Method of making sensor

• US 20030201176A1
• Filed: 04/21/2003
• Published: 10/30/2003
• Est. Priority Date: 03/23/2001
• Status: Active Grant

• Current Assignee: Applied Biomedical, LLC
• Original Assignee: Craig Rappin, Kelly Mills, Kiamars Hajizadeh
• Inventors: Rappin, Craig, Hajizadeh, Kiamars, Mills, Kelly
• Granted Patent: US 6,849,216 B2
• Time in Patent Office: Days
• US Class Current: 204/403.01
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

A sensor is provided for the determination of various concentrations of one or more components within a fluid sample. The sensor includes an injection molded body, at least two electrodes, an enzyme, and if desired, an electron transfer mediator. The body includes a reaction zone for receiving a fluid sample. The electrodes are at least partially embedded within the plastic body and extend into the reaction zone. Also contained within the reaction zone is an enzyme capable of catalyzing a reaction involving a compound within the fluid sample. Additionally, the sensor incorporates fill detection which activates a meter, attached to the sensor, for measuring the electrochemical changes occurring in the reaction zone.

Claims

1. A method of making a testing device for testing a fluid sample comprising the steps of:

positioning at least two spaced apart electrically conductive electrodes in a mold;

molding a body within the mold of insulative material to at least embed a part of the electrodes in the insulative material and to permit exposure of at least a portion of one electrode to a fluid sample to be tested; and

,

treating at least one of the electrodes with one or more substances before or after the molding of the body for reacting with the fluid sample to be tested.

2. The method of claim 1 wherein the molding step includes molding a body of insulative material to at least encase at least a portion of the electrodes.

3. The method of claim 1 wherein the electrodes are held in place during the molding step.

4. The method of claim 1 wherein the electrically conductive electrodes are substantially molded into the insulative material with at least a part thereof embedded within the insulative material and the electrodes are disposed in fixed longitudinal relation in the insulative material.

5. The method of claim 1 wherein the electrically conductive electrodes are substantially molded into the insulative material with at least a part thereof encased by the insulative material and the electrodes are disposed in fixed longitudinal relation in the insulative material.

6. The method of claim 1 wherein the molding step includes forming a hinge in the body for permitting the pivoting and connecting of a portion of the body onto itself.

7. The method of claim 1 wherein the molding step comprises molding the body in two pieces, an electrode-encasing housing and an end cap, both of the pieces being hingeably attachable to one another after the molding is completed.

8. The method of claim 1 wherein the molding step includes molding into the body a means for receiving the fluid sample.

9. The method of claim 8 wherein the means for receiving the fluid sample includes a capillary inlet in the body in communication with a reaction zone and a vent.

10. The method of claim 1 wherein the molding step includes forming a vent in the body for detecting when the sensor contains a sufficient quantity of fluid sample for testing.

11. The method of claim 1 wherein the molding step includes molding into the body a means for detecting the presence of an adequate amount of sample.

12. A method of making an electrochemical device for cooperating with a meter to measure electrical properties between at least two electrically conductive electrodes, comprising the steps of:

positioning at least two spaced apart electrically conductive electrodes in a mold;

molding a body within the mold of insulative material to at least embed a portion of the electrodes in the insulative material and to permit exposure of at least a portion of one electrode to a fluid sample to be tested; and

,

depositing one or more substances on at least one of the electrodes before or after the molding of the body to react with the fluid sample to be tested and to change the electrical properties between the electrodes.

13. The method of claim 12 wherein the molding step includes molding a body of insulative material to at least encase at least a portion of the electrodes.

14. The method of claim 12 wherein the electrodes are held in place during the molding step.

15. The method of claim 12 wherein the electrically conductive electrodes are substantially molded into the insulative material with at least a part thereof embedded within the insulative material and the electrodes are disposed in fixed longitudinal relation in the insulative material.

16. The method of claim 12 wherein the electrically conductive electrodes are substantially molded into the insulative material with at least a part thereof encased by the insulative material and the electrodes are disposed in fixed longitudinal relation in the insulative material.

17. The method of claim 12 wherein the molding step includes forming a hinge in the body for permitting the pivoting and connecting of a portion of the body onto itself.

18. The method of claim 12 wherein the molding step comprises molding the body in two pieces, an electrode-encasing housing and an end cap, both of the pieces being hingeably attachable to one another after the molding is completed.

19. The method of claim 12 wherein the body is molded with a means for connecting a meter to the body and a means for receiving a fluid sample.

20. The method of claim 12 wherein the body is molded to further include a means for detecting when a sufficient amount of fluid sample has been received selected from the group consisting of (a) an electrical indication and (b) a visual indication.