Optical sampling interface system for in-vivo measurement of tissue

• US 20050203359A1
• Filed: 12/08/2004
• Published: 09/15/2005
• Est. Priority Date: 05/02/2000
• Status: Active Grant

• Current Assignee: Willow Laboratories Incorporated
• Original Assignee: Sensys Medical, Inc. (Sensys Medical Limited)
• Inventors: Ruchti, Timothy L., Monfre, Stephen L., Hazen, Kevin H., Blank, Thomas B., Abul-Haj, Roxanne E., Lorenz, Alexander D., Berry, Donovan D., Acosta, George, Mattu, Mutua, Makarewicz, Marcy
• Granted Patent: US 7,606,608 B2
• Time in Patent Office: Days
• US Class Current: 600/344
• 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 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: G01N 21/359 using near infrared light

Abstract

An optical sampling interface system is disclosed that minimizes and compensates for errors that result from sampling variations and measurement site state fluctuations. Embodiments of the invention use a guide that does at least one of, induce the formation of a tissue meniscus, minimize interference due to surface irregularities, control variation in the volume of tissue sampled, use a two-part guide system, use a guide that controls rotation of a sample probe and allows z-axis movement of the probe, use a separate base module and sample module in conjunction with a guide, and use a guide that controls rotation. Optional components include an occlusive element and a coupling fluid.

Claims

1. A guide for positioning a sample probe at a targeted measurement site, wherein said sample probe comprises a single sample probe tip, said guide comprising:

a first alignment piece having a contact surface, at least a portion of said contact surface being in contact with a surface proximate said measurement site during use;

said first alignment piece comprising means for rotation alignment of said sample probe with respect to said alignment piece;

wherein rotation of said sample probe is not required to position said sample probe at said measurement site.

2. The guide of claim 1, wherein said sample probe tip comprises an optical probe tip.

3. The guide of claim 2, further comprising means for registering any of x-, y-, and z-location of said sample probe with respect to said alignment piece.

4. The guide of claim 3, wherein said means for registering comprises any of:

an indentation;

a ball bearing;

a kinematic mount;

a hinge;

a slide;

an extrusion;

an indentation; and

a mechanical stop.

5. The guide of claim 3, wherein said means for registering comprises an aperture, defined by said alignment piece, for receiving said optical probe, wherein at least a portion of an area, defined by said aperture comprises said measurement site.

6. The guide of claim 5, further comprising means for occluding of said measurement site.

7. The guide of claim 1, wherein said guide comprises at least one flexible member.

8. The guide of claim 7, wherein said flexible member comprises a living hinge.

9. The guide of claim 1, wherein said surface proximate said measurement site comprises any of:

an adhesive layer;

an intermediate layer between said contact surface of said first alignment piece and said measurement site; and

an outer skin layer of said measurement site.

10. The guide of claim 1, further comprising:

a second alignment piece not directly attached to said first alignment piece, said second alignment piece being in contact with said surface proximate said measurement site during use;

11. The guide of claim 10, wherein said first alignment piece and said second alignment piece jointly control rotation alignment of said sample probe.

12. The guide of claim 10, wherein said first alignment piece comprises:

means for registering x-, y-, and z-location of said sample probe with respect to said measurement site.

13. The guide of claim 12, wherein said second alignment piece comprises:

means for registering y-location and z-location of said sample probe with respect to said measurement site.

14. The guide of claim 1, wherein said means for rotational alignment comprises magnetic registration means along any of x-, y-, and z-axes.

15. The guide of claim 1, further comprising:

a first layer being between said alignment piece and said measurement site, said first layer comprising a top surface and a bottom surface, wherein at least a portion of said top surface is attached to said contact surface of said alignment piece, and wherein said first layer comprises any of;

an adhesive;

a flexible material;

acetate;

polytetrafluoroethylene; and

a peel-off layer.

16. The guide of claim 15, wherein said bottom surface is positioned at said surface proximate said measurement site during use.

17. The guide of claim 15, further comprising;

a second layer having an upper surface and a lower surface, wherein at least a portion of said upper surface of said second layer is attached to said bottom surface of said first layer.

18. The guide of claim 17, wherein at least a portion of said lower surface of said second layer is positioned at said measurement site.

19. The guide of claim 17, wherein said second layer comprises any of:

an adhesive;

a flexible material;

a deformable material;

a substrate; and

a peel-off layer.

20. The guide of claim 1, wherein said measurement site is outside of an area defined by perimeter of said alignment piece.

21. The guide of claim 1, wherein said measurement site comprises:

a tissue measurement site, wherein surface tissue at said measurement site comprises either of skin, and skin surface comprising stratum corneum

22. The guide of claim 1, further comprising:

means for stabilizing skin surface temperature.

23. The guide of claim 22, wherein said means for stabilizing skin surface temperature comprise at least one of a plug and a heater.

24. An optical probe sampling interface system for coupling an optic probe to a sample site, comprising:

a first alignment piece having a contact surface, at least a portion of said contact surface positioned in contact with a surface proximate said sample site during use; and

a second alignment piece having a tissue side surface, at least a portion of said tissue side surface positioned in contact with said surface proximate said sample site during use;

wherein said first alignment piece is separated from said second alignment piece; and

wherein said first alignment piece and said second alignment piece cooperate to register at least two of x-position, y-position, z-position, and rotation of said sample probe relative to said sample site.

25. The system of claim 24, wherein said sample site comprises a region outside of two perimeters defined by said contact surface of said first alignment piece and said tissue side surface of said second alignment piece.

26. The system of claim 24, wherein said first alignment piece comprises means for magnetic registration of said optic probe to any of said x-, y- and z-positions.

27. The system of claim 24, wherein said second alignment piece comprises means for magnetic registration of said optic probe to any of said y-position and said z-position.

28. The system of claim 24, wherein magnetic force facilitates alignment of said optic probe to said sample site.

29. The system of claim 24, wherein either of said alignment pieces comprise a flexible portion.

30. The system of claim 29, wherein said flexible portion comprises a living hinge.

31. The system of claim 24, further comprising means for occlusing of said sample site.

32. The system of claim 24, further comprising:

means for correcting measurement bias resulting from at least one of variation in sampled volume and variation in measurement condition.

33. The system of claim 24, wherein during collection of a noninvasive spectrum, said optic probe has z-axis freedom of motion.

34. The system of claim 24, further comprising:

a first layer having a top surface and a bottom surface, wherein at least a portion of said top surface is attached to said contact surface of said first alignment piece, and wherein at least a portion of said top surface is attached to said tissue side surface of said second alignment piece.

35. The system of claim 34, wherein said first layer comprises any of:

an adhesive;

a flexible material;

acetate;

polytetrafluoroethylene; and

a peel off layer.

36. The system of claim 35, further comprising:

a second layer having an upper surface and a lower surface, wherein at least a portion of said upper surface is attached to said bottom surface of said first layer.

37. The system of claim 36, wherein at least a portion of said lower surface is attached to said sample site.

38. The system of claim 37, wherein said second layer comprises any of:

an adhesive;

a flexible material;

a deformable material;

a substrate; and

a peel off layer.

41. The jig of claim 34, wherein said alignment piece comprises:

means for registration of said sample probe to x-position and y-position.

42. The jig of claim 34, wherein said alignment piece comprises at least one flexible portion.

39. A jig for repeatably positioning a z-axis movable sample probe comprising a single probe tip at a targeted measurement site, said jig comprising:

an alignment piece having a contact surface, at least a portion of said contact surface being in contact with a surface proximate said measurement site during use; and

means for rotational alignment of said sample probe with respect to said alignment piece;

wherein said jig allows during use z-axis freedom of movement of said sample probe relative to said measurement site.

40. The jig of claim 39, wherein said measurement site comprises a region that is one of within, partially within, and outside of the perimeter defined by said contact surface of said alignment piece.

43. The jig of claim 39, further comprising:

a first layer having a top surface and a bottom surface, wherein at least a portion of said top surface is attached to said contact surface of said alignment piece, wherein said first layer comprises any of;

an adhesive;

a flexible material;

acetate;

polytetrafluoroethylene; and

a peel off layer.

44. The jig of claim 43, further comprising:

a second layer having an upper surface and a lower surface, wherein at least a portion of said upper surface attaches to said bottom surface of said first layer.

45. The jig of claim 44, wherein at least a portion of said lower surface of said second layer replaceably attaches to said measurement site.

46. The jig of claim 44, wherein said second layer comprises any of:

an adhesive;

a flexible material;

a deformable material;

a substrate; and

a peel off layer.

47. The jig of claim 39, further comprising:

means for stabilizing surface temperature.

48. An apparatus for registering a sample probe to a tissue site, comprising:

a first alignment piece comprising;

a sample surface wherein at least a portion of said sample surface contacts a surface proximate said tissue site during use; and

an alignment section adapted to receive said sample probe;

wherein at least a portion of said alignment piece comprises a flexible material.

49. The apparatus of claim 48, wherein said alignment piece registers said sample probe relative to said tissue site for at least two of x-position, y-position, z-position, and rotation.

50. The apparatus of claim 49, wherein said alignment piece registers said sample probe relative to said tissue site for at least three of x-position, y-position, z-position, and rotation.

51. The apparatus of claim 48, wherein a portion of said alignment piece comprises a magnet providing a force aiding in coupling of said guide to said sample probe.

52. The apparatus of claim 48, further comprising:

a second alignment piece having a tissue side surface, at least a portion of said tissue side surface being in contact with said surface proximate said sample site during use;

wherein said first alignment piece is separated from said second alignment piece.

53. The apparatus of claim 52, wherein said first alignment piece and said second alignment piece cooperate to register at least two of x-position, y-position, z-position, and rotation of said sample probe relative to said tissue site.

54. The apparatus of claim 48, further comprising:

a first layer having a top surface and a bottom surface, wherein at least a portion of said top surface is attached to said contact surface of said alignment piece.

55. The apparatus of claim 54, wherein said first layer comprises any of:

an adhesive;

a flexible material;

acetate;

polytetrafluoroethylene; and

a peel off layer.

56. The apparatus of claim 52, further comprising:

a second layer having an upper surface and a lower surface, wherein at least a portion of said upper surface is attached to said bottom surface of said first layer.

57. The apparatus of claim 56, wherein at least a portion of said bottom surface replaceably attaches to said tissue site.

58. The apparatus of claim 56, wherein said second layer comprises any of:

an adhesive;

a flexible material;

a deformable material;

a substrate; and

a peel off layer.

59. An optic probe guide for registering a sample probe to a tissue site, comprising:

a first alignment piece having a sample surface, at least a portion of said sample surface being in contact with a surface proximate said tissue site during use; and

means for registration of said sample probe to said tissue site for at least three of x-position, y-position, z-position, and rotation of said sample probe relative to said tissue site;

wherein at least a portion of said alignment piece comprises a flexible material, whereby said flexible material deforms to distribute load of said sample probe about said tissue site.

60. An apparatus for reproducibly registering a tip of an optical sample probe to a sample site, comprising:

a guide comprising a sample side;

means for alignment of said sample probe tip to said sample site;

wherein said guide comprises;

a magnet providing at pulling force for drawing said sample tip to said guide.

61. A noninvasive analyzer for tissue sample property estimation comprising:

a base module in a first container;

a communication bundle with a first end and a second end, wherein said first end connects to said base module;

a sample module in a second container separated from said first container, wherein said second end of said communication bundle connects to said sample module;

wherein said sample module comprises a sample probe tip; and

guide means replaceably attached to said sample module probe tip, wherein said guide means register said tissue sample to said sample module probe tip.

62. An apparatus for noninvasive estimation of a sample constituent property from a noninvasive spectrum of a tissue sample, comprising:

an analyzer comprising;

a base module;

a sample module, wherein signals are communicated between said sample module and said base module;

a model residing in said analyzer; and

a guide for registering said sample module to said tissue sample during use;

wherein said model is applied to said noninvasive spectrum for estimation of said sample constituent property.

63. The apparatus of claim 62, wherein said sample constituent property comprises glucose concentration.

64. The apparatus of claim 63, said signals comprising any of optical and electrical signals.

65. The apparatus of claim 63, wherein at least part of said guide comprises a flexible material.

66. The apparatus of claim 63, wherein at least part of said guide comprises one or more magnets.

67. An optical probe placement guide for positioning a non-symmetrical optical probe to a targeted measurement site, comprising:

an alignment piece having a contact surface, at least a portion of said contact surface being in contact with a surface proximate said measurement site during use; and

means for rotational alignment of said optical probe with respect to said alignment piece;

wherein said optical probe is non-symmetrical

68. The guide of claim 67, wherein said optical probe comprises both incident optics and collection optics.

69. The guide of claim 67, further comprising:

means for registering at least one of x-, y-, and z-location of said optical probe with respect to said alignment piece.