System and methods for determining an analyte concentration incorporating a hematocrit correction

• US 8,529,741 B2
• Filed: 02/23/2012
• Issued: 09/10/2013
• Est. Priority Date: 09/05/2006
• Status: Active Grant

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Nipro Diagnostics, Inc.
• Inventors: Neel, Gary T., Bell, Douglas E., Slomski, Dennis, Deng, David Z.
• Primary Examiner(s): Ball, J. Christopher
• Assistant Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US13/403,318
• Publication Number:
  US 20120241318A1
• Time in Patent Office: 565 Days
• Field of Search: 204400-40315, 205/777.5, 205/778, 205/792, 600345-348, 422/68.1, 435/287.1
• US Class Current: 204/403.14
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

Methods and devices for determining the concentration of a constituent in a physiological sample are provided. The blood sample is introduced into a test strip with portions of the blood sample being directed to both a first capillary and a second capillary. The first capillary configured to electrochemically determine a concentration of a first analyte in a blood sample by measuring a signal across a set of electrodes. The second capillary is configured to determine a hematocrit value of the blood sample by measuring a signal across a second set of electrodes.

Claims

1. A biosensor for quantifying a concentration of an analyte in a blood sample, comprising:

a base layer having a distal end, a proximal end, and a top surface extending generally from the distal end to the proximal end;

a first chamber located above the top surface and having a first distal end and a first proximal end;

a second chamber located above the top surface and having a second distal end and a second proximal end, wherein the second proximal end is generally located at the proximal end of the base layer and the second distal end is fluidly connected to the first proximal end of the first chamber;

a first pair of electrodes disposed on the base layer and configured to determine a value corresponding to a hematocrit level of the blood sample, wherein a first portion of one of the first pair of electrodes is located in the first chamber, a second portion of the one of the first pair of electrodes is located in the second chamber, and the other of the first pair of electrodes is located in the second chamber; and

a second pair of electrodes disposed on the base layer and configured to determine a value corresponding to a concentration of the analyte in the blood sample, wherein one of the second pair of electrodes is the one of the first pair of electrodes having the first portion located in the first chamber and the second portion located in the second chamber, and the other of the second pair of electrodes is located in the first chamber.

2. The biosensor of claim 1, further including a third pair of electrodes disposed on the base layer and configured to determine filling of the first chamber, wherein one of the third pair of electrodes is the other of the second pair of electrodes located in the first chamber and the other of the third pair of electrodes is located in the first chamber.

3. The biosensor of claim 2, further including four electrode contacts located distally along the base layer, wherein the four electrode contacts are electrically connected to the first, second, and third pairs of electrodes.

4. The biosensor of claim 1, further including a reagent layer that extends generally from the first distal end of the first chamber to a distal region of the second chamber.

5. The biosensor of claim 1, wherein both the first proximal end of the first chamber and the second distal end of the second chamber share a continuous reagent layer.

6. The biosensor of claim 1, wherein a continuous reagent layer substantially covers both the first portion of one of the first pair of electrodes located in the first chamber and the second portion of one of the first pair of electrodes located in the second chamber.

7. The biosensor of claim 1, wherein the first pair of electrodes are separated by an electrically isolated region having a distance of at least 1 mm.

8. The biosensor of claim 7, wherein the first pair of electrodes are separated by an electrically isolated region having a distance of about 2 mm.

9. The biosensor of claim 1, wherein a lateral wall defining the first chamber and the second chamber includes a tapered surface.

10. The biosensor of claim 1, wherein a lateral wall defining the first chamber and the second chamber includes a flat continuous surface extending from the first chamber into the second chamber.

11. A system for quantifying a concentration of an analyte in a blood sample, comprising:

a biosensor, comprising;

a base layer having a distal end, a proximal end, and a top surface extending generally from the distal end to the proximal end;

a first chamber located above the top surface and having a first distal end and a first proximal end;

a second chamber located above the top surface and having a second distal end and a second proximal end, wherein the second proximal end is generally located at the proximal end of the base layer and the second distal end is fluidly connected to the first proximal end of the first chamber;

a first pair of electrodes disposed on the base layer, wherein a first portion of one of the first pair of electrodes is located in the first chamber, a second portion of the one of the first pair of electrodes is located in the second chamber, and the other of the first pair of electrodes is located in the second chamber; and

a second pair of electrodes disposed on the base layer, wherein one of the second pair of electrodes is the one of the first pair of electrodes having the first portion located in the first chamber and the second portion located in the second chamber, and the other of the second pair of electrodes is located in the first chamber; and

a meter configured to receive a first signal from the first pair of electrodes and a second signal from the from the second pair of electrodes, wherein the meter is configured to determine a value corresponding to a hematocrit level of the blood sample based on the first signal and determine a value corresponding to a concentration of the analyte in the blood sample based on the second signal.

12. The system of claim 11, wherein the biosensor further comprises:

a third pair of electrodes disposed on the base layer, wherein one of the third pair of electrodes is the other of the second pair of electrodes located in the first chamber and the other of the third pair of electrodes is located in the first chamber, and

four electrode contacts located distally along the base layer, wherein the four electrode contacts are electrically connected to the first, second, and third pairs of electrodes; and

the meter is further configured to electrically connect to the four electrode contacts and determine filling of the first chamber.

13. A method for manufacturing a biosensor, comprising:

forming a first chamber on a top surface of a base layer having a distal end and a proximal end, wherein the first chamber has a first distal end and a first proximal end;

forming a second chamber having a second distal end and a second proximal end on the top surface, wherein the second proximal end is generally located at the proximal end of the base layer and the second distal end is fluidly connected to the first proximal end of the first chamber;

forming a first pair of electrodes configured to determine a value corresponding to a hematocrit level of the blood sample on the base layer, wherein a first portion of one of the first pair of electrodes is located in the first chamber, a second portion of the one of the first pair of electrodes is located in the second chamber, and the other of the first pair of electrodes is located in the second chamber; and

forming a second pair of electrodes configured to determine a value corresponding to a concentration of the analyte in the blood sample on the base layer and, wherein one of the second pair of electrodes is the one of the first pair of electrodes having the first portion located in the first chamber and the second portion located in the second chamber, and the other of the second pair of electrodes is located in the first chamber.

14. The method of claim 13, further including forming a third pair of electrodes configured to determine filling of the first chamber on the base layer, wherein one of the third pair of electrodes is the other of the second pair of electrodes located in the first chamber and the other of the third pair of electrodes is located in the first chamber.

15. The method of claim 14, further including forming four electrode contacts at a distal location on the base layer, wherein the four electrode contacts are electrically connected to the first, second, and third pairs of electrodes.

16. The method of claim 13, further including forming a reagent layer generally from the first distal end of the first chamber to a distal region of the second chamber.

17. The method of claim 13, further including forming a continuous reagent layer over both the first proximal end of the first chamber and the second distal end of the second chamber.

18. The method of claim 13, further including forming a continuous reagent layer over both the first portion of one of the first pair of electrodes located in the first chamber and the second portion of one of the first pair of electrodes located in the second chamber.

19. The method of claim 13, further including forming an electrically isolated region having a distance of at least 1 mm between the first pair of electrodes.

20. The method of claim 19, further including forming an electrically isolated region having a distance of about 2 mm between the first pair of electrodes.