HK40000006B - Method and apparatus to automatically transfer and open a reagent container - Google Patents

Description

Method and apparatus for automated transfer and opening of reagent containers

Cross Reference to Related Applications

This application claims priority to U.S. provisional application serial No. 62/357,909, filed 2016, month 7, day 1, the contents of which are incorporated herein by reference in their entirety.

Technical Field

The present invention relates generally to handling containers in an in vitro diagnostic environment, and more particularly to safely and efficiently transferring and opening reagent containers in a clinical analyzer.

Background

A diagnostic or clinical analyzer may include one or more reagent storage areas dedicated to storing and supplying respective reagents, each reagent storage area including a plurality of reagent containers containing respective reagents. The reagents may be used in the diagnosis of disease, in the monitoring or assessment of therapeutic efficacy, and in safety-related drug detection tests, among other uses. Therefore, handling of the reagents requires significant reliability.

There is a need to protect reagents from waste, spillage and contamination when transferring reagent containers to a reagent storage area of a clinical analyzer or other analytical instrument. Conventional methods of manually dosing and individually loading reagent containers, as well as manually removing caps or puncturing seals to provide access to reagents, all tend to spill, waste through spillage, and cross-contamination. Furthermore, maintaining reagent containers on a clinical analyzer is a time consuming process, causing laboratory personnel to perform repetitive non-ergonomic activities and creating many potential hazards and errors, especially in environments with high volume automated facilities. Another problem is the depletion or unavailability of reagents, resulting in delayed presentation of patient test results and introducing operational errors.

Therefore, there is a need to protect reagents from waste and spillage, reduce operator error, and improve reliability of test results in the transfer and opening of reagent containers in clinical analyzers. There is also a need to provide reagent containers in a safe and effective manner.

Disclosure of Invention

Embodiments relate to automatically transferring and opening reagent containers in a clinical analyzer, for example, in an in vitro diagnostic environment.

In an embodiment, a reagent transfer arm apparatus in a clinical analyzer in an In Vitro Diagnostic (IVD) environment includes: a gripper assembly; a horizontally extending transfer arm to which the gripper assembly is movably coupled and along which the gripper assembly moves in a horizontal direction; and a transfer arm motor configured to control horizontal movement of the gripper assembly along a horizontally extending transfer arm. The gripper assembly comprises: a pair of vertically oriented and mutually opposed gripper fingers configured to move between a release position in which the pair of gripper fingers are separated with respect to each other and a gripping position in which the pair of gripper fingers are urged together with respect to each other, wherein in said gripping position the pair of gripper fingers is configured to grip a portion of a reagent container; a gripper actuator comprising a gripper motor coupled to the pair of gripper fingers and configured to control a horizontal gripping motion of the pair of gripper fingers to move the pair of gripper fingers between the release position and the gripping position; a vertically extending frame, the pair of gripper fingers and the gripper actuator being movably coupled to the frame and moving along the frame in a vertical direction; and a vertical drive motor configured to control vertical movement of the gripper assembly along the vertically extending frame. One or more controllers are configured to control operation of the gripper actuator, gripper motor, vertical drive motor, and transfer arm motor to transfer the reagent container between an access point and a storage region for accessing contents of the reagent container.

In an embodiment, a reagent handling system in a clinical analyzer in an In Vitro Diagnostic (IVD) environment includes: a reagent loading station comprising a tray comprising one or more tray spaces for holding one or more reagent containers, each of the one or more reagent containers being configured to contain a reagent and comprising a gripping portion. The reagent processing system further comprises a reagent transfer arm apparatus comprising: a gripper assembly configured to grip the gripping portion of each of the one or more reagent containers one at a time and move each of the one or more reagent containers into and out of a respective one of the one or more tray spaces; a vertically extending transfer arm to which the gripper assembly is movably coupled and along which the gripper assembly moves in a vertical direction; a vertical drive motor configured to control vertical movement of the gripper assembly along a vertically extending transfer arm; a horizontally extending transfer arm to which the gripper assembly is movably coupled and along which the gripper assembly moves in a horizontal direction; and a transfer arm motor configured to control horizontal movement of the gripper assembly along the horizontally extending transfer arm. The reagent processing system further comprises a reagent server module comprising a storage enclosure comprising one or more indexing rings comprising an indexing space for holding the one or more reagent containers. One or more controllers are configured to control operation of the reagent loading station, gripper assembly, vertical drive motor, transfer arm motor, and one or more indexing rings to provide transfer of the one or more reagent containers between the tray and the one or more indexing rings. A horizontally extending transfer arm of the reagent transfer arm apparatus extends horizontally along a length of the storage enclosure; and, the length of the tray is oriented perpendicular to the length of the horizontally extending transfer arm.

According to an embodiment, a method of processing reagent containers in a clinical analyzer in an In Vitro Diagnostic (IVD) environment includes: identifying, by a controller, a need for a particular reagent to be added to a reagent server module, the reagent server module including one or more indexing rings having one or more indexing spaces; moving the gripper assembly to a reagent loading station by a transfer arm motor configured to control horizontal and vertical movement of the gripper assembly along a horizontally and vertically extending transfer arm, the reagent loading station comprising a tray having one or more tray spaces for holding one or more reagent containers, each of the one or more reagent containers being configured to contain a reagent and comprising a gripping portion, the gripper assembly being configured to grip the gripping portion of each of the one or more reagent containers; scanning, by a barcode scanner on the gripper assembly, a barcode label on each of the one or more reagent containers in the tray until a desired barcode label is identified, the desired barcode label corresponding to a particular reagent and being affixed to a desired reagent container; lifting a desired reagent container by the gripper assembly; moving the gripper assembly with the desired reagent container to a loading position of the reagent server module by a transfer arm motor; positioning, by the gripper assembly, a desired reagent container into a particular indexing space of the one or more indexing spaces via a loading position; and opening a seal of a desired reagent container by the gripper assembly. The operation of the gripper assembly and transfer arm motor is controlled by the controller.

Drawings

The foregoing and other aspects of the present invention are best understood from the following detailed description when read with the accompanying drawing figures. For the purpose of illustrating the invention, there is shown in the drawings, embodiments which are presently preferred, it being understood, however, that the invention is not limited to the specific instrumentalities disclosed, and wherein:

FIG. 1 is a layout of an exemplary system architecture within which embodiments of the present invention may be implemented, according to an embodiment;

fig. 2 is an illustration of an exemplary reagent container according to an embodiment;

FIG. 3 is a diagram illustrating features of a reagent processing system according to embodiments herein;

FIG. 4 is an illustration of a gripper finger for use in a reagent processing system according to embodiments disclosed herein;

5-19 are a series of diagrams illustrating various aspects of use of a reagent processing system according to embodiments disclosed herein;

fig. 20A is a flow diagram illustrating a method of unloading a reagent container in a clinical analyzer in an In Vitro Diagnostic (IVD) environment, according to an embodiment;

fig. 20B is a flow diagram illustrating a method of loading reagent containers in a clinical analyzer in an In Vitro Diagnostic (IVD) environment, according to an embodiment;

fig. 20C is a flow diagram illustrating a method of opening reagent containers in a clinical analyzer in an In Vitro Diagnostic (IVD) environment, according to an embodiment; and

FIG. 21 illustrates an exemplary computing environment in which embodiments of the invention may be implemented.

Detailed Description

Embodiments relate to apparatus and methods for transferring and opening reagent containers for clinical or other analytical instruments in an In Vitro Diagnostic (IVD) environment in a hospital or laboratory setting. Since clinical analyzers typically include one or more reagent storage areas dedicated to storing and supplying respective ones of a plurality of reagent containers, there is a need to efficiently and safely transfer containers to the storage areas and open the containers. According to embodiments herein, the apparatus and method enable a desired unopened reagent container to be transferred by a mechanical mechanism. According to an embodiment, the contents of the reagent container may be automatically recorded and the container positioned and opened so that its contents are available for delivery of the probe. A set of mechanical fingers open and close relative to each other to release and grip reagent containers on opposite sides of the reagent containers for transport of the containers. According to an embodiment, once the receptacle is positioned, the mechanical fingers are raised and positioned over a seal concealing the contents of the reagent container. The fingers are configured to close together and travel in a downward trajectory to puncture the seal. In an embodiment, the reagent containers are initially presented as unopened packages to prevent spillage and to control reagent life expectancy to prevent evaporative oxidation, contamination, and premature aging. According to additional embodiments, methods for performing cyclic unloading, transferring and loading without operator intervention are provided, with specific details relating to the embodiments described in detail below.

Although the embodiments are described with respect to transferring reagent containers to and from a reagent storage area in a clinical analyzer, the invention is not so limited. The methods and apparatus provided herein may be extended by one of ordinary skill in the art to other types of containers, storage areas, analyzers, or systems.

Fig. 1 provides a layout of an exemplary system architecture 100 in which embodiments of the present invention may be implemented, according to an embodiment. In fig. 1 is shown: a plurality of transfer arms 110 (110 a, 110b, 110c, and 110 d) having respective probes; a dilution carousel 120 comprising a plurality of dilution containers arranged in one or more dilution rings; a reaction carousel 130 comprising a plurality of reagent containers disposed in one or more reaction rings; and reagent storage regions 140a and 140b dedicated to storing and supplying respective reagents, each reagent storage region 140a and 140b including a space for a plurality of reagent containers. In operation, the transfer arm 110a and its corresponding probe are operable to transfer a sample from an access location to one or more dilution containers on the dilution carousel 120 to produce a dilution therein. The transfer arm 110b and its corresponding probe are operable to transfer diluent from the diluent container to a reaction container on the reaction carousel 130. The transfer arms 110c and 110d and their corresponding probes are operable to transfer reagents from the reagent storage areas 140a and 140b, respectively, to reaction vessels on the reaction carousel 130. The various transfers occur through the use of a pumping mechanism (not shown), such as a displacement pump, attached to the transfer arm 110. In addition, the system architecture 100 includes one or more controllers (not shown) for controlling the operation of various components, including the transfer arm 110, the probe, and the carousel.

Also included in system architecture 100 is reagent processing system 300, the details of which are further described herein below with reference to fig. 3. The components of the reagent processing system 300 shown in the system architecture 100 of fig. 1 are the reagent server module 310, the gripper assembly 321, the horizontally extending transfer arm 350, and the tray 331.

The system architecture 100 of fig. 1 and the accompanying description describe, by way of example only and not by way of limitation, the transfer and open methods and apparatus disclosed herein. The system architecture 100 is merely one exemplary system in which the transfer and open methods and devices may be implemented.

Fig. 2 is an illustration of an exemplary reagent container 200 that may be used in conjunction with system architecture 100 and reagent processing system 300 (described in detail below). Other types of containers or variations of reagent containers 200 may be used, and the reagent processing system 300 is not limited to use with the example reagent containers 200 described herein. Detailed features of an exemplary reagent container 200 are provided in PCT patent application serial No. PCT/US14/019078, the contents of which are incorporated herein by reference in their entirety.

According to an embodiment, the reagent container 200 includes two storage portions (or packs) 210, 212 configured to hold reagent fluid for a particular on-board diagnostic test on a clinical analyzer (e.g., the system architecture 100). The reagent vessel 200 further comprises a lid 220, 222 for each pack 210, 212, respectively. The lids 220, 222 include seals 230, 232, respectively. The labels 240 may be provided and may include bar code labels 242 for inventory purposes. In an embodiment, the label 240 is positioned on one of the packs 210, 212 with the barcode label 242 positioned on the upper surface of the pack 210, 212 on which the label 240 is disposed. The barcode label 242 may be located on any surface of the one or more packets 210, 212 that is accessible by a barcode reader. The web-gripping portion 250 extends between the two storage packs 210, 212 and in embodiments is a substantially flat surface, which may have one or more projections or gripping portions provided thereon.

Turning to fig. 3, a reagent processing system 300 is shown according to embodiments provided herein. According to an embodiment, the reagent processing system 300 transfers one or more containers 200 to and/or from a clinical analyzer (e.g., reagent storage areas 140a and 140b of the system architecture 100 shown in fig. 1).

According to an embodiment, the reagent processing system 300 includes a reagent server module 310, a reagent transfer arm apparatus 320, and a reagent loading station 330. In an embodiment, the reagent server module 310 is a refrigerated storage enclosure that includes one or more indexing rings for storing reagent containers 200. The reagent transfer arm apparatus 320 provides linear transfer of reagent containers 200. The reagent loading station 330 is provided for loading and unloading one or more reagent containers 200.

In an embodiment, the reagent loading station 330 includes a tray 331 having one or more tray spaces 332. Each of the tray spaces 332 is configured to hold a respective reagent container 200. In another embodiment, the tray 331 is a flat surface with sufficient space for holding one or more reagent containers 200. According to an embodiment, the reagent loading station 330 further comprises a tray motor 333 coupled to the tray 331 and configured to move the tray 331 in a horizontal direction between the loading/unloading point and the one or more transfer points. In an embodiment, the loader rail 334 is a surface on which the tray 331 is held and moved.

In an embodiment, the reagent loading station 330, in particular the tray 331, is accessible (e.g. at a loading/unloading point) by an operator for manually loading the reagent container 200 to the tray 331 and manually unloading the reagent container 200 from the tray 331.

With continued reference to FIG. 3, a reagent transfer arm apparatus 320 is shown. The reagent transfer arm apparatus 320 comprises a gripper assembly 321 configured to grip the gripping portion 250 of each of the one or more reagent containers 200 one at a time and to move each of the one or more reagent containers 200 to and from a respective one of the one or more tray spaces 332, e.g. at a respective transfer point. In another embodiment, the reagent transfer arm apparatus 320 interfaces with an automated track system that can provide loading and unloading of reagent containers 200.

In an embodiment, gripper assembly 321 includes a pair of gripper fingers 322 that are vertically oriented and opposite one another. Fig. 4 is an illustration of an example gripper finger 322 for use in a reagent processing system 300, according to an embodiment. As shown in fig. 4, in an embodiment, each gripper finger 322 includes a support portion 323 that transitions into a narrower finger portion 324 having a tip 325 at an end portion thereof. The support portion 323 may include an aperture or slot for mounting to the reagent transfer arm apparatus 320. The pair of gripper fingers 322 is configured to move between a release (or open) position, in which the pair of gripper fingers 322 are separated relative to each other, and a gripping (or closed) position, in which the pair of gripper fingers 322 are urged together relative to each other. The tip 324 of each gripper finger 322 is a sharp point such that when the gripper fingers 322 are in the gripping position, the gripper fingers 322 are able to puncture the seals 230, 232 of the lids 220, 222 of the reagent containers 200.

In an embodiment, to facilitate gripping of the gripping portion 250 of the container 200 when in the gripping position, the gripper fingers 322 may include a plurality of sharp, pointed protrusions and recesses 326 on opposing surfaces at a distal end (e.g., near or adjacent to the tip 325), wherein the plurality of protrusions and recesses 326 on one of the pair of gripper fingers 322 are configured to mate with the plurality of opposing protrusions and recesses 326 on the other of the pair of gripper fingers 322. To further increase the friction between the fingers 322 and the container 200 to be gripped and transported, the distal end of one or more of the fingers 322 may include a high friction material, such as rubber.

Referring back to the reagent processing system 300 of fig. 3 (some of which are more clearly shown in the enlarged views of fig. 5-19), in addition to the gripper fingers 322, the gripper assembly 321 includes a gripper actuator 327 that includes a gripper motor coupled to the pair of gripper fingers 322 and configured to control the pair of gripper fingers 322 to move the pair of gripper fingers 322 between the release position and the gripping position (see also, e.g., fig. 5, 6, 7). A vertically extending frame 328 (see fig. 6) is provided to which the pair of gripper fingers 322 and gripper actuator 327 are movably coupled and along which the pair of gripper fingers 322 and gripper actuator 327 move in a vertical direction. A vertical drive motor 329 (see fig. 3) is configured to control vertical movement of the pair of gripper fingers 322 and gripper actuator 327 along a vertically extending frame 328. As described in detail below, the vertical movement of the pair of gripper fingers 322 provides: insertion and removal of one or more reagent containers 200 into and from the tray 331 and the reagent server module 310; and opening of the sealing members 230, 232 of the reagent vessel 200.

The gripper assembly 321 further comprises a barcode scanner 340 configured to read the barcode label 242 on the reagent container 200. In an embodiment, the barcode scanner 340 reads the barcode label 242 on the particular reagent container 200 when the particular reagent container 200 is moved to the transfer point (i.e., when the reagent container 200 is moved via the tray 331 to a point below the barcode scanner 340 or within range of the barcode scanner 340).

With continued reference to the reagent processing system 300 of fig. 3 and the more detailed views of fig. 5-19, the reagent transfer arm apparatus 320 further includes a horizontally extending transfer arm 350, the gripper assembly 321 is movably coupled to the transfer arm 350, and the gripper assembly 321 moves in a horizontal direction along the transfer arm. The transfer arm motor 352 is configured to control horizontal movement of the gripper assembly 321 along the horizontally extending transfer arm 350.

The reagent server module 310 portion of the reagent processing system 300 includes a storage enclosure including one or more indexing rings 318 having an indexing space 312 (see, e.g., fig. 6, 12, 13, 14 and 18) for holding one or more reagent containers 200. The indexing ring 318 divides storage of the containers 200 into incremental stations that serve as receptacle compartments and maintain the position and separation of the reagent containers 200. As shown (see, e.g., fig. 6 in greater detail), the indexing space 312 is a portion of the ring 318 that moves under the annular portions 140a, 140b of reagent storage, at which point reagent may be accessed for use in the system architecture 100.

In an embodiment, the reagent server module 310 includes a door 314 (see fig. 5 and 6) disposed on an upper portion of the storage enclosure that is configured to move between an open position in which an interior portion of the storage enclosure is accessible and a closed position in which the interior portion of the storage enclosure is inaccessible. In an embodiment, the door 314 is a slidable door having a door recess 316 configured to be slid open and closed by a gripper assembly 321, as further described below.

As shown in fig. 3, the horizontally extending transfer arm 350 of the reagent transfer arm arrangement 320 extends horizontally along the length of the reagent server module 310, and the length of the tray 331 is oriented perpendicular to the length of the horizontally extending transfer arm 350. Of course other physical configurations are possible and the reagent processing system 300 is not limited to the physical configuration shown in fig. 3.

In an embodiment, the reagent processing system 300 further comprises a washing and drying station 360 (see fig. 17) accessible by the gripper assembly 321 via horizontal movement of the gripper assembly 321 along the horizontally extending transfer arm 350. The cleaning and drying station 360 includes a rinse station 362 configured to rinse the holder fingers 322 and a drying station 364 configured to vacuum dry the holder fingers 322. The operation of the washing and drying station 360 is described below with reference to fig. 17.

In an embodiment, one or more controllers or processors may be part of a system architecture (e.g., system architecture 100) configured to control the operation of one or more motors and other components. In an embodiment, one or more controllers are provided to control the operation of the reagent loading station 330 (i.e., tray motor 333), gripper assembly 321 (i.e., gripper actuator 327 with gripper motor, vertical drive motor 329, barcode scanner 340), transfer arm motor 352, and one or more indexing rings 318 to provide transfer of one or more reagent containers 200 between the tray 331 and the one or more indexing rings 318. One or more controllers may be in communication with a local controller and/or a central controller.

In an embodiment, one or more of the motors (e.g., tray motor 333, gripper actuator 327 with gripper motor, vertical drive motor 329, and transfer arm motor 352) may be an encoder with a stepper motor.

Referring to fig. 5-19, reagent processing system 300 is shown at various points in the unloading, loading, and opening processes according to embodiments provided herein.

Fig. 5 shows the gripper fingers 322 inserted into a gripping (i.e., closed) position in the door recess 316 of the door 314. Once inserted, the transfer arm motor 352 operates to move the gripper assembly 321 horizontally along the horizontally extending transfer arm 350 to slide open the door 314.

Fig. 6 shows the door 314 in an open position, thereby exposing the interior of the reagent server module 310 (e.g., the ring 318 and the space 312). The indexing space 312 of the ring 318 is shown as empty and accessible. The gripper fingers 322 remain in the door recess 316. The reagent vessel 200 is positioned on the tray 331 in the tray space 332.

According to one embodiment, the reagent transfer arm gripper fingers 322 index to a release (i.e., open) configuration and move to a load/unload position above the reagent server ring 318. The gripper fingers 322 travel into the reagent server module 310 and grip reagent containers 200, which may be empty or need to be removed. According to an embodiment, the gripper fingers 322 close to create a pinch at opposite sides of the gripping part 250 of the reagent container 200, which gripping part is found between the lids 220, 222 of the reagent container 200. The reagent container 200 is lifted from the ring 3138 and moved to a discard station (not shown) or returned to the reagent loading station 330 (e.g., tray 331) for disposal by an operator.

After determining that a particular reagent needs to be replenished or added to the on-board inventory of one of the rings 318 (e.g., via the controller), the gripper assembly 321 is moved horizontally along the horizontally extending transfer arm 350 to the reagent loading station 330.

In an embodiment, the barcode scanner 340 scans the barcode label 242 of the reagent container 200 on the tray 331 to obtain the availability (i.e., method or recipe) of the reagent container 200 containing the desired reagent. The tray 331 is laterally indexed as the barcode scanner 340 scans for the presence of reagent containers 200 having barcode labels 242 that meet the requirements of the desired reagent. According to an embodiment, after detecting a barcode label 242 that meets the requirements, the reagent processing system 300, via one or more controllers, determines the position of the reagent container 200 in the ring 318. The ring 318 is then rotated by one of the one or more controls such that the position (i.e., the indexing space 312) is at a position equivalent to the loading/unloading position above the reagent server ring 318.

Referring to fig. 7, the gripper fingers 322 are positioned above (via the reagent transfer arm apparatus 320) the container 200 which is found on the tray 331 of the reagent loading station 330.

As shown in fig. 8, the gripper fingers 322 are indexed to the release position via the gripper motor of the gripper actuator 327.

As shown in fig. 9, the gripper fingers 322 travel vertically downward via the vertical drive motor 329 to a position in which the gripper fingers 322 are positioned on both sides of the gripping portion 250 of the reagent container 200. The gripper fingers 322 close to the gripping position to grip the gripping portion 250 of the reagent container 200.

As shown in fig. 10, gripper fingers 322 with gripped reagent containers 200 are lifted (via vertical drive motor 329).

Fig. 11 shows the part of the gripper assembly 321 with the gripped reagent container 200, which is moved via a transfer arm motor 352 along a horizontally extending transfer arm 350 into a loading/unloading position above the reagent ring 318.

Fig. 12-14 show the vertical downward arrangement of the gripper fingers 322 and the gripped reagent container 200 into the indexing space 312, which has previously been moved into position.

At some time after one or more of the reagent containers 200 are placed into the ring 318, the gripper assembly 321 operates to open one or more of the reagent containers 200. In an embodiment, the gripper fingers 322 are moved to a position above one of the lids 220, 222 of the reagent vessel 200.

Fig. 15 and 16 illustrate a seal opening process according to an embodiment. The gripper fingers 322 are closed together in the gripping position to form a sharp point to pierce the seal 232 of the lid 222 of the reagent container 200. The closed gripper fingers 322 are lowered and inserted into the lid 222, thereby puncturing the seal 232 with the sharp point formed by the closed gripper fingers 322 (see fig. 15). As shown in fig. 16, the gripper fingers 322 (which are still in the lid 222 at this time) move slightly apart within the limits of the opening of the lid 222 to spread the seal 232 to a more fully open position, thereby providing unobstructed access to the reagents contained in the reagent container 200 and reducing friction that would result in lifting of the container 200 when the gripper fingers 322 are withdrawn.

The gripper fingers 322 are closed and then lifted vertically and can be moved to a position above the other lid/seal 222/232 to puncture the seal 232 if desired or necessary. The second opening process may be delayed as controlled by one of the one or more controllers.

The gripper assembly 321 is vertically lifted from the reagent vessel 200 via a vertical drive motor 329 along a vertically extending frame 328 and moved to a washing and drying station 360 (see fig. 17) via a transfer arm motor 352 along a horizontally extending transfer arm 350. In an embodiment, the gripper fingers 322 are inserted downward into the rinse station 362 and rinsed as they are repeatedly moved between open and closed positions to ensure thorough cleaning. The gripper fingers 322 are then moved to a drying station 364 where they are vacuum dried (in an open position in one embodiment) prior to exiting.

As shown in fig. 18, the gripper fingers 322 are closed and the gripper assembly 321 is moved laterally into the door recess 316 into which the gripper fingers 322 are positioned to close the door 314. The gripper fingers 321 are moved laterally along a horizontally extending transfer arm 350 to move the door 314 to the closed position (see fig. 19).

Various connections, such as electrical connectors and the like, are also shown in the figures.

Fig. 20A is a flowchart 2000 illustrating a method of unloading a reagent container 200 in, for example, an IVD environment, according to an embodiment. The method uses various aspects of the reagent processing system 300 described herein.

At 2001, the gripper assembly 321 opens the door 314 of the reagent server module 310. At 2002, the gripper assembly 321 is moved to the tray 331 of the reagent loading station 330. In an embodiment, this may be the end position of the horizontally extending transfer arm 350. At 2003, the barcode scanner 340 scans the vacated space of the tray 331 as the tray 331 moves laterally along the tray track 334.

At 2004, the gripper assembly 321 moves to the reagent server module 310. At 2005, it is desired that the container 200 be gripped and lifted by the gripper assembly 321. At 2006, the gripper assembly 321 removes the desired container 200 from the reagent server module 310.

At 2007, the gripper assembly 321 moves back to the tray 331 to place the gripped container 200. At 2008, the container 200 is positioned in the empty space of the tray 331 that was previously identified during the scanning operation of 2003.

After determining at 2010 that there are no more containers 200 that need to be unloaded from the reagent server module 310, the door 314 is closed at 2009. Conversely, if it is determined at 2010 that there are containers 200 that need to be unloaded, the gripper assembly 321 moves back to the reagent server module at 2004 and the steps for moving unnecessary or empty reagent containers 200 are repeated. This process may occur until all of the reagent containers 200 that need to be removed for a given operation are removed and placed into the empty space of the tray 331.

Fig. 20B is a flow diagram 2020 illustrating a method of loading a reagent container 200 in, for example, an IVD environment, according to an embodiment. The method uses various aspects of the reagent processing system 300 described herein.

At 2021, the gripper assembly 321 opens the door 314 of the reagent server module 310. At 2022, the gripper assembly 321 moves to the tray 331 of the reagent loading station 330. At 2023, the barcode scanner 340 scans the tray 331 to locate the desired reagent container 200 as the tray 331 moves laterally along the tray track 334.

At 2024, the gripper assembly 321 grips and lifts the desired container 200. At 2025, the gripper assembly 321 moves the desired container 200 to the reagent server module 310. At 2026, the container 200 is positioned in the indexing space 312.

At 2027, a determination is made as to whether there are more containers 200 to load into the reagent server module 310. If additional loading is necessary, the process continues to 2024 where the gripper assembly 321 grips and lifts another desired container 200 from the tray 331 at 2024. However, if additional loading is not required at this time, the gripper assembly 321 closes the door 314 at 2028.

Fig. 20C is a flowchart 2030 illustrating a method of opening a reagent container 200 in, for example, an IVD environment, according to an embodiment. The method uses various aspects of the reagent processing system 300 described herein.

At 2031, the gripper assembly 321 opens the door 314 of the reagent server module 310. At 2032, the gripper assembly 321 moves to the reagent server module 310. At 2033, the gripper assembly 321 is lowered to the desired lid/seal 220/230, 222/232 of the container 200 and punctures the seal 230, 232.

At 2034, the gripper assembly 321 moves to the cleaning station 360. At 2035, the cleaning and drying of the gripper fingers 322 is performed.

At 2036, the gripper assembly 321 closes the door 314.

According to embodiments herein, a summary of a method of providing reagent fluid to an instrument inventory is as follows: the operator is prompted to load a new unexpired container 200 of the required reagent. The container 200 is scanned to verify the accuracy of the reagents. The gripper fingers 322 close and move into position and slide open the door 314 of the storage enclosure. The gripper fingers 322 move into a position above the reagent container 200, the fingers 322 open, and the fingers 322 move down into a position straddling the sides of the gripping portion 250 of the container 200. The gripper fingers 322 close to pinch the container gripping portion 250. The gripper fingers 322 lift the container 200 from the reagent loading station 330. The gripper assembly 321 transports the container 200 into position over the storage enclosure (i.e., ring 318) of the reagent server module 310. The reagent ring 318 is rotated to the vacated position and the gripper fingers 322 travel downward while continuously holding the containers 200 by the gripping portions 250 to place the containers 200 into the vacated reagent ring space 312. The gripper fingers 322 separate to an open position and this releases the container 200. The gripper fingers 322 travel upward and are removed from the frozen storage enclosure. The gripper fingers 322 then travel to the door recess 316 and reclose the storage sliding door 314. The gripper fingers 322, now in the retracted position, travel to the home position (waiting position) for the next transfer call from the manual operator or instrument automation (i.e., controller).

A method of opening the reagent vessel 200 is summarized as follows: when centered at the central aperture location of the lids 220, 222 of the container 200, the reagent holder fingers 322 travel up and linearly along the container location. The gripper fingers 322 close and form a bullet shape or point at the tip. The gripper fingers 322 move downward, pierce, and pass the seals 230, 232. When in the piercing position into the throat of the container 200, the gripper fingers 322 open to increase the open size of the seals 230, 232 and close to clear the container lids 220, 222 and seals 230, 232. The gripper assembly 321 travels to the gripper cleaning and drying station 360 for rinsing and drying the gripper fingers 322.

The methods and apparatus provided herein have a number of advantages. Advantageously, the methods and apparatus provided herein result in preventing loss of instrument use, resulting in increased overall volume for reagent sales. Automated methods and apparatus reduce field hazards and errors, as well as repetitive motion injuries to labor personnel. In addition, there is a reduction in testing and instrumentation time loss, as well as an increase in reagent life, usability, stability, and reliability.

According to embodiments provided herein, the method and apparatus provide for the inventory of certain supplies of reagents and removal for replacement of empty containers. By reducing the time required to separate an empty reagent container from the storage server, the efficiency of placement and opening of new reagent fluid containers is increased. The method and apparatus provide for efficient transport of containers and at the same time perform the loading process with high accuracy and improve the container removal process. Conveniently eliminating the need to perform container separation inventory processing in a manual "batching" format. Advantageously, the tests performed in the reaction zone are not interrupted by the reagent delivery and loading methods and apparatus provided herein.

Furthermore, by providing a continuous process for placing, opening and removal of the depleted reagent volume, the opening of the reagent container is improved. The availability of sufficient reagents for a defined test greatly reduces latency and increases test throughput.

In conventional systems in which manual loading and unloading of reagent containers is performed, the storage area is constantly opened and closed, the indexing operation is repeatedly stopped and restarted, and the loading process needs to be repeated as long as the reagent volume needs to be replenished. Thus, constant manual filling and emptying of the storage area wastes time and compromises the cooling effect, resulting in time and regulatory inefficiencies. However, according to the method and apparatus described herein, these disadvantages are mitigated by stabilizing and optimizing the climate of the storage area by reducing cooling losses. Thus, by minimizing reagent loss and/or evaporation of reagent due to temperature changes and fluctuations, the yield of the desired reagent is increased.

An additional benefit of the transfer and open methods and apparatus provided herein is that the amount of operator scanning errors is reduced.

Yet another benefit is an increased amount of reagent life, which is achieved by making the reagent available but not opening the reagent container until it is needed to wait for the test to be processed.

An additional benefit is that an efficient method of collecting inventory information is achieved by scanning the entire contents of the reagent server ring with a barcode scanner and recording the current inventory of on-board reagent pack recipes.

FIG. 21 depicts an exemplary computing environment 2100 within which embodiments of the invention may be implemented. The computing environment 2100 may include a computer system 2110, which is one example of a general purpose computing system on which embodiments of the present invention may be implemented. Computers and computing environments such as computer 2110 and computing environment 2100 are well known to those skilled in the art and are therefore described briefly herein.

As shown in FIG. 21, computer system 2110 can include a communication mechanism such as a bus 2121 or other communication mechanism for communicating information within computer system 2110. The system 2110 also includes one or more processors 2120 (e.g., the controllers described above, configured to control operation of the various components including the motor, barcode scanner, and ring) coupled with the bus 2121 for processing the information. Processor 2120 may include one or more Central Processing Units (CPUs), graphics Processing Units (GPUs), or any other processor known in the art.

Computer system 2110 also includes a system memory 2130 coupled to bus 2121 for storing information and instructions to be executed by processor 2120. The system memory 2130 may include computer-readable storage media in the form of volatile and/or nonvolatile memory such as Read Only Memory (ROM) 2131 and/or Random Access Memory (RAM) 2132. The system memory RAM2132 may include other dynamic storage devices (e.g., dynamic RAM, static RAM, and synchronous DRAM). The system memory ROM2131 may include other static storage devices (e.g., programmable ROM, erasable PROM, and electrically erasable PROM). In addition, the system memory 2130 may be used for storing temporary variables or other intermediate information during execution of instructions by the processor 2120. A basic input/output system 2133, containing the basic routines that help to transfer information between elements within the computer system 2110, such as during start-up, may be stored in the ROM 2131. RAM2132 may contain data and/or program modules that are immediately accessible to and/or presently being operated on by processor 2120. The system memory 2130 may additionally include, for example, an operating system 2134, application programs 2135, other program modules 2136, and program data 2137.

The computer system 2110 also includes a disk controller 2140 coupled to the bus 2121 to control one or more storage devices, such as a magnetic hard disk 2141 and a removable media drive 2142 (e.g., a floppy disk drive, an optical disk drive, a tape drive, and/or a solid state drive), for storing information and instructions. Storage may be added to computer system 2110 using an appropriate device interface (e.g., small Computer System Interface (SCSI), integrated Device Electronics (IDE), universal Serial Bus (USB), or FireWire).

The computer system 2110 can also include a display controller 2165 coupled to the bus 2121 to control a display or monitor 2166, such as a Cathode Ray Tube (CRT) or Liquid Crystal Display (LCD), for displaying information to a computer user. The computer system 2110 includes an input interface 2160 and one or more input devices, such as a keyboard 2162 and a pointing device 2161, for interacting with a computer user and providing information to the processor 2120. For example, pointer device 2161 may be a mouse, a trackball, or a pointer stick for communicating direction information and command selections to processor 2120 and for controlling cursor movement on display 2166. Display 2166 may provide a touch screen interface that allows input to supplement or replace communication of directional information and command selections by pointer device 2161.

The computer system 2110 may perform some or all of the process steps of embodiments of the invention in response to the processor 2120 executing one or more sequences of one or more instructions contained in a memory, such as the system memory 2130. Such instructions may be read into system memory 2130 from another computer readable medium, such as a hard disk 2141 or a removable media drive 2142. The hard disk 2141 may contain one or more data storage contents and data files used by embodiments of the present invention. Data storage content and data files may be encrypted to improve security. Processor 2120 may also be used in a multi-processing arrangement to execute one or more sequences of instructions contained in system memory 2130. In alternative embodiments, hard-wired circuitry may be used in place of or in combination with software instructions. Thus, embodiments are not limited to any specific combination of hardware circuitry and software.

As mentioned above, computer system 210 may include at least one computer-readable medium or memory for holding instructions programmed according to embodiments of the invention and for containing data structures, tables, records, or other data described herein. The term "computer-readable medium" as used herein refers to any medium that participates in providing instructions to processor 2120 for execution. Computer-readable media can take many forms, including but not limited to, non-volatile media, and transmission media. Non-limiting examples of non-volatile media include optical, solid state drives, magnetic disks, and magneto-optical disks, such as the hard disk 2141 or the removable media drive 2142. Non-limiting examples of volatile media include dynamic memory, such as system memory 2130. Non-limiting examples of transmission media include coaxial cables, copper wire and fiber optics, including the wires that comprise bus 2121. Transmission media can also take the form of acoustic or light waves, such as those generated during radio wave and infrared data communications.

The computing environment 2100 may also include a computer system 2110 that operates in a networked environment using logical connections to one or more remote computers, such as a remote computer 2180. The remote computer 2180 can be a personal computer (laptop or desktop), a mobile device, a server, a router, a network PC, a peer network device or other common network node, and typically includes many or all of the elements described above relative to the computer system 2110. When used in a network environment, the computer system 2110 may include a modem 2172 for establishing communications over the network 2171 (e.g., the Internet). The modem 2172 may be connected to the system bus 2121 via the user network interface 2170 or via another suitable mechanism.

Network 2171 may be any network or system known in the art, including the Internet, an intranet, a Local Area Network (LAN), a Wide Area Network (WAN), a Metropolitan Area Network (MAN), a direct connection or a serial connection, a cellular telephone network, or any other network or medium capable of facilitating communication between computer system 2110 and other computers (e.g., remote computing system 2180). The network 2171 may be wired, wireless, or a combination thereof. The wired connection may be implemented using ethernet, universal Serial Bus (USB), RJ-11, or any other wired connection known in the art. The wireless connection may be implemented using Wi-Fi, wiMAX and bluetooth, infrared, cellular networks, satellite or any other wireless connection method known in the art. Additionally, multiple networks may operate individually or in communication with each other to facilitate communications in the network 2171.

As described herein, various systems, subsystems, agents, managers and processes may be implemented using hardware components, software components and/or combinations thereof.

Although the present invention has been described with reference to the exemplary embodiments, the present invention is not limited thereto. It will be understood by those skilled in the art that many changes and modifications may be made to the preferred embodiment of the present invention and that such changes and modifications may be made without departing from the true spirit of the invention. It is therefore intended that the following appended claims be interpreted as covering all such equivalent variations as fall within the true spirit and scope of the invention.

Claims (18)

1. A reagent transfer arm apparatus in a clinical analyzer in an In Vitro Diagnostic (IVD) environment, the reagent transfer arm apparatus comprising:

a gripper assembly comprising:

a pair of vertically oriented and mutually opposed gripper fingers configured to move between a release position in which the pair of gripper fingers are separated with respect to each other and a gripping position in which the pair of gripper fingers are pushed together with respect to each other, wherein in said gripping position the pair of gripper fingers is configured to grip a portion of a reagent container;

a gripper actuator comprising a gripper motor coupled to the pair of gripper fingers and configured to control horizontal gripping motion of the pair of gripper fingers to move the pair of gripper fingers between the release position and the gripping position;

a vertically extending frame to which the pair of gripper fingers and the gripper actuator are movably coupled and along which the pair of gripper fingers and the gripper actuator move in a vertical direction; and

a vertical drive motor configured to control vertical movement of the gripper assembly along the vertically extending frame;

a horizontally extending transfer arm to which the gripper assembly is movably coupled and along which the gripper assembly moves in a horizontal direction; and

a transfer arm motor configured to control horizontal movement of the gripper assembly along a horizontally extending transfer arm;

wherein the one or more controllers are configured to control operation of the gripper actuator, gripper motor, vertical drive motor, and transfer arm motor to transfer the reagent container between an access point and a storage area for accessing the contents of the reagent container;

wherein a distal end of the pair of gripper fingers comprises a sharp point configured to pierce a seal in a lid of the reagent container when the pair of gripper fingers is in the gripping position.

2. The apparatus of claim 1, wherein the opposing surfaces of the pair of gripper fingers comprise a plurality of protrusions and recesses, wherein the plurality of protrusions and recesses on one of the pair of gripper fingers are configured to mate with a plurality of opposing protrusions and recesses on the other of the pair of gripper fingers.

3. The apparatus of claim 1, wherein the gripper assembly further comprises a barcode scanner configured to read a barcode label on the reagent container, wherein the one or more controllers are further configured to identify the contents of the reagent container based on the barcode label for use in transporting the reagent container to a storage area.

4. A reagent processing system in a clinical analyzer in an In Vitro Diagnostic (IVD) environment, the reagent processing system comprising:

a reagent loading station comprising a tray comprising one or more tray spaces for holding one or more reagent containers, each of the one or more reagent containers being configured to contain a reagent and comprising a gripping portion;

a reagent transfer arm apparatus comprising:

a gripper assembly configured to grip the gripping portion of each of the one or more reagent containers one at a time and move each of the one or more reagent containers into and out of a respective one of the one or more tray spaces;

a vertically extending frame to which the gripper assembly is movably coupled and along which the gripper assembly moves in a vertical direction;

a vertical drive motor configured to control vertical movement of the gripper assembly along a vertically extending frame;

a horizontally extending transfer arm to which the gripper assembly is movably coupled and along which the gripper assembly moves in a horizontal direction; and

a transfer arm motor configured to control horizontal movement of the gripper assembly along the horizontally extending transfer arm;

a reagent server module comprising a storage enclosure comprising one or more indexing rings comprising an indexing space for holding the one or more reagent containers; and

one or more controllers configured to control operation of the reagent loading station, gripper assembly, vertical drive motor, transfer arm motor and one or more indexing rings to provide transfer of the one or more reagent containers between the tray and the one or more indexing rings;

wherein the horizontally extending transfer arm of the reagent transfer arm apparatus extends horizontally along the length of the storage enclosure;

wherein the length of the tray is oriented perpendicular to the length of the horizontally extending transfer arm, wherein the gripper assembly comprises a pair of vertically oriented and mutually opposed gripper fingers, the distal ends of the pair of gripper fingers comprising a sharp point configured to pierce a seal in a lid of the reagent container when the pair of gripper fingers is in a gripping position.

5. The system of claim 4, wherein the gripper assembly comprises: (i) Said pair of vertically oriented and mutually opposed gripper fingers configured to move between a release position in which the pair of gripper fingers are separated with respect to each other and a gripping position in which the pair of gripper fingers are pushed together with respect to each other, wherein in said gripping position the pair of gripper fingers is configured to grip a gripping portion of each of said one or more reagent containers; and (ii) a gripper actuator comprising a gripper motor coupled to the pair of gripper fingers and configured to control horizontal gripping motion of the pair of gripper fingers to move the pair of gripper fingers between the release position and the gripping position.

6. The system of claim 4, wherein vertical movement of the pair of gripper fingers provides insertion and removal of the one or more reagent containers into and from the tray and the one or more indexing rings.

7. The system of claim 4, wherein the reagent loading station further comprises:

a tray motor configured to move the tray in a horizontal direction between a loading point and one or more transfer points, each of the one or more transfer points corresponding to a respective one of the one or more tray spaces; wherein the movement of each of the one or more reagent containers effected by the gripper assembly is into and out of a respective one of the one or more transfer points; and

a loader rail comprising a surface on which the pallet is held and moved.

8. The system of claim 4, wherein each of the one or more reagent containers includes a barcode label thereon;

wherein the gripper assembly comprises a barcode scanner configured to read a barcode label on each of the one or more reagent containers, wherein the one or more controllers are further configured to identify the contents of a particular reagent container based on the respective barcode label and to deliver the particular reagent container to a particular indexing space on one of the one or more indexing rings.

9. The system of claim 4, wherein the reagent server module further comprises a door on an upper portion of the storage enclosure, the door configured to move to an open position in which an interior portion of the storage enclosure is accessible and a closed position in which the interior portion of the storage enclosure is inaccessible.

10. The system of claim 9, wherein the door includes a slide configured to be moved to the open position and the closed position by the gripper assembly.

11. The system of claim 4, further comprising a cleaning station accessible by the gripper assembly via horizontal movement of the gripper assembly along the horizontally extending transfer arm, the cleaning station comprising a rinsing station configured to rinse the gripper assembly and a drying station configured to vacuum dry the gripper assembly.

12. A method of processing reagent containers in a clinical analyzer in an In Vitro Diagnostic (IVD) environment, the method comprising:

identifying, by a controller, a need for a particular reagent to be added to a reagent server module, the reagent server module including one or more indexing rings having one or more indexing spaces;

moving a gripper assembly to a reagent loading station by a transfer arm motor configured to control horizontal and vertical movement of the gripper assembly along a horizontally and vertically extending transfer arm, the reagent loading station comprising a tray having one or more tray spaces for holding one or more reagent containers, each of the one or more reagent containers configured to contain a reagent and comprising a gripping portion, the gripper assembly configured to grip the gripping portion of each of the one or more reagent containers;

scanning, by a barcode scanner on the gripper assembly, a barcode label on each of the one or more reagent containers in the tray until a desired barcode label is identified, the desired barcode label corresponding to a particular reagent and being affixed to a desired reagent container;

lifting a desired reagent container by the gripper assembly;

moving the gripper assembly with the desired reagent container to a loading position of the reagent server module by a transfer arm motor;

positioning, by the gripper assembly, a desired reagent container into a particular indexing space of the one or more indexing spaces via a loading position; and

opening a seal of a desired reagent container by the gripper assembly;

wherein operation of the gripper assembly and transfer arm motor is controlled by the controller;

wherein the gripper assembly comprises: (i) A pair of vertically oriented and mutually opposed gripper fingers configured to move between a release position in which the pair of gripper fingers are separated with respect to each other and a gripping position in which the pair of gripper fingers are urged together with respect to each other, wherein in said gripping position the pair of gripper fingers is configured to grip a gripping portion of each of the one or more reagent containers; (ii) A gripper actuator comprising a gripper motor coupled to and configured to control the pair of gripper fingers to move the pair of gripper fingers between the release position and the gripping position; (iii) A vertically extending frame along which the pair of gripper fingers and the gripper actuator move in a vertical direction; and (iv) a vertical drive motor configured to control vertical movement of the pair of gripper fingers and the gripper actuator along the vertically extending frame, wherein a distal end of the pair of gripper fingers comprises a sharp point configured to pierce a seal in a lid of the reagent container when the pair of gripper fingers is in the gripping position.

13. The method of claim 12, wherein during scanning by the barcode scanner, the tray is laterally indexed along a loader track, the loader track including a surface on which the tray is held and moved, the laterally indexing including moving the tray by a tray motor controlled by the controller such that one of the one or more tray spaces is aligned with the barcode scanner at the transfer point.

14. The method of claim 12, further comprising:

removing unwanted reagent containers from the reagent server module by the gripper assembly.

15. The method of claim 12, further comprising:

opening a slidable door of the reagent server module by the gripper assembly prior to moving the gripper assembly to the reagent loading station; and

closing a slidable door of the reagent server module by the gripper assembly after opening the seal of the desired reagent container;

wherein opening and closing the slidable door of the reagent server module comprises: the slidable door is slid with a pair of gripper fingers of the gripper assembly configured to move between a release position in which the pair of gripper fingers are spaced apart relative to each other and a gripping position in which the pair of gripper fingers are urged together relative to each other.

16. The method of claim 12, wherein opening a seal of a desired reagent container by the gripper assembly comprises:

closing the pair of gripper fingers into the gripping position by the gripper actuator;

lowering the pair of gripper fingers by the vertical drive motor to puncture a seal of the desired reagent container; and

the pair of gripper fingers are opened to a slightly open position by the gripper actuator to spread apart the seal.

17. The method of claim 12, wherein lifting the desired reagent container by the gripper assembly comprises:

opening the pair of gripper fingers into a release position by a gripper actuator, the gripper actuator comprising a gripper motor on a gripper assembly comprising a pair of gripper fingers, the pair of gripper fingers configured to move between a release position in which the pair of gripper fingers are separated relative to each other and a gripping position in which the pair of gripper fingers are urged together relative to each other;

lowering the pair of gripper fingers to a desired reagent container by a vertical drive motor configured to control vertical motion of the pair of gripper fingers and the gripper actuator along a vertically extending frame along which the pair of gripper fingers and the gripper actuator move in a vertical direction;

gripping a desired reagent container by the pair of gripper fingers by closing the pair of gripper fingers into a gripping position at a gripping portion of the desired reagent container; and

the pair of gripper fingers is lifted together with the desired reagent container by a vertical drive motor.

18. The method of claim 12, further comprising:

moving the gripper assembly to a cleaning station by the transfer arm motor;

lowering the gripper assembly into the wash station by a vertical drive motor to receive a rinse solution, the vertical drive motor configured to control vertical movement of the gripper assembly along a vertically extending frame; and

the gripper assembly is lifted out of the cleaning station by a vertical drive motor.