Non-invasive device for diagnosing gastroesophageal reflux

• US 8,568,336 B2
• Filed: 08/18/2009
• Issued: 10/29/2013
• Est. Priority Date: 08/18/2008
• Status: Active Grant

• Current Assignee: The Board of Trustees of Michigan State University (Michigan State University)
• Original Assignee: The Board of Trustees of Michigan State University (Michigan State University)
• Inventors: Gewolb, Ira H., Vice, Frank L.
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US13/003,986
• Publication Number:
  US 20110313320A1
• Time in Patent Office: 1,533 Days
• Field of Search: 600/300, 600/301, 600/586, 600/593
• US Class Current: 600/586
• CPC Class Codes: A61B 2562/0204 Acoustic sensors
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/4211 Diagnosing or evaluating reflux
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/7257 using Fourier transforms
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: A61B 7/008 Detecting noise of gastric tract, e.g. caused by voiding

Abstract

The present invention provides compositions and methods useful in the diagnosis and management of Gastroesophageal Reflux. Specifically, the inventions provide a device and methods of using the device for accurately, quantitatively, and non-invasively diagnosing Gastroesophageal reflux disease (GERD) in both patients at risk for GERD and patients demonstrating reflux-like symptoms. In particular, the inventions relate to detecting and analyzing upward esophageal movements in patients, such as human infants, children, and adults.

Claims

1. A method, comprising,

a) providing,

ii) a subject at risk of having an esophageal reflux movement;

ii) a system comprising a low frequency sensor in electronic communication with an analog-to-digital signal converter device, wherein said sensor is capable of capturing a sub-audible signal; and

b) attaching the sensor externally to said subject, and

c) capturing a sub-audible signal with said sensor of said esophageal reflux movement of said subject, and

d) communicating said signal to said analog-to-digital signal converter device.

2. The method of claim 1, further providing a computer processor capable of analyzing a digital signal from the analog-to-digital signal converter device and comprising:

step e) analyzing and graphically viewing said sub-audible signal.

3. The method of claim 2, where the system further comprises software capable of transforming said digital signal by a conversion algorithm selected from the group consisting of a fast Fourier Transform (FFT) and Continuous Wavelet Transform (CWT), wherein said software is in operable combination with a computer processor.

4. The system of claim 1, further comprising software capable of capturing a variable selected from the group consisting of frequency, range, amplitude, and duration in time, wherein said software is in operable combination with a computer processor.

5. The system of claim 1, wherein the system further comprises software capable of visually displaying a signal in a graphical output comprising amplitude, time, and frequency, wherein said software is in operable combination with a computer processor.

6. The method of claim 1, wherein the system further comprises software capable of distinguishing a reflux event from a non-reflux event, wherein said method further comprises using said software for distinguishing a reflux event from a non-reflux associated event.

7. The method of claim 1, wherein the sub-audible signal ranges between 1 and 40 Hertz.

8. The method of claim 1, wherein the sub-audible signal is originating from the subject'"'"'s lower esophageal sphincter.

9. The method of claim 1, wherein said sensor comprises a plurality of sensors.

10. The method of claim 1, wherein said sensor is an accelerometer.

11. The method of claim 1, wherein said system does not include an analog recording device.

12. The method of claim 1, wherein said subject is selected from the group comprising a pre-term infant, an infant, a child, a teenager, and an adult.

13. The method of claim 1, wherein said subject is at risk for a gastroesophageal reflux disease.

14. The method of claim 1, wherein said capturing a sub-audible signal is selected from the group consisting capturing of a signal of an acidic condition of said subject and capturing a signal of a non-acidic condition of said subject.

15. The method of claim 1, wherein said sensor is attached on said subject'"'"'s body exterior in locations selected from the group consisting of the anterior thoracic cage between the sub-xiphoid process and the thoracic inlet and the posterior thorax over the esophageal area.