Analyte concentration detection devices and methods

• US 9,095,292 B2
• Filed: 07/30/2012
• Issued: 08/04/2015
• Est. Priority Date: 03/24/2003
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Intuity Medical, Inc.
• Inventors: Zanzucchi, Peter J., McBride, Sterling E., Tsekoun, Alexei Guennadievich
• Primary Examiner(s): Jarrett, Lore
• Application Number:
  US13/562,129
• Publication Number:
  US 20120296179A1
• Time in Patent Office: 1,100 Days
• US Class Current: 1/1
• 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. A device for conducting an assay to determine the concentration of an analyte in a sample of bodily fluid, the device comprising:

a microneedle configured to collect the sample and comprising a lumen therethrough;

an elongate sample collection channel transverse to the lumen of the microneedle, wherein the sample collection channel comprises a proximal end and a distal end, and wherein the proximal end is in communication with the lumen of the microneedle;

an assay pad comprising a reagent that produces a reaction when exposed to the analyte, wherein the assay pad is in communication with the sample collection channel along a length between the proximal and distal ends of the sample collection channel; and

a linear array of detectors configured to scan a line across the assay pad to detect the reaction.

2. The device of claim 1 wherein the linear array of detectors comprises a sensor, the sensor comprising a CMOS sensor, a CCD sensor, or a photodiode.

3. The device of claim 1, wherein the analyte comprises glucose.

4. The device of claim 1, wherein the linear array of detectors comprises a linear array of CMOS sensors.

5. The device of claim 1, further comprising a light source adapted to provide light incident upon the assay pad.

6. The device of claim 1, further comprising a lens disposed between the linear array of detectors and the assay pad.

7. The device of claim 6, wherein the lens is a refractive lens.

8. The device of claim 6, wherein the lens is a diffractive lens.