Diagnostic strip coding system and related methods of use
First Claim
Patent Images
1. A diagnostic test strip, comprising:
- at least one electrically insulating layer;
a conductive pattern formed on the at least one electrically insulating layer including at least one electrode disposed on the at least electrically one insulating layer at a proximal region of the strip, electrical strip contacts disposed on the at least one electrically insulating layer at a distal region of the strip, and conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts and a set of individually electrically isolated contacting pads provided distal to the electrical strip contacts,wherein at least one of the contacting pads is a grounding contacting pad configured to establish a common connection to an electrical ground, the grounding contacting pad including a proximal grounding portion and a distal notch portion electrically separated from the grounding portion, wherein a distal edge of the grounding portion of the grounding pad is positioned on the strip proximally relative to distal edges of the remaining contacting pads;
a reagent layer contacting at least a portion of at least one electrode; and
a machine-readable pattern readable to identify data particular to the strip, the machine-readable pattern formed by the contacting pads and at least one discrete portion of electrical insulating material disposed over an entire surface of at least one of the contacting pads.
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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.
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Citations
34 Claims
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1. A diagnostic test strip, comprising:
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at least one electrically insulating layer; a conductive pattern formed on the at least one electrically insulating layer including at least one electrode disposed on the at least electrically one insulating layer at a proximal region of the strip, electrical strip contacts disposed on the at least one electrically insulating layer at a distal region of the strip, and conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts and a set of individually electrically isolated contacting pads provided distal to the electrical strip contacts, wherein at least one of the contacting pads is a grounding contacting pad configured to establish a common connection to an electrical ground, the grounding contacting pad including a proximal grounding portion and a distal notch portion electrically separated from the grounding portion, wherein a distal edge of the grounding portion of the grounding pad is positioned on the strip proximally relative to distal edges of the remaining contacting pads; a reagent layer contacting at least a portion of at least one electrode; and a machine-readable pattern readable to identify data particular to the strip, the machine-readable pattern formed by the contacting pads and at least one discrete portion of electrical insulating material disposed over an entire surface of at least one of the contacting pads. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. 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 layer; a conductive pattern formed on the at least one insulating layer including at least one electrode disposed on the at least one insulating layer at a proximal region of the strip, electrical strip contacts disposed on at least one insulating layer at a distal region of the strip, and conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts and a set of individually electrically isolated contacting pads provided distal to the electrical strip contacts, wherein at least one of the contacting pads is a grounding contacting pad configured to establish a common connection to an electrical ground, the grounding contacting pad including a proximal grounding portion and a distal notch portion electrically separated from the grounding portion, wherein a distal edge of the grounding portion of the grounding pad is positioned on the strip proximally relative to distal edges of the remaining contacting pads; a reagent layer contacting at least a portion of at least one electrode; and at least one discrete portion of electrical insulating material disposed over an entire surface of at least one of the contacting pads to form a distinct pattern readable to identify data particular to the test strip; connecting the distal region of the strip to a constituent level meter 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 distinct pattern formed at least in part by the electrical insulating material disposed over the entire surface of at least one of the electrical strip contacts; and calculating the fluid constituent concentration based on the value of measured current and the data. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A method of making a plurality of test strips, the method comprising:
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forming a plurality of test strip structures on one sheet, each of the test strip structures including; (a) a sample chamber; (b) an electrically insulating layer; (c) a conductive pattern including a plurality of electrodes formed on the sheet, and a plurality of electrical strip contacts, formed on the sheet, a portion of which are electrically connected to the plurality of electrodes; (d) a set of electrical strip contacts individually electrically isolated to form a discrete set of contacting pads formed on the sheet and electrically isolated from the plurality of electrodes, wherein at least one of the contacting pads is a grounding contacting pad configured to establish a common connection to an electrical ground, the grounding contacting pad including a proximal grounding portion and a distal notch portion electrically separated from the grounding portion, wherein a distal edge of the grounding portion of the grounding pad is positioned on the strip proximally relative to distal edges of the remaining contacting pads; and (e) at least one discrete portion of electrical insulating material disposed over at least an entire surface of one of the contacting pads to at least partially form a distinct pattern readable to identify data particular to the test strip; and separating the test strip structures into the plurality of test strips. - View Dependent Claims (24)
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25. A diagnostic test strip, comprising:
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at least one electrically insulating layer; a conductive pattern formed on the at least one electrically insulating layer including a plurality of electrodes disposed on the at least one electrically insulating layer at a proximal region of the strip, electrical strip contacts disposed on the at least one electrically insulating layer at a distal region of the strip, conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts; a first plurality of electrical strip contacts comprised of contacts individually connected to each of the electrodes; a code pattern comprising a second plurality of electrical strip contacts comprised of the conductive pattern at the distal region of the strip, the second plurality of electrical strip contacts electrically insulated from the electrodes, wherein at least one of the second plurality of electrical strip contacts is a grounding contacting pad configured to establish a common connection to an electrical ground, the grounding contacting pad including a proximal grounding portion and a distal notch portion electrically separated from the grounding portion, wherein a distal edge of the grounding portion of the grounding pad is positioned on the strip proximally relative to distal edges of the remaining electrical strip contacts of the second plurality; and at least one discrete portion of electrical insulating material disposed over an entire surface of at least one of the electrical strip contacts to at least partially form a distinct pattern readable to identify data particular to the strip. - View Dependent Claims (26, 27, 28, 29, 30, 31, 34)
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32. A method of making a test strip comprising:
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providing at least one electrically insulating layer; providing a conductive pattern on the at least one insulating layer, the conductive pattern including at least one electrode disposed on the at least one insulating layer at a proximal region of the strip, electrical strip contacts disposed on at least one insulating layer at a distal region of the strip, and conductive traces electrically connecting the electrodes to at least some of the electrical strip contacts and a set of individually electrically isolated contacting pads provided distal to the electrical strip contacts, wherein at least one of the contacting pads is a grounding contacting pad configured to establish a common connection to an electrical ground, the grounding contacting pad including a proximal grounding portion and a distal notch portion electrically separated from the grounding portion, wherein a distal edge of the grounding portion of the grounding pad is positioned on the strip proximally relative to distal edges of the remaining contacting pads; providing a reagent layer contacting at least a portion of at least one electrode; and selectively covering an entire surface of at least one of the electrical strip contacts with a discrete portion of electrical insulating material to at least partially form a distinct pattern readable to identify data particular to the test strip. - View Dependent Claims (33)
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Specification