Abstract: Abstract System and method for remotely reporting Heart Rate Variability Present invention provides a system and method for heart rate variability (HRV) reporting in clinical and community settings. The method segregates the simpler task of raw HRV data collection from the complex task of processing, analysis and report requiring training and expertise. The raw HRV data collection is performed at the point of care / recording center that wirelessly interacts with the remote server. The service backend is typically geographically isolated from point of care. Service backend is accessible to trained human experts for processing, analysis and reporting of HRV data. Tele HRV service thus extends the availability of the HRV data processing and reporting expertize to the remote community locations. Fig. 2 is to be published with abstract.
FORM 2
THE PATENTS ACT-1970
(39 of 1970)
&
The Patent Rules, 2003
COMPLETE SPECIFICATION
(See Section 10 and Rule 13)
1. TITLE OF THE INVENTION
System and method for remotely reporting Heart Rate Variability
2. APPLICANT
a) Name Promorphosis Pvt. Ltd.
b) Nationality Indian company
c) Address G 01, A J Arcade, D P Road, Kothrud, Pune-411038,
Maharashtra (India)
3. PREAMBLE TO THE DESCRIPTION
The following specification describes the invention and the manner in which it is to be performed.
Title
System and method for remotely reporting Heart Rate Variability
Field of Invention
The present invention relates generally to a field of telemedicine.
More particularly, it relates to a system and method of HRV and other vitals data collection at point of care and remotely analysing, processing and reporting HRV (Heart Rate Variability).
Background of Invention
HRV (Heart Rate Variability) computed by analysing beat-to-beat interval time series derived from an ECG (Electrocardiogram) is a convenient non-invasive tool for assessment of cardiac ANS modulation. In 1996, the European Society for Cardiology and the North American Society of Pacing and Electrophysiology supported a Task Force which issued a seminal paper: "Heart rate variability: Standards of measurement, physiological interpretation and clinical use"(Task Force. Heart rate variability: Standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation 1996; 93:1043–1065) A variety of metrics have been proposed for measuring HRV. These metrics can broadly be classified into time, frequency, and nonlinear domain measures of HRV. Careful pre-processing and de-noising of voluminous ECG time series data recorded at high sampling rate are critical for the accuracy of analysis.
The interest in HRV as a measurement of autonomic function lies in its clinical importance: reduced HRV is a powerful and independent predictor of an adverse prognosis in patients with heart disease and in the general population. It has been found to be augmented in the physically fit and diminishes with age. A variety of cardiovascular risk factors and disease states have reduced HRV, the list includes Metabolic syndrome/Insulin resistance, Diabetes, Diabetic neuropathy, Hypertension, smoking, obesity, work stress and heart failure. Alterations,
generally reductions are also found in Myocardial Infarction, Congestive cardiac failure, psychological Stress and psychiatric disorders like depression, mania, panic disorders and sleep disorders. Most studies have reported the degree of alteration in HRV to be correlated with the severity of the pathology. Application of HRV analysis and reporting cannot be overstressed with its use in multiple medical specialities.
HRV has application for diagnostic and research assessment, staging, screening of cardiac autonomic neuropathy and dysfunction in clinical and community settings, for monitoring prediction and prognostication in several medical conditions as well as application as a marker to gauge improvement in clinical trials (of pharmacological and non-pharmacological interventions). Some examples are:
• Anaesthesiology (in both general and local anaesthesia, pre, intra, and post-surgery for assessment of risk and recovery)
• Bariatric surgery (pre and post-operative assessment of autonomic dysfunction)
• Cardiovascular medicine & surgery (early diagnosis and staging of cardiac autonomic neuropathy and autonomic dysfunction, prognosis of myocardial infarction, congestive cardiac failure, cardiomyopathy and valvular pathology etc.)
• Diabetes (autonomic neuropathy and dysfunction in type 2 and type 1 diabetes mellitus, marker of macro and micro-angiopathy and predictor of complications)
• Endocrinology (thyroid and other endocrine pathology)
• Exercise training (training effect, performance assessment in exercise and sports, overtraining)
• Fetal medicine (fetal distress)
• Gastroenterology (irritable bowel, dyspepsia, motility dysfunction)
• Geriatric medicine (frailty, prediction of falls)
• Hypertension
• Intensive care (adult and neonatal intensive and critical care – monitoring and prognosis, early diagnosis of sepsis)
• Neurology, neurosurgery (autonomic neuropathies, Parkinson’s disease, stroke, epilepsy, syncope, functional neurosurgery, spinal injury)
• Neuropsychiatry (depression, severe psychiatric morbidity, anxiety disorders, psychosomatic conditions)
• Obesity & metabolic syndrome (early autonomic dysfunction and neuropathy)
• Obstetrics & gynaecology (prediction of preeclampsia, other pregnancy complications)
• Pain medicine (various organic and functional pain syndromes)
• Respiratory medicine (chronic obstructive pulmonary disease and other respiratory conditions)
• Sexual medicine (assessment of erectile dysfunction and premature ejaculation, and female sexual disorders)
• Sleep medicine (sleep disorders)
• Stress research (measure of stress and wellbeing, workplace wellness)
• Yoga & meditation research (state and trait effect, training effect)
• Special situations like high altitude and deep sea, space travel, etc.
HRV’s significance is further highlighted by the fact many of these conditions e.g. diabetic autonomic neuropathy are asymptomatic in the initial stages (i.e. patient does not experience any symptoms) and early diagnosis is possible only through testing. It has therefore found recommendation for clinical use as well as for research.
Called the new vital by researchers, translation of HRV test from laboratory to clinic and community was however constrained by expensive laboratory devices and analysis software, and complicated data pre-processing and analysis requiring high expertise.
A rapid technological growth has improved the scope of many remote health monitoring systems.
Present invention provides a system and method for remotely analysing, processing and reporting HRV as per standards laid down by Task Force.
The invention provides HRV data acquisition through the ambulatory device which is simple and easily learnable in a few minutes even by a paramedic/health care assistant, and the non-invasive test can be carried out anywhere in the community. Tasks requiring expertise viz. data pre-processing, analysis and reporting are carried out by trained technicians and medical experts on the backend of the cloud service with validated analysis and e-report with ready interpretation is delivered to the user.
The following terms / abbreviations are used in the specification, and have meanings attributed to them as mentioned herein below:
HRV Heart Rate Variability
ECG, EKG Electrocardiogram
CART Cardiac Autonomic Reflex Test
POC Point of Care
Subject Patient at point of care
Object of invention
Main object of present invention is to provide a system for remotely reporting & analysing HRV and other vitals.
Another object of present invention is to provide authentic pre-processing, analysis and reporting method supported by human clinical expertise in accordance with the HRV task force recommendations.
Yet another object of present invention is to make the HRV monitoring test available, accessible and affordable to clinics and communities worldwide in setups where the expertise of pre-processing, analysing and interpreting HRV data may not be available.
Summary of Invention
Present invention describes a system and method for remotely reporting Heart Rate Variability wherein; a system may comprise of a recorder with electrodes for recording HRV grade heart related electronic signals of a subject at point of care at remote location, a microcontroller defining the protocol for data acquisition and data transfer, a remote server for data storing, data managing, data processing, a data pre-processing, data analysis and data reporting modules, a diagnosing, interpreting, certifying module of said report and despatching module for sending electronically generated report to the subject or at point of care.
The method of remotely reporting the Heart Rate Variability (HRV) comprising the steps of; registering the subject into the system, recording the HRV grade heart related electronic signals as per the predetermined protocol, transferring said data to microcontroller, uploading the said data onto the remote server over the internet wherein data is being stored and managed, pre-processing, analysing, generating report by the trained technicians located at Central laboratory/station, diagnosing, interpreting and certifying the said report by the medical practitioners and delivering the prepared report to the subject or point of care electronically.
Brief Description of Drawings
The following description will be better understood when read in conjunction with the appended drawings, in which there is shown one or more of the multiple embodiments of the present invention. It should be understood, however, that the various embodiments of the present invention are not limited to the precise arrangements and instrumentalities shown in the drawings.
Fig. 1: relates to an exemplary workflow of the method of remotely reporting Heart Rate Variability (HRV)
Fig. 2: relates to the exemplary diagrammatic representation of the system remotely reporting Heart Rate Variability (HRV) and interaction between its components and actors
Fig. 3: relates to the exemplary sequence of actions at the point of care / recording center.
Fig. 4: relates to the exemplary manual sequence of actions at the Central station/Lab
Table no. 1 Following table describes the legends used in the drawings and their description:
Legend Legend Description
1 Patient/Subject
2 Data acquisition module
3 Electrodes
4 High sampling rate HRV grade recorder
5 Microcontroller embedded electronic device
6 Wireless transmission module
7 Remote server
8 Analysis & reporting module
9 Internet access devices at central station
10 Certifying & Interpretation module
11 Memory
Detail Description of Drawings
The present invention is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings.
Present invention relates to a system and method for remotely analysing, processing and reporting HRV as per standards laid down by Task Force. The system allows the subject/patient at point of care end to collect the HRV data correlated with other physiologic data and transmit it for further pre-processing, analysis and reporting by expert medical practitioner.
The method of analysing, processing and reporting HRV and other vitals data may carry out from a remote location where processing, analysis and reporting expertise may not be available and thus eliminates a need of expertise at the point of care. The data acquisition of a patient is possible from a remote locations where the medical facilities are not available the method may prove to be a great medical facility.
The system and method of remotely recording, analysing and reporting HRV system specifically highlights the loose connection between the remote server (7) and microcontroller embedded electronic device (5) to demonstrate use of the service at locations where internet connectivity is only intermittently available, making the service uniquely suitable for use at remote community settings.
The method may comprise of a battery-powered ambulatory HRV data acquisition module (2) with plurality of electrodes (3) that records electronic signals at high sampling rate as per HRV Task Force guidelines, a microcontroller (5) to perform different protocols and tests like Cardiac Autonomic Reflex Test (CART) and uploading this and other (vitals, clinical) patient data from any location (point of care) to the remote server (7) where the pre-processing and analysis is carried out as per the HRV Task Force guidelines and other international standards using geographically distributed pool of human experts and e-report is delivered to the point of care / recording center.
Fig 1 illustrates the overall workflow of the method of remotely reporting HRV data covering exemplary action sequence at the point of care end.
The method of remotely recording, analysing and reporting HRV (heart rate variability) as per Task Force guidelines and other international standards using geographically distributed pool of human experts wherein; said method of reporting HRV data may comprising the steps of registering the subject/patient to the system, wiring up the patient/subject (1) with the help of plurality of
electrodes (3) for high sampling rate electronic signals recording, performing action steps as per the test protocol instructed by the microcontroller (5) & monitoring the HRV data acquisition (2).
Subsequent to the said first step, the method may involve transmitting the recorded ECG (electronic waveform) data along with other vitals and clinical data to remote server (7) for further processing analysis and reporting by experts.
Fig 1 also shows the exemplary action sequence performed at the backend of the service.
The system and method of remotely recording, analysing and reporting HRV (heart rate variability) as per Task Force guidelines and other international standards using geographically distributed pool of human experts wherein; the third step may involve the step of pre-processing, interpreting, reporting of uploaded data by analysis & reporting module (8) from geographically diverse locations of central station/laboratory at central station thereby allowing utilization of analysis and reporting (9) expertise in a geographically independent manner.
In one embodiment of the invention said vital and clinical data may include the data but not limited to subject’s physical parameters, Cardiac Autonomic Reflex Test (CART), blood pressure or disease information.
In another embodiment of the invention relates to the system and method of remotely recording, analysing and reporting HRV (heart rate variability) as per Task Force guidelines and other international standards using geographically distributed pool of human experts wherein; said transmission of data to remote server (7) may comprise a wireless transmission of data over the internet by a wireless communication module (6).
Fig 2 illustrates a diagrammatic representation of system of remotely reporting HRV data between various processing modules and actors. A system of remotely recording, analysing and reporting HRV (heart rate variability) as per Task Force
guidelines and other international standards using geographically distributed pool of human experts wherein; a system may comprise of a data acquisition module (2) for receiving patient’s electrical signals (1), a wireless transmission module (6) for transmitting data captured by said data acquisition module (2) to a remote server (7) over the internet, atleast one remote server (7) being connected to internet access devices (9) for pre-processing, interpreting, storing, analysis & reporting of uploaded data at central station and a certifying and interpretation module (10) for certifying the generated report for the patient followed by sending the e-report to point of care/remote location patient.
The system of remotely recording, analysing and reporting HRV (heart rate variability) as per Task Force guidelines and other international standards using geographically distributed pool of human experts wherein; said data acquisition module (2) comprises of plurality of electrodes (3) adapted to be worn by the patient (1) for detecting heart related electronic signals based on electrical activity of patient’s heart during a predefined position of a patient (1), a recorder (4) for receiving & converting said electronic signals into ECG waveform and a microcontroller (5) configured to monitor said recorder (4) for defining a protocol of data acquisition procedure, receiving other health related vital parameters of a patient along with system registration details at point of care location.
In one embodiment of the invention, the system of remotely recording, analysing and reporting HRV (heart rate variability) wherein; said microcontroller (5) may comprise a part of recorder (4) or a separate electronic device embedded with microcontroller (5) wherein ECG waveform data from recorder (4) is visible on device screen & may transferred by wireless means such as Bluetooth, IR, WIFI, Wimax, RFiD etc. to remote server (7).
In one embodiment of the present invention, said remote server (7) may comprises a memory module (11) configured to save patient HRV & other vital data received from said data acquisition module (2).
The microcontroller (5) is configured to monitor the recorder (4) with predefined protocol for recording electronic signals at high sampling rate & other vital information along with registration details.
The system of remotely recording, analysing and reporting HRV (heart rate variability) as per Task Force guidelines and other international standards using geographically distributed pool of human experts wherein; said wireless transmission module (6) wirelessly communicates with remote server (7) for transmitting the patient data from a coupled data acquisition module (2) over the internet.
In another embodiment of the invention, the system of remotely recording, analysing and reporting HRV (heart rate variability) wherein; said remote server (7) may connected to internet access devices (9) for pre-processing, interpreting, storing, analysis & reporting of uploaded data at central station by human experts or technicians.
In another embodiment of the present invention, the invention relates to a system of remotely recording, analysing and reporting HRV (heart rate variability) as per Task Force guidelines and other international standards using geographically distributed pool of human experts wherein; said data pre-processing, data analysis and data reporting modules (8) may located at the central station/lab and operated by human experts or technicians wherein the steps may involve functions such as data storing, converting the recorded data into uniform format, reviewing signal quality, detecting R wave peak, time domain, frequency domain non-linear indices, data editing, and data processing as defined by Task Force guidelines and other international standards for generation of HRV indices and generating report.
In yet another embodiment of the present invention, the invention relates to a system of remotely recording, analysing and reporting HRV (heart rate variability) as per Task Force guidelines and other international standards using geographically distributed pool of human experts wherein; said data diagnosing,
data interpreting and data certifying module (10) may further comprises expert medical practitioners for data diagnosing and data interpretation.
Fig 3 shows the exemplary action sequence performed at the point of care in detail.
In another embodiment of the present invention, the invention relates to a system and method of remotely recording, analysing and reporting HRV (heart rate variability) as per Task Force guidelines and other international standards using geographically distributed pool of human experts wherein; the patient/subject (1) is registered into the service and a unique identifier is assigned to the patient (1) for the purpose of linking the patient to his corresponding recording and subsequent HRV report. The figure further shows the steps involved in performing high sampling rate signal recording following the test protocol. After the recording is complete, the recording is transferred from the data acquisition module (2) to the microcontroller enabled embedded electronic device (5), the point of care user may able to review the recording using the mobile app for ascertaining recording quality. Further step may comprise uploading the ECG data to remote server (7) and completing the action sequence at the point of care.
Fig 4 also shows the exemplary action sequence performed at the remote central station/lab.
The central station comprises of data pre-processing, data analysis and data reporting modules (8) located at the central station/lab and operated by human experts or technicians. The method of data analysis and reporting may comprise the steps like data storing, converting the recorded data into uniform format, reviewing signal quality, detecting R wave peak, time domain, frequency domain non-linear indices, data editing, and data processing for generation of HRV indices and generating report.
In one embodiment of the invention relates to a system and method of remotely recording, analysing and reporting HRV (heart rate variability) as per Task Force guidelines and other international standards using geographically distributed pool
of human experts wherein; said data analysis and data reporting module (8) may comprise human experts/technicians for conducting the task of data analysis and data reporting.
Fig. 4 further illustrates the tasks may performed at central station/lab by expert medical practitioners.
After generating report by the technicians as per the guidelines specified by HRV task force, said report may further follow the data diagnosing, interpreting, certifying module (10). Said data diagnosing, interpreting and data certifying may conducted by the expert medical practitioners at remote locations. The medical practitioners may access the patient data by registering to the system over the remote server (7). The data diagnosing, interpreting and data certifying module (10) may comprise steps like report diagnosis & impression and despatching the e-report to point of care where it is used by the medical practitioner for treatment planning.
In one embodiment, the HRV expert medical practitioner may reserve the recording that is pending reporting, and adds the impressions and clinical diagnosis within a day or two.
Following example illustrates the computational accuracy & standard parameters in HRV analysis using the system of remotely recording, analysing and reporting HRV (heart rate variability) and open source equivalent which does not involve system of remotely recording, analysing & certifying modules.
Methods: Subjects/patients were divided into five young (Y1, Y2, ...., Y5) and five old (O1,O2,….O5) resting in supine position.
Recordings were made for Time Series parameters namely Mean (Mean RR), Standard Deviation(SD-RR), Root Mean Squared Standard Deviation (RMSSD) & Number of pairs of RR peaks with difference more than 50ms (NN50). Frequency Domain Analysis includes Power in the Low Frequency Component (LF), High Frequency Component (HF) and the ratio between the two (LF/HF). The average, absolute difference & percentage difference between the two
recordings is calculated. Number of samples in each record is also mentioned for
comparison.
Observations:
Time Series Parameters
1. Mean of consecutive RR Intervals calculated by both the methods, their
averages and differences.
Subject Samples Open source equivalent system Present HRV
monitoring system Average Abs Difference Percentage Difference
O1 7168 1012 1011.48 1011.74 0.52 0.0514098153
O2 6822 1061.7 1061.77 1061.735 0.07 0.0065927649
O3 7227 1003.4 1003.63 1003.515 0.23 0.022916812
O4 4936 1165.8 1165.28 1165.54 0.52 0.0446244679
O5 5729 1087.1 1087.87 1087.485 0.77 0.0707805161
Y1 8708 829.48 829.64 829.56 0.16 0.0192854732
Y2 7034 1028.7 1028.33 1028.515 0.37 0.0359806677
Y3 7642 951.87 951.69 951.78 0.18 0.0189137219
Y4 5509 1313.7 1312.83 1313.265 0.87 0.0662690524
Y5 6964 1048.7 1047.03 1047.865 1.67 0.1594987727
Correlation Coefficient = 0.99998
2. Standard Deviation of consecutive RR intervals.
Subject Samples Open source equivalent system Present HRV
monitoring system Average Abs Difference Percentage Difference
O1 7168 47.56 48.04 47.8 0.48 0.9991673605
O2 6822 33.94 33.91 33.925 0.03 0.088469478
O3 7227 48.05 48.07 48.06 0.02 0.0416059913
O4 4936 86.9 86.15 86.525 0.75 0.8705745792
O5 5729 42.7 43.23 42.965 0.53 1.2260004626
Y1 8708 92.61 92.61 92.61 0 0
Y2 7034 101.3 101.28 101.29 0.02 0.0197472354
Y3 7642 65.5 65.52 65.51 0.02 0.0305250305
Y4 5509 122.9 123.41 123.155 0.51 0.4132566243
Y5 6964 99.9 99.9 99.9 0 0
Correlation Coefficient =0.99992
3. Root Mean Squared Standard Deviation is a measure of short term changes
Subject Samples Open source equivalent system Present HRV
monitoring system Average Abs Difference Percentage Difference
O1 7168 15.5 15.53 15.515 0.03 0.193174501
O2 6822 15.28 15.35 15.315 0.07 0.4560260586
O3 7227 24.4 24.43 24.415 0.03 0.1227998363
O4 4936 38.3 37.52 37.91 0.78 2.078891258
O5 5729 11.3 11.43 11.365 0.13 1.1373578303
Y1 8708 91.01 91.83 91.42 0.82 0.8929543722
Y2 7034 74.62 74.73 74.675 0.11 0.1471965743
Y3 7642 34.3 34.47 34.385 0.17 0.4931824775
Y4 5509 107.4 107.33 107.365 0.07 0.0652194168
Y5 6964 52.8 53.48 53.14 0.68 1.2715033657
Correlation Coefficient =0.99992
4. The number of pairs of consecutive RR intervals that differ more than 50ms.
Subject Samples Open source equivalent system Present HRV
monitoring system Average Abs Difference Percentage Difference
O1 7168 42 42 42 0 0
O2 6822 36 38 37 2 5.2631578947
O3 7227 4936 5729 8708 7034 7642 5509 6964 231 235 233
614
5.5
4085.5
3168
1040
3677
1922.5 4 1.7021276596
O4
614 614
0 0
O5
5 6
1 16.6666666667
Y1
4077 4094
17 0.4152418173
Y2
3160 3176
16 0.5037783375
Y3
1031 1049
18 1.7159199237
Y4
3667 3687
20 0.5424464334
Y5
1903 1942
39 2.0082389289
Correlation Coefficient = 0.99998
5. Frequency Domain Analysis
1. Power Spectrum Density in Low Frequency range (0.04-0.15 Hz).
Subject
O1 O2 O3 O4 O5 Y1 Y2 Y3 Y4 Y5 Samples
7168 6822 7227 4936 5729 8708 7034 7642 5509 6964 Open source equivalent system Present HRV
monitoring system Average Abs Difference Percentage Difference
334.98 298.43 316.705 36.55 12.2474282076
127.89 122.62 125.255 5.27 4.2978306965
486.48 499.76 493.12 13.28 2.6572754922
837.3 769.4 803.35 67.9 8.8250584871
159.26 153.27 156.265 5.99 3.9081359692
1470.6 1563.75 1517.175 93.15 5.9568345324
1768.5 1776.86 1772.68 8.36 0.470492892
1470.6 1535.33 1502.965 64.73 4.2160317326
2225.9 2174.42 2200.16 51.48 2.3675278925
2254.4 2266.1 2260.25 11.7 0.516305547
Correlation Coefficient = 0.99833
6. Power Spectrum Density in High Frequency range (0.15-0.4 Hz)
Subject
O1 O2 O3 O4 O5 Y1 Y2 Y3 Y4 Y5 Samples Open source equivalent system Present HRV monitorin g system Average Abs Difference Percentage Difference
7168 61.01 58.92 59.965 2.09 3.5471826205
6822 59.07 57.9 58.485 1.17 2.0207253886
7227 150.6 151.11 150.855 0.51 0.3375024816
4936 291.2 285.78 288.49 5.42 1.8965637903
5729 20.13 20.5 20.315 0.37 1.8048780488
8708 3435.9 3454.15 3445.025 18.25 0.5283499559
7034 2001.5 2045.8 2023.65 44.3 2.1654120637
7642 354.5 355.7 355.1 1.2 0.3373629463
5509 2241 2260 2250.5 19 0.8407079646
6964 750.12 746.3 748.21 3.82 0.5118585019
Correlation Coefficient = 0.99996
7. Ratio of Low Frequency to High Frequency Power (LF/HF)
Subject Samples Open source equivalent system Present HRV
monitoring system Average Abs Difference Percentage Difference
O1 7168 5.49 5.07 5.28 0.42 8.2840236686
O2 6822 2.16 2.12 2.14 0.04 1.8867924528
O3 7227 3.23 3.23 3.23 0 0
O4 4936 2.88 2.69 2.785 0.19 7.063197026
O5 5729 7.91 7.48 7.695 0.43 5.7486631016
Y1 8708 0.47 0.47 0.47 0 0
Y2 7034 0.88 0.87 0.875 0.01 1.1494252874
Y3 7642 4.14 4.32 4.23 0.18 4.1666666667
Y4 5509 0.99 0.98 0.985 0.01 1.0204081633
Y5 6964 3 3.04 3.02 0.04 1.3157894737
Correlation Coefficient = 0.99767
Conclusion: It is understood that a correlation coefficient above 0.8 is considered an almost perfect agreement. We have Maximum of ICCC =1 which is perfect agreement and we have Minimum CC= 0.9976 which is extremely well correlated for a minimum observation.
Advantages of invention
Remote HRV reporting solution makes this advanced test available, accessible and affordable to clinics and communities worldwide where processing, analysis and reporting expertize may not be available
The report alerts the medical team to initiate timely treatments to control progression of disease, prevent complications and improve outcomes
An added indication is its utility in Yoga/Wellness set-ups as the test also reflects state of wellbeing.
Claims
We claim
1. A method for remotely reporting Heart Rate Variability (HRV) for early
diagnosis of various disease conditions comprising;
registering a subject/patient (1) to the system along with personal vital
information at a remote location where medical facilities are not easily
accessible,
wiring up the subject (1) with plurality of electrodes (3) for capturing the heart
related electronic signals,
converting electronic signals into electronic waveform & monitoring the
protocol for data acquisition by data acquisition module (2),
transmitting the acquired data via wireless transmission module (6) to a
remote server (7),
processing, analysing and reporting by analysis & reporting module (8) being
connected to plurality of internet access devices (9) at a central station,
wherein; said analysis & reporting module (8) being operated by expert
technicians,
certifying & interpreting said report by remotely available medical
professionals/doctors upon registering into system for providing impression,
clinical diagnosis and prognosis on the patient’s health and
sending the report to corresponding patient electronically via the remote server
(7) and wireless transmission module (6) at remote location where the patient
been appeared for the HRV test.
2. The method for remotely reporting Heart Rate Variability (HRV) for early
diagnosis of various disease conditions as claimed in claim 1 wherein; said
data analysis and reporting step further comprises the steps like data storing,
converting the recorded data into uniform format, reviewing signal quality,
detecting R wave peak, time domain, frequency domain non-linear indices,
data editing, and data processing for generation of HRV indices and report.
3. The method for remotely reporting Heart Rate Variability (HRV) for early diagnosis of various disease conditions as claimed in claim 1 wherein; said data interpreting and data certifying step further comprises the steps like report diagnosis & impression and despatching the e-report to point of care for treatment planning.
4. A system for remotely reporting Heart Rate Variability (HRV), the system comprising:
a data acquisition module (2) for receiving patient’s electrical signals (1), wherein the data acquisition module (2) comprising:
plurality of electrodes (3) adapted to be worn by the patient (1) for detecting heart related electronic signals based on electrical activity of patient’s heart during a predefined position of a patient (1), a high sampling rate HRV grade recorder (4) for receiving & converting said electronic signals into ECG waveform and
a microcontroller (5) configured to monitor said recorder (4) for defining a protocol of data acquisition procedure, receiving other health related vital parameters of a patient along with system registration details at point of care (remote) location, a wireless transmission module (6) for transmitting data captured by said data acquisition module (2) to a remote server (7) over the internet, atleast one remote server (7) being connected to internet access devices (9) for pre-processing, interpreting, storing, analysis & reporting of uploaded data at central station by analysis and reporting module (8)
wherein said analysis and reporting module comprises human expert technicians and, a certifying and interpretation module (10) for certifying the generated report for the patient (1) by remotely located expert medical practitioners or doctors followed by sending the e-report to point of care/remote location patient.
5. The system for remotely reporting Heart Rate Variability (HRV) as claimed in claim 4 wherein, said microcontroller (5) either comprises a part of recorder (4) or a separate electronic device embedded with microcontroller (5) wherein ECG waveform data from recorder (4) is visible on device screen & transferred by wireless means such as Bluetooth, IR, WIFI, Wimax, RFiD etc. to said remote server (7).
6. The system for remotely reporting Heart Rate Variability (HRV) as claimed in claim 4 wherein, said remote server (7) comprises of a memory (11) wherein the patient’s vital data, registration details, e-report, electronic waveform data etc information is stored.
| # | Name | Date |
|---|---|---|
| 1 | 201921004049-ABSTRACT [27-07-2024(online)].pdf | 2024-07-27 |
| 1 | 201921004049-PROVISIONAL SPECIFICATION [01-02-2019(online)].pdf | 2019-02-01 |
| 2 | 201921004049-FER_SER_REPLY [27-07-2024(online)].pdf | 2024-07-27 |
| 2 | 201921004049-POWER OF AUTHORITY [01-02-2019(online)].pdf | 2019-02-01 |
| 3 | 201921004049-FORM FOR STARTUP [01-02-2019(online)].pdf | 2019-02-01 |
| 3 | 201921004049-FORM 3 [27-07-2024(online)].pdf | 2024-07-27 |
| 4 | 201921004049-OTHERS [27-07-2024(online)].pdf | 2024-07-27 |
| 4 | 201921004049-FORM FOR SMALL ENTITY(FORM-28) [01-02-2019(online)].pdf | 2019-02-01 |
| 5 | 201921004049-FORM 4(ii) [30-05-2024(online)].pdf | 2024-05-30 |
| 5 | 201921004049-FORM 1 [01-02-2019(online)].pdf | 2019-02-01 |
| 6 | 201921004049-FER.pdf | 2023-12-01 |
| 6 | 201921004049-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [01-02-2019(online)].pdf | 2019-02-01 |
| 7 | 201921004049-FORM 18 [24-02-2023(online)].pdf | 2023-02-24 |
| 7 | 201921004049-EVIDENCE FOR REGISTRATION UNDER SSI [01-02-2019(online)].pdf | 2019-02-01 |
| 8 | Abstract1.jpg | 2020-03-04 |
| 8 | 201921004049-DRAWINGS [01-02-2019(online)].pdf | 2019-02-01 |
| 9 | 201921004049-ORIGINAL UR 6(1A) FORM 1, FORM 26 & FORM 28-040219.pdf | 2019-06-07 |
| 9 | 201921004049-ORIGINAL UR 6(1A) FORM 1, FORM 3 & FORM 5-020320.pdf | 2020-03-03 |
| 10 | 201921004049-COMPLETE SPECIFICATION [28-02-2020(online)].pdf | 2020-02-28 |
| 10 | 201921004049-PostDating-(22-01-2020)-(E-6-14-2020-MUM).pdf | 2020-01-22 |
| 11 | 201921004049-APPLICATIONFORPOSTDATING [22-01-2020(online)].pdf | 2020-01-22 |
| 11 | 201921004049-CORRESPONDENCE-OTHERS [28-02-2020(online)].pdf | 2020-02-28 |
| 12 | 201921004049-DRAWING [28-02-2020(online)].pdf | 2020-02-28 |
| 12 | 201921004049-FORM 3 [28-02-2020(online)].pdf | 2020-02-28 |
| 13 | 201921004049-ENDORSEMENT BY INVENTORS [28-02-2020(online)].pdf | 2020-02-28 |
| 14 | 201921004049-DRAWING [28-02-2020(online)].pdf | 2020-02-28 |
| 14 | 201921004049-FORM 3 [28-02-2020(online)].pdf | 2020-02-28 |
| 15 | 201921004049-APPLICATIONFORPOSTDATING [22-01-2020(online)].pdf | 2020-01-22 |
| 15 | 201921004049-CORRESPONDENCE-OTHERS [28-02-2020(online)].pdf | 2020-02-28 |
| 16 | 201921004049-COMPLETE SPECIFICATION [28-02-2020(online)].pdf | 2020-02-28 |
| 16 | 201921004049-PostDating-(22-01-2020)-(E-6-14-2020-MUM).pdf | 2020-01-22 |
| 17 | 201921004049-ORIGINAL UR 6(1A) FORM 1, FORM 3 & FORM 5-020320.pdf | 2020-03-03 |
| 17 | 201921004049-ORIGINAL UR 6(1A) FORM 1, FORM 26 & FORM 28-040219.pdf | 2019-06-07 |
| 18 | Abstract1.jpg | 2020-03-04 |
| 18 | 201921004049-DRAWINGS [01-02-2019(online)].pdf | 2019-02-01 |
| 19 | 201921004049-EVIDENCE FOR REGISTRATION UNDER SSI [01-02-2019(online)].pdf | 2019-02-01 |
| 19 | 201921004049-FORM 18 [24-02-2023(online)].pdf | 2023-02-24 |
| 20 | 201921004049-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [01-02-2019(online)].pdf | 2019-02-01 |
| 20 | 201921004049-FER.pdf | 2023-12-01 |
| 21 | 201921004049-FORM 1 [01-02-2019(online)].pdf | 2019-02-01 |
| 21 | 201921004049-FORM 4(ii) [30-05-2024(online)].pdf | 2024-05-30 |
| 22 | 201921004049-FORM FOR SMALL ENTITY(FORM-28) [01-02-2019(online)].pdf | 2019-02-01 |
| 22 | 201921004049-OTHERS [27-07-2024(online)].pdf | 2024-07-27 |
| 23 | 201921004049-FORM 3 [27-07-2024(online)].pdf | 2024-07-27 |
| 23 | 201921004049-FORM FOR STARTUP [01-02-2019(online)].pdf | 2019-02-01 |
| 24 | 201921004049-FER_SER_REPLY [27-07-2024(online)].pdf | 2024-07-27 |
| 24 | 201921004049-POWER OF AUTHORITY [01-02-2019(online)].pdf | 2019-02-01 |
| 25 | 201921004049-PROVISIONAL SPECIFICATION [01-02-2019(online)].pdf | 2019-02-01 |
| 25 | 201921004049-ABSTRACT [27-07-2024(online)].pdf | 2024-07-27 |
| 26 | 201921004049-US(14)-HearingNotice-(HearingDate-11-08-2025).pdf | 2025-07-10 |
| 27 | 201921004049-Correspondence to notify the Controller [09-08-2025(online)].pdf | 2025-08-09 |
| 28 | 201921004049-Written submissions and relevant documents [25-08-2025(online)].pdf | 2025-08-25 |
| 29 | 201921004049-FORM 3 [25-08-2025(online)].pdf | 2025-08-25 |
| 30 | 201921004049-Annexure [25-08-2025(online)].pdf | 2025-08-25 |
| 1 | 201921004049E_30-10-2023.pdf |