GB2570895A

GB2570895A - A gum shield configured to detect concussion

Info

Publication number: GB2570895A
Application number: GB1802049.5A
Authority: GB
Inventors: Margaret Fisher Heather
Original assignee: Individual
Current assignee: Individual
Priority date: 2018-02-08
Filing date: 2018-02-08
Publication date: 2019-08-14
Also published as: GB201802049D0

Abstract

A gum shield comprising a body configured to fit over the upper teeth and gum of a wearer; and a sensor mounted on or in the body of the gum shield, the sensor configured to detect one or more chemical biomarkers in saliva of the wearer indicative of concussion and generate a signal in order to indicate that the wearer is exhibiting symptoms of concussion. In embodiments the biomarker is microRNA (mRNA). In embodiments an audio or visual indication may be provided to an official or coach that a specific player is exhibiting symptoms of concussion.

Description

A GUM SHIELD CONFIGURED TO DETECT CONCUSSION

Field of Invention

The present specification relates to a gum shield (also known as a mouth guard) which is configured to indicate when a wearer is exhibiting symptoms of concussion. The gum shield is particularly suited for use in contact sports such as rugby and American football in order to give a real-time indication that a player is exhibiting symptoms of concussion during play.

Background of Invention

Gum shields are commonly worn by players of contact sports such as rugby, American football, boxing, and mixed martial arts. Gum shields generally comprise a moulded plastic body which is shaped to fit over the upper teeth and gum of a wearer, primarily to protect the wearer's teeth upon impact.

A number of different types of gum shield are known in the art which have been modified to detect potentially concussive impacts and give an indication of such an impact so that a player can be assessed and potentially withdrawn from play. Examples of such gum shields are described in US2015023814, US20170071526, US20110184319, US20130211270, and US20150119759. A common theme of such gum shields is that they comprise a sensor system which detects an impact force and provides a signal when an impact force is above a threshold level which could potentially cause a concussion. The specifics of the systems vary. The impact sensor can be an accelerometer which produce an electric signal activating an LED light indicator when an impact force is above a threshold level. Alternatively, the gum shield can be provided with capsules of dye chemicals which rupture, mix, and change colour when an impact force is above a threshold level.

An example of a commercially available product is the FITGuard™ Head-Injury awareness mouthguard. This product is also of the impact sensing type. It comprises an accelerometer system mounted in the gum shield body which provides a combined measurement of linear and angular acceleration. An LED lighting system is also mounted in the gum shield and is activated when an impact force is above a threshold level. The gum shield is also provided with a wireless transmitter for transmitting data to another device such as a smart phone.

All of the aforementioned configurations are based on an impact measurement and the prediction that over a threshold level this may cause concussion. If the threshold level is set too low then such systems will give a large number of false indications leading to undue disruption to a game and potential removal of players who are not concussed. On the other hand, if the threshold level is set too low then such systems will not detecting a proportion of concussions risking the health of players. In fact, given that different people will have a different susceptibility to concussion it is impossible to set a threshold impact level which is correct for every individual.

The present invention is concerned with the provision of a gum shield which gives a more reliable indication of concussion in a wearer regardless of the type, force, or direction of impact experienced by the wearer and varying susceptibility of a wearer to concussion.

Summary of Invention

According to one configuration as described herein, there is provided a gum shield comprising:

a body configured to fit over the upper teeth and gum of a wearer; and a sensor mounted on or in the body of the gum shield, the sensor configured to detect one or more biomarkers in saliva of the wearer indicative of concussion and further configured to generate a signal when the one or more biomarkers are detected in the saliva of the wearer.

In the aforementioned configuration, symptoms of concussion in a wearer are measured directly and thus the system works independently of the type, force, or direction of impact experienced by the wearer of the gum shield and is also independent of the varying susceptibility of a wearer to concussion. As such, a relatively low impact force causing concussion can be detected in a wearer who has a high susceptibility to concussion. Similarly, a relatively high impact force will not give a false positive for a wearer who isn't concussed either due to the type of impact or because the wearer has a low susceptibility to concussion, i.e. a high concussion threshold. As such, the system is advantageous over the prior art systems which are based on an impact measurement.

The system is based on the recently published research by others disclosing the presence of biomarkers, such as microRNA, in saliva indicative of concussion. Methods have been developed for concussion testing by taking a sample of saliva from a person suspected of being concussed and testing the saliva in vitro, i.e. outside the body in a test-tube type environment or in a dedicated hand held device. Tests have been developed using a polymerase chain reaction methodology to amplify the microRNA including both thermal cycling and isothermal methods. Detection can be via a number of methods including, for example, a change in turbidity, a change in pH, a number of different colour changing dyes, or via use of an electrochemical sensor. Certain techniques such as electrochemical sensing can be significantly more sensitive to low levels of biomarkers and thus amplification of the biomarkers is not necessarily required.

One problem with the aforementioned in vitro testing methods is that a person must be identified as being potentially concussed in order to determine that they should be tested, e.g. at pitch side. One solution to this problem is to utilize a prior art gum shield which measures impact force to identify a potential concussion and then utilize one of the aforementioned in vitro testing methods to confirm whether or not that person is concussed, e.g. at pitch side. However, while this combined method is relatively robust, it can result in many game stoppages due to potential concussions being detected via an impact measuring gum shield which then need to be tested at pitch side to confirm whether or not the person is actually exhibiting biomarkers indicative of concussion.

The present invention is concerned with the realization that an improvement over all the aforementioned techniques can be provided by integrating a biomarker detection technique directly into a gum shield to provide a more reliable indication of concussion in real-time during play.

Brief Description of the Drawings

Embodiments of the present invention are described by way of example only with reference to the accompanying drawings in which:

Figures 1 shows a schematic of a gum shield comprising a sensor configured to detect one or more chemical biomarkers in saliva indicative of concussion;

Figure 2 shows a schematic of a front portion of a gum shield comprising a cavity in which sensing regions are disposed, the sensing regions comprising one or more reactants which react with one or more chemical biomarkers in saliva to indicate a concussion;

Figure 3 shows a schematic of a front portion of a gum shield comprising a cavity in which an electrochemical sensor is disposed for electrochemically sensing one or more chemical biomarkers in saliva to indicate a concussion;

Figure 4(a) shows a schematic of a working electrode of the electrochemical sensor functionalized to bind with one or more target biomarkers in saliva;

Figure 4(b) shows a schematic of the functionalized working electrode with target biomarkers bound to the functionalized working electrode; and

Figure 4(c) shows a cyclic voltammogram plot for the configuration shown in Figure 4(a) and a cyclic voltammogram plot for the configuration shown in Figure 4(b) illustrating a change in the voltammetry signal when target biomarkers are present in saliva and bind to the functionalized electrode.

Detailed Description

Figures 1 shows a schematic of a gum shield comprising a sensor configured to detect one or more chemical biomarkers in saliva indicative of concussion. The gum shield 10 comprises a body 12 configured to fit over the upper teeth and gum of a wearer, primarily to protect the wearer's teeth upon impact. The gum shield body comprises a front wall 14, a rear wall 16, a base 18, and a cavity 20 formed between the front and real walls 14, 16. The front and rear walls 14, 16 are curved to form approximately concentric arcs which define the curved cavity 20 therebetween configured to receive the upper teeth of a wearer.

A sensor 22 is mounted on or in the body of the gum shield, the sensor configured to detect one or more chemical biomarkers in saliva of the wearer indicative of concussion and further configured to generate a signal in order to indicate that the wearer is exhibiting symptoms of concussion. In the illustrated embodiment the sensor 22 is mounted in the front wall 14 of the body of the gum shield. However, the sensor 22 may alternative be mounted in the rear wall 16. Alternatively still, sensors can be provided on and/or in both front and rear walls of the gum shield.

The body 12 of the gum shield 10 may comprise at least one cavity disposed in an outer surface within which the sensor is mounted such that in use the sensor does not protrude from the outer surface of the body of the gum shield. Figure 2 shows a schematic of a front portion of a gum shield comprising a cavity 24 in which sensing regions 26 are disposed. The sensing regions 26 comprise one or more reactants which react with one or more chemical biomarkers in saliva to indicate a concussion.

Alternatively, or additionally, the body 12 of the gum shield may comprise at least a portion which comprises pores which are porous to ingress of saliva in use. Components of the sensor, such as chemical reactants targeted at biomarkers, can then be disposed within the pores.

Mounting sensor components in cavities or pores of the body of the gum shield serves three purposes: (i) increases comfort by ensuring that the feel and fit of the gum shield is not compromised by the sensor; (ii) protects the sensor components; and (iii) achieves (i) and (ii) while still allowing saliva to contact the sensor in order to detect biomarkers in the saliva.

As previously mentioned in the summary section, recently published research by others has disclosed the presence of biomarkers such as microRNA in saliva which are indicative of concussion. See, for example, various publications by Professor Tony Belli et al. (The University of Birmingham) reporting molecules which can be found in saliva and act as biomarkers to indicate concussion (e.g. MicroRNAs as Novel Biomarkers for the Diagnosis and Prognosis of Mild and Sever Traumatic Brain Injury, J. Neurotrauma, 34(11), 1948-1956, 2017). The Belli group have developed a pitch-side testing method which is currently undergoing trials. The present specification proposes to integrate such a methodology into a gum shield by providing a sensor in the gum shield which is configured to detect said microRNA or an alternative chemical biomarker in saliva. For example, the sensor can comprise one or more primers complimentary to the microRNA and a polymerase to amplify the microRNA. In this case, the sensor can be configured to provide an isothermal amplification reaction of the microRNA such as a loop mediated isothermal amplification of the microRNA similar to that described by Feng et al. (Anal. Chem. 89(12), 6631-6636, 207). Alternatively, a more conventional thermal cycling driven amplification reaction can be utilized in which case the sensor integrated into the gum shield can be provided with a heater (e.g. a small microelectrode heater) to provide a thermal cycling driven amplification reaction of the microRNA. In this case, microheaters can provide highly localized thermal heating, e.g. in a cavity within the gum shield, so as to not cause discomfort or burning of the wearer.

The sensor may comprise a dye providing a visual colour change as a result of the presence of the one or more chemical biomarkers in the saliva. Various dyes for use in detecting micro-RNA are known in the art and can be configured to intercalate or directly label the microRNA. Such dyes can be chemical bound to the body of the gum shield and/or provided within pores of the body of the gum shield.

Alternatively, the sensor can be configured to detect a change in pH as a result of the presence of the one or more chemical biomarkers in the saliva using a method similar to that disclosed by Feng et al. (Anal. Chem. 89(12), 6631-6636, 207). In this case, the polymerase chain reaction generates protons which can be simply detected and visually indicated using a pH indicator dye.

While the aforementioned approaches are essentially chemical in nature, another configuration uses an electrochemical sensor approach by integrating an electrochemical sensor into a gum shield. As previously indicated, gum shields are already commercially available that integrate electronics in the form of accelerometers, LEDs, and transmitters to provide impact measurements and data transmission. Compact electrochemical sensor configurations are also available for integration into microfluidic chips. Here, such an electrochemical sensor is integrated into a gum shield.

The electrochemical sensor has an electrochemical electrode configured to generate an electrical signal as a result of the presence of the one or more chemical biomarkers in the saliva. See, for example, Guo et al. Nanotechnology, vol. 24, no. 44 which discloses an example of an electrochemical sensor for highly sensitive, specific, label-free and real-time DNA detection. In such an arrangement, the electrochemical electrode can be functionalized with molecules which bind to the one or more chemical biomarkers. Alternatively, or additionally, the electrochemical sensor can be configured to detect a change in pH, conductivity, or a change in the voltammetric signal as a result of the presence of the one or more chemical biomarkers in the saliva. Such an electrochemical sensor system can readily be adapted and integrated into a gum shield for detection of biomarkers indicative of concussion.

Figure 3 shows a schematic of a front portion of a gum shield body 12 comprising a cavity 24 in which an electrochemical sensor 28 is disposed for electrochemically sensing one or more chemical biomarkers in saliva to indicate a concussion. The illustrated embodiment shows an electrochemical sensor 28 comprising three electrodes: a working electrode 30; a reference electrode 32; and a counter electrode 34. However, electrochemical sensor systems may have only two electrodes or alternatively may comprise more than three electrodes, e.g. an array of electrodes such as a microelectrode array. The electrochemical sensor also comprises a controller 36 for driving the electrodes and detecting changes in current signal.

The sensor may also comprises a light emitting diode configured to emit a light signal when the electrical signal is generated by the electrochemical sensor. Additionally, or alternatively, the sensor may comprise a transmitter 38 configured to transmit a signal to a receiver when the electrical signal is generated. In such a configuration, a system can be provided comprising the gum shield as described herein and a receiver, where the receiver is configured to provide an audio and/or visual indication to an official or coach that a specific player of a game is exhibiting symptoms of concussion.

Figure 4(a) shows a schematic of a working electrode 30 of the electrochemical sensor functionalized to bind with one or more target biomarkers in saliva. For example, the working electrode 30 may be functionalized with nanoparticles 40 and further functionalized with RNA fragments 42 complimentary to the target biomarkers. Figure 4(b) shows a schematic of the functionalized working electrode 30 with target biomarkers 44 bound to the functionalized working electrode. Furthermore, Figure 4(c) shows a cyclic voltammogram plot 46 for the configuration shown in Figure 4(a) and a cyclic voltammogram plot 48 for the configuration shown in Figure 4(b) illustrating a change in the voltammetry signal when target biomarkers are present in saliva and bind to the functionalized electrode. Such a change in voltammetric signal can be used to detect the biomarkers indicative of concussion and this can be signalled via visual, audio, or wireless means as previously described.

While this invention has been described in relation to certain embodiments it will be appreciated that various alternative embodiments can be provided without departing from the scope of the invention which is defined by the appending claims.

Claims

1. A gum shield comprising:

a body configured to fit over the upper teeth and gum of a wearer; and a sensor mounted on or in the body of the gum shield, the sensor configured to detect one or more chemical biomarkers in saliva of the wearer indicative of concussion and further configured to generate a signal in order to indicate that the wearer is exhibiting symptoms of concussion.

2. A gum shield according to claim 1, wherein the one or more biomarkers comprise microRNA present in the saliva of the wearer indicative of concussion and the sensor is configured to detect said microRNA.

3. A gum shield according to claim 2, wherein the sensor comprises one or more primers complimentary to the microRNA and a polymerase to amplify the microRNA.

4. A gum shield according to claim 3, wherein the sensor is configured to provide an isothermal amplification reaction of the microRNA.

5. A gum shield according to claim 4, wherein the sensor is configured to provide a loop mediated isothermal amplification of the microRNA.

6. A gum shield according to any one of claims 1 to 3, wherein the sensor comprises a heater to provide a thermal cycling driven amplification reaction of the microRNA.

7. A gum shield according to any preceding claim, wherein the sensor comprises a dye providing a visual colour change as a result of the presence of the one or more chemical biomarkers in the saliva.

8. A gum shield according to claim 7, wherein the dye is configured to intercalate or directly label the microRNA .

9. A gum shield according to any preceding claim, wherein the sensor is configured to detect a change in pH as a result of the presence of the one or more chemical biomarkers in the saliva.

10. A gum shield according to any preceding claim, wherein the body of the gum shield comprises an outer surface and at least one cavity disposed in the outer surface, and wherein the sensor is mounted within the at least one cavity such that in use the sensor does not protrude from the outer surface of the body of the gum shield.

11. A gum shield according to any preceding claim, wherein the body of the gum shield comprises at least a portion which comprises pores which are porous to ingress of saliva in use, and components of the sensor are disposed within said pores.

12. A gum shield according to any preceding claim, wherein the sensor comprises an electrochemical sensor having an electrochemical electrode configured to generate an electrical signal as a result of the presence of the one or more chemical biomarkers in the saliva.

13. A gum shield according to claim 12, wherein the an electrochemical electrode is functionalized with molecules which bind to the one or more chemical biomarkers.

14. A gum shield according to claim 12 or 13, wherein the electrochemical sensor is configured to detect a change in pH, conductivity, or a change in the voltammetric signal as a result of the presence of the one or more chemical biomarkers in the saliva.

15. A gum shield according to any one of claims 12 to 14, wherein the sensor comprises a light emitting diode configured to emit when the electrical signal is generated.

16. A gum shield according to any one of claims 12 to 15, wherein the sensor comprises a transmitter configured to transmit a signal to a receiver when the electrical signal is generated.

17. A system comprising the gum shield of claim 16 and a receiver, wherein the receiver is configured to provide an audio and/or visual indication to an official or coach that a specific player of a game is exhibiting symptoms of concussion.