Derma diagnostic and automated data analysis system

• US 20080161661A1
• Filed: 01/03/2007
• Published: 07/03/2008
• Est. Priority Date: 01/03/2007
• Status: Active Grant

• Current Assignee: Theodore M. Gizewski
• Original Assignee: Theodore M. Gizewski
• Inventors: Gizewski, Theodore M.
• Granted Patent: US 8,109,875 B2
• Time in Patent Office: Days
• US Class Current: 600/306
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• CPC Class Codes: A61B 5/0013 Medical image data A61B1/00011, A61B6/56, A61B8/56 take precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0064 Body surface scanning
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/442 Evaluating skin mechanical properties, e.g. elasticity, hardness, texture, wrinkle assessment
• CPC Class Codes: A61B 5/445 Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
• CPC Class Codes: A61B 5/7465 Arrangements for interactive communication between patient and care services, e.g. by using a telephone network telemetry of measured physiological signal A61B5/0002
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

Disclosed is a derma diagnostic and automated data analysis system configured to acquire an array of data pertaining to a subject and their skin disorders. This data is subjected to a comprehensive analysis that culminates in diagnoses, treatments, monitoring activity and health strategy implementation. The derma diagnostic and automated data analysis system comprises a user interface and display unit, capable of acquiring a range of subject data, and communicatively coupled to a remotely located data analysis and reporting unit. The data analysis and reporting unit is capable of receiving and assessing the acquired data, using multiple analytical processes that culminate in a highly probable diagnosis and an effective treatment that is documented in a report and submitted to the subject. The diagnoses, treatments and supporting data are then permanently archived and made available for retrieval.

Claims

1. A derma diagnostic and automated data analysis system, comprising:

at least one user interface and display unit capable of interacting with a subject and acquiring subject data from the subject; and

at least one data analysis and reporting unit communicatively coupled to the user interface and display unit, the data analysis and reporting unit capable of

remotely controlling the interactions between the user interface and display unit and the subject, and

acquiring and analyzing subject data for developing diagnosis, prescribing treatments, initiating monitoring processes, prescribing health strategies, generating health reports, archiving diagnoses and treatments, and assessing compilation of data for identifying correlations and influencing factors for enhancing accuracy of diagnoses and effectiveness of treatments.

2. The derma diagnostic and automated data analysis system of claim 1, wherein the subject data is selected from at least one of sensory data, imagery data, test and measurement data and supportive data.

3. The derma diagnostic and automated data analysis system of claim 1, wherein the user interface and display unit is communicatively coupled to the data analysis and reporting unit through a communication network comprising at least one of Internet, public switched telephone network, global system for mobile communications network, and general packet radio service network.

4. The derma diagnostic and automated data analysis system of claim 1, wherein the user interface and display unit comprises a data acquisition module, an image selection and adjustment module and a display module, the data acquisition module having

an imagery and sensory data unit capable of detecting and digitally capturing a plurality of skin characteristics in the form of quantitative imagery data,

a breath analyzer capable of analyzing the subject'"'"'s exhaled breath for identifying the presence and concentration of molecules and chemical compounds indicating the presence of a disease, imbalance or abnormality,

a test and measurement unit capable of capturing multiple physical and physiological subject characteristics, and multiple environmental characteristics, and

a supportive data unit capable of acquiring an array of supportive data;

the image selection and adjustment module works in conjunction with the data acquisition module and the display module for interacting with the subject for selecting, modifying, and optimizing the imagery data, sensory data, test and measurement data, and the supportive data; and

the display module capable for interfacing with the subject for facilitating two way communication between the subject and the derma diagnostic and automated data analysis system for presenting information, graphical imagery, sensory data, queries, test set-up instructions and reports using at least one of touch-screen display, mouse, stylus, and keyboard.

5. The derma diagnostic and automated data analysis system of claim 1, wherein the data analysis and reporting unit further capable of

systematically constructing and presenting a logical sequence of interactive queries designed for acquiring supportive data from the subject,

systematically orchestrating administration of a logical sequence of special tests and measurements designed for acquiring imagery data, sensory data, and a series of physical, physiological, psychological and environmental tests and measurements,

collecting and analyzing data captured by the data acquisition module for establishing a diagnosis and selecting and implementing suitable treatments, avoidance and mitigation strategies, condition monitoring programs, and treatment/strategy effectiveness monitoring programs,

performing systematic reviews of the diagnoses and prescribed treatments,

developing a set of health status reports for transmitting to the user interface and display unit for presentation to the subject,

permanently archiving the subject'"'"'s background data, health data, diagnoses and treatments, and

assessing cumulative data in order to identify important factors influencing the accuracy of diagnosis and effectiveness of treatments and health maintenance strategies.

6. The derma diagnostic and automated data analysis system of claim 4, wherein the imagery and sensory data unit acquires an array of skin condition characteristics using

at least one stationary digital image scanner,

at least one portable digital image scanner, and

at least one digital camera.

7. The derma diagnostic and automated data analysis system of claim 6, wherein the stationary digital image scanner configuration includes

at least one horizontal digital image scanner capable of imaging bodies lying in horizontal position, and

at least one vertical digital image scanner capable of imaging bodies standing vertically.

8. The derma diagnostic and automated data analysis system of claim 7, wherein the stationary digital image scanners acquire imagery data of the subject'"'"'s skin using

white-light digital photography for detecting, locating areas-of-interest in reference to fixed datum points and capturing white-light, high-contrast ratio, high-color saturation, high-color accuracy and high-resolution, scaled imagery of skin irregularities, abnormalities or peculiarities, on the subject'"'"'s skin as either individual digitized photographs or streamed video,

fluorescence spectroscopy for detecting, locating and capturing scaled fluorescent spectroscopic properties associated with skin irregularities, abnormalities, and peculiarities, on the subject'"'"'s body as either individual digitized images or streamed video, and

high definition infrared (IR) imagery for detecting, locating and capturing body temperature and scaled radiometric spectroscopic properties of skin irregularities, abnormalities or peculiarities, on the subject'"'"'s body as either individual digitized images or streamed video.

9. The derma diagnostic and automated data analysis system of claim 6, wherein the portable digital image scanner is compact, robust, portable and shares performance capabilities and data acquisition objectives of the stationary digital image scanners, the portable digital image scanner includes

a derma imager-white-light photographic (WLP) capable of detecting, locating area-of-interest in reference to fixed datum points and capturing white-light, high-contrast ratio, high-color saturation, high-color accuracy and high-resolution, scaled imagery of skin abnormalities, irregularities, and peculiarities, on the subject'"'"'s body as either individual photographs or streamed video,

a derma imager-fluorescence spectroscopy (FS) capable of detecting, locating and capturing scaled fluorescent spectroscopic properties associated with skin irregularities, abnormalities and disorders found on the subject'"'"'s body as either individual images or streamed video, and

a derma imager-thermo-graphic infrared (IR) capable of detecting, locating and capturing scaled radiometric spectroscopic properties associated with skin irregularities, abnormalities and disorders, found on the subject'"'"'s body, as either individual images or streamed video.

10. The derma diagnostic and automated data analysis system of claim 6, wherein the digital camera is capable of capturing color photographic images, of skin conditions and skin abnormalities, and submitting the images, over the communication network, to the user interface and display unit for processing.

11. The derma diagnostic and automated data analysis system of claim 4, wherein the presence and concentration of molecules or chemical compounds detected by the breath analyzer correlate to hormonal levels, chemical imbalances, metabolic performance, inflammation, disease, infection and other localized or major organ system conditions manifesting as skin peculiarities, irregularities, abnormalities or disorders.

12. The derma diagnostic and automated data analysis system of claim 4, wherein the display module, further comprises user interface features including

audio communication features for two way audio communication between the subject or operator and the derma diagnostic and automated data analysis system,

video communication features for visual communication of messages, images, graphics, alerts, instructions, reports, and general information, and

data security features for preventing infection, corruption, alteration, debasement effecting the integrity of data or the derma diagnostic and automated data analysis system, and further preventing unauthorized access, including viewing of data, applications, processes, procedures, reference materials and other sensitive, private, and/or proprietary data contained in the derma diagnostic and automated data analysis system.

13. The derma diagnostic and automated data analysis system of claim 4, wherein the supportive data unit works collaboratively with the data analysis and reporting unit for acquiring an array of personal identification data selected from at least one of physical descriptive data, demographics data;

personal hygiene data;

health history data;

medical history data;

family health history data;

travel history data;

behavioral data;

diet/nutritional data;

mental health data;

home/work environmental data;

nuclear/biological/chemical substance exposure data;

skin condition symptoms and skin condition history data;

occupation descriptive data;

allergy data;

prescription and nonprescription drug usage data;

cosmetics usage data;

genetic predisposition data;

sleeping habits;

exposure to contagious and infectious diseases;

exposure to fungal infections;

exposure to parasitical infections and environmental exposure data.

14. The derma diagnostic and automated data analysis system of claim 1, wherein the data analysis and reporting unit comprises

a data requirements and communications module,

a data analysis module, and

a reporting module.

15. The derma diagnostic and automated data analysis system of claim 14, wherein the data requirements and communications module is capable of

interfacing with the user interface and display units, through the communication network, for interacting with the operator or subject and orchestrate the data acquisition processes, diagnosis and treatment reporting process, health strategy implementation processes, avoidance and mitigation strategy implementation processes, condition monitoring implementation processes, and treatment effectiveness and strategy effectiveness monitoring implementation processes,

systematically monitoring the collection and quality of imagery data, sensory data, test and measurement data;

and supportive data acquired through the user interface and display units,

preparing the imagery data, sensory data, test and measurement data, and supportive data for analyzing and routing to the data analysis module,

interacting with the data analysis module for acquiring new, additional, and/or modified subject data as needed for performing data analysis,

monitoring the user interface and display units for operational availability and performance, and

maintaining system security.

16. The derma diagnostic and automated data analysis system of claim 14, wherein the data analysis module comprises an analyzer module capable of

detailed and comprehensive analysis of imagery data, sensory data, test and measurement data, and supportive data acquired through the data acquisition module,

developing diagnoses of skin conditions, skin abnormalities and skin disorders,

identifying treatment options for each diagnosis,

developing avoidance and mitigation strategies,

developing health enhancement strategies,

establishing condition monitoring criteria, assessing and responding to monitoring results,

establishing treatment and strategy effectiveness monitoring criteria, assessing and responding to monitoring results,

permanently archiving the analyzed data, and

assessing cumulative data in order to identify important factors and correlations influencing accuracy of diagnosis, and effectiveness of treatments and health maintenance strategies, and

assessing cumulative data to identify peculiar or deviant patterns and trends indicating early evidence of occurrence of a health phenomenon.

17. The derma diagnostic and automated data analysis system of claim 16, wherein the detailed and comprehensive analysis comprises at least one of comparative analysis, patterns and trends analysis, correlation analysis, risk analysis, and health strategy analysis.

18. The derma diagnostic and automated data analysis system of claim 16, wherein the diagnoses of skin conditions, abnormalities and disorders is derived from the analysis and includes one or more diagnoses, with the primary or most probable diagnosis presented first and the secondary diagnoses retained for reference and reassessment as condition monitoring and treatment effectiveness monitoring progresses.

19. The derma diagnostic and automated data analysis system of claim 16, wherein the treatment options are based on

nature, cause, and severity of the condition,

subject considerations including demographic characteristics, physical/physiological/psychological and behavioral characteristics, occupation, medical history, current medical condition(s), allergies, health history, current conditions, preferences, prescription and nonprescription drug usage, genealogical predispositions, diet/nutrition, physical fitness, sleep patterns, predispositions and preferences, and

secondary diagnoses considerations.

20. The derma diagnostic and automated data analysis system of claim 16, wherein the avoidance and mitigation strategies, targeting susceptibility to specific skin conditions, are designed to

sensitize the subject to be aware of environmental, microbial, chemical, nuclear, insect, animal and human dangers or hazards causing, spreading or exasperating a particular skin condition,

offer strategies for controlling or lessoning the intensity or severity of a skin condition or skin disorder including diet/nutrition modification, immunizations, personal hygiene optimization, prescription and nonprescription treatments, desensitization, behavior modification, cosmetics and skin care product optimization, soaps/detergents/cleaning product optimization, contamination recognition, protective clothing and safety equipment, and

offer emergency intervention and decontamination in case of exposure to at least one of hazardous chemical spills, environmental pollutants, infestations, nuclear/biological/chemical contamination, and injury.

21. The derma diagnostic and automated data analysis system of claim 16, wherein the health enhancement strategies target the enhancement of the subject'"'"'s general health and immune system for augmenting resistance to, or mitigating the effects of, contamination, infection, disease, skin injury or damage, parasites, fungal infections, irritation, inflammation, skin degradation due to aging, and includes personalized strategies for behavior modifications, diet/nutrition optimization, vitamin and mineral supplement regimens, stress reduction strategies, exercise regimes, skin care optimization, hygiene optimization, clothing optimization, home environment optimization, work environmental hazard avoidance, sleep optimization, protective emergency gear, and sensitivity to detection and identification of skin irregularities and abnormalities.

22. The derma diagnostic and automated data analysis system of claim 16, wherein the condition monitoring criteria consists of specific monitoring parameters, milestones and instructions for supporting the user interface and display unit in effectively tracking and gauging the progression of a skin condition or skin disorder.

23. The derma diagnostic and automated data analysis system of claim 16, wherein the treatment and strategy effectiveness monitoring criteria consists of specific monitoring parameters, milestones and instructions for supporting the user interface and display unit in tracking and gauging the subject'"'"'s response to, and effectiveness of a treatment and/or health strategy.

24. The derma diagnostic and automated data analysis system of claim 16, wherein permanently archiving analyzed data consists of collecting, centrally storing and making available, for retrieval by the subject and subject'"'"'s authorized representatives including emergency medical practitioners, the subject'"'"'s identification data, demographic data, physical/physiological/psychological and behavioral data, current health conditions, medical histories, health histories, skin condition descriptions/symptoms, test and measurement results, diagnoses, treatments, avoidance and mitigation strategies, health enhancement strategies, condition monitoring data, treatment and strategy effectiveness monitoring data, and core diagnostic premises.

25. The derma diagnostic and automated data analysis system of claim 16, wherein the data analysis module further comprises a review function having one or more qualified health care professionals capable of reviewing and modifying the automated diagnoses and treatments.

26. The derma diagnostic and automated data analysis system of claim 14, wherein the reporting module is configured to generate and transmit health status reports including diagnoses and treatments, health strategies, and monitoring criteria to the subject over the communication network.

27. The derma diagnostic and automated data analysis system of claim 26, wherein the reporting module is capable of generating at least two output report formats including

a plain language formatted report having a summary of the subscriber'"'"'s health condition, the diagnoses and proposed treatments, the monitoring parameters and monitoring results, and

a medically formatted report, designed to be read by health care professionals, comprising formal and comprehensive descriptions of the subject'"'"'s health condition, diagnoses, proposed treatments, and rational behind diagnoses and treatments.

28. The derma diagnostic and automated data analysis system of claim 4, wherein test and measurement unit is available in stationary and portable configuration, the test and measurement unit capable of capturing quantitative measurements of

subject'"'"'s physical features including height, weight, body dimensions, body fat ratios, posture, skin tone/shade, eye color, hair color, and hair density and thickness,

subject'"'"'s physiological characteristics including vital signs, bone density, muscular/skeletal strength and flexibility, blood oxygen levels, skin thickness, skin texture, skin translucence, skin elasticity, skin moisture content, blood type, skin sensitivity, gait, posture, strength and strength symmetry, vision, eye clarity, hearing, hair loss and hair condition, fingernail characteristics, and hormone levels, and

test environment, including ambient temperature, humidity, elevation, air quality, geographical location, and calendar day and time of day.

29. The derma diagnostic and automated data analysis system of claim 28, wherein the test and measurement unit further capable of importing medical data, laboratory test results and test results derived from a variety of test devices external to the derma diagnostic and automated data analysis system.

30. A method of performing automated data analysis for diagnosing subject'"'"'s skin disorders and prescribing treatments, the method comprising:

acquiring preliminary subject information, including basic demographic data, general background data and a overview description of skin condition, using user-interface features of a user interface and display unit;

transmitting the acquired preliminary subject information to a data analysis and reporting unit over a communication network;

processing preliminary subject information for establishing a data acquisition strategy and implementation process;

transmitting the data acquisition strategy implementation process, over the communications network, to the user interface and display unit;

systematically acquiring prescribed supportive data and skin condition imagery, sensory, and test and measurement data based on the established data acquisition strategy and implementation process;

transmitting the acquired supportive data and skin condition imagery, sensory, and test and measurement data, over the communications network, to the data analysis and reporting unit;

analyzing the data and developing primary and secondary diagnoses and treatments, monitoring criteria, and health strategies;

generating a series of health status reports incorporating diagnoses, treatments, monitoring criteria, and health strategies, and transmitting the health status reports, to the user interface and display unit, over the communications network;

presenting the health status reports to the subject;

administering the treatment and monitoring activities;

continuously acquiring data updates and monitoring results and transmitting, over the communication network, to the data analysis and reporting unit; and

continuously reassessing the updated data and monitoring data, and adjusting the data acquisition requirements, diagnoses and treatments as appropriate.

31. The method of claim 30, wherein the data analysis and reporting unit further capable of remotely managing the condition monitoring implementation, treatment effectiveness monitoring implementation, avoidance and mitigation strategy implementation, health strategy implementation, and strategy effectiveness monitoring implementation through the user interface and display unit.

32. The method of claim 30, wherein the user interface and display unit interacts with the subject for implementing condition monitoring, treatment effectiveness monitoring, avoidance and mitigation strategies, health strategies, strategy effectiveness monitoring activities and further continuously provides updates to the data analysis and reporting unit.

33. The method of claim 30, wherein the data analysis and reporting unit further capable of

implementing a cycle for assessing updates, provided by the user interface and display unit, and adjusting data acquisition requirements, providing feed-back, updating diagnoses and treatments, administering monitoring activities, and providing clarifications and instructions, and

permanently archiving data comprising demographic data, physical characteristics, physiological characteristics, psychological characteristics, behavioral characteristics, family health history, diagnoses, treatments, health history, and medical history, available for retrieval by the subject and the subject'"'"'s authorized representatives including emergency medical practitioners.

34. The method of claim 30, wherein the data analysis and reporting unit is communicatively coupled to the user interface and display unit through a communication network selected from at least one of Internet, public switched telephone network, global system for mobile communications network, and general packet radio service network.