefor - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a method for manufacturing an artificial nipple and a kit therefor, capable of easily manufacturing an artificial nipple.SOLUTION: The method for manufacturing an artificial nipple 1 includes: a step of preparing a half-cured first resin 53 for transcribing a nipple in a molding casing; a step of pressing the first resin 53 to the nipple portion and transcribing the nipple in a concave shape to form a female mold 800; a step of injecting a second resin 54 colored in a breast approximate color into the female mold 800 transcribed in a concave shape; and after the second resin 54 is half-cured, a step of releasing the cured second resin 54 as the artificial nipple 1 from the concave female mold 800.

Description

  The present invention relates to a method for producing an artificial nipple for nipple loss and a kit for producing the same.

  Conventionally, when a breast is removed in breast cancer or the like, surgical breast reconstruction has been performed in order to compensate for the balance between the appearance and weight of the remaining one breast.

  In this breast reconstruction, an autologous tissue is transplanted by a surgical operation or an artificial prosthesis (implant) is implanted in a breast defect site. Furthermore, in order to supplement the nipple (including the areola), an artificial nipple formed as a separate body is used as an example for this breast reconstruction site (Patent Document 1, etc.).

Japanese National Patent Publication No. 10-502007

  However, in order to manufacture such an artificial nipple, it is currently necessary to rely on a specialist, and a proposal that can be easily created as an individual is desired.

  An object of the present invention is to provide a method for producing an artificial nipple and a kit for producing the same, which can easily produce an artificial nipple.

  In order to solve the above problems, the method for producing an artificial nipple of the present invention is a method for producing an artificial nipple, in which the shape of a nipple composed of an existing nipple and a ring portion around the nipple is molded with a soft resin, and an impression material Preparing a first resin for nipple transfer in which an impression curing agent is mixed with an impression main agent in a molded container in a semi-cured state, and an exposed surface of the first resin exposed from a container opening of the molded container Pressing the nipple portion until the first resin is cured, and transferring the outer shape of the nipple portion into a concave shape on the exposed surface to form a female mold portion, and a soft resin of the molding material. A step of injecting or laminating a flowable second resin in which a molding hardening agent is mixed with a molding main agent colored in an approximate nipple color into the female mold part, and after the second resin is cured, the cured second resin Release the resin from the female mold as an artificial nipple Characterized in that it comprises a degree, the.

  By adopting the above-described configuration, the first resin in the molded container body is in a semi-cured state in which free flow is limited (both in a case where the fluid is deformed to some extent by gravity or is not substantially fluidly deformed unless force is applied). Handling) and easy to transfer.

The artificial breast preparation kit of the present invention is an artificial nipple preparation kit for molding a form of a nipple part composed of an existing nipple and a peripheral ring part thereof with a soft resin, and contains an impression main agent in an impression material. A first container, a second container containing an impression curing agent used by mixing with the impression main agent, a third container body containing a molding main agent in the molding material, and a molding hardening used by mixing with the molding main agent. And a cup-shaped molded container body that contains the first resin for transferring the nipple by mixing the impression main agent and the impression curing agent. By storing various functional products for the production method in, for example, one box, it is possible to provide a simple production kit.
Note that the first container or the second container may also be used as the molded container body.

  Further, in the artificial nipple preparation kit, the first container and the second container are impression material containers, while the third container body and the fourth container body are molding material containers, and the molding material containers and the impression material By making the appearance color different from that of the containers, the impression material and the molding material can be easily distinguished from each other by the difference in the appearance color, and misuse of the impression material and the molding material is less likely to occur.

It is a figure which shows the artificial nipple stuck on the breast reconstruction site | part of a wearer's breast defect part. It is a figure which shows the preparation kit for creating an artificial nipple. It is a figure which shows the form of the 1st container in a preparation kit. It is a figure which shows the attitude | position of the 1st container explaining the semi-hardened state in a pot life. It is a figure which shows a cup-shaped 1st container. It is a figure which shows the preparation process of an artificial nipple. It is a figure which shows the process following the preparation process of the artificial nipple of FIG. It is a figure which shows the state which affixes an artificial nipple on a breast reconstruction site | part. It is a figure which shows the state which removes the artificial nipple affixed on the breast reconstruction site | part. It is a figure which shows the example of preparation of the artificial teat by the taper-shaped container which is another example of a cup-shaped 1st container. It is a figure which shows the bottle-shaped container which is another example of a cup-shaped 1st container. It is a figure which shows the other transfer example of the female-type part by a 1st container. It is a figure which shows the creation example of the artificial nipple by the female type | mold part of FIG. It is a figure which shows the other transfer example of the female-type part by a 1st container.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. FIG. 1 is a view showing an artificial nipple 1 to be affixed to a breast reconstruction site 200 of a breast defect site 100 of a wearer. FIG. 2 is a view showing the entire preparation kit 2 for forming the artificial nipple 1.

  In FIG. 1, breast reconstruction for supplementing a breast defect site 100 in the chest after excision of breast in breast cancer or the like is performed by transplanting an autologous tissue by a surgical operation or an artificial prosthesis (implant) made of, for example, silicone rubber. A breast reconstruction site 200 is formed so as to be embedded in the defect 100. Since such a breast reconstruction site 200 generally does not have a nipple, an artificial nipple 1 including a nipple portion 1a and a ring-shaped portion (areola portion) 1b is created so as to be attached thereto.

  As shown in FIG. 2, a kit 2 for producing an artificial nipple 1 for this purpose is formed of a soft resin in a box (storage box) 3 such as a rectangular box having an opening / closing lid 3a provided on the upper opening side so as to be opened and closed. Impression material containers 4 for storing the impression material for molding, molding material containers 5 for storing the molding material that is a soft resin, and auxiliary material container 6 for storing the release agent 300 used at the time of molding. And a stirring and mixing rod 7 such as a spoon.

  The soft resin used for the impression material is a room temperature vulcanization type silicone rubber, that is, a two-component addition reaction type RTV silicone rubber obtained by mixing a so-called main agent (base polymer) and a curing agent (catalyst). The first container 14 and the second container 24 are separately formed as impression material containers 4 for the two-component addition reaction type RTV silicone rubber impression main agent 51 and impression curing agent 52. An impression main agent 51 is accommodated in the container 14, and an impression curing agent 52 is accommodated in the second container 24.

In the first container 14 as the impression material container 4, an impression main agent 51 is accommodated in the first container 14 before using the mold, but the second container 24 with respect to the impression main agent 51 in the first container 14 at the time of mold preparation. Is used as a cup-shaped molded container body for preparing the first resin 53 (FIG. 4) obtained by mixing and mixing the impression curing agent 52 at a predetermined ratio. The second container 24 may be a molded container body. In short, either the first container 14 or the second container 24 is a molded container body.
However, a molded container body different from the first container 14 or the second container 24 may be prepared, and the first resin 53 may be accommodated therein.

  The form of the first container 14 will be described in detail. As shown in FIG. 3, the diameter 140 (in other words, opening area) of the container opening 14 a in the first container 14 (molded container body) is the exposed surface of the first resin 53 that is prepared and accommodated in the first container 14. 53a (FIG. 4) is set to a range in which the shape of the nipple portion including the existing nipple 401 and the surrounding annular portion (milk areola) 402 shown in FIG. 1 can be transferred. For example, the first container 14 having a diameter (opening area) 140 that substantially matches the outer edge of the existing nipple portion (the nipple 401 and the ring-shaped portion 402) can be used (in this case, as a result of transferring the existing nipple portion). The second resin 54 is filled so as to fill up the opening edge of the recess (female part) 800). Alternatively, the first container 14 having a larger diameter (opening area) 140 than the outer edge of the existing nipple part can be used, and in this case, the opening edge of the recess (female part) 800 generated as a result of transferring the existing nipple part. It is possible to fill the second resin 54 to a level that does not reach the level and mold the artificial nipple 1 that is almost the same size as the existing nipple portion. However, the first resin 54 is filled to the opening edge of the recess (female portion) 800. If the two resins 54 are filled, the artificial nipple 1 having an outer shape larger than that of the existing nipple portion can be created.

  By using the first container 14 as such a molded container body, the nipple portion including the nipple 401 and the ring-shaped portion 402 can be transferred to the first resin 53.

  The first resin 53 at the time of transfer is a pot life in which the first resin 53 as a mixture has a certain degree of viscosity and fluidity from the start of mixing the impression main agent 51 and the impression curing agent 52. Used within (pot life).

  In the pot life, as shown in FIG. 4, the container opening 14 a of the first container 14 is placed in a posture, for example, obliquely upward, horizontally, obliquely downward from the posture in which the first container 14 is along the vertical direction. Even if it is changed, the first resin 53 has a certain degree of viscosity from the inside of the first container 14, so that it does not easily flow out and pushes the nipple portion existing on the first resin 53 and the nipple portion composed of the annular portion 402 around it. In the applied state, the first resin 53 is pressed and deformed by the nipple portion including the nipple 401 and the ring-shaped portion 402, and the outer shapes of the nipple 401 and the ring-shaped portion 402 can be transferred in a concave shape. This state is a typical example of the semi-cured state of the first resin 53.

  The first container 14 is formed of, for example, polyethylene, acrylic, polystyrene, polypropylene, PET resin (transparent), or the like.

  Returning to FIG. 2, two-component addition reaction type RTV silicone rubber is used as the soft resin used for the molding material. In order to accommodate the molding main agent 61 and the molding curing agent 62 of the two-component addition reaction type RTV silicone rubber, as the molding material containers 5, the third container 35, 35a and the fourth container 45, 45a are separately provided. They are formed, and a molding main agent 61 is contained in the third containers 35 and 35a, and a molding curing agent 62 is contained in the fourth containers 45 and 45a.

  Each forming main agent 61 in the third containers 35 and 35a is colored in advance with a different nipple approximate color. For this coloring, a pigment as a general coloring agent (for addition-type liquid silicone rubber) is used. The third container 35, 35a (and the fourth container 45, 45a for curing) are prepared with different nipple approximate colors because the difference in the color of the remaining nipple due to age, individual differences, etc. This is because the color of the artificial nipple is adjusted to a color as close as possible.

  Moreover, as a basic form of the first container 14, the second container 24, the third container 35, 35a, and the fourth container 45, 45a, as shown in FIG. 5, the cup body 8 formed in a bottomed cylindrical shape is used. It is a cup type in which the female screw portion 82 of the cap body 8a is screwed into the male screw portion 81 on the upper opening side.

  Further, in order to prevent misuse of the soft resin used for the impression material and the soft resin used for the molding material, the first container 14 and the second container 24 as the impression material containers 4 have the same appearance color. On the other hand, the appearance colors of the third container 35, 35a and the fourth container 45, 45a as the molding material containers 5 are the same color, and the impression material containers 4 and the molding material containers 5 have the same appearance color. It can be identified as different colors.

  In this example, the color of the cap body 8a in each container is color-coded so that it can be recognized immediately when the opening / closing lid 3a of the box 3 is opened.

  Examples of silicone rubber as a synthetic resin that is a soft resin of an impression agent and a molding material for producing the artificial nipple 1 are “USA, Factor 2 Company: VST-30, VST-50, VST-50F, VST- "50HD, A-2000", "Toray Dow Corning: SH95555RTV, 9556RTV, MDX4-4210", "Momentive Performance Materials Japan: TSE3453, TSE3456T, TSE3475T, TSE3431, YE5626" In addition, “manufactured by Shin-Etsu Chemical Co., Ltd .: KE-1308, KE-1300T, KE-1310ST, KE-1314-2, KE-1316, KE-1310ST, KE-1600, KE-1603 (A / B), KE -1606, SIM-260, SIM-2 0 ", also," Asahi Kasei Wacker Silicone Co., Ltd.: DENTAL ADS931 A / B, M4600A / B, M4641A / B, M4644A / B, M4645A / B, P7613A / B, and the like can be mentioned P7664A / B ". The artificial nipple 1 is obtained by curing in a rubber shape at room temperature (also called normal temperature, which is 20 ° C. ± 15 ° C. in the Japanese Industrial Standard (JISZ8703)).

  Examples of pigments include "USA, Factor 2 Company: FE-235, FE-202, FE-200, FE-228", "Shin-Etsu Chemical Co., Ltd .: K-COLOR-R20, K-COLOR-W10". , K-COLOR-BL70, K-COLOR-Y40 ", or" Momentive Performance Materials Japan, Inc .: ME50-M, ME50-R2, ME50-W, ME50-Y "and the like. .

  The artificial nipple 1 is manufactured as follows. As shown in FIG. 6, the impression hardening agent 52 in the second container 24 is filled in the impression main agent 51 in the first container 14 in a predetermined composition (impression material filling step, FIG. 6 (b)), and then The first resin 53 is prepared in the first container 14 by manual mixing using the mixing stirring bar 7 (impression material preparation step, FIG. 6C). The first container in this example is formed in a cylindrical shape.

  In this preparation step, the first resin 53 that is semi-cured in the pot life after a predetermined time from the start of mixing is exposed from the opening (container opening 14a) of the molded container body. The exposed surface 53a is pressed against the nipple portion including the existing nipple 401 and the ring-shaped portion 402 and is held until the pot life has passed to cure the first resin 53, so that the exposed surface 53a is exposed from the nipple 401 and the ring-shaped portion 402. A step of transferring the outer shape of the nipple portion to a concave shape is performed to form a female mold portion 800 (transfer step of the nipple portion, FIGS. 6D and 6E). The first resin 53 in the first container 14 retains a certain level of viscosity in the pot life but does not lose fluidity. Therefore, when the first container 14 is tilted downward, for example, obliquely downward from the vertical (vertical) state. The one resin 53 flows so as to spread along the skin surface around the nipple portion. At this time, the first resin 53 leaks from the first container 14 by the container opening 14a being pressed against the surface of the nipple portion. There is nothing.

  Next, as shown in FIG. 7, the molded container body (first container 14) in which the female mold portion 800 is formed is separated from the nipple portion (FIG. 7A), and this molded container body (first container 14). The step of injecting or laminating (building up) the second resin 54 into the female mold portion 800 of the first resin 53 in FIG. The second resin 54 is mixed with the molding main agent 61 in the third container 35 colored in the approximate nipple color with the molding curing agent 62 in the fourth container 45, and then manually using the mixing and stirring rod 7. Mix and adjust. In this way, the second resin 54 is prepared in the molded container body (molding material preparation step, FIG. 7B).

  The adjusted second resin 54 is injected into the female portion 800 transferred in a concave shape. (Forming material injection step, FIG. 7C). In this injection state, the first container 14 is rotated around the vertical axis, and the second resin 54 is diffused to the peripheral portion, thereby forming a thin outer edge portion and providing an artificial back surface having a concave central portion. Let's say nipple 1. Thereafter, the second resin 54 is cured and then taken out as a cured product, whereby the artificial nipple 1 including the nipple portion 1a and the ring-shaped portion (milk ring portion) 1b is manufactured (the step of taking out the molded product, FIG. 7 (d). )).

  Thereafter, as shown in FIG. 8, the artificial nipple 1 with the adhesive 900 applied to the back surface is attached to the breast reconstruction site 200. In addition, as shown in FIG. 9, it is possible to remove the artificial nipple 1 from the breast reconstruction site 200 using the release agent 901. In addition, as an adhesive, "Toray Dow Corning company make: MD7-4502 SILICONE ADHESIVE, MD7-4602 SILICONE ADHESIVE", "Holister company make: Medical Adhesive Spray", "ADM Tronics company make: PROS-AIDE" “Daro: Adhesive” and the like. Examples of the release agent include “Smith & Nephew: Remove”, “Arcare: Procare Remover”, and “Sumitomo 3M: Skin Remover”.

(Example)
As an example of the preparation kit 2 for the artificial nipple 1, a silicone rubber (DENTAL ADS931 A manufactured by Asahi Kasei Wacker Silicone Co., Ltd.) as an impression main agent 51 in which the above-mentioned pigment selected for coloring is preliminarily mixed in the first container 14. ) In the second container 24, silicone rubber (made by Asahi Kasei Wacker Silicone Co., Ltd .: DENTAL ADS931 B agent) as the impression curing agent 52, and silicone rubber (USA, Factor 2) in the third containers 35 and 35a. Company: VST-30 main agent) in the fourth containers 45 and 45a, a molding rubber 62 as a silicone rubber (Factor 2, USA: VST-30 hardener), and the auxiliary material container 6 as a release material 300 In a state filled with a predetermined amount of Vaseline, etc., each was stored in a box 3 and prepared as a preparation kit 2 (FIG. 2).

  As an example using this artificial nipple 1 preparation kit 2, 100% by weight of silicone rubber (DENTAL ADS931 A agent manufactured by Asahi Kasei Wacker Silicone Co., Ltd.) as an impression main agent 51 in the first container 14 as a molded container body. On the other hand, silicone rubber (made by Asahi Kasei Wacker Silicone Co., Ltd .: DENTAL ADS931 B agent) as the impression curing agent 52 was 10 to 100% by weight, and the first resin 53 was prepared by filling and mixing.

  And the external shape of the teat 401 and the ring-shaped part 402 which apply | coated the petrolatum as the mold release agent 300 of the auxiliary | assistant material container 6 to the 1st resin 53 in the 1st container 14 was transferred to concave shape, and the female part 800 was formed. .

  Next, with respect to 100% by weight of the silicone rubber as the molding main agent 61 (US, manufactured by Factor 2 Company: VST-30 main agent), the silicone rubber as the molding curing agent 62 (manufactured by Factor 2, Company: VST-30 cured) The second resin 54 was prepared by filling and mixing at 10 wt%.

  Then, after applying petrolatum to the female mold part 800, the second resin 54 was injected or laminated (filled) on the female mold part 800. And the artificial nipple 1 was manufactured by taking out as hardened | cured material after hardening of the 2nd resin 54. FIG.

  In addition, the 1st container 14 as a shaping | molding container body is not limited to a cylindrical shape, As shown to Fig.10 (a), what is formed in a taper cylinder shape (sealed with the lid | cover not shown) may be sufficient. FIG. 10B shows a state in which the artificial nipple 1 is formed after the tapered tubular first container 14 is used and a molding material is injected into the female mold portion 800. As shown in this figure, the back surface of the artificial nipple 1 may be a flat surface instead of a concave curved surface, and the flat surface is bonded to the nipple reconstruction site while being deformed by the adhesive of FIG. Further, instead of the cup-shaped first container 14, the second container 24, the third container 35, 35a and the fourth container 45, 45a, as shown in FIG. The cap body 9d is screwed into the mouth portion 9c of the bottle body 9 which includes the bottle body 9 having the mouth portion 9c which becomes the male screw cylinder portion 91 through the portion 9b and the cap body 9d having the female screw portion 92. It is good also as a bottle type with which a formula is equipped.

  In this bottle-shaped container form, as a container for mixing the impression main agent 51 and the impression curing agent 52, in order to prepare the first resin 53 that can transfer the outer shape of the nipple 401 and the ring-shaped portion 402 into a concave shape. Separately, the same shape as the cup body 8 may be prepared as a molded container body.

  In addition, as shown in FIG. 12, when pressing the 1st container 14 which has a larger diameter than the outer edge of the nipple part 1 comprised from the nipple 401 and the ring-shaped part 402 against a nipple part, the shape including a nipple part and its periphery is 1st. Transferred to one resin 53. By injecting the second resin 54 into the transferred concave portion 850, the artificial nipple 1 that is slightly larger than the annular portion of the nipple portion can be created.

  Furthermore, as shown in FIG. 13, the artificial nipple 1 having the same size as the existing nipple portion is formed by injecting the second resin 54 into a portion other than the peripheral portion instead of filling the entire concave portion 850. It can also be.

  At this time, after injecting the second resin 54 into the recess 850, etc., the first container 14 is rotated around the vertical axis, and the second resin 54 is diffused to the peripheral portion, thereby forming a thin outer edge portion. It can also be set as the artificial nipple 1 provided with the back surface in which the center part curved concavely.

  Further, as shown in FIG. 14, the first resin 53 (which has little fluidity) in a state where the viscosity is somewhat high is pressed against the nipple portion, and the portion except the inner peripheral side of the container opening 14 a of the first container 14 is applied. It is also possible to form the artificial nipple 1 by forming the transfer recess 851 and injecting the second resin 54 therein.

  As mentioned above, although embodiment of this invention was described, these are only illustrations to the last, this invention is not limited to these, The existing nipple part may be a wearer's own and others. . Further, in each embodiment, the configuration described as a part of one embodiment for explaining the present invention is used in another embodiment, and these are combined to form another embodiment. can do.

DESCRIPTION OF SYMBOLS 1 Artificial nipple 2 Creation kit 14 1st container 24 2nd container 35, 35a 3rd container 45, 45a 4th container 51 Impression main agent 52 Impression hardening agent 53 1st resin 54 2nd resin 61 Molding main agent 62 Molding hardening agent

Claims (3)

A method for producing an artificial nipple, which is formed by using a soft resin to form a nipple portion composed of an existing nipple and a ring-shaped portion around the nipple.
Preparing a first resin for nipple transfer, in which an impression curing agent is mixed with an impression main agent of an impression material, in a molded container in a semi-cured state;
The exposed surface of the first resin exposed from the container opening of the molded container body is pressed against the nipple portion until the first resin is cured, and the outer shape of the nipple portion is made concave on the exposed surface. Transferring and forming a female mold part;
A step of injecting or laminating into the female mold part a second resin having fluidity in which a molding hardening agent is mixed with a molding main agent obtained by coloring a soft resin of a molding material in a color similar to a nipple;
After the second resin is cured, a step of releasing the cured second resin from the female mold part as an artificial nipple;
A method for producing an artificial nipple, comprising: An artificial nipple creation kit that molds the shape of a nipple part consisting of an existing nipple and its surrounding ring-shaped part with a soft resin,
A first container for storing an impression main agent in an impression material;
A second container containing an impression curing agent to be used in combination with the impression main agent;
A third container housing a molding agent in the molding material; a fourth container housing a molding curing agent used by mixing with the molding agent;
A kit for producing an artificial nipple, comprising: a cup-shaped molded container body containing the first resin for transferring a nipple by mixing the impression main agent and the impression curing agent.   The first container and the second container are impression material containers, while the third container body and the fourth container body are molding material containers, and the molding material containers and the impression material containers have an appearance color. The artificial nipple preparation kit according to claim 1, wherein the kit is different.

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