DE102024116966A1 - Technology for manufacturing a customized intelligent dental device and customized intelligent dental device - Google Patents

Abstract

The invention relates to the manufacture of a customized intelligent dental device (600). A digital apron section data set can be used in the manufacture. The apron section (200) closely conforms to the facial, lingual, and/or occlusal tooth surface topology of a person. The apron section digital data set defines an inner surface contour. The apron section digital data set also defines an outer surface contour of the apron section, which has one or more attachment surface sections (216) for attaching electronic components (630-1; 630-2; 630-3). The outer surface contour of the apron section (400) defines an apron-side sealing structure (218) that is designed to engage sealingly with a mold-side sealing structure of a mold section (400). The apron-side sealing structure defines a boundary line of a formed mold cavity.

Description

Field of invention

The present invention relates to a technique for manufacturing a customized intelligent dental device and to a customized intelligent dental device (e.g., a dental treatment device such as a splint). In particular, the invention provides: a skirt section digital data set for use in the manufacture of a skirt section of a customized intelligent dental device, a skirt section of the customized intelligent dental device, a mold section digital data set for use in the manufacture of a mold section for the manufacture of a customized intelligent dental device, a mold section for use in the manufacture of a mold section for the manufacture of a customized intelligent dental device, a method for manufacturing the customized intelligent dental device, and the customized intelligent dental device itself.

Background of the invention

Bruxism is a common phenomenon, affecting approximately 8 to 12% of the population with repetitive jaw muscle activity such as teeth clenching, grinding, or clenching during sleep, and even more than 20% while awake.

Oral appliances, such as dental splints for the treatment of bruxism, are well-established in dental technology. For example, a Michigan splint is an example of an oral appliance that covers the occlusal surface of all teeth in either the upper or lower jaw and is therefore referred to as a "full-arch splint." Appliances of this type are generally custom-made for the patient's tooth surfaces and are thus characterized by a unique and highly detailed topology. They are typically made of a hard plastic such as polymethyl methacrylate or similar materials.

Unfortunately, patient compliance with aids such as retainers, dental splints, or night guards is sometimes incomplete, and it is believed that better monitoring, combined with active engagement with the patient, could improve compliance with retainers, bite splints, or sleep aids. Furthermore, it would be desirable to obtain additional information, such as better insight into the patient's usage patterns, treatment progress, or other physiological data during the use of such aids.

Attempts have already been made to design individually adapted as well as standardized monitoring devices for use by patients; however, these existing devices were often bulky and therefore not comfortable enough to achieve sufficient compliance. Furthermore, many known devices have proven to be insufficiently durable or complex to manufacture.

There is therefore a need for improved dental appliances, such as intelligent dental appliances that are individually adapted to the topology of a person's tooth surface and that can overcome at least some of the disadvantages of known dental appliances. In particular, there is a need for improved dental appliances that enable enhanced monitoring and/or treatment. Specifically, there is a need for improved dental appliances that are individually adapted to their user and thus offer improved wearing comfort, in order to improve patient monitoring and compliance, among other things. Furthermore, there is a need for improved manufacturing techniques that enable the production of dental appliances with improved durability and wear resistance.

Brief description

This problem is at least partially solved by an apron section digital data set for use in the manufacture of an apron section of a customized intelligent dental device according to claim 1, an apron section according to claim 11, a method for manufacturing an apron section according to claim 12, a mold section digital data set for use in the manufacture of a mold section for the manufacture of a customized intelligent dental device according to claim 17, a mold section according to claim 21, a method for manufacturing a mold section for the manufacture of a customized intelligent dental device according to claim 22, A method for manufacturing a customized intelligent dental device according to claim 26 and an intelligent dental device according to claim 33. Aspects, features and embodiments are described together with advantages in the dependent claims and in the following description.

The following describes the solution according to the invention with respect to the claimed apron section digital data set, the claimed mold section digital data set, the apron section, the mold section, the individually adapted intelligent dental device, the method for manufacturing the apron section, the method for manufacturing the mold section, and the method for manufacturing an intelligent dental device. Features, advantages, or alternative embodiments herein may be assigned to the other claimed items (e.g., the apron section, the mold section, and/or the intelligent dental device) and vice versa.

In other words, the apron section, the mold section, and/or the smart dental device can be enhanced with features described or claimed in connection with the corresponding manufacturing process, and vice versa. In this case, the functional features of the process are embodied by structural elements of the apron section, the mold section, and/or the smart dental device, and vice versa. Likewise, features described in connection with the device or its carrier, such as anatomical orientations or process steps, are to be understood as also referring to the corresponding definitions of the surface sections of the corresponding digital datasets, and vice versa. In particular, for example, a reference to the digital definition of a surface should also serve as a reference to the physical surface once the device has been manufactured according to the digital definition, and vice versa.

In a first aspect of the invention, an apron section digital dataset is provided for use in the fabrication of an apron section of a custom-made smart dental device. The apron section fits snugly (or closely) to at least one facial, lingual, and/or occlusal tooth surface topology of an individual. The apron section digital dataset defines an inner surface contour of the apron section that is adapted to match the facial, lingual, and/or occlusal tooth surface topology; that is, the inner surface contour defines a surface facing an occlusal surface, a surface facing a facial surface, and a surface facing a lingual surface of the individual's tooth topology. The inner surface contour is designed to form an inner surface of the apron section.

The apron section digital data set also defines an outer surface contour of the apron section. The outer contour has one or more mounting surface sections for attaching at least one electronic component. The outer surface contour of the apron section defines at least one apron-side sealing structure designed for a sealing engagement with a mold-side sealing structure of a mold section. The apron-side sealing structure defines a boundary line of a mold cavity, which is defined by at least a portion of the outer surface contour of the apron section as a section of the inner mold cavity contour.

With the technique according to the invention, which comprises the apron section digital data set of the first aspect, a digital data set for the mold area, an individually adapted apron section and an individually adapted mold area, an individually adapted intelligent dental device (also: oral device and/or optionally a dental treatment device, such as a splint, a protective splint, a retainer or a brace) can be manufactured with very high precision and in a time-saving manner.

The apron section digital data set can be embodied on a volatile or non-volatile storage medium or on a carrier wave in packetized form, such as in TCP/IP packets, or as a stream, such as a UDP stream.

In the context of this disclosure, “customized” means that the intelligent dental device is manufactured to fit the specific anatomy of the person with high precision, in particular the person’s dentition and/or tooth surface topology, such as their maxilla, mandible and/or their occlusal surfaces (also: masticatory surfaces or chewing surfaces).

The adapted smart dental device can be, for example, a bruxism splint (and/or a smart bite splint) or a smart retainer, for instance to increase compliance in orthodontic treatments and/or to enhance treatment with sensory components, such as... Tooth force measurements can be improved. A custom-fitted smart dental device used as a sleep aid may have sensor components that can be used to monitor compliance, respiration, and/or collect other health information. For example, individuals undergoing bruxism treatment may benefit from a high-quality (especially custom-fitted) Michigan bite guard with bruxism monitoring and optional biofeedback to actively reduce bruxism activity.

The inventive method enables the production of an intelligent dental appliance that avoids significant subtractive material removal. Because the mold cavity is formed by the mold section and the apron section when these are joined, an outer occlusal surface of the intelligent dental appliance, which corresponds to the opposing occlusal tooth surface topology of the individual, can be obtained (essentially directly) from the molding/filling process. Alternatively or additionally, only minor adjustments may be necessary, for example by a dentist or dental technician, when the adaptation of the individually fitted intelligent dental appliance to the individual is completed.

This ensures that the at least one electronic component attached to the mounting surface remains completely covered by the second material when the intelligent dental device is completed.

The "intelligent" nature of a custom-made intelligent dental appliance can be demonstrated by the fact that one or more electronic components are designed, for example, to detect a person's bite movements and/or provide feedback on these movements. For instance, the custom-made intelligent dental appliance might include overmolded sensor components and an electronic circuit with an energy storage unit (e.g., a battery) for use in bruxism treatment. This allows for the monitoring of bruxism, teeth grinding, and/or teeth clenching, and the implementation or at least initiation of countermeasures (e.g., by alerting the individual).

The digital data set according to the invention can be acquired using a computer-aided design (CAD) system, digital scanning devices, automatic topology matching algorithms, etc. The topology of a person's tooth surface can be acquired, for example, using an intraoral scan (e.g., a radiological scan, a laser scan, an ultrasound scan, a computed tomography (CT) scan, and/or a magnetic resonance imaging (MRI) scan), a dental impression (e.g., a plastic or plaster impression), a three-dimensional (3D) digital patient model, or similar methods. Necessary modifications can then be performed in silico, and the resulting digital data set according to the invention can be stored in a storage device or output to a manufacturing device.

The technology according to the invention can utilize integrated computer-aided design (CAD) and computer-aided manufacturing (CAM), or CAD/CAM for short. The use of CAD/CAM enables or improves the placement of electronic components such as sensors, processing units, transmitters, receivers, digital components, circuits, etc., along the occlusal, lingual, or facial surfaces of the smart dental device. Alternatively or additionally, CAD/CAM enables or improves the combination of various manufacturing processes, such as additive manufacturing (e.g., 3D printing), casting, milling, etc. The technology according to the invention thus enables or improves the time- and cost-efficient and/or automated production of a customized smart dental device, such as a Michigan splint, a retention device, or similar device containing electronic components.

The apron section digital data set can contain surface boundary information (e.g., regarding the inner surface contour of the apron section) for the manufacture of the apron section.

Each contour of the digital dataset can contain a definition of a shape and a dimension. The dimensions can differ between different groups of people; for example, the tooth surface topology of an adult may be larger than that of a child. The tooth surface topology of a person can also generally be arc-shaped in plan view, with the width of the arc often being person-specific. Furthermore, the (relative) sizes of the teeth (and/or gaps resulting from missing teeth, e.g., after their extraction) would also contribute to a person-specific shape and/or dimension.

In the context of this description, the intelligent dental device means that it (and thus the data set used to manufacture it) is designed with a shape and dimensions suitable for use on and/or fitting at least one part of the person's dentition. The intelligent dental device (and/or its apron section) may be designed so as not to obstruct the person's palate.

In the context of this description, the intelligent nature of the dental appliance can also mean that the apron section fits closely or snugly to at least part of the person's facial tooth surface topology, at least part of the person's lingual tooth surface topology, and/or at least part of the person's occlusal tooth surface topology. Here, "fit" can refer to a close match between a positive shape (also: a positive representation of a structure) and a negative shape (also: a negative representation of a structure), and vice versa.

The facial surface (and/or facial surface topology) can have any surface (and/or contour) facing the outside of the person's oral cavity (face). The facial surface can have buccal and labial surface sections, depending on the position of the respective surface along the dental arch.

The lingual surface (and/or lingual surface topology) can have any surface (and/or contour) that is aligned with an inner part of the person's dental arch (and/or the palate or the position of the tongue).

The occlusal surface (also masticatory surface and/or chewing surface) and/or the occlusal surface topology can have any surface (and/or contour) that is generally oriented towards the opposing dentition and against which the teeth come into contact when biting or grinding.

Thus, the topology of the facial, lingual and/or occlusal tooth surfaces of the person can be considered defining a positive contour, while the apron section would at least represent a matching or corresponding or appropriate negative contour, or vice versa.

The outer surface contour can cover the inner surface contour and/or be arranged in a generally parallel arrangement to it.

The definition of one or more attachment surface sections can define one or more protrusions, one or more depressions and/or one or more cavities on the second surface section.

The one or more attachment surface sections can be provided on the facial surface, the occlusal surface and/or the lingual surface of the second surface section. In particular, the attachment surface sections can tend to be arranged in the molar region, at least in the direction of the molar region of the surface definition of the digital data sets according to the invention.

Alternatively or additionally, one or more mounting surface sections can have one or more recesses and/or pockets (also: pouches and/or gaps). After the skirt section has been overmolded with the molding material, pockets, pouches, and/or gaps can help to better protect the at least one attached electronic component from the ingress of fluids and/or from mechanical stress.

Mounting surface sections featuring protrusions, recesses, and/or cavities can enable or at least facilitate more precise positioning and/or fixing of the electronic component with high precision. Alternatively or additionally, the electronic component can be attached to one or more mounting surfaces with an adhesive, for example, double-sided adhesive tape applied to the mounting surface section before the electronic component is placed.

Alternatively or additionally, one or more mounting surface sections can have one or more spacers. The one or more spacers can, for example, ensure that after the mounting of the at least one electronic component, a hollow space remains that at least partially surrounds the at least one electronic component and is filled with a molded cavity. The space can be filled with filler material or can even be designed so that it remains unfilled (e.g. to create a gas-filled gap in the material).

The at least one electronic component is preferably attached to the facial side of the outer surface contour and/or in the molar area of the individually adapted intelligent dental device, since there is preferably a certain anatomical gap in this area which helps to avoid space and/or thickness limitations in the intelligent dental device.

At least part of the one or more attachment surfaces can have a meandering section for attaching at least one electrical or optical conductor. The meandering shape can be individually adapted to the person's tooth surface topology and can be designed to achieve, for example, a specific overall length, capacitance, or inductance.

The at least one electronic component can have at least one electrical or optical connection (also: conductor). By using a meandering conductor path, a standardized length of the at least one electrical or optical connection can be achieved despite variations in patient anatomy. The at least one connection can thus be individually adapted to the dimensions and shape of the dental arch and the tooth surface topology of the person by adjusting the meandering shape accordingly.

Thus, the intelligent dental device can contain several electronic components, which may be pre-assembled and/or a standardized electronic unit, e.g., an energy storage unit, a microprocessor, a sensor system, an actuator, a transmission component, and at least one electrical connection that connects these components to each other and/or to the energy storage unit (also: power source).

The energy storage unit can, for example, be attached to the facial surface of the apron section, since the thickness of the intelligent dental device is subject to stricter limitations on the lingual and/or occlusal sides than on the facial side. Alternatively or additionally, at least one sensor can be attached to the occlusal surface of the outer contour of the apron section to detect force and/or pressure, such as when clenching the teeth.

The apron section can be arranged or positioned so that the smart dental appliance does not come into contact with the person's gums when worn. Alternatively or additionally, the apron section can be arranged or positioned so that the smart dental appliance only partially covers the person's teeth when worn. To ensure a good fit, the smart dental appliance can, for example, almost completely cover the teeth in a molar region, particularly in both molar regions of the mandible and/or maxilla, to guarantee a secure fit. Alternatively, the smart dental appliance can only partially cover the person's front teeth to achieve a comfortable fit.

The arrangement in relation to the neck area of the tooth and/or the distance to the gum area of the person's tooth surface topology can define a tooth covering of the intelligent dental device in the sense of an individually adapted tooth model.

The sealing engagement of the sealing structures of the skirt section and the mold section can provide a sealed configuration for filling the mold cavity. For example, the sealed configuration can be fluid-tight, at least for a viscous (second) material to be filled into the mold cavity. A sealing engagement can be achieved by a sealing geometry in which the skirt section and the mold section engage fluid-tight, such as a labyrinth seal or a compression seal, wherein one side is formed with a tapered edge, preferably made of a hard material, and the other side has a non-pointed sealing surface, preferably made of a softer material, into which the tapered edge presses when the sealing surfaces are in an engaging arrangement. Alternatively or additionally, the sealing structures can have one or more projections, such as humps, peaks, and/or vertices, and recesses to receive such projections to form labyrinths. Optionally, at least one apron-side projection and/or the recess can be arranged on a facial and/or lingual surface section of the outer surface contour.

The sealing structure of the skirt section and the sealing structure of the mold section can be designed to interlock sealingly along at least one contact line, preferably a closed contact line. The sealing structure for interlocking sealing with the sealing structure of the mold section can at least partially define the mold cavity.

The mold cavity can be a hollow space (also: cavity, mold chamber) designed to be filled with a material (secondary material and/or mold filler). It should be noted that filling the mold cavity may not only occur after the skirt section and the mold section have been brought into an interlocking arrangement, but the filler material can, for example, be poured in a viscous form into a space formed by the mold section. The skirt section can then be brought into the interlocking arrangement with the mold section, thus achieving overmolding through a die-casting-like process. Generally, filling the mold cavity and ensuring that the filler material (secondary material) covers the electronic components mounted on the attachment surfaces can also be referred to as overmolding.

The person in question may be a patient, for example, in a dental practice, a sleep medicine practice, and/or a neurology practice. The smart dental device may include a therapeutic device, such as a dental treatment device. The dental treatment device may include: a splint (also known as an occlusal splint and/or intraoral splint, such as a Michigan splint), a protective splint (in particular, an aligner-type protective splint, a sports splint, and/or a night guard), a retainer, a dental brace, and/or an anti-snoring device.

Alternatively or additionally, the smart dental device may include a device for monitoring the patient's medical condition (e.g., with one or more electroencephalography, EEG, and/or electrocardiography, ECG sensors, and/or one or more sensors for monitoring the occurrence of an epileptic seizure). Furthermore, the smart dental device may alternatively or additionally include a speech recording device, a dictation device, and/or a telecommunications device (e.g., a microphone, antenna, and/or loudspeaker).

The intelligent dental device (and/or the apron section and/or the mold cavity) can, in one embodiment, be positioned along a surface contour (e.g., an inner one) that essentially covers the entire tooth surface topology of the individual (e.g., encompassing the individual's left and right molar regions, the individual's left and right canine regions, and the individual's incisor region). This embodiment can ensure a particularly stable hold of the intelligent dental device on the individual's tooth surface topology. Alternatively or additionally, only a microprocessor and energy storage unit may be required, with the sensors and/or feedback components being attached to both (especially left and right) molar regions.

The apron section and/or the at least one apron-side sealing structure can be defined such that it is arranged along at least one molar region of the outer surface contour. Optionally, the apron section and/or the at least one apron-side sealing structure can be defined such that it is located along at least one molar region of the outer surface contour. Similarly, the mold cavity can be provided along at least one molar region of the outer surface contour. Optionally, the mold cavity can be provided along at least both molar regions of the outer surface contour.

The intelligent dental device (and/or the apron section and/or the mold cavity) can essentially cover only one molar region or both molar regions separately. This embodiment can be particularly material-efficient and/or avoid design problems that can arise from the need for a very thin incisor sector. In this embodiment, a separate microprocessor and a separate energy storage unit may be required for each molar region. Alternatively or additionally, the apron section data set and the mold section data set may each contain a separate data set for each molar region. The fabrication of the intelligent dental device according to this embodiment may involve the separate fabrication of one molar region of the intelligent dental device.

The at least one projection and/or recess allows the position and/or orientation of the skirt section relative to the mold section (or vice versa) to be detected and/or controlled, e.g., by an automated manufacturing device. This facilitates assembly and The sealing engagement of the apron section and the mold section and, optionally, the filling of the mold cavity are carried out with very high precision to individually adapt the intelligent dental device to the opposing occlusal surface of the person, and optionally using an automatic procedure.

The apron section digital data set can also define at least one apron-side retention structure designed for mutual interlocking with a mold-side engagement structure of a mold area. This at least one apron-side retention structure can enable a sealing engagement between the apron-side sealing structure and the mold-side sealing structure of the mold section. The apron-side retention structure and the mold-side engagement structure can be arranged in mutually interlocking engagement. In particular, the apron section and the mold section can be held in position relative to each other by means of at least one projection and/or a recess, such as a pin/socket or socket/recess arrangement with a locking effect (e.g., for sealing engagement). The at least one projection and/or the at least one recess can be arranged on or near the sealing structures.

The apron section digital data set can also define at least one registration mark and/or at least one registration pin. Optionally, the at least one registration mark and/or the at least one registration pin can be located on a facial surface section. In another embodiment, at least one registration mark and/or one registration pin can be located on both the lingual surface section and the facial surface section.

The at least one fiducial mark (also: locating element) can consist of a pin and/or a groove. The at least one fiducial mark can be used for automated machining by enabling the registration of the position and orientation of the manufactured workpiece in a downstream machining step, such as a subtractive machining center, a robot-assisted handling or manufacturing device, or the like.

In this process, a workpiece obtained from the filling of the mold cavity—that is, one in which the electronic components have been overmolded with the second material, for example—can be machined with very high precision to individually adapt the intelligent dental appliance to the patient's opposing occlusal surface. Advantageously, the correct positioning and orientation of the workpiece within the subtractive machining device can be ensured using the registration marks. This also ensures that at least one electronic component remains completely covered after machining and that the individually adapted intelligent dental appliance is manufactured with very high precision.

The intelligent dental device can be achieved through the finishing of the workpiece in such a downstream processing step. This finishing can specifically include the fine-tuning of an occlusal surface section of the intelligent dental device after the mold has been filled to form the occlusal surface section.

The apron section digital dataset may further include at least one support structure that enables the additive manufacturing of the apron section. This support structure can facilitate the additive manufacturing process, particularly in the presence of undercuts (e.g., due to a reduced tooth diameter at a tooth neck, which is part of the individual's tooth surface topology). Optionally, the support structure may be arranged along an occlusal, facial, and/or lingual surface section of the apron section's outer surface contour.

The at least one support structure may include auxiliary supports, pins, abutments, and/or columns. Alternatively or additionally, the at least one support structure may be designed to be easily removed, for example, by grinding or milling before assembly with the mold section to form the mold cavity, in particular for filling the mold cavity with a second material that differs from the first material used for the (additive) production of the skirt section.

The definition of one or more attachment surface sections can define one or more protrusions, one or more depressions and/or one or more cavities on the second surface section.

The one or more attachment surface sections can be provided on the facial surface, the occlusal surface and/or the lingual surface of the second surface section. In particular, the attachment surface sections can tend to be arranged in the molar region, at least in the direction of the molar region of the surface definition of the digital data set according to the invention.

Alternatively or additionally, one or more mounting surface sections can have one or more recesses and/or pockets (also: pouches and/or gaps). After the skirt section has been overmolded with the molding material, pockets, pouches, and/or gaps can help to better protect the at least one attached electronic component from the ingress of fluids and/or from mechanical stress.

Mounting surface sections featuring protrusions, recesses, and/or cavities can enable or at least facilitate more precise positioning and/or fixing of the electronic component with high precision. Alternatively or additionally, the electronic component can be attached to one or more mounting surfaces with an adhesive, for example, double-sided adhesive tape applied to the mounting surface section before the electronic component is placed.

Alternatively or additionally, one or more mounting surface sections can have one or more spacers. The one or more spacers can, for example, ensure that after the mounting of the at least one electronic component, a hollow space remains that at least partially surrounds the at least one electronic component and can be filled with a molded cavity filler material, or can even be designed to remain unfilled (e.g., to create a gas-filled gap in the material).

The at least one electronic component is preferably attached to the facial side of the outer surface contour and/or in the molar area of the individually adapted intelligent dental device, since there is preferably a certain anatomical gap in this area which helps to avoid space and/or thickness limitations in the intelligent dental device.

At least part of the one or more attachment surfaces can have a meandering section for attaching at least one electrical or optical conductor. The meandering shape can be individually adapted to the person's tooth surface topology and can be designed to achieve, for example, a specific overall length, capacitance, or inductance.

The at least one electronic component can have at least one electrical or optical connection (also: conductor). By using a meandering conductor path, a standardized length of the at least one electrical or optical connection can be achieved despite variations in patient anatomy. The at least one connection can thus be individually adapted to the dimensions and shape of the dental arch and the tooth surface topology of the person by adjusting the meandering shape accordingly.

Thus, the intelligent dental device can contain several electronic components, which may be pre-assembled and/or a standardized electronic unit, e.g. an energy storage unit, a microprocessor, a sensor system, an actuator, a transmission component and at least one electrical connection that connects these components to each other and/or to the energy storage unit (also: power source).

The outer surface contour of the skirt section can have a predefined surface roughness and/or predefined surface features, such as protrusions and/or depressions, for physical interaction with the filling material of the mold cavity (e.g. the second material).

Such a predefined surface roughness can lead to an increase in the contact area between the material forming the outer surface contour and the filler material. In this way, the physical engagement of the skirt section, i.e., the first material, with the filler material of the mold cavity, e.g., the second material, can be improved.

Alternatively or additionally, the predefined surface features, in particular the protrusions, depressions and/or cavities, improve the physical engagement of the skirt section (especially the first material) with the mold cavity filling material (especially the second material).

The tooth surface topology can be maxillary. Alternatively or additionally, the tooth surface topology can be mandibular. In a first embodiment, the intelligent dental device can, for example, be individually adapted to fit the person's maxillary tooth surface topology. In a second embodiment, the intelligent dental device can be individually adapted to fit the person's mandibular tooth surface topology. In a third embodiment, the intelligent dental device can be individually adapted to fit both the maxillary and mandibular tooth surface topologies of the person.

In one embodiment, the intelligent dental device can be designed for use only with 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 intelligent dental device, in particular the side opposite the inner surface contour, can be designed to correspond with the occlusal surface of the opposing jaw.

In another embodiment, the intelligent dental device can be designed for use with both jaws (i.e., upper and lower jaw). In this case, the outer surface of one jaw section of the intelligent dental device can correspond to the outer surface of the other jaw section of the intelligent dental device.

In another embodiment, each jaw-side section of the intelligent dental device can have at least one electronic component, such as at least one sensor in one jaw-side section and at least one feedback component in another jaw-side section. Optionally, the electronic components of the multiple jaw-side sections can be configured to communicate with each other, enabling them to work together.

In a second aspect of the invention (a first device aspect), an apron section of a custom-fitted intelligent dental device is provided for a person. The apron section fits closely to at least one facial, lingual, and/or occlusal tooth surface topology of that person. The apron section has an inner surface contour that is custom-fitted to match the facial, lingual, and/or occlusal tooth surface topology. The inner surface contour comprises an occlusal surface, a facial surface, and a lingual surface. The inner surface contour forms an inner surface of the apron section. The apron section also has an outer surface contour.

The outer contour has one or more mounting surface sections for attaching at least one electronic component. The outer surface contour of the skirt section has at least one skirt-side sealing structure designed to engage with a mold-side sealing structure of a mold section. The skirt-side sealing structure has a boundary line of a mold cavity, which is defined by at least a portion of the outer surface contour of the skirt section as a section of the inner mold cavity contour.

The apron section can be defined by the apron section digital data set according to the first aspect of the invention.

In a third aspect of the invention (a first method aspect), which may be partially computer-implemented, a method is provided for manufacturing an apron section that is individually adapted to match a person's facial, lingual, and/or occlusal tooth surface topology according to the first device aspect (or the second aspect of the invention). The method includes a step of controlling a manufacturing device for producing the apron section using a first material. The manufacturing can be carried out using an additive manufacturing process, such as 3D printing.

The method may further comprise a step of loading the apron section digital data set of the first aspect of the invention into a memory of a manufacturing facility that implements the manufacturing process.

The individually customized intelligent dental appliance can be manufactured in several steps. For example, the apron section (e.g., from a first material) and a molded section can be produced. (e.g., from an auxiliary molding material) can be manufactured separately. At least one electronic component can be attached to the apron section.

The apron section and the mold section can then be arranged to interlock in a sealing manner, forming a mold cavity that is filled (e.g., with a second material, also known as mold cavity filler, or simply filler). Finally, the mold section can be removed, for example, in a subtractive manufacturing process, or it can be retained if it is manufactured for multiple uses (e.g., from metal). In some embodiments, fine-tuning (and/or refinement) of the occlusal surface of the smart dental device can be performed at the end of the manufacturing process (e.g., manually by a dentist).

The fabrication of the apron section may involve additive manufacturing. The apron section can be produced using a primary material, for example, by forming a film. The film may be made of a thermoplastic material or another polymeric material that can be cured or solidified to retain a shape given in a soft/deformable state. The film may be placed over a positive impression of at least a portion of the individual's tooth surface topology, such as the facial, lingual, and/or occlusal tooth surface topology in the labial and/or molar region.

The manufacture of the skirt section can further include the steps of additive manufacturing, wherein, according to the loaded skirt section digital data set and using a first material, at least one skirt-side retention structure, at least one registration mark and/or a predefined surface roughness and/or predefined surface features are produced.

The first material can be hard or soft. Alternatively or additionally, the first material can be hard at room temperature, medium-hard at 37°C, and medium-soft at a warm water temperature of 45°C to 55°C. The first material can be, for example, a thermoflex material, a thermoplastic material, a resin, and/or a photopolymer.

The hard material can, for example, have a flexural strength between 10 MPa and 100 MPa (and/or be defined by this). For example, a photopolymer (especially the one marketed under the name "KeySplint Hard") can have the physical properties of an elastic modulus (also: Young's modulus) between 1510 MPa and 1520 MPa (e.g., according to ISO 20795-2), a flexural strength between 60 MPa and 65 MPa (e.g., according to ISO 20795-2), and/or a water absorption of 18 micrograms/ ^mm³ (e.g., according to ISO 20795-2).

The first material and/or a mold cavity filling material (and/or the second material) can be (and/or consist of) a biocompatible material, such as a biocompatible resin.

Biocompatible plastics that can be (or are suitable for) the hard material (and/or hard material component(s)) include acrylic, acrylate, methacrylate, cyclic olefin polymer (COP), cyclic olefin copolymer (COC), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), polycarbonate (PC), polypropylene (PP), polyethylene terephthalate (PET), polyimide, polyetherimide (PEI), nylon, and/or Ultem. The hardness can typically range from 2000 MPa to 3500 MPa (e.g., for the modulus of elasticity) for a dental hard bite appliance (e.g., a splint). Milled acrylic can typically be harder than a printed and/or thermoformed dental appliance (such as a splint) and can optionally be considered a target value. For example, milled acrylic can have a modulus of elasticity of approximately 3100 MPa.

The soft material can, for example, have a flexural strength between 2 MPa and 4.5 MPa (and/or be defined by this). For example, a biocompatible 3D printing resin (especially the one marketed under the name "KeySplint Soft") can have the following physical properties: a Shore hardness of 82 (e.g., on scale D), a modulus of elasticity of 1356 MPa (e.g., on ASTM D790), a flexural strength between 2.6 MPa and 4.4 MPa (e.g., on ISO 20795-2), and/or a water absorption of less than 18 µg/ ^mm³ (e.g., on ISO 20795-2).

The soft material can be (or contain) a thermoplastic polyurethane (TPU), COP, silicone, acrylate, and/or methacrylate. A hardness range for the soft material can often be measured differently than a hardness range for hard materials (e.g., using the Young's modulus) and can be specified, for example, as a Shore hardness for the soft material. At room temperature (e.g., approximately 20°C to 22°C) The soft material (e.g. KeySplint Soft) may be relatively hard, but become softer when placed in warm water and/or in the human oral cavity.

The process can further include a step of providing, i.e., defining in the digital data set and subsequently manufacturing, a support structure for the production of the skirt section, preferably by additive manufacturing. Optionally, the support structure can be meltable or solvent-soluble to allow its removal after the skirt section has been manufactured. Optionally, the support structure can be removed by milling, grinding, cutting, or another subtractive process.

The support structure can be applied either as an alternative or in addition to the fabrication of the apron section. This further facilitates the fabrication of the apron section with high dimensional accuracy. The (meltable or dissolvable) support structure can be used to adapt/support the inner surface contour. It can be removed, for example, by melting or dissolving, before a further step of the process is carried out, such as before the attachment of the at least one electronic component. If the support structure is intended to conform to the inner surface contour, it can be removed after the fabrication of the smart dental device, for example, by melting or dissolving.

The material of the support structure can therefore differ from the first and second materials used to manufacture the smart dental device, in order to allow for its melting or dissolution. In particular, the support structure material can be softer, have a lower melting point than the first and second materials, and/or be soluble in a solvent (that does not attack/dissolve the first and second materials).

The support structure produced according to the apron digital data set can extend outwards from the outer surface contour of the apron section, particularly towards the outer mold contour. Removing the support structure of the apron section can be incorporated into the milling/grinding and/or polishing process of the outer surface contour. In some embodiments, it may be sufficient to remove the additively produced support structure only partially, for example, by leaving remnants on the outer mold contour.

The skirt section of the first device aspect (second aspect of the invention) can be manufactured according to the method according to the first method aspect (third aspect of the invention).

In a fourth aspect of the invention (a second aspect of the digital data set), a mold section digital data set is provided for use in the manufacture of an occlusal section of a customized smart dental device that closely matches at least one facial, lingual, and/or occlusal tooth surface topology of a person. The occlusal section corresponds to at least one opposing occlusal tooth surface topology of the person.

The mold section digital dataset defines an inner surface contour of the mold section. The inner surface contour of the mold section is individually adapted (or designed) to correspond at least to the occlusal shape of the person's opposing dental arch. The mold section digital dataset also defines an outer surface contour of the mold section. The outer surface contour of the mold section defines at least one mold-side sealing structure designed to engage with an apron-side sealing structure of a surface contour of an apron section, which is defined by an apron section digital dataset according to the first aspect of the digital dataset. The mold-side sealing structure defines a boundary line of the mold cavity, which is defined by at least a portion of the mold section's inner surface contour as a section of the inner mold cavity contour.

The form section digital data set can be embodied on a volatile or non-volatile storage medium or on a carrier wave in packetized form, such as in TCP/IP packets, or as a stream, such as a UDP stream.

According to the present disclosure, the term “sealing interlock” refers to a state of interlocking of the two units, i.e., the skirt section and the mold section, in which they are joined to form a mold cavity which is essentially fluid-tight, but may also contain certain openings to allow the escape of material.

The mold section digital data set can contain surface boundary information (e.g., regarding the inner surface contour of the skirt section) for the manufacture of the skirt section.

At least portions of the inner surface contour of the mold section and the outer surface of the apron section can define (or provide) the mold cavity, which is designed to receive or be filled with the mold cavity filling material, such as the second material. The first material of the apron section and the second material, i.e., the mold cavity filling material, can be designed to adapt and/or connect to form the outer shape of the smart dental device. The inner surface contour of the mold section can be defined to match the occlusal shape of the patient's opposing dental arch, which may include the occlusal surface of the opposing tooth topology.

The inner surface can also be defined as a standardized surface, e.g., a surface that does not precisely match the opposing tooth topology but allows for further refinement and adaptation to the opposing tooth topology through subsequent processing, e.g., subtractive machining (e.g., milling or grinding). For example, the standardized inner surface of the mold section can have a flat occlusal surface. Alternatively or additionally, the standardized inner surface of the mold section can have a smooth lingual surface and/or a smooth facial surface, particularly without depressions between adjacent teeth.

The mold section digital data set can further define at least one fluid connection gating system extending from the outer surface contour of the mold section to the inner surface contour of the mold section. Such a sprue (also: filling hole and/or outlet) can have a conduit for filling the mold cavity with mold cavity filler material, such as the second material. Alternatively or additionally, the at least one sprue can have an outlet for air, for venting and/or pressure equalization (e.g., during filling of the mold cavity with the mold cavity filler material, in particular the second material).

The section of the gating system (and/or parts of the surrounding outer contour) located towards the outside of the mold section, i.e., the mold material inlet, can be designed to incorporate a suitable connection structure to ensure a secure connection to a mold filling material source, such as an injection nozzle or similar device. This connection structure can take the form of a thread, a bayonet fitting, or another suitably designed connector to guarantee a secure connection of the filling material source during the injection (or infiltration) process.

The outer surface contour of the mold section can define a standardized outer shape. In particular, the standardized outer shape can be circular (e.g., preferably with a predetermined radius), polygonal, and/or arc-shaped (e.g., preferably with a predetermined size and shape). The standardized outer shape can be selected depending on the choice of manufacturing equipment (and/or container, e.g., with a circular shape) that can be used for the subsequent processing or handling of the mold section (whether or not it is sealingly engaged with the skirt section).

Alternatively or additionally, e.g. to save on auxiliary mold material in the production of the mold section, the mold section can have an inner surface contour of the mold section digital data set which is essentially parallel (i.e. running in approximately the same direction) to the outer surface contour of the mold section in at least equal parts of the mold section.

The at least one mold-side sealing structure can define at least one recess and/or projection designed to engage sealingly with at least one corresponding projection and/or recess of the skirt-side sealing structure. Optionally, the at least one mold-side recess and/or projection can be located adjacent to a facial and/or lingual surface section of the inner surface contour. The matching recesses and projections of the mold section and the skirt section enable a sealing engagement of the mold section and the skirt section to fill the mold cavity after assembly.

In a fifth aspect of the invention (a second device aspect), a mold section is provided for the production of a customized intelligent dental device for one person. The molded section has an inner surface contour. The inner surface contour of the molded section is individually adapted to correspond at least to the occlusal shape of the person's opposing dental arch. The molded section also has an outer surface contour. The outer surface contour of the molded section has at least one mold-side sealing structure designed to engage sealingly with an apron-side sealing structure of a surface contour of an apron section according to the first device aspect. The mold-side sealing structure defines a boundary line of the mold cavity, which is formed by at least a portion of the inner surface contour of the molded section as a section of the inner mold cavity contour. The molded section can be manufactured according to the method described in this second method aspect.

The mold section can be defined by the mold section digital data set according to the second aspect of the digital data set (the fourth aspect of the invention).

In one embodiment, the method for manufacturing a mold section for producing a customized intelligent dental appliance for a person, as described in the second appliance aspect, is at least partially implemented by a suitably programmed computer. In this embodiment, the method includes a step for controlling the manufacturing device for producing the mold section, for example, by additive manufacturing such as 3D printing. The method may further include a step in which a mold section digital data set is loaded into a memory of an additive manufacturing device.

The manufacturing of the mold section can further include a step in which at least one fluid connection gating system is produced according to the loaded mold section digital data set. Thus, the mold section can have at least one channel designed as a gating system for filling the mold cavity with the filling material during the manufacture of the intelligent dental device (and/or at least its occlusal surface). Alternatively or additionally, the mold section can have additional channels for venting or pressure relief to ensure proper filling of the mold cavity after the mold section and skirt section have been assembled for a sealing fit.

The molding material (also: auxiliary molding material) can be chosen independently of the first material for the production of the apron section and the mold cavity filling material, i.e. the second material, for the production of at least the occlusal surface of the individually adapted intelligent dental device.

The forming material (and/or the second material) can be made of a hard material. The hard material can be, for example, a hard acrylic material.

In a sixth aspect of the invention (third method aspect), a method for manufacturing a customized intelligent dental device for a person is provided by using an apron section according to the first device aspect and a mold section according to the second device aspect. This method can be partially implemented by a suitably programmed computer.

The method comprises a step of attaching at least one electronic component to one or more attachment surface sections of the outer surface contour of the skirt section. The method further comprises a step of attaching the molded section to the skirt section (also: assembly), which incorporates the attached at least one electronic component to define a molded cavity. The assembly includes the sealing engagement of the at least one sealing skirt-side sealing structure of the skirt section with the at least one mold-side sealing structure of the molded section.

The process further includes a step of filling the mold cavity with a filling material (also: mold cavity filling material). The filling with the filling material can take place after the assembly of the mold section with the skirt section, or alternatively, the filling material can be applied before the assembly of the mold section and the skirt section, and the material then escapes, for example, through pressure relief channels, vents, or gaps provided for this purpose in the seal when the mold section and the skirt section are assembled.

The process may further include a step of solidifying or curing the filling material, thereby creating an occlusal section of the smart dental device that fluid-tightly embeds the at least one electronic component. The process also further includes a step for removing the molded section.

The process may involve applying an adhesive (also: adhesion promoter, binder and/or rheological additive) to the part of the outer surface contour of the skirt section that defines part of the contour of the mold cavity.

Alternatively or additionally, the process may include a step of applying a mold release agent to the part of the inner surface contour of the mold section that defines part of the contour of the mold cavity.

In one embodiment, at least some of the attached electronic components can be fixed in place by filling a cavity, bag, and/or pocket, designed as an attachment surface section, with mold filling material before the mold section is attached to the skirt section. This secures the electronic component and ensures that correct positioning is maintained during the filling process.

The procedure according to the sixth aspect provides an individually adapted dental device that has fluid-tight (e.g., waterproof and/or saliva-protected) sealed electronic components, such as an energy storage unit, a microprocessor, sensors, power connections, actuators and/or similar, and is optimally adapted to the person's dental status.

The process for manufacturing the individually customized intelligent dental appliance can utilize CAD/CAM, for example, in the processes for manufacturing the apron section and/or the mold section. Thus, the sixth aspect of the process can use CAD for the apron section digital dataset (e.g., for adaptation to the individual's tooth topology) and/or for the mold section digital dataset and/or for the attachment of at least one electronic component and/or for milling the mold cavity material (e.g., the second material) after filling the mold cavity. Alternatively or additionally, the mold section digital dataset can use a digital bite finder for alignment with the individual's opposing occlusal surface.

The first material used to fabricate the apron section may be softer and/or more flexible than the material used to fill the mold cavity, i.e., the second material. The first material may be specifically chosen for optimal fit and/or comfort to the individual's dental topography.

The mold filling material, i.e., the second material, can be selected to possess sufficient strength to protect the at least one electronic component and/or to ensure a long service life for the smart dental device (e.g., at least two years, preferably at least five years, if worn daily). In particular, the occlusal surface of the smart dental device is advantageously made of a resistant material, as the person's jaws exert potentially high compressive and shear/abrasive forces during bruxism. The mold cavity filling material, such as the second material, can be a hard material. For example, the hard material could be a hard acrylic.

An undercut area, e.g., due to a reduced tooth diameter in a cervical region contained in the person's tooth surface topology, may contain only the first material; only comparatively low shear/abrasive forces act on this part of the intelligent dental device.

The process can be carried out in a laboratory, e.g., in a dental laboratory and/or a manufacturing workshop. Alternatively or additionally, the external geometry of the workpiece (i.e., the intelligent dental device) can be manually fine-tuned and/or polished by a specialist, e.g., a dentist and/or a dental technician.

Alternatively or additionally, the external geometry of the workpiece (i.e., the intelligent dental device) can be manually fine-tuned and/or polished by a specialist, e.g., a dentist and/or a dental technician.

The apron section, together with the mold cavity filler material (i.e., the second material), can be considered an unfinished part, for example, if burrs are present at the transition between the first material and the mold cavity filler material and/or other areas of the smart dental appliance. The custom-made smart dental appliance can also be considered a finished part.

In one embodiment, the method may, in particular after the filling material has been poured into the mold cavity and the filling material has been cured, solidified, or allowed to harden, include a further step of removing at least one sealing structure of the apron section. Alternatively or additionally, the method may also include a step of removing at least one retention structure and/or at least one locating mark of the apron section. Alternatively or additionally, the method may further include a step of removing at least a portion of the mold section and/or a step of fine-tuning and/or removing at least a portion of the occlusal section of the smart dental device. The removal may be carried out by a suitable subtractive process, e.g., by milling, grinding, cutting, blasting, fracturing, etc.

For example, the at least one projection of the sealing structure of the apron section may only be required for the sealing engagement with the mold section during filling of the mold cavity. Afterwards, the at least one projection can be removed to ensure a comfortable fit of the smart dental device in the person's oral cavity.

The at least one electronic component can comprise an energy storage unit (e.g., electrical), a microprocessor, at least one sensor, and connections (e.g., electrical) for supplying energy (e.g., electrical) from the energy storage unit to at least the microprocessor and the at least one sensor. Optionally, the energy storage unit can be wirelessly rechargeable. Alternatively or additionally, the at least one electronic component can operate optically and/or using light.

The at least one electronic component (e.g., the energy storage unit, the microprocessor, the at least one sensor, and/or the connectors, especially when they are arranged together on a surface mounting section, such as on a facial side of the apron section) can be embodied by a printed circuit board (PCB), which may be flexible to adapt to the curvature of appropriately shaped mounting sections of the smart dental device. The PCB may, for example, contain several sensors. The PCB may be connected to other sensors via wires (e.g., for power and/or data connections) and/or flexible circuit boards, as in the case of occlusal force measurement.

The printed circuit board (PCB) can have a length between 5 mm and 35 mm and/or a width between 3 mm and 15 mm (and/or L × W: e.g., 5 × 3 ^mm² to 35 × 15 ^mm² ). Preferably, the length of the PCB is less than 20 mm and the width of the PCB is less than 10 mm (and/or less than 20 × 10 ^mm² ). The thickness of the PCB can be between 1 mm and 5 mm, depending on the application.

The at least one electronic component may alternatively or additionally include a light source (e.g., an LED, an OLED, a laser diode, etc.). The light source may be activatable, for example, to correctly position the smart dental device in the person's mouth and/or to locate the smart dental device, e.g., in the dark. Other uses for activating the light source may be appropriate, such as performing chemical (e.g., spectral) analyses of the person's saliva, breath, or skin within the oral cavity.

The at least one sensor can consist of at least one sensor pad and/or at least one sensor film. The sensor can measure pressure, force (e.g., shear force), luminous flux, spectral components of light, temperature, acceleration, spatial orientation, sound, electromagnetic waves, etc. In particular, the at least one sensor can be, for example, a temperature sensor, a biosensor, an ultrasonic sensor, an oxygen saturation sensor, a pH sensor, an ion sensor, a humidity sensor, an ECG sensor, a respiration sensor, a heart rate sensor, a blood pressure sensor, an electroencephalographic (EEG) sensor, and/or an infrared (IR) sensor.

The thickness of the at least one sensor, particularly for use along the occlusal surface of the intelligent dental device, can be in the range between 0.05 mm and 0.5 mm, preferably between 0.1 mm and 0.4 mm, and most preferably between 0.2 mm and 0.3 mm.

The at least one sensor may be a sensor suitable for detecting bruxism. This at least one sensor may be, for example, a pressure sensor, a force sensor, a motion sensor, a sound sensor, an optical sensor, and/or a camera.

The at least one sensor can be designed to detect the person's health status, such as the onset of an epileptic or convulsive seizure, e.g., in time for taking preventive medication, applying (or monitoring the application of) electrical stimulation, or similar measures.

The at least one sensor can be, for example, a temperature sensor, a biosensor, an ultrasound sensor, an oxygen saturation sensor, a pH sensor, an ion sensor, a humidity sensor, an ECG sensor, a respiratory sensor, a heart rate sensor, a blood pressure sensor, an electroencephalographic (EEG) sensor and/or an infrared (IR) sensor.

At least one electronic component can be at least partially flexible. For example, electrical connections can be at least partially flexible, and/or a sensor pad and/or a sensor film can be at least partially flexible.

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

The at least one electronic component can include a communication unit. Optionally, the communication unit can include an antenna for wireless data transmission. The data can, for example, be collected over a period of time using the at least one sensor and stored in the memory of the intelligent dental device, in order to be read out later using the communication unit.

The communication unit can be designed for the wireless transmission (e.g. via Bluetooth, WiFi, near field communication and/or a telecommunications network such as 4G/5G/6G) of data, especially sensor data.

The communication unit can be designed to communicate with an external device, such as that used by a dentist, sleep specialist, and/or neurologist. This allows the individual and/or the doctor to monitor the individual's bruxism, sleep patterns, and/or overall health.

The data may include information received by the smart dental device from the patient's device and/or the dentist's device. The data received by the smart dental device may, for example, include instructions to activate at least one feedback component, such as an actuator, e.g., to generate vibrations to reduce bruxism.

The at least one sensor can be designed to detect the person's health status, such as the onset of an epileptic or convulsive seizure, e.g., in time for taking preventive medication, applying (or monitoring the application of) electrical stimulation, or similar measures.

Electronic components such as the printed circuit board and/or circuit board with one or more microprocessors, the energy storage unit (also: batteries) and/or large-area components such as an antenna, e.g. for near field communication (NFC), may preferably be placed in the facial-buccal section of the intelligent dental device.

One or more occlusal force sensors can be placed in the occlusal posterior (and/or buccal) area and, more preferably, in one (or all) of the occlusal contact areas.

One or more additional sensors (e.g., other than occlusal force sensors) can be used, for example, in the area of an approximal position, such as sensors to determine the presence of carious lesions or biofilms, e.g., in the interdental space. Alternatively or additionally, further sensors can be used, such as blood oxygen sensors, perfusion and/or blood pressure sensors, and positioned so that they extend towards and/or are in contact with the gingiva, lingually, and/or on the palate. Sensors placed in contact with soft tissue, such as the gums or palate, can provide information about the physical condition of the person wearing the device.

Alternatively or additionally, all sensors can be placed on a circuit board and/or switching board, preferably on the buccal side and/or as small bands around a tooth.

The at least one electronic component can be attached using an adhesive, such as tape or a pad. Using an adhesive to attach the at least one electronic component allows for highly precise positioning. This can improve the performance of the at least one sensor, e.g., with regard to acquiring sensor data, and/or the at least one feedback component (e.g., providing mechanical feedback via at least one actuator).

A minimum wall thickness of the skirt section can be in the range of 0.5 mm to 1.5 mm, preferably less than 1 mm (e.g., between 0.5 mm and 1 mm). Alternatively or additionally, a minimum thickness of the outer surface, e.g., the surface made from the second material, can be 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 do cover electronic components.

The material thickness of both the individual layers of the first and second materials, as well as the overall thickness of the smart dental appliance, can be selected based on requirements such as the mechanical stresses that may occur in the area, the mechanical properties the appliance must fulfill (e.g., the tension that must be maintained in a retention splint), its position, etc. For example, it is generally undesirable, and may not even be necessary, to design the appliance with a thick material layer in the anterior region, whereas it is unproblematic to include a thick material layer (including electronic components, etc.) in the buccal region of the appliance. Accordingly, the material layers can be selected to have different dimensions along and/or across the entire smart dental appliance.

By combining the two layers, i.e., the second material covering the first material, both the facial-labial (also: facial-anterior) section and the lingual section of the intelligent dental appliance can be kept as thin as possible, e.g., below 1.5 mm.

The facial-buccal section and the occlusal section can be less than (or at most) 4 mm thick in total (excluding recess, pocket, pouch and/or gap for the at least one electronic component). Some areas of the smart dental device may be intentionally designed to have a thicker layer of material than others to create a seamless and rounded transition to the extrusions (e.g., a recess, pocket, pouch and/or gap) in which the electronic components are embedded.

In the posterior occlusal section, the thickness of the material layer can preferably be less than 2 mm.

The apron section made from the first material and the section formed from the second material can be joined by a form-fitting and/or material-fitting connection (e.g. material joining).

Printed dental resins, such as (e.g., meta-)acrylates for the first material, can be used with 2K or photo-initiated acrylate dental products (such as BMS 016, Dentamid fixtemp, and/or Dentamid FotoDent) for the second material. Alternatively or additionally, nonpolar first materials such as COPs can also be readily bonded to nonpolar second materials (such as COP and others). COPs can be formulated with different hardness levels for the first and second materials. Furthermore, older Natively or additionally printed nylons (e.g. polyimide) can be used for the first material with a heat-curing polyimide resin (e.g. as a second material).

In this way, at least one electronic component can be enclosed in the intelligent dental device in an airtight and/or watertight manner.

Covalent bonding can be facilitated by activating the surface of the first material through corona, plasma, or other surface treatments that generate functional groups on the surface. This can be done before assembly (also known as electronic placement) with shielding of the (e.g., sensitive) electronic components, or using another compatible method.

The skirt section made from the first material and the section formed from the second material can be joined in a sealed configuration. For example, the skirt section made from the first material and the section formed from the second material can be joined in a fluid-tight and/or airtight configuration. This allows the at least one electronic component to be sealed against the ingress of fluids such as saliva, water, or air.

The fluid-tight and/or airtight sealing of the at least one electronic component can enable a long service life for the at least one electronic component and/or ensure that the at least one electronic component is not damaged by oxidation. Alternatively or additionally, the fluid-tight and/or airtight sealing of the at least one electronic component can ensure that potentially toxic substances (e.g., from the energy storage device) do not enter the person's oral cavity.

The third aspect of the invention provides an intelligent dental device. The intelligent dental device can be manufactured using the method described in the third aspect of the invention. Therefore, the intelligent dental device can be manufactured using a digital data set. The digital data set of the intelligent dental device can include the apron section digital data set and the mold section digital data set. Alternatively or additionally, the digital data set of the intelligent dental device can also include an arrangement of the at least one electronic component.

The intelligent dental device can be a smart dental treatment appliance. This smart dental treatment appliance can be an occlusal splint (e.g., a Michigan splint) or another bite splint with a flat surface. Alternatively or additionally, the intelligent dental treatment appliance can be a protective splint (e.g., an aligner-type protective splint, a sports splint, and/or a night guard). Alternatively or additionally, the intelligent dental treatment appliance can also be a retainer. As a further alternative or additionally, the intelligent dental treatment appliance can be braces. As a further alternative or additionally, the intelligent dental treatment appliance can be an anti-snoring device and/or a mandibular advancement device.

The intelligent dental device may have an apron section according to the first device aspect, comprising a first material. The intelligent dental device may further have at least one electronic component mounted on one or more attachment surface sections of the apron section, defined, for example, by the digital data set. The intelligent dental device may further have an outer geometric section comprising a second material to substantially conform to an occlusal surface of the opposing occlusal tooth surface topology of the individual. The first material and the second material may be joined in a fluid- and/or gas-tight configuration. This allows the at least one electronic component, but not necessarily all electronic components, to be sealed against the ingress of fluids such as saliva, water, or air.

Each of the procedures described in the first, second, and/or third aspect can be performed in a laboratory, such as a dental laboratory and/or a manufacturing workshop. Alternatively or additionally, the external geometry of the workpiece (i.e., the smart dental device) can be manually fine-tuned and/or polished by a specialist, such as a dentist and/or a dental technician.

The invention also provides a computer program product. The computer program product comprises program elements that cause a manufacturing device to carry out the steps of the method for manufacturing a customized intelligent dental device that closely matches at least one facial, lingual, and/or occlusal tooth surface topology of a person according to the method aspect, when the program elements are loaded into a memory of the manufacturing device.

The invention also provides a computer-readable storage medium or carrier wave that stores or encodes program elements which can be read and executed by a manufacturing device in order to carry out steps of the method for manufacturing a customized intelligent dental device that closely fits at least one facial, lingual and/or occlusal tooth surface topology of a person according to the method aspect, when the program elements are executed by the manufacturing device.

Brief description of the drawings

• 1 ein beispielhaftes Flussdiagramm eines Verfahrens zur Herstellung eines Schürzenabschnitts einer individuell angepassten intelligenten Dentalvorrichtung für eine Person;
• 2 einen ersten beispielhaften Querschnitt eines Schürzenabschnitts, der so individuell angepasst ist, dass er an eine faziale, linguale und/oder okklusale Zahnflächentopologie einer Person passt, z.B. hergestellt nach dem Verfahren aus 1;
• 3 ein beispielhaftes Flussdiagramm eines Verfahrens zur Herstellung eines Formabschnitts für die Herstellung einer individuell angepassten intelligenten Dentalvorrichtung für eine Person;
• 4 eine erste beispielhafte Querschnittansicht eines Formabschnitts, z.B. hergestellt nach dem Verfahren aus 3;
• 5 ein beispielhaftes Flussdiagramm eines Verfahrens zur Herstellung einer individuell angepassten intelligenten Dentalvorrichtung für eine Person unter Verwendung eines Schürzenabschnitts (z.B. des Schürzenabschnitts aus 2) und eines Formabschnitts (z.B.
• des Formabschnitts aus 4);
• 6 eine beispielhafte Querschnittansicht eines Schürzenabschnitts, z.B. des Schürzenabschnitts aus 2, mit angebrachten elektronischen Komponenten und angebrachtem Formabschnitt, z.B. dem Formabschnitt aus 4, als Herstellungs-Zwischenschritt des Verfahrens aus 5;
• 7 eine erste beispielhafte Querschnittansicht einer intelligenten Dentalvorrichtung, z.B.
• hergestellt nach dem Verfahren aus 5, und/oder nach dem Entfernen des Formabschnitts aus der Anordnung aus 6;
• 8 eine zweite beispielhafte Querschnittansicht eines Schürzenabschnitts, der so individuell angepasst ist, dass er an eine faziale, linguale und/oder okklusale Zahnflächentopologie einer Person passt, z.B. hergestellt nach dem Verfahren aus 1;
• 9 eine beispielhafte Querschnittansicht eines Schürzenabschnitts, z.B. des Schürzenabschnitts aus 8, mit angebrachten elektronischen Komponenten und angebrachtem Formabschnitt, z.B. hergestellt nach dem Verfahren aus 4, als Herstellungs-Zwischenschritt des Verfahrens aus 5;
• 10 eine zweite beispielhafte Querschnittansicht einer intelligenten Dentalvorrichtung, z.B. hergestellt nach dem Verfahren aus 5, und/oder nach dem Entfernen des Formabschnitts aus der Anordnung aus 9;
• 11 eine dritte beispielhafte Querschnittansicht einer intelligenten Dentalvorrichtung, z.B. hergestellt nach dem Verfahren aus 5;
• 12 einen beispielhaften planen Querschnitt einer intelligenten Dentalvorrichtung, z.B. der intelligenten Dentalvorrichtung aus 11, und/oder hergestellt nach dem Verfahren aus 5;
• 13 eine beispielhafte perspektivische Ansicht von elektronischen Komponenten, die gemäß einem Zwischenschritt des Verfahrens aus 5 an einem Schürzenabschnitt angebracht sind;
• 14 beispielhaft elektronische Komponenten mit elektrischen Verbindungen, die Mäanderform haben;
• 15A, 15B und 15C eine beispielhafte perspektivische Ansicht eines Schürzenabschnitts, eine erste beispielhafte Stützstruktur zur Herstellung des Schürzenabschnitts bzw. eine zweite beispielhafte Stützstruktur zur Herstellung des Schürzenabschnitts;
• 16 eine Querschnittansicht einer beispielhaften intelligenten Dentalvorrichtung, die an den Zähnen einer Person angebracht ist;
• 17 eine perspektivische Ansicht der Zahnflächentopologie einer Person mit einer geplanten Abdeckung durch die intelligente Dentalvorrichtung; und
• 18 und 19 beispielhafte nicht-intelligente Dentalvorrichtungen, wie z.B. Schienen, die mit aus dem Stand der Technik bekannten Stützstrukturen hergestellt sind.

Exemplary, non-limiting embodiments are described with reference to the accompanying drawings. These show:

• 1 an exemplary flowchart of a process for manufacturing an apron section of a custom-made intelligent dental device for one person;
• 2 a first exemplary cross-section of an apron section that is so individually adapted to fit a person's facial, lingual and/or occlusal tooth surface topology, e.g. produced according to the procedure from 1 ;
• 3 an exemplary flowchart of a process for manufacturing a mold section for the production of a customized intelligent dental device for one person;
• 4 a first exemplary cross-sectional view of a mold section, e.g. produced according to the method from 3 ;
• 5 An exemplary flowchart of a process for manufacturing a customized intelligent dental device for one person using an apron section (e.g., the apron section made of 2 ) and a molded section (e.g.
• of the mold section 4 );
• 6 an exemplary cross-sectional view of an apron section, e.g. the apron section made of 2 , with attached electronic components and attached mold section, e.g. the mold section made of 4 , as an intermediate manufacturing step of the process from 5 ;
• 7 a first exemplary cross-sectional view of an intelligent dental device, e.g.
• produced according to the process from 5 , and/or after removing the molded section from the arrangement 6 ;
• 8 a second exemplary cross-sectional view of an apron section that is so individually adapted to fit a person's facial, lingual and/or occlusal tooth surface topology, e.g. produced according to the procedure from 1 ;
• 9 an exemplary cross-sectional view of an apron section, e.g. the apron section made of 8 , with attached electronic components and attached molded section, e.g. manufactured according to the method from 4 , as an intermediate manufacturing step of the process from 5 ;
• 10 a second exemplary cross-sectional view of an intelligent dental device, e.g. manufactured according to the method from 5 , and/or after removing the molded section from the arrangement 9 ;
• 11 A third exemplary cross-sectional view of an intelligent dental device, e.g. manufactured according to the method from 5 ;
• 12 an exemplary flat cross-section of an intelligent dental device, e.g. the intelligent dental device from 11 , and/or produced according to the process from 5 ;
• 13 an exemplary perspective view of electronic components, which, according to an intermediate step of the procedure, consist of 5 are attached to a section of the apron;
• 14 Examples include electronic components with electrical connections that have a meander shape;
• 15A , 15B and 15C an exemplary perspective view of an apron section, a first exemplary support structure for the production of the apron section, or a second exemplary support structure for the production of the apron section;
• 16 a cross-sectional view of an exemplary intelligent dental device attached to a person's teeth;
• 17 a perspective view of the tooth surface topology of a person with planned coverage by the intelligent dental device; and
• 18 and 19 Examples of non-intelligent dental devices, such as splints, which are manufactured with support structures known from the prior art.

Detailed description

The present disclosure describes exemplary embodiments of a technique for manufacturing a customized intelligent dental device.

1 Figure 1 shows an exemplary flowchart of a process for manufacturing an apron section of a custom-made smart dental appliance for one person. The process is generally designated by reference numeral 100.

Method 100 further comprises step S104, in which an additive manufacturing device is controlled to additively produce an apron section using a first material. The apron section has an inner surface contour that is individually adapted to match the facial, lingual, and/or occlusal tooth surface topology. The apron section further comprises an outer surface contour that includes one or more attachment surface sections for mounting at least one electronic component. Finally, the apron section has at least one apron-side sealing structure.

Method 100 can include a step S102 for loading the apron section digital data set into a memory of a (e.g. additive) manufacturing device.

Method 100 can include a step S103 of providing a support structure for the additive manufacturing S104 of the skirt section. Optionally, the support structure for the additive manufacturing S104 of the skirt section can be meltable or dissolvable.

Method 100 may further include a step S105 of removing the support structure of the skirt section, which was additively manufactured according to the skirt section digital data set S104. Optionally, the support structure may be removed by milling, grinding, cutting or other subtractive processes.

Step S105, the removal of the support structures, can be performed manually and/or with the help of a robot.

2 Figure 1 shows an exemplary cross-sectional view of an apron section 200. The apron section can be manufactured (e.g., additively) using a first material. The apron section 200 has an inner surface contour 212 and an outer surface contour 214. The inner surface contour 212 (also: tooth contact side of the material of the aid) is designed to closely match the facial, lingual, and/or occlusal tooth surface topology of a person.

The apron section in 2 It also features a mounting surface section (e.g., in the form of a pouch) 216 for one or more electronic components. Reference numeral 218 specifies a sealing structure on the skirt side. Reference numeral 220 schematically depicts a skirt-side boundary of a molded cavity.

The apron section (also: "first 3D-printed part") can be additively manufactured or (e.g., 3D-)printed, particularly using a first material. The first material can be a hard material (e.g., Keysplint Hard) or a soft material (e.g., Keysplint Soft). With the first print or In an additive manufacturing step, a mold (also called a form; e.g., with a partially standardized outer dimension), which in particular defines a mold cavity, can be produced in two pieces. The second piece can be formed by the mold section. The standardized outer dimension can refer in particular to an outer shape of the mold section.

Any support structures (also called printing supports) used to produce the first 3D-printed part can be removed after the additive manufacturing (and/or 3D printing) process is complete.

3 Figure 300 shows an exemplary flowchart of a process for manufacturing a mold section for the production of a customized smart dental appliance for an individual. The process is generally designated by reference numeral 300. Process 300 includes step S304, a (e.g., additive) manufacturing device for (e.g., additive) manufacturing of a mold section using a molding material. The mold section has an inner surface contour designed to correspond at least to the occlusal shape of the individual's opposing dental arch. The mold section also has at least one mold-side sealing structure. The mold-side sealing structure defines a boundary line of the mold cavity, which is formed by at least a portion of the mold section's inner surface contour as a section of the inner mold cavity contour.

Method 300 can include a step S302 for loading the mold section digital data set into a memory of a (e.g. additive) manufacturing device.

4 Figure 1 shows an exemplary cross-sectional view of a mold section 400. The mold section 400 has an inner surface contour 412, which at least partially forms a mold-side boundary of a mold cavity. The mold section 400 also has: an outer surface 414, one or more fluid connection gate channels 416 through which the mold cavity filling material can be introduced into the mold cavity, and a mold-side sealing structure 418.

The outer surface contour has an inlet connection structure 415, which is shaped to ensure a secure connection between the mold section 400 and a mold fluid source during the filling (or infiltration) of the mold cavity with the mold filling material. The connection structure 415 can be shaped such that the connection is maintained even when significant pressure is exerted on the mold filling material during the filling process.

5 Figure 1 shows an exemplary flowchart of a process for manufacturing a customized smart dental appliance for one person using an apron section (e.g., apron section 200) and a mold section (e.g., mold section 400). The process is generally designated by reference numeral 500.

Method 500 includes a step S502 of attaching at least one electronic component to one or more attachment surface sections of the outer surface contour of the skirt section (e.g., the skirt section 200).

Step S502, the placement of the electronic components, can be performed manually and/or with the aid of a robot. Alternatively or additionally, the electronic components can be attached, for example, by frictional adhesion (and/or force-fit connection).

Method 500 further comprises step S504 of attaching the molded section (e.g., molded section 400) to the skirt section (e.g., skirt section 200), which includes at least one electronic component S502 to define a molded cavity. The attachment S504 includes the sealing engagement of the at least one sealing skirt-side sealing structure of the skirt section (e.g., skirt section 200) with the at least one mold-side sealing structure of the molded section (e.g., molded section 400).

Method 500 further includes a step S506 in which the mold cavity is filled with a mold cavity filling material (also: second material).

Furthermore, procedure 500 includes a step S508 of removing the mold section (e.g., mold section 400).

The procedure 500 may include a step S507 of curing the filling material or allowing the filling material to cure, thereby creating an occlusal section of the intelligent dental device that fluidly embeds the at least one electronic component.

The intelligent dental device can be manufactured using CAD/CAM. For example, the steps of the procedure can be... 5 performed using CAM.

6 Figure 1 shows an apron section 200 with an attached molded section 400. Before the molded section 400 was attached, electronic components 630-1 and 630-3 were attached (also: placed) on a facial side (e.g., comprising a microprocessor, an energy storage unit, a sensor, and/or an antenna), or on an occlusal side (e.g., comprising one or more sensors, in particular a pressure sensor and/or force sensor), and connected by an electrical connection 630-2 as a further electronic component. Alternatively or additionally, the electronic components (e.g., comprising sensors) 630-1, 630-2, and 630-3 can be fixed, e.g., with form-fitting adhesive tape.

The mold cavity in 6 The cavity is filled with the mold cavity filling material (e.g., a second material) 602, creating an intelligent dental device 600 that is covered by the mold section 400. The mold cavity filling material (e.g., the second material) 602 can be, for example, a hard acrylic material.

In 7 is the intelligent dental device 600 made of 6 with its outer occlusal surface 612. The outer occlusal surface 612 in 7 corresponds to the inner surface contour 412 of the mold section 400 from 6 .

In connection with the apron section 200 from 2 , the mold section 400 from 4 , the filled mold cavity made of 6 and the intelligent dental device 600 from 7 The manufacturing process (e.g., using methods 100, 300, and 500) can be described as follows. Apron section 200 can be manufactured (e.g., additively) (also: 3D-printed) and post-processed.

Electronic components (e.g., 630-1; 630-2; 630-3), e.g., with at least one sensor, can be used and/or mounted, in particular, on the mounting surface sections 216, which may have (e.g., pre-printed) recesses, indentations, and/or pockets. A support structure and/or connecting elements may be used.

The mold section 400 can be manufactured independently of the (e.g., additive) manufacturing (also: 3D printing) of the skirt section 200. For example, the mold section 400 can be printed starting from the mold-side sealing structure 418 and the inner surface contour 412.

The mold section 400 can, as in 6 The electronic components 630-1, 630-2, and 630-3 are mounted on the skirt section 200, with their respective sealing structures 218 and 418 interlocking to seal. The tightness of the interlocking seal can be improved by applying pressure to the molded section 400.

The filling material (e.g., the second material) 602 can then be injected through the central fluid sprue (also referred to as injection ports and/or outlets) 416 into 6 can be introduced through the laterally oriented fluid gate channels 416 in 6 Air may escape during the filling of the mold cavity with the mold cavity filling material 602. A bonding agent may be applied to the apron-side boundary 220 of the mold cavity before filling it with the mold cavity filling material. Alternatively or additionally, a mold release agent may be applied to the inner surface contour 412 of the mold section 400 before the mold cavity is filled with the mold cavity filling material. This may improve the bond between the first and second materials of the intelligent dental device 600. Alternatively or additionally, this may ensure that the first and second materials of the intelligent dental device 600 remain bonded when the mold section 400 is removed after the mold cavity has been filled with the mold cavity filling material (and/or the second material) 602.

When the molding material 602 is poured, a positive fit (and/or a form fit) can be achieved. The temperature during pouring (e.g., the temperature of the second material) can be regulated to prevent bubble formation and damage to the electronic components.

When removing the mold section 400 after filling the mold cavity with the mold cavity filling material (and/or the second material) 602 to achieve the intelligent dental device 600, as described in 7 As shown schematically, a burr (also called a bridge) may remain at the transition between the first and second materials. This burr (also called a bridge) can be removed and/or the individually adapted intelligent dental device 600 can be fine-tuned, for example by material removal (e.g., manually and/or with a dental burr).

A relatively soft first material can allow for easy adaptation and/or a comfortable fit of the smart dental appliance to the topology of the person's tooth surface over a longer period of time (e.g., one night).

The first and second materials are advantageously chosen to bond well with each other physically and/or chemically. Alternatively or additionally, bubbles are avoided during the manufacturing process of the intelligent dental device, for example, by appropriately selecting the first and second materials.

Examples of biocompatible materials that can be used as a first material and/or as a second material are listed below in Table 1 along with their known physical properties such as modulus of elasticity (E-modulus), Shore hardness and tensile strength. Table 1: Examples of biocompatible materials and their physical properties Trade name E-module Shore hardness Tensile strength Idodentine Fresh-Colors disc 2300 MPa 120 MPa Yamahachi PMMA disc 3146 MPa 90 MPa Erkodent Erkodur foil 2200 MPa 53 MPa Erkodent Erkoflex (could be considered semi-rigid), foil 92A 31 MPa Erkodent Erkolign (semi-hard), foil 1000 MPa Erkodent Erkoloc (double layer), foil; hard side 2200 MPa 53 MPa Erkodent Erkoloc pro (double layer), film; soft side 27 MPa 39 MPa TrueDent, plastic 2300 MPa 85 MPa KeyTray, plastic 2056 MPa 85 MPa Keysplint Soft, plastic 1100-1400 MPa 44 MPa Keysplint Hard, plastic 2300 MPa 60 MPa Formlabs elastic 50 (soft), plastic 55A 3.4 MPa Formlabs elastic 80A (soft), plastic 80A 8.9 MPa Formlabs dental LT comfort (semi-rigid), plastic 643 MPa 21 MPa Formlabs dental LT comfort (semi-rigid), plastic 2900 MPa 73 MPa

A customized vacuum casting process can be used in the production of the skirt section, the mold section, and/or when filling the mold cavity. In particular, filling the mold cavity can be done using a vacuum casting process. The customization can relate to the shape of the mold cavity.

Each electronic component can be attached using a pouch and/or a bag.

The first material used for the apron section and the mold cavity filling material (and/or the second material) can be selected according to their compatibility, e.g. with regard to expansion (e.g. with temperature changes) and/or for bonding.

In one embodiment, the smart dental device can cover essentially the entire dental arch. In this case, an electronic connection may need to be extended along the incisal area. In another embodiment, the smart dental device can cover only a buccal portion (e.g., only on one side or on both sides). In each embodiment, an extended electronic component (e.g., a microprocessor, an energy storage device, and/or a sensor) can be located in the buccal area, on the facial surface, and/or on the occlusal surface.

When filling the mold cavity with the mold cavity filling material, the electronic components (e.g., placed in a bag or pouch) can be sealed fluid-tight (especially waterproof) in anthology.

The mold cavity filler can be removed and/or fine-tuned after the mold cavity has been filled and the filler has hardened. Alternatively or additionally, any burrs, e.g., due to protrusions in the skirt section used to fix the mold section in the correct position, can be removed.

In one embodiment, an apron section (and/or a first 3D-printed part) is manufactured to fit the upper arch. This can be done with a soft-touch material (e.g., KeySplint Soft) or a hard material (e.g., KeySplint Hard). The soft-touch material on the inside offers the advantage of easy adaptation. The electronic components (e.g., sensors and electronics) are placed on the apron section (and/or on the first 3D-printed part). The sensors can be fixed in place, for example, with a form-fitting adhesive tape. Attaching the electronic components (e.g., the sensors) can be the only manual step in the fabrication of the smart dental device.

The buccal space containing the electronic components can be filled first to ensure correct placement of the components. This can prevent problems with filling the space later on.

A mold section (and/or a second 3D-printed counterpart) can be placed on the skirt section (and/or the first 3D-printed part), with the electronic components attached and optionally secured. The inner surface of the mold section (and/or the second 3D-printed counterpart) is preferably customized. The outer part of the mold section can have a standard format with fixed positions for the fluid connection gate channels (and/or material injection ports).

The mold cavity filling material (and/or the second material) can be selected to bond well with the first material of the apron section (also known as the print). This helps prevent the formation of bubbles when filling the mold.

The intelligent dental appliance (e.g., splint) can be completed by filling the individual upper shape, for example, with a hard acrylic material. A hard, flat surface can be manually adjusted (e.g., by a dentist and/or a dental technician).

8 schematically shows another apron section 200. The apron section 200 from 8 The device features optional projections 216-P (also: spacers) on the mounting surface section 216 (e.g., on the facial side) and projections 218-P (also: supports) on the apron-side sealing structure. The projections 218-P of the apron-side sealing structure can later be removed (also: sacrificed, e.g., ground down), e.g., for fine-tuning the external shape of the individually adapted intelligent dental device.

The optional projections 216-P (also: spacers) of the mounting surface section 216 allow filling with the mold cavity filling material (and/or the second material), in particular a hard material, to enclose the electronic component 630-3 (which, for example, has a printed circuit board). This protects the electronic component 630-3 from mechanical stress and/or damage.

The apron section 200 can be manufactured from a relatively soft material (also known as hard-soft, H/S) (e.g. 3D printed), which allows the inside of the smart dental device to remain flexible.

In 9 A schematic representation of a molded section 400 is shown, which is based on the skirt section 200. 8 is attached. The projections 218-P (also: sacrificial support) of the apron-side sealing structure serve for the precise positioning of the mold section 400 relative to the apron section 200. As schematically shown, the apron section 200 and the mold section 400 together form an individually adapted shape (in particular adapted to a person, e.g., a patient) (e.g., a manufactured, e.g., 3D-printed shape), which can have at least partially standard external dimensions (e.g., as schematically shown by the rectangular outer shape of the mold section 400).

In the schematic example from 9 Three electronic components 630-1; 630-2; 630-3 are shown, which were attached to the skirt section 200 before the mold section 400 was attached.

10 The diagram schematically shows the intelligent dental device 600 after the filling material 602 has hardened and the mold section 400 has been removed. (Example from...) 10 The facial side with the electronic component 630-1 is wider than the lingual side, which in the exemplary embodiment is formed only from the skirt section 200 (and/or the first material).

11 This shows a cross-sectional view of an example of a customized intelligent dental appliance 600. The customized intelligent dental appliance 600 is made of 11 For example, the procedure can yield 500 from 5 be manufactured.

Reference numeral 606 shows an example height of the second material on the occlusal side (e.g., at a position towards the facial side) of the intelligent dental device 600. The height 606 can be manually adjusted, e.g., with a dental bur (e.g., for fine-tuning the height after milling, and in particular to vary the height across the occlusal surface, especially to improve bite comfort with the opposing occlusal tooth surface topology).

Reference numeral 604 shows an exemplary width of the second material that covers the electronic component 630-1 on the facial side of the intelligent dental device 600.

The first material, which forms the apron section 200, and the second material (which in particular forms the occlusal surface of the individually adapted intelligent dental device) can be physically and/or chemically bonded.

In each embodiment, any side (e.g. the occlusal) of the intelligent dental device 600 can be manually adjusted, e.g. with a dental burr.

12 shows a planar cross-sectional view of an exemplary individually adapted intelligent dental device 600 (e.g., the same device 600 as in 11 ). On the upper side of the apron section 200, electronic components (e.g., sensors such as sensor pads) 630-3 are arranged on the occlusal side, wherein electronic components (e.g., a microprocessor, an energy storage unit, an antenna and/or further sensors such as sensor pads) 630-1 are arranged on each buccal facial side, and the electronic components 630-1; 630-3 are connected by electrical connections 630-2 that extend around the labial facial side to both buccal facial sides.

A variable thickness of the second material is shown by reference numeral 604 as an example on the left buccal facial side.

As in 12 As shown schematically, the lingual thickness of the second material can be optimally as thin as possible, particularly close to zero at an incisal (also: labial and/or anterior) section 258 (also: anterior end). The second material 602 is alternatively or additionally selected to be sufficiently thick to protect one of the electronic components, e.g., the electrical connections 630-2 (e.g., along the facial labial and/or facial-buccal sections) and the electronic components 630-1 located on the facial-buccal sides of the buccal section 256 (also: posterior end). The protection includes protection against the ingress of fluid (e.g., water and/or saliva) and/or mechanical damage.

13 Figure 1 shows an exemplary perspective view of a skirt section 200 with attached electronic components 630-1; 630-2; 630-3; 630-4. In particular, the figure shown in Figure 1 contains 13 The example shown includes further electronic components 630-4 on the lingual surface (e.g. one or more sensors, in particular pressure sensors and/or force sensors, and/or circuit components, such as energy storage units and/or microprocessors).

In one embodiment, the perspective view of 13 an apron section 200 that extends 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 13 only a part of the apron section 200, which extends only from the buccal section 256 to the incisal section 258, with another part of the apron section 200 extending along the opposite facial side of the person.

Each of the electronic components (e.g. sensors and/or circuit components) 630-1; 630-2; 630-3; 630-4 can be flexible and/or rigid (e.g. independent of the respective component).

In 13 The electronic component 630-1 is positioned and/or fixed by way of example with an adhesive (e.g. adhesive tape) 632.

The exemplary mounting surface section 216 may have a recess, a projection, a notch or other positioning aid for guiding the electronic component (e.g. 630-1).

14 Figure 1 shows an example of an ensemble of electronic components 630-1; 630-2; 630-3; 630-4. In the example, the facial-side electronic component 630-1 (which includes, for example, the energy storage device and the microprocessor) is connected via electrical connections 630-2 to the electronic components 630-3 and 630-4 on the occlusal and lingual sides, respectively.

The electrical connections (also: conductors) 630-2 in the example from 14 They are designed in a meandering shape so that they can extend between the electronic components (also: substrates) 630-1; 630-3; 630-4. In this way, it is possible to use a standard assembly and adapt its positioning to the size and shape of the individually customized intelligent dental device.

14 Figure 630-1 shows an example of an ensemble of electronic components 630-1, 630-2, 630-3, and 630-4 that can be installed on one side (e.g., the facial side) of the person's mouth. Additional electronic components (not shown) can be connected to the other side (e.g., the facial side) of the person's mouth.

Each of the electronic components (also: substrates) 630-1; 630-3; 630-4 can be formed as a pad, e.g. as a sensor pad.

15A shows a simplified perspective view of an apron section 200, where 15B and 15C Shown in a cross-sectional view from above are different types of support structures for the additive manufacturing of the apron section 200.

In 15B A support structure 240 (e.g., fusible and/or dissolvable, also referred to as a sacrificial support) is provided on the inside of the inner surface contour 212 of the skirt section 200. The support structure 240 (e.g., with a support structure material different from the first and second materials) can be provided before the skirt section 200 is manufactured using the first material.

The use of the support structure 240 can be described as the use of a reversed printing direction. The support structure 240 can initially be created as a support from the inner surface contour 212 of the skirt section 200. The support structure 240 can be sacrificed after printing the skirt section 200, e.g., by melting and/or dissolving. The wall thickness of the skirt section 200 can be produced locally and may (at least in some cases) require additional support (e.g., due to the curved shape of the skirt section 200).

The printing direction (and/or the direction of additive manufacturing) of a multi-material print (and/or additive manufacturing) in 15B can run from bottom to top.

In 15C A support structure 242 is provided on the outer surface contour 214 of the skirt section 200. The support structure 242 can be additively manufactured together with the skirt section 200, e.g. also using the first material.

The printing direction (and/or additive manufacturing direction) according to 15C can run from top to bottom.

Particularly in sections of the skirt section 200 where the first material (e.g. critically) is designed to be thin, suitable support may be required, e.g. with a higher density of support structures 242.

16 This shows another exemplary cross-sectional view of an intelligent dental device 600, which is positioned over the tooth topology (also referred to as: tooth) of a person. The intelligent dental device 600 in 16 The electronic unit 630-1 features an electronic component on the facial side. The electronic unit 630-1 includes an energy storage unit 630-1A (and/or an energy magnet and/or an optical energy storage device), a microprocessor 630-1B, and an antenna 630-1C (e.g., an antenna with communication IC and chip integration).

Reference numeral 260 shows an undercut area with an opening angle (e.g.). In the undercut area 260, the topology of the person's tooth surface is reduced. This can pose a problem if the smart dental appliance 600 (e.g., its apron section) is designed to extend very deeply, as the reduced width hinders the insertion and removal of the smart dental appliance 600.

The intelligent dental appliance (e.g., splint) 600 can have a hard outer surface (e.g., facing the opposite occlusal surface topology) made of a second material for durability. This hard outer surface can optionally be adjusted manually and/or by a dentist (and/or dental technician) to optimize occlusion.

Optionally, the advantages of a hard-soft appliance can be combined with those of a hard acrylic dental appliance (e.g., a splint). The intelligent dental appliance (e.g., splint) 600 can have a soft inner surface (e.g., the first material can be soft), particularly for reasons of comfort and ease of adjustment. Alternatively or additionally, the intelligent dental appliance (e.g., the splint) 600 can have a resistant outer surface (e.g., the second material can be resistant) that can be customized by the dentist (and/or a dental technician) and can serve, for example, as an occlusal stabilization splint. For instance, the first material can be a thermoflex or thermoplastic material that softens at warm water temperatures around 50°C.

The intelligent dental appliance (e.g., splint) 600 can be designed for good retention, e.g., due to the possibility of having small undercuts 260, as exemplified in 16 depicted.

The smart dental device (e.g., the splint) can be activated to communicate with an external device (e.g., a base station, a smartphone, and/or a PC). The external device can, for example, belong to (and/or be intended for use by) the person for whom the smart dental device is being custom-fitted. Alternatively or additionally, the external device can belong to (and/or be intended for use by) the treating physician (e.g., dentist, sleep specialist, and/or neurologist).

Optionally, the intelligent dental device (especially its energy storage) can be charged wirelessly.

The intelligent dental device (e.g., the splint) may have one or more electronic components (and/or sensors) along the buccal, lingual, occlusal, incisal, and/or labial sides.

The first material and the second material can be chosen to provide sufficient protection against the penetration of fluid (e.g. water and/or saliva) for at least four weeks, preferably at least two years and even better for more than five years.

In some embodiments, at least one of the (e.g. embedded) electronic components can be designed to detect the ingress of fluid (e.g. water and/or saliva).

The one or more sensors may include (e.g., one or more) pressure sensors, force sensors, temperature sensors, motion sensors, biosensors, sound sensors, ultrasonic sensors, oxygen saturation sensors, optical sensors, pH and/or ion sensors, humidity sensors, ECG sensors, respiratory sensors, cameras, heart rate sensors, blood pressure sensors, EEG sensors and/or IR sensors.

17 Figure 662 shows an exemplary contour line or undercut line (and/or undercut area) that marks an area for which the smart dental device must be designed. For example, for good retention, the lower boundary of the smart dental device is ideally located slightly below the undercut line 662. The undercut line 662 and/or the lower boundary of the smart dental device defines a (e.g., minimum or maximum) extent of a vertical space 664 for placing the electronic components 630-1; 630-4.

18 shows an example of a non-intelligent rail additively manufactured using support structures 242' on the outer surface, in accordance with the state of the art.

19 shows an example of another additively manufactured non-intelligent rail according to the prior art, in which an outer shape of the additive manufacturing is defined as a circle and the additively manufactured rail is held by bridges 242' as support structures.

In both examples of the state of the art ( 18 and 19 ) no electronic components and no manufacturing using two materials (especially a first and a second) are provided.

The production of the individually adapted intelligent dental device can be largely automated (e.g., down to the manual finishing of the occlusal surface), e.g., using CAD/CAM.

The manufacturing process allows for the creation of a customized intelligent dental appliance (e.g., a splint) made of two materials (e.g., the first and the second) that utilize the advantageous properties of being hard-soft on the tooth side for comfort and easy adjustment, and hard and flat on the occlusal side for long-lasting durability and free adaptation by the dentist (and/or a dental technician).

Advantageously, two perfectly bondable materials can be selected as the first and second materials.

The individually adapted dental appliance (e.g. splint) can have a hard, grindable (and/or adjustable) outer surface and a soft and/or hard-soft inner surface.

A custom-made intelligent dental device (e.g., a splint) can be manufactured using overmolding to seal electronic components (e.g., sensors) and to close the custom-made intelligent dental device (e.g., the splint).

The design of the intelligent dental appliance can, for example, include a digital apron section dataset for use in the fabrication of the apron section. Alternatively or additionally, the facial, lingual, and/or occlusal tooth surface topology of the mandible (also: lower jaw) and/or the maxilla (also: upper jaw) and/or the patient's occlusion can be determined using an intraoral (IO) scan. For example, a CAD design can be created based on the IO scan to determine the shape and size of the apron section (e.g., including the positions of one or more attachment surface sections) and the forming section, as well as optionally a (e.g., final) shape of the intelligent dental appliance after fine-tuning (and/or milling). Alternatively or additionally, the positioning of support structures (e.g., relative to a tooth contact surface section and/or an attachment surface section) can be determined by the (e.g., CAD) design. Alternatively or additionally, the (e.g. CAD) design can be used to achieve optimal positioning of the molded section relative to the skirt section (e.g. by including locating marks or dowel pins in the design).

Fine-tuning may involve trimming the shape and/or polishing the individually adapted intelligent dental device.

A shape (e.g., having the apron section and an outer shape contour) can be manufactured (especially additively) (and/or 3D printed) and have a correspondence to the tooth surface topology of the person (and/or a tooth contact side that corresponds to the upper or lower dental arch of a person or at least a section thereof).

The mold (with, for example, the apron section and the outer mold contour) can also have a second side opposite the tooth contact side. The second side can form at least part of a wall of a mold cavity (also: fillable cavity).

Optionally, the mold can include alignment features (e.g., one or more locating marks and/or dowel pins) to register the position of the molded workpiece (and/or the molded part) in subsequent machines (e.g., a milling device) during the manufacturing process.

Optionally, the mold has one or more mounting surfaces (e.g. recesses and/or cavities) on the inner surface of the mold cavity (also: fillable cavity) that correspond to the locations where at least one electronic component (also: electronic device) can be attached.

The at least one electronic component (also: electronic device; e.g. one or more sensors) can be arranged on the outer surface contour of the skirt section (also: surface of sections of the second side) within the mold cavity (also: fillable cavity of the mold).

The mold cavity (also: fillable cavity of the mold) can be filled with a second (e.g., hard, millable) material.

After hardening, the second material (e.g., hardened, millable) can be milled into the mold cavity to conform to the (e.g., desired) external geometry of the intelligent dental device, in particular to match the opposing tooth surface topology of the person.

The invention relates to an intelligent dental device (e.g., an intelligent intraoral splint) with embedded electronic components (in particular, individually adapted) and a method for manufacturing the intelligent dental device (in particular, individually adapted).

An apron section (and/or a first 3D-printed part) is manufactured to fit the upper or lower jaw arch (or at least a section thereof). The apron section (and/or the first 3D-printed part) can be made from a relatively soft and/or H/S material (e.g., Key-splint Soft) or from a hard material (e.g., Key-splint Hard).

The electronic components (e.g. sensors and/or other electronics) can be placed on the skirt section (and/or on the first 3D-printed part).

Preferably, at least some of the electronic components (e.g., sensors) can be mounted in a shaped cavity of the apron section (and/or the first 3D-printed part). Mounting can be achieved using any suitable means, such as adhesive and/or tape.

The buccal space (e.g., with the mounting surface sections and/or pockets) containing the electronic components can be filled first to ensure the placement of the electronic components.

A mold section (and/or a corresponding second 3D-printed part) can be designed to fit snugly on top of the skirt section (and/or the first 3D-printed part), particularly after the electronic components have been attached and optionally after at least partially filling some of the mounting surface sections and/or pockets for the electronic components. The inner surface of the mold section (and/or its counterpart) can be customized. The outer surface of the mold section can have a standard format with fixed positions for the fluid connection sprue (and/or material injection ports).

The individually adapted intelligent dental device (e.g. a splint) can be completed by filling the individually adapted mold cavity (also: upper mold), e.g. with a hard acrylic material.

A CAD/CAM process can enable the integration of electronic components (e.g., sensors and electronics), with the sensors being located particularly at the occlusion. Two (e.g., additively manufactured and/or 3D-printed) parts, the apron section and the mold section, can be combined. An apron section, as the first part along the tooth-contact side of the smart dental device (e.g., splint), and a mold section, as the second part, can be used to form the shape and/or enclose the mold cavity.

Although the present invention has been described with respect to non-limiting embodiments, it is understood that the invention is not limited to the disclosed embodiments. It is apparent to those skilled in the art that the disclosed invention is intended to cover various modifications and equivalent arrangements included in the appended claims. Therefore, the present invention should not be limited to any one of the described embodiments. Individual embodiments or their individual aspects and features, as described with respect to the drawings, may be combined or interchanged without limiting or extending the scope of the described invention whenever such combination or interchange is meaningful and in line with the present invention.

Reference symbol list

100

Method for manufacturing an apron section of a custom-made dental appliance

S102

Step of loading an apron section digital data set

S103

Step of providing a support structure

S104

Step in the control of an additive manufacturing device for the additive manufacturing of an apron section

S105

Step of removing the support structure

200

Apron section (especially additively manufactured from primary material)

212

Interior surface contour

214

outer surface contour

216

Mounting area section for an electronic component

216-P

Projection of the mounting surface section

218

Skirt-side sealing structure

218-P

Projection of the skirt-side sealing structure

220

Skirt-side boundary of the mold cavity

240

Fusible support structure

242;

Additively manufactured support structure

242' 256

Buccal section of the intelligent dental appliance and/or apron section

258

Labial/incisal section of the intelligent dental appliance and/or apron section

260

Undercutting area with opening angle

300

Method for producing a mold section for manufacturing a customized intelligent dental device

S302

Step of loading a form section digital data set

S304

Step in the control of an additive manufacturing device for the additive manufacturing of a mold section

400

Form section

412

Interior surface contour

414

outer surface contour

416

Fluid connection gate

418

Molded sealing structure

500

Method for manufacturing a customized intelligent dental device

S502

Step of attaching an electronic component

S504

Step of attaching the molded section to the apron section

S506

Step of filling the mold cavity

S507

Step of hardening the filler material

S508

Step of removing the mold section

600

Intelligent dental device

602

Mold cavity filling material (e.g., 2nd material)

604

Width of the mold cavity filling material at the facial surface

606

Height of the mold cavity filling material at the occlusal surface

612

Outer occlusal surface of the intelligent dental device

630-1

230-1 Electronic component(s) on facial surface (e.g. microprocessor, energy storage unit, sensor and/or antenna)

630-2

Electronic component, in particular electrical connection

630-3

Electronic component on occlusal surface (e.g. sensor, especially pressure sensor and/or force sensor)

630-4

Electronic component on occlusal surface (e.g. sensor, especially pressure sensor and/or force sensor)

632

Adhesive (e.g., tape)

662

Undercut line along the topology of the person's tooth surface

664

Available vertical space for electronic components

Claims (35)

Apron section digital dataset for use in the manufacture of an apron section of a custom-fitted smart dental device, wherein the apron section closely fits at least one facial, lingual, and/or occlusal tooth surface topology of an individual, and wherein the apron section digital dataset defines: an inner surface contour of the apron section that is custom-fitted to match the facial, lingual, and/or occlusal tooth surface topology, the inner surface contour defining an occlusal surface, a facial surface, and a lingual surface, the inner surface contour being designed to form an inner surface of the apron section; and an outer surface contour of the apron section, the outer contour defining one or more attachment surface sections for attaching at least one electronic component; wherein the outer surface contour of the apron section defines at least one apron-side sealing structure which is designed to interlock sealingly with a mold-side sealing structure of a mold section, and wherein the apron-side sealing structure defines a boundary line of a mold cavity which is defined by at least a part of the outer surface contour of the apron section as a section of the inner mold cavity contour. Apron section digital data set according to Claim 1 , wherein the apron section and/or the at least one apron-side sealing structure is defined such that it is located at least along one molar area of the outer surface contour and optionally along both molar areas of the outer surface contour. Apron section digital data set according to Claim 1 or 2 , wherein the at least one apron-side sealing structure defines at least one projection and/or recess which is designed to engage sealingly with at least one corresponding recess and/or projection of the form-side sealing structure, wherein the at least one apron-side projection and/or recess is optionally arranged on a facial and/or lingual surface section of the outer surface contour. Apron section digital data set according to one of the Claims 1 until 3 , which further defines at least one apron-side retention structure designed for mutual interlocking with a mold-side engagement structure of a mold section, thereby enabling a sealing engagement of the apron-side sealing structure and the mold-side sealing structure of the mold section when the apron-side retention structure and the mold-side engagement structure are arranged in mutually interlocking engagement. Apron section digital data set according to one of the Claims 1 until 3 , which also defines at least one passport mark. Apron section digital data set according to one of the Claims 1 until 5 , furthermore defining at least one support structure that facilitates the additive manufacturing of the apron section, wherein the at least one support structure is arranged in particular along an occlusal, facial and/or lingual surface section of the outer surface contour of the apron section. Apron section digital data set according to one of the Claims 1 until 6 , wherein the one or more attachment surface sections define one or more protrusions, one or more depressions and/or one or more cavities and/or wherein the one or more attachment surface sections are defined such that they are located on the facial surface and/or in a molar region. Apron section digital data set according to one of the Claims 1 until 7 , wherein one or more mounting surface sections define a meandering path for the mounting of at least one electrical conductor. Apron section digital data set according to one of the Claims 1 until 8 , wherein the outer surface contour of the apron section is defined such that it has a predefined surface roughness and/or predefined surface features, such as protrusions and/or recesses, in order to engage with a filler material and/or to be mutually interlocked with it. Apron section digital data set according to one of the Claims 1 until 9 , wherein the person's tooth surface topology is selected from the group consisting of: - a maxillary tooth surface topology and - a mandibular tooth surface topology. Apron section (200) that is individually adapted to match a person's facial, lingual, and/or occlusal tooth surface topology, wherein the apron section (200) comprises: an inner surface contour of the apron section that is individually adapted to match the person's facial, lingual, and/or occlusal tooth surface topology, wherein the inner surface contour comprises a surface facing an occlusal tooth surface, a surface facing a facial tooth surface, and a surface facing a lingual tooth surface, the inner surface contour forming an inner surface of the apron section; and an outer surface contour of the apron section, wherein the outer contour comprises one or more attachment surface sections for attaching at least one electronic component; wherein the outer surface contour of the apron section has at least one apron-side sealing structure which is designed to engage sealingly with a mold-side sealing structure of a mold section, and wherein the apron-side sealing structure has a boundary line of a mold cavity which is formed by at least a part of the outer surface contour of the apron section as a section of the inner mold cavity contour. Method (100) for producing an apron section that is so individually adapted to match a person's facial, lingual and/or occlusal tooth surface topology, according to Claim 11 , comprising the step of controlling a manufacturing device for manufacturing (S104) the skirt section (200) using a first material. Procedure (100) according to Claim 12 , wherein the first material is a hard material or a soft material and/or wherein the first material is optionally hard at room temperature, medium-hard at 37°C and medium-soft at a hot water temperature of 45°C to 55°C. Procedure (100) according to Claim 12 , which further includes the step: Loading (S102) a skirt section digital data set according to one of the Claims 1 until 10 into a storage area of the manufacturing device. Procedure (100) according to one of the Claims 12 or 14 , wherein the manufacturing step (S104) of the skirt section comprises additive manufacturing (S104), and wherein the additive manufacturing (S014) further comprises the additive manufacturing (S014) of the following: - at least one skirt-side retention structure, - at least one registration mark and/or - a predefined surface roughness and/or predefined surface features. Procedure (100) according to one of the Claims 12 until 15 , wherein the step of manufacturing (S104) the skirt section comprises additive manufacturing (S104), wherein the method (100) further comprises at least one of the following steps: - providing (S103) a support structure for the additive manufacturing (S104) of the skirt section, wherein the support structure is optionally meltable or dissolvable for the additive manufacturing (S104) of the skirt section; and - removing (S105) the support structure of the skirt section additively manufactured (S104) according to the skirt section digital data set, and optionally removing the support structure by milling, grinding, cutting or other subtractive processes. Mold section digital data set for use in the manufacture of an occlusal section of a custom-fitted smart dental appliance that closely matches at least one facial, lingual, and/or occlusal tooth surface topology of an individual, wherein the occlusal section corresponds to at least one opposing occlusal tooth surface topology of the individual, wherein the mold section digital data set defines: an internal surface contour of the mold section, wherein the internal surface contour of the mold section is custom-fitted to correspond at least to the occlusal shape of the opposing dental arch of the individual; an external surface contour of the mold section, wherein the external surface contour of the mold section defines at least one mold-side sealing structure that is designed for a sealing engagement with an apron-side sealing structure of a surface contour of an apron section according to Claim 11 is trained, and/or as by means of an apron section digital data set according to one of the Claims 1 until 10 defined, and wherein the mold-side sealing structure defines a boundary line of the mold cavity, which is defined by at least a part of the inner surface contour of the mold section as a section of the inner mold cavity contour. Mold section digital data set according to Claim 17 , which defines at least one fluid connection gating system extending from the outer surface contour of the mold section to the inner surface contour of the mold section. Mold section digital data set according to Claim 17 or 18 , wherein the outer surface contour of the mold section defines a standardized outer shape, wherein the standardized outer shape is in particular selected from a group consisting of: - a circular shape, preferably with a predetermined radius; and - an arc shape, preferably with a predetermined size and a predetermined shape. Mold section digital data set according to one of the Claims 17 or 19 , wherein the at least one form-side sealing structure defines at least one recess and/or projection which is designed for a sealing engagement with at least one corresponding projection and/or recess of the skirt-side sealing structure, wherein the min at least a recess on the form side and/or the projection is located adjacent to a facial and/or lingual surface section of the inner surface contour. A mold section (400) for manufacturing a customized intelligent dental appliance for a person, wherein the mold section comprises: an inner surface contour of the mold section, wherein the inner surface contour of the mold section is customized to correspond at least to the occlusal shape of the person's opposing dental arch; an outer surface contour of the mold section, wherein the outer surface contour of the mold section comprises at least one mold-side sealing structure designed for a sealing engagement with an apron-side sealing structure of a surface contour of an apron section according to Claim 11 is formed, and wherein the mold-side sealing structure defines a boundary line of the mold cavity, which is defined by at least a part of the inner surface contour of the mold section as a section of the inner mold cavity contour. Method (300) for producing a mold section (400) according to Claim 21 for the manufacture of a customized, intelligent dental device for a person, which includes the step: controlling a manufacturing device for the production (S304) of the mold section using a molding material. Procedure (300) according to Claim 22 , which further includes the step: Loading (S302) a form section digital data set after one of the Claims 17 until 21 into a storage area of the manufacturing device. Procedure (300) according to Claim 23 , wherein the manufacture (S304) of the mold section further comprises the step of producing at least one fluid connection gating system according to the loaded (S302) mold section digital data set. Procedure (300) according to one of the Claims 22 until 24 , wherein the shape-forming material is a hard material. Method (500) for manufacturing a customized intelligent dental device for one person using an apron section (200) according to Claim 11 and a molded section (400) after Claim 21 , comprising the steps of: - attaching (S502) at least one electronic component to one or more attachment surface sections of the outer surface contour of the apron section (200); - attaching (S504) the mold section (400) to the apron section (200) which has the attached (S502) at least one electronic component to define a mold cavity, wherein the attachment (S504) comprises a sealing engagement of the at least one sealing apron-side sealing structure of the apron section (200) with the at least one mold-side sealing structure of the mold section (400); - filling (S506) the mold cavity with a filling material; - curing or allowing the filling material to cure, thereby creating an occlusal section of the intelligent dental device which fluidly embeds the at least one electronic component; and - removal (S508) of the mold section (400). Procedure (500) according to Claim 26 , wherein the filling material is a hard material. Procedure (500) according to Claim 26 or 27 , further comprising at least one of the following steps: - removal of at least one sealing structure of the apron section (200), - removal of at least one retention structure of the apron section, - removal of at least one registration mark, - removal of at least one part of the molded section (400) and/or - removal of at least one part of the occlusal section of the intelligent dental device, wherein the removal is carried out by milling, grinding, cutting and/or other subtractive processes. Procedure (500) according to one of the Claims 26 until 28 , wherein the at least one electronic component comprises an energy storage unit, optionally an electrical energy storage unit, a microprocessor, at least one sensor, optionally an electrical sensor, connections for providing energy from the energy storage unit to at least the microprocessor and the at least one sensor, wherein optionally the energy storage unit is wirelessly rechargeable. Procedure (500) according to one of the Claims 26 until 28 , wherein the at least one electronic component further comprises a communication unit, wherein the communication unit optionally comprises an antenna for wireless transmission of data, wherein the data were preferably acquired by means of the at least one sensor. Procedure (500) according to one of the Claims 26 until 30 , wherein the at least one electronic component further comprises one or more feedback components, wherein the feedback components optionally comprise at least one actuator to provide feedback to the person in response to the processing of the sensor data acquired by means of the at least one sensor. Procedure (500) according to one of the Claims 26 until 31 , wherein the at least one electronic component is attached using an adhesive, in particular an adhesive tape (S106). Intelligent dental device (600), wherein the device (600) is manufactured according to the method (500) according to one of the Claims 26 until 32 is manufactured. A volatile or non-volatile storage medium containing information which, when loaded into a computer's memory, forms a digital record according to one of the Claims 1 until 10 and/or a digital data set of a form section according to Claim 17 until 21 represent. Carrier wave that carries information which, when loaded into a computer's memory, forms a skirt section digital data set according to one of the Claims 1 until 10 and/or a digital data set of a form section according to Claim 17 until 21 represent, whereby the information can be embodied in a packaged form or in a stream.