WO2018044894A1 - Systèmes, dispositifs et procédés connectés de surveillance de traitements cliniques - Google Patents

Systèmes, dispositifs et procédés connectés de surveillance de traitements cliniques Download PDF

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Publication number
WO2018044894A1
WO2018044894A1 PCT/US2017/049127 US2017049127W WO2018044894A1 WO 2018044894 A1 WO2018044894 A1 WO 2018044894A1 US 2017049127 W US2017049127 W US 2017049127W WO 2018044894 A1 WO2018044894 A1 WO 2018044894A1
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WO
WIPO (PCT)
Prior art keywords
information
user
clinical
quality
life
Prior art date
Application number
PCT/US2017/049127
Other languages
English (en)
Inventor
James C. Chen
Llew Keltner
Alexei N. Naimushin
Original Assignee
Chen James C
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Chen James C filed Critical Chen James C
Publication of WO2018044894A1 publication Critical patent/WO2018044894A1/fr

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Classifications

    • 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
    • A61B5/1118—Determining activity level
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/486—Bio-feedback
    • 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
    • A61B5/7475—User input or interface means, e.g. keyboard, pointing device, joystick
    • A61B5/749—Voice-controlled interfaces
    • 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
    • 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
    • A61B5/0077—Devices for viewing the surface of the body, e.g. camera, magnifying lens
    • 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
    • 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
    • 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
    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02416—Detecting, measuring or recording pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation
    • 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 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/0816—Measuring devices for examining respiratory frequency

Definitions

  • the present disclosure is directed to, among other things, a system comprising circuitry configured to exchange clinical information about a user.
  • the system includes circuitry configured to generate quality-of-life information based at least in part on the clinical information about a user.
  • the system includes circuitry configured to exchange physiological information with a remote client device, and circuitry configured to generate quality-of- life information based at least in part on the clinical information about the user and the physiological information.
  • the present disclosure is directed to, among other things, a method comprising receiving clinical information about a user.
  • receiving clinical information about a user includes receiving at least one of disease free survival information, duration of response information, event free survival information, number needed to treat (NNT) information, overall response rate information, overall survival information, median overall survival information, progression free survival information, time to next treatment information, time to progression information, time to treatment failure information.
  • the method includes receiving physiological information from a physiological sensor of wearable device of the user.
  • the method includes determining quality-of-life information based at least in part on the clinical information and the physiological information about the user.
  • the present disclosure is directed to, among other things, a clinical trial device.
  • the clinical trial device includes means for receiving clinical information and physiological information about a user.
  • the clinical trial device includes means for determining quality-of-life information based at least in part on the clinical information and the physiological information about the user.
  • the clinical trial device includes means for anonymizing, encrypting, and transmitting quality-of-life information.
  • FIGURE 1 is a perspective view of a system according to one embodiment.
  • FIGURE 2 is a perspective view of a system according to one embodiment.
  • FIGURES 3A-3D show a flow diagram of a method according to one embodiment.
  • a system 100 includes circuitry 102 configured to exchange clinical information about a user.
  • clinically endpoint information include disease free survival information, duration of response, event free survival information, number needed to treat (NNT), overall response rate, overall survival information and median overall survival information, progression free survival information, time to next treatment, time to progression, time to treatment failure, and the like.
  • the system 100 includes circuitry 104 configured to generate quality-of-life information based at least in part on the clinical information about a user.
  • circuitry 104 configured to generate quality-of-life information is operably coupled to a sensor array including computing device circuitry and memory circuitry, and is configured to generate quality-of-life information about the user responsive to one or more inputs from the sensor array.
  • circuitry includes, among other things, one or more computing devices such as a processor (e.g., a microprocessor), a central processing unit (CPU), a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field programmable gate array (FPGA), or the like, or any combinations thereof, and can include discrete digital or analog circuit elements or electronics, or combinations thereof.
  • a processor e.g., a microprocessor
  • CPU central processing unit
  • DSP digital signal processor
  • ASIC application-specific integrated circuit
  • FPGA field programmable gate array
  • circuitry includes one or more ASICs having a plurality of predefined logic components.
  • circuitry includes one or more FPGA having a plurality of programmable logic components.
  • circuitry includes one or more sensors, detectors, transducers, and the like.
  • Non-limiting examples of sensors include acoustic sensors, optical sensors, electromagnetic energy sensors, image sensors, photodiode arrays, charge-coupled devices (CCDs), complementary metal-oxide- semiconductor (CMOS) devices, transducers, optical recognition sensors, infrared sensors, radio frequency components sensors, thermo sensors, or the like.
  • the medical device 802 includes circuitry having one or more components operably coupled (e.g., communicatively, electromagnetically, magnetically, ultrasonically, optically, inductively, electrically, capacitively coupled, or the like) to each other.
  • circuitry includes one or more remotely located components.
  • remotely located components are operably coupled via wireless communication.
  • remotely located components are operably coupled via one or more receivers, transceivers, or transmitters, or the like.
  • circuitry includes one or more memory devices that, for example, store instructions or data.
  • the medical device 802 includes one or more memory devices that store one or more parameters for orienting and optical stimulus, for locating a needle within a biological subject, for delivering photodynamic therapy, and the like.
  • Non-limiting examples of one or more memory devices include volatile memory (e.g., Random Access Memory (RAM), Dynamic Random Access Memory (DRAM), or the like), non-volatile memory (e.g., Read-Only Memory (ROM), Electrically Erasable Programmable Read-Only Memory (EEPROM), Compact Disc Read-Only Memory (CD-ROM), or the like), persistent memory, or the like.
  • volatile memory e.g., Random Access Memory (RAM), Dynamic Random Access Memory (DRAM), or the like
  • non-volatile memory e.g., Read-Only Memory (ROM), Electrically Erasable Programmable Read-Only Memory (EEPROM), Compact Disc Read-Only Memory (CD-ROM), or the like
  • one or more memory devices include Erasable Programmable Read-Only Memory (EPROM), flash memory, or the like.
  • EPROM Erasable Programmable Read-Only Memory
  • the one or more memory devices can be coupled to, for example, one or more computing devices by one or more instructions, data, or power buses.
  • circuitry includes one or more computer-readable media drives, interface sockets, Universal Serial Bus (USB) ports, memory card slots, or the like, and one or more input/output components such as, for example, a graphical user interface, a display, a keyboard, a keypad, a trackball, a joystick, a touch-screen, a mouse, a switch, a dial, or the like, and any other peripheral device.
  • circuitry includes one or more user input/output components that are operably coupled to at least one computing device to control (electrical, electromechanical, software-implemented, firmware-implemented, or other control, or combinations thereof) at least one parameter associated with, for example, delivering photodynamic therapy.
  • circuitry includes a computer-readable media drive or memory slot that is configured to accept signal-bearing medium (e.g., computer-readable memory media, computer-readable recording media, or the like).
  • signal-bearing medium e.g., computer-readable memory media, computer-readable recording media, or the like.
  • a program for causing a system to execute any of the disclosed methods can be stored on, for example, a computer-readable recording medium (CRMM), a signal-bearing medium, or the like.
  • CRMM computer-readable recording medium
  • Non-limiting examples of signal-bearing media include a recordable type medium such as a magnetic tape, floppy disk, a hard disk drive, a Compact Disc (CD), a Digital Video Disk (DVD), Blu-Ray Disc, a digital tape, a computer memory, or the like, as well as transmission type medium such as a digital and/or an analog communication medium (e.g., a fiber optic cable, a waveguide, a wired communications link, a wireless communication link (e.g., receiver, transceiver, or transmitter, transmission logic, reception logic, etc.).
  • a recordable type medium such as a magnetic tape, floppy disk, a hard disk drive, a Compact Disc (CD), a Digital Video Disk (DVD), Blu-Ray Disc, a digital tape, a computer memory, or the like
  • transmission type medium such as a digital and/or an analog communication medium (e.g., a fiber optic cable, a waveguide, a wired communications link, a wireless communication
  • signal-bearing media include, but are not limited to, DVD-ROM, DVD-RAM, DVD+RW, DVD-RW, DVD-R, DVD+R, CD-ROM, Super Audio CD, CD-R, CD+R, CD+RW, CD-RW, Video Compact Discs, Super Video Discs, flash memory, magnetic tape, magneto-optic disk, MINIDISC, nonvolatile memory card, EEPROM, optical disk, optical storage, RAM, ROM, system memory, web server, or the like.
  • circuitry includes computing circuitry, memory circuitry, electrical circuitry, electro-mechanical circuity, control circuitry, transceiver circuitry, transmitter circuitry, receiver circuitry, and the like.
  • the circuitry 104 configured to generate quality-of-life information includes computing device circuitry, memory circuitry, and at least one of transceiver circuitry, transmitter circuitry, and receiver circuitry.
  • the system 100 includes circuitry 106 configured to exchange physiological information with a remote client device.
  • the circuitry 106 configured to exchange physiological information with a remote client device is operably coupled to one or more sensors.
  • the circuitry 106 configured to exchange physiological information with a remote client device is operably coupled to one or more physiological sensors.
  • the system includes one or more sensors configured to acquire physiological information about a biological subject.
  • the system includes one or more one-, two-, or three- dimensional sensor arrays.
  • Non-limiting examples of sensors include biosensors, blood volume pulse sensors, cameras, conductance sensors, detectors, differential calorimeter sensors, electrochemical sensors, fluorescence sensors, force sensors, high resolution temperature sensors, image sensors optical sensors, physiological sensors, potentiometer sensors, refractive index detectors, resistance sensors, respiration sensors, sound sensors (e.g., acoustic transducers and the like), surface Plasmon band gap sensor (SPRBG), surface Plasmon sensors, temperature sensors (e.g., thermistors, thermocouples, thermometers, infrared sensors, and the like), ultrasound), and the like.
  • SPRBG surface Plasmon band gap sensor
  • sensors include affinity sensors, bioprobes, biostatistics sensors, cavitand-based supramolecular sensors, chemical sensors, deoxyribonucleic acid sensors (e.g., electrochemical DNA sensors and the like), enzymatic sensors, in-situ sensors (e.g., in-situ chemical sensors and the like), ion sensors, light sensors (e.g., visible light sensors, ultraviolet sensors, infrared sensors, optical sensors, and the like), microbiological sensors, microhotplate sensors, micron- scale moisture sensors, nanosensors, optical chemical sensors, pH sensors, single particle sensors, supramolecular sensors, three-dimensional sensors (e.g., 3-D sensors operable to capture information about the shape of a structural features of a biomass, tumor, growth, and the like), and the like.
  • light sensors e.g., visible light sensors, ultraviolet sensors, infrared sensors, optical sensors, and the like
  • microbiological sensors e.g., microhotplate sensors, micron- scale moisture sensors, nanosensors, optical
  • sensors include acoustic transducers, capacitance sensors, contact sensors, dielectric sensors, fiber optic sensors, flexure sensors, image sensors, impedance sensors, infrared sensors, nodes, object sensors, optical sensors, pressure sensors, topographic feature sensors, transducers, ultrasonic transducers, and the like.
  • sensors include accelerometers, cameras, geographical sensor, goniometry sensors, gyroscopes, inertial navigation sensors, inertial sensors, location sensor, motion sensors, movement sensors, orientation sensors, position sensors, radiofrequency sensors, tracking sensors, and the like.
  • data is captured by way of a wide variety of means ranging from photos and videos to radiographic images and lab data, by various individuals involved with patient care such as clinician and treatment related staff, including treating physicians, including but not limited to medical oncologists, radiation oncologists, surgeons, interventionalists, radiologists, primary care physicians, nurses, physician assistants, and other clinical care personnel.
  • treating physicians including but not limited to medical oncologists, radiation oncologists, surgeons, interventionalists, radiologists, primary care physicians, nurses, physician assistants, and other clinical care personnel.
  • the system 100 includes at least one of a complementary metal-oxide-semiconductor (CMOS) image sensor, a variable-integration-time image sensor, a time-integrating optical component, a linear time-integrating component, a nonlinear optical component, a temporal autocorrelation component, a variable- integration-time image sensor component, and the like.
  • CMOS complementary metal-oxide-semiconductor
  • the system 100 includes circuitry 104 configured to generate quality-of-life information based at least in part on the clinical information about the user and the physiological information.
  • the circuitry 104 configured to generate quality-of-life information based at least in part on the clinical information about a user includes health state circuitry configured to generate user health state information based at least in part on the clinical information about the user and the physiological information.
  • the system 100 includes one or more sensors configured to acquire biometric information about a biological subject.
  • the system 100 includes circuitry 108 configured to exchange biometric information with a remote client device, and circuitry 104 configured to generate quality-of-life information based at least in part on the clinical information about the user and the biometric information.
  • the circuitry 108 configured to exchange biometric information with a remote client device is operably coupled to one or more biometric sensor. In an embodiment, the circuitry 108 configured to exchange biometric information with a remote client device is operably coupled to one or more nodes. In an embodiment, the circuitry 108 configured to exchange biometric information with a remote client device includes computing device circuitry, memory circuitry, and at least one of transceiver circuitry, transmitter circuitry, and receiver circuitry.
  • the system 100 includes circuitry configured 110 to exchange treatment session information with a remote client device, and circuitry 104 configured to generate quality-of-life information based at least in part on the clinical information about the user and the treatment session information.
  • the system 100 includes circuitry 112 configured to exchange photoactivation treatment information, the photoactivation treatment information including at least one of the total photoactivation treatment time, light intensity, fluence rate, and total joules of energy dose, treatment session information with a remote client device, and circuitry 104 configured to generate quality-of-life information based at least in part on the clinical information about the user and the photoactivation treatment information.
  • the system 100 includes circuitry 114 configured to anonymize quality-of-life information prior to transmitting.
  • the system 100 includes circuitry 116 configured to encrypt quality-of-life information prior to transmitting.
  • the system 100 includes circuitry 118 configured to generate reimbursement information based at least in part on the clinical information about a user.
  • the system 100 includes circuitry 120 configured to generate indirect/direct cost information based at least in part on the clinical information about a user.
  • the system 100 includes circuitry 122 configured to generate decision tree information based at least in part on the clinical information about a user.
  • the system 100 includes circuitry 124 configured to generate treatment regimen information based at least in part on the clinical information about a user.
  • the system 100 includes circuitry 126 configured to transmit, anonymized, and encrypted clinical information.
  • system 100 includes circuitry 128 configured to enable optical character recognition (OCR) for electronic conversion of images of typed, handwritten, printed text, and the like into machine-encoded text.
  • system 100 includes circuitry 130 configured to capture verbal data, recorded data, written data, and the like.
  • patient and healthcare professional feedback is captured in an access restricted, encrypted format, which can be HIPAA (Health Insurance Portability and Accountability Act) compliant in order to preserve privacy.
  • HIPAA Health Insurance Portability and Accountability Act
  • voice to text conversion technology known in the art is used to convert the data into a format, which enables proper analysis.
  • use of a verbal format may be less fatiguing for the patient, more accurate, enable data capture at more time points, and in a more comprehensive manner, be more convenient for the patient, and is a novel means of patient data gathering.
  • the formats and data content captured can be suitable for registration studies, label expansion, for marketing, presentations, medical and scientific papers, and for the treating clinicians and healthcare personnel communication to the patient and family/significant others.
  • patient adherence / experience regarding special instructions, overall compliance, and the global experience is optionally captured for analysis as well.
  • system 100 is operable to capture information regarding the planning, execution of therapy, outcome, and therapeutic implementation. In an embodiment, the system 100 is operable to preserve, analyze the information to help guide further research and development.
  • data anonymize and encrypting to preserve confidentiality and for security.
  • identification of surrogate endpoints is facilitated by analysis of biomarkers, events, and ultimate patient outcomes.
  • identification of surrogate endpoints facilitates the approval process as well as for prognostication.
  • data is optionally captured by a cloud based format, which facilitates data input from a variety of global locations, and by treatment centers of various types.
  • a standardized format can be created for data capture, to aid in analysis for clinical, regulatory, reimbursement, and insurance purposes, as well as for economic analysis as it pertains to the patient, the treating clinicians, the treatment facility or institution, and the insurers.
  • cost benefit analysis can be a part of the analysis of the "success" of the therapy, and the side effect profile can be carefully documented, with the goal of reducing side effects to a minimum.
  • patient specific information includes diet information, exercise status, sleep habits and quality, nutritional status, supplement usage, general lifestyle of the patient, and the premorbid conditions, if any are also optionally captured by the system 100 for incorporation into outcomes analysis using multiple variables.
  • patient specific information includes data regarding premorbid conditions, biometric data, biomarkers and biomarker changes, inflammation status and evolution, therapeutic outcomes, and other combination treatments, and subsequent treatments, which may affect survival, help the goal of reducing confounders in terms of clinical trials.
  • FIGURE 2 shows a clinical trial device 202 for implementing one or more methodologies or technologies for monitoring cancer immunotherapy clinical treatments.
  • the clinical trial device 202 comprises one or more of a client device, a computer device, a connected device, a desktop computer device, a laptop computer device, a notebook computer device, a managed node device, a mobile device, a remote controller, a smartphone device, a tablet device, and the like.
  • a clinical trial device 202 comprises one of a wearable device, a wearable health monitor device, and an application interface with a smart device.
  • the system 100 includes one or more components configured to capture of metrics and quality measures associated with reimbursement / regulatory requirements. In an embodiment, the system 100 includes one or more components configured to capture subjective and objective experiences of the healthcare providers and the patients. In an embodiment, the system 100 integrates economic data, including direct and indirect costs of therapy, side effect data, quality of life data, various outcome measures, and the clinician implementation experience to enable a new type of evaluation which incorporates and amalgamates quality related parameters with the actual patient and clinician experience.
  • the system 100 includes at least of a client device, a computer device, a connected device, a desktop computer device, a laptop computer device, a notebook computer device, a managed node device, a mobile device, a remote controller, a smartphone device, a tablet device, and the like.
  • the system 100 includes at least of a wearable device, a wearable health monitor device, and an application interface with a smart device, and the like
  • the clinical trial device 202 includes means 204 for receiving clinical information and physiological information about a user.
  • means 204 for receiving clinical information and physiological information about a user includes circuitry having one or more modules optionally operable for communication with one or more input/output components that are configured to relay user output and/or input.
  • a module includes one or more instances of electrical, electromechanical, software-implemented, firmware-implemented, or other control devices. Such devices include one or more instances of memory; computing devices; antennas; power or other supplies; logic modules or other signaling modules; gauges or other such active or passive detection components; piezoelectric transducers, shape memory elements, micro-electro-mechanical system (MEMS) elements, or other actuators.
  • means 204 for receiving clinical information and physiological information about a user includes one or more of transceiver circuitry, transmitter circuitry, and receiver circuitry.
  • a clinical trial device 202 includes means 206 for determining quality-of-life information based at least in part on the clinical information and the physiological information about the user.
  • the means 206 for determining quality-of-life information includes circuitry configured to detect (e.g., assess, calculate, evaluate, determine, gauge, measure, monitor, quantify, resolve, sense, or the like) quality-of-life information.
  • a clinical trial device 202 includes means 208 for anonymizing, encrypting, and transmitting quality-of-life information.
  • means 208 for anonymizing, encrypting, and transmitting quality-of-life information includes circuitry configured to anonymize, encrypt, and transmit quality-of- life information.
  • a clinical trial device 202 includes means 210 for exchanging anonymized and encrypted information associated with at least one of the clinical information about the user, the physiological information, and quality-of-life information with a remote network.
  • means 210 for exchanging anonymized and encrypted information includes a communication module having circuitry configured to negotiate at least one of the clinical information about the user, the physiological information, and quality-of-life information based on at least one cryptographic protocol, encryption protocol, or decryption protocol.
  • means 210 for exchanging anonymized and encrypted information includes a communication module operably coupled to a speech recognition module that causes a communication module associated with the clinical trial device 202 to change between a transmit states and a receive state responsive to one or more audio inputs.
  • means 210 for exchanging anonymized and encrypted information includes a communication module having one or more antennas, receivers, transmitters, transceivers, and the like operable to communicate with a remote enterprise and to receive information from the remote enterprise.
  • a clinical trial device 202 takes the form of a wearable device including one or more mobile applications, cloud applications, client applications, and the like monitors and processes vital health parameters, physiological parameters, physical activities, and the like.
  • a mobile device iOS, Android, Windows, and the like
  • wireless communication protocol such as BLE (Bluetooth Low Energy) which is further connected to the cloud.
  • a clinical trial device 202 accesses a service made available by a server.
  • a client device accesses the service by way of a network.
  • the clinical trial device 202 includes a Wi-Fi networking card.
  • a client device is operable to connect to the Internet and exchange services, information, and the like.
  • the clinical trial device 202 is operable to retrieve data from one or more remote sensors.
  • the clinical trial device 202 is operable to retrieve data from a GPS-capable device.
  • FIGURE 3 shows method 300.
  • the method 300 includes receiving clinical information about a user, the clinical information including at least one of disease free survival information, duration of response information, event free survival information, number needed to treat (NNT) information, overall response rate information, overall survival information, median overall survival information, progression free survival information, time to next treatment information, time to progression information, time to treatment failure information.
  • NNT number needed to treat
  • the method 300 includes receiving physiological information from a physiological sensor of wearable device of the user.
  • the method 300 includes determining quality-of-life information based at least in part on the clinical information and the physiological information about the user.
  • determining quality-of-life information includes determining quality-of- life information based at least in part on the clinical information, the physiological information about the user, and the photoactivation treatment information.
  • the method 300 includes receiving biometric information from a biometric sensor of wearable device of the user.
  • receiving the physiological information from the physiological sensor of the wearable device of the user includes receiving at least one of premorbid condition marker information, biomarker information, change in a biomarker information, and inflammation status information.
  • the method 300 includes determining quality-of-life information based at least in part on the clinical information and the biometric information about the user.
  • the method 300 includes presenting the quality-of-life information via at least one of a visual display device of the wearable device, a haptic device of the wearable device, and an audio output device of the wearable device.
  • the method 300 includes presenting the quality-of-life information, via one or more output devices, directing the user to alter therapy.
  • the method 300 includes anonymizing and encrypting at least one of the clinical information about the user, the physiological information, and quality-of-life information prior to transmitting the at least one of the clinical information about the user, the physiological information, and quality-of-life information.
  • the method 300 includes exchanging anonymized and encrypted information associated with at least one of the clinical information about the user, the physiological information, and quality-of-life information with a remote network.
  • the method 300 includes exchanging at least one of the clinical information about the user, the physiological information, and quality-of-life information with a client device.
  • the method 300 includes generating Health Insurance Portability and Accountability Act of 1996 (HIPAA)-compliant clinical information about the user.
  • HIPAA Health Insurance Portability and Accountability Act of 1996
  • the method 300 includes exchanging photoactivation treatment information, the photoactivation treatment information including at least one of the total photoactivation treatment time, light intensity, fluence rate, and total joules of energy dose.
  • the method 300 includes exchanging user-specific health information, the user-specific health information including at least one of the diet, exercise status, sleep habit information, quality of sleep information, nutritional status information, supplement usage information, general lifestyle information, and premorbid condition information.
  • the method 300 includes determining quality-of-life information based at least in part on the clinical information, the physiological information about the user, and the user-specific health information.
  • the method 300 includes generating reimbursement information based on at least one of the physiological information and the quality-of-life information.
  • the method 300 includes generating regulatory requirement information based on at least one of the physiological information and the quality-of-life information.
  • the method 300 includes generating therapy comparison information based on at least one of the physiological information and the quality-of-life information.
  • the method 300 includes generating an alternative therapy protocol based on at least one of the physiological information and the quality-of-life information.
  • the method 300 includes generating survivorship information based on at least one of the physiological information and the quality-of-life information.
  • the method 300 includes determining a therapeutic change based on at least one of the physiological information and the quality-of-life information.
  • the method 300 includes evaluating a therapeutic protocol, regimen, or treatment based on at least one of the physiological information and the quality-of-life information.
  • the method 300 includes capturing clinical trial information.
  • capturing clinical trial information includes receiving one or more audio inputs associated cancer diagnostic information.
  • capturing clinical trial information includes receiving one or more audio inputs associated with at least one of a laboratory result, execution of therapy information, procedure compliance information, delivery of care information, and treatment administration information.
  • capturing clinical trial information includes receiving data representing one or more of medical images, laboratory data, procedure compliance information, and therapeutic implementation information.
  • capturing clinical trial information includes receiving data obtained by a microphone array coupled to the wearable device.
  • the method 300 includes generating reimbursement information based at least in part on the clinical information about the user.
  • the method 300 includes generating indirect/direct cost information based at least in part on the clinical information about the user.
  • the method 300 includes generating decision tree information based at least in part on the clinical information about the user.
  • the method 300 includes generating treatment regimen information based at least in part on the clinical information about the user.
  • the device captures clinically endpoint information.
  • clinically endpoint information include disease free survival information, duration of response, event free survival information, number needed to treat (NNT), overall response rate, overall survival information and median overall survival information, progression free survival information, time to next treatment, time to progression, time to treatment failure, and the like.
  • clinically endpoint information includes light intensity or fluence rate, total treatment time, total joules of energy delivered, and the like.
  • clinically endpoint information includes real time video, still images, and sound can be captured by system 100.
  • treatment session data is uploaded to a separate mobile or non- mobile device linked to the internet, which may include a cloud type service.
  • a clinician or staff also similarly enters the tumor volume, location, symptoms and signs caused by the tumor if any, and the therapy response including biomarker response at multiple time points.
  • imaging and lab data are similarly captured.
  • patient and even family specific quality of life and treatment experience and physical data is likewise captured in the same manner.
  • clinician or staff related treatment experience data also captured in the same manner.
  • the total and detailed patient, family, clinician, and staff related experience is captured for analysis in a novel manner not currently performed in standard oncology trials.
  • the data base can be utilized for any number of purposes, ranging from facilitating the drug and device approval process, to expansion of the approval label, to facilitating reimbursement, and guiding further therapeutic improvements relating to treatment methodology, and drug and device improvements.
  • the data captured can be used to develop and refine survivorship planning.
  • specific patient immunologic parameters are captured.
  • Non- limiting examples of specific patient immunologic parameters including markers of inflammation are also captured and analyzed, in order to optimize each therapy session. Delayed type hypersensitivity testing can be a surrogate immune response test incorporated into the immune response assessment algorithm as well.
  • a treatment algorithm can be evolved which equates the total tumor volume treated and immune and tumor response.
  • the data captured and analyzed also can incorporate additional therapy without limitation, such as surgery, radiation, ablative therapies, chemotherapy, targeted drugs, antibody therapy, drug immunotherapy, and other procedures and ancillary treatments and interventions, including lifestyle changes.
  • Treatment algorithms which incorporate all different types of procedures, interventions, surgery, systemic and localized drug therapy of all types can be developed and refined as greater numbers of patients are treated.
  • treatment guidelines, decision trees, and automated recommendations based on analysis of a growing database are generated.
  • regulations, legal requirements, quality measures, and other stipulated requirements and measures are satisfied by the global data capture and analysis techniques and measures.
  • the system is protected by encryption to comply with standard privacy requirements, and to protect the data from theft.
  • data sets may be proprietary as well, and the data can be parsed into public, reportable, and private as well as proprietary data sets.
  • any two components so associated can also be viewed as being “operably connected”, or “operably coupled,” to each other to achieve the desired functionality, and any two components capable of being so associated can also be viewed as being “operably coupleable,” to each other to achieve the desired functionality.
  • operably coupleable include, but are not limited to, physically mateable, physically interacting components, wirelessly interactable, wirelessly interacting components, logically interacting, logically interactable components, etc.
  • one or more components may be referred to herein as “configured to,” “configurable to,” “operable/operative to,” “adapted/adaptable,” “able to,” “conformable/conformed to,” etc.
  • Such terms can generally encompass active-state components, or inactive-state components, or standby-state components, unless context requires otherwise.
  • ASICs Application Specific Integrated Circuits
  • FPGAs Field Programmable Gate Arrays
  • DSPs digital signal processors
  • some aspects of the embodiments disclosed herein, in whole or in part, can be equivalently implemented in integrated circuits, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as virtually any combination thereof, and that designing the circuitry or writing the code for the software and or firmware would be well within the skill of one of skill in the art in light of this disclosure.
  • Non-limiting examples of a signal-bearing medium include the following: a recordable type medium such as a floppy disk, a hard disk drive, a Compact Disc (CD), a Digital Video Disk (DVD), a digital tape, a computer memory, etc.; and a transmission type medium such as a digital or an analog communication medium (e.g., a fiber optic cable, a waveguide, a wired communications link, a wireless communication link (e.g., transmitter, receiver, transmission logic, reception logic, etc.), etc.).
  • a recordable type medium such as a floppy disk, a hard disk drive, a Compact Disc (CD), a Digital Video Disk (DVD), a digital tape, a computer memory, etc.
  • a transmission type medium such as a digital or an analog communication medium (e.g., a fiber optic cable, a waveguide, a wired communications link, a wireless communication link (e.g., transmitter, receiver, transmission logic, reception logic, etc.),

Abstract

La présente invention concerne des systèmes, des dispositifs et des procédés notamment destinés à fournir des améliorations dans le traitement de tissus anormaux y compris du cancer, au moyen d'une thérapie médicamenteuse activée par la lumière. Des améliorations comprennent des méthodologies et des technologies de surveillance des traitements cliniques d'immunothérapie anticancéreuse, d'analyse de résultats cliniques, d'amélioration de l'expérience du patient, et équivalents. Dans un mode de réalisation, un système comprend des circuits configurés pour échanger des informations cliniques relatives à un utilisateur, et un circuit configuré pour générer des informations de qualité de vie au moins en partie sur la base d'informations cliniques relatives à un utilisateur.
PCT/US2017/049127 2016-08-29 2017-08-29 Systèmes, dispositifs et procédés connectés de surveillance de traitements cliniques WO2018044894A1 (fr)

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