Electrochemical sensor apparatus and method

• US 5,165,406 A
• Filed: 09/13/1990
• Issued: 11/24/1992
• Est. Priority Date: 09/13/1990
• Status: Expired due to Term

• Current Assignee: Segars California Partners, LP
• Original Assignee: VIA Medical Corporation (Medtronic Plc)
• Inventors: Wong, David K.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): PONTIUS, KEVIN LANE
• Application Number:
  US07/581,803
• Time in Patent Office: 803 Days
• Field of Search: 128/630, 128/632, 128/635, 128/637, 128/760, 604/4, 204/403, 204/411, 204/409
• US Class Current: 600/345
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A sensor assembly for a combination infusion fluid delivery system and blood chemistry analysis system includes a sensor assembly with each of the assembly electrodes mounted in an electrode cavity in the assembly. Each electrode cavity includes a circular ridge that defines a cylindrical inner cavity and a ring-shaped outer cavity. The circular ridge prevents the water soluble gel from wicking into the surrounding selectively-permeable membrane, and thereby provides easier manufacture, higher yield rates, and longer shelf life. A helical groove increases turbulence in the assembly, reducing the purge volume needed to flush the assembly after each sample measurement. The system includes provision for delivering the infusion fluid and measuring blood chemistry during reinfusion of the blood at approximately the same flow rates.

Claims

1. An electrochemical electrode assembly for measuring the characteristics of a fluid flowing through the assembly, the assembly having a housing with a fluid flow pathway and with at least one electrode cavity in the housing located adjacent to the fluid flow pathway, and at least one electrode embedded in a bottom wall of the electrode cavity, the assembly further comprising:

separation means for dividing the electrode cavity into two sub-cavities comprising a selectively-permeable material portion and a reference material portion that is contained within the selectively-permeable material portion, and for defining a sharp corner in the electrode cavity between the two portions;

an internal reference material deposited in the reference material portion; and

an ion-selective material deposited in the selectively-permeable material portion.

2. An electrode assembly as recited in claim 1, further comprising turbulence means located upstream of the electrode cavity for generating turbulence in the fluid flow through the fluid flow channel of the assembly.

3. An electrode assembly as recited in claim 2, wherein the turbulence means comprises a helical groove in the portion of the housing that defines the fluid flow pathway.

4. An electrode assembly as recited in claim 1, wherein the separation means comprises a circular ridge projecting upwardly from the bottom wall of the electrode cavity, defining the selectively-permeable material portion as an outer ring-shaped recess and defining the reference material portion as a centrally-located, generally cylindrical recess.

5. An electrochemical electrode assembly for measuring the characteristics of a fluid flowing through the assembly, the assembly having a base with a fluid flow channel and with at least one electrode cavity located adjacent to the channel and at least one electrode embedded in the bottom wall of the electrode cavity, the assembly further comprising:

a circular ridge projecting upwardly rom the bottom wall of the electrode cavity, dividing the electrode cavity into an outer ring-shaped recess and a centrally-located generally cylindrical recess, the circular ridge having a sharp corner at its top edge encircling the cylindrical recess;

an internal reference material deposited into the cylindrical recess so as to cover the top of the embedded electrode; and

a selectively-permeable material filling the remainder of the electrode cavity.

6. An electrochemical electrode assembly for connection in the path of a fluid flow line and for measuring the characteristics of a fluid flowing through the flow line, comprising:

an elongated reference assembly having at least one reference electrode;

an elongated sensor assembly having at least one sensor electrode sensitive to a predetermined ion;

a connecting flow line carrying the fluid to be measured between the reference assembly and sensor assembly;

wherein the reference assembly and sensor assembly are mounted in side-by-side relationship;

control means for regulating the flow of the fluid through the assembly; and

fluid sensing means for sensing the presence of the fluid in the connecting flow line and providing this information to the control means;

wherein the control means determines when the fluid should be present in the sensor assembly for proper operation and provides an error signal when proper operation is not indicated.

7. An electrochemical electrode assembly as recited in claim 6, wherein the connecting flow line has a length of approximately 4 to 6 inches.

8. An electrochemical electrode assembly as recited in claim 6, wherein the inside diameter of the connected flow line is greater than the inside diameter of the flow line.

9. An electrochemical electrode assembly for connection in the path of a fluid flow line and for measuring the characteristics of a fluid flowing through the flow line comprising:

an elongated reference assembly having at least one reference electrode;

an elongated sensor assembly having at least one sensor electrode sensitive to a predetermined ion; and

a connecting flow line carrying the fluid to be measured between the reference assembly and sensor assembly;

wherein the reference assembly and sensor assembly are mounted in side-by-side relationship;

and wherein either the reference assembly or sensor assembly, or both, includes

a base with at least one electrode cavity having an electrode embedded in a bottom wall of the cavity, and

separation means for dividing the electrode cavity into two sub-cavities comprising a selectively-permeable material portion and a reference material portion that is contained the selectively-permeable material portion, and for defining a sharp corner in the electrode cavity between the two portions.

10. An electrochemical electrode assembly as recited in claim 9, further comprising turbulence means upstream of the electrode cavity for generating turbulence in the fluid flow through the assembly.

11. An electrochemical electrode assembly as recited in claim 10, wherein the turbulence means comprises helical grooves in the reference assembly and the sensor assembly.

12. An electrochemical electrode assembly as recited in claim 9, wherein the separation means comprises a circular ridge projecting upwardly from the bottom wall of the electrode cavity, defining the selectively-permeable material portion as an outer ring-shaped recess and defining the reference material portion as a centrally-located, generally cylindrical recess.

13. A method of computing a predetermined ion level in a test material from a patient, the method comprising the steps of:

providing a sensor assembly having a fluid flow pathway for flow of the test material, the fluid flow pathway having an upstream end and a downstream end that is in communication with the patient, the sensor assembly having a reference electrode and sensor electrodes mounted in the assembly in communication with the flow of the test material, the reference electrode being upstream of the sensor electrodes;

providing a calibration fluid communicating with the sensor assembly at the upstream end;

controlling the flow of the calibration fluid into the sensor assembly during a calibration mode at a predetermined calibration flow rate;

halting the flow of the calibration fluid to begin a measurement mode;

drawing a sample of test material from the patient into the sensor assembly up to, but not reaching, the reference electrode; and

controlling the flow of the test material through the sensor assembly past the sensor electrode back into the patient so as to have a fluid flow rate approximately equal to the calibration flow rate during the calibration mode.

14. A method as recited in claim 13, wherein the calibration fluid is an infusion fluid that is infused into the patient during the calibration mode.

15. An electrochemical sensor apparatus for a combined infusion fluid delivery and blood chemistry monitoring system for measuring the characteristics of a patient'"'"'s blood during a measurement mode and for calibrating the measurement during a calibration mode, the apparatus comprising:

a sensor electrode assembly having a base with at least one electrode cavity and at least one sensor electrode embedded in a bottom wall of the electrode cavity;

a pump in flow communication with the patient'"'"'s blood and the infusion; and

a controlling means for regulating the pump so as to control the flow of the infusion fluid into the patient and the withdrawal of the blood from the patient and the reinfusion of the blood back into the patient such that infusion fluid flows into the patient during the calibration mode and blood flows into the patient during the measurement mode;

wherein the controlling means regulates the flow of infusion fluid during the calibration mode and regulates the flow of blood during the measurement mode to be at substantially equal flow rates.

16. An electrochemical sensor apparatus as recited in claim 15, further including a reference assembly having at least one reference electrode substantially identical to the sensor electrode, mounted in the fluid flow of the apparatus, upstream of the sensor assembly.

17. An electrochemical sensor apparatus as recited in claim 16, wherein the controlling means further regulates the pump during the measurement mode such that the pump draws blood into the apparatus past the sensor assembly but stops it short of the reference assembly.

18. An electrochemical sensor apparatus as recited in claim 16, wherein the sensor assembly includes turbulence means upstream of the electrode cavity for generating turbulence in the fluid flow through the assembly.

19. An electrochemical sensor apparatus as recited in claim 18, wherein the turbulence means comprises helical grooves in the sensor electrode assembly and the reference assembly.

20. An electrochemical sensor apparatus for a combined infusion fluid delivery and blood chemistry monitoring system for measuring the characteristics of a patient'"'"'s blood during a measurement mode and for calibrating the measurement during a calibration mode, the apparatus comprising:

a sensor electrode assembly having a base with at least one electrode cavity and at least one sensor electrode embedded in a bottom wall of the electrode cavity;

a pump in flow communication with the patient'"'"'s blood and the infusion fluid; and

a controller that regulates the pump so as to control the flow of the infusion fluid into the patient and the withdrawal of the blood from the patient and the reinfusion of the blood back into the patient such that infusion fluid flows into the patient during the calibration mode and blood flows into the patient during the measurement mode, wherein the controller regulates the flow of infusion fluid during the calibration mode and regulates the flow of blood during the measurement mode to be at substantially equal flow rates;

a reference assembly having at least one reference electrode, substantially identical to the sensor electrode, mounted in the fluid flow of the apparatus, upstream of the sensor assembly; and

a length of conduit extending between the sensor assembly and the reference assembly, wherein the sensor assembly and reference assembly are mounted adjacent each other and the conduit between them is formed into a loop.

21. An electrochemical sensor apparatus as recited in claim 20, wherein the loop is approximately from 4 to 6 inches in length.

22. An electrochemical sensor apparatus for a combined infusion fluid delivery and blood chemistry monitoring system for measuring the characteristics of a patient'"'"'s blood during a measurement mode and for calibrating the measurement during a calibration mode, the apparatus comprising:

a sensor electrode assembly having a base with at least one electrode cavity and at least one sensor electrode embedded in a bottom wall of the electrode cavity;

a pump in flow communication with the patient'"'"'s blood and the infusion fluid;

a controller that regulates the pump so as to control the flow of the infusion fluid into the patient and the withdrawal of the blood from the patient such that infusion fluid flows into the patient during the calibration mode and blood is withdrawn from the patient during the measurement mode, wherein the controller regulates the flow of infusion fluid during a calibration mode and regulates the flow of blood during a measurement mode to be at substantially equal flow rates; and

a reference assembly having at least one reference electrode, substantially identical to the sensor electrode, mounted in the fluid flow of the apparatus, upstream of the sensor assembly;

wherein the reference assembly includes a keying electrode whose resistance is set to a predetermined magnitude indicating the type of sensor electrodes present in the sensor electrode assembly.