Programmable ECG sensor patch

• US 8,688,189 B2
• Filed: 05/17/2005
• Issued: 04/01/2014
• Est. Priority Date: 05/17/2005
• Status: Active Grant

• Current Assignee: Cardiovu Incorporated
• Original Assignee: Cardiovu Incorporated
• Inventors: Shennib, Adnan
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US11/131,574
• Publication Number:
  US 20060264767A1
• Time in Patent Office: 3,241 Days
• Field of Search: 600/382, 600/384, 600/386, 600388-394
• US Class Current: 600/382
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• 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

Abstract

The invention provides a disposable programmable ECG sensor patch for the non-invasive detection of risk patterns according to programmed criteria. The patch is programmed by a medical professional to select one or more monitoring parameters for detection and alarm indication. One application is to detect changes in the ECG due to cardioactive drugs. Another application is triggering an alarm for a cardiac patient during a stress condition. The programmable patch operates in conjunction with an external programming unit for selecting the detection monitoring parameters.

Claims

1. A disposable programmable cardiac test patch that performs non-invasive monitoring of a person'"'"'s ECG, comprising:

a self adhering surface of said patch that secures said patch to a selected location on the body of said person;

a battery;

at least two electrodes that directly electrically contact the person'"'"'s skin at said location and that receive surface ECG signals therefrom when said patch is secured at said location;

a waterproof adhesive that adheres said patch to said person'"'"'s skin for long term wear thereon;

an amplifier electrically coupled to said electrodes for amplifying said received ECG signals;

a processor that is programmed to perform real-time ECG signal processing and further performs signal averaging of a periodic ECG segment for enhancing details of said received ECG signals to enable detection of subtle changes in said person'"'"'s ECG signal pattern that result from said person taking a cardioactive medication;

a memory coupled to said processor for storing at least one programmable monitoring parameter for processing by said processor;

means for customizing said at least one programmable monitoring parameter to said person or to an individual group that is being monitored, said customization being performed by any of a physician, a clinician, or a medical researcher; and

means that receive a wireless programming signal, representing said at least one programmable monitoring parameter, from an external programming device and that load said wireless programming signal representing said at least one programmable monitoring parameter into said memory; and

a flexible, unitary substrate that incorporates said amplifier, said processor, said battery, said memory, and said electrodes into said patch;

wherein said patch has a thickness of less than 3.0 mm.

2. The programmable patch of claim 1 further comprising an indicator that indicates the occurrence of a detected risk pattern.

3. The programmable patch of claim 2, wherein said detection of a risk pattern includes measurement of ECG segment baseline and comparison with a prior ECG segment baseline.

4. The programmable patch of claim 1 further comprising means that wirelessly transmit cardiac data to an external reporting device via a wireless signal.

5. The programmable patch of claim 4, wherein said reporting device is a printer.

6. The programmable patch of claim 4, wherein said wireless signal includes any of infrared signal or radio frequency signal.

7. The programmable patch of claim 1 wherein said monitoring parameter represents any of heart rate, heart rate variability, arrhythmia, syncope episode, block, ECG segment position, ECG segment interval and monitoring duty cycle profile.

8. The programmable patch of claim 1 further comprising a switch that records a cardiac event felt by said person wearing said patch.

9. The programmable patch of claim 1, wherein said patch is waterproof and air-permeable for extended wear exceeding 7 days.

10. The programmable patch of claim 1, wherein said patch alerts a cardiac patient of a cardiac risk during physical activity including exercise.

11. The programmable patch of claim 1, wherein said patch monitors the performance of an implanted cardiac control device.

12. A disposable cardiac monitor patch for continuous wear on a selected location on the body of a person taking a cardioactive drug and that performs non-invasive monitoring of said person'"'"'s ECG and evaluation of the cardiac effect of said cardioactive drug on said person, said patch comprising:

a waterproof self adhering surface of said patch that secures said patch to a selected location on the body of said person for long term wear thereon;

a battery;

at least two electrodes that directly electrically contact the person'"'"'s skin at said location and that receive surface ECG signals therefrom when said patch is secured at said location;

an amplifier electrically coupled to said electrodes that amplifies said received ECG signals;

a processor that is programmed to respond to the amplified ECG signals that performs real-time ECG waveform processing and ECG waveform analysis of said amplified ECG signals, and that further performs signal averaging of periodic ECG segments for enhancing the details of said ECG signals to enable detection of a subtle changes in said person'"'"'s ECG signal patterns according to at least one programmable monitoring parameter that is specifically selected and programmed for said person, or an individual group being evaluated; and

means for programming said at least one programmable monitoring parameter wirelessly into said processor by any of a physician, a clinician, or a medical researcher to detect changes in said person'"'"'s ECG patterns resulting from said person taking said cardioactive drug.

13. The test patch of claim 12, further comprising means that receive a wireless programming signal from an external programming device to configure said at least one monitoring parameter for detecting changes in ECG patterns.

14. The test patch of claim 12 further comprising an indicator transducer that alerts to a detected risk pattern in the ECG.

15. The test patch of claim 12 further comprising means that record the ECG within memory integrated within said patch and that provide wireless playback of said recorded ECG.

16. The test patch of claim 12, wherein said processor is programmed to operate at a selected duty cycle profile.

17. A disposable programmable cardiac test patch that performs non-invasive ECG monitoring of a person who is implanted with a cardiac implant device, said patch comprising:

a waterproof self adhering surface of said patch that secures said patch to the chest area of said person for extended wear thereon of least one week;

an anti-microbial agent incorporated in the skin contact material of said cardiac patch to prevent contamination of the skin contact area and infection of the skin during said extended wear;

a battery;

at least two electrodes that directly electrically contact the person'"'"'s skin at said chest area and that receive surface ECG signals directly therefrom when said patch is secured at said chest area;

an amplifier electrically coupled to said electrodes for amplifying said received ECG signals;

a processor that is programmed to respond to the amplified ECG signals and that detects a risk pattern according to at least one programmable monitoring parameter;

a memory coupled to said processor that stores programming for said processor and said at least one programmable monitoring parameter;

means for said at least one programmable parameter being selected and programmed into said memory by any of a physician, clinician, and a medical research according to the monitoring needs of said person or an individual group being monitored; and

means that receive a wireless programming signal, representing said at least one programmable monitoring parameter, from an external programming device and that load said wireless programming signal into said memory.

18. A method of non-invasive cardiac monitoring of a person implanted with a cardiac control device, comprising the steps of:

a) applying a self-adhered cardiac patch comprising;

two or more electrodes that directly electrically contact said person'"'"'s skin surface and that receive a surface ECG signal directly therefrom;

an amplifier that amplifies said ECG signals from said electrodes;

a processor that is programmed to perform analysis of said amplified ECG signals;

a memory that stores programming for said processor and at least one monitoring parameter;

b) selecting said at least one monitoring parameter by any of a physician, clinician, and a medical researcher according to the monitoring needs of said subject or an individual group being monitored;

c) sending a wireless programming signal, representing any of said at least one monitoring parameter, from an external programming device and loading thereof into said memory;

d) monitoring the ECG by said processor according to said at least one monitoring parameter;

e) detecting a risk pattern of the subject'"'"'s ECG according to said at least one monitoring parameter.

19. The method of claim 18 further comprising the step of indicating a detected risk condition through an indicator integrated within said patch.

20. A device-implemented method of non-invasively monitoring the ECG signal of a subject with a device comprising a programmable patch adhered to the subject'"'"'s body at a location suitable for said monitoring, comprising the steps of:

a) selecting one or more ECG monitoring parameters by any of a physician, clinician, or a medical researcher for programming into said programmable patch according to the monitoring need of said subject or an individual group being monitored;

b) storing said at least one or more ECG monitoring parameters in a programmable patch memory, wherein said one or more parameters is representative of a risk pattern in an ECG signal that is indicative of a cardiac effect of a cardiac drug on said subject;

c) performing signal averaging of periodic ECG segments and differential measurements of the ECG signal in said patch over an extended period of time; and

d) detecting from said signal-averaged differential ECG measurements the occurrence of a risk pattern, according to said at least one stored ECG monitoring parameter.

21. The device-implemented method of claim 20, further including the step of indicating the occurrence of said detected risk pattern to at least one of said subject, a remote observer, and a remote recorder.