Non-invasive diagnostic system for the evaluation of scars and related method

Description

Description of the Industrial Invention entitled: “NON-INVASIVE DIAGNOSTIC SYSTEM FOR THE EVALUATION OF SCARS AND RELATED METHOD” in the name of: Di Santo Claudia, of Italian nationality Designated Inventor: Di Santo Claudia Filed under no. DESCRIPTION The present invention relates to a diagnostic system 10 non-invasive for the evaluation of scars, and the related method. In particular, the invention relates to a system and a method non-invasive in vivo for instrumental diagnosis of tissue cicatricial through quantitative and qualitative analysis of the 15 optical properties, with data and image processing through artificial intelligence algorithms More specifically, the invention relates to a non- invasive in vivo for the diagnosis of cicatricial alterations, based on the evaluation of physical properties, in particular 20 optical ones, of the fabric. The main objective is to identify all the components characterizing scar tissue, in order to obtain an instrumental diagnosis based on parameters as much as possible as objective and reproducible as possible. This method finds application not only in the medical field- clinical, but also in research and technological innovation. It 5 involves numerous scientific disciplines, including bioengineering tissue and electromedical, physics, chemistry, biology, computer engineering, artificial intelligence and computer science materials. In the medical field, the proposed method not only allows a 10 accurate diagnosis of scars, but also allows you to monitor their evolution and the effectiveness of the treatments applied. Furthermore, it can significantly contribute to broadening knowledge on wound healing processes, on pathologies related to fibrotic alterations and various dermatological problems. 15 The invention relates to a system and a method for the diagnosis advanced scar treatment, applicable in the fields of dermatology, of plastic surgery, regenerative medicine and in all clinical contexts where it is necessary to monitor the evolution of scars. 20 In the field of scar diagnostics, there are currently several technologies and methods are used to evaluate them and treat them, including hypertrophic and keloid ones. These approaches range from advanced imaging techniques to clinical evaluations standardized. As regards clinical assessments and scales of measurement, scars are commonly assessed using 5 standardized clinical scales, such as the Vancouver Scar Scale (VSS), which considers parameters such as vascularization, pigmentation, flexibility and height of the scar. Although widely used, these methods suffer from subjectivity, since they are based on visual observation and the clinician's experience. 10 As regards optical imaging techniques, they are focus mainly on the non-invasive assessment of properties of scar tissue, such as structure, vascularization and optical properties. However, each of these techniques, taken individually, provides limited and not always information 15 sufficient to fully characterize the structure three-dimensional of scars or their physical properties, in especially the optical ones. Among the main technologies available are: 1. Optical Coherence Tomography (OCT): OCT is widely 20 used for the evaluation of scars thanks to its ability to provide high-resolution images of structures superficial skin. However, its limited ability to penetrating deep makes it difficult to evaluate the deeper scars. 2. High Frequency Ultrasound: This technique offers good spatial resolution and allows the visualization of larger structures 5 deeper than OCT. It is particularly useful for measuring the thickness of the dermis and identify structural abnormalities in the tissue cicatricial, but the quality of the images depends strongly from the operator's skill. 3. Photoacoustics (PAI): Photoacoustics is an emerging technique 10 which combines the advantages of optical and acoustic imaging. It allows to obtain detailed information on the vascularization and structure of scar tissue, penetrating deeper compared to pure optical imaging. However, its application large-scale clinical use is still limited. 15 4. Fibroscan: originally developed for the evaluation of liver fibrosis, Fibroscan is sometimes used to evaluate the hardness of scar tissue. This technology is less common in dermatological practice and more suitable for softer tissues thick and internal. 20 5. Confocal Dermatoscopy: This technology provides images high resolution of surface cellular structures, similar to those obtainable with a biopsy but in a non-invasive way. However, its ability to analyze deeper structures is limited. Laser-based treatments and diagnostics, such as the pulsed dye laser (PDL) and fractional laser, are widely used for both treatment and evaluation of Scars. Despite their effectiveness in reducing their visibility 5 of the scars, these techniques have limitations in their ability to diagnose complex cicatricial changes and evaluate the individual response to treatments. Recently, computational models have been developed and artificial intelligence (AI) algorithms to analyze images 10 of the scars, with the aim of improving accuracy diagnosis and reduce subjectivity. Although promising, these approaches are still in the experimental stage and their effectiveness depends from the quality and quantity of the data used for training the algorithms. 15 The limitations of existing solutions and technologies are: - subjectivity: many current methods, such as the scales of clinical evaluation, are highly dependent on subjectivity of the operator, leading to variability in results; - limited penetration: optical technologies, such as OCT and 20 confocal dermatoscopy, are limited in their ability to penetrate into depth in the tissues, making a complete assessment difficult more extensive scars; - operator-dependent variability: technologies such as ultrasound require significant technical expertise, which can lead to variability in results based on operator experience; - incomplete characterization of tissues: the technologies 5 existing ones often fail to fully characterize the physical properties of scar tissue, which are essential for a precise diagnosis; - limitations in imaging: available imaging techniques may not provide a sufficiently detailed view or 10 three-dimensional scars, limiting the ability to understand fully understand the structure of the fabric and its evolution over time; - limited clinical implementation: although technologies such as photoacoustics show great promise, their clinical adoption is still limited and further studies are needed to evaluate it 15 large-scale effectiveness; - variable effectiveness of treatments: despite progress in laser treatments and other therapies, the response to therapies can vary significantly between patients, and not all types of scars respond satisfactorily. 20 These limitations highlight the need for further developments technologies to improve accuracy and objectivity in diagnosis of scars, especially with regards to the evaluation of the physical and structural properties of fabrics in depth. The proposed invention fits into this context, aiming to overcome many of the existing limitations through a comprehensive approach 5 non-invasive based on the evaluation of physical properties and tissue optics, supported by advanced image analysis and data through artificial intelligence algorithms. The invention solves the following problems: scars are the result of complex tissue repair processes. However, 10 in some cases they can evolve negatively, giving rise to hypertrophic scars or keloids. Currently, there are no methods standardized diagnostics that allow for precise predictions an unfavorable evolution, making early intervention difficult. To date, there is no integrated diagnostic system capable of 15 to combine advanced technologies for a comprehensive assessment of the scars, nor one designed to offer such a detailed analysis and non-invasive. The proposed invention represents a unique system that integrates several existing technologies, creating an innovative approach for diagnosis. The integration of various technologies allows for 20 obtain a multidimensional assessment of scars, allowing for the precise identification of tissue components and cell phones. This system is designed to distinguish scars with potential unfavorable evolution from those that do not present risks, offering fundamental support in clinical management. A crucial aspect of the invention is the ability to identify myofibroblasts, key cells in the processes 5 repairers, including through the detection of alpha-SMA proteins (alpha-smooth muscle actin) and fibronectin EDA. Alpha-SMA is a marker of scar tissue contraction, while the Fibronectin EDA is associated with matrix deposition extracellular and modulation of the fibrotic response. 10 The ability to detect these markers allows us to evaluate with to accurately determine the state of the scar and predict its evolution, providing essential diagnostic indications for targeted interventions. The diagnostic system is non-invasive, eliminating the need of interventions that may damage tissues or cause discomfort and / or 15 harm to the patient. Furthermore, it does not require the use of biomarkers. invasive, operating entirely in vivo. This approach guarantees an accurate and safe assessment, significantly improving the clinical management. Pathological scars, such as hypertrophic scars and keloids, 20 entail significant economic and social-health costs, in addition to serious psychological and physical consequences for patients. The proposed invention has the potential to reduce these costs significantly. Direct costs associated with scar management include medical expenses related to treatments, which may include laser therapies, corticosteroid injections, surgeries surgical and drug treatments. According to estimates, the treatment of 5 scars represents a significant expense for health systems, with costs that can reach billions of dollars a year, especially when considering the repeated therapies required for manage problematic scars and their complications. These costs may further increase when considering treatments 10 for scars resistant to standard therapies, which require more advanced and expensive interventions. Indirect costs include lost productivity due to reduced working capacity and absenteeism caused by treatments or disabilities associated with scarring. 15 Scars, especially those that limit mobility or cause chronic pain, can significantly reduce productivity, generating a negative economic impact for both individuals and society as a whole. Furthermore, the psycho-physical discomfort and the functional difficulties can prolong recovery times and 20 increase the need for ongoing care. Visible scars can profoundly affect your quality of life, causing self-esteem problems, anxiety, depression and social isolation. The psychological impact is particularly relevant in populations that have suffered trauma or surgical interventions, where the scars not only remind of the event traumatic, but can also hinder social reintegration and work. These problems may require further interventions psychological and psychiatric, further increasing costs for the 5 health systems. In addition to natural problems, scars can have relevant symptomatic implications such as chronic pain, itching and physical discomfort, significantly worsening the quality of life life. These symptoms can lead to further complications, such as 10 Sleep Disorders and Chronic Fatigue That May Require of additional medical care. The associated physical and psychological discomfort scars can reduce your ability to perform activities daily, increasing dependence on ongoing therapies. The proposed invention integrates advanced technologies such as OCT, 15 polarimetry, diachrony analysis, Raman spectroscopy and photoacoustic analysis, offering an innovative solution: this integrated diagnostic system allows for early identification scars with an unfavorable evolutionary potential, improving the accuracy of the diagnosis and personalising treatments. 20 ability to detect myofibroblasts by markers biomoleculars such as alpha-SMA and fibronectin EDA is crucial for predict the evolution of scars and intervene promptly. These markers are essential in evaluating the status of the scar and in predicting its evolution, allowing to reduce the need for costly and invasive subsequent interventions. Furthermore, the system's non-invasive, in vivo approach eliminates the need for external biomarkers or surgical interventions, reducing risks for the patient and improving the quality of diagnosis and 5 of the treatment. In summary, the invention not only improves diagnosis and scar treatment, but also has the potential to reduce significantly reduce associated costs and improve psychological well-being physical condition of patients. 10 The invention, as claimed in the respective claims independent, consists of a non-invasive diagnostic system designed for comprehensive component evaluation characterizing skin scars. This system combines different innovative technologies to analyze tissue properties, 15 cellular and molecular mechanisms of scars, with particular attention to the detection and monitoring of myofibroblasts, cells crucial in the healing process and in the formation of pathological scars such as hypertrophic scars and keloids. This The system integrates several advanced technologies: Coherence Tomography 20 Optical CT (OCT), which provides high-resolution images of the internal structure of scars; matrix polarimetry Muller, who measures the birefringence of the tissue to identify structural alterations; the analysis of diachrony, which allows the temporal monitoring of the evolution of scars, observing such as cellular and tissue components, in particular myo- fibroblasts, they change over time; Raman spectroscopy, which analyzes the chemical composition of scar tissue for identify biomarkers such as α-SMA and EDA fibronectin, 5 indicators of myofibroblast activation status; opto-acoustic technology, which measures the elasticity and density of scar tissue. This ability to monitor the scar over a period of time allows for the early detection of signs of a possible pathological evolution and to intervene promptly 10 with targeted treatments. The system works by collecting optical data and spectroscopically from scar tissue in vivo, using a combined interface that facilitates simultaneous acquisition from all integrated modules. This data is then processed by a central unit equipped with artificial intelligence algorithms, 15 that were trained on a large dataset of images and data clinical scars. The algorithms analyze and classify the scars based on the probability of an unfavorable evolution, providing physicians with clear and timely indications for interventions targeted. The system has the ability to identify early 20 scars at risk of unfavorable evolution, customization of treatments based on the results of the analysis, and monitoring continuous scar evolution, with a focus on the dynamics of myofibroblasts. This allows for a more clinical management effective and personalized, reducing the risk of complications and improving therapeutic outcomes. The invention system represents an innovation significant in the diagnosis of skin scars, providing a 5 non-invasive and complete evaluation of tissue characteristics, cellular and molecular mechanisms of scars. This system is designed to address the limitations of diagnostic technologies existing, offering a multidimensional and precise diagnosis through the integration of advanced technologies. 10 Optical and spectroscopic data are collected in vivo from scar tissue through a combined interface that integrates different technologies to ensure a complete evaluation. 1. Tissue Analysis of the Scar Technologies Used: 15 Optical Coherence Tomography (OCT): Allows you to obtain high resolution images of the internal structures of the scar, analyzing collagen fiber architecture and integrity of the different tissue components. Muller Matrix Polarimetry: Used to evaluate the 20 anisotropic optical properties of scar tissue, providing detailed information on the orientation of collagen fibers and on the presence of structural disorganizations that could indicate an unfavorable evolution. 2. Cellular Analysis of the Scar Technologies Used: Diachronic Analysis: This method consists in monitoring of the scar over time, using images and data collected at 5 regular intervals to evaluate the dynamics of myofibroblasts. The analysis of diachrony allows us to observe how the population of myo-fibroblasts evolves, providing indications on the risk of formation of pathological scars. Raman Spectroscopy: This non-invasive technique allows 10 molecular analysis of the cellular components of the scar, with particular attention to myofibroblasts. Through the Raman spectroscopy, it is possible to identify the presence of α-smooth muscle actin (α-SMA), a characteristic marker of myo- fibroblasts, without the need for additional stains or markers. 15 technique allows to detect variations in the concentration of α- SMA, providing information on the density and activity of myo- fibroblasts. 3. Molecular analysis of the scar Technologies Used: 20 MSOT (Multispectrum Optical Tomography): MSOT is used for visualize and quantify molecular biomarkers in tissue cicatricial, such as blood oxygenation and distribution of specific proteins. In relation to myofibroblasts, MSOT can monitor oxygenation levels and blood pressure gradients tissue, factors that influence the activity of myofibroblasts and the their contribution to pathological healing. This technology allows you to obtain three-dimensional images, providing a framework 5 detailed distribution and functional status of the cells inside the scar. The choice of the proposed technologies was carefully motivated on the basis of their unique capabilities to deliver detailed and non-invasive information on the characteristics 10 tissue, cellular and molecular mechanisms of scars. Here are the Rationale for each selected technology: OCT: is a high-resolution optical imaging technology that allows you to obtain detailed images of the internal structures of the tissues, similar to a non-invasive "optical biopsy." It is 15 particularly useful for scar analysis as it can reveal the organization of collagen fibers, the architecture tissue and the overall integrity of the scar. This ability It is essential to identify the structural features that may be indicative of an unfavorable evolution, such as the 20 formation of hypertrophic scars or keloids. Muller Matrix Polarimetry: allows to analyze the anisotropic properties of fabrics, such as the orientation of the fibers collagen and the structural heterogeneity of scar tissue. This technology is crucial to detect disorganizations in fibers that may be indicative of scar tissue problematic. The ability to assess the arrangement of the fibers of collagen provides key information about how the scar is healing 5 reshaping, which is essential to predict whether the scar will evolve unfavorably. Diachronic Analysis: It is based on temporal monitoring of scar characteristics through imaging and other data collection techniques. This approach allows us to follow 10 the evolution of the scar over time, observing changes dynamics in cellular and tissue components. It is particularly useful for monitoring myofibroblast activity over time and for detect any changes that may indicate a risk of unfavorable evolution. This ability to monitor the tissue 15 continuous and longitudinal scarring is essential for intervene promptly if signs of pathological scarring. Raman spectroscopy: it is a non-invasive technique that allows to obtain precise molecular information directly from the tissue, 20 without the need for markers or contrasts. It is particularly useful to identify and quantify specific molecules, such as α-actin smooth muscle (α-SMA), a distinctive marker of myofibroblasts. myofibroblasts are crucial in wound healing and their activity can significantly influence the outcome of the scar. Raman spectroscopy provides a non-invasive means to monitor the activity of myofibroblasts, allowing a early diagnosis of the risk of pathological scarring. Multispectrum Optical Tomography (MSOT): combines resolution 5 spatial ultrasound with optical sensitivity, allowing the three-dimensional visualization and quantification of specific biomarkers in scar tissue, such as oxygenation of the blood and the distribution of specific proteins. This is particularly relevant to understanding the microenvironment of the 10 scar, which can influence the activity of myofibroblasts and the healing process. MSOT provides crucial information on the functional state of the scar, which, combined with the data tissue and cellular, allow a complete evaluation of the risk of unfavorable evolution. 15 The technologies integrated in the invention work together to provide an accurate and multidimensional diagnosis of scars. Each technology has been chosen for its unique capabilities to deliver non-invasive and highly detailed data, necessary to understand the complex healing processes and to predict the evolution 20 of the scars. Through their combination, you get the synergy necessary for a complete and precise diagnosis, integrating structural, cellular, and molecular information. The data collected from the different components are combined to create an image complete, which includes both physical structures and markers molecular (e.g. the combination of birefringence analysis with the information obtained from Raman spectroscopy can offer a more detailed picture of the activity of myofibroblasts and structural changes in the tissue). 5 4. Data Processing Unit (DPU) Integrated processor with artificial intelligence algorithms for the analysis of data collected by various sensors. The data is then processed by a central unit equipped with AI algorithms, trained on a large dataset of images and clinical data. 10 The AI-based algorithm integrates the data obtained from the analyses tissue, cellular and molecular, processed with the above technologies described. These algorithms are designed to identify patterns which indicate a potential unfavorable evolution of the scar, with particular attention to the presence and activity of my- 15 fibroblasts. They analyze and classify scars based on the probability of an unfavorable evolution, providing doctors clear and timely guidance for targeted interventions. As an output The system provides a risk score and suggestions for clinical management based on the analysis results. 20 Regarding the functioning of the diagnostic system of the invention and the related method of use, the system is applied directly to the patient's skin, without the need for take tissue samples. During the analysis, the various modules of the devices acquire optical and spectroscopic data, which are automatically processed by the data processing unit. The output consists of a detailed map of the tissue properties cicatricial and a predictive assessment on the evolution of the 5 scar. The integration of data from different technologies enable early and precise diagnosis, allowing for identify scars at risk of unfavorable evolution and intervene with targeted treatments. The system also offers the ability to monitor the effectiveness of treatments over time 10 applied. Phase 1: Data collection through imaging and analysis Molecular and cellular analysis of scars using OCT, polarimetry Muller matrix, Raman spectroscopy, diachrony analysis and MSOT. 15 Phase 2: Data processing using the predictive algorithm. Phase 3: Interpretation of results and definition of the plan therapeutic. The advantages of the system of the invention are as follows: 20 Accurate diagnosis: early identification of scars risk of unfavorable evolution with a focus on the activity of myo- fibroblasts. Personalizing care: targeted treatments and personalized based on the diagnosis. Continuous monitoring: ability to monitor the evolution of scars over time, with particular attention to the dynamics of 5 myo-fibroblasts. Practical examples of implementation Structure of the Machine Ergonomic and portable design: the device has a shape compact and portable, similar to an advanced medical cart, but with 10 a stable base and lockable wheels for easy movement. The The machine can be easily positioned near the patient, allowing analyses to be performed in a non-invasive manner. Adjustable mechanical arms: The device is equipped with one or plus lightweight, flexible, fully articulated mechanical arms. 15 These arms are designed to sit gently on top of the area of ​​the scar to be analyzed, such as the face, an arm or a leg. Integrated Technologies OCT: one of the arms is dedicated to OCT, with an optical module that 20 emits and collects low-coherence light to create images detailed views of the subcutaneous structures. Muller Matrix Polarimeter: Another arm is equipped with a polarimeter that analyzes the polarization properties of light reflected by the skin, helping to characterize scars. Diachrony Analysis: This module is designed to study 5 temporal variations of scar characteristics, monitoring subtle changes over time. Raman spectroscopy: a third arm integrates a system of Raman spectroscopy, used for non-invasive chemical analysis of the fabrics. 10 Optoacoustics: The optoacoustic system is integrated to generate high-resolution images based on induced acoustic waves from the light, adding an extra level of detail to the analysis. User Interface 15 Advanced Touchscreen: The device is equipped with a large touchscreen that allows the doctor to control and monitor all integrated technologies. The interface shows in real time images and data collected, with the possibility of overlay and compare the results of different technologies. 20 Integrated AI: Data analysis is assisted by a system of artificial intelligence that processes the collected information, providing a preliminary diagnosis and suggesting further analysis if necessary necessary. Analysis Area Scan Area: The scan area is designed to be flexible, adapting to different areas of the body. It can include safety sensors that ensure the patient is positioned 5 correctly and that the device does not come into direct contact with the skin, keeping the analysis completely non-invasive. Patient comfort: the analysis area is surrounded by soft and padded materials to ensure maximum comfort during the exam, with LED lights indicating the status of each module 10 technological. Aesthetics and general design Hi-Tech and clean look: The machine has a modern and minimalist, with smooth surfaces in white and gray, and accents metal. The colored LED lights indicate the operating status of the various 15 modules, adding a futuristic touch to the design. The invention system is composed of the following Modules: Module 1: Optical Coherence Tomography (OCT), this module captures high-resolution images of the internal structures of scars, using the reflection of light to generate 20 a tomographic image of the tissue. Schematic: including the source broadband light, the beam splitter, the sample (tissue scar), the reflection detector and the processor images. The system reflects light from the tissue and reconstructs the internal image of the scar. Module 2: Muller Matrix Polarimetry, this module measures the birefringence of scar tissue, detecting the variations 5 in the polarization of light through tissue. Diagram: comprising the polarized light source, the polarizer initial, the sample (scar tissue), the analyzer of polarization and the detector. The module measures the birefringence of the tissue, indicating the presence of structural abnormalities. 10 Module 3: Diachronic Analysis, this module measures the temporal changes in the optical and mechanical properties of the scar tissue, providing information on the dynamics of the healing. Diagram: including the acquisition system temporal data, the sample (scar tissue), and the 15 data processor. The module compares measurements at moments different to detect changes in the scar over time. Module 4: Raman Spectroscopy, this module analyzes the chemical composition of scar tissue, detecting the specific molecular vibrations of collagen, α-SMA and fibronectin 20 EDA. Scheme: including the laser source, the sample (tissue cicatricial), the Raman scatterer, and the spectroscopic detector. The system collects the Raman spectrum of the tissue, providing information on the chemical composition and activation of myo- fibroblasts. Module 5: Optoacoustic System, this module measures the elasticity and density of scar tissue using 5 laser pulses to generate acoustic waves detected by the transducer. Schematic: including the pulsed laser source, the sample (tissue cicatricial), and the acoustic transducer. The system detects the waves acoustics generated, providing a measure of the elasticity and tissue density. 10 Final Module: Complete Diagnostic System, unites all the previous modules into a single integrated system that processes data and images through an artificial intelligence unit, simplifying the user interface and providing accurate diagnoses. Complete diagram of the NovaInsight non-invasive diagnostic system, integrating all the 15 modules: OCT, Muller Matrix Polarimetry, Raman Spectroscopy, Optoacoustics, and Diachrony Analysis, connected to the central unit AI. The system analyzes scars in vivo, providing a comprehensive and predictive assessment. Examples of Realization 20 Example 1: Pre-operative evaluation of a scar hypertrophic A patient presents to the doctor with a scar hypertrophic on the arm, formed after an accidental trauma. Doctor decides to use non-invasive diagnostic system described to evaluate the scar and determine the treatment strategy most appropriate treatment. System preparation and positioning: the device 5 diagnostic of the invention is placed over the scar. The doctor applies a conductive gel to facilitate the transmission of opto-acoustic signals. Image and Data Acquisition: - OCT: It is used to acquire high-resolution images 10 resolution of the internal structure of the scar, revealing the organization and density of collagen fibers. - Polarimetry: measures the birefringence of the tissue, highlighting any misalignments of the collagen fibers that could indicate pathological scarring. 15 - Diachronic Analysis: consists in temporal monitoring of the scar, acquiring images and data at regular intervals to evaluate the evolution of scar tissue over time, observing cellular dynamics, in particular the variation in population and activity of myofibroblasts, and identifying 20 early signs of possible pathological development of the scar. - Raman spectroscopy: it is used to analyze the chemical composition of scar tissue, identifying the presence of activated myofibroblasts through the detection of α- SMA and EDA fibronectin. - Opto-acoustics: The opto-acoustic system measures the elasticity and the density of the tissue, providing additional information on the 5 scar stiffness. Data processing and AI analysis: all data acquired are sent to the central processing unit, where they are analyzed by artificial intelligence algorithms. AI compares the data with a database of previously analyzed scars and 10 ranked. Result and diagnosis: The diagnostic system provides a overall assessment, indicating that the scar presents structural and chemical characteristics compatible with an evolution unfavorable towards a hypertrophic scar. The doctor decides to 15 proceed with early treatment, including injections of corticosteroids and the application of a fractional laser, for prevent further thickening of the scar. Example 2: Post-operative monitoring of a scar Surgical 20 A patient undergoing plastic surgery presents for a post-operative check-up. The surgeon uses the diagnostic system to monitor the healing of the scar and prevent possible complications. Initial data acquisition: one week after surgery surgical, the diagnostic system is used to acquire a Initial data set on the developing scar. The OCT detects a good organization of the collagen fibers, while the 5 polarimetry and Raman spectroscopy indicate an absence of myo- activated fibroblasts. Medium-term monitoring: one month after surgery, the system is used again to monitor the scar. The AI ​​analysis compares the new data with the initial data, detecting a 10 slight increase in tissue stiffness, but no signs of unfavorable evolution. Final evaluation: three months after the intervention, the system diagnostic does not detect any sign of myofibroblast activation or abnormal increase in tissue density. The surgeon confirms that 15 the scar is healing properly, without the need for further interventions. Example 3: Identification of scars at risk of evolution unfavorable A patient with a history of keloid scarring presents with 20 a new scar formed after a burn. The doctor decides to use the diagnostic system to assess the risk of evolution into a keloid scar. Data acquisition and AI analysis: the invention is Raman spectroscopy was used to analyze the new scar. detects the presence of EDA fibronectin and high levels of α-SMA, key indicators of myofibroblast activation. OCT shows 5 an increase in tissue density, and polarimetry shows a significant misalignment of collagen fibers. Diagnosis and treatment plan: AI analysis classifies the scar as high risk of developing into a scar keloid. The doctor decides to start an aggressive treatment with 10 the use of silicone and corticosteroid injections, combined with laser therapy, to prevent the formation of a keloid. Follow-up: The diagnostic system is used during the Follow-up visits to monitor treatment response. Thank you. with early diagnosis and continuous monitoring, the scar is 15 successfully managed, avoiding the development of a keloid scar. Implementation for best results To achieve the best results, the invention should be integrated into the standard care protocol for patients at risk of develop pathological scars or for those affected by diseases 20 fibrotic. Below are some options to solve and improve the critical issues related to the specificity and sensitivity of the technologies involved: 1. Optimizing OCT for higher resolution and contrast OCT can sometimes suffer from limitations in resolution and in the contrast of the image, which can affect the ability to 5 Distinguish between different types of scar tissue. Implement wavelength-optimized light sources and post-processing algorithms advanced processing to improve image resolution. The use of speckle reduction and segmentation techniques AI-based automatic can increase contrast and specificity 10 in tissue visualization. 2. Increased sensitivity in Matrix polarimetry Muller The sensitivity of polarimetry can be limited in scars with small variations in birefringence. Use 15 polarizers with increased angular resolution capability and optical amplifiers to improve change detection minima in the polarization of light. The integration of algorithms AI-based filtering can help eliminate noise and improve measurement accuracy. 20 3. Diachronic analysis for greater temporal precision The accuracy in detecting temporal changes can be compromised by fluctuations in acquisition conditions. Implement environmental control systems to ensure safe conditions stable during repeated acquisitions. The integration of algorithms deep learning-based temporal analysis can improve the ability to detect minimal changes and provide more accurate predictions accurate on the evolution of the scar. 5 4. Improving the Specificity of Raman Spectroscopy The specificity of Raman spectroscopy can be reduced from the presence of background signals or interference from other components tissue. Apply "background subtraction" techniques to remove background signals and use wavelength lasers 10 multiple to obtain a greater depth of penetration and molecular specificity. Furthermore, the use of multivariate analysis of spectroscopic data can improve biomarker identification specific ones such as α-SMA and fibronectin EDA. 5. Increased accuracy in opto-acoustic analysis 15 Accuracy in measuring elasticity and density of the tissue can be influenced by variations in the response tissue acoustics. Implement broadband transducers with a greater acoustic sensitivity and develop compensation algorithms acoustics that can correct variations in the response of the 20 tissue. The use of opto-acoustic tomography techniques could provide detailed three-dimensional images for better assessment. The implementation of these technological solutions will improve the specificity and overall sensitivity of the invention system, making it an even more powerful and reliable tool for the diagnosis and study of scars and fibrotic diseases. 5 Adaptation for Telemedicine To adapt the device to this new demand, we can imagine a system where artificial intelligence (AI) analyzes the collected data and returns a simplified result and immediately understandable even for a non-healthcare worker. 10 This could include the use of simple symbols and color codes, avoiding complex images. 1. Interface with AI No complex images. The device does not display images. detailed results. Instead, the collected data is sent to 15 an integrated artificial intelligence system that processes and analyze the information. Simplified result. The AI ​​returns a very simple output. simple, like a three-color traffic light (green, yellow, red) for indicate "normal", "caution" and "problem" respectively, 20 accompanied by an intuitive symbol, such as a green tick, a dot yellow exclamation mark, or a red cross. Specific diagnosis. In addition to colors and symbols, AI provides a specific diagnosis in the form of a short text, such as "Scar stable,” “Monitor scar,” or “Intervention recommended.” 2. Simple and clear display 5 Minimal interface. The display on the device only shows the symbols and colors, with a clear and understandable textual diagnosis. No interpretation needed. The output is designed for be understandable without the need for medical expertise, ideal for use by non-healthcare personnel. 10 3. Use on patient Direct support on the skin. The operator places the device directly on the patient's skin, for example on the arm or on the face, and the device automatically starts scanning and analysis. 15 Immediate feedback. After a few seconds, the device view the simplified result. Conclusions The invention represents a significant advance in the field of non-invasive diagnostics, offering an integrated solution and 20 advanced for the evaluation of skin scars and diseases fibrotic. Through the innovative combination of technologies optical and spectroscopic, such as Optical Coherence Tomography (OCT), Muller Matrix Polarimetry, Raman Spectroscopy, Opto-acoustics and Diachronic Analysis, the invention allows to obtain a predictive and highly specific diagnosis of scars and healing processes. 5 The use of advanced artificial intelligence algorithms for Analysis of the collected data not only improves accuracy and specificity of diagnoses, but also allows for monitoring dynamic and personalized patient care. The invention is particularly useful not only in the clinical management of 10 scars, but also in the study of diseases characterized by a unregulated fibrosis, offering a powerful tool for research and early diagnosis of complex conditions. Thanks to its ability to integrate multiple diagnostic modalities in a single system, the invention has the potential to become a 15 essential tool in dermatology and surgery departments plastic and in burn treatment units. Furthermore, with the its applicability in the study of fibrosis in various tissues body, this technology opens new frontiers in research biomedical. 20 In summary, the invention not only innovates the approach to diagnosis and management of scars, but extends its potential for a wide range of clinical and research applications, contributing significantly to the improvement of care and understanding fibrotic diseases. In summary, the system includes an ergonomic handpiece connected to a modular mobile unit, integrating technologies 5 Optical Coherence Tomography (OCT), Muller Matrix Polarimetry, Raman Spectroscopy, Opto-acoustics and Diachrony Analysis, where the data collected by each module is analyzed by a unit of central processing equipped with artificial intelligence algorithms to provide a predictive diagnosis of the evolution of scars. 10 This integrated system allows for a complete evaluation and multidimensional scar treatment, combining different modalities diagnostics to obtain detailed information on the structure, composition and optical properties of scar tissue. The use of artificial intelligence algorithms for 15 data analysis significantly improves accuracy and the objectivity of the diagnosis, overcoming the limitations of the techniques traditional evaluation methods. The central processing unit can be configured to run deep learning algorithms and convolutional neural networks to 20 analysis of data and images collected from the modules, improving the accuracy and specificity of the diagnosis. The implementation of advanced machine learning techniques allows the system to identify complex and subtle patterns variations in the characteristics of scars that may escape the human eye, leading to greater accuracy in the prediction of scar evolution and in planning the treatment. 5 The Raman Spectroscopy module can be configured to detect scar-specific biomarkers, including α-SMA and fibronectin EDA, providing information on myo- fibroblasts and other molecular indicators of evolution cicatricial. 10 This ability to detect specific biomarkers at the molecular offers a significant advantage in understanding the biological processes underlying the formation and evolution of scars, allowing a more precise assessment of the risk of development of pathological scars and more personalization 15 effective treatments. The integration of multimodal technologies can enable the monitoring and study of wound healing processes and of diseases characterized by irregular fibrosis, such as pulmonary fibrosis, liver cirrhosis and chronic kidney disease. 20 This feature greatly extends the range of application of the system, making it a valuable tool not only for dermatology, but also for other medical specialties that deal with fibrotic pathologies, opening up new possibilities of research and improving understanding of these complex conditions. The central processing unit can be configured to analyze temporal changes in tissue properties 5 cicatricial through the analysis of diachrony, providing a dynamic and predictive assessment of wound healing and of the evolution of the scar. The ability to monitor and analyze changes over time represents a significant step forward in the management of 10 scars, allowing timely interventions and customization continue treatment based on the observed evolution. The diagnostic device can be configured for use in clinical field, particularly in the dermatology and surgery departments plastic, and burn treatment units, for the evaluation 15 pre-operative and post-operative scars. This versatility in clinical application makes the system a valuable tool for various medical specialties, improving the management of patients in various contexts and phases of treatment scars. 20 The diagnostic system of the invention may comprise a handpiece ergonomic connected to a modular mobile unit. This ergonomic handpiece can be designed to be easily handled by the operator, allowing positioning precise and comfortable on the patient's scar tissue. The modular mobile unit can be designed to accommodate and 5 integrate the different diagnostic technologies used by the system, including Optical Coherence Tomography (OCT), Polarimetry Muller Matrix, Raman Spectroscopy, Opto-acoustics and Diachronic Analysis. Each module can be designed to operate in a 10 independent, but can also be coordinated with other modules for provide a comprehensive, multidimensional assessment of scars. This unit can be easily moved and placed near to the patient, allowing quick and convenient access during the exam. 15 In some cases, the modular mobile unit can be equipped with Lockable wheels to ensure stability during use. Advantageously, the ergonomic handpiece can be designed to be placed directly on the patient's skin, example on the arm or face, and the scan automatically starts 20 and the analysis once positioned. This can eliminate the need for invasive surgery or taking tissue samples, making the whole process more comfortable and less stressful diagnosis for the patient. In addition, the ergonomic design of the handpiece can make it easier to use. by the operator, allowing precise positioning and a careful control during the exam. Furthermore, the modular mobile unit can be equipped with a system 5 centralized control that manages the acquisition and data processing, ensuring efficient operation and synchronized diagnostic system. The diagnostic system of the invention integrates the Optical Coherence Tomography (OCT) technology. 10 OCT is a high-resolution optical imaging technology that allows you to obtain detailed images of the internal structures of the tissues, similar to a non-invasive "optical biopsy." This technology is particularly useful for the analysis of scars as it can reveal the organization of the fibers of 15 collagen, tissue architecture and overall integrity of the scar. This ability is essential to identify the characteristics structural which may be indicative of an evolution unfavorable, such as the formation of hypertrophic scars or keloids. 20 In the system of the invention, the OCT can be optimized for improve image resolution and contrast. Advantageously, light sources can be used optimized for OCT, emitting light at wavelengths specifications to improve image resolution. These light sources can be selected for 5 maximize light penetration into scar tissue, allowing for more detailed images of the structures inside of the scar. Furthermore, in the system of the invention, they can be implemented advanced post-processing algorithms to improve 10 further improve the quality of OCT images. These algorithms may include "speckle" techniques. reduction" to reduce noise in images and improve the contrast, and automatic segmentation techniques based on artificial intelligence to accurately identify and delineate 15 tissue structures in OCT images. These optimizations can significantly improve the system's ability to detect and characterize scars, providing a more accurate and detailed diagnosis. Muller Matrix Polarimetry is used for 20 analyze the anisotropic optical properties of scar tissue, providing detailed information on the orientation of the fibers of collagen and the presence of structural disorganizations that they could indicate an unfavorable evolution of the scar. According to the present invention, the Polarimetry module Muller matrix can be equipped with a polarizer with a increased angular resolution and optical amplifier capabilities to improve the detection of minimal changes in 5 polarization of light, this can allow to obtain more precise and reliable measurements of birefringence properties of scar tissue. Furthermore, in the system of the invention, they can be implemented intelligence-based filtering algorithms 10 artificial to eliminate noise and improve the accuracy of the Muller Matrix Polarimetry measurements. These algorithms can be trained on a large dataset of images and clinical data of scars, allowing to identify complex patterns associated with scars with potential evolution 15 unfavorable. In the diagnostic system of the invention according to the present invention, Raman Spectroscopy technology is integrated. This technology is used for chemical analysis not invasive of tissues, allowing to detect and quantify 20 specific molecular biomarkers. In particular, Raman spectroscopy can be used to identify the presence of activated myofibroblasts in the tissue cicatricial, through the detection of specific biomarkers such as α-SMA (alpha-smooth muscle actin) and EDA fibronectin. These biomarkers are key indicators of the activation of myofibroblasts, crucial cells in the healing process and 5 in the formation of pathological scars such as hypertrophic scars and keloids. Furthermore, Raman Spectroscopy includes the laser source, the sample (scar tissue), the Raman scatterer, and the detector spectroscopic. 10 The system collects the Raman spectrum of the tissue, providing information on the chemical composition and activation of myo- fibroblasts. Advantageously, the diagnostic system of the invention can use "background subtraction" techniques to improve the 15 specificity and sensitivity of Raman spectroscopy. These techniques can be used to remove the non-specific background signals, improving the ability to detect and quantify specific biomarkers such as α-SMA and fibronectin EDA. Furthermore, multivariate analysis of spectroscopic data can 20 be used to further improve the identification of specific biomarkers. The diagnostic system of the invention integrates the Opto-acoustic technology, this technology exploits the interaction between light and sound to generate opto-acoustic signals, which can be used to obtain high-resolution images of tissues. 5 In particular, Opto-acoustics can be used to measure the elasticity and density of scar tissue, providing detailed information on the stiffness and structure of the fabric. The Opto-acoustics module may include a system of laser illumination, an acoustic transducer and a system 10 signal processing. The laser illumination system can be designed to emit pulses of light at a specific wavelength, optimized to generate acoustic waves in scar tissue. The acoustic transducer can be designed to detect the 15 acoustic waves generated by light and converting them into signals electrical, the signal processing system can be designed to analyze electrical signals and generate images opto-acoustics of scar tissue. Advantageously, the diagnostic system of the invention can 20 use broadband transducers to improve sensitivity and the resolution of opto-acoustic images, these transducers can be designed to detect a wide range of frequencies acoustics, allowing to obtain high resolution images of the scar tissue. Additionally, compensation algorithms can be implemented acoustics to correct variations in tissue response, 5 further improving measurement accuracy. According to the present invention, in the diagnostic system The invention integrates the Diachronic Analysis technology. This technology is used to monitor changes temporal in the properties of scar tissue, providing a 10 dynamic and predictive assessment of wound healing and of the evolution of the scar. The Diachronic Analysis module can be configured to acquire images and data at regular intervals, allowing you to observe how the cellular and tissue components, in particular the 15 myo-fibroblasts, they change over time. This module may include a time acquisition system of data, which can be designed to collect data in a continuously or at predefined intervals. Additionally, a data processing system can be implemented 20 data to analyze temporal changes and provide an assessment dynamics of scar evolution. In particular, the diagnostic system of the invention can use intelligence-based temporal analysis algorithms artificial, these algorithms can be trained on a large dataset of images and clinical data of scars, allowing to 5 identify complex patterns associated with scars with potential unfavorable evolution. The central processing unit of the diagnostic system of the invention, can be designed to perform algorithms of advanced artificial intelligence for data and information analysis 10 images collected from various modules, this unit can be equipped with a high-performance processor and large memory capacity, designed to handle large amounts of data and perform complex calculations in real time. The artificial intelligence algorithms used in the unit 15 central processing can include deep learning algorithms and convolutional neural networks, such algorithms can be trained on a large dataset of images and clinical data of scars, allowing to identify complex patterns associated with scars with potential unfavorable evolution. 20 Furthermore, deep learning algorithms can be used to analyze images collected by OCT modules, Muller Matrix Polarimetry, Raman Spectroscopy and Opto- acoustics. These algorithms can be designed to recognize specific features in images, such as the structure of the collagen fibers, the orientation of the fibers, the presence of myo- activated fibroblasts and the optical and mechanical properties of the tissue 5 cicatricial. Furthermore, artificial intelligence algorithms can be used to analyze the data collected from the form Diachronic Analysis, these algorithms can be designed to detect temporal changes in tissue properties 10 cicatricial, providing a dynamic and predictive assessment of the evolution of the scar. In short, the central processing unit and the algorithms artificial intelligence of the invention diagnostic system can provide a more complete and accurate diagnosis of scars, 15 significantly improving the clinical management of scars and of fibrotic diseases. In the diagnostic system of the invention, according to the present invention, a simplified interface with AI analysis is integrated which returns a simplified result that is also understandable for 20 non-healthcare workers, this interface is designed to be intuitive and easy to use, allowing the operator to start and Monitor your analytics in just a few simple steps. The interface includes:  a visual display showing the analysis results in real time, using simple symbols and color codes to indicate the condition of the scar and the risk of unfavorable evolution; 5  a touch-screen input system, designed to be resistant and reliable, which allows the operator to select analysis options and view the results. The simplified result provided by AI analysis can include 10 the use of simple symbols and color codes. For example, a green check mark may indicate that the the scar is stable and shows no signs of unfavorable evolution, while a yellow exclamation mark may indicate that the scar requires closer monitoring; a red cross symbol can 15 indicate that the scar shows signs of unfavorable evolution and may require therapeutic intervention. Advantageously, the simplified interface with AI analysis of the diagnostic system of the invention can provide immediate feedback and understandable to operators, improving efficiency and 20 the effectiveness of scar diagnosis. In some aspects, the diagnostic system of the invention may be configured for use in a clinical setting, particularly in dermatology, plastic surgery and treatment units of burns. In the dermatology department, the system of the invention can be used for the diagnosis and monitoring of scars 5 skin conditions caused by various dermatological conditions, such as acne, dermatitis, skin infections and autoimmune diseases. Furthermore, the system can be used to evaluate the effectiveness of dermatological treatments, such as laser therapies, topical medications and systemic treatments, monitoring changes 10 in the optical, mechanical and chemical properties of the fabric cicatricial over time. In plastic surgery departments and treatment units of burns, the system of the invention can be used for evaluate patients' scars before and after surgery 15 surgical procedures to predict the risk of scar formation pathological and to monitor the evolution of scars over time, This can allow surgeons to plan interventions surgical procedures more effectively, to intervene promptly in case of unfavorable evolution of the scars and to monitor 20 the effectiveness of post-operative treatments. In summary, the diagnostic system of the invention can provide an effective means for evaluating and monitoring scars in various clinical settings, significantly improving the clinical management of scars and fibrotic diseases. The diagnostic system of the invention, according to the present invention, offers numerous advantages over technologies 5 existing diagnostics for the evaluation of skin scars. One of the main advantages is its diagnostic accuracy, thanks to the integration of various advanced technologies, such as OCT, Muller Matrix Polarimetry, Raman Spectroscopy, Opto- acoustics and Diachronic Analysis, the system of the invention can 10 provide an extremely quantitative and qualitative assessment precise analysis of the optical, mechanical and chemical properties of fabrics cicatricial. This allows us to precisely identify the tissue and cellular components of scars, providing a more accurate and detailed diagnosis than conventional diagnostic methods 15 traditional. Another significant advantage of the invention system is its non-invasiveness, the system is designed to operate entirely in vivo, eliminating the need to take samples of tissue or using exogenous biomarkers, this makes the whole 20 more comfortable and less stressful diagnostic process for the patient, reducing the risk of complications associated with procedures invasive. Furthermore, the non-invasiveness of the system of the invention allows to perform repeated analyses over time, providing an assessment dynamics of scar evolution. Finally, the system of the invention offers a predictive capability 5 advanced thanks to the use of artificial intelligence algorithms for By analyzing the collected data, the system can identify patterns scar-associated complexes with potential evolution unfavorable. In summary, the diagnostic system of the invention offers a 10 superior diagnostic accuracy, non-invasiveness and capacity advanced predictive compared to existing diagnostic technologies for the evaluation of skin scars. These advantages can significantly improve the clinical management of scars and of fibrotic diseases, helping to improve the quality of life 15 treatments and reduce healthcare costs associated with these conditions. Some forms of have been illustrated and described above. preferred embodiments of the present invention: obviously, to the experts in the field will immediately find numerous evident variants and modifications, functionally equivalent to the previous ones, which 20 fall within the scope of protection of the invention as highlighted in the attached claims.

Claims

CLAIMS 1. A non-invasive diagnostic system for the assessment of scars, comprising at least one ergonomic handpiece operatively connected to at least one modular mobile unit; wherein said ergonomic handpiece and said modular mobile unit comprise: - at least one integrated Optical Coherence Tomography (OCT) module; - at least one Muller Matrix Polarimetry module; - at least one Raman Spectroscopy module; - at least one Opto-acoustics module; - at least one Diachronic Analysis module; - at least one Multispectral Optical Tomography (MSOT) module; and - at least one central processing unit equipped with artificial intelligence algorithms configured to analyze the data collected by said modules.

2. The system of claim 1, wherein the Optical Coherence Tomography (OCT) module is designed to capture high-resolution images of the internal structures of scars by using the reflection of light to generate a tomographic image of the tissue, said OCT module comprising a broadband light source, a beam splitter, a scar tissue sample, a reflection detector, and an image processor, the system reflecting light from the tissue and reconstructing the internal image of the scar.

3. The system of claim 1 or 2, wherein the Muller Matrix Polarimetry module is designed to measure the birefringence of scar tissue by detecting changes in the polarization of light through the tissue, said module comprising a polarized light source, an initial polarizer, a scar tissue sample, a polarization analyzer, and a detector, said module measuring the birefringence of the tissue, indicating the presence of structural abnormalities.

4. The system of claim 1, 2, or 3, wherein the Diachronic Analysis module is designed to measure temporal changes in the optical and mechanical properties of scar tissue, providing information on the dynamics of healing, said module comprising a temporal data acquisition system, a scar tissue sample, and a data processor, said module comparing measurements at different times to detect changes in the scar over time.

5. A system according to any preceding claim, wherein the Raman Spectroscopy module is designed to analyze the chemical composition of scar tissue by detecting the specific molecular vibrations of collagen, α-SMA, and fibronectin EDA, said module comprising a laser source, a scar tissue sample, a Raman scatterer, and a spectroscopic detector, the module collecting the Raman spectrum of the tissue, providing information on the chemical composition and activation of myofibroblasts.

6. A system according to any preceding claim, wherein the Opto-Acoustic system module is designed to measure the elasticity and density of scar tissue using laser pulses to generate acoustic waves detected by the transducer, said module comprising a pulsed laser source, a scar tissue sample, and an acoustic transducer, said module detecting the generated acoustic waves, providing a measure of the elasticity and density of the tissue.

7. A system according to any preceding claim, wherein the Multi-spectrum Optical Tomography (MSOT) module is designed to combine the spatial resolution of ultrasound with optical sensitivity, allowing three-dimensional visualization and quantification of specific biomarkers in scar tissue, such as blood oxygenation and the distribution of specific proteins, the MSOT module providing crucial information on the functional status of the scar, which, combined with tissue and cellular data, allows a comprehensive assessment of the risk of adverse evolution.

8. A system according to any preceding claim, wherein the central processing unit is designed to unite all the preceding modules into a single integrated system that processes data and images via an artificial intelligence unit, simplifying the user interface and providing accurate diagnoses, said central processing unit analyzing scars in vivo, providing a comprehensive and predictive assessment.

9. A system according to any preceding claim, wherein the central processing unit is configured to execute deep learning algorithms and convolutional neural networks for analyzing the data and images collected by the modules.

10. A system according to any preceding claim, configured for use in a clinical setting, particularly in dermatology, plastic surgery, and burn treatment units, for pre-operative and post-operative scar assessment.

11. A method for the non-invasive assessment of skin scars, comprising acquiring data from a scar using the non-invasive diagnostic system according to any of the preceding claims, the method comprising analyzing the acquired data using artificial intelligence algorithms to provide a predictive diagnosis of the evolution of the scar.

12. A method according to claim 11, wherein the data acquisition comprises the use of Optical Coherence Tomography (OCT), Muller Matrix Polarimetry, Raman Spectroscopy, Optoacoustics and Diachrony Analysis technologies.

13. A method according to claim 11 or 12, wherein the data analysis using artificial intelligence algorithms comprises running deep learning algorithms and convolutional neural networks 10.

14. A method according to any of claims 11 to 13, wherein the data acquisition comprises detecting scar-specific biomarkers, including Ι'α-SMA and fibronectin EDA, by Raman Spectroscopy.

15. A method according to any of claims 11 to 14, further comprising analyzing temporal changes in scar tissue properties through Diachronic Analysis to provide a dynamic assessment of scar evolution.