WO2022099385A1

WO2022099385A1 - Multi-layered instrumented mouthguard devices, and methods for manufacturing of instrumented mouthguard devices

Info

Publication number: WO2022099385A1
Application number: PCT/AU2021/051359
Authority: WO
Inventors: Mike Vegar; David Erikson; Yohan JAYASINGHE
Original assignee: HitIQ Limited
Priority date: 2020-11-16
Filing date: 2021-11-16
Publication date: 2022-05-19
Also published as: AU2021221564A1

Abstract

The present invention relates, in various embodiments, to multi-layered instrumented mouthguard devices, and methods for manufacturing of instrumented mouthguard devices. For example, this includes processes by which instrumented mouthguards, which include components such as accelerometer modules which enable monitoring of head movements of a mouthguard wearer, are manufactured with three or more material layers, and mouthguards formed via such methods.

Description

MULTI-LAYERED INSTRUMENTED MOUTHGUARD DEVICES, AND METHODS FOR MANUFACTURING OF INSTRUMENTED MOUTHGUARD DEVICES

FIELD OF THE INVENTION

[0001] The present invention relates, in various embodiments, to multi-layered instrumented mouthguard devices, and methods for manufacturing of instrumented mouthguard devices. For example, this includes processes by which instrumented mouthguards, which include components such as accelerometer modules which enable monitoring of head movements of a mouthguard wearer, are manufactured with three or more material layers, and mouthguards formed via such methods. While some embodiments will be described herein with particular reference to those applications, it will be appreciated that the invention is not limited to such a field of use, and is applicable in broader contexts.

BACKGROUND

[0002] Any discussion of the background art throughout the specification should in no way be considered as an admission that such art is widely known or forms part of common general knowledge in the field.

[0003] In recent years, there has been an increasing focus on the effects of concussions and other traumatic brain injuries on participants in contact sports, such as football/rugby disciplines, martial arts, and the like. In response, various parties have explored the possibility of embedding instrumentation into mouthguards, including the likes of accelerometers and gyroscopes, thereby to collect data representative of head movements. However, as these instrumented mouthguards transition from research instruments to broader usage (for example as consumer devices), there are challenges to be addressed in the context of device/component design and configuration.

SUMMARY OF THE INVENTION

[0004] 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. [0005] One embodiment provides an instrumented mouthguard device including:

[0006] a base layer, formed of deformable material, wherein the base layer is formed to encapsulate a subject’s mouthguard fitting region;

[0007] one or more printed circuit board components;

[0008] an outer layer which is sealed with respect to the base layer, such that the sealing of the outer layer with respect to the base layer protects the one or more printed circuit board components from ingress of fluids; and

[0009] at least one intermediate layer disposed between outer layer and the base layer, wherein the intermediate layer includes a region of protective material which is positioned to provide structural protection to at least a portion of the one or more printed circuit board components.

[0010] One embodiment provides a method of manufacturing an instrumented mouthguard, the method including:

[0011] forming a base layer using a detention mould;

[0012] mounting one or more printed circuit board components directly or indirectly to the base layer;

[0013] applying one or more coverings to the base layer at predefined locations, and subsequently forming a protective intermediate layer to the base layer, wherein the one or more coverings applied to the base layer prevent bonding of the intermediate layer to the base layer at the predefined locations;

[0014] trimming the intermediate layer such that the intermediate layer is positioned to provide structural protection to at least a portion of the one or more printed circuit board components, and leaves exposed sufficient surface area of the base layer as to allow bonding of a thermoformed outer layer; and

[0015] forming an outer layer over the base layer and intermediate layer. [0016] One embodiment provides a method of forming an instrumented mouthguard, the method including: (i) forming a base layer which mounts to a user’s mouthguard fitting region; (ii) mounting one or more PCB components directly or indirectly to the base layer; (iii) applying a stencil directly or indirectly over the one or more PCB components, such that the stencil defines a hollow dome over the one or more PCB components; (iv) thermoforming the outer layer over the stencil; (v) cutting through the outer layer and stencil thereby to form the window; and (vi) applying a transparent sealing substance thereby to seal the window.

[0017] Further example embodiments are disclosed in the description and claims below.

[0018] Reference throughout this specification to “one embodiment”, “some embodiments” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases “in one embodiment”, “in some embodiments” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

[0019] As used herein, unless otherwise specified the use of the ordinal adjectives "first", "second", "third", etc., to describe a common object, merely indicate that different instances of like objects are being referred to, and are not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, in ranking, or in any other manner.

[0020] In the claims below and the description herein, any one of the terms comprising, comprised of or which comprises is an open term that means including at least the elements/features that follow, but not excluding others. Thus, the term comprising, when used in the claims, should not be interpreted as being limitative to the means or elements or steps listed thereafter. For example, the scope of the expression a device comprising A and B should not be limited to devices consisting only of elements A and B. Any one of the terms including or which includes or that includes as used herein is also an open term that also means including at least the elements/features that follow the term, but not excluding others. Thus, including is synonymous with and means comprising. [0021] As used herein, the term “exemplary” is used in the sense of providing examples, as opposed to indicating quality. That is, an “exemplary embodiment” is an embodiment provided as an example, as opposed to necessarily being an embodiment of exemplary quality.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:

[0023] FIG. 1 illustrates a PCB component for an instrumented mouthguard according to one embodiment

[0024] FIG. 2 illustrates a mouthguard manufacture process according to one embodiment

[0025] FIG. 3A to 3C illustrate a process of mounting a PCB to a formed mouthguard base layer.

[0026] FIG. 4A to 4C show a base layer with PCB mounted.

[0027] FIG. 5A and FIG. 5B show locations at which a mounted PCB may be backfilled and otherwise prepared for subsequent operations.

[0028] FIG. 6A to FIG. 6I provide context to a process for applying an intermediate PCB protection layer.

[0029] FIG. 7A to FIG. 7D provide context to a process to a 3D scanning process.

[0030] FIG. 8A and 8B show a stencil which is applied to enable creation of a PCB component window following outer later thermoforming.

[0031] FIG. 9A to FIG. 9F provide context to a process for forming a PCB component window.

[0032] FIG. 18 shows a mouthguard with a formed PCB component window.

[0033] FIG. 11A and 11 B show example manufactured mouthguards. [0034] FIG. 12A to FIG 12D show contextual views of mouthguard and PCB according to one embodiment.

DETAILED DESCRIPTION

[0035] The present invention relates, in various embodiments, to multi-layered instrumented mouthguard devices, and methods for manufacturing of instrumented mouthguard devices. For example, this includes processes by which instrumented mouthguards, which include components such as accelerometer modules which enable monitoring of head movements of a mouthguard wearer, are manufactured with three or more material layers, and mouthguards formed via such methods.

[0036] According to one embodiment, an instrumented mouthguard device includes:

(i) A base layer, formed of resilient materials, which is formed to encapsulate a subject’s mouthguard fitting region. Preferably this base layer is custom formed for an individual subject’s mouthguard fitting region, for example based on a 3D scanning process (which is optionally used to form a custom mould, and/or guide a 3D forming/printing process).

(ii) One or more printed circuit board components. In the embodiments described in detail below, there is a single printed circuit board component comprising multiple component zones interconnected by flexible PCB strips. In other embodiments multiple PCBs may be used (for example PCBs interconnected by wires or the like).

(iii) An outer layer which is sealed to the base layer, such that the sealing of the outer layer to the base layer protects the one or more printed circuit board components from ingress of fluids. In a preferred embodiment, this outer layer is sealed and bonded to the base layer via a thermoforming process

(iv) At least one intermediate layer disposed between outer layer and the base layer, wherein the intermediate layer includes a region of protective material which is positioned to provide structural protection to at least a portion of the one or more printed circuit board components. [0037] The intermediate layer is formed of a protective material, preferably being a protective material having relatively lower deformability properties than the base layer and the outer layer (for example a semi-rigid or hard plastic). As described in more detail below protective material is thermoformed as a larger layer over the base layer and the one or more printed circuit board components during manufacture, with excess regions of the larger layer removed thereby to define the intermediate layer.

[0038] The intermediate layer provides the structural protection through any or a combination of the following: (i) being configured to provide an impact shield protection underlying the portion of the one or more printed circuit board components; (ii) inhibiting flex in the mouthguard at a region including the portion of the one or more printed circuit board components; and (iii) being configured to able to laterally shear relative to underlying the portion of the one or more printed circuit board components.

[0039] In the embodiment described below, where there is a single PCB, a single region of hard plastic is positioned to provide an impact shield to substantially all PCB surface area overlying the outer faces of teeth (but not covering the occlusal area). In some embodiments the intermediate layer includes multiple regions of hard plastic material.

[0040] The term “mouthguard fitting region” is used to provide a functional definition of the region of a subjects body over which a mouthguard is worn (i.e. a region “encapsulated” by the mouthguard). This typically includes a region of the teeth and gums, however the precise size and coverage of a mouthguard may vary based on a range of factors (such as design, purpose, peculiarities of the user, and so on). The present technology is directed primarily towards athletic mouthguards, being athletic mouthguards used to protect the upper teeth. It will be appreciated that other forms of mouthguard may be manufactured via the techniques disclosed herein, including mouthguards which additionally/alternately protect the lower teeth.

[0041] In a preferred embodiment the mouthguard is constructed such that the intermediate layer provides a region of relatively low deformability plastic material which is able to laterally shear relative to the portion of the one or more printed circuit board components in respect of which it is positioned to provide structural protection. That is, the region of hard plastic material is not bonded to the PCB/instrumented components. In this manner, the hard plastic is able to shear relative to the PCB components, and transfer an impact force through the front of the mouthguard more effectively into the resilient plastics of the base layer (hence reducing the risk of damage to instrumented components and the like).

[0042] In some embodiments, the region of protective material is securely coupled to the outer layer for example as a result of a forming process, such as a thermoforming process (for example a vacuum/pressure forming process).

[0043] Preferably, the mouthguard is formed by a process whereby the region of protective material is thermoformed with respect to the base layer and the one or more printed circuit board components, with the thermoforming occurring after the one or more printed circuit board components securely fixed to the base layer. This allows for the region of protective material to confirm closely in shape to the base layer and the one or more printed circuit board components. This process optionally includes thermoforming a larger region of protective material with respect to the base layer and the one or more printed circuit board components; and trimming the larger region of protective material thereby to define the region of protective material. This trimming is preferably facilitated by applying one or more protective covers to the base layer thereby to prevent bonding of the protective material of the intermediate layer to areas of the base layer to which the one or more protective covers are applied during thermoforming of the intermediate layer.

[0044] Example manufacturing processes are described below, by reference to a particular instrumented component configuration. However, it will be appreciated that mouthguard constructions and mouthguard construction techniques using the underlying technology disclosed herein are applicable to a wide range of other instrumented component configurations.

Example Instrumented Component.

[0045] FIG 1 illustrates an instrumented component 100 according to a further embodiment, this being configured for mounting in a mouthguard body thereby to provide an instrumented mouthguard.

[0046] As shown in FIG. 1 , component 100 is defined by a flexible circuit board substrate which is configured such that one or more conductive members electronically couple component zones (e.g. printed circuit board regions). The flexible circuit board in this manner defines a conductive member which is irregularly shaped such that it is configured to enable fitting of the component zones at desired locations on mouthguard bodies of varied shapes and sizes. More particularly, a PCB is formed to meander between component zones in a manner that allows for customisable fitting, whilst providing for added flexibility and robustness when the mouthguard is used. This presents a significant advantage over non-meandering PCBs, or the use of wires interconnecting distinct PCBs.

[0047] The PCB substrate illustrated in FIG. 1 may be of variable thickness, and/or have rigidity supports applied, thereby to adjust rigidity on a special basis thereby to protect PCB components as required for robustness.

[0048] Component 100 includes three component zones:

• A right-side component zone 130. In some implementations the right-side component zone is configured to support PCB components including an accelerometer(3-axis) wireless communications unit, memory and microprocessor.

• A frontal component zone 120. In some implementations, component zone 120 is split thereby to provide an accelerometer supporting zone configured to be positioned on the outer side of the front teeth (for a 3-axis accelerometer).

• A left side component zone 110. In some implementations the left side component zone provides mounting locations for an accelerometer (3-axis), battery charging unit and a battery mounting location.

[0049] The positioning of components described above, and shown in FIG. 1 , is an example only, and in other embodiments alternate configurations of components are distributed between the component zones.

[0050] A flexible connector member, defined by part of the PCB substrate onto which conductors connects these zones, has a first segment 181 which electronically couples right size component zone 130 and frontal component zone 120, and a second segment 182 which electronically couples front component zone 120 and left side component zone 110.

[0051] The flexible connector member provides a flexible substrate onto which conductive strips and a plurality of PCB components are mounted (for example PCB components in zones 110, 120 and 130). In some embodiments the flexible substrate has an increased thickness in certain regions thereby to provide increased rigidity for PCB components that are susceptible to damage as a result of PCB flexion (for example see regions 111 , 112 and 113 discussed below). In some embodiments additional materials are applied to the flexible substrate thereby to increase rigidity where required.

[0052] In the embodiment of FIG. 1 , zone 130 is defined by three substantially rigid PCB regions 111 , 112 and 113, interconnected by comparatively flexible regions (flex connectors) 114 and 115. This enables a better fit of zone 130 to a curved surface; in the present embodiment it is configured to mounted in a right cheek region of the mouthguard body. Zone 130 includes a range of electronic components, including:

• A 3-axis accelerometer.

• A microprocessor (for example a Qualcomm CSR1012, or BGM13S22F512GA).

• A memory module (for example a Macronix MX25L3233).

• A wireless communications module, in this embodiment being a Bluetooth module coupled to a Bluetooth antenna (not shown), for example, an antenna configured to be mounted such that it runs across a frontal region of the mouthguard forward of a wearer’s teeth.

• A coupling port to a programming tab (not shown).

• A Light-Emitting Diode configured to be visible through the mouthguard body (not shown), in order to provide a device state indication to a user. For example, this is configured to be positioned behind the wearer’s top lip.

• An in-mouth detection (IMD) component, which assists in determining whether the mouthguard is being worn, for example a light sensor or proximity sensor. In some embodiments IMD functionalities are alternately performed via algorithms.

[0053] In alternate embodiments, some of the above components are instead provided in zone 130, zone 110 or zone 120. For example, the microprocessor and memory module are in some embodiments provided in zone 130. [0054] It should be appreciated that the variations in rigidity within zone 110 (and across the component generally) is selected based at least in part of PCB components that are to be mounted at the various locations. For example, in one embodiment one or more of regions 111 , 112 and 113 is not rigid, thereby to allow improved curvature upon application to the mouthguard body, and PCB components mounted to the non-rigid region are selected and/or mounted in such a manner to remain robust in spite to flexion in the PCB substrate.

[0055] Zone 120 includes a PCB region 122 including a 3-axis accelerometer (which is configured to be mounted to the mouthguard body in a location that in use is positioned behind front teeth).

[0056] Zone 110 is configured to be mounted on a left cheek region of the mouthguard body, and includes a PCB that carries a 3-axis accelerometer 111 , along with a charging coil 112 to enable wireless charging of a battery unit 113.

[0057] In other implementations the battery unit is located in zone 110 or zone 120. In further embodiments additional components including the likes of gyroscopes may also be present at one or more of the component zones (for example a gyroscope in combination with an accelerometer at each component zone).

[0058] Segment 181 of the conductive member is configured such that, upon mounting to the mouthguard body, it traverses across a bottom region of the mouthguard body at a region approximately adjacent cuspid and first bicuspid (or, alternately, first and second teeth). This allows zone 120 to be provided on an internal region (behind teeth) and zone 110 provided on an external region (in front of teeth). A sealing cover is mounted to the body thereby to seal components mounted on both the outer side of the body relative to the protective channel thereby to cover and the inner side of the body relative to the protective channel.

[0059] FIG. 12A to FIG. 12D show example views of a mouthguard 1200 formed using PCB 100.

Example Mouthguard Manufacture Process

[0060] As noted, embodiments include methods for manufacturing of instrumented mouthguards. FIG. 2 provides a method according to one embodiment. It will be appreciated that this method could be applied to the instrumented component of FIG. 1 , or in other situations. An example mouthguard manufacturer process will now be described by reference to FIG. 2 and other diagrams, which provide contextual images. It will be further appreciated that this process is specifically tailored to formation of mouthguard including instrumented component 100, or a similar shaped variant thereof. In alternate embodiments the process is adapted to work with other instrumented components (or sets of instrumented components).

[0061] Block 201 represents illustrates a base layer formation process. For the purposes of this example, that process is performed using a known 3D mouthguard forming technique, which custom forms a mouthguard based on a prior step of 3D scanning a subject’s mouthguard fitting region, thereby to allow manufacture a detention mould based on that 3D scan. The base layer is formed using that detention mould, for example via a thermoforming process. Preferably, the base layer is formed of a 1mm medical grade resilient plastics material, as is customary for protective athletic mouthguards. Greater thicknesses may be chosen depending on user preference, or to meet application/jurisdiction specific requirements. This may include a metallocene material, such as a cross-polymer metallocene catalyzed mouthguard (for example, BRITEGUARD PLUS brand mouthguard material may be used). In some embodiments conventional EVAbased mouthguard materials may be used.

[0062] Block 202 represents a base layer trimming process. This trimming process is performed based on space requirements for the PCB that is to be applied. In this example, the trimming process includes applying the bottom layer to the dentition mould, and cutting the blank at the palatal cusps for the molars. The current stops at the end of the tooth #6 (the first molar). Some additional length is left at the #3 (canine), preferably approximately 5mm palatal of the anterior teeth (see FIG. 3A).

[0063] Block 203 represents a PCB mounting process, whereby the PCB component is mounted to the base layer (for example using adhesives such as EVA hot melt and biocompatible adhesive). As shown in FIG. 3B, this includes roughly aligning the centre of the PCB to the middle of teeth 1 & 2 (central incisors). First, EVA hot melt and biocompatible adhesive is applied to the PCB which is then secured into position. Following this, excess adhesive is removed to prevent the chances of de-bonding during the lamination period. [0064] As shown, PCB components on the PCB are positioned to face outwards. Preferably, a serial number is printed on the opposite side of the PCB, such that the serial number faces the bottom layer (which is preferably formed of transparent material, thereby to enable reading of the serial number once the mouthguard is constructed).

[0065] It is better to add too much EVA hot melt, squeeze out and remove excess EVA hot melt to ensure that the PCB is backfilled properly to reduce the risk of the PCB breaking during thermoforming.

[0066] As shown in FIG. 3C, the process includes continuing to adhere the remaining wings of the PCB (zones 100 and 130). It is preferable that these are positioned no higher than the occlusal plane of the 6 (molars).

[0067] FIG. 4A, 4B and 4C show the mouthguard following the PCB mounting process of block 203.

[0068] Block 204 represents a gap filling an edge management process, which is performed thereby to protect the PCB during later processes, and also to prevent sharp edges in the outer surface of the final mouthguard. This preferably includes:

• As shown in FIG. 5A, using either hot glue or EVA hot melt (Erkoflex 82 sticks or similar) to backfill any holes or undercuts along the PCB. Failure to fill in gaps between the PCB and bottom layer may cause the PCB to break during thermoforming of the outer layer. It will be appreciated that EVA hot melt dries clear, bonds and blends in well with the 1mm clear blank used for the base layer.

• As shown in FIG. 5B, using EVA to cover any sharp corners of the PCB. This is to prevent the PCB from protruding through the mouthguard blank during application of the outer layer. Preferably, this includes applying a small amount of EVA hot melt at the bulkier edges of the PCB so that the edges are less harsh. This prevents the PCB protruding less after thermoforming of the outer layer.

[0069] Block 205 represents a process including preparing for application of an intermediate layer. As noted above, this intermediate layer disposed between outer layer and the inner (base) layer, and includes a region of protective material (for example (Erkodur-S at a thickness of 0.8mm) which is positioned to provide an impact shield to at least a portion of the one or more printed circuit board components. The protective material is preferably clear, for example so that it does not interfere with LED or insertion sensors as discussed further below.

[0070] The preparation process includes placing the dentition in thermoforming granules, spreading the granules in areas where the intermediate layer is not required to bond during thermoforming. A covering, for example plastic paper, is positioned in various locations to prevent bonding of the intermediate later to the base payer. This includes placing plastic paper over the occlusal area, including the middle accelerometer (i.e. component zone 120).

[0071] A key objective is for the intermediate layer to overlap the protected PCB regions, with minimal extension beyond that. This assists with shear forces, and also bonding (as there will later in the process be a need to allow the outer layer to make contact to the bottom layer on the peripheries for bonding purposes). This means there must be adequate space between the between intermediate layer (see line 601) and the mouthguard cut (line 602) so that top and bottom layer can bond together.

[0072] The preparation process in this example includes applying plastic paper pieces in required areas to prevent unwanted bonding. Example pieces are shown in FIG. 6F and FIG. 6G.

• Pieces 611 and 615 are used to prevent edges of the bottom layer bonding to middle layer, thereby to ensure bonding between top and bottom layer is at its strongest (which in turn prevents water ingress).

• Pieces 612, 613, and 614 are used to prevent edges of bottom layer bonding to the intermediate layer AND to prevent the intermediate layer bonding to occlusal area.

• Piece 616 is optionally placed over the battery, in the event that the inherent added thickness of the battery combined with the intermediate layer is deemed to provide discomfort to a user (that is, in this case the intermediate later is not formed over the battery).

[0073] It will be appreciated that plastic pieces are examples only, and that other coatings may be used to prevent bonding of the intermediate layer to the base layer (thereby to facilitate removal of unwanted regions of the intermediate layer material following thermoforming). For example, 3D printed templates may be used, and/or removable biocompatible chemical coatings.

[0074] With these in place, a piece of protective material (for example Erkodur-S at a thickness of 0.8mm) is overlaid for thermoforming of the intermediate layer, and thermoforming is performed (block 206). This in the present example embodiment produces a result as shown in FIG. 6I.

[0075] Block 207 represents a process including trimming and finishing of the intermediate layer. In particular, after thermoforming, the intermediate layer is trimmed to substantially match the shape and position of underlying protected PCB regions. It is also trimmed such that that the user will not be able to feel the intermediate layer when biting down. The trimming is facilitated by coverings placed on the base layer to prevent bonding of the intermediate layer to the base layer (these coverings are at this stage removed). After trimming, some areas of the component zones may protrude more than desirable. In particular, when thermoforming the outer layer over the PCB, the region shown by item 620 in FIG. 6H may cause a sharp edge. This is optionally rectified by adding EVA hot melt or melted mouthguard material to fill the cavity that may exist in the red area under adjacent the intermediate layer.

[0076] Block 208 represents a 3D scanning process. This is optionally performed earlier in the process (for example between block 203 and block 207), but must be performed prior to thermoforming of the outer layer at block 209. Other machines such as CMMs, coordinate measuring machines, may be used in place of a 3D scan for this stage.

[0077] The 3D scan of the mouthguard is required to identify the exact location of the sensors for a particular custom built mouthguard; this is used to calibrate the data recorded during use of the instrumented mouthguard. The scanning is performed thereby to enable accurate determination of the position/relative positions of the various motion sensor components. This is optionally then used during a calibration process which allows determination of those components relative to the subject’s head (for example of the centre of gravity) when the mouthguard is worn.

[0078] FIG. 7A illustrated the semi-constructed mouthguard positioned for 3D scanning. FIG. 7B illustrates an acceptable scan where sensor positions and PCB component edges are visible. FIG. 7C shows a scan that has failed due to double imaging. FIG. 7D shows another successful scan.

[0079] Block 209 represents a process including thermoforming of the outer layer.

[0080] The outer layer is in some embodiments formed from EVA, or from a metallocene material such as a cross-polymer metallocene catalyzed mouthguard (for example, BRITEGUARD PLUS brand mouthguard material may be used).

[0081] In some embodiments, the outer layer is formed from a multi-layer laminate, for example a 3mm dual laminate layer is used, with 2mm of coloured resilient plastics (for example white), and 1 mm of clear plastics. A single 3mm layer may alternatively be used for the outer layer. The present inventors have found that an outer layer less than 3mm tend to form around the PCB too tightly, exposing the bulk of the PCB. Greater thicknesses may be used depending on user preference.

[0082] The outer layer is applied over the partially constructed guard, and thermoforming operation completed. The outer layer is then cut and trimmed to form a completed guard. This preferably includes cutting as close to the middle sensors (component zone 120) as possible without endangering the bonding of the layers so that the guard clears the palate as much as possible. The guard is then polished and other finishing operations performed (block 211) Examples of a completed (cut and finished) guards are provided in FIG. 11A and FIG. 11 B.

[0083] In some embodiments, the process of Block 209 includes a process which allows one or more PCB components on the PCB to be exposed (this is entirely optional, and not performed in other embodiments). For example, this is relevant in the context of LEDs, and some insertion monitoring sensors (for example where those use a light sensor or the like). This is preferably achieved by placing a stencil unit over the relevant PCB components (and preferably securing this stencil with hot glue), thereby to facilitate locating following thermoforming of the outer layer. An example is shown in FIG 8A and 8B, where a stencil 801 is placed over LED and IMD sensors on the mouthguard PCB (these are covered already by the clear rigid plastic intermediate layer applied at 205-207).

[0084] Stencil 801 is a hollow dome. Application of the stencil results in a hollow bulbous region following thermoforming of the outer layer; this is able to be removed (for example via a cutting operation) thereby to expose covered PCB components during the process of block 210, or subsequently. Such a cutting and exposure process is shown in FIG. 9A to FIG. 9F. Preferably, the cutting operation is performed thereby to cut into the stencil (cutting in the approximate plane of the outer layer), as opposed to cutting around the stencil (i.e. cutting normally to the approximate plane of the outer layer).

[0085] Once the cutting is performed, the process includes peeling away the hot glue that was used to stick the stencil to the PCB, and smooth the edges of the formed window with a hot scalpel, lathe machine or similar. Assuming the stencil was appropriately applied, the relevant PCB components will be visible through the window (as shown in FIG. 10). If this is not the case, there may be a need to trim the window edges further. The process then includes buffing any rough surface around the window, but leaving the window edges formed from the outer layer plastics sufficiently thick to support EVA being applied into the window. Leaving this thick allows more EVA which results in greater protection for the sensors during use. EVA is then applied to seal the window, thereby providing a clear protective coating to the exposed PCB components. It is important to minimise imperfections such as bubbles in the EVA, as these may alter the performance of the PCB components such as insertion sensors.

[0086] In some embodiments the outer layer is formed as a multi-stage process, with a first sub-layer being formed (for example using a metallocene material such as BRITEGUARD PLUS), and a subsequent outer clear sub-layer. Printed material (or example names, serial numbers, branding, and the like) may be sandwiched between these sub-layers. This approach is preferably performed with the outer clear sub-layer being thermoformed over the guard following completion of the window forming process, thereby to provide additionally provides improved sealing to the window.

[0087] By the technology disclosed above, a thermoforming process is able to be used thereby to manufacture an instrumented mouthguard device having at least three layers, including resilient base and outer layers, and a rigid intermediate layer which protects PCB components. The rigid intermediate layer is sized to approximately match the location of protected PCB regions, and is able to shear relative to those regions (i.e. the intermediate layer is not bonded to the PCB). Accordingly, upon impact to the mouthguard, the force tends to be translated from the outer layer to the base layer around the PCB, rather than through the PCB. [0088] It should be appreciated that in the above description of exemplary embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, FIG., or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment of this invention.

[0089] Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those skilled in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

[0090] In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

[0091] Similarly, it is to be noticed that the term coupled, when used in the claims, should not be interpreted as being limited to direct connections only. The terms "coupled" and "connected," along with their derivatives, may be used. It should be understood that these terms are not intended as synonyms for each other. Thus, the scope of the expression a device A coupled to a device B should not be limited to devices or systems wherein an output of device A is directly connected to an input of device B. It means that there exists a path between an output of A and an input of B which may be a path including other devices or means. "Coupled" may mean that two or more elements are either in direct physical or electrical contact, or that two or more elements are not in direct contact with each other but yet still co-operate or interact with each other.

Thus, while there has been described what are believed to be the preferred embodiments of the invention, those skilled in the art will recognize that other and further modifications may be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as falling within the scope of the invention.

Claims

1. An instrumented mouthguard device including: a base layer, formed of deformable material, wherein the base layer is formed to encapsulate a subject’s mouthguard fitting region; one or more printed circuit board components; an outer layer which is sealed with respect to the base layer, such that the sealing of the outer layer with respect to the base layer protects the one or more printed circuit board components from ingress of fluids; and at least one intermediate layer disposed between outer layer and the base layer, wherein the intermediate layer includes a region of protective material which is positioned to provide structural protection to at least a portion of the one or more printed circuit board components.

2. An instrumented mouthguard according to claim 1 wherein the protective material is a material having relatively lower deformability properties than the base layer.

3. An instrumented mouthguard according to claim 1 wherein the protective material is a material having relatively lower deformability properties than the base layer, and relatively lower deformability properties than the outer layer.

4. An instrumented mouthguard according to any preceding claim wherein the protective material is thermoformed as a larger layer over the base layer and the one or more printed circuit board components during manufacture, with excess regions of the larger layer removed thereby to define the intermediate layer.

5. An instrumented mouthguard according to claim 4 wherein, during manufacture, a covering is applied beneath the protective material prior to thermoforming of the larger layer thereby to prevent bonding of the larger layer to the base layer, thereby to facilitate the removal of the excess regions of the larger layer.

6. An instrumented mouthguard device according to any preceding claim wherein the region of protective material provides the structural protection through being configured to laterally shear relative to underlying the printed circuit board components. An instrumented mouthguard device according to any preceding claim wherein the region of protective material provides the structural protection through being configured to provide an impact shield protection underlying the portion of the one or more printed circuit board components. An instrumented mouthguard device according to any preceding claim wherein the region of protective material provides the structural protection through inhibiting flex in the mouthguard at a region including the portion of the one or more printed circuit board components. An instrumented mouthguard device according to any preceding claim wherein the region of protective material provides the structural protection through two or more of the following: (i) being configured to provide an impact shield protection underlying the portion of the one or more printed circuit board components; (ii) inhibiting flex in the mouthguard at a region including the portion of the one or more printed circuit board components; and (iii) being configured to able to laterally shear relative to underlying the portion of the one or more printed circuit board components. An instrumented mouthguard device according to any preceding claim wherein the region of protective material provides the structural protection through: (i) being configured to provide an impact shield protection underlying the portion of the one or more printed circuit board components; (ii) inhibiting flex in the mouthguard at a region including the portion of the one or more printed circuit board components; and (iii) being configured to able to laterally shear relative to underlying the portion of the one or more printed circuit board components. An instrumented mouthguard device according to any preceding claim wherein the region of protective material is securely coupled to the outer layer. An instrumented mouthguard device according to any preceding claim wherein, in use, the region of protective material substantially covers outer faces of the subject’s teeth. An instrumented mouthguard device according to any preceding claim wherein the region of protective material thermoformed with respect to the base layer and the one or more printed circuit board components. An instrumented mouthguard device according to any preceding claim wherein the region of protective material is thermoformed with respect to the base layer and the one or more printed circuit board components, with the thermoforming occurring after the one or more printed circuit board components securely fixed to the base layer An instrumented mouthguard device according to any preceding claim wherein the region of protective material is thermoformed with respect to the base layer and the one or more printed circuit board components via a process including: thermoforming a larger region of hard plastic with respect to the base layer and the one or more printed circuit board components; and trimming the larger region of hard plastic thereby to define the region of hard plastic. An instrumented mouthguard device according to claim 15 wherein the thermoforming includes applying one or more protective covers to the base layer thereby to prevent bonding of the hard plastic to areas of the base layer to which the one or more protective covers are applied. An instrumented mouthguard device according to any preceding claim wherein the one or more printed circuit board components includes a flexible printed circuit board which is affixed to the base layer, the flexible printed circuit board having one or more component zones which are positioned to overlie outer tooth face regions, and wherein the region of hard plastic overlies the one or more component zones. An instrumented mouthguard device according to any preceding claim including a transparent window formed in the outer layer thereby to reveal one or more PCB components. A method of manufacturing an instrumented mouthguard, the method including: forming a base layer using a detention mould; 22 mounting one or more printed circuit board components directly or indirectly to the base layer; applying one or more coverings to the base layer at predefined locations, and subsequently forming a protective intermediate layer to the base layer, wherein the one or more coverings applied to the base layer prevent bonding of the intermediate layer to the base layer at the predefined locations; trimming the intermediate layer such that the intermediate layer is positioned to provide structural protection to at least a portion of the one or more printed circuit board components, and leaves exposed sufficient surface area of the base layer as to allow bonding of a thermoformed outer layer; and forming an outer layer over the base layer and intermediate layer. A method according to claim 19 wherein the detection mould is customised for a subject. A method according to claim 19 or claim 20 wherein the intermediate layer is a material having relatively lower deformability properties than the base layer. A method according to claim 19 or claim 20 wherein the protective material is a material having relatively lower deformability properties than the base layer, and relatively lower deformability properties than the outer layer. A method according to one of claims 19 to 22 wherein the intermediate layer provides the structural protection through being configured to laterally shear relative to underlying the printed circuit board components. A method according to one of claims 19 to 23 wherein the intermediate layer provides the structural protection through being configured to provide an impact shield protection underlying the portion of the one or more printed circuit board components. A method according to one of claims 19 to 24 wherein the intermediate layer provides the structural protection through inhibiting flex in the mouthguard at a region including the portion of the one or more printed circuit board components. 23 A method according to one of claims 19 to 22 wherein the intermediate layer provides the structural protection through two or more of the following: (i) being configured to provide an impact shield protection underlying the portion of the one or more printed circuit board components; (ii) inhibiting flex in the mouthguard at a region including the portion of the one or more printed circuit board components; and (iii) being configured to able to laterally shear relative to underlying the portion of the one or more printed circuit board components. A method according to one of claims 19 to 22 wherein the intermediate layer provides the structural protection through: (i) being configured to provide an impact shield protection underlying the portion of the one or more printed circuit board components; (ii) inhibiting flex in the mouthguard at a region including the portion of the one or more printed circuit board components; and (iii) being configured to able to laterally shear relative to underlying the portion of the one or more printed circuit board components. A method according to one of claims 19 to 27 including forming a transparent window in the outer layer thereby to reveal one or more PCB components. A method according to claim 28 wherein forming the transparent window includes: (i) applying a stencil over the one or more PCB components, such that the stencil defines a hollow dome over the one or more PCB components; (ii) thermoforming the outer layer over the stencil; (iii) cutting through the outer layer and stencil thereby to form the window; and (iv) applying a transparent sealing substance thereby to seal the window. A method of forming an instrumented mouthguard, the method including: (i) forming a base layer which mounts to a user’s mouthguard fitting region; (ii) mounting one or more PCB components directly or indirectly to the base layer; (iii) applying a stencil directly or indirectly over the one or more PCB components, such that the stencil defines a hollow dome over the one or more PCB components; (iv) thermoforming the outer layer over the stencil; (v) cutting through the outer layer and stencil thereby to form the window; and (vi) applying a transparent sealing substance thereby to seal the window.