WO2016174465A1

WO2016174465A1 - Patient monitoring

Info

Publication number: WO2016174465A1
Application number: PCT/GB2016/051241
Authority: WO
Inventors: Menachem Mendel Sudak
Original assignee: Menachem Mendel Sudak
Priority date: 2015-04-30
Filing date: 2016-04-29
Publication date: 2016-11-03
Also published as: GB201507391D0

Abstract

A monitoring system (1) for monitoring a patient, the system (1) comprises a detection pad (2) and a control unit (4), the pad (2) comprising a planar member with two or more zones or regions (Z1, Z2, Z3...Zn) each of which comprises a sensor (3) for measuring a parameter, e.g. the same parameter, associated with the state of a patient, wherein the control unit (4) is configured to record, in use, over a predetermined period of time two or more measurements of said parameter measured by each sensor (3) and to analyse the four or more measurements and/or compare them to a database in order to determine a state of the patient.

Description

PATIENT MONITORING

This invention relates generally to patient monitoring and more specifically to systems, devices and methods for monitoring patients. More specifically, although not exclusively, this invention relates to monitoring systems provided on, under or incorporated into mattresses.

It is known to provide a pressure pad beneath a mattress that is configured to monitor a newborn child to detect long periods of non-breathing and to alert the parents. Such monitoring devices are generally configured to detect changes in weight distribution across the pad that are caused by breathing, thereby to identify instances where breathing ceases. These monitoring devices are generally used by parents hoping to mitigate the risk of cot death. However, and despite their widespread use, there is no research evidence that such devices do, in fact, prevent cot death.

It is also known to provide monitoring systems incorporating bioinstrumentation on the underside of the mattress for monitoring of vulnerable individuals. This bioinstrumentation is configured to detect an eccentric state or event, such as irregular respiration and/or a fall out of bed. As with the pressure pad for newborn children, the purpose of these systems is to alert an authority of the eccentric state or event for them to take appropriate action.

There is a constant drive to improve efficiency and reduce cost in healthcare, particularly in countries that provide state funded healthcare. Any system that enables such improvement and/or cost savings is therefore desirable.

It is a first non-exclusive object of the invention to provide a monitoring system and method that is an improvement over known systems and that reduces the need for constant monitoring of vulnerable individuals. It is further non-exclusive object of the invention to provide a monitoring system and method that provides earlier detection of abnormal activity in a patient.

Accordingly, a first aspect of the invention provides a monitoring system for monitoring a patient, the system comprising a detection pad and a control unit, the pad comprising a planar member with two or more zones or regions each of which comprises a sensor for measuring a parameter, e.g. the same parameter, associated with the state of a patient, wherein the control unit is configured to record, in use, over a predetermined period of time two or more measurements of said parameter measured by each sensor and to analyse the four or more measurements and/or compare them to a database in order to determine a state of the patient.

The provision of a detection pad having multiple regions each with a sensor that detects the same parameter enables a more comprehensive analysis of the state of the patient to be carried out. This is achieved by monitoring the parameters measured by each sensor over time, thereby providing data incorporating both position and time based variation. The invention therefore enables trends to be determined from the captured data, providing both insight into the state of the patient and the ability to predict the onset of one or more conditions, for example after a surgical or therapeutic event.

For the avoidance of doubt, the term "measure" should be interpreted broadly to encompass the detection of a parameter, for example in the form of a binary measurement. In addition, the term "patient" as used herein refers to any individual, whether in hospital or a care facility or in their home.

Another aspect of the invention provides a detection pad, e.g. for use in a system as described above, the pad comprising a planar member with two or more zones or regions each of which comprises a sensor for measuring a parameter, e.g. the same parameter, associated with the state of a patient.

Preferably, the pad comprises a plurality of regions or zones, referred to hereinafter as "zones" but this term may be replaced with "regions". Two or more, for example three or more (for example 4, 5, 6, 7, 8, 9, 10 or more zones), preferably a plurality of zones, e.g. all zones, may comprise a respective sensor, e.g. for detecting or configured to detect the parameter. In some embodiments, less than all, for example most, but possibly half or less of the zones may comprise a respective sensor. At least one or each sensor may be mounted in a predetermined position within each zone, for example at the centre of the zone, which may comprise a sensor node.

In embodiments, the pad comprises two or more different sensor types. In some embodiments, each of the different sensor types are comprised or located in a respective different zone, but preferably at least one zone comprises two or more different sensor types. The pad may comprise two or more first sensors and or two or more or a plurality of second sensors, for example wherein the first sensors are for measuring or configured to measure a first parameter and/or the second sensors are for measuring or configured to measure a second parameter. The pad may further comprise one or two or more or a plurality of third and/or fourth and/or further sensors, which may each be for measuring or configured to measure a third, fourth or further respective parameter. The sensors may be grouped or clustered, for example wherein two or more zones may each comprise at least two different sensors. Preferably, the pad comprises a plurality of zones at least one or each comprising at least two different sensors.

The first, second, third, fourth or further parameters may comprise any one of motion or pressure or weight, e.g. wherein the sensor may comprise a pressure sensor or strain gauge or other motion sensing device; humidity, e.g. wherein the sensor may comprise a humidity sensor; moisture, e.g. wherein the sensor may comprise a moisture sensor; temperature, e.g. wherein the sensor may comprise a temperature sensor or thermocouple; and/or one or more chemical characteristics, wherein the sensor may comprise a chemical sensor. One or more of the sensors may comprise a capacitive and/or resistive and/or conductive means or mechanisms. In some embodiments, the sensor may comprise a combined sensor able to measure two or more parameters.

The control unit may be configured to receive or retrieve data, e.g. measurement data, from one or more or each sensor or all of the sensors, for example at predetermined time intervals, e.g. where the sensor or sensors are passive sensors. Additionally or alternatively, one or more or each sensor or all of the sensors may be configured to send or transmit data, e.g. measurement data, to the control unit, for example at predetermined time intervals, e.g. where the sensor or sensors are active sensors. The predetermined time intervals may be selected based on the application in question. In some embodiments, the data may be received or retrieved or sent or transmitted on detection of a predetermined condition, rather than at predetermined time intervals. For example, the predetermined condition may comprise a change in the parameter measured, e.g. an increase or decrease in temperature or pressure measured by one of the sensors. On detection of the predetermined condition, data measured by one or, alternatively, two or more sensors, e.g. one or more groups or even all of the sensors, may be received or retrieved or sent or transmitted. The control unit may be configured to associate data received or retrieved, in use, with the zone or node from which the data was measured and/or with a time of receipt or retrieval. In some embodiments, the control unit includes a memory means that may be partitioned to provide separate and/or distinct memory sections or segments associated with each zone. In embodiments, the data is tagged prior to or during transmission from the sensor or on or after receipt or retrieval by the control unit. The data tag may comprise data relating to the zone or node from which the data was measured. The data tag may be stored together with the data in or on the memory means.

The sensors may be operatively connected to one another, for example via a network, e.g. a network of cables or leads, and/or all sensors may be connected to the control unit by a single connection. Alternatively, each sensor may be operatively connected to the control unit individually and/or separately, either by a cable or lead or wirelessly or via any other suitable means.

It will be appreciated by those skilled in the art that the grouping or clustering of different sensors may be selected based on the application. For example, it may be beneficial to include both pressure and temperature sensors in one or more particular zones, whilst one of the sensors may be omitted from other zones or replaced with a different type of sensor. In some embodiments, each zone includes one of at least two different sensors, for example at least three or four different sensors, e.g. wherein one or more of the sensors may be disablable. This may be beneficial to reduce manufacturing costs, wherein any particular application may simply disable any sensors that are not required.

The pad may also comprise one or more therapeutic delivery means. Preferably a therapeutic delivery means may be associated with each region. In a preferred embodiment the, some or each of the therapeutic delivery means may be operable in response to an activation signal. The activation signal may be generated in response to, or in consequence of, a signal received from one of the sensors. For example, if the sensor detects a certain state, as interpreted by the control unit, an activation signal may be generated to cause to be delivered a therapeutic agent to the patient. The therapeutic agent may be a medicament, heat, cold, vibration, electrical stimulation and so on. For example the therapeutic delivery means may comprise a Transcutaneous Electrical Nerve Stimulation (TENS) device arranged to deliver TENS to the associated area of a patient. The therapeutic delivery means may be operable to cause or encourage a patient to move or to otherwise stimulate the patient, for example to increase local blood flow.

The pad may comprises a sheet, which may comprise one or more layers. The two or more sensors may be mounted or located on or in the sheet, e.g. a layer of the sheet. In some embodiments, the sheet comprises two layers and the sensors are mounted or located between the two layers. At least one or each layer may comprise a fibre material, for example a woven fibre material that may comprise synthetic and/or natural fibres. In embodiments, the pad comprises a sheet for placing on or over a mattress, in which case it may comprise a mounting or securing means such as an elasticated periphery or edge, e.g. an elasticated peripheral edge. Such an embodiment is useful because existing mattresses can be used in combination with the detection pad. In embodiments, the pad is comprised in or incorporated in a mattress, for example in, on or under an upper surface or layer or ply of a mattress.

The pad may comprise a printed circuit board, which may be flexible and/or may comprise or incorporate or be operatively connected at least one or each sensor. The pad and/or at least one or each sensor may be operatively connected to the control unit, for example by a cable or lead or wirelessly, e.g. via a wireless link such as a wireless radio signal means or telecommunications link. The pad may comprise or be operatively connected to a transmitter for sending data, e.g. measurement data, measured by at least one or each of the sensors to the control unit, which itself may comprise a receiver, e.g. for receiving the data. In some embodiments, the control unit comprises a transceiver, for example wherein at least one of the sensors is passive, thereby to query one or more sensors for measuring the parameter.

The control unit may be configured to generate an alert or alert an authority, for example if the state of the patient is determined to correspond to a vulnerable state, e.g. if one or more thresholds are exceeded. The alert may comprise sending a control signal to monitoring station and/or by generating an audible and/or visual alarm means, such as a siren and/or visual or light based alarm. The system may comprise a display, which may comprise the visual alarm and/or may be operable to display a graphical representation of the data or one or more trends associated with the data. The control unit may be operable or configured to generate the graphical representation, which may comprise a graph representing the measured data or one or more calculated parameters derived from the measured data or a trend identified therefrom.

The one or more thresholds may comprise threshold value(s) associated with the measured parameters or their rate of change. Additionally or alternatively, one or more thresholds may comprise threshold value(s) associated with calculated parameters, which may be derived from one or more of the measured parameters. This approach may be particularly useful where the system is used to detect or anticipate a predetermined state that is determined based on a complex relationship between two or more parameters.

The control unit may be configured to determine or detect a trend in data received or retrieved, in use, from the sensors. The trend may be determined with reference to an algorithm or database that may include values and/or ranges for one or more, e.g. two or more, measured or calculated parameters or their rate of change over time, which values and/or ranges may be considered by the control unit or system to correspond to a predetermined state. In some embodiments, the predetermined state may comprise or be associated with a particular reaction, e.g. adverse reaction, associated with a surgical or therapeutic procedure or treatment or a pharmaceutical dosage or treatment regime.

Advantageously, if the monitoring system is deployed across plural beds and in respect of plural patients, each undertaking or receiving the same surgical or therapeutic procedure or treatment or a pharmaceutical dosage or treatment regime it will be possible to collate large amounts of time-defined data relating to the patient's response to the particular surgical or therapeutic procedure or treatment or a pharmaceutical dosage or treatment regime. For example, if two drugs are co-administered, it will be possible to monitor and measure the physical response the patient has, and how plural patients respond. By combining the physical response data with other patient-specific data, and deploying computer mining and/or analytic techniques ( for example 'big data' type analytics) it may be possible to extract important information concerning the response of particular patients to said co-administered drugs which would not otherwise have been available or capable of being determined.

The control unit preferably records and/or analyses the data to adapt or update, e.g. automatically, one or more thresholds. In some embodiments, the control unit is configured to compile a profile of the monitored patient. For example, the control unit may comprise an algorithm for identifying one or more trends in the data received or retrieved that are associated with the patient. The control unit may be configured to update, e.g. automatically, one or more thresholds based on the identified trends.

In some embodiments, the control unit is configured to compile and/or analyse data associated with two or more, for example a plurality of, patients. The control unit may be configured to store the data for later analysis. Additionally or alternatively, the control unit may be configured to determine or adapt one or more trends or thresholds associated with a particular state or condition, for example to generate or update a generic profile for the state or condition.

This generic profile may be used, for example, to assist with conventional diagnosis. In such cases, the control unit may be configured to create or generate or select a graphical display that may illustrate the generated or updated profile, for example to provide medical staff with a visual representation of the symptoms or trend in symptoms associated with the condition. The graphical representation may comprise a table and/or graph and/or textual matter.

Another aspect of the invention provides a method of monitoring a patient, the method comprising the steps of positioning a patient on a detection pad with two or more zones or regions each of which comprises a sensor for measuring a parameter, e.g. the same parameter, associated with the state of a patient, recording over a predetermined period of time two or more measurements of said parameter measured by each sensor and analysing the four or more measurements and/or compare them to a database in order to determine a state of the patient.

For the avoidance of doubt, any of the features described herein apply equally to any aspect of the invention. For example, the system may comprise any one or more features of the detection pad and vice versa and/or the method may comprise any one or more features or steps relevant to one or more features of the system or the detection pad.

Another aspect of the invention provides a computer program element comprising and/or describing and/or defining a three-dimensional design for use with a three-dimensional printing means or printer or additive manufacturing means or device, the three- dimensional design comprising an embodiment of the detection pad described above. A yet further aspect of the invention provides a method of reducing the likelihood of a person lying in a bed suffering an injury whilst lying in the bed, the method comprising providing on or in the mattress comprising part of the bed a detection pad having two or more zones or regions each of which comprises a sensor for measuring a parameter, e.g. the same parameter, associated with the state of the person lying in the bed and taking readings from each sensor to determine the parameter and, in accordance with the readings issue an alert to a care provider and/or automatically deliver a stimulus to the person using a therapeutic delivery means associated with the pad, or at least associated with a zone or region of the pad.

The therapeutic delivery means may be arranged to deliver, as a stimulus, a therapeutic agent to the patient. The therapeutic agent may be a medicament, heat, cold, vibration, electrical stimulation and so on. For example the therapeutic delivery means may comprise a Transcutaneous Electrical Nerve Stimulation (TENS) device arranged to deliver TENS to the associated area of a patient. The therapeutic delivery means may be operable to deliver a stimulus to cause or encourage a patient to move or to otherwise stimulate the patient, for example to increase local blood flow.

A further aspect of the invention provides a computer program element comprising computer readable program code means for causing a processor to execute a procedure to implement the aforementioned method. A yet further aspect of the invention provides the computer program element embodied on a computer readable medium.

A yet further aspect of the invention provides a computer readable medium having a program stored thereon, where the program is arranged to make a computer execute a procedure to implement the aforementioned method.

A yet further aspect of the invention provides a control means or control system or controller comprising the aforementioned computer program element or computer readable medium.

For purposes of this disclosure, and notwithstanding the above, it is to be understood that any controller(s), control units and/or control modules described herein may each comprise a control unit or computational device having one or more electronic processors. The controller may comprise a single control unit or electronic controller or alternatively different functions of the control of the system or apparatus may be embodied in, or hosted in, different control units or controllers or control modules. As used herein, the terms "control unit" and "controller" will be understood to include both a single control unit or controller and a plurality of control units or controllers collectively operating to provide the required control functionality. A set of instructions could be provided which, when executed, cause said controller(s) or control unit(s) or control module(s) to implement the control techniques described herein (including the method(s) described herein). The set of instructions may be embedded in one or more electronic processors, or alternatively, may be provided as software to be executed by one or more electronic processor(s). For example, a first controller may be implemented in software run on one or more electronic processors, and one or more other controllers may also be implemented in software run on or more electronic processors, optionally the same one or more processors as the first controller. It will be appreciated, however, that other arrangements are also useful, and therefore, the present invention is not intended to be limited to any particular arrangement. In any event, the set of instructions described herein may be embedded in a computer-readable storage medium (e.g., a non-transitory storage medium) that may comprise any mechanism for storing information in a form readable by a machine or electronic processors/computational device, including, without limitation: a magnetic storage medium (e.g., floppy diskette); optical storage medium (e.g., CD-ROM); magneto optical storage medium; read only memory (ROM); random access memory (RAM); erasable programmable memory (e.g., EPROM ad EEPROM); flash memory; or electrical or other types of medium for storing such information/instructions.

A further aspect of the invention provides a method of monitoring the effect of administering a medicament to a patient, and preferably to plural patients, the method comprising locating a patient on a detection pad, or plural patients on respective detection pads, which or each detection pad has or having two or more zones or regions each of which comprises a sensor for measuring a parameter, e.g. the same parameter, associated with the state of the person located on the pad and administering a medicament to said patient or patients located on the, or respective, pad or pads and taking readings from each sensor to determine the parameter to monitor the condition of the patient or patients in response to administration of the medicament. This method will enable the compilation of a data set in response to administration of a medicament. For example, the data set may be collation of temperature and/or movement data, for example over time. By monitoring plural patients after administration the data set will be usable to generate a profile of expected responses. This may be of particular benefit when plural medicaments are co-administered, either simultaneously or successively.

Within the scope of this application it is expressly intended that the various aspects, embodiments, examples and alternatives set out in the preceding paragraphs, in the claims and/or in the following description and drawings, and in particular the individual features thereof, may be taken independently or in any combination. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination, unless such features are incompatible. For the avoidance of doubt, the terms "may", "and/or", "e.g.", "for example" and any similar term as used herein should be interpreted as non-limiting such that any feature so-described need not be present. Indeed, any combination of optional features is expressly envisaged without departing from the scope of the invention, whether or not these are expressly claimed. The applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to amend any originally filed claim to depend from and/or incorporate any feature of any other claim although not originally claimed in that manner.

Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings in which:

Figure 1 is a schematic representation of a monitoring system according to an embodiment of the invention;

Figure 2 is a schematic representation of a section through the thickness of the detection pad of the system of Figure 1 ;

Figure 3 is a schematic representation of a monitoring system according to another embodiment of the invention; and

Figure 4 is an exploded view of a bed comprising a detection pad according to the invention.

Referring now to Figure 1 , there is shown a monitoring system 1 for monitoring a reposed individual or patient. The system 1 includes a detection pad 2 segregated into zones Z1 , Z2, Z3... each of which includes a respective sensor 3 which are operatively connected to a control unit 4 by an lead 5. The zones Z1 , Z2, Z3... of detection pad 2 are sized and shaped to be substantially the same and form a grid. It will be appreciated that the number and size of zones Z1 , Z2, Z3... shown in Figure 1 is for illustrative purposes only and it is envisaged that they may be greater in number than shown, with their size being smaller.

The detection pad 2 in this embodiment is formed of a woven fabric material, which may be composed of any suitable material, including manmade fibres (e.g. polyester, nylon, etc.) or natural fibres (e.g. cotton, wool, etc.), or a combination of both. The materials may be or may comprise non-woven materials such as spunbond, felted or other materials. As shown in Figure 2, the detection pad 2 includes an upper layer 6 and a lower layer 7, each of which is formed of similar materials in this embodiment. The upper layer 6 includes an upper surface 60 and a lower surface 61 and the lower layer 7 includes an upper surface 70 and a lower surface 71. The sensors 3 are mounted to a flexible printed circuit board 8, which is captivated between the layers 6, 7, and are connected to the output lead 5 by a respective printed wires 80. The zones Z1 , Z2, Z3... may, but need not, be marked on the surface of the detection pad 2, for example on either the upper layer 6 or lower layer 7.

The size and shape of the detection pad 2 are selected to substantially cover a mattress on which the patient is, or is to be, reposed. The detection pad 2 is or at least may be secured on top of a mattress (M, Figure 4), such that the lower surface 70 of the lower layer 7 of the detection pad 2 is in contact with and substantially covers the top surface of the mattress (M). The detection pad 2 may also secured to the mattress by means of elasticated edge EE in order to restrict undue movement of the pad 2 relative to the mattress after installation. In an alternative embodiment the sheet may be composed of a single layer of material and/or may be secured to the mattress by alternative means or incorporated therein. As seen in Figure 4, the mattress M may be mounted on a bed B comprising a frame F.

The sensors 3, illustrated in Figure 1 by a single element, may include one or more of, for example, pressure sensors, humidity sensors, temperature sensors, motion sensors and/or chemical sensors. Whilst the sensors 3 are shown to be connected to the control unit 4 via the flexible printed circuit board 8 through the output lead 5, the sensors 3 may be connected to the control unit 4 wirelessly or by some other suitable hardwire connection.

In some embodiments, the sensors 3 incorporate sensing devices of different types, which may be clustered together within each zone Z1 , Z2, Z3... Zn into sensor nodes and connected to the control unit 4 via a single connection or independent connections. The sensors 3 may be capacitive, resistive or conductive devices or any other type of sensor deemed useful for any particular application.

In this embodiment, the control unit 4 is configured to retrieve and store measurement data from the sensors 3 at regular intervals of, for example 300 seconds, 240 seconds, 180 seconds, 120 seconds, 60 seconds or less, e.g. 50 seconds, 30 seconds, 10 seconds, 5 seconds, 1 second or even in microseconds. In embodiments, the control unit 4 is configured to retrieve and store measurement data from some sensors 3 at different intervals to other sensors 3. In embodiments, the control unit 4 is configured to retrieve measurement data from the sensors 3 continuously, but may only be configured to store the data at predetermined time intervals or under certain conditions. The duration of the time interval is selected to ensure adequate monitoring of the sheet 2 (and hence the patient) whilst not generating an unnecessarily large database of information.

It is also envisaged that the measurement data may be retrieved or recorded only on or after detection of a predetermined condition or measurement or threshold, rather than at predetermined time intervals.

The control unit 4 includes a memory 40, a processor 41 and an alarm 42 (all of which may be housed in a common housing or two or three of which may be housed in separate housings). The alarm 42 in this embodiment includes both visual and audible alarms and may be mounted to or remote from the control unit 4. Measurement data received from the sensors 3 is stored in the control unit 4 in the memory 40, which may be partitioned into segments or sections corresponding to different types of sensors 3 and/or corresponding to different zones Z1 , Z2, Z3... Zn of the detection pad 2. The sensor data may be tagged, during transmission from a sensor 3 or sensor node with data or a signature relevant to the type of sensor 3 and/or the location of sensor 3 from which the data originated. The data may then be stored in the memory 40, for example in the relevant segment or section according to the signature tagged to the sensor data. The processor 16 implements an algorithm which compares received sensor data transmitted by the sensors 3 against data contained in a database. The database data may correspond to or be derived from sensor data measured previously from the patient being monitored or from another patient or group of patients. In some embodiments, the database data is an amalgamation of data from a group of patients, which may have been normalised to provide a baseline against which the measured data is to be compared.

Additionally, a therapeutic delivery device may be provided within or on the pad 2. The therapeutic delivery device may be operable to deliver a therapeutic agent which may be in the form of a chemical or biochemical agent or physical stimulus to the patient. The therapeutic delivery device may deliver a medicament, heat, cold, vibration, electrical stimulation and so on. For example the therapeutic delivery device may comprise a Transcutaneous Electrical Nerve Stimulation (TENS) device arranged to deliver TENS to an associated or adjacent area of a patient. The therapeutic delivery device may be operable to cause or encourage a patient to move or to otherwise stimulate at least a portion of the patient, for example to increase blood flow, for example local blood flow.

In use, a patient (not shown) rests on the detection pad 2 and the control unit 4 obtains or retrieves via output lead 5 sensor data relating to one or more conditions.

In one example, the system 1 may be used be subsequent to a surgical operation. In this example, the sensors 3 include pressure sensors, temperature sensors and moisture sensors and the control unit retrieves measurement data every 5 seconds. The data measured is therefore indicative of the position and temperature distribution of the patient across the detection pad and of the moisture absorbed into the detection pad. At predetermined time intervals, the control unit 4 retrieves pressure data from each sensor, which provides an indication over time of the patient's movements, their body temperature distribution and the presence of any moisture. The detection of patient's movements may be indicative of distress, wherein large movements are measured over short periods of time. The detection of elevated temperatures or rapid increases in temperature may be indicative of infection or other complications. The detection of moisture may be indicative of a patient sweating or bleeding, the latter being detectable by a localised rapid increase in moisture that then spreads across multiple zones. It will be appreciated that various thresholds may be established, which may include a combination of values, ranges rates of change and trends in each of these three measured parameters or in any combination. Indeed, the skilled person would appreciate that many more conditions or symptoms or states may be determined or detected from the measurement of these three parameters alone.

In this example, the system 1 is configured to initiate an alarm signal, which is sent to the alarm 42 in order to alert care staff to the situation. The alarm 42 may also include an indication of the suspected condition or state of the patient and/or a suggested course of action.

In another example, the system 1 may be used subsequent to a medicament being delivered to a patient by a medical professional. In this example, it is possible to monitor the effect of the medicament on the patient through use of the system 1. The system 1 may be programmed to detect one or more known side effects of the medicament. For example, where seizures are known to occur in some patients the rate of measurement data acquired from the pressure sensors may be adapted accordingly. In such instances, the control unit 4 may be configured to read measurement data continuously, but only record changes in measurements and alert care staff via the alarm 42 if a predetermined amount of movement, e.g. number of changes in the pressure sensors, is detected. Additionally or alternatively, temperature and/or moisture readings may also be retrieved, for example at regular intervals, to detect a feverish, 'normal' or comatose state.

It will be appreciated by those skilled in the art that sensor data from multiple sensor types may be stored together and the triggering threshold may correspond to a combination of predetermined threshold levels associated with multiple types of sensor readings.

In some examples, the sensor data received by the control unit 4 may compiled and stored in the memory 40 over an extended period of time in order that long term changes in the patient may be monitored. At least some of the data gathered or one or more parameters calculated therefrom may be displayed in a graphical manner on a display (not shown) such that a doctor or nurse or other medical professional may visually interrogate a record of the alterations in the patient which have been monitored. For example, the temperature changes of a patient may be monitored through use of the detection pad 2 rather than through conventional means. In some examples, sensor data from multiple detection pads 2 may be received or retrieved by a single control unit 4 or multiple control units 4 and compiled on the memory 40 of a single control unit 4 or transmitted or collected in a central memory, for example on a server, which may be a remote server in communication with the or each of the control units 4. In such examples, comparisons may be made between the measurement data collected from each mattress. As such, the effect of certain medicaments, for example, on multiple patients may be determined and used to establish or develop guidelines or one or more thresholds indicative of one or more symptoms associated with them.

It will be appreciated by one skilled in the art that the applications of such long term monitoring of patients need not be limited to the effects of medicaments on patient temperature but may also include, for example, the effect on patient movement, perspiration, chemical components of perspiration or frequency of urination. Additionally or alternatively the circumstances of monitoring may be, for example, after surgery, after food consumption, after medicament delivery, after sleeping, and so on.

Referring now to Figure 3, there is shown a monitoring system 100 similar to the monitoring system 1 according to the first embodiment, wherein like references depict like features that will not be described further herein. The monitoring system 100 according to this embodiment differs from the monitoring system 1 according to the first embodiment in that the system 100 includes a temperature control circuit 110, the control unit 4 includes an input device 142 and some of the zones Z1 , Z2, Z3... Zn include one or more transcutaneous electrical nerve stimulation (TENS) devices 120.

The temperature control circuit 1 10 includes a heat exchanger 11 1 and a tube 1 12 that forms a loop (not shown) through the detection pad 2 fluidly connected to the heat exchanger 11 1. The heat exchanger 1 11 is operatively connected to the processor 41 of the control unit 4. In use, when one or more temperature measurements detected by the sensors 3 fall outside a threshold range, the processor 41 causes the heat exchanger 1 11 to supply heated or cooled heat exchange fluid through the tube 1 12 to heat or cool the detection pad 2. The TENS devices 120 are located within the detection pad 2 and are distributed within the zones thereof in a similar manner to the sensors 3, as described above. The TENS devices 120 are operatively connected to the control unit 4 and are used to provide stimulation to a patient resting on the detection pad.

In use, a medical professional may activate one or more of the TENS devices 120 using the input device 142 of the control unit 4 in a specified sequence and/or for a specified duration of use. Additionally or alternatively, the control unit 4 may be configured or programed to activate the TENS devices 120 at one or more predetermined times and/or for one or more predetermined time periods. It will be understood by one skilled in the art that the TENS devices may be of particular benefit for treating comatose patients.

One or more of the TENS devices may be replaced or augmented with other physical stimulators (for example heaters, coolers, vibrators) or chemical or biochemical agent delivery devices, for example medicament effusers arranged to release a medicament onto the skin of a patient, medicament injectors arranged to inject a medicament through the skin of a patient, for example autoinjectors or injectors provided with one or more or an array of micro-needles.

It will be appreciated by those skilled in the art that several variations to the aforementioned embodiments are envisaged without departing from the scope of the invention. For example, the detection pad 2 may include only a portion that is segmented into zones Z1 , Z2, Z3... Zn, for example the detection pad 2 may comprise a peripheral region that is free of any sensors 3 or other devices. Additionally or alternatively, the detection pad 2 may include two or more areas having zones Z1 , Z2, Z3... Zn of different sizes, shapes and/or density. Several other arrangements may also be useful.

It will also be appreciated by those skilled in the art that any number of combinations of the aforementioned features and/or those shown in the appended drawings provide clear advantages over the prior art and are therefore within the scope of the invention described herein.

Claims

1. A monitoring system for monitoring a patient, the system comprising a detection pad and a control unit, the pad comprising a planar member with two or more zones or regions each of which comprises a sensor for measuring a parameter, e.g. the same parameter, associated with the state of a patient, wherein the control unit is configured to record, in use, over a predetermined period of time two or more measurements of said parameter measured by each sensor and to analyse the four or more measurements and/or compare them to a database in order to determine a state of the patient.

2. A detection pad, e.g. for use in the System of Claim 1 , the pad comprising a planar member with two or more zones or regions each of which comprises a sensor for measuring a parameter, e.g. the same parameter, associated with the state of a patient, the pad being operably connected or connectable to a control unit configured or configurable to record, in use, over a predetermined period of time two or more measurements of said parameter measured by each sensor and to analyse the four or more measurements and/or compare them to a database in order to determine a state of the patient.

3. A system or detection pad according to Claim 1 or 2, wherein the pad comprises three or more zones or regions each of which comprise a respective sensor for measuring or configured to measure the or a parameter.

4. A system or pad according to Claim 1 , 2 or 3, wherein the pad comprises one or more further sensors arranged to measure one or more respective further parameters.

5. A system or pad according to any preceding Claim, wherein in at least one of the zones the pad comprises a first sensor arranged to measure the parameter and a second sensor arranged to measure a second parameter.

6. A system or pad according to any preceding Claim, wherein the sensors of the first and second zone, and/or the sensors of a or the third and successive zones may be arranged to measure parameters comprising any one of motion or pressure or weight, e.g. wherein the sensor may comprise a pressure sensor or strain gauge or other motion sensing device; humidity, e.g. wherein the sensor may comprise a humidity sensor; moisture, e.g. wherein the sensor may comprise a moisture sensor; temperature, e.g. wherein the sensor may comprise a temperature sensor or thermocouple; and/or one or more chemical characteristics, wherein the sensor may comprise a chemical sensor.

7. A system or pad according to any preceding Claim, wherein the control unit is configured to receive or retrieve data, e.g. measurement data, from one or more or each sensor or all of the sensors, for example at predetermined time intervals, e.g. where the sensor or sensors are passive sensors.

8. A system or pad according to any preceding Claim, wherein one or more or each sensor or all of the sensors is or are configured to send or transmit data, e.g. measurement data, to the control unit, for example at predetermined time intervals, e.g. where the sensor or sensors are active sensors.

9. A system or pad according to any preceding Claim, wherein the control unit is configured to associate data received or retrieved, in use, with the zone from which the data was measured and/or with a time of receipt or retrieval.

10. A system or pad according to any preceding Claim, wherein the control unit includes a memory means that is partitioned or partitionable to provide separate and/or distinct memory sections or segments associated with each zone.

1 1. A system or pad according to any preceding Claim, wherein the data is tagged prior to or during transmission from the sensor or on or after receipt or retrieval by the control unit.

12. A system or pad according to Claim 1 1 , wherein the data tag may comprise data relating to the zone or node from which the data was measured.

13. A system or pad according to Claim 1 1 or 12, wherein the data tag is stored together with the data in or on the memory means.

14. A system or pad according to any preceding Claim, wherein the pad further comprises one or more therapeutic delivery means.

15. A system or pad according to Claim 14, wherein the one or more therapeutic delivery means is associated with a, some or all regions.

16. A system or pad according to Claim 14 or 15, wherein the therapeutic delivery means may be operable to deliver a stimulus to the patient, for example a chemical biochemical or physical stimulus to the patient.

17. A system or pad according to any preceding Claim, wherein the pad comprises a sheet, which may comprise one or more layers, and wherein the two or more sensors are mounted or located on or in the sheet, e.g. a layer of the sheet.

18. A system or pad according to any preceding Claim, wherein the control unit is configured or configurable to generate an alert or alert an authority, for example if the state of the patient is determined to correspond to a vulnerable state, e.g. if one or more thresholds are approached or exceeded.

19. A system or pad according to Claim 18, wherein the one or more thresholds comprise threshold value(s) associated with the measured parameters or their rate of change and/or said one or more thresholds comprise threshold value(s) associated with calculated parameters, which are derived or are deriveable from one or more of the measured parameters.

20. A hospital bed comprising a support frame, a mattress and a system or detection pad according to any preceding Claim, the detection pad being deployed over the mattress.

21. A method of monitoring a patient, the method comprising the steps of positioning a patient on a detection pad with two or more zones or regions each of which comprises a sensor for measuring a parameter, e.g. the same parameter, associated with the state of a patient, recording over a predetermined period of time two or more measurements of said parameter measured by each sensor and analysing the four or more measurements and/or compare them to a database in order to determine a state of the patient.

22. A method of reducing the likelihood of a person lying in a bed suffering an injury whilst lying in the bed, the method comprising providing on or in the mattress comprising part of the bed a detection pad having two or more zones or regions each of which comprises a sensor for measuring a parameter, e.g. the same parameter, associated with the state of the person lying in the bed and taking readings from each sensor to determine the parameter and, in accordance with the readings issue an alert to a care provider and/or automatically delivering a stimulus to the person using a therapeutic delivery means associated with the pad, or at least associated with a zone or region of the pad.

23. A method according to Claim 21 , comprising delivering from the therapeutic delivery means a therapeutic agent selected from a medicament, heat, cold, vibration, electrical stimulation.

24. A method of monitoring the effect of administering a medicament to a patient, the method comprising locating a patient on a detection pad, which detection pad has two or more zones or regions each of which comprises a sensor for measuring a parameter, e.g. the same parameter, associated with the state of the person located on the pad and administering a medicament to said patient located on the pad and taking readings from each sensor to determine the parameter to monitor the condition of the patient in response to administration of the medicament.

25. A method according to Claim 24, comprising locating plural patients on respective plural detection pads to monitor the effects of administering a medicament to said plural patients to thereby compile a data set of response in relation to said plural patients.