LATERAL FLOW DIAGNOSTIC DEVICES WITH INSTRUMENT CONTROLLED FLUIDICS
First Claim
1. A micro-assay device comprising:
- a micro-reactor for sample fluid analysis;
a first fluidic element for introducing a sample fluid into the micro-reactor; and
an injector fluid pump for pushing the sample fluid along a sample fluid flow path of the micro reactor, the injector fluid pump includingan initially closed integral injector fluid reservoir containing an aqueous injector fluid;
an initially dry microporous injector fluid flow path having an injector fluid application end for accepting the injector fluid from the reservoir and an injector fluid effluent end for connecting to the sample fluid flow path, the injector fluid flow path automatically filling with the injector fluid up to the effluent end upon supply of the injector fluid to the injector fluid application end;
a valve for opening the reservoir and selectively supplying the injector fluid from the reservoir to the injector fluid application end;
an isolator for preventing passive injector fluid flow from the effluent injector fluid into the sample fluid flow path when the injector fluid flow path includes the injector fluid;
driving means for electro-osmotically pumping the injector fluid in the injector fluid flow path across the isolator to force the injector fluid into the sample fluid flow path, when the sample fluid flow path includes the sample fluid, for advancing the sample fluid in the sample fluid flow path by hydraulically pushing the sample fluid along the sample fluid flow path with the injector fluid; and
a sealing element for sealing the injector fluid flow path along a perimeter thereof to prevent flow of the injector fluid from the injector fluid flow path at the perimeter during electro-osmotic pumping of the injector fluid.
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Accused Products
Abstract
Devices with lateral flow elements and integral fluidics are disclosed. The integral fluidics consist of injector pumps comprised of fluidic elements under instrument control. The fluidic element of an injector pump is fluidically connected to lateral flow elements and can be used to control fluid entry into containment chambers referred to as micro-reactors. The lateral flow elements comprise conductor elements that can be used for sample application and transport of analyte contained in the sample to the micro-reactor. Fluidic transport through the fluidic element of the injector pump is under instrument-control. Both the lateral flow element and the fluidic element may contain chemical entities incorporated along their length. The chemical reactions that can be used for analyte detection using the devices are described. Also described are methods of manufacture of these devices.
79 Citations
35 Claims
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1. A micro-assay device comprising:
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a micro-reactor for sample fluid analysis; a first fluidic element for introducing a sample fluid into the micro-reactor; and an injector fluid pump for pushing the sample fluid along a sample fluid flow path of the micro reactor, the injector fluid pump including an initially closed integral injector fluid reservoir containing an aqueous injector fluid; an initially dry microporous injector fluid flow path having an injector fluid application end for accepting the injector fluid from the reservoir and an injector fluid effluent end for connecting to the sample fluid flow path, the injector fluid flow path automatically filling with the injector fluid up to the effluent end upon supply of the injector fluid to the injector fluid application end; a valve for opening the reservoir and selectively supplying the injector fluid from the reservoir to the injector fluid application end; an isolator for preventing passive injector fluid flow from the effluent injector fluid into the sample fluid flow path when the injector fluid flow path includes the injector fluid; driving means for electro-osmotically pumping the injector fluid in the injector fluid flow path across the isolator to force the injector fluid into the sample fluid flow path, when the sample fluid flow path includes the sample fluid, for advancing the sample fluid in the sample fluid flow path by hydraulically pushing the sample fluid along the sample fluid flow path with the injector fluid; and a sealing element for sealing the injector fluid flow path along a perimeter thereof to prevent flow of the injector fluid from the injector fluid flow path at the perimeter during electro-osmotic pumping of the injector fluid. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A diagnostic device with integral fluidics for detecting an analyte in a sample fluid, comprising:
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an electrically insulated substrate; a micro-reactor on the substrate; at least one lateral flow element for supplying to the micro-reactor a reporter-conjugate for forming an analyte-conjugate complex; a fluidic element for supplying sample fluid to the micro-reactor, and an injector pump for supplying reagent to a fluid receiving location of the micro-reactor, the injector fluid pump including an initially closed integral injector fluid reservoir containing an aqueous injector fluid; an initially dry microporous injector fluid flow path having an injector fluid application end for accepting the injector fluid from the reservoir and an injector fluid effluent end for connecting to the sample fluid flow path, the injector fluid flow path automatically filling with the injector fluid up to the effluent end upon supply of the injector fluid to the injector fluid application end; a valve for opening the reservoir and selectively supplying the injector fluid from the reservoir to the injector fluid application end; an isolator for preventing passive injector fluid flow from the injector fluid effluent end into the sample fluid flow path when the injector fluid flow path includes the injector fluid; driving means for electro-osmotically pumping the injector fluid in the injector fluid flow path across the isolator to force the injector fluid into the sample fluid flow path, when the sample fluid flow path includes the sample fluid, for advancing the sample fluid in the sample fluid flow path by hydraulically pushing the sample fluid along the sample fluid flow path with the injector fluid; and a sealing element for sealing the injector fluid flow path along a perimeter thereof to prevent flow of the injector fluid from the injector fluid flow path at the perimeter during electro-osmotic pumping of the injector fluid. - View Dependent Claims (24)
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25. An integral diagnostic device for testing the concentration of an analyte in a sample fluid, comprising
a micro-reactor for capturing an analyte-conjugate complex; -
a substrate with a primary lateral flow element for transport of analyte in a sample fluid to the micro-reactor; and at least one supplemental flow path for supplying a reagent to the micro-reactor, the supplemental flow path being an injector pump, the injector fluid pump including an initially closed integral injector fluid reservoir containing an aqueous injector fluid; an initially dry microporous injector fluid flow path having an injector fluid application end for accepting the injector fluid from the reservoir and an injector fluid effluent end for connecting to the sample fluid flow path, the injector fluid flow path automatically filling with the injector fluid up to the effluent end upon supply of the injector fluid to the injector fluid application end; a valve for opening the reservoir and selectively supplying the injector fluid from the reservoir to the injector fluid application end; an isolator for preventing passive injector fluid flow from the injector fluid effluent end into the sample fluid flow path when the injector fluid flow path includes the injector fluid; driving means for electro-osmotically pumping the injector fluid in the injector fluid flow path across the isolator to force the injector fluid into the sample fluid flow path, when the sample fluid flow path includes the sample fluid, for advancing the sample fluid in the sample fluid flow path by hydraulically pushing the sample fluid along the sample fluid flow path with the injector fluid; and a sealing element for sealing the injector fluid flow path along a perimeter thereof to prevent flow of the injector fluid from the injector fluid flow path at the perimeter during electro-osmotic pumping of the injector fluid.
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26. A diagnostic device, comprising
a card body an initially dry, micro-porous fluidic path mounted in the card body with a fluid application end and an effluent end; -
a sealed fluid reservoir also mounted on the card body a valve for selectively opening the sealed fluid reservoir for releasing stored fluid from the reservoir; and a conduit for supplying the fluid released by the fluid chamber to the application end of the micro-porous fluidic path.
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27. A diagnostic device, comprising
a lateral flow strip including a sample application end and an effluent end and at least one fluid receiving location along its length for receiving fluid from an instrument controlled fluid injector; - and an enclosed air chamber at the fluid receiving location.
- 28. A micro-fluidic device with at least one electroosmotic pump, comprising a fluidic path whose surface has a zeta potential, electrically connected to a pair of spaced apart electrodes at two spaced apart electrode locations, wherein the spaced apart electrodes are formed on one side of an insulating substrate and are electrically connected through the substrate to two spaced apart contact locations formed on the other side of the insulating substrate for connection to an external instrument means for generating an electrical potential across the electrodes.
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30. An injector fluid pump for pushing an aqueous injector fluid to a downstream of a micro-porous flow path, comprising:
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an initially dry injector fluid flow path having an injector fluid application end for accepting the injector fluid and an injector fluid effluent end for delivering the injector fluid to the receiving location, the injector fluid flow path automatically filling with the injector fluid up to the injector fluid effluent end upon injector fluid application to the injector fluid application end; an isolator for fluidically isolating the injector fluid effluent end from the receiving location to prevent passive injector fluid flow from the injector fluid effluent end when the injector fluid flow path includes injector fluid; driving means for electro-osmotically pumping the injector fluid out of the injector fluid effluent end and across the isolator to the injector fluid receiving location of the downstream flow path; and a sealing element for sealing the injector fluid flow path along a perimeter thereof to prevent injector fluid flow from the injector fluid flow path at the perimeter during electro-osmotic pumping. - View Dependent Claims (31, 32, 34, 35)
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Specification