# US 12,213,733 B2 · System and method for detecting physical characteristics of a multilayered tissue of a subject > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,213,733 B2 - Document ID: US12213733B2 - Status: Granted - Kind: B2 - Application number: 17/921,438 - Filed: 2021-04-25 - Published: 2023-05-25 - Granted: 2025-02-04 - Earliest claimed: 2020-04-27 - Assignees: Adom, Advanced Optical Technologies Ltd. - Applicants: Adom, Advanced Optical Technologies Ltd. - Inventors: Yoel Cohen; Ra'anan Gefen; Yoel Arieli; Lee Barnea Nehoshtan; Naor Deri - Web page: https://patentgrep.com/patent/US12213733B2 ## CPC - A61B 3/101: {for examining the tear film} - A61B 3/0025: {characterised by electronic signal processing, e.g. eye models} - A61B 3/0083: {provided with means for patient positioning} - A61B 3/0091: {Fixation targets for viewing direction} - A61B 3/10: Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions - A61B 3/152: {for aligning} - A61B 5/0066: {Optical coherence imaging} - A61B 5/1075: {for measuring dimensions by non-invasive methods, e.g. for determining thickness of tissue layer (A61B8/0858 takes precedence)} - A61B 5/0075: {by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy (A61B5/0071 takes precedence)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Systems and methods for detecting physical characteristics of a multilayered tissue of a subject, such as a tear film including analyzing received detector-output indicative of optical properties of light reflected or deflected from the respective multilayered tissue, to determine spectral properties of the multilayered tissue; and determining physical characteristics of the multilayered tissue by using multiple spectral models of the of the multilayered tissue, each model being associated with spectral properties indicative of different tissue characteristics, wherein physical characteristics of the multilayered tissue are determined by hierarchal determination of a best-fit model from the multiple spectral models. ## Claims ### Claim 1 A system for detecting physical characteristics of a multilayered tissue of a subject, the system comprising: an optical subsystem comprising at least: a broadband light source configured and positioned to directly or indirectly illuminate the multilayered tissue; and at least one optical detector, configured and positioned to optically detect one or more optical properties of the multilayered tissue; and a processing module operatively associated with the optical subsystem, the processing module being configured to: receive detector output from the at least one optical detector; determine spectral properties of the multilayered tissue by processing the received detector output; and determine physical characteristics of the multilayered tissue by using multiple spectral models of the multilayered tissue comprising at least: a first model assuming a normal condition of the multilayered tissue and one or more additional models, assuming abnormal conditions of the multilayered tissue, each model being associated with different spectral properties, wherein physical characteristics of the multilayered tissue are determined by hierarchal determination of a best-fit model from the multiple spectral models, based on determination of best-fit of the multilayered tissue to one of the spectral model, wherein the processing module is configured to determine the physical characteristics of the multilayered tissue by comparing spectral properties of a reflected light to spectral properties of the first model and of the one or more additional models within at least one predefined wavelengths range in which spectral properties of the reflected light is distinctively different for different conditions of the multilayered tissue, and wherein the physical characteristics of the multilayered tissue comprise one or more of: thickness of at least one layer of the multilayered tissue; thickness of at least one area of at least one layer of the multilayered tissue; foreign bodies types, dimensions, coverage, material, concentration, periodical level, and/or thickness; accumulated structures' configuration, dimensions and/or periodicity level; layers arrangement; differences in thicknesses of areas of a layer or a sub layer of the multilayered tissue. ### Claim 2 (depends on 1) The system of claim 1, wherein the spectral properties comprise a behavior of an intensity of the reflected light in respect to a wavelength of the reflected light. ### Claim 3 (depends on 1) The system of claim 1, wherein the at least one optical detector comprises at least one of: a spectrometer, an interferometer, a color camera, a color sensor, wherein the processing module is configured to combine output of all optical detectors being used for improving determination of spectral properties of the multilayered tissue, areas and/or layers thereof. ### Claim 4 (depends on 1) The system of claim 1, wherein the at least one optical detector is configured at least for detecting light in the near infrared (NIR) and/or visible (VIS) wavelength bands. ### Claim 5 (depends on 1) The system of claim 1, being configured for detection of physical characteristics of a tear film multilayered tissue, wherein the layers of the tear film comprise at least: a lipid layer, aqueous layer, mucus layer and a rough epithelium layer, wherein the first model of the tear film is associated with spectral properties of a normal tear film condition in which the lipid layer is continuous and within a predefined thickness range and one or more additional models represent spectral properties of a tear film of abnormal conditions in which the lipid layer is disrupted by at least one intermediate layer. ### Claim 6 (depends on 5) The system of claim 5, wherein models representing spectral characteristics of the lipid layer are indicative of one or more of: I. different thicknesses of the lipid layer; II. different thicknesses of the one or more inner sublayers in the lipid layer; III. thicknesses of upper and lower lipid layers and thickness of the at least one intermediate layer, in cases in which the lipid layer is separated by an intermediate layer; IV. dimensions, size, arrangement and/or material types of one or more foreign bodies and/or of one or more accumulated droplets. ### Claim 7 (depends on 5) The system of claim 5, wherein each of the spectral models represents behavior of intensity of light reflected from a cornea of the subject in respect to wavelength of the reflected light. ### Claim 8 (depends on 5) The system of claim 5, wherein the optical subsystem is further configured to direct at least a portion of light emanating from the light source towards a cornea of an eye of the respective subject for measuring optical characteristics of the subject's tear film tissue and to direct at least a portion of light reflected and/or deflected from the subject's cornea towards each of the at least one optical detector. ### Claim 9 (depends on 8) The system of claim 8, wherein the optical subsystem is further configured to: assist in achieving optimal relative optical position of a point or area of the surface of the cornea of the subject in respect to at least one optical axis of the optical subsystem by using imaging means of the optical subsystem, to form at least one image over the subject's cornea surface; and/or directing subject's gaze. ### Claim 10 (depends on 9) The system of claim 9, wherein the optical subsystem comprises one or more grid elements for forming a grid image over the subject's cornea surface, for achieving desired relative position between the subject's cornea and the at least one optical axis of the optical subsystem. ### Claim 11 (depends on 9) The system of claim 9, wherein the optical subsystem further comprises a reticle and/or a head support, for assisting a subject in directing his/her gaze for preventing or reducing the subject from moving his/her head and/or from shifting his/her gaze from a single gazing axis. ### Claim 12 A method for detecting physical characteristics of a multilayered tissue of a subject, the method comprising at least the steps of: receiving detector output from at least one optical detector, the detector output being indicative of optical properties of light reflected or deflected from the respective multilayered tissue; analyzing the received detector-output to determine spectral properties of the multilayered tissue; and determining physical characteristics of the multilayered tissue by using multiple spectral models of the of the multilayered tissue comprising at least: a first model assuming a normal condition of the multilayered tissue and one or more additional models, assuming abnormal conditions of the multilayered tissue, each model being associated with different spectral properties of the multilayered tissue, wherein physical characteristics of the multilayered tissue are determined by hierarchal determination of a best-fit model from the multiple spectral models, based on determination of best-fit of the multilayered tissue to one of the spectral models, wherein the determining of the physical characteristics of the multilayered tissue is done by comparing spectral properties of a reflected light to spectral properties of the first model and of the one or more additional models within at least one predefined wavelengths range in which spectral properties of the reflected light is distinctively different for different conditions of the multilayered tissue, and wherein the physical characteristics of the multilayered tissue comprise one or more of: thickness of at least one layer of the multilayered tissue; thickness of at least one area of at least one layer of the multilayered tissue; foreign bodies dimensions, coverage, material, concentration, periodical level, and/or thickness; accumulated structures' configuration, dimensions and/or periodicity level; layers arrangement; differences in thicknesses of areas of a layer of the multilayered tissue. ### Claim 13 (depends on 12) The method of claim 12, wherein the spectral properties comprise a behavior of an intensity of the reflected light in respect to a wavelength of the reflected light. ### Claim 14 (depends on 12) The method of claim 12, wherein the at least one optical detector comprises at least one of: a spectrometer, an interferometer, a color camera, a color sensor, wherein the analysis of the detector output is done by combining output of all optical detectors being used for improving determination of spectral properties of the multilayered tissue, areas and/or layers thereof. ### Claim 15 (depends on 12) The method of claim 12, wherein the multilayered tissue comprises a tear film, wherein the layers of the tear film comprise at least: a lipid layer, aqueous layer, mucus layer and a rough epithelium layer, wherein the models of the lipid layer are associated with one of two optional lipid layer states: a first lipid layer state in which the lipid layer is continuous and a second lipid layer state having one or more inner sublayers withing the lipid layer. ### Claim 16 (depends on 15) The method of claim 15, wherein models representing spectral characteristics of the lipid layer are indicative of one or more of: i. different thicknesses of the lipid layer; ii. different thicknesses of the one or more inner sublayers in the lipid layer; iii. thicknesses of upper and lower lipid layers and thickness of intermediate aqueous layer, in cases in which the lipid layer is separated by an intermediate aqueous layer; iv. dimensions, size, arrangement and/or material types of one or more foreign bodies and/or of one or more accumulated droplets.