TECHNICAL FIELD

[0001] The present invention relates to an adjustable positioning device and, more particularly, to an adjustable limb positioning device for use in orthopaedic medical applications.

BACKGROUND

[0002] Functionality of limbs and joints can be assessed using a number of measurements such as strength, range of motion, flexibility, nerve sensation and graphic depiction of any abnormalities. Obtaining and assessing such measurements can be costly and time consuming and often inconvenient or painful for a patient with an abnormal or deformed limb or joint.

[0003] For lower limbs and feet, range of motion is often used to determine the functionality or possible deformity of the ankle or knee joint or the foot itself. Most joints allow for a certain amount of movement in one or more directions. Medical professionals and physical therapists will often use a goniometer to measure range of motion of a joint. The device has two arms with a hinge in the middle. This device is used to measure the degree to which the joint can be straightened, bent, or rotated. However, the goniometer device is designed for angular measurement only, and does not provide for any additional analysis or measurement of associated parameters. The use of the goniometer and the measurement itself may also provide a degree of pain for a patient with an abnormal or injured joint. The data record is also a manual process and requires additional steps to record the output.

[0004] PCT/US2017/034033 discloses a device for measuring range of motion of an ankle providing for angular measurement of the range of motion of a patient's ankle, and includes a foot rest having a base, a pair of sidewalls and an inclined upper surface. A foot retainer releasably receives the patient's foot. A mounting plate is slidably mounted to one of the pair of sidewalls. The lower end of an elongated rod is rotatably mounted to the mounting plate. An inclinometer is secured to the elongated rod. A retaining bar is secured to the elongated rod, adjacent its upper end. The retaining bar is adapted for positioning adjacent a calf muscle of the patient when the patient's foot is received in the foot retainer. However, the measurement of the range of motion of the ankle is a manual measurement and there is a limitation to the degree of adjustment that can be used to measure an injured or deformed ankle. There is also no capacity to incorporate the measurement result into a more complex data set of foot and lower limb measurements, in the case of a medical device, for example.

[0005] US 5,588,444 discloses a modular ROM measurement system. A transmitter has a horizontal support surface on which are mounted a magnetic north seeking means and a levelling means for measurement in a transverse plane. Releasably attached to the horizontal support surface is at least one additional modular component selected from the group of components consisting of an inclinometer for determining the degree of inclination of the horizontal support surface from the horizontal, a headband, a stabiliser plate, one or more elastic bands, one or more vertical mode plates selected from the group of plates consisting of a thorax plate and an extremity plate, and one or more soft level adjusting means. Each of the modular components from the above group of components may be releasably and temporarily interengaged with one another and the horizontal support surface of the transmitter, so that a plurality of separate instrument configurations may each be temporarily assembled for performing a specific ROM measurement function and then be disassembled for compact storage or for reassembly into the sake or different instrument configurations. While this device has a degree of flexibility of measurement, ultimately, the measurements are manual measurements and there is a limitation to the degree of adjustment that can be used to measure an injured or deformed ankle. There is also no capacity to incorporate the measurement result into a more complex data set of foot and lower limb measurements, in the case of a medical device, for example. [0006] US 5,163,228 discloses a system for measuring an inputting range of motion data to a computer that comprises a goniometer for measuring range of motion and for producing a range of motion signal from those measurements. A plurality of switches are carried by the goniometer for producing control signals. An interface device receives the range of motion signal and digitises that signal to produce a range of motion data. The interface device also receives the control signals which are used to control the input of the range of motion data to the computer. This device is limited to measurements that can be taken by a goniometer and there is a limitation to the degree of adjustment that can be used to measure an injured or deformed ankle.

[0007] Some devices are designed to analyse measurements of the foot and ankle during movement. US 8,375,784 discloses a method and system for measuring energy expenditure of individuals by measuring force from a plurality of foot-borne force sensitive resistors and calculating incline from a foot-borne tri-axial accelerometer. US 9,307,932 discloses a system and a method for assessment of walking and miming gait in humans. The method is preferably based on the fusion of a portable device featuring inertial sensors and several new dedicated signal processing algorithms: the detection of specific temporal events and parameters, optimised fusion and de-drifted integration of inertial signals, automatic and online virtual alignment of sensors module, 3D foot kinematics estimation, a kinematic model for automatic online heel and toe position estimation, and finally the extraction of relevant and clinically meaning-full outcome parameters. At least one wireless inertial module is attached to foot, the system provides common spatio-temporal parameters (gait cycle time, stride length, and stride velocity), being able to work in an unconstrained condition such as during turning or running. It furthermore may provide original parameters for each gait cycle, both temporal (load, foot-flat and push duration) and spatial (foot clearance and turning angle), and their intercycles variability. The system and method, according to the invention, allows the assessment of various aspects of gait, including foot clearance, turns, gait initiation and termination, running, or gait variability. This system may be lightweight for wear and use, and suitable for any application requiring objective and quantitative evaluation of gait. However, such a device does not cater for a patient with limited or altered movement due to an injured or abnormal foot or for obtaining certain structural measurements associated with a foot or ankle.

[0008] US 9,259,172 discloses a method of providing feedback an orthopaedic alignment system coupled to display comprising tracking movement of a prosthetic component wherein a tracking system is coupled to the prosthetic component; transmitting tracking data to a computer wherein the computer is coupled to a display; displaying a needle point graphic on display wherein the computer is configured to receive the measurement data and wherein the needle point graphic is configured to move as the prosthetic component moves; and measuring a parameter with the tracking data wherein the computer is configured to calculate the parameter from the measurement data. Such a system is typically suited to an orthopaedic specialist or similar medical professional and has limitations in its application accordingly.

[0009] US 2018/0279919 Al discloses a neuromuscular, physiological, biomechanical, or musculoskeletal activity monitoring system for a subject. The system includes a wearable inertial measurement unit, including at least one accelerometer and/or at least one gyroscope. The system also includes a controller in communication with an output component. The controller is configured to: receive and process information from the inertial measurement unit representative of one or more physical actions performed by the subject; generate an inertial data set for the one or more physical actions based on the received and processed information; compare the generated inertial data set to reference data stored on computer-readable memory in communication with the controller; and cause the output component to provide feedback including predictive injury information. The predictive injury information is based, at least in part, on the comparison between the generated data set and the reference data. However, the capacity of a patient to perform the required physical action or movement could be limited and such a system is likely to require specialised medical knowledge, therefore limiting its application.

[0010] The prior art discloses devices, such as goniometers, that can measure single angular measurements of a joint or limb. However, these devices are not optimised to measure and analyse a complex biological model like a human foot and leg that can be abnormally positioned when injured and requires additional analysis. Existing devices for analysing joints and limbs and abnormalities thereof are complex, costly and often require highly specialised knowledge and skill to operate with limited application.

[0011] Any discussion of the prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of common general knowledge in the field.

SUMMARY

[0012] PROBLEMS TO BE SOLVED

[0013] It is an aim and objective of the present invention to provide a device to hold a complex biological model such as a joint or limb while measuring the dimensions thereof.

[0014] It is an aim and objective of the present invention to provide a device that can account for an injury or deformity while measuring the dimensions of a limb or joint.

[0015] It is an aim and objective of the present invention to provide an automatic, single- step data recording process.

[0016] It is an aim and objective of the present invention to optimally measure parameters such as range of motion in a joint or limb in an automatic or semi-automatic way for both the patient and the operator.

[0017] It is an aim and objective of the present invention to provide a device that is designed to hold a normal or injured limb or joint during measurement and also integrate with scanning software and/or mobile apps.

[0018] It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art or to provide a useful alternative. MEANS FOR SOLVING THE PROBLEM

[0019] According to a first aspect, the invention provides a device for positioning a limb at a defined angle, the device comprising: at least one base comprising a first elongate passage; a top frame, wherein a proximal end of the top frame is hingedly connected to the base; the top frame comprising at least one side portion, wherein the at least one side portion comprises a second elongate passage; at least one arm, wherein a proximal end of the at least one arm is slidably connected to the first elongate passage and wherein a distal end of the at least one arm is slidably connected to the second elongate passage; and a transparent support surface for supporting the limb, wherein the support surface is secured adjacent the top frame by at least one plate, wherein a position of the at least one arm is slidably adjusted along at least the first elongate passage to facilitate measuring range of motion or scanning of the limb at different angles of inclination.

[0020] Preferably, the position of the at least one arm is slidably adjusted along the first elongate passage and along the second elongate passage to facilitate measuring range of motion or scanning of the limb at different angles of inclination. The first elongate passage and second elongate passage preferably further comprise slots to receive the proximal end and the distal end of at least one arm respectively to adjust the angle of inclination of the limb positioned on the support surface. Preferably, the at least one arm further comprises a protrusion at the respective proximal and distal ends, such that the protrusions comprise an adjustment mechanism for adjusting the incline of the transparent support surface.

[0021] The adjustment mechanism preferably comprises tightening and loosening of the protrusions to allow the protrusions to move along the first and second elongate passages to support a position of the transparent support surface at various angles of inclination. Preferably, the angle of inclination of the limb can be adjusted from 45°to 85°.

[0022] The device preferably further comprises an electronic circuit board that is used to electronically detect the angle of inclination of the device, wherein the electronic circuit board is located at the proximal end of the top frame. The electronic circuit board preferably comprises a gyroscope sensor.

[0023] Preferably, the transparent support surface is a plate made from any transparent polymer material. The transparent plate is preferably made of acrylic. The device preferably further comprises a bottom frame, wherein the at least one base is attached to the bottom frame such that the bottom frame provides rigid support to the device. Preferably, the bottom frame further comprises a quick release mechanism such that the device can be mounted and dismounted from a measuring unit.

[0024] According to a second aspect, the invention provides a range of motion (ROM) measuring unit for use with the device according to the first aspect wherein the range of motion measuring unit can transmit measured data wirelessly to a software application on a computing or mobile device and can receive data transmitted from the device. The ROM measuring unit preferably comprises an upper surface and a lower surface, wherein the upper surface and the lower surface are connected by at least two independently driven legs, wherein the legs comprise linear actuators. The upper surface and the lower surface are preferably connected by at least six independently driven legs such that the ROM measuring unit moves with at least six degrees of freedom to establish an adequate position for patients with malformation in the limbs.

[0025] The ROM measuring unit preferably comprises an electronic circuit board and an electronic screen located in a case connected to the upper surface of the range of motion (ROM) measuring unit. The electronic circuit board is preferably connected to a sensor located on the upper surface and connected to the electronic circuit board, wherein the sensor is a gyroscope to indicate the position in which the centre of the upper surface is located. The range of motion (ROM) measuring unit preferably further comprises a joystick located in the centre of the electronic circuit board for directing the movement of the range of motion (ROM) measuring unit, wherein the joystick returns to a default position after use while the ROM unit remains in the position previously set by a operator. The joystick preferably moves in linear motion by default and can be changed to angular motion by a operator according to their requirements. In use, the limb is preferably rested on the transparent support surface while a operator performs a 3D scan of the limb wherein the limb is an arm, upper or lower leg, hand or foot.

[0026] In the context of the present invention, the words "comprise", ""comprising"" and the like are to be construed in their inclusive, as opposed to their exclusive, sense, that is in the sense of ""including, but not limited to"".

[0027] The invention is to be interpreted with reference to at least one of the technical problems described or affiliated with the background art. The present aims to solve or ameliorate at least one of the technical problems. This may result in one or more advantageous effects as defined by this specification and describe in detail with reference to the preferred embodiments of the present invention.

BRIEF DESCRIPTION OF THE FIGURES

[0028] Fig. la is a perspective view of a preferred embodiment of the device according to the invention;

[0029] Fig. lb is a perspective view of a preferred embodiment of the bases, frames and arms of the device of Fig. 1;

[0030] Fig. 2 is a front view of the preferred embodiment of Fig. 1, showing the top frame hingedly connected to the base, along with the battery, electronic circuit board, lithium battery and power button;

[0031] Fig. 3a is a side view of the preferred embodiment of Fig. 1, showing the protusions located at the proximal and distal end of one arm respectively slidably adjusted to the distal end of the respective slots contained in the first and second elongate passage;

[0032] Fig. 3b is a side view of the preferred embodiment of Fig. 1, showing the activation of the quick release mechanism on the bottom frame; [0033] Fig. 4 is a perspective view of the preferred embodiment of Fig. 1 illustrating the various angles of inclination of the device in use and also when stored away after use;

[0034] Fig. 5 is a perspective side view of the preferred embodiment of Fig. 1 in use when engaged with an ROM measuring unit showing a foot being held on the transparent plate for measurement of range of motion (ROM) or 3D scanning;

[0035] Fig. 6a and Fig. 6b are perspective view of the ROM measuring unit of Fig. 5 showing the upper surface of the ROM measuring being located at different levels of vertical adjustment and horizontal orientation;

[0036] Fig. 7a and Fig. 7b are left and right-side views of the ROM measuring unit of Fig. 5 and the electronic screen;

[0037] Fig. 8 is a top perspective view of the ROM measuring unit of Fig. 5 with the electronic screen;

[0038] Fig. 9 is a side view of the ROM measuring unit of Fig. 5 showing the electronic screen, the sensor, the electronic circuit board, the power button and programming button;

[0039] Fig. 10 is a cut-away view of the DT-ROM control showing the lithium battery, the joystick (with electronic circuit board) and power button.

DESCRIPTION OF THE INVENTION

[0040] Preferred embodiments of the invention will now be described with reference to the accompanying drawings and non-limiting examples.

[0041] As shown in Fig. la, the footplate 1 is a device that consists of two bases 2 and 3, a top frame 4 and a bottom frame 5 and two arms 6 and 7 that serve as supports. In a preferred embodiment, all of these components are made of 6061 anodized aluminium.

The bases 2 and 3 preferably comprise an L-shaped support having a hole 8 at one end to attach to the top frame 4. The bases 2 and 3 also preferably comprise elongate slots 9 and

10 in the central portion to provide a rail that the arms 6 and 7 connect to and move along to support the top frame 4 and help the rotational movement of the device 1.

[0042] The top frame 4 is attached to both bases 2 and 3 (left and right) forming a hingetype joint, allowing a rotational movement from 0 to 90°, as shown in Fig. 4. A clear acrylic sheet 11 is attached to the top frame 4 at the bottom of the frame by about 5 plates 12 that are screwed to the top frame 4. In a preferred embodiment, the clear acrylic sheet

11 typically measures about 20mm x 40mm, although other dimensions can be used as required. In a particularly preferred embodiment, the arms 6 and 7 are generally approximately 240 mm long and are connected by knobs 13 to the bases 2 and 3 and to the top frame 4. The top frame 4 comprises side portions 4a and 4b attached to the sides of the top frame 4, wherein side portions 4a and 4b comprise elongate slots 4a’ and 4b’, through which knobs 13 can move to adjust the level of inclination of the device 1. The operator can adjust the incline level of the device 1 by tightening or loosening the knobs 13.

[0043] As shown in Fig. lb, the bottom frame 5 is preferably in the form of an X, and can be screwed to the bases 2 and 3 and provides rigidity to the footplate 1. The bottom frame 5 preferably features a quick release mechanism 14, as shown in Fig. 3a and 3b. This mechanism 14 allows the operator to easily and quickly mount and unmount the device 1 to a Digital Technology Range of Motion (DT ROM) measuring unit 15. The footplate 1 is a device that helps a operator or practitioner to explore and scan the foot 16 at different degrees of inclination, from 45° to 85°. The operator or practitioner adjusts the footplate 1 to the desired inclination or that best suits the patient. The patient rests their foot 16 on the transparent acrylic sheet 11 while the operator or practitioner performs a foot scan. As shown in Fig. 5, the footplate 1 is mounted to the DT ROM 15 in a way such that the values of the range of movement of the ankle joint can be obtained while the patient rests their foot 16 on the acrylic sheet 11.

[0044] As shown in Fig. 2, the footplate 1 has an electronic circuit board 17 that allows the operator or practitioner to know the degree of inclination of the footplate 1. This electronic circuit board 17 is located at the bottom of the top frame 4, installed in a case 13a. It has a sensor (gyroscope) 18, and two connectors, one for the power button 19 and the other for the lithium battery 20, as well as a USB-C port to recharge the battery 19 and reprogram the electronic circuit board 17. The electronic circuit board 17 also comprises a LED to know the status of the device 1.

[0045] The footplate 1 connects via Bluetooth to the DT ROM 15 and sends digital data, such as the tilt angle of the device, and the battery status, to the DT ROM 15. The total weight of a preferred embodiment of the footplate device 1 is generally around 2.2 kg.

[0046] The DT ROM 15 preferably consists of two metal surfaces 21 and 22, an upper surface 21 and a lower surface 22. A particularly preferred embodiment comprises six independently driven legs 23. These legs 23 may be linear actuators with a torque of around 100 to 200 N, preferably about 15 ON, and a stroke length of around 25 to 100mm, preferably about 50mm.

[0047] A preferred embodiment of the DT ROM 15 moves with six degrees of freedom, as this allows the DT ROM measuring unit to have both linear and angular motion. Different degrees of freedom in other embodiments are also possible. These degrees of freedom help to establish a position for patients with malformations in the lower limbs such that a practitioner can measure the angle of the different movements of the ankle joint. The angles measured by the DT ROM 15 are shown on an electronic screen 24 positioned adjacent the DT ROM 15 while simultaneously being sent to a computer device application via Bluetooth.

[0048] The upper and lower surfaces 21 and 22 of the DT ROM 15 are shown as irregular hexagons, but can be any suitable shape. In a preferred embodiment, the lower surface 22 is made from stainless steel with a non-slip base, while the upper surface 21 is made from anodized 6061 aluminium. In particularly preferred embodiment, these surfaces 21 and 22 are connected by 6 linear actuators (legs) 23 with a torque of 150 N and a stroke length of 50mm. These actuators are mounted on universal joints 25 both at the bottom and top. As shown in Fig. 8 and Fig. 9, located at the back of the DT ROM is a case 26 supported by an anodized 6061 aluminium arm 27 with which the tilt angle of the case can be adjusted. The electronic intelligent screen 24 is installed together with an electronic circuit board 28 that controls the platform 29. The USB-C port is located in this electronic circuit board 28 to reprogram the electronic circuit board 28 and the 4" intelligent screen 24, a connector for the power button 30 and another for a button 31 that allows an operator to program either the electronic circuit board 28 or the electronic intelligent screen 24 and a connector for a sensor (gyroscope) 32. The sensor 32 is located in the lower part of the upper surface 21 mounted in a small housing and is connected by cables to the electronic circuit board 28 of the DT ROM 15 that is in the case 26. This sensor 32 will indicate to the system in which position the centre of the upper surface 21 is located.

[0049] As shown in Fig. 8, the electronic circuit board 28 can be powered by a battery 33 that is located in the centre of the lower surface 22. In a particularly preferred embodiment, the battery is a 11.1 v 5A battery, but other types of batteries may be used in other embodiments of the invention. The battery 33 may also provide power to the linear actuators 23. In one embodiment, the DT ROM 15 has a minimum height of about 160 mm and a maximum height of about 200 mm, can be tilted at an angle of up to 35° degrees and a centre distance travel of about 25mm. The total weight of the DT ROM in this embodiment is about 3.5 kg and the maximum speed of the lineal actuators is about 4 mm per second.

[0050] As shown in Fig. 10, the control 34 for the DT ROM 15 is ergonomically shaped for operator comfort. On the front of the control is a USB-C port for charging the lithium battery 35, that powers the electronic circuit board 36, and a power button 37. On the electronic circuit board 36, there are two connectors, one for the power button 37 and the other for connecting the battery 35. In a preferred embodiment, a manual control or joystick 38 may be located in the central part of the electronic circuit board 36 and can be manually handled to direct the movements of the DT ROM. Alternative means of electronic computer control may also be used to direct the DT ROM movements, such as arrow keys on a keyboard, a computer mouse or mouse pad, or an electronic pencil, for example.

[0051] As soon as the operator points the joystick 38 in any direction, the DT ROM 15 also moves in that same direction. The joystick 38 will returns to the default position following movement by the operator, but the DT ROM 15 remains in the position that the operator had previously moved to. Different positions of the DT ROM 15 are shown in Figs. 6a, 6b, 7a and 7b. As soon as the operator moves the joystick 38 to another direction, the DT ROM 15 follows the movement to that point. This is similar to the movement of a character in a video game, for example. The joystick 38 may have an internal button, that can be pressed by an operator to change from linear movement to angular movement. In a preferred embodiment, the DT ROM 15 moves linearly by default, but can be changed to angular movement by pressing the internal button according to what the operator requires.

[0052] The intelligent screen 24 may be a touch screen interface and will typically give an operator 3 main options; instructions, measurement and settings. In the instructions option, an operator may be able to access pre-recorded audio-visual or visual presentations to learn how the DT ROM 15 works and how to operate the DT ROM 15.

[0053] Settings such as Bluetooth connectivity, volume adjustment, brightness, about the version of the device, etc, may be found in the settings option on the intelligent screen 24.

[0054] In the measurement option on the intelligent screen 24, an operator can view the recorded movements of the ankle joint in a column for each foot (left and right). When the DT ROM 15 starts to move, as controlled by an operator moving the joystick 38, the measured values will appear in their respective moves. There is also an option to take the values again if there was an error when taking the measurements by double clicking on the button marked on the side of the foot on the intelligent screen 24. [0055] Table 1, below, discloses an example of data that will be measured by the DT ROM 15 and displayed on the intelligent screen 24. This data comprises different angles of the left and right ankle joint such as dorsiflexion, plantarflexion, supination, and pronation.

[0056] The intelligent screen 24 may have electronic menus or buttons to access calibration settings and/or control settings of the DT ROM 15 or to return to the previous menu. Accessing the calibration button or menu provides the operator with an option to calibrate the sensor 32 to establish a new reference zero. This new reference zero can then be saved, and new angles of different movements of the ankle joint can then be measured. It is possible to reset to zero by default, which will be a position where the DT ROM 15 is centred and level.

[0057] The control settings provide an operator with access to line control. An operator can use line control (linear movement) to move the DT ROM 15. That is, line control provides translational movement of the upper platform without any inclination of the upper platform.

[0058] The DT ROM 15 has the ability to connect to up to 7 electronic devices (tablets, computers, mobile phones etc) at the same time. These devices will be visible at the top of the screen, showing the battery charge represented by a circle.

[0059] In general, a DT ROM 15 will support a mass of up to 90 kg and can lift a mass of 45 kg.

[0060] One of the problems to be addressed in the development of the device of the present invention was achieving a large range of motion without resulting in a large, oversized device. Commercially available linear actuators that are capable of withstanding torque above 100N are very robust and large in size. However, the inventors of the present invention found that alternative, smaller motors of an acceptable size were not sufficiently strong enough to withstand the torque required to manoeuvre the linear actuators 23 of the DT ROM 15. [0061] This design challenge was addressed by optimising the design of the device by increasing the height i.e. increasing the length of the linear actuators 23. A suitable amount of torque was could surprisingly be achieved by increasing the length of the linear actuators 23 and using a suitably sized smaller linear motor that was commercially available on the market.

[0062] The electronic sensors 18 and 32 of the device 1 and DT ROM 15 are contained in a small case 13a and in the lower part of the upper surface 21 mounted in a small housing. Sensors 18 and 32 are used to measure the angle of inclination of the transparent acrylic sheet 11 on the device. The information from sensors 18 and 32 are transmitted wirelessly to the main electronic card that is located inside the intelligent screen 24 of the DT ROM 15. The sensor 32 is configured to receive the wirelessly transmitted data from the sensor 18 and is connected the intelligent screen 24 to display information generated by scanning of the limb supported on the transparent acrylic sheet 11. The data measurements can be transmitted wirelessly to an application on an electronic device such as an iPad or iPhone via Bluetooth or WiFi. Using the angle of inclination, the range of motion of an ankle joint can be determined when it is flexed forward, plantarflexion, backward dorsiflexion, sideways (depending on which foot), supination and pronation. Knowing the range of these four movements, the state of the joint can be determined, and a suitable product can be made for the operator.

[0063] Electronic circuit boards, also known as printed circuit boards (PCBs,) are essential to most modern electronic devices and are the foundation onto which all other electronic components are assembled. Semiconductors, connectors, resistors, diodes, capacitors and radio devices are mounted to and communicate through the PCB.

[0064] Approximately 90% of the 'PCB's manufactured today are rigid boards. Flexible PCBs comprise roughly 10% of the market, and these flexible PCBs allow the circuits to be bent and folded into shape without any break in the circuits. A small subset of these types of circuits are called rigid-flex circuits, where one part of the board is rigid - ideal for mounting and connecting components, and one or more parts are flexible, providing the advantages of flexible circuits listed above. [0065] Separate to this, another emerging PCB technology is printed electronics - typically simple, low-cost circuits that reduce electronic packaging expense to the level that electronic solutions can be developed to solve problems not previously considered.

[0066] Compared to traditional wired circuits, PCBs offer a number of advantages. Their small and lightweight design is appropriate for use in many modern devices, while their reliability and ease of maintenance suit them for integration in complex systems. Additionally, their low cost of production makes them a highly cost-effective option.

[0067] In particular, medical electronics have benefited from the introduction of PCBs. The electronics in computers, imaging systems, MRI machines and radiation equipment all continue to advance in technology from the electronic capability in PCBs.

[0068] Thin particular, thinner and smaller flexible and rigid-flex PCBs allow for the manufacture of more compact and lightweight medical devices. Rigid-flex PCBs are a particularly good solution when looking to decrease the size of complex medical devices, as they eliminate the need for flex cables and connectors that take up valuable space in more intricate systems.

[0069] The printed circuit boards used in the footplate and the DT ROM of the present invention can be powered by battery technology. In a particularly preferred embodiment, the electronic circuit board is powered by a rechargeable battery. A JST 2-pin connector 2mm pitch may be used. In a preferred embodiment, the electronic circuit board can be charged by a USB-C port.

[0070] Preferably, the limb is rested on the transparent plate while an operator performs a scan. The limb is preferably an arm, upper or lower leg, hand or foot.

[0071] The sole of the foot, or surface of any limb to be scanned, should be scanned without any interference. When placing a limb such as the sole of the foot on the base of the transparent acrylic plate 11, the DT ROM 15 has been designed such that the upper surface 21 and the lower surface 22 and the linear actuator legs 23 are not in a position to interfere with the scanning of the patient’s limbs or foot. This can be seen in Fig. 5.

[0072] Materials used to make medical devices must meet the engineering requirements of the end use application, but it must not pose any risk when in contact with the human body or the many types of chemicals, such as cleaners and disinfectants, that are often found in a clinical environment. Common metals used in medical devices include corrosion resistant grades of stainless steel, such as 316, 316L or 440. Most surgical tools are made from 440 stainless steel. Copper, titanium, cobalt, aluminium, magnesium and silver are also often used in medical device applications, due to stability, biosafety strength and corrosion resistance to varying degrees. The final choice of metal for a medical device will ultimately depend on the properties required of the device in the end use application.

[0073] In the present invention, 3D scanning is the process of analysing a limb to collect data on its shape. The collected data can then be used to construct digital 3D models and medical devices to support the scanned limb.

[0074] Bluetooth is being used in the medical space for wireless patient monitoring, for example. Bluetooth is also used in hospitals with secure data transfer between systems, in many cases allowing for data transfer to be automated as opposed to manually having to plug data storage into each device. The signal itself operates within the frequency of 2.4 to 2.485 GHz, which falls in the unlicensed scientific, industrial, and medical (ISM) category. According to the Bluetooth website, Bluetooth uses ""a spread spectrum, frequency hopping, full-duplex signal at a nominal rate of 1600 hops/sec"." This ""hopping"" keeps the Bluetooth signal connected between devices and prevents static from occurring due to competing signals.

[0075] Part of what has made Bluetooth so critical to modern equipment is the fact that it requires very little power to operate. The waves have a short broadcast range, and data streams are optimised to communicate as little as needed. Newer Bluetooth technology allows low power modes that can stay in contact with Bluetooth devices, even when 'there's no power at that instant.

[0076] Bluetooth is also starting to be integrated into patient monitoring devices. For example, electrocardiogram leads that didn't have wires or blood pressure cuffs that didn't need to be plugged into a monitor. In a sense, Bluetooth is beginning to allow medical devices to transition from clustered wired devices to "connected" internet of things devices. However, given the highly regulated and critical nature of medical technology, such devices that are developed to rely on Bluetooth or WiFi technology must be precisely and securely developed and programmed. In the present invention, wireless transmission of data via WiFi or Bluetooth can be used to send the range of motion data received by the sensors in the device to the electronic screen on the display screen unit and to a mobile or computer-based. Software application.

[0077] With this device, the normal foot can be positioned and locked in a neutral position for the purpose of digital scanning that can display the range of motion data on the display monitor and can migrate to the dedicated 3D scanning app seamlessly. For a structurally deformed foot and leg, this device can help position the foot and leg in a corrected position that can be tolerated by the patient at a maximum capacity of correction with a variable degree from the neutral position and can be locked in for the purpose of 3D scanning that can help to design a lower limb medical device precisely for that individual. This information also helps to build the baseline data for that individual, which can be used for rehabilitation and future treatment outcome evaluation purpose.

[0078] The creation of a device that does not exist on the market that helps to measure the range of motion of the ankle joint in a simpler, faster, more comfortable and semiautomatic way for both the patient and the operator. Taking into account the above, the advantage offered by this device is that the measurement of the range of motion can be established in a personalised reference, according to the patient. It shows the dimensions automatically on a screen found on the device, in addition to saving patient data and automatically sending them to an application via Bluetooth. [0079] The device 1 can be connected with 7 other devices (sensors) that would allow the range of movement of an entire limb to be measured. This data would be available to a user through the screen of an electronic computer device. In addition, the DT ROM 15 can act as a dynamic orthosis capable of helping the rehabilitation of the ankle joint.

[0080] The design of the device of the present invention and optimisation to the required application required a complex combination of technologies and skills. The development of the present invention also required a great deal of motivation and commitment to finding a solution to a long-term problem identified in the industry.

[0081] The development of the device of the present invention required an accumulated team experience of over 50 years in the footwear development industry and contributions from clinical, engineering, 3D design, electronics, biomechanics, and commercialisation perspective. This is a unique approach for such a complex invention in such a niche market. At the time of developing the present invention, existing manufacturers and clinical service providers were found to be using the conventional methods described in the forementioned Background section and the solution to the problems identified therein was not available at the time of the development of the device of the present invention.

[0082] Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms, in keeping with the broad principles and the spirit of the invention described herein.

[0083] The present invention and the described preferred embodiments specifically include at least one feature that is industrially applicable.