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

Abstract

The invention relates to manufacturing a customized smart dental device (200). A digital data set for use in manufacturing of a skirt portion (210) of the dental device (200) is provided. The skirt portion (210) is customized to tightly fit a person's facial, lingual and / or occlusal dental surface topology. The digital data set comprises an inner surface contour (212) of the skirt portion (210) matching the person's occlusal dental surface topology and an outer surface contour (214) of the skirt portion (210) defining mounting surface portions (238) for electronic components. The digital data set further comprises an outer mould contour defining a mould cavity (224). The skirt portion (210) is, e.g., additively, manufactured from a first material. The mould cavity (224) is filled with a second material after the electronic components are mounted. The filled second material is milled for obtaining an outer geometry of the dental device (200).

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 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 method of manufacturing a customized smart dental device and a 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 for 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] These objects are solved at least in part by a 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 customized smart dental device according to claim 13, and a smart dental device according claim 25. Aspects, features and embodiments of the invention are described in the dependent claims and described in the following description.

[0012] In the following, the solution according to the invention is described with respect to various aspects, such as, for example, a digital data set, a skirt portion as well a method for manufacturing a smart dental device. Features, advantages or alternative embodiments disclosed in respect of one of these aspects can, however, also be used with any other aspect of the invention.

[0013] In other words, for example, the smart dental device aspect can be improved with features described or claimed in conjunction with the method aspect, and vice versa. In this case, the functional features of the method are embodied by structural elements of the smart dental device, or vice versa. 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 digital data set, 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 digital data set for use in manufacturing of a skirt portion of a customized smart dental device is provided. The manufacturing may comprise additive manufacturing processes, thermoforming or moulding processes, and / or grinding / milling processes. The skirt portion fits tightly (and / or is customized to tightly fit) at least a facial, lingual and / or occlusal dental surface topology of a person.

[0015] The digital data set comprises an inner surface contour of the skirt portion matching (and / or customized to match) the facial, lingual and / or occlusal dental surface topology. The inner surface contour defines an occlusal surface, a facial surface and a lingual surface. The inner surface contour forms an inner surface of the skirt portion.

[0016] The digital data set further comprises an outer surface contour of the skirt portion. The outer contour defines one or more mounting surface portions for mounting at least one electronic component. Alternatively, or in addition, the outer contour at least partially forms an outer contour of the skirt portion.

[0017] The digital data set further comprises an outer mould contour defining a mould cavity. The outer mould contour defines (and / or comprises) a first contour extending essentially horizontally from a lingual surface portion of the outer surface contour. Optionally, the first contour is arranged at a lingual-side dental neck area and / or distanced from a gum area of the person’s dental surface topology.

[0018] The outer mould contour further defines (and / or comprises) a second contour extending essentially horizontally from a facial surface portion of the outer surface contour. Optionally, the second contour is arranged at a facial-side dental neck area and / or distanced from a gum area of the person’s dental surface topology.

[0019] The outer mould contour further defines (and / or comprises) a third contour and a fourth contour extending from the first contour and from the second contour, respectively, in the direction of an elevation of the outer surface contour. An elevation of the third contour and the fourth contour extends beyond the elevation of the outer surface contour. Thereby an extension, and / or a shape, of the mould cavity may be defined. The digital dataset 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.

[0020] The technique of the invention comprising the digital data set of the invention allows for manufacturing of a customized smart dental device (also: oral appliance, and / or optionally a dental treatment device, e.g., a splint, guard, retainer or brace) with very high precision and in a time-efficient manner.

[0021] Customized in the sense of the present application means that the smart dental device is fitted to the person’s anatomy, in particular the person’s dentition and / or dental surface topology (e.g., to his / her maxilla, mandible and their occlusal or masticatory surfaces.

[0022] The customized smart dental device of the invention may, e.g., be a bruxism splint (and / or smart bite-splint), or a smart retainer, equipped with components, such as, for example, sensory components, such as bite force measurement sensors, providing improved monitoring and potentially enabling the increase of application compliance of such orthodontic treatment devices. A customized smart dental device used as sleep appliance may include sensory and active components that are usable for compliance monitoring and respiration modulation. For example, for bruxism treatment, a person may benefit from a high-quality (in particular, a customized) Michigan-type bite-splints with bruxism monitoring and optional biofeedback to actively reduce the bruxism activity.

[0023] Alternatively, or in addition, the smart dental device of the invention may comprise components configured to conduct or support a medical status monitoring of the patient, such as, for example, components for recording an electrocardiograph (ECG) and / or an electroencephalograph (EEG) and / or components, in particular, sensors for recording tremor or cramping (allowing, for example, detection of seizures), sensors for conducting analyses of the person’s salvia or breath, e.g., for the presence of certain substances, etc.

[0024] Alternatively, or in addition, the smart dental device of the invention may also comprise sound or voice recording components, as well as components outputting sound audible to the wearer of the device, and / or telecommunications components for transmitting and receiving data. The customized smart dental device (also: customized smart oral appliance) being “smart” shall, in the context of the present disclosure, mean that it may comprise one or more electronic components configured for, for example, sensing a person’s dental movement and / or for providing feedback to the person upon a certain dental movement. Accordingly, a customized smart dental device for bruxism treatment according to the invention may comprise sensory components, electronic circuitry, and an energy storage unit (e.g., a battery). Thereby, for example, teeth grinding, and / or teeth clenching can be monitored, and counter measures can be taken, or the action at least induced (e.g., by alerting the person).

[0025] 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.

[0026] 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.

[0027] The digital data set may contain surface boundary information for producing the skirt portion.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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).

[0033] 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.

[0034] 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. The at least one electronic component may comprise at least two electrically, optically, and / or opto-electronically coupled components. Alternatively, or in addition, at least one electronic component may be configured for information acquisition and / or information output. The at least one electronic component may comprise an electric and / or optical circuit.

[0035] The at least one electronic component may also comprise an energy source, for example, a rechargeable battery and / or rechargeable cell (briefly: battery) or an energy harvesting component such as a biofuel cell or piezoelectric device, a microprocessor, a sensor system (comprising at least one sensor), a connection (such as, for example, one or more electrical connections) between at least some of these components, and at least one information exchange line between at least some of these components.

[0036] The first contour and the second contour of the outer mould contour may be designed and / or positioned in such a way that the smart dental device, when being worn by the person, does not contact the person’s gum and / or palate. Alternatively, or in addition, the first contour and the second contour of the outer mould contour may be designed and / or positioned such a way that the smart dental device covers at least most of the upper or lower portion of at least some of the person’s teeth, that is, the portion that is located away from the person’s gum of the lower or upper jaw of the person, respectively.

[0037] This will ensure a secure fit of the smart dental device while being worn, in particular, in the person’s molar sector, however, reduce the amount of material used for manufacture of the smart dental device. Alternatively, or in addition, to increase wearing comfort, the smart dental device may be designed in such way that the frontal sector of the smart dental device may have a smaller eight than the molar sector and, thus, cover the person’s frontal teeth to a lesser degree than is the case in the molar sector of the smart dental device.

[0038] Accordingly, the arrangement of the first contour and the second contour of the outer mould contour relative to the dental neck area and / or distance from the occlusal face of the person’s dental surface topology also represents a factor of the smart dental device of the invention subject to customization. The third and fourth contour may be designed and / or positioned in such a way that it is located in close proximity to the outer surface contour. Thereby, again, material may be saved when filling the mould cavity.

[0039] The skirt portion may be manufactured by one or multiple additive manufacturing processes, such as, for example, 3D printing using at least one 3D-printable material.

[0040] In the present specification, the mould cavity is defined as a hollow space having an opening formed in at least one side thereof. The mould cavity (also: moulding space) is configured to be filled with a (e.g., second) material in a liquid or viscous state and the material consecutively allowed to set or cure (or being cured). The filling of the mould cavity may also include an overmoulding of components or objects that have been placed inside the mould cavity prior to the filling process.

[0041] The mould cavity defined by the skirt portion as well as the first, second, third and fourth contour may be formed for least one molar section (also: the molar sector) of the outer surface contour.

[0042] The mould cavity may, in an embodiment of the invention, be provided along a surface contour, for example, the outer surface contour, covering substantially the full person’s dental surface topology, that is, comprising most of the person’s left and right molar and pre-molar sectors, the left and right canine sectors, and the incisor sector. Such an embodiment may provide a particularly stable fit of the smart dental device along the person’s dental surface topology and thus help to secure the smart dental device against coming off the teeth unintentionally while being worn, for example, during the person’s sleep.

[0043] In another embodiment, the mould cavity may be designed to cover essentially only one or both molar and / or pre-molar sectors. Such an embodiment can be particularly material-efficient and / or avoid constructional challenges that can arise due to a need for a very thin material layer of the skirt portion in the incisor sector portion. Atthe same time, such design of a molar / pre- molar splint may readily be efficient enough in protecting the person’s teeth from damage caused by bruxism or provide retention following orthodontic treatment.

[0044] In such an embodiment, separate components, such as a microprocessor, an energy source, leads, transmitters, receivers, sensor and / or active components, or the like, may be required per molar / pre-molar sector. Alternatively, or in addition, the components each of the molar / pre- molar sectors may be designed to communicate with one another using transceiver elements, such as, for example, radio, optical, and / or acoustic transceiver elements, so as to reduce the total count of components for each of the two molar / pre-molar sectors of the person for which splints are designed.

[0045] In an embodiment of the invention, the outer mould contour comprises at least one registration mark and / or registration pin. Optionally, or additionally, the at least one registration mark and / or registration pin may be arranged at a facial surface portion of the fourth contour.

[0046] The at least one registration mark (also: registration element) may comprise a protrusion and / or a recess and may be designed to form a target pattern, which, for example, may be designed to enable determining the accurate position and / or orientation of the outer mould contour in space during manufacturing, preferably after the filling of the mould cavity with a moulding material (and setting / curing thereof). Such determination of the position and / or orientation may enable an automatized downstream process, such as, a milling / grinding and / or polishing process by enabling accurate placement of the outer mould contour of a workpiece in a processing device. Alternatively, or in addition, the registration marks and / or pins may be used to enable an optical recognition of the accurate position and / or orientation of the outer mould contour in space so as to enable the downstream processing device to determine and pre-set the initial position and / or orientation before staring the processing.

[0047] Accordingly, the at least one registration mark and / or pin allow a position and / or orientation of the manufactured skirt portion, which may include the filled mould cavity (also: the workpiece) to be detected upon placing the workpiece into a processing device for removing excess material from the set or cured filling material of the mould cavity, for example, by milling or other ablation processes, with very high precision, for customizing the smart dental device to the person’s opposite occlusal surface.

[0048] Advantageously, by detecting the registration mark sand / or pins, the ablation processing device may gain exact knowledge of the position and / or orientation of the workpiece and can thus control the ablation tool with very high precision, for example, to ensure that the at least one electronic component remains fully and sufficiently covered by the set or cured filling material after the ablation. The processing using the processing device may represent or include the finishing process of the manufacturing of the workpiece, and thereby the smart dental device may be obtained.

[0049] Any surface portion may comprise at least one height / thickness indicator. Optionally, the outer surface contour of the skirt portion (and / or a surface of an electronic component extending away from the skirt portion after its mounting thereon) may comprise at least one height or thickness indicator.

[0050] The at least one height or thickness indicator may comprise at least one protrusion (e.g., of varying shape or dimension) arranged on the outer surface contour of the skirt portion. The protrusion may, for example, have a cylindrical pin or conical shape or pyramid orfrustoconical shape. The diameter of the protrusion may vary continuously or step-wise (preferably with the diameter increasing when approaching the outer surface contour).

[0051] Alternatively, or in addition, the at least one height indicator may comprise different color portions and / or different materials (e.g., a harder and / or denser material than the first material) than the material used for the manufacturing of the skirt portion.

[0052] In an embodiment, height indicators arranged on the skirt portion may be integrally manufactured with the skirt portion, for example, in the same (additive) manufacturing process.

[0053] The at least one height indicator is configured to help monitor a height (also: thickness), in particular, in the occlusally facing portion of the outer surface contour, for example, when finishing (in particular milling) the workpiece to obtain the outer surface topology of the smart dental device. This way, it may be ensured that the at least one electronic component (e.g., one or more sensors and / or actuators) remains sufficiently thickly, fully or at least sufficiently covered by the mould material.

[0054] The digital data set may further comprise at least one support structure definition enabling the additive manufacturing of the skirt portion. Optionally, the at least one support structure may be arranged along or at least contact an occlusal, facial and / or lingual surface portion of the outer surface contour of the skirt portion. The at least one support structure may facilitate the additive manufacturing process of the skirt portion, in particular, when the surface definitions include undercuts, such as, for example, due to a reduced tooth diameter in the dental neck area of the person’s dental surface topology. 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 so that it can be removed before filling the mould cavity with the filling material, such as by abrasive processes or solvents, or the likes.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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).

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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).

[0064] The third and / or fourth contour of the outer mould contour may have, or at least comprise, a standardised shape, such as, for example, a standardised inner and / or outer diameter, or other geometric shapes. Optionally, the standardized outer shape may have a polygonal or circular shape having a predetermined length, diameter and / or radius.

[0065] The standardised outer shape may be defined depending on the requirements of the manufacturing or processing devices used in the process of manufacturing the smart dental device, for example, in order to fit into a seat of the processing machine, such as an automated milling machine.

[0066] The third and fourth contours of the outer mould contour define at least in part the mould cavity, such as, for example, the outer shape and / or outer wall of the mould cavity, which is fillable with the second material. 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).

[0067] 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.

[0068] 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).

[0069] 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.

[0070] 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.

[0071] In another embodiment, the smart dental device may be arranged for use at both jaws. In this case, the outer surface of one jaw side portion of the smart dental device may match the outer surface of the other jaw side portion of the smart dental device.

[0072] 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. In a second aspect of the invention, a skirt portion customized to match a facial, lingual and / or occlusal dental surface topology of a person is provided.

[0073] The skirt portion comprises an inner surface contour customized to match the facial, lingual and / or occlusal dental surface topology. The inner surface contour defines a surface facing the occlusal dental surface (occlusal surface), a surface facing the facial dental surface (facial surface) and / or a surface facing the lingual dental surface (lingual surface). The inner surface contour forms an inner surface of the skirt portion.

[0074] The skirt portion further comprises an outer surface contour. The outer contour defines one or more mounting surface portions for mounting at least one electronic component.

[0075] The skirt portion may also, at least partially, define a mould cavity by further comprising and / or being integrally connected to an outer mould contour defining the mould cavity. The outer mould contour may comprise a first contour extending essentially horizontally from a lingual surface portion of the outer surface contour of the skirt portion. Optionally, the first contour may be arranged at a lingual-side dental neck area and / or distanced from the portion of the person’s dental surface topology contacting the gum.

[0076] The outer mould contour may further comprise a second contour extending essentially horizontally from a facial surface portion of the outer surface contour of the skirt portion. Optionally, the second contour may be arranged at a facial-side dental neck area and / or distanced from the portion of the person’s dental surface topology contacting the gum.

[0077] The outer mould contour may further comprise a third contour and a fourth contour extending from the first contour and from the second contour, respectively, in the direction of an elevation of the outer surface contour. An elevation of the third contour and the fourth contour may extend beyond the elevation of the outer surface contour of the skirt portion.

[0078] For example, by the extending beyond the elevation of the outer surface contour of the skirt portion, the third and fourth contours may define an exterior wall of a mould cavity such that, when filling the mould cavity with the mould filling material, the outer surface contour of the skirt portion may be fully covered (also: overmoulding). Accordingly, the outer mould contour, i.e. its first, second, third and / or fourth contours together with the outer surface contour of the skirt portion, at least partially define the mould cavity, which is thus fillable with the second material.

[0079] The outer mould contour may further comprise a standardized outer shape, such as, for example, a circular shape. The standardized outer shape (e.g., circular shape) may include portions of the facial surface portion outer contour, for example, in the frontal facial portion of the skirt portion.

[0080] In another aspect of the invention, a method for manufacturing a customized smart dental device according to the invention is provided. The smart dental device may be customized to tightly or snuggly fit at least a frontal and / or molar dental surface topology of the mandiubular and orthe maxillary of a person.

[0081] The method of the invention comprises a step of manufacturing a skirt portion according to the second aspect of the invention that may be based on the digital data set according to the first aspect of the invention). The skirt portion may be manufactured using a first material, for example, by additive manufacturing and / or 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.

[0082] The method further comprises a step of mounting at least one electronic component on or along the one or more mounting surface portions of the outer surface contour of the skirt portion as well as a step of filling the mould cavity with a second material.

[0083] The method further comprises a step of placing the skirt portion after filling with the filling material (also: second material) and curing or setting thereof into a subtractive processing device and detecting a position and orientation of the skirt portion having the filled moulding cavity (and including the overmoulded electronic components) inside the subtractive processing device.

[0084] The method further comprises a step of subtractively processing the second material for obtaining an outer geometry of the smart dental device which matching an occlusal surface of the person’s opposite dental surface topology and or an opposing dental device, such as, for example, a splint. The method for manufacturing the customized smart dental device according to the invention may make use of CAD / CAM (computer aided design / computer aided manufacturing). For example, the method may also make use of CAD / CAM for the mounting of the at least one electronic component, and / or for the subtractive processing. Alternatively, or in addition, the subtractive processing may make use of a digital bitefinder for matching the person’s opposite occlusal surface.

[0085] The digital data set of the invention may be generated using computer aided design (CAD) programs. Accordingly, at least parts of the design or manufacturing process of the smart dental splint of the invention and / orthe skirt portion accordingto the invention may be computer- implemented.

[0086] The method may further comprise a step ofsetting or curing the second material or allowing the filled second material to set, thereby creating an occlusal portion of the smart dental device which is, preferably, fluid-tightly embedding the at least one electronic component.

[0087] Using the method of the invention, a smart dental device may be manufactured that comprises fluid-proof sealed electronic components (e.g., comprising an energy storage unit, microprocessor, sensors, power connections, and / or actuators) and that is optimally fitted to the person’s dental status.

[0088] The skirt portion filled with the second material, in particular, before milling, may be denoted as workpiece or unfinished workpiece. The smart dental device may also be denoted as finished workpiece.

[0089] The first material may be softer and / or more elastic / bendable than the second material. The first material may, in particular, be selected for an optimal fit (and / or a comfortable fit) to the person’s teeth.

[0090] 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. 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.

[0091] The step of placing the unfinished workpiece into the subtractive processing device, and / or the step of removing material from the unfinished workpiece may be preceded by a step of clipping, for example, in cases where the filled mould cavity significantly exceeds the dimensions of the outer geometry of the smart dental device. The milling may be performed on the clipped workpiece. Clipping may also be applied to form the unfinished workpiece to have a standard shape.

[0092] The subtractive processing may at least partially be performed by means of a dental burr.

[0093] 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.

[0094] 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 standard body temperature (37°C) and medium soft at warm water temperature of 45°C to 55°C.

[0095] The first material may, for example, be a thermoflex material, a thermoplastic material, a resin, and / or a photopolymer.

[0096] The hard material may have (and / or may be defined by having) a bending strength between 10 MPa and 100 MPa. For example, a photopolymer (such as one marketed underthe name “KeySplint Hard”) may have the physical properties of an elastic modulus (also: E-modulus) between 1510 MPa and 1520 MPa (e.g., according to 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 pg / mm3(e.g., according to ISO20795-2).

[0097] The first material and / or the second material may be or may comprise a biocompatible material, such as a biocompatible resin. Biocompatible resins that may be considered as the hard material (and / or hard material part(s)) comprise an acrylic material, acrylate, methacrylate, Cyclic Olefin Polymer (COP), Cyclic Oefin Copolymer (COC), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), polycarbonate (PC), polypropylene (PP), polyethylene terephthalate (PET), polyimide, polyetherimide (PEI), nylon, and / or Ultem.

[0098] 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, for example, have an E-modulus of approximately 3100 MPa.

[0099] The soft material may 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 (such as one marketed under the 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 pg / mm3(e.g., according to ISO20795-2).

[0100] 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, for example, be indicated with a shore hardness for the soft material. At room temperature (e.g., around 20°C to 22°C), the soft material may be relatively hard but may become softer in warm water and / or when placed in the person’s oral cavity.

[0101] The second material may comprise a hard material. The hard material may, for example, be a hard-acrylic material.

[0102] 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).

[0103] 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.

[0104] 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 tick 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.

[0105] 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.

[0106] 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.

[0107] In the posterior occlusal portion, the thickness of the material layer may be preferably below 2 mm.

[0108] The skirt portion and the outer mould portion may be additively manufactured according to the digital data set of the first aspect. The method may further comprise a step of loading the digital data set into a memory of an additive manufacturing device.

[0109] 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. Optionally, the support structure may be removed by milling, grinding, cutting, or any other subtractive process.

[0110] 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.

[0111] 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).

[0112] The support structure manufactured according to the 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.

[0113] 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. Alternatively, or in addition, the at least one electronic component my operate optically and / or light-based.

[0114] 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.

[0115] The size of the PCB may comprise a length between 5 mm and 150 mm (covering the full dental arc), or 5 mm and 50 mm (covering portions ofthe dental arc) 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.

[0116] 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.

[0117] 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.

[0118] A thickness ofthe 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. 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.

[0119] 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.

[0120] 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.

[0121] 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.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] 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. 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. 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.

[0126] 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.

[0127] The method may further comprise a step of arranging at least one height indicator on the at least one electronic component. In one embodiment, the at least one height indicator may be arranged on the at least one electronic component before it is mounted on the one or more mounting surface portions of the skirt portion. In another embodiment, the at least one height indicator may be arranged on the at least one electronic component after it is mounted on the one or more mounting surface portions of the skirt portion. Alternatively, or in addition, the at least one height indicator may be arranged at the outer surface contour of the skirt portion (e.g., at the occlusal side).

[0128] In one embodiment, the at least one height indicator may be arranged on the outer surface contour of the skirt portion before the at least one electronic component is mounted. In another embodiment, the at least one height indicator may be arranged on the outer surface contour of the skirt portion after the at least one electronic component is mounted.

[0129] By arranging height indicators (e.g., on the at least one electronic component) before the mould cavity is filled, it may be ensured that the mould cavity is sufficiently filled, and that, in the step of subtractive processing and / or when manually fine-adjusting a surface ofthe smart dental device, a sufficient amount ofthe second material is applied or retained, respectively, to protect the at least one electronic component, for example, from excessive mechanical stress and / or fluid ingress.

[0130] The skirt portion manufactured from the first material and the portion moulded from the second material may be connected by a positive fit, a mechanical engagement (e.g., using a force-fit), and / or a material bond (e.g., a material fit). The skirt portion and the second material may positively fit. Alternatively, or in addition, the skirt portion and / or the second material may materially fit to the at least one electronic component (e.g., by means of an adhesive, in particular adhesive tape). In some embodiments, the first material and the second material may further be selected for chemical bonding.

[0131] 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 COP's 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).

[0132] This way, the at least one electronic component may be enclosed in an airtight and / or waterproof manner within the smart dental device.

[0133] 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 ofthe (e.g., sensitive) electronic components, or with another process that is compatible.

[0134] 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, however, not necessarily all electronic components, may be sealed against ingress of fluid such as saliva, water or air.

[0135] 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.

[0136] 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.

[0137] 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.

[0138] 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.

[0139] Brief Description of the Drawings Exemplary non-limiting embodiments are described with reference to the accompanying drawings in which:

[0140] Fig. 1 shows an exemplary flowchart of a method for manufacturing a customized smart dental device;

[0141] 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, the skirt portion being usable in the manufacturing of the customized smart dental device according to the method of Fig. 1;

[0142] Figs. 3A and 3B show exemplary elevational cross-sections of a skirt portion, e.g., the skirt portion of Fig. 2, with mounted electronic components and filled mould cavity according to an intermediary manufacturing step of the method of Fig. 1;

[0143] Figs. 4A and 4B show exemplary elevational cross-sections of a smart dental device, e.g., manufactured according to the method of Fig. 1;

[0144] Fig. 5 shows an exemplary planar cross-section of a smart dental device, e.g., the smart dental device of Figs. 4A or4B, and / or manufactured according to the method of Fig. 1;

[0145] Fig. 6 shows an exemplary perspective view of electronic components mounted on a skirt portion according to an intermediary manufacturing step of the method of Fig. 1;

[0146] Fig. 7 shows exemplary electronic components with electric connections having a meandering form;

[0147] Figs. 8 shows a further exemplary elevational view of a skirt portion with mounted electronic components as received from an intermediary manufacturing step of the method of Fig. 1;

[0148] Figs. 9A and 9B schematically illustrate a planar cross-section of a filled skirt portion before milling and after milling the filling material, respectively;

[0149] Fig. 9C schematically illustrates an elevational cross-section of a skirt portion before filling the mould cavity, the exemplary skirt portion covering both the left and right side of a person’s surface topology; Fig. 10A, 1OB and IOC 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;

[0150] Fig. 11 shows an elevational cross-sectional view of an exemplary smart dental device mounted on a person’s teeth;

[0151] Fig. 12 shows a perspective view of a person’s dental surface topology with a planned coverage by the smart dental device; and

[0152] Figs. 13 and 14 show exemplary non-smart dental devices, such as splints, manufactured with support structures known in the prior art.

[0153] Detailed Description

[0154] The present disclosure details exemplary embodiments of a technique for manufacturing a customized smart dental device.

[0155] Fig. 1 shows an exemplary flowchart of a method for manufacturing a customized smart dental device tightly fitting at least a facial, lingual and / or occlusal dental surface topology of a person. The method is generally referred to by the reference sign 100.

[0156] The method 100 comprises a step S104 of manufacturing, using a first material, a skirt portion.

[0157] The method 100 further comprises a step S106 of mounting at least one electronic component along one or more mounting surface portions of an outer surface contour of the manufactured S104 skirt portion.

[0158] The method 100 further comprises a step S108 of filling a mould cavity with a second material. The mould cavity is at least partly provided by the manufactured S104 skirt portion.

[0159] The method 100 further comprises a step S110 of placing the filled S108 manufactured S104 skirt portion into a milling device and detecting S112 a position and orientation of the filled S108 manufactured S104 skirt portion inside the mill. The method 100 further comprises a step S114 of milling the filled S108 second material for obtaining an outer geometry of the smart dental device for matching an occlusal surface of the person’s opposite dental surface topology.

[0160] Optionally, the skirt portion and the outer mould portion are additively (and / or integrally) manufactured S104, in particular according to the digital data set.

[0161] The method 100 may further comprise a step S102 of loading the digital data set into a memory of an additive manufacturing device.

[0162] The method 100 may further comprise a step S103 of providing a support structure for additively manufacturing S104 the skirt portion. The support structure for additively manufacturing S104 the skirt portion may, e.g., be meltable or dissolvable.

[0163] The method 100 may further comprise a step S105 of removing the support structure of the skirt portion, in particular additively manufactured S104 according to the digital data set. Optionally, the support structure may be removed by milling, grinding, cutting or any other subtractive process.

[0164] The method 100 may further comprise a step S109 of setting the second material or allowing the second material to set, in particular, after filling S108 the mould cavity and before placing S110 the filled S108 skirt portion into the milling device.

[0165] Fig. 2 shows an exemplary elevational cross-section of a skirt portion 210. The skirt portion may (e.g., additively) be manufactured using a first material. The skirt portion 210 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.

[0166] The skirt portion 210 further comprises a first contour 216 of an outer mould contour, a second contour 218 of the outer mould contour, a third contour 220 of the outer mould contour and a fourth contour 222 of the outer mould contour. The third contour 220 and fourth contour 222 may also be denoted as outer walls of a mould to be filled, e.g., with a second material. The first contour 216 and the third contour 220 are arranged at a lingual side (not shown in Fig. 2). The second contour 218 and the fourth contour 222 are arranged at a facial (e.g., buccal) side (not shown in Fig. 2).

[0167] At an occlusal side of the outer surface contour 214, an exemplary optional height indicator 244-1 is shown in Fig. 2. In some embodiments, the skirt portion 210 may have no height indicators. In other embodiments, the skirt portion 210 may have one or multiple height indicators (e.g., manufactured from the same first material as the skirt portion). The height indicators 244-1 may have a plurality of different shapes, e.g., conical as shown in Fig. 2, cylindrical as shown in Fig. 3B, or any other shape. The height indicators 244-1 may be integrally formed with the skirt portion 210, in particular, also using the first material. The height indicators may be used for controlling a milling after filling the mould cavity 224.

[0168] In Fig. 2, an unfilled mould cavity 224 is shown. Fig. 2 further shows exemplary registration marks 226 or registration pins 226, which may be used for correctly placing and orienting the skirt portion 210 (in particular, after filling the mould cavity 224) in a milling device.

[0169] As schematically illustrated, a thickness of the skirt portion 210 may vary from position to position. In particular, the thickness of the skirt portion at the occlusal side may vary.

[0170] Figs. 3A and 3B show an elevational cross-sectional view of exemplary skirt portions 210 (e.g., the skirt portion of Fig. 2, optionally up to differences in view of a number, placement and shape of height indicators 244-1) after filling the mould cavity using the second material. The filled mould cavity is denoted by the reference sign 228.

[0171] In Fig. 3A, exemplary electronic components (also: circuit components) are shown. An electronic component 230-1 at the facial side of the skirt portion 210 may comprise a microprocessor (e.g., realized on a printed circuit board, PCB), an energy storage unit (e.g., battery, such as a rechargeable battery, in particular a wirelessly rechargeable battery) or energy harvesting unit, such as, a thermos-electric, piezo-electric, or electrochemical energy harvester, a sensor (also: facial sensor; e.g., a temperature sensor or a movement sensor), and / or an antenna (e.g., for transmitting sensor data to an external device). An electronic component 230-3 at the occlusal side may comprise a sensor (also: occlusal sensor), such as a pressure sensor and / or a force sensor (e.g., for detecting bruxism). In Fig. 3A, at reference sign 230-2 further an electric connection is schematically shown.

[0172] The electronic components 230-1; 230-2; 230-3 in Fig. 3A are mounted at mounting surface portions 238 for the electronic components. In Fig. 3A further exemplarily at reference sign 232 an adhesive (e.g., adhesive tape) is shown, by which the electronic components 230-1; 230-3 are mounted at the mounting surface portions 238.

[0173] The distance between the third contour 220 and fourth contour 222 (and / or the distance between the third contour 220 and the lingual side of the outer surface contour 214, and / or the distance between the fourth contour 222 and the facial side of the outer surface contour 214) in Figs. 2 and 3A may define a fixed width, in particular for a minimum clearance around the walls of the tooth contact sides (and / or the inner surface contour 212 and / or outer surface contour 214).

[0174] Fig. 3B shows a variant of the skirt portion 210 with mounted electronic components 230-1; 230-3 and mould cavity filled with the second material 228. In this variant, a first type of height indicator 244-1 is arranged directly on the occlusal side of the outer surface contour of the skirt portion 210. A second type of height indicator 244-2 is arranged (e.g., fabricated) on the electronic component 230-3 mounted on its occlusal side.

[0175] Fig. 4A and 4B show elevational cross-sectional views of exemplary customized smart dental devices 200. The customized smart dental devices 200 of Figs. 4A and 4B may, e.g., be obtained by milling the filled mould cavity 228 of Figs. 3A and 3B, respectively, to arrive at the shape of the second material 228-M after milling.

[0176] At reference sign 234, 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 200 is shown after the second material 228-M has been milled. The height 234 may be adjustable 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).

[0177] At reference sign 236, an exemplary width of the second material covering the electronic component 230-1 placed at the facial side of the smart dental device 200 is shown. The first material forming the skirt portion 210 and the second material 228; 228-M may be physically and / or chemically bonded.

[0178] Fig. 4B shows a variant of the customized smart dental device 200 having height indicators 244-1 arranged on the occlusal side of the outer surface contour 214 of the skirt portion 210 as well has height indicators 244-2 fabricated and / or arranged on top of the mounted electronic component 230-3 on the occlusal side.

[0179] In any embodiment, any (e.g., the occlusal) side of the smart dental device 200 can be adjusted by a dental burr.

[0180] Manufacturing a smart dental device 200 may comprise making use of no height indicator, one or more height indicators 244-1 attached to the skirt portion 210, and / or height indicators 244-2 on any one of the mounted electronic components 230-1; 230-2; 230-3; 230-4. Any height indicator 244-1; 244-2 can serve to keep a minimum thickness of the second material 228-M over any one of the mounted electronic components 230-1; 230-2; 230-3; 230-4. This may, in particular, be relevant if a dental professional (e.g., a dentist or dental technician) manually removes part of the second material 228-M with a dental burr, e.g., to adjust the occlusion.

[0181] Fig. 5 shows a planar cross-sectional view of an exemplary customized smart dental device 200 (e.g., the same device 200 as shown in Fig. 4A or4B). Arranged on top of the skirt portion 210 are electronic components (e.g., sensors such as sensor pads) 230-3 at the occlusal side, with electronic components (e.g., a microprocessor, energy storage unit, antenna, and / or further sensors such as sensor pads) 230-1 placed at each facial buccal side, and the electronic components 230-1; 230-3 connected by electrical connections 230-2, which reach around the facial labial side to both facial buccal sides.

[0182] A variable thickness of the milled second material 228-M is exemplarily indicated at the left facial buccal side by the reference sign 236.

[0183] As schematically indicated in Fig. 5, a lingual thickness of the second material 228-M may optimally be as thin as possible, in particular, near zero at an incisal (also: labial and / or front teeth) section 258. The second material 228-M is alternatively or in addition chosen sufficiently thick to protect any one of the electronic components, e.g., the electrical connections 230-2 (e.g., along the facial labial and / or facial buccal sections) and the electronic components 230-1 arranged on the facial buccal sides of the buccal section 256. Protection comprises protecting against fluid (e.g., water and / or saliva) ingress and / or mechanical damage.

[0184] Fig. 6 shows an exemplary perspective view of a skirt portion 210 with mounted electronic components 230-1; 230-2; 230-3; 230-4. The example shown in Fig. 6 includes, in particular, further electronic components 230-4 at the lingual surface of the skirt portion 210, such as, for example, one or more additional sensors, such as, pressure sensors, force sensors, and / or sensors that may be placed so as to be in contact with the gingiva, and / or one or more other circuit components, such as energy storage units, energy harvesting units, microprocessors and / or other electronic components, as described in greater detail elsewhere in this specification.

[0185] In one embodiment, the perspective view of Fig. 6 shows a skirt portion 210 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. 6 shows only a part of the skirt portion 210 ranging only from the buccal section 256 to the incisal section 258, with another part of the skirt portion 210 extending along the opposite facial side of the person.

[0186] Any one of the electronic components (e.g., sensors and / or circuit components) 230-1; 230-2; 230-3; 230-4 may be flexible and / or rigid (e.g., independently per component).

[0187] In Fig. 6, the electronic component 230-1 is exemplarily positioned and / or fixed using an adhesive (e.g., adhesive tape) 232.

[0188] The exemplarily shown mounting surface portion 238 may comprise an indentation, a protrusion, recess, or any other position aid formed to guide the placement of the electronic component (e.g., 230-1).

[0189] Fig. 7 exemplarily shows an ensemble of electronic components 230-1; 230-2; 230-3; 230-4. In the example, facial side electronic component 230-1 (e.g., comprising the energy storage unit and microprocessor) is connected by electric connections 230-2 to electronic components 230-3 and 230-4 at the occlusal and lingual sides, respectively.

[0190] The electric connections (also: conductors) 230-2 in the example of Fig. 7 are realized in meandering form, allowing for stretching among the electronic components (also: substrates) 230-1; 230-3; 230-4. 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.

[0191] Fig. 7 exemplarily shows an ensemble of electronic components 230-1; 230-2; 230-3; 230-4 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.

[0192] Any one of the electronic components (also: substrates) 230-1; 230-3; 230-4 may be formed as a pad, such as a sensor pad.

[0193] Fig. 8 shows an alternative example of a skirt portion with mounted electronic components 230- 1; 230-2; 230-3 and filled mould 228, with a final shape of the second material 228-M after milling. Fig. 8 also shows registration marks 226 or registration pins 226 located at the third contour 220 and the fourth contour 222 of the outer mould contour in an elevational cross-section.

[0194] The skirt portion with outer mould contour (in particular, comprising first, second, third and fourth contours 216; 218; 220; 222) - collectively also denoted as “first 3D printed part” - of Fig. 8 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 standardized outer format), in particular defining a mould cavity, and some registration marks 226 or registration pins 226 may be manufactured integrally (and / or in one piece).

[0195] 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. The electronic components (e.g., comprising sensors) 230-1; 230-2; 230-3 may then be mounted (also: placed) on the first additively manufactured (and / or 3D printed) part of the smart dental device and / or fixed in place, e.g., using shape conformal adhesive tape.

[0196] Afterwards, the mould cavity may be filled, in particular, with a second material such as a hard- acrylic material.

[0197] The smart dental device (e.g., a splint) 200 may be obtained by milling down to the outer geometry defined in a design. A fixed minimum height over any electronic component (e.g., sensor) 230-1; 230-2; 230-3 can be assured, as the registration marks allow the positioning inside a milling device (briefly: mill) according to the designed assembly. Clipping of the form and / or polishing may be one mor more further manual steps.

[0198] In particular, 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.

[0199] The steps of removing the support structures and / or placing the electronic components may be performed manually and / or using a robotic device.

[0200] 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.

[0201] 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.

[0202] The design of the smart dental device may, e.g., comprise a digital data set for use in manufacturing the skirt portion.

[0203] 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 outer mould contour as well as the (e.g., final) shape of the smart dental device after milling.

[0204] 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 inside a milling device (e.g., by means of including registration marks or registration pins in the design) may be achieved by the (e.g., CAD) design.

[0205] The smart dental device may be manufactured by means of CAD / CAM. E.g., the steps of the method of Fig. 1 may be performed using CAM.

[0206] The electronic components may, e.g., be mounted using an (e.g., frictional) adhesion (and / or non-positive fit). When filling in the mould material, 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.

[0207] The milling by a milling device may be followed up by a fine-tuning of the smart dental device surface (e.g., manually and / using a dental burr).

[0208] Fig. 9A shows an exemplary workpiece (also: “blank”) for milling (e.g., in a schematic planar cross-sectional view). The “blank” comprises the skirt portion 210 with mounted electronic components. With the skirt portion 210, the outer mould contour with standardized (e.g., circular) outer shape 252 is formed. In the example of Fig. 9A, the standardized (e.g., circular) outer shape 252 of the outer mould contour comprises a plurality of registration marks 226 (e.g., indicated by a circular shape) and / or registration pins 226 (e.g., indicated by a triangular shape).

[0209] In the example of Fig. 9A, nearly all of the space within the standardized (e.g., circular) outer shape 252 may form the mould cavity filled with the second material 228.

[0210] Fig. 9B shows the exemplary workpiece (also: “blank”; e.g., in the same schematic planar cross- sectional view) after milling, such that milled second material 228-M remains connected to the skirt portion 210 and an empty space 254 arises around the milled second material 228-M.

[0211] Fig. 9C shows an exemplary elevationa I cross-sectional view of a further skirt portion with integrally formed outer mould contour before filling the mould cavity 224. In this example, a hollow space 250 bounded by the outer mould contour is arranged to be not filled. Thereby, an amount of second material may be saved, even though the outer mould contour comprises a standardized (e.g., circular) outer shape and / or dimension.

[0212] Fig. 10A provides a simplified perspective view of a skirt portion 210, with Figs. 10B and 10C showing different types of support structures for additive manufacturing of the skirt portion 210 in an elevational cross-sectional view.

[0213] In Fig. 10B, a (e.g., meltable and / or dissolvable) support structure 240 is provided at the inside of the inner surface contour 212 of the skirt portion 210. 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 210 using the first material.

[0214] 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 210. The support structure 240 may be sacrificed, e.g., by melting and / or dissolving, after the skirt portion 210 has been printed. The wall thickness of the skirt portion 210 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 210).

[0215] The printing (and / or additive manufacturing) direction of a multi-material printing (and / or additive manufacturing) in Fig. 10B may be from bottom to top.

[0216] In Fig. 10C, a support structure 242 is provided at the outer surface contour 214 of the skirt portion 210. The support structure 242 may be additively manufactured along with the skirt portion 210, e.g., also using the first material.

[0217] The printing (and / or additive manufacturing) direction according to Fig. 10C may be from top to bottom.

[0218] In particular, in sections of the skirt portion 210, 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.

[0219] Fig. 11 shows a further exemplary elevational cross-sectional view of a smart dental device 200 arranged over a person’s dental topology (briefly also: tooth). The smart dental device 200 in Fig. 11 comprises an electronic unit 230-1 as electronic component at the facial side. The electronic unit 230-1 comprises an energy storage unit 230-1A (and / or an energy magnet and / or an optical energy storage), a microprocessor 230-1B and an antenna 230-1C (e.g., a communication IC, integrated chip, antenna).

[0220] 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 200 (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 200. The smart dental device (e.g., splint) 200 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.

[0221] 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) 200 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) 200 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.

[0222] The smart dental device (e.g., splint) 200 may be configured for good retention, e.g., due to the possibility of having small undercuts 260 as exemplified in Fig. 11.

[0223] 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.

[0224] Optionally, the smart dental device (in particular, its energy storage unit) may be charged wirelessly.

[0225] 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.

[0226] 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.

[0227] 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. 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.

[0228] Fig. 12 shows an exemplary undercut line (and / or undercut area) 262, 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 262. By the undercut line 262 and / or the lower boundary of the smart dental device, an (e.g., minimal or maximal) extension of a vertical space 264 for placing electronic components 230-1; 230-4 is defined.

[0229] Fig. 13 shows an example of a non-smart splint additively manufactured using support structures 242’ on the outer surface according to the prior art.

[0230] Fig. 14 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.

[0231] In both prior art examples of Figs. 13 and 14, no electronic components and no manufacturing using two (in particular, a first and second) material are foreseen.

[0232] 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.

[0233] 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).

[0234] Advantageously, the first material and the second material may be selected to be two perfectly bondable materials. 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.

[0235] The manufacturing method may comprise that the filling mould is part of a single print that forms also the dental surface topology (also: tooth) contact side of the smart dental device (e.g., splint).

[0236] 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 smart dental device.

[0237] A mould (e.g., comprising the skirt portion and an outer mould contour) may be, in particular, additively manufactured, such as, 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).

[0238] 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 a mould cavity (also: fillable cavity).

[0239] 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.

[0240] 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).

[0241] 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).

[0242] The mould cavity (also: fillable cavity of the mould) may be filled with a second (e.g., hard and thus millable) material. Once hardened, the second (e.g., hardened millable) material may be 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.

[0243] 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.

[0244] List of Reference Signs

[0245] 100 Manufacturing method

[0246] 5102 Step of loading a digital data set

[0247] 5103 Step of providing a (in particular meltable) support structure

[0248] 5104 Step of additively manufacturing a skirt portion using a 1stmaterial

[0249] 5105 Step of removing an additively manufactured support structure

[0250] 5106 Step of mounting an electronic component

[0251] 5108 Step of filling a mould cavity

[0252] 5109 Step of setting the 2ndmaterial or allowing the 2ndmaterial to set

[0253] 5110 Step of placing a workpiece into a mill

[0254] S112 Step of detecting a position and orientation of the workpiece inside the mill

[0255] S114 Step of milling the workpiece for obtaining a smart dental device

[0256] 200 Smart dental device

[0257] 210 Skirt portion (in particular additively manufactured from 1stmaterial)

[0258] 212 Inner surface contour

[0259] 214 Outer surface contour

[0260] 216 1stcontour of the outer mould contour 2ndcontour of the outer mould contour

[0261] 3rdcontour of the outer mould contour

[0262] 4thcontour of the outer mould contour

[0263] Mould cavity

[0264] Registration mark or registration pin

[0265] Filled mould cavity (in particular using 2ndmaterial) -M 2ndmaterial after milling -1 Electronic component(s) at facial surface (e.g., microprocessor, energy storage unit, sensor, and / or antenna) -2 Electronic component, in particular electrical connection -3 Electronic component at occlusal surface (e.g., sensor, in particular pressure sensor and / or force sensor) -4 Electronic component at lingual surface (e.g., sensor, in particular pressure sensor and / or force sensor)

[0266] Adhesive (e.g., adhesive tape)

[0267] Height of the 2ndmaterial at the occlusal surface after milling

[0268] Width of the 2ndmaterial atthe facial surface after milling

[0269] Mounting surface portion for one or more electronic components

[0270] Meltable and / or dissolvable support structure ; Additively manufactured support structure ’ -1 Height indicator at occlusal surface of skirt portion -2 Height indicator placed in electronic component at occlusal surface

[0271] Hollow space bounded by outer mould contour (e.g., not to be filled)

[0272] Standardized outer shape of outer mould contour

[0273] Empty space after milling

[0274] Buccal section of the smart dental device and / or skirt portion

[0275] Labial / incisal section of the smart dental device and / or skirt portion

[0276] Undercut area with opening angle

[0277] Undercut line along the person’s dental surface topology

[0278] Available vertical space for electronic components

Claims

Patent Claims1. A digital data set for use in manufacturing of a skirt portion (210) of a customized smart dental device (200), the skirt portion (210) tightly fitting at least a facial, lingual and / or occlusal dental surface topology of a person, wherein the digital data set comprises: an inner surface contour (212) of the skirt portion (210) customized to match the facial, lingual and / or occlusal dental surface topology, the inner surface contour (212) defining an occlusal surface, a facial surface and a lingual surface, wherein the inner surface contour (212) forms an innersurface of the skirt portion (210); an outer surface contour (214) of the skirt portion (210), wherein the outer contour defines one or more mounting surface portions (238) for mounting at least one electronic component; and an outer mould contour defining a mould cavity (224), defining:• a first contour (216) extending essentially horizontally from a lingual surface portion of the outer surface contour (214), in particular wherein the first contour (216) is arranged at a lingual-side dental neck area and / or distanced from a gum area of the person’s dental surface topology;• a second contour (218) extending essentially horizontally from a facial surface portion of the outer surface contour (214), in particular wherein the second contour (218) is arranged at a facial-side dental neck area and / or distanced from a gum area of the person’s dental surface topology; and• a third contour (220) and a fourth contour (222) extending from the first contour (216) and from the second contour (218), respectively, in the direction of an elevation of the outer surface contour (214), wherein an elevation of the third contour (220) and the fourth contour (222) extends beyond the elevation of the outer surface contour (214).

2. Digital data set according to claim 1, wherein the mould cavity (224) is provided at least along a molarsector of the outer surface contour (214), and optionally, along both molar sectors of the outer surface contour (214).

3. Digital data set according to claim 1 or 2, wherein the outer mould contour further comprises at least one registration mark (226) and / or registration pin (226), and optionally, wherein the at least one registration mark (226) and / or registration pin (226) is arranged on a facial surface portion of the fourth contour (222).

4. Digital data set according to any one of claims 1 to 3, wherein a surface portion comprises at least one height indicator (244-1), and optionally, the outer surface contour (214) of the skirt portion (210) comprises at least one height indicator (244-1).

5. Digital data set according to any one of claims 1 to 4, further comprising at least one support structure (240; 242) for manufacturing the skirt portion (210), in particular, wherein the at least one support structure (240; 242) is arranged along an occlusal, facial and / or lingual surface portion of the outer surface contour (214) of the skirt portion (210).

6. Digital data set according to any one of claims 1 to 5, wherein the one or more mounting surface portions (238) comprise one or more indentations and / or one or more cavities, and / or wherein the one or more mounting surface portions (238) are provided on the facial surface and / or in a molar sector.

7. Digital data set according to any one of claims 1 to 6, wherein the one or more mounting surface portions (238) comprise a meandering form for mounting at least one electric connection, in particular, wherein the meandering form is customized to the person’s dental surface topology.

8. Digital data set according to any one of claims 1 to 7, wherein the outer mould contour comprises a standardized outer shape (252) extending outwardly from the third contour (220) and the fourth contour (222), in particular, wherein the standardized outer shape (252) is a circular shape, preferably, having a predetermined radius.

9. Digital data set according to any one of claims 1 to 8, wherein the outer surface contour (214) of the skirt portion (210) comprises a predefined surface roughness and / or predefined surface features, such as protrusions and / or recesses, for physically engaging with a mould cavity (224) filling material.

10. 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 (210) customized to match a facial, lingual and / or occlusal dental surface topology of a person, wherein the skirt portion (210) comprises:• an inner surface contour (212) customized to match the facial, lingual and / or occlusal dental surface topology, the inner surface contour (212) defining an occlusal surface, a facial surface and a lingual surface, wherein the inner surface contour (212) forms an inner surface of the skirt portion (210); and an outer surface contour (214), wherein the outer contour defines one or more mounting surface portions (238) for mounting at least one electronic component.

12. Skirt portion (210) according to claim 11, further comprising an outer mould contour defining a mould cavity (224), the outer mould contour comprising:• a first contour (216) extending essentially horizontally from a lingual surface portion of the outer surface contour (214) of the skirt portion (210), in particular wherein the first contour (216) is arranged at a lingual-side dental neck area and / or distanced from a gum area of the person’s dental surface topology;• a second contour (218) extending essentially horizontally from a facial surface portion of the outer surface contour (214) of the skirt portion (210), in particular, wherein the second contour (218) is arranged at a facial-side dental neck area and / or distanced from a gum area of the person’s dental surface topology; and• a third contour (220) and a fourth contour (222) extending from the first contour (216) and from the second contour (218), respectively, in the direction of an elevation of the outer surface contour (214), wherein an elevation of the third contour (220) and the fourth contour (222) extends beyond the elevation of the outer surface contour (214).

13. A method (100) for manufacturing a customized smart dental device (200) tightly fitting at least a facial, lingual and / or occlusal dental surface topology of a person, comprising the steps of:• manufacturing (S104), using a first material, a skirt portion (210) according to claim 11 or 12;• mounting (S106) at least one electronic component along the one or more mounting surface portions (238) of the outersurface contour (214) of the manufactured (S104) skirt portion (210); filling (S108) a mould cavity (224) with a second material, wherein the mould cavity (224) is at least partly provided by the manufactured (S104) skirt portion (210);• placing (S110) the filled (S108) manufactured (S1O4) skirt portion (210) into an subtractive processing device and detecting (S112) a position and orientation of the filled (S108) manufactured (S104) skirt portion (210) inside the milling device; and• subtractively processing (S114) the filled (S108) second material for obtaining an outer geometry of the smart dental device (200) for matching an occlusal surface of the person’s opposite dental surface topology.

14. Method (100) according to claim 13, 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 degree C and medium soft at warm water temperature of 45 degree C to 55 degree C.

15. Method (100) according to claim 13 or 14, wherein the second material comprises a hard material.

16. Method (100) according to any one of claims 13 to 15, wherein the skirt portion (210) and the outer mould portion are additively manufactured (S104) according to the digital data set of any one of claims 1 to 10, and wherein the method (100) comprises the step of:• loading (S102) the digital data set into a memory of an additive manufacturing device.

17. Method (100) according to claim 16, further comprising at least one of the steps of: providing (S103) a support structure (240; 242) for additively manufacturing (S104) the skirt portion (210), and optionally, a meltable or dissolvable support structure (240) for additively manufacturing (S104) the skirt portion (210); andremoving (S105) the support structure (240; 242) of the skirt portion (210) additively manufactured (S104) according to the digital data set, and optionally, removing the support structure (240; 242) by milling, grinding, cutting or other subtractive processes.

18. Method (100) according to any one of claims 13 to 18, wherein the at least one electronic component comprises an, in particular electrical, energy storage unit, a microprocessor, at least one sensor and, in particular electrical, connections for providing, in particular electrical, energy from the, in particular electrical, energy storage unit to at least the microprocessor and the at least one sensor, and optionally, wherein the energy storage unit is wirelessly rechargeable.

19. Method (100) according to any one of claims 13 to 18, wherein the at least one electronic component comprises a communication unit, preferably wherein the communication unit comprises an antenna for wirelessly transmitting data, the data preferably having been acquired by means of the at least one sensor.

20. Method (100) according to any one of claims 13 to 19, wherein the at least one electronic component comprises at least one feedback component, in particular, the at least one feedback component 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.

21. Method (100) according to any one of claims 13 to 20, wherein the at least one electronic component is mounted (S106) using an adhesive (232), in particular, an adhesive tape (232).

22. Method (100) according to any one of claims 13 to 21, further comprising a step of arranging at least one height indicator (244-1; 244-2) on the at least one electronic component and / or on the outer surface contour of the skirt portion, wherein optionally the at least one heightindicator (244-1) arranged on the outer surface contour ofthe skirt portion is arranged at an occlusal side.

23. Method (100) according to any one of claims 13 to 22, wherein the skirt portion (210) manufactured (S104) from the first material and the portion (S112) moulded from the second material are connected by at least one of a positive fit, a mechanical engagement, preferably using a force-fit, or a material bond, preferably using a material fit.

24. Method (100) according to any one of claims 13 to 23, wherein the skirt portion (210) (S104) manufactured from the first material and the portion (S112) moulded from the second material are connected in a sealed configuration, and in particular, are connected in a fluid- and / or airtight configuration, to seal the at least one electronic component against ingress of fluid or air.

25. A smart dental device (200) comprising:• a skirt portion (210) comprising a first material according to claim 11 or 12;• at least one electronic component mounted on the one or more mounting surface portions (238) ofthe skirt portion (210); and• an outer geometry portion comprising a second material for substantially matching an occlusal surface of the person’s opposite occlusal dental surface topology, wherein the first material and the second material are connected in a fluid- and / or airtight configuration, to seal the at least one electronic component against ingress of fluid or air.

26. Smart dental device (200) according to claim 25, the device being manufactured using the method (100) of claims 13 to 24.

7. Smart dental device (200) according to claim 25 or 26, wherein the device (200) is a smart dental treatment device, in particular, selected from a group comprising:• an occlusal splint, in particular, a Michigan splint, or another flat-plane bite splint;• a guard, in particular, an aligner-like guard, a sport guard, and / or a night guard;• a retainer;• a dental brace; and• an anti-snoring device and / or a mandibular advancement device.

28. A transient or non-transient storage medium having information embodied thereon, which, when loaded into a memory of a computer, represent a digital data set of any of claims 1 to 10.

29. 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, wherein the information may be embodied in a packeted form or in a stream.

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