Integrated meter for analyzing biological samples

• US 8,435,447 B2
• Filed: 07/26/2010
• Issued: 05/07/2013
• Est. Priority Date: 11/30/2005
• Status: Expired due to Fees

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bryer, Philip, Lee, Irving, Schoenberg, Stephen J., Berken, Lloyd M., Giraud, Jean-Pierre
• Primary Examiner(s): KWAK, DEAN P
• Application Number:
  US12/843,627
• Publication Number:
  US 20100286563A1
• Time in Patent Office: 1,016 Days
• Field of Search: 422/50, 422/68.1, 436/95, 436/128, 600/583, 600/300
• US Class Current: 422/50
• 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 meter, comprising:

a housing, the housing including an outer wall, the outer wall having an interior surface and an exterior surface;

a cartridge containing a plurality of analyte testing structures, the cartridge held within an interior space within the housing; and

a set of mechanical components including;

a pusher that advances an analyte testing structure from the cartridge;

a slot that holds the analyte testing structure when the analyte testing structure is advanced into a first end of the slot by the pusher; and

an electrical connector that electrically couples the analyte testing structure to the meter when the analyte testing structure is held in the slot, the electrical connector enabling a measurement of an analyte level for a fluid sample in contact with the analyte testing structure held in the slot;

wherein the slot permits the removal of the analyte testing structure out a second end of the slot for disposal from the meter after a measurement is performed; and

a curved inner wall surface within the housing, wherein the pusher is adjacent the curved inner wall surface and contacting the curved inner wall surface such that the pusher is curved along the curved inner wall surface, and wherein the pusher is disposed between the curved inner wall surface and the interior surface of the outer wall when advancing the analyte testing structure.

2. The analyte test meter of claim 1, wherein the pusher comprises a flexible piece of material.

3. The analyte test meter of claim 1, wherein the pusher comprises a chain and an end piece for contacting the analyte testing structure.

4. The analyte test meter of claim 1, wherein the pusher extends along a dimension of the housing and bends around one or more corners of the housing when advancing the analyte testing structure.

5. The analyte test meter of claim 1, wherein the pusher winds and unwinds from a coil.

6. The analyte test meter of claim 1, wherein the pusher moves along a curved track within the housing.

7. The analyte test meter of claim 1, wherein the cartridge comprises at least one guide rail for relative positioning within the housing with respect to the set of components.

8. The analyte test meter of claim 1, further comprising:

a seal which generally maintains the plurality of analyte testing structures within the cartridge free from exposure to ambient air, and wherein the analyte test meter is configured to release the seal temporarily to permit advancement of the analyte testing structure to the slot.

9. The analyte test meter of claim 8, wherein the seal is between the cartridge and a tub, and wherein the releasing of the seal comprises moving the tub away from the cartridge.

10. The analyte test meter of claim 1, further comprising:

a biasing member at a loading end of the cartridge for biasing the plurality of analyte testing structures toward a dispensing end of the cartridge.

11. The analyte test meter of claim 1, further comprising:

a mechanical component that advances a lancet to contact a lancing site.

12. The analyte test meter of claim 1, wherein the analyte level comprises a level of glucose or ketone bodies.

13. The analyte test meter of claim 1, wherein the set of components further includes at least one motor for driving one or more components within the analyte testing meter.

14. A set of mechanical components for use in an analyte testing meter, the set of mechanical components comprising:

a housing, the housing including an outer wall, the outer wall having an interior surface and an exterior surface;

a pusher that advances an analyte testing structure from a cartridge stored within the housing of an analyte testing meter, the cartridge containing a plurality of analyte testing structures;

a curved inner wall surface within the housing, wherein the pusher is adjacent the curved inner wall surface and contacting the curved inner wall surface such that the pusher is curved along the curved inner wall surface, and wherein the pusher is disposed between the curved inner wall surface and the interior surface of the outer wall when advancing the analyte testing structure;

a slot that holds the analyte testing structure when the analyte testing structure is advanced into a first end of the slot by the pusher; and

an electrical connector that electrically couples the analyte testing structure to the meter when the analyte testing structure is held in the slot, the electrical connector enabling a measurement of an analyte level for a fluid sample in contact with the analyte testing structure held in the slot;

wherein the slot permits the removal of the analyte testing structure out a second end of the slot for disposal from the meter after a measurement is performed.

15. The set of mechanical components of claim 14, wherein the pusher comprises a flexible piece of material.

16. The set of mechanical components of claim 14, wherein the pusher comprises a chain and an end piece for contacting the analyte testing structure.

17. The set of mechanical components of claim 14, wherein the pusher extends along a dimension of the housing and bends around one or more corners of the housing when advancing the analyte testing structure.

18. The set of mechanical components of claim 14, wherein the pusher winds and unwinds from a coil.

19. The set of mechanical components of claim 14, further comprising:

a curved track within the housing, wherein the pusher moves along the curved track.

20. The set of mechanical components of claim 14, wherein the cartridge comprises at least one guide rail for relative positioning within the housing with respect to the set of components.

21. The set of mechanical components of claim 14, further comprising:

a seal which generally maintains the plurality of analyte testing structures within the cartridge free from exposure to ambient air, and wherein the analyte test meter is configured to release the seal temporarily to permit advancement of the analyte testing structure to the slot.

22. The set of mechanical components of claim 14, wherein the seal is between the cartridge and a tub, and wherein the releasing of the seal comprises moving the tub away from the cartridge.

23. The set of mechanical components of claim 14, further comprising:

a biasing member at a loading end of the cartridge for biasing the plurality of analyte testing structures toward a dispensing end of the cartridge.

24. The set of mechanical components of claim 14, further comprising:

a mechanical component that advances a lancet to contact a lancing site.

25. The set of mechanical components of claim 14, wherein the analyte level comprises a level of glucose or ketone bodies.

26. The set of mechanical components of claim 14, further comprising:

at least one motor for driving one or more components within the analyte testing meter.