ITUB20150266A1 - Tissue regeneration apparatus. - Google Patents

Description

DESCRIPTION

of the industrial invention entitled:

Tissue regeneration apparatus

The present invention relates to an apparatus for tissue regeneration.

Skin alterations are a real clinical-care problem of growing importance. For example, ulcers (venous ulcers, arterial ulcers, diabetic ulcers, pressure ulcers or bedsores) are often disabling, as they are mostly localized. at the level of the lower limbs. In recent years the problem has assumed increasing importance, especially as a consequence of the progressive increase in the population in age? advanced and therefore of the prevalence of chronic disabling diseases. In addition, burns and wounds of the skin in general put the emphasis on the need? to find devices to assist the skin healing process and minimize the chances? of wound infections.

US 70565326 B2 discloses an adhesive tape for medical use comprising a strong adhesive layer for long-term applications on human skin. Said adhesive tape can? be provided with a pharmacological preparation for the percutaneous absorption of the drug. The application of the adhesive tape can? occur on both healthy and damaged tissue. The device only creates a barrier to prevent infection of a possible wound, but it does not act by assisting the repair of the wound.

US 7989165 B2 describes a non-invasive method for detecting, monitoring and diagnosing dermatological pathologies such as skin irritations and psoriasis. The method includes the use of an adhesive tape for the detection of one or more of the epidermal cells. predictive markers of a dermatological pathology.

US 20050192631 A1 discloses a suture tape consisting of interwoven surgical suture materials. One edge of the ribbon extends the full length of the ribbon. At the center of the tape there is a second interweaving of surgical fibers that allows the suture to be anchored to the tape, acting as a support for the suture and allowing the two edges of the patient's wound to be brought together.

US 20100298747 describes a tape for applications in the kinesiology field comprising a first adhesive side suitable for being applied to the skin and a second suitable non-adhesive side comprising in turn a longitudinal cut.

US 20130300100 A1 discloses an adhesive tape for medical use comprising a risk indicator. Said risk indicator can? report the presence of dangerous conditions during medical procedures such as the presence of needles and sharp or the presence of pathogens in the patient's blood.

Purpose of the present invention? that of having an apparatus suitable for applications in the medical field, in particular for interventions adjuvant to tissue regeneration of the skin.

An additional purpose? that of having an apparatus for innovative medical use to create the micro environmental conditions that an injured tissue needs for regeneration.

An additional purpose? that of having a medical apparatus capable of facilitating the functionality? of advanced dressings, to act as an adjuvant to clinical protocols already? in use in the hospital and on the territory.

Another purpose is to have an apparatus for medical use to activate tissue regeneration without causing micro damage to the tissue itself as occurs with other methods (eg laser fraxel, acoustic waves).

Still a purpose? that of obtaining an apparatus for tissue regeneration that does not involve the introduction of active substances such as growth factors or stem cell implants.

Still a purpose? that of having a medical apparatus for tissue regeneration that is transportable to the bed of patients who are in a non-transportable condition.

Further purpose? that of having a tissue regeneration apparatus equipped with disposable accessories capable of stimulating healing even between treatment sessions.

Still a purpose? to have an apparatus with technologies that act in synergy to improve healing times to improve quality? of patients' lives and to reduce healthcare costs.

In accordance with the invention this purpose? achieved with a medical apparatus applicable to injured tissues characterized by the fact of comprising an electromechanical device and a fixing device, called electromechanical device? adapted to be connected to an apparatus for the generation of vacuum and to be fixed to the patient's tissue by means of the fixing device, said electromechanical device comprises at least one plate fed and crossed by electric current and provided with an insulating coating, a plurality of of anti-UV filter lenses and metal plates comprising at least one LED.

These and other characteristics of the present invention will be made clearer by the following detailed description in an example of its practical embodiment illustrated by way of non-limiting purposes in the attached drawings, in which:

Figure 1 shows a top plan view of an enclosure of an electromechanical device;

Figure 2 shows a side view of the electromechanical device;

Figure 3 shows a bottom plan view of the electromechanical device; Figure 4 shows a sectional view of the electromechanical device according to the line V-V of Figure 2;

Figure 5 shows a top plan view of an adhesive tape;

Figure 6 shows a bottom plan view of the adhesive tape;

Figure 7 shows a top plan view of the electromechanical device and a fastening device;

Figure 8 shows a side view of the electromechanical device and of the fastening device;

Figure 9 shows a side view of a data acquisition device; Figure 10 shows a sectional view of the device for data acquisition according to a line X-X of Figure 9;

Figure 11 shows a sectional view of a device for data acquisition according to a line XI-XI of Figure 10;

Figure 12 shows a diagram of the main functions of a software.

The medical apparatus 1 comprises an electromechanical device 2, a fixing device 3, a device for acquiring patient data 4 and software 5 for data management and therapy optimization.

The electromechanical device 2 comprises a support casing 211, metal plates 26 with insulating cover 231, filter lenses 221 and plates with LEDs 27, temperature detecting and modulating devices (Figures 1, 3 and 4).

The support casing 211 includes a flat base 213 and a cap 212. The cap 212 of the support casing 211 has one or more. holes 21 suitable for allowing the connection between the support casing 211 and a device for generating the vacuum 23. The cap 212 comprises pegs 22 suitable for interacting with the fixing system 3. An internal portion 230 of the flat base 213? suitable for housing two types of structures: a metal plate 26 with insulating cover and a filter lens 221 with plates with led 27 above.

The metal plate 26 comprises a flat base 213 suitable for being applied on the internal portion 230 and metal anchors 217 to anchor the metal plate 26 to the flat base 213. Said metal plate 26? powered and traversed by current. The electromechanical device 2? provided with two different types of metal plates 26: one fed by a simple resistor 218 and one by a solenoid 219. Said metal plate 26? provided with an insulating coating 231 suitable for thermally insulating the patient's skin from the metal plate 26 which overheats during use. The coating 231 can? be composed of ceramic material or amber or polymers designed to withstand high temperatures such as Polyimides, Polyphenylensulfides, Fluoric polymers, Polyaryletherketones and Polyarylsulfones (Figure 3 and 4).

The resistors 218 or the solenoids 219 are powered by sinusoidal current or simply connected to a cathode of the external power supply. The sinusoidal current will have? the characteristics of low power and high frequency waves: from 3 Mhz to 65 Mhz. In addition, the plate 26 can? also deliver a square wave with similar characteristics. In the case of resistances connected to the cathode sar? there is a plate connected to the anode. This plate will go? positioned under the ulcerated flap on the other side of the ulcer in order to create a condensing effect.

The metal plates 26 can detect the temperature of the fabric with which they are in contact. The metal plates 26 represent resistances, one or more? of these can? be used as a resistance of a temperature measuring circuit. The temperature detection system? based on the initial temperature difference between injured and periwound tissue. The detection of temperatures? useful for detecting the temperature of the injured and periwound tissue before (initial delta T) and during treatment (delta T during treatment); so ? It is possible to calibrate a maximum threshold of delivery of the electric current through the metal plates 26 in order not to excessively increase the body temperature in the treated tissue. The internal portion 230 of the flat base 213 of the electromechanical device 2 comprises anti-UV filter lenses 221 and other plates with LEDs 27. The structure comprising the filter lenses 221, the plates with LEDs 27 and the metal plates 26? arranged in the internal portion 230 of the flat base 213 on two levels.

A first level of the structure comprises the metal plates 26 alternating with the anti UV rays filter lenses 221; the metal plates 26 are joined to the filter lenses 221 with rubber joints 220 adapted to allow the metal plates 26 to be mutually movable in order to adhere also to concave surfaces. Said first level of the structure? adapted to be put in contact with the patient's skin by means of the flat base 213. The plates with LEDs 27 comprising the LEDs are arranged on a second level. These LEDs mounted on the plates with LEDs 27 are of two different types: one with a wavelength of 405-420 nm (nanometers) and the other with a wavelength of 850-900 nm. These LEDs have a power of 7-12 Watts. Said second level? adapted to be placed at a distance of 1-3 cm from the patient's skin in order to obtain an intensity? similar to that of 400 W lamps placed 25 cm away from the patient's skin (Figure 4).

A fastening device 3 comprises an adhesive support 30 of rectilinear shape, for example a tape. Said fastener 3? adapted to interact with the mechanical device 2 so as to be fixed to the patient's skin. The adhesive backing 30? in elastic fabric in the direction of the length of the tape, but static in the sense of the height of the tape. Said fastener 3? composed of two different types of yarns: in the warp a polyurethane-based elastomer covered with a polypropylene fiber, while in the weft? made of polyester. Coating the elastomer can? be single or double, allowing you to adjust the elasticity? elastomer according to the different application needs.

The particular polyester fiber used for the weaving of the adhesive supports 30? designed to create a thermal barrier in order to raise the temperature of the area of interest and to promote its healing.

The fastener 3? adapted to adhere to the patient's skin thanks to the application of a hypoallergenic acrylic glue.

The fixing device 3 provides two areas of different application of the hypoallergenic acrylic glue: an internal 32 totally adhesive with a height of 1 cm and an external 33 with partial adhesion. The totally adhesive area 32 overhangs a flap of the wound, has holes 31 suitable for coupling with the fixing pins 22 present on the casing 211 of the electromechanical device 2 (Figures 5 and 6). The arrangement of the glue? suitable to guarantee the possibility? to create a stable negative pressure over time. The totally adhesive zone 32 is fixed to the electromechanical device 2 while the partial adhesion zone 33 is applied to the patient's skin and ensures the fixing of the electromechanical device 2 (Figures 7 and 8).

As shown in Figure 9, the data acquisition device 4 comprises at least one chamber 42 which can be in color and in high definition (HD), at least one LED including a diffuser 45, at least one infrared thermometer 44 for detecting the temperature both on the area to be treated and in the surrounding areas, laser projectors 43 which allow correct framing of the targets, the connection cables 46. The device for data acquisition 4? connectable to an electronic interface, for example a computer, and further comprises the software 5 suitable for receiving data from the data acquisition device 4, for carrying out an objective analysis of what has been learned and for recording the processed data in an archive.

The structure of the device 4 contains, making it a single piece, all the components necessary for the activity? of data collection.

The data acquisition device 4 comprises an ergonomic handle 41, a casing 431 and a dome diffuser 432 of transparent material to allow data acquisition.

In the casing 431 of the data acquisition device 4 there are the cables 46 which connect the data acquisition device 4 with the hardware / software interface comprising ethernet cable, power supply cable and I / O signal management cable.

The cables 46 are contained within a single flexible tube 47 made of flexible material, for example rubber, shielded and connected to an attachment 49 designed to be compatible with a set of devices of the same type but with different characteristics (Figure 10).

The data acquisition device 4 can? have different shapes according to the application: for example, to analyze wounds on the sole of the foot it must have certain dimensions and different technical characteristics in case it is necessary to analyze larger surfaces. extended.

The handle 41, according to the final application, can? present different shapes in order to guarantee a firm and comfortable grip according to the area to be treated.

As shown in figure 10, the instruments for data acquisition are housed inside the data acquisition device 4, anchored to the casing 431 and facing the dome diffuser 432 of the data acquisition device 4. The chamber 42 is located in the center of the envelope 431 and? surrounded by the laser projectors 43. In the area adjacent to the laser projectors 43 there are the infrared thermometers 44. The instruments contained in the casing 431 are protected from the outside by the dome diffuser 432 to avoid the accumulation of debris, dust or bodies strangers that could fall or lodge in the wound compromising the photographic shot; while maintaining the possibility? effective cleaning.

The area of the data acquisition device 4 containing all the components? directly connected to the ergonomic handle 41.

The dome diffuser 432 of the casing 431 comprises a silicone cushion 460 designed to prevent rubbing from causing any lesions in the patient's skin and to be able to adhere completely to the irregular surface.

The internal part of the data acquisition device 4 houses the LED bands 45 suitable for illuminating the target area; the domed structure? suitable for obtaining indirect lighting (Figures 10 and 11).

The lighting is carried out indirectly and interposed with the dome diffuser 432 in order to obtain a homogeneous lighting (diffuser) by reducing any reflections (indirect light) as the angle of incidence of the light would not bring out any shiny areas of the injury compromising the data to be analyzed as it is homogeneously distributed on the target.

The software 5? designed to collect information and store it in a database accessible at any time for consultation and updating of this data. In particular, the software includes the following functions: data collection 51, analysis proposal 52, data query 53, insertion of macro entities? patient / cases / treatment and medicines / devices 54, the generation of a unique patient code 55, the comparison of the sample with previous analyzes 56 (Figure 12).

As regards the operation of the electromechanical device 2? designed to be positioned over the injured part of the skin, coming into contact with the latter. The adhesive supports 30 are adapted to be fixed to the patient's skin in the periwound area, so that the internal portion 32 of the totally adhesive adhesive support 30 overlaps the electromechanical device 2. The pegs 22 present on the casing 211 of the electromechanical device 2 are suitable to be inserted in the holes 31 present on the fastening device 3 in order to make it even more? firmly fix the electromechanical device 2 to the patient's skin.

An external device 23 for generating vacuum can? be connected to the electromechanical device 2 through the hole 21 in the casing 211 of the electromechanical device 2.

The negative pressure generated will go? to help approach the edges of the wound, stimulating the healing of the same in a protected environment.

Because of this ? It is necessary for the fixing device 3 to guarantee constant air tightness to the electromechanical device 2, and for it to be securely connected, preventing any movement thereof that would preclude the correct performance of the therapy.

The fastener 3? capable of generating a mechanical? lifting force? of the fabric to be treated; the fixing device 3 fixes the electromechanical device 2 to the patient's skin, which, connected to an external device 23 to generate the vacuum, allows the injured tissue to be lifted. Said lifting allows the fabric to adhere with the metal plates 26 which supply electric current, the contact of the fabric with the metal plates 26 allows the treatment of the injured area.

The fastener 3 can? be adjusted: increasing the tension of the tapes 30 of the fastening device 3 increases the lifting of the fabric.

The lifting given by the fastener 3 can? amplify the lifting effect of the tissue from the periphery to the center by improving blood and lymphatic vascularization.

The target skin is not? subjected to a vacuum treatment, therefore it differs from all the patented systems for obtaining the vacuum.

The electromechanical device 2? able to obtain, thanks to its peculiar electrical energy, a controlled thermal rise without harming the tissue and even bringing it up to 44-45 ° C transcutaneous (localized therapeutic hyperthermia) In a variant of the device? It is possible to modulate the transcutaneous therapy while operating by rapidly lowering the temperature (even in the time of 30 seconds) to 22-23 ° C transcutaneous.

? It is also possible to obtain the phenomenon of cryophoresis if you want to penetrate the target active substances more? smoothly.

During the therapy, the technologies act in a combined way giving a synergistic effect. The different forms of energy can also be used simultaneously on the injured tissue for example mechanical force, temperature modulation, photobiomodulation and electric current. At the end of the hospital therapy, the electromechanical device 2 fixed with the fastening device 3 to the patient's skin can? be left on the patient's skin in order to continue the therapy with the only mechanical energy that will approach? the edges of the wound helping to heal.

Before starting the therapy and after each therapeutic cycle, the operator can? acquire patient data, including the temperature of the lesion and the periwound area and the state of wound healing, through the data acquisition device 4. Said data acquisition device 4 allows the operator to position himself on the lesion in a precise point thanks to to the laser projectors 43 which guide the operator and record the exact position in which the acquisitions are made, at the next acquisition the data acquisition device 4 will be able to do so. be repositioned in the same position recorded in the previous analysis. The temperature is detected thanks to the infrared thermometers 44 to avoid a too high rise in the temperature of both the lesion and the periwound area. Room 42? suitable for acquiring images and videos of the patient's tissue.

The software 5? able to collect 51 all the data to perform and propose 52 objective analyzes based on the elements collected by the external device 4 and also allows to query 53 the data in order to obtain purely personal information, both at a statistical level, for example the average duration of treatment for a case of ulcer in position X with patient of age? Y.

The software 5? designed on the idea of a client / server architecture. Said software 5? designed to exchange data both via TCP protocol within a company LAN, and via encrypted protocol via webservice.

The architecture makes it possible to manage, in complex cases, an infrastructure with a centralized database, devices installed in the same structure (LAN), devices installed in satellite structures such as clinics or detachments located in different geographical positions and finally devices? Unit? mobile? located in different geographical locations with operators acting at home.

The insertion, management and maintenance of information in the database can? be done manually or automatically.

This allows, for example, that once the data concerning a treatment have been entered manually? Information can be automatically generated to be sent to third party software such as an Enterprise Resource Planning (ERP) to proceed with billing.

The application provides, for security reasons, the management of access levels with the assignment of privileges in order to enable or disable certain functions.

Access and privilege management? managed not by a single user, but by groups of users in order to streamline maintenance; this function? synchronizable with company domain and Active Directory, if present, in complex structures.

Within the digital system, every operation both in the insertion phase and in the maintenance / updating of the data? recorded in an archive so that it can be consulted for audit trail purposes.

The software 5? designed to manage macro-entities? Patient, Case, Treatment and Medicines / Devices 54.

The software 5? designed to associate with each member of an entity? a unique code 55 for better information management

A practical example? applicable to infrastructures with pi? analysis stations, whether they are fixed or home stations. ? It is possible to generate identification codes containing information relating to the station used for the specific treatment.

This logic allows information to be indexed in order to streamline its maintenance and availability.

The software 5? designed to manage every member of an entity? through the assignment of a state that determines the conditions of validity? within the system; the assignment of a state? only possible if all conditions for the assignment are met.

The Patient / Customer database? the section of the software dedicated to the management of the entity? ? Patients ?, in this section? It is possible to register all sensitive personal data relating to the patient.

Each field and data present within this registry can? be used for statistical or research / filter purposes.

For example ? It is possible to generate a report of all patients residing in the same area, or having the same age.

Cases registry? the section of the software 5 dedicated to the management of the entity? ? Cases ?; in this section? it is possible to record and manage all the data relating to a clinical case of a patient; the patient data becomes necessary and binding information for the presence of a Case.

Within this section it will be? presented the overall clinical picture with the data relating to the evolution of the case.

The Cases database therefore includes the census of a case from its first evaluation and follows its developments over time, showing the information of all the visits made and comparing the data collected.

Any data present in this section? subject to statistics, for example? It is possible to generate an analysis report relating to all cases relating to a specific area of the body, or that have shapes or sizes of a certain type.

The Case Management has a section dedicated purely to the personal data census of the case and an analytical section that contains graphs and information on the progress.

The section ? designed to propose comparative data between the first census and subsequent treatments, presenting graphs and evidence on the settings of the treatment performed, the therapy and the medication adopted.

To correctly register the data it will be? It is possible to use manual insertion, the external capture device described above and voice recognition, via microphone.

Manual entry will allow? to record non-visual data but related to sensations or senses that cannot be defined with the current level of technology, for example the patient's perception of pain.

Entering the data? made interactive, where possible, in order to speed up and better define the registration method.

? It is possible to use the data acquisition device 4 for the collection of evidence on which to formulate objective data.

After having found the ideal position for the framing of the target, the 5 software will receive? a series of data that will go? to analyze and propose? on the user interface, recording in the database not only the analysis and the numerical data, but all the evidence collected.

The software 5 will be able to? report and propose only objective data, for example dimensions, depth, conditions of the periwound skin, temperature.

Once proposed, the data will remain? awaiting modification and validation by competent personnel before being definitively registered.

On the screen, the system proposes the captured image with the analysis relating to the size of the lesion and the total size, including the periwound area; effective area and total area; depth, volume; evaluation of exudate; evaluation of the condition of the periwound tissue and the possible presence of foreign bodies.

Through the image captured by the device, the digital system proposes a 3D reconstruction of the analyzed surface; the 3D object? navigable, scalable and rolling.

Next to the analysis there are parameters and selectors to be able to correct and modify the analysis proposed by the software 5 without having to repeat the learning process.

The image on which to develop the analysis? importable not only by means of the previously described data acquisition device 4, but also manually.

The entity? ?Treatment? ? directly connected to a Case and therefore inherits a large part of the personal information of the Reference Case.

In this section the software 5? designed to record patient and wound condition data and annotations prior to treatment, during treatment and at the end.

The parameters set on the electromechanical device 2 and any notes, dictated to the software 5 via the microphone, regarding details during the therapy will also be recorded.

Finally, the names of the devices / medicines / medicaments and the quantities will be noted? used for advanced wound dressing.

The modalities? of recording are the same used for the census of the Case at the first insertion: manual, through the data acquisition device 4, through a microphone.

The database of medicines and devices for advanced treatment / medication? present in software 5 so as to be able to provide more details and information relating to the treatment applied to the patient.

This type of information within each individual treatment makes it possible to verify and manage the use of the material and its effectiveness. For instance ? It is possible to generate a report per drug in order to obtain graphs indicating its use.

The software 5? designed to learn and improve the assessments proposed in the analysis and forecasting phase on the therapy cycle.

Once the samples have been captured by means of the data acquisition device 4, the software 5 compares the sample to be analyzed with the analyzes performed on similar cases previously evaluated 56.

For example, tissues that are not initially recognized as a periwound area because of an unacceptable color or shape, are subsequently interpreted as possible recognizable areas.

In the same way, the system proposes therapeutic cycles, medical device settings or medicaments, based on the experience gained on all registered and analyzed therapy cycles.

Within the application? there is a statistical section which allows you to compare the collected data and export a report or generate a data flow addressed to third-party software.

In this section? It is possible to compare and filter the information by crossing them and statistically any data present.

Alternatively, the fixing device 3 comprises a tape, a tape or an adhesive support of circular shape according to the area of the skin to which it is to be applied.

Alternatively, the electromechanical device 2 comprises at least one valve for the calibrated introduction of gas, for example nitrogen, into the area undergoing treatment. In the area subjected to depression, it is possible to create a rapid cooling thanks to the presence of vacuum with a system such as? vacuum cooling ?.

Advantageously, the apparatus allows to create the micro environmental conditions, through different forms of energy that can also be used simultaneously on the treated tissue (mechanical force, temperature modulation, photobiomodulation, electric current) that the tissue needs. , to activate tissue regeneration, without giving a micro damage as happens in other regenerative methods (eg laser fraxel, acoustic waves) and without the need? to introduce active substances such as growth factors or stem cell implants; however, the invented method is also suitable as an adjuvant to therapies of active substances in the tissue. An added benefit? given by the possibility? to leave the fixation device and the electromechanical device applied to the patient's skin for a longer time. long compared to traditional therapies as the application of the apparatus does not require a vacuum system. Still a plus or? given by the fastening device which anchors the electromechanical device to the skin, preventing its displacement even following movements of the patient.

Another advantage comes from the patient data acquisition device which allows to process and archive the evolution of the lesion and healing.

Still an advantage? given by the patient data acquisition device which allows to detect and archive images of the lesion as well as to obtain information about the skin temperature and the positioning of the detected image with respect to the patient's body.

Another benefit? given by the software that allows you to archive, catalog and reprocess all patient data and also allows you to optimize the therapy and settings of the electromechanical device.

An additional benefit comes from the 5 software which? able to allow a statistical analysis of the patient and the evolution of the lesion based on the therapy used.

Claims (10)

CLAIMS 1. Medical apparatus (1), characterized in that it comprises an electromechanical device (2) and a fixing device (3), called electromechanical device (2)? adapted to be connected to an apparatus for the generation of vacuum (23), said electromechanical device (2) comprises at least one plate (26) fed and crossed by electric current and provided with insulating coating (231), a plurality of of filter lenses (221) and plates with led (27). 2. Medical apparatus (1) according to claim 1, characterized in that an internal portion (230) of a support casing (211) of the electromechanical device (2) comprises a structure arranged on two levels, a first level comprising the plates metal plates (26) alternating with the filter lenses (221) and a second level comprising the plates with LEDs (27), said metal plates (26) being joined to the filter lenses (221) with rubber joints (220) designed to allow the metal plates (26) to be mutually movable to adhere even to concave surfaces. Medical apparatus (1) according to claim 1 or 2, characterized in that the support casing (211) of the electromechanical device (2) comprises a flat base (213) and a cap (212), said cap ( 212) includes one or more? holes suitable to allow the connection of the electromechanical device (2) with the apparatus for the generation of vacuum (23) and of the pins (22) able to interact with the fixing device (3). 4. Medical apparatus (1) according to claims 1-3, characterized in that the LEDs of the plates (27) of the electromechanical device (2) are of two different types, a first type with a wavelength of 405-420 nm and a second type of LED with a wavelength of 850-900 nm, both types of LEDs have a power of 7-12 Watts. Medical apparatus (1) according to any one of the preceding claims, characterized in that the insulating coating (231) of the plate (26) of the electromechanical device (2)? composed of ceramic material or amber. Medical apparatus (1) according to any one of claims 1-4, characterized in that the insulating coating (231) of the plate (26) of the electromechanical device (2)? composed of polymers designed to withstand high temperatures such as Polyimides, Polyphenylensulfides, Fluoric polymers, Polyaryletherketones and Polyarylsulfones. Medical apparatus (1) according to any one of the preceding claims, characterized in that the fastening device (3) provides adhesive supports (30) of two different types of yarn, in the warp a polyurethane-based elastomer covered with a propylene fiber , while in the weft a polyester, said propylene fiber can? be single or double to adjust the elasticity? of the elastomer. 8. Medical apparatus (1) according to claim 7, characterized in that the adhesive supports (30) of the fixing device (3) comprise two areas of different application of a hypoallergenic glue, an internal area (32) totally adhesive suitable for be fixed to the electromechanical device (2), and an external area (33) with partial adhesion. 9. Medical apparatus (1) according to any one of the preceding claims, characterized in that it comprises a device for data acquisition (4) connectable to an electronic interface and comprising at least one chamber (42), at least one LED illuminator ( 45), at least one infrared thermometer (44) and a plurality of of laser projectors (43). 10. Medical apparatus (1) according to any one of the preceding claims, characterized in that it comprises a software (5) able to perform and propose objective analyzes and settings of the electromechanical device (2) and to propose therapeutic cycles based on the data collected on all the cases recorded and analyzed previously.