Systems for safe and remote outpatient ECG monitoring

• US 9,846,764 B2
• Filed: 04/29/2016
• Issued: 12/19/2017
• Est. Priority Date: 10/14/2005
• Status: Active Grant

• Current Assignee: Medicalgorithmics S.A.
• Original Assignee: Medicalgorithmics S.A.
• Inventors: Dziubinski, Marek, Piotrowicz, Ryszard, Piotrowicz, Ewa, Baranowski, Rafal
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US15/143,281
• Publication Number:
  US 20160246937A1
• Time in Patent Office: 599 Days
• Field of Search: 600523
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/364 Detecting abnormal ECG interval, e.g. extrasystoles, ectopic heartbeats
• CPC Class Codes: A61B 5/366 Detecting abnormal QRS complex, e.g. widening
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A system and method providing outpatient ECG monitoring and safe home based cardiac tele-rehabilitation. The system includes a recordation module for recording ECG signals using at least one lead, a tele-rehabilitation module for home based exercise management for a patient'"'"'s recovery, the tele-rehabilitation module including a processing module for recognizing erroneous data from the ECG signals and an analysis module for calculating beat-to-beat annotations and determining if an ECG event and/or if a QT interval duration change has occurred. The system can include an exercise module for guiding the patient during an exercise session, a visual display that informs the patient to start and/or to stop the tele-rehabilitation exercise, a visual display and/or audible signal that informs the patient of an incoming or a missed tele-rehabilitation exercise session, and/or a communication module for transmitting/receiving data between the a cardiac tele-rehabilitation module and a physician/monitoring center.

Claims

1. A remote system for recording and processing ECG signals from a patient for transmission to medical personnel, the system comprising:

an ECG digitization and wireless transmission (DWT) device configured to record real-time ECG signals using a single lead;

a tele-rehabilitation module operably coupled to the ECG DWT device and configured to receive patient input of patient information that includes at least one of the following;

physical and mental condition, stress information, mood information, pharmacotherapy information, patient condition information, and perceived symptom based event;

a processing module operably coupled to the tele-rehabilitation device and comprising limited-lead signal analysis circuitry configured to recognize erroneous signals and reduce noise in the ECG signals;

an analysis module operably coupled to the processing module and comprising circuitry configured to generate beat-to-beat annotations and automatically detect events in the ECG signals; and

an ECG transceiver operably coupled to the system and configured to transmit all gathered information to a remote monitoring module, the remote monitoring module including circuitry configured to provide a visualization, in real-time, waveforms of the ECG signals, annotations, patient information, noise, and erroneous signals.

2. The system of claim 1, wherein the processing module is further configured for constant monitoring and analysis of the patient'"'"'s ECG signals.

3. The system of claim 1 wherein the ECG transceiver employs a communications protocol designed to allow a specialist to simultaneously monitor a large group of patients.

4. The system of claim 1, wherein the tele-rehabilitation module is further configured to receive patient input to send an ECG fragment related to the perceived symptom based event to a doctor.

5. The system of claim 1,

wherein the single lead includes a first electrode and a second electrode;

and

wherein the ECG DWT device is configured to operate on a single channel that includes a signal from the first electrode and a signal from the second electrode.

6. The system of claim 1, wherein the ECG DWT device is also configured to operate on a multi-channel signal that includes signals from three or more electrodes.

7. The system of claim 1, further comprising a control module operable connected to the remote monitoring module and comprising circuitry configured to remotely re-configure settings of the limited lead analysis circuitry.

8. A method for remote recording and processing ECG signals from a patient for transmission to medical personnel, the method comprising:

recording, using an ECG digitization and wireless transmission (DWT) device real-time ECG signals, wherein the recording module is operable using a single lead;

receiving, via a tele-rehabilitation module operably coupled to the ECG DWT device, input of patient information that includes at least one of the following;

physical and mental condition, stress information, mood information, pharmacotherapy information, patient condition information, and perceived symptom based event;

using a processing module operably coupled to the tele-rehabilitation device and comprising limited-lead signal analysis circuitry, recognizing erroneous signals and reducing noise in the ECG signals;

using an analysis module operably coupled to the processing module, generating beat-to-beat annotations and automatically detecting events in the ECG signals;

transmitting, via an ECG transceiver, all gathered information to a remote monitoring module; and

providing a visualization, in real-time and via the remote monitoring module, of waveforms of the ECG signals, annotations, patient information, noise, and erroneous signals.

9. The method of claim 8, further comprising constantly monitoring and analyzing, via the processing module, the ECG signals.

10. The method of claim 8 further comprising employing, via the ECG transceiver, a communications protocol designed to allow a specialist to simultaneously monitor a large group of patients.

11. The method of claim 8 further comprising receiving, via the tele-rehabilitation module, patient input to send an ECG fragment related to the perceived symptom based event to a doctor.

12. The method of claim 8 further comprising:

recording, via the ECG DWT device, the ECG signals on a single channel that includes a signal from a first electrode and a signal from a second electrode, wherein the single lead includes the first electrode and the second electrode.

13. The method of claim 8, further comprising recording, using the ECG DWT device, the ECG signals, on a multi-channel signal that includes signals from a multiple leads, the multiple leads including three or more electrodes.

14. The system of claim 8, further comprising remotely re-configuring, via a control module operable connected to the remote monitoring module, settings of the limited lead analysis circuitry in response to receiving all the gathered information.