Faceplate for an ostomy appliance and an ostomy appliance

Abstract

To provide a face plate and a stoma device having the face plate, capable of suppressing wrinkles generated around a stoma caused by body movement when living with the stoma device mounted, and reducing surface pressure generated in a mounting part with which the face plate is brought into contact.SOLUTION: The present invention relates to a face plate 100 for an ostomy appliance and an ostomy appliance comprising the face plate, the face plate comprising a flat plate 10 having a first opening, a skin protective agent 20 having a second opening, and a stoma insertion hole at least composed of the first opening and the second opening, wherein a plate end in a center direction of the flat plate is located within a range of a same or adjacent region outward from the second opening.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to a face plate for a stoma appliance used in an excrement collection appliance for temporarily storing excrement, discharged fluid, gas, exudate, secretions, etc. (hereinafter collectively referred to as "excrement"; the same applies hereinafter) excreted from an excretory opening created in the human body, and to a stoma appliance equipped with the same. [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 need to have a pouch attached to the stoma that can temporarily store waste from the stoma. People who have openings or wounds on the surface of their body due to other diseases also need a pouch attached around the opening or wound to handle waste discharged by drainage or other means.

[0003] For example, Patent Document 1 discloses an excrement collection device comprising a skin-adhering member that is adhesively fixed around an opening in a living body, a ring-shaped first flange fixed to the non-skin-adhering side of the skin-adhering member, and a ring-shaped second flange that can fit into the first flange, wherein the skin-adhering member has an opening that corresponds to the opening in the living body, and either the first flange or the second flange has a ring-shaped protrusion made of a hard resin material, and the other flange has a fitting device that has a ring-shaped grooved protrusion made of hard resin that can fit into the ring-shaped protrusion. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2006-141701 Summary of the Invention [Problem to be solved by the invention]

[0005] When wearing a stoma appliance, ostomates are concerned about leakage due to wrinkles around the stoma caused by body movements, and the surface pressure generated by the base plate on the contact area (especially the abdomen) is uncomfortable, which are undesirable. However, attempts to achieve both of these goals have not been sufficient.

[0006] Therefore, the main object of the present invention is to provide a base plate and a stoma appliance including the base plate, which can suppress wrinkles that occur around the stoma due to body movements when wearing the stoma appliance and can reduce the surface pressure that occurs at the attachment part where the base plate comes into contact when living with the stoma appliance. [Means for solving the problem]

[0007] The present invention relates to a flat plate having a first opening; a skin barrier having a second opening; a stoma insertion hole composed of at least the first opening and the second opening; Equipped with A second opening is located within the first opening of the planar plate. A faceplate for a stoma appliance can be provided. The present invention relates to a flat plate having a first opening; a skin barrier having a second opening; a stoma insertion hole composed of at least the first opening and the second opening; Equipped with The plate edge toward the center of the flat plate is located within the same or adjacent area outward from the second opening. A faceplate for a stoma appliance can be provided.

[0008] The range of the same or adjacent region may be within a range of 1 to 1.4 times the diameter of the second opening. The plate width of the flat plate may be greater than 15 mm. The material of the flat plate may be a thermoplastic resin. The plate bending stress in the face plate may be 2N or more and 30N or less.

[0009] The present invention provides a base plate for a stoma appliance, a storage section that is connected to the base plate and that stores waste from the stoma; It is possible to provide a stoma appliance comprising:

[0010] The diameter of the first opening of the flat plate may be larger than the diameter of the second opening and smaller than the diameter of the third opening of the storage section that stores waste from the stoma. [Effects of the Invention]

[0011] According to the present invention, it is possible to provide a face plate and a stoma appliance including the face plate, which can suppress wrinkles that occur around the stoma due to body movements when wearing the stoma appliance and can reduce the surface pressure that occurs at the attachment part where the face plate comes into contact when the stoma appliance is worn. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1A shows a rear view (viewed from the pouch side that contacts the pouch), FIG. 1B shows a front view (viewed from the side that contacts the skin protective agent (e.g., the ventral side)), and FIG. 1C shows a side view showing an example of the configuration of a flat plate used in a base plate for a stoma appliance according to one embodiment of the present invention, but the present invention is not limited to this. [Figure 2] FIG. 1 is a rear view (viewed from the pouch side) showing an example of the configuration of a base plate made up of a flat plate and a skin protective agent according to one embodiment of the present invention, but the present invention is not limited to this. [Figure 3] FIG. 1 is a front view (viewed from the side that is attached to the abdomen or the side where the base plate is located (e.g., the abdominal side)) showing an example of the configuration of a stoma appliance according to one embodiment of the present invention, but the present invention is not limited to this. [Figure 4] 1 is a cross-sectional view (left side) taken along line XX' when the stoma appliance (FIG. 2) according to one embodiment of the present invention is attached to the stoma portion, but the present invention is not limited to this. DETAILED DESCRIPTION OF THE INVENTION

[0013] Preferred embodiments for carrying out the present invention will be described below with reference to the drawings. Note that the embodiment described below shows an example of a typical embodiment of the present invention, and the scope of the present invention is not limited thereto. Furthermore, the present invention can be achieved by arbitrarily or appropriately combining any of the techniques, embodiments, examples, and modifications described in this specification.

[0014] In the following description of the embodiments, configurations may be described using terms including "approximately," such as "approximately parallel" and "approximately perpendicular." For example, "approximately parallel" does not only mean completely parallel, but also means substantially parallel, that is, including a state in which the configuration is deviated from the completely parallel state by, for example, a few percent (which may be "°" or "mm") (for example, a deviation within a range of 0.05, 0.1, 0.5, 1, 2, or 3% or less). The same applies to other terms including "approximately." Furthermore, each drawing is a schematic diagram and is not necessarily an exact illustration.

[0015] Unless otherwise specified, in the drawings, "upper" means the upper direction or upper side in the drawing, "lower" means the lower direction or lower side in the drawing, "left" means the left direction or left side in the drawing, and "right" means the right direction or right side in the drawing. Furthermore, in the drawings, the same or equivalent elements or members are given the same reference numerals, and redundant explanations are omitted. Furthermore, in the present invention, one or more types selected from these may be used for the examples described in this specification.

[0016] 1. Background and Overview of the Invention The present inventors focused on the fact that, when ostomates wear a stoma appliance, body movements can cause wrinkles around the stoma and pressure on the abdomen where the faceplate contacts. They attempted to improve the discomfort and ease of use for ostomates. They discovered that adjusting the positional relationship between the inner diameter of the flat plate and the inner diameter of the skin barrier in the faceplate can prevent wrinkles around the stoma caused by body movements and reduce pressure on the abdomen where the faceplate contacts. Based on this finding, they completed the present invention. They have now provided a faceplate for a stoma appliance in which the inner diameter of the skin barrier is positioned within the inner diameter of the flat plate, and a stoma appliance including the faceplate. Furthermore, the flat faceplate of the present invention has the advantages of preventing wrinkles in the skin barrier and reducing pressure on the abdomen compared to convex faceplates.

[0017] In this specification, an appliance for temporarily storing excrement, excretory fluids, gas, exudates, secretions, waste products, etc. (hereinafter collectively referred to as "excrement"; the same applies below) from within or on the surface of a living body is referred to as an excrement storage appliance, and such excrement storage appliance may also be referred to as a stoma appliance.

[0018] This embodiment provides a base plate for a stoma appliance, which includes a flat plate having a first opening, a skin barrier having a second opening, and an opening (e.g., a stoma insertion hole) composed of at least the first opening and the second opening, with the second opening located within the first opening of the flat plate, and a stoma appliance comprising the same. The opening (e.g., the stoma insertion hole) provided in the base plate is preferably composed of at least the first opening and the second opening, which are arranged with approximately the same size as the first opening. The centers of the openings provided in the base plate are preferably positioned at approximately the same positions as the centers of the first opening and the second opening, and the centers of the first opening and the second opening are preferably positioned at approximately the same positions. The width of the flat plate is preferably greater than 15 mm.

[0019] Furthermore, a preferred aspect of this embodiment is a face plate for a stoma appliance, which comprises a flat plate having a first opening, a skin protective agent having a second opening, and an opening (e.g., a hole for inserting a stoma) composed of at least the first opening and the second opening, and the plate end toward the center of the flat plate is located within the same or nearby area outward from the second opening.

[0020] In another aspect of this embodiment, the flat plate is preferably a flat plate for use as a base plate for a stoma appliance. In a more preferred embodiment, a flat plate can be provided that has a first opening for forming an opening (e.g., a stoma insertion hole) in the base plate, and that the plate edge toward the center is positioned within the same or adjacent area as a second opening in the skin barrier on the base plate for forming the stoma insertion hole.

[0021] As another aspect of this embodiment, a base plate for a waste collection device, which includes a flat plate having a first opening, a skin protective agent having a second opening, and an opening (also called a hole) composed of at least the first opening and the second opening, with the second opening located within the first opening of the flat plate, and a waste collection device including the same can be provided. This can achieve another object of suppressing wrinkles that occur around the stoma due to body movement when wearing the waste collection device for waste discharged through a drain for drainage or a stoma for defecation, etc., and reducing the surface pressure generated at the attachment portion where the base plate comes into contact.

[0022] In this specification, the contents of each configuration, method, etc. described in any of sections such as "1.", "2.", "3.", etc. may be omitted as appropriate in the explanation of each section, and the explanation contents of each section (each configuration, each method, etc.) may be adopted as appropriate to apply to this embodiment of the present invention in other sections.

[0023] 2. Face plate according to this embodiment This embodiment can provide a base plate comprising a flat plate having a first opening and a skin protector having a second opening, the second opening being configured to be positioned within the first opening of the flat plate. The base plate preferably has a hole formed by at least a first opening and a second opening, and more preferably the hole is a hole for inserting a stoma. The base plate is preferably a base plate used for a stoma appliance, and more preferably a base plate for a stoma appliance that can be attached to the abdomen. The face plate is preferably configured so that its edge toward the center of the face plate is located within the same or adjacent area outward from the second opening in the skin barrier, which defines the first opening and the hole. This "within the same or adjacent area" preferably refers to a ratio of [diameter of the first opening in the face plate / diameter of the second opening in the skin barrier] between 1 and 1.4 times the diameter of the second opening in the skin barrier. The width of the face plate is preferably greater than 15 mm. Furthermore, the plate bending stress in the face plate is preferably 2N or more and 30N or less.

[0024] The base plate according to this embodiment may be a medical component, such as a medical component used for one or more of an ostomy appliance pouch, a drainage pouch, a fecal bag, a urine collection bag, a urine collection bag, etc. In the case of a base plate used as a medical component, it may be a base plate for a waste collection appliance.

[0025] The face plate of this embodiment will be described with reference to FIGS. 1 to 4, but this embodiment is not limited to these drawings and symbols.

[0026] 2-1.Flat plate FIG. 1 shows a back view (FIG. 1A) and a front view (FIG. 1B) of a flat plate 10, where FIG. 1A is a back view of the flat plate 10 seen from the side that contacts the pouch 30, and FIG. 1B is a front view of the flat plate 10 seen from the side that contacts the skin protective agent 20. The flat plate 10 preferably has a hollow, approximately circular shape with a substantially circular opening 15 in the center when viewed from either the front or back. When the flat plate 10 is viewed in an orthographic projection, the shape when viewed from the left-right direction (left side view, right side view) and / or the top-bottom direction (top view, bottom view) is not particularly limited. For example, as shown in Figures 1C and 4, the flat plate 10 is preferably a shape with a flat surface on both or either one of its surfaces (e.g., a rectangular shape (including a square shape)), more preferably a hollow rectangular shape with an opening 15 in the center. Note that the hollow rectangular surface may have a flat convex or concave portion for attachment to a pouch or skin protective agent.

[0027] 1A shows a flat plate 10 having a single, generally flat, convex periphery located midway between the center and the periphery, with a central opening 15. The flat plate 10 is preferably provided with a storage section 30 on its rear surface. This convex periphery may be omitted, or one or more may be provided. For example, it is preferable to have one or more flat convex peripheries for attachment (bonding, adhesion, etc.) to the storage section 30, etc.

[0028] 1B shows a flat plate 10 having a generally flat surface and a central opening 15. The flat plate 10 is preferably provided with a skin protectant 20 on its front portion, thereby forming a face plate 100.

[0029] The size of the flat plate 10 used in this embodiment is not particularly limited, but it is preferably a size that can be used as a face plate for a waste collection appliance, and more preferably a size that can be used as a face plate for a stoma appliance.

[0030] The flat plate 10 preferably has a first opening 15. The first opening 15 is preferably located approximately in the center of the flat plate 10, and / or the first opening 15 is preferably formed to be equal to or larger than the second opening 25 of the skin protective agent 20 that is joined to the flat plate 10. The size of the first opening 15 is preferably approximately the same as or larger than the size of the second opening 25 of the skin protective agent 20 constituting the base plate 100, and more preferably approximately the same size. When the size of the second opening is taken as 100%, the size of the first opening and the second opening being approximately the same may mean that there is a dimensional difference of 0.05%, 0.1%, 0.5%, 1%, 2%, or 3% or less, and the smaller this difference is the better, and they may even be the same size.

[0031] In this specification, the criteria for determining size are not particularly limited, but it is preferable to determine the size on a plane (X-axis and / or Y-axis), and in this case, it is desirable to determine the area or diameter. Furthermore, the diameter is not particularly limited, and examples thereof include the maximum major axis, maximum minor axis, diameter, radius, inner diameter, and outer diameter.

[0032] Furthermore, it is preferable that the center of the first opening 15 is disposed so as to be approximately coincident with the center of the flat plate 10. The center of the first opening 15 may be offset from the center (or center line) of the flat plate 10 by, for example, 0.05 mm, 0.1 mm, 0.5 mm, 1 mm, 2 mm, or 3 mm or less, and the smaller this offset is the better, and it may be coincident with the center of the flat plate. It is also preferable that the center of the first opening 15 is disposed so as to be approximately coincident with the center of the face plate 100, and this "approximately identical" is essentially the same as the above-mentioned "approximately identical," and in this case, it is preferable that the offset from the center of the face plate 100 is within the above-mentioned numerical range (for example, 0.1 mm or less), and it may be coincident with the center of the face plate 100.

[0033] In this specification, the "center" may be "on the center line" or "on the central axis," and the same center may be on the same center line (on the central axis).

[0034] In addition, when aligning the first opening 15 (preferably the inner diameter) of the flat plate 10 with the second opening 25 (preferably the inner diameter) of the skin protective agent 20, it is more preferable that the center of the first opening and the center of the second opening are in approximately the same position, and this may form an opening or hole in the face plate. This "approximately the same" is essentially the same as the above-mentioned "approximately the same." In this case, a deviation from either center within the above-mentioned numerical range (e.g., 0.1 mm or less) is preferred, and both centers may be in the same position.

[0035] The shape of the flat plate or the shape of the first opening is not particularly limited, but examples include a substantially elliptical shape, a substantially circular shape, and a polygonal shape (e.g., a polygonal shape with 3, 4, 5, 6, 8, etc. sides; a regular polygonal shape such as a rectangle, a parallelogram, or a square), and one or more types selected from these are preferred, with a substantially circular shape being preferred. The shape of the first opening is preferably matched to the cross-sectional shape of the outer periphery of the stoma (e.g., the insertion portion) or to the shape of the second opening, and it is preferable that the corresponding or opposing shapes are the same. In the case of a polygonal shape, the center may be the intersection of the diagonals.

[0036] The first opening in the flat plate is preferably used as a hole for the waste flow path, and more preferably, a hole into which the tip of a waste flow path such as a stoma is inserted is formed together with the second opening in the skin protective agent.

[0037] The outer diameter (preferably diameter) of the flat plate is not particularly limited, but a suitable lower limit is preferably 70 mm or more, more preferably 80 mm or more, and even more preferably 90 mm or more, and a suitable upper limit is preferably 140 mm or less, more preferably 130 mm or less, even more preferably 120 mm or less, and even more preferably 110 mm or less, with a suitable numerical range being 80 to 120 mm. The outer diameter of the flat plate may be the maximum major axis of the flat plate. The outer diameter of the flat plate may also be the diameter when viewed from the front or back.

[0038] The plate width of the flat plate is not particularly limited, but a suitable lower limit is preferably 10 mm or more, more preferably 15 mm or more, even more preferably more than 15 mm, more preferably 16 mm or more, more preferably 17 mm or more, more preferably 18 mm or more, more preferably 19 mm or more, and more preferably 20 mm or more, and a suitable upper limit is preferably 50 mm or less, more preferably 40 mm or less, 35 mm or less, or 30 mm or less. The plate width is a value calculated by dividing the outer diameter of the flat plate by the inner diameter of the flat plate by 2.

[0039] The inner diameter (preferably diameter) of the flat plate is not particularly limited, but a suitable lower limit is preferably 20 mm or more, more preferably 30 mm or more, 35 mm or more, or 40 mm or more, or 30 to 50 mm or more, and a suitable upper limit is preferably 90 mm or less, more preferably 80 mm or less or 70 mm or less, and even more preferably 75 mm or less or 60 mm or less, with a suitable numerical range being 35 to 60 mm. The inner diameter of the flat plate may be the diameter of the first opening. The diameter of the first opening may be the diameter when viewed from the front or back, and may be the maximum long diameter.

[0040] The thickness of the flat plate is not particularly limited, but a suitable lower limit is preferably 0.3 mm or more, more preferably 0.5 mm or more, and even more preferably 0.8 mm or more, and a suitable upper limit is preferably 2 mm or less, more preferably 1.5 mm or less, and even more preferably 1.3 mm or less, with a suitable numerical range of 0.8 to 1.3 mm. The thickness of the flat plate is the thickness when viewed from the right side or left side.

[0041] The material of the flat plate is not particularly limited. From the viewpoint of suppressing wrinkles on the skin, a flexible resin is preferred, and a thermoplastic resin is more preferred. The thermoplastic resin is preferably selected from resins generally used for flat plates of stoma appliances, such as polyolefin resins, of which polyethylene (PE) resin, polypropylene (PP) resin, and ethylene-vinyl acetate copolymer (EVA) resin are preferred. In this embodiment, the material of at least the portion that is bonded to and supports the skin protective agent is preferably selected from the above-mentioned resins. One or more of these may be selected. In this specification, the desired material for the flat plate is preferably prepared by blending multiple materials to achieve a plate bending stress of 2N to 30N, and more preferably within a suitable numerical range of plate bending stress.

[0042] 2-2. Skin barrier 2 to 4 show a skin protective agent 20, which preferably has a second opening 25. The skin protective agent 20 is preferably used to fix or support a stoma appliance to the skin around an excretion hole (e.g., a stoma) for storing fluids such as feces, urine, or body fluids excreted from the excretion hole, such as an artificial anus, an artificial bladder, or various fistula products. The skin protective agent 20 preferably has one surface for bonding to the surface of the flat plate 10, and the other surface for bonding to the skin around the excretion hole.

[0043] When viewed from either the front or back of the skin protective agent 20, it is preferable that the skin protective agent 20 has a hollow, approximately circular shape with a substantially circular opening 25 in the center. When the skin protective agent 20 is viewed using an orthographic projection, the shape when viewed from the left-right direction (left side view, right side view) and / or the top-bottom direction (top view, bottom view) is not particularly limited, but for example, as shown in Figure 4, a shape with flat surfaces on both or either side (such as a rectangular shape (including a square shape)) is preferred, and a hollow rectangular shape (including a square shape) with an opening 25 in the center is more preferred.

[0044] The size of the skin protective agent 20 used in this embodiment is not particularly limited, but it is preferably a size that can be used as a face plate for a waste collection appliance, and more preferably a size that can be used as a face plate for a stoma appliance.

[0045] The skin protective agent 20 preferably has a second opening 25. The second opening 25 is preferably located approximately in the center of the skin protective agent 20, and / or the second opening 25 is preferably formed to be equal to or smaller in size than the first opening 15 of the flat plate 10 that is joined to the skin protective agent 20.

[0046] The size of the second opening 25 is preferably approximately the same as or smaller than the size of the first opening 15 of the flat plate 10 constituting the face plate 100, and more preferably approximately the same size. When the size of the first opening is taken as 100%, the second opening and the first opening being approximately the same size may have a dimensional deviation of 0.05%, 0.1%, 0.5%, 1%, 2%, or 3% or less, and the smaller this deviation is the better, and they may be the same size.

[0047] Furthermore, the center of the second opening 25 is preferably positioned so that it is substantially coincident with the center of the skin protective agent 20. The center of the second opening 25, which is positioned so that it is substantially coincident with the center of the skin protective agent 20, may be offset from the center (or center line) of the skin protective agent 20 by, for example, 0.05 mm, 0.1 mm, 0.5 mm, 1 mm, 2 mm, or 3 mm or less; the smaller this offset, the better; and the second opening 25 may be aligned with the center of the skin protective agent 20. Furthermore, the center of the second opening 25 is preferably positioned so that it is substantially coincident with the center of the base plate 100; "substantially identical" is essentially synonymous with "substantially identical" as described above; in this case, the offset from the center of the base plate 100 within the above-described numerical range (e.g., 0.1 mm or less) is preferable, and the second opening 25 may be aligned with the center of the base plate 100.

[0048] The shape of the skin protective agent or the shape of the second opening is not particularly limited, but can be any of the shapes described above for the "flat plate shape or first opening shape," and examples include a generally elliptical shape, a generally circular shape, a polygonal shape, etc. One or more shapes selected from these are preferred, with a generally circular shape being preferred. The shape of the second opening is preferably matched to the cross-sectional shape of the periphery of the stoma (e.g., the insertion portion) or to the shape of the first opening, and it is preferable that these shapes are the same. The second opening is preferably used as a hole for the waste flow path, and more preferably, a hole into which the tip of a waste flow path such as a stoma can be inserted can be formed together with the first opening of the flat plate.

[0049] The shape and holes of the skin protective agent or the second opening, and the relationship with the flat plate and the first opening can be appropriately determined from the configuration described above in "2-1. Flat Plate." For example, the shape of the second opening is preferably approximately circular, and if it is polygonal, the center may be the intersection of the diagonals.

[0050] The outer diameter (preferably the diameter) of the skin protective agent is not particularly limited, but is preferably large enough to cover the size of the flat plate, and is preferably equal to or larger than the size or outer diameter of the flat plate. The outer diameter of the flat plate is preferably 80 to 130 mm, more preferably 90 to 120 mm. The outer diameter of the skin protective agent may also be the maximum major axis of the skin protective agent. The outer diameter of the skin protective agent may also be the diameter when viewed from the front or back. The thickness of the skin protective agent is not particularly limited, but may be, for example, approximately 0.1 to 2 mm, such as the thickness of commercially available skin protective agents for stoma appliances. The thickness of the skin protective agent is measured when viewed from the right or left side.

[0051] The inner diameter of the skin protective agent is not particularly limited, but may or may not contact the stoma opening. The inner diameter (preferably diameter) of the skin protective agent preferably has a lower limit of 5 mm or more, more preferably 10 mm or more, or 20 mm or more, or 25 mm or more, or 30 mm or more, and a preferred upper limit of 60 mm or less, more preferably 50 mm or less, or 45 mm or less, or 40 mm or less, with a preferred numerical range of 10 to 50 mm. The inner diameter of the skin protective agent may be the diameter of the second opening. The diameter of the second opening may be the diameter when viewed from the front or back, and may be the maximum major axis.

[0052] The skin protective agent preferably has a skin protective effect (the effect of maintaining the physiological state of the skin) and preferably has adhesive properties in the area that comes into contact with the skin. The substrate for the skin protective agent is not particularly limited, but examples include nonwoven fabrics, woven fabrics, films, and foam sheets. The composition constituting the skin protective agent is not particularly limited, and conventional compositions or commercially available products can be used.

[0053] 2-3. Face plate The base plate 100 used in this embodiment preferably comprises a flat plate 10 having a first opening 15 and a skin protective agent 20 having a second opening 25. The base plate 100 preferably has an opening, more preferably an opening consisting of at least the first opening 15 and the second opening 25, even more preferably a hole for an excrement flow path into which the tip of an excrement flow path (e.g., a stoma, drain tube, catheter tube, etc.) constructed in or on the surface of the living body is inserted, and even more preferably a hole for inserting a stoma. The opening may also be a hole.

[0054] It is preferable that the center of the opening in the face plate 100 is positioned approximately identical to the center of the first opening 15 or the center of the second opening 25, or the center of both, and it is more preferable that it is positioned approximately identical to the centers of the first opening and the second opening. Furthermore, the shape of the first opening 15 and the shape of the second opening 25 are preferably substantially the same or the same shape. The shape of the flat plate 10 and the shape of the skin protective agent 20 are preferably substantially the same or the same shape.

[0055] The opening, which is at least composed of the first opening 15 and the second opening 25, is typically a free-cut type that can be freely adjusted by cutting or the like to fit the size (outer diameter) of the tip portion to be inserted (e.g., a stoma), a pre-cut type that is pre-adjusted to a fixed size by cutting or the like, or a moldable type that allows the size of the hole (e.g., a hole for stoma insertion) to be adjusted with a finger. In this embodiment, one or more types selected from these can be used, but pre-cut types are preferred from the viewpoint of aligning the first opening and the second opening. In addition, in this embodiment, in the case of a free-cut type, it is preferable that the openings can be positioned within a desired range of the same or nearby areas when adjusted by cutting or the like. In the case of a moldable type, it is preferable that the opening size can be adjusted to be positioned within a desired range of the same or nearby areas when adjusted.

[0056] Furthermore, the face plate 100 is preferably configured so that the second opening 25 (preferably the outer periphery of the second opening) is located within the first opening 15 (preferably the outer periphery of the first opening) of the flat plate 10. Furthermore, the face plate 100 is preferably configured so that the plate end toward the center of the flat plate 10 is located within the range of the same or nearby area located outward from the second opening 25. Furthermore, the range of the same or nearby area can be set by the ratio of the inner diameter of the first opening / the inner diameter of the second opening described above. For each inner diameter, for example, the first opening 15 (inner diameter 16) and the second opening 25 (inner diameter 26) as shown in FIG. 2 can be referred to, and the lengths of these inner diameters in FIG. 2 are lengths passing through their respective centers (or intersections in the case of polygonal shapes). The outer diameter of the flat plate 10 may be the sum of the left plate width 18, the flat plate inner diameter 16, and the right plate width 18, and it is preferable that these are on the same straight line. Furthermore, the right plate width 18 and the left plate width 18 may be different lengths, but it is preferable that they are the same length.

[0057] The above-mentioned "within the same or similar range" preferably means that the inner diameter of the first opening and the inner diameter of the second opening are similar to or the same, and the preferable lower limit of the ratio of [diameter of first opening / diameter of second opening] is preferably 1 or more, and the preferable upper limit is preferably 2 or less, more preferably 1.4 or less, even more preferably 1.3 or less, more preferably 1.2 or less, more preferably 1.1 or less, more preferably 1.05 or less, more preferably 1.01 or less, even more preferably 1.005 or less, and more preferably 1.001 or less. Note that the inner diameter of the first opening may be similar to or the same as the inner diameter of the second opening, and the inner diameter of the second opening may be similar to or the same as the inner diameter of the first opening.

[0058] In this embodiment, it is preferable for the face plate to have appropriate conformability, from the viewpoint of better suppressing wrinkle formation in the skin protective agent and reducing surface pressure on the abdominal area. In a more preferred embodiment, the plate bending stress of the face plate has a preferred lower limit of 0.1 N or more, more preferably 0.5 N or more, and even more preferably 2 N or 3 N or more, and a preferred upper limit of 40 N or less, more preferably 30 N or less, even more preferably 20 N or less, more preferably 10 N or less, and even more preferably 8 N or less, with a preferred numerical range of 2 to 30 N, and even more preferably 3 to 10 N. The plate bending stress can be measured according to the <Plate bending stress test> described in the Examples section below.

[0059] Preferably, face plate 100 is formed from at least flat plate 10 and skin protective agent 20, which are bonded directly or indirectly. This bonding can be achieved by any known bonding method used for face plates, including, but not limited to, adhesive bonding or thermal welding. For example, flat plate 10 and skin protective agent 20 may be fixed together using an adhesive or thermal welding material. In this case, a backing film 21 may be placed on the flat plate side of skin protective agent 20 to facilitate bonding to flat plate 10. Examples of the backing film include a plastic film.

[0060] The base plate used in this embodiment may be either adhesive or non-adhesive, but an adhesive base plate is preferred. In the case of an adhesive base plate, the base plate may be brought into contact with the skin using an adhesive skin protectant, but this is not limiting.

[0061] 3. Stoma appliance according to this embodiment The stoma appliance according to this embodiment can provide a stoma appliance comprising the above-described stoma appliance base plate and a storage section that is joined to the base plate and stores waste from the stoma. The storage section is not particularly limited as long as it can store waste from the stoma, and examples thereof include a pouch. The material constituting the storage section such as a pouch can be the same as that used in the past. Furthermore, in this embodiment, it is preferable that the flat plate in the base plate for the stoma appliance has a second opening located within the first opening of the flat plate, and that the first opening is located within a third opening of the storage section that stores waste from the stoma. Note that it is preferable that the center of the third opening is positioned approximately in the same position as the center of the opening provided in the base plate. Furthermore, in this embodiment, it is preferable that the diameter of the first opening of the flat plate in the faceplate for the above-mentioned stoma appliance is equal to or larger than the diameter of the second opening, and equal to or smaller than the diameter of the third opening of the storage section that stores waste from the stoma.

[0062] The stoma appliance used in this embodiment may be either a one-piece type or a two-piece type, but a one-piece type is preferred.

[0063] A one-piece type is an appliance in which the base plate and the storage section are integrally formed by thermal fusion or the like. In this embodiment, a one-piece appliance including the base plate of this embodiment described above, and a base plate of this embodiment for a one-piece appliance can be provided. An example of such a one-piece appliance is a one-piece excrement storage appliance as shown in FIG. 1.

[0064] A two-piece system is an appliance in which a first joint provided on the base plate and a second joint provided on the housing section are detachably joined. The two-piece system may be a combination product consisting of at least a base plate portion and a housing section portion, and the combination product may be a set product or a kit product.

[0065] In this embodiment, a two-piece orthosis including the above-described base plate of this embodiment, and a base plate of this embodiment for a two-piece orthosis can be provided. As an example of a suitable aspect of a two-piece system, a base plate for a two-piece orthosis having a first joint portion that can be joined to a second joint portion of the housing portion can be provided. For example, the first and second joint portions are preferably circular ring-shaped, and are preferably configured so that they can be detachably fitted together by adhesive or the like. For example, the inner diameter of the first joint portion may be approximately the same as or larger than the inner diameters of the first and second openings of the flat plate and the inner diameter of the hole formed by them, but is preferably larger than these. The inner diameter of the second joint portion may be approximately the same as or different from the inner diameter of the hole of the housing portion, but is preferably approximately the same.

[0066] In this embodiment, the stoma appliance may be a waste material storage appliance, the stoma may be a waste material flow path constructed inside or on the surface of the body, the stoma insertion hole may be a hole for the waste material flow path, and the storage section for storing waste material may be a pouch. Examples of excrement collection appliances include ostomy appliances, drainage pouches, fecal bags, urine collection bags, and urine collection bags, and one or more of these may be selected.

[0067] 3 and 4 show one embodiment of the stoma appliance 200 of the present embodiment, but the present embodiment is not limited to this. Fig. 3 is a front view showing an example of the configuration of the stoma appliance, and is a view of the side on which a face plate is provided on the surface of the housing section 30, which is the side that comes into contact with the abdomen around the stoma. When the stoma appliance 200 is viewed from the back, there is no face plate on the surface of the housing section 30, and no holes are provided (not shown).

[0068] 3, the stoma appliance 200 of this embodiment preferably includes a storage section 30 that stores excrement, and an outlet 40 that discharges the stored excrement from the storage section 30 to the outside. The outlet 40 preferably includes an outlet path 41 that connects the storage section 30 and an attachment 42, and the attachment 42 that discharges the excrement from the outlet path 41 to the outside.

[0069] FIG. 4 is a cross-sectional view of the XX′ portion of FIG. 3 when the skin protective agent 20 of the base plate 100 of the stoma appliance 200 is brought into contact with skin (not shown) where a stoma is present. The right side is the skin side, and the left side is the storage compartment 30 side. The stoma insertion hole of the stoma appliance 200 is composed of at least a first opening 15 and a second opening 25 of the base plate 100, and the storage compartment 30 has a third opening 35. The diameter of the second opening 25 of the skin protective agent 20 is preferably large enough to allow a portion or all of the stoma 50 to be inserted into the stoma insertion hole and allow waste from the stoma 50 to flow into the storage compartment 30. More preferably, the diameter is approximately the same as or larger than the outer diameter of the stoma 50. It is even more preferable that the second opening 25 is configured to be in contact or nearly in contact with the outer diameter of the stoma 50. The term “nearly in contact” means, for example, more than 0 mm and less than 5 mm, preferably more than 0 mm and less than 2 mm.

[0070] A stoma appliance 200 according to one embodiment of the present invention comprises a base plate 100 and a storage section 30 for storing waste from the stoma, and the base plate 100 is preferably provided on the upper part of one surface of the stoma appliance 200. An adhesive layer is preferably provided on the skin protectant 20 of the base plate 100, and this adhesive layer allows the stoma appliance 200 to be attached to the patient's stoma and the surrounding skin.

[0071] The storage section 30 is preferably in the form of a bag sealed using a plastic film. A face plate 100 is provided on the top of the excrement storage device 200. The storage section 30 may be either an open-close type or a closed type. It may be either an open-close type with an outlet through which excrement is discharged, or a closed type without an outlet. The open-close type is preferred because excrement stored in the storage section can be appropriately discharged to the outside through the outlet.

[0072] The fitting 42 of the outlet 40 is provided with a discharge opening and a cap that closes the opening, and by closing the discharge opening with the cap, the waste is contained in the stoma appliance 200. The fitting 42 is attached to the outlet 40 by thermal fusion or the like. By removing the cap from the discharge opening, the discharge opening is opened and the waste can be discharged to the outside.

[0073] The discharge opening is not particularly limited, and any discharge opening used in a stoma appliance can be appropriately adopted, such as a foldable type (also called a roll-up type) in which the discharge opening is opened and closed by folding a hook-and-loop fastener or the like, a clip type in which the discharge opening is opened and closed with a clip or the like, a cap type in which the discharge opening is opened and closed by inserting or pulling out a cap, and a cock type in which the discharge opening is opened and closed with a cock opening / closing valve.

[0074] The storage section 30 is attached to the stoma 50 of a user such as a patient and its surroundings by the adhesive layer of the skin protective agent 20 of the base plate 100 provided in the stoma appliance 200. The waste material passes through a stoma insertion hole constituted by at least the first opening 15 and the second opening 25 of the base plate 100 and is discharged into the storage section 30. The waste material contained in the pouch 30 passes through the discharge path 41 and is discharged from the discharge opening of the mouthpiece 42.

[0075] In this embodiment, it is possible to provide a face plate and a stoma appliance that uses the face plate, which can suppress wrinkles that occur around the stoma due to body movements when wearing the stoma appliance and can reduce the surface pressure that occurs on the abdomen where the face plate comes into contact when living with the stoma appliance.

[0076] 3 and 4 is not limited to a stoma appliance, but can also be described as a waste collection appliance, in which case, for example, the stoma appliance 200 may be the waste collection appliance 200, the stoma insertion hole may be an opening, and the stoma may be a drain (tube-type or the like) used for drainage. This makes it possible to provide a base plate and a waste collection appliance using the base plate that can suppress wrinkles that occur around the stoma due to body movements when wearing the waste collection appliance and reduce the surface pressure that occurs at the contact points of the base plate when living.

[0077] The present invention can also have the following configuration. [1] A flat plate having a first opening; a skin barrier having a second opening; a stoma insertion hole constituted by at least the first opening and the second opening, the second opening being located within the first opening of the flat plate. The stoma appliance may be a waste collection appliance. [2] A flat plate having a first opening; a skin barrier having a second opening; and a stoma insertion hole composed of at least the first opening and the second opening, and the plate end in the center direction of the flat plate is located within the same or adjacent area outward from the second opening. A face plate for a stoma appliance or a face plate for a stoma appliance according to the above [1]. [3] The base plate for an stoma appliance according to [2], wherein the range of the same or adjacent region is within a range of 1 to 1.4 times the diameter of the second opening. [4] The base plate for an ostomy appliance according to any one of [1] to [3], wherein the plate width of the flat plate is greater than 15 mm. [5] The base plate for an ostomy appliance according to any one of [1] to [4], wherein the material of the flat plate is a thermoplastic resin. [6] The base plate for an ostomy appliance according to any one of [1] to [5], wherein the plate bending stress in the base plate is 2 N or more and 30 N or less. [7] A stoma appliance comprising the base plate for a stoma appliance according to any one of [1] to [6] above. The stoma appliance may be a waste collection appliance. [8] The stoma appliance according to [7], further comprising a storage section that is joined to the base plate and that stores waste from the stoma. [9] The stoma appliance according to [7] or [8], wherein the diameter of the first opening of the flat plate is equal to or larger than the diameter of the second opening, and equal to or smaller than the diameter of a third opening of a storage section that stores waste from the stoma.

[10] The stoma appliance according to any one of [7] to [9] above, which is a one-piece stoma appliance.

[11] The face plate for a stoma appliance according to any one of [1] to [6] above or the stoma appliance according to any one of [7] to [9] above, wherein the face plate is for a one-piece appliance. [Example]

[0078] The effects of the present invention will be specifically described below with reference to examples, etc. However, the scope of the present invention is not limited to the examples described in this specification.

[0079] <Production Example 1> Each flat plate used in the present Examples was manufactured by molding a mold corresponding to Figures 1 and 2 based on the information on each flat plate of Examples 1 to 7 and Comparative Example 1 shown in Tables 1 and 2, and injection molding using a thermoplastic resin. The thermoplastic resin used in Examples 1 to 3 and Comparative Example 1 was low-density polyethylene. The thermoplastic resin used in Example 6 can be low-density polyethylene, and the thermoplastic resin used in Example 7 can be high-density polyethylene or polypropylene. The thermoplastic resins used in Examples 1 to 7 and Comparative Example 1 are commercially available products. The plate width (mm) in the tables is a value calculated by dividing the outer diameter of the flat plate by the inner diameter of the flat plate by 2.

[0080] For Comparative Example 2 in Table 1 below, a commercially available convex plate was obtained, and the difference between the height of the outer periphery and the height of the inner diameter was 4 mm. For the plates of Comparative Examples 1 and 3 and Examples 1 to 7, the plate on which the skin protective agent is to be applied was placed in contact with the tabletop, and when the outer periphery of the plate was pressed with a finger in a few places, almost no shaking was felt, so they were designated flat plates.

[0081] The skin protective agent used in this Example is the commercially available CellCare (R) One plate was obtained and cut to the desired size. Each panel used in this Example was obtained by using the flat plate and skin protective agent described above, adjusting the center of the inner diameter of the skin protective agent and the center of the inner diameter of the plate to be in the same position (on the same central axis), and then joining them as shown in Figure 2.

[0082] <Compression test (wrinkle prevention evaluation)> (1) A gel measuring 200 mm x 200 mm x 10 mm was prepared using a human skin gel concentrate (manufactured by Exseal Co., Ltd.) with a hardness of 0. This gel was placed on a table for the following compression. (2) Self-care (R) A hole of a size corresponding to the inner diameter of the plate listed in the table was drilled in the skin barrier No. 1. (3) The plate was attached to the skin barrier using double-sided tape (NITTO No. 5000NS), with the center of the inner diameter of the plate and the center of the inner diameter of the skin barrier aligned (on the same central axis). (4) The product prepared in (3) was attached to the center of the top surface of the gel prepared in (1) in both the vertical and horizontal directions. A ruler was placed on the desk so that the distance between the left and right ends of the compressed gel could be measured when the sides of the gel were compressed from both sides. (5) The panelists lightly touched the left and right ends of the lateral sides of the gel to which the (3) preparation had been attached (around the diameter of the plate) with the palms of their hands, and then compressed the plate until the outer diameter (the shortest distance between the left and right ends of the curved plate (the distance between the left and right ends of the gel after compression)) was 6 cm. (6) Panelists maintained the above compression and evaluated the total number of wrinkles in the skin barrier that connected to the inner diameter of the skin barrier as follows: Wrinkles in the gel that connected to the inner diameter of the skin barrier could cause leakage. Evaluation criteria: Rating point 5: 0 wrinkles, rating point 4: 1-3 wrinkles, rating point 3: 4-6 wrinkles, rating point 2: 7-9 wrinkles, rating point 1: 10 or more wrinkles. The evaluation scores in Tables 1 and 2 are the average scores when the number of panelists in this test was three, with each panelist taking one test.

[0083] <Surface pressure test (evaluation of discomfort)> (1) Self-care (R) The skin barrier agent No. 1 was attached to the plate using double-sided tape (NITTO No. 5000NS). (2) The product prepared in (1) was attached next to the navel of the panelist. (3) The panelists performed a sensory evaluation of the rebound sensation of the abdominal wall when bending forward at 45 degrees, according to the following evaluation criteria. Evaluation criteria: Rating point 5: No repulsion, Rating point 4: Repulsion weaker than standard 3, Rating point 3 (standard 3): Self care (R) 2. The same rebound as F, rating 2: The rebound is stronger than standard 3, rating 1: Cannot bend. The evaluation scores in Table 2 are based on the number of panelists in this test: 3, with each panelist taking 1 test, and are the average evaluation scores when these are added together.

[0084] <Plate bending stress test> (1) The test was carried out using a universal testing machine (Shimadzu Corporation; AGS-X). (2) The upper and lower ends (diametrically) of the outer edge of the vertically standing plate were gripped with the upper and lower chucks of the universal testing machine, and the plate was compressed 35 mm in the diametric direction at 1 mm / sec from the gripped upper and lower ends. (3) The maximum repulsive force (N) during the measurement was measured as the bending stress. The evaluation scores in Tables 1 and 2 are the average of three tests.

[0085] <Test Example 1>

[0086] [Table 1]

[0087] [Table 2]

[0088] <Consideration> As shown in Table 1, it was confirmed that wrinkles can be suppressed and discomfort caused by surface pressure can be reduced by using a face plate in which the center of the flat plate and the center of the skin protective agent are on the same central axis and the opening (inner diameter) of the skin protective agent is positioned within the opening (inner diameter) of the flat plate. It was considered that using a flat plate as in Examples 1 to 3 as a face plate is more desirable from the perspective of wrinkle suppression and discomfort caused by surface pressure than using a convex plate as in Comparative Example 2. More specifically, it is preferable that the plate edge toward the center of the flat plate be located within the same or adjacent area outward from the opening of the skin protective agent. In Comparative Example 3, the plate width is narrow and there are joints, making it thick, leading to poor flexibility and discomfort. It was considered that the face plates used in one-piece orthoses such as those in Examples 1 to 3 are more preferable from the perspectives of preventing wrinkles and reducing discomfort due to surface pressure. Since this favorable range of the same or adjacent region is 50 mm / 37 mm = 1.35 in Example 1, 37 / 32 = 1.16 in Example 2, and 37 / 37 in Example 3, it is more preferable that the range be 1 to 1.4 times the opening (inner diameter) of the skin protective agent. The width of the flat plate is preferably greater than 15 mm, more preferably 20 mm or more, and even more preferably 25 mm or more. Taking into account commercially available stoma appliances, it was considered preferable that the inner diameter of the flat plate be approximately 20 to 60 mm.

[0089] From the viewpoint of suppressing wrinkles and reducing discomfort from the surface pressure, it was confirmed that the surface pressure of the face plate used for the flat plate is preferably 2N to 30N, and from the viewpoint of even better reduction in discomfort from the surface pressure, it was considered that the pressure should be more preferably 2N to 10N, and even more preferably about 2N to 8N. A more preferable range for both suppressing wrinkles and reducing discomfort from the surface pressure was considered to be 3N to 8N.

[0090] In this specification, for convenience, explanations may be made using numbers or letters such as "first, second, third...", "A, B, C...", "primary, secondary, tertiary...", etc., but this does not limit the interpretation of the present invention in a narrow sense, and the order may be changed as desired. A combination product may be a combination item or a combination, or may be a set product, a set, or a kit product or a kit. [Explanation of symbols]

[0091] 10 flat plate; 15 first opening; 16 inner diameter of flat plate; 17 outer diameter (maximum long diameter) of flat plate; 18 plate width 20 skin barrier; 21 back film; 25 second opening; 26 inner diameter of skin barrier; 30 storage section (pouch); 35 third opening; 40 outlet; 41 mouthpiece; 42 outlet path; 50 stoma; 55 outer diameter of stoma 100 face plate 200 Stoma appliances

Claims

1. a planar plate having a first opening; a skin protectant having a second opening; a stoma insertion hole composed of at least the first opening and the second opening; Equipped with The second opening is located within the first opening of the planar plate. A faceplate for stoma appliances.

2. a planar plate having a first opening; a skin protectant having a second opening; a stoma insertion hole composed of at least the first opening and the second opening; Equipped with the plate end toward the center of the flat plate is located within the same or adjacent area outward from the second opening; A faceplate for stoma appliances.

3. The base plate for an ostomy appliance according to claim 2, wherein the range of the same or adjacent region is within a range of 1 to 1.4 times the diameter of the second opening.

4. The base plate for an ostomy appliance according to claim 2 , wherein the plate width of the flat plate is greater than 15 mm.

5. The base plate for an ostomy appliance according to claim 1 or 2, wherein the flat plate is made of a thermoplastic resin.

6. The base plate for an ostomy appliance according to claim 1 or 2, wherein a plate bending stress in the base plate is 2 N or more and 30 N or less.

7. A base plate for the stoma appliance according to claim 1 or 2; a storage section that is connected to the base plate and that stores waste from the stoma; A stoma appliance comprising:

8. 8. The stoma appliance according to claim 7, wherein the diameter of the first opening of the flat plate is equal to or larger than the diameter of the second opening, and equal to or smaller than the diameter of a third opening of a storage section that stores waste from the stoma.

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