Self contained in-vitro diagnostic device

• US 9,851,360 B2
• Filed: 03/14/2014
• Issued: 12/26/2017
• Est. Priority Date: 03/22/2010
• Status: Active Grant

• Current Assignee: Impak Health LLC
• Original Assignee: Impak Health LLC
• Inventors: Inciardi, Salvatore Richard, Elliott, Sandra D., Tiren, Jonas Sven-Erik, Nathanaelson, Per, Ehrensvard, Jakob
• Primary Examiner(s): LUDLOW, JAN M
• Application Number:
  US14/212,219
• Publication Number:
  US 20140220666A1
• Time in Patent Office: 1,383 Days
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 2562/18 Shielding or protection of sensors from environmental influences, e.g. protection from mechanical damage
• 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: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A portable apparatus for measuring a glucose level of a user having: a card-like member; a processor within the card-like member; at least one glucose sensor comprising a reagent, the glucose sensor generating a signal indicative of a measured glucose level upon application of a blood sample to the glucose sensor, wherein the glucose sensor is fixed to the card-like member and operably coupled to the processor; and at least one cover alterable between a first position in which the glucose sensor is covered and a second position in which the glucose sensor is exposed for use.

Claims

1. A portable apparatus for measuring a glucose level of a user comprising:

a thin, generally flat substrate housing member having opposing substantially planar surfaces;

a processor disposed within said housing member;

at least one test site comprising a glucose sensor for generating a signal indicative of a measured glucose level upon application of a blood sample to the glucose sensor, wherein the glucose sensor comprises a cavity fixed to said housing member and operably coupled to the processor and wherein the reagent is substantially within said cavity;

a calibration glucose sensor fixed to the housing member so as to be unusable by the user and wherein calibration data unique to the at least one glucose sensor is generated by the calibration glucose sensor; and

at least one cover alterable between a first position in which the glucose sensor is covered and a second position in which the glucose sensor is exposed for use.

2. The apparatus of claim 1 wherein the processor receives the signal indicative of the measured glucose level from the glucose sensor and calculates an actual glucose level based on the received signal, the apparatus further comprising a memory device operably coupled to the processor, the processor storing the actual glucose level within the memory device.

3. The apparatus of claim 2 further comprising an indicator configured to indicate whether the actual glucose level calculated by the processor indicates a glucose level within a healthy glucose level, an unhealthy glucose level, or an inconclusive glucose level.

4. The apparatus of claim 1 further comprising an indicator fixed to the housing member and operably coupled to the processor to provide an indication to the user of:

(1) whether the at least one glucose sensor has been previously used;

(2) whether the at least one glucose sensor has received a sufficient amount of the blood sample;

(3) whether the at least one glucose sensor registered an accurate measurement; and

/or (4) whether the at least one glucose sensor registered an inaccurate measurement.

5. The apparatus of claim 1 further comprising a memory device within the housing member and operably coupled to the processor, the memory device comprising pre-stored calibration data unique to the at least one glucose sensor.

6. The apparatus of claim 5 wherein the calibration glucose sensor being is from the same lot as the at least one glucose sensor, and further wherein the pre-stored calibration data unique to the glucose sensor is generated by the calibration glucose sensor and stored in the memory device.

7. The apparatus of claim 6 wherein the calibration glucose sensor is embedded within the housing member.

8. The apparatus of claim 6 wherein the calibration data unique to the glucose sensor is generated by the calibration glucose sensor by:

applying a test solution having a known glucose level to the calibration glucose sensor, the calibration glucose sensor generating a test signal indicative of a measured glucose level of the test solution; and

the microprocessor receiving the test signal and generating the pre-stored calibration data for storage on the memory device.

9. The apparatus of claim 1 further comprising a temperature sensor operably configured to measure ambient temperature and/or temperature of the at least one glucose sensor and generate a temperature signal indicative of the measured ambient temperature and/or temperature of the glucose sensor, the temperature sensor operably coupled to the microprocessor.

10. The apparatus of claim 9 further comprising an indicator configured to indicate whether the ambient temperature and/or temperature of the at least one glucose sensor is above a threshold value.

11. The apparatus of claim 1 further comprising a protective seal sealing the at least one glucose sensor, the protective seal disposed between the at least one glucose sensor and the cover.

12. The apparatus of claim 1 further comprising a wireless communication device operably coupled to the processor and configured to transmit a transmission signal generated by the processor to an external device.

13. The apparatus of claim 12, wherein the wireless communication device is a passive, semi-passive or active RFID or a wireless local area networking enabled device.

14. The apparatus of claim 12 wherein the processor receives the signal indicative of the measured glucose level from the at least one glucose sensor and calculates an actual glucose level based on the received signal, the apparatus further comprising a memory device operably coupled to the processor, the processor storing the actual glucose level within the memory device, and wherein the transmission signal is indicative of the actual glucose level.

15. The apparatus of claim 1 wherein the reagent is glucose oxidase, glucose dehydrogenase/pyrroloquinolinequinone, dehydrogenase/nicotinamide-adenine dinucleotide, or dehydrogenase/flavin-adenine dinucleotide.

16. A portable apparatus for measuring a physiological condition comprising:

a planar design comprising a thin, generally flat housing member having opposing substantially planar surfaces;

a processor integrally formed within the housing member;

at least one physiological parameter sensor for generating a signal indicative of a measured physiological parameter upon application of a blood sample to the sensor, wherein said physiological parameter sensor comprises a cavity fixed to said housing member and a reagent and further wherein said physiological parameter sensor is operably coupled to the processor and wherein the reagent is substantially within said cavity

a calibration physiological parameter sensor fixed to the housing member so as to be unusable by the user and wherein calibration data unique to the at least one sensor is generated by the calibration physiological parameter sensor and wherein the physiological parameter sensor is configured in the same level and on the same substrate that holds the calibration physiological parameter sensor and

at least one cover alterable between a first position in which the sensor is covered and a second position in which the sensor is exposed for use.

17. The apparatus of claim 16 wherein the physiological parameter is a glucose level, cholesterol level, blood urea nitrogen (BUN) level and/or creatinine level.

18. The apparatus of claim 16 wherein the processor receives the signal indicative of the measured physiological parameter from the sensor and calculates an actual physiological level based on the received signal, the apparatus further comprising a memory device operably coupled to the processor, the processor storing the actual physiological level within the memory device.

19. The apparatus of claim 16 further comprising a memory device within the housing member and operably coupled to the processor, the memory device comprising pre-stored calibration data unique to the sensor.

20. The apparatus of claim 19 wherein the calibration physiological parameter sensor is embedded within the housing member.

21. The apparatus of claim 19 wherein the calibration data unique to the physiological parameter sensor is generated by the calibration physiological parameter sensor by:

applying a test solution having a known physiological level to the calibration physiological parameter sensor, the calibration physiological parameter sensor generating a test signal indicative of a measured physiological level of the test solution; and

the processor receiving the test signal and generating the pre-stored physiological parameter calibration data for storage on the memory device.

22. The apparatus of claim 16 further comprising a temperature sensor operably configured to measure ambient temperature or temperature of the at least one sensor and generate a temperature signal indicative of the measured ambient temperature or temperature of the at least one sensor, the temperature sensor operably coupled to the processor.

23. The apparatus of claim 22 further comprising an indicator configured to indicate whether the ambient temperature or temperature of the at least one sensor is above a threshold value.

24. The apparatus of claim 16 further comprising a protective seal sealing the at least one sensor, the protective seal disposed between the at least one sensor and the cover.

25. The apparatus of claim 16 further comprising a wireless communication device operably coupled to the processor and configured to transmit a transmission signal generated by the processor to an external device.

26. The apparatus of claim 25, wherein the wireless communication device is a passive, semi-passive or active RFID or a wireless local area networking enabled device.

27. The apparatus of claim 25 wherein the processor receives the signal indicative of the measured physiological level from the at least one sensor and calculates an actual physiological level based on the received signal, the apparatus further comprising a memory device operably coupled to the processor, the processor storing the actual physiological level within the memory device, and wherein the transmission signal is indicative of actual physiological level.