Systems and methods for analyzing bodily fluids

Abstract

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

1 .- 29 . (canceled) 
     
     
         30 . A method for programming a device capable of analyzing a bodily fluid, comprising:
 selecting by a prescribing physician or a drug company at least one threshold value of at least one analyte to be sensed by the device, the at least one threshold value of the at least one analyte being associated with a particular drug being or to be taken by the patient or course of treatment for the patient;   providing an external storage unit separate from the device, wherein the external storage unit contains stored information including the at least one threshold value of at least one analyte to be sensed by the device selected by the prescribing physician or the drug company;   reading the stored information stored on the external storage unit into a reader assembly associated with the device;   setting the device with the at least one threshold value for the at least one analyte to be sensed by the device with the information read by the reader assembly from the external storage unit,   wherein the at least one threshold value is a value such that a sensed analyte level beyond the value will cause a display to display an alert;   sensing the analyte level; and   displaying an alert if the sensed analyte level is beyond the threshold value.   
     
     
         31 . The method of  claim 30 , wherein the external storage unit is provided to be operatively associated with a drug-containing unit. 
     
     
         32 . The method of  claim 30  or  31 , wherein the reader assembly is a bar code reader and the external storage unit is associated with a bar code. 
     
     
         33 . The method of  claim 30  or  31 , wherein the reader assembly is an electromagnetic signal reader and the external storage unit is associated with an electromagnetic signal. 
     
     
         34 . The method of  claim 33 , wherein the drug is provided in a closed drug-containing unit and the method further comprises opening the drug-containing unit and detecting said electromagnetic signal upon opening the drug-containing unit. 
     
     
         35 . The method of  claim 30  or  31 , wherein the reader assembly is a magnetic signal reader and the external storage unit is associated with a magnetic signal. 
     
     
         36 . The method of  claim 30 , wherein the at least one threshold value of the at least one analyte to be sensed by the device is selected by a prescribing physician for the patient or for a class of patients. 
     
     
         37 . The method of  claim 30 , wherein the at least one threshold value of the at least one analyte to be sensed by the device is selected by a drug company for the patient or for a class of patients. 
     
     
         38 . A system for monitoring a patient, comprising a device and an external storage unit provided separately from the device and containing stored information set by a prescribing physician or a drug company and including at least one threshold value of at least one analyte to be sensed by the device, the at least one threshold value of the at least one analyte being associated with a particular drug being or to be taken by the patient or course of treatment for the patient, wherein the device comprises:
 a sensor for sensing at least one analyte in a patient;   a display for displaying processed information concerning the sensed analyte;   a reader assembly for reading information from the external storage unit; and   a processor configured for setting the device with the at least one threshold value for the at least one analyte to be sensed in accordance with the information read by the reader assembly from the external storage unit, and configured for processing the information concerning the analyte and configured for sending the processed information to the display, wherein the at least one threshold value is a value such that a sensed analyte level beyond the value will cause the display to display an alert.   
     
     
         39 . The system of  claim 38 , wherein the reader assembly is a bar code reader. 
     
     
         40 . The system of  claim 38 , wherein the reader assembly is an electromagnetic signal reader. 
     
     
         41 . The system of  claim 38 , wherein the reader assembly is a magnetic signal reader. 
     
     
         42 . The system of  claim 38 , wherein the display is provided proximate the sensor. 
     
     
         43 . The system of  claim 38 , wherein the external storage unit is provided to be operatively associated with a drug-containing unit. 
     
     
         44 . The system of  claim 38 , wherein the reader assembly is a bar code reader and the external storage unit is associated with a bar code. 
     
     
         45 . The system of  claim 38 , wherein the reader assembly is an electromagnetic signal reader and the external storage unit is associated with an electromagnetic signal. 
     
     
         46 . The system of  claim 38 , wherein the reader assembly is a magnetic signal reader and the external storage unit is associated with a magnetic signal. 
     
     
         47 . The system of  claim 38 , wherein the at least one threshold value of the at least one analyte to be sensed by the device is selected by a prescribing physician for the patient or for a class of patients. 
     
     
         48 . The system of  claim 38 , wherein the at least one threshold value of the at least one analyte to be sensed by the device is selected by a drug company for the patient or for a class of patients. 
     
     
         49 . A method for programming a device capable of analyzing a bodily fluid, comprising:
 selecting by a patient's healthcare provider or a company sponsoring a drug study at least one action threshold value of at least one analyte to be sensed by the device, the at least one action threshold value of the at least one analyte being associated with a particular drug being or to be taken by the patient or course of treatment for the patient;   providing an external storage unit separate from the device, wherein the external storage unit contains stored information including the at least one action threshold value of at least one analyte to be sensed by the device selected by the patient's healthcare provider or the company sponsoring the drug study;   reading the stored information stored on the external storage unit into a reader assembly associated with the device;   setting the device with the at least one action threshold value for the at least one analyte to be sensed by the device with the information read by the reader assembly from the external storage unit, wherein the at least one action threshold value is a value such that a sensed analyte level beyond the value will cause a display to display an alert;   sensing the analyte level; and   displaying an alert if the sensed analyte level is beyond the action threshold value.   
     
     
         50 . The method of  claim 30  or  49 , wherein the external storage unit contains at least one threshold value associated with a drug-containing unit. 
     
     
         51 . The method of  claim 49 , wherein the at least one action threshold value of the at least one analyte to be sensed by the device is selected by a healthcare provider for the patient or for a patient class. 
     
     
         52 . The method of  claim 49 , wherein the at least one action threshold value of the at least one analyte to be sensed by the device is selected by a company sponsoring a drug study for the patient or for a patient class. 
     
     
         53 . A system for monitoring a patient, comprising a device and an external storage unit provided separately from the device and containing stored information set by a patient's healthcare provider or a company sponsoring a drug study and including at least one action threshold value of at least one analyte to be sensed by the device, the at least one action threshold value of the at least one analyte being associated with a particular drug being or to be taken by the patient or course of treatment for the patient, wherein the device comprises:
 a sensor for sensing at least one analyte in a patient;   a display for displaying processed information concerning the sensed analyte;   a reader assembly for obtaining information from the external storage unit; and   a processor configured for setting the device with the at least one action threshold value for the at least one analyte to be sensed in accordance with the information read by the reader assembly from the external storage unit, and configured for processing the information concerning the analyte and configured for sending the processed information to the display, wherein the at least one action threshold value is a value such that a sensed analyte level beyond the value will cause the display to display an alert.   
     
     
         54 . The system of  claim 53 , wherein the reader assembly is a bar code reader. 
     
     
         55 . The system of  claim 53 , wherein the display is provided proximate the sensor. 
     
     
         56 . The system of  claim 53 , wherein the at least one action threshold value of the at least one analyte to be sensed by the device is selected by a healthcare provider for the patient or for a patient class. 
     
     
         57 . The system of  claim 53 , wherein the at least one action threshold value of the at least one analyte to be sensed by the device is selected by a company sponsoring a drug study for the patient or for a patient class.