FR3106484A1 - NEW DEVICES FOR CORRECTING MAXILLARY AND / OR MANDIBULAR GROWTH DEFECTS - Google Patents

Abstract

The present invention relates to a system intended for the treatment of class II or class III dysmorphoses, and/or OSAS, comprising at least one elastic means and at least one pair of devices each of which comprises a plate to be fixed to the bone of the maxilla or mandible of a subject, which plate does not include any recess intended to allow screws to pass through for fixing the device to the bone, a fixing element for fixing the elastic means and a connecting piece which connects the element of attachment to the plate and which is adapted to extend through the gingiva which surrounds the corresponding bone; as well as a kit comprising such a system and packaging comprising an adhesive substance making it possible to fix the plate of the device to the bone.

Description

NEW CORRECTION DEVICES FOR MAXILLARY AND/OR MANDIBULAR GROWTH DEFECTS

FIELD OF THE INVENTION

The present invention relates to the field of devices correcting dysmorphisms of the orofacial sphere and obstructive sleep apnea syndrome (OSAS).

PRIOR ART

Growth defects in the orofacial sphere in children are the cause of dysmorphisms commonly categorized in class II (maxillary prognathism and/or mandibular retrognathism) and class III (maxillary retrognathism and/or mandibular prognathism

In adults, only surgery can correct these dysmorphoses. LEFORT 1 surgery, in reference to LEFORT fractures, makes it possible to obtain an anterior or posterior displacement of the maxilla, where sagittal splitting surgery of the mandible (Obwegeser, Dalpont, etc.) allows an anterior or posterior displacement of the mandibular entity

Nowadays, these dysmorphoses can also be corrected earlier by using appliances or devices called mandibular or maxillary growth activators, which exert a controlled constraint on the mandible and the maxillae. These devices interact with growth and must be worn systematically at night and for at least part of the day.

In detail, these mandibular growth activators are devices that promote the growth of the mandible through forced propulsion. Maxillary growth activators are devices that promote maxillary growth by placing the mandible in forced retropulsion. These devices can be monobloc, like the BIONATOR from BALTERS, or bibloc.

We know different types of mandibular growth activators. By way of example, we can cite a class II activator of the LAUTROU type (one-piece windowed device in the palatal-incisor region associated with an extra-oral force), a HERBST connecting rod type activator made on rings or pedodontic caps, an activator of the FRANKEL type or of the BALTERS type. Such activators are described for example in PCT international application WO2004/026163 (ORTHOTAIN), PCT international application WO86/04806 (KORN), European patent application EP 0128744 A1 (ROSENBERG), European patent application EP 1108397 A1 (ORTHO ORGANIZERS) and PCT international application WO2004/064662 (ORTHOTAIN).

Most of these devices rely on the patient's teeth and therefore have so-called parasitic effects on both craniofacial growth and dento-alveolar structures. The movements induced are a clockwise rotation of the maxilla and mandible resulting in an increase in the lower level of the face (mandibular growth in posterior rotation). A clockwise tilt of the occlusal plane is also observed. In addition, a vestibuloversion of the mandibular incisor and a palatoversion of the maxillary incisor adds to the initial problem. Risks to periodontal health may thus be incurred.

More recently, a device called Clerck's plates has appeared which allows the treatment of both class II and class III dysmorphoses (for a review, see DE CLERCK & PROFIT, Am. J. Orthod. Dentofacial Orthop .; vol .148(1), p:37-46. 2015).

Insofar as this plate is implemented by screwing directly on the mandible or the maxilla, it does not present the defects of the previous devices in connection with the teeth or with the clockwise tilting of the mandibular, maxillary and occlusal planes.

However, and even if these DE CLERCK plates give satisfactory results, for the treatment of class II or class III dysmorphoses they can only be placed from the age of 11-12 years. This limit is imposed by the fact that these plates can only be implemented after eruption of all the germs of the permanent teeth in order to avoid any lesion due to the screws and, moreover, that the bone density is sufficient to ensure stability. primary of said screws.

The interception of these dysmorphoses using screwed bone anchor plates can therefore only be done late (after 11-12 years) leading to a worsening of these, an extension of the treatment time and the need, most often to resort to orthognathic surgery. This dysmorpho-dysfunctional cascade diagnosed early can sometimes only be interrupted too late. In addition, there is a non-negligible rate of unscrewing of these plates.

SUMMARY OF THE INVENTION

The inventors have now developed a new method which allows the treatment of patients suffering from type II or III dysmorphosis or OSAS before the age of 11 years. This innovative method can also be applied to children and adults suffering from obstructive sleep apnea syndrome (OSAS) and/or class II or III skeletal dysmorphosis. The following may also be concerned: - children with cleft lip and palate, children with Pierre-Robin syndrome, children with a syndrome responsible for craniofacial dysmorphosis.

In this method, plates fixed to the mandible or maxilla are also used. Now, these plates are no longer screwed, but glued in such a way as to ignore the limitations imposed by the DE CLERCK plates.

Also, a first object of the invention relates to a kit, which is advantageously intended for the treatment of type II or type III dysmorphoses, and/or OSAS, and which comprises:

i) at least one pair of elastic means (5), preferably at least two pairs of elastic means, and

ii) at least one device pair (1), preferably at least two device pairs, each comprising:

a) a plate (2) to be attached to the maxillary or mandible bone of a subject;

b) a fixing element (3) for fixing the elastic means (5), which can for example take the form of a hook, a ball or a ring; And

c) a connection piece (4) which connects the fixing element (3) to a plate (2), and which is adapted to extend through the gum which surrounds the corresponding bone;

Characterized in that the plate (2) does not include any recess intended to allow screws to pass through to fix the device to the bone and in that the kit further comprises packaging comprising an adhesive substance allowing the plate (2) to be fixed to the bone.

Advantageously, this adhesive substance is chosen from the group consisting of composite-based cements, cyanoacrylates or any other biocompatible adhesive or cement.

A second object of the invention relates to a system, which is advantageously intended for the treatment of class II or class III dysmorphoses, and/or OSAS, and which comprises:

i) at least one pair of elastic means (5), preferably at least two pairs of elastic means (5), and

ii) at least one pair of devices (1), preferably at least two pairs of devices (1), and which each comprises:

a) a plate (2) to be attached to the maxillary or mandible bone of a subject;

b) a fixing element (3) for fixing the elastic means (5), which can for example take the form of a hook, a ball or a ring; And

c) a connection piece (4) which connects the fixing element (3) to the plate (2), and which is adapted to extend through the gum which surrounds the corresponding bone;

Characterized in that the plate (2) does not include any recess intended to allow screws to pass to fix the device (1) to the bone.

A third object of the invention relates to a device, which is advantageously intended for the treatment of class II or class III dysmorphoses and/or su OSAS, and which comprises:

a) a plate (2) to be fixed to the maxillary bone or to the mandible bone of a subject;

b) a fixing element (3) for fixing an elastic means (5), which preferably takes the form of a hook, a ball or a ring; And

c) a connection piece (4) which connects the fixing element (3) to the plate (2), and which is adapted to extend through the gum which surrounds the corresponding bone;

Characterized in that the plate (2) does not include any recess to allow screws to pass to fix the implant to the bone.

A fourth subject of the invention relates to a method for treating type II or type III dysmorphosis, or OSAS, comprising the steps of:

1) gluing the glued devices (2) of a pair of glued devices (1) on the bones of the maxilla and the mandible on each side of a subject,

2) tensioning of an elastic means between the two devices (1) glued to the maxilla and mandible on each side of a subject.

DESCRIPTION OF FIGURES

Figure 1 is a schematic representation of the device (1) according to the invention seen from different angles.

Figure 2 is a schematic representation of the positioning of a system according to the invention, where a device (1) positioned on the mandible bone of a subject suffering from type II dysmorphosis and a device (1) positioned on the maxillary bone of the same subject are interconnected by an elastomer (5).

Figure 3 is a schematic representation of the positioning of a system according to the invention, where a device (1) positioned on the mandible bone of a subject suffering from type III dysmorphosis and a device (1) positioned on the maxillary bone of the same subject are interconnected by an elastomer (5).

DETAILED DESCRIPTION OF THE INVENTION

In connection with the device according to the invention and its various components (that is to say the plate, the fixing element and the connection part), it is preferably made of any biocompatible and sufficiently resistant material. Examples of such materials include titanium and its alloys, polyetheretherketone (PEEK), zirconia or ceramics.

With regard to the plate (2), it has a sufficient surface to allow its effective bonding to the bone of the mandible or to the bone of the maxilla.

To do this, the surface of this plate (2), which is in contact with the bone of the mandible or with the bone of the maxilla, is greater than or equal to 0.1 cm ² , preferably greater than or equal to 0 25 cm ² , and particularly preferably greater than or equal to 0.5 cm ² .

Advantageously, the surface of this plate (2) is between 0.1 and 1 cm ² , preferably between 0.25 and 0.75 cm ² .

The thickness of the plate (2) is sufficient to ensure its good solidity and depends on the material used.

Advantageously, its thickness is between 0.5 and 5 mm, preferably between 1 and 3 mm.

The plate (2) can have a rounded or rectangular or other shape adapted to the destination bone surface. Now, and in the case of a plate (2) of rectangular shape, care will be taken to round off the angles so as not to risk injuring the periosteum.

If the plate (2) can be flat, it is preferable to give it a curved shape so as to facilitate its adaptation with the bone of the mandible or with the bone of the maxilla (which also has a curved surface).

In order to improve the resistance over time of the plate (2), the surface which is intended to be glued to the bone of the mandible or to the bone of the maxilla is preferably rough (that is to say say not smooth). Examples of rough surfaces include sandblasted, frosted, scratched, ribbed, jagged, etc. surfaces. This choice of surface will be made according to the type of glue used.

In connection with the connection piece (4), it advantageously has a rectangular, circular or elliptical, preferably circular or elliptical or other cross-section. In the case of a rectangular section, its corners will be rounded to avoid injuring the periosteum.

The area of the cross-section of the connection part (4) is less than or equal to that of the bonded device (2), preferably it is less than its area. Preferably, the connecting piece (4) takes the form of a rod.

The length of the connecting piece (4), which crosses the gum, is at least 3 mm, preferably at least 5 mm. The dimensions of the connection piece (4) are such that, depending on the material in which this connection piece (4) is made, they are adapted to the anatomical constraints and to the adjoining mechanical reflection.

Advantageously the connection part (4) is coaxial with the fixing element (3).

The element (3) allows the fixing of an elastic means (5) and its structure depends on the nature of this elastic means (5).

The elastic means may take the form of elastomeric elastics or tension springs, preferably the elastic means takes the form of elastomeric elastics.

The dimensions of the elastic means are such that they make it possible to apply a stress ranging from 0.05 to 20 N (newtons) between the two plates (2), preferably ranging from 0.5 to 8 N and, in a particularly ranging from 1.5 to 6 N.

By way of example, it is possible to choose rubber bands made of elastomer with or without latex with a section of at least 1 mm, preferably of at least 2 mm.

The elastic means used must have a sufficient length so as to be able to connect together 2 devices (1) glued and arranged on the same face of the patient, but on the bones of the mandible and the maxilla respectively. Typically, the elastic means will have to have a length making it possible to connect 2 bonded devices (1) whatever their spacing in adequacy with the constraint to be exerted on the bone or dental system. Such a length is usually between 10 to 100 mm, preferably from 15 to 50 mm and, in a particularly preferred way, from 20 to 40 mm.

In the case of an elastic means (5) taking the form of an elastomeric rubber band, the fixing element (3) may take the form of a hook, a ball, a ring or any another form making it possible to ensure retention of the elastic means (5).

If the plate (2), the connection part (4) and the fixing element (3) can be formed by three or even two separate parts, the option where the three together form one and the same is preferred. piece.

In connection with the packaging of the adhesive substance, it is possible to choose a compressible tube, a syringe or even a two-component syringe for mixing and controlled deposition of two-component materials.

Now, and in connection with a specific embodiment, the substance is previously glued onto the surface of the plate (2) of the device (1) with the adhesive substance. In this case, the device (1) is stored in such a way as to avoid any adhesion with the adhesive substance.

According to a preferred embodiment, the adhesive substance is a composite-based cement.

By composite-based cement is meant a material whose characteristics are as defined in the ISO4049 standard which comprises a dispersed phase comprising the filler (mineral, organo-mineral or organic) coupled, by means of a silane, to the dispersing phase (organic matrix) comprising at least one monomer derived from methacrylate.

The dispersing phase or organic matrix acts as a binder between the fillers. This phase gives a more or less high viscosity to the unpolymerized composite depending on the methacrylate derivative(s) of which it is composed. Note that it is common to use mixtures of different derivatives in order to achieve the desired viscosity. This dispersing phase, however, has a low mechanical strength taken on its own.

A person skilled in the art is able to determine simply, with regard to his general knowledge, the methacrylate derivatives which can be used in dispersing phases for composite-based cements for the kit according to the invention. As examples of such methacrylate derivatives, mention may be made of bisphenol A glycidyl methacrylate (bis-GMA), urethane dimethacrylate (UDMA), methyl methacrylate (MMA), bisphenol A ethyloxy-methacrylate (bis- EMA), ethylene-glycol-dimethacrylate (EGDMA), diethylene-glycol-dimethacrylate (DEGDMA), triethylene-glycol-dimethacrylate (TEGDMA), phosphoric acid methacrylate or a mixture thereof.

As regards the dispersed phase consisting of fillers, current composites contain a wide variety of filler particles varying in size, composition and percentage thereof. Now, and if it is possible to use organic fillers (eg resins) or organo-mineral fillers (organically modified ceramics), it is most often silica-based mineral fillers (in crystalline form (eg quartz ) or not (e.g. borro-silicate glass), or heavy metal glasses (barium, strontium, zirconium, yttrium or even ytterbium glass).These fillers are physically and chemically linked to the organic matrix and make it possible to ensure the mechanical and optical properties of the cement.As mechanical properties, these fillers make it possible to increase the resistance to compression, traction, bending and wear and also increase the radiopacity .

By silane is meant a bi-functional molecule possessing a mineralophilic pole and an organophilic pole. Such a molecule makes it possible to graft the polymer to the filler. By way of example of such functional molecules, mention may be made of methacryloxypropyl-trimethoxy-silane (MPMA) or acryloxypropyl-trimethoxy-silane (APM).

It is possible to choose between a dispersing phase and/or a dispersed phase functionalized by silanization.

Silanes are chemical compounds with the formula Si _n H _2n+2 , the simplest of which is the silane with the formula SiH ₄ which constitutes the siliceous structural analogue of methane

It is part of the family of hydrides composed of silicon and hydrogen, which can be seen as the silica analogues of alkanes.

As regards the dispersing phase, silane acrylates or methacrylates can be found.

With regard to the dispersed phase, we can find fillers that have undergone an industrial silanization treatment, we then speak of sizing.

According to another preferred embodiment, the adhesive substance is a cyanoacrylate.

Cyanoacrylates form a family of powerful and fast adhesives used in medicine, in industry, and in everyday life.

The cyanoacrylates that can be used in the context of the present invention include n -Butyl cyanoacrylate or enbucrilate (n-BCA, NBCA), isobutyl cyanoacrylate or bucrylate (ICA), Ethyl cyanoacrylate (ECA) and Octyl cyanoacrylate (OCA ).

Preferably, the cyanoacrylate used is NBCA or OCA.

In a particularly preferred manner, the cyanoacrylate used is NBCA, which is marketed in particular under the trademarks CUTSEAL, MEDIBOND, MEDICRYL, PERIACRYL, GLUSTITCH, XOIN, GESIKA, GLUEBRAN2, VETGLU, VETBOND, LIQUIVET, INDERMIL, LIQUIBAND, HISTOACRYL, IFABOND, etc. .

Finally, concerning the method of treatment according to the invention, this will require a minor surgical treatment.

Thus, this will require making a small incision in the gums under local anesthesia at the level of the mandibular or maxillary bones on which you want to glue the bonded device (1).

Similarly, it will be necessary after gluing the device (1) to make a suture so as to close the gum around the connection piece (4) of the implant (1).

The method according to the invention, in that it makes it possible to free the upper airways, is also intended to improve the ventilatory function of the subject.

The following examples are provided by way of illustration and do not limit the scope of the present invention.

EXAMPLES

1) Demonstration of the possibility of using plates bonded to a bone to treat type II and type III dysmorphoses.

For this test, bonded titanium devices in the form of a plate with a surface area of the order of 0.3 cm ² with a fixing element in the form of a hook were used as presented. in figure 1.

Fresh femur bones of bovine origin were chosen as bone support. Indeed, such supports are as close as possible to a moist jaw bone when exposed before attempting to bond the implant there without screwing. As part of the protocol used, each femur, after being dissected and cleaned, is placed in a base at one of its bases in FASTCAST Polyurethane AXSON F180 resin. Thus, each femur can be immobilized.

Different glues were then used to test the bonding of the device glued to the bone. During bonding, the subperiosteal membrane of the femur was detached beforehand and the bone was dried using compresses. The device then had to be positioned so that the hook was looking down. Among the different glues tested, we can mention:

Glue A: PALACOS R+G®

Glue B: HISTOACRYL®

Glue C: RELYX ^TM UNICEM 2 Automix

Glue D: OTOMIMIX®

The gluing of the devices (1) on a femur bone was then carried out by the same operator, scrupulously respecting the gluing protocol specific to each glue.

The femur bone comprising the bonded device to be tested is then positioned under a traction and compression machine corresponding to an MTS LANDMARK 370.1 axial hydraulic cylinder operated with MTS TestSuite™ Multipurpose Elite Software. This cylinder is equipped with an LVDT linear displacement sensor integrated into the cylinder (range ±80 mm), calibrated by an accredited body, with a resolution of 10-3mm and with a displacement measurement uncertainty of less than 0.23% on the full range (for k=2). It is also equipped with a Kistler 9317B tri-axial force sensor, calibrated by a notified body and whose linearity error on the force measurement is less than 0.09% over the range of use. The resolution of the force sensor is 5N. The acquisition is performed at a frequency of 1 kHz.

Cylinder calibration and data collection were carried out by 2 examiners simultaneously. In order to calibrate all the operators/examiners, the methodology was established in common and the measurements were collected individually.

Phase 1 of the protocol consisted in measuring the resistance of the adhesives under quasi-static loading. This test was carried out using a nylon thread which made it possible to create a connection between the hooks of the implant and the one installed on the axis of the actuator. The axis of traction was here also vertical, perpendicular to the horizontal axis of the implant. Once the actuator was activated, each implant was subjected to a linear, slow and progressive loading, at a rate of 1mm/s. The maximum force at break, i.e. the force for which the implant was separated from its support, was recorded for each test. This test was repeated 3 times per glue. The values were then averaged over the 3 trials.

Phase 2 of the protocol consisted in measuring the resistance in cyclic loading representing the mouth opening and closing movements. The sample was first placed on the cylinder. This test was performed using an orthopedic elastic (WHALE from ORMCO®, 6H (1/2’’), 14Oz) resting on the hook of the implant and that of the jack. The traction axis was perpendicular to the horizontal axis of the implant. Each implant was subjected to a sinusoidal cyclic loading ranging from 250g (maximum force applied in the clinic) to 750g (safety factor), with a period of 0.25s. In total, 10 min of loading were programmed, i.e. 2400 cycles. The maximum force at break was noted when reached. These tests were repeated 3 times.

Among the glues tested, the OTOMIMIX® glue (D) presented an adhesive rupture on its 6 implants even before placement in the actuator. Other glues, among which glues A, B and C have produced exploitable results both in quasi-static loading and in cyclic loading. Glue A had a breaking point on average at 9.6N with a standard deviation σ [7.2; 10.4], glue B at 22.1N with a standard deviation σ [19.6; 24.3], glue C at 25.2N with a standard deviation σ [15.7; 37.8]. These glues exhibited adhesive and non-cohesive failure. There did not appear to be any detached bone fragment to the naked eye during the adhesive rupture.

For phase 2 and unexpectedly, only adhesives B and C did not show a breaking point during the cyclic loading, i.e. 2400 cycles. For the other adhesives tested, they showed a breaking point during cyclic loading. Thus, glue A presented a breaking point during the cyclic loading at 82.9 s on average, i.e. at 331 cycles.

As a result, glues B and C could be used in the field of Orthopaedics-Dentofacial for forces up to 250g. Indeed, they allow to stick a metal device on the bone, which can then support up to 750g of traction force at least. Therefore, the combined use of non-screwed implants and their bonding with specific adhesives will have the advantage of being able to intercept class II and III skeletal dysmorphoses as early as possible and consequently prevent their aggravation, so as to obtain a purely skeletal action without dento-alveolar compensations. Finally, the treatment time will be reduced by acting at an early stage and a large number of orthognathic surgeries could thus be avoided.

2) Demonstration of the possibility of using devices (1) glued to a bone to treat type II and type III dysmorphoses:

A young boy or girl between the ages of 5 and 12 presents to the consultation with class II or III dysmorphosis or OSAS.

The indication of the operating protocol being accepted by the parents and the child, the intervention is then programmed. This is performed under local anesthesia: infiltration of vasoconstrictor, incision at the muco-gingival junction with or without vestibular partition, minimal groaning under the periosteum. Depending on the anatomy and the age of the patient, a connection piece (4) of suitable length is chosen. The plate with a surface area of 0.3 cm ² can be adapted as needed. Before gluing the plate, the site is dried so as to proceed with the “bloodless” gluing. Once the setting time of the glue is over, the resistance is checked then the incision is closed with 2 stitches of resorbable suture type Vicryl Rapide 4.0. Finally, the estimated operating time is around 10 minutes per site on average. The elastic traction can then be either immediate or deferred (8 to 10 days) and be carried out for a minimum period of 12 months with the possibility of keeping the device longer by folding the connection part and the fixing element under the vestibular mucosa for secondary reactivation.

For a good implementation of the protocol, controls are carried out every 6 to 8 weeks at the orthodontist.

Other potential applications with this system are planned:

- maxillary or mandibular osteosynthesis in children with temporary or mixed dentition,

- closure of cranial flaps and craniotomies in children,

- mandibular and/or maxillary fracture osteosynthesis by removing the connection elements,

- closure of sinusotomies, buccosinus communications (CBS), maxillary sinus graft and pre-implant ROGs (replacing membrane stabilization pins),

- dental traction for unitary dental retention or complex eruption disorder, control of intra-arch dental displacements in the 3 dimensions of space, stabilization of dental elements to increase anchorage,

• L’ingression d’une seule dent ou d’un groupe de dents
• Le redressement de molaires
• La distalisation des molaires
• La distalisation des canines
• Les mouvements en masse des arcades (par exemple dans la correction des occlusions asymétriques), pour rétablir la médiane des incisives maxillaires
• Dans les thérapeutiques de classe II d’angle avec extractions de prémolaires ou sans extractions de prémolaires en effectuant une distalisation en masse de l’arcade maxillaire
• Mise en place des dents retenues
• Lors d’un ancrage dentaire insuffisant

In conclusion, the bone anchoring device according to the invention may be indicated in all cases of treatment where mini-screws or screwed bone anchoring plates are used, such as in the correction of dental malocclusions. For example for:

• The intrusion of a single tooth or a group of teeth
• Straightening of molars
• Distalization of molars
• Distalization of the canines
• Mass movements of the arches (for example in the correction of asymmetrical occlusions), to restore the median of the maxillary incisors
• In angle class II therapies with extractions of premolars or without extractions of premolars by performing a mass distalization of the maxillary arch
• Placement of retained teeth
• In case of insufficient dental anchorage

Claims (10)

A system, which is advantageously intended for the treatment of class II or class III dysmorphoses, and/or OSAS, and which comprises:
i) – at least one elastic means (5), preferably at least one pair of elastic means (5), and
ii) at least one pair of devices (1), preferably at least two pairs of devices (1), each device (1) comprising:
a) a plate (2) to be attached to the maxillary or mandible bone of a subject;
b) a fixing element (3) for fixing the elastic means (5), which can for example take the form of a hook, a ball or a ring; And
c) a connecting piece (4) which connects the fixing element (3) to the plate (2), and which is adapted to extend through the gum which surrounds the corresponding bone;
Characterized in that the plate (2) does not include any recess intended to allow screws to pass to fix the device to the bone. The system according to claim 1, characterized in that the device (1) is made of any biocompatible and sufficiently resistant material such as titanium and its alloys, polyetheretherketone (PEEK), zirconia or even ceramic. The system according to claim 1 or 2, characterized in that the plate (2) has:
- a sufficient surface to allow its effective bonding to the bone of the mandible or to the bone of the maxilla, which surface is greater than or equal to 0.1 cm ² , preferably greater than or equal to 0.25 cm ² , and particularly preferably greater than or equal to 0.5 cm ² ;
- a rough surface intended to be bonded to the mandible bone or to the maxillary bone, which is chosen from the group comprising sandblasted, frosted, scratched, ridged and serrated surfaces
- a thickness of between 0.5 and 5 mm, preferably between 1 and 3 mm. The system according to any one of claims 1 to 3, characterized in that the connecting piece (4) takes the form of a rod and in that it is coaxial with the fixing element (3). The system according to any one of Claims 1 to 4, characterized in that the elastic means make it possible to apply a stress ranging from 0.05 to 20 N (newtons) between the two plates (2), preferably ranging from 0. 5 to 8 N and, particularly ranging from 1.5 to 6 N. The system according to any one of claims 1 to 5, characterized in that the elastic means (5) take the form of elastomeric rubber bands and in that the fixing element (3) takes the form of a hook , a ball, a ring or any other shape to ensure retention of the elastic means (5). A kit, which is advantageously intended for the treatment of type II or type III dysmorphoses, and/or OSAS, and which comprisesa) a system as defined in any one of claims 1 to 6, and characterized in that the plate (2) does not include any recess intended to allow screws to pass through to fix the device to the bone and in that the kit further comprises b) a packaging comprising an adhesive substance allowing the plate (2) to be fixed to the 'bone. The kit according to claim 7, characterized in that the adhesive substance is a composite-based cement which comprises a dispersed phase comprising a mineral, organo-mineral or organic filler coupled, by means of a silane, to a dispersing phase consisting into the organic matrix, which comprises at least one monomer derived from methacrylate. The kit according to claim 7, characterized in that the adhesive substance is a cyanoacrylate chosen from the group comprising n -Butyl cyanoacrylate or enbucrilate (n-BCA, NBCA), isobutyl cyanoacrylate or bucrylate (ICA), Ethyl cyanoacrylate (ECA) and Octyl cyanoacrylate (OCA); preferably NBCA or OCA A device as defined in any one of claims 1 to 6, which is advantageously intended for the treatment of class II or class III dysmorphoses and/or su OSAS, and which comprises:
a) a plate (2) to be fixed to the maxillary bone or the mandible bone of a subject;
b) a fixing element (3) for fixing an elastic means (5), which preferably takes the form of a hook, a ball or a ring; And
c) a connection piece (4) which connects the fixing element (3) to the plate (2), and which is adapted to extend through the gum which surrounds the corresponding bone;
Characterized in that the plate (2) does not include any recess intended to allow screws to pass to fix the implant to the bone.