Diagnostics instrument
First Claim
1. An automated diagnostics instrument for analyzing samples in test packs for analytes, said instrument comprising:
- processing station means for expressing and mixing reagents with samples in test packs to form optically detectable analytes and for separating and sealing waste portions of said samples from said analytes in waste pouches of said test packs;
sensing means for optically detecting said analytes;
carousel means for holding an array of test packs in an upright position and for intermittently and arcuately moving said test packs past said sensing means so that said sensing means can optically detect changing transitory optical characteristics of and confirm detection of said analytes at selected periodic intervals;
temperature control means for controlling the temperature of said samples including incubating means for heating the array of upright test packs in said carousel means and heating means for heating said test packs in said processing stations means;
processing tram means for moving said test packs from said carousel means to said processing station means and vice versa;
load door station means for ingress and egress of test packs;
load tram means for transporting said test packs from said load door station means to said carousel means and vice versa;
at least one of said tram means comprising a belt conveyor and a shuttle secured to said belt conveyor for detachably holding said test packs in an upright position; and
said test packs comprising;
closed disposable packs having burstable blisters containing reagents for desired tests, said closed disposable packs comprising flexible light transmissible plastic having portions for viewing said reagents and samples;
impact resistant trays comprising backing plates for matingly engaging and rigidly securing said closed disposable packs, said trays defining a window-receiving opening in alignment with read cells and having horizontally slotted upper carrier portions and lower carrier portions, and said trays having posts secured to said closed disposable packs; and
thermally conductive plates secured to said posts of said trays and engaging said closed disposable packs about said read cells.
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Accused Products
Abstract
A dependable cost-effective clinical analyzer machine provides an efficient and easy-to-use diagnostics instrument and process to accurately, rapidly and automatically test and analyze samples in test packs for an analyte. In the clinical analyzer machine, remote-controlled trams transport test packs containing loading/unloading station to a processing/testing station via a carousel and vice versa. In the processing station, a special processor with mechanically-operated rollers mixing shoes, wastegate assembly, magnets, clamp plate and a thermal sealer, process samples in test packs with various reagents to detect an analyte. The carousel holds the test packs during incubation periods and rotates the tested disposable packs past an optical reader which optically senses the presence of an analyte in the sample. Bar code readers are provided to assist in identification of the test pack, patient and sample.
509 Citations
10 Claims
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1. An automated diagnostics instrument for analyzing samples in test packs for analytes, said instrument comprising:
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processing station means for expressing and mixing reagents with samples in test packs to form optically detectable analytes and for separating and sealing waste portions of said samples from said analytes in waste pouches of said test packs; sensing means for optically detecting said analytes; carousel means for holding an array of test packs in an upright position and for intermittently and arcuately moving said test packs past said sensing means so that said sensing means can optically detect changing transitory optical characteristics of and confirm detection of said analytes at selected periodic intervals; temperature control means for controlling the temperature of said samples including incubating means for heating the array of upright test packs in said carousel means and heating means for heating said test packs in said processing stations means; processing tram means for moving said test packs from said carousel means to said processing station means and vice versa; load door station means for ingress and egress of test packs; load tram means for transporting said test packs from said load door station means to said carousel means and vice versa; at least one of said tram means comprising a belt conveyor and a shuttle secured to said belt conveyor for detachably holding said test packs in an upright position; and said test packs comprising; closed disposable packs having burstable blisters containing reagents for desired tests, said closed disposable packs comprising flexible light transmissible plastic having portions for viewing said reagents and samples; impact resistant trays comprising backing plates for matingly engaging and rigidly securing said closed disposable packs, said trays defining a window-receiving opening in alignment with read cells and having horizontally slotted upper carrier portions and lower carrier portions, and said trays having posts secured to said closed disposable packs; and thermally conductive plates secured to said posts of said trays and engaging said closed disposable packs about said read cells. - View Dependent Claims (2, 3, 4, 5, 6)
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7. An automated diagnostics instrument for analyzing samples in test packs for analytes, said instrument comprising:
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a loading station having a loading door for sequentially loading and unloading a series of test packs; said test packs comprising closed disposable packs having burstable blisters containing reagents for selected tests, reaction areas and waste pouches, said closed disposable packs comprising flexible transparent plastic for viewing the reagents and samples contained in the packs, and said closed disposal packs having read cells for containing and displaying optically detectable analytes; impact resistant trays comprising plastic back plates having closed disposable pack-receiving surfaces complementary in shape to portions of said disposable packs for matingly engaging and rigidly supporting said closed disposable packs, said trays defining window-receiving openings in alignment with said read cells and having horizontally slotted upper carrier portions and lower carrier portions, and said trays having posts secured to said closed disposable packs; thermally conductive plates secured to said posts of said trays and engaging said closed disposable packs about said read cells for conducting heat to enhance amplification; labels attached to said trays, said labels having bar codes corresponding to a desired test and identification of the samples and patient; at least one bar code reader adjacent said loading station for scanning and reading the bar codes on said test packs to identify the samples and tests; a carousel having slotted upper and lower platters comprising an eccentrically slotted upper disk and an eccentrically slotted spring-loaded lower disk, said upper and lower disk defining eccentric slots aligned in substantial vertical registration with each other for receiving and engaging said upper and lower carrier portions of said trays to hold said test packs in upright positions, a driven gear and a base positioned below and secured to said lower disk, a substantially vertical central shaft extending between and connecting said upper and lower disk and secured to said driven gear to rotate the carousel and platters holding said test packs; an optical detector comprising a movable optical read head position in proximity to the base of said carousel for contacting said read windows to read and sense optically-detectable analytes in the read cells of the test packs; a processing station for automatically expressing and mixing reagents with samples in said test packs, said processing station comprising pneumatically operated magnets for engaging said trays and magnetically attracting metallic beads in said test packs carrying said optically detectable analytes; an upright wastegate assembly for opening and closing waste pouches in the disposable closed packs; a substantially vertically moveable saddle assembly comprising a roller assembly having substantially horizontally reciprocating cam-driven rollers for mixing reagents and samples in reaction areas of the closed disposable packs and for moving background material comprising waste portions of the samples to waste pouches in the closed disposable packs; a mixer assembly having substantially horizontally reciprocating cam-driven impact members comprising shoes for manipulating and mixing reagents in blisters in said closed disposable closed packs and for breaking the blisters to express reagents from the blisters to the reaction areas of said closed disposable packs; a sealer assembly having substantially horizontally reciprocating cam-driven sealers including a side sealer for heat sealing substantially emptied reagent blisters and a reaction area sealer for heat sealing used substantially emptied vacated reaction areas and waste pouches containing the waste portions; and an upright belt conveyor assembly operatively connected to said saddle assembly for moving said saddle assembly substantially vertically so that said rollers shoes, and sealers can contact different areas of said closed disposable packs; a load tram for transporting said test trays from said loading station to said carousel; and a processing tram for transporting said test trays from said carousel to said processing station; and each of said trams having a pair of conveyor belts moveable in substantially horizontal planes, said belts including an upper conveyor belt and a lower conveyor belt, said belts being aligned in substantial vertical registration with each other, a set of pulleys including substantially horizontally positioned pulleys for driving and rotating said conveyor belts in substantially horizontally directions, and a shuttle having an upper bracket attached to said upper conveyor belt with a guide rail for securely engaging said slotted upper carrier portions of said trays and a lower bracket attached to said lower conveyor belt with portions for securely engaging said lower carrier portions of said trays, and said shuttle and said conveyor belts cooperating with each other for conveying and carrying said test packs in a substantial vertical position. - View Dependent Claims (8, 9, 10)
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Specification