Sensor cartridge for a fluid analyte analyzer

• US 6,146,510 A
• Filed: 05/16/1996
• Issued: 11/14/2000
• Est. Priority Date: 05/16/1996
• Status: Expired due to Term

• Current Assignee: Radiometer California, Inc.
• Original Assignee: SenDx Medical, Inc. (Danaher Corporation)
• Inventors: Savage, Douglas R., Leader, Matthew J., Graves, Jeffrey
• Primary Examiner(s): Tung, T.
• Application Number:
  US08/648,676
• Time in Patent Office: 1,643 Days
• Field of Search: 204/415, 204/416, 204/418, 204/419, 204/403, 204/412, 205/782.5, 205/783, 205/789, 205/789.5
• US Class Current: 204/403.01
• CPC Class Codes: G01N 33/4925 measuring blood gas content, e.g. O2, CO2 , HCO3

Abstract

The present invention is a sensor formed over a subminiature through hole. Because of the small diameter of the through hole, the material that fills the through hole and the through hole itself have an essentially negligible effect on the sensor. Only a small amount of conductive material which fills each through hole is in contact with each associated electrode. Therefore, the purity of the electrode is not significantly altered by the conductive material coupled to the electrode. A relatively large number of sensors can be formed on the surface of the substrate within a relatively small fluid flowcell. Thus, more information can be attained using less blood. The sensors of the present invention are preferably disposed on an alumina substrate which is essentially impervious to aqueous electrolytes and blood over long periods of storage in potentially corrosive environments. Since the substrate on which the sensors are deposited does not break down or become unstable when exposed over time to such corrosive environments, the isolation that is provided by the substrate remains very high between each sensor and each other sensor, between each sensor and each conduction path, and between each conduction path and each other conduction path. The superior isolation provided by the substrate provides for a high level of accuracy in the sensor of the present invention. Furthermore, the use of the through holes allows the conduction paths between the electrodes of the sensors and any external devices to be exclusively on the opposite side of the substrate from the sample. This physical isolation of the sample from the conduction paths between the sensor electrodes and external devices ensures very high electrical isolation between each of the sensors is maintained over an extended period time during which corrosive fluids (such as electrolytes and/or blood) are present in the flowcell.

Claims

1. A sensor cartridge for a fluid analyte analyzer, including

a. a sensor assembly, including:

i. an electrically insulating substrate on which said sensor assembly is formed, the substrate having a planar surface defining a first side;

ii. a plurality of sensors having a diameter between about 0.046 to about 0.078 inch deposited on said planar surface of said first side of the substrate;

iii. a plurality of electrical conductors deposited on a second side of the substrate;

iv. a plurality of subminiature thru-holes having a diameter in the range of about 0.002 to 0.006 inch filled with electrically conductive material, each thru-hole disposed directly under a corresponding one of the sensors for coupling one of the sensors with one of the electrical conductors;

v. an electrical connector disposed on the second side of the substrate, the connector having a plurality of electrical contacts, at least some of the electrical contacts corresponding one to one with an associated one of the electrical conductors and at least some of the electrical contacts being

coupled to the associated one of the electrical conductors; and

b. an encasement into which the sensor assembly is placed for directing the flow of the analyte over the sensors, and preventing contact of the analyte with the second side of the substrate, including;

i. an inlet for allowing the fluid analyte to enter the encasement;

ii. an outlet for allowing the fluid analyte to exit the encasement;

iii. a flow channel between the inlet and the outlet for allowing the fluid analyte to pass through the housing and over each of the sensors; and

iv. an opening at one side for exposing the electrical connector.

2. The sensor cartridge of claim 1, wherein the electrical connector is a surface mount connector.

3. The sensor cartridge of claim 1, wherein the encasement further includes a reference cell.

4. The sensor cartridge of claim 3, wherein the reference cell is filled with a reference gel.

5. The sensor cartridge of claim 4, wherein the reference gel has a greater viscosity in a range of about 18-25°

C. than at about 37°

-50°

C.

6. The sensor cartridge of claim 3, further including a third cell which reduces the amount of encasing material adjacent the flow channel, the third cell and the reference cell disposed symmetrically about the flow channel.

7. The sensor cartridge of claim 3, further including a reference channel between the reference cell and the flow channel.

8. The sensor cartridge of claim 7, wherein the reference channel is less than about 0.010 inch in diameter.

9. The sensor cartridge of claim 1, wherein the flow channel has a total volume of approximately 0.05 milliliter.

10. The sensor cartridge of claim 1, wherein the flow channel has a height of less than approximately 0.10 inch.

11. The sensor cartridge of claim 1, wherein the encasement is formed of a composition of acrylic, styrene, and butadiene.

12. The sensor cartridge of claim 1, wherein the outside dimensions of the encasement are less than 0.5 inch by 0.2 inch by 0.25 inch.

13. The sensor cartridge of claim 1, wherein the sensor assembly is secured within the encasement by an adhesive.

14. The sensor cartridge of claim 1, wherein:

(c) the plurality of sensors includes an oxygen sensor; and

(d) the flow channel includes a dome which increases the volume of the flow channel locally about the oxygen sensor.

15. The sensor cartridge of claim 14, wherein the oxygen sensor is an amperometric cell.

16. The sensor cartridge of claim 1, wherein the plurality of sensors include:

(a) a sodium sensor;

(b) a potassium sensor

(c) a calcium sensor

(d) a pH sensor

(e) a carbon dioxide sensor

(f) an oxygen sensor; and

(g) a hematocrit value sensor.

17. The sensor cartridge of claim 16, wherein the sodium sensor, potassium sensor, calcium sensor, and carbon dioxide sensor are ion sensitive sensors.

18. A sensor cartridge for a fluid analyte analyzer, comprising:

a housing having an inlet and an outlet and a flow channel for allowing the fluid analyte to enter the housing;

a sensor assembly disposed in said flow channel between the inlet and the outlet;

said sensor assembly, comprising;

an electrically insulating substrate on which said sensor assembly is formed, the substrate having a first side defined by a planar surface;

a plurality of sensors having a diameter between about 0.046 to about 0.078 inch deposited on said planar surface of said substrate;

a plurality of electrical conductors deposited on a second side of the substrate;

a plurality of subminiature thru-holes having a diameter in the range of about 0.002 to 0.006 inch filled with electrically conductive material, each thru-hole disposed directly under a corresponding one of the sensors for coupling one of the sensors with one of the electrical conductors; and

an electrical connector disposed on the second side of the substrate, the connector having a plurality of electrical contacts, at least some of the electrical contacts corresponding one to one with an associated one of the electrical conductors and at least some of the electrical contacts being coupled to the associated one of the electrical conductors, said connector being accessible from the exterior of said housing.

19. The sensor cartridge of claim 18, fiber comprising a reference cell, and a third cell which reduces the amount of encasing material adjacent the flow channel, the third cell and the reference cell disposed symmetrically about the flow channel.

20. The sensor cartridge of claim 18, wherein the flow channel has a height of less than approximately 0.10 inch and a volume of approximately 0.05 milliliter.