A release layer / backing laver for an ostomy body fitment

Abstract

A release layer for an ostomy body fitment. The ostomy body fitment may comprise an adhesive pad for forming a seal between an ostomy appliance and a stoma of an ostomate through one or more operational steps. The release layer has a formation for receiving part of a digit of a person's hand and is positioned such that, when an adhesive pad of an ostomy body fitment is supported by the release layer, the formation is proximate an edge of the adhesive pad and provides a tactile indication to a user as to the correct implementation of one or more operational steps in the utilization of the ostomy body fitment. The formation may be a depression or hole formed in a surface of the release layer.

Description

[0001] A Release Layer / Backing Laver for an Ostomy Body Fitment

[0002] Technical Field of the Invention

[0003] The present invention provides a release layer, also known as a backing layer for an ostomy body fitment.

[0004] Background to the Invention

[0005] Individuals that cannot pass waste naturally due to illness, injury or disease may require a colostomy, ileostomy, or urostomy. A colostomy or ileostomy involves attaching a section of the colon or small intestine respectively to an opening in the abdominal wall. A urostomy involves attaching a section of the urinary system to the abdominal wall in cases where drainage of urine through the bladder and urethra is not possible. In each case, a stoma for the excretion of waste from the body is formed at the opening that protrudes from the abdominal wall.

[0006] An ostomy appliance generally comprises a skin barrier or ostomy body fitment with a stomal aperture and a pouch for the collection of excreted waste. The ostomy body fitment of the ostomy appliance may be affixed by adhesive to the body of an individual around the stoma for the collection of excreted waste from the stoma into the pouch. An ostomy appliance may be provided as a single piece comprising both the ostomy body fitment and the pouch in a single pouch system. Alternatively, the ostomy appliance may be provided as a multi-piece (e.g., two piece) pouch system in which the ostomy body fitment and the ostomy pouch are separate components and may be attached together. For a multi-piece system, the ostomy body fitment may be first attached to the body of the ostomate around the stoma and the pouch may be attached to the ostomy body fitment to form the ostomy appliance for the collection of waste. Regardless of the system, it is important that an effective seal is formed between the stoma and the ostomy appliance to prevent leakage of excreted waste material.

[0007] Since ostomy appliances are often fitted by the patkient themselves, it is also important to provide a means for users to attach the ostomy appliance to their body easily, securely, and reliably, and without discomfort. Furthermore, since ostomy appliances are unsightly, it is important to try and ensure such devices are as discrete as possible. Reference is made to EP1378219 which describes an ostomy appliance incorporating a shapeable adhesive which can be manipulated to form a custom shaped fit around a wearer's stoma.

[0008] Reference is also made to Figures 1 to 3 which depict existing skin barriers or ostomy body fitments 1 for use in providing a seal between the user and an ostomy appliance comprising a tri-laminate structure 3 with a centrally located stomal aperture 5. The tri-laminate structure comprises a first, skin-facing, depicted lower, layer 7 comprising an adhesive for attaching the device to the skin of a patkient, a second, elastic mid-layer 9 with a degree of memory for rebounding and hugging the stoma, and a third, pouch facing, depicted upper layer 11 comprising an adhesive hydrocolloid material operable to swell and hug the stoma, when in use. A removable release layer or liner (not shown) may be attached to the skin-facing layer 7 and also to the pouchfacing layer 11 to protect the respective layers until installation of the device by a user.

[0009] The ostomy body fitment 1 is intended to be installed according to a procedure comprising multiple, sequential operational steps. The operational steps include removing the release layer from the pouch-facing layer 11 and as shown in Figure 2, rolling the tri-laminate structure 3 from the inner edge 13 of the stomal aperture 5 outwardly and upwardly to form a raised collar or “turtleneck” 15. As shown in Figure 3 the device is affixed to the skin of the patkient such that the stoma 17 extends through the stomal aperture 5 of the body fitment 1 and the rolled collar 15 extends upwardly from the pouch-facing layer 11 and hugs the external wall of the stoma 17 with a snug fit. An ostomy pouch (not shown) may then be adhered to the ostomy body fitment 1, via the adhesive surface of the pouch-facing layer 11 such that a secure and reliable seal is formed between the stoma 17 and the resulting ostomy appliance.

[0010] One problem with existing ostomy body fitments as described above is that the multi-step application procedure is difficult for users to follow, even with accompanying instructions. Consequently, users frequently remove the wrong release layer at the wrong time and / or roll the device in the wrong direction. This can result in the device being incorrectly applied such that the collar extends inwardly toward the user and / or such that the wrong adhesive side is affixed to the skin of the user. The incorrect application of the ostomy body fitment may compromise the effectiveness of the seal between the ostomate and an ostomy appliance, and thereby give rise to undesirable leakage from the stoma, as well as discomfort.

[0011] The present invention seeks to provide a release layer I backing layer for an ostomy body fitment that encourages the correct utilization of the ostomy body fitment. Summary of the Invention

[0012] The present invention provides a release layer, also referred to herein as a backing layer, according to the appended claims.

[0013] The present disclosure provides a release layer I backing layer for an ostomy body fitment. The ostomy body fitment may comprise an adhesive pad for forming a seal between an ostomy appliance and a stoma of an ostomate through one or more operational steps. The release / backing layer may comprise a formation in a surface thereof for receiving part of a digit of a person’s hand. The formation may be positioned such that, when the adhesive pad is supported by the release / backing layer, the formation is proximate an edge of the adhesive pad. The formation may provide a tactile indication to a user as to the correct implementation of one or more operational steps in the utilization of the ostomy body fitment.

[0014] Accordingly, a first aspect of the invention provides a release layer for an ostomy body fitment, the ostomy body fitment comprising an adhesive pad for forming a seal between an ostomy appliance and a stoma of an ostomate through one or more operational steps, the release layer comprising a formation for receiving part of a digit of a person’s hand and wherein the formation is positioned such that, when the adhesive pad is supported by the release layer, the formation is proximate an edge of the adhesive pad and provides a tactile indication to a user as to the correct implementation of one or more operational steps in the utilization of the ostomy body fitment.

[0015] Advantageously, the formation indicates to a user of the ostomy body fitment the correct direction in which to roll the adhesive pad during an installation procedure. The formation also allows a part of the adhesive pad to be more easily engaged by a user when attempting to remove the adhesive pad from the release / backing layer. For example, the formation may provide a recess that lies below the interfacing surfaces of the adhesive pad and release / backing layer so that an edge of the adhesive pad can be more easily “caught” by a digit of a user’ s hand, thereby facilitating removal of the adhesive pad from the release / backing layer.

[0016] Accordingly, in one preferred embodiment, there is provided a release layer for an ostomy body fitment, the ostomy body fitment comprising an adhesive pad for forming a seal between an ostomy appliance and a stoma of an ostomate through one or more operational steps, the release layer comprising a formation for receiving part of a digit of a person’s hand; wherein the formation is positioned such that, when the adhesive pad is supported by the release layer, the formation is proximate an edge of the adhesive pad and provides a tactile indication to a user as to the correct implementation of one or more operational steps in the utilization of the ostomy body fitment; and wherein the formation provides a recess that lies below the interfacing surfaces of the adhesive pad and release / backing layer (so that an edge of the adhesive pad can be more easily “caught” by a digit of a user’s hand, thereby facilitating removal of the adhesive pad from the release / backing layer).

[0017] The formation may be positioned to sit within the boundary of a stomal aperture of the adhesive pad when the adhesive pad is supported by the release / backing layer. The formation may be positioned proximate an edge of a stomal aperture of the adhesive pad when the adhesive pad is supported by the release / backing layer.

[0018] Accordingly in one preferred embodiment there is provided a release layer for an ostomy body fitment, the ostomy body fitment for forming a seal between an ostomy appliance and a stoma of an ostomate through one or more operational steps, the release layer comprising a formation formed in a surface thereof for receiving part of a digit of a person’s hand and wherein the formation is positioned such that, when an ostomy body fitment is supported by the release layer, the formation is proximate an edge of the ostomy body fitment and provides a tactile indication to a user as to the correct implementation of one or more operational steps in the utilization of the ostomy body fitment; wherein the formation comprises a depression formed in a surface of the release layer or a hole extending through the release layer; and wherein the formation is positioned proximate an edge of a stomal aperture of the ostomy body fitment when the ostomy body fitment is supported by the release layer. The release / backing layer may further comprise one or more additional formations for receiving corresponding digits of a person’s hand or hands.

[0019] The release / backing layer may comprise two formations arranged to provide a tactile indication to a user as to the correct implementation of one or more operational steps in the utilization of the ostomy body fitment. The two formations may be diametrically opposed. One or more formations (or each formation) may be shaped to receive part of a thumb of a user’s hand. One or more (or each) formation may be egg shaped. One or more (or each) formation may be hemispherical or bowl shaped. One or more (or each) formation may comprise different depths and may be deepest at a position proximate the intended location of an adjacent edge of the adhesive pad when affixed to the release / backing layer. One or more (or each) formation may become shallower in a direction away from the intended location of an adjacent edge of the adhesive pad when affixed to the release / backing layer.

[0020] One or more or each formation may be a depression. Each depression may have a length of between 5mm and 20mm, a width of between 3mm and 10mm, and a maximum depth of between 0.1mm and 0.5mm.

[0021] Accordingly, in one preferred embodiment, there is provided a release layer for an ostomy body fitment, the ostomy body fitment comprising an adhesive pad for forming a seal between an ostomy appliance and a stoma of an ostomate through one or more operational steps, the release layer comprising a formation for receiving part of a digit of a person’s hand; wherein the formation is positioned such that, when the adhesive pad is supported by the release layer, the formation is proximate an edge of the adhesive pad and provides a tactile indication to a user as to the correct implementation of one or more operational steps in the utilization of the ostomy body fitment; and wherein the formation is a depression.

[0022] At least part of the release / backing layer may be raised relative to a base of the release / backing layer. The formation may be provided in a surface which is raised relative to a base of the release / backing layer.

[0023] At least part of the release / backing layer may be inclined to support at least part of an adhesive pad in a correspondingly inclined position such that part of the adhesive pad is raised relative to the rest of the adhesive pad. Accordingly, a second aspect of the invention provides a release / backing layer for an ostomy body fitment, the ostomy body fitment comprising an adhesive pad for forming a seal between an ostomy appliance and a stoma of an ostomate through one or more operational steps, wherein at least part of the release / backing layer is inclined to support at least part of the adhesive pad in a correspondingly inclined position such that part of the adhesive pad is raised relative to the rest of the adhesive pad.

[0024] Advantageously, the inclination of the release / backing layer serves to indicate to a user of the ostomy body fitment the direction in which the adhesive pad should be rolled and the side of the adhesive pad that should be affixed to the ostomate. For example, the inclination of the release / backing layer can mimic or replicate the direction in which a stoma projects from the body of an ostomate and, hence, provide a visual indication to a user that the lower surface of the adhesive pad affixed to the release / backing layer should likewise be affixed to the body of the ostomate.

[0025] The inclined part of the release / backing layer may be arranged to support a lip of a stomal aperture of the adhesive pad in a raised position relative to the rest of the adhesive pad. The inclined part of the release / backing layer may be arranged such that a face of the lip of the stomal aperture is angled relative to the central axis of the stomal aperture when the adhesive pad is arranged on the release / backing layer. The release / backing layer may be shaped to support the stomal aperture in a raised position relative to the rest of the adhesive pad when the release / backing layer is arranged in a horizontal position. The release / backing layer may be shaped to mimic the direction in which a stoma extends from the abdominal wall of an ostomate.

[0026] The release / backing layer may comprise a rigid material. The release / backing layer may comprise a surface upon which the adhesive pad may be supported and wherein one or more formations is formed in the surface. One or more formations may comprise a depression formed in a surface of the release / backing layer. One or more formations may comprise a hole extending through the release / backing layer.

[0027] Accordingly, in one preferred embodiment, there is provided a release layer for an ostomy body fitment, the ostomy body fitment comprising an adhesive pad for forming a seal between an ostomy appliance and a stoma of an ostomate through one or more operational steps, the release layer comprising a formation for receiving part of a digit of a person’s hand; wherein the formation is positioned such that, when the adhesive pad is supported by the release layer, the formation is proximate an edge of the adhesive pad and provides a tactile indication to a user as to the correct implementation of one or more operational steps in the utilization of the ostomy body fitment; and wherein the formation is a hole.

[0028] A third aspect of the invention provides an ostomy body fitment comprising a release / backing layer according to the first or second aspects and an adhesive pad for forming a seal between an ostomy appliance and a stoma of an ostomate. The adhesive pad may be affixed to the release / backing layer on a skin-facing surface of the adhesive pad. The adhesive pad may be positioned relative to the release / backing layer such that a formation is positioned within the boundary of a stomal aperture of the adhesive pad. The adhesive pad may be positioned relative to the release / backing layer such that the formation is proximate an edge of a stomal aperture of the adhesive pad.

[0029] A fourth aspect of the invention provides a container for an ostomy body fitment comprising a release / backing layer according to the first aspect or the second aspect. The release / backing layer may form part of a base of the container.

[0030] A fifth aspect of the invention provides a method of manipulating an adhesive pad on a release / backing layer according to the first aspect or the second aspect comprising the steps of placing a digit of a hand in a formation of the release / backing layer and urging the digit toward the adhesive pad. The method may comprise urging the digit towards the adhesive pad and rolling the adhesive pad, for example rolling an inner edge of the adhesive pad outwardly. The method may comprise urging the digit towards the adhesive pad and lifting at least part of the adhesive pad away from the release / backing layer. The method may comprise placing a digit in a formation of the release / backing layer that is proximate an edge of a stomal aperture of the adhesive pad and urging the digit towards the adhesive pad to manipulate the adhesive pad.

[0031] A sixth aspect of the present invention provides a method of manufacturing a release / backing layer for an ostomy body fitment comprising the steps of providing a material, shaping the material to form a central region that extends along a different plane from an outer region of the material such that a surface of the material is inclined between the central region and the outer region, and shaping a surface of the central region to provide a formation in the surface for receiving part of a digit of a person’s hand. The formation may be positioned such that, when an adhesive pad of an ostomy body fitment is supported by the release / backing layer, the formation is proximate an edge of the adhesive pad. The formation may be shaped to provide a tactile indication to a user as to the correct implementation of one or more operational steps in the utilization of the ostomy body fitment.

[0032] The material may comprise plastics material. The material may comprise a solid sheet of material or a plurality of pellets. The step of shaping may comprise injection moulding or vacuum forming. The method may comprise the additional step of affixing the adhesive pad to a surface of the release / backing layer. The part of the adhesive pad affixed to the surface of the release / backing layer may be a skin-facing surface of the adhesive pad. The adhesive pad may be affixed to the release / backing layer such that the formation is proximate an edge of the adhesive pad. The method may comprise the step of shaping the central region to provide one or more additional formations in a surface thereof.

[0033] One or more formations (or each formation) may be shaped to receive part of a thumb of a user’ s hand. One or more (or each) formation may be egg shaped. One or more formations may comprise a depression formed in a surface of the release / backing layer. One or more formations may comprise a hole extending through the release / backing layer.

[0034] The skilled person will appreciate that except where mutually exclusive, a feature described in relation to any one of the aspects, embodiments or examples described herein may be applied to any other aspect, embodiment, or example. Furthermore, except where mutually exclusive, any feature described herein may be applied to any aspect and / or combined with any other feature described herein. Brief Description of the Drawings

[0035] In order that the invention may be more clearly understood one or more embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, of which:

[0036] Figure 1 shows a perspective view of a schematic representation of an existing ostomy body fitment;

[0037] Figure 2 shows a perspective view of a render of an existing ostomy body fitment being manipulated by a user to shape a stomal aperture; Figure 3 shows the ostomy body fitment of Figure 2 when applied to the body of an ostomate such that the stoma of the ostomate extends through the stomal aperture;

[0038] Figure 4 shows a perspective view of a schematic representation of an ostomy body fitment comprising a backing layer according to the present invention;

[0039] Figure 5 shows a side view in cross-section of the container and ostomy body fitment shown in Figure 4;

[0040] Figure 6 shows a plan view of the backing layer shown in Figure 4;

[0041] Figure 7 shows a plan view of the container and ostomy body fitment shown in

[0042] Figure 4;

[0043] Figure 8 shows a perspective view of the ostomy body fitment housed within the container of Figure 4 and covered by a foil seal;

[0044] Figure 9 shows a perspective view of a container and ostomy body fitment of another embodiment of the present invention; and

[0045] Figure 10 shows a perspective view of a container and ostomy body fitment of another embodiment of the present invention.

[0046] Detailed Description of the Invention

[0047] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of various embodiments and the inventive concept. However, those skilled in the art will understand that the present invention may be practiced without these specific details or with known equivalents of these specific details, that the present invention is not limited to the described embodiments, and that the present invention may be practiced in a variety of alternative embodiments. It will also be appreciated that well known methods, procedures, components, and systems may have not been described in detail.

[0048] In the following description, reference to “skin-facing” and “pouch-facing” should be taken to be in relation to the body of a user or “ostomate” of an ostomy body fitment, unless otherwise stated. For example, a skin-facing layer should be taken to be the layer intended to be affixed or attached to the skin of the ostomate, and a pouchfacing layer should be taken to be the layer intended to face away from the body of the ostomate when the skin-facing layer is affixed to the skin of the ostomate. In addition, in the following description, reference to “lower” and “upper” should be taken to be in relation to a substantially horizontal surface, unless otherwise stated. For example, a lower side should be taken to be the side resting on or facing the horizontal surface, and an upper side should be taken to be the side facing away from the horizontal surface.

[0049] Finally, reference to a backing layer will be understood as reference to a release layer, since in use the user completely removes the adhesive pad 101 from the backing layer 119.

[0050] Referring to Figure 4, there is shown an ostomy body fitment comprising an annular shaped adhesive pad 101 that is supported on a backing layer 119 in a substantially horizontal arrangement. The adhesive pad 101 comprises a tri-laminate structure composed of a skin-facing adhesive layer, a middle substrate layer, and a pouch- facing adhesive layer. The adhesive pad 101 defines a circular stomal aperture 105 through its centre. The adhesive pad 101 comprises a mouldable material that allows the shape and, hence, the diameter of the stomal aperture to be adjusted through physical manipulation of the adhesive pad 101. Examples of suitable materials for the adhesive layers includes those produced by ConvaTec under the brand names Durahesive® and Stomahesive®, which are generally tacky, putty-like, and substantially non-elastic, with low memory.

[0051] Referring in particular to Figure 6, the backing layer 119 comprises a substantially circular piece of rigid plastics sheet material which has been vacuum formed to create a raised portion 121 at its centre that comprises a substantially flat, circular region whose boundary is defined by dotted line 123. The sheet material is preferably between 0.1mm and 0.6mm in thickness. The raised portion 121 is surrounded by a ring-shaped portion 125 that tapers downwardly from the boundary 123 of the raised portion 121 to the outer edge 127 of the backing layer 119.

[0052] In the embodiment depicted, the inner and outer radii of the ring-shaped portion 125 of the backing layer 119 are substantially the same as the inner and outer radii of the corresponding adhesive pad 101. Accordingly, the adhesive pad 101 and the ringshaped portion 125 are substantially co-extensive when the adhesive pad 101 is supported by the backing layer 1 and appropriately aligned. As shown in Figure 5, when supported in this position, the inner edge or “lip” 113 of the stomal aperture 105 of the adhesive pad 101 encircles the raised portion 121 and its face 129 is angled relative to the central axis 131 of the stomal aperture 105. By angling the face 129 of the stomal aperture 105 in this way, a user of the adhesive pad 101 is given a visual and tactile indication as to the correct direction in which to roll the adhesive pad 101 to create a collar to encircle and hug a target stoma in use.

[0053] To provide a further visual and tactile guide to a user of the adhesive pad 101, the upper surface of the raised portion 121 comprises a pair of formations 133 on diametrically opposed sides of the raised portion 121. In the present embodiment, the two formations 133 each comprise an “egg-shaped” depression formed in the upper surface of the raised portion 121 with a concave contour that is shaped to approximately correspond to a part of the surface of a thumb or other digit of the hand of a user of the adhesive pad 101. Each depression 133 is formed proximate the boundary 123 of the raised portion 121 such that an edge of the fatter part of a depression 133 approximately coincides with the boundary 123 and tapers or narrows toward the centre of the raised portion 121. The depressions 133 have a variable depth and are each shallower toward the centre of the raised portion 121 and become deeper toward the boundary 123 of the raised portion 121. The deepest region of the depression 133 may be adjacent the boundary 123 of the raised portion 121. Advantageously, this may provide further tactile guidance to a user of the ostomy body fitment in encouraging movement of a digit in a direction from a shallower region of the depression 133 toward a deeper region 133. Each depression 133 has a length of between 5mm and 20mm, a width of between 3mm and 10mm, and a maximum depth of between 0.1mm and 0.5mm. In the embodiment depicted, a depression 133 has a length of 10mm, a width of 5mm, and a maximum depth of 0.5mm. It will be appreciated that other dimensions are possible depending on the shape and position of the or each depression 133 and also on the thickness of the backing layer 119.When the adhesive pad 101 is supported by the backing layer 119 and appropriately aligned, each depression 133 is likewise proximate the edge 113 of the stomal aperture 105 such that the boundary of a depression 133 approximately coincides with the edge 113 of the stomal aperture 105. As discussed, arranging the depressions 133 on opposite sides respectively of the raised portion 121 and proximate the edge 113 of the stomal aperture 105 provides a visual and tactile guide for a user in the correct use of the adhesive pad 101. The depressions 133 also serve to assist a user in catching the edge 113 of the stomal aperture 105 when initiating the rolling of the adhesive pad 101.

[0054] Since the adhesive pad 101 is intended to be rolled from the pouch-facing side such that the pouch-facing layer is rolled upon itself, the adhesive pad 101 is affixed to the backing layer 119 on its skin- facing adhesive layer. As depicted, the adhesive pad 101 and the backing layer 119 are arranged so as to be substantially concentric and such that the adhesive pad 101 is co-extensive with the ring-shaped portion 125 of the backing layer 119. As shown, in Figure 4, the combined adhesive pad 101 and backing layer 119 may be seated within a plastic tray 135 that is shaped to hold the two parts together in a substantially horizontal arrangement. Referring to Figure 8, a sheet of foil 137 may be provided across an open side of the tray 135 to seal the backing layer 119 and adhesive pad 101 in a sealed environment so as to protect the adhesive pad 101 until required to be used. One or more release liners (not shown) may be placed on the pouch-facing adhesive layer to provide an extra form of protection and also to provide further guidance in the correct usage of the adhesive pad 101 e.g., by providing printed indicia on the release layer(s) relating to the operational steps in installing the adhesive pad 101 in the correct manner.

[0055] Whilst the backing layer 119 of the above-described embodiment is separate and distinct from the tray 135, it will be appreciated that the backing layer could alternatively be incorporated into the base of the tray 135. For example, the base of the tray 135 could comprise a raised portion in a central region thereof that projects upwardly and sits proud of the surrounding portion of the base. In this way an inclined surface may be formed around the raised portion that may serve to directly support an adhesive pad and angle the pad in a corresponding fashion so that the edge of the stomal aperture is angled in the direction of the intended roll. As in the above-described embodiment, one or more formations may be provided in the upper surface of the raised portion proximate its boundary such that the one or more formations are proximate the edge of the stomal aperture when supported thereon for visual and tactile guidance in the correct installation procedure of the adhesive pad.

[0056] Whilst the above embodiments describe and depict a disc shaped adhesive pad 101 it will be appreciated that the adhesive pad may have a different shape such as square, hexagon, pentagon, squircle, star, rectangle, or oval, provided there is a surface through which a stomal aperture of appropriate size may be defined and expanded, and also provided there is sufficient surface area to ensure good contact with the body of an ostomate. Furthermore, whilst the above embodiments describe and depict an adhesive pad that is substantially planar, it will be appreciated that part or all of the adhesive pad may comprise a convex or concave contour, which may be shallow or deep depending on the anatomy of the stoma. These options may be desirable when used on an ostomate with a retracted stoma or a stoma that does not sufficiently protrude from the abdominal wall to extend through the stomal aperture of a planar ostomy body fitment. The convexity or concavity of the ostomy body fitment may serve to push against the abdominal wall of an ostomate and urge the stoma into a more protruded position for the capture of the stomal aperture. In such an arrangement clarity to the user in terms of which side to apply to the skin is even more important. In each case, the shape and contour of the backing layer 119 will substantially match the shape and contour of the adhesive pad so that the adhesive pad mates with and is supported by the backing layer 119 in the desired arrangement.

[0057] Although in the present embodiment a depression 133 is shaped to receive part of a digit of a hand of a user, it will be apparent to the skilled person that other suitable shapes and positions may be adopted that achieve the same objective of providing a visual and tactile guide to the user as to the correct utilization of the adhesive pad 101. For example, a formation 133 may alternatively comprise a circular or oval shape, or a ring-shaped depression or “trench” that extends around all or part of the raised portion 121 proximate the boundary 123 or even a hole rather than a depression that extends entirely through the backing layer 119 from the upper surface to the lower surface. Referring to Fig. 9 in an alternative embodiment, the two depressions 233 of the backing layer 219 need not be diametrically opposed and could instead be relatively arranged at any position within the raised portion 221 that falls, in use, within the stomal aperture 205 of the adhesive pad 201, e.g., offset by 90 degrees instead of 180 degrees. In a further alternative embodiment shown in Fig. 10, the formation may comprise a single bowl-shaped or hemispherical depression 333 that has an entire edge proximate the edge of the stomal aperture 305, in use. Accordingly, in this alternative embodiment, the formation 333 may have a substantially circular circumference with a diameter approximately equal to the diameter of the stomal aperture 305. As discussed, the ostomy body fitment is preferably installed according to a process comprising multiple sequential steps that result in the diameter of the stomal aperture being increased in size and the formation of a collar encircling the stomal aperture 105. Where the adhesive pad 101 is contained within a sealed tray 135, in a first step, the foil sheet 137 is removed to allow access the adhesive pad 101. Then, in a second step, a user inserts a digit of each hand (preferably the thumb) into a corresponding depression 133 and urges their digits outwardly so as to catch the edge 113 of the stomal aperture 105 of the adhesive pad 101. The user may continue this motion so as to urge the adhesive pad 101 away from the backing layer 119 and roll the adhesive pad 101 upon itself along the pouch-facing adhesive layer to form a collar.

[0058] When the stomal aperture 105 has been increased to a diameter that approximately corresponds to the diameter of a target stoma and a collar has been formed that projects away from the pouch-facing side, in a third step, the user completely removes the adhesive pad 101 from the backing layer 119 and applies the adhesive pad 101 to the ostomate such that the skin-facing adhesive layer is affixed to the skin of the ostomate and the stomal aperture 105 encircles the target stoma. In this position, the previously formed collar projects away from the body of the ostomate and extends along the external wall of the stoma with a snug, hugging contact. In a fifth and final step, an ostomy pouch is affixed to the pouch-facing adhesive layer of the adhesive pad 101 to form an ostomy appliance for the collection of excreted waste from the stoma. Accordingly, a seal is formed between the ostomy appliance and the stoma such that waste is excreted into the pouch from the stoma without leakage.

[0059] The one or more embodiments are described above by way of example only. Many variations are possible without departing from the scope of protection afforded by the appended claims.

Claims

CLAIMS1. A release layer for an ostomy body fitment, the ostomy body fitment for forming a seal between an ostomy appliance and a stoma of an ostomate through one or more operational steps, the release layer comprising a formation formed in a surface thereof for receiving part of a digit of a person’s hand and wherein the formation is positioned such that, when an ostomy body fitment is supported by the release layer, the formation is proximate an edge of the ostomy body fitment and provides a tactile indication to a user as to the correct implementation of one or more operational steps in the utilization of the ostomy body fitment.

2. The release layer as claimed in claim 1 wherein the formation comprises a depression formed in a surface of the release layer or a hole extending through the release layer.

3. The release layer as claimed in claim 1 or claim 2, wherein the formation is positioned proximate an edge of a stomal aperture of the ostomy body fitment when the ostomy body fitment is supported by the release layer.

4. The release layer as claimed in any preceding claim, wherein the formation has a length of between 5mm and 20mm and / or a width of between 3mm and 10mm and / or a maximum depth of between 0.1mm and 0.5mm.

5. The release layer as claimed in any preceding claim, further comprising one or more additional formations for corresponding digits of a person’s hand or hands.

6. The release layer as claimed in claim 5, comprising two diametrically opposed formations arranged to provide a tactile indication to a user as to the correct implementation of one or more operational steps in the use of the ostomy body fitment.

7. The release layer as claimed in any preceding claim, wherein one or more formations are shaped to receive part of a thumb of a user’ s hand.

8. The release layer as claimed in any preceding claim, wherein at least part of the release layer is inclined to support at least part of an ostomy body fitmentin a correspondingly inclined position such that part of the ostomy body fitment is raised relative to the rest of the ostomy body fitment.

9. The release layer as claimed in claim 8, wherein the inclined part of the release layer is arranged to support a lip of a stomal aperture of the ostomy body fitment in a raised position relative to the rest of the ostomy body fitment.

10. The release layer as claimed in claim 8 or claim 9, wherein the inclined part of the release layer is arranged such that a face of the lip of the stomal aperture is angled relative to the central axis of the stomal aperture when the ostomy body fitment is arranged on the release layer.

11. The release layer as claimed in any of claims 8 to 10, wherein the release layer is shaped to support the stomal aperture in a raised position relative to the rest of the ostomy body fitment when the release layer is arranged in a horizontal position.

12. The release layer as claimed in any preceding claim, wherein the release layer is shaped to mimic the direction in which a stoma extends from the abdominal wall of an ostomate.

13. The release layer as claimed in any preceding claim, wherein the release layer comprises a rigid material.

14. The release layer as claimed in any preceding claim, wherein the release layer comprises a surface upon which the ostomy body fitment may be supported and wherein one or more formations is formed in the surface.

15. The release layer as claimed in any preceding claim, wherein the formation is positioned to sit within the boundary of a stomal aperture of the ostomy body fitment when the ostomy body fitment is supported by the release layer.

16. The release layer as claimed in claim 15 wherein the formation provides a recess that lies below the interfacing surfaces of the adhesive pad and release / backing layer.

17. An ostomy body fitment comprising an adhesive pad and a release layer as claimed in any preceding claim, wherein the adhesive pad is affixed to the release layer on a skin-facing surface of the adhesive pad.

18. A container for an ostomy body fitment comprising a release layer as claimed in any preceding claim.

19. The container as claimed in claim 18, wherein the release layer forms part of a base of the container.

20. A method of manipulating an adhesive pad on a release layer as claimed in any of claims 1 to 16 comprising the steps of placing a digit of a hand in a formation of the release layer and urging the digit toward the adhesive pad to roll an inner edge of the adhesive pad outwardly and lift at least part of the adhesive pad away from the release layer.

21. A method of manufacturing a release layer for an ostomy body fitment comprising the steps of providing a sheet of material, shaping the sheet of material to form a central region that extends along a different plane from an outer region of the sheet of material such that a surface of the sheet of material is inclined between the central region and the outer region, and shaping a surface of the central region to provide a formation in the surface for receiving part of a digit of a person’s hand.

22. The method as claimed in claim 21, wherein the formation is positioned such that, when an adhesive pad of an ostomy body fitment is supported by the release layer, the formation is proximate an edge of the adhesive pad.

23. The method as claimed in claim 21 or claim 22, wherein the formation is shaped to provide a tactile indication to a user as to the correct implementation of one or more operational steps in the utilization of the ostomy body fitment.

24. The method as claimed in any one of claims 21 to 23, further comprising the step of affixing the adhesive pad to a surface of the release layer.

25. The method as claimed in claim 24, wherein the adhesive pad is affixed to the release layer such that the formation is proximate an edge of the adhesive pad.

26. The method as claimed in any one of claims 21 to 25, further comprising the step of shaping the central region to provide one or more additional formations in a surface thereof.

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