WO2017182989A1

WO2017182989A1 - Medication kit adapted to treat lesions of the integumentary tissues

Info

Publication number: WO2017182989A1
Application number: PCT/IB2017/052295
Authority: WO
Inventors: Fabrizio BRACCHETTI
Original assignee: Bracchetti Fabrizio
Priority date: 2016-04-21
Filing date: 2017-04-21
Publication date: 2017-10-26
Also published as: ITUA20162781A1

Abstract

Medication kit, said medication kit comprising a box-like container (10) or case and a plurality of modules (20) shaped as flexible flaps to be affixed on the lesion to be treated, said modules (20) being shaped as anatomic portions of the human integuments and being contained in suitable compartments present in said container (10), said modules (20) being made of materials chemically inert with the human integumentary tissues, or of biocompatible materials and/or bioresorbable materials, said kit being characterized in that each of said modules (20) shaped as flexible flaps has, on at least one of its surfaces, a plurality of incisures having a profile dimensionally complementary and mirrored with respect to that of the collagen fibers and of the reticular fibers of the native extracellular matrix.

Description

"Medication kit adapted to treat lesions of the integumentary tissues"

Description Field of the art

The present invention refers to the medical field. More in detail, the present invention refers to a medication kit for use in the treatment of the lesions of the integumentary tissues caused by burns. Said kit is characterized in that it comprises medications which direct the lesion healing process in a biomimetic manner, limiting the aesthetic damage caused by the lesion as much as possible.

State of the art

The problem relative to the treatment of body lesions, commonly known as burns, caused by heat sources of various nature has been felt since ancient times. Recent findings have also shown that most of the recurring episodes increasingly take place at home, especially involving children and elderly people. The causes of such accidents can often be traced to the poor handling skills of potentially dangerous home objects, and to the ignorance and/or superficial nature of evaluation of the potential burn-causing risk associated with various types of objects of daily use. Hence, if on one hand in recent decades there has been a progressive decrease of accidents encounterable at the workplace due to the increase of adopted safety measures, on the other hand there has been an increase of this accident type in the home, which as stated above mainly involves the elderly and children.

Presently, the treatments for these types of lesions of the integumentary tissues are constantly evolving, with the goal of repairing the damage as much as possible and significantly optimizing the prognosis.

As is known, burns are generally caused by the exposure of the tissue itself to heat sources, chemical substances, electrical sources or radiations. The burns that only affect the first skin layer are defined surface burns or first degree burns; when the damage penetrates into some of the underlying layers, the lesion is termed partial thickness burn or second degree burn; if instead the alteration involves all the skin layers, it is classified as a full thickness burn or third degree burn. A fourth degree burn involves lesions of the deepest tissues such as muscles and bone. The required treatment of course varies as a function of the type of burn, hence as a function of the gravity of the lesion: special alterations can be managed with simple analgesics, while large burns require a prolonged treatment in specialized centers. Usually, the partial thickness burns are diffusely treated by previously executing a cleaning with water and soap, followed by a medication. Burns over the entire thickness usually require surgical treatments, like skin grafts. Extensive burns often require the administration of large quantities of liquids intravenously, since the successive inflammatory response involves a formation of edema and significant losses of capillary fluid.

The most common complications and consequences correlated to burns are tied to infections: immunodepression is always present and underlies the problems of infective type, which occur to the detriment of the burn-affected zones. One then enters into the chronic phase characterized by a considerable reduction of body weight, due to an acceleration of the metabolism, and by hypoproteinemia which can cause functional deficiencies at several vital organs.

Presently, treatment protocols more specifically provide for treating very slight burns (hence first degree burns) with suitable over-the-counter ointments, generally with benzocaine base. In the case of second degree burns, meanwhile, where small blisters are usually encountered - which are not to be removed or punctured - if these are spontaneously opened, the wounds are to be treated by using suitable gauzes containing antibiotic principles, after which one proceeds with the bandaging without compressing the wounds.

In case of more severe burns (third and fourth degree burns), the subject must be admitted as soon as possible in a hospital equipped for emergencies of this type and undergo all the specific treatments for this burn type.

Much statistical data shows that about 95% of burns can be treated at the outpatient level. The objectives of all the treatments comprise a quick healing of the lesions, control of the pain, recovery of the normal functions of the burnt area and a good aesthetic outcome. The latter is undoubtedly one of the desired objectives to be attained, once the risk of compromising burn area functionality has been averted. For such purpose, it is to be considered that in many cases the obtainment of a good aesthetic result depends not only on the type of damage to the tissues, but also on the medications employed during the healing treatments, which as desired must allow the cellular regeneration of the burn-affected parts, preventing the risk of contracting infections and ensuring that the new cellular growth of the tissues occurs in a manner such to reproduce the layers so that they are as similar as possible to those existing before the damage. This condition often depends on the accuracy with which the medications are executed on the patient, and of course on the medication type itself provided by the operators of the field in the aforesaid specialized centers and elsewhere.

However, today experts widely recognize the actual existence of an unsatisfied clinical need for medications for the treatment of all those burns that can create serious skin damage. A treatment is in fact effective for such purpose if it is able to prevent infection, maintain the skin hydrated in order to facilitate the removal of the lesioned tissue, and if it is able to facilitate the regeneration of the tissues in a uniform manner.

It is also indicated that when the lesion is deeper, even touching the dermis below where the stem cells are found, the capacity of the latter cells to regenerate the tissue is also compromised. Consequently, an emergency system is activated which draws stem cells from the adjacent cells, thus involving a considerable increase of the healing time required, as well as the increase of the risk of contracting infections. Even if many deep lesion treatments, in particular the treatment of full thickness lesions, provide for skin grafts for activating the tissue regeneration, it is hard to find effective and accurate medications for the partial thickness lesions. The protocols for this wound type provide for the application of a silver- based antibiotic in order to prevent infection, and they provide for coverage with silicone medications which do not compromise the regeneration of the epidermis during the medication changes. Nevertheless, such material, depending on its thickness, does not always ensure cellular respiration, rendering the hydration process very slow, such process being essential for creating the lesioned tissue layer to be removed.

A recent solution to the problem of the lack of medications which avert aesthetic damage provides for the use of an innovative hydrogel formed by peptides capable of being self- assembled. More in detail, these are oligomeric peptides capable of being assembled in macromolecular nanofiber meshes. Such meshes, having an amphiphilic behavior, are able to trap a considerable quantity of water, up to 99.9%, thus forming a hydrogel that resembles the extracellular matrix. This hydrogel-based structure therefore depends on structural support for the new growth of the cells of the body in a biomimetic manner, and simultaneously acts as barrier against infections.

Other presently known solutions provide for the use of tissue engineering for healing the wounds and regenerating the tissues. The obtainment of such products derives from the awareness of the importance that the extracellular matrix assumes in the processes of cellular regeneration and healing. In particular, the recognition of the importance that the extracellular matrix assumes in the healing processes has led to the development of products such to stimulate or substitute the damaged extracellular matrix.

Among these products of tissue engineering, synthetic or natural collagen matrices are known which mimic the structural and functional characteristics of the native extracellular matrix. Such matrix-like tissues, once introduced in the lesion, provide a temporary scaffolding or support onto which the cells can migrate and proliferate in an organized manner, leading to the regeneration of the lesioned body tissue and finally to the healing of the wound. Such products can be either cellular (hence containing live cells) or acellular (biologically insert) and be of natural or synthetic origin or mixed. Presently, these matrices have use above all in the healing of lesions that are hard to cicatrize, such as venous ulcers of the leg. Even if the use of tissue engineering products always fall within the field of sophisticated and advanced methods for managing complex wounds, the potential disadvantages associated with the use of such materials are the risk of transfer of infective agents and immune reaction. In addition, the processes of production, transport, preservation etc. of these products are quite expensive, consequently involving a limited clinical use. It must also be considered, as stated above, that in the case of body lesions such as burns there are no valid medications and/or instruments which allow applying the medicating substances adapted to prevent infection and facilitate the tissue regeneration in a uniform manner, increasingly seeking to optimize the aesthetic result at the end of the treatment.

For such purpose, the object of the present invention, described in detail hereinbelow, is to overcome the aforesaid critical issues by proposing a kit comprising medications having a surface structure, to be affixed on the burned surfaces, which itself represents a valid mechanical support for facilitating the new tissue growth in a biomimetic manner. The surfaces of the aforesaid medications are for such purpose structured so as to mimic the microstructure of the extracellular tissue matrix in its various depth levels. In such a manner, also the substances conventionally used for the treatment and care of burns can be used. More in detail the kit comprises medications which preferably already comprise, in their structure, the substance/medicine to be administered to the patient.

For the purpose of comprehension of the present industrial invention patent application, it is of interest to report a brief description of the native cellular matrix. As is known, the latter appears as a gelatinous substance comprising a fibrous portion, composed of proteins, included in an aqueous solution of proteins, glycoproteins and proteoglycans. The proteins in question are: collagen, elastin, laminin, fibronectin, chondronectin and osteonectin. More in detail, the extracellular matrix can be divided into: a matrix of amorphous material termed fundamental substance and a fibrillar component. Fibers of the connective tissue are immersed within the amorphous matrix and confer structural stability to the matrix. Such connective tissue fibers immersed in the amorphous substance are separated into three basic types, in accordance with their composition and structure: collagen fibers, reticular fibers and elastic fibers. For the comprehension of the present invention, the collagen fibers and the reticular fibers are of particular interest. Collagen fibers are the fiber type most represented by the human organism and in the connective tissues; on their own, they represent the most abundant non-mineral component after water, constituting up to 6% of the body weight. They appear as long undulated fibers that are branched in two directions (e.g. in the case of loose connective tissue) or in multiple directions (e.g. in the case of regular dense connective tissue), they have a thickness that can vary from 1 to 12 μηι. Each collagen fiber is constituted by dozens of more slender fibrils, with 0.2-0.3 μηι diameter, which determine a longitudinal striation, immersed in an amorphous substance. Each collagen fibril is in turn constituted by micro-fibrils which are longitudinally associated with each other, determining the birefringence thereof. The micro-fibrils, examined under the electron microscope, appear striated transverse to their larger axis; in particular the striations are repeated every 70 nm when wet or every 64 nm when dry, hence they have an axile periodicity of 64-70 nm. Collagen fibers are very resistant to traction, flexible but practically inextensible. The various types of collagen, 29, can be divided into three classes: fibrillar collagen, collagen associated with fibrils and laminar or reticular collagen. Of interest for the following description is the fibrillar collagen class: these are the most common collagen fibers, on their own they constitute nearly all of the collagen of the human body, and collagen of type I, II, III, IV belong thereto. Type I collagen constitutes 90% of the collagen in the body, constituting the bones, tendons, collagen fibers of the dermis and the dentin. Type II collagen is diffused in the cartilage and in the vitreous humor. Type III collagen is diffused in the dermis, in the muscles and in the wall of the blood vessels. Type IV collagen is diffused in the basal membranes.

The reticular fibers, constituted by type III collagen chains, are diffused in the loose connective tissue, in the muscles, in the endoneurium, in the adipose tissue, in the lymphoid organs and in the walls of the blood vessels. They are also constituted by fibrils and micro- fibrils that have axile periodicity of 64-70 nm, but the fibrils are more slender (average thickness of 50 nm) and consequently also the reticular fibers (variable thickness 0.5-2 μηι) are more slender. The reticular fibers are not associated with each to form bundles, but rather constitute thin meshes or weaves, running over two levels or in three-dimensional sense, with wide spaces between the meshes occupying the amorphous matrix. They do not have the longitudinal striation of the collagen fibers. The amorphous substance constitutes a compact gel in which the fibers are immersed. It is essentially constituted by macromolecules of carbohydrate origin termed glycosaminoglycans and from associations of the latter with proteins.

The object of the present invention is therefore to provide a medication to be applied on the body portions damaged by burns which allows tissue regeneration so as to reproduce the native structure of the dermis, thus optimizing the aesthetic result. More in detail, the medications of the kit are supports having a surface on which the incisions are present, defining a profile similar to the complementary profile of the above-described extracellular matrix. On such surface, preferably known curative compositions are extended for the treatment of the burns of the integumentary tissues. More clearly, the object is therefore to ensure that the healing process occurs due both to the pharmaceutical composition and to its mechanical support that "directs" the cells of the dermis to grow to as to reproduce a macroscopic structure that is as similar as possible to that existing before the damage. More in detail, the object of the present invention, described in detail hereinbelow, is to provide new structural supports shaped as scaffolds that allow guiding the cellular growth and reorganization. With respect to the known scaffolds, the modules of the kit are characterized in that they have particular incisures that increase the effectiveness of the scaffold.

Description of the invention

The present description refers to a medication kit for use in the treatment of the lesions of the integumentary tissues and in particular for use in the treatment of burns. Still more in detail the present description refers to a medication kit comprising a plurality of modular and modulatable structures made of specific breathable polymer materials having at least one surface with a micro structure which recalls that of the fundamental (amorphous) substance of the native extracellular matrix. More in detail, the present kit appears as a container shaped as a case in which a plurality of modular and modulatable elements are present, having the profile of anatomic and ergonomic human integumentary portions. Still more in detail, each modular element is represented by a structure made of a biocompatible polymer material or chemically inert and breathable material, which has at least one surface having a microstructure similar to that of the native extracellular matrix present in the dermis. The present medication kit is in particular characterized in that each modular element has the profile of anatomic portions of the human integuments and at least one surface has an amorphous structure, similar to the amorphous substance of the native extracellular matrix, on which the grooves/incisures are present having a profile complementary to that of the collagen fibers and of the reticular fibers of the extracellular matrix, where by collagen fibers preferably the type III collagen fibers present in the dermis are intended. Even the spatial orientation of said grooves is similar and preferably mirrored with respect to that of the aforesaid collagen fibers and reticular fibers present in the native extracellular matrix present in the dermis. In addition, each of the aforesaid modular elements comprises, on said particular surface, a thickness of one of the pharmaceutical compositions conventionally used for healing lesions of the integumentary tissues caused by burns. Before entering into the discussion of the following description of the preferred embodiments, it should be indicated that the materials employed for making the modular structures of the kit are natural or synthetic polymer materials with specific chemical-physical characteristics and properties. More in detail, the materials usable for making said modular structures are, by way of a non- limiting example, degradable polymer materials that lose their structural integrity with dynamics that vary from several weeks to several years in accordance with the interaction between their chemical structure and the environment that hosts them. Preferably, PLA, PGA and PLGA are employed, i.e. alpha-hydroxy esters, or polyesters obtained from the polymerization of alpha-hydroxy acids. These are biocompatible and biodegradable compounds whose degradation products (such degradation occurring via non-enzymatic hydrolysis of the ester bonds in a physiological environment) are compounds with low molecular weight such as: lactic acid and glycolic acid, which enter into the normal metabolic paths, in fact they are normally expelled from the organism in the form of carbon dioxide and water. In addition, PLGA has a wide range of degradation speeds, from days to years in accordance with the ratio of the two monomers and/or of the molecular weight. In addition, in the scope of bioresorbable polymer materials, several polymers of biological origin are to be included, such as alginates, chitosan, hyaluronic acid and collagen. More in detail, the alginates, alginic acid salts, are block copolymers composed of two monosaccharide units: L-guluronic acid and D-mannuronic acid (the regions constituted by blocks of the first acid form hydrogels in aqueous solutions of bivalent cations at room temperature; this characteristic is generally exploited for encapsulating drugs). Chitosan is a polysaccharide derived from chitin and consists of a monometric unit constituted by a relatively simple glucosamine. It is biocompatible and biodegradable. Hyaluronic acid is a linear polysaccharide composed of repeating units of glucoronic acid and N-acetyl glucosamine. By means of an esterification reaction, one can obtain a semi- synthetic biopolymer with different chemical-physical properties, without however altering the structure thereof. Collagen, a natural component of the extracellular matrix of many connective tissues, and already widely used as support for the adhesion of tissues, facilitates the adhesion, proliferation and cellular metabolism. As anticipated, the present invention consists of a medication kit made, by way of a non-limiting example, with such aforesaid materials, which is characterized in that each of said medications has at least one surface made with such materials but not limited to said materials, on which incisures are present with profile complementary to that of the fibers present in the native human extracellular matrix. In particular, the size of such incisures is complementary and mirrored with respect to that of the type III collagen fibers and of the reticular fibers present in the dermis. Such medications, indicated herein as modules, are therefore innovative scaffolds which are proposed for promoting the organization of the new cellular growth of the lesioned integumentary portion in a more efficient manner with respect to the conventional scaffolds. In addition, each module has the profile of anatomic portions of the human integuments and comprises, on the surface to be affixed on the lesioned zone, a thickness of a drug, typically in ointment form, conventionally used for healing wounds. Thus, the present medication kit is proposed for acting as an instrument that is easy to use and with a consistent effectiveness in the treatment of burns, aiming for the obtainment of an optimal aesthetic result at the end of the treatment. More in detail, the kit allows healing wounds with conventional drugs and executes a fine adjustment in the process of structural growth organization. All this while avoiding the use of sophisticated and costly processes for encapsulating drugs, growth factors and/or cells. Still more in detail, the present medication kit, due to the action of the drug previously spread on the surface of the module to be affixed on the lesion, effectively induces the healing process, preventing the risk of infection onset, and due to the microstructure of the surface below the drug layer it allows executing a fine adjustment of the cellular reorganization in a biomimetic manner. Thus, said medications of the kit in primis allow effectively treating the lesions and subsequently allow making possible the obtainment of an optimal aesthetic result at the end of the treatment, due to the innovative scaffold below the layer of drug that acted. It is also of interest to indicate that the modules representing the medications of the present kit are made with materials that preferably have properties such as: biocompatibility, hence non-toxicity together with the capacity to interact with the immune response of the organism, facilitating tissue cell growth and development mechanisms; ability to be biodegradable and/or bioresorbable, for which it should be considered that the time of degradation of the materials constituting the scaffolding must be strictly coordinated with that of the formation of the new tissue so that the overly quick degradation of the matrix does not allow the formation of a complete and strong tissue, while overly long times induce the formation of tissue around the scaffold in an imperfect or incomplete manner. Particular importance was also given to the macrostructure and microstructure of the scaffolds with the intention of promoting the proliferation of the cells and the production of a matrix, specific for the cells, which should replace the role of the scaffold after the degradation of the latter. Also the porosity of the scaffolds was defined with the intention of allowing the diffusion of the nutrient substances and the elimination of the waste. In particular, the scaffolds of the present kit and hence the modules of said kit preferably have dimensions of the surfaces of the pores comprised between 20 and 150μιη. The materials of the modules of the kit can also be easily processed, allowing the manufacturing thereof reproducible on an industrial scale, and they can also be sterilized without there being processes of degradation. The techniques used for making the materials of said modules of the kit are known techniques such as: fiber bonding; electro spinning; microsphere sintering; solvent casting-particulate leaching; phase separation; solid freeform and others.

In order to obtain the particular micro structure and nanostructure of the surfaces, i.e. in order to obtain incisures with profile similar to the complementary profile of the fibers of the extracellular matrix of the dermis, an instrument can be used that is provided with a movable micrometer and nanometer needle. Brief description of the drawings

FIGURE 1 shows an exemplifying view of some of the components of the medication kit for the treatment of the lesions of the integumentary tissues, object of the present industrial invention patent application.

More in detail, the figure in question shows the profile of several of the modules 20 comprised in said kit. The figure intends to show in particular that each module 20, structured shaped as flexible flap, has a profile shaped as anatomic portions of the human integuments. In particular, the figure in question shows modules 20 with profile similar to that of integumentary portions of the face, of the thoracic back, of a limb such as a forearm, a thumb or an abdomen.

FIGURE 2 shows an exemplifying representation of the surface 20' characterizing each module 20 of the present medication kit. More in detail, the figure in question intends to show that said kit is characterized in that each of the modules 20 comprised therein has a surface 20' having a plurality of incisures (fig. 2(a)). In particular: first longitudinal incisures 20", second longitudinal microincisures 20"' defining a system of striated longitudinal bands; and third incisures 20"" oriented shaped as thin meshes and weaves. The goal of such structure of the surface 20' of each module 20 is to define a scaffold with guide incisures that are, both respect to size and space, as complementary as possible to the type III collagen fibers and reticular fibers of the native extracellular matrix. All this in order to facilitate the process of healing the lesion in a biomimetic manner. Figure 2(b) instead shows a front view of a portion of the thickness of a module 20. More in detail the figure in question intends to show that on the surface 20' of the module 20, a film 30 is present of variable thickness of a common medicine adapted for the treatment of lesions of the integumentary tissues caused by burns.

FIGURE 3 shows an exemplifying perspective view of the container 10 shaped as case adapted for containing the modules 20 of the present kit. More in detail, the figure in question shows that said container 10 comprises a plurality of compartments, each adapted for containing at least one module 20. The figure under examination also refers to a particular embodiment in which said container 10 shaped as case comprises a sterile scalpel 40 and a layer of flexible and chemically inert material shaped as mat 50 adapted to offer abutment to said modules 20, if it is of interest to further modulate said modules with the aid of the scalpel 40 in order to render them as adaptable and extensible as possible on the surface of the human integument affected by the lesion.

Description of the preferred embodiments

In all embodiments thereof, the medication kit for the treatment of lesions on the integumentary tissues, object of the present industrial invention patent application, comprises a box-like container 10 or case and a plurality of modules 20 shaped as flexible flaps to be affixed on the lesion to be treated. More in detail, said kit comprises a plurality of modules made of materials chemically inert with the human integumentary tissues, or of biocompatible materials and/or bioresorbable materials. By way of a non-limiting example, said materials are represented by: alpha-hydroxy esters, i.e. polyesters obtained from the polymerization of alpha-hydroxy acids such as PLA, PGA and PLGA, or block copolymers such as the aforesaid alginates, or more simply amorphous polymers such as EPR rubbers. As mentioned several times above, the present kit is substantially characterized in that each of said modules 20 shaped as flexible flaps has, on at least one of the surfaces and in particular on the surface 20' to be affixed on the anatomic portion affected by the lesion, a structure having a plurality of incisures 20" having a profile dimensionally complementary to that of the collagen fibers and of the reticular fibers of the extracellular matrix, and in particular dimensionally complementary to the type III collagen fibers. More clearly, both the orientation/distribution of said incisures 20' on said surface 20' and their size are as mirrored as possible with respect to that of the aforesaid native fibers. The technical effect deriving from such characteristic is to promote a tissue regeneration in a biomimetic manner, with an even finer adjustment than that associated with known scaffolds.

In its preferred embodiment, the medication kit for lesions of the integumentary tissues comprises a plurality of modules 20, each having a surface 20' on which first longitudinal incisures 20" are present with a width of their transverse section comprised between 1 and 12 μηι. Preferably, within each of said first longitudinal incisures 20", second longitudinal microincisures 20"' are present having a width of the transverse sections comprised between 0.2-0.3 μηι. Said first longitudinal incisures 20" and second longitudinal microincisures 20"' define a system of striated longitudinal bands. In addition, said second microincisures 20"' are repeated on each of the surfaces 20' of each module 20 with an axile periodicity of 64-70 nm. On said surface 20' of each module 20, third incisures 20"" are also present, shaped as thin meshes and weaves. In order to render each module breathable, each of these has pores having a surface area comprised between 20-150 μιη .

As already mentioned, each of said modules 20 has a film adsorbed on the surface 20' thereof; such film of variable thickness is a common medicine adapted to treat lesions represented by burns. Preferably, said medicine is in the form of an oil/unguent or ointment or foam. By way of a non-limiting example, in one of its embodiments, on the surface 20' of each module 20, a film 30 of an ointment is present with the following composition:

8% to 10% of a decoction based on thyme, elderberry and mallow; 40% to 45% of soybean oil; 23% to 29% of hydrophilic emulsifying emollient with base of C12-C13 alcohol lactate and/or polyglycerols, 0.7% to 1.4% of benzocaine; 0.08% to 0.3% of colloidal sulfur; 2% to 6% of benzyl alcohol; 0.3% to 0.9% of sodium borate; 0.07% to 0.5% of calcium hydrate; 0.07% to 0.5% of calcium iodide; 0.05% to 0.4% of potassium iodide, 0.01% to 0.05% of thiosulfate. The film 30 of said medicine is also preferably covered with a film of chemically inert material that is if necessary removed.

In all embodiments thereof, the present medication kit comprises a plurality of modules 20 which have, as stated above, the profile of anatomic portions of the human integuments. By way of a non-limiting example, shaped as the integumentary tissues of face portions, of limb portions, of thorax portions, etc. Nevertheless, in order to enhance the versatility of the present kit, each of said modules 20 is further modulatable in a manner so as to allow its adaptation to the lesioned portion as a function of the extension of the lesion, which can even be relatively small. For such purpose, said kit is preferably provided with at least one sterile scalpel 40 and with a layer of chemically inert and sterile material shaped as flexible mat 50 on which it is possible to extend the module 20 that one intends to cut in order to obtain a particular profile thereof, by means of the use of said sterile scalpel 40. If requested, such operation occurs by extending the module 20 on said sterile and flexible mat 50, in a manner so as to affix on the latter the surface opposite the surface 20' of the module 20. Subsequently, with the aid of the scalpel, the profile is defined which the module 20 must assume for its optimal adaptation on the lesion. Then, one proceeds with the removal of said film from the medicine layer adsorbed on the surface 20' and finally setting the module 20 and in particular said surface 20' on the lesion. The modules 20 of the kit can be arranged within the container 10 shaped as case, and provided with suitable compartments, also in bent shape. In fact, the fine adjustment of the lesion healing process, aimed for obtaining a satisfactory aesthetic result, occurs as the final step of the healing process. Indeed it is assumed that the lesioned subject was first subjected to a prior curative treatment, in primis aimed to prevent the risk of infection by following standard first aid protocols. The medicinal film has essentially curative function, preferably to be performed however after the actuation of a previous standard protocol for the treatment of the burns, so that the possible bent shape of the module does not comprise the outcome of the treatment. The latter is in fact related to the aforesaid structure of the surface 20' of each module, on which the medicine is adsorbed in a manner so as to penetrate said incisures, ensuring that the final step of the healing process occurs in a biomimetic manner.

In all embodiments thereof, the medication kit preferably comprises a container 10 shaped as a refrigerator case. In addition, in order to facilitate the use in identifying modules 20 of interest, each compartment has at least one indication such as a label or the like indicating the module 20 type, with the profile of specific anatomic portions of the human integuments contained in the compartment(s). For the same purpose, also said modules 20 can have indications such as writing, numbers or figures adapted for the recognition thereof, and the container 10 can also comprise an illustrative key or sheet that illustrates how to identify and use said modules 20 and in general the present kit.

Claims

Medication kit, said medication kit comprising a box-like container (10) or case and a plurality of modules (20) shaped as flexible flaps to be affixed on the lesion to be treated, said modules (20) being shaped as anatomic portions of the human integuments and being contained in suitable compartments present in said container (10), said modules (20) being made of materials chemically inert with the human integumentary tissues, or made of biocompatible materials and/or of bioresorbable materials, said kit being characterized in that each of said flexible flap-like modules (20) has, on at least one of its surfaces, a plurality of incisures having a profile dimensionally complementary and mirrored with respect to that of the collagen fibers and of the reticular fibers of the native extracellular matrix, each of said modules (20) having - on its surface (20') to be affixed on the lesion to be treated - first longitudinal incisures (20") having a width of their transverse section comprised between 1 and 12 μιη, each of said first longitudinal incisures (20") having, at its interior, second longitudinal microincisures (20"') having a width of the transverse section comprised between 0.

2- 0.3 μηι, said first longitudinal incisures (20") and said second microincisures defining a system of striated bands, said second longitudinal microincisures (20"') being repeated on each of said surfaces (20') with an axile periodicity of 64-70 nm, said medication kit also being characterized in that each module (20) has, on said surface (20'), pores having a surface area comprised between 20-150 μιη , said medication kit also being characterized in that on each of said surfaces (20'), a film (30) is present, of variable thickness, of a common medicine adapted to treat lesions of the integumentary tissues represented by burns.

Medication kit according to the preceding claim characterized in that the modules (20) comprised in said medication kit are made of materials such as PLA and/or PLGA or of block copolymers such as alginates or of amorphous polymers such as EPR rubbers

3. Medication kit according to any one of the preceding claims characterized in that the medicine of the film (30) present on the surface (20') of each module (20) is an oil/unguent, or an ointment or a foam. 4. Medication kit according to the preceding claim characterized in that the medicine of the film (30) present on the surface (20') of each module (20) is an ointment comprising: 8% to 10% of a decoction based on thyme, elderberry and mallow; 40% to 45% of soybean oil; 23% to 29% of hydrophilic emulsifying emollient with base of C12-C13 alcohol lactate and/or polyglycerols, 0.7% to 1.4% of benzocaine; 0.08% to 0.3% of colloidal sulfur; 2% to 6% of benzyl alcohol; 0.3% to 0.9% of sodium borate; 0.07% to

0.5% of calcium hydrate; 0.07% to 0.5% of calcium iodide; 0.05% to 0.

4% of potassium iodide, 0.01% to 0.05% of thio sulfate.

5. Medication kit according to any one of the preceding claims characterized in that the medicinal film (30) present on the surface (20') of each module (20) is covered with a film of chemically inert material that is if necessary removed.

6. Medication kit according to any one of the preceding claims characterized in that the modules (20) are themselves modulatable, said medication kit comprising a sterile scalpel (40) and a layer of chemically inert and sterile material shaped as a flexible mat

(50), on which it is possible to extend the module (20) that one intends to cut, in order to obtain a particular profile thereof, by means of the use of said sterile scalpel (40).

7. Medication kit according to any one of the preceding claims characterized in that the case-like container (10) is a refrigerator container.

8. Medication kit according to any one of the preceding claims characterized in that the case-like container (10) comprises, at each compartment, at least one indication such as a label or the like indicating the module (20) type, with the profile of specific anatomic portions of human integuments, contained in the compartment(s), said modules (20) also having indications such as writing, numbers, figures or the like adapted for the recognition thereof, said container (10) also comprising an illustrative key or sheet that shows how to identify and use said modules (20).

Medication kit according to any one of the preceding claims for use in a method for treating lesions of the integumentary tissues.

Medication kit according to any one of the claims from 1 to 8 for use in a method for treating lesions of the integumentary tissues represented by burns.