Technique for manufacturing a customized smart dental device and customized smart dental device

Abstract

The invention relates to manufacturing a customized smart dental device (600). A skirt portion digital data set may be used in the manufacturing. The skirt portion (200) tightly fits a person's facial, lingual and / or occlusal dental surface topology. The skirt portion digital data set defines an inner surface contour. The skirt portion digital data set further defines an outer surface contour of the skirt portion, which comprises one or more mounting surface portions (216) for mounting electronic components (630-1; 630-2; 630-3). The outer surface contour of the skirt portion (400) defines a skirt-side sealing structure (218) configured to engage sealingly with a mould-side sealing structure of a mould portion (400). The skirt-side sealing structure defines a boundary line of a mould cavity formed.

Description

[0001] Technique for Manufacturing a Customized Smart Dental Device and Customized Smart Dental Device

[0002] Field of the Invention

[0003] The present invention relates to a technique for manufacturing a customized smart dental device as well as a customized smart dental device (e.g., a dental treatment device such as a splint). In particular, a skirt portion digital data set for use in manufacturing of a skirt portion of a customized smart dental device, a skirt portion of the customized smart dental device, a mould portion digital data set for use in manufacturing of a mould portion for manufacturing a customized smart dental device, a mould portion for use in manufacturing of a mould portion for manufacturing a customized smart dental device, a method of manufacturing the customized smart dental device and the customized smart dental device are provided.

[0004] Background of the Invention

[0005] Bruxism is a frequent condition with about 8% to 12% of the population displaying a repetitive jaw-muscle activity such as clenching or grinding their teeth during their sleep, and even more than 20% in an awake state.

[0006] Oral appliances, such as dental splints for bruxism treatment, are known in the art. For example, a Michigan splint is an example of an oral appliance that covers the occlusal surface of all teeth in either the maxilla (upper jaw) or mandible (lower jaw) and is therefore termed a “full-coverage splint”. These types of appliances are generally customized to a patient’s dental surfaces and are thus defined by a unique and highly detailed topology. They are typically manufactured from a hard resin such as poly-methyl-methacrylate or the like.

[0007] However, unfortunately, patient compliance with appliances, such as, for example, retainers, dental splints or night guards is sometimes sketchy and it is assumed that better monitoring combined with active engagement with a patient might improve compliance with retainers, bitesplints or sleep appliances. In addition, it would be desired to obtain additional information, such as, for example, an improved insight into a patient’s usage pattern, treatment progress, or other physiological data while using such appliances.

[0008] There have been attempts to design customized as well standardized monitoring appliances for use by patients, however, these known appliances have often been bulky and, hence, not comfortable enough to achieve sufficient compliance. In addition, many known devices have proven to exhibit insufficient resistance to wear or complex to manufacture.

[0009] There is thus a need for an improved dental appliance, such as a smart dental device customized to a person’s dental surface topology allowing to overcome at least some of the disadvantages of known dental appliances. Particularly, there is a need for an improved dental appliance that allows for an improved monitoring and / or treatment. Particularly, there is a need an improved dental appliance that is customized to its user and thus exhibits an improved wearing comfort to enhance, amongst other things, on the patient monitoring and compliance. Moreover, there is a need for improved manufacturing techniques to allow producing dental appliances having improved lifetimes and resistance against wear.

[0010] Summary

[0011] This object is solved at least in part by a skirt portion digital data set for use in manufacturing of a skirt portion of a customized smart dental device according to claim 1, a skirt portion according to claim 11, a method for manufacturing a skirt portion according to claim 12, a mould portion digital data set for use in manufacturing of a mould portion for manufacturing a customized smart dental device according to claim 17, a mould portion according to claim 21, a method for manufacturing a mould portion for manufacturing of a customized smart dental device according to claim 22, a method for manufacturing of a customized smart dental device according to claim 26 and a smart dental device according to claim 33. Aspects, features and embodiments are described in the dependent claims and in the following description together with advantages.

[0012] In the following, the solution according to the invention is described with respect to the claimed skirt portion digital data set, the claimed mould portion digital data set, the skirt portion, the mould portion, the customized smart dental device, the method for manufacturing the skirt portion, the method for manufacturing the mould portion, as well as with respect to the method for manufacturing a smart dental device. Features, advantages or alternative embodiments herein can be assigned to the other claimed objects (e.g., the skirt portion, the mould portion, and / or the smart dental device), and vice versa.

[0013] In other words, the skirt portion, the mould portion, and / or the smart dental device can be improved with features described or claimed in conjunction with the corresponding manufacturing method, and vice versa. In this case, the functional features of the method are embodied by structural elements of the skirt portion, the mould portion, and / orthe smart dental device and vice versa, respectively. Likewise, features described in conjunction with the device or it’s wearer, such as, anatomical orientations, or method steps, should be understood to also refer to the corresponding definitions of the surface portions of the corresponding digital data sets, and vice versa. In particular, as an example, a reference to the digital definition of a surface shall also serve as a reference to the physical surface, once a manufacturing of the device has occurred according to the digital definition, and vice versa.

[0014] In a first aspect of the invention, a skirt portion digital data set for use in manufacturing of a skirt portion of a customized smart dental device is provided. The skirt portion tightly (or snuggly) fits at least a facial, lingual and / or occlusal dental surface topology of a person. The skirt portion digital data set defines an inner surface contour of the skirt portion customized to match (or matching) the facial, lingual and / or occlusal dental surface topology, i.e., the inner surface contour defines a surface facing an occlusal surface, a surface facing a facial surface and a surface facing a lingual surface of the dental topology of the person. The inner surface contour is configured to form an inner surface of the skirt portion.

[0015] The skirt portion digital data set further defines an outer surface contour of the skirt portion. The outer contour comprises one or more mounting surface portions for mounting at least one electronic component. The outer surface contour of the skirt portion defines at least one skirt-side sealing structure configured to engage sealingly with a mould-side sealing structure of a mould portion. The skirt-side sealing structure defines a boundary line of a mould cavity defined by at least a part of the outer surface contour of the skirt portion as a portion of the inner mould cavity contour.

[0016] Using the technique of the invention, comprising the skirt portion digital data set of the first aspect, a mould portion digital data set, a customized skirt portion and a customized mould portion, a customized smart dental device (also: oral appliance, and / or optionally a dental treatment device, such as a splint, guard, retainer or brace) may be manufactured with very high precision and in a time-efficient manner.

[0017] The skirt portion digital data set may be embodied on a transient or non-transient storage medium or on a carrier wave in a packeted form, such as, for example, in TCP / IP packets or as a stream, such as, for example, a UDP stream.

[0018] In the context of the present disclosure, "customized" denotes the smart dental device being manufactured so as to be fitted to the person's specific anatomy, in particular, the person's dentition and / or dental surface topology, such as to his / her maxilla, mandible and / or their occlusal surfaces (also: masticatory surface or chewing surfaces) at high precision.

[0019] The customized smart dental device may, for example, be a bruxism splint (and / or smart bitesplint), or a smart retainer, such as to increase compliance of orthodontic treatments and / orto improve treatment with sensory components, such as tooth force measurements. A customized smart dental device used as a sleep appliance may have sensory components that are usable for compliance monitoring, respiratory monitoring, and / or other health status information gathering. For example, for bruxism treatment, persons may benefit from high-quality (in particular, customized) Michigan-type bite-splints with bruxism monitoring and optional biofeedback to actively reduce the bruxism activity.

[0020] Using the technique of the invention, a smart dental device may be produced where a substantial subtractive removal of material can be avoided. By the mould cavity being formed by the mould portion and the skirt portion, when mounted to one another, an outer occlusal surface of the smart dental device matching an opposition occlusal dental surface topology of the person may be obtained (essentially directly) from the moulding / fil ling process. Alternatively, or in addition, only fine adjustments may need to be performed, such as, for example, by a dentist or dental technician when finishing fitting the customized smart dental device to the person.

[0021] This way, it can be ensured that the at least one electronic component mounted to the mounting surface remains fully covered by the second material upon finishing the smart dental device.

[0022] The customized smart dental device being "smart" may comprise the one or more electronic components being configured, for example, to sense a person's dentition movement and / or to provide feedback to the person's dentition movement. For example, the customized smart dental device may comprise overmoulded sensory components and an electronic circuit including an energy storage unit (e.g., a battery), for use in bruxism treatment. Thereby, for example, bruxism, teeth grinding and / or teeth clenching can be monitored and counter measures can be taken, or at least induced (e.g., by alerting the person).

[0023] The digital data set of the invention may be obtained by means of any of a computer-aided design (CAD) system, digital scanning devices, automated topology matching algorithms, etc. For example, the person’s dental surface topology may be obtained by means of an intraoral scan (e.g., a radiological scan, a laser scan, an ultrasound scan, a computed tomography-(CT)-scan, and / or a magnetic resonance tomography-(MRT)-can), a dental imprint (e.g., a plastic or gypsum impression), a three-dimensional (3D) digital patient model, or the likes. Modifications, as required, may then be implemented in silico and a digital dataset of the invention stored in a storage device or output to a manufacturing device.

[0024] The technique of the invention may make use of integrated computer-aided design (CAD) and computer-aided manufacturing (CAM), in short: CAD / CAM. The use of CAD / CAM allows or improves the placing electronic components, such as, for example, sensors, processing units, transmitters, receivers, digital components, circuitry, etc. along the occlusal, lingual or facial sides of the smart dental device. Alternatively, or in addition, CAD / CAM allows or improves combining different manufacturing processes, such as, for example, additive manufacturing (e.g., 3D printing), moulding, milling, etc. The inventive technique thus enables or improves the manufacturing of a customized smart dental device, such as, for example, a Michigan-type splint, a retention device, or the likes, having electronic components included therein, in a timeefficient, cost-efficient and / or automated way.

[0025] The skirt portion digital data set may contain surface boundary information (e.g., in view of the inner surface contour of the skirt portion) for producing the skirt portion.

[0026] Any of the contours of the digital data set may comprise a definition of a shape and a dimension. Dimensions may differ amongst groups of persons, for example, an adult person’s dental surface topology may be larger than a child’s dental surface topology. Also, the person’s dental surface topology may in a top plan view have the general shape of an arch, wherein the width of the arch is often person specific. Further, the (relative) sizes of teeth (and / or voids caused by missing teeth, e.g., after removal thereof) would also contribute to a person-specific shape and / or dimension.

[0027] In the context of the present specification, the smart dental device being customized means that the smart dental device (and hence the dataset used for its manufacturing) is designed with a shape and dimension to be used and / or fit at least a part of the dentition of the person. The smart dental device (and / or its skirt portion) may be configured to keep the person’s palate region unobstructed.

[0028] Moreover, in the context of the present specification, the smart dental device being customized may mean that the skirt portion may snuggly or tightly fits or matches at least a part of the person’s facial dental surface topology, at least a part of the person’s lingual dental surface topology, and / or at least a part of the person’s occlusal dental surface topology. Matching may herein denote a snug fit of a positive shape (also: a positive representation of a structure) to a negative shape (also: a negative representation of a structure), and vice versa.

[0029] The facial surface (and / or facial surface topology) may comprise any surface (and / or contour) oriented towards the outside of the person’s oral cavity (the face). The facial surface may comprise buccal and labial surface portions depending on the position of the respective surface alongthe dental arch.

[0030] The lingual surface (and / or lingual surface topology) may comprise any surface (and / or contour) oriented towards an inner portion of the person’s dental arch (and / orthe palate orthe position of the tongue).

[0031] The occlusal surface (also: masticatory surface and / or chewing surface), and / or the occlusal surface topology, may comprise any surface (and / or contour) oriented generally towards the opposing dentition, against which the teeth abut in the process of biting or grinding.

[0032] Thus, the person’s facial, lingual and / or occlusal dental surface topology can be seen to define a positive contour, whereas the skirt portion would thus represent at least in part a matching or corresponding or fitting negative contour, or vice versa.

[0033] The outer surface contour may cover the inner surface contour and / or may be in a generally parallel arrangement thereto. The definition of the one or more mounting surface portions may define one or more protrusions, one or more indentations, and / or one or more cavities at the second surface portion.

[0034] The one or more mounting surface portions may be provided at the facial surface, the occlusal surface, and / or the lingual surface of the second surface portion. In particular, the mounting surface portions may tend to be located in or at least towards the molar sector of the surface definition of the digital datasets of the invention.

[0035] Alternatively, or in addition, the one or more mounting surface portions may comprise one or more recesses and / or pockets (also: pouches, and / or voids). Pockets, pouches, and / or voids may, after the skirt portion had been overmoulded with the moulding material, help to protect the at least one mounted electronic component more securely from fluid ingress and / or from mechanical stress.

[0036] Mounting surface portions comprising protrusions, indentations and / or cavities, may enable or at least facilitate a more precise positioning and / or fixing in position of the electronic component with high precision of the at least one electronic component may be facilitated. Alternatively, or in addition, the at least one electronic component may be fixed on the one or more mounting surfaces by using an adhesive, such as, for example, using a double-sided adhesive tape applied to the mounting surface portion before the placement of an electronic component.

[0037] Alternatively, or in addition, the one or more mounting surface portions may comprise one or more spacers. E.g., the one or more spacers may ensure that after mounting the at least one electronic component, a hollow space at least partially surrounding the at least one electronic component remains, which may be filled with a mould cavity filling material or even be designed to remain unfilled (e.g. to provide a gas-filled void in the material).

[0038] The at least one electronic component is preferably mounted at the facial side of the outer surface contour and / or in the molar sector of the customized smart dental device due to the preferable availability of a certain anatomical void in that area, which helps to avoid space and / or thickness constraints with the smart dental device.

[0039] At least a part of the one or more mounting surface portion may include a meandering section for mounting at least one electric or optical lead. The meandering form may be customized to the person’s dental surface topology and may be designed to achieve, for example, a defined total length, capacity or inductivity.

[0040] The at least one electronic component may comprise at least one electric or optical connection (also: lead). By using a meandering form of the lead path, the at least one electrical or optical connection may achieve a standardised length despite different patient anatomies. The at least one connection may thus be customised to the person’s dimension and shape of the dental arc and its dental surface topology by customizing the meandering form.

[0041] For example, the smart dental device may include several electronic components, which may be pre-assembled and / or standardized electronic unit, such as, for example, an energy storage unit, a microprocessor, a sensor system, an actuator, a transmission component, and the at least one electrical connection connecting these components to one another and / or the energy storage unit (also: power source).

[0042] The energy storage unit may be mountable at the facial surface of the skirt portion, for example, due to more strict thickness constraints on the smart dental device along the lingual and / or occlusal sides than on the facial side. Alternatively, or in addition, at least one sensor may be mountable at the occlusal surface of the outer surface contour of the skirt portion, for example, for sensing a force and / or pressure, such as when clenching the teeth.

[0043] The skirt portion may be arranged or positioned such that the smart dental device does not contact the person's gums when wearing it. Alternatively, or in addition, the skirt portion may be arranged or positioned such that the smart dental device covers the person’s teeth at most partially when wearing it. For example, to ensure a good fit, in a molar sector, in particular, both molar sectors of the mandibula and / or the maxillary, the smart dental device may cover the teeth nearly entirely to ensure a secure fit. Alternatively, for a comfortable fit, the smart dental device may cover the person’s frontal teeth only partially.

[0044] The arrangement relative to the dental neck area and / or distanced from the gum area of the person’s dental surface topology may define a teeth coverage of the smart dental device in terms of a customized dental model.

[0045] Sealingly engaging of the sealing structures of the skirt portion and of the mould portion may comprise providing a sealed configuration for filling the mould cavity. For example, the sealed configuration may be fluid-tight, at least for a viscous (second) material to be filled into the mould cavity. A sealing engagement may be achieved by providing a sealing geometry by which the skirt portion and the mould portion engage in a fluid-tight way, such as a labyrinth seal or a pressing seal, for example, with one side being configured with a pointed edge, preferably made from a hard material, and the other side configured with a non-pointed sealing face, preferably made from a softer material, into which the pointed edge presses, when the sealing faces are in an engaging arrangement. Alternatively, or in addition, the sealing structures may comprise one or more protrusions, such as, for example, cusps, peaks and / or apexes, and recesses for receiving such protrusions, to form labyrinths. Optionally, the at least one skirt-side protrusion and / or recess may be arranged at a facial and / or lingual surface portion of the outer surface contour.

[0046] The sealing structure of the skirt portion and the sealing structure of the mould portion may be configured to engage sealingly along at least one contact line, and preferable a closed contact line. The sealing structure for sealingly engaging to the sealing structure of the mould portion may at least partially define the mould cavity.

[0047] The mould cavity may be a hollow space (also: hollow form, mould space) arranged for filling with a (second and / or mould filling) material. In this context, it is noteworthy that the filling of the mould cavity may not only happen after the skirt portion and the mould portion have been brought into an engaging arrangement but the filling material may, for example, in a viscose form be filled into a space provided by the mould portion, following which the skirt portion may be brought into the engaging arrangement with the mould portion and thus achieving the overmoulding byway of a process similar to die casting. Generally, filling the mould cavity and ensuring that the filling material (second material) covers the electronic components arranged on the mounting surfaces may also be denoted as overmoulding.

[0048] The person may be a patient, for example, at a dental office, a sleep specialist office, and / or a neurologist office. The smart dental device may comprise a therapeutic device, such as a dental treatment device. The dental treatment device may comprise a splint (also: bite-splint and / or intraoral split, such as a Michigan splint), a guard (in particular, an aligner-like guard, a sport guard, and / or a night guard), a retainer, a dental brace, and / or an anti-snoring device.

[0049] Alternatively, or in addition, the smart dental device may comprise a medical status monitoring device (e.g., comprising one or more electroencephalography, EEG, and / or electrocardiography, ECG, sensors, and / or one or more sensors for monitoring for an onset of an epileptic seizure). Further, alternatively, or in addition, the smart dental device may comprise a voice recorder, a dictation device, and / or a telecommunications device (e.g., functioning as microphone, antenna and / or loudspeaker).

[0050] The smart dental device (and / or the skirt portion and / or the mould cavity) may in one embodiment be provided along a (e.g., inner) surface contour covering essentially the full person's dental surface topology (e.g., comprising the person's left and right molar sectors, the person's left and right eyetooth sectors, and the person's incisor sector). This embodiment can provide a particularly stable hold of the smart dental device at the person's dental surface topology. Alternatively, or in addition, only one microprocessor and energy storage unit may be required with sensors and / or feedback components installable on both (in particular, left and right) molar sectors.

[0051] The skirt portion and / or the at least one skirt-side sealing structure may be defined to be located at least along a molar sector of the outer surface contour. Optionally, the skirt portion and / or the at least one skirt-side sealing structure may be defined to be located along both molar sectors of the outer surface contour. Similarly, the mould cavity may be provided at least along a molar sector of the outer surface contour. Optionally, the mould cavity may be provided along both molar sectors of the outer surface contour.

[0052] The smart dental device (and / or the skirt portion and / or the mould cavity) may essentially only cover a molar sector, or both molar sectors separately. This embodiment can be particularly material-efficient and / or avoid constructional challenges that can arise due to a need for a very thin incisor sector portion. In this embodiment, a separate microprocessor and energy storage unit may be required per molar sector. Alternatively, or in addition, the skirt portion data set and the mould portion data set may comprise each a separate data set per molar sector. Manufacturing the smart dental device according to this embodiment may comprise separately manufacturing one molar sector part of the smart dental device.

[0053] By the at least one protrusion and / or recess a position and / or an orientation of the skirt portion relative to the mould portion (or vice versa) may be detected and / or controlled, such as, for example, by an automatic manufacturing device. Thereby, assembling and engaging in a sealing engagement the skirt portion and the mould portion, and, optionally, filling of the mould cavity, can be performed with very high precision for customizing the smart dental device to the person’s opposite occlusal surface, and optionally using an automatic process.

[0054] The skirt portion digital data set may further define at least one skirt-side retention structure configured to interlock with a mould-side engagement structure of a mould portion. The at least one skirt-side retention structure may enable a sealing engagement of the skirt-side sealing structure and the mould-side sealing structure of the mould portion. The skirt-side retention structure and the mould-side engagement structure may be arranged in an interlocking engagement. In particular, the skirt portion and the mould portion may be held in place (e.g., for the sealing engagement) relative to each other by means of at least one protrusion and / or recess, such as, for example, a pin / socket or shoulder / recess arrangement having a locking effect. The at least one protrusion and / or recess may be arranged at or in proximity to the sealing structures.

[0055] The skirt portion digital data set may further define at least one registration mark and / or at least one registration pin. Optionally, the at least one registration mark and / or registration pin may be arranged on a facial surface portion. In another embodiment, at least one registration mark and / or registration pin may be arranged on each of the lingual surface portion and the facial surface portion.

[0056] The at least one registration mark (also: registration element) may comprise a pin and / or a groove. The at least one registration mark can be used for an automatic processing by allowing the registering of the position and orientation of the manufactured workpiece in a downstream processing step, such as a subtractive processing machine, a robotic handling or manufacturing device, or the like.

[0057] Thereby, a workpiece obtained from the filling of the mould cavity, i.e. one where the electronic components have been overmoulded, for example, using the second material, can be processed with very high precision for customizing the smart dental device to the person’s opposite occlusal surface. Advantageously, using the registration marks, the correct positioning and orientation of the workpiece inside the subtractive processing device can be ensured. This way, it can also be ensured that the at least one electronic component remains fully covered after the processing and that the customised smart dental device is manufactured at a very high precision. By the finishing of the workpiece in such downstream processing, the smart dental device may be obtained. Finishing may, in particular, comprise fine-tuning an occlusal surface portion of the smart dental device after the mould is filled to form the occlusal surface portion.

[0058] The skirt portion digital data set may further comprise at least one support structure facilitating the additive manufacturing of the skirt portion. The at least one support structure may facilitate the additive manufacturing process of the skirt portion, in particular, in the presence of undercuts (e.g., due to a reduced tooth diameter at a dental neck comprised in the person’s dental surface topology). Optionally, the at least one support structure may be arranged along an occlusal, facial and / or lingual surface portion of the outer surface contour of the skirt portion.

[0059] The at least one support structure may comprise auxiliary support points, pins, abutments and / or pillars. Alternatively, or in addition, the at least one support structure may be arranged for easily removing, such as, for example, by grinding or milling before assembly with the mould portion for forming the mould cavity, in particular, for filling the mould cavity with a second material different from the first material used for (additive) manufacturing of the skirt portion.

[0060] The definition of the one or more mounting surface portions may define one or more protrusions, one or more indentations, and / or one or more cavities at the second surface portion.

[0061] The one or more mounting surface portions may be provided at the facial surface, the occlusal surface, and / or the lingual surface of the second surface portion. In particular, the mounting surface portions may tend to be located in or at least towards the molar sector of the surface definition of the digital dataset of the invention.

[0062] Alternatively, or in addition, the one or more mounting surface portions may comprise one or more recesses and / or pockets (also: pouches, and / or voids). Pockets, pouches, and / or voids may, after the skirt portion had been overmoulded with the moulding material, help to protect the at least one mounted electronic component more securely from fluid ingress and / or from mechanical stress.

[0063] Mounting surface portions comprising protrusions, indentations and / or cavities, may enable or at least facilitate a more precise positioning and / or fixing in position of the electronic component with high precision of the at least one electronic component may be facilitated. Alternatively, or in addition, the at least one electronic component may be fixed on the one or more mounting surfaces by using an adhesive, such as, for example, using a double-sided adhesive tape applied to the mounting surface portion before the placement of an electronic component.

[0064] Alternatively, or in addition, the one or more mounting surface portions may comprise one or more spacers. E.g., the one or more spacers may ensure that after mounting the at least one electronic component, a hollow space at least partially surrounding the at least one electronic component remains, which may be filled with a mould cavity filling material or even be designed to remain unfilled (e.g. to provide a gas-filled void in the material).

[0065] The at least one electronic component is preferably mounted at the facial side of the outer surface contour and / or in the molar sector of the customized smart dental device due to the preferable availability of a certain anatomical void in that area, which helps to avoid space and / or thickness constraints with the smart dental device.

[0066] At least a part of the one or more mounting surface portion may include a meandering section for mounting at least one electric or optical lead. The meandering form may be customized to the person’s dental surface topology and may be designed to achieve, for example, a defined total length, capacity or inductivity.

[0067] The at least one electronic component may comprise at least one electric or optical connection (also: lead). By using a meandering form of the lead path, the at least one electrical or optical connection may achieve a standardised length despite different patient anatomies. The at least one connection may thus be customised to the person’s dimension and shape of the dental arc and its dental surface topology by customizing the meandering form.

[0068] For example, the smart dental device may include several electronic components, which may be pre-assembled and / or standardized electronic unit, such as, for example, an energy storage unit, a microprocessor, a sensor system, an actuator, a transmission component, and the at least one electrical connection connecting these components to one another and / or the energy storage unit (also: power source).

[0069] The outer surface contour of the skirt portion may comprise a predefined surface roughness and / or predefined surface features, such as protrusions and / or recesses, for physically engaging with a mould cavity filling material (e.g., the second material). Such predefined surface roughness may lead to the increase of the contact surface between the material forming the outer surface contour and the filling material. This way, the physical engagement of the skirt portion, i.e. the first material with the mould cavity filling material, such as, the second material may be improved.

[0070] Alternatively, or in addition, the predefined surface features, in particular the protrusions, recesses and / or cavities, enhance the physical engagement of the skirt portion (in particular, the first material) with the mould cavity filling material (in particular, the second material).

[0071] The dental surface topology may comprise a maxillary dental surface topology. Alternatively, or in addition, the dental surface topology may comprise a mandibular dental surface topology. For example, in first embodiment, the smart dental device may be customized to fit the person’s maxillary dental surface topology. In a second embodiment, the smart dental device may be customized to fit the person’s mandibular dental surface topology. In a third embodiment, the smart dental device may be customized to fit both the person’s maxillary dental surface topology and the person’s mandibular dental surface topology.

[0072] In one embodiment, the smart dental device may be arranged for use with only the upper or lower jaw, i.e. the maxilla (also: upper jaw) or mandible (also: lower jaw). In this case, an outer surface of the smart dental device, in particular, the side opposite the innersurface contour, may be configured for matching the occlusal surface of the opposite jaw.

[0073] In another embodiment, the smart dental device may be arranged for use with both jaws (i.e., upper and lower jaw). In this case, the outer surface of one jaw’s portion of the smart dental device may match the outer surface of the otherjaw’s portion of the smart dental device.

[0074] In a further embodiment, each jaw side portion of the smart dental device may comprise at least one electronic component, such as, for example, at least one sensor in one jaw side portion and at least one feedback component in another jaw side portion. Optionally, the electronic components of the multiple jaw side portions can be configured to be in a communicative connection so as to operate in unison.

[0075] In a second aspect of the invention (a first device aspect), a skirt portion of a customized smart dental device for a person is provided. The skirt portion tightly fits at least a facial, lingual and / or occlusal dental surface topology of the person. The skirt portion comprises an inner surface contour customized to match (or matching) the facial, lingual and / or occlusal dental surface topology. The inner surface contour comprises an occlusal surface, a facial surface and a lingual surface. The inner surface contour forms an inner surface of the skirt portion. The skirt portion further comprises an outer surface contour.

[0076] The outer contour comprises one or more mounting surface portions for mounting at least one electronic component. The outer surface contour of the skirt portion comprises at least one skirtside sealing structure configured to engage sealingly with a mould-side sealing structure of a mould portion. The skirt-side sealing structure comprises a of a mould cavity formed by at least a part of the outer surface contour of the skirt portion as a portion of the inner mould cavity contour.

[0077] The skirt portion may be defined by the skirt portion digital data set according to the first aspect of the invention.

[0078] In a third aspect of the invention (a first method aspect), which may be partly computer implemented, a method for manufacturing a skirt portion customized to match a facial, lingual and / or occlusal dental surface topology of a person according to the first device aspect (or the second aspect of the invention) is provided. The method comprises a step of controlling a manufacturing device to manufacture, using a first material, the skirt portion.

[0079] The manufacturing may be done using an additive manufacturing process, such as, for example, 3D printing.

[0080] The method may further comprise a step of loading the skirt portion digital data set of the first aspect of the invention into a memory of a manufacturing device implementing the manufacturing process.

[0081] The customized smart dental device may be manufactured in multiple steps. For example, the skirt portion (e.g., made of a first material) and a mould portion (e.g., made of an auxiliary mould material) may be manufactured separately. The at least one electronic component may be mounted on the skirt portion. The skirt portion and mould portion may then be positioned in a sealing engagement such that they form a mould cavity which is filled (e.g., with a second material, also: mould cavity filling material, briefly: filling material). Finally, the mould portion may be removed, for example, in a subtractive manufacturing process, dissolved, or by retaining the mould portion if it is manufactured for a multi-use configuration (e.g. made from metal). In some embodiments, a fine adjustment (and / or refinement) of the occlusal surface of the smart dental device may at the end of the manufacturing process be performed (e.g., manually by a dentist).

[0082] The manufacturing of the skirt portion may comprise additive forming. The skirt portion may be manufactured using a first material, for example, by forming of a film. The film may be made of a thermoplastic material or another polymeric material that can be set or cured to retain a shape given in a soft / formable state. The film may be overlayed over a positive of at least a portion of the person’s dental surface topology, such as, the facial, lingual and / or occlusal dental surface topology, in the labial and / or the molar sector.

[0083] The manufacturing of the skirt portion may further comprise the steps of additively manufacturing, according to the loaded skirt portion digital data set and using a first material at least one skirt-side retention structure, at least one registration mark, and / or a predefined surface roughness and / or predefined surface features.

[0084] The first material may comprise a hard material or a soft material. Alternatively or in addition, the first material may be hard at room temperature, medium hard at 37°C and medium soft at warm water temperature of 45°C to 55°C. The first material may, for example, be a thermoflex material, a thermoplastic material, a resin, and / or a photopolymer.

[0085] The hard material may, e.g., have (and / or may be defined by having) a bending strength between 10 MPa and 100 MPa. E.g., a photopolymer (in particular, marketed under the name “KeySplint Hard”) may have the physical properties of an elastic modulus (also: E-modulus) between 1510 MPa and 1520 MPa (e.g., accordingto ISO 20795-2), a bending strength between 60 MPa and 65 MPa (e.g., according to ISO20795-2), and / or a water absorption of 18 micro-g / mm3 (e.g., accordingto ISO20795-2).

[0086] The first material and / or a mould cavity filling material (and / or second material) may be (and / or may comprise) a biocompatible material, such as a biocompatible resin.

[0087] Biocompatible resins that may be (or may be considered for) the hard material (and / or hard material part(s)) comprise an acrylic material, acrylate, methacrylate, Cyclic Olefin Polymer (COP), Cyclic Olefin Copolymer (COC), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), polycarbonate (PC), polypropylene (PP), polyethylene terephthalate (PET), polyimide, polyetherimide (PEI), nylon, and / or Ultem. The hardness may be typically in the range of 2000 MPa to 3500 MPa (e.g., forthe E-modulus) for a hard bite dental device (e.g., splint). Milled acrylic material may be typically harder than a printed and / or thermoformed dental device (such as a splint) and may, optionally, be considered as a benchmark to reach. A milled acrylic material used may, e.g., have an E-modulus of approximately 3100 MPa.

[0088] The soft material may, e.g., have (and / or may be defined by having) a bending strength between 2 MPa and 4.5 MPa. E.g., a biocompatible 3D printing resin (in particular marketed underthe name “KeySplint Soft”) may have the physical properties of a Shore hardness of 82 (e.g., according to Scale D), an elastic modulus of 1356 MPa (e.g., according to ASTM D790), a bending strength between 2.6 MPa and 4.4 MPa (e.g., according to ISO20795-2), and / or a water absorption of less than 18 micro-g / mm3 (e.g., according to ISO20795-2).

[0089] The soft material may be (or may comprise) a thermoplastic polyurethane (TPU), COP, silicone, acrylate and / or methacrylate. A hardness range for the soft material may often be measured differently from a hardness range for hard materials (e.g., using the E-modulus) and may, e.g., be indicated with a shore hardness for the soft material. At room temperature (e.g., around 20°C to 22°C), the soft material (e.g., KeySplint soft) may be relatively hard but may become softer in warm water and / or in the person’s oral cavity.

[0090] The method may further comprise a step of providing, that is, defining in the digital data set and consecutively manufacturing a support structure for manufacturing the skirt portion, preferably by additive manufacturing. Optionally, the support structure may be meltable or dissolvable by a solvent to allow removal of the support structure after manufacturing the skirt portion.

[0091] Optionally, the support structure may be removed by milling, grinding, cutting, or any other subtractive process.

[0092] The support structure may alternatively, or in addition, be provided before the skirt portion is manufactured. Thereby, manufacturing the skirt portion with a high precision of its shape may be further facilitated. The (meltable or dissolvable) support structure may be provided for matching / supportingthe inner surface contour. It may be removed, e.g., by melting or dissolving, before any further step of the method is performed, such as, before mounting the at least one electronic component. If the support structure is provided for matching the inner surface contour, if may be removed, such as, by melting or dissolving, after the smart dental device has been manufactured. The material of the support structure may thus differ from the first material and from the second material used for manufacturing the smart dental device to allow melting or dissolving thereof. The material of the support structure may, in particular, be softer, having a lower temperature melding point than the first material and the second material and / or may be dissolvable by a solvent (which does not affect / dissolve the first material and the second material).

[0093] The support structure manufactured according to the skirt digital data set may extend outwards from the outer surface contour of the skirt portion, in particular, towards the outer mould contour. Removing the support structure of the skirt portion may be comprised in the process of milling / grinding and / or polishing of the outer surface contour. In some embodiments, it may be sufficient to remove the additively manufactured support structure only partially, e.g., leaving remnants at the outer mould contour.

[0094] The skirt portion of the first device aspect (second aspect of the invention) may be manufactured using the method according to the first method aspect (third aspect of the invention).

[0095] In a fourth aspect of the invention (a second digital data set aspect), a mould portion digital data set for use in manufacturing of an occlusal portion of a customized smart dental device tightly fitting at least a facial, lingual and / or occlusal dental surface topology of a person is provided. The occlusal portion matches at least an opposing occlusal dental surface topology of the person.

[0096] The mould portion digital data set defines an inner surface contour of the mould portion. The inner surface contour of the mould portion is customized (or configured) to match at least the occlusal shape of the opposing dental arc of the person. The mould portion digital data set further defines an outer surface contour of the mould portion. The outer surface contour of the mould portion defines at least one mould-side sealing structure configured to engage sealingly with a skirt-side sealing structure of a surface contour of a skirt portion defined by a skirt portion digital data set according to the first digital data set aspect. The mould-side sealing structure defines a boundary line of the mould cavity defined by at least a part of the inner surface contour of the mould portion as a portion of the inner mould cavity contour.

[0097] The mould portion digital data set may be embodied on a transient or non-transient storage medium or on a carrier wave in a packeted form, such as, for example, in TCP / IP packets or as a stream, such as, for example, a UDP stream. According to the present disclosure, configured to engage sealingly refers to a state of engagement of the two units, i.e. the skirt portion and the mould portion, in which they are mounted to one another to provide a mould cavity which is substantially fluid tight, however, may also include certain openings to enable an egress of material.

[0098] The mould portion digital data set may contain surface boundary information (e.g., in view of the inner surface contour of the mould portion) for producing the mould portion.

[0099] At least parts of the inner surface contour of the mould portion and of the outer surface of the skirt portion may define (or provide) the mould cavity configured for holding or filling with the mould cavity filling material, such as, the second material. The first material of the skirt portion and the second material, i.e. the mould cavity filling material, may be configured for fitting and / or bonding to form the outer shape of the smart dental device. The inner surface contour of the mould portion may be defined to match an occlusal shape of the opposing dental arc of the person, which may include the occlusal surface of the opposing dental topology.

[0100] The inner surface may, however, also be defined as a standardized surface, such as, a surface not being exactly fitted to the opposing dental topology, which, however, allows for further refinement and adaptation to the opposing dental topology by a downstream processing, such as subtractive processing (e.g., milling or grinding). For example, the standardized inner surface of the mould portion may comprise a flat surface as the occlusal surface. Alternatively, or in addition, the standardized inner surface of the mould portion may comprise a smooth lingual surface and / or a smooth facial surface, in particular, without indentations between neighbouring teeth.

[0101] The mould portion digital data set may further define at least one fluid-connecting runner system extending from the outer surface contour of the mould portion to the inner surface contour of the mould portion. Such a runner channel (also: filler bore and / or outlet) may comprise a lead path for filling the mould cavity with mould cavity filling material, such as, the second material.

[0102] Alternatively, or in addition, the at least one runner channel may provide an outlet for air, venting and / or for pressure compensation (e.g., while filling the mould cavity with the mould cavity filling material, in particular the second material).

[0103] The portion of the runner system (and / or parts of the surrounding outer surface contour) located towards outside of the mould portion, i.e. the mould material inlet, may be designed to have a suitable connection structure so as to allow a secure connection of a mould filling material source, such as, an injection nozzle or the likes. The connection structure may be in the form of a thread, bayonet catch, or any other suitably designed connector, to ensure a secure connection of the filling material source during the injection (or infiltration) process.

[0104] The outer surface contour of the mould portion may define a standardised outer shape. In particular, the standardised outer shape may comprise a circular shape (e.g., preferably, having a predetermined radius), a polygonal shape and / or an arched shape (e.g., preferably having a predetermined size and a predetermined shape). The standardized outer shape may be selected depending on the choice of manufacturing device (and / or a container, e.g., having a circular shape), which may be used for the downstream processing or handling of the mould portion (while sealingly engaged with the skirt portion or not).

[0105] Alternatively, or in addition, e.g., for saving on the part of the auxiliary mould material when manufacturing the mould portion, the mould portion may have an inner surface contour of the mould portion digital data set having at least in same portions of the mould portion be generally parallel (i.e., extending roughly along the same direction) to the outer surface contour of the mould portion.

[0106] The at least one mould-side sealing structure may define at least one recess and / or protrusion configured to sealingly engage with at least one corresponding protrusion and / or recess of the skirt-side sealing structure. Optionally, the at least one mould-side recess and / or protrusion may be arranged adjacent to a facial and / or lingual surface portion of the inner surface contour. The matching recesses and protrusions of the mould portion and the skirt portion, enable a sealing engagement of the mould portion and the skirt portion for filling the mould cavity after having been assembled.

[0107] In a fifth aspect of the invention (a second device aspect), a mould portion for manufacturing a customized smart dental device for a person is provided. The mould portion comprises an inner surface contour. The inner surface contour of the mould portion is customized to match at least the occlusal shape of the opposing dental arc of the person. The mould portion further comprises an outer surface contour. The outer surface contour of the mould portion comprises at least one mould-side sealing structure configured to engage sealingly with a skirt-side sealing structure of a surface contour of a skirt portion according to the first device aspect. The mould-side sealing structure defines a boundary line of the mould cavity formed by at least a part of the inner surface contour of the mould portion as a portion of the inner mould cavity contour. The mould portion may be manufactured using the method according to this second method aspect. The mould portion may be defined by the mould portion digital data set according to the second digital data set aspect (the fourth aspect of the invention).

[0108] In an embodiment, the method for manufacturing a mould portion for manufacturing a customized smart dental device for a person according to the second device aspect is at least partially implemented by a suitably programmed computer. In this embodiment, the method comprises a step of controlling the manufacturing device to manufacture the mould portion, for example, by additive manufacturing, such as, 3D printing. The method may further comprise a step of loading a mould portion digital data set into a memory of an additive manufacturing device.

[0109] The manufacturing the mould portion may further comprise a step of manufacturing, according to the loaded mould portion digital data set, at least one fluid-connecting runner system. Thus, the mould portion may comprise at least one channel configured as a runner system for filling in the mould cavity filling material when producing the smart dental device (and / or at least its occlusal surface). Alternatively, or in addition, the mould portion may comprise additional channels for venting or pressure relief, to enable a faultless filling of the mould cavity after the mould portion and the skirt portion have been assembled into the sealing engagement.

[0110] The mould material (also: auxiliary mould material) may be independently chosen from the first material for manufacturing the skirt portion and the mould cavity filling material, i.e. the second material, for manufacturing at least the occlusal surface of the customized smart dental device.

[0111] The mould forming material (and / or the second material) may comprise a hard material. The hard material may, for example, be a hard-acrylic material.

[0112] In a sixth aspect of the invention (a third method aspect), a method for manufacturing a customized smart dental device for a person by using a skirt portion according to the first device aspect and a mould portion according to the second device aspect is provided. This method may be partly implemented by a suitably programmed computer.

[0113] The method comprises a step of mounting at least one electronic component on the one or more mounting surface portions of the outer surface contour of the skirt portion. The method further comprises a step of mounting the mould portion to the skirt portion (also: assembling) comprising the mounted at least one electronic component for defining a mould cavity. The assembling comprises engaging sealingly the at least one sealing skirt-side sealing structure of the skirt portion with the at least one mould-side sealing structure of the mould portion.

[0114] The method further comprises a step of filling the mould cavity with a filling material (also: mould cavity filling material). Filling with the filling material may be after the assembly of the mould portion with the skirt portion, or alternatively, the filling material may be applied prior to the assembly of the mould portion and the skirt portion and the material then egressing, for example, through pressure relief channels, vents, or gaps provided in the seal for this purpose, when assembling the mould portion and the skirt portion.

[0115] The method may further comprise a step of curing or setting the filling material or allowing the filling material to set, thereby creating an occlusal portion of the smart dental device which is fluid-tightly embedding the at least one electronic component. The method still further comprises a step of removing the mould portion.

[0116] The method may comprise applying an adhesive agent (also: bonding agent, binder agent, and / or rheological additive) to the part of the outer surface contour of the skirt portion defining a portion of the mould cavity contour.

[0117] Alternatively, or in addition, the method may comprise a step of applying a mould release agent to the part of the inner surface contour of the mould portion defining a portion of the mould cavity contour.

[0118] In an embodiment, the at least a part of the mounted electronic components may be fixed by filling mould filling material into a cavity, a pouch and / or pocket which are configured as a mounting surface portion before mounting the mould portion to the skirt portion. This fixes the electronic component in place and ensures a correct positioning is retained during the filling process.

[0119] The method of the sixth aspect provides a customized smart dental device comprising fluid-proof (e.g., waterproof, and / or protected from saliva) sealed electronic components, such as, for example, an energy storage unit, microprocessor, sensors, power connections, actuators, and / or the likes, and which is optimally fitted to the person’s tooth status.

[0120] The method for manufacturing the customized smart dental device may make use of CAD / CAM, such as, for example, in the processes of manufacturing the skirt portion and / or the mould portion. Thus, the method of the sixth aspect may make use of CAD for the skirt portion digital data set (e.g., for fitting to the person’s dental topology) and / or for the mould portion digital data set, and / or for the mounting of the at least one electronic component, and / or for milling the mould cavity material (e.g., the second material) after filling the mould cavity. Alternatively, or in addition, the mould portion digital data set may make use of a digital bitefinderfor matchingthe person’s opposite occlusal surface.

[0121] The first material used for the manufacturing of the skirt portion may be softer and / or more bendable than the mould cavity filling material, i.e. the second material. The first material may, in particular, be selected for an optimal fit and comfortable fit to the person’s individual dental topology.

[0122] The mould cavity filling material, i.e. the second material, may be selected for sufficient strength to protect the at least one electronic component and / or for ensuring a longevity of the smart dental device (e.g., at least two years, preferably at least five years when worn daily by the person). In particular, the occlusal surface of the smart dental device is advantageously made from a strong material given the potentially high pressure and shearing / grinding forces exerted by the person’s jaws during bruxism. The mould cavity filling material, such as, the second material, may comprise a hard material. The hard material may, for example, be a hard-acrylic material.

[0123] An undercut section, for example, due to a reduced tooth diameter at a dental neck area comprised in the person’s dental surface topology, may only comprise the first material; there are only comparatively little shearing / grinding forces applicable at this part of the smart dental device.

[0124] The method may be performed in a laboratory, such as s dental laboratory and / or manufacturing workshop. Alternatively, or in addition, the outer geometry of the workpiece (i.e., the smart dental device) may be manually fine-tuned and / or polished by a specialist, such as, a dentist and / or a dental technician.

[0125] Alternatively, or in addition, the occlusal surface of the customized smart dental device may be manually fine-tuned and / or polished by a specialist, such as, a dentist or a dental technician, for example, by using a dental burr. The skirt portion together with the mould cavity filling material (i.e., the second material) may be denoted as an unfinished workpiece, for example, where ridges exist at the transition between the first material and the mould cavity filling material and / or other positions of the smart dental device exist. The customized smart dental device may also be denoted as finished workpiece.

[0126] In an embodiment, in particular, after the filling material has been filled into the mould cavity and set or cured, or been allowed to set, the method may further comprise a step of removing at least one sealing structure of the skirt portion. Alternatively, or in addition, the method may also comprise a step of removing at least one retention structure and / or at least one registration mark of the skirt portion. Alternatively, or in addition, the method may further comprise a step of removing at least a part of the mould portion and / or may further comprise a step of fine-tuning and / or removing at least a part of the occlusal portion ofthe smart dental device. Removal may be effected by a suitable subtractive process, such as, milling, grinding, cutting, blasting, breaking, etc..

[0127] For example, the at least one protrusion ofthe sealing structure of the skirt portion may only be required for the sealing engagement ofthe mould portion when filling the mould cavity. Afterwards, the at least one protrusion may be removed to ensure a comfortable fit of the smart dental device in the person’s oral cavity.

[0128] The at least one electronic component may comprise an (e.g., electrical) energy storage unit, a microprocessor, at least one sensor and (e.g., electrical) connections for providing (e.g., electrical) energy from the (e.g., electrical) energy storage unit to at least the microprocessor and the at least one sensor. Optionally, the energy storage unit may be wirelessly rechargeable.

[0129] Alternatively, or in addition, the at least one electronic component my operate optically and / or light-based.

[0130] The at least one electronic component (e.g., the energy storage unit, the microprocessor, the at least one sensor, and / or connections, in particular, if co-located at one surface mounting portion such as at a facial side of the skirt portion) may be embodied by a printed circuit board (PCB), which may be flexible to be adaptable to the curvature of correspondingly shaped mounting portions of the smart dental device. The PCB may for example comprise some sensors. The PCB may be connected to other sensors with wires (e.g., for energy connection and / or data connection) and / or flexible circuit boards, as for example in the case for occlusal force measurement.

[0131] The size of the PCB may comprise a length between 5 mm and 35 mm and / or a width between 3 mm and 15 mm (and / or L x W: e.g., 5 x 3 mm2to 35 x 15 mm2). Preferably, the length of the PCB is below 20 mm and the width of the PCB is below 10 mm (and / or below 20 x 10 mm2). The PCB may have a thickness of any value between 1 mm to 5 mm, inclusive, as required by the use case.

[0132] The at least one electronic component may alternatively or in addition comprise a light source (e.g., a LED, an OLED, a laser diode, etc.). The light source may, e.g., be activable for correctly positioning the smart dental device inside the person’s mouth, and / or for finding the smart dental device, for example, in the dark. Other uses for activating the light source may be expedient, such as, for example, for performing chemical (e.g., spectral) analyses of the person’s salvia, breath or skin in the oral cavity.

[0133] The at least one sensor may comprise at least one sensor pad and / or at least one sensor film. The sensor may be reading pressure, force, such as, shearing force, light flux, spectral components of light, temperature, acceleration, spatial orientation, sound, electromagnetic waves, etc. More specifically, the at least one sensor may, e.g., comprise a temperature sensor, a biosensor, a ultrasound sensor, an oxygen saturation sensor, a pH sensor, an ion sensor, a humidity sensor, an electrocardiography (ECG) sensor, a respiration sensor, a heart rate sensor, a blood pressure sensor, an electroencephalographic (EEG) sensor, and / or an infrared (IR) sensor.

[0134] A thickness of the at least one sensor, in particular, for use along the occlusal surface of the smart dental device, may be in the range between 0.05 mm and 0.5 mm, preferably between 0.1 mm and 0.4 mm, more preferably between 0.2 mm and 0.3 mm.

[0135] The at least one sensor may comprise a sensor suitable for detecting bruxism. E.g., the at least one sensor may comprise a pressure sensor, a force sensor, a motion sensor, a sound sensor, an optical sensor, and / or a camera.

[0136] The at least one sensor may be configured to be suitable for detecting the person’s health condition, such as, for example, the onset of an epileptic or cramping seizure, for example, in time for taking preventive medicine, apply (or control application of) electric stimulation, or the like. The at least one sensor may, e.g., comprise a temperature sensor, a biosensor, an ultrasound sensor, an oxygen saturation sensor, a pH sensor, an ion sensor, a humidity sensor, an electrocardiography (ECG) sensor, a respiration sensor, a heart rate sensor, a blood pressure sensor, an electroencephalographic (EEG) sensor, and / or an infrared (IR) sensor.

[0137] The at least one electronic component may be at least partially flexible. E.g., electrical connections may be at least partially flexible, and / or a sensor pad and / or sensor film may be at least partially flexible.

[0138] The at least one electronic component (e.g., the microprocessor, energy storage unit and / or at least one sensor) may in some embodiments have a length between 5 mm and 25 mm, and / or a width between 3 mm and 15 mm. Alternatively or in addition, the at least one electronic component (e.g., the microprocessor, energy storage unit and / or at least one sensor) may have a thickness between 1 mm and 5 mm.

[0139] The at least one electronic component may comprise a communication unit. Optionally, the communication unit may comprise an antenna for wirelessly transmitting data. The data may, for example, have been acquired by means of the at least one sensor over a period of time and stored in a memory included in the smart dental device, for later read-out using the communication unit.

[0140] The communication unit may be configured for wirelessly transmitting (e.g., using Bluetooth, WiFi, near field communication, and / or a telecommunications network such as 4G / 5G / 6G) data, in particular, the sensor data.

[0141] The communication unit may be configured for communicating with an external device, for example, of a dentist, sleep specialist, and / or a neurologist. Thereby, the person and / or the medical practitioner can monitor the person’s bruxism, sleeping pattern and / or health state.

[0142] The data may comprise data received by the smart dental device from the person’s device and / or from the medical practitioner’s device. The data received at the smart dental device may, e.g., comprise instructions for activating at least one feedback component, such as, an actuator, e.g., for generating vibrations to reduce bruxism.

[0143] The at least one sensor may be configured to be suitable for detecting the person’s health condition, such as, for example, the onset of an epileptic or cramping seizure, for example, in time for taking preventive medicine, apply (or control application of) electric stimulation, or the like.

[0144] Electronic components, such as the PCB and / or circuit board including one or more microprocessors, energy storage unit (also: batteries) and / or large area components like an antenna, such as, for near field communication, NFC, may preferably be placed at the facial buccal portion of the smart dental device.

[0145] One or more occlusal force sensors may be placed in the occlusal posterior (and / or buccal) area, and even more preferably in any one (or all) of the occlusal contact areas.

[0146] One or more additional sensors (e.g., different from occlusal force sensors), may be used, for example, in the region of an approximal position, such as, for example, sensors to determine the presence of caries lesions or biofilms, for example, in the interdental space. Alternatively, or in addition, further additional sensors may be used, such as, for example, blood oxygenation sensors, perfusion and / or blood pressure sensors and placed so as to extend towards and / or be in contact with the gingiva, lingual and / or on the palate. Sensors being placed in contact with soft tissue, such as, the gingiva or palate, may enable determination of information on the physical status of the person wearing the device.

[0147] Similarly, any sensors may alternatively or in addition be placed on a PCB and / or circuit board, preferably at the buccal side and / or placed as small bracelets around a tooth.

[0148] The at least one electronic component may be mounted using an adhesive, such as, for example, an adhesive tape or pad. By using an adhesive for mounting the at least one electronic component, a highly precise positioning may be achieved. Thereby, a performance of the at least one sensor, for example, in terms of acquiring sensor data and / or of the at least one feedback component (e.g., providing mechanical feedback by means of at least one actuator) may be improved.

[0149] A minimal wall thickness of the skirt portion may be in the range between 0.5 mm and 1.5 mm, preferably below 1 mm (e.g., between 0.5 mm and 1 mm). Alternatively, or in addition, a minimum thickness of the outer surface, such as, the surface made from the second material may be in the range between 0.5 mm and 5 mm in areas that do not cover electronic components, and / or between 0.5 mm and 2.5 mm in areas that cover electronic components. The material thickness of both each of the layers of the first and second material as well as the total thickness of the material ofthe smart dental device may be selected based on requirements, such as the mechanical stresses that may occur in the relevant area, mechanical properties the dental device may need to fulfill, such as, for example, tension that needs to be maintained in a retention splint, the position, etc. For example, it is generally not wished, and may not be necessary at all, to design the device having a thick material layer in the frontal teeth portion, however, it is uncritical to have a thick material layer (including electronic components, etc.) in the buccal portion ofthe device. Accordingly, the material layers may be chosen to have different dimensions along and / or across the entire smart dental device.

[0150] Taken the two layers together, i.e., the second material covering the first material, the facial labial (also: facial anterior) portion as well as the lingual portion of the smart dental device may be kept as thin as possible, for example, below 1.5 mm.

[0151] The facial buccal portion and occlusal portion may have less than (or at most) 4 mm thickness in total (excluding a recess, pocket, pouch and / or void for the at least one electronic component). Some areas of the smart dental device may be having a thicker material layer than others on purpose to create a seamless and rounded transition to the extrusions (e.g., enclosing a recess, pocket, pouch and / or void) where the electronic components are embedded in.

[0152] In the posterior occlusal portion, the thickness of the material layer may be preferably below 2 mm.

[0153] The skirt portion manufactured from the first material and the portion moulded from the second material may be connected by a positive fit and / or a material bond (i.e., a material fit).

[0154] Printed dental resins, such as (e.g., meta)-acrylates for the first material may be used with 2K or photoinitiated acrylate dental products (such as BMS 016, Dentamid fixtemp, and / or Dentamid FotoDent) for the second material. Alternatively, or in addition, apolar first materials like COPs might bond well to apolar second materials (such as COP and others). COPs can be formulated at different hardness levels for the first and second material. Further alternatively or in addition, printed nylons (e.g., polyimide) for the first material may be used with a heat-curing polyimide resin (e.g., as the second material).

[0155] This way, the at least one electronic component may be enclosed in an airtight and / or waterproof manner within the smart dental device.

[0156] A covalent bonding may be facilitated by activation of the surface of the first material by a Corona, Plasma, or other surface treatment that generates functional groups on the surface. This may be done before the mounting (also: electronic placement) with shielding of the (e.g., sensitive) electronic components, or with another process that is compatible.

[0157] The skirt portion manufactured from the first material and the portion moulded from the second material may be connected in a sealed configuration. For example, the skirt portion manufactured from the first material and the portion moulded from the second material may be connected in a fluid-tight and / or airtight configuration. Thereby, the at least one electronic component may be sealed against ingress of fluid such as saliva, water or air.

[0158] The fluid tight and / or airtight sealing of the at least one electronic component can facilitate a long lifetime of the at least one electronic component and / or can ensure that the at least one electronic component is not corrupted by oxidation. Alternatively, or in addition, the fluid tight and / or airtight sealing of the at least one electronic component can ensure that potentially poisonous material (e.g., comprised in the energy storage unit) does not leak into the person’s oral cavity.

[0159] In the third device aspect of the invention, a smart dental device is provided. The smart dental device may be manufactured using the method according to the third method aspect of the invention. Hence, the smart dental device may be manufactured according to a smart dental device digital data set. The smart dental device digital data set may comprise the skirt portion digital data set and the mould portion digital data set. Alternatively, or in addition, the smart dental device digital data set may also comprise an arrangement of the at least one electronic component.

[0160] The smart dental device may be a smart dental treatment device. The smart dental treatment device may be an occlusal splint (e.g., a Michigan splint), or another flat-plane bite splint. Alternatively, or in addition, the smart dental treatment device may be a guard (e.g., an alignerlike guard, a sport guard, and / or a night guard). Alternatively, or in addition, the smart dental treatment device may be a retainer. Further alternatively or in addition, the smart dental treatment device may be a dental brace. Still further alternatively or in addition, the smart dental treatment device may be an anti-snoring device and / or a mandibular advancement device. The smart dental device may comprise a skirt portion according to the first device aspect comprising a first material. The smart dental device may further comprise at least one electronic component mounted on the one or more mounting surface portions of the skirt portion, for example, defined by the digital data set. The smart dental device may further comprise an outer geometry portion comprising a second material for substantially matching an occlusal surface of the person’s opposite occlusal dental surface topology. The first material and the second material may be connected in a fluid-tight and / or gas tight configuration. Thereby, the at least one electronic component, however, not necessarily all electronic components, may be sealed against ingress of fluid such as saliva, water or gas.

[0161] Any one of the methods according to the first, second and / or third method aspect may be performed in a laboratory, such as s dental laboratory and / or manufacturing workshop. Alternatively, or in addition, the outer geometry of the workpiece (i.e., the smart dental device) may be manually fine-tuned and / or polished by a specialist, such as, a dentist and / or a dental technician.

[0162] The invention also provides a computer-program product. The computer-program product comprises program elements which induce a manufacturing device to carry out the steps of the method for manufacturing a customized smart dental device tightly fitting at least a facial, lingual and / or occlusal dental surface topology of a person according to the method aspect, when the program elements are loaded into a memory of the manufacturing device.

[0163] The invention also provides a computer-readable storage medium, or a carrier wave, storing or encoding program elements that can be read and executed by a manufacturing device to perform steps of the method for manufacturing a customized smart dental device tightly fitting at least a facial, lingual and / or occlusal dental surface topology of a person according to the method aspect, when the program elements are executed by the a manufacturing device.

[0164] Brief Description of the Drawings

[0165] Exemplary non-limiting embodiments are described with reference to the accompanying drawings in which: Fig. 1 shows an exemplary flowchart of a method for manufacturing a skirt portion of a customized smart dental device for a person;

[0166] Fig. 2 shows a first exemplary elevational cross-section of a skirt portion customized to match a facial, lingual and / or occlusal dental surface topology of a person, e.g., manufactured according to the method of Fig. 1;

[0167] Fig. 3 shows an exemplary flowchart of a method for manufacturing a mould portion for manufacturing a customized smart dental device for a person;

[0168] Fig. 4 shows a first exemplary elevational cross-section of a mould portion, e.g., manufactured according to the method of Fig. 3;

[0169] Fig. 5 shows an exemplary flowchart of a method for manufacturing a customized smart dental device for a person by using a skirt portion (e.g., the skirt portion of Fig. 2) and a mould portion (e.g., the mould portion of Fig. 4);

[0170] Fig. 6 shows an exemplary elevational cross-sections of a skirt portion, e.g., the skirt portion of Fig. 2, with mounted electronic components and mounted mould portion, e.g. the mould portion of Fig. 4, as an intermediary manufacturing step of the method of Fig. 5;

[0171] Fig. 7 shows a first exemplary elevational cross-section of a smart dental device, e.g., manufactured according to the method of Fig. 5, and / or after removing the mould portion from the arrangement of Fig. 6;

[0172] Fig. 8 shows a second exemplary elevational cross-section of a skirt portion customized to match a facial, lingual and / or occlusal dental surface topology of a person, e.g., manufactured according to the method of Fig. 1;

[0173] Fig. 9 shows an exemplary elevational cross-sections of a skirt portion, e.g., the skirt portion of Fig. 8, with mounted electronic components and mounted mould portion, e.g., manufactured according to the method of Fig. 3, as an intermediary manufacturing step of the method of Fig. 5;

[0174] Fig. 10 shows a second exemplary elevational cross-section of a smart dental device, e.g., manufactured according to the method of Fig. 5, and / or after removing the mould portion from the arrangement of Fig. 9; Figs. 11 shows a third exemplary elevationa I cross-section of a smart dental device, e.g., manufactured according to the method of Fig. 5;

[0175] Fig. 12 shows an exemplary planar cross-section of a smart dental device, e.g., the smart dental device of Figs. 11, and / or manufactured according to the method of Fig. 5;

[0176] Fig. 13 shows an exemplary perspective view of electronic components mounted on a skirt portion accordingto an intermediary manufacturing step of the method of Fig. 5;

[0177] Fig. 14 shows exemplary electronic components with electric connections having a meandering form;

[0178] Figs. 15A, 15B and 15C show an exemplary perspective view of a skirt portion, a first exemplary support structure for manufacturing the skirt portion and a second exemplary support structure for manufacturing the skirt portion, respectively;

[0179] Fig. 16 shows an elevational cross-sectional view of an exemplary smart dental device mounted on a person’s teeth;

[0180] Fig. 17 shows a perspective view of a person’s dental surface topology with a planned coverage by the smart dental device; and

[0181] Figs. 18 and 19 show exemplary non-smart dental devices, such as splints, manufactured with support structures known in the prior art.

[0182] Detailed Description

[0183] The present disclosure details exemplary embodiments of a technique for manufacturing a customized smart dental device.

[0184] Fig. 1 shows an exemplary flowchart of a method for manufacturing a skirt portion of a customized smart dental device for a person. The method is generally referred to by the reference sign 100.

[0185] The method 100 further comprises a step S104 of controlling an additive manufacturing device to additively manufacture, using a first material, a skirt portion. The skirt portion has an inner surface contour matching the facial, lingual and / or occlusal dental surface topology. The skirt portion further has an outer surface contour comprising one or more mounting surface portions for mounting at least one electronic component. The skirt portion still further has at least one skirt-side sealing structure.

[0186] The method 100 may comprise a step S102 of loading the skirt portion digital data set into a memory of a (e.g., additive) manufacturing device.

[0187] The method 100 may comprise a step S103 of providing a support structure for additively manufacturing S104 the skirt portion. Optionally, the support structure may be meltable or dissolvable for additively manufacturing S104 the skirt portion.

[0188] The method 100 may further comprise a step S105 of removing the support structure of the skirt portion additively manufactured S104 according to the skirt portion digital data set. Optionally, the support structure may be removed by milling, grinding, cutting or other subtractive processes.

[0189] The step S105 of removing the support structures may be performed manually and / or using a robotic device.

[0190] Fig. 2 shows an exemplary elevational cross-section of a skirt portion 200. The skirt portion may be (e.g., additively) manufactured using a first material. The skirt portion 200 comprises an inner surface contour 212 and an outer surface contour 214. The inner surface contour 212 (also: tooth contact side of appliance material) is configured to tightly fit a person’s facial, lingual and / or occlusal dental surface topology.

[0191] The skirt portion in Fig. 2 further comprises a mounting surface portion (e.g., in the shape of a pouch) 216 for one or more electronic components. At reference sign 218, a skirt-side sealing structure is indicated. At reference sign 220, a skirt-side boundary of a mould cavity is schematically depicted.

[0192] The skirt portion (also: “first 3D printed part”) may be additively manufactured or (e.g., 3D) printed, in particular, using a first material. The first material may be a hard material (e.g., Keysplint hard) or a soft material (e.g., Keysplint soft). With the first printing or additive manufacturing step, a filling form (also: mould; e.g., with a partly standardized outer format), in particular defining a mould cavity, may be manufactured in two pieces. The second piece may be formed by the mould portion. The standardized outer format may, in particular, refer to an outer shape ofthe mould portion.

[0193] Any support structures (also: printing supports) used for the manufacturing ofthe first 3D printed part may be removed after the additive manufacturing (and / or 3D printing) is finished.

[0194] Fig. 3 shows an exemplary flowchart of a method for manufacturing a mould portion for manufacturing a customized smart dental device for a person. The method is generally referred to by the reference sign 3OO.The method 300 comprises a step S304 of controlling a (e.g., additive) manufacturing device to (e.g., additively) manufacture, using a mould forming material a mould portion. The mould portion has an inner surface contour configured to match at least the occlusal shape of the opposing dental arc of the person. The mould portion further has at least one mouldside sealing structure. The mould-side sealing structure defines a boundary line of the mould cavity formed by at least a part of the inner surface contour of the mould portion as a portion of the inner mould cavity contour.

[0195] The method 300 may comprise a step S302 of loading the mould portion digital data set into a memory of a (e.g., additive) manufacturing device.

[0196] Fig. 4 shows an exemplary elevational cross-section of a mould portion 400. The mould portion 400 comprises an inner surface contour 412, which at least partially forms a mould-side boundary of a mould cavity. The mould portion 400 further comprises an outer surface 414, one or more fluid-connecting runner channels 416, through which the mould cavity filling material may be inserted into the mould cavity, and a mould-side sealing structure 418.

[0197] The outer surface contour has an inlet connector structure 415 shaped to ensure a secure connection between the mould portion 400 and a mould fluid source during the filling (or infiltration) of the mould cavity usingthe mould filling material. The connector structure 415 may be shaped to ensure the connection is retained even if significant pressure us applied to the mould filling material during the filling process.

[0198] Fig. 5 shows an exemplary flowchart of a method for manufacturing a customized smart dental device for a person by using a skirt portion (e.g., the skirt portion 200) and a mould portion (e.g., the mould portion 400). The method is generally referred to by the reference sign 500. The method 500 comprises a step S502 of mounting at least one electronic component on the one or more mounting surface portions of the outer surface contour of the skirt portion (e.g., the skirt portion 200).

[0199] The step S502 of placing the electronic components may be performed manually and / or using a robotic device. Alternatively, or in addition, the electronic components may, e.g., be mounted using an (e.g., frictional) adhesion (and / or non-positive fit).

[0200] The method 500 further comprises a step S504 of mounting the mould portion (e.g., the mould portion 400) to the skirt portion (e.g., the skirt portion 200) comprising the mounted S502 at least one electronic component for defining a mould cavity. The mounting S504 comprises engaging sealingly the at least one sealing skirt-side sealing structure of the skirt portion (e.g., the skirt portion 200) with the at least one mould-side sealing structure of the mould portion (e.g., the mould portion 400).

[0201] The method 500 further comprises a step S506 of filling the mould cavity with a mould cavity filling material (also: second material).

[0202] The method 500 still further comprises a step S508 of removing S508 the mould portion (e.g., the mould portion 400).

[0203] The method 500 may comprise a step S507 of setting the filling material or allowing the filling material to set, thereby creating an occlusal portion of the smart dental device fluid-tightly embedding the at least one electronic component.

[0204] The smart dental device may be manufactured by means of CAD / CAM. E.g., the steps of the method of Fig. 5 may be performed using CAM.

[0205] Fig. 6 shows a skirt portion 200 with a mounted mould portion 400. Before mounting the mould portion 400, electronic components 630-1 and 630-3 have been mounted (also: placed) at a facial side (e.g., comprising a microprocessor, energy storage unit, sensor, and / or antenna) and at an occlusal side (e.g., comprising one or more sensors, in particular a pressure sensor and / or force sensor), respectively, connected by an electrical connection 630-2 as a furth electronic component. Alternatively, or in addition, the electronic components (e.g., comprising sensors) 630-1; 630-2; 630-3 may be fixed in place, e.g., using shape conformal adhesive tape. The mould cavity in Fig. 6 is filled with mould cavity filling material (e.g., second material) 602, whereby a smart dental device 600 covered by the mould portion 400 is obtained. The mould cavity filling material (e.g., second material) 602 may, e.g., be a hard-acrylic material.

[0206] In Fig. 7, the smart dental device 600 of Fig. 6 is shown with its outer occlusal surface 612. The outer occlusal surface 612 in Fig. 7 is matching the inner surface contour 412 of the mould portion 400 of Fig. 6.

[0207] In connections with the skirt portion 200 of Fig. 2, the mould portion 400 of Fig. 4, the filled mould cavity of Fig. 6 and the smart dental device 600 of Fig. 7, the manufacturing (e.g., using the methods 100; 300 and 500) may be described as follows. The skirt portion 200 may be (e.g., additively) manufactured (also: 3D printed) and postprocessed.

[0208] Electronic components (e.g., 630-1; 630-2; 630-3), e.g., comprising at least one sensor, may be inserted and / or mounted, in particular, on the mounting surface portions 216, which may comprise (e.g., pre-printed) recesses, indentations and / or pouches. A support structure and / or connection elements may be made use of.

[0209] The mould portion 400 may be (e.g., additively) manufactured (also: 3D printed), in particular, independently of the (e.g., additively) manufacturing of the skirt portion 200. In one example, the mould portion 400 may be printed starting from the mould-side sealing structure 418 and the inner surface contour 412.

[0210] The mould portion 400 may be assembled, as exemplified in Fig. 6, on top of the skirt portion 200, onto which the electronic components 630-1; 630-2; 630-3 are mounted, with their respective sealing structures 218; 418 sealingly engaging with each other. A tightness of the sealingly engaging may be improved by applying pressure on the mould portion 400.

[0211] The mould cavity filling material (e.g., second material) 602 may then be inserted through the central fluid runner channel (also denoted as injection ports and / our outlets) 416 in Fig. 6. Through the sidewise oriented fluid runner channels 416 in Fig. 6, air may escape during the filling of the mould cavity with mould cavity filling material 602. At the skirt-side boundary 220 of the mould cavity, a bonding agent may be applied before filling the mould cavity with the mould cavity filling material. Alternatively, or in addition, at the inner surface contour 412 of the mould portion 400, a mould release agent may be applied before filling the mould cavity with the mould cavity filling material. Thereby, the bonding between the first material and the second material of the smart dental device 600 may be improved. Alternatively, or in addition, it may be ensured that the first material and the second material of the smart dental device 600 remain bonded when removing the mould portion 400 after filling the mould cavity with the mould cavity filling material (and / or the second material) 602.

[0212] When filling in the mould cavity filling material 602, a form fit (and / or positive fit) may be achieved. A temperature during the filling (e.g., a temperature of the second material) may be regulated to avoid bubble formation as well as for avoiding damage to the electronic components.

[0213] When removing the mould portion 400 after filling the mould cavity with the mould cavity filling material (and / or the second material) 602 to obtain the smart dental device 600, as schematically shown in Fig. 7, a burr (also: ridge) may remain at the transition from the first material to the second material. The burr (also: ridge) may be removed, and / or a fine-tuning of the customized smart dental device 600 may be performed, e.g., by means of abrasing (e.g., manually and / using a dental burr).

[0214] A relatively soft first material can allow for easy fitting and / or a comfortable fit over a longer period time (e.g., a night) of the smart dental device to the person’s dental surface topology.

[0215] The first material and the second material are advantageously chosen such that they bond well physically and / or chemically with each other. Alternatively, or in addition, bubbles are avoided in the manufacturing process of the smart dental device, e.g., due to suitable choices of the first and second materials.

[0216] Exemplary biocompatible materials, which may be used as first material and / or as second material are provided below in Table 1 along with their known physical properties such as elastic modulus (briefly: E-modulus), shore hardness and tensile strength.

[0217] Any one of the manufacturing of the skirt portion, of the mould portion and of filling the mould cavity may make use of customized vacuum casting. In particular, filling the mould cavity may make use of vacuum casting. The customizing may relate to the shape of the mould cavity.

[0218] Any electronic component may be mounted using a pouch and / or pocket.

[0219] The first material used for the skirt portion and the mould cavity filling material (and / or second material) may be selected for compatibility, e.g., in view of expanding (such as under temperature changes) and / or for bonding. In one embodiment, the smart dental device may cover essentially the full arch of a jaw. In this case, an electronic connection may need to be extended along the incisal section. In an alternative embodiment, the smart dental device may only cover a buccal section (e.g., only at one side or on both sides). In any embodiment, any extended electronic component (e.g., a microprocessor, energy storage unit, and / or sensor) may be located in the buccal section, at the facial surface and / or at the occlusal surface.

[0220] When filling the mould cavity with the mould cavity filling material, the electronic components (e.g., mounted in a pouch or pocket) may be sealed in a fluid-tight (in particular, watertight) manner.

[0221] The mould cavity filling material may be abrased and / or fine-tuned after filling the mould cavity and hardening the mould cavity filling material. Alternatively, or in addition, any burr, such as due to protrusions in the skirt portion for fixing the mould portion in the correct position, may be abrased.

[0222] In one embodiment, a skirt portion (and / or first 3D printed part) is made to fit the maxillary arch. This may be done with a H / S material (such as KeySplint soft) or with a hard material (such as Keysplint hard). The H / S material on the inside has the advantage of easy fitting. The electronic components (e.g., sensors and electronics) are placed on the skirt portion (and / or on the first 3D printed part). E.g., the sensors may be fixed in place with shape conformal an adhesive tape. Fixing the electronic components (e.g., the sensors) in place may be the only manual step when manufacturing the smart dental device.

[0223] The buccal space with the electronic components may be filled first to secure the placement of the electronic components. Thereby, later filling problems can be avoided.

[0224] A mould portion (and / or a second 3D printed counterpart) may be placed on the skirt portion (and / or the first 3D printed part) with the electronic components mounted, and optionally secured in place. The inner side of the mould portion (and / or the second 3D printed counterpart) is preferrably customized. The outer part of the mould portion may be a standard format with fixed positions for the fluid-connecting runner channels (and / or material injection ports).

[0225] The mould cavity filling material (and / or the second material) may be selected to bond well to the first material of the skirt portion (also: the print). When filling the mould, the formation of bubbles may be avoided. The smart dental device (e.g., splint) may be completed by filling the customized top-mould, e.g., with a hard acrylic material. A hard flat plane may be manually adjusted (e.g., by a dentist and / or a dental technician).

[0226] Fig. 8 schematically shows a further skirt portion 200. The skirt portion 200 of Fig. 8 comprises optional protrusions 216-P (also: spacers) of the mounting surface portion 216 (e.g., at the facial side) and protrusions 218-P (also: support) of the skirt-side sealing structure. The protrusions 218-P of the skirt-side sealing structure may be removed (also: sacrificed, e.g., abrased) later, e.g., for fine-tuning the outer shape of the customized smart dental device.

[0227] The optional protrusions 216-P (also: spacers) of the mounting surface portion 216 enable a filling with the mould cavity filling material (and / or the second material), in particular, a hard material, to envelop the electronic component 630-3 (e.g., comprising a PCB). Thereby, the electronic component 630-3 may be protected from mechanical stress and / or damage.

[0228] The skirt portion 200 may be manufactured (e.g., 3D printed) using a relatively soft (also denoted as hard-soft, H / S) material, whereby the inner side of the smart dental device remains flexible.

[0229] Fig. 9 schematically depicts a mould portion 400 mounted on the skirt portion 200 of Fig. 8. The protrusions 218-P (also: sacrificial support) of the skirt-side sealing structure are used to accurately place the mould portion 400 relative to the skirt portion 200. As schematically illustrated, the skirt portion 200 and mould portion 400 together form a customized (in particular, to a person, e.g., a patient) mould (e.g., a manufactured, such as 3D printed, mould), which may have at least partially standard outer dimensions (e.g., as schematically illustrated by the rectangular outer shape of the mould portion 400).

[0230] In the schematic example of Fig. 9, three electronic components 630-1; 630-2; 630-3, which have been mounted on the skirt portion 200 before mounting the mould portion 400, are shown.

[0231] Fig. 10 schematically illustrates the smart dental device 600 after the mould cavity filling material 602 is hardened and the mould portion 400 is removed. In the example of Fig. 10, the facial side with the electronic component 630-1 is wider than the lingual side, which in the exemplary embodiment is formed only from the skirt portion 200 (and / or the first material).

[0232] Fig. 11 shows an elevational cross-sectional view of an exemplary customized smart dental device 600. The customized smart dental device 600 of Fig. 11 may, e.g., be obtained by the method 500 of Fig. 5. At reference sign 606, an exemplary height of the second material on the occlusal side (e.g., at a position towards the facial side) of the smart dental device 600 is shown. The height 606 may be manually adjustable, such as by using a dental burr (e.g., for fine-tuning the height after milling, in particular, also allowing the height to vary across the occlusal surface, in particular to improve a bite comfort with the opposite occlusal dental surface topology).

[0233] At reference sign 604, an exemplary width of the second material covering the electronic component 630-1 placed at the facial side of the smart dental device 600 is shown.

[0234] The first material forming the skirt portion 200 and the second material (which, in particular, provides the occlusal surface of the customized smart dental device) may be physically and / or chemically bonded.

[0235] In any embodiment, any (e.g., the occlusal) side of the smart dental device 600 can be adjusted manually, such as by a dental burr.

[0236] Fig. 12 shows a planar cross-sectional view of an exemplary customized smart dental device 600 (e.g., the same device 600 as shown in Fig. 11). Arranged on top of the skirt portion 200 are electronic components (e.g., sensors such as sensor pads) 630-3 at the occlusal side, with electronic components (e.g., a microprocessor, energy storage unit, antenna, and / or further sensors such as sensor pads) 630-1 placed at each facial buccal side, and the electronic components 630-1; 630-3 connected by electrical connections 630-2, which reach around the facial labial side to both facial buccal sides.

[0237] A variable thickness of the second material is exemplarily indicated at the left facial buccal side by the reference sign 604.

[0238] As schematically indicated in Fig. 12, a lingual thickness of the second material may optimally be as thin as possible, in particular, near zero at an incisal (also: labial and / or front teeth) section 258 (also: anterior end). The second material 602 is alternatively or in addition chosen sufficiently thick to protect any one of the electronic components, e.g., the electrical connections 630-2 (e.g., along the facial labial and / or facial buccal sections) and the electronic components 630-1 arranged on the facial buccal sides of the buccal section 256 (also: posterior end). Protection comprises protecting against fluid (e.g., water and / or saliva) ingress and / or mechanical damage. Fig. 13 shows an exemplary perspective view of a skirt portion 200 with mounted electronic components 630-1; 630-2; 630-3; 630-4. The example shown in Fig. 13, in particular, includes further electronic components 630-4 at the lingual surface (e.g., one or more sensor, in particular pressure sensors and / or force sensors, and / or circuit components, such as energy storage unit and / or microprocessor).

[0239] In one embodiment, the perspective view of Fig. 13 shows a skirt portion 200 ranging only from the buccal section 256 to the incisal section 258 on one facial side of the person. In an alternative embodiment, the perspective view of Fig. 13 shows only a part of the skirt portion 200 ranging only from the buccal section 256 to the incisal section 258, with another part of the skirt portion 200 extending along the opposite facial side of the person.

[0240] Any one of the electronic components (e.g., sensors and / or circuit components) 630-1; 630-2; 630-3; 630-4 may be flexible and / or rigid (e.g., independently per component).

[0241] In Fig. 13, the electronic component 630-1 is exemplarily positioned and / or fixed using an adhesive (e.g., adhesive tape) 632.

[0242] The exemplarily shown mounting surface portion 216 may comprise an indentation, a protrusion, recess, or any other position aid formed to guide the placement of the electronic component (e.g., 630-1).

[0243] Fig. 14 exemplarily shows an ensemble of electronic components 630-1; 630-2; 630-3; 630-4. In the example, facial side electronic component 630-1 (e.g., comprising the energy storage unit and microprocessor) is connected by electric connections 630-2 to electronic components 630-3 and 630-4 at the occlusal and lingual sides, respectively.

[0244] The electric connections (also: conductors) 630-2 in the example of Fig. 14 are realized in meandering form, allowing for stretching among the electronic components (also: substrates) 630-1; 630-3; 630-4. Thereby, it is possible to use a standard ensemble and customize its positioning to fit the size and shape of the customized smart dental device.

[0245] Fig. 14 exemplarily shows an ensemble of electronic components 630-1; 630-2; 630-3; 630-4 installable on one (e.g., facial) side of the person’s mouth. Further electronic components (not shown) may be connected on the other (e.g., facial) side of the person’s mouth. Any one of the electronic components (also: substrates) 630-1; 630-3; 630-4 may be formed as a pad, such as a sensor pad.

[0246] Fig. 15A provides a simplified perspective view of a skirt portion 200, with Figs. 15B and 15C showing different types of support structures for additive manufacturing of the skirt portion 200 in an elevational cross-sectional view.

[0247] In Fig. 15B, a (e.g., meltable and / or dissolvable) support structure 240 (also denoted as sacrificial support) is provided at the inside of the inner surface contour 212 of the skirt portion 200. The (e.g., meltable and / or dissolvable) support structure 240 (e.g., comprising a support structure material different from the first and second material) may be provided before manufacturing the skirt portion 200 using the first material.

[0248] Using the support structure 240 may be denoted as using an inversed printing direction. The support structure 240 may be first produced as support from the inner surface contour 212 of the skirt portion 200. The support structure 240 may be sacrificed, e.g., by melting and / or dissolving, after the skirt portion 200 has been printed. The wall thickness of the skirt portion 200 may be manufactured location-specific and may (at least in some cases) require additional support (e.g., due to the bent shape of the skirt portion 200).

[0249] The printing (and / or additive manufacturing) direction of a multi-material printing (and / or additive manufacturing) in Fig. 15B may be from bottom to top.

[0250] In Fig. 15C, a support structure 242 is provided at the outer surface contour 214 of the skirt portion 200. The support structure 242 may be additively manufactured along with the skirt portion 200, e.g., also using the first material.

[0251] The printing (and / or additive manufacturing) direction according to Fig. 15C may be from top to bottom.

[0252] In particular, in sections of the skirt portion 200, where the first material is designed to be (e.g., critically) thin, a suitable support may be required, e.g., with a larger density of support structures 242.

[0253] Fig. 16 shows a further exemplary elevational cross-sectional view of a smart dental device 600 arranged over a person’s dental topology (briefly also: tooth). The smart dental device 600 in Fig. 16 comprises an electronic unit 630-1 as electronic component at the facial side. The electronic unit 630-1 comprises an energy storage unit 630-1A (and / or an energy magnet and / or an optical energy storage), a microprocessor 630-1B and an antenna 630-1C (e.g., a communication IC, integrated chip, antenna).

[0254] At reference sign 260, an undercut area with an opening angle (e.g., a) is shown. In the undercut area 260, the person’s dental surface topology is reduced. This may pose a problem if the smart dental device 600 (e.g., its skirt portion) is configured to reach very low, as the reduced width hinders pulling on and pulling of the smart dental device 600.

[0255] The smart dental device (e.g., splint) 600 may have a hard outer surface (e.g., oriented towards the opposite occlusal surface topology) composed of the second material for durability. The hard outer surface may, optionally, be adjusted manually and / or by a dentist (and / or a dental technician) to optimize the occlusion.

[0256] Optionally, the advantages of a hard-soft appliance may be combined with those of a hard- acrylic dental device (e.g., splint). The smart dental device (e.g., splint) 600 may be soft on the inside (e.g., the first material may be soft), in particular, for comfort and easy fit. Alternatively, or in addition, the smart dental device (e.g., splint) 600 may have a durable outer surface (e.g., the second material may be durable) that can be adjusted by the dentist (and / or a dental technician) and that may, e.g., serve as occlusion stabilization splint. E.g., the first material may be a thermoflex or thermoplastic material that becomes soft at warm-water temperatures around 50°C.

[0257] The smart dental device (e.g., splint) 600 may be configured for good retention, e.g., due to the possibility of having small undercuts 260 as exemplified in Fig. 16.

[0258] The smart dental device (e.g., splint) may be enabled for communication with an external device (e.g., a base-station, smartphone and / or PC). The external device may, e.g., be owned (and / or be intended for use) by the person for whom the smart dental device is customized. Alternatively, or in addition, the external device may be owned (and / or be intended for use) by the medical practitioner (e.g., dentist, sleep specialist, and / or a neurologist) treating the person.

[0259] Optionally, the smart dental device (in particular, its energy storage unit) may be charged wirelessly. The smart dental device (e.g., splint) may have one or more electronic components (and / or sensors) along the buccal, lingual, occlusal, incisal and / or labial side.

[0260] The first material and the second material may be chosen to protect sufficiently well from fluid (e.g., water and / or saliva) ingress for at least four weeks, preferable for at least two years and even more preferably for more than five years.

[0261] In some embodiments, at least one of the (e.g., embedded) electronic components may be configured for detecting fluid (e.g., water and / or saliva) ingress.

[0262] The one or more sensors may comprise (e.g., one or more) pressure sensors, force sensors, temperature sensors, motion sensors, biosensors, sound sensors, ultrasound sensors, oxygen saturation sensors, optical sensors, pH and / or ion sensors, humidity sensors, ECG sensors, respiration sensors, cameras, heart rate sensors, blood pressure sensors, EEG sensors, and / or IR sensors.

[0263] Fig. 17 shows an exemplary contour line or undercut line (and / or undercut area) 662, which marks an area to which level the smart dental device needs to be designed. E.g., for good retention, the lower boundary of the smart dental device is ideally placed slightly beneath undercut line 662. By the undercut line 662 and / or the lower boundary of the smart dental device, an (e.g., minimal or maximal) extension of a vertical space 664 for placing electronic components 630-1; 630-4 is defined.

[0264] Fig. 18 shows an example of a non-smart splint additively manufactured using support structures 242’ on the outer surface according to the prior art.

[0265] Fig. 19 shows an example of a further additively manufactured non-smart splint according to the prior art, in which an outer shape of the additive manufacturing is defined as a circle and the additively manufactured splint is held by bridges 242’ as support structures.

[0266] In both prior art examples of Figs. 18 and 19, no electronic components and no manufacturing using two (in particular, a first and second) material are foreseen.

[0267] The manufacturing of the customized smart dental device can be automated to a large degree (e.g., up to a final manual finish of the occlusal surface), e.g. using CAD / CAM. By the manufacturing method, a customized smart dental device (e.g., splint) may be produced that comprises two (e.g., the first and second) materials, which can harness the advantageous features of being hard-soft on the tooth side for comfort and easy fit and being hard and flat on the occlusal side for durability and with freedom to adjust by the dentist (and / or a dental technician).

[0268] Advantageously, the first material and the second material may be selected to be two perfectly bondable materials.

[0269] The customized smart dental device (e.g. splint) may comprise a hard, grindable (and / or adjustable) surface on the outside and a soft and / or hard-soft inner surface.

[0270] A customized smart dental device (e.g., splint) may be manufactured using an overmould to seal electronic components (e.g., comprising sensors) and close the customized smart dental device (e.g., the splint).

[0271] The design of the smart dental device may, e.g., comprise a skirt portion digital data set for use in manufacturing the skirt portion. Alternatively, or in addition, the person’s facial, lingual and / or occlusal dental surface topology for the mandible (also: lower jaw) and / or maxilla (also: upper jaw), and / or the person’s occlusion may be obtained by means of an intraoral (IO) scan. E.g., based on the IO scan, a CAD design may be performed to determine the shape and size of the skirt portion (e.g., including positions of the one or more mounting surface portions) and the mould portion, and optionally a (e.g., final) shape ofthe smart dental device after fine-tuning (and / or milling). Alternatively, or in addition, a positioning of support structures (e.g., relative to a tooth contact surface portion and / or a mounting surface portion) may be determined by the (e.g., CAD) design. Further alternatively or in addition, an optimal positioning ofthe mould portion relative to the skirt portion (e.g., by means of including registration marks or registration pins in the design) may be achieved by the (e.g., CAD) design.

[0272] Fine-tuning may comprise clipping of the form and / or polishing ofthe customized smart dental device.

[0273] A mould (e.g., comprising the skirt portion and the mould portion) may be (in particular, additively) manufactured (and / or 3D printed) and include a match to the person’s dental surface topology (and / or tooth contact side that conforms to a person’s maxillary or mandibular dental arch, or at least a portion thereof).

[0274] The mould (e.g., comprising the skirt portion and the outer mould contour) my further include a second side opposite the tooth contact side. The second side may form at least part of a wall of a mould cavity (also: fillable cavity).

[0275] Optionally, the mould may include registration features (e.g., one or more registration marks and / or registration pins) for use of registering the position of the moulded workpiece (and / or moulded part) in subsequent machines (e.g., a milling device) in the manufacturing process.

[0276] Optionally, the mould includes one or more mounting surfaces (e.g., indents and / or cavities) on the inner surface of the mould cavity (also: fillable cavity) corresponding to locations for placement of at least one electronic component (also: electronic device).

[0277] The at least one electronic component (also: electronic device; e.g., one or more sensors) may be placed on the outer surface contour of the skirt portion (also: surface of portions of the second side) within the mould cavity (also: fillable cavity of the mould).

[0278] The mould cavity (also: fillable cavity of the mould) may be filled with a second (e.g., hard millable) material.

[0279] Once hardened, the second (e.g., hardened millable) material may be fine-tuned (such as milled) within the mould cavity to conform to the (e.g., desired) outer geometry of the smart dental device, in particular, for matching the person’s opposite dental surface topology.

[0280] The invention relates to a (in particular, customized) smart dental device (e.g., a smart intraoral splint) with embedded electronic components and a method of manufacture of the (in particular, customized) smart dental device.

[0281] A skirt portion (and / or a first 3D printed part) is made to fit the maxillary or mandibular arch (or at least a portion thereof). The skirt portion (and / or the first 3D printed part) may be manufactured using a relatively soft and / or H / S material (e.g., Key-splint soft), or using a hard material (such as Key-splint hard).

[0282] Electronic components (e.g., sensors and / or other electronics) may be placed on the skirt portion (and / or on the first 3D printed part). Preferably, at least a part of the electronic components (e.g., sensors) may be fixed in place in a shape-conform cavity of the skirt portion (and / or the first 3D printed part). An affixation may be performed using any suitable means, such as adhesive and / or adhesive tape.

[0283] The buccal space (e.g., comprising the mounting surface portions and / or pouches) with the electronic components may be filled first to secure the placement of the electronic components.

[0284] A mould portion (and / or counterpart second 3D printed part) may be formed to be fittedly placed on top of the skirt portion (and / or the first 3D printed part), in particular, after mounting the electronic components, and optionally after having at least partially filled some mounting surface portions and / or pouches for the electronic components. The inner side of the mould portion (and / or the counterpart) may be customized. The outer part of the mould portion may have a standard format with fixed positions for the fluid-connecting runner channel (and / or material injection ports).

[0285] The customized smart dental device (e.g., a splint) may be completed by filling the customized mould cavity (also: top-mould), e.g., with a hard acrylic material.

[0286] A CAD / CAM process can allow to enclose the electronic components (e.g., sensors and electronics), with the sensors particularly also at the occlusion. Two (e.g., additively) manufactured (and / or 3D printed) parts, the skirt portion and the mould portion may be combined. A skirt portion as first part along the tooth contact side of the smart dental device (e.g., splint) and a mould portion as second part may be used to form the mould and / or enclose the mould cavity.

[0287] While the present invention has been described with respect to non-limiting embodiments, it is to be understood that the invention is not limited to the disclosed embodiments. Persons skilled in the art understand that the disclosed invention is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims. Thus, the present invention should not be limited by any of the described embodiments. Individual embodiments, or their individual aspects and features, described in relation to the drawings can be combined or exchanged with one another without limiting or widening the scope of the described invention, whenever such a combination or exchange is meaningful and in the sense of this invention.

[0288] List of Reference Signs 100 Method for manufacturing a skirt portion of a customized smart dental device

[0289] S102 Step of loading a skirt portion digital data set

[0290] S103 Step of providing a support structure

[0291] S104 Step of controlling an additive manufacturing device to additively manufacture a skirt portion

[0292] S105 Step of removing the support structure

[0293] 200 Skirt portion (in particular additively manufactured from 1stmaterial)

[0294] 212 Inner surface contour

[0295] 214 Outer surface contour

[0296] 216 Mounting surface portion for an electronic component

[0297] 216-P Protrusion of the mounting surface portion

[0298] 218 Skirt-side sealing structure

[0299] 218-P Protrusion of the skirt-side sealing structure

[0300] 220 Skirt-side boundary of mould cavity

[0301] 240 Meltable support structure

[0302] 242; Additively manufactured support structure

[0303] 242'

[0304] 256 Buccal section of the smart dental device and / or of the skirt portion

[0305] 258 Labial / incisal section of the smart dental device and / or of the skirt portion

[0306] 260 Undercut area with opening angle

[0307] 300 Method for manufacturing a mould portion for manufacturing a customized smart dental device

[0308] S302 Step of loading a mould portion digital data set

[0309] S304 Step of controlling an additive manufacturing device to additively manufacture a mould portion

[0310] 400 Mould portion

[0311] 412 Inner surface contour

[0312] 414 Outer surface contour

[0313] 416 Fluid-connecting runner channel

[0314] 418 Mould-side sealing structure

[0315] 500 Method for manufacturing a customized smart dental device

[0316] S502 Step of mounting an electronic component

[0317] S504 Step of mounting the mould portion to the skirt portion S506 Step of filling the mould cavity

[0318] S507 Step of setting the filling material

[0319] S508 Step of removing the mould portion

[0320] 600 Smart dental device

[0321] 602 Mould cavity filling material (e.g., 2ndmaterial)

[0322] 604 Width of mould cavity filling material at facial surface

[0323] 606 Height of mould cavity filling material at occlusal surface

[0324] 612 Outer occlusal surface of the smart dental device

[0325] 630-1 Electronic component(s) at facial surface (e.g., microprocessor, energy storage unit, sensor, and / or antenna)

[0326] 630-2 Electronic component, in particular electrical connection

[0327] 630-3 Electronic component at occlusal surface (e.g., sensor, in particular pressure sensor and / or force sensor)

[0328] 630-4 Electronic component at lingual surface (e.g., sensor, in particular pressure sensor and / or force sensor)

[0329] 632 Adhesive (e.g., adhesive tape)

[0330] 662 Undercut line along the person’s dental surface topology

[0331] 664 Available vertical space for electronic components

Claims

Patent Claims1. A skirt portion digital data set for use in manufacturing of a skirt portion of a customized smart dental device, the skirt portion tightly fitting at least a facial, lingual and / or occlusal dental surface topology of a person, wherein the skirt portion digital data set defines: an inner surface contour of the skirt portion customized to match the facial, lingual and / or occlusal dental surface topology, the inner surface contour defining an occlusal surface, a facial surface and a lingual surface, wherein the inner surface contour is configured to form an inner surface of the skirt portion; and an outer surface contour of the skirt portion, wherein the outer contour defines one or more mounting surface portions for mounting at least one electronic component; wherein the outer surface contour of the skirt portion defines at least one skirt-side sealing structure configured to engage sealingly with a mould-side sealing structure of a mould portion, and wherein the skirt-side sealing structure defines a boundary line of a mould cavity defined by at least a part of the outer surface contour of the skirt portion as a portion of the inner mould cavity contour.

2. Skirt portion digital data set according to claim 1, wherein the skirt portion and / or the at least one skirt-side sealing structure is defined to be located at least along a molar sector of the outer surface contour, and optionally, along both molar sectors of the outer surface contour.

3. Skirt portion digital data set according to claim 1 or 2, wherein the at least one skirt-side sealing structure defines at least one protrusion and / or recess configured to sealingly engage with at least one corresponding recess and / or protrusion of the mould-side sealing structure, optionally, wherein the at least one skirt-side protrusion and / or recess is arranged on a facial and / or lingual surface portion of the outer surface contour.

4. Skirt portion digital data set according to any one of claims 1 to 3, further defining at least one skirt-side retention structure configured to interlock with a mould-side engagement structure of a mould portion, enabling a sealing engagement of the skirt-side sealing structure and the mould-side sealing structure of the mould portion, when the skirt-side retention structure and the mould-side engagement structure are arranged in an interlocking engagement.

5. Skirt portion digital data set according to any one of claims 1 to 3, further defining at least one registration mark.

6. Skirt portion digital data set according to any one of claims 1 to 5, further defining at least one support structure facilitating the additive manufacturing of the skirt portion, in particular, wherein the at least one support structure is arranged along an occlusal, facial and / or lingual surface portion of the outer surface contour of the skirt portion.

7. Skirt portion digital data set according to any one of claims 1 to 6, wherein the one or more mounting surface portions define one or more protrusions, one or more indentations and / or one or more cavities, and / or wherein the one or more mounting surface portions are defined to be located on the facial surface and / or in a molar sector.

8. Skirt portion digital data set according to any one of claims 1 to 7, wherein the one or more mounting surface portions define a meandering path for mounting at least one electric lead.

9. Skirt portion digital data set according to any one of claims 1 to 8, wherein the outer surface contour of the skirt portion is defined to have a predefined surface roughness and / or predefined surface features, such as protrusions and / or recesses, for engaging and / or interlocking with a filling material.

10. Skirt portion digital data set according to any one of claims 1 to 9, wherein the person's dental surface topology is selected from the group consisting of: a maxillary dental surface topology; and a mandibular dental surface topology.

11. A skirt portion (200) customized to match a facial, lingual and / or occlusal dental surface topology of a person, wherein the skirt portion (200) comprises: an inner surface contour of the skirt portion customized to match the facial, lingual and / or occlusal dental surface topology of the person, the inner surface contour comprising a surface facing an occlusal dental surface, a surface facing a facial dental surface and a surface facing a lingual dental surface, wherein the inner surface contour forms an inner surface of the skirt portion; and an outer surface contour of the skirt portion, wherein the outer contour comprises one or more mounting surface portions for mounting at least one electronic component; wherein the outer surface contour of the skirt portion comprises at least one skirt-side sealing structure configured to engage sealingly with a mould-side sealing structure of a mould portion, and wherein the skirt-side sealing structure comprises a boundary line of a mould cavity formed by at least a part of the outer surface contour of the skirt portion as a portion of the inner mould cavity contour.

12. A method (100) for manufacturing a skirt portion customized to match a facial, lingual and / or occlusal dental surface topology of a person according to claim 11, comprising the step of controlling a manufacturing device to manufacture (S104) the skirt portion (200) using a first material.

13. Method (100) according to claim 12, wherein the first material comprises a hard material or a soft material, and / or wherein, optionally, the first material is hard at room temperature, medium hard at 37° C and medium soft at warm water temperature of 45° C to 55° C.

14. Method (100) according to claim 12, further comprising the step of: loading (S102) a skirt portion digital data set according to any one of claims 1 to 10 into a memory of the manufacturing device.

15. Method (100) according to any one of claims 12 or 14, wherein the step of manufacturing (S104) the skirt portion comprises additive manufacturing (S104), and wherein the additively manufacturing (5014) further comprises additively manufacturing (S014)::• at least one skirt-side retention structure,• at least one registration mark, and / or• a predefined surface roughness and / or predefined surface features.

16. Method (100) according to any one of claims 12 to 15, wherein the step of manufacturing (S104) the skirt portion comprises additive manufacturing (S104), the method (100) further comprising at least one of the steps of: providing (S103) a support structure for additively manufacturing (S104) the skirt portion, optionally wherein the support structure is meltable or dissolvable for additively manufacturing (S104) the skirt portion; and removing (S105) the support structure of the skirt portion additively manufactured (S104) according to the skirt portion digital data set, and optionally, removing the support structure by milling, grinding, cutting or other subtractive processes.

17. A mould portion digital data set for use in manufacturing of an occlusal portion of a customized smart dental device tightly fitting at least a facial, lingual and / or occlusal dental surface topology of a person, the occlusal portion matching at least an opposing occlusal dental surface topology of the person, wherein the mould portion digital data set defines: an inner surface contour of the mould portion, the inner surface contour of the mould portion customized to match at least the occlusal shape of the opposing dental arc of the person; an outer surface contour of the mould portion, wherein the outer surface contour of the mould portion defines at least one mould-side sealing structure configured to engage sealingly with a skirt-side sealing structure of a surface contour of a skirt portion according to claim 11, and / or as defined by a skirt portion digital data set according to any one of claims 1 to 10, and wherein the mould-side sealing structure defines a boundary line of the mould cavity defined by at least a part of the inner surface contour of the mould portion as a portion of the inner mould cavity contour.

18. Mould portion digital data set according to claim 17, defining at least one fluid-connecting runner system extending from the outer surface contour of the mould portion to the inner surface contour of the mould portion.

19. Mould portion digital data set according to claim 17 or 18, wherein the outer surface contour of the mould portion defines a standardized outer shape, in particular, wherein the standardized outer shape is selected from a group comprising: a circular shape, preferably, having a predetermined radius; and an arched shape, preferably having a predetermined size and a predetermined shape.

20. Mould portion digital data set according to any one of claims 17 or 19, wherein the at least one mould-side sealing structure defines at least one recess and / or protrusion configuredto sealingly engage with at least one corresponding protrusion and / or recess of the skirtside sealing structure, optionally, wherein the at least one mould-side recess and / or protrusion is arranged adjacent to a facial and / or lingual surface portion of the inner surface contour.

21. A mould portion (400) for manufacturing a customized smart dental device for a person, the mould portion comprising: an inner surface contour of the mould portion, the inner surface contour of the mould portion customized to match at least the occlusal shape of the opposing dental arc of the person; an outer surface contour of the mould portion, wherein the outer surface contour of the mould portion comprises at least one mould-side sealing structure configured to engage sealingly with a skirt-side sealing structure of a surface contour of a skirt portion according to claim 11, and wherein the mould-side sealing structure defines a boundary line of the mould cavity formed by at least a part of the inner surface contour of the mould portion as a portion of the inner mould cavity contour.

22. A method (300) for manufacturing a mould portion (400) according to claim 21 for manufacturing a customized smart dental device for a person, comprising the step of: controlling a manufacturing device to manufacture (S304) the mould portion using a mould forming material.

23. Method (300) according to claim 22, further comprising the step of: loading (S302) a mould portion digital data set according to any one of claims 17 to 21 into a memory of the manufacturing device24. Method (300) according to claim 23, wherein the manufacturing (S304) of the mould portion further comprises the step of manufacturing, according to the loaded (S302) mould portion digital data set at least one fluid-connecting runner system.

25. Method (300) according to any one of claims 22 to 24, wherein the mould forming material comprises a hard material.

26. A method (500) for manufacturing a customized smart dental device for a person by using a skirt portion (200) according to claim 11 and a mould portion (400) according to claim 21, comprising the steps of: mounting (S502) at least one electronic component on the one or more mounting surface portions of the outer surface contour of the skirt portion (200); mounting (S504) the mould portion (400) to the skirt portion (200) comprising the mounted (S502) at least one electronic component for defining a mould cavity, wherein the mounting (S504) comprises engaging sealingly the at least one sealing skirt-side sealing structure of the skirt portion (200) with the at least one mould-side sealing structure of the mould portion (400); filling (S506) the mould cavity with a filling material; setting the filling material or allowing the filling material to set, thereby creating an occlusal portion of the smart dental device fluid-tightly embedding the at least one electronic component; and removing (S508) the mould portion (400).

27. Method (500) according to claim 26, wherein the filling material comprises a hard material.

28. Method (500) according to claim 26 or 27, further comprising at least one of the steps of:removing at least one sealing structure of the skirt portion (200), removing at least one retention structure of the skirt portion, removing at least one registration marks, removing at least a part of the mould portion (400), and / or removing at least a part of the occlusal portion of the smart dental device, wherein removal is effected by milling, grinding, cutting and / or other subtractive processes.

29. Method (500) according to any one of claims 26 to 28, wherein the at least one electronic component comprises an energy storage unit, optionally, an electrical energy storage unit, a microprocessor, at least one sensor, optionally, an electrical sensor, connections for providing energy from the energy storage unit to at least the microprocessor and the at least one sensor, wherein, optionally, the energy storage unit is wirelessly rechargeable.

30. Method (500) according to any one of claims 26 to 28, wherein the at least one electronic component further comprises a communication unit, wherein, optionally, the communication unit comprises an antenna for wirelessly transmitting data, the data preferably having been acquired by means of the at least one sensor.

31. Method (500) according to any one of claims 26 to 30, wherein the at least one electronic component further comprises one or more feedback components, the feedback components optionally comprising at least one actuator, for providing feedback to the person responsive to the processing of the sensor data acquired by means of the at least one sensor.

32. Method (500) according to any one of claims 26 to 31, wherein the at least one electronic component is mounted (S106) using an adhesive, in particular, an adhesive tape.

33. A smart dental device (600), wherein the device (600) is manufactured using the method (500) of any one of claims 26 to 32.

34. A transient or non-transient storage medium having information embodied thereon, which, when loaded into a memory of a computer, represent a skirt portion digital data set of any of claims 1 to 10 and / or a mould portion digital dataset of claim 17 to 21.

35. A carrier wave carrying information, which, when loaded into a memory of a computer, represent a skirt portion digital data set of any of claims 1 to 10 and / or a mould portion digital dataset of claim 17 to 21, wherein the information may be embodied in a packeted form or in a stream.

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