Noninvasive analyzer sample probe interface method and apparatus

• US 20060211931A1
• Filed: 02/21/2006
• Published: 09/21/2006
• Est. Priority Date: 05/02/2000
• Status: Abandoned Application

• Current Assignee: Sensys Medical, Inc. (Sensys Medical Limited)
• Original Assignee: Sensys Medical, Inc. (Sensys Medical Limited)
• Inventors: Henderson, James R., Hazen, Kevin H., Blank, Thomas B., Abul-Haj, Roxanne, Mattu, Mutua
• Application Number:
  US11/359,700
• Publication Number:
  US 20060211931A1
• Time in Patent Office: Days
• US Class Current: 600/344
• CPC Class Codes: A61B 2562/187 Strain relief means
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6841 by using templates
• CPC Class Codes: A61B 5/6842 by marking the skin

Abstract

The invention provides an adaptive mount for use in coupling a noninvasive analyte property analyzer to a living tissue sample site. The adaptive mount increases precision and accuracy of sampling by relieving stress and strain on a sample prior to and/or during sampling, which results in noninvasive analyte property estimations with corresponding performance enhancement.

Claims

1. An adaptive mount for coupling a sample probe to a sample site of a tissue, comprising:

a first alignment piece; and

a second alignment piece;

wherein both said first alignment piece and said second alignment piece replaceably abut said tissue,

wherein said first alignment piece and said second alignment piece cooperate to position said sample probe relative to said sample site during use; and

wherein said adaptive mount adapts said position of said sample probe relative to said tissue as either distance between, or orientation of, said first alignment piece and said second alignment piece change due to state change of said tissue.

2. The mount of claim 1, wherein said position floats in terms of at least one of an x-axis and a y-axis relative to a fixed x,y-sample site position;

and wherein said x-axis is along the length of a body part and said y-axis is across said body part.

3. The mount of claim 1, further comprising:

a first registration piece connected to said first alignment piece; and

a second registration piece connected to said second alignment piece,

wherein said first registration piece and said second registration piece cooperatively orientate said sample probe relative to said tissue in at least two of;

a x-axis position;

a y-axis position; and

a z-axis position.

4. The mount of claim 3, wherein either said first registration piece or said second registration piece comprise any of:

a ball bearing;

a kinematic mount;

a hinge;

a slide;

an extrusion from said first and second alignment piece, respectively;

an indentation into said first and second alignment piece, respectively; and

a mechanical stop.

5. An apparatus for noninvasively measuring an analyte property at a sample site of tissue, comprising:

a base module;

a sample module coupled to said base module, said sample module having a tip; and

an adaptive mount replaceably coupled to said sample module,

wherein said adaptive mount positions with freedom of movement along at least one of an x-axis and a y-axis said sample probe tip relative to a sample site of said tissue as said tissue changes state in terms of any of;

elongation;

expansion;

contraction; and

twist orientation,

wherein said x-axis is along the length of a body part and said y-axis is across said body part.

6. The apparatus of claim 5, further comprising:

a controller controlling, via an actuator, movement of said sample probe tip along an axis about normal to a surface defined by said x-axis and y-axis.

7. The apparatus of claim 6, where said controller operates using signal from a sensor, wherein said sensor comprises any of:

a pressure sensor;

an optical sensor;

a distance sensor;

a position sensor;

a tilt sensor;

a thermal sensor; and

a contact sensor.

8. The apparatus of claim 7, wherein said controller is used in positioning said sample probe tip within one millimeter of said sample site.

9. The apparatus of claim 8, wherein said controller controls tilt of said sample probe relative to said tissue.

10. The apparatus of claim 5, wherein said sample module and said base module are communicatively connected using any of:

wireless communication; and

a communication bund1e.

11. The apparatus of claim 5, wherein said base module comprises a photo-diode array detector and wherein said sample module comprises a source.

12. The apparatus of claim 5, wherein said sample module and said base module are combined into a handheld analyzer.

13. A method for noninvasive analysis of a tissue sample glucose concentration, comprising the step of:

moving a sample probe tip into proximate contact with a tissue sample site, with freedom of movement along at least one of an x-axis and a y-axis relative to said sample site as tissue at said sample site changes state in terms of any of;

elongation;

expansion;

contraction; and

twist orientation;

wherein said x-axis is along the length of a body part and said y- axis is across said body part;

wherein said means for moving are operatively coupled to an analyzer;

acquiring with said analyzer a noninvasive near-infrared spectrum of said tissue sample; and

determining glucose concentration representative of said tissue sample by applying a multivariate analysis to said noninvasive spectrum.

14. An apparatus for to coupling a sample probe to a sample site of tissue, comprising:

a mount in proximate contact with said tissue during use;

wherein said mount is used in conjunction with a noninvasive analyzer having a sample probe;

and

wherein during use said mount adapts position of said sample probe relative to said tissue as said tissue changes state in terms of any of;

response to a stress;

an elongation;

a contraction; and

a twist.

15. The apparatus of claim 14, wherein said position of said sample probe comprises an x,y-location of said sample probe;

and wherein said x-axis is along the length of a body part and said y-axis is across said body part.

16. An adaptive mount used to couple a sample probe to a sample site of a tissue, 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 tissue during use; and

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 tissue during use;

wherein said first alignment piece and said second alignment piece move with said tissue as said tissue changes state in terms of any of expansion, contraction, and twist;

wherein said first alignment piece and said second alignment piece cooperatively position said sample probe of an analyzer to said sample site; and

wherein said sample site varies with said change in tissue state.

17. The adaptive mount of claim 16, wherein said change in tissue state comprises any of:

an elongation;

a contraction; and

a twist.

18. The adaptive mount of claim 16, wherein distance between said first alignment piece and said second alignment piece varies with tissue state and said distance is nominally unchanged during the step of coupling of said mount to said sample probe.

19. The mount of claim 16, wherein said analyzer comprises a noninvasive near-infrared based glucose concentration analyzer.