Test strip holding and reading mechanism for a meter

• US 5,232,668 A
• Filed: 02/27/1991
• Issued: 08/03/1993
• Est. Priority Date: 02/27/1991
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Boehringer Mannheim Corporation
• Inventors: Storvick, David E., Gregory, Mark A., Grant, Michael E., Scopatz, Stephen D., Riedel, Richard, Kennedy, Daniel L., Perin, Dino, Gray, Russell T.
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): Soderquist, Arlen
• Application Number:
  US07/661,850
• Time in Patent Office: 888 Days
• Field of Search: 427/58, 427/68.1, 427/82.05, 436/164, 436/165, 128/770
• US Class Current: 422/82.05
• CPC Class Codes: G01N 2021/478 Application in testing analytical test strips
• CPC Class Codes: G01N 21/474 Details of optical heads therefor, e.g. using optical fibres
• CPC Class Codes: G01N 21/75 Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated systems in which material is burnt in a flame or plasma G01N21/72, G01N21/73
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04

Abstract

An instrument for analyzing test strips supporting chemistries which react with a medically significant component of a body fluid to indicate the concentration of the component in the body fluid. The instrument includes a pathway along which radiation is guided from a radiation source to a strip when the strip is inserted into the instrument and along which remission is guided from the strip to a radiation detector. A title provided on the instrument provides a first remission when no strip is inserted into the instrument. The tile is separated from the radiation source by the strip when the strip is inserted into the instrument. The first remission and the strip'"'"'s remission, respectively, indicate the absence and the presence of the strip in the instrument. The strip also has a surface opposite the chemistry supporting surface characterized by a second strip remission different from the first strip remission. The instrument is capable of determining whether the strip has been inserted into the instrument correctly or backward.

Claims

1. In combination, a strip supporting a reagent chemistry the remission of which changes as the chemistry reacts with a component of a body fluid to indicate the concentration of the component in the body fluid, the strip having opposed major surfaces, and a device for accepting the strip, the device comprising a pathway along which radiation is guided from a radiation source to the chemistry when the strip is properly inserted into the device and along which remission is guided from the chemistry to a radiation detector when the strip is properly inserted into the device, a tile having a tile surface for providing a standard remission, means for movably supporting the tile to permit the tile surface to move from a position in which the tile surface receives radiation from the radiation source and produces the standard remission which is guided along the pathway to the radiation detector when no strip is inserted into the device to a position separated from the radiation source by the strip when the strip is inserted into the device, the means for movably supporting the tile comprising a strip carrier body having a surface facing the tile, a lift for movable engagement by the strip carrier body, one of the strip carrier body and lift providing a pair of elongated slots the long dimensions of which extend generally transversely to the directions of motion of the strip into and from the device and generally transversely to the major surfaces of the strip when the strip is inserted into the device, the other of the strip carrier body and lift having a pair of oppositely extending trunnions for engaging the slots, the lift further including incline means for engagement by the strip as the strip is inserted into the device to move the lift away from the strip carrier body as permitted by the engagement of the trunnions in the slots and permit insertion of the strip between the strip carrier body and lift, the incline means provided at an entry end of the strip carrier body and lift, means for yieldably urging the lift toward the facing surface of the strip carrier body so that the lift lies against the facing surface of the strip carrier body when no strip is inserted into the device.

2. The combination of claim 1 wherein one of the lift and tile further includes a pair of opposed, aligned holes extending generally transversely to the directions of motion of the strip into and from the device, the axes of the holes extending generally parallel to the major surfaces of the strip when the strip is inserted into the device, the other of the lift and tile including a pair of oppositely extending second trunnions for engaging the holes to mount the tile pivotally from the lift.

3. The combination of claim 1 wherein the tile and the strip carrier body surface facing the tile are so shaped that the tile surface is spaced from the facing surface of the strip carrier body when no strip is inserted into the device and spaced from the strip when a strip is inserted into the device.

4. The combination of claim 1 and further comprising a housing for positioning the assembly including the strip carrier body, the lift and the tile, the housing including a second surface remote from, and generally parallel to, the strip carrier body surface facing the tile when the assembly including the strip carrier body, the lift and the tile is positioned in the housing, the lift and tile lying between the strip carrier body surface facing the tile and the second surface, the means for yieldably urging the lift toward the strip carrier body surface facing the tile comprises a compression spring, and the compression spring bears against the second surface and at least one of the lift and the tile.

5. The combination of claim 4 wherein the housing includes a third surface lying adjacent, and extending generally parallel to, the strip carrier body, one of the third surface and strip carrier body being provided with a locating protrusion and the other of the third surface and strip carrier body being provided with a recess for receiving the protrusion to locate the strip carrier body, lift and tile correctly within the housing when the assembled strip carrier body, lift and tile are slidably inserted into the housing.

6. The combination of claim 5 wherein the protrusion and the relief are generally frustoconical.

7. The combination of claim 6 wherein the protrusion is provided on the third surface.

8. The combination of claim 1 further including a housing for positioning the assembly including the strip carrier body, the lift and the tile, wherein the housing further comprises means for supporting the radiation source, the pathway along which radiation is guided from the source to the chemistry when the strip is properly inserted into the device including a first slot formed in the strip carrier body surface facing the tile opposite the tile when no strip is inserted into the device and opposite the chemistry when a strip is properly inserted into the device, the first slot being located adjacent the means for supporting the radiation source for directing radiation from the radiation source onto the tile when no strip is inserted into the device and for directing radiation from the radiation source onto the chemistry when a strip is properly inserted into the device.

9. The combination of claim 8 wherein the housing further includes a second surface which lies adjacent the strip carrier body surface facing the tile when the assembly including the strip carrier body, lift and tile is inserted into the housing, the second surface lying adjacent the strip carrier body and extending generally parallel to the strip carrier body surface facing the tile, and a second pathway along which radiation is guided from a second radiation source to the strip when a strip is inserted into the device and along which remission is guided from the strip to a second radiation detector when a strip is inserted into the device.

10. The combination of claim 9 incorporated into an instrument for determining the concentration of the component of a body fluid and for indicating the determined concentration of the component to a user of the instrument, the instrument comprising an instrument case for the instrument'"'"'s components including the device, one of the instrument'"'"'s components comprising a printed circuit board, the housing, the first-mentioned and second radiation sources, and the first-mentioned and second radiation detectors being mounted on the printed circuit board.

11. The combination of claim 1 further including a housing for positioning the assembly including the strip carrier body, the lift and the tile, wherein the housing further comprises means for supporting the radiation source, the pathway along which remission is guided from the chemistry to the radiation detector when a strip is properly inserted into the device including a first slot formed in the strip carrier body surface facing the tile opposite the tile when no strip is inserted into the device and opposite the chemistry when a strip is properly inserted into the device, the first slot being located adjacent the means for supporting the radiation source for directing radiation from the radiation source onto the tile when no strip is inserted into the device and for directing radiation from the radiation source onto the chemistry when a strip is properly inserted into the device.

12. The combination of claim 8 or 11 wherein the housing includes a third surface which lies adjacent the strip carrier body surface facing the tile when the assembly including the strip carrier body, the lift and the tile is inserted into the housing, the third surface lying adjacent the strip carrier body and extending generally parallel to the strip carrier body surface facing the tile, the pathway along which remission is guided from the chemistry to the detector when a strip is properly inserted into the device including a second slot formed in the third surface adjacent the first slot.

13. The combination of claim 12 wherein the housing includes a fourth surface lying at a small, nonzero angle to the third surface, the pathway along which radiation is guided from the source to the chemistry when a strip is properly inserted into the device including a third slot formed in the fourth surface.

14. The combination of claim 13 wherein the fourth surface lies between the means for supporting the radiation source and the chemistry when a strip is properly inserted into the device.

15. The combination of claim 13 wherein the third slot lies between the source and the chemistry when a strip is properly inserted into the device.

16. The combination of claim 15 wherein the first slot lies between the third slot and the chemistry when a strip is properly inserted into the device.

17. The combination of claim 16 wherein the first slot lies between the chemistry and the detector when a strip is properly inserted into the device.

18. The combination of claim 17 wherein the second slot lies between the first slot and the detector.

19. The combination of claim 1 incorporated into an instrument for determining the concentration of the component of a body fluid and for indicating the determined concentration of the component to a user of the instrument, the instrument comprising an instrument case for the instrument'"'"'s components including the lift, the tile and the strip carrier body, the case including a removable case portion having an exterior surface and an interior surface, the exterior surface lying on the outside of the case when the case portion is in its use orientation on the instrument, and the interior surface lying on the inside of the case when the case portion is in its use orientation on the instrument, one of the interior surface and the strip carrier body provided with a pair of generally pawl-shaped members which extend away from the interior surface and define between them a slot which opens into a somewhat triangular region near their ends remote from the interior surface, then closes back to its slot configuration, the other of the interior surface and the strip carrier body including a web portion having opposite sides from each of which project two, generally parallel guide ribs and, between the guide ribs of each pair, a projection for engaging the triangular region defined between the remote ends of the pawl-shaped members when the web portion is inserted into the slot.

20. The combination of claim 1 incorporated into an instrument for determining the concentration of a medically significant component of a body fluid and for indicating the determined concentration of the medically significant component to a user of the instrument.

21. The combination of claim 20 comprising an instrument case for the instrument'"'"'s components including the device, the case defining an instrument exterior, the case including a holder for supporting the strip carrier body, lift and tile assembly and for aligning and orienting the strip carrier body, lift and tile assembly for sliding insertion into, and removal from, the instrument, the strip carrier body including a web region extending longitudinally of the directions of motion of the strip carrier body, lift and tile assembly into and from the instrument, a pawl provided on the web region, the pawl having a locking surface on the side thereof which projects first into the instrument and an inclined camming surface on the side thereof which retracts first out of the instrument, the holder including a pair of resilient fingers between which the web is slidably received when the strip carrier body is in the instrument, one of the fingers including a pawl receiving portion having an inclined face and a locking face, the pawl engaging in the pawl receiving portion with the locking surface of the pawl engaging the locking face of the pawl receiving portion and the inclined surface of the pawl engaging the inclined face of the pawl receiving portion.

22. In combination, a strip supporting a reagent chemistry which reacts with a component of a body fluid to indicate the concentration of the component in the body fluid, and a device for accepting the strip, the device comprising a pathway along which radiation is guided from a radiation source to the strip when the strip is inserted into the device and along which remission is guided from the strip to a radiation detector when the strip is inserted into the device, a housing for providing a first remission, the housing receiving radiation from the radiation source and producing the first remission which is guided along the pathway to the radiation detector when no strip is inserted into the device, the housing separated from the radiation source by the strip when the strip is inserted into the device, the first remission and the strip'"'"'s remission respectively indicating the absence and the presence of the strip in the device, the strip having first and second opposed major surfaces, the strip'"'"'s remission being the remission of said first major surface, said second major surface having a second strip remission different from the first strip remission, the radiation detector producing a first output in response to detection of the first strip remission and a second and different output in response to the second strip remission, the first strip remission and the second strip remission respectively indicating first and second orientations of the strip in the device.

23. The combination of claim 22 wherein the device further comprises a second radiation source, a second radiation detector, and a second pathway along which radiation is guided from the second source to the chemistry when the strip is properly inserted into the device and along which remission is guided from the strip to the second radiation detector when the strip is properly inserted into the device, the second radiation detector producing different outputs based upon differences in remission of the chemistry corresponding to different concentrations of the component in the body fluid.