WO2012126507A1 - System for monitoring faecal incontinence - Google Patents

System for monitoring faecal incontinence Download PDF

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Publication number
WO2012126507A1
WO2012126507A1 PCT/EP2011/054205 EP2011054205W WO2012126507A1 WO 2012126507 A1 WO2012126507 A1 WO 2012126507A1 EP 2011054205 W EP2011054205 W EP 2011054205W WO 2012126507 A1 WO2012126507 A1 WO 2012126507A1
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WO
WIPO (PCT)
Prior art keywords
gas
sanitary article
sensor
backsheet
permeable
Prior art date
Application number
PCT/EP2011/054205
Other languages
French (fr)
Inventor
Mattias Bosaeus
Allan ELFSTRÖM
Original Assignee
Sca Hygiene Products Ab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sca Hygiene Products Ab filed Critical Sca Hygiene Products Ab
Priority to PCT/EP2011/054205 priority Critical patent/WO2012126507A1/en
Publication of WO2012126507A1 publication Critical patent/WO2012126507A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/42Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with wetness indicator or alarm
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/44Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with radio-opaque material or signalling means for residual material

Definitions

  • the present invention relates to a system for monitoring faecal incontinence, in particular to a system comprising a diaper and a hydrogen gas .sensor attached thereto as well as to a diaper specifically adapted for chat purpose.
  • the detection technique proposed relies on the gasses effectively arriving from the patient's genital or anorectal area to the sensor, which is often unreliable with the mentioned faecal gases, firstly because not all people produce hydrogen sulphide and its organic acid in quantities sufficient to warrant detection, and secondly because these gases may remain trapped in the diaper, or simply not reach the device if fastened far from the body, such as on the bed.
  • a system for monitoring faecal incontinence comprising: a wearable sanitary article substantially conforming to the genital and/or anal body region of a wearer, a hydrogen gas sensor provided at an attachment area on [a backsheet of] the sanitary article faecal voiding zone, wherein the sensor comprises a gas inlet that is in gaseous communication with a faecal voiding zone of the sanitary article, and a signalling device adapted to emit a signal when the sensor detects a hydrogen concentration above a predetermined threshold.
  • the system of the invention achieves excellent faeces detection by as it concentrates on hydrogen gas that is virtually always present in faeces, and in contrast to carbon dioxide or nitrogen (also present in faeces in relevant quantities) allows to better distinguish against false readings and background, given that its concentration in ambient air is only about 0.00006% while in faeces it may compose up to 19% of the gaseous constituents.
  • the threshold H 2 concentration setting for triggering a signal or an alarm does not need to be set too close to the background level, making detection more reliable.
  • the sensor can capture a sufficient amount of hydrogen gas for detection before the highly volatile gas escapes the sanitary article. As soon as faecal discharge has occurred, the sensor detects the presence of hydrogen gas associated therewith (concentration above threshold) and instructs the signalling device to emit a signal alerting the
  • gaseous communication means that the targeted hydrogen gas is able to penetrate from the area of its occurrence at the faecal voiding zone to the gas inlet of the sensor without its concentration falling below a detection
  • gaseous communication may be, for example, achieved by suitable choice of materials between the faecal voiding zone and the gas inlet, which may prevent the hydrogen gas from dispersing too quickly due to its volatile nature.
  • sensor may comprise, apart from the physical probe detecting the H 2 gas, also associated control electronics and a power supply.
  • the faecal voiding zone is to be understood as that area of the wearable sanitary article which substantially corresponds to the anorectal region of the wearer, and which will generally lie in close proximity thereto when the sanitary article is worn. It can be seen as surface target
  • the exact position of the anorectal region may vary, but that the faecal voiding zone is predetermined during production of the sanitary article so as to correspond to the average anatomy of the intended target group.
  • the wearable sanitary article may for example be a diaper, nappy, incontinence insert, incontinence mat or the like which in use is in proximity to or comes in contact with a person's anorectal area.
  • the sensor may be included in a housing or box, together with control electronics, microprocessors and the signalling device, to form a sensor device which may be completely reusable, and contain no disposable parts.
  • the sanitary article may comprise a conduit leading from the faecal voiding zone to the gas inlet.
  • a conduit leading from the faecal voiding zone to the gas inlet may be provided away therefrom at a location chosen for maximum comfort, such as the front area of the sanitary article.
  • the conduit - made of suitably dense material having low permeability for H 2 - leads the gas to the sensor without a significant decrease in its concentration and, thus, loss of signal. This allows for highly reliable
  • the sanitary article comprises a gas -permeable backsheet and the gas inlet is disposed at or near the faecal voiding zone.
  • Near means that the faecal voiding zone and the gas inlet will both be at the anatomically bottom part of the sanitary article, e.g. both in the crotch are thereof. It also
  • gas inlet includes situations in which the gas inlet is positioned at the wearer's front pubic zone on the sanitary article, and in general means all locations of the gas inlet with respect to the faecal voiding zone where hydrogen gas released at the faecal voiding zone will reach the gas inlet in
  • the sanitary article comprises a gas - impermeable backsheet with a gas -permeable opening provided therein, and wherein the gas inlet is arranged at said opening.
  • gas- impermeable is to be understood as impermeable to faecal gases but at most letting only a negligible amount of hydrogen gas diffuse through the backsheet during a detection time. This is because molecular hydrogen, the most volatile gas in the periodic system due to its extremely small molecular radius, will diffuse through most materials except some metals, and thus will also diffuse through "gas- impermeable" backsheets, albeit very slowly.
  • gas- permeable means that gases, and certainly hydrogen, will diffuse through with at least an order of magnitude smaller time constants than through the gas - impermeable layer. It is to be observed that the gas-permeable opening may simply be a hole, but also an opening covered with a gas -permeable material such as a breathable non-woven.
  • the sanitary article comprises a bi-laminate backsheet having a gas - impermeable layer with a gas-permeable opening provided therein and an gas -permeable layer bonded to the gas- impermeable layer.
  • This configuration allows for accurate control of the hydrogen gas diffusion in that the hydrogen gas is led to the opening which thus, the sensing area of choice.
  • the bi-laminate can be manufactured in-line by punching a hole in the gas - impermeable material layer and then bonding it to the gas -permeable material layer. This additionally increases the containment time of the hydrogen gas in the sanitary article, allowing for even more reliable and accurate detection.
  • the senor comprises a clip by which it is attached to the sanitary article.
  • the sensor and its associated control electronics
  • the sanitary article and the sensor comprise matching parts of a hook-and-loop fastener for attaching the sensor to the sanitary article. This allows for precise positioning of the sensor on the sanitary article because a loop (or hook) pad may be provided in the correct position (attachment area) on the sanitary article, and the matching loop (or hook) pad may be provided on the sensor, thus facilitating precise overlap.
  • the signalling device is an acoustic signalling device. This is a basic configuration which is cheap to manufacture and is suitable for environments, such as home use, where the acoustic signal can be heard easily throughout .
  • the signalling device is a wireless transmitter
  • the system further comprises a receiver for receiving and reproducing the signal from the transmitter.
  • This configuration allows true remote monitoring of faecal incontinence, also over large distances according to the wireless technology used (short-range radio, Wi-Fi, cellular phone networks etc.) .
  • the receiver may be
  • faecal incontinence data e.g. time, frequency
  • the gas -permeable backsheet material is a breathable textile backsheet.
  • a breathable textile backsheet examples of such a material are a plastic film treated to have larger micropores, in
  • the invention provides a wearable sanitary article substantially conforming to the genital and/or anal body region of a wearer and having a faecal voiding zone, comprising a backsheet having an
  • attachment area for a hydrogen sensor device, wherein all or a part of the attachment area is gas -permeable and comprises fastening means for fastening said hydrogen sensor device.
  • the wearable sanitary article allows hydrogen gas created in the faecal voiding zone to preferentially pass directly to a hydrogen gas sensor attachable thereto. Moreover, by also providing means for fastening in the attachment area, the sensor can be accurately positioned where the hydrogen gas diffuses out of the sanitary article. This greatly increases measurement accuracy and reliability of the sensor, as compared to a case where no such provisions are effected in a common sanitary article. In addition, the mentioned configuration of the wearable sanitary article does not necessitate large
  • the backsheet is a bi-laminate comprising an inner gas- impermeable layer with a gas-permeable opening provided in correspondence with the attachment area and an outer gas -permeable layer bonded to the inner layer.
  • this configuration allows for accurate control of the hydrogen gas diffusion in that the hydrogen gas is led to the opening and, thus, the sensing area of choice.
  • the bi-laminate can be manufactured in-line by punching a hole in the gas - impermeable material layer and then bonding it to the gas -permeable material layer. This additionally increases the containment time of the hydrogen gas in the sanitary article, allowing for even more reliable and accurate detection.
  • the backsheet is gas- impermeable except for all or a part of the attachment area and comprises a conduit from the faecal voiding zone to the attachment area.
  • the conduit - made of suitably dense material having low permeability for H 2 - leads the gas to the sensor without a significant decrease in its
  • the attachment area is a pad made as one half of a hook-and- loop fastener. This allows for precise positioning of the sensor on the sanitary article because a loop (or hook) pad may be provided in the correct position (attachment area) on the sanitary article, and the matching loop (or hook) pad may be provided on the sensor, thus facilitating precise overlap.
  • Figure 1 shows a schematic perspective view ( Figure la) of an embodiment of the system for monitoring faecal incontinence according to the invention, comprising a diaper, sensor and receiver, as well as a sectional view through the diaper (Figure lb ⁇ emphasizing the diffusion of hydrogen gas in a diaper having a regular breathable backsheet;
  • Figure 2 shows a schematic perspective view ( Figure 2a) of another embodiment of the system for monitoring faecal incontinence according to the invention comprising diaper having a modified backsheet, as well as a sectional view through the diaper (Figure 2b) emphasizing the- diffusion of hydrogen gas in a diaper having a bi-laminate backsheet; and
  • Figure 3 shows a schematic view of a production step of the bi-laminate backsheet of the invention.
  • Figure la shows an embodiment of a system 1 for monitoring faecal incontinence, consisting of a diaper 10 (as one example of a wearable sanitary article), a sensor device 20, and a mobile receiver 30 such as a dedicated hand-held device, PDA or mobile phone.
  • the diaper comprises on its outer surface a breathable, i.e. gas -permeable backsheet 12 on which an attachment area 11 is visually indicated, for example by colouring the attachment area or marking its periphery.
  • a logo may optionally be provided in the
  • a faecal voiding zone 15 is indicated by a dashed line.
  • the gas-permeable backsheet 12 is, in this embodiment, a breathable textile backsheet having an area weight of 28 g/m 2 .
  • the breathable backsheet is made by laminating a cast microporous ⁇ film (14 g/m 2 ) filled with CaC0 3 and a non- woven (12-13 g/m 2 ) with 1-2 g/nf of glue. The backsheet thus obtained achieves a water vapour transmission rate of
  • the sensor device 20 comprises an housing 21, made for example of rigid material but may be made soft to the touch for more user comfort, such as by coating with a thermoplastic elastomer.
  • a tin-oxide hydrogen sensor (not shown ⁇ is arranged within the housing and connected to a gas inlet or sensing area 22 provided in a wall of the housing 21.
  • Other types of hydrogen sensor such as electrochemical sensors, may be used.
  • the sensor is electrically connected to a microprocessor that reads out and controls the sensor and is adapted to wirelessly send signals S through a transmitter (antenna) to the mobile receiver 30. Any suitable wireless communications hardware and protocols may be used according to the circumstances, such as WLAN, dedicated radio, SMS via mobile cellular networks etc.
  • a battery to power the components .
  • the sensor device 20 is attached to the diaper's attachment area 11 via a hook-and-loop pad 23 (e.g. bearing the "hook” - layer) provided on the gas inlet-side of the housing 21 and which cooperates with a matching hook-and-loop pad 24 (e.g. bearing "loop” ⁇ layer) on the attachment area.
  • a hook-and-loop pad 23 e.g. bearing the "hook” - layer
  • a matching hook-and-loop pad 24 e.g. bearing "loop” ⁇ layer
  • the microprocessor sends a wireless signal S to the mobile receiver 30 of the care personnel, which may for example emit an audible alarm and/or give a visual indication on its display.
  • the mobile receiver 30, or the sensor . device 20 itself, may also
  • the diaper 100 comprises a hydrogen gas - impermeable backsheet 112 that is provided, on the front side of the diaper, with a gas- permeable area 120.
  • the hydrogen gas penetrates the top sheet 114 and enters the core 113 of the diaper 100.
  • the hydrogen gas diffuses along the backsheet 112 until a significant fraction of high concentration reaches the gas -permeable area 120 of the backsheet 112. The hydrogen gas diffuses through the gas- permeable area 120 and toward the gas inlet 22.
  • the gas permeable area 120 is preferably adapted in size to the gas inlet 22 of the sensor, and positioned in the attachment area 111 so that upon proper overlap of sensor device 20 (gas inlet side of housing 21 ⁇ the gas permeable area 120 is aligned with gas inlet 22 (indicated by a dashed line in figure 2b) .
  • Figure 3 shows a particularly preferred embodiment, in which the backsheet 212 is a bi-laminate (or two layer laminate) of a gas - impermeable layer 212a with a hole (gas -permeable opening) 220 provided therein and an gas-permeable layer 212b bonded to the gas-impermeable layer 212a (see Figure 3a) .
  • the gas will diffuse along the gas impermeable layer 212a until it reaches the hole 220, through which it exits to penetrate the gas -permeable layer 212b.
  • the bi-laminate backsheet 212 may be manufactured inline by feeding the layer material from forming heads 240 and 250, punching the hole into the gas- impermeable layer 212a, and combining the layers 212a, 212b by gluing or other means of laminating ( Figure 3b) .
  • the bi-laminate backsheet 212 may for example be made by combining film material and non-woven material, with the non- woven material not being required for the function but added to give a more textile-like feeling.

Abstract

A system (1) is provided for monitoring faecal incontinence, comprising a wearable sanitary article (10, 100) substantially conforming to the genital and/or anal body region of a wearer, a hydrogen gas sensor (20) removably provided at an attachment area (11, 111) on [a backsheet of] the sanitary article, wherein the sensor comprises a gas inlet (22) that is in gaseous communication with a faecal voiding zone (15, 115) of the sanitary article, and a signalling device adapted to emit a signal (S) when the sensor detects a hydrogen concentration above a predetermined threshold. Also, a wearable sanitary article (10, 100) is provided, substantially conforming to the genital and/or anal body region of a wearer and having a faecal voiding zone (15, 115), comprising a backsheet (12, 112, 212) having an attachment area (11, 111) for a hydrogen sensor device (20), wherein the attachment area is gas-permeable and comprises fastening means (24) for fastening said hydrogen sensor device.

Description

System for monitoring faecal incontinence
The present invention relates to a system for monitoring faecal incontinence, in particular to a system comprising a diaper and a hydrogen gas .sensor attached thereto as well as to a diaper specifically adapted for chat purpose.
Background
In patient care, especially with elderly or immobilized patients, it is of great importance to maintain bodily hygiene in order to avoid skin conditions such as irritation or rash which may develop within hours into wounds that are difficult to heal. A particular issue arises when such patients are incontinent, that is unable to control urination and defecation by themselves, and thus need to wear a diaper. However, while urine can nowadays be reasonably well handled by advances in the absorbent materials of -which the diaper is made, which avoid rewetting of the patient's skin, no such technology is available against soiling by faeces, and the only remedy is for the care personnel to quickly identify faecal voiding and change the diaper.
This can be difficult when a great number of patients is cared for, such as in care home or hospital settings, and especially if patients cannot notify their carers themselves. In such situations, diaper rash or pressure ulcers can occur because the urine or faecal insult contacts the patient's skin for a prolonged period of time. Of course, similar circumstances also hold with infants that are not always crying when the nappy is soiled, or which cry but are not heard straight away.
Prior Art In order to address this kind of problem, body waste
detection systems have been developed which rely on the detection of gases contained in urine or faecal matter, such as the device known from US 5,709,222, which externally attaches via a clip to a patient's bed, clothing or diaper and comprises a sensor to detect the presence of urine gas and ammonia for urine, and hydrogen sulphide and hydrogen sulphide organic acid gas for faeces. If the target gasses are above a detection threshold for a certain amount of time, an alarm is sounded for the care personnel to hear, or a radio signal is sent out to a receiver stationed with the care personnel. However, the detection technique proposed relies on the gasses effectively arriving from the patient's genital or anorectal area to the sensor, which is often unreliable with the mentioned faecal gases, firstly because not all people produce hydrogen sulphide and its organic acid in quantities sufficient to warrant detection, and secondly because these gases may remain trapped in the diaper, or simply not reach the device if fastened far from the body, such as on the bed.
In clinical studies of infant faeces, such as the one
reported in T. Jiang et al . , uGas Production by Feces of Infants", J. Pediatr. Gastroenterol. Nutr., Vol. 32, No .5 , May 2001, pp. 534-541, it has in fact been found that certain gases commonly known to be associated with faeces, such as methane, are not produced by all subjects, and some gases such as hydrogen sulphide, vary widely in their
concentration, which thus makes them problematic targets for a reliable faeces detection. However, types of gas that are always present were shown to be carbon dioxide and hydrogen.
An odour-based incontinence sensor is proposed in the paper by Huadong Wu and Mel Siegel, "Odor-based Incontinence
Sensor", Proceedings of the 17th IEEE Instrumentation and Measurement Conference, pp. 63-68, 2000. In this case, several odoriferous gases characteristic of faeces, such as idole, skatole or hydrogen sulphide, were measured by solid- state tin-oxide sensors. However, no indication is given as to how detection of faecal matter is effected practical situations, such as with elderly incontinent people in a care home .
Thus, it emerges that although solutions for identifying faecal incontinence based on sensing odoriferous gases exist, these have several shortcomings in their applicability to different patients and in their reliability. Moreover, although hydrogen was identified as reliably present
constituent gas of faeces, its highly volatile nature has hitherto prevented the development of detection devices for measuring faecal incontinence.
Summary of the invention
In view of the above limitations of known prior-art
incontinence detection devices, it is an object of the invention to provide a system for monitoring faecal
incontinence, as well as a wearable sanitary article for use therewith, which allow to reliably detect faecal matter, are comfortable to wear and allow to advise the care personnel immediately of the presence of faecal matter. Such a system is defined in claim 1, while such a wearable sanitary article is defined in claim 11. Preferred embodiments are defined in the dependent claims .
According to the invention, there is provided a system for monitoring faecal incontinence, comprising: a wearable sanitary article substantially conforming to the genital and/or anal body region of a wearer, a hydrogen gas sensor provided at an attachment area on [a backsheet of] the sanitary article faecal voiding zone, wherein the sensor comprises a gas inlet that is in gaseous communication with a faecal voiding zone of the sanitary article, and a signalling device adapted to emit a signal when the sensor detects a hydrogen concentration above a predetermined threshold.
The system of the invention achieves excellent faeces detection by as it concentrates on hydrogen gas that is virtually always present in faeces, and in contrast to carbon dioxide or nitrogen (also present in faeces in relevant quantities) allows to better distinguish against false readings and background, given that its concentration in ambient air is only about 0.00006% while in faeces it may compose up to 19% of the gaseous constituents. Thus, the threshold H2 concentration setting for triggering a signal or an alarm does not need to be set too close to the background level, making detection more reliable. Moreover, by having a gas inlet in gaseous communication with the faecal voiding area, the sensor can capture a sufficient amount of hydrogen gas for detection before the highly volatile gas escapes the sanitary article. As soon as faecal discharge has occurred, the sensor detects the presence of hydrogen gas associated therewith (concentration above threshold) and instructs the signalling device to emit a signal alerting the
wearer/patient or a care taker that the sanitary article needs to be changed and the wearer/patient cleaned. In this way, it is possible to reliably avoid skin illnesses
associated with prolonged exposure to faeces, in particular in hospital or care home settings whe large number of patients are cared for by a limited number of personnel, and in particular for example at night when very few carers are present and patients are even less able to notice
incontinence since they are asleep.
Here, gaseous communication means that the targeted hydrogen gas is able to penetrate from the area of its occurrence at the faecal voiding zone to the gas inlet of the sensor without its concentration falling below a detection
threshold. Thus, gaseous communication may be, for example, achieved by suitable choice of materials between the faecal voiding zone and the gas inlet, which may prevent the hydrogen gas from dispersing too quickly due to its volatile nature. It is to be further noted that sensor may comprise, apart from the physical probe detecting the H2 gas, also associated control electronics and a power supply.
The faecal voiding zone is to be understood as that area of the wearable sanitary article which substantially corresponds to the anorectal region of the wearer, and which will generally lie in close proximity thereto when the sanitary article is worn. It can be seen as surface target
specifically for the wearer's anorectal area. However, due to the varying anatomy between different wearers it is to be understood that the exact position of the anorectal region may vary, but that the faecal voiding zone is predetermined during production of the sanitary article so as to correspond to the average anatomy of the intended target group.
The wearable sanitary article may for example be a diaper, nappy, incontinence insert, incontinence mat or the like which in use is in proximity to or comes in contact with a person's anorectal area.
The sensor may be included in a housing or box, together with control electronics, microprocessors and the signalling device, to form a sensor device which may be completely reusable, and contain no disposable parts.
The sanitary article may comprise a conduit leading from the faecal voiding zone to the gas inlet. In this manner, it is possible to limit wearing discomfort possibly caused by providing the sensor at the sanitary article close to the faecal voiding zone, since the conduit allows the sensor to be provided away therefrom at a location chosen for maximum comfort, such as the front area of the sanitary article. In addition, the conduit - made of suitably dense material having low permeability for H2 - leads the gas to the sensor without a significant decrease in its concentration and, thus, loss of signal. This allows for highly reliable
detection and exclusion of background or spurious events
In a preferred embodiment, the sanitary article comprises a gas -permeable backsheet and the gas inlet is disposed at or near the faecal voiding zone. The term "near" as used herein means that the faecal voiding zone and the gas inlet will both be at the anatomically bottom part of the sanitary article, e.g. both in the crotch are thereof. It also
includes situations in which the gas inlet is positioned at the wearer's front pubic zone on the sanitary article, and in general means all locations of the gas inlet with respect to the faecal voiding zone where hydrogen gas released at the faecal voiding zone will reach the gas inlet in
concentrations detectable by the sensor and distinguishable from background noise. This configuration allows for highly reliable detection due to the proximity of the gas inlet to the zone of creation of the hydrogen gas. Also, diffusion through the gas-permeable backsheet is a slower process than diffusion in air which would lead to the hydrogen
disappearing (getting below the detection limit) in less than 1 minute. Moreover, such backsheets are commonly produced so that only the attachment area needs to be provided during production (for instance by marking) , thus keeping costs low.
In an alternative embodiment, the sanitary article comprises a gas - impermeable backsheet with a gas -permeable opening provided therein, and wherein the gas inlet is arranged at said opening. Thus, hydrogen occurring at the faecal voiding zone cannot immediately diffuse away through the backsheet but will penetrate it in significant amounts only at the gas- permeable opening, leading directly to the gas inlet of the sensor. This allows highly reliable detection without
requiring complicated modification of the backsheet as only a gas -permeable opening needs to be provided additionally. Here, gas- impermeable is to be understood as impermeable to faecal gases but at most letting only a negligible amount of hydrogen gas diffuse through the backsheet during a detection time. This is because molecular hydrogen, the most volatile gas in the periodic system due to its extremely small molecular radius, will diffuse through most materials except some metals, and thus will also diffuse through "gas- impermeable" backsheets, albeit very slowly. Of course, gas- permeable means that gases, and certainly hydrogen, will diffuse through with at least an order of magnitude smaller time constants than through the gas - impermeable layer. It is to be observed that the gas-permeable opening may simply be a hole, but also an opening covered with a gas -permeable material such as a breathable non-woven.
In a particularly preferred embodiment of the invention, the sanitary article comprises a bi-laminate backsheet having a gas - impermeable layer with a gas-permeable opening provided therein and an gas -permeable layer bonded to the gas- impermeable layer. This configuration allows for accurate control of the hydrogen gas diffusion in that the hydrogen gas is led to the opening which thus, the sensing area of choice. The bi-laminate can be manufactured in-line by punching a hole in the gas - impermeable material layer and then bonding it to the gas -permeable material layer. This additionally increases the containment time of the hydrogen gas in the sanitary article, allowing for even more reliable and accurate detection.
Preferably, in the system of the invention, the sensor comprises a clip by which it is attached to the sanitary article. Thus, no modification of the sanitary article is necessary for efficient fixation, and production costs thereof can be kept low. Moreover, the sensor (and its associated control electronics) can be reusable, and detached from the sanitary article upon changing it. Alternatively, the sanitary article and the sensor comprise matching parts of a hook-and-loop fastener for attaching the sensor to the sanitary article. This allows for precise positioning of the sensor on the sanitary article because a loop (or hook) pad may be provided in the correct position (attachment area) on the sanitary article, and the matching loop (or hook) pad may be provided on the sensor, thus facilitating precise overlap.
In one embodiment, the signalling device is an acoustic signalling device. This is a basic configuration which is cheap to manufacture and is suitable for environments, such as home use, where the acoustic signal can be heard easily throughout .
In a more preferred embodiment, the signalling device is a wireless transmitter, and the system further comprises a receiver for receiving and reproducing the signal from the transmitter. This configuration allows true remote monitoring of faecal incontinence, also over large distances according to the wireless technology used (short-range radio, Wi-Fi, cellular phone networks etc.) . The receiver may be
incorporated into existing infrastructure at the place of use (e.g. nursing home) and be connected to personal computers for monitoring and evaluation of the faecal incontinence data (e.g. time, frequency) .
Preferably, the gas -permeable backsheet material is a breathable textile backsheet. Examples of such a material are a plastic film treated to have larger micropores, in
particular a PE film treated with CaCO3, but other materials and treatment techniques can be used to obtain the same result. This material is an optimum compromise between containment of the hydrogen gas, on the one hand, and letting enough gas through to the gas inlet for reliable detection by the sensor. According to another aspect, the invention provides a wearable sanitary article substantially conforming to the genital and/or anal body region of a wearer and having a faecal voiding zone, comprising a backsheet having an
attachment area for a hydrogen sensor device, wherein all or a part of the attachment area is gas -permeable and comprises fastening means for fastening said hydrogen sensor device.
By providing a gas -permeable attachment area the wearable sanitary article allows hydrogen gas created in the faecal voiding zone to preferentially pass directly to a hydrogen gas sensor attachable thereto. Moreover, by also providing means for fastening in the attachment area, the sensor can be accurately positioned where the hydrogen gas diffuses out of the sanitary article. This greatly increases measurement accuracy and reliability of the sensor, as compared to a case where no such provisions are effected in a common sanitary article. In addition, the mentioned configuration of the wearable sanitary article does not necessitate large
investments in production as it can be manufactured in traditional manufacturing lines with little or no adaptation to the lines themselves.
In a particularly preferred embodiment, the backsheet is a bi-laminate comprising an inner gas- impermeable layer with a gas-permeable opening provided in correspondence with the attachment area and an outer gas -permeable layer bonded to the inner layer. As mentioned above, this configuration allows for accurate control of the hydrogen gas diffusion in that the hydrogen gas is led to the opening and, thus, the sensing area of choice. The bi-laminate can be manufactured in-line by punching a hole in the gas - impermeable material layer and then bonding it to the gas -permeable material layer. This additionally increases the containment time of the hydrogen gas in the sanitary article, allowing for even more reliable and accurate detection. Alternatively, the backsheet is gas- impermeable except for all or a part of the attachment area and comprises a conduit from the faecal voiding zone to the attachment area. In this manner, it is possible lead away the hydrogen gas from the faecal voiding zone and, thus, the anorectal area be detected at a location where positioning a hydrogen gas sensor does not cause discomfort, such as the front area of the sanitary article. In addition, the conduit - made of suitably dense material having low permeability for H2 - leads the gas to the sensor without a significant decrease in its
concentration and, thus, loss of signal. This allows for highly reliable detection and exclusion of background or spurious events.
In a preferred embodiment, the attachment area is a pad made as one half of a hook-and- loop fastener. This allows for precise positioning of the sensor on the sanitary article because a loop (or hook) pad may be provided in the correct position (attachment area) on the sanitary article, and the matching loop (or hook) pad may be provided on the sensor, thus facilitating precise overlap.
Brief description of drawings
In the following, the invention will be described by
referring to the enclosed drawings which show, by way of example, a preferred embodiment of the invention:
Figure 1 shows a schematic perspective view (Figure la) of an embodiment of the system for monitoring faecal incontinence according to the invention, comprising a diaper, sensor and receiver, as well as a sectional view through the diaper (Figure lb} emphasizing the diffusion of hydrogen gas in a diaper having a regular breathable backsheet; Figure 2 shows a schematic perspective view (Figure 2a) of another embodiment of the system for monitoring faecal incontinence according to the invention comprising diaper having a modified backsheet, as well as a sectional view through the diaper (Figure 2b) emphasizing the- diffusion of hydrogen gas in a diaper having a bi-laminate backsheet; and
Figure 3 shows a schematic view of a production step of the bi-laminate backsheet of the invention.
Detailed description
Figure la) shows an embodiment of a system 1 for monitoring faecal incontinence, consisting of a diaper 10 (as one example of a wearable sanitary article), a sensor device 20, and a mobile receiver 30 such as a dedicated hand-held device, PDA or mobile phone. The diaper comprises on its outer surface a breathable, i.e. gas -permeable backsheet 12 on which an attachment area 11 is visually indicated, for example by colouring the attachment area or marking its periphery. A logo may optionally be provided in the
attachment area 11. At the inside of the diaper, a faecal voiding zone 15 is indicated by a dashed line.
The gas-permeable backsheet 12 is, in this embodiment, a breathable textile backsheet having an area weight of 28 g/m2. The breathable backsheet is made by laminating a cast microporous ΡΞ film (14 g/m2) filled with CaC03 and a non- woven (12-13 g/m2) with 1-2 g/nf of glue. The backsheet thus obtained achieves a water vapour transmission rate of
3000 + 1500 g/m2/24 h.
The sensor device 20 comprises an housing 21, made for example of rigid material but may be made soft to the touch for more user comfort, such as by coating with a thermoplastic elastomer. A tin-oxide hydrogen sensor (not shown} is arranged within the housing and connected to a gas inlet or sensing area 22 provided in a wall of the housing 21. Other types of hydrogen sensor, such as electrochemical sensors, may be used. The sensor is electrically connected to a microprocessor that reads out and controls the sensor and is adapted to wirelessly send signals S through a transmitter (antenna) to the mobile receiver 30. Any suitable wireless communications hardware and protocols may be used according to the circumstances, such as WLAN, dedicated radio, SMS via mobile cellular networks etc. Also provided in the housing is a battery to power the components .
In use, the sensor device 20 is attached to the diaper's attachment area 11 via a hook-and-loop pad 23 (e.g. bearing the "hook" - layer) provided on the gas inlet-side of the housing 21 and which cooperates with a matching hook-and-loop pad 24 (e.g. bearing "loop" ~ layer) on the attachment area. Both pads 23 and 24 are gas -permeable , for example by
providing small holes in their supporting fabric. In this way, a gas communication is established between the inner side of the breathable backsheet 12 and the gas inlet 22 of the sensor in sensor device 20.
When faecal matter is discharged by the diaper's wearer onto the faecal voiding zone 15, hydrogen gas present in the faeces will rapidly diffuse through the topsheet 14 into the core 13 of the diaper and along the backsheet 12, diffusing through it (see arrows in Figure lb) . A part of the hydrogen gas penetrates the gas -permeable backsheet 12 at the
attachment area 11 and passes into the gas inlet 22 (onto the sensing area) of the hydrogen sensor. If the hydrogen
concentration in a given time (or the hydrogen flow rate) measured by the sensor and microprocessor is above a
predetermined threshold (set for example to a value suitable to distinguish from flatulence where hydrogen occurs and persists on much shorter timescales) , the microprocessor sends a wireless signal S to the mobile receiver 30 of the care personnel, which may for example emit an audible alarm and/or give a visual indication on its display. The mobile receiver 30, or the sensor . device 20 itself, may also
communicate with further infrastructure such as computers or databases present in the care environment (patient's home, hospital or nursing home) and exchange or otherwise provide incontinence data for diagnostic purposes or, in hospitals and nursing homes, for care plans or staffing.
In an alternative embodiment, shown in Figure 2, the diaper 100 comprises a hydrogen gas - impermeable backsheet 112 that is provided, on the front side of the diaper, with a gas- permeable area 120. In this case, as shown in detail in the lower right drawing of figure 2, when faecal matter is discharged onto the faecal voiding zone 115, the hydrogen gas penetrates the top sheet 114 and enters the core 113 of the diaper 100. However, due to the low permeability for hydrogen of the gas - impermeable layer, the hydrogen gas diffuses along the backsheet 112 until a significant fraction of high concentration reaches the gas -permeable area 120 of the backsheet 112. The hydrogen gas diffuses through the gas- permeable area 120 and toward the gas inlet 22. The gas permeable area 120 is preferably adapted in size to the gas inlet 22 of the sensor, and positioned in the attachment area 111 so that upon proper overlap of sensor device 20 (gas inlet side of housing 21} the gas permeable area 120 is aligned with gas inlet 22 (indicated by a dashed line in figure 2b) .
Figure 3 shows a particularly preferred embodiment, in which the backsheet 212 is a bi-laminate (or two layer laminate) of a gas - impermeable layer 212a with a hole (gas -permeable opening) 220 provided therein and an gas-permeable layer 212b bonded to the gas-impermeable layer 212a (see Figure 3a) . In use, the gas will diffuse along the gas impermeable layer 212a until it reaches the hole 220, through which it exits to penetrate the gas -permeable layer 212b. The bi-laminate backsheet 212 may be manufactured inline by feeding the layer material from forming heads 240 and 250, punching the hole into the gas- impermeable layer 212a, and combining the layers 212a, 212b by gluing or other means of laminating (Figure 3b) . The bi-laminate backsheet 212 may for example be made by combining film material and non-woven material, with the non- woven material not being required for the function but added to give a more textile-like feeling.

Claims

Claims
1. A system (1) for monitoring faecal incontinence,
comprising :
a wearable sanitary article (10, 100} substantially conforming to the genital and/or anal body region of a wearer,
a hydrogen gas sensor (20) removably provided at an attachment area (11, 111) on the sanitary article,
wherein the sensor comprises a gas inlet (22) that is in gaseous communication with a faecal voiding zone (15, 115) of the sanitary article, and
a signalling device adapted to emit a signal (S) when the sensor detects a hydrogen concentration above a
predetermined threshold.
2. The system of claim 1, wherein the sanitary article (10, 100) comprises a conduit leading from the faecal voiding zone (15, 115) to the gas inlet (22) .
3. The system of claim 1, wherein the sanitary article (10) comprises a gas -permeable backsheet (12) and the gas inlet (22) is disposed at or near the faecal voiding zone (15) .
4. The system of claim 1, wherein the sanitary article (100) comprises a gas-impermeable backsheet (112) with a gas- permeable opening (120) provided therein, and wherein the gas inlet (22) is arranged at said opening.
5. The system of claim 1, wherein the sanitary article (100) comprises a bi-laminate backsheet (212) having a gas- impermeable layer (212a) with a gas-permeable opening (220) provided therein and an gas-permeable layer (212b) bonded to the gas-impermeable layer.
6. The system of any of the preceding claims, wherein the sensor (20) comprises a clip by which it is attached to the sanitary article (10, 100).
7. The system of any of claims 1 to 5, wherein the sanitary article {10, 100) and the sensor (20) comprise matching parts (23, 24) of a hook-and- loop fastener for attaching the sensor to the sanitary article.
8. The system of any of the preceding claims, wherein the signalling device is an acoustic signalling device.
9. The system of any of claims 1 to 8 , wherein the
signalling device is a wireless transmitter, and the system further comprises a receiver (30) for receiving and
reproducing the signal (S) from the transmitter.
10. The system of any of claims 4 to 9, wherein the gas- permeable backsheet material (12) is a breathable textile backsheet .
11. A wearable sanitary article (10, 100) substantially conforming to the genital and/or anal body region of a wearer and having a faecal voiding zone (15, 115), comprising
a backsheet (12, 112, 212) having an attachment area (11, 111) for a hydrogen sensor device (20), wherein
all or part (120) of the attachment area (11, 111) is gas -permeable and comprises fastening means (24) for
fastening said hydrogen sensor device (20) .
12. The sanitary article of claim 11, wherein the backsheet (212) is a bi-laminate comprising an inner gas- impermeable layer (212a) with a gas -permeable opening (220) provided in correspondence with the attachment area (111) and an outer gas -permeable layer (212b) bonded to the inner layer.
13. The sanitary article of claim 11, wherein the backsheet (112) is gas - impermeable except for all or a part (120) of the attachment area (111) and comprises a conduit from the faecal voiding zone (115) to the attachment area (111).
14. The sanitary article of any of claims 11 to 13, wherein the attachment area (11, 111) is a pad (24) made as one half of a hook-and-loop fastener.
PCT/EP2011/054205 2011-03-21 2011-03-21 System for monitoring faecal incontinence WO2012126507A1 (en)

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