Patent Description:
Urostomy appliances are well known in the field. They are typically attached to a patient via an adhesive wafer that extends around the patient's stoma with adhesive and provide a collecting chamber to collect waste (mostly liquid waste) exiting the stoma. A mechanism for draining the collecting chamber is often provided - typically, these are in the form of a tap or bung, which allow the patient to open an outlet from the urostomy appliance and drain the contents, for example, into a toilet.

<CIT> discloses a urine drainage bag including a tap. The tap includes a tap member mounted to the housing so as to be pivotably movable between a closed, stowed position and an open, deployed position.

The current invention aims to alleviate one or more problems associated with to prior art urostomy appliance valves.

According to a first aspect of the present invention we provide a valve for a urostomy appliance including: a body for connection to the urostomy appliance, an inlet and an outlet, connected by a flow path, and a blocking member supported by the body and generally linearly moveable between a closed position, in which the blocking member blocks the inlet, such that liquid cannot flow through the flow path to the outlet, and an open position in which the inlet is open, such that liquid is permitted to flow through the flow path to the outlet, and a cover member which is moveable between an open position, in which liquid is permitted to flow through the outlet, and a closed position, in which liquid is prevented or inhibited from flowing through the outlet, and wherein the cover member is biased towards its open position, and wherein the cover member includes a holding formation and the blocking member includes a corresponding formation, such that when the holding formation engages the corresponding formation the cover member is held in its closed position.

Additional features of the present invention are outlined in the appended claims.

With reference to <FIG>, particularly, a urostomy appliance <NUM> is illustrated. The urostomy appliance <NUM> includes first and second walls 2a, 2b which are connected together (for example, via a heat weld) to form a waste collecting cavity <NUM>. The first wall 2a is attached to an adhesive wafer <NUM>. An aperture (known as a stoma receiving opening <NUM>) extends through both the first wall 2a and the adhesive wafer <NUM> to provide an entrance to the waste collecting cavity <NUM>.

A valve <NUM> (described in more detail below) is attached to the second wall 2b of the urostomy appliance <NUM>. The valve <NUM> communicates with the waste collecting cavity <NUM> and has an open and a closed position, in which waste is or is not permitted to flow through the valve <NUM> (i.e. flow out of the waste collecting cavity <NUM>).

In use, the patient attaches the adhesive wafer <NUM> around their stoma. Waste liquid (for example, urine and/or blood and/or other body fluids) exits the body, via the stoma, and flows through the stoma receiving opening <NUM> and is collected in the waste collecting cavity <NUM>. The valve <NUM> is selectively used to permit the waste which is collected in the waste collecting cavity <NUM> to flow out of the appliance <NUM>, through the valve <NUM> (so that, for example, the appliance <NUM> can be emptied of some/most/all of the contents).

Features of the valve <NUM> are shown in more detail in <FIG>. The valve <NUM> includes a body <NUM> for connection to the urostomy appliance <NUM>, an inlet <NUM>, and an outlet <NUM>, which are connected by a flow path, and a blocking member <NUM>, which is supported by the body <NUM>.

In some embodiments (see particularly <FIG>, <FIG> and <FIG>), the body <NUM> includes a tip that has a rounded and narrowed end <NUM> and a wider base part <NUM>. In this case, the inlet <NUM> is defined by the body <NUM> (for example, the inlet <NUM> is formed adjacent the narrowed end of the body <NUM> and communicates with a body passage <NUM> that extends through part of the body <NUM>. In some embodiments, the body <NUM> includes a further inlet (i.e. there are two inlets <NUM> in total). The further inlet is located on the opposing "side" of the body <NUM>. In other words, the further inlet is positioned so that it also communicates with the body passage <NUM>. In such a design, the further inlet is opened and closed synchronously with the inlet <NUM> (by the movement of the blocking member <NUM>). It should be appreciated that two such inlets <NUM> are not necessarily required and there may be fewer or more as desired in a specific design.

In some embodiments, the inlet (or inlets) <NUM> are shaped in one of a tear-drop, egg/oval, trapezoidal, pentagonal or kite shape when viewed in a direction liquid passes therethrough.

In the illustrated embodiment, the body <NUM> also includes a channel <NUM>. The channel <NUM> extends away from an entrance/exit of the body passage <NUM> and provides support for the blocking member <NUM> (the function of the channel <NUM> is described in more detail below).

The body <NUM> is connected to the urostomy appliance <NUM> by a heat weld (not shown) around the body <NUM>, such that the inlet <NUM> communicates with the waste collecting cavity <NUM> (for example, the heat weld may extend across the base part <NUM> of the body <NUM>, such that the narrowed end <NUM> and inlet <NUM> is in the urostomy appliance <NUM> / waste collecting cavity <NUM>). It should be appreciated that the body <NUM> need not be heat welded necessarily. The body <NUM> may be attached to the appliance <NUM> in another manner that permits the inlet <NUM> to communicate with the waste collecting cavity <NUM>.

The embodiment illustrated in <FIG> shares the features of the valve <NUM> described in relation to the other figures (but only some features are labelled explicitly). In this case, the base part <NUM> of the body <NUM> includes two projections 13a which extend outwards from the sides of the base part <NUM>. Each projection 13a includes an upper surface and a lower surface, which are inclined with respect to each other so that the edge furthest from the base part <NUM> is narrow (in the illustrated version, the upper and lower surfaces form a point at the edge furthest from the base part <NUM>). The side projections 13a improve the manufacturing process by making the heat weld between the body <NUM> and urostomy appliance <NUM> easier to form because the films (or the urostomy appliance <NUM>) that form the seal around the valve <NUM> (that seal around the entire base part <NUM>) form a smoother, less extreme curve, around the projections 13a than if there were no projections present. It should be appreciated that any embodiment may include this feature, as desired.

In some embodiments, a main part of the body <NUM> (i.e. the top and wider base part forming the body passage <NUM> and the channel <NUM>) is made of a first material. The body <NUM> also includes a guide channel <NUM> (see <FIG> and <FIG>), which is integrally formed (in this case, along a base of the channel <NUM>). The guide channel <NUM> is made of a second material. The second material is more rigid than the first material.

The first material may be relatively pliable which means the body <NUM> is deformable and can be distorted reasonably easily. This allows the body <NUM> to be attached and sealed to the urostomy appliance <NUM> relatively easily but may make the body <NUM> more prone to damage if it is handled carelessly by a user (for example, if the valve <NUM> is squashed/distorted repeatedly). By including a second material to form a guide channel <NUM> that is more rigid than the rest of the body <NUM> may reduce distortion of the body <NUM> and may result in less damage being inflicted on the valve <NUM> during its useable life. It should be appreciated that this configuration may only be necessary if such the first material used for the body <NUM> is pliable / distortable. In some embodiments, the body <NUM> may be made from a first material that provides enough rigidity for the valve to operate as desired. It should also be appreciated that the first and second materials may be the same material but formed differently to provide different physical characteristics (e.g. two forms of PTFE).

It should be appreciated that the body <NUM> and the blocking member <NUM> may be manufactured using an overmoulding process. The blocking member <NUM> and/or the body <NUM> may be overmoulded with a rubber or rubber-like material.

The blocking member <NUM> is supported by the body <NUM> and is moveable between a closed position and an open position (as illustrated in <FIG>, respectively). In the illustrated example, the blocking member <NUM> is generally linearly moveable between its closed open positions (and vice versa), but this does not necessarily have to be the case.

In the illustrated embodiments, the blocking member <NUM> includes a blocking portion <NUM> and a user operable part <NUM>. A passage extends through the blocking member <NUM> (in this case, through both the blocking portion <NUM> and the user operable part <NUM>) to connect to the outlet <NUM>. In the present example, the opening extends substantially centrally, but this need not be the case.

When the valve <NUM> is assembled, and the blocking member <NUM> is in its closed position, the blocking portion <NUM> is received in the body passage <NUM> and the user operable portion <NUM> is received by the channel <NUM> (see <FIG>). Thus, the passage through the blocking member <NUM> communicates with the body passage <NUM> through the body <NUM> to provide the flow path (between the inlet <NUM> and the outlet <NUM>) through the valve <NUM> (whether the flow path is open for liquid to flow through depends on the position of the blocking member <NUM> in the body passage <NUM>).

In some embodiments, the blocking member <NUM> is received and supported by the guide channel <NUM>. The channel <NUM> prevents or at least inhibits movement of the blocking member <NUM> that is not generally linear with respect to the body <NUM>. In some embodiments, the guide channel <NUM> inhibits non-coaxial movement of the blocking member <NUM> when the blocking member <NUM> is moved between its closed and open positions.

In some embodiments, the guide channel <NUM> includes a formation <NUM> (see <FIG>) that engages a corresponding formation on the blocking member <NUM>. Such a formation <NUM> and corresponding formation may provide additional guidance for the blocking member <NUM> as it is moved between its open and closed positions. It should be appreciated that such a formation and corresponding formation may not be present.

In some embodiments, the formation <NUM> of the guide channel includes one or more formations, each of which extends along the guide channel <NUM> in the direction of movement of the blocking member <NUM>. The corresponding formation on the blocking member <NUM> includes at least one further formation. When the respective formations engage with each other (i.e. as the blocking member <NUM> moves), they inhibit any movement apart from generally linear movement of the blocking member <NUM>. The formations could be axially extending projections/ridges and may be positioned on the base of the guide channel <NUM> or on each side of the guide channel <NUM>, for example.

In some examples, the user operable portion <NUM> includes a depression <NUM> to aid user control. In some examples, the depression <NUM> also has a textured surface. These features aid user control by providing an area for a finger or thumb to be placed and provide the force required to slide open the valve <NUM>.

In some embodiments, the valve <NUM> has an indicator that allows a user to feel when the valve <NUM> is in a fully open position. For example, the channel <NUM> may include an upward projection. When the blocking member <NUM> is moved to its open position (i.e. linearly outwards from the body <NUM>) a part may pass over the projection and provide an indication that the blocking member <NUM> is in its fully open position. This allows the user to be confident that the valve <NUM> is fully open.

Likewise, another indicator could be used to inform the user when the valve <NUM> is in a closed position. This would allow a user to be confident that the valve <NUM> is closed and will not leak, for example.

In some embodiments, the valve <NUM> includes a cover member <NUM>. The cover member <NUM> is moveable between an open position (see <FIG>) and a closed position (see <FIG>). When the cover member <NUM> is in its open positon, liquid is permitted to flow through the outlet <NUM>, and when the cover member <NUM> is in its closed position, liquid is prevented or at least inhibited from flowing through the outlet <NUM>.

In some embodiments, the cover member <NUM> pivots downwardly and towards a user wearing the urostomy appliance <NUM> when it is moved to its open positon when the cover member <NUM> is moved or moves to its open position. In other words, when the cover member <NUM> is in its open position it may be located between the user and the blocking member <NUM>.

In some embodiments, the cover member <NUM> includes a holding formation (not shown) and the blocking member <NUM> includes a corresponding formation <NUM>. When the holding formation engages the corresponding formation <NUM> the cover member <NUM> is held in its closed position (over the end of the blocking member <NUM> and sealing the outlet <NUM> in order to prevent or at least inhibit drips of liquid from exiting the outlet <NUM>).

In some embodiments, the cover member <NUM> may be biased to its open position. In other words, once the holding formation and the corresponding formation <NUM> are disengaged from each other the cover member <NUM> may automatically move away from the outlet <NUM>.

In some embodiments, the cover member <NUM> is moved due to movement of another part of the valve <NUM>. In an example, as the blocking member <NUM> is moved towards its open position, the blocking member <NUM> effects movement of the cover member <NUM> to its open position. In such embodiments, the cover member <NUM> may have no biasing or may be biased towards a closed position (such that opening of the blocking member <NUM> controls the opening of the cover member <NUM>).

The cover member <NUM> is attached to the body <NUM>. In some embodiments, the cover member <NUM> includes a resiliently biased and flexible connection portion that extends to form the connection / attachment to the body <NUM>.

Use of the valve <NUM> will now be discussed with reference to the features that have already been outlined above. In the closed position, the blocking member <NUM> blocks the inlet <NUM>, such that fluid cannot flow through the valve <NUM>. More specifically, when the valve <NUM> is in a closed position, the blocking portion <NUM> is positioned in the body passage <NUM> and closes off (i.e. seals) the inlet <NUM> (and liquid cannot flow through the inlet <NUM> and into the valve <NUM>).

In the open position, the inlet <NUM> is open, such that fluid is permitted to pass through the valve <NUM>. More specifically, when the valve <NUM> is in the open position, the blocking portion <NUM> is moved to an "outer" position, the inlet <NUM> communicates with the opening through the blocking member <NUM>. In this configuration, liquid is permitted to exit the valve <NUM> via the outlet <NUM>. It should be appreciated that such an "open" position refers to a fully open position in which the inlet <NUM> is open to its fullest extent (so the blocking portion <NUM> blocks the inlet <NUM> to the least extent possible) to allow a maximum flow rate of liquid to flow through the valve.

There is a range of partially open positions in which the blocking member <NUM> can be positioned which will result in a different flow rate of liquid being permitted to flow through the inlet <NUM> (due to it being partially open) and, thus, through the valve <NUM>. In other words, the inlet <NUM> has a (total) cross-sectional area that is dictated by its size and shape. The inlet <NUM> also has an "available cross-sectional area" which is the available area (during use) through which liquid may flow. While the total cross-sectional area of the inlet <NUM> will not change substantially (it may change slightly through use of the valve <NUM> and general wear), the size of the available cross-sectional area depends on the position of the blocking member <NUM> (until the blocking member <NUM> reaches the fully open position and the entirety of the inlet <NUM> is open and available for liquid to flow through).

The inlet <NUM> is shaped such that as the blocking member is moved between a position in which a flow path is initially opened and a fully open position, the rate of change of the permitted flow rate of liquid permitted through the valve <NUM> increases with non-linear proportionality as the blocking member <NUM> is moved (although it should be appreciated that the rate of change of the permitted flow rate of the liquid through the inlet <NUM> may have both linearly proportional and non-linearly proportional portions). In other words, when considering the increase of the available cross-sectional area of the inlet <NUM> as the blocking member <NUM> is moved from initially open to fully open, the increase is non-linear.

For example, when the blocking member <NUM> is positioned at a distance x from its closed position, the available cross-sectional area is defined by a function (f(x)). When the blocking member <NUM> is positioned at a distance 2x from its closed position, the available cross-sectional area is defined by the same function (f(2x)). In this example, f(2x)> 2f(x) (i.e. as the blocking member <NUM> is moved towards its open position from an initially open position, each unit of movement results in a small change in the available cross-sectional area of the inlet <NUM> and as the blocking member moves further the change in the available cross-sectional area becomes larger and larger until the fully open position).

In the present example, the inlet <NUM> is narrowed at one and becomes wider at an opposing end. The inlet <NUM> is oriented so that the narrower part becomes open first (as the blocking portion <NUM> moves outwards along the channel <NUM>). As the blocking portion <NUM> moves further outwards, the wider parts of the inlet <NUM> become open. Thus, in this example the rate of change of the flow rate through the valve <NUM> will increase faster than it would for a rectangular or square inlet. In some embodiments, the inlet <NUM> has curved corners, which results in a different non-linear change in the flow rate.

The advantage of the inlet <NUM> being shaped in such a way that the flow rate of the liquid through the valve <NUM> is initially low and then increases more quickly (relative to a rectangular inlet <NUM>, for example) is that a user can more easily control the direction of liquid flow when only a small amount of liquid is permitted to exit the valve <NUM>. Once the user has established that the direction, etc. of the flow is acceptable they can continue to move the blocking member <NUM> towards its fully open position (which is reached more quickly due to the shape of the inlet <NUM>). Thus, a valve <NUM> that has a low liquid flow rate initially (where the blocking member <NUM> is positioned at a distance x) and increases more quickly due to a wider part of the inlet <NUM> (where the blocking member is positioned at a distance that is greater than x) is an advantageous arrangement.

The functions that dictated the available cross-sectional area of different shaped inlets are illustrated generally in figures 10a, b and c. A rectangular shape is illustrated in 10a, and as can been seen the increase in available cross-sectional area is linearly proportional with the distance x that the blocking member <NUM> has travelled. A trapezoidal shape is illustrated in figure 10b. As can be seen the flow rate/available cross-sectional area is small to start with and the increase is steep as the distance x the blocking member <NUM> moves is increased. This results in a slow flow rate initially (to provide an aid for the user) and then approaching the largest flow rate fast as the blocking member <NUM> is moved further. Thus, the increase in flow rate is proportional to the distance x that the blocking member <NUM> has moved (but is not linearly proportional).

<FIG> illustrates a circular shape, which results in a slow increase in the available cross-sectional area initially, then a steep increase as the widest part of the circle is available, followed by a slowing of the increase of the available cross-sectional area at the fully open position.

In the illustrated example, the blocking member <NUM> "opens" the flow path for liquid through linear movement with respect to the body <NUM>. It should be appreciated that the desired alteration of the flow rate could be achieved using a valve that includes a portion that rotates between its closed position and its open position (and vice versa). The inlet may be positioned on the rotating part and the available cross-sectional area may be increased / decreased as the rotating part rotates. In this case the "distance" that the rotating portion travels through is an arc rather than linear.

Before the valve <NUM> is opened to allow waste to flow out of the urostomy appliance <NUM>, the user may connect a conduit or tube <NUM> to the valve <NUM>, so that the waste flowing out of the urostomy appliance <NUM> flows into another, connected, receptacle. The receptacle could be a night drainage bag, for example, so that the user does not have to get up during the night to empty their urostomy appliance <NUM> as it is connected to another (bigger) volume.

Thus, a drainage system is provided by the combination of the urostomy appliance <NUM> (described above), valve <NUM> and a connector <NUM> that is connectable to the conduit <NUM>. Features of the valve <NUM> that permit the connector <NUM> to connect to the valve <NUM> are described below. However, it should be appreciated that another urostomy appliance/valve combination could connect to the connector <NUM> as long as the valve provided the features outlined here in relation to connecting to the connector <NUM>.

The valve <NUM> includes the outlet <NUM> that forms a first fitting having a recess and an internal surface 16a. In some embodiments, the first fitting includes a hollow cylinder, which provides at least part of a flow path out of the valve <NUM> and into/through the connector <NUM>.

In some embodiments, the first fitting has a circumferentially extending flange portion <NUM> at or near an entrance to its recess which provides an end face. The flange portion <NUM> extends generally perpendicularly to an axis A that extends longitudinally through the valve <NUM>.

An embodiment of the connector <NUM> is illustrated in <FIG>. The connector <NUM> is connected or connectable at a first end to a conduit <NUM> (the conduit <NUM> may be connected by way of a spigot or push fit fitting <NUM>, for example). The connector <NUM> is connected or connectable at a second end to the valve <NUM>. The second end provides a second fitting including a projection <NUM> having an external surface 106a. In other words, the connector <NUM> has a main body <NUM> that extends between the first and second ends.

In some embodiments, the second fitting includes a hollow cylinder, which, in use, provides at least part of a flow path through the connector <NUM> to the connected conduit <NUM>. In some embodiments, the second fitting has a circumferentially extending shoulder <NUM> that is spaced from its distal end 106b. The shoulder <NUM> extends generally perpendicularly to an axis B that extends longitudinally through the connector <NUM> (although it should be appreciated that this need not be the case as the shoulder may be angled other than at <NUM> degrees, e.g. generally transversely, to axis B and still provide its function).

In some embodiments, the connector <NUM> includes two holding formations <NUM> (although it should be appreciated that there may be more or fewer holding formations <NUM>, as desired). The holding formations <NUM> are positioned on opposing sides of the main body <NUM> to each other (in the case of more than two holding formations, they may be spaced around the main body and in the case of one holding formation, it may be positioned to one side). Each holding formation <NUM> includes an elongate portion 110a that is attached to the main body <NUM> by an extension portion <NUM>0b. The elongate portion 110a extends generally parallel to the axis B and the extension portion 110b extends generally perpendicular to the axis B (away from the main body <NUM>). The extension portion 110a connects to the main body <NUM> further away from the connector's distal end 106b than the shoulder <NUM>. The elongate portion 110a extends beyond the shoulder <NUM>, towards the distal end 106b, and overlies the second fitting (and, when connected to the valve <NUM>, overlies the flange portion <NUM>). The extension portion 110b connects the elongate portion 110a to the main body <NUM> with a degree of flexibility so as to provide a pivoting action that allows the elongate portion 110a to move out of general parallel alignment with the main body <NUM> / axis B.

The elongate portion 110a includes a camming surface 110c. In the illustrated case, the camming surface 110c is positioned at one end of the elongate portion 110a, which is closest to the shoulder <NUM> (it should be appreciated that there are other arrangements that provide the same functionality). The camming surface 110c faces inwardly, towards the main body <NUM> / second fitting. This allows the camming surface 110c to engage the flange portion <NUM> during use (described in more detail below).

The holding formation <NUM> or at least a part of the holding formation <NUM> is resiliently biased, so that it may be moved and/or deflected and return to its original position. In the present embodiment, the extension portion 110b provides a pivoting action that allows the elongate portion 110a to deflect outwards. However, it should be appreciated that the holding formation <NUM> in general is made of a plastics material that is resilient and, therefore, the elongate portion 110a is also able to deform in itself as well as in combination with the extension portion 110b. Thus, it should be appreciated that the extension portion 110b does not necessarily need to provide such a pivoting action in order for the holding formation <NUM> to function (i.e. hold the connector <NUM> to the valve <NUM>).

In some embodiments, the second fitting includes a seal <NUM>, which is provided on, connected to or forms part of the external surface 106a. The seal <NUM> is located in a position between the shoulder <NUM> and the distal end. In this illustrated case, the seal <NUM> extends continuously and in an annular shape in a plane that is perpendicular to axis B (but this may not be the case). In some embodiments, the seal <NUM> is formed using an overmoulding process.

In use, the second fitting (of the connector <NUM>) is received in the first fitting (of the valve <NUM>) when the connector <NUM> is connected to the valve <NUM>. When the connector <NUM> is connected to the valve <NUM>, the shoulder <NUM> engages the end face of the female fitting. Advantageously, the holding formations <NUM> engage the flange portion <NUM> such that the connector <NUM> and the valve <NUM> are held together and disconnection is inhibited or substantially prevented.

As the connector <NUM> is moved towards a "connected position", the respective camming surfaces 110a of the holding formations <NUM> are (automatically) deflected outwards over the flange portion <NUM>. It should be appreciated that if camming surfaces 110a are not provided then a latch formed from a projection maybe present and a user can manually deflect the holding formations <NUM> over the flange portion <NUM>. Advantageously, if the holding formation <NUM> is resiliently biased, it moves back to its original position once the camming surfaces have moved past the flange portion <NUM>.

Also when the connector <NUM> is connected to the valve <NUM>, the seal <NUM> engages the internal surface 16a of the first fitting. Thus, liquid leakage around the first / second fittings is minimised / inhibited / substantially prevented.

To disconnect the connector <NUM> from the valve <NUM>, the opposite end of the elongate portion 110a to the camming surface 110c is pressed towards the main body <NUM>, so as to deflect the latch / camming surface 110c over the flange portion <NUM> (and the connector <NUM> can be disconnected from the outlet <NUM> of the valve <NUM>).

Claim 1:
A valve (<NUM>) for a urostomy appliance (<NUM>) including:
a body (<NUM>) for connection to the urostomy appliance (<NUM>),
an inlet (<NUM>) and an outlet (<NUM>), connected by a flow path, and
a blocking member (<NUM>) supported by the body (<NUM>) and generally moveable between a closed position, in which the blocking member (<NUM>) blocks the inlet (<NUM>), such that liquid cannot flow through the flow path to the outlet (<NUM>), and an open position in which the inlet (<NUM>) is open, such that liquid is permitted to flow through the flow path to the outlet (<NUM>), and
a cover member (<NUM>) which is moveable between an open position, in which liquid is permitted to flow through the outlet (<NUM>), and a closed position, in which liquid is prevented or inhibited from flowing through the outlet (<NUM>), and wherein the cover member (<NUM>) is biased towards its open position, and
wherein the cover member (<NUM>) includes a holding formation and the blocking member (<NUM>) includes a corresponding formation (<NUM>), such that when the holding formation engages the corresponding formation (<NUM>) the cover member (<NUM>) is held in its closed position characterised in that the blocking member is generally linearly moveable between the open position and closed position.