Analyte sensors and methods of use

• US 9,097,660 B2
• Filed: 06/16/2014
• Issued: 08/04/2015
• Est. Priority Date: 12/22/2006
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wang, Yi
• Primary Examiner(s): LARKIN, DANIEL SEAN
• Application Number:
  US14/306,009
• Publication Number:
  US 20140299467A1
• Time in Patent Office: 414 Days
• Field of Search: 73/614.1, 738/647.3, 422/68.1, 204/403.1, 204/403.11, 204/403.12
• US Class Current: 1/1
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: C12Q 1/005 involving specific analytes or enzymes including groups of enzymes, e.g. oxydases; C12Q1/004 takes precedence
• CPC Class Codes: C12Q 1/006 for glucose
• 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 27/416 Systems G01N27/27 takes precedence
• CPC Class Codes: Y10T 156/1082 Partial cutting bonded sandwich [e.g., grooving or incising]

Abstract

Analyte sensors for determining the concentration of an analyte in a sample. The sensors have a sample chamber having an inlet with a projection extending from an edge of the sensor for facilitating flow of sample into the sample chamber.

Claims

1. A biosensor for determining the concentration of a biological analyte in a sample, the biosensor comprising:

a first substrate, a second substrate, and a spacer layer therebetween forming the biosensor, wherein the biosensor comprises a proximal end and a distal end;

a sample chamber defined between the first substrate and the second substrate bounded by the spacer layer at the proximal end of the biosensor, the sample chamber having a first inlet and a second inlet; and

a first protrusion extending from the first substrate at the first inlet and a second protrusion extending from the first substrate at the second inlet; and

wherein the proximal end has a width and the distal end has a width, and the width of the proximal end is less than the width of the distal end.

2. The biosensor of claim 1, further comprising a third protrusion extending from the second substrate at the first inlet.

3. The biosensor of claim 2, further comprising a fourth protrusion extending from the second substrate at the second inlet.

4. The biosensor of claim 1, wherein width of each of the protrusion is less than the width of the inlets.

5. A biosensor for determining the concentration of a biological analyte in a sample, the biosensor comprising:

a first substrate and a second substrate forming the biosensor, wherein the biosensor comprises a proximal end and a distal end;

a first side edge, a second side edge and an end edge;

a sample chamber defined between the first substrate and the second substrate at the proximal end of the biosensor, the sample chamber extending from the first side edge to the second side edge;

a first aperture and a second aperture between the first substrate and the second substrate at the first side edge and the second side edge, respectively; and

at least one protrusion extending from either the first side edge or the second side edge, proximate the apertures; and

wherein the proximal end has a width and the distal end has a width, and the width of the proximal end is less than the width of the distal end.

6. The biosensor of claim 5, comprising a first protrusion extending from the first side edge and a second protrusion extending from the second side edge.

7. The biosensor of claim 6, further comprising a third protrusion extending from the first side edge and a fourth protrusion extending from the second side edge, proximate the apertures.

8. The biosensor of claim 5, wherein the width of each of the at least one protrusion is less than the width of the proximate apertures.

9. The biosensor of claim 5, wherein the width of each of the at least one protrusion is no more than about 80% of the width of the proximate apertures.

10. The biosensor of claim 5, wherein the at least one protrusion has a height of at least about 0.2 mm.

11. The biosensor of claim 5, wherein the at least one protrusion is a triangle extending from the substrates.

12. A biosensor for determining the concentration of a biological analyte in a sample, the biosensor comprising:

a first substrate and a second substrate;

a spacer between the first substrate and the second substrate;

a sample chamber having only two inlets, a first inlet and a second inlet, the first inlet and the second inlet defined by the first substrate, second substrate, and spacer;

a first projection extending from a first edge of the biosensor at the first inlet, wherein the first projection is defined by the first substrate, and wherein a width of the first projection at the first edge of the biosensor is less than a width of the first inlet;

a second projection extending from a second edge of the biosensor at the second inlet, wherein the second projection is defined by the first substrate, and wherein a width of the second projection at the second edge of the biosensor is less than a width of the second inlet; and

a distal end having a width and a proximal end having a width, wherein the width of the distal end is less than the width of the proximal end, and the sample chamber is proximate the distal end of the biosensor.

13. The biosensor of claim 12, wherein the distal end of the biosensor comprises:

a portion of a first side edge of the biosensor;

a portion of a second side edge of the biosensor; and

an end edge of the biosensor, the end edge extending from the portion of the first side edge to the portion of the second side edge;

wherein the portion of the first side edge and the portion of the second side edge are recessed or reduced from a remainder of the first side edge and a remainder of the second side edge, respectively.

14. The biosensor of claim 13, wherein the portion of the first side edge and the portion of the second side edge are linear, curved or tapered.

15. The biosensor of claim 13, wherein the portion of the first side edge and the portion of the second side edge are linearly tapered.

16. The biosensor of claim 13, wherein the width of the first projection is approximately 80% of the width of the first inlet and the width of the second projection is approximately 80% of the width of the first inlet.

17. The biosensor of claim 13, the width of the first projection is approximately 50% of the width of the first inlet and the width of the second projection is approximately 50% of the width of the first inlet.

18. The biosensor of claim 13, wherein the first and second projections have a height of at least 0.2 mm.

19. The biosensor of claim 13, wherein the sample chamber has a volume of one microliter or less.

20. The biosensor of claim 13, wherein the biological analyte is glucose and the sample chamber comprises a glucose-responsive enzyme or a ketone-responsive enzyme.

21. The biosensor of claim 13, comprising a third projection extending from the second edge of the biosensor at the second inlet, wherein the third projection is defined by the second substrate, and wherein a width of the third projection is less than a width of the second inlet.

22. The biosensor of claim 21, comprising a fourth projection extending from the first edge of the biosensor at the first inlet, wherein the fourth projection is defined by the second substrate, and wherein a width of the fourth projection is less than a width of the first inlet.

23. The biosensor of claim 13, wherein the spacer comprises a first portion and a second portion, wherein the first portion is positioned at the distal end of the biosensor and the first portion is smaller than the second portion.