GB2609884A

GB2609884A - Drainable ostomy pouch

Info

Publication number: GB2609884A
Application number: GB2103102.6A
Authority: GB
Inventors: P R Goswell Nicholas; A P Murphy Ross; D Bray Chris; Hopper Jack; Poole Theodore
Original assignee: Welland Medical Ltd
Current assignee: Welland Medical Ltd
Priority date: 2021-03-05
Filing date: 2021-03-05
Publication date: 2023-02-22
Also published as: AU2022229951A1; EP4301295A1; WO2022185071A1; GB202103102D0

Abstract

A pouch 1 for an ostomy bag has first (2, fig 3) and second sidewalls 3 forming a cavity therebetween. The side walls define a foldable neck portion 5 terminating in a discharge opening 6 for draining contents of the pouch from the cavity, the discharge opening being closed and opened by folding and unfolding the neck portion from a folded configuration to an unfolded configuration respectively. A flap fastener 12 is provided on one side of the pouch to releasably secure the neck portion in the folded configuration, wherein the flap fastener has a width about 14- 68% of the width of the neck portion or about 10-48mm.

Description

Drainable Ostomy Pouch The present invention relates to a drainable ostomy pouch comprising a closure. The closure allows a neck of an ostomy pouch to be closed so that the contents of the ostomy pouch do not leak until the closure is opened so that the contents can be drained. In particular, the closure operates to retain the pouch contents during use and allowing disposal of the contents more readily and hygienically after use.

Background of the Invention

Ostomy pouches for receiving bodily waste from colostomy or ileostomy patients are well known. A problem with such pouches lies in the provision of an opening/closing mechanism of the pouch. Such a mechanism must provide a good seal, indicate when fastened, remain secure to prevent leakage of the bags contents whilst also ensuring an easy way of opening the closure to allow for the neck to be unfolded and the contents drained.

EP1750628 discloses a drainable ostomy pouch for an ostomy bag. The pouch has first and second side walls forming a cavity therebetween. The side walls define a foldable neck portion terminating in a discharge opening for draining contents of the pouch from the cavity. The discharge opening is capable of being closed and opened by folding and unfolding the neck portion.

A first wall of the neck portion has a first transversely-extending resiliently flexible member adjacent the discharge opening and a second transversely-extending resiliently flexible member adjacent the first flexible member.

A second side wall of the neck portion has a pull tab to facilitate separation of the first and second walls to open the neck for draining the contents of the pouch.

The drainable ostomy pouch of EP1750628 works well. However, there is a need for an improved closure for a drainable ostomy pouch.

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 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 a pouch for an ostomy bag, the pouch having first and second sidewalls forming a cavity therebetween, the side walls defining a foldable neck portion terminating in a discharge opening for draining contents of the pouch from the cavity, the discharge opening being closed and opened by folding and unfolding the neck portion from a folded configuration to an unfolded configuration respectively, a flap fastener being provided on one side of the pouch to releasably secure the neck portion in the folded configuration, wherein the flap fastener has a width being about 14% to about 68% of the width of the neck portion.

Advantageously, it has been found that when the discharge outlet is closed, a flap fastener having a width of about 14% to about 68% the width of the neck portion enables a user to open the discharge outlet by applying opposing forces to the neck portion and the flap fastener. Thus, the invention provides an easy way of opening the discharge opening by providing surfaces for a user to apply opposing forces to.

Preferably, the flap fastener has a minimum width of about 28% the width of the neck portion. Preferably, the flap fastener has a maximum width of about 60% the width of the neck portion. Advantageously, it has been found that a minimum width of 28% the width of the neck portion and a maximum width of 60% the width of the neck portion provides a factor of safety of two times the minimum width and more easily enables a user to open the discharge outlet by applying opposing forces to the neck portion and the flap fastener respectively.

In a second aspect, there is provided a pouch for an ostomy bag, the pouch having first and second sidewalls forming a cavity therebetween, the side walls defining a foldable neck portion terminating in a discharge opening for draining contents of the pouch from the cavity, the discharge opening being closed and opened by folding and unfolding the neck portion from a folded configuration to an unfolded configuration respectively, a flap fastener being provided on one side of the pouch to releasably secure the neck portion in the folded configuration, wherein the flap fastener has a width being about lOmm to about 48mm.

Preferably, the flap fastener has a minimum width of about 20mm. Preferably, the flap fastener has a maximum width of about 42mm. Advantageously, it has been found that a minimum width of about 20mm and a maximum width of about 42mm provides a factor of safety of two times the minimum width and more easily enables a user to open the discharge outlet by applying opposing forces to the neck portion and the flap fastener respectively.

Preferably, in the folded configuration the flap fastener extends beyond the bottom of the folded neck portion. This provides the advantage of providing a tab which further improves the ease of opening.

Preferably, the flap fastener comprises a mechanical fastener, which releasably fastens to the neck portion in the folded configuration. This provides the advantage of releasably securing the neck portion in the folded configuration.

Preferably, the mechanical fastener comprises hooks, which engage with corresponding hooks on the neck portion. For example, the mechanical fastener comprises a hook to hook closure such as Aplix 966 C). Advantageously, this type of closure is sensory and therefore gives the benefit of high tactile and audible feedback to the user, indicating when the fastener is secured. Alternatively, the mechanical fastener comprises a traditional hook to loop closure such as Velcro C), however this does not have the same sensory benefits.

Preferably, the pouch comprises a wafer on only one wall of the pouch for securing the pouch to a body of a user and the flap fastener is adhered to the other wall (non-wafer side wall) of the pouch. This provides the advantage that in the folded configuration, the folded neck portion is positioned away from the body of a user, thereby avoiding irritation of the skin of the user.

Preferably, a mating fastener which engages with the flap fastener is adhered to the wall of the pouch having the wafer thereon. Advantageously, in use, the flap fastener folds over the folded up neck portion to allow a user to connect the mating fastener with the flap fastener.

Preferably, the neck of the non-wafer side wall has a first transversely-extending resiliently flexible member at the end of the neck adjacent the discharge opening and a second transversely-extending resiliently flexible member adjacent the first flexible member. This provides the advantage of ensuring a reliable seal to the cavity is formed when the members are folded so that the first member lies against the second member and is in contact with the second member substantially over the entire surface of at least one of the members.

Preferably, the members extend substantially across the entire lateral width of the neck portion between the side edges of the neck portion.

Preferably, during folding of the neck portion in use, the first and second members are initially folded with respect to each other such that the first and second members are located either side of the fold.

Preferably, the first and second members are of equal length.

Preferably, a pull tab is provided on the neck portion adjacent the discharge opening.

This provides the advantage of facilitating separation of the walls for draining the contents of the pouch.

S

Preferably, the pull tab extends outwardly from the neck substantially equidistant from the side edges of the neck portion.

Preferably, the pull tab is provided on the side of the neck of the pouch and on the same side of the pouch as the flap fastener. This provides the advantage that a user can pull the pull tab out and away from the body to open the discharge opening.

Preferably, the discharge opening is openable by outwardly directed pressure applied to the pull tab.

Brief Description of the Drawings

The invention will now be further described with reference to the accompanying drawings in which: Figure 1 shows a closure according to an embodiment of the invention in a closed configuration; Figure 2 shows a closure according to an embodiment of the invention being closed; Figure 3 shows a first side of closure according to an embodiment of the invention in an open configuration; Figure 4 shows a second side of closure according to an embodiment of the invention in an open configuration; Figure 5 shows a closure according to an embodiment of the invention being closed; and Figure 6 shows a closure according to an alternative embodiment of the invention in a closed configuration.

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. In a preferred embodiment, a device in accordance with the invention comprises all preferred features of the invention.

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 "about" means preferably plus or minus 100/c, more preferably plus or minus 5%, even more preferably plus or minus 2%, most preferably plus or minus 1%.

Within the context of this specification, the word "substantially" means preferably 80%, more preferably 90%, even more preferably 95%.

Within the context of this specification, the word "pouch" means the pouch of an ostomy bag, which receives and carries bodily waste.

Referring to Figures 1 to 6, a drainable ostomy pouch (1) has two generally parallel side walls (2, 3) of polymeric film or similar material suitable for an ostomy pouch or the like. The side walls are joined along their edges (4) to provide a cavity therebetween in which bodily waste can be contained. Part of the side walls (2, 3) define a neck portion (5) of the pouch (1) which terminates in a discharge opening (6) to allow drainage of the contents of the pouch (1) when the discharge opening (6) is in an open condition.

Figure 3 shows a first side wall (2) of the ostomy pouch (1). On this side wall (2), a first transversely-extending elongate member (7) is located at the end of the neck portion (5) of the pouch (1). The member (7) is flat when the discharge opening (6) is in its closed condition. The member (7) is of a stiff but resiliently flexible plastics material.

The first member (7) extends substantially across the entire lateral length of the neck portion (5) between the side edges (8, 9) of the neck portion (5).

A second transversely-extending elongate member (10) is located adjacent and parallel to the first member (7). The second member (10) is of the same material as the first member (7) and is flat when the discharge opening (6) is in its closed condition. Like the first member (7), the second member (10) extends across substantially the entire lateral width of the neck portion (5) between the side edges (8, 9) of the neck portion (5).

A wafer (11) of a skin friendly adhesive barrier material is attached to a first side wall (2) of the pouch (1). The wafer (11) serves to attach the pouch (1) to the skin surface of a wearer of the ostomy pouch (1) in a manner well known in the art. Both the side wall (2) and the wafer (11) have apertures for receiving a stoma, in a manner which is also well known in the art.

As shown in Figure 4, a second side wall (3) of the ostomy pouch (1) has a flap fastener (12) provided at the base of the neck portion (5). The flap fastener (12) is configured to engage with a complimentary mating fastener (13) located on the other side (2) wall of the pouch.

When folded into the closed configuration, the neck portion (5) is secured under a flap fastener (12). The flap fastener (12) is a piece of non-woven backed film with a mechanical engagement fastener. Alternatively, the film could be backed with a woven material or have no backing at all.

The flap fastener (12) is adhered to the second side wall (3) of the pouch (1) and the mating fastener (13) is adhered to the first side wall (2) of the pouch (1).

The width of the flap fastener (12) is about 28% to about 68% the width between the side edges (8, 9) of the neck portion (5). When the discharge outlet (6) is closed, this provides an easy way of opening the fastener (12) by providing an area for the user to apply opposing forces. When closed, the flap fastener (12) extends beyond the bottom of the folded neck portion (5) to create a tab which further improves the ease of opening.

The first side wall (2) of the pouch (1) has a mating fastener (13) that is narrower than the width of the neck portion (5) giving an surface to create an opposing force when the discharge opening is opened and unfolded improving the ease of use.

The flap fastener (12) and the mating fastener (13) may, for example, be complimentary halves of a hook to hook closure such as Aplix 966 ®. This type of closure is sensory and therefore gives the benefit of high tactile and audible feedback to the user, indicating when the fastener is secured. Alternatively, a traditional hook to loop fastener e.g. Velcro ® or the like could be used. However this does not have the same sensory benefits.

Figure 4 shows a pull tab (14) on the second side wall (3) of the ostomy pouch (1).

The tab (14) extends outwardly from the side wall (3) at a point generally equidistant from the side edges (8, 9) of the neck portion (5). The pull tab (14) is made from a non-stiff material such as polymeric film. A first section (15) of the tab (14) is attached to the sidewall and lies flat next to the first member (7) when the discharge opening (6) is in its closed condition. This first section (15) of the tab (14) is not resilient and simply acts to secure a second section (16) of the tab (14) to the neck portion (5).

Initial folding of the neck portion (5) involves folding the first member (7) and the pull tab (14) upwards against the second member (10). In this way, the first and second members (7, 10) lie against each other either side of the fold (with the pull tab (14) inside the fold). The fact that the fold has a member (7, 10) either side of the fold ensures a sharp fold through which the contents of the chamber cannot pass thus totally sealing the opening and preventing leakage. To close the neck portion (5), the rest of the neck portion (5) is continually folded upwardly until the flap fastener (12) and the mating fastener (13) on either side wall (2, 3) engage and attach to one another to retain the neck portion (5) in a folded configuration.

When the neck portion (5) is unfolded and the members (7, 10) lie flat, the discharge opening (6) allows the contents of the pouch (1) to be drained, but the discharge opening (6) can be opened fully to further assist with draining the contents. The discharge opening (6) is fully opened by applying outwardly directed pressure (away from the plane of the transversely extending member (7) to the pull tab (14) of the neck portion (5). In addition, the opposing side edges (8, 9) of the neck portion (5) are pinched together, thereby curving the first and second transversely extending members (7, 10). The applied pressure causes the side walls of the neck portion (5) to be pulled apart, thereby allowing drainage of the contents of the pouch (1).

As shown in Figure 5 a first embodiment of a pouch (1) of the invention has the flap fastener (12) in a position substantially equidistant between the side edges (8, 9) of the neck portion (5). This ensures that the closure can be opened easily on both sides for either a right or left-handed person.

As shown in Figure 6, in another embodiment of a pouch (1) of the invention, the flap fastener (12) and mating fastener (13) can be positioned closer to one side edge (8) of the neck (5) creating a larger grip area, but therefore also creating a dominant hand bias.

Examples

Example 1

A usability study was carried out to compare this invention to the product described in EP1750628.

The known product has a traditional Velcro fastener, and the width of the flap fastener is equal to the width of the neck portion.

During this study, it was found that 81% of participants felt the closure mechanism of the invention was easier to open and 19% of participants said it was the same. When asked why, participants mainly said this was due to the inclusion of a tab, and the new area to create an opposing force.

65% of participants said they felt more secure and 23% of participants said the closure felt as secure despite the reduced width of the flap fastener. When asked why, participants said the tactile feedback from the hook to hook closure gave them confidence. 81% of participants said the closure was easier or as easy as the known product to close.

Example 2

Whilst the above usability study highlighted that participants felt secure and there was improved ease of use compared to a known product, another study was required to ensure it remained secure in use. To do this, an automated simulated wearing study was conducted. The automated process involves filling up a pouch with dyed water to 75% of its volume before it is run through a sequence of applying 21-23kg of force to the walls of the pouch in different positions, whilst simultaneously aggravating the closure to try and cause the fastener to fail.

This study showed that the flap fastener can be reduced to minimum of 14% of the neck width and still remain secure.

As the materials used are reliable and the use conditions are not severe, a factor of safety of two times the minimum width can be applied and therefore the minimum width of closure with a factor of safety of two is 28% of the width of the neck portion.

Based on both the automated simulated wearing study (Example 2) and usability study (Example 1) it has been found that a flap fastener having a width of about 14% to about 68%, or more preferably about 28% to about 60% the width of the neck portion provides a product having improved ease of use, while remaining secure in use.

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

CLAIMS1. A pouch for an ostomy bag, the pouch having first and second sidewalls forming a cavity therebetween, the side walls defining a foldable neck portion terminating in a discharge opening for draining contents of the pouch from the cavity, the discharge opening being closed and opened by folding and unfolding the neck portion from a folded configuration to an unfolded configuration respectively, a flap fastener being provided on one side of the pouch to releasably secure the neck portion in the folded configuration, wherein the flap fastener has a width being about 14% to about 68% of the width of the neck portion.
2. The pouch according to claim 1, wherein the flap fastener has a width of at least about 28% the width of the neck portion.
3. The pouch according to claim 1 or claim 2, wherein the flap fastener has a width of up to about 60% the width of the neck portion.
4. A pouch for an ostomy bag, the pouch having first and second sidewalls forming a cavity therebetween, the side walls defining a foldable neck portion terminating in a discharge opening for draining contents of the pouch from the cavity, the discharge opening being closed and opened by folding and unfolding the neck portion from a folded configuration to an unfolded configuration respectively, a flap fastener being provided on one side of the pouch to releasably secure the neck portion in the folded configuration, wherein the flap fastener has a width being about lOmm to about 48mm.
5. The pouch according to claim 4, wherein the flap fastener has a minimum width of about 20mm.
6. The pouch according to claim 4 or claim 5, wherein the flap fastener has a width of up to about 42mm.
7. The pouch according to any one of the preceding claims, wherein in the folded configuration the flap fastener extends beyond the bottom of the folded neck portion.
8. The pouch according to any one of the preceding claims, wherein the flap fastener comprises a mechanical fastener, which releasably fastens to the neck portion in the folded configuration.
9. The pouch according to claim 8, wherein the mechanical fastener comprises hooks, which engage with corresponding hooks on the neck portion, or the mechanical fastener comprises a hook to loop closure having hooks on either the flap fastener or the neck portion of the pouch which engage with loops on the other of the neck portion of the pouch or the flap fastener respectively.
10. The pouch according to claim 8 or 9, wherein the mechanical fastener comprises hooks, which engage with corresponding hooks on the neck portion.
11. The pouch according to any one of the preceding claims, wherein a wafer is provided on only one wall of the pouch for securing the pouch to a body of a user and the flap fastener is adhered to the other wall (non-wafer side wall) of the pouch.
12. The pouch according to claim 11, wherein a mating fastener which engages with the flap fastener is adhered to the wall of the pouch having the wafer thereon.
13. The pouch according to any one of the preceding claims, wherein the neck of the non-wafer side wall has a first transversely-extending resiliently flexible member at the end of the neck adjacent the discharge opening and a second transversely-extending resiliently flexible member adjacent the first flexible member.
14. The pouch according to claim 13, wherein first transversely-extending resiliently flexible member and the second transversely-extending resiliently flexible member extends substantially across the entire lateral width of the neck portion between the side edges of the neck portion.
15. The pouch according to claim 13 or claim 14, wherein, during folding of the neck portion in use, first transversely-extending resiliently flexible member and the second transversely-extending resiliently flexible member are initially folded with respect to each other such that the first and second members are located either side of the fold.
16. The pouch according to any one of claims 13 to 15, wherein the first transversely-extending resiliently flexible member and the second transversely-extending resiliently flexible member are of equal length.
17. The pouch according to any one of the preceding claims, wherein a pull tab is provided on the neck portion adjacent the discharge opening.
18. The pouch according to claim 17, wherein the pull tab extends outwardly from the neck substantially equidistant from the side edges of the neck portion.
19. The pouch according to claim 17 or claim 18, wherein the pull tab is provided on the side of the neck of the pouch and on the same side of the pouch as the flap fastener.
20. The pouch according to any one of claims 17 to 19, wherein the discharge opening is openable by outwardly directed pressure applied to the pull tab.