Patent US5260221A successfully refreshed from Google Patents.
US5260221A
Expired / Lapsed
US
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Sample pad assay initiation device
Assignee: Individual
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Filing: 1991-07-02
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Granted: 1993-11-09
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Expires: 2011-07-02
Abstract
Abstract A self-contained assay device is provided, where an analyte may be detected or be quantitated by measuring the distance of a detectable signal from a predetermined site. The device employs two strips separated by a gap, where a flow path is completed by movement of a sample receiving pad into the gap. The movement of the sample receiving pad also results in release of a reagent solution which is then transported through the pad into the quantitation area where the amount of analyte may be determined. Various chemistries may be employed for providing a detectable signal.
Inventors
- 👤 Urs A. Ramel
- 👤 Michael P. Allen
- 👤 Prithipal Singh
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-08 14:09
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/525; B; B01; B01L; B01L3/00; B01L3/50; B01L3/502; B01L3/5023; C; C12; C12Q; C12Q1/00; C12Q1/26; C12Q1/54; C12Q1/60; B01L2200/00; B01L2200/06; B01L2200/0621; B01L2200/16; B01L2300/00; B01L2300/06; B01L2300/0672; B01L2400/00; B01L2400/06; B01L2400/0677; B01L2400/0683; Y; Y10; Y10S; Y10S435/00; Y10S435/81; Y10T; Y10T436/00; Y10T436/25; Y10T436/25375
Claims Analysis
Total Claims: 10
Claim 1
Independent Claim
315 words
An analyte measuring device which cooperates with a signal producing system for producing a detectable signal in a detection zone, said device comprising: a housing comprising a well adjacent to one end of said housing, a pouch enclosing a liquid for release into said well, a flow path for holding in position two bibulous strips spaced apart in tandem relationship to define a space, and proximal to said well an interspace for receiving a slide mechanism; an orifice for receiving a sample displaced from and substantially aligned with the space between said two bibulous strips; in said orifice for preparing plasma free of red blood cells from blood with minimal lysis of said red blood cells, a membrane system comprising first and second membranes, said first membrane being a coarse separation membrane, having a pore size greater than said second membrane; said second membrane in fluid-receiving relationship with said first membrane and having an average porosity in the range of about 0.65μ to 7μ, or an asymmetric membrane having a maximum porosity of greater than about 40μ and a minimum porosity of not less than about 0.4μ; a slide element in said interspace comprising: (1) a sample receiving element positioned (i.) under said orifice when said slide element is in a first position, and (ii.) positioned in said space, when said slide is in a second position; and means for releasing a liquid into said well when said slide is moved from said first position to said second position; and first and second bibulous strips in said flow path, said first strip extending from said well to said space to transport liquid from said well to said sample receiving element and said second strip comprising said detection zone and extending from said space toward the end opposite from said well, wherein said second strip has non-diffusibly bound at least one member of said signal-producing system.
Claim 2
Dependent Claim
315 words
An analyte measuring device which cooperates with a signal producing system for producing a detectable signal in a detection zone, said device comprising: a housing comprising a well adjacent to one end of said housing, a pouch enclosing a liquid for release into said well, a flow path for holding in position two bibulous strips spaced apart in tandem relationship to define a space, and proximal to said well an interspace for receiving a slide mechanism; an orifice for receiving a sample displaced from and substantially aligned with the space between said two bibulous strips; in said orifice for preparing plasma free of red blood cells from blood with minimal lysis of said red blood cells, a membrane system comprising first and second membranes, said first membrane being a coarse separation membrane, having a pore size greater than said second membrane; said second membrane in fluid-receiving relationship with said first membrane and having an average porosity in the range of about 0.65μ to 7μ, or an asymmetric membrane having a maximum porosity of greater than about 40μ and a minimum porosity of not less than about 0.4μ; a slide element in said interspace comprising: (1) a sample receiving element positioned (i.) under said orifice when said slide element is in a first position, and (ii.) positioned in said space, when said slide is in a second position; and means for releasing a liquid into said well when said slide is moved from said first position to said second position; and first and second bibulous strips in said flow path, said first strip extending from said well to said space to transport liquid from said well to said sample receiving element and said second strip comprising said detection zone and extending from said space toward the end opposite from said well, wherein said second strip has non-diffusibly bound at least one member of said signal-producing system.
Claim 3
Dependent Claim
45 words
A device according to claim 1, wherein said first membrane is a glass fiber membrane wherein the diameter of said glass fiber is in the range of about 0.5-9μ and the density of said membrane is in the range of about 50-150 g/m 2 .
Claim 4
Dependent Claim
19 words
A device according to claim 1, wherein said second membrane has a porosity in the range of about 1-5μ.
Claim 5
Dependent Claim
361 words
An analyte measuring device which cooperates with a signal producing system for producing a detectable signal in a detection border, said device comprising: a housing comprising a well adjacent to one end of said housing, a pouch enclosing a liquid for release into said well, a flow path for holding in position two bibulous strips spaced apart in tandem relationship to define a space, and proximal to said well an interspace for receiving a slide mechanism; an orifice for receiving a sample displaced from and substantially aligned with the space between said two bibulous strips; in said orifice for preparing plasma free of red blood cells from blood with minimal lysis of said red blood cells, a membrane system comprising first and second membranes, said first membrane being a coarse separation membrane, having a pore size greater than said second membrane; said second membrane in fluid-receiving relationship with said first membrane having an average porosity in the range of about 0.65μ to 7μ, or an asymmetric membrane having a maximum porosity of greater than about 40μ and a minimum porosity of not less than about 0.4μ; a slide element in said interspace comprising: (1) a sample receiving element positioned (i.) under said orifice when said slide element is in a first position, and (ii.) positioned in said space, when said slide is in a second position, said sample receiving element comprising a member of said signal producing system non-diffusively bound; and means for opening a pouch when said slide is moved from said first position to said second position; means for removing excess sample from said sample receiving element as said sample receiving element moves from said first position to said second position; and first and second bibulous strips in said flow path, said first strip extending from said well to said space to transport liquid from said well to said sample receiving element and said second strip extending from said space toward the end opposite from said well comprising a measuring region in which a member of said signal producing system is non-diffusibly bound, wheren said member is at least one of a component of a dye or an enzyme.
Claim 6
Dependent Claim
361 words
An analyte measuring device which cooperates with a signal producing system for producing a detectable signal in a detection border, said device comprising: a housing comprising a well adjacent to one end of said housing, a pouch enclosing a liquid for release into said well, a flow path for holding in position two bibulous strips spaced apart in tandem relationship to define a space, and proximal to said well an interspace for receiving a slide mechanism; an orifice for receiving a sample displaced from and substantially aligned with the space between said two bibulous strips; in said orifice for preparing plasma free of red blood cells from blood with minimal lysis of said red blood cells, a membrane system comprising first and second membranes, said first membrane being a coarse separation membrane, having a pore size greater than said second membrane; said second membrane in fluid-receiving relationship with said first membrane having an average porosity in the range of about 0.65μ to 7μ, or an asymmetric membrane having a maximum porosity of greater than about 40μ and a minimum porosity of not less than about 0.4μ; a slide element in said interspace comprising: (1) a sample receiving element positioned (i.) under said orifice when said slide element is in a first position, and (ii.) positioned in said space, when said slide is in a second position, said sample receiving element comprising a member of said signal producing system non-diffusively bound; and means for opening a pouch when said slide is moved from said first position to said second position; means for removing excess sample from said sample receiving element as said sample receiving element moves from said first position to said second position; and first and second bibulous strips in said flow path, said first strip extending from said well to said space to transport liquid from said well to said sample receiving element and said second strip extending from said space toward the end opposite from said well comprising a measuring region in which a member of said signal producing system is non-diffusibly bound, wheren said member is at least one of a component of a dye or an enzyme.
Claim 7
Dependent Claim
13 words
A device according to claim 4, wherein said enzyme member is a peroxidase.
Claim 8
Independent Claim
264 words
A method for detecting the presence of an analyte in a blood sample employing a signal producing system having a plurality of reagents being distributed between being bound non-diffusibly to a surface or free in solution, said signal producing system with said analyte producing a detectable signal in a detection zone on a measuring strip employed as a said surface, said method comprising: placing said blood sample, wherein said filtering element is a membrane system comprising first and second membranes, said first membrane being a coarse separation membrane, having a pore size greater than said second membrane; said second membrane in fluid-receiving relationship with said first membrane and having an average porosity in the range of about 0.65μ to 7μ or an asymmetric membrane having a maximum porosity of not greater than about 40μ and a minimum porosity of not less than about 0.4μ over a filtering element which removes red blood cells from said blood sample to provide a plasma sample; applying said plasma sample to a sample receiving element capable of moving from a first position to a second position, said second position in liquid transferring relationship with said measuring strip; moving said sample receiving element to said second position; transporting fluid to said sample receiving element for transporting at least one member of said signal producing system from said sample receiving element to said measuring strip; and allowing said fluid to wick through said measuring strip with formation of a detectable boundary at a distance from said sample receiving element in relation to the amount of analyte in said blood sample.
Claim 9
Independent Claim
264 words
A method for detecting the presence of an analyte in a blood sample employing a signal producing system having a plurality of reagents being distributed between being bound non-diffusibly to a surface or free in solution, said signal producing system with said analyte producing a detectable signal in a detection zone on a measuring strip employed as a said surface, said method comprising: placing said blood sample, wherein said filtering element is a membrane system comprising first and second membranes, said first membrane being a coarse separation membrane, having a pore size greater than said second membrane; said second membrane in fluid-receiving relationship with said first membrane and having an average porosity in the range of about 0.65μ to 7μ or an asymmetric membrane having a maximum porosity of not greater than about 40μ and a minimum porosity of not less than about 0.4μ over a filtering element which removes red blood cells from said blood sample to provide a plasma sample; applying said plasma sample to a sample receiving element capable of moving from a first position to a second position, said second position in liquid transferring relationship with said measuring strip; moving said sample receiving element to said second position; transporting fluid to said sample receiving element for transporting at least one member of said signal producing system from said sample receiving element to said measuring strip; and allowing said fluid to wick through said measuring strip with formation of a detectable boundary at a distance from said sample receiving element in relation to the amount of analyte in said blood sample.
Claim 10
Dependent Claim
11 words
A method according to claim 6, wherein said analyte is cholesterol.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1996-11-08 | 1997-05-10 | 1997-11-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2000-11-08 | 2001-05-10 | 2001-11-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2004-11-08 | 2005-05-10 | 2005-11-09 | $7700.00 | Window Closed / Lapsed |