EP2785213B1

EP2785213B1 - Disposable device for the treatment of the oral cavity

Info

Publication number: EP2785213B1
Application number: EP12809355.6A
Authority: EP
Inventors: Marisa RONCATI; Lorenzo Vanini; Eugenio Miceli
Original assignee: Micerium SpA
Current assignee: Micerium SpA
Priority date: 2011-12-02
Filing date: 2012-11-30
Publication date: 2019-01-09
Anticipated expiration: 2032-11-30
Also published as: EP2785213A1; ITGE20120052U1; WO2013080177A1; ITGE20110031U1

Description

The present invention relates to a disposable device for cleaning and/or treating the oral cavity.
It is known that cleaning the oral cavity helps the user's wellbeing and it serves for preventing infections to mucosas and/or degenerative diseases of hard tissues of the teeth.
It is known to use gauzes wrapped around the finger or around a tongue depressor soaked in a detergent solution or mouthwash for cleaning teeth, gums and in general for cleaning the oral cavity. Examples are provided by US4335731 and US2005/0262655 .
The individual materials usually used for cleaning, that is toothbrushes, gauzes and mouthwash not always are easily available to the user, for example when he/she is away from home, and certainly they are cumbersome and not very practical to be transported.
Moreover the use of gauzes that are soaked by the user, besides being not very practical, is also not very healthy since this can cause all the liquid solution or the gauze to be contaminated before being used.
The object of the present invention is to provide a cheap device, easy to be used, handy, not very cumbersome, easy to be transported, of pocket size and very healthy and effective in cleaning and/or treating the oral cavity, both for adults and for babies.
A further object of the present invention is also to provide a device suitable for cleaning and/or treating the oral cavity of babies.
These advantages are achieved by a device according to the characteristics of the first claim.
The device has a greater usefulness with respect to known devices for cleaning the oral cavity since it is composed of a piece, that can be wrapped around a finger, impregnated beforehand with a liquid or semiliquid solution or a gel or paste. This avoids gauzes and mouthwashes or the like to be separately transported and this avoids all the preliminary operations for preparing a gauze intended to clean the oral cavity.
According to a preferred embodiment the device is sterilized and/or sterile, and this feature makes it suitable also for cleaning the oral cavity of babies.
Moreover the fact that said device can be packed as individual disposable pieces soaked in one or more substances inside sealed packages to be opened upon the use leads to the advantage that said device is easy to be transported.
Particularly said device can be transported in the hand luggage in the airplane since it allows regulations in force at airports to be overcome, which considerably limit the transport of liquids, toothpastes or the like.
A further advantage of the device of the present invention with respect to known devices for cleaning the oral cavity is that the piece can be wrapped, by a force selected by the user, with one or more turns around a finger, and this characteristic provides a great usefulness, since it allows the device to perfectly fit the dimensions of the finger such to form a whole with the finger, and it allows, by changing the wrapping force and/or the number of turns to adjust the softness or roughness of the device and therefore the cleaning force during the use for hard and/or soft surfaces of the oral cavity.
A further advantage of the device of the present invention is that it is not much expensive and easy to be produced.
These and other characteristics and advantages of the present invention will be more clear from the following description of some embodiments shown in the annexed drawings wherein:

fig. 1 is the device of the present invention at the first step of wrapping it around the finger,
fig.2 is an enlarged detail of the device,
fig.3 is the second step of wrapping the device around a finger,
fig.4 is an intermediate wrapping condition,
fig.5 is the device completely wrapped around the finger and ready to be used,
figs. 6 to 8 are cross sections of different non limiting embodiments of the structural composition of the device,
fig.9 is a first embodiment for packaging the device,
figs. 10 and 11 are a second embodiment for packaging the device.

According to the present invention the device for the treatment of soft and/or hard tissues of the oral cavity, such as tongue, gums, teeth, cheeks, palate comprises a predetermined sized piece 1 made of natural or synthetic fibres, or a mixture thereof, which piece 1 comprises two or more layers of said fibres, the piece 1 being impregnated with at least one liquid or semiliquid substance, in the form of cream, paste or gel for cleaning and/or treating the oral cavity, characterized in that said layers composing the piece are in the form of fabric, nonwoven fabric, two or three- dimensional fibre weaving, cotton wool, fibre mat, cloth or a combination thereof, the piece having two outer layers with meshes with a different size and/or made of different fibres having different flexibility and/or softness and/or size, the said two outer layers providing the piece with one side more rough than the other.
Such as shown in the figures said piece 1 has such a size that it can be wrapped with at least one turn on at least one finger of the user.
According to a preferred embodiment the device is sterile and/or sterilized.
According to a preferred embodiment the piece 1 is disposable.
According to one embodiment the piece 1 is made of sterile or sterilized nonwoven fabric.
These characteristics, particularly the sterility or sterilizability of the device, make the device usable also for cleaning and/or treating the oral cavity of babies.
It is possible to provide in combination with the liquid or semiliquid substance one or more substances for cleaning and/or treating the oral cavity, such as fluoride or the like, in the form of powder, granules or the like.
The size of the piece 1 can change, however according to one embodiment the piece 1 has a size equal to or similar to 19x14 mm.
Preferably the size of the piece 1 ranges from 4x4 to 25x25mm.
Said layer or layers composing the piece are in the form of fabric, nonwoven fabric, two or three-dimensional fibre weaving, cotton wool, fibre mat, cloth or the like or a combination thereof.
The piece 1 can be like a gauze, obtained by the regular weaving of natural and/or synthetic fibres.
According to one embodiment the piece 1 comprises at least one layer of nonwoven fabric.
According to one embodiment the piece 1 is composed of at least one layer of nonwoven fabric composed of 35% polyester and 65% viscose.
One or at least one of the layers composing the piece can be composed of a regular, or substantially regular, weaving of fibres such as a gauze-like layer or the like.
In combination or as an alternative one or at least one of the layers composing the piece can be composed of an irregular weaving of fibres like cotton wool, mat or the like.
Obviously it is possible to provide said piece to be composed of several overlapped layers, equal to each other or of different nature, i.e. layers with regular weaving of fibres and layers with irregular weaving of fibres.
According to the present invention said piece 1 is impregnated with at least one liquid or semiliquid substance for cleaning and/or treating the oral cavity.
The piece 1 can be impregnated with at least one healing substance, such as an antibacterial substance, for treating the oral cavity or at least one sanitizing and/or disinfectant substance, such as a mouthwash or the like or a substance for cleaning and/or washing said oral cavity.
According to one embodiment the piece 1 is impregnated with a solution that does not contain preservatives.
One embodiment of the present invention particularly suitable for cleaning the mouth of babies, provides a sterilized and disposable device composed of one piece 1 impregnated with physiological solution.
The piece 1 composing the sterilized and disposable device can be composed of at least one layer of nonwoven fabric.
These characteristics, that is the use of a sterile and/or sterilized device with a piece 1 impregnated with a preservative-free solution and/or a physiological solution makes the device suitable for treating the mouth of babies since it meets the current national and international laws about devices intended for treating babies.
The sterilization of the device allows preservative-free substances to be used for impregnating the piece 1, consequently allowing the device to be used for cleaning and/or treating the oral cavity of babies.
Obviously it is possible to provide said piece 1 to be impregnated with a mixture of one or more substances in the liquid or semiliquid form, in the form of cream, paste or gel said substances being healing, sanitizing, disinfectant substances and/or having a cleaning or detergent function.
The substance or substances used for impregnating the piece 1 can be sterile.
The amount of the substance used for impregnating the piece 1 changes depending on the size of said piece 1 and/or depending on the material it is made of.
For example it is possible to provide a piece 1 with a size of 19x14 mm composed of 35% polyester and 65% viscose to be impregnated with 3 ml of substance.
It is possible to provide to use from 0.2 to 10 ml of impregnating substance for each piece 1.
According to one embodiment the substance impregnating said piece 1 comprises or it is composed of a physiological solution.
Said physiological solution can be enriched with additives that allow the chemical/physical characteristics of the device to be maintained, such as preservatives, and/or flavouring substances intended to freshen the oral cavity, such as mint extracts or the like.
Said impregnating solution can be composed of mouthwash.
Said impregnating solution can be composed of a mixture comprising water, sodium chloride, sodium benzoate, sodium chloride being provided in an amount ranging from 0.2% to 20%, preferably from 0.7% to 11%, particularly 0.9%.
According to a further embodiment the substance impregnating said piece 1 comprises or it is composed of chlorexidine.
Chlorexidine can be provided in an amount ranging from 0.02% to 3%, preferably from 0.05% to 2%, particularly 0.12%.
The substance impregnating said piece 1 can comprise sorbitol, specially denatured ethyl alcohol, propylene glycol, gluconate chlorexidine polysorbate 20, castor oil ethoxylate 40 moles, anethole, sodium fluoride and flavours.
Even in this case as an alternative or in combination with flavours it is possible to provide the presence of additives that allow the chemical/physical characteristics of the device to be maintained.
Obviously it is possible to provide as an alternative and/or in combination with chlorexidine at least another chemical disinfectant, particularly with antiseptic action.
In order to increase the cleaning action of the piece 1 it is possible to provide the surface of one or more of said layers to be provided with microgranules.
Obviously it is possible to provide the substances having a cleaning action and/or for treating the oral cavity to be not only in a solution or in the form of gel or paste but also to be in the form of powder that impregnates the piece 1.
Such as shown in the figures the use of the device provides the piece 1 to be wrapped, with one or more turns, around the finger of the user, for example the forefinger.
Obviously it is possible to wrap the piece 1 even around a tool such as a tongue depressor or the like.
According to a preferred embodiment such as shown in figures 1 to 5, the piece 1 is wrapped as it follows:

step 1: deploying the piece 1 and placing the finger to be wrapped in the middle of the surface extension of the piece 1,
step 2: overturning the two half-flaps separated by the central folding line of the piece 1 one against the other orienting the finger along said folding line,
step 3: contemporaneously wrapping the two half-flaps folded one against the other around the finger,
step 4: folding the portion extending beyond the tip of the finger, backwardly against the finger.

According to a not shown improvement it is possible on the piece 1 to print by an enhancing colour, the middle area where placing the finger, the middle folding line as at step 2, an arrow indicating the wrapping direction as at step 3, and an arrow for folding the portion projecting beyond the finger as at step 4. Due to this the wrapping becomes evident and the operation is made easier without the need of reading the instructions.
The structure of the piece 1, that is the number and the nature of the layers constituting it, determines the softness and/or roughness of the device, and these characteristics depend also on the force with which the piece 1 is wrapped on the finger.
Once the device is wrapped on the finger, by passing it one or more times in the oral cavity, it can be used for cleaning, disinfecting, treating or healing, more or less delicately, the hard and/or soft tissues of the oral cavity i.e. teeth, gums, tongue, palate, cheeks.
The device therefore allows plaque and other foreign elements in soft tissues, surface of the tooth and tongue, such as food residues to be removed. Moreover it guarantees the oral cavity to be fresh and good smelling.
Particularly a sterile and/or sterilized device composed of a piece 1 impregnated with or soaked in a physiological solution allows a preservative-free device for cleaning and/or treating the oral cavity to be provided and therefore suitable also for cleaning and/or treating the oral cavity of babies.
With reference to figures 2 and 6 to 8, there are shown some embodiments of the material composing the piece 1.
Advantageously at least one layer of said piece denoted by S1 is composed of a loose mesh fabric typical of medicament gauzes.
The loose meshes by the yarn portion of the weaving generate projecting or protruding elements having a brushing function, while the several windings form a mat allowing the treatment substance to be well absorbed and held whether it is a liquid, a cream, a gel or the like.
With reference to figure 6, the piece 1 can be made of several layers (at least two) of mesh fabric overlapped to each other. They can be bound to each other by seams perpendicular to the surface extension of the two layers S1 or by needle punching or due to adhesion effect due to the substance they are impregnated with or soaked in.
The alternative of figure 7 provides at least three layers of which two outer layers made of a loose mesh fabric of the type previously described and therefore denoted even in this figure by S1, while there are provided one or more intermediate layers S2 of fibres which are woven in several ways such as for example as a two-dimensional or three-dimensional fibre mat, cotton wool layer, nonwoven fabric, needle punched fabric or other type of fibre compressing.
In this case the absorption factor of the treatment substance by the device increases and in addition even some softness is given to the device.
The two outer mesh fabric layers can be made integral with the intermediate layer or layers by sewing, needle punching techniques or by adhesion due to the treatment substance the fibre material is impregnated with or soaked in.
According to the invention the two outer layers S1 can have meshes with a different size and hence they can have a different action when removing the stuck material. Moreover, according to the invention, in combination or individually said outer layers can be made of different fibres having a different flexibility and/or softness and/or size. This allows the two outer layers of the device to have different effects when removing the material namely one side more rough than the other side, by means of which it is thus possible to choose the intensity of the mechanical action of the tissues depending in the sensitivity of the tissues to be treated or depending on other needs of the specific case.
Figure 8, not being part of the claimed subject matter, finally shows a further variant providing the mesh fabric layer S1 only on one face of the layer S2 of fibres woven together in several ways for example in the form of a two-dimensional or three-dimensional fibre mat, cotton wool layer, nonwoven fabric, needle punched fabric or other type of fibre compressing.
Even in this case the mechanical effect on biological tissues to be treated by the device is different depending on which of the two faces of the device is brought in contact with the biological tissues.
Obviously it is possible to have also other combinations of fabric layers having different modes of weaving the fibres and a different type of fibre or mixture of fibres as regards the material and the structure of the fibre i.e. short, long and compressed singularized fibre or fibre in the form of more or less coarse or raw thread or yarn.
Advantageously the present disclosure provides the device described above in combination with a transport, sale and storing package that is particularly advantageous, both for the specific use and for its implementation, and which easily allows different quality levels in the packaging as regards the preservation of the device features.
According to one embodiment figure 9 shows a box shaped package 10.
The box can be soft, i.e. pliable or rigid. A pliable box is made of a mono or multilayer sheet suitably folded and formed and joint such to make the box. The rigid box can be made of any material, preferably plastic material such as the boxes for packaging wipes or the like.
In both the cases at one side of the box there is provided an opening 110 for withdrawing a plurality of devices housed in said box 10. These devices can be in the form of single pieces or a continuous tape of material which is divided into single pieces joint one to the other by transverse predetermined rupture tear lines. In figure 9 the tape or the pieces are shown by 20.
The withdrawing opening 110 along the edge has a frame 210 tightly connected to the material of the wall of the box 10 which frame 210 cooperates with a closure lid 310 movable from a closing position to an opening one and vice versa and that in the closed condition tightly engages the frame, preferably by an elastic snap fit or a shape coupling or by friction.
Such embodiment is only an example of the several currently available possibilities for the person skilled in that for making a box of this type and particularly for making a container/dispenser for soaked or impregnated pieces.
Preferably according to the present disclosure at least one or only one soaked or impregnated piece 1 is housed in a closed package openable by the user upon the use.
Said piece 1 closed in the package has such a size that it can be wrapped with at least one turn on at least one finger of the user.
According to the present disclosure thus it is possible to provide the device, comprising a predetermined sized piece 1, impregnated with at least one liquid or semiliquid substance, in the form of cream, paste or gel for cleaning and/or treating the oral cavity, closed in a disposable package.
In particular it is possible to provide each package to undergo a sterilization process and to contain a single piece 1 or a limited number of pieces 1 to be used anytime it is necessary to clean/treat the oral cavity.
Thus the user can open only the package holding the soaked piece 1, when he/she needs to perform the cleaning/treatment.
The process for achieving a sterile and/or sterilized device enclosed in a package, provides the following steps:

inserting at least one piece 1, soaked in or impregnated with at least one liquid or semiliquid substance, in the form of cream, paste or gel, inside a package, such as a bag or the like,
tightly sealing the package,
sterilizing the package, for example by means of several types of radiations and/or by heat.

Preferably each package subjected to the sterilization process contains one piece 1.
Obviously such as described above as an alternative or in combination with the liquid or semiliquid substances, it is possible to use, in order to impregnate the piece 1 , substances for cleaning and/or treating the oral cavity in the form of powder, granules or the like.
The sterilization process can be performed also for cleaning and/or treating devices contained in a box shaped package 10 as the one described above.
The variant embodiment of figures 10 and 11 shows a package, wherein at least one or only one soaked or impregnated piece 1 is housed into a bag 11 tightly closed on all the four sides and provided with a tear opening 111.
Advantageously said package can be of pocket size.
For example it is possible to provide a 9.5x6.5 cm package.
The modes for making the bags are known and widely used for pieces or wipes impregnated with perfume or disinfectant materials. In figures 10 and 11 the pieces 1 is denoted with 21.
In particular the sealing can be achieved by a layer of adhesive sealing material denoted by 112.
The bag can be made of any type of film or mono or multilayer sheet. Depending on needs the sheet or film or only one of said layers can also have a barrier effect for one or more of the following elements: gas, vapours, microorganisms.
As described above after tightly sealing the package it is possible to provide also a sterilization step.
According to a variant it is possible to provide the sterilization of the device and of the package, such to have a sterilized device inside a package preventing the contents of said package from being contaminated or deteriorated.
The packaging techniques are known and used for other types of products such as for example gauzes impregnated with or soaked in disinfectant tissues impregnated with perfume or detergent and so on.
The advantage of such packages is important since it allows the product to be stored for a long time and to be preserved for a long time. During short journeys when due to the known safety regulations, the travellers have small size luggage to be brought with them in the passenger compartment of the airplane, soaked tissues are allows, while as regards liquids and creams in tubes there are regulations in force restricting their amount.
Therefore the present invention relates to a device, structurally simple and inexpensive, for cleaning and/or treating the oral cavity, preferably sterile and/or sterilized, that can be soaked in or impregnated with merely a physiological solution such to allow the oral cavity also of babies to be cleaned, and/or with other solutions, that are more suitable for cleaning and/or treating the oral cavity of children, young men and adults.
Preferably the substance or substances impregnating the piece 1 are in an aqueous solution such that they can be uniformly spread on whole the piece 1.
The piece 1 has such a size that it can be wrapped with at least one turn around at least one finger of the user such that it is up to the user to fit the device to the size of the finger (or the tool having the function of a finger, such a tongue depressor, around which the piece can be wrapped) and/or to choose the softness/rigidity of the device: therefore the cleaning force of the device can be adjusted by the user depending on the type of surface to be treated, soft as the gums, or hard, as that of teeth.
By means of the structure of the piece 1 the release of the solution or of the substance or substances for treating and/or cleaning the oral cavity can take place without applying any force by the user but simply by passing the finger among the soft and/or hard structures in the oral cavity.
This is particularly advantageous when using the device of the present invention for cleaning the oral cavity of babies which is particularly delicate.
As described above the devices used with the babies have to stay within the bounds of specific, particularly restrictive, regulations for the protection of their health and safety.
The device of the present invention is particularly suitable for being used for treating babies since it is sterilized and free of substances potentially dangerous for a baby, it being possible to provide a piece 1 impregnated with a physiological solution or any other solution preferably free of substances not suitable for being administered to babies such as preservatives, compounds based on fluorine or the like.
Particularly the use of the device, as a piece 1 of non-woven fabric impregnated with a solution such as chlorexidine, mouthwash or physiological solution, allows what follows to be obtained in combination one with the other:

an abrasive/soft action for removing the plaque without damaging the soft tissues,
an optimal distribution and/or release and/or application of the solution on a wide area of the mouth by merely rubbing the finger of the user.

Preferably the piece 1 is stored within a tightly sealed package and which can be opened by the user upon the use of the disposable device such that the chemical/physical characteristics of the disposable device and/or the sterility remain unchanged over time till it is used.
The present disclosure relates also to a kit for cleaning and/or treating soft and/or hard tissues of the oral cavity, such as tongue, gums, teeth, cheeks, palate, which kit comprises one or more packages like a bag or the like, such as those shown in figures 10 and 11, containing at least one device as described above and as claimed.
The present disclosure relates also to a kit for cleaning and/or treating soft and/or hard tissue of the oral cavity, such as tongue, gums, teeth, cheeks, palate, which kit comprises one or more packages like a box or the like, such as the one shown in figure 9, containing at least one device as described above and claimed.
The invention is not restricted to the embodiments described above but changes and/or modifications can be made to the device without departing from the inventive concept described and claimed.

Claims

Disposable device for cleaning and/or treating soft and/or hard tissues of the oral cavity, such as tongue, gums, teeth, cheeks, palate, the device comprising a predetermined sized piece (1) made of natural or synthetic fibres, or a mixture thereof, which piece (1) comprises two or more layers of said fibres, the piece (1) being impregnated with at least one liquid or semiliquid substance, in the form of cream, paste or gel for cleaning and/or treating the oral cavity
characterized in that
said layers composing the piece (1) are in the form of fabric, nonwoven fabric, two or three-dimensional fibre weaving, cotton wool, fibre mat, cloth or a combination thereof,
the piece (1) having two outer layers with meshes with a different size and/or made of different fibres having different flexibility and/or softness and/or size, the said two outer layers providing the piece (1) with one side more rough than the other.
Device according to claim 1 characterized in that said piece (1) has such a size that it can be wrapped with at least one turn on at least one finger of the user or on a tool having the functions of a finger, such as a tongue depressor or the like.
Device according to claim 1 or 2 characterized in that said device is sterile and/or sterilized.
Device according to one or more of the preceding claims, characterized in that said piece (1) is composed of at least one layer of nonwoven fabric composed of 35% polyester and 65% viscose.
Device according to one or more of the preceding claims, characterized in that said piece (1) is impregnated with a mixture of substances in the liquid or semiliquid form, in the form of cream, paste or gel said substances being healing, sanitizing, disinfectant substances and/or having a cleaning or detergent function.
Device according to one or more of the preceding claims, characterized in that the substance impregnating said piece (1) comprises or it is composed only of a physiological solution.
Device according to one or more of the preceding claims, characterized in that the substance impregnating said piece (1) comprises or it is composed of a preservative-free solution.
Device according to one or more of the preceding claims, characterized in that said impregnating solution is composed of a mixture comprising water, sodium chloride, sodium benzoate, sodium chloride being provided in an amount ranging from 0.2% to 20%, preferably from 0.7% to 11%, particularly 0.9%.
Device according to one or more of the preceding claims, characterized in that the substance impregnating said piece (1) comprises or it is composed of chlorexidinein an amount ranging from 0.02% to 3%, preferably from 0.05% to 2%, particularly 0.12%.
Device according to one or more of the preceding claims, characterized in that the substance impregnating said piece (1) comprises sorbitol, specially denatured ethyl alcohol, propylene glycol, gluconate chlorexidine polysorbate 20, castor oil ethoxylate 40 moles, anethole, sodium fluoride and flavours.
Device according to one or more of the preceding claims, characterized in that the piece (1) is impregnated with or soaked in at least one sterile liquid or semiliquid substance or solution.
Device according to one or more of the preceding claims, characterized in that the surface of one or more of said layers composing the piece (1) is provided with microgranules facilitating the cleaning of the oral cavity.
Device according to one or more of the preceding claims, characterized in that as an alternative or in combination with the liquid or semiliquid substance, one or more substances for cleaning and/or treating the oral cavity are provided, such as fluoride or the like, in the form of powder, granules or the like.
Device according to one or more of the preceding claims, characterized in that the size of the piece (1) ranges from 4x4 to 25x25mm.
Device according to one or more of the preceding claims, characterized in that it is provided in combination with a package like a bag or the like, which bag is tightly sealed and it is tear openable and which bag contains at least one of said device being said bag made of impermeable material or at least non-breathable material and it is made of at least one mono or multilayer sheet or film, with at least one layer with barrier effect towards gases and/or liquids and/or microorganisms.
Device according to claim 15, characterized in that said bag is made of a mono or multilayer sheet or film or it has at least one layer composed of a sheet or film impermeable to microorganisms, said at least one piece (1) being sterilized after tightly sealing said piece (1) into said package.
Device according to one or more of the preceding claims 1 to 14, wherein two or more pieces (1) are housed in a package provided with means closing an aperture for grabbing said pieces (1).