A leak detection device for an ostomy bag

Abstract

A leak detection device (1) for detecting a leak from an ostomy bag (2). The device comprising a moisture-absorbent layer (3) and at least two spaced apart snap fasteners (4, 5) extending through the moisture-absorbent layer (3). The snap fasteners (4, 5) are electrically conductive and can detect a stoma leak via a drop in electrical resistance, potential difference, or both, through the moisture-absorbent layer (3).

Description

A LEAK DETECTION DEVICE FOR AN OSTOMY BAGField of the Invention

[0001] The invention relates to a leak detection device for detecting a leak from an ostomy bag.Background

[0002] Colorectal conditions such as inflammatory bowel disease, trauma, diverticular disease, and malignancy can require surgical intervention and intestinal diversion through the creation of a stoma. The latter is a surgical opening on the abdomen through which the passage of faeces is directed into an external disposable pouch. It has been estimated that there are between 175,000 and 205,000 ostomates (ileostomy, colostomy and urostomy) in the UK, with over 20,000 new stomas created each year. While there have been substantial advances in surgical procedures, complications post release remain considerable and can impact on psychological and physiological wellbeing. The creation of a diverting ileostomy can be particularly problematic where the intestinal surface area for reabsorption can be greatly reduced thereby leading to a high stomal output. Where there is persistent loss of large amounts of small bowel fluid (1500-2000 mL I 24 h), dehydration and electrolyte disorders can arise and are a common factor in the readmission of patients with an ileostomy. High output stomas (HOS) can also greatly increase the propensity towards pouch leakage and peristomal skin complications. Moisture associated skin damage through prolonged exposure to the bowel fluid can be particularly troublesome for patients as it can directly impact on the subsequent adhesion of the collection pouch to the skin.

[0003] A characteristic feature of stoma leakage is that the bowel effluent (particularly from ileostomies where the effluent is largely water) induces a swelling of the hydrocolloid layer and if left to progress, will cause gradual erosion of the hydrocolloid. The gradual erosion then causes the seal between the stoma and hydrocolloid to fail. In most cases, leaks will tend to be caused by a host of factors associated with the morphology of the stoma site (recessed stoma, skin creases etc).

[0004] The present invention seeks to obviate or mitigate the problems outlined above. Specifically, the present invention seeks to provide a leak detection device for detecting a leak from an ostomy bag, and that can alert the wearer when a leak has occurred.Summary of the InventionAccording to a first aspect of the invention there is provided a leak detection device for detecting a leak from an ostomy bag, the leak detection device comprising a moisture-absorbent layer and at least two spaced apart snap fasteners extending through the moisture-absorbent layer, the snap fasteners being electrically conductive.Optionally, the snap fasteners may be male or female snap fasteners.Optionally, part of each snap fastener is located at one side of the moisture-absorbent layer and a further part of each snap fastener is located at the opposing side of the moisture-absorbent layer.Optionally, at least one of the snap fasteners comprises a first component located at one side of the moisture-absorbent layer and a second component located at the opposing side of the moisture-absorbent layer, wherein the first and second components are separate components that are connected to one another.Optionally, the first component is adapted to receive a part of the second component and retain the second component thereto.Optionally, the second component comprises a base and one or more connectors extending from the base, wherein the connectors are configured to engage with the first component and be retained by the first component.Optionally, the one or more connectors are spikes.Optionally, the base is annular.Optionally, the moisture-absorbent layer is a hydrocolloid layer. The hydrocolloid layer may be a composite. The hydrocolloid layer may comprise a gelling agent. The gelling agent may be any one of: locust bean gum, carrageenan, pectin, starch, chitosan,xanthan gum, carboxymethyl cellulose, sodium carboxymethylcellulose, alginate, gelatin, agar.Optionally, the moisture-absorbent layer is a silicone layer. The silicone layer is configured to permit movement of moisture therethrough.Optionally, the leak detection device further comprises a textile layer disposed directly or indirectly on the moisture-absorbent layer, and wherein the snap fasteners extend through the textile layer.Optionally, the textile layer comprises an adhesive backing that adheres the textile layer to the moisture-absorbent layer.Optionally, a cover extends over the snap fastener at one side of the moistureabsorbent layer.Optionally, the snap fastener is formed from carbon composite.Optionally, the snap fastener has been treated with plasma or lasers.Optionally, the leak detection device is integrally formed with an ostomy bag baseplate, or the leak detection device is a baseplate extender.Optionally, the leak detection device further comprises a sensing unit for sensing a leak, the sensing unit being connected to or connectable to the snap fasteners.Optionally, the sensing unit is capable of detecting when there is a change in electrical resistance, potential difference, or both, between two or more of the snap fasteners.Optionally, the sensing unit is capable of providing an alarm when a change in electrical resistance potential difference, or both, is detected.Optionally, the sensing unit is capable of transmitting a signal to a further device, wherein the further device is capable of providing an alarm when a change in electrical resistance potential difference, or both, is detected.According to a second aspect of the invention there is provided a method of manufacturing a leak detection device for detecting a leak from an ostomy bag, comprising the steps of:i) providing a moisture-absorbent layer; ii) installing a first snap fastener by positioning the moisture-absorbent layer between a first component and a second component of the snap fastener; iii) pressing the first component and the second component together with the moisture-absorbent layer therebetween, until the first component and second component have engaged and are retained extending through the moisture-absorbent layer; iv) installing a second snap fastener that is spaced apart from the first snap fastener on the moisture-absorbent layer, following steps ii) and iii) in relation to the first snap fastener; v) wherein the first and second snap fasteners may be installed simultaneously or consecutively.The method may be for manufacturing the leak detection device according to the first aspect of the invention.Optionally, prior to step ii) a textile layer is adhered to the moisture-absorbent layer.Optionally, the method further comprises placing a cover over the snap fastener at one side of the moisture-absorbent layer.Optionally, step iii) involves using a snap fastener plier tool to force the first and second components together.Optionally, one or both snap fasteners are formed from carbon composite.Optionally, the method further comprises the step of treating one or both snap fasteners with plasma or lasers.List of Figures

[0005] Specific implementations of the present disclosure will now be described, by way of example only, and with reference to the accompanying drawings in which:

[0006] Figure 1 shows a standard 2-piece ostomy bag before (A) and after (B) placement of the leak detection device.

[0007] Figure 2 shows (A) components used in the construction of the leak detection device and (B) the final assembly and (C) side view.

[0008] Figure 3 shows the mode of operation for the leak detection device. In the absence of a leak (A) the resistance between the snap fasteners is high - no alarm. In the presence of a leak (B), electrolyte enters the film and a circuit is established and the alarm is activated.

[0009] Figure 4 shows a schematic of the snap fasteners and sensing unit of the present disclosure.Detailed Description

[0010] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which the presently described subject matter pertains. The meaning and scope of these terms should be clear, but in cases of ambiguity, the definitions articulated herein supersede any definitions found in dictionaries or external sources.

[0011] Within the specification and the appended claims, unless explicitly stated otherwise, the ensuing terms are ascribed the meanings outlined:

[0012] The term “adhesive” means a substance for sticking objects together. When used in reference to the adhesive for sticking the textile layer to the moisture-absorbent layer, the adhesive refers to the substance used to stick the textile layer to the moisture-absorbent layer.

[0013] The term “alarm” means a warning, which may be audio or visual. When used in reference to the leak detection device, the alarm refers to the means by which the leak detection device warns the user that a leak has been detected.

[0014] The term "base” when used in reference to the base of a component of the snap fastener means a structure upon which other structures of the component are supported.

[0015] The term “baseplate” when used in reference to an ostomy bag baseplate means a device that adheres to a wearer’s skin at a stoma to protect the skin from stoma output. A known baseplate is shown in Figure 1A, referenced by numeral 26.

[0016] The term "carbon composite” when used in reference to the snap fastener refers to a material formed from carbon fibres embedded in a matrix.

[0017] The term “cover” when used in reference to the cover for the snap fastener refers to a piece of material that extends over and conceals at least some or all the snap fastener at one side of the moisture-absorbent layer.

[0018] The term “extender” when used in reference to the baseplate refers to a device that integrates with an ostomy bag baseplate to increase the area of skin that is covered and protected by the baseplate on a wearer, wherein the area that is covered is a combination of area covered by the baseplate and by the extender.

[0019] The term “hydrocolloid” means a substance that forms a colloid when combined with water, wherein a colloid is a substance comprising large molecules or ultramicroscopic particles dispersed through another substance. In the case of a hydrocolloid, the large molecules or ultramicroscopic particles are dispersed through water. The large molecules or ultramicroscopic particles may be cellulose, gelatin or pectin, for example.

[0020] The term “layer” when used in reference to the moisture-absorbent layer, for example, refers to a physical layer that may be set spread out on a surface, and which optionally may accommodate additional layers on top of it.

[0021] The term “leak” when used in reference to an ostomy bag refers to when the seal between the stoma and the baseplate fails and when stoma output can contact the wearer’s skin.

[0022] The term "moisture” means liquid, which may be water or stoma output such as urine, and which may be present in trace amounts. In the context of the moistureabsorbent layer, the term means that the layer is capable of absorbing liquids such as water and stoma output. The “moisture-absorbent layer” may refer to a liquid- permeable layer that allows liquid to pass through, but may not necessarily retain liquid within the layer.

[0023] The term “ostomy bag” means a device attachable to a wearer to collect waste through a stoma on the wearer. Ostomy bags are also known as an ostomy pouch, stoma bag, or stoma pouch.

[0024] The term “pliers” in reference to the snap fastener tool means a tool with jaws and handles, wherein the first and second components of the snap fastener can be placed within the jaws and the handles squeezed together to cause the jaws to move together, thereby causing the first and second components to move together.

[0025] The term “snap fastener”, also known as snap button, press stud, press fastener, dome fastener or popper, means a component that can be attached to a material such as a fabric, and which is capable of releasably engaging with another snap fastener. Snap fasteners may be releasably engaged with other snap fasteners for the purpose of temporarily joining two pieces of material together, for example. Snap fasteners may be male or female. Male snap fasteners typically have a protrusion that can be received by a socket on a female snap fastener. Typically, the protrusion comprises a groove, and the socket comprises a lip proximal to the opening of the socket that slots into the groove to retain the protrusion in the socket. The male fastener can be removed from the female snap fastener by applying a sufficient pulling force therebetween.

[0026] The term “spike” when used in reference to the snap fastener refers to a component having a pointed end.

[0027] The term “stoma” means an opening in a person’s abdomen that is connected to a digestive or urinary system to allow waste to pass from the digestive or urinary system and out the opening. A stoma is illustrated in Figure 1A, referenced by numeral 27.

[0028] The term “textile” means a fabric, which may be woven from natural fibres, such as cotton, or synthetic fibres, such as polyester. The textile is not necessarily woven and be formed from non-woven materials.

[0029] The term “unit” means a device. When used in the context of a sensing unit, it refers to a device configured to sense when there has been a change in electrical conductivity between the two spaced apart snap fasteners.

[0030] In the figures there is shown a leak detection device 1 for detecting a leak from an ostomy bag 2. The leak detection device 1 has a moisture-absorbent layer 3. Further, in the illustrated embodiment, there are two spaced apart snap fasteners 4, 5 extending through the moisture-absorbent layer 3. The snap fasteners 4, 5 are electrically conductive. In other embodiments not shown, the device may contain more than two snap fasteners. There is further a path for electrical conductivity through the moisture-absorbent layer 3 between the two snap fasteners 4, 5. Ideally, the path between the snap fasteners 4, 5 is direct.

[0031] Snap fasteners are installed with ease through a moisture-absorbent layer, and can be installed by the use of pliers. This ease of manufacture can ensure widespread accessibility of the leak detection device.

[0032] In the illustrated embodiment, the snap fasteners 4, 5 are male snap fasteners. The snap fasteners 4, 5 each have a protrusion 6. The protrusion further has a groove 7. The protrusion is configured to be received by a socket on a corresponding female snap fastener (not shown). The groove 7 accommodates a lip in the socket which then functions to retain the protrusion in the socket. The male and female snap fasteners can thereafter be pulled apart to separate by applying sufficient force to urge the lip from the groove. In other embodiments, one or more snap fasteners in the leak detection device may be female snap fasteners.

[0033] Part 8, 9 of each snap fastener 4, 5 is located at one side 10 of the moistureabsorbent layer 3 and a further part of each snap fastener 4, 5 is located at the opposing side 11 of the moisture-absorbent layer 3.

[0034] Each snap fastener 4, 5 has a first component 12 located at one side 10 of the moisture-absorbent layer 3 and a second component 13 located at the opposing side 11 of the moisture-absorbent layer 3. The first and second components 12, 13 are separate components that are connected to one another. It should be noted that the snap fasteners need not be formed in an identical manner. One snap fastener may be formed in a first configuration, and a second snap fastener formed in a second configuration.

[0035] The first component 12 is adapted to receive a part of the second component13 and retain the second component 13 thereto. The second component 13 comprisesa base 14 and connectors 15 extending from the base, wherein the connectors are configured to engage with the first component 12 and be retained by the first component 12. In the illustrated embodiment, the connectors are spikes, and there are five connectors. More or less than five connectors may be used in other embodiments. Shapes other than spikes may also be suitable provided they connect the first component to the second component. The first component 12 has a slot (not shown) for receiving the connectors. When the connectors are pushed into the slot they bend and are therefore prevented from easily being removed from the slot. In the illustrated embodiment, the base 14 is annular. The connectors 15 are arranged spaced apart around the base.

[0036] In the illustrated embodiment, the moisture-absorbent layer 3 is a hydrocolloid layer. However, other suitable moisture-absorbent materials may be used, for example, alginate, hydrogel or foam-based materials.

[0037] The leak detection device 1 further comprises a textile layer 16 disposed on the moisture-absorbent layer 3. The snap fasteners 4, 5 extend through the textile layer 16. There is an adhesive 17 disposed between the textile layer 16 and the moisture-absorbent layer 3. The textile layer may be formed from breathable material, and may be perforated.

[0038] The leak detection device 1 further has a cover 18 that extends over each snap fastener 4, 5. The cover 18 extends over the snap fasteners 4, 5 at one side of the moisture-absorbent layer 3. More specifically, the cover 18 extends over the second component 13 of the snap fasteners 4, 5. Yet even more specifically, the cover 18 extends over the base 14 of the second component 13 of the snap fasteners 4, 5. The cover is formed of woven or non-woven fabric, or moisture-absorbent material such as hydrocolloid, or foam-based materials.

[0039] In the illustrated embodiment, the snap fasteners 4, 5 are formed from steel. More specifically, they are formed from stainless steel. In an alternative embodiment, the snap fasteners are formed from carbon composite. In this embodiment, the snap fasteners may be treated with plasma or lasers. Treating carbon composites with plasma or lasers can enhance the electrochemical profiles and sensing capabilities of the composite.

[0040] In the illustrated embodiment, the leak detection device 1 is an ostomy bag baseplate extender. The device is placed adjacent to an ostomy bag baseplate to protect the skin around the baseplate in the event of a stoma leak. Alternatively, the leak detection device may be integrally formed with an ostomy bag baseplate. In this alternative embodiment, the snap fasteners are located disposed in the ostomy bag baseplate.

[0041] The leak detection device further comprises a sensing unit 19 for sensing a leak. The sensing unit 19 is capable of detecting when there is a change in electrical resistance, potential difference, or both, between two or more of the snap fasteners 4, 5. As shown in Figure 1 B, the sensing unit 19 can be connected to the snap fasteners 4, 5, using the snap fastening connection. The sensing unit 19 comprises two or more wires 20, that further terminate in or comprise a sensing unit snap fastener 21 for connecting to the snap fasteners 4, 5 of the moisture-absorbent layer 3. The sensing unit snap fastener 21 may be a male or female snap fastener. If the sensing unit snap fastener 21 is a female snap fastener, then the snap fastener 4, 5 on the moistureabsorbent layer will be a male snap fastener. Likewise, if the sensing unit snap fastener 21 is a male snap fastener, then the snap fastener 4, 5 on the moistureabsorbent layer will be a female snap fastener.

[0042] The sensing unit 19 comprises a housing 22, and the wires 20 run from the housing 22 to the snap fasteners 4, 5. The sensing unit 19 may be configured to determine when the moisture-absorbent layer 3 is wet using potentiometry. This is described in further detail below. The housing 22 contains the electronic components necessary for determining when there has been a change in electrical resistance, potential difference, or both, between the two snap fasteners 4, 5. The electronic components of the sensing unit 19 comprise a power source, such as a battery, to create a current flow between the snap fasteners 4, 5. The current flow is established when the moisture-absorbent layer 3 becomes wet, for example, as a result of a leak. The sensing unit 19 further comprises a comparator, set to compare the voltage from the electrodes against a threshold voltage. The sensing unit 19 further comprises an alarm, which may be an audible or visual alarm, to alert when the voltage value from the electrodes passes the threshold voltage of the comparator. Thus, the sensing unit 19 is capable of providing an alarm when a change in electrical resistance, potential difference, or both, is detected. The change in electrical resistance can be caused bya stoma leak, which involves the moisture-absorbent layer absorbing the leak, thereby reducing the electrical resistance between the two snap fasteners 4, 5. Further, when the moisture-absorbent layer is dry, the current between the two snap fasteners 4, 5 will be zero or approximately zero. As such, the potential difference measured between the two snap fasteners is zero or approximately zero. When the moistureabsorbent layer 3 becomes wet, as the result of a leak, for example, the potential difference between the two snap fasteners increases when the circuit is established and current flows between the two snap fasteners 4, 5. The comparator can determine when there has been a change in potential difference past a threshold value, and the alarm may be then be triggered.

[0043] Figure 4 shows a schematic of the snap fasteners 4, 5 and sensing unit 19. The sensing unit 19 comprises a power source 30 and a comparator 31. The sensing unit 19 may comprise an alarm 32 or transmitter 33 or both. The transmitter 33 may function to transmit data obtained by the comparator 31 to a receiver (not shown). The receiver may then trigger an alarm, for example, on a smartphone or table, to alert the wearer of a leak. The sensing unit 19 may comprise a processor 34 for processing data from the comparator 31. The processor 34 may be operably connected to the transmitter 33, alarm 32 or both. The processor 34 may function to trigger the alarm 32 or transmit data via the transmitter 33.

[0044] Optionally, the sensing unit 19 is capable of transmitting a signal to a further device, wherein the further device is capable of providing an alarm when a change in electrical resistance, potential difference, or both, is detected. The further device may be a smartphone, for example. The sensing unit may have a means for connecting the sensing unit to a wearer, such as an adhesive backing or hook-and-loop type backing. The moisture-absorbent layer 3 may have an adhesive backing to enable it to be stuck to a wearers skin around a stoma.

[0045] In use, the moisture-absorbent layer 3 or the leak detection device 1 , which may be part of an ostomy bag baseplate, or it may be a baseplate extender, is placed on the skin adjacent to, around, or proximal to a stoma, using the adhesive backing. The sensing device 19, if not already connected, is then connected to the snap fasteners 4, 5, via the wires 20 and the sensing unit snap fasteners. The sensing unit 19 can be attached to the wearer. The sensing unit 19 has a power source and can be powered on and off. The sensing unit 19 is powered on and it thereby beginsdetecting the resistance between the two snap fasteners 4, 5 on the moistureabsorbent layer 3. When the resistance drops below a threshold value, for example, because there has been a stoma leak and the moisture-absorbent layer has absorbed moisture 25 from the leak, the sensing unit 19 provides an alarm to the wearer.

[0046] According to a second aspect of the invention there is provided a method of manufacturing the leak detection device 1. The method involves the steps of: i) providing the moisture-absorbent layer 3; ii) installing a first snap fastener 4 by positioning the moisture-absorbent layer 3 between a first component 12 and a second component 13 of the snap fastener 4; iii) pressing the first component 12 and the second component 13 together with the moisture-absorbent layer 3 therebetween, until the first component 12 and second component 13 have engaged and are retained extending through the moisture-absorbent layer 3; iv) installing a second snap fastener 5 that is spaced apart from the first snap fastener 4 on the moisture-absorbent layer 3, following steps ii) and iii) in relation to the first snap fastener 4; v) wherein the first and second snap fasteners 4, 5 may be installed simultaneously or consecutively.

[0047] Prior to step ii) a textile layer 16 is adhered to the moisture-absorbent layer 3. The method further comprises placing a cover 18 over the snap fastener 4, 5 at one side of the moisture-absorbent layer 3. Step iii) involves using a snap fastener plier tool to force the first and second components 12, 13 together. The method further comprises the step of treating one or both snap fasteners 4, 5 with plasma or lasers.

[0048] Where a range of values is provided, for example, concentration ranges, percentage ranges, or ratio ranges, it is understood that each intervening value, to the tenth of the unit of the lower limit, unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the described subject matter. The upper and lower limits of these smaller ranges may independently be included in thesmaller ranges, and such embodiments are also encompassed within the described subject matter, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the described subject matter.

[0049] It should be understood that the terms "a" and "an" as used above and elsewhere herein refer to "one or more" of the enumerated components. It will be clear to one of ordinary skill in the art that the use of the singular includes the plural unless specifically stated otherwise. Therefore, the terms “a,” “an” and “at least one” are used interchangeably in this application.

[0050] Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as size, weight, reaction conditions and so forth used in the specification and claims are to the understood as being modified in all instances by the term “about”. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present subject matter. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0051] Throughout the application, descriptions of various embodiments use "comprising" language; however, it will be understood by one of skill in the art, that in some instances, an embodiment can alternatively be described using the language "consisting essentially of or "consisting of."

Claims

CLAIMS1. A leak detection device for detecting a leak from an ostomy bag, the leak detection device comprising a moisture-absorbent layer and at least two spaced apart snap fasteners extending through the moisture-absorbent layer, the snap fasteners being electrically conductive.

2. The leak detection device of claim 1 wherein the snap fasteners may be male or female snap fasteners.

3. The leak detection device of claim 1 or claim 2 wherein part of each snap fastener is located at one side of the moisture-absorbent layer and a further part of each snap fastener is located at the opposing side of the moistureabsorbent layer.

4. The leak detection device of claim 3 wherein at least one of the snap fasteners comprises a first component located at one side of the moisture-absorbent layer and a second component located at the opposing side of the moistureabsorbent layer, wherein the first and second components are separate components that are connected to one another.

5. The leak detection device of claim 4 wherein the first component is adapted to receive a part of the second component and retain the second component thereto.

6. The leak detection device of claim 4 or claim 5 wherein the second component comprises a base and one or more connectors extending from the base, wherein the connectors are configured to engage with the first component and be retained by the first component.

7. The leak detection device of claim 6 wherein the one or more connectors are spikes.

8. The leak detection device of claim 6 or claim 7 wherein the base is annular.

9. The leak detection device of any preceding claim wherein the moistureabsorbent layer is a hydrocolloid layer.

10. The leak detection device of any preceding claim further comprising a textile layer disposed directly or indirectly on the moisture-absorbent layer, and wherein the snap fasteners extend through the textile layer.

11. The leak detection device of claim 10 wherein the textile layer comprises an adhesive backing that adheres the textile layer to the moisture-absorbent layer.

12. The leak detection device of any preceding claim wherein a cover extends over the snap fastener at one side of the moisture-absorbent layer.

13. The leak detection device of any preceding claim wherein the snap fastener is formed from carbon composite.

14. The leak detection device of claim 13 wherein the snap fastener has been treated with plasma or lasers.

15. The leak detection device of any preceding claim wherein the leak detection device is integrally formed with an ostomy bag baseplate, or the leak detection device is a baseplate extender.

16. The leak detection device of any preceding claim further comprising a sensing unit for sensing a leak, the sensing unit being connected to or connectable to the snap fasteners.

17. The leak detection device of claim 16 wherein the sensing unit is capable of detecting when there is a change in electrical resistance, potential difference, or both, between two or more of the snap fasteners.

18. The leak detection device of claim 17 wherein the sensing unit is capable of providing an alarm when a change in electrical resistance, potential difference, or both, is detected.

19. The leak detection device of claim 17 or claim 18 wherein the sensing unit is capable of transmitting a signal to a further device, wherein the further device is capable of providing an alarm when a change in electrical resistance, potential difference, or both, is detected.

20. A method of manufacturing a leak detection device for detecting a leak from an ostomy bag, comprising the steps of: i) providing a moisture-absorbent layer; ii) installing a first snap fastener by positioning the moisture-absorbent layer between a first component and a second component of the snap fastener; iii) pressing the first component and the second component together with the moisture-absorbent layer therebetween, until the first component and second component have engaged and are retained extending through the moisture-absorbent layer; iv) installing a second snap fastener that is spaced apart from the first snap fastener on the moisture-absorbent layer, following steps ii) and iii) in relation to the first snap fastener; v) wherein the first and second snap fasteners may be installed simultaneously or consecutively.

21. The method of claim 20 wherein prior to step ii) a textile layer is adhered to the moisture-absorbent layer.

22. The method of claim 20 or claim 21 comprising placing a cover over the snap fastener at one side of the moisture-absorbent layer.

23. The method of any one of claims 20 to 22 wherein step iii) involves using a snap fastener plier tool to force the first and second components together.

24. The method of any one of claims 20 to 23 wherein one or both snap fasteners are formed from carbon composite.

25. The method of claim 24 further comprising the step of treating one or both snap fasteners with plasma or lasers.

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