METHOD AND APPARATUS FOR MEASURING ANALYTES

• US 20090221886A1
• Filed: 08/09/2006
• Published: 09/03/2009
• Est. Priority Date: 09/06/2005
• Status: Abandoned Application

• Current Assignee: NIR Diagnostics Incorporated
• Original Assignee: NIR Diagnostics Incorporated
• Inventors: Endersby, Paul, MacIntyre, Duncan, Kaushal, Ash
• Application Number:
  US12/066,065
• Publication Number:
  US 20090221886A1
• Time in Patent Office: Days
• US Class Current: 600/316
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 2021/3144 for oxymetry
• CPC Class Codes: G01N 21/359 using near infrared light

Abstract

A method for measuring the concentration of various analytes in the blood of a part of a subject is provided An invasive or non-invasive sample of blood may be used for this determination Also provided is a device for measuring the concentration of a compound in the blood of a subject. The device comprises a source of electromagnetic radiation, a holder, a detector and a processing system.

Claims

1. A device for measuring a concentration of one or more than one compound in a sample, comprising:

a source of electromagnetic radiation (EMR) that emits one or more than one wavelength of EMR, the source of EMR being operatively coupled to a power source;

a holder for receiving a detachable receptor, the holder comprising one or more than one input in operable association with the source of EMR, one or more than one output in operable association with a detector, the one or more than one input and the one or more than output of the holder in optical alignment with one or more than one port located within the receptor, the one or more than one input and the one or more than output defining an EMR path through the holder and within the receptor, wherein, the sample when received by the receptor is placed within the EMR path;

the detector for measuring transmitted or reflected EMR received from the sample, the detector operatively coupled to a processing system;

the processing system comprising one, or more than one calibration algorithm for determining a concentration for the one or more than one compound.

2. The device of claim 1, wherein the detachable receptor is sized to fit over a portion of a body part.

3. The device of claim 2, wherein the detachable receptor is sized to fit over a drop of blood located on the body part.

4. The device of claim 1 comprising a second path of EMR through the holder and within the detachable receptor, wherein the second path of EMR interacts with the sample at a location separate from that of the EMR path, the second path of EMR is in operative association with the source of EMR or a second source of EMR.

5. The device of claim 1, wherein the detachable receptor or the holder further comprises an apparatus for lancing a body part when the body part is positioned with the receptor.

6. The device of claim 1 wherein the holder is a probe, the probe being removable from the source of EMR, the detector, or both the source of EMR and detector, and the probe being optically associated with the source of EMR and the detector.

7. The device of claim 1, wherein the receptor comprises a matrix that can wick the sample off a surface of a body part.

8. The device according to claim 1, wherein the compound is selected from the group consisting of hemoglobin, Oxy-Hb, % oxy-Hb, “

Oxy-Hb plus Deoxy-Hb”

, “

Total-Hb minus Met-Hb”

, Met-Hb, % met-Hb, Carboxy-Hb, % CO-Hb, Sulf-Hb, HbA_1c, cholesterol, glucose, a fat, a protein, a glycoprotein, a lipoprotein, a carbohydrate, a steroid, an amino acid, nitrogen, carbon dioxide, cortisol, creatine, creatinine, a ketone, a lipid, urea, a fatty acid, glycosolated hemoglobin, alcohol, lactate, an ion, Ca²⁺, K⁺, Cl⁻

, HCO₃⁻

, HPO₄⁻

and an antioxidant.

9. The device according to claim 1, wherein the source of EMR comprises wavelengths from about 300 nm to about 2500 nm n.

10. The device according to claim 1, wherein the source of EMR comprises wavelengths from about 500 nm to about 1100 nm.

28. The device according to claim 8, wherein the fatty acid is an omega-3 fatty acid, an omega-6 fatty acid, or an omega-9 fatty acid.

29. The device according to claim 28, wherein the omega-3 fatty acid is α

-linolenic acid, eicosapentaenoic acid, or docosahexaenoic acid.

30. The device according to claim 28, wherein the omega-6 fatty acid is linoleic acid, gamma-linolenic acid, eicosadienoic acid, dihomo-gamma-linolenic acid, arachidonic acid, docosadienoic acid, adrenic acid, or docosapentaenoic acid.

31. The device according to claim 28, wherein the omega-9 fatty acid is oleic acid, eicosenoic acid, mead acid, erucic acid or nervonic acid.

40. The device according to claim 8, wherein the antioxidant is Vitamin E.

11. A method of determining the concentration of one or more than one compound in a sample of blood comprising,

(a) placing a receptor over a portion of a body part, the body part having a sample of blood thereon,

(b) directing a source of electromagnetic radiation (EMR) through the receptor and onto the sample of blood;

(c) measuring a quantity of the EMR reflected by, or transmitted through, the sample of blood with a detector; and

(d) performing a quantitative mathematical analysis of the quantity of EMR using an algorithm, and determining the concentration of the one or more than one compound in the sample of blood.

12. The method according to claim 11, wherein the one or more than one compound is selected from the group consisting of a fat, a protein, a glycoprotein, hemoglobin, Oxy-Hb, % oxy-Hb, “

Oxy-Hb plus Deoxy-Hb”

, “

Total-Hb minus Met-Hb”

, Met-Hb, % met-Hb, Carboxy-Hb, Co-Hb, Sulf-Hb, HbA_1c, cholesterol, glucose, a fat, a protein, a glycoprotein, a lipoprotein, a carbohydrate, a steroid, an amino acid, nitrogen, carbon dioxide, cortisol, creatine, creatinine, a ketone, a lipid, urea, a fatty acid, glycosolated hemoglobin, alcohol, lactate, an ion, Ca²⁺, K⁺, Cl⁻

, HCO₃⁻

, HPO₄⁻

and an antioxidant.

13. The method of claim 11, wherein prior to the step of placing (step a)), the body part is lanced so that the sample of blood is produced on the surface of the body part.

14. The method claim 11, wherein prior to the step of placing (step (a)), the receptor is placed within a holder.

15. The method of claim 11, wherein after the step of measuring (step (c)) the receptor is removed from the holder.

16. The method according to claim 11, wherein in the step of measuring (step (b)), the source of EMR comprises wavelengths from about 300 nm to about 2500 nm.

17. The method according to claim 11, wherein in the step of measuring (step (b)), the source of EMR comprises wavelengths from about 500 nm to about 1100 nm.

18. The method of claim 11, wherein in the step of placing (step (a)), the sample is wicked within the receptor.

19. The method of claim 11, wherein in the step of directing (step (b)), a second source of EMR is directed to the body part, and a measurement of background is obtained.

20. The method of claim 11, wherein in the step of directing (step (b)), a second source of EMR is directed to the body part, and in the step of measuring (step (c)), a non-invasive measurement is made of one or more compound within the body part.

32. The method according to claim 12, wherein the fatty acid is an omega-3 fatty acid, an omega-6 fatty acid, or an omega-9 fatty acid.

33. The method according to claim 32, wherein the omega-3 fatty acid is α

-linolenic acid, eicosapentaenoic acid, or docosahexaenoic acid.

34. The method according to claim 32, wherein the omega-6 fatty acid is linoleic acid, gamma-linolenic acid, eicosadienoic acid, dihomo-gamma-linolenic acid, arachidonic acid, docosadienoic acid, adrenic acid, or docosapentaenoic acid.

35. The method according to claim 32, wherein the omega-9 fatty acid is oleic acid, eicosenoic acid, mead acid, erucic acid or nervonic acid.

41. The method according to claim 12, wherein the antioxidant is Vitamin E.

21. A method of determining the concentration of one or more than one compound in a sample of blood comprising,

(a) placing a receptor over a portion of a body part;

(b) lancing the body part located within the receptor to produce a sample of blood on the surface of the body part,

(c) directing a source of electromagnetic radiation (EMR) through the receptor and onto the sample of blood;

(d) measuring a quantity of the EMR reflected by, or transmitted through, the sample of blood with a detector; and

(e) performing a quantitative mathematical analysis of the quantity of EMR using an algorithm, and determining the concentration of the one or more than one compound in the sample of blood.

22. The method according to claim 21, wherein the compound is selected from the group consisting of a fat, a protein, a glycoprotein, hemoglobin, Oxy-Hb, % oxy-Hb, “

Oxy-Hb plus Deoxy-Hb”

, “

Total-Hb minus Met-Hb”

, Met-Hb, % met-Hb, Carboxy-Hb, % CO-Hb, Sulf-Hb, HbA_1c, cholesterol, glucose, a fat, a protein, a glycoprotein, a lipoprotein, a carbohydrate, a steroid, an amino acid, nitrogen, carbon dioxide, cortisol, creatine, creatinine, a ketone, a lipid, urea, a fatty acid, glycosolated hemoglobin, alcohol, lactate, an ion, Ca²⁺, K⁺, Cl⁻

, HCO₃⁻

, HPO₄⁻

and an antioxidant.

23. The method claim 21, wherein prior to the step of placing (step (a)), the receptor is placed within a holder.

24. The method of claim 23, wherein after the step of measuring (step (d)) the receptor is removed from the holder.

25. The device according to claim 21, wherein the source of EMR comprises wavelengths from about 300 nm to about 2500 nm.

26. The device according to claim 21, wherein the source of EMR comprises wavelengths from about 500 nm to about 1100 nm.

27. The method of claim 21, wherein in the step of lancing (step (b)), the sample is wicked within the receptor.

36. The device according to claim 22, wherein the fatty acid is an omega-3 fatty acid, an omega-6 fatty acid, or an omega-9 fatty acid.

37. The method according to claim 36, wherein the omega-3 fatty acid is u-linolenic acid, eicosapentaenoic acid, or docosahexaenoic acid.

38. The method according to claim 36, wherein the omega-6 fatty acid is linoleic acid, gamma-linolenic acid, eicosadienoic acid, dihomo-gamma-linolenic acid, arachidonic acid, docosadienoic acid, adrenic acid, or docosapentaenoic acid.

39. The method according to claim 36, wherein the omega-9 fatty acid is oleic acid, eicosenoic acid, mead acid, erucic acid or nervonic acid.

42. The method according to claim 22, wherein the antioxidant is Vitamin E.