EP2967357A1 - Surveillance d'une réponse hémodynamique cérébrale en temps réel (srhctr) d'un sujet basée sur des paramètres hémodynamiques - Google Patents

Surveillance d'une réponse hémodynamique cérébrale en temps réel (srhctr) d'un sujet basée sur des paramètres hémodynamiques

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Publication number
EP2967357A1
EP2967357A1 EP14779148.7A EP14779148A EP2967357A1 EP 2967357 A1 EP2967357 A1 EP 2967357A1 EP 14779148 A EP14779148 A EP 14779148A EP 2967357 A1 EP2967357 A1 EP 2967357A1
Authority
EP
European Patent Office
Prior art keywords
pain
signal
person
light
controller
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP14779148.7A
Other languages
German (de)
English (en)
Other versions
EP2967357A4 (fr
Inventor
Alireza AKHBARDEH
Amir Tehrani
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ropamedics LLC
Original Assignee
Ropamedics LLC
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Filing date
Publication date
Application filed by Ropamedics LLC filed Critical Ropamedics LLC
Publication of EP2967357A1 publication Critical patent/EP2967357A1/fr
Publication of EP2967357A4 publication Critical patent/EP2967357A4/fr
Withdrawn legal-status Critical Current

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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
    • A61B5/01—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
    • A61B5/02028—Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
    • 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
    • A61B5/1455—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 using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—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 using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14553—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 using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases specially adapted for cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/369—Electroencephalography [EEG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/40—Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4058—Detecting, measuring or recording for evaluating the nervous system for evaluating the central nervous system
    • A61B5/4064—Evaluating the brain
    • 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
    • A61B5/4824—Touch or pain perception evaluation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7278—Artificial waveform generation or derivation, e.g. synthesising signals from measured signals
    • 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
    • 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
    • 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

Definitions

  • the present invention is in the medical field of blood flow and brain activity monitoring including hemodynamic measurement. More specifically, the present invention is in the medical, person management, animals and pets management, and pharmaceutical management fields of measuring blood flow and cerebral hemodynamic changes and impacts associated with several sensory stimuli including pain, brain injury, other neurological disorders, and anesthesia as well as others.
  • Measurement of pain can include a subjective component when a person's mood, culture, and other sociological, psychological, and other factors contribute to sensation and reporting of pain. Some persons like neonates, infants, children, Alzheimer persons, and/or persons under anesthesia, or in an ICU, have no mechanism of self-reporting. Also, if pain progression could be measured and a threshold set, early intervention could minimize pain progression. This is also true for persons with migraine or cluster headaches and other pains.
  • Pain management and treatment solutions rely on subjective data. As a result, persons are either over-medicated or under treated. Stimulation devices for treatment of pain could deliver more appropriate therapy if the stimulation level was correlated to objective, independent, reliable, and repeatable pain measurement. The evaluation and treatment of persons occurs because many may not be able to self-report their health condition, and the typical behavioral signs may be subtle or absent.
  • a system indicates pain or a surrogate of pain symptoms of a person and is for use with the tissue of the person.
  • a light source is adapted for illuminating the tissue of the person.
  • An optical sensor is adapted for sensing light emitted or reflected by the tissue of the person. The optical sensor generates a light signal indicative of a light parameter of the sensed light.
  • a surface electrode is adapted for sensing an electrical parameter of the tissue of the person. The surface electrode generates an electrode signal indicative of an electrical parameter of the sensed electrical parameter.
  • a temperature sensor is adapted for sensing a temperature of the tissue of the person. The temperature sensor generates a temperature signal indicative of the sensed temperature.
  • One or more circuits is adapted for receiving the light signal, the electrode signal, and the temperature signal and provides corresponding signals.
  • a controller is adapted for receiving and processing the corresponding signals and is adapted for providing a pain indication signal which is a function of the corresponding signals.
  • An indicator is adapted to be responsive to the controller for providing an indication which is indicative of the pain indication signal.
  • a power supply supplies power to the system.
  • a system for cerebral monitoring of a person and a method for providing an indication of pain of a person such as measuring pain or a surrogate of pain symptoms of a person are also presented.
  • Fig. 1 illustrates a sensor system according to the system and method and a plurality of exemplary locations for the placement of the sensor system on a person's forehead.
  • FIG. 1A is block diagram illustrating a system and method.
  • Fig. 2 illustrates a block diagram of the device for the real-time tracking of the cerebral hemodynamic changes on ambulatory subjects using the Real-time Tracking of Cerebral Hemodynamic Response (RTCHR) system.
  • RTCHR Cerebral Hemodynamic Response
  • Figs. 3A and 3B illustrate the physics of chirp optical modulation to track hemodynamic response changes.
  • Fig. 4 illustrates the period of time during which the assessments of Figs. 5-8 were taken.
  • FIG. 5 illustrates graphs of Objective Pain Level Assessment: hemodynamic changes in response to external severe cold pain stimuli.
  • FIG. 6 illustrates graphs of Objective Pain Level Assessment: hemodynamic changes in response to external severe heat pain stimuli. Hemodynamic response did not return to baseline due to continued burning sensation.
  • FIG. 7 illustrates graphs of Objective Pain Level Assessment: hemodynamic changes in response to external severe sharp pain stimuli.
  • FIG. 8 illustrates graphs of Objective Pain Level Assessment: hemodynamic changes in response to internal severe back pain stimuli. Subject with back pain was asked to twist his back to temporarily increase pain level.
  • FIG. 9 illustrates graphs of heart and respiration rate Estimation: The derivative of forehead pulse can be used to estimate Heart and respiration rates.
  • Vital signs should not be used as primary indicators of person health condition, but rather vital signs should be considered as a cue to begin further assessment.
  • human brain reactivity to external/internal stimuli such as pain and anesthesia has been extensively studied with the use mainly of magnetic resonance imaging and positron- emission tomography.
  • magnetic resonance imaging and positron- emission tomography has been extensively studied with the use mainly of magnetic resonance imaging and positron- emission tomography.
  • the use of these sophisticated methods may be unrealistic as an affordable and ambulatory product for everyday use.
  • Of interest to assessing these persons in a clinical and non-clinical setting is the noninvasive measurement of regional cerebral tissue oxygenation with the pulse oximetry, EEG, and near-infrared spectroscopy (MRS) techniques.
  • An objective of this invention is to develop cheaper techniques of detecting the cerebral hemodynamic characteristics and changes associated with sensory stimuli, including pain and anesthesia, among others.
  • An objective of this invention is to develop a device for real-time profiling and detection of the cerebral hemodynamic patterns and changes on an ambulatory and non-ambulatory subjects using fully automatic and advanced machine learning techniques. Also provided is a system that can communicate and provide person feedback with healthcare professionals or persons to adjust the therapy or adjust other interventions.
  • the present invention includes a device and method for a real-time profiling, pattern recognition, and tracking of the cerebral hemodynamic changes of persons (ambulatory and/or non-ambulatory) using automatic and advanced machine learning techniques to process biological data collected using a sensor patch or a series of sensors (e.g., red and infrared lights transmitters, and/or electroencephalography— EEG, and not limited to other sensors such as accelerometers, position sensor, impedance sensor, and the like).
  • sensors e.g., red and infrared lights transmitters, and/or electroencephalography— EEG, and not limited to other sensors such as accelerometers, position sensor, impedance sensor, and the like.
  • a device could be designed and used for neonatal persons where a baseline is created and deviation from brain hemodynamics and/or other sensor parameters could alarm the nurse of infants' discomfort which could lead to pain progression or distress.
  • the device could be a patch with wireless data communication capability.
  • the device could transmit and receive data from the hospital monitor.
  • the device could also include visual, audio, or electronic feedback such as colored LEDs, alarm, or data transmission to inform the hospital staff or parents of the pain or stress status of the person.
  • the device could include an optional microphone (122; see Fig. 1A) to record neonates crying and distress levels.
  • the device could also simultaneously detect and measure the hemodynamic or other sensors levels to define a pain or cry threshold.
  • Such a device could be programmed to alarm the hospital staff and parents that the neonate is progressing toward higher levels of pain and distress. Therefore, an intervention could be applied before the neonate reached a maximal pain or distress level.
  • a device could be designed and developed for persons under anesthesia undergoing surgery. These persons have no capability to report pain. Similar to the previously described device, a profile and threshold of the hemodynamic and other sensors could be established even prior to surgery when the person is awake and continue to record sensor measurements during surgery. If a device detects deviation from the anesthesia baseline that indicates pain or consciousness, the anesthesiologist could adjust the drug levels to comply with device trending and recommendation. This device could be a patch that also includes communications and person feedback, which can also be integrated with hospital monitoring systems. In yet another embodiment, a device could command the anesthesiologist or the anesthesia machine to deliver additional drugs to minimize pain or sensors information deviation measured by the device. In an embodiment, all devices could be disposable or reusable.
  • a device could be worn by an ambulatory, nonambulatory, or mobile person where the pain management device directly communicates with a control device.
  • the control device could be a pager, a mobile phone with an app, or other variation.
  • the control device could be programmed to request a measurement from the hemodynamic measurement device. This measurement could be programmed on hourly, daily, or other intervals.
  • the person himself could request for an objective pain measurement through use of the mobile device. If the patch senses deviation from a baseline or emergence of pain is imminent, while it takes the objective measurements, it could send a signal to the mobile device and request the person to include his subjective level of pain. Such simultaneous objective and subjective pain measurement data could be matched and used for better treatment of the person.
  • Such a device could be a non-invasive patch or an implantable device placed under the hair, in forehead, or another part of the head and neck. This device could be a very thin and invisible device. Such a device is capable of measurements on-demand, objective, and subjective pain, and other sensor data.
  • the device includes a position sensor.
  • the device could also include a GPS sensor as certain environments and/or movements could lead to higher level pain inducement or sensation.
  • Such a device could also be used to measure a person's compliance with medications of other therapies.
  • the mobile device could remind the person of taking medications on time and, within a given interval of time, measure changes in objective pain measurements to learn if the medication was effective.
  • Physicians can also program and/or receive information about person objective, or subjective pain levels and medication of other therapy compliance. Physicians could also command pain level measurements both objective from the patch and subjective from the mobile device app and the person. The received information could be used for treatment titration and compliance improvement.
  • the device and method could also include communications in the form of a Q&A with the person to better categorize pain, mood, stress, emotional, and behavioral variations in sensor measurements level.
  • the sensors results could be matched with a person's conditions and/or environments to therefore provide improved person pain management.
  • the objective sensor measurement may be combined, synchronized, and/or aligned with a person's subjective input in a variety of environments.
  • the devices or methods of the invention could be implemented to aid in reducing addictions to opiates medication, i.e., narcotics and pain killers such as OxycontinTM (onycodone HCl).
  • Addiction to opiate drugs are increasing at alarming rates and causing significant issues to the healthcare system including rising costs, suicides, and dependencies. However, if these drugs are administered when the patient really needs it rather than at a prescribed rate, there is a possibility to reduce dependencies.
  • the devices or methods of the invention could also help to self-discipline or discipline patients to administer/consume the medications when there is significant pain on the horizon.
  • the predictability of rising pain levels based on history of a patient could help with minimizing the required medication to treat the pain at an early onset. Therefore, at least some embodiments of the devices or methods of the invention could minimize required medications for the treatment of pain.
  • the real-time tracking of cerebral hemodynamic response (RTCHR) optical technology systems unlike pulse oximetry, uses chirp modulation in the hardware to measure the level of hemogolobin oxygenation ("oxy Hb").
  • the RTCHR technology is also different than spectroscopy because spectroscopy requires several wavelengths of light.
  • the pulse oximeter uses the property that oxyhemoglobin and deoxyhemoglobin absorb light of different wavelengths in a specific way.
  • a light source is provided to sequentially pass light of different wavelengths through a sample of oxy Hb.
  • a detector determines the amount of light, at each wavelength, has been absorbed.
  • Pulse oximetry uses two wavelengths (i.e., 650 and 950 nm).
  • the pulse oximeter determines the oxygen saturation by comparing the amount of red light and infra-red light are absorbed by the blood. Depending on the amounts of oxy Hb and deoxy Hb present, the ratio of the amount of red light absorbed compared to the amount of infrared light absorbed changes.
  • fNIRS Near-Infra-Red Spectroscopy
  • Typical applications include pharmaceutical, medical diagnostics (including blood sugar and blood oxygenation), food and agrochemical quality control, and combustion research, as well as research in functional neuroimaging, sports medicine & science, elite sports training, ergonomics, rehabilitation, neonatal research, brain computer interface, urology (bladder contraction), and neurology (neurovascular coupling).
  • NIRS In NIRS, multiple LED senders and receivers with different wavelength/light settings are used to get light reflection at different wavelengths. To get more spectrum data at more wavelengths, more LED sensors and receivers are needed. This dramatically increases the price of the NIRS, and it increases complexity of hardware and software.
  • the device includes the correlation of presence and level of pain with heart rate, temperature, brain activity, blood pressure, or vice versa.
  • the system measures all these parameters simultaneously and can analyze the data to identify patterns and intelligence.
  • the system could also correlate pain level to certain positions, activity levels, and/or locations/environments.
  • the system could be used for human and animal subjects as well. Pet owners have significant interests to know if their pets are experiencing pain, and if the pain management and treatment is effective. Therefore, another variation of this device could be designed and developed to fit certain pet specifies. The system could be used for drug/pharmaceutical development purposes as well.
  • FIG. 1 shows a lateral view of the face and location of a real-time tracking of cerebral hemodynamic response (RTCHR) patch system 100 for real-time tracking of cerebral hemodynamic response changes on an ambulatory subject. It records hemodynamic response changes, heart rate, respiration, and Electroencephalogram (EEG). To localize hemodynamic response and estimate stimulus type, one or more additional patch systems 100 positioned on the forehead, on the skull or other part of body can be used.
  • RTCHR cerebral hemodynamic response
  • EEG Electroencephalogram
  • Data acquisition unit 5 to fetch data from sensors, apply any necessary filtering, convert the sensor data in a form for transmission to a control 7, and transmit recorded sensor data via wired or wireless transmission to the control 7.
  • Display 6 such as LCD/LEDs on the patch system 100 to display pain level and heart/respiration rates.
  • Control 7 fetches sensor data via wired or wireless transmission line and applies necessary signal processing and machine learning techniques to estimate hemodynamic parameters in real-time while subject can do his/her normal daily activities. It then displays the hemodynamic parameters and stores raw and estimated results in a dedicated server.
  • the control box could be stand-alone or integrated with patch.
  • Fig. 1A is block diagram illustrating a RTCHR system 100 and method.
  • the system 100 measures pain of a person and is for use with the tissue (e.g., skin) of the person.
  • a light source 102 is adapted for illuminating the tissue of the person.
  • An optical sensor 104 is adapted for sensing light emitted or reflected by the tissue of the person.
  • the optical sensor 104 generates a light signal indicative of a light parameter of the sensed light.
  • the light signal is indicative of pulse oxygen levels, respirations and heart rate.
  • a surface electrode 106 is adapted for sensing an electrical parameter of the tissue of the person.
  • the surface electrode 106 generates an electrode signal indicative of an electrical parameter of the sensed electrical parameter.
  • the electrode signal is indicative of heart rate, sweat and respirations.
  • a temperature sensor 108 is adapted for sensing a temperature of the tissue of the person.
  • the temperature sensor 108 generates a temperature signal indicative of the sensed temperature.
  • the temperature signal is indicative of body temperature.
  • One or more circuits 110 are adapted for receiving the light signal, the electrode signal, and the temperature signal and providing corresponding signals 112.
  • the circuits 110 apply any necessary filtering, convert the sensor data in a form for transmission to a controller 1 14, and transmit recorded sensor data via wired or wireless transmission to the controll 14.
  • the controller 114 includes optional telemetry circuitry to communicate with other devices.
  • the controller 114 may communicate with a mobile device such as a cell phone or hospital monitor and provide information indicative of the signals to the mobile device.
  • the controller 114 is adapted for receiving and processing the corresponding signals and is adapted for providing a pain indication signal which is a function of the corresponding signals.
  • An indicator 116 is adapted to be responsive to the controller 1 14 for providing an indication which is indicative of the pain indication signal pain signal such as a signal indicative of measured pain or indicative of a surrogate of pain symptoms.
  • the pain indication signal is also referred to as a pain signal
  • a power supply 118 supplies power to the system.
  • a motion sensor 120 is adapted for sensing a motion of the person.
  • the motion sensor 120 generates a motion signal indicative of the sensed motion.
  • the controller 114 is adapted for receiving and processing the motion signal and is adapted providing the pain signal as a function of the motion signal and as a function of the corresponding signals.
  • the indicator 116 may be driven by the circuit(s) 110 and/or by the controller 114.
  • the controller is a processor having a memory device 122 storing computer executable instructions for calculating the pain signal and wherein the processor is adapted to execute the instructions.
  • a method for measuring pain of a person is described.
  • the method is for use with the tissue of the person, and comprises:
  • the phrase measuring pain as used in this document is in reference to measuring one or more parameters that are reflective of pain. As doctors will understand, the device does not measure pain per se but measures one or more parameters that are reflective of pain and directly related to a level of pain.
  • the motion sensor comprises at least one of an accelerometer; a GPS sensor; and a gyroscope.
  • the light source comprises at least one of: a light source emitting light having a frequency in the range of near infrared wavelengths (e.g., about 1014 Hz; about lOOOnm in wavelength); an LED (light emitting diode); an LED emitting visible light; and an LED emitting light having a frequency in the range of infrared wavelengths (e.g., between 101 1 to 1015 Hz; between lOOOnm to 1 cm in wavelength).
  • a light source emitting light having a frequency in the range of near infrared wavelengths e.g., about 1014 Hz; about lOOOnm in wavelength
  • an LED light emitting diode
  • an LED emitting visible light e.g., between 101 1 to 1015 Hz; between lOOOnm to 1 cm in wavelength
  • the optical sensor comprises at least one of: a photodetector; and a light sensitive element and the light parameters comprise at least one of: light intensity; light frequency; light wavelength; and a light emitting pattern (chirp pattern).
  • the surface electrode comprises at least one of: an electrode (e.g., a wet electrode, an AG/AGCL Electrode (Lead), or a dry electrode such as metal probes adapted to contact the tissue); and conductive elements adapted to contact the tissue.
  • an electrode e.g., a wet electrode, an AG/AGCL Electrode (Lead), or a dry electrode such as metal probes adapted to contact the tissue
  • conductive elements adapted to contact the tissue.
  • the electrical parameters comprise at least one of: voltage; current; resistance; capacitance; inductance; impedance; and charge.
  • the temperature sensor comprises at least one of: a resistive temperature sensitive element; a bi-metallic element; and a MEMS temperature sensor.
  • the one or more circuits comprise: an analog to digital circuit; a signal conditioning circuit; a filtering circuit; and hardware and drivers for optical transceivers in both normal and chirp modulation modes.
  • the light source, the optical sensor, the surface electrode, the temperature sensor and the one or more circuits comprise one unitary, integrated component and the controller is a separate, unitary, integrated component and further comprising a wireless link between the controller and the one or more circuits.
  • the light source, the optical sensor, the surface electrode, the temperature sensor, the one or more circuits, the power supply and the controller comprise one unitary, integrated component.
  • the indicator comprises at least one of: one or more LEDs; an LCD device; a screen; and a set of LEDs operating in visible wavelength as indicators of hemodynamic change rate and/or pain level.
  • the controller comprises a processor having a memory device storing computer executable instructions which estimate hemodynamic parameters and wherein the processor is adapted to execute the instructions.
  • the hemodynamic parameters comprise at least one of the following: hemoglobin oxygenation; hemoglobin deoxygenation; heart rate; respiration rate; forehead and/or body temperature; and forehead and/or body impedance.
  • the controller comprises a processor having a memory device storing computer executable instructions wherein the processor processes the received, corresponding signals according to at least one of the following: instructions for an algorithm to compute the pain signal based on hemodynamic parameters and hemodynamic response to external and/or internal stimulus in real-time or near real-time; instructions for comparing the signals to a reference (history of hemodynamic parameters and hemodynamic response; and instructions for scaling the hemodynamic response to the range of [0, 10].
  • the instructions for the algorithm executed by the processor comprises instructions for fusing over a preset time interval a plurality of samples of a magnitude of the light signal LS, the electrode signal ES, and the temperature signal TS, adjusted by preset weights a, b, and c, to compute a pain indicative signal PS corresponding to a fused signal according to the following:
  • Fused Signal ⁇ (a*LS + b*ES + c*TS).
  • the instructions for the algorithm executed by the processor comprises instructions for using over a preset time interval a plurality of samples of a magnitude of a light pain signal LPS indicative of a pain level, an electrode pain signal EPS indicative of a pain level, and a temperature pain signal TPS indicative of a pain level, adjusted by preset weights a, b, and c, to compute an estimated pain indicative signal PS corresponding to a fused signal according to the following:
  • Fused Signal ⁇ (a*LPS + b*EPS + c*TPS).
  • the instructions for the algorithm executed by the processor comprises instructions for summing over a preset time interval of a plurality of samples of a magnitude of the light signal LS, the electrode signal ES and the temperature signal TS, wherein each sample is compared to preset ranges and the magnitude of the signals is adjusted according to a relationship between each signal and the preset ranges.
  • the instructions comprise instructions for inputting personal input into the controller by an input device such as a keypad or keyboard, the personal input including conditions and/or environments of the person and wherein the pain signal is coordinated with the personal input whereby improved person pain management is provided.
  • the personal input includes a level of consciousness indicator, such as:
  • the controller processes at least one of the corresponding signals according to chirp based optical modulation.
  • the optical sensor comprises a blood oxygenation sensor for sensing a blood oxygenation of the person and wherein the chirp based optical modulation by the processor comprises measuring the light signal in different wavelengths as indicative of blood oxygenation.
  • the chirp based optical modulation comprises varying a carrier frequency in optical modulation over time to mimic hemodynamic response in different wavelengths over time to detect hemodynamic response recursively over time in a serial (recursive) approach.
  • the controller calculates respirations and heart rate by evaluating different frequency components in raw sensor data from the optical sensor.
  • a respiratory signal has a frequency component of the raw data [2-5Hz] which can be extracted using a band pass frequency with cut off [2-5Hz], and wherein the processor evaluates frequency components of 5-100Hz to obtain heart rate.
  • the controller comprises a processor having a memory device storing computer executable instructions comprising machine learning techniques and wherein the processor is adapted to execute the instructions, wherein the machine learning techniques include at least one of: adaptive and non-adaptive noise cancelation of noise in the signals; signal Envelope Detection; low pass, band-pass, band-stop and high pass digital filters to extract different hemodynamic parameters from sensor data spectrum; and supervised or unsupervised clustering including at least one of k-means, fuzzy c-means artificial neural networks, support vector machine, fuzzy systems to characterize hemodynamic response across different persons (persons) and across days (inter and intra subject variability characterization).
  • the machine learning techniques include at least one of: adaptive and non-adaptive noise cancelation of noise in the signals; signal Envelope Detection; low pass, band-pass, band-stop and high pass digital filters to extract different hemodynamic parameters from sensor data spectrum; and supervised or unsupervised clustering including at least one of k-means, fuzzy c-means artificial neural networks, support vector machine, fuzzy systems
  • the controller calibrates the system using a baseline wander correction algorithm based on at least one of adaptive or non-adaptive filtering.
  • data is provided to the controller indicative of feedback from a person to train the controller or set a range.
  • the data comprises subjective pain measurements from the person synchronized with pain indicator measurements by the system, wherein the subjective pain measurement comprise:
  • the controller synchronizes objective hemodynamic parameters of the sensor signals with subjective measurements provided by the person so that the sensor and person or a physician establishes communication and coordination between the sensors and the person or physician.
  • the controller generates commands to which the person responds to at a particular point to define a baseline.
  • the device will continuously or at programmed intervals ask the person to respond to the device by defining his subjective pain level through a mobile phone or other communication interface.
  • the device/system is capable of calibrating/coordinating its objective measurements with the person's subjective measurements. This process will also help with baseline creation so that the objective and subjective pain levels correlate at the moment in time.
  • the controller is responsive to a person or physician to trigger the hemodynamic monitor to make measurements and define a baseline.
  • a person indicates his/her pain status among environmental parameters to train the device for threshold definition.
  • the device communicates with the persons regarding its pain status in order to define a baseline and threshold for device training and personalization.
  • the system is configured to be implantable within a person.
  • One device variation could be a single patch placed on the person forehead, head, or neck.
  • Another optional variation could be multiple sensors being placed on the forehead or circumference of the head similar to a bandana.
  • Yet another optional variation of the device and method could be an implantable device with sensors and battery and wireless operation that can be continuous or activated by mobile phone or any other activator to activate the sensor for a programmed period of time and transmit information to the receiver outside or inside the body.
  • the implantable device could be rechargeable over the scalp. This implantable device could be implanted underneath hair in or underneath the scalp via a simple insertion like a hairpin or incision. The implantable device will be removable as well.
  • Implantable device could have flat or other geometrical form factors to fit the person's head/scalp/skull.
  • the receiver device could be a mobile phone, a hat, headband, or other similar form factors.
  • the implantable device could be powered using an external power source such as an RF generator or coil-to-coil power generation where a capacitor in the device stores enough energy to perform a required measurement and transmission of the information.
  • the Real-Time Tracking of Cerebral Hemodynamic Response (RTCHR) system 100 includes three stages.
  • a first stage 202 employs a sensor unit for recording data.
  • the sensor unit includes, for example, a surface electrode and optical sender/receiver LEDs, an accelerometer, a GPS, and temperature sensors.
  • the sensor data are processed and properly conditioned in the next stage 204 and then, with a wired or wireless transmission unit, the sensor data are transferred at a third state 206 to a control for further processing (e.g., advance real-time signal processing and machine learning) to estimate hemodynamic response changes due to external/internal stimulus (anesthesia, pain, and the like), heart rate, respiration and other parameters.
  • further processing e.g., advance real-time signal processing and machine learning
  • the advance real-time signal processing stage includes real-time denoising, baseline wander removal, extraction of different band of sensor data related to heart pulse, respiration and/or cerebral hemodynamic response trace based on frequency domain filtering envelop detection and real-time source separations.
  • To estimate hemodynamic response change over time some statistical and morphological features such as norm, root-mean-square, skewness, kurtosis, entropy, and the like are extracted and input to a real-time machine learning stage to compare blood oxygen consumption pattern between present and past.
  • machine learning based predictive models can be used to predict onset of pain in the close future in pain management applications.
  • FIG. 3 A illustrates on the left a graph of the absorption of spectra of oxy-Hb and deoxy-Hb in the near infrared range (the three graphical lines illustrate Hb0 2 , Hb, and water, from left to right).
  • FIG. 3A on the right illustrates the path of light on a human head from emitter to detector.
  • a chirp signal such as illustrated in FIG.
  • 3B is used to emit light with different wavelengths in red and near infra-red ranges.
  • chirp modulation according to the invention, tracking of hemodynamic response changes will be maximized and RTCHR provides a new class of optical sensing compared to oximetry and spectroscopy.
  • Chirp based optical modulation measures blood oxygenation in different wavelengths.
  • chirp modulation a carrier frequency in optical modulation varies over time to mimic hemodynamic response in different wavelengths over time.
  • oximetry only two wavelengths are used and in NIR spectroscopy a set of optical senders and receivers are used to get hemodynamic responses over different wavelengths in parallel.
  • Chirp based optical modulation according to one aspect of the invention detects hemodynamic response recursively over time. Since hemodynamic response is slow, the system detects hemodynamic responses over different wavelengths in a serial (recursive) approach.
  • Modulation pattern and number and range of frequency (wavelength) modulation can be controlled by a person at software level, but hardware for chirp modulation may also be used to implement control. For instance, a person could take two wavelengths readings, one in red field and another in near-infra red. On this case, the device acts as a pulse oximeter. In other words, the system with its novel recursive modulation ability can induce any pattern including two wavelength readings (oximeter mode) or chirp mode (multiple wavelengths reading). [ 0079 ] It is noteworthy that the single forehead patch could include several of the hemodynamic and other sensors for multiple measurements across different locations on the forehead or the brain.
  • a typical application for RTCHR system 100 and method according to the invention provide objective pain level assessment.
  • the system 100 and its method are capable of estimating pain level by tracking hemodynamic baselines and/or changes in response to internal/external pain stimulus. For example, in one embodiment, previous sensor readings from few minutes and/or hours ago are used as baseline hemodynamic response and the current sensor reading is compared with the history of data to determine level of deviation.
  • a baseline could be arbitrary.
  • a nurse, doctor, or the person starts baseline recording at a certain point in time or under certain conditions, this also could be considered baseline.
  • the device/system will allow a person (e.g., person, doctor, technician) to choose and set up a certain condition as "baseline”. Yet, when an infant cries or is in stress due to pain, the higher level or threshold could be considered baseline, too, not necessarily the lowest measurement.
  • a baseline is a reference, either arbitrary or defined.
  • a baseline is a reference point.
  • a baseline may be established in several ways. 1) When the subject is in a normal state or in pain. In a normal state, any increase in pain is tracked; in a pain state, increases or decrease in pain due to therapy are tracked. 2) In a situation where there is previous data from a person, the data may be used to establish a baseline, such as body temperature or blood pressure. For example, one day data could be used to establish a normal range of body temperature.
  • FIG. 5-8 illustrate the recorded data, showing the hemodynamic changes in response to external and internal pain stimulus.
  • the Y- axis is an estimated pain level (1st norm scaled to 0-10) per second for first and second subplots and per 10 second for the third subplot.
  • Fig. 4 illustrates the period of time during which the assessments of Figs. 5-8 were taken.
  • FIG. 5 illustrates graphs of Objective Pain Level Assessment: hemodynamic changes in response to external severe cold pain stimuli. Levels 1-10 during the first 20 seconds illustrate the baseline. Levels 11-20 during the next 20 seconds illustrate the response during pain stimulus. Levels 21-30 during the last 20 seconds illustrate the response during recovery after pain stimulus has ended.
  • FIG. 6 illustrates graphs of Objective Pain Level Assessment: hemodynamic changes in response to external severe heat pain stimuli. Hemodynamic response did not return to baseline due to continued burning sensation. Levels 1-10 during the first 20 seconds illustrate the baseline. Levels 1 1-20 during the next 20 seconds illustrate the response during pain stimulus. Levels 21-30 during the last 20 seconds illustrate the response during recovery after pain stimulus has ended.
  • FIG. 7 illustrates graphs of Objective Pain Level Assessment: hemodynamic changes in response to external severe sharp pain stimuli. Levels 1-10 during the first 20 seconds illustrate the baseline. Levels 1 1-20 during the next 20 seconds illustrate the response during pain stimulus. Levels 21-30 during the last 20 seconds illustrate the response during recovery after pain stimulus has ended.
  • FIG. 8 illustrates graphs of Objective Pain Level Assessment: hemodynamic changes in response to internal severe back pain stimuli. Subject with back pain was asked to twist his back to temporarily increase pain level. Levels 1-10 during the first 20 seconds illustrate the baseline. Levels 11-20 during the next 20 seconds illustrate the response during pain stimulus. Levels 21-30 during the last 20 seconds illustrate the response during recovery after pain stimulus has ended.
  • FIG. 9 illustrates graphs of heart and respiration rate Estimation:
  • the derivative of forehead pulse can be used to estimate Heart and respiration rates.
  • Figure 9 shows a typical forehead pulse and estimated heart and respiration rates.
  • the processor evaluates different frequency components in raw sensor data from the optical sensor.
  • a respiratory signal is a frequency component of the raw data [2-5Hz] which can be extracted using a band pass frequency with cut off [2-5Hz].
  • the processor evaluates frequency components of 5-100Hz.
  • Heart rate and/or respiration rate can be measured or calculated manually or automatically.
  • respiration rate and heart rate signals can be extracted from a light signal and/or surface electrode signal and for analysis according to at least some embodiments of the systems and methods of the invention.
  • RTCHR Another application for RTCHR is in the area of sensation as associated with brain activity. Images in movies and photos can generate empathic pain. Subjects shown a series of images or movies with injuries or other pain related events have reported definite pain to at least one image of movie. It has been determined that subjects who report pain in response to such images activate pain matrix regions in the brain, which are responsible for generating pain. Therefore, observing painful images modulates motor responses, which suggest sensorimotor involvement. For example, a person reported feeling physical pain when observing his wife experience superficial pain.
  • somatic pain e.g., tingling, aching, sharp, shooting, throbbing, sickening, splitting, heavy, stabbing, and tender types of pain have been described
  • visceral pain e.g., somatic pain (e.g., tingling, aching, sharp, shooting, throbbing, sickening, splitting, heavy, stabbing, and tender types of pain have been described) and visceral pain.
  • rCBF response to heighted unpleasantness has been recorded. Pain activates a large amount of neural tissue.
  • Imaging studies have illustrated that chronic pain is associated with functional, structural and chemical changes in the brain; however, it is not known how neural activity is translated into a feeling. Areas of the brain that are usually active provide for pain inhibition, and a lack of pain inhibition causes chronic pain.
  • pain is reported by asking subjective questions of persons and not by imaging anatomic information and determining the activation of brain distress centers.
  • RTCHR may be used to better evaluate
  • fMRI Magnetic Resonance Imaging
  • the fJVIRI records the variable magnetic property of tissue.
  • fMRI scanning has been utilized during the presentation of real noxious heat stimuli, as well as during the suggestion of a real noxious heat stimuli to a set of eight subjects. All the subjects reported a sensation of at least heat during the suggestion and five reported pain.
  • fMRI can determine the Blood Oxygen Level Dependent (BOLD) signal, which measures an "effect parameter".
  • BOLD Blood Oxygen Level Dependent
  • RTCHR may be used to better evaluate and understand these aspects.
  • fMRI has been used to study empathetic pain. For instance, ten pain responders and ten non-responders acting as controls were give a set of pain images and a set of emotional images. Using fMRI the anterior midcingulate cortex ("aMCC") was monitored. The responders consistently activated aMCC, anterior insula, prefrontal cortex and primary (S I) and secondary (S2) somatosensory cortex for all pain images and emotional images. In contrast, the non-responders consistently activated aMCC and prefrontal cortex but failed to activate insula, SI or S2. Therefore, regional activation is specifically and actively involved in the generation of pain, and empathetic pain appears to involve the same mechanism.
  • aMCC anterior midcingulate cortex
  • RTCHR may be used to better evaluate and understand these aspects.
  • RTCHR provides objective measurements hemodynamic response, heart and respiration rates, to determine and predict the onset of pain.
  • Offset analgesia is the perception of profound analgesia during a slight incremental decrease of a noxious heat stimulus that is more pronounced than would be predicted by the rate of the temperature decrease. Offset analgesia is an active process probably involving descending inhibitory mechanisms to modulate pain.
  • a device of the invention it is possible to utilize a device of the invention to measure issues with brain development in neonates. Some neonates have problems with normal development of the brain and the device is helpful to detect and report such issues despite whether the neonate feels pain or not. For example, a "normal" level of sensor measurement expected in a larger group of neonates (expected baseline data) can be used as a baseline to compare to other neonates who have severe deviation from the baseline.
  • the device may be used for cerebral monitoring such as a particular brain function monitoring instead of the pain application.
  • the device in at least certain persons may indicate or detect early onset of epilepsy or another brain related issues (e.g., Alzheimer, Parkinson's, brain tumors).
  • the device may be used to capture early onset of epilepsy or another brain related issues in an inexpensive and ambulatory way by use of a single patch on a forehead or a person or at other locations on the body.
  • the pain signal comprises a cerebral monitoring signal.
  • the device may be used by athletes for performance enhancement as it relates to cerebral flow and pain perception.
  • feedback from the person may be used to train the system 100 or set a range.
  • a person may choose which days/time should be compared with current time [reference point and baseline setting].
  • a person's subjective pain level can be compared with objective (automated) pain assessment. This is called interactive pain. Enabled with artificial intelligence and real-time learning mode, this applies self-tuning, particularly when there is a large difference between objective and subject pain levels.
  • a pulse oximeter can be modified to also provide a cerebral hemodynamic tracking system according to the invention to measure pain, trauma, epilepsy, level of consciousness, attention monitoring and other brain related applications.
  • the pulse oximeter is modified to detect a light signal, an electrical parameter electrode signal and a temperature signal.
  • the firmware of pulse oximeter is updated to have access to raw data from LEDs and apply an algorithm for generating a pain signal which is a function of the corresponding signals and for providing an indicator indicative of the pain signal.
  • baseline wander correction algorithms may be used to perform self-calibration and to account for sensor data drift coming from hardware and/or human condition changes such as sweating or motion.
  • Another application of at least some embodiments of the device or method of the invention is in various product configurations for the OBGYN applications.
  • a consumer patch and a smart phone app could be used to track uterus contractions prior to childbirth.
  • expectant mothers have to record the frequency of the uterus contractions and keep a record with a timer in hand. Once contractions happen too closely, it will be time to attend a clinic or hospital for child delivery. So often expectant mothers miss the true contraction frequency and associated pain level. Uterus contractions cause proportional pain.
  • At least some embodiments of the device or method of the invention attached to the forehead could keep track of the pain associated with the uterus contractions and maintain a concise time and pain amplitude profile without a subject's intervention. As a result, at least some embodiments of the device or method of the invention could advise the subject when to attend to the clinic while simultaneously transmitting the complete contraction profile to the clinic or the attending doctors prior to arrival.
  • At least some embodiments of the device or method of the invention could be used for epidural pain management to measure pain and automatically administer pain medication.
  • At least some embodiments of the device or method of the invention could be used for post childbirth pain management in natural or C-section type childbirth where pain management is a major issue. All data collected can be integrated into a patient profile at the hospital EMR.
  • Yet another application could be a handheld device for tracking children pain due to teething or other painful situations to assist parents in managing children or infant pain.
  • At least some embodiments of the device or method of the invention could be similar to a handheld thermometer with memory. Routine baseline measurements can be recorded. Once the infant is in a stressful situation and crying for no apparent reason, parents can place the device on the forehead for a period of time to measure if pain is present.
  • At least some embodiments of the device or method of the invention could be be used on neonates at the hospitals or non- responders in ICU and nursing homes.
  • At least some embodiments of the device or method of the invention could be programmed to either administer a drug by instructing the infusion to deliver more medication, wake the patient up by sound or other stimulus, or send a notification to the nursing station. Therefore, pain is managed continuously even when patients are sleep. All data from the device will be integrated into the hospital EMR.
  • Pain medication drug discovery today is a cumbersome process. During clinical trials, a patient is asked for a subjective pain level in order to learn if the drug is effective. So often this type of drug discovery leads to failure due to a placebo effect or improper subjective pain level reporting. Utilizing at least some embodiments of the device or method of the invention, a majority of the ambiguity in pain drug discoveries could be resolved. Companies also can receive real-time effect of their newly developed pain medications from subjects and patients enrolled in clinical trials in realtime.
  • Yet another variation of At least some embodiments of the device or method of the invention could be to identify and diagnose other neurological disorders such as onset or prediction of bipolar disorder, mood change, schizophrenia, and/or depressions.
  • Examples of well known computing systems, environments, and/or configurations that may be suitable for use with aspects of the invention include, but are not limited to, personal computers, server computers, hand-held or laptop devices, multiprocessor systems, microprocessor-based systems, set top boxes, programmable consumer electronics, mobile telephones, network PCs, minicomputers, mainframe computers, distributed computing environments that include any of the above systems or devices, and the like.
  • Embodiments of the aspects of the invention may be described in the general context of data and/or processor-executable instructions, such as program modules, stored one or more tangible, non-transitory storage media and executed by one or more processors or other devices.
  • program modules include, but are not limited to, routines, programs, objects, components, and data structures that perform particular tasks or implement particular abstract data types.
  • aspects of the invention may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network.
  • program modules may be located in both local and remote storage media including memory storage devices.
  • processors, computers and/or servers may execute the processor- executable instructions (e.g., software, firmware, and/or hardware) such as those illustrated herein to implement aspects of the invention.
  • processor- executable instructions e.g., software, firmware, and/or hardware
  • Embodiments of the aspects of the invention may be implemented with processor-executable instructions.
  • the processor-executable instructions may be organized into one or more processor-executable components or modules on a tangible processor readable storage medium.
  • Aspects of the invention may be implemented with any number and organization of such components or modules. For example, aspects of the invention are not limited to the specific processor-executable instructions or the specific components or modules illustrated in the figures and described herein. Other embodiments of the aspects of the invention may include different processor-executable instructions or components having more or less functionality than illustrated and described herein.

Abstract

L'invention concerne un système de mesure de la douleur d'une personne, le système étant destiné à être utilisé en association avec les tissus de la personne. Divers capteurs et détecteurs sur les tissus fournissent des signaux à un dispositif de contrôle pour déterminer et indiquer un niveau de douleur de la personne. Tous les constituants peuvent être intégrés en une unité ou séparés en une unité de détection qui communique sans fil avec une unité de traitement.
EP14779148.7A 2013-03-11 2014-03-11 Surveillance d'une réponse hémodynamique cérébrale en temps réel (srhctr) d'un sujet basée sur des paramètres hémodynamiques Withdrawn EP2967357A4 (fr)

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WO2020031106A2 (fr) * 2018-08-07 2020-02-13 Goldtech Sino Ltd Cartes de santé pour naviguer dans un espace de santé
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US20080091089A1 (en) * 2006-10-12 2008-04-17 Kenneth Shane Guillory Single use, self-contained surface physiological monitor
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US8512240B1 (en) 2007-11-14 2013-08-20 Medasense Biometrics Ltd. System and method for pain monitoring using a multidimensional analysis of physiological signals
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