Portable immediate response medical analyzer having multiple testing modules

• US 6,066,243 A
• Filed: 07/21/1998
• Issued: 05/23/2000
• Est. Priority Date: 07/22/1997
• Status: Expired

• Current Assignee: Easydx Inc.
• Original Assignee: Diametrics Medical, Inc. (Allegro Biodiesel Corp.)
• Inventors: Anderson, Carter R., Kurkowski, James D., Giddings, David T., Thompson, Robbi T., Sin, Kee Van
• Primary Examiner(s): Tung, T.
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/119,983
• Time in Patent Office: 672 Days
• Field of Search: 204/403, 204/400, 204/416, 204/418, 204/419, 204/420, 422/82.01, 422/82.05
• US Class Current: 422/82.01
• 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: G16H 40/63 for local operation

Abstract

A portable device that includes a plurality of test modules for analyzing preselected concentrations of various body fluids of a patient. The portable diagnostic device interfaces and utilizes disposable cartridges and reagent diagnostic test strips and other fluid sample diagnostic devices to determine the amounts of preselected parameters in a patient'"'"'s blood through either electrochemical, electrical, optical, or mechanical analysis. The disposable fluid sample diagnostic devices may include sample chambers with inlet ports, electrical, physical, or chemical sensors, in situ calibration media, a plurality of electrical interface terminals, and temperature control elements. An electrical interface interconnects the various test modules with one or more corresponding integrated circuits which in turn are electrically coupled to a common interactive display, printer, power supply, and communication ports.

Claims

1. A portable point of care medical analyzer that enables an operator to rapidly obtain results for a plurality of diverse analyses, said analyzer comprising:

(a) a base unit having a main CPU and including signal processing devices and circuitry for rapid processing of electrical signals generated by electrical, electrochemical, optical or mechanical sensors of one or more associated analytical modules;

(b) at least one permanent analytical module integral with said base unit which includes a disposable test device having electrochemical sensors for making a plurality of determinations characteristic of a fluid serum sample;

(c) one or more types of module interface units for connecting and interfacing between one or more removable analytical module units and said base unit;

(d) one or more dedicated removable analytical module units for making specific determinations and which are designed to be plugged into said base unit and connect electrically to a specific type of modular interface unit;

(e) wherein the combination of said base unit signal processing devices and circuitry and said module interface units enables direct utilization of the output signals from each of said removable modules; and

(f) common output devices in said base unit for providing visual or printed display of determinations from all modules.

2. The device of claim 1 wherein at least one of said removable analytical modules also makes a determination which utilizes a disposable test device.

3. The device of claim 2 wherein said disposable test device is a test strip.

4. The device of claim 3 wherein said test strip is used in a glucose meter.

5. The device of claim 2 wherein said one or more removable analytical modules include a glucose meter.

6. The device of claim 1 wherein at least one module interface unit is connected to a communications IC.

7. The device of claim 6 wherein said one or more removable analytical modules include a glucose meter.

8. The device of claim 6 wherein said one or more removable analytical modules include a prothrombic time assay module for performing general coagulation measurements.

9. The device of claim 6 including a plurality of module interface units connected through a multiplexer to said communications IC.

10. The device of claim 1 wherein at least one module interface unit is connected directly with said main CPU of said base unit.

11. The device of claim 1 wherein at least one module interface unit is connected to said main CPU of said base unit through an analog interface.

12. The device of claim 1 wherein said one or more removable analytical modules include a module for performing general coagulation measurements.

13. The device of claim 12 wherein said general coagulation measurements include prothrombin time (PT), activated partial thrombo-plastin time (PTT) and activated clotting time (ACT).

14. The device of claim 11 wherein said one or more dedicated removable analytical modules includes a visible light sensing device that makes co-oximetry measurements.

15. The device of claim 14 wherein said co-oximetry measurements include total homoglobin concentrations (tHb), oxyhemoglobin (O₂ HB), carboxyhemoglobin (COHb) and methemoglobin (MetHb).

16. A portable point of care medical analyzer that enables an operator to rapidly obtain results for a plurality of diverse analyses, said analyzer comprising:

(a) a base unit having a main CPU and including signal processing devices and circuitry for rapid processing of electrical signals generated by electrical, electrochemical, optical or mechanical sensors of one or more associated analytical modules;

(b) at least one permanent analytical module integral with said base unit including a disposable test cartridge having electrochemical sensors for making a plurality of determinations characteristic of a fluid serum sample;

(c) one or more types of module interface units for connecting and interfacing between one or more removable analytical module units and said base unit;

(d) one or more dedicated removable analytical module units for making specific determinations and which are designed to plug into said base unit and connect electrically to a specific type of modular interface unit;

(e) wherein the combination of said base unit signal processing devices and circuitry and said module interface unit enables direct utilization of the output signals from each of said removable modules;

(f) common output devices in said base unit for providing visual or printed display of determinations from all modules; and

(g) wherein at least one removable analytical module is designed to attach to another removable analytical module in a stacked arrangement in a manner such that both removable modules connect to a module interface unit.

17. The device of claim 16 wherein at least one module interface unit is connected through a multiplexer to a communications IC.

18. The device of claim 16 wherein at least one module interface unit is connected directly with said main CPU of said base unit.

19. The device of claim 16 wherein at least one module interface unit is connected to said main CPU of said base unit through an analog interface.

20. The device of claim 16 wherein said one or more removable analytical modules include a glucose meter.

21. The device of claim 16 comprising a removable glucose meter mounted from a prothrombic time assay module.