Analyte concentration determination devices and methods of using the same

• US 20030208140A1
• Filed: 05/01/2002
• Published: 11/06/2003
• Est. Priority Date: 05/01/2002
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Pugh, Jerry T.
• Granted Patent: US 6,945,943 B2
• Time in Patent Office: Days
• US Class Current: 600/584
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150809 by audible feedback
• CPC Class Codes: A61B 5/150824 by visual feedback
• 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

Devices and methods for analyte concentration determination are provided. The subject devices have a housing having an aperture, a lancing element having a lancet held therein disposed within the housing, means for activating the lancing element to displace the lancet to provide an incision in an area of skin to provide physiological sample, and means for determining whether a sufficient amount of the physiological sample is present at the surface of the skin. The subject methods include lancing an area of skin to provide physiological sample at the surface of the area of skin, illuminating the physiological sample present at the surface of skin, detecting light reflected from the physiological sample, and determining whether the physiological sample is present in an amount sufficient for analyte concentration determination based upon the detected light. The subject invention also includes kits for use in practicing the subject methods.

Claims

1. A device for determining the concentration of an analyte in a physiological sample, said device comprising:

(a) a housing having an aperture;

(b) a lancing element having a lancet held therein disposed within said housing;

(c) means for activating said lancing element to displace said lancet through said aperture to provide an incision in an area of skin to provide physiological sample at the surface of said incised area of skin; and

(d) means for determining whether a sufficient amount of said physiological sample is present at the surface of said incised area of skin for analyte concentration determination.

2. The device according to claim 1, further comprising at least one tester stored within said housing.

3. The device according to claim 2, further comprising a tester movement element configured to move said at least one tester in contact with said sufficient amount of sample through said aperture.

4. The device according to claim 3, wherein said tester movement element is actuated automatically.

5. The device according to claim 3, wherein said test strip movement element is actuated manually.

6. The device according to claim 3, wherein said tester movement element is actuated when a sufficient amount of said physiological sample is determined to be present at said area of skin.

7. The device according to claim 1, further comprising a physiological sample promoting element configured to increase the amount of said physiological sample at said surface of said incised area of skin.

8. The device according to claim 1, wherein said device is photometric.

9. The device according to claim 1, further comprising means for determining the concentration of an analyte in said physiological sample.

14. A method for determining the concentration of an analyte in a physiological sample, said method comprising:

(a) providing a device according to claim 1;

(b) operatively positioning said device in relation to an area of skin to be lanced;

(c) activating said lancing element to displace said lancet, whereby said lancet contacts said area of skin and provides an incision in said area of skin to provide physiological sample at the surface of said skin;

(d) illuminating said physiological sample present at said surface of skin;

(e) detecting light reflected from said physiological sample present at said surface of skin; and

(f) determining whether said physiological sample is present at said surface of said skin in an amount sufficient for analyte concentration determination based upon said detected reflected light.

15. A kit for containing at least one test strip and dispensing a single test strip at a time, said kit comprising:

(a) at least one device according to claim 1;

and

(b) a substrate comprising instruction for using said at least one device.

16. The kit according to claim 15, further comprising at least one tester.

17. The kit according to claim 15, further comprising a plurality of testers stored in a cartridge.

18. The kit according to claim 15, further comprising at least one disposable lancet.

19. The kit according to claim 15, further comprising control solution.

10. A method for determining the concentration of an analyte in a physiological sample, said method comprising:

(a) lancing an area of skin to provide an incision in said area of skin, whereby physiological sample is provided at the surface of said area of skin;

(b) illuminating said physiological sample present at said surface of skin;

(c) detecting light reflected from said physiological sample present at said surface of skin; and

(d) determining whether said physiological sample is present at said surface of said skin in an amount sufficient for analyte concentration determination based upon said detected reflected light.

11. The method according to claim 10, further comprising determining the concentration of an analyte in said physiological sample determined to be present in a sufficient amount, whereby analyte concentration is not determined if an insufficient amount of sample is not present.

12. The method according to claim 11, wherein said analyte concentration determination comprises moving a tester in contact with said physiological sample determined to be present in a sufficient amount, whereby a tester is not moved into contact with said physiological sample determined to be present in an insufficient amount.

13. The method according to claim 10, further comprising increasing the amount of physiological fluid expressed from said incised area of skin by applying a force to the perimeter of incised said area, thereby increasing the amount of said physiological fluid at said incised site.