DATA CAPTURE DEVICE

The present invention relates generally to the capture of data and particularly, although not exclusively, to the capture of data relevant to the healing process of an individual following an injury or illness.

Data relevant to the healing process has many uses, including monitoring and assessment of the recovery itself and the behaviour of the injured individual during the recovery period.

The present invention is based on the two proven principles that a) patients exhibit better healing profiles when they are a part of a study (i.e. they are being watched), and; b) that improved telemetry and informatics of planar movements, and other sensory/physiological inputs, are critical to the optimisation of patient rehabilitation profiles.

Some aspects and embodiments of the present invention therefore seek to communications enable orthopaedic devices to create data streams that can be the segue to improved care and rehabilitation times.

The healing process following an injury is influenced by many factors, some of which result from actions taken by the individual and can positively or negatively affect recovery. For example, an individual may be provided with a set of instructions following the injury which, if followed, will promote healing and speed the recovery process; likewise, if the instructions are not followed the recovery process may be prolonged.

Some aspects and embodiments of the present invention have as their goal the delivery of a unique offering to help healthcare providers better manage their patients pre- and post-surgery for a range of conditions with particular emphasis on the musculoskeletal sector.

Some aspects and embodiments relate to the delivery of a "virtual clinic" solution for musculoskeletal care pathways. This includes the communications enablement of joint (knee, ankle, hip), and bone related devices, thus helping to provide improvements in operational procedure and excellence in rehabilitation through granularity of easily accessible, well ordered data, that is not currently available in the orthopaedic medical profession.

Some aspects and embodiments of the present invention have an overall vision of a step-change in the quality of healthcare for patients requiring orthopaedic treatment and rehabilitation using improved informatics.

Continual remote monitoring of the patient enables care pathways to be modified and personalised, leading to improved success in outcomes. Biomedical devices are at the very start of a journey of data- orientated technology enablement, necessary to collect, analyse and feedback the data from multiple sensors contained within the device. Providing clinicians with real-time data on patient activities and healing profiles will enable better care pathways for current treatments. Creating this unparalleled richness of data, is only achievable via technology driven data capture, and will give clinicians access to reliable and accurate data sources not previously available to them.

Some aspects and embodiments of the present invention have the following aims and objectives:

Objective I : To reduce the overall requirement for visits to hospital and the use of expensive procedures such as x-rays by transmitting data from the sensors in the device, through a network of data handling procedures and to present the new informatics to the clinician. This requires the comms enablement of the device.

Objective 2: To define data storage and presentation processes and to design and deliver a user interface that is intuitive for use by the clinician (and patient in certain sanitised modes). This data will enable the more productive treatment and analysis of the patient's condition without the requirement for a hospital visit.

Objective 3: To provide the clinician with the processing tools and algorithmic applications to be able to a) be alerted if a device is not optimally configured, b) be able to sort patients in order of priority based on how their treatment is progressing, and; c) to make analytics-driven suggestions of how a clinician might prioritise their workflow, based on patient status and demand for intervention.

The application of informatics is critical to the delivery of any of these objectives.

The present invention may find utility in the field of bone fractures. When a bone has an outside force exerted upon it, like a blow or a fall, there is potential that it cannot withstand the amount of force and it breaks. That loss of integrity results in a fracture.

The natural process of healing a fracture starts immediately, when the injured bone and surrounding tissues bleed (forming a fracture hematoma); however, the whole recovery process may take up to 18 months. In a normal recovery in adults the strength of the healing bone is usually 80% of normal by 3 months after the injury.

Several factors may help or hinder the bone healing process. For example, normally after a tibial fracture the individual will be instructed to rest and elevate the leg for the first two weeks. Weight- bearing stress on bone, after the bone has healed sufficiently to bear the weight, builds bone strength and is therefore encouraged. Any form of nicotine hinders the process of bone healing and adequate nutrition (including calcium intake) will help the bone healing process.

Clinical assessment of fracture healing currently relies upon (normally monthly) physical examination and X-ray radiographs, both of which require the individual to attend a surgery. In addition, X-ray radiographs have been shown to be, at best, qualitative, and at worst erroneous; fracture manipulation has also been demonstrated to be inaccurate. Furthermore, the infrequency of examination means that problems in the healing process are often not picked up early, and establishing the healing end-point (allowing discharge of the individual) is delayed.

The present invention seeks to address the problems with known systems for monitoring and assessing patient recovery.

According to an aspect of the present invention there is provide a data capture device for monitoring an individual, comprising a sensor for measuring one or more parameters relevant to an injury/illness, and means for transmitting data therefrom.

A further aspect provides a remote communication enabled orthopaedic device. Some embodiments form part of, or relate to, an external bone fixation system.

The device can take measurements relevant to the healing/recovery process and can transmit the data (raw or partially/fully processed) onwards to allow further actions to be performed, such as for processing, analysis by a physician, information purposes (such as for the individual), alert purposes (for example if the individual is taking an action likely to lead to additional problems), predicting healing end- point or monitoring compliance with instructions.

The parameters may include one or more of: inclination; orientation; acceleration. This could be used, for example, to measure activity (such as steps taken) or monitoring if a limb is being elevated.

The parameters may include one or more of: inter-fragmentary movement; deformation; strain. For bone fracture monitoring there are several criteria which can be used to monitor the healing process and predict/determine the healing end-point.

The parameters may include one or more of: temperature; oxygen level; glucose level; nicotine presence; blood pressure; heart rate. This could be useful, for example, to monitor activity or compliance with a non-smoking instruction.

In some embodiments the sensor/s used include an accelerometer and/or an inertial measurement unit (IMU), for example an IMU that comprises an accelerometer, gyroscope and a magnetometer to provide a precise position in space.

The device may be provided with onboard power and/or onboard power generation means (such as a piezoelectric transducer for example).

Data may be transmitted from the data capture device continuously. Alternatively or additionally, data may be transmitted periodically from the data capture device. The transmission of data from the device may be automatic or controlled/triggered by user input. In an example, data can be transmitted from the data capture device using a short-range wireless communications protocol such as: ANT, ANT+, Bluetooth, Bluetooth Low Energy, Cellular, IEEE 802.15.4, IEEE 802.22, ISAI OOa, Infrared, ISM Band, Near-Field Communications, RFID, 6L0WPAN, Ultra-Wideband, Wi-Fi, Wireless HART, WirelessHD, WirelessUSB, ZigBee, Z-Wave.

Data may be transmittable to a proxy for onward transmission. For example, the data may be transmitted from the device to an item of user equipment such as a mobile phone, laptop computer or tablet. From there, some or all of the data may be available to the individual and may be onwardly transmitted to, for example, a web server. This then allows the data to be accessed, for example, by a clinician to analyse the recovery of the individual. Because the present invention allows for data to be transmitted regularly, the clinician can be kept informed about their patient on a regular basis, for example with hourly, daily, weekly or monthly updates. The clinician may also have the ability to request and view real-time data.

Data may be storable locally on the device. This could be useful, for example, if data transfer is not possible.

Data may be encrypted for transmission from the device. In an example, the proxy can transmit the received data in encrypted form and may not have access to a decryption key. The data may be decrypted when accessed by, for example, a clinician as noted above.

The device may comprise means for providing feedback to the individual. For example if, based on the data, it is determined that the individual is not elevating their leg during the initial period after a break, then the device (or a separate communication device) could indicate this to the individual to encourage them to comply. Feedback data may be generated by the user equipment and/or web service for transmission to the device. For example, raw data representing an individual's movements can be used to provide tailored feedback for the individual to enable quicker recovery. In an example, raw data can processed to derive movement related data of the individual such as elevation levels for a broken leg and/or number of steps walked over a predetermined period of time and so on. This can be mapped to a profile or set of profiles representing the individual's injury to determine a measure of compliance or non-compliance with a preferred or optimum regimen for recovery. In the case of non-compliance for example, the individual can be alerted and provided with feedback indicating suggested remedial action. In an example, such feedback data may be generated by the device.

The present invention also provides a system for monitoring the healing process of an afflicted individual, comprising a data capture device which can measure one or more parameters and means for transmitting data from the device. The system may further comprise processing means for analysing the data. Processing of data may be conducted partially or completely by the device, or remotely by a proxy device or by a web-based analytics engine.

The system may comprise means for providing feedback to the individual. For example haptic, visual or audible feedback provided by the device itself or by an associated device.

The locally collected, remotely communicated telemetry data can be used, for example to provide real time information.

The present invention also provides a bone fixation monitoring system comprising a device or system as described herein.

The present invention may provide a quick, simple, repeatable, but quantifiable assessment of fracture healing progression/end-point that does not rely on the use of X-rays or on un-measured manipulation.

Some aspects and embodiments of the present invention relate to spinal treatment and rehabilitation. Currently, the only method of using a spinal device or 'frame' to improve the position of a spine is periodically to physically assess the patient, and usually this will result in a reactive course of action that is defined by the movements picked up by sensors in the frame-based device. This is problematic for several reasons:

1. The clinician is only able to see how the patient's spine is responding to the latest set of adjustments periodically. Usually, the length of this period is defined by a compromise between the availability of appointment slots and the practical frequency with which the patient and the clinician is able to coordinate (and be available to travel to) an appointment.

2. It can be particularly challenging for a patient to travel to and attend hospital when suffering from a spinal condition. The process usually involves a good deal of support from family members and/or carers, putting a great deal of pressure on the supporting networks.

3. More visits to hospitals for routine appointments create issues and a burden on the hospital infrastructure itself (parking constraints etc).

Some aspects and embodiments of the present invention provide an innovative product and/or service, comprising a communications-enabled spinal device for clinical use.

A further aspect of the present invention provides an ankle fracture elevation monitoring device.

A fracture is a partial or complete break in a bone. In the ankle, fractures involve the far or distal ends of the tibia, the fibula, or both bones. The tibia is the shinbone and is located on the inner, or medial, side of the leg. The fibula is located on the outer, or lateral, side of the leg. The distal ends of the tibia and fibula bones are also known as the medial and lateral malleoli, respectively. Some ankle fractures can be treated without surgery. These are usually injuries where one bone is minimally displaced. Such fractures can be treated simply with a period of immobilisation. Once the initial swelling improves over the first several days, either a cast or a fracture boot can be applied to the ankle to properly protect and immobilise it. Casts or fracture boots are also used following surgery for more complicated or serious fractures.

Elevating an ankle injury, for example, 12 to 18 inches above the heart, significantly reduces the blood pressure to the injured tissues and decreases the amount of swelling after injury.

In some embodiments the device is configured to monitor the angle of elevation and to provide an alarm, alert or other warning. The alarm, alert or warning may be provided locally (e.g. by the device itself) and/or remotely (e.g. communicated to medical staff). In some embodiments, for example, the device is equipped with a visual and/or audible warning means to alert the patient if their ankle has been lowered below a predetermined threshold value (which may be adjustable).

In some embodiments the device can also inform the patient that they are complying with the require elevation instruction e.g. a green light.

In some embodiments the device is provided with means for capturing and/or analysing data.

Some embodiments relate to a simple "dumb" monitoring device with a local effect e.g. just visible by the patient and attending medical staff. However, in some embodiments the device is provided with onboard communication means for transmitting information. For example the device may be provided with a protocol for sending data over a Bluetooth link.

In some embodiments the device is provided with: means for measuring the angle of elevation of the patient's leg; a microprocessor; an onboard communications module; alert means activatable if the angle of elevation is below a threshold value.

In some embodiments the data from the sensor/s is process to determined degree seconds, including the amount of time the ankle has been above a certain level. In some embodiments the data is used to provide an elevation curve i.e. a representation of the level of elevation over time and/or an indication of how long the ankle has been elevated at or above the threshold versus a target. This could, for example, inform a physician how long the patient's ankle has been in a compliant/non-compliant position.

Data captured by the device may be stored locally and/or transmitted therefrom.

The device may be configured so that it can be strapped or otherwise secured onto an ankle and/or onto a cast/boot. In some embodiments the device can be bonded or otherwise secured into a cast; the device may be shaped/configured and/or include structures for facilitating this.

Further aspects of the present invention provide devices configured and/or adapted to monitor other predetermined threshold values indicative of compliance with medically beneficial instructions, such as the angle of elevation of a limb, or refraining from and/or performing a particular movement or activity. The device can be configured to provide an alert during periods of non-compliance. Data capture and/or storage and/or communications functionality may be provided.

A further aspect provides a device for measuring movements across a joint (connections made by bones).

Types of joints which may be monitored by the present invention include: i) simple joints (two articulation surfaces e.g. shoulder joint, hip joint); ii) compound joints (three or more articulation surfaces e.g. radiocarpal joint); iii) complex joints (two or more articulation surfaces and an articular disc or meniscus e.g. knee joint).

Joints that may be monitored by the present invention include: hand joints; elbow joints; wrist joints; axillary articulations; sternoclavicular joints; vertebral articulations; temporomandibular joints; sacroiliac joints; hip joints; knee joints; and articulations of feet.

In some embodiments the present invention is an external device, and may, for example, be provided in the form of a brace, support, strap or the like with onboard sensors provided thereon or thereby. In other embodiments one or more sensors could be (temporarily or permanently) located internally.

In one embodiment one or more sensors (such as an accelerometer or IMU) are provided at least on either side of a joint (in use) so that information such as the angle across a joint can be measured. Additionally, in some embodiments one or more sensors (such as an accelerometer or IMU) are provided at or in the region of the joint.

In some embodiments the device is configured to measure strain and/or torsional forces across a joint (for example the rotation of an arm).

Data captured by the device may be stored locally and/or transmitted therefrom.

The present invention also provides a method for monitoring compliance with medical instructions comprising the steps of: defining one or more instructions determining one or more measurements correlatalbe with the or each instruction; and providing a device to monitor the one or more measurements and from which measurement data can be accessed. Through enabling the digital instrumentation of orthopaedic devices and associated supports and strappings outside of a clinical environment, healthcare professionals, for the first time will be able to monitor how a patient is conforming to their specific pathway to rehabilitation and make decisions based on real time calculations. This can not only lead to optimal recovery times but reduce the burden on the healthcare provider from both a cost and time perspective with face to face meetings limited to necessary appointments.

The use of an associated app allows all recorded data to be easily accessible for both the patient and clinician at all times via a phone, tablet or web application. This visualisation of data allows for informed choices and recommendations to be made based on real time information.

The treatment of orthopaedic patients, especially outside of a controlled clinical environment has not seen any real fundamental change for several decades. Through the analysis of recorded data, clinicians and patients now have the opportunity to remotely monitor pathways to recovery, freeing up valuable time for surgeons whilst better supporting the patient's individual needs.

With the general practice of appointments being scheduled face to face at regular intervals, huge time and resource pressures have been placed on the healthcare system to support this direct contact. The VCD platform allows for collected data to be analysed at increased intervals ensuring contact is only required when absolutely necessary.

Further aspects and embodiments of the present invention relates to or include miniaturisation and battery optimisation, multi comms interface capability, and software/hardware data connectivity. The result being the ability to monitor both pre and post operatively to ensure the best possible outcomes for a patient and healthcare provider are being met.

Different aspects and embodiments of the invention may be used separately or together.

Further particular and preferred aspects of the present invention are set out in the accompanying independent and dependent claims. Features of the dependent claims may be combined with the features of the independent claims as appropriate, and in combination other than those explicitly set out in the claims.

The present invention will now be more particularly described, with reference to the accompanying drawings.

All orientational terms, such as upper, lower, radially and axially, are used in relation to the drawings and should not be interpreted as limiting on the invention or its connection to a closure. Example embodiments are described in sufficient detail to enable those of ordinary skill in the art to embody and implement the systems and processes herein described. It is important to understand that embodiments can be provided in many alternate forms and should not be construed as limited to the examples set forth herein.

Accordingly, while embodiments can be modified in various ways and take on various alternative forms, specific embodiments thereof are shown in the drawings and described in detail below as examples. There is no intent to limit to the particular forms disclosed and as well as individual embodiments the invention is intended to cover combinations of those embodiments as well. On the contrary, all modifications, equivalents, and alternatives falling within the scope of the appended claims should be included. Elements of the example embodiments are consistently denoted by the same reference numerals throughout the drawings and detailed description where appropriate.

The terminology used herein is not intended to limit the scope. The articles "a," "an," and "the" are singular in that they have a single referent; however, the use of the singular form in the present document should not preclude the presence of more than one referent. In other words, elements referred to in the singular can number one or more, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises," "comprising," "includes," and/or "including," when used herein, specify the presence of stated features, items, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, items, steps, operations, elements, components, and/or groups thereof.

Unless otherwise defined, all terms (including technical and scientific terms) used herein are to be interpreted as is customary in the art. It will be further understood that terms in common usage should also be interpreted as is customary in the relevant art and not in an idealised or overly formal sense unless expressly so defined herein.

Referring first to Figure I there is shown an external bone fixator 10 connected either side of a bone fracture (in this embodiment a tibial fracture) by fixator pins 20. A monitoring device 30 is attached to the fixator, effectively providing an instrumented fixator.

Figure 2 shows a section of the device 30 and shows it connected around the fixator 10. The fixator 10 is provided with a strain gauge 12 to measure loading in the X and Y planes and also torsion.

The device 30 has an orientation sensor 32, which in this embodiment is a 3-xais accelerometer and a gyroscope to measure orientation and inclination of the leg. It can also measure spikes in G-force and therefore can act as a pedometer.

The device also has: a temperature sensor 34 for measuring fracture site temperature; and a strain gauge amplifier 36 for conditioning the raw signal from the strain gauge.

The device is further provided with a central processing unit (CPU) 38 for processing raw data. The device is also provided with a communications module 40, which in this embodiment is a Bluetooth Low Energy and/or Wi-fi module.

The device may be operable to push or pull data. This may be useful when someone wants to analyse the progress of a patient since they could request data to be transmitted from the bone fixation system at will in a pull mode, but also if the system detects the onset of a complication then the system could contact someone, such as a clinician, in a push mode.

Figure 3 illustrates that the instrumented fixator of Figures I and 2 collects data and transfers it to a secure web-based server 50. Data may be proxied through a smartphone/tablet 42 or bespoke device 44 in the case of Bluetooth, or sent directly over broadband in the case of Wi-fi. The hop from the home to the Cloud could be over broadband, the mobile data network or even via satellite 46.

In Figure 4 the secure Cloud-based server 50 is illustrated. A data receiver 52 receives raw data from the device, decrypts it and stores it in a database 54. An analytics engine 56 runs various algorithms to assist the clinician and/or patient in interpreting the data. The data may be (selectively) available to the clinician and/or patient via dedicated portals 60, 62. As data accumulates it is possible to profile an individual and predict when the healing end-point (at least in terms of clinical discharge) is reached. This profile can include criteria such as whether the individual is a smoker (which will delay healing). The portals 60, 62 may be app-based and may display, for example, a predicted healed-by date, data illustrating progress towards a target (e.g. activity). The present invention may also provide a "buddy" system in which other individuals in a similar situation are paired with the individual to compare healing progress.

In the example of a tibial fracture, the strain gauge will monitor the strain placed on the fixator. Initially, there should be little or no strain on the fixator if the individual is resting. When the individual first starts to place weight on the leg the fixator will be very high because the bone cannot take the load. Over time, as the bone heals it can take more of the load.

Figure 5 shows three healing profiles based on strain measurements. The ideal/normal healing profile is shown by the solid line and illustrates the expected low, increasing then decreasing load on the fixator. The dotted line shows the profile of a patient whose break is not healing. The dashed line shows the profile of a patient who is not complying with instructions (such as not elevating, or not exercising). The present invention may determine/provide a standard healing profile and then compare the individual's profile against it, with alerts/warnings possible if the profile moves away from an expected profile by more than a predetermined amount. This embodiment is based on automatically and remotely gathering information from the device installed on the patient's leg. The information that is gathered is transferred securely to a centralised repository through which clinicians can examine the information to follow the progress of the patient.

To achieve the above, a microcontroller and a number of sensors are fitted to the fixator device to measure: loading of the fixator device, which can be used to correlate how the fracture is healing; orientation and movement of the patient's leg to determine if the patient is adhering to the clinician's instructions to aid their recovery; and temperature of the patient.

This information is then automatically transmitted over a communications medium to a centralised repository where it is stored in a database for review. The raw data can then be processed to combine all the information into visual representations that the clinical team can use to understand how the fracture is healing.

If the collected data shows the fracture is healing as expected then no further action would be required at that point. If the data revealed there were anomalies or progress was not in line with what is expected, then the clinical team can call the patient in for a consultation.

The benefits of this are that patients are not required to make routine visits to see the clinician if the fracture is healing as expected. Conversely, problems with the healing process can be identified early and addressed immediately without waiting for the next scheduled appointment before they are discovered.

Figures 6 to 19 show various different designs for instrumented external fixators formed in accordance with the present invention. Although in these embodiments the devices are shown connected to a fixator, in other embodiments, for example as illustrated in Figures 20 and 21. In these embodiments the device 1510, 1610 is not attached to a fixator and may, for example be associated with an affected area of the body using a support, sleeve, strap 1515, 1615 or the like.

Figures 22 and 23 show an ankle extension monitoring device 1750. The device 1750 comprises a top shell component 1755 and a base 1760. As shown in Figure 24 the top shell 1755 houses the working components of the device, which includes an accelerometer, a microprocessor and a Bluetooth communications module. In addition the top shell has a warning light 1765.

The base 1760 covers the open side of the shell 1755 and also includes two extension tongues 1770, 1775 at either end thereof. In use the tongues can either be fixed into a plaster cast at the time of casting (so that they serve to anchor the device into the cast) or they could serve as attachment points for a strap or the like for securing the device in the ankle region (e.g. over a cast or boot). In use the indicator light 1765 become illuminated in use if the microprocessor determines that the device (and hence a patient's ankle) is elevated (as determined by the accelerometer) below a predetermined value.

I I The light will cease to be illuminated if the elevation level is returned above the predetermined value. Information from the accelerometer and microprocessor is communicated using the communications module.

Figure 25 shows a trans joint monitoring device 1880. The device 1880 comprises a shoulder brace 1885 (other embodiments are adapted for other types of joints), for example made from a flexible material such as neoprene. The device includes a first sensor 1890 (such as an accelerometer or IMU) positioned on one side of the shoulder joint and a second sensor 1892 (such as an accelerometer or IMU) positioned on the other side of the joint. In this embodiment a third sensor 1894 (such as an accelerometer or IMU) is provided between the first and second joints. The three sensors are in this embodiment located in a triangular configuration.

The sensors are linked (with a wired or wireless connection) to a processor for receiving data therefrom. The processor may be provided as part of the brace. Data from the sensors can be used to measure angles across the joint and, for example, could be used to measure torsional forces; in this case rotation of the arm could therefore be measured.

Injuries/illnesses with which the present invention might be used include fractures, sprains, ligament and muscle damage. Fractures with which the present invention might be used include tibia, wrist, spinal, ankle, elbow and shoulder.

Although illustrative embodiments of the invention have been disclosed in detail herein, with reference to the accompanying drawings, it is understood that the invention is not limited to the precise embodiments shown and that various changes and modifications can be effected therein by one skilled in the art without departing from the scope of the invention as defined by the appended claims and their equivalents.