Disposable analytical microprocessor device

• US 10,132,820 B2
• Filed: 08/29/2008
• Issued: 11/20/2018
• Est. Priority Date: 09/01/2007
• Status: Active Grant

• Current Assignee: LifeAssays AB
• Original Assignee: LifeAssays AB
• Inventors: Kriz, Dario, Kriz, Kirstin Ann
• Primary Examiner(s): Sasaki, Shogo
• Application Number:
  US12/201,898
• Publication Number:
  US 20090061418A1
• Time in Patent Office: 3,735 Days
• Field of Search: 702 19- 23, 702 30- 32, 422502, 700266
• 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 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: G01N 2035/00683 of detectors
• CPC Class Codes: G01N 2035/00811 consumable or exchangeable components other than sample carriers, e.g. detectors, flow cells
• CPC Class Codes: G01N 2035/00851 process control parameters
• 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: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

The present invention generally relates to the determination of an analyte concentration (quantitative determination) or whether an analyte threshold level has been passed (qualitative determination) in a biological sample through employment of a disposable analytical microprocessor device. The device can include a batch-specific, self-executable algorithm for the calculation of the analyte concentration.

Claims

1. A disposable analytical microprocessor device for use with a sensing meter and a batch of disposable consumables

wherein said disposable analytical microprocessor device comprises a microprocessor and memory, said memory comprising at least one stored batch-specific disposable consumable parameter value and at least one self-executable algorithm,

wherein said analytical microprocessor device is capable of reversible engagement and bi-directional data transfer with said sensing meter,

wherein said analytical microprocessor device is configured for calculating an analyte concentration value using data received from the sensing meter in combination with mathematical approximation formulas comprised in said stored batch-specific disposable consumable parameter value, and transferring the analyte concentration value to said sensing meter.

2. The device of claim 1 wherein said device comprises a one-chip microcomputer which comprises said microprocessor.

3. The device of claim 1 wherein said reversible engagement enables serial or parallel bidirectional data transfer, or a combination thereof.

4. The device of claim 1 wherein said reversible engagement provides electrical connectivity and further provides said microprocessor with a clock pulse from an oscillator in said sensing meter.

5. The device of claim 1 wherein said reversible engagement is optical and enables serial or parallel bidirectional data transfer, or a combination thereof.

6. The device of claim 1 wherein said self-executable algorithm is based on a reference table conversion, or on a mathematical function approximation wherein said mathematical function is selected from the group comprised of:

a linear function, a polynomial function, a logarithmic function, an exponential function, and a trigonometric function.

7. The device of claim 1 wherein said memory is comprised within a one-chip microcomputer comprised in said disposable analytical microprocessor device or within a separate RAM, ROM, EPROM, or EEPROM-based memory chip comprised in said disposable analytical microprocessor device.

8. The device of claim 1 wherein said stored batch-specific disposable consumable parameter values are comprised of information relating to at least one parameter chosen from the group comprised of:

specific analyte calculation performance of said batch of disposable consumables, mathematical approximation formulas, encryption keys, analyte name in ASCI-code, a production batch number, a batch production date, a batch expiration date, a number of measurements allowed, analyte identification data, dates of using said disposable consumables, a remaining number of disposable consumables in the batch, an individual identification number of said sensing meter, an individual identification of a person operating said sensing meter, measuring or timing protocols, and high-low alarm level analyte concentration values.

9. The device of claim 8 wherein said stored batch-specific disposable consumable parameter values further include an encrypted key for secure data transfer between said microprocessor and said sensing meter.

10. The device of claim 1 wherein said device further includes a battery powered electronic date chip containing a real-time clock and a calendar which provides internal time and date information to said self-executable algorithm.

11. The device of claim 9,

wherein said self-executable algorithm is configured to detect a condition selected from the following group:

said stored batch-specific disposable consumer parameter values or said data show that a predetermined number of used disposable consumables has been exceeded;

the batch expiration has been exceeded;

the individual identification number of said sensing meter has been changed;

the encrypted key does not corresponds to an encrypted key in said sensing meter; and

a measuring procedure error has been reported from said sensing meter, and

wherein said self-executable algorithm is configured to disable execution by changing from an active operating state to a non-active operation state upon detection of said condition.

12. A system for use with a disposable consumable for quantitative and qualitative determination of analytes in a biological sample, wherein the system is comprised of the device of claim 1 and a sensing meter.

13. The system of claim 12 wherein said sensing meter further includes means for measuring magnetic permeability changes in said disposable consumable and wherein said sensing meter is operatively coupled to said microprocessor to provide for measurements indicative of manifestations of a chemical or physical reaction in said disposable consumable.

14. The system of claim 12 wherein the said sensing meter further includes means for measuring optical changes in said disposable consumable, and

wherein said sensing meter is operatively coupled to said microprocessor to provide for measurements indicative of manifestations of a chemical or physical reaction in said disposable consumable.

15. The system of claim 12 wherein said sensing meter further includes means for measuring electrochemical changes in said disposable consumable, and

wherein said sensing meter is operatively coupled to said microprocessor to provide for measurements indicative of manifestations of a chemical or physical reaction in said disposable consumable.

16. The system of claim 12 wherein said sensing meter further includes means for measuring mass changes in said disposable consumable, and

wherein said sensing meter is operatively coupled to said microprocessor to provide for measurements indicative of manifestations of a chemical or physical reaction in said disposable consumable.

17. The system of claim 12 wherein said sensing meter further includes sense means for measuring piezoelectric changes or surface plasmon effects in said disposable consumable, and

wherein said sensing meter is operatively coupled to said microprocessor to provide for measurements indicative of manifestations of a chemical or physical reaction in said disposable consumable.

18. The system of claim 12 wherein said sensing meter is configured for measuring any of the analytes glucose, albumin, hemoglobin (Hb and HbAl C), myoglobin, troponin (I and T), CK-MB, creatinine kinase (CK), d-dimer, P-type natriuretic peptide (BNP and pro BNP), n-terminal prohormone peptide (NT-proBNP), C-reactive protein (hsCRP and CRP), cystatin C, prothrombin, activated partial thromboplastin (APTT), HCG, LH, FSH, PSA, TSH, T3, T4, AFP, CEA, low density lipoprotein (LDL), High density lipoprotein (HDL), triglycerides, cholesterol, antibodies, Streptococcus A, Helicobacter Pylori, Salmonella, Chlamydia, Giardia, cholera, hepatitis (A, B and C), adenovirus, rotavirus or any combination thereof with said disposable consumable, and

wherein said sensing meter is operatively coupled to said disposable analytical microprocessor device to provide for measurements indicative of manifestations of a chemical or physical reaction in said disposable consumable.

19. The system of claim 12 wherein the said sensing meter further includes an electronic date chip containing a real-time clock and a calendar which provides time and date information to said self-executable algorithm.

20. A method for determining an analyte concentration in a biological sample, such method comprising;

a) applying a biological sample to a disposable analytical microprocessor device of claim 1; and

b) introducing said disposable analytical microprocessor device to the sensing meter of claim 12.