System and method for the electrochemical measurement of an analyte employing a remote sensor

• US 8,394,246 B2
• Filed: 08/03/2009
• Issued: 03/12/2013
• Est. Priority Date: 02/23/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Celentano, Michael J., Walling, P. Douglas
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US12/534,177
• Publication Number:
  US 20100213080A1
• Time in Patent Office: 1,317 Days
• Field of Search: 20440301-40315, 205/777.5, 205/778, 205/792, 422 8201- 8203
• US Class Current: 204/403.02
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C
• CPC Class Codes: G06K 19/0717 the sensor being capable of sensing environmental conditions such as temperature history or pressure

Abstract

A remote measurement system measures the concentrations of analytes in fluid samples. The system includes a metering device that can receive signals from a test strip or alternatively interrogate the test strip to obtain information. The test strip includes an area for receiving a fluid sample and electrochemically producing a current response that is sensed within the fluid sample. The test strip also includes an antenna and a radio frequency signal circuit for transmitting a signal indicative of the current response of a fluid sample to be analyzed. The metering device receives the signal and can convert it into a readable display in some embodiments. Remote electrochemical analysis of a fluid sample is thereby obtained.

Claims

1. A disposable test element comprising:

an electrochemical biosensor adapted to react a sample of a patient'"'"'s blood with one or more reagents and to sense an electrical characteristic of the sample during the reaction with the disposable test element not being connected to any metering device, and circuitry operable to receive a wireless input signal from a remote monitor, the wireless input signal including clocking information, the circuitry further operable to utilize the clocking information from the wireless signal in combination with a circuit including the sample to provide clocked output of information indicative of a patient'"'"'s blood glucose and sample quantity information, and provide a wireless signal including the clocked output receivable by the remote monitor with the disposable test element not being connected to any metering device.

2. A method comprising:

providing a sample of biological fluid to a disposable biosensor;

reacting the sample with a reagent in the biosensor;

sensing a current characteristic of the sample during the reacting;

receiving a wireless input signal from a remote monitor, the wireless input signal including timing information;

utilizing the timing information to provide output including sample characteristic information and sample quantity information;

outputting a wireless output signal including the timed output receivable by the remote monitor;

receiving and storing the output information at the remote monitor;

transferring the received and stored information from the remote monitor to a processing unit; and

determining blood glucose information at the remote monitor or the processing unit or both;

wherein said acts of providing, reacting, sensing, receiving, utilizing, and outputting occur with the disposable biosensor not being physically connected to a metering device.

3. A system comprising:

a metering device, an in vitro test strip, and a remote intermediate device, the remote intermediate device comprising circuitry operable to wirelessly send and receive signals to and from the test strip;

the test strip comprising circuitry operable to wirelessly send and receive signals to and from the remote intermediate device and a reaction zone for receiving a fluid sample and performing an electrochemical reaction;

wherein the test strip is configured to apply a potential to the reaction zone when a sample is received in the reaction zone, to obtain an electrochemical response of the reaction zone to the potential, and to generate and transmit a first signal corresponding to the electrochemical response to the remote intermediate device; and

wherein the remote intermediate device is configured to receive the first signal from the test strip and provide said first signal to a processing circuitry configured to calculate a concentration of an analyte in the fluid sample based at least in part on said first signal, the processing circuitry being provided on one of the remote intermediate device and the metering device;

the metering device comprising a display and circuitry operable to send and receive signals to and from the remote intermediate device, wherein the remote intermediate device is configured to transfer to the metering device one or both of the first signal or second signals having information relating to the calculated concentration of the analyte, the metering device being configured to display the calculated concentration on the display.

4. The system according to claim 3 wherein the remote intermediate device is further configured to provide at least one of a clock signal, an activation signal, and a power signal to the test strip.

5. The system according to claim 3 wherein the response to the potential is a current response.

6. The system according to claim 3 wherein the remote intermediate device is a user-portable storage unit operable to store encoded information received from the test strip and further comprising a processing unit operable to receive the stored information from the user-portable storage unit and to process the information to provide information of a patient'"'"'s blood glucose.

7. The system according to claim 3 wherein the test strip comprises a clock circuit or receives a clocking signal from the remote intermediate device, and the signal corresponding to the response of the reaction zone to the potential comprises a current response as a function of time.

8. The system according to claim 3 wherein the test strip is further configured to detect sufficient sample fluid application to the reaction zone.

9. The system according to claim 3 wherein the intermediate device is configured to receive a plurality of signals corresponding to respective electrochemical responses from a plurality of test strips and provide each of said plurality of signals to the processing circuitry to calculate a concentration of an analyte in the fluid sample from a particular one of said test strips, the metering device being configured to store each of the calculated concentrations.

10. The system of claim 9 wherein the metering device is configured to download a plurality of measurement information from the remote intermediate device.

11. The system of claim 3 wherein the intermediate device comprises one of a fob, a watch, and a pen device.

12. The system of claim 3 wherein the metering device comprises a carrier having a docking location configured to receive the remote intermediate device, the processing circuitry being provided on the carrier, wherein the remote intermediate device is configured to be plugged into the carrier and to transfer to the carrier a plurality of signals corresponding to respective electrochemical responses, the carrier transferring the plurality of signals to the processing circuitry for calculating analyte concentrations for a plurality of fluid samples.

13. A method comprising:

(a) providing a sample fluid to a reaction zone of a test strip;

(b) reacting the sample fluid with a reagent in the reaction zone;

(c) applying a potential to the sample fluid in the reaction zone;

(d) activating a clock for generating a timing signal corresponding to the potential;

(e) measuring a current response of the sample during the reacting;

(f) converting the current response and timing signal into an analog or digital signal;

(g) wirelessly transmitting the analog or digital signal to a remote intermediate device;

(h) providing the analog or digital signal to a processing circuitry configured to determine concentration of an analyte, the processing circuitry being provided on one of the remote intermediate device and a metering device;

(i) using at least the analog or digital signal, determining the concentration of an analyte of the sample fluid; and

(j) displaying the concentration on a display of the metering device.

14. The method according to claim 13 further comprising receiving and storing the analog or digital signal at the remote intermediate device.

15. The method according to claim 14 further comprising transferring the received and stored analog or digital signal to a processing unit.

16. The method according to claim 13 wherein the sample fluid is blood and the analyte is glucose.

17. The method according to claim 13 wherein the reagent includes glucose oxidase.

18. The method according to claim 13 wherein the analog or digital signal includes dosage sufficiency information.

19. The method according to claim 13 wherein the analog or digital signal includes Cottrell failsafe ratio information.

20. The method according to claim 13 wherein the analog or digital signal includes Cottrell current measurement information.

21. The method according to claim 13 wherein the processing circuitry is provided on the metering device, the metering device comprising a carrier having a docking location configured to receive the remote intermediate device, the method further comprising repeating steps (a) through (g) for a plurality of test strips and sample fluids, downloading from the intermediate device to the metering device the plurality of analog or digital signals, providing the plurality of analog or digital signals to the processing circuitry, and determining the concentration of an analyte of each of the plurality of sample fluids using at least the corresponding analog or digital signal.