Integrated meter for analyzing biological samples

• US 7,922,971 B2
• Filed: 09/28/2006
• Issued: 04/12/2011
• Est. Priority Date: 11/30/2005
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Schoenberg, Stephen J., Bryer, Philip, Lee, Irving, Berken, Lloyd M., Giraud, Jean-Pierre
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): KWAK, DEAN P
• Application Number:
  US11/535,985
• Publication Number:
  US 20080167578A1
• Time in Patent Office: 1,657 Days
• Field of Search: 422/50, 422/68.1, 600/583, 600/300, 436/95, 436/128
• US Class Current: 422/50
• 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 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• 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 5/150564 Protectors removed by pulling or pushing
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150793 Electrical or magnetic identification means
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• 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 1/54 : involving glucose or galactose
• CPC Class Codes: G01N 33/48757 : Test elements dispensed from a stack
• CPC Class Codes: G01N 33/54386 : Analytical elements
• CPC Class Codes: Y10T 436/144444 : Glucose
• CPC Class Codes: Y10T 436/200833 : Carbonyl, ether, aldehyde or ketone containing

Abstract

Analyte monitoring devices and methods therefore are provided. The devices integrate various functions of analyte monitoring, e.g., sample acquisition and testing.

Claims

1. An analyte monitoring apparatus, comprising:

a housing;

a user interface coupled with the housing including one or more switches or a display or both;

one or more integrated lancet and test strips contained in the housing that include both a lancet and an analyte test strip at different ends of the integrated lancet and test strip,

wherein a longitudinal axis extends from the lancet end to the analyte test strip end of the integrated lancet and test strip, and wherein the test strip is flat and a lateral axis extends within a plane of the test strip and perpendicular to the longitudinal axis;

a lancing and testing port defined in the housing for permitting the integrated lancet and test strip to contact a lancing site outside the housing;

a set of mechanical components for loading an integrated lancet and test strip for a lancing and testing process, for advancing the integrated lancet and test strip for lancing through said port at a lancing site proximate to the port, for re-orienting the integrated lancet and test strip such that the integrated lancet and test strip is rotated about a line parallel to the lateral axis, and for advancing the integrated lancet and test strip for testing at said lancing site also through said port; and

an analyzer for determining an analyte level of a body fluid applied to the test strip from the lancing site.

2. The apparatus of claim 1, further comprising a cartridge coupled into a slot in the housing which contains several integrated lancet and test strips.

3. The apparatus of claim 2, wherein the cartridge comprises at least one guide rail for relative positioning within the housing with respect to the set of mechanical components.

4. The apparatus of claim 2, further comprising a seal which generally maintains the integrated lancet and test strips within the cartridge free from exposure to ambient air, and is configured for releasing the seal temporarily to permit loading of an integrated lancet and test strip for a lancing and testing process.

5. The apparatus of claim 4, wherein the seal comprises an elastomeric seal.

6. The apparatus of claim 4, wherein the seal comprises a bellows.

7. The apparatus of claim 4, wherein the cartridge comprises at least one guide rail for relative positioning within the housing with respect to the set of mechanical components, said guide rail having a stopping point at which the cartridge remains stationary relative to the housing when said seal is temporarily broken for loading the integrated lancet and test strip.

8. The apparatus of claim 2, wherein the cartridge comprises a biasing member for providing the integrated lancet and test strips at a loading end of the cartridge.

9. The apparatus of claim 2, wherein the cartridge comprises a structural support for the integrated lancet and test strips within the cartridge.

10. The apparatus of claim 9, wherein the cartridge comprises a desiccating member for keeping the integrated lancet and test strips substantially free of moisture.

11. The apparatus of claim 10, wherein one or both of the structural support and desiccating member are provided as inserts.

12. The apparatus of claim 11, wherein the inserts comprise a hard plastic insert for providing said structural support and a desiccating plastic insert for providing said desiccating.

13. The apparatus of claim 1, wherein the set of mechanical components comprises an integrated lancet and test strip slot for holding the integrated lancet and test strip during re-orientation which includes rotation of the integrated lancet and test strip.

14. The apparatus of claim 13, wherein the integrated lancet and test strip slot is coupled with a cam that oscillates between points corresponding to different orientations of the integrated lancet and test strip for lancing and testing.

15. The apparatus of claim 14, wherein the said oscillation is about a point of unstable equilibrium.

16. The apparatus of claim 1, wherein the lancet and analyte test sensor are each coupled to a lancet body.

17. The apparatus of claim 16, wherein the lancet and test sensor each protrude from the lancet body, and wherein the one or more integrated lancet and test strips further comprise a lancet cap protecting the protruding lancet;

and wherein said set of mechanical components include a cover-storing portion for removing the lancet cap.

18. The apparatus of claim 17, wherein the cover-storing portion is for providing a space and a frictional force for holding the lancet cap during a lancing and testing process, and for providing the lancet cap to re-cover the lancet for safe ejection of a used integrated lancet and test strip.

19. The apparatus of claim 1, wherein the set of mechanical components comprises:

(i) a first mechanical subset including a first set of gears, a pusher, a tub sealing with a cartridge including the one or more integrated lancet and test strips, and a turret including an integrated lancet and test strip slot within which the integrated lancet and test strip is disposed during lancing and testing, wherein the first mechanical subset is for unsealing the tub and cartridge for accessing the integrated lancet and test strip, advancing the integrated lancet and test strip to the turret, and ejecting the integrated lancet and test strip after testing; and

(ii) a second mechanical subset including a second set of gears, a blade and mating lancet cap contour, the turret, and a carriage which contains the turret, wherein the second mechanical subset is for arming/disarming the lancet by removing/replacing the lancet cap from/to over the lancet, re-orienting the integrated lancet and test strip between lancing and testing, and performing both lancing and testing through the lancing and testing port at the lancing site.

20. The apparatus of claim 19, wherein the disarming comprises replacing the lancet cap for safe ejection of a used testing integrated lancet and test strip.

21. The apparatus of claim 19, wherein the carriage translates in a same direction for both the lancing and the testing.

22. The apparatus of claim 21, wherein opposite ends of the integrated lancet and test strip are sequentially provided through the same lancing and testing port for the lancing and the testing.

23. The apparatus of claim 1, wherein the re-orienting of the integrated lancet and test strip comprises rotating the integrated lancet and test strip.

24. The apparatus of claim 1, wherein the re-orienting of the integrated lancet and test strip comprises flipping the integrated lancet and test strip.

25. The apparatus of claim 1, further including a transmission system for orienting said lancing/collecting assembly in a first position, whereby a lancet associated with said lancet-containing portion of said test strip can be used to form an opening in the skin of a patient, and in a second position, whereby a sensor associated with said sensor-containing portion of said test strip can be used to collect a sample of biological liquid from said patient.

26. The apparatus of claim 1, wherein the analyte comprises blood glucose.