Electrocardiographic signal monitoring device and method

• US 10,271,753 B1
• Filed: 05/17/2018
• Issued: 04/30/2019
• Est. Priority Date: 03/14/2018
• Status: Active Grant

• Current Assignee: Medical Wearable Solutions Ltd.
• Original Assignee: Medical Wearable Solutions Ltd.
• Inventors: Sahiholnasab, Vahid, Zahedi, Edmond, Katanbaf Nezhad, Mohamadtaghi, Sahiholnasab, Hossein
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US15/982,874
• Time in Patent Office: 348 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• 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 5/339 Displays specially adapted therefor
• CPC Class Codes: A61B 5/6803 Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/7225 Details of analog processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation A61B5/30, A61B5/316 take precedence; transformers for specific applications H01F38/00; amplifiers H03F
• CPC Class Codes: A61B 5/7232 involving compression of the physiological signal, e.g. to extend the signal recording period
• CPC Class Codes: A61B 5/7235 Details of waveform analysis A61B5/349 takes precedence

Abstract

A device for detecting, monitoring and optionally recording ECG signals is disclosed. The device has at least two electrodes and an on-board memory. The electrodes can be recoatable and/or replaceable. The device can be charged wirelessly through the electrodes or by an internal energy harvesting system. A power saving mode is provided whereby the electrodes are activated by a pre-defined tapping pattern of electrical contact applied by a user and, upon activation, the device starts pairing with and transmitting ECG signals to a receiving station, e.g. a computer, a smart phone, a tablet or the like.

Claims

1. A system for monitoring and recording ECG signals comprising:

a housing defining a compartment that holds a plurality of electrodes, a processing unit, a data storage unit, a power storage unit, and a wireless transceiver unit that communicates with a paired external device;

said housing is portable and includes at least one of an independent use and a use with said paired external device;

said paired external device calculates an anticipated useful lifespan of said plurality of electrodes based on at least one of an age of an electrode, and the number of cycles of ECG data obtained by said electrode;

said plurality of electrodes includes at least two electrodes secured to the housing to obtain an ECG signals from a user and are coated in situ or replaced when the anticipated useful lifespan of electrodes is reached;

said processing unit receives the ECG signals from said electrodes by carrying out at least one of an analog processing, and a digital processing and analyzes the ECG signal to classify a type of ECG abnormality;

said ECG signal is compressed before being sent to said data storage unit, and is compressed and encrypted before sent to said wireless transceiver unit;

said data storage unit has a memory to store the EGC signal that is processed and compressed, and a recorded tapping pattern that includes at least one of a long tapping pattern, and a short tapping pattern;

said long tapping pattern is selected to be long enough that the wireless transceiver is not activated by spurious or random contact of a user'"'"'s fingers with electrodes;

said short tapping pattern is selected to be short enough that said user can easily remember the stored tapping pattern and can execute the stored tapping pattern of electrical contact within a few seconds;

the recorded tapping pattern includes at least one of a predetermined pattern and an applied tapping pattern of electrical contact of the user'"'"'s choosing;

said power storage unit supplies power to the system for monitoring and recording ECG signals and is recharged using at least one of a solar cell, a sound/ultrasound wave charger, and a body movement charger; and

said wireless transceiver unit is activated by detecting said tapping pattern and then communicates with said paired external device and send at least one of a recorded EGC related information, and a real time ECG signal as it is obtained for further analysis and manipulation.

2. A system as defined in claim 1, wherein said housing defining a compartment is within at least one of a first arm, a second arm, and both arms of a pair of eyeglasses.

3. A system as defined in claim 1, wherein the data storage unit comprises a circular memory and is adapted to provide an indication that the circular memory is full.

4. A system as defined in claim 3, wherein the system is configured to receive an indication from a user to overwrite data in the circular memory when the circular memory is full.

5. A system as defined in claim 4, wherein the indication from the user to overwrite data in the circular memory comprises continuing to maintain electrical contact with the at least two electrodes for at least a predetermined period of time, and wherein the system is configured to sense the continued electrical contact with the at least two electrodes for at least the predetermined period of time.

6. A system as defined in claim 1, wherein said power storage unit is recharged using a microelectromechanical system (MEMS) using a piezoelectric material where piezoelectric material transforms mechanical strain energy, e.g. caused by vibrations, to electrical energy that is used to recharge the power storage unit.

7. A system as defined in claim 1, wherein the power storage unit is an ultracapacitor or a supercapacitor.

8. A system as defined in claim 1, comprising an ultra-low power circuit positioned within the compartment, the ultra-low power circuit being configured to measure one of:

i. electrical impedance between the pair of electrodes;

ii. an electrical voltage between the pair of electrodes;

or

iii. saturation of a preamplifier stage

in order to evaluate the define electrical contact.

9. A system as defined in claim 1, wherein the at least two electrodes comprise at least one of stainless steel, a silver-silver chloride, and a polymer-based electrodes that are recoatable and detachable.

10. A system as defined in claim 1, wherein the surface of the electrodes is provided with a plurality of indentations to increase the surface area of the electrodes available for contact with fingers of a user and/or provide a tactile feedback sensation to a user, so that the user knows when his or her fingers are in contact with electrodes.

11. A system as defined in claim 1, wherein the paired external device comprises an application program and is at least one of a computer, a smart phone, a tablet and a wearable unit, wherein the wearable unit optionally comprises eyeglasses.

12. A system as defined in claim 1, wherein the application program provided on said paired external device calculates the anticipated expected lifetime of the electrodes and when the anticipated useful lifespan of the electrodes approaches, a user is given a warning signal by the application program to warn the user that electrodes should be replaced or recoated soon, wherein optionally the anticipated expected lifetime of the electrodes is calculated by evaluating the age of the electrodes and the number of cycles of ECG data obtained by electrodes.

13. A method of acquiring ECG data using a remote ECG monitoring and data storage system comprising the steps of:

receiving ECG signals from at least two electrodes when a finger from a first hand of a user is placed in contact with a first one of the at least two electrodes and a finger from a second hand of a user is placed in contact with a second one of the at least two electrodes;

processing the received ECG signals using an on-board processing unit provided within a compartment defined by a housing of the remote ECG monitoring and data storage system to yield ECG data;

storing the ECG data in a data storage unit provided within the compartment;

compressing the ECG data before storing in a data storage unit;

compressing and encrypting the ECG data before sending to a wireless transceiver unit provided within the compartment;

sending a compressed and encrypted ECG signal to a paired external device using the wireless transceiver;

anticipating a useful lifespan of the electrodes by the paired external device using at least one of an age of the electrodes, and the number of cycles of ECG data obtained by the electrodes; and

as an end of the anticipated useful lifespan of the electrodes approaches, providing a warning indication to a user to indicate that the end of the useful lifespan of the electrodes is approaching and that the electrodes should be replaced or recoated.

14. A method as defined in claim 13, wherein the step of processing the received ECG signals using the on-board processing unit comprises:

analyzing the ECG signals in both the time and frequency domains;

using a low pass filter to limit the system bandwidth; and

/or

using notch filtering to remove powerline interference picked up by the electrodes.

15. A method as defined claim 13 further comprising a step of transmitting the ECG data to a receiving device using a wireless transmission protocol, wherein the step of transmitting the ECG data to the receiving device is initiated by application of a predetermined long or short tapping pattern of electrical contact on the at least two electrodes.

16. A method as defined in claim 13, wherein the step of storing the ECG data in the storage unit comprises evaluating whether the storage unit is full and, if the storage unit is full, requesting an indication from a user to proceed before overwriting a record of ECG data previously stored in the storage unit.

17. A method as defined in claim 16, wherein the indication from the user to proceed comprises a user continuing to maintain electrical contact with the electrodes for at least a predetermined period of time.