Method and apparatus for measuring analytes

• US 8,597,208 B2
• Filed: 08/08/2006
• Issued: 12/03/2013
• Est. Priority Date: 09/06/2005
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: MacIntyre, Duncan, Kaushal, Ash, Endersby, Paul
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US11/463,232
• Publication Number:
  US 20070110621A1
• Time in Patent Office: 2,674 Days
• Field of Search: 600/584, 600/583, 600/573
• US Class Current: 600/583
• 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 a compound in the blood of a part of a subject is provided. An invasive or non-invasive sample of blood may used for this determination. Also provided is a device for measuring the concentration of a compound in the blood of a subject.

Claims

1. A device for measuring a concentration of one or more than one compound in a sample derived from a body part of a subject, wherein the sample is measured on the surface of the body part without handling of the 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 probe comprising one or more than one input radiation guiding element in operable association with the source of EMR, one or more than one output radiation guiding element in operable association with a detector, the one or more than one input radiation guiding element and the one or more than one output radiation guiding element optically aligned with one or more than one port located within the probe to define-an EMR path through the probe;

a detachable receptor received within the probe and sized to receive the body part, the receptor comprising one or more than one port in optical alignment with the one or more than one port located within the probe to further define the EMR path through the probe and within the receptor;

a lancing device and a guide for targeting the lancing device, the lancing device and guide positioned within the receptor to produce a sample from the body part that is disposed on the surface of the body part and directly within the EMR path; and

a detector for measuring transmitted or reflected EMR received directly from the sample on the surface of the body part without handling of the sample; and

a processing system operatively coupled to the detector, comprising one, or more than one calibration algorithm for determining a concentration for the one or more than one compound;

wherein the probe and the receptor received within the probe are removable from the source of EMR, the detector, or both the source of EMR and detector, and are optically associated with the source of EMR and the detector.

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

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

4. The device according to claim 1 comprising a second path of EMR through the probe 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 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_lc, 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⁻

and HPO₄⁻

.

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

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

8. A method of determining the concentration of one or more than one compound in a sample of blood on the surface of a body part of a subject without handling of the sample, using the device defined in claim 1, comprising,

(a) placing the receptor of the device according to claim 1 over a portion of a body part, the body part having a sample of blood thereon,

(b) directing the source of electromagnetic radiation (EMR) of the device according to claim 1 through the receptor and directly onto the sample of blood disposed on the body part;

(c) measuring on the surface of the body part without handling of the sample, a quantity of the EMR reflected by, or transmitted through, the sample of blood with the detector of the device according to claim 1; and

(d) performing a quantitative mathematical analysis of the quantity of EMR using the one, or more than one calibration algorithm of the processing system of the device according to claim 1, and determining the concentration of the one or more than one compound in the sample of blood.

9. The method according to claim 8, 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_lc, 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⁻

and HPO₄⁻

.

10. The method according to claim 8, 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 and directly within the EMR path.

11. The method according to claim 8, wherein prior to the step of placing (step (a)), the receptor is placed within a probe.

12. The method according to claim 11, wherein after the step of measuring (step (c)) the receptor is removed from the probe.

13. The method according to claim 8, wherein in the step of directing (step b)), the source of EMR comprises wavelengths from about 300 nm to about 2500 nm.

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

15. The method according to claim 8, 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.

16. The method according to claim 8, 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.

17. A method of determining the concentration of one or more than one compound in a sample of blood on the surface of a body part of a subject without handling of the sample, using the device defined in claim 1, comprising,

(a) placing the receptor of the device according to claim 1 over a portion of a body part;

(b) lancing the body part located within the receptor with the lancing device to produce a sample of blood from the body part that is disposed on the surface of the body part and directly within the EMR path,

(c) directing the source of electromagnetic radiation (EMR) of the device according to claim 1 through the receptor and directly onto the sample of blood disposed on the surface of the body part;

(d) measuring on the surface of the body part without handling of the sample, a quantity of the EMR reflected by, or transmitted through, the sample of blood with the detector of the device according to claim 1; and

(e) performing a quantitative mathematical analysis of the quantity of EMR using the one, or more than one calibration algorithm of the processing system of the device according claim 1, and determining the concentration of the one or more than one compound in the sample of blood.

18. The method according to claim 17, 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_lc, 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⁻

and HPO₄⁻

.

19. The method according to claim 17, wherein prior to the step of placing (step (a)), the receptor is placed within a probe.

20. The method according to claim 19, wherein after the step of measuring (step (d)) the receptor is removed from the probe.

21. The method according to claim 17, wherein the source of EMR comprises wavelengths from about 300 nm to about 2500 nm.

22. The method according to claim 17, wherein the source of EMR comprises wavelengths from about 500 nm to about 1100 nm.

23. The device according to claim 5, wherein the fatty acid is an omega-3 fatty acid, an omega-6 fatty acid, or an omega-9 fatty acid.

24. The device according to claim 23, wherein the omega-3 fatty acid is α

-linolenic acid, eicosapentaenoic acid, or docosahexaenoic acid.

25. The device according to claim 23, 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.

26. The device according to claim 23, wherein the omega-9 fatty acid is oleic acid, eicosenoic acid, mead acid, erucic acid or nervonic acid.

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

28. The method according to claim 27, wherein the omega-3 fatty acid is α

-linolenic acid, eicosapentaenoic acid, or docosahexaenoic acid.

29. The method according to claim 27, 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.

30. The method according to claim 27, wherein the omega-9 fatty acid is oleic acid, eicosenoic acid, mead acid, erucic acid or nervonic acid.

31. The method according to claim 18, wherein the fatty acid is an omega-3 fatty acid, an omega-6 fatty acid, or an omega-9 fatty acid.

32. The method according to claim 31, wherein the omega-3 fatty acid is α

-linolenic acid, eicosapentaenoic acid, or docosahexaenoic acid.

33. The method according to claim 31, 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.

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