WO2009062541A1

WO2009062541A1 - Mandibular advancement orthosis

Info

Publication number: WO2009062541A1
Application number: PCT/EP2007/062233
Authority: WO
Inventors: Georges Magnin; Jacques Magnin
Original assignee: Oscimed Sa
Priority date: 2007-11-12
Filing date: 2007-11-12
Publication date: 2009-05-22

Abstract

The invention relates to a mandibular advancement orthosis that comprises a unitary flexible member (30) that can be folded on itself for interaction with the teeth of the upper and lower arches (90), and an interchangeable flexible strip (70) for surrounding the teeth of the upper arch, having a length that can be modified in order to obtain the desired level of mandibular advancement.

Description

Mandibular advancement orthosis

Technical area

The present invention relates to the field of oral orthosis, and in particular to an orthosis for the treatment of snoring and nocturnal apnea.

State of the art

Snoring is a well-known sound manifestation whose anatomical and physiological causes are related to muscle hypotonia that appears during sleep. Indeed the mandible, normally maintained by the action of the muscles, tends to retreat during sleep, causing in its movement the tongue towards the back of the mouth and thus causing a decrease in the caliber of the upper airways. The resultant turbulence of the respiratory flow, amplified by vibrational and resonant phenomena of the soft palate and adjacent soft tissues, is responsible for the humming noise that can, in some cases, reach an extremely high intensity.

Snoring is not limited to discomfort, even severe, the quality of sleep of pets and relatives of the person affected. Sometimes, and particularly in individuals with small macroglossia or oral cavity, or if tissue laxity is high, obstruction of the breathing channel may be severe or complete, resulting in interruptions in breathing, or obstructive sleep apnea.

In this case, snoring is an aspect of a true pathology that is also manifested by the fragmentation of sleep leading to daytime sleepiness and a decline in concentration capabilities. Apnea causes hypoxia, bradycardia followed by tachycardia with hypertensive risks. This apnea is likely to trigger a nocturnal cardio-respiratory arrest.

Numerous devices have been proposed to combat snoring including intraoral devices clinging to the upper and lower dental arches, to propel and immobilize anterior mandible even in the absence of sufficient muscle tension . The disadvantage of the immobilization of the mandible is the inconvenience caused to the wearer. Indeed, the lack of freedom of movement of the jaw can result in muscle tension, friction in the gums, lateral forces on the teeth etc. so that improvements have been required to improve the oral comfort of wearing such devices.

Patent EP0845962 describes for example a thermoformable articulated device combining flexible elements and semi-rigid elements allowing some freedom of movement of the mandible while propelling it forward. This device consists of two shells made of a thermoformable material. In this way, each patient can adapt the hulls to his own conformation by heating them in a water bath heated to a temperature sufficient to soften the thermoformable layer, and then molding them on the corresponding arch.

Nevertheless, a limitation of such a device allowing a certain freedom of movement of the mandible is that the latter may, as a result of involuntary movements in sleep, abandon the propelled position forward. The device then loses all its effectiveness. In these cases, the freedom of retropropulsion paradoxically goes against the goal sought, the mandibular advancement.

Improvements have been proposed for the sake of efficiency, to keep the anti-snoring device in position despite movements of the jaw. The patent WO95 / 14449 describes for example an articulated device of two thermoformable aligners which keep the mandible in an advanced position even in the case of movements of the jaw in the sagittal plane, for example when opening and closing the mouth. The joint generates forces that plumb the respective aligners on the lower and upper dental arches. This device does not allow to vary the mandibular advancement.

Furthermore, the conformation of the teeth and dental arches can vary enormously from one individual to another, either because the arches can be more or less wide in each individual, or because the teeth are not regular. positioned along each arcade. The realization of custom orthotics manufactured as single pieces from the impressions of the maxillary and the mandible of the wearer by conventional methods in the field of orthodontics are obviously possible; however, it is readily understood that the manufacturing cost of this type of personalized device is significantly higher than that of a customizable orthosis manufactured in series. This is the reason why other devices have been proposed to overcome the very limited adaptability of thermoformed devices that can not cover the entire spectrum of possible conformations a priori.

Patent WO055117776 of the same applicant describes for example a mandibular advancement orthosis comprising shells composed of articulated frames, allowing better adaptation to various dental configurations.

Despite all the improvements made to anti-snoring devices, the known devices still do not adapt propulsion maintenance to certain static physiological constraints, such as the position of the wearer during sleep, and dynamic movements of the jaw . It is for example frequent that the mandible abandons the position propelled forward when the head is positioned on the side, and similarly, after certain phases of the sleep characterized by a very important activity and a muscular tone, that the mandible is automatically postponed in the position therapeutic powered. The known solutions of the prior art have moreover shown that improving the efficiency of anti-scouring devices often goes against comfort for the wearer.

Another limitation of known devices is the higher cost of known adaptable customizable orthotics.

Brief summary of the invention

An object of the present invention is to provide a mandibular advancement orthosis free from the disadvantages of the prior art.

An object of the present invention is to provide an orthosis adapting to the physiological movements of the wearer while ensuring the effectiveness of maintenance. In particular, an object of the present invention is to simultaneously offer good dynamic support and comfort of optimal range.

Another object of the present invention is to provide an intraoral device against snoring that can accommodate a very large portion of individual user conformations and having good stability for any type of dental conformation of the wearer .

Another object of the present invention is to provide an orthosis with a variable adjustment with indexing of the mandibular advancement.

An object of the present invention is to provide a mandibular advancement orthosis of comfort and effectiveness equivalent to those of a custom orthosis but at a reduced manufacturing cost.

These objects are achieved by the products and the method which are the subject of the independent claims of the corresponding categories, the dependent claims relating to optional features of the invention. In particular, these objects are achieved by a mandibular advancement orthosis comprising a monoblock element comprising a first portion intended to fit at least partially to the lower dental arch of the wearer's oral cavity and a second portion intended to at least partially adapting to the upper dental arch of the wearer's oral cavity, the one-piece element having at least one hinge section enabling it to assume a folded configuration within the oral cavity, wherein said folded configuration portions are juxtaposed to the upper and lower dental arches respectively, said hinge exerting in the folded position the holding forces of said portions on said upper and lower dental arches respectively, and simultaneously a propulsive force on said first portion for advancing the lower mandible, the orthosis further comprising flexible strip connected to the monobloc element forming an arc that bears at least a portion of the teeth of the upper dental arch.

Brief description of the figures

Examples of implementation of the invention are indicated in the description illustrated by the appended figures in which:

FIGS. 1a, 1b and 1c illustrate, according to different views, a monobloc element of the orthosis according to the invention.

Figures 2a and 2b show the one-piece element of the orthosis three-dimensionally.

Figures 3a and 3b illustrate the orthosis of the invention comprising a monobloc element and a flexible tongue. Figure 4 is a three-dimensional representation of the orthosis of Figures 3a and 3b.

Figure 4b illustrates some geometric features of the orthosis corresponding to aspects of the invention.

Figure 5 shows a set of interchangeable strips according to one aspect of the invention.

Figure 6 shows the orthosis of the invention in folded configuration and, very simply, its relationship with elements of the oral cavity.

Figures 7a and 7b illustrate another example of the present invention.

Example (s) of embodiment of the invention

According to one aspect of the present invention, illustrated with reference to Figures 1a-1c, the mandibular advancement orthosis comprises a monoblock element 30, in which are formed two portions 51, 52 whose shape is intended to to adapt, at least partially, to the upper and lower dental arches of the oral cavity. The surfaces of the portions 51 and 52 are designed so that they can easily be adapted, thanks to their shape and to the elasticity of the material of which they are made, to different oral conformations. In particular, the inner side of the first portion 51 is intended to press the lingual surface of the teeth, and in particular the incisors, of the lower arch, and its shape is therefore studied accordingly. The labial side of the lower incisors does not receive the force of propulsion and, preferably, it is not covered by the first portion of the orthosis, for reasons of aesthetics and comfort. The monobloc element 30 is preferably made by injecting biocompatible plastic material and flexible, such as polyurethane-based resins. Optionally, the monobloc element could be obtained by overmoulding and incorporate components of different materials, for example a flexible internal armature and use flexible outer layer, optionally thermoformable.

The one-piece element 30 comprises, according to one aspect of the invention, a foldable and flexible section 53 forming a hinge allowing it to assume a folded configuration inside the oral cavity, as can be seen on the In the folded configuration the portions 51 and 52 are juxtaposed to the upper dental arches, respectively lower, while the flat surfaces 41 and 42, visible in the lay figures and 2a-2b are folded one on the other. The material of the one-piece member and the thickness of the hinge 53 are chosen so as to create an elastic member, giving elasticity to the hinge 53 and exerting an elastic force tending to open the orthosis. In the folded position, the elasticity of the hinge 53 contributes to push the two portions 51, 52 against the upper and lower dental arches, and hold them in position. Simultaneously the orthosis exerts a propulsive force on the first portion to advance the lower mandible.

In a variant not shown of the present invention, the elastic force tending to open the orthosis is due in whole or in part a heterogeneous elastic element, reported, fixed or inserted in the monobloc element 30, made of a material different from this one. The elastic member could comprise, for example, one or more resilient spring blades in correspondence of the hinge 53, or elastic elements of different shape. Depending on the circumstances, the elastic element may be metallic, for example steel, made of a polymer having good characteristics of elasticity and creep resistance, for example Delrin® or poly-acetal, or in a composite material, by a composite containing carbon fibers, the elastic element could be combined with the element 30 by any suitable method, for example example glued, inserted, chased or, preferably, included in the monobloc element 30 by overmoulding.

According to another aspect of the invention, shown in Figures 3a, 3b, 4a, 4b, the orthosis of the invention comprises a flexible strip 70 connected to the one-piece element. Examples of such strips are shown on a larger scale in Figure 5. In the example shown the connection is made through the buttons 60 provided for this purpose in the second portion 51 of the monobloc element, which cooperate with the holes 72 strips. Preferably the holes 70 have a slightly oval shape, to facilitate the insertion of the heads of the buttons 60. The buttons 60 and the holes 72 could also be replaced by other devices, cooperating with each other, able to connect the element monobloc 30 and the flexible strip 70, preferably detachably.

The flexible strip 70, connected at both ends to the two sides of the second element 52, which is intended to interact with the upper dental arch, forms an arc surrounding the upper dental arch, when the orthosis is worn, in contact with the lingual faces of at least a portion of the teeth of the upper arch, especially with the incisors and the canines, The flexibility of the strip allows it to marry the shape and curvature of the arch.

In addition to the first arc mentioned above, developing approximately in the plane of occlusion and corresponding to the physiological curvature of the upper dental arch, the strip 70 preferably comprises a second curvature, with a second arc, orthogonal to the first, indicated by the radius R2 in Figure 4b and correspond to the physiological curvature of the labial faces of the teeth of the upper arch.

The flexibility of the strip material allows at least partial adaptation of these curvatures to the individual buccal conformations of the carriers a certain adaptation to the individual conformational variations of the carriers. Preferably, the fasteners 60 of the strip 70 on the monoblock element 30 are arranged to form an angle α between the strip 70 and the occlusal plane. Tests have shown that an angle of approximately 15 ° provides better comfort and improves the stability of the orthosis.

The degree of advancement of the orthosis can be varied by changing the length of the strip 70, and thus the arc enveloping the upper arch. To this end, the orthosis of the invention is accompanied by an assortment of interchangeable strips of different length preferably with characteristics to differentiate them, for example a length mark 75, or a mark of color, or any another suitable index. According to another preferred aspect of the invention, the strips also have a median mark 77, helping the correct alignment of the orthosis in the mouth.

According to a not shown variant of the invention, the flexible strip 70 is permanently connected to the one-piece element 30 at one of its two ends, when the other end of the strip is connected to the one-piece element. 30 by adjustable connection elements, for example buttons 60 on the element 30, as visible in Figure 1b, and a series of holes on the strip 70 engageable with the buttons 60, which can determine different dimensions of the arc formed by the strip 70 and, therefore, the degree and strength of the desired mandibular advancement. Other forms of adjustable fasteners are also possible.

According to another aspect of the invention, visible in Figure 6, the one-piece element 30 comprises a curved bearing surface 55 for pressing on the lingual surface of at least a portion of the lower teeth 90 and transmit at least a portion of the propulsive force in the mandible. The oblique shape makes it possible to adapt to a greater variety of individual conformations, without pressing on the gingiva and, at the same time, to distribute the force of propulsion between a number important points of contact, on different teeth. Preferably this curved bearing surface 55 is made with a thin thickness, in order to obtain an optimal flexibility and a better comfort. The profile of the surface 55 is studied having regard to the natural profile of the teeth 90, and in particular the lower incisors, so that the contact force 59 is offset downwardly with respect to the occlusion plane, and inclined downwards. This orientation of the force 59 avoids movement of the teeth and improves the stability and effectiveness of the orthosis.

The surface 55 comprises two flexible safety tabs 57, visible in Figures 1a and 2a. These tabs serve to prevent the orthosis from passing over the lower teeth 90 (Figure 6) during involuntary movement in sleep. The anterior face of the safety tabs 57 is inclined downwards, thus allowing spontaneous repositioning of the orthosis in its normal position (as shown in FIG. 6) when the mandible regains its normal position and tonicity.

The orthosis of the invention, while having a particularly simple and economical construction, can adapt to a very large number of different oral conformations, thanks to the interchangeable strip 70 and the flexible construction and respectful of the body. 'anatomy. In this way the orthosis of the invention combines excellent comfort and good efficiency in the suppression of snoring.

Figures 7a and 7b shows a variant of the invention comprising the retaining members 102 and 103 on the first portion 51 and respectively on the second portion 52 of the element 30, intended to oppose the force elastic opening of the hinge 53 in the closed position. In the example shown, the retaining members 102 and 103 comprise on the one hand a hook and on the other a tooth, but it is clear that they could also assume different shapes, depending on the circumstances and the necessities. In physiological sleep the motor musculature undergoes phases of involuntary relaxation, alternated with phases of activity. The retaining members 103 and 103 hook slightly between them, to prevent unintentional opening of the mouth, and thus the abandonment of the desired propelled position in the release phases. A slight movement of the mouth is sufficient to unhook the retaining members and release the elastic hinge 53.

Claims

claims

A mandibular advancement orthosis comprising a one-piece element (30) having a first portion (51) adapted to at least partially fit the lower dental arch of the wearer's oral cavity and a second portion (52) for at least partially adapting to the upper dental arch of the wearer's oral cavity, the one-piece element (30) having at least one hinge section (53) enabling it to assume a folded configuration within the oral cavity, in which folded configuration said portions (51, 52) are juxtaposed to the upper and lower dental arches respectively, said hinge (53) exerting in the folded position holding forces of said portions (51, 52) on said upper dental arches and lower respectively, and simultaneously a propulsive force on said first portion (51) for advancing the lower mandible, the orthosis comprising in addition a flexible strip (70), connected to the one-piece element (30) forming an arc which bears at least a portion of the teeth of the upper dental arch.

2. mandibular advancement orthosis according to the preceding claim, wherein said holding forces are formed by an elastic member of said hinge.

Mandibular advancement orthosis according to one of the preceding claims, wherein at least one end of said strip (70) is detachably connected to said second portion (52) of the one-piece member (30).

4. mandibular advancement orthosis according to the preceding claim, combined with an assortment of interchangeable strips (70) of different lengths, the choice of the strip (70) attached to the one-piece element (30) determining the degree and the force of the desired mandibular advancement.

A mandibular advancement orthosis according to claim 3, wherein one end of said strip (70) is connected to said second portion (52) of the one-piece member (30) by adjustable connecting means included in said strip ( 70) and in said one-piece member (30), so as to determine the degree and force of the desired mandibular advancement.

The mandibular advancement orthosis according to one of the preceding claims, wherein the strip (70) has a double curvature, with a first arc developing approximately in the occlusal plane and corresponding to the physiological curvature of the upper dental arch. , and a second radius of curvature (R2) correspond to the physiological curvature of the labial faces of the teeth of the upper arch.

7. mandibular advancement orthosis according to the preceding claim, wherein the flexibility of the strip (70) allows at least partial adaptation of said curvatures to the individual oral conformations of the carriers.

8. mandibular advancement orthosis according to one of the preceding claims, wherein the strip (70), when attached to the one-piece element (30), forms therewith an angle (α).

The mandibular advancement orthosis according to one of the preceding claims, wherein the strip (70) has centering marks (77) for simplifying the alignment of the orthosis in the oral cavity, and / or marks of length (75) to indicate the degree of mandibular advancement obtained when the strip is attached to the one-piece member (30).

Mandibular advancement orthosis according to one of the preceding claims, comprising on the one-piece element (30) a bearing surface. oblique (55) intended to come into contact with the lingual surface of the lower teeth and transmit at least a portion of the propulsive force.

The mandibular advancement orthosis of claim 2, comprising at least one elastic member in a material different from the one-piece member (30).

12. Mandibular advancement orthosis according to the preceding claim, wherein said elastic element comprises a blade of elastic material included in the monobloc element (30) by overmoulding.

13. mandibular advancement orthosis according to one of the preceding claims, comprising retaining members (102,103), opposing the elastic force opening the hinge (53) in the closed position.