NASAL ORTHOPAEDIC DEVICE

DESCRIPTION

Field of the Invention

The present invention refers to an orthopaedic device for nasal use.

Background

To date, on the market there are various devices to be applied to the nose in defence of its anatomical integrity - the so-called orthoses - which are used above all, if not solely, in post-traumatic events or during activities exposing to trauma risks (e.g., sports activities such as soccer, basket, boxing, etc.)

Moreover, there are various nose-resting devices for eyeglasses - the so-called nose pads - with the aim of improving the aesthetics and/or the comfort of the latter.

A last typology of nasal device has the aim of facilitating the breathing by forcedly dilating the nostrils - i.e., the so-called nasal strips.

Some examples of known devices are briefly described hereinafter.

US 3,835,848 describes an orthopaedic aid for modelling the nose following traumatic events. Said device comprises a surgical splint shaped according to the desired anatomy and applied in correspondence of the central bridge of an eyeglasses frame-shaped structure. The latter is equipped with side goggles and an elastic band for holding it on the head.

FR 516 288 instead describes a device for modifying, for aesthetical reasons, a nose shape. Said device is composed of a shaped body reproducing the desired shape for the nose, on which shaped body a metallic reinforcement member is applied. The shaped body is held in position on the head by a plurality of elastic bands.

Finally, JP 2001305489 describes a nose pad for glasses contrived in order not - -

to exert burden on the nose. Said nose pad is composed of two lateral struts and a central bridge made of a material deforming along the shape of the nose when pressed to the latter.

However, the conditioning or remodelling orthopaedic devices known in the art generally do not achieve an optimal compromise between effectiveness of stress exerted on the nose and comfort of the subject wearing it.

Summary of the Invention

Therefore, the technical problem set and solved by the present invention is that of providing a nasal orthopaedic device destined for - and capable of - favourably conditioning the growth of the nasal pyramid during the age of development and inducing a remodelling thereof in the adult, which device be highly effective yet also comfortable to wear.

Such a problem is solved by an orthopaedic device according to claim 1 .

Preferred features of the present invention are set forth in the dependent claims thereof.

The present invention provides several relevant advantages. The main advantage lies in the fact that the proposed orthopaedic device solves the above-mentioned technical problem by a simple, yet concomitantly highly effective structure, capable of applying stresses optimal to the ends of said growth or modelling and having extremely reliable in situ holding modes.

Moreover, the proposed device is susceptible of easy and low-cost manufacturing.

These advantages are obtained in particular by a wire-shaped elastic pressure member, which is positioned on the nasal pyramid to be modelled and is shapeable according to the specific anatomy desired. Said elastic pressure member is apt just to exert directly on the nose a conditioning/remodelling - -

elastic force. Preferably, said pressure member has a spring-like structure, even more preferably carrying a plurality of loops and/or convolutions or coils.

Other advantages, features and operation steps of the present invention will be made apparent in the following detailed description of some embodiments thereof, given by way of example and not for limitative purposes. Reference will be made to the figures of the annexed drawings.

Brief description of the drawings " Figures 1A and 1 B show a partially exploded perspective view, respectively front and rear, of a first preferred embodiment of the orthopaedic device according to the present invention;

^■ Figures 2A and 2B show a perspective view, respectively front and rear, of the device of Figure 1A in an assembled configuration ready for customization to a patient;

■ Figures 3, 4 and 5 show each an enlarged perspective view of a respective detail of the device as depicted in Figure 2B;

^■ Figure 6 shows a perspective view of the device of Figure 1A in a configuration of application on a patient; " Figures 7A and 7B show a perspective view, respectively front and rear, of a second preferred embodiment of the orthopaedic device according to the present invention; and

■ Figure 8 shows a perspective view of the device of Figure 7A in a configuration of application on a patient.

Detailed description

Theoretical bases

Before turning to the detailed description of the embodiments depicted in the . .

figures introduced above, an illustration of the anatomical and physiological bases underlying the invention will be useful. To this end, it has to be noted that the anatomy and physiology of the child and of the adult are profoundly different. In particular, potentials for growth and development are still present in the child, by "growth" meaning an increase in size and an anatomic modification, and by "development" an increase of the anatomo-functional specialization of the subject. The orthopaedic device of the invention is mainly meant as an aid apt to condition a correct growth of the nasal pyramid or induce a remodelling of the latter, by acting with predetermined elastic forces on growth sites predisposed for this purpose, i.e. on zones already genetically predisposed to grow, yet without interfering with the ordinary physiological development of the nasal functions (e.g., the patency and caliber of the nasal cavities).

In the jaw, which is the bone addressed by the Inventor, the growth sites are located in specific zones, positioned roughly in the areas of joint between the various bone portions, and therefore between the two maxillary bones, between the latter and the nasal bones and between the maxillary bones and the cranial bones. These sites are subject to three types of growth (and of development), i.e.: - the so-called primary repositioning, i.e. the expansion peculiar to the bone at issue found on the growth sites,

- the so-called secondary repositioning, i.e. the expansion of neighbouring anatomical portions and the consequent migration of the bone portion at issue, and - the so-called remodelling, i.e. the resorption/growth in "every" zone of the bone.

The invention stems from the observation that said growth processes are partly intrinsic and genetically conditioned, and partly conditionable by suitable mechanical stresses exerted on the above-mentioned areas. Moreover, the invention stems from the observation that such stresses must be exerted during specific periods of the subject's life, when there is potential for growth and when said potential is exerted on bones that are to be conditioned.

In the adult instead the situation is quite different, as there is no residual potential for growth, and therefore emphasis has to be laid on only one of the three above-mentioned processes, i.e., on the remodelling.

Moreover, it has to be noted that in order to perform the conditioning function set forth hereto reference has to be made to biological bases answering some questions, specifically:

(i) Can a bone formation be conditioned? (ii) If yes, in what way?

(iii) If yes, in which age group?

(iv) Such a conditioning of the growth may be harmonious or only tumultuous and random?

The first question is answered by the functional matrix theory, according to which: a) genetic and epigenetic variants of skeletal development lie in the functional matrix of soft tissues around the bone; b) bone behaviour is merely passive; and c) a selection of genetic origin modulates the quality and quantity of expression of certain characters.

The second question is answered instead by a careful reading of the human anatomy. In fact, bone shape is due to various components, specifically genetics, mechanical stimulations and any intercurring pathologies. Therefore, bone shape is the result of a dynamic process acted on and conditioned by several factors external thereto.

As to the third question, Wolffs law asserts that bone morphology is progressively structured in accordance to the sum of all variable mechanical forces exerted thereon, in the course of the process of growth and development - -

and, to a lesser extent, once growth has ended.

The best age for obtaining the growth conditioning at the basis of the invention is the pubertal growth peak, in which there is already a high potential for growth and in which the right conditioning can yield great results. In the adult age, instead, conditioning can only occur via remodelling (resorption/apposition) and modifications can only be of limited extent, though even very satisfactory under an aesthetical standpoint, e.g. in case of correction of the nasal gibbus.

The fourth question investigates the harmony (or absence of harmony) of growth conditioning. It is answered by the so-called counterpart principle, according to which the growth of any facial and/or cranial zone is linked to and conditions the growth of the structural or geometric counterparts of the face and cranium: what ensues is a mutual balanced growth. In other words, if the stimulation is harmonious the ensuing modifications are harmonious as well, even if such modifications have to concomitantly involve plural bones.

Description of preferred embodiments

Referring initially to Figures 1A, 1 B and 2A, 2B, an orthopaedic device according to a preferred embodiment of the invention is generally denoted by 1.

The device 1 is apt to condition the growth of the nasal pyramid of the subject wearing it, or, in the adult, to remodel the nasal pyramid itself. To this end, the device 1 mainly comprises an elastic pressure member 2 having a wire-shaped development, connected or connectible to a structure 3 substantially shaped like an eyeglasses frame. The latter is preferably without nose pads and held on the subject's head by a flexible elongated member, or string, 4 apt to circumscribe the head.

As will be made evident in greater detail hereinafter, the overall arrangement is such that the pressure member 2, in use, exerts a growth conditioning/ remodelling elastic stress of a predetermined extent on the nasal pyramid.

Further delving into the detail of each of the above-introduced components, as . .

mentioned the pressure member 2 is apt to be arranged onto the nasal pyramid and is shaped or shapeable according to the anatomy to be given to the latter.

In Figures 1A to 3, the member 2 is depicted in an undeformed configuration. As shown in Figure 6, in use the pressure member 2 is deformed just to assume said conditioning/remodelling configuration, which is a curved configuration with a concavity facing the nasal pyramid. The deforming of the member 2 can be carried out according to modes usually applied for the deforming of known orthodontic wires, and in particular with specific pliers or turrets of predetermined shape. In the present case, suitable for the purpose is a template having the shape of an "ideal nose", capable of imparting the desired shape to the member 2 by pressure.

As best seen in Figure 3, in the present embodiment the pressure member 2 has the above-mentioned wire-shaped development and is equipped with a plurality of loops 201 defining a plurality of convolutions or coils 20 interposed between two side arms 21 and 22. Overall, the loops 201 and the convolutions or coils 20 define a substantially spring-like elastic central structure. In the use configuration described herein, therefore with the central spring-like structure deformed according to the anatomy desired for the nasal pyramid, the pressure member 2 is apt to exert said conditioning/modelling elastic stress on the nasal pyramid.

The rigidity peculiar to the pressure member 2 and in particular to the convolutions or coils 20 thereof - and consequently the extent of transmission of elastic forces to the nose - may be selected according to specific therapeutic needs, and optionally modified during the treatment by a modification of the configuration of said member or by a modification of the section and/or material with which the spring is made.

The side arms 21 and 22 - or extensions thereof - allow connection of the pressure member 2 to the structure 3.

Moreover, the side arms 21 and 22 enable to position the spring-like elastic central structure - i.e. the active portion of the member 2 - at a desired level on the nose. _ _

Preferably, the arms 21 and 22 have a telescopic structure, thereby enabling adjustment of the device on patients with any nose shape.

The pressure member 2 may be made of TMA (Titanium-Molybdenum) wire or of different materials, like, e.g., Nickel-Titanium, a polymer or steel. Moreover, the arms 21 and 22 and/or their extensions and/or the spring-like central structure may be coated of polyvinyl or soft silicone material, to prevent formation of decubitus and/or abrasions on the skin, in the point of application of the forces.

As mentioned above, the pressure member 2 allows a modulation of the elastic forces applied to the nose even by a modification of its configuration, and in particular of the configuration of the spring-like structure.

The frame-shaped structure 3 and the corresponding elongated member 4 define holding means for holding the pressure member 2 onto the nasal pyramid, allowing the latter to exert on the nasal pyramid itself said conditioning/remodelling stress.

The frame-shaped structure 3 comprises, like the conventional frames, two rims, respectively 31 and 32, apt to circumscribe the orbital seats, and a bridge 33 interposed between the rims themselves.

As best seen in Figure 3, each of the arms 21 and 22 of the pressure member 2 - or a suitable extension of said arm 21 , 22 - is connected or connectible to the structure 3 in correspondence of a respective medial portion of the latter immediately adjacent to a respective end of the bridge 33, i.e. substantially in correspondence of the frame portion usually housing a so-called nose pad. In correspondence of such medial portions of the structure 3 suitable tubular seats, respectively denoted by 301 and 302, are provided for said side arms 21 and 22 or for the extensions thereof.

Said tubular seats 301 and 302 may have a length each equal to about 1 cm, with a through hole having a rectangular perimeter and, e.g., a (0.18 x 0.25) size. The orientation of the seats 301 and 302 is substantially perpendicular to the bridge 33 and the seats are substantially parallel therebetween. . .

As to the flexible member, or string, 4, this is preferably elastic.

Moreover, as best seen in Figure 5, preferably the flexible member 4 carries means 5 for adjusting the level of traction exerted by the pressure member 2.

As best seen in Figure 4, the flexible member 4 is connected to the frames- shaped structure 3 in correspondence of side seats thereof. In particular, the longitudinal ends of the flexible member 4 are made integral each to a respective connecting flange 41 , which in turn is connected, preferably by a bayonet-type retaining mechanism, with a respective connecting flange 43 integral to the frame-shaped structure 3. According to a variant embodiment particularly suitable for use in the adult age, the frame-shaped structure 3 may provide, instead of the flexible member 4, a pair of side arms similar to those in use for conventional eyeglasses, preferably having curl-type enveloping retroauricular ends, to fully engage the back of a respective ear and thereby ensure a certain and reliable holding of the pressure member 2 on the nasal pyramid, accurately stabilizing the eyeglass and therefore exerting the orthopaedic forces in a controlled manner. In this embodiment as well, the connecting modes between side arms and frame- shaped structure may be analogous to those introduced above in the case of the flexible elongated member 4. According to a further variant embodiment, there may be provided side arms having a substantially rectilinear development, jointed rearwise by a flexible member carrying said adjusting means.

Turning now to Figures 1A and 1 B, preferably the device 1 further comprises a pair of weight members, respectively denoted by 61 and 62, selectively applicable each in correspondence of a respective portion of frame-shaped structure 3 corresponding to the superior orbital arches. The weight members 61 and 62 may be selected so as to modify, and in particular calibrate in connection to a specific subject and/or to the evolution of the treatment of the respective nasal pyramid, the extent of said conditioning/remodelling stress. In fact, the pressure exerted by the pressure member 2 onto the nasal pyramid varies according to the weight of said members. - -

In the present example, the weight members 61 and 62 are in the form of shaped segments substantially reproducing the configuration of the frame portion to which they are applied. Moreover, the weight members 61 and 62 are removably connective to the latter by a reversible coupling between pins 50 and respective seats 30 on the frame-shaped structure 3.

The applying of weight members is particularly indicated for the treatment of adult subjects.

The embodiment and related variants of the device of the invention described hereto are particularly suitable for use of the device 1 as daytime orthopaedic aid.

According to another embodiment of the invention, the device can also be construed for night-time use. An exemplary embodiment of a device for this second type of application is shown in Figures 7A, 7B and 8.

Such second embodiment of the device, in this case generally denoted by 100, envisages an elastic pressure member analogous to that introduced above with reference to the first embodiment and here denoted by 200. In this case, the pressure member 200 is provided always in a configuration deformed according to the anatomy to be given to the nasal pyramid.

Moreover, the pressure member 200 is associated to a shaped body 300, preferably flexible and made, e.g., of silicone, substantially reproducing the shape of the nasal pyramid.

Said shaped body 300 may be made of hard elastic materials (e.g., Teflon, polyvinyl, etc.) so as not to cause decubitus.

The shaped body 300 and the pressure member 200 integral to - and generally embedded in - it are held on the subject's head by a plurality of elongated flexible members circumscribing the head itself and coupled to the shaped body 300. In the present example three of said members, respectively denoted by 401 , 402 and 403 are effectively provided and respectively arranged at a top vertex of the shaped body 300 which corresponds to the apex of the nasal pyramid, at an intermediate portion of the shaped body 300 and at a bottom - -

portion of the latter corresponding to the base of the nose itself.

Preferably, the elongated members 401-403 are elastic and provide means for adjusting the level of traction exerted by the pressure member 200, means that is analogous to that introduced with reference to the first embodiment.

5 Such members 401-403 may be made of inert and anallergic silicone material.

It will be appreciated that the provision of a night-time device allows an effective continuity in the applying of the conditioning/remodelling stress and consequently a better therapeutic result. The device for night-time use carries on what is begun by daytime devices and completes their function. o

The present invention has hereto been described with reference to preferred embodiments thereof. It is understood that other embodiments might exist, all falling within the concept of the same invention, as defined by the protective scope of the claims hereinafter.