Reagent test kit

Abstract

A box for arranging and loading reagent containers into a staining apparatus comprises: a housing having a base and walls upstanding from the base to define a plurality of compartments. Each compartment is configured to receive a reagent container. The housing comprises two portions pivotally coupled together at their respective first ends and configured to pivot between an open configuration and a closed configuration. When the box is loaded into the staining apparatus, each portion of the housing in the closed configuration is received in a corresponding one of a pair of adjacent channels within the staining apparatus.

Description

Technical Field

[0001] The present invention relates to a kit, and more particularly, to a kit for arranging and loading reagents on an automatic staining device for processing a tissue sample set on a slide. Background Art

[0002] Instruments for automatically processing biological samples (e.g., anatomical pathology samples) are well known. Processing can include typical types of staining procedures in immunochemistry, in situ hybridization, special staining, and cytology. The automation of some staining procedures has increased the speed at which pathological tests can be completed, achieving earlier diagnosis, and in some cases, achieving intervention. Staining is usually performed on samples placed on microscope slides to highlight certain histological features in biological samples, and samples are usually cultivated with a small amount of reagents. In many cases, the automatic staining of samples involves the manipulation of a mechanical arm to deliver aliquots of reagents to achieve staining.

[0003] In an example using an existing automated staining apparatus, a tissue sample is placed on a slide and moved to a slide processing module of the apparatus for processing with reagents. Here, processing of the sample is performed automatically by one or more robots configured to dispense reagents to the sample on the slide in a predetermined order according to a staining protocol.

[0004] It is desirable to increase the throughput of samples on slides through automated staining equipment, but this is often hampered by a number of factors. For example, in the case of test kits, operator error often results in insufficient or incorrect numbers of reagent containers being loaded into the test kit, or indeed, reagent containers being loaded into the test kit in the wrong position or in the wrong orientation, making it impossible for the staining equipment to correctly identify the reagent containers. Furthermore, these errors can be compounded when more than one test kit needs to be loaded into the staining equipment.

[0005] The present invention seeks to provide a kit which will overcome or substantially ameliorate at least some of the deficiencies of the prior art, or at least provide an alternative.

[0006] The reference herein to a patent document or other matter cited as prior art is not to be taken as an admission that the document or matter was known or that the information it contained was part of the common general knowledge as at the priority date of any claim. Summary of the invention

[0007] According to a first aspect of the present invention, there is provided a box for arranging and loading reagent containers into a staining device, the box comprising: a shell having a base and walls upright from the base to define a plurality of compartments, each compartment being configured to receive a reagent container, wherein the shell comprises two shell portions pivotally connected together at their respective first ends and configured to pivot between an open configuration and a closed configuration, and wherein, when the box is loaded in the staining device, each shell portion of the shell in the closed configuration is receivable in a corresponding one of a pair of adjacent channels located in the staining device.

[0008] Preferably, each housing part comprises, at the location of each compartment, an aperture extending substantially through its wall to at least partially receive a corresponding projection of a reagent container received in the compartment to ensure that the reagent container is correctly placed in the compartment.

[0009] Preferably, the wall of each housing part is a side wall and wherein, when the housing is in the closed configuration, the aperture associated with only one of the two housing parts faces outwards.

[0010] Preferably, each reagent container comprises a lid pivotably coupled to a wall of the reagent container, and the cassette is configured such that the lids of those reagent containers received in compartments associated with both housing parts can be opened only when the housing is in the open configuration.

[0011] Preferably, the cassette further comprises locking means to lock the two housing parts in position when the housing is in the closed configuration.

[0012] Preferably, the locking means is located at a respective second end of each of the two housing parts.

[0013] In one embodiment, the locking means takes the form of a snap-fit ​​arrangement wherein the second end of one housing portion comprises a cantilevered hook and the second end of the other housing portion comprises a complementary recess configured to receive the cantilevered hook when the housing is in the closed configuration.

[0014] Preferably, when the housing is in the closed configuration, the two housing parts are spaced apart from each other by a predetermined distance corresponding to the spacing between a pair of adjacent channels within the dyeing apparatus.

[0015] Preferably, the base extends outwardly from opposite lateral side walls of the shell to define a pair of flanges so that when the shell is in a closed configuration, the flange of each shell portion can be slidably received by a corresponding pair of laterally opposed alignment guides that are associated with each of a pair of adjacent channels located within the staining device when the box is substantially loaded within the staining device.

[0016] Preferably, at least one of the two housing portions includes a recess configured to receive a spring-biased brake pin, the movement of which is actuated by an electromagnetic lock associated with the dyeing device to substantially lock the box in an appropriate position within the dyeing device when the box is substantially loaded within the dyeing device.

[0017] Preferably, the recess is located at the first end of the at least one housing portion.

[0018] Preferably, the recess extends through a portion of a base associated with the at least one housing portion.

[0019] Preferably, the box also includes a handle to facilitate loading and unloading the box into and from the dyeing device.

[0020] Preferably, a handle is located at the second end of the housing portion having the recess at the first end.

[0021] In one embodiment, the handle includes a display panel for displaying identifiers associated with the identities of the plurality of reagent containers loaded within its compartments.

[0022] Preferably, the cassette further comprises locking means to lock the two housing parts in position when the housing is in the open configuration.

[0023] Preferably, the locking means is located at a respective first end of each of the two housing parts.

[0024] In one embodiment, the locking means takes the form of a snap-fit ​​arrangement wherein a first end of one housing portion comprises a cantilevered hook and a first end of the other housing portion comprises a complementary lip configured to engage the cantilevered hook when the housing is in the open configuration.

[0025] Preferably, each channel of a pair of adjacent channels within the staining apparatus comprises a sensor configured to determine the presence of a corresponding one of the two housing parts when the cartridge is loaded into the staining apparatus and the housing is in a closed configuration.

[0026] Preferably, when the box is loaded into the staining device, each compartment of the housing is positioned at a predetermined position within the staining device so that a probe associated with the staining device can be inserted in a precisely positioned manner through an opening of a reagent container received in each compartment to remove reagents therefrom.

[0027] Preferably, the housing is made of an engineering polymer selected from the group consisting of acrylonitrile butadiene styrene (ABS), polypropylene (PP), high density polyethylene (HDPE), polycarbonate (PC), polyvinyl chloride (PVC) and polytetrafluoroethylene (PTFE).

[0028] In one embodiment, the housing is made of stainless steel.

[0029] Preferably, a wall defining each compartment of the plurality of compartments includes at least one rib to provide a friction fit with the reagent container when the reagent container is received in the compartment.

[0030] Preferably, the base includes a drainage hole located at the location of each compartment of the plurality of compartments.

[0031] Other aspects of the invention are also disclosed. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Although any other forms may fall within the scope of the present invention, preferred embodiments of the present invention will now be described by way of example only with reference to the accompanying drawings, in which:

[0033] Figure 1 shows a perspective view of a kit according to a preferred embodiment of the present invention, wherein the kit is shown in a partially opened configuration when viewed from the front;

[0034] Figure 2 Shown when viewed from behind Figure 1 A stereoscopic view of a kit of FIG.

[0035] Figure 3 Shown in a closed configuration when viewed from the front Figure 1 A stereogram of a kit of

[0036] Figure 4 Shown in a closed configuration when viewed from behind Figure 3 A stereogram of a kit of

[0037] Figure 5 Shows Figure 1 A perspective view of a kit of , wherein the kit is shown in an open configuration when viewed from the front;

[0038] Figure 6 Shows Figure 1 A perspective view of a reagent box of , wherein the reagent box is shown in an open configuration when viewed from the rear;

[0039] Figure 7 Shown in closed configuration Figure 1 A bottom view of a kit of

[0040] Figure 8 Shown in closed configuration Figure 1 A plan view of the kit;

[0041] Fig. 9 Shown in closed configuration Figure 1 A side view of a kit of

[0042] Fig.10 Shown in closed configuration Figure 1 A side view of a kit of

[0043] Fig.11 Shown in open configuration Figure 1 A perspective view of a hinge portion of a kit;

[0044] Fig.12 Shown in a closed configuration when viewed from the front Figure 1 An end view of a reagent kit;

[0045] Fig.13 Shown in a closed configuration when viewed from behind Figure 1 an end view of a kit of; and

[0046] Fig.14 shows the receiving Figure 1 A three-dimensional image of an automated staining apparatus for one or more reagent kits; and

[0047] Fig.15 Shows Figure 1 A three-dimensional view of a reagent kit comprising a plurality of reagent containers loaded into a corresponding one of the plurality of compartments of the reagent kit. DETAILED DESCRIPTION

[0048] It should be understood that the following description is only for the purpose of describing particular embodiments, and that the above description is not intended to be limiting.

[0049] The present invention is based on the discovery of a kit 10 for arranging and loading reagent containers into a staining apparatus, such as Fig.14 As shown, the reagent kit 10 includes two separate reagent kits, which are pivotally coupled together at first ends thereof and are configured to occupy a pair of adjacent channels 510 associated with the staining device 500, which are generally used to receive the two separate reagent kits.

[0050] Due to this arrangement, it is possible to provide a test kit 10 that includes more than the standard number of compartments associated with a single test kit, so that any reagent containers provided as part of a kit (e.g., a detection kit) can be packaged and sold together as a single item. In this regard, the various reagents associated with the kit can be preloaded into predetermined compartments within the housing of the test kit 10, making it easier for the automatic staining device 500 to identify that the correct number of reagent containers have been loaded into the device 500 in the correct order.

[0051] Kits in kit form can also be used to provide registered and / or validated reagents for use by customers such as the U.S. Food and Drug Administration (FDA), thereby providing a regulatory validated system.

[0052] As an example, Fig.14 The staining apparatus 500 shown may be a Leica Biosystems TM The BOND-III fully automated IHC and ISH stainer is available in the form of a DS9800 Bonded Polymer Refinement Detection Kit, DS9390 Bonded Polymer Refinement Red Detection Kit, or DS9477 ChromoPlex 1 Bonded Dual Detection Kit.

[0053] The following is a detailed description of a reagent kit 10 according to a preferred embodiment of the present invention, which is configured to arrange and load reagent containers into a Fig.14 The staining apparatus 500 is shown associated with a pair of adjacent channels 510.

[0054] case

[0055] like Figures 1 to 10 As shown, the reagent kit 10 comprises a housing in the form of two housing parts 100, 200 which are pivotally coupled together at their respective first ends by a hinge mechanism. The two housing parts 100, 200 are ideally made of a material resistant to chemicals associated with slide staining equipment.

[0056] For example, in one embodiment, the two housing portions 100 , 200 are made from an engineering polymer using a suitable manufacturing process, such as injection molding.

[0057] Preferred engineering polymers are selected from the group consisting of acrylonitrile-butadiene-styrene (ABS), high density polypropylene (HDPP), high density polyethylene (HDPE), polycarbonate (PC), polyvinyl chloride (PVC) and polytetrafluoroethylene (PTFE).

[0058] The first housing portion 100 includes a base 110, a pair of side walls 120, 130, a pair of end walls 140, 150, and a plurality of partition walls 160, 165, 170, 175, all of which are upstanding from the base 110 to define a plurality of compartments (indicated by the general reference numerals Xa-Xe). Each compartment Xa-Xe is configured to receive a reagent container, such as Fig.15 Reagent containers shown loaded into compartments Xa-Xe. The two lateral side walls 120, 130 each have a respective lip 125, 135 extending outwardly from an upper portion of the respective side wall 120, 130 at an angle of approximately 90 degrees relative to the side wall 120, 130.

[0059] like Figures 1 to 6 and Figure 8As shown, at the position of a corresponding one of the multiple compartments Xa-Xe of the first shell part 100, a series of numbers "1, 2, 3, 4 and 5" are marked on the upper surface of each lip 125, 135, serving as visual identifiers of reagent containers that can be loaded into each compartment Xa-Xe.

[0060] In order to ensure a friction fit relative to the reagent container when the reagent container is received in the compartment Xa-Xe, one or more of the side walls 120, 130, end walls 140, 150 and partition walls 160, 165, 170, 175 defining the multiple compartments Xa-Xe include at least one rib extending inwardly relative to the compartment Xa-Xe so as to tightly engage with the corresponding wall of the reagent container.

[0061] Meanwhile, the second housing portion 200 includes a base 210, a pair of side walls 220, 230, a pair of end walls 240, 250, and a plurality of partition walls 260, 265, 270, 275, all of which are upstanding from the base 210 to define a plurality of compartments (indicated by the general reference numerals Xf-Xj), wherein each compartment Xf-Xj is configured to receive a reagent container, e.g. Fig.15 Reagent containers shown loaded into compartments Xf-Xj. The two lateral side walls 220, 230 each have a respective lip 225, 235 extending outwardly from an upper portion of the respective side wall 220, 230 at an angle of approximately 90 degrees relative to the side wall 220, 230.

[0062] like Figures 1 to 6 and Figure 8 As shown, at the location of a corresponding one of the multiple compartments Xf-Xj, a series of numbers "6, 7, 8, 9 and 10" are marked on the upper surface of each lip 225, 235, serving as a visual identifier of the reagent container that can be loaded into each compartment Xf-Xj.

[0063] Similarly, in order to ensure a friction fit relative to the reagent container when the reagent container is received in the compartment Xf-Xj, one or more of the side walls 220, 230, end walls 240, 250 and partition walls 260, 265, 270, 275 defining the multiple compartments Xf-Xj include at least one rib extending inwardly relative to the compartment Xf-Xj so as to tightly engage with the corresponding side wall of the reagent container.

[0064] For example, Figure 1 As shown, the second housing portion 200 includes a generally rectangular portion 280 extending outwardly from the end wall 250. The portion 280 is generally about half the width of the second housing portion 200 and is located adjacent the side wall 230 of the second housing portion 200.

[0065] Extending outwardly from what would be considered an inwardly facing surface of portion 280 is a projection with a cantilevered hook 285 mounted to one side of the projection when the housing is in the closed position.

[0066] As will be described in more detail below, the cantilever hook 285 forms part of a locking mechanism to lock the two housing parts 100, 200 together when the housing is in the closed configuration.

[0067] In addition, if Figure 2 , Figures 4 to 6 and Fig.10 As shown, the side wall 130 of the first shell portion 100 and the side wall 230 of the second shell portion 200 both include generally circular holes (indicated by the general reference numerals Aa-Aj) that extend substantially through the side walls 130, 230 at the location of a corresponding one of the plurality of compartments Xa-Xj.

[0068] For example, Figure 1 , Figure 3 and Figure 5 As shown, the generally circular holes Aa-Ae extending through the side wall 130 of the first housing portion 100 are each positioned to at least partially receive a corresponding protrusion, extension or ball (not shown) extending outward from one of the side walls of the reagent container that has been loaded into the corresponding compartment Xa-Xe. The protrusion provides a tactile indicator for the operator to indicate that the reagent container is correctly oriented in the compartment Xa-Xe. A series of numbers "1, 2, 3, 4 and 5" are marked on the outer surface of the side wall 130 above the position of the corresponding one of the holes Aa-Ae, which are used as visual identifiers of the reagent containers that can be loaded into each compartment Xa-Xe.

[0069] Likewise, located beneath each of these generally circular apertures Aa-Ae is a generally rectangular aperture (not shown) also positioned to at least partially receive a corresponding projection (not shown) extending outwardly from the same side wall of a reagent container that houses compartments Xa-Xe. Figure 5 As shown, the rectangular aperture extending through the side wall 130 of the first housing portion 100 is concealed by a panel 180, which may be used, for example, for labeling and / or identification purposes.

[0070] Similarly, if Figure 2 , Figure 4 and Figure 6As shown, the roughly circular holes Af-Aj of these extending through the sidewall 230 of the second housing part 200 are positioned to receive at least partially a corresponding projection, extension or ball (not shown) extending outwards from the sidewall of the reagent container that has been loaded into the corresponding compartment Xf-Xj. This projection provides a tactile indicator for the operator to correctly orient the reagent container in the compartment XI-Xj. Similarly, on the outer surface of the sidewall 230, a series of numbers "6, 7, 8, 9 and 10" are marked above the position of a corresponding one in the hole Af-Aj, which is used as a visual identifier of the reagent container that can be loaded into each compartment Xf-Xj.

[0071] Whilst the generally rectangular apertures Bf-Bj are positioned to at least partially receive, and optionally lock, a container in place, a corresponding protrusion (not shown) may extend outwardly from the same side wall of a reagent container as that which loads into that compartment Xf-Xj.

[0072] This arrangement ensures that each reagent container is correctly placed (i.e., oriented) in the corresponding compartments Xa-Xj of the first housing portion 100 and the second housing portion 200. This is important because when the test kit 10 is loaded into the dyeing device 500, each compartment Xa-Xj is located at a predetermined position in the dyeing device 500, so that the probe (not shown) associated with the dyeing device 500 can be controlled by software to locate the opening of a specific reagent container received in one of the compartments Xa-Xj in a positionally accurate manner, wherein the software-controlled probe can then enter through the opening to remove the reagent from the reagent container. In fact, if the opening at the top of the reagent container is not centered, an incorrectly oriented reagent container may mean that the opening is not located at the specific coordinates that the software is programmed to cause the probe to move to.

[0073] like Figure 3 and Figure 4 As shown, only the generally circular apertures Af-Aj and the generally rectangular apertures Bf-Bj associated with the second housing portion 200 face outward when the housing is in the closed configuration.

[0074] Drainage holes

[0075] like Figure 7 and Figure 8 As shown, the bases 110, 210 for the first housing portion 100 and the second housing portion 200 each include a plurality of drainage holes (indicated by the general reference numeral Da-Dj) with holes Da-Dj at the location of each of the plurality of compartments Xa-Xj.

[0076] Flange

[0077] For example, Figures 1 to 6As shown, the bases 110, 210 for the first shell portion 100 and the second shell portion 200 extend outward from the relative lateral side walls 120, 130 and 220, 230 of the corresponding shell portions 100, 200 to define a pair of laterally opposite flanges 110f, 110g and 210f, 210g, so that when the shell is in a closed configuration, the flanges 110f, 110g and 210f, 210g of each portion 100, 200 of the shell can be slidably received by a corresponding pair of laterally opposite alignment guides (not shown), which are associated with each of a pair of adjacent channels 510 located within the staining device 500 when the reagent kit 10 is basically loaded inside the staining device.

[0078] handle

[0079] The reagent kit 10 further includes a handle 300 for facilitating loading and unloading the reagent kit 10 into and from a pair of adjacent channels 510 of the staining apparatus 500 .

[0080] Those of ordinary skill in the relevant art will appreciate that handle 300 may take any form.

[0081] In one embodiment, if Figures 1 to 10 As shown, the handle 300 takes the form of a generally rectangular body 320 having a central cavity 325 defined by a wall 322 of the body 320, a downwardly sloping surface 324, and a generally vertical rear surface 326, wherein the two surfaces 324, 326 converge to define an opening 325A, thereby allowing any fluid captured within the cavity 325 to drain.

[0082] Disposed between the handle 300 and the end wall 150 of the first housing portion 100 is a generally rectangular hollow body portion 330 oriented generally orthogonally relative to the longitudinal axis of the first housing portion 100, such as Figure 2 and Figure 5 As shown, approximately 30-50% of the body portion 330 extends beyond the side wall 120 toward the inwardly facing side of what may be considered the first housing portion 100 when the housing is in the closed configuration. Figure 7 As shown, the dimensions of the main body portion 330 are complementary to the smaller dimensions of the portion 280 located at the second end of the second housing portion 200 .

[0083] As will be described in more detail below, and as Figure 2 and Figure 5As shown, the body portion 330 also includes a recess 330A that extends at least partially through what will be considered the inwardly facing end of the body portion 330 when the housing is in the closed configuration. The recess 330A is internally configured with a lip (not shown) that is complementary to the cantilevered hook 285 that extends outwardly from the inwardly facing surface of the portion 280, whereby the recess and the cantilevered hook 285 constitute complementary parts of the same locking mechanism, as described in more detail below.

[0084] The handle 300 extends outwardly from approximately 30-50% of the main body portion 330. With this structure, when the housing is in a closed configuration, the handle 300 is positioned along a longitudinal axis that extends approximately midway between the compartments Xa-Xe of the first housing portion 100 and the compartments Xf-Xj of the second housing portion 200.

[0085] like Figures 1 to 6 , Fig. 9 and Fig.10 As shown, the handle 300 includes a display panel 350 for displaying identifiers (not shown) associated with the identities of any reagent containers that have been preloaded into the plurality of compartments of the reagent cartridge 10 in kit form.

[0086] Other identifiers may also be provided or located in relation to the reagent kit 10, such as labels including any form of barcodes, QR codes, or other identifiers, such as RFID readers or any such reading and / or writing devices may provide identification of the reagent kit 10 or reagent containers located therein, either by machine or otherwise. These identifiers may provide inventory information to the apparatus 500, and may also be used for tracking, inventory management, quality assurance of reagents, expiration management, or other such information associated with the reagent kit 100 with and without reagent containers.

[0087] In the case of a reagent, a machine-readable code encoding its unique consumable code may be printed on a label applied to a portion of the reagent kit 10 (the reagent container), or directly on the reagent container and / or the outer surface of the reagent kit 10. The reagent's machine-readable code may encode a batch number, reagent type, volume, etc., and may be read by the device 500 during use (or the container may include two machine-readable codes, one of which may be scanned by a user device (not shown) and one of which may be scanned by the device 500 during use).

[0088] In the case of a reagent kit comprising a plurality of reagent containers, the machine-readable code of the unique consumable code of the coding kit can be printed on a label applied to the kit carrier or directly printed on the kit carrier. The machine-readable code for the reagent kit can be based on the machine-readable code for each reagent container in the reagent kit. For example, the machine-readable code for the reagent kit can include a coding combination of the information in each machine-readable code of the reagent container encoded in the reagent kit.

[0089] The display panel 350 is defined by an elongated sheet member 352 having approximately the same width as the handle 300 and extending upward from the rear surface 326 of the handle 300 at an angle of approximately 45 degrees relative to the orientation of the main body 320 of the handle 300. The sheet member 352 is then folded back substantially approximately 90 degrees onto itself to define a generally flat rectangular surface forming a display surface 355 of the display panel 350. The sheet member 352 is then folded again approximately 90 degrees before extending downward to the upper surface of the generally rectangular main body portion 330. The resulting display panel surface 355 can be used to attach or print a bar code, a QR code, an RFID tag, etc., for marking the cartridge 10, for example, with an identifier of a kit including a plurality of reagent containers loaded into compartments Xa-Xj.

[0090] Hinge

[0091] Those of ordinary skill in the relevant art will appreciate that the hinge mechanism may take any form.

[0092] For example, in one embodiment, the hinge mechanism takes the form of a barrel hinge arrangement.

[0093] In particular, if Figure 2 , Figure 4 , Figure 5 , Fig. 9 and Fig.10 As shown, and more closely as Fig.11 As shown, the second housing portion 200 includes a generally triangular hollow bracket 290 truncated at its upper portion, which is formed at the first end of the second housing portion 200. The bracket 290 extends above the height of two lips 225, 235, which extend outwardly from the upper portion of a respective one of the two lateral side walls 220, 230. Extending outwardly from what can be considered as the inwardly directed corners of the bracket 290 is a pair of spaced apart barrels 292, 295. The angle at which the barrels 292, 295 extend from the corners ensures that the barrels 292, 295 are eccentrically positioned relative to the longitudinal axis of the first housing portion 100.

[0094] The first housing portion 100 includes a similarly shaped bracket 190 with a truncated top at its upper portion, which is formed at a first end of the first housing portion 100 and extends above the level of two lips 125, 135 extending laterally outward from the upper portion of a respective one of the two lateral side walls 120, 130.

[0095] Extending outwardly from what can be considered as the inwardly directed corners of the bracket 190 is a pair of spaced apart and downwardly directed snap-in locking pins 192, 195 with barbed heads. The angle at which the snap-in locking pins 192, 195 extend from the corners ensures that the snap-in locking pins 192, 195 are eccentrically positioned relative to the longitudinal axis of the first housing portion 100.

[0096] The two snap-on locking pins 192, 195 are spaced apart from each other by a distance that is complementary to the spacing associated with the two barrels 292, 295. In this regard, the two housing parts 100, 200 can be operatively coupled together by inserting the two snap-on locking pins 192, 195 of the first housing part 100 through the respective barrels 292, 295 of the second housing part 200 to form a pivotable arrangement at the respective first ends of the two housing parts 100, 200. In practice, when the barbed heads of the snap-on locking pins 192, 195 have passed through the respective barrels 292, 295, they expand to reduce the likelihood that the two housing parts 100, 200 will become easily separated.

[0097] Due to this hinge arrangement, the housing is configured to pivot between an open configuration and a closed configuration, in which the two housing parts 100, 200 are oriented at approximately 180 degrees relative to each other (eg, Figure 5 and Figure 6 As shown), in the closed configuration, the two housing parts 100, 200 are positioned side by side (as shown Figure 3 and Figure 4 Since the positions of the barrels 292, 295 and the corresponding snap-on locking pins 192, 195 are set, the housing is prevented from rotating to a position greater than 180 degrees.

[0098] Locking device

[0099] The cassette 10 also includes locking means to lock the two housing parts 100, 200 in position ready for insertion into a pair of adjacent channels 510 within the dyeing apparatus 500 when the housing is in a closed configuration.

[0100] In one embodiment, if Figure 1 , Figure 2 and Figure 5As shown, the locking means takes the form of a snap-fit ​​arrangement between a cantilevered hook 285 associated with portion 280 at the second end of second housing portion 200 and a complementary lip (not shown) located within a recess 330A within body portion 330 .

[0101] In use, when the corresponding second ends of the two shell parts 100, 200 are brought together, the protrusion of the cantilever hook 285 extending from the inward-facing surface of the small part 280 enters the recess 330A in the main body part 330, wherein the lip located inside is configured to engage the cantilever hook 285 via a snap-fit ​​arrangement to lock the two shell parts 100, 200 together when the shell is in a closed structure.

[0102] like Figure 7 and Figure 8 As shown, the corresponding orientation of the cylinders 292, 295 and the corresponding snap-on locking pins 192, 195 at the corresponding first ends of the two shell parts 100, 200, combined with the approximately 30-50% outwardly extending portion of the main body part 330 located at the second end of the first shell part 100 and the smaller portion 280 located at the second end of the second shell part 200, ensure that when the shell is in a closed structure, the two shell parts 100, 200 are sufficiently spaced apart from each other by a predetermined distance, which corresponds to the spacing between the pair of adjacent channels 510 located in the dyeing device 500, so that when the box 10 is loaded in the dyeing device 500, each shell part 100, 200 will be received in a corresponding one of the pair of adjacent channels 510.

[0103] To facilitate opening the housing from the closed configuration to the open configuration, the second housing portion 200 includes a tab 288 extending upwardly from an upper surface of a portion 280 formed at the second end of the second housing portion 200. In use, an operator can simply grasp the main body portion 320 of the handle 300 and gently pull the tab 280 to release the housing from the closed configuration.

[0104] The cassette 10 may include additional locking means to lock the two housing parts 100, 200 in place when the housing is in the open configuration.

[0105] In one embodiment, if Figure 2 , Figure 4 and Fig.12 As shown, the additional locking means takes the form of a snap-fit ​​arrangement in which the second housing portion 200 includes a cantilevered hook 296 extending from the outer surface of the bracket 290 at a location between the two barrels 292 , 295 .

[0106] At the same time the first housing portion 100 includes a complementary lip 196 extending from the outer surface of the bracket 190 at a location between the two downwardly angled snap-lock pins 192 , 195 , which is configured to engage the cantilevered hook 296 when the housing is in the open configuration.

[0107] The cantilever hook 296 is sufficiently flexible to enable an operator to release the cantilever hook 296 from the lip 196 by applying a gentle force to each of the two housing portions 100 , 200 in the direction required to place the housing in the closed configuration.

[0108] Brake pin

[0109] The box 10 is configured so that it can be locked or maintained in place within the staining device 500 when the housing is in a closed configuration.

[0110] In one embodiment, if Figure 2 , Figure 4 , Figure 7 , Fig. 9 and Fig.12 As shown, the first housing portion 100 includes a recess 197 that extends through a base portion of the bracket 190 at a first end of the first housing portion 100 .

[0111] The dyeing apparatus 500 includes a plurality of spring-loaded brake pins (not shown), each of which is slidably mounted within a corresponding substantially vertical channel (not shown) positioned directly beneath one of the plurality of channels 510 .

[0112] Thus, when the two housing portions 510 of the reagent cartridge 10 are received within a pair of adjacent channels 510 of the staining apparatus 500, a spring-biased detent pin slidably mounted within a vertical channel just below the channel 510 housing the first housing portion 100 is biased to move upwardly along the vertical channel until a generally pointed upper portion of the detent pin is substantially located within a recess 197 of a base portion of a bracket 190 extending through the first end of the first housing portion 100. This provides a means of retaining the reagent cartridge 10 in position within the staining apparatus 500.

[0113] Since the stop pin is spring biased, it is possible to remove the reagent cartridge 10 from the channel 510 of the staining apparatus 500 simply by pulling the handle 300 of the reagent cartridge 10. This action causes the base portion of the bracket 190 to act on the upper portion of the stop pin, causing the stop pin to be pushed downward along the generally vertical channel, thereby allowing the reagent cartridge 10 to be removed.

[0114] Electromagnetic lock

[0115] When the reagent cartridge 10 must be locked in place within the staining apparatus 500 , the locking mechanism to achieve this takes the form of an electromagnetic lock (not shown) located beneath the channel 510 of the staining apparatus 500 .

[0116] Activation of the electromagnetic lock can occur when one or more sensors (not shown) associated with one or both of a pair of adjacent channels 510 located within the staining device 500 determine that a corresponding one of the two shell parts 100, 200 of the shell (in a closed structure) located within the corresponding channel 510 when the box 10 is loaded into the staining device 500 is present.

[0117] Specifically, the electromagnetic lock is activated upon receiving a signal from one of the sensors when it is detected that the cartridge 10 has been loaded into the staining apparatus 500. This generates an electromagnetic field that causes a metal bolt (not shown) movably mounted relative to the body of the electromagnetic lock to transition from a retracted position, in which at least a portion of the metal bolt is partially located within the body of the electromagnetic lock, to an extended position, in which the metal bolt is repelled in a generally horizontal direction away from the body toward a spring-biased detent pin engaged in a recess 197 extending through a base portion of a bracket 190 located at a first end of the first housing portion 100. The metal bolt in the extended position is directly below the engaged spring-biased detent pin, which prevents the detent pin from being pushed downward by the base portion of the bracket 190, which acts on the upper portion of the spring-biased detent pin, when an operator applies a pulling force to the reagent cartridge 10, thereby locking the reagent cartridge 100 in place within the staining apparatus 500.

[0118] In addition to the electromagnetic lock, the flanges 110f, 110g and 210f, 210g extending outwardly from the respective base 110, 210 of each housing portion 100, 200 not only restrict lateral movement of the cartridge 10 within the staining apparatus 500, such lateral movement would prevent the software-controlled probe from being precisely positioned to engage each reagent container (e.g., see Fig.15 The flanges 110f, 110g and 210f, 210g also help limit the vertical movement of the box 10 located in the staining device 500 within the channel 510, which may occur when the brake pin is engaged in the recess 197.

[0119] To release the reagent cartridge 10 from the locked state, the operator need only disable the electromagnetic lock at the control panel (not shown) of the staining apparatus 500. This eliminates the electromagnetic field, causing the metal bolt to transition from the extended position back to the retracted position, thereby allowing the engaged spring-biased detent pin to move freely within the vertical channel.

[0120] In an alternative arrangement, the electromagnetic lock may simply be a latching solenoid, wherein power is momentarily applied to cause the metal bolt to transition from a retracted position to an extended position, and then when power is removed, the metal bolt remains in the extended position. To release the metal bolt, an opposite voltage is applied to the latching solenoid, which causes the metal bolt to transition back to a retracted position, where it is held until power is applied again.

[0121] As described above, when the box 10 is loaded into the staining device 500, each compartment Xa-Xj is located at a predetermined position within the channel 510 of the staining device 500, so that a probe (not shown) associated with the staining device 500 can be controlled by software to locate the opening of a specific reagent container received in one of the compartments Xa-Xj in a positionally accurate manner. Once the probe is in the correct position, the software program causes the probe to be lowered through the opening of the reagent container so that the reagent can be removed therefrom by suction.

[0122] advantage

[0123] The kit 10 according to the above-described preferred embodiment of the present invention provides a number of benefits.

[0124] For example, when the housing is in the closed configuration, the two housing portions 100, 200 are sufficiently spaced apart from one another to fit into a pair of adjacent channels 510 within the staining apparatus 500. This is beneficial because a conventional staining apparatus 500 configured to receive a plurality of individual cartridges does not need to be modified to accommodate the "foldable" reagent cartridge 10 of the present invention as desired for the better aspects.

[0125] Additionally, reagent containers manufactured for use with conventional staining apparatus 500 typically include a lid pivotally coupled to one of the side walls of the reagent container for covering the opening when the reagent container is not in use (e.g., see Fig.15 Before the reagent kit 10 can be loaded into the staining device 500, these covers must be opened to reveal the openings. However, since the reagent containers must be loaded into the compartments Xa-Xj of the two housing parts 100, 200 in a specific orientation so that they face the same direction when located in the channel 510 of the staining device 500, as in the case of using two separate reagent kits, it is possible to open the covers of the reagent containers when the housing is in the open configuration because the two housing parts 100, 200 are too close together to allow the covers of the reagent containers in the compartments Xf-Xj in the second housing part 200 to be opened when the housing is in the closed configuration.

[0126] Other Implementations

[0127] In other embodiments, the two parts 100, 200 of the housing may be made of metal, preferably medical grade metal, such as 316 stainless steel.

[0128] definition

[0129] Whenever a range is given in the specification, for example, a temperature range, a time range or a concentration range, all intermediate ranges and subranges and all individual values ​​included in the given range are intended to be included in the disclosure. It should be understood that any subrange or individual value in a range or subrange included in this specification may be excluded from the claims herein.

[0130] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0131] In this application, the term "about" is used to indicate that a value includes the inherent variation of error for the device, the inherent variation of error for the method being employed to determine the value, or the variation that exists between study subjects.

[0132] Unless explicitly indicated to the contrary, the indefinite articles "a" and "an" as used in this specification should be understood to mean "at least one".

[0133] The phrase "and / or" as used in the specification should be understood to mean "either or both" of the elements so combined, i.e., elements that are present in conjunction in some cases and separately in other cases. Multiple elements listed with "and / or" should be interpreted in the same manner, i.e., "one or more" of the elements so combined. In addition to the elements specifically identified by the "and / or" clause, other elements may optionally be present, whether related or unrelated to those specifically identified. Thus, as a non-limiting example, a reference to "A and / or B", when used in conjunction with open language such as "comprising", may refer to A only (optionally including elements other than B) in one embodiment; may refer to B only (optionally including elements other than A) in another embodiment; may refer to A and B (optionally including other elements) in yet another embodiment; and so on.

[0134] For ease of description, spatially relative terms such as "inside", "outside", "below", "below", "down", "above", "upper", etc. may be used herein to describe the relationship of one element or feature shown in the figures to another element or feature. Spatially relative terms may be intended to encompass different orientations of the device in use or operation in addition to the orientation shown in the figures.

[0135] Although the present invention has been described in conjunction with a limited number of embodiments, it will be appreciated by those skilled in the art that many substitutions, modifications and variations are possible according to the foregoing description. Therefore, the present invention is intended to include all such substitutions, modifications and variations that may fall within the spirit and scope of the disclosed invention.

[0136] Where the terms “comprises,” “includes,” “contains,” or “has” are used in this specification, they should be interpreted as specifying the presence of stated features, integers, steps, or components, but not excluding the presence of one or more other features, integers, steps, components, or groups thereof.

Claims

1. A box for arranging and loading reagent containers into a staining device, the box comprising: a housing having a base and walls upstanding from the base to define a plurality of compartments, each compartment being configured to receive a reagent container, wherein the housing comprises two housing portions pivotably coupled together at respective first ends thereof and configured to pivot between an open configuration in which the two housing portions are oriented at approximately 180 degrees relative to each other and a closed configuration in which the two housing portions are positioned side by side, wherein each housing portion of the housing in the closed configuration is receivable in a corresponding one of a pair of adjacent channels located in the staining device when the cartridge is loaded in the staining device, wherein, when the housing is in the closed configuration, the two housing parts are spaced apart from each other by a predetermined distance, the predetermined distance corresponding to the spacing between the pair of adjacent channels in the dyeing device, wherein each housing part comprises, at the location of each compartment, a hole extending substantially through its wall to at least partially receive a corresponding protrusion of a reagent container received in said compartment to ensure that said reagent container is correctly placed in said compartment, wherein the wall of each housing portion is a side wall, and wherein, when the housing is in the closed configuration, the aperture associated with only one of the two housing portions faces outwardly; and wherein a plurality of the holes extend through the side wall of each housing portion rather than through an opposing wall that is opposite to the side wall of each housing portion.

2. The box according to claim 1, wherein Each reagent container includes a lid pivotably coupled to a wall of the reagent container, and the box is configured such that the lids of those reagent containers received in the compartments associated with both housing parts can be opened only when the housing is in the open configuration.

3. The case of claim 1 further comprising a locking device to lock the two housing portions in place when the housing is in the closed configuration.

4. The box according to claim 3, wherein The locking device is located at a respective second end of each of the two housing parts.

5. The box according to claim 4, wherein The locking means takes the form of a snap-fit ​​arrangement, wherein the second end of one housing portion comprises a cantilevered hook and the second end of the other housing portion comprises a complementary recess configured to receive the cantilevered hook when the housings are in the closed configuration.

6. The cartridge according to claim 1, wherein The base extends outwardly from opposite lateral side walls of the shell to define a pair of flanges so that when the shell is in the closed configuration, the flanges of each shell portion can be slidably received by a corresponding pair of laterally opposed alignment guides, which are associated with each of the pair of adjacent channels located within the staining device when the box is substantially loaded within the staining device.

7. The cartridge according to claim 1, wherein At least one of the two shell parts includes a recess configured to receive a spring-biased brake pin, the movement of which is actuated by an electromagnetic lock associated with the dyeing device to substantially lock the box in an appropriate position within the dyeing device when the box is substantially loaded within the dyeing device.

8. The cartridge according to claim 7, wherein The recess is located at the first end of the at least one housing portion.

9. The cartridge according to claim 7, wherein: The recess extends through a portion of the base associated with the at least one housing portion.

10. The box according to claim 1 further includes a handle to facilitate loading and unloading of the box into and from the dyeing device.

11. The cartridge according to claim 10, wherein The handle is positioned at a second end of the housing portion having a recess at the first end.

12. The cartridge according to claim 10, wherein The handle includes a display panel for displaying identifiers associated with identities of the plurality of reagent containers loaded in the compartment.

13. The case of claim 1 further comprising a locking arrangement to lock the two housing portions in place when the housing is in the open configuration.

14. The cartridge according to claim 13, wherein The locking device is located at a respective first end of each of the two housing parts.

15. The cartridge according to claim 13, wherein The locking means takes the form of a snap-fit ​​arrangement, wherein the first end of one housing portion comprises a cantilevered hook and the first end of the other housing portion comprises a complementary lip configured to engage the cantilevered hook when the housings are in the open configuration.

16. The cartridge according to claim 1, wherein Each channel of a pair of adjacent channels within the staining device includes a sensor configured to determine the presence of a corresponding one of the two housing portions when the box is loaded into the staining device and the housing is in the closed configuration.

17. The cartridge of claim 1, wherein: When the box is loaded into the staining device, each compartment of the housing is positioned at a predetermined position within the staining device so that a probe associated with the staining device can be inserted in a precisely positioned manner through the opening of the reagent container received in each compartment to remove the reagent therefrom.

18. The cartridge of claim 1, wherein: The housing is made of an engineering polymer selected from the group consisting of acrylonitrile butadiene styrene (ABS), polypropylene (PP), high density polyethylene (HDPE), polycarbonate (PC), polyvinyl chloride (PVC) and polytetrafluoroethylene (PTFE).

19. The cartridge of claim 1, wherein: The housing is made of stainless steel.

20. The cartridge of claim 1, wherein: A wall defining each compartment of the plurality of compartments includes at least one rib to provide a friction fit with the reagent container when the reagent container is received in the compartment.

21. The cartridge of claim 1, wherein: The base includes a drainage hole located at the location of each of the plurality of compartments.

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