# US 10,478,116 B2 · Methods and systems for feeding readiness diagnosis

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- Number: US 10,478,116 B2
- Document ID: US10478116B2
- Status: Granted
- Kind: B2
- Application number: 15/114,957
- Filed: 2015-01-30
- Published: 2016-11-24
- Granted: 2019-11-19
- Earliest claimed: 2014-01-30
- Assignees: University of Florida Research Foundation, Inc.
- Applicants: University of Florida Research Foundation, Inc.
- Inventors: Josef Neu; Sungho Oh; Jui-Hong Chien; Eric Ortigoza
- Web page: https://patentgrep.com/patent/US10478116B2

## CPC

- A61B 5/4238: {stomach}
- A61B 5/0075: {by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy (A61B5/0071 takes precedence)}
- A61B 5/14542: {for measuring blood gases (A61B5/14551 takes precedence)}
- A61B 5/24: Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B 5/392: Detecting gastrointestinal contractions
- 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 5/684: {Indicating the position of the sensor on the body}
- A61B 5/7207: {of noise induced by motion artifacts}
- A61B 5/7221: {Determining signal validity, reliability or quality (preventing, reducing or removing noise induced by motion artefacts A61B5/7207; noise originating from a therapeutic or surgical apparatus A61B5/7217)}
- A61B 5/7264: {Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems}
- A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor}
- A61B 5/7282: {Event detection, e.g. detecting unique waveforms indicative of a medical condition (cough events A61B5/0823; seizures A61B5/4094; sleep apnoea A61B5/4818)}
- A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)}
- A61B 7/008: {Detecting noise of gastric tract, e.g. caused by voiding}
- A61B 2503/045: Newborns, e.g. premature baby monitoring
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An aspect of the invention described herein includes a method for a digestion diagnosis of a subject. The method includes obtaining electrogastrogram (EGG), bowel sound and NIRS signals from one or more sensors positioned about an abdominal region of a subject, removing artifacts from the signals to obtain conditioned signal data, and determining a digestion condition or feeding readiness of the subject based at least in part on the conditioned signal data.

## Claims

### Claim 1

A method for diagnosing a digestion condition of a subject, the method comprising:
obtaining electrogastrogram (EGG), bowel sound, and Near Infrared Spectroscopy (NIRS) signals from an EGG sensor, acoustic sensor and NIRS sensor, respectively, positioned about an abdominal region of a subject;
removing artifacts from the signals to obtain conditioned signal data; and
determining a digestion condition of the subject based at least in part upon the conditioned signal data, wherein determining the digestion condition of the subject comprises identifying an abnormal digestion condition or the location or severity thereof.

### Claim 2 (depends on 1)

The method of claim 1, further comprising determining gastrointestinal (GI) signal features from the conditioned GI signal data, wherein the digestion condition is based at least in part upon the GI signal features.

### Claim 3 (depends on 1)

The method of claim 1, wherein the artifacts comprise movement artifacts, recording environment-related artifacts and sensor-related artifacts, or a combination thereof.

### Claim 4 (depends on 1)

The method of claim 1, wherein the subject is a preterm infant.

### Claim 5 (depends on 4)

The method of claim 4, wherein the infant is less than 34 weeks gestational, or less than 29 weeks gestational.

### Claim 6 (depends on 1)

The method of claim 1, wherein the abnormal digestion condition is a post-prandial decrease of A-rSO2.

### Claim 7 (depends on 1)

The method of claim 1, wherein the abnormal digestion condition is post-prandial decrease in EGG and/or AC signal levels.

### Claim 8 (depends on 1)

The method of claim 1, further comprising:
determining with a processor a recording condition for each of the one or more sensors based upon predefined sensor criteria;
wherein when an acceptable recording condition is identified, one or more signals are obtained from the one or more sensors, and wherein when an unacceptable recording condition is identified, an indication of the sensor corresponding to the unacceptable recording condition is provided.

### Claim 9 (depends on 8)

The method of claim 8, wherein following an indication of the sensor corresponding to the unacceptable recording condition, a communication to a user for correction of the unacceptable recording condition is provided.

### Claim 10 (depends on 8)

The method of claim 8, further comprising amplification and filtering of the one or more obtained GI signals.

### Claim 11 (depends on 8)

The method of claim 8, further comprising sampling the one or more obtained GI signals to obtain digital GI data.

### Claim 12

A system for diagnosis of a digestion condition or feeding readiness of a subject, or a combination thereof, the system comprising:
a signal recording module configured to acquire GI signals from one or more sensors positioned about an abdominal region of a subject, wherein the GI signals comprise electrogastrogram (EGG), bowel sound, and Near Infrared Spectroscopy (NIRS) signals from an EGG sensor, acoustic sensor and NIRS sensor, respectively;
a signal conditioning module configured to condition GI signal data from the one or more GI signals, wherein the signal conditioning module is configured to remove artifacts associated with movement of the subject from the GI signal data;
a signal analysis module configured to determine at least one feature of a GI signal based at least in part on the conditioned GI signal data; and
a condition classification module configured to determine a digestion condition of the subject based at least in part on the at least one feature of the GI signal; wherein the signal conditioning module is configured to remove artifacts associated with movement of the subject from the GI signal data and the condition classification module is configured to identify a location and/or a severity of an abnormal digestion condition.

### Claim 13 (depends on 12)

The system of claim 12, further comprising a sensor application module configured to verify a recording condition of the one or more sensors based upon predefined sensor criteria.

### Claim 14 (depends on 2)

The system of claim 2, wherein the signal conditioning module is configured to remove artifacts associated with movement of the subject from the GI signal data.

### Claim 15 (depends on 12)

The system of claim 12, wherein the at least one feature of the GI signal comprises a cerebrosplanchnic oxygen ratio value or a splanchnic circulation value, to determine if a subject is at risk for disease.

### Claim 16 (depends on 12)

The system of claim 12, wherein a cerebrosplanchnic oxygen ratio is recorded by the signal recording module, and wherein the condition classification module determines a digestion condition of the subject based on the cerebrosplanchnic oxygen ratio.

### Claim 17 (depends on 16)

The system of claim 16, wherein the digestion condition of the subject comprises an ability of the subject to tolerate an orogastric feed.

### Claim 18

A system for diagnosis of a digestion condition and/or a feeding readiness of a subject and to identify a subject at risk for disease, comprising:
a computer comprising a computer processing module or modules to process (i) an EGG signal input; (ii) a bowel sound input and (iii) a NIRS input;
a display to present data to an operator of the system; and
an EGG probe, a bowel sound stethoscope and an NIRS probe in communication with said computer; and determining with the computer a digestion condition of the subject based at least in part upon the EGG, bowel sound and NIRS input data, wherein determining the digestion condition of the subject comprises identifying an abnormal digestion condition or the location or severity thereof.

### Claim 19 (depends on 18)

The system of claim 18, further comprising a signal conditioning module configured to condition one or more of (i), (ii) or (iii) inputs.
