CORE BODY TEMPERATURE SYSTEM

• US 20160331244A1
• Filed: 05/11/2016
• Published: 11/17/2016
• Est. Priority Date: 05/12/2015
• Status: Abandoned Application

• Current Assignee: Razzberry, Inc.
• Original Assignee: Razzberry, Inc.
• Inventors: Barton-Sweeney, Alexandra
• Application Number:
  US15/151,909
• Publication Number:
  US 20160331244A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: A61B 2010/0019 based on measurement of temperature
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/0242 adapted to measure environmental factors, e.g. temperature, pollution
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/0008 Temperature signals
• 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 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/4857 Indicating the phase of biorhythm clocks or watches with indicators for biological cycles G04B19/264
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A system and method are provided for determining a core body temperature or a physiological function. The system and method includes using multiple sensors in combination with analytic techniques.

Claims

1. A method to determine a physiological function result, comprising:

determining the temperature of a first body location on a subject to obtain a first body temperature value;

optionally determining the temperature of a second body location on a subject to obtain a second body temperature value;

optionally determining the ambient temperature to determine an ambient temperature value;

obtaining a physiological function result from a predetermined prediction equation, wherein the obtaining comprises a comparison of the amplitude of the temperature values, the mesor of the temperature values, the mean of the temperature values, the peak of the temperature values, the nadir of the temperature values, or the acrophase of the temperature values, or a combination comprising one or more of the foregoing.

2. The method of claim 1, wherein the obtaining comprises inputting the temperature values into the predetermined prediction equation.

3. The method of claim 1, further comprising determining a temperature value at more than one time.

4. The method of claim 1, wherein the predetermined prediction equation further comprises a comparison of changes of amplitude of the temperature values over time.

5. The method of claim 1, wherein the predetermined prediction equation further comprises a cyclic rhythm parameter.

6. The method of claim 5, wherein the cyclic rhythm parameter is a circadian rhythm, sleep-wake cycles, activity rhythms, circannual rhythm, circa mensal rhythm, or a combination comprising one or more of the foregoing.

7. The method of claim 1, wherein the predetermined prediction equation further comprises masking parameters, entraining agent parameters, or both.

8. The method of claim 1, wherein the predetermined prediction equation further comprises cyclical changes in thermogenic processes.

9. The method of claim 1, wherein the predetermined prediction equation further comprises a personal parameter, wherein the personal parameter comprises age, gender, menstrual cycle day, chronotype, height, weight, fat percentage, body mass index, lean body mass, body size proportions, drug use (e.g. hormonal contraceptive), dietary intake, alcohol consumption, time zone, or a combination comprising one or more of the foregoing.

10. The method of claim 1, wherein the physiological function result is a fertility parameter or a metabolic function parameter.

11. The method of claim 1, wherein the physiological function result is a determination of if the subject is in a thermoneutral zone.

12. The method of claim 10, wherein the fertility parameter is a level of fertility.

13. The method of claim 12, wherein the metabolic function parameter is an infection, or the presence of a fever.

14. The method of claim 10, wherein the metabolic function parameter is thyroid function, cholesterol amount, pituitary function, gonadal function, adrenal function, hypoglycemia, pancreatitis, drug or alcohol abuse, kidney function, liver function, cardiovascular function, organ failure, thermoregulation function, heat balance, heat distribution, central nervous system function, metabolic toxicities, reproductive stage, fibromyalgia.

15. The method of claim 1, wherein the physiological function result is a determination of whether the subject is in a synchronized or desynchronized state in relation to chronobiological rhythms.

16. The method of claim 1, wherein the physiological function result is a determination of a health state, such as a normal, abnormal, or diseased state.

17. The method of claim 16, wherein the health state is an indicator of abnormalities, such as brain lesions, cancer progression, Human Immunodeficiency Virus (HIV) acquired immune syndrome (AIDS) progression, cancer treatment efficacy, allergies, depression, psychological or neurological states, anxiety, concussion, head trauma, thyroid imbalances, febrile state.

18. The method of claim 1, wherein the temperature values are input into one or more mathematical models comprising historical or population data related to one or more of the following:

healthy, abnormal, or diseased states based on individual data, historical data or population data.

19. The method of claim 1, wherein the determining is performed periodically.

20. The method of claim 1, wherein the first body location is distal to the core, and the second body location is proximal to the core and wherein the difference between the first and second temperature values is a first distal to proximal temperature gradient;

the method further comprising;

optionally repeating the determining steps to determine a second distal to proximal temperature gradient;

inputting the first and second distal to proximal temperature gradient in a predetermined physiological function equation to obtain a physiological function result.

21. The method of claim 20, further comprising inputting the first and second distal to proximal temperature gradient into a predetermined prediction equation to approximate a body temperature, such as a core body temperature, a peripheral temperature, or a regional body temperature.

22. The method of claim 20, wherein the predetermined prediction equation further comprises the distance of the first or second body location to the core.

23. The method of claim 20, wherein the predetermined prediction equation further comprises the distance between the first and second body location.

24. The method of claim 1, wherein the predetermined prediction equation uses the change of amplitude of the first body temperature value and optionally the second body temperature value to determine a predicted body temperature.

25. The method of claim 1, wherein the predetermined prediction equation uses the change of amplitude of the second body temperature value to determine a predicted core body temperature.

26. The method of claim 1, wherein the physiological function result further comprises comparison of a change in amplitude of the temperature values compared to historical data or cyclic patterns based on historical data or population data, to determine a physiological function result.

27. The method of claim 1, further comprising determining the heart rate.

28. A system for determining a health state, comprising:

two or more sensors, each sensor comprising;

a membrane configured to be applied to an external surface of a body of a subject;

one or more temperature monitors configured to detect and/or measure a temperature, each monitor located within the sensor in thermal contact with the membrane;

optionally, a transmitting apparatus configured to transmit the output from the one or more temperature monitors;

a power source configured to apply power to the one or more temperature sensors and the transmitting apparatus;

optionally, an ambient environmental monitor configured to detect and/or measure an environmental condition in a vicinity of a subject;

a processing unit configured to receive and process signals produced by the temperature monitors and optional ambient environmental monitor, to determine time-dependent parameters of temperature change, and to calculate a body temperature, such as a core body temperature, a regional body temperature, or a peripheral body temperature.

29. The system of claim 28, further comprising an indicator on the device that can be viewed or heard by the subject.

30. The system of claim 28, wherein the processing unit is further configured to determine a physiological function result.

31. A kit for determining a health state, comprising:

one or more sensors, each sensor comprising;

a membrane configured to be applied to an external surface of a body of a subject;

one or more temperature monitors configured to detect and/or measure a temperature, each monitor located within the sensor in thermal contact with the membrane;

a transmitting apparatus configured to transmit the output from the one or more temperature monitors;

a power source configured to apply power to the one or more temperature sensors and the transmitting apparatus;

optionally, an ambient environmental monitor configured to detect and/or measure an environmental condition in a vicinity of a subject;

instructions for using the one or more sensors, the instructions comprising access to a processing unit configured to receive and process signals produced by the temperature monitors and optional ambient environmental monitor, to determine time-dependent parameters of temperature change, and to calculate a core body temperature.

32. The kit of claim 31, wherein the instructions further comprise access to a local or remote storage medium to obtain information about the health state.

33. The kit of claim 31, wherein the local or remote storage medium comprises a predetermined prediction equation configured to obtain a physiological function result.

34. A method to calibrate the sensors using input of other physiological data.

35. The method of claim 34, wherein the other physiological data comprises oral, ear, forehead, or rectal temperature measurements.