Method and apparatus for minimizing spectral interference due to within and between sample variations during in-situ spectral sampling of tissue

• US 6,839,584 B2
• Filed: 09/17/2001
• Issued: 01/04/2005
• Est. Priority Date: 05/02/2000
• Status: Expired due to Fees

• Current Assignee: GLT Acquisition Corporation
• Original Assignee: Instrumentation Metrics Inc.
• Inventors: Hay, William, Stippick, Timothy, Handy, Edward, Richie, Benjamin, Blank, Thomas B., Acosta, George, Mattu, Mutua, Makarewicz, Marcy
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): KREMER, MATTHEW J
• Application Number:
  US09/954,856
• Publication Number:
  US 20020099278A1
• Time in Patent Office: 1,205 Days
• Field of Search: 600322-326, 600334-335, 600/344, 600/340, 600/336
• US Class Current: 600/344
• CPC Class Codes: A61B 2562/146 for optical coupling
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/6824 Arm or wrist

Abstract

An apparatus and method for reproducibly interfacing a living tissue sample to the measurement probe of a spectrometer instrument in-situ minimizes spectral interference related to sampling variations. A minimal contact subject interface includes supports replaceably mounted on a base. An optical coupling means, such as a fiber optic probe, contacts the measurement site through a probe aperture in the base. During use, a subject rests an extremity on the support elements, so that the extremity is reproducibly positioned and supported in relation to the optical coupling means. The supports have a small contact area, minimizing contact with the skin at the measurement site. The interface module is adjustable to fit any subject.

By reproducibly positioning and supporting the body appendage using minimal contact supports, spectral interference due to variations in placement, applied pressure, and temperature transients secondary to contact with the interface module are greatly minimized.

Claims

1. An interlace module for limiting sampling variation during in-situ spectral sampling at a tissue measurement site on an arm of a live subject, comprising:

a base having a top surface, a bottom surface and opposing ends, said base defining an aperture that communicates from said bottom surface to said top surface;

an elbow support, said elbow support replaceably attached to said top surface at a first of said opposing ends;

a wrist support said wrist support replaceably attached to said top surface toward a second of said opposing ends; and

a hand support, said hand support slideably attached to said base at said second of said opposing ends and protruding from said opposing end;

said interface module configured to receive said arm so that said arm is supported in a comfortable position and reproducibly positioned in relation to a fiber optic probe;

wherein said supports limit contact of said arm with said interface module to distinct registration points; and

wherein said interface module is customizable to individual subjects.

2. The interface module of claim 1, wherein said sampling variation comprises either of:

within sample interference; and

interference between samples.

3. The interface module of claim 1, wherein said sampling variation results from any of:

variation in placement of said arm in relation to said optical coupling means between samples;

variation in pressure applied by said optical coupling means to said tissue measurement site within or between samples; and

surface temperature transients, at said tissue measurement site, caused by contact of said arm with said interface module within a sample.

4. The interface module of claim 1, wherein said interface module is positioned during use such that said probe is received by said aperture at said bottom surface and protrudes through said top surface to make contact with said tissue measurement site when said arm is seated in said interface module.

5. The interface module of claim 1, wherein said elbow support includes a depression that approximately mirrors the shape of an elbow, wherein said elbow is received by said depression when said arm is seated in said interface module, so that said elbow is reproducibly positioned and supported, said elbow support being provided in a plurality of shapes and sizes, according to diameter of said elbow.

6. The interface module of claim 1, wherein said elbow support further comprises one or more shims for adjusting elbow height, said shim being placed beneath said elbow support, and wherein said shim is provided in a plurality of thicknesses.

7. The interface module of claim 1, wherein said wrist support provides a surface upon which a wrist is rested during use, so that said wrist is reproducibly positioned and supported, and wherein said wrist support is provided in a plurality of heights and contours.

8. The interface module of claim 1, wherein said hand support provides a surface upon which a hand is rested during use, so that said hand is reproducibly positioned and supported;

and

wherein said hand support is slideably adjustable so that a variety of arm lengths may be accommodated.

9. The interlace module of claim 1, wherein said supports are custom-fabricated for a specific subject.

10. The interface module of claim 1, said interface being fabricated from one or both of:

one or more thermoplastic polymers; and

one or more elastomeric polymers.

11. An interface module for limiting sampling variation during in-situ spectral sampling at a tissue measurement site, comprising:

a base having two opposing surfaces and two opposing ends;

a plurality of support elements mounted on said base, wherein said support elements are adapted to receive a member bearing said tissue measurement site so that said tissue measurement site is reproducibly positioned and supported in relation to an optical coupling means, wherein said supports limit contact of said member with said interface module to distinct registration points; and

wherein said interface module is adjustable to individual subjects.

12. The interface module of claim 11, wherein said sampling variation comprises either of:

within sample interference; and

interference between samples.

13. The interface module of claim 11, wherein said sampling variation results from any of:

variation in placement of said member in relation to said optical coupling means between samples;

variation in pressure applied by said optical coupling means to said tissue measurement site within or between samples; and

surface temperature transients at said tissue measurement site, caused by contact of said member with said interface module within a sample.

14. The interface module of claim 11, wherein said base defines an aperture communicating from a first of said surfaces to a second of said surfaces.

15. The interface module of claim 14, said optical coupling means comprising a fiber optic probe, wherein said interface module is positioned during use such that said probe is received by said aperture at said first surf and protrudes through said surface to make contact with said tissue measurement site when said member is seated in said interface module.

16. The interface module of claim 15, wherein said member comprises an arm on a human subject.

17. The interface module of claim 16, wherein said support elements include one or more of:

an elbow support;

a wrist support; and

a hand support.

18. The interface module of claim 17, wherein said elbow support is replaceably attached to said top surface at a first of said opposing ends.

19. The interface module of claim 17, wherein said elbow support includes a depression that approximately mirrors the shape of an elbow, wherein said elbow is received by said depression when said arm is seated in said interface module, so that said elbow is reproducibly positioned and supported.

20. The interface module of claim 19, wherein said elbow support further comprises means for adjusting elbow height.

21. The interface module of claim 20, wherein said means for adjusting elbow height comprises at least one shim, wherein said shim is placed beneath said elbow support, and wherein said shim is provided in a plurality of thicknesses.

22. The interface module of claim 17, wherein said elbow support is provided in a plurality of shapes and sizes, according to diameter of said elbow.

23. The interface module of claim 17, wherein said wrist support is replaceably attached at said top surface of said base toward a second of said two opposing ends.

24. The interface module of claim 17, wherein said wrist support provides a surface upon which a wrist as rested during use, so that said wrist is reproducibly positioned and supported.

25. The interface module of claim 17, wherein said wrist support is provided in a plurality of heights and contours.

26. The interface module of claim 17, wherein said hand support is slideably attached to said base at said second of said opposing ends and protruding from said second end, wherein said hand support is slideably adjustable so that a variety of arm lengths may be accommodated.

27. The interface module of claim 17, wherein said hand support provides a surface upon which a hand is rested during use, so that said hand is reproducibly positioned and supported.

28. The interface module of claim 17, wherein said supports are custom-fabricated to a specific subject.

29. The interface module of claim 11, said interface being fabricated from one or both of:

one or more thermoplastic polymers; and

one or more elastomeric polymers.

30. A method of limiting sampling variation during in-situ spectral sampling at a tissue measurement site comprising the steps of:

minimizing variation in placement of a tissue measurement site in relation to an optical coupling means by means of one or more support elements that receive a member bearing said tissue measurement site, so that substantially the same region is sampled at each measurement;

minimizing variation in pressure applied by art optical coupling means to said tissue measurement site so that substantially the same volume of tissue is displaced at each measurement; and

minimizing surface temperature transients at said tissue measurement site by minimizing contact of said member with said interface module so that temperature remains substantially constant for each measurement;

wherein signal-to-noise ratio is optimized to facilitate signal detection.

31. The method of claim 30, wherein said step of minimizing variations in placement of said issue measurement site comprises reproducibly positioning a member bearing said tissue measurement site in relation to said optical coupling means.

32. The method of claim 31, wherein said step of minimizing variations in pressure applied by said optical coupling means to said tissue measurement site comprises reproducibly supporting said member in relation to said optical coupling means.

33. The method of claim 32, further comprising the step of providing a minimal contact subject interface module, said subject interface module comprising:

a base having two opposing surfaces and two opposing ends;

a plurality of support elements mounted on said base, wherein said support elements are adapted to receive said member beating said tissue measurement site so that said issue measurement site is reproducibly positioned and supported in relation to said optical coupling means; and

wherein said supports minimize contact of said tissue measurement site with said interface module.

34. The method of claim 33, wherein said base defines an aperture communicating from a first of said surfaces to a second of said surface.

35. The method of claim 34, said optical coupling means comprising a fiber optic probe wherein said interface module is positioned during use such that said probe is received by said aperture at said first surface and protrudes through said second surface to make contact with said tissue measurement site when said member is seated in said interface module.

36. The method of claim 35, wherein said member comprises an arm on a human subject.

37. The method of claim 36, wherein said support elements include one or more of:

an elbow support;

a wrist support; and

a hand support.

38. The method of claim 37, wherein said elbow support is replaceably attached to said top surface at a first of said opposing ends.

39. The method of claim 37, wherein said elbow support includes a depression that approximately mirrors the shape of an elbow, wherein said elbow is received by said depression when said arm is seated in said interface module, so that said elbow is reproducibly positioned and supported.

40. The method of claim 37, wherein said elbow support is provided in a plurality of shapes and sizes, according to diameter of said elbow.

41. The method of claim 40, wherein said elbow support further comprises means for adjusting elbow height.

42. The method of claim 41, wherein said means for adjusting elbow height comprises at least one shim, wherein said shim is placed beneath said elbow support, and wherein said shim is provided in a plurality of thicknesses.

43. The method of claim 37, wherein said wrist support provides a surface upon which a wrist is rested during use, so that said wrist is reproducibly positioned and supported.

44. The method of claim 37, wherein said wrist support as provided in a plurality of heights and contours.

45. The method of claim 37, wherein said hand support is slideably attached to said base at said second of said opposing ends and protruding from said second end, wherein said hand support is slideably adjustable so that a variety of arm lengths may be accommodated.

46. The method of claim 37, wherein said hand support provides a surface upon which a hand is rested during use, so that said hand is reproducibly positioned and supported.

47. The method of claim 37, wherein said supports am custom-fabricated for a specific subject.

48. An interface module for limiting sampling variation during in-situ spectral sampling at a tissue measurement site, comprising:

one or more support elements, wherein said one or more support elements are adapted to receive a member bearing said tissue measurement site so that said tissue measurement site is reproducibly positioned and supported in relation to an optical coupling means, wherein said one or more support elements limit contract of said member with said interface module to distinct registration points.

49. The interface module of claim 48, further comprising a base, wherein said one or more support elements are mounted on said base.

50. A method of limiting sampling variation during in-situ spectral sampling at a tissue measurement site comprising the steps of:

minimizing variation in placement of a tissue measurement site in relation to an optical coupling means, so that substantially the same region is sampled at each measurement; and

minimizing variation in pressure applied by an optical coupling means to said tissue measurement site by liming contact of a member bearing said tissue measurement site to distinct registration points, so that substantially the same volume of tissue is displaced.

51. The method of claim 50, further comprising a step of:

minimizing surface temperature transients at said tissue measurement site so that temperature remains substantially constant for each measurement.

52. The method of claim 50, wherein signal-to-noise ratio is optimized to facilitate net analyte signal detection.

53. A method of limiting sampling variation during in-situ spectral sampling at a tissue measurement the comprising the steps of:

minimizing variation in placement of a tissue measurement site in relation to as optical coupling means by means of one or more support elements that receive a member bearing said tissue measurement site, so that substantially the same region is sampled at each measurement; and

minimizing surface temperature transients at said tissue measurement site, by limiting contact of a member bearing said tissue measurement site with a subject interface module, so that temperature remains substantially constant for each measurement.

54. The method of claim 53, further comprising a step of:

minimizing variation in pressure applied by an optical coupling means to said tissue measurement site so that substantially the same volume of tissue is displaced.

55. The method of claim 53, wherein signal-to-noise ratio is optimized to facilitate net analyte signal detection.