MODULAR CHEMISTRY ANALYZER
20180137398 ยท 2018-05-17
Inventors
Cpc classification
G01N35/025
PHYSICS
Y10T436/114165
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
G01N35/10
PHYSICS
G06K19/0723
PHYSICS
International classification
G01N35/02
PHYSICS
G01N35/00
PHYSICS
G01N35/10
PHYSICS
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.
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
BRIEF DESCRIPTION OF THE DRAWINGS
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DESCRIPTION OF AN ILLUSTRATIVE EMBODIMENT
[0047] Referring to
[0048] Referring to
[0049] Referring to
[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
[0051] Referring to
[0052] The pins 94 and bosses 96 can be provided in different types of pairs 92 as shown in
[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
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[0063] Referring to
[0064] Referring to
[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
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[0071] Referring to
[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
[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
[0076] Referring to
[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
[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
[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
[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-based computer system, but other platforms could be used as well, such as Apple McIntosh, Linux, or UNIX-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.