GB2624422A

GB2624422A - An ostomy appliance

Info

Publication number: GB2624422A
Application number: GB2217201.9A
Authority: GB
Inventors: Smith Lee; Howard Lee
Original assignee: Salts Healthcare Ltd
Current assignee: Salts Healthcare Ltd
Priority date: 2022-11-17
Filing date: 2022-11-17
Publication date: 2024-05-22
Also published as: WO2024105397A1; GB202217201D0

Abstract

An ostomy bag (10, Fig 1) comprising a valve 100 having a body 110 connected to a first and/or second wall 12, 14 of the bag, an inlet and an outlet connected by a flow path, and a closure arrangement 120, such as a bung, which is moveable between a closed position, in which the closure arrangement blocks the outlet, and an open position in which the outlet is open. A flow control mechanism is also provided, the flow control mechanism including a distribution member 300 attached to one of the first and second walls of the bag, and a contact surface 320 provided between the first and second walls of the bag, the distribution member 300 being deflectable towards the contact surface 320 to move the flow control mechanism towards a closed condition, where flow of liquid from the valve outlet is prevented or inhibited. The valve is also claimed in isolation.

Description

Title: An ostomy appliance FIELD

Embodiments of the invention relate to an ostomy appliance.

BACKGROUND

Ostomy appliances are well known in the field. They are typically attached to a user via an adhesive member that extends around the user's stoma with adhesive and provide a collecting volume to collect waste exiting the stoma. A mechanism for draining the collecting volume is often provided -typically, these are in the form of a tap, so that a user can empty waste that is collected in the collecting volume without having to remove and dispose of the entire appliance.

Embodiments of the present invention seek to alleviate one or more problems or issues associated

with the prior art.

BRIEF DESCRIPTION OF THE INVENTION

According to a first aspect of the invention we provide an ostomy appliance including: a first wall and a second wall which are connected about their respective peripheries to form an internal collection volume, the first wall includes an opening for receiving a stoma, a valve having: a body connected to the first and / or the second wall, an inlet and an outlet, connected by a flow path, a closure arrangement which is moveable between a closed position, in which the closure arrangement blocks the outlet, such that liquid is substantially prevented from flowing through the outlet, and an open position in which the outlet is open, such that liquid is permitted to flow out of the outlet, and a flow control mechanism which is configured to have an open condition and a closed 30 condition in which the flow of liquid from the outlet is substantially prevent or inhibited, the flow control mechanism including: a distribution member attached to one of the first and second walls, and a contact surface provided between the first and second walls, and configured such that the distribution member is deflectable towards the contact surface when the flow control mechanism is moved towards its closed condition.

The distribution member may extend across a majority of the body of the valve. The body may include a first and a second attachment portion, each of which may provide attachment surfaces for the first and second walls, and the distribution member may extend from the first attachment portion to the second attachment portion.

The distribution member may be connected to the first or second wall in a first zone on one side and connected to the same first or second wall in a second zone on a second side, which may be spaced from the first zone. The distribution member may be formed from a relatively less flexible material than the first and / or second wall.

The distribution member may include a deflection aid. The deflection aid may include at least one of a crease, perforation, score line or area of weakness that encourages the distribution member to deflect in a consistent manner each time the flow control mechanism is used. The deflection aid may extend in a curved shape across the distribution member.

An area of the distribution member to one side of the curved shape may provide a convex portion.

Optionally, the side may be further from the outlet than the remainder of the distribution member.

A deformable layer may be attached to the distribution member. Optionally, the deformable layer may be a foam material. The deformable layer may be adjacent the first or second wall.

The flow control mechanism may be biased its open condition.

The distribution member may have a snapping point at which it will accelerate back to an / its original form. The distribution member and the contact surface may be aligned, so that when the distribution member is deflected by a deflecting force, the distribution member coordinates! corresponds with a profile of the contact surface.

The profile of the contact surface may include a concave portion.

The appliance may include a further layer over one or both of the first and second walls.

The first or the second wall may include a storage portion which receives the valve in a stored position and holds the valve in position. The closure arrangement may include a bung portion that closes the outlet of the valve via frictional engagement.

According to a second aspect of the invention we provide a valve for an ostomy appliance which includes the features of the valve as claimed in in relation to the first aspect of the invention.

BRIEF DESCRIPTION OF THE FIGURES

In order that the 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: FIGURE 1 is a schematic view of an ostomy appliance; FIGURE 2 is a partial sectional schematic view of a valve of the ostomy appliance, FIGURE 3 is a blown out partial sectional perspective view of the valve; and FIGURE 4 is a partial sectional rear schematic view of the valve.

DETAILED DESCRIPTION OF THE DISCLOSURE

Referring to the figures, an ostomy appliance 10 (appliance 10) is illustrated. The ostomy appliance 10 includes a first wall 12 which has an attachment member (shown by a dashed line 11 in figure 1) for attaching the appliance 10 to a user and also defines a stoma receiving opening for fitting about the stoma of the user.

A second wall 14 is connected about its periphery to a periphery of the first wall 12, so that between the first and second wall 12, 14 forms a collecting volume (to receive waste from the stoma). Another layer (known as a comfort layer) may extend over one or both of the first and second walls 12, 14. This is generally a softer material to provide a comfortable outer surface for a user wearing the appliance 10.

The ostomy appliance 10 further includes an outlet portion 20. The outlet portion 20 could be formed from an extension / the same sheets as the first and second walls 12, 14 or from a first and a second outlet wall (the first and second outlet walls being connected along a periphery to form a tube / conduit) which connect to the first and second walls 12, 14 to form a continuous "side" of the appliance 10. The remainder of the description discusses the first and second walls 12, 14 primarily to indicate a side of the appliance 10 and not to exclude the possibility that the first wall 12 could be formed from multiple sheets of material connected together to form a single wall (likewise of the second wall 14).

The appliance 10 also includes a valve 100 which provides an outlet. The valve 100 is connected to the outlet portion 20. Thus, the outlet portion 20 and the valve 100 provide a flow path between the collecting volume and the outlet. In other words, the outlet portion 20 forms a conduit between the collecting volume and the valve 100. Waste flowing from the collecting volume will pass through the outlet portion 20 and through the valve 100 to exit the appliance 10 through the outlet.

The ostomy appliance 10 is specifically a urostomy or ileostomy appliance, which is configured to accommodate waste with a higher proportion of liquid than other ostomy appliances (e.g. a combination of urine, mucus, and potentially softer somewhat solid matter). Hence, the valve 100 must be able to prevent liquid from exiting the appliance 10 when it is in its closed position.

Likewise, any other flow control measures put in place for the user to alter the flow out of the appliance 10 must also be suitable for waste containing a high percentage of liquid (i.e. waste with a relatively low viscosity which means the waste can flow in a similar manner to water or other liquid).

The valve 100 includes a body 110, an inlet connecting to the outlet by a flow path (i.e. the flow path for waste out of the valve 100 and the appliance that the valve 100 is attached to), and a closure arrangement 120. The closure arrangement 120 is moveable between an open position and a closed position (and vice versa). In the closed position, the closure arrangement 120 blocks the outlet, such that liquid cannot flow through the outlet. In the open position, the outlet is open, such that liquid is permitted to flow out of the outlet.

The body 110 is configured to be connected to the ostomy appliance 10 (and may be attached to an outlet portion 20 as described above). In some embodiments, one or more external surfaces of the valve 100 cooperate with one or more external surfaces of the outlet portion 20 to form a smooth transition between the outlet portion 20 and the valve 100 (see for example, figure 3). In other words, the valve 100 is incorporated into the outlet portion 20 to form a tail arrangement. Such incorporation is more comfortable for a user to wear. For example, it may reduce sharp corners and pads of the appliance 10 from digging in to a user's flesh, etc. In some embodiments, the outlet portion 20 provides the upper and lower external surfaces (of the tail arrangement) and the valve 100 provides both left and right side external surfaces. In some embodiments, the valve is made of a soft and / or flexible material (e.g. to further increase the comfort of a user).

The body 110 includes a first attachment portion 200 and a second attachment portion 202. Each attachment portion 200, 202 extends away from the inlet. In other words, the valve 100 includes a pair of attachment portions 200, 202 which are elongate and project away from the body 110 of the valve 100. In a top down or bottom up view of the valve 100, the attachment portions 200, 202 extend away from the body 110, so that the overall valve shape is generally U or V shaped (i.e. each attachment portion 200, 202 forms a limb).

The first and second attachment portions 200, 202 provide one or more attachment surfaces for connection to the first and second wall 12, 14. In the illustrated examples, the attachment portions 200,202 provide first and second attachment surfaces. The first attachment surface lies substantially in a first plane and the second attachment surface lies substantially in a second plane. The first plane and the second plane are inclined with respect to each other. In the present example, the first attachment surface forms an external surface of the body 110 and the second attachment surface forms another external surface of the body 110 (e.g. on opposing sides of the valve 100). In other words, the first attachment surface forms an upper surface of the valve 100 and the second attachment surface forms a lower surface of the valve 100.

In this example, the inlet and outlet and the flow path extending between them extends through a generally central portion of the body 110. Thus, the generally central portion of the body extends between the first and second attachment surfaces.

In some embodiments, the first and or the second attachment portions 200, 202 taper (i.e. get progressively narrower) as they extend away from the central portion of the body of the valve 100. In other words, the first and second attachment portions 200, 202 each form a general wedge shape when viewed side on.

Thus, the tail arrangement includes the outlet portion 20 and the valve 100. Internally, the passage for waste (between the appliance 10 storage volume and the outlet) is formed from (a bottom part of the first and second walls) and the first and second attachment portions 200, 202 of the valve 100.

In some examples, the closure arrangement 120 is detachably connectable to the body 110. In other words, the closure arrangement 120 is removable from the body 110 of the valve 100 and re-attachable as desired. Thus, the closure arrangement 120 may be attached to and supported by the body 110 irrespective of whether the valve 100 is open or closed.

In some embodiments, the closure arrangement 120 includes a connection member 122 that provides the detachable connection to the body 110. In the illustrated example, the closure arrangement 120 includes a closure body and the connection member 122. In some embodiments, the connection member 122 includes an elongate portion that extends away from the closure body (and that provides the connection to the body 110). Thus, the connection member 122 provides a projection that can be attached to the body 110 of the valve 100. The body 110 of the valve 100 includes an opening / recess that receives the projection and holds the connection member 122 / closure body to the body 110 of the valve 100.

The closure body supports a bung portion 130 that is configured to be positioned in the outlet when the closure arrangement 120 is in its closed position (i.e. blocking waste from exiting the valve 100). Thus, the bung portion 130 is held in the outlet by a friction or push fit. The closure body (and more specifically, the bung portion 130) is configured to be insertable into the outlet of the valve 100 whether the connection member 122 is attached to the body 110 or not.

In use, the valve 100 is opened by moving the closure arrangement 120 to its open position. Essentially, this must involve unblocking the outlet. Thus, the closure body is moved out of contact with the outlet. In addition, the closure arrangement 120 may be detached from the body 110 of the valve 100 if desired. In some embodiments, the ability to rotate the closure arrangement 120 may also be provided, as discussed above.

The ostomy appliance 10 also includes a flow control mechanism. The flow control mechanism allows a user to close the flow path between the main volume of the appliance 10 and the outlet by using their hand even if the bung portion 120 has already been removed from the valve 100.

The flow control mechanism includes a distribution member 300 and a contact surface 320. The distribution member 300 is attached to one of the first and second walls 12, 14 On the illustrated example, the distribution member 300 is attached to the second wall 14 but the flow control mechanism could be formed to operate on either side so the wall is not specified below). It should be appreciated that it may be advantageous to locate the distribution member 300 on the outer face of the appliance 10 / facing away from a user (e.g. as illustrated, on the second wall 14) to improve usability.

The contact surface 320 is provided between the first and second walls 12, 14. The distribution member 300 is deflectable towards the contact surface 320 in order to close the flow control mechanism.

In embodiments, the distribution member 300 extends across a majority of the body 110 of the valve 100 (i.e. extends across 70% or more of the width of the tall arrangement). In preferred embodiments, the distribution member 300 may extend across around 85 to 95% of the width of the outlet portion 20 (and may be between 90 and 95% of the width in preferred embodiments -this ensures that the distribution member 300 does not extend outwards of the tail arrangement and improves usability).

In embodiments, the distribution member 300 extends from the first attachment portion 200 to the second attachment portion 202. In other words, the distribution member 300 overlies the first / second wall 12, 14. It also overlies the valve 100 (i.e. part of the first! second attachment portions 200, 202). A first end 300a attaches (in a first zone) to the first / second wall 12, 14 over the first limb 200 of the valve 100 and a second end 300b attaches (in a second zone) to the same first! second wall 12, 14 over the second limb 202 of the valve 100. The first and second "attachment" zones are spaced from each other (in this case across the outlet portion 20).

In some embodiments, the distribution member includes a deflection aid 302. The deflection aid 302 may be provided by one or more of the following features: a crease line, a perforation (or perforated line), a score line, and an area of weakness. The deflection aid 302 is provided to encourage the distribution member 300 to deflect in a consistent manner each time the flow control mechanism is used.

In some embodiments, the deflection aid 302 is a raised portion of the distribution member 300. The raised portion may be located generally centrally in the distribution member 300. In other words, the deflection aid 302 may be formed by a generally central ridge (a curved ridge is illustrated in figure 2). It should be appreciated that the deflection functionality could be provided by a number of formations, e.g. a raised point, and what is important is a raised zone or portion that is deflectable inwards.

In some embodiments, the deflection aid is formed by forming a score line (i.e. with a blade or sharp instrument) and edges of the distribution member 300 are pushed towards each other. This forms the raised ridge profile required. It may be possible to form the raised profile through a heating process in which the distribution member 30 is heated (to a malleable! relatively soft state) and then pushed onto a shaped profile to provide the required raised portion / profile.

In some embodiments (see figures 2 and 3, for example), the deflection aid 302 extends in a curved shape across the deflection member 300. A first end of the deflection aid 302 is at or adjacent a top edge of the distribution member 300 (and aligns with an edge of the first attachment portion 200 and, in this example, is at or next to first end 300a) and the second (opposing) end is at or adjacent the top edge on the opposing side of the distribution member 300 (and aligns with an edge of the second attachment portion 202 and, in this example, is at or adjacent second end 300b).

An area of the distribution member 300 above the deflection aid 302 forms a concave portion. In other words, the area defined between the deflection aid 302 and an edge of the distribution member (forming a crescent or circular segment section) is dished inwards towards the first / second wall 12, 14. The remainder of the distribution member 300 (which, in this example, is a bottom portion when the appliance is in use) is relatively more planar / flat. While a crescent shape may be preferred, it should be appreciated that the score line could be many different shapes -for example, a straight ridge, a chevron or V-shape, a partial rectangular shape, etc. It should be appreciated that the deflection aid 302 may include one or more formations such as the score line or perforation to form a raised profile. A pair of crescents could be formed that extend in opposition direction to each other.

In some embodiments, the flow control mechanism is biased to its open condition. In other words, when there is no deflection force exerted on the distribution member 300, it maintains its default / original shape and the flow path remains open. Further, if the deflection force is removed (i.e. the flow control mechanism was previously in its closed condition), the distribution member 300 will automatically move outwards / away from the contact surface 320.

In the present example, the deflection aid 302 assists in ensuring the distribution member 300 acts as expected. The distribution member 300 has a snapping point at which it will accelerate back to its original form. This is provided by the deflection aid 302 which allows the distribution member 300 to "pop" outwards.

In some embodiments, an additional deformable layer 304 is attached to the distribution member 300. The deformable layer 304 may be a foam or other deformable material. In the present example, the deformable layer 304 is positioned adjacent to the first / second wall 12, 14. The layer of foam is adjacent the first or second wall 12, 14. In other words, the distribution member 300 forms a first layer 301 and the additional deformable layer 304 extends across a central section and is attached to the first layer 301 (between the first layer 301 and the wall 12, 14).

The contact surface 320 is part of the valve 100 and is located upstream of the outlet (i.e. the contact surface 320 is located between the internal collecting volume of the appliance 10 and the outlet of the valve 100). In the present example, the contact surface 320 extends generally transversely across the valve 100 and the outlet portion 20 (i.e. from one attachment portion 200 of the body 110 to the second attachment portion 202). Thus, the contact surface 320 extends across the space formed between the limbs of the body 110.

In this example, the contact surface 320 includes a concave portion (preferably a centre portion of the concave profile is generally central with respect to the contact surface 320 and the remainder of the valve 100).

In the illustrated embodiment, the distribution member 300 and the contact surface 320 are generally aligned. Thus, when the distribution member 300 is deflected by a deflecting force, the distribution member 300 coordinates / corresponds with a profile of the contact surface 320.

In some embodiments, the distribution member 300 / first layer 301 is formed from a relatively less flexible material than the first and / or second wall 12, 14. Additionally or alternatively, the layer 301 is thicker, so it may also act like a less flexible material simply because it is a thicker layer than the film. In some embodiments, the layer 301 is made of polyester and may be around 125 microns thick.

As mentioned above, the flow control mechanism is for a user to manually shut the exit of the appliance 10 even if the closure arrangement 120 is open. A compressive / deflection force is applied to the distribution member 300 towards the appliance 10 / contact surface 320 (the mechanism is designed to work with a finger or thumb providing this force). Under the compression the distribution member 300 pinches the first / second wall 12, 14 against the contact surface 320 to prevent contents inside passing through the pinch point. The distribution member 300 provides a relatively more even force across the width of the contact surface / flow path than if the wall 12, 14 was pressed alone.

Thus, the manual sealing action is improved and the user can be more confident about using the feature on their appliance 10 as necessary.

When the user removes their thumb! finger (i.e. the force is removed) the distribution member 300 moves outwards (away from the contact surface 320) and the contents upstream of the pinch point is able to flow towards the outlet.

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.

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

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.

Claims

CLAIMS1. An ostomy appliance including: a first wall and a second wall which are connected about their respective peripheries to form an internal collection volume, the first wall includes an opening for receiving a stoma, a valve having: a body connected to the first and / or the second wall, an inlet and an outlet, connected by a flow path, a closure arrangement which is moveable between a closed position, in which the closure arrangement blocks the outlet, such that liquid is substantially prevented from flowing through the outlet, and an open position in which the outlet is open, such that liquid is permitted to flow out of the outlet, and a flow control mechanism which is configured to have an open condition and a closed condition in which the flow of liquid from the outlet is substantially prevent or inhibited, the flow control mechanism including: a distribution member attached to one of the first and second walls, and a contact surface provided between the first and second walls, and configured such that the distribution member is deflectable towards the contact surface when the flow control mechanism is moved towards its closed condition.
2. An ostomy appliance according to claim 1 wherein the distribution member extends across a majority of the body of the valve.
3. An ostomy appliance according to claim 1 or 2 wherein the body includes a first and a second attachment portion, each of which provide attachment surfaces for the first and second walls, and the distribution member extends from the first attachment portion to the second attachment portion.
4. An ostomy appliance according to any of the preceding claims wherein the distribution member is connected to the first or second wall in a first zone on one side and connected to the same first or second wall in a second zone on a second side, which is spaced from the first zone.
5. An ostomy appliance according to any one of the preceding claims wherein the distribution member is formed from a relatively less flexible material than the first and / or second wall.
6. An ostomy appliance according to any one of the preceding claims wherein the distribution member includes a deflection aid which includes at least one of a crease, perforation, score line or area of weakness that encourages the distribution member to deflect in a consistent manner each time the flow control mechanism is used.
7. An ostomy appliance according to the claim 7 wherein the deflection aid extends in a curved shape across the distribution member.
8. An ostomy appliance according to claim 8 wherein an area of the distribution member to one side of the curved shape provides a convex portion and optionally, the side is further from the outlet than the remainder of the distribution member.
9. An ostomy appliance according to any one of the preceding claims wherein a deformable layer is attached to the distribution member and optionally, the deformable layer is a foam material.
10. An ostomy appliance according to claim 9 wherein the deformable layer is adjacent the first or second wall.
11. An ostomy appliance according to any one of the preceding claims wherein the flow control mechanism is biased its open condition.
12. An ostomy appliance according to claim 11 when further dependent on any of claims 6 to 9 wherein the distribution member has a snapping point at which it will accelerate back to its original form.
13. An ostomy appliance according to any one of the preceding claims wherein the distribution member and the contact surface are aligned, so that when the distribution member is deflected by a deflecting force, the distribution member coordinates / corresponds with a profile of the contact surface.
14. An ostomy appliance according to claim 13 wherein the profile of the contact surface includes a concave portion.
15. An ostomy appliance according to any of the preceding claims wherein the appliance includes a further layer over one or both of the first and second walls.
16. An ostomy appliance according to any of the preceding claims wherein the first or the second wall includes a storage portion which receives the valve in a stored position and holds the valve in position.
17. An ostomy appliance according to any one of the preceding claims wherein the closure arrangement includes a bung portion that closes the outlet of the valve via frictional engagement.
18. A valve for an ostomy appliance which includes the features of the valve as claimed in any of claims 1 to 17.