Process and device for detecting the exchange of heat between the human body and the invented device and its correlation to the glucose concentration in human blood

• US 5,924,996 A
• Filed: 04/29/1997
• Issued: 07/20/1999
• Est. Priority Date: 07/06/1994
• Status: Expired due to Term

• Current Assignee: Ok Kyung Cho, PhiScience GmbH
• Original Assignee: Ok Kyung Cho
• Inventors: Cho, Ok Kyung, Holzgreve, Birgit
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/765,252
• Time in Patent Office: 812 Days
• Field of Search: 600/309, 600/316, 600/347, 600/365, 600/412, 600/474, 600/549
• US Class Current: 600/549
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G01K 13/20 Clinical contact thermometers for use with humans or animals

Abstract

A process and device are disclosed for sensing the thermal interaction between the human body and the disclosed device. The thus obtained physical measurement data are electronically converted and may be associated in an appropriate manner to concentrations of certain components of human blood determined in an unambiguous manner, such as cholesterol, triglycerides, etc., in particular glucose. The device has at least one heat measurement unit and electronic control, regulation, evaluation and output units. The device also allows temperature measurements with high spatial and temporal resolutions. The process is non-invasive and is particularly suitable for determining without contact the glucose concentration in parts of the human body, in particular human blood.

Claims

1. A process for qualitative and quantitive detection of thermal transmissions between a living body and a sensor via measurement processes for determining at least one of a temperature and temperature change using radiation sources and detectors both for contactless and contact measurement, the process comprising the steps of:

physically detecting with high precision thermal interactions within a thermodynamic system composed of the sensor, the living body, and any space arranged therebetween via a combination of said measurement processes;

electronically numerically converting the physically detected thermal interactions using a processor;

evaluating said electronically numerically converted thermal interactions via said processor; and

assessing and unequivocally allocating the evaluated electronically numerically converted thermal interactions to a glucose concentration in human blood via a mathematical algorithm.

2. The process according to claim 1, wherein the physically detecting step detects heat radiated from at least one of a surface of the body in a layer close to the surface, in body cavities, in a deeper resolving manner such as via specific heat radiating from below the surface inside the living body, said heat being transmitted and radiated to said sensor such that measured data obtained thereby is unequivocally correlated to the glucose concentration in the human blood.

3. The process according to claim 1, wherein said thermal interactions between the living body and the sensor are relatively calculated using at least one reference value.

4. The process according to claim 3, wherein said thermal interactions are also calculated using data processing from temperature differences and temperature quotients, and from their mathematical conversions, derivations and integrals, wherein said thermal interactions are allocated via the mathematical algorithm unequivocally to the specific glucose concentration of the human blood.

5. The process according to claim 4, wherein said temperature differences and temperature quotients are obtained by applying at least one of the contact and contactless measurement process in as precise a manner as possible.

6. The process according to claim 1, further comprising the steps of:

utilizing measured values gained prior to and following measurements as blank values, and even directly as data for calibration and analysis for formation of temperature difference and/or temperature quotients.

7. The process according to claim 1, wherein at least one of a temperature difference and a temperature quotient is allocated to the glucose concentration, said temperature difference and temperature quotient not exceeding an amount of ±

33K of the measured temperature in or on a casing of the sensor serving as a reference temperature.

8. The process according to claim 1, wherein a temperature measured at one or more specific and/or random sites in and on the sensor casing is utilized as a reference temperature for formation of at least one of a temperature difference and temperature quotient amount.

9. The process according to claim 1, wherein an air, gas, or vacuum temperature measured in/at the sensor casing is usable as a background temperature which is utilized as a reference temperature.

10. The process according to claim 9, wherein a respective background temperature is gained with the aid of the measured values made prior to and following measurements made by sensor heads of the sensor.

11. The process according to claim 1, wherein an interfering influence of room temperature is compensated as the temperature is integrated in the mathematical evaluation algorithm.

12. The process according to claim 11, wherein said compensation occurs one of automatically, semi-automatically, and manually.

13. The process according to claim 12, wherein a momentary temperature of the to be examined living body is integrated as a fixed value in said assessment and evaluation steps.

14. The process according to claim 1, wherein the analysis algorithm is controlled selectively dependent on, or independent of, the living bodies being measured.

15. The process according to claim 1, wherein the analyses results are determined matrix-effect-free independent of individuals with the aid of at least one main function and/or at least one or more auxiliary functions.

16. The process according to claim 1, wherein the mathematical algorithm is a linear regression procedure having one independent variable in a first or higher order forming a basis.

17. The process according to claim 1, wherein the mathematical algorithm is a linear regression procedure having two or more independent variables in a first or higher order forming a basis.

18. The process according to claim 1, wherein a temperature difference/quotient caused by and depending on a respective individual and his/her state of health is determined via an auxiliary function from two temperatures measured independently, simultaneously or time-staggered, spatially and/or time-resolved, and is applied as an individual compensation factor.

19. The process according to claim 1, wherein for evaluation, only temperature differences and/or temperature quotients caused by heat conduction or by weakened heat conduction or by heat radiation or a combination of all the determined thermal processes are utilized.

20. The process according to claim 1, wherein a measurement peak is detected automatically with the aid of a function.

21. The process according to claim 1, wherein only a relevant portion of the measurement signal is utilized for evaluation.

22. The process according to claim 21, wherein a minimal and maximum value of said relevant measurement signal portion is detected and the temperature difference and/or temperature quotient of both values are determined for said heat radiation as well as for said heat conduction and for said weakened heat conduction.

23. The process according to claim 1, wherein for said temperature difference and/or temperature quotient formation, the heat radiating from the human body transmitted via the contact surface of said sensor is completely determined, specifically or selectively for said temperature radiation, said heat conduction and said weakened heat conduction in and on said sensor casing, said heat being registered.

24. The process according to claim 1, wherein the heat radiating and/or emitting from the living body is separated according to its different nature thermoanalytically, according to wavelength or according to frequency.

25. The process according to claim 1, wherein a Fourier transformation is utilized for the mathematical evaluation.

26. The process according to claim 1, wherein heat radiation, for one or more than one specific frequency interval is integrated and said frequency interval is linked, independently of one another and/or dependent on each other, for evaluation by being pretreated in a suitable mathematical manner such as by being differentiated or integrated over time.

27. The process according to claim 1, wherein heat radiation in a wavelength range of 3-30 μ

m is measured.

28. The process according to claim 1, wherein sensitivity is improved using a lock-in procedure.

29. The process according to claim 28, wherein a signal amplitude is in the range of 1 μ

V to 10 mV.

30. The process according to claim 28, wherein a signal-to-noise ratio is raised by a factor of 1000.

31. The process according to claim 1, wherein semiconductor materials such as germanium or silicon are utilized as detectors for heat radiation and heat conduction in the sensor.

32. The process according to claim 1, wherein pyroelectric detectors are utilized as said detectors for heat radiation and heat conduction in the sensor.

33. The process according to claim 1, wherein all solid state liquids and gases, the thermal conductivity of which has a value larger than zero, are employed as receivers for heat radiation and heat conduction.

34. The process according to claim 1, wherein an interaction between the human body and the microwave radiation is exploited.