Portable modular blood analyzer with simplified fluid handling sequence

• US 5,980,830 A
• Filed: 05/20/1996
• Issued: 11/09/1999
• Est. Priority Date: 05/20/1996
• Status: Expired due to Term

• Current Assignee: Radiometer California, Inc. (Danaher Corporation)
• Original Assignee: SenDx Medical, Inc. (Danaher Corporation)
• Inventors: Savage, Douglas Robert, Lawrence, Ronald Lee
• Primary Examiner(s): Le, Long V.
• Application Number:
  US08/650,341
• Time in Patent Office: 1,268 Days
• Field of Search: 422/61, 422/58, 422/68, 422/81, 422/100, 422/104, 422/103, 436/43, 436/46, 436/52, 436/174, 436/180, 436/183
• US Class Current: 422/81
• CPC Class Codes: G01N 2035/00326 Analysers with modular structure
• CPC Class Codes: G01N 33/4925 measuring blood gas content, e.g. O2, CO2 , HCO3
• CPC Class Codes: Y10T 436/11 Automated chemical analysis
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A portable, modular blood analyzer capable of analyzing multiple blood values in an inexpensive, relatively simple, easy-to-use and easy-to-maintain instrument. The invention comprises a three-part system including an analyzer body, calibrant cartridge, and sensor cartridge. A modular calibrant cartridge is insertable into the analyzer body, and contains all necessary calibrant fluids as well as a waste container. A modular sensor cartridge having integral pump tubing plugs into the analyzer body for easy removal and replacement of the sensor elements. The analyzer body internally has modular units including an electronics module, a display module, and a fluidics/printer module. The analyzer uses a single pump head to aspirate blood only to a sensor array within the sensor cartridge. This action is accomplished by aspirating blood by rotating an peristaltic pump in one direction during a first portion of an analysis cycle, and by reversing the pump and flushing the blood from the sensor cartridge with fluid pumped from the opposite direction during a second portion of an analysis cycle. Accordingly, blood contacts only a small portion of the analyzer mechanism, most of which is disposable. Because all valves are "downstream" from the single pump, no blood products pass through any valves. The analyzer fluid handling section is easily cleaned by removal of the sensor cartridge, yielding a single tube pathway. A short path length for blood travel permits using blood samples as small as 200 μl. The analyzer is light-weight and modular in design and is fully automatic.

Claims

1. A portable, modular blood analyzer capable of analyzing at least one analyte value of a blood sample, comprising:

(a) an analyzer body including analyte determination circuitry;

(b) a removable calibrant cartridge having at least one calibrant fluid container having calibrant fluid for performing at least one analysis of at least one analyte value of a blood sample, and having at least one waste container, the removable calibrant cartridge being configured to attach to the analyzer body without tools;

(c) a removable sensor cartridge having integral pump tubing, the sensor cartridge including at least one sensor for performing at least one analysis of at least one analyte value of a blood sample, the removable sensor cartridge being configured to attach to the analyzer body without tools, and, when so attached, to be in fluid communication with each calibrant fluid container and the waste container and in signal communication with the analyte determination circuitry;

(d) at least one valve situated to alternatively couple the sensor cartridge to a waste port and to at least one calibrant fluid container within the calibrant cartridge;

(e) a sample port, in fluid communication with the sensor cartridge, for drawing a blood sample into the sensor cartridge;

(f) a bidirectional pumping mechanism having a pump head and positioned between the sensor cartridge and each valve, for engaging the pump tubing of the sensor cartridge, and for selectively pumping in a direction towards the waste port and in a direction towards the sample port; and

(g) the blood analyzer is for automatically;

(1) switching each valve to couple the sensor cartridge to the waste port,

(2) actuating the bidirectional pumping mechanism to pump in a direction towards the waste port,

(3) drawing a blood sample into the sensor cartridge through the sample port,

(4) sensing desired analyte values of the blood sample within the sensor cartridge,

(5) switching each valve to couple the sensor cartridge to one of the calibrant fluid containers within the calibrant cartridge, and

(6) reversing each pump to pump fluid from the calibrant fluid container in a direction towards the sample port, thereby flushing the blood sample from the sensor cartridge and sample port.

2. The blood analyzer of claim 1, further including, internal to the analyzer body, an electronics module embodying control circuitry for receiving input signals from the removable sensor cartridge, for generating at least one analysis of at least one analyte value of a blood sample, for outputting the results of each such analysis, and for controlling the operation of the blood analyzer.

3. The blood analyzer of claim 1, further including a display module attached to the analyzer body, for displaying results of each such analysis.

4. The blood analyzer of claim 1, further including a printer module internal to the analyzer body, for printing results of each such analysis.

5. The blood analyzer of claim 1, wherein the blood analyzer with attached removable calibrant cartridge and removable sensor cartridge, weighs less than about 20 pounds.

6. The blood analyzer of claim 1, wherein the blood analyzer with attached removable calibrant cartridge and removable sensor cartridge, measures less than about 12"W×

12"D×

12"H.

7. The blood analyzer of claim 1, wherein the calibrant cartridge includes a latching mechanism to maintain a gas-tight fit with the analyzer body when the calibrant cartridge is attached to the analyzer body.

8. A portable, modular blood analyzer capable of analyzing at least one analyte value of a blood sample, comprising:

a. an analyzer body including at least one accessible pump head and analyte determination circuitry;

b. a removable calibrant cartridge having at least one calibrant fluid container having calibrant fluid for performing at least one analysis of at least one analyte value of a blood sample, and having at least one waste container, the removable calibrant cartridge being configured to attach to the analyzer body without tools and having a bayonet fitting corresponding to each calibrant fluid container and each waste container, each calibrant fluid container bayonet fitting being directly coupled to the corresponding calibrant fluid container without flexible tubing between the calibrant container bayonet fitting and the calibrant container and being mateable to a corresponding bayonet fitting on the analyzer body to ensure a substantially gas-tight coupling between the calibrant fluid container and the analyzer body, each waste container bayonet fitting being mateable to a corresponding bayonet fitting on the analyzer body; and

c. a removable sensor cartridge having integral pump tubing for peristaltic engagement with the pump head, the sensor cartridge including at least one sensor for performing at least one analysis of at least one analyte value of a blood sample, the removable sensor cartridge being configured to attach to the analyzer body without tools, and, when so attached, to be in fluid communication with each calibrant fluid container and the waste container and in signal communication with the analyte determination circuitry.

9. A portable, modular blood analyzer capable of analyzing at least one analyte value of a blood sample, comprising:

a. an analyzer body including at least one accessible pump head and analyte determination circuitry;

b. a modular removable calibrant cartridge having at least one calibrant fluid container having calibrant fluid for performing at least one analysis of at least one analyte value of a blood sample, and having at least one waste container, the removable calibrant cartridge being configured to attach to, and be removed from, the analyzer body without tools; and

c. a modular removable sensor cartridge having integral pump tubing for peristaltic engagement with the pump head, the sensor cartridge including at least one sensor for performing at least one analysis of at least one analyte value of a blood sample, the removable sensor cartridge being configured to attach to, and be removed from, the analyzer body without tools, and, when so attached, to be in fluid communication with each calibrant fluid container and the waste container and in signal communication with the analyte determination circuitry.

10. The blood analyzer of claim 9, further including, internal to the analyzer body, an electronics module embodying control circuitry for receiving input signals from the removable sensor cartridge, for generating at least one analysis of at least one analyte value of a blood sample, for outputting the results of each such analysis, and for controlling the operation of the blood analyzer.

11. The blood analyzer of claim 9, further including a display module attached to the analyzer body, for displaying results of each such analysis.

12. The blood analyzer of claim 9, further including a printer module internal to the analyzer body, for printing results of each such analysis.

13. The blood analyzer of claim 9, wherein the blood analyzer with attached removable calibrant cartridge and removable sensor cartridge, weighs less than about 20 pounds.

14. The blood analyzer of claim 9, wherein the blood analyzer with attached removable calibrant cartridge and removable sensor cartridge, measures less than about 12"W×

12"D×

12"H.

15. The blood analyzer of claim 9, wherein the calibrant cartridge includes a latching mechanism to maintain a gas-tight-fit with the analyzer body when the analyzer body is attached to the analyzer body.

16. The blood analyzer of claim 9, wherein the sensor cartridge is insertable into a front of the analyzer with the pump head accessible from the front of the analyzer.

17. The blood analyzer of claim 9, wherein the integral pump tubing of the sensor cartridge has two ends and is mounted to the cartridge at both ends.

18. The blood analyzer of claim 17, wherein the integral pump tubing is stretched around the pump head in peristaltic engagement.

19. The blood analyzer of claim 9, wherein the integral pump tubing is visible to an operator of the analyzer while in peristaltic engagement with the pump head.

20. The blood analyzer of claim 11, wherein the integral pump tubing and display module are simultaneously viewable by an operator when the tubing is in peristaltic engagement with the pump head.

21. The blood analyzer of claim 20, wherein the integral pump tubing of the sensor cartridge has two ends and is mounted to the cartridge at both said ends.