Self-activating hydratable solid-state electrode apparatus

• US 4,734,184 A
• Filed: 02/26/1987
• Issued: 03/29/1988
• Est. Priority Date: 08/29/1985
• Status: Expired due to Fees

• Current Assignee: Mallinckrodt Sensor Systems, Inc. (Mallinckrodt plc)
• Original Assignee: Diamond Sensor Systems Incorporated
• Inventors: Hendershot, Ricky, Burleigh, Peter, Burgess, Bruce
• Primary Examiner(s): Tung, T.
• Application Number:
  US07/021,520
• Time in Patent Office: 397 Days
• Field of Search: 204/1 T, 204/403, 204/409, 204/411, 204/415, 204/433, 128/635
• US Class Current: 204/409
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61M 1/36222 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2230/202 partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/207 hematocrit
• CPC Class Codes: A61M 2230/208 pH-value
• CPC Class Codes: G01N 33/4915 using flow cells flow cytometry G01N15/14
• CPC Class Codes: G01N 33/492 Determining multiple analytes

Abstract

This invention relates to solid-state electrode or micro-electrode sensor apparatus for measuring certain characteristics of an aqueous sample such as a body fluid or a blood sample and more particularly to such apparatus which employs a disposable cartridge containing a sensor or a bank of sensors for such characteristics and reagents used to calibrate the sensors.

Claims

1. An electrode assembly comprising:

a planar base member;

an elongated flow channel formed partially through the depth of the base member and opening to one surface thereof;

a plate member fixed to the surface of the base member which has the flow channel formed therein to close off the open side of the flow channel;

a first well of increased depth relative to the depth of the flow channel, formed in the base member along a portion of the length of the flow channel;

a second well of increased depth relative to the depth of the first well formed in the base member along a portion of the length of the first well;

an outer, planar, gas and water permeable, hydrophobic membrane layer formed over the entire surface of the first well and contacting the edges of the flow channel adjacent the first well so as to effectively form a portion of the wall of the flow channel over the first well;

an intermediate, planar, gas and water permeable, hydrophilic electrolyte membrane layer containing a pH buffer underlying the outer planar membrane, within the first well;

an inner, planar gas and water permeable hygroscopic electrolyte membrane layer conaining a pH buffer underlying the intermediate layer within the first well;

a conductive reference electrode passing through the thickness of the base member from the side opposite that containing the first well, at a point spaced from the second well, having one end in conductive contact with the underside of said inner planar electrolyte layer;

a conductive active electrode extending through the thickness of the base from the side opposite to that containing the wells at the area of the second well, so that one of its ends extends to the second well;

an active, inner, water permeable, electrolyte layer formed within the second well with one of its surfaces in contact with the active electrode surface which extends to the second well;

an active, outer, water permeable, polymeric pH sensitive layer filling the remaining volume of the second well so as to contact said active inner electrolyte layer and said inner planar hygroscopic electrolyte layer contained within the first well;

means for introducing aqueous fluid samples into the flow channel for measuring the content of carbon dioxide gas dissolved in the fluid; and

signal receiving means adopted to be connected to the ends of the active and reference electrodes opposite to the ends of those electrodes contacting the electrolyte layers;

whereby the assembly, when hydrated by an aqueous fluid sample, is capable of electrochemical interaction with the carbon dioxide content of an aqueous fluid sample such that an electric potential difference is generated between said electrodes as a function of the carbon dioxide content, for measurement by said signal receiving means.

2. An electrode assembly according to claim 1 where the reference electrode and the active electrode each have contact with the respective inner electrolyte layers through an electrode coupling surface.

5. An electrode assembly according to claim 2 where the reference electrode and the active electrode each have contact with the respective inner electrolyte layers through an electrode coupling surface.

3. An electrode assembly comprising:

a fluid flow channel;

a first outer, planar, gas and water permeable, hydrophobic member layer forming a poriton of the wall of said flow channel;

a second, intermediate, planar, gas and water permeable, hydrophilic electrolyte membrane layer containing a pH buffer in contact with said first membrane layer on the side opposite said flow channel;

a third, inner, planar, gas and water permeable hydroscopic electrolyte membrane layer containing a pH buffer in contact with at least a portion of said second membrane layer on the side opposite said first layer;

a conductive reference electrode having one end in contact with said third membrane layer;

a fourth, active, water permeable, polymeric, pH sensitive layer in contact with a portion of the surface of said third membrane layer opposite to the surface of that layer which is in contact with said second membrane layer;

a fifth, active, inner, water permeable electrolyte layer disposed in contact with a portion of the surface of said fourth layer;

a conductive active electrode having one end in contact with said fifth layer;

means for introducing aqueous fluid samples into the flow channel for measuring the content of carbon dioxide gas dissolved in the fluids; and

signal receiving means adapted to be connected to the ends of the active and reference electrodes opposite to the ends of those electrodes contacting the electrolyte layers for receiving and analyzing electrical signals;

whereby the assembly, when hydrated by an aqueous fluid sample, is capable of electrochemical interaction with the carbon dioxide content of an aqueous fluid sample such that an electric potential difference is generated between said electrodes as a function of the carbon dioxide content, for measurement by said signal receiving means.

4. The electrode assembly of claim 3 further including means for containing a calibrating facsimile fluid, and means for sequentially directing first said facsimile fluid and then said aqueous fluid sample through the flow channel, such that, during the time that the facsimile fluid is disposed in the flow channel the electrode assembly layers become hydrated and the signal sensing means receives a potential difference useful in calibrating the assembly for subsequent measurement of the carbon dioxide content of the fluid sample, when said fluid sample is in the flow channel in association with the still hydrated electrode assembly.