Analyte sensor with insertion monitor, and methods

Abstract

A 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.

1 .- 19 . (canceled) 
   
   
       20 . An electrochemical sensor strip for determining a concentration of ketone bodies in blood or interstitial fluid, the sensor comprising:
 a first substrate having a first major surface and a second major surface opposing the first major surface, the first substrate defining a proximal end of the strip, a distal end of the strip and first and second side edges of the strip extending from the proximal end to the distal end;   a second substrate having a first major surface and a second major surface opposing the first major surface, the first and second substrates being disposed so that the first major surface of the first substrate is in facing relationship with the first major surface of the second substrate;   spacer material disposed between the first substrate and the second substrate, the spacer material, the first substrate and the second substrate further defining:
 a first aperture along the proximal end and between the substrates, 
 a second aperture along the first side edge and between the substrates, 
 a channel leading from the first aperture to the second aperture, and 
 a sample chamber adjacent the first aperture and along the channel, the sample chamber comprising a measurement zone having a volume of no more than 1 μL; 
   a working electrode disposed on the first major surface of the first substrate;   a ketone body responsive enzyme disposed on the working electrode;   a counter electrode disposed on the first major surface of one of the first substrate and the second substrate, the working electrode and the counter electrode being positioned relative to the sample chamber to generate a ketone body responsive signal when sample containing ketone bodies is disposed in the measurement zone; and   an insertion monitor disposed on one of the first and the second major surfaces of one of the first substrate and the second substrate, the insertion monitor including a conductive stripe extending across a width of the sensor strip and the insertion monitor providing a path for electrical current between at least two contact leads of a meter.   
   
   
       21 . The sensor according to  claim 20 , wherein the insertion monitor is disposed on the second major surface of the first substrate. 
   
   
       22 . The sensor according to  claim 20 , wherein the counter electrode is disposed on the first major surface of the second substrate. 
   
   
       23 . The sensor according to  claim 20 , wherein the insertion monitor has two or more contact regions for electrical contact with the meter. 
   
   
       24 . The sensor according to  claim 20 , wherein the insertion monitor is configured and arranged to provide encoded information about the strip. 
   
   
       25 . An electrochemical sensor strip for determining the level of ketone bodies in a sample of blood or interstitial fluid, the sensor strip having a first side edge and a second side edge, the sensor strip comprising:
 a first substrate having a first major surface and a second major surface opposing the first major surface, the first substrate defining a proximal end of the strip, a distal end of the strip and first and second side edges of the strip extending from the proximal end to the distal end;   a second substrate having a first major surface and a second major surface opposing the first major surface, the first and second substrates being disposed so that the first major surface of the first substrate is in facing relationship with the first major surface of the second substrate;   spacer material disposed between the first substrate and the second substrate, the spacer material, the first substrate and the second substrate further defining:
 a first aperture along the proximal end and between the substrates, 
 a second aperture along the first side edge and between the substrates, 
 a channel leading from the first aperture to the second aperture, and 
 a sample chamber adjacent the first aperture, the sample chamber comprising a measurement zone having a volume of no more than 1 μL; 
   a working electrode on the first major surface of the first substrate;   a ketone body responsive enzyme disposed on the working electrode;   a counter electrode on the first major surface of one of the first substrate and the second substrate, the working electrode and the counter electrode being positioned relative to the sample chamber to generate a ketone body responsive signal when sample containing ketone bodies is disposed in the measurement zone; and   an insertion monitor comprising electrically conductive material forming a stripe extending from the first side edge to the second side edge of the sensor strip on one of the substrate surfaces.   
   
   
       26 . The sensor strip of  claim 25 , comprising two working electrodes. 
   
   
       27 . The sensor strip of claim  5 , wherein the counter electrode is on the first major surface of the second substrate.