Occlusal rail arrangement with fixation strap

Description

[0001] The invention relates to an occlusion splint arrangement, in particular for sleep apnea therapy, comprising a maxillary and a mandibular miniplast splint according to the preamble of claim 1.

[0002] Particularly for the treatment of sleep apnea, various designs of occlusal splint arrangements are known from the prior art. These fundamentally aim to influence the position of the upper jaw relative to the lower jaw in such a way that, during deep sleep, the retraction of the lower jaw, tongue muscle, and soft palate is limited to a permissible degree. This is achieved by shifting the lower jaw forward (in the X direction) to stretch the soft palate sufficiently to keep the airways open and reduce or completely eliminate sleep disturbances caused by insufficient air supply.

[0003] A generic occlusal splint arrangement is known from DE 103 41 260 A1. This occlusal splint arrangement comprises a maxillary miniplast splint and a mandibular miniplast splint, which can be placed on the corresponding rows of teeth in the upper and lower jaws, respectively. Furthermore, these miniplast splints have opposing contact surfaces that can be moved relative to each other in a transverse plane, labially in the X-direction and buccally in the Y-direction. To define a specific position of the mandibular miniplast splint relative to the maxillary miniplast splint, the occlusal splint device has an adjustment mechanism with a detent pin and a detent guide. By engaging the detent pin with the detent guide, the position of the mandibular miniplast splint relative to the maxillary miniplast splint is fixed.However, this occlusal splint arrangement has the disadvantage that once the locking pin engages, no relative movement is possible between the two mini-plast splints, which significantly reduces wearing comfort. Further disadvantages of this known occlusal splint arrangement include its complex design and the associated high manufacturing costs. In addition, the occlusal splint device is very susceptible to dirt accumulation in hard-to-clean areas, making it difficult to maintain the necessary hygiene.

[0004] CH 707232 A1 discloses an intraoral snoring therapy device with upper and lower jaw splints for stabilizing the patient's mandible. A fixation strap is guided in a tunnel of the upper jaw splint.

[0005] The object of the present invention is therefore to propose a new occlusal splint arrangement by means of which an assignment between the mandibular and the maxillary miniplast splint is made possible and which avoids the disadvantages of the occlusal splint arrangements known from the prior art.

[0006] This problem is solved by an occlusion rail arrangement according to the teaching of claim 1.

[0007] Advantageous embodiments of the invention are the subject of the dependent claims.

[0008] The occlusal splint arrangement is preferably used for sleep apnea therapy. Although the present embodiment of an occlusal splint arrangement is primarily intended for the treatment of sleep apnea syndrome, it is, in principle, possible to use the occlusal splint arrangement according to the invention for other purposes as well. For example, the occlusal splint arrangement can also be used to treat malocclusions or as an occlusal splint to prevent nocturnal teeth grinding. The occlusal splint arrangement according to the invention is characterized by the positioning means for defining the position of the mandibular miniplast splint relative to the maxillary miniplast splint in the X-direction.The term "definition of position" is to be understood broadly, meaning that it does not define a specific position, but rather a position of the two mini-splints relative to each other that achieves the desired effect. A certain degree of residual mobility for the two rows of teeth in the upper and lower jaws relative to each other significantly increases the feeling of subjective wearing comfort. In the occlusal splint arrangement according to the invention, a fixation band serves as a positioning means, enabling the transmission of tensile forces. The two ends of the fixation band are attached to two fastening elements located in the molar region of the mandibular mini-splint.Simultaneously, a central section of the fixation band, which typically extends from the center of the band towards the ends, can be guided by a guide located in the incisor region of the maxillary miniplast splint. By guiding this central section of the fixation band in the incisor region of the maxillary miniplast splint, compressive forces can be transferred from the central section to the labially oriented outer surface of the maxillary miniplast splint. At the same time, the two ends of the fixation band are attached to the molar region of the mandibular miniplast splint, allowing them to also transmit tensile forces to the two attachment elements on the mandibular miniplast splint. As a result, depending on the length of the fixation band, it is possible to tension the mandibular miniplast splint anteriorly relative to the maxillary miniplast splint.The shorter the fixation band is chosen, the further the mandibular miniplast splint is pulled forward along with the lower jaw relative to the maxillary miniplast splint and the upper jaw.

[0009] One advantage of the occlusal splint arrangement according to the invention is its very simple design, which allows for cost-effective manufacturing. Furthermore, after the miniplast splints are applied, the wearer retains a large range of residual movement between the two halves of the jaw, as only the retraction of the mandible towards the palate is limited by the length of the fixation band. Lateral movements (Y-direction) of the two miniplast splints relative to each other are not rigidly restricted by the fixation band, resulting in a high level of wearing comfort for the wearer.

[0010] The method by which the fastening elements or the guide device are attached to the mandibular or maxillary miniplast splint is, in principle, arbitrary. Since very high demands are placed on the compatibility of the various materials used to manufacture the occlusal splint assembly, it is particularly advantageous if the two fastening elements are integrally molded or embedded into the mandibular miniplast splint and / or the guide device is integrally molded or embedded into the maxillary miniplast splint. By integrally molding the fastening elements or the guide device to their respective miniplast splints, the same material can be used for manufacturing the fastening elements or the inventive device as for manufacturing the two miniplast splints themselves.The one-piece forming or molding also allows for high mechanical stability of the fastening elements or the guide device, which is of great importance with regard to unwanted loosening of the fastening elements or the guide device.

[0011] The material from which the two fastening elements and the guide mechanism are made is generally arbitrary. It is particularly advantageous if the fastening elements are made of the same plastic material as the mandibular miniplast rails, or if the guide mechanism is made of the same plastic material as the maxillary miniplast rail. By using the same plastic for both miniplast rails themselves, as well as for the fastening elements and / or the guide mechanism, compatibility problems arising from the additional placement of the fastening elements and the guide mechanism on the miniplast rails can be easily avoided.

[0012] The manufacturing process used to produce the occlusal splint arrangements according to the invention is, in principle, arbitrary. For example, an impression of the dentition can be made to produce the occlusal splint arrangement, and the two miniplast splints can be pre-molded on the resulting model. However, since the occlusal splint arrangement according to the invention has a very simple structure with the two fastening elements on the mandibular miniplast splint and the guide on the maxillary miniplast splint, it is possible and generally very advantageous for the mandibular miniplast splint, together with the two integrally molded or molded fastening elements, to be produced using a 3D plastic printing process, and / or for the maxillary miniplast splint, together with the integrally molded or molded guide, to be produced using a 3D plastic printing process.By manufacturing the two mini-plast splints using 3D plastic printing, impression errors, which are almost unavoidable when taking an impression, creating a model, and then molding the mini-plast splints on the model, can be virtually eliminated. Instead, both rows of jaws are scanned with appropriate scanners, and the resulting geometric data is used to control the 3D plastic printing process with established CAD / CAM methods. Furthermore, the production of the occlusal splint assembly can be significantly streamlined through the use of 3D plastic printers.

[0013] As an alternative to manufacturing using 3D plastic printing, the occlusion rail arrangement can also be manufactured using CAD-controlled multi-axis milling processes.

[0014] The position of the mandibular miniplast splint relative to the maxillary miniplast splint in the X-direction, as defined by the fixation band, is primarily determined by the length of the fixation band. The shorter the fixation band, the further the mandibular miniplast splint, with the mandible held against it, is pulled forward, thereby tensioning the soft palate. To easily adjust the position of the two miniplast splints relative to each other, it is particularly advantageous if the fixation band is length-adjustable. By lengthening or shortening the fixation band, the position of the two miniplast splints relative to each other can then be individually adjusted to the needs of the respective wearer.Alternatively, several fixing bands of different lengths can be included with the occlusal splint arrangement to allow the user to adjust the relative position of the two miniplast splints to each other by selecting a specific fixing band.

[0015] The material from which the fixation band is made is essentially arbitrary. However, to minimize the risk of compatibility issues when wearing the occlusal splint due to the material of the fixation band, it is particularly advantageous if the fixation band is made of plastic, as biocompatible plastics are readily available.

[0016] For the occlusal splint to have a reproducible and defined effect in sleep apnea therapy, it is crucial that the soft palate maintains a consistent minimum tension. To ensure this at all times, it is particularly advantageous that the fixation band is highly rigid along its longitudinal axis and allows virtually no elastic deformation under the stresses encountered during intended use. This prevents the mandible from being pulled so far relative to the maxilla, even during involuntary movements of the two jaw rows against each other, due to undesirable elasticity of the fixation band, that the soft palate falls below the required tension.

[0017] According to a preferred embodiment, the fixing band is made of a dimensionally stable, elastically deformable plastic. In its unloaded state, the fixing band has an arc-shaped form. As a result, the pre-formed fixing band has a shape that approximately corresponds to the shape it assumes after being fixed to the Miniplast rails. This pre-forming, which corresponds to the installation shape, significantly reduces the material stress in the fixing band, so that the user does not need to deform the fixing band at all, or only minimally, to fix it to the Miniplast rails.

[0018] There are numerous possibilities for the design of the guide mechanism and / or the fastening elements on the maxillary and mandibular miniplast splints. The guide mechanism of a mandibular miniplast splint is designed in the form of a groove. This groove runs labially in the incisal region of the maxillary miniplast splint, i.e., on the outer surface of the splint and parallel to the dental arch. The fixation band can be inserted into this groove of the maxillary miniplast splint from the outside, allowing it to transmit compressive forces to the base of the groove. These compressive forces, transmitted from the central section of the fixation band to the base of the groove, then generate the necessary tensile stress in the fixation band, which pulls the mandibular miniplast splint forward relative to the maxillary miniplast splint and secures its position.

[0019] If, for example, the fixing band is to be positively fixed in the groove of the miniplast rail using an interference fit, it is advantageous if the fixing band is elastically deformable transversely to its longitudinal axis. This elastic deformability of the fixing band allows it to be compressed, at least slightly, transversely to its longitudinal axis and pressed into the groove through a narrowed opening.

[0020] The length of the groove in the maxillary miniplast rail should be sufficient to ensure adequate guidance of the fixation band on the maxillary miniplast rail at all times. Simultaneously, according to a preferred embodiment, there should be a gap between the two ends of the groove in the maxillary miniplast rail and the two fastening elements on the mandibular miniplast rail, within which the fixation band runs unguided with a free section of its length. This free section of the fixation band ensures that displacement of the mandibular miniplast rail relative to the maxillary miniplast rail is permitted, at least in the Y-direction, i.e., transversely to the clamping direction.

[0021] To control the opening angle of the mandible relative to the maxilla using the occlusal splint arrangement, it is advantageous to have a gap between the two lateral ends of the groove in the maxillary miniplast splint and the two attachment elements on the mandibular miniplast splint. The mandibular miniplast splint features a right and a left deflection element, around which the fixation band is deflected, thereby limiting the vertical relative movement between the maxillary and mandibular miniplast splints. As a result, the deflection elements determine the degree to which the mandible is drawn against the maxilla.

[0022] According to a preferred embodiment, one or more constrictions are provided at the opening of the groove, through which the fixing band, which is particularly circular in cross-section, is positively locked in the groove. As a result, the position of the fixing band in the groove can be secured. This is particularly advantageous if the user first places the two unconnected miniplast splints on the upper and lower jaw and only then connects the two miniplast splints by fixing the fixing band in the groove.

[0023] Furthermore, it is particularly advantageous if an insertion ramp is provided on the outward-facing side of the constrictions, through which the fixation band is guided into the groove. This is especially beneficial if the user first applies the two unconnected miniplast splints to the upper and lower jaws and only then connects the two miniplast splints by fixing the fixation band in the groove.

[0024] For the proper functioning of the occlusal splint arrangement according to the invention, particularly in sleep apnea therapy, it is crucial that the fixation band does not unintentionally detach from the groove on the maxillary mini-splint, for example, during sleep, as otherwise the intended fixation of the mandibular mini-splint relative to the maxillary mini-splint is no longer guaranteed. To ensure this securing of the fixation band in the groove, fixing pins and / or fixing rods can be provided at the opening of the groove, narrowing the opening of the groove section by section or along its entire length. When inserting the fixation band into the groove, the user then has the option of, for example, slightly deforming the fixation band elastically and thereby pushing it through the narrowed opening of the groove. Unintentional detachment of the fixation band from the groove opening narrowed by the fixing pins or fixing rods is thus prevented.Where fixing pins are used to secure the fixing strip and the groove, it is particularly advantageous if at least three fixing pins are provided. Adjacent fixing pins are then arranged alternately on the opposite side edges of the groove, with their free ends projecting into the opening in opposite directions. To insert the fixing strip into the groove thus configured with the multiple fixing pins, the initially unstretched fixing strip can be inserted into the groove, whereby the fixing strip is alternately bent upwards and downwards as it passes the adjacent fixing pins.

[0025] As an alternative to using fixing pins, fixing ridges can also be provided at the opening of the groove to secure the fixing band. According to a preferred embodiment, these fixing ridges can extend continuously between the two lateral ends of the groove. The cross-sectional area of ​​the opening between the two fixing ridges should then be at least large enough to allow the fixing band to be inserted into the groove, even with permissible deformation of its cross-section.

[0026] According to a preferred embodiment, the cross-section of the groove is at least slightly smaller than the cross-section of the fixing strip, with the fixing strip being secured in the groove by the resulting press fit. Due to the friction between the groove surface and the fixing strip, the press fit prevents the fixing strip from shifting after it has been pressed into the groove base.

[0027] A press fit can be achieved particularly effectively if the fixing band has a circular cross-section.

[0028] When the mandibular miniplast rail moves relative to the maxillary miniplast rail in the Y-direction, i.e., perpendicular to the clamping direction, the two fastening elements on the mandibular miniplast rail are displaced in the Y-direction relative to the maxillary miniplast rail. To avoid undesirably restricting this movement, it is particularly advantageous if the cross-section of the groove is larger than the cross-section of the fixing band, so that no significant frictional engagement occurs between the fixing band and the groove surface. In this way, the fixing band can then be moved along its longitudinal axis in the groove with virtually no resistance, so that the movement of the mandibular miniplast rail in the Y-direction is not hindered by the frictional fixation of the fixing band in the groove.The clamping effect of the fixing band on the mandibular miniplast splint according to the invention is not negatively affected, since this clamping effect only requires the transmission of compressive forces from the fixing band to the base of the groove. According to a further embodiment, to secure the fixing band in the groove, it is also possible for the fixing band to have a rectangular cross-section, wherein the width of the fixing band is larger than the opening cross-section of the groove, and wherein the height of the fixing band is smaller than the opening cross-section of the groove. When inserting the fixing band into the groove, it is then held so that its narrower, broad side is inserted into the opening cross-section of the groove.Once the fixation band extends over the full length of the groove, it can be rotated 90° so that the band cannot be pulled back through the opening due to its greater width. The position of the fixation band can then be secured by hooking its ends onto the fastening devices of the mandibular miniplast splint.

[0029] Ideally, the fixation band in the incisor region should run with the long side of its rectangular cross-section parallel to the outer surface of the incisors, i.e., parallel to the dental arch. This ensures that the fixation band exhibits the highest stiffness in the direction of greatest transverse stress.

[0030] The design of the two fastening elements on the mandibular mini-splint is essentially arbitrary. A particularly simple and cost-effective solution is to design the fastening elements as fixing pins that project laterally in the molar region of the mandibular mini-splint. The free length of these fixing pins can be very short, as only a relatively small projection is required to secure the ends of the fixation band. Furthermore, such fixing pins can be readily molded in one piece onto the plastic of the mandibular mini-splint, especially using 3D printing. The geometry of the fixing pins should be chosen so that the ends of the fixation band can be securely hooked onto them via a recess or a hook element.

[0031] To prevent the ends of the fixing strap from detaching from the fixing pins, a preferred embodiment provides a locking element at the free end of the fixing pins. This locking element can, for example, be a thickening whose cross-section is larger than the cross-section of a recess at the end of the fixing strap, by which the fixing strap is hooked onto the fixing pin. The material of the fixing strap must then be sufficiently deformable so that the end of the fixing strap, with the recess provided therein, can be pushed onto the fixing pin, overcoming the thickening.

[0032] Preferably, at least one projection is provided at the free end of each fixing pin. In a mounting position of the fixing strap, this projection can be inserted into an opening at the end of the strap. In a fixing position, the projection engages behind the opening at the end of the strap, securing it in place. As a result, the user can easily hook the fixing strap onto the fixing pins by twisting the ends accordingly, even when the strap is not yet connected. In the operating position, the ends of the fixing strap are then in the locking position, reliably preventing the ends from unintentionally detaching from the fixing pins due to the projections' engagement.

[0033] Especially with pre-formed fixing bands, it must be ensured that the fixing band is correctly positioned on the fixing pin according to its pre-formed shape. To guarantee this, the locking element on the right fixing pin can have a different shape than the locking element on the left fixing pin. In particular, the thickening on the right fixing pin can have a different diameter than the thickening on the left fixing pin. The opening at the left end of the fixing band is aligned with the shape of the locking element on the left fixing pin, and the opening at the right end of the fixing band is aligned with the shape of the locking element on the right fixing pin, so that the user can only hook the ends of the fixing band onto the fixing pins in the correct orientation.

[0034] The fastening elements that protrude laterally from the mandibular miniplast splint can cause irritation of the oral mucosa in the cheek area for sensitive users. To counteract this irritation, a preferred embodiment provides smooth cover elements adjacent to the fastening elements on the mandibular miniplast splint. These cover elements extend beyond the splint, corresponding to the fastening elements, and thus at least partially cover them laterally. Due to their smooth surface, these cover elements can significantly reduce or even completely eliminate irritation of the oral mucosa.

[0035] To tailor the occlusal splint arrangement to the individual needs of a patient, it is advantageous if markings are placed on both mini-splints to indicate their relative position. This particularly facilitates the selection of a fixation band of the appropriate length.

[0036] Various embodiments of the invention are shown schematically in the drawings and are explained below by way of example.

[0037] They show: Fig. 1 an occlusal splint arrangement with fixation band for defining the position between mandibular miniplast splint and maxillary miniplast splint in a perspective view from above; Fig. 2 the occlusal splint arrangement according to Fig. 1 in side view; Fig. 3 the mandibular miniplast splint of the occlusal splint arrangement according to Fig. 1in a perspective view from above; Fig. 4 the fastening element of the mandibular miniplast rail according to Fig. 3 in the partial cross-section along section line II; Fig. 5 the fastening element according to Fig. 4 after attaching the end of a fixing tape; Fig. 6 a second embodiment of a fastening element for arrangement on a mini-plastic rail in partial cross-section; Fig. 7 the fastening element according to Fig. 6 after attaching the end of a fixing tape; Fig. 8 the maxillary miniplast splint of the occlusal splint arrangement according to Fig. 2 in the partial cross-section along section line II-II; Fig. 9 a second embodiment of a miniplast rail in partial cross-section; Fig. 10 a third embodiment of a miniplast rail in partial cross-section; Fig. 11 the miniplast rail according to Fig. 10 Front view; Fig. 12a second embodiment of an occlusal splint arrangement in a side view; Fig. 13 a second embodiment of a fastening element of a mandibular miniplast splint with one end of the associated fixing band in a top view; Fig. 14 a third embodiment of the right and left fastening element of a mandibular miniplast splint with the right and left ends of the associated fixing band in a top view; Fig. 15 a pre-formed fixing band viewed from above; Fig. 16 the pre-formed fixing tape according to Fig. 15 in side view; Fig. 17 a fixing band in cross-section, secured by a press fit in a groove; Fig. 18 the fixing tape according to Fig. 17 when inserted into the groove according to Fig. 17 in cross-section; Fig. 19 a third embodiment of an occlusal splint arrangement in a side view; Fig. 20 the maxillary miniplast splint of the occlusal splint arrangement according to Fig. 19in side view; Fig. 21 the mandibular miniplast splint of the occlusal splint arrangement according to Fig. 19 View from above; Fig. 22 the fastening element of the mandibular miniplast rail according to Fig. 21 with attached fixing tape in partial cross-section; Fig. 23 the pre-formed fixing band of the occlusal splint arrangement according to Fig. 19 in a side perspective view; Fig. 24 the pre-formed fixing tape according to Fig. 23 View from above.

[0038] Fig. 1 Figure 1 shows an occlusal splint arrangement 01, such as can be used for sleep apnea therapy. The occlusal splint arrangement 01 comprises a maxillary miniplast splint 02 for placement on the upper dental arch and a mandibular miniplast splint 03 for placement on the lower dental arch. The two miniplast splints 02 and 03 are aligned in a transverse plane 04 (see Figure 1). Fig. 2) labially in the X-direction and buccally in the Y-direction, relatively displaceable against each other.

[0039] To increase tension in the soft palate during sleep apnea therapy, the mandibular miniplast splint 03 must be pulled forward in the X-direction relative to the maxillary miniplast splint 02 and held in that position. A fixation band 05 serves to define the required position between the mandibular miniplast splint 03 and the maxillary miniplast splint 02. The two ends 06 of the fixation band 05 each have ring-shaped recesses 07 and can be hooked onto fastening elements 08 that are integrally molded onto the mandibular miniplast splint 03. Fig. 1Only one end 06 of the fixation band 05 is shown. The second end 06 of the fixation band 05 is attached in the same way to a second fastening element 08 with a recess 07 on the right side of the mandibular miniplast splint 03. Both fastening elements 08 are located in the molar region 09 of the miniplast splint 03 and project buccally from the side surface of the miniplast splint 03.

[0040] The maxillary miniplast splint 02 has a guide element 11 in the incisor region 10, in which a central section 12 of the fixation band 05 is guided. The guide element 11 is designed in the form of a groove 13 (see Fig. 8 ) and extends between its ends 14, of which in Fig. 1 only the left end 14 is shown, through the plastic material of the maxillary miniplast splint 02.

[0041] If the two ends 06 of the fixing band 05 are hooked onto the fastening elements 08 of the mandibular miniplast splint 03 and the middle section 12 of the fixing band 05 runs through the groove 13, then, depending on the length of the fixing band 05, the mandibular miniplast splint 03 can be tensioned forwards in the X-direction relative to the maxillary miniplast splint 02 in order to influence the desired tension of the soft palate.

[0042] Fig. 2Figure 1 shows the occlusal splint assembly 01 with the two miniplast splints 02 and 03 in a side view. The fixing band 05 is made of a plastic that is deformable transversely to its longitudinal axis but highly rigid in the longitudinal direction, so that the fixing band 05 is essentially non-elastic in the direction of tension. This prevents the user from pulling the miniplast splint 03 backwards against the tension direction by applying corresponding muscular forces, thereby elastically deforming the fixing band 05. At the same time, a free longitudinal section 15 is provided between the end 14 of the groove 13 on the one hand and the fastening element on the other, in which the fixing band runs unguided between the two miniplast splints 02 and 03 on the left and right sides of the occlusal splint assembly 01.This free length section 15 of the fixing band 05 allows movement of the two miniplast rails 02 and 03 in the transverse plane perpendicular to the X direction, namely in the Y direction.

[0043] Fig. 3 Figure 1 shows the mandibular miniplast splint 03 with the attachment element 08 attached in the molar region 09 in a perspective view. The attachment element 08 is made of the same plastic as the mandibular miniplast splint 03 itself. The structure of the attachment element 08 is described below with reference to the drawings. Fig. 4 and Fig. 5 explained in more detail.

[0044] Fig. 4Figure 1 shows the fastening element 08 of the mandibular miniplast splint 03 in partial cross-section along section line II. The fastening element 08 is designed in the form of a fixing pin 16 that projects laterally from the miniplast splint 03. The fixing pin 16, and thus the fastening element 08, is integrally molded onto the miniplast splint 03 and is made of the same plastic as the miniplast splint 03. The miniplast splint 03 with the fastening element 08, namely the fixing pin 16, can be manufactured particularly easily and cost-effectively by 3D plastic printing. At the free end of the fixing pin 16 is a locking element 17, which is designed as a thickening of the fixing pin 16.

[0045] Fig. 5Figure 1 shows the fixing pin 16 after the fixing band 05 has been attached by sliding the recess 07 onto the fixing pin 16. Unintentional detachment of the fixing band 05 from the fixing pin 16 is prevented by the locking element 17, which has a larger cross-section than the recess 07.

[0046] Fig. 6 Figure 18 shows an alternative embodiment of a miniplast splint, on which a fixing pin 16 is also integrally molded. In contrast to the miniplast splint 03, a cover element 19 is integrally molded onto the miniplast splint 18 and is located adjacent to the fixing pin 16. The cover element 19 extends beyond the miniplast splint 18 by the same free length as the fixing pin 16 and covers the fixing pin 16 with a smooth side surface 20. This coverage by the cover element 19 prevents irritation of the mucous membrane in the area of ​​the cheeks when wearing the mandibular miniplast splint 18.

[0047] Fig. 7 shows the mandibular miniplast splint 18 with the fixing pin 16 and the cover element 19 after the fixing band 05 has been attached to the fixing pin 16.

[0048] Fig. 8 shows the maxillary miniplast splint 02 in partial cross-section along section line II-II (see Fig. 2The guide element 11 on the miniplast splint 02 is formed by the groove 13, which is integrally molded into the plastic of the maxillary miniplast splint 02. This can be manufactured very simply and cost-effectively by 3D plastic printing. The cross-section of the groove 13 is slightly larger than the cross-section of the fixing band 05, so that the fixing band can be moved along its longitudinal axis in the groove 13 with essentially no resistance, since there is essentially no frictional engagement between the fixing band 05 and the inside of the groove 13. Two fixing ribs 22 and 23 are provided at the opening 21 of the groove 13, which narrow the opening 21 of the groove 13. The remaining opening cross-section of the opening 21 is slightly smaller than the cross-section of the fixing band 05, so that slippage of the fixing band 05 out of the groove 13 during wear of the occlusal splint assembly 01 is prevented.

[0049] Fig. 9Figure 24 shows an alternative embodiment of a maxillary miniplast rail, the guide device of which is again designed in the form of a groove 25. A rectangular fixing band 26 is guided in the groove 25, wherein the width of the fixing band 26 is larger than the opening cross-section of the groove 25, and wherein the height of the fixing band 26 is smaller than the opening cross-section of the groove 25. To insert the fixing band 26, it is positioned opposite the illustration in Figure 24. Fig. 9The fixation band 26 is rotated 90° and threaded into the groove 25 with one side edge. Within the groove 25, the fixation band 26 is then rotated back 90° and, due to its greater width compared to the opening cross-section of the groove 25, cannot slip out of the groove 25 while the maxillary miniplast splint 24 is being worn. Because the fixation band runs with the longitudinal side of its rectangular cross-section parallel to the outer surface of the incisors, i.e., parallel to the dental arch, in the incisor region, it exhibits high stiffness in the main load direction.

[0050] Fig. 10 and Fig. 11 Figure 27 shows a further embodiment 27 of a maxillary miniplast rail, which in turn includes a groove 28 as a guide element 29. To secure the fixing band 26 in the groove 28, the miniplast rail 27 includes integrally molded fixing pins 30, each of which projects into the opening of the groove 28 from one side and changes the cross-sectional area of ​​the opening.

[0051] As from Fig. 11 As can be seen, the various fixing pins 30 are arranged alternately on the upper side edge 31 and the lower side edge 32 of the groove 28, so that the fixing band 26 can be inserted into the groove 28 more easily.

[0052] Fig. 12 Figure 1 shows a second embodiment 33 of an occlusal splint arrangement in a side view. The basic structure of the occlusal splint arrangement 33 with two miniplast splints 34 and 35 corresponds to the structure of the occlusal splint arrangement 01, as shown in Figure 1. Fig. 2 as shown. Unlike the occlusal splint arrangement 01, the occlusal splint arrangement 33 has a deflecting element 36 on the mandibular miniplast splint 35, on which a fixing band 37 can be deflected after being hooked into the groove 38 of the maxillary miniplast splint 34. Fig. 12Only the left deflection element 36 is shown. A corresponding right deflection element is located on the opposite side of the mandibular miniplast splint 35. The two deflection elements 36 provided on the mandibular miniplast splint 35 allow the mandibular miniplast splint 35, and thus the mandible, to be drawn against the maxillary miniplast splint 34, and thus against the maxilla, thereby limiting the opening angle of the mandible relative to the maxilla.

[0053] Fig. 13 Figure 1 shows a second embodiment 39 of a fastening element on a mandibular miniplast splint. The end of the associated fixation band 40 is shown next to the fastening element 39. The fastening element 39 is designed in the form of a fixing pin and is Fig. 13Shown in a top view. Two projections 41 and 42 are formed on the fastening element 39, extending laterally beyond the main body of the fixing pin. An opening 44 is provided at the end 43 of the fixing band 40, the contour of which corresponds to the contour of the fastening element 39 in the area of ​​the projections 41 and 42. By rotating the end 43 by 90°, the fixing pin of the fastening element 39 can be inserted into the opening 44 and then fixed by rotating the end 43 back by 90°. In their fixed position, the projections 41 and 42 engage behind the edge of the opening 44, thus preventing the fixing band 40 from unintentionally detaching from the fastening element 39.

[0054] Fig. 14Figure 1 shows a third embodiment of fastening elements 45 and 46, each designed as a fastening pin. The left fastening element 45 is associated with the left end 47 of a fixing band 48. The right fastening element 46 is associated with the right end 49 of the fixing band 48. The opening 50 at the left end 47 of the fixing band 48 has a smaller cross-section than the opening 51 at the right end 49 of the fixing band 48. Accordingly, the fixing pins on the left fastening element 45 and the right fastening element 46 each have a different diameter, so that the opening 50 can be slid onto the fastening element 45 and the opening 51 onto the fastening element 46, thus allowing the fixing band 48 to be hooked onto the right and left sides.Due to the different diameters of the openings 50 and 51, accidental attachment of the left end 47 to the right fastening element 46 is impossible, as the diameter difference is too great for the left end 47 with its opening 50 to be attached to the right fastening element 46. Therefore, incorrect attachment of the fixing band 48 to the two fastening elements 45 and 46 is also impossible.

[0055] Fig. 15 and Fig. 16 Figure 1 shows an embodiment 52 of a pre-formed fixing band in a top view and a front view. Due to the arcuate pre-formation of the fixing band 52, its shape in the unloaded state corresponds precisely to the arcuate shape that the fixing band 52 assumes when fixed to an occlusal splint arrangement 01. This avoids stress loads caused by deformation of the fixing band 52, as occur with non-pre-formed fixing bands.

[0056] Fig. 17 and Fig. 18 Figure 53 shows a partial cross-section of a maxillary miniplast splint 53 in the area of ​​the groove 54 for the fixed reception of a fixation band 55 with a circular cross-section. The fixation band 55 is made of a plastic material that is elastically deformable transversely to its longitudinal axis. The opening 56 of the groove 54 is designed as a constriction, such that the cross-sectional area of ​​the opening 56 is smaller than the outer diameter of the fixation band 55. If the fixation band 55 is inserted as shown in Figure 54, the opening 56 is formed by a narrowing of the groove 54, such that the cross-sectional area of ​​the opening 56 is smaller than the outer diameter of the fixation band 55. Fig. 18As shown schematically, when the fixing band 55 is pressed from the outside towards the groove 54, a deformation resistance must be overcome, which slightly flattens the fixing band 55 so that it slides into the groove 54. To facilitate this insertion of the fixing band 55 into the groove 54, an insertion ramp 57 is provided on the outwardly facing side of the constricted opening 56. As soon as the fixing band 55 is completely received in the groove 54, a positive-locking press fit is formed, so that the fixing band 55 can only be moved relative to the groove 54 by overcoming a corresponding frictional resistance.

[0057] Fig. 19 Figure 58 shows a third embodiment of an occlusal splint arrangement in a side view. The basic structure of the occlusal splint arrangement 58 with two miniplast splints 59 and 60 corresponds to the structure of the occlusal splint arrangement 01, as shown in Figure 1. Fig. 2 is shown.

[0058] In the occlusal splint arrangement 58, a fixing band 61 is provided to connect the maxillary miniplast splint 59 and the mandibular miniplast splint 60. This band can be fixed in a groove 62 of the maxillary miniplast splint 59. The ends of the fixing band 61 are attached to fastening elements 63 and 64. The fastening elements 63 and 64 are integrally molded from plastic onto the mandibular miniplast splint 60 and can be manufactured from plastic using 3D printing.

[0059] Fig. 20 shows the maxillary miniplast rail 59 of the occlusal rail arrangement 58 with the groove 62 in a side view.

[0060] Fig. 21 shows the mandibular miniplast splint 60 with the fastening elements 63 and 64 in a top view.

[0061] Fig. 22 shows the fastening element 63 of the mandibular miniplast splint with the fixing band 61 attached to it in partial cross-section.

[0062] Fig. 23Figure 1 shows the pre-formed fixing band 61 of the occlusion rail arrangement 58 with the openings 65 and 66 for hanging on the fastening elements 63 and 64 in a side perspective view.

[0063] Fig. 24 Figure 58 shows the pre-formed fixing band 58 with the openings 65 and 66 for hanging on the fastening elements 63 and 64 in a top view. Reference symbol list 01 Occlusion rail arrangement 39 Fastener 02 Maxillary Miniplast splint 40 Fixing tape 03 Mandibular miniplast splint 41 Overhang 04 Transverse plane 42 Overhang 05 Fixing tape 43 End (fixation tape) 06 End (fixation tape) 44 Opening (fixing tape) 07 Cutout (fixing tape) 45 Left fastening element 08 Fastener 46 Right fastening element 09 molar area 47 Left end (fixing tape) 10 Incisor area 48 Fixing tape 11 Management system 49 Right end (fixing tape) 12 Middle section (fixation tape) 50 Opening (fixing tape) 13 Nut 51 Opening (fixing tape) 14 End (groove) 52 Pre-shaped fixing tape 15 Free length section (fixing strap) 53 Maxillary Miniplast splint 16 fixing pin 54 Nut 17 Safety element 55 Fixing tape 18 Mandibular miniplast splint 56 Opening with narrowing 19 Cover element 57 Lead-in chamfer 20 Smooth side surface (cover element) 58 Occlusion rail arrangement 21 Opening (groove) 59 Maxillary Miniplast splint 22 Fixing bridge 60 Mandibular miniplast splint 23 Fixing bridge 61 Fixing tape 24 Maxillary Miniplast splint 62 Nut 25 Nut 63 Fastener 26 Fixing tape 64 Fastener 27 Maxillary Miniplast splint 65 opening 28 Nut 66 opening 29 Fixing device 30 fixing pin 31 Upper side edge (groove) 32 Lower side edge (groove) 33 Occlusion rail arrangement 34 Maxillary Miniplast splint 35 Mandibular miniplast splint 36 deflection element 37 Fixing tape 38 Nut

Claims

1. An occlusal splint arrangement (01, 33,58), in particular for sleep apnoea therapy, having a maxillary miniplast splint (02, 24, 27, 34, 53, 59) to be disposed on the maxillary row of teeth and a mandibular miniplast splint (03, 18, 35, 60) to be disposed on the mandibular row of teeth, the mandibular miniplast splint (03, 18, 35, 60) being brought into contact with the maxillary miniplast splint (02, 24, 27, 34, 53, 59) in a transverse plane (04), and the mandibular miniplast splint (03, 18, 35, 60) being displaced labially in the x-direction and buccally in the y-direction in the transverse plane (04) with respect to the maxillary miniplast splint (02, 24, 27, 34, 53, 59), and the occlusal splint arrangement (01, 33, 58) comprising a positioning means by means of which the position of the mandibular miniplast splint (03, 18, 35, 60) with respect to the maxillary miniplast splint (02, 24, 27, 34, 53, 59) is defined in the x-direction, wherein the positioning means is designed like a fixing band (05, 26, 37, 40, 48, 52, 55, 61) transmitting tensile forces, the two ends (06, 43, 47, 49) of the fixing band (05, 26, 37, 40, 48, 52, 55, 61) being fixed to two fastening elements (08, 39, 45, 46, 63, 64), and the fastening elements (08, 39, 45, 46, 63, 64) being disposed in the left and the right molar region (09) of the mandibular miniplast splint (03, 18, 35, 60), and wherein a middle section (12) of the fixing band (05, 26, 37, 40, 48, 52, 55) being guided at a guide means (11, 29), and the guide means (11, 29) being disposed in the incisor region (10) of the maxillary miniplast splint (02, 24, 27, 34, 53, 59), characterized in that the guide means (11, 29) at the maxillary miniplast splint (02, 24, 27, 34, 53, 59) is designed like a groove (13, 25, 28, 38, 54, 62) which is disposed labially in the incisor region (10) of the maxillary miniplast splint (02, 24, 27, 34, 53, 59), the groove (13, 25, 28, 38, 54, 62) at least partially accommodating the fixing band (05, 26, 37, 40, 48, 52, 55, 61),2. The occlusal splint arrangement according to claim 1, characterised in that the two fastening elements (08) are integrally moulded on or into the mandibular miniplast splint (03) and / or in that the guide means (11, 29) is integrally moulded on or into the maxillary miniplast splint (02, 24, 27).

3. The occlusal splint arrangement according to claim 2, characterised in that the two fastening elements (08) are made of the same plastic material as the mandibular miniplast splint (03) and / or in that the guide means (11, 29) is made of the same plastic material as the maxillary miniplast splint (02, 24, 27).

4. The occlusal splint arrangement according to claim 3, characterised in that the mandibular miniplast splint (03), together with the two fastening elements (08) integrally moulded thereon or thereinto, is produced in a 3D plastic printing process and / or in that the maxillary miniplast splint (02, 24, 27), together with the guide means (11, 29) integrally moulded thereon or thereinto, is produced in a 3D plastic printing process or in that the mandibular miniplast splint (03), together with the two fastening elements (08) integrally moulded thereon or thereinto, is produced in a multi-axis milling process and / or in that the maxillary miniplast splint (02, 24, 27), together with the guide means (11, 29) integrally moulded thereon or thereinto, is produced in a multi-axis milling process.

5. The occlusal splint arrangement according to any one of claims 1 to 4, characterised in that the fixing band (05, 26, 37, 40, 48, 52, 55, 61) is adjustable in length, in that the fixing band (05, 26, 55) is made of a plastic material, in that the fixing band (05, 26) is designed highly rigid in the direction of its longitudinal axis, and / or in that the fixing band (55) is designed elastically deformable transversely to its longitudinal axis.

6. The occlusal splint arrangement according to any one of claim 1 to 5, characterised in that between each one of the two lateral ends (14) of the groove (13, 25, 28) in the maxillary miniplast splint (02, 24, 27) and the respective one of the two fastening elements (08) at the mandibular miniplast splint (03) a distance is present, in which the fixing band (05, 26) runs unguided with a free length section (15), the two free length sections (15) of the fixing band allowing a displacement of the mandibular miniplast splint (03) with respect to the maxillary miniplast splint (02, 24, 27) at least in the y-direction, and / or in that between each one of the two lateral ends of the groove (38) in the maxillary miniplast splint (34) and the respective one of the two fastening elements at the mandibular miniplast splint (35) a distance is present, a right and a left deflection element (36) being provided at the mandibular miniplast splint (35), at which (36) the fixing band (37) is deflected and by which the vertical relative movement between the maxillary miniplast splint (34) and the mandibular miniplast splint (35) is limited.

7. The occlusal splint arrangement according to any one of claims 1 to 6, characterised in that one or more constrictions are provided at the opening (56) of the groove (54), by means of which the fixing band (55), which is in particular circular in the cross section, is fixed in a positive locking manner in the groove (54).

8. The occlusal splint arrangement according to claim 7, characterised in that at the outward facing side of the opening (56) having the constriction an insertion chamfer (57) is provided, by means of which (57) the fixing band (55) is guided into the groove (54).

9. The occlusal splint arrangement according to any one of claims 1 to 8, characterised in that at the opening of the groove (25, 28) fixing pins (30) and / or fixing webs (22, 23) which constrict the opening of the groove (25, 28) are provided.

10. The occlusal splint arrangement according to claim 9, characterised in that at least three fixing pins (30) are provided at the opening of the groove (28), fixing pins (30) which are respectively adjacent to each other projecting alternately from the two side edges (31, 32) of the groove (28) into the opening, and / or in that at least one fixing web (22, 23) is provided at the opening of the groove (25), the fixing web (22, 23) extending continuously between the two lateral ends (14) of the groove (25).

11. The occlusal splint arrangement according to any one of claims 1 to 10, characterised in that the cross section of the groove (54) is at least slightly smaller than the cross section of the fixing band (55), the fixing band (55) being fixed in the groove (54) by the press fit formed thereby, in that the fixing band (55) has a circular cross section, in that the cross section of the groove (13, 25, 28) is at least slightly larger than the cross section of the fixing band (05, 26) and the fixing band (05, 26) is displaced along its longitudinal axis without resistance in the groove (13, 25, 28), in that the fixing band (26) has a rectangular cross section, the fixing band (26) running in the incisor region with the longitudinal side of the rectangular cross section parallel to the dental arch, and / or in that the width of the fixing band (26) is larger than the opening cross section of the groove (25), the height of the fixing band (26) being smaller than the opening cross section of the groove (25).

12. The occlusal splint arrangement according to any one of claims 1 to 11, characterised in that the fastening elements (08) at the mandibular miniplast splint (03) are designed like fixing pins (16) which project laterally in the right and the left molar region (09) of the mandibular miniplast splint (03), the ends (06) of the fixing band (05) being hooked onto the fixing pins (16) in a fixing manner.

13. The occlusal splint arrangement according to claim 12, characterised in that a securing element (17), in particular an enlargement, by means of which the fit of the fixing band (05, 26) at the fixing pin (16) is secured, is provided at the free end of the fixing pins (16).

14. The occlusal splint arrangement according to any one of claims 1 to 13, characterised in that at each free end of the fixing pins (39) at least one projection (41, 42) is provided, the projection (41, 42), in a mounting position of the fixing band (40), being inserted into an opening (44) at the end (43) of the fixing band (40), and the projection (41, 42), in a fixing position of the fixing band (40), engaging in a fixing manner behind the opening (44) at the end (43) of the fixing band (40), in that a securing element at the right fixing pin (46) has a different shape than a securing element at the left fixing pin (45), in particular in that the enlargement at the right fixing pin (46) has a different diameter than the enlargement at the left fixing pin (45), the opening at the left end (47) of the fixing band (48) being adapted to the shape of the securing element at the left fixing pin (45) and the opening at the right end (49) of the fixing band (48) being adapted to the shape of the securing element at the right fixing pin (46), in that smooth cover elements (20) are provided adjacent to each fastening element (08) at the mandibular miniplast splint (03), said cover elements (20) projecting in the molar region (09) of the mandibular miniplast splint (03) and laterally covering the fastening elements (08) at least partially, and / or in that markings that indicate the position of the two miniplast splints (34, 35) with respect to each other are attached to the two miniplast splints (34, 35).