Diagnostic strip coding system and related methods of use
Inventors
Neel, Gary T. • Modzelewski, Brent E. • Caban, Allan Javier • Will, Adam Mark • Oti, Carlos
Assignees
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Publication Number
US-9012232-B2
Publication Date
2015-04-21
Expiration Date
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.
Core Innovation
A diagnostic test strip includes at least one electrically insulating layer and a conductive pattern formed on the insulating layer. The conductive pattern includes at least one electrode disposed on the insulating layer 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 and a set of individually electrically isolated contacting pads distal to the electrical strip contacts.
At least one of the contacting pads is a grounding contacting pad configured to establish a common connection to an electrical ground, including a proximal grounding portion and a distal notch portion electrically separated from the grounding portion. The strip further includes 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 is 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.
Methods include determining a constituent level within a fluid using a diagnostic test device that includes the electrode, strip contact, individually isolated contacting pad arrangement, and a distinct pattern formed at least in part by the electrical insulating material disposed over the entire surface of at least one of the contacting pads. After connecting the distal region of the strip to a constituent level meter, applying a fluid sample to the reagent layer, taking a measurement using the plurality of electrodes, and identifying particular data based on the distinct pattern, calculating the fluid constituent concentration is performed based on a value of measured current and the data.
A method of making a plurality of test strips forms test strip structures on one sheet and separates them into individual test strips, including disposing insulating material over at least an entire surface of one of the contacting pads.
Claims Coverage
The claim set includes four independent claims, and the main inventive coverage centers on a distinct machine-readable code pattern using individually electrically isolated contacting pads, including a grounding contacting pad, and electrical insulating material portions, together with reagent and measurement based on electrodes and measured current.
Grounding contacting pad with proximal grounding portion and distal notch portion
At least one contacting pad is a grounding contacting pad configured to establish a common connection to an electrical ground, including a proximal grounding portion and a distal notch portion electrically separated from the grounding portion, with a distal edge of the grounding portion positioned proximally relative to distal edges of the remaining contacting pads.
Individually electrically isolated contacting pads forming a distinct machine-readable pattern
A set of individually electrically isolated contacting pads is provided distal to the electrical strip contacts, and a machine-readable pattern readable to identify data particular to the strip is 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.
Reagent layer contacting electrodes in proximal region
A reagent layer contacts at least a portion of at least one electrode disposed on the insulating layer at a proximal region of the strip.
Constituent concentration calculation based on measured current and identified data
A measurement is taken using the plurality of electrodes, particular data is identified based on the distinct pattern formed at least in part by electrical insulating material disposed over the entire surface of at least one of the electrical strip contacts, and the fluid constituent concentration is calculated based on a value of measured current and the data.
Forming test strip structures on one sheet and separating into a plurality of test strips
A plurality of test strip structures are formed on one sheet, including insulating layer, conductive pattern with electrodes and electrical strip contacts, individually electrically isolated contacting pads including a grounding contacting pad with proximal grounding portion and distal notch portion, and an insulating-material portion disposed over at least an entire surface of one of the contacting pads, and the test strip structures are separated into individual test strips.
Selectively covering an entire surface of an electrical strip contact with discrete insulating material
At least one of the electrical strip contacts is selectively covered 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.
Across the independent claims, the inventive coverage focuses on electrode-based electrochemical measurement paired with a distinct, machine-readable data pattern formed using individually isolated contacting pads and discrete electrical insulating material portions, including a grounding contacting pad with a proximal grounding portion and a distal notch portion; related methods cover constituent determination and manufacturing approaches using sheet-based formation and separation or selective insulating-material coverage.
Stated Advantages
Documented Applications
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