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WO2019070375A1 - Systèmes et procédés informatiques de surveillance du muscle cardiaque d'un patient à l'aide d'un contrôle contextuel - Google Patents

Systèmes et procédés informatiques de surveillance du muscle cardiaque d'un patient à l'aide d'un contrôle contextuel Download PDF

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Publication number
WO2019070375A1
WO2019070375A1 PCT/US2018/050501 US2018050501W WO2019070375A1 WO 2019070375 A1 WO2019070375 A1 WO 2019070375A1 US 2018050501 W US2018050501 W US 2018050501W WO 2019070375 A1 WO2019070375 A1 WO 2019070375A1
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WO
WIPO (PCT)
Prior art keywords
patient
disease
dna
data
predictors
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.)
Ceased
Application number
PCT/US2018/050501
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English (en)
Inventor
Paul M. Diperna
Jr. Freeman H. Rose
Adam S. Colton
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.)
National Cardiac Inc
Original Assignee
National Cardiac Inc
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.)
Filing date
Publication date
Priority claimed from US15/724,131 external-priority patent/US20190034594A1/en
Application filed by National Cardiac Inc filed Critical National Cardiac Inc
Publication of WO2019070375A1 publication Critical patent/WO2019070375A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

Definitions

  • the present invention pertains to systems and methods for monitoring the heart muscle function of a patient for the purpose of evaluating the health and wellbeing of the patient. More particularly, the present invention pertains to systems and methods that monitor and evaluate physiological and environmental data in light of patient-specific data, to consider the interaction of all pertinent factors that affect the health and wellbeing of the patient. The present invention is particularly, but not exclusively, useful for systems and methods that provide a contextual oversight capability for evaluating a patient's heart muscle function.
  • an electrocardiogram is capable of accurately recording the waveform of a heart muscle function. Furthermore, there are trained clinicians who can interpret the EKG waveform to identify and diagnose many different heart muscle irregularities. Thus, insofar as physiological factors are concerned, an EKG-type sensor can continuously provide valuable physiological data that is pertinent to the heart muscle. Further, valuable physiological factors can be collected by disposable skin patches that harvest DNA and surface analyt.es by contact with the skin of a patient. These patches can then be periodically collected and evaluated. Thus, EKG data may be effectively augmented.
  • EKG i.e. heart muscle waveform parameters
  • environmental factors i.e. external influences
  • temperature, weather conditions, trauma, time of day and situational perceptions are all environmental factors that may necessarily need to be taken into account.
  • environmental factors tend to be episodic and of relatively short duration. Nevertheless, their effect on the heart muscles can have long lasting consequences.
  • sensors, other than an EKG such as accelerometers, thermometers, audiometers and potentiometers, are more appropriate for measuring and detecting the impact of environmental factors.
  • patient data to include medical records, behavioral patterns, care plans, and clinical perceptions, are factors that need to be considered along with physiological and environmental factors. It is also an important consideration that, unlike the physiological and environmental data that can be continuously monitored, the collection of patient data will necessarily require frequent updating.
  • DNA/analyte samples can be obtained from such sources as a patient's skin, nails, hair, saliva, blood, perspiration, mucus, urine, proteins, toxins, markers, fecal matter and other body secretions, included here are analyte samples that can typically be harvested directly from the skin of a patient. Accordingly, for disclosure purposes, physiological data pertinent to a patient's DNA and/or surface analytes will hereinafter be collectively referred to as DNA/analyte samples. Such samples are then appropriately analyzed to provide information regarding a patient's health risk factors, his/her hereditary tendencies, allergies and drug responses. Importantly, they also provide information about the severity of a disease, a time-line for disease progression, and the efficacy of acceptable treatment regimens.
  • the results of a DNA/analyte analysis can be useful for supplementing other data relative to a patient's heart muscle function.
  • all of this information can be formatted as data for input to a computer-based system.
  • an object of the present invention to provide a system and method for monitoring the heart muscle function of a patient with contextual oversight that interactively considers the effect that physiological, environmental, and patient-specific factors will collectively have on the health and wellbeing of a patient
  • Another object of the present invention is to provide a system and method for monitoring the heart muscle function of a patient that allows for periodic updates of patient-specific data to provide for a contextual oversight of a heart monitoring protocol.
  • a computer-based system with a contextual oversight capability for monitoring the heart muscle function of a patient.
  • the system includes a sensor array for collecting physiological and environmental data, a context register for storing patient-specific data, and a computer for evaluating all of the collected data from the sensor array in light of data from the context register to determine whether a clinical intervention is warranted.
  • these components will interactively cooperate with each other to assess the overall health and wei!being of a patient.
  • the sensor array of the present invention includes a cardiac sensor for collecting cardiac input data that is pertinent to physiological aspects of a patient. It also includes at least one perturbation sensor for collecting perturbation input data that is pertinent to environmental factors influencing the patient.
  • the cardiac sensor is an electrocardiogram (EKG) and each perturbation sensor is selected from the group consisting of accelerometers, thermometers, audiometers and potentiometers, depending on the needs of the patient.
  • a context register is provided for periodically receiving and storing patient data.
  • the patient data will include medical records of the patient, routine behavioral patterns of the patient, a care plan for the patient, and clinical perceptions recorded by physicians and staff pertinent to the patient needed to maintain a relevant context for the patient. Due to the nature of the patient data, the context register wiil necessarily be configured to periodically receive updated patient data.
  • the computer is provided to receive physiological data input from the cardiac sensor in the sensor array, and to then evaluate this data to identify anomalies.
  • the computer is pre-programmed with a cardio-profile.
  • the cardio-profile establishes predetermined acceptable ranges, R, for variations of individual parameters that are received in the cardiac input data. Accordingly, when an individual parameter in the cardiac input data extends beyond an acceptable range R in the cardio-profile, an anomaly is identified for a physiological factor.
  • the parameters evaluated with the cardio-profile are based on a waveform of the heart muscle, and are selected from the group consisting of: waveform shape characteristics, amplitudes within the waveform, the repetition rate of heart function cycles in the waveform variability of the waveform shape, discontinuities in the waveform and variability of the repetition rate.
  • the computer is also pre-programmed with a response matrix.
  • the response matrix will include a plurality of measurable parameters taken from external influences that have an effect on the patient.
  • each measurable parameter " is assigned a weighting factor, W, according to the influence it may have on the cardiac input data.
  • measurable parameters are selected from the group consisting of a magnitude, a duration, a trend, and a rate of change, together with variations and combinations thereof.
  • An analyzing unit is provided for the computer which includes a first analyzer that receives updated patient data from the context register, and then evaluates the data to determine whether a change order is required to aiter the cardio-profile. If so, at least one of the ranges R for the cardio-profile is appropriately altered.
  • a second analyzer is provided for also receiving updated patient data from the context register to determine whether a change order, based on the updated patient data, is required to a!ter the response matrix, if a change is required, an alteration of at least one of the weighting factors W is made.
  • anomalies identified from the sensor-data, relative to the cardio-profile are compared with aberrations detected in the sensor-data, relative to the response matrix, to determine whether a clinical intervention or further inquiries are warranted.
  • the present invention envisions using a monitoring center to manage ail of the patient-specific data that may be coilected from a plethora of different patients.
  • the patient-specific data will preferably include information obtained from DNA and analyte samples.
  • the monitoring center will, typically, be located at a remote facility where it will directly receive DNA/analyte samples from patients.
  • the monitoring center will a!so be continuously available for electronic communications with the patient.
  • the purpose of the monitoring center is to manage ail of the data that is pertinent to the particular patient.
  • a receiving section, a processor, a classifier and a formatting unit are operated by the monitoring center.
  • the DNA/analyte samples are collected from the patient and segregated into homogeneous groups by a sorting mechanism. There, each DNA/anaiyte sample is identified by type, and it is assigned for further evaluation in accordance with an appropriate, predetermined protocol. The evaluation of each DNA/analyte sampie is then accomplished by a processor which is used at the monitoring center in accordance with the previously identified, predetermined protocol. In particular, for this evaluation, appropriate genome sequencing techniques are performed on the selected DNA/anaiyte sample to identify predictors of disease susceptibility for the particular patient that has provided the DNA/anaiyte sample.
  • a classifier is then used to categorize the identified disease predictor according to the severity of the disease, the time-line for progression of the predicted disease, and the efficacy of available treatments. Additionally, the classifier can be used to assess health risk factors, hereditary tendencies, and drug responses that are important for the patient.
  • the monitoring center also includes a formatting unit for preparing, arranging and formatting the disease predictors as computer input data.
  • the data obtained from DNA/analyte samples are used together with other data pertinent to the patient for collective use in a computer-based system which monitors the heart muscle function of the patient.
  • the data of interest for the present invention includes data pertaining to DNA/analyte samples, physiological aspects of the heart muscle function of the patient, external factors influencing the patient, medical records of the patient, routine behavioral patterns of the patient, a care plan for the patient, and notes regarding perceptions recorded by physicians and clinicai staff pertinent to the patient.
  • Fig. 1 is a schematic presentation of data flow from a patient to a computer in accordance with the present invention
  • Fig. 2 is a schematic presentation of patient-specific data being input into a computer
  • Fig. 3 is a functional diagram of the data manipulation tasks required for an operation of the present invention
  • Fig. 4 is a schematic representation of the interactive system components used for monitoring the heart muscle function of a patient in accordance with the present invention.
  • a patient/user of the present invention is designated 10. As shown, the patient 10 is wearing a sensor array 12 that is connected in communication with a computer 14.
  • the computer 14 can be either worn by the patient 10 together with the sensor array 12, or it can be located at a remote site (not shown).
  • the computer 14 includes a cardio-profile 16, and a response matrix 18, which are both disclosed in detail in U.S. Application Serial No. 15/643,975 which was filed on July 7, 2017 for an invention entitled "Cardiac Monitor with Perturbation Evaluation,” which is incorporated herein by reference, and which is assigned to the same assignee as the present invention (hereinafter referred to as the '975 Application).
  • Fig. 1 also shows that the physiological data is transmitted from the patient 10 to the cardio- profile 16 in computer 14 via a communication link 20, and the data pertaining to external factors influencing the patient 10 is transmitted from the patient 10 to the response matrix 18 in computer 14 via a communication link 22.
  • the cardio-profile 16 is used to evaluate measurable parameters in cardiac input data from the patient 10. To do this, the cardio- profile 16 establishes acceptable ranges R for variations in individual parameters of the cardiac input data. In general, the measurable parameters are based on characteristics in a waveform of the heart muscle of the patient 10. Typically, they are selected from the group consisting of waveform shape characteristics, amplitudes within the waveform, the repetition rate of heart function cycles in the waveform, variability of the waveform shape, discontinuities in the waveform, and variability of the repetition rate. A more detailed disclosure of the cardio-profile is available with reference to the '975 Application.
  • the response matrix 18 includes measurable parameters that are taken from an external influence on the patient 10. Each measurable parameter is then given a weighting factor W according to the nature of its influence on the cardiac input data that is sent to the cardio -profile 16. Typically, measurable parameters are selected from the group consisting of: a magnitude, a duration, a trend, and a rate of change, together with variations and combinations thereof.
  • patient data 24 is provided to a context register 26 via a communication link 28 for use by the computer 14.
  • the context register 26 will periodically receive and store patient data 2.4, including documented material such as medical records of the patient 10, routine behavioral patterns of the patient 10, a care plan for the patient 10, and clinical perceptions recorded by physicians and staff pertinent to the patient 10. This is done to continuously update patient data 24 that will collectively provide information in the patient data 24 that is needed to maintain a relevant context for fhe patient 10.
  • Fig. 3 shows the interactive tasks that are involved when manipulating data in accordance with the present invention.
  • input to the computer 14 includes: physiological data for evaluation by the cardio-profiie 16, data pertaining to external influences affecting the patient 10 for evaluation by the response matrix 18, and patient data 24 to be incorporated into the context register 26 for use in updating the cardio-profile 16 and the response matrix 18.
  • Fig. 3 shows that the updating of the cardio-profiie 16 and the response matrix 18 require separate analyses.
  • an analyzer 30 is used to determine whether patient data 24 in the context register 26 indicates the need for a change order to the cardio-profile 16. If so, this change order will involve an alteration of at least one of the ranges R in the cardio-profiie 16. Specifically, such a change order may be required when an individual parameter in the cardiac input data extends beyond its acceptable range R in the cardio-profile 16.
  • an analyzer 32 is used to determine whether patient data 24 in the context register 26 indicates the need for a change order to the response matrix 18. In this case, a change order for the response matrix 18 involves an alteration of at least one of the weighting factors W.
  • updated patient data 24 for the cardio-profile 16 and the response matrix 18 is respectively provided by the analyzers 30 and 32.
  • a comparator 34 evaluates all of the collected data from the sensor array 12 in light of the pertinent changes that may be evidenced in the updated patient data 24.
  • a report 36 can then be prepared which will indicate whether a clinical intervention is warranted.
  • Fig. 3 also shows that a monitoring center 38 can be connected in communication with the computer 14.
  • the purpose of the monitoring center 38 is to provide an oversight capability for continuously monitoring the interactive functions of the cardio-profile 16 and the context register 26.
  • the monitoring center 38 is connected to the comparator 34 of the computer 14 via a communication link 40.
  • the present invention envisions collecting DNA/analyte samples 50 (including surface analyte samples) from the patient 10 for the purpose of evaluating his/her heart muscle function.
  • the samples 50 can be collected by any means well known in the pertinent art.
  • the use of disposable patches containing electrodes and other collecting components are preferably used when available.
  • the DNA/analyte samples 50 can be of any type well known in the pertinent art, such as skin, nails, hair, saliva, blood, perspiration, mucus, urine, feca! matter and body secretions from the patient 10.
  • the DNA/analyte samples 50 cart be delivered directly to the monitoring center 38 via a communications link 52 by any means known in the art, such as logistic! delivery, mail, hand-carried, or electronic information transfer.
  • the DNA/analyte samples 50 are first separated by a sorting mechanism 54, which segregates the DNA/analyte samples 50 into homogeneous groups for respective evaluation in accordance with a predetermined clinical protocol.
  • a processor 56 is used to perform the predetermined protocol.
  • this requires using genome sequencing techniques on a selected DNA/analyte sample 50, to identify predictors of disease susceptibility for the patient 10 providing the DNA/analyte sample 50.
  • a disease predictor Once a disease predictor has been identified, it is sent to a classifier 58 where it is categorized. Specifically, the identified disease predictor is categorized according to a severity of the disease, a timeline for disease progression, and efficacy of treatment.
  • a formatting unit 60 prepares and arranges the disease predictors as data. This data is then passed via communication link 62 to the context register 26 in the computer 14. The data pertaining to DNA/analyte sample 50 is then used, collectively, with data pertinent to physiological aspects of the patient 10 and externa! factors influencing the patient 10, for preparing the report 36.

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Abstract

La présente invention concerne un système informatique permettant de surveiller une fonction du muscle cardiaque d'un patient, à l'aide d'un contrôle contextuel, qui comprend un réseau de capteurs permettant de collecter des données physiologiques et environnementales qui sont pertinentes pour le patient. On a prévu également un registre de contexte, qui contient des données spécifiques à un patient mises à jour périodiquement, qui établit une capacité de contrôle contextuel pertinent pour le système. Pendant son fonctionnement, un ordinateur identifie des anomalies dans les données physiques et détecte des aberrations dans les données environnementales. Ces anomalies et aberrations sont ensuite évaluées ensemble de manière interactive, par rapport à la capacité de contrôle contextuel, pour déterminer si une intervention clinique pour le patient est garantie.
PCT/US2018/050501 2017-10-03 2018-09-11 Systèmes et procédés informatiques de surveillance du muscle cardiaque d'un patient à l'aide d'un contrôle contextuel Ceased WO2019070375A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US15/724,131 2017-10-03
US15/724,131 US20190034594A1 (en) 2017-07-31 2017-10-03 Computer-based systems and methods for monitoring the heart muscle of a patient with comprehensive contextual oversight

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WO2019070375A1 true WO2019070375A1 (fr) 2019-04-11

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040122787A1 (en) * 2002-12-18 2004-06-24 Avinash Gopal B. Enhanced computer-assisted medical data processing system and method
US20090198519A1 (en) * 2008-01-31 2009-08-06 Mcnamar Richard Timothy System for gene testing and gene research while ensuring privacy
US20100285082A1 (en) * 2003-08-22 2010-11-11 Fernandez Dennis S Integrated Biosensor and Simulation System for Diagnosis and Therapy
US20130029862A1 (en) * 2011-06-02 2013-01-31 Gareth Davies Clinical application utilizing genetic data for effective medication management
US20140012843A1 (en) * 2012-07-06 2014-01-09 Nant Holdings Ip, Llc Healthcare analysis stream management
US20140359422A1 (en) * 2011-11-07 2014-12-04 Ingenuity Systems, Inc. Methods and Systems for Identification of Causal Genomic Variants

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040122787A1 (en) * 2002-12-18 2004-06-24 Avinash Gopal B. Enhanced computer-assisted medical data processing system and method
US20100285082A1 (en) * 2003-08-22 2010-11-11 Fernandez Dennis S Integrated Biosensor and Simulation System for Diagnosis and Therapy
US20090198519A1 (en) * 2008-01-31 2009-08-06 Mcnamar Richard Timothy System for gene testing and gene research while ensuring privacy
US20130029862A1 (en) * 2011-06-02 2013-01-31 Gareth Davies Clinical application utilizing genetic data for effective medication management
US20140359422A1 (en) * 2011-11-07 2014-12-04 Ingenuity Systems, Inc. Methods and Systems for Identification of Causal Genomic Variants
US20140012843A1 (en) * 2012-07-06 2014-01-09 Nant Holdings Ip, Llc Healthcare analysis stream management

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