Gating system and method for biosensor test strips

Inventors

Davies, StephenModzelewski, Brent E.Akins, Jeffrey

Assignees

Trividia Health Inc

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Publication Number

US-10309920-B2

Patent

Publication Date

2019-06-04

Expiration Date


Abstract

A system is disclosed, the system comprises a diagnostic test strip having a diagnostic end and a meter contacting end, the meter contacting end having at least one identifying feature that distinguishes the meter contacting end from the diagnostic end; a diagnostic meter configured to read information from the meter contacting end of the test strip when the meter contacting end of the test strip is fully inserted in to the meter; and a port in the meter, the port having a gating mechanism configured to identify the meter contacting end and allow the test strip to be fully inserted into the meter only after the gating mechanism identifies the meter contacting end of the test strip as a proper end for insertion.

Core Innovation

An electrochemical biosensor system includes a diagnostic test strip with a diagnostic end and a meter contacting end. The meter contacting end has at least one identifying feature that distinguishes the meter contacting end from the diagnostic end. A diagnostic meter is configured to read information from the meter contacting end of the test strip when the meter contacting end is fully inserted into the meter.

A port in the meter includes a gating mechanism that identifies the meter contacting end and allows the test strip to be fully inserted only after the gating mechanism identifies the meter contacting end as a proper end for insertion. The gating mechanism includes one or more gates configured to be closed to prevent insertion of the test strip until the gating mechanism recognizes the strip, thereby reducing incorrect insertion and bodily fluids ingress to meter internals.

The gating mechanism is implemented with structured identification and unlocking, using identifying features such as one or more of width, thickness, or a predetermined shaping of the meter contacting end. The gating mechanism can include multiple gate components, including gate components with stops and risers, inclined planes opened in a predetermined sequence, and mechanical and electromechanical analogs such as toothed gears, a rack-and-pinion type action, a rocker-switch lever, and a sled-type gating concept.

Claims Coverage

The document provides three independent claims: a system claim, a meter claim, and a method claim. Across these claims, the coverage centers on an insertion-gating recognition mechanism tied to an identifying feature on the meter contacting end, where one or more gates are closed until the correct end is identified for full insertion; the meter then reads information from the test strip.

Gate-controlled full insertion based on proper end identification

A port in the meter having a gating mechanism configured to identify the meter contacting end and allow the test strip to be fully inserted only after the gating mechanism identifies the meter contacting end as a proper end for insertion, wherein the gating mechanism includes one or more gates configured to be closed to prevent insertion of the test strip until the gating mechanism recognizes the strip.

Identifying feature on the meter contacting end

The meter contacting end having at least one identifying feature that distinguishes the meter contacting end from the diagnostic end.

Meter reading after full insertion

A diagnostic meter configured to read information from the meter contacting end of the test strip when the meter contacting end of the test strip is fully inserted into the meter.

Multiple gate components for recognition

A gating mechanism including one or more gates configured to be closed to prevent insertion of the test strip until the gating mechanism recognizes the strip, wherein the gating mechanism includes multiple gate components that identify the meter contacting end of a diagnostic test strip.

Ordered gate opening via pre-set contact sequence

A gating mechanism configured to allow the test strip to be fully inserted into a port only after multiple gate components contact a meter contacting end in a specific, pre-set order.

Inclined planes opened by predetermined sequence contact

A gating mechanism with one or more inclined planes where a test strip is shaped and sized to contact each inclined plane in a predetermined order to open the gating mechanism.

Stop-and-riser gate lifting/opening structure

A gating mechanism with two or more gates, each of the gates having at least one stop and at least one riser, the stop contacting the meter contacting end to lift the riser and open the gating mechanism.

Fluid sample placement, gated insertion, and reading

Placing a sample of a fluid for analysis on a diagnostic test strip; inserting the meter contacting end into a port of the meter having a gating mechanism that identifies the meter contacting end and allows the test strip to be fully inserted into the meter only after the gating mechanism identifies the meter contacting end, wherein the gating mechanism includes one or more gates configured to be closed to prevent insertion until the gating mechanism recognizes the strip; and causing the meter to read the information on the diagnostic test strip.

Across the independent claims, the document covers a diagnostic test strip and meter in which full insertion is permitted only after a port gating mechanism identifies the correct meter contacting end, using identifying features and gate-opening interactions including multiple gate components, predetermined contact order, inclined planes, and stops and risers. After authorized full insertion, the meter reads the information on the diagnostic test strip.

Stated Advantages

Reduces incorrect insertion into the meter.

Reduces bodily fluids ingress to meter internals/avoids contamination of meter internals.

Documented Applications

Electrochemical sensing in a diagnostic context using a diagnostic test strip and diagnostic meter, where gating prevents incorrect insertion and bodily fluids ingress.

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