Integrated meter for analyzing biological samples

• US 8,815,175 B2
• Filed: 06/19/2009
• Issued: 08/26/2014
• 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: Bryer, Philip, Lee, Irving, Berken, Lloyd M., Giraud, Jean-Pierre, Schoenberg, Stephen J.
• Primary Examiner(s): KWAK, DEAN P
• Application Number:
  US12/488,181
• Publication Number:
  US 20090270765A1
• Time in Patent Office: 1,894 Days
• Field of Search: 422/50, 422/68.1, 436/95, 436/128, 600/300, 600/583
• US Class Current: 422/410
• 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 5/150664 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 that are rotatable about 180°

from a first position to a second position 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 at a first rate for lancing the lancing site, retracting the analyte testing structure, reorienting the analyte testing structure, and advancing the analyte testing structure through the port at a second rate for testing at the lancing site, the second rate slower than the first rate;

wherein the set of components comprises a gear coupled to a cam, the gear and cam having a first configuration wherein the cam is movable in concert with the gear through a first biasing element, wherein the movement of the cam in concert with the gear stores potential energy in the first biasing element;

the gear and cam having a second configuration wherein the cam is independently movable with respect to the gear through a release of the potential energy stored in the first biasing element, wherein the independent movement of the cam provides the advancing of the analyte testing structure through the port at the first rate for lancing;

the gear and cam having a third configuration wherein the cam is in a neutral position relative to the analyte testing structure, wherein the analyte testing structure is advanced through the port at the second rate for testing by a second biasing element, and

wherein the set of components comprises a carriage including a turret, wherein the analyte testing structure is disposed in the turret during the advancing for lancing the lancing site, the reorienting, and the advancing for testing the lancing site;

wherein the turret rotates for reorienting the analyte testing structure;

wherein the cam is coupled to the carriage to advance the carriage at the first rate; and

wherein the second biasing element is coupled to the carriage to advance the carriage at the second rate.

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 7, wherein the turret is movable relative to the housing in a same direction for both the lancing and the testing.

9. 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.

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

11. The apparatus of claim 1, wherein the first biasing element is a torsion spring or a clock spring, the torsion spring or the clock spring advancing the analyte testing structure through the port at the first rate for lancing the lancing site.

12. The apparatus of claim 1, wherein the second biasing element is a coil spring, the coil spring advancing the analyte testing structure through the port at the second rate for testing at the lancing site.

13. The apparatus of claim 12, wherein the coil spring is biased to have an amount of potential energy to provide a force of about 2 ounces.

14. The apparatus of claim 12, wherein a biasing of the coil spring requires force from the cam to be removed in order to advance the analyte testing structure through the port at the second rate for testing at the lancing site.

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

16. 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.

17. The apparatus of claim 16, 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.

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

19. The apparatus of claim 18, 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.

20. The apparatus of claim 19, wherein the oscillation is about a point of unstable equilibrium.

21. 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.

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