Diagnostic test strip for collecting and detecting an analyte a fluid sample and method for using same

• US 20050136501A1
• Filed: 05/10/2004
• Published: 06/23/2005
• Est. Priority Date: 05/29/2003
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Kuriger, Rex J.
• Granted Patent: US 7,374,949 B2
• Time in Patent Office: Days
• US Class Current: 435/14
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15192 comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/417 the bone marrow
• CPC Class Codes: Y10T 436/25 including sample preparation
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

A test strip for use of the determination of an analyte in a fluid sample according to one embodiment of the present invention is disclosed. The test strip comprises a base having a top and a bottom, a collection chamber that extends between the top and the bottom of the base, a containing ring that is disposed on the bottom of the base and surrounds the collection chamber, and a capillary channel formed in top of the base that has an inlet fluidly coupled to the collection chamber, a test element disposed within the capillary channel. A lid is attached to the top of the base and covers the collection chamber, the test membrane, and at least a portion of the capillary channel.

Claims

1. A test strip for use in the determination of an analyte in a fluid sample, the test strip comprising:

a base having a top and a bottom;

a collection chamber extending between the top and the bottom of the base;

a containing ring disposed on the bottom of the base, the containing ring surrounding the collection chamber;

a capillary channel formed in top of the base, the capillary channel having an inlet fluidly coupled to the collection chamber;

a test element disposed within the capillary channel; and

a lid attached to the top of the base, the lid covering the collection chamber, the test membrane, and at least a portion of the capillary channel.

2. The test strip of claim 1 wherein the lid is constructed of a substantially optically clear material.

3. The test strip of claim 1 wherein the lid is constructed of a substantially nonporous material.

4. The test strip of claim 1 wherein the test element include a reagent for producing a reaction indicative of the concentration of the analyte in the fluid sample.

5. The test strip of claim 4 wherein the analyte is glucose.

6. The test strip of claim 4 wherein the sample is blood.

7. The test strip of claim 1 in combination with a lancing device.

8. The test strip of claim 1 comprising a hydrophilic coating disposed on at least a portion of the capillary channel.

9. The test strip of claim 1 wherein the test element is attached to the lid.

10. The test strip of claim 9 wherein the test element is attached to the lid with a substantially optically clear adhesive.

11. The test strip of claim 1 wherein the capillary channel includes a test area for receiving the test element, a transverse dimension of the test area being greater than a transverse dimension of the test element.

12. The test strip of claim 1 wherein the capillary channel includes a test area for receiving the test element, a depth of the test area being greater than a thickness of the test element.

13. The test strip of claim 1 wherein the containing ring outwardly extends from the bottom of the base.

14. A device for use in the determination of an analyte in a body fluid, the device including a lancing assembly having a lancet for puncturing the skin of a test subject, the lancet being adapted to move between a retracted position and an extended position for puncturing the skin of a test subject, the device comprising:

an end cap removably attached to the lancing device, the end cap having a rim for contacting the skin of the test subject, the lancet extending beyond the rim of the end cap when in the extended position; and

a test strip disposed within the end cap, the test strip including a collection chamber and a capillary channel fluidly coupled to the collection chamber, the test strip including a test element disposed within the capillary channel, the test element in fluid communication with the collection chamber, the test strip including a lid disposed over the collection chamber and a least a portion of the capillary channel, the lancet puncturing the lid and extending through the collection chamber when moving between the retracted position and the extended position.

15. The device of claim 14 wherein the test strip includes a containing ring outwardly extending from a bottom of the test strip for contacting a test subject'"'"'s skin.

16. The device of claim 14 wherein the lancing assembly is vacuum assisted.

17. The device of claim 14 wherein the lid of the test strip is constructed of a substantially optically clear material.

18. The test strip of claim 14 wherein the lid is constructed of a substantially nonporous material.

19. The device of claim 14 wherein the test element of the test strip includes a reagent for producing a reaction indicative of the concentration of the analyte in the fluid sample.

20. The device of claim 19 wherein the analyte is glucose.

21. The device of claim 19 wherein the sample is blood.

22. The device of claim 19 wherein the reagent produces a colorimetric reaction, the device comprising an optical device for reading the reaction.

23. The device of claim 19 wherein the reagent produces an electrochemical reaction, the device comprising a meter for measuring the reaction.

24. The device of claim 14 comprising a hydrophilic coating disposed on at least a portion of the capillary channel of the test strip.

25. The device of claim 14 wherein the test element is attached to the lid of the test strip.

26. The device of claim 25 wherein the test element is attached to the lid of the test strip with a substantially optically clear adhesive.

27. The device of claim 14 wherein the capillary channel of the test strip includes a test area for receiving the test element, a transverse dimension of the test area being greater than a transverse dimension of the test element.

28. The device of claim 14 wherein the capillary channel of the test strip includes a test area for receiving the test element, a depth of the test area being greater than a thickness of the test element.

29. The device of claim 14 wherein the test element of the test strip includes a reagent for producing a reaction indicative of the concentration of the analyte in the fluid sample.

30. A method for lancing the skin of a test subject and harvesting a body fluid sample with a lancing and harvesting device, the lancing and harvesting device having a test strip including a collection chamber, a containing ring surrounding the collection area, a capillary channel fluidly coupled to the collection area, and a lid disposed over the collection chamber and a least a portion of the capillary channel, the lancing and harvesting device having a lancet adapted to puncturing the lid and to extended through the collection chamber when moving between the retracted position and the extended position, the method comprising:

placing the collection ring of the test strip on the skin of the test subject;

lancing an area of the skin of the test subject bounded by the periphery of the containing ring;

maintaining a body fluid sample produced at the lance site within the periphery of the containing ring;

collecting the body fluid sample produced at the lance site with the test strip; and

directing, with the lid, at least a portion of the body fluid from the collection chamber toward an inlet of the capillary channel.

31. The method of claim 30 comprising measuring the concentration of an analyte in the collected body fluid sample.

32. The method of claim 31 wherein measuring further comprises reacting the analyte in the collected body fluid sample with a reagent, the reagent being disposed on a test element received in the capillary channel of the test strip.