Analyte monitoring systems and methods

Abstract

A reagentless whole-blood analyte detection system that is capable of being deployed near a patient has a source capable of emitting a beam of radiation that includes a spectral band. The whole-blood system also has a detector in an optical path of the beam. The whole-blood system also has a housing that is configured to house the source and the detector. The whole-blood system also has a sample element that is situated in the optical path of the beam. The sample element has a sample cell and a sample cell wall that does not eliminate transmittance of the beam of radiation in the spectral band.

1 . A system for determining the level of an analyte in a biological fluid sample from a patient, the system comprising:
 an analyte detection system configured to determine the level of at least one analyte in the biological fluid sample;   a sample extractor configured to withdraw the biological fluid sample through the skin of the patient and into the analyte detection system; and   a sample element forming part of the analyte detection system, the sample element comprising:
 a sample cell; and 
 a sample supply passage in fluid communication with the sample cell, the sample supply passage comprising one or more ridges configured to enhance flow of the biological fluid sample through the sample supply passage; 
   wherein the sample cell is configured to receive at least a portion of the biological fluid sample through the sample supply passage.   
     
     
         2 . The system of  claim 1 , wherein the sample supply passage comprises a top surface and a bottom surface, and wherein the one or more ridges are formed at least on the top surface of the sample supply passage. 
     
     
         3 . The system of  claim 1 , wherein the one or more ridges are configured to urge the biological fluid sample into the sample cell. 
     
     
         4 . The system of  claim 1 , wherein the one or more ridges comprise pores or dimples. 
     
     
         5 . The system of  claim 1 , wherein the at least one component of the sample of bodily fluid comprises hemoglobin. 
     
     
         6 . The system of  claim 1 , wherein the biological fluid sample comprises whole blood. 
     
     
         7 . The system of  claim 1 , wherein the sample element is disposable after use. 
     
     
         8 . The system of  claim 1 , wherein the sample element further comprises a filter disposed in the sample supply passage, and wherein the filter is configured to filter out the at least one component of the biological fluid sample. 
     
     
         9 . The system of  claim 8 , wherein the filter uses either wicking or capillary action, or both, to transport the biological fluid sample through the sample supply passage to the sample cell. 
     
     
         10 . The system of  claim 8 , wherein the filter comprises a membrane. 
     
     
         11 . The system of  claim 10 , wherein the membrane is configured to facilitate a flow of the analyte therethrough. 
     
     
         12 . The system of  claim 1 , wherein the analyte detection system is configured to use a transmission of energy in or through the sample cell and a measurement thereof to determine the level of the analyte present in the at least one component of the biological fluid sample. 
     
     
         13 . The system of  claim 1 , wherein the sample element further comprises an opening at the end of the sample supply passage opposite the sample cell, and wherein the biological fluid sample flows into the sample supply passage via the opening. 
     
     
         14 . The system of  claim 13 , wherein the sample element further comprises a lance, wherein the lance positioned in the sample element such that a single motion create a wound and places the opening at the wound. 
     
     
         15 . The system of  claim 1 , wherein a thickness of the sample supply passage is between about 1 μm and about 1.22 mm. 
     
     
         16 . The system of  claim 1 , wherein the sample element further comprises an air vent passage configured to improve capillary action within the sample supply passage. 
     
     
         17 . The system of  claim 16 , wherein the sample cell is positioned between the sample supply passage and the air vent passage. 
     
     
         18 . The system of  claim 1 , wherein the sample supply passage comprises a pierceable portion, and wherein the sample extractor pierces the pierceable portion of the sample supply passage to provide an inlet for the biological fluid sample to enter the sample supply passage. 
     
     
         19 . The system of  claim 18 , wherein the pierceable portion comprises a seal configured to maintain a vacuum within the sample cell and the sample supply passage, wherein the seal serves as a barrier configured to prevent contaminants from entering the sample supply passage. 
     
     
         20 . The system of  claim 1 , wherein the one or more ridges are configured to urge the biological fluid sample to flow from the sample supply passage toward the sample cell.