Methods for using a diagnostic test strip for collecting and detecting an analyte in a fluid sample

• US 20080220461A1
• Filed: 04/17/2008
• Published: 09/11/2008
• 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 7,678,580 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

1-29. -29. (canceled)

30. A method for lancing the skin of a test subject and harvesting a body fluid sample with a lancing and harvesting device, the method comprising the acts of:

providing a lancing and harvesting device having a test strip including a collection chamber, a containing ring surrounding the collection chamber, a capillary channel fluidly coupled to the collection chamber, and a lid disposed over the collection chamber and a least a portion of the capillary channel, the lancing and harvesting device further including a lancet configured to puncture the lid and to extend through the collection chamber when moving between a retracted position and an extended position;

placing the containing 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 sample from the collection chamber toward an inlet of the capillary channel.

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

32. The method of claim 31 wherein the 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.

33. The method of claim 32, wherein the analyte is glucose.

34. The method of claim 30, wherein the test strip further comprises a test area includes a top and a bottom, the test element extending from one of the top and bottom of the test area, the test element including the reagent thereon.

35. The method of claim 34, wherein the test strip further includes a vent extending from the test area.

36. The method of claim 30, wherein the body fluid is blood.

37. A method for lancing the skin of a test subject and harvesting a body fluid sample with a lancing and harvesting device having a test strip and a lancet, the method comprising the acts of:

placing a containing ring of the test strip on the skin of the test subject, the containing ring surrounding a collection chamber;

puncturing a lid with a lancet, the lid being disposed over the collection chamber and at least a portion of a capillary channel, the capillary channel being fluidly coupled to the collection chamber;

extending the lancet through the collection chamber;

lancing an area of the skin of the test subject bounded by a periphery of the containing ring to form a lance site;

maintaining the 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 sample from the collection chamber toward an inlet of the capillary channel.

38. The method of claim 37, further comprising measuring a concentration of an analyte in the collected body fluid sample.

39. The method of claim 38, wherein the measuring further comprises reacting the analyte in the collected body fluid sample with a reagent.

40. The method of claim 38, wherein the analyte is glucose.

41. The method of claim 37, wherein the test strip further includes a test area including a top and a bottom, the test area being in fluid communication with the capillary channel.

42. The method of claim 41, wherein the test area includes a test element extending from one of the top and bottom of the test area, the test element including a reagent thereon.

43. The method of claim 41, wherein the test strip further includes a vent extending from the test area.

44. The method of claim 37, wherein the test strip includes a base having a top and a bottom, the collection chamber extending from the bottom of the base, the containing ring being disposed on the bottom of the base.

45. A method for lancing the skin of a test subject and harvesting a body fluid sample with a lancing and harvesting device having a test strip and a lancet, the method comprising the acts of:

placing a containing ring of the test strip on the skin of the test subject, the containing ring being disposed on a bottom of a base of the test strip and surrounding a collection chamber, the collection chamber extending from the bottom of the base;

lancing an area of the skin of the test subject bounded by a periphery of the containing ring to form a lance site;

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;

directing, with a lid, at least a portion of the body fluid sample from the collection chamber toward an inlet of a capillary channel, the lid being attached to at least a portion of a top of the base, the lid covering at least a portion of the collection chamber, the capillary channel, and a test area fluidly connected to the capillary channel, the inlet of the capillary channel being fluidly coupled to the collection chamber, the capillary channel being positioned adjacent to the top of the base;

venting air from the test strip via a vent; and

measuring the concentration of an analyte in the collected body fluid sample by reacting the analyte in the collected body fluid sample with a reagent.

46. The method of claim 45, further comprising, prior to the act of lancing an area of the skin, puncturing the lid with the lancet.

47. The method of claim 45, wherein the test area includes a top and a bottom, the test element extending from one of the top and bottom of the test area, the test element including a reagent thereon.

48. The method of claim 45, wherein the analyte is glucose.

49. The method of claim 45, wherein the fluid sample is blood.