Patent Description:
Urostomy appliances are well known in the field. They are typically attached to a patient by an adhesive wafer which extends around the patient's stoma with adhesive and provide a collecting chamber to collect 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 valve apparatus that includes a housing having proximal and distal ends and defining a passageway between. An access port of the housing defines a bore configured for selective communication with the passageway. <CIT> discloses a spring-loaded bag connector having a spring-loaded valve and a housing comprising a fluid inlet portion and a fluid outlet portion.

In accordance with an aspect of the present invention we provide a valve for a urostomy appliance including: a housing for connection to the urostomy appliance, the housing having an inlet and an outlet, wherein the housing includes a housing passage extending between the inlet and outlet, and a body which is received in the housing passage and which is rotatable about an axis between an open position, in which liquid is permitted to flow to the outlet, and a closed position, in which liquid is substantially prevented from flowing to the outlet, wherein the body is received in the opening in the housing and has a body passage extending from a body inlet to a body outlet, wherein when the body is in its open position the body outlet at least partially aligns with the housing outlet and permits liquid to pass through the body passage and flow through the housing outlet, and wherein the valve includes a sealing device which extends around a periphery of the body between the body and the housing passage and which extends around the body outlet, such that the sealing device prevents ingress of liquid between the body and the housing passage when the body is in its closed position.

Further aspects of the present invention are provided in the appended claims <NUM> to <NUM>.

Embodiments of the invention will now be described with reference to the accompanying figures, of which:.

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>.

Features of the valve <NUM> are shown in more detail in <FIG>. The valve <NUM> includes a housing <NUM> which connects to the urostomy appliance <NUM>, and a body <NUM>, which is supported in the housing <NUM>. The housing <NUM> has an inlet <NUM>, an outlet <NUM> and a housing passage <NUM>. A liquid flow path extends between the inlet <NUM> and the outlet <NUM>, through at least a part of the housing passage <NUM> (see flow path "B" illustrated in 7B, particularly).

In the illustrated embodiment (see especially <FIG>), the housing <NUM> also includes a planar member <NUM> and a cylindrical portion <NUM>. The planar member <NUM> forms the part of the housing <NUM> that connects to the second wall 2b. The inlet <NUM> is defined in the planar member <NUM>. An aperture (not shown) in the second wall 2b corresponds with the inlet <NUM> of the housing <NUM> (which provides a path for waste between the waste collecting cavity <NUM> and the valve <NUM>).

In the present example, the housing <NUM> attaches to the second wall 2b by a heat weld which seals the wall 2b to the planar member <NUM>. It should be appreciated that the housing <NUM> may be attached to the urostomy appliance <NUM> by another means, so long as the housing <NUM> is sealed to the urostomy appliance <NUM>, so that liquid cannot exit the appliance <NUM> (in normal use) without using the valve <NUM>.

In this example, the cylindrical portion <NUM> defines the housing passage <NUM>. However, it should be appreciated that this exact configuration is not essential.

The body <NUM> is received in the housing passage <NUM> and is rotatable between an open position (shown in <FIG> and <FIG>) and a closed position (shown in <FIG> and <FIG>). In the open position, liquid can flow through the valve <NUM>. In this example, this includes the waste liquid flowing out of a waste collecting cavity <NUM> via the aperture in the second wall 2b and the inlet <NUM> of the valve <NUM> and out of the outlet <NUM>. In the closed position, liquid is prevented from flowing through the valve <NUM> (therefore, the waste is stored in the waste collecting cavity <NUM>).

The body <NUM> has a blocking portion <NUM> and defines a body inlet and a body outlet <NUM> (and a body passage extending from the body inlet to the body outlet <NUM>). In the illustrated example, the body <NUM> has a wall which forms a substantially cylindrical part <NUM> and the body outlet <NUM> is defined through the wall of the cylindrical part <NUM>.

The body <NUM> also has a user operable portion <NUM> for effecting rotation of the body. The cylindrical part <NUM> is received in the cylindrical portion <NUM> / housing passage <NUM> of the housing <NUM>.

In more detail, in the open position, the body outlet <NUM> at least partially aligns with the outlet <NUM> and permits liquid to flow through the outlet <NUM>. In the closed position, the blocking portion <NUM> aligns with the outlet <NUM> and liquid is substantially prevented / inhibited from exiting through the outlet <NUM>. In other words, the body outlet <NUM> opens the flow path through the valve <NUM> and the blocking portion <NUM> closes the flow path through the valve <NUM>, and the position of the blocking portion <NUM> and body outlet <NUM> depends on the rotational position of the body <NUM> relative to the housing <NUM>.

The body <NUM> rotates between its open and closed position about an axis of rotation (illustrated by the line referenced "A" in the <FIG>). The axis "A" extends substantially centrally through the body <NUM> and the housing passage <NUM> (i.e. the cylindrical portion <NUM> of the housing <NUM> that defines the housing passage <NUM>).

The valve <NUM> also includes an engagement device which prevents or at least inhibits the body <NUM> from being removed from the passage <NUM> during rotation of the body <NUM>. The engagement device includes a first and a second formation <NUM>, <NUM>. The first formation <NUM> is provided on or by the body <NUM> and extends, at least partially, around the body. The second formation <NUM> is located outside an entrance to the passage <NUM> and engages with the first formation <NUM> (when the valve <NUM> is assembled).

The first formation <NUM> is positioned in a plane which is substantially transverse to the axis. In some embodiments, the first formation <NUM> extends at least half way around a circumference of the body <NUM> (and, in an example extends completely around the circumference of the body <NUM>).

In the illustrated embodiment, the first formation <NUM> includes a ridge or a rim which projects from an outer surface of the body <NUM>. As can be seen from the figures, the projection in this example extends continuously around the outer surface of the body <NUM>. It should be appreciated that the projection / first formation <NUM> need not extend continuously and such an embodiment is described further below.

The second formation <NUM> extends transverse to the axis of rotation of the body <NUM>. The second formation <NUM> is substantially elongate and, in the present example, includes a recess/groove or an aperture.

The second formation <NUM> (in this example, an elongate aperture) is formed in the planar member <NUM> of the housing <NUM> (adjacent to the entrance to the passage <NUM>). The first formation <NUM> (in the illustrated example, a projection) is received in the second formation when the body <NUM> is in an operating position in the passage of the housing <NUM> (i.e. in the configuration in which liquid is inhibited from exiting through the valve <NUM> when the valve <NUM> is closed).

In some embodiments, the first formation <NUM> may include multiple projections which are spaced apart from each other around the outer surface of the body <NUM>. In order to ensure the engagement device fulfils its function of inhibiting the body <NUM> being removed from the housing <NUM> when the body <NUM> is rotated, the projections are spaced at an appropriate distance so that as one projection exits an end of the recess or aperture of the second formation <NUM> (when the body <NUM> rotates), another projection enters the recess at an opposing end. In other words, at least one projection is always received in the recess at all times/at all body positions.

In some embodiments, the plane in which the first formation <NUM> is positioned also passes through user operable portion <NUM> (refer to the figures, for example). The first formation <NUM> may extend completely around the body <NUM> except for the peripheral space which is occupied by the user operable portion <NUM>. In other words, the first formation <NUM> extends completely around the circumference of the body <NUM> and has a first end which is connected to one side of the user operable portion <NUM> and an opposite second end which is connected to a second side of the user operable portion <NUM>.

The valve <NUM> is assembled by inserting the body <NUM> into the passage <NUM> of the housing <NUM>. The body <NUM> is pushed into the housing <NUM> until the first formation <NUM> is positioned in / engages with the second formation <NUM> on the housing <NUM>. Once the first formation <NUM> is held in the second formation <NUM>, the valve <NUM> is in an "operational positon" - i.e. the body <NUM> may be rotated in the housing <NUM> between the above described open and closed position in order to permit or block liquid from exiting through the outlet <NUM> of the housing <NUM> and the engagement device prevents the body <NUM> becoming detached from the housing <NUM>.

There are multiple features that may be provided alone or in combination with each other to aid assembly of the valve <NUM>. In some embodiments, the planar member <NUM> includes a camming surface which leads to the second formation <NUM> and engages the first formation <NUM> as the body <NUM> is inserted into the passage <NUM>. In other words, the camming surface aids assembly because the body <NUM> is subject to a gradually increasing force as the first formation <NUM> is moved along the camming surface. In some embodiments, the camming surface is positioned at or near a periphery of the planar member <NUM> (and between an edge of the planar member <NUM> and the second formation <NUM>).

In some embodiments, the planar member <NUM> is made from a relatively more flexible material than other parts of the housing <NUM> / body <NUM>. This allows a degree of "flexing" as the body <NUM> is moved into position (e.g. its operable position in which the first formation <NUM> engages the second formation <NUM>). In this case, the planar member <NUM> flexes "away" from the first formation <NUM> as the body <NUM> is moved towards its position in the second formation <NUM>. In other words, the planar member <NUM> becomes more convex on its top surface, temporarily, to aid movement of the body <NUM> (and the first formation <NUM>) into position and then returns to its normal shape (i.e. a flatter shape) once the first formation <NUM> is received by the second formation <NUM> (and the body <NUM> is held in place relative to the housing <NUM>).

In the embodiment illustrated in <FIG>, the valve <NUM> has the features that are described in relation to the other figures (some of which are labelled explicitly to aid the explanation included below). It should be appreciated, that any embodiment could include any combination of one or more optional features described.

In the case of the valve <NUM> in <FIG>, the planar member <NUM> includes two slits <NUM>, one of which is located on each opposing side of the second formation <NUM> (i.e. each slit <NUM> is positioned adjacent the second formation <NUM>). In other words, part of the planar member <NUM> forms of three portions that are separated by elongate openings that extend inwards from the periphery of the planar member <NUM> - the second formation <NUM> is positioned on the central portion (of the three portions) between the two openings.

The slits <NUM> extend parallel to each other and extend inwardly from the periphery of the planer member <NUM> (although it should be appreciated that the slits could extend at an angle to one another and provide similar functionality). The slits <NUM> allow a portion of the planar member <NUM> to flex/move as the body <NUM> is moved into its operable position (where the first and second formations <NUM>, <NUM> engage) relative to the remaining parts of the planar member <NUM>. In other words, the portion of the planar member <NUM>, between the slits <NUM>, is able to deform out of position (and out of alignment with the rest of the planar member <NUM>), so that moving the body <NUM> into operational position is easier. The planar member <NUM> moves back to its original position once the first and second formations <NUM>, <NUM> engage. It should be appreciated that the slits <NUM> do not necessarily have to extend through all of the material of the planar member <NUM>. Alternatively, a single or pair or more groove(s) could be provided that also permit the planar member to deflect / distort from its resting position and aids assembly of the valve <NUM>.

It should be appreciated that, in some embodiments, there may be a single slit positioned in a location so as to allow a portion of the planar member <NUM> to distort as the body <NUM> is moved towards its operational position.

Additionally, it should be appreciated that the slit(s) described above may be combined with one or more of the other features described above. For example, a camming surface maybe provided on the planar member and/or the slit(s) and/or manufacturing from a relatively more flexible material in any combination, as desired.

The body <NUM> further includes a sealing device <NUM> which extends around a periphery of the body <NUM>, between the body <NUM> and the housing passage <NUM>, and the sealing device <NUM> also extends around the body outlet <NUM> so that the sealing device <NUM> prevents the ingress of liquid between the body <NUM> and the housing <NUM> when the body <NUM> is in the closed position. The wording "around" is intended to define the sealing device <NUM> extending in a plane generally transverse to the rotation axis.

In some embodiments (for example, those illustrated in the figures), the sealing device <NUM> is on the body <NUM>. In other words, the body <NUM> supports the sealing device <NUM>. This is advantageous because it allows the sealing device <NUM> to provide the required sealing around the body outlet <NUM> to prevent liquid ingress between the body <NUM> and the housing <NUM> (even when the body <NUM> is rotated to a different position).

The sealing device <NUM> includes two generally parallel annuli 50a which extend around the body <NUM> and are spaced apart from another on opposing axial sides of the body outlet <NUM>. There are two further joining portions 50b which extend from one annulus 50a to the other, on either side of the body outlet <NUM>. In this way two sealing rings around the periphery of the body <NUM> are provided and a seal surrounding the body outlet <NUM> also.

A surface of the sealing device <NUM> that faces outwards from the body <NUM> may be substantially convex or curved.

In some embodiments, the sealing device <NUM> includes two support portions <NUM> (each of which includes a relatively thicker portion of material). Each support portion <NUM> is positioned approximately mid-way between the parallel annuli 50a and connects to one of the joining portions 50b. Each support portion <NUM> helps reduce distortion of the sealing device <NUM>. Over time, as the valve <NUM> is used and the body <NUM> is repeatedly rotated in the housing <NUM> a distorting force will be exerted on the edges of the sealing device <NUM> (particularly parts of the sealing device <NUM> that surround the body outlet <NUM>) which may bend the sealing device <NUM> out of shape and/or out of position. In some circumstances, this could result in the sealing device <NUM> failing and allowing liquid through the valve <NUM> even when the body <NUM> is in its closed position. The support portions <NUM> are more rigid than other parts of the sealing device <NUM> (by virtue of their relative thickness) and, thus, reinforce the sealing device <NUM>. It should be appreciated that the sealing device <NUM> may include more or fewer support portions <NUM>, as desired.

In some embodiments, a retention device which aids retention of the sealing device <NUM> in a correct location with respect to the body <NUM> is present. The retention device includes, in this example, six recesses <NUM> which are generally circle shaped and formed in the body <NUM> and six corresponding projections <NUM> (in this case, the projections are also generally circle shaped) which project inwardly from an inner surface of the sealing device <NUM>. When the sealing device <NUM> is in position on the body <NUM>, the projections <NUM> engage the recesses <NUM>. This provides anchorage to help keep the sealing device <NUM> in the correct position.

It should be appreciated that although there are six recesses <NUM> and six projections <NUM> in the illustrated example, this need not be the case. There may be, in some embodiments, one or more recesses, which engage the same number of projections and they may be differently shaped, e.g. square, oval or hexagonal. In other words, at least one recess and projection correspond to one another such that they can function to provide anchoring of the sealing device <NUM> in position relative to the body <NUM>.

In some embodiments, the sealing device <NUM> is manufactured in position relative to the body <NUM> by using an overmoulding process. The sealing device <NUM> is made with a thermoplastic elastomer / thermoplastic rubber material (although other suitable materials could be used). It is important that the material is capable of distorting such that when it presses between the body <NUM> and the housing <NUM>, it can provide the necessary sealing.

The housing <NUM> is made from a High Density Polyethylene (HOPE) resin. Such a material provides toughness, rigidity and strength to the housing <NUM>. The body <NUM> is made from a polypropylene homopolymer (as such, the body <NUM> has low warpage and high stiffness in combination with moderate impact strength at room temperature).

In use, the waste collecting cavity <NUM> collects waste (e.g. urine and/or other body fluid) which enters the urostomy appliance <NUM> via the stoma opening <NUM>. The valve <NUM> is attached to the second wall 2b of the urostomy appliance <NUM>, so that the user can select when they wish to empty the waste collecting cavity <NUM>.

While the valve <NUM> is in the closed position, the blocking portion <NUM> seals the flow path to the outlet <NUM> of the housing <NUM> (as illustrated in <FIG>). To open the valve, the user uses the user operable portion <NUM> to rotate the body <NUM> within the housing <NUM> (about axis "A").

To open / close the valve <NUM>, the body <NUM> is rotated between first and second positions (the relative alignments of the outlets is discussed in detail below). In this example, the body <NUM> is held and/or maintained in a single axial position relative to the housing <NUM> (i.e. the body <NUM> does not enter the housing <NUM> further, nor does it move out of the housing <NUM> at all). In the illustrated example, the first formation <NUM> is held in a single axial position by the second formation <NUM>. In other words, the first formation <NUM> is permitted to rotate in / through the second formation <NUM>, so that the body <NUM> remains held in a single axial position (along axis "A") relative to the housing <NUM>.

In the open position, the body <NUM> is in a positon in which the body outlet <NUM> aligns with the outlet <NUM> of the housing and, thus, liquid is permitted to flow out of the valve <NUM> (this is shown in <FIG>). The flow path "B" created when the valve <NUM> is in the open position is illustrated in <FIG>.

In the closed position (illustrated in <FIG>), the body <NUM> is in a position in which the body outlet <NUM> is out of alignment with the outlet <NUM> of the housing <NUM>. In this example, the wall of the housing <NUM> provides the blocking portion <NUM> which blocks the housing outlet <NUM> and prevents or at least inhibits liquid flow out of the body outlet <NUM> (and the housing outlet <NUM>). In other words, while the body outlet <NUM> is out of alignment with the housing outlet <NUM>, the wall of the body <NUM> is in alignment with the housing outlet <NUM>, so as to block the flow of fluid through the valve <NUM>.

In summary, the body <NUM> is rotated between open and closed positions and, in the open position the body outlet <NUM> aligns with the housing outlet <NUM> (and the blocking portion <NUM> is out of alignment with the housing outlet <NUM>), and in the closed position the body outlet <NUM> is out of alignment with the housing outlet <NUM> (and the blocking portion <NUM> is in alignment with the housing outlet <NUM>).

In the illustrated embodiment, the distance between the valve <NUM> being in a fully closed position (i.e. where the blocking portion <NUM> is centred across an opening which leads to the outlet <NUM> and "completely" blocking the liquid flow) and the fully open position (i.e. where the body outlet <NUM> aligns with the opening which leads to the outlet <NUM> and the flow path is "completely" open) is a half turn or around <NUM> degrees. It should be appreciated that the open position may not be the fully open position as the flow path may still be open when the body <NUM> has completed a smaller rotation (e.g. around <NUM> degrees).

However, the maximum flow rate of liquid from the urostomy appliance <NUM> will be lower because the flow path is narrower.

The valve <NUM> is closed (and sealed to prevent or at least inhibit liquid exit from the valve <NUM>) via a rotational movement of the body <NUM> relative to the housing <NUM>, so as to bring the sealing device <NUM>, into complete contact with an interior surface of the housing <NUM> (which blocks the liquid flow path between the body inlet and outlet <NUM> and the housing outlet <NUM>). As discussed above, the sealing device <NUM> is located around the body outlet <NUM> and seals against the housing <NUM> to prevent (or at least inhibit) liquid flow.

The valve <NUM> is opened (which allows liquid to flow through the valve <NUM>) via a rotational movement of the body <NUM> relative to the housing <NUM>, so as to open the liquid flow path through the body outlet <NUM>.

Claim 1:
A valve (<NUM>) for a urostomy appliance (<NUM>) including:
a housing (<NUM>) for connection to the urostomy appliance (<NUM>), the housing (<NUM>) having an inlet (<NUM>) and an outlet (<NUM>), wherein the housing (<NUM>) includes a housing passage (<NUM>) extending between the inlet (<NUM>) and outlet (<NUM>), and
a body (<NUM>) which is received in the housing passage (<NUM>) and which is rotatable about an axis between an open position, in which liquid is permitted to flow to the outlet (<NUM>), and a closed position, in which liquid is substantially prevented from flowing to the outlet (<NUM>), wherein the body (<NUM>) is received in the opening in the housing (<NUM>) and has a body passage extending from a body inlet to a body outlet (<NUM>),
wherein when the body (<NUM>) is in its open position the body outlet (<NUM>) at least partially aligns with the housing outlet (<NUM>) and permits liquid to pass through the body passage and flow through the housing outlet (<NUM>), and
wherein the valve (<NUM>) includes a sealing device (<NUM>) which extends around a periphery of the body (<NUM>) between the body and the housing passage (<NUM>) and which extends around the body outlet (<NUM>), such that the sealing device (<NUM>) prevents ingress of liquid between the body (<NUM>) and the housing passage (<NUM>) when the body (<NUM>) is in its closed position.