IT202000006427A1 - MEDICAL DEVICE IN THE FORM OF A PATCH APPLICABLE ACCORDING TO A PLURALITY OF METHODS FOR THE TREATMENT OF PAIN, IN PARTICULAR INFLAMMATION, THROUGH HEAT AND METHOD TO TREAT PAIN, IN PARTICULAR INFLAMMATION, THROUGH HEAT USING THIS MEDICAL DEVICE - Google Patents

Description

DESCRIPTION

of the patent for industrial invention entitled:

? MEDICAL DEVICE IN THE FORM OF A PATCH APPLICABLE ACCORDING TO A PLURALITY OF METHODS FOR THE TREATMENT OF PAIN, IN PARTICULAR INFLAMMATION, THROUGH HEAT AND METHOD TO TREAT PAIN, IN PARTICULAR INFLAMMATION, THROUGH HEAT USING THIS MEDICAL DEVICE?

Technical field

The technical field of the present invention? that relating to medical devices in the form of patches configured to have a therapeutic effect on users in the event of a state of pain in progress, for example in the case of inflammatory processes or other circulatory or muscular pathologies in progress. In particular, the technical field of the present invention refers to medical devices in the form of patches not containing drugs or active ingredients which are released and absorbed by the user during the treatment. In detail, the technical field of the present invention relates to medical devices in the form of a patch configured to treat pain, in particular inflammation in the user, by means of heat. Further in detail, the technical field of the present invention refers to medical devices known as? FIR patches ?, ie patches that use the user's body as a source of heat for the treatment, in particular the electromagnetic waves belonging to the far infrared emitted by the ?user.

State of the art

As indicated in the previous chapter, the technical field of the present invention refers to a medical device in the form of a patch configured to have a therapeutic effect on users in the event of a painful or altered state in progress. As specified, the treatment provided? a treatment not through drugs or active ingredients but through heat and preferably, but not limitedly, the therapeutic effect offered can? relate to the treatment of inflammatory processes or circulatory or muscular pathologies.

Today medical devices in the form of patches of this type (heat treatment) and offered to the public for the purposes listed above (in particular treatment of inflammatory processes) are widespread on the market. This diffusion derives from the justified importance of countering the inflammatory mechanisms which are nothing but manifestations of degenerative pathologies in progress in the human being. In fact, if not treated properly, these inflammatory processes can lead to the onset of chronicity. of the same. Such chronicity? ? absolutely to avoid why? it often leads the organism into a state of oxidative stress with consequent production of unstable and reactive molecules which cause tissue degenerative phenomena capable of triggering potential alterations of serious entities. The spread of such medical devices in the form of heat-treated patches? further enhanced by the fact that drug research currently does not? able to propose alternative solutions able to effectively deal with inflammatory and / or oxidative phenomena. Incidentally, it is emphasized that, both for the purposes of the present invention and as regards the known art, the term? Patch? it must not be understood in a restrictive way but on the contrary with this term we mean a support that can be worn in various ways to deliver your treatment. In fact, for the purposes of the present invention by patch is not meant? necessarily a device to be applied directly on the skin of the user and, as in the known art, can? find application in the form of supports that can be worn in various ways, for example in the form of a band, insole or other. Of course, also in these embodiments suitable characteristics are provided for guaranteeing the correct positioning of the medical device.

What about heat treatment of inflammation? today it is known that the use of energy sources, such as heat, represents a valid method compared to traditional medical devices, that is, those which, carrying out a therapeutic action, release pharmacological substances on the area of the body subject to the treatment. Currently, medical devices in the form of patches for the treatment of pain by heat can be divided into two categories. The first concerns those patches or wearable supports that also incorporate the heat source that activates the treatment. In particular, such devices usually comprise a plurality of of heating cells originally isolated from the surrounding environment by means of a film to be removed before use. Only after the removal of this film the heating cells are activated (usually by chemical reaction activated by the contact with the air of the cells themselves) and provide heat for a predetermined duration of time. There are many disadvantages associated with this first type of heating patches. Leaving aside the complexity? and the cost connected to the realization of the heating cells and to their correct maintenance in non-active form before use, one of the major disadvantages consists in the very limited duration of the treatment which forces the user to frequently replace the patch no longer? active. Another disadvantage of these heating patches lies in the way in which the heat treatment is delivered. In fact, especially during the first phases of activation of the heating cells, the heat produced? strong enough to make the treatment painful and impractical for users even if they are not particularly sensitive.

A second type of heating patches, a type to which the medical device of the present invention belongs, provides for the use of a source other than heating elements embedded in the patch to be activated before use as a heat source for the therapeutic treatment. In particular, in this second type the heat source of the treatment corresponds to the user of the device himself. This curative method in fact makes use of the energy emitted by the user's body appropriately used for the purposes of the treatment. In particular, these medical devices are configured to intercept the (thermal) energy emitted by the user and reflect or redirect it towards the user himself. The thermal energy reintroduced into the user's tissue acts on the organic tissues involved in inflammatory processes and in states of oxidative stress. From a technical point of view, the energy emitted by the user's body is radiation due to the thermal agitation of the molecules, as primary constituents of the cellular macrostructures, following the absorption of solar radiation which causes an increase in temperature and, therefore, an increase in thermal energy (each body at a temperature above 0 K radiates electromagnetic energy). Further technical details about both this phenomenon of emission of radiation from the human body and its use for therapeutic purposes are not further described here. known to those skilled in the art. Wide? in fact, the literature, patent and non-patent, on these topics.

Am I incidentally? It is possible to mention that in the field of therapeutic applications, the absorbed and emitted electromagnetic waves of greatest interest belong to the far infrared (? Far Infrared ?, or FIR in the continuation). FIR radiations with a wavelength between 4 and 20? M promote molecular phenomena of vibrational type (for example? Streching? And? Bending? Vibrations of the water molecule) and show a greater penetration power in the human body, reaching depth? up to 6-7 cm with respect to the external surface of the epidermal layer. Given the abundance of water in the human body (about 70%),? It is important to underline the mechanism of action triggered by the interaction between FIR radiations and water molecules: FIR radiations penetrate living tissues and are absorbed by water molecules, so they are activated. vibrational movements that break up the anomalous and harmful clusters of water molecules (such as clusters of up to 200 water molecules) avoiding cell death and restoring the water molecules to their ideal state of 2-3 aggregated molecules. In addition to the advantageous disintegration of water clusters,? known the beneficial mechanism of action of FIR radiation on the so-called? microcirculation ?. Indeed, the small arterial vessels (thickness of the walls of about 6? M), as well as? their capillaries, cos? like blood blocking devices (DEB) that regulate blood flow in small vessels, they have dimensions compatible with FIR radiations and when hit by such radiations they trigger a resonance phenomenon. For example, the DEB stimulated by FIR radiations activate, due to the effect of resonance, specific vibrational motions that free the blood vessel from partial occlusion due to an irregular functioning of these DEBs, thus allowing the vascular lumen and blood to completely supply. all the capillaries of the microcirculatory system. AND? a further and advantageous mechanism of action triggered by FIR radiations is known, involving the Fibroblasts, used, among other things, for the production of collagen and connective tissue. The beneficial effect of the aforementioned mechanisms of action activated by the interaction of FIR radiations with the human body has stimulated the development of a technology that allows to take advantage of the FIR radiations emitted by the human body, reflecting them and promoting their reabsorption in the human body. organism using the principle of therapeutic heat. Among the most reflective principals? known and used in this context, Titanium Dioxide (TiO2) emerges. In fact, TiO2 belongs to the category of chemical compounds capable of having a high reflectance power for FIR radiation. Also, TiO2? easily workable even in large quantities? on a large scale and cost-effective. As an example, in the thick patent documentation on the subject of FIR patch? citable the utility model? IT202016000108124 which describes a medical device, in various configurations including that of a patch, in which the Titanium Dioxide, designed to reflect the FIR radiations emitted by the body, is mixed together with the pigments during the molding of a graphic element shown on the patch. On the one hand, this realization offers the advantage that the user has immediate feedback and control of the area affected by the treatment but nevertheless does not? free from disadvantages.

A first disadvantage? linked to the quality? of the treatment offered by these patches. In fact, in these patches the Titanium Dioxide (or the material or substrate reflecting the FIR emitted by the user) is found in an intermediate or even external layer of the patch (as in IT202016000108124) and this position greatly reduces its effectiveness in terms reflectance for FIR radiation.

Furthermore, a second disadvantage occurs when the user has sensitive skin or the part affected by the treatment is a very sensitive part of the body. In this case, in fact, a problem connected with this device according to IT202016000108124 and with other medical devices known as FIR patches? related to the need? to make the therapeutic device adhere in direct contact with the skin in the vicinity? of the inflamed part of the body and this modality? application necessarily limits their use over time. In fact, the direct and prolonged contact of these patches often causes unpleasant side effects such as skin irritation and redness limited to the area of application, often due to a lack of transpiration of this part of the body due to the occlusion of the pores of the skin. Due to this exclusive and limited use, sensitive subjects, such as, for example, children and the elderly, tend not to favor this therapeutic device for the treatment of inflammatory diseases.

Finally, the traditional FIR therapeutic patches are marketed with predefined shapes, thus restricting the areas of application of the patch on the body. For example, a large, contoured shaped patch? suitable to be coupled only to certain specific areas of the user, for example a? lumbar? but not ? adaptable to an inflammatory pathology at the knee level.

Description of the invention

Starting from this technique, an object of the present invention is known? that of providing a medical device in the form of a plaster for the treatment of pain, in particular inflammation, by means of heat capable of overcoming the aforementioned drawbacks of the known art. In particular, the purpose of the present invention? to create a medical device in the form of a patch for the treatment of pain, in particular inflammation, by means of heat, the use of which can? be prolonged over time and have an optimal treatment efficacy. How will it emerge, in virtue? of its particular conformation, the medical device of the present invention provides a plurality of of different alternative ways of application, each of which guarantees the effectiveness of the treatment.

In accordance with these purposes, the present invention? relating to a medical device in the form of a patch for the treatment of pain, in particular inflammation, by means of heat. The medical device? in the form of a multilayer patch, preferably perforated, and in this sense comprises the following layers:

- a first layer made of polymeric non-woven fabric, preferably polypropylene, comprising a first face and a second face;

- a second layer made of adhesive material comprising a first face coupled to the second face (or internal face) of the first layer and a second face; in other words, the adhesive layer is laid down during the steps of making the patch on one face of the first layer;

- a removable film coupled to the second face of the second layer to be removed before using the medical device and which has the purpose of preserving the capacity? adhesive from the free face of the second layer before using the patch.

Hence, a sectional view of the patch before use shows three overlapping layers with two outer layers, i.e. the first layer made of non-woven fabric and film, and an inner layer made in the form of an adhesive layer.

Preferably, all of the aforementioned layers have the same extension so? that in each point of the patch there is the aforementioned overlapping of layers.

In particular, the above described patch of the present invention? configured to perform pain treatment (preferably inflammation) via heat where however the heat source for treatment? the user himself. In fact, the patch of the present invention? configured to be a so-called? FIR? or ? configured to reflect towards the user part of the electromagnetic waves belonging to the far infrared emitted spontaneously by the user himself. This type of treatment and its positive aspects are already? known to the person skilled in the art (see chapter? prior art?) and therefore are omitted here for simplicity? exhibition.

To accomplish this capability, the patch of the present invention (as well as all the known patches with FIR technology) comprises a chemical compound configured precisely to reflect towards the user at least part of the far infrared radiation (FIR) emitted spontaneously by the same user. .

The main and innovative aspect of the present invention resides in the particular position of this chemical compound part inside the multilayer patch described above and precisely this innovative solution allows to use the patch according to a plurality of materials. of different modalities? of application all effective in terms of pain treatment. Well, according to the main aspect of the present invention, the chemical compound configured to reflect towards the user at least part of the far infrared radiation (FIR) emitted spontaneously by the same user? dispersed in the second layer, i.e. in the adhesive or glue state.

This solution is innovative in several respects. The first ? the fact that this solution is not? at all suggested by the prior art which provides to drown the chemical compound in a layer pi? internal even in the layer pi? outside of the patch opposite the adhesive layer. The second lies in the fact that having drowned the chemical compound in the glue, the chemical compound fulfills its capacity? reflexive whether the patch? applied directly to the skin, both if? there is an intermediate layer between the adhesive layer and the skin. This innovative application (which, as you will see, can be declined in at least two different ways) broadens the audience of potential users of the device to include also? Sensitive? such as subjects with delicate skin, children, pregnant women or others.

Naturally, both the choice of the chemical compound and its characteristics in terms of particle size, weight per square meter and molar mass are extremely important factors in order to guarantee correct treatment. The Applicant has conducted numerous tests on this file in virtue of of which the choices fell on the following parameters.

Preferably the chemical compound? a compound based on (or substantially composed of) Titanium Dioxide (TiO2).

Preferably the titanium dioxide particles have a particle size between 1 µm and 20 µm.

Preferably, the TiO2 particles have a grammage per square meter of the second layer in the range between 1 g / m2 and 20 g / m2.

According to another relevant aspect of the invention, the chemical compound? homogeneously dispersed in the second adhesive layer. Although this characteristic may seem of minor importance, this choice goes against the trend of the known technique according to which the FIR patches on the market today have clear evidence of the areas of the patch where? the chemical compound is present and in the areas where there is no active treatment. Thanks to the homogeneous presence of the chemical compound throughout the adhesive layer? possible to foresee the marketing of patches with a? neutral? that is, patches that, starting from a common starting shape, can be used for many different applications. In fact it will be? it is sufficient to partially cut into the patch to shape it as desired without incurring the risk in the portion of patch used there is not an inactive portion.

As indicated above, the medical device of the present invention not only? innovative for the effectiveness of the treatment offered in general, but it? also for the capacity? to offer different modalities? of use to better meet the different types of users.

The basic method or methodology for treating pain, in particular inflammation, through the present invention comprises the steps of:

a) providing a medical device as claimed in claim 1 or as described above;

b) remove the film;

c) apply the medical device in correspondence with the area of the user to be treated.

Starting from this general definition, and in virtue? of the fact that the chemical compound? drowned in the glue layer, at least three different modalities can be identified? of use with the same excellent treatment efficiency.

The first way of use involves a? Direct application on the skin in which the aforementioned phase c)? then performed by applying the second face of the second layer directly on the user's skin.

A second and third way provide for the presence of an intermediate body (different from the skin) to support the patch in position

So a second way? of use, the aforementioned phase a) also provides for the presence of an intermediate body facing the user's skin which acts as a support for the medical device and phase c)? performed by applying the second face of the second layer on the intermediate body in such a way that the intermediate body is interposed between the second layer and the user's skin. According to an application example of this second method? It is possible to apply, for example, the patch on the outer face of an undergarment (undershirt or underpants or similar) so? that the glue is not applied on the skin but on the garment between the glue and the skin. Even if in that realization there? an intermediate layer, the presence of the chemical compound immediately beyond this barrier allows in any case to obtain an excellent treatment.

A third mode? application always provides for the presence of the intermediate layer for? this time the patch does not? applied on the outer face of this layer but on the inner face. In this case ? the first layer of the patch itself that stands between the adhesive and the skin. Also in this case, the presence of the chemical compound immediately beyond the first layer allows to obtain an excellent treatment. An application example of this third modality? it could be foresee the patch in the form of an insole in which the glue is used to bind the device inside the shoe. The presence of a sock as a further intermediate layer does not entail any decay in terms of treatment efficacy.

Description of an embodiment of the invention Further characteristics and advantages of the present invention will become clear from the following description of a non-limiting embodiment thereof, with reference to the figures of the annexed drawings, in which:

? figure 1? a perspective view of an embodiment example of a medical device according to the present invention;

? figure 2? an enlarged view of the detail indicated in Figure 1 with the reference II;

? figures 3-5 show three different modes? of use of the device of figure 1;

? Figure 6 shows a second example of embodiment of a medical device according to the present invention.

With reference to the attached figures, figure 1 shows a perspective view of an embodiment example of a medical device according to the present invention. In particular, this example shows a medical device 1 in the form of a patch 2 of rectangular shape for the treatment of pain, in particular inflammation, by means of heat. How can patch 2 be seen? a multilayer patch comprising the following layers:

- a first layer 3 made of polymeric non-woven fabric comprising a first face 4 and a second face 5;

- a second layer 6 made of adhesive material comprising a first face 7 coupled to the second face 5 of the first layer 3 and a second face 8;

- a removable film 9 coupled to the second face 8 of the second layer 6 to be removed before using the medical device 1.

As schematized, in the second layer 6? dispersed a chemical compound 10 configured to at least partially reflect far infrared radiation (FIR) so that when the medical device 1? used by a user at least part of the far infrared radiation (FIR) emitted by the user's body? reflected towards the user himself. Figure 2 shows an enlarged view of the detail indicated in Figure 1 with the reference II in order to have a better view of the layers mentioned above.

Figures 3-5 show three different modes. of use of the device of figure 1. In figure 3? shown a first mode? of use of the patch 2 in which the second face 8 of the second layer 6 (glue)? directly applied on the skin 11 of the user 12. The figure 4 shows a second modality? of use of the patch 2 in which the second face 8 of the second layer 6 (glue) applied on an intermediate body 13 which is found between the glue 6 and the skin 11 of the user 12. In this embodiment, the intermediate body 13 can? be a garment worn next to the skin by the user. Figure 5 shows a third mode? of use of the patch 2 in which the second face 8 of the second layer 6 (glue) applied on an intermediate body 13 in such a way that the first layer 3 is found between the glue 6 the skin 11 of the user 12 the intermediate layer can be the same garment as in the previous example or a support of a different nature, such as for example an inner sole of a shoe.

According to this last possibility, figure 6 shows a second example of embodiment of a medical device according to the present invention in which the plaster 2 is shaped in the form of the insole and the adhesive layer 6? configured to be applied inside a shoe so? that the first layer is placed between the glue layer and the user's skin. As can be seen in this example, the first layer includes indications such as guides or invitations to cut so that? the user can easily shape the patch according to their foot size.

Finally, it is evident that modifications and variations can be made to the invention described here without departing from the scope of the attached claims.

Claims (10)

CLAIMS 1. A medical device in the form of a patch for the treatment of pain, in particular inflammation, by means of heat; the medical device (1) being a multilayer patch (2) comprising the following layers: - a first layer (3) made of polymeric non-woven fabric comprising a first face (4) and a second face (5); - a second layer (6) made of adhesive material comprising a first face (7) coupled to the second face (5) of the first layer (3) and a second face (8); the medical device (1) further comprising a removable film (9) coupled to the second face (8) of the second layer (6) to be removed before use of the medical device (1); characterized by the fact that in the second layer (6)? dispersed a chemical compound (10) configured to at least partially reflect far infrared radiation (FIR) so that when the medical device? used by a user (12) at least part of the far infrared radiation (FIR) emitted by the user's body (12)? reflected towards the skin (11) of the same user (12). Medical device as claimed in claim 1, wherein the chemical compound (10) comprises Titanium Dioxide (TiO2). Medical device as claimed in claim 2, wherein the chemical compound (10)? homogeneously dispersed in the second layer. 4. Medical device as claimed in claim 3, in which Titanium Dioxide particles have a particle size between 1? M and 20? M. 5. Medical device as claimed in claim 3 or 4, wherein the TiO2 particles have a grammage per square meter of the second layer in the range between 1 g / m2 and 20 g / m2. Medical device as claimed in any one of the preceding claims, wherein the medical device (1) has a neutral shape and comprises on the first face (4) of the first layer (3) and / or on the film (9) guidelines (13) to the cut to allow the user (12) to shape the medical device (1) from the neutral shape to a specific use form. 7. Method of treating pain, especially inflammation, by heat; the method including the steps of: a) providing a medical device (1) as claimed in claim 1; b) remove the film (9); c) apply the medical device (1) in correspondence with the area to be treated on the skin (11) of the user (12). 8. Method as claimed in claim 7, wherein step c)? performed by applying the second face (8) of the second layer (6) directly on the skin (11) of the user (12). 9. Method as claimed in 7, in which step a) also provides for the presence of an intermediate body (13) facing the skin (11) of the user (12) which acts as a support for the medical device (1), the step c)? performed by applying the second face (8) of the second layer (6) on the intermediate body (13) so that the intermediate body (13) is interposed between the second layer (6) and the skin (11) of the user (12 ). 10. Method as claimed in 7, in which step a) also provides for the presence of an intermediate body (13) facing the skin (11) of the user (12) which acts as a support for the medical device (1) , step c)? performed by applying the second face (8) of the second layer (6) on the intermediate body (13) so that the first layer (3) is interposed between the second layer (6) and the skin (11) of the user (12 ).