WO2024102878A1 - Automated medical observation and diagnostic platform - Google Patents

Automated medical observation and diagnostic platform Download PDF

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Publication number
WO2024102878A1
WO2024102878A1 PCT/US2023/079183 US2023079183W WO2024102878A1 WO 2024102878 A1 WO2024102878 A1 WO 2024102878A1 US 2023079183 W US2023079183 W US 2023079183W WO 2024102878 A1 WO2024102878 A1 WO 2024102878A1
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WO
WIPO (PCT)
Prior art keywords
head unit
patient
light source
vertical lift
lift stage
Prior art date
Application number
PCT/US2023/079183
Other languages
French (fr)
Inventor
Daniel O'connell
Moe TUN
Riley G. AUMILLER
Original Assignee
Hnu Photonics, Llc
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Publication date
Application filed by Hnu Photonics, Llc filed Critical Hnu Photonics, Llc
Publication of WO2024102878A1 publication Critical patent/WO2024102878A1/en

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Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0062—Arrangements for scanning
    • A61B5/0064—Body surface scanning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A61B5/015—By temperature mapping of body part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A61B5/02055—Simultaneously evaluating both cardiovascular condition and temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/0507—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves  using microwaves or terahertz waves
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H15/00—ICT specially adapted for medical reports, e.g. generation or transmission thereof
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H30/00—ICT specially adapted for the handling or processing of medical images
    • G16H30/20—ICT specially adapted for the handling or processing of medical images for handling medical images, e.g. DICOM, HL7 or PACS
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

Definitions

  • Described herein is a fully-automated and robotic device which eliminates most routine nursing activities, leaving nurses with as much as 25% more time to concentrate on patient assessment and interaction.
  • Most medical interactions with patients begin in a clinical environment with a variety of individual physical assessments done manually by highly-trained medical staff and interpreted with some level of subjectivity.
  • the device described herein represents an entirely new approach to diagnostic medicine by incorporating multiple interactive physical observations into one integrated assessment of the entire patient, thereby eliminating the inherent observational bias from multiple individual assessments.
  • the device's robotic aligning and data capturing system is powered by research-based algorithms which ensure that the most relevant data is captured.
  • the device described herein performs comprehensive, low-cost diagnostic medical assessments. It is accurate, fast, fully-automated, environmentally-friendly, adaptable, and can be administered in any location, at any time, without direct interaction with trained medical staff. This device can measure multiple patient biomarkers simultaneously with autonomous and/or remote operations, removing the necessity of manual measurements, interactions, and dangerous exposures (viral or pathogenic) to medical professionals.
  • the remote-controlled and -operated device described herein automatically detects a person approaching, automatically adjusts and calibrates to accommodate the individual, automatically collects data, and automatically generates an encrypted report of its findings.
  • the device incorporates: multi-targeting LIDAR; two visible cameras (auto-focusing and 3D imaging); a thermal camera; a hyper-spectral imaging camera; LED lighting for optimal image capture; audio speakers and microphone; a dual-axis scanning gimbal; a vertical lift stage; and a tilt sensor.
  • the device's robotic aligning and data capturing system may be powered by researchbased algorithms which ensure that the most relevant data is captured. Research-based algorithms generate more accurate results than unaided human observations or those projected by simple machine learning.
  • the device described herein incorporates the "CHKr” system, an advanced data encryption technology capable of storing 7,000% or more data than a two dimensional QR codes.
  • This system generates fully-encrypted individual results, securely stored in the cloud and only accessible to CHKr-enabled medical professionals. These private medical records complement and are fully compatible with systems used by telehealth practitioners.
  • FIG. 1 shows two views of the head unit of the device described herein.
  • Fig. 2 shows how one example of the configuration of the sensors deployed in the head unit.
  • Fig. 3 shows a device which includes a head unit, a stand, three light sources, and legs with wheels which enable the device to be rolled along the floor.
  • Fig.4 shows a device mounted on a platform, and the relative position of a patient undergoing examination
  • Fig. 5 shows a device mounted on a platform, and an optional wheeled base on which the device may be mounted, which may include one or more motors.
  • the device described herein requires no costly nurse or clinician to operate, is available on demand on a 24/7 basis, and an optional battery pack enables utilization in remote locations or post-disaster areas where reliable power supply is unavailable.
  • the device described herein may be equipped with a patient-facing touchscreen or touchless visible display to responds to voice instructions and commands to autonomously give directions and capture patient health data without the need for a medical professional or technical operator being physically present.
  • the device described herein robotically questions patients based on observed and interpreted data, rapidly updates patients' electronic medical records, and serves as the primary patient interface during or prior to telehealth sessions.
  • the device described herein may interactively and simultaneously fuse data obtained from LIDAR, hyperspectral, thermal, and visual imaging sensors of patient's eyes, heart, lungs, kidneys, liver, etc., thereby uniquely and accurately assessing the entire state of health as opposed to the current practice of assessing individual components/symptoms and estimating/diagnosing their combined effects.
  • the device described herein focuses on the patient's face, automatically adjusts for patient's height and distance from the device, and provides controlled light illumination, which eliminates ambient lighting variations, prior to data capture and analysis, resulting in a consistent, repeatable, and accurate set of measurements.
  • the device described herein improves diagnostic accuracy a) by combining internally- calibrated multiple-light spectral observations with visual images to correlate molecular data to a specific location; b) by collecting temperature readings at multiple locations; and c) by analyzing patient blood characteristics in the eyes, the only place on the human body where blood vessels are directly visible.
  • the device described herein has zero body contact, takes zero physical samples, and uses zero chemical reagents.
  • the device described herein produces zero biohazard waste.
  • the device described herein SENSE operates at a distance of a few inches to 3 feet, (with typical distance of 2 feet from the test subject to avoid contact), doesn't require any physical interactions with the patient, and is therefore completely non-invasive.
  • the device described herein can be configured/calibrated/trained to detect emerging diseases, such as the seasonal flu. Via software updates, the device described herein can dynamically adjust to emerging health crises in real-time as multimodal data is gathered across the globe. Indeed, as new pathogens are identified, all devices around the globe can be simultaneously updated to recognize that pathogen to limit and/or prevent its global spread. [026] The device described herein produces an affordable rapid health screening result in 20 seconds or less, surpassing the state of the art by an order of magnitude, delivers an audio and encrypted printed diagnosis to the patient or medical professional, and is ideal for high- throughput health scanning in crowded locations.
  • the device described herein is a pioneering breakthrough that will revolutionize patient in-processing for both routine as well as emergency visits to the Doctor's office, hospital, medical clinic.
  • the device described herein can also be used for health screening in the home or any accessible location such as workplace, school or even public venue where a device can be located.
  • the device described herein can also be used as an automated multi-variable biometric measurement platform.
  • the unique combination of sensors used for health screening can also capture multiple biological measurements or physical characteristics of individuals such as fingerprints, facial details for automated recognition, iris and even retinal images using the multiple displaced imaging sensors with video, spectral, zoom, focus, and aperture control.
  • the device described herein incorporates a comprehensive suite of measurement sensors and devices that are mounted to a common fixture (or head unit) and externally mounted sensors that are connected electronically or wirelessly that integrate into a central control computer unit and interface to a secure datalogging unit which catalogs measured data and appends results into general health reports, dashboard reports or graphs or secure patient records.
  • the device described herein platform consists of a unique suite of internal and or externally integrated sensors that include but are not limited to a calibratable pressure sensor for measuring weight as well as performing subject strength tests, pulse measuring device, blood oxygen level, blood pressure, lung capacity, etc. Each sensor is mounted in a unique configuration within the device head or connected to the device head through a wire or wireless data communication link creating an automated and integrated health status report electronically.
  • Wireless interfaces may include, but are not limited to, RF, Magnetic, Optical transceivers, Bluetooth, WiFi or any RF or Optical frequencies and architectures used to transmit measured data from a sensor to a central computer and datalogging unit.
  • the sensor head 3 shown in Fig. 1 may be fashioned to resemble a recognizable and trusted robotic personality which can take any shape or form.
  • the device may include a suite of sensors including but not limited to:
  • thermal imaging sensors 1 to measure body temperature as well as other temperature data that reveal various conditions such as constricted blood flow in parts of the body, limbs or extremities or detect disease states;
  • hyper-spectral or multi-spectral imaging sensors to analyze detailed spectral properties of any part of the body including but not limited to the face, mouth, nose, ears, eyes, skin, scalp, limbs, extremities, as well as body fluid in sample holder);
  • acoustic sensors 6 for communicating with a subject providing audible cues, listening to the responses from a subject, providing hearing tests;
  • a visual display 4 for providing visual cues to a subject as well as providing vision tests
  • control computer with microprocessor to the sensor suite and overall operation and data collection and interaction with subjects and health care personnel;
  • the body of the device comprises a calibrated multi-axis scanning gimbal 7 that enables the device to be configured to scan a subject or scene in both pan and tilt, and a calibrated vertical axis elevator stage to permit adjustment to the height of a subject and measure subject height.
  • the device may be mounted to a fixed or wheeled base or to any other attachment including a wall attachment or mobile cart.
  • the device described herein is primarily a health screening platform however due to the uniquely configured multiple sensors integrated within the head unit it can also be used as an automated multi-variable biometric measurement platform.
  • the combination of sensors used for health screening can also capture multiple biological measurements or physical characteristics of individuals such as fingerprints, facial details for automated recognition, iris and even retinal images.
  • the system described herein is suitable for making general health assessments of a patient. It can be configured for disease detection and assessment, and/or for organ health and assessment.
  • the system may be configured to provide both indirect indicators as well as to perform direct diagnostics tests, including General Health Metrics; Health Assessment; Disease Diagnosis; Detection of Irregularities; and Early Detection - Diagnosis - Treatment.
  • the sensor platform described herein can measure general health parameters automatically that are typically collected during a doctor visit including but not limited to height, weight, temperature, pulse, blood oxygen levels, and to perform standard eye exams and hearing exams through an integrated sensor unit.
  • the device may be configured to perform a wide range of more in-depth diagnostics.
  • the innovative combination of visible, thermal and spectral sensors combined with high resolution and adjustable sensors have the ability to provide inframe digital diagnostics, for example through topographical measurements assessments can be made of internal health including organs, blood, etc.
  • the device may also be configured to detect and assess disease in patients, including viral or bacterial infections such as hepatitis, influenza, cholera, and others.
  • the device may also be configured to assess the health of organs such as lungs, heart, liver, brain, kidneys, etc.
  • the device described herein may be configured as an integrated datalogging sensor platform.
  • the device enables health monitoring of a patient by automatically collecting measurements regarding health status or vital signs integrated into a secure central control unit with computing module and data logging module. These health status and physical attributes are measured through a suite of integrated devices and accessory devices that can measure the following metrics including, but not limited to, height, weight, body temperature, pulse, blood oxygen level, and blood pressure.
  • the device may also be configured to perform a standard eye test and hearing test.
  • This suite of measurements is provided via a combination or fusion of visible, thermal and spectral sensors, creating multiple high resolution data sets including, but not limited to high resolution visible and/or infrared imagery, spectral imagery and thermal imagery.
  • This provides the ability to inspect health parameters such as skin color and skin variations including spatial variations, color variations and thermal variations, and can additionally provide indication of diseased states and blood flow restrictions, etc.
  • the system can also measure eye color and variations including blood vessels in the eyes and other exposed veins. Detailed measurements of the pupil, iris, retina, sclera, cornea, lens, lacrimal, and blood vessels combined can provide a wealth of information regarding health conditions including kidneys, liver and heart as well as measuring direct eye health.
  • the device described herein may be configured to measure many vital health parameters without physical contact with the patient, including but not limited to: height, weight, body temperature, pulse, blood oxygen level, blood pressure, and heart rate / pulse.
  • the system may also be configured to measure advanced parameters including, but not limited to, heart irregularities and/or breath/breathing irregularities.
  • the device described herein may also be configured to perform an eye test, including but not limited to eye charts, vision depth and color tests, and ophthalmological measurements for eyewear.
  • the device described herein may also be configured to conduct a hearing test, including volume and tone limits, etc.
  • the device described herein may also be configured to conduct advanced health diagnostic measurements of multiple organ systems, including but not limited to:
  • - Lungs using high resolution hyper-spectral imaging of the mouth, tongue, throat, a number of health symptoms can be measured pertaining to asthma, infections, pneumonia, viral infections);
  • Kidneys skin and eye coloration, blood vessel analysis accessible from visible and spectral images of the eyes;
  • the device comprises a combination of sensors configured in a manner that enables a host of medical screening and recording tests to be conducted more efficiently than currently possible.
  • the device comprises one or more of the following sensors, devices or components:
  • - Hyperspectral Imaging Sensor - LED, Laser and Lidar sensors for distance measuring, waveform measuring and other light sensing parameters to measure transparency, opacity, index, discoloration;
  • - Interactive Display Screen including but not limited to a Touch Screen Display for certain configurations
  • Illumination sources including but not limited to broad spectrum or narrow band LED or Laser sources;
  • the device is configured with combination of optical cameras, which are aimed at a subject to perform a detailed eye exam which can make measurements including, but not limited to, eye shape parameters, color, curvatures, cloudiness and relative eye positions by measuring position of both eyes accurately and tracking relative eye motion.
  • Relative eye positions are measured by accurately measuring the geometric axis of each eye, providing information regarding eye misalignments such as strabismus, double vision, loss of depth perception or other eye conditions that cause blurred vision, strain, fatigue, pain, and/or motion sickness.
  • the platform may be configured to measure other eye conditions including "dry eye,” and to make ophthalmological measurements of the eye including shape for eye wear or visual aids, as well as detecting other eye conditions such as cataracts, and even glaucoma by accurately measuring the shape of each eye relative to standard measurements where such measurements can aid subsequent surgery.
  • the Med-Sense array of multiple optical imaging sensors have zoom control in order to magnify the optical view to perform as a stand-off microscope or long-distance microscope to make measurements of the retina.
  • the innovative combination of zoom lens control and multiple cameras have the ability to image the retina for measuring damage or potential detachment and when combined with light measurements are able to assess the opacity of the eye, focal length of the lens, distortion of the eye either on-axis or off-axis providing a convenient measurement for eye correction.
  • transparency and discoloration can be measured in order to determine other conditions such as cataracts, Fuchs disease, etc.

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Abstract

Described herein is a device which enables health monitoring of a patient without physical contact with the patient, by automatically collecting measurements regarding health status or vital signs integrated into a secure central control unit with computing module and data logging module. These health status and physical attributes are measured through a suite of integrated devices and accessory devices that can measure the following metrics including, but not limited to, height, weight, body temperature, pulse, blood oxygen level, and blood pressure. The device may also be configured to perform a standard eye test and hearing test.

Description

AUTOMATED MEDICAL OBSERVATION AND DIAGNOSTIC PLATFORM
BACKGROUND
[001] According to the CDC, there were an estimated 860.4 million office-based physician visits in the United States in 2018. Within the 27 OECD countries, average per capita doctor visits in 2018 ranged from 16.6 in South Korea to 2.8 in Mexico and Sweden. Globally, billions of doctor visits happen annually, each of which could advantageously be made more efficient.
[002] According to a July 20, 2022 report by CNN, there is a dire shortage of nurses across the US. The report cites a 2018 study projecting a national shortage of over half a million registered nurses by 2030 and notes that the pandemic worsened the shortage the country was already facing as "nurses abandoned a workplace where conditions have become harder to endure." [003] As licensed nurses are increasingly attracted to more lucrative temporary "travel nurse" assignments, the CNN report continues, teaching vacancies go unfilled and colleges are unable to expand their nursing programs sufficiently to meet growing demand. "Colleges and universities are turning away tens of thousands of qualified aspiring nursing students every year."
[004] Current routine medical screening has numerous inefficiencies:
• Consists of a labor-intensive panel of manually-administered tests
• Is only available in clinical environments
• Is only available during specific operating hours
• Is performed by increasingly-scarce and expensive highly-trained nurses and clinicians
• Extracts physical samples that are sent to remote labs for analysis
• Produces biohazard waste
• Involves a degree of subjectivity in creating a comprehensive patient assessment
• Cannot be configured to detect emerging diseases on a global scale
• Is not feasible for large gathering events
SUMMARY
[005] Described herein is a fully-automated and robotic device which eliminates most routine nursing activities, leaving nurses with as much as 25% more time to concentrate on patient assessment and interaction. [006] Most medical interactions with patients begin in a clinical environment with a variety of individual physical assessments done manually by highly-trained medical staff and interpreted with some level of subjectivity. The device described herein represents an entirely new approach to diagnostic medicine by incorporating multiple interactive physical observations into one integrated assessment of the entire patient, thereby eliminating the inherent observational bias from multiple individual assessments. The device's robotic aligning and data capturing system is powered by research-based algorithms which ensure that the most relevant data is captured.
[007] The device described herein performs comprehensive, low-cost diagnostic medical assessments. It is accurate, fast, fully-automated, environmentally-friendly, adaptable, and can be administered in any location, at any time, without direct interaction with trained medical staff. This device can measure multiple patient biomarkers simultaneously with autonomous and/or remote operations, removing the necessity of manual measurements, interactions, and dangerous exposures (viral or pathogenic) to medical professionals.
[008] The remote-controlled and -operated device described herein automatically detects a person approaching, automatically adjusts and calibrates to accommodate the individual, automatically collects data, and automatically generates an encrypted report of its findings. In a particular embodiment, the device incorporates: multi-targeting LIDAR; two visible cameras (auto-focusing and 3D imaging); a thermal camera; a hyper-spectral imaging camera; LED lighting for optimal image capture; audio speakers and microphone; a dual-axis scanning gimbal; a vertical lift stage; and a tilt sensor.
[009] The device's robotic aligning and data capturing system may be powered by researchbased algorithms which ensure that the most relevant data is captured. Research-based algorithms generate more accurate results than unaided human observations or those projected by simple machine learning.
[010] The device described herein incorporates the "CHKr" system, an advanced data encryption technology capable of storing 7,000% or more data than a two dimensional QR codes. This system generates fully-encrypted individual results, securely stored in the cloud and only accessible to CHKr-enabled medical professionals. These private medical records complement and are fully compatible with systems used by telehealth practitioners.
Brief Description of the Drawings
[Oil] Fig. 1 shows two views of the head unit of the device described herein.
[012] Fig. 2 shows how one example of the configuration of the sensors deployed in the head unit.
[013] Fig. 3 shows a device which includes a head unit, a stand, three light sources, and legs with wheels which enable the device to be rolled along the floor.
[014] Fig.4 shows a device mounted on a platform, and the relative position of a patient undergoing examination
[015] Fig. 5 shows a device mounted on a platform, and an optional wheeled base on which the device may be mounted, which may include one or more motors.
Detailed Description
[016] Provided herein is an automated medical observation and diagnostic platform designed to eliminate most routine nurse/patient procedures (determining height, weight, temperature, blood pressure, pulse, blood oxygen, etc.), enabling these increasingly-scarce medical professionals to spend as much as 25% more time in substantive patient interactions.
[017] The device described herein requires no costly nurse or clinician to operate, is available on demand on a 24/7 basis, and an optional battery pack enables utilization in remote locations or post-disaster areas where reliable power supply is unavailable.
[018] The device described herein may be equipped with a patient-facing touchscreen or touchless visible display to responds to voice instructions and commands to autonomously give directions and capture patient health data without the need for a medical professional or technical operator being physically present.
[019] In one embodiment, the device described herein robotically questions patients based on observed and interpreted data, rapidly updates patients' electronic medical records, and serves as the primary patient interface during or prior to telehealth sessions. [020] The device described herein may interactively and simultaneously fuse data obtained from LIDAR, hyperspectral, thermal, and visual imaging sensors of patient's eyes, heart, lungs, kidneys, liver, etc., thereby uniquely and accurately assessing the entire state of health as opposed to the current practice of assessing individual components/symptoms and estimating/diagnosing their combined effects.
[021] Completely automated and robotically-controlled, the device described herein focuses on the patient's face, automatically adjusts for patient's height and distance from the device, and provides controlled light illumination, which eliminates ambient lighting variations, prior to data capture and analysis, resulting in a consistent, repeatable, and accurate set of measurements. [022] The device described herein improves diagnostic accuracy a) by combining internally- calibrated multiple-light spectral observations with visual images to correlate molecular data to a specific location; b) by collecting temperature readings at multiple locations; and c) by analyzing patient blood characteristics in the eyes, the only place on the human body where blood vessels are directly visible.
[023] The device described herein has zero body contact, takes zero physical samples, and uses zero chemical reagents. The device described herein produces zero biohazard waste.
[024] The device described herein SENSE operates at a distance of a few inches to 3 feet, (with typical distance of 2 feet from the test subject to avoid contact), doesn't require any physical interactions with the patient, and is therefore completely non-invasive.
[025] The device described herein can be configured/calibrated/trained to detect emerging diseases, such as the seasonal flu. Via software updates, the device described herein can dynamically adjust to emerging health crises in real-time as multimodal data is gathered across the globe. Indeed, as new pathogens are identified, all devices around the globe can be simultaneously updated to recognize that pathogen to limit and/or prevent its global spread. [026] The device described herein produces an affordable rapid health screening result in 20 seconds or less, surpassing the state of the art by an order of magnitude, delivers an audio and encrypted printed diagnosis to the patient or medical professional, and is ideal for high- throughput health scanning in crowded locations. [027] The device described herein is a pioneering breakthrough that will revolutionize patient in-processing for both routine as well as emergency visits to the Doctor's office, hospital, medical clinic. The device described herein can also be used for health screening in the home or any accessible location such as workplace, school or even public venue where a device can be located. The device described herein can also be used as an automated multi-variable biometric measurement platform. The unique combination of sensors used for health screening can also capture multiple biological measurements or physical characteristics of individuals such as fingerprints, facial details for automated recognition, iris and even retinal images using the multiple displaced imaging sensors with video, spectral, zoom, focus, and aperture control.
Unique combination of sensors and measurement devices both internal and external accessory sensors
[028] The device described herein incorporates a comprehensive suite of measurement sensors and devices that are mounted to a common fixture (or head unit) and externally mounted sensors that are connected electronically or wirelessly that integrate into a central control computer unit and interface to a secure datalogging unit which catalogs measured data and appends results into general health reports, dashboard reports or graphs or secure patient records.
Integrated Secure Data Logging Sensor Platform
[029] The device described herein platform consists of a unique suite of internal and or externally integrated sensors that include but are not limited to a calibratable pressure sensor for measuring weight as well as performing subject strength tests, pulse measuring device, blood oxygen level, blood pressure, lung capacity, etc. Each sensor is mounted in a unique configuration within the device head or connected to the device head through a wire or wireless data communication link creating an automated and integrated health status report electronically. [030] Wireless interfaces may include, but are not limited to, RF, Magnetic, Optical transceivers, Bluetooth, WiFi or any RF or Optical frequencies and architectures used to transmit measured data from a sensor to a central computer and datalogging unit.
Automated General Health Data Collection System
[031] The sensor head 3, shown in Fig. 1, may be fashioned to resemble a recognizable and trusted robotic personality which can take any shape or form. The device may include a suite of sensors including but not limited to:
- thermal imaging sensors 1 to measure body temperature as well as other temperature data that reveal various conditions such as constricted blood flow in parts of the body, limbs or extremities or detect disease states;
- visible light or infrared video cameras that can capture high resolution video and still images of the subject face or specific regions of the face or body to measure pulse;
- hyper-spectral or multi-spectral imaging sensors (to analyze detailed spectral properties of any part of the body including but not limited to the face, mouth, nose, ears, eyes, skin, scalp, limbs, extremities, as well as body fluid in sample holder);
- LIDAR sensors 5;
- illumination sources 2 for spectral photo-metric measurements;
- tactile sensors, acoustic sensors 6 for communicating with a subject providing audible cues, listening to the responses from a subject, providing hearing tests;
- a visual display 4 for providing visual cues to a subject as well as providing vision tests;
- one or more micro-controllers;
- a control computer with microprocessor to the sensor suite and overall operation and data collection and interaction with subjects and health care personnel;
- a data communication hub;
- auto-focusing servo controllers;
- a zoom control to change the magnification of the object under analysis; and
- aperture control to auto adjust to lighting conditions and provide standardized lighting metrics.
[032] In one embodiment, the body of the device comprises a calibrated multi-axis scanning gimbal 7 that enables the device to be configured to scan a subject or scene in both pan and tilt, and a calibrated vertical axis elevator stage to permit adjustment to the height of a subject and measure subject height. The device may be mounted to a fixed or wheeled base or to any other attachment including a wall attachment or mobile cart.
Automated Multi-Variable Biometric scan
[033] The device described herein is primarily a health screening platform however due to the uniquely configured multiple sensors integrated within the head unit it can also be used as an automated multi-variable biometric measurement platform. The combination of sensors used for health screening can also capture multiple biological measurements or physical characteristics of individuals such as fingerprints, facial details for automated recognition, iris and even retinal images.
Diagnostic Assessment Platform
[034] The system described herein is suitable for making general health assessments of a patient. It can be configured for disease detection and assessment, and/or for organ health and assessment. The system may be configured to provide both indirect indicators as well as to perform direct diagnostics tests, including General Health Metrics; Health Assessment; Disease Diagnosis; Detection of Irregularities; and Early Detection - Diagnosis - Treatment.
[035] The sensor platform described herein can measure general health parameters automatically that are typically collected during a doctor visit including but not limited to height, weight, temperature, pulse, blood oxygen levels, and to perform standard eye exams and hearing exams through an integrated sensor unit.
[036] In addition to creating an integrated automated general health data collection and logging platform for measuring and recording general subject parameters such as height, temperature, pulse, etc. with the platform described herein, the device may be configured to perform a wide range of more in-depth diagnostics. The innovative combination of visible, thermal and spectral sensors combined with high resolution and adjustable sensors have the ability to provide inframe digital diagnostics, for example through topographical measurements assessments can be made of internal health including organs, blood, etc. The device may also be configured to detect and assess disease in patients, including viral or bacterial infections such as hepatitis, influenza, cholera, and others. The device may also be configured to assess the health of organs such as lungs, heart, liver, brain, kidneys, etc.
[037] The device described herein may be configured as an integrated datalogging sensor platform. The device enables health monitoring of a patient by automatically collecting measurements regarding health status or vital signs integrated into a secure central control unit with computing module and data logging module. These health status and physical attributes are measured through a suite of integrated devices and accessory devices that can measure the following metrics including, but not limited to, height, weight, body temperature, pulse, blood oxygen level, and blood pressure. The device may also be configured to perform a standard eye test and hearing test.
[038] This suite of measurements is provided via a combination or fusion of visible, thermal and spectral sensors, creating multiple high resolution data sets including, but not limited to high resolution visible and/or infrared imagery, spectral imagery and thermal imagery. This provides the ability to inspect health parameters such as skin color and skin variations including spatial variations, color variations and thermal variations, and can additionally provide indication of diseased states and blood flow restrictions, etc. The system can also measure eye color and variations including blood vessels in the eyes and other exposed veins. Detailed measurements of the pupil, iris, retina, sclera, cornea, lens, lacrimal, and blood vessels combined can provide a wealth of information regarding health conditions including kidneys, liver and heart as well as measuring direct eye health.
[039] The device described herein may be configured to measure many vital health parameters without physical contact with the patient, including but not limited to: height, weight, body temperature, pulse, blood oxygen level, blood pressure, and heart rate / pulse. The system may also be configured to measure advanced parameters including, but not limited to, heart irregularities and/or breath/breathing irregularities.
[040] The device described herein may also be configured to perform an eye test, including but not limited to eye charts, vision depth and color tests, and ophthalmological measurements for eyewear. The device described herein may also be configured to conduct a hearing test, including volume and tone limits, etc. [041] The device described herein may also be configured to conduct advanced health diagnostic measurements of multiple organ systems, including but not limited to:
- Eye (eye alignment, strabismus, dry eye, glaucoma, etc,);
- Heart (high-resolution, high frame-rate video sensors within the platform are capable of measuring heart rate anomalies);
- Lungs (using high resolution hyper-spectral imaging of the mouth, tongue, throat, a number of health symptoms can be measured pertaining to asthma, infections, pneumonia, viral infections);
- Kidneys (skin and eye coloration, blood vessel analysis accessible from visible and spectral images of the eyes);
- Liver (skin and eye coloration, blood vessel analysis accessible from visible and spectral images of the eyes);
- Brain (concussion, etc);
- Skin (lesions, infections such as eczema, MRSA, cancerous conditions of the skin including melanoma and pre-cancerous lesions);
- Extremities (fingers, toes, nose, ears . );
- Limbs (arms, legs, etc blood flow restrictions, etc.);
- Bodily Fluids (spectral analysis of bodily fluids using the Med-Sense hyperspectral sensor can be applied to characterize saliva, blood, urine....);
Example 1: Integrated Sensor Suite:
[042] The device comprises a combination of sensors configured in a manner that enables a host of medical screening and recording tests to be conducted more efficiently than currently possible. Specifically, the device comprises one or more of the following sensors, devices or components:
- Video cameras with motorized servo driven auto-focus, slew focus, zoom and aperture control;
- Thermal Camera;
- Hyperspectral Imaging Sensor; - LED, Laser and Lidar sensors for distance measuring, waveform measuring and other light sensing parameters to measure transparency, opacity, index, discoloration;
- Motorized Positioning Gimbal to position the device relative to a subject and / or to scan the entire body or parts of the body;
- Motorized Elevator for Height Control to automatically adjust the device to the height of the person;
- Interactive Display Screen including but not limited to a Touch Screen Display for certain configurations;
- Illumination sources including but not limited to broad spectrum or narrow band LED or Laser sources;
- Acoustic sensors as well as devices including speakers and microphone for communicating with the subject through remote access telehealth professionals or Al trained interactive interfaces to respond to questions and provide direction audibly and via text (whether a subject is hearing impaired or blind);
- Pressure sensors;
- Software Algorithms; and
- Secure Data Storage Device CHQR.
Example 2: Eye Exams
[043] To conduct eye exams the device is configured with combination of optical cameras, which are aimed at a subject to perform a detailed eye exam which can make measurements including, but not limited to, eye shape parameters, color, curvatures, cloudiness and relative eye positions by measuring position of both eyes accurately and tracking relative eye motion. Relative eye positions are measured by accurately measuring the geometric axis of each eye, providing information regarding eye misalignments such as strabismus, double vision, loss of depth perception or other eye conditions that cause blurred vision, strain, fatigue, pain, and/or motion sickness. The platform may be configured to measure other eye conditions including "dry eye," and to make ophthalmological measurements of the eye including shape for eye wear or visual aids, as well as detecting other eye conditions such as cataracts, and even glaucoma by accurately measuring the shape of each eye relative to standard measurements where such measurements can aid subsequent surgery.
[044] The Med-Sense array of multiple optical imaging sensors have zoom control in order to magnify the optical view to perform as a stand-off microscope or long-distance microscope to make measurements of the retina. The innovative combination of zoom lens control and multiple cameras have the ability to image the retina for measuring damage or potential detachment and when combined with light measurements are able to assess the opacity of the eye, focal length of the lens, distortion of the eye either on-axis or off-axis providing a convenient measurement for eye correction. In addition transparency and discoloration can be measured in order to determine other conditions such as cataracts, Fuchs disease, etc.

Claims

What is claimed is:
1. A medical diagnostic device comprising a head unit and a vertical lift stage, the head unit comprising
- multi-targeting LIDAR;
- at least two visible light cameras;
- a thermal imaging camera;
- a hyper-spectral imaging camera;
- a light source;
- an audio speaker; and
- a microphone.
2. The device of claim 1, wherein the head unit is connected to the vertical lift stage via a dualaxis scanning gimbal.
3. The device of claim 1, wherein the head unit is connected to the vertical lift stage via a motorized positioning gimbal.
4. The device of claim 1, wherein the head unit further comprises a tilt sensor.
5. The device of claim 1, further comprising a display attached to the head unit and configured to display information to a patient.
6. The device of claim 5, wherein the display is a touch screen display.
7. The device of claim 1, wherein the light source is a broad-spectrum LED light source, a narrow-spectrum LED light source, or a laser light source.
8. The device of claim 1, further comprising a mobile platform to which the vertical lift stage is mounted.
9. The device of claim 8, wherein the mobile platform comprises multiple wheels.
10. The device of claim 9, wherein the mobile platform further comprises a motor operably connected to the wheels.
11. The device of claim 1, wherein the head unit further comprises a computer processor.
12. The device of claim 11 further comprising a data storage unit.
13. The device of claim 1, wherein the visible light cameras comprise auto-focusing and 3D imaging systems.
14. The device of claim 1, wherein the visible light cameras comprise motorized servo driven autofocus, slew focus, zoom, and aperture control.
15. The device of claim 1, wherein the vertical lift stage comprises a motorized elevator configured to adjust the height of the head unit to conform to the height of a patient.
PCT/US2023/079183 2022-11-09 2023-11-09 Automated medical observation and diagnostic platform WO2024102878A1 (en)

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Citations (4)

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US20150308896A1 (en) * 2012-06-05 2015-10-29 Hypermed Imaging, Inc. Methods and apparatus for coaxial imaging of multiple wavelengths
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US20170150903A1 (en) * 2008-05-23 2017-06-01 Spectral Image, Inc. Systems and methods for hyperspectral medical imaging
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