Method and apparatus for measuring analytes

• US 8,523,785 B2
• Filed: 08/24/2006
• Issued: 09/03/2013
• Est. Priority Date: 09/06/2005
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Kaushal, Ash, MacIntyre, Duncan
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): DANEGA, RENEE A
• Application Number:
  US12/066,072
• Publication Number:
  US 20090168049A1
• Time in Patent Office: 2,567 Days
• Field of Search: 600/583, 600/573, 422/82.05
• 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 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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
• CPC Class Codes: G01N 2201/08 Optical fibres; light guides

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 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 method of determining the concentration of one or more than one compound in a sample comprising,

(a) placing a receptor over a portion of a body part, and either (i) directing a source of electromagnetic radiation (EMR) through the receptor and the body part;

(ii) lancing the body part to obtain sample of blood and directing the source of electromagnetic radiation (EMR) through the receptor and the sample of blood;

or (iii) directing the source of electromagnetic radiation (EMR) through the receptor and the body part, and lancing the body part to obtain sample of blood and directing the source of electromagnetic radiation (EMR) through the receptor and the sample of blood;

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

(c) 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 body part, the sample of blood, or both the body part and the sample of blood, wherein the one or more than one compound may be selected from the group consisting of a neutral or ionic form of a heavy metal having an atomic number greater than 20,

wherein prior to the step of directing the EMR on the body part, in steps a) i) or a) iii), the body part is squeezed so that a substantial portion of the blood is removed from the body part to produce a squeezed body part, the EMR is directed onto the squeezed body part, and the one or more than one compound is determined within the squeezed body part.

2. The method claim 1, wherein prior to the step of placing (step (a)), the receptor is placed within a holder.

3. The method of claim 1, wherein after the step of measuring (step (b)) the receptor is removed from the holder.

4. The method according to claim 1, wherein in the step of directing (step (a)), the source of EMR comprises wavelengths from about 300 nm to about 2500 nm.

5. The method according to claim 1, wherein in the step of directing (step (a)), the source of EMR comprises wavelengths from about 500 nm to about 1100 nm.

6. The method of claim 1, wherein in the step of directing (step (a)), a second source of EMR is directed to the body part, and a measurement of background is obtained.

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

(a) placing a receptor over a portion of a body part, and either (i) directing a source of electromagnetic radiation (EMR) through the receptor and the body part;

(ii) lancing the body part to obtain sample of blood and directing the source of electromagnetic radiation (EMR) through the receptor and the sample of blood;

or (iii) directing the source of electromagnetic radiation (EMR) through the receptor and the body part, and lancing the body part to obtain sample of blood and directing the source of electromagnetic radiation (EMR) through the receptor and the sample of blood;

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

(c) 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 body part, the sample of blood, or both the body part and the sample of blood, wherein the one or more than one compound may be selected from the group consisting of a neutral or ionic form of a heavy metal having an atomic number greater than 20,

wherein in the step of directing the EMR on the body part, in steps a) i) or a) iii),

     1) the EMR is directed onto the body part, and the one or more than one compound is determined within the body part to produce a total value of the one or more than one compound,

     2) the body part is then squeezed so that a substantial portion of the blood is removed from the body part to produce a squeezed body part, the EMR is directed onto the squeezed body part, and the one or more than one compound is determined within the squeezed body part to produce a tissue value of the one or more than one compound; and

optionally,

     3) determining the blood value of the one or more than one compound by subtracting the tissue value from the total value to obtain the blood value of the one or more than one compound.

8. The method claim 7, wherein prior to the step of placing (step (a)), the receptor is placed within a holder.

9. The method of claim 7, wherein after the step of measuring (step (b)) the receptor is removed from the holder.

10. The method according to claim 7, wherein in the step of directing (step (a)), the source of EMR comprises wavelengths from about 300 nm to about 2500 nm.

11. The method according to claim 7, wherein in the step of directing (step (a)), the source of EMR comprises wavelengths from about 500 nm to about 1100 nm.

12. The method of claim 7, wherein in the step of directing (step (a)), a second source of EMR is directed to the body part, and a measurement of background is obtained.