WO2015071718A1

WO2015071718A1 - Oral device

Info

Publication number: WO2015071718A1
Application number: PCT/IB2014/002358
Authority: WO
Inventors: Giangiacomo ZABBAN
Original assignee: Farmac-Zabban S.P.A. Farmaceutici Medicazione Articoli Chirurgici
Priority date: 2013-11-13
Filing date: 2014-11-06
Publication date: 2015-05-21
Also published as: ITBO20130622A1

Abstract

An oral device (1) to prevent the passage of a food bolus (B) from the oral cavity or mouth (101) to the pharynx (102) of a user (100) comprises a main body (2) and releasable coupling means (6, 7) protruding from the main body (2) to couple the main body (2) to the teeth (105) of the user (100); the main body (2) protrudes, when in use, between the soft palate (106) and the tongue (103) of the user (100).

Description

DESCRIPTION

ORAL DEVICE

Technical field

This invention concerns an oral device and in particular a barrier for the oral cavity designed to prevent or hinder the swallowing of a food bolus. Background art

In the modern world, the activity of eating has largely lost its main function of feeding oneself in order to survive that was typical ancient man and is still typical of animals.

The activity of eating, while still being necessary for survival, is now associated with pleasure due to the taste experienced on placing food in the mouth, connected with the various flavours that are perceived by the taste buds.

The reason why people put food in their mouths, in addition to the bod's need of sustenance, is connected to the chemical interactions between the brain and the taste receptors, the taste buds situated mainly on the tongue and the palate. The various flavours - savoury, sweet, bitter, sour - mixed in with our favourite foods cause pleasant sensations that are further enhanced by the aromas, by the consistency of the food (soft, hard, crunchy, moist), by the hot or cold temperature and by other sensations such as spicy or piquant.

The activity of eating is, however, connected with many contraindications which, from the lesser to the more serious ones, can include stomach ache, sleepiness, possible intestinal problems, a tendency to put on weight, obesity, diabetes and other diseases associated with eating too much food or certain types of food in quantities harmful to the body.

The need for food, one of man's primary needs, has in some parts of the world become a desire for food that is increasingly stimulated by a generalised proposal of food that is tasty but is often not very healthy because it is fatty and rich in calories.

There are known methods for reducing the amount of food eaten or for eating in a healthier way such as, for example, diets of various kinds, which are based on the psychological will to pursue them or based on consuming foods, liquids or supplements that induce a feeling of fullness. There are also known devices which reduce the volume of the stomach or the oral cavity which force a reduction of the quantity of food introduced in the digestive tract.

A first example of a device that reduces or selects the amount of food that can be introduced in the oral cavity and thus ingested is described in the document US447 771.

The device described is substantially a mobile grid-shaped barrier, fitted by dental professionals, that blocks the entry to the stomach of large pieces of solid food and forces the user to eat small pieces of food or small amounts of liquids.

A different device for weight control is for example described in US2012037168 and consists of an appropriately shaped plate to be positioned under the palate in order to reduce the volume of the oral cavity available for the introduction of food.

Another device is described in the document US8375954 and is designed to limit or hinder the action of chewing by forcing the user to chew more slowly and thus slow down the eating and ingestion of food.

The known solutions thus artificially create difficulties in managing the food introduced in the oral cavity, allowing only small pieces of food to be slowly chewed and thus destroying the pleasure of eating.

In addition, many know solutions require the intervention of dental professionals for the permanent fixing of barriers or plates to the teeth or bones.

Disclosure of the invention In this context, the main purpose of this invention is to provide an oral device that does not have the above-mentioned drawbacks.

One aim of this invention is to provide a functional oral device for the treatment of eating disorders such as obesity, diabetes and anorexia.

Another aim of this invention is to provide an oral device that allows the user to fully enjoy the pleasure of eating without the contraindications of stomach ache, sleepiness, possible intestinal disorders and the tendency to put on weight.

The technical purpose and aims specified are substantially achieved by an oral device comprising the technical features described in claim 1 and by a kit for controlling the consumption of food according to claim 22.

Brief description of drawings

Further features and advantages of the present invention are more apparent in the non-limiting description of a preferred embodiment of an oral device, as illustrated in the accompanying drawings, in which:

Figure 1 is a schematic side view, partly in blocks, of a kit for controlling the consumption of food in accordance with the present invention;

- Figure 2 is a schematic front view, partly in blocks, of an oral device in accordance with the present invention, forming part of the kit of Figure 1.

Figure 3 is a schematic perspective view of a second embodiment of an oral device in accordance with the present invention, forming part of the kit of Figure 1 ;

Figure 4 is a schematic bottom plan view of the oral device of Figure 3;

Figure 5 is a rear schematic view of the oral device of Figure 3;

Figure 6 is a section view of the device of Figure 3 through the line VI-VI of Figure 4; Figure 7 is a section view of the device of Figure 3 through the line VI-VI of Figure 4 inserted in the oral cavity of a user;

Figure 8 is a schematic perspective view of a detail of the device of Figure 3.

Detailed description of preferred embodiments of the invention

With reference to the accompanying drawings, the numeral 1 denotes an oral device according to this invention.

The device 1 , as will be clarified better below, is designed for a user 00 in order to prevent the passage of a food bolus from the oral cavity or mouth 101 of the user 100 to the user's pharynx 102.

The device 1 preferably does not limit the movements of the tongue 103 and allows the ingestion of liquids.

Entering into schematic detail of the oral cavity or mouth 101 , it can be seen that in man this is contained between the palatal arch or cavity 104, the gingival-dental arches with the teeth 105 and the so-called floor of the mouth which, through the isthmus of the fauces, communicates with the pharynx 102 and in which the tongue 103 is situated. The palatal arch 104 is osseous in the front two-thirds, also known as the "hard palate", while the rear third, also known as the "soft palate", is lined by mucous membrane; the soft palate is denoted with the numeral 106.

Food is ground and mixed with saliva in the mouth 101 , and reduced to mass called a bolus B, which, by means of swallowing, passes through the pharynx 102 and normally proceeds to the esophageal canal.

After passing through the esophageal canal, the food bolus B reaches the stomach where the food is digested, releasing nutritional substances into the body but also harmful substances.

The pleasure of "eating" is limited to what takes place in the mouth, while the other steps do not provide any pleasure other than the feeling of repletion. The sensation of repletion starts to be felt about twenty minutes after the first swallowing action and in these twenty minutes the process of eating continues, with the person introducing even excess amounts of food into the body because of the continuing sensation of hunger.

The device 1 comprises a main body 2 which extends, when fitted, between the soft palate 106 and an upper or lingual surface of the tongue 103.

The body 2 presents a first direction D1 of development which, when fitted, is transversal to the mouth 101 and a second direction D2 of development, transversal, in particular perpendicular, to the first direction D1 of development.

In a preferred embodiment, shown for example in Figure 2, the main body 2 presents rounded edges in order to prevent abrasions due to contact with the inside of the mouth 101 , for example with the palatal arch 104 or with the tongue 103.

When the device is in place, the second direction D2 of development is substantially vertical inside the mouth 101.

The device 1 comprises releasable coupling means extending from the main body 2 for attaching the main body 2 to the teeth 105 of the user 100.

With respect to the main body 2, the releasable coupling means are positioned so that the main body 2 extends, when the device is in place, between the soft palate 106 and the tongue 103.

In particular, the releasable coupling means are positioned with respect to the main body 2 so that, when the device is in place, the second direction

D2 is between the soft palate 106 and the tongue 103.

The main body 2 preferably presents a lower edge 2a positioned, when the device is in place, close to the tongue of the user 00.

The main body 2 defines a barrier or baffle positioned, when the device is in place, transversally, in particular perpendicularly, to the soft palate 106.

The releasable coupling means and the main body 2 are configured in such a way that the main body 2 is positioned, when the device is in place, in the oral cavity 101 with the second direction D2 substantially perpendicular to the soft palate 106.

The main body 2 preferably presents a width, measured along the direction D1 , that fills the palatal arch 104.

The main body 2 preferably presents a height, measured along the direction D2, that allows the user to breathe and speak, in particular allowing all the movements of the tongue 103 necessary for speech.

In a preferred embodiment, the main body 2 is made from a material that can be modelled in order to adapt to the shape and size of the oral cavity 101 of the user 100.

With reference to Figure 2 in the embodiment shown, the main body 2 comprises a first portion 3 and a second portion 4 connected to each other.

The first portion 3 and the second portion 4 are relatively mobile along the direction D1 , in the example shown, between a forward and a retracted position.

The second portion 4 is preferably inserted telescopically inside the portion 3 and is mobile with respect to the first portion.

The oral device 1 comprises means, schematized with a block 15, for blocking the first portion 3 and the second portion 4 in any relative position between the retracted and forward positions including the actual retracted and forward positions.

The blocking means 15 comprise for example a screw mechanism or a clip or spring mechanism or other type.

In one embodiment, the main body 2 comprises at least one filtering portion 5 , shown for example in Figure 2.

The filtering portion 5 is shaped and structured to allow, when the device is in place, liquids to pass through and to prevent passage of a food bolus. With reference to Figure 2, entering into more detail as regards the coupling means, it can be seen that these are preferably designed and fashioned for coupling the device 1 to the second and/or third molars of the upper dental arch 107, preferably both on the right and the left.

Coupling on the second and/or third molars of the upper dental arch 107 preferably allows the user 100 to easily fit and remove the device, even several times a day.

The coupling means are preferably in the form of shaped grippers, for example in rigid rubber, that fit on the teeth 105.

Advantageously, the coupling means comprise mechanisms of the type used for known devices fitted in the oral cavity 101 such as braces, dentures and various types of dental prostheses.

With particular reference to Figure 2, the releasable coupling means comprise gripper means.

The releasable coupling means comprise a first and second coupling element 6, 7 extending from opposite ends of the main body 2.

The first coupling element 6 and the second coupling element 7 preferably extend along the direction D1.

More specifically, the first and second coupling elements 6, 7 respectively comprise an arm 8 and an arm 9 that extend away from the main body 2. The first and second coupling elements 6, 7 each comprise a prong 10, 11 extending from a free end of the respective arm 8, 9 transversally to the arm 8, 9.

The prongs 10, 11 preferably develop according to the direction D1 and are elastically mobile towards the main body 2 and away from it.

The coupling elements 6, 7 thus defined allow coupling to the respective tooth 105 which remains gripped between the prong 10, 11 and one edge of the main body 2.

The elasticity of the prongs 10, 11 allows easy positioning of the device 1 and easy removal according to the requirements of the user 100.

In actual fact, the first and second coupling elements 6, 7 each present or border a respective concave portion designed to engage, when the device is in place, with a respective tooth 105 of the user 100. According to what is shown in Figure 2, the concave portions of the first and second coupling elements 6, 7 preferably face upwards when the device 1 is in place. The concave portions of the first and second coupling elements 6, 7 are preferably turned towards the direction D2.

In a preferred embodiment, the main body 2 comprises an upper portion 12 and a lower portion 13 articulated, for example by means of a hinge 14, to the upper portion 12.

The releasable coupling means preferably extend from the upper portion 12, while the lower portion 13 is free to move with respect to the upper portion 12.

The hinge 14 preferably has a rotation axis parallel to the direction D1.

When the device is in place, the user 100 can thus raise and lower the lower portion 13, for example by means of the tongue 103, so as to swallow liquids more easily between one sip and the next or to swallow a piece of food or not.

A second embodiment of the oral device 1 is illustrated in Figures 3 to 7.

According to what is shown, the main body 2 comprises, with reference to when the device is in place, an upper portion 20 and a lower portion 21.

The portion 20 and the portion 21 are made from a single piece, that is to say the body 2 is made from a single piece preferably by moulding.

The body 2 is preferably made from plastic material, for example preferably from food-grade silicone.

With particular reference to Figure 6, in cross-section, it can be observed that the portion 20 presents a respective prevalent direction of development D20 and the portion 21 presents a respective prevalent direction of development D21.

The portion 20 and the portion 21 are angled with respect to each other, that is to say the respective prevalent directions D20, D21 of development form an angle "a" less than sexagesimal 180° with reference to Figure 6. The portions 20 and 21 define in actual fact a concave area, that is to say the main body 2 is concave. The portion 20 preferably presents a sharp corner 20a.

The portion 21 preferably presents a sharp corner 21a.

The concave area of the body 2, when the device is in place, preferably faces the exterior of the oral cavity 101 , that is to say the opening of the mouth.

The coupling means of the body 2, better described below, are shaped in order to allow the aforesaid positioning, when the device is in place, of the barrier 2.

Once positioned in the oral cavity, the barrier 2 prevents the bolus from being swallowed.

The preferred embodiment shown for the body 2, in particular the use of elastic material and the angulation of the portions 20 and 21 , advantageously allow deformation of the body 2 itself. Advantageously, the barrier 2 can close, that is to say the angle "a" can decrease on upward pressure by the tongue 103 countered, in particular, by the palatal arch 104.

In this way, the physiological movements of the user 100 are not hindered by the device 1 inserted in the oral cavity 101.

In the preferred embodiment shown in figures 3 to 8, the aforesaid releasable coupling means comprise, for fitting of the device 1 on the teeth 105 of the user 100, a first and second coupling element 22, 23 extending from opposite sides with respect to the main body 2.

The first coupling element 22 and the second coupling element 23, shown in particular in figure 8, preferably extend in the direction D1 from opposite sides with respect to the main body 2.

The coupling elements 22, 23 are connected to the body 2; in a preferred embodiment, the body 2 comprises elements 24, 25 of engagement for the coupling elements 22, 23 that ensure the restraint of the coupling elements 22, 23 with the barrier 2. In the preferred embodiment shown, the coupling elements 22, 23 shown are substantially "U" shaped and each present a respective base portion 26 and a respective first and second arm 27, 28.

For descriptive simplicity, the numeral 27 indicates the inner arm for both the elements 24 and 25, considering a configuration when the device is in place, that is to say the arm 27 connecting with the body 2, in particular with the respective element 24, 25 of engagement.

The arms 27, 28 are elastically pliable in order to fit on the teeth 105 and hold the device 1 in place, forming gripper means.

The arms 27, 28 form, in other words, elastic clamps.

The coupling elements 22, 23 comprise a plurality of coil-wound portions

29 that improve the elastic capacity of the elements 22, 23.

In one embodiment, the coupling elements 22, 23 comprise a plurality of inserts 30, for example in silicone and preferably arranged to correspond with the portions 29, to improve the grip on the teeth 105 or in general on the upper dental arch 107.

The coupling elements 22, 23 substantially develop in a horizontal direction with particular reference to figure 4, and form respective arches. The coupling elements 22, 23 are made for example from metal, plastic, silicone or rubber and may comprise a coating, not shown, that can be in a different material.

According to what is shown, the coupling elements 22, 23 are configures in order to fit around respective rear extremities 107a, 07b of the upper dental arch 07.

The device 1 is designed to be fitted to the second and/or third molars of the upper dental arch 107 by means of the coupling elements.

The user 100 can fit the device 1 as required and may also remove it and replace it during a single meal in order to "fully" eat a sufficient amount of food to feel full and to taste without swallowing the excess amount of food to satisfy the appetite and the psychological desire for food without weighing down the stomach and putting on weight. As far as the materials are concerned, in the embodiment shown in figure 2 the main body and the releasable coupling means are preferably made in a single piece.

The device 1 is preferably made from plastic, rubber or silicone or also from metal, wood, cellulose and other materials.

The device 1 is preferably made from non-toxic and tasteless material so as not to interfere with the taste of food.

Since the oral device 1 preferably does not completely close the pharynx, it allows the passage of liquids, including the food bolus B if the foodstuff is particularly liquid or liquefied by being considerably impregnated with saliva. The amount of liquid bolus B swallowed will depend on the wishes of the user 100.

Advantageously, reducing the amount of food swallowed reduces the feeling of a full stomach which is one of the reasons for feeling thirsty and wanting to drink.

The subject of this invention is also a kit for controlling the consumption of food by the user 100.

The kit 200 comprises the oral device 1 and a suction device 201 to suction the food bolus B from the oral cavity 101.

The substantially known device 201 comprises a recipient 202 equipped with a vacuum pump 203, for example electronic or manual, and a tube 204 through which the bolus B can be suctioned from the mouth 101.

The device 201, in fact, makes it possible to empty the oral cavity 101 by removing the food bolus B; the pump 203 suctions the bolus B through the tube 204, which preferably has an internal diameter of around 0.5 cm, inserted in the oral cavity.

When the user 100 has finished tasting the food in the oral cavity 101 , and the sensations of taste, consistency and temperature have faded because the food has been ground down by chewing and is impregnated with saliva, the user 100 inserts the tube 204 between the lips and suctions the ground- up and saliva-soaked bolus B, freeing the oral cavity for the next piece of food.

The tube 204 is preferably made from rubber or plastic or other materials; similar to the device 1 , the tube 204 is preferably made from non-toxic material so that it can be inserted in the oral cavity 101.

Once the device 1 has been coupled to the upper dental arch, in particular to the teeth 105, the user inserts the tube 204 in the mouth between one piece of food and the next in order to empty the oral cavity of the ground-up and saliva-soaked bolus B.

Advantageously, if all of the bolus B in the oral cavity is not suctioned, the remaining amount will be mixed with the next piece of food. The suctioned food bolus B is collected in the recipient 202 and at the end of the meal the accumulated bolus B must be thrown away and the recipient 202 is preferably washed for the next use. After its, the tube 204 through which the food bolus B passes and the oral device 1 are also preferably washed.

The invention described above makes it possible to enjoy the sensations caused by eating any type of food, even the most fatty and calorie-rich food; the oral device 1 makes it possible to eat for a long time since the food stops in the oral cavity without passing the pharynx and from there to the stomach, thus avoiding the contraindications of eating such as stomach ache, sleepiness, possible intestinal disorders, a tendency to put on weight, obesity, diabetes and other diseases connected with the excessive consumption of food or of certain types of food harmful for the body.

Without giving up the pleasure of eating any type of food, even in large quantities, the user can dose the amount and type of food to be actually sent on to the stomach and which will release its nutritional substances. A greedy person can enjoy his or her favourite food in large quantities and for a long time, a diabetic person can enjoy sweet food, people with eating-related disorders, such as obesity or anorexia, can enjoy any food and in any amount without putting on weight. Psychologically, the use of the invention allows the user to avoid the sacrifices due to self-limiting food consumption and to fully enjoy one of life's pleasures without the negative consequences of a diet that is too free.

The invention makes it possible to separate the action of putting food in the oral cavity and chewing it, which is the activity connected with the pleasure of taste, from the action of swallowing with the consequent passage of food into the stomach and subsequent digestion which is not connected with any pleasure but only with the possible contraindications described above.

Claims

1. An oral device to prevent the passage of a food bolus (B) from the oral cavity or mouth (101) to the pharynx (102) of a user (100), comprising a main body (2) and releasable coupling means (6, 7, 8, 9, 10, 11 , 22, 23, 27, 28) protruding from said main body (2) to couple said main body (2) to the upper dental arch (107) of said user (100), said main body (2) protruding, when in use, between the soft palate (106) and the tongue (103) of said user (100), said device being characterised in that

said main body (2) forms a barrier positioned, when in use, transversally, in particular perpendicularly, to the soft palate (106).

2. An oral device according to claim 1 , wherein said main body (2) presents a lower edge (2a, 21a) positioned, when in use, close to the tongue (103) of said user (100).

3. An oral device according to any of the preceding claims, wherein said releasable coupling means (6, 7, 8, 9, 10, 11 , 22, 23, 27, 28) comprise gripper means (2, 10, 11 , 27, 28).

4. An oral device according to any of the preceding claims, wherein said releasable coupling means (6, 7, 8, 9, 10, 11 , 22, 23, 27, 28) comprise a first and second coupling element (6, 7) protruding from opposite parts of said main body (2), the first and second coupling element (6, 7) comprising at least a first prong (10, 11) elastically mobile both towards said main body (2) and away from said body (2).

5. An oral device according to any of the preceding claims, wherein said releasable coupling means (6, 7, 8, 9, 10, 11 , 22, 23, 27, 28) comprise a first and second coupling element (6, 7, 22, 23) protruding from opposite parts of said main body (2), the first and second coupling element (6, 7) each presenting a respective concave portion designed to engage, when in use, with a respective tooth (105) of said user.

6. An oral device according to any of the preceding claims, wherein at least said main body (2) is made from a material that can be modelled in order to adapt to the shape and size of the oral cavity (101) of said user.

7. An oral device according to any of the preceding claims, wherein said main body (2) comprises an upper portion (12) from which said releasable coupling means (6, 7, 8, 9, 10, 11) protrude and a lower portion (13) hinged to said upper portion (12).

8. An oral device according to any of the preceding claims, wherein said main body (2) comprises at least one filtering portion (5), said filtering portion (5) being shaped to allow, when in use, the passage of liquids such as water and to prevent the passage of said food bolus (B).

9. An oral device according to any of the preceding claims, wherein at least said main body (2) presents rounded edges.

10. An oral device according to any of the preceding claims, wherein said main body (2) comprises a first portion (3) and a second portion (4) engaged with each other, said first and second portion (3, 4) being relatively mobile between a forward position and a retracted position, said oral device comprising means (15) for blocking said first and second portion (3, 4) in a relative position.

11. An oral device according to any of the preceding claims, wherein said releasable coupling means (6, 7, 8, 9, 10, 11 , 22, 23, 27, 28) and said main body (2) are designed in such a way that said main body (2) is positioned in the oral cavity (101) of said user (100) perpendicular to a rear part of the soft palate (106), with its width being correct to fill the palatal arch (104) of the user (100) and its height correct to allow the user to breathe and speak, a lower edge (2a) of said main body (2) being close to the tongue (103) of the user (100) allowing the tongue (103) to move freely.

12. An oral device according to claim 1 , wherein said main body (2) comprises an upper portion (20) and a lower portion (21) forming a single body, said first upper portion (20) and said second lower portion (21) being positioned transversally to each other.

13. An oral device according to claim 12, wherein said upper portion (20) and said lower portion (21) present a concave portion facing, when in use, the exterior of the oral cavity (101) that is to say the opening of the mouth opposite the pharynx (102) of the user (100).

14. An oral device according to claim 12 or 13, wherein said upper portion (20) and said lower portion (21) form a single body, preferably made from elastic material.

15. An oral device according to any of the preceding claims from 12 to 14, wherein at least said main body (2) presents a sharp upper corner (20a) and/or a sharp lower corner (21a).

16. An oral device according to any of the preceding claims from 12 to 15, wherein said releasable coupling means (6, 7, 8, 9, 10, 11 , 22, 23, 27, 28) comprise gripper means (27, 28).

17. An oral device according to any of the preceding claims from 12 to 16, wherein said releasable coupling means (6, 7, 8, 9, 10, 11 , 22, 23, 27, 28) comprise a first and second coupling element (22, 23) protruding from opposite parts of said main body (2), the first and second coupling element (6, 7) comprising a first arm (27) and a second arm (28) and a base portion (26) connecting said first and second arms (27, 28), said first and second arms (27, 28) being elastically mobile so as, when in use, to fit on the (105) and hold the oral device in place.

18. An oral device according to any of the preceding claims from 12 to 17, wherein said releasable coupling means (6, 7, 8, 9, 10, 11 , 22, 23, 27, 28) comprise a first and second coupling element (22, 23) protruding from opposite parts of said main body (2), and shaped to fit over, when in use, a respective rear extremity (107a, 107b) of said upper dental arch (107).

19. An oral device according to any of the preceding claims from 12 to 18, wherein said releasable coupling means (6, 7, 8, 9, 10, 11 , 22, 23, 27, 28) comprise a first and second coupling element (22, 23), said main body (2) comprising a first and second element (24, 25) of engagement for, respectively, said first and second coupling elements (22, 23), said first and second elements (24, 25) of engagement being positioned at opposite ends odf said body (2).

20. An oral device according to any of the preceding claims from 12 to 19, wherein said releasable coupling means (6, 7, 8, 9, 10, 11 , 22, 23, 27, 28) comprise a first and second coupling element (22, 23), said first and second coupling elements (22, 23) comprising at least one coil-wound portion (29).

21. An oral device according to any of the preceding claims from 12 to 20, wherein said releasable coupling means (6, 7, 8, 9, 10, 11 , 22, 23, 27, 28) comprise a first and second coupling element (22, 23), said first and second coupling elements (22, 23) comprising at least one insert (30) to grip a corresponding tooth (105).

22. A kit to control the consumption of food by a user (100) characterised in that it comprises an oral device (1) according to any of the preceding claims and a suction device (201) to suction the food bolus (B) from the oral cavity (101).