CHANNELED TISSUE SAMPLE PROBE METHOD AND APPARATUS

• US 20090318786A1
• Filed: 04/25/2008
• Published: 12/24/2009
• Est. Priority Date: 03/08/2002
• Status: Abandoned Application

• Current Assignee: GLT Acquisition Corporation
• Original Assignee: GLT Acquisition Corporation
• Inventors: MONFRE, Stephen L., RUCHTI, Timothy L., BROWN, Sedar, HAZEN, Kevin H., SLAWINSKI, Christopher, BLANK, Thomas B.
• Application Number:
  US12/110,183
• Publication Number:
  US 20090318786A1
• Time in Patent Office: Days
• US Class Current: 600/322
• CPC Class Codes: A61B 2562/146 for optical coupling
• 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: G01N 21/359 using near infrared light

Abstract

Sampling is controlled in order to enhance analyte concentration estimation derived from noninvasive sampling. More particularly, sampling is controlled using controlled fluid delivery to a region between a tip of a sample probe and a tissue measurement site. The controlled fluid delivery enhances coverage of a skin sample site with the thin layer of fluid. Delivery of contact fluid is controlled in terms of spatial delivery, volume, thickness, distribution, temperature, and/or pressure.

Claims

1. A spectroscopic analyzer apparatus for noninvasive analyte property determination from a sample site of a body part, comprising:

a sample probe having a sample probe tip;

an optic penetrating through said sample probe and terminating at said sample probe tip; and

at least one microfluidic fluid delivery channel defined in said sample probe tip, said channel forming a pathway for dispersion of a coupling fluid when said sample probe tip proximately contacts the body part.

2. The apparatus of claim 1, said channel further comprising:

an inner moat circumferentially surrounding a center of said sample probe tip.

3. The apparatus of claim 2, further comprising:

an outer moat in said sample probe tip circumferentially surrounding said inner moat.

4. The apparatus of claim 2, further comprising:

a fluid delivery aperture defined by extending and through said sample probe tip and terminating proximate said inner moat, said aperture conducting a coupling fluid from a reservoir to said inner moat.

5. The apparatus of claim 4, said aperture further comprising:

a hydrophilic coating.

6. The apparatus of claim 1, said microfluidic channel comprising:

at least one channel extending radially outward from a center of said sample probe tip.

7. The apparatus of claim 1, said microfluidic channel comprising:

at least one channel extending axially outward along an x-axis from the sample site, wherein said x-axis runs along the length of the body part.

8. The apparatus of claim 1, said microfluidic channel comprising:

at least one channel extending axially outward along a y-axis from the sample site, wherein said y-axis runs across the body part.

9. The apparatus of claim 1, said microfluidic channel comprising:

a plurality of channels on an x,y-plane of said sample probe tip, wherein said x,y-plane tangentially touches the body part.

10. The apparatus of claim 9, wherein said at least one channel merges with the body part during use to form at least one circumferentially enclosed fluid delivery path.

11. The apparatus of claim 9, wherein said plurality of channels interconnect.

12. The apparatus of claim 1, further comprising a reservoir located within said analyzer, wherein said reservoir connects to said sample probe tip via tubing running through said sample probe tip.

13. The apparatus of claim 12, further comprising:

a processor programmed to use a sensor feedback to effect delivery of fluid from said reservoir to said sample probe tip in less than ten seconds from acquisition of a noninvasive spectrum of the body part with said analyzer.

14. The apparatus of claim 13, wherein said sensor comprising:

a pressure sensor associated with to said sample probe.

15. The apparatus of claim 1, further comprising:

an active heater for maintaining said optic between about eighty-five and about ninety-three degrees Fahrenheit.

16. The apparatus of claim 1, further comprising:

means for delivering coupling fluid from a reservoir, through said sample probe tip, to said delivery channel.

17. The apparatus of claim 1, further comprising:

a pressure sensor integrated into said sample probe tip, wherein said pressure sensor comprises a film having air voids, said film having a capacitive charge, wherein application of a force onto said film compresses said film, resulting in change of said capacitive charge that is indicative of said force.

18. The apparatus of claim 1, wherein said at least one microfluidic fluid delivery channel is machined into said tip of said sample probe at a depth of less than about one hundred micrometers and with a cross sectional distance of less than about one hundred micrometers.

19. A method for delivering a fluid to a sample site, comprising the step of:

delivering fluid from a reservoir to microchannels machined into a sample probe tip of an optical analyzer, wherein said microchannels form passages for fluid to flow through when said sample probe tip proximately contacts the sample site.

20. The method of claim 19, wherein said step of delivering moves the fluid from said reservoir through at least one lumen embedded in said sample probe to said sample probe tip.

21. The method of claim 20, further comprising the step of:

moving said sample probe tip into proximate contact with the sample site during use.

22. The method of claim 21, wherein said proximate contact comprises a distance of less than about 0.25 millimeters, and wherein said sample probe tip does not contact the sample site.

23. The method of claim 20, wherein said proximate contact comprises a distance resulting in, upon flow of fluid through microchannels, negative pressure sufficient to draw said sample probe tip into contact with the sample site.

24. The method of claim 19, further comprising the steps of:

acquiring a near-infrared optical spectrum in the range of about 1100 to 1900 nm with said analyzer;

selecting an algorithm to analyze said signal based if a transient response is observed in said spectrum; and

determining a glucose concentration from said spectrum using said selected algorithm.

25. The method of claim 19, further comprising the step of:

maintaining fluid temperature from about 85 to about 93 degrees Fahrenheit prior to delivery of the fluid to said microchannels.

26. The method of claim 19, further comprising the step of:

wirelessly communicating a spectrum acquired from said sample probe tip to a base module of said analyzer.

27. The method of claim 19, said fluid comprising:

a viscosity of less than about twelve centistokes; and

a refractive of less than about 1.33.

28. The method of claim 19, wherein said coupling fluid comprising:

a fluid substantially formed from carbon atoms and fluorine atoms, wherein said carbon atoms comprises chain lengths of less than about twenty carbon atoms.

29. The method of claim 21, wherein said step of moving moves said sample probe tip along a z-axis aligned with gravity

30. The method of claim 21, wherein said step of moving moves said sample probe tip along an axis normal to an x,y-plane, wherein said x,y-plane defined a plane tangentially contacting the sample site, wherein said axis normal to said x,y-plane is not aligned with gravity.

31. The method of claim 21, wherein said step of delivering delivers said fluid during said step of moving.

32. The method of claim 21, wherein said step of delivering is performed both before said step of moving and after said step of moving.

33. The method of claim 21, further comprising the steps of:

acquiring a control signal, that is indicative of a distance between said sample probe tip and the sample site; and

using said control signal in a feed back control loop to control one or more of said steps of delivering and moving.

34. The method of claim 19, wherein said step of delivering delivers less than about thirty microliters of fluid to said microchannels within ten seconds of initiation of collection of a noninvasive scan of the sample site using said optical analyzer.

35. The method of claim 19, said channels comprising:

a plurality of channels axially extending from about a center of said sample probe tip.

36. The method of claim 19, wherein said channels extend radially from about a center of said sample probe tip.

37. The method of claim 19, wherein said channels are machined into said tip of said sample probe at a depth of less than about one hundred micrometers and with a cross sectional distance of less than about one hundred micrometers.

38. The method of claim 19, further comprising the steps of:

collecting a near-infrared noninvasive spectrum at the sample site at least within the range of 1100 to 1900 nm; and

applying a hybrid calibration to said spectrum to generate a glucose concentration prediction.

39. The method of claim 38, wherein said hybrid calibration model combines results from a plurality of individual models, wherein each of said plurality of models are constructed using spectra having any of:

sample probe tissue interface wetting variation;

varying magnitude of tissue stretch of the sample site; and

non-tangency of contact between a tip of a sample probe and the sample site.

40. The method of claim 38, wherein said hybrid calibration model combines results from a plurality of individual models, said individual models having a localized net analyte signal peak that is attenuated according to sample type, wherein said sample type comprises any of

sample probe tissue interface wetting variation;

varying magnitude of tissue stretch of the sample site; and

non-tangency of contact between a tip of a sample probe and the sample site.

41. The method of claim 38, wherein said hybrid calibration model combines results from a plurality of individual models, each of said individual models generating a determination, said determinations weighted according to covariance of spectra, said spectra collected through repetition of said step of collecting.

42. The method of claim 38, wherein said hybrid calibration model combines results from a plurality of individual models, each of said individual models having distinct net analyte signal peak magnitude position in the wavelength region of about 1520 to 1560 nm.