Integrated testing device
Inventors
Kelly, John Michael • Siu, Eric • Norcott, Alison Ruth • Dunn, Christopher David • Johnson, Ian Frederick • Hueso, Ernesto Monis • Sokolov, Richard
Assignees
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Publication Number
US-10525463-B2
Publication Date
2020-01-07
Expiration Date
Abstract
An integrated testing device and method are disclosed. The device includes an integral reservoir for a test fluid, and an actuator, so that the test fluid can be dispensed to facilitate the test.
Core Innovation
An integrated disposable composite diagnostic system is described that includes a support member with at least one housing surface, a membrane penetration element, and test material positioned within the interior of the support member. A capillary tube extends from an opening outside the support member through the housing surface to an outlet within the interior to discharge onto the test material, and is adapted to take up a bodily fluid after it is released by application of the membrane penetration element and conduct the bodily fluid into contact with the test material.
The system further includes an internal reservoir located within the interior of the support member and adapted to contain a physiologically acceptable solution. A solution delivery actuator is arranged so that actuation causes the physiologically acceptable solution to be released from the reservoir and brought into contact with the test material after the bodily fluid has contacted the test material. Multiple embodiments are described, including buffer delivery to the test component or via channels/capillary tubes, with an integrated reservoir arrangement.
Embodiments are described with an integrated lancet for sampling and a membrane penetration element, in which a moveable lancet tip shifts between a rest position and an actuated position. Buffer is described as contained in sachets and in reservoir forms such as concertina, including rupture-under-force designs with seals and weakened seal regions. Optional sequencing cues/interlocks are described that prevent sample/buffer release out of order, and interfaces are described for removable test strip or cartridge analysis by diagnostic equipment.
Claims Coverage
The independent claim is claim 1, which defines a disposable composite diagnostic system that performs a bodily-fluid capture and delivery sequence followed by a subsequent physiologically acceptable solution delivery. The main inventive coverage centers on membrane-activated capillary bodily-fluid transport to test material and actuator-driven release of physiologically acceptable solution only after the bodily fluid has contacted the test material.
Membrane penetration to drive capillary bodily-fluid delivery to test material
The system includes a membrane penetration element and a capillary tube that extends from an opening outside the support member through the housing surface to an outlet within the interior for discharge onto the test material, wherein the capillary tube is adapted to take up a bodily fluid after it is released by application of the membrane penetration element and conduct the bodily fluid into contact with the test material.
Internal reservoir with actuator-controlled physiologically acceptable solution release after bodily-fluid contact
The system includes an internal reservoir adapted to contain a physiologically acceptable solution and a solution delivery actuator arranged such that actuation causes the physiologically acceptable solution to be released from the reservoir so that it is brought into contact with the test material after the bodily fluid has contacted the test material.
Moveable lancet tip with rest and actuated positions for membrane penetration
The membrane penetration element is provided in a lancing system in which a moveable lancet tip shifts from a rest position inside the support member to an actuated position extending beyond the support member exterior.
Sachet reservoir containing physiologically acceptable solution
The internal reservoir is specified as a sachet containing the physiologically acceptable solution.
Across the independent claim and its refinements described, the core coverage is a disposable composite diagnostic system that uses membrane penetration to enable capillary transport of a bodily fluid to test material, followed by actuator-driven release of a physiologically acceptable solution, including buffer embodiments and sachet reservoir embodiments. Additional structural refinements include a moveable lancet tip with rest and actuated positions and manually operable actuation, and embodiments described in the document include sequencing interlocks and diagnostic equipment interfacing for removable test components.
Stated Advantages
Provides release of physiologically acceptable solution from the internal reservoir so it is brought into contact with the test material after the bodily fluid has contacted the test material.
Buffer solution can be used as the physiologically acceptable solution.
A manually operated solution delivery actuator can be used.
A lancing system can be implemented using a moveable lancet tip with defined rest and actuated positions.
The internal reservoir can be implemented as a sachet containing the physiologically acceptable solution.
Optional sequencing cues/interlocks can prevent sample/buffer release out of order.
Documented Applications
Integrated diagnostic equipment analysis using a removable test strip or cartridge, including described interfaces for removable diagnostic equipment to analyze the results.
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