Electrochemical sensor and method thereof

• US 6,572,745 B2
• Filed: 12/07/2001
• Issued: 06/03/2003
• Est. Priority Date: 03/23/2001
• Status: Expired due to Term

• Current Assignee: Applied Biomedical, LLC
• Original Assignee: Virotek LLC
• Inventors: Rappin, Craig, Hajizadeh, Kiamars, Mills, Kelly
• Primary Examiner(s): Nguyen, Nam
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US10/017,751
• Publication Number:
  US 20020157947A1
• Time in Patent Office: 543 Days
• Field of Search: 204/403-1-4, 204/416, 204/431, 204/433, 204/434, 204/412
• US Class Current: 204/403.14
• 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. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions, comprising:

a unitary single piece body of molded plastic insulative material with a first end and an opposing second end;

at least two electrically conductive electrodes substantially molded into with at least a part thereof encased by the plastic, wherein the electrodes are disposed in fixed longitudinal relation in the insulative material;

means for connecting a meter to the body;

means for receiving a fluid sample;

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; and

,

one or more substances deposited on at least one of the electrodes to react with the fluid sample to produce electrochemical changes correlative to the concentration of an analyte in the sample.

2. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions, comprising:

a body of insulative material with a first end and an opposing second end comprising an electrode housing and an end cap pivotably attached to the electrode housing at the first end of the body with both the electrode housing and the end cap being molded plastic;

at least two electrically conductive electrodes disposed in fixed longitudinal relation in the insulative material;

means for connecting a meter to the body;

means for receiving a fluid sample;

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; and

one or more substances deposited on at least one of the electrodes to react with the fluid sample to produce electrochemical changes correlative t the concentration of an analyte in the sample.

3. The electrochemical device of claim 2 wherein the body has a hinge at the first end for permitting at least a portion of the body on one side of the hinge to pivot and connect onto a portion of the body on the other side of the hinge.

4. The electrochemical device of claim 3 further comprising at least one ridge and one recessed surface, each formed in the device on opposite sides of the hinge, such that when the body is pivoted about the hinge, said ridge and said recessed surface mate to form a reaction zone.

5. The electrochemical device of claim 2 further comprising at least one protuberance formed on at last one of the housing and the end cap, such that the end cap may be pivoted onto the housing and securedly attached thereto to form a reaction zone in the body.

6. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions, comprising:

a unitary single piece body of insulative material with a first end and an opposing second end;

at least two electrically conductive electrodes disposed in fixed longitudinal relation with at least a part thereof encased by the insulative material;

a plug formed at the second end of the body for connecting a meter to the body;

means for receiving a fluid sample;

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; and

,

one or more substances deposited on at least one of the electrodes to react with the fluid sample to produce electrochemical changes correlative to the concentration of an analyte in the sample.

7. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions comprising:

a unitary single piece body of insulative material with a first end and an opposing second end;

at least two electrically conductive electrodes disposed in fixed longitudinal relation with at least a part thereof encased by the insulative material;

means for connecting a meter to the body;

a capillary inlet molded into the first end for drawing the fluid sample into the body upon contact with the sample;

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; and

,

one or more substances deposited on at least one of the electrodes to react with the fluid sample to produce electrochemical changes correlative to the concentration of an analyte in the sample.

8. The electro chemical device of claim 7 further comprising a reaction zone formed in the body in communication with the capillary inlet.

9. The electrochemical device of claim 8 wherein the reaction zone is a channel containing at least a portion of each of the electrodes for analyzing the fluid sample drawn therein.

10. The electrochemical device of claim 9 wherein the means for detecting when a sufficient amount of fluid sample has been received includes a depressurization vent formed in the body in communication with the reaction zone.

11. The electrochemical device of claim 9 wherein the means for detecting when a sufficient amount of fluid sample has been received includes a sample fill vent in the body in communication with the reaction zone for filling with sample fluid and allowing for fill detection to be made visually.

12. The electrochemical device of claim 9 having an end cap pivotably attached to the body near the first end, the end cap having a sample fill vent that when the end cap is attached to the body, the sample fill vent substantially aligns with at least one of the electrodes.

13. The electrochemical device of claim 9 wherein the reaction zone lies in the bottom portion of the device.

14. The electrochemical device of claim 8 wherein the at least two electrodes terminate in the reaction zone, the reaction zone having a vent for relieving pressure.

15. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions, comprising:

a unitary single piece body of insulative material with a first end and an opposing second end;

at least two electrically conductive wires disposed in fixed longitudinal relation with a part thereof encased by the insulative material;

means for connecting a meter to the body;

means for receiving a fluid sample;

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; and

one or more substances deposited on at least one of the conductive wires to react with the fluid sample to produce electrochemical changes correlative to the concentration of an analyte in the sample.

16. The electrochemical device of claim 15 wherein at least one wire is coated with a conductive material different then the composition of the wire.

17. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a insult of chemical or enzymatic reactions, comprising:

a unitary single piece body of insulative material with a first end and an opposing second end;

at least two electrically conductive electrodes formed from a conductive plate disposed in fixed longitudinal relation with a part thereof encased by the insulative material;

means for connecting a meter to the body;

means for receiving a fluid sample;

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; and

,

one or more substances deposited on at least one of the electrodes to react with the fluid sample to produce electrochemical changes correlative to the concentration of an analyte in the sample.

18. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions, comprising:

a unitary single piece body of insulative material with a first end and an opposing second end;

at least two electrically conductive electrodes disposed in fixed longitudinal relation with a part thereof encased by the insulative material;

means for connecting a meter to the body;

means for receiving a fluid sample;

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; and

,

one or more substances deposited on at least one of the electrodes to react with the fluid sample to produce electrochemical changes correlative to the concentration of an analyte in the sample, the substance including a coating on at least one electrode with at least one of a reagent and an enzyme.

19. An electrochemical device for cooperating with a meter to measure changes in electrochemical properties of a fluid sample as a result of chemical or enzymatic reactions, comprising:

a body of insulative material with a first end and an opposing second end;

at least two electrically conductive electrodes disposed in fixed longitudinal relation in the insulative material;

means for connecting a meter to the body;

means for receiving a fluid sample;

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; and

,

an enzyme on an outer surface of one of the electrodes and one of an enzyme-antibody conjugate and an enzyme-analyte conjugate is on another of the electrodes.

20. The electrochemical device of claim 19 wherein an electron mediator is on one or more of the electrodes.

21. An electrochemical device for cooperating with an electronic meter capable of measuring the electrochemical properties in a fluid sample resulting from chemical or enzymatic reaction, comprising:

a body of insulative material with a first end and a second end;

three electrically conductive electrodes spaced apart in fixed longitudinal relation to each other, housed in the body, the body including an electrode encasing unit and an end cap attached to one another with each being made of molded plastic;

a plug for connecting a meter to the body;

means for receiving a fluid sample in the body; and

,

means for detecting when a sufficient amount of fluid sample has been received for analysis selected from the group consisting of (a) an electrical indication and (b) a visual indication.

22. An electrochemical device for cooperating with an electronic meter capable of measuring the electrochemical properties in a fluid sample resulting from chemical or enzymatic reaction, comprising:

a unitary single piece body of insulative material with a first end and a second end;

three electrically conductive electrodes spaced apart in fixed longitudinal relation to each other with a part thereof encased by the body;

a plug for connecting a meter to the body;

a capillary inlet for drawing the fluid sample into the body upon contact with the fluid sample; and

,

means for detecting when a sufficient amount of fluid sample has been received for analysis selected from the group consisting of (a) an electrical indication and (b) a visual indication.

23. The electrochemical device of claim 22 further having

a hinge constructed in the body permitting the pivoting and connecting of a portion of the body onto itself; and

at least one energy director ridge formed in the body on at least one side of the hinge, such that securedly affixing the energy director ridge to the body opposite side of hinge forms a reaction zone.

24. The electrochemical device of claim 23 further comprising one or more substances an one or more electrodes for reacting with the fluid sample to produce electrochemical changes measurable by the electrodes.

25. The electrochemical device of claim 23 wherein the one or more substances is a coating on at least one electrode with at least one of a reagent and an enzyme.

26. The electrochemical device of claim 23 wherein an enzyme is on the outer surface of one of the electrodes.

27. The electrochemical device of claim 26 wherein an electron mediator is on the outer surface of one or more of the electrodes.

28. The electrochemical device of claim 22 having

a hinge constructed in the body permitting the pivoting and connecting of a portion of the body onto itself;

and

at least one protuberance formed in the body on one side of the hinge to mate with at least one recessed surface in the body on the other side of the hinge.

29. The electrochemical device of claim 28 further comprising one or more substances on one or more electrodes for reacting with the fluid sample to produce electrochemical changes measurable by the electrodes.

30. The electrochemical device of claim 28 wherein the one or more substances is a coating on at least one electrode with at least one of a reagent and an enzyme.

31. The electrochemical device of claim 28 wherein an enzyme is on the outer surface of one of the electrodes.

32. The electrochemical device of claim 31 wherein an electron mediator is on the outer surface of one or more of the electrodes.

33. An electrochemical device for cooperating with an electronic meter capable of measuring the electrochemical properties in a fluid sample resulting from chemical or enzymatic reaction, comprising:

a body of insulative material with a first end and a second end;

three electrically conductive electrodes spaced apart in fixed longitudinal relation to each other, housed in the body;

a plug for connecting a meter to the body;

means for receiving a fluid sample in the body; and

,

a cavity forming a reaction zone in the body, the reaction zone having at least a portion of each electrode exposed therein for reacting with the fluid sample, such that sample drawn into the reaction zone contacts the exposed portion of at least one of the electrodes and activates the meter to indicate sufficient fill.

34. The electrochemical device of claim 33 wherein the reaction zone is in fluid communication with a capillary inlet.

35. An electrochemical device for cooperating with an electronic meter capable of measuring the electrochemical properties in a fluid sample resulting from chemical or enzymatic reaction, comprising:

a unitary single piece body of insulative material with a first end and a second end;

three electrically conductive electrodes spaced apart in fixed longitudinal relation to each other with a part thereof encased by the body, the electrodes being one of isolated conductive wires and wires associated with a conductive plate;

a plug for connecting a meter to the body;

means for receiving a fluid sample in the body; and

,

means for detecting when a sufficient amount of fluid sample has been received for analysis selected from the group consisting of (a) an electrical indication and (b) a visual indication.

36. An electrochemical device for measuring the concentration of an analyte by cooperating with an electronic meter capable of measuring the electro chemical properties of a fluid sample resulting from chemical or enzymatic reaction, comprising:

a unitary, single molded plastic body with two opposing ends;

at least two spaced apart electrically conductive electrodes with a part thereof encased by the molded body;

a plug formed at one end of the body exposing the electrodes outside the body for connecting the meter to the body;

an inlet molded into the other end of the body defining a capillary for drawing the fluid sample into the body upon contact with the fluid sample;

a reaction zone in communication with the capillary, there action zone having an interior surface and at least a portion of each electrode exposed therein for reacting with the fluid sample, such that sample drawn into the reaction zone contacts the exposed portion of at least one electrode and activates the meter to indicate sufficient fill; and

one or more substances on at least one of the interior surface of the reaction zone and at least one of the electrodes such that the one or more substances react with the fluid sample to produce electrochemical changes measurable by the meter.

37. The electrochemical device of claim 36 wherein the reaction zone has a volume defined by the shape of at least one of the body and an end cap securedly affixable to the body.

38. The electrochemical device of claim 36 wherein the electrodes are embedded in the body as one of isolated conductive wires and a composite conductive plate.

39. The electrochemical device of claim 36 having

a hinge constructed in the body permitting the pivoting and connecting of a portion of the body onto itself; and

at least one protuberance formed in the body on one side of the hinge to mate with at least one recessed surface in the body on the other side of the hinge to form the reaction zone.

40. The electrochemical device of claim 36 having

a hinge constructed in the body permitting the pivoting and connecting of a portion of the body onto itself;

and

at least one energy director ridge formed in the body on one side of the hinge and securedly affixable to the body on the opposite side of the hinge to form the reaction zone.

41. The electrochemical device of claim 36 wherein the one or more substances comprises a coating having at least an enzyme.

42. The electrochemical device of claim 41 wherein the coating includes one of an enzyme-antibody conjugate and an enzyme-analyte conjugate.

43. The electrochemical device of claim 41 wherein the coating includes an electron mediator.

44. A sensor comprising:

a body having an end for cooperating with a meter and an end for receiving a fluid sample;

a plurality of electrically conductive leads with a part thereof around which a portion of the body has been molded so as to be encased by the body and having at least one lead extending into the end for receiving the fluid sample;

a cavity in the body to detect sufficiency of sample quantity; and

,

an enzyme deposited on at least one of the leads.

45. The sensor of claim 44 wherein the body is formed from a moldable material and made in a mold.

46. The sensor of claim 44 wherein the leads are at least partially exposed at the end for cooperating with the meter.

47. The sensor of claim 44 wherein the cavity is formed in the lower portion of the body and communicates with the end for receiving the fluid sample, such that the fluid sample contacts a portion of the leads to produce a measurable change in the fluid.

48. The sensor of claim 44 wherein at least one of the leads is a wire conductor.

49. The sensor of claim 44 wherein at least one of the leads is a stamped conductive metal member.

50. The sensor of claim 49 wherein the stamped conductive metal member is coated with another electrically conductive material.

51. The sensor of claim 44 wherein at least two of the plurality of the leads include different metals.

52. The sensor of claim 44 wherein the body has a plurality of guides molded therein to prevent the leads from moving within the body.

53. The sensor of claim 44 wherein the end for receiving a fluid sample includes a capillary inlet.

54. The sensor of claim 53 wherein the capillary inlet is in communication with the cavity for detecting sufficient fill.

55. A sensor comprising:

an injection molded plastic body having a meter-attachment end and a fluid sample receiving cavity;

a plurality of electrically conductive leads with a part thereof encased by the body and with at least one lead extending from the attachment end to the fluid sample receiving cavity;

a plurality of vents communicating with the fluid sample receiving cavity for detecting the sufficiency of the amount of the fluid sample received; and

,

an enzyme disposed within the fluid sample receiving cavity.

56. The sensor of claim 55 wherein the cavity and the leads are in a bottom portion of the sensor, such that the sample contacts the edges of the leads to produce a measurable electrical change in the fluid.

57. The sensor of claim 55 wherein the leads are at least partially expose at the attachment end of the molded body.

58. The sensor of claim 55 wherein at least one of the leads is a stamped conductive metal member.

59. The sensor of claim 55 wherein the stamped conductive metal member is coated with an electrically conductive material different than the composition of the lead.

60. The sensor of claim 55 wherein the body has a plurality of guides molded therein to hold and maintain the leads within the body.

61. The sensor of claim 55 wherein the enzyme is disposed on at least one of the leads.

62. A sensor for analyzing a fluid sample comprising:

an injection molded body having an attachment end and a sample receiving zone;

a plurality of electrically conductive leads with at least a part thereof encased by the body, the leads extending in substantial alignment between the two ends, at least one of the leads extending into the sample receiving zone and the body having a plurality of guides molded therein with at least one of the guides abutting against at least one of the leads;

a substance deposited within the sample receiving zone for analyzing the fluid sample; and

,

a vent communicating with the sample receiving zone for determining adequate sample fill.