An ostomy appliance

Abstract

A method of manufacturing an ostomy appliance and an ostomy appliance, including a main body, which defines a waste collecting volume, and has a stoma opening that provides an entrance to the collecting volume, and a cover, which provides a cover layer for the main body, and is connected to the main body by a frangible connection.

Description

[0001] An Ostomy Appliance

[0002] FIELD

[0003] Embodiments of the invention relates to an ostomy appliance.

[0004] BACKGROUND

[0005] Ostomy appliances (also known as ostomy pouches or ostomy bags) are well known medical devices for users that have a stoma. Generally, the appliance has an opening for the stoma to be received in and an adhesive member that contacts the body and holds the appliance in position. Waste exiting the stoma is collected in a collecting volume, which is formed from two flexible walls connected together. Often the appliance includes an outlet valve, so that a user can empty waste that is collected in the collecting volume without having to remove and dispose of the entire appliance.

[0006] Ostomy appliances often have an integrated cover layer that is permanently attached during manufacture. However, not all users wish to have a cover on their appliance or alternatively they may wish to have a choice of what cover to have on their appliance.

[0007] Embodiments of the present invention seek to alleviate one or more problems associated with the prior art.

[0008] BRIEF DESCRIPTION OF THE INVENTION

[0009] In accordance with a first aspect of the invention we provide an ostomy appliance, including a main body, which defines a waste collecting volume, and has a stoma opening that provides an entrance to the collecting volume, and a cover, which provides a cover layer for the main body, and is connected to the main body by a frangible connection.

[0010] The main body may be formed from a first wall and a second wall which may be attached about their peripheries.

[0011] The frangible connection may extend around a part of the periphery of the cover and main body (i.e. along a seam between the first and second walls that defines the waste collecting volume).

[0012] At least one portion of contact material may be attached to the first wall. Optionally, wherein the contact material may be or may include at least one of: a non-woven material, nylon, and a hook or loop fastener material.

[0013] The contact material may be located on and / or adjacent the periphery of the first wall. The contact material may have a higher melting temperature than the first and second wall. The cover may be formed of or may include a material which has a higher melting temperature than the first and second walls. The cover may be formed from a non-woven material. Optionally, the cover may be embossed.

[0014] The cover may be unconnected to the main body in an upper region. This may allow the unconnected portion of the cover to be selectively moved to inspect inside the collecting volume. The unconnected portion of the cover may include a hook-and-loop fastener to hold the cover over the upper region of the main body.

[0015] The ostomy appliance may further include an outlet which provides an exit for waste from the waste collecting volume.

[0016] A second cover may be attachable to the main body of the appliance after the frangible connection between the main body and the cover is broken. At least one portion of contact material may be attached to the second wall and forms a main body connection formation for attaching the second cover to the main body.

[0017] In accordance with a second aspect of the invention we provide a method of manufacturing an ostomy appliance, the method including the steps of: providing a main body, which provides a waste collecting volume, and has a stoma opening that provides an entrance to the collecting volume, providing a cover, and forming a frangible connection between the cover and the main body.

[0018] Forming a frangible connection may include welding the main body to the cover. Optionally, wherein welding may include an RF welding process.

[0019] The method may further include the step of: cutting around the outside of the frangible connection. Optionally, wherein the cutting step may occur simultaneously with forming the frangible connection.

[0020] Providing a main body may include positioning a first layer of main body material on top of a second layer of main body material. Providing a cover may include positioning a cover layer on top of the first layer. The method may include preparing the first layer prior “providing the main body”. Preparing the first layer may include attaching a contact material with a higher melting point than the first layer to the first layer. The attachment may be in the region of the frangible connection. Optionally, attaching the contact material may include bonding to a surface of the first layer.

[0021] The contact material may be or may include at least one of: a non-woven material, nylon, and hook or loop material.

[0022] The method may further include: inserting a barrier layer between a portion of the first layer and a portion of the cover layer, which prevents a connection between the main body and the cover.

[0023] The cover layer may be a non-woven material.

[0024] In accordance with a third aspect of the invention we provide an ostomy appliance in accordance with the first aspect of the invention which is manufactured with any of the steps outlined in accordance with the second aspect of the invention.

[0025] BRIEF DESCRIPTION OF THE FIGURES

[0026] In orderthatthe present disclosure may be more readily understood, preferable embodiments thereof will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0027] Figure 1 a and 1 b illustrate rear and side cross-sectional views of a cover,

[0028] Figure 2a and 2b illustrate front and side cross-sectional views of a main body of an ostomy appliance,

[0029] Figure 3 is a side cross-sectional view of an ostomy appliance,

[0030] Figures 4 and 5 illustrate rear views of a cover,

[0031] Figures 6a and 6b illustrate front and side cross-sectional views of a main body of an ostomy appliance,

[0032] Figures 7a and 7b illustrate front and side cross-sectional views of a main body of an ostomy appliance,

[0033] Figures 8a, 8b, 9a, and 9b illustrate rear and side cross-section views of a cover,

[0034] Figure 10 illustrates a front view of a main body,

[0035] Figure 11 illustrates a front view of a main body during a manufacturing process,

[0036] Figures 12 and 13 illustrate front views of a main body,

[0037] Figure 14 is a blown up view of layers within the ostomy appliance during manufacturing, and Figure 15 is a flow diagram illustrating a method of manufacture of an ostomy appliance. DETAILED DESCRIPTION OF THE DISCLOSURE

[0038] Referring to figures 1 to 3, an ostomy appliance 1 for receiving and storing waste from a stoma is described. The ostomy appliance includes a main body 10 and a cover 30.

[0039] The main body 10 includes a stoma opening 12, a waste collecting volume 14 (also collecting volume 14) and a first engagement formation. In embodiments, the main body 10 is formed a first wall 16 and a second wall 18 to define the collecting volume 14. In the present example, the walls 16, 18 are connected about their periphery to form the waste collecting volume 14.

[0040] In embodiments, each of the first and second wall 16, 18 is manufactured from a film I plastic layer. It should be appreciated that there may be intermediate layers within the waste collecting volume 14 (this may assist with directing liquid and solid waste while allowing gases to travel a different path). However, the waste collecting volume 14 will always be defined by a wall (or two I more walls connected together) around the outside to form a pouch I bag in which waste will collect before the appliance is emptied or disposed of.

[0041] In the present example, the main body 10 has a non-body side (i.e. a first side), which, in use, faces away from the user (in the illustrated example, the non-bodyside is the first wall 16). The main body 10 also has an opposing (body) side (i.e. a second side), which, in use, faces the user (in the illustrated example, the body side is the second wall 18).

[0042] In some embodiments, the main body 10 includes an adhesive member 20 for attachment to the user’s body. The adhesive member 20 aligns with the stoma opening 12 and adheres the main body 10 to the user’s abdominal region around a stoma (such that the exit of the stoma is in fluid communication with the waste collecting volume 14). The adhesive member 20 may be a hydrocolloid wafer or similar that is known in the ostomy pouch area.

[0043] Alternatively, the main body 10 could include a connection mechanism located around the stoma open 12. A separate adhesive member would include a corresponding connection mechanism, so that the adhesive member can be connected to the user in isolation from the main body 10 (and collecting volume 14). Once the separate adhesive member is in position on the user, the main body 10 can then be connected to the adhesive member via the connection mechanism (although of course the connection mechanism could be connected prior to attachment to the user’s body). In either case, this allows the main body 10 to be exchanged more regularly than the adhesive member if desired since it can be disconnected from the separate adhesive member.

[0044] In some embodiments, the main body 10 includes an outlet portion (not shown), which has a closed state and an open state. The outlet portion has an opening that is selectively open and shut as desired. When the outlet portion is in its closed state, the main collecting volume 14 is closed and waste is held within the main body 10. When the outlet portion is in its open state, a flow path between the waste collecting volume 14 and outside of the appliance is provided. In otherwords, waste is able to pass out of the outlet portion.

[0045] In embodiments, the outlet portion may be provided by an elongated neck part that folds multiple times to close I unfolds to open a channel between the waste collecting volume 14 and the outside. In embodiments, the outlet portion may be provided by a valve part that includes stopper or closure mechanism to selectively open I close the waste collecting volume 14.

[0046] The cover 30 is configured to connect to the main body and provides a cover over the main body 10. In other words, the cover 30, in use, covers the front of the main body 10 (i.e. over the front of first wall 16 / over the non-bodyside side of the main body 10).

[0047] The cover 30 includes a second engagement formation. Thus, the cover 30 is connectable via engagement between the first and second engagement formations to the main body 10.

[0048] The first and second engagement formations will now be discussed in detail. In some embodiments, one of first and second engagement formations forms a receiving formation 50 and the other of the first and second engagement formations forms a projection formation 70. In the illustrated examples, the first engagement formation forms the receiving formation 50 (i.e. on the main body 10) and the second engagement formation forms the projection formation 70 (i.e. on the cover 30).

[0049] In some embodiments (see figure 2a and 2b), the receiving formation 50 provides a pocket 52 that is sized to receive the projection formation 70 (or at least a part of it). As can be seen from the illustrated examples, the receiving formation 50 is provided on the first wall 16 of the main body 10 (in otherwords, the receiving formation 50 is provided on the non-bodyside of the main body 10).

[0050] In the present example, the receiving formation 50 is formed from a layer (e.g. the same or similar material that the main body 10 is formed from) that extends across a portion of the main body 10. As can be seen in figure 2a, the layer extends across the width of the main body 10 - peripheral edges of the layer are connected to the first wall 16 (and may be included in the manufacturing process when the first and second walls 16, 18 are connected together). The pocket 52 is formed from the layer extending across the main body 10 - i.e. it is defined between the first wall 16 and the layer and includes one or more connections to the first wall 16 to determine the size of the pocket 52. In some embodiments (see, for example, figure 2a), the pocket 52 may include a pair of connections 52c to the main body 10 - these connections are spaced apart so as to provide the pocket 52 between (essentially, the connections 52c define the edge of the pocket 52). These connections 52c may be provided by welding or adhering the pocket layer to the first wall 16 of the main body 10. In the examples shown, the connections 52c are substantially straight and spaced apart from one another. As can be seen from the figures, the connections 52, taper slightly inwards towards a lower end of the pocket. This may make it easier to locate the projection formation 70 in the correct location (discussed in more detail later. However, it should be appreciated that the connections 52c could be generally aligned I parallel with each other or taper in the opposite direction as may be desired.

[0051] In some embodiments, the pocket 52 has an upper opening 52a (see, for example, all the figures showing a side profile of the main body 10). The upper opening 52a receives the projection formation 70 (illustrated in figure 3).

[0052] In some embodiments, the pocket 52 has a lower opening 52b (see figure 2b). The lower opening 52b allows liquid to drain from the pocket 52 (e.g. water could get caught in the pocket 52 when a user showers or swims - the lower opening 52b allows that water to drain away).

[0053] Now the cover 30 and the second engagement formation I projection formation 70 will be described. Essentially, the projection formation 70 is configured to be inserted into the receiving formation 50 - which supports the cover 30 in a position relative to the main body 10 (i.e. in front of the main body 10 to act as an outer layer of the appliance).

[0054] Similarly, to the main body 10, the cover 30 has a side that is configured to face the user / the main body 10 in use and another side that is outward facing I faces away from the body in use. In other words, the cover 30 has a front side 32 that, in use, faces away from a user and a second side 34, to which the upper attachment zone 72 connects (this second side 34 faces the main body 10 of the appliance in use). As can be seen in the figures, the projection formation 70 is positioned on the body facing side 34 of the cover 30.

[0055] In some embodiments, the projection formation 70 is attached to the cover 30 and extends to a free end 74. In other words, the projection formation 70 has an attachment zone 72 (in an upper portion) and extends (in the illustrated example, extends downwards) to the free end 74 (see figure 1a and 1 b). Essentially, the free end 74 is configured to insert into the pocket 52, so the projection extends downwards to insert into the upper opening 52a in the pocket 52.

[0056] The projection formation 70 could be formed / attach to the cover in multiple different ways. In some embodiments, the upper attachment zone 72 extends across a width of the cover 30 (see figure 1a). In other words, the projection formation 70 includes a layer of material that extends across the cover 30. The layer of material may extend across only a portion of the area of the cover 30 or it may extend across the entire of the cover 30 - three examples are illustrated in figures 1a, 4 and 5 (in each figure, the crosshatching indicates the projection formation 70). As can be seen in figure 1 a, the upper attachment zone 72 extends across the width of the cover 30. The upper attachment zone 72 extends generally horizontally across the cover 30 to provide a band that is connected to the second side 34.

[0057] In embodiments, the band is welded to the edges of the main body 10 - i.e. to the outer periphery 36. There maybe be one or more additional points I regions of welding I attachment across the cover 30. In other words, the upper attachment zone 72 could be attached to the cover 30 at two outer spaced regions or the attachment could extend substantially across the entire cover 30. A balance is found between providing structure to the connection between the projection formation 70 and the cover 30 (more welding I connection zones will likely result in a stiffer cover 30) and the level I integrity of the attachment.

[0058] As can be seen in figure 4, the upper attachment zone 72 extends across the upper portion of the cover 30. In this example, the entire upper attachment zone 72 may be attached to the cover 30 layer (e.g. to the second or back side 34) or the upper attachment zone 72 forms part of the outer periphery at the upper portion of the cover 30 and, thus, it may form a partial side of the cover 30 and be welded with other layers.

[0059] Alternatively, the projection formation 70 may be formed as the outer layer of the cover 30 and the upper attachment zone 72 may be attached to the outer periphery 36 of the cover 30. In some embodiments, the cover 30 is made from at least two layers (i.e. one provides the outer face of the first side 32 (the “front face”) and one provides the outer face of the second side 34 (the “back face”)). The at least two layers may be welded I attached about the periphery 36 to form the cover 30. The projection formation 70 may form part of one of those layers (i.e. the second side 34). It should be appreciated that the projection formation 70 could be formed by cutting a slit in a complete layer of the cover - the back layer could be welded about the entire periphery of the cover 30 and the layer may be cut in the desired shape to provide the projecting end 74 that is used to insert in the pocket 52.

[0060] As can be seen in figure 5, the upper attachment zone 72 is localised to a top part of the first engagement formation I projection formation 70. In this example, the projection formation 70 is attached to the back face of the cover 30 across the top part of the formation 70 and the projecting end 74 extends downwards from the top part. It should be appreciated that the upper attachment zone 72 could be attached to the cover 30 with a non-permanent attachment. In such an example, it would allow the projection formation 70 to be made from a material that may not wash well but provides advantageous structure for the ostomy appliance when used. This allows the removal of the projection formation 70 from the cover 30, so that the remainder of the cover 30 can be cleaned.

[0061] Essentially, the cover 30 includes on its second side 34, a formation that has a part that extends away from or is spaced from the remainder of the second side 34 and allows it to engage with the corresponding formation on the non-bodyside wall 16 of the main body 10.

[0062] In some embodiments, the projecting end 74 may be reinforced I stiffened I formed of a stiffer or thicker material (when compared to the remainder of the cover layers I material). This may make it easier to push it into the pocket 52. For example, one or more additional layers could be added or additional welding could be used to stiffen the projecting end 74.

[0063] The projecting part I end 74 may have different shapes. In some embodiments, the projecting end 74 is substantially trapezium in shape (i.e. the majority of each side is substantially straight and has one pair of generally parallel sides) and in this example, narrows towards the lower edge 74a (i.e. the furthest end from the upper attachment zone 72). In some embodiments, the free end 74 may include a transversely extending barb portion (not shown). The barb portion extends from a lateral edge 74b of the free end 74, outwards, so that when the free end 74 is inserted into the pocket 52, the barb portion is initially deflected inwards (towards a centrally axis of the projection formation 70) and returns to its original shape once in the pocket 52. Thus, the barb portion provides a resistance to the cover 30 being removed from the receiving formation 50 (which may prevent or reduce instances when the cover 30 becomes detached by accident). The free end 74 may include a pair of barb portions - each one extending in an opposing direction, so both lateral edges 74b of the free end 74 includes a barb portion extending transversely with respect to the cover 30 I projecting formation 70. An alternative to a barb portion could be providing a projecting part 74 that widens as it extends downwards towards the free end.

[0064] It should be appreciated that there may be more than one projecting part 74 that extends from the upper attachment zone 72. For example, there may be two projecting parts that are positioned adjacent one another. In such an embodiment, the receiving formation 50 on the main body 10 may include two corresponding pockets into which the projection formation 70 extends. Or, alternatively, one larger pockets that engages both projecting parts may be used.

[0065] In some embodiments, the cover 30 includes a securing region 78 for direct connection to at least one of: the main body 10, an adhesive member 20, or a body of the user (illustrated in figure 1a). In the illustrated example, the securing region 78 connects to the top of the adhesive member and the top of the main body 10 is covered. In embodiments, the securing region 78 includes a fastener that cooperates with a corresponding fastener on the adhesive member 20 or main body 10. In some embodiments, the securing region 78 includes a section of hook-and-loop fastener, which cooperates with a corresponding section of hook-and-loop fastener on the adhesive member 20 or main body 10. It should be appreciated that this may not be the case (especially if, for example, it is desired for the cover 30 to connect directly to skin) and the securing region 78 may include adhesive, skin friendly adhesive, gecko tape, or other fastener to secure the top of the cover 30 in the “in use” position.

[0066] The general structure of the appliance and the engagement formations provided on the main body 10 and the cover 30 have been described above. It should be appreciated that the projection formation 70 and the receiving formation 50 could be provided in different ways - the below description provides examples of how the appliance may be constructed (particularly with reference to other features the appliance provides). Nevertheless, it should be appreciated that this specific structure does not need to be followed in order to provide the engagement formations outlined above. Further, any of the described cover 30 features could be combined with any of the main body 10 features described.

[0067] As mentioned above, the first and second wall 16, 18 define the collecting volume 14. With particular reference to figure 7a, the ostomy appliance further includes an intermediate wall 104, an outer wall 106, an outer attachment zone 110 and an inner attachment zone 112.

[0068] The intermediate wall 104 is positioned inside the collecting volume 14. In some embodiments, a gas permeable filter 120 is provided. In the illustrated example, the filter 120 is provided on the non-bodyside wall I first wall 16 (and more preferably, the filter 120 is positioned in an upper part of the first wall 16). The intermediate wall 104 provides one or more openings / perforations between the collecting volume 14 and an upper chamber 122. This permits gas to pass through the intermediate wall 104 and out to atmosphere through the filter 120.

[0069] In other words, the intermediate wall 104 provides a cover to the filter 120 that reduces waste build up next to or on the filter 120 while still allowing waste gases to escape (if the gas becomes trapped then the ostomy appliance may balloon, which may not be discrete or pleasant to use).

[0070] In the illustrated example, the intermediate wall 104 extends from a top portion of one wall (in this case, the second wall 18) down to a mid-section of the opposing wall (in this case, the first wall 16). As can be seen in figure 7b, the intermediate wall 104 is attached to the body side wall 18 above the connection to the adhesive member 20. The waste from the stoma will enter the appliance through a stoma opening in the adhesive member 20 and flow downwards to the collecting volume 14. The intermediate wall 104 extends across the interior of the main body 10 and connects to the non-bodyside wall 16 below the filter 120.

[0071] The outer wall 106 is positioned outside the collecting volume 14. In other words, the outer wall 106 is external I on the outside of the first I second wall 16, 18. In this case, the outer wall 106 is provided on the front face of the main body 10 - i.e. on the first wall 16.

[0072] The outer wall 106 may form part of or provide the first engagement formation discussed above (i.e. the outer wall 106 provides the first engagement formation of the main body 10 for receipt of the corresponding second engagement formation of the cover 30). In other words, the outer wall 106 provides the receiving formation 50 into which the projection formation 70 inserts to connect the cover 30 to the main body 10.

[0073] The outer attachment zone 110 extends about the periphery of the first and second wall 16, 18. In other words, the outer attachment zone 110 is the peripheral attachment that seals the first and second wall 16, 18 together to form the main body 10 (typically, this is provided by a welded seam). The intermediate wall 104 is included in the seal around the upper portion of the main body 10. Thus, the intermediate wall 104 is clamped in the outer edge of the main body 10. Further, the outer wall 106 is also included in the outer attachment zone 110 to form a layer over the top of the first wall 16. In the illustrated embodiment, the outer wall 104 extends across the entire mid I lower portion of the main body 10. Thus, the outer wall 104 also forms an integral part of the main body 10.

[0074] The inner attachment zone 112 attaches the outer wall 106, the intermediate wall 104, and the first wall 16 together (in other words, the outer wall 106, intermediate wall 104 and first wall 16 are connected - through the “front” layers of the bag - while preserving the collecting volume 14 between the intermediate wall 104 and the second wall 18 behind). As illustrated in figure 7b, the bottom 104a of the intermediate wall 104 overlaps with the top 106a of the outer wall 106. Thus, in the overlap region 150, the inner attachment zone 112 can connect each of the outer wall 106, the intermediate wall 104 and the first wall 16.

[0075] In embodiments, the inner attachment zone 112 extends from each side of the main body 10 inwards towards a central longitudinal axis of the main body 10. As can be seen in figure 7a, there are two regions 112a of inner attachment zone 112 that extend across each side of the first wall 16 (substantially horizontally). Either side of the central axis, each of the two regions extends downwards 112b towards the bottom of the first wall 16. Lastly, a central region 112c connects the two downwardly extending regions 112b. The downwardly extending regions 112b of the inner attachment 112 extend past the bottom edge 104a of the intermediate wall 104. Therefore, part of the downwardly extending regions 112b and the central region 112c only attach the outer wall 106 to the first wall 16. This results in an opening between the intermediate wall 104 and the first wall 16 (i.e. between the downwardly extending regions 112b). Thus, the inner attachment zone 112 is formed such that a non-return valve mechanism is formed between the intermediate wall 104 and the first wall 16. In other words, the inner attachment zone 112 extends below the bottom edge 104a of the intermediate wall 104, such that a channel is formed between the bottom edge 104a of the intermediate wall 104 and the first wall 16.

[0076] Advantageously, the same attachment zone 112 and how it connects the outer wall 106 to the first wall 16 also allows the formation of the first engagement formation. In other words, the inner attachment zone 122 allows the formation of the non-return valve and the formation of the receiving formation 50. The shape of the attachment zone 112a, 112b, 112c on the outer wall 106 provides the pocket 52 of the receiving formation 50 (the connections 52c, 54 of the pocket 52 are included as references on figure 7a to illustrate that the same connection provides two distinct functions on different layers).

[0077] In some embodiments, the inner attachment zone 112 (the regions 112a that extend inwards form either side) is positioned at the top 106a of the outer wall 106. Thus, this portion forms the top of the receiving formation 50 - between the attachment zone 112a provides the upper opening 52a to the pocket 52. Where the attachment zone 112 extends downwardly (regions 112b), forms the sides 52c of the pocket 52 and the channel of the non-return valve on the interior of the main body 10. Lastly, the central region 112c provides the bottom of the pocket 52. The lower opening I drainage opening 108 is provided by an additional slit provided in the bottom of the pocket 52.

[0078] In some embodiments, the inner attachment zone 112 includes a further attachment 116. In the illustrated example, the further attachment 116 is positioned substantially centrally in the first wall 16. In some embodiments, the further attachment 116 is a single weld point (i.e. a spot weld that extends through the outer wall 106, the first wall 16, and the intermediate wall 104). In the illustrated example (see figure 7a), the outer wall 106 is cut to allow the further attachment 116 to extend through to the intermediate wall 104 without impacting the provision of the receiving formation 50. In other words, a portion 106b of the outer wall 106 is disconnected from the remainder of the wall 106, so that the pocket 52 is maintained. This allows the additional spot weld to be provided, which improves the non-return valve functionality of the intermediate wall 104. In the illustrated example, the disconnected portion 106b is generally triangular with rounded corners. It should be appreciated that the disconnected portion 106b could be any desired shape - the important aspect is that it permits the spot weld I further attachment 116 to extend through the outer wall 106 without impacting the pocket 52 provided. In all the examples discussed, the pocket 52 is provided on the front face of the main body 10 and the projection of the cover 30 is inserted into it. This encourages the main body 10 to maintain its shape even when connected to the cover. For example, if any of the connections extended through the entire main body 10 there would be a much greater risk that the shape of the appliance would distort as the waste collecting volume 14 filled with waste.

[0079] Further, the pocket 521 projection 74 extends over approximately a third of the width of the appliance - this provides a good (and in this case, central) anchor point between the main body 10 and the cover 30.

[0080] Figures 8a to 10 illustrate further embodiments of a cover and main body. The references used for the same or similar features as those already described above are the same with the addition of a “2” as a prefix - i.e. cover 30 becomes cover 230. The cover 230 illustrated could be used with the main body 10 already described - see figure 9a including a projecting formation 270 for inserting into the corresponding receiving formation 50 on the main body 10 discussed above. It should be appreciated that the main body 10 discussed above could include a main body connection formation that interacts with the cover 230 discussed below - further details are discussed further below.

[0081] For simplicity, figures 8a and 8b are provided with no projecting formation. In some embodiments, a cover 230 is provided. The cover 230 is attachable to the main body 10, 210 and provides a cover layer for the main body 10, 210.

[0082] The cover 230 includes a lower cover connection formation 242 and an upper cover connection formation 244. The lower cover connection formation 242 is located in a lower region of the cover 230 and the upper cover connection formation 244 is located in an upper region of the cover 230.

[0083] The cover 230 includes a flexible portion 238. The flexible portion 238 is formed between the lower cover connection formation 242 and the upper cover connection formation 244. The flexible portion 238 allows great flexibility of the cover 230 and particularly, encourages folding of the cover in a specific area. It should be appreciated that the flexible portion 238 is so called because of its relative flexibility compared to the parts of the cover 230 that have the upper and lower cover connection formations 242, 244. In effect, the flexibility is provided by the separation I gap between the connection formations 242, 244 (those portions are thicker / provide more material and are therefore less flexible). In other words, the flexible portion 238 is for folding the cover 230 during an attachment process in which the cover 230 is attached to the main body 10, 210. The gap provided between the connection formations 242, 244 encourages the cover 230 to be folded generally horizontally (as can be seen in the examples illustrated, this is used to encourage the cover to be folded in half with a gap provided generally in the middle of the length of the cover).

[0084] In some embodiments, the flexible portion 238 extends between the upper and lower cover connection formations 242, 244. In other words, the flexible portion 238 extends across the cover 230 (in the illustrated example in figure 8a, the flexible portion 238 extends generally transversely across the cover 230). Thus, in this example, the flexible portion 238 (or the extent of the flexible portion 238) is defined by a gap between the upper and lower cover connection formation 242, 244.

[0085] Following on from the above, in some embodiments, the lower cover connection formation 242 defines at least a part of an edge 238a of the flexible portion 238. Further, in some examples, the upper cover connection formation 244 defines at least a part of an (or another) edge 238b of the flexible portion 238.

[0086] In the illustrated examples, the upper cover connection formation 244 has two connection portions 244a and 244b. Each of the connection portions 244a, 244b is located on or adjacent a peripheral side of the cover 230. In other words, the cover 230 has a first and a second side 232, 234 (in line with that discussed above) and the connection portions 244a, 244b are spaced apart on the second side 234 of the cover 230.

[0087] In some embodiments, the upper cover connection formation 244 includes a fasteners that extends along a top profile of the cover. Although not shown in the figures, an additional top fastener is included in some embodiments. In this example, the additional top fastener is positioned on or adjacent the peripheral edge of the top of the cover. It should be appreciated that upper cover connection formation 244 may not be two or three distinct connection portions. Instead, the sides may be connected by a stretch of connector that follows the top profile of the cover in a single strip (or, alternatively, two side strips may be provided that extend across a portion of the top profile in addition to the side). An important aspect for usability of the cover 230 is that the two connection portions 244a, 244b are provided transversely across the cover 230 (as illustrated in figure 8a and 9a), so that the cover 230 is connectable to the main body 210 on either side.

[0088] In some embodiments, the lower cover connection formation 242 is configured likewise but on a lower region of the cover 230. Thus, the lower cover connection formation 242 has two connection portions 242a and 242b. Each of the connection portions 242a, 242b is located on or adjacent a peripheral side of the cover 230. In other words, the connection portions 242a, 242b are spaced apart on the second side 234 of the cover 230. It should be appreciated that lower cover connection formation 242 may not be two distinct connection portions as they may be connected by a stretch of connector that follows the bottom profile of the cover 230. An important aspect for usability of the cover 230 is that the two connection portions 242a, 242b are provided transversely across the cover 230 (as illustrated in figure 8a and 9a), so that the cover 230 is connectable to the main body 210 on either side.

[0089] As can be seen from figure 8a and 9a - the upper and lower cover connection formations 242, 244 are formed as two separate connection portions. Each of the portions 242a, 242b, 244a, 244b extends away from the flexible portion 238 (and follows the side peripheral edge of the cover 230).

[0090] In some embodiments, the lower cover connection formation 242 and I or the upper cover connection formation 244 include hook-and-loop type connector. Further, it may be preferable for the lower cover connection formation 242 and I or the upper cover connection formation 244 to be specifically hook type connectors, so that the corresponding connectors provided on the main body 10, 210 are loop type connectors. This improves the comfort to the user, since it reduces the risk that the connectors will get caught on clothing since the hook type connector (which are the connectors that may pull on fabrics comparatively more) are facing inwards / towards the body (and away from items of clothing).

[0091] As outlined above, the main body 210 has a first side and a second side (these are generally formed from the first and second wall (not labelled in figure 10 but the same as first and second walls 16, 18 that defines the main collecting volume). The main body connection formation 260 includes first and second connection portions 260a, 260b. Each of the connection portions 260a, 260b is located on or adjacent a peripheral side of the main body 210. In other words, the connection portions 260a, 260b are spaced apart on the first side of the main body 210. It should be appreciated that main body connection formation 260 may not be two distinct connection portions as they may be connected by a stretch of connector that follows the top profile of the main body 210 (an example of which is illustrated in figure 12). However, the important aspect for connection to the cover 230 described above is that the connection portions 260a, 260b are spaced transversely across the main body 210 (this is so they can engage and hold the upper and lower cover connection formations 242, 244 of the cover 230).

[0092] In some embodiments (see, for example, figure 10) the main body connection formation 260 extends from a bottom of the main body 210 to a top of the main body 210. In other words, the main body 210 has a substantially central longitudinal axis (not shown). The main body connection formation 260 has a portion that extends axially along and spaced from the longitudinal axis between the top and bottom of the main body 210.

[0093] As mentioned above, both the cover 230 and the main body 210 are compatible with the features discussed above in relation to cover 30 and main body 10. Essentially, the cover 270 could include a projection formation 70, 270 with one or more of the features discussed in relation to the projection formation 70, 270 above and the main body 210 could include a receiving formation 50 with one or more of the features discussed above in relation to the receiving formation 50. Further, the layers I configuration described with respect to figure 7a and 7b could also be combined with the features outlined above with respect to main body 210.

[0094] In an embodiment in which the cover 230 includes a projection formation 270, the upper attachment zone 272 is located in or adjacent to the flexible portion 238 (as illustrated in figure 9a). The location of the upper attachment zone 272 allows the free end 274 of the projection formation 270 to extend outwards from the cover 230 when the cover 230 is folded (as illustrated in figure 9b).

[0095] In use, this folding functionality alongside the positioning of the upper and lower cover connection formations 242, 244 allows a user to position and attach the cover 230 to the main body 210 more reliably I consistently in the correct position. In short, a connection process is as follows. The cover 230 is folded along the flexible portion 238. This fold exposes the free end of the projection formation 274, so that it is easily visible and its position is controllable. The free end 274 is inserted into the receiving formation on the main body 210 while the cover 230 remains folded. Once the projection formation 270 is in position in the pocket of the receiving formation, the upper cover connection formation 244 is engaged with the main body connection formation 260 (at this stage the cover 230 remain folded). Once the upper region of the cover 230 is successfully positioned, then the lower region of the cover (below the flexible portion 238) is unfolded towards the main body connection formation 260. The lower cover connection formation 242 is engaged with the main body connection formation 260. At this point the cover 230 is successfully positioned relative to the main body 210 and the cover 230 is reliably attached to the main body 210.

[0096] In an embodiment in which a projection formation and receiving formation are not present, the connection process is generally similar to the above but there is no need to locate I insert the projection formation into a receiving formation. Again, the folding functionality provided by the flexible portion 238 of the cover allows an easier process to ensure the cover is in the correct position and connected correctly to the main body 210.

[0097] The description below relates to an embodiment in which an ostomy appliance 301 has a frangible connection between the cover and main body (i.e. a single time disconnectable cover). The frangible connection, once broken, cannot be reformed, so the cover 30, 230 described above is equally able to interact I engage with a main body (as described below) after the cover has been removed. In other words, the frangible connection connects the cover to the main body and is breakable to enable the cover to be removed - the cover can only be removed once because once the connection is broken, it cannot be reconnected (i.e. it provides a single use disconnection and no reconnection is possible). With this in mind, the main body described below also includes one or more of the features described above that allow it to connect to a cover as above - this is in addition to being initially manufactured with an integrated cover. In particular, figures 10 to 14 relate to the ostomy appliance about to be described. The reference numbers used when describing embodiments below follow the same pattern as above - the same or similar features are given the same reference number with a preceding “3” - for example, main body 10 becomes main body 310.

[0098] In this example (see figure 14), the ostomy appliance 301 includes the main body 310 and a cover 400.

[0099] As above, the main body 310 defines a waste collecting volume, and has a stoma opening that provides an entrance to the collecting volume. As can be seen in figure 14 (which is a cross- sectional view through the ostomy appliance where layers of the appliance are shown unattached from each other for simplicity and clarity), the main body 310 has the first wall 316 and second wall 318. The first wall 316 and the second wall 318 are attached about their peripheries to form the waste collecting volume.

[0100] In some embodiments, an adhesive member (also known as a wafer) is connected to the main body around the stoma opening. Although it should be appreciated that some ostomy appliances are “two-piece” systems where an adhesive member can be repeatedly disconnected from I connected to the main body during use - such systems have appropriate connection mechanisms.

[0101] The cover 400 provides a cover layer for the main body 310 and is connected to the main body 310 by a frangible connection (in the present example, the cover 400 connects to the periphery of the first and I or second wall 316, 318 - i.e. on the periphery that connects the first and second walls 316, 318 together to form the collecting volume). As outlined above, the frangible connection is a permanent but breakable connection. Once the connection is broken (i.e. to remove the cover 400 from the main body 310), it cannot be reformed and the cover 400 cannot be reattached. In other words, the connection between the cover 400 and the main body 310 is firm enough to hold the cover 400 in position when the ostomy appliance is used normally but the connection is susceptible to breakage if the user decides they want to remove the cover 400 (for example, if they decide they want to use a cover 30, 230 as described above).

[0102] In some embodiments, the cover 400 is configured to overlay the entirety of the first wall 316.

[0103] In some embodiments, a contact layer I material is used under the cover 400 to provide I encourage the desired connection to the main body 310. In some examples, at least one portion of contact material 360 is attached to the second wall 318. In some embodiments, the contact material 360 has the one or more of the features of the main body connection formation 260 described above. In other words, in some examples (e.g. figure 10) the contact material 360 extends from the top to the bottom of the main body 310 either side of a central longitudinal axis. In more detail, the contact material extends along the periphery of the main body 310 (i.e. where the seam is formed between the first and the second wall 316, 318). In the example illustrated in figure 10, the contact material 360 is attached to the first wall 316 in two spaced regions in general alignment with the central axis. In the example in figure 12, the contact material 360 is attached to the first wall 316 around the entire periphery of the first wall 316. The example illustrated in figure 13 provides another option in which the contact material 360 is provided in a similar manner to that of figure 10 and another region of contact material 361 is provided in a top area of the first wall 316.

[0104] As mentioned above, figure 14 is a schematic illustration of the layers of the appliance - the contact material 36 overlays the first wall 316 and is positioned between the first wall 316 and the cover 400.

[0105] In some embodiments, the contact material 360 has a higher melting temperature I point than the first and second wall 316, 318. In other words, the material or combination of materials that forms the contact material 360 is chosen so that it melts at a different and higher temperature than the temperature that the material (or combination of materials) that forms the first and second walls 316, 318.

[0106] In some embodiments, the cover 400 is chosen likewise. In other words, the cover 400 is formed from a material or combination of materials that have a higher melting temperature than the melting temperature of the first and second walls 316, 318.

[0107] This choice of material selection makes it possible to form the ostomy appliance in one step. Essentially, a single welding step is used to form all of the seams of the appliance - a careful choice of welding temperature (or in the case of an RF welding step a selection of a setting that generates the appropriate temperature) ensures that the peripheral seams for the first and second walls 316, 318 are fully formed because the layers melt fully into each other. At the same time, because of the contact material 360 and cover 400 having a higher melting temperature, a frangible connection is formed where the materials connect through a bond but the connection is not fully realised - thus, a frangible connection is formed in which the cover 400 and the contact material 360 can be separated again through the implementation of opposing I pulling forces.

[0108] It should be appreciated that if the cover 400 is chosen in this way and connected with the welding outlined above and there is no contact material, then a stronger connection will be formed during manufacture between the cover 400 and the first wall 316. The connection will still be breakable but more force is needed to pull the layers apart because the first wall 316 will melt into the cover 400 more than it would if there was a contact material 360 present. It should be appreciated that this still forms a single time disconnectable cover. A preferred method of manufacture involving this welding process is described in more detail below.

[0109] In some embodiments, the material chosen for the contact material 360 and I or the cover 400 is or includes at least one of: a non-woven material, nylon, and a hook or loop fastener material.

[0110] For example, in some embodiments, the cover 400 is formed from a non-woven material. In such an embodiment, the front surface (i.e. facing away from the body in use) may be embossed to improve the feel I provide a nicer texture for a user wearing the ostomy appliance.

[0111] In some embodiments, the frangible connection between the cover 400 and the main body 310 extends around (at least a part of) the periphery. In other words, the frangible connection is on an edge of the cover 400 and main body 310.

[0112] In some embodiments, the frangible connection is not present in an upper region 402 of the ostomy appliance. In other words, the cover 400 is not bonded with a single use connection to the main body 310 at the top of the appliance (e.g. the cover 400 is unconnected to the main body 310 in an upper region 402). The unconnected portion of the cover 400 allows the cover 400 to be selectively moved to inspect inside the collecting volume. In other words, the first wall 316 (or at least the top portion of the first wall (see above with respect to figure 7a and 7b)) is transparent, so that when the cover 400 is shifted from the top part of the main body 310 the user can inspect their stoma and / or collecting volume contents (to ensure everything is working as expected).

[0113] In such an embodiment, at the top of the cover 400 an alternative connection means, between the cover 400 and the main body 310, is provided. The connection means is reusable, so that the cover 400 can be detached at the top region 402 (and the user can inspect the interior) and then the cover 400 can be reattached to the main body 310.

[0114] Thus, the unconnected portion of the cover 400 includes one or more hook-and-loop fasteners (not shown) to hold the cover 400 over the upper region 402 of the main body 310. As can be seen in the illustrated examples, the contact material 360 can provide the corresponding fasteners for the cover 400 to hold I connect to on the main body 310. Further, if the contact material 360 is formed from a loop material and / or a non-woven material then it provides one side of the hook-and-loop fastener outlined above.

[0115] As mentioned above, the configuration of the layers makes it possible to manufacture an entire ostomy appliance through a single step. Essentially, the method includes:

[0116] 1) providing a main body 310 (step 1000 in figure 15), 2) providing a cover 400 (step 1002), and

[0117] 3) forming a frangible connection between the cover 400 and the main body 310 (step 1004).

[0118] In more detail, step (1) includes positioning a first layer of main body material on top of a second layer of main body material. After the welding process is completed and an outer seam is formed in the first and second layers, the waste collecting volume is formed.

[0119] In some embodiments, prior to step (1), the first layer of main body material is prepared. In this present example, this involves attaching the contact material to the first layer. The contact material may be attached by bonding the contact material to a surface of the first layer. Therefore, when the first layer is arranged on top of the second layer, the contact material is positioned with respect to the cover layer so as to be able to form the frangible connection (as such, the region that forms the frangible connection has a higher melting temperature than the first and second layers).

[0120] In more detail, step (2) includes positioning a cover layer on top of the first layer. In embodiments where a contact material is also present, the cover layer is positioned on top of the contact material.

[0121] In more detail, step (3) includes welding the main body 310 (i.e. the first and second layers) to the cover 400 (i.e. the cover layer). The welding process allows an entire seam of the ostomy appliance to be formed at the same time - in other words, the boundary is formed at the same time. In some embodiments, the welding includes an RF welding process. Though it should be appreciated that other welding processes are available (e.g. heat welding) which are equally compatible with the method discussed.

[0122] In some embodiments, the method includes cutting around the outside of the frangible connection. In other words, the layers of the first wall 316, second wall 318, and cover 400 are welded together and then the profile of the ostomy appliance is cut out from the layers. In some embodiments, the cutting step occurs simultaneously with forming the frangible connection (i.e. simultaneously with completing the welding step, so the seams are formed and cut at the same time). In other words, step (3) also includes the step of cutting around the weld boundary formed, so a fully formed ostomy appliance is completed.

[0123] As discussed above, the frangible connection may not extend around the entire periphery of the main body 310. In such an embodiment, an additional step in the method of manufacture is required. A barrier 404 is positioned between a portion of the first layer 316 and a portion of the cover layer 400. In other words, there is an additional step between steps (1) and (2) discussed above in which a layer of additional material is added. The barrier 404 is positioned in the upper region 402 only. The purpose of the barrier 404 is to stop any connection being formed between the cover layer 400 and the first layer where the barrier 404 is positioned.

[0124] In some embodiments, the barrier 404 has a melting temperature above that of the first and second walls I layers 316, 318 and above that of the cover 400. Thus, when the welding process occurs, the barrier prevents any connection forming between the cover 400 and the main body 310 in the upper region 402. Once the welding and cutting steps are complete, the barrier 404 is removed and the cover 400 is unconnected in the desired region.

[0125] In some embodiments, where the frangible connection does not extend into the upper region of the appliance, additional fasteners are positioned and connected to the cover layer 400 prior to the cover layer 400 being positioned over the first layer 316.

[0126] The ostomy appliance constructed in the manner outlined with respect to figure 10 to 14 is advantageous in multiple ways. Once the frangible connection between the cover 400 and the main body 310 (i.e. the contact material 300) is broken, the contact material 310 is left exposed. The contact material 360 could be made with the same attributes as is discussed above in relation to the main body connection formation 260. This means that a cover 30, 270 as described above (i.e. a separate cover) is attachable. Further, the main body 310 could be formed with the receiving formation 50 described above, which allows complete flexibility for the user about what cover they wish to use. In some embodiments where additional contact material is provided (contact material 361 in figure 13, for example), a different material could be used if desired. For example, a stronger loop type fastener could be used to provide a stronger connection between the cover 30, 230, 400 and the main body 310 at the top of the appliance.

[0127] Further, since the cover 400 can be removed from the main body 310 if desired, a more economical material can be used. In other words, the user may have and wish to use their own separate cover (which may be one of: a thicker material, a material that is nicer to touch, formed of a woven material), which means they will remove the cover 400 and use their own. Whereas if it was not possible to remove the cover, then the material it was formed of would be required to be much nicer to touch and thus, there would be more waste because the upgraded non-removable coverwould have to be disposed of with every single appliance. In the current system, the higher quality cover, can be removed and used again. Further, the appliance in its initial form with the cover 400 connected can be used in that form if desired. Thus, this system allows the user multiple choices about how they wish to use their ostomy appliance.

[0128] When used in this specification and claims, the terms "comprises" and "comprising" and variations thereof mean that the specified features, steps or integers are included. The terms are not to be interpreted to exclude the presence of other features, steps or components. The invention may also broadly consist in the parts, elements, steps, examples and / or features referred to or indicated in the specification individually or collectively in any and all combinations of two or more said parts, elements, steps, examples and / or features. In particular, one or more features in any of the embodiments described herein may be combined with one or more features from any other embodiment(s) described herein.

[0129] Protection may be sought for any features disclosed in any one or more published documents referenced herein in combination with the present disclosure.

[0130] Although certain example embodiments of the invention have been described, the scope of the appended claims is not intended to be limited solely to these embodiments. The claims are to be construed literally, purposively, and / or to encompass equivalents.

[0131] REPRESENTATIVE FEATURES

[0132] Representative features are set out in the following clauses, which stand alone or may be combined, in any combination, with one or more features disclosed in the text and / or drawings of the specification.

[0133] 1 . An ostomy appliance, including a main body, which defines a waste collecting volume, including a stoma opening that provides an entrance to a collecting volume, and a main body connection formation, a cover, which is attachable to the main body via the main body connection and provides a cover layer for the main body, including: a lower cover connection formation located in a lower region, and an upper cover connection formation located in an upper region, and a flexible portion formed between the lower cover connection formation and the upper cover connection formation, for folding the cover during an attachment process in which the cover is attached to the main body.

[0134] 2. An ostomy appliance according to clause 1 wherein the flexible portion extends across the cover.

[0135] 3. An ostomy appliance according to clauses 1 or 2 wherein the lower cover connection formation defines at least a part of an edge of the flexible portion. 4. An ostomy appliance according to any one of the preceding clauses wherein the upper cover connection formation defines at least a part of an edge of the flexible portion.

[0136] 5. An ostomy appliance according to any one of the preceding clauses wherein the cover has a first and second side and the lower cover connection formation includes connection portions spaced apart on the second side of the cover, and I or wherein the upper cover connection formation includes connection portions spaced apart on the second side of the cover.

[0137] 6. An ostomy appliance according to clause 5 wherein the connection portions of the upper and I or lower cover connection formation are located on or adjacent a periphery of the cover.

[0138] 7. An ostomy appliance according to any one of the preceding clauses wherein the lower cover connection formation and I or the upper cover connection formation include hook-and-loop type connection portion(s).

[0139] 8. An ostomy appliance according to any one of the preceding clauses wherein the main body has a first side and a second side and the main body connection formation includes first and second connection portions spaced apart on the first side.

[0140] 9. An ostomy appliance according to clause 8 wherein each of the connection portions extends from a bottom of the first side to a top of the first side.

[0141] 10. An ostomy appliance according to any of the preceding clauses wherein the main body further includes a receiving formation and the cover further includes a projection formation, and the projection formation is configured to be received by the receiving formation when the cover is attached to the main body.

[0142] 11. An ostomy appliance according to clause 9 wherein the receiving formation forms a pocket and the projection formation is attached to the cover and extends to a free end, which is insertable in the pocket.

[0143] 12. An ostomy appliance according to clauses 9 or 10 wherein the projection formation attaches to the cover adjacent to the flexible portion.

[0144] 13. An ostomy appliance according to any one of the preceding clauses wherein the lower cover connection formation includes two connection portions, spaced apart on a side of the cover.

[0145] 14. An ostomy appliance, including a main body, which defines a waste collecting volume, and has a stoma opening that provides an entrance to the collecting volume, and a cover, which provides a cover layer for the main body, and is connected to the main body by a frangible connection. 15. An ostomy appliance according to clause 14, wherein the main body is formed from a first wall and a second wall which are attached about their peripheries.

[0146] 16. An ostomy appliance according to clause 15 wherein the frangible connection extends around a part of the periphery of the cover and main body.

[0147] 17. An ostomy appliance according to clause 15, wherein at least one portion of contact material is attached to the first wall, and optionally, wherein the contact material is or includes at least one of: a non-woven material, nylon, and a hook or loop fastener material.

[0148] 18. An ostomy appliance according to clause 17, wherein the contact material is located on and I or adjacent the periphery of the first wall.

[0149] 19. An ostomy appliance according to clause 17 or 18, wherein the contact material has a higher melting temperature than the first and second wall.

[0150] 20. An ostomy appliance according to any one of the preceding clauses 14 to 19, wherein the cover is formed of or includes a material which has a higher melting temperature than the first and second walls.

[0151] 21 . An ostomy appliance according to clause 20, wherein the cover is formed from a nonwoven material, and optionally, is embossed.

[0152] 22. An ostomy appliance according to any one of the preceding clauses wherein the cover is unconnected to the main body in an upper region, so that the unconnected portion of the cover can be selectively moved to inspect inside the collecting volume.

[0153] 23. An ostomy appliance according to clause 22 wherein the unconnected portion of the cover includes a hook-and-loop fastener to hold the cover over the upper region of the main body.

[0154] 24. An ostomy appliance according to any one of the preceding clauses 14 to 23 further including an outlet which provides an exit for waste from the waste collecting volume.

[0155] 25. An ostomy appliance according to any one of the preceding clauses 14 to 24 wherein a second cover is attachable to the main body of the appliance after the frangible connection between the main body and the cover is broken. 26. An ostomy appliance according to clause 25, wherein at least one portion of contact material is attached to the second wall and forms a main body connection formation for attaching the second cover to the main body.

[0156] 27. A method of manufacturing an ostomy appliance, the method including the steps of: providing a main body, which provides a waste collecting volume, and has a stoma opening that provides an entrance to the collecting volume, providing a cover, and forming a frangible connection between the cover and the main body.

[0157] 28. A method of manufacturing an ostomy appliance according to clause 27 wherein: forming a frangible connection includes welding the main body to the cover, and optionally, wherein welding includes an RF welding process.

[0158] 29. A method of manufacturing an ostomy appliance according to clauses 27 or 28 further including the step of: cutting around the outside of the frangible connection, and optionally, wherein the cutting step occurs simultaneously with forming the frangible connection.

[0159] 30. A method of manufacturing an ostomy appliance according to any one of clauses 27 to 29 wherein: providing a main body includes positioning a first layer of main body material on top of a second layer of main body material.

[0160] 31 . A method of manufacturing an ostomy appliance according to clause 30 wherein: providing a cover includes positioning a cover layer on top of the first layer.

[0161] 32. A method of manufacturing an ostomy appliance according to clauses 30 or 31 wherein: providing a main body includes preparing the first layer by attaching a contact material with a higher melting point than the first layer to the first layer in the region of the frangible connection.

[0162] 33. A method of manufacturing an ostomy appliance according to clause 32 wherein: attaching the contact material includes bonding to a surface of the first layer.

[0163] 34. A method of manufacturing an ostomy appliance according to any one of clauses 32 or 33 wherein the contact material is or includes at least one of: a non-woven material, nylon, and hook or loop material.

[0164] 35. A method of manufacturing an ostomy appliance according to any one of claims 31 to 34 further including: inserting a barrier layer between a portion of the first layer and a portion of the cover layer, which prevents a connection between the main body and the cover.

[0165] 36. A method of manufacturing an ostomy appliance according to any one of claims 31 to 35 wherein the cover layer is a non-woven material.

[0166] 37. An ostomy appliance according to any one of clauses 14 to 27 manufactured using the method of any of claims 28 to 26

[0167] 38. An ostomy appliance according to any one of clauses 14 to 27 in which the main body is constructed to form the main body of any one of clauses 1 to 14.

Claims

CLAIMS1 . An ostomy appliance, including a main body, which defines a waste collecting volume, and has a stoma opening that provides an entrance to the collecting volume, and a cover, which provides a cover layer for the main body, and is connected to the main body by a frangible connection.

2. An ostomy appliance according to claim 1 , wherein the main body is formed from a first wall and a second wall which are attached about their peripheries.

3. An ostomy appliance according to claim 2 wherein the frangible connection extends around a part of the periphery of the cover and main body.

4. An ostomy appliance according to claim 3, wherein at least one portion of contact material is attached to the first wall, and optionally, wherein the contact material is or includes at least one of: a non-woven material, nylon, and a hook or loop fastener material.

5. An ostomy appliance according to claim 4, wherein the contact material is located on and I or adjacent the periphery of the first wall.

6. An ostomy appliance according to claim 4 or 5, wherein the contact material has a higher melting temperature than the first and second wall.

7. An ostomy appliance according to any one of the preceding claims, wherein the cover is formed of or includes a material which has a higher melting temperature than the first and second walls.

8. An ostomy appliance according to claim 7, wherein the cover is formed from a non-woven material, and optionally, is embossed.

9. An ostomy appliance according to any one of the preceding claims wherein the cover is unconnected to the main body in an upper region, so that the unconnected portion of the cover can be selectively moved to inspect inside the collecting volume.

10. An ostomy appliance according to claim 9 wherein the unconnected portion of the cover includes a hook-and-loop fastener to hold the cover over the upper region of the main body.11 . An ostomy appliance according to any one of the preceding claims further including an outlet which provides an exit for waste from the waste collecting volume.

12. An ostomy appliance according to any one of the preceding claims wherein a second cover is attachable to the main body of the appliance after the frangible connection between the main body and the cover is broken.

13. An ostomy appliance according to claim 12, wherein at least one portion of contact material is attached to the second wall and forms a main body connection formation for attaching the second cover to the main body.

14. A method of manufacturing an ostomy appliance, the method including the steps of: providing a main body, which provides a waste collecting volume, and has a stoma opening that provides an entrance to the collecting volume, providing a cover, and forming a frangible connection between the cover and the main body.

15. A method of manufacturing an ostomy appliance according to claim 14 wherein: forming a frangible connection includes welding the main body to the cover, and optionally, wherein welding includes an RF welding process.

16. A method of manufacturing an ostomy appliance according to claims 14 or 15 further including the step of: cutting around the outside of the frangible connection, and optionally, wherein the cutting step occurs simultaneously with forming the frangible connection.

17. A method of manufacturing an ostomy appliance according to any one of claims 14 to 16 wherein: providing a main body includes positioning a first layer of main body material on top of a second layer of main body material.

18. A method of manufacturing an ostomy appliance according to claim 17 wherein: providing a cover includes positioning a cover layer on top of the first layer.

19. A method of manufacturing an ostomy appliance according to claims 17 or 18 wherein:providing a main body includes preparing the first layer by attaching a contact material with a higher melting point than the first layer to the first layer in the region of the frangible connection.

20. A method of manufacturing an ostomy appliance according to claim 19 wherein: attaching the contact material includes bonding to a surface of the first layer.

21. A method of manufacturing an ostomy appliance according to any one of claims 19 or 20 wherein the contact material is or includes at least one of: a non-woven material, nylon, and hook or loop material.

22. A method of manufacturing an ostomy appliance according to any one of claims 18 to 21 further including: inserting a barrier layer between a portion of the first layer and a portion of the cover layer, which prevents a connection between the main body and the cover.

23. A method of manufacturing an ostomy appliance according to any one of claims 18 to 22 wherein the cover layer is a non-woven material.

24. An ostomy appliance according to any one of claims 1 to 13 manufactured using the method of any of claims 14 to 23.