Array sonography for esophageal characterization

• US 10,617,387 B2
• Filed: 08/29/2017
• Issued: 04/14/2020
• Est. Priority Date: 09/01/2016
• Status: Active Grant

• Current Assignee: Reflodx, LLC
• Original Assignee: Reflodx, LLC
• Inventors: Wilcox, Andrew, Thomas, Samuel, Jones, Joshua, Pickett, Timothy
• Primary Examiner(s): Bui Pho, Pascal M
• Assistant Examiner(s): Bykhovski, Alexei
• Application Number:
  US15/689,874
• Publication Number:
  US 20180055482A1
• Time in Patent Office: 959 Days
• CPC Class Codes: A61B 8/08 Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence
• CPC Class Codes: A61B 8/145 characterised by scanning multiple planes
• CPC Class Codes: A61B 8/15 Transmission-tomography
• CPC Class Codes: A61B 8/4236 characterised by adhesive patches
• CPC Class Codes: A61B 8/4427 Device being portable or laptop-like
• CPC Class Codes: A61B 8/4477 using several separate ultrasound transducers or probes
• CPC Class Codes: A61B 8/5223 for extracting a diagnostic or physiological parameter from medical diagnostic data for algorithms to analyse biomedical images G06T7/0012
• CPC Class Codes: A61B 8/56 Details of data transmission or power supply
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

The present invention relates to devices for detecting esophageal state changes. More specifically, the present invention relates to a lightweight, portable, user-operable device capable of detecting gastroesophageal reflux events. The sonography array can also be used to track the frequency of gastroesophageal reflux events, and can either store or deliver the data either to a practitioner'"'"'s server or to a user'"'"'s electronic device.

Claims

1. A system for monitoring and characterizing an esophageal state of a user'"'"'s esophagus comprising:

an ambulatory data collection box comprising a microprocessor and one or more auxiliary sensors, the one or more auxiliary sensors comprising at least one of a microphone, an accelerometer, a gyroscope, and a positional sensor;

a sensor pad to be placed on the skin of the user near the user'"'"'s esophagus, the sensor pad in communication with the microprocessor, the sensor pad comprising a first ultrasonic transducer, wherein the first ultrasonic transducer is to be attached to skin of the user in a first transverse plane of the user'"'"'s esophagus;

at least one processor programmed to generate a plurality of acoustic frames representative of an amplitude and a time of flight;

the at least one processor programmed to analyze the plurality of acoustic frames to determine an acoustic frame representative of a baseline esophageal state and measure a first distance between an outer and an inner wall of the user'"'"'s esophagus;

the at least one processor programmed to analyze at least a second acoustic frame and measure a second distance between the outer and the inner wall of the user'"'"'s esophagus; and

the at least one processor programmed to compare the first distance to the second distance and assign an expanded esophageal state when the second distance is smaller than the first distance.

2. The system of claim 1, further comprising a second ultrasonic transducer, the first ultrasonic transducer and the second ultrasonic transducer having a sampling frequency, the ambulatory data collection box being adapted to alter the sampling frequency of the first ultrasonic transducer and second ultrasonic transducer simultaneously.

3. The system of claim 1, further comprising a second ultrasonic transducer, the first ultrasonic transducer and the second ultrasonic transducer, each having a sampling frequency, the ambulatory data collection box being adapted to alter the sampling frequency of the first ultrasonic transducer independently of the second ultrasonic transducer.

4. The system of claim 1, wherein the ambulatory data collection box further comprises a battery, a power and a ground sensor, a voltage regulator, and a digital processor.

5. The system of claim 1, further comprising a software interface, the software interface comprising a granularity selection.

6. The system of claim 1, wherein the microprocessor is further programmed to identifying at least one point of interest in each of the acoustic frames, and analyze the at least one point of interest in each of the acoustic frames to determine acoustic frames representative of the baseline esophageal state and acoustic frames representative of a change in the baseline esophageal state.

7. The system of claim 6, wherein the one or more auxiliary sensors are configured to record an extra-esophageal event, and wherein the microprocessor is programmed to assign a time to the extra-esophageal event which is not representative of a bolus.

8. The system of claim 1, wherein the microprocessor is further programmed to assign a baseline esophageal state when the second distance equal to the first distance.

9. The system of claim 1, wherein the microprocessor comprises the at least one processor.

10. A system for characterizing esophageal events, the system comprising:

a wearable acquisition device comprising a microprocessor; and

at least one ultrasonic transducer, the at least one ultrasonic transducer configured to be placed proximal to a first transverse plane of an esophagus;

at least one processor programmed to receive acoustic data from the at least one ultrasonic transducer representative of a time of flight and an amplitude;

the at least one processor programmed to assign a first distance between outer walls of the esophagus based on the acoustic data;

the at least one processor programmed to assign a second distance between the outer walls of the esophagus based on the acoustic data; and

the at least one processor programmed to compare the first distance to the second distance and the processor further programmed to assign an expanded esophageal state when the second distance is greater than the first distance.

11. The system according to claim 10, wherein the wearable acquisition device further comprises one or more auxiliary sensors.

12. The system according to claim 11, wherein the one or more auxiliary sensors comprise at least one of a microphone, an accelerometer, a gyroscope, and a positional sensor.

13. The system of claim 12, wherein the at least one processor is programmed to generate an acoustic frame representative of the acoustic data and identify at least one point of interest in the acoustic frame.

14. The system of claim 13, wherein the at least one processor is further programmed to identify and analyze a plurality of points of interest on a plurality of acoustic frames.

15. The system of claim 14, wherein the at least one processor is further programmed to analyze multiple acoustic frames to determine acoustic frames representative of a baseline esophagus state and a change in the baseline esophagus state.

16. The system of claim 10, wherein the microprocessor comprises the at least one processor.

17. A method of detecting and characterizing an esophageal state of an esophagus of a user, the method comprising:

attaching a first ultrasonic transducer to a skin of the user proximal to the esophagus;

generating, by the first ultrasonic transducer, a frequency;

sensing, by the first ultrasonic transducer, acoustic signals representative of a plurality of amplitudes and times of flight for a first time period and a second time period;

generating, by a processor, a first acoustic frame representative of the plurality of amplitudes and the times of flight for the first time period, and a second acoustic frame representative of the plurality of amplitudes and the times of flight for the second time period;

determining a first maximum amplitude in the first acoustic frame;

determining a second maximum amplitude in the second acoustic frame; and

assigning an expanded state of the esophagus when the second maximum amplitude is greater than the first maximum amplitude.

18. The method according to claim 17, further comprising the step of providing an ancillary sensor to record an esophageal event not representative of a bolus, and assigning a time to the esophageal event which is not a bolus.