Method of making sensor

• US 6,849,216 B2
• Filed: 04/21/2003
• Issued: 02/01/2005
• Est. Priority Date: 03/23/2001
• Status: Expired due to Term

• Current Assignee: Applied Biomedical, LLC
• Original Assignee: Virotek LLC
• Inventors: Hajizadeh, Kiamars, Mills, Kelly, Rappin, Craig
• Primary Examiner(s): ORTIZ, ANGELA Y
• Application Number:
  US10/419,581
• Publication Number:
  US 20030201176A1
• Time in Patent Office: 652 Days
• Field of Search: 264/134, 264/259, 264/261, 264/254, 264/265, 264/271.1, 264/272.11, 264/277, 204/403.01, 204/403.02, 204/403.14, 204/416, 174/126.1, 174/128.1, 174/130, 174/110.R, 174/113.R, 174/100.SR
• US Class Current: 264/134
• 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 reaction zone by forming a channel with the mold;

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; and

,

forming apertures in the body by holding the at least two electrodes in place during the molding step using fingers passing through the body.

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 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.

4. 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.

5. 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.

6. 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.

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

8. The method of claim 7 wherein the means for receiving the fluid sample includes a capillary inlet in the body in communication with a reaction zone and a vent.

9. 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.

10. 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.

11. 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 reaction zone by forming a channel with the mold;

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; and

forming apertures in the body by holding the at least two electrodes in place during the molding step using fingers passing through the body.

12. The method of claim 11 wherein the molding step includes molding a body of insulative material to at least encase at least a portion of the electrodes.

13. The method of claim 11 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.

14. The method of claim 11 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.

15. The method of claim 11 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.

16. The method of claim 11 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.

17. The method of claim 11 wherein the body is molded with a means for connecting a meter to the body and a means far receiving a fluid sample.

18. The method of claim 11 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.

19. 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 reaction zone by forming a channel with the mold, the molding step forming a hinge in the body for permitting the pivoting and connecting of a portion of the body onto itself; 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.

20. The method of claim 19 wherein the molding step includes molding insulative material to at least encase at least a portion of the electrodes.

21. The method of claim 19 wherein the electrodes are held in place during the molding step by fingers passing through apertures formed in the body.

22. The method of claim 19 further comprising severing a connecting segment via an aperture formed in the body, the connecting segment electrically connecting the at least two spaced apart electrically conductive electrodes prior to severing the connecting segment.

23. 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, the molding step 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; 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.

24. The method of claim 23 wherein the molding step includes molding insulative material to at least encase at least a portion of the electrodes.

25. The method of claim 23 wherein the electrodes are held in place during the molding step by fingers passing through apertures formed in the body.

26. The method of claim 23 further comprising severing a connecting segment via an aperture formed in the body, the connecting segment electrically connecting the at least two spaced apart electrically conductive electrodes prior to severing the connecting segment.

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

positioning a first electrode and a second electrode in a mold;

molding a body of insulative material within the mold to embed a first portion of the first electrode and a first portion of the second electrode in the insulative material and to permit exposure of a second portion of the first electrode and a second portion of the second electrode; and

forming apertures in the body by holding the first electrode and the second electrode in place during the molding step using projections passing through the body.

28. The method of claim 27 wherein the molding step includes molding insulative material to at least encase at least a portion of the first electrode and the second electrode.

29. The method of claim 27 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.

30. The method of claim 27 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.

31. The method of claim 27 further comprising severing a connecting segment via an aperture formed in the body, the connecting segment electrically connecting the first electrode and the second electrode prior to severing the connecting segment.

32. The method of claim 27 further comprising:

coating at least a portion of the first electrode with a reagent and an enzyme; and

,

coating at least a portion of the second electrode with the reagent and not the enzyme.

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

positioning a conductive plate including a first electrode, a second electrode, and a connecting segment electrically connecting the first electrode and the second electrode in a mold;

molding a body of insulative material within the mold to embed a first portion of the first electrode and a first portion of the second electrode in the insulative material and to permit exposure of a second portion of the first electrode and a second portion of the second electrode;

severing the connecting segment via art aperture formed in the body; and

,

treating the first electrode with a substance for reacting with the fluid sample to be tested.

34. The method of claim 33 wherein the first electrode and the second electrode are held in place during the molding step by fingers passing through apertures formed in the body.

35. The method of claim 33 wherein the molding step includes forming a hinge the body for permitting the pivoting and connecting of a portion of the body onto itself.

36. The method of claim 33 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.

40. The method of claim 33 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.

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

positioning a first electrode and a second electrode in a mold;

molding a body of insulative material within the maid to embed a first portion of the first electrode and a first portion of the second electrode in the insulative material and to permit exposure of a second portion of the first electrode and a second portion of the second electrode;

coating at least a portion of the first electrode with a reagent and an enzyme; and

,

coating at least a portion of the second electrode with the reagent and not the enzyme.

38. The method of claim 37 wherein the first electrode and second electrode are held in place during the molding step by fingers passing through apertures formed in the body.

39. The method of claim 37 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.

41. The method of claim 37 further comprising severing a connecting segment via an aperture formed in the body, the connecting segment electrically connecting the first electrode and the second electrode prior to severing the connecting segment.