"KIT FOR A SELF-MODELLABLE AND CUSTOMISABLE DEVICE FOR TEETH AND MOUTH AND METHOD FOR USING THE KIT FOR SELF-MODELLING AND CUSTOMISING A DEVICE FOR TEETH AND MOUTH"
Cross-reference to related applications
This patent application claims priority from Italian patent application no. 102018000009864 filed on 29/10/2018, the entire disclosure of which is incorporated herein by reference .
Technical field
The present invention relates to the technical field of devices known as "bite/mouth guard" or "mouth protector" which are configured to be housed inside a user' s mouth and coupled to a dental arch. These devices are suitable to perform various functions, among which the treatment of bruxism (i.e., grinding or gnashing of the teeth) , improving sporting performance and protecting the teeth and the mouth from facial traumas .
Background art
Many different devices for protecting the teeth and the mouth are currently available on the market. In particular, devices in the form of endo-oral appliances of plastic type to be placed in the mouth to protect the upper or lower dental arch are known. These devices consist of a U-shaped body to define two lateral arms and a frontal portion for complementary connection to a dental arch. Usually, these devices are made by moulding a portion for receiving the teeth on a supporting base. As is known, the supporting base is in turn made by moulding a plastic material with greater stiffness and greater resistance to heat with respect to the plastic materials used for moulding the portion for receiving the teeth. The supporting base is usually a substantially uniform thin body and in use collaborates with the opposing dental arch, i.e., the dental arch that remains outside the device. Anchoring protrusions, at least partly penetrating into the receiving portion of the teeth, extend from the base. The portion for receiving the teeth has a U-shaped section with side walls for coupling with the vestibular-palatal walls of the dental arch and a base wall against which the chewing surface (or top) of the tooth abuts. It is known that this U-shaped section that cooperates with the lateral and top surfaces of the teeth is shaped to define a plurality of cavities or seats, each of which has a profile substantially corresponding (based on statistics) to the related tooth to be housed. The free arms of the device couple with the back teeth, i.e., the molars, premolars and canines while the connecting frontal portion of the arms couples with the incisors. The use of these devices is very simple and only involves insertion and extraction of the device into and from the user's mouth when required. To enable better adaptation to the different shapes of the dental arches of different users, devices of self-modelling or customisable type are currently known. These devices are made at least partly, i.e., at least the portion that comes into contact with the teeth, of a plastic material that when taken to a given temperature becomes modellable to enable the mouth protector to be modelled according to a specific dental arch. For example, in the most widespread procedure for customising the device, the device is immersed in hot water, for example in boiling water, for a few seconds and the hot device is then tightened with the teeth. Due to the plastic material used in this way, the portion for receiving the teeth is customised according to the dental profile impressed in the hot device by the user. Once cooled, the device permanently maintains this impressed shape corresponding to the user's dental profile. To enable safe and comfortable handling of the device during the steps of immersion in hot water and the subsequent step of first tightening in the teeth, the kit that contains the mouth protector is also provided with a special accessory known as "fork" or gripping device. This fork has a portion configured to be coupled to the device and a portion configured to offer the user a manual holding area outside the device. Therefore, before starting the steps of immersing the device in hot water the device must be coupled to the relative fork. The device is then handled by means of this fork. Although devices for protecting mouth and teeth of the type described above are currently widely available and used, they are not without aspects that can be improved or drawbacks that can be solved. A first drawback of these self-modelling devices (which are aimed at being suitable to be used by all users, regardless of their different mouth shapes) concerns the adaptability of the device to the different dimensions of the dental arches. In the case in which the device is too long with respect to the sagittal dimension of the dental arch, i.e., if it extends distally beyond the seventh molar impacting on the mucous membrane, after or before the first tightening for shaping, the user can shorten the device by cutting part of the its free ends, thereby reducing the painful penetration of the mucous membrane. As this operation is carried out manually by the user, situations can occur in which the cut is not precise and creates sharp edges or portions with an undesirable profile which, when the device is inserted into the user' s mouth, creates a feeling of discomfort or even lesions in the portion of mouth involved. Nonetheless, providing devices of shorter length to avoid this manual cutting is not a solution that is recommended. In fact, in this case some of the innermost teeth, such as the second molars, might remain on the outside of the device. It has been verified that if the user were to wear the device for several hours a day and for several days, this could cause an eruption of the excluded teeth leading to the creation of premature contacts. This condition can then even cause the premature loss of these teeth not housed inside the device. Moreover, known devices for protection of the teeth and the mouth present other drawbacks linked to the portions configured to be coupled with the gripping device. In fact, currently this gripping device is trident-shaped with one or more central pins that couple to respective frontal holes of the device at the level of the incisors and with two outer arms that externally surround almost the whole length of the arms until coupling to the rear ends. In this configuration, during the first tightening the user experiences resistance both at the incisors, where a rigid guide for insertion of the central pins of the gripping device is present, and at the molars where the outer arms of the fork tend to close the mouth protector towards the inside. Moreover, the fact that the known gripping device substantially also directly embracing the arms of the device for protecting the teeth and the mouth limits the possibility of widening or narrowing this device according to the different transverse dimension of the dental arch, or transverse "width" of the user's mouth. Moreover, this embracing of the gripping device around the arms of the device for protecting the teeth and the mouth involves the presence of pin elements of the fork penetrating into the arms of the device transversely. As the fork is made of a harder plastic material with respect to the device, the presence of these pins makes it impossible to model the device locally even with the correct tightening action of the teeth. Finally, also the modelling steps of known devices are not without problems. In fact, due to the natural shape of human dental arches, at least one subsequent modelling step of the device for protecting the teeth and the mouth is almost always necessary, as during the natural tightening greater pressure is applied at a specific area of the arch. Due to the partial modelling steps possible by means of the present invention, the present device enables the reproduction of the most natural tightening condition possible.
For example, during the first tightening it is normal to model only the right or left part of the device and then model the remaining part with another tightening after immersing the device in hot water again. As the known gripping device is configured to produce a single coupling that determines a single positioning relative between this device and the mouth protector, currently it is recommended to immerse the whole device in hot water. In fact, the only coupling currently possible between fork and device is not suitable to handle the device in order to immerse only one or the other portion in hot water. An example of this prior art is described in ER0875265.
Description of the invention
Starting from this prior art, an object of the present invention is to produce a kit or assembly or pack of a device for mouth and teeth, in particular for protecting the teeth, suitable of overcoming the drawbacks of the prior art cited above. In particular, an object of the present invention is to produce a kit or assembly or pack of a self-modellable and customisable device for mouth and teeth that can be comfortably used by all users regardless of the sagittal, frontal and transverse dimensions of the dental arch, i.e., of the length (longitudinal dimension) and of the width (transverse dimension) of the mouth. In particular, the kit comprises a self-modelling and customisable device for mouth and teeth as will be described hereinafter and a gripping device for its handling during the self-modelling and customising operations. The two devices that form the kit of the present invention and the method for using this innovative kit shall now be described.
By the term device for mouth and teeth we mean a specific device known to the person skilled in the art as mouth guard for the treatment of bruxism or for protecting the teeth in general. As is known, these devices are U-shaped to comprise two lateral arms for coupling with the molars, premolars and canines, and a connecting frontal portion for coupling with the incisors. By the term self-modelling we refer to those devices at least partly, i.e. at least at the coupling area with the teeth, made of a plastic material configured to deform with heat and subsequently maintain the dental impression left on the hot device. In fact, after being removed from the pack, these devices must be preliminarily heated, for example by immersing them for a few seconds in boiling water, and shaped by at least one tightening in the mouth with the device still hot. In this generic configuration, according to the invention each lateral arm of the device comprises at least one invitation to cut configured to help the user to manually shorten the length of these arms.
Advantageously, thanks to the present invention, if a user has a limited length of the mouth such that the original length of the arms could cause the ends of these arms to abut uncomfortably against the inside of the user' s mouth, it is now possible to shorten the arms in a guided or facilitated way so as to make a precise cut of the ends. This facilitated cut prevents the formation of bothersome sharp edges or portions that are not correctly finished.
As is known, the lateral arms comprise a base wall, an outer side wall and an inner side wall substantially orthogonal to the base wall. This structure defines a receiving cavity for the lateral portions of the dental arch. In this configuration of the lateral arms, according to an embodiment of the invention, the invitation to cut extends substantially along the whole of the sagittal (or transverse) extension of the base wall of the arms and orthogonal to the U-shaped direction of extension of the device.
Advantageously, in this way the end cut is guided substantially along the whole of the perimeter extension of the device, i.e., entirely along a direction orthogonal to the extension of the arms.
Starting from the embodiment described above, the invitation to cut can also extend at least partly along the side walls, i.e., also along part of the extension of the side walls orthogonally to the base wall.
Moreover, a plurality of invitation to cut lines can be provided at the inner side wall to enable the device to adapt better to the shape of the user's tongue. In particular, it is possible to provide a plurality of invitation lines configured to further smooth or reduce the inner edge of the inner side wall of the device.
Advantageously, this feature makes it possible to prevent another drawback that can currently occur using prior art devices, i.e., an excessive gag reflex, which at times can even cause vomiting.
By the term "invitation to cut" we mean a line or area along which the relative arm offers a lower shear strength. Examples of this feature can be a line with a reduced section, a line along which there are indentations that define a reduced thickness or, according to a preferred embodiment, this invitation to cut can be a through-opening in the shape of a slot along a cutting direction.
Advantageously, in this way not only is there continuity of the invitation to cut between the base wall and the side walls, but it is also possible to prevent sharp edges or portions that are not correctly cut and could be uncomfortable for the user.
Advantageously, the presence of this through slot makes it possible to insert an end of a cutting member, such as a cutter or scissor blade, into the cutting line, so as to greatly reduce the force required by the user to make the desired cut. Even more preferably, the invitation to cut can be produced in a hybrid form in which both a through-opening and a portion of reduced thickness are present. This last embodiment is easily reproduced when the device is made (as known) by joining (preferably, by moulding) two separate bodies, i.e., a substantially flat U-shaped base on which the remaining part of the shaped device is moulded with the receiving cavity of the teeth. As is known, the portion that defines the receiving cavity of the teeth is made of a heat-deformable plastic material to enable customising of the device, while the base is made of a stiffer plastic material, i.e., with a lower deformability with respect to the remaining part that must be modelled by the user. In this configuration, the invitation to cut comprises a first elongated or slotted through-opening made in the base and a second through-opening or cut produced on the yielding body in which the due openings are superimposed and have different length. In particular, the opening produced in the base has a shorter length with respect to the cut produced in the yielding portion. In this way, when assembled the assembly has a through-opening only at the opening of the base and a portion of reduced thickness at the remaining portions of the cut of the yielding body.
Advantageously, in this way on the one hand the user is provided with an actual guide for cutting (if required) and on the other (if cutting is not required) the integrity of the device is guaranteed. In fact, after heating in boiling water the parts separated by this invitation to cut are joined, merging together under the action of the first tightening of the user.
Preferably, the base body has a decreasing thickness starting from the frontal portion towards the lateral arms so as to follow the natural shape of the mouth and make the first tightening for modelling of the device more effective. Preferably, the base body comprises protrusions penetrating into the receiving body of the dental arch and these protrusions have an elongated shape along the extension of the arms. In this way, a firm coupling of the base with the deformable portion is guaranteed also in the presence of arms with marked extensions that require a cut before use. Moreover, the protrusions are made at the teeth with spaces between these protrusions. This embodiment is an optimal compromise between the need to provide the device with structure at the teeth and the need to be able to deform the device according to the different geometry of the user's mouth .
Preferably, the deformable portion has a plurality of cavities in which each cavity is destined to receive a corresponding tooth. In particular, the cavity for receiving the canine has entrance and exit portions with unbevelled or sharp corners. Advantageously, the Applicant has verified how this provides an optimal grip of the device on the dental arch preventing unwanted detachments thereof.
According to an embodiment of the invention, each lateral arm comprises a plurality of substantially parallel invitations to cut spaced along the U-shaped extension of the device.
Advantageously, in this way not only is the cut guided but the user is also offered greater possible customisation of the device according to the transverse dimension and the actual length of the longitudinal dimension of the dental arch.
Preferably, the inner side wall has an extension orthogonal to the base less than the outer side wall so as to offer greater comfort to the tongue and reduce the probability of causing gag reflexes.
For the same purpose, i.e., to reduce gag reflexes deriving from contact of the tongue with the inner walls of the device, these have a plurality of invitations to cut configured to enable the progressive elimination of material from the inner edge of the inner wall of the device, material which, if not removed, might cause the above-mentioned gag reflexes in some users. Incidentally, the presence of these invitations to cut along the inner walls of the device can also be independent of the presence of the invitations to cut present on the base of the arms of this device.
As mentioned previously, the kit of the present invention also comprises a particular gripping device (or fork) configured to be coupled in a releasable way to a device for the mouth and teeth as described. According to the main aspect of the gripping device, this latter comprises a plurality of optional coupling portions with the device.
Advantageously, in this way the device can be handled according to different configurations by means of a single gripping device. In fact, during the steps of customising the mouth protector, successive and partial immersions of the device in hot water are required, leaving a remaining portion already modelled outside. As stated previously, in fact, in the first tightening only part of the device is correctly modelled. In this case, the gripping device can be coupled to the device with an angle that facilitates the immersion of only the desired area. For example, it is commonly necessary to immerse only one arm of the device, leaving the remaining arm out of the water.
According to an embodiment of the gripping device, this latter comprises at least two coupling portions with the device angled at 90° from each other. Preferably, the gripping device is cross-shaped wherein each arm comprises a coupling portion. According to this last embodiment, it is also possible to couple the gripping device internally to the device to immerse even just the relative frontal portion in hot water.
In light of the description above, the present invention also relates to a method for using the kit for modelling and customising the device for mouth and teeth described. In particular, the method comprises the steps of:
a) providing a kit of a device for mouth and teeth as described previously, i.e. comprising a device for mouth and teeth with the innovative invitations to cut and a gripping device provided with at least two optional or alternative coupling portions angled from each other;
b) coupling a coupling portion of the gripping device to the device for mouth and teeth;
c) immersing at least part of the device for mouth and teeth in hot water, by handling it by means of the gripping device; d) making the first tightening of the dental arch in the device, by handling it by means of the gripping device;
e) cutting the end portions of the arms at the invitations to cut .
Alternatively, the step of cutting the ends of the arms can be carried out before immersing the device in hot water.
In the case in which during the first tightening only one portion, for example only one arm, of the device were to be correctly customised, due to the natural imperfect symmetry of the dental arch, the method of the present invention further comprises the steps of:
f) releasing the gripping device;
g) coupling another coupling portion of the gripping device with the device;
h) immersing at least part of the device in hot water again, by handling it by means of the gripping device.
Advantageously, in this way the device is immersed in water again only at the portions not perfectly customised without the risk of scalding the hand that handles the gripping device .
Brief description of the drawings
Further features and advantages of the present invention will be more apparent from the description below of a non-limiting embodiment thereof, with reference to the figures of the accompanying drawings, wherein:
- Fig. 1 shows a perspective view of a first embodiment of a device for teeth and mouth according to the present invention;
- Fig. 2 shows a top view, i.e., from the side for receiving the teeth, of the device of Fig. 1;
- Fig. 3 shows a bottom view, i.e., from the opposite side with respect to Fig. 2, of the device of Fig. 1;
- Fig. 4 shows a sectional view of the device of Fig. 2 along the section lines IV-IV;
- Fig. 5 shows a plan view of an embodiment of a gripping device according to the present invention configured to handle the device of Fig. 1;
- Figs. 6 and 7 show two different possible coupling configurations of the device of Fig. 1 with the gripping device of Fig. 5;
- Fig. 8 shows a top view, i.e. from the side for receiving the teeth, of a second embodiment of the device of the present invention; and
- Fig. 9 shows a third embodiment of the device of the present invention .
Description of an embodiment of the invention
With reference to the accompanying figures, Fig. 1 shows a perspective view of a first embodiment of a device for teeth and mouth 1 according to the present invention. As can be seen, this device 1 is U-shaped to define two opposite arms, respectively a right arm 2 and a left arm 3, and a connecting frontal portion 4 with the arms 2 and 3. As already mentioned, the arms 2 and 3 of the device 1 are destined to couple (starting from the free end) to the molars, to the premolars and to the canines of a dental arch of a user, while the frontal portion 4 couples with the remaining teeth, i.e., the incisors. According to the example shown, the device 1 of Fig. 1 is made by moulding two different bodies, respectively a base body 12 (represented with shading and a dashed line) and on which a receiving body of the teeth 11 is moulded. This receiving body of the teeth 11 is made of a material with greater deformability with respect to the base 12 (greater details about the materials used were described previously in view of the greater deformability required by the body 11 with respect to the base 12) and comprises a plurality of cavities or seats 21 having a shape complementary to the related tooth to be housed. Fig. 1 shows how the base portion 12 comprises projecting portions or protrusions 14 facing towards the upper portion 11 to ensure a stable coupling of the two portions 11 and 12. Moreover, the base 12 also comprises lateral protrusions 14' for the same purpose. The projecting portions 14 have in particular an extension elongated along the arms 2 and 3 so as to offer a greater structural support to the device 1. In fact, according to the present invention, the device 1 purposely has a length of the arms 2 and 3 such as to require some users to act manually to shorten them. On the contrary, according to the prior art these protrusions have a circular profile in view of the shorter length of the arms of the device. To guide and help the user during the steps to shorten the arms, i.e., during cutting of part of the free ends of the arms 2 and 3, as can be seen in Fig. 1 each of the arms 2 and 3 comprises an invitation to cut 5 at the ends of the arms 2 and 3. As will be described hereinafter with reference to Fig. 2, these invitations to cut 5 are in the shape of a lowered section 10 along a direction transverse to the arms 2 and 3 inside which a through-opening 9 is present. In Fig. 1 it can be seen how the invitation to cut 5 extends transversely along the whole of the mouth protector 1, i.e., substantially along the whole of the transverse extension of the last cavity 21. As can be seen, the portion for receiving the teeth 11 has a U-section both at the arms 2 and 3 and at the frontal portion 4 to define a receiving cavity of the dental arch, and the invitation to cut 5 extends both into the base wall 6 and into the inner 7 and outer 8 side walls of the U-shaped section of the arms 2 and 3. Fig. 1 also shows a frontal receiving seat 22 in the form of a hole parallel to the base 12 configured to receive a coupling portion of a gripping device which will be described hereinafter. Finally, Fig. 1 shows the particular shape of the base 12, which at the seat 22 has no element projecting towards the incisors that can in any way offer resistance to tightening in this position .
Fig. 2 shows a top view of the device 1 of Fig. 1 in which it can be seen how the invitation to cut 5 according to this example is made. In particular, Fig. 2 shows how the invitation to cut 5 comprises a central through-opening 9 along the invitation to cut line and lateral portions with reduced thickness 10. In particular, this invitation to cut 5 is made by providing a through-opening 13 of the base body 12 superimposed on a corresponding through-opening produced in the portion 11 for receiving the teeth which however has a transverse extension greater than the through-opening 13 produced in the base 12. Fig. 2 also shows how the cavity for receiving the canines (indicated with the reference 15 to distinguish it from the remaining cavities 21) has entrance and exit edges with unbevelled or sharp corners 16. Moreover, at these cavities for receiving the canines 15, protrusions 14 of the base 12 housed flush in related openings of the base wall 6 of the receiving body of the teeth 11 can be viewed.
Fig. 3 shows a bottom view of the device of Fig. 1, i.e., a plan view of the device 1 from the opposite side with respect to the view of Fig. 2. With this view it is possible to see the profile of the base 12 and the extension of the through- opening 13 of the invitation to cut 5. In Fig. 3 it can also be seen how the seat 22 is made in the shape of a through- opening parallel to the base 12 in the frontal portion 4.
Fig. 4 shows a section of the device 1 of Fig. 2 along the section lines IV-IV. In particular, this Fig. 4 shows how the inner wall 7 has a height orthogonal to the base 12 shorter with respect to the outer wall 8 to ensure greater comfort for the user's tongue.
Fig. 5 shows a plan view of an innovative gripping device 17 according to the present invention configured to be coupled to the mouth protector 1 described above and for enabling the user to handle it without the risk of scalding during the steps of immersion in hot water and of first tightening. In particular, the gripping device 17 of Fig. 5 comprises a cross-shaped body in which each arm of this cross is provided with a coupling portion configured to be coupled to the frontal receiving seat 22 of the device 1. In detail, the gripping device 17 of Fig. 5 comprises a frontal coupling portion 18 configured to be coupled to the frontal receiving seat 22 of the mouth protector 1 so that the gripping device 17 remains outside the mouth protector 1. At this frontal coupling portion 18 the gripping device 17 further comprises a shaped portion 23 configured to abut against the outer surface of the frontal portion 4 of the device 1. On the opposite side the gripping device 17 comprises a rear coupling portion 20 configured to be coupled to the seat 22 internally with respect to the device 1. This coupling is particularly useful when it is required to immerse the frontal portion 4 of the device 1 in hot water. The gripping device 17 comprises, at the rear coupling portion 20, an enlarged area 24 to facilitate grasping by the user. Finally, the gripping device 17 also comprises two lateral coupling portions 19 angled at 90° with respect to the frontal and rear coupling portions. This lateral coupling is particularly useful when it is required to immerse only the right arm 2 or left arm 3 of the mouth protector 1 in hot water.
Figs. 6 and 7 respectively show the gripping device 17 coupled to the device 1 at the frontal coupling portion 18 and one of the lateral coupling portions 20.
Fig. 8 shows a top view, i.e., from the side for receiving the teeth, of a second embodiment of a device 1' according to the present invention. By comparing Fig. 8 with Fig. 2 it can be seen how this embodiment differs from the previous embodiment for the fact of having two invitations to cut 5 for each of the arms 2 and 3 of the device 1' . In this example, the invitations to cut 5 are made in the same way as those shown in Fig. 2. By making the cut, along the one or the other invitation to cut 5, of an arm 2 or 3 the user can further customise the length of the arms 2 and 3 according to three different possibilities and consequently better adapt the device 1' to the actual dimensions of the palate.
Finally, Fig. 9 shows a third embodiment of the invention according to which the inner wall 7 is further provided with a plurality of invitations to cut 26', 26" 26"' configured to remove the inner edge of the inner side wall 7 incrementally. As it has been found that an excessive or suboptimal contact of this inner side wall 7 with the user' s tongue can cause distress and vomiting, the present invention enables the device to be customised also in this sense. In fact, in the case of the distress described above occurring, the user must simply make a cut along the first invitation to cut 26' and to verify whether this reduction of the inner wall 7 is sufficient. In the case in which this removal is not sufficient, according to the example shown the user has two further invitations to cut 26" and 26"' to progressively further reduce the inner edge of the inner wall 7. Naturally, the invitations to cut on the inner walls 7 are independent from the geometry of the frontal portion 4 which can, for example, be of the type shown in Fig. 9.
The embodiments of the invention, shown in the figures described above, refer to devices configured to couple with the upper dental arch of the user's mouth. However, the present invention, i.e., the presence of invitations to cut on the arms of the device and the related features, can also be applied to devices for mouth and teeth with a different geometry, such as devices configured to be coupled with the lower dental arch of the user's mouth.
Finally, it is evident that modifications and variants can be made to the invention described herein without departing from the scope of the appended claims.