WO2019070375A1

WO2019070375A1 - Computer-based systems and methods for monitoring the heart muscle of a patient with comprehensive contextual oversight

Info

Publication number: WO2019070375A1
Application number: PCT/US2018/050501
Authority: WO
Inventors: Paul M. Diperna; Jr. Freeman H. Rose; Adam S. Colton
Original assignee: National Cardiac Inc
Current assignee: National Cardiac Inc
Priority date: 2017-10-03
Filing date: 2018-09-11
Publication date: 2019-04-11
Anticipated expiration: 2020-04-03

Abstract

A computer-based system for monitoring the heart muscle function of a patient, with contextual oversight, includes a sensor array for collecting physiological and environmental data that are pertinent to the patient. A context register is also included which contains periodically updated patient-specific data that establishes a relevant contextual oversight capability for the system. In operation, a computer identifies anomalies in the physical data and detects aberrations in the environmental data. These anomalies and aberrations are then interactively evaluated together, relative to the contextual oversight capability, to determine whether clinical intervention for the patient is warranted.

Description

COMPUTER-BASED SYSTEMS AND METHODS FOR MONITORING THE HEART MUSCLE OF A PATIENT WITH COMPREHENSIVE CONTEXTUAL OVERSIGHT

This application is a continuation-in-part of Application Serial No. 15/665,020, filed July 31, 2017, which is currently pending. The contents of Application Serial No. 15/665,020 are incorporated herein by reference.

FIELD OF THE INVENTION

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.

BACKGROUND OF THE INVENTION

It is well known that there is a plethora of different types of sensors which can detect or measure physical phenomena. Each sensor is specifically designed to make a particular measurement, although the measurement itself may be used for different purposes. Moreover, if is well known that an array of different sensors can be used to simultaneously measure different aspects of a single entity from different perspectives (e.g. speed, fuel level and engine oil temp of an automobile). It is an altogether different matter, however, when several different sensors need to be collectively and interactively considered electronically to develop a consensus, or determine a particular course of action, which simply cannot be done by a single sensor. With the above in mind, consider the situation that is presented when it is desirable, or necessary, to monitor and evaluate the heart muscle function of a patient. In overview, a thorough and comprehensive protocol for monitoring and evaluating a patient's heart muscle requires the collective consideration of physiological factors, environmental factors and contextual matters. Further, to be truly meaningful, a consideration of these factors also requires an evaluation of how they interact with each other.

It is well known that an electrocardiogram (EKG) 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.

in addition to the physiological factors that can be measured by an EKG (i.e. heart muscle waveform parameters), it is known that environmental factors (i.e. external influences) can also significantly affect the waveform of a patient's heart muscle function. For instance, temperature, weather conditions, trauma, time of day and situational perceptions are all environmental factors that may necessarily need to be taken into account. These external influences, however, cannot be detected by an EKG, per se. Moreover, environmental factors tend to be episodic and of relatively short duration. Nevertheless, their effect on the heart muscles can have long lasting consequences. In any event, sensors, other than an EKG, such as accelerometers, thermometers, audiometers and potentiometers, are more appropriate for measuring and detecting the impact of environmental factors. in addition to the above, the overall general health and welibeing of a patient will also affect his/her heart muscle function. Thus, 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.

There is one aspect of patient-specific data, however, that does not require frequent updating, but which can provide long-term valuable information. This data pertains to a patient's DNA and various analytes. It is now well known that DNA/analyte samples from a patient can be analyzed using genome sequencing techniques to identify predictors of a person's disease susceptibility. Further, along with disease susceptibility, predictors and analytes can also be used to evaluate a patient's long term wellbeing.

Typically, 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.

For purposes of the present invention, the results of a DNA/analyte analysis, together with pertinent commercially available information on medication labels and pamphlets, such as prescribed drug use regimens, dosages, and avoidance of known adverse side effects, can be useful for supplementing other data relative to a patient's heart muscle function. In particular, all of this information can be formatted as data for input to a computer-based system.

In light of the above, it is 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. Still, another object of the present invention to provide a system and method for monitoring the heart muscle function of a patient that is easy to use, is simple to incorporate, and is comparatively cost effective.

SUMMARY OF THE INVENTION

In accordance with the present invention, a computer-based system is provided with a contextual oversight capability for monitoring the heart muscle function of a patient. In combination 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. As envisioned for the present invention, these components will interactively cooperate with each other to assess the overall health and wei!being of a patient.

With regard to the sensor array of the present invention, it 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. Preferably, 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. In addition to the sensor array, a context register is provided for periodically receiving and storing patient data. In detail, 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.

For an operation of the present invention, 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. For this evaluation purpose, the computer is pre-programmed with a cardio-profile. In particular, 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. For purposes of the present invention, 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.

In addition to the cardio-profile disclosed above, the computer is also pre-programmed with a response matrix. Specifically, the response matrix will include a plurality of measurable parameters taken from external influences that have an effect on the patient. In the response matrix, each measurable parameter^" is assigned a weighting factor, W, according to the influence it may have on the cardiac input data. For the present invention, 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. Similarly, 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. In the event, based on updated patient data from the context register, 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.

As an additional consideration for a computer-based system which will monitor the heart muscle function of a patient, 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. An important aspect of this consideration is that the patient-specific data will preferably include information obtained from DNA and analyte samples.

In accordance with the present invention, 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. In this arrangement, the purpose of the monitoring center is to manage ail of the data that is pertinent to the particular patient. To do this, a receiving section, a processor, a classifier and a formatting unit are operated by the monitoring center.

At the receiving section of 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. Once a disease predictor has been identified, 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.

In combination with the components disclosed above, the monitoring center also includes a formatting unit for preparing, arranging and formatting the disease predictors as computer input data. Importantly, 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. Accordingly, 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.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which;

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; and 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.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring initially to Fig. 1 , 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. For purposes of the present invention, 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).

As shown in Fig. 1, 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.

For purposes of the present invention, 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. Like the cardio-profiie 16, a more detailed disclosure of the response matrix 18 is also available with reference to the '975 Application, tn essence, 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.

In Fig. 2 it is shown that, in addition to input for the cardio-profile 16 and the response matrix 18, patient data 24 is provided to a context register 26 via a communication link 28 for use by the computer 14. in particular, as intended for the present invention, 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.

An operation of the present invention will be best appreciated with reference to Fig. 3 which shows the interactive tasks that are involved when manipulating data in accordance with the present invention. As shown in Fig. 3, 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.

In detail, Fig. 3 shows that the updating of the cardio-profiie 16 and the response matrix 18 require separate analyses. For one, 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. For another, 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.

Still referring to Fig. 3, it will be seen that 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 then 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.

In addition to the features disclosed above for the present invention, 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. As shown in Fig. 3, the monitoring center 38 is connected to the comparator 34 of the computer 14 via a communication link 40.

Turning now to Fig. 4, it will be seen that 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. As envisioned for the present invention, the samples 50 (DNA and analyte) can be collected by any means well known in the pertinent art. In particular, the use of disposable patches containing electrodes and other collecting components are preferably used when available. As is well known, 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. For purposes of the present invention, 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 parce! delivery, mail, hand-carried, or electronic information transfer.

At the monitoring center 38, 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. Next, a processor 56 is used to perform the predetermined protocol. Typically, 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. 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. With this information, 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.

While the particular Computer-Based Systems and Methods for Monitoring the Heart Muscle of a Patient with Comprehensive Contextual Oversight as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages herein before stated, it is to be understood that it is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended to the details of construction or design herein shown other than as described in the appended claims.

Claims

What is claimed is:

1. A monitoring center for managing data pertinent to a patient which comprises:

a receiving section for collecting DNA/analyte samples from the patient;

a sorting mechanism for segregating the DNA/analyte samples into homogeneous groups for respective evaluation of each DNA/analyte sample from a selected group in accordance with a predetermined protocol;

a processor for performing the predetermined protocol, using genome sequencing techniques on a selected DNA/analyte sample, to identify predictors of disease susceptibility for the patient providing the DNA/analyte sample;

a classifier for categorizing the identified disease predictors according to a severity of the disease, a time-line for disease progression, and efficacy of treatment; and

a formatting unit for preparing, arranging and formatting the disease predictors as data, together with other data pertinent to the patient, for collective use in a computer-based system for monitoring the heart muscle function of the patient.

2. The monitoring center recited in claim 1 wherein predictors of the disease include health risk factors, hereditary tendencies, and drug responses.

3. The monitoring center recited in claim 1 wherein the DNA/analyte samples include skin, nails, hair, saliva, blood, perspiration, mucus, urine, fecal matter and body secretions.

4. The monitoring center recited in claim 1 wherein the computer- based system comprises:

a cardio-profile manifesting physiological aspects of the heart muscle function of the patient;

a response matrix manifesting external factors influencing the patient; and

a context register for storing patient data, wherein the patient data includes 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 clinical staff pertinent to the patient.

5. The monitoring center recited in claim 4 wherein the data based on categorized disease predictors by the formatting unit is used as input for the context register.

6. The monitoring center recited in claim 5 wherein disease predictors formatted and organized by the monitoring center are used as input to the context register, and each disease predictor is given a respective weighting factor W according to the influence the disease predictor may have on the cardio-profile.

7. The monitoring center recited in claim 6 wherein the weighting factor for a disease predictor accounts for commercially available information, to include drug use regimen, dosage, and avoidance of known adverse side effects.

8. A monitoring center for managing data pertinent to a patient which comprises:

a receiving section for collecting DNA/analyte samples from the patient;

a sorting mechanism for segregating the DNA/analyte samples into homogeneous groups for respective evaluation of each DNA/analyte sample from a selected group in accordance with a predetermined protocol; and

a computer including a processor for performing the predetermined protocol to identify predictors of disease susceptibility for the patient; a classifier for categorizing the identified disease predictors; and a formatting unit for preparing the categorized disease predictors as patient data for collective use with data pertinent to physiological aspects of the patient and external factors influencing the patient, for monitoring the heart muscle function of the patient.

9. The monitoring center recited in claim 8 wherein the predetermined protocol is performed using genome sequencing techniques on a selected DNA/analyte sample.

10. The monitoring center recited in claim 9 wherein the classifier categorizes the identified disease predictors according to a severity of the disease, a time-line for disease progression, and efficacy of treatment.

11. The monitoring center recited in claim 10 wherein categorizing a disease predictor accounts for commercially available information, to include drug use regimen, dosage, and avoidance of known adverse side effects.

12. The monitoring center recited in claim 8 wherein predictors of the disease include health risk factors, hereditary tendencies, and drug responses.

13. The monitoring center recited in claim 8 wherein the DNA/analyte samples include skin, nails, hair, saliva, blood, perspiration, mucus, urine, fecal matter and body secretions.

14. The monitoring center recited in claim 8 wherein the patient data further includes 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 clinical staff pertinent to the patient.

15. A non-transitory, computer-readable medium having executable instructions stored thereon that direct a computer system to perform a process for monitoring the heart muscle function of a patient, the medium comprising instructions for:

receiving input pertinent to DNA/analyte samples from the patient;

segregating the DNA/analyte samples into homogeneous groups for respective evaluation of each DNA/analyte sample from a selected group in accordance with a predetermined protocol;

performing the predetermined protocol to identify predictors of disease susceptibility for the patient;

categorizing the identified disease predictors; and

formatting the categorized disease predictors as patient data for collective use with other data pertinent to physiological aspects of the patient and external factors influencing the patient, for monitoring the heart muscle function of the patient.

16. The medium recited in claim 15 wherein the predetermined protocol is performed using genome sequencing techniques on a selected DNA/analyte sample.

17. The medium recited in claim 16 wherein the classifier organizes the identified disease predictors according to a seventy of the disease, a timeline for disease progression, and efficacy of treatment, while accounting for commercially available information, to include a drug use regimen, dosage, and avoidance of known adverse side effects.

18. The medium recited in claim 15 wherein predictors of the disease include health risk factors, hereditary tendencies, and drug responses.

19. The medium recited in claim 15 wherein the DNA/analyte samples include skin, nails, hair, saliva, blood, perspiration, mucus, urine, fecal matter and body secretions.

20. The medium recited in claim 15 wherein the patient data further includes 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 clinical staff pertinent to the patient.