This invention generally relates to the field of automated clinical chemical analyzers, and specifically to high throughput automated chemical analyzers having reagent carousels.
A number of special purpose analyzers are available for the measurement of various analytes in human body fluid samples. In the past, such analyzers were often adapted to test for a single analyte in a patient sample and may have required extensive operator actions to perform an analysis. For example, the operator might be required to perform manual pipetting of patient samples and reagents into a test chamber or cuvette, manual timing of the reaction, and the manual reading of an arbitrary value from the analyzer that is then compared to previously generated calibration values to obtain a final result. As is readily apparent, largely manually operated analyzers are not suitable for either a large number of patient sample analyses or to performing an analysis in a limited amount of time.
In order to meet the increasing demand for the routine testing of a growing number of analytes as well as for the reduction in overall testing costs and the skill required of the technician/operator, many analyzers are now partially or fully automated. A typical automated analyzer can analyze a single fluid sample for a plurality of analytes with little or no intervention on the part of an operator.
The number of different analytes or chemistries that an automated clinical analyzer can analyze is often termed the “menu” of chemistries available on the analyzer. Large scale, highly complex analyzers useful in large hospitals and clinical laboratories have been developed which have both a large menu of tests which the instrument can perform and a high throughput. An automated analyzer may be designed, for example, to analyze a limited menu of basic chemistries that represent the bulk of the work load in a clinical chemistry laboratory, such as glucose, creatinine, sodium, potassium and the like. On the other hand, other analyzers may offer a much larger menu, sometimes ranging up to 50 or 60 different chemistries. Many of such chemistries may represent relatively low volume chemistries, that is, ones that are required on an infrequent basis as compared to the basic chemistries mentioned above.
Each chemistry run on an analyzer generally requires its own unique reagent or combination of reagents. Although it would be desirable to maintain all of the reagents on the analyzer for each of the chemistries on the menu, most large menu analyzers do not have the storage capacity to do so. Instead, reagents for a subset of the menu are stored on the analyzer at one time. When an analysis is to be run that requires reagents that are not presently stored on board the analyzer, the reagents must be placed onto the analyzer before the analysis is run. If the reagent storage area on analyzer is already full, then reagents for a chemistry not in use are removed and the reagents for the new chemistry are installed in their place. With such an approach, it is desirable that the analyzer maintain as many reagents on board as possible and, further, that reagents be easily removed and replaced so that analyzer down time and operator time can both be minimized.
It is known in the art to use reagent cartridges on automated clinical analyzers to increase the ease with which reagents are handled and decrease the time required to reconfigure the chemistries on board the analyzer. Such cartridges may contain all of the various reagents required for a particular chemistry and may be configured to fit onto a reagent storage rack or wheel within the analyzer. These storage racks or wheels are typically moveable such that the reagents may be automatically moved into and out of a loading position. Moveable reagent storage racks, including those in the form of rotatable wheels, are referred to herein as reagent “carousels”.
The limited storage capacity for reagent cartridges in automated clinical analyzers is problematic, as laboratory technicians and other users of the analyzers can spend significant amounts of time loading and unloading reagent cartridges from the reagent carousels. This loading time results in lower volumes of chemistry runs because of the downtime to change or add more reagents. Thus, it would be desirable to provide an automated clinical analyzer with increased reagent storage space, allowing the downtime for the automated clinical analyzer to be significantly reduced. Although increased storage space could be achieved by providing a much larger analyzer, substantial increases in the size of the analyzer are unrealistic from a cost and space perspective. Accordingly, it would be advantageous to provide and automated clinical analyzer that significantly increases the reagent storage space without substantially increasing the size or cost of the automated clinical analyzer.
An automated clinical analyzer comprises a storage rack including a first plurality of reagent cartridge seats and a second plurality of reagent cartridge seats. The first plurality of reagent cartridge seats are positioned higher than the second plurality of reagent cartridge seats. Accordingly, the automated clinical analyzer provides for multiple levels of reagent storage in the vertical direction.
In one embodiment, the automated clinical analyzer comprises an upper reagent carousel operable to rotate about a central axis and a lower reagent carousel operable to rotate about the central axis. The upper carousel includes the first plurality of reagent cartridge seats and is operable to receive a first plurality of reagent cartridges. The lower carousel includes a second plurality of reagent cartridge seats and is operable to receive a second plurality of reagent cartridges. The analyzer further comprises a reagent probe assembly including a probe tip. The reagent probe assembly is operable to move the probe tip between the upper carousel and the lower carousel and extract liquid reagents from the first plurality of reagent cartridges and the second plurality of reagent cartridges.
The upper carousel includes an opening formed by one of the slots that remains free of a reagent cartridge. The opening in the upper carousel allows the probe to extend through the opening and reach cartridges located on the lower carousel.
A dual carousel drive is provided for rotating the upper carousel and the lower carousel. The dual carousel drive includes a first shaft connected to the lower carousel and a second shaft connected to the upper carousel. The first shaft is hollow and the second shaft is at least partially retained within the first shaft and is rotatable with respect to the first shaft. A first gear hub assembly is connected to the first shaft. The first gear hub assembly is connected to a first electric motor through a first drive train. The first electric motor is operable to engage the first drive train, thereby rotating the first gear hub assembly and first shaft. Rotation of the first shaft results in rotation of the lower carousel. Likewise, the second shaft is connected to a second gear hub assembly, second drive train and second electric motor. The second electric motor is operable to drive the second drive train, which rotates the second gear hub and second shaft. Rotation of the second shaft results in rotation of the upper carousel.
The upper carousel and lower carousel are retained within a housing, and an opening is formed in the housing providing access to the upper and lower carousels. The opening in the housing defines a first loading door and a second loading door. The first loading door is designed and dimensioned to allow a reagent cartridge to pass through the first loading door and into one of the plurality of seats of the first reagent carousel. Likewise, the second loading door is designed and dimensioned to allow a reagent cartridge to pass through the second loading door and into one of the plurality of seats of the second reagent carousel. At least one bar code reader is mounted on the housing near the first loading door and the second loading door. The at least one bar code reader is operable to read a bar code positioned on a reagent cartridge before it passes through the first loading door or the second loading door.
Use of the automated clinical analyzer embodies a method of accessing reagents stored in reagent cartridges in a clinical analyzer. One embodiment of the method comprises loading a first plurality of reagent cartridges onto a first reagent carousel and a second plurality of reagent cartridges onto a second reagent carousel. Next, a reagent probe is moved to a reagent extraction site and the probe extracts a reagent from one of the first plurality of reagent cartridges. After this, the reagent probe is moved away from the reagent extraction site and the extracted reagent is dispensed by the probe. Then, the reagent probe is moved back to the reagent extraction site where the probe is used to extract another reagent from one of the second plurality of reagent cartridges.
The body 12 is typically a cabinet providing a housing for the various operative components. The body 12 is typically made from a lightweight metal such as a lightweight sheet steel. The embodiment shown in
Returning to
The reagent station 16 is sized and dimensioned to retain a plurality of reagent containers 40 known as reagent “cartridges”. An exemplary reagent cartridge 40 is shown in
The reagent station 16 comprises a storage rack operable to retain the plurality of reagent cartridges 40. In the embodiment shown in
With reference to
As mentioned above, the second carousel 202 is substantially identical to the first carousel 200. Accordingly, the second carousel 202 is not explained in additional detail herein.
With reference to
As shown in
With reference to
To remove a cartridge 40 from the carousel 200, the storage compartment 147 of the cartridge is grasped and the cartridge 40 is raised slightly, disengaging the teeth 165 on the cartridge from the depressions 217 on the carousel 200, and enabling the cartridge 40 to be easily radially removed from the slot 216 within the carousel 200.
The first and second carousels 200 and 202 which hold the plurality of reagent cartridges are rotatably mounted in the automated clinical analyzer 10. Because the carousels 200 and 202 are rotatable, the slots of each carousel may be individually positioned in front of the loading doors 185 and 187 of the loading station 180 to facilitate loading and unloading of reagent cartridges. A dual carousel drive is provided in the analyzer 10 under the carousels for controllably rotating each of the carousels. A progressive assembly isometric of the dual carousel drive 250 is shown in
As shown in
As shown in
With reference now to
As shown in
The dual carousel drive 250 is mounted below the upper carousel 200 and lower carousel 202 in the automated clinical analyzer 10. The inner shaft 260 is connected to the hub of the upper carousel 200 and the outer shaft 254 is connected to the hub of the lower carousel. Therefore, rotation of the inner shaft 260 imparts rotation to the upper carousel and rotation of the outer shaft 254 imparts rotation to the lower carousel. The controller 178 determines when power will be provided to the motors of the dual drive assembly, thereby controlling rotation of the upper and lower carousels 200 and 202 and positioning of the upper and lower carousels.
Controlled positioning of the carousels 200 and 202 by stepper motors 280 and 282 not only facilitates loading of the reagent cartridges 40 on to the carousels, but also facilitates proper positioning of the cartridges during operation of the analyzer 10 to allow access to the reagents at the reagent station 16. In particular, with reference to
The automated crane 114, as shown in
The reagent probe 118 is connected to a reagent probe pressure altering mechanism capable of alternatively applying a positive pressure and a negative pressure to the internal chamber 120 of the reagent probe 118. Such pressure altering mechanism can be any of the various pressure altering mechanisms known in the art. Typically, such pressure altering mechanisms are provided by a syringe pump 128, as shown in
When extracting reagents from the reagent cartridges on the upper reagent carousel 200, the upper reagent carousel is rotated such that the cartridge 40 containing the reagent to be extracted by the probe 118 is positioned below the reagent extraction site 42. The probe 118 is then moved from the upper reagent probe position down toward the cartridges 40 on the upper carousel 200 until the tip 122 of the probe passes through one of the openings 149, 151 or 153 and contacts the liquid reagent in the cartridge 40. Upon contacting liquid in the cartridge 40, a liquid level sense assembly 126 alerts the controller 178 that the tip of the probe has contacted liquid, and the probe is moved only a short additional distance such that the probe can extract the proper amount of liquid from the cartridge. After extracting the predetermined amount of liquid reagent, the probe 118 is moved back toward the upper reagent probe position, clear of both carousels 200 and 202, where the probe can be moved to another location for dispensing the liquid reagent. Of course, extraction of reagent from the reagent container 40 results in an adjustment of the liquid level within the container. When reagents from the container 40 have been completely extracted, the controller 178 is further operable to indicate that the container 40 should be replaced by a new cartridge.
When extracting reagents from the reagent cartridges on the lower reagent carousel 202, the upper carousel 200 must first be moved such that the opening 205 in the upper reagent carousel 200 is immediately below the reagent extraction site 42. This opening 205 allows the probe 118 to be moved from the upper reagent probe position, through the upper carousel 200, and down toward the lower reagent probe positions associated with the lower carousel 202. After the opening 205 in the upper carousel is positioned below the reagent extraction site, the lower reagent carousel 202 is rotated such that the cartridge 40 containing the reagent to be extracted by the probe 118 is positioned below the reagent extraction site 42. The probe 118 is then moved from the upper reagent probe position, through the opening 205 in the upper carousel 200, and down toward the lower carousel 200 until the tip 122 of the probe passes through one of the openings 149, 151 or 153 and contacts the liquid reagent in the cartridge 40. As discussed above, upon contacting liquid in the cartridge 40, a liquid level sense assembly alerts the controller 178 that the tip of the probe has contacted liquid. The probe is then moved only a short additional distance such that the probe can extract the proper amount of liquid from the cartridge.
After reagents are extracted and dispensed by the reagent probe 118, the reagent probe is cleaned using a probe tip cleaning assembly/collar 105, as shown in
One embodiment of an exemplary crane assembly 114, not including the probe 118, is shown in
With reference now to
The reaction cup analyzing station 20 of the automated clinical analyzer 10 comprises at least one reaction cup module 58. Each reaction cup module 58 can be used to measure high volume analyses such as analyses for sodium, potassium, glucose, creatinine and blood urea nitrogen. In the embodiment shown in
The ion selective electrode analyzing station 22 of the automated clinical analyzer 10 comprises a sample injection cup 60 disposed in fluid tight communication with a flow cell analyzer 62 is capable of measuring at least one electrolyte in a liquid sample. The ion selective electrode analyzing station 22 can be used to simultaneously analyze for sample electrolytes, such as sodium, potassium, calcium, chlorine and carbon dioxide. The sample injection cup 60 is disposed in fluid tight communication with an ion selective electrode analyzing station pump 64. The pump 64 is capable of pumping at least one ion selective electrode analyzing reagent from a source of such reagent (not shown) through the sample injection cup 60, through the flow cell analyzer 62 and then to a suitable waste disposal site. In the sample injection cup 60, the sample is mixed with reagent as the reagent is pumped through the sample injection cup 60 and into the flow cell analyzer 62. With this configuration of the ion selective analyzing station 22, reference solution, following each sample analysis, can be delivered into the flow cell analyzer 62. Measurement of the concentrations of sodium, potassium, calcium, chloride, and carbon dioxide in the reference solution can be performed to check electrode drifts, as will be recognized by those of skill in the art.
In the embodiment of the analyzing machine 10 shown in
The loading mechanism path 74 has a motorized loading path arm 82 which moves a single sample container rack 34 along the loading mechanism path 74 on to and off from the sample station 14. A bar code reader 84 is typically disposed along the loading mechanism path 74. The bar code reader 84 is capable of reading bar coded information disposed on each individual sample container 32 as the sample container 32 moves along the loading mechanism path 74.
In the embodiment shown in
The analyzing machine 10 further comprises a motorized sample probe arm assembly 90 such as shown in
Similar to the reagent probe 118, the sample probe arm 92 is movable by a sample probe arm motor (not shown) between a first sample probe arm position wherein the sample probe is immediately above the sample extraction site 38 and a second sample probe arm position wherein the sample probe is immediately above the cuvette sample deposit site 50. The sample probe 94 is connected to a sample probe pressure altering mechanism capable of alternatively applying a positive pressure and a negative pressure to the internal chamber 96 of the sample probe 94, such as a syringe pump 112. The sample probe arm assembly 90 is used to extract a predetermined quantity of sample from sample container 32 disposed within the sample station 14 at the sample extraction site 38 and transport that quantity of sample to a cuvette 44 disposed within the random access analyzing station 18 at the cuvette sample deposit site 50.
The analyzing machine 10 further comprises a cup analysis probe arm assembly 134 including a cup analysis probe arm and cup analysis probe. The cup analysis probe arm assembly 134 is used to extract a predetermined quantity of sample from a sample container 32 disposed within the sample station 14 and transport that quantity to each of the reaction cup modules 58 and to the sample injection cup 60. To this end, the cup analysis probe arm is movable between a first cup analysis probe arm position wherein a cup analysis probe is immediately above a sample container 32 in the sample station 14, a second cup analysis probe arm position wherein the cup analysis probe is immediately above one of the reaction cup modules 58, and a third cup analysis probe arm position wherein the cup analysis probe is immediately above the sample injection cup 60. The cup analysis probe assembly includes a cup analysis probe pressure altering mechanism capable of alternatively applying a positive pressure and a negative pressure to the cup analysis probe. Such pressure altering mechanism can be any of the various pressure altering mechanisms known in the art. Typically, such pressure altering mechanisms are provided by a syringe pump.
Each of the pressure altering mechanisms usable in the analyzing machine can further comprise an obstruction detector 176 comprising a pressure detector operatively installed within the operative pressure transmitting conduits to alert the operator and/or shut down the machine should an obstructive pressure drop be detected within the pressure altering mechanism.
The analyzing machine 10 further comprises a cuvette stirring rod assembly 156, which includes an elongate rotatable cuvette stirring rod. The cuvette stirring rod arm assembly 156 is positionable above the cuvette mixing site 54. In addition, the analyzing machine 10 comprises a cuvette wash station 166. The cuvette wash station is used to extract liquid reaction mixtures from the cuvettes 44, dispose such mixtures to a suitable disposal site and then rinse and clean the cuvette 44 so that it can be used to analyze another quantity of sample.
As discussed above, the automated analyzing machine 10 includes a controller 178. The controller is operable to control each of the various motors of the machine 10 in a way which provides for the smooth, efficient and rapid operation of the machine 10. The controller 178 is typically also used to retain and report analysis data. Preferably, the controller 178 comprises a digital computer which can be preprogrammed with a large variety of operating instructions depending upon the samples being analyzed, the analyses to be run and the reagents at hand. Most preferably, the digital computer receives bar coded information regarding each of the samples to be analyzed, and the reagents in the reagent station 16 and uses that information to most efficiently conduct the analyses. Also, it is preferable that the controller 178 keep track of the amounts of reagents used so as to alert the operator whenever reagent in any particular reagent container 40 begins to run low.
In operation, the operator of the automated analyzing machine of the invention 10 places samples to be analyzed in individual sample containers 32 and places each sample container 32 in one or more sample container racks 34. The sample container racks 34 are placed in the on-load tray 76.
The motorized loading arm 80 pushes sample container racks 34 in the on-load tray 76 towards the loading mechanism path 74. As each sample container rack 34 enters the loading mechanism path 74, the motorized loading path arm 82 pushes the sample container rack 34 along the loading mechanism path 74 towards the sample station 14.
As the sample containers 32 pass by the bar code reader 84, bar-coded information appended to each sample container 32 is read by the bar code reader 84 and is transmitted to the controller 178. Such bar code coded information typically includes the identity of the sample and the analyses which are to be run using individual portions of the sample.
As the sample container rack 34 is pushed further along the loading mechanism path 74, it passes under the cap piercing mechanism 86. The cap piercing mechanism 86 pierces the caps 36 on each of the sample containers 32. The sample container rack 34 then is loaded into the sample station 14 wherein a clamping mechanism within the sample station 14 holds the sample container rack 34 firmly upright.
The sample station 14 is rotated under the control of the controller 178. When an individual sample container 32 is placed at a sample extraction site 38, a small quantity of the sample is extracted from the sample container 32 by the sample probe 94. This is accomplished by positioning the sample probe 94 above the sample extraction site 38, lowering the sample probe 94 to the lower sample probe position wherein the open-ended lower end 98 of the sample probe 94 is placed below the surface of the sample within the sample container 32. A small quantity of the sample is then extracted into the sample probe internal chamber 96 by drawing a vacuum on the sample probe internal chamber 96 using the sample probe pressure altering mechanism. The sample probe 94 is then raised to the upper sample probe position and the sample probe arm 92 moves the sample probe 94 to a position where it is directly above the cuvette sample deposit site 50.
At the cuvette sample deposit site 50, the sample probe 94 is again lowered to the lower sample probe position and the quantity of sample within the sample probe 94 is deposited into a cuvette 44 positioned at the cuvette sample deposit site 50. This is done by creating a slight elevated pressure within the sample probe internal chamber 96 using the sample probe pressure altering mechanism. The lower end of the sample probe 94 is then retracted into the sample probe tip cleaning assembly 104 where it is rinsed using cleaning liquid from the source of cleaning liquid 108. After cleaning, the cleaning liquid is flushed to a suitable disposal site 110. The sample probe 94 is then ready to extract another quantity of sample from another sample container 32.
Contemporaneously with the above-described action of the sample probe 94, the reagent probe 118 is used in similar fashion to extract a quantity of an appropriate pre-mixed reagent from the reagent station 16 and deposit that quantity of reagent into the cuvette 44. Usually the reagent is added to the cuvette immediately prior to the deposit of the sample within the cuvette 44.
To extract a quantity of pre-mixed reagent, the controller 178 first identifies the appropriate slot where the cartridge containing the particular reagent is located. The carousel containing the reagent is then rotated by operation of the dual carousel drive system 250 until the slot holding the reagent cartridge is positioned under the reagent extraction site 42. If the cartridge containing the reagent is on the upper carousel 200, the reagent probe 118 is lowered into the cartridge 40 and reagent is extracted by the probe. If the cartridge containing the reagent is on the lower carousel 202, the upper carousel 200 is rotated to place the opening 205 in the upper carousel directly below the reagent extraction site. The probe is then lowered through the opening 205 in the upper carousel 200 and all the way down to the lower carousel where the probe is lowered into the cartridge and reagent is extracted by the probe. Once the reagent probe has extracted a volume of the desired reagent, the reagent probe is returned to the upper position and the reagent probe arm moves the reagent probe to the cuvette reagent deposit site 52 where the probe dispenses the reagent into the cuvette 44. After reagent is deposited into the cuvette at the reagent dispense position 52, the reaction station 18 is rotated to move the cuvette toward the sample dispense position 40. Approximately three minutes elapse between the time a cuvette receives reagent at the reagent dispense position 52 and the time the cuvette receives a sample at the sample dispense position, as other cuvettes are filled at the random access analyzing station 18 rotates.
After sample and reagent are both added to the cuvette 44, the cuvette 44 is rotated to the cuvette mixing site 54. At the cuvette mixing site 54, the cuvette stirring rod is lowered and the stirring rod is rotated so as to agitate and thoroughly mix the sample and reagent within the cuvette 44. In one embodiment, the mixer is moved to the dispense site 50 or 52 to mix the reagent or sample following introduction of liquid into the cuvette at the dispense site.
In typical random access analyzing operations wherein analyses are carried out at an elevated temperature, the mixture of sample and reagent within the cuvette 44 is then allowed to stand within the random access analyzing station 18 while the mixture is brought up to temperature, such as by blowing heated air through the random access analyzing station 18. In one embodiment, the cuvettes 44 in the random access analyzing station 18 are brought to and held at a carefully controlled temperature by thermal conductivity with the core of the station 18. When a mixture within the cuvette 44 has reached proper temperature, the contents of the cuvette 44 are analyzed using the random access analyzing station analyzer 46. After analyses are completed regarding the mixture within the cuvette 44, the cuvette 44 is moved to the cuvette washing site 56 at the cuvette wash station 166 where the cuvette 44 is rinsed once or several times using pressurized washing liquid. After the rinse liquid is removed from the cuvette 44 and sent to suitable disposal, the cuvette 44 is ready to accept another sample for analysis.
Contemporaneously with the operation of the random access analyzing station 18, high volume analyses may be are performed in the reaction cup analyzing station 20 and in the ion selective electrode analyzing station 22, as is known to those of skill in the art.
After the sample within each of the sample containers 32 in a sample container rack 34 are analyzed, the sample container rack 34 is removed from the sample station 14 using the motorized loading path arm 82. The sample container rack 34 is retracted along the loading mechanism path 74 to the off-load tray 78. Once in the off-load tray 78, the motorized unloading arm pushes the sample container rack 34 towards the end of the off-load tray 78 where it is removed by the operator.
While the dual carousel system described herein provides increased reagent storage space that makes operation of the automated clinical analyzer more efficient, unlimited storage space is, of course, not possible. Therefore, during operation of the automated clinical analyzer, different reagents than those available on the carousels 200 and 202 may be desired. In addition, reagents within individual cartridges will be completely extracted over time. In these situations, reagent cartridges may be easily loaded and unloaded at the reagent loading station 180. When loading reagent cartridges 40, each cartridge is first placed on the upper platform 184 or lower platform 186, depending upon whether the cartridge is to be placed in the upper carousel or lower carousel. When the cartridge is placed on the upper platform 184 or lower platform 186, the associated bar code reader 190 or 192 on the sidewall 194 of the reagent loading station 180 reads the bar code on the side of the cartridge. The bar code contains identification information for the reagent cartridge, and the identification information is associated with the slot where the cartridge is loaded. After the bar code reader indicates that the bar code was successfully read, the cartridge is simply pushed forward, through the upper door 185 or lower door 187 of the reagent loading station 180, and into the slot of the carousel positioned to receive the cartridge. Similarly, when a reagent cartridge is unloaded, the cartridge is pulled from the slot facing the door 185 or 187. As the cartridge exits the door, the bar code reader reads the bar code on the side of the cartridge, and the controller notes that the cartridges has been removed and the slot previously occupied by the cartridge on the carousel 200 or 202 is now open.
One alternative embodiment of the automated clinical analyzer is shown in
Although the present invention has been described with respect to certain preferred embodiments, it will be appreciated by those of skill in the art that other implementations and adaptations are possible. For example, in alternative embodiments of the invention, the storage racks that hold the reagent cartridges may take on different forms, such as a storage rack that moves vertically up and down. Moreover, there are advantages to individual advancements described herein that may be obtained without incorporating other aspects described above. Therefore, the spirit and scope of the appended claims should not be limited to the description of the preferred embodiments contained herein.