Small Volume in Vitro Analyte Sensor and Methods

• US 20020157948A2
• Filed: 12/28/2001
• Published: 10/31/2002
• Est. Priority Date: 11/04/1999
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Therasense Incorporated (Abbott Laboratories Incorporated)
• Inventors: Krishnan, Rajesh, Jin, Robert Y., Plante, Phillip John, Feldman, Benjamin J., Funderburk, Jeffery V., Vivolo, Joseph A., Cloud, Michael S., Liamos, Charles T.
• Granted Patent: US 6,942,518 B2
• Time in Patent Office: Days
• US Class Current: 204/403.01
• 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: Y10S 439/909 Medical use or attached to human body

Abstract

Abstract of Disclosure

A small volume sensor, and methods of making, for determining the concentration of an analyte, such as glucose or lactate, in a biological fluid, such as blood or serum, using techniques such as coulometry, amperometry, and potentiometry. The sensor includes a working electrode and a counter electrode, and can include an insertion monitoring trace to determine correct positioning of the sensor in a connector. In one embodiment, the sensor determines the concentration of the analyte by discharging an amount of charge into the sample, determining the time needed to discharge the charge, and determining the current used to electrolyze a portion of the analyte using the amount of charge and the amount of time.

Claims

1. An electrode connector for use in measuring a bioanalyte in a sample, the sample being present in a sensor strip;

the connector comprising;

(a) a sensor strip receiving area sized for selective receipt therein of a first end of a sensor strip having first and second, opposite, side edges;

(b) a first electrical contact structure comprising at least three contact leads oriented for each one to separately contact a separate electrode trace in the first end of the sensor strip when the first end of the sensor strip is operatively positioned in the sensor strip receiving area; and

(c) a second electrical contact structure comprising a first insertion lead and a second insertion lead, each of which is positioned to contact an insertion monitor stripe at the sensor strip first end when the sensor strip first end is operatively positioned in the sensor strip receiving area;

(i) the first insertion lead being oriented to extend across the first side edge of the sensor strip, to engage the insertion monitor stripe, when the first end of the sensor strip is operatively positioned in the sensor strip receiving area; and

,

(ii) the second insertion lead being oriented to extend across the second side edge of the sensor strip, to engage the insertion monitor stripe, when the first end of the sensor strip is operatively positioned in the sensor strip receiving area.

2. The connector according to claim 1, wherein:

(a) the at least three contact leads of the first contact structure extend across a first end edge of the sensor strip, when the first end of the sensor strip is operatively positioned in the sensor strip receiving area, the first end edge being adjacent the first end.

3. The connector according to claim 2, wherein:

(a) the at least three contact leads terminate a first distance from the first end edge of the sensor strip;

(b) the first insertion lead and the second insertion lead terminate a second distance from the first end edge; and

(c) the second distance is greater than the first distance.

4. The connector according to claim 3, wherein the first insertion lead and the second insertion lead, at a third distance from the first end edge, angle toward a longitudinal centerline of the sensor strip, the third distance being greater than the first distance and less than the second distance.

5. The connector according to claim 1, wherein the first contact structure further comprises a fourth contact lead.

6. The connector according to claim 1, wherein the electrode connector comprises a two-part structure having a top portion and a bottom portion, the top portion being removable from the bottom portion, the first contact structure being between the top portion and the bottom portion when the top portion and the bottom portion are assembled.

7. The connector according to claim 1, wherein the electrode connector is electrically connected to a sensor meter that comprises:

(a) a component to selectively provide at least one of potential and current to the first contact structure;

(b) a processor to selectively determine analyte concentration from a sensor signal; and

(c) a display to selectively show results determined from the sensor signal.

8. A connector comprising:

(a) a plurality of contact leads for electrical connection to an electrochemical analyte sensor, each contact lead having a proximal end for electrical connection to a contact on the analyte sensor, and a distal end for electrical connection to an electrical device;

wherein the plurality of contact leads comprises;

(i) one or more first contact leads extending longitudinally from the distal end to the proximal end; and

(ii) one or more second contact leads extending longitudinally from the distal end past the proximal end of the one or more first contact leads and angling toward a longitudinal center line of the sensor.

9. The connector of claim 8, wherein the connector comprises at least two second contact leads configured to make electrical contact with a single conductive surface of the sensor when the analyte sensor is electrically connected to the connector.

10. The connector of claim 9, wherein the first contact leads are configured and arranged to contact at least one of a working electrode and a counter electrode of a sensor, and wherein the second contact leads are configured and arranged to contact an insertion monitor of a sensor.