JPH07255765A - Ostomy kit and its manufacture - Google Patents

Abstract

PURPOSE:To correspond to a stoma of a specific shape by forming a male die from a female die formed on a stoma peripheral part with thermoplastic resin and coupling an adhesive layer with the entire plane on the side provided with a surface in accordance with the surface shape of the stoma peripheral part of a supporting plate formed by the male die. CONSTITUTION:Forming is performed by soaking a thermoplastic resin plate 43 in a hot water and taking it out after it is softened and abutting it with the periphery of the stoma 46 so as to fit the hole 44 of the thermoplastic 43 in the stoma 46. When the thermoplastic resin plate 43 is removed from the stoma 46, the female die 48 provided with the surface 47 along with the surface shape of the stoma peripheral part can be obtained on one side of the thermoplastic resin plate 43. Thence, a male die 49 is manufactured setting the female die 48 as a master die, and the supporting plate 405 is manufactured by using the male die 49 by, for example, vacuum forming. The skin contact part of an ostomy kit can be formed by attaching the adhesive layer 407 on the surface 406 of the supporting plate 404 with a pressure sensitive adhesive and further, placing peeling film 408 on the adhesive layer 407.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an ostomy appliance which is attached to a stoma built in a human body by a surgical operation and accommodates excrement from the body.

[0002]

2. Description of the Related Art Ostmate, which has an artificial anus, artificial bladder, etc. constructed by a surgical operation, has a skin-attaching portion having an opening corresponding to the stoma fixed to the stoma portion with its adhesive layer,
The ostomy appliance with a bag attached to the skin is used to deal with excretion from the stoma. After surgery, ostomate becomes fat or thin, or more than 90% of people have stoma due to aging. There are various modes of deforming the stoma, such as the stoma itself having a round shape at first becoming distorted, or the circumference of the stoma being depressed, but there is a great problem particularly in the depression around the stoma. In a conventional ostomy appliance, the skin part is cut and attached to the stoma part according to the shape of the stoma, but for the collapsed stoma, the skin part floats above the stoma and leaks, causing Even if the part adheres to the skin, the durability is extremely reduced, causing skin problems.
Further, when the shape of the stoma changes and a gap is formed between the peripheral edge of the stoma and the opening of the skin-contacting part, and the skin is exposed, excrement may adhere to the skin and cause a rash.

For a depressed stoma, a so-called face ring is incorporated in the skin contact portion, and a pressing force is applied to the periphery of the stoma to push out the stoma (for example, Japanese Utility Model Publication No. 2-36500). This face ring has a central hole facing the stoma, and it is prepared that the size of this central hole is changed in several stages, but if the stoma is deformed, the stoma can fit inside the face ring. A large size must be selected, and as a result, the skin exposed around the stoma in the center hole of the face ring becomes large at the deformed part of the stoma, and excrement may adhere to it and rash may occur. If the stoma collapses too deep, there is a problem that the ready-made face ring does not have a size that can be accommodated, and it is not possible to sufficiently cope with the deformation of the stoma. Furthermore, since this face ring constantly presses strongly around the stoma at the edge of its center hole, it is not preferable from the viewpoint of skin care, and in severe cases it may cause pigmentation and keratinization,
There is also a problem with using the face ring itself.

[0004]

SUMMARY OF THE INVENTION It is an object of the present invention to provide an ostomy appliance and a method for manufacturing the same, which can cope with a deformed stoma, in particular a depressed stoma, or any other specially shaped stoma, and which does not cause an obstacle in the stoma part. To provide.

[0005]

In order to achieve the above object, in the ostomy appliance of the present invention, a male mold is formed from a female mold formed around the stoma with a thermoplastic resin or room temperature curable silicone. Molded, bonded to the entire surface of the side having a surface corresponding to the surface shape of the stoma periphery of the support plate molded from this male mold, and a bag for storing excrement on the other side of the support plate. Install.

In the method for manufacturing an ostomy appliance according to the present invention, a hole along the shape of the stoma is provided at the center of the thermoplastic resin plate, and the thermoplastic resin plate is heated and softened so that the stoma fits into the hole. A mold is applied to the peripheral part and cured by the temperature drop of the thermoplastic resin plate to mold a female mold, a male mold is molded from this female mold, and the male mold is used to support the stoma corresponding to the shape of the peripheral part. A plate is molded, an adhesive layer is bonded to the entire surface of the support plate on the surface side corresponding to the surface shape of the stoma, and a bag for storing excrement is attached to the other side of the support plate.

In another method for manufacturing an ostomy appliance according to the present invention, a mold surrounding the stoma is arranged around the stoma, and room temperature curable silicone is poured into the mold to be cured and taken out from the mold. Mold the male mold using the cured silicone as the female mold, mold the support plate corresponding to the shape of the stoma peripheral part using this male mold, and the entire surface on the side corresponding to the surface shape of the stoma peripheral part of the support plate The adhesive layer is bonded to and the bag for storing excrement is attached to the other side of the support plate.

[0008]

In the present invention, a stoma is directly used to form a master mold having a surface shape completely matching the shape of the periphery of the stoma with a thermoplastic resin or room temperature curable silicone, and a support plate is molded based on the master shape. As a result, the support plate also has the same surface shape as the stoma peripheral part, and when it is attached to the stoma via the adhesive layer bonded to this support plate, the adhesive layer adheres to the circumference of the stoma and becomes close to the skin. No gap is created.

[0009]

Embodiments of the present invention will be described below with reference to the drawings.

FIG. 1 is a sectional view of an example of an ostomy appliance according to the present invention, in which 1 is a support plate and 2 is an adhesive layer bonded to the support plate 1, both of which have an opening 3 in the center thereof. A peeling film 4 is placed on the surface of the adhesive layer 2 to protect the surface of the adhesive layer 2 when not in use. 5 is a first fitting portion attached to the opposite side of the support plate 1 from the adhesive layer 2,
Reference numeral 6 is a second fitting portion corresponding to the first fitting portion 5, and 7 is a bag body fixed to the second fitting portion 6 for fitting or removing both fitting portions 5, 6. Thereby, the bag body 7 can be connected to the support plate 1 or detached from the support plate 1. The surfaces of the support plate 1 and the adhesive layer 2 on the side opposite to the bag body 7 have a shape corresponding to the shape of the peripheral portion of the stoma to be mounted.

FIG. 2 shows a state in which the ostomy appliance shown in FIG. 1 is attached to the stoma portion. The release film 4 is removed so that the support plate 1 and the opening 3 of the adhesive layer 2 are located at the stoma 8. When the adhesive layer 2 is pressed against the skin 9, the brace is fixed to the stoma part. At this time, the adhesive layer 2
The surface of is closely attached to the peripheral portion 10 of the stoma 8 and no gap is formed therebetween. The excrement is accommodated in the bag body 7 by the stoma 8 as shown by the arrow, and the excrement in the bag body 7 can be treated by removing both fitting portions 5 and 6, and the inside of the bag body 7 can be treated. It can be reused by washing.

FIG. 3 shows a sectional view of another example of the ostomy appliance according to the present invention, and the same parts as those in FIG. 1 are designated by the same reference numerals. In this example, the bag body 7 is directly fixed to the support plate 1 without a fitting portion. Also in this case, the adhesive layer 2 adheres to the periphery of the stoma and no gap is formed between them.

FIG. 4 shows an example of a manufacturing process of the support plate and the adhesive layer of FIGS. In a), reference numeral 41 is a stoma cutting gauge, which is made of a paper pattern having a size of about 15 cm × 15 cm, and is directly applied to the stoma to make a hole 42 along the size of the stoma. 15 cm x 15 cm using this stoma cutting gauge 41 in b)
A hole 44 in the shape of a stoma is made in the thermoplastic resin plate 43 of about 1 mm. In c), the thermoplastic resin plate 43 is
Soak in warm water 45 ° C for about 3 minutes and take out when it becomes soft, and then attach the thermoplastic resin plate 4 to the stoma 46 as shown in d).
The hole 44 of No. 3 is brought into contact with the periphery of the stoma 46, and the pattern is taken. Since the thermoplastic resin plate 43 cures as the temperature decreases, a female mold 48 having a surface 47 conforming to the surface shape of the periphery of the stoma is obtained on one side of the thermoplastic resin plate 43 when removed from the stoma, as shown in e). To be Next, using this female mold 48 as a master mold, a male mold 49 for molding is made by, for example, a profile lathe as shown in f).
The shape of the surface 401 of the mold 49 is the surface 47 of the female mold 48.
It is exactly the same as the shape of. The support plate is made using the mold 49, for example, by vacuum forming. That is, as shown in g), the mold 49 is arranged at the bottom of the outer frame 402, and the outer frame 402
A plate 403, which is a material for the support plate, is placed on the upper part of the plate, and a vacuum is drawn from the suction port 404 of the outer frame 402 while heating the plate 403. As shown in h), the plate 403 sucks the surface 401 of the mold 49. And molded. The plate 403 hardens as the temperature decreases, and the support plate 405 as shown in i) is obtained by removing the plate 403 from the outer frame 402 and processing the central part and the peripheral part. This support plate 405
The shape of the surface 406 on one side corresponds to the shape of the surface 47 of the female die 48, and thus the surface shape of the peripheral portion of the stoma taken. An adhesive layer 407 is attached to the surface 406 of the support plate 405 with an adhesive as shown in j), and a release film 408 is further placed on the adhesive layer 407 to form a skin contact part of the ostomy appliance. A fitting part or a bag body can be attached to this skin part by various conventional methods to complete an ostomy appliance.

FIG. 5 shows another example of the manufacturing process of the support plate and the adhesive layer. As shown in a), ostomate 51 is laid down, and the circumference of stoma 52 is 12 cm in diameter and 2 cm in height.
A frame 53 made of aluminum is placed, and room temperature curing type silicone 54 is poured. In the case of urostomy, it is desirable to pack a thin rolled gauze or the like in the stoma to prevent silicone from flowing into the stoma. When the cured silicone is taken out from the frame 53, a mold 57 having a surface 56 that follows the surface shape of the peripheral portion 55 of the stoma 52 is obtained as shown in b). This female die 57 becomes a master die, and from this, a supporting plate 58 can be obtained as shown in c) in the same manner as described in FIG. 4, and its surface 59 corresponds to the surface shape of the stoma peripheral portion 55. There is. Next, an adhesive layer 501 and a release film 502 are provided as shown in d) in the same manner as in FIG.
A skin graft is obtained.

As the thermoplastic resin used for directly molding in the stoma, for example, a polyester resin can be used. An example is the product name Thermo Sprint manufactured by Alcare. The surface temperature of this surprint when taken out from hot water at 70 ° C is completely safe even if it comes into direct contact with the stoma. Room temperature curing type silicone is, for example, two-component RT manufactured by Shin-Etsu Chemical Co., Ltd.
V Silicone (KE-1309A, KE-1309B)
There is. Since this silicone has fluidity at room temperature, there is no problem in use. As a molding die made from the obtained master mold, plaster or a thermosetting resin mold can also be used. Further, the support plate can be molded not only by vacuum molding but also by general thermoforming or injection molding. As the material of the support plate, a material that can be heat-sealed with the fitting portion or the pouch is desirable, for example, P
Examples include E and EVA. Examples of materials for the adhesive layer include rubber-based compounds, acrylic compounds, compounds containing hydrocolloids, and examples thereof include JP-A-52-10079.
6, JP-A-54-3847, JP-A-54-4491.
JP-A-54-13693, JP-A-57-1694
14, JP-A-57-206436, JP-A-58-1.
The materials described in JP-A No. 03452 and JP-A No. 60-20976 can be used.

[0016]

EFFECTS OF THE INVENTION According to the present invention, it is possible to obtain a skin-contacting portion having a surface shape that precisely matches the surface shape, regardless of the surface shape of the stoma peripheral portion. There is no gap between the contact surface of the stoma and the skin surface around the stoma, and the skin opening does not close the stoma to expose the peripheral part of the stoma, which may cause a rash. Since there is no need to press the circumference of the stoma strongly as in the conventional case, there is no risk of pigmentation and keratinization, and it is possible to obtain an ostomy appliance that can respond to the unique shape of the stoma. it can.

[Brief description of drawings]

FIG. 1 is a sectional view of an embodiment of the present invention.

FIG. 2 is a cross-sectional view of the ostomy appliance shown in FIG. 1 attached to a stoma.

FIG. 3 is a cross-sectional view of another embodiment of the present invention.

FIG. 4 is an explanatory view showing steps of the manufacturing method of the present invention.

FIG. 5 is an explanatory view showing a step of another manufacturing method of the present invention.

[Explanation of symbols]

 1 Support Plate 2 Adhesive Layer 3 Opening 4 Release Film 5, 6 Fitting Part 7 Bag Body 8 Stoma 10 Stoma Peripheral Area 43 Thermoplastic Resin Plate 44 Hole 45 Hot Water 46 Stoma 47 Surface Along the Stoma Peripheral Surface 48 Female Mold 49 Male mold 401 Mold surface 402 Outer frame 403 Support plate material plate 404 Suction port 405 Support plate 406 Support plate surface 407 Adhesive layer 408 Peeling film 52 Stoma 53 Frame 54 Silicone 55 Peripheral part of stoma 56 Stoma Surface conforming to the surface shape of the peripheral portion 57 Female 58 Support plate 59 Support plate surface 501 Adhesive layer 502 Release film

Claims (4)

[Claims] 1. A male mold is molded from a female mold formed by molding with a thermoplastic resin on a peripheral part of a stoma, and a surface corresponding to a surface shape of the stoma peripheral part of a support plate molded from this male mold is provided. An ostomy appliance, wherein an adhesive layer is bonded to the entire surface of one side, and a bag for storing excrement is attached to the other side of the support plate. 2. A male mold is molded from a female mold formed around the stoma peripheral part by room temperature curing type silicone, and a surface corresponding to the surface shape of the stoma peripheral part of the support plate molded from this male mold is formed. An ostomy appliance, wherein an adhesive layer is bonded to the entire surface of the holding side, and a bag for storing excrement is attached to the other side of the support plate. 3. A thermoplastic resin plate is provided with a hole along the shape of the stoma at the center thereof, and the thermoplastic resin plate is heated to soften the stoma so that the stoma fits into the hole. The resin plate is cured by the temperature decrease to form a female mold, a male mold is molded from this female mold, and the male mold is used to mold a support plate corresponding to the shape of the stoma peripheral part. A method for manufacturing an ostomy appliance, wherein an adhesive layer is bonded to the entire surface on the side corresponding to the surface shape of the part, and a bag for storing excrement is attached to the other side of the support plate. 4. A mold surrounding the stoma is arranged around the stoma, and room temperature curable silicone is poured into the mold to be cured, and the cured silicone taken out from the mold is used as a female mold to mold a male mold. Then, using this male mold, a supporting plate corresponding to the shape of the stoma peripheral portion is formed, and an adhesive layer is bonded to the entire surface of the surface corresponding to the surface shape of the stoma peripheral portion of the supporting plate, and the other side of the supporting plate A method for manufacturing an ostomy appliance, wherein a bag for storing excrement is attached to the side of the body.