IT201600103357A1 - ELECTRO-OPTICAL DEVICE, IN PARTICULAR FOR DERMATOLOGICAL APPLICATION - Google Patents

Description

"ELECTRO-OPTICAL DEVICE, IN PARTICULAR FOR

DERMATOLOGICAL APPLICATION "

FIELD OF APPLICATION

The present invention relates to an electro-optical device, in particular for dermatological application.

In particular, the present invention relates to a "dermospectroscope".

The "dermospectroscope" instrument has the purpose of providing the dermatologist or even the general practitioner with diagnostic indications by means of spectrometric analysis of skin lesions, providing data on the probability of pathological alteration for the area of skin examined.

TECHNIQUE NOTE

For melanoma, as with all other cancers, the earlier the diagnosis, the better the prognosis. Considering the significant epidemiological impact of skin neoplasms, the development of effective in vivo diagnostic tools to support clinical diagnosis is of great interest. New techniques for detecting pigmented and non-pigmented skin lesions, especially non-invasive diagnostic tools, are currently being studied in numerous laboratories. In daily clinical practice the most commonly used instrument is the manual dermatoscope, the more restricted is the use of the videodermatoscope.

Dermoscopy represents an important advance in the diagnosis of skin cancer. It is a non-invasive technique that allows a 10 to 40 times magnification of the observed lesions and eliminates the effects of reflection and refraction of light, allowing the analysis of structures that are not visible to the naked eye. This method significantly increases the diagnostic accuracy compared to the simple clinical evaluation. The cost of an instrument of a few hundred Euros for the basic models allows a wide use of the instrument both in hospital and outpatient settings. The devices currently available allow an image acquisition of the new formation without however providing an automatic quantitative and qualitative analysis.

Limited to a few centers and mostly for research purposes is the use of a more sophisticated tool such as optical coherence tomography (OCT), confocal microscopy and some types of spectroscope for ex vivo and in vivo examinations.

Optical Coherence Tomography (OCT) is a recent imaging technique that has very similar operating principles to ultrasound. The difference lies in the type of signal used as a reference: the OCT in fact exploits the phenomena of reflection, by specific tissues, of light signals instead of acoustic ones, guaranteeing a much greater axial resolution in the order of 10-20 m against the 150-200 m of the B-scan ultrasound.

OCT allows real-time, in situ visualization of tissue microstructures.

For this it can be exploited: in cases where the excisional biopsy is dangerous or impossible, such as for the eye, coronary arteries or nervous tissue, in oncological diagnostics it can be of help in addressing the location of the most significant site to perform a biopsy for histological examination, as a guide to microsurgical procedures, for the preoperative identification of peripheral extension edges of skin neoplasms.

Optical coherence tomography is a tool of great interest that allows the acquisition of further diagnostic information compared to dermoscopy, but it is more complex to use and has higher costs of the order of tens of thousands of Euros which make it very little to use. accessible for general use, but limited to a few specialized structures.

The use of confocal microscopy and some types of spectroscope for ex vivo and in vivo examinations are also limited.

The confocal microscope allows a very accurate analysis of skin lesions comparable to that obtainable on histological sections with optical microscopy but has as its limit the possibility of analyzing a very small area (about 1 mm²) on lesions that can be even greater than 1 cm² makes the examination extremely slow if extended to the entire skin mole. On the other hand, if the analysis were limited to a part of the new skin formation, there could be a risk of false negative diagnoses in the case of melanocytic lesions.

The cost of a few tens of thousands of Euros for the instrument makes it difficult at the moment to use this instrument outside highly specialized dermatological structures.

The following table shows a synthetic analysis between the competing devices and the proposed dermospectroscope tool:

Dissemination Tool Diagnostic Accuracy Pros and Cons of the Analysis

Dermatoscope The most widely used in Instrument than Economical, but the scope still requires hospital only the experience of an automatic analysis. outpatient. specialist for

the analysis.

Optical Coherence Not widely used, able to provide help for Tomography limited to a few precise details, the identification of structures of the microstructures of the specialist area. tissue. concerned on which to intervene. Complex and expensive

Microscope Present in Allows an analysis Accurate Confocal analysis of structures accurate but limited to dermatological skin lesions. a very highly restricted area. Very specialist. costly.

Dermospectroscope Can be Used for Instrument used in both compact and non-ambulatory settings. An accurate analysis requires a dermatological expert in the entire area of expertise and medical studies concerned by the specification for generics. alteration perform a pathological in screening. Competitive automatic price, even if not cheap.

The purpose of the invention is to create an electro-optical device for

dermatological application that overcomes or reduces the problems of the technique

Note.

SUMMARY OF THE INVENTION

The invention is based on the correlation of different analysis systems of the

Patient's skin that allow the analysis of the optical properties both in the

frequency band of the visible, both in the infrared and ne

they also perform spectral analysis.

The instrument integrates some optical and electro-optical devices (lens, LEDs, filters, spectrometer, cameras) which, once assembled, constitute sensors designed to acquire information on the optical characteristics of the area to be analyzed. From the examination of these characteristics, the diagnostic elements can be deduced to establish the type of tissue and any pathological alteration.

The information to be obtained is of different types and is to be acquired in different lighting or excitation conditions: color and infrared images, with white and monochromatic light illumination at different wavelengths, analysis of the reflection spectrum, analysis of the fluorescence spectrum by excitation at different wavelengths. For this purpose the sensors are turned towards a circular opening of the instrument, arranged in such a way that, once placed in contact with the area to be analyzed, it allows the correct framing and allows the analysis without having to align or focus the various sensors.

The instrument will be compact so that it is portable and will host "on board" all the functions of image acquisition, software analysis of the images with automatic diagnostic support and archiving of results and images.

The system includes:

- a lighting system according to different spectral ranges, possibly with polarized light;

- a shooting system consisting of an objective corrected for the visible and near infrared spectral band, one or more cameras, optical image separation components and possibly an interchangeable and / or sterilizable closing protection;

- an electromagnetic spectrum analyzer with diffraction grating, prism or other type;

- a mechanical support casing;

- an electronic system management subsystem;

- memory, wireless communication systems and firmware;

- software for comparison and spectral correlation of images.

More precisely, in a first aspect, the present invention describes an electro-optical device for dermatological application comprising: a window for viewing a skin area;

lighting means incident on the skin area through the window, in which the skin area is configured to generate optical information in response to lighting;

first optical sensor means configured to receive optical information; a processing unit configured for:

• receive in input the optical information received from the first optical sensor means;

• carry out an analysis of asymmetry, edges and size of the optical information, thereby determining data representative of a possible pathological alteration in the skin area;

second optical sensor means configured for:

• perform a color spectral analysis of the optical information, based on the data representative of a possible pathological alteration in the skin area, thereby causing a chromatic breakdown of a portion of the skin area;

• transmit the chromatic breakdown to the processing unit; in which the processing unit is configured to calculate at least one probability of pathological alteration as a function of the chromatic breakdown.

Preferably, the second optical sensor means carry out the spectral color analysis of the optical information when the representative data are representative of a presence of a pathological alteration in the skin area.

Preferably, the skin area is adapted to reflect the illumination received by the illumination means, thus generating the optical information. Preferably, the first optical sensor means comprise one or more of: - a first camera configured to detect the optical information in the spectrum of visible radiation;

- a second camera configured to detect optical information in the spectrum of infrared radiation.

Preferably, the second optical sensor means comprise at least one spectrometer configured to spectrally analyze the portion of the skin region.

Preferably, in the first optical sensor means, the optical information comprises an image of the skin area.

Preferably, in the second optical sensor means, the portion is a small area of the skin region.

Preferably, the small area of the skin area is located in the center of the image of the skin area.

Preferably, a small area of skin has a diameter of between 0.3 and 0.7 mm.

Preferably, the spectrometer comprises a spatial filter configured to delimit the portion on which the spectral analysis is carried out. Preferably, the spectrometer comprises:

- a diffraction grating, downstream of the space filter, configured to receive a light radiation coming from the space filter and to spectrally separate the light radiation by diffraction;

- a linear CCD configured to display spectrally separated and focused radiation.

Preferably, the electro-optical device comprises an optical system, interposed between the skin area and the optical sensor means, configured to form the image of the skin area illuminated by the lighting means.

Preferably, the lighting means comprise one or more of:

- at least one LED light source;

- a laser diode light source;

- a white light source.

Preferably, the skin area is adapted to generate an emission by fluorescence, in response to an illumination with visible or ultraviolet radiation received by the lighting means, thus generating the optical information.

Preferably,

- the lighting means are configured to illuminate the portion of the skin area;

- the skin area is configured to generate optical information in response to lighting;

- the second optical sensor means are configured to perform a fluorescence spectral analysis of the optical information, based on the data representative of a possible pathological alteration in the skin area, thereby determining a fluorescence spectrum.

Preferably, the second optical sensor means perform the fluorescence spectral analysis of the optical information when the representative data are representative of a presence of a pathological alteration in the skin area.

Preferably, the processing unit is configured to analyze the fluorescence spectrum and, based on the frequency analysis, determine a type of pathological alteration.

Preferably, the processing unit is configured to calculate at least one type of pathological alteration as a function of the fluorescence spectrum. Preferably,

- the skin area is capable of generating a Raman fluorescence emission characteristic of the tissue to be examined, in response to an illumination with a predefined wavelength received by said illumination means, thus generating the optical information.

Preferably,

- the lighting means are configured to illuminate the portion of the skin area;

- the skin area is configured to generate optical information in response to lighting;

- the second optical sensor means are configured to perform a Raman fluorescence spectral analysis of the optical information, according to the data representative of a possible pathological alteration in the skin area, thereby determining a Raman fluorescence spectrum.

Preferably, the second optical sensor means carry out the Raman fluorescence spectral analysis of the optical information when the representative data are representative of a presence of a pathological alteration in the skin area.

Preferably, the processing unit is configured to analyze the fluorescence spectrum and, based on the frequency analysis, select the Raman frequency characteristic of the tissue to determine a type of pathological alteration.

Preferably, the processing unit is configured to calculate at least one type of pathological alteration as a function of the fluorescence spectrum. Preferably, the electro-optical device comprises beam splitting means configured to divide the light radiation corresponding to the image formed on the optical system.

Preferably, said beam splitting means comprise one or more of:

- a first beam splitter interposed between the optical system and the spatial filter; - a second beam splitter interposed between the first beam splitter and the first optical sensor means.

Preferably, the first beam splitter comprises a semi-reflective mirror.

Preferably, the second beam splitter comprises a dichroic semi-reflective mirror.

Preferably, the optical sensor means, the lighting means and the processing unit have dimensions of the order of cubic centimeters. In a second aspect, the invention describes a housing configured and sized to contain the electro-optical device described with reference to the first aspect of the invention.

Preferably, the housing is characterized by having a footprint of the order of cubic centimeters.

The invention, in terms of its characteristics related to their respective technical effects / functionality, refers to one or more of the following:

- a tool for the vision and analysis of an epidermal area that correlates its optical properties to different wavelengths. The feature of the system is that it is portable and automated. It provides the operator with both the image of the examined area and information regarding the extent and nature of a possible area, a pathological alteration and its extension present in the examined area. The correlation is obtained by analyzing the images and spectra obtained under different lighting and acquisition conditions;

- a portable instrument that implements the ABCD analysis methodology by analyzing images acquired with white light illumination; - a portable instrument that performs the analysis of images acquired with near infrared illumination;

- a portable instrument that carries out the analysis of the reflection spectrum of the area to be examined illuminated with visible light;

- a portable instrument that carries out the analysis of the reflection spectrum of the area to be examined illuminated with infrared radiation;

- portable instrument that carries out the analysis of the fluorescence spectrum of the area to be examined illuminated with visible or ultraviolet radiation; - a portable instrument that carries out the analysis of the Raman emission characteristic of the tissue to be examined with illumination at a given wavelength;

- a portable instrument that carries out the analysis of the fluorescence spectrum of the area to be examined illuminated with visible or ultraviolet radiation and covered with chromophores, fluorophores or metal nanoparticles;

- a portable instrument that carries out two or more analysis techniques among those described.

The dermospectroscope can be used to create a new line of research in the study of the pathophysiology of retinal tissues and in the early diagnosis of central and peripheral retinopathies using, appropriately calibrated, the analysis systems implemented for the analysis of skin pathologies. In the case of the dermospectroscope for the use of retinal tissue analysis, the focal length of the system will be varied in order to focus on the area corresponding to the patient's retina.

The dermatoscope will be able to transfer data in the "cloud" using a wireless communication system. It will therefore be possible to remotely archive data, remote diagnosis and create meaningful databases by collecting the data provided by a statistically significant number of dermatoscopes. The cited technical effects and other technical effects of the present invention will result in more detail from the description, given below, of an example of embodiment given by way of non-limiting example with reference to the attached drawings.

BRIEF DESCRIPTION OF THE FIGURES

The description is provided below with reference to the accompanying figures, also having a purely illustrative and therefore non-limiting purpose, in which figure 1 schematically shows the components of the device, according to the invention.

DETAILED DESCRIPTION

The present invention relates to an electro-optical device for dermatological application as defined in the attached claims. The invention is now described with reference to a currently preferred embodiment thereof, reported for illustrative and non-limiting purposes in the attached figure 1.

The optical system 11 forms the image of an area of the skin 12 illuminated by LED light 13 (or by a laser diode or white light source).

The image is acquired by three different sensors: a sensitive camera in the visible radiation spectrum 14, a sensitive camera in the infrared radiation spectral area 15 and a spectrometer 16.

The division of the light radiation that generates the image is obtained by means of the semi-reflective mirror 17 and the dichroic semi-reflective mirror 18.

A part of the light radiation corresponding to the acquired image is directed to the sensitive camera in the visible radiation spectrum 14.

The camera 14 will acquire the image of the area of the skin 12 corresponding to the frequencies of the visible radiation.

A part of the light radiation corresponding to the acquired image is directed to the sensitive camera 15 in the infrared radiation spectrum.

The camera 15 will acquire the image of the skin area 12 corresponding to the near infrared frequencies.

A part of the light radiation corresponding to the acquired image is directed towards the spatial filter 21, which is part of the spectrometer 16. The light radiation that has passed through the spatial filter 21 affects a diffraction grating 22 and is spectrally separated by diffraction and then focused on the linear CCD 23.

The task of the spatial filter 21 is to delimit the area of the skin on which the spectral analysis is carried out.

At this point in input to the software analysis system we will have different ways of acquiring distinct information:

- visible color image of the area to be examined;

- near infrared image of the area to be examined;

- image of the area to be examined illuminated with monochromatic light at different wavelengths,

- spectrum of reflected frequency components,

- fluorescence of the area to be examined illuminated with monochromatic light at different wavelengths,

- Raman emission characteristic of the fabric.

Advantageously, in correspondence with each of these acquisitions, a series of additional information can be obtained by modifying the wavelengths of illumination both in the visible, in the ultraviolet spectral band, and in the near infrared.

The instrument integrates some optical and electro-optical devices (lens, LEDs, filters, spectrometer, cameras) which, once assembled, constitute sensors designed to acquire information on the optical characteristics of the area to be analyzed. From the examination of these characteristics, the diagnostic elements can be deduced to establish the type of tissue and any pathological alteration.

The information to be obtained is of different types and is to be acquired in different lighting or excitation conditions: color and infrared images, with white and monochromatic light illumination at different wavelengths, analysis of the reflection spectrum, analysis of the fluorescence spectrum by excitation at different wavelengths. For this purpose the sensors are turned towards a circular opening of the instrument, arranged in such a way that, once placed in contact with the area to be analyzed, it allows the correct framing and allows the analysis without having to align or focus the various sensors.

Operationally, a doctor places the instrument with the opening in contact with the area to be analyzed and then turns it on. Inside, some white LEDs light up and illuminate the area to be analyzed in order to allow a color camera connected to an external monitor to show the image. If the doctor believes that the area of interest is not correctly framed, move the instrument until the defect to be analyzed is brought into the central area of the image. To do this, he is helped by a synthetic lattice that the instrument software generates and superimposes on the image shown. When the positioning is satisfactory, the doctor gives consent at the beginning of the analysis, namely the following acquisitions that occur in rapid sequence.

- Acquisition and registration of the color image with the area to be examined illuminated with light provided by white LEDs. This allows the analysis of the pathological alteration to be carried out automatically via software by means of filtering and algorithms resident in the instrument. For example, it allows the well-known and widespread diagnosis method called ABCD to be made automatic (an operation similar to that carried out by the most sophisticated videodermatoscopes) by illuminating the image in the visible area of the area to be examined, the image is conveyed towards the color camera that acquires, the image is then analyzed via software, the results of the analysis, the diagnostic support data and the image itself are recorded in the instrument's memory. The data and image are then displayed on a display for use by the examiner and also stored for subsequent applications. Basically, this analysis makes the diagnosis made so far by an expert dermatologist automatic and objective.

- Acquisition and recording of the image with the area to be examined illuminated in specific wavelengths of the near infrared. Since the cameras are also sensitive to radiation outside the visible spectrum, it is also possible to acquire an image in the near infrared. The skin area to be examined can be illuminated at wavelengths in the near infrared spectral band, obtaining an image that is not visible to the naked eye but which gives further information that allows to complete the previous analysis but adding new elements that increase specificity. and the sensitivity of the ABCD diagnosis. This type of analysis follows the procedure similar to that described above for the image acquired with illumination in the visible light spectrum but involves the use of near infrared emission LED sources as illuminators. Being carried out in a spectral area invisible to the eye, this analysis is a factor impossible to obtain by direct observation.

- Some pathologies have a different profile when illuminated in visible light or in infrared light. The image obtained with visible illumination is superficial (the one observed also by the dermatologist), the one with infrared illumination is under the skin. The two images may be different, revealing different dimensions of the supracute and subcutaneous pathological alteration. This data provided by the tool is

extremely important for the surgeon in case of excision of the pathological area, allowing the targeted excision of all and only the area affected by the pathological alteration limiting the excision damage for the patient.

- Analysis of the reflection spectrum of the central area of the image by means of white light illumination. The image of a small part of the central framed area, about half a millimeter in size, is transferred to a spectrometer which returns the reflection spectrum for the identification of the pathological alteration through its spectral signature, i.e. through the presence or absence of specific absorption zones in the visible radiation spectrum. The visible light reflection spectrum allows to obtain much more detailed color information of the examined area than that which can be obtained with direct observation or registration of the color image. In particular, from the reflection spectrum it is possible to note the presence or absence of specific spectral zones of light absorption which reveal the nature of the examined zone. For example, the reflection spectrum of a pathological area may reveal almost zero reflection at 400nm while at 700nm the area becomes partially reflective. From the comparison of the data of the reflection response at different wavelengths, we obtain the spectroscopic data that allow to classify a specific pathological alteration.

- Analysis of the reflection spectrum of the central area of the image by means of near infrared illumination. Similarly to the previous point, the same analysis can be carried out using a near infrared light source and analyzing the reflected image of the area to be analyzed with a spectrograph. As in the previous point, the reflection coefficients of the examined area will have different values whose correlation will allow to identify the type of pathological alteration.

- Analysis of the fluorescence spectrum of the central area of the image by ultraviolet lighting. A small part of the central framed area, about half a millimeter in size, is illuminated with ultraviolet light. Its image is transferred to a spectrometer which returns the fluorescence spectrum, in a similar way to what was done in the previous points. In this case, however, instead of observing the reflection at the individual wavelengths of illumination, we observe the radiation re-emitted from the surface at longer wavelengths. The re-emitted radiation spectrum, fluorescence spectrum, is characteristic of the type of tissue and therefore provides information on the nature of the pathological alteration.

- Raman fluorescence analysis. The Raman fluorescence wavelength is characteristic of the analyzed tissue. The wavelengths of healthy tissue differs from that of pathological tissue. The area analyzed by the instrument will be illuminated with a characteristic wavelength. The emission spectrum of the analyzed area will show both the Raman fluorescence wavelength and the incident wavelength reflected by the tissue. The reflected component can be shielded by a frequency filtering system. The spectrograph will allow to distinguish the reflected component from the Raman fluorescence component. The Raman fluorescence component provided by the spectrograph will be characteristic of a healthy tissue or of a pathological tissue and will therefore allow to determine the nature of the tissue examined.

- By correlating all the information acquired from the images, from the reflection spectra in the visible and infrared, from the fluorescence spectrum and from the Raman emission, we obtain the data that allow us to characterize the size and type of the tissue examined in an innovative way and therefore the tool is able to provide a diagnostic probability with high specificity.

- Following the acquisition of spectral data in the different regions of space, through appropriate mathematical-physical re-elaboration, it will be possible to provide a three-dimensional prospect of the new skin formation, in the different regions of the spectrum. Through these data and state-of-the-art numerical integration algorithms, it will be possible to provide data such as volume and irregularities of the new skin formation, with a level of accuracy.

- The technique will be further refined and specified thanks to the use of molecules (chromophores or fluorophores) which - thanks to their absorption / emission properties with one or two solvent-sensitive photons - will allow to better enhance the definition of new skin formations. These systems will be conveyed through means such as ointments, creams, eye drops, etc. so that they come into contact with the new skin formations interact specifically. In the case of nonlinear optics properties, the image relating to the new skin formation will be highlighted with greater clarity and definition, thanks to the abatement of scattering phenomena. It will also be possible to use functionalized metal nanoparticles, in order to exploit the shift of the plasmon resonance frequency in the IR region.

The various acquisitions are commanded in sequence and can have a total duration of the order of one second. After a few moments of processing, the instrument emits the diagnostic indication. The analyzes are carried out on a circular area, corresponding to the opening of the instrument, while the image on the camera is rectangular. The area of the image not used for analysis can be advantageously used as a reference for periodic calibrations, taking care to apply a paint with known optical characteristics internally around the opening.

IMPROVEMENT OF KNOWN TECHNIQUE

An expert system will be provided that can semi-automatically analyze the acquired images and then provide useful information for diagnosing the pathological alteration and the extent of the area actually affected.

A use of the system that we propose allows the recording of the diagnostic support data generated by the system and of the images acquired, also making it possible to follow-up the evolution of the patient's problem over time.

In general, the Applicant has perceived that the dermospectroscope will constitute a valid support for medical personnel and will allow an improvement in the field of prevention and early recognition of diseases.

In particular, the Applicant has therefore perceived that the device in accordance with the following invention will provide a series of diagnostic information not currently provided by the instruments in use:

• Using the system object of the present invention, and in particular only point 1 relating to the analysis of the color image of the area to be examined, the known ABCD analysis can be carried out, unlike what currently happens, automatically and without the need for evaluation by an experienced dermatologist. This type of analysis also removes the uncertainty linked to the subjectivity of the judgment of the dermatologist equipped only with the dermatoscope. The acquired information (asymmetry, edges, color and dimensions) will be quantitatively evaluated by means of a specially developed software.

The other acquisitions will provide additional diagnostic information:

• The real extension of the pathological area through the correlation between the image of the visible area and that in the near infrared which allows the examination of the subcutaneous area (which may vary in thickness from one skin district to another).

• The well-known (for patent maker, see: "MIDST Project") comparison between images of the affected area illuminated in monochromatic light at different specific wavelengths, carried out using software analysis algorithms, allows, from the different response of the affected area, to determine the type of pathological alteration found.

• The spectral analysis of the area to be examined illuminated with a broad spectrum source (visible and infrared) allows a much more accurate definition of the color than that which a human eye can perform as the resolution of the instrument is much greater: while the eye recognizes only three chromatic components, a spectrometer decomposes the light into a number of chromatic components normally of the order of hundreds, allowing a much more accurate color recognition. Furthermore, the analysis can be extended to the near infrared, considerably expanding the information useful for the realization of the diagnostic indication that the instrument provides.

• The well-known analysis of the fluorescence spectrum of the area illuminated with a monochromatic source makes it possible to recognize the type of tissue and any pathological alteration as their spectral response has a recognizable and univocal trend.

The improvement with respect to the known art given by the correlation of the various types of analysis described above is:

• Automatic diagnostic indications based on the ABCD technique.

• Improved accuracy of the diagnostic indication as it is made not only based on the classical method of ABCD analysis but also on the different methods of analysis described above.

• The correlation between the images of the affected area illuminated in the visible and in the near infrared allows to determine the real extension of the pathological area both at the surface and at the subcutaneous level.

• Objective diagnostic indication not linked to the dermatologist's subjectivity of judgment, repeatable and independent of the different lighting conditions.

• Possibility of using the instrument and therefore of receiving diagnostic indications from non-specialist medical personnel.

It will also allow an innovative use of the instrument in the medical field: • The system gives an automatic response of the probability of pathological alteration therefore the presence of a dermatologist specialist is not necessary for the analysis of skin diseases and therefore also a general practitioner can use it .

• Use of a tool with diagnostic indications made automatically and therefore elimination of the uncertainty linked to subjectivity introduced by direct observation.

• The instrument's own lighting allows to reduce the diagnosis errors due to the different types of lighting and therefore to the different chromatic dominants that can alter the dermatologist's evaluation of the color of the area concerned.

• Possibility of evaluating the evolution of the pathological alteration over time by creating a history for each patient.

• The instrument allows analysis of significant portions of the new skin formation (typically 1cm2) to allow faster operating times than other procedures, such as confocal microscopy, which allows a very detailed analysis but in very limited fields, which must be recomposed and assembled in order to obtain an overall image that allows to reach a diagnostic conclusion.

• The use of this system will allow to extend the number of people monitored by allowing mass screening of the population which is now not possible for the limited number of dermatological specialists.

• Ability to carry out diagnostic imaging outside the hospital facilities in order to reduce the ever-increasing pressure on this type of structures and favor users with less travel, less discomfort and less personal costs.

• It will allow the classification of the person's phototype.

• Possibility of creating a database of a statistically significant population in a simple and low-cost way.

• Possibility of using integrated systems of dermospectroscopes connected via an integrated software platform. This platform will allow medical personnel to be able to consult a structured database of clinical examinations associated with diagnoses, will then allow them to easily and in real time compare the opinions of different diagnosticians on a doubtful case, make the medical guidelines for pathology easily accessible and updateable with the aim of creating increasingly effective and internationally accepted ones, it will also make it possible for the Diagnosticist to compare the modalities of intervention for pathology adopted in the various centers of excellence and will allow the diagnostic news to be communicated between the various Medical Centers and the new possibilities of intervention for types of pathology.

• Possibility of remote diagnosis.

• Possibility of data storage in "cloud".

Furthermore, the innovation of the instrument with respect to the prior art will concern: • A single device that provides automated diagnostic support to the dermatologist.

• Portability of the instrument for reduced dimensions compared to more complex machines such as OCT and Confocal Microscope.

• Ease of use compared to the tools mentioned above.

• The extremely low expected cost compared to the tools mentioned above will allow a large-scale use, both in hospitals, both among specialist dermatologists, and by general practitioners.

• Technological innovation of the tool that provides diagnostic information thanks to the "on board" processing of the acquired data.

Furthermore, the use of the dermospectroscope is part of the guidelines of the National and World Healthcare allowing:

• Prevention of pathologies by means of equipment for the early diagnosis of pathologies.

• Targeted screening of the population at risk to reduce actual and social costs, as well as to improve living conditions. • Savings on healthcare costs due to the possibility of making early diagnoses at low cost because they can be achieved through a simple automatic processing of images in a statistically significant number, this will allow an improvement in the life of the Patients for the early detection of the disease and increase the chances of recovery .

• Possibility of providing public and private health structures with the possibility of clinical analyzes outside the hospital structures in order to reduce the ever-increasing pressure on this type of structures and to be able to carry out mass screening of the portion of the population at risk for the early diagnosis of pathologies, to reduce actual and social costs, as well as to improve living conditions without increasing the diagnostic workload in hospitals.

• Given the extremely small number of dermatological specialists compared to the population, the dermospectroscope will be able to extend the diagnostic possibility of first diagnosis also to general practitioners.

• Great savings on healthcare costs due to the possibility of making early diagnoses at low cost because they can be achieved through a simple automatic processing of images in a statistically significant number, this will allow an improvement in the life of patients for the early detection of the disease and will increase the chances of healing.

Furthermore, a further advantage with respect to the prior art is the possibility of extending the possibilities of diagnosing skin pathologies also to structures currently not designed for the purpose as its use will be extended to:

• Public hospitals, nursing homes affiliated with the national health system, private diagnosis and treatment facilities.

• Public, affiliated and private multi-specialist outpatient clinics.

• General practitioners.

• Territorial health structures, which carry out screening of portions of the population.

• Companies that provide training and refresher services to healthcare personnel

Claims (10)

CLAIMS 1. Electro-optical device for dermatological application comprising: - a window (10) for viewing a skin area (12) - lighting means (13) incident on said skin area (12) through said window (10), in which said skin area (12) is configured to generate optical information (110) in response to said illumination; - first optical sensor means (14.15) configured to receive optical information (110); - a processing unit (30) configured for: • receive in input the optical information (110) received from the first optical sensor means (14,15); • carry out an analysis of asymmetry, edges and size of said optical information (110), thereby determining data (D_PAT) representative of a possible pathological alteration in said area of the skin (12); - second optical sensor means (16) configured for: • perform a color spectral analysis of said optical information (110), as a function of said data (D_PAT) representative of a possible pathological alteration in said area of the skin (12), thereby determining a chromatic breakdown (S_crom) of a portion (121) of said area of the skin (12); • transmitting said chromatic decomposition (S_crom) to said processing unit (30); wherein said processing unit (30) is configured to calculate at least one probability of pathological alteration (P_PAT) as a function of said chromatic decomposition (S_crom). 2. Electro-optical device according to claim 1 wherein said first optical sensor means (14,15) comprise one or more of: - a first camera (14) configured to detect optical information (110) in the spectrum of visible radiation; - a second camera (15) configured to detect optical information (110) in the spectrum of infrared radiation. and said second optical sensor means (16) comprise at least - a spectrometer (16) configured to spectrally analyze said portion (121) of said area of the skin (12). 3. Electro-optical device according to any one of the preceding claims, wherein said illumination means (13) comprise one or more of: - at least one LED light source; - a laser diode light source; - a white light source. 4. Electro-optical device according to any one of the preceding claims, in which said area of the skin (12) is adapted to generate an emission by fluorescence, in response to an illumination with visible or ultraviolet radiation received by said illumination means (13) , thereby generating said optical information (110). 5. Electro-optical device according to claim 4 wherein: - said lighting means (13) are configured to illuminate said portion (121) of said area of the skin (12); - said area of the skin (12) is configured to generate optical information (110) in response to said illumination; - said second optical sensor means (16) are configured to perform a fluorescence spectral analysis of said optical information (110), as a function of said data (D_PAT) representative of a possible pathological alteration in said area of the skin (12), thereby determining a fluorescence spectrum (Sp_f) 6. Electro-optical device according to any one of the preceding claims, in which said area of the skin (12) is adapted to generate a Raman fluorescence emission characteristic of the tissue to be examined, in response to an illumination with a predefined wavelength received from said illumination means (13), thereby generating said optical information (110). 7. Electro-optical device according to claim 6 wherein: - said lighting means (13) are configured to illuminate said portion (121) of said area of the skin (12); - said area of the skin (12) is configured to generate optical information (110) in response to said illumination; - said second optical sensor means (16) are configured to perform a Raman fluorescence spectral analysis of said optical information (110), as a function of said data (D_PAT) representative of a possible pathological alteration in said area of the skin (12) , thereby determining a Raman fluorescence spectrum (Sp_f). Electro-optical device according to any one of claims 4 to 7 wherein said processing unit (30) is configured to calculate at least one type of pathological alteration (T_PAT) as a function of said fluorescence spectrum (Sp_f). 9. Electro-optical device according to any one of the preceding claims, in which said optical sensor means (14, 15, 16), said illumination means (13) and said processing unit (30) have overall dimensions of the order of cubic centimeters. 10. Housing configured and sized to contain said electro-optical device according to claim 9.