Meal detection devices and methods

• US 9,168,000 B2
• Filed: 03/13/2013
• Issued: 10/27/2015
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Dunki-Jacobs, Adam, Harris, Jason L., Lemay, Mathieu, Pfleiderer, Martin, Proena, Martin, Utard, Thierry
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US13/802,089
• Publication Number:
  US 20140275748A1
• Time in Patent Office: 958 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/392 Detecting gastrointestinal contractions
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 7/008 Detecting noise of gastric tract, e.g. caused by voiding
• CPC Class Codes: A61F 2005/002 for sensing mechanical parameters
• CPC Class Codes: A61F 5/0013 Implantable devices or invasive measures
• CPC Class Codes: A61F 5/0059 with wireless means
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Devices and methods for detecting meal intake are disclosed herein. In some embodiments, one or more sensors can be used to detect or monitor physiological parameters of a user (e.g., heart rate, body movements, temperature, pH, impedance, gastric stretch, sound emissions, and the like). The outputs of the sensors can be received by a computer system configured to analyze the sensor data and make a determination as to whether meal intake has occurred or is presently occurring. The computer system'"'"'s determination can be used to trigger, modulate, or otherwise control one or more therapeutic devices. Other types of devices can also be controlled using this determination, such as monitoring or logging devices.

Claims

1. A meal detection system, comprising:

a plurality of sensors, each configured to sense a different physiological parameter of a user, the plurality of sensors being disposed external to the user;

a processor in communication with the plurality of sensors and configured to analyze outputs of the plurality of sensors to detect meal intake by the user, the processor being further configured to trigger a controlled device to deliver a therapy to the user in response to meal intake detected by the processor;

wherein, for each of the plurality of sensors, the processor is configured to calculate an index based on the output of the sensor and to determine that meal intake occurred when the index exceeds a threshold value; and

wherein the processor is configured to calculate the threshold value by processing a set of training data usin an average harmonic mean algorithm, the training data including sensor data for at least one user and ground truth data for the at least one user.

2. The system of claim 1, wherein the plurality of sensors are of different types.

3. The system of claim 1, wherein the plurality of sensors includes an electromyograph configured to detect electrical activity of a muscle of the user and wherein the processor is configured to calculate an electromyograph index based on a number of peaks detected in the electromyograph output.

5. The system of claim 1, wherein the plurality of sensors includes an electrocardiograph configured to detect electrical activity of a heart of the user and wherein the processor is configured to calculate an electrocardiograph index based on a moving average filtered first derivative of the standard deviation of interbeat intervals in the electrocardiograph output.

6. The system of claim 1, wherein the plurality of sensors includes a temperature sensor configured to detect a temperature of the user and wherein the processor is configured to calculate a temperature sensor index based on a ratio of low frequency components of the first derivative of the temperature sensor output to low frequency components of the standard deviation of the temperature sensor output.

8. The system of claim 1, wherein the plurality of sensors includes an electrogastrograph configured to detect electrical activity of a digestive system of the user and wherein the processor is configured to calculate an electrogastrograph index based on the total energy of the electrogastrograph output in a frequency band of interest.

9. The system of claim 1, wherein the plurality of sensors includes an impedance sensor configured to detect an impedance across a portion of the user and wherein the processor is configured to calculate an impedance sensor index based on the median energy of the impedance sensor output in a frequency band of interest.

10. The system of claim 1, further comprising a controlled device, the controlled device being configured to at least one of:

electrically stimulate tissue of the user;

deliver a therapeutic agent to the user;

deliver a therapeutic agent configured to provoke a release of one or more hormones from L-cells of the user to trigger ileal brake in the user;

deliver insulin to the user;

modulate bile acid levels in the user;

modulate gastric pH levels in the user;

induce an aversive response in the user;

stimulate release of GLP-1 in the user;

activate brown adipose tissue in the user;

adjust a gastric band implanted in the user;

control tonal contractions of the user'"'"'s stomach;

adjust a size or volume of a gastric space occupying device implanted in the user;

modulate gastric emptying in the user;

record a history of the user'"'"'s meal intake events; and

issue an alert to the user or to a caregiver of the user when the user'"'"'s meal intake exceeds a predetermined threshold or deviates from a predetermined pattern.

4. The system of 1, wherein the plurality of sensors includes a microphone configured to detect sounds emitted by the user and wherein the processor is configured to calculate a microphone index based on frequency matching and temporal matching of the microphone output to a predetermined pattern.

7. The system of 1, wherein the plurality of sensors includes an accelerometer configured to detect motion of the user and wherein the processor is configured to calculate an accelerometer index based on the total energy of the accelerometer output in a frequency band of interest.

11. A meal detection system, comprising:

a plurality of sensors, each configured to sense a different physiological parameter of a user, the plurality of sensors being disposed external to the user; and

a processor in communication with the plurality of sensors and configured to analyze outputs of the plurality of sensors to detect meal intake by the user, the processor being further configured to trigger a controlled device to deliver a therapy to the user in response to meal intake detected by the processor,

wherein the plurality of sensors includes an electromyograph and an accelerometer, and wherein the processor is configured to calculate an electromyograph index, an electromyograph threshold value, an accelerometer index, and an accelerometer threshold value, and to determine that;

solid meal intake occurred when the electromyograph index exceeds the electromyograph threshold value;

liquid meal intake occurred when the electromyograph index does not exceed the electromyograph threshold value and the accelerometer index exceeds the accelerometer threshold value; and

no meal intake occurred when the electromyograph index does not exceed the electromyograph threshold value and the accelerometer index does not exceed the accelerometer threshold value.

12. A meal detection system, comprising:

a plurality of sensors, each configured to sense a different physiological parameter of a user, the plurality of sensors being disposed external to the user; and

a processor in communication with the plurality of sensors and configured to analyze outputs of the plurality of sensors to detect meal intake by the user, the processor being further configured to trigger a controlled device to deliver a therapy to the user in response to meal intake detected by the processor,

wherein the plurality of sensors includes an impedance sensor and an accelerometer, and wherein the processor is configured to calculate an impedance sensor index, an impedance sensor threshold value, an accelerometer index, and an accelerometer threshold value, and to determine that;

solid meal intake occurred when the impedance sensor index exceeds the impedance sensor threshold value;

liquid meal intake occurred when the impedance sensor index does not exceed the impedance sensor threshold value and the accelerometer index exceeds the accelerometer threshold value; and

no meal intake occurred when the impedance sensor index does not exceed the impedance sensor threshold value and the accelerometer index does not exceed the accelerometer threshold value.

13. A meal detection system, comprising:

a plurality of sensors, each configured to sense a different physiological parameter of a user, the plurality of sensors being disposed external to the user; and

a processor in communication with the plurality of sensors and configured to analyze outputs of the plurality of sensors to detect meal intake by the user, the processor being further configured to trigger a controlled device to deliver a therapy to the user in response to meal intake detected by the processor,

wherein the plurality of sensors includes an electromyograph and a microphone, and wherein the processor is configured to calculate an electromyograph index, an electromyograph threshold value, a microphone index, and a microphone threshold value, and to determine that;

solid meal intake occurred when the electromyograph index exceeds the electromyograph threshold value;

liquid meal intake occurred when the electromyograph index does not exceed the electromyograph threshold value and the microphone index exceeds the microphone threshold value; and

no meal intake occurred when the electromyograph index does not exceed the electromyograph threshold value and the microphone index does not exceed the microphone threshold value.

14. A meal detection system, comprising:

a plurality of sensors, each configured to sense a different physiological parameter of a user, the plurality of sensors being disposed external to the user; and

a processor in communication with the plurality of sensors and configured to analyze outputs of the plurality of sensors to detect meal intake by the user, the processor being further configured to trigger a controlled device to deliver a therapy to the user in response to meal intake detected by the processor,

wherein the plurality of sensors includes an impedance sensor and a microphone, and wherein the processor is configured to calculate an impedance sensor index, an impedance sensor threshold value, a microphone index, and a microphone threshold value, and to determine that;

solid meal intake occurred when the impedance sensor index exceeds the impedance sensor threshold value and the microphone index exceeds the microphone threshold value;

liquid meal intake occurred when the impedance sensor index does not exceed the impedance sensor threshold value and the microphone index exceeds the microphone threshold value; and

no meal intake occurred when the impedance sensor index does not exceed the impedance sensor threshold value and the microphone index does not exceed the microphone threshold value.

15. A medical method, comprising:

sensing a plurality of physiological parameters of a user using a plurality of sensors disposed externally to the user;

using a processor in communication with the plurality of sensors, analyzing outputs of the plurality of sensors to detect meal intake by the user; and

automatically triggering a controlled device to deliver a therapy to the user in response to meal intake detected by the processor;

for each of the plurality of sensors, using the processor o calculate an index based on the output of the sensor and using the processor to determine that meal intake occurred when the index exceeds a threshold value; and

using the processor to calculate the threshold value by processing a set of training data using an average harmonic mean algorithm, the training data including sensor data for at least one user and ground truth data for the at least one user.

16. The method of claim 15, wherein said sensing and said analyzing include at least one of:

detecting electrical activity of a muscle of the user using an electromyograph and calculating an electromyograph index based on a number of peaks detected in the electromyograph output;

detecting sounds emitted by the user using a microphone and calculating a microphone index based on frequency matching and temporal matching of the microphone output to a predetermined pattern;

detecting electrical activity of a heart of the user using an electrocardiograph and calculating an electrocardiograph index based on a moving average filtered first derivative of the standard deviation of interbeat intervals in the electrocardiograph output;

detecting a temperature of the user and calculating a temperature sensor index based on a ratio of low frequency components of the first derivative of the temperature sensor output to low frequency components of the standard deviation of the temperature sensor output;

detecting motion of the user using an accelerometer and calculating an accelerometer index based on the total energy of the accelerometer output in a frequency band of interest;

detecting electrical activity of a digestive system of the user using an electrogastrograph and calculating an electrogastrograph index based on the total energy of the electrogastrograph output in a frequency band of interest; and

detecting an impedance across a portion of the user using an impedance sensor and calculating an impedance sensor index based on the median energy of the impedance sensor output in a frequency band of interest.

17. The method of claim 15, wherein triggering the controlled device comprises causing the controlled device to at least one of:

electrically stimulate tissue of the user;

deliver a therapeutic agent to the user;

deliver a therapeutic agent configured to provoke a release of one or more hormones from L-cells of the user to trigger ileal brake in the user;

deliver insulin to the user;

modulate bile acid levels in the user;

modulate gastric pH levels in the user;

induce an aversive response in the user;

stimulate release of GLP-1 in the user;

activate brown adipose tissue in the user;

adjust a gastric band implanted in the user;

control tonal contractions of the user'"'"'s stomach;

adjust a size or volume of a gastric space occupying device implanted in the user;

modulate gastric emptying in the user;

record a history of the user'"'"'s meal intake events; and

issue an alert to the user or to a caregiver of the user when the user'"'"'s meal intake exceeds a predetermined threshold or deviates from a predetermined pattern.

18. The method of claim 15, wherein said sensing comprises detecting an impedance across a portion of the user using an impedance sensor having a first current electrode, a second current electrode, a first voltage electrode, and a second voltage electrode, and wherein the method further comprises at least one of:

positioning the first current electrode on the user'"'"'s left trapezius muscle, positioning the second current electrode on the user'"'"'s right trapezius muscle, positioning the first voltage electrode on the user'"'"'s chest below the user'"'"'s left clavicle and about half way between the user'"'"'s neck and the user'"'"'s left shoulder, and positioning the second voltage electrode on the user'"'"'s chest below the user'"'"'s right clavicle and about half way between the user'"'"'s neck and the user'"'"'s right shoulder; and

positioning the first current electrode on the user'"'"'s chest below the user'"'"'s left clavicle and about half way between the user'"'"'s neck and the user'"'"'s left shoulder, positioning the second current electrode on the user'"'"'s chest below the user'"'"'s right clavicle and about half way between the user'"'"'s neck and the user'"'"'s right shoulder, positioning the first voltage electrode beneath the first current electrode and inward towards the user'"'"'s sternum, and positioning the second voltage electrode beneath second current electrode and inward towards the user'"'"'s sternum.