INTEGRATED METER FOR ANALYZING BIOLOGICAL SAMPLES

• US 20090270765A1
• Filed: 06/19/2009
• Published: 10/29/2009
• Est. Priority Date: 11/30/2005
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Nicholls, Clive, Ghesquiere, Alexander, Cabrall, John J., Matula, Scott A.
• Granted Patent: US 8,815,175 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/14546 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 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• 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 5/15123 comprising magnets or solenoids
• 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 5/15132 comprising tooth-shaped elements, e.g. toothed wheel or rack and pinion
• 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 33/4875 : Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B
• 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 testing apparatus, comprising:

a housing;

one or more analyte testing structures provided in the housing, wherein each structure comprises a lancet and an analyte test sensor;

a port in the housing for the analyte test structure to contact a lancing site on a subject; and

a set of components for;

advancing an analyte testing structure through the port for lancing the lancing site;

reorienting the analyte testing structure, and

advancing the analyte testing structure through the port for testing at the lancing site,

wherein the set of components comprises a mechanism for moving the analyte testing structure when lancing the skin at a rate which is faster than that which is used for moving the analyte testing structure when testing at the lancing site.

2. The apparatus of claim 1, further comprising a cartridge held within an interior space within the housing, the cartridge containing a plurality of analyte testing structures.

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 components.

4. The apparatus of claim 2, further comprising a seal which generally maintains the analyte testing structures within the cartridge free from exposure to ambient air, and wherein the apparatus is configured to release the seal temporarily to permit loading of a single analyte testing structures for lancing and testing.

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

6. The apparatus of claim 2, further comprising a biasing member at a loading end of the cartridge for biasing the analyte testing structures toward a dispensing end of the cartridge.

7. The apparatus of claim 1, wherein the set of components comprises a turret for holding an analyte testing structure during reorientation.

8. The apparatus of claim 1, wherein each of the one or more analyte testing structures further comprises a cap covering the lancing end;

and wherein the set of components includes a mechanism for removing the lancet cap.

9. The apparatus of claim 8, wherein the set of components includes a mechanism for replacing the lancet cap.

10. The apparatus of claim 1, wherein the mechanism for moving the element at a faster rate comprises a clock spring.

11. The apparatus of claim 1, wherein the mechanism for moving the element at a slower rate comprises a coil spring.

12. The apparatus of claim 11, wherein the coil spring applies a force of about 2 ounces.

13. The apparatus of claim 1, wherein the set of components comprises at least one motor for driving certain other components.

14. The apparatus of claim 1, further comprising a plurality of electro-optical encoders associated with the at least one motor for determining the position and speed of the respective components which it drives.

15. The apparatus of claim 14, further comprising a plurality of sensors positioned within the housing along a path traversed by an element, wherein the encoders and sensors function within a closed loop control system.

16. The apparatus of claim 1, wherein the set of mechanical components comprises a slot for holding the analyte testing structure during re-orientation of the analyte testing structure.

17. The apparatus of claim 16, wherein the analyte testing structure slot is coupled with a cam that oscillates between points corresponding to different orientations of the analyte testing structure for lancing and testing.

18. The apparatus of claim 17, wherein the oscillation is about a point of unstable equilibrium.

19. The apparatus of claim 7, wherein the turret moves relative to the housing in a same direction for both the lancing and the testing.

20. The apparatus of any of claims 1, wherein opposite ends of the analyte testing structure are sequentially provided through the port for the lancing and the testing.

21. The apparatus of any of claims 1, wherein the re-orienting of the analyte testing structure comprises rotating the analyte testing structure about 180°

from a first position to a second position.

22. The apparatus of any of claims 1, wherein the analyte comprises glucose or ketone bodies.

23. A method of measuring an analyte level in a sample of bodily fluid using an integrated lancing and testing meter, comprising:

piercing a lancing site on a subject with a lancet portion of an analyte testing structure comprising a lancet and an analyte test sensor;

reorienting the analyte testing structure within the meter;

contacting the analyte test sensor portion of the analyte testing structure at the lancing site, wherein the step of piercing is performed at a faster rate than the step of contacting the lancing site with the test sensor; and

measuring an analyte level in a sample of bodily fluid.

24. The method of claim 23, wherein the steps of loading, piercing, reorienting and contacting are performed automatically by an integrated system.

25. The method of claim 24, further comprising disarming the lancing end and disposing of the element.

26. The method of claim 24, wherein disarming the lancing end comprises removing a cap therefrom.

27. The method of claim 23, wherein the lancet and the analyte test sensor portion are provided on opposite ends of the analyte testing structure.

28. The method of claims 23, wherein the lancet and the analyte test sensor portion of the analyte testing structure and are sequentially advanced through a port of the meter for the lancing and the testing.

29. The method of any of claims 23, wherein the re-orienting of the analyte testing structure comprises rotating the analyte testing structure about 180°

from a first position to a second position.

30. The method of any of claims 23, wherein the analyte comprises blood glucose or ketone bodies.