Sampling interface system for in-vivo estimation of tissue analyte concentration

• US 20050187439A1
• Filed: 01/06/2005
• Published: 08/25/2005
• Est. Priority Date: 03/07/2003
• Status: Abandoned Application

• Current Assignee: Sensys Medical, Inc. (Sensys Medical Limited)
• Original Assignee: Sensys Medical, Inc. (Sensys Medical Limited)
• Inventors: Acosta, George M., Brown, Sedar, Elliott, Barry C., Henderson, James R., Monfre, Stephen L., Hazen, Kevin H., Blank, Thomas B., Abul-Haj, Roxanne E., Richie, Benjamin L. Jr., Hope, Josh
• Application Number:
  US11/031,103
• Publication Number:
  US 20050187439A1
• Time in Patent Office: Days
• US Class Current: 600/310
• 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: G01N 21/359 using near infrared light

Abstract

Sampling is controlled to enhance analyte concentration estimation derived from noninvasive sampling. Means of assuring that the same tissue sample volume is repeatably sampled are presented, thus minimizing sampling errors due to mechanical tissue distortion, specular reflectance, and probe placement. In a first embodiment of the invention, sampling is controlled using automated delivery of a coupling fluid to a region between a tip of a sample probe and a tissue measurement site in a manner requiring minimal user interaction. In a second embodiment of the invention, sampling is controlled by controlling temperature variations, preferably with a coupling fluid, at a region about the tip of a sample probe and a sample site. In a third embodiment, sampling is procedurally controlled via timing and location of coupling fluid delivery to a sample site.

Claims

1. An apparatus for delivery of coupling fluid to a sample site in connection with a noninvasive analyte concentration analyzer, comprising:

a reservoir coupled to said analyzer for containing said coupling fluid;

delivery means for periodically coupling said reservoir to said sample site; and

means for driving said coupling fluid from said reservoir to said sample site.

2. The apparatus of claim 1, wherein said reservoir comprises any of:

a replaceable cartridge;

a multiuse container;

a single use packet; and

a syringe.

3. The apparatus of claim 1, wherein said analyzer comprises:

a sample module in a first housing, said sample module having a tip;

a base module in a second housing separated from said first housing; and

a communication bundle having a first end connected to said sample module and a second end connected to said base module.

4. The apparatus of claim 3, wherein said reservoir resides in any of:

said analyzer;

said base module;

said sample module; and

a third housing separated from said analyzer.

5. The apparatus of claim 1, wherein said delivery means comprises any of:

tubing having an inner side;

flexible tubing;

a lumen;

routing; and

a channel.

6. The apparatus of claim 5, wherein said inner side of said tubing comprises a hydrophilic surface.

7. The apparatus of claim 3, wherein said delivery means routes said coupling fluid to within one inch of said tip of said sample module.

8. The apparatus of claim 1, wherein said analyzer further comprises:

means for temperature control.

9. The apparatus of claim 3, wherein said means for temperature control modify temperature of any of:

said sample site;

said tip of said sample analyzer; and

said coupling fluid.

10. The apparatus of claim 9, wherein said means for temperature control adjust temperature any of said sample site surface, said tip of said analyzer, and said coupling fluid toward a target temperature.

11. The apparatus of claim 10, wherein said target temperature comprises any of about 88, 90, 92, 94, 96, and 98 degrees Fahrenheit.

12. The apparatus of claim 1, said analyzer further comprising:

fluid detection means coupled to said delivery means.

13. The apparatus of claim 12, wherein said fluid detection means comprises:

a light source and a detector optically coupled to said light source via said delivery means for detection of intensity changes.

14. The apparatus of claim 1, said analyzer further comprising:

a processing unit integrated into said analyzer.

15. The apparatus of claim 1, wherein said analyzer further comprises:

optical means for alignment of said analyzer to said sample site.

16. The apparatus of claim 15, said optical means comprising:

a detector for outputting a signal, wherein said detector comprises any of;

a pressure sensor; and

a photon detector.

17. The apparatus of claim 15, said optical means comprising:

a z-axis movable sample probe.

18. The apparatus of claim 15, wherein said optical means comprises:

a closed-loop system.

19. The apparatus of claim 1, wherein said means for driving comprises any of:

gravity feed;

capillary action;

a peristaltic pump;

a motor;

a piston;

a drive;

a solenoid;

a gear;

potential energy; and

a magnetic drive.

20. The apparatus of claim 19, wherein said potential energy comprises any of:

a spring; and

compressed gas.

21. The apparatus of claim 1, wherein said means for driving comprises any of:

an automated delivery system; and

a closed-loop system.

22. The apparatus of claim 1, wherein said means for driving deliver less than twenty microliters of coupling fluid to said sample site with each use.

23. A method of sampling a tissue site, comprising the steps of:

providing a near-infrared noninvasive analyte concentration analyzer having a sample probe, said sample probe having an end;

sampling said tissue site with said analyzer, thereby generating signal;

estimating proximity of said sample probe end relative to said tissue site using said signal; and

dispensing coupling fluid about said tissue site based upon said proximity, wherein said coupling fluid is dispensed through said sample probe.

24. The method of claim 23, wherein said signal comprises any of:

an optical reading;

a near-infrared optical response;

a pressure reading; and

an interference fringe.

25. The method of claim 23, wherein said step of dispensing proceeds after said step of estimating proximity establishes proximate contact of said sample probe end with said tissue site.

26. The method of claim 23, further comprising moving said sample probe relative to said tissue site.

27. The method of claim 26, wherein said step of dispensing proceeds after said step of moving said sample probe retracts said tip of said sample probe from contact with said tissue site.

28. The method of claim 23, wherein said step of dispensing recurs after said step of moving said sample probe.

29. The method of claim 26, wherein said step of dispensing occurs during said step of moving said sample probe.

30. The method of claim 26, wherein said step of moving comprises at least z-axis movement of said sample probe tip.

31. The method of claim 23, further comprising a step of preheating an element.

32. The method of claim 31, wherein said element comprises any of:

a surface of said sample site, wherein said surface proximately contacts said end of said sample probe during said step of sampling;

said coupling fluid; and

said sample probe tip.

33. The method of claim 31, wherein said step of preheating comprises preheating:

said coupling fluid; and

said sample probe tip.

34. The method of claim 32, wherein said step of preheating comprises preheating to a target temperature, wherein said target temperature comprises any of about 88, 90, 92, 94, 96, and 98 degrees Fahrenheit.

35. The method of claim 23, wherein said step of sampling comprises collecting a noninvasive spectrum of said sample site;

and further comprising a step of;

estimating analyte concentration from said noninvasive spectrum, wherein said analyte comprises any of;

glucose;

water;

fat; and

urea.

36. The method of claim 23, wherein said steps of estimating proximity and dispensing coupling fluid comprise any of:

an automated delivery system; and

a closed-loop system.

37. An apparatus for noninvasive estimation of an analyte property of a human with an analyzer, wherein a portion of said analyzer comprises a sample module having an end, said estimation performed via a sample site of said human, comprising:

a reservoir either connected to or integrated into said analyzer; and

means for automated delivery of coupling fluid between said reservoir and said sample site;

wherein at least a portion of said means for automated delivery is integrated with said analyzer.

38. The apparatus of claim 37, wherein said reservoir comprises either a replaceable cartridge or a multiuse container.

39. The apparatus of claim 37, wherein said means for automated delivery comprise either a manual control open-loop system or a closed-loop system.

40. The apparatus of claim 39, wherein said closed-loop system comprises any of:

signal input;

algorithm control;

z-axis movement control of said sample module; and

driving means.

41. The apparatus of claim 40, wherein said signal comprises any of:

an optical reading;

a near-infrared optical response;

a pressure reading;

temperature control; and

an interference fringe.

42. The apparatus of claim 40, wherein said signal comprises at least two of:

an optical reading;

a near-infrared optical response;

a pressure reading;

temperature control; and

an interference fringe.

43. The apparatus of claim 40, wherein said driving means comprises any of:

gravity feed;

capillary action;

a peristaltic pump;

a motor;

a piston;

a drive;

a solenoid;

a gear;

potential energy; and

a magnetic drive.

44. The apparatus of claim 42, wherein said temperature control comprises preheating any of:

a surface of said sample site, wherein said surface proximately contacts said end of said sample probe during use;

said coupling fluid; and

said end of said sample probe.

45. The apparatus of claim 44, wherein said preheating comprises heating to about any of about 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, and 98 degrees Fahrenheit.

46. The apparatus of claim 44, wherein said property comprises concentration and said analyte comprises any of:

glucose;

water;

fat; and

urea.

47. The apparatus of claim 37, wherein said means for automated delivery routes within one inch of said end of said sample module and wherein sampling error is minimized, eliminated, reduced, or compensated.

48. The apparatus of claim 37, wherein said means for automated delivery deliver less than thirty microliters of coupling fluid to said sample site with each use.

49. A method for noninvasively sampling a tissue site having a surface, comprising the steps of:

providing a noninvasive analyte property analyzer having a sample probe, said sample probe having a tip;

setting a target temperature;

adjusting toward said target temperature at least two of;

said sample probe tip temperature;

said surface of said tissue site temperature; and

a coupling fluid temperature prior to application of said coupling fluid between said sample probe tip and said tissue site;

moving said sample probe tip into close proximity with said surface of said tissue site;

collecting noninvasive near-infrared signal of said tissue site with said analyzer; and

estimating said analyte property using said signal.

50. The method of claim 49, wherein said target temperature comprises any of about 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, and 98 degrees Fahrenheit.

51. The method of claim 50 wherein said analyte comprises any of:

water;

protein;

fat;

urea; and

glucose.

52. An apparatus for noninvasively estimating a sample property with a near-infrared noninvasive analyte property analyzer having a sample probe, said sample probe having a tip through a tissue site having a surface, comprising:

means for adjusting toward a target temperature at least two of;

said sample probe tip temperature;

said surface of said tissue site temperature; and

a coupling fluid temperature prior to application of said coupling fluid between said sample probe tip and said tissue site;

means for moving said sample probe tip into close proximity with said surface of said tissue site, wherein said means for moving are integrated with said analyzer; and

means for noninvasive near-infrared signal collection representative of said tissue site with said analyzer.