Patent Description:
Consumables can be used with sample processing instruments. These consumables include, for example, as receptacles, caps for closing receptacle openings, pipette tips, and containers storing reagents are used during processing of a sample. These consumable can also include, for example, components used to maintain sample processing instruments such as cleaning tools used to clean the ends of optical fibers. These consumables can be stored and packaged on a tray wrapped with shrink-wrap or lined with a peelable film to secure the consumables on the tray. Or these consumables can also be stored on tray having a rigid plastic cover, and the cover can be secured to the tray using a cardboard sleeve or box surrounding the cover and the tray.

The tray storing the consumables can be loaded into a sample processing instrument for use during sample processing. During this loading process, the shrink-wrap or peelable film is removed from the tray to provide instrument access to the consumables. Removing the shrink wrap or peelable film from the tray can require substantial user handling of the tray. For example, removing the shrink wrap or peelable film typically requires two hands, and the tray is often rotated and turned upside down. These handling requirements can increase the time it takes to load consumables into the sample processing instrument, increase the risk that the consumable will be spilled from the tray, and increase the risk of contamination of the consumables. Shrink-wrap and peelable films can also be cumbersome to tear and remove. Moreover, shrink-wrap and peelable films can generate undesirable static electricity.

Accordingly, there is a need for a sample processing consumable tray that can be efficiently and sterilely loaded into a sample processing instrument.

For further background, <CIT> describes a test tube rack for supporting, storing and carrying a plurality of test tubes in a laboratory environment comprising a tray, a central support panel and/or lower support panel and a cover. The tray and cover are identical and interchangeable, and tapered for storage in nested stacks. Wells in the tray bottom are in alignment with corresponding openings in the central support panel and corresponding holes in the lower support panel and with domes in the cover and serve to locate and retain test tubes within the test tube rack. The cover snapattaches to the tray by means of at least one molded-in tab on the tray or cover which is received and frictionally retained by a corresponding well on the opposite element, thereby locating and securing the cover to the tray, and also locating and securing the central support panel between the tray and the cover. A dual-purpose support panel has manually removable perforated edges allowing it to serve either as a central support panel or, with the perforated edges removed, as a lower support panel.

<CIT> describes a polymeric injection-molded container which holds capillaries for a biological material assay system in a vertical position. The container includes a two-piece base which is press-fit together. Ninety-six funnel-shaped holes in the top of the base receive the capillaries and support them circumferentially. Ninety-six apertures in the bottom of the base are tapered to guide the bottom ends of the capillaries to positions aligned with the holes in the top of the base. The inserted capillaries extend above the top surface of the base and are covered by a removable cover. The capillaries can be processed and placed in the container by the capillary manufacturer, shipped to a user in the container, and the container can be placed on the capillary holder station of an automated assay system and used by the automated system directly from the container.

<CIT> describes a filter strip and composite assemblies for filtering microliter quantities of fluids. A linear array of wells having open top and bottom ends are connected by frangible webs in spaced-apart relation with discrete filter membranes closing the bottom ends of each well. Tabs are provided on the ends of the filter strip for holding the same and supporting the strip in a rectangular holder having alpha-numeric designations for identifying each well in a plurality of such filter strips contained within the holder. The filter strip may be used in a vacuum manifold for applying a pressure differential across the filter membrane and directing the filtrate into an aligned aperture of a closed bottom well of an array of wells held within the manifold. Alternatively, the filter strip may be used with a transfer plate for directing the filtrate from each well of the filter strip to an aligned well of a closed bottom array of wells. Another composite assembly includes a pressure manifold for applying an increased pressure above the membranes.

<CIT> describes an evaporation control device for a multiwell plate system that reduces the evaporation from the plate such as during centrifugation. Preferably it substantially conforms to the shape and size of the plate system. A first design is a sheet material interposed between the adjacent surface of the plates. A second is a cover that has a skirt that extends downward from the top of the plate system to at least a point below the filter plate/collection plate interface. Preferably, the cover has a skirt that extends down to approximately the bottom of the collection plate and is formed of thin plastic that even more preferably has been vacuum formed into shape. A third embodiment is a combination of the two control devices.

In some embodiments, an assembly for storing sample processing consumables includes a cover defining a cover cavity. The assembly also includes a tray. The tray defines a first plurality of wells. The tray includes a first portion received within the cover cavity such that a press fit is formed between a first tray surface of the first portion of the tray and a first cover surface of the cover defining the cover cavity, thereby releasably coupling the cover to the tray. Each of the first plurality of wells contains a sample processing consumable.

The cover can be configured to be decoupled from the tray by applying a force to a panel of the cover to overcome the press fit. The panel can be adjacent a second tray surface of the tray defining openings of the first plurality of wells. The panel can be spaced apart from the second tray surface, or the panel can contact the second tray surface.

The cover can also include a cover wall extending from a perimeter of the panel, and the cover wall can include the first cover surface. The cover wall can define a hollow protrusion configured to prevent a vacuum from forming in the cover cavity when the first portion of the tray is received therein. The cover can be configured such that the cover wall remains stationary as the cover is decoupled from the tray by applying the force to the panel.

The cover can also include a flange extending outward from the cover wall. The flange can extend from a distal end of the cover wall. The panel, the cover wall, and the flange can be configured such that, when the tray is aligned with a support cavity defined by a support wall of a support, the flange contacts the support wall. The tray and the cover can be configured such that, when the flange contacts the support wall, the tray is spaced apart from a support base of the support further defining the support cavity.

The cover wall can have a cover dimension between the panel and the flange, and the tray can have a tray dimension between a bottom of the tray and the second tray surface. The tray dimension can be greater than the cover dimension such that a second portion of the tray extends beyond the flange in a direction away from the panel.

The support can be part of an instrument configured to perform an assay for determining the presence of an analyte in a sample. The support can be part of a drawer of the instrument. The support can be part of an instrument configured to perform sample preparation.

The first plurality of wells can contain a single type of sample processing consumable in some embodiments. The first plurality of wells contain at least a first type of sample processing consumable and a second type of sample processing consumable different than the first type of sample processing consumable in some embodiments. The sample processing consumable can be a receptacle, a cap for closing an opening of a receptacle, a pipette tip, a reagent container, or a cleaning member configured to clean or sterilize a component of a sample processing instrument.

The first plurality of wells can include a first subset of wells containing a first type of sample processing consumable, and a second subset of wells configured differently than the first subset of wells and containing a second type of sample processing consumable. The panel of the cover can define a plurality of protrusions configured to extend into portions of the second subset of wells.

The cover can be thermoformed. The assembly can be void of shrink-wrap. The tray can also define a second plurality of wells that do not contain sample processing consumables.

In some embodiments, a sample processing instrument is provided that includes a support. The support defines a support cavity receiving a tray. The tray stores a plurality of sample processing consumables for sample processing. A first portion of the tray is received within a cover cavity defined by a cover. A press fit is created between a first tray surface of the tray and a first cover surface of the cover defining the cover cavity, thereby releasably coupling the cover to the tray. The support, the tray, and the cover are configured such that, when a force is applied to a panel of the cover that overcomes the press fit, the tray is decoupled from the cover and seated in the support cavity.

The cover can also include a cover wall extending from a perimeter of the panel and a flange extending outward from the cover wall. The cover wall can include the first cover surface. The support can include a support base and a support wall extending from the support base. The support base and the support wall define the support cavity. The support, the tray, and the cover can be configured such, when the tray is aligned with the support cavity, the flange contacts the support wall.

The support, the tray, and the cover can be configured such that, when the flange contacts the support wall, the tray is spaced apart from the support base before any force is applied to the panel to overcome the press fit. The tray and the cover can be configured such that, when coupled together, a second portion of the tray extends beyond the flange and into the support cavity.

The tray can store a single type of sample processing consumable in some embodiments. The sample processing consumable can be a receptacle, a cap for closing an opening of a receptacle, a pipette tip, a reagent container, and a cleaning member configured to clean or sterilize a component of a sample processing instrument. The tray can store a first type of sample processing consumable and a second type of sample processing consumable different than the first type of sample processing consumable in some embodiments.

The sample processing instrument can be configured to perform an assay for determining the presence of an analyte in a sample. The sample processing instrument can be configured to perform sample preparation.

A method of loading consumables into a sample processing instrument is provided that includes aligning a tray with a support cavity defined by a support of the sample processing instrument. The tray stores sample processing consumables. The method also includes contacting a flange with a portion of the support. The flange extends outward from a wall of a cover coupled to the tray. The method also includes decoupling the cover from the tray by pressing a panel of the cover. The method also includes seating the tray in the support cavity.

The support can include a support base and a support wall extending from the base. The support base and the support wall can define the support cavity, and the support wall can include the portion of the support the flange contacts.

Aligning the tray with the support cavity can include inserting a portion of the tray extending beyond a cover cavity defined by the cover into the support cavity. Decoupling the cover from the tray and seating the tray in the cavity can occur simultaneously.

The method can also include removing, after decoupling the cover from the tray, the cover from the sample processing instrument.

The sample processing instrument can be configured to perform an assay for determining the presence of an analyte in a sample. The sample processing instrument is can be configured to perform sample preparation.

The sample processing consumables can be receptacles, caps for closing openings of the receptacles, pipette tips, reagent containers, and cleaning members configured to clean or sterilize a component of a sample processing instrument.

Seating the tray in the cavity can include dropping the tray into the support cavity.

Decoupling the cover from the tray by pressing the panel can include applying a force that overcomes a press fit formed between the cover and the tray.

In some embodiments, a method of loading consumables into a sample processing instrument includes aligning a tray with a cavity defined by a support of the sample processing instrument. The tray stores consumables and is coupled to a cover. The method also includes decoupling the cover from the tray by pressing a panel of the cover. The method also includes generating sensory feedback when the cover is decoupled from the tray, and seating the tray in the cavity defined by the support of the sample processing instrument.

The sensory feedback can include tactile feedback, audible feedback, and visual feedback. The tactile feedback can be generated by overcoming a press fit between the cover and the tray. The audible feedback can be generated by bending of the panel of the cover.

Decoupling the cover from the tray and generating sensory feedback can occur simultaneously. Decoupling the cover from the tray and seating the tray in the cavity can occur simultaneously.

Further features and advantages of the embodiments, as well as the structure and operational of various embodiments, are described in detail below with reference to the accompanying drawings. It is noted that the invention is not limited to the specific embodiments described herein. Such embodiments are presented herein for illustrative purposes only. Additional embodiments will be apparent to persons skilled in the relevant art(s) based on the teachings contained herein.

The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate the embodiments and, together with the description, further serve to explain the principles of the embodiments and to enable a person skilled in the relevant art(s) to make and use the embodiments.

The features and advantages of the embodiments will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, in which like reference characters identify corresponding elements throughout.

The present disclosure will now be described in detail with reference to embodiments thereof as illustrated in the accompanying drawings. References to "one embodiment," "an embodiment," "some embodiments," "an exemplary embodiment," "for example," "an example," "exemplary," etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic.

As used herein, "a" or "an" means "at least one" or "one or more.

As used herein, a "sample processing instrument" refers to any instrument capable of performing a processing step on a sample contained within a receptacle. A sample processing instrument includes any instrument capable of performing an assay on a sample and rendering a result. For example, a sample processing instrument includes any instrument capable performing an assay on a sample to determine the presence of an analyte in the sample. Any instrument capable of performing a hybridization assay, a molecular assay including a nucleic-acid-based amplification reaction, a sequencing assay, an immunoassay, or chemistry assay on a sample is included in this definition of a sample processing instrument. Exemplary sample processing instruments instrument capable performing an assay on a sample to determine the presence of an analyte in the sample include the Tigris® and Panther® systems sold by Hologic, Inc. , Bedford, MA, as well as any of the diagnostic instruments disclosed in <CIT>. A sample processing instrument also includes any instrument that only performs sample preparation steps and is not capable of analyzing a sample and/or rendering a result. For example, an instrument that transfers a sample from one receptacle to another receptacle or adds one substance to a receptacle containing a sample, but does not perform an assay on the sample, is a sample processing instrument. And, for example, an instrument that only performs sample preparation steps to isolate and/or purify an analyte of interest is a sample processing instrument. An exemplary sample processing instrument that only performs sample preparation steps is the Tomcat® system sold by Hologic, Inc. , Bedford, MA.

As used herein, a "sample" refers to any material to be analyzed, regardless of the source. The material may be in its native form or any stage of processing (e.g., the material may be chemically altered or it may be one or more components of a sample that have been separated and/or purified from one or more other components of the sample). A sample may be obtained from any source, including, but not limited to, an animal, environmental, food, industrial or water source. Animal samples include, but are not limited to, peripheral blood, plasma, serum, bone marrow, urine, bile, mucus, phlegm, saliva, cerebrospinal fluid, stool, biopsy tissue including lymph nodes, respiratory tissue or exudates, gastrointestinal tissue, cervical swab samples, semen or other body or cellular fluids, tissues, or secretions. Samples can be diluted or contained within a receptacle containing diluents, transport media, preservative solution, or other fluids. As such, the term "sample" is intended to encompass samples contained within a diluent, transport media, and/or preservative or other fluid intended to hold a sample.

As used herein, a "sample processing consumable" is any consumable intended to be used with a sample processing instrument. Exemplary sample processing consumables include, but are not limited to, receptacles, caps for closing openings of receptacles, pipette tips, and reagent containers. Exemplary sample processing consumables also include any consumable intended to be used to maintain the sample processing instrument. Exemplary maintenance sample processing consumables include, but are not limited to, members configured to clean and/or sterilize various components of the sample processing instrument, such as optical elements, test receptacle wells, and any other components of a sample processing instrument. For example, maintenance sample processing consumables include any of the cleaning members (such as cleaning members made of a material that generates static attraction, or cleaning members made of absorbent material capable of retaining a cleaning fluid or sterilizing substance) as disclosed in <CIT>.

As used herein, a "press fit" refers to a releasable coupling of two separate components by friction at an interface between surfaces of the components. A press fit does not include a snap fit in which separate components are coupled together by interlocking surfaces such as complementary flanges, ridges, or grooves.

In some embodiments, an assembly for storing sample processing consumables includes a tray that stores a plurality of sample processing consumables, and a cover that secures the consumables on the tray. The cover can also prevent contamination of the consumables. The cover can be releasably coupled to the tray by a press fit in some embodiments. The press fit can allow a user to easily and quickly decouple the cover from the tray when loading the tray into a sample processing instrument. For example, the cover can be decoupled from the tray using only one hand and with minimal handling of the assembly. Such a configuration can minimize the amount of user handling required to load the tray into a sample processing instrument.

<FIG> and <FIG> illustrate an assembly <NUM> according to an embodiment. Assembly <NUM> includes a cover <NUM> and a tray <NUM>. Cover <NUM> is releasably coupled to tray <NUM> by a press fit.

Tray <NUM> is configured to store a plurality of sample processing consumables. Exemplary types of sample processing consumables include, but are not limited to, receptacles, caps for closing openings of receptacles, pipette tips, and reagent containers. Tray <NUM> can be configured to store other types of sample processing consumables.

Tray <NUM> can define a plurality of wells <NUM> each configured to receive one or more sample processing consumables. In some embodiments, each well of the plurality of wells <NUM> is configured to receive only one sample processing consumable. In other embodiments, each well of the plurality of wells <NUM> is configured to receive more than one, for example, two or three, sample processing consumables.

In some embodiments, each of the plurality of wells <NUM> is configured (for example, shaped and sized) to contain a single type of sample processing consumable. For example, each of the plurality of wells <NUM> is configured to contain a receptacle, or each of the plurality of wells <NUM> is configured to contain a pipette tip.

In other embodiments, the plurality of wells <NUM> are configured to contain different types of sample processing consumables. For example, the plurality of wells <NUM> contains both receptacles and caps for closing the openings of the receptacles, or the plurality of wells <NUM> contain pipette tips and reagent containers. In such embodiments, the plurality of wells <NUM> can include two or more subsets of wells <NUM>, and each subset of wells <NUM> is configured (for example, shaped and sized) to contain a different type of sample processing consumable. For example, as shown in <FIG>, the plurality of wells <NUM> can include a first subset 106A of wells <NUM> configured to contain a first type of sample processing consumable, and a second subset 106B of wells <NUM> configured to contain a different type of sample processing consumable. In some embodiments, wells <NUM> of first subset 106A are shaped and sized differently than wells <NUM> of subset 106B. For example, as best seen in <FIG>, wells <NUM> of subset 106A are generally cylindrical, and wells <NUM> of subset 106B include an upper generally cylindrical portion and a lower conical portion. Wells <NUM> of subset 106A and subset 106B can have other suitable shapes.

In some embodiments as shown in <FIG>, wells <NUM> of first subset 106A can each be configured to contain a receptacle <NUM>, and wells <NUM> of second subset 106B can be can each be configured to contain a cap <NUM> that is configured to close the opening of receptacle <NUM>. In other embodiments, wells <NUM> of first and second subsets 106A and 106B are configured to contain types of sample processing consumables other than receptacles <NUM> and caps <NUM>, for example, pipette tips, and reagent containers.

In some embodiments, wells <NUM> are sized such that the entire consumable (for example, receptacle <NUM> or cap <NUM>) fits within a respective well <NUM>, as shown in <FIG>. In such embodiments, consumables <NUM> and <NUM> do not extend above a top surface of tray <NUM> (for example, a surface <NUM> described further below), and do not extend below a bottom surface of tray <NUM> (for example, a surface <NUM> described further below).

In some embodiments, receptacles <NUM> are configured to receive and store fluid samples for subsequent analysis, including analysis with nucleic acid-based assays or immunoassays diagnostic for a particular analyte. Receptacle <NUM> can be a single-piece receptacle that includes a generally cylindrical upper portion and a tapered lower portion. The upper portion has an opening through which fluid samples can be deposited or removed from receptacle <NUM>. The tapered lower closed portion can be either flat or rounded to provide optical communication with an optical system, for example, one or more optical fibers (not shown) of a biochemical analyzer such as those disclosed in <CIT>. Exemplary receptacles <NUM> include any of the receptacles disclosed in <CIT>. In some embodiments, caps <NUM> include a lower portion having an outer surface for sealing engagement of an inner surface of the upper portion of receptacle <NUM>, and caps <NUM> can include an upper portion. The upper portion of cap <NUM> can include an opening for frictional attachment to a portion of a receptacle transport mechanism, such as a tubular probe of a pipettor or a pick-and-place robotic arm. Exemplary caps <NUM> include any of the caps disclosed in <CIT>.

Tray <NUM> can include a surface <NUM> defining the openings of the plurality of wells <NUM>. Surface <NUM> is positioned at the top of tray <NUM> in some embodiments as shown in <FIG>. In some embodiments, surface <NUM> is substantially rectangular when viewed from above as shown in <FIG>. The substantially rectangular shape of surface <NUM>, when viewed from above, can have tapered corners <NUM> (which can correspond to tapered corners <NUM> of a cavity <NUM> defined by a support <NUM> as shown, for example, in <FIG>) in some embodiments. In some embodiments, the asymmetric shape of tray <NUM> about the minor axis of tray <NUM> (and corresponding asymmetric shape of cavity <NUM>) formed by tapered corners <NUM> ensures that tray <NUM> is properly oriented within the cavity defined by the support, which as described further below. Tray <NUM> can be a substantially rectangular prism, as shown in <FIG>, in some embodiments. In other embodiments, tray <NUM> can have other suitable shapes, such as circular, square, or any other suitable shape.

In some embodiments, tray <NUM> includes a surface <NUM> extending from surface <NUM>. Surface <NUM> can extend from the perimeter of surface <NUM> in a downward direction. Surface <NUM> can overlap wells <NUM> in a vertical direction in some embodiments as shown in <FIG>. In some embodiments, surface <NUM> surrounds the entire perimeter of surface <NUM> as shown in <FIG>. In other embodiments, surface <NUM> surrounds only a portion of the perimeter of surface <NUM>. Surface <NUM> can be plane in the substantially vertical direction as shown in <FIG>. In some embodiments, surface <NUM> is perpendicular to surface <NUM>. In other embodiments, surface <NUM> forms an oblique or acute angle with surface <NUM>.

Tray <NUM> can be made of any suitable plastic material in some embodiments. In other embodiments, tray <NUM> can be made of any suitable metal material, for example, stainless steel.

Turning to cover <NUM>, cover <NUM> defines a cavity <NUM> configured to receive at least a portion <NUM> of tray <NUM>, as best seen in <FIG>. Portion <NUM> of tray <NUM> can be an upper portion of tray <NUM>, as shown in <FIG>, in some embodiments. Cavity <NUM> is shaped and sized such that, when portion <NUM> is received within cavity <NUM>, a press fit is formed between cover <NUM> and tray <NUM>, thereby releasably coupling cover <NUM> to tray <NUM>. For example, tray <NUM> and cover <NUM> can include surfaces that engage one another to form the press fit when portion <NUM> of tray <NUM> is received within cavity <NUM>. As shown in <FIG>, wall <NUM> includes an inner surface <NUM>, and a press fit can be formed at the interface between inner surface <NUM> of wall <NUM> and surface <NUM> of tray <NUM> when portion <NUM> of tray <NUM> is received within cavity <NUM>. In such embodiments, cover <NUM> and tray <NUM> are coupled by a press fit, not a snap fit. In some embodiments, the interface forming the press fit, for example, between (a) surface <NUM> of wall <NUM> and (b) surface <NUM> of tray <NUM>, extends around substantially the entire perimeter of cover <NUM> and tray <NUM>. In other embodiments, the interface forming the press fit extends around only a portion or portions of the perimeter of cover <NUM> and tray <NUM>.

In some embodiments, cover <NUM> includes a panel <NUM> and a wall <NUM> extending therefrom. Panel <NUM> and wall <NUM> collectively define cavity <NUM> of cover <NUM>. Cavity <NUM> can have a shape and size that closely corresponds to the shape and size of tray <NUM>. For example, tray <NUM> is a substantially rectangular prism, as shown in <FIG>, and cavity <NUM> is a substantially rectangular prism, as show in <FIG>, in some embodiments.

Wall <NUM> extends downward from the perimeter of panel <NUM>. In some embodiments, wall <NUM> surrounds the entire perimeter of panel <NUM>, as shown in <FIG>. In other embodiments, wall <NUM> surrounds only a portion of the perimeter of panel <NUM>.

Panel <NUM> of cover <NUM> can form the top of cover <NUM> in some embodiments, as shown in <FIG>. In other embodiments, panel <NUM> can be positioned at an intermediate position of cover <NUM>. In some embodiments, panel <NUM> can be substantially rectangular when viewed from above, as shown in <FIG>. The substantially rectangular shape of panel <NUM>, when viewed from above, can have tapered corners <NUM> (which can correspond to tapered corners <NUM> of tray <NUM>) in some embodiments.

Cover <NUM> can be configured to be decoupled from tray <NUM> by applying a force to a location on panel <NUM> of cover <NUM> that overcomes the press fit between cover <NUM> and tray <NUM>. In some embodiments, the location where the force is applied is at a center of panel <NUM>. Panel <NUM> can include indicia <NUM> that indicate to a user where to apply the force. Indicia <NUM> can be text (e.g., "PUSH HERE TO REMOVE COVER," as shown in <FIG>) or symbols (e.g., a graphical representation of one or more fingers pushing on a surface). When a user applies a force to panel <NUM>, panel <NUM> flexes, which transfers the applied force to tray <NUM> and causes tray <NUM> to move relative to cover <NUM> as described in more detail below. In some embodiments, an audible noise is generated when panel <NUM> flexes.

In some embodiments, the magnitude of the force required to overcome the press fit between cover <NUM> and tray <NUM> is greater than the weight of tray <NUM>. In such embodiments, tray <NUM> will not fall out of cavity <NUM> of cover <NUM> on its own-due to the force of gravity acting on tray <NUM>. In some embodiments, the magnitude of the force required to overcome the press fit between cover <NUM> and tray <NUM> is such that a user can easily decouple tray <NUM> from cover <NUM>, for example, by the push of a finger or two on panel <NUM> of cover <NUM>. In some embodiments, the magnitude of force required to overcome the press fit between cover <NUM> and tray <NUM> can be in the range from about <NUM> N to about <NUM> N. For example, the required force magnitude can be in the range from about <NUM> N to about <NUM> N. In some embodiments, the required force magnitude can be at least <NUM> N.

Cover <NUM> can be configured such that wall <NUM> remains substantially stationary as cover <NUM> is decoupled from tray <NUM> by applying a force to panel <NUM> in some embodiments. That is, when a force is applied to panel <NUM> to overcome the press fit, wall <NUM> do not substantially deflect outward or inward relative to panel <NUM>. The orientation of wall <NUM> relative to panel <NUM> stays substantially the same. Accordingly, cover <NUM> can be decoupled from tray <NUM> without wall <NUM> substantially deflecting relative to panel <NUM>.

In other embodiments, cover <NUM> can be configured such that wall <NUM> bows slightly inward or outward as cover <NUM> is decoupled from tray <NUM>.

Referring to <FIG>, when cover <NUM> is releasably coupled to tray <NUM>, panel <NUM> is adjacent surface <NUM> of tray <NUM> defining the openings of the plurality of wells <NUM> such that consumables <NUM> and <NUM> contained within wells <NUM> cannot fall out of wells <NUM>, even when tray <NUM> is inverted, such that the openings of wells <NUM> face downward. In some embodiments, panel <NUM> is adjacent surface <NUM> of tray <NUM>, such that panel <NUM> is spaced apart from surface <NUM> of tray <NUM>. In other embodiments, panel <NUM> is adjacent surface <NUM> of tray <NUM> such that panel <NUM> contacts surface <NUM> of tray <NUM>. In some embodiments, panel <NUM> can also include a plurality of protrusions <NUM> configured to extend into at least some of the plurality of wells <NUM> when cover <NUM> is coupled to tray <NUM>. For example as best seen in <FIG>, panel <NUM> can include a plurality of protrusions <NUM> configured to extend into each well <NUM> of second subset 106B that contains a consumable, for example, a receptacle <NUM>. Each protrusion <NUM> can have a trough <NUM> configured to be adjacent (e.g., contacting or near but spaced apart from) a respective top portion of consumable <NUM>. Trough <NUM> being adjacent the consumable <NUM> in well <NUM> substantially prevents movement of consumable <NUM> within well <NUM>.

Wall <NUM> can define one or more hollow protrusions <NUM>. Hollow protrusions <NUM> are configured to prevent a vacuum from forming in cavity <NUM> of cover <NUM> when portion <NUM> of tray <NUM> is received within cavity <NUM>. Preventing a vacuum from forming in cavity <NUM> helps ensure that cover <NUM> can be easily decoupled from tray <NUM> by pressing panel <NUM>.

Cover <NUM> includes a flange <NUM> extending outward from wall <NUM> in some embodiments. As shown in <FIG>, flange <NUM> extends from a distal end of wall <NUM>. In other embodiments, flange <NUM> extends from an intermediate portion of wall <NUM>. In some embodiments, flange <NUM> surrounds around the entire perimeter of wall <NUM> as shown in <FIG>. In other embodiments, flange <NUM> surrounds only a portion of the perimeter of wall <NUM>. As shown in <FIG>, the cover can have a dimension <NUM> between panel <NUM> and flange <NUM>. In some embodiments, dimension <NUM> is about <NUM> to about <NUM>. For example, dimension <NUM> can be about <NUM>. In some embodiments, dimension <NUM> is large enough such that a user can place substantially the entire user's thumb and finger tips on wall <NUM> while handling assembly <NUM>.

In some embodiments, a portion of tray <NUM> is configured to be received within a cavity defined by a support <NUM>. <FIG> illustrates support <NUM> according to an embodiment. In some embodiments, support <NUM> is part of a sample processing instrument. That is, the sample processing instrument can store sample processing consumables, for example, within the housing of the processing instrument, using support <NUM>. For example, support <NUM> may be part of an instrument configured to perform an assay for determining the presence of an analyte in a sample. For example, support <NUM> may be part of the Tigris® and Panther® systems sold by Hologic, Inc. , Bedford, MA, and for example, support <NUM> may be part of any of the diagnostic instruments disclosed in <CIT>. In some embodiments, support is part of an instrument configured to perform only sample preparation on samples contained in receptacles, and not to perform an assay for determining the presence of an analyte in a sample. For example, support <NUM> may be part of an instrument similar to the Tomcat® system sold by Hologic, Inc. , Bedford, MA.

In some embodiments, support <NUM> is part of a drawer or sliding surface of a sample processing instrument. In such embodiments, support <NUM> moves along with the drawer or sliding surface.

Support <NUM> defines a cavity <NUM> configured to receive at least a portion (e.g., the lower portion) of tray <NUM>. Support <NUM> includes a base <NUM> and a wall <NUM> extending upward from the perimeter of base <NUM>. Base <NUM> and wall <NUM> collectively define cavity <NUM> of support <NUM>. In some embodiments, wall <NUM> surrounds the entire perimeter of base <NUM> as shown in <FIG>. In other embodiments, wall <NUM> surrounds only a portion of the perimeter of base <NUM>. In some embodiments, base <NUM> is substantially planar in the horizontal direction as shown in <FIG>. In some embodiments, wall <NUM> is substantially planar in the vertical direction as shown in <FIG>.

In some embodiments, base <NUM> has a substantially rectangular shape, when viewed from above, as shown in <FIG>. And, as shown in <FIG>, support <NUM> can have tapered corners <NUM> (which can correspond to tapered corners <NUM> of tray <NUM>, as shown in <FIG>) in some embodiments. In some embodiments, the asymmetric shape of support <NUM> and cavity <NUM> about the minor axis of support <NUM> (and corresponding asymmetric shape of tray <NUM>) formed by tapered corners <NUM> ensures that tray <NUM> is properly oriented within cavity <NUM> defined by support <NUM>.

Panel <NUM>, wall <NUM>, and flange <NUM> can be configured such that, when tray <NUM> is aligned with cavity <NUM> defined by support <NUM>, a portion <NUM> of tray <NUM> is inserted within cavity <NUM>, flange <NUM> contacts wall <NUM> of support <NUM>, as shown in <FIG>. When flange <NUM> contacts wall <NUM> of support <NUM>, a bottom surface <NUM> of tray <NUM> is spaced apart from base <NUM> of support <NUM> by a gap <NUM>. In some embodiments, gap <NUM> is about <NUM> to about <NUM>, for example, about <NUM>. Gap <NUM> provides clearance for tray <NUM> to move downward towards base <NUM> of support <NUM> as panel <NUM> deflects downward from a user pressing against panel <NUM>, causing panel <NUM> to press against surface <NUM> of tray <NUM>.

Tray <NUM> has a dimension <NUM> between a bottom surface <NUM> of tray <NUM> and surface <NUM> defining the openings of wells <NUM> of tray <NUM>. In some embodiments, dimension <NUM> is greater than dimension <NUM> between flange <NUM> and panel <NUM> of cover <NUM> such that portion <NUM> of tray <NUM> extends beyond flange <NUM> in a direction away panel <NUM> and toward base <NUM> of support <NUM>. Portion <NUM> of tray <NUM> can be used to register the proper alignment between cavity <NUM> of support <NUM> and tray <NUM> before tray <NUM> is decoupled from cover <NUM>.

In some embodiments, cavity <NUM> of support <NUM> can be omitted. In such embodiments, cover <NUM> and tray <NUM> can be positioned above a surface of support <NUM>, and then a force can be applied to panel <NUM> of cover <NUM> that overcomes the press fit between cover <NUM> and tray <NUM>, decoupling tray <NUM> from cover <NUM>. Tray <NUM> then drops onto the surface of support <NUM>.

In some embodiments, assembly <NUM> is devoid of shrink-wrap and peelable film. In some embodiments, assembly <NUM> is devoid of a cardboard sleeve or box surrounding cover <NUM> and tray <NUM>.

Cover <NUM> can be made of any suitable plastic. In some embodiments, cover <NUM> is made of any suitable plastic that can be thermoformed. In some thermoformed embodiments, cover <NUM> is made of polyethylene terephthalate glycol (PETG), amorphous or crystallized polyethylene terephthalate (PET), polyvinyl chloride (PVC), or polystyrene (PS). In some embodiments, cover <NUM> is made of an FDA compliant plastic.

In some embodiments, cover <NUM> includes an electrostatic dissipative (ESD) coating on at least the surfaces facing tray <NUM>-the surfaces defining cavity <NUM>. These surfaces include, for example, surface <NUM> of wall <NUM> and the cover surface adjacent to surface <NUM> of tray <NUM>. The ESD coating can reduce the amount of static build up generated, for example, by the consumables moving within wells <NUM> of tray <NUM>. Static build up can potentially cause cover <NUM> to stick to tray <NUM>, preventing or making difficult the decoupling of cover <NUM> from tray <NUM>.

In some embodiments, cover <NUM> has a thickness that provides sufficient rigidity to maintain engagement with tray <NUM>, but the thickness is not too great, such that cover <NUM> is stiff and difficult to decouple from tray <NUM>. For example, cover <NUM> can have a thickness in the range from about <NUM> mil to about <NUM> mil, such as <NUM> mil. In some embodiments, cover <NUM> has a thickness that allows cover <NUM> to be thermoformed without any voids in cover <NUM> being formed as the draws of cover <NUM> are formed.

In some embodiments, cover <NUM> is thermoformed. For example, cover <NUM> is made by heating a plastic sheet to a temperature at which the sheet is pliable and then forming the plastic sheet into the desired shape of cover <NUM> using a mold.

Tray <NUM> can be made of any suitable plastic. For example, tray <NUM> can be made of polypropylene (PP), polyethylene (PE), polystyrene (PS), polyester, or any other suitable plastic.

In some embodiments (not shown), cover <NUM> includes an RFID label to identify the consumable(s) contained in the wells <NUM> of tray <NUM>.

Turning to methods of using assembly <NUM>, assembly <NUM> can be used to load consumables into a sample processing instrument. In some embodiments, a loading method includes roughly aligning tray <NUM> with a desired location on support <NUM>, for example, cavity <NUM> of support <NUM> or any desired surface of support <NUM>. A user can hold assembly <NUM> by cover <NUM> using one hand, and then move assembly <NUM> such that portion <NUM> of tray <NUM> is roughly aligned with the desired location, for example, cavity <NUM> as shown in <FIG>.

Next, the user can move assembly <NUM> in a direction <NUM> toward support <NUM>. Portion <NUM> of tray <NUM> is inserted into cavity <NUM> of support <NUM>, registering the proper alignment between tray <NUM> and cavity <NUM> until flange <NUM> contacts an upper surface of wall <NUM> of support <NUM>, as shown in <FIG>. And at this point, the bottom surface <NUM> of tray <NUM> is spaced apart from base <NUM> of support <NUM>, as shown in <FIG>. This step can also be accomplished by holding cover <NUM> with hand. In some embodiments in which support <NUM> does not include cavity <NUM> (not shown), the user can move assembly <NUM> in a direction <NUM> toward support <NUM>, but leaving a space between bottom surface <NUM> of tray <NUM> and the desired surface location of support <NUM>.

Next, a user can press down on panel <NUM> of cover <NUM> to apply a force <NUM> that overcomes the press fit formed between cover <NUM> and tray <NUM>. In some embodiments, the user's finger(s), for example, the index finger and/or middle finger, can be used to apply force <NUM> to panel <NUM>. As shown in <FIG>, the user can press down on panel <NUM> such that force <NUM> is located at the substantially center of panel <NUM>. As the user presses down on panel <NUM>, panel <NUM> deflects downward pushing against surface <NUM> of tray <NUM>. Because flange <NUM> is abutted against wall <NUM> of support <NUM>, cover <NUM> does not move (other than deflection of panel <NUM>) relative to support <NUM>. Thus, applying force <NUM> overcomes the press fit between cover <NUM> and tray <NUM> and moves tray <NUM> relative to cover <NUM>. In some embodiments, the magnitude of force <NUM> is in the range from about <NUM> N to about <NUM> N. Tray <NUM> then drops into cavity <NUM> of support <NUM> such that bottom surface <NUM> of tray <NUM> rests against base <NUM> of support <NUM>. <FIG> illustrates tray <NUM> seated in cavity <NUM> of support <NUM> after tray <NUM> is decoupled from cover <NUM>. In some embodiments, cover <NUM> is decoupled from tray <NUM> simultaneously with tray <NUM> being seated within cavity <NUM> of support <NUM>.

Sensory feedback to the user can be generated when cover <NUM> is decoupled from tray <NUM>. Exemplary sensory feedback includes tactile, audible, and visual feedback. In some embodiments, tactile feedback is generated by overcoming the press fit between cover <NUM> and tray <NUM>. As the user presses down on panel <NUM> of cover <NUM>, the user can feel the press fit between cover <NUM> and tray <NUM> being overcome, and can feel tray <NUM> seating with cavity <NUM> of support <NUM>. In some embodiments, audible feedback is generated as panel <NUM> bends from the user pressing against panel <NUM>. As panel <NUM> bends, panel <NUM> generates an audible noise that the user can hear. And in some embodiments, visual feedback is generated as cover <NUM> and tray <NUM> are decoupled. For example, cover <NUM> can be transparent such that the user can see the position of tray <NUM> relative to cover <NUM>. As the user presses down on panel <NUM> of cover <NUM>, the user can see the position of tray <NUM> relative to cover <NUM>. Consequently, the user can see when tray <NUM> is decoupled from cover <NUM> and seated within cavity <NUM> of support <NUM>.

In some embodiments as the user presses down on panel <NUM>, walls <NUM> remain substantially stationary-walls <NUM> do not deflect relative to panel <NUM> (inward or outward).

After tray <NUM> is seated within cavity <NUM> of support <NUM>, the user can move cover <NUM> in direction <NUM> to remove cover <NUM> from tray <NUM> and from the sample processing instrument. At this point, the sample processing instrument has access to the consumables contained within wells <NUM> of tray <NUM>. In some embodiments, the sample processing instrument can then perform an assay for determining the presence of an analyte in a sample using the consumables contained within wells <NUM>. In some embodiments, the sample processing instrument can then perform sample preparation steps using consumables contained within wells <NUM>.

Notably, in some embodiments, the user can load tray <NUM> onto support <NUM> using just one hand and gripping only cover <NUM> (i.e., no direct contact between the user's hand and tray <NUM>). In such embodiments, the user never has to touch tray <NUM> for loading tray onto support <NUM> or for decoupling cover <NUM> from tray <NUM>. This can make loading consumables into the sample processing instrument easy and reduces the risk of contamination to the consumables contained within wells <NUM>. This also reduces the amount of user handling required.

Although the above embodiments are described using cover <NUM> and tray <NUM> to store sample processing consumables, cover <NUM> and tray <NUM> can be used to store consumables or other removable items that are not sample processing consumables. For example, cover <NUM> and tray <NUM> can be used with other consumables or other removable items that are not intended to be used with sample processing instruments or that are intended to be used in outside of the laboratory or clinical environments.

While the present disclosure has been described and shown in considerable detail with reference to certain illustrative embodiments, including various combinations and sub-combinations of features, those skilled in the art will readily appreciate other embodiments and variations and modifications thereof as encompassed within the scope of the present disclosure. Moreover, the descriptions of such embodiments, combinations, and sub-combinations are not intended to convey that the disclosure requires features or combinations of features other than those expressly recited in the claims. The present invention is nevertheless defined by the appended claims.

Embodiments have been described above with the aid of functional building blocks illustrating the implementation of specified functions and relationships thereof.

The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying knowledge within the skill of the art, readily modify and/or adapt for various applications such specific embodiments, without undue experimentation, and without departing from the general concept of the present invention. Therefore, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance of the claims.

It is to be understood that the phraseology or terminology herein is for the purpose of description and not of limitation, such that the terminology or phraseology of the present specification is to be interpreted by the skilled artisan in light of the teachings and guidance.

The breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

Claim 1:
An assembly for storing sample processing consumables, comprising:
a cover (<NUM>) defining a cover cavity (<NUM>) and comprising a panel (<NUM>) and a cover wall (<NUM>) extending from a perimeter of the panel (<NUM>), the cover wall (<NUM>) comprising a first cover surface; and
a tray (<NUM>) defining a first plurality of wells (<NUM>) and comprising a first portion received within the cover cavity (<NUM>) such that a press fit is formed between a first tray surface of the first portion of the tray and the first cover surface of the cover defining the cover cavity (<NUM>), thereby releasably coupling the cover (<NUM>) to the tray (<NUM>),
wherein each of the first plurality of wells (<NUM>) contains a sample processing consumable;
wherein the cover (<NUM>) is configured to be decoupled from the tray (<NUM>) by applying a force against the panel of the cover (<NUM>),
wherein the panel (<NUM>) is configured to flex, to transfer the applied force to the tray (<NUM>), and to cause the tray (<NUM>) to move relative to the cover to overcome the press fit, the panel (<NUM>) being adjacent to a second tray surface of the tray defining openings of the first plurality of wells (<NUM>).