Disposable extended wear heart monitor patch

• US 20060224072A1
• Filed: 03/31/2005
• Published: 10/05/2006
• Est. Priority Date: 03/31/2005
• Status: Abandoned Application

• Current Assignee: Cardiovu Incorporated
• Original Assignee: Cardiovu Incorporated
• Inventors: Shennib, Adnan
• Application Number:
  US11/095,821
• Publication Number:
  US 20060224072A1
• Time in Patent Office: Days
• US Class Current: 600/509
• 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 5/6833 Adhesive patches

Abstract

The invention provides a disposable sensor patch for non-invasive monitoring and recording of infrequent cardiac events. The patch is thin and flexible for comfortable wear on the person'"'"'s chest for automatic analysis and recording of ECG. The patch is inexpensive and simple for self-administration. The patch incorporates a battery, ECG amplifier, and a processor for analyzing ECG waveform and recording events. A software algorithm searches for a cardiac abnormality. The patch is designed for continuous long-term wear exceeding 3 days for diagnostic monitoring and exceeding 14 days for event detection. In one embodiment a preformatted report is automatically generated by the patch for wireless transmission to a reporting device such as a generic printer or a wireless network system. The patch may also incorporate a marker switch to correlate recorded ECG data with the patient'"'"'s perception of a cardiac event.

Claims

1. A disposable patch for non-invasive long term continuous monitoring of a patient'"'"'s ECG, comprising:

a self adhering surface of said patch for securing said patch to a selected location on the body of a patient being evaluated for a heart abnormality;

a battery;

at least two electrodes for contacting the patient'"'"'s skin at said location to receive surface ECG signals, when said patch is secured at said location;

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

a signal processor responsive to the amplified ECG signals for detecting one or more cardiac events therefrom;

a memory coupled to said processor for recording the patient'"'"'s ECG at least during each of the detected cardiac events;

waterproofing to seal said patch against penetration of fluids to electrical components thereof to allow said patch to be worn continuously by the patient for at least 14 days including during bathing; and

a transmitter for wireless transmission of the recorded ECG to a remote reporting device.

2. The patch of claim 1, wherein said battery has sufficient capacity to power the electrical components of said patch continuously for at least 30 days.

3. The patch of claim 1 further comprising a manually operable switch to mark a cardiac event experienced by the patient when wearing said patch.

4. The patch of claim 1 further comprising an indicator for producing an alert to one of the patient'"'"'s senses in response to a cardiac event detected by said processor.

5. The patch of claim 1, wherein said patch is relatively flexible to adapt to the contour of the patient'"'"'s body at said secured location, and relatively flat with a maximum thickness less than about 3 mm.

6. The patch of claim 1 wherein said signal processor is adapted to detect a cardiac event including arrhythmia, syncope, block, palpitation, transient ischemic attack, myocardial infarction and fibrillation.

7. The patch of claim 1, further comprising a flexible electrical circuit for interconnecting electrical components within said patch to perform their respective functions.

8. The patch of claim 1, wherein said processor is adapted to perform at least one of signal averaging and segment analysis.

9. The patch of claim 1, wherein said patch comprises multiple electrodes sufficient to enable said processor to perform diagnostic analysis.

10. The patch of claim 1, wherein said waterproofing comprise a waterproof adhesive on the perimeter of an inside surface of the patch.

11. The patch of claim 1, further comprising an anti-microbial agent on said patch to prevent contamination thereof during extended wear of said patch.

12. The patch of claim 1, further comprising air permeable material to allow air access to the skin and prevent accumulation of moisture thereon.

13. The patch of claim 1, wherein said transmitter includes means for transmitting ECG of cardiac events via telephone.

14. A patch for non-invasive monitoring of ECG signals, comprising:

means for self adhering said patch to the chest of a person being evaluated for a heart abnormality;

at least two electrodes for contacting said person'"'"'s skin surface, said electrodes receiving the surface potential ECG signals;

an amplifier for amplifying said ECG signals from said electrodes;

a processor for performing analysis of said amplified ECG signals and producing a preformatted report;

a battery for powering said patch; and

means for wireless transmission of said preformatted report to a reporting device.

15. The patch of claim 14, wherein said reporting device is any of a printer and a wireless network.

16. The patch of claim 14, wherein said wireless transmission comprises any of infrared (IR) signals and radio frequency (RF) signals.

17. The patch of claim 14 further comprising an indicator to alert the person to a cardiac event detected by said processor.

18. The patch of claim 14 further comprising a switch to mark a cardiac event experienced by said person wearing said patch.

19. The patch of claim 14, wherein said patch comprises multi-lead electrodes for performing diagnostic analysis.

20. The patch of claim 14, wherein said patch is “

C”

shaped encompassing the person'"'"'s left breast.

21. The patch of claim 14, wherein said patch is waterproof to allow continuous long-term wear and operation including during water exposure.

22. The patch of claim 14 further comprising means for transmitting ECG of cardiac events via the telephone.

23. A disposable patch for non-invasive monitoring of ECG comprising:

means for self adhering said patch to a person'"'"'s torso, said person is being evaluated for a heart abnormality;

at least two electrodes for contacting said person'"'"'s skin surface, said electrodes receiving the surface potential ECG signals;

an amplifier for amplifying said ECG signals from said electrodes;

a processor for detecting a cardiac event;

a battery for powering said patch;

an indicator for indicating the occurrence of a cardiac event detected by said processor; and

means for waterproofing said patch whereby it can be worn continuously for at least 14 days including during bathing.