Diagnostic Sensors and/or Treatments for Gastrointestinal Stimulation or Monitoring Devices

• US 20110251495A1
• Filed: 09/10/2010
• Published: 10/13/2011
• Est. Priority Date: 09/10/2009
• Status: Abandoned Application

• Current Assignee: IntraPace, Inc.
• Original Assignee: IntraPace, Inc.
• Inventors: Potosky, John C., Province, Rose, Brynelsen, Charles R.
• Application Number:
  US12/879,523
• Publication Number:
  US 20110251495A1
• Time in Patent Office: Days
• US Class Current: 600/483
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Methods, systems and devices for monitoring the health and energy expenditure of a living body, treating patients with an eating disorder or treating obese patients are described. The methods, systems and devices described may also be applicable to any treatment in which presenting feedback regarding patients'"'"' eating and exercise habits is desired. The present invention provides for treating a patient by collecting ingestion and exercise information about the patient from implanted sensors and communicating the collected information to the patient and/or to their health care provider(s). In some embodiments, stimulation of the patient'"'"'s stomach is also provided to reduce caloric intake.

Claims

1. A method for monitoring health of a living body, the method comprising:

implanting a plurality of sensors within the body so that the sensors generate signals correlating to energy expenditure of the body, a first set of the signals during a first portion of a time span indicating a first rate of energy expenditure of the body, a second set of the signals during a second portion of the time span indicating a second rate of energy expenditure greater than the first energy expenditure;

calculating an overall caloric energy expenditure of the body for the time span using the signals such that the calculated overall energy expenditure correlates to the first energy expenditure over the first time portion combined with the second energy expenditure over the second time portion; and

at least one of displaying the calculated overall energy expenditure or treating the body in response to the calculated overall energy expenditure.

2. The method of claim 1, wherein the sensors transmit the signals from within the body for more than a month, and wherein the displaying of the calculated overall energy expenditure or the treating of the body in response to the overall energy expenditure are performed so as to induce a desired improvement in the health of the body while the sensors are implanted in the body.

3. The method of claim 1, wherein the sensors transmit the signals from within the body for a plurality of months, wherein the body comprises a patient having an eating disorder, and wherein the displaying of the calculated overall energy expenditure or the treating of the body in response to the calculated overall energy expenditure is performed such that the eating disorder of the patient is mitigated.

4. The method of claim 1, wherein the sensors comprise an implanted triaxial accelerometer and an implanted heart rate sensor.

5. The method of claim 4, wherein an activity level of the body during the first time portion is determined to be within a sedentary range and the activity level during the second time portion is determined to be within an active range, and wherein the overall energy expenditure is calculated using a regression relationship corresponding to a sedentary range for the first time portion and a regression relationship corresponding to an active range different than the sedentary range regression relationship for the second time portion.

6. The method of claim 5, wherein the ranges of the activity levels are determined in response to a comparison between an integration of accelerometer signals and a threshold, wherein the overall energy expenditure corresponds to, for each time portion, an intensity of the activity level multiplied by a time period of the associated time portion, wherein each intensity corresponds to a combination of an accelerometer-based intensity portion with a heart-rate based intensity portion, and wherein relative contributions of the intensity portions vary per the determined range of intensity level.

7. The method of claim 5, wherein the activity level during the second time portion comprises a vigorous activity level, and further comprising identifying at least one portion of the time span associated with a moderate activity level and at least one portion of the time span associated with a light activity level, wherein, for each time portion of the span, associated energy expenditure portions are calculated using an energy expenditure intensity factor determined using an activity level of that time period, and wherein the overall energy expenditure is calculated by combining the energy expenditure portions throughout the time span.

8. The method of claim 4, wherein the sensors further comprise an implanted core body temperature sensor.

9. The method of claim 8, further comprising identifying a sleeping period, sedentary waking period, and an active energy period in response to the core body temperatures, wherein the overall energy expenditure corresponds to a sleeping energy expenditure portion determined using the sleeping period, a sedentary waking energy expenditure portion determined using the sedentary waking period, and an active energy expenditure portion determined using the active period.

10. The method of claim 9, wherein the core body temperature sensor is disposed in a stomach cavity of the body so that the core body temperature sensor serves as an ingestion sensor, wherein ingestion is identified using rapid temperature changes and sleep is identified using a shift in steady-state temperature while activity is consistent with sleep.

11. The method of claim 8, further comprising determining ingestion into the body with an ingestion sensor disposed in a stomach cavity of the body, the core body temperature sensor being thermally separated from the ingestion sensor.

12. The method of claim 1, further comprising determining a quantified caloric content of ingestion into the body during the time span, and graphically displaying the overall energy expenditure and the caloric ingestion to the body while the sensors are implanted within the body so as to influence health behavior by the living body.

13. The method of claim 1, further comprising stimulating tissue of the body so as to inhibit unhealthy ingestion habits into the body in response to the signals.

14. The method of claim 13, wherein unhealthy ingestion habits comprise ingestion of food in excess of an average daily caloric requirement or goal for the living body.

15. A method for monitoring health of a living body, the method comprising:

coupling an accelerometer to the body so as to generate accelerometer signals in response to movement of the body;

coupling a heart rate sensor to the body so as to generate heart rate signals in response to a heart rate of the body; and

calculating an overall caloric energy expenditure of the body for a time span using the signals such that, for a plurality of time portions of the span, associated energy expenditure rates are identified from the signals.

16. The method of claim 15, the method comprising displaying the calculated hourly, daily, and monthly overall caloric expenditure.

17. A method for monitoring health of a living body, the method comprising:

coupling an accelerometer to the body so as to generate accelerometer signals in response to movement of the body;

coupling a heart rate sensor to the body so as to generate heart rate signals in response to a heart rate of the body;

coupling a core body temperature sensor to the body so as to generate temperature signals in response to a core temperature of the body; and

calculating an overall caloric energy expenditure of the body for a time span using the signals such that, for a plurality of time portions of the span, associated energy expenditure rates are identified from the signals.

18. The method of claim 17, wherein the overall energy expenditure of the body is calculated by identifying a plurality of activity levels of the body from the signals, wherein the identified activity levels include sleep and wherein a sleep period is determined using the temperature signals.

19. The method of claim 17, wherein the overall energy expenditure of the body is calculated by identifying a plurality of activity levels of the body from the signals, wherein the identified activity levels include sleep, wherein the sleep period is determined using the accelerometer and temperature signals.

20. A system for monitoring health of a living body, the system comprising:

a plurality of implantable sensors, each sensor generating signals correlating to energy expenditure of the body when implanted therein;

a processor coupleable to the sensors so that the processor, in response to the signals, calculates an overall caloric energy expenditure, wherein the processor is configured to, in response to a first set of the signals during a first portion of a time span determine a first rate of energy expenditure of the body, and in response to a second set of the signals during a second portion of the time span determine a second rate of energy expenditure greater than the first energy expenditure, and to calculate the overall energy expenditure by combining the energy expenditure rates with their associated time periods; and

a display or treatment signal applicator coupled to the processor so as to receive the overall energy expenditure and display the overall energy expenditure of the body or apply treatment signals to the body.

21. The system of claim 20, wherein each sensor is configured to transmit signals from within the body for at least a month, and wherein at least one of the displaying of the calculated overall energy expenditure and the treating of the body in response to the overall energy expenditure are performed so as to induce a desired improvement in the health of the body while the sensors are implanted within the body.

22. The system of claim 20, wherein each sensor is configured to transmit signals from within the body for a plurality of months, and wherein the body comprises a patient having an eating disorder, and wherein at least one of the displaying of the calculated overall energy expenditure and the treating of the body in response to the calculated overall energy expenditure is performed such that the eating disorder is mitigated.

23. The system of claim 20, wherein the implantable sensors comprise an accelerometer, a heart rate sensor, and a body temperature sensor.

24. The system of claim 23, wherein the accelerometer comprises a triaxial (3D) accelerometer.

25. The system of claim 23, wherein the processor is configured to identify a sleeping period in response to a core body temperature signal from the temperature sensor, wherein the overall energy expenditure corresponds to a sleeping energy expenditure portion determined using the sleeping period, a sedentary waking energy expenditure portion determined using the sedentary waking period, and an active energy expenditure portion determined using the active period.

26. The system of claim 25, wherein the temperature sensor is disposed in the stomach cavity of the body so that the sensor serves as an ingestion sensor to detect food consumption based on a rapid shift in homeostatic temperature while activity is consistent with the sleeping period.

27. The system of claim 20, wherein the caloric content of ingestion into the body during the time span is quantified and the overall energy expenditure and caloric ingestion into the body is graphically displayed while the sensors are implanted within the body.

28. The system of claim 20, further comprising a stimulator to stimulate tissues of the body so as to inhibit unhealthy ingestion into the body in response to the signals.

29. A system for treating an eating disorder of a patient, the system comprising:

an accelerometer coupleable to the body so as to generate accelerometer signals in response to movement of the body;

a heart rate sensor coupleable to the body so as to generate heart rate signals in response to a heart rate of the body;

a core body temperature sensor coupleable to the body so as to generate temperature signals in response to a core temperature of the body; and

a processor coupleable to the sensors so that the processor, in response to the signals, calculates an overall caloric energy expenditure of the body for a time span using the signals by, for each of a plurality of time portions of the span, identifying an associated energy expenditure rate from the signals.

30. The system of claim 29, wherein the sensor data includes ingestion and activity level information.

31. The system of claim 30, wherein the overall energy expenditure of the body is calculated by identifying a plurality of activity levels of the body from the signals, wherein the identified activity levels include sleep and wherein a sleep period is determined using the temperature signals.

32. The system of claim 31, wherein identifying a plurality of activity levels of the body from the signals includes determining sleep onset based on reduced levels of accelerometer based activity, heart rate, and core body temperature.

33. The system of claim 29, wherein the accelerometer is implanted in the body of the patient.

34. The system of claim 29, wherein the transmitted signals of the accelerometer are sampled at adaptive and varying rates so as to conserve system power requirements and increase resolution of body movement.

35. The system of claim 29, wherein the accelerometer comprises an omni-directional accelerometer so as to provide greater sensitivity in detecting periods of low activity.

36. A system for treating an obese patient, the system comprising:

an implantable device having at least one sensor, the device configured to collect patient data with the sensor(s) in response to ingestion by the patient and/or in response to exercise by the patient when the device is implanted in a patient body;

a processor coupleable to the implantable device so as to, in response to the patient data, analyze the patient data to determine sensor-based ingestion information and sensor-based exercise information about the patient; and

a treatment applicator or display coupled to the processor so as to receive the information about the patient and encourage at least one of healthy eating and exercise behavior by the patient.

37. The system of claim 36, wherein the treatment applicator of the implantable device is configured to stimulate tissues of the body so as to inhibit unhealthy ingestion into the body in response to patient data.

38. The system of claim 37, wherein the implantable device is configured to stimulate tissues of the body so as to trigger a feeling of satiety or nausea in the patient.

39. The system of claim 36, wherein the patient data is transmitted from the sensor(s) via wireless electrical signals to the processor.

40. The system of claim 36, wherein the sensor comprises any one or more of an accelerometer, a heart rate sensor, an optical sensor, a heat-flux sensor, a tilt sensor and a core body temperature sensor.

41. The system of claim 40, wherein the tilt sensor is configured to collect data during various postural allocations of the obese patient and configured to evaluate non-exercise activity thermogenesis (NEAT) related energy expenditure.

42. A system of claim 40, wherein the accelerometer is configured to collect data during various exercise levels of the obese patient and arranged to be calibrated based on the collected data and a linear relationship between an integral of absolute value of the accelerometer output (IAA_tot) and a metabolic equivalent (METS)-1.

43. A method for monitoring the energy expenditure of a living body, the method comprising:

coupling an accelerometer to the body so as to generate accelerometer signals in response to movement of the body so that accelerometer signals are collected during various body movements and calibrated based on a linear relationship between an integral of absolute value of accelerometer output (IAA_tot) and a metabolic equivalent (METS)-1;

coupling a heart rate sensor to the body so as to generate heart rate signals in response to a heart rate of the body;

coupling a core body temperature sensor to the body so as to generate temperature signals in response to a core temperature of the body;

calculating an overall caloric expenditure of the body for a time span using the signals such that, for a plurality of time portions of the span, associated energy expenditure rates are identified from the signals; and

displaying the calculated overall energy expenditure or treating the body in response to the calculated overall energy expenditure.

44. The method of claim 43, wherein the accelerometer signals are sampled using a first rate and a second rate, wherein sampling is increased from the first rate to the second rate when the accelerometer exceeds a predetermined threshold.

45. A device for monitoring a living body comprising:

a plurality of sensors configured to be disposed within the body, the sensors configured to emit signals correlating to a energy expenditure of the body;

a means for calculating caloric expenditure of the body during a time span in response to the signals; and

a means for displaying the caloric expenditure calculation to the body while the body contains the sensors.

46. The device of claim 45, wherein the sensors comprise at least one heat flux sensor configured to be implanted underneath an epidermis layer of a skin.

47. The device of claim 45, wherein the sensors comprise at least one temperature sensor configured to be implanted underneath an epidermis layer of a skin, at the juncture of several capillaries into a larger blood vessel.

48. An apparatus for monitoring a living body comprising:

a power source;

a plurality of implantable sensors coupled with the power source, the sensors comprising;

an accelerometer;

a heart rate sensor;

a body temperature sensor configured to implant in a stomach cavity of the body;

a processor configured to calculate a caloric expenditure and an ingestion event of the body during a time span in response to the signals;

a stimulator positioned in electrical contact with the stomach;

wherein the stimulator is connectable to the processor; and

a display coupled with the sensors and the processor.