U.S. patent application number 15/725152 was filed with the patent office on 2018-05-17 for modular chemistry analyzer.
The applicant listed for this patent is Jeannine Dussi, Steve Rettew, Diana Zipeto. Invention is credited to Jeannine Dussi, Steve Rettew, Diana Zipeto.
Application Number | 20180137398 15/725152 |
Document ID | / |
Family ID | 40566308 |
Filed Date | 2018-05-17 |
United States Patent
Application |
20180137398 |
Kind Code |
A1 |
Rettew; Steve ; et
al. |
May 17, 2018 |
MODULAR CHEMISTRY ANALYZER
Abstract
A chemistry analyzer is disclosed that can include a unitary
base with vertical and horizontal supports for constraining
subassemblies. The subassemblies include at least a reagent/sample
carousel subassembly, a transfer arm subassembly, and a reaction
carousel subassembly. A centralized hydraulic system can also be
provided behind a user access panel. The analyzer can use
machine-readable test specifications coupled with its reagent
vessels to define tests that include operations that employ the
reagents. The analyzer can also display to the operator a pictorial
representation that includes graphical elements that convey levels
of usage for the storage vessels, and access icons that are each
associated with a color and each lead to a set of screens for
different types of operations for the analyzer.
Inventors: |
Rettew; Steve; (Harvard,
MA) ; Zipeto; Diana; (Lowell, MA) ; Dussi;
Jeannine; (Arlington, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Rettew; Steve
Zipeto; Diana
Dussi; Jeannine |
Harvard
Lowell
Arlington |
MA
MA
MA |
US
US
US |
|
|
Family ID: |
40566308 |
Appl. No.: |
15/725152 |
Filed: |
October 4, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13618378 |
Sep 14, 2012 |
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15725152 |
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11985077 |
Nov 13, 2007 |
9047545 |
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13618378 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G01N 2035/00326
20130101; G06F 3/04817 20130101; G01N 35/00722 20130101; G01N 35/10
20130101; Y10T 436/114165 20150115; G06K 19/0723 20130101; G01N
35/025 20130101; Y10T 436/11 20150115 |
International
Class: |
G06K 19/07 20060101
G06K019/07; G06F 3/0481 20130101 G06F003/0481; G01N 35/02 20060101
G01N035/02; G01N 35/00 20060101 G01N035/00; G01N 35/10 20060101
G01N035/10 |
Claims
1-56. (canceled)
57. A method of operating a chemistry analyzer that includes: a
processor and a storage device including instructions configured to
run on the processor, a reagent/sample carousel subassembly for
holding a plurality of reagent vessels and sample vials for holding
samples of different patients, a plurality of different reagent
vessels that each store one or more different reagents for testing
different selected analytes and a plurality of sample vials for
holding patient samples, a reaction carousel subassembly that
defines cuvette locations, a transfer arm subassembly including a
probe for transferring reagents and samples to the cuvette
locations, a probe wash station positioned along an arc of motion
of the transfer arm, a photometer positioned to acquire photometric
measurements from the cuvette locations in the reaction carousel,
and a touch screen, wherein the touch screen is operatively
connected to the processor, comprising: simultaneously displaying
on the touch screen a display area and a series of four access
icons including a worklist icon, a results icon, a status icon, and
a diagnostics, maintenance, and/or set up icon, which are each
associated with a different color and each allow access to
information for different types of operations for the analyzer,
wherein the information is color coded to correspond to the color
associated with their respective access icons, displaying a
worklist menu in response to user actuation on the touch screen of
the worklist icon that is associated with a first color, while
continuing to display the four access icons on the touch screen,
displaying in response to a user selection in the worklist menu one
of a plurality of sub-screens that is color coded according to the
first color in the display area, including a data table sub-screen
that lists tests for the analyzer, while continuing to display the
four access icons on the touch screen, displaying a status menu in
response to user actuation on the touch screen of the status icon
that is associated with a second color, while continuing to display
the four access icons on the touch screen, displaying in response
to a user selection in the status menu one of a plurality of
sub-screens that is color coded according to the second color in
the display area, including a status sub-screen that lists a
plurality of status entries for the analyzer, while continuing to
display the four access icons on the touch screen, displaying a
results menu in response to user actuation on the touch screen of
the results icon that is associated with a third color, while
continuing to display the four access icons on the touch screen,
displaying in response to a user selection in the results menu one
of a plurality of sub-screens that is color coded according to the
third color in the display area, including a results sub-screen
that lists a plurality of results entries for the analyzer, while
continuing to display the four access icons on the touch screen,
displaying a diagnostics, maintenance, and/or setup menu in
response to user actuation on the touch screen of the diagnostics,
maintenance, and/or setup icon that is associated with a fourth
color, while continuing to display the four access icons on the
touch screen, displaying in response to a user selection in the
diagnostics, maintenance, and/or setup menu one of a plurality of
sub-screens that is color coded according to the fourth color in
the display area, including a diagnostics, maintenance, and/or
setup icon entry sub-subscreen for the analyzer, while continuing
to display the four access icons on the touch screen.
58. The method of claim 57 further including the steps of:
determining reagent fill levels associated with the plurality of
reagent vessels that store the reagents for use by the analyzer,
displaying to the operator a pictorial representation that includes
a plurality of graphical elements that convey the fill levels for
the reagent vessels, wherein each graphical element corresponds to
one of the reagent vessels, and wherein the fill levels of the
reagent vessels are each represented by one of a plurality of
different visual fill level representations that each resemble a
different fill level in a corresponding graphical element,
transferring reagents from the reagent vessels to one or more
reaction vessels in the analyzer to perform tests with the
analyzer, updating reagent fill levels associated with the reagent
vessels from which reagents are transferred in the step of
transferring, and updating the graphical elements with new ones of
the graphical fill level representations to reflect the updated
fill levels as reagents are transferred from the vessels to perform
tests with the analyzer.
59. The method of claim 58 wherein the step of displaying a
pictorial representation is performed as part of displaying a
combined worklist screen in the step of responding to user
actuation of a worklist icon.
60. The method of claim 58 wherein the step of displaying a
pictorial representation employs graphical elements that are shaped
like the vessels provided in the step of providing a plurality of
different reagent vessels that each store one or more different
reagents for use by the analyzer.
61. The method of claim 60 wherein the graphical fill level
representations that cover different amounts of area are each
shaded areas in the vessel-shaped graphical elements.
62. The method of claim 58 further including the step of
identifying the contents of a plurality of vessels that store
samples for use by the analyzer, and the step of displaying to the
operator a pictorial representation that includes a plurality of
elements that identify the contents of the vessels.
63. The method of claim 62 wherein the pictorial representation of
the reagent vessels and the sample vessels are part of a combined
representation.
64. The method of claim 62 wherein the step of displaying the
worklist icon displays a first pictorial representation in the
worklist icon, wherein the step of displaying the status icon
displays a second pictorial representation in the status icon,
wherein the step of displaying the results icon displays a third
pictorial representation in the results icon, wherein the step of
displaying the diagnostics, maintenance, and/or set up icon
displays a fourth pictorial representation in the diagnostics,
maintenance, and/or set up icon, wherein the first, second, third,
and fourth icons are all different.
65. The method of claim 58 wherein the pictorial representation is
a mapped pictorial representation in which positions of the
graphical elements on the display correspond to positions of the
vessels in the analyzer.
66. The method of claim 65 wherein the step of displaying a
pictorial representation employs graphical elements that are shaped
like the vessels provided in the step of providing a plurality of
different reagent vessels that each store one or more different
reagents for use by the analyzer.
67. The method of claim 66 wherein the graphical fill level
representations that cover different amounts of area are each
shaded areas in the vessel-shaped graphical elements.
68. The method of claim 58 wherein the pictorial representation
employs colored bars having different areas to convey the fill
levels.
69. The method of claim 58 wherein the pictorial representation
includes elements that identify the reagents in the reagent
vessels.
70. The method of claim 57 wherein the step of displaying the
worklist icon displays a first pictorial representation in the
worklist icon, wherein the step of displaying the status icon
displays a second pictorial representation in the status icon,
wherein the step of displaying the results icon displays a third
pictorial representation in the results icon, wherein the step of
displaying the diagnostics, maintenance, and/or set up icon
displays a fourth pictorial representation in the diagnostics,
maintenance, and/or set up icon, wherein the first, second, third,
and fourth icons are all different.
71. A chemistry analyzer, including: a reagent/sample carousel
subassembly for holding a plurality of sample vials for samples of
different patients and for holding a plurality reagent vessels that
each store one or more different reagents for testing different
selected analytes in blood, a reaction carousel subassembly that
defines cuvette locations, a transfer arm subassembly including a
probe for transferring reagents and samples to the cuvette
locations, a probe wash station positioned along an arc of motion
of the transfer arm, and a photometer positioned to acquire
photometric measurements from the cuvette locations in the reaction
carousel, a touch screen, a programmed computer operatively
connected to the touch screen and including stored software
operative to simultaneously display on the touch screen a display
area and series of four access icons including a worklist icon, a
results icon, a status icon, and a diagnostics, maintenance, and/or
set up icon, which are each associated with a different color and
each allow access to information for different types of operations
for the analyzer, wherein the information is color coded to
correspond to the color associated with their respective access
icons, wherein the programmed computer is responsive to user
actuation on the touch screen of the worklist icon that is
associated with a first color to display a worklist menu while
continuing to display the four access icons on the touch screen,
and wherein the worklist menu is responsive to a user selection in
the worklist menu to display one of a plurality of sub-screens that
is color coded according to the first color in the display area,
including a data table sub-screen that lists tests for the
analyzer, while continuing to display the four access icons on the
touch screen, wherein the programmed computer is responsive to user
actuation on the touch screen of the status icon that is associated
with a second color to display a status menu while continuing to
display the four access icons on the touch screen, and wherein the
status menu is responsive to a user selection in the status menu to
display one of a plurality of sub-screens that is color coded
according to the second color, including a status sub-screen that
lists a plurality of status entries, while continuing to display
the four access icons on the touch screen, wherein the programmed
computer is responsive to user actuation on the touch screen of the
results icon that is associated with a third color to display a
results menu while continuing to display the four access icons on
the touch screen, and where in the results menu is responsive to a
user selection and the results menu to display one of the plurality
of sub-screens that is color coded according to the third color,
including a results sub-screen that lists a plurality of results
entries, while continuing to display the four access icons on the
touch screen, and wherein the programmed computer is responsive to
user actuation on the touch screen of the diagnostics, maintenance,
and/or setup icon that is associated with a fourth color to display
a diagnostics, maintenance, and/or setup menu while continuing to
display the four access icons on the touch screen, and wherein the
diagnostics, maintenance, and/or setup menu is responsive to user
selection in the diagnostics, maintenance, and/or setup menu to
display one of a plurality of sub-screens that is color coded
according to the fourth color, including a diagnostics,
maintenance, and/or setup icon entry sub-subscreen, while
continuing to display the four access icons on the touch
screen.
72. The apparatus of claim 71 wherein the programmed computer is
operative to display a first pictorial representation in the
worklist icon, wherein the programmed computer is operative to
display a second pictorial representation in the status icon,
wherein the programmed computer is operative to display a third
pictorial representation in the results icon, wherein the
programmed computer is operative to display a fourth pictorial
representation in the diagnostics, maintenance, and/or set up icon,
wherein the first, second, third, and fourth icons are all
different.
Description
FIELD OF THE INVENTION
[0001] This invention pertains to chemistry analyzers for use in
clinical settings.
BACKGROUND OF THE INVENTION
[0002] Chemistry analyzers are very important health care tools.
They can detect imbalances in a number of chemical species in
bodily fluids, such as cholesterol, glucose, enzymes, iron,
magnesium, protein, uric acid, chlorine, lithium, potassium, or
sodium. This information can help to diagnose a variety of
conditions, such as high cholesterol, abnormal liver function, or
diabetes, to name only a few. Improvements to the quality of
measurements performed by chemistry analyzers could therefore have
a positive effect on the care of a very large number of
patients.
[0003] A chemistry analyzer is also a relatively expensive item for
a health care provider, such as a hospital, and this cost is
usually passed on to health care consumers. The cost that is passed
on can be affected by the initial cost of the analyzer, the cost of
reagents and reaction cuvettes, and the cost of maintaining and
servicing the analyzer. Improvements that lead to a reduction in
cost of chemistry analyzers and their maintenance could therefore
have a positive effect on the overall cost of health care. And the
overall health care savings resulting from even a relatively small
reduction in the costs associated with an analyzer could be
substantial in view of the large number of patients served by these
analyzers.
[0004] The cost savings could also help make the technology
available to more patients. In developing countries and remote or
less affluent regions of developed countries, cost may prevent
health care providers from having easy access to a chemistry
analyzer. They might thus need to send samples to remote
facilities, recommend that patients travel to those facilities, or
even diagnose conditions without the benefits of automated chemical
analysis. Improvements that lead to a reduced cost of chemistry
analyzers and their maintenance could therefore have a significant
effect on the availability of health care as well as the promptness
and efficiency with which it can be delivered.
[0005] One common chemistry analyzer design employs two carousels
and a transfer arm equipped with a probe. The first carousel
carries patient samples and reagents, which can be cooled to
maintain stability. The transfer arm and probe move small amounts
of reagents and samples to one of a series of reaction cuvettes
carried by a second, heated carousel. The reaction mixture can then
be subjected to photometric tests or transferred to a module
containing sensors for potentiometric analysis. A fluidic system
provides fluid for sample dilution and for washing the probe and
fluid lines, and an electrical system relays results and provides
power and sequencing signals to the various parts of the analyzer.
Other designs of chemistry analyzers utilize two or more transfer
arms and probes, and two or more carousels for samples and
reagents.
[0006] In existing chemistry analyzers, various parts of the
analyzer are typically mounted to a metal chassis. Wires, cables,
and supply and waste tubes are connected between the mounted parts,
and covers surround and protect the assembled analyzer.
SUMMARY OF THE INVENTION
[0007] In one general aspect, the invention features a chemistry
analyzer that includes a unitary base, for mounting a plurality of
subassemblies that include at least a reagent/sample carousel
subassembly, a transfer arm subassembly, and a reaction carousel
subassembly. The base has vertical supports including at least one
support for each subassembly, with each vertical support
constraining its subassembly in the horizontal direction. It also
has horizontal supports including at least three supports for each
subassembly, with each horizontal support constraining its
subassembly in the vertical direction.
[0008] In preferred embodiments, the horizontal supports can be
each defined by a single boss. A plurality of the horizontal
supports for at least one of the subassemblies can be provided by a
single support surface. The vertical supports can be each defined
by a single pin. The base can include two vertical supports for at
least one of the subassemblies to constrain rotation of that
subassembly. The base portions can include at least a paired boss
and pin for each of the subassemblies, with the paired boss being
positioned to protrude above the paired pin. At least two pins can
define vertical supports for the reagent/sample carousel
subassembly, at least two pins can define vertical supports for the
reaction area subassembly, and at least one pin can define the
vertical support for the transfer arm subassembly. The base can
comprise a single molded base part with the horizontal supports
being machined horizontal areas of the single molded base part. The
analyzer can further include at least a further vertical support
and a further horizontal support for a wash station subassembly.
The analyzer can further include at least a further vertical
support and a further horizontal support for a photometer
subassembly. The horizontal and vertical supports can fully
constrain each of the subassemblies independent of any fastening
mechanism.
[0009] In another general aspect, the invention features a method
for a chemistry analyzer that includes horizontally constraining
each of a plurality of chemistry analyzer subassemblies with
horizontal supports defined by an integral base, and vertically
constraining each of the plurality of chemistry analyzer
subassemblies with at least one vertical support defined by the
integral base.
[0010] In a further general aspect, the invention features an
integral base means that define a plurality of horizontal chemistry
analyzer subassembly constraining means for each of a plurality of
chemistry analyzer subassemblies, and at least one vertical
chemistry analyzer subassembly constraining means for each of the
plurality of chemistry analyzer subassemblies.
[0011] In another general aspect, the invention features a
chemistry analyzer that includes a chassis for mounting a plurality
of chemistry analysis sub-assemblies, a housing surrounding the
chemistry analysis sub-assemblies, a user access panel on the
housing, and a centralized hydraulic system area defined to house a
plurality of hydraulic elements operative to handle fluid for the
plurality of subassemblies in the analyzer. These hydraulic
elements are located in the housing and behind the user access
panel.
[0012] In preferred embodiments, the hydraulic system can include
consumable hoses that are replaceable through the access panel. The
system can include circuitry that permits the system to operate
while the access panel is open. The chemistry analyzer can further
include a drawer base that defines the centralized hydraulic system
area, with the user access panel being a drawer front mounted on
the drawer base.
[0013] In a further general aspect, the invention features an
automated chemistry analysis method that includes receiving a
modular chemistry analysis test unit that includes one or more
vessels for one or more reagents, and a machine-readable test
specification coupled with the vessels and defining a test that
defines a test including a series of operations that employ the
reagents for the vessels. The method also includes installing the
chemistry analysis test unit in a first chemistry analyzer that
includes one or more analysis tools and sequencing logic for
sequencing instructions to be carried out by the analysis tools,
and automatically retrieving the machine-readable test
specification from the chemistry analysis test module and storing
it for access by the sequencing logic to allow the sequencing logic
to instruct the analysis tools to carry out the test defined by the
test specification.
[0014] In preferred embodiments, the step of automatically
retrieving can operate independent of any software upgrade for the
analyzer. The machine-readable test specification can be stored in
an RFID tag affixed to the vessel. The vessel is a compound
multi-reagent vessel that can include subvessels for a plurality of
reagents, with the machine-readable test specification including
information defining operations using the plurality of reagents
stored in the subvessels. The step of receiving can receive a
modular chemistry analysis test unit that further includes one or
more machine-readable reagent quantity values, and can further
include the step of storing an updated version of the
machine-readable reagent quantity values after use by the first
chemistry analyzer of one or more reagents from the modular
chemistry analysis test unit. The method can further include the
step of installing the chemistry analysis test unit in a second
chemistry analyzer that includes one or more analysis tools and
sequencing logic for sequencing instructions to be carried out by
the analysis tools, the step of automatically retrieving the
machine-readable test specification from the chemistry analysis
test module and storing it for access by the sequencing logic to
allow the sequencing logic to instruct the analysis tools to carry
out the test defined by the test specification, and the step of
storing an updated version of the machine-readable reagent quantity
values after use by the second chemistry analyzer of one or more
reagents from the modular chemistry analysis test unit. The method
can further include the step of installing the chemistry analysis
test unit in a second chemistry analyzer that includes one or more
analysis tools and sequencing logic for sequencing instructions to
be carried out by the analysis tools, and the step of automatically
retrieving the machine-readable test specification from the
chemistry analysis test module and storing it for access by the
sequencing logic of the second chemistry analyzer to allow the
sequencing logic to instruct the analysis tools to carry out the
test defined by the test specification.
[0015] In another general aspect, the invention features a modular
chemistry analysis test unit for a chemistry analyzer that includes
one or more vessels for one or more reagents, and a
machine-readable test specification coupled with the vessels and
identifying a series of test operations that employ the reagents
for the vessels The specification includes one or more reagent
quantity specifications that specify a quantity of the reagents to
mix with a test sample, and one or more reaction duration
specifications that specify a reaction time for the reagents and
test sample.
[0016] In preferred embodiments, the machine-readable test
specification can be stored in an RFID tag affixed to the vessel.
The machine readable test specification can further include at
least one test type specification defining a type of test to be
performed. The machine readable test specification can further
include at least one result value specification defining an
acceptable result value for a test to be performed using one or
more of the reagents. The test unit can further include a
machine-readable storage area for a fill level value. The
machine-readable storage area for a fill level value can be a
read-write storage area. The machine-readable tag can be affixed to
one or more of the vessels with an adhesive.
[0017] In a further general aspect, the invention features a
machine-readable identification tag for chemistry analysis test
units for use in a chemistry analyzer that includes a
machine-readable test specification defining a series of test
instructions for access by sequencing logic, which include one or
more reagent quantity specifications that specify a quantity of
reagent to mix with a test sample, and one or more reaction
duration specifications that specify a reaction time for the
reagent and test sample.
[0018] In preferred embodiments, the tag is can be an RFID tag. The
machine readable test specification can further include at least
one test type specification defining a type of test to be
performed. The machine readable test specification can further
include at least one result value specification defining an
acceptable result value for a test to be performed according to the
reagent quantity specification and the reaction duration
specifications. The tag can further include a machine-readable
storage area for a fill level value. The machine-readable storage
area for a fill level value can be a read-write storage area. The
tag can further include an adhesive area to affix the tag to a
portion of the chemistry analysis test unit.
[0019] In another general aspect, the invention features a method
of operating a chemistry analyzer method that includes determining
usage levels associated with a plurality of storage vessels that
store reagents for use by the analyzer, displaying to the operator
a pictorial representation that includes a plurality of graphical
elements that convey levels of usage for the storage vessels, and
displaying a series of access icons that are each associated with a
color and each lead to a set of screens for different types of
operations for the analyzer, wherein the screens are color coded to
correspond to the color associated with their respective access
icons.
[0020] In preferred embodiments, the method can further include the
step of identifying the contents of a plurality of storage vessels
that store samples for use by the analyzer, and the step of
displaying to the operator a pictorial representation that includes
a plurality of elements that identify the contents of the storage
vessels. The pictorial representation of the reagent vessels and
the sample vessels can be part of a combined representation. The
pictorial representation can be a mapped pictorial representation
in which positions of the graphical elements on the display
correspond to positions of the vessels in the analyzer. The
pictorial representation can employ a colored bar to convey usage
levels. The pictorial representation can include elements that
identify the reagents in the storage vessels. The step of
displaying access icons can display icons that include at least a
worklist icon and a results icon. The step of displaying access
icons can display icons that include at least a worklist icon and a
status icon. The step of displaying access icons can display icons
that include at least a results icon and a status icon. The step of
displaying access icons can display icons that include a worklist
icon and a diagnostics, maintenance, and/or setup icon. The step of
displaying access icons can display icons that include a results
icon and a diagnostics, maintenance, and/or setup icon. The step of
displaying access icons can display icons that include a status
icon and a diagnostics, maintenance, and/or setup icon. The step of
displaying access icons can display icons that include a status
icon and a diagnostics, maintenance, and/or setup icon. The step of
displaying access icons can display icons that include a worklist
icon, a status icon, and a diagnostics, maintenance, and/or setup
icon. The step of displaying access icons can display icons that
include a worklist icon, a results icon, and a diagnostics,
maintenance, and/or setup icon. The step of displaying access icons
can display icons that include a results icon, a status icon, and a
diagnostics, maintenance, and/or setup icon. The step of displaying
access icons can display icons that include a worklist icon, a
results icon, and a status icon. The step of displaying access
icons can display icons that include a worklist icon, a results
icon, a status icon, and a diagnostics, maintenance, and/or setup
icon.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] FIG. 1 is a perspective view of an illustrative modular
chemistry analyzer according to the invention;
[0022] FIG. 2 is a perspective view of the chemistry analyzer of
FIG. 1 showing fluidics components and covers for operator use in
phantom;
[0023] FIG. 3 is a perspective view of the chemistry analyzer of
FIG. 1 with its inner cover removed to reveal functional
subassemblies as accessed by service personnel;
[0024] FIG. 4 is a plan view of a base for use in the chemistry
analyzer of FIG. 1;
[0025] FIG. 5A is a cross-sectional view of a boss-pin pair for the
base of FIG. 4;
[0026] FIG. 5B is a cross-sectional view of a another type of
boss-pin pair for the base of FIG. 4;
[0027] FIG. 5C is a cross-sectional view of a further type of
boss-pin pair for the base of FIG. 4;
[0028] FIG. 6 is a front isometric view of the base of FIG. 4;
[0029] FIG. 7 is a rear isometric view of the base of FIG. 4;
[0030] FIG. 8 is an exploded assembly drawing showing the bottom of
the base of FIG. 4 and its stiffening plate;
[0031] FIG. 9 is a rear perspective view of the chemistry analyzer
of FIG. 1 with its electronics subassembly shown in its open
position;
[0032] FIG. 10 is a partial perspective view of the illustrative
modular chemistry analyzer of FIG. 1, showing the installation of
an optional cooling unit fan in the reagent/sample area;
[0033] FIG. 11 is a partial perspective view of the illustrative
modular chemistry analyzer of FIG. 1, showing the installation of
its power supplies behind the reagent/sample area;
[0034] FIG. 12 is a rear-facing partial perspective view of the
illustrative modular chemistry analyzer of FIG. 1, showing the
installation of its electronics subassembly;
[0035] FIG. 13 is a partial perspective view of the illustrative
modular chemistry analyzer of FIG. 1, showing the installation of
its reagent/sample carousel subassembly;
[0036] FIG. 14 is a partial perspective view of the illustrative
modular chemistry analyzer of FIG. 1, showing the installation of
its heater;
[0037] FIG. 15 is a partial perspective view of the illustrative
modular chemistry analyzer of FIG. 1, showing the installation of
its reaction area carousel drive subassembly;
[0038] FIG. 16 is a partial perspective view of the illustrative
modular chemistry analyzer of FIG. 1, showing the installation of
its cuvette carousel and air filter above the reaction area
carousel drive subassembly;
[0039] FIG. 17 is a partial perspective view of the illustrative
modular chemistry analyzer of FIG. 1, showing the installation of
its transfer arm subsystem;
[0040] FIG. 18 is a partial perspective view of the illustrative
modular chemistry analyzer of FIG. 1, showing the installation of
its fluidics subsystem drawer base;
[0041] FIG. 19 is a partial perspective view of the illustrative
modular chemistry analyzer of FIG. 1, showing the installation of
its fluidics subsystem drawer front;
[0042] FIG. 20 is a partial perspective view of the illustrative
modular chemistry analyzer of FIG. 1, showing the installation of
its photometer.
[0043] FIG. 21 is a perspective view of an illustrative two-part
reagent container for use with the chemistry analyzer of FIG.
1;
[0044] FIG. 22 is an illustrative memory map for the illustrative
reagent container for use with the chemistry analyzer of FIG.
1;
[0045] FIG. 23 is a flowchart illustrating the operation of the
chemistry analyzer of FIG. 1; and
[0046] FIG. 24 is a screenshot of a worklist screen for the
chemistry analyzer of FIG. 1.
DESCRIPTION OF AN ILLUSTRATIVE EMBODIMENT
[0047] Referring to FIGS. 1-2, an illustrative embodiment of a
modular chemistry analyzer 10 according to the invention includes a
reagent/sample area 12, a transfer arm/probe 14, a reaction area
16, a fluidics drawer 18, and a diluent/waste bottle area 20. The
analyzer is also equipped with a computer 24 and a touch screen
22.
[0048] Referring to FIGS. 2-3, a first pivoting cover 30 encloses a
reagent/sample carousel subassembly 50 in the reagent/sample area,
and a second pivoting cover 32 encloses a reaction carousel
subassembly 70 in the reaction area. A transparent pivoting
fluidics drawer front 34 protects a fluidics area 40 mounted on a
sliding drawer base 36. The fluidics area can include an optional
module that includes a series of Ion-Selective Electrode (ISE)
sensors 42 and peristaltic pumps 48. The fluidics area also
includes a diluter pump 46. Mounted to the ISE sensor module is a
probe wash cup 44.
[0049] Referring to FIG. 3, the reagent/sample carousel subassembly
50 includes a reagent tray 52 supported by a carousel drive
subassembly 56 that is above an optional cooling unit 58, such as a
Pelletier cooling module and its associated cooling fan 57 (see
also FIGS. 10 and 13). It also includes a removable sample ring 54
that holds sample containers 60 and is loaded on top of the reagent
tray, after it is loaded with reagent containers 62 during the
ordinary course of operation (see also FIG. 21). A Radio Frequency
Identification (RFID) reader 68 can be located in the analyzer's
base adjacent the carousel drive subassembly, as well, to interact
with RFID tags associated with the reagent containers. An optional
bar code reader that is mounted on the base adjacent to the sample
ring can read bar codes on the sample containers.
[0050] The reaction carousel subassembly 70 includes a cuvette
wheel 72 mounted on a reaction carousel drive subassembly 74
adjacent a photometer 76 and above a heater 80. The transfer
arm/probe 14 is part of a transfer arm/probe subassembly 82 that is
positioned off-axis between the two carousels. Power supplies 84
are mounted behind the transfer arm, and an electronics subassembly
86 is mounted in a case 38 at the back of the analyzer (see also
FIG. 12).
[0051] Referring to FIGS. 4-7, a unitary base 90 supports the
analyzer's subassemblies in a predetermined way. The base employs
supports, such as pins 94 and bosses 96 to precisely and accurately
position the subassemblies (e.g., the sample/reagent subassembly).
The pins are designed to interact with holes in the subassemblies
to constrain them at predetermined horizontal positions (i.e., in
the x- and y-directions). The bosses are designed to position the
subassemblies at predetermined heights (i.e., in the z direction).
The unitary molded base and pins and bosses minimize stack-up
between the elements and greatly reduce the manufacturing and
assembly costs of this embodiment.
[0052] The pins 94 and bosses 96 can be provided in different types
of pairs 92 as shown in FIGS. 5A-5C, but they can also be placed at
separate locations. A pin and boss may be paired to provide
horizontal constraint as well as vertical constraint, as
illustrated in FIG. 5C.
[0053] A support is a part or portion of a part, such as the base,
that provides an opposing force to a point on a subassembly. The
minimum number of supports required is defined by the number of
degrees of freedom that need to be constrained. An object that is
otherwise unconstrained, for example, would require at least two
vertical supports, such as two pins, and three horizontal supports,
such as three bosses. One pin would prevent horizontal
translations, but not rotation, and a second pin would fully
constrain a subassembly in the x-y plane. And, like a stool
generally requires at least three legs, three point bosses are used
to support an otherwise unconstrained subassembly in the
z-direction.
[0054] Some subassemblies may only need to be partially
constrained, or may not need to be constrained at all. The
analyzer's power supplies, for example do not need to be
constrained precisely, so there is no need to provide pins and
bosses for them. Other subassemblies could be constrained precisely
in one or more directions, but not in one or more others. And while
cost dictates that it is generally preferable to use a minimum
number of pins and bosses to achieve a set of target constraints,
additional pins and bosses could also be used in some
circumstances, such as to support a large or flexible subassembly.
In some situations it may even be possible to provide one precisely
shaped larger surface to define two or more supports at different
positions. Other types of precisely dimensioned vertical
constraints could also be provided, such as irregularly shaped pins
or precisely dimensioned blades, teeth, or walls.
[0055] Screws can secure the constrained subassemblies in place but
are not appropriate for aligning the subassemblies. This is because
screws need room to move within their holes, they are typically not
manufactured with a high degree of precision, and they may be
replaced in the field with similar-looking but differently
dimensioned screws. The act of installing screws can sometimes also
damage their through holes, especially if the subassembly is not
precisely positioned before installation begins. The screws
therefore only serve to secure the subassemblies and can cooperate
with tapped inserts 98, which can be located in the bosses. Other
types of fastening arrangements could also be employed, such as
cams, clamps, or barbs. The pins and horizontal supports used for
the base in one embodiment are listed in table 1.
TABLE-US-00001 Subassembly Description Transfer arm Single pin
lines up with axis of rotation of transfer arm, and minimum of
three horizontal supports. Reaction carousel Minimum of two pins
and three horizontal supports Reagent/sample Minimum of two pins
and three horizontal supports carousel
[0056] The use of pins, bosses, and other ways of providing
supports can allow for easy assembly and very high precision
positioning of subassemblies, at a relatively low cost. In one
embodiment suitable for prototyping or small runs, for example, the
base is first molded in a conventional manner, such as using a
conventional cast urethane process. Holes for the pins and the
upper boss surfaces are then precisely machined using a numerical
milling machine. While the precision machining can add some cost to
the base, this cost amounts to a relatively small portion of the
overall cost of the analyzer, and it is offset by several benefits.
In another embodiment suitable for larger runs, adequate tolerances
have been achieved, without machining, using Noryl, a Polyphenylene
Oxide (PPO) engineering thermoplastic available from General
Electric.
[0057] A first benefit of the base construction is that it makes
the analyzer easy to assemble and service. Assembly technicians and
field service technicians can quickly position a subassembly by
first aligning holes in the assembly with the pins that constrain
it and then dropping the subassembly into place. Getting the pins
and holes to line up is an operation that has is very definite feel
to it, so the technician immediately knows the part is properly
engaged. And once engaged, the subassembly is perfectly positioned,
so there is no need to adjust its position during assembly. The
analyzer can also be built to be assembled and disassembled with a
single tool, such a number two Phillips screwdriver.
[0058] Simplifying assembly can also reduce the length and
complexity of service and subassembly replacement tasks, and
thereby allow them to be performed by less skilled personnel, such
as sales representatives or even hospital staff. This can
significantly reduce the cost of these tasks, particularly in
remote areas. And simplifying service tasks can reduce the
complexity of service manuals, which can then be more easily
translated.
[0059] Another benefit of the unitary base construction is that it
can reduce or eliminate the need for calibration of the transfer
arm. With the subassemblies positioned precisely relative to each
other, the transfer arm may be able to employ a preset travel
range. It therefore need not go through an initial calibration
routine or be "taught" by a technician where its different landing
points are. If a calibration step is still needed, this step may be
designed to take less time than might otherwise be required.
[0060] The molded base 90 is designed to eliminate tolerance
stack-up in this embodiment. This can be achieved by carefully
designing the order and reference points for distance measurements
used in cutting the base mold. Basing measurements from the
transfer arm axis pin T1 to pins that constrain the probe's service
points, for example, will avoid the accumulation of tolerances that
could result if the position of all of these pins were to be based
on an arbitrary reference. This contrasts with the difficulties and
expense that appears to have been required in prior art designs to
control tolerance stack-up between probe, reagent containers,
sample containers, reaction cuvettes, probe wash station, and other
elements. The use of plastic in the base also reduces thermal
expansion errors in this embodiment.
[0061] Referring to FIG. 8, to maintain precise positional
tolerances, the base is also preferably reinforced, such as with
webbing 88 and a stiffening plate 89. The use of a stiffening plate
is an alternative to thick webbing, and it therefore reduces the
overall height of the analyzer. The reinforced base is also solidly
bolted to a rear portion that defines the electronics subsystem
case 38, as shown in FIG. 9, to make it even stiffer.
[0062] Referring to FIG. 10, assembly of the analyzer includes the
installation of the fan 57 for the optional cooling unit 58 in the
sample/reagent area 12. This fan is held down with screws, but does
not require pins or bosses.
[0063] Referring to FIG. 11, the power supplies are inserted into
an area behind the sample/reagent area. This location makes them
relatively easy to replace. As discussed above, the power supplies
do not require precise positioning, so no pins or bosses are
provided for them. The power supply is connected to the various
components that it supplies via a series of cables, which are
preferably equipped with connectors, such as plug and socket
connectors, to simplify assembly, disassembly, and servicing.
[0064] Referring to FIG. 12, the electronics subassembly 86 is made
up of a mother board and daughter cards. The mother board is
screwed to a hinged cover 87 for the case 38 at the back of the
analyzer. In this highly accessible position, it is easy to
diagnose failures, and/or repair or replace the assembly, its
daughter cards, or other components.
[0065] The purpose of the electronic subassembly 86 is to control
the operation of the analyzer and relay results to the operator. It
is therefore electrically connected to various parts of the
analyzer via a number of wires and/or cables. These are preferably
equipped with connectors, such as plug-and-socket connectors, to
simplify assembly, disassembly, and servicing.
[0066] Referring to FIG. 13, the reagent/sample tray drive and
cooling subassembly 56 is screwed in place above the cooling unit
fan 57 in the sample/reagent area 12 of the analyzer. As presented
earlier, this subassembly is precisely positioned within the
transfer arm's range using two pins and three bosses.
[0067] Referring to FIG. 14, the heater 80 is held in place in the
reaction area by screwing it to two posts that are integral to the
base 90. These height of these posts need not be precisely defined
as the heater does not need to be positioned with a high degree of
precision.
[0068] Referring to FIG. 15, the reaction area carousel drive
subassembly 74 is screwed in place on three posts. These posts are
precisely defined, such that some or all of their top surfaces can
act as bosses, and two of them include pins. An air filter 78 is
installed above the drive mechanism, and the cuvette wheel 72 can
then be screwed to the reaction area carousel drive mechanism above
the air filter, as shown in FIG. 16. The wheel holds disposable
transparent reaction cuvettes ganged in groups of six.
[0069] Referring to FIG. 17, the transfer arm subassembly 82 is
screwed onto a series of three bosses and constrained by two pins,
with one of the pins being placed directly below the axis of
rotation of the transfer arm. This precise positioning keeps the
transfer arm and post at an exact relative position with respect to
the various points that it needs to service, including one or more
openings in the reagent and sample containers on the reagent/sample
carousel, cuvettes on the cuvette carousel, the wash cup, and a
sample cup on the ISE sensor module.
[0070] Referring to FIG. 18, the fluidics drawer base 36 is
attached to the top of the base 90 of the unit with four screws. It
is also constrained by bosses and pins to keep its ISE sensor
module 42 and probe wash cup 44 precisely positioned within the
transfer arm's range. One of the mounting screws is grounded.
[0071] Referring to FIG. 19, the transparent pivoting fluidics
drawer front 34 is pivotably mounted on the drawer base 36 using a
pair of brackets and four screws. This component does not need to
be constrained with a high degree of precision, since its only
purpose is to act as a cover.
[0072] The use of a sliding fluidics drawer makes the fluidics
subassembly easy to access and troubleshoot. Bubbles and blocked
lines are clearly visible through the transparent cover 34 or with
the drawer open, and some fluidics items may even be repaired or
replaced without removing the analyzer's covers.
[0073] Referring to FIG. 20, the photometer 76 is mounted on a
pedestal 94 that is integral to the base at the rear of the
reaction area. It is supported by two rear bosses and one front
boss. A screw interfaces with a tapped insert between the two rear
bosses to hold the photometer to its pedestal. This arrangement is
sufficient to position the photometer with respect to the cuvette
carousel and thereby allow it to take photometric measurements
through the transparent cuvettes.
[0074] The assembly tasks described above cover the bulk of the
assembly of the illustrative chemistry analyzer 10. One of ordinary
skill in the art would of course recognize that there are a variety
of smaller assembly steps, such as the attachment of covers and the
installation of cables, hoses, and other small parts. But these
details do not bear on the invention and have been omitted in the
interest of clarity.
[0075] In operation, referring to FIGS. 1-3, the user begins by
loading one or more reagent containers 62 in the reagent tray 52
and one or more disposable cuvettes in the cuvette wheel 72. The
user also installs the sample ring 54 and any sample containers 60
that contain samples for analysis. After closing the reagent
carousel cover, the analyzer performs a reagent inventory and/or a
sample inventory (see FIG. 23 and accompanying text). The analyzer
is now ready to carry out analysis tasks for the different samples
using one or more reagents from one or more containers in the
reagent tray.
[0076] Referring to FIGS. 21-22, all of the information required to
carry out the analysis sequence for each the reagents is contained
in an RFID tag 64 under the label 66 of its reagent container 62.
As shown in FIG. 22, this information can include: name, lot
number, and expiration date, reagent volumes(s), reagent and sample
blanking, analysis volumes for reagents, samples, and diluent,
linear range of assay, primary and secondary wavelengths for
photometric measurements, acceptable absorbance ranges, reaction
read times, and urine parameters.
[0077] Storing all of this protocol information in the RFID tags in
the reagent containers themselves can help to ensure that no test
is ever conducted with an incorrect protocol. And there is no need
to update the analyzer's software periodically to ensure that it is
compatible with new tests. Instead, all of the information needed
to run new tests and improvements to old tests can be simply read
from the RFID tags on the reagent containers in the reagent tray,
and the analyzer will use them correctly.
[0078] Storing the analysis protocol in the RFID tags on the
reagent containers also has the advantage of allowing the container
manufacturer to tailor the protocol for different reagent batches.
If the manufacturer receives a reagent with a very slightly lower
concentration than it specified, for example, reaction times can be
slightly altered to correct for this discrepancy without any impact
on precision or accuracy. This level of flexibility can even reduce
the cost of producing reagents by relaxing the required tolerances
for reagents. And it can increase the sensitivity of tests even if
the reagents are within conventional, narrow ranges, by setting
reaction parameters exactly for each batch instead of at a target
nominal value that is good for all batches.
[0079] The RFID tags in the reagent containers can also store
information received from the analyzer during operation, such as
updated reagent volumes. Storing this information in the reagent
containers can allow them to be moved from one analyzer to another
or even allow them to survive computer failures without loss of
reagent volume information. This can help to avoid a potentially
serious situation in which no reagent of a particular type is on
hand because the amount of reagent in existing containers was not
known correctly.
[0080] Referring to FIG. 23, upon startup or user request, the
analyzer initiates a reagent inventory operation in which the
reagent tray is rotated to expose each of the reagent containers to
the RFID reader 68 (step 100). The analyzer first retrieves the
contents of a first tag (step 102). It can then check it to
determine whether it holds a new protocol (step 104), and store it
if it does (step 106). The test protocols can be stored in storage
located in the analyzer housing, in storage located in the
computer, or in another location, such as a central networked
server. The inventory process is repeated for all of the reagent
containers in the system (see step 108).
[0081] Once the protocols are stored, the system is ready to select
and initiate analysis tasks (step 110). Each test begins with the
analyzer accessing the stored test protocol corresponding to the
reagent container to be used (step 112). The various subsystems
then carry out the sequence of events in the test protocol (step
114). A sample and reagent might be mixed in a cuvette, for
example, and the result tested using the photometer after a
specified reaction read time. The test result is then stored (step
116), and further tests can be conducted for further samples (step
118).
[0082] The flowchart shown in FIG. 23 is illustrative only, and the
inventory and test operations can take place according to other
sequences. It may make sense in some instances to simply record all
protocol data for all reagent containers, for example, even if data
for some or all of them is redundant. Analysis tasks may also be
interleaved to save time.
[0083] Inventory initiation can be made mandatory each time that
reagents and/or samples could be removed from the system. For
example, the inventory can be initiated each time the cover 30 for
the reagent/sample carousel subassembly is closed. This interlock
mechanism can prevent errors by ensuring that regent or sample
containers are not replaced, moved, or removed before testing
begins.
[0084] Referring to FIG. 24, the operator can interact with the
analyzer 10 through a series of software-generated views presented
on the touch screen 22. The worklist screen 200, for example,
includes one or more status icons 202, an icon bar 204, a visual
representation 206 of half of the reagent tray 52/sample ring 54,
and a data table 208. The visual representation shows what reagent
containers are in the reagent tray based on the results of an
earlier inventory, by displaying a series of wedge shapes that are
similar to the shape of the reagent containers. It also shows
occupied positions in the sample ring as white numbered circles and
unoccupied positions in shaded circles positioned in a semicircular
area that is similar to the sample ring. The quantity of reagent
left in each reagent container is shown as a shaded area that
resembles a fill level in the wedge shape, and the reagent
containers are identified by standard abbreviations (e.g., Ca for
calcium). The data table shows a list of tests that correspond to
the different sample areas, which are referenced by their numbers
in the visual representation. Together, the elements of the
worklist screen allow the user to quickly understand the status of
the system and the run of tests that is about to begin.
[0085] The icon bar 204 includes four differently colored icons
that divide the operation of the system into four functional areas.
Touching these icons leads the user to menus allowing him or her to
select from a series of sub-screens in each of these areas. Each of
the sub-screens is color coded to remind the user what type of task
he or she is performing.
[0086] This approach of using a combination of color coding and
visual representations helps orient the user and avoid errors. This
can be particularly helpful for users for whom the language used by
the analyzer is a second language. It also allows the analyzer to
use text more sparsely, which is beneficial for models deployed in
a variety of different markets, as the user interface can be
designed with little or no text that needs to be translated.
[0087] In one embodiment, the four icons include a woorklist icon
210 (blue), a results icon 212 (orange), a status icon 214 (green),
and a diagnostics/maintenance/setup icon 216 (pink). The worklist
group accessible from the worklist icon 210 includes a view LIS
list entry, an edit worklist entry, a monitor worklist entry, a
view pending list entry, and an ISE calibration entry. The results
group accessible from the results icon 212 includes a current
results entry, a last results entry, a patient results entry,
calibration results entry, a quality control results entry, and an
other tables entry. The status group accessible from the status
icon 214 includes a worklist warnings entry, a reagents entry, a
calibration entry, a quality control entry, a cuvettes entry, an
ISE entry, a cleaning entry, an inventory report entry, and a
sample inventory entry. The diagnostics/maintenance/setup group
accessible from the diagnostics/maintenance/setup icon 216 includes
a cleaning entry, a diagnostics entry, a maintenance entry, and a
setup entry. The setup entry includes sub-entries for system,
tests, patient, calibration, quality control, and reagent. One of
ordinary skill in the art will recognize that the exact breakdown
of the screens is highly dependent on the detailed characteristics
of the particular chemistry analyzer, and that there are a variety
of different, reasonable ways to organize the screens for a given
analyzer.
[0088] The various tasks performed by the analyzer can be carried
using a specially programmed general purpose computer, dedicated
hardware, or a combination of both. In one embodiment, the system
is based on a Microsoft Windows.RTM.-based computer system, but
other platforms could be used as well, such as Apple McIntosh.RTM.,
Linux.RTM., or UNIX.RTM.-based platforms. And while the touch
screen is a currently a preferred user interface device, other
types of devices could also be used, such as mice, keyboards, or
trackballs. Other embodiments can even employ a simple, hardwired
keypad instead of a computer.
[0089] The present invention has now been described in connection
with a number of specific embodiments thereof. However, numerous
modifications which are contemplated as falling within the scope of
the present invention should now be apparent to those skilled in
the art. It is therefore intended that the scope of the present
invention be limited only by the scope of the claims appended
hereto. In addition, the order of presentation of the claims should
not be construed to limit the scope of any particular term in the
claims.
* * * * *