# US 10,499,829 B2 · Wearable wireless patches containing electrode pair arrays for gastrointestinal electrodiagnostics

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- Number: US 10,499,829 B2
- Document ID: US10499829B2
- Status: Granted
- Kind: B2
- Application number: 15/919,578
- Filed: 2018-03-13
- Published: 2018-07-19
- Granted: 2019-12-10
- Earliest claimed: 2012-10-10
- Assignees: G-Tech Medical, Inc.
- Applicants: G-Tech Medical, Inc.
- Inventors: Steve Axelrod; Anand Navalgund; Eric A. Hoffman
- Web page: https://patentgrep.com/patent/US10499829B2

## CPC

- A61B 5/392: Detecting gastrointestinal contractions
- A61B 5/0006: {ECG or EEG signals}
- A61B 5/0024: {for multiple sensor units attached to the patient, e.g. using a body or personal area network}
- A61B 5/08: Measuring devices for evaluating the respiratory organs
- A61B 5/1107: {Measuring contraction of parts of the body, e.g. organ or muscle}
- A61B 5/1123: {Discriminating type of movement, e.g. walking or running (A61B5/1116, A61B5/112 take precedence)}
- A61B 5/296: for electromyography [EMG]
- A61B 5/374: Detecting the frequency distribution of signals, e.g. detecting delta, theta, alpha, beta or gamma waves
- A61B 5/42: {Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems (A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence)}
- A61B 5/4205: {Evaluating swallowing}
- A61B 5/4211: {Diagnosing or evaluating reflux}
- A61B 5/6823: {Trunk, e.g., chest, back, abdomen, hip}
- A61B 5/6831: {Straps, bands or harnesses}
- A61B 5/6833: {Adhesive patches}
- A61B 5/7203: {for noise prevention, reduction or removal}
- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G16H 40/63: for local operation
- G16H 40/67: for remote operation
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients
- A61B 5/11: Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb {(A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721)}
- A61B 2562/0209: Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
- A61B 2562/04: Arrangements of multiple sensors of the same type
- A61B 2562/164: the sensor is mounted in or on a conformable substrate or carrier
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## 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

### Claim 1

A wearable, non-invasive wireless electrodiagnostic system for profiling gastrointestinal tract activity of an ambulatory patient,
the system comprising:
an electromyographic-sensing patch adapted for multi-day constant attachment to a skin surface of a midsection of a patient, the patch comprising:
an array of bipolar electrode pairs comprising two or more bipolar electrode pairs, wherein each individual electrode of the bipolar electrode pairs comprises an electrode-specific identifier, and a ground electrode is disposed centrally within a circumferential arrangement of a plurality of active electrodes,
wherein information in the patch is integrated and dynamically combined such that the pairing between each of the electrodes that form each bipolar pair and the corresponding data obtained from the array of bipolar electrode pairs are combined based on incoming data optimization algorithms, and
wherein the incoming data optimization algorithms comprise one or more of: time series analysis, time-dependent frequency analysis, and pattern matching analysis of spatio-temporal electromyographic data derived from the array of bipolar electrode pairs; and
a circuit board having a battery and a processor with instructions stored in memory,
wherein implementation of the instructions causes the processor to identify individual electrodes via the electrode-specific identifier, receive signals from the array of bipolar electrode pairs over a period of at least one day, amplify and digitize the electromyographic data from the signals, and transmit data to at least one of a remote computing device or a networked computing device.

### Claim 2 (depends on 1)

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.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 1)

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.

### Claim 5 (depends on 1)

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, and video.

### Claim 6 (depends on 1)

The wearable, non-invasive wireless electrodiagnostic system of claim 1, further comprising the remote computing device, 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 patient.

### Claim 7 (depends on 1)

The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the patch comprises one or more patches and the system further comprises the remote computing device, wherein communication between the one or more patches and the remote computing device occurs wirelessly using one or more of Bluetooth, Wi-Fi, cellular, and infrared.

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

The wearable, non-invasive wireless electrodiagnostic system of claim 1, further comprising the remote computing device, 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.

### Claim 10 (depends on 1)

The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the instructions stored in memory cause the processor to receive the signals intermittently from the array over the period.

### Claim 11 (depends on 1)

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

### Claim 12 (depends on 1)

The wearable, non-invasive wireless electrodiagnostic system of claim 1, wherein the system comprises a plurality of greater than one patch positioned on the patient.

### Claim 13 (depends on 1)

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

### Claim 14 (depends on 1)

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.

### Claim 15 (depends on 1)

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

### Claim 16 (depends on 1)

The wearable, non-invasive wireless electrodiagnostic system of claim 1, further comprising the remote computing device, 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 a body of the patient, 3-dimensional co-ordinate mapping of the signal on the body of the patient, co-ordination of signal with position of the gastrointestinal tract of the patient, and combinations thereof.