APPARATUS FOR MECHANICAL STIMULATION FOR IMPROVING ARTICULAR FUNCTION OF TEMPOROMANDIBULAR JOINTS

The present invention relates to an apparatus for mechanical stimulation for improving articular function of temporomandibular joints, that allows in a simple, fast, safe and painless way, to relax the peripheral musculature of such joints and to help unlocking intra-articular menisci, improving the articular and masticatory functions and contributing to create a neutral and balanced posture of such joints, the apparatus being highly reliable, efficient, simple to use and inexpensive.

It is known that the temporomandibular joints, also called TMJs, perform the function of articulating the complex movement of the mandible along the three planes of space, which are fundamental for mastication and phonation. Pathologies affecting the TMJ are particularly dangerous, causing not only disorders to mastication and phonation, but causing also a complex derived symptomatological pattern that may involve the dental apparatus, the statokinetic apparatus of the inner ears, the vertebral column and the related musculature. By way of example, recent studies have shown that a distortion of the correct posture of the TMJs may contribute to also distort body posture, causing disorders to the postural balance and contractures harmful most of all harmful to the musculature of neck and back.

Present therapies for remedying TMJ pathologies aim at unlocking intra-articular menisci and/or a t making the TMJ to assume again a neutral and balanced posture through the application of a removable dental plaque, called "bite", substantially consisting in a, preferably rigid, plate that is placed among tooth for rebalancing the muscle tone and posture of the TMJ. To this end, it is necessary that the bite adapts to the balanced arrangement of the patient's dental arches.

However, present therapies suffer from the drawback that the bite is made on the basis of a dental arch core that is taken when the TMJ joint is still subject to an unbalanced posture.

Moreover, bite manufacture is rather expensive, also considering the fact that it is often necessary to replace one or more bites during treatment.

In this context, the solution proposed according to the present invention is introduced.

Hence, it is an object of the present invention to allow, in a simple, fast, safe and painless way, a relaxation of the peripheral musculature of the temporomandibular joints.

It is still an object of the present invention to help unlocking intra-articular menisci, improving the articular and masticatory functions and contributing to create a neutral and balanced posture of such joints.

It is therefore specific subject matter of this invention an apparatus for mechanical stimulation for improving articular function of temporomandibular joints, comprising stabilisation mechanical means connected to support mechanical means, and vibrating means capable to produce at least one mechanical vibration of said support mechanical means, said support mechanical means being capable to get in contact with a patient so as to transmit said at least one mechanical vibration to at least one temporomandibular joint of the patient, said stabilisation mechanical means being capable to stabilise the contact between said support mechanical means and the patient.

Always according to the invention, said at least one mechanical vibration may occur at a frequency ranging from 1 Hz to 1000 Hz, preferably from 1 Hz to 500 Hz, more preferably from 20 to 60 Hz. Still according to the invention, said at least one mechanical vibration may have an amplitude ranging from 1 to 10 mm, preferably from 1 mm to 7 mm, more preferably from 2 mm to 5 mm.

Furthermore according to the invention, said vibrating means may be capable to regulate a frequency and/or an amplitude of said at least one mechanical vibration.

Always according to the invention, said vibrating means may be coupled, preferably in a removable way, to said support mechanical means.

Still according to the invention, said vibrating means may comprise electromechanical means.

Furthermore according to the invention, said electromechanical means may comprise at least one eccentric operated by at least one corresponding electric motor.

Always according to the invention, said vibrating means may comprise magnetomechanical means.

Still according to the invention, said magnetomechanical means may be operated by control electronic means.

Furthermore according to the invention, said vibrating means may be supplied by rechargeable batteries.

Always according to the invention, the apparatus may comprise at least one sensor, preferably capable to detect at least one amplitude and/or at least one acceleration and/or at least one speed of said at least one mechanical vibration and to provide one or more signals representative of the detection.

Still according to the invention, said at least one sensor may comprise at least one three-axis accelerometer. Furthermore according to the invention, the apparatus may comprise at least one memory for storing said one or more signals representative of the detection.

Always according to the invention, the apparatus may comprise at least one processing unit, connected to said at least one sensor, capable to determine at least one optimal vibration on the basis of said one or more signals representative of the detection received from said at least one sensor and to accordingly control said vibrating means.

Still according to the invention, the apparatus may further comprise at least one memory for storing one or more data processed by said at least one processing unit.

Furthermore according to the invention, said stabilisation mechanical means may comprise an intrabuccal structure and said support mechanical means may comprise a mandibular structure, the intrabuccal structure and the mandibular structure being coupled to each other through a hinged, preferably elastic, connection, the mandibular structure being capable to get in contact at least with an antero-inferior part of the mandibular bone of the patient, the intrabuccal structure being capable to lie on the lower dental arch of the patient.

Always according to the invention, the hinged connection between the intrabuccal structure and the mandibular structure may comprise a pin inserting in corresponding holes alignable to each other of the intrabuccal and mandibular structures, and a spring the ends of which are housed in corresponding rear seats of the intrabuccal and mandibular structures. Still according to the invention, the intrabuccal structure may comprise a shaped plate frontally provided with an arched portion, capable to lie on the lower dental arch of the patient.

Furthermore according to the invention, the front arched portion may be removably coupled to the shaped plate.

Always according to the invention, the front arched portion may be inferiorly provided with a layer of soft material, preferably a silicone one and/or a spongy one.

Still according to the invention, the front arched portion may be provided with adjustment mechanical means for adjusting its shape and/or its size.

Furthermore according to the invention, the shaped plate may have shape of a "Y" having two front arms being part of said front arched portion.

Always according to the invention, the shaped plate may be backward provided with a cylinder that is at least inferiorly hollow, operating as seat for an end of the spring, and with a lower central shaped plate provided with one or more holes for housing the pin.

Still according to the invention, the mandibular structure may comprise a shaped base provided with a front portion, preferably provided with adjustment mechanical means for adjusting its shape and/or its size, capable to lie on the chin of the patient. Furthermore according to the invention, the shaped base may have shape of a "Y" having two front arms being part of said front portion.

Always according to the invention, the shaped base may comprise two side portions, preferably removable, capable to lie up to two angles between the body and the rami of the mandible of the patient. Still according to the invention, the shaped base may comprise two further side portions, preferably removable, more preferably adjustable, capable to lie on the temporomandibular joints of the patient.

Furthermore according to the invention, the front portion may be superiorly provided with a layer of soft material, preferably a silicone one and/or a spongy one.

Always according to the invention, the shaped base may be backward provided with a cylinder at least superiorly hollow, operating as seat for an end of the spring, and with an upper central shaped plate provided with one or more holes for housing the pin. Still according to the invention, said stabilisation mechanical means may comprise two side arms, preferably adjustable in length, hinged on each other so as to be capable to form a "U" similarly to a

stethoscope, and said support mechanical means, preferably adjustable, may be capable to lie on the temporomandibular joints of the patient.

Furthermore according to the invention, the two side arms may be elastically hinged on each other. Always according to the invention, said support mechanical means may comprise or consist of two free ends of the side arms, preferably incorporated in these.

Still according to the invention, said support mechanical means may comprise two shaped plates coupled, preferably removably, to two respective free ends of the side arms.

Furthermore according to the invention, said two shaped plates may be two discs.

Always according to the invention, a surface of said two shaped plates may be provided with a suction cup or a gummy element. Still according to the invention, said vibrating means may comprise an electromechanical and/or magnetomechanical device housed in a hinge connecting the two side arms.

Furthermore according to the invention, said vibrating means may comprise two electromechanical and/or magnetomechanical devices coupled to said two free ends of the side arms.

Always according to the invention, said vibrating means may comprise two electromechanical and/or magnetomechanical devices coupled to said two shaped plates.

The advantages offered by the apparatus according to the invention, thanks to the application of a vibration to the TMJs, are numerous and very significant.

First of all, the apparatus according to the invention allows the TMJ peripheral musculature to be relaxed, restoring neutral conditions (it could be said "resetting") of the masticatory muscles, which are often source of tensions leading to temporomandibular malfunctions.

Moreover, the apparatus according to the invention helps unlocking intra-articular menisci, with a consequent increase of the movement extension or R. O. M. (range of motion) of the TMJ and an improvement of the general function of the joints and of the mastication. Also, the apparatus according to the invention improves the articular and masticatory functions in degenerative arthrosic pathologies, increasing joint trophism and lubrication and creating a condition of better

articular dynamic function.

Furthermore, the apparatus according to the invention contributes to create a state of neutrality and balance between the two opposed temporomandibular joints. Moreover, the apparatus according to the invention improves the whole postural aspect of the TMJs through an improvement of the occlusal function, also depending on the positioning of a functional orthodontic apparatus as a release plaque or the like.

Also, the apparatus according to the invention aids the diagnosis of occlusal malfunctions through means for detecting static and/or dynamic balance and observation of the behaviour of postural tonic activity.

Furthermore, the apparatus according to the invention modifies the occlusal afferency through reinformation of osteoarticular and muscular proprioceptive receptors as the neuromuscular spindles, Golgi tendon organs, cutaneous receptors, pacinian corpuscles, etc., largely present in the whole temporomandibular region.

Moreover, the apparatus according to the invention determines the centric occlusion centric relationship of the mandible. In fact, bringing mandible and maxilla back in centric axis means to muscularly centre the two dental arches and the related condyles in the respective glenoid fossas.

Also, the apparatus according to the invention helps mandible release and improves the whole postural aspect that often is strongly affected by the occlusal condition.

The present invention will be now described, by way of illustration and not by way of limitation, according to its preferred embodiments, by particularly referring to the Figures of the enclosed drawings, in which: Figure 1 shows a perspective view of a first embodiment of the apparatus according to the invention;

Figure 2 shows a front view of the apparatus of Figure 1 ;

Figure 3 shows a top view of the apparatus of Figure 1 ;

Figure 4 shows a perspective view of a grip on the apparatus of Figure 1 by a user's hand;

Figure 5 shows a perspective view of the apparatus of Figure 1 preliminarily to the application to a patient;

Figure 6 shows a perspective view of the apparatus of Figure 1 in the final position of application to the patient of Figure 3;

Figure 7 shows a side view of the disassembled elements of the apparatus of Figure 1; Figure 8 shows a perspective partial view of the disassembled elements of the apparatus of Figure 1 ;

Ia Figure 9 shows a right side view of a first portion of the apparatus of Figure 1 ;

Figure 10 shows a top view of the portion of Figure 9; Figure 11 shows a bottom view of the portion of Figure 9;

Figure 12 shows a front view of the portion of Figure 9; Figure 13 shows a rear view of the portion of Figure 9; Figure 14 shows a right side view of a second portion of the apparatus of Figure 1; Figure 15 shows a front view of the portion of Figure 14;

Figure 16 shows a rear view of the portion of Figure 14; Figure 17 shows a top view of the portion of Figure 14; Figure 18 shows a bottom view of the portion of Figure 14; and Figure 19 shows a right side view (a), a front view (b), and a left side view (c) of a patient to which a second embodiment of the apparatus according to the invention is applied.

In the Figures, identical reference numbers are used for alike elements.

With reference to Figures 1-4, it may be observed that the first embodiment of the apparatus 1 according to the invention comprises a stabilisation intrabuccal structure 10, coupled to a mandibular support structure 11 through a hinged connection, and an electromechanical device 12 for generating vibrations, coupled to the mandibular structure

11. Other embodiments of the apparatus according to the invention may provide, alternatively to or in combination with the electromechanical device, a vibration generating magnetomechanical device. Also the number of vibration generating (preferably electromechanical or magnetomechanical) devices may be larger than one.

In particular, as illustrated in Figures 5 and 6, the intrabuccal structure 10 allows the apparatus to be stably attached to the mandibular region through a dental support, whereas the mandibular structure 11 , through a contact with the anteroinferior part of the mandibular bone,

transmits the vibrations of the electromechanical device 12 which it undergoes to the mandible and, consequently, it bilaterally transmits them to the TMJs of the patient 20.

With reference to Figures 7 and 8, it may be observed that the stabilisation intrabuccal structure 10 is coupled to the mandibular structure 11 though an hinged elastic connection comprising a pin 13, that inserts in corresponding holes 14 and 15 alignable to each other, and a spring 16 the ends of which are housed in corresponding cylindrical hollow seats with which the rear ends of the structures 10 and 11 are provided. The pin 13 allows a mutual rotation of the structures 10 and 11; the spring 16 tends to oppose the spacing between the front ends of the structures 10 and 11 , so as to aid a stable contact of such ends with respectively the lower dental arch and con the mandibular bone of the patient 20 (as shown in Figure 6). As shown in Figures 4 and 5, in order to apply the apparatus 1 to a patient 20 it is necessary to press the rear ends of the structures 10 and 11 so as to compress the spring 16 and to space the front ends to position, respectively, on the lower dental arch and under the chin of the patient 20.

The electromechanical device 12 (that in Figure 8 is shown as partially lacking its own case) is coupled to the mandibular structure 11 , preferably in a removable way through either slides, inferiorly or frontally positioned on the mandibular structure 11 , or fast fixing connections, so as to help assembling and disassembling (e.g. for allowing structures 10 and 11 to be sterilised in autoclave). With reference to Figures 9-13, it may be observed that the stabilisation intrabuccal structure 10 of the first embodiment of the apparatus according to the invention comprises a Y-shaped plate 100 provided with a backward lower hollow cylinder 101 and with a lower central shaped plate 102 having two lower projections 103 provided with the holes 14 for housing the pin 13.

The two front arms 104 of the "Y" are capable to get in direct contact with the lower dental arch of the patient 20 (as shown in Figure 6). In particular, different e mbodiments o f the apparatus ace ording to the invention may provide that the portion being in direct contact with the lower dental arch has variable shapes and size such that the contact concerns either only the front part or the whole lower dental arch.

The two front arms 104 of the "Y" are inferiorly provided with a

layer 105 of soft material, e.g. a silicone one, a spongy one or other, so as to attenuate or completely block vibrations transmitted to dentition. In fact, the stabilisation intrabuccal structure 10 operates only as stable and comfortable support for the user. Other embodiments of the apparatus according to the invention may comprise adjustment mechanical means capable to vary the width of the dental support base (i.e., in case of the intrabuccal structure 10 of Figures 9-13, the distance between the front arms 104), for making it possible to perfectly support different types of dental arches. The lower central shaped plate 102 operates as stiffener for the structure 10, besides constituting part of the hinged connection with the mandibular structure 11 through the lower projections 103 provided with the holes 14. In this regard, other embodiments of the apparatus according to the invention may provide a plurality of holes along the height of the projections 103 so as to allow an adjustment of the height of the apparatus for aiding its application to several patients by simply varying the position of the pin 13.

The lower hollow cylinder 101 with which the plate 100 is provided operates as seat for the upper end of the spring 16, and it offers a surface for manual grip by a user who must compress the same spring (as shown in Figures 4 and 5).

With reference to Figures 14-18, it may be observed that the mandibular support structure 11 of the first embodiment of the apparatus according to the invention comprises a shaped base 110 provided with a backward upper hollow cylinder 111 and with a upper central shaped plate 112 having three upper projections 113 provided with the holes 15 for housing the pin 13.

The front portion of the base 110 is capable to lie on the chin of the patient 20 (as shown in Figure 6) for transmitting to the antero-inferior portion of the mandible body the vibrations generated by the electromechanical device 12 inferiorly coupled to the same base 110, such that the vibrations propagate up to the TMJs. In particular, such front portion of the base 110 is preferably superiorly provided with a layer 115 of soft material, e.g. a silicone one, a spongy one or other, so as to attenuate the hits of the transmitted vibrations.

Further embodiments of the apparatus according to the invention may provide that the base 110 of the mandibular structure 11 is

Y-shaped similarly to the stabilisation intrabuccal structure 10 shown in Figures 9-13, for better following the mandible portion onto which vibrations are transmitted. Such base 110 of the mandibular structure 11 could further provide a notch and/or a concavity capable to be perfectly shaped as the chin of the patient 20; moreover, the base 110 could further provide adjustment mechanical means of the width of the arms of the "Y" for adapting to different size and/or shapes of jaws of different patients.

Other embodiments of the apparatus according to the invention may provide that the base 110 of the mandibular structure 11 is shaped so as to comprise two side portions (or possibly only one), preferably removable, capable to lie up to the two angles (or possibly only one) between the mandible body and the rami (possibly only one).

Further embodiments of the apparatus according to the invention may provide that the base 110 is shaped so as to comprise further portions, preferably removable, more preferably adjustable so as to adapt to different patients, capable to directly lie on the TMJs (or on only one of them). In this case, the apparatus may provide, alternatively to (or even in combination with) the single electromechanical device 12 inferiorly coupled to the base 110, two electromechanical devices placed at the ends of such further portions so as to transmit the vibrations directly to the TMJs on which such further portions lie.

The upper central shaped plate 112 operates as stiffener for the structure 11 , besides constituting part of the hinged connection with the intrabuccal structure 11 through the upper projections 113 provided with the holes 15. In this regard, the three upper projections 113 define two notches in which the two lower projections 103 of the intrabuccal structure 10 may insert. Other emb odiments o f the apparatus ace ording to the invention may provide a plurality of holes along the height of the projections 113 so as to allow an adjustment of the height of the apparatus for aiding its application to several patients by simply varying the position of the pin 13.

The upper hollow cylinder 111 with which the base 110 is provided operates as seat for the lower end of the spring 16, and it offers a surface for manual grip by a user who must compress the same spring (as shown in Figures 4 and 5).

As said, the electromechanical device 12 of the first embodiment of the apparatus according to the invention is inferiorly

coupled, preferably removably, to the mandibular structure 11 to which it transmits the vibrations which it generates. Preferably, the electromechanical device 12 comprises an eccentric operated by a corresponding electric motor. In the embodiments of the apparatus according to the invention providing, alternatively to or in combination with (at least) an electromechanical device, (at least) one vibration generating magnetomechanical device, this is preferably operated by a control electronics.

The electromechanical device 12 is advantageous supplied by rechargeable batteries, which may be recharged by inserting the electromechanical device 12 (possibly removed from the mandibular structure 11) in a charger similarly to what happens in case of an electric toothbrush. Alternatively, batteries may be recharged by connecting a cable of a charger to the electromechanical device 12, similarly to what happens in case of a cellular telephone.

Other embodiments may provide that the electromechanical device 12 is supplied through wired connection to either the mains, incorporating a possibly necessary transformer, or to a transformer connected in turn to the mains. In the embodiments of the apparatus according to the invention providing (at least) one vibration generating magnetomechanical device, this is advantageously supplied in ways similar to the just described ones.

The vibration frequency preferably ranges from 1 Hz to 1000 Hz, more preferably from 1 Hz to 500 Hz, still more preferably from 20 to 60 Hz.

Moreover, vibration amplitude may be varied on the whole range of frequencies. In particular, the electromechanical device 12 generates vibrations of amplitude ranging preferably from 1 mm to 10 mm, more preferably from 1 mm to 7 mm, still more preferably from 2 mm to 5 mm.

Vibrations may be produced axially, orthogonally or tangentially with respect to the mandible axis, or they may be combined along the three axes of the space for providing different effects.

In particular, the regulation of frequency, amplitude, and direction of the produced vibrations may occur in automatic and/or manual manner by an operator m anipulating o ne or more regulation rotatable buttons and/or elements.

Preferably, the electromechanical device 12 is further provided with a processing unit, for evaluating the optimal vibration frequency, connected to (at least) one sensor. Advantageously, such sensor comprises a three-axis accelerometer capable to detect the accelerations along the three Cartesian axes and to provide the processing unit with signals representative of the amplitude and/or acceleration and/or speed of vibration along the three axes. On the basis of such signals, the processing unit is capable to follow the variations of the vibrations of the mandible and TMJs and/or to determine a level of relaxation of the peripheral musculature of the TMJs and of unlocking of the intra-articular menisci. In this way, the processing unit is capable to characterise the vibrations with precision and, advantageously, to control the electric motor, operating the eccentric for generating the vibrations, in conformity to the feedback received from said (at least) one sensor for adapting the vibrations to what the treatment is producing, thus modifying the features of the vibration depending on the sensor response. In particular, the results of the processing performed by the processing unit may be stored in a memory of the electromechanical device 12 and/or transmitted, through wired or wireless connection, to an external computer. Other embodiments of the apparatus according to the invention may provide that the electromechanical device 12 only comprises (at least) one sensor. In this case, the processing unit performing the evaluation of the optimal vibration frequency (and the possible control of the electric motor operating the eccentric) is external, e.g. constituted by a computer or a personal digital assistant or a different processor, and connected through wired or wireless connection to the electromechanical device 12. The signals detected by the sensor may be stored in a memory internal and/or external to the electromechanical device 12, accessible by the external processing unit. Similar operation modes and similar detection and control electronics may be also provided by the embodiments of the apparatus according to the invention providing (at least) one vibration generating magnetomechanical device.

With reference to Figure 19, it may be observed that a second embodiment of the apparatus according to the invention comprises two side arms 30 and 31 hinged so as to be capable to form a "U" in a manner similar to a stethoscope. The free ends of the side arms 30 and 31 are

provided with respective discs 32 and 33 housing respective vibration generating electromechanical (or magnetomechanical) devices 34 and 35. The lower part of the discs 32 and 33 is advantageously provided with a suction cup or a gummy element allowing it to stably adhere to the skin of the patient 20.

As in a stethoscope, the two side arms 30 and 31 may be connected through such an elastic connection to cause the mutual elastic approach of the free ends of the side arms 30 and 31 , aiding closing of the discs 32 and 33 on the zones of the temporomandibular joints. It is evident that the second embodiment of the apparatus according to the invention allows to apply vibrations directly on the two TMJs and independently from one other.

Alternatively to, or in combination with, the two electromechanical devices 34 and 35 housed within the discs 32 and 33, the apparatus of Figure 19 may comprise a single vibration generating electromechanical device housed in correspondence with the elastic connection 36 between the two side arms 30 and 31.

Similarly to what seen for the first embodiment of the apparatus according to the invention, also the apparatus of Figure 19 may provide that the vibration generating electromechanical device (the electromechanical devices) are provided with (at least) one processing unit, for evaluating the optimal vibration frequency, connected to (at least) one sensor.

Other embodiments may provide that, instead of the discs 32 and 33, the apparatus of Figure 19 comprises differently shaped plates for housing the two electromechanical devices 34 and 35.

Further embodiments may provide that the apparatus of Figure 19 does not comprise discs nor shaped plates for housing the two electromechanical devices 34 and 35, but that these are coupled, preferably in a removable way, directly to the free ends of the arms 30 and 31. In this case, the support mechanical means of the apparatus as defined by claim 1 coincides with such free ends of the arms 30 and 31 , preferably incorporated in the latter.

The preferred embodiments have been above described and some modifications of this invention have been suggested, but it should be understood that those skilled in the art can make variations and changes, without so departing from the related scope of protection, as defined by

the following claims.