WO2014172756A1

WO2014172756A1 - Pressure sensing medical device system for remote patient monitoring and prevention of pressure ulcers

Info

Publication number: WO2014172756A1
Application number: PCT/AU2014/000473
Authority: WO
Inventors: Keenan MAY; Elizabeth REDMOND; Simon TRUDE; Matthew Harris
Original assignee: Pressurx Pty Ltd
Priority date: 2013-04-23
Filing date: 2014-04-23
Publication date: 2014-10-30
Also published as: AU2014256849A1

Abstract

A patient movement monitoring system comprising sensing hardware (100) which can be in the form of a sheet or planar member that is placed under a patient who may be susceptible to pressure ulcers due to lack of movement. The sensing hardware can comprise two or more energy harvesting devices (102) with each energy harvesting device (102) being configured to output a current in response to detected patient movement. Each energy harvesting device (102) can comprise a piezoelectric device. The system can also comprise a wirelesss transmitter (105) that can be powered by at least one of the currents and on receipt of said currents transmits at least one data packet representative of the detected movement, a network that communicates the respective currents from the energy harvesting devices to the wireless transmitter (105) and a remote receiving device (106) or computer running sensing software (108) that processes the at least one data packet and provides an output of said data for analysis.

Description

"Pressure sensing medical device system for remote patient monitoring and prevention of pressure ulcers"

Field of the Disclosure

The present disclosure relates to the field of medical device systems. More specifically, this disclosure relates to a patient monitoring system that can be used in a vast array of applications within a range of settings including a hospital, an extended care facility, a hospice, a nursing home, a rehabilitation centre, or in a home setting for subjects ranging from infants to elders.

Background

Many patients who are bed-bound or otherwise immobile for long periods can suffer from pressure ulcers. Pressure ulcers can be generated by prolonged application of pressure to sensitive body parts, including the sacrum, shoulders, and heels. Nurses and other medical staff are trained to physically monitor and examine patients at risk of pressure ulcers and rotate or otherwise move patients when required to avoid the formation of pressure ulcers. However, as staffing costs rise and patient loads have increased, the ability of nurses and other medical staff to adequately monitor all patients under their care can suffer.

Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present disclosure as it existed before the priority date of each claim of this application.

Summary of the Disclosure

Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps. In one aspect, there is provided a patient movement monitoring system comprising:

sensing hardware comprising two or more piezoelectric energy harvesting devices, wherein each energy harvesting device is configured to output a current in response to detected patient movement;

a wireless transmitter; and

a network that communicates the respective currents from the energy harvesting devices to the wireless transmitter;

wherein the wireless transmitter is at least partially powered by at least one of the currents and on receipt of said currents transmits at least one data packet representative of the detected movement.

In one embodiment of this aspect, the system can comprise a receiving device that can receive said at least one data packet. The receiving device can process the at least one data packet and provide an output of said data for analysis of the detected movement.

In another aspect, there is provided a patient movement monitoring system comprising:

sensing hardware comprising two or more energy harvesting devices, wherein each energy harvesting device is configured to output a current in response to detected patient movement;

a wireless transmitter;

wherein the wireless transmitter is at least partially powered by at least one of the currents and on receipt of said currents transmits at least one data packet representative of the detected movement; and

a remote receiving device;

and further wherein the remote receiving device processes the at least one data packet and provides an output of said data for analysis.

In this aspect, one, two or all of the energy harvesting devices can comprise piezoelectric energy harvesting devices. In the above aspects, the sensing hardware can comprise one or more planar members.

In a still further aspect, there is provided sensing hardware for use in a patient movement monitoring system, the sensing hardware comprising:

a planar member suitable for placement relative to a patient;

two or more energy harvesting devices, wherein each energy harvesting device is configured to output a current in response to detected patient movement;

a wireless transmitter; and

a network that communicates the respective currents from the energy harvesting devices to the wireless transmitter.

In one embodiment of the above aspects, the wireless transmitter is wholly powered by said at least one of the currents output by the energy harvesting devices. In another embodiment, the wireless transmitter and/or other components of the sensing hardware are only partially powered by said at least one of the currents output by the energy harvesting devices. In this latter embodiment, the wireless transmitter can be wholly powered some of the time and only partially powered at other times. Alternatively, it can be partially powered all of the time. Where the output of the energy harvesting devices provides only partial power, supplementary power can be provided by one or more auxiliary power sources. The one or more auxiliary power sources can be a component of the sensing hardware. In one embodiment, the auxiliary power source can comprise one or more batteries, including rechargeable batteries. The batteries can be removably mounted to the sensing hardware. In another embodiment, the auxiliary power source can result from the sensing hardware be electrically connectable to mains power. In this embodiment, the sensing hardware can have the energy harvesting devices, one or more on-board batteries as well as being connectable to mains power. The sensing hardware can further comprise a microcontroller. Where the sensing hardware includes one or more auxiliary power sources, said other component of the sensing hardware can comprise a microcontroller. Where present, the microcontroller may process the data packets prior to transmission by the wireless transmitter. The planar member can have dimensions such that it will detect various types of movement of a patient when the patient is placed on the planar member or in another suitable position relative the patient. The present disclosure provides a system and devices that can be used to determine if patients are being left stationary for undesirable lengths of time in a care setting wherein pressure ulcers may form. The system can be used in both an inpatient hospital setting as well as in an outpatient setting, including nursing homes, hospices, rehabilitation centres and patient's homes. Its application may be used to prevent pressure ulcers for any immobilized or partially immobilized patient, including bedbound, paraplegic, and quadriplegic individuals. While the system can be used with one patient, it can also be used with two or more patients simultaneously thereby allowing a caregiver to monitor more than one patient at any time. It will be appreciated that the patients need not be in the same setting. For example, a single caregiver could be monitoring multiple patients in separate settings using the system as defined herein. The system is designed to be relatively low cost. At least the sensing hardware, or portions thereof, can also be designed for single use and therefore be disposable. In one embodiment of the defined aspects, the sensing hardware can be provided with no power or data wires or cables extending therefrom. This thereby providing a relatively easy-to-install medical device. Furthermore, the sensing hardware of the system can be self-powered and thus does not require the maintenance required by existing sensing devices that operate on batteries or external power supply.

In a further embodiment, the planar member of the sensing hardware can be placeable atop an existing bed, wheelchair, or other sitting or lying surface. One arrangement of the invention can be to place the planar member of the sensing hardware atop a mattress, hospital bed, or chair (including stationary and wheeled chairs). Furthermore, the planar member can be relatively thin relative its longitudinal and lateral dimensions. It can also be relatively flexible, foldable or conformable to other surfaces such as the surface of a mattress.

In another embodiment, the planar member can also be embedded within a cushion or other structure of either a mattress or a chair. The planar member can be positioned closer to the top of the cushion than the bottom, with the top being understood to be the surface that receives the patient.

The system can use sensing software. Such software can be used on the receiving device as defined. The receiving device can be a mobile device such as a smartphone, tablet computer, laptop computer, desktop computer or other suitable processing device. In one embodiment, the sensing software may be used to alert a person, for example a patient's care-giver or the patient themselves, on conditions, events, or status derived from the generated data and may also be used by multiple people and on multiple platforms to locally or remotely monitor generated data from one or more hardware devices. In yet a further embodiment, the receiving device can be enabled to connect and transmit the received data to a cloud-based server location where the data can, if necessary or desirable, be analysed using web-based or other applications. Use of such a cloud-based service, can allow other persons to access the uploaded data, whether it be in an unprocessed, semi-processed or fully processed form. It also facilitates a person to review the uploaded data from a patient in a location that is remote the location of the person.

The prevention of pressure ulcers can be accomplished by the system reporting the movement and pressure status of patients and at-risk body parts to caretakers and to patients themselves in real-time so as to encourage movement and prevent the development or worsening of pressure ulcers or the progression of existing ulcers.

Brief Description of Figures

Figure 1 depicts one embodiment of the sensing hardware (100). More specifically, Figure 1 depicts an exploded view of the sensing hardware (100) comprising a planar member formed of two layers of relatively pliable material (101 ) encasing an inner layer (1 10).

Figure 2 depicts an embodiment of the inner layer (1 10) with a first arrangement of the energy harvesting devices ( 102) disposed in linear sensing zones ( 104) and which are attached to conditioning electronics circuit(s) (103) and a wireless transmitter (105) using a network of conductive elements, which can be provided by wires or printed conductive inks (1 1 1 ). Figure 3 depicts another embodiment of the inner layer (1 10) with a second arrangement of the energy harvesting devices (102) disposed in rectangular sensing zones (104) and which are again attached to conditioning electronics circuit(s) (103) and a wireless transmitter (105) using a network of conductive elements, which can be provided by wires or printed conductive inks (1 1 1 ).

Figure 4 depicts yet another embodiment of the inner layer (1 10) with a third arrangement of the energy harvesting devices (102) and which are again attached to conditioning electronics circuit(s) ( 103) and a wireless transmitter (105) using a network of conductive elements, which can be provided by wires or printed conductive inks ( 1 1 1 )

Figure 5 depicts an embodiment of the patient monitoring system, including an embodiment of the sensing hardware (100) and its use in conjunction with sensing software (108) running on a receiving device (106), a wireless network (1 13), and an online database (107).

Figure 6 depicts a still further embodiment of the sensing hardware (100), including an arrangement of the energy harvesting devices (102) in circular sensing zones. The devices (102) are again attached to conditioning electronic circuits (103), that can send conditioned input to a microcontroller (109), that can be powered by a power source (1 14), and controls the data output to an alarm (1 16) and a Wi-Fi module. Each device can be connected using a conductive element (1 1 1). Figure 7 depicts an alternative embodiment of the sensing hardware (100) as part of the entire system, including its communication using a wireless network ( 1 13) to an online database(107) and furthermore to the sensing software (108) without using a receiving device (106) as depicted in the previous embodiments. Detailed Description of Exemplary Embodiments of the Disclosure

Various possible embodiments of the system as disclosed herein are depicted in the drawings. Figure 1 depicts one embodiment of the sensing hardware (100) comprising a planar member formed of two layers of relatively pliable material (101 ) encasing an inner layer (1 10). The planar member is depicted with its layers separated for the purposes of clarity and to assist in understanding how the sensing hardware is formed. It will be appreciated that the layers (101 and 1 10) will typically be formed into an integral member. The inner layer ( 1 10) can also be formed of a pliable material and also can be formed of the same pliable material or materials as that comprising the two layers of pliable material (101 ). While depicted with a bend formed therein the sensing hardware (100) is depicted in the manner to again demonstrate the pliable nature of the sensing hardware and its suitability for placement on a mattress, particularly a hospital mattress. It will be appreciated that the sensing hardware (100) can adopt other configurations from that depicted, including lying fiat or indeed be folded in other manners from that depicted.

The inner layer (1 10) can be a device that captures and transmits movement of a body or body part as data points or in data packages. While depicted and described as an inner layer, it will be appreciated that another layer of the sensing hardware, for example an outer layer, an upper layer and/or an inner layer could comprise the device that captures and transmits movement of a body or body part as data points or in data packages. In the depicted embodiment, the inner layer (1 10) comprises a relatively pliable planar member having multiple energy harvesting devices (102). One, some or all of these energy harvesting devices (102) can comprise piezoelectric energy harvesting devices. The inner layer (1 10) also comprises a conditioning electronics circuit (103), a microcontroller (109), a wireless transmitter (105), with all of these positioned within or on the relatively pliable planar member of the inner layer (1 10).

As depicted in the embodiment of Figures 1 and 2, one, some or all of the energy harvesting devices ( 102) can comprise piezoelectric devices. Such piezoelectric devices can include piezoelectric material that may be ceramic-based, such as lead zirconate titanate (PZT) or other suitable ceramic materials, or polymer-based, such as polyvinylidenefluoride (PVDF) or other suitable polymeric materials. Such piezoelectric devices are arranged to convert the kinetic movement (rolling, repositioning, sitting, standing, and/or any applied force to the material) of a patient's body into electrical energy. One, some or all of the energy harvesting devices ( 102) may be formed from other devices such as solar thermoelectric, pyroelectric, or electromagnetic materials.

The energy harvesting devices (102) depicted in Figures 1 and 2 can generate current as a result of patient movement atop the devices. Such current can be used wholly or in part by the wireless transmitter (105).

In the depicted embodiment, the provision of the current can result in the wireless transmitter (105) generating a pulse or more than one pulse of energy that defines a data point or points and which can be later analysed to characterize the movement of a patient.

Instead or in addition to their other functions, the energy harvesting devices (102) can be used as an energy source for recharging batteries used by the sensing hardware (100).

Instead or in addition, the current pulse(s) from the energy harvesting devices ( 102) may be used as sensor input to an input pin of the microcontroller (109). The current pulses output by the energy harvesting devices (102) can be used as representational data points that describe the movement of a patient. Detail 2.1 and 4.1 in Figures 2 and 4, respectively, depict how the energy harvesting devices (102) can be individually connected using a conductive element (1 1 1 ). The conductive elements can be wires or printed conductive ink. The conditioning electronics circuit (103) where provided can be used for amplification, attenuation, filtering, converting, range matching, impedance matching, isolation and any other processes required to make the energy harvesting device(s) (102) energy output suitable for powering the low-power wireless electronics after conditioning and/or for providing a suitable sensing signal for an input port to a board of the wireless transmitter (105).

The conditioning electronics circuit (103) may be responsible for converting the analog signal to a digital signal that can be then sent to a microcontroller (109) of the sensing hardware (100). The energy harvesting devices (102) may be coupled to the conditioning electronics circuit( 103) using a conductor such as one or more electrically conductive wire(s), printed conductive ink, a printed flexible circuit board, or another conductive connective component. There may be any number of individual conditioning electronics circuit(s) (103) on the sensing hardware (100). Figures 2 and 3 illustrate different arrangements and numbers of conditioning electronics circuit(s) ( 103) in the sensing hardware ( 100).

While the sensing hardware (100) does not require a microcontroller (109) to be directly used in conjunction with the energy harvesting device(s) (102), conditioning electronics circuit(s) (103), and wireless transmitter (105), the sensing hardware (100) in one embodiment can include a microcontroller (109). An example of such an embodiment is shown in Figure 6.

Where present, the microcontroller (109) can be used for processing input signals (for example data points) and controlling output signals. The microcontroller (109) may be chosen from any available commercial microcontroller (109) products that have a central processing unit, clock, read only memory (ROM) wherein a software program can be stored, a random access memory (RAM), and/or input and output (I/O) ports. The microcontroller (109) may also include but is not limited to analog-to-digital converters, digital-to-analog converters, in-circuit programming and debugging support, other serial communications interfaces like I²C, Serial Peripheral Interface, and Controller Area Network for system interconnect, and peripherals such as timers, event counters, PWM generators, and watchdog. A USB port may be used to communicate information from the microcontroller (109) on the sensing hardware ( 100) to another USB device. The microcontroller (109) may also include an external/removable storage device such as additional ROM, EPROM, EEPROM or Flash memory, wherein data can be stored for access at a later date.

The wireless transmitter (105) can be a wireless transmitting module that can be used in various embodiments of the sensing hardware (100). The wireless transmitter ( 105) can in certain embodiments act as a wireless receiver. This device may be comprised of standard electronic components on a printed circuit board (PCB) or printed electronic components on a flexible circuit board. The wireless transmitter ( 105) can have a wireless radio that can be a standard or printed component and antennae that may be printed using the same technique as the conductor described in the conditioning electronics circuit (103) description. The antennae may encompass the entire area of the sensing hardware (100) to increase its range. The wireless transmitter (105) can be used to transmit data points associated with each pulse of energy from an energy harvesting device (102). Furthermore, the wireless transmitter may be an add-on module, such as a wireless shield, to the microcontroller (109). This enables any data on the microcontroller (109) to be communicated over the shield's wireless radio.

Turning back to Figure 1 , this figure illustrates two layers of pliable material (101 ) laminating the inner layer (1 10) which is understood to contain the devices (102- 105). In this embodiment, the body of thhouse the energy harvesting device (102). conditioning electronics circuit (103), wireless transmitter (105), and other electronics used in their assembly.

As depicted in Figure 6, the pliable material making up the inner layer (1 10) may also house other components listed in alternative embodiments such as a microcontroller (109).

The pliable material making up the inner layer (1 1 may also house additional control devices connected to the microcontroller (109), such as a LCD, switches, buttons, and alarm devices such as a speaker, vibrator, or light.

The pliable material of the inner layer (1 10) can comprise or may resemble a cushion, pad, matt, or sheet that includes of many layers or a single piece of material. The pliable material can serve to encase and protect all electrical components from environmental conditions such as moisture. The pliable material also may provide concealment wherein the embedded components are not physically perceivable to the patient.

All of the figures depict how the pliable material of the layer (1 10) results in the layer having suitable dimensions and an ability to suitably flex. The pliable material may be encased in other layers of the same or different material. For example, the pliable material can be encased in a fabric, a plastics material, or a rubber. This can be done in the form of a case, fitted sheet, or another shape able to form an enclosure. This encasing or other layers may be washable or replaceable to provide sterility, an antifungal feature, or an antimicrobial feature, or to add protection to the device, or assist in its placement. For example, the second enclosure may be a waterproof slip that encompasses the entire device. The second enclosure may serve as a disposable cover for the pliable material used in layer ( 1 10).

Figure 2 depicts how the energy harvesting device(s) (102) can be arranged into sensing zone(s) ( 104).

A sensing zone (104) can be made up of one or more energy harvesting devices (102) located in a specific area of the sensing hardware (100). Figures 2, 3, and 4 show examples of different sensing zone (104) configurations.

Each sensing zone (104) may include any number of energy harvesting devices (102) and one or more conditioning electronics circuits (103). Each sensing zone (104) can have its own input to the wireless transmitter (105) and thus correlates to uniquely identifiable data points.

The sensing hardware (100) may contain one or more sensing zones. For example, the sensing hardware (100) may include six sensing zones (104) of which each corresponds to an input on a wireless transmitter (105). A sensing zone (104) may be sized or shaped to match an area of a patient's body. For example, a sensing zone (104) of the sensing hardware (100) may contain a unique array of energy harvesting devices (102) spatially configured to effectively receive forces from a specific area of a patient's body when the patient moves. Sensing zones (104) may be associated with different body parts and may have to be arranged in different configurations across one device in order to accurately sense movement as well as harvest enough energy to power the wireless transmitter (105).

The wireless transmitter(s) (105) on the sensing hardware (100) may push data points directly to a receiving device (106) (see for example Figure 5). The receiving device (106) may be a computer, such as a desktop computer, laptop computer, or a mobile device, such as a tablet, smartphone, and other handheld computers that run application software. The wireless transmitter(s) ( 105) of sensing hardware (100) and the computer to which it communicates can operate on the same wireless protocol such as Bluetooth or Wi-Fi. Furthermore, the wireless transmitter(s) (105) on the sensing hardware ( 100) may push data points to a wireless data receiver device that can be enabled to connect and transmit the received data points to the Internet. Shown in Figure 5, the receiving device (106) may include a wireless receiver that receives data points on the same wireless protocol used by the wireless transmitter (105) on the sensing hardware (100), a processing platform such as a microcontroller ( 109), and a method of communication to forward the data received to a web-based or local database (107). The forwarding of data points by the receiving device (106) may be done using a wired connection like a USB, Ethernet, or FireWire™ port to connect directly to an internet source, a Wi-Fi module to connect to an existing Wi-Fi network or to create an adhoc network wherein a remote device may connect to the internet, and a GPRS or other telecommunications technology module to communicate to the internet through a cellular network. The receiving device ( 106) pushes received data points to a database (107) using the internet connection. The receiving device (106) may be powered by batteries or any external power source, including mains power.

The sensing software (108) can access a database (107) where the data from the receiving device (106) can be stored. By processing the data points, the sensing software ( 108) may turn the data points into information. For example, the data points stored on the database (107) requires processing, such as aggregating, interpreting, parsing, and organizing to make the data into usable information. Furthermore, using graphic, video, and textual visualizations, provided by the sensing software, information may then be contextualized. The contextual ized information may help the users understand the condition of the patient. The purpose of the sensing software (108) can be to create knowledge from the original data generated by sensing hardware

(100) and make it available to a remote user or multiple people at one time. The knowledge received by the user of the sensing software may provide insight into the treatment or prevention of pressure ulcers.

The system as defined herein can comprise the sensing hardware ( 100), sensing software (108), and a device that runs and displays the sensing software ( 108) can be required to use the system in one embodiment.

The one embodiment of the sensing hardware (100) includes the pliable material

(101 ) enclosing any number of sensing zones (104) (including any number of energy harvesting devices (102), conditioning electronics circuit(s) (103), and wireless transmitter(s) (105)). The sensing hardware ( 100) operates when a patient is positioned on top of it and applies pressure, by moving their body, on the device. The sensing hardware (100) can be attached to a surface, such as the top of a mattress of any size, a chair, or a wheeled chair or be incorporated in a cushion comprising a mattress, chair or the like.

The enclosure around the inner layer (1 10) may have an ability to attach itself to a surface. This enclosure may be in the form of a fitted sheet wherein the enclosure wraps around the top and sides of a mattress, holding the device in position on the top surface. Another way the sensing hardware (100) may be fixed in place can be by using hook and loop fasteners (for example Velcro™), another abrasive matching material, or an adhesive that causes the various layers to stick to one another.

In the one embodiment of the sensing hardware ( 100), pressure applied lo a sensing zone (104) by the movement of a patient's body results in the energy harvesting devices (102) generating and sending a charge to its conditioning electronics circuit (103). The conditioned charge from the conditioning electronics circuit ( 103) can be then sent to the sensing zone's (104) input port on the wireless transmitter (105). The conditioned charge instantaneously powers the wireless transmitter (105) and sends a data point defining the conditioned charge as a data point relative to the movement that generated the original pulse of energy.

The wireless transmitter (105) may also perform basic processing tasks to further define the conditions of the event in that data point. The data point may either be a binary, analog, or digital piece of information relating to activity. This may be done, for example, in three ways:

a. The wireless transmitter (105) and conditioning electronics circuit (103) can be coupled with each sensing zone (104) of energy harvesting devices (102). When energy is available from a force applied to an energy harvesting devices (102), it passes through the conditioning electronics circuit (103) without any storage to the wireless transmitter ( 105) and a data point can be immediately transmitted.

b. The wireless transmitter (105) of a sensing zone ( 104) has separate analog or digital input ports. In this case, charges generated from an energy harvesting device (102) are split into two paths. On one path the conditioning electronics circuit (103) transmits the energy available to the trace, on the wireless transmitter (105) responsible for supplying power to the wireless radio. When the radio can be ready to send out the data received through the sensing zone's (104) input ports, adequate conditioned energy can be available for transmission. This energy can be either used to transmit a data packet with information relating to the current event or the next event. The second path reads the unconditioned charge as an analog input on the microcontroller. The wireless transmitter ( 105) transmits the analog input (a voltage range between zero and the maximum output of an energy harvesting device (102)) in the wireless data packet associated with the energy generated by that event or the prior event.

c. Each energy harvesting device (102) can be layered with an additional piece of piezoelectric or other phase changing, flexible sensing material. This additional sensing layer can be uncoupled with the energy harvesting devices' (102) conditioning electronics circuit (103). This additional sensor provides an open circuit voltage profile (an analog signal) relative to a force applied to a sensing zone (104). This analog signal from the additional sensor can be used as an analog input to the wireless transmitter (105) input ports to which the energy harvesting devices (102) supply their power. This can be similar to the examples listed above wherein data and power input occur simultaneously from one specific zone, however in this case, additional sensing layers are added to the device.

The sensing hardware (100) may also include an active or passive RFID tag or a barcode or QR code. This RFID tag or code may be used for asset tracking and/or patient tracking.

The receiving device (106) can receive data points from any number of wireless transmitter(s) ( 105). For example, two or more sensing hardware (100) devices, used for two or more patients, may transmit data points to a single receiving device (106). The receiving device (106) may also only receive data points from one sensing hardware (100) device. Each data point from sensing hardware (100) devices can be uniquely identifiable thus each data point received identifies the sensing hardware (100) device and from which specific sensing zone (104) that data point originated. The receiving device ( 106) can upload and write each data point to a database

(107). In one embodiment of the system, the database (107) can be hosted on a cloud- based server. The database (107) allows for any sensing software (108) with proper database (107) authentication, such as an API key, to read or download specific data points. The receiving device (106) may also write each data point to a local database

( 107).

The sensing software (108) can connect to any number of database(s) (107) where data points from any number of sensing hardware (100) devices are stored. This allows a user of the sensing software (108) to access any number of patients using a sensing hardware (100) device.

The sensing software ( 108) parses the requested data points and displays them as useful information to the user. For example, the sensing software (108) may convert the data points into graphs or diagrams in a user interface to easily convey the amount of data points and their sensing zone (104) over time for a patient. Furthermore, the sensing software (108) allows a user to view historical or real-time information. For example, a user may request to view information on a patient for their entire duration of time using the sensing hardware (100). They may also access information of a historical patient with similar biometrics and medical condition to predict behaviour and prognosis.

The sensing software's (108) user interface provides a user with the ability to modify its settings. For example, the user interface allows the user to add, remove, group, and organize patient information. For example, a first nurse may choose to monitor 5 of 10 active sensing hardware (100) devices and a second nurse may monitor the remaining 5 active sensing hardware (100) devices by selecting these specific devices in the settings of the sensing software ( 108). Additionally, the settings in the sensing software (108) may allow a user to change display characteristics of the user interface, such as how each or all devices are displayed. Data entry also enables a new way of documenting and categorizing patient information such as duration of stay, patient room and location, and other relevant details regarding their admission. The sensing software (108) also allows a user to view and/or monitor multiple devices and patients in one display. This may be done using a map feature in the software, wherein each device can be located on a map and given a color denoting the state of the patient. The sensing software (108) may also provide the ability to perform basic operations wherein selected data can be used to discover and communicate meaningful patterns. These analytics may be visualized in the user interface using any kind of graphic data representation. Another example of how the sensing software (108) operates can be as an alarm for users. The sensing software ( 108) uses the generated information to simulate an alarm when a lack of data can be generated by a monitored sensing hardware (100) device. The settings of the sensing software (108) may define rules for interpreting data points wherein, for example, a maximum time interval between the creation of each data point of the same sensing zone (104) may be defined to trigger an alarm in the sensing software (108) if the time interval were to elapse. The maximum time interval represents the maximum amount of time a person should remain in a position without moving. The maximum time interval may be uniquely defined for each sensing zone (] 04) of a sensing hardware (100) device. The alarm can be designed to alert the user of the sensing software (108) that the user needs to move or be moved and the movement may be pinpointed to a specific sensing zone (104). Moving the patient before or when an alarm can be triggered may prevent the development of pressure ulcers in the patient. In the case of infant and baby crib mats, the sensing software (108) can be designed to alert the user when an infant has not moved for an extended period of time or when the infant has moved irregularly like rolling over.

Another example of how the sensing software ( 108) uses the data can be creating a real-time interface wherein the data can be arranged or represented by text and graphics. This interface informs users or persons monitoring the user of the recorded movement over a set period of time. For example, it may be programmed to have a counting clock relative to each zone that displays the time difference between the last movement and the current time. Another example of a real-time graphic representation of user-generated data can be displaying the sensing zone(s) (104) of the sensing hardware (100) that is being monitored as a heat mat. The heat map displays a color gradient representing user movement over an elapsed time. When a given period of time has elapsed, the high-risk zone can be represented by the alert color, such as red, and the low-risk zone can be represented by another, such as green or white. A second unique feature of the sensing software (108) can be its ability to collect and aggregate information on a patient's physical movement and to use this information to generate reports on how this patient may or may have not been subjected to patient monitoring that caused or prevented pressure ulcers. One use for such collective information includes the ability to have it imported into patient and hospital records to provide evidence of patient movement to track pressure ulcer treatment and prevention efforts over time. This information could be used for future or retrospective clinical studies.

For example, the sensing software (108) may be used to export any information or raw data. Information or raw data may be exported as a static document or a real- time stream of data. A static document may contain information representing any number of patients. The contents of the document may include any information generated by the sensing software (108), such as sensing zone (104) data points, events such as alarms, and trends generated using the data points. The static export may be created as any suitable file, format for conveying the desired information such as a raster or vector drawing of a chart, a spreadsheet or any configuration of tabulated data, or text document. A nurse may use the sensing software (108) to generate a spreadsheet report based on the activity monitored in a specific sensing zone (104) of a sensing hardware (100) device for any given range of time. Exporting a stream of data may use a COM port, such as a USB port, to transfer the data to another device, such as a microprocessor. For example, the data stored in the sensing software (108) database

(107) may be pushed to another device, such as an alarm device, if connected using a wired connection or if each of the devices being used to access the sensing software

(108) and the receiving device are internet-enabled. In aggregate the data generated by individual devices can be used paired with actual events of pressure ulcer formation to analyze the percentage rate of formation within each facility. This data can be used to compare multiple facilities. The historical data can also be used in a court of law or other tribunal to reference a patient's movement and/or mobility.

The sensing software (108) can be able to retrieve all of its data points through an Internet connection thus a user may access the software from any location and thereby making patient information available to any number of people regardless of their physical location. For example, nursing staff at a hospital or nursing home may view streaming data at the same time as do friends and family at home given the proper authentication credentials. Furthermore, the sensing software (108) may monitor the data points of any number of active sensing hardware ( 100) devices. The provision of light emitting diodes (LEDs) or other indicating devices can be used as indicators of the functionality of the sensing hardware ( 100).

In one embodiment, the LEDs can be provided on an outside face of the sensing hardware (100). The LEDs can correspond with the sensing zone (104) of the energy harvesting devices (102) and can turned on for a pre-set time interval when the corresponding wireless transmitter (105) is powered. This process ensures that the energy harvesting devices ( 102) are effectively communicating to the on-board electronics. Furthermore, if the wireless transmitter ( 105) includes a USB port, connecting the device to a computer or other device using a USB may also test the functionality. The computer or other device runs software showing the data points collected by the sensing hardware (100).

Configuring the sensing software ( 108) to view a sensing hardware (100) device's generated data points requires the user to first connect the sensing software (108) to the appropriate database (107). Each sensing hardware (100) device can have a unique ID associated with its wireless transmitter(s) (105). Authentication, such as a key, to access that device can be generated and used to access its database ( 107). This allows for each sensing hardware (100) device to be recognized individually by the sensing software (108).

One feature of the system as defined herein can be that its sensing hardware (100) may be completely self-powered. The sensing hardware (100) does not require batteries or any external power source to collect and transmit data from a patient as the user-generated energy from the energy harvesting devices (102). Another feature of the invention can be its integration with a mobile health application, the sensing software (108), that enables remote patient monitoring to any authenticated user, whether they be based in the facility or outside thereof. Furthermore, a feature of the invention can be its ability to generate trends based on collected data and to export these trends to a document to be used at a later date such as for legal purposes or for medical research.

An alternative embodiment of the system can be based on changes to the sensing hardware ( 100). Such an alternative embodiment of the sensing hardware (100) does not eliminate ways in which it may be used but rather allows for new features to be added. Shown in Figure 7, an alternative embodiment of the sensing hardware (100) removes the receiving device ( 106) and includes a microcontroller ( 109). The incorporation of a microcontroller (109) adds the ability to process energy pulses from the energy harvesting devices (102) using software embedded in the sensing hardware (100). For example, depressing the sensing hardware (100) in any sensing zone ( 104) creates an energy pulse from one or more energy harvesting devices (102) that can be sent to the sensing zone's (104) conditioning electronics circuit (103). The energy pulse can be then released as a digital or analog signal from the conditioning electronics circuit (103) to one of the microcontroller's (109) input ports. Also, the first analog charge from the energy harvesting devices (102) may be input directly to the microcontroller ( 109) wherein the microcontroller (109) reads its voltage as a range. The energy pulse, whether digital or analog, can be assigned a timestamp and a unique identification based on the input pin and thus the zone in which it originates. Each signal originating from the charge from an energy harvesting device (102) can be a data point. The generated data points are used by the microcontroller's (109) software.

The embodiment depicted in Figure 7 may be assembled using an On/Off switch with a power source that powers a microcontroller (109) that controls the electronics in the sensing hardware (100). In the case of not using an On/Off switch, the microcontroller (109) may enter a sleep mode. For example, if the microcontroller ( 109) does not receive any energy input from the energy harvesting devices (102) and within a pre-set time interval, defined by the user, the microcontroller ( 109) will decrease its amount of processing to conserve energy by using a hardware interrupt wherein the microcontroller (109) will resume normal operation if a signal is detected from any of the energy harvesting devices (102).

The microcontroller (109) and its corresponding electronics in this alternative embodiment of the sensing hardware (100) may be powered by a power source ( 1 14) such as a battery that may be recharged, an AC adapter that draws power from a wall outlet, or by drawing power through a USB connection. Another way the device may power itself can be using the excess energy harvested from the forces applied to the energy harvesting devices (102). For example, energy generated by the energy harvesting devices (102) may exceed the amount needed as sensing input to the microcontroller (109). This excess energy may be stored in the conditioning electronics circuit ( 103) and used to power the microcontroller (109). The microcontroller ( 109) described may communicate its generated data to a remote device, such as a computer, through a USB connection. The USB may also be used to upload software to the microcontroller ( 109). This alterative embodiment of the sensing hardware (100) may also include a Wi-Fi module (1 1 5) enabling any processed or raw data from the microcontroller ( 109) to be sent in wireless data packets, including the characteristics of data points, alarm events, or any other processed information. The wireless communication may use any wireless protocol including ANT™, Wi-Fi, Bluetooth™, IrDA, NFC, EnOcean™, Zigbee™, or a cellular telecommunications technology such as GPRS. The inclusion of the Wi-Fi module (1 15) enables the microcontroller (109) to push information directly to an Internet connection.

The software of the microcontroller (109) on this embodiment of the sensing hardware (100) allows for functions, such as an alarm, to function without a remote device. One example of how this embodiment of the sensing hardware ( 100) uses the data points generated by user movement can be to alert the user if and when the sensing hardware ( 100) detects a lack of movement over a period of time. The microcontroller (109) software may be defined to activate an alarm (1 16) if a specific condition is met by the received data points. For each sensing zone (104), a timer can be activated when a data point from said sensing zone (104) can be collected. The timer can be restarted upon the receiving of a subsequent data point from the same sensing zone (104). If a pre-set time interval expires after the microcontroller (109) collects a first data point from a sensing zone (104), the microcontroller ( 109) software will activate an alarm (1 16) to notify the user of the device that the sensing zone (104) has been inactive for longer than specified.

The alarm (1 16) device may produce an alert in the form of light, sound, scent, vibration, and/or visualization such as digital text or graphics. For example, if the microcontroller ( 109) can be connected to a remote device via USB, a graphic user interface on the computer will activate its digital alarm. Furthermore, if the sensing hardware (100) includes a wireless transmitter, the alarm (1 16) device may be external to the device or computer; the alarm may be another device, such as a battery-powered bracelet, configured with the sensing hardware's wireless transmitter that vibrates upon alarm activation. The event of an alarm can be stored to the removable storage device. 2 !

This alert notifies the user to move their body, and by prompting the user to move, will avoid prolonged pressure to ulcer-prone body parts, thereby preventing pressure ulcers. Upon receiving a subsequent data point from the same sensing zone (104), the alarm (1 16) will cease and the timer for this zone will restart. If the sensing hardware ( 100) includes an On/Off switch, the alarm (1 16) will cease upon turning the switch to the off position. Turning the switch back to the On position will restart the system and wait for a first data point.

An alternative embodiment of the invention can include a different scale of sensing hardware (100). In this case, the sensing hardware (100) can include a single sensing zone (104). A plurality of the single sensing zone (104) sensing hardware (100) devices may be used for one patient. These single sensing zone ( 104) devices may be arranged under a user where the zone corresponds to a specific area of the body. For example, there may be a separate sensing hardware (100) device for the head, shoulders, back, buttocks, sacrum, knees, heels, etc.

It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the above-described embodiments, without departing from the broad general scope of the present disclosure. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

CLAIMS:

1 . A patient movement monitoring system comprising:

a wirelesss transmitter; and

2. The patient movement monitoring system of claim 1 wherein the system further comprises a receiving device that receives at least one data packet from the wireless transmitter and uploads that data packet to an internet database.

3. A patient movement monitoring system comprising:

a wirelesss transmitter;

a remote receiving device;

4. The patient movement monitoring system of claim 3 wherein the two or more energy harvesting devices are piezoelectric energy harvesting devices.

5. The patient movement monitoring system of claim 1 or claim 3 wherein the sensing hardware comprises one or more planar members.

6. The patient movement monitoring system of claim 5 wherein the sensing hardware comprises an inner layer encased within two pliable layers.

7. The patient movement monitoring system of claim 2 or claim 3 wherein the receiving device runs sensing software, said sensing software being used to alert a person on conditions, events, or status derived from the generated data.

8. The patient movement monitoring system of claim 1 or claim 4 wherein the sensing hardware comprises a plurality of sensing zones, each zone comprising a plurality of piezoelectric energy harvesting devices.

9. Sensing hardware for use in a patient movement monitoring system, the sensing hardware comprising:

a planar member suitable for placement relative to a patient;

a wirelesss transmitter; and

10. The sensing hardware of claim 9 wherein the two or more energy harvesting devices are piezoelectric energy harvesting devices.

1 1. The sensing hardware of claim 10 wherein the planar member is relatively thin compared to its lateral and longitudinal extent and is relatively conformable to the configuration of other structures.

12. The sensing hardware of claim 1 1 wherein the planar member is embedded within a cushion or other structure of a mattress or chair.

13. The sensing hardware of claim 9 wherein the wireless transmitter is at least partially powered by the respective currents.

14. The sensing hardware of claim 13 further comprising an auxiliary power source for the wireless transmitter and/or other componentry of the sensing hardware.

15. The sensing hardware of claim 14 wherein the other componentry includes a microcontroller that processes the data packet before transmission by the wireless transmitter.