WO2022129954A1

WO2022129954A1 - Urostomy bag outlet

Info

Publication number: WO2022129954A1
Application number: PCT/GB2021/053375
Authority: WO
Inventors: Nicholas GOSWELL; Ross Murphy; Chris Bray
Original assignee: Welland Medical Limited
Priority date: 2020-12-18
Filing date: 2021-12-20
Publication date: 2022-06-23
Also published as: EP4262640A1; GB2602103A; GB202020086D0

Abstract

An outlet for a urostomy appliance has a valve comprising a housing, a valve stem and a plug. The plug is fixed in position relative to the housing. The valve stem defines a channel between a first opening and a second opening, the channel being parallel with a longitudinal axis of the outlet and defining a seat for the plug. The housing surrounds the valve stem and is configured to be movable together with the plug relative to the valve stem parallel with the longitudinal axis of the outlet between a first position wherein the plug abuts the seat thereby closing the channel and a second position wherein the plug does not abut the seat thereby opening the channel. The outlet has particular application in urostomy appliances, in particular for users having limited dexterity.

Description

Urostomy Bag Outlet

The present invention relates to an outlet for a urostomy appliance having a valve. The outlet has particular application in urostomy appliances, in particular for users having limited dexterity.

Background of the Invention

A urostomy appliance is typically connected to a stoma on the abdomen of a user and collects urine expelled through the stoma into a bag. Known urostomy appliances include a bag which has an outlet which is generally closed, but which can be opened in order to drain the bag into a toilet so that the bag can be refilled with urine from the stoma. At night, a tube for an additional collection bag may be connected to the outlet so that if a first bag is filled, additional capacity is provided and draining is not required until morning.

The outlet of some known urostomy appliances is formed of a soft material defining an aperture and a resilient 'bung' style plug is placed in the aperture to prevent the flow of urine. One end of a collection bag tube can be pressed into the aperture and held in place by a barbed component on the end of the tube.

Alternatively, other known urostomy appliances have an outlet formed of a rigid material defining an aperture and having a valve that is turned radially relative to the direction of flow through the valve in order to open and close the aperture. These ostomy appliances require an additional adapter in order to provide a suitable interface between their outlet and a night collection bag tube.

The soft style outlet is typically preferred for comfort, whereas a hard twist style outlet is preferred for improved usability for users having limited dexterity. There is a requirement for a urostomy bag outlet that is comfortable for a user, has improved usability and does not require an additional adapter to connect to a night collection bag.

In light of the problems discussed above, various proposals have been made, but there remains a need for an improved device which address one or more of the problems presented by prior art arrangements. In this regard, the present invention aims to provide a novel device which allows a better, more consistent and predictable performance. In addition, the present invention seeks to provide an alternative device which preferably addresses one or more of the problems presented by prior art arrangements.

Summary of the Invention

In accordance with a first aspect of the present invention there is provided an outlet for a urostomy appliance having a valve comprising a housing, a valve stem and a plug, wherein the plug is fixed in position relative to the housing, the valve stem defines a channel between a first opening and a second opening, the channel being parallel with a longitudinal axis of the outlet, wherein the channel defines a seat for the plug, the housing surrounds the valve stem and is configured to be movable together with the plug relative to the valve stem parallel with the longitudinal axis of the outlet between a first position wherein the plug abuts the seat thereby closing the channel and a second position wherein the plug does not abut the seat thereby opening the channel.

Preferably, in a first embodiment, at least one projection extends from the housing and the projection is capable of travelling in a helical groove in the valve stem. Alternatively, at least one projection extends from the valve stem which is capable of travelling in a helical groove in the housing.

In this embodiment, the housing surrounds the valve stem and is configured to be movable together with the plug relative to the valve stem so that as the projection travels in the helical groove, the housing and the plug rotate relative to the valve stem and also move relative to the valve stem parallel with the longitudinal axis of the outlet.

Advantageously, the change in the position of the housing relative to the position of the valve stem provides a useful indicator to a user, indicating whether the outlet is open (for drainage, or for when connected to a night drainage bag), or is safely closed.

Preferably, the helical groove has first and second ends, which limit rotation of the housing and the plug relative to the valve stem. When the projection abuts the first end or the second end of the groove, further rotation and axial movement of the housing and the plug relative to the valve stem is prevented.

Preferably, two helical grooves are provided. Preferably, the two helical grooves are arranged diametrically opposite each other. Preferably, two projections extend from opposite sides of the housing each of which are capable of travelling in a helical groove in the valve stem. Alternatively, two projections extend from opposite sides of the valve stem each of which are capable of travelling in a helical groove in the housing. Alternatively, a projection extends from a side of the housing which is capable of travelling in a helical groove in the valve stem and a projection extends from a side of the valve stem which is capable of travelling in a helical groove in the housing.

Alternatively, a plurality of helical grooves is provided. Preferably, the plurality of helical grooves is arranged so that the grooves are diametrically equidistant from each other. Preferably, a plurality of projections extends from the housing diametrically equidistant from each other and each projection is capable of travelling in a helical groove in the valve stem. Alternatively, a plurality of projections extend from a side of the valve stem diametrically equidistant from each other and each projection is capable of travelling in a helical groove in the housing.

Preferably, in a second embodiment, the housing and the plug are configured to be movable relative to the valve stem only linearly and parallel with the longitudinal axis of the outlet. In this embodiment, preferably, the housing and the plug are configured to allow no rotation of the housing and the plug relative to the valve stem.

In this embodiment, the housing surrounds the valve stem and is configured to be movable together with the plug relative to the valve stem so that as the projection travels in a linear straight groove, the housing and the plug move relative to the valve stem only parallel with the longitudinal axis of the outlet.

One advantage of the housing moving in only a linear straight motion, is that when a user needs to open the outlet valve, they can aim the outlet valve towards a toilet bowl and pull the housing away from themselves to open the outlet valve keeping a neutral grip and wrist position.

Preferably, two linear grooves are provided. Preferably, the two linear grooves are arranged diametrically opposite each other. Preferably, two projections extend from opposite sides of the housing each of which are capable of travelling in a linear groove in the valve stem. Alternatively, two projections extend from opposite sides of the valve stem each of which are capable of travelling in a linear groove in the housing. Alternatively, a projection extends from a side of the housing which is capable of travelling in a linear groove in the valve stem and a projection extends from a side of the valve stem which is capable of travelling in a linear groove in the housing.

Alternatively, a plurality of linear grooves is provided. Preferably, the plurality of linear grooves is arranged so that the grooves are diametrically equidistant from each other. Preferably, a plurality of projections extends from the housing diametrically equidistant from each other and each projection is capable of travelling in a linear groove in the valve stem. Alternatively, a plurality of projections extends from a side of the valve stem diametrically equidistant from each other and each projection is capable of travelling in a linear groove in the housing. Preferably, small humps are provided in the groove(s). Preferably, each groove has first and second longitudinal limits and a small hump is provided adjacent each limit. This provides the advantage of providing a form of tactile feedback when the projection(s) travel over them thereby indicating whether the valve is open or closed.

Preferably, a buffer is provided at the ends of the groove(s). More force is required for the projections to travel over the buffers compared to the force required to travel over the humps. Advantageously, the buffers prevent the valve housing and valve stem from being disassembled in use. The force needed to assemble the components together can be created using a press during manufacture.

Preferably, the plug is resilient.

Preferably, the plug is tapered. Preferably, the taper of the plug corresponds to a taper in the channel so that the plug abuts the seat when the plug and the seat are in in a first position relative to each other, thereby closing the channel.

Preferably, the seat for the plug is defined by a taper in the channel defined by the valve stem.

Preferably, the channel has a cross section perpendicular to the longitudinal axis of the outlet which is circular.

Preferably, the valve housing can rotate only partly around the valve stem when the valve is fully open or fully closed. More preferably, the valve housing can rotate up to about 180 degrees around the valve stem when the valve is fully open or fully closed. This provides the advantage of locking the valve and preventing the housing from moving in a linear motion that would open or close the valve. This is especially advantageous when connected to a night collection bag, so that it does not accidentally close during the night. In this regard, preferably a part annular groove extends only partly around the valve stem or the housing adjacent each end of the helical or straight groove. In this regard, preferably, the part annular groove forms a continuation of the helical or straight groove. Preferably, a projection extends from the housing and is capable of travelling in a part annular groove in the valve stem. Alternatively, a projection extends from the valve stem and is capable of travelling in a part annular groove in the housing. This provides the advantage that, the plug remains sealed against the seat, or at the same distance away from the seat (therefore remaining open) during radial rotation of the housing relative to the valve stem.

Preferably, small humps are provided in the part annular groove(s) adjacent the ends of the part annular groove(s). Advantageously, the small humps provide tactile feedback when the projections travel over them indicating when the valve is locked.

Preferably, each projection has its own corresponding groove. In this regard, preferably, the projections are provided on opposite sides of valve stem or the valve housing, but offset from one another axially.

Preferably, a surface indication is provided on the housing to make clear to a user when the valve is locked. In this regard, preferably, a padlock symbol is provided on the surface to provide a clear indication. Preferably, the symbol is slightly raised from the surface to provide tactile feedback. For example, the symbol is moulded into the surface.

Preferably, a drip cap is provided. Advantageously, the drip cap gives further security against leakage and instils further confidence to a user. In this regard, preferably the outlet has a soft resilient tip and a bung preferably manufactured together of a single moulding.

Preferably, the bung has one or more barbs extending therefrom to provide a secure fit in the soft resilient tip to provide the desired retention. Preferably, two barbs are provided, but there could be more or less. Advantageously, the retention is required to be less than for a known soft bung type tap because in the present case it is included merely as a drip cap and, in contrast to known outlets, it is not intended to be relied on as a primary seal.

The soft resilient tip has the additional advantage of providing an interface for a tube of a night collection bag. In this regard, barbs of a tube of a night collection bag can secure the tube in the soft resilient tip.

Preferably, the soft resilient tip is provided by an over mould.

Advantageously, due to the soft tip, an additional adapter is not required to attach the outlet to a night collection bag. This reduces the number of parts, cost and complexity to the user.

Preferably, the soft resilient tip has an increased wall thickness compared to the walls of the housing so that it returns back to its original shape when the night collection bag tube is removed. Preferably, the length and diameter of the soft resilient tip is configured so that it can be universal and interface with all night collection bags that have a barbed component on their tube.

Preferably, a plurality of ridges or indentations is provided in the outer surface of the housing. Preferably, in a first embodiment the ridges or indentations are linear and perpendicular to the longitudinal axis of the outlet. Preferably, in a second embodiment, the ridges or indentations are linear and parallel with the longitudinal axis of the outlet. Preferably the ridges or indentations are of soft material. Advantageously, the ridges or indentations facilitate gripping the housing. This is especially useful when a user's hands are wet.

Preferably, the outlet has soft surfaces. In addition, preferably it has a smooth shape.

This provides the advantage of comfort when worn against a body of a user. Preferably, the valve stem has an end for adjoining to a urostomy bag, wherein the end is an elliptical tube having a long diameter and a short diameter and the wall of the tube is thicker and tapered to a point on the long diameter. This provides the advantage that the surface of the valve stem which adjoins a urostomy bag is as close to a singular plane as possible so that there is no void when welding the valve stem to the film of a urostomy bag.

Preferably, the housing and the valve stem are manufactured of a polyolefin (for example polyethylene (PE), polypropylene (PP), polymethyl pentene (PMP), polybutene-1 (PB-1) and would typically be low density polyethylene (LDPE) as it can be welded to the bag film of an ostomy bag and can provide a good seal. (LDPE is defined by a density range of 0.917-0.930 g/cm³). Alternatively, a more rigid material such as acrylonitrile butadiene styrene (ABS) or polycarbonate (PC) is used. The material used to create soft parts is preferably a thermoplastic elastomers (TPE) based on the primary material selected. For example, if LDPE is selected a PE based elastomer is used.

In accordance with a second aspect of the present invention there is provided a urostomy bag which comprises an outlet according to the invention.

Brief Description of the Drawings

The invention will now be further described with reference to the accompanying drawings in which:

Figure 1 shows a front view of a first embodiment of an outlet of the present invention;

Figure 2 shows a back view of an outlet of the present invention;

Figure 3 shows a housing of a first embodiment of an outlet of the present invention;

Figure 4 shows a valve stem of a first embodiment of an outlet of the present invention; Figure 5 shows a first embodiment of a urostomy bag of the present invention;

Figure 6 shows a front view of a second embodiment of an outlet of the present invention;

Figure 7 shows a housing of a second embodiment of an outlet of the present invention;

Figure 8 shows a valve stem of a second embodiment of an outlet of the present invention; and

Figure 9 shows a second embodiment of a urostomy bag of the present invention;

Detailed Description of the Invention

It will be appreciated that aspects, embodiments and preferred features of the invention have been described herein in a way that allows the specification to be written in a clear and concise way. However, unless circumstances clearly dictate otherwise, aspects, embodiments and preferred features can be variously combined or separated in accordance with the invention. Thus, preferably, the invention provides a device having features of a combination of two or more, three or more, or four or more of the aspects described herein. In a preferred embodiment, a device in accordance with the invention comprises all aspects of the invention.

Within the context of this specification, the word "about" means plus or minus 20%, more preferably plus or minus 10%, even more preferably plus or minus 5%, most preferably plus or minus 2%.

Within the context of this specification, the word "comprises" means "includes, among other things" and should not be construed to mean "consists of only". Within the context of this specification, the word "substantially" means preferably at least 90%, more preferably 95%, even more preferably 98%, most preferably 99%.

Within the context of this specification, "over moulding" refers to a process of adding an additional layer of material over an already existing piece or part. This allows resins to be combined to provide characteristics that no single resin can deliver without additional costly assembly steps. In the present invention, it enables mechanical properties of rigid resilient material to be used to allow a valve to open or close in combination with soft materials which, for example, provide comfort, grip and a reliable connection to existing night drainage bag connectors.

Over moulding typically involves the substrate part to be removed from one set of tools and placed in another set to create the over mould. Alternatively, the part can be made using a two-shot injection mould process, allowing the part to be produced in a single machine cycle.

According to the present invention, a soft over moulded part preferably has Shore value of about Shore A 40 - 100, whereas the supporting substrate preferably has a Shore value of about Shore D 49-90.

As shown in figures 1 to 9, the present invention provides an outlet (1) for a urostomy appliance (20, 21) having a valve comprising a housing (2), a valve stem (3) and a plug (4), wherein the plug (4) is fixed in position relative to the housing (2), the valve stem (3) defines a channel (7) between a first opening (5) and a second opening (6), the channel (7) being parallel with a longitudinal axis of the outlet (1), wherein the channel (7) defines a seat (8) for the plug (4), the housing (2) surrounds the valve stem (3) and is configured to be movable together with the plug (4) relative to the valve stem (3) parallel with the longitudinal axis of the outlet (1) between a first position wherein the plug (4) abuts the seat (8) thereby closing the channel (7) and a second position wherein the plug (4) does not abut the seat (8) thereby opening the channel (7). Referring to figures 1 to 4, in a first embodiment, two projections (9) extend from the housing (2) and each projection (9) is capable of travelling in a helical groove (10) in the valve stem (3).

In this embodiment, the housing (2) surrounds the valve stem (3) and is configured to be movable together with the plug (4) relative to the valve stem (3) so that, as the projection (9) travels in the helical groove (10), the housing (2) and the plug (4) rotate relative to the valve stem (3), they also move parallel with the longitudinal axis of the outlet (1).

Advantageously, the change in the position of the housing (2) relative to the position of the valve stem (3) provides a useful indicator to a user, indicating whether the outlet (1) is open (for drainage, or for when connected to a night drainage bag), or is safely closed.

The helical grooves (10) have first and second ends (11, 12), which limit rotation of the housing (2) and the plug (4) relative to the valve stem (3). When the projection (9) abuts the first end (11) or the second end (12) of the groove (10), further rotation and axial movement of the housing (2) and plug (4) relative to the valve stem (3) is prevented.

Advantageously, moving the housing (2) relative to the valve stem (3) in this way provides a clear indication to the user that the outlet (l)is open or closed because the valve stem (3) separates longitudinally from the housing (2) when open.

The outlet (1) is similar to what is seen on a poppet valve where a tapered plug (4) seals a channel having a circular cross section (7). When the housing (2) is rotated 180 degrees, the tapered plug (4) moves helically away from the seat (8) it was seated on to allow a flow of urine from the urostomy bag (20, 21). This is achieved by two opposite projections (9) on the housing (2) traveling along a helical groove (10) in the valve stem (3). To indicate that the outlet (1) is open or closed, small humps (15) are provided in the groove (10) to provide a form of tactile feedback when the projections (9) travel over them.

To assemble the housing (2) to the valve stem (3) they are placed at 90 degrees to one another and the valve stem (3) is pressed into the housing (2). In this position, the projections (9) can run along grooves (10) until they reach the helix. There is a buffer (14) at the end (11) of each groove (10) that requires a higher additional force for the projections (9) to travel over. This prevents the assembly from becoming disassembled whilst in use. The initial force needed to assemble these components together would be created using a press during manufacture.

To create a drip cap which gives further security and instils further confidence to the user, the outlet (1) has a soft tip (15) with a bung style cap (16) out of one moulding. The bung (16) has 2 barbs (17) on it to provide the desired retention, but this could be more or less. The retention is required to be less on this than a typical known soft bung style tap as this is only a drip cap and not relied on as a primary seal.

The soft tip (15) also provides an interface for a tube of a night collection bag to be pressed into and secured by barbs of the night collection bag. The soft tip (15) has an increased wall thickness so that it returns back to its original shape when the night collection tube is removed. The length and diameter of the soft tip (15) is so that it can be universal and work with all night collection bags that have a barbed component on the tube.

The soft tip (15) is provided by an over mould.

Advantageously, an additional adapter is not required to attach the outlet (1) to a night collection bag due to the soft tip (15). This reduces the number of parts, cost and complexity to the user.

To further aid grip, soft sections are moulded in (18), this would be especially useful when the user's hands are wet. All of the soft sections (18), accompanied with the smooth organic shape of the outlet (1) provide comfort when worn against the body of a user.

The soft mouldings (18) are moulded with vertical grooves (19) to signify a twist motion is required to open.

The valve stem has an end (23) for adjoining to a urostomy bag (20, 21), wherein the end (23) is an elliptical tube having a long diameter and a short diameter and the wall of the tube is thicker and tapered to a point (25) on the long diameter. This provides the advantage that the surface of the valve stem (3) which adjoins a urostomy bag is as close to a singular plane as possible so that there is no void when welding the valve stem (3) to the film of a urostomy bag (20, 21).

Both the housing (2) and the valve stem (3) are made from LDPE as it can be welded to the bag film and can provide a good seal. Alternatively, a more rigid material such as ABS or PC could be used. The other material of the two shot moulding to create the soft parts would be a TPE based on the primary material selected. For example, if LDPE is selected a PE based elastomer would be used.

Referring to figure 5, a urostomy appliance in the form of a urostomy bag (20) comprises an outlet (1) according to a first embodiment.

Referring to figures 6 to 8, in a second embodiment, the housing (2) is moved in a linear longitudinal direction along a valve stem (3) substantially without rotating in order to open and close the outlet (1). When the outlet (1) is fully open or fully closed, the housing (2) can rotate about 180 degrees around the valve stem (3) in order to lock the outlet (1) open or closed and prevent the housing (2) moving relative to the valve stem (3) in a linear longitudinal motion that would open or close the outlet (1). This is especially useful when connected to a night collection bag, so that it does not accidentally close during the night. The outlet (1) used is similar to what is seen on a poppet valve where a tapered plug (4) seals a channel (7) having a circular cross section. In use, when the housing (2) is pulled away from the urostomy bag (21), the tapered plug (4) moves in a linear motion away from the seat (8) it was seated on to allow a flow of urine through the channel (7) in the valve stem (3). This is achieved by two opposite projections (9) extending from the housing (2) traveling along a groove (10) in the valve stem (3). To indicate that the outlet (1) is open or closed, small humps (13) are provided in the groove (10) to provide a form of tactile feedback when the projections (9) travel over them. Two buffers (11, 12) are also included that require more force for the projections (9) to travel over and they therefore prevent the valve housing (2) and valve stem (3) from being disassembled in use. The initial force needed to assemble these components together would be created using a press during manufacture.

To lock the outlet (1) from being opened and closed, the housing (2) can be rotated 180 degrees. When moving in this motion, the plug (4) will either remain sealed against the seat (8), or at the same distance away from the seat (8) (therefore remaining open). 4 semi-circular grooves (10) allow the two projections (9) on the valve housing (2) to travel around the groove (10). As a result, the housing (2) can no longer be pulled in a linear motion. These semi-circular grooves (10) also have humps (13) in both extreme positions (11, 12) to provide tactile feedback of when it is locked as the projections (9) travel over them. Each projection (9) has its own groove (10) for when the outlet (1) is open or closed. The projections (9) are opposite, but offset from one another to allow enough space for grooves (10) to enable the housing (2) to rotate only 180 degrees relative to the valve stem (3). Alternatively, a single projection (9) could be used with one longitudinal groove (10) and two semicircular grooves (10).

To make clear to the user when the valve is locked, a padlock (24) is moulded into the surface of the outlet (1) to provide a clear indication. The padlock (24) could also be slightly raised to provide a form of tactile feedback. To create a drip cap which gives further security and instils further confidence to the user, the outlet (1) has a soft tip (15) with a bung style cap (16) out of one moulding. The bung has 2 barbs (17) on it to provide the desired retention, but this could be more or less. The force of retention is required to be less than for a typical soft bung style tap as this is only a drip cap and not relied on as a primary seal.

The soft tip (15) also provides an interface for a tube of a night collection bag to be pressed into the tap and secured by barbs. The soft tip (15) has an increased wall thickness so that it returns back to its original shape when the night collection bag adapter is removed. The length and diameter of the soft tip (15) is so that it can be universal and work with all night collection bags that have a barbed component on the tube.

The soft tip (15) is provided by an over mould.

Advantageously, an additional adapter is not required to attach the outlet (1) to a night collection bag due to the soft tip. This reduces the number of parts, cost and complexity to the user.

To further aid grip, soft sections (18) are over moulded in to the housing (2) to provide ridges (22) substantially perpendicular to the longitudinal axis of the outlet. This is especially useful when a user's hands are wet. All of the soft sections (18), accompanied with the smooth organic shape of the outlet (1) provide comfort when worn against the body of a user.

The valve stem (3) has an end (23) for adjoining to a urostomy bag (21), wherein the end is an elliptical tube having a long diameter and a short diameter and the wall of the tube is thicker and tapered to a point (25) on the long diameter. This provides the advantage that the surface of the valve stem which adjoins a urostomy bag (21) is as close to a singular plane as possible so that there is no void when welding the valve stem (2) to the film of a urostomy bag (21). The housing (2) and the valve stem (3) are made from LDPE as it can be welded to the bag film and can provide a good seal. Alternatively, a more rigid material such as ABS or PC could be used. The other material of the two shot moulding to create the soft parts would be a TPE based on the primary material selected. For example, if LDPE is selected a PE based elastomer could be used.

Referring to figure 9, a urostomy appliance in the form of a urostomy bag (21) comprises an outlet (1) according to a second embodiment.

Examples

Example 1

A test was carried out to analyse whether users understood and found useful the symbols chosen for a mechanical tap concept. In addition to this, the study helped to further check whether users intuitively understood the twist-to-open design without an IFU or prior instruction.

Summary of Problem

The inclusion of a visual indicator that clearly identifies when the tap is open or closed was investigated'. In this regard, a formative study was carried out to investigate whether indicators chosen for a mechanical tap clearly signified whether a tap was open or closed.

Study Objectives

• To investigate whether chosen visual indicators on a mechanical tap design were understood to signify whether a tap is open or closed

• To investigate whether design features intuitively suggest to a user that a tap has a twist-to-open valve

Methodology

Participants All participants had minimal previous involvement in mechanical tap development.

Participants had their age, gender and handiness recorded to verify whether this effected the results. Any visual impairments were not considered at this point.

Environment

Due to constraints put in place for Covid 19, the study could not be carried out in a simulated environment. Further environmental influences were not be considered at this point.

Tools & Equipment

Participants received the below items:

Training

Each participant was given background information on a urostomy product and the mechanical tap, but no further instructions were given.

Roles

One person gave instructions to all participants.

Procedure

4.6.1 Recruitment

Participants were recruited by Microsoft Teams or in person.

4.6.2 The Session

Pre-Study 1. A product according to the invention was placed in either an open or closed position for each study (As per Table 1).

2. An initial brief was provided on what the study would involve.

3. Each participant was given a Participant Information sheet to fill out.

4. Each participant was asked to sanitise their hands.

The Study

1. Each participant wore a belt and belt plate around their waste (The bag was already be attached to the belt plate, with the tap in an open or closed position).

2. Each participant was given time to study the bag.

3. Each participant was asked Question 1 - did they think the mechanical tap is open or closed?

4. Each participant was asked Question 2 - what made them feel the tap was open or closed?

5. Each participant was asked to either remove the drip cap and open the tap OR replace the drip cap and close the tap.

6. Each participant was asked Question 3 - What made them feel like twisting the tap would close/open it?

Post Test

1. Bag and belt were sanitised.

2. Test conductors sanitised their hands.

Results

Participant number 3 and participant number 8 were excluded from the study (Highlighted in yellow):

• Participant 3 was given the product in the open position but with the bung closed, which does not follow the methodology of this study.

• Participant 8 revealed they had used the product recently, which did not match the participant intended for this study.

Unshaded Box = Correct Answer Shaded Box = Incorrect Answer

Table 1 - Results Table

Table 2 - % of participants who correctly perceived the initial tap position

Insights

• 5/10 people intuitively understood that the tap required a twist to turn. 3 out of those 5 participants mentioned that included design features aided this understanding (e.g. "you have to turn the tap to reveal the drip icon") The other 2 participants achieved the twisting motion through trial and error.

• 6/10 participants noticed the drip cap position and thought it was an indicator to the tap position. Participants seeing the drip cap in the closed or open position had their perception influenced.

• No trends could be found when relating the results to age, gender or handiness.

The above described embodiments have been given by way of example only, and the skilled reader will naturally appreciate that many variations could be made thereto without departing from the scope of the invention.

Claims

23

CLAIMS An outlet for a urostomy appliance having a valve comprising a housing, a valve stem and a plug, wherein the plug is fixed in position relative to the housing, the valve stem defines a channel between a first opening and a second opening, the channel being parallel with a longitudinal axis of the outlet, wherein the channel defines a seat for the plug, the housing surrounds the valve stem and is configured to be movable together with the plug relative to the valve stem parallel with the longitudinal axis of the outlet between a first position wherein the plug abuts the seat thereby closing the channel and a second position wherein the plug does not abut the seat thereby opening the channel. An outlet according to claim 1 wherein at least one projection extends from the housing and the projection is capable of travelling in a helical groove in the valve stem, or at least one projection extends from the valve stem which is capable of travelling in a helical groove in the housing. An outlet according to claim 1 or claim 2, wherein the housing surrounds the valve stem and is configured to be movable together with the plug relative to the valve stem so that as the projection travels in the helical groove, the housing and the plug capable of rotating relative to the valve stem and also moving relative to the valve stem parallel with the longitudinal axis of the outlet. An outlet according to any one of claims 1 to 3, wherein a change in the position of the housing relative to the position of the valve stem provides a useful indicator to a user, indicating whether the outlet is open or closed. An outlet according to any one of claims 1 to 4, wherein the helical groove has first and second ends, which limit rotation of the housing and the plug relative to the valve stem. An outlet according to any one of claims 1 to 5, wherein two helical grooves are provided. An outlet according to claim 6, wherein the two helical grooves are arranged diametrically opposite each other. An outlet according to claim 6 or claim 7, wherein two projections extend from opposite sides of the housing each of which are capable of travelling in a helical groove in the valve stem, or two projections extend from opposite sides of the valve stem each of which are capable of travelling in a helical groove in the housing, a projection extends from a side of the housing which is capable of travelling in a helical groove in the valve stem and a projection extends from a side of the valve stem which is capable of travelling in a helical groove in the housing. An outlet according to any one of the preceding claims, wherein a plurality of helical grooves is provided. An outlet according to claim 9, wherein the plurality of helical grooves is arranged so that the grooves are diametrically equidistant from each other. An outlet according to claim 9 or claim 10, wherein a plurality of projections extends from the housing diametrically equidistant from each other and each projection is capable of travelling in a helical groove in the valve stem, or a plurality of projections extend from a side of the valve stem diametrically equidistant from each other and each projection is capable of travelling in a helical groove in the housing. An outlet according to claim 1, wherein the housing and the plug are configured to be movable relative to the valve stem only linearly and parallel with the longitudinal axis of the outlet. An outlet according to claim 12, wherein the housing and the plug are configured to allow no rotation of the housing and the plug relative to the valve stem. An outlet according to claim 12 or claim 13, wherein a projection extends from the housing which is capable of travelling in a linear straight groove in the valve stem, or a projection extends from the valve stem which is capable of travelling in a linear straight groove in the housing, and the housing surrounds the valve stem and is configured to be movable together with the plug relative to the valve stem so that as the projection travels in the linear straight groove, the housing and the plug are capable of moving relative to the valve stem only parallel with the longitudinal axis of the outlet. An outlet according to claim 14, wherein two linear grooves are provided. An outlet according to claim 15, wherein the two linear grooves are arranged diametrically opposite each other. An outlet according to claim 15 or claim 16, wherein two projections extend from opposite sides of the housing each of which are capable of travelling in a linear groove in the valve stem, or two projections extend from opposite sides of the valve stem each of which are capable of travelling in a linear groove in the housing, or a projection extends from a side of the housing which is capable of travelling in a linear groove in the valve stem and a projection extends from a side of the valve stem which is capable of travelling in a linear groove in the housing. An outlet according to any one of claims 14 to 17, wherein a plurality of linear grooves is provided. An outlet according to claim 18, wherein the plurality of linear grooves is arranged so that the grooves are diametrically equidistant from each other. An outlet according to claim 18 or claim 19, wherein a plurality of projections extends from the housing diametrically equidistant from each other and each projection is capable of travelling in a linear groove in the valve stem, or a plurality of projections extends from a side of the valve stem diametrically equidistant from each other and each projection is capable of travelling in a linear groove in the housing. 26 An outlet according to any one of claims 2 to 11 or 14 to 20, wherein humps are provided in the groove(s) adjacent the end of the grooves. An outlet according to any one of claims 2 to 11 or 14 to 21 wherein each groove has first and second longitudinal limits and a small hump is provided adjacent each limit. An outlet according to any one of claims 2 to 11 or 14 to 22, wherein a buffer is provided at the ends of the groove(s). An outlet according to any one of the preceding claims, wherein the plug is resilient. An outlet according to any one of the preceding claims, wherein the plug is tapered. An outlet according to claim 25, wherein the plug has a taper which corresponds to a taper in the channel so that the plug abuts the seat when the plug and the seat are in in a first position relative to each other, thereby closing the channel. An outlet according to any one of the preceding claims, wherein the seat for the plug is defined by a taper in the channel defined by the valve stem. An outlet according to any one of the preceding claims, wherein the channel has a cross section perpendicular to the longitudinal axis of the outlet and the cross section is circular. An outlet according to any one of the preceding claims, wherein the valve housing can rotate only partly around the valve stem when the valve is fully open or fully closed. An outlet according to claim 29, wherein the valve housing can rotate up to about 180 degrees around the valve stem when the valve is fully open or fully closed. 27 An outlet according to claim 29 or claim 30, wherein a part annular groove extends only partly around the valve stem or the housing adjacent each end of the helical or straight groove. An outlet according to any one of claims 29 to 31, wherein one or more projections extend from the housing and each projection is capable of travelling in a part annular groove in the valve stem, or one or more projections extend from the valve stem and each projection is capable of travelling in a part annular groove in the housing. An outlet according to claim 31 or claim 32, wherein humps are provided in the part annular groove(s) adjacent the ends of the part annular groove(s). An outlet according to claim 32 or claim 33, wherein projections are provided on opposite sides of valve stem or the valve housing, but offset from one another axially. An outlet according to any one of claims 29 to 34, wherein a surface indication is provided on the housing to make clear to a user when the valve is fully closed, optionally, wherein the surface indication is a padlock symbol and / or the surface indication is slightly raised from the surface to provide tactile feedback. An outlet according to any one of the preceding claims, wherein a drip cap is provided. An outlet according to any one of the preceding claims, wherein the outlet has a soft resilient tip and a bung which sealingly fits into the tip, optionally manufactured together of a single moulding. An outlet according to claim 37, the bung has one or more barbs extending therefrom to provide a secure fit in the soft resilient tip. An outlet according to claim 37 or 38, wherein the soft resilient tip is provided by an over mould. 28 An outlet according to any one of claims 37 to 39, wherein the soft resilient tip has an increased wall thickness compared to the walls of the housing so that it returns back to its original shape when the night collection bag tube is removed. An outlet according to any one of claims 37 to 40, wherein the length and diameter of the soft resilient tip is configured so that it can be universal and interface with a tube of a night collection bag. An outlet according to any one of the preceding claims, wherein a plurality of ridges or indentations is provided in the outer surface of the housing, optionally wherein the ridges or indentations are of soft material. An outlet according to claim 42, wherein the ridges or indentations are linear and perpendicular to the longitudinal axis of the outlet, or the ridges or indentations are linear and parallel with the longitudinal axis of the outlet. An outlet according to any one of the preceding claims, wherein the outlet has soft surfaces and / or a smooth shape. An outlet according to any one of the preceding claims, wherein the valve stem has an end for adjoining to a urostomy bag, wherein the end is an elliptical tube having a long diameter and a short diameter and the wall of the tube is thicker and tapered to a point on the long diameter. A urostomy bag comprising an outlet according to any one of claims 1 to 45.