Electrochemical sensing apparatus with in situ calibration

• US 4,478,222 A
• Filed: 03/10/1981
• Issued: 10/23/1984
• Est. Priority Date: 03/10/1980
• Status: Expired due to Term

• Current Assignee: Cordis Europa NV (Johnson & Johnson)
• Original Assignee: Cordis Europa NV (Johnson & Johnson)
• Inventors: Bergveld, Piet, Koning, Gerrit
• Primary Examiner(s): Padgett, Benjamin R.
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US06/242,351
• Time in Patent Office: 1,323 Days
• Field of Search: 128/635, 128/632, 204/195 B, 204/195 R, 204/195 F, 204/1 H
• US Class Current: 600/348
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G01N 27/28 Electrolytic cell components
• CPC Class Codes: G01N 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence
• CPC Class Codes: G01N 27/4165 for pH meters

Abstract

An in vivo electrochemical monitoring device is formed by a catheter-like member which terminates in a closed end having a wall with a fixed opening to admit fluid to be tested, such as blood in an artery. An electrochemical sensor, such as an ISFET device for monitoring the concentration of a particular ion in blood, is mounted inside the tube at a fixed location below the opening preferably a larger sensing chamber. an infusion channel in the tube is arranged to flood the sensor with a fluid of known chemical properties so that the sensor output can be calibrated. Under pressure the calibration fluid expels the test fluid out of the tube or chamber via the fixed opening. A method of constructing a suitable chamber on an ISFET wafer is also disclosed.

Claims

1. A chemically sensitive probe for taking measurement of the chemical properties of biological fluids in vivo with in vivo recalibration, comprising

a closed tube having a wall with a fixed opening to admit fluid to be tested,

an electrochemical sensor assembly affixed to the inside wall of said tube covering said opening to define therewith a sensing chamber, and

means defining an infusion channel in said tube for flooding said sensor assembly with a known fluid for calibration during which the fluid to be tested is temporarily expelled through said opening.

2. The apparatus of claim 1, wherein said infusion channel is formed in the interior of the sidewall of said tube.

3. The apparatus of claim 2, wherein said sensor assembly is substantially flush with the inside wall surrounding said opening.

4. The apparatus of claim 3, wherein the outer portion of the wall defining said infusion channel is extended to partially overlie said opening thus forming at the surface of the tube a threshold passage to said opening of reduced cross-sectional area relative to the subjacent portion of said opening.

5. The apparatus of claim 1, wherein said infusion channel is formed by a separate inner tube extending axially through said closed tube and passing sealingly through said sensor assembly into fluid communication with said sensing chamber.

6. The apparatus of claim 1, wherein said opening is tapered with the portion of reduced cross-sectional area lying closer to the outer surface of the tube.

7. The apparatus of claim 1, wherein said chamber comprises an electrically conductive material.

8. The apparatus of claim 1, wherein said sensor assembly is larger than said opening.

9. An electrochemical sensing cell for a chemically sensitive probe for taking measurement of the chemical properties of biological fluids in vivo with in vivo recalibration comprising

a wafer comprising an ISFET with a chemically sensitive surface area,

a body affixed on top of said wafer having a central recess formed in the adjacent face thereof encompassing said chemically sensitive area and defining therewith a sensing chamber,

a port extending from said chamber through said body to admit fluid to be tested, and

a calibration channel through said wafer leading to said chamber to flood said chemically sensitive area with a known fluid for calibration during which said fluid to be tested is expelled through said port.

10. The cell of claim 9, wherein said body is electrically conductive.

11. The cell of claim 9, further comprising

a hollow catheter having an aperture formed therein,

said body being bonded to the inside wall of said catheter with said port extending therethrough in communication with said fluid to be tested via said aperture.

12. A chemically sensitive probe for taking measurement of the chemical properties of biological fluids in vivo with in vivo recalibration, comprising

a catheter,

means defining an enclosed sensing chamber inside the distal end of said catheter,

a chemically sensitive electrical device disposed in said chamber at a fixed location,

first port means defined through an outside wall of said catheter for admitting bodily fluid into said chamber for testing,

second port means for admitting calibration fluid to said chamber, and

duct means carried within said catheter for supplying said chamber with calibration fluid via said second port thereby expelling bodily fluid from said chamber via said first port during recalibration of said device.

13. The probe of claim 12, wherein the cross-sectional area of each of said ports at the respective entry to said chamber is substantially less than the maximum cross-sectional area of said chamber, whereby said chamber forms a distinct reservoir and ingress via said first port means is dependent upon a lack of pressure at said second port means to prevent intermixing during recalibration.

14. The probe of claim 12, further comprising

means separate from said catheter for defining a Faraday cage surrounding said sensing chamber to reduce electrical interference.