Limited-use blood glucose meters

• US 8,658,108 B2
• Filed: 09/01/2010
• Issued: 02/25/2014
• Est. Priority Date: 09/01/2010
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Sauers, Matthew C., Davies, Robert G., Csavas, Colleen, Batman, Carol J., Rutkowski, Paul S., Gardner, Randy J., Blackburn, Michael J., Cadio, Michel A.
• Primary Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US12/873,697
• Publication Number:
  US 20120053436A1
• Time in Patent Office: 1,273 Days
• Field of Search: 422/404, 422/500, 422/68.1
• US Class Current: 422/404
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2560/028 Arrangements to prevent overuse, e.g. by counting the number of uses
• CPC Class Codes: A61B 2560/04 Constructional details of apparatus
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
• CPC Class Codes: G09G 2300/0473 Use of light emitting or modulating elements having two or more stable states when no power is applied
• CPC Class Codes: G09G 2380/08 Biomedical applications
• CPC Class Codes: G09G 3/16 by control of light from an independent source
• CPC Class Codes: G09G 3/344 based on particles moving in a fluid or in a gas, e.g. electrophoretic devices electrophoretic devices per se G02F1/167

Abstract

A limited-use blood glucose meter includes a printed circuit board assembly that includes a power source, a strip port, a strip reading device, a controller device, a bi-stable display, and a display controller. The strip reading measures a reaction between a blood sample present on the blood glucose test strip and the blood glucose reagent, generates a blood glucose signal, and calculates a blood glucose level. The controller device receives the blood glucose level from the strip reading device. The controller device provides display instructions to the display controller and the display controller provides drive voltages to the bi-stable segments such that the bi-stable segments persistently display the most-recent blood glucose level. The strip reading device performs a predetermined number of blood glucose tests and calculates a blood glucose level only for blood glucose strips associated with the disposable blood glucose meter.

Claims

1. A low-cost, limited-use blood glucose meter that is programmed or otherwise configured to only perform a predetermined number of blood glucose measurement tests that equals the number of blood glucose test strips associated with the limited-use blood glucose meter and originally contained in a package, comprising:

a meter housing;

a printed circuit board assembly, the printed circuit board assembly comprising;

a power source comprising a non-removable battery mounted on a side of the printed circuit board assembly that is sealed within the meter housing and which is inaccessible to the user and cannot be removed from the limited-use blood glucose meter without causing damage to the meter housing or the printed circuit board;

a strip port which accepts a blood glucose test strip having a blood glucose reagent;

a strip reading device electrically coupled to the strip port which measures a reaction between a blood sample present on the blood glucose test strip and the blood glucose reagent, generates a blood glucose signal corresponding with the measured reaction, and which calculates a blood glucose level based at least in part on the blood glucose signal;

a controller device communicatively coupled to the strip reading device, wherein the controller device receives the blood glucose level from the strip reading device;

a bi-stable display comprising a plurality of bi-stable segments which transition between an on-state and an off-state with the application of drive voltages, wherein the bi-stable segments are arranged to display the blood glucose level, and wherein the bi-stable display persistently displays a most-recent blood glucose level without power provided by the power source; and

a display controller communicatively coupled to the controller device and the bi-stable display, wherein the controller device provides display instructions to the display controller and the display controller provides drive voltages to the bi-stable segments based on the blood glucose level such that the bi-stable segments persistently display the most-recent blood glucose level; and

wherein the strip reading device performs the predetermined number of blood glucose measurement tests and calculates the blood glucose level, and once the predetermined number of blood glucose measurement tests have been performed, the controller device of the limited-use blood glucose meter is programmed to cease all functions.

2. The limited-use blood glucose meter according to claim 1, further comprising the meter housing defining an enclosure in which the printed circuit board assembly is disposed such that the bi-stable display is aligned with the lens, the lens being dimensioned such that the bi-stable display is visible through the lens;

and

the strip port opening is aligned with the strip port and sized to accept the blood glucose test strip.

3. The limited-use blood glucose meter according to claim 2, wherein the meter housing further comprises a blood glucose test strip enclosure to store the blood glucose test strips associated with the limited-use blood glucose meter.

4. The limited-use blood glucose meter according to claim 3, wherein:

the controller device detects when the blood glucose test strip enclosure is opened for a first time and initiates a timer; and

expiration of the timer causes all the functions of the limited-use blood glucose meter to cease such that operational functions of the limited-use blood glucose meter is prevented.

5. The limited-use blood glucose meter according to claim 1, wherein the bi-stable display persistently displays the most-recent blood glucose level until a subsequent blood glucose level is calculated.

6. The limited-use blood glucose meter according to claim 1, wherein the bi-stable display comprises an e-paper display.

7. The limited-use blood glucose meter according to claim 1, wherein:

the bi-stable display comprises a good blood glucose symbol and a bad blood glucose symbol;

the good blood glucose symbol is activated when the most-recent blood glucose level is within a good blood glucose level range; and

the bad blood glucose symbol is activated when the most-recent blood glucose level is not within the good blood glucose level range.

8. The limited-use blood glucose meter according to claim 1, further comprises a timer, wherein expiration of the timer causes all the functions of the limited-use blood glucose meter to cease such that operational functions of the limited-use blood glucose meter is prevented.

9. The limited-use blood glucose meter according to claim 1, further comprising a memory device, wherein the memory device stores a code value that corresponds to a lot code of the blood glucose test strips.

10. The limited-use blood glucose meter according to claim 1, wherein the number of blood glucose measurement tests is limited by software.

11. The limited-use blood glucose meter according to claim 1, wherein the limited-use blood glucose meter is programmed to operate with a selected one of a plurality of test strip types.

12. The limited-use blood glucose meter according to claim 1, wherein the limited-use blood glucose meter is powered on when the blood glucose test strip is inserted into the strip port and is automatically powered down after a predetermined time following the display controller providing drive voltages to the bi-stable display.

13. The limited-use blood glucose meter according to claim 1, further comprising a memory device communicatively coupled to the strip reading device and the controller device, wherein:

the strip reading device writes the most-recent blood glucose level to the memory device; and

the controller device instructs the display controller to read the memory device to obtain the most-recent blood glucose level and provide the drive voltages to the bi-stable display.

19. The limited-use blood glucose meter according to claim 8, wherein the expiration of a duration of time that corresponds to a lifetime of a blood glucose strip exposed to ambient air causes all the functions of the limited-use blood glucose meter to cease.

14. A low-cost, limited-use blood glucose meter that is programmed or otherwise configured to only perform for a user a predetermined number of blood glucose measurement tests that equals the number of blood glucose test strips associated with the limited-use blood glucose meter and originally contained in a package, comprising a housing and a printed circuit board assembly, the printed circuit board assembly provided in the housing comprising:

a non-removable battery mounted on a side of the printed circuit board assembly that is sealed within the housing and which is inaccessible to the user and cannot be removed from the limited-use blood glucose meter without causing damage to the housing or the printed circuit board;

a strip port which accepts a blood glucose test strip having a blood glucose reagent;

a strip reading device electrically coupled to the strip port which measures a reaction between a blood sample present on the blood glucose test strip and the blood glucose reagent, generates a blood glucose signal corresponding with the measured reaction, and which calculates a blood glucose level based at least in part on the blood glucose signal;

a controller device communicatively coupled to the strip reading device, wherein the controller device receives the blood glucose level from the strip reading device;

a bi-stable display comprising a plurality of bi-stable segments which transition between an on-state and an off-state with the application of drive voltages, wherein the bi-stable segments are arranged to display the blood glucose level, and wherein the bi-stable display persistently displays a most-recent blood glucose level without power provided by the non-removable battery until a subsequent blood glucose level is calculated; and

a display controller communicatively coupled to the bi-stable display, wherein the display controller receives display instructions regarding the blood glucose level from the controller device and provides drive voltages to the bi-stable segments based on the blood glucose level such that the bi-stable segments persistently display the most-recent blood glucose level; and

wherein the strip reading device performs the predetermined number of blood glucose measurement tests and calculates the blood glucose level, and once the predetermined number of blood glucose measurement tests have been performed, the controller device of the limited-use blood glucose meter is programmed to cease all functions.

15. The limited-use blood glucose meter according to claim 14, the housing comprising a blood glucose test strip enclosure to store blood glucose test strips associated with the limited-use blood glucose meter.

16. The limited-use blood glucose meter according to claim 15, wherein:

the controller device detects when the enclosure is opened for a first time and initiates a timer; and

expiration of the timer causes all the functions of the limited-use blood glucose meter to cease such that operational functions of the limited-use blood glucose meter is prevented.

17. A low-cost, limited-use blood glucose meter that is programmed or otherwise configured to only perform for a user a predetermined number of blood glucose measurement tests that equals the number of blood glucose test strips associated with the limited-use blood glucose meter and originally contained in a package, comprising:

a meter housing; and

a printed circuit board assembly provided in the meter housing and consisting essentially of;

a non-removable battery mounted on a side of the printed circuit board assembly that is sealed within the meter housing and which is inaccessible to the user and cannot be removed from the limited-use blood glucose meter without causing damage to the meter housing or the printed circuit board;

a strip port which accepts a blood glucose test strip having a blood glucose reagent;

a strip reading device electrically coupled to the strip port which measures a reaction between a blood sample present on the blood glucose test strip and the blood glucose reagent, generates a blood glucose signal corresponding with the measured reaction, and which calculates a blood glucose level based at least in part on the blood glucose signal;

a controller device communicatively coupled to the strip reading device, wherein the controller device receives the blood glucose level from the strip reading device;

a bi-stable display comprising a plurality of bi-stable segments which transition between an on-state and an off-state with the application of drive voltages, wherein the bi-stable segments are arranged to display the blood glucose level, and wherein the bi-stable display persistently displays a most-recent blood glucose level without power provided by the non-removable battery;

a display controller communicatively coupled to the controller device and the bi-stable display which provides drive voltages to the bi-stable segments based on the blood glucose level such that the bi-stable segments persistently display the most-recent blood glucose level; and

a memory device communicatively coupled to the strip reading device and the controller device, wherein the memory device stores the most-recent blood glucose level, and the display controller retrieves the most-recent blood glucose level from the memory device upon instruction from the controller device, and

wherein the meter housing comprising a lens and a strip port opening, wherein;

the meter housing defines an enclosure in which the printed circuit board assembly is disposed such that the bi-stable display is aligned with the lens, the lens being dimensioned such that the bi-stable display is visible through the lens; and

the strip port opening is aligned with the strip port and sized to accept the blood glucose test strip, and

wherein the strip reading device performs the predetermined number of blood glucose measurement tests and once the predetermined number of blood glucose measurement tests have been performed, the controller device of the limited-use blood glucose meter is programmed to cease all functions.

18. The limited-use blood glucose meter according to claim 17, wherein the non-removable battery ceases to operate after a predetermined time that corresponds with an expiration date of the limited-use blood glucose meter.