WO2010029427A1 - Dispositif et système de test et de montage - Google Patents

Dispositif et système de test et de montage Download PDF

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Publication number
WO2010029427A1
WO2010029427A1 PCT/IB2009/006821 IB2009006821W WO2010029427A1 WO 2010029427 A1 WO2010029427 A1 WO 2010029427A1 IB 2009006821 W IB2009006821 W IB 2009006821W WO 2010029427 A1 WO2010029427 A1 WO 2010029427A1
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WIPO (PCT)
Prior art keywords
data
user
communications
information
party
Prior art date
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PCT/IB2009/006821
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English (en)
Inventor
Kenneth Barton
Stanislav Sokolov
Murphy Palmer
Original Assignee
Kenneth Barton
Stanislav Sokolov
Murphy Palmer
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Application filed by Kenneth Barton, Stanislav Sokolov, Murphy Palmer filed Critical Kenneth Barton
Publication of WO2010029427A1 publication Critical patent/WO2010029427A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1112—Global tracking of patients, e.g. by using GPS
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/7465—Arrangements for interactive communication between patient and care services, e.g. by using a telephone network
    • A61B5/747—Arrangements for interactive communication between patient and care services, e.g. by using a telephone network in case of emergency, i.e. alerting emergency services
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A61B5/0013—Medical image data
    • 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
    • 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
    • A61B5/021—Measuring pressure in heart or blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • 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

Definitions

  • Embodiments of the invention relate to methodologies, systems and associated methodologies for supporting devices (hard-wired devices and wireless devices) used for measuring and/or testing (e.g., by medical personnel) and monitoring including for testing, self-testing and self-monitoring (e.g., medical patients).
  • These methodologies, systems and associated methodologies for supporting these devices include the integration into electronic systems and records (e.g., patient electronic medical records); evaluating pre-set testing parameters that trigger interactive notifications (e.g., clinical and emergency notifications, primary care physician/medical professional notifications, and patient notifications).
  • These methodologies, systems and associated methodologies for supporting these devices also include integration into other systems (e.g., insurance billing systems, communications and network support billing systems, medical billing systems, patient management systems, practice management systems and similar systems used for tracking and maintaining patient and clinical information).
  • the healthcare application of the system supports devices inside and/or outside of a Point of Care or clinical location ("PATIENT TESTING AND MONITORING DEVICE SUPPORT SYSTEM” or "PTMSS”).
  • Notification of patient test or monitoring problems is done by an alarm on a nurses' station screen, phone call, pager or public address type system to the responding medical personnel within the facility.
  • This requires significant human labor for interaction and coordination by multiple parties to monitor and react to patient condition changes as recorded by current testing and monitoring devices.
  • These Patient Testing and Monitoring devices are for constant patient monitoring, not for periodic testing (i.e., blood glucose levels).
  • Such Systems provide limited functionality and do not provide a fully integrated solution.
  • Current data systems are mostly field fill structures that require manual queries by a trained operator to retrieve information.
  • the information is not regularly integrated by indices, collated or monitored for specific parameters and provide limited functionality in applications such as automatic notification (e.g., clinical alerts).
  • the Systems were designed for specific purposes as stand alone solutions with limited or no designed interoperability.
  • the medical business does not fully understand the communications business and has predominantly sought communications support for specific applications and not overall patient care and management solutions.
  • the US Federal Communications Commission (FCC) in the US, the European Union Communications Ministry (EUC) and the International Telecommunication Union (ITU) has yet to establish finite guidelines and frequencies for use in clinical environments.
  • FCC Federal Communications Commission
  • EUC European Union Communications Ministry
  • ITU International Telecommunication Union
  • One accomplishment has been to promote the testing of existing wireless communications for interference with the operation of electronic medical equipment. This has been done so that the health care community as a whole understands what wireless device frequencies and power levels are acceptable for use in clinical/hospital settings to reduce the risk of interfering with electronic medical equipment.
  • the US FCC, EUC and ITU are the leading authorities in establishing communications protocols worldwide.
  • the structure of the communications business can be complicated for those not directly involved.
  • the basic structure involves Equipment Manufacturers, licensed Common Carriers, Regional Operating Companies, Resellers, Wireless Carriers, Rural Telephone Companies, Cable Companies, Internet Service Providers and Local Exchange Carriers. It is a daunting task for anyone that has little or no knowledge of communications to figure out who to go to and what to ask for when it comes to any type of communications support. Therefore, any system proposed usually fails or has limited effect due to a lack of understanding of the requirements of either party in their respective businesses.
  • Wireless support of medical testing and monitoring devices outside of a clinical setting has yet to be embraced by the Wireless Carrier business.
  • Carriers are focused more on providing mobile phone, text messaging, Internet access and content delivery to the consumer market as these are the major profit centers.
  • the very structure of the Wireless Carrier business limits access by virtue of the way the business is organized. In order to sell a Carriers service, one must enter into a "Reseller Agreement" in order to provide "private label" service to customers.
  • MVNO Mobile Virtual Network Operator
  • [001 1] A single/multiple chip(s) that contains the processor (the CPU), non-volatile memory for the program (ROM or flash), volatile memory for input and output (RAM), a clock and an I/O control unit.
  • a method or piece of equipment enabling transfer of information over a distance without the use of electrical conductors or "wires" not using radio frequencies.
  • ENCRYPTION/DECRYPTION MODULE (5) [0019] Module for encrypting and decrypting communications. [0020] COMMUNICATIONS MODULE (6):
  • Module that is capable of sending and receiving communications via wireless means.
  • This module includes Global Positioning System (GPS) capabilities.
  • GPS Global Positioning System
  • SIM subscriber identity module
  • IMSI service- subscriber key
  • a SIM card contains its unique serial number, international unique number of the mobile user (IMSI), security authentication and ciphering information, temporary information related to the local network (also temporary local id that has been issued to the user), a list of the services the user has access to and two passwords (PIN for usual use and PUK for unlocking).
  • IMSI international unique number of the mobile user
  • PIN password for usual use and PUK for unlocking
  • a device for converting sound into electrical energy [0027]
  • Electro-acoustic transducer that converts electrical signals into sounds loud enough to be heard at a distance.
  • a video interface designed to provide visual information on digital display devices such as el LCD/OLED displays, etc..
  • a display that can detect the presence and location of a touch within the display area.
  • the term generally refers to touch or contact to the display of the device by a finger or hand.
  • Touch screens can also sense other passive objects.
  • the ability to interact directly with a display typically indicates the presence of a touch screen.
  • a device that can scan a fingerprint to be used to compare the digitized image/data with fingerprints in a database of authorized users.
  • a piece of equipment used for taking photographs or pictures that encodes an image digitally and store it for later reproduction.
  • a Device that measures readings to identify characteristics [0049] A Device that measures readings to identify characteristics.
  • a module that measures biophysical parameters [0051] A module that measures biophysical parameters.
  • a method or piece of equipment enabling transfer of information over a distance with the use of electrical conductors, fiber optic or wired means.
  • a terminal/computer connected to a computer system by a data link.
  • Biometric readers other then finger print scanners such as a biometric eye-scanner.
  • a M2M universal communication device that is able to communicate with third party medical testing devices and automatically transmit the generated data from these products to the central computer system with minimum to no additional user involvement.
  • the communicator allows for patient interaction to append measurement / testing results taken by third party products. Additional functionality includes GPS capabilities, photographic capabilities, alert functionality, biometric user validation, voice communication capabilities, encryption and decryption capabilities.
  • a patient testing and monitoring device support system for the remote testing and monitoring of patients' physiological information (e.g. diabetes testing, blood pressure testing, anti-coagulation, etc.).
  • the System allows existing testing and monitoring devices manufactured by third party companies (e.g., Johnson and Johnson, Bayer, Roche, etc.) to communicate with the System through existing landline or wireless means enabled by machine-to-machine technology.
  • the System gives general practitioners an additional tool to more effectively diagnose and provide initial treatment for chronic diseases (e.g., diabetes, heart disease, etc.) in early stage care. Having the ability to treat early onset of chronic diseases, such as diabetes, in a timely manner can reduce healthcare costs and the onset of additional, more serious maladies that typically can accompany these diseases.
  • chronic diseases e.g., diabetes, heart disease, etc.
  • the System provides: (i) significant reduction of healthcare costs, (ii) true continuity of care; (iii) interactive clinical alert solutions; (iv) support for a interactive disease management system; (v) practice management "best practices”; (vi) patient discharge management; and (vii) full integration into existing systems and; (viii) secure identity management through biometrics.
  • the System is able to establish communications via cellular networks, wireless terrestrial broadband, landline, satellite based networks, the Internet, and support in-bound and out-bound communications via text, email, voice, conversation, and electronic data exchange, and store the information in proper formats linked to patient profile and data tables in the system.
  • the system also communicates with other Point-of-Care and external resources, such as patient medical records management entities and/or archives, insurance carrier and medical billing systems, hospitals and doctors.
  • the System also by design manages the proper protocols for exchanging information in support of the patient's file.
  • a printed page or image transmitted or received by a fax machine is transmitted or received by a fax machine.
  • SMS stands for short message service. SMS is also often referred to as texting, sending text messages or text messaging. The service allows for short text messages to be sent from one cell phone or personal communications device to another cell phone or personal communications device or system via the Web or from a system via the Web to cell phone or personal communications device.
  • a device capable of remote receiving/ transmitting voice communications capable of remote receiving/ transmitting voice communications
  • IDA Intelligent Data Analysis
  • AI Artificial Intelligence
  • NLP Natural Language Processing
  • Intelligent Data Analysis provides a forum for the examination of issues related to the research and applications of Artificial Intelligence techniques in data analysis across a variety of disciplines. These techniques include (but are not limited to): all areas of data visualization, data preprocessing (fusion, editing, transformation, filtering, sampling), data engineering, database mining techniques, tools and applications, use of domain knowledge in data analysis, evolutionary algorithms, machine learning, neural nets, fuzzy logic, statistical pattern recognition, knowledge filtering, and post-processing.
  • AI is the ability of a computer to continually build a knowledge base of rational components, just as we humans continually learn and evolve in our thought processes. The difference is that the computer learns faster (knowledge base building) and never forgets what it has "learned”. The ability of a computer to continually build its knowledge base and retrieve, use, apply known rationale and logically calculate solutions in real time is AI.
  • Natural Language Processing is the ability of a computer to recognize human speech and convert it to usable data for processing as text, data, or translating it to another language. This is accomplished in the same fashion as AI in the computer. It has a continually building knowledge base and perpetually refines this knowledge base as it grows. NLP is not simple word recognition. It has evolved into understanding entire bodies of speech and even works of text. Today's advanced NLP technology applies to both speech and text. Additionally, there are image recognition technologies that have been integrated into AI/NLP that now allow computers to essentially "see, hear, speak, translate and write”.
  • a database of information that includes user, data elements, inputs, processes, outputs and interrelationships.
  • a repository is used by the system in order to identify objects and business rules for reuse.
  • the Patient Information Management System is the central repository of all patient testing data, historical data, profiling data, etc. Eveiy patient's measurement is stored here for realtime and post-factum analysis. Health care providers store information regarding individual alerts per patient as well as per class of patients and global alerts here (example: life-threatening values that will trigger alerts). PIMS is also a repository of transcripts of communications between patients and the System, health care provider or emergency response personnel. PIMS can become a repository of structured and unstructured information about patient. It stores patient profiles in addition to metaknowledge about the patients. All manipulations on the data are audited; data access works according to an Access Control List (ACL); all data is secured to comply with HIPAA and appropriate requirements and standards.
  • ACL Access Control List
  • PIMS includes a set of redundant DBs with Web Service Layer APIs. This allows loose coupling of components and ability for 3rd party medical systems (like EHR Electronic Health Record systems) to be seamlessly integrated with the System.
  • the system is capable of understanding the dialog context of the call and remembering the caller's preferences, knowledge base information from previous calls and other relevant data. In subsequent calls, callers will not have to answer the same questions again, greatly enhancing their experience. If a call is interrupted, the system will call the patient/customer back and pick up the conversation where it left off (where applicable).
  • POC Point Of Care
  • small networks used for the connection of subassembli.es and usually contained in a single piece of equipment
  • LAN Local Area Networks, or LAN, cables or fibers used to connect computer equipment and other terminals distributed in a localized area, such as on a college campus
  • Metropolitan Area Networks, or MAN a high-speed network used to interconnect LANs spread around a small
  • a user is the person that a software program or hardware device is designed for (e.g., the patient Math regards to a remote patient monitoring system).
  • a device or devices that dispense a patient's medication per instructions from a system that it is connected to through a communication network is connected to through a communication network.
  • An authorized person that has administrative access to view and/or change information in the system. This includes a person employed to maintain and operate a computer system and/or network and/or the person employed who installs, configures, and otherwise maintains the software (and possibly the hardware) associated with a computer system and/or an authorized person that can review and change information, settings and parameters in a users profile on the system.
  • a network device that combines a wireless access point (base station), a wired LAN switch and a router with connections to a cable or DSL service.
  • Wireless routers provide a convenient way to connect a small number of wired and any number of wireless computers to the Internet.
  • Wireless broadband falls into local and wide area categories.
  • Wireless local area networks namely 802.11 Wi-Fi networks
  • WWANs wireless wide area networks
  • EDGE and 3G EV-DO and HSPA
  • a computer that is connected to other computers via modem (examples: telephone, cable, DSL).
  • modem examples: telephone, cable, DSL.
  • HEALTH CARE MEDICINE PROVIDER (51):
  • Waveform synthesis includes the artificial production of human speech.
  • a computer system used for this purpose is called a speech synthesizer, and can be implemented in software or hardware.
  • a text-to-speech (TTS) system converts normal language text into speech; other systems render symbolic linguistic representations like phonetic transcriptions into speech.
  • Synthesized speech can be created by concatenating pieces of recorded speech that are stored in a database.
  • Systems differ in the size of the stored speech units; a system that stores phones or diphones provides the largest output range, but may lack clarity.
  • a component that generates a provisionally accepted hypothesis based upon incoming data and analysis utilizing algorithms applicable for process is a provisionally accepted hypothesis based upon incoming data and analysis utilizing algorithms applicable for process.
  • the speech recognizer is able to produce a list of possible words, i.e. a collection of potentially meaningful sentences or sentence fragments, typically represented as a network (a directed acyclic graph). These potential sentences must be converted into logical expressions (propositions), which the dialog system can understand.
  • This "conversion process” can be divided into two autonomous modules: Syntactic parsing and Semantic parsing. This suggests the following general model for the language analysis modules:
  • syntactic analyzer performs dictionary lookup from the system's lexical database and applies syntactic rules to these word descriptions.
  • the result of this process which is called syntactic parsing, is declarative descriptions of the syntactic content (subject, object, adverbials, etc.) of each proposed sentence or sentence fragment, as suggested by the speech/word recognizer.
  • the semantic module will continue the analysis, and it must, among other things, pick out the most suitable interpretation from the input network provided by the speech recognizer.
  • a performance monitoring module that senses current system processes' states and manages system resource allocation to ensure optimal use.
  • VSA Voice Stress Analysis
  • Component contains data on a phonetic, syntactical and semantic structure of human languages.
  • Component engaged in process of analyzing and identifying the auditory-perceptual and acoustic characteristics of a given voice sample and assigning it to speaker profile.
  • Component engaged in process of analyzing and identifying the auditory-perceptual and acoustic characteristics of a given voice sample and assigning it to speaker profile.
  • S elf-diagnostic/self- testing system controls test parameters within the system to verify that all system components are functioning properly.
  • the Executor arranges collaboration and divides up the responsibilities for the components to operate.
  • Component that carries functionality of analyzing reaction/feedback of the system to process- controlling steps, generated by predictor/corrector algorithms.
  • Predictor/Corrector is module that implements formal and fuzzy logic functionality as well as algorithms of predictability of close and open systems to generate process-controlling steps.
  • the network interface is the point of interconnection between a user terminal and a private or public network.
  • System of User Life Cycle Management and testing / measurement support This system includes administrative access to establish, review, edit, user accounts / user customer service subsystem and billing subsystem.
  • a network device that converts voice and fax calls, in real time, between the public switched telephone network (PSTN) and an IP network.
  • PSTN public switched telephone network
  • IP network IP network
  • the primary functions of a VoIP gateway include voice and fax compression/decompression, packetization, call routing, and control signaling. Additional features may include interfaces to external controllers, such as Gatekeepers or Soft switches, billing systems, and network management systems.
  • DSP digital signal processor
  • Digital signal processing algorithms typically require a large number of mathematical operations to be performed quickly on a set of data. Signals are converted from analog to digital, manipulated digitally, and then converted again to analog form.
  • Biometric Identification Module [0175] Scanned biometric (Ex. fingertip, iris) data: [0176] Previously Stored User ID (91):
  • Measurement/testing data - characteristics identified by measuring of user's biophysical or physical parameters.
  • Measurement/testing records storage is a part of Data Repository (35) that persist personalized measurement/testing data for processing, analysis and reporting purposes.
  • Expert System part of Support System (36) based on Artificial Intelligence (AI) technology capable of analysis and diagnostic of measurement data (100) for the purpose of developing best possible strategy of altering user's conditions according to vector of goals, set by administrator (43).
  • AI Artificial Intelligence
  • Fig. 1 is a block diagram of the communicator schema, according to the invention.
  • Fig. 2 is a block diagram of the data flow from communication devices to the patient information management system.
  • Fig. 3 is a block diagram of the practice of the invention using a personal communication device.
  • Fig. 4 is a block diagram of the embedded version of the Communicator technology of the invention into a third party testing /measuring device.
  • Fig. 5 is a block diagram of the patient diagnostic information flow.
  • Fig. 6 is a block diagram of the artificial intelligence matrix.
  • Fig. 7 is a block diagram of the patient information management system.
  • Fig. 8 is a block diagram of outbound information exchanges with the patient information management system.
  • Fig. 9 is a block diagram of the overall flow of information, according to the invention.
  • Fig. 10 depicts the user authentication workflow and processes between the various components of the invention.
  • Fig 1 1 is a depiction of the user diagnostics workflow and processing of information collected from the user to an external support system.
  • Fig. 12 is a depiction of the system user query interface and processes.
  • Fig. 13 is a depiction of the emergency alert trigger workflow and processes.
  • Fig 14 depicts the overall support system structure as it relates to external systems and components integral to, or a part of, PIMS (36)
  • Fig. 15 depicts the overall relationship between PIMS (36) with representative internal functions, a communications network (37) and the Communicator device (24) as a stand alone device.
  • Fig. 16 depicts the overall PIMS (36) system inclusive of an integrated test/measurement device (27) an escalated point of contact component (28) and a clinical alert system and contact center configuration (113), (114) and (123). DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS
  • MCU(I) is a heart of Communicator device (24) as it provides controlling function for all modules, listed in diagram figure 1.
  • MCU (1) establishes communication channel with (19) by wired means (2) or wireless means (3) or (4).
  • Encryption module (5) may or may not be used in data transmission between (24) and (19) depending on capabilities of (19).
  • Communicator device (24) requests measurement data (100) from (19) via created communication channel and (19) transmits data to (24). Then MCU (1) optionally displays request for biometrical data identification of the user (40) via (1 1) and (12) or (9).
  • User provides biometric input for analysis via fingertip scanner (13) or alternative biometric reader (23) (Ex. iris scanner) for further processing by (14).
  • Biometric data (90) is processed by (14) and MCU (1) verifies it against stored user biometric data in MCU internal memory (91). If verification is successful, 100 and 101 will be personalized by global unique user id that Support System (36) recognizes.
  • MCU (1) may request additional infonnation - queries (102), which can be requested by visual means (11) and (12) or audio means (9).
  • User responds to Queries (102) with responses (101) by entering infonnation via (12), (8) or (15). Also additional query response information may be entered via camera (IS).
  • MCU (1) collects geographical position coordinates of (24) via communications module (6) and (17).
  • MCU (1) then process all collected information: GPS coordinates, measurement data(lOO), global unique user id, query responses (101) and packs, encrypts via (5) and transmits data to (36) via (6) + (16) or (21).
  • (6) uses (7) for subscriber identification purposes to register on wireless networks.
  • (24) can not only initiate bi-directional communication with (36) but also accept incoming communication requests from (36).
  • (6) and (21) can also facilitate voice communication with (36) or and (43) via cellular networks or wired networks.
  • Mobile or stationary power source (10) provides power for the entire Communicator Device (24).
  • Fig. 2 depicts the various communications modes and devices (24), (29), (30), (31), (32), (33) capable or enabled to interact with PIMS (36). All communications and information flow are bidirectional between the external devices and the system and are accomplished through a communications network (37). For example, an inbound fax communication is transmitted to the system and read by system via optical character recognition and converted to text (34) as may be required by the system and it's users. Outbound fax communications from system are transmitted in facsimile format to receiving fax machine. Short Message System (SMS) or commonly called Text Messages are both received and transmitted by the system dependent upon parameters defined in the system for a particular user. Voice communications are enabled between a voice device and the system dependent upon parameters and instructions for a particular user.
  • SMS Short Message System
  • Voice communications are enabled between a voice device and the system dependent upon parameters and instructions for a particular user.
  • the Communicator device is enabled to communicate with the system via various means, including but not limited to data and voice dependent on the device configuration for a given user.
  • PIMS performs infonnation analysis (34), data storage (35), supports user interface, interacts with external devices enabled to communicate with the system and responds to information received by the system (34), (35), (36).
  • FIG. 3 depicts the basic design and architecture of the overall system and the path of information flow and communications between an end user measurement/test device(s) and the system. All infonnation flow is bidirectional through and with, all devices and the system.
  • (19) transmits and receives information through (25) and (37) to (36).
  • the information received by (37) is then processed by (34) and/or stored by (35) within (36).
  • Information processed by (36) is then transmitted to (19) via (37) and (25) as may be required.
  • MCU (1) is the core of the communication device technology as it provides the controlling function for all modules, listed in Figure 4.
  • MCU (1) requests measurement data (100) from biophysical/physical measurement module (20) and receives it for further processing. Then MCU (1) optionally displays request for biometrical data identification of the user (40) via (11) and (12) or (9).
  • User provides biometric input for analysis via fingertip scanner (13) or alternative biometric reader (23) (Ex. iris scanner) for further processing by (14).
  • Biometric data (90) is processed by (14) and MCU (1) verifies it against stored user biometric data in MCU internal memory (91). If verification is successful, 100 and 101 will be personalized by global unique user id that Support System (36) recognizes.
  • MCU (1) may request additional information - queries (102), which can be requested by visual means (I I) and (12) or audio means - (9).
  • User responds to Queries (102) with responses (101) by entering information via (12), (8) or (15).
  • additional query response information may be entered via camera (18).
  • MCU (1) collects geographical position coordinates of (24) via communications module (6) and (17). MCU (1) then process all collected information: GPS coordinates, measurement data (100), global unique user id, query responses (101) and packs, encrypts via (5) and transmits data to (36) via (6) + (16) or (21).
  • (6) uses (7) for subscriber identification purposes to register on wireless networks.
  • (24) can not only initiate bi-directional communication with (36) but also accept incoming communication requests from (36).
  • (6) and (21) can also facilitate voice communication with (36) or and (43) via cellular networks or wired networks.
  • Mobile or stationary power source (10) provides power for the entire communication device.
  • FIG. 5 depicts the overall component structure and the interaction between components of PIMS including external devices, ancillary users and communications networks.
  • (40) interacts with (19).
  • (40) may communicate to through (37) to (36) via several means including (24) and (22).
  • (19) communicates to (36) via (24) and (37).
  • (036) communicates to (24), (41), (50) and (51) to initiate and/or confirm processes and actions to be completed.
  • (42) and (43) communicate to (36) via (37) to establish parameters and determine functions to be performed and process information as required by the system users.
  • a system user may utilize (42) and/or (43) to communicate with (50) and/or (51) to via (37) to transfer data or information, establish processes or determine and confirm actions as may be required by system users.
  • Natural Language Processing functionality starts from (61) which is capable of frequency /phase audio signal analysis to determine phonemes. Then (62) generates hypotheses of words and phrases based on phonemes from (61), data from (66) and (67). Further refinement of hypotheses happens when semantic and syntactic analyzer (63) along with (70) based on data from (73) and (74) filters out false hypothesis vs. positive hypothesis. Process of refinement of hypothesis set happens several times until (63) ends up with a single hypothesis with the highest probability to be true. Mistakes in hypotheses can be fixed on further steps of natural language dialog when (71) detects false logic conditions.
  • Automated Decision Support functionality of the system is comprised of the key components: (70), (71), (72), (73) and (74).
  • Predictor/Corrector (71) is module that implements formal and fuzzy logic functionality as well as algorithms of predictability of close and open systems to generate process- controlling steps. (71) generates process controlling steps according to process algorithms from (72) and data from (73) and (74).
  • (70) is module that generates feedback to (71) with analysis what is the result of process controlling steps, generated by (71).
  • DSP (Sl) can be used to preprocess incoming information in form of any digital signals (Ex. video) into the form, understandable by (75).
  • Executor (69) is a component of (75) responsible for assigning jobs and facilitating coherent collaboration between components of (75).
  • Resource management (64) is component that manages system computational and memory resources in (75) to achieve optimal use of them. As long as (75) can be used in mission-critical processes, (68) can be engaged in constant self-monitoring and diagnostics to reduce risks, related to possible malfunctioning of (75) itself, communication infrastructure or other components of the system.
  • Fig. 7 depicts the various communications modes and devices capable or enabled to interact with PIMS in a detailed block diagram including the internal structure of PIMS modules to interface and interact with other systems, components and networks. All communications and information flow are bidirectional between the external devices and the system and are accomplished through a communications network (37). Wherein (40) may communicate with (36) via any or all of several means including (19), (24), (30), (31), (32), and (33) to (36) via (37). For example, an inbound, fax communication is transmitted to the system via (30) and read by system via optical character recognition and converted to text as may be required by the system and its users. Outbound fax communications from system are transmitted in facsimile format to receiving fax machine.
  • (40) may utilize (31) to communicate via Short Message System (SMS) or commonly called Text Messages are both received and transmitted by the system dependent upon parameters defined in the system for a particular user.
  • SMS Short Message System
  • Voice communications (33) are enabled between a voice device and the system (36) dependent upon parameters and instructions for a particular user.
  • the Communicator device (24) is enabled to communicate with the system (36) via various means, including but not limited to data and voice dependent on the device configuration for a given user.
  • PIMS performs information analysis, data storage, supports user interface, interacts with external devices enabled to communicate with the system and responds to information received by the system.
  • the internal structures of (36) control interface with (40) via (78), (79) and (80) and (42) via (76). Elements (35), (75) and (77) control processes within (36).
  • FIG. 8 depicts an overall view of basic interaction operations and capabilities between (40) and (19) and (36) and (43) depending on the system configuration and user requirements.
  • (40) may establish bidirectional communications with (43) via (37).
  • (43) has access to (36) via (42) to establish parameters, determine functions and control information flow. Depiction of information and data flow path between (40) via (19) and (24) through (37) to (36).
  • FIG. 9 depicts the various configurations and communications modalities that may be utilized by (40) to transmit and receive data and information to and from (36) and (43) via (19), (24), (33), (44), (45), (46), (47) and (37).
  • data is transmitted, to (24) and depending on requirements and configurations determined by the users of the system, may further transmit data and information to (36) via any one, all, or a combination of the available communications modes depicted by (44), (45), (46), (47), or (33).
  • (40) utilizes (19) to test for specific biophysical information.
  • the information collect by (19) is then transmitted to (24) where upon (24) transmits the data or information to (36) via (37) utilizing the functions of (44).
  • Element (43) is utilized by system authorized users to accesses (36) to view, establish and retrieve information as well as establish parameters, determine threshold events, configure control functions and verify data and information contained within (36) and determine actions to be taken by (36) upon receipt of information and data from (40).
  • user authentication workflow starts from user (40) providing biometric identification reading (90).
  • Communicator compares (90) with all user data profiles, stored in (91). If user profile matched, authentication process completes at this step. If user profile did not match, communicator (24) establishes secure communication with support system (36) via (37). (24) then transmits (90) to support system (36) in order to lookup whether user profile already exists in (35). If user profile is found, then (36) either reuses existing communication channel or establishes new secure communication channel (96) via (37) and transmits global unique user id along with cryptographic hash of (90) to communicator.
  • Communicator then launches synchronization process (92) that associates biometric reading (90) with global user id with the help of hash and authentication process completes at this step. If user profile was not found in (35) then new user registration workflow starts. (36) generates new global unique user id (95), notifies administrator (43) which establishes new user account (98). After account was established, system persists data (97) to (35), establishes new secure communication channel (96) via (37) with (24) or reuses existing channel. Communicator then launches synchronization process (92) that associates biometric reading (90) with global user id with the help of hash and authentication process completes at this step. If connection to communicator cannot be established immediately system waits and retries.
  • user diagnostic workflow starts from communicator (24) collecting biometric data (90), Measurement /testing data(lOO) and user queries answers (101).
  • (100) and (101) can be personalized with global unique user id by means of (90) and sent via communications network (37) to support system (36).
  • (36) can receive information (103), decrypt, preprocess it and store in (104) .
  • (103) also can send data to expert system (106) that in conjunction with (107) can process and analyze current, historical data according to algorithms identified by administrator(43).
  • system can trigger addition queries(102) to communicator device to inquiry more information from the user that will be delivered back to the system from communicator(24) via (37).
  • FIG. 12 depicts the overall query interface and function of the PIMS as combined with the embedded technology of the Communicator.
  • the query function is designed to act upon information received from (100) via (109) and (37) in to (106).
  • (106) conducts analysis on the information combined with information from (35) to determine query requirements, if any. If there is further action required, as determined, by the users of the system and parameters set forth therein, (106) will then transmit a request to (109) via (37) for (102) to generate the appropriate query and display same on the Communicator display for response by the Communicator user.
  • element (102) may have predetermined queries to be displayed on the Communicator for the user as determined by the authorized system users.
  • (106) may generate custom queries not previously programmed or loaded into (102) as further analysis of information received is completed requiring more information from the user via (100) such as retesting and re-transmitting test data to confirm previous information received or generate new information in the event of an initial errant data or information transmission. For example: An initial test from (100) transmits data to (106) that is not within established parameters for the user, the system then generates a query transmitted back to the user to re-test to confirm initial data or to transmit correct data due to a failed initial data transmission. In the event the initial data is confirmed. The system will then proceed with actions as determined by authorized system users and actions to be taken such a generating an alert or contacting third party personnel or entities as may be the case.
  • FIG. 13 depicts the overall functional operation of the emergency alert function (111) of the Communicator device.
  • (111) can be a keypad entry, power button or otherwise dedicated button/function on the device that when pressed in a specific manner or for a specific amount of time (such as "press and hold"), can be utilized by the user to summon emergency aid or services via (1 10), with user information and location data obtained from (112) through (37) to the system (36) wherein the information is processed by (104) and (113) as determined by parameters, instructions and configurations established by (43) with the resultant action being the transmission of end user information via (37) to (114).
  • (115) may be utilized by the Communicator user to transmit an alert situation or status directly to (36) via (37), to initialize the same processes as an alert generated by (111).
  • the system can transmit Communicator user information to ( 1 14) containing or based on information contained in (104).
  • the system (36) receives an auto-generated alert from the Communicator via (110) and (96) with data from (112).
  • (36) Upon confirmation of the information, (36), based on parameters set by (43), can provide information from (104) via (1 13) and (37) to be transmitted or passed to responding personnel.
  • FIG. 14 depicts the overall support system structure as it relates to external systems and components integral to, or a part of, PIMS (36). All communications between PIMS and external devices and systems are bidirectional via (37).
  • the system architecture allows for multiple actions to be completed or initiated by the data and information received by the system. For Example: When the system receives biophysical information from a patient via (24) and (37), it initiates a process whereby the information is provided to the Point of Care for review. Further action may be taken to verify review of the information and bill for same to an insurance earner and/or Medicare (38). Theses actions may also include the issuance of a new prescription (50). Additionally, dependent upon the parameters set by the authorized system users, if out of parameter info ⁇ nation is received and verified to be accurate (106), the clinical alert notification (114) and action process (113), (123)is initiated.
  • FIG. 15 depicts the overall relationship between PIMS (36) with representative internal functions, a communications network (37) and the Communicator device (24) as a stand alone device. Inter-relationship of the internal components of PIMS are further represented in Figure's 6 and 7.
  • FIG 16 depicts the overall PIMS (36) system inclusive of an integrated test/measurement device (27) an escalated point of contact component (2S) and a clinical alert system and contact center configuration (113), (114) and (123).
  • (27) represents an integrated test/measurement device (27) having the Communicator technology (Fig. 4) embedded in the device.

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Abstract

L'invention concerne un système de gestion et d’analyse d’informations et de génération de réponses, utilisé avec des dispositifs de surveillance en vue de tests et d’une surveillance à distance de paramètres physiologiques d’utilisateurs du système (par ex. tests liés au diabète, test de tension artérielle, anti-coagulation, etc.). Le système de gestion et d’analyse d’informations et de génération de réponses permet à des dispositifs de test et de surveillance fabriqués par des entreprises tierces de communiquer avec le système via des moyens existants de communication en réseau fonctionnant sous une technologie propriétaire. Suite à l’analyse des données recueillies, le système est capable d’amorcer des communications avec des tiers, notamment des notifications interactives d’alertes cliniques.
PCT/IB2009/006821 2008-09-13 2009-09-15 Dispositif et système de test et de montage WO2010029427A1 (fr)

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US22521109P 2009-07-14 2009-07-14
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US55857709A 2009-09-13 2009-09-13
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