WO2020070038A1

WO2020070038A1 - Medical system with sensors on a strap or harness

Info

Publication number: WO2020070038A1
Application number: PCT/EP2019/076359
Authority: WO
Inventors: Mark Freeman
Original assignee: Virtualclinic.Direct Limited
Priority date: 2017-10-03
Filing date: 2019-09-30
Publication date: 2020-04-09
Also published as: GB2579684A; GB201716123D0; GB201904592D0; WO2019069072A1; GB2568810A

Abstract

A data capture device for monitoring an individual is provided. The device comprises a support, strap or the like and a plurality of sensors provided on or by the support, strap or the like for measuring one or more parameters.

Description

MEDICAL SYSTEM WITH SENSORS ON A STRAP OR HARNESS

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 and/or for collecting data relevant to the performance of an individual.

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. Data relevant to the performance of an individual also has many uses, including for training purposes.

Some aspects of the present invention are 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. Other aspects and embodiments seek to assist in the improvement of performance characteristics (which may or may not be linked to recovery from an injury).

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 musculo-skeletal sector.

Some aspects and embodiments relate to the delivery of a“virtual clinic” solution for musculo-skeletal 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.

I Continual and/or periodic remote monitoring of the patient enables care pathways may 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.

The present invention may, for example, 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 feree 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. Weightbearing 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.

In one aspect the present invention provides a data capture device for monitoring an individual, comprising a support, strap or the like and a plurality of sensors provided on or by the support, strap or the line for measuring one or more parameters.

The parameters may include one or more of: inclination; orientation; acceleration.

The parameters may include one or more of: inter-fragmentary movement; deformation; strain. The parameters may include one or more of: temperature; oxygen level; nicotine presence; blood pressure; heart rate.

The device may comprise means for transmitting data.

Data may be transmitted using a short-range wireless communications protocol.

Data may be transmitted using a near field communications protocol.

Data may be transmittable to a proxy for onward transmission.

The device may comprise means for providing feedback to the individual.

The device may comprise an accelerometer or an IMU.

The present invention also provides a system for monitoring and/or optimising the healing process of an afflicted individual, comprising a data capture device as claimed in any preceding claim 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 means may be provided locally and/or remotely.

The present invention provides a musculo-skeletal monitoring system comprising a device or system as described herein.

The present invention provides an orthopaedic monitoring system comprising or including a device or system as described herein.

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 as described herein to monitor the one or more measurements and from which measurement data can be accessed.

Data may be transmitted from the device for determination of correlation/s. The present invention also provides a trans-joint monitoring device comprising an orthopaedic strapping, support or the like and a plurality of sensors, the sensors can intercommunicate.

The sensors may be 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.

Some aspects and embodiments of the invention relate to the ability to monitor multiple orthopaedic plains of movements that a patient would undertake throughout their rehabilitation from both surgery and trauma. The monitoring could be part of the pre-operative care pathway as well as the postoperative recovery plan.

The device, may, for example, work by allowing the patient to be monitored remote to a clinical environment whether this be a hospital or private care facility such as a physiotherapist. This is done by fitting multiple sensors (more than I ) to an orthopaedic strapping or support worn by the patient. The sensors may have the ability to talk to each other which in turn enables multiple plains of movement to be monitored.

Unlike standard sensors which only measure a single plain of movement by having multiple sensors many different plains of movement can be monitored such as rotation, which is not currently possible.

Each sensor may contain the following technology: sensors each of which communicate over BLE. Each of the sensors may have a 3-axis accelerometer (currently an ADXL345). This could be changed to other similar devices or even an IMU chip such as the MPU6050.

When the patient is initially fitted with the strapping or support the surgeon could commission the sensors in the correct position before turning on. This will ensure that the correct angles are measured during rehabilitation from this point.

The collected data may then be sent via Bluetooth from the sensor to a phone then the cloud before being shown on both patient and clinician portals. The data shown on both portals may be different and specifically designed for the requirements of the surgeon and patient.

The movements that can be monitored by devices/ systems formed in accordance with present invention may include (US nomenclature in parentheses): Grouped as opposing movements:

Ankle

1. Plantar flexion (Flexion), Dorsiflexion (Extension)

2. Supination, Pronation

Knee

I . Flexion, Extension

Hip

1. Flexion, Extension

2.Abduction, Adduction

3. Internal (Medial) Rotation, External (Lateral) Rotation.

Shoulder

1. Forward flexion, Extension.

2. Abduction, Adduction

3. Internal(medial) rotation, External (lateral) rotation

4. Glenohumeral vs scapulo-thoracic motion.

5. Scapular protraction/ retraction

Elbow

1. Flexion, Extension

2. Forearm supination and pronation

Wrist

I Flexion, Extension

2. Pronation, Supination

3. Radial and Ulnar deviation

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.

Some embodiments are based on automatically and remotely gathering information from the device installed on the patient’s leg. The information that is gathered may be 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 may be form part of the device.

This information may then be 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.

In some embodiments, if the collected data shows the injury 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.

According to an aspect of the present invention there is provide a data capture device for monitoring an individual, comprising a plurality of sensors 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.

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 endpoint 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. In another embodiment the device could provide feedback to an individual if they are approaching or exceeding predetermined threshold movement restrictions. 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.

Some aspects and embodiments of 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 orthopaedic device of the type described/define herein for clinical use.

A further aspect of the present invention provides an orthopaedic monitoring device comprising two or more sensors that are mutually spaced and can intercommunicate. The sensors may be provided on a or a strap, support, brace or the like.

In some embodiments the device can also inform the patient that they are complying with required instructions 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/inclination/orientation/rotation of a patient’s limb; a microprocessor; an onboard communications module; alert means activatable if the angle of elevation/inclination 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 limb has been in and/or out of a required range of elevation/inclination. 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 a patient’s limb has been in a compliant/non-compliant position.

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

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.

An aspect of the present invention 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.

Figure I shows a trans joint monitoring device 10. The device 10 comprises a shoulder brace 15 (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 20 (such as an accelerometer or IMU) positioned on one side of the shoulder joint and a second sensor 25 (such as an accelerometer or IMU) positioned on the other side of the joint. In this embodiment a third sensor 30 (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.

Figure 2 shows a trans joint monitoring device I 10. The device I 10 comprises a shoulder brace I 15 (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 120 (such as an accelerometer or IMU) positioned on one side of the shoulder joint and a second sensor 125 (such as an accelerometer or IMU) positioned on the other side of the joint.

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.

In this embodiment the invention relates to the ability to monitor multiple orthopaedic plains of movements that a patient would undertake throughout their rehabilitation from both surgery and trauma. The monitoring could be part of the pre-operative care pathway as well as the post-operative recovery plan.

The device works by allowing the patient to be monitored remote to a clinical environment whether this be a hospital or private care facility such as a physiotherapist. This is done by fitting multiple sensors (more than I ) to an orthopaedic strapping or support worn by the patient. The sensors will have the ability to talk to each other which in turn enables multiple plains of movement to be monitored.

Each sensor contains the following technology: sensors each of which communicate over BLE. Each of the sensors has a 3-axis accelerometer (currently an ADXL345). This can be changed to other similar devices or even an IMU chip such as the MPU6050.

When the patient is initially fitted with the strapping or support the surgeon will commission the sensors in the correct position before turning on. This will ensure that the correct angles are measured during rehabilitation from this point.

The collected data is then sent via Bluetooth from the sensor to a phone then the cloud before being shown on both patient and clinician portals. The data shown on both portals may be different and specifically designed for the requirements of the surgeon and patient.

Figures 3 to 5 illustrate examples of how the sensors may ‘speak’ to each other for different orthopaedic injuries.

The movements that can be monitored include (US nomenclature in parentheses):

Grouped as opposing movements:

Ankle

1. Plantar flexion (Flexion), Dorsiflexion (Extension)

2. Supination, Pronation

Knee

I . Flexion, Extension

Hip

1. Flexion, Extension

2.Abduction, Adduction

3. Internal (Medial) Rotation, External (Lateral) Rotation.

Shoulder 1. Forward flexion, Extension.

2. Abduction, Adduction

3. Internal(medial) rotation, External (lateral) rotation

4. Glenohumeral vs scapulo-thoracic motion.

5. Scapular protraction/ retraction

Elbow

1. Flexion, Extension

2. Forearm supination and pronation

Wrist

I Flexion, Extension

2. Pronation, Supination

3. Radial and Ulnar deviation

Figures 6 to 10 illustrate an example of a Patient Software Application. The images are a representation of what the patient and/or clinician could see. There is a direct correlation between the data acquired by the sensors to what the clinician and patient see.

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.

Claims

1. A data capture device for monitoring an individual, comprising a support, strap or the like and a plurality of sensors provided on or by the support, strap or the like for measuring one or more parameters.

2. A device as claimed in claim I , in which the parameters include one or more of: inclination; orientation; acceleration.

3. A device as claimed in claim I or claim 2, in which the parameters include one or more of: inter-fragmentary movement; deformation; strain.

4. A device as claimed in any preceding claim, in which the parameters include one or more of: temperature; oxygen level; nicotine presence; blood pressure; heart rate.

5. A device as claimed in any preceding claim, in which the device comprises means for transmitting data.

6. A device as claimed in claim 5, in which data is transmitted using a short-range wireless communications protocol.

7. A device as claimed in claim 5 or claim 6, in which data is transmitted using a near field communications protocol.

8. A device as claimed in any of claims 5 to 7, in which data is transmittable to a proxy for onward transmission.

9. A device according to any preceding claim, comprising means for providing feedback to the individual.

10. A device according to any preceding claim, in which the device comprises an accelerometer or an IMU.

1 1. A device as claimed in any preceding claim, in which the sensors can intercommunicate.

12. A system for monitoring and/or optimising the healing process of an afflicted individual, comprising a data capture device as claimed in any preceding claim which can measure one or more parameters, and means for transmitting data from the device.

13. A system as claimed in claim 12, further comprising processing means for analysing the data.

14. A system as claimed in claim 13, in which processing means is provided locally and/or remotely.

15. A musculo-skeletal monitoring system comprising a device or system as claimed in any of claims I to 1 .

16. An orthopaedic monitoring system comprising or including a device or system as claimed in any preceding claim.

17. 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 according to any of claims I to I I to monitor the one or more measurements and from which measurement data can be accessed.

18. A method as claimed in claim 17, in which data is transmitted from the device for determination of correlation/s.

19. A trans-joint monitoring device comprising an orthopaedic strapping, support or the like and a plurality of sensors, in which the sensors can intercommunicate.

20. A device as claimed in claim 20, in which the device comprises means for transmitting data.