WO2014122169A1

WO2014122169A1 - Apparatus and system for non-invasive incontinence detection, analysis and transmission

Info

Publication number: WO2014122169A1
Application number: PCT/EP2014/052238
Authority: WO
Inventors: John Paul Kelly; Andrew Barr
Original assignee: I-Innovations Ltd.
Priority date: 2013-02-08
Filing date: 2014-02-05
Publication date: 2014-08-14
Also published as: GB2512575A; GB201302300D0; GB2512575B

Abstract

The present invention comprises a system for detecting and monitoring incontinence in a mammal, the system comprising: (a) means for detecting a gas associated with incontinence; (b) means for transmitting the detected gas level to a central controller; (c) means for comparison of the detected gas level with a pre-determined reference level; (d) means for transmitting a signal to a receiving device if the detected gas level is equal to or exceeds the reference level.

Description

APPARATUS AND SYSTEM FOR NON-INVASIVE INCONTINENCE DETECTION, ANALYSIS AND TRANSMISSION

The present invention relates to an apparatus, system and method for non-invasive incontinence detection, analysis and transmission.

Throughout this specification, in relation to the present invention, the term "incontinence" is to be understood as including both faecal and urinary incontinence. Furthermore, the term "soiling" is to be understood to refer to soiling by urine and soiling by faeces.

BACKGROUND TO THE INVENTION

There is a global increase in the strain associated with world health care economies. A key contributor to this increased strain is the 'aging population' and increase in care management that is associated with taking care of the elderly. A common care requirement associated with the aging population is incontinence care and continence promotion.

Incontinence, the inability to control one's urine or bowel movements, is most common among older people, those with dementia, and other faculty diminishing conditions. It is also a major driving force in long-term care admissions (Tariq, 2004). At least half of the elderly population within Britain's and North America's care homes suffer from incontinence (Offermans, et al., 2009).

Although care homes are often portrayed as a safe haven for our most vulnerable population, many authorities have dissented from the view that they are a continence- friendly environment (Lyons, 2009; DuBeau, 2005; Ouslander & Johnston, 2004; Offermans, et al., 2009).

When incontinence is not attended to, a person can experience degeneration of his/her skin health, making him/her prone to pressure ulcers and bedsores in regions of the body that remain in contact with the faecal matter or urine. Since many elderly individuals are incapacitated and cannot summon assistance, this means carers must be relied on to firstly detect and then respond promptly to the problem. As the proportion of older people increases worldwide and the number of care homes is increasing, there is the requirement for improved independent living assistive technology. Our current health economics models in the western world are trying to control staff to patient ratios, particularly as our ageing population is growing rapidly. It is important that in cases where technology is deemed robust, and if there are patient benefits as well as economic benefits, technological based models of enhancing care should be adopted.

Currently, in care homes, incontinence management relies on a manual process of checking for incontinence events, whereby it is the responsibility of a member of the nursing care team to detect the characteristic odour of diapers/pants that need to be changed. This can be difficult to monitor on a 24-hour basis particularly late at night or in remote parts of the care home. This can also result in a sense of reduced dignity for many suffers, especially those who still uphold many of their mental faculties.

Incontinence sensors as such are known in the prior art. Known prior art is based on bed wetting and involves capacitive or resistive monitoring although some publications refer to wireless technology. Known odour monitoring is focused on environmental monitoring of odour for poisonous/noxious gases. Known incontinence sensors for faecal incontinence are based on invasive anal passage monitoring. These involve EMG, or movement monitoring of nearby muscles.

A wide range of sensors exist for detecting wetting associated with urination, and EMG associated with muscle movements during bowel movement.

There are patent publications in the area of moisture detectors, muscle EMG assessment against bowel movements and certainly there are numerous publications relating to remote monitoring of bodily functions such as vital signs, blood and behavioral analysis.

The following publications demonstrate the state of the art in this field: US 5570082 (Remote wetness sensor for diapers) discloses a system for detecting wetness in diapers for the purpose of calling the attention of a carer/care assistant. The system is based on the nonlinear interaction of an implanted device inside the diaper with a low distortion background electromagnetic field. The background field is generated by a transmitter external to the diaper. The device is a combination of an antenna, a nonlinear element and two electrodes. Upon a wet condition, the resistance between the two electrodes decreases, resulting in an increase in coupling between the antenna and the nonlinear element. The ensuing nonlinear interaction between the antenna and the background field gives rise to harmonics of the field which are detected by a receiver. The receiver, which is also external to the diaper, triggers a suitable alarm.

US 5392032 (Apparatus for sensing wet diaper including circuit breaker) discloses a device for signaling a wet condition in a diaper. The device includes a sensing means for sensing wet conditions in the diaper and signal means connected to the sensing means for producing a signal substantially concurrently with sensing the wet conditions in the diaper. The sensing means are insulated from the wearer when the diaper is dry and are activated by the diaper once the diaper becomes wet.

US 20100010459 (Undergarment for incontinent person and treatment device connected to an undergarment) discloses an undergarment comprising a supporting part which surrounds at least the hips and the top of each thigh; and a flexible collecting bag positioned at the crotch.

WO 2004/034929 (Incontinence sensor) discloses a body fluid sensor for remote volume reading of the presence and volume of body fluids in a patient environment. In the sensor, a first layer provides support for and has on it a conductor pattern having at least a first electrode of at least a given length and a second electrode of at least said given length.

US 6464144 (Hand held terminal with an odour sensor) discloses a hand held terminal comprising a display, a keying input, an odour sensor, a processor for receiving information from the keying input and from the odour sensor for processing same and for directing information onto the display and a housing for the keying input, odour sensor, display and processor. The sensor makes use of the odour detection technology to detect volatile chemical compounds. This sensor uses an opto-electronic sensor array to identify specific olfactory patterns. It is reported that the sensor can detect, identify, and discriminate several airborne compounds such as toxic industrial chemicals and chemical warfare agents in two seconds.

SUMMARY OF THE PRESENT INVENTION

The present invention seeks to alleviate the disadvantages of the prior art. The present invention accordingly provides a system for detecting and monitoring incontinence in a mammal, the system comprising:

(a) means for detecting a gas associated with incontinence;

(b) means for comparison of the detected gas parameter with a pre-determined reference parameter; and

(c) means for transmitting a signal to a receiving device if the detected gas parameter is equal to or exceeds the reference parameter. Preferably, the system further comprises means of analytically distinguishing between soiling and flatulence based on based on at least one reference parameter, the at least one reference parameter comprising a gas level and/or predetermined specified gas behaviour. Advantageously, the system of the present invention also comprises a central controller, optionally in the form of a micro-controller, which is capable of operating an algorithm to compare the detected gas parameter with a pre-determined gas parameter and is adapted to transmit a signal to the receiving device if appropriate, having compared the detected gas parameter with the pre-determined gas parameter.

Advantageously, the system comprises means for displaying data associated with the transmitted signal data on display means of the system.

The detected gas is preferably ammonia and the means for detecting a gas comprises a sensing device capable of sensing the presence of ammonia. Preferably the sensing device is capable of sensing the presence of ammonia and more particularly, the sensing device is adapted to detect a pattern of the presence of ammonia associated with incontinence rather than flatulence. This pattern will be explained in more detail hereinbelow.

The system is configured to distinguish between the emissions profile (e.g. ammonia emissions profile) associated with a flatulence event and a soiling event, "soiling" referring to urine and faeces, in order to make an accurate detection of incontinence and not merely flatulence. The system further comprises means for enabling data to be automatically received or downloaded to the controller from a computer and/or via a network connection.

The data receiving or data presentation device preferably comprises a portable device such as a portable hand held device with an internet or web-browser connection.

The mammal is preferably a human.

The system of the present invention comprises a continuous non-invasive monitoring device that is adapted to detect, distinguish, log and transmit details of incontinence events wirelessly via a back end web based task management applications to a user via a hand held device with an internet or web-browser connection.

Thus, in another aspect, the present invention provides a method for monitoring and detecting levels of a diffused gas (e.g. ammonia) arising from a flatulence event or an incontinence event; the method including the steps of:

providing an algorithm, the algorithm being configured to compare the detected level of diffused gas with a predetermined parameter associated with diffused gas from an incontinence event;

- transmitting a signal if an increase above a baseline level of gas is detected, the signal being transmitted by wireless transmission, the wireless transmission preferably carried out using a proprietary 433 MHz broadcasting signal that communicates to wireless router and can also communicate via a back up of bluetooth as a failsafe back up that can enable the communication between the sensing device and user hand held devices;

preferably wherein the hand held devices are programmed with a backend software application which presents the transmitted information to a user user/carer that there has been an episode of incontinence, incontinence being human wetting or soiling, within a contextual setting of any of the following nursing home, new parent or any dependent in society.

The device for housing the sensor(s) is preferably in the form of a relatively small and inexpensive enclosure, preferably manufactured of polymeric material. The enclosure/housing is preferably specifically adapted for facilitating the operation of the sensor(s) of the present invention. The housing is configured to include vents through which air flow can enter into the sensor housing and preferably also includes a means for drawing air close to the region of the sensor to maximise opportunity for the sensor to detect the relevant market gas. Preferably the means for drawing in air into the housing comprises a fan.

In another aspect, the present invention provides a method comprising the further step of: sending a notification to a carer when the detected gas level is equal to or exceeds the reference level. In a further aspect, the present invention provides the use of analytical spectroscopy to analyse and profile the output of gases associated with human incontinence and flatulence.

In a further aspect, the present invention also provides the use of gas sensors in the system of the present invention.

The present invention also relates to the use of a gas sensing device combined with

a. wireless monitoring and

b. backend software

to present to the user/carer that there has been an episode of incontinence, incontinence being human wetting or soiling, within a contextual setting of any of the following nursing home, new parent or any dependent in society.

The wireless monitoring is carried out using a proprietary 433 MHz broadcasting signal that communicates to wireless router; and can also communicate via a back up of blue tooth as a failsafe back up that can enable the communication between the microcontroller and the user hand held devices.

In particular, the present invention provides the use of a gas sensor for specifically detecting levels of a diffused gas (e.g. ammonia) arising from a flatulence event or an incontinence event combined with an algorithm, the algorithm being configured to compare the detected level of diffused gas with a predetermined parameter associated with diffused gas from an incontinence event; and means to transmit a signal if an increase above a baseline level of gas is detected, the signal being transmitted by wireless transmission. The wireless monitoring is preferably carried out using a proprietary 433 MHz broadcasting signal that communicates to wireless router and can also communicate via a back up of blue tooth as a failsafe back up that can enable the communication between the sensing device and user hand held devices. Preferably, the hand held devices are programmed with a backend software application which presents the transmitted information to a user user/carer that there has been an episodes of incontinence, incontinence being human wetting or soiling, within a contextual setting of any of the following nursing home, new parent or any dependent in society.

In another aspect of the present invention, there is provided the use of an ammonia sensor combined with means for detecting an increase in ammonia above baseline level followed by a diffusion pattern of ammonia gas over a pre-determined period of time.

The system of the present invention including the sensor housing device are particularly advantageous for use in residential and skilled nursing homes to optimise the care of the elderly, especially those with Alzheimer's disease, Parkinson's disease or dementia, where incontinence is more regular.

The system ideally includes means for monitoring residents' environments and detecting a range of conditions which impact on the residents' safety and well being. These conditions are described in more detail hereinbelow.

In another aspect, the present invention provides a method of detecting and monitoring incontinence in a mammal, the method comprising the following steps:

(a) detecting a gas associated with incontinence;

(b) comparing the detected gas parameter with a pre-determined reference parameter; and

(c) transmitting a signal to a receiving device if the detected gas parameter is equal to or exceeds the reference parameter. Preferably, the method also comprises the step of transmitting a signal indicating the detected gas parameter to a central controller.

In summary, the present invention relates to a non-invasive remote ambient gas-sensing, appraising and transmitting device for the detecting of urine/wetting, faeces/soiling and flatulence activity. The system of the present invention has the means to distinguish between wetting, soiling and flatulence and therefore is capable of eliminating false positives, i.e. distinguishing between a flatulence event as opposed to a soiling event or an urination event. The system of the present invention has the advantage that it provides a remote and noninvasive means of monitoring patients for soiled or wet diapers. In nursing homes, for example, care staff are required to manually check residents for soiled or wet diapers; this can be time consuming and if not carried out frequently, can result in severe skin infections and expensive treatment programs. In contrast, the system of the present invention will non-invasively actually notify carers when a wet or soiled diaper is detected. Thus the system uses non-invasive detection means combined with wireless transmission and hand held devices to provide a technically advantageous solution.

The system enhances the standard of residential care by reducing the time that a patient needlessly resides in urine and feces, consequently reducing complications such as skin irritation, perianal dermatitis and skin ulcers. In addition, the system reduces and also optimises care duties by alerting carers when there is a problem, freeing them from having to check conditions needlessly. The system comprises a task management information system that functions as a central hub for alerts and data transmissions. The system enables the complete removal of the known paper based system of record keeping and provides a comprehensive health information system specifically tailored to the needs of residential and nursing homes. The system has the advantage that it empowers users by providing the user with the means to have around the clock wireless monitoring for health peripheral such as incontinence, humidity, and temperature in addition to enabling instant point of care recordings and management notifications thereby ensuring the most vulnerable within society are taken care of in a timely, dignified and empathetic manner.

The algorithm on which the system operates is based on a decision making process based on detecting levels and patterns of a marker gas; and operates in combination with the hardware which comprises the housing for the electronics devices, sensors and microcontroller. Point of Care Recordings & Task Management App (Informatics)

The system of the present invention also comprises an informatics system, bespoke to residential and nursing homes. The system of the present invention is ISO compatible and allows nursing home staff to log and update work rotas and residents' details electronically; this data can be seen and appraised by selected individuals. The data could then be used to (a) keep a record of events for audit purposes or review by family

(b) aid care staff to manage regimes, i.e. toiletry regimes by issuing reports or reminders,

(c) help with tracking fluid intake and possible resident dehydration by remotely prompting staff of unusually frequent episode of urination or allowing staff to manually log fluid intake of resident (e.g. 1 glass of water at 13:23).

Advantageous Technical Features provided by the present invention

• The specificity between light, moderate, heavy soiling and flatulence in relation to false positives/negatives results in attainability to produce a clear algorithm for threshold detection.

• The ability to create flow channels that allow small pumping of gas via an electrochemical sensor.

• Smart algorithmic coding to calculate differentials against normal backgrounds as continually been updated with the ambient environment. This leads to improved recording of data and higher selectivity for alarming.

• Power management is based on sampling rates. This means that smart, on-board processing sets intervals for sampling based on eating and sleeping habits, as well as the requirement for continuous monitoring at set times. This, in turn, saves battery power.

· The present system proposes to allow soiling frequencies, times, types to be monitored in order to allow for improved management of medicines, illness, nursing resource, clothing/bed linen management, in-house toilet times.

• The system utilises technology such as a microphone, thermometer and/or humidity sensor to create a holistic monitoring device.

· The system encompasses a comprehensive and intuitive task management application compatible with IOS devices and web accessible devices.

• In one embodiment, the system may link telemetry to positioning/accelerometer hardware (built-in to micro) software and also monitor distance, position and steps etc., thus allowing accuracy in detecting patient location. • In another embodiment, the system may include a fall indicator that utilises axial g- force created software.

DETAILED DESCRIPTION OF THE SYSTEM OF THE PRESENT INVENTION

The system of the present invention is based on the detection of a specific gas, which can be detected in exhaustible odours diffused from urine and/or faeces. The inventor has correlated key gaseous trends, behaviours and thresholds and devised a system to ensure accurate decision-making within the system of the present invention. Hardware netting and layering techniques have been used to reduce sensor noise and amplify output in order to augment sensor readings in real-times environment. This is of particular importance when in a nursing home setting where other gases will be profuse and in a state of constant flux.

Sensors have been developed which will activate, based on chemical reactions between the sensor elements and marker gas, when the marker gas has been detected. Control electronics condition the signals and send a radio message through a 433 MHz frequency in the first instance and bluetooth transmission is used to transfer a signal to user handheld devices as a failsafe back up transmissions. However, any wireless technology could be employed (e.g. a wifi stack) to alert a carer or parent that an event has occurred. All electronics have been enclosed in a specifically adapted casing designed to maximise airflow intake while reducing internal Pascal-pressure to cohere with the chosen sensors' optimal functional parameters.

In order to develop an appropriate user interface in the software/user application, a reputable skilled nursing home was used to enable a complete data capture encompassing a list of management variables; including (though not limited to) an entire breakdown of tasks, roles, responsibilities, guidelines, regulatory adherence. This data was then converted in parametric format coherent with necessary design inputs required to create an intuitive and user-friendly informatics system usable across numerous web- enabled platforms.

The developed software allows flexibility to ensure that individual customers can customise and set individual thresholds and agendas etc. However, it was also created to be rigid enough to adhere with QCC guidelines and ensure reviews and hard copy printouts can be produced. Incontinence Detection

The system of the present invention achieves the ability to non-invasively detect faeces or urine, using a gas detector for sensing a key marker gas, preferably ammonia.

The sensor used has been designed so that the gas supply is limited by diffusion and thus the output from the sensor is linearly proportional to the gas concentration. The linear output allows greater control over the measurement of low concentrations and much simpler calibration and cross referencing with preset standards.

To maximise operational distance between the sensing device and a dependent person who is prone to incontinence, a bespoke enclosure has been developed comprising angular vents and a fan, preferably, a mini biaxial fan. To minimise false positives and ensure sensor accuracy, the sensors housed in the enclosures have been capsulated with a polysynthetic that allows ambient air pass in only when a scan is being performed and adversely pump air out when a sensor flush is being performed.

Algorithm

The following describes the detection device (i.e. "sniffer") included in the system for detection of incontinence events.

The inventor has found that ammonia is a dominant component of gaseous excretions associated with urinary or faecal incontinence. The detection device comprises a gas sensor with its primary target gas for detection being ammonia (NH₃) gas. Additional findings from the applicant's research are that ammonia (NH₃) gas release appears to have two distinct characteristics:

The first is a sharp spike characteristic with an exponential decay as illustrated in Figure 6 of the accompanying drawings. Clearly, this pattern represents a rapid increase in the local concentration of NH₃ followed by the dissipation of the gas (in applicable case by means of room ventilation). This characteristic pattern is associated with flatulence than with the presence of any waste material (urine or faeces) because there is no on-going generation of gas (as would be the case if waste material were exposed) and the "smell" disappears rapidly. The second characteristic is a much slower shift in the average baseline level of gas detected as illustrated in Figure 7 of the accompanying drawings. This type of characteristic pattern indicates a more lingering presence of gas which suggests that the gas is not being dissipated by room ventilation, indicating that there is exposed waste material as a result of an incontinence event and this waste material is emitting ammonia (NH₃) gas continually so that, despite the room ventilation, the baseline level of the ammonia gas is increased.

Typically, any 24 hour recording of ammonia (NH₃) level in the room of an incontinent patient will include a mixture of both of these characteristic patterns. The system of the present invention is configured to distinguish between the two characteristic patterns in order to make an accurate detection of true incontinence and not merely flatulence.

A rapid downward trend of the second characteristic can be associated with two possible events:

a) Increased room ventilation, by opening a door or window that had previously been closed or by turning on an air conditioning fan that had previously been off; and b) Removal of the waste material by care staff. The first of these events can introduce an element of confusion as it might appear to indicate that the source of NH₃ gas has been removed when in fact all that has happened is that more aggressive ventilation is resulting in a more rapid dilution of the gas so that a lower concentration of gas is detected. Humidity and temperature may be used as control variables in this case. Increased ventilation will affect both these variables, i.e. humidity and temperature, irrespective of the concentration of NH₃ so that a reduction in level may be correctly attributed and compensated for.

The second of these events may be associated also with a transient spike in gas (similar to flatulence) as the patient is cleaned by the care staff and the waste material is temporarily more exposed. However, this can, in any case, be more definitively identified by the action of the care worker to press a "reset" button on the detection device to indicate that the patient is being looked after and the event that gave rise to an alert from the system has been resolved. The algorithm for detection of an incontinence event is fundamentally about detection of an increase in baseline level of ammonia (NH₃) taking account of those external factors such as ventilation and humidity. Because each room environment will be different, and the individual levels of ventilation will be different, the resulting rate of NH₃ dilution will be different from room to room. Therefore, the detection algorithm is configured to be adaptive so that it can take account of circumstances and "learn" the most appropriate threshold levels to apply. The inputs to this adaptive algorithm are: the gas concentration, room humidity and temperature, and care worker feedback. The adaptive process must start initially with a high level of sensitivity which is therefore likely to result in a high number of false positive alerts. This approach is essential for "training" the adaptive algorithm because it ensures the closest synchronicity between data thresholds and care staff feedback. As staff feedback either confirms or rejects the occurrence of incontinence, the adaptive algorithm forms correlations between gas concentration, rate of change of gas concentration, room ambience and incontinence events.

Optional features of the system of the present invention:

Environmental Conditions - The system of the present invention comprises low powered thermal and humidity sensors thereby allowing care staff to monitor and ensure their dependents are always in a pleasant optimal environment. With the system of the present invention, patients will be able to control both parameters, namely, heat as measured by the temperature and humidity. If the temperature and/or humidity levels become too high or too low a notification is sent to care staff, for instance to their hand held device.

Trip or Fall detection - Through the use of a two-way axial accelerometer, the device of the present invention, when worn or clipped to a resident can in an alternative embodiment including sensing means to detect if the resident has fallen over and is unable to get up. The system of the present invention detects a sharp rise in geometric force combined with limited movement indicating to the system controller to send a notification warning of a possible fall to the receiving device which provides the care staff with an alert either visual or aural.

Managerial Application - Informatics - The system comprises a task management application. This system allows users to electronically and remotely gather, manipulate, store, retrieve, and classify recorded information. This importantly enables the computerisation of care documentation within residential and skilled nursing homes. Care records can be easily accessed through IOS or a web browser by applicable staff and printed or viewed for review or updating. Advantageously for care providers, the system of the present invention enables instant point of care recordings that will save on time and minimise errors, these records are updated instantly and stored. In the event that the recording is considered serious an alert is constructed and remains until appropriate actions have been taken. Staff rotas and resident care plans can also and intuitively be created using the application of the present invention. For example, if a manger desires to make a change to staff duties, he/she can do so from any location even remote from the controller and this information will then be immediately presented to all care staff via their respective smart phones. Likewise, managers can easily create care plans surrounding new resident thereby ensuring that a very proficient though yet personal care provision is always provided.

Infrastructure & Methodology

The system of the present invention comprises a detection device which includes a casing/housing for housing the sensor, mini fan and the micro controller associated with the sensor. The detection device can be wall or rail mountable and is capable of free standing on a patient/resident locker. Membrane overlay is fixed to front face of the device to maintain a wipeable surface with printed indications for use. Membrane overlay will be of sufficient weight that it maintains a smooth appearance whatever the state of the underlying plastic material from which the housing is made. The system of the present invention incorporates a rechargeable Li-ion battery pack with sufficient capacity to permit normal product operation following full charge for up to 8 hours. The product can be powered and charged from an external DC power supply. The inlet for this DC power is by a DC connector but can potentially be provided by a USB connector.

To enable communication between devices and continual sever uploading and logging, the product incorporates a wireless stack, preferably a wireless proprietary 433 MHz stack, with a secondary built in Bluetooth stack to act as a failsafe. This allows the product to send data by a wireless connection to the connected web-based central server or directly to a user's hand-held device. The product uses a USB connector and internal USB electronics to facilitate a USB data connection between the product and a computer with suitable application software. Advantageously, the means by which the device detects episodes of incontinence relies not only on specific detection or thresholds break-though and more so on the monitoring of key gaseous diffusion trends.

The present invention also provides a system comprising the means to provide the user with the necessary informatics by means of its user-friendly task management web-based system.

Preferably, the sensors comprise sensors suitable for detecting relatively low levels of ammonia i.e. within the parts per million (ppm) and parts per billion (ppb) ranges. In accordance with the present invention, the levels of ammonia can be determined and related to an incontinence event, be it soiling or urination; as well as differentiating between flatulence; and differentiating between heavy to medium to light soiling. The apparatus and system of the present invention are selective and hence "false positives" are minimised and ideally, avoided.

Ideally, the system of the present invention comprises the following elements:

• at least one gas sensor,

• Integrated Circuit System with Microcontroller,

• Integrated Telemetry System,

· Electronic Casing & Packaging,

• Back-end software, and optionally

• web browser access.

The sensing device included in the present invention includes a sensor, also referred to as ambient gas sensing or "sniffer" device, for detecting ammonia which is ideally located close to the anatomical mid section of the incontinent sufferer. The option is available for the device to be external from the patient, i.e. on a bed locker, and/or even integrated into a wheelchair or similar hardware. The present invention also provides an enclosure casing for housing the integrated electronics and sensor device. The enclosure casing is specially adapted to house the electronics and sensor system of the present invention. The enclosure casing is particularly adapted to maximise airflow intake while reducing internal pressure inside the enclosure housing so as to ensure that the sensors function optimally. The design, packaging, and user interface of the detection device comprising the sensor for detecting a gas in accordance with the present invention fits comfortably into the nursing home culture and environment.

Incontinence by soiling: Human faeces and associated odiferous compounds

The distinctive odour of human faeces can be influenced by a range of chemical reactions but is dominated by a set of bacterial actions. The gut flora produces compounds and gases such as indole, skatole, and thiols (sulfur-containing compounds), as well as the inorganic gas such as hydrogen sulphide and ammonia.

Throughout the inventor's research phase, positive correlation was detected using sensors for detecting C0₂ and H₂S against diffused gases associated with urine and feaces; namely these sensors including the Figaro 4161 sensor for detection of Carbon Dioxide (C0₂) and Figaro TGS825 sensor for detecting Hydrogen Sulfide (H₂S). It became clear however that ammonia was the most reliable gas marker for use in association with the non-invasive detection of incontinence in accordance with the present invention. The Figaro TGS 826 sensor and more so, the Figaro TGS 2444 sensor for detection of ammonia were the most reliable sensors for use in the system of the present invention, and the Figaro TGS 2444 sensor is the most preferred sensor for use in the system of the present invention.

It is an advantage of the present invention that the present system for remote monitoring of incontinence includes a sensor that can distinguish between soiling and flatulence. Hence, false positives are reduced relative to prior art methods for detecting incontinence.

It should be noted that the system of the present invention comprises high selectivity sensors so as to ensure that the system has a low alarm rate, thus not showing false positive for artifacts such as room gases such are those found in cleaning product and/or flatulence. The system of the present invention also achieves this by including and using smart and intelligent processing algorithms that are trained on gold standard references and along with truth tables and calibration data, allow accurate thresholds to be identified.

The system and method of the present invention have the advantage that they provide the levels of sensitivity and specificity required to minimize or reduce false positives, i.e. false alarms of soiling due to mistaking a flatulence event for a soiling event.

The system of the present invention provides, in one system and with the sensing device housed within a single device, means for detecting incontinence by wetting (urination) and/or by faecal discharge. The system preferably, comprises the following elements:

• A Gas Sensor,

• Integrated Circuit System with Microcontroller,

• Integrated Telemetry System,

• Integrated RF system with optimised Aerial configuration,

· Backend software, and optionally

• mobile access.

The device and system of the present invention has the advantage that the wetting, soiling and flatulence detection and monitoring are incorporated into one unit.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

The present invention will now be described more particularly, by way of example only, with reference to the accompanying drawings. In the drawings:

Figure 1 is a schematic overview of the features of the system for detecting and monitoring incontinence in accordance with the present invention (elements such as the wireless wand do not comprise part of the present invention and are included in the schematic Figure 1 for descriptive purposes only);

Figure 2(a) is a plan view from above of one embodiment of the housing enclosure body of the detection device; the housing enclosure body including a specifically adapted air inflow and air flush system designed to quickly and optimally draw in ambient air into the housing of the device so that the ambient air is in contact with the sensor; and then quickly flush away the ambient air from the sensor, out of the enclosure housing once gas detection readings have been made by the sensor;

Figure 2(b) is a perspective view of the housing enclosure body of Figure 2(a);

Figure 2(c) is a front view of the housing enclosure body of Figures 2(a) and (b);

Figure 2(d) is a side view of the housing enclosure body of Figures 2(a), (b) and (c); Figure 3(a) is a plan view from above of the housing enclosure cap;

Figure 3(b) is a perspective view of the housing enclosure cap for the system of the present invention; Figure 3(c) is a front view of the housing enclosure cap of Figures 3(a) and (b);

Figure 3(d) is a side view of the housing enclosure cap of Figures 3(a), (b) and (c);

Figure 4 is a perspective view of the detection device shown closed, and shown with another embodiment shape of housing but also including a specifically adapted air inflow and air flush system designed to quickly and optimally draw in ambient air into the housing of the device so that the ambient air is in contact with the sensor; and then quickly flush away the ambient air from the sensor, out of the enclosure housing once gas detection readings have been made by the sensor;

Figure 5 is a perspective view of the detection device as shown in Figure 4 but with the device now shown opened with parts separated for descriptive purposes; and including a specifically adapted air inflow and air flush system designed to quickly and optimally draw in ambient air into the housing of the device so that the ambient air is in contact with the sensor; and then quickly flush away the ambient air from the sensor, out of the enclosure housing once gas detection readings have been made by the sensor;

Figure 6 shows a typical graphical spike showing the ammonia pattern associated with a flatulence event; Figure 6 shows a sharp spike characteristic with an exponential decay. Clearly this represents a rapid increase in the local concentration of NH3 followed by the dissipation of the gas (probably by means of room ventilation). This characteristic is most likely associated more with flatulence than with any incontinent material (urine or faeces) because there is no on-going generation of gas (as would be the case if waste material were exposed) and the "smell" disappears rapidly;

Figure 7 is a chart representing in is a much slower shift in the average baseline level of gas detected. This type of characteristic indicates a more lingering presence of gas which suggests that it is not being dissipated by room ventilation because there is exposed waste material arising from incontinence that is excreting NH₃ gas continually so that despite the room ventilation the baseline level of gas is increased;

Figure 8 is a flowchart showing the steps to be taken by an algorithm which discriminates between a soiling event and a flatulence event; Figure 9 is a graphical representation showing two episodes of incontinence and the associated ammonia levels and pattern associated with these episodes; and

Figure 10 is plan view of the pre-assembled PCB casing. The components of the system and method of the present invention will now be described more particularly, by way of example only, with reference to the embodiments shown in the drawings.

Design of the detection device and housing for the detection device

Referring to Figures 4 and 5 of the diagrams, the detection device includes the following features which are indicated by the following reference numerals:

Detection device including housing for housing the sensor, fan and micro-controller, the detection device is indicated generally by reference numeral, 100;

Housing cover 101 ; (alternative embodiment of housing cover 101 ')

Housing base 102; (alternative embodiment of housing base 102')

Fan 105

Vents 170

Vents 180

Control buttons/re-set buttons 1 10

Battery 120 PCB 150

Sensor 140

Support frame 160 for fan 105

Upright 190.

The detection device 100 comprises: A bidirectional fan 105 included in the device 100 that the fan 105 that is programmed to flow at a rate of 3+ l/min. The flow rate of the fan 105 is set to ensure maximum suction but acceptable flow over gas sensor 140. The design of enclosure cover 101 and housing base 102 will have considerable impact on sensing gas and as such care will be taken to design vents 170, 180 and filtering with specifically placed fan(s) 105.

Detailed description of the incontinence detecting system of the present invention

Referring to Figure 1 , a typical arrangement is schematically shown, whereby the gas sensor, with microprocessor/telemetry unit, broadcasts to a detector and then to a nursing console for monitoring the alarms provided when an incontinence event is detected.

Referring to the diagrams, the operation of the system for detecting incontinence, in accordance with the present invention will now be described.

As shown in Figure 1 , the system of the present invention includes an ammonia sensor. A sensor for detecting ammonia gases is preferred so that one sensor can detect incontinence by soiling or wetting. A controller controls the sensor. The sensor is "on" continuously.

Referring now to Figure 8, the steps in the algorithm will be described. Detection of Ammonia: No

During a sensor scan, i.e. sensor warm ups, the fan pulls in ambient air for 15 seconds and sensor "sniffs'Vdetects. If ammonia is not detected, then the sensor is powered down into power save mode under the control of the onboard microprocessor.

Detection of Ammonia: Yes

If ammonia is detected, the concentrations and trend of the detected ammonia is analysed via the decision making code programmed into the onboard microcontroller. Gas detected: Ammonia

If ammonia gas is detected, then if the concentration and trend of this gas falls outside the set parameters programmed to signal an incontinent event, the event giving rise to this level of ammonia is determined by the system to have been a flatulence or irrelevant event and therefore no alarm is triggered as it is of course, not necessary to alert a carer (Referring to Figure 8, an alarm/alert is indicated by reference letter "A").

On the other hand, if the level of ammonia is above the predetermined value and resides within the set incontinent parameters, then the telemetry unit is powered up and an alarm signal can be sent, e.g. by 433 MHz wireless transmission or by bluetooth technology so that an alarm is triggered to start on a monitoring interface which may be a monitoring station or a hand held monitoring unit. The alarm signal can be pre-set using the algorithm to be emitted to a pre-determined number of times per minute e.g. twice per minute and may include a message such as "wetting - patient in room 1 1 needs attention".

If ammonia gas is detected, then if the concentration is below a predetermined value of ammonia, the event giving rise to this level of ammonia is determined by the system to have been a flatulence event and therefore no alarm is triggered as it is of course, not necessary to alert a carer.

The alarm signal will be intermittently emitted until the alarm has been reset. Once the alarm signal has been reset on the monitoring interface i.e. the detection device 100, the alarm is powered down into dormant mode.

Referring to Figure 9, there is shown a graph which demonstrates the ammonia levels detected associated with two episodes of incontinence. As can be seen from Figure 9, there is a range of ammonia levels detected over a period of time following an incontinence event, over a range of approx 150 ppm to 350 ppm; more particularly, between the range 150 to 300 ppm. In general from Figure 9, the ammonia level detected is approximately measured as an increase of around 200 ppm over the baseline.

It should be noted that further embodiments of the system may comprise: means acting as an early warning sign for ailments that are increased by incontinence, e.g. urinary tract infection. In this embodiment, the system, through biochemical sensing, would detect compounds and metabolites associated with such diseases. More so then just checking absolute peak values the decision making protocol of the system according to the invention preferably analyses the following:

First order derivative in relation to sensor output; which is scanning for ambient ammonia levels (essentially monitoring for a increase in output over time). A steady linear climb in output signifies an incontinent event. A sharp climb in output, followed by a quick drop would indicate flatulence or a passing smell not associated with a bowel or bladder movement.

Preferably, electronic filtering techniques are employed to aid with linearity of sensor output. This essentially enables the sensor output to be responsive yet not hyperactive. Advantageously, the decision making protocol of the system can be tuned, in relation to deciding when to sanction 'incontinence has been detected'. This involves setting time thresholds in relation to analysing the first order of derivative. The shorter the amount of time allowed to pass during a linear climb before sanctioning the detection of incontinence equates to a high sensitivity setting. This might be favourable for individuals with irritable skin, and care staff want to ensure they are alerted at the presence of even the smallest amounts of urine. The greater the amount of time allowed to pass during a linear climb before sanctioning the detection of incontinence equates to a low sensitivity setting.

Example 1

Sensors for detecting gases associated with incontinence events were tested and the following parameters were taken into account:

Marker, i.e. faeces and/or urine

- Temperature

Humidity

Distance

- Geometry

Environmental Conditions, e.g. ventilation due to open window

Air flows and

Dietary intake of the patient sample provider All testing occurred on a continual basis. The Figaro TGS 2444 sensor for detecting ammonia was used. The TGS 2444 showed positive and repeatable results for the detection of both urine and faeces at a distance of over 1.5 m. This is a reliable sensor and showed excellent reliability when tested in the system of the present invention with the detecting device comprising the housing enclosing the sensor; positioned at the end of a nursing home resident's bed. Main PCB This PCB has the IC chip, the Accelerometer IC and the Radio IC.

Sensor The sensor detects if the marker gas is present. In the preferred embodiment, the sensor is a sensor for detecting ammonia.

Bluetooth PCB This is the PCB board which connects the Bluetooth module, temperature and humidity, to the Main PCB. The Bluetooth may be used to communicate that an incident as happened.

Base Station The base station is used to recharge the battery. It is connected to an

AC/DC Adapter when needed.

Battery 7.4V Li-Polymer rechargeable battery.

USB currently used for Technical Debugging (setting thresholds, taking readings, etc.) Fan This is included in the housing of the unit. It pulls air across the sensor and expels it away from the unit.

User Interface The current user interface has 4 buttons, and two LEDs: Button 1 switches on the unit. Button 2 clears the alerts. Button 3 switches the unit off. Button 4 creates a user alert. Yellow LED - Indicates a Bluetooth connection. Red Flashing LED - Indicates that the unit is on and sampling the air.

Features of the present system are indicated as follows:

Detection Device

The detection device includes a sensor for monitoring the temperature of the air that is being tested. This temperature will serve as both a sample of the ambient temperature in which the patient is found and at the same time a normalising variable for the gas sensors in the product. An example of a suitable temperature sensor is the Sensirion™ SHT1 X. The Applicant proposes that the recorded temperature by the sensor module should not differ from independent measure of room temperature by more than +/- 0.5 °C. This feature should come with the option for the user to set thresholds & be alarmed if these thresholds are breached.

Humidity measurement sensor

The detection device includes a sensor for monitoring the humidity of the air that is being tested for the same reasons as indicated above. The recorded humidity should not differ from independent humidity measurement by more than +1-5%. This feature includes the option for the user to set thresholds and emit an alarm if these thresholds are breached. An example of a suitable sensor is the Sensirion™ SHT1 X. Call button In a preferred embodiment, the system includes an external stand alone wireless call alert e.g. a "nurse call button" as an additional but important feature. This nurse call button will be external to the detection device and will have the ability to wirelessly communicate to the web or hand held device. The feature will comply with existing standards for the specification of nurse call buttons.

Microphone The system comprises a microphone to allow a carer to hear resident on command. The microphone has an approx three metre proximity detection range.

Speaker The detection device comprises a speaker to allow the resident to hear the carer. As for the microphone, the speaker has an approximate range of three metres.

Intelligent firmware The system is controlled by a microprocessor running internal firmware that is programmed with an algorithm for interpreting the raw data input and making operational decisions about what messages to provide to care staff in response.

Wireless data connection system The system incorporates a radio communications feature which will include either a WiFi stack or a Bluetooth stack so that the product can send data by a wireless connection to a mobile phone handset or other computing device. 433 MHz wireless communication will act as the main communication means to enable communication to the web application. With Bluetooth as a failsafe, which will be engaged and transmit alerts to paired hand held devices in the event that the 433 wireless transmission fails. Example: Matchport 900486 and LMX98 38S.

USB data connector Similar to A6 the product should provide a USB connector and internal USB electronics to facilitate a USB data connection between the product and a computer with a suitable application software. The module should be able to exchange data via a laptop USB port. An example of a USB data connection is the FTDI FT232R.

Real time clock The product should incorporate a real-time clock with independent operation such that it can maintain the current time even when the power to the device is switched off (subject to at least minimal battery life). The module should maintain time with better than 200ppm accuracy. Integral to processor STM32F103xC.

Internal rechargeable battery The product should battery pack with sufficient capacity to permit normal product operation following full charge for up to 6-8 hours. The battery solution should be as dense as possible and ideally a flat pack solution; to facilitate with bespoke enclosure build. An example is microchip MCP73213.

Non-volatile memory The product should incorporate non-volatile memory to hold user settings and logged results indefinitely without reference to power status. Verify by retrieving data from memory via USB port even after a full power cycle (by disconnecting the battery). An example is the Atmel AT45DB642D.

On/Off switch The device can be switched on and off with a simple switch.

Reset button The device is resettable - the definition of a reset event may be further clarified but should at least permit a carer to inform the device that care has been given and thus reset its baseline to inhibit it from any further alerts until a new waste smell has been recognised. Pin/prong accessible, e.g. a reset button. KMR series micro-tact switch.

Fan to achieve bi-directional airflow across sensors The product should maintain a flow of air over the integrated sensors. This flow rate and direction should be controllable by an integrated fan (or fans). It is desired that the fan be bi-directional to enable minimal openings in external enclosure. It is also envisaged that this type of suck in and blow out mechanism would increased reliability of sensing Fan flow rate should be controllable from 1 Lpm to at least 61 pm. An example is the SEPA MF15A05.

Camera The device may include a camera capable of live feed & still images, and also allow for night time monitoring. It should be an additional bolt on unit. The camera unit rather than being attached to the monitoring device itself, includes the ability to connect to the central charging hub; the charging hub will be main powered. A 3-5MP camera should be used with night vision capabilities and the ability to take still pictures and Live video feed. Cameras which are suitable for inclusion in the system of the present invention:

1 . Truly® Camera Module - CM8206-A 500SA-E

2. ST 2 Megapixel single-chip camera module VS6724

The casing surrounding the camera lens has LED lights incorporated.

Minimum two/axial docking/charging hub to allow for 360 rotation and suitable tilt function although this can be incorporated into the design of the charging HUB; and with remote panning. VS6724 or CM8206-A500SA. LED indicators The product should provide a status indication to the user by means of LED indicators of various colours and labelled appropriately. The purpose and colour and labeling for these indicators remains to be defined.

DC power Jack The product should be powered and charged from an external DC power supply. The inlet for this DC power should be by a DC connector but could potentially be provided by the USB connector - to be confirmed subject to power considerations. It is desired that this power jack have a magnetic connection mechanisms.

Accelerometer The sensing device can act as fall indicator by including an accelerometer sensor. As such a 2/3way axial accelerometer should be built in. Freescale MMA7660FC

Charging & Docking HUB The system comes with a central docking station that will double in functions to: 1 ) Act as receptacle hub for the a) call button b) the camera c) the sensing device and 2) charge the devices while they are docked.

Telemetry and Back-end Software It has been shown that there is no difficulty using a set of channels to transmit data over a 100m range (even within a walled home) to a back- end system that would detect and alarm based on key system configurations. Location software can also be included in the system to give the position of a person to within 1 m within a standard building.

It should be understood that certain aspects of the present invention has been described, by way of example and it should be appreciated by the reader that augmentations and/or modifications may be made thereto without departing from the scope thereof.

Claims

Claims:

1 . A system for detecting and monitoring incontinence in a mammal, the system comprising:

(d) means for detecting a gas associated with incontinence;

(e) means for transmitting the detected gas level to a central controller;

(f) means for comparison of the detected gas level with a pre-determined reference parameter;

(g) means for transmitting a signal to a receiving device if the detected gas level is equal to or exceeds the reference parameter.

2. The system as claimed in claim 1 , further comprising means of analytically distinguishing between soiling and flatulence based on at least one reference parameter, the at least one reference parameter comprising a gas level and/or predetermined specified gas behaviour.

3. The system as claimed in claim 1 or claim 2, further comprising means for displaying data associated with the transmitted signal data on display means of the system.

4. The system as claimed in any one of claims 1 to 3, wherein the means for detecting a gas associated with incontinence comprises a sensing device capable of sensing the presence of ammonia.

5. The system as claimed in any one of the preceding claims, wherein the system is configured to distinguish between the emissions profile associated with a flatulence event and the emissions profile associated with a soiling event in order to make an accurate detection of incontinence and not merely flatulence.

6. The system as claimed in any one of the preceding claims, further comprising means for enabling data to be automatically received or downloaded to the controller from a computer and/or via a network connection.

7. The system as claimed in any one of the preceding claims, wherein the receiving device comprises a portable device such as a portable hand-held device with an internet or web-browser connection.

8. A system as claimed in any one of the preceding claims, wherein the mammal is a human.

9. The system as claimed in any one of the preceding claims comprising sensor housing specifically adapted for facilitating the operation of the sensing device.

10. The system as claimed in claim 9, wherein the sensor housing is configured to include vents through which air flow can enter into the sensor housing and preferably also includes a means for drawing air close to the region of the sensing device to maximise opportunity for the sensing device to detect the relevant gas, particularly preferably wherein the means for drawing in air into the housing comprises a fan.

1 1 . The system as claimed in any one of the preceding claims, further comprising means for monitoring residents' environments and detecting a range of conditions which impact on the residents' safety and well being.

12. A system for detecting and monitoring incontinence in a mammal substantially as herein described with reference to and as shown in the accompanying drawings.

13. Use of analytical spectroscopy to analyse and profile the output of gases associated with human incontinence and flatulence.

14. Use of gas sensors in the system as claimed in any one of claims 1 to 12.

15. Use of a gas sensing device combined with wireless transmission capability and backend software to present to the user/carer that there has been an episode of incontinence.

16. Use of a gas sensor for specifically detecting levels of a diffused gas arising from a flatulence event or an incontinence event; combined with an algorithm, the algorithm being configured to compare the detected level of diffused gas with a predetermined parameter associated with diffused gas from an incontinence event; means to transmit a signal if an increase above a baseline level of gas is detected, the signal being transmitted by wireless transmission.

17. A method of detecting and monitoring incontinence in a mammal, the method comprising the following steps:

(d) detecting a gas associated with incontinence;

(e) transmitting a signal indicating the detected gas parameter to a central controller;

(f) comparing the detected gas parameter with a pre-determined reference parameter; and

(g) transmitting a signal to a receiving device if the detected gas parameter is equal to or exceeds the reference parameter.

18. The method of detecting and monitoring incontinence in a mammal as claimed in claim 17, wherein the method relies not only on specific detection or thresholds break- though and more so on the monitoring of learned gaseous diffusion trends.

19. The method of detecting incontinence in a mammal as claimed in claim 17 or claim 18, wherein the method includes the step of monitoring diffusion of said gas associated with incontinence.

20. The method of detecting incontinence in a mammal as claimed in any one of claims 17 to 19, wherein the method includes the step of monitoring the first order derivative of said gas associated with incontinence.

21 . The method of detecting incontinence in a mammal as claimed in any one of claims 17 to 20, wherein the method includes the step of monitoring for prolonged linear increase of said gas associated with incontinence over set times.

22. The method of detecting incontinence in a mammal as claimed in any one of claims 17 to 21 , wherein the method includes the step of monitoring for prolonged linear increases and decreases of said gas associated with incontinence over set times to determine and distinguish between a soiling event and a flatulence event.

23. The method of detecting incontinence in a mammal as claimed in any one of claims 17 to 22, wherein the method includes the step of utilising an electronic filter to reduce irrelevant sensor output.

24. The method as claimed in any one of claims 17 to 23, further comprising the step of sending a notification to a carer when the detected gas level is equal to or exceeds the reference level.

25. A method of detecting and monitoring incontinence in a mammal substantially as herein described with reference to and as shown in the accompanying drawings.