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Publication numberWO2013190580 A1
Publication typeApplication
Application numberPCT/IT2012/000190
Publication date27 Dec 2013
Filing date21 Jun 2012
Priority date21 Jun 2012
Publication numberPCT/2012/190, PCT/IT/12/000190, PCT/IT/12/00190, PCT/IT/2012/000190, PCT/IT/2012/00190, PCT/IT12/000190, PCT/IT12/00190, PCT/IT12000190, PCT/IT1200190, PCT/IT2012/000190, PCT/IT2012/00190, PCT/IT2012000190, PCT/IT201200190, WO 2013/190580 A1, WO 2013190580 A1, WO 2013190580A1, WO-A1-2013190580, WO2013/190580A1, WO2013190580 A1, WO2013190580A1
InventorsPasquale Umberto MARTINO
ApplicantBalsport Solutions S.L.
Export CitationBiBTeX, EndNote, RefMan
External Links: Patentscope, Espacenet
Method for manufacturing dental devices, and dental device
WO 2013190580 A1
Abstract
A method for manufacturing a dental device, which consists in: preparing, in a step a., a mandible model (2) and a maxilla model (3) of a patient, intended to receive the device (1); storing, in a step b., a predefined dental occlusion for the models (2, 3), which corresponds to a specific closure mode of the dental arches of the patient, and to a preset occlusal key (4); performing, in a step c, a thermoforming treatment on a sheet (5) that is at least partially thermoformable and substantially faces one of the models (2, 3) for mating with it and producing a first portion (6) of a dental device (1), which has a first surface region that is substantially complementary to the shape of the model (2, 3); working manually, in a step d., a first pliable substance which is inserted between the first portion (6), which is mated with the model (2, 3), and the other model (2, 3), mutually arranged according to the predefined dental occlusion, to close completely the gaps comprised between the models (2, 3), with the first portion (6) mated, and consequently modeling a second portion of the device (1), obtaining a complete dental device (1), which can be clamped between the maxilla and the mandible of a patient according to the predefined dental occlusion and has a second surface region, which is opposite the first surface region and is substantially complementary to the shape of the other model (2, 3).
Claims  (OCR text may contain errors)
1. A method for manufacturing a dental device, which consists in: a. preparing a mandible model (2) and a maxilla model (3) of a patient, intended to receive the device (1);
b. storing a predefmed dental occlusion for said models (2, 3), which corresponds to a specific closure mode of the dental arches of the patient, and to a preset occlusal key (4);
c. performing a thermoforming treatment on a sheet (5) that is at least partially thermoformable and substantially faces one of said models (2, 3) for mating with said one of said models (2, 3) and producing a first portion (6) of a dental device (1 ), which has a first surface region that is substantially complementary to the shape of said one of said models (2, 3); d. working manually a first pliable substance which is inserted between said first portion (6), which is mated with said one of said models (2, 3), and the other one of said models (2, 3), mutually arranged according to said predefmed dental occlusion, for the complete closure of the gaps comprised between said models (2, 3), with said first portion (6) mated, with consequent modeling of a second portion of the device (1) and obtainment of a complete dental device (1), which can be clamped between the maxilla and the mandible of a patient according to said predefined dental occlusion and has a second surface region, which is opposite said first surface region and is substantially complementary to the shape of said other model between said mandible model (2) and said maxilla model (3).
2. The method according to claim 1, characterized in that it provides, prior to said preparation step a., for
el . determining said predefined dental occlusion, which corresponds to an optimum configuration of mutual closure of the mandible and of the maxilla of a specific patient, designed to receive the dental device (1);
e2. providing said preset occlusal key (4), by interposing a second pliable substance between the dental arches of the patient, at said predefined dental occlusion, and at said optimum configuration of mutual closure of the mandible and of the maxilla.
3. The method according to claims 1 and 2, characterized in that said preparation step a. consists in:
al . forming an impression of the maxilla and of the mandible;
a2. shaping, on the basis of the impression, said maxilla model (3) and said mandible model (2) of the specific patient.
4. The method according to one or more of the preceding claims, characterized in that said storage step b. consists in arranging said occlusal key (4), said mandible model (2) and said maxilla model (3), mutually arranged according to said predefined dental occlusion, on an articulator, in order to adjust the arrangement that corresponds to said predefined dental occlusion.
5. The method according to one or more of the preceding claims, characterized in that it provides, after said storage step b. and before said execution step c:
fl . positioning said one of said models (2, 3) in a thermoforming apparatus (7) provided with at least one tank (8) which is affected by means for generating a partial pneumatic vacuum and is designed to accommodate said one of said models (2, 3);
f2. filling the tank (8), with said one of said models (2, 3) accommodated therein, with a plurality of granules (9) preferably made of steel, in order to keep it in position during thermoforming.
6. The method according to one or more of the preceding claims, characterized in that it provides, after said execution step c. and before said working step d., for arranging, in a step g., said maxilla model (3) and said mandible model (2), with said first portion (6), on said articulator, for the correct closure, by means of said first pliable substance, of the gaps comprised between said mandible model (2), with said first portion (6), and said maxilla model (3), said models (2, 3) being arranged according to said predefined dental occlusion.
7. The method according to one or more of the preceding claims, characterized in that it provides, after said working step d., for finishing said device (1) in a step h., for the correction and removal of any defects.
8. The method according to claim 7, characterized in that it provides, after said finishing step h., for polishing said device (1), in a step i.
9. The method according to one or more of the preceding claims, characterized in that before said execution step c. said sheet (5) substantially faces said one of said models (2, 3) with a first thermoformable layer thereof, which is softer than a second layer that is superimposed on said first layer, said first pliable substance being arrangeable on said second harder layer.
10. The method according to claim 9, characterized in that said first layer is preferably made of a material of the type of thermoplastic polyurethane, said second layer being preferably made of a material of the type of polyesters and even more preferably of the type of polyethylene terephthalates.
11. The method according to one or more of the preceding claims, characterized in that said first pliable substance is constituted by acrylic resin.
12. The method according to one or more of claims 1 to 10 and as an alternative to claim 1 1 , characterized in that said first pliable substance is constituted by wax.
13. The method according to one or more of the preceding claims, characterized in that said second pliable substance is constituted by a material based on bisacrylates.
14. A dental device, characterized in that it comprises a first portion (6), which has a first surface region that is substantially complementary to the shape of one of the model of a mandible (2) and the model of a maxilla (3) of a patient, said first portion (6) being obtained by thermoforming an at least partially thermoformable sheet (5) which faces said one of said models (2, 3) of the patient, a second portion being superimposed on said first portion (6) and having a second surface region, which is opposite to said first surface region and is substantially complementary to the shape of the other one of said models (2, 3), said second portion being modeled by manual working of a first pliable substance, inserted between said first portion (6), mated with said one of said models (2, 3), and said other one of said models (2, 3), mutually arranged according to said predefined dental occlusion, up to the complete closure of the gaps comprised between said models (2, 3), with said first portion (6) coupled.
15. The dental device according to claim 14, characterized in that said sheet (5) comprises a first thermoformable layer, which is provided with said first surface region, said first layer being made of a material such as thermoplastic polyurethane and being softer than a second layer, which is superimposed on said first layer and is made of a material of the type of polyesters, and even more preferably of the type of polyethylene terephthalates, said first pliable substance being distributed on said second harder layer.
Description  (OCR text may contain errors)

METHOD FOR MANUFACTURING DENTAL DEVICES, AND DENTAL DEVICE

The present invention relates to a method for manufacturing dental devices and to a dental device.

As is known, in the field of dentistry the expression "dental occlusion" designates the way in which the teeth make mutual contact: sometimes it is necessary to force a change thereof in order to remedy a non-optimum closure, which can cause various pathologies and problems.

The way in which the teeth make mutual contact, and therefore the way in which each person closes his or her mouth, in fact depends on the shape of the teeth, of the mandible and the maxilla, and more precisely on the shape that best provides mutual mating (interlocking); this manner, which is termed occlusion, can however, in some cases, not correspond to the optimum configuration for the muscles of the face and neck and of the associated joints.

In such cases, the patient who has problems linked to poor dental occlusion can complain of negative effects on the posture of the spinal column and therefore of the back, shoulders, head and neck, and on muscular force and on joints, said effects being indeed caused by incorrect movements and by an incorrect closure of the mandible and maxilla.

These problems, moreover, are widespread and strongly felt, among sportspeople, since the intense physical activity that they perform inevitably increases the damage caused by incorrect occlusion.

In this context it is common to resort to removable devices or appliances (sometimes known as "bites" or "orthotics"), which can be clamped between the jaws typically in order to remedy morphological defects of teeth and/or to correct the dental occlusion of a patient.

In practice, however, difficulty is observed in providing, in a simple and practical manner, devices that are adapted to the specific requirements of each individual patient and, more precisely, are capable of correcting the particular occlusion defects that are observed.

Moreover, it should be noted that it is often difficult to combine the need to ensure the durability of the device (which causes an increase in its hardness) with the goal of avoiding patient discomfort (caused indeed by excessive hardness).

The discomfort for the patient, moreover, is often worsened by the considerable space occupation that devices of the known type usually have.

The aim of the present invention is to solve the problems described above, by providing a method for manufacturing dental devices that are contoured specifically to meet the needs of the patients for which they are intended.

Within this aim, an object of the invention is to provide a dental device that allows meeting the requirements and solving the problems of each patient without causing him or her discomfort.

A further object of the invention is to propose a method for manufacturing dental devices that is capable of correcting defects in dental occlusion while maintaining optimum dimensions and space occupation.

Another object of the present invention is to provide a dental device that can be used by sportspeople and patients in general to eliminate postural problems.

Another object of the invention is to propose a method that can be provided easily starting from commonly commercially available elements and materials.

Another object of the invention is to provide dental devices that have low costs and are safe in application.

This aim and these objects are achieved by a method for manufacturing a dental device, which consists in preparing a model of a mandible and a model of a maxilla of a patient, intended to receive the device; storing a predefined dental occlusion for said models, which corresponds to a specific closure mode of the dental arches of the patient and to a predefined occlusal key; performing a thermoforming treatment on a sheet that is at least partially thermoformable and substantially faces one of said models, for mating with said one of said models and for production of a first portion of a dental device, which has a first surface region that is substantially complementary to the shape of said one of said models; working manually a first pliable substance inserted between said first portion, coupled to said one of said models, and the other one of said models, mutually arranged according to said predefined dental occlusion, for the complete closure of the gaps comprised between said models, with said first portion mated, with consequent modeling of a second portion of the device and obtainment of a complete dental device, which can be clamped between the maxilla and the mandible of a patient according to said predefined dental occlusion and has a second surface region, which is opposite said first surface region and is substantially complementary to the shape of said other model between said mandible model and said maxilla model.

This aim, as well as these and other objects which will become more apparent hereinafter, are also achieved by a dental device, characterized in that it comprises a first portion, which has a first surface region that is substantially complementary to the shape of either the model of a mandible or the model of a maxilla of a patient, said first portion being obtained by thermoforming an at least partially thermoformable sheet which faces said one of said models of a patient, a second portion being superimposed on said first portion and having a second surface region, which is opposite with respect to said first surface region and is substantially complementary to the shape of the other one of said models, said second portion being modeled by manual working of a first pliable substance^ inserted between said first portion, mated with said one of said models, and said other one of said models, which are mutually arranged according to said predefined dental occlusion, until the gaps comprised between said models are completely closed, with said first portion coupled.

Further characteristics and advantages of the invention will become more apparent from the description of a preferred but not exclusive embodiment of the method and of the dental device according to the invention, illustrated by way of non-limiting example in the accompanying drawings, wherein:

Figure 1 is a block diagram of the method according to the invention;

Figure 2 is a perspective view of the device according to the invention;

Figure 3 is a side elevation view of the mandible model and of the maxilla model, with the occlusal key;

Figures 4 to 7 are views of some steps of the method according to the invention.

With reference to the cited figures, the method according to the invention (shown schematically in Figure 1) aims at manufacturing dental devices, generally designated by the reference numeral 1 and also known as "orthotics" or "bites"; they are constituted substantially by variously shaped plates; which can be clamped between the maxilla and the mandible (and more precisely between the respective dental arches), for example to remedy morphological defects of the teeth and/or to correct the manner in which the teeth make contact (a manner which is referred to, in the art and below in the present description, by the expression "dental occlusion").

The method of manufacturing dental devices 1 according to the invention therefore consists, in a step a., in preparing a model of a mandible 2 and a model of a maxilla 3 (typically but not exclusively made of alginate) of a patient who is to receive and use the device 1.

In a step b., the method provides for storing a predefined dental occlusion for the models 2, 3, which corresponds to a specific closure mode of the dental arches of the patient, and to a preset occlusal key 4 (which will be delved into hereinafter). Then, in a step c, the method provides for performing a thermoforming treatment on an at least partially thermoformable sheet 5, which preliminarily is arranged substantially so as to face one of the models 2, 3.

It is specified that for the sake of simplicity, in the following of the present description reference shall be made repeatedly to the possibility that the sheet 5 faces, in step c, the mandible model 2, as can be seen schematically in Figure 5 by way of non-limiting example. However, it is useful to stress that the protective scope claimed herein also includes the possibility that the sheet 5 faces, in step c, the maxilla model 3, although only a few mentions will be made hereinafter regarding this possibility.

The thermoforming treatment allows in practice the mating of the sheet 5 with the mandible model 2, which it faced, and thus the production of a first portion 6 of the device 1 (shown schematically in Figure 6), which has a first surface region that is substantially complementary to the shape of the mandible model 2 (or to the maxilla model 3), thanks to the thermoforming process, which causes the sheet 5, by pneumatic suction, to adhere against the mandible model 2 and thus allows the optimum shape mating of the first portion 6 with the lower dental arch replicated by the mandible model 2.

After obtaining, as described above, the first portion 6 of the dental device 1 , the method according to the invention provides, in a step d., for the manual working of a first pliable substance which is inserted between the first portion 6, which is mated to the mandible model 2 (or, as shown, to the maxilla model 3), and the maxilla model 3, with the models 2, 3 mutually arranged according to the predefined dental occlusion.

By way of non-limiting example of the application of the invention, mention is made right now of the possibility that said first pliable substance might be constituted by acrylic resin (for example clear resin); as an alternative, without exhausting the possible types of pliable substances that can be used in the scope of the method claimed herein, the first pliable substance can be Constituted by wax.

In any case, whatever the first pliable substance chosen, its working allows closure of the gaps comprised between the maxilla model 3 and the mandible model 2 (with the first portion 6 mated), until a second portion of the device 1 is modeled and the complete dental device 1 is thus obtained, which can be clamped between the maxilla and the mandible of a patient, in order to make him assume the predefined dental occlusion, and has a second surface region, which is opposite to the first surface region, which is substantially complementary to the shape of the maxilla model 3 (and to the upper dental arch formed by it).

Conveniently, the method according to the invention provides, before the step a. of preparing the models 2, 3, for determining, in a step el ., the predefined dental occlusion, which corresponds to an optimum configuration of mutual closure of the mandible and of the maxilla of a specific patient who is to receive the dental device 1.

It should be specified that the ways in which a specialist can determine the predefined dental occlusion that one wishes to replicate with the models 2 and 3 (and that one wishes a patient affected by various disorders to assume thanks to the device 1) can be numerous.

For example, by way of non-limiting example, mention is made of the possibility for the determination step el . to interpose, between the mandible and the maxilla of the specific patient for whom the device 1 is intended, two cylinders (or sheets or strips) made of a material such as cotton.

If, for example, the patient complains of pains or problems involving the head, neck, shoulders, posture of the spinal column and therefore of the back, the legs or feet, this procedure in fact allows identifying the optimum configuration of mutual closure of the mandible and of the maxilla of said patient: it is sufficient to make him perform simple gestures and movements (typically swallowing and walking), by positioning and repositioning the cylinders, to check (of course if said pains are due to an incorrect way of closing the teeth) for any disappearance of the pain and determine (in step el .) the predefined dental occlusion.

Moreover, the possibility is not excluded, and is in any case within the protective scope claimed herein, of determining, in step el ., the predefined dental occlusion in another manner (for example by means of muscle tests of various kinds) as a function of the specific requirements.

In any case, having identified the predefined dental occlusion, which the patient shall have to assume by clamping between his dental arches the device 1 according to the invention, it is possible to provide, in a step e2., the predetermined occlusal key 4, by interposing a second pliable substance between the dental arches of the patient while said arches are arranged in the predefined dental occlusion and therefore in the optimum configuration of mutual closure of the mandible and of the maxilla.

By way of non-limiting example of the embodiment of the invention, it is specified that the second pliable substance, and therefore the occlusal key 4, can be made of a material based on bisacrylates, such as LuxabiteŽ, which is a registered trademark.

In any case, whatever the material chosen, the occlusal key 4 is thus substantially a variously shaped strip, which replicates the gaps that are present between the dental arches of the patient when they are arranged in the predefined dental occlusion; on its basis it is thus possible to obtain a device 1 which in practice induces the patient to close the mandible and maxilla according to said occlusion.

In particular, the preparation step a. provides for forming, in a step al ., an impression of the maxilla and of the mandible (in ways which can also be of a known type and for example by interposing between the mandible and the maxilla the material intended to constitute the impression, in the pasty state, in order to make it assume the desired shape and then wait for it to harden). On the basis of the impression it is thus possible to shape, in a step a2., a model of the maxilla 3 and a model of the mandible 2 of the specific patient for whom the device 1 is being manufactured, which can be mutually arranged according to the predefined dental occlusion by means of the occlusal key 4 already obtained in the preceding steps.

For ensuring that the elements described above are kept in the desired mutual configuration (which corresponds to the predefined dental occlusion) and allowing the execution of the subsequent steps, as will become more apparent hereinafter, conveniently the storage step b. provides for placing the occlusal key 4, the mandible model 2, the maxilla model 3 (obtained according to the methods described in the preceding paragraphs), mutually arranged according to the predefined dental occlusion, on an articulator in order to adjust the mutual arrangement that corresponds to the predefined dental occlusion.

Conveniently, according to a method of execution that is of considerable practical interest and is mentioned by way of non-limiting example of the application of the invention, the method provides, after step b. for storage and before step c. for execution, for placing, in a step fl ., at least the mandible model 2 (or the maxilla model 3) in a thermo forming apparatus 7, which is provided with at least one tank 8, which is affected by means for generating a partial pneumatic vacuum and is designed to accommodate the mandible model 2 (or the maxilla model 3).

After accommodating, in step fl ., the mandible model 2 in the tank 8, the method provides for filling, in a step f2., the tank 8 with a plurality of granules 9, preferably made of steel, in order to keep the mandible model 2 in position during thermoforming (as can be seen in Figure 4).

Thanks to the positioning step fl . and the filling step f2., carrying out step c. of execution of the thermoforming treatment leads to the obtainment of the first portion 6 (starting from the sheet 5), mated with the mandible model 2. It is useful to note, in any case, that the possibility is not excluded of performing the step c. of execution (like the others) without resorting to the preliminary activities described above and/or according to methods that are different from the ones illustrated in the present description, without thereby abandoning the protective scope claimed herein.

Advantageously, the method according to the invention provides, after the execution step c. and before the working step d., for arranging, in a step g., the maxilla model 3 and the mandible model 2, with the first portion 6 obtained in the preceding steps, on the articulator, in order to reproduce the configuration that corresponds to the predefined dental occlusion, and thus perform correct closure (thanks to working of the first pliable substance, in step d.) of the gaps comprised between the mandible model 2, with the first portion 6, and the maxilla model 3 (with the models 2, 3 arranged according to said predefined dental occlusion).

After the working step d., positively the method according to the invention provides for finishing the dental device 1 , in a step h., to correct and remove any defects.

Moreover, after the finishing step h., the method according to the invention provides, in a step i., for polishing the device 1 in order to complete its construction.

With reference to the preferred but not exclusive embodiment of the method according to the invention, before starting the step c. of performing the thermoforming treatment the sheet 5 faces the mandible model 2 (or the maxilla model 3) with a first thermoformable layer thereof, which is softer than a second layer which is superimposed on the first layer; the first pliable substance can thus be positioned on said second harder layer.

More particularly, with further reference to the preferred but not exclusive constructive solution, the first layer is preferably made of a material of the type of thermoplastic polyurethane (also known by the acronym "TPU"), while the second layer is preferably made of a material of the type of polyesters and even more preferably of the type of polyethylene terephthalates (also known by the acronym "PETG"). For example, it is noted that it is possible to arrange, so that they face the mandible model 2, sheets 5 which are commercially available under the name Erkoloc-Pro and have the particularities described above.

The dental device 1 according to the invention, visible in Figure 2, comprises a first portion 6, which in turn has a first surface region which is substantially complementary to the shape of the model of a mandible 2 and of a lower dental arch of a patient (or to the shape of the model of a maxilla 3 and of an upper dental arch): said first portion 6 is obtained by thermoforming a sheet 5 (which is at least partially thermoformable) which faces the model 2 of the mandible of the patient.

A second portion is superimposed on the first portion 6 and has a second surface region which is opposite to the second surface region and is substantially complementary to the shape of the model of a maxilla 3 and of an upper dental arch (or the shape of the model of the mandible 2 and of the lower dental arch): the second portion is modeled by working a first pliable substance, which is inserted between the mandible model 2, with the first portion 6, and the maxilla model 3 (or vice versa), mutually arranged according to said predefined dental occlusion, until the gaps comprised between the models 2 and 3 are completely closed, with the first portion 6 coupled.

In particular, the sheet 5 comprises a first thermoformable layer, which is provided with the first surface region: said first layer is made of a material of the type of thermoplastic polyurethane and is softer than a second layer, which is superimposed on the first layer and is made of a material of the type of polyesters, and even more preferably of the type of polyethylene terephthalates. The first pliable substance is distributed on said second layer, which is intentionally selected with a greater hardness.

The method according to the invention, described in its steps in the preceding pages, therefore makes it possible to provide to a patient who requires a remedy to an incorrect manner of closing his teeth, a dental device 1 which, once clamped in the mouth, causes the rearrangement of the dental arches according to the predefined dental occlusion, selected as a function of a preliminary analysis and capable of eliminating the symptoms and pains caused by an incorrect position of the teeth, of the maxilla and of the mandible.

More precisely, as noted, the predefined dental occlusion can be determined in step el . by means of adapted tests aimed at verifying how any pains affecting the back, the legs, etcetera are due to any incorrect manner of closing the teeth (which therefore can be corrected by means of the device 1 according to the invention).

In any case, once the predefined dental occlusion has been determined in step el ., it is possible to provide, in a step e2., the occlusal key 4, which replicates the interspaces that are present between the dental arches of the patient, when they are arranged in the predefined dental occlusion.

The method then provides for forming, in step al ., an impression of the maxilla and of the mandible and on the basis of this impression it is thus possible to shape, in step a2., a model of a mandible 2 and a model of a maxilla 3, which can then be placed on an articulator (in the mutual arrangement of Figure 3) in order to store, in step b., the predefined dental occlusion for the models 2, 3.

The mandible model 2 (or the maxilla model 3) can then be removed from the articulator to be positioned, in step fl ., in the tank 8 of the thermoforming apparatus 7, which is subsequently filled, in step f2., with the steel granules 9.

It is thus possible, in step c, to perform the thermoforming treatment and produce (with the sheet 5 of thermoformable material, which faces the mandible model 2) the first portion 6 of the dental device 1 , which has a first surface region that is complementary to the mandible model 2 (and therefore to the dental arch of said mandible).

The first portion 6 of the device 1 and the mandible model 2 can thus be arranged, in step g., on the articulator, in opposition to the maxilla model 3, in order to allow -the subsequent execution of step d. of working a first pliable substance to close the gaps comprised between the mandible model 2, with the first portion 6, and the maxilla model 3, with consequent modeling of the second portion of the device 1 (in this manner, the second portion can also have greater or smaller thicknesses so as to follow the different center distances that the patient may have between the dental arches) and consequent obtainment of the complete device 1.

The closure of the gaps is necessary because since the first portion 6 is produced by thermo forming a sheet 5, it is assuredly spaced from the maxilla model 3 : by modeling the pliable substance ˇ while the various elements involved are fixed to the articulator, in the predefined occlusion, the second portion that is obtained is absolutely complementary to the maxilla model 3 and therefore to the actual maxilla of the patient.

Finally, the device 1 can be improved and rendered perfectly suitable for use by means of the finishing step h. and the polishing step i.

In practice, therefore, by means of the method according to the invention it is possible to manufacture a device 1 that adapts perfectly to the maxilla and the mandible of the patient (arranged in the predefined occlusion, selected so as to eliminate the problems and symptoms reported by the patient), thanks to the first surface region, which by thermoforming is rendered complementary to the lower dental arch, and thanks to the second surface region, which by modeling of the first pliable substance is instead complementary to the upper dental arch.

Moreover, this makes it possible to manufacture devices 1 that can be used effectively not only by patients in general but also by sportspeople to eliminate postural problems or other issues.

The complete adaptability of the device 1 thus manufactured to the mandible and maxilla of the patient indeed makes it possible to avoid the danger of discomfort to the customer and to ensure, at the same time, that optimum dimensions and space occupations (lingual and vestibular) are maintained (thus avoiding other problems and pains that are often present when resorting to devices, such as bites or orthotics, of a known type).

To ensure that compact space occupations are maintained, it is specified that sheets 5 having very low thicknesses (for example 1.2 mm) are adopted.

A contribution to the above-cited assurance of lack of patient discomfort is given by the choice to use, for thermoforming, a sheet 5 which has two layers, the first one, intended for contact with the mandible of the customer, being softer than the second one, which is simply intended to support the first pliable substance and therefore the second portion of the device 1 , but without making contact, during use, with anatomical tissues of the patient.

In practice it has been found that the method and the device according to the invention fully achieve the intended aim, since the manufacture of a device that comprises a first portion, provided with a first surface region obtained by thermoforming a sheet that faces one of the two models, and a second portion provided by modeling a pliable substance and having a second surface region, which is complementary to the shape of the other one of the two models, makes it possible to obtain devices that are shaped specifically to meet the requirements of the patients for whom they are intended.

The invention thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the appended claims; all the details may furthermore be replaced with other technically equivalent elements.

In the described exemplary embodiments, individual characteristics, given in relation to specific examples, may actually be interchanged with other different characteristics that exist in other exemplary embodiments.

In practice', the materials used, as well as the dimensions, may be any according to the requirements and the state of the art.

Where technical features mentioned in any claim are followed by reference signs, those reference signs have been included for the sole purpose of increasing the intelligibility of the claims and accordingly such reference signs do not have any limiting effect on the interpretation of each element identified by way of example by such reference signs.

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Non-Patent Citations
Reference
1None
Classifications
International ClassificationA61C7/08
Cooperative ClassificationA61C7/08
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