Portable immediate response medical analyzer having multiple testing modules

• US RE41,946 E1
• Filed: 05/22/2002
• Issued: 11/23/2010
• Est. Priority Date: 07/22/1997
• Status: Expired due to Term

• Current Assignee: Easydx Inc.
• Original Assignee: International Technidyne Corporation (Sphingotec GMBH)
• Inventors: Kurkowski, James D., Giddings, David T., Thompson, Robbi T., Sin, Kee Van, Anderson, Carter R.
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US10/153,081
• Time in Patent Office: 3,107 Days
• Field of Search: 204/403.01, 204/403.04, 204/412, 422/82.01, 422/82.03, 422/82.05, 422/58, 422/50, 205/777.5
• US Class Current: 205/792
• 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

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 is adapted to receive a removable test device having electrochemical sensors for making a plurality of determinations characteristic of a fluid serum sample selected from blood or other body fluid;

(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. the base unit including programming logic and circuitry for receiving signals from said permanent analytical module and one or more of said removable analytical modules and directing an analytical information output.

2. The device analyzer of claim 1 wherein at least one of said removable analytical modules also units is a module that makes a determination which utilizes a disposable test device that can be removed from the at least one of said removable modules.

3. The device analyzer of claim 2 wherein said disposable at least one of said removable module units that makes a determination which utilizes a test device that can be removed from the at least one of said removable module units is a removable module that uses a test strip.

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

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

6. The device analyzer of claim 1 wherein at least one or more types of module interface units include a unit which is connected to a communications IC.

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

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

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

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

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

13. The device analyzer of claim 12 wherein said module unit for performing general coagulation measurements performs at least one measurement from general coagulation measurements include including prothrombin time (PT), activated partial thrombo-plastin time (PTT) and activated clotting time (ACT) measurements.

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

15. The device analyzer of claim 14 wherein said device that makes cooximetry measurements is a device that can make co-oximetry measurements that include total homoglobin concentrations (tHb), oxyhemoglobin (O₂HB Q) measurements, carboxyhemoglobin (COHb) measurements and methemoglobin (MetHb) measurements.

22. The analyzer according to claim 1 including a display for displaying determinations from the analytical module units.

23. The analyzer according to claim 22 wherein the display is a video display.

24. The analyzer according to claim 23 wherein the video display is mounted in the base unit.

25. The analyzer according to claim 23 wherein the video display is an interactive display including a touch screen.

26. The analyzer according to claim 22 wherein the display is a printer.

27. The analyzer according to claim 26 wherein the printer is mounted in the base unit.

28. The analyzer according to claim 22 wherein the display includes both a printer and a video display.

29. The analyzer according to claim 28 wherein both the printer and the video display are mounted in the base unit.

30. The analyzer according to claim 1 including a communication port for sending results to an external or remote computer.

31. The analyzer according to claim 1 including no heating system, per se, in the base unit.

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 which uses a removable test cartridge having electrochemical sensors for making a plurality of determinations characteristic of a fluid serum sample selected from blood or other body fluids;

(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

the base unit including programming logic and circuitry for receiving signals from said permanent analytical module and one or more of said removable analytical modules and directing an analytical information output; 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 analyzer of claim 16 wherein at least one module interface unit is connected through a multiplexer to a communications IC.

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

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

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

32. A portable medical analyzer comprising:

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

(b) one or more module interface units for connecting and interfacing between one or more analytical module units and said base unit;

(c) at least one permanent analytical module integral with said base unit which is adapted to receive a removable test device having electrical, electrochemical, optical or mechanical sensors for making determinations characteristic of a fluid sample selected from blood or other body fluid;

(d) the base unit being adapted to receive at least one removable analytical module unit for making analytical determinations of blood or other body fluid; and

to connect, through a module interface unit, to the at least one removable analytical module; and

(e) the base unit including programming logic and circuitry for receiving signals from the at least one removable analytical module unit, when attached thereto, and also from the permanent analytical module, and directing an analytical output.

33. A portable medical analyzer according to claim 32 including:

(a) a removable analytical module mounted thereon;

(i) the removable analytical module mounted on the base unit being configured to make determinations characteristic of a fluid sample selected from blood or other body fluid.

34. A portable medical analyzer according to claim 33 wherein:

(a) the analytical module permanently mounted on the base unit includes a cartridge receptacle having a pair of guide flanges to hold, in use, a removable sample cartridge.

35. A portable medical analyzer according to claim 32 wherein:

(a) the base unit includes a temperature sensing device positioned to determine a temperature corresponding to a sample temperature in a removable sample cartridge, when the removable sample cartridge is mounted in the analytical module permanently mounted on the base unit.

36. A portable medical analyzer according to claim 32 wherein:

(a) the base unit includes a heating control system and programming, to selectively control a temperature of a sample included in a removable sample cartridge, when the removable sample cartridge is mounted in the analytical module permanently mounted on the base unit.

37. A portable medical analyzer according to claim 32 wherein:

(a) the analyzer includes programming logic for operating the permanent analytical module in both a calibration mode and sample determination mode.

38. A portable medical analyzer according to claim 32 including a display for displaying determinations from the analytical modules.

39. A portable medical analyzer according to claim 38 wherein the display is a video display.

40. A portable medical analyzer according to claim 39 wherein the video display is mounted in the base unit.

41. A portable medical analyzer according to claim 39 wherein the video display is an interactive display including a touch screen.

42. A portable medical analyzer according to claim 38 wherein the display is a touch screen.

43. A portable medical analyzer according to claim 42 further comprising a printer mounted in the base unit.

44. A portable medical analyzer of claim 32 including a removable analytical module mounted on the base unit which is configured for performing general coagulation of a blood sample.

45. A portable medical analyzer of claim 44 wherein the module for performing general coagulation measurements is configured to perform at least one measurement from general coagulation measurements including prothrombin time (PT), activated partial thrombotlastin time (PTT) and activated clotting time (ACT) measurements.

46. A portable medical analyzer of claim 32 including a removable analytical module having a visible light sensing device that makes co-oximetry measurements.

47. A portable medical analyzer of claim 46 wherein the device that makes co-oximetry measurements is a device that can make co-oximetry measurements that include total hemoglobin concentrations (tHb), oxyhemoglobin (O₂Hb) measurements, carboxyhemoglobin (COHb) measurements and methemoglobin (MetHb) measurements.

48. A portable medical analyzer of claim 32 including a removable analytical module comprising a glucose meter.

49. A portable medical analyzer according to claim 32 including:

(a) a cassette removably engaged with the base unit, the cassette including at least two analytical testing modules;

(i) each one of two testing modules included in the cassette being operatively coupled to the base unit.

50. A portable medical analyzer according to claim 49 wherein:

(a) each module included in the cassette is removably mounted in the cassette.

51. A portable medical analyzer according to claim 32 including:

(a) a removable and replaceable power supply, including a battery pack, mounted on the base unit.

52. A portable medical analyzer according to claim 32 including:

(a) a communication link for communicating analytical information from the base unit to a remote computer.

53. A portable medical analyzer comprising:

(a) a base unit having a main CPU and circuitry to process electrical signals received from electrical, electrochemical, optical or mechanical sensors of at least two associated analytical modules if and when one or more of the at least two analytical modules is operated to evaluate blood or other body fluid removed from a patient;

(b) one or more module interface units for connecting and interfacing between the base unit and at least two non-disposable analytical modules capable of making determinations characteristic of fluid selected from blood or other body fluid removed from a patient and presented to the analytical modules via one or more disposable test units;

(c) the base unit including programming logic and circuitry for receiving signals from at least two analytical modules, operated to evaluate blood or other body fluid removed from a patient in selected use, and directing an analytical information output;

(d) wherein the combination of the base unit and the module interface units enables utilization of output signals from at least two associated analytical modules, in selected operation to evaluate blood or other body fluid removed from a patient.

54. A portable medical analyzer according to claim 53 including:

(a) an analytical module mounted thereon;

(i) the analytical module mounted on the base unit being configured to make determinations characteristic of a fluid sample selected from blood or other body fluid removed from a patient.

55. A portable medical analyzer according to claim 53 including:

(a) two analytical modules connected thereto;

(i) at least one of the two analytical modules being removably mounted on the medical analyzer;

(ii) each one of the two analytical modules being configured to make determinations characteristic of a fluid sample selected from blood or other body fluid removed from a patient.

56. A portable medical analyzer according to claim 55 wherein:

(a) the base unit, one or more module interface units and two analytical modules are configured for selected simultaneous operation of the two analytical modules to provide output signals to the base unit.

57. A portable medical analyzer according to claim 55 wherein:

(a) the two analytical modules are configured to make different determinations from one another, each of which is characteristic of blood or other body fluid removed from a patient.

58. A portable medical analyzer according to claim 53 including:

(a) a first analytical module attached thereto;

(i) the first analytical module being configured to make determinations characteristic of a fluid sample selected from blood or other body fluid removed from a patient;

(b) a second analytical module connected to the base unit which is adapted to receive a glucose test strip, to make a glucose determination of blood.

59. A portable medical analyzer according to claim 53 including:

(a) a first analytical module attached thereto;

(i) the first analytical module being configured to make determinations characteristic of a fluid sample selected from blood or other body fluid removed from a patient; and

,

(b) a removable second analytical module.

60. A portable medical analyzer according to claim 53 including:

(a) a display for displaying determinations made from one or more analytical modules.

61. A portable medical analyzer according to claim 60 wherein the display is a video display.

62. A portable medical analyzer according to claim 53 including a communication port for sending results to an external or remote computer.

63. A portable medical analyzer according to claim 53 including:

(a) a removable analytical module mounted thereon;

(i) the removable analytical module mounted on the base unit being configured to make determinations characteristic of a fluid sample selected from blood or other body fluid removed from a patient.

64. A portable medical analyzer according to claim 53 including:

(a) an analytical module mounted on the base unit configured to make determinations characteristic of a fluid sample selected from blood or other body fluid removed from a patient and selected from at least one of;

(i) pH;

(ii) pO₂;

(iii) pCO₂;

(iv) Na⁺;

(v) Ca⁺⁺;

(vi) K⁺;

(vii) hematocrit;

(viii) glucose;

(ix) general coagulation measurements; and

(x) co-oximetry measurements.

65. A portable medical analyzer according to claim 53 including:

(a) an analytical module permanently mounted on the base unit that includes a cartridge receptacle having a pair of guide flanges to hold, in use, a removable sample cartridge.

66. A portable medical analyzer according to claim 53 wherein:

(a) the base unit includes a temperature sensing device positioned to determine a temperature corresponding to a sample temperature in at least one removable sample cartridge, when the removable sample cartridge is mounted in an analytical module on the base unit.

67. A method comprising a step of:

operatively connecting a removable analytical module having a receiver for a disposable test unit to a portable medical analyzer comprising;

(a) a base unit having a main CPU and circuitry to process electrical signals generated by electrical, electrochemical, optical or mechanical sensors positioned in at least two analytical modules at least if and when each of the at least two analytical modules is operated to evaluate blood or other body fluid removed from a patient;

(b) one or more analytical module interface units for connecting and interfacing between one or more analytical modules and said base unit;

(c) the base unit being adapted to receive signals from at least two analytical modules, at least one of which is the removable analytical module, for making analytical determinations of blood or other body fluid removed from a patient; and

, to connect, through a module interface unit, to the at least two analytical modules; and

,

(d) the base unit including programming logic and circuitry for receiving signals from the analytical modules when attached thereto, and directing an analytical output.

68. A method according to claim 67 wherein:

(a) said step of operatively connecting a removable module comprises connecting the removable module to a portable medical analyzer already including a permanent analytical module adapted to receive a removable sample containing test device configured to evaluate at least one of pH, pO₂, pCO₂, Na⁺, Ca⁺⁺, K⁺, and hematocrit.