BIOSENSOR WITH PREDETERMINED DOSE RESPONSE CURVE AND METHOD OF MANUFACTURING

• US 20100243441A1
• Filed: 03/30/2009
• Published: 09/30/2010
• Est. Priority Date: 03/30/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Groll, Henning
• Granted Patent: US 8,608,937 B2
• Time in Patent Office: Days
• US Class Current: 204/403.10
• CPC Class Codes: B29C 65/74 by welding and severing , or by joining and severing, the severing being performed in the area to be joined, next to the area to be joined, in the joint area or next to the joint area
• 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: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

The present invention provides a system of biosensors whose dose-response curves are maintained within a predetermined and desired range or tolerance during production by selecting a feature of the biosensors that can be varied during production. For example, in one exemplary embodiment the effective area of the working electrode of an electrochemical biosensor can be varied during production as needed to offset variations that occur, e.g., in the reagent of the biosensors as production proceeds. In another exemplary embodiment, the dose-response curve of biosensors not yet produced can be predicted and one or more features of these biosensors can be selected to maintain the dose-response curve within a predetermined range or tolerance.

Claims

1-34. -34. (canceled)

35. A system of electrochemical biosensors, comprising:

first and second biosensors of the same model, the first biosensor having a first electrical pattern including a first plurality of adjustment fingers and the second biosensor having a second electrical pattern including a second plurality of adjustment fingers;

the first and second electrical patterns having different numbers of their respective adjustment fingers electrically disconnected and thereby having different effective areas; and

wherein the dose-response curves of the first and second biosensors are within a common predetermined range.

36. The system of claim 35, wherein the first and second electrical patterns each comprise working and counter electrodes, wherein the working electrode of the first electrical pattern has an effective area that is different than the effective area of the working electrode of the second electrical pattern.

37. The system of claim 36, wherein the working electrodes of the first and second electrical patterns comprise the first and second pluralities of adjustment fingers, respectively, at least one of the fingers of the first electrical pattern being electrically disconnected.

38. The system of claim 37, wherein a reagent covers a portion of the working electrodes and the at least one finger is severed in a location spaced from the portion of the working electrodes that is covered by the reagent.

39. The system of claim 35, wherein the first and second biosensors each comprise:

a substrate, the substrate of the first biosensor having the first electrical pattern formed thereon and the substrate of the second biosensor having the second electrical pattern formed thereon, the first and second electrical patterns each comprising a working electrode, a counter electrode and contacts configured to connect the biosensors to a meter;

one or more of a spacing layer and a covering layer overlying the substrate and cooperating with the substrate to define a sample receiving chamber; and

a reagent disposed in the sample receiving chamber and contacting at least a portion of the working electrode.

40. The system of claim 39, wherein the substrate, the one or more of a spacing layer and a covering layer, and the reagent are all substantially identical in the first and second biosensors.

41. The system of claim 39, wherein the one or more of the spacing layer and covering layer comprise an opening through which a section of the first and second electrical patterns can be accessed during production.

42. The system of claim 35, further comprising a third biosensor having a third electrical pattern, the first and third electrical patterns being identical, wherein the dose-response curves of the first, second and third biosensors are within the same predetermined range.

43. The system of claim 35, further comprising a third biosensor having a third electrical pattern having a third plurality of adjustment fingers, the first, second and third pluralities of fingers each comprising a different number of electrically disconnected fingers, wherein the dose-response curves of the first, second and third biosensors are within the same predetermined range.

44. The system of claim 35, wherein the first biosensor and the second biosensor are produced in different production lots.

45. The system of claim 35, wherein the first biosensor and the second biosensor are produced in the same production lot.

46. A method of manufacturing electrochemical biosensors of the same model, the biosensors each having an electrical pattern comprising several adjustment fingers which can be individually disconnected from or connected to the electrical pattern to adjust the effective area of the electrical pattern, the method comprising:

(a) producing first and second biosensors;

(b) determining the dose-response curve of the first biosensor;

(c) selecting the effective area of the electrical pattern of the second biosensor as a function of the dose-response curve of the first biosensor; and

(d) connecting or disconnecting at least one of the several adjustment fingers of the second biosensor to achieve the selected effective area, wherein the dose-response curve of the second biosensor falls within a desired predetermined range.

47. The method of claim 46, wherein the first and second biosensors are produced in the same production lot.

48. The method of claim 46, further comprising roll to roll processing, wherein the first and second biosensors are located on different rolls during production.

49. The method of claim 46, wherein the first and second biosensors are produced in different production lots.

50. The method of claim 46, wherein step (d) comprises electrically disconnecting at least one of the several adjustment fingers in the second biosensor.

51. The method of claim 50, wherein the electrically disconnected adjustment finger comprises a segment of a working electrode.

52. The method of claim 51, wherein the electrically disconnected adjustment finger is positioned at least partially within a capillary chamber of the second biosensor.

53. The method of claim 46, wherein the adjustment fingers extend into a capillary chamber.

54. The method of claim 46, wherein step (b) is performed before the electrical pattern is formed on the second biosensor.

55. The method of claim 46, further comprising:

providing the electrical pattern of the second biosensor on a substrate; and

laminating at least one covering layer or a spacing layer over the substrate, thereby forming a cover and a sample receiving chamber on the second biosensor.

56. The method of claim 55, wherein step (d) comprises penetrating the at least one covering layer or a spacing layer to sever the at least one of the several adjustment fingers of the electrical pattern of the second biosensor.

57. The method of claim 56, wherein the severing is performed with a laser.

58. The method of claim 46, wherein step (b) comprises destructive testing of the first biosensor.

59. A method of manufacturing electrochemical biosensors of the same model, comprising:

(a) producing a first biosensor having a first electrical pattern with a first effective area;

(b) determining a dose-response curve of the first biosensor;

(c) using the dose-response curve determined for the first biosensor to determine a second effective area for a second electrical pattern of a second biosensor, the second effective area being different from the first effective area; and

(d) forming the second biosensor, the second effective area being obtained during formation of the second electrical pattern, wherein the second biosensor has a dose-response curve that is within a desired predetermined range.

60. The method of claim 59, wherein step (a) comprises forming a first working electrode of the first biosensor with a first width and step (d) comprises forming a second working electrode of the second biosensor with a second width that is different from the first width.

61. The method of claim 60, wherein step (a) comprises forming the first working electrode and a first counter electrode with a gap therebetween and step (d) comprises maintaining the same size of the gap in the second biosensor.

62. The method of claim 60, wherein step (a) comprises forming the first working electrode and a first counter electrode with a first gap therebetween and step (d) comprises forming the second working electrode and a second counter electrode with a second gap therebetween, the second gap having a different size than the first gap.

63. The method of claim 59, wherein:

the first biosensor comprises a plurality of first biosensors;

the dose-response curve determined in step (b) comprises an average dose-response curve of the plurality of first biosensors; and

the second biosensor comprises a plurality of second biosensors.

64. The method of claim 63, further comprising:

determining an average dose-response curve of the plurality of second biosensors;

determining a third effective area for a third electrical pattern for a plurality of third biosensors, the third effective area being different from the second effective area; and

forming the plurality of third biosensors with the third electrical patterns having the third effective area, wherein the plurality of third biosensors has a dose-response curve that is within the desired predetermined range.

65. The method of claim 64, wherein the first and third effective areas are the same.

66. The method of claim 63, wherein the plurality of first biosensors comprises a first production lot of biosensors and the plurality of second biosensors comprises a second production lot of biosensors.

67. The method of claim 63, further comprising establishing upper and lower control limits which define the desired predetermined range.