Diagnostic strip coding system and related methods of use
First Claim
Patent Images
1. A diagnostic test strip comprising:
- an electrically insulating base layer;
a conductive pattern formed on the base layer providing at least one electrode disposed on the base layer at a proximal region of the strip, electrical strip contacts disposed on the base layer at a distal region of the strip, conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts, and a distinct distal conductive region provided distal to the electrical strip contacts;
a reagent layer contacting at least a portion of at least one electrode; and
an electrically insulating material including a pattern of apertures, the electrically insulating material being disposed over at least a portion of the distal conductive region such that the apertures expose a pattern of the underlying distal conductive region to at least partially form a distinct pattern readable to identify data particular to the test strip.
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Accused Products
Abstract
An auto-calibration system for diagnostic test strips is described for presenting data individually carried on each test strip readable by a diagnostic meter. The carried data may include an embedded code relating to data particular to that individual strip. The data is presented so at to be read by a meter associated with the diagnostic test strip in order to avoid manually inputting the information.
160 Citations
33 Claims
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1. A diagnostic test strip comprising:
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an electrically insulating base layer;
a conductive pattern formed on the base layer providing at least one electrode disposed on the base layer at a proximal region of the strip, electrical strip contacts disposed on the base layer at a distal region of the strip, conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts, and a distinct distal conductive region provided distal to the electrical strip contacts;
a reagent layer contacting at least a portion of at least one electrode; and
an electrically insulating material including a pattern of apertures, the electrically insulating material being disposed over at least a portion of the distal conductive region such that the apertures expose a pattern of the underlying distal conductive region to at least partially form a distinct pattern readable to identify data particular to the test strip. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A method of making a test strip, said method comprising:
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providing a sample chamber;
providing an electrically insulating base layer; and
providing a conductive pattern formed on the base layer including a plurality of electrodes, a plurality of electrical strip contacts, conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts, and a distinct distal conductive region provided distal to the electrical strip contacts;
providing an electrically insulating material including a pattern of apertures; and
disposing the electrically insulating material over at least a portion of the distal conductive region such that the apertures expose a pattern of the underlying distal conductive region to at least partially form a distinct pattern readable to identify data particular to the test strip. - View Dependent Claims (11, 12, 13, 14)
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15. A method of making a plurality of test strips, said method comprising:
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forming a plurality of test strip structures on one sheet, each of said test strip structures including;
a sample chamber;
an electrically insulating base layer; and
a conductive pattern formed on said sheet including a plurality of electrodes, a plurality of electrical strip contacts, conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts, and a distinct distal conductive region provided distal to the electrical strip contacts;
providing an electrically insulating material including a pattern of apertures, disposing the electrically insulating material at least over a portion of the distal conductive region each strip such that the apertures expose a pattern of the underlying distal conductive region on each strip; and
separating said test strip structures into said plurality of test strips. - View Dependent Claims (16, 17, 18, 19, 20)
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21. A method of determining a constituent level within a fluid comprising:
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providing a diagnostic test device comprising;
at least one electrically insulating base layer;
a conductive pattern formed on the at least one base layer including at least one electrode disposed at a proximal region of the strip, electrical strip contacts disposed at a distal region of the strip, conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts and a distinct distal conductive region provided distal to the electrical strip contacts;
a reagent layer contacting at least a portion of at least one electrode; and
an electrically insulating material including a pattern of apertures, the electrically insulating material being disposed over at least a portion of the distal conductive region such that the apertures expose a pattern of the underlying distal conductive region;
connecting the distal region of the strip to a constituent level meter such that the electrical strip contacts and the exposed portions of the distal conductive region engage with corresponding meter connector contacts;
applying a fluid sample at the reagent layer;
taking a measurement using the plurality of electrodes;
identifying particular data based on the pattern formed at least in part by the exposed pattern of the distal conductive region; and
calculating the fluid constituent concentration based on the value of measured current and the data. - View Dependent Claims (22, 23, 24)
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25. A method of determining a constituent level within a fluid comprising:
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providing a diagnostic test device comprising;
at least one strip including an electrically insulating base layer;
a conductive pattern formed on the at least one base layer including at least one electrode disposed at a proximal region of the strip, electrical strip contacts disposed at a distal region of the strip, and conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts;
a reagent layer contacting at least a portion of at least one electrode; and
a pattern of apertures formed through the base layer and the conductive pattern;
connecting the distal region of the strip to a constituent level meter having a light source and a light detector, such that the electrical strip contacts engage with corresponding meter connector contacts;
applying a fluid sample at the reagent layer;
taking a measurement using the plurality of electrodes;
identifying particular data based on the pattern of apertures by emitting light through the pattern of apertures on one side of the strip and detecting light passing through the pattern of apertures with the light detector on an opposite side of the strip; and
calculating the fluid constituent concentration based on the value of measured current and the data.
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26. A diagnostic test strip comprising:
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an electrically insulating base;
a conductive pattern formed on the base providing at least one electrode disposed on the base at a proximal region of the strip, electrical strip contacts disposed on the base at a distal region of the strip, conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts, and a distinct distal conductive region provided separate from the electrical strip contacts;
a reagent layer contacting at least a portion of at least one electrode; and
wherein the distal conductive region presents a distinct conductive pattern readable to identify data particular to the test strip. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33)
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Specification