Analyte concentration detection devices and methods

• US 7,427,377 B2
• Filed: 05/10/2005
• Issued: 09/23/2008
• Est. Priority Date: 03/24/2003
• Status: Expired due to Term

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Intuity Medical, Inc.
• Inventors: Zanzucchi, Peter J., McBride, Sterling E., Tsekoun, Alexei Guennadievich
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): JARRETT, LORE RAMILLANO
• Application Number:
  US11/125,107
• Publication Number:
  US 20050202567A1
• Time in Patent Office: 1,232 Days
• Field of Search: 442/100, 604/890.1, 702/55, 600/575, 422 8205-100, 422/82.11
• US Class Current: 422/82.05
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 2021/0325 Cells for testing reactions, e.g. containing reagents
• CPC Class Codes: G01N 2021/0346 Capillary cells; Microcells
• CPC Class Codes: G01N 21/03 Cuvette constructions
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: G01N 21/7703 using reagent-clad optical fibres or optical waveguides using measurement of total internal reflection or attenuated total reflection G01N21/552; optical fibres or waveguides per se G02B
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/54373 : involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
• CPC Class Codes: Y10T 436/144444 : Glucose

Abstract

Arrangements for the detection of the presence and/or concentration of an analyte in a sample of bodily fluid include diffuse transmission, diffuse reflection and edge or waveguide illumination arrangements. A vertical flow assay arrangement and/or technique is also disclosed, and includes a detection component that can be in the form of an array of optical detection elements. A number of assay pad constructions are described which may include at least one or more of the following components: a prefilter component, a reflective component, a membrane component, a reagent component, a mesh component, and a component to prevent lateral spreading.

Claims

1. An arrangement for use in detecting the presence or concentration of an analyte present in bodily fluid, the arrangement comprising:

(a) an assay pad adapted to receive a sample of the bodily fluid, the assay pad containing a reagent;

(b) an array of CMOS detectors, each detector adapted to produce a signal indicative of a reaction between the analyte and the reagent; and

(c) electronics monitoring and interpreting the signals produced by the detectors to estimate the volume of the sample under analysis based on the number of CMOS detectors producing a signal indicative of the reaction between the analyte and the reagent.

2. The arrangement of claim 1, wherein the electronics further comprise at least one corrective algorithm.

3. The arrangement of claim 1, wherein the electronics generate an overall reading based on the signals produced by the individual detectors.

4. The arrangement of claim 1, further comprising a skin penetration member.

5. The arrangement of claim 4, wherein the skin penetration member comprises a microneedle.

6. The arrangement of claim 1, further comprising a chamber for receiving the sample of bodily fluid.

7. The arrangement of claim 6, wherein the assay pad is disposed in the chamber.

8. The arrangement of claim 1, further comprising at least one light source adapted to provide light incident upon the assay pad.

9. The arrangement of claim 1, wherein at least one dimension of the linear array is commensurate to at least one dimension of the assay pad.

10. A method useful in detecting the presence or concentration of an analyte present in bodily fluid, the method comprising:

(a) introducing a sample of the bodily fluid onto an assay pad, the assay pad containing a reagent;

(b) monitoring a reaction between the analyte and the reagent, comprising an array of CMOS detectors wherein at least one CMOS detector provides a signal in response to the reaction; and

(c) monitoring and interpreting the at least one signal to provide an estimate of the volume of the sample under analysis based on the number of CMOS detectors producing a signal indicative of the reaction between the analyte and the reagent.

11. The method of claim 10, wherein step c) further comprises applying at least one corrective algorithm to the at least one signal.

12. The method of claim 10, wherein step c) further comprises generating an overall reading based on the signals produced by the individual detectors.

13. The method of claim 10, further comprising providing a skin penetration member.

14. The method of claim 13, wherein the skin penetration member comprises a microneedle.

15. The method of claim 10, further comprising providing a chamber for receiving the sample of bodily fluid.

16. The method of claim 15, wherein step a) further comprises disposing the assay pad in the chamber.

17. The method of claim 10, further comprising providing light incident upon the assay pad.

18. The method of claim 10, further comprising providing the linear assay with at least one dimension commensurate to at least one dimension of the assay pad.