US20220308078A1

US 20220308078A1
IN
( 19) United States
( 12)) Stein
Patent Application Publication ((4310)) Pub
Pub.. Date
No .: :US 2022/0308078 A1
et al . Sep. 29 , 2022
( 54 ) AUTOMATED CLINICAL ANALYZER ( 60 ) Provisional application No. 62/ 365,314 , filed on Jul .
SYSTEM AND METHOD 21 , 2016 .
( 71 ) Applicant: Siemens Healthcare Diagnostics Inc. ,
Tarrytown , NY (US ) Publication Classification
( 72 ) Inventors: David Stein , Succasunna , NJ (US ); Roy (51 ) Int . Ci .
Barr , Delaware, NJ (US ); Mark GOIN 35/00 ( 2006.01 )
Edwards , Armonk , NY (US ) ; Colin GOIN 35/04 (2006.01)
Mellars , Tucson, AZ (US ) ; Thomas J. GOIN 35/02 (2006.01 )
Bao , Livingston , NJ (US ); Charles V. (52) U.S. Ci.
Cammarata , Ledgewood , NJ (US ); CPC GOIN 35/0099 (2013.01 ) ; GOIN 35/04
Benjamin S. Pollack , Jersey City, NJ (2013.01 ) ; GOIN 35/026 ( 2013.01 ) ; GOIN
(US ) ; Baris Yagci, Montclair, NJ (US ) ; 1/00 ( 2013.01 )
Beri Cohen , Hartsdale , NY (US )
( 73 ) Assignee : Siemens Healthcare Diagnostics Inc. , ( 57 ) ABSTRACT
Tarrytown , NY (US )
( 21 ) Appl. No .: 17 /807,112 An analyzer system for in vitro diagnostics includes a
(22 ) Filed : Jun . 15 , 2022 sample handler module having a robot arm that delivers
Related U.S. Application Data samples from drawers into carriers on a linear synchronous
motor automation track . Samples are delivered via the
( 63 ) Continuation of application No. 16/ 319,306 , filed on automation track to individual track sections associated with
Jan. 18 , 2019 , now Pat . No. 11,378,583 , filed as individual analyzer modules. Analyzer modules aspirate
application No. PCT US2017
/ /042943 on Jul . 19 , sample portions directly from the sample carriers and per
2017 . form analysis thereon .
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US 2022/0308078 A1 Sep. 29, 2022
1
AUTOMATED CLINICAL ANALYZER track will move in the same direction at the same speed .
SYSTEM AND METHOD When a sample needs to exit the friction track, gating
switching can be used to move individual pucks into off
CROSS - REFERENCE TO RELATED shoot paths. A drawback with this set up is that singulation
APPLICATIONS must be used to control the direction of any given puck at
[ 0001 ] This application is a Continuation application of each gate and switch . For example, if two pucks are near one
U.S. patent application Ser. No. 16 /319,306 filed Jan. 18 , another, and only one puck should be redirected into an
2019 , which is a national phase entry of PCT International offshoot path , it becomes difficult to control aa switch so that
Patent Application No. PCT/US2017 / 042943 filed Jul . 19 , only one puck is moved into the offshoot path and ensure
2017 , which claims priority to , and the benefit of, U.S. that the proper puck is pulled from the friction track . This
Provisional Application No. 62 / 365,314 filed Jul . 21 , 2016 , has created the need in many prior art systems to have pucks
the disclosures of each of which applications are hereby
.
stop at a gate so that individual pucks can be released and
incorporated herein by reference in their entirety. switched , one at a time , at each decision point on a track .
[ 0005 ] Another way that singulation has been used in
TECHNOLOGY FIELD friction track -based systems is to stop the puck at a gate and
allow a barcode reader to read a barcode on the sample tube.
[ 0002 ] The present invention relates, in general, to a Because barcode readers are slow relative to the amount of
laboratory automation system and clinical chemistry ana time needed to switch a puck between tracks, scanning
lyzer system for use in a laboratory environment and, more introduces hard singulations into the flow on a track and
particularly, to systems and methods for handling, storing , causes all nearby pucks to halt while a switching determi
transporting, and testing patient samples for in vitro diag nation is made. After a determination is made , singulation
nostics in a clinical analyzer. may be further used to ensure that only the scanned puck
proceeds by using a physical blockage to prevent the puck
BACKGROUND behind the scanned puck from proceeding while the scanned
[ 0003 ] In vitro diagnostics (IVD ) allows labs to assist in puck is switched .
the diagnosis of disease based on assays performed on [ 0006 ] U.S. Pat. No. 6,202,829 shows an exemplary prior
patient fluid samples. IVD includes various types of ana art friction track system that includes actuated mechanical
lytical tests and assays related to patient diagnosis and diversion gates that can be used to direct pucks off of the
therapy that can be performed by analysis of a liquid sample main track onto pullout tracks. As explained therein , the
taken from a patient's bodily fluids, or abscesses . These diversion process can require multiple mechanical gates to
assays are typically conducted with automated clinical singulate and separate individual pucks , stopping each puck
chemistry analyzers ( analyzers ) onto which fluid containers, multiple times and allowing each puck to be rotated so that
such as tubes or vials , containing patient samples have been a barcode can be read before a diversion decision is made .
loaded . The analyzer extracts a liquid sample from the vial Such a system increases latency and virtually ensures that,
and combines the sample with various reagents in special each time a diversion gate is added to a friction track , the
reaction cuvettes or tubes ( referred to , generally, as reaction gate adds another traffic bottleneck . Such a system results in
vessels ) . In some conventional systems , a modular approach natural queuing at each diversion gate , further increasing the
is used for analyzers . A lab automation system can shuttle amount of time that each sample spends on the friction track .
samples between one sample processing module (module ) [ 0007] Friction tracks are also typically slow -moving .
and another module . Modules may include one or more Because all samples in pucks move together, these pucks
stations , including sample handling stations and analyzer routinely crash into one another and the track moves at the
modules /testing stations ( e.g. , a unit that can specialize in same speed around curves and straightaways. Moreover,
certain types of assays ) , or can otherwise provide testing stopping, singulating, and switching occur by a puck impact
services to the larger analyzer, which may include immu ing a stationary object, such as a diversion arm or stopping
noassay (IA) and clinical chemistry ( CC ) stations . Some point. As a result, friction tracks typically move at a rela
traditional IVD automation track systems comprise systems tively low velocity to prevent fluids contained in the open
that are designed to transport samples from one fully inde fluid sample containers in the pucks from splashing and
pendent module to another standalone module. This allows spilling onto laboratory equipment or the automation track .
different types of tests to be specialized in two different For large laboratory systems , it may take several minutes for
stations/modules, or allows two redundant stations to be a friction track to transport one sample puck from one end
linked to increase the volume of sample throughput avail of the room to another end of the room . This adds to overall
able . These lab automation systems, however, are often latency, and can increase traffic due to increased travel times ,
bottlenecks in multi - station analyzers . Relatively speaking, which can reduce the turnaround time or average throughput
traditional lab automation systems lack large degrees of of samples in a batch inserted into an analyzer and the
intelligence or autonomy to allow samples to independently automation system . Thus, there is aa need for a system that
move between stations . allows faster movement of samples and sample carriers
[ 0004 ] In an exemplary prior art system , a friction -based within the automation system .
track , much like a conveyor belt , shuttles individual carrier [ 0008 ] Traditional laboratory automation systems in ana
mechanisms, sometimes called pucks , or racks of containers , lyzers are operated by having an operator ( e.g. , a lab
between different stations. Samples may be stored in sample technician ) place trays of sample tubes into an input area .
containers, such as test tubes that are placed into a puck by These tubes typically have a vertical sticker placed on the
an operator or robot arm , for transport between stations in an side of them that includes a barcode and, optionally, human
analyzer along the track . This friction track , however, can readable identification that allow the system to verify the
only move in one direction at a time , and any samples on the identity of samples and to handle each sample accordingly.
US 2022/0308078 A1 Sep. 29, 2022
2
These trays are typically an array that allows several drawers located at a front of the sample handler module that
samples ( e.g. , typically around 50 samples) to be manually is accessible to a human operator, and one or more analyzer
carried by the operator. Because all of the samples in a tray modules configured to aspirate, using at least one pipette, a
are not necessarily processed in the same manner, samples portion of a patient sample from each of the plurality of
are removed from the tray via manual operation by the patient samples and perform a clinical analysis of at least
operator or via a robot arm in the system . These sample one of clinical chemistry characteristics and immunoassay
tubes are then placed into carriers (e.g. , plastic pucks ) that characteristics of that patient sample. The analyzer system
are already present or placed into the automation system further includes a plurality of sample carriers configured to
track . Because of the nature of traditional plastic pucks and accept at least one of the plurality of patient samples, each
the sample handling robotics used to move patient samples carrier having magnets in the base thereof and an automation
from trays to pucks , there is typically a restriction on the track comprising a plurality of track sections forming a
type of patient sample tubes that may be used . For example , plurality of branches, each track section having a surface
a clinical analyzer may require that patient samples arrive in that includes a plurality of synchronously controlled mag
a single type of patient sample tube having uniform dimen netic coils . The automation track is configured to move the
sions ( e.g. , uniform height and diameter of the glass or plurality of patient sample tubes in the plurality of sample
plastic making up the tube ). It may be undesirable to use a carriers via the synchronously controlled magnetic coils to
uniform patient sample tube size , particularly where there is propel the plurality of sample carriers along the plurality of
a variation in sources of the patient samples ( e.g. , a diag track sections . The automation track is configured to receive
nostic lab that receives patient samples from a variety of each of the plurality of patient sample tubes from the sample
clinical locations ) . handler module via a robot arm in the sample handler
[ 0009 ] Automation processes for handling input sample module and to move each patient sample tube to first
trays can be relatively slow because the identity of each location on the automation track accessible to the at least one
sample must be ascertained to identify whether or not the pipette of the one or more analyzer modules , to facilitate
sample is a STAT sample. STAT samples require immediate aspiration of the portion of the patient sample.
priority and may be handled differently by the automation [ 0012] According to one aspect of some embodiments, the
system , typically by flushing any physical queues of sample sample handler module comprises a plurality of cameras that
pucks ahead of a puck containing a STAT sample, allowing record overhead images of sample tubes in the drawers as
the STAT sample to freely move to its destination. Moreover, the drawers are closed by a human operator. According to
if a variety of patient sample tube sizes is being used , the end another aspect of some embodiments, the analyzer includes
effectors of robot arms must be careful in engaging tubes a station on the automation track having a plurality of
without knowing the size of the tube , relying on the cameras that observe each of the plurality of sample carriers
observed pressure to determine when it has properly to characterize the carrier and at least one of the plurality of
engaged the tube, much like feeling around in the dark . patient sample tubes after that patient sample tube has been
Thus, there exists a deficiency in the prior art with respect placed into the carrier. According to another aspect of some
to the sample handling input that might allow a variety of embodiments, the plurality of track sections receives pri
patient sample tube sizes to be used . mary power from one of the one or more analyzer modules
[ 0010 ] Traditional friction -based automation tracks may and backup power from an adjacent one of the one or more
also suffer from lack of redundancy. In a typical configura analyzer modules. According to another aspect of some
tion, a friction track is a standalone component that is bolted embodiments, the sample handler module comprises refrig
onto several modules , typically including a single power erated storage configured to store control and calibrator
supply, controller, etc. If any of these components fail, the fluids for multiple days. According to another aspect of some
entire automation system will shut down until it is serviced . embodiments, the analyzer further includes a plurality of
The track design also typically suffers from lack of com reagent carriers configured to accept a reagent cartridge and
pactness and lack of accessible paths to get between points to transport the reagent cartridge, via the automation track ,
in the automation track without taking the same main route to a second location accessible to the one or more analyzer
as every other sample the system . Each can create traffic modules .
jams , reduce the throughput, and increase overall latency [ 0013 ] According to one aspect of some embodiments, the
and turnaround time in the system . Furthermore, because automation track is configured such that the plurality of
samples spend an excessive amount of time sitting on a track sections form an outer loop on the perimeter of the one
friction track , samples may begin to degrade between being or more analyzer modules and a plurality of bypass track
input and when tests occur on the sample due to the long sections internal to the one or more analyzer modules that
wait times . Additionally, traditional bolt - on automation bypass the outer loop . The first location on the automation
tracks require samples be physically removed from the track accessible to the at least one pipette is on at least one
automation track by each station for interaction with that of the bypass track sections . According to another aspect of
patient sample. This adds to mechanical complexity and some embodiments, each of the one or more analyzer
overall latency of the system . modules is serviced by one of the bypass track sections , and
SUMMARY that bypass track section is configured to temporarily hold a
subset of the plurality of sample carriers for random access
[ 0011 ] Embodiments may address one or more of the by the at least one pipette . According to another aspect of
shortcomings of the prior art by using any of the following some embodiments , movement and random access of the
concepts. In one embodiment, an analyzer system for use in subset of the plurality of sample carriers on each of the
an in vitro diagnostics (IVD ) environment includes a sample bypass track sections is controlled responsive to a processor
handler module configured to accept a plurality of trays of the one or more analyzer modules. According to another
holding a plurality of patient sample tubes via one or more aspect of some embodiments , the outer loop is accessible to
US 2022/0308078 A1 Sep. 29, 2022
3
the sample handler module and the plurality of track sections [ 0026 ] FIG . 10B is a perspective view of an exemplary
form a bypass track section configured to allow sample cooling system for use with some embodiments;
carriers to travel around the perimeter of the one or more [ 0027] FIG . 10C is a side view of a door assembly of an
analyzer modules without returning to the sample handler exemplary cooling system for use with some embodiments;
module. [ 0028 ] FIG . 10D is a perspective view of a tube and cover
[ 0014 ] According to one aspect of some embodiments, at assembly of an exemplary cooling system for use with some
least one track section is accessible to an external laboratory embodiments;
automation system . According to another aspect of some [ 0029 ] FIG . 11 is a perspective view of an exemplary robot
embodiments, each of the plurality of sample carriers com arm for use with exemplary embodiments of the sample
prises a sample tube holder having two positions , and the handler;
sample handler module is configured to place a first one of [ 0030 ] FIG . 12 is a perspective view of an exemplary
the plurality of patient samples into the sample tube holder robot arm end effector assembly for use with exemplary
before removing a second one of the plurality of patient embodiments of the sample handler ;
samples from the sample tube holder. [ 0031 ] FIG . 13 is a perspective view of an exemplary
[ 0015 ] In one embodiment, a method for analyzing patient robot arm sensor assembly for use with exemplary embodi
samples includes steps of receiving, at a sample handler ments of the sample handler;
module , a plurality of trays holding a plurality of patient [ 0032 ] FIG . 14 is a perspective view of an exemplary
sample tubes via one or more drawers located at a front of automation track system for use with some embodiments ;
the sample handler module that is accessible to a human [ 0033 ] FIG . 15 is a perspective view of an exemplary
operator and providing an automation track that propels a automation track system for use with some embodiments ;
plurality of sample carriers having magnets in a base of each [ 0034 ] FIG . 16 is a cross sectional view of an exemplary
sample carrier using coils in a surface of the automation automation track system for use with some embodiments ;
track . Steps further include positioning , via the automation [ 0035 ] FIG . 17 is a top down view of an exemplary
track , a first carrier of the plurality of carriers at a first automation track system for use with some embodiments ;
location on the automation track that is accessible to aa robot [ 0036 ] FIG . 18 is a top down view of an exemplary
arm of the sample handler module , removing a first sample automation track system and logical subparts for use with
from the plurality of trays using the robot arm , and placing some embodiments ;
the first sample in the first carrier. Steps further include [ 0037] FIG . 19 is a top down view of an exemplary
positioning , via the automation track , the first carrier at a automation track system and logical subparts for use with
second location accessible to a pipette controlled by a first some embodiments ;
analyzer module of a set of one or more analyzer modules [ 0038 ] FIG . 20 is a top down view of an exemplary
and aspirating, using the pipette , a portion of the sample automation track section for use with some embodiments ;
while the sample is stopped , via the automation track , at the [ 0039 ] FIG . 21 is an electrical system diagram of an
second location. Additionally, steps include performing, by
the first analyzer module , a clinical analysis of at least one
exemplary automation track section for use with some
embodiments ;
of clinical chemistry characteristics and immunoassay char [0040] FIG . 22 is an electrical system diagram of an
acteristics of that patient sample. exemplary vessel mover system for use with some embodi
ments ;
BRIEF DESCRIPTION OF THE DRAWINGS [ 0041 ] FIG . 23 is a perspective view of an exemplary
[ 0016 ] FIG . 1 is a top down view of an exemplary sample patient sample tube carrier for use with some embodiments;
handling module for use with some embodiments ;
[ 0042 ] FIG . 24 is a side view of an exemplary patient
[ 0017] FIG . 2 is a perspective view of an exemplary sample tube carrier for use with some embodiments;
[ 0043 ] FIG . 25 is a top down view of an exemplary patient
sample handling module for use with some embodiments ; sample tube carrier for use with some embodiments;
[ 0018 ] FIG . 3 is aa series of diagrammatic top down states [ 0044 ] FIG . 26 is a top down view of an exemplary patient
of an exemplary carrier for use with some embodiments; sample tube carrier for use with some embodiments;
[ 0019 ] FIG . 4 is a diagrammatic view of an exemplary [ 0045 ] FIG . 27 is a top down view of an exemplary patient
integral, modular automation track system for use with some sample tube carrier for use with some embodiments ;
embodiments ; [ 0046 ] FIG . 28 is a system diagram for an exemplary
[ 0020 ] FIG . 5 is a diagrammatic view of an exemplary analyzer module for use with some embodiments ;
integral, modular automation track system for use with some [ 0047] FIG . 29 is a top down view of electromechanical
embodiments; systems for an exemplary analyzer module for use with
[ 0021 ] FIG . 6 is a diagrammatic view of an exemplary some embodiments;
integral, modular automation track system for use with some [ 0048 ] FIG . 30 is a perspective view of an exemplary
embodiments; reagent carrier for use with some embodiments; and
[ 0022 ] FIG . 7 is a diagrammatic view of an exemplary use [ 0049 ] FIG . 31 is a top down view of electromechanical
of a sample handling module for use with some embodi systems for an exemplary analyzer module for use with
ments; some embodiments.
[ 0023 ] FIG . 8 is a system diagram of an exemplary sample DETAILED SPECIFICATION
handler and vessel mover for use with some embodiments ;
[ 0024 ] FIG . 9 is a flow chart showing an exemplary Overview and System Architecture of Embodiments
interaction between the vessel mover and analyzer module ;
[ 0025 ] FIG . 10A is a perspective view of an exemplary [ 0050 ] An automation system for use with a clinical
cooling system for use with some embodiments ; analyzer, or an integrated clinical analyzer having an auto
US 2022/0308078 A1 Sep. 29, 2022
4
mation system , can include any of the following embodi which provides reliable and fast sample distribution system .
ments . Embodiments can utilize aa modular system including The vessel mover subsystem handles this material distribu
an automated clinical chemistry (CC ) analyzer module and tion . Under normal conditions, a lab technician never oper
an automated immunoassay ( IA) analyzer module, with ates the vessel mover track directly. The vessel mover
sample loading capability to transport patient samples to and manages carriers on an automation track that moves samples
from analyzer module (s ) where in vitro diagnostic assay or reagents, each carrier having a dedicated type of holders .
analyses are performed . The system can be scalable in For example, a tube holder has two locations ( sometimes
multiple configurations of the modules allowing customer called A and B ) and , under normal operation , only one of
yearly throughput needs ranging from low volume to very them has a sample tube (FIG . 3 ) . In some embodiments, a
high volume /mega market segments ( 500,000 to 5M + tests reagent carrier can handle reagents from both an immuno
per year ). assay ( IA ) module and clinical chemistry (CC ) module .
[ 0051 ] Some laboratories choose to link all of their various [ 0055 ] Utility Center - comprising subsystems that can
analyzers together using a laboratory automation system include : vessel mover failover power supply ; central com
(LAS ). The LAS ideally provides a place to centrally load puter system ; network switch for internal communication ;
and unload samples, and can automatically distribute those alternate track power supply; sample handler power supply.
samples for processing at each of the connected analyzers . [ 0056 ] Of these modules, the primary physical modules
Also included in the distribution path may be various types include the sample handler and vessel mover. The utility
of pre- and post - analytic devices , such as centrifuges, decap center includes primarily electronic subsystems in the cen
pers, recappers , and aliquotters. These devices can be acces tral computer system . The utility center is responsible for the
sible to the automation system , or may be standalone devices status of hardware components, maintaining operation of the
that require operators to manually remove sample tubes sample handler and vessel mover ( including power failover ),
from the automation system for pre- and post - processing . In and internal communications infrastructure .
some embodiments , the automation systems described [ 0057] In addition to individual analyzer modules, there
herein can also interface existing laboratory automation are three additional subsystems within these main modules
systems , allowing embodiments to expand upon existing that are worth additional noting in a summary of the system .
laboratory equipment or interface with modules that have [ 0058 ] Control Storage control and calibrator storage is
not been designed to interface with the automation systems a refrigerated module designed to cool quality control ( QC )
described herein . material while , at the same time , minimizing evaporation of
[ 0052 ] The automation system can be described as a QC material and light exposure . In some embodiments, the
process control manager ( PCM) that manages the processing control storage module is located in the sample handler, and
of samples. This includes providing input and output for may be referred to , generally, as refrigerated storage . When
samples into and out of the system , temporary storage of viewed from the front of the sample handler, the module is
samples while awaiting processing, scheduling of samples located behind the sample loading area and in front of the
for processing at various analyzers attached to the PCM , tube characterization station . Control storage can be
facilitation of the movement of samples throughout an accessed by the sample handler robot arm . In general, users
automation track (including onto and off of the automation do not have access to the control storage module directly
track ), and, in some embodiments, maintenance of the (except in the event of system failure , where the QC material
automation systems. An exemplary PCM for use with cannot be removed from module with the sample handler
embodiments
subsystems:
comprises the following main modules and robot ). The control storage module is generally designed to
store control and calibrator vials . Vials /tubes fit into a
[ 0053 ] Sample Handler (SH )—comprising subsystems thermally conductive tube base subassembly ( e.g. , a ther
that can include : control storage; robot ; gripper; module mally conductive plate having recesses to receive tubes ),
manager PC ; sample input /output (I /O ) ; drawer vision sys which is cooled using thermoelectric devices attached to the
tem (DVS ) . The SH acts as a sample source / sink . The SH is refrigerated storage subassembly. A control access door
the primary one of three ways the PCM system potentially assembly allows the sample handler robot to access QC
acquires samples. The other two methods are the Lab materials . The cover can further insulate the module and
Automation System ( LAS ) and the direct connect (manual) provide a light barrier. To further prevent evaporation , the
method . The SH provides a means for the user to load and subassembly can have a set of movable evaporation covers
unload regular samples, STAT samples, and control/calibra that sit over each QC tube .
tor vials onto and off of the system . Within the SH , the robot [ 0059 ] In some embodiments, the control and calibrator
subsystem is responsible for moving these tubes between storage is located in the rear center of the sample handler
other subsystems and modules, including the sample I / O module . Control and calibrator tubes can be loaded in the
( drawer trays), control storage , and the vessel mover . sample drawers in the same manner as sample tubes. In
[ 0054 ] Vessel Mover ( VM ) comprising subsystems that general, the subsystem cannot be accessed from the front of
can include : sample pucks/carriers; vessel mover manager; the instrument. The system track and tube characterization
track structure; coil boards; track mounting; master boards; station border the system on the rear side , in proximity to an
andanalyzer
an high levelsystem
node controller
having an( sintegrated
). Some embodiments utilize,
modular platform
automation track . In some embodiments, the control and
calibrator storage takes up the width of a sample handler and
which allows sharing of materials among analytical mod sits on the main component deck . In some embodiments,
ules . Materials can include patient samples or reagents for two pins are located on the component deck that allow the
the same kind of analytical modules. An integrated system control storage to be secured via screws . Beneath this deck ,
embodiment may provide a streamlined sample flow from three thermoelectric devices (TEDs ) cool the subsystem . In
the customer's point of view. This can be accomplished some embodiments, the area under the control storage is
through a single location for sample loading and unloading, subject to condensation that could build on the outside of the
US 2022/0308078 A1 Sep. 29, 2022
5
module or from condensation channels that help remove [ 0063 ] The TCS can also feature classification or pattern
condensation from the inside of the module. Mitigations, matching, in order to ensure that a wide variety of sample
such as having no electronic devices and the addition of a vessels can be identified . In some embodiments , the TCS can
drip tray, can be used accordingly. In some embodiments , a classify each tube as a certain type of standard tube. In some
drip tray located several inches below the TEDs collects embodiments, physical measurements can be optically taken
condensate from the inside of the module and allows air to identify the exact physical size of tubes to account for
exhausting from the TEDs to blow over any condensate and dimensions that are outside of nominal for each tube type .
assistant in evaporating it . Exemplary characteristics that can be conveyed include
[ 0060 ] DVS — The drawer vision system (DVS ) is a modu height, cap presence , orientation relative to vertical, asym
lar subsystem that may include , in some embodiments, a metry, etc.
fully independent set of electronics for each drawer. The Sample Handling System and Vessel Mover
DVS uses a global shutter and extremely short exposure Systems
time ( e.g. , a strobe of approximately 100 us ) to capture
images of the tube trays as an operator closes each drawer. [ 0064 ] The sample handler module is responsible for the
A drawer encoder system is used to trigger the cameras at main interface to the operator / lab technician . The sample
precise locations corresponding to each row in the tray (and handler module accepts sample tubes through the sample
in some embodiments , additional images at the front and input/ output (I /O ) area. The sample I /O area can include a
back of each tray to provide oblique camera angles for each passive drawer system capable of storing between 360 and
row ) . Because each row of tubes will appear in multiple 440 sample tubes , depending on sample tray configuration.
images of adjacent rows, the DVS can perform stereoscopic For example , an exemplary system accepts both 15 position
( or triscopic ) image analysis of objects in the tray. Each and 55 position sample trays, which can be placed in one of
adjacent image provides a different angular viewpoint and four slots . During the insertion of aa drawer by the operator,
perspective of each row of tubes. Additional explanation of the drawer vision system ( DVS ) will acquire images of all
some of the concepts of the DVS can be understood with of the rows in the trays. ( An exemplary DVS that may be
respect to Patent Application No. PCT /US2015 /035092 used with some embodiments is explained in further detail
incorporated herein by reference in its entirety. in Patent Applications PCT /US2014 /027217 and PCT/
[ 0061 ] In some embodiments, DVS cameras for each US2015 /035092 , incorporated herein by reference in their
drawer can be integrated into a custom image capture board , entirety .) These images from the DVS are transferred to the
which is responsible for synchronizing the image captured sample handler's module management processor, where
with the drawer motion . A buffer of the resulting images in they are analyzed , in parallel, with the robot's operation to
local memory can be created ( and overwritten if the drawer provide information on where tubes are located , determine
is not smoothly closed) and transferred to an external if they have caps or tube top sample cups , identify the size
computer for off -line analysis. This allows analysis to occur of each sample tube , and update information on the center of
at a much slower rate than the rapid rate in which the drawer the tube to improve pick /place accuracy and precision.
is closed by a human operator. Due to the brief exposure [ 0065 ] An exemplary sample handler comprises a three
time , in some embodiments , the DVS utilizes custom illu axis linear gantry robot based upon a linear servo motor
mination boards to reduce short pulses of high intensity light technology, which is responsible for the transport of patient
( e.g. , an illumination board can be mounted directly to the samples, quality control material, reagent calibrator mate
image capture board and provide a ring of LEDs around each rial, and, in some embodiments, reagent cartridges . The
camera lens to minimize shadows ). These two boards, along sample handler robot contains a stepper -motor -based linear
with a clear protective sheet of acrylic or glass that is actuator, which is used in a servo motor fashion , to apply a
mounted to the elimination board , form aa DVS optical stack . constant force to sample tubes in order to extract them from
[ 0062 ] TCS — a tube characterization station ( TCS ) is an 55 or 15 position sample trays in the drawer space , and to
integrated subsystem that uses a plurality of cameras (pref move them to the sample puck /carrier ( the terms being
erably three cameras ) to provide 360º imaging of objects on interchangeable as used herein , as the term puck is a
the vessel mover track . Namely, the TCS may be used to traditional term of carrier ) located on the vessel mover .
characterize sample tubes that are placed into carriers (e.g. , Human operators directly load and unload samples into the
by the SH robot arm ). The optical characterization informa 55 or 15 position trays, and then place them into manual
tion generated by the TCS can be used by central planner drawers that are accessible to the robot .
software ( operating at the central computer for the analyzer [ 0066 ] Once a sample is loaded into a sample carrier on
system) to identify each vessel , establishing chain of cus the vessel mover , it is presented to the tube characterization
tody, and to determine the processing tasks that are required station ( TCS ) for a set of images to be acquired, allowing a
for each sample , and thereby each sample carrier. For number of characteristics to be determined . This will allow
example , optical analysis of the sample tube can reveal the for the ability to read barcode labels in any orientation and
barcode information for each sample tube , which uniquely provide for a three dimensional perspective on the sample
identifies the sample tube contents. Tube characteristics can tube for acquisition of its key characteristics ( height, width ,
also be made available to pre - analytic and analyzer modules cap presence , cup presence , tube lean , tube center). Once the
to improve the efficiency and reliability. For example, any barcode is acquired and all relevant physical characteristics
deviations from the nominal orientation location of the tube are determined, the sample puck will be routed to the
with respect to a carrier can be conveyed to optimize appropriate analyzer, based on a decision from a central
pipetting from the sample tube . Furthermore, statistical planning processor and software , where it will be handed off
analysis of the behavior of sample tubes and carriers relative to the analyzer once it enters the proper in -process queue.
to nominal can be used to assist in calibration procedures of Once completed, the sample will return to the control of the
both the vessel mover and sample handler modules . vessel mover and be routed either to the next analyzer to be
US 2022/0308078 A1 Sep. 29, 2022
6
processed or the sample handler if all work is complete. As C. gradient in sample tubes stored within it ( gradient applied
long as there are unprocessed samples or any orders for only to tubes stored long enough to reach steady state ). Any
repeat processing ( either reflex , rerun , or auto - dilution) tubes identified for long term storage will be placed into this
available on the system , this cycle will repeat. module once the information is received from the tube
[ 0067] The TCS is comprised of three barcode readers and characterization station (TCS ) .
one image analysis camera, which acquire a set of images [ 0072 ] The refrigerated control storage module is a sub
upon external trigger to determine the following information assembly contained within the sample handler space whose
about each sample tube and carrier: sample carrier ID ( 2D primary function is to provide a refrigerated space for up to
barcode ); sample ID ( ID barcode ); sample tube height 60 sample tubes containing either quality control material
(mm ); sample tube width (mm ); sample cap presence ( True/ (QC ) or calibrator material. These sample tubes will be
False ) ; sample cup presence ( True /False ); sample tube cen stored in this compartment once identified by the TCS for up
terline relative to theoretical center (mm ). In some embodi to 7 days or the length specified by their instructions for use
ments, the TCS acquires an image of the tube in the carrier (IFU) , whichever is shorter.
from three cameras . [ 0073 ] FIG . 1 shows a top down view of an exemplary
[ 0068 ] With this information, the sample tube is then sample handler 10 that may be used for some embodiments .
transferred successfully to the vessel mover for distribution Within this figure, sample handler 10 is oriented so that the
to the required analyzers. An exemplary vessel mover is a front (i.e. , the face that the operator interacts with ) is at the
linear synchronous motor based conveyor system whose bottom of the page , while the back of the automation track
primary responsibility is the transportation of samples is located at the top of the page . Sample handler 10 includes
requiring aspiration ( either patient, QC , or calibrator) to the a tube characterization station 12 at the robot / track interface .
analyzer it is instructed to by a software planning compo Tube characterization station 12 characterizes tubes and
nent. Upon completion of all work orders for a sample the carriers when tubes are placed on carriers on track 14. This
carrier is returned to the sample handler where the robot allows information to be ascertained about the identity of the
moves the sample tube from the carrier back to either a tray tube placed in each carrier, and the physical condition of
or the refrigerated control storage compartment (depending each tube (e.g. , size of the tube, fluid level , whether there is
on the sample type ). a tube top cup, etc.) Adjacent to the tube characterization
[ 0069 ] The sample handler drawer system contains a mod station 12 sits a control / calibrator storage region 14. This
ule known as the drawer vision system (DVS ) . This sub allows long- term refrigerated storage of control and calibra
system is active when an operator closes a sample drawer tor fluids near the track , allowing these fluids to be easily
where it acquires images for each row of all of the trays placed into carriers on the track for movement to relevant
loaded into the sample handler. These images are then locations in the analyzer. The location of storage 16 also
transferred from the DVS to the sample handler module allows input/output drawers 18 to be placed in the front of
manager PC where they are processed to provide the fol sample handler 10. In this example, there are four adjacent
lowing information : sample tube presence ( True/ False ); drawers 18 that can be individually opened and pulled out.
sample tube cap presence ( True / False ); sample cup presence [ 0074 ] A robot arm 20 can move in two dimensions to pick
( True / False ); sample tube height (mm ); and sample tube up any of the tubes in drawers 18 and move those tubes to
offset from center (mm ). and from storage 16 and carriers on track 14. Robot arm 20
[ 0070 ] Based on the information output from the DVS , the can be positioned by moving a gantry from the front to the
sample handler robot sample tube coordinates will be back of aa sample handler 10 while a carriage moves side to
updated to minimize the potential for a jam condition during side along that gantry. Opposable end effectors can then be
the pick operation of a sample tube. Once the drawer is fully moved vertically to reach down to pick up tubes, closing the
inserted and the sample handling robot has the information end effectors when they are properly positioned to engage
decoded from the DVS acquired images , the robot will begin the tube.
the processing of the samples from the drawer to the sample [ 0075 ] To assist the robot arm 20 in successfully engaging
pick - place position, where it will place the sample into the each tube, a drawer vision system 22 is placed above the
open slot on a sample carrier. The robot will then move drawers at the opening to the drawers . This allows aa series
either to the left or the right, and retrieve a returning sample of images to be taken , looking down at the tubes in the trays ,
( in steady state operation ) to be put back into a sample tray as the trays are moved past the drawer vision system . By
for output to the operator. strobing a series of cameras, multiple images can be cap
[ 0071 ] In some embodiments, within the sample handler tured in a buffer, where each tube appears in multiple
space there exists a refrigerated space for the prolonged images . These images can then be analyzed to determine the
storage of quality control (QC ) and calibrator material for physical characteristics of each tube . For example, diameters
use in the system . QC and calibrator material can be used to and heights of each tube can be determined . Similarly, the
intermittently calibrate and verify quality control of certain capped or uncapped states of each sample can be quickly
instruments within the clinical analyzer. This material typi determined . Furthermore, the presence or absence of a tube
cally must be refrigerated to a uniform temperature to verify top cup (a small plastic well that is placed on top of a tube
effectiveness of calibration . Because calibration is done to allow a tube to transport a much smaller volume with
intermittently in the system , it is helpful to store QC and greater depth of the sample, to allow aspiration to more
calibrator material in a refrigerated compartment accessible easily take place ) can be ascertained . Similarly, the charac
to a sample handling robot. QC and calibrator material can teristics of any cap can be ascertained by the images . This
be stored in individual sample tubes containing material , can include certain color markings on the cap to identify a
allowing these tubes to be transported via the same vessel given sample as a higher priority (STAT) sample.
mover mechanisms as patient samples. The control storage [ 0076 ] The module manager PC can utilize this informa
module maintains a 4 ° C. to 8 ° C. environment with a < 4 ° tion to schedule samples to be moved from each tray in
US 2022/0308078 A1 Sep. 29, 2022
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drawers 18 into carriers on track 14. The module manager sible to track 14 ( and any track sections connected thereto ),
PC can also instruct robot arm 20 how to interact with each allowing an operator to deliver sample reagents to one
tube, including identifying the proper height for the end location for automatic delivery to refill reagents in the
effectors before engagement, and the proper force or dis analyzers, greatly reducing manual overhead in aa laboratory .
tance to use when engaging the end effectors to accommo [ 0082 ] FIG . 3 illustrates how robot arm 20 interacts with
date multiple diameters of tubes. sample tubes in carriers on track 14. In some embodiments,
[ 0077] In some embodiments, where a sample is deter dual position carriers are utilized , allowing a place and pick
mined to be of a fluid type that requires refrigeration, or movement by the robot arm . To illustrate this interaction ,
where a scheduling algorithm determines that refrigeration FIG . 3 shows three states for carrier 26. Carrier 26 includes
is needed because of a delay in processing that sample, robot two slots : one slot that carries an existing sample tube that
arm 20 can move that sample from drawers 18 ( or from a has already been processed after being moved by the vessel
carrier on track 14 if already on the track) into temporary mover system and is now ready for removal from the track
storage in refrigerated storage 16. In some embodiments, and placement into trays or refrigerated storage by the
refrigerated storage 16 is only used for control and calibrator sample handler; and another slot that is initially empty when
storage. In some embodiments, a determination of whether the carrier arrives on track 14 at a location suitable for
or not to store samples in refrigerated storage 16 depends on interacting with robot arm 20. This initial state is shown in
the available space within storage 16 ( i.e. , the space not state 27 , where an existing tube resides in the rearmost slot
2
taken by controls and calibrators ), allowing space to be ( the slot to the left) and the foremost slot ( the slot to the
dynamically allocated to mixed - use , as appropriate . right) is empty, awaiting placement of a sample from the
[ 0078 ] In some embodiments, refrigerated storage 16 input region to begin processing that sample tube . Robot arm
includes a thermoelectrically controlled plate having an 20 picks up the next scheduled sample from a tray in the
array of recesses configured to receive sample tubes. For input /output region , and moves along the three axis gantry
example , this plate can be a block of aluminum or steel that to place the tube into position for insertion in the rightmost
has been machined to have a series of cylindrical recesses slot . At state 28 , the robot arm lowers and places the new
2
sized to hold sample tubes. This aluminum or steel block can sample tube into the rightmost slot for processing. In this
then be coupled to thermoelectric coolers ( TECs ) , such as state , both slots are occupied by an already -processed
Peltier devices, and thermocouples /thermal sensors to con sample and by a sample yet to be processed . To remove the
trol temperature of the aluminum plate and, thereby, control already - processed sample , the robot arm can stay stationary
the temperature of fluid stored in sample tubes held in that and the carrier can be moved half its length to the right, or
plate . Meanwhile , an insulated lid that can be opened by a the robot arm may be moved the short distance to the
motor is placed on top of the storage area . This allows leftmost sample. At state 29 , the robot arm removes the
2
sample tubes to be placed into the refrigerated plate and leftmost sample and begins transporting it to storage in the
removed from the refrigerated plate without restriction , but sample handler, such as placing that sample into a tray
the volume of refrigerated storage is generally insulated and designated for output. The rightmost to -be-processed sample
closed , much the way a refrigerator might be . In some remains, and the carrier can then be transported by the vessel
embodiments, the tubes in refrigerated storage 16 can be mover system to its destination . Meanwhile, as the already
protected against evaporation by placement of a loose - fitting processed sample fills an output tray, an operator can be
lid that can be placed and removed by robot arm 20 . alerted that a tray is ready for removal and the operator may
[ 0079 ] FIG . 2 is a perspective view of a sample handler 10 . remove that tray.
In this example, track 14 is roughly parallel with the front [ 0083 ] By utilizing a place and pick carrier 26 , the overall
2
face of drawers 18 , while refrigerated storage 16 is a large transit required for removing existing post-processed
physical object between drawers 18 and track 14. Mean samples and inserting new preprocessed samples can be
while , robot arm 20 is moved on supports , well above the greatly reduced (as will be explained with respect to FIG . 7) .
height of drawers 18 and refrigerated storage 16. Tube For example , if only a single slot existed in a carrier, robot
characterization station 12 and DVS 22 are not shown in arm 20 would need to move into position above track 14 and
FIG . 2 , to allow the internals of sample handler 10 to be the carrier to remove that post process sample . Robot arm 20
better understood . would then need to move back across the entire sample
[ 0080 ] In some embodiments, drawers may be designated handler to place that post process sample into a suitable tray.
for certain tasks in software. For example, the processor Then , robot arm 20 would need to move into position over
controlling sample handler 10 can be configured to identify one of the input trays to remove the next preprocessed
any of the four drawers as sample input, sample output, or sample for analysis . Robot arm 20 would then lift that
sample input / output. By designating certain drawers as sample tube, move back across the entirety of the sample
dedicated to input or output, samples may be loaded in one handler to track 14 and the slot of the carrier, lower, and
location to start a batch, and removed from another location deposit that preprocessed sample into slot of the carrier.
when the samples are complete . Once an output tray is Meanwhile, the carrier sits idle on the track . By utilizing a
removed after being full, software can then designate the two - position carrier, the throughput of the robot arm can
respective drawer as an input lane , allowing an operator to effectively be doubled, and the amount of time that aa carrier
replace a withdrawn tray with a fresh tray of additional sits idle on track 14 can be greatly reduced . For example,
samples to test . where the transit time between any waiting position and the
[ 0081 ] In some embodiments, drawers may also be con position for interacting with the robot arm is on the same
figured to accept reagents in reagent vessels . Software can order as the time it takes for the robot arm to move to a tray,
identify which drawer, or portions of aa drawer, are desig deposit a post -process sample , pick up a preprocessed
nated for receiving fresh reagents . This can facilitate the sample, and move back to position above track 14 , the idle
automatic delivery of reagents to analyzer modules acces time for a carrier on track 14 can become de minimis . It
US 2022/0308078 A1 Sep. 29, 2022
8
should be noted that, the next time that carrier returns, the bolting their respective track segments together to form a
opposite order of occupied slots will occur, with the carrier long chain . In some embodiments, where there is an offset
arriving for place and pick interaction with a tube in the between the back track segment of the sample handler
rightmost slot. modules and the analyzer modules, as is illustrated in system
[ 0084 ] FIG . 4 illustrates the vessel mover components of 30 , an S - shaped bend may be needed to allow carriers to
the PCM that moves samples from an input region to move from the back track section of analyzer modules to the
analyzer modules, assists in handling those samples within back track section of the sample handler modules. In this
the analyzer, and returns process samples to the output example , this S -shaped bend is provided by bolting on track
region of the sample handler. Multi module analyzer system section 42 and the altered track segment in area 44. Thus, it
30 includes multiple interconnected modules. In this should be understood that the track segments within ana
example , system 30 includes multiple sample handlers 10 . lyzer modules, while integral to those modules, can be
By utilizing multiple sample handlers, more sample trays extensively modified at the time of installation , allowing
can be placed into the system , allowing a larger batch to be multiple configurations of the track segments within an
started at the beginning of the shift. Furthermore, this allows analyzer module . However, it should be understood that
twice as many samples to be placed onto , and taken off of, these track segments are still very much integral to those
the track . This means that, for larger systems with multiple analyzer modules . In some embodiments , the back of ana
analyzer modules that can operate in parallel, input / output lyzer modules 32 and 34 are flush with the backs of sample
throughput can match the analysis throughput of the parallel handlers 10 , eliminating the need for altering track segment
analyzers. For example, if an analyzer module can handle 44 and section 42 , entirely.
500 samples per hour, and three analyzer modules are used , [ 0089 ] Track segments 38 and 40 are U -shaped track
the input/output demand for feeding these modules may be segments that provide returns between front track segments
up to 1500 samples per hour. In some embodiments, a single and back track segments, allowing traffic to move around the
sample handler may not be able to handle this demand, track 14 without traversing interior chord segments within
necessitating adding multiple sample handlers to keep up sample handler or analyzer modules . This allows the track
with the input/output demand of the analyzer modules . 14 to form an outer loop , with main traffic moving along the
[ 0085 ] Furthermore, in some embodiments, one of the perimeter of the analyzer modules. Meanwhile, the internal
sample handlers can be set up to be used as an input, while track sections bypass the main loop , providing a direct path
the other sample handler can be set up as an output. By using between two sides of each analyzer module ( front to back ),
a modular approach , a single sample handler 10 can be used which serves as a route for local traffic . These chord seg
but , for larger systems , two or more sample handlers can be ments can also be referred to as internal segments / track
used . sections , bypass segments /track sections , or, in some cases ,
[ 0086 ] In an exemplary system 30 , two analyzer modules local track sections . These chord segments bypass the outer
are utilized . Analyzer module 32 is an immunoassay ana loop to provide access to a pipette. This allows small
lyzer. Analyzer module 34 is aa clinical chemistry analyzer. physical queues relevant to each sample handler or analyzer
These two analyzer modules perform different assays, test module to utilize those interior chord segments, without
ing for different characteristics of patient samples . blocking the overall flow of track 14 .
[ 0087] Track 14 is a multi-branching track that forms the [ 0090 ] A specialized track segment module 36 facilitates
heart of the vessel mover system . As can be seen , track 14 sample return and branching within track 14 to allow the
comprises branches and lengths that are provided integral to central computer system of the PCM to direct traffic in
sample handlers 10 and analyzer modules of 32 and 34. The flexible ways . The outside track portions provide a way for
functions of the individual branches will be explained with samples to move from sample handler modules 10 to track
respect to FIGS . 5 and 6. In addition to the track segments segments of analyzer module 32 , and vice versa . Mean
provided by these modules , additional modules 38 , 40 , and while , the inner chord of track segment module 36 provides
42 provide short dedicated track sections that may be bolted a branch whereby samples can move from analyzer 32 to
to the track portions provided by the other modules. Track analyzer 34 (in a counterclockwise manner ), without mov
modules 36 , 38 , 40 , and 42 provide powered track segments, ing into sample handler modules 10. This facilitates multiple
without additional hardware related to sample handler mod tests on a single sample tube , allowing sample tubes to freely
ules or analyzer modules . Whereas modules 10 , 32 , and 34 move between analyzer modules, regardless of how they are
may be full cabinets extending from a laboratory floor to the arranged on the right -hand side of system 30. This gives the
height of track 14 , and above , track segment modules 36 , 38 , PCM scheduling software flexibility in how samples order
40 , and 42 may be bolt - on segments that extend from the the tests within analyzer modules , without increasing traffic
cabinets of the other modules , without requiring floor- length on the track segments relating to sample handling. Track
support. Each of the modules in FIG . 4 can be bolted segment 36 provides a boundary between sources and sinks
together in modular fashion , utilizing leveling hardware , (e.g. , sample handler modules 10 ) and processors ( e.g. ,
such that each track segment between adjacent modules analyzer modules 32 and 34 ) by providing a branching loop
forms a virtually seamless track for carriers to traverse the within section 36 ( and section 42 , in some embodiments ).
vessel mover system . This loop allows sample carriers to move between the
[ 0088 ] In exemplary system 30 , it can be seen that section sources , sinks, and processors, including allowing samples
44 of the track of analyzer module 32 may need to be altered to loop without returning to the sources and sinks .
from the corresponding section of analyzer module 34. In [ 0091 ] Not shown in FIG . 4 is the central computer that
some embodiments, the track segments of analyzer modules includes a system instrument manager software component.
are in the same configuration as that shown in analyzer The instrument manager software consolidates information
module 34 when they are shipped from the factory. This from lower - level modules, such as sample handler 10 and
allows multiple analyzers to be placed in series, simply analyzer modules 32 and 34 , to present this information to
US 2022/0308078 A1 Sep. 29, 2022
9
an operator. The instrument manager receives information interact with sample handling robots in the sample handler
from the other modules via a network within the system modules. Carriers in queues 48 and 49 may have low priority
( e.g. , an internal Ethernet network ). Information may be samples that have completed , waiting for a free cycle of the
requested and provided asynchronously between the mod sample handler robot arm to offload the sample contained in
ules and central computer. The central computer can also each carrier. This frees the outer loop of track 14 to handle
work between the LIS and vessel mover systems to schedule higher priority samples, without requiring the flushing of
samples and their movement within the system . The central queues 48 and 49. Furthermore, where the system has
computer can also work between the vessel mover systems completed analysis of most or all pending samples and is
and individual modules to handoff control of the samples awaiting additional sample trays to be inserted, carriers that
and to initiate testing of samples once they arrive at a are not actively transporting samples for testing can be
location . stored in queues 48 and 49 , allowing those carriers to sit idle
[ 0092 ] FIGS . 5 and 6 show additional detail during normal without creating traffic on other segments of track 14 .
operation of the system shown in FIG . 4. FIG . 5 shows the Exemplary embodiments of a TCS are described in the
sample handler portion of system 30 , while FIG . 6 shows the following co -assigned applications , which are incorporated
analyzer module portion of system 30. In exemplary system by reference in their entirety: PCT /US2014 /021572 ; PCT/
30 , motion within the vessel mover system is generally done US2016 /018062 ; PCT/ US2017 / 014777 ; PCT/US2017 /
in a counterclockwise fashion, as shown by the arrows in 014778 ; PCT/US2017/ 014767 ; PCT/US2017 /014772; PCT/
FIGS . 5 and 6. Exemplary carriers ( shown as squares ) US2017 /014773 ; PCT/US2017 / 014774 ; and PCT /US2017 /
traverse the various track segments. It should be appreciated 014775 .
that the track segments in FIGS . 4-6 are shown in symbolic [ 0095 ] In some embodiments, an output queue 50 for
form for clarity. Further detail about the construction of sample handler modules 10 can be utilized to temporarily
these track segments is explained with respect to FIGS . hold sample carriers that are ready for analysis . Such a
14-16 . In most embodiments, track segments include a flat queue can be used when the system deems there are too
surface that supports the carriers , as well as vertical walls , many sample carriers already in the analyzer portion of the
and guide rails that assist carriers in moving in the proper track . Samples can then be gated in queue 50 until space
linear direction along the track surface . In some embodi within analyzers 32 and 34 frees up .
ments, carrier 46 in track segment module 40 can use the [ 0096 ] Meanwhile, samples 51 within track segment mod
track segment module 40 to bypass queues for individual ule 36 can utilize module 36 to bypass the sample handler
sample handling modules ( such as when carrying a STAT section of the automation track to return for further testing
sample ). In some embodiments, track segment module 40 within the analyzers.
may also be accessible to an operator, allowing carriers with [ 0097] As shown in FIG . 6 , sample carriers within the
samples requiring manual interaction (e.g. , samples that analyzer section can utilize the track geometry to efficiently
have resulted in an error at some point in the system) to be interact with analyzer modules 32 and 34. Analyzer 32 has
presented to an operator for removal or inspection . This a pipetting station in proximity to carrier 52. When a sample
allows track segment module 40 to act as a maintenance port is moved into the position of carrier 52 , a pipette for IA
for an operator. In some embodiments, track section module analyzer module 32 can aspirate a sample portion for testing .
40 can also provide access to a laboratory automation Meanwhile, the internal track segment of module 32 can act
system (LAS). as a physical queue 53. These internal track sections for
[ 0093 ] Some laboratories choose to link various analyzer analyzers can be bidirectional . Thus , physical queue 53 can
systems together using an LAS system . The LAS provides a be moved towards the front or the back of analyzer module
place to centrally load and unload samples and, in this 32. This allows queue 53 to act as an independent random
example, allows samples handled by sample handlers 10 to access queue by moving an appropriate carrier to the
have access to external automation systems that allow those pipetting location without flushing the entire queue around
samples to be handled by legacy systems. For example, the track (e.g. , samples can be moved to the back of position
older analyzer modules may not be accessible to the track 52 if a sample in the middle of the queue needs to be
system of many embodiments. For example, a whole blood accessed) . In some embodiments, a local processor within
analysis module may already exist in a laboratory that is not each analyzer module handles the queuing within the physi
directly connected to the track segments discussed herein . cal queue in the inner track segments of each analyzer
By connecting a robot arm (which may be provided by the module . For example, a processor within analyzer module
to track segment module 40 , samples can be removed 32 can control the track segment for queue 53 to access any
from section 40 and placed into existing automation systems carrier within that queue on demand . Meanwhile , the global
that exist in the laboratory. Those samples can then be processor that manages traffic on track 14 for the entire PCM
moved to the whole blood analyzer module that is connected system can be responsible for adding sample carriers to each
to the LAS . In such an embodiment, track section 40 is a local queue and removing carriers therefrom . Thus, from the
source or sink for patient sample tubes . vessel mover global processor standpoint, each queue within
[ 0094 ] Carrier 47 is stopped at the interaction point for the an analyzer is a first in first out ( FIFO ) queue , while the local
robot arm in sample handling module 10. Carrier 47 can track manager within each analyzer module queue can be
pause for a place and pick interaction with the sample random access.
handler robot arm , and then be characterized with the new [ 0098 ] Like queue 53 , queue 54 in analyzer module 32
2
sample tube by the TCS for sample handler module 10. In allows random access for the CC analyzer module 34 to the
some embodiments, a single TCS can be installed in the local bidirectional track to any sample contained therein .
rightmost sample handler 10 to reduce the overall cost of Sample carrier 56 is placed at an interaction point for the
installing multiple TCS systems. Meanwhile, small physical local pipette for analyzer module 34. Sample carrier 58 is
queues 48 and 49 contain sample carriers that are waiting to arriving to join queue 54 from the outer track segment. At
US 2022/0308078 A1 Sep. 29, 2022
10
this point, control over detailed management of the location time can vary. FIG . 7 shows the exemplary movement that
of sample carrier 58 can be handed off from the global vessel occurs within a single movement.
mover manager processor to the local processor within [ 0103 ] FIG . 7 shows an exemplary path for the robot arm
analyzer module 34 that controls the internal track segment. 20 during a place and pick movement. At position A , the
Similarly, sample carrier 60 has completed its interaction robot arm descends to retrieve a sample to be processed from
with analyzer module 34 (e.g. , analyzer module 34 has drawer 1. The robot arm then moves over track 14 to
completed aspirations from the sample tube being carried ), position B to deposit the tube into an awaiting carrier. If the
and the local track returns carrier 60 to the main loop of track awaiting carrier has a post-processed sample ready for return
14. Sample 62 is on return track segment module 38. This to drawer 3 , robot arm 20 moves to position C. At position
track segment can be used for samples that are bypassing C , robot arm 20 descends and picks up the awaiting sample
local analyzer track segments . For example, if the track tube that is finished. The robot arm then moves to position
needs to be flushed for some reason , or if local queues are D , where an open slot exists in drawer 3. Robot arm 20 then
full, this path can be used to place sample carriers in deposits the sample in that awaiting slot , completing the
effectively a holding pattern . motion . Then , robot arm 20 will move to the next position
[ 0099 ] In some embodiments , carriers can carry more than in drawer 1 for the next sample to be processed. The entire
just patient sample tubes. Carrier 64 is a carrier configured circuit completed by the robot arms should take no longer
to traverse the track 14 and carry reagents to analyzers, than the overall cycle time for the sample carrier. For
rather than patient sample tubes . In some embodiments, an example , in some embodiments, the cycle time may be 7.2
interface between analyzer module 34 and carriers holding seconds , allowing 500 samples per hour to be processed by
reagents can exist at the location of carrier 64. At that each sample handler .
location , in some modules, a robot arm or other appropriate [ 0104 ] The DVS and control storage compartment operate
movements system can capture a reagent vessel ( such as a concurrently within the robot cycle time and are, therefore,
reagent wedge ) , removing that reagent from the carrier, and not observable to other modules. The DVS transfers images
placing that reagent wedge into a local reagent storage to the sample handler module manager PC when requested,
within the analyzer. For example , immunoassay analyzer where the images can be decoded at approximately 150
module 34 may require certain reagents that are not gener milliseconds per image , in some embodiment. The control
ally stored within the analyzer, or may need to refill reagents. storage compartment has 1.00 second allotted for opening
In some embodiments, an operator can insert appropriate and closing the doors. The remainder of the activity required
reagents into the sample handling module for automated to move a tube in or out of the compartment does not fall into
delivery of reagents to appropriate analyzer modules . Exem the 7.20 cycle boundary.
plary logic and systems for delivering reagents to local [ 0105 ] FIG . 8 is a system diagram of the interaction
analyzer modules via the automation track can be under between a sample handler 10 and vessel mover 68. Vessel
stood with respect to co - assigned U.S. Pat. No. 9,645,159 mover 68 represents the system that manages the movement
and patent application PCT/US2014/ 011007 , incorporated of hardware within the tracks to move sample carriers
herein by their entirety . between and amongst analyzers and sample handlers. Vessel
[ 0100 ] In some embodiments, tubes containing controls mover 68 is controlled by vessel mover manager 70. Vessel
and calibrators that are taken from refrigerated storage 16 mover manager 70 is responsible for interacting with the
can be placed into carriers that stop at the location of carrier central computing system for the analyzer system to com
64 , allowing analyzer modules to sample controls and cali municate the presence of samples on an automation track
brators in aa different location on the track than that of patient and receive information about proper destinations and
samples . In other embodiments , controls and calibrators are scheduling for those samples. Sample carriers 47 and TCS
placed into queues 53 and 54 for interaction with analyzer 12 are also part of the vessel mover, along with automation
modules in a manner similar to that of patient samples. track sections . When a sample carrier 47 arrives at the proper
[ 0101 ] In some embodiments, the sample handler and the
location in proximity to a sample handler 10 , robot 20
interacts with a sample carrier 47 to remove finished sample
vessel mover are asynchronous devices , which must coor tubes and add new sample tubes to sample carrier 47 for
dinate their interaction at a single position . The vessel processing.
mover , as such, does not have any defined cycle time ; it is [ 0106 ] Sample carrier 47 moves into position with TCS
a purely event driven system that will respond to commands 12 , setting off a proximity trigger. This trigger can be a
to bring a carrier to the sample handler or move a carrier to wireless communication between carrier 47 , a physical
the exit queue once a TCS image has been acquired . In some switch on TCS 12 , an optical switch or electrical sensor on
embodiments, the TCS is also an asynchronous device that, TCS 12 , or any other suitable device for detecting the
when triggered, will release a carrier for movement 1.00 presence of sample carrier 47 at TCS 12. From its interaction
second after it is triggered . Analysis and reporting of the with sample carrier 47 , TCS 12 identifies the ID of the
results from the TCS will take place up to 1.00 s after the sample tube in the carrier (e.g. , by scanning the barcode with
completion of the image acquisition. This timing can fluc one of the cameras and TCS 12 ) and determines the physical
tuate based on the exact characteristics of the image characteristics of the tube and carrier. These characteristics
acquired and the algorithm processing the images but , are then assigned to sample carrier 47 by TCS 12. The
preferably, will not take any longer than some predetermined sample ID is then communicated to the central computing
time limit , such as 1.00 s . system for scheduling of that sample . Once the central
[ 0102 ] In some embodiments, the sample handler is computing system has a sample 80 , it can determine the
designed to operate on an overall cycle no longer than 7.20 appropriate test schedule based on information in the labo
seconds in duration . However, due to the difference in ratory information system ( LIS ) . Once the test schedule has
location of tubes within the sample I/ O area , the actual cycle been determined, the routing destination (and, in some
US 2022/0308078 A1 Sep. 29, 2022
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embodiments, schedule) for that sample and carrier can be information can be used by the vessel mover manager to
determined and computed by the central computer. instruct each local track section on how to handle sample
[ 0107] Once TCS 12 has finished characterizing the tube carrier 47 , including appropriate accelerations, speeds,
held by separate carrier 47 , the vessel mover manager can branches, etc. Vessel mover manager 70 can thereby act like
request destination information from the central computer . a traffic manager, instructing various switches and linear
Once it receives the destination , vessel mover manager 70 motors within the automation system to route sample carrier
can determine the appropriate path to send the sample carrier 47 appropriately.
47 , along with the immediate schedule for reaching that
2 [ 0111 ] Sample handler 10 has four main logical compo
destination based on the current traffic and routing informa nents for purposes of understanding the interaction with
tion for other sample carriers on the track . Vessel mover vessel mover 68. Trays 70 are inserted into drawers 18 to
manager 70 maintains a state model for each carrier on the load and unload patient sample tubes . When a tray 72 is
automation track , including destination information, path inserted into a drawer and the drawer is closed, an encoder
information , scheduling information where appropriate, etc. on the tray or drawer communicates the motion of tray 72 to
Vessel movement manager 70 then assigns a path to reach DVS 22. This allows the DVS 22 to snap one or more photos
the next destination to sample carrier 47. Vessel mover as each row of sample tubes is inserted into the drawer. This
manager 70 then facilitates movement of that carrier to the allows the DVS 22 to maintain a rewritable buffer of images
appropriate destination . Upon arrival at that destination , corresponding to each position in the drawer. This allows
vessel mover manager 70 sends confirmation to the central multiple angles of images of each tube in each row of tray
computing system that the sample has successfully arrived at 72. DVS 22 then utilizes this information to determine the
the destination . This allows a central computing system to physical characteristics of each tube in tray 72. For example,
determine the next appropriate step in handling that sample . DVS 22 can determine the presence of tube top cups,
[ 0108 ] In embodiments where analyzers maintain move diameters of each tube, heights of each tube location of each
ment and scheduling control over the internal path (e.g. , the tube in tray 72 , locations of empty slots in tray 72 , etc. In
chords that pass through each analyzer between the outer some embodiments , DVS 22 does not attempt to find and
track ), the central computing system may determine the next read barcodes on tubes in tray 72. In general, images taken
destination for that sample carrier, but the exact timing on by DVS 22 are taken from above each row of tray 72 ,
when that sample carrier will be released to vessel mover 68 allowing top -down views of each tube , as well as oblique
will be determined by each analyzer module. When a sample views of each tube as photos of adjacent rows are taken .
arrives in an analyzer module, vessel mover manager 70 can [ 0112 ] The DVS may be a modular subsystem , with a fully
hand off control of that sample carrier to the local analyzer independent set of electronics for each drawer, including an
module when the carrier is placed into the internal track image sensor to capture images of tube trays as an operator
section of the analyzer module . The analyzer module then quickly closes the drawer (e.g. , at speeds at below 1.0 m / s ).
manages its own physical queue , allowing it to determine Because the drawer may move in an unpredictable manner,
(based on information received from the central computer the DVS must activate the flash repeatedly over a short
system ) the appropriate schedule of testing and completion period of time . Triggering the flash at an extremely high rate
of each sample. Upon completion of testing in an analyzer of speed could account for this difficulty ; however, it would
module, the analyzer module will then move the sample require the use of a very expensive high - frame- rate camera
carrier back onto the outer track , via the internal track of the (i.e. , image capture device) , and computationally intensive
analyzer module, and transfer control back to vessel mover video processing techniques, in order to detect the flashes of
manager 70. Once vessel mover manager 70 receives control light at very high speeds ( e.g. , 60 Hz ) . Lower speeds ( e.g. ,
of the carrier again , it can then request the next destination 13 Hz) cannot be used , as they may cause migraine head
for that carrier from the central computer system . aches and even trigger epileptic seizures . Additional detail
[ 0109 ] As shown in FIG . 8 , sample carrier 47 is assigned about this exemplary feature can be found in simultaneously
characteristics by TCS 12 , and path information by vessel filed U.S. Provisional Patent Application No. 62 /365,295 ,
mover manager 70. In some embodiments , a sample carrier which is incorporated herein by reference in its entirety.
can include onboard addressable memory that can locally [ 0113 ] Accordingly , an embodiment provides a combina
store this information and use information to reach its tion of techniques that may be used to illuminate the target
destination . In such embodiments, the sample carrier 47 can for image capture. For example, one embodiment may shield
communicate this information to each track section proces particular lines of sight from the operator using covers . An
sor and to the local analyzer module . The analyzer module embodiment may also utilize one or more reflective surfaces
can use the characteristics to properly move the sample (e.g. , mirrors ) to shield the operator, while also still allowing
carrier into position relative to an aspirating pipette to an observational ability. A further embodiment may attempt
aspirate sample portions for testing. This information can to minimize the absolute brightness of the flashing light
also guide the pipette in interacting with a sample by (e.g. , reflective surfaces are covered or painted with a
understanding the height of the tube, width of the tube , non - reflective matte style finish ). Another embodiment
orientation of the tube, presence of tube top cups, etc. Path minimizes the perceived contrast of the flashing light to any
information can be used by processors controlling each local local ambient /background light. In one embodiment, the
track section to route sample carrier 47 appropriately. flashes may be synchronized to specific events that the
[ 0110 ] In other embodiments , the characteristics and path operator expects to cause optical disturbances.
assigned to sample carrier 47 are not directly communicated [ 0114 ] These characteristics are then communicated to
to sample carrier 47 but , rather, are communicated directly, robot 20 , allowing the robot to utilize these characteristics to
or via the central computing system , to the appropriate properly engage sample tubes when selecting the sample
processors of the system . For example, characteristics will tubes for placement into sample carrier 47. For example,
be communicated to the destination analyzer module . Path height and diameter characteristics can be used to adjust the
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descent height of robot end effectors, the degree to which the vessel mover power module 74 , while preventing downtime
end effectors close to engage the sample, and the location of due to soft failover of systems .
the center of the sample tube, without misalignment dam [ 0118 ] Similar to the way that vessel mover power module
aging the sample tube . Robot 20 interacts with tray 72 by 74 can fail and a local power controller can receive power
removing and placing sample tubes. Similarly, robot 20 from sample handler module 76 , vessel mover power mod
interacts with refrigerated control storage 16 by removing ules can also provide redundant failover power to adjacent
and placing quality control and calibration tubes. Similarly, track sections , should the adjacent vessel mover power
those tubes taken from , or placed into , control storage 16 modules fail. In this manner , as additional track sections are
tray 72 are placed into, and taken from , sample carrier 47 by added to a system , power controllers can daisy chain adja
robot 20 . cent power modules for redundant failover to prevent down
[0115] FIG . 8 also shows how redundant power may be time of track sections due to power module failure .
used to assist in a modular design of the vessel mover 68 . Vessel Mover System
Because the automation track is used to move samples
between sample handlers 10 and analyzer modules, it is [ 0119 ] The vessel mover subsystem has the responsibili
important that the automation track not fail during normal ties of receiving a sample or reagent from a source / sink ( e.g. ,
operation. Because the automation track is made up of track sample handler or LAS interface ) and presenting it to an
segments, the failure of a single track segment may cause the analytical module for processing. This generally includes
entire automation track to come to a standstill , crippling the the magnetic track for moving sample carriers, those sample
ability of analyzers to receive additional samples. Labora carriers, any reagent carriers (which , in some embodiments ,
tories deal with large volumes of patient samples, and can be sample carriers ), control systems for the track , and
minimizing downtime of an analyzer system is important. any interfaces between the track and sample handling mod
One way that failure of track segments can be overcome is ules or analyzer modules. The vessel mover is not com
by utilizing redundant power systems . This removes the monly accessed by an operator. The vessel mover also
power system of a track segment as a point of failure . As can presents the vessel back to the source / sink for removal from
be seen in the example in FIG . 8 , a vessel mover power the system . As used herein , sample handler 10 can be
module 74 provides power to the systems of the vessel described as a source /sink for samples, calibrators, and
mover 68. There can be a plurality of vessel mover power controls. In some embodiments, reagents may also be loaded
modules 74 that provide power to portions of track seg via a sample handler 10 , allowing that sample handler to act
ments, groups of track segments, or subsets thereof. In this as a reagent source / sink . The vessel mover contributes to
example, a single vessel mover power module 74 powers the overall system throughput by providing random access of
local track segment where the TCS 12 is located . To prevent the samples to the connected analytical modules .
vessel mover 68 from failing if vessel mover power system [ 0120 ] The following is a list of exemplary functionalities
74 fails, vessel mover 68 has the ability to receive power and responsibilities for the vessel mover system .
from adjacent sample handler power module 76 in the event [ 0121 ] Sample Vessel Movement
of such failure. Sample handler power module 76 provides [ 0122 ] handshake with a sample source/ sink to accept a
power to sample handler 10. Sample handler power module sample tube
76 can be sized appropriately to have enough overhead [ 0123 ] identify sample and tube characteristics
current available to power adjacent track sections , at least on [ 0124 ] store and make available current sample inven
a temporary basis , as needed . A power controller within the tory of vessel mover
vessel mover 68 can detect a power failure of the vessel [ 0125 ] execute routing instructions from planner
mover power module 74 , and automatically switch over to [ 0126 ] maintain sample pipetting queues for each ana
sample handler power module 76 as a power source . lytical module
[ 0116 ] This power controller can alert the central com [ 0127 ] handshake with analytical module to allow ran
puter system to identify the error to an operator. Because this dom access pipetting
does not automatically stop the automation system , the [ 0128 ] handshake with a sample source / sink to off - load
current batch of samples can be handled, and a maintenance a sample tube
time can be scheduled to resolve the failure of vessel mover [ 0129 ] Reagent Vessel Movement
power module 74. In addition, in some embodiments, power [ 0130 ] handshake with a reagent source / sink to accept a
module 74 is hot - swappable . For example , a laboratory may reagent pack
have spare power modules that can be swapped in place of [ 0131 ] handshake with an analytical module to off - load
power module 74 , should failure occur. In the meantime, a reagent pack
sample handler power module 76 can provide power [ 0132 ] handshake with an analytical module to accept a
between the failure and the completion of the hot swapping reagent pack
process. This can virtually eliminate downtime due to power [ 0133 ] handshake with a reagent source / sink to offload
system failure in the vessel mover 68. Meanwhile, sample a reagent pack
handler power module 76 can be built with more expensive , [ 0134 ] In some embodiments, reagents may be loaded
more robust components, while the vessel mover power automatically into analyzer modules via the track system of
module 74 can be constructed of cheaper, less robust com the vessel mover system . Reagent packs may be loaded into
ponents because of the ability to redundantly prevent failure . drawers in an alternate embodiment of a sample handler 10 .
[ 0117] Furthermore, because there are generally more For example, certain drawers would be designated as reagent
track segments, and because the overall vessel mover system drawers, while other drawers are designated sample drawers.
68 is expandable and customizable , it is anticipated that [ 0135 ] A sample source / sink is a subsystem that has the
there will be many vessel mover power modules 74 in the responsibility of receiving sample tubes from an outside
system . As a result, it may be feasible to reduce the cost of source ( e.g. , operator or LAS track ), and presenting them to
US 2022/0308078 A1 Sep. 29, 2022
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the vessel mover or vice versa . In addition to the sample system as a whole . In some embodiments, the vessel mover
handler 10 , in some embodiments, there can be other imple computer can be embedded in one of the track section
mentations of the sample source / sink to meet specific cus components, such as track section 36 in FIG . 4 .
tomer needs . Some of the variants can be (but are not limited [ 0148 ] The vessel mover software can receive input from
to ) subsystems with smaller or larger capacity, higher or carriers in sample handling robots to maintain a state model
lower throughputs, or extended workflow features. In gen of all interactions in the track system . For example , when a
eral, sources / sinks conform to the basic interfaces of a sample handling robot places a new sample in the carrier,
sample source / sink , such as sample handler 10. In general, that carrier or robot can notify the vessel mover software of
embodiments contain aa minimum of one sample source / sink the new association between the sample and carrier. The
to be considered complete. In some embodiments, up to vessel mover software can then notify, via the Ethernet
three sources / sinks can be attached to the vessel mover connection , the system instrument manager software in the
system . This allows parallel input and output capabilities , central computer. This allows the central computer for
increasing the throughput of the overall system . instrument 30 to maintain a state model of all samples in the
[ 0136 ] The following are exemplary functionalities and system , associating the samples with the current module that
responsibilities of a source / sink in the analyzer system . has control of the samples, as well as a schedule of tasks to
[ 0137 ] allow the operator to load samples onto the be performed on the samples. Once the barcode of a sample
analyzer system is read by the tube characterization station , additional state
[ 0138 ] allow the operator to unload samples from the information about the sample and carrier relationship can be
analyzer system communicated from the tube characterization station to the
[ 0139 ] select a sample to be moved to the vessel mover vessel mover software, allowing an updated state model .
[ 0140 ] handle requests for pre - identified samples to be This information can also be communicated to the central
moved to the vessel mover computer. The state model maintained by the vessel mover
[ 0141 ] move a sample to the vessel mover and by the central computer can be updated at each point
[ 0142 ] remove a sample from the vessel mover when along the process, as samples are moved from an analyzer
requested module, tested , moved to another analyzer module , tested ,
[ 0143 ] store and make available the current sample returned to a sample handling module, and removed from
inventory the system.
[ 0144 ] load samples from LAS into the analyzer system [ 0149 ] Each source / sink also interacts with the system
0145 ] unload samples to LAS from the analyzer system instrument manager software in the central computer of the
[ 0146 ] As shown in FIG . 4 , the vessel mover system analyzer system . Communicating over an Ethernet connec
includes a plurality of track sections that can be connected tion , each source / sink ( e.g. , sample handler) identifies when
to form a single track to transport samples ( and in some it has received sample trays and any identity information and
embodiments , reagents ) from a source / sink to various ana status information it may have , as samples are removed from
lyzer modules. In some embodiments, this track is made up the trays, placed into carriers on local track sections , and
of stainless steel channels that include guide rails in the returned . Furthermore, statistical information about the
walls and a flat floor. Carriers can include a low friction number of samples handled , the number of samples remain
material, such as ultra -high -molecular -weight (UHMW ) ing , etc., can also be maintained by the source / sink and
polyethylene, Teflon , or other suitable materials on the communicated to the system instrument manager. When a
bottom of each carrier. This bottom material allows the sample arrives at each source / sink , a processor for that
to glide along the flat track , guided by guide rails module can req est a unique identifier for each sample from
the walls . Underneath the metal surface of the track , a series the system instrument manager. Even before the barcode is
of magnetic coils form linear synchronous motors (LSMs ) . read , this unique identifier can be used to track that indi
Meanwhile , a plurality of rare earth magnets in each carrier vidual sample tube . Once that sample tube has had its
responds to changes in these coils , by moving the carrier barcode read by the tube characterization station , an asso
synchronously with changes in those coils . Exemplary ciation between the identity of the sample and a unique
embodiments utilize appropriately sized LSM coils on a identifier for that tube can be made by software in the system
plurality of boards that are produced by MagneMotion, Inc. instrument manager in the central computer.
The basic operation of these linear synchronous motors can [ 0150 ] Also residing within the central computer is a
be understood with respect to U.S. Pat . No. 8,967,051 , planning subsystem running in software . This planner is
assigned to MagneMotion , Inc. tasked with the primary role of utilizing information about
[ 0147] The vessel mover system includes both software the system and internal business roles to select individual
and hardware components. In addition to individual track analytical modules within the system , and identify those that
sections and local controllers for those track sections , hard will perform each test on each sample within the work order
ware for the vessel mover system also includes a computer for that sample . With this information , the planner will
that includes a processor having memory, peripheral circuits, instruct the vessel mover to move a sample to the sample
disk drives, network interfaces etc. The vessel mover com queue for that particular analytical module . When that
puter works with the instrument manager in the central analytical module is finished aspirating from the sample, the
computer for the overall analyzer instrument to schedule and vessel mover will then request the next destination for that
facilitate movement of samples. In some embodiments, sample upon being released by that analytical module . That
communication between the central computer and the vessel destination , coming from the planner of the central com
mover computer occurs over an internal Ethernet / IP back puter, can be another analytical module ( if more tests need
bone. Each module in system 30 is connected via an to be performed ), or a sample source / sink , which allows that
->
Ethernet connection, allowing a central computer to com sample to be removed from the vessel mover. In some
municate with each module, including the vessel mover embodiments , the vessel mover software and planner reside
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on different processors, and information is exchanged via the [ 0154 ] The planner module of the central controller also
network within the instrument. In some embodiments, the communicates with the sample source / sink modules. This
vessel mover software and planner operate on a single allows the planner module to understand when samples are
processor, allowing communication to take place via inter received , when they are moved onto a local carrier and
processor communication or memory . handed off to the vessel mover, received from the vessel
[ 0151 ] The work order for an individual sample is mover, and placed into an output slot or storage slot within
received by the central processor from an LIS . The LIS can the source / sink module . This allows a software association
maintain a database of all work orders for all samples that between each slot , and the identity of the sample makes it
are to be processed in a laboratory that day. The planner easier for performing additional subsequent tests on that
software component can associate those work orders sample because its storage location is known .
received from the LIS with individual samples at the begin [ 0155 ] As explained above, the vessel mover and sample
ning of a shift or on - demand . When the vessel mover source / sink modules interact with each other at a point
identifies the specific identity of the patient sample on the where aa local track section is accessible to the robot arm of
automation track , the vessel mover software communicates the source / sink (e.g. , track section 14 , where sample carrier
with the planner to identify a schedule of tasks and desti 47 is shown ). The vessel mover is responsible for moving a
nations for that sample. That sample's identity is compared carrier at a predetermined location accessible to the robot
arm , while the robot arm is responsible for successfully
to the work order, to identify the appropriate work order and
order of tasks to be performed on that sample. The planner interacting with the carrier placed in the right location . This
software module then reviews the status of each analytical ensures proper hand off of sample between the source / sink
module in the system to identify the appropriate analytical and the vessel mover modules.
module to receive that sample and perform each test of the [ 0156 ] In some embodiments , the vessel mover and ana
work order. Where multiple analytical modules can perform lytical modules interact with each other at two general
the same test , scheduling logic in the planner software can groups of points. The first set of points is where the
load -balance these analytical modules to ensure maximum individual sample tubes are presented by the vessel mover to
throughput ,while minimizing latency of individual queues the analytical module for interaction . In some embodiments ,
this location is synonymous with the location of carriers 52
for individual analyzer modules.
[ 0152 ] Once a schedule of destinations for these tests has and 56. In some embodiments, the vessel mover module
been calculated by the planner module, a basic path of the maintains low - level control of the individual track section
order of destinations can be sent to the vessel mover. The chords that serve as the queues for each analytical module .
vessel mover then operates under its local control to move The vessel mover operates these sections at the request of
each sample to each analyzer module, informing the planner each analytical module to act as a random - access queue. In
each time the sample reaches its destination . The planning this manner, each analytical module's processor only needs
module can then maintain a state model of each sample and to have a queue model for samples that it can access , while
for the system . In some embodiments, the vessel mover only the individual steps required to move each sample into
maintains a model of the next destination for each sample. position at the head of each queue , or at the access point for
Thus, once a sample is delivered to each analyzer module, each queue , are carried out by the controller for the vessel
the planner module is notified . Control of that sample is mover . This allows vessel mover software to have expertise
handed off to the local analyzer module. The local analyzer in moving samples using the magnetic track , while software
controls its local track section as a random -access queue . in the analytical modules can be specialized for testing , with
Once that local analyzer module has completed testing on a basic model of how samples are moved in a physical
the sample, that analyzer module can communicate the buffer .
change in status to the vessel mover or to the central [ 0157] In some embodiments, the second group of points
computer planner module. Control can be handed off to the where the vessel mover interacts with each analytical mod
vessel mover. The local analyzer then moves the sample out ule is at the location of a reagent carrier 64 in FIG . 6. In these
of the local track section onto a portion of the track section embodiments, a carrier can present reagent packs at a given
accessible to the vessel . The vessel mover then moves the location on the outer track , allowing the vessel mover to
sample carrier onto the outer track section when traffic bring reagents to each analytical module .
allows . The vessel mover then communicates with the [ 0158 ] Analytical modules and the vessel mover coordi
planner module to identify the next destination for that nate their activities for moving and accessing sample tubes
carrier. Upon rec ing that destination from the planner in such a way that the system provides random access for
module , the vessel mover then maintains low - level control each of the samples in a shared queue . By maintaining
of that carrier and directs the traffic , accordingly, until that random access , the analytical modules may utilize their own
carrier reaches that destination , upon which the central internal scheduling algorithms to maintain a higher nominal
planner module is notified and control is handed off to the throughput and , thus, improve the overall time efficiency.
appropriate local module . [ 0159 ] In some embodiments, each analytical module can
[ 0153 ] Once all tests are complete on a sample for the maintain a logical queue in software of all the samples for
local analytical modules, the planner module notifies the which that local analyzer module can access after some set
vessel mover to move that carrier to an output queue for the time . For example , in the example shown in FIG . 6 , IA
appropriate source / sink . The vessel mover receives the des analyzer module 32 can maintain a logical queue that
tination command and moves that sample carrier to the includes samples other than just samples 53. For example,
physical location of any queue for the source / sink ( e.g. , samples 60 , 62 , and 51 can be part of the random - access
sample handler 10 ) , and notifies the planner module to queue maintained in software in analyzer module 32. By
confirm that control is been handed off to the designated requesting each sample one cycle (or more) before it is
source /sink . needed , the vessel mover can supply any sample that it can
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access in a just - in - time manner, such that samples in a mover system that the sample can be released from the
logical queue need not be in the physical queue of the inner queue . Upon receiving notice of the release , the vessel
chord of analyzer module 32. In some embodiments , the mover system can note that the sample has been released
vessel mover can operate track sections quickly enough that from the logical queue by updating its status and memory at
the logical queue for the analyzer module 32 can also step 102. At step 104 , additional modules within the ana
include samples 54 and 56. That is , so long as there is no lyzer system can be notified that the sample is ready to be
scheduling conflict between analyzer module 34 and ana released . For example , at step 106 , the vessel mover can
lyzer module 32 , the vessel mover can present the appro notify the analyzer module that it received the request and
priate sample to analyzer module 32 on an as - needed basis , the sample should be released from the logical queue . Upon
greatly expanding the logical size of the available queue for receiving this notification , the local analyzer module com
each analyzer module . Additional examples of how logical pletes the release of that patient sample from its logical
queues can be used instead of traditional physical queues in queue, removing it from the memory structure representing
certain embodiments can be understood with respect to U.S. a queue of samples. At step 108 , the vessel mover deter
Patent Application Publication No. 2015/0118756 . mines whether it is physically feasible to remove the sample
[ 0160 ] FIG . 9 shows the exemplary software flow 80 for from the physical queue on the local track segment. For
handing off samples between the vessel mover system and a example, in a system operating in a counterclockwise traffic
local analyzer module in an exemplary embodiment, pattern , if the sample being released is not the counterclock
whereby a local analyzer module maintains a logical queue wise -most sample on the local track segment, releasing that
of samples in software, but relies on the vessel mover system sample would require flushing any intervening samples onto
to do the actual positioning of sample tubes in carriers on the main track to cycle back around the vessel mover system
tracks, including the local internal track to that analyzer to be placed back into the local queue at the tail of the
module . Thus, the vessel mover system will be responsible physical queue. In some embodiments, even though the
for physically moving a patient sample into position for main track loop operates in a counterclockwise manner, the
interaction with the pipette used by the local analyzer to local track segment may be capable of moving the clock
perform sample aspiration . At step 82 , the vessel mover wise -most sample onto the main track loop if there is
system moves a sample having a known sample ID into sufficient free space on the main track loop . This is similar
position at the analyzer module . At step 84 , the vessel mover to the way one might back a car out of the driveway onto a
controller notifies the local analyzer that there is a new road before traveling forward on that road .
sample available for the queue for that analyzer. At step 86 , [ 0163 ] If it is not physically feasible to immediately
the local analyzer adds that sample ID to a logical construct remove the sample from the local queue, at step 110 , the
for the random - access queue . At step 88 , the local analyzer vessel mover determines whether or not it can safely shuffle
module selects the next sample within its logical queue to the local track segment physical queue , such that any sample
perform an aspiration . This next sample may be any sample carriers between the carrier having the sample to be released
within the random - access queue, including the sample that and the exit track segment will be flushed onto the main
just arrived . This step is done using a local scheduling track so that the released sample can exit . This decision can
algorithm containing software instructions executed by a be based on local traffic status, such as whether there is
processor local to the analyzer module . This allows the local sufficient time to release a sample onto the main track
analyzer module to have autonomy in managing its local segments, or whether doing so would require flushing
queue . nearby samples from the physical queue that will be needed
[ 0161 ] At step 90 , the local analyzer module processor
2 within too short a time to facilitate the flush . If a local queue
requests the next sample for aspiration based on the selec flush procedure is feasible, at step 112 , the vessel mover
tion and step 88. The local analyzer module then commu moves the appropriate intervening samples onto the main
nicates the sample ID being requested to the vessel mover . track segment, as well as the sample to be released . Those
At step 92 , the vessel mover uses the local track segment to intervening samples will then travel around the main track
move the requested sample into position at the pipette loop and be returned to the tail of the physical queue in the
station of the local analyzer module . Once this step is local analyzer module. The released sample will then be able
completed , at step 94 the vessel mover notifies the local to move to its next destination. Once the sample is released ,
analyzer module that its request has been filled , and the at step 114 the planner module within the central computing
sample is ready for aspiration . At step 96 , the local analyzer system of the analyzer system is notified by the vessel mover
module moves the sample aspiration pipette into position to that it is ready to move to its next destination . The planner
aspirate a sample from the requested sample tube . At step 98 , module will then interact with the vessel mover to determine
an aspiration is performed by the pipette and it is determined the next destination , and physically move that sample to that
by the processor in the local analyzer module whether destination .
sufficient volume has been aspirated from the sample , or
whether it must request the sample again ( e.g. , such as Software Interfaces
requiring the sample to stay for an additional aspiration
cycle ) . For example, if it is determined that additional [ 0164 ] In addition to the concepts discussed above, soft
volumes of a sample fluid may be needed immediately, or in ware parameters can be used to store data about the status of
the near future , that sample can be maintained in the logical samples, carriers , and systems within an analyzer system .
queue for that analyzer module, but the sample may not be These parameters may also be used to communicate infor
immediately needed at the location of the pipette, freeing up mation about states of these objects. The following are some
the pipette to interact with additional samples. examples of data can be stored and passed between software
[ 0162 ] At step 100 , if sufficient volume has been aspirated , modules during operation of an analyzer system in accor
the local analyzer module controller will notify the vessel dance with some embodiments .
US 2022/0308078 A1 Sep. 29, 2022
16
[ 0165 ] The following is an exemplary message , whereby to receive control and calibrator tubes and provide a thermal
the vessel mover tells an analyzer module that a new sample sink to chill these tubes . In addition , individual evaporation
as being made available to the local random -access sample covers that are sized to engage the tube base assembly are
queue. Such a message includes the following information : placed above each tube. These covers are sized so as not to
[ 0166 ] Sample ID : This is an identifier that uniquely make direct contact with the tubes to avoid cross contami
identifies the samples within the analyzer system . This nation . Base assembly 118 of the cold chamber includes a
parameter is the link to the work order, or test , to be housing having insulated walls and mounting positions for
pipetted. thermoelectric coolers (TECs ) that are in thermal contact
[ 0167 ] Primary /Secondary Tube Flag : This parameter with the stainless base of base assembly 117 .
identifies to the analyzer module whether the sample is [ 0176 ] FIG . 10B shows an exemplary cooling module 120
a primary tube ( e.g. , it contains red blood cells ( RBCs ) ) for use with exemplary control storage modules. In this
or a secondary tube ( e.g. , contains no RBCs ) , used with embodiment, three thermoelectric devices ( TEDs ) are
blood samples. responsible for cooling refrigerated storage used for storing
[ 0168 ] Tube Type: This parameter identifies to the ana control and calibrators . Each thermoelectric device is an
lyzer module which classification of supported tube is assembly comprising a thermal pad , one or more Peltier
associated with the sample. modules, heatsink fins, and aa fan to remove heat from the
[ 0169 ] Tube Top Sample Cup Flag : This parameter fins. Modules comprising each TED and heatsink hardware
identifies to the analyzer module whether the sample are identified as TED module 122 in FIG . 10B . Cooling
tube is carrying a supported tube top cup on the sample occurs due to the Peltier effect, which works by passing
tube. electric charge through a junction of two different conduc
[ 0170 ] The analyzer module may communicate a request tors , creating a hot side and a cold side . The cooled surface
to the vessel mover for the next sample to be placed at the is thermally connected by pinching a graphite thermal pad
physical location of the analyzer module’s pipette. It can between a TED cold surface and a cold plate mounting
contain the sample ID as an argument. surface . The hot side is connected to a series of fins, which
[ 0171 ] Another vessel mover -to - analyzer message is a allow air to be blown and remove heat . The series of
“ notify sample okay ” message , whereby the vessel mover thermistors 124 can be placed throughout the bottom of the
instructs the analyzer module that the sample is in position cold plate. For example, three can be mounted directly to the
to be pipetted . In some embodiments , an analyzer module mounting blocks for the TEDs , and two additional therm
may access multiple pipetting positions. Accordingly , in istors can be located near the ends of the system for
those embodiments, the sample ID and an ID of the position additional measurement capability. A control module can
at which that sample has been placed are passed as argu then utilize the thermal input from each thermistor 124 to
ments in the “ notify sample okay” message . provide control to activate TEDs 122. Various thermal
[ 0172 ] When an analyzer module has finished processing tuning approaches as known in the art can be applied . In
a sample, the analyzer module may send a “ notify release some embodiments, a potential integral differential (PID )
sample from the queue ” message to the vessel mover . This controller is used to control each TED 122. In some embodi
message indicates that the sample is no longer needed by ments, a local averaging of thermistor values can be used to
that analyzer module. It includes the sample ID as a param provide individual control to each individual TED . In some
eter.
[ 0173 ] Similarly, when the vessel mover has successfully embodiments, an average of all thermistors can be used to
control all TEDs in unison . Other exemplary control
released the requested sample from the local queue of the approaches include using a proportional controller, a pro
analyzer module, the vessel mover may respond with a portional integral controller, and a simple threshold thermo
“ notify sample is released ” message containing the sample couple approach .
ID . It should be noted that the preceding messages are [ 0177] In an exemplary embodiment, proportional integral
illustrated with respect to the software flow in FIG . 9 . (PI ) tuning is used . Integral PI controllers are commonly
Refrigerated Storage used for temperature control, especially on systems with a
large time constraint. The method used to tune the coeffi
[ 0174 ] Refrigerated storage for controls and calibrators cients for the control storage module in this example, the
provides long -term storage of multiple days for controls and Ultimate Sensitivity Method, developed by John G. Ziegler
calibrators in sample tubes. This is accomplished by pro and Nathaniel B. Nichols . The following explains exemplary
viding a refrigerated humidity /evaporator controlled envi steps in the method . The first step is to set ki =0 . kl is the
ronment in the refrigerated storage in the sample handler integral coefficient of the controller. Start off with aa small kP,
module . In some embodiments, by providing an enclosed and wait until the response stabilizes. KP is the proportional
refrigerated environment with evaporation covers for each coefficient of the controller. The set - point is changed by a
tube, controls and calibrators can be stored without substan small amount, until the response starts to oscillate . If there
tial degradation or evaporative loss for at least 14 days . is no oscillation in the response , increase kP by a factor of
[ 0175 ] FIG . 10A is an exploded perspective view of an two and repeat. This method continues until oscillation is
exemplary control storage module 120. The primary com seen in the response signal. During this step of the tuning
ponents of control storage module 120 are tube access door process in an exemplary refrigerated control storage module ,
assembly 116 , which covers tube and evaporation cover base values of kP =300 , 400 , and 350 were used in that order. 350
assembly 117 , which is contained in the base assembly 118 , was found to be the proper gain Ku, resulting in a period of
which forms aa cold chamber. Tube access door assembly 116 oscillation in temperature of 93 seconds . This results in the
provides a sealed door to contain control and calibrator following equations for use with aa PI controller : kP= 350/2 .
tubes. Tube and evaporation cover base assembly 117 2 = 160 ; kI= 1.55 / 1.2 = 1.3 ( 93 seconds = 1.55 minutes ). The
includes a stainless baseplate having a plurality of recesses last step of the method is to test and confirm .
US 2022/0308078 A1 Sep. 29, 2022
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[ 0178 ] Operating the control storage tuning process with holding force . By using a “ v ” and the spring , tubes stored in
kP = 160 , kI = 1.3 and kD =0 in an exemplary embodiment these recesses can be held upright in a repeatable position for
resulted in cooling at 0.427 ° C./min . starting an ambient more accurate engagement by the robot arm .
temperature of 17 ° C. With three TEDs turned fully on and
direct - current of 8.5 A , the module remains stable after Sample Handler Robot Subsystem
reaching steady - state and under PI control. While starting [ 0182 ] An exemplary sample handler robot that may be
with the module at an ambient temperature of 17 ° C. , an used with sample handler modules includes the robot gantry
exemplary control storage module reached steady state in having a Cartesian robot , with three axes orthogonal to one
34.5 minutes. Steady state can be defined as maintaining another. The gantry is set up with four linear, brushless DC
temperature within 1 % of the set -point temperature of 4 ° C. motors . Two motors are used for the gantry Y - axis, one for
In an exemplary embodiment, the undershoot was 0.25º C. the X - axis and one for the Z - axis . Linear motors include a
( 6.25 % ) , and the settling time to reach steady state after magnetic rod , a forcer, and aa ball bearing slide , all mounted
crossing the set -point was 6.5 minutes. With a cooling rate to a frame. Coils reside in the forcer, which is guided by the
of 0.427 ° C./minute and a settling time of 6.5 minutes, the slide and moves along the magnetic rod . An exemplary
calculated time it would take for the module to reach the gantry configuration is shown in FIG . 11 .
set -point of 4 ° C. would be (30 ° C. - 4 ° C . ) / (0.427 ° C./min [ 0183 ] Robot arm 130 includes two parallel Y - axis linear
ute ) +6.5 minutes = 67.3 minutes. In an exemplary embodi motors 132 having 900 mm of travel. By having parallel
ment, 30 ° C. is the maximum ambient temperature for the Y - axis linear motors , X - axis linear motor 134 has a stable
operating range of the system . Using the same formula, the platform that allows the entire X - axis linear motor 134 to
cooling time would be 79 minutes for an ambient tempera travel orthogonally to the Y - axis linear motors . X - axis linear
ture of 35 ° C. In an exemplary embodiment, 35º C. is the motor 134 has approximately 660 mm of travel in this
estimated maximum temperature underneath the covers of embodiment. Riding along X - axis motor 134 is an assembly
the sample handler module , which contains the refrigerated including the Z - axis linear motor 136 , which has 150 mm of
control storage module. vertical travel. Signals and power can be provided by cable
[ 0179 ] In some embodiments , the tube access door assem chain carriers 137 , preventing cables from tangling as robot
bly 116 comprises two doors that open in a sliding fashion . arm 130 moves around . X and Y -axis linear motors 132 and
In some embodiments, one or more motors may provide the 134 form a gantry to position Z - axis motor 136 directly
actuation of the doors . Some embodiments, such as that above a sample tube or carrier. At the lowest point of robot
shown in cross - sectional view 10C , provide passive mecha
9
arm 130 , end effectors 139 provide jaws that can open and
nisms that allow the sample handling robot 20 to provide the close to grab sample tubes or other objects. Once robot arm
actuation of the doors . Tube access door assembly 116 130 is positioned above a sample tube , Z - axis motor 136
includes two doors . One of these doors includes pin 125. Pin descends to the tube, while and effectors 139 open and close
125 is mechanically coupled in a rigid fashion to one of the to capture the tube .
doors, and is configured to engage the gantry assembly of [ 0184 ] In some embodiments, the four gantry motors are
robot arm 20. This allows the robot arm 20 to move into controlled by three Copley Accelnet controllers /amplifiers .
position to engage pin 125 , and move that pin into an open Two Y - axis motors are used in order to distribute the load of
or closed position . Rack and pinion 126 allows the engage the X - axis , Z -axis, and robot end effectors . Since the two
ment of pin 125 to cause the two doors to move in opposite Y - axis motors always move together, they are controlled by
directions, providing an opening or closing motion by a single Accelnet controller /amplifier to ensure synchronic
engagement of pin 125 by robot arm 20 . ity.
[ 0180 ] FIG . 10D is an exploded perspective view of tube [ 0185 ] The end effectors of the robot gantry subsystem can
and base assembly 118 . be referred to as a gripper. The primary purpose of the robot
Evaporation covers 127 are configured to rest in recesses of gripper is to grab, hold during transport, and release trans
2
top plate 128. Top plate 128 can be a plastic array of portable items . Transportable items include sample tubes,
openings that provides a protective top sheet to base assem control/ calibrator vials , and control storage evaporation cov
bly 118. The openings are sized to accept evaporation covers ers . The gripper may also be able to handle open tubes, tubes
127. Beneath top plate 128 , stainless steel strike plate 129 with caps , and tubes with flanges. It also may be able to
includes an array of holes that are sized smaller than those transport test tubes with tube top sample cups ( TTSCs ) , in
of top plate 128. Evaporation covers 127 will rest on the some embodiments. The robot gripper can include aa crush /
ledge created due to the differences in sizes of these open crash sensor, a stepper motor with encoder feedback , a
ings . In some embodiments, evaporation covers 127 are mechanism for converting rotary motion to linear motion ,
made out of a plastic material , but include one or more and gripper fingers.
magnets at the base of the cover to provide a magnetic force [ 0186 ] In some embodiments, all transportable items can
between evaporation covers 127 and strike plate 129. This be gripped with the same amount of force. Each tube can
allows covers 127 to be securely mated to strike plate 129 . also be designated to have the same grip location . In such
Robot arm 20 can access control calibrators stored in base embodiments, the exact height is determined by the height
assembly 118 by using end effectors to remove each evapo of the shortest tube that system is required to support. In
ration cover 127 , placing that cover on a nearby shelf, and
2 some embodiments, the gripper is designed to grip at an
then engaging the tube underneath using the end effectors for offset from the top of the tube . An estimate of the top of the
removal. tube can be garnered via the DVS , or by mechanical register
[ 0181 ] Base assembly 118 includes a plurality of recesses in the end effectors . A stepper motor drives gripper fingers
sized to accept control and calibrator tubes. In some embodi to open and close through a motion conversion mechanism .
ments , these recesses include two vertical walls forming a [ 0187] In some embodiments the gripper is attached to the
“ v ” and, opposite that “ v , " a leaf spring that provides a robot gantry through the crush / crash sensor. This sensor
US 2022/0308078 A1 Sep. 29, 2022
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provides the ability to sense when the end effector has the electrical current feedback from the amplifier. The
collided with an object in either the vertical ( Z ) direction or velocity feedback used for the velocity loop is the derivative
lateral ( X , Y) directions. The two sensors are connected as of the position signal.
separate inputs to the motor amplifiers. The amplifiers are [ 0193 ] In some embodiments, robot gripper control is
configured such that when the inputs are activated, a flag is operated in servo mode . In servo mode , the control algo
set and the motors will abort motion with a pre - specified set rithm runs the stepper as a true closed loop servo motor with
of motion parameters. The motor can return to operation encoder feedback . Controlling the gripper in this way pro
only after the flag has been cleared . This can aid in prevent vides the ability to control the amount of force the gripper
ing spillage of sample contents in the sample handler. applies to items while they are being grasped. In this mode ,
[ 0188 ] Exemplary crush and crash sensors can include the gripper is controlled in the same way, with the same
additional features to avoid malfunction of the sample control algorithms as the motors in the robot gantry.
handler. The crush function of the gripper allows for some [ 0194 ] In some embodiments, when grabbing a transport
compliance, as well as tube bottoming confirmation and able item , the gripper does not know the diameter of the
placing tubes into sample 1/0 , control and calibrator storage , item . Because of this , the gripper is commanded to move to
and carriers in the track system . During this operation, a its “ completely closed ” position on every grip attempt. In
signal from an interrupter pin traveling through an optical order to be sure the gripper stops its closing motion when it
sensor can signal to the system that a tube has reached the encounters an item , the “ peak current " and " continuous
desired height. The travel distance of approximately 0.7 mm current " parameters in the controller /amplifier are used . The
is required to trip the sensor, in some embodiments . The motor output current correlates to the force output at the
sensor also works to detect when the object being trans ends of the gripper fingers. When the grippers are closing
ported hits a target unexpectedly, as in the case of putting a and they encounter an item , they will grasp that item with a
tube onto another tube. The sensor has additional travel to specific amount of force that correlates to the continuous
allow the robot to come to a stop carefully, without dam current value set in the controller / amplifier. This means that,
aging or breaking the tube. while there is an item in the gripper, the motor has not
[ 0189 ] The crash functionality deals with the tilt of the reached its destination position . Because the motor is servo
robot end effector. Tilt can be caused by side loads applied ing , it will continue to try to get to its minimum position .
from hitting an object not intended during travel. Examples Because there is an item in the way and the motor cannot
include hitting the leading edge of a sample carrier tube slot . move , it will continue to grasp the object it is holding with
This compliance allows the robot to come to a stop and a specific force value correlated with the continuous current
prevent damage /dropping the transported object. value in the amplifier. In other embodiments, the gripper
[ 0190 ] In some embodiments, end effector gripper fingers may have aa model for the diameter of the item it is picking
up based on the results of the DVS or TCS . This can mitigate
include a rubber portion, such as an O -ring , that allows some the need for force feedback in the motor control.
compliance and cushioning as the fingers grab a sample [0195] FIG . 12 shows an end effector assembly 140 that
tube . In some embodiments , the bottom geometry perform includes end effectors 139. End effector assembly 140
ing the holding of a tube is designed to be bound between the travels vertically at the control of the Z - axis motor 136. End
top of a tray and the bottom of a cap for the smallest effectors 139 are actuated via actuators 142. Actuators 142
expected tube size , such as a 65 mm tube. In some embodi can be servomotor actuators that allow the end effectors to
ments, this allows approximately 15 mm of vertical play in open and close , and provide aa feedback signal as to the state
which the end effectors are to make contact with the smallest of these end effectors. This feedback signal can be used to
available capped tube . determine if a problem is encountered when engaging a tube .
[ 0191 ] In some embodiments, four motors are used, but At the top of end effector assembly 140 is a compliance
only three controller / amplifiers are used . The Y -axis utilizes sensor 144. Compliance sensor 144 provides a sensory
two motors to distribute the load of the X - axis , Z - axis , and
2 feedback signal as to the crush and tilt status of the end
robot end effector. Both of these motors are controlled by a effector assembly.
single controller / amplifier. In order to do this , the amplifier [ 0196 ] FIG . 13 provides additional details about compli
outputs are connected to both motors , and the motor feed ance sensor 144. This cross - sectional view of compliance
back connections are tied together. However, the amplifier sensor 144 illustrates an exemplary mechanism for detecting
and the software can be unaware that there are two motors . tilt and crush status of end effector assembly 140. The tilt of
This allows for easy control since the Y - axis can be treated end effector assembly 140 can be determined using a tilt
the same as any other axis. Since the two motors of the tactile sensor PCB 146. A plurality of tactile pressure sensors
Y - axis are mechanically tied together, controlling them or optical sensors arranged in a ring can detect any asym
separately can be very difficult. One solution is to use two metric movement of compliance piston 148 relative to
separate controller/ amplifiers , one for each motor. However, compliance sensor housing 150. Any asymmetric movement
because two control algorithms can be running to control the relative to the ring of tactile sensors in tactile sensor PCB
position of a single mechanical load , without near perfect 146 will indicate that the end effector assembly 140 is being
synchronization, the two algorithms would likely be con pushed off axis and tilting .
stantly fighting each other . [ 0197 ] Compliance piston 148 is concentrically engaged
[ 0192 ] In some embodiments, the gantry robot subsystem with crush plunger 152. This engagement can include an
uses controllers in servo position mode and in position axial sliding relationship , allowing crush plunger 150 to
mode , the overall control algorithm is composed of three slide in and out of compliance piston 148. Meanwhile, off
nested control loops . These include a position loop , velocity axis forces applied to crush plunger 152 can affect the tilt of
loop , and current loop . The algorithm utilizes two feedback compliance piston 148. Crush sensor 152 receives a down
signals. These are the position feedback from the motor and ward force from crush spring 154 that pushes crush plunger
US 2022/0308078 A1 Sep. 29, 2022
19
152 away from compliance sensor housing 150. As vertical power to each carrier to allow it to reach a maximum speed
forces are applied to end effectors 139 , such as when the end
2 on straight track sections of 6 m / s .
effectors encounter an unexpected object during a vertical [ 0200 ] In some embodiments, track sections are divided
motion , crush plunger 152 will compress spring 154 and up into a number of coil boards . A coil board includes a
move relative to compliance sensor housing 150. Hence , any linear array of coils that can be mounted underneath the
motion of the crush plunger relative to housing 150 will metallic ( non - ferromagnetic ) surface of the track . For
indicate that a crush situation is occurring. The distance that straight sections of track, each coil board is straight, while,
crush plunger 152 moves , relative to housing 150 , is pro in corners or curves, coil boards include appropriately laid
portional to the force of the crush , as governed by Hooke's out coils to match the curve . All coil boards are controlled
law with respect to spring 154. An optical sensor 156 by master boards and node controllers . In some embodi
coupled to housing 150 can detect the relative distance or ments, each master board can control up to eight different
motion of crush plunger 152 relative to the housing. Dis coil boards. Meanwhile, a node controller is centralized . A
tance can be determined in any conventional way, including single node controller can control the entire vessel mover
time of flight reflections, an optical measurement, or by track . In some embodiments, multiple distributed node con
observing the relative motion of an encoded rod that moves trollers can be used for expandability. For example, in larger
with crush plunger 152 into housing 150. In some embodi systems , where the track extends for several meters , multiple
ments, the mechanical encoder can be used in place of node controllers may be used , and control of carriers can be
optical sensor 156. An electrical signal can be provided by handed off as they traverse different regions of the track
optical sensor 156 to indicate the amount of crush force network .
being experienced. [ 0201 ] Vessel mover manager software can reside on the
[ 0198 ] Meanwhile, if there is a lateral component to the host PC that communicates with the node controller for the
crush force, the concentric engagement between crush physical track through a network switch . In some embodi
plunger 152 and compliance piston 148 will cause compli ments, multiple node controllers can be used for redundant
ance piston 148 to move , relative to the central axis, causing failover, with a single node controller handling normal duty,
it to tilt . Tactile sensors 146 can then detect this tilting event. while a second alternate node controller is prepared to take
The electrical signals from tactile sensor PCB 146 and over should the primary node controller fail. In some
optical sensor 156 can be provided to a processor that embodiments, the primary and secondary node controllers
controls the motors in robot arm 130 . can have the exact same software operation and design, but
Vessel Mover Architecture different IP addresses, allowing seamless failover. Each
node controller is connected to the master boards through
[ 0199 ] In some embodiments, the VM track uses distrib network switches within the analyzer system . In some
uted power sources . Each track section is associated with an embodiments, there are two layers of network switches . A
analyzer module or a sample handler module . Standalone top level Ethernet switch is part of the central utility center
track sections placed between these modules can be asso for the PCM system . This can be connected to a series of
ciated with either of the modules. Each track section is gigabit Ethernet switches in daisy chained fashion . Each of
powered by the module to which it is physically resident, as these switches can serve double duty as the power controller
well as one adjacent module . In some embodiments, deter for each module, providing both network switching and
mining which adjacent module to draw redundant power failover power control. In this arrangement, each gigabit
from utilizes the following convention . Looking at the switch is connected to each switch in the adjacent modules .
boundary between analyzer modules and sample handler While this daisy - chained arrangement may result in broken
modules (e.g. , track section 36 ) , the adjacent module that
9 communications should a network switch fail, these
provides redundant power is always the module nearest that switches can be designed to be hot - swappable for easy
boundary. Each track section is powered by the current resolution . Moreover, the expected failure rate of these
module and the module prior. Here , “ prior ” is described as network switches is much lower than that of the power
the module closer to the SH / analyzer module boundary. The systems of each module . The linear motors that make up the
U - shaped track around an analytical module is powered track can communicate with each local master board via
through the power source of that analyzer. As a backup, the these gigabit switches .
U - shape is connected to the previous analyzer power source . [ 0202 ] FIG . 14 shows a perspective view of track system
The controller module at each power source can identify a 160. Track system 160 is configured to have a single sample
local power failure and automatically switch over to the handler unit and two analyzer modules. FIG . 15 shows track
adjacent redundant power source . For example , if the current system 160 situated in a fully operational analyzer system
analytical module needs to be taken off line for service, or 162 that includes a sample handler module 10 and two
is down due to an internal failure , then the power controller analyzer modules of 32 and 34. As can be seen , track system
for each track section will switch the power source for the 160 is housed within the modules themselves, such that the
track to the power source provided by the previous /adjacent track is not easily accessible to an operator. However, track
instrument. This way , the track operations can continue even 160 and analyzer system 162 utilize a modular design
if one of the power sources is down . In some embodiments, whereby track components reside within each module and
the power system module for each U - shaped track is located each module can easily be linked together to join the track
proximate to the straight track section at the back of the segments by placing adjacent modules in proximity and
instrument. The power is distributed to the linear motor in linking them . Lids above track 160 can be removed during
the front of the analyzer from the power controller. A power installation or service to facilitate linking of tracks . In some
cable can be routed through the analytical module itself to embodiments, track sections and expanded by placing mod
that front track section . In some embodiments , each track ules adjacent to one another and bolting the track sections of
section works with 24 VDC , which provides sufficient each module together forming a single multi -branching track
US 2022/0308078 A1 Sep. 29, 2022
20
system , such as track 160. Signaling cables can be daisy segments 184 is generally T - shaped, with rounded inside
chained together for ease of expanding control. edges. Meanwhile, the rails of switching segments 184
[ 0203 ] FIG . 16 shows a cross - sectional view of the track include one straight rail (top of the T ) , one radiused rail (one
section 170. Track section 170 may be track section used in inside corner of the T ) , and one radiused rail that includes a
track 160. In this embodiment, carriers ride between rails switching mechanism ( other inside corner of the T ) . This
172 on a track surface 174. In some embodiments, rails 172 switching mechanism is a movable rail component that can
are aluminum extrusions that also include vertical sides on be turned a predetermined number of degrees to act as a
the exterior of the track components underneath track sur switch (e.g. , 20-30 degrees, depending on geometry ). On
face 174. These aluminum extrusions can include brackets to one side of the rail component, it acts as a straight rail. On
easily bolt internal components to these side pieces to form the other side of the rail component, the rail presents itself
a track unit . Track surface 174 is preferably a non -ferro as a radiused rail forming an outside corner of a turn . By
magnetic stainless steel surface, making it durable and easy switching a movable rail component, that movable rail
to clean . It should be appreciated that other materials can be component can either provide the outside of a turn , or a
used for rails 172 and track surface 174 , such as aluminum , simple straightaway rail. Thus, the mobile component pro
stainless steel , composite materials, etc. At the bottom of the vides a binary switch whereby switching segment 184
side components of rails 172 resides a baseplate 176. Base presents itself as a turn or as a straightaway, depending on
plate 176 can be mounted to the modules containing track the control signal. This can be used to divert individual
section 170 and provide support for the track system . carriers based on the state of the switching segment. It
[ 0204 ] Beneath track surface 174 reside a series of coils should be noted that, while the track may be bidirectional,
180. The longitudinal direction of track section 170 is into only one end of the T can be connected to the center portion
the page ; as you travel along the track section 170 , you of the T to form a turn . Thus , while switching segments 184
encounter additional coils 180. Coils 180 are preferably may have three ports, essentially, one port may be switched
mounted to coil boards 182 and are preferably laterally to either of the other two ports , but those two ports cannot
oblong to allow more coil density in the longitudinal direc be joined together.
tion of the track . In some embodiments, coil boards 182 are [ 0206 ] A simpler type of track section is a straightaway,
printed circuit boards (PCB ) that include several coils 180 in
the longitudinal direction . An exemplary coil board is 250 such as outside straightaway 186 or inside straightaway 188 .
mm in length , accommodating all of the coils 180 needed for The basic components of straightaways 186 and 188 are a
250 mm of track . Thus, a typical track section will have track surface and rails, with a series of coil boards providing
several coil boards 182 , including dozens of coil boards 182 linear motive forces along the direction of that straightaway.
to make up an entire track system . In some embodiments, Straightaways 186 and 188 are identified separately in FIG .
coil boards 182 receive a control signal to indicate the 17 because inside straightaways 188 can be operated under
trajectory to apply to aa carrier traveling along that coil board the control of the local module, rather than a vessel mover
and a power source of 24 VDC . Coil boards 182 include controller that controls the entire track 160 , in some embodi
coils 180 , motor drivers to drive those coils , and one or more ments . This allows each local module to independently
sensors to detect the presence of carriers traversing the track operate track sections 188 to act as a local random - access
surface above the coil board by detecting the magnets of the queue. The vessel mover controller can hand off control to
carrier. These sensors can include Hall Effect sensors to the local module after moving a carrier from a switching
detect the presence and location of the carrier traveling segment 184 to the local inside straightaway 188. Similarly,
along the coil board . Accordingly, there may be more when aa local module has completed aspirations on a sample
sensors than coils , allowing fine resolution of the position of residing on inside straightaway 188 , that module may move
a carrier traversing track surface 174. Furthermore , an RFID the sample carrier into a switching segment 184 and hand off
receiver may be utilized to receive an RFID signal that control to the vessel mover controller. In some embodi
identifies the carrier traveling along the track surface . In ments, inside track sections 188 still operate under the
some embodiments, magnetic signatures unique to each control of the vessel mover controller that controls the entire
carrier can be detected by the Hall Effect sensors to deter track system 160. To control aa local queue on inside straight
mine the identity of the carrier magnetically. For example, a away 188 , the local module can communicate directly with
carrier traversing an array of Hall Effect sensors can be the vessel mover controller to request movement of carriers
characterized at manufacturing to identify a unique signature within track section 188. This allows the local module to
of that carrier based on rise times and signal artifacts that are manifest control over carriers in its queue by using a request
detected by the Hall Effect or sensor array as magnets in the to acknowledge the communication system , allowing the
carrier travel over that array . In some embodiments, smaller vessel mover controller to have expertise in moving indi
magnets than the main drive magnets may be placed in the vidual carriers and operating track system 160 .
bottom portion of aa carrier to intentionally create a unique [ 0207] A fourth type of track segment is a curved track
signature for each carrier at manufacturing. This magnetic segment 190. Curved track segment 190 provides a 90 ° bend
signature can be correlated to an identity of each carrier in with a predetermined radius (or other angular bend ). This
software for the vessel mover system . An exemplary linear radius is preferably the same as the radius used in turns when
synchronous motor drive system is described in U.S. Pat . switching track segments 184 are switched into a curve . The
No. 9,346,371 . radius is chosen to minimize the space impact of curves
[ 0205 ] FIG . 17 shows a top view of an exemplary track while , at the same time , allowing carriers to move quickly
system 160 with the individual track sections identified . around curves without encountering drastic lateral forces .
There are generally four types of track sections that make up Thus, the space requirements and speed requirements of
the modular design of track system 160. Switching segments automation track 160 can determine the radius of curved
184 are branches in the track . The track surface for switching segments 190 .
US 2022/0308078 A1 Sep. 29, 2022
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[ 0208 ] Electrically , curved segments 190 are substantially and accesses the power feed supplied by the adjacent PFGE
the same as straightaways 186 and 188. Each of these switch from region 196. The PFGE switch for region 194 , in 9
segments includes a plurality of coils that are activated, in turn , provides a power feed to the PFGE switch for region
sequence, to provide a linear motor in conjunction with 192 , should that section need power when local module
magnets in the bottoms of carriers . Each coil is activated to power fails. Should module 34 lose power such that the
provide a push or pull force on drive magnets placed in the PFGE switch for region 192 cannot access the local power
bottom of each carrier. The speed at which coils are activated feed, that PFGE switch can detect the loss of local power and
in sequence determines the speed of the carrier on that access the power feed supplied by the PFGE switch for
section of track . Furthermore, carriers may be moved into a adjacent region 194. In this manner, should analyzer module
position and stopped at a predetermined location with high 32 or 34 fail, local track sections continue to get power
resolution by activating coils at that location . supplied by the power source for the module in the adjacent
[ 0209 ] FIG . 18 shows the various control zones for a region.
vessel mover controller controlling track 160. Each dashed [ 0211 ] Additional details about these exemplary power
box represents a different control zone that is controlled by failover redundancy techniques and systems for use with
a separate master board . Coil boards within those track some embodiments can be found in simultaneously filed
segments, or portions of track segments, are operated under U.S. Provisional Patent Application No. 62 / 365,194 ; which
the control of aa different master board for each control zone . is incorporated herein by reference in its entirety.
This assists the scalability of track management. A node [ 0212 ] FIG . 20 is a top view of an exemplary portion 200
controller can control several master boards, communicating of track 160. Exemplary track portion 200 includes a plu
with them via a network . Meanwhile, each master board can rality of coil boards that are controlled by a single master
control individual coil boards for the region of the track that board . FIG . 21 shows the same exemplary track portion 200
each master board controls . Each master board can commu with the coil boards and master board that controls them ,
nicate with the coil boards to receive sensor information with the physical track stripped away. Master board 202
identifying the position and location of each carrier , and receives control instructions from the vessel mover control
manage the trajectory of each carrier via control signals sent ler /node controller. Master board 202 , in turn , uses those
to each coil board . Each master board receives trajectory instructions to control coil boards 204 and 206. Master board
information for local carriers from a node controller. This 202 also receives sensor data from coil boards 204 and 206 .
allows each master board to govern a small section of track , In this example, there are five coil boards 204 associated
carrying out the real- time control of that section of track , with an outside track straightaway section , and one coil
based on the information received from the controller, to board 204 associated with an interior track straightaway
handle overall management tasks of the entire track system . section . Coil board 206 controls the switching track section .
In the exemplary embodiment shown in FIG . 18 , there are Each of coil boards 204 has a series of coils arranged in a
eight master board control zones . Each master board is also line, and an array of Hall Effect sensors . The coils are
responsible for managing any switching track segments 184 powered by local drive circuitry (e.g. , high current ampli
within its control zone to direct a carrier to the appropriate fiers ) on coil boards 204 , and are activated , sequentially, at
point of exchange with the next control zone. the control of master board 202 to drive the carrier along a
[ 0210 ] To further divide management of the track system , linear track section . Drive magnets in the carrier are
and to provide power failover redundancy , the track system attracted or repelled to those coils as the carrier moves along
can be divided into different regions, roughly corresponding the stainless steel track surface placed above these coils .
to each module within the system . Region 192 corresponds Hall Effect sensors detect the passing ma ts , allowing the
to analyzer module 34 , while region 194 corresponds to coil board to have feedback for controlling the coils . Infor
analyzer module 32 , and region 196 corresponds to sample
2 mation collected from the sensors can also be communicated
handler 10. It should be noted that multiple master boards to master board 202. For example, identifying information
are encompassed within each of these regions. Redundancy about a carrier may be communicated, as well as position
can be accomplished by assigning a power failover gigabit information about the carrier can be communicated . Coil
Ethernet ( PFGE ) switch to be in charge of providing net boards 204 can also have an RFID receiver, in some embodi
work and power to each of these regions . Each PFGE switch ments .
provides local networking between each master board and [ 0213 ] Coil board 206 includes a series of coils , in the
the node controller. Each PFGE switch also provides power same manner as coil boards 204. However, because coil
to the local region of track . By utilizing a switch to provide board 206 controls aa switching section , coils are arranged in
power, power redundancy can be achieved . In this example , a branch . Furthermore, coil board 206 is responsible for
the PFGE switch for region 196 accesses a local power actuating ( e.g. , actuating a servo motor coupled thereto ) the
source to provide power to each master board in this region . switching member that alters the guide rail in the switching
That PFGE switch also provides a power channel that may section to redirect the carrier. In some embodiments, the
be accessed in the adjacent PFGE switch for region 194. The configuration of coils in coil board 206 limit the need for the
PFGE switch for region 194 has normal access to a local guide rail that is physically switched . As a carrier is moved
power source provided by the local analyzer module . Should into a turn , coils along that route push and pull the carrier in
that local analyzer module fail, be turned off, or need an arc magnetically. The guide rail switching member can
servicing, that power supply can be interrupted. However, it assist in that movement but , in some embodiments, rarely
is desirable to still allow analyzer module 34 to operate makes contact with the carrier due to the magnetic guide
while analyzer module 32 is being serviced . To accomplish forces. In some embodiments, the coil boards are controlled
this, the track sections in region 194 and 192 need to by master board 202 via aa serial peripheral interface ( SPI )
continue to operate. To accomplish this, the PFGE switch for bus , which facilitates serial communication between the
region 194 detects the loss of power from the local module master board and the coil boards .
US 2022/0308078 A1 Sep. 29, 2022
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[ 0214 ] FIG . 22 illustrates the network control architecture the small target of a tube top cup . Moreover, by mounting
for the vessel mover system . Vessel mover PC 208 acts as a the bottom and edges of the track at a known position
master controller for the entire vessel mover, and provides relative to each pipette , a pipette can reliably enter into a
an interface for an operator or laboratory information system tube or tube top cup without interference from sidewalls, and
to interact with the vessel mover system . PC 208 can oversee that pipette can reliably determine the fluid height level
the scheduling of tests and assignment of destinations for based on capacitance. A capacitive fluid level sensor utilizes
individual samples, maintaining a database of status of each the known conducting properties of a pipette and measures
sample and tests to be performed . PC 208 provides overall the capacitance when placed in a fluid . By having a reliable
management of the vessel mover , but lower- level manage tolerance for the bottom of the vessel in which that fluid sets ,
ment may be left to other modules. PC 208 interacts with this capacitive signal can give a reliable estimate of the
other modules within the vessel mover system via Ethernet sample volume remaining.
switch 210. For example, PC 208 can communicate with one
or more node controllers 212 . Carriers
[ 0215 ] A node controller 212 is responsible for mid - level
management and routing of the samples within the vessel [ 0218 ] The vessel mover system interacts with a plurality
mover system . It operates at the overall control of PC 208 . of carriers to transport samples, as explained throughout.
However, routing decisions, trajectory decisions, traffic FIG . 23 shows a perspective view of an exemplary embodi
management, etc. , are governed by software in node con ment of a carrier for use with the vessel mover system .
troller 212. Multiple node controllers 212 are illustrated Carrier 220 is configured to support place and pick move
because control can be shared amongst multiple node con ment of samples into , and out of, the carrier. The left-hand
trollers in a load balancing fashion . For example, regions of slot is configured to receive a sample that is placed between
automation track can be assigned to different node control a set of four tines 222. The right-hand slot is configured to
lers , or management of individual carriers can be assigned to receive a sample that is placed between the set of four tines
different node controllers . In exemplary embodiments, dur 224. These sets of tines are symmetric and mirrors of each
ing normal operation , a single primary node controller 212 other. Between the sets of tines , a central member 226 acts
is used for all management of the vessel mover system . as a fixed tine and includes a set of springs 228 to provide
Meanwhile, a secondary standby node controller 212 is a force to push each sample tube into the set of four tines .
available, should the primary node controller go off - line . While this does not result in centering of different size
That secondary node controller can maintain memory that samples within each sample slot ( along the longitudinal
includes the status of all carriers in the vessel mover system axis ) , the force provided by springs 228 and the shape of
to aid in taking over , should the primary node controller fail. tines 224 and 222 will center each sample tube laterally, at
This provides redundancy and / or hot-swapability, allowing the longitudinal axis of the carrier / tines. The arrow shows
the vessel mover to continue in the event of an off - line node the longitudinal direction of travel of carrier 220. The tines
controller. allow the sample tube to be registered at a fixed location in
[ 0216 ] Node controller 212 communicates with master the longitudinal direction such that the center of the sample
boards 202 via Ethernet switch 210. As explained above tube will depend on the radius of the sample tube, but is
with respect to FIG . 19 , local networking within a region of easily repeatable based on the size of each sample tube .
track can be governed by a PFGE switch assigned to each [ 0219 ] Supporting a top plate having these tine sets is
region . In this example, PFGE switches 214 are daisy body 230. Body 230 acts as a housing that includes any
chained from switch 210 to provide an Ethernet network onboard circuitry, such as RFID tags , as well as two or more
between node controller 212 and each master board 202 . drive magnets that allow the carrier 220 to form a linear
Node controller 212 can communicate over this Ethernet motor in conjunction with coils in the track surface . The
network to give instructions and receive status information sidewalls of body 230 can be adapted to interface track rails .
about carriers from each master board 202. Each master For example, to facilitate alignment during movement in
board 202 then controls local coil boards 204 and 206 via a straightaways and around fixed radius curves, the sidewalls
serial port on that master board . Thus, node controller 212 of the body can have the following exemplary features. An
can control the coils in the track , without communicating upper portion of a sidewall of body 230 includes a concave
directly with each coil board . This aids in scalability of the section 232. This concave section can interface the inside
track system . corner of the curve , as shown in FIG . 26. Meanwhile, at the
[ 0217] As a practical matter, the track of the vessel mover vertical edges of concave section 232 , short, flat sections
should be at a well - defined height relative to the pipette of 233 exist in the sidewall . Moving along a straightaway, a
an analyzer module. This can be accomplished by providing pair of sections 233 on each side of the carrier can help align
a track section integral to the analyzer module, or by the carrier along a pair of straight rails . Beneath concave
providing well -defined bracket locations on the analyzer section 232 , a convex section 234 provides an interface that
module to allow track section modules to be bolted on in a can be used to interact with rails on the outside of the curve .
modular fashion. This allows the pipette to repeatably move It will be appreciated, therefore, that the rails in a curved
relative to an expected position for the bottom of a sample section can have two heights: the rail on the inside of the
tube ( as identified by a model of a sample tube on a typical curve being placed in a higher location to engage concave
carrier, or by the information about the tube and carrier section 232 , while the rail on the outside of the curve is
determined by the TCS ) . With respect to tube top cups , a placed in a lower location to engage convex section 234. In
reliable vertical position is also important. By placing the some embodiments, this relationship is switched , providing
bottom of the carrier at a well -known position and utilizing a concave section lower in the body, while the convex
the characterization information about the tube top cup section is located higher in the body to increase lateral
determined by the TCS , the pipette can reliably interact with stability when going around curves . The exemplary rela
US 2022/0308078 A1 Sep. 29, 2022
23
tionship of concave , flat, and convex portions of the side Clinical Chemistry Analyzer Module
walls 232 , 233 , and 234 may be better understood in the [ 0226 ] One type of analyzer module is the clinical chem
top - down view of FIG . 25 . istry module 34. Clinical chemistry module 34 will be
[ 0220 ] At the base of body 230 , one or more longitudinal explained with respect to a mid -volume clinical chemistry
sliders 236 can be used to minimize friction between body (MVCC ) module. An MVCC module is an instrument for
230 and the stainless steel track . For example, an ultra -high performing automated clinical chemistry testing . The
molecular weight (UHMW ) polyethylene or Teflon material MVCC module can be installed as part of a larger analyzer
may be used. system ( e.g. , analyzer 30 ) , which might include multiple
[ 0221 ] FIG . 24 is a side view of carrier 220. Springs 228 MVCC and IA modules . The MVCC module can also be
supported by member 226 include two sets of leaf springs , connected directly to a laboratory sample distribution track
one set for each sample slot . Upper leaf springs 238 provide via a direct connect LAS interface module .
a longitudinal force to push the top of a tube into tines 222 [ 0227] The primary function of the MVCC module is to
and 224. Meanwhile, lower springs 240 provide a longitu provide clinical chemistry assays using photometric and
dinal force to push the bottom of the tube into tines 222 and integrated multisensory technology (IMT ) or ion selective
224. The combination of these two springs ensures vertical electrode ( ISE ) detectors . An exemplary MVCC module is
alignment of the tube with respect to the vertical alignment capable of processing a maximum of 1200 photometric
of tines 222 and 224 . assays per hour, and up to 600 IMT results per hour (200
samples per hour with up to 3 electrolyte results per sample ).
[ 0222 ] FIG . 25 is a top down view of exemplary carrier The MVCC module includes aa dilution system , an IMT/ISE
220 , showing the relationship of tines 222 , 224 , and springs system , reagent system , and photometric system , and is
228. The right -most and left-most pair ( in the orientation of supported via common base utilities for the MVCC module .
the figure) of tines act to register and center a tube forced by [ 0228 ] In some embodiments, the MVCC module has no
springs 228. Meanwhile , the upper -most and lower -most inherent capability for loading samples, and must be linked
pairs of tines provide additional security to prevent a tube to a source / sink , such as the sample handler module or a
from tipping over in a lateral direction . As can be seen , there direct load track section via the vessel mover system . The
are several openings between the tines and springs. This MVCC module takes one or more sample aliquots from a
allows various optical views of the tube . When the carrier is primary sample vessel that is positioned , via the vessel
placed in the TCS , multiple camera views can be seen mover system , at an aliquot position accessible to a pipette
through the spaces between the tines to read barcode labels of the MVCC module , and stores them onboard for process
or sense the liquid height in the tube. ing .
[ 0223 ] In some embodiments, tines 224 and 222 comprise [ 0229 ] The MVCC module accesses samples from the
a metal - impregnated or carbon -impregnated plastic . Thus, PCM track ( or directly at a single position on the left side ,
these tines can be slightly conductive . The conductivity of in some embodiments ). The MVCC reagent cartridge design
tines can facilitate location sensing by a pipette, and can includes features that permit transfer mechanism interface
affect level sensing of fluids using a capacitive level sense . and automatic cap opening ; this allows it to be " automation
For example , in an exemplary embodiment, the tines or friendly .” This allows the MVCC module to receive reagent
other structures at the top of the carrier are made out of cartridges via the automation track of the vessel mover
approximately 30 % (25 to 35 % ) carbon - filled Lexan resin to system , and automatically move these reagent cartridges
enhance capacitive level sensing during sample aspiration . from the automation track to reagent storage onboard the
In some embodiments, a range between 20 % and 50 % MVCC module . This allows the automatic delivery of
carbon filled Lexan resin can be used . reagents to the MVCC module . In some embodiments , the
[ 0224 ] FIG . 26 illustrates rail engagement between the MVCC module can load and unload reagents to a single
sidewalls of carrier 220 and the side rails of aa curved track position on the PCM track in the back of the module ( e.g. ,
section . In this example, carrier 220 engages a track section position 64 in FIG . 6 ) , or to the manual load station in the
front.
having an inner side rail 242 and an outer side rail 244. Inner [ 0230 ] FIG . 28 is a domain model of MVCC module 300 .
side rail 242 is configured to interface concave section 232 Patient samples, calibrator samples, or control samples
in the sidewall carrier 220. Side rail 242 does not extend all ( together, samples ) 302 are sample tubes delivered via a
the way to the track surface, allowing the corresponding carrier and the vessel mover system to position 56 , where the
convex section below concave section 232 to freely pass sample preparation system 304 can access the sample.
underneath side rail 242. Meanwhile, outer track section Sample preparation system 304 includes a pipette arm that
sidewall 242 engages convex section 234 , and extends accesses a sample access point 56. Preparation system 304
substantially all the way to the track surface. This allows then aspirates one or more aliquots from the sample on the
alignment of the carrier 220 in a curve by providing physical automation track . Based on the identity of that sample, it is
interfaces to guide rails with radiuses substantially the same determined by the MVCC module whether ISE testing or
as those of the guide rails. This minimizes rattling, oscilla photometric testing is appropriate for that sample aliquot. In
tions , lateral impacts, etc., when going around a curve. the case of ISE sample testing , the aliquot is delivered to ISE
[ 0225 ] FIG . 27 illustrates rail engagement between the sample delivery system 306. ISE sample delivery system
sidewalls of carrier 220 and the side rails of a straight track 306 includes a plurality of aliquot vessels , such as cuvettes ,
section . In this example, flat sidewall sections 233 engage to receive the sample aliquot for ISE testing . Delivery
the parallel, flat sidewalls 246 of the track section . This system 306 then delivers the diluted sample aliquot to the
provides four points of interaction between the carrier and ISE testing module that performs a standard ISE test . The
sidewalls, assisting in aligning the carrier in the direction of resulting data of this test is then presented to module control
travel. processor 312. Processor 312 is responsible for scheduling
US 2022/0308078 A1 Sep. 29, 2022
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and managing all testing going on in the MVCC module [ 0235 ] In an exemplary embodiment, the MVCC module
300. Processor 312 receives commands in test orders from is capable of processing a maximum of 1200 photometric
an LIS , or manually from an operator or test menu . Once test assays per hour, and up to 600 IMT results per hour (200
results are completed and presented to the processor, pro samples per hour with up to 3 electrolyte results per sample ).
cessor 312 reports these test results and any other status data , All photometric and IMT assays are processed from diluted
such as completeness of testing for that sample, to the LIS aliquots of the original sample. For photometric assays, the
or a user interface or database . MVCC module prepares one or more dilutions , depending
[ 0231 ] If the sample is determined to need photometric on the dilution ratios of the specific tests for a sample and the
testing , preparation system 304 presents the aliquot to the amount of sample fluid needed .
photometric sample delivery system 308. Photometric [ 0236 ] For IMT assays , an aliquot of the original sample
sample delivery system 308 can include a dilution ring that is delivered to the IMT module, which prepares the dilution
dilutes and stores aliquots of samples. Each photometric internally. For IMT assays, the aliquot of original sample is
sample aliquot is then presented to photometric reaction added to a measured quantity of IMT diluent. The mixture
system 314. This reaction system can include aa reaction ring is drawn through the module past the IMT chip , and the
that receives samples and reagents according to a set time voltage of each of the sensors is read . A measurement of
schedule , and presents those mixed samples to photometer IMT Standard A is taken immediately before or after each
316. Photometer 316 may take multiple photometric mea sample to provide reference readings.
surements of the mixed sample at a regular time interval or [ 0237] Dilutions for photometric assays are stored on a
schedule , to observe the reaction between reagents and the dilution ring until needed by the MVCC test scheduling
diluted sample . Photometer 316 then presents its findings as software. At the appropriate time ( s ) , an aliquot of diluted
photometer data to module control processor 312 . sample is delivered into a reaction cuvette by the sample
[ 0232 ] Reagents can be delivered via aa drawer on the front arm . In general, all photometric assays follow the same
for manual delivery by an operator, or by placing a reagent standard template: the first reagent is delivered into an
vessel at a predetermined location on the automation track , empty reaction cuvette , followed by sample addition and
such as position 64. Reagent delivery system 322 receives mixing. For most photometric assays , a second reagent is
reagents 320 from the reagent drawer or from the automa added to the reaction mixture ( and mixed) 4.3 minutes after
tion track and, using a robot arm or similar mechanical sample addition . Photometric readings are taken at set times
means, reagent delivery system 322 moves that reagent into until the assay is complete (a maximum of 9.75 minutes ).
a reagent storage area 324. In some embodiments , reagent After all the photometric data has been collected , the assay
delivery may require some type of preparation of that result is calculated using one of several available calcula
tions .
reagent by the reagent delivery system 322. Reagent storage [ 0238 ] Photometric dilution ring scheduling operates in
area 324 can be an environmentally / temperature - controlled two basic modes : synchronous and asynchronous. Synchro
storage area , where vessels of reagents are stored to be nous scheduling mode is in operation when the IMT is busy
delivered as reagent aliquots, on demand , to the reaction ring or no IMT work is available. During synchronous operation,
used by the photometric reaction system 314. When a photometric dilutions are being created from samples pre
reagent is needed for a photometric test , an aliquot of that sented to the module . The dilution ring advances every six
reagent can be withdrawn from reagent storage area 324 and seconds , processing dilution cuvettes in sequence . While the
placed into a reagent vessel or cuvettes that are part of the dilution ring is stationary, various operations are performed
reaction ring of photometric reaction system 314 . around the ring, such as creating a new diluted aliquot,
[ 0233 ] MVCC module 300 also receives electricity and washing a dilution cuvette , mixing, etc. In some embodi
water from the laboratory. Water is used for cleaning and ments, each sample is transferred to up to two cuvettes on
rinsing testing components to prevent cross contamination the reaction ring from a single dilution cuvette . To maintain
of samples or reagents. The result of testing and cleaning of synchronization with the reaction ring , two photometric tests
equipment results is liquid waste that must be evacuated by are scheduled for the dilution at the mix station so that, when
the laboratory and treated or flushed . Consumables, such as that dilution reaches the reaction sampling position , the
diluent, cuvettes, or disposable tips or reagent packaging , appropriate cuvettes are ready on the reaction ring. Any
are also presented to MVCC module 300. Once these remaining tests required for the sample being scheduled
consumables are used , they may be disposed of by the ( beyond two) are added to the list of pending work . If the
MVCC module into a solid waste storage area ( e.g. , an particular dilution at the mix station has only one test
internal trash bin ), along with any empty reagent cartridges. requested, the second scheduled test is a generic CLEAN
Once full, an operator can be alerted to empty the solid waste test .
bin and dispose of the contents appropriately ( such as by [ 0239 ] Asynchronous scheduling mode is in operation
placing them in the laboratory trash or bio hazardous waste when the IMT is idle and has work available, or when the
bin) . photometric pending work list gets too long , or when high
[ 0234 ] The MVCC module uses two measurement tech priority ( STAT ) photometric tests are available . During
niques: photometric and Ion Selective Electrode (IMT/ISE ) . asynchronous operation, no new dilutions are created, and
Photometric tests are performed by mixing a sample aliquot no washing or mixing is performed . In asynchronous mode ,
with one or two liquid reagents, and measuring light trans the dilution ring is able to move freely, as needed , in order
mitted through the reaction mixture at one or more wave to make the highest priority photometric test available for
lengths over a period of time,up to 10 minutes. IMT tests are processing
performed by mixing a sample aliquot with IMT diluent, and [ 0240 ] FIG . 29 shows the hardware systems in an exem
passing the mixture past electrodes specific to the target ions plary MVCC module 300. Samples are moved to sample
( e.g. , Na , K , and Cl ) . access point 56 via the vessel mover system . Once pre
US 2022/0308078 A1 Sep. 29, 2022
25
sented, a sample may be aspirated via dilution arm 330 . In some embodiments, reaction ring 340 can include a
Dilution arm 330 is aa robotic arm with a pipette configured plurality of concentric rings having cuvettes with samples
to aspirate an aliquot of a sample. If that sample aliquot is and reagents. These rings can be moved relative to one
designated by the control processor of module 300 for an another to allow reagents to be aspirated and dispensed into
ISE test , dilution arm 330 swings counterclockwise to reaction vessels containing samples. In some embodiments,
position the pipette above an access port for IMT system a single ring is used . Reagents can be added before the
332. If the sample aliquot aspirated by dilution arm 330 is sample arrives, or after the sample arrives via reagent arm
designated for photometric testing, dilution arm 330 rotates 342 or reagent arm 344 .
clockwise to position the pipette above dilution ring 334 . [ 0248 ] The primary function of reagent arms 342 and 344
[ 0241 ] A diluter system includes dilution arm and probe is to move aliquots of reagents from reagent server 346 or
330 , dilution ring 334 , dilution mixer 336 , and a dilution reagent server 345 , respectively. These aliquots are then
aliquot washer, along with support pumps and bulk fluid dispensed into reaction vessels in reaction ring 340. In some
feed systems . The diluter system services the photometric embodiments, the vessel receiving aliquot contains a patient
system and the IMT System . The dilution arm 330 transfers sample; in some embodiments, the vessel is empty and the
the sample from the sample access point 56 on the PCM patient sample will be added later. Reagent servers 345 and
track to either the IMT System 332 , or the dilution ring 334 . 346 include a variety of different reagents, allowing a variety
[ 0242 ] For photometric assays , the dilution arm creates the of tests to be performed by MVCC module 300. Reaction
necessary sample dilution ( s) using saline solution . The nor ring 340 moves vessels in a predetermined sequence such
mal dilution is 1 : 5 , but other dilutions are available , depend that each reaction vessel reaches reagent mixer 348 or
ing upon assay requirements. An exemplary system also has sample mixer 350 for mixing . Reagent mixer 348 can be
the capability to perform serial dilutions ( impacting through used to premix reagents from reagent servers 345 and 346 ,
put) at ratios up to 1 : 2500 . The diluted sample is held for or combination reagents. Sample mixer 350 is used to mix
retest or reflexive testing on dilution ring 334 , until that reaction vessels containing both reagent and sample. Once
aliquot reaches the aliquot wash station . Under normal mixed, the reaction between the sample and reagent pro
(number of tests /sample ) circumstances , the sample is avail ceeds in the reaction vessel . Reaction ring 340 rotates to
able for greater than 10 minutes . allow photometer 352 to take photometric measurements of
[ 0243 ] For the IMT assays , dilution arm 330 performs the reaction at predetermined times . In some tests , additional
serum and / or urine dilutions directly into the IMT port, reagents need to be added by reagent arms 342 and 344 at
where the dilution is mixed . In this case , the IMT specific a predetermined time , the new solution mixed , and addi
diluent is delivered by a separate metering system . tional photometric measurements taken .
[ 0244 ] IMT system 332 is responsible for testing a diluted [ 0249 ] In some embodiments, the photometric system
sample using an appropriate electrode for the ISE test . Once processes the photometric assays in 221 optical cuvettes on
the sample aliquot has been tested , IMT system 332 can then reaction ring 340. The system supports the traditional fixed
flush and clean the internal vessel used to test that sample assay templates used in other MVCC modules in the art.
portion . The results of the IMT testing are then sent to Reaction ring 340 indexes 75 cuvette positions every three
module control processor 312. IMT system 332 includes ISE seconds . Using this indexing pattern , a given cuvette
module 310 from FIG . 28 . advances four cuvette positions every third index . The
[ 0245 ] IMT system 332 processes sample ( serum or urine) system can initiate a new photometric test every three
delivered to the IMT port by dilution arm 330. IMT diluent seconds , yielding a nominal throughput of 1200 assays per
is metered into the entry ort where it is mixed with the hour.
sample. The diluted sample is drawn into the detection [ 0250 ] Assay resources include reagent - 1 delivery, sample
electrode “ stack , " where the concentration of the target ions delivery, reagent mix - 1 , reagent- 2 delivery, and reagent
(Na , K , Cl ) is measured . Reference fluid ( s) can be automati mix - 2 , all at fixed points in time . The reactions are con
cally pumped into the “ stack ” to perform periodic calibra ducted in semi-permanent cuvettes that are washed and
tions . This system operates on an 18 second cycle to process re -used after each assay by a cuvette washer. Assays are
200 samples per hour for a nominal throughput of 600 assays processed in reaction cuvettes held at constant temperature
per hour. (37 ° C. ) on reaction ring 340 through the use of a heated
[ 0246 ] Dilution ring 334 includes aa series of disposable or fluid bath . The system processes assays on a three - second
cleanable vessels / cuvettes. Once dilution ring 334 has cycle .
received a sample aliquot, that ring rotates the cuvettes until [ 0251 ] The assay is initiated with an addition of the first
each cuvette having a sample reaches the dilution mixer 336 reagent ( R1 ) by reagent arm 344. Shortly thereafter, a
to perform a final mix of the diluted sample, making the precision sampler (e.g. , sample arm 338 ) transfers sample
sample suitable for photometric testing . Dilution ring 334 from an aliquot on the dilution ring 334 to the reaction
continues rotating clockwise until that sample is in a posi cuvette . The contents are then mixed thoroughly with
tion that can be accessed by sample arm 338. It should be reagent mixer 348 or sample mixer 350 , and a reaction
appreciated that dilution ring 334 can act as a random - access ensues . The reaction cuvette is read by photometer 352
sample ring , allowing STAT samples to be moved directly approximately once every nine seconds while reaction ring
from the interaction point with dilution arm 330 dilution 340 is indexing. The photometer 352 employs aa standard set
mixer 336 , and then to a position accessible to sample arm of 11 wavelengths currently used by similar photometers in
338 . the art. Photometer 352 supports absorbance and turbidime
[ 0247] Sample arm 338 is responsible for aspirating the tric assays using the 11 available wavelengths.
diluted sample portion prepared by dilution mixer 336 , [ 0252 ] Some assays only require a single reagent, while
moving above a reaction ring 340 , and dispensing that others require a second reagent addition . The second reagent
sample portion into a reaction cuvette in that reaction ring. is added by reagent arm 342 at a fixed point in time ( e.g. ,
US 2022/0308078 A1 Sep. 29, 2022
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approximately 260 seconds after sample addition ), and the stability by only opening each well , as needed . FIG . 30
reaction is mixed by reagent mixer 348 or sample mixer 350 . shows a perspective view of an exemplary dual-well reagent
The reaction is read by the photometer, as before . cartridge.
[ 0253 ] Reagent servers 346 and 345 contain a series of [ 0258 ] The reagent cartridge is closed with a screw - on cap
radially oriented reagent vessels placed in two concentric that can be opened either by the customer (in the case of the
rings . These reagent vessels can be loaded via reagent loader need for pre -hydrating the reagent), or automatically by the
354. Reagent loader 354 includes a robot arm that moves on system . This cap should maintain aa hermetic seal for long
a gantry that allows it to be positioned above the vessel term storage , but be easily opened in use . This closure
mover access point 64 on the automation track . The system is auto - open only, with no provision to re - seal the
mechanical components of the reagent loader 354 can be opened cap . A foil seal is designed for piercing by reagent
substantially the same as those discussed with respect to loader 354 .
robot arm 20 , configured to interact with reagent cartridges. Immunoassay Analyzer Module
When a reagent within reagent server 345 or 346 needs to be
refilled , the servers will automatically eject the empty car [ 0259 ] IA analyzer module 32 is a clinical analyzer that
tridge, and the vessel mover system will retrieve a replace automates heterogeneous immunoassays using magnetic
ment reagent cartridge and position that cartridge via a separation and chemiluminescence readout . Immunoassays
carrier at the vessel mover access point 64. Reagent loader take advantage of the existence of either specific antibodies
354 will then move to that position, and pick up the reagent for the analytes being tested , or specific antigens for the
cartridge using end effectors. Reagent loader 354 will then antibodies being tested . Such antibodies will bond with the
move that reagent cartridge to the appropriate empty slot in analyte in the patient's sample to form an “ immune com
reagent server 345 or 346 , and insert the cartridge into that plex .” In order to use antibodies in immunoassays, they are
location in the reagent server . modified in specific ways to suit the needs of the assay. In
[ 0254 ] Alternatively, an operator can manually load heterogeneous immunoassays, one antibody ( capture anti
reagents at the request of the machine or at a predetermined body) is bound to a solid phase, a fine suspension of
schedule . The operator can load a series of reagent cartridges magnetic particles for the IA module , to allow separation
into a tray at reagent manual load station 356. Reagent using a magnetic field followed by a wash process . This is
manual load station 356 includes a linear slide that receives exemplified in sandwich assays and competitive assays . An
the tray and moves the tray into position underneath reagent exemplary IA module menu can include additional varia
loader 354. End effectors of the robot arm of the reagent tions on these formats .
loader can then remove reagent cartridges from the tray [ 0260 ] In the sandwich assay format, two antibodies are
placed at the reagent manual load station 356 and move used , each one selected to bind to aa different binding site on
those cartridges into the appropriate slot in the reagent the analyte's molecule , which is usually a protein . One
servers . This allows automatic or manual loading of antibody is conjugated to the magnetic particles. The other
reagents . antibody is conjugated to an acridinium ester (AE ) mol
[ 0255 ] Reagents are stored and provided by the reagent ecule . During the assay, sample and the two modified
system . The reagent system includes two refrigerated rotary antibody reagents are added to a cuvette . If the analyte is
reagent servers . One server 345 is dedicated solely to the present in the patient's sample , the two modified antibodies
first reagent addition and one 346 to the second reagent will bind and “ sandwich ” the analyte molecule . Then , a
addition . Each server operates on a three - second cycle with magnetic field is applied, which will attract the magnetic
about one second allocated for motion and two seconds particles to the wall of the cuvette, and excess reagents are
allocated for access by the respective reagent arms. Each washed off . The only AE -tagged antibody left in the cuvette
reagent server holds reagent cartridges arranged in two is one that formed an immune complex through the sand
concentric rings . There are 24 cartridges on the inner ring, wich formation with the magnetic particles . Acid solution is
and 46 cartridges on the outer, for aa total cartridge capacity then added to free up the AE into solution , which also
of 70. In some embodiments, up to four positions on each includes hydrogen peroxide needed for the chemilumines
server can be dedicated to cartridges holding special clean cence reaction . A base is then added to cause it to decom
ing fluids, and one position can be held open for loading and pose , emitting light ( see reaction formulas below—-?a variety
unloading logistics . This means , an exemplary system can of AEs are used in various assays , but the fundamental
simultaneously support 65 different onboard assays . chemistry is substantially identical). Light is emitted as a
[ 0256 ] Reagent cartridges are loaded into the servers by flash lasting a few seconds , and is collected and measured in
2
reagent loader 354. Reagent loader 354 presents the reagent a luminometer. The integrated light output is expressed as
cartridge to a barcode reader to confirm the identity of the relative light units ( RLUS ) . This is compared to a standard
cartridge (PCM track load at position 64 ) , or to identify the curve , which is generated by fitting a dose - response curve to
cartridge (reagent manual load station 356 ) . Reagent loader RLU values generated by known standards of the same
354 then places the cartridge in the appropriate server analyte over its clinical range. Sandwich assays produce a
position ( in server 345 or 346 ) . direct dose -response curve , where higher analyte doses
[ 0257] The reagent cartridge is sized for ease of handling correspond to increased RLUS .
by the PCM , and has gripping features to allow pickup using [ 0261 ] The competitive assay format applies to molecules
reagent loader 354 and a PCM reagent handler ( e.g. , robot for which only one antibody is used . This antibody is
arm 20 ) . The cartridge is closed with a screw - on cap with conjugated to the magnetic particles. A second assay reagent
auto -open features . One or more barcoded labels are pro contains the analyte molecule conjugated to the AE . During
vided for identification by the customer and the system . The the assay, the quantities of the reagents are chosen such that
cartridge has dual wells , with 25 ml capacity in each well . the analyte from the patient's sample and the AE -tagged
The dual well configuration can allow for longer onboard analyte compete for a limited amount of the antibody. The
US 2022/0308078 A1 Sep. 29, 2022
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more patient analyte there is , the less AE - tagged analyte will portions from tubes containing patient samples at position
bind to the antibody . After magnetic separation and wash , 52 on the automation track, as explained in FIG . 6. In some
the only source of AE in the cuvette is from AE - tagged embodiments, sample probe 378 can also access an internal
analyte that has been bound to the magnetic particles queue of manually loaded samples that allow an operator to
through the antibody. Acid and base are added , as before, manually load samples in aa six tube tray. An internal barcode
and the dose analysis is as described for the sandwich assay. reader reads the identity of each of the samples in that tray,
Competitive assays produce an inverse dose - response curve, and that allows sample probe 378 to treat each of the
where a higher signal corresponds to a lower amount of samples in the same manner as it would a sample on the
analyte in the patient sample . automation track . In some embodiments, it is desirable to
[ 0262 ] The IA analyzer module magnetic particle reagent use disposable tips for a sample probe 378. This greatly
is also referred to as the “ solid phase,” and the AE - tagged reduces the risk of carryover between samples. Disposable
reagent is referred to as the “ lite reagent." The IA analyzer tip loader 380 includes a tip triple pack loader, a tip tray
module provides the hardware and software to enable run singulator , a presentation mechanism , and chute to solid
ning multiple assays of various formats, concurrently, in waste . Disposable tip loader 380 is responsible for taking a
random - access and with high throughput. pack of sterile disposable tips , for presenting the tips at a
[ 0263 ] FIG . 31 is a top - down view of the exemplary location accessible to sample probe 378 , for removing any
electromechanical components of an exemplary IA analyzer existing dirty tips from that sample probe , and for placing
module 360 , which includes the following subsystems . that tip with a fresh sterile tip , to allow the sample probe to
[ 0264 ] Analytical Engine - Incubation rings 362 include make the next aspiration .
inner and outer incubation rings , drive mechanisms, cuvette [ 0267] Chassis , Covers , Utilities — These systems are sup
elevators to and from the wash ring , and thermal control. ported by a chassis and other auxiliary hardware . This
These rings facilitate a reaction of sample and reagents hardware includes a chassis frame that includes internal
under controlled temperature for a predetermined time . A walls , baffles, fans, etc. On top of the electromechanical
wash ring 364 includes a ring , a cuvette engaging mecha systems shown in FIG . 31 , a cover of fixed panels and user
nism , and a cuvette elevator to a luminometer. Wash ring 364 accessible doors and drawers, etc. protects these mecha
is responsible for moving samples to a washing station for nisms . External controls and indicators, such as power
washing incubated reacted samples, and moving the result switches and status lights, provide a low - level interface for
ing sample to the luminometer for measurements of the an operator. Hydraulics , such as vacuum subsystems, con
result . A wash station 366 accessible to wash ring 364 densation drains, water and waste plumbing, etc. can be
includes four aspiration probes and Z motion mechanisms, provided . Bulk reagents, such as acids , bases , wash bottles ,
aspiration valves , exterior aspiration probe cleaning ports and supply lines , can be provided in the chassis beneath the
2
and valves , wash dispense pumps, an acid dispense pump , above -discussed mechanisms. Power, data distribution , etc.,
and valves and ports . Luminometer 368 includes an enclo as well as electrical control electronics and processors, can
sure / turntable and drive mechanism , a photomultiplier tube also be provided as part of the chassis.
( PMT) , a base dispense pump, a valve and probe, waste [ 0268 ] A typical test starts in a cuvette in the outer
aspiration hydraulics, and a cuvette ejection mechanism to incubation ring . A sample is added first by the sample probe
dispose of cuvettes after a reaction is measured . Luminom aspirating from the sample delivered via the system by way
eter 368 is responsible for initiating a base reaction for the of the PCM , or direct load by an operator. One , two , or three
treated sample, and measuring the resulting luminance . reagents are added by the reagent probes at specific time
Cuvette loader 370 includes a hopper, an escalator, an intervals after the sample addition, as specified by the test
orientation chute, a drop chute , a pusher, a queue , and a ring definition ( TDef ). The sample and reagents are incubated in
feeding mechanism . The cuvette loader is responsible for the incubation ring . At a specific time , as prescribed by the
loading sterile cuvettes into the incubation rings 362 . TDef, the cuvette is elevated to the wash ring and a wash
[ 0265 ] Reagent /Ancillary Handling —Reagent compart process is performed, which consists of attracting the mag
ment 372 includes a rotary tray, drive and thermal control, netic particles to the cuvette wall and repeatedly aspirating
fans, a barcode reader for identifying reagents , a manual the contents and washing the particles. Up to four aspirations
access door for accepting manually loaded reagent car and seven washes can be carried out in any one trip through
tridges, and an autoloader access door for accepting auto the wash ring . The last aspiration is not followed by a wash .
loaded reagents. The reagent compartment is responsible for If this is a single -pass assay, acid is added and the cuvette is
storing reagents in a refrigerated or thermally -controlled lifted into the luminometer, where the base is added and the
state for access by reagent probes. Reagent autoloader 374 light flash is read . If this is a two -pass assay, at the end of
includes an X - Z mechanism , a pack gripper mechanism , and the wash step the particles are resuspended by a jet of wash ,
pack sensors . The reagent autoloader works substantially and the cuvette is brought down into the inner incubation
similarly to the reagent loader 354 of the MVCC module . ring, where one or two additional reagents are dispensed by
Reagent probes include three probes , each having an X - Z the reagent probes. After an appropriate incubation, the
mechanism , three diluter pumps, fluid volume checking cuvette is elevated again into the wash ring for aa second and
components, a probe wash station , and related hydraulics. final wash, followed by acid addition , base addition , and
Three reagent probes 376 are responsible for aspirating light is read at the luminometer. In the luminometer, after a
reagents and dispensing them into cuvettes in the incubation cuvette has finished the read operation, its contents are
ring. aspirated into the liquid waste , and the cuvette is discarded
[ 0266 ] Sample Handling Sample probe 378 includes a into the solid waste . A cuvette loading mechanism replen
theta - Z mechanism , a diluter pump and syringe, a sample ishes the incubation ring with fresh cuvettes for continuous
integrity sensor, and liquid level sensing components . operation. These are taken from a hopper filled by the user
Sample probe 378 is responsible for aspirating sample periodically.
US 2022/0308078 A1 Sep. 29, 2022
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[ 0269 ] In some embodiments, samples can be a patient's sensors , switch inputs, digital or analog I/O , etc. Luminom
specimen, calibrators used to adjust the standard curve to a eter data and control can also be handled by an exemplary
particular lot of reagents, or controls that are known con node .
centrations of the analyte used to monitor the system per [ 0274 ] The analytical engine of the IA analyzer module is
formance at various intervals over time . In some embodi where all assay processing occurs . This includes the incu
ments, a sample is added to a cuvette in the outer incubation bation rings , wash ring , wash station luminometer, and
ring , and a diluent is then added from aa diluent container in cuvette supply. The analytical engine includes the inner and
the reagent tray using the reagent probes to achieve a desired outer incubation rings ( first pass ring and second pass ring) ,
dilution ratio . The sample probe then aspirates some of the thermal control for incubation rings, wash ring, elevators
diluted sample into a fresh cuvette. In some embodiments, a between incubation rings and wash ring, wash station ( in
few empty cuvettes can be maintained in the outer ring for cluding magnets , aspiration probes, ports , pumps , and
use by STAT samples. valves ) , luminometer, cuvettes loader, and control electron
[ 0270 ] In some embodiments, the machine cycle of an IA ics . This provides assay flexibility in terms of length of
analyzer module is 8 seconds , which translates to a maxi incubations, number of reagent additions, and number of
mum throughput of 450 tests /hr. As mentioned above, each washes and passes . The reaction area is divided between an
cycle allows for one sample addition , three reagent addi incubation area , served by two independently movable incu
tions , two wash actions per wash station , and two luminom bation rings , one for each assay pass , and a separate wash
eter reads . All activities in the system are synchronized so ring that includes the wash station . Each of the incubation
that, for example , a reagent tray is stopped when a reagent rings has intersection points with the wash ring where
probe is aspirating from a pack, or the incubation ring is elevators allow a cuvette to be exchanged between the two.
stopped during a sample dispense. At the heart of the The first -pass ring (outer ring) has one such elevator that
analytical process are the incubation rings and the wash ring. only moves cuvettes up . The second -pass ring has two
The incubation rings have five stops each, with three of them elevators , one going up and one going down , which allow a
dedicated to reagent delivery and the other two for sample cuvette to be brought down from the wash ring into the
addition and cuvette exchange between the incubation and second -pass ring at the end of the first wash in a two -pass
wash rings. The incubation rings move randomly to bring assay, receive additional reagents, incubate there as long as
cuvettes to the various services while the wash ring incre necessary, and then be brought up to the wash ring again for
ments steadily . In some embodiments, the wash ring and the final wash and read .
luminometer operate on a four - second cycle , so that a single [ 0275 ] In an exemplary embodiment, the incubation rings
wash station and luminometer can service first -pass and are temperature - controlled at 37 ° C .; the wash ring is at
second -pass wash / read operations, concurrently. ambient temperature . In some embodiments, cuvettes are
[ 0271 ] Exemplary embodiments of an IA analyzer module asymmetric. Cuvettes need to be placed in the wash ring
can include the following electrical hardware or software with the wide side facing its circumference due to its
modules that can operate on a processor that manages the reduced radius . Incubation and wash rings intersect roughly
operation of an IA analyzer module . The module manager is at right angles and cuvettes are positioned in the incubation
a subsystem of the instruments workstation that supports rings with their narrow side facing the circumference of the
Ethernet ( 10/100/1000 Mbs ), RS232 , USB ( 2.0 ) , and video ring. Elevators for exchanging cuvettes between these rings,
port interfaces as the communication buses with the instru therefore, should account for the orientation of cuvettes .
ment workstation and module device manager. An exem [ 0276 ] The incubation rings make variable circumferential
plary module manager operates on an Intel -based PC , and is moves , while the wash ring increments steadily during the
responsible for diagnostics, software management, user run . In an exemplary embodiment, the wash ring operates on
interface , and configuring any device managers in the instru a cycle time of four seconds , while the incubation rings
ment. operate on the regular machine cycle time of eight seconds .
[ 0272 ] The device manager is the real - time control module The relative positioning of the rings enables cuvettes from
the first pass ring to be elevated into odd positions of the
that supports Ethernet ( 10/100 Base - T ) , CANOpen , RS232 , wash ring, while cuvettes from the second -pass rings are
and USB (2.0 ) interfaces as the communication buses with elevated into even positions of the wash ring. This allows for
the module manager and other device control managers interleaving cuvettes coming from the two rings at the same
( DCM) . The device manager provides distributed vs. cen time and for processing them without negatively affecting
tralized control of the instrument subsystems . Workflow the throughput. This is equivalent to having a dedicated
scheduling and coordination is handled by this embedded wash station for each assay pass . A cuvette that has gone
processor, while individual control of subsystem mechanism through the wash will either be pushed into the luminometer
is handled locally by nodes that are part of each subsystem . for a read, or be pushed down into the second -pass incuba
An exemplary device manager hosts workflow management, tion ring.
scheduler, and sequencers software modules . The device [ 0277] An exemplary embodiment of aa wash station ser
manager also provides appropriate interfaces for external vicing the wash ring includes a set of fixed magnets that
peripherals, command and control, and facilitates gathering draw the particles to the side of the cuvette. While magnetic
status information for all nodes in the IA analyzer module. particles are fixed to the side of cuvettes via magnetic forces,
[ 0273 ] Exemplary device control managers (DCM ) con aspiration probes descend into the bottom of the cuvettes
trol local electromagnetic assemblies within a subsystem . and aspirate their contents . The probes move inside cleaning
The device manager communicates with DCMs to manage collars that inject and aspirate water around the exterior of
these nodes via a CAN bus . Exemplary nodes that can be the probe, to minimize carryover between cuvettes . Wash or
controlled by a DCM include stepper motors and thermal re -suspension solutions are injected from ports mounted at
control hardware . These nodes can also be responsible for an angle and aimed at the particle pellet . To facilitate
US 2022/0308078 A1 Sep. 29, 2022
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multiple washes of the magnetic particles, a series of four Barcode reader, as part of the analyzer module , can identify
individual aspiration probes can be used , such that each patient samples and handle the samples in the same manner
cuvette interacts with each aspiration probe as a wash ring as if that sample arrived via a carrier on the automation
moves . The last probe leaves the cuvette dry. The ring then track . Probe hydraulics can use any conventional means
moves the cuvette away from the magnet’s influence . suitable for an aspirating probe in an IVD environment.
[ 0278 ] If this is a single -pass assay, or the second pass of Pneumatic pumps can utilize air to clear out the sample
a two -pass assay, acid is injected from the acid port. The probe and to regulate pressure to perform an aspiration or
cuvette will then be lifted from the wash ring into the dispensing operation.
luminometer. If this is the first pass of a two - pass assay, a jet [ 0285 ] In some embodiments , an environmental control
of wash will be applied to re - suspend the particles, and the system in a clinical analyzer module is used to precisely
cuvette will move down to the second pass ring at the control the internal temperature of air and onboard fluids in
appropriate elevator position . a clinical analyzer module . Systems and control methods
[ 0279 ] An exemplary luminometer has a single pickup provide for temperature control of aa clinical analyzer mod
position performing a luminosity measurement. A luminom ule , thus resulting in improved test results .
eter includes a light- tight turntable that brings the cuvette in [ 0286 ] According to some embodiments, in - line fluid
front of the photo multiplier tube (PMT ) . Then , a base is heaters are used in conjunction with control of the air
injected to cause the solution to luminesce in a short flash temperature in compartments of aa clinical analyzer module
due to the ensuing chemical reaction . The light is read by the through which the fluidics tubing is routed . This allows the
PMT. The cuvette is then moved to a location where a probe fluid heaters to be mounted at some distance away from the
aspirates its contents to the liquid waste . The cuvette is then point at which the fluid is dispensed, which is otherwise a
ejected into the solid waste . considerable technical challenge . It further eliminates the
[ 0280 ] The cuvette loader serves the first-pass ring only. It need to flush the fluid lines to eliminate cooled liquid that
includes a hopper, escalator, cuvette orientation chute, and has travelled past the fluid heaters in the common situation
an insertion mechanism into the ring. when fluid is not dispensed continuously . Controlling the air
[ 0281 ] In an exemplary embodiment, the incubation rings temperature within the analyzer to a temperature above the
rotate and make a fixed number of stops per cycle . For ambient operating range of the analyzer, according to
example, five stops per cycle may be made , including three embodiments herein , allows temperature to be maintained
stops to facilitate reagent delivery. In the first incubation by heating alone , without the need for expensive cooling
ring, one stop is used at the sample probe to dispense a mechanisms.
sample into one or more cuvettes. The fifth stop is used to [ 0287] According to some embodiments, an environmen
bring the cuvettes to the wash station . In the second incu tal control system for use in a clinical analyzer module
bation ring, the first stop is used to receive a cuvette from the comprises: in - line fluid heat exchangers or heaters to bring
wash ring elevator, while the fifth stop is used to bring the fluids used in the immunoassay reaction to a constant
cuvettes back to the wash ring via the wash ring elevator. temperature; control of the air temperature within the com
The wash ring typically moves in a fixed rate , stopping for partment( s) through which fluid lines are routed ; and control
each wash cycle in each cuvette , and each elevator interac of the air temperature within the compartments in which
tion and luminometer interaction for each cuvette . bulk fluids are stored ( and which house the analyzer elec
[ 0282 ] The reagent handling subsystem of the IA analyzer tronics ). Additional details about this exemplary feature can
module includes a thermal enclosure with an access door, be found in simultaneously filed U.S. Provisional Patent
reagent and drive mechanisms, Peltier-based cooling Application No. 62 /365,307 , which is incorporated herein
systems , barcode readers to identify reagents, an autoloader by reference in its entirety.
an autoloader door, three reagent probes , probe hydraulics, Cuvette and Photometric Improvements of Some
probe wash stations , and control electronics . Embodiments
[ 0283 ] In an exemplary embodiment, reagent and ancillary
packs are intermixed and placed into a rotary tray that allows [ 0288 ] In some embodiments, alignment of reaction
reagent packs to be moved to each position accessible to one cuvette segments on clinical chemistry instruments is
of the three reagent probes. This rotary action can act to
continuously mix reagents so they are ready to be aspirated .
accomplished via visual marking on the cuvette window to
verify the position of a light beam used in performing
This can illuminate pre -mixing steps by an operator. This photometric measurements of samples in the cuvettes. A
rotary action can be accelerated relative to the expected lamp mounting bracket that indicates the location of the light
rotational speed due to the use of three parallel reagent beam is utilized to hold the light beam gauge in position to
probes. To service all reagent probes , the reagent tray in the provide a marking on the cuvette window .
reagent storage should be capable of up to three rotations per [ 0289 ] For example, a system for providing a visual mark
eight - second cycle to deliver three reagents to the three ing on a cuvette window to verify a light beam position for
positions of three reagent probes. Reagent probes may be performing photometric measurements can include an ana
dedicated to different types of reagents to minimize cross lyzer reaction ring that includes one or more reaction cuvette
contamination . segments and a gauge vertical reaction ring. The reaction
[ 0284 ] In some embodiments, the sample probe utilizes cuvette segments each hold one or more cuvettes, and the
disposable tips to minimize cross contamination of samples gauge vertical includes openings at positions corresponding
having different analyte concentrations. Samples can arrive to window positions associated with the cuvettes. The sys
at the sample probe in a sample tube or a tube top cup . tem can also include a gauge light beam that is configured
Calibrators may also be handled by the sample probe in the to be inserted into the openings and rotated against the
same manner. In some embodiments, a direct channel can be cuvettes to hold a light beam area for performing photomet
used to manually load six - position trays of barcode samples. ric measurements on contents of the cuvettes . In some
US 2022/0308078 A1 Sep. 29, 2022
30
embodiments , the aforementioned system further includes a of photometer measurements above the threshold value ; and
bracket light source photo configured to hold the gauge light identifying a falling edge based on detection of a third
beam at a height corresponding to the window positions predetermined number of photometer measurements below
associated with the cuvettes . The gauge light beam may be the threshold value . Once these values are identified, the
held in the bracket light source photo using an aperture rising edge and the falling edge are recorded as being
photometer, and a ring lock aperture may be used to secure indicative of one of the plurality of gaps. This edge detection
the aperture photometer within the bracket light source process may be repeated until a predetermined number of
photo . In some embodiments, the aperture photometer is an gaps are determined.
aperture 1.5 mm photometer. Additional details about this [ 0295 ] In some embodiments, following identification of
exemplary feature can be found in simultaneously filed U.S. the vessel interior, if the rising edge is not identified within
Provisional Patent Application No. 62 /365,298 , which is a predetermined number of photometer measurements, a
incorporated herein by reference in its entirety. report is generated indicating a missing edge . In other
[ 0290 ] In some embodiments, the reduction or elimination embodiments, following identification of the rising edge, if
of drift in a photometer's source lamp can be accomplished the falling edge is not identified within a predetermined
using reference measurement acquired based on a map of number of photometer measurements, a report is generated
cuvette locations . Cuvette mapping can be performed as an indicating a missing vessel.
automatic alignment routine for each cuvette in the system . [ 0296 ] In some embodiments, following the edge detec
The mapping is used to identify locations for acquiring tion process , a plurality of trigger points are computed for
reference measurements which , in turn , may be used to the plurality of vessels based on the recorded gaps . In other
calibrate the photometer and eliminate the effect of source embodiments, following the edge detection process , a vessel
lamp intensity drift. flagging process is performed that includes flagging one or
[ 0291 ] For example, a computer- implemented method for more vessels as unusable for testing based on the stored
correcting photometer source lamp intensity drift includes gaps. A vessel may be designated as unusable for testing if
generating a cuvette map of aa reaction ring that identifies a at least one of the rising edge and the falling edge of a gap
plurality of cuvette locations , and using the cuvette map to adjacent to the vessel is out of tolerance .
identifying a plurality of regions between the plurality of [ 0297] According to another aspect of the present inven
cuvette locations . A plurality of reference measurements are tion , a computer -implemented method for performing pho
acquired using a photometer, with each reference measure tometric cuvette mapping includes aligning a reaction ring to
ment being acquired in one of the plurality of regions. The a mechanical home position where a light associated with a
source drift of the source lamp's photometer may then be photometer is between two vessels and resetting a photom
corrected based on the plurality of reference measurements . eter encoder to zero . Edge data is then captured with a
[ 0292 ] In some embodiments, the plurality of reference photometer device control manager. The reaction ring is
measurements are acquired while acquiring a plurality of rotated past one rotation, and the edge data is read from the
signal measurements corresponding to the plurality of photometer device control manager. The reaction ring is
cuvette locations . The reference measurements and the sig re -aligned to the mechanical home position , and trigger
nal measurements may be oversampled to eliminate noise points are computed from the edge data using the photom
and increase precision . Additionally, in some embodiments, eter device control manager. Indexing may then be initial
the variance of the signal measurements may be used to filter ized to collect photometric measurements from the vessels .
the reference measurements prior to correcting the intensity Additional details about this exemplary feature can be found
drift of the source lamp. Additional details about this exem in simultaneously filed U.S. Provisional Patent Application
plary feature can be found in simultaneously filed U.S. No. 62 / 365,287 , which is incorporated herein by reference
Provisional Patent Application No. 62 /365,294 , which is in its entirety.
incorporated herein by reference in its entirety.
[ 0293 ] In some embodiments, cuvette mapping is per Additional Features of a Vessel Mover System of
formed as an automatic alignment routine for each cuvette in Some Embodiments
the system . This mapping routine finds the optimal trigger [ 0298 ] In some embodiments, techniques used by the VM
ing point to generate precise photometric measurement. The system provide, among other things, the ability to measure
routine may be performed as a part of the cuvette ring's and control the time during which a decapped sample is
initialization routine without any performance impact. Any exposed to air. According to some embodiments, sample
new segments added can be aut natically mapped during exposure to air is managed according to a method that begins
reset of the ring mechanism . As an added benefit of the by receiving a sample in a capped container and parking the
techniques described herein, a reference measurement may capped container on a sample handler. Test requests corre
be calculated between the cuvettes for dynamic source lamp sponding to the sample are then received , with each test
referencing, thereby increasing the accuracy of the results . request associated with one or more analytical modules
[ 0294 ] According to some embodiments, a computer included in automated clinical chemistry analyzers. The first
implemented method for performing photometric cuvette analytical module associated with the first test request is
mapping includes, during a complete rotation of a reaction identified . Once the first analytical module is available for
ring, detecting edges associated with a plurality of gaps testing , the capped container is reloaded from the sample
between a plurality of vessels in a reaction ring. Each gap is handler and the container is decapped . Then , a prioritized
determined according to an edge detection process compris delivery of the decapped container to the first analytical
ing the steps of identifying a vessel interior based on module is performed . Following sample aspiration at the
detection of a first predetermined number of photometer first analytical module , the decapped container may be
measurements below a threshold value ; identifying a rising transported to one or more additional analytical modules, or
edge based on detection of a second predetermined number the test requests may be designated as being complete . In
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31
some embodiments, transportation of the decapped con ness of the left side plate and the right side plate are selected
tainer to the first analytical module and the one or more to provide the linear motor housing with a torsional flex of
additional analytical modules is performed using a linear +/-0.25 degrees.
motor system that applies motive force to a carrier holding [ 0302 ] In some embodiments, the linear motor housing
the decapped container. system includes additional components that supplement the
linear motor housing in creating a robust propulsion system
[ 0299 ] In some embodiments of the aforementioned for carrier vehicles. For example, in one embodiment, the
method, if the decapped container is time -critical for expo system further includes guide rails connected adjacent to
sure to air, the decapped container is entered in a processing each of the longitudinal edges of the linear motor housing .
queue of the first analytical module ahead of one or more In other embodiments, the system includes a plurality of
other samples awaiting testing . Conversely, if the decapped coupling components operable to couple the linear motor
container is not time-critical for exposure to air, the housing to one or more additional linear motor housings in
decapped container may be entered at the end of the pro a manner that facilitates continuous propulsion of the carrier
cessing queue of the first analytical module . In other vehicle across the rectangular stainless steel top plate of the
embodiments, a timer is initialized upon decapping the linear motor housing and rectangular stainless steel top
capped container. A minimum time threshold associated plates corresponding to the other linear motor housings.
with the first test request may be used in conjunction with Additional details about this exemplary feature can be found
this time to prioritize delivery of the decapped container in in simultaneously filed U.S. Provisional Patent Application
the first analytical module’s processing queue. Additionally, No. 62 / 365,216 , which is incorporated herein by reference
prioritization of the decapped container in the first analytical in its entirety.
module's processing queue may be further based on a [ 0303 ] Some methods and systems for operating a VM
relative stability value associated with the sample ( e.g. , as system take advantage of existing sensors in the automation
determined using a table of reference data ). During the system , and may employ additional sensors , as needed, for
method, if it is determined that the relative stability value of the purpose of diagnosing problems and maintaining the
the sample exceeds a predetermined stability threshold , health of the VM system . Automation systems employ
further testing of the sample may be prevented , or a stability measurement circuitry to check the health of the coils that
flag may be associated with the sample that persists through make up the electromagnets in the track , use Hall Effect
out all further testing of the sample . If the timer reaches a sensors ( HES ) to monitor magnetic field deflection created
predetermined limit , an alert may be sent to an operator, by activated coils , and / or a thermometer /thermocouple to
instructing the operator to seal the decapped container as monitor the temperature of the coil boards to check if the
soon as possible . Additional details about this exemplary operating temperatures are as expected . Existing sensors
feature can be found in simultaneously filed U.S. Provisional provide important information such as current measurement,
Patent Application No. 62 /365,206 , which is incorporated deflected magnetic field , temperature , etc.
herein by reference in its entirety. [ 0304 ] In some embodiments , data collected from these
sensors can be communicated to a local or remote central
[ 0300 ] In some embodiments, a transportation system operations monitoring or maintenance monitoring center .
used by the VM system utilizes a linear motor housing that The data can be reviewed for immediate action and /or
is constructed with smaller dimensions and a reduced mate compiled for statistical and / or trend analysis.
rials cost compared to conventional housings . According to [ 0305 ] Thus, the VM system and the carriers may be used
some embodiments, a system for transporting a carrier to assess , and even predict, the health of the vessel Over
vehicle using linear motors includes aa linear motor housing system or its parts. Via communication from one or more of
shaped to hold one or more linear motors . The linear motor the various components , such as the coil boards, master
housing has a rectangular ( or approximately rectangular ) boards, node controllers, controller modules, host PCT,
stainless steel top plate and extruded aluminum left and right vessel mover manager software , linear motors , Ethernet
side plates . The left side plate is connected adjacent to one switches , sensors , Hall Effect sensors , switching mecha
longitudinal edge of the top plate , while the right side plate nisms , power failover gigabit Ethernet switches , thermom
is connected adjacent to the other longitudinal edge of the eters / thermocouples, humidity sensors , etc. , with a local or
top plate. The top plate is designed to support propulsion of remote monitoring stations (e.g. , computer), the current
the carrier vehicle over its surface . Thus, for example, in one status of the VM system may be assessed in near real -time,
embodiment, the top - facing side of the top plate has a and data can be collected, stored, and analyzed for identi
surface roughness between 0.2 uM and 0.4 uM . fying current or future trends in an effort to predict main
[ 0301 ] In some embodiments , the aforementioned linear tenance events, before they occur. The monitoring , in addi
motor housing includes one or more features that are used to tion to reading an output, such as temperature, can also
ensure efficient operation of the linear motor system . For involve running a test protocol , which can be can be done
example, in one embodiment, the linear motor housing automatically by the master boards on a regular basis , or
further includes electromagnetic shielding material applied upon request by an operator or central software .
to the rectangular stainless steel top plate and the two side [ 0306 ] In some embodiments, the central monitoring sta
plates . In another embodiment, eddy current shielding mate tion may monitor multiple systems at different locations and
rial is applied to the rectangular stainless steel top plate. This potentially different customers simultaneously. In this man
eddy current shielding material may additionally be applied ner, the IVD manufacturer can implement a service plan for
to the side plates . The thickness of the aluminum side plates its customers. Additional details about this exemplary fea
can vary in different embodiments . In some embodiments , ture can be found in simultaneously filed U.S. Provisional
the thickness is minimized to permit flexibility of the linear Patent Application No. 62 / 365,310 , which is incorporated
motor housing. For example, in one embodiment, the thick herein by reference in its entirety .
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[ 0307] In some embodiments, a carrier may have a tem interlocks in order to provide sample chain of custody
perature control system ( e.g. , active or passive temperature without the need to re - identify the sample at points of
control ). For example , the temperature control system may interaction ( aspiration /de -capping / etc . ). This eliminates the
be a passive temperature control, wherein the carrier has a need to have sample identification stations at each interac
payload within an insulation material. Thus, an embodiment tion point. This reduction of hardware allows the system to
could utilize the insulation container to minimize the heat be cheaper, smaller, and more reliable . It also allows not
flow to the vessel and keep it at, or near, its original only the automation system , but also existing pre -analytical/
temperature on its path to a testing station . This allows for analytical equipment connected to the automation system , to
a light, cost effective, and easy to maintain solution . run more efficiently.
[ 0308 ] A further embodiment may utilize active tempera [ 0313] According to some embodiments, there are four
ture control. In case of an active temperature control, the features that facilitate addressing the issue of providing a
carrier, or intelligent carrier, may have a device capable of more consistent, realizable capacity solution :
manipulating its temperature . For example, the carrier may [ 0314 ] 1. A single point for the acquisition of the sample
have a mini thermoelectric device attached to it . Thermo identification ( e.g. , barcode reader ), which pairs a tube's
electric cooling uses the Peltier effect to create a heat flux unique ID to the unique ID of a puck on the automation
between the junctions of two different types of materials. In track ;
a further embodiment, the thermoelectric cooler (TEC ) [ 0315 ] 2. An automation track that is able to continuously
device may be combined with the passive temperature keep track of the identity and position of all of its pucks ;
control discussed herein (e.g. , 240 ) to help keep the payload [ 0316 ] 3. A continuous cover set over all of the areas of
at the desired temperature. travel and destinations for the samples; and
[ 0309 ] Additionally, an embodiment may utilize a mini [ 0317] 4. The ability to detect if any cover has been
electrocaloric cooling device (ECC ) . An electrocaloric breached .
device comprises a material that has aa reversible temperature [ 0318 ] Additional details about this exemplary feature can
change under an applied electric field . The effect comes be found in simultaneously filed U.S. Provisional Patent
from the voltage raising or lowering the entropy of the Application No. 62 /365,268 , which is incorporated herein
system , analogous to the magnetocaloric effect. Similar to by reference in its entirety .
the TEC device, the ECC device may be combined with the [ 0319 ] Although the present invention has been described
passive temperature control discussed herein ( e.g. , 240 ) to with reference to exemplary embodiments, it is not limited
help keep the payload at the desired temperature . Additional thereto . Those skilled in the art will appreciate that numer
details about this exemplary feature can be found in simul ous changes and modifications may be made to the preferred
taneously filed U.S. Provisional Patent Application No. embodiments of the invention and that such changes and
62 /365,276 , which is incorporated herein by reference in its modifications may be made without departing from the true
entirety. spirit of the invention . It is therefore intended that the
[ 0310 ] Some embodiments utilize techniques to align a appended claims be construed to cover all such equivalent
diagnostic instrument of robotic pipetting probes to sample variations as fall within the true spirit and scope of the
tubes on carriers, cuvettes, or reagent packs in indexing invention .
rings . Accordingly, an embodiment provides an ultra -accu What is claimed is :
rate alignment system to ensure proper interaction between 1. An analyzer system for use in an in vitro diagnostics
a probe and a target. The automated alignment system may ( IVD ) environment comprising:
utilize a probe switch and /or a probe runout sensor. Using one or more analyzer modules configured to aspirate a
one or more of these ( i.e. , the probe switch and runout portion of a patient sample from each of a plurality of
sensor ), an embodiment can simplify the process , while still patient samples and perform a clinical analysis of that
achieving a highly accurate and repeatable alignment. patient sample;
[ 0311 ] Specifically, an embodiment of the system may a vessel moving system comprising
insert, using a robotic arm , a hunting tool into an aperture . an automation track comprising a plurality of track
It may then detect, using a plurality of sensing beams, a first sections forming a plurality of branches, and
location of the hunting tool within the aperture . An embodi a plurality of sample carriers configured to accept at
ment may then rotate, using the robotic arm , the hunting tool least one of the plurality of patient samples and a
180 degrees and again detect, using the plurality of sensing plurality of tubes of control and calibrator fluids and
beams , a second location of the hunting tool within the to traverse the automation track under processor
aperture . Based on these two calculations , a runout magni control;
tude and a runout direction may be determined . The hunting a sample handler module comprising
tool may then be inserted into a target via the robotic arm . one or more drawers configured to accept a plurality of
The hunting tool may detect, using a pressure sensitive tip , trays holding the plurality of patient samples,
a location of the hunting tool with respect to the target and , wherein the patient samples are held in tubes, at least
thereafter, an embodiment may adjust the location of the a portion of which are capped,
hunting tool with respect to the aperture and target based on a plurality of cameras that record overhead images of
the above factors. Additional details about this exemplary sample tubes while in the drawers, and
feature can be found in simultaneously filed U.S. Provisional a robot arm configured to move patient sample tubes
Patent Application No. 62 /365,225 , which is incorporated between the drawers and carriers on an automation
herein by reference in its entirety. system ; and
[ 0312 ] In some embodiments, the VM system continu a processor configured to monitor the status of the patient
ously tracks the identity and positions of all of its carriers sample tubes and vessel moving system , to de - cap
with a single sample identification station , and covers / patient samples on demand, to monitor an amount of
US 2022/0308078 A1 Sep. 29, 2022
33
time a patient sample is uncapped prior to routing to an receiving , at a sample handler module having a robot arm ,
analyzer module, and to set a priority of uncapped a plurality of trays holding a plurality of patient sample
samples within the vessel moving system . tubes via one or more drawers located at a front of the
2. The analyzer system of claim 1 , wherein each track sample handler module that is accessible to a human
section has a surface that includes a plurality of synchro operator;
nously controlled magnetic coils , and the processor is fur providing an automation track that propels a plurality of
ther configured to monitor a maintenance status of the sample carriers under processor control along a surface
automation track via thermal and magnetic sensors and to of the automation track ;
report automation track health information over a network . positioning a first sample carrier at a location on the
3. The analyzer system of claim 1 , further comprising a automation track to receive a first patient sample tube
station on the automation track having a plurality of cameras from the robot arm ;
that observe each of the plurality of sample carriers to decapping the first patient sample tube under processor
characterize the carrier and at least one of the plurality of control;
patient sample tubes after that patient sample tube has been positioning , via the first carrier, the first patient sample
placed into the carrier. tube at a second location accessible to a pipette con
4. The analyzer system of claim 1 , wherein each of the trolled by a first analyzer module ;
plurality of track sections receives primary power from one performing, by the first analyzer module, a clinical analy
of the one or more analyzer modules and backup power from sis of at least one of clinical chemistry characteristics
an adjacent one of the one or more analyzer modules. and immunoassay characteristics of a patient sample in
5. The analyzer system of claim 1 , wherein the covered the patient sample tube; and
refrigerated storage further comprises individual evapora monitoring , by the processor, an amount of time a patient
tion covers placed on each control and calibrator fluid . sample tube is uncapped prior to arrival at the first
6. The analyzer system of claim 1 , further comprising a analyzer module.
plurality of reagent carriers configured to accept a reagent 14. The method of claim 13 , further comprising the steps
cartridge and to transport the reagent cartridge, via the of:
automation track , to a location accessible to the one or more capturing a plurality of images of the plurality of patient
analyzer modules. sample tubes, using a plurality of overhead cameras , as
7. The analyzer system of claim 1 , wherein the automation each of the one or more drawers is closed ; and
track is configured such that the plurality of track sections analyzing the plurality of images to determine physical
form an outer loop on the perimeter of the one or more characteristics of each of the plurality of sample tubes .
analyzer modules and a plurality of bypass track sections 15. The method of claim 13 , further comprising the steps
internal to the one or more analyzer modules that bypass the of:
outer loop , and wherein a first location on the automation capturing a plurality of images of the first carrier, using a
track accessible to the at least one pipette is on at least one plurality of cameras after the first carrier has received
of the bypass track sections . the first sample; and
8. The analyzer system of claim 7 , wherein each of the one analyzing the plurality of images to determine an identity
or more analyzer modules is serviced by one of the bypass and physical characteristics of the first sample tube.
track sections and that bypass track section is configured to 16. The method of claim 13 , wherein the step of providing
temporarily hold aa subset of the plurality of sample carriers an automation track comprises providing a plurality of track
for random access by the at least one pipette. sections and further comprising a step of providing primary
9. The analyzer system of claim 8 , wherein movement and power to each track section from one of the one or more
random access of the subset of the plurality of sample analyzer modules and providing backup power from an
carriers on each of the bypass track sections is controlled adjacent one of the one or more analyzer modules in the
responsive to a processor of the one or more analyzer event of an interruption of the primary power.
modules. 17. The method of claim 13 , further comprising the steps
10. The analyzer system of claim 7 , wherein the outer of:
loop is accessible to the sample handler module and wherein placing a plurality of control and calibrator fluids in a
the plurality of track sections form a bypass track section refrigerated storage in the sample handler module; and
configured to allow sample carriers to travel around the storing the plurality of control and calibrator fluids in the
perimeter of the one or more analyzer modules without refrigerated storage for multiple days.
returning to the sample handler module . 18. The method of claim 13 , further comprising the steps
11. The analyzer system of claim 1 , wherein each of the of:
plurality of sample carriers comprises a sample tube holder providing at least one reagent carrier configured to move
having two positions , and wherein the sample handler mod along the automation track ;
ule is configured to place a first one of the plurality of patient transporting a reagent cartridge using the reagent carrier
samples into the sample tube holder before removing a along the automation track to a third location accessible
second one of the plurality of patient samples from the to the first analyzer;
sample tube holder. receiving the reagent cartridge by the first analyzer using
12. The analyzer system of claim 1 , wherein the sample a robot arm of the first analyzer , and
handler module includes a covered refrigerated storage storing the reagent cartridge by the first analyzer for use
configured to store a plurality of tubes of control and in the clinical analysis.
calibrator fluids for multiple days without evaporation . 19. The method of claim 13 , wherein the step of providing
13. A method for analyzing patient samples comprising an automation track comprises providing a plurality of track
steps of: sections to form an outer loop on the perimeter of the one or
US 2022/0308078 A1 Sep. 29, 2022
34
more analyzer modules and providing a plurality of bypass

track sections internal to the one or more analyzer modules
that bypass the outer loop , wherein the second location on
the automation track accessible to the pipette is on at least
one of the bypass track sections .
20. The method of claim 13 , further comprising setting a
priority for each uncapped sample as it moves along the
automation track .

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94 Notify Sample 96 Move piperte

more analyzer modules and providing a plurality of bypass

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