Test device for analyzing blood glucose or other analytes in bodily fluids

• US 7,138,089 B2
• Filed: 07/19/2001
• Issued: 11/21/2006
• Est. Priority Date: 07/20/2000
• Status: Expired due to Term

• Current Assignee: ARKRAY, Inc
• Original Assignee: Hypoguard USA Inc. (ARKRAY, Inc)
• Inventors: Woodhead, Andrew James, Black, Murdo M., May, Stuart Richard, Aitken, James
• Primary Examiner(s): Gakh, Yelena G.
• Application Number:
  US09/909,427
• Publication Number:
  US 20020076349A1
• Time in Patent Office: 1,951 Days
• Field of Search: 422/58, 422/61, 422/63, 422/64, 422/66, 422/100, 422/102, 422/104, 436 44- 46, 436/808
• US Class Current: 422/82.01
• CPC Class Codes: G01N 33/48757 Test elements dispensed from a stack
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A test device for testing of analyte concentration in a fluid to be applied thereto, the device comprising a plurality of test members arranged in at least one stack and electrodes for engaging with electrode tracks on a test member. A pusher pushes a single test member from the stack so that it can engage with the electrodes. An actuation member is connected to the pusher, and moves it when operated by a user. The at least one stack of test members is enclosed in a magazine which is initially sealed by a moisture impermeable seal. A cutter is provided for slitting the seal and permitting a test member to be pushed from the magazine by the pusher when the first test member from the magazine is to be used.

Claims

1. A test device for testing of analyte concentration in a fluid to be applied thereto, the device comprising:

a) a plurality of test members arranged in at least a first stack, each of said test members carrying reagent, each of said test members having a plurality of electrode tracks that are adapted and configured to conduct an electrical signal;

b) a housing having electrodes disposed therein that are adapted and configured to engage the electrode tracks of each of the test members of the first stack when such test member is positioned at an engagement location;

c) a meter operatively connected to the electrodes of the housing and disposed at least partly in the housing;

d) a pusher which is adapted to pushably move each of the test members in turn at least partially from the first stack and into the engagement location where such test member will engage with the electrodes of the housing and where such test member can be accessed to apply a fluid to the reagent of such test member;

e) an actuation member operably connected to the pusher, the actuation member being operable by a user to move the pusher relative to the housing;

f) the first stack being contained in a magazine which is initially sealed by a moisture impermeable seal; and

g) a blade, the magazine being movable relative to the housing from an initial position where the seal is intact to a position where the pusher can push a first one of the test members from the first stack, the movement causing the blade to cut the seal in a manner forming a slit through which the first test member is able to pass through as first test member is pushed by the pusher toward the engagement location.

2. A device as claimed in claim 1, further comprising second and third stacks, each of the second and third stacks comprising a plurality of test members, each of said test members carrying reagent and having a plurality of electrode tracks that are adapted and configured to transmit an electrical signal, each of the second and third stacks being contained in a magazine which is initially sealed by a moisture impermeable seal, each of the magazines being movable relative to the housing in a manner such that movement of said magazine causes the blade to slit the seal of said magazine as said magazine is moved to a position where the pusher can push one of the test members of said magazine toward the engagement position.

3. A device as claimed in claim 1, wherein the actuation member is configured and adapted in a manner such that operation of the actuation member causes the pusher to engage with the electrodes of the housing and bring the electrodes of the housing into contact with the electrode tracks on each of the test members when such test member is in the engagement location.

4. A device as claimed in claim 3, wherein the actuation member is configured and adapted in a manner such that further operation of the actuation member causes the pusher to push such test member from the engagement location and eject such test member from the housing.

5. A device as claimed in claim 1, wherein the pusher comprises at least one cutting surface that is adapted and configured to cut the seal.

6. A device as claimed in claim 2, further comprising a cartridge that houses each of the magazines and that is moveable relative to the housing.

7. A device as claimed in claim 6, wherein the device further comprises a ratchet wheel having a keyway, and wherein the cartridge is biased against the ratchet wheel and comprises a plurality of spaced apart location pegs configured and adapted to locate in the keyway, and the ratchet wheel is configured and adapted to permit any one of the location pegs to locate in the keyway only when the ratchet wheel is in a orientation relative to the cartridge.

8. A device as claimed in claim 7, wherein the actuating member is configured and adapted to cause the ratchet wheel to rotate in a manner indexing the keyway of the ratchet wheel with one of the location pegs of the cartridge.

9. A device as claimed in claim 1, further comprising a sliding member having an angled slot therein, the angled slot having a cam surface that bears against the pusher, the sliding member being configured and adapted in a manner such that movement of the sliding member in a first direction causes movement of the pusher in a second direction.

10. A device as claimed in claim 1, further comprising a biasing member that biases the stack of test members towards the seal.

11. A device as claimed in claim 1, wherein the pusher is adapted and configured to be releasable detained in position relative to the housing one of the test members is in the engagement location.

12. A device as claimed in claim 1, further comprising a timer and a display, the timer being configured and adapted to track the duration of time that passes from the breaking of the seal of the magazine by the blade, the display being operatively connected to the timer and being configured and adapted to visibly display indicia indicative of expiration of the useful life of the test members as a result of time that passes from the breaking of the seal of the magazine by the blade.

13. A device as claimed in claim 1, wherein the reagent is adapted and configured to react with blood glucose.

14. A device as claimed in claim 2, wherein the magazines are releasably connected together and wherein the housing has an opening through which each of the magazines can pass through after being separated from the other of the magazines.

15. A device as claimed in claim 1, wherein each test member in the first stack consists of a working portion that is defined by the reagent and a non-working portion, the working portion has a maximum thickness, and the non-working portion has a maximum thickness that is at least as great as the maximum thickness of the working portion.

16. A device as claimed in claim 15, wherein the maximum thickness of the non-working portion is greater than the maximum thickness of the working portion.