Dental splint and mandibular advancement device and method of manufacturing the same

Abstract

There is described a mandibular advancement device, MAD (10). The MAD (10) comprises an upper member and a lower member. The upper member is configured to adapt to the maxilla of the user. The lower member is configured to adapt to the mandible of the user. The MAD (10) comprises a carbon dioxide sensor (30) configured to measure carbon dioxide of exhaled and / or inhaled breath.

Description

[0001] DENTAL SPLINT AND MANDIBULAR ADVANCEMENT DEVICE AND METHOD OF MANUFACTURING THE SAME

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a dental splint for monitoring sport performance and a mandibular advancement device (MAD) and a method for manufacturing a MAD.

[0004] BACKGROUND

[0005] Obstructive sleep apnea is a common nocturnal breathing disorder affecting approximately one billion people worldwide. During apneic episodes, the tongue of the patient falls back, obstructing the airway leading to disrupted sleep, daytime sleepiness and decreased quality of life. Obstructive sleep apnea is also associated with an increased risk of cardiovascular morbidity, with a two-fold increase in stroke risk and a three-fold risk in high blood pressure. It is also considered a major problem for road traffic, because obstructive sleep apnea is associated with a six-fold increase in the risk of drowsy driving accidents.

[0006] One way of treating severe sleep apnea is to use a continuous positive airway pressure machine. However, some patients do not tolerate a continuous positive airway pressure machine, which is associated with a 30% - 50% dropout rate at three years. A MAD is usually better tolerated than a continuous positive airway pressure machine. A MAD allows the mandible to be repositioned and can prevent the tongue from blocking the airway.

[0007] Some users of MADs may experience discomfort such as soreness in the jaw, teeth or temporomandibular joint when using a MAD, particularly initially or if the device is not properly adjusted. While MADs are effective for many people with snoring and mild to moderate obstructive sleep apnea, they may not be as effective for severe cases of sleep apnea or for individuals with certain anatomical characteristics that make them less responsive to mandibular advancement. It is also more difficult for doctors to monitor the efficacy of the treatment when a user is using a MAD compared to when a user is using a continuous positive airway pressure machine (which can monitor breathing continuously).

[0008] EP 3216430 Al discloses an intra-oral device for mandibular adjustment. The device is manufactured using CAD / CAM. The device comprises an upper splint with followers and various lower splints including contact surfaces on which the followers contact, so that on exchanging lower splints for others, according to a manufacturing sequence, they cause different controlled mandibular advancements. WO 2021 / 119535 Al discloses accessories for a MAD. MADs are disclosed comprising an upper splint, a lower splint and at least one sensor that measures a biological or biophysical aspect of a patient.

[0009] The known devices have the drawbacks of potential discomfort, limited efficacy and difficulty in monitoring the efficacy of the treatment.

[0010] SUMMARY OF THE INVENTION

[0011] According to the present invention there is provided a dental splint and a MAD. The dental splint and the MAD comprise a CO2 sensor. The CO2 sensor may be configured to measure the CO2 in exhaled and / or inhaled breath.

[0012] The dental splint and the MAD may be configured to adjust a position of a mandible of a user wearing the dental splint and the MAD. The dental splint and the MAD may comprise a base member. The base member may be configured to adapt to a maxilla of the user. The MAD may comprise a lower member. The lower member may be configured to adapt to the mandible. The base member may comprise an engagement member. The engagement member may be configured to engage with a complementary engagement member of a detachable sensor member so as to lock the sensor member to the base member. The detachable sensor member may comprise a CO2 sensor.

[0013] According to the present invention there is provided a detachable sensor member for the dental splint and the MAD. The detachable sensor member may comprise a CO2 sensor. The CO2 sensor may be configured to measure CO2. The detachable sensor member may comprise an engagement member. The engagement member may be configured to engage with a complementary engagement member of a base member of the dental splint or the MAD so as to lock the sensor member to the base member.

[0014] According to the present invention there is provided a method for manufacturing a MAD. The MAD may be configured to adjust a position of a mandible of a user wearing the MAD. The method may comprise providing a CO2 sensor.

[0015] BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Arrangements of the disclosure will be further described, by way of example only, with reference to the accompanying drawings.

[0017] Figure 1 schematically depicts a MAD;

[0018] Figure 2 is a close-up depiction of part of a MAD;

[0019] Figure 3 is a close-up depiction of part of a MAD; Figure 4 schematically depicts a coupling of a MAD;

[0020] Figure 5 is a diagram showing the range of possible movement of the mandible when the MAD has a coupling with a first set of dimensions;

[0021] Figure 6 is a diagram showing the range of possible movement of the mandible when the MAD has a coupling with a second set of dimensions;

[0022] Figure 7 is a diagram showing the range of possible movement of the mandible when the MAD has a coupling with a third set of dimensions;

[0023] Figure 8 is a diagram showing the range of possible movement of the mandible when the MAD has a coupling with a fourth set of dimensions;

[0024] Figure 9 is a diagram showing the range of possible movement of the mandible when the MAD has a coupling with a fifth set of dimensions;

[0025] Figure 10 schematically depicts a plan view of a MAD or a dental splint;

[0026] Figure 11 is a graph showing the relationship between time and CO2 concentration; Figure 12 schematically depicts a MAD;

[0027] Figure 13 depicts an exemplary display on a device wirelessly connected to a MAD; Figure 14 is a flow chart of a method for manufacturing a MAD; and

[0028] Figure 15 is a flow chart of a method for manufacturing a MAD.

[0029] DESCRIPTION

[0030] Examples of a MAD 10 and components thereof are provided in Figures 1-5. Figure 1 schematically depicts a MAD 10. Figure 1 is a perspective view of the MAD 10.

[0031] As shown in Figure 1, the MAD 10 may comprise an upper member 11. The upper member 11 is configured to adapt to the maxilla of a user of the MAD 10. As shown in Figure 1, the MAD 10 may comprise a lower member 12. The lower member 12 may be configured to adapt to the mandible of the user.

[0032] When the user is in an upright position, the upper member 11 is generally above the lower member 12. When the user is differently oriented or when the MAD 10 is not in use, then the upper member 11 may no longer be above the lower member 12. For example, when the user is lying down, then the upper member 11 and the lower member 12 may be next to each other, with neither above the other vertically. The terms upper and lower refer to the relative relationship of the upper member 11 and the lower member 12 when the MAD 10 is used by a patient in an upright position. The upper member 11 and the lower member 12 may alternatively be referred to as a first member and a second member, for example. The upper member 11 and the lower member 12 may define the directions upwards, downwards, forwards, rearwards and sideways. In the orientation shown in Figure 1, the upwards direction and the downwards direction correspond to the upwards and downwards directions in the picture. In the coordinate system shown in Figure 1, the upwards direction corresponds to the +Z direction. The downwards direction corresponds to the -Z direction. The forwards direction corresponds to the +X direction. The rearwards direction corresponds to the -X direction. The forwards direction is the direction in which the user faces. The rearwards direction is opposite to the forwards direction. The sideways direction refers to the directions parallel to the Y-axis in Figure 1.

[0033] In use, the MAD is configured to adjust the position of the mandible of the user relative to the maxilla. The MAD is configured to advance the mandible. Advancement refers to movement in the forwards direction.

[0034] Optionally, the MAD 10 is configured to apply a forwards and upwards force on the mandible so as to tension a hyoid bone of the user via their genial tubercles. The MAD 10 may be configured to guide mandibular advancement in a forwards and upwards direction. By guiding the mandibular advancement forwards and upwards, the genial tubercles may be advanced. This may help to increase the tension in the hyoid bone and attached tongue muscles to clear the airway. For a given level of mouth openness, the tension on the hyoid bone and attached tongue muscles may be increased, and optionally maximised.

[0035] By increasing the tension on the hyoid bone, the airway may be more clear. The MAD 10 may be more effective. For example, the MAD 10 may be effective for people with snoring and mild to moderate obstructive sleep apnea. The MAD 10 may further be effective for more severe cases of sleep apnea.

[0036] By applying a forwards and upwards force on the mandible, the force applied by the MAD 10 may be in a direction that is parallel or nearly parallel to the direction of the genial tubercles between the hyoid bone and the mandible. The force applied by the MAD 10 may contribute to the tension on the genial tubercles, which help to tension the hyoid bone, thereby clearing the airway. The MAD 10 may be configured to apply the force only if the mandible tends to move down or back. If the patient voluntarily positions the mandible in the forward and upward position, the patient will not feel the force. The MAD 10 is configured to restrict the position of the lower member 12 relative to the upper member 11 in the downwards and backwards directions. When the mandible moves to the limits of its position allowed by the MAD in the backwards and / or downwards directions, then the MAD 10 applies the forwards and upwards force on the mandible. Optionally, the MAD 10 is configured to apply the forwards and upwards force passively dependent on a position of the lower member 12 relative to the upper member 11. For example, the MAD 10 may be configured such that the lower member 12 is movable relative to the upper member 11 within a range within which the forwards and upwards force is not applied.

[0037] The MAD 10 may be configured to restrict vertical movement of the lower member 12 relative to the upper member 11 to a restricted range. Optionally, the restricted range decreases as the lower member 12 moves backwards relative to the upper member 11.

[0038] Optionally, the MAD 10 is configured to restrict a vertical position of the lower member 12 relative to the upper member 11 to a lowest vertical position. The lowest vertical position is the lower limit of the range of positions of the lower member 12 relative to the upper member 11. Optionally, the lowest vertical position is higher as the lower member 12 moves backwards relative to the upper member 1 l.The forwards and upwards motion is guided by the MAD 10. In contrast, known MADs do not limit the downward movement which results in possible downward movement of the patient’s mandible.

[0039] Optionally, the MAD 10 is configured such that the mandible follows a biomimetic path. The MAD 10 is configured to cause the mandible to move in a way that mimics the natural mandibular movement. The MAD 10 may be aligned in use to substantially avoid tongue-induced airway blockage at various mandibular positions, for example over a range of different mandibular positions. The MAD 10 may be configured to mechanically limit and guide mandibular movement during mouth openness. The MAD 10 is expected to reduce discomfort experienced by the user. For example, the MAD 10 may reduce discomfort for soreness in the j aw, teeth or temporomandibular j oint when using the MAD 10. The MAD 10 may encourage use of the MAD 10 by being more comfortable than known MADs.

[0040] Optionally, the MAD 10 is configured to apply an upwards force on the mandible that increases as the lower member 12 moves forwards relative to the upper member 11. During use of the MAD 10, the MAD 10 is configured to limit the most backward and downward position of the mandible to a more front and upward range of motion. Optionally, the range of motion is substantially biomimetic. This helps to maximise the minimum tension of the hyoid bone, resulting in increased airway openness. When the backward and downward position of the mandible is limited, the MAD 10 applies the forwards and upwards force on the mandible. The MAD 10 may be configured to apply the forwards and upwards force passively. The forwards and upwards force may be a reaction force resulting from the mandible of the user tending towards a rearwards and downwards position. Optionally, when the mouth is least open (e.g. when the mouth is closed), the upwards force applied by the MAD 10 may be at or near its minimum. Optionally, when the mouth is closed, the MAD 10 is configured to apply substantially no upwards force on the mandible. As mouth openness increases, the MAD 10 is configured to advance the mandible. The lower member 12 moves forwards relative to the upper member 11. As mouth openness increases, the upwards force on the mandible applied by the MAD 10 increases.

[0041] Optionally, the MAD 10 is configured such that as mouth openness increases, the direction of the forwards and upwards force on the mandible changes. In particular, as the mouth openness increases, the direction of the forwards and upwards force becomes more upwards. Optionally, at the maximum level of mouth openness allowed by the MAD 10, the forwards and upwards force is substantially upwards. At the maximum limit of mouth openness, the forwards force may be at its minimum, or may be substantially zero.

[0042] By providing that the direction of the force applied by the MAD 10 on the mandible varies as the mouth opens, the range of motion of the mandible may be more biomimetic. This may help to increase the comfort of the user. This may also help to increase the tension on the hyoid bone, thereby increasing the openness of the airway.

[0043] As shown in Figure 1, optionally the upper member 11 is coupled to the lower member 12 so as to restrict rearwards movement of the lower member 12 relative to the upper member 11. The MAD 10 may prevent the most rearwards positions of the mandible so as to limit closure of the airway.

[0044] Optionally, the upper member 11 is coupled to the lower member 12 so as to restrict downwards movement of the lower member 12 relative to the upper member 11. The MAD 10 may limit the extent to which the mouth may be opened. The MAD 10 may be configured to prevent the most downward positions of the mandible. The most backwards and downwards positions of the mandible generally correlate to the locations creating the most obstruction to the airway. By limiting the most backward and downward positions of the mandible, the obstruction of the airway may be reduced.

[0045] As shown in Figure 1, optionally the MAD 10 comprises a coupling 13. As shown in Figure 1, the coupling 13 may connect the upper member 11 and the lower member 12. The coupling 13 may help the movement of the mandible to be guided by the MAD 10. The coupling 13 may help to guide the range of possible motion and the range of possible positions of the lower member 12 relative to the upper member 11.

[0046] Optionally, one of the upper member 11 and the lower member 12 comprises a guide surface 14. The guide surface 14 may be for sliding engagement with the coupling 13. The sliding engagement may transfer the forwards and upwards force between the guide surface 14 and the coupling 13.

[0047] For example, Figure 1 shows an arrangement in which the upper member 11 comprises the guide surface 14. The coupling 13 connects the lower member 12 to the upper member 11. In the position shown in Figure 1, the guide surface 14 is not engaged with the coupling 13. However, typically during use of the MAD 10, the guide surface 14 may be engaged with the coupling 13. When the guide surface 14 is in contact with the coupling 13, the guide surface 14 imposes a force on the coupling 13. The force is forwards and upwards (i.e. in the +X direction and the +Z direction). As shown in Figure 1, the guide surface 14 generally faces forwards and upwards.

[0048] As shown in Figure 1, optionally the coupling 13 comprises an engagement member 16. The engagement member 16 is configured to engage with the guide surface 14. The guide surface 14 imposes a force on the engagement member 16. The coupling 13 may comprise an uplift arm 18. The uplift arm 18 may be longitudinal. The uplift arm 18 may extend primarily vertically between the lower member 12 and the upper member 11 of the MAD 10. During use, the angle of the uplift arm 18 may vary. The engagement member 16 may be fixed relative to the uplift arm 18. When the guide surface 14 applies a force on the engagement member 16, the force is transferred to the uplift arm 18. The uplift arm 18 may transfer the force to the lower member 12. The lower member 12 may transfer the force to the mandible of the user.

[0049] The invention is described primarily in the context of the upper member 11 comprising the guide surface 14. In an alternative arrangement, the lower member 12 may comprise the guide surface 14. When the lower member 12 comprises the guide surface 14, then the sliding engagement transfers the forwards and upwards force between the guide surface 14 and the coupling 13. However, instead of the guide surface 14 applying the force onto the coupling 13, the coupling 13 applies the forwards and upwards force onto the guide surface 14 of the lower member 12. For brevity, the description focuses on the arrangement in which the upper member 11 comprises the guide surface 14, and the guide surface 14 applies the force to the coupling 13.

[0050] As shown in Figure 1, the upper member 11 may comprise the guide surface 14 to apply the forwards and upwards force on the coupling 13. The coupling 13 may be secured to the lower member 12 so as to transfer the forwards and upwards force to the lower member 12. In the alternative arrangement in which the lower member 12 comprises the guide surface 14, then the coupling 13 may be secured to the upper member 11. The guide surface 14 may receive the forwards and upwards force from the coupling 13.

[0051] Optionally, as shown in Figure 1 the coupling 13 is secured to the lower member 12 (or alternatively the upper member 11) so as to allow sideways movement of the lower member 12 relative to the upper member 11. This may help to increase the freedom of mandibular movement, which may make the MAD 10 more comfortable for the user. Although the MAD 10 may allow some sideways movement between the lower member 12 and the upper member 11, the MAD 10 may maintain the necessary corrections to the position of the mandible to reduce the possibility of airway obstruction.

[0052] For example, as shown in Figure 1, optionally the coupling 13 comprises a pivot 15. The pivot 15 is secured to the lower member 12 (or alternatively to the upper member 11) such that the coupling 13 is rotatable about the pivot 15 relative to the lower member 12 (or alternatively the upper member 11) to which it is secured. In the arrangement shown in Figure 1, the pivot 15 protrudes from the uplift arm 18 in the +X direction and the -X direction. This helps the pivot 15 to anchor the coupling 13 relative to the lower member 12.

[0053] As shown in Figure 1, the lower member 12 may comprise a cut-out portion 19. The cut-out portion 19 may be configured to accommodate part of the uplift arm 18 of the coupling 13. The cut-out portion 19 may be shaped such that forwards and backwards motion of the coupling 13 is limited. The cut-out portion 19 may substantially prevent any forwards or backwards motion of the coupling 13 relative to the lower member 12. This helps the coupling 13 to transfer the forwards force to the lower member 12. The pivot 15 of the coupling 13 may be longer in the X direction than part of the cut-out portion 19 that accommodates the uplift arm 18. Engagement between the lower member 12 and the pivot 15 may substantially prevent movement in the upwards or downwards direction of the coupling 13 relative to the lower member 12. This may help the coupling 13 to transfer the upwards force to the lower member 12.

[0054] As shown in Figure 1, the cut-out portion 19 may be substantially open in the sideways direction. This allows the coupling 13 to move sideways relative to the lower member 12. For example, when the coupling 13 rotates about the pivot 15, then the uplift arm 18 may move sideways out from or into the cut-out portion 19 of the lower member 12. The pivot 15 may extend along the X direction. The rotation of the coupling 13 may be about the X axis.

[0055] However, it is not essential for the fixation mechanism between the coupling 13 and the lower member 12 to allow sideways movement of the lower member 12 relative to the upper member 11. Figure 2 schematically shows an alternative way in which the upper member 11 may be coupled to the lower member 12. As shown in Figure 2, optionally the coupling 13 is substantially fixed relative to the lower member 12. The lower member 12 may comprise a clamp portion 25. The clamp portion 25 may substantially clamp the coupling 13 into a fixed position relative to the lower member 12. Undesirable sideways movement between the upper member 11 and the lower member 12 may be prevented.

[0056] As shown in Figure 1, optionally the guide surface 14 is concave. The guide surface 14 may be curved. The direction of the force may be substantially normal to the guide surface 14. By providing that the guide surface 14 is curved, the direction of the force applied by the MAD 10 on the mandible may vary depending on the position of the mandible. For example, as the mouth opens, the upwards portion of the force may increase. This may help the mandible to follow a biomimetic path. This can help to increase or maximise the tension of the hyoid bone and attached tongue muscles to clear the airway, irrespective of mouth openness.

[0057] As shown in Figure 1, optionally the guide surface 14 at least partly defines a groove 22 or depression in the upper member 11 (or alternatively the lower member 12) that comprises the guide surface 14. As shown in Figure 1, the groove 22 may be configured to limit the movement of the coupling 13, which in turn limits the movement of the lower member 12 and the mandible of the user. Engagement between the engagement member 16 of the coupling 13 and the walls (such as the guide surface 14) that define the groove 22 limits the movement of the lower member 12 relative to the upper member 11. As shown in Figure 1, the groove 22 may allow forwards and upwards movement of the lower member 12. The groove 22 may restrict only the most rearward and downwards positions of the lower member 12 relative to the upper member 11. The lower member 12 may be allowed to move within a range of motion corresponding to an unobstructed airway. Positions that would correspond to an obstructive airway are prevented by engagement between the guide surface 14 and the coupling 13. Optionally, the guide surface 14 is configured to limit the rearward position of the lower member 12 relative to the upper member 11. Optionally, the guide surface 14 is configured to limit the downward position of the lower member 12 relative to the upper member 11.

[0058] As shown in Figure 1, optionally the engagement member 16 of the coupling 13 has a convex exterior surface 17. The convex exterior surface 17 may help to make the sliding engagement between the engagement member 16 and the guide surface 14 more smooth. This may help to increase the comfort of the MAD 10 when it is worn by the user. As shown in Figure 1, optionally the engagement member 16 of the coupling 13 comprises a front exterior surface 171. The front exterior surface 171 may be convex. The front exterior surface 171 may be part of the convex exterior surface 17 of the engagement member 16. The front exterior surface 171 may face frontwards (i.e. in the +X direction).

[0059] As shown in Figure 1, optionally the engagement member 16 of the coupling 13 comprises a rear exterior surface 172. The rear exterior surface 172 may be convex. The rear exterior surface 172 may be part of the convex exterior surface 17 of the engagement member 16. The rear exterior surface 172 may face rearwards (i.e. in the -X direction).

[0060] As shown in Figure 1, optionally the guide surface 14 comprises a front curve 141. The front curve 141 may be at the front side (i.e. +X side) of the guide surface 14. The front curve 141 is an up-curling part of the guide surface 14. In use of the MAD 10, the front exterior surface 171 helps the coupling 13 to move upwards (i.e. in the +Z direction) along the front curve 141 of the guide surface 14. The engagement between the front exterior surface 171 and the front curve 141 of the guide surface 14 restricts the range of motion of the mandible.

[0061] As shown in Figure 1, optionally the guide surface 14 comprises a rear curve 142. The rear curve 142 may be at the rear side (i.e. -X side) of the guide surface 14. The rear curve 142 is an up-curling part of the guide surface 14. In use of the MAD 10, the rear exterior surface 172 helps the coupling 13 to move upwards (i.e. in the +Z direction) along the rear curve 142 of the guide surface 14. The engagement between the rear exterior surface 172 and the rear curve 142 of the guide surface 14 restricts the range of motion of the mandible.

[0062] Both the rear exterior surface 172 and the front exterior surface 171 act separately or in combination to result in the restricted range of motion of the mandible depicted in Figure 5, Figure 6, Figure 7, Figure 8 and Figure 9, for example. In use, the front exterior surface 171 acts against the front curve 141 in some situations, and the rear exterior surface 172 acts against the rear curve 142 in some situations. These two contacts happen sometimes together (while the coupling 13 is positioned on the bottom of the guide surface 14) and sometimes separately (if the coupling 13 is not on the bottom of the guide surface 14).

[0063] As shown in Figure 1, optionally the upper member 11 (or alternatively the lower member 12) that comprises the guide surface 14 further comprises a protector 20. The protector 20 is configured to reduce the possibility of (and optionally prevent) luxation of the coupling 13 from the upper member 11 (or alternatively the lower member 12) that comprises the guide surface 14. The protector 20 may help to make the MAD 10 more reliable in use.

[0064] As shown in Figure 1, optionally the protector 20 comprises a protective band. The protector 20 is configured to ensure secure positioning of the coupling 13 during mandibular movement, i.e. during use of the MAD 10. As shown in Figure 1, the protector 20 may be secured at two points to the upper member 11. Alternatively, the protector 20 may be secured at only one point to the upper member 11.

[0065] In the arrangement shown in Figure 1, the protector 20 is a thin band. In the alternative arrangement shown in Figure 2, the protector 20 forms a thicker band extending further in the Z direction.

[0066] The band of the protector 20 may be configured to extend around the coupling 13 such that the coupling 13 is located between the band and the upper member 11 (or alternatively the lower member 12) that comprises the guide surface 14.

[0067] As shown in Figure 2, optionally the coupling 13 comprises an L-shape. The coupling 13 may be configured to engage at one end with the guide surface 14 of the upper member 11 (or alternatively the lower member 12) that comprises the guide surface 14. The other end of the coupling 13 may be secured to the lower member 12 (or alternatively the upper member 11). The engagement between the engagement portion 16 (which may be referred to as a grabbing arm) and the guide surface 14 limits the range of motion of the mandible.

[0068] For example, as shown in Figure 2 the coupling 13 may comprise an uplift arm 18 and an advancement arm 21. The uplift arm 18 extends primarily in the Z direction. The advancement arm 21 extends primarily in the X direction. The uplift arm 18 and the advancement arm 21 may extend substantially perpendicularly to each other. Alternatively, the uplift arm 18 and the advancement arm 21 may be angled relative to each other, for example defining an acute angle or an obtuse angle between them. Optionally, the uplift arm 18 and the advancement arm 21 may be formed integrally. Alternatively, the uplift arm 18 and the advancement arm 21 may be formed as separate components that are subsequently assembled together.

[0069] However, it is not essential for the coupling 13 to comprise an L-shape. For example, as shown in Figure 1 the coupling 13 may comprise an uplift arm 18 but substantially no advancement arm 21. The advancement arm 21 may be provided so as to increase the extent of mandibular advancement promoted by the use of the MAD 10. As shown in Figure 2, the engagement portion 16 may be at the rearward end of the advancement arm 21. The uplift arm 18 may be at the forward end of the advancement arm 21. By providing a longer advancement arm 21, the advancement of the lower member 12 relative to the upper member 11 may be increased.

[0070] Optionally, the coupling 13 is comprised in a group of different couplings. Each of the different couplings can be interchangeably comprised in the MAD 10. That is, the MAD 10 comprises an interchangeable coupling system. One coupling may be exchanged for another. The different couplings 13 may have different dimensions. For example, different couplings 13 may have different lengths of advancement arm 21 and / or different lengths of uplift arm 18. The different couplings may correspond to different positions of the lower member 12 relative to the upper member 11 in the forwards direction and / or in the upwards direction. The coupling 13 may be selected so as to provide the desired advancement correction and the desired uplift correction.

[0071] Figure 3 schematically depicts engagement between an alternative coupling 13 and the guide surface 14. Compared to the coupling 13 shown in Figure 2, the coupling 13 shown in Figure 3 has substantially no advancement arm 21. The curved arrow within Figure 3 represents the path of mandibular advancement promoted by the MAD 10, i.e. through engagement between the guide surface 14 and the engagement member 16 of the coupling 13. The guided path is generally forwards and upwards relative to if the MAD 10 were not used.

[0072] Figure 4 schematically depicts a coupling 13 of the MAD 10. Optionally the coupling 13 is replaceable. For example, one coupling 13 may be replaced with a different coupling 13. As shown in Figure 4, the coupling 13 may comprise the uplift arm 18 and the advancement arm 21. The uplift arm 18 and the advancement arm 21 may form an L-shape. The couplings 13 may come in different lengths b of the uplift arm 18. The different couplings 13 may come in different lengths a of the advancement arm 21. A smaller length b of the uplift arm 18 may correspond to a generally greater uplift on the mandibular movement. A longer length a of the advancement arm 21 may correspond generally to a greater advancement of the mandible.

[0073] As shown in Figure 4, the engagement member 16 (with its concave exterior surface 17) and the uplift arm 18 may be provided at substantially opposite ends of the advancement arm 21 of the coupling 13. A physician may determine the desired level of uplift and / or advancement. The appropriate coupling 13 may be selected for assembly into the MAD 10.

[0074] Optionally, the MAD 10 is configured to apply the forwards and upwards force passively dependent on a position of the lower member 12 relative to the upper member 11. For example, the MAD 10 may be configured such that the lower member 12 is movable relative to the upper member 11 within a range within which the forwards and upwards force is not applied.

[0075] Figure 5 is a diagram showing the range of possible movement of the mandible when the MAD 10 has a coupling 13 with a first set of dimensions. The exact values of the dimensions mentioned herein are for demonstration purposes. The actual values / dimensions can be other values not specifically mentioned herein. The first set of dimensions are a length b of 18mm of the uplift arm 18, and no advancement arm 21 (i.e. length a = 0). In Figure 5, the nose points to the right, i.e. the right direction is the +X direction. The outline 54 corresponds to the shape of the guide surface 14. The area 50 shows the range of motion allowed for the mandible while the MAD 10 is equipped with the coupling 13 with the first set of dimensions. When the mandible is at the boundary of the allowed range of movement, then the MAD 10 applies the force on the mandible.

[0076] Figure 6 is a diagram showing the range of possible movement of the mandible when the MAD 10 has a coupling 13 with a second set of dimensions. The second set of dimensions are a length b of 18mm of the uplift arm 18, and a length a of 2mm of the advancement arm 21. The advancement further restricts the range of movement of the mandible compared to when no advancement arm 21 is present. The area 51 shows a range of movement that is not possible with the coupling 13 having the second set of dimensions but is possible with the coupling 13 having the first set of dimensions.

[0077] The MAD 10 may be configured to restrict vertical movement of the lower member 12 relative to the upper member 11 to a restricted range. Optionally, the restricted range decreases as the lower member 12 moves backwards relative to the upper member 11. This can be seen in Figure 6, for example, where the range of movement tapers towards the left. Optionally, the MAD 10 is configured to restrict a vertical position of the lower member 12 relative to the upper member 11 to a lowest vertical position. The lowest vertical position is the lower limit of the range of positions of the lower member 12 relative to the upper member 11. Optionally, the lowest vertical position is higher as the lower member 12 moves backwards relative to the upper member 11. This is shown in Figure 6, for example, where the bottom of the area 50 is higher towards the left of the area 50.

[0078] Figure 7 is a diagram showing the range of possible movement of the mandible when the MAD 10 has a coupling 13 with a third set of dimensions. The third set of dimensions are a length b of 18mm of the uplift arm 18, and a length a of 4mm of the advancement arm 21. The advancement further restricts the range of movement of the mandible compared to when no advancement arm 21 is present or a shorter advancement 21 is present. The area 51 shows a range of movement that is not possible with the coupling 13 having the third set of dimensions but is possible with the coupling 13 having the first set of dimensions.

[0079] Figure 8 is a diagram showing the range of possible movement of the mandible when the MAD 10 has a coupling 13 with a fourth set of dimensions. The fourth set of dimensions are a length b of 20mm of the uplift arm 18, and a length a of 2mm of the advancement arm 21. The uplift further restricts the range of movement of the mandible compared to when a smaller uplift is present. The area 51 shows a range of movement that is not possible with the coupling 13 having the fourth set of dimensions but is possible with the coupling 13 having the first set of dimensions.

[0080] Figure 9 is a diagram showing the range of possible movement of the mandible when the MAD 10 has a coupling 13 with a fifth set of dimensions. The fifth set of dimensions are a length b of 20mm of the uplift arm 18, and a length a of 4mm of the advancement arm 21. The uplift further restricts the range of movement of the mandible compared to when a smaller uplift is present. The area 51 shows a range of movement that is not possible with the coupling 13 having the fifth set of dimensions but is possible with the coupling 13 having the first set of dimensions.

[0081] The sets of dimensions are provided as examples only. Couplings 13 with different sets of dimensions may be used.

[0082] The invention concerns a dental splint and / or a MAD (10).

[0083] The MAD (10) comprising the upper member (11) and the lower member (12), while the upper member (11) and / or the lower member (12) is a dental splint according to the invention.

[0084] In other words, the invention concerns a dental splint as an upper member (11) or a lower member (12), and a MAD (10) comprising the upper member (11) and the lower member (12), while the upper member (11) and / or the lower member (12) is a dental splint according to the invention.

[0085] All features relative to the upper member (11) or the lower member (12) described hereafter are adaptable to the dental splint.

[0086] Figure 10 schematically depicts a plan view of a MAD (10) or a dental splint. Figure 10 shows the upper member 11 in plan view. As shown in Figure 10, the MAD or a dental splint comprises a CO2 sensor 30. The CO2 sensor 30 is configured to measure CO2 of exhaled and / or inhaled breath. For example, the CO2 sensor 30 may measure an intra-oral concentration of CO2 in the exhaled and / or inhaled breath. By measuring the CO2 in the exhaled and / or inhaled breath, the CO2 sensor 30 captures a more comprehensive data set. By measuring the CO2 in the exhaled and / or inhaled breath, it is easier for doctors to monitor the efficacy of the treatment when the user is using the MAD 10 or the dental splint.

[0087] In an embodiment the CO2 sensor 30 is configured to measure CO2 in inhaled breath. In another embodiment the CO2 sensor 30 is configured to measure CO2 in exhaled breath. The CO2 in the exhaled and / or inhaled breath serves as a direct indication of metabolism status of the patient. The CO2 sensor 30 may be configured to capture a comprehensive data set that includes both measurements of CO2 in inhaled breath and measurements of CO2 in exhaled breath. This allows the CO2 concentration in the inhaled breath to be compared to the concentration in the exhaled breath. This helps to improve the quality of information on which doctors may determine the efficacy of the treatment provided by use of the MAD 10 or the dental splint.

[0088] In contrast, without comparing the CO2 concentration between inhaled breath and exhaled breath, it is more difficult to determine the quality of the breathing of the user and the efficacy of the treatment.

[0089] Figure 11 is a graph showing the relationship between time and CO2 concentration. As shown in Figure 11, the CO2 level may be expected to rise and fall as the user breathes.

[0090] Figure 11 is an example showing the data that may be obtained by the CO2 sensor 30.

[0091] Optionally, the pattern of the CO2 level (e.g. the shape of the rise and fall) is analysed so as to determine a condition of the patient. During apnea, the CO2 level is not expected to change much in each breath cycle. In hypopnea, the exhaled CO2 level is smaller compared to during normal breathing.

[0092] Optionally, the CO2 sensor 30 is a thermal conductivity sensor. The CO2 sensor 30 may be configured to sense changes in the thermal conductivity of the breath so as to determine the concentration of CO2 in the breath. A thermal conductivity sensor is generally smaller than other types of CO2 sensor. A smaller CO2 sensor is more suitable for intra-oral use. The overall size of the MAD 10 or the dental splint may be reduced. The comfort of the user may be increased.

[0093] As shown in Figure 10, the CO2 sensor 30 is at least partly embedded into a member of the MAD 10 or the dental splint. For example, the arrangement shown in Figure 10 shows the CO2 sensor 30 embedded into the upper member 11. Additionally or alternatively, a CO2 sensor 30 may be at least partly embedded into the lower member 12 of the MAD 10 or the dental splint. By embedding the CO2 sensor 30, the CO2 sensor 30 may be protected by the member. For example, the CO2 sensor 30 may be at least partly protected from saliva in the mouth. By embedding the CO2 sensor 30, the CO2 sensor 30 may be provided to the MAD 10 or the dental splint without significantly increasing the overall volume of the MAD 10 or the dental splint. Improved data may be monitored during use of the MAD 10 or the dental splint without significantly reducing the comfort of the user. As shown in Figure 10, optionally the CO2 sensor 30 faces rearwards in use. The CO2 sensor 30 may face inwards into the mouth. The CO2 sensor 30 may be provided at an inward surface 24 of the upper member 11. By facing the CO2 sensor 30 rearwards in use, the CO2 sensor 30 may be better exposed to the breath within the mouth. The possibility of undesirably measuring the CO2 concentration of air outside the mouth may be reduced. As shown in Figure 10, the CO2 sensor 30 may be located at or near a concave surface, e.g. the inward surface 24, of the member (e.g. the upper member 11) of the MAD 10.

[0094] However, it is not essential for the CO2 sensor 30 to face rearwards in use. For example, in an alternative arrangement the CO2 sensor 30 may face sideways (e.g. along the Y-axis in Figure 10). The CO2 sensor 30 may be located at the inward surface 24 of the upper member 11 towards the back of the upper member 11. In an alternative arrangement, a plurality of CO2 sensors 30 may be provided. For example, there may be one CO2 sensor 30 facing rearwards and one or more CO2 sensors 30 facing sideways. The data from the plurality of CO2 sensors 30 may be combined, for example by averaging. This may improve the reliability of the measurements made by the CO2 sensor 30. Additionally or alternatively a CO2 sensor may be provided at or near an outward surface 23 of the upper member 11. The outward surface 23 is a generally forwards facing surface. The outward surface 23 is convex.

[0095] As shown in Figure 10, the MAD 10 or the dental splint comprises a membrane 31. The membrane 31 is a protective membrane. The membrane 31 preferably cover the CO2 sensor 30. Optionally the membrane 31 is configured to protect the CO2 sensor 30. For example the membrane 31 protects the CO2 sensor 30 from saliva. The membrane 31 is preferably substantially impermeable to liquids such as saliva. The membrane 31 is preferably hydrophobic and / The membrane 31 is permeable to gas. The membrane 31 allows the inhaled and / or exhaled breath to pass through the membrane 31 so as to reach the CO2 sensor 30. The membrane 31 may reduce the possibility of the CO2 sensor 30 undesirably degrading in quality or being damaged. The lifetime of the CO2 sensor 30 and / or the MAD 10 or the dental splint may be lengthened.

[0096] Optionally, substantially the only surface of the CO2 sensor 30 that is exposed to the interior of the mouth is the active surface of the CO2 sensor 30. The active surface of the CO2 sensor 30 is the surface that receives the gas that is to be measured. The active surface interacts with the gas so as to measure the CO2 concentration. The active surface of the CO2 sensor 30 may be protected by the membrane 31.

[0097] Optionally, the MAD 10 or the dental splint comprises a protecting cage, working in tandem with the liquid protection membrane 31 and / or mesh that prevents the tongue from touching the sensing window's membrane and / or the mesh. The sensing window's membrane corresponds to the active surface of the CO2 sensor 30. The protecting cage comprises holes, preferably in different sizes so that the tongue can never block all the holes, therefore there will always be gas exchange with the sensing window.

[0098] According to one embodiment, not shown, the CO2 sensor 30 is surrounded by a frame while the frame is embedded within the protecting cage. The membrane 31 is located between the frame of the CO2 sensor 30 and the protecting cage. More precisely, the membrane 31 is glued to the sensor side of the protecting cage. The membrane 31 is thus glued between the frame and the protecting cage to seal the sensors and to only let air pass through the membrane 31.

[0099] According to another embodiment, not shown, the CO2 sensor 30 is surrounded by a frame while the frame is embedded within the protecting cage, while the membrane 31 is directly glued to the sensor side of the protecting cage, without being located between the frame and the protected cage.

[0100] A suitable example of the membrane 31 can be a hydrophobic and oleophobic surface treated microporous acrylic copolymer membrane cast on a non-woven nylon support.

[0101] Alternatively, microporous PTFE, PVDF, PP, PE, PES, PC, TPU, etc may also be used with hydrophobic and oleophobic surface treatment.

[0102] It is understood that the membrane 31 according to the invention is an independent membrane part of the MAD or the dental splint and not a membrane protecting the active surface of the CO2 sensor made by the manufacturer of the CO2 sensor.

[0103] In other words, the tongue-guard protecting cage and the hydrophobic, gas-permeable membrane 31 are positioned over the gas-sensing interface of the CO2 sensor 30 to permit gas and water-vapor exchange while blocking saliva and liquid ingress and preventing direct contact during use.

[0104] The sensors are embedded within the structure of the dental splint so as to ensure comfort, fit, and safety during prolonged use in both active and resting states. Anchoring the device to the teeth provides rigid coupling to cranial motion, enabling high-fidelity headmechanics measurement independent of soft tissue movement. The splint communicates with a data processing unit configured to collect, transmit, and analyze the recorded data in real time or offline, including the coupling between mechanical head stability and ventilatory / metabolic indicators.

[0105] By enabling continuous and combined measurement of biomechanical and physiological parameters with protected intraoral gas sensing, through a single intraoral device, the system provides a comprehensive assessment of an athlete’s physical performance, recovery quality, and overall physiological state without interfering with activity or sleep.

[0106] As shown in Figure 10, optionally the MAD 10 or the dental splint comprises a pressure sensor 36. The pressure sensor 36 is configured to measure pressure of the inhaled breath and / or exhaled breath in the mouth. The pressure sensor 36 may be embedded in the MAD 10 or the dental splint, for example in the upper member 11. The pressure sensor 36 may be exposed only at its active surface. The active surface may be protected by the membrane 31. Alternatively, a separate membrane may be provided to protect the pressure sensor 36. The pressure sensor 36 may be provided at the inward surface 24 of the upper member 11 or the lower member 12. Alternatively, the pressure sensor 36 may be provided at the outward surface 23 of the upper member 11 or the lower member 12. As shown in Figure 10, optionally the MAD 10 or the dental splint comprises a temperature sensor 37. The temperature sensor 37 is configured to measure a temperature of the inhaled breath and / or exhaled breath in the mouth. The temperature sensor 37 may be embedded in a member of the MAD 10 or the dental splint. For example, the temperature sensor 37 may be embedded in the upper member 11. The temperature sensor 37 may be exposed substantially only at its active surface. The active surface of the temperature sensor 37 may be protected by the membrane 31.

[0107] Alternatively a separate membrane may be provided to protect the temperature sensor 37. The temperature sensor 37 may be provided at the inward surface 24 of the upper member 11 or the lower member 12. Alternatively, the temperature sensor 37 may be provided at the outward surface 23 of the upper member 11 or the lower member 12.

[0108] As shown in Figure 10, optionally the MAD 10 or the dental splint comprises a humidity sensor 38. The humidity sensor 38 is configured to measure a humidity of the inhaled breath and / or exhaled breath in the mouth. Optionally the humidity sensor 38 is at least partly embedded in a member of the MAD 10 or the dental splint. For example, as shown in Figure 10 the humidity sensor 38 is at least partly embedded in the upper member 11 of the MAD 10 or the dental splint. The humidity sensor 38 may be exposed substantially only at its active surface. The active surface of the humidity sensor 38 may be protected by the membrane 31. Alternatively, a separate membrane may be provided to cover the active surface of the humidity sensor 38. The humidity sensor 38 may be provided at the inward surface 24 of the upper member 11 or the lower member 12. Alternatively, the humidity sensor 38 may be provided at the outward surface 23 of the upper member 11 or the lower member 12. Optionally the MAD 10 or the dental splint comprises a sensor configured to sense motion of the mandible. For example the sensor may comprise an accelerometer, a gyroscope, a magnetic sensor or a motion sensor. As another example, the sensor may comprise a magnetic sensor and a magnet on opposing parts of the MAD 10. For example, the upper member 11 may comprise a magnetic sensor configured to sense a change of magnetic field indicative of movement of a magnet of the lower member 12. Alternatively, the lower member 12 may comprise a magnetic sensor configured to sense a change of magnetic field indicative of movement of a magnet of the upper member 11. The relative motion of the mandible can then be detected by the change in magnetic field.

[0109] Optionally, the MAD 10 or the dental splint comprises a microphone.

[0110] Optionally the MAD 10 or the dental splint comprises a noise detector. The noise detector may make it easier to analyse breaths and / or detect different abnormal sleep events.

[0111] By providing further sensors such as the pressure sensor 36, the temperature sensor 37, the humidity sensor 38, the sensor for sensing motion of the mandible and / or the noise detector, further data from the user may be obtained. A more comprehensive profile of the breathing pattern of the user may be obtained.

[0112] For example, the MAD 10 or the dental splint may be configured to measure the CO2 concentration, pressure, temperature and / or humidity of the inhaled breath and / or exhaled breath of the user during sleep. The MAD 10 or the dental splint may measure changes in intra-oral CO2 concentration, for example, and breathing patterns. The residual apneas or hypopneas under treatment can be more precisely assessed. This can help to allow the efficiency of the treatment to be monitored. By monitoring the CO2 concentration variation, it may be easier to determine how many hours each night and for how many nights the MAD 10 is worn by the user. This may help to assess the efficacy of the treatment.

[0113] Alternatively, by monitoring the CO2 concentration variation by the dental splint, during sport activities, it may be easier to determine performance.

[0114] The dental splint integrating both biomechanical and physiological sensors introduces a novel approach to sport performance and recovery monitoring. By embedding multiple sensing modalities within a single intraoral device, it achieves a level of accuracy, comfort, and continuity not possible with conventional wearables.

[0115] From a technical standpoint, the system enables simultaneous measurement of mechanical and physiological parameters such as impact forces, mandibular motion, heart rate, respiration, and temperature. The intraoral position ensures high signal stability and minimal motion artifacts, even during intense physical activity. The same device can be used both during sports and sleep, providing continuous 24-hour data on performance and recovery dynamics. Its ergonomic design and wireless connectivity ensure user comfort, compliance, and real-time data transmission.

[0116] The dental splint according to the invention thus relates to a system and an intraoral dental splint designed to enable combined measurement of biomechanical and physiological parameters in athletes during both sports activity and recovery phases, including sleep. The dental splint comprises one or more biomechanical sensors configured to detect parameters such as acceleration, impact forces, mandibular motion, clenching force and posture, and one or more physiological sensors configured to measure parameters including respiratory activity (ventilatory / metabolic signals with CO2 / O2 proxies), cardiorespiratory indicators (HR, HRV, SpO2), body temperature, saliva composition or other vital signs.

[0117] The measurement of the CO2 level can help to provide information about possible hypoventilation during sleep with higher accuracy than sensors that need to be placed external to the user.

[0118] As shown in Figure 1, optionally the MAD 10 or the dental splint comprises a transmitter 33. The transmitter 33 is configured to transmit wirelessly measurements measured by the CO2 sensor 30. When the MAD 10 comprises alternative or additional sensors such as the pressure sensor 36, temperature sensor 37 and / or humidity sensor 38, the transmitter 33 may be configured to wirelessly transmit measurements measured by the one or more other sensors. For example, the transmitter 33 may be configured to transmit data to an external device. The external device may be connected wirelessly to the MAD 10 or the dental splint. For example, the external device may be connected directly, for example through short-range wireless technology (e.g. Bluetooth) or nearfield communication. The external device may be connected to the MAD 10 or the dental splint via a network. The external device may be, for example, a smart phone or a monitoring hub.

[0119] It is not essential for the MAD 10 or the dental splint to be provided with a transmitter 33. For example, optionally the MAD 10 or the dental splint comprises a memory. The memory may be configured to store measurements made by one or more of the sensors comprised in the MAD 10 or the dental splint. For example, the measurements made by the CO2 sensor 30 may be stored locally in the memory. Use of the memory means that the user may not be exposed to the communication signals while wearing the MAD 10 or the dental splint. Storing the data locally and subsequently transferring the data may allow for more reliable data transfer compared to transferring the data while the user is wearing the MAD 10 or the dental splint. For example, the head of the user could be in the way of the data transfer. The MAD 10 or the dental splint may subsequently be physically connected to an external device so as to share the measurements via a physical connection. Optionally, the MAD 10 or the dental splint comprises both a memory and the transmitter 33. The MAD 10 or the dental splint may both store data locally and transmit the data wirelessly.

[0120] As shown in Figure 1, optionally the MAD 10 or the dental splint comprises a processor 34. The processor 34 may be configured to process measurements measured by the CO2 sensor 30. For example, the processor 34 may be configured to process the measurements so as to distinguish between the inhaled breath and the exhaled breath. The processor 34 may be configured to determine the efficacy of the treatment of a sleep breathing disorder (e.g. sleep apnea) based on the measurements made by the CO2 sensor 30, the pressure sensor 36, the temperature sensor 37 and / or the humidity sensor 38. The processor 34 may be configured to determine the apnea-hypopnea index, which is a metric used to diagnose and assess sleep apnea severity. Optionally, the processor 34 is configured to perform an Al assisted analysis with a neural network. Alternatively, data processing including an Al assisted analysis with a neural network may be performed by a device remote from the MAD 10 or the dental splint.

[0121] The processor 34 may be configured to control the transmitter 33 to transmit data to an external device. For example, the processor 34 may be configured to control the transmitter 33 to transmit the data periodically, for example hourly or daily. The processor 34 may be configured to control the transmitter 33 to transmit the data in response to a request received from an external device. Alternatively, the processor 34 may be omitted.

[0122] As shown in Figure 1, optionally the MAD 10 and by extension the dental splint comprises a power source 35. The power source 35 may be configured to provide electrical power to one or more components of the MAD 10 or the dental splint. For example, the power source 35 may be configured to provide power to the CO2 sensor 30, the pressure sensor 36, the temperature sensor 37, the humidity sensor 38, the transmitter 33 and / or the processor 34. Optionally, the power source 35 is rechargeable. For example, the power source 35 may be configured to charge wirelessly. The power source 35 may be a battery. The power source 35 may allow substantially continuous operation of the MAD 10 or the dental splint including its sensors without removal of the MAD 10 or the dental splint from the user. Alternatively, an external power source may provide power to the MAD 10 or the dental splint.

[0123] As shown in Figure 1, optionally the transmitter 33, the processor 34 and / or the power source 35 is integrated into the MAD 10 and by extension into the dental splint. For example, Figure 1 shows the transmitter 33, the processor 34 and the power source 35 integrated into, for example embedded in, the upper member 11. In an alternative arrangement, the transmitter 33, the processor 34 and / or the power source 35 may be integrated into, for example embedded in, the lower member 12.

[0124] As shown in Figure 1, optionally the transmitter 33, the processor 34 and / or the power source 35 is provided at or near a forward facing surface of the MAD 10. For example, the surface may be the convex outward surface 23 at the front of the upper member 11.

[0125] As shown in Figure 1 and Figure 10, optionally the MAD 10 or the dental splint comprises at least one electrical connector 32. The electrical connector 32 is configured to electrically connect different electrical components of the MAD 10 or the dental splint. The electrical connector 32 may be configured to transfer power and / or data between the electrical components. For example, the electrical connector 32 may transfer power from the power source 35 to the CO2 sensor 30. The electrical connector 32 may transfer data from the CO2 sensor 30 (and optionally one or more other sensors) to the transmitter 33. Optionally, the electrical connector 32 is embedded in a member such as the upper member 11 so as to protect the electrical connector 32.

[0126] Figure 12 schematically depicts a MAD 10. Features of the MAD 10 may be the same as described with reference to Figure 1 and Figure 10, for example. As shown in Figure 12, optionally the MAD 10 and by extension the dental splint comprises a detachable sensor member 56. The sensor member 56 may be detached from and attached to the rest of the MAD 10 or the dental splint. For example, the sensor member 56 may be attachable to the upper member 11. The upper member 11 may comprise a base member 55. Once attached, the sensor member 56 may form part of the upper member 11. The upper member 11 comprises the base member 55 and the sensor member 56. As another example, the sensor member 56 may be attachable to the lower member 12. The lower member 12 may comprise a base member. Once attached, the sensor member 56 may form part of the lower member 12. The lower member 12 may comprise the base member and the sensor member 56.

[0127] The sensor member 56 may comprise one or more components for taking measurements. As shown in Figure 12, optionally the sensor member 56 comprises one or more of the CO2 sensor 30, the transmitter 33, the processor 34, the power source 35, the pressure sensor 36, the temperature sensor 37 and the humidity sensor 38.

[0128] When it is not necessary to take measurements, the MAD 10 may be worn without the sensor member 56 attached. The base member 55 forms the upper member 11. Optionally, the sensor member 56 can be clipped onto the rest of the MAD 10. The sensor member 56 can then be used to take measurements, for example to help determine the efficacy of the treatment of a sleep breathing disorder. The sensor member 56 can be attached to the base member 55 of the MAD 10 when the doctor wants to assess the effectiveness of the treatment, for example when a change in the advancement (e.g. the type of coupling 13) is made.

[0129] The sensor member 56 may be used (i.e. attached to) a plurality of different MADs 10. The MAD 10 without the sensor member can be replaced without having to replace the sensor member 56. The cost of manufacturing or replacing the MAD 10 without the sensor member 56 may be lower than manufacturing or replacing the MAD 10 with the sensors permanently embedded.

[0130] Optionally, the base member 55 and the sensor member 56 comprise complementary engagement members configured to engage with each other so as to lock the sensor member 56 to the base member 55. The sensor member 56 and the MAD 10 or the dental splint without the sensor member 56 may be bought and sold separately.

[0131] Optionally the sensor member 56 comprises a sensor configured to sense motion of the mandible. For example the sensor may comprise an accelerometer or a motion sensor. As another example, the sensor may comprise a magnetic sensor and a magnet on opposing parts of the MAD 10. For example, the sensor member 56 of the upper member 11 may comprise a magnetic sensor configured to sense a change of magnetic field indicative of movement of a magnet of the lower member 12. The relative motion of the mandible can then be detected by the change in magnetic field. Alternatively, when the sensor member 56 is part of the lower member 12, then the upper member 11 may comprise a magnet. The relative motion of the mandible can then be detected by the change in magnetic field.

[0132] By sensing the motion of the mandible, movements of the mandible may be assessed. Such movements may be correlated to respiratory effort. The respiratory effort may be determined based on the measurements by the sensor. The difference between central and obstructive sleep apnea may be determined based on the respiratory effort. For example, central sleep apnea may be correlated to substantially no respiratory effort, while obstructive sleep apnea may be correlated to high effort.

[0133] Optionally the sensor member 56 comprises a photoplethysmogram sensor (PPG sensor) which conventionally comprises a pulse oximeter which monitors the perfusion of blood to the dermis and subcutaneous tissue of the skin, that can be used to detect blood volume changes in the microvascular bed of tissue.

[0134] Figure 13 depicts an exemplary display 40 on an external device connected to the MAD 10. As shown in Figure 13, the display 40 may comprise a graph 41 showing the relationship between time and one or more measured parameters. For example, the graph 47 shown in Figure 13 shows the variation of CO2 concentration and the variation of pressure over time. As shown in Figure 13, optionally the display 41 indicates the instantaneous values of the measured parameters. For example, there may be an instantaneous CO2 concentration field 42, an instantaneous pressure field 43, an instantaneous temperature field 44 and / or an instantaneous humidity field 45. Optionally, the MAD 10 measures and provides live data corresponding to the measurements made by the one or more sensors of the MAD 10.

[0135] Optionally the MAD 10 comprises a memory for storing the data.

[0136] As shown in Figure 13, optionally the display 40 comprises a MAD field 46 indicating the MAD 10 to which the external device is connected. For example, the MAD field 46 may indicate the name of the MAD 10 and / or an ID of the MAD 10. Optionally the display 40 comprises a connection status field 47 that indicates whether or not the external devices currently connected to the MAD 10.

[0137] As shown in Figure 13, optionally the display 40 comprises a connection button 48. When a user presses the connection button 48, the external device may initiate a procedure for connecting to a MAD 10. As shown in Figure 13, optionally the display 40 comprises a data export button 49. When a user presses the data export button 49, a process for initiating export of data (e.g. the measurements made) to another device may be initiated.

[0138] Figure 14 is a schematic flow chart of a method of manufacturing the MAD 10. As shown in Figure 14, optionally the method of manufacturing the MAD 10 comprises a step of scanning 81 the dental profile of the user. The scan may be a 3D scan, for example.

[0139] However, it may not be necessary to perform the scan of the dental profile. For example, the dental profile of the user may already be known. Alternatively, the MAD 10 may be manufactured without knowing the dental profile of the user. By 3D scanning the dental profile of the user, the MAD 10 may be fully customised and designed based on the dental profile of the user. This may help to increase the comfort of the user when wearing the MAD 10. This may also help to increase retainability on the teeth.

[0140] As shown in Figure 14, optionally the method of manufacturing the MAD 10 comprises 3D printing 82 the upper member 11 and the lower member 12. For example, the upper member 11 and the lower member 12 may be 3D printed based on the dental profile of the user. However, it is not essential for the upper member 11 and the lower member 12 to be 3D printed. The upper member 11 and the lower member 12 may be manufactured by other means, for example using a mold.

[0141] Optionally the upper member 11 and / or the lower member 12 comprises a plurality of layers. For example, an inner layer may be provided for engaging with the teeth of the user. An outer layer may be provided to form an outward-facing surface. Optionally, the inner layer is softer than the outer layer. By providing a softer inner layer, the MAD may be more comfortable for the user to wear. Br providing that the outer layer is harder, retainability on the teeth may be improved. The possibility of the MAD undesirably being dislodged from the teeth, for example during opening of the mouth, may be reduced. Optionally, the upper member 11 and / or the lower member 12 is formed from at least one resin. Optionally, different resins are used for the different layers.

[0142] As shown in Figure 14, optionally the method for manufacturing the MAD 10 comprises a step of selecting 83 a coupling 13. For example, the coupling 13 may be selected based on the specified desired advancement and uplift to be provided by the MAD 10. The advancement and uplift may be specified by a physician, for example. The coupling 13 may be selected based on the dimensions of the uplift arm 18 and / or the advancement arm 21 of the coupling 13, for example. The coupling 13 may be selected based on measurements from sensors such as the CO2 sensor 30 made during previous use of a MAD 10 by the patient, As shown in Figure 14, optionally the method for manufacturing the MAD 10 comprises the step of assembling 84 the MAD 10. For example, the coupling 13 may connect the upper member 11 to the lower member 12. The pivot 15 of the coupling 13 may be fixed into the cut-out portion 19 of the lower member 12. The engagement member 16 of the coupling 13 may be located within the groove 22 defined by the guide surface 14. The protector 20 may be positioned so as to retain the coupling 13.

[0143] Optionally, a method of manufacturing the MAD 10 may comprise replacing the coupling 13 with an alternative coupling 13. The alternative coupling 13 may have different dimensions, for example an uplift arm 18 of a different length and / or an advancement arm 21 of a different length.

[0144] Figure 15 is a flow chart of optional features of manufacturing the MAD 10. As shown in Figure 15, optionally the method for manufacturing the MAD 10 comprises embedding 91 the CO2 sensor 30 into the upper member 11 (or alternatively into the lower member 12). For example, when the upper member 11 is 3D printed, a space may be provided to accommodate the CO2 sensor 30. The CO2 sensor 30 may be pressed into the space.

[0145] As shown in Figure 15, optionally the method for manufacturing the MAD 10 comprises embedding 92 one or more of a pressure sensor 36, a temperature sensor 37 and a humidity sensor 38 into the upper member 11 (or optionally into the lower member 12). For example, when the upper member 11 is 3D printed, spaces may be provided for accommodating the other sensors. As shown in Figure 15, optionally the method for manufacturing the MAD 10 comprises covering 93 the sensors with the membrane 31. For example, at least the active surface of one or more of the CO2 sensor 30, the pressure sensor 36, the temperature sensor 37 and the humidity sensor 38 may be protected by the membrane 31. The membrane 31 may be applied after the sensor has been embedded into the upper member 11.

[0146] As shown in Figure 15, optionally the method for manufacturing the MAD 10 comprises embedding 94 one or more of an electrical connector 32, a power source 35, a processor 34 and a transmitter 33 into the upper member 11 (or optionally the lower member 12).

[0147] It is not essential for the steps shown in Figure 14 or Figure 15 to be performed in the order shown in the Figures. For example, the electrical connector 32, power source 35, processor 34 and / or transmitter 33 may be embedded before any of the sensors are embedded. As a further example, the coupling 13 may be selected before the upper member 11 and the lower member 12 are manufactured (e.g. 3D printed).

Claims

CLAIMS1. A dental splint comprising:a carbon dioxide sensor (30) preferably configured to measure carbon dioxide of exhaled and / or inhaled breath,wherein the carbon dioxide sensor (30) is at least partly embedded into the dental splint, andwherein the dental splint comprises a membrane (31) covering the carbon dioxide sensor and configured to protect the carbon dioxide sensor from saliva.

2. The dental splint of claim 1, wherein the active surface of the carbon dioxide sensor (30) is protected by the membrane (31).

3. The dental splint of claim 1 or 2, wherein the membrane (31) is substantially impermeable to liquids and permeable to gas.

4. The dental splint of any of the preceding claims, comprising a protective cage and / or a mesh that prevents the tongue from blocking the sensing window's membrane (31).

5. The dental splint of any of the preceding claims, wherein the carbon dioxide sensor (30) is a thermal conductivity sensor,6. The dental splint of any of the preceding claims, wherein the carbon dioxide sensor faces rearwards in use.

7. The dental splint of any of the preceding claims, comprising at least one of a pressure sensor (36), a temperature sensor (37), a humidity sensor (38), a sensor for sensing motion of the mandible, a gyroscope, an accelerometer, photoplethysmogram sensor, a microphone and a noise detector (31).

8. The dental splint of any of the preceding claims, comprising a transmitter (33) configured to transmit wirelessly measurements measured by the carbon dioxide sensor (30); and / orcomprising a memory configured to store measurements measured by the carbon dioxide sensor;, and comprising a processor configured to process measurements measured by the carbon dioxide sensor (30).

9. The dental splint of any of the preceding claims, comprising a detachable sensor member (56) comprising the carbon dioxide sensor (30).

10. The dental splint of the preceding claim, comprising a base member (55) and wherein the sensor member (56) comprises complementary engagement members configured to engage with each other so as to lock the sensor member (56) to the base member (55).

11. A mandibular advancement device MAD (10), comprising an upper member (11) and a lower member (12) wherein the dental splint according to any of the preceding claims, is the upper member (11) and / or the lower member (12).

12. The MAD (10) of the preceding claim, wherein the detachable sensor member (56) according to claim 9 or 10, comprises a magnetic sensor and a magnet on opposing parts of the MAD (10) to detect movements correlated to respiratory effort.

13. A mandibular advancement device, MAD (10), configured to adjust a position of a mandible of a user wearing the MAD (10), wherein the MAD (10) comprises:a base member (55) configured to adapt to a maxilla of the user; and a lower member (12) configured to adapt to the mandible;wherein the base member (55) comprises an engagement member configured to engage with a complementary engagement member of a detachable sensor member (56) that comprises a carbon dioxide sensor (30) so as to lock the detachable sensor member to the base member (55).

14. A detachable sensor member (56) for a mandibular advancement device, MAD (10), configured to adjust a position of a mandible of a user wearing the MAD (10) according to claim 11 or 12, wherein the detachable sensor member (56)comprises:a carbon dioxide sensor (30) configured to measure carbon dioxide; andan engagement member configured to engage with a complementary engagement member of a base member (55) of the MAD (10) so as to lock the sensor member to the base member (55).

15. The detachable sensor member of claim 14, comprising at least one of a pressure sensor, a temperature sensor, a humidity sensor, a sensor for sensing motion of the mandible, a gyroscope, an accelerometer, photoplethysmogram sensor, a microphone, a noise detector and a memory configured to store measurements measured by the carbon dioxide sensor.

16. A method for manufacturing a mandibular advancement device, MAD (10), configured to adjust a position of a mandible of a user wearing the MAD (10) according to any of the claims 1 to 11, wherein the method comprises:providing a carbon dioxide sensor (30) configured to measure carbon dioxide of exhaled and / or inhaled breath;attaching a detachable sensor member (56) that comprises the carbon dioxide sensor (30) and an engagement member to a complementary engagement member of a base member (55) of the MAD (10) so as to lock the detachable sensor member (56) to the base member (55).

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