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US6991940B2 Expired / Lapsed US ⏱️ 0.0 years remaining

Diagnostic sanitary test strip

Assignee: Trividia Health Inc
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Filing: 2001-10-31
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Granted: 2006-01-31
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Expires: 2021-10-31
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Abstract

Abstract An improved multi-layered diagnostic sanitary test strip for receiving a heterogenous fluid, such as whole blood, to test for presence and/or amount of a suspected analyte in the fluid by facilitating a color change in the strip corresponding to the amount of the analyte in the fluid, wherein the test strip includes fluid volume control dams to prevent spillage of the fluid from the strip and a chemical reagent solution that facilitates end-point testing. The improved test strip comprises no more than two operative layers and: (a) a reaction membrane containing a reagent capable of reacting with the analyte of interest to produce a measurable change in said membrane; (b) an upper support layer defining a sample receiving port for receiving the fluid sample thereat; (c) one or more structures for directing the sample containing the analyte of interest through at least a portion of said reaction membrane; and (d) a lower support layer having a reaction viewing port in vertical alignment with said membrane for displaying said measurable change, said lower support being associated with said upper support to secure said reaction membrane in said test strip.

Inventors

  • 👤 Patrick Carroll
  • 👤 Jon Schneider
  • 👤 Douglas E. Bell

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-05 01:51
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/525; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/81; Y10S435/97; Y10S436/00; Y10S436/805; Y10S436/807; Y10S436/81; Y10S436/815; Y10S436/827

Claims Analysis

Total Claims: 29
Claim 1
Independent Claim 146 words
A diagnostic sanitary test strip device having a unitary construction for measuring an analyte of interest in a heterogeneous fluid sample, said test strip comprising: no more than two operative layers, one of said no more than two operative layers comprising a reaction membrane containing a reagent capable of reacting with the analyte of interest to produce a measurable change in said membrane; said test strip further comprising: an upper support layer defining a sample receiving port for receiving the fluid sample thereat; one or more structures for directing the sample containing the analyte of interest through at least a portion of said reaction membrane; and a lower support layer having a reaction viewing port in vertical alignment with said membrane for displaying said measurable change, said lower support layer being associated with said upper support layer to secure said reaction membrane in said test strip.
Claim 2
Dependent Claim 146 words
A diagnostic sanitary test strip device having a unitary construction for measuring an analyte of interest in a heterogeneous fluid sample, said test strip comprising: no more than two operative layers, one of said no more than two operative layers comprising a reaction membrane containing a reagent capable of reacting with the analyte of interest to produce a measurable change in said membrane; said test strip further comprising: an upper support layer defining a sample receiving port for receiving the fluid sample thereat; one or more structures for directing the sample containing the analyte of interest through at least a portion of said reaction membrane; and a lower support layer having a reaction viewing port in vertical alignment with said membrane for displaying said measurable change, said lower support layer being associated with said upper support layer to secure said reaction membrane in said test strip.
Claim 3
Dependent Claim 23 words
A test strip of claim 1 , further comprising a plurality of dam partitions defined by indentations formed in said upper support layer.
Claim 4
Dependent Claim 17 words
A test strip of claim 2 , wherein said dam partitions are oriented around said receiving port.
Claim 5
Dependent Claim 26 words
A test strip of claim 2 wherein said upper support layer comprises at least one detent for mating with securing posts in a corresponding reflectance meter.
Claim 6
Dependent Claim 24 words
A test strip of claim 2 , wherein said reagent in said reaction membrane is capable of detecting cholesterol analytes in the fluid sample.
Claim 7
Dependent Claim 24 words
A test strip of claim 2 , wherein said reagent in said reaction membrane is capable of detecting osteoporosis analytes in the fluid sample.
Claim 8
Dependent Claim 24 words
A test strip of claim 2 , wherein said reagent in said reaction membrane is capable of detecting ketones analytes in the fluid sample.
Claim 9
Dependent Claim 24 words
A test strip of claim 2 , wherein said reagent in said reaction membrane is capable of detecting theophylline analytes in the fluid sample.
Claim 10
Dependent Claim 24 words
A test strip of claim 2 , wherein said reagent in said reaction membrane is capable of detecting H1AC analytes in the fluid sample.
Claim 11
Dependent Claim 23 words
A test strip of claim 2 , further comprising indicia of proper orientation and insertion of said test strip in a corresponding meter.
Claim 12
Dependent Claim 24 words
A test strip of claim 10 , wherein said indicia comprises a light absorption medium on an exposed surface of said upper support layer.
Claim 13
Dependent Claim 24 words
A test strip of claim 10 , wherein said indicia comprises an arrow on said upper support layer to indicate proper direction of insertion.
Claim 14
Dependent Claim 24 words
A test strip of claim 2 , wherein said reagent in said reaction membrane is capable of detecting fructosamine analytes in the fluid sample.
Claim 15
Dependent Claim 23 words
A test strip of claim 2 wherein said dam partitions comprise four dam partitions positioned approximately 90° apart around a sample receiving port.
Claim 16
Dependent Claim 14 words
A test strip of claim 1 wherein said sample receiving port is substantially circular.
Claim 17
Dependent Claim 22 words
A test strip of claim 1 , wherein said reagent comprises reactants that facilitate an end-point test in a corresponding reflectance meter.
Claim 18
Dependent Claim 14 words
A test strip of claim 16 , wherein said reagent includes an enzyme solution.
Claim 19
Dependent Claim 33 words
A test strip of claim 1 , wherein one of said no more than two operative layers comprises a red blood cell binding agent for capturing red blood cells from the fluid sample.
Claim 20
Dependent Claim 16 words
A test strip of claim 18 , wherein said red blood cell binding agent comprises lectins.
Claim 21
Dependent Claim 31 words
A test strip of claim 19 , wherein said reagent in said reaction membrane includes an indicator chemical capable of visually indicating the amount of glucose analytes in the fluid sample.
Claim 22
Dependent Claim 24 words
A test strip of claim 1 , wherein said reagent in said reaction membrane is capable of detecting glucose analytes in the fluid sample.
Claim 23
Dependent Claim 24 words
A test strip of claim 1 , wherein said reaction membrane comprises an isotropic membrane such that said membrane has a substantially uniform porosity.
Claim 24
Dependent Claim 15 words
A test strip of claim 22 , wherein said membrane comprises a material containing polysulfone.
Claim 25
Dependent Claim 23 words
A test strip of claim 1 , wherein said measurable change in said reagent corresponds to the amount of analyte of interest present.
Claim 26
Dependent Claim 75 words
A test strip of claim 1 , wherein said no more than two operative layers further comprises a separating layer, in contiguous contact with said reaction membrane, for receiving the sample containing the analyte of interest from said sample receiving port, said separating layer having mesh openings and being treated with a chemical solution for separating at least one undesirable element from the fluid sample prior to passing the fluid sample through said mesh openings.
Claim 27
Dependent Claim 27 words
A test strip of claim 25 , wherein said chemical solution comprises a red blood cell binding agent for capturing red blood cells from the fluid sample.
Claim 28
Dependent Claim 15 words
A test strip of claim 25 , wherein said separating layer overextends said reaction membrane.
Claim 29
Dependent Claim 20 words
A test strip of claim 1 , having dimensions capable of accommodating sample volume of about 3 μl or less.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2009-01-30 2009-08-01 2010-01-31 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2013-01-30 2013-08-01 2014-01-31 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2017-01-30 2017-08-01 2018-01-31 $7700.00 Window Closed / Lapsed

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