Sensor with integrated lancet

• US 20040248312A1
• Filed: 06/06/2003
• Published: 12/09/2004
• Est. Priority Date: 06/06/2003
• Status: Abandoned Application

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Flora, Bruce A., McCleary, Alan R., Charlton, Steven C., Vreeke, Mark S.
• Application Number:
  US10/455,012
• Publication Number:
  US 20040248312A1
• Time in Patent Office: Days
• US Class Current: 436/95
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A fluid collection apparatus adapted to test a concentration of an analyte in a fluid, including a lid and a base. Further included is a spacer disposed between the lid and the base. The spacer forms a capillary channel, which has an opening and is designed to collect the fluid. The capillary channel includes a reagent that reacts with the fluid to produce a measurable reaction. The reaction will provide a measurable indication of the concentration of the analyte in the fluid. Coupled to the lid is a lance that is moveable to the base and is moveable to a position adjacent the opening of the capillary channel.

Claims

1. A fluid collection apparatus to test a concentration of an analyte in a fluid, comprising:

a lid;

a base having a plane;

a spacer disposed between said lid and said base, said spacer including a capillary channel having an opening for receiving the fluid; and

a lance disposed between said lid and said base, said lance moveable relative to said base and parallel to said plane of said base, said lance having a piercing end that is moveable to a position adjacent said opening of said capillary channel, said lance extending beyond said lid and said base for puncturing.

2. The fluid collection apparatus of claim 1, wherein said lance is coupled to a guide for moving said lance.

3. The fluid collection apparatus of claim 1, wherein said lance is disposed in said capillary channel.

4. The fluid collection apparatus of claim 1, wherein said capillary channel is elongated and said lance is disposed in said elongated capillary channel, such that said lance is moveable along the length of said capillary channel between a first position and a second position.

5. The fluid collection apparatus of claim 1, further comprising an elongated lancing channel having an end adjacent to said opening of said capillary channel, wherein said lance is disposed in said lancing channel.

6. The fluid collection apparatus of claim 1, wherein said capillary channel has a length of approximately 0.020 to approximately 0.040 inches.

7. The fluid collection apparatus of claim 1, wherein said capillary channel includes a detection area for containing a reagent adapted to produce a reaction indicative of the concentration of the analyte in the fluid.

8. The fluid collection apparatus of claim 7, wherein said detection area has an area of approximately 0.7×

10<sup>−

3</sup> to 10×

10<sup>−

3</sup> inches squared.

9. The fluid collection apparatus of claim 1, wherein said capillary channel has a width of approximately 0.006 to approximately 0.012 inches.

10. The fluid collection apparatus of claim 1, wherein said lance has a diameter of approximately 0.005 to approximately 0.011 inches.

11. The fluid collection apparatus of claim 1, further comprising a reagent disposed in said capillary channel and adapted to produce a reaction indicative of the concentration of the analyte in the fluid.

12. The fluid collection apparatus of claim 11, wherein the reagent is adapted to produce a colorimetric reaction.

13. The fluid collection apparatus of claim 12, in combination with a colorimetric test device.

14. The fluid collection apparatus of claim 11, wherein the reagent is adapted to produce an electrochemical reaction.

15. The fluid collection apparatus of claim 14, in combination with an electrochemical test device.

16. The fluid collection apparatus of claim 1, wherein the analyte is glucose.

17. The fluid collection apparatus of claim 16, in combination with a test device adapted to measure the concentration of glucose in blood.

18. The fluid collection apparatus of claim 1, in combination with a test device adapted to measure the absorption of infrared light by the fluid.

19. A fluid collection apparatus adapted to test a concentration of an analyte in a fluid, comprising:

a lid;

a base having a plane;

a spacer disposed between said lid and said base, said spacer including an elongated capillary channel for receiving the fluid; and

a lance disposed in said capillary channel and moveable parallel to said base of said plane and in between a first position and a second position along the length of said capillary channel.

20. The fluid collection apparatus of claim 19 wherein said capillary channel includes a reagent adapted to produce a reaction indicative of the concentration of the analyte in the fluid.

21. A fluid collection apparatus adapted to test a concentration of an analyte in a fluid, comprising:

a lid;

a base;

a spacer disposed between said lid and said base, said spacer including a capillary channel and a lance chamber, said capillary channel having an opening adjacent to an opening of said lance chamber; and

a lance disposed in said lance chamber, said lance being moveable in said lance chamber such that said lance moves parallel to a plane of said base.

22. The fluid collection apparatus of claim 21, wherein said lance channel is unable to collect fluid.

23. The fluid collection apparatus of claim 21, wherein said lance channel includes at least one face, said at least one face of said lance channel is of a hydrophobic material.

24. The fluid collection apparatus of claim 21, wherein said capillary channel is adapted to collect the fluid, said capillary channel including a reagent adapted to produce a reaction indicative of the concentration of the analyte in the fluid.

25. A fluid collection apparatus adapted to test a concentration of an analyte in a fluid, comprising:

a base;

a guide;

a pair of spacers disposed between said base and said guide, said pair of spacers defining a capillary channel having an opening; and

a lance coupled to said guide, such that a movement of said guide causes a movement of said lance parallel to a plane of said base, an end of said lance moveable to a position adjacent to said opening of said capillary channel;

wherein said capillary channel is adapted to collect the fluid, said capillary channel including a reagent adapted to produce a reaction indicative of the concentration of the analyte in the fluid.

26. The fluid collection apparatus of claim 25, wherein said lance is disposed directly above said capillary channel.

27. The fluid collection apparatus of claim 25, wherein said lance is disposed at an acute angle relative to said capillary channel.

28. The fluid collection apparatus of claim 25, wherein said lance is moveable between a first position and a second position.

29. A method for testing a concentration of glucose in a user'"'"'s blood utilizing a fluid collection apparatus having an integrated lance and a capillary channel located in the same plane, the method comprising:

placing an end of the capillary channel against the user'"'"'s skin;

pushing the lance into the skin so as to puncture the skin and draw blood;

pulling the lance out of the skin;

drawing the blood into the capillary channel without moving the fluid collection apparatus; and

measuring the amount of glucose in the blood.

30. The method of claim 29, wherein the lance is disposed in the capillary channel and the step of pulling the lance out of the skin further comprises pulling the lance out of the capillary channel.

31. The method of claim 29, wherein the lance is disposed in the capillary channel and the step of pulling the lance out of the skin further comprises pulling the lance past the end of the capillary channel.

32. The method of claim 31, wherein the step of pulling the lance past the end of the capillary includes pulling the lance past a reagent in the capillary channel.

33. The method of claim 29, wherein the capillary channel includes a detection area adapted to store a reagent adapted to react with the blood.

34. The method of claim 29, further comprising reacting the blood with a reagent in the capillary channel.

35. The method of claim 34, wherein the step of reacting the blood with the reagent creates a colorimetric reaction.

36. The method of claim 34, wherein the step of reacting the blood with the reagent creates an electrochemical reaction.