Method and device for sampling and analyzing interstitial fluid and whole blood samples

Abstract

The invention disclosed in this application is a method and device for combining the sampling and analyzing of sub-dermal fluid samples, e.g., interstitial fluid or whole blood, in a device suitable for hospital bedside and home use. It is applicable to any analyte that exists in a usefully representative concentration in the fluid, and is especially suited to the monitoring of glucose.

1 . A fluid sampling device, the device comprising a test strip, wherein the test strip comprises: 
 (a) an upper surface;    (b) a lower surface;    (c) an analysis chamber defined between the upper surface and the lower surface, wherein the analysis chamber comprises a proximal end and a distal end, a first analysis chamber wall, a second analysis chamber wall, a volume, a working electrode and a counter and/or reference electrode;    (d) an opening for admitting a sample comprising an analyte to the analysis chamber;    (e) an opening to the atmosphere on the distal end of the analysis chamber; and    (f) an interface for communication with a meter, wherein the interface comprises conductive leads from the electrodes for obtaining an electrochemical measurement.    
   
   
       2 . The device of  claim 1 , wherein an electrode of the analysis chamber is disposed on the upper surface.  
   
   
       3 . The device of  claim 2 , wherein the electrode is the working electrode.  
   
   
       4 . The device of  claim 1 , wherein an electrode of the analysis chamber is disposed on the lower surface.  
   
   
       5 . The device of  claim 4 , wherein the electrode is the counter and/or reference electrode.  
   
   
       6 . The device of  claim 1 , wherein the upper and lower surfaces are covered by laminating layers.  
   
   
       7 . The device of  claim 1 , wherein the electrodes are comprised of a metal selected from a group consisting of palladium, gold, platinum, iridium and silver.  
   
   
       8 . The device of  claim 1 , wherein a flow of sample to the analysis chamber is driven by a driving force, wherein the driving force comprises a capillary force.  
   
   
       9 . The device of  claim 1 , wherein the analysis chamber comprises a substance capable of enhancing or diminishing a capillary force.  
   
   
       10 . The device of  claim 9 , wherein the substance is selected from a group consisting of a polymer, a resin, a powder, a mesh, a fibrous material, a crystalline material, a porous material, and a combination thereof.  
   
   
       11 . The device of  claim 10 , wherein the substance is selected form the group consisting of polyethylene glycol, polyvinyl pyrrolidone, a surfactant, a hydrophilic block copolymer, and polyvinylacetate.  
   
   
       12 . The device of  claim 1 , wherein the analysis chamber is integrated with a means for facilitating filing of the analysis chamber.  
   
   
       13 . The device of  claim 12 , the means is a penetration probe.  
   
   
       14 . The device of  claim 1 , wherein the analysis chamber comprises a porous membrane.  
   
   
       15 . The device of  claim 1 , wherein the volume of the analysis chamber is less than 1.5 μl.  
   
   
       16 . The device of  claim 1 , wherein the analysis chamber contains one or more reagents capable of reacting with the analyte or a substance in the sample.  
   
   
       17 . The device of  claim 1 , wherein the sample is selected from the group consisting of interstitial fluid and whole blood.  
   
   
       18 . The device of  claim 1 , wherein the analyte is selected from the group consisting of an ion, an element, a sugar, an alcohol, a hormone, a protein, an enzyme, a cofactor, a nucleic acid sequence, a lipid, a pharmaceutical, and a drug.  
   
   
       19 . The device of  claim 1 , wherein the analyte is selected from the group consisting of a potassium ion, ethanol, cholesterol, glucose, and lactate.