Wearable wireless patches containing electrode pair arrays for gastrointestinal electrodiagnostics

• US 9,943,264 B2
• Filed: 10/10/2013
• Issued: 04/17/2018
• Est. Priority Date: 10/10/2012
• Status: Active Grant

• Current Assignee: GTECH Corporation (GTECH SpA)
• Original Assignee: G-Tech Medical Inc.
• Inventors: Axelrod, Steve, Navalgund, Anand, Hoffman, Eric A., Devanaboyina, Uday Sankar
• Primary Examiner(s): CERIONI, DANIEL LEE
• Application Number:
  US14/051,440
• Publication Number:
  US 20160045137A1
• Time in Patent Office: 1,650 Days
• Field of Search: 600546
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/392 Detecting gastrointestinal contractions
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip

Abstract

A system and method for profiling electrical activity in smooth muscle of the gastrointestinal tract muscular of a patient are disclosed. The system includes electromyographic-sensing patches adapted for placement on the skin of the abdomen of the patient. Each patch has at least one bipolar electrode pair, or a multitude arranged in an array, and is enabled for communication of a signal indicative of a sensed electromyographic signal. The system further includes networked computing devices. The local patch device is configured for wireless communication between the EMG-sensing patches and a local computing device, to enable wireless transmission from the patch to the networked computing devices. The networked computing device is configured to process large aggregate collections of multi-hour or day signals received from the local computing device to yield diagnostically valuable physiological parameters of gastrointestinal smooth muscle electrical activity.

Claims

1. A wearable, non-invasive wireless electrodiagnostic system for profiling gastrointestinal tract muscular activity of a subject, the system comprising:

an electromyographic-sensing patch adapted for multi-day constant attachment to a skin surface of a midsection of a subject, the patch comprising;

a particularly arranged array comprising a plurality of active bipolar electrode pairs arranged circumferentially around a ground electrode, and

a circuit board having a battery and a local electronic device with instructions stored in memory, wherein implementation of the instructions causes the local electronic device to receive signals from the array of bipolar electrode pairs over a period of at least one day, amplify and digitize myoelectric data from the signals, and transmit data to a remote computing device.

2. The wearable, non-invasive wireless electrodiagnostic system of claim 1, where the array enables a maximum number of electrode pairs to be arranged substantially orthogonally to each other in order to better sense signals originating from any orientation or location.

3. The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the patch comprises a memory capacity sufficient to store accumulated signal for a period of up to at least one hour.

4. The wearable, non-invasive wireless electrodiagnostic system of claim 1, further comprising one or more sensors selected from the group consisting of:

an accelerometer, motion sensor, position sensor, heart rate sensor, blood pressure meter, respiration rate sensor, sensor to detect blood oxygen levels, body temperature sensor, galvanic skin response sensor, skin-electrode impedance sensor, electrode-electrode impedance sensor, electrocardiogram sensor, electroencephalogram sensor, audio microphone, camera, or video.

5. The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the remote computing device is further configured to mathematically and algorithmically process and analyze aggregated amounts of spatiotemporal electromyographic signals to yield visually displayable, diagnostically-valuable physiological parameters of gastrointestinal smooth muscle electrical activity of the subject.

6. The wearable, non-invasive wireless electrodiagnostic system of claim 5, wherein an analysis performed by the remote computing device is selected from the group consisting of:

time series analysis, time-dependent frequency analysis, and pattern matching analysis.

7. The wearable, non-invasive wireless electrodiagnostic patch system of claim 1, wherein the remote computing device is further configured to receive user inputs from a patient providing information regarding meal contents, bowel movements, physical activity, or abdominal pain and synchronize and combine the information with time-stamped myoelectric data.

8. The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the remote computing device is further configured to execute time and frequency based algorithms to extract events and patterns of events related to activity of gastrointestinal organs.

9. The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the instructions stored by the local electronic device cause the local electronic device to receive the signals intermittently from the array over the period.

10. The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the patch is configured to sense myoelectric signals originating in the smooth muscles of a stomach, a small intestine, and a colon.

11. The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the system comprises a plurality of patches positioned on a patient.

12. The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the patch is water-resistant and the circuit board is waterproof.

13. The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the patch includes a pressure-sensitive adhesive configured to adhere to the skin surface for more than one day.

14. The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the battery is configured to sustain operation of continuous monitoring for a period of at least 24 hours.

15. The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the array of bipolar electrode pairs comprises eight active bipolar electrodes forming four bipolar pairs.

16. The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the array of bipolar electrode pairs comprises two parallel pairs of bipolar electrodes and an orthogonal pair of bipolar electrodes.

17. The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the remote computing device comprises a data analysis application configured to isolate a desired signal from the transmitted data, the analysis application selected from the group consisting of:

individuation of processed data according to unique identifiers, isolation based on subtraction of patterns ascribable to sources other than gastrointestinal smooth muscle, isolation based on weighing relative signal strength ascribable to sources other than gastrointestinal smooth muscle, detection of signal peaks at same or different frequencies, fast Fourier transformation to optimize signal to noise ratio and signal strength, wavelet transform analysis, pattern analysis, search for non-sinusoidal patterns, 2-dimensional co-ordinate mapping of the signal on the patient'"'"'s body, 3-dimensional co-ordinate mapping of the signal on the patient'"'"'s body, co-ordination of signal with position of the gastrointestinal tract of the patient, and combinations thereof.