Modular multi-scanning device and method

Abstract

The present invention relates to a modular multimodal imaging system for scanning and imaging cutaneous, subcutaneous, superficial abnormalities across external and internal organs or regions of the body, comprising a modular multimodal imaging device including a scanning unit comprising detachable scanning head including at least two imaging modules adapted to carry out different cutaneous and subcutaneous scanning modalities, a controlling unit adapted to control said at least two imaging principle, and a processing unit adapted to command said controlling unit to activate or combine at least two scanning and imaging modalities simultaneously or consecutively to capture at least two simultaneous or consecutive images data sets, characterized in that said processing unit is further adapted to retrieve the simultaneously or consecutively captured images and analyse said image data sets to predict the presence of cutaneous and subcutaneous abnormalities based on the aggregated imaging data.

Description

[0001] MODULAR MULTI-SCANNING DEVICE AND METHOD

[0002] Technical Field

[0003] The present invention relates to a modular multi-scanning device and a scanning method permitting detection and early detection of cutaneous, subcutaneous, superficial, and internal abnormalities. The device is designed for both external and internal applications, including but not limited to body cavities such as the vagina, rectum, and other accessible internal regions. Preferably, the invention is a modular, handheld, multi-scanning device capable of accommodating different imaging modalities. More particularly, the device of the present invention is a versatile, multi-purpose handheld scanner for detecting or facilitating the early detection of subcutaneous, cutaneous / superficial, and internal abnormalities.

[0004] Background of the art

[0005] The early detection of abnormalities, both cutaneous, on the skin’s surface, and subcutaneous, beneath the skin, is crucial for improving patient outcomes, as it enables timely intervention and increases the chances of successful treatment. Tumours, abnormalities, and other cutaneous or subcutaneous issues are often difficult to diagnose in their early stages using conventional methods.

[0006] Early detection can lead to less invasive treatments, better prognoses, and reduced healthcare costs. Therefore, a device that can non-invasively detect and monitor these abnormalities in real time is of significant clinical value and personal selfcare.

[0007] While there are conventional devices and method relating to various imaging modalities such as thermal, visual, ultrasonic, terahertz, transillumination, and elasticity imaging)and their respective applications in medical diagnostics, there has not yet been a comprehensive system integrating multiple modalities in a modular, complementarysystem which uses a method for using temporal information for early diagnosis of abnormalities.

[0008] For example, document US10117617 relates to a device and a method for early detection of pathophysiological conditions originating from skin or localized tissues. More particularly, it includes a device with two sensors capable of detection of latent pathogenic disease. A drawback of this system is that it is only for latent pathogenic disease skin conditions and is not adapted to other types of disease apart from skin, such as different type of cancers and abnormalities in depth. Moreover, while it provides two sensors, it lacks absolute modularity permitting to carry out an acute scanning of each disease individually with a single device. Moreover it is limited to abnormalities on the surface not in depth and their method does not consider the temporal information for prediction.

[0009] Also, document EP3020329 describes a device similar to the previous one dedicated for dermatology, and detecting the skin conditions, not other disease. This scanner similar to our work propose the exchangeable heads. In this patent their mean by exchangeable heads are heads with different geometrical shape such as contact head with conical or truncated pyramid shape for proper placement on the skin, but their camera does not change. Furthermore, in this invention they only use visual camera and they do not use the combination of different sensors.

[0010] Document US 2022 / 0061671 A1 describes a portable handheld imaging system in which an optical portion includes a white light imaging channel and a fluorescence imaging channel with corresponding illumination sources, filters and image sensors, and a processor configured to output a representation of the target surface to a display. It further discloses a modular housing concept in which an optical portion is releasably received by a base portion, and embodiments may include additional sensors such as an ambient light sensor and an inertial sensor.On the other hand, Document US 2020 / 0196869 A1 describes a handheld biophotonic imaging device using narrow band illumination and an imaging sensor to acquire tissue images, and a computing device configured to process the acquired images to generate diagnostic information, including tracking of tissue maps over multiple sessions and producing diagnostic outputs based on image analysis.

[0011] However, the devices disclosed in these documents do not permit both superficial and subcutaneous imaging.

[0012] In this regard, a primary object of the invention is to solve the above-mentioned problems and more particularly to provide a device and a method adapted to perform dynamic multimodal imaging that detects not only surface abnormalities but also deeper tissue abnormalities and abnormalities within accessible internal organs, enabling the early detection of a broader range of diseases beyond just skin-related conditions.

[0013] Another object of the invention is to provide a device, and a method adapted for different applications and disease diagnoses.

[0014] Summary of the invention

[0015] The above problems are solved by the present invention which is a scanning device which integrates at least two distinct imaging modules implementing different imaging principles include reflection based, transmission based, emission based and excitation based. Each modality provides complementary information that, when combined, offers a comprehensive and accurate assessment of both cutaneous and subcutaneous abnormalities in both external and internal organs. The different imaging techniques serve to capture various physical characteristics of the tissue, such as temperature, morphology, density, and stiffness, which are indicative of abnormal tissue behavior and pathology. The invention provides a device, and a method adapted to combine various imaging technologies with clinically relevant information and temporal data, utilizing artificial intelligence methods for the early diagnosis of diseases.More particularly, the present invention relates to a modular multimodal imaging system comprising an interchangeable scanning head that provides at least two imaging modules implementing at least two different imaging principles. In particular, the present invention provides a transmission based imaging module in which an emitting submodule is positioned on a first side of a target body portion and a receiving submodule is positioned on a second side opposite the first side to detect energy transmitted through the target body portion, and the scanning head is configured to maintain said emitting submodule and receiving submodule on opposite sides during acquisition. The processing unit is configured to co register a transmission based image data set with at least one other image data set acquired using a different imaging principle and to analyze aggregated imaging data for prediction of abnormalities. Accordingly, the present invention enables complementary assessment of superficial and subcutaneous structures by combining transmission based information with additional imaging information acquired by the same system.

[0016] The invention achieves the technical effect by modifying its functionality through interchangeable heads. The device features exchangeable heads, each with a distinct shape, imaging modalities, and electronics, enabling the scanning of various parts of the body, both internal (such as the cervix, vagina, prostate, etc.) and external (such as the skin, breast, head, and neck). The cameras and sensors on each head are modular, allowing them to be easily exchanged between different heads, providing versatile and efficient diagnostic capabilities.

[0017] A first aspect of the invention relates to a modular multimodal imaging system for scanning and imaging the anatomical regions of interest, including cutaneous, subcutaneous, or superficial structures of internal or external organs in a patient, comprising: a modular multimodal imaging device including an interchangeable scanning head specifically presenting a particular arrangement of at least two imaging modules each supporting a distinct imaging modality, and a device body, wherein the scanning head is designed to perform predetermined scanning modalities for detecting presence of abnormalities in cutaneous, subcutaneous, or superficial tissues of internal or external organs, wherein the at least two imaging modules comprise imagingmodules implementing at least two different imaging principles selected from: (i) a reflection-based imaging module configured to emit energy toward a target body portion and detect reflected energy from the same side of the target body portion, (ii) a transmission-based imaging module comprising an emitting submodule configured to be positioned on a first side of the target body portion and a receiving submodule configured to be positioned on a second side opposite the first side to detect energy transmitted through the target body portion, wherein the scanning head is configured to maintain the emitting submodule and receiving submodule on opposite sides during acquisition, (iii) an emission-based imaging module configured to detect energy emitted from the target body portion, (iv) an excitation-based imaging module configured to emit an excitation energy toward the target body portion and to detect, with a corresponding receiving submodule, a response signal generated in the target body portion in response to the excitation energy, wherein at least one of the at least two imaging modules is the transmission based imaging module, a controlling unit adapted to control the at least two imaging modules, and a processing unit adapted to command the controlling unit to activate or combine at least two imaging modules simultaneously or consecutively to capture at least two simultaneous or consecutive images data sets, characterized in that the processing unit is further adapted to retrieve the simultaneously or consecutively captured image data sets, co register a image data set from one imaging principle with at least one other image data set acquired using a different imaging principle, and analyze aggregated imaging data to predict the presence of abnormalities in cutaneous, subcutaneous, or superficial tissues of internal or external organs.

[0018] Advantageously, the at least two scanning modules implement at least two different imaging principles selected from reflection-based imaging, transmission based imaging, emission-based imaging, and excitation-based imaging, and wherein the imaging modules are selected from the following groups: (i) reflection based imaging modules, comprising an optical reflectance imaging module, an infrared based reflectance imaging module, an ultrasound pulse echo imaging module, a microwave reflectance imaging module, a terahertz reflectance imaging module, and anelectromagnetic reflectance imaging module, elastography, (ii) transmission based imaging modules, comprising a transillumination imaging module, an ultrasound transmission imaging module, an acoustic tomography module, a microwave transmission imaging module, and a terahertz transmission imaging module, (iii) emission based imaging modules, comprising a thermal imaging module, a contact thermography film module, a fluorescence imaging module, a photoacoustic imaging module, a magnetic resonance imaging module, a gas emission imaging module, and a bioluminescence imaging module, (iv) excitation based imaging modules, comprising an excitation fluorescence imaging module, a stimulated emission imaging module, and an optically excited spectroscopy imaging module.

[0019] Preferably, the processing unit is embedded in a remote computer system different from the modular multimodal imaging system device, and wherein the modular multimodal imaging system device is configured to transmit to the remote computer system at least two image data sets acquired using different imaging principles together with head specific calibration data, and wherein the remote computer system is configured to co register the at least two image data sets and output aggregated imaging data for display on the modular multimodal imaging system device.

[0020] According to a preferred embodiment of the present invention, the modular multimodal imaging system further comprises a memory embedded in the device or via cloud service and adapted to store the image data sets captured over multiple scanning sessions wherein the processing unit is configured to perform pseudonymization of patient identifiers on the device body before storage or transmission and to encrypt the stored and transmitted image data sets, and wherein the processing unit is further configured to align a later scanning session to an earlier scanning session using at least one of anatomical landmarks, fiducial markers associated with the scanning head, and a head pose estimate, to enable longitudinal comparison of aggregated imaging data.

[0021] In a preferred manner, the processing unit is adapted to process and compare aggregated imaging data derived from multiple scanning sessions stored in the memory, wherein the multiple scanning sessions comprise at least two image data sets acquiredusing different imaging principles, and to generate a diagnosis message by quantifying a change over time of at least one abnormality metric within a zone of interest defined in a co registered spatial reference frame.

[0022] According to a preferred embodiment of the present invention, the processing unit is adapted to process and compare multiple image data sets of different modalities captured along a similar temporality within a same scanning session or within a predefined time window, stored in the memory and generate a diagnosis message based on the evolution of a zone of interest in the captured image sets, after co registration of the different modalities to a common spatial reference frame, and based on aggregated imaging data.

[0023] Preferably, the processing unit is adapted to display the diagnosis together with a co registered multimodal overlay or fused abnormality map on a display unit.

[0024] In a preferred manner, the modular multimodal imaging system further comprises an additional sensor configured to measure environmental parameters selected from the group comprising temperature, humidity, light intensity, and other relevant ambient conditions, wherein the measured data is used for calibration of the imaging modules by normalizing at least one acquisition parameter or background signal, rejecting at least one image frame when an environmental parameter exceeds a threshold, and storing the measured data with the image data sets for longitudinal comparison.

[0025] According to a preferred embodiment of the present invention, the modular multimodal imaging system further comprises a motion and orientation sensing system, including but not limited to an accelerometer, for determining the spatial positioning, movement, and orientation of the device wherein the processing unit is configured to perform motion gating by discarding or down weighting image frames captured when motion exceeds a threshold, and to use a pose estimate derived from the motion and orientation sensing system to improve co registration between image data sets acquired using different imaging modalities or imaging principles.Preferably, the processing unit can apply Al-driven computational models, including deep learning-based anomaly detection, feature extraction, and multimodal fusion, to process and analyze image data sets, enhancing diagnostic accuracy, reducing artifacts, and improving clinical decision-making, wherein the Al driven computational models take as input at least two image data sets acquired using different imaging principles and co registered to a common spatial reference frame, the at least two image data sets comprising at least one transmission based image data set and at least one of a reflection based image data set or an emission based image data set, and wherein the multimodal fusion comprises feature level fusion by combining intermediate representations extracted from the at least two co registered image data sets, and wherein the processing unit is configured to use at least one of the image data sets to perform artifact correction or calibration of another image data set prior to the feature level fusion, and to output at least one of an abnormality score map and an uncertainty metric.

[0026] In a preferred manner, the modular multimodal imaging system further comprises a contrast enhancement subsystem comprising a chemical applicator integrated in the scanning head and configured to deliver a metered quantity of an agent to a target body portion, and wherein the processing unit is configured to acquire at least one baseline image data set before delivery and at least one post delivery image data set after delivery and to compute a differential map between the baseline and post delivery image data sets as part of the aggregated imaging data, and wherein the system further comprises at least one additional enhancement feature selected from the group comprising: a mechanical compression system configured to stabilize tissue and set or measure tissue thickness for transmission based acquisition, a thermal regulation module for temperature based noise reduction, an automated gel application system for optimizing acoustic imaging, and different light spectrum for better visualization.

[0027] Advantageously, the system is configured to mitigate and or correct photon scattering for increasing subsurface visibility by applying one or more techniques comprising: (i) time resolved acquisition using pulsed near infrared illumination and timegated detection or temporal weighting to preferentially retain earlier arriving photons relative to later arriving photons, (ii) angular selectivity using at least one of collimated illumination optics, a detection side collimator, a telecentric detection configuration, spatial filtering, or an adjustable aperture configured to limit numerical aperture and reduce wide angle scattered light, (iii) spectral selectivity using at least one near infrared wavelength band and at least one wavelength matched optical filter to suppress out of band light and reduce scattering effects, (iv) polarization selectivity using polarized illumination and an analyzing polarizer on the detection path in a parallel and or crossed configuration to reduce contributions from depolarized multiply scattered photons, (v) spatial frequency selectivity using structured illumination and demodulation to suppress diffuse background, and (vi) computational scatter correction using head specific calibration data and at least one of a light transport model, a calibrated phantom based correction, regularized inverse reconstruction, deconvolution, or multi condition fusion across at least two acquisition conditions selected from wavelength, polarization state, time gating, illumination pattern, and detector numerical aperture.

[0028] A second aspect of the invention is a modular scanning kit comprising the modular multimodal imaging system of the first aspect of the invention and multiple detachable and interchangeable scanning heads each configured for specific anatomical regions, wherein each scanning head is releasably couplable to the device body via the interface, and wherein each scanning head comprises at least two imaging modules implementing at least two different imaging principles as defined in the first aspect, and further comprises a head identifier and head specific calibration data readable by the processing unit, the kit being characterized in that the multiple scanning heads comprise at least: a first scanning head for external organ scanning, the first scanning head comprising a transmission based imaging module including a light emitting submodule configured to be positioned on a first side of a target body portion and a light receiving submodule configured to be positioned on a second side opposite the first side, the first scanning head further comprising an opposed module arrangement adapted to hold the submodules on opposite sides during acquisition, and a second scanning head for an accessible internal body cavity, the second scanninghead comprising a distal tip geometry adapted for insertion into the cavity and comprising at least one of a reflection based imaging module and an emission based imaging module, and a sterile barrier or disposable cover, wherein the processing unit is configured to load the head specific calibration data based on the head identifier and to co register image data sets acquired with the attached scanning head for longitudinal comparison across scanning sessions.

[0029] A third aspect of the invention is a use of a modular scanning kit of the second aspect of the invention for specific medical applications, including oncology, dermatology, ophthalmology, and other specialized health assessments, wherein the scanning heads are selected from the group comprising those designed for detecting breast abnormalities for breast cancer detection, prostate cancer, cervix cancer, ovarian cancer, thyroid cancer, colon and rectal cancer, pancreatic cancer, kidney cancer, esophageal cancer, stomach cancer, testicular cancer, gallbladder cancer, rectal cancer, soft tissue sarcoma, head & neck cancers(oral cancer, throat cancer, laryngeal cancer, nasopharyngeal cancer, sinus cancer), eye health checks, prostate cancer screening, and hair and scalp health analysis.

[0030] A fourth aspect of the invention is a modular scanning method using the modular scanning kit of the second aspect of the invention comprising the steps of receiving multiple simultaneous or consecutive images data of a target body portion with the modular scanning kit equipped with a scanning head adapted to the target body portion, retrieving the simultaneously or consecutively captured image data sets and processing the image data sets to generate aggregated imaging data and output at least one of a fused image, a feature map, a score map, or an uncertainty map.

[0031] Advantageously, the processing unit uses at least one imaging modality for artifact correction or bias reduction or image quality enhancement of another modality.

[0032] In a preferred manner, the processing unit activates a specific combination of two of more scanning and imaging modules to perform predetermined imaging modalities for cutaneous, subcutaneous, or other target body portions, wherein theprocessing unit co registers the corresponding image data sets and combines them to generate the aggregated imaging data.

[0033] Preferably, the processing unit activates at least a first specific scanning modality of a first head and, consecutively, a second modality of a second specific scanning head and combines the two or more images to generate aggregated imaging data.

[0034] Advantageously, the processing unit uses related acquisition metadata as extra information to adjust processing parameters, the related acquisition metadata comprising at least one of patient positioning information, head identifier, acquisition settings, or environmental sensor measurements.

[0035] Therefore, the invention is modular not only in terms of its imaging modalities but also in the interchangeable heads that allow the device to be tailored to specific diagnostic applications. These heads are designed to be swapped easily, providing a highly adaptable tool that can be used for a wide range of conditions. The ability to use different heads, each optimized for specific diagnostic purposes, makes the device particularly innovative and versatile compared to existing technologies that typically rely on fixed imaging modalities or equipment.

[0036] The device’s modularity and interchangeable heads reduce the need for multiple separate devices in a clinical setting, improving both cost-effectiveness and operational efficiency. Healthcare professionals can easily switch between diagnostic heads to tailor the imaging modality to the specific patient or condition, making it ideal for use in a variety of settings, from routine check-ups to specialized screenings for different types of cancer, skin diseases, and other conditions.

[0037] Brief description of the drawings

[0038] Further particular advantages and features of the invention will become more apparent from the following non-limitative description of at least one embodiment of the invention which will refer to the accompanying drawings, whereinFigure 1 schematically represents the device of the present invention, and Figures 2A to 2C represent various heads of the present invention.

[0039] Detailed description of the invention

[0040] The present detailed description is intended to illustrate the invention in a non-limitative manner since any feature of an embodiment may be combined with any other feature of a different embodiment in an advantageous manner.

[0041] The problems described in the prior art description above are solved by the present invention which is schematically illustrated in Figure 1 showing the first aspect of the invention which is a modular multimodal imaging system for scanning and imaging cutaneous and subcutaneous portions of a patient's body.

[0042] The modular multimodal imaging system comprises a modular multimodal imaging device 10 including an interchangeable scanning head 12 specifically presenting a particular arrangement of at least two imaging modules 121 particularly adapted to carry out predetermined cutaneous and subcutaneous scanning modalities which will be described later more in details and a device body 11 preferably housing the electronics. It also comprises a particular universal interface 13 permitting to attach, detach replace and connects the interchangeable head to the body 11 without difficulties.

[0043] The device body also preferably comprises a power source 113 and a wireless communication module 114

[0044] According to the preferred embodiment, the device body 11 houses a controlling unit 112 adapted to control the two imaging modules 121, and a processing unit 111, which can be embedded in a remote computer system such as a cell phone, different from the modular multimodal imaging system device (this is not shown in the figure since the processing unit is embedded), adapted to command the controlling unit 112 to activate or combine the imaging modalities simultaneously or consecutively to capture at least two simultaneous or consecutive images data sets.Processing unit 111 is further adapted to retrieve the simultaneously or consecutively captured images and analyse said image data sets to predict the presence of cutaneous and subcutaneous abnormalities based on the aggregated imaging data.

[0045] We will now describe the modular multimodal imaging device 10 in more detail. The scanning modules 121 of the modular multimodal imaging device are selected according to four imaging principles: reflection based imaging, transmission based imaging, emission based imaging, and excitation based imaging. These principles and corresponding modules are described below.

[0046] Reflection based imaging modules comprise systems in which energy is emitted toward a target body portion and reflected energy is detected from the same side. These include Visual Imaging (RGB, Multispectral, Hyperspectral), Infrared Reflectance Imaging, Near Infrared Spectroscopy (NIRS) in reflectance mode, Conventional Ultrasound (B Mode, Doppler), Ultrasonic Elastography in pulse echo configuration, Terahertz Reflectance Imaging, Microwave Reflectance Imaging, Diffuse Optical Reflectance Imaging, and Optical Coherence Tomography (OCT) operating in backscattering mode.

[0047] Transmission based imaging modules comprise systems in which energy is emitted from a first side of the target body portion and detected on a second side opposite the first side after propagation through tissue. These include Transillumination Imaging, Ultrasound Transmission Imaging, Acoustic Tomography, Terahertz Transmission Imaging, Microwave Transmission Imaging, and Diffuse Optical Tomography (DOT) in transmission configuration.

[0048] Emission based imaging modules comprise systems that detect energy naturally emitted from the tissue or generated internally without requiring detection of reflected energy of the same carrier. These include Thermal Imaging such as Infrared Thermography and Contact Thermography Films, Bioluminescence Imaging, Magnetic Resonance Imaging (MRI, fMRI, MRS), Magnetoencephalography (MEG),Electroencephalography (EEG) Imaging, Electrical Impedance Tomography (EIT), Magnetic Particle Imaging (MPI), Gas Emission Imaging such as Capnography Imaging, and mechanical vibration based emission sensing.

[0049] Excitation based imaging modules comprise systems in which excitation energy is delivered to the tissue and a secondary response signal generated in the tissue is detected. These include Fluorescence Imaging using excitation light and detecting emitted fluorescence, Photoacoustic Imaging (PAI) and Optoacoustic Imaging (OA) in which pulsed optical excitation generates ultrasound signals, Stimulated Emission Imaging, Optically Excited Spectroscopy, and Surface Wave Elastography (SWE) where mechanical excitation generates a measurable response used for stiffness assessment.

[0050] Thanks to the heads 12 combining several of these modules 121, by combining complementary image data from each modality, the present invention permits to obtain several different views of the tissue being examined, leading to a more accurate, reliable, and early diagnosis.

[0051] As mentioned above, thanks to the universal interface and the interchangeable head 12, the user may easily adapt the head to a particular diagnosis. Indeed, each interchangeable head 12 may comprise at least two, preferably three, even more preferably four, ideally five or more of these modules 121.

[0052] For instance, in breast cancer detection a thermal imaging module or diffuse optical imaging can capture subtle thermal variations that reflect abnormal metabolic activity while an ultrasound-based or light-based transillumination imaging module provides detailed information on the tumor’s size and density; when these images are integrated with optical imaging that reveals surface skin changes, a more comprehensive picture of the pathology emerges.

[0053] For cervix cancer, combining visual imaging with color spectroscopy and acid whitening applied to the cervix can provide deeper, more nuanced information for detecting cervical abnormalities. When the cervix is exposed to acetic acid — administered by our dedicated scanner head — abnormal tissues typically turn white dueto increased protein content and altered cell structure. By capturing high-resolution visual images during this process, the scanner can directly observe the morphological changes on the cervix. Adding color spectroscopy into the mix enables the quantification of subtle spectral differences in the reflected light, which can correlate with biochemical changes in the tissue.

[0054] In another example, for prostate cancer screening the photoacoustic module can delineate vascular patterns and oxygenation levels that differentiate malignant from benign tissue, and when combined with mechanical imaging — which assesses tissue stiffness and elasticity altered by cancerous processes — the resulting data provide both functional and structural insights.

[0055] Similarly, in the evaluation of skin lesions or melanoma, optical imaging delivers high-resolution visual details, while fluorescence imaging, possibly enhanced by targeted dyes, highlights biochemical markers specific to malignant cells.

[0056] A second aspect of the invention is therefore the modular scanning kit comprising the modular multimodal imaging system described above and the multiple detachable and interchangeable scanning heads 12.

[0057] Examples of these heads are shown in figures 2A to 2C.

[0058] Figure 2A shows a head specifically adapted for an internal organ scan such as rectum or vagina. It has a particular geometry for this application as well as specific modules 121 and module holders 122, a motion and orientation sensing system 123, sensors for environmental features 123', and additional chemical mechanical or electromagnetic enhancement features 123". Figures 2B and 2C show additional heads with their specific modules 121 and sensors 123, 123', 123" for external organ scan, with an particular opposed module in figure 2C permitting to scan two faces of an organ.

[0059] The device’s 10 modularity and interchangeable heads 12 reduce the need for multiple separate devices in a clinical setting, improving both cost-effectiveness and operational efficiency. Healthcare professionals can easily switch between diagnosticheads to tailor the imaging modality to the specific patient or condition, making it ideal for use in a variety of settings, from routine check-ups to specialized screenings for cancer, skin diseases, and other conditions.

[0060] These Interchangeable diagnostic heads 12 are therefore adapted for specific imaging applications, including but not limited to: breast cancer, prostate cancer, cervix cancer, ovarian cancer, thyroid cancer, colon and rectal cancer, pancreatic cancer, kidney cancer, esophageal cancer, stomach cancer, testicular cancer, gallbladder cancer, rectal cancer, soft tissue sarcoma, head & neck cancers(oral cancer, throat cancer, laryngeal cancer, nasopharyngeal cancer, sinus cancer), eye health checks, prostate cancer screening, and hair and scalp health analysis.

[0061] In addition to this, the device of the present invention uses related clinical information which has high correlation with the application (type of disease) as extra information for diagnosis. These information are listed below.

[0062] The modular multimodal imaging system can for example for diagnosis of breast cancer, use high-correlated clinical information including breast imaging findings (mammography, ultrasound, MRI), histopathological analysis from biopsies, hormone receptor status (ER, PR, HER2), genetic markers (BRCA1, BRCA2), and patient history such as family history, previous benign breast disease, and hormonal exposure (e.g., early menarche, late menopause, hormone replacement therapy), breast density and changes in tissue elasticity.

[0063] Also, prostate cancer diagnosis heavily relies on PSA (prostate-specific antigen) levels, digital rectal examination (DRE) findings, prostate biopsy results (Gleason score), multiparametric MRI (mpMRI) characteristics, and family history of prostate cancer. Other important factors include urinary symptoms, testosterone levels, and molecular markers such as PCA3 and TMPRSS2-ERG fusion gene.

[0064] For cervix cancer, key clinical information includes HPV infection status (especially high-risk strains like HPV 16 and 18), Pap smear cytology results,colposcopy findings, histopathological grading of cervical intraepithelial neoplasia (CIN), and immunohistochemical markers like p16 and Ki-67.

[0065] In addition risk factors such as smoking, immune suppression (e.g., HIV infection), and long-term oral contraceptive use are also relevant.

[0066] On the other hand, symptoms like abdominal bloating, early satiety, and pelvic pain should also be considered, along with imaging from CT, MRI, and PET scans for staging.

[0067] For thyroid cancer one observes thyroid nodule characteristics on ultrasound (size, calcifications, vascularity, echogenicity), fine-needle aspiration biopsy (Bethesda classification), serum TSH and thyroglobulin levels, molecular testing for BRAF, RET / PTC, and RAS mutations, and family history of thyroid cancer or genetic syndromes (e.g., MEN2) are essential factors.

[0068] Also, Rapid nodule growth and vocal cord dysfunction should also raise suspicion.

[0069] Colon and Rectal Cancer diagnosis relies on colonoscopy findings (polyps, mucosal lesions), biopsy histopathology (adenocarcinoma grading), fecal occult blood test (FOBT) or fecal immunochemical test (FIT) results, serum CEA levels, and genetic predisposition (Lynch syndrome, APC mutations in FAP).

[0070] Other factors include bowel habit changes, unexplained weight loss, and inflammatory markers in stool (cal protectin).

[0071] For pancreatic cancer, key diagnostic indicators include CA 19-9 and CEA tumor markers, pancreatic imaging findings (CT, MRI, endoscopic ultrasound with biopsy), presence of new-onset diabetes, jaundice due to bile duct obstruction, and genetic mutations (KRAS, CDKN2A, TP53, BRCA2).

[0072] Unintentional weight loss, persistent epigastric pain, and steatorrhea are also strong clinical indicators.For Kidney Cancer, High-correlated clinical information includes renal mass characteristics on CT / MRI, biopsy histology (clear cell, papillary, chromophobe carcinoma), hematuria, flank pain, erythrocytosis or anemia, and paraneoplastic syndromes. Risk factors like smoking, hypertension, obesity, and genetic mutations (VHL in clear cell RCC) should be considered.

[0073] Regarding Esophageal Cancer, key clinical indicators include endoscopic findings (Barrett’s esophagus, strictures, masses), biopsy histopathology (adenocarcinoma vs. squamous cell carcinoma), and risk factors like chronic GERD, smoking, alcohol use, and achalasia. Dysphagia progression, unexplained weight loss, and hoarseness are also critical symptoms.

[0074] As per Stomach Cancer, high-correlated clinical information includes gastric endoscopy and biopsy results (intestinal vs. diffuse type adenocarcinoma), presence of Helicobacter pylori infection, serum pepsinogen levels (atrophic gastritis marker), and genetic factors (CDH1 mutations in hereditary diffuse gastric cancer). Symptoms like early satiety, anemia from occult bleeding, and persistent epigastric pain are also significant.

[0075] For testicular cancer, ultrasound findings (hypoechoic testicular mass, calcifications), tumor markers (AFP, beta-hCG, LDH), histopathology (seminoma vs. non-seminoma subtypes), and risk factors like cryptorchidism, family history, and Klinefelter syndrome are essential. Testicular self-examination findings, scrotal swelling, and gynecomastia (hormonal effects) are additional clinical considerations.

[0076] Regarding gallbladder cancer, key diagnostic factors include gallbladder imaging (ultrasound, MRI / MRCP, CT), presence of gallstones or porcelain gallbladder, CA 19-9 and CEA tumor markers, and biopsy findings confirming adenocarcinoma. Risk factors such as chronic cholecystitis, obesity, and primary sclerosing cholangitis are relevant.

[0077] As per rectal cancer, colonoscopy findings (tumors, polyps), biopsy histopathology, MRI for local staging, CEA levels, genetic predisposition (Lynchsyndrome, FAP), and stool-based DNA tests (CoIoguard) are important diagnostic elements. Bowel habit changes, rectal bleeding, and tenesmus should also be evaluated.

[0078] Regarding soft tissue sarcoma, diagnosis depends on MR I and CT scan characteristics, biopsy histopathology (liposarcoma, leiomyosarcoma, synovial sarcoma, etc.), genetic markers (translocations like t(X;18) in synovial sarcoma), and risk factors like previous radiation therapy.

[0079] Tumor size, depth, and location also influence prognosis.

[0080] For head & neck cancers (oral, throat, laryngeal, nasopharyngeal, sinus) clinical indicators include imaging findings (CT, MRI, PET scans), biopsy results confirming squamous cell carcinoma, HPV status (especially in oropharyngeal cancer), and risk factors such as smoking, alcohol use, Epstein-Barr virus (nasopharyngeal cancer), and occupational exposures. Hoarseness, persistent ulcers, difficulty swallowing, and nasal obstruction are key symptoms.

[0081] For eye diseases, high-correlated information includes retinal imaging (fundus photography, optical coherence tomography), intraocular pressure (glaucoma screening), slit-lamp examination findings, visual field testing, and biomarkers for age-related macular degeneration and diabetic retinopathy.

[0082] For prostate cancer screening, high-correlated information includes PSA levels, digital rectal examination (DRE), prostate biopsy histopathology (Gleason score), multiparametric MRI (mpMRI) findings, and genetic risk factors like BRCA2 mutations.

[0083] For hair and scalp health analysis, key clinical factors include trichoscopy findings (hair shaft abnormalities, miniaturization), blood tests for hormonal imbalances (DHT, thyroid hormones, ferritin), biopsy findings in scarring alopecia cases, and patient history including nutritional deficiencies, stress levels, and medication side effects.The device 10 further comprises a memory 116 embedded or via cloud service adapted to store the image data sets captured over multiple scanning sessions. Thanks to this the processing unit 111 can process and compare multiple images of a same modality captures along different temporality stored in the memory 116 and generate a diagnosis message based on the evolution of a zone of interest in said captured image but it can also, on the contrary, process and compare multiple images of different modalities captured simultaneously or immediately consecutively and generate a diagnosis message based on the combination of these images of a zone of interest.

[0084] In addition, the device 10 may comprise a screen 115 where the processing unit 111 can display said diagnosis and it can further comprise extra sensors which calculate environmental features taken from the group comprising temperature, humidity and light intensity, and use it for calibration of the imaging modules. It can also comprises an accelerometer-based system to determine the device's spatial orientation timer.

[0085] Another aspect of the invention is the modular scanning method using the modular scanning kit.

[0086] In a preferred embodiment, the modular multimodal imaging system further comprises additional chemical, mechanical, or electromagnetic features designed to highlight or enhance the visibility of abnormalities, both on the surface and at depth, thereby improving imaging quality and overall system performance. For example, a small tube can be placed beside the camera for cervical cancer detection, allowing the system to spray acid on the cervix surface, causing cancerous cells to change color for clearer identification. Similarly, for breast examinations, the system can employ two clamps to compress the breast, reducing its height and improving imaging accuracy for depth abnormalities. Alternatively, the system can apply gel to an ultrasonic probe to optimize image clarity.

[0087] According to a preferred embodiment, this method is a computer implemented method comprising the first steps of capturing multiple simultaneous or consecutiveimages data of a target body portion with said modular scanning kit equipped with a scanning head adapted to the target body portion.

[0088] This mean that, for example, if the target body portion is the breast, the imaging head is specifically adapted with imaging modules for breast cancer and its shape is also adapted for breast. On the contrary, for a colorectal imaging process, the head has different modules as explained above and, of course, a different shape.

[0089] One the images have been captured, the second step consist in retrieving said simultaneously or consecutively captured images taken with at least two modules and analyse said image data sets to predict the presence of cutaneous and subcutaneous abnormalities based on the aggregated imaging data.

[0090] Optionally, the processing unit may uses at least one of the imaging modalities for artifact correction or bias reduction or image quality enhancement of another modality.

[0091] According to a first option, the processing unit activates a specific combination of two of more scanning and imaging modules for a predetermined cutaneous and subcutaneous scanning and imaging modalities.

[0092] According to a second option, the processing unit activates at least a first specific scanning modality of a first head and, consecutively, a second modality of a second specific scanning head and combines the two or more images for a predetermined cutaneous and subcutaneous scanning and imaging diagnostic.

[0093] While the embodiments have been described in conjunction with a number of embodiments, it is evident that many alternatives, modifications and variations would be or are apparent to those of ordinary skill in the applicable arts. Accordingly, this disclosure is intended to embrace all such alternatives, modifications, equivalents and variations that are within the scope of this disclosure. This for example particularly the case regarding the different apparatuses which can be used.

Claims

CLAIMS1. A modular multimodal imaging system for scanning and imaging the anatomical regions of interest, including cutaneous, subcutaneous, or superficial structures of internal or external organs in a patient, comprising:a modular multimodal imaging device (10) including an interchangeable scanning head (12) specifically presenting a particular arrangement of at least two imaging modules (121) each supporting a distinct imaging modality, and a device body (11), wherein the scanning head (12) is designed to perform predetermined scanning modalities for detecting presence of abnormalities in cutaneous, subcutaneous, or superficial tissues of internal or external organs,wherein said at least two imaging modules (121) comprise imaging modules implementing at least two different imaging principles selected from:(i) a reflection-based imaging module configured to emit energy toward a target body portion and detect reflected energy from the same side of the target body portion,(ii) a transmission-based imaging module comprising an emitting submodule configured to be positioned on a first side of the target body portion and a receiving submodule configured to be positioned on a second side opposite the first side to detect energy transmitted through the target body portion, wherein the scanning head (12) is configured to maintain said emitting submodule and receiving submodule on opposite sides during acquisition,(iii) an emission-based imaging module configured to detect energy emitted from the target body portion,(iv) an excitation-based imaging module configured to emit an excitation energy toward the target body portion and to detect, with a corresponding receiving submodule, a response signal generated in the target body portion in response to said excitation energy,wherein at least one of said at least two imaging modules (121) is the transmission based imaging module, a controlling unit (112) adapted to control said at least two imaging modules (121), anda processing unit (111) adapted to command said controlling unit (112) to activate or combine at least two imaging modules (121) simultaneously or consecutively to capture at least two simultaneous or consecutive images data sets,characterized in that said processing unit (111) is further adapted to retrieve the simultaneously or consecutively captured image data sets, co register a image data set from one imaging principle with at least one other image data set acquired using a different imaging principle, and analyze aggregated imaging data to predict the presence of abnormalities in cutaneous, subcutaneous, or superficial tissues of internal or external organs.

2. Modular multimodal imaging system according to claim 1, characterized in that said at least two scanning modules (121) implement at least two different imaging principles selected from reflection-based imaging, transmission based imaging, emission-based imaging, and excitation-based imaging, and wherein the imaging modules are selected from the following groups:(i) reflection based imaging modules, comprising an optical reflectance imaging module, an infrared based reflectance imaging module, an ultrasound pulse echo imaging module, a microwave reflectance imaging module, a terahertz reflectance imaging module, and an electromagnetic reflectance imaging module, elastography,(ii) transmission based imaging modules, comprising a transillumination imaging module, an ultrasound transmission imaging module, an acoustic tomography module, a microwave transmission imaging module, and a terahertz transmission imaging module,(iii) emission based imaging modules, comprising a thermal imaging module, a contact thermography film module, a fluorescence imaging module, a photoacousticimaging module, a magnetic resonance imaging module, a gas emission imaging module, and a bioluminescence imaging module,(iv) excitation based imaging modules, comprising an excitation fluorescence imaging module, a stimulated emission imaging module, and an optically excited spectroscopy imaging module.

3. Modular multimodal imaging system according to claim 1 or 2, characterized in that said processing unit (111) is embedded in a remote computer system different from the modular multimodal imaging system device (10), and wherein the modular multimodal imaging system device (10) is configured to transmit to the remote computer system at least two image data sets acquired using different imaging principles together with head specific calibration data, and wherein the remote computer system is configured to co register said at least two image data sets and output aggregated imaging data for display on the modular multimodal imaging system device (10).

4. Modular multimodal imaging system according to any one of claims 1 to 3, characterized in that it further comprises a memory (116) embedded in the device or via cloud service and adapted to store the image data sets captured over multiple scanning sessions wherein the processing unit (111) is configured to perform pseudonymization of patient identifiers on the device body (11) before storage or transmission and to encrypt the stored and transmitted image data sets, and wherein the processing unit (111) is further configured to align a later scanning session to an earlier scanning session using at least one of anatomical landmarks, fiducial markers associated with the scanning head (12), and a head pose estimate, to enable longitudinal comparison of aggregated imaging data.

5. Modular multimodal imaging system according to claim 4, characterized in that said processing unit (111) is adapted to process and compare aggregated imaging data derived from multiple scanning sessions stored in the memory (116) , wherein the multiple scanning sessions comprise at least two image data sets acquired using different imaging principles, and to generate a diagnosis message by quantifying achange over time of at least one abnormality metric within a zone of interest defined in a co registered spatial reference frame.

6. Modular multimodal imaging system according to claim 4, characterized in that said processing unit (111) is adapted to process and compare multiple image data sets of different modalities captured along a similar temporality within a same scanning session or within a predefined time window, stored in the memory (116) and generate a diagnosis message based on the evolution of a zone of interest in said captured image sets, after co registration of said different modalities to a common spatial reference frame, and based on aggregated imaging data.

7. Modular multimodal imaging system according to claim 5 or 6, characterized in that said processing unit (111 ) is adapted to display said diagnosis together with a co registered multimodal overlay or fused abnormality map on a display unit (115).

8. A modular multimodal imaging system according to any one of claims 1 to 7, characterized in that it further comprises an additional sensor configured to measure environmental parameters selected from the group comprising temperature, humidity, light intensity, and other relevant ambient conditions, wherein the measured data is used for calibration of the imaging modules by normalizing at least one acquisition parameter or background signal, rejecting at least one image frame when an environmental parameter exceeds a threshold, and storing the measured data with the image data sets for longitudinal comparison.

9. Modular multimodal imaging system according to any one of claims 1 to 8, characterized in that it further comprises a motion and orientation sensing system, including but not limited to an accelerometer, for determining the spatial positioning, movement, and orientation of the device wherein the processing unit (111) is configured to perform motion gating by discarding or down weighting image frames captured when motion exceeds a threshold, and to use a pose estimate derived from the motion and orientation sensing system to improve co registration between image data sets acquired using different imaging modalities or imaging principles.

10. Modular multimodal imaging system according to any one of claims 1 to 9, characterized in that said processing unit (111) can apply Al-driven computational models, including deep learning-based anomaly detection, feature extraction, and multimodal fusion, to process and analyze image data sets, enhancing diagnostic accuracy, reducing artifacts, and improving clinical decision-making, wherein the Al driven computational models take as input at least two image data sets acquired using different imaging principles and co registered to a common spatial reference frame, the at least two image data sets comprising at least one transmission based image data set and at least one of a reflection based image data set or an emission based image data set, and wherein said multimodal fusion comprises feature level fusion by combining intermediate representations extracted from the at least two co registered image data sets, and wherein the processing unit (111) is configured to use at least one of the image data sets to perform artifact correction or calibration of another image data set prior to said feature level fusion, and to output at least one of an abnormality score map and an uncertainty metric.

11. Modular multimodal imaging system according to any one of claims 1 to 10, characterized in that it further comprises a contrast enhancement subsystem comprising a chemical applicator integrated in the scanning head (12) and configured to deliver a metered quantity of an agent to a target body portion, and wherein said processing unit (111) is configured to acquire at least one baseline image data set before delivery and at least one post delivery image data set after delivery and to compute a differential map between the baseline and post delivery image data sets as part of the aggregated imaging data, and wherein the system further comprises at least one additional enhancement feature selected from the group comprising: a mechanical compression system configured to stabilize tissue and set or measure tissue thickness for transmission based acquisition, a thermal regulation module for temperature based noise reduction, an automated gel application system for optimizing acoustic imaging, and different light spectrum for better visualization.

12. Modular multimodal imaging system according to any one of claims 1 to 11, wherein the system is configured to mitigate and or correct photon scattering for increasing subsurface visibility by applying one or more techniques comprising:(i) time resolved acquisition using pulsed near infrared illumination and time gated detection or temporal weighting to preferentially retain earlier arriving photons relative to later arriving photons,(ii) angular selectivity using at least one of collimated illumination optics, a detection side collimator, a telecentric detection configuration, spatial filtering, or an adjustable aperture configured to limit numerical aperture and reduce wide angle scattered light,(iii) spectral selectivity using at least one near infrared wavelength band and at least one wavelength matched optical filter to suppress out of band light and reduce scattering effects,(iv) polarization selectivity using polarized illumination and an analyzing polarizer on the detection path in a parallel and or crossed configuration to reduce contributions from depolarized multiply scattered photons,(v) spatial frequency selectivity using structured illumination and demodulation to suppress diffuse background, and(vi) computational scatter correction using head specific calibration data (119) and at least one of a light transport model, a calibrated phantom based correction, regularized inverse reconstruction, deconvolution, or multi condition fusion across at least two acquisition conditions selected from wavelength, polarization state, time gating, illumination pattern, and detector numerical aperture.

13. Modular scanning kit comprising the modular multimodal imaging system (10) according to any one of claims 1 to 12 and multiple detachable and interchangeable scanning heads (12a, 12b) each configured for specific anatomicalregions, wherein each scanning head (12a, 12b) is releasably couplable to the device body (11) via the interface (113), and wherein each scanning head (12a, 12b) comprises at least two imaging modules (121) implementing at least two different imaging principles as defined in claim 2, and further comprises a head identifier (118) and head specific calibration data (119) readable by the processing unit (111), the kit being characterized in that the multiple scanning heads (12a, 12b) comprise at least:a first scanning head (12a) for external organ scanning, the first scanning head (12a) comprising a transmission based imaging module including a light emitting submodule (122) configured to be positioned on a first side of a target body portion and a light receiving submodule (123) configured to be positioned on a second side opposite the first side, the first scanning head (12a) further comprising an opposed module arrangement (124) adapted to hold said submodules (122, 123) on opposite sides during acquisition, and a second scanning head (12b) for an accessible internal body cavity, the second scanning head (12b) comprising a distal tip geometry adapted for insertion into said cavity and comprising at least one of a reflection based imaging module and an emission based imaging module, and a sterile barrier or disposable cover (125), wherein the processing unit (111) is configured to load the head specific calibration data (119) based on the head identifier (118) and to co register image data sets acquired with the attached scanning head (12a, 12b) for longitudinal comparison across scanning sessions.

14. Use of a modular scanning kit according to claims 13 for specific medical applications, including oncology, dermatology, ophthalmology, and other specialized health assessments, wherein the scanning heads are selected from the group comprising those designed for detecting breast abnormalities for breast cancer detection, prostate cancer, cervix cancer, ovarian cancer, thyroid cancer, colon and rectal cancer, pancreatic cancer, kidney cancer, esophageal cancer, stomach cancer, testicular cancer, gallbladder cancer, rectal cancer, soft tissue sarcoma, head & neck cancers(oral cancer, throat cancer, laryngeal cancer, nasopharyngeal cancer, sinus cancer), eye health checks, prostate cancer screening, and hair and scalp health analysis.

15. Modular scanning method using the modular scanning kit according to claim 14, comprising the steps of receiving multiple simultaneous or consecutive images data of a target body portion with said modular scanning kit equipped with a scanning head adapted to the target body portion, retrieving said simultaneously or consecutively captured image data sets and processing said image data sets to generate aggregated imaging data and output at least one of a fused image, a feature map, a score map, or an uncertainty map.

16. Modular scanning method according to claim 15, characterized in that said processing unit (111) uses at least one imaging modality for artifact correction or bias reduction or image quality enhancement of another modality.

17. Modular scanning method according to claim 15 or 16, characterized in that said processing unit (111) activates a specific combination of two of more scanning and imaging modules to perform predetermined imaging modalities for cutaneous, subcutaneous, or other target body portions, wherein the processing unit (111) co registers the corresponding image data sets and combines them to generate the aggregated imaging data.

18. Modular scanning method according to claim 16, characterized in that said processing unit (111) activates at least a first specific scanning modality of a first head and, consecutively, a second modality of a second specific scanning head and combines the two or more images to generate aggregated imaging data.

19. Modular scanning method according to any one of claims 15 to 18, characterized in that said processing unit uses related acquisition metadata as extra information to adjust processing parameters, the related acquisition metadata comprising at least one of patient positioning information, head identifier, acquisition settings, or environmental sensor measurements.

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