Photostimulation method and apparatus in combination with glucose determination

• US 20050054908A1
• Filed: 05/06/2004
• Published: 03/10/2005
• Est. Priority Date: 03/07/2003
• Status: Abandoned Application

• Current Assignee: James R. Henderson, Kevin H. Hazen, Marcy Makarewicz, Mutua Mattu, Stephen L. Monfre, Thomas B. Blank
• Original Assignee: James R. Henderson, Kevin H. Hazen, Marcy Makarewicz, Mutua Mattu, Stephen L. Monfre, Thomas B. Blank
• Inventors: Henderson, James R., Monfre, Stephen L., Hazen, Kevin H., Blank, Thomas B., Mattu, Mutua, Makarewicz, Marcy
• Application Number:
  US10/841,200
• Publication Number:
  US 20050054908A1
• Time in Patent Office: Days
• US Class Current: 600/316
• CPC Class Codes: A61B 2562/146 for optical coupling
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1491 Heated applicators
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/359 using near infrared light

Abstract

A method and apparatus using photo-stimulation to treat or pretreat a sample site prior to analyte concentration determination is presented. More particularly, photo-stimulation at or near at least one sample site is used to enhance perfusion of the sample site leading to reduced errors associated with sampling. Increased perfusion of the sample site leads to increased volume percentages of the target analyte and/or allows the blood or tissue constituent concentrations to more accurately and/or precisely track corresponding sample constituents in more well perfused body compartments or sites such as arteries, veins, or fingertips. In one embodiment, analysis of the photo-stimulated site is used in conjunction with glucose analyzers to determine the analyte concentration with greater ease, accuracy, or precision and may allow determination of the analyte concentration of another non-sampled body part or compartment.

Claims

1. A method for concentration determination of body analytes, comprising the steps of:

using photo-stimulation at or near at least one sample site to enhance perfusion of said sample site, wherein sample constituents more accurately and/or precisely track corresponding blood or tissue constituent concentrations in more well perfused body regions; and

determining analyte concentration based upon measurements made at or near said photo-stimulated site.

2. The method of claim 1, wherein said sample site comprises any of a person'"'"'s forearm, wrist area, upper arm, torso, thigh, and ear.

3. The method of claim 1, wherein said determining step is any of invasive, minimally invasive, and noninvasive.

4. The method of claim 1, wherein said determining step is any of direct and indirect.

5. The method of claim 1, wherein said determining step is based upon any of impedance, chromatographic, electrochemical, and spectroscopic techniques.

6. The method of claim 1, wherein said analyte comprises any of a constituent of blood or of an analyte that tracks the concentration of a blood constituent.

7. The method of claim 1, wherein said analyte comprises any of glucose, fats such as triglycerides or forms of cholesterol, proteins such as albumin or globulin, urea, bilirubin, and electrolytes such as Na⁺, Ca²⁺, and K⁺ or various chelates.

8. An apparatus for photonic stimulation at or near a sample site pursuant to concentration determination of body analytes, comprising:

a photonic source for enhancing perfusion at or near said sample site, wherein sample constituents more accurately and/or precisely track corresponding blood or tissue constituent concentrations in more well perfused body regions; and

means for determining analyte concentration based upon measurements made at or near said photo-stimulated site.

9. The apparatus of claim 8, said photonic source comprising any of one or more LEDs, broadband sources, lasers, diode lasers, and supercontinuous sources.

10. The apparatus of claim 8, wherein said source provides stimulation at about any of 890 and 910 nm.

11. The apparatus of claim 8, wherein said source provides stimulation at a wavelength near a peak absorbance of coupling molecular structures.

12. The apparatus of claim 8, wherein said source stimulates a secondary action beyond heating to induce enhanced perfusion.

13. The apparatus of claim 8, wherein said source comprises:

a broadband source used with at least one optical filter;

wherein said optical filter comprises one or more longpass, shortpass, or bandpass filters that isolate one or more spectral regions.

14. The apparatus of claim 8, wherein said source is configured as any of an individual element, as multiple elements, or as an array.

15. The apparatus of claim 8, wherein said source provides more than one range of wavelengths.

16. The apparatus of claim 8, wherein said source comprises:

a mixture of species of illumination elements

17. The apparatus of claim 8, further comprising:

one or more coupling optics for optimizing the flux of photons at said sample site, said coupling optics comprising alone or in combination any of reflectors, lenses, diffusers, and fiber optics.

18. The apparatus of claim 8, further comprising:

an interface between said photonic source to said sample site.

19. The apparatus of claim 18, said interface comprising any of:

free space optics and coupling optics.

20. The apparatus of claim 8, further comprising:

a guide, comprising a replaceably attached apparatus used as one-half of a lock and key mechanism, for alignment of incident photons from said photonic source relative to said sampling site and/or alignment of a sensor or probing device relative to said sampling site.

21. The apparatus of claim 8, wherein said photonic source is optically attached to said sample site, and wherein said photonic source duty cycle is any of continuous, semi-continuous, or manually activated by a user.

22. An apparatus for photo-stimulation in conjunction with glucose sampling and/or measurement techniques, comprising:

a photonic source for photo-stimulation at or near a sample site to enhance perfusion of said sample site, wherein blood or tissue concentration of glucose more accurately tracks that of any of arterial, venous, fingertip, or well perfused body site glucose concentration; and

means for glucose determination by any of an invasive and a noninvasive technique.

23. The apparatus of claim 22, said means for glucose determination comprising:

a noninvasive analyzer, comprising a source, a sample, light direction optics, at least one detector, means for preprocessing data, and means for using multivariate analysis for glucose concentration determination.

24. The apparatus of claim 22, said photonic source comprising:

a photonic stimulator packaged in a plug that couples into a guide.

25. The apparatus of claim 24, said plug comprises at least one 890 nm LED run off of a battery and that is used to photostimulate said sample site at least prior to a first glucose determination of a day.

26. The apparatus of claim 23, said noninvasive analyzer comprising:

a tungsten halogen source;

an optional backreflector; and

at least one optical filter prior to said sample site, said optical filter used as a heat blocker and/or as an order sorter.

27. The apparatus of claim 22, said photonic source comprising:

a handheld photostimulator for use in conjunction with invasive sampling and/or analysis techniques.

28. The apparatus of claim 22, wherein said sampling sites comprises any of a forearm, wrist area, upper arm, torso, thigh, and ear.

29. The apparatus of claim 22, wherein photostimulation is used prior to traditional glucose concentration analysis and said traditional analysis is on locations which comprise any of a fingertip, base of thumb, plantar regions, or toes.

30. The apparatus of claim 22, further comprising:

a heater for use in conjunction with photo-stimulation to enhance perfusion of said sample site.

31. The apparatus of claim 30, said heater comprising any of:

broadband radiative sources, broadband sources limited by filters to one or more spectral regions, glowbars, LEDs, laser diodes, and lasers.

32. The apparatus of claim 31, said heater comprising:

a tungsten halogen source coupled with one or more longpass, shortpass, or bandpass filters to pass light to said sample site with one or more regions.

33. The apparatus of claim 31, said heater configured to heat different tissue layers via absorbance.

34. The apparatus of claim 22, said means for glucose determination comprising:

means for performing differential measurements comprising any of temporal and/or spatial differential measurements.

35. The apparatus of claim 34, wherein a temporal differential measurement is made by performing an analysis before, during, and/or after photostimulation.

36. The apparatus of claim 34, wherein differential measurements are used to determine the impact of photostimulation on said sample site.

37. The apparatus of claim 34, wherein a spatial differential measurement is made by performing an analysis at two sites, wherein a first site is treated by photostimulation and a second site is left untreated, wherein both analyses are performed at the same time or close in time.

38. An apparatus for photo-stimulation in conjunction with analyte sampling and/or measurement techniques, comprising:

a photonic source for photo-stimulation at or near a sample site to enhance perfusion of said sample site, wherein blood or tissue concentration of said analyte more accurately tracks that of any of arterial, venous, fingertip, or well perfused body site analyte concentration; and

means for analyte determination.

39. The apparatus of claim 38, said means for analyte determination comprising:

means for any of noninvasive glucose, urea, cholesterol, blood gas, oxygen, or pH determination.

40. The apparatus of claim 38, further comprising:

a lock and key mechanism associated with said photonic source and replaceably attached to said sample site.

41. The apparatus of claim 40, wherein at least one of said lock and said key is profiled to the structure of said sample site.

42. The apparatus of claim 40, said lock and key mechanism comprising:

a guide coupled to a plug, wherein said plug comprises a plurality of LEDs.

43. The apparatus of claim 42, said lock and key mechanism comprising:

one or more magnets for effecting reproducible alignment between said guide and said plug.

44. The apparatus of claim 42, wherein said LED'"'"'s are automatically turned on when said plug is placed into said guide.

45. The apparatus of claim 38, wherein said means for analyte determination comprises an invasive technique.

46. The apparatus of claim 38, wherein said means for analyte determination comprises a noninvasive technique.

47. The apparatus of claim 38, wherein said means for analyte determination comprises a minimally invasive technique.