System for processing physiological data

• US 9,339,202 B2
• Filed: 06/28/2013
• Issued: 05/17/2016
• Est. Priority Date: 11/03/2009
• Status: Active Grant

• Current Assignee: VivaQuant LLC
• Original Assignee: VivaQuant LLC
• Inventors: Brockway, Marina, Brockway, Brian
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US13/931,228
• Publication Number:
  US 20130289424A1
• Time in Patent Office: 1,054 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0015 characterised by features of the telemetry system
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/6801 specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal

Abstract

Physiological signals such as ECG signals are obtained from a patient. In accordance with one or more embodiments, an apparatus, system and/or method is directed to at least two ECG sensing electrodes that adhere to remote locations on a patient and sense ECG signals from the patient. An amplifier circuit amplifies the sensed ECG signals to provide amplified ECG signals, and a digitizing circuit digitizes the amplified ECG. A computing circuit processes the digitized ECG signals (e.g., by removing noise). A battery powers the aforesaid circuits, and a housing houses the battery and aforesaid circuit. A fastener mechanically fastens and electrically couples the housing to one of the electrodes, and the other electrodes are coupled to the amplifier via a flexible insulated lead wire.

Claims

1. An apparatus comprising:

at least two ECG sensing electrodes configured and arranged to adhere to remote locations on a patient and to sense ECG signals from the patient;

a digitizing circuit configured and arranged to digitize the ECG signals to provide digitized ECG signals;

a computing circuit configured and arranged to process the digitized ECG signals by reducing in-band noise as measured by the ANSI/AAMI EC57;

1998 standard by at least 20 dB with a Quality of Signal Reconstruction of >

95%;

a housing that houses the digitizing circuit and the computing circuit;

a fastener configured and arranged to mechanically fasten the housing to a first one of the ECG sensing electrodes and to electrically couple the first one of the ECG sensing electrodes to the digitizing circuit; and

for each additional one of the at least two ECG sensing electrodes that is in addition to the first one of the ECG sensing electrodes, a flexible insulated lead wire configured and arranged to couple the additional ECG sensing electrode to the digitizing circuit.

2. The apparatus of claim 1, wherein the fastener is configured and arranged to mechanically connect the housing to a first one of the ECG sensing electrodes by affixing the housing to the first one of the ECG sensing electrodes, wherein the computing circuit is configured and arranged to

remove noise from the digitized ECG signals while maintaining morphology of the digitized ECG signal, therein providing denoised ECG signals, and

process the denoised ECG signals by carrying out a function selected from the group consisting of:

detecting an R-R interval, detecting a Q-T interval, detecting a QRS complex, and a combination thereof.

3. The apparatus of claim 1, further including a battery configured and arranged to power the digitizing and computing circuits, wherein the housing also houses the battery, and wherein the first one of the ECG sensing electrodes is configured and arranged to adhere to the patient and to support the entire weight of the housing via the fastener.

4. The apparatus of claim 1, further including an adhering component configured and arranged to adhere and fully support the first one of the ECG sensing electrodes and the housing to the skin of a patient.

5. The apparatus of claim 1, wherein each ECG signal is sampled at 300 Hz or less and the computing circuit is configured and arranged to reduce the in-band noise using an average power consumption that is less than 500 micro-Watts per ECG signal.

6. The apparatus of claim 1 wherein the housing has an average thickness of less than 12 mm and a volume of less than 18 cc.

7. The apparatus of claim 1, wherein the housing includes the first one of the electrodes.

8. The apparatus of claim 1, wherein the housing includes the fastener.

9. The apparatus of claim 1 wherein the flexible insulating lead wires are >

10 cm in length.

10. The apparatus of claim 1 wherein the flexible insulating lead wires are >

15 cm in length.

11. The apparatus of claim 1 wherein the flexible insulating lead wires are <

3 mm diameter.

12. The apparatus of claim 1 further including a coin cell battery configured and arranged to power the digitizing and computing circuits, wherein the housing has a battery compartment configured and arranged to hold the coin cell battery and couple power from the battery to the digitizing and computing circuits, the battery compartment having a threaded cap configured and arranged to secure the coin cell battery therein.

13. The apparatus of claim 1, wherein the digitizing circuit includes an amplifier circuit configured and arranged to amplify the sensed ECG signals to provide amplified ECG signals for digitizing.

14. An apparatus comprising:

at least two ECG sensing electrodes configured and arranged to adhere to remote locations on a patient and to sense ECG signals from the patient;

a digitizing circuit configured and arranged to digitize the ECG signals to provide digitized ECG signals;

a computing circuit configured and arranged to process each digitized ECG signal by

decomposing the signal into subcomponents;

identifying a location of the QRS complex of a cardiac cycle in the ECG signal;

identifying a first time window in the cardiac cycle that includes the QRS complex;

identifying at least one time window in the cardiac cycle that does not include the QRS complex;

for each of the identified time windows, identifying target subcomponents as subcomponents that contain more energy that is within the band of frequencies characteristic of a desired ECG signal in the time window than energy that is outside the band of frequencies of the desired ECG signal; and

reconstructing a denoised physiological signal using at least two of the identified target subcomponents;

a housing that houses the digitizing circuit and the computing circuit;

a fastener configured and arranged to mechanically fasten the housing to a first one of the ECG sensing electrodes and to electrically couple the first one of the ECG sensing electrodes to the digitizing circuit; and

for each additional one of the at least two ECG sensing electrodes that is in addition to the first one of the ECG sensing electrodes, a flexible insulated lead wire configured and arranged to couple the additional ECG sensing electrode to the digitizing circuit.

15. A patient-worn apparatus for recording an ECG from the patient, the apparatus comprising:

a first circuit configured and arranged to digitize an ECG signal obtained from the patient via at least two ECG leads; and

a computing circuit connected to the first circuit to receive the digitized ECG signal, the computing circuit being configured and arranged to

decompose the digitized ECG signal into subcomponents,

compute a statistical variance of the subcomponents over a time interval, and

determine if one of the at least two ECG leads is disconnected from the patient based upon the statistical variance of the subcomponents.

16. The apparatus of claim 15, wherein the computing circuit is configured and arranged to generate a trigger alarm, in response to determining that one of the at least two ECG leads is disconnected, and to communicate the trigger alarm to at least one of the patient and a wireless communication circuit.

17. The apparatus of claim 15, wherein the computing circuit is configured and arranged to determine if all of the at least two ECG leads are disconnected and, in response to determining that all of the at least two ECG leads are disconnected, operate the apparatus in a low-power mode.

18. The apparatus of claim 15, wherein the time interval ranges from 10 seconds to 60 seconds.

19. The apparatus of claim 15, further including determining if at least one of the at least two leads is in poor contact with the patient based on the computed statistical variance.

20. An apparatus comprising:

a first sensing electrode configured and arranged to adhere to a patient and to sense physiological signals from the patient;

a denoising component coupled to the first sensing electrode and configured and arranged to receive the sensed physiological signals via the coupling to the first sensing electrode and coupling to a second sensing electrode, the denoising component including

a digitizing circuit configured and arranged to digitize the signals,

a computing circuit configured and arranged to process the digitized signals to remove noise therefrom while maintaining morphology of the physiological signals by reducing in-band noise as measured by the ANSI/AAMI EC57;

1998 standard by at least 20 dB with a Quality of Signal Reconstruction of >

95%,

a battery configured and arranged to power the digitizing and computing circuits, and

a housing configured and arranged to house the battery, digitizing circuit and computing circuit; and

a fastener configured and arranged to mechanically fasten the housing to the first sensing electrode, the first sensing electrode being configured and arranged to support the weight of the denoising component via the fastener while the first sensing electrode is adhered to the patient.

21. An apparatus comprising:

at least two ECG sensing electrodes configured and arranged to adhere to remote locations on a patient and to sense ECG signals from the patient;

a digitizing circuit configured and arranged to digitize the ECG signals to provide digitized ECG signals;

a computing circuit configured and arranged to;

decompose the digitized ECG signal into subcomponents,

compute a statistical variance of the subcomponents over a time interval, and

determine if one of the at ECG sensing electrodes is disconnected from the patient based upon the statistical variance of the subcomponents;

a housing that houses the digitizing circuit and the computing circuit;

a fastener configured and arranged to mechanically fasten the housing to a first one of the ECG sensing electrodes and to electrically couple the first one of the ECG sensing electrodes to the digitizing circuit; and

for each additional one of the at least two ECG sensing electrodes that is in addition to the first one of the ECG sensing electrodes, a flexible insulated lead wire configured and arranged to couple the additional ECG sensing electrode to the digitizing circuit.