The invention relates to orthopaedic devices, such as orthoses or braces, which are configured to provide a heating and/or cooling effect to a subject being treated. The invention extends to the use of such devices in methods of treatment, for example treating damaged limbs, muscles or joints of either humans or animals.

An orthosis (plural: orthoses) or brace is an externally applied device used to modify the structural and functional characteristics of the neuromuscular and skeletal system. For example, an orthosis or brace can be used to control, guide, limit and/ or immobilise an extremity, joint or body segment, assist or restrict movement in a given direction, reduce weight bearing forces, or aid rehabilitation from fractures after the removal or a cast. Orthoses exist for treating both upper limbs and lower limbs. Certain braces or orthoses are configured to provide a heating and/ or cooling effect to a body part of a subject using the Peltier effect, which is the presence of heating or cooling at an electrified junction of two different conductors. When current is made to flow through the junction of the two conductors, heat may be generated or removed. In some cases, a fan is provided which increases the rate of cooling. By providing the body part with a repeating cycle of heating and cooling, therapy is provided.

However, problems associated with known braces are that they tend to be bulky and therefore rigid, due to the provision of the fan during the cooling phase. They are therefore uncomfortable to wear for extended periods of time. In addition, problems with known braces are that it is not easily possible to create intense heating/ cooling on the treatment site. Hence, there is a need for an improved brace for use in treating orthopaedic conditions. According to a first aspect of the invention, there is provided an orthopaedic device comprising a thermoelectric module capable of generating heat and providing a cooling effect to a region of a subject fitted with the device, and a detachable fan, characterised that the device is configured to cause the thermoelectric module to generate heat when the fan is not attached to the thermoelectric module, and the device is configured to cause the thermoelectric module to provide a cooling effect when the fan is attached to the thermoelectric module. Advantageously, the orthopaedic device of the invention comprises a detachable fan, which is not permanently attached to the thermoelectric module, and so the overall weight of the device, while it generates heat (i.e. heating mode), is reduced, which thereby improves comfort and wearability. Attachment of the fan causes the device to automatically and quickly switch to cooling mode. In addition, power

consumption of the device is significantly improved as the fan is not used during the heating stage, and is only used during the cooling stage.

The device may be used to treat any orthopaedic condition. For example, the device may be used to treat common injuries, such as bruises (contusions), muscle pulls (strains), sprains, fractures, arthritis, Sciatica and tendonitis. The device can also be used to stop internal bleeding in a tissue, relieve pain, reduce muscle spasms, cool deep tissues, lower metabolic activity, reduce swelling and inflammation. It can also be used to improve flexibility of tendons and ligaments, reduce muscle spasms, alleviate pain, elevate blood flow and boost metabolism.

The device maybe used to treat orthopaedic conditions in any mammal, for example livestock, pets, or maybe used in other veterinary applications. Most preferably, however, the subject is a human being. The device maybe an orthopaedic brace or orthosis.

In one preferred embodiment, when the fan is not attached to the thermoelectric module, the device is configured to adopt a voltage polarity which causes the thermoelectric module to generate heat and, when the fan is attached to the thermoelectric module, the device is configured to automatically reverse the voltage polarity and cause the thermoelectric module to provide a cooling effect.

Advantageously, therefore, the device automatically switches from heating mode to cooling mode by simply attaching the fan to the thermoelectric module.

Preferably, the device comprises attachment means for securing the thermoelectric module adjacent the region of the subject being treated. The attachment means preferably comprises at least one strap, which may comprise Velcro (RTM) or the like. The thermoelectric module preferably comprises a Peltier device, which will be known to the skilled person. Preferably, the thermoelectric module comprises first and second mutually contacting electrical conductors, which, when current flows therethrough, are configured to generate or remove heat, preferably at a contacting junction thereof. Preferably, the conductors comprise ceramic. Preferably, one or both conductors are encased by textile material of the device. Advantageously, when the device is in a "heating" mode, the subject's skin is protected by the textile material and so will not be burned. Preferably, the first conductor is substantially malleable, and can be manipulated to bend and conform to the shape of the region being treated. Preferably, the second conductor is substantially rigid, and cannot be bent. Preferably, the first and second conductors are secured together, for example with a heat sink compound, which allows greater electrical conductivity between them. In one embodiment, the specification of the thermoelectric module may be as follows: l.iA, 5.3V, 2.9W, with a maximum temperature range of about 200K.

Preferably, the device comprises a thermally conductive member, which is permanently disposed adjacent the thermoelectric module, and preferably adjacent one or both electrical conductors thereof. The thermally conductive member may comprise a thermally conductive pad, which covers the thermoelectric module. Advantageously, the pad provides a highly efficient thermal connection between the thermoelectric module and the fan, when it is attached. In one embodiment, the specification of the fan may be 12V, 0.78A; or 15 V, 1.1A.

Preferably, the device comprises securing means for attaching the fan to the thermoelectric module, and preferably the thermally conductive member

therebetween. Preferably, the securing means comprises engagement means disposed on the fan, which engagement means is configured to mutually engage with receiving means disposed at least adjacent the thermoelectric module. In a preferred embodiment, the thermoelectric module is housed within an opening which receives the fan. Preferably, the engagement means is disposed on a peripheral edge of the fan and the receiving means is disposed on a peripheral edge of the opening.

Preferably, the engagement means comprises one or more spaced-apart clips, and the receiving means comprises one or more spaced-apart lugs, or vice versa. Preferably, at least a region of the fan is electrically conducting (e.g. metallic) and the inside of the opening is electrically conducting (e.g. metallic), such that a complete electrical circuit is created when the fan is attached to the thermoelectric module. Attachment of the fan therefore automatically reverses the voltage polarity, such that the thermoelectric module provides a cooling effect. Preferably, the fan comprises a heatsink attached thereto, which improves heat transfer when in the heating or cooling mode. Preferably, the heatsink is disposed between the fan and the thermoelectric module, when the fan is attached. Preferably, the heatsink is electrically conducting, and it creates the electrical circuit when the fan is attached.

In one embodiment, the device comprises a control unit for controlling the temperature of the thermoelectric module. Preferably, the control unit uses wireless technology, for example Bluetooth. For example, the device may comprise the use of a mobile phone or tablet App, which is configured to control the voltage and therefore temperature of the thermoelectric module. The device preferably comprises a power source, such as a battery, for powering the thermoelectric module and fan.

In another embodiment, the control unit is preferably distal from the thermoelectric module and connected thereto by a cable. The control unit preferably comprises one or more of a battery, an LCD display, a voltage control, a timer, a polarity switch, temperature sensor and a menu button.

Preferably, the control unit comprises a programmable logic controller (PIC), which provides pulse width modulation (PWM) for controlling the thermoelectric module, and preferably the LCD display, voltage control, timer, polarity switch, temperature sensor and/or menu button. Advantageously, use of pulse width modulation to control the duty cycle of the thermoelectric module means that less voltage is used, which therefore makes the device more efficient without affecting the output. By increasing/decreasing the duty cycle using the control unit, the device is configured to control the voltage which controls the temperature produced by the thermoelectric module.

Preferably, the device comprises a switch which is configured to reverse the voltage polarity when the fan is attached to the thermoelectric module. This switch can be referred to as a voltage override. Preferably, the device comprises temperature sensing means configured to make real-time measurements of the temperature created by the thermoelectric module at the treatment site.

According to a second aspect, there is provided a method of treating, preventing or ameliorating an orthopaedic condition in a subject, the method comprising attaching the device according to the first aspect to a subject in need of such treatment. The method preferably comprises attaching the device to the subject in a

configuration wherein the fan is not attached to the thermoelectric module.

Accordingly, the method comprises causing the thermoelectric module to heat the subject's treatment region. Once the selected heating period ends, the method preferably comprises manually connecting the fan to the thermoelectric module. Preferably, the method comprises creating an electrical circuit between the fan or heatsink and the thermoelectric module to automatically reverse the polarity of the voltage. Preferably, the method comprises causes the thermoelectric module to switch from heating to cooling. The method may comprise removing the fan, which automatically results in switching the thermoelectric module from cooling to heating. In another

embodiment, the method may comprise manually overriding the voltage reversal by actuating a voltage polarity override switch, which causes the thermoelectric module to switch back to heating for heat treatment while the fan is still attached to the thermoelectric module.

A "subject" maybe a vertebrate, mammal, or domestic animal. Hence, the device according to the invention may be used to treat any mammal, for example livestock (e.g. a horse), pets, or maybe used in other veterinary applications.

Most preferably, however, the subject is a human being.

All of the features described herein (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, maybe combined with any of the above aspects in any combination, except combinations where at least some of such features and/ or steps are mutually exclusive. For a better understanding of the invention, and to show how embodiments of the same may be carried into effect, reference will now be made, by way of example, to the accompanying Figures, in which:-

Figure la-id is an exploded view of a first embodiment of an orthopaedic device according to the invention fitted to a patient's wrist/hand;

Figure 2 is a plan view of a control unit of the orthopaedic device shown in Figure l; Figure 3 is a circuit diagram for the motor fan attachment;

Figure 4 is a circuit diagram for the relay;

Figure 5 is a circuit diagram for the apparatus system;

Figure 6 is an exploded view of a second embodiment of the orthopaedic device of the invention;

Figures 7-10 are various perspective views of the embodiment shown in Figure 6; Figure 11 is a partially exploded view of the second embodiment;

Figure 12 is a side view of the second embodiment; and

Figure 13 is a plan view of the second embodiment.

Referring to Figure 1, there is shown a first embodiment of an orthopaedic device or brace 2, which harnesses the Peltier effect for heating and cooling a subject's body part to treat an orthopaedic condition. For example, the brace 2 can be used to treat common injuries such as bruises (contusions), muscle pulls (strains), sprains, fractures, arthritis, Sciatica and tendonitis. Using cold treatment with gentle compression after suffering an injury helps to stop internal bleeding in the tissue, relieve pain, reduce muscle spasms, cool deep tissues, lower metabolic activity, reduce swelling and inflammation. The application of superficial heat to one's body can improve the flexibility of tendons and ligaments, reduce muscle spasms, alleviate pain, elevate blood flow and boost metabolism. By way of example only, the brace 3 is shown attached to a patient's wrist/hand 4, but it could equally be designed such that it could be worn on another part of the body, such as the back, knee, elbow or shoulder etc. Although the shape and general configuration of the brace 2 would need to change to fit a certain body part, the overall mechanism of action involving the Peltier heating/cooling effect would not.

As shown in Figure la, the wrist support part of the brace 2 neatly fits over the patient's wrist allowing the figures and thumbs to extend therefrom. The patient inserts his hand into the wrist support and then tightly seals it thereon using a Velcro (RTM) strap 6. The brace 2 includes a circular fan attachment opening 12 which is disposed adjacent the section of the subject's wrist to be treated. Inside the opening 12, there is provided a Peltier device 8, which consists of two contacting, electrically conductive ceramic strips which are sown into the material io of the brace 2.

Accordingly, when the Peltier device 8 is in its "heating" mode, as will described later, the patient's skin is protected by the material io and so will not be burned. One of the two conductive ceramic strips is substantially malleable so that it arcs around the patient's wrist (or other body part) being treated. The Velcro (RTM) strap 6 enables the malleable strip to be comfortably tightened around the patient's wrist. The second conductive strip of the Peltier device 8 is more rigid than the first, and extends from the patient's wrist to the palm of the hand. The two ceramic strips cross at the wrist and are secured together, for example, with a heat sink compound which allows greater electrical conductivity between them. The Peltier device 8 is itself glued into place in the material io, and cannot move during use. The specification of the Peltier device 8 is as follows: l.iA, 5.3V, 2.9W, with a maximum temperature range of about 200K.

Referring now to Figure lb, the brace 2 includes a circular thermally conductive pad 22 (HS200 PC-99, 0.06mm with a thermal conductivity of 1.5W/1T1.K), which is permanently secured to the upper surface of the Peltier device 8. The diameter of the pad 22 is the same as that of the opening 12, i.e. 60mm. The pad 22 provides an efficient thermal connection between the Peltier device 8 and a fan 14 and its associated heatsink 16, which are shown in Figures id and ic, respectively. The fan 14 and heatsink 16 are permanently secured together using thermally conductive glue. The fan 14 runs off 12V, 0.78A, and has a diameter of about 60mm.

As shown in Figure ic, the outer peripheral edge of the heatsink 16 includes four spaced-apart metallic clips 18, which are designed to mutually engage with four correspondingly spaced apart lugs 20 located on the inside edge of the fan attachment opening 12. Thus, the fan 14 and heatsink 16 snap-fit on to the attachment opening 12 housing the Peltier device 8 and associated thermally conductive pad. The heatsink 16 is metallic and the inside of the fan attachment opening 12 is provided with a metal (e.g. copper) conductive layer so that, when the fan 14 and heatsink 16 are secured in position in opening 12, a complete electrical circuit is automatically created. Attachment of the fan 14 in the opening 12 creates a voltage drop, which is identified by the circuitry of the brace 2, which itself causes a change in voltage polarity. Referring to Figure 2, there is shown a control unit 30 of the orthopaedic brace 2. The control unit 30 includes a re-chargeable lithium ion battery 32, an LCD display 34, and various control buttons, including a voltage control 36, a timer 38, a polarity switch 40, temperature sensor and a menu button 42. The battery 32 supplies a maximum of 12V, 2000mAh. The control unit 30 includes a chip which uses a programmable logic controller (PIC), which provides pulse width modulation (PWM) for controlling the Peltier device 8. The LCD display 34 shows relevant temperature, voltage and times to the user. The timer 38 allows the user to select from a given list of times as to how long the brace 2 heats/cools before turning off or providing an alarm signal.

The battery 32 in the control unit 30 can be connected via a cable 44 to a connection port 24, which is disposed adjacent the fan attachment opening 12 of the brace 2, as shown in Figure la. The control unit 30 is placed inside the patient's pocket, and cable 44 can be fed from the control unit 30 in a pocket along the sleeve and down to the user's wrist where it connects to the connection port 24. Thus, the user can easily separate the battery 32 from the wrist support of the device 2. The cable 44 can then be placed into a charging unit connected to a wall socket for charging the battery 32.

Referring to Figure 3, there is shown an embodiment of a circuit of the motor fan attachment 46. Referring to Figure 4, there is shown an embodiment of a circuit of a relay 48. The relay 48 provides additional security to ensure that the voltage polarity switches over, although the PIC will automatically achieve this. Referring to Figure 5, there is shown an embodiment of a system circuit 50. The circuitry shown in

Figures 3-5 uses pulse width modulation to control the duty cycle so that less voltage is used, which therefore makes the device 2 much more efficient without affecting the output. By increasing/ decreasing the duty cycle using buttons 36 on the control unit 30, the device can control the voltage which controls the temperature produced by the Peltier device 8. The brace 2 includes a temperature sensing diode 52 adjacent the fan attachment 12 for making real-time measurements of the temperature created by the Peltier device.

Use of the orthopaedic brace will now be described with reference to the Figures. The user first dons the brace 2, for example on the wrist, so that the Peltier device 8 is placed adjacent the area to be treated. As mentioned above, the brace 2 could be - Si - designed to fit adjacent any body part, such as the knee or the shoulder etc. When first donned, the brace 2 does not have the fan 14 and heatsink 16 attached thereto; these are unattached and can be kept separately, for example in the user's pocket. The user then connects the control unit 30 to the brace 2 by attaching the cable 44 to the connection port 24, and sets the desired temperature and timer for heating by the appropriate buttons 38, 40, 42 on the control unit 30. For example, a suitable heating temperature is 40-45°C and the time is from 5-30 minutes. The LCD 34 displays the relevant information. When the settings are confirmed to be correct, the user then presses the "OK" button 40, which starts heating via the Peltier device 8 as a "heating mode". The voltage is between o-5.3Volts.

Once the selected heating mode ends, the user then manually connects the fan 14 and heatsink 16 to the fan attachment opening 12. This is achieved by causing the four spaced-apart metallic clips 18 to mutually engage with the four correspondingly spaced apart lugs 20 located on the peripheral edge of the fan attachment opening 12. Insodoing, the metallic heatsink 16 contacts with the metal conductive layer inside the fan attachment opening 12 and creates an electrical circuit, which results in an immediate drop in voltage. This voltage drop is identified by the circuitry, and automatically reverses the polarity of the voltage, as shown in the circuit diagram in Figure 3. This polarity reversal causes the Peltier device 8 to shift from the "heating mode" to a "cooling mode", as shown in Figure 5. Thus, attachment of the fan 14 quickly and automatically results in switching from heating to cooling.

The Peltier device 8, thermally conductive pad 22, and heatsink 16 and fan 14 are mutually arranged such that they are thermally connected with each other. Hence, the treatment area is now cooled, with the fan increasing cooling rate. When sufficient cooling has taken place, removing the fan 14 automatically results in switching the Peltier device 8 from cooling to heating mode. However, although the fan's 14 primary purpose is to be attached to the brace 2 when the user wishes to conduct cold treatment, the user can manually override the voltage reversal by pressing the polarity switch 40, which causes the Peltier device 8 to switch back to heating mode for heat treatment while the fan 14 and heatsink 16 is still attached to the fan attachment opening 12. Accordingly, with the Peltier deice 8 back in heating mode, the fan 14 and heatsink 16 effectively extract the cold allowing for a deeper heating sensation, i.e. with the fan 14 on, the brace 2 can become even hotter. Referring now to Figures 6-13, there is shown a second embodiment of the orthopaedic device 60 in exploded view. In this embodiment, the device 60 has a planar heat transfer element 62 which is attached to the material 10 (not shown) of the device 60, and by which the element 62 is arranged, in use, to contact the skin of the wearer. The heat transfer element 62 is secured to a strap plate 64 by means of mutually engaging lugs (not shown) disposed on the plate 64 and spaced apart peripheral slots 66 provided in the edge of the heat transfer element 62. The strap plate 64 is itself secured to a base plate 68 by means of two spaced apart spring clips 70, which clip onto lugs 72 disposed on one edge of the base plate 68.

The base plate 68 has a first aperture 74 in which the fan 14 is disposed, and a second aperture 76 in which the Peltier device 14 is disposed. The strap plate 64 also has an aperture 78 which aligns with the second aperture 76 in the base plate 68, and by which the heating or cooling effect from the Peltier device 14 is transferred onto the heat transfer element 62, and eventually to the subject wearing the device 60.

Finally, the device 60 has a large heatsink 16 which contacts and clips onto the fan 14 and Peltier device 8.

Unlike in the first embodiment 2, the second embodiment 60 does not have a cable 44 which attaches to the user control panel 30. Instead, this embodiment harnesses Bluetooth and a smart phone or tablet App by which the user controls the device 60. The App enables control of a temperature controller so that the user selects what temperature they wish in real time. The App also controls program duration, i.e. the duration of time the user wishes the device to remain at that temperature. In addition, the App provides a precise temperature reading, i.e. gives a real-time, accurate temperature reading.

Advantages of both embodiments of the orthopaedic device 2 reside in the fact that the fan 14 and heatsink 16 are not permanently attached to the brace (i.e. material 10), which reduces the overall weight while it is in initial heating mode, and improves wearability. Attachment of the fan 14 causes the brace 2 to automatically switch to cooling mode without the need to press any buttons on the control panel 30. In some embodiments, it may be desired to switch back to heating mode with the fan 14 in position, which enables deeper heating of the treatment area to enhance therapy.