EP0212314A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Capillary flow device
Assignee: Roche Diagnostics Corp
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Filing: 1986-07-24
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Granted: —
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Expires: 2006-07-24
Abstract
Abstract Novel methods and devices are provided involving at least one chamber, at least one capillary, and at least one reagent involved in a system providing for a detectable signal As appropriate, the devices provide for measuring a sample, mixing the sample with reagents, defining a flow path, and reading the result. Of particular interest is the use of combinations of specific binding pair members which result in agglutination information, where the resulting agglutination particles may provide for changes in flow rate, light patterns of a flowing medium, or light absorption or scattering. A fabrication technique particularly suited for forming internal chambers in plastic devices is also described along with various control devices for use with the basic device.
Inventors
- 👤 Jimmy D. Allen
- 👤 Michael E. Cobb
- 👤 Robert S. Hillman
- 👤 Laura J. Winfrey
- 👤 Vladimir E. Ostoich
- 👤 Ian Gibbons
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-03 23:13
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/483; G01N33/487; G01N33/49; G01N33/4905; B; B01; B01F; B01F25/00; B01F25/40; B01F25/42; B01F25/43; B01F25/431; B01F25/4316; B01F25/433; B01F25/4338; B01F33/00; B01F33/30; B01F35/00; B01F35/71; B01F35/717; B01F35/7172; B01L; B01L3/00; B01L3/50; B01L3/502; B01L3/5027; B01L3/50273; B01L3/502746; B29; B29C; B29C65/00; B29C65/02; B29C65/08; B29C66/00; B29C66/01; B29C66/05; B29C66/302; B29C66/3022; B29C66/30223; B29C66/50; B29C66/51; B29C66/54; B29C66/70; B29C66/71; G01N21/00; G01N21/75; G01N21/77; G01N21/82; B01F21/00; B01F2101/00; B01F2101/23; B01F23/00; B01F23/50; B01F23/56; B01L2200/00; B01L2200/06; B01L2200/0689; B01L2300/00; B01L2300/08; B01L2300/0809; B01L2300/0816; B01L2300/0861; B01L2300/0887; B01L2400/00; B01L2400/04; B01L2400/0403; B01L2400/0406; B01L2400/06; B01L2400/0694; B29C45/00; B29C59/00; B29C59/16; B29C65/48; B29C65/4895; B29C66/90; B29C66/95; B29C66/951; B29C66/9513; B29K; B29K2055/00; B29K2055/02; B29L; B29L2031/00; B29L2031/756; G01N15/00; G01N15/10; G01N15/1012; G01N2015/1016; G01N21/01; G01N21/03; G01N2021/0346; G01N35/00; G01N2035/00465; G01N2035/00514; G01N21/17; G01N21/47; G01N21/49; G01N33/50; G01N33/53; G01N33/543; G01N33/54366; Y; Y10; Y10S; Y10S366/00; Y10S366/03; Y10S435/00; Y10S435/81
Claims Analysis
Total Claims: 21
Claim 1
Independent Claim
161 words
A method for determining an analyte in a fluid medium employing a device comprising at least one capillary unit acting as the motive force for moving the fluid medium in the device, at least one chamber unit, an inlet port, an outlet port distant from the inlet port, and a reagent contained within the device, said reagent being a member of a detection system, wherein said capillary acts as a metering pump and flow controller of the assay medium through said device to provide for a time controlled reaction with said reagent, said method comprising: introducing a fluid sample though said inlet port into one of said units and allowing said fluid sample to transit from one unit to the next unit at a rate controlled by said capillary unit and react with said reagent resulting in a detectable signal produced by said detection system; and determining said signal as a measure of the presence of said analyte in said sample.
Claim 2
Independent Claim
161 words
A method for determining an analyte in a fluid medium employing a device comprising at least one capillary unit acting as the motive force for moving the fluid medium in the device, at least one chamber unit, an inlet port, an outlet port distant from the inlet port, and a reagent contained within the device, said reagent being a member of a detection system, wherein said capillary acts as a metering pump and flow controller of the assay medium through said device to provide for a time controlled reaction with said reagent, said method comprising: introducing a fluid sample though said inlet port into one of said units and allowing said fluid sample to transit from one unit to the next unit at a rate controlled by said capillary unit and react with said reagent resulting in a detectable signal produced by said detection system; and determining said signal as a measure of the presence of said analyte in said sample.
Claim 3
Dependent Claim
22 words
A method according to Claim 1, wherein the detection system includes particles, and the passage of particles is observed by light scatter.
Claim 4
Dependent Claim
15 words
A method according to Claim 1, wherein at least one chamber unit includes a filter.
Claim 5
Independent Claim
149 words
A method for determining an analyte in a fluid medium employing a device comprising at least two capillary units, at least two chamber units, with two chamber units separated by a capillary unit, an inlet port, an outlet port distant from the inlet port, and a reagent bound to the surface of the device in chamber unit A, said reagent being a member of a detection system, wherein said capillary controls the rate of flow of the assay medium through said device to provide for a time controlled reaction with said reagent, said method comprising: introducing through said inlet port said fluid medium into a first chamber unit; transferring the fluid medium through a first capillary unit into said chamber unit A, whereby a reaction occurs initiating the production of said detectable signal; and detecting said signal as a measure of the presence of analyte in said fluid medium.
Claim 6
Independent Claim
149 words
A method for determining an analyte in a fluid medium employing a device comprising at least two capillary units, at least two chamber units, with two chamber units separated by a capillary unit, an inlet port, an outlet port distant from the inlet port, and a reagent bound to the surface of the device in chamber unit A, said reagent being a member of a detection system, wherein said capillary controls the rate of flow of the assay medium through said device to provide for a time controlled reaction with said reagent, said method comprising: introducing through said inlet port said fluid medium into a first chamber unit; transferring the fluid medium through a first capillary unit into said chamber unit A, whereby a reaction occurs initiating the production of said detectable signal; and detecting said signal as a measure of the presence of analyte in said fluid medium.
Claim 7
Dependent Claim
64 words
A method according to Claim 4, wherein said device has a third port proximal to the outlet of chamber unit A, wherein the transit of said fluid terminates at said third port to permit an incubation period, including the additional step of sealing said third port to permit continued movement of said fluid medium from said chamber unit A into the next capillary unit.
Claim 8
Dependent Claim
106 words
6 . A device for detecting the presence of an analyte in a fluid sample, comprising: a capillary unit capable of independently pumping a liquid as the sole motive source in said device; a chamber unit in fluid transfer relationship with said capillary unit; an inlet port and an exit port positioned remote from one another and included in different units; a reagent contained within the device, which is a member of a system capable of providing a detectable signal in relationship to the presence of said analyte; wherein the dimensions of said capillary provide for a time controlled reaction between said reagent and said analyte.
Claim 9
Dependent Claim
106 words
6 . A device for detecting the presence of an analyte in a fluid sample, comprising: a capillary unit capable of independently pumping a liquid as the sole motive source in said device; a chamber unit in fluid transfer relationship with said capillary unit; an inlet port and an exit port positioned remote from one another and included in different units; a reagent contained within the device, which is a member of a system capable of providing a detectable signal in relationship to the presence of said analyte; wherein the dimensions of said capillary provide for a time controlled reaction between said reagent and said analyte.
Claim 10
Dependent Claim
49 words
A device according to Claim 6, comprising at least two capillaries or chambers in fluid transfer relationship with said capillaries, wherein reagent is in at least one of said chambers and chambers are connected by capillaries, wherein the walls of said capillary are hydrophobic plastic treated to enhance hydrophilicity.
Claim 11
Dependent Claim
32 words
A device according to Claim 7 , including a third sealable port intermediate said inlet port and exit port and proximal to the juncture between a chamber unit and a capillary unit.
Claim 12
Dependent Claim
14 words
A device according to Claim 6, wherein a chamber unit includes a filtration device.
Claim 13
Independent Claim
168 words
A device for detecting the presence of an analyte in a fluid sample, comprising: a substantially hydrophobic housing having at least a portion of the walls treated to provide hydrophilicity, said housing comprising; a capillar unit having hydrophilic walls and capable of pumping a liquid as the sole motive source in said device; a chamber unit in fluid transfer relationship with said capillary unit; an inlet port and exit port positioned remote from one another and included in different units; a reagent bound to the surface of the device, which is a member of a system capable of providing a detectable signal in relation to the presence of said analyte; wherein the dimensions of said capillary provide for a time controlled reaction between said reagent and said analyte; said device being fabricated from two to three sheets, wherein at least one outer sheet provides orifices for communication of a unit to the atmosphere, and where three sheets are present, a middle sheet defines said chamber and capillary units.
Claim 14
Independent Claim
168 words
A device for detecting the presence of an analyte in a fluid sample, comprising: a substantially hydrophobic housing having at least a portion of the walls treated to provide hydrophilicity, said housing comprising; a capillar unit having hydrophilic walls and capable of pumping a liquid as the sole motive source in said device; a chamber unit in fluid transfer relationship with said capillary unit; an inlet port and exit port positioned remote from one another and included in different units; a reagent bound to the surface of the device, which is a member of a system capable of providing a detectable signal in relation to the presence of said analyte; wherein the dimensions of said capillary provide for a time controlled reaction between said reagent and said analyte; said device being fabricated from two to three sheets, wherein at least one outer sheet provides orifices for communication of a unit to the atmosphere, and where three sheets are present, a middle sheet defines said chamber and capillary units.
Claim 15
Dependent Claim
45 words
A device according to Claim 10, wherein said middle layer defines at least two chambers and at least two capillaries, one of said capillaries connecting first and second chambers, the other of said capillaries being serpentine and in fluid receiving relationship from said second chamber.
Claim 16
Dependent Claim
26 words
A device according to Claim 10, wherein one of said sheets is formed with said capillaries and chambers and the other sheet is a inner sheet.
Claim 17
Independent Claim
134 words
A method of fabricating a plastic device having an internal chamber formed therein, which comprises: injection molding at least two plastic pieces to be formed into said device, wherein the space that is to form said chamber is defined by a depression in a surface of at least one of said plastic pieces, wherein said plastic pieces are formed from acyrlonitrile- butadiene-styrene copolymers, and wherein said injection molding forms one or more ridges adjacent to the perimeter of said depression; modifying the surface of said depression by means of plasma etching or corona discharge; placing said pieces in proper register; and ultrasonically welding said plastic pieces for a controlled time until said ridge or ridges melt to form a physical bond between said plastic pieces that approaches but does not extend into said depression.
Claim 18
Independent Claim
134 words
A method of fabricating a plastic device having an internal chamber formed therein, which comprises: injection molding at least two plastic pieces to be formed into said device, wherein the space that is to form said chamber is defined by a depression in a surface of at least one of said plastic pieces, wherein said plastic pieces are formed from acyrlonitrile- butadiene-styrene copolymers, and wherein said injection molding forms one or more ridges adjacent to the perimeter of said depression; modifying the surface of said depression by means of plasma etching or corona discharge; placing said pieces in proper register; and ultrasonically welding said plastic pieces for a controlled time until said ridge or ridges melt to form a physical bond between said plastic pieces that approaches but does not extend into said depression.
Claim 19
Dependent Claim
137 words
A control device capable of detecting depletion of a particle-containing fluid from a sample reservoir in a device comprising a sample reservoir and a capillary exiting said reservoir, which comprises: a light source located so as to impinge on said fluid in said reservoir; a light detector located in close proximity to said capillary so as to collect light which is reflected by said particles into said capillary and thereafter further reflected by said particles so as to pass out through the walls of said capillary; a signal generator operably attached to said light source, wherein a detectable signal is imposed on the output of said light source; and a filter operably attached to the output of said light detector, wherein said detectable signal is isolated from other light sources which may impinge upon said light detector.
Claim 20
Dependent Claim
137 words
A control device capable of detecting depletion of a particle-containing fluid from a sample reservoir in a device comprising a sample reservoir and a capillary exiting said reservoir, which comprises: a light source located so as to impinge on said fluid in said reservoir; a light detector located in close proximity to said capillary so as to collect light which is reflected by said particles into said capillary and thereafter further reflected by said particles so as to pass out through the walls of said capillary; a signal generator operably attached to said light source, wherein a detectable signal is imposed on the output of said light source; and a filter operably attached to the output of said light detector, wherein said detectable signal is isolated from other light sources which may impinge upon said light detector.
Claim 21
Dependent Claim
27 words
The control device of Claim 14, wherein said light source produces infrared light and said detectable signal is a periodic variation in the intensity of said light.
References Cited (Backward Citations)
No citation records indexed.
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