Patent Description:
An ostomy appliance may be provided with an outlet valve for draining liquid from the bag of the ostomy appliance, either for direct disposal of the liquid or via an additional appliance such as a drain bag which may be attached to the outlet valve in use. There are many forms of ostomy appliance which try to provide an easily drainable appliance.

<CIT> is considered to represent the prior art closest to the subject-matter of claim <NUM> and discloses an outlet valve consisting of a base member and at least one movable means which together form a discharge tube or hose member, a stop valve and a closing valve, said movable means being rotatably and/or linearly displaceable and by means of which the valve system can be set in three positions, a first position in which both the tetr stop valve and the closing valve are open, a second position in which the stop valve is closed and the closing valve is open, and a third position in which both valves are closed. A collection bag provided with an outlet valve as stated above.

<CIT> discloses a drain assembly for a urostomy pouch or other similar collection device for permitting continuous overnight draining of the pouch into a suitable receptacle. The assembly includes a body member adapted to be secured to a pouch at the lower end thereof and defining a path for the outflow of the fluid contents of the pouch, a rotary valve member for selectively opening and closing the flow passage, and a drainage tube equipped with a coupler for releasably engaging a stem portion of the valve member. <CIT> discloses a drainage valve for a liquid container such as a body fluid drainage bag, the valve comprising an inlet and an outlet member which respectively define a first and second open passage. The outlet member is rotatably mounted to the inlet member for rotation between an open position in which the first and second passages are connected and a closed position where they are disconnected.

<CIT> discloses a valve for a pouch comprising a valve body and a valve stem. The valve stem is received in the valve body and is rotatable between an open and a closed position. The valve stem may also include a grasping portion to assist rotation of the valve stem.

<CIT> discloses a valve for a drainage bag comprising a valve body and an outlet element that can be rotated in the valve body between an open and closed condition. The valve body is sized such that it can be welded to the drainage bag with the outlet element already positioned in the valve body.

<CIT> discloses a system and method for emptying an ostomy bag into a collecting bag via first and second connectors. The user may lock the ostomy bag to the collecting bag and open valves in the connectors in single manoeuvre and also unlock the bags and close the valves in a single manoeuvre.

<CIT> discloses a valve comprising first and second tubes located about a common axis. Each tube has a portion of its wall cut-away and one tube is rotatable with respect to the other between an open position where the cut-away portions overlap and a closed position where the cut-away portions do not.

There remains a need for ostomy appliances with enhanced usability for ostomates, particularly in the area of ease of use, particularly when connecting the outlet valve to an additional appliance, for example a drain bag.

In this specification, the term "stomal output" refers to any gases or fluids or solids produced by an ostomate that may be secreted from the stoma or that exit the stoma.

In this specification, the term "stoma" refers to an opening in the body. Generally, the stoma is a surgical opening in the torso of the body. In some instances, the term "stoma" also refers to internal tissue, organs or portions thereof that are exposed by the opening. By way of non-limiting example, internal tissue may be selected from colon, ileum, small intestine, large intestine, jejunum, and duodenum, and combinations thereof. The internal tissue may be an end or a loop of a small or large intestine.

In this specification, the term "ostomate" refers to a subject that may have use of the ostomy appliance disclosed herein. While ostomate usually refers to a subject with a surgical opening, as used herein, "ostomate" may refer to a subject who has a stoma, regardless of whether the stoma was created by surgery or other means.

The term "user" may refer to an ostomate, or to another person assisting the ostomate, for example, with emptying of the stomal output from the cavity.

In this specification, the ostomy appliances disclosed herein may, for example, be used for managing a stoma created by an esophagostomy, a gastrostomy, a cholecystostomy, a choledochostomy, a cecostomy, a colostomy, a duodenostomy, an ileostomy, a jejunostomy, an appendicostomy, a tracheostomy, a urostomy, a nephrostomy, an ureterostomy, or a vesicostomy. The ostomy appliances disclosed herein may be used with additional devices including, but not limited to, a shunt, a catheter, a plug or a fecal management system.

Beneficially, the ostomy appliances of the present disclosure may permit an ostomate to increase the period of use of each ostomy appliance compared to prior art appliances. This may be achieved by providing means for draining the cavity of stomal output reliably and hygienically so as to increase an ostomate's confidence in reusing the ostomy appliance compared to some prior art appliances. Since the ostomate may be inclined to use each ostomy appliance of the present disclosure for longer, the total number of ostomy appliances used by the ostomate in a given time period may be reduced. This may produce an environmental benefit in reducing the amount of environmental waste produced.

In this specification locations and orientations of features may be described with reference to the ostomy appliance being "in use", "orientated as it would be in use" or similar. Such terms refer to the intended orientation of the ostomy appliance when it is adhered to a body of an ostomate with the ostomate in a standing position, irrespective of whether the ostomy appliance is currently performing such a use or the actual position of the ostomate. The terms "upper" and "lower" and related terms refer to the relative position of a part or portion of the ostomy appliance when orientated as it would be in use. For example, an apex of the ostomy appliance may be referred to as an "lower" apex in use of the ostomy appliance. In such an example, said apex will be intended to be the lowermost apex (in the vertical direction) of the ostomy appliance when attached to the body of a standing ostomate. However, the reader skilled in the art will appreciate that before attachment to the ostomate said apex may not always be the lowermost apex and in addition when attached the apex may not always be the lowermost apex if the ostomate adopts a non-standing position, for example lying down.

In this specification the term "front" refers to the relative position of a part or portion of the ostomy appliance with reference to the body of an ostomate when the ostomy appliance is attached to the body. "Front" refers to a position relatively further away from the body of the ostomate than a comparative position that is relatively closer to the body. Similarly, "back" refers to a position relatively closer to the body of the ostomate than a comparative position that is "front".

In this specification, the terms "inner" and "outer" with reference to parts of the outlet valve refer to the relative position of a part or portion of the ostomy appliance with reference to the axis of rotation of the outlet element, a relatively "inner" part being closer to the axis of rotation than a relatively "outer" part.

In this specification, the term "affixed" is used to refer to a connection in which teh component in question cannot be removed during normal use of the outlet valve or without damaging the component.

The present disclosure provides an outlet valve for an ostomy appliance according to claim <NUM>.

The cap may comprise an inner cap end portion arranged to overlie the axle end wall and the inner cap end portion may comprise an intake opening being arranged to be rotatable into a position in which the intake opening at least partially aligns with the valve opening such that the outlet element is in the open configuration, wherein, the intake opening may have an arcuate shape aligned with a circumference around the axis of rotation of the cap. Thus, the user is able to control the flow rate of fluid through the valve by rotating the cap, and the valve is also configurable so that multiple cap positions correspond to the open configuration.

The cap may comprise an inner cap end portion arranged to overlie the axle end wall and the inner cap end portion may comprise an intake opening being arranged to be rotatable into a position in which the intake opening at least partially aligns with the valve opening such that the outlet element is in the open configuration, wherein a gasket seal may be arranged around a periphery of the valve opening to seal between the axle end wall and a portion of the cap around the periphery of the valve opening, and wherein the intake opening may comprise a protrusion provided across at least a part of the intake opening. Thus, a protrusion is provided across the intake opening to ensure the gasket seal is retained in place as the intake opening moves with respect to the gasket seal.

The protrusion may be configured to at least partially compress the gasket seal while the gasket seal is adjacent to the intake opening. Thus, the gasket seal is held securely against the axle end wall.

An outer surface of the curved lateral wall may comprise a circumferential protrusion around a circumference of the axle, and the cap may comprise a retaining tooth configured to engage with the circumferential protrusion to prevent axial movement of the cap relative to the axle during rotation. Thus, the cap is retained on the axle which ensures a good seal is maintained and leakage is minimised, without requiring retaining teeth around the whole circumference of the cap.

The retaining tooth may be provided adjacent to the outlet tube. Thus, the tooth is placed in a convenient place to allow the tube to be used to snap-fit the cap to the axle.

The cap may comprise an inner wall arranged concentrically around the curved lateral wall of the axle, and an outer wall arranged concentrically around the inner wall such that a flow space is defined between the inner wall and the outer wall, the flow space being in liquid communication with the outlet tube.

The axle may be arranged on a valve base for attachment to an outer face of the ostomy appliance, and protrudes from the valve base away from the outer face of ostomy appliance in use.

Additionally, or alternatively, the axle end wall may generally planar.

Additionally, a gasket seal may be arranged around a periphery of the valve opening to seal between the axle end wall and a portion of the cap around the periphery of the valve opening.

Additionally, the cap may comprise an inner wall, the inner wall comprising:.

A gasket seal may be arranged on the axle end wall around a periphery of the valve opening to seal between the axle end wall and a planar face of the inner cap end portion.

An intake opening may be provided in the inner cap end portion, the intake opening being arranged to be rotatable into a position in which the intake opening at least partially aligns with the valve opening, such that the outlet element is in the open configuration. The outlet element may be rotatable from a fully open position in which the intake opening is fully aligned with the valve opening to a fully closed position in which the valve opening is obstructed by the inner cap end portion such that no liquid may pass from the hollow bore of the axle to the flow space through the valve opening. The inner cap end portion may be generally planar. The cap may further comprise an outer wall arranged concentrically around the inner wall such that a flow space is defined between the inner wall and the outer wall, the flow space being in liquid communication with the outlet tube. The outer wall may comprise an outer side wall portion and an outer cap end portion, wherein the outer cap end portion overlies the inner cap end portion and is axially spaced from the inner cap end portion such that at least a portion of the flow space is arranged between the outer cap end portion and the inner cap end portion.

Additionally, or alternatively, an axis of rotation of the outlet element defined by the axle may be perpendicular to the elongate axis of the outlet tube and optionally wherein the axis of rotation is perpendicular to the body of the ostomate in use. The axle end wall may be arranged transverse to the axis of rotation, and optionally perpendicular to the axis of rotation defined by the axle.

The present disclosure also provides an ostomy appliance comprising:.

wherein the outlet valve is attached to an outer face of the ostomy bag. In the closed configuration the outlet element substantially may overlie a cavity of the ostomy bag; and in the open configuration at least a portion of the outlet element may extend across a lower edge of the cavity of the ostomy bag.

Aspects of the present disclosure provide for an outlet valve for an ostomy appliance comprising: an axle defining a hollow bore for receiving a liquid output from the ostomy appliance, the axle comprising a curved lateral wall; and an outlet element comprising a cap arranged concentrically with the axle and an outlet tube affixed to the cap; wherein a valve opening is defined in the curved lateral wall; and the cap is rotatable around the axle to move from a closed configuration in which the valve opening is not in liquid communication with the outlet tube to an open configuration in which the valve opening is in liquid communication with the outlet tube; wherein the outlet valve further comprises at least one seal configured to provide sealing between the cap and the axle around a circumference of the axle and sealing between the intake opening and the valve opening when the outlet element is in the closed configuration.

The valve is thus less prone to leaks as sealing is provided both around a circumference of the axle, preventing leakage between the axle and cap, and also between the valve opening and intake opening when the outlet element is in the closed configuration, preventing leakage from the valve opening to the intake opening when the valve is closed.

The at least one seal comprises a continuous first seal configured to provide sealing between the cap and the axle around a circumference of the axle and wherein the distance between the first seal and a basal end of the axle varies around the circumference of the axle. Thus, as the distance between the first seal and basal end of the axle varies around the circumference of the axle, the first seal may be arranged to provide sealing between the intake opening and the valve opening when the outlet element is in the closed configuration.

In some embodiments, the at least one seal comprises a first seal configured to provide sealing around a perimeter of the intake opening when the outlet element is in the closed position, the first seal being integrally formed with a second seal configured to provide sealing between the cap and the axle around a circumference of the axle.

A first seal may be configured to provide sealing between the cap and the axle around a perimeter of the intake opening when the outlet element is in the closed configuration, the first seal may be integrally formed with a second seal configured to provide sealing between the cap and the axle around a circumference of the axle.

As described above, the seal provides sealing between the intake opening and valve opening when the outlet element is in the closed configuration. Accordingly, in some embodiments there is provided an outlet valve for an ostomy appliance comprising: an axle defining a hollow bore for receiving a liquid output from the ostomy appliance, the axle comprising a curved lateral wall; and an outlet element comprising a cap arranged concentrically with the axle and an outlet tube affixed to the cap; wherein a valve opening is defined in the curved lateral wall; and the cap is rotatable around the axle to move from a closed configuration in which the valve opening is not in liquid communication with the outlet tube to an open configuration in which the valve opening is in liquid communication with the outlet tube; wherein the outlet valve further comprises at least one seal configured to provide sealing between the cap and the axle around a circumference of the axle and sealing between the intake opening and the valve opening when the outlet element is in the closed configuration, wherein the at least one seal comprises a first seal configured to provide sealing around a perimeter of the intake opening when the outlet element is in the closed position, the first seal being integrally formed with a second seal configured to provide sealing between the cap and the axle around a circumference of the axle.

Additionally, or alternatively, the axle may comprise an axle end wall, wherein the axle end wall is optionally generally planar.

Additionally, or alternatively, the valve opening may be arranged in a curved lateral wall of the axle. The first seal may comprise a gasket seal arranged on the curved lateral wall of the axle, the first seal being spaced apart from the valve opening around the circumference of the axle. The gasket seal may have a profile corresponding to the shape of the intake opening. The outlet tube may be configured to rotate with the cap such that on rotation of the cap the intake opening of the outlet tube is moved between an open position in which the intake opening is in liquid communication with the valve opening and a closed position in which the intake opening is not in liquid connection with the valve opening. In the closed position the first seal may be aligned with and arranged around a periphery of the intake opening, thereby providing a seal between the intake opening and the curved lateral wall of the axle.

Additionally, or alternatively, the cap may comprise a curved cap wall defining a generally cylindrical cavity for receiving the axle such that the axle is rotatably arranged within the curved cap wall. The second seal may be arranged around the circumference of the axle between the curved cap wall and the axle, at an axial position between the intake opening and a distal end of the curved cap wall.

Additionally, or alternatively, the axle may be arranged on a valve base for attachment to an outer face of the ostomy appliance, and may protrude from the valve base away from the outer face of ostomy appliance in use.

Additionally, or alternatively, a third, circumferential seal may be arranged between the valve base and the cap at an axial position between a proximal end of the cap and the valve opening.

Additionally, or alternatively, an axis of rotation of the outlet element defined by the axle may be perpendicular to the elongate axis of the outlet tube and optionally the axis of rotation may be perpendicular to the body of the ostomate in use.

According to the further aspect, the present disclosure also provides an ostomy appliance comprising:.

wherein the outlet valve is attached to an outer face of the ostomy bag. In the closed configuration the outlet element may substantially overlie a cavity of the ostomy bag; and in the open configuration at least a portion of the outlet element may extend across a lower edge of the cavity of the ostomy bag.

A continuous first seal is configured to provide sealing between the cap and the axle around a circumference of the axle. A distance between the first seal and a basal end of the axle varies around the circumference of the axle.

As described above, the seal provides sealing between the cap and the axle around a circumference of the axle and sealing between the intake opening and the valve opening when the outlet element is in the closed configuration. Accordingly, in some embodiments there is provided an outlet valve for an ostomy appliance comprising: an axle defining a hollow bore for receiving a liquid output from the ostomy appliance, the axle comprising a curved lateral wall; and an outlet element comprising a cap arranged concentrically with the axle and an outlet tube affixed to the cap; wherein a valve opening is defined in the curved lateral wall; and the cap is rotatable around the axle to move from a closed configuration in which the valve opening is not in liquid communication with the outlet tube to an open configuration in which the valve opening is in liquid communication with the outlet tube; wherein the outlet valve further comprises at least one seal configured to provide sealing between the cap and the axle around a circumference of the axle and sealing between the intake opening and the valve opening when the outlet element is in the closed configuration, wherein the at least one seal comprises a continuous first seal configured to provide sealing between the cap and the axle around a circumference of the axle and wherein the distance between the first seal and a basal end of the axle varies around the circumference of the axle.

Additionally, or alternatively, the first seal may follow a curved or stepped path around the curved lateral wall.

Additionally, or alternatively, at a first circumferential position of the axle, the first seal may be at a distance from the basal end that is less than or equal to a distance from the basal end to a proximal edge of the valve opening. At second circumferential position of the axle, the first seal may be at a distance from the basal end that is greater than or equal to a distance from the basal end to a distal edge of the valve opening. The first circumferential position may be opposite the second circumferential of the annular seal. The outlet element may be rotatable to a fully open position wherein; the outlet element is in the open configuration; and wherein the intake opening is fully aligned with the valve opening. In the position, such that the first seal is arranged between the intake opening and the valve opening. The first circumferential position may be a circumferential position of the valve opening.

Additionally, or alternatively, an annular second seal may be arranged around a circumference of the axle. A distance between the annular second seal and a basal end of the axle may be constant around the circumference of the axle. The annular second seal may be arranged between the basal end of the axle and a proximal edge of the valve opening.

Additionally, or alternatively, the outlet tube may comprise an intake opening, wherein the outlet tube is configured to rotate with the cap such that on rotation of the cap the intake opening of the outlet tube is moved between an open configuration in which the intake opening is in liquid communication with the valve opening and a closed configuration in which the intake opening is not in liquid connection with the valve opening. In the open configuration at least a part of the intake opening may be arranged between the valve opening and the first seal such that at least a portion of the intake opening is in liquid communication with the valve opening.

Additionally, or alternatively, the cap may comprise a curved cap wall defining a generally cylindrical cavity for receiving the axle such that the axle is rotatably arranged within the curved cap wall. The cap may further comprise a cap end portion extending across a front end of the generally cylindrical cavity.

Additionally, or alternatively, the axle may be arranged on a backing flange for attachment to an outer face of the ostomy appliance, and may protrude from the backing flange away from the outer face of ostomy appliance in use.

Additionally, or alternatively, an axis of rotation of the outlet element defined by the axle may be arranged perpendicular to the elongate axis of the outlet tube and optionally the axis of rotation may be perpendicular to the body of the ostomate in use.

One or more aspects of the disclosure will now be described, by way of example only, with reference to the accompanying drawings, embodiments falling under the claimed invention are described in <FIG>, in which:.

In the following description, the equivalent reference numerals are used in different aspects to denote equivalent or similar features.

Unless defined otherwise, all technical and scientific terms used in this specification have the same meaning as is commonly understood by the reader skilled in the art to which the claimed subject matter belongs. It is to be understood that the foregoing summary of the disclosure and the following examples are exemplary and explanatory only and are not restrictive of any subject matter claimed.

The following description is directed to exemplar aspects of the disclosure. The description of the aspects is not meant to include all the possible aspects of the disclosure that are claimed in the appended claims. Many modifications, improvements and equivalents which are not explicitly recited in the following aspects may fall within the scope of the appended claims. Features described as part of one aspect may be combined with features of one or more other aspects unless the context clearly requires otherwise.

In this specification, the use of the singular includes the plural unless the context clearly dictates otherwise. In this specification, the use of "or" means "and/or" unless stated otherwise. Furthermore, use of the term "including" as well as other forms, such as "include", "includes," and "included," is not limiting.

As used herein, ranges and amounts can be expressed as "about" a particular value or range. About also includes the exact amount. For example, "about <NUM>" means "about <NUM>" and also "<NUM>. " Generally, the term "about" includes an amount that would be expected to be within experimental error. The term "about" includes values that are within <NUM>% less to <NUM>% greater of the value provided. For example, "about <NUM>%" means "between <NUM>% and <NUM>%. " Also, by way of example, "about <NUM>" means "between <NUM> and <NUM>.

A first example outlet valve <NUM> for an ostomy appliance according to the present disclosure is shown in <FIG>. The ostomy appliance may comprise an ostomy bag <NUM> (shown in <FIG>) and the outlet valve <NUM>, the outlet valve <NUM> being attached to an outer face of the ostomy bag <NUM>, preferably to an outer face of an outer wall of the ostomy bag <NUM>.

The outlet valve <NUM> comprises an outlet element <NUM> and an axle <NUM> defining a hollow bore <NUM> for receiving a liquid output from the ostomy bag <NUM>. The outlet element <NUM> comprises a cap <NUM> arranged concentrically with the axle <NUM>, and an outlet tube <NUM> affixed to the cap <NUM>. The cap <NUM> is rotatable around the axle <NUM>, about an axis of rotation <NUM> defined by the axle <NUM>, to move the outlet element <NUM> from a closed configuration in which a valve opening <NUM> arranged through the axle <NUM> is not in liquid communication with the outlet tube <NUM> to an open configuration in which the valve opening <NUM> is in fluid communication with the outlet tube <NUM>.

The outlet valve <NUM> may be configured such that when the outlet element <NUM> is in the open configuration, a flow path for liquid from the ostomy bag <NUM> may be defined through the hollow bore <NUM>, through the valve opening <NUM> and the cap <NUM> and into the outlet tube <NUM> for discharge from an outlet opening <NUM> of the outlet tube <NUM>. In the closed configuration, flow of liquid along the flow path is interrupted such that liquid may not flow into the outlet tube <NUM>.

A valve base <NUM> of the outlet valve <NUM> may be configured for attachment to the outer face of the ostomy bag <NUM> and may comprise a backing flange <NUM> having a generally planar attachment face <NUM> arranged on a back side of the valve base <NUM> (i.e. a face configured to be proximal to the body of the ostomate in use). The generally planar attachment face <NUM> may be attachable to the outer face of the ostomy bag <NUM>, for example by welding or by using an adhesive. The valve base <NUM> may comprise the axle <NUM>. The axle may protrude from an outer face <NUM> of the backing flange <NUM>. The axle <NUM> may be integrally formed with the backing flange <NUM>, for example by moulding.

The valve opening <NUM> is provided through the axle <NUM> for receiving a liquid output from the ostomy bag <NUM>. The outlet valve <NUM> may be arranged overlying an ostomy bag aperture provided in a wall of the ostomy bag <NUM>. Liquid from the ostomy bag aperture may thereby pass through the hollow bore <NUM> to the valve opening <NUM>. When the outlet element <NUM> is in the closed configuration, the valve opening <NUM> is not in liquid communication with the outlet tube <NUM>. When the outlet element <NUM> is in the open configuration the valve opening <NUM> is in liquid communication with the outlet tube <NUM>.

The axle <NUM> may comprise a curved lateral wall 13a and an axle end wall 13b, the axle end wall 13b being arranged across the hollow bore <NUM>. The axle end wall 13b may be generally planar. The axle end wall 13b may be arranged transverse and optionally perpendicular to the axis of rotation <NUM> defined by the axle <NUM>.

The valve opening <NUM> may be defined in a portion of the axle end wall 13b, as shown in <FIG>. The valve opening <NUM> may have a generally circular shape. A gasket seal <NUM> may be arranged around a periphery of the valve opening <NUM> to seal between the axle end wall 13b and a portion of the cap <NUM> around the periphery of the valve opening <NUM> such that liquid cannot pass into any space defined between the axle end wall 13b and the cap <NUM>.

The cap <NUM> may comprise an inner wall, the inner wall comprising an inner side wall portion 22a which may be generally cylindrical and an inner cap end portion 22b. The inner side wall portion 22a may define a generally cylindrical cavity for receiving the axle <NUM> such that the axle <NUM> is rotatably arranged within the inner wall.

The inner cap end portion 22b may be generally planar. It may be arranged across the generally cylindrical cavity such that it overlies the axle end wall 13b. The gasket seal <NUM> may be arranged on the axle end wall 13b around a periphery of the valve opening <NUM> to seal between the axle end wall 13b and a generally planar back face of the inner cap end portion 22b.

The intake opening <NUM> may be provided in the inner cap end portion 22b and may be in liquid communication with the outlet tube <NUM>. The intake opening <NUM> being arranged to be rotatable into a position in which the intake opening <NUM> at least partially aligns with the valve opening <NUM> to define a liquid path therethrough, such that the outlet element <NUM> is in the open configuration. The intake opening <NUM> may have a width which is substantially equal to a diameter of the valve opening <NUM>. The intake opening <NUM> may have an arcuate shape aligned with a circumference around the axis of rotation <NUM>, a central axis 15a of the valve opening <NUM> being arranged on the same circumference. The arcuate shape may allow the full alignment of the valve opening <NUM> with the intake opening <NUM> at a range of angular positions of the cap <NUM>. A protrusion 23b may be provided across at least a part of the intake opening <NUM> to partially compress the gasket seal while the gasket seal <NUM> is adjacent to the intake opening <NUM>. This may limit bulging of the gasket seal <NUM> into the opening 23b and so may limit pinching or slicing of the gasket seal <NUM> on contact with the edges of the intake opening <NUM> on movement of the cap <NUM>.

The cap <NUM> may comprise an outer wall arranged concentrically around the inner wall such that a flow space <NUM> is defined between the inner wall and the outer wall, the flow space <NUM> being in liquid communication with the outlet tube <NUM>. The intake opening <NUM> may provide a liquid flow path into the flow space <NUM> from the valve opening <NUM>. The outer wall may comprise an outer side wall portion 22c and an outer cap end portion 22d, wherein the outer cap end portion 22d overlies the inner cap end portion 22b and is axially spaced from the inner cap end portion 22b such that at least a portion of the flow space <NUM> is arranged between the outer cap end portion 22d and the inner cap end portion 22b. The outer cap end portion 22d may be formed as a separate part to facilitate manufacture and assembly of the cap <NUM> and may be affixed to the outer side wall portion 22c by adhesive or mechanical clips. A seal (not shown) may be provided between the outer cap end portion 22d and the outer side wall portion 22c.

The inner side wall portion 22a and the outer side wall portion 22c may be joined at their basal ends (i.e. the end proximal to the backing flange <NUM> of the valve base <NUM>) by an annular flange such that there is no liquid flow path out of the flow space <NUM> at the basal end of the cap <NUM>.

The axle <NUM> may be retained in the cap <NUM> by one or more retention features. The retention features may be in the form of one or more interengaging protrusions 26a, 26b arranged on an outer face of the curved lateral wall 13a of the axle <NUM> and an inner face of the inner side wall portion 22a. The interengaging protrusions 26a, 26b may be configured to prevent axial movement of the cap <NUM> relative to the axle <NUM> during rotation.

A further seal <NUM> maybe arranged between an outer face of the curved lateral wall 13a of the axle <NUM> and an inner face of the inner side wall portion 22a at a basal end of the axle <NUM> to prevent fluid egress between the cap <NUM> and the axle <NUM> at the basal end of the axle <NUM>.

One or more detents <NUM> may be provided on the backing flange <NUM> of the valve base <NUM> for co-operating with one or more recesses or protrusions arranged on the cap <NUM>. The detent(s) <NUM> may be positioned to provide audible and/or tactile feedback to confirm the rotation position of the outlet element <NUM> to the user, and thereby to confirm when the outlet element <NUM> is in the open and/or closed configurations.

The outlet tube <NUM> may extend laterally from the cap <NUM> such that the axis of rotation <NUM> of the outlet element <NUM> defined by the axle <NUM> is perpendicular to an elongate axis 21a of the outlet tube <NUM>.

In use, the outlet element <NUM> may be rotatable such that the outlet tube <NUM> moves through an arc of rotation from an upward-pointing position at a first end of the arc of rotation to a downward-pointing position at a second end of the arc of rotation (as shown in <FIG>).

At the first end of the arc of rotation, the outlet element <NUM> may be in the closed configuration. The user may rotate the outlet element <NUM> downwards by rotating the cap <NUM> to a limit position. The limit position may be defined at a point on the arc of rotation furthest from its first end at which the outlet element <NUM> is still in the closed configuration. As the outlet element <NUM> is rotated from the limit position towards the second end of the arc of rotation the valve opening <NUM> and the intake opening <NUM> will become gradually move into alignment, increasing the area of the flow path gradually until reaching a fully open configuration in which the valve opening <NUM> and the intake opening <NUM> are aligned. The position at which the outlet element is in a fully open configuration, i.e. in which the base and intake openings are fully aligned, may coincide with the second end of the arc of rotation.

Therefore, at the first end of the arc of rotation the outlet element <NUM> may be in a fully closed position in which the valve opening <NUM> is obstructed by the inner cap end portion 22b such that no liquid may pass from the hollow bore <NUM> of the axle <NUM> to the flow space <NUM> through the valve opening <NUM>. At the second end of the arc of rotation, the outlet element <NUM> may be in a fully open position in which the intake opening <NUM> is fully aligned with the valve opening <NUM>.

The circumferential position of the valve opening <NUM> and the intake opening <NUM> may be arranged such that when the intake opening <NUM> is fully aligned with the valve opening <NUM> and the outlet element <NUM> is in the open configuration, the outlet tube <NUM> is directed generally downwards. At the first end of the arc of rotation, with the outlet element in the closed configuration, an outlet opening <NUM> of the outlet tube <NUM> may be arranged generally upward and/or may overlie the backing flange <NUM>.

The outlet valve <NUM> may be configured such that, in use, the axis of rotation <NUM> is arranged generally horizontally but perpendicular to an attachment face <NUM> of the backing flange <NUM> of the valve base <NUM>.

Further examples of an outlet valve according to the present disclosure are described below. Only those features that differ in this aspect compared to the previous aspect will be described in detail in the following description. For features that are common to one or more aspects, reference should be made to the description as a whole.

A second example outlet valve <NUM> according to the present invention is shown in <FIG>. The outlet valve <NUM> comprises an axle <NUM> and a cap <NUM>.

A valve base <NUM> of the outlet valve <NUM> may comprise a backing flange <NUM> and the axle <NUM>, the axle <NUM> defining the hollow bore <NUM>. The axle <NUM> may be moulded as a separate component to the backing flange <NUM>, the axle <NUM> being affixed to the backing flange <NUM>, for example using a snap or interference fit of retention features 126a and 126b as shown in <FIG> and <FIG>. No liquid path may be defined through the axle end wall 113b.

A valve opening <NUM> is provided through the axle <NUM> for receiving a liquid output from the ostomy bag. The axle <NUM> may comprise a curved lateral wall 113a and an axle end wall 113b, the axle end wall 113b being arranged across the hollow bore <NUM>.

The axle <NUM> may extend through the full height of the valve such that the axle end wall 113b comprises a front face of the outlet valve <NUM> (i.e. it is not covered by the cap <NUM> of the outlet element <NUM>).

The valve opening <NUM> may be defined in a portion of the curved lateral wall 113a of the axle <NUM> as shown in <FIG> and <FIG>.

An outlet element <NUM> of the outlet valve <NUM> may comprise the cap <NUM> and an outlet tube <NUM>. The cap <NUM> may comprise a curved cap wall 122a defining a generally cylindrical cavity for receiving the axle <NUM> such that the axle is rotatably arranged within the curved cap wall 122a. The cap <NUM> may therefore have a generally annular shape.

The outlet tube <NUM> may be integrally formed with or affixed to the cap <NUM>. The outlet tube <NUM> comprises an intake opening <NUM> at its inner end, arranged through the curved cap wall 122a. The intake opening <NUM> may be configured to receive liquid from the valve opening <NUM> when the outlet valve <NUM> is in the open configuration.

The cap <NUM> may be arranged concentrically with the axle <NUM> such that the cap <NUM> is rotatable about the axle <NUM>. The outlet tube <NUM> may be affixed to the cap <NUM> such that it rotates with the cap <NUM> about the axle <NUM>. Therefore, on rotation of the outlet element <NUM> including the cap <NUM> the intake opening <NUM> of the outlet tube <NUM> may be moved between an open position in which the intake opening <NUM> is in liquid communication with the valve opening <NUM> (such that the outlet element is in the open configuration) and a closed position in which the intake opening <NUM> is not in liquid connection with the valve opening <NUM> (such that the outlet element is in the closed configuration).

A circumferential position of the valve opening <NUM> around the axle <NUM> may be arranged such that when the intake opening <NUM> is aligned with the valve opening <NUM>, i.e. the outlet element <NUM> is in the open configuration, the outlet tube <NUM> is directed generally downwards. The intake opening <NUM> may have a shape and size which is substantially the same as the size and shape of the valve opening <NUM>. The intake opening <NUM> and the valve opening <NUM> may be arranged at the same axial distance from the valve base <NUM>.

A first seal 116a may be provided to seal between the cap <NUM> and the axle <NUM> around a perimeter of the intake opening <NUM> when the outlet element <NUM> is in the closed configuration. The first seal 116a may be integrally formed with a second seal 116b configured to provide sealing between the cap <NUM> and the axle <NUM> around a circumference of the axle <NUM>.

The first seal 116a may comprise a gasket seal arranged on the curved cap wall 122a of the axle, the first seal 116a being spaced apart from the intake opening <NUM> around the circumference of the axle <NUM>.

The gasket seal forming the first seal 116a may have a profile corresponding to the shape of the intake opening <NUM>. When the outlet element <NUM> is in the closed position, the first seal 116a may be aligned with and arranged around a periphery of the intake opening <NUM>, thereby providing a seal between the intake opening <NUM> and the curved lateral wall of the axle <NUM> such that the outlet tube <NUM> is not in liquid communication with the valve opening <NUM>.

The second seal 116b may be arranged around the circumference of the axle <NUM> between the curved cap wall 122a and the axle <NUM>, at an axial position between the valve opening <NUM> and a front end of the curved cap wall 122a (i.e. an end of the curved cap wall distal to the backing flange <NUM> of the valve base <NUM>.

The first seal 116a and second seal 116b may be configured to be stationary relative to the axle <NUM>. The first seal 116a and second seal 116b may be attached to the axle <NUM> such that they do not rotate relative to the axle <NUM> on rotation of the cap <NUM>, for example due to resilience of the first and second seals 116a, 116b, using adhesive or by provision of a groove on the axle <NUM> on in which the first seal 116a and second seal 116b may be received.

In use, the outlet element <NUM> may be rotatable such that the outlet tube <NUM> moves through an arc of rotation from an upward-pointing position at a first end of the arc of rotation to a downward-pointing position at a second end of the arc of rotation. At the first end of the arc of rotation, the outlet element <NUM> may be in the closed configuration. The user may rotate the outlet element <NUM> downwards by rotating the cap <NUM> to a limit position. The limit position may be defined at a point on the arc of rotation furthest from its first end at which the outlet element <NUM> is still in the closed configuration. As the outlet element <NUM> is rotated from the limit position towards the second end of the arc of rotation the intake opening <NUM> will become gradually move out of alignment with the first seal 116a such that a flow path is defined from the valve opening <NUM> through the flow space <NUM> to the intake opening <NUM>. As the outlet element <NUM> is rotated further from the first end of the arc of rotation, the area of the flow path may gradually increase until the outlet element <NUM> reaches a reaching a fully open position in which the valve opening <NUM> and the intake opening <NUM> are aligned. The fully open position may coincide with the second end of the arc of rotation.

A third, circumferential seal <NUM> may be arranged between the valve base <NUM> and the cap <NUM> (as shown in <FIG> and <FIG>). The third, circumferential seal <NUM> may be arranged between backing flange <NUM> and the cap <NUM>, for example being received in a recess provided in a basal face of the curved cap wall 122a and abutting a sealing protrusion 111a provided on a front face of the backing flange <NUM>. The third, circumferential seal <NUM> may therefore provide a seal between the valve base <NUM> and the cap <NUM> adjacent to a basal end of the axle <NUM> such that fluid entering a flow space <NUM> between the cap <NUM> and the axle <NUM> cannot pass out of the outlet valve <NUM> between the cap <NUM> and the valve base <NUM>. In an alternative example, the third, circumferential seal <NUM> may be arranged between the axle <NUM> and the cap <NUM>.

The relative axial positions of the backing flange <NUM>, the axle <NUM> and the outlet element <NUM> may be fixed using retention features, for example in the form of a pair of basal flanges 126a provided at a basal end of the axle <NUM> and a distal flange 126b provided at a distal end of the axle <NUM>. An aperture may be provided in the backing flange <NUM> to receive the axle <NUM>. The pair of basal flanges 126a may be configured to receive a portion of the backing flange <NUM> therebetween to provide a push-fit assembly of the axle <NUM> to the backing flange <NUM>. The distal flange 126b may extend outwards from the axle <NUM> to retain the outlet element <NUM> between the distal flange 126b and the backing flange <NUM>.

A third example outlet valve <NUM> according to the present invention is shown in <FIG>. The outlet valve <NUM> comprises an axle <NUM> and a cap <NUM>.

A valve base <NUM> of the outlet valve <NUM> may comprise a backing flange <NUM> and the axle <NUM>, the axle <NUM> defining the hollow bore <NUM>. The axle <NUM> may be integrally formed with the backing flange <NUM>, for example by forming these as a single moulding.

A valve opening <NUM> is provided through the axle <NUM> for receiving a liquid output from the ostomy bag. The axle <NUM> comprises a curved lateral wall 213a and an axle end wall 213b, the axle end wall 213b being arranged across the hollow bore <NUM>. No liquid path may be defined through the axle end wall 113b. The valve opening <NUM> is defined in a portion of the curved lateral wall 213a of the axle <NUM> as shown in <FIG> and <FIG>.

An outlet element <NUM> of the outlet valve <NUM> may comprise the cap <NUM> and an outlet tube <NUM>. The cap <NUM> may comprise a curved cap wall 222a defining a generally cylindrical cavity for receiving the axle <NUM> such that the axle is rotatably arranged within the curved cap wall. The cap <NUM> may further comprise a cap end wall 222b arranged across and sealing the distal end of the generally cylindrical cavity.

The outlet tube <NUM> may be integrally formed with or affixed to the cap <NUM>. The outlet tube <NUM> comprises an intake opening <NUM> at its inner end, arranged through the curved cap wall 222a. The intake opening <NUM> may be configured to receive liquid from the valve opening <NUM> when the outlet valve <NUM> is in the open configuration.

The cap <NUM> may be arranged concentrically with the axle <NUM> such that the cap <NUM> is rotatable about the axle <NUM>. The outlet tube <NUM> may be affixed to the cap <NUM> such that it rotates with the cap <NUM> about the axle <NUM>. Therefore, on rotation of the cap <NUM> the intake opening <NUM> of the outlet tube <NUM> may be moved between an open position in which the intake opening <NUM> is in liquid communication with the valve opening <NUM> and a closed position in which the intake opening <NUM> is not in liquid connection with the valve opening <NUM>.

The intake opening <NUM> may have a shape and size which is substantially the same as the size and shape of the valve opening <NUM>. The intake opening <NUM> and the valve opening <NUM> may be arranged at the same axial distance from the valve base <NUM>.

On rotation of the cap <NUM>, the outlet element <NUM> is moved between an open configuration in which the intake opening <NUM> is in liquid communication with the valve opening <NUM> and a closed configuration in which the intake opening <NUM> is not in liquid connection with the valve opening <NUM>. A circumferential position of the valve opening <NUM> around the axle <NUM> may be arranged such that when the intake opening <NUM> is aligned with the valve opening <NUM>, i.e. the outlet element <NUM> is in the open configuration, the outlet tube <NUM> is directed generally downwards.

The outlet valve may further comprise a first seal <NUM>, which may be continuous, configured to provide sealing between the cap <NUM> and the axle <NUM> around a circumference of the axle <NUM>. The first seal <NUM> may follow a curved or stepped path around the curved lateral wall 213a of the axle <NUM> such that a distance between the first seal <NUM> and a basal end of the axle <NUM> varies around the circumference of the axle <NUM>, as measured parallel to an axis of rotation <NUM> defined by the axle <NUM>. The number or complexity of seals required to seal the outlet valve <NUM> may therefore be reduced.

At a first circumferential position of the axle <NUM>, the first seal <NUM> may be positioned at a distance from the basal end of the axle <NUM> that is less than or equal to a distance from the basal end of the axle <NUM> to a proximal edge 215a of the valve opening <NUM>. The first circumferential position may be a circumferential position of the of the valve opening <NUM>. The first circumferential position may extend around an arc of the circumference corresponding to the arc of the circumference along which the valve opening <NUM> extends.

At a second circumferential position of the axle <NUM>, the first seal <NUM> is at a distance from the basal end of the axle <NUM> that is greater than or equal to a distance from the basal end of the axle <NUM> to a distal edge 215b of the valve opening. The second circumferential position may extend around an arc of the circumference corresponding to the arc of the circumference along which the valve opening <NUM> is arranged when the outlet element <NUM> is in the closed configuration.

The first circumferential position may be arranged opposite the second circumferential of the first seal <NUM>, i.e. the first circumferential position may be arranged approximately <NUM> degrees around the circumference of the axle <NUM> from the second circumferential position.

An annular second seal <NUM> may be arranged around a circumference of the axle <NUM> for sealing a flow space <NUM> arranged between the cap <NUM> and the axle <NUM> adjacent to the basal end of the axle <NUM>. The annular second seal <NUM> may be arranged between the basal end of the axle <NUM> and the first seal <NUM> such that the annular second seal <NUM> may be arranged between the basal end of the axle <NUM> and a proximal edge 215a of the valve opening <NUM>. A distance between the annular second seal <NUM> and a basal end of the axle <NUM> may be constant around the circumference of the axle <NUM>.

In use, the outlet element <NUM> may be rotatable such that the outlet tube <NUM> moves through an arc of rotation from an upward-pointing position at a first end of the arc of rotation to a downward-pointing position at a second end of the arc of rotation. At the first end of the arc of rotation, the outlet element <NUM> may be in the closed configuration. In the closed configuration, the intake opening <NUM> may be arranged at the second circumferential position, such that the first seal <NUM> is arranged between the intake opening <NUM> and the valve opening <NUM>.

The user may rotate the outlet element <NUM> downwards by rotating the cap <NUM> to a limit position. The limit position may be defined at a point on the arc of rotation furthest from its first end at which the outlet element <NUM> is still in the closed configuration. As the outlet element <NUM> is rotated from the limit position towards the second end of the arc of rotation the intake opening <NUM> will gradually move across a portion of the first seal <NUM> such that a flow path is defined from the valve opening <NUM> through the flow space <NUM> to the intake opening <NUM>. As the outlet element <NUM> is rotated further from the first end of the arc of rotation, the area of the flow path may gradually increase until the outlet element <NUM> reaches a reaching a fully open position in which the valve opening <NUM> and the intake opening <NUM> are aligned. The fully open position may coincide with the second end of the arc of rotation. In the open configuration, at least a portion of the intake opening <NUM> is arranged between the valve opening <NUM> and the first seal <NUM>.

When the outlet element <NUM> is in the open configuration at least a part of the intake opening <NUM> is arranged between the valve opening <NUM> and the first seal <NUM> in the liquid flow path through the outlet valve <NUM> such that at least a portion of the intake opening <NUM> is in liquid communication with the valve opening <NUM>.

The relative axial positions of the axle <NUM> and the outlet element <NUM> may be fixed using retention features, for example in the form of an annular clip <NUM> provided between the cap <NUM> and the axle <NUM>.

In a further aspect of the present disclosure, an outlet valve according to any aspect of the present disclosure may form part of an ostomy appliance further comprising an ostomy bag. The outlet valve may be attached to an outer face of a wall of the ostomy bag for draining liquid from a cavity of the ostomy bag. An ostomy bag aperture may be provided through the wall; the backing flange of the outlet valve being affixed or attached to the wall such that the ostomy bag aperture is in fluid communication with the hollow bore. The outlet valve may therefore be operated to open and close a fluid pat out of the cavity of the ostomy bag.

The outlet valve may be arranged adjacent to a lower edge or apex of the ostomy bag. The outlet valve may be oriented such that in the closed configuration the outlet element may substantially overlie the cavity of the ostomy bag and in the open configuration at least a portion of the outlet element extends across a lower edge of the cavity of the ostomy bag.

Whilst preferred aspects of the present disclosure have been described, these are by way of example only and non-limiting. It will be appreciated by those skilled in the art that many alternatives are possible within the ambit of the disclosure. For example, features described as part of one aspect may be combined with features of one or more other aspects unless the context clearly requires otherwise. Further, the following features may be applicable to any aspect of the disclosure.

As noted above, in this specification locations and orientations of features may be described with reference to the ostomy appliance being "in use", "orientated as it would be in use" or similar. Such terms refer to the intended orientation of the ostomy appliance when it is adhered to a body of an ostomate with the ostomate in a standing position.

Any outlet valve according to the present disclosure may be configured such that when attached to an outer face of an ostomy bag in use, the axis of rotation of the outlet element may be arranged generally perpendicular to the elongate axis of the outlet tube and perpendicular to a generally planar attachment face of the backing flange such that the axis is generally perpendicular to the body of the ostomate in use.

In use, the outlet tube may be arranged in a storage position at the first end of the arc of rotation, the outlet element being in the closed configuration. In this storage position, the outlet tube may be oriented such that the outlet end is arranged generally upwards and overlies the backing flange. In the storage position the outlet tube may overlie a cavity of the ostomy bag.

To drain liquid from an ostomy appliance comprising an outlet valve according to any aspect of the present disclosure, the user may grip the outlet element and rotate the outlet tube along an arc of rotation away from the first, upward end of the arc of rotation. A limit position of the outlet element may be defined at a point on the arc of rotation furthest from its first end at which the outlet element is still in the closed configuration.

The limit position may provide a convenient position for the user to pause rotation of the valve and to attach a drain appliance such as a night bag to the outlet tube before the outlet tube is moved into the open configuration, thereby limiting the possibility of spillage of the output liquid. The outlet tube may then be rotated further to increase an area of the flow path from the base opening to the intake opening, for example by increasing the alignment of the base and intake openings or by moving the intake opening past a seal, and thereby allow more fluid to flow out of the valve, and to orient the outlet tube downwards for convenient drainage into the night bag or to the exterior.

In use, when the valve opening and intake opening are at least partially aligned or otherwise at least partially in liquid communication the outlet element is in the open configuration. As the outlet tube is moved from its limit position towards the second end of the arc of rotation the apertures will become gradually more aligned or an area of the flow path between them will increase until reaching a fully open position in which both apertures are aligned. The fully open position may coincide with the second end of the arc of rotation.

After drainage of the ostomy bag, or when the user wishes to interrupt the flow of liquid out of the outlet valve, the user may rotate the outlet tube upwards to move the outlet element back into the closed configuration. If used, a night drainage bag or other appliance can be disconnected from the outlet tube once the outlet element is in the closed configuration, avoiding spillages.

In any aspect, retention features may be provided for retaining the axle inside the cap. For example, these may comprise cooperating protrusions and/or recesses. The retention features may also be configured to prevent relative axial motion between the cap and the axle during rotation.

In any aspect, the valve opening may define the only fluid path out of the hollow bore away from the ostomy bag.

In any aspect, the outlet element and/or the valve base may be provided with detents configured to prevent accidental opening and/or to provide audible and/or tactile feedback confirming the rotational position of the outlet element, and therefore whether the outlet element is in the open or closed configuration, to the user. For example, a detent may be arranged at or near the limit position to indicate the point at which the outlet element is about to move into the open configuration.

In any aspect, one or more of the seals may be in the form of an O-ring.

In any aspect, the backing flange and the axle may be formed integrally, for example being formed as a single moulding, or may be formed separately and subsequently assembled such that the axle is affixed to the backing flange. If formed separately, assembly may occur after attachment of the backing flange to an ostomy bag. This may facilitate assembly, as the height of the axle would not need to be accommodated by the assembly machinery (for example, a welding apparatus) during attachment of the backing flange to the ostomy bag.

In any aspect, at least a portion of the outlet tube may be formed integrally with the cap. Alternatively, the outlet tube may be formed separately and subsequently affixed to the cap.

In any aspect, the outlet tube may comprise a relatively rigid intake portion and a relatively flexible outlet portion. The relatively flexible outlet portion may be affixed to the relatively rigid intake portion in any suitable manner, for example by over-moulding the relatively flexible outlet portion onto the relatively rigid intake portion. The relatively flexible outlet portion may be resilient. The outlet valve according to any aspect of the disclosure may be configured for use with a relatively rigid connector, for example for connecting the outlet valve to a drainage bag or other appliance. The relatively rigid connector may have an outer diameter and the relatively flexible outlet portion of the outlet tube may have an outlet diameter marginally smaller than the connector outer diameter such that, on insertion of the connector into the relatively flexible outlet tube portion in use, the relatively flexible outlet tube portion may flex to accommodate the connector and thereby form an effective seal.

In any aspect, the seal(s) may be stationary (i.e. do not rotate) relative to the axle in use. One or more seals may be affixed to the axle.

A lubricant may be provided between the rotating components to ease rotation and improve sealing.

In any aspect of the present disclosure, the outlet element may be retained in an axial direction relative to the housing, such that there is no relative axial movement between the outlet element and the valve base during rotation.

Other features of the ostomy appliance, for example the shape and construction of the ostomy appliance inner and outer walls and comfort layer, may vary from those shown in the illustrated aspects. Similarly, the shape of the valve opening may vary from those shown in the illustrated aspects.

Claim 1:
An outlet valve (<NUM>) for an ostomy appliance comprising:
an axle (<NUM>) defining a hollow bore (<NUM>) for receiving a liquid output from the ostomy appliance, the axle (<NUM>) comprising a curved lateral wall (213a); and
an outlet element (<NUM>) comprising a cap (<NUM>) arranged concentrically with the axle (<NUM>) and an outlet tube (<NUM>) affixed to the cap (<NUM>);
wherein a valve opening (<NUM>) is defined in the curved lateral wall (213a); and
the cap (<NUM>) is rotatable around the axle (<NUM>) to move from a closed configuration in which the valve opening (<NUM>) is not in liquid communication with the outlet tube (<NUM>) to an open configuration in which the valve opening (<NUM>) is in liquid communication with the outlet tube (<NUM>);
wherein the outlet valve (<NUM>) further comprises at least one seal configured to provide sealing between the cap (<NUM>) and the axle (<NUM>) around a circumference of the axle (<NUM>) and sealing between an intake opening (<NUM>) of the outlet tube (<NUM>) and the valve opening (<NUM>) when the outlet element (<NUM>) is in the closed configuration; and
wherein the at least one seal comprises a continuous first seal (<NUM>) configured to provide sealing between the cap (<NUM>) and the axle (<NUM>) around a circumference of the axle (<NUM>) and wherein the distance between the first seal (<NUM>) and a basal end of the axle (<NUM>) varies around the circumference of the axle (<NUM>).