Point-of-care in-vitro blood analysis system

• US 6,845,327 B2
• Filed: 06/08/2001
• Issued: 01/18/2005
• Est. Priority Date: 06/08/2001
• Status: Expired due to Term

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Epocal Incorporated (Siemens AG)
• Inventors: Lauks, Imants R.
• Primary Examiner(s): Barlow, John
• Assistant Examiner(s): Lau, Tung S
• Application Number:
  US09/875,949
• Publication Number:
  US 20030148530A1
• Time in Patent Office: 1,320 Days
• Field of Search: 702/23, 600/453, 600/437, 600/18, 600/492, 600/322, 600/547, 600/455, 324/71, 324/103, 356/36, 356/601, 607/5, 607/60, 225/778, 436/63, 435/18, 367/135, 736/25, 73/54, 377/12, 377/10
• US Class Current: 702/23
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80

Abstract

Devices for cost-effectively performing in-vitro diagnostic chemical analyses at multiple distributed locations within a medical institution are disclosed. One object of this invention is to provide a network of distributed sensory devices that acquire sensor signals from blood specimens and deliver those signals through a connect on to a central location for analysis by a general-purpose computer and generation of an analysis result. The analysis result is then sent to numerous locations on a network for display, including also possibly back to the location of signal acquisition. Cost-effective mobile sensing devices are also disclosed. The present system includes blood-sensor signal acquisition devices distributed throughout the hospital. The sensory signal-acquisition devices are card readers that acquire raw sensory signals from diagnostic cards inserted therein. These diagnostic cards are smart card-like devices modified for blood collection that contain sensory elements such as electrodes adapted to provide a raw sensory signal. The signal acquisition devices are modified smart card readers, which acquire the raw sensory data from an inserted smart card through a standardized contact arrangement and provide the raw data to data processing devices such as data acquisition cards. The system includes multiple remote ports for acquiring blood sensor signals. One or more card reader, when connected to a mobile general-purpose computer, can be converted into a complete mobile blood analyzer.

Claims

1. A point-of-care blood measurement system for performing in-vitro diagnostic chemical analysis of a sample, comprising

a diagnostic card reader for receiving a raw sensory signal from a diagnostic card exposed to the sample and for providing an analog sensory signal directly related to the raw sensory signal, the raw sensory signal being dependant on a concentration of a chemical species in the sample,

a data acquisition circuit for converting the analog sensory signal into a digital sensory signal;

and

a general-purpose computer separate and distinct from the diagnostic card reader for receiving and analyzing the digital sensory signal and producing an analysis result output representative of the chemical species concentration in the sample.

2. The system of claim 1, wherein the diagnostic card reader is a smart-card reader and the diagnostic card is a modified smart card.

3. The system of claim 1, wherein the diagnostic card reader includes amplification means for amplifying the raw sensory signal, and sensor multiplexing means for generating an output including secondary signals in addition to the raw sensory signal.

4. The system of claim 1, wherein the general-purpose computer is a portable computer and the data acquisition circuit is a personal computer data acquisition card, or a personal computer memory card international association data acquisition card inserted into the computer.

5. The system of claim 1, wherein the general-purpose computer is a personal computer and the data acquisition circuit is a data acquisition card incorporated therein.

6. The system of claim 1, wherein the diagnostic card reader and the data acquisition circuit are incorporated In the same housing.

7. The system of claim 1, wherein the system includes a plurality of diagnostic card readers and the data acquisition circuit is a data acquisition card constructed for converting the respective analog sensory signal of each one of the plurality of diagnostic card readers.

8. The system of claim 1, wherein the system includes a plurality of diagnostic card readers and a data acquisition circuit for each diagnostic card reader and the separate computer is connectable to all data acquisition circuits.

9. The system of claim 1, wherein the diagnostic card reader and the data acquisition circuit are distributed components of the system and the computer is a remotely located central component, the system further including communication means for electrical or electronic communication of the digital signal to the computer.

10. The system of claim 1, wherein the conversion of the digital sensory signal into an analysis result output is carried out in the general-purpose computer by way of a data-calculation software operating thereon.

11. The system of claim 1, further including measurement control means for controlling measurement conditions in the diagnostic card, the measurement control means including heating means positioned in the diagnostic card reader for heating a diagnostic card inserted therein, and control software on the general-purpose computer for controlling operation of the heating means.

12. The system of claim 1, further comprising quality control means for monitoring the quality of the raw sensory signal, which quality control means is implemented as quality-control software running only on the computer.

13. The system of claim 11, wherein the computer is constructed for providing at least one digital control signal to the diagnostic card reader for controlling the operation of the heating means.

14. The system of claim 1, wherein the diagnostic card reader includes a means for generating an on/off signal to the data acquisition circuit and general-purpose computer.

15. The system of claim 1, wherein the diagnostic card reader is constructed for receiving the raw analog signal from one of a number of different diagnostic cards each specific for a different chemical species in the sample, the raw analog sensory signal depending on a concentration of the respective different chemical species in the sample.

16. The system of claim 7, wherein the computer is constructed to provide a single clock signal to all diagnostic card-readers by way of the data acquisition unit.

17. The system of claim 13, wherein the heating means in the card reader is constructed to heat a measurement region of a diagnostic card inserted therein.

18. The system of claim 14, wherein the means for generating the on/off signal is a mechanical switch in the diagnostic card reader which is normally in the off condition and is actuated upon insertion of a diagnostic card into the diagnostic card reader.

19. A point-of-care blood measurement system for performing in-vitro diagnostic chemical analysis of a sample, comprising

a diagnostic card reader for receiving a raw analog sensory signal from a single use blood diagnostic card exposed to the sample and for providing an analog output signal directly related to the raw sensory signal, the raw sensory signal being dependent on a concentration of a chemical species in the sample,

sensor multiplexing means for generating a secondary output signal in addition to the analog sensory signal;

a data acquisition circuit for converting the amplified analog sensory signal into a serial digital sensory signal; and

a general-purpose computer separate and distinct from the diagnostic card reader for receiving and analyzing the digital sensory signal and the secondary output signal and for producing an analysis result output representative of the chemical species concentration in the sample, the computer having an input port for connection to at least one data acquisition circuit.

20. A point-of-care blood measurement system for performing in-vitro diagnostic chemical analysis of a sample, comprising

a diagnostic card reader for receiving a raw analog sensory signal from a single use blood diagnostic card and for providing an analog sensory output signal directly related to the raw sensory signal, the raw sensory signal being dependent on a concentration of a chemical species in the sample, the diagnostic card and the card reader further including fluidics for control and/or supply of the sample fluid and other reagents or calibrants or other fluids required for the sensory analysis of the sample;

amplification means for amplifying the analog sensory output signal and sensor multiplexing means for generating an output including signals in addition to the analog sensory output signal;

a data acquisition circuit for converting the analog sensory output signal into a serial digital sensory signal, and a signal conversion circuit for converting the digital sensory signal of the data acquisition circuit to a radio frequency digital signal; and

a general-purpose computer for receiving and analyzing the radio frequency digital signal and producing an analysis result output representative of the chemical species concentration in the sample, the computer having a radio frequency receiver module for receiver module for receiving the radio frequency digital signal produced by the signal conversion means.

21. The system of claim 20, wherein the diagnostic card reader further includes a test circuit for quality control of the card reader and especially the interfacing thereof with the diagnostic card.

22. A card reader for use in a point-of-care blood measurement system for performing in-vitro diagnostic chemical analysis of a sample including a diagnostic card reader, a data acquisition circuit for converting an amplified analog sensory signal output by he card reader into a digital sensory signal, and a general-purpose computer separate and distinct from the diagnostic card reader for receiving and analyzing the digital sensory signal and producing an analysis result output, the card reader comprising:

a housing;

a connector for engaging a diagnostic card exposed to a sample and for receiving a raw sensory signal from the diagnostic card for providing an analog sensory signal directly related to the raw sensory signal, the raw sensory signal being dependent on a concentration of a chemical species in the sample;

a signal conversion circuit for converting the analog sensory signal into a digital sensory signal directly related to the raw sensory signal; and

a transmitter for wireless digital communication with the general-purpose computer for receiving the digital sensory signal from signal conversion circuit and transmitting the digital sensory signal to the computer.

23. The card reader of claim 22, wherein the diagnostic card is a modified smart card.

24. The card reader of claim 22, further comprising means for influencing the measurement conditions in a measuring region at an inserted diagnostic card, the means for influencing including a heating means for heating the measuring region and means for controlling the heating means, whereby the means for controlling is to located on the computer and the transmitter is a two way transmitter for transmitting the digital sensory signal to the computer and for receiving control signals from the computer for operation of the heating means.

25. The card reader of claim 23, further including fluidics for control and/or supply to the diagnostic card of the sample fluid and other reagents or calibrants or other fluids required for the sensory analysis of the sample.

26. The card reader of claim 23, wherein the diagnostic card and card reader are constructed to perform an optical measurement of the sample.

27. A card for use in a point-of-care blood measurement system for performing in-vitro diagnostic chemical analysis of a sample including a diagnostic card reader;

and a general-purpose computer separate and distinct from the diagnostic card reader for receiving and analyzing the digital sensory and producing an analysis result output, the car reader comprising;

a housing;

a connector for engaging a diagnostic card exposed to a sample and receiving a raw sensory signal from the diagnostic card for providing a analog sensory signal directly related to the raw sensory signal, the raw sensory signal being dependent on a concentration of a chemical species in the sample;

a signal conversion circuit for converting the analog sensory signal into a digital sensory signal directly related to the raw sensory signal;

and a transmitter for communication with the general-purpose computer, the transmitter being constructed for receiving the digital signal from the signal conversion circuit and producing a transmittable digital output signal for transmission to the computer through one of a wired connection and a wireless connection.

28. The card reader of claim 27, wherein the diagnostic card is a modified smart card.

29. The card reader of claim 28, further including fluidics for control and/or supply to the diagnostic card of the sample fluid and other reagents or calibrants or other fluids required for the sensory analysis of the sample.

30. The card reader of claim 27, further comprising means for influencing the measurement conditions in a measuring region of an inserted diagnostic card, means for influencing including a heating means for heating the measuring region and means for controlling the heating means, whereby the means for controlling is located on the computer and the transmitter is a two way transmitter for transmitting the digital sensory signal to the computer and for receiving control signals from the computer for operation of the heating means.

31. The card reader of claim 27, wherein the diagnostic card and card reader are constructed to perform an optical measurement of the sample.