Mouthpiece for ostomy appliance and ostomy appliance

Abstract

To provide a mouth tool for a stoma appliance and the stoma appliance capable of easily and surely confirming the opening / closing of a flow path.SOLUTION: A mouth piece for an ostomy appliance includes a covered cylindrical part having a first opening on a side wall, a holding part for holding the covered cylindrical part rotatably around an axis of the covered cylindrical part and capable of opening and closing the first opening with rotation of the covered cylindrical part, and a projection part projecting from an outer surface of the covered cylindrical part. The stoma device includes the mouth tool 10 for the stoma device.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to an oral device for a stoma appliance and a stoma appliance, and in particular to an oral device for a stoma appliance used in a stoma appliance for temporarily storing excrement, excretory fluid, gas, exudate, secretions, etc. (hereinafter collectively referred to as "excrement"; the same applies hereinafter) from within a living body or on the surface of a living body, and a stoma appliance equipped with the oral device for a stoma appliance. [Background technology]

[0002] In cases where a person is unable to control fecal or urinary excretion at will, or where there is a disease of the digestive or urinary system, a surgical procedure may be performed to guide the intestines or ureters to the body surface, creating a stoma on the body surface. Those with a stoma must have an ostomy pouch attached to the stoma, which can temporarily store waste from the stoma. Additionally, people with openings or wounds on the body surface due to other diseases also need to have a drainage pouch attached around the opening or wound to handle waste discharged by drainage or other means.

[0003] The valves on the appliances attached to pouches of stoma appliances (e.g., ostomy pouches, drainage pouches, etc.) are operated near the lower abdomen. However, since people who have stomas and use stoma appliances are generally elderly, their eyesight and dexterity may be impaired, making it difficult to determine whether the valve is open or closed. Furthermore, these valves may be small and have unusual shapes, making it difficult to operate them correctly or to confirm whether the flow path is properly closed. Furthermore, if the flow path is not properly closed, there is a risk of excrement leaking from the pouch.

[0004] To address the above-mentioned problems, for example, Patent Document 1 proposes a valve for an ostomy pouch, which has a tactile indicator in a gripping area spaced from the valve body to indicate the position of the valve. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Special Publication No. 2013-543788 Summary of the Invention [Problem to be solved by the invention]

[0006] However, for example, the valve described in Patent Document 1 has room for improvement in terms of making it possible to more easily and reliably check whether the flow path is open or closed.

[0007] Therefore, a main object of the present invention is to provide an oral attachment for a stoma appliance that allows for easier and more reliable confirmation of whether a flow path is open or closed. [Means for solving the problem]

[0008] As a result of intensive research conducted by the present inventors to achieve the above-mentioned object, they have succeeded in developing an oral device for a stoma appliance that allows for easier and more reliable confirmation of whether the flow path is open or closed, and have completed the present invention.

[0009] The present invention provides a method for manufacturing a container, comprising: a holding part that holds the covered tubular part rotatably around the axis of the covered tubular part, and that can open and close the first opening as the covered tubular part rotates; a protrusion protruding from the outer surface of the covered cylindrical portion; The present invention provides a stoma appliance mouthpiece comprising: The protrusion may be an indicator that indicates whether the first opening is open or closed. The protrusion may protrude in a direction intersecting the axis. The holding portion may have a second opening that can be brought into engagement with the first opening as the covered cylindrical portion rotates. The protrusion may have a peak. The top may be uneven. The top portion may have a curved shape in side view. The convex portion may have a curvature in the shape in side view from the base end to the apex. The convex portion may have an anisotropic shape in plan view. The shape of the convex portion in plan view may have one axis of symmetry. The ratio of the maximum protrusion amount of the convex portion from the outer surface to the minimum outer diameter of the covered cylindrical portion may be more than 0% and not more than 50%. The ratio of the maximum width of the convex portion in the radial direction of the covered cylindrical portion to the minimum outer diameter of the covered cylindrical portion may be more than 0% and not more than 90%. The convex portion may have a drop-shaped planar shape. The shape of the convex portion in plan view may be an arrow shape. The protrusion may have a plurality of separate portions that protrude from the outer surface. The covered cylindrical portion and the protruding portion may be integrally formed. The stoma appliance mouthpiece may further include handles protruding from both sides of the capped tubular portion that sandwich the protruding portion when viewed from the protruding direction of the protruding portion. The covered cylindrical portion, the protruding portion, and the handle may be integrally formed. The present invention provides a pouch for containing waste from a stoma; a stoma appliance mouthpiece attached to the pouch; Also provided is a stoma appliance comprising: [Effects of the Invention]

[0010] According to the present invention, it is possible to more easily and reliably check whether a flow path is open or closed. Note that the effects described herein are not necessarily limited to those described herein, and may be any of the effects described in the present disclosure. [Brief explanation of the drawings]

[0011] [Figure 1] FIG. 1 is a front view of a closed state of an oral appliance for an ostomy appliance according to a first embodiment of the present invention. [Figure 2] FIG. 1 is a rear view of the stoma appliance oral appliance according to the first embodiment of the present invention in a closed state. [Figure 3] FIG. 2 is a perspective view of a covered tubular part of the stoma appliance oral appliance of FIG. 1. [Figure 4] FIG. 2 is a perspective view of a holding part of the stoma appliance oral appliance of FIG. 1. [Figure 5] FIG. 2 is an exploded perspective view of the stoma appliance fitting of FIG. 1. [Figure 6] Fig. 6A is a perspective view of the stoma appliance oral appliance of Fig. 1 in a closed state, and Fig. 6B is a perspective view of the stoma appliance oral appliance of Fig. 1 in an open state. [Figure 7] FIG. 2 is a front view of the stoma appliance oral appliance of FIG. 1 in a closed state. [Figure 8] FIG. 2 is a rear view of the stoma appliance oral appliance of FIG. 1 in a closed state. [Figure 9] FIG. 2 is a left side view of the stoma appliance oral appliance of FIG. 1 in a closed state. [Figure 10] FIG. 2 is a right side view of the stoma appliance oral appliance of FIG. 1 in a closed state. [Figure 11] FIG. 2 is a plan view of the stoma appliance oral appliance of FIG. 1 in a closed state. [Figure 12] FIG. 2 is a bottom view of the stoma appliance oral appliance of FIG. 1 in a closed state. [Figure 13] FIG. 10 is a front view of a closed state of an oral appliance for stoma appliance according to a second embodiment of the present invention. [Figure 14] FIG. 10 is a front view of a closed state of an oral appliance for an ostomy appliance according to a third embodiment of the present invention. [Figure 15] FIG. 10 is a front view of a closed state of an oral appliance for a stoma appliance according to a fourth embodiment of the present invention. [Figure 16] FIG. 10 is a front view of the stoma appliance oral appliance according to the fifth embodiment of the present invention in a closed state. [Figure 17] FIG. 10 is a front view of an ostomy appliance according to a sixth embodiment of the present invention. [Figure 18] FIG. 10 is a diagram showing user evaluations of the stoma appliance oral appliances according to each embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0012] A preferred embodiment for carrying out the present invention will be described below. The embodiment described below shows an example of a typical embodiment of the present invention, and the scope of the present invention should not be construed as being narrow.

[0013] <1. Oral device for stoma appliance according to the first embodiment> FIG. 1 is a front view of the stoma appliance oral device according to the first embodiment of the present invention in a closed state. FIG. 2 is a back view of the stoma appliance oral device according to the first embodiment of the present invention in a closed state. FIG. 3 is a diagram showing the configuration of a covered tubular portion of the stoma appliance oral device of FIG. 1. FIG. 4 is a diagram showing the configuration of a holding portion of the stoma appliance oral device of FIG. 1. FIG. 5 is an exploded perspective view of the stoma appliance oral device of FIG. 1. FIG. 6A is a perspective view of the stoma appliance oral device of FIG. 1 in a closed state. FIG. 6B is a perspective view of the stoma appliance oral device of FIG. 1 in an open state. FIG. 7 is a front view of the stoma appliance oral device of FIG. 1 in a closed state. FIG. 8 is a back view of the stoma appliance oral device of FIG. 1 in a closed state. FIG. 9 is a left side view of the stoma appliance oral device of FIG. 1 in a closed state. FIG. 10 is a right side view of the stoma appliance oral device of FIG. 1 in a closed state. FIG. 11 is a plan view of the stoma appliance oral device of FIG. 1 in a closed state. 12 is a bottom view of the stoma appliance oral appliance of FIG. 1 in a closed state.

[0014] The stoma appliance appliance 10 according to the first embodiment of the present invention is an appliance used in a stoma appliance including, for example, an ostomy pouch, a drainage pouch, a feces bag, a urine collection bag, a urine collection bag, etc. Stoma appliances are also called "excrement collection appliances."

[0015] 1, 2, etc., will be referred to as "up" and "down" for convenience in the following description. As shown in Figures 1 and 2, the stoma appliance oral device 10, for example, comprises a covered tubular portion 11, a holding portion 12 that holds the covered tubular portion 11 rotatably around the axis of the covered tubular portion 11, and a protrusion 13 that protrudes from the outer surface of the covered tubular portion 11. The stoma appliance oral device 10 further comprises an operating portion 14 provided on the outer surface of the covered tubular portion 11.

[0016] As an example, the covered cylindrical portion 11, the protruding portion 13, and the operating portion 14 are integrally molded by resin molding (see FIG. 3). As an example, the holding portion 12 is integrally molded by resin molding (see FIG. 4).

[0017] One axial end (lower end) of the covered tubular portion 11 is an open end that serves as an outlet for the stoma appliance oral device 10, and the other axial end (upper end) is a closed end. The covered tubular portion 11 is held by the holding portion 12 so that it can rotate (slide) around its axis while its axial movement is restricted. If necessary, a discharge pipe is connected to the open end (lower end) of the covered tubular portion 11.

[0018] The capped cylindrical portion 11 is capped cylindrical and has a cylindrical first portion 11a including an open end (lower end), a capped cylindrical second portion 11b including a closed end (upper end), and a cylindrical third portion 11c located between the first portion 11a and the second portion 11b, the third portion 11c having a first opening 11c1 in its side wall.

[0019] The holding part 12 is attached (specifically, tightly fixed) to the outlet of the pouch of the stoma appliance (hereinafter also referred to as the "pouch outlet") (see FIG. 17). The holding part 12 has a receiving part 12a located on the side of the tubular capped part 11 to receive excrement in the pouch of the stoma appliance, a cylindrical opening / closing part 12b into which the third part 11c of the tubular capped part 11 is inserted (specifically, press-fitted) and which can open and close the first opening 11c1 as the tubular capped part 11 rotates, and a cap part 12c that covers the second part 11b of the tubular capped part 11. The holding part 12 further has a pair of attachment pieces 12d, 12e on both ends of the tubular capped part 11 in a direction perpendicular to the axial direction. The pair of attachment pieces 12d, 12e can be individually attached to a pair of attachment grooves provided around the periphery of the pouch outlet. At least the third portion 11c of the capped tubular portion 11 is also called the "stem," and at least the opening / closing portion 12b of the holding portion 12 is also called the "valve body." In other words, the stoma appliance oral device 10 has a valve that is composed of a stem and a valve body and opens and closes the flow path.

[0020] The second portion 11b of the capped cylindrical portion 11 has a cylindrical portion 11b1, a constricted portion 11b2 that is continuous with the cylindrical portion 11b1 and inserted into a hole 12c1 provided at the upper end of the cap portion 12c, and a slip-out prevention portion 11b3 that is continuous with the constricted portion 11b2 and located outside the cap portion 12c.

[0021] The open-close portion 12b of the holder 12 has a second opening 12b1 that can move relative to (preferably face directly opposite to) the first opening 11c1 as the covered cylindrical portion 11 rotates (see FIGS. 1 to 5). The second opening 12b1 is located at the same position as the first opening 11c1 in the axial direction of the covered cylindrical portion 11. The second opening 12b1 preferably has the same shape and size as the first opening 11c1. When the valve is in a closed state (see FIG. 6A), the first opening 11c1 of the covered cylindrical portion 11 is located on the opposite side to the second opening 12b1 of the open-close portion 12b and is closed (sealed) by the inner circumferential surface of the open-close portion 12b, and the second opening 12b1 of the open-close portion 12b is closed (sealed) by the outer circumferential surface 11c2 of the third portion 11c of the covered cylindrical portion 11 on the opposite side to the first opening 11c1. When the covered cylindrical portion 11 is rotated 180° relative to the holder 12 from the closed state (see FIG. 6A), the valve enters an open state (see FIG. 6B) in which the second opening 12b1 faces (more specifically, directly faces) the first opening 11c1. When the covered cylindrical portion 11 is rotated 180° relative to the holder 12 from the open state (see FIG. 6B), the valve enters a closed state (see FIG. 6A). Note that the valve is essentially closed when the covered cylindrical portion 11 is rotated, for example, 100° or more relative to the holder 12 from the open state. However, to prevent a rotational force from acting on the operating portion 14 unexpectedly from the closed state to cause the valve to enter a half-open or open state (to ensure a sufficient margin between the open state and the closed state), the state in which the covered cylindrical portion 11 is rotated 180° relative to the holder 12 from the open state is defined as the closed state.

[0022] The second opening 12b1 communicates with the receiving portion 12a (see FIGS. 6A and 6B). The receiving portion 12a is a container-like structure with no lid that opens upward. The receiving portion 12a has guide portions 12a1 (for example, stepped inclined surfaces that slope downward toward the second opening 12b1) on the side surface and bottom surface facing the second opening 12b1, which guide the excrement in the pouch of the stoma appliance to the second opening 12b1 (see FIGS. 1 and 2).

[0023] When the valve is in a closed state, excrement in the pouch of the stoma appliance is prevented from flowing from the receiving portion 12a into the covered tubular portion 11. When the valve is in an open state, the first opening 11c1 and the second opening 12b1 face each other, connecting the inside of the receiving portion 12a to the inside of the covered tubular portion 11, and excrement flows from the receiving portion 12a through the second opening 12b1 and the first opening 11c1 into the covered tubular portion 11. The excrement that flows into the covered tubular portion 11 flows toward the open end (lower end) of the covered tubular portion 11 and is discharged from the open end directly or via a discharge pipe attached to the open end into, for example, an excrement collection container, a toilet, etc.

[0024] The operating unit 14 has handles protruding from both sides of the convex portion 13 of the covered tubular portion 11 when viewed from the protruding direction of the convex portion 13 (a direction perpendicular to the plane of FIG. 1). More specifically, the operating unit 14 has a first handle 14a protruding in the radial direction of the covered tubular portion 11 from one side surface of the first portion 11a of the covered tubular portion 11 in a direction perpendicular to both the protruding direction of the convex portion 13 and the axial direction of the covered tubular portion 11, and a second handle 14b protruding in the radial direction of the covered tubular portion 11 from the other side surface of the first portion 11a of the covered tubular portion 11 in a direction perpendicular to both the protruding direction of the convex portion 13 and the axial direction of the covered tubular portion 11 (more specifically, the surface opposite to the one side surface). A user can rotate the covered tubular portion 11 and open or close the valve even with a small force by pinching the first and second handles 14a, 14b with their fingers to apply a rotational moment to the operating unit 14. As an example, each handle has a generally elliptical plate shape with its thickness oriented in the direction of protrusion of the convex portion 13. Here, the second handle 14b is larger than the first handle 14a, but the first handle 14a may be larger than the second handle 14b, or the first and second handles 14a, 14b may be the same size. The shape and size of each handle can be changed as appropriate.

[0025] As an example, the first and second handles 14a, 14b each have a flat surface on the side of the convex portion 13 (see FIG. 1), and have concave portions 14a1, 14b1 on the side opposite the convex portion 13 (see FIG. 2). This makes it possible to more reliably check the opening and closing of the valve by checking the position of the concave portion of each handle in addition to checking the position of the convex portion 13.

[0026] Although the operating part 14 is not essential, as described above, it is very effective for improving the rotational operability of the covered tubular part 11. The operating part 14 may have only one of the first and second handles 14a, 14b.

[0027] The protrusion 13 protrudes from the outer surface of the first part 11a of the covered cylindrical part 11 and functions as an indicator (mark) (indicating the open / closed state of the first opening 11c1) for confirming whether the valve is in a closed state (see FIG. 6A) or an open state (see FIG. 6B). The protrusion 13 protrudes in a direction intersecting (e.g., perpendicular to) the axis of the covered cylindrical part 11. In other words, the protruding direction of the protrusion 13 is a direction intersecting (e.g., perpendicular to) the axis of the covered cylindrical part 11. The protrusion 13 is also called a "protrusion indicator" or a "protrusion mark."

[0028] The protrusion 13 rotates around the axis of the covered tubular portion 11 together with (integrally with) the covered tubular portion 11 in response to the rotation of the covered tubular portion 11 around the axis relative to the holding portion 12. The protrusion 13 is located on the side of the user of the stoma appliance (hereinafter also simply referred to as "user") when the valve is in a closed state, and is located on the opposite side from the user when the valve is in an open state. This allows the user to easily and reliably check whether the valve is in a closed or open state (check whether the valve is open or closed) simply by recognizing the position of the protrusion 13 by touch or sight.

[0029] By having the protrusion 13 protrude from the outer surface of the covered cylindrical portion 11, the position of the protrusion 13 in the direction perpendicular to the axial direction of the covered cylindrical portion 11 does not change significantly even when the covered cylindrical portion 11 rotates (it is always on the outer surface of the covered cylindrical portion 11), which prevents the user from losing track of the location of the protrusion 13. In contrast, if the protrusion 13 were protruded from the handle, the position of the protrusion 13 in the direction perpendicular to the axial direction of the covered cylindrical portion 11 would change significantly, which could cause the user to lose track of the location of the protrusion 13 and have difficulty checking whether the valve is open or closed.

[0030] Furthermore, since the protrusion 13 is not provided on the handle but on the outer surface of the covered cylindrical portion 11, the protrusion-type indicator can be provided regardless of the presence or absence of the operating portion 14. Note that by increasing the protrusion amount of the protrusion 13 to a certain extent, the protrusion 13 may function as a handle in addition to the indicator function. In this case, at least one of the first and second handles 14a, 14b may be omitted.

[0031] As an example, the protrusions 13 have a top, which allows the user to reliably recognize the position of the protrusions 13 by a unique sensation (tactile sensation) when touching the top of the protrusions 13.

[0032] As an example, the tops of the protrusions 13 are uneven. This increases the stimulus felt when the user touches the tops of the protrusions 13, allowing the user to more reliably recognize the positions of the protrusions 13.

[0033] The top of the protrusion 13 has a curved shape in a side view, which prevents the user from feeling strange or uncomfortable when touching the top of the protrusion 13.

[0034] The shape of the protrusion 13 from the base end to the apex has a curvature in side view. As a result, the entire protrusion 13 is made up of a curved surface, so that the user is prevented from feeling any discomfort or strangeness when touching any part of the protrusion 13.

[0035] The shape of the protrusion 13 in plan view is anisotropic. This makes it possible to make a stronger impression on the user by touch and sight of the shape characteristics of the protrusion 13 than if the shape in plan view were isotropic, allowing the user to stably and reliably check whether the valve is open or closed.

[0036] The shape of the protrusion 13 in a plan view has one axis of symmetry, which makes it easier for the user to recognize the up, down, left, right, etc. of the protrusion 13, and therefore makes it easier for the user to recognize the orientation of the covered tubular portion 11 (especially the up and down direction).

[0037] The shape of the protrusion 13 in a plan view is drop-shaped. More specifically, the shape of the protrusion 13 in a plan view is drop-shaped with the apex at the top. This makes it possible to more strongly impress the user with the shape characteristics of the protrusion 13 and also makes it easier for the user to recognize the orientation (particularly the up-down direction) of the covered tubular portion 11. Because the shape of the protrusion 13 in a plan view is drop-shaped, the user can intuitively recognize the protrusion 13 as an indicator showing whether the valve is open or closed, even if they do not know in advance that the protrusion 13 is an indicator.

[0038] Here, the protrusions 13 have a rounded, three-dimensional drop shape, which allows the protrusions 13 to function as indicators while suppressing any discomfort or strange feeling that the user may have when touching the protrusions 13.

[0039] Minimum outer diameter OD of the covered cylindrical portion 11 min The maximum protrusion PA of the protrusion 13 from the outer surface of the covered cylindrical portion 11 max The ratio of the maximum protrusion amount PA (see FIG. 9) is preferably more than 0% and not more than 50%, more preferably 10% to 40%, and even more preferably 20% to 30%. max If it is too large, it becomes a hindrance, and if it is too small, it becomes difficult to recognize. max is preferably large enough to function as an indicator.

[0040] Minimum outer diameter OD of the covered cylindrical portion 11min The maximum width W of the protrusion 13 in the radial direction of the covered cylindrical portion 11 max The ratio of the maximum width W (see FIG. 1) is preferably more than 0% and not more than 90%, more preferably 10% to 80%, more preferably 20% to 70%, and even more preferably 30% to 60%. max If it is too wide, it becomes an obstacle, and if it is too narrow, recognition decreases. max is preferably large enough to function as an indicator.

[0041] The stoma appliance oral device 10 of the first embodiment described above comprises a capped tubular portion 11 having a first opening 11c1 on its side wall, a holding portion 12 that holds the capped tubular portion 11 rotatably around the axis of the capped tubular portion 11 and that can open and close the first opening 11c1 as the capped tubular portion 11 rotates, and a protrusion 13 that protrudes from the outer surface of the capped tubular portion 11.

[0042] This makes it possible to provide an oral attachment for a stoma appliance that allows for easier and more reliable confirmation of whether the flow path is open or closed.

[0043] <2. Ostomy appliance mouthpiece according to the second embodiment> Fig. 13 is a front view of the stoma appliance oral device 20 according to the second embodiment of the present invention in a closed state. As shown in Fig. 13, the stoma appliance oral device 20 has the same configuration as the stoma appliance oral device 10 according to the first embodiment, except that the convex portion 13 is curved and flat.

[0044] In the stoma appliance mouthpiece 20, the convex portion 13 has a drop-shaped shape when viewed in a plan view, and a curved, flat drop-shaped shape when viewed from the axial direction of the capped tubular portion 11, which is a flat shape curved along the outer peripheral surface of the capped tubular portion 11.

[0045] According to the stoma appliance oral device 20, the convex portion 13 is curved and flat, so that it is less irritating to the user when touched and is slightly less recognizable than the stoma appliance oral device 10 of the first embodiment, but it can achieve roughly the same effect as the stoma appliance oral device 10 of the first embodiment.

[0046] <3. Ostomy appliance mouthpiece according to the third embodiment> 14 is a front view of the stoma appliance oral device 30 according to the third embodiment of the present invention in a closed state. The stoma appliance oral device 30 has the same configuration as the stoma appliance oral device 10 according to the first embodiment, except that the protruding portion 13 has multiple (e.g., three) portions 13a that are separated from one another and protrude from the outer surface of the capped tubular portion 11.

[0047] Each of the multiple sections 13a of the convex portion 13 has a rounded, three-dimensional teardrop shape. Each section 13a is smaller than the stoma appliance oral device 10. Here, the three sections 13a are arranged on the outer surface of the first section 11a of the covered tubular portion 11 so as to form three vertices of an isosceles triangle (e.g., an equilateral triangle) with its base pointing downward. The multiple sections 13a may be, for example, two sections 13a or four or more sections 13a. When the multiple sections 13a are four or more sections 13a, the sections 13a may be arranged at the vertices of a polygon, for example. Each section 13a may have another shape, such as a curved, flattened teardrop shape. The multiple sections 13a may have shapes different from each other.

[0048] According to the stoma appliance oral device 30, the convex portion 13 has multiple small portions 13a, which stimulate multiple points on the user when the user touches it, making it easy to recognize and providing effects roughly similar to those of the stoma appliance oral device 10 of the first embodiment.

[0049] <4. Oral device for stoma appliance according to the fourth embodiment> Fig. 15 is a front view of the stoma appliance oral device 40 according to the fourth embodiment of the present invention in a closed state. As shown in Fig. 15, the stoma appliance oral device 40 has a configuration generally similar to the stoma appliance oral device 10 according to the first embodiment, except that the convex portion 13 has an arrow-shaped planar shape.

[0050] In the stoma appliance mouthpiece 40, the convex portion 13 has a curved, flat, downward arrow shape when viewed from the axial direction of the covered tubular portion 11, which is curved along the outer peripheral surface of the covered tubular portion 11.

[0051] According to the stoma appliance oral device 40, the convex portion 13 is curved and flat, so it is slightly less irritating to the user when touched compared to the stoma appliance oral device 10 of the first embodiment, but because the convex portion 13 is arrow-shaped, the direction of the capped tubular portion 11 (particularly the up and down direction) can be reliably recognized, and roughly the same effect as the stoma appliance oral device 10 of the first embodiment can be obtained.

[0052] In the stoma appliance oral device 40, the convex portion 13 may be, for example, in the shape of a rounded three-dimensional arrow.

[0053] <5. Ostomy appliance mouthpiece according to the fifth embodiment> Fig. 16 is a front view of the stoma appliance oral device 50 according to the fifth embodiment of the present invention in a closed state. As shown in Fig. 16, the stoma appliance oral device 50 has the same configuration as the stoma appliance oral device 10 according to the first embodiment, except that the convex portion 13 is hemispherical.

[0054] According to the stoma appliance oral device 50, the convex portion 13 is hemispherical, so compared to the stoma appliance oral device 10, it is less recognizable in terms of shape and direction when touched by the user, but it provides roughly the same effect as the stoma appliance oral device 10 of the first embodiment.

[0055] In the stoma appliance oral device 50, the convex portion 13 may be, for example, in the shape of a curved flat truncated cone or a polygonal truncated pyramid that curves along the outer peripheral surface of the covered tubular portion 11.

[0056] <6. Stoma appliance according to the sixth embodiment> 17 is a front view of a stoma appliance according to a sixth embodiment of the present invention. The stoma appliance 2000 according to the sixth embodiment includes, for example, a pouch 2010 that stores waste from the stoma, and a stoma appliance attachment 10 that is attached to the pouch 2010.

[0057] The stoma appliance 2000 may include, for example, an ostomy pouch, a drainage pouch, a fecal bag, a urine collection bag, a urine collection bag, etc. as the pouch 2010. The stoma appliance 2000 is worn by a user with the back side facing away from the user and the front side facing the user.

[0058] The pouch 2010 is formed into a sealed bag shape using plastic film, and has a base plate 2020 attached to the top. The base plate 2020 is attached to the user's stoma (constructed opening) via its adhesive layer, and waste is discharged into the pouch 2010 through the opening 2030 in the base plate.

[0059] As described above, the holding part 12 of the stoma appliance oral device 10 is tightly fixed by welding or the like to the inside of the pouch outlet (lower end) provided in the pouch 2010 for discharging excrement.

[0060] (User Rating) User evaluations, which are evaluations by users who have actually used the stoma appliance oral appliances according to each embodiment of the present invention, will be described below with reference to Fig. 17. The user evaluations were conducted by multiple users (for example, four users).

[0061] In FIG. 17, the evaluation items are the recognizability of the convex mark as an indicator when the user uses the stoma appliance oral appliance without prior explanation about the convex mark (convex indicator) and after explanation.

[0062] As shown in Figure 17, the majority of users rated the stoma appliance appliances 10 and 20 according to the first and second embodiments as extremely easy to recognize without prior explanation (◎), and rated them as easy to recognize after explanation (◯). In other words, the stoma appliance appliances 10 and 20 according to the first and second embodiments are intuitively recognizable by users, reducing the need for prior explanation. Additionally, many users commented that the convex portion 13 (three-dimensional drop-shaped) of the stoma appliance appliance 10 according to the first embodiment has an impactful shape and a pleasant, stimulating feel on the skin, demonstrating its highly suitable use as a visually and tactile indicator. The convex portion 13 (flat drop-shaped) of the stoma appliance appliance 20 according to the second embodiment is also highly suitable as a visually and tactile indicator, although it is slightly inferior to the stoma appliance appliance 10 according to the first embodiment.

[0063] 17, the stoma appliance oral device 30 according to the third embodiment was rated as "good" by the majority of users as being easily recognizable without prior explanation, and was also rated as "good" by the majority of users as being easily recognizable after explanation. In other words, it can be seen that the stoma appliance oral device 30 according to the third embodiment can be recognized by users regardless of whether prior explanation is given or not.

[0064] 17, the majority of users evaluated the stoma appliance appliance 40 according to the fourth embodiment as being unable to recognize it without prior explanation (×), but the majority of users evaluated it as being extremely easy to recognize after explanation (◎). In other words, it can be seen that the stoma appliance appliance 40 according to the fourth embodiment can be sufficiently recognized by users with prior explanation.

[0065] 17, the majority of users evaluated the stoma appliance appliance 50 according to the fifth embodiment as being unable to recognize it without prior explanation (×), but the majority of users evaluated it as being able to recognize it to some extent after explanation (△). In other words, it can be seen that the stoma appliance appliance 50 according to the fifth embodiment can be recognized to some extent by users if they are given prior explanation.

[0066] The present invention is not limited to the above-described embodiments. For example, the shape, size, arrangement, etc. of the protrusion 13 can be changed as appropriate within the range in which it functions as an indicator showing whether the valve is open or closed.

[0067] The present invention can also have the following configuration. (1) a covered cylindrical portion having a first opening in a side wall; a holding part that holds the covered tubular part rotatably around the axis of the covered tubular part, and that can open and close the first opening as the covered tubular part rotates; a protrusion protruding from the outer surface of the covered cylindrical portion; A stoma appliance mouthpiece comprising: (2) The stoma appliance oral device according to (1), wherein the protrusion is an indicator that shows the open / closed state of the first opening. (3) The stoma appliance mouthpiece according to (1) or (2), wherein the convex portion protrudes in a direction intersecting the axis. (4) The stoma appliance oral device according to any one of (1) to (3), wherein the holding portion has a second opening that can be made to face the first opening as the covered tubular portion rotates. (5) The stoma appliance oral device according to any one of (1) to (4), wherein the convex portion has a peak. (6) The stoma appliance according to (5), wherein the top is not flat. (7) The stoma appliance mouthpiece according to (5) or (6), wherein the top portion has a curved shape when viewed from the side. (8) The stoma appliance oral device according to any one of (5) to (7), wherein the convex portion has a curvature in a side view from the base end to the apex. (9) The stoma appliance oral device according to any one of (1) to (8), wherein the convex portion has an anisotropic shape in a plan view. (10) The stoma appliance oral device according to any one of (1) to (9), wherein the shape of the convex portion in plan view has one axis of symmetry. (11) An oral device for a stoma appliance described in any one of (1) to (10), wherein the ratio of the maximum protrusion amount of the convex portion from the outer surface to the minimum outer diameter of the capped tubular portion is more than 0% and not more than 50%. (12) A stoma appliance mouthpiece according to any one of (1) to (11), wherein the ratio of the maximum radial width of the convex portion to the minimum outer diameter of the capped tubular portion is greater than 0% and not more than 90%. (13) The stoma appliance oral device according to any one of (1) to (12), wherein the convex portion has a drop-shaped planar shape. (14) The stoma appliance oral device according to any one of (1) to (12), wherein the convex portion has an arrow-shaped planar shape. (15) The stoma appliance oral device according to any one of (1) to (14), wherein the protrusion has a plurality of portions protruding from the outer surface. (16) The stoma appliance oral device according to any one of (1) to (15), wherein the capped tubular portion and the protruding portion are integrally formed. (17) A stoma appliance mouthpiece according to any one of (1) to (16), further comprising a handle protruding from each of both sides of the capped tubular portion that sandwich the protrusion, as viewed from the protruding direction of the protrusion. (18) The stoma appliance mouthpiece according to (17), wherein the capped tubular portion, the protruding portion, and the handle are integrally molded. (19) A pouch for receiving waste from the stoma; The stoma appliance mouthpiece according to any one of (1) to (18) is attached to the pouch; and A stoma appliance comprising: [Explanation of symbols]

[0068] 10, 20, 30, 40, 50, 60: Ostomy appliance mouthpiece 11: Covered cylinder part 11c1: 1st opening 12: Holding part 12b1: 2nd opening 13: Convex part 14a: First handle 14b: Second handle 2000: Stoma appliance 2010: Pouch W max :Maximum width OD min :Minimum outer diameter PA max :Maximum protrusion amount

Claims

1. a covered cylindrical portion having a first opening in a side wall; a holding part that holds the covered tubular part rotatably around an axis of the covered tubular part, and that can open and close the first opening in accordance with the rotation of the covered tubular part; a protrusion protruding from the outer surface of the covered cylindrical portion; A stoma appliance mouthpiece comprising:

2. The stoma appliance according to claim 1 , wherein the protrusion is an indicator that shows whether the first opening is open or closed.

3. The stoma appliance according to claim 1 , wherein the protrusion protrudes in a direction intersecting with the axis.

4. The stoma appliance according to claim 1, wherein the holding portion has a second opening that can be made to face the first opening as the covered tubular portion rotates.

5. The stoma appliance according to claim 1 , wherein the protrusion has a peak.

6. The stoma appliance according to claim 5, wherein the top portion is non-flat.

7. The stoma appliance according to claim 5, wherein the top portion has a curved shape when viewed from the side.

8. The stoma appliance oral device according to claim 5, wherein the protruding portion has a curvature in a side view from the base end to the apex.

9. The stoma appliance according to claim 1, wherein the convex portion has an anisotropic shape in a plan view.

10. The stoma appliance according to claim 1, wherein the convex portion has a shape with one axis of symmetry in a plan view.

11. The stoma appliance according to claim 1, wherein the ratio of the maximum protrusion amount of the convex portion from the outer surface to the minimum outer diameter of the capped tubular portion is greater than 0% and not more than 50%.

12. The stoma appliance according to claim 1, wherein the ratio of the maximum radial width of the convex portion to the minimum outer diameter of the capped tubular portion is greater than 0% and not more than 90%.

13. The stoma appliance oral device according to any one of claims 1 to 12, wherein the convex portion has a drop-shaped planar shape.

14. The stoma appliance oral device according to any one of claims 1 to 12, wherein the convex portion has an arrow-shaped planar shape.

15. The stoma appliance oral device according to any one of claims 1 to 12, wherein the convex portion has a plurality of portions separated from one another that protrude from the outer surface.

16. The stoma appliance oral device according to any one of claims 1 to 12, wherein the capped tubular portion and the protruding portion are integrally formed.

17. The stoma appliance according to any one of claims 1 to 12, further comprising a handle protruding from at least one of both sides of the capped tubular portion that sandwich the protrusion when viewed from the protruding direction of the protrusion.

18. The stoma appliance according to claim 17, wherein the capped tubular portion, the protruding portion, and the handle are integrally formed.

19. a pouch for receiving waste from the stoma; The stoma appliance according to any one of claims 1 to 12, which is attached to the pouch; A stoma appliance comprising:

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