Patent Description:
Exemplary systems, apparatuses and methods for performing automated biochemical assays employing optical fibers to transmit electromagnetic radiation reflected and/or emitted by samples contained in test receptacles, are disclosed and described, by way of non-limiting examples, in each of <CIT>, entitled "Indexing Signal Detection Module"; <CIT>, entitled "Diagnostic Systems and Methods"; <CIT>, entitled "Interlocking Cap and Receptacle for Automated Processes"; <CIT>, entitled "System, Method and Apparatus for Automated Incubation"; and<CIT>.

As disclosed and described in <CIT>, a "thermocycler" of an exemplary system used for performing automated fiber optic interrogation (testing) of a sample, such as a biological sample, includes a plurality of test receptacle holders (e.g., <NUM>), each holder having a plurality of (e.g., <NUM>) test receptacle wells. Each test receptacle well has an open bottom end, and is configured to have a test receptacle seated therein in a stable manner. By this arrangement, optical interrogation of a sample contained in a test receptacle seated in the test receptacle well may be performed using light transmitted and/or received through an axial-facing distal end of an optical fiber positioned proximate the open bottom of the respective test receptacle well.

<CIT> discloses the preamble of claims <NUM> and <NUM>.

For the test results to be reliable, it is critical that the optical pathway extending between, and including, the end surfaces of the respective optical fiber and test receptacle be free and clear of any debris, such as dust, fibers, hair and/or other particulate materials, that may interfere with the optical interrogation process. Debris can be especially problematic when the test receptacle holders are open to the atmosphere (i.e., without any cover or lid) in order to allow for easy insertion and extraction of the test receptacles into and out of the test receptacle wells. Debris may exhibit autofluorescence, i.e., in which the debris material naturally fluoresces, or may be non-fluorescent. While debris that fluoresces is generally easy to detect, debris that does not fluoresce can be difficult to detect. As a result, non-fluorescing debris can interfere with the passage of light without being detected and, consequently, lead to false or misleading test results.

As such, upon detection of any debris on or over the end of an optical fiber that may be interfering with a light signal path, the respective test receptacle well(s) and optical fiber end are not able to be used to perform further testing of sample test receptacles until they are manually cleaned, e.g., using a cotton swab or compressed air (similar to cleaning a keyboard). Furthermore, because some types of interfering debris are not readily detectable, the axial-facing ends of the optical fibers must be periodically cleaned, generally during routine servicing by a field service technician, to ensure that non-detected debris does not have an adverse effect on the sample testing. The frequency of regular cleaning can be expensive both in terms of the cleaning expense, and in terms of the lost time for testing while the system is shut-down for cleaning. Moreover, in the event immediate manual cleaning of detected debris is not performed, the respective optical fiber and/or test receptacle well are no longer available for reliable testing in the meantime, and their use must be disabled, thereby reducing the throughput of the system.

Other components of the sample testing systems may also require periodic manual cleaning and/or sterilization. For example, test receptacle wells may be exposed to sample material or reagents on the outer surfaces of receptacles, flakes of plastic, hair and/or environmental particles or contaminates, and may also require periodic manual cleaning and/or sterilization to avoid cross-contamination between samples or other problems that may arise as a result of such exposure.

In accordance with the present invention, there is defined a sample testing apparatus according to claim <NUM>.

The cleaning member includes a proximal coupling element joined to a distal cleaning element, where the coupling element has a proximal end portion configured to releasably mate with a distal working end portion of the automated transport arm. The coupling element and the cleaning element may be separately molded components, in which a distal portion of the coupling element forms, by way of non-limiting examples, an interference fit or a frictional fit with a proximal portion of the cleaning element in order to subsequently join the elements together. Alternatively, the coupling element and the cleaning element may be co-molded as a single component. The automated transport arm is preferably configured to move the detachably-coupled cleaning member into a position such that the cleaning element is inserted into a test receptacle well of the test receptacle support structure, and where the cleaning element is dimensioned such that an outer surface of the cleaning element conforms to an interior surface of the test receptacle well. By way of non-limiting example, the outer surface of the cleaning element and the interior surface of the test receptacle well may have complementary, frustoconical shapes. The cleaning element preferably cleans, decontaminates and/or sterilizes the interior surface of the test receptacle well when inserted therein. In one embodiment, the test receptacle well has an open bottom, and the optical element is an optical fiber having an end positioned proximate to the open bottom of the test receptacle well, where the cleaning element cleans, decontaminates and/or sterilizes the end of the optical fiber when inserted into the test receptacle well.

In exemplary embodiments, the cleaning element may be made out of an adhesive material, such as (without limitation) silicone, platinum cured silicone, thermoplastic polyurethane, thermoplastic elastomer, thermoplastic rubber, or a gel. Additionally or alternatively, the cleaning element may be made out of a material that generates a static attraction to particulates and/or other materials that can interfere with the transmission by the optical element of electromagnetic radiation emitted or reflected by the sample, such as (without limitation) silicon, polyvinyl chloride, polypropylene, polyethylene, polyurethane, polyester or polystyrene. In other embodiments, the cleaning element may be made out of an absorbent material capable of retaining and applying a fluid substance, such as (without limitation) isopropyl alcohol, ethyl alcohol, diluted hydrochloric acid, oxalic acid, diluted sodium hydroxide and diluted sodium hypochlorite.

The automated transport arm is preferably configured to selectively deposit the decoupled cleaning member into the same or a different cleaning member well from which the decoupled cleaning member was removed. Alternatively and/or additionally, the automated transport arm is configured to selectively deposit the decoupled cleaning member into a waste output. The system preferably includes a controller that controls operation of the automated transport arm for causing the automated transport arm to detachably couple with a cleaning member located in a respective cleaning member well, and to move the detachably-coupled cleaning member into a position proximate to and/or contacting the one or more optical fiber ends based upon one or both of a (i) predetermined cleaning schedule, and (ii) sensed presence of particulates and/or other materials disposed on or over the optical fiber ends. Depending on the relative position of the optical fiber, the distal portion of the cleaning member of this embodiment may be dimensioned to extend to and/or through the open bottom end of the respective test receptacle well in order for the distal tip of the cleaning member to be located proximate to or in contact with the end of the respective optical fiber. The cleaning element is preferably dimensioned such that an outer surface of the cleaning element conforms to an interior surface of the test receptacle well, such that the cleaning element cleans, decontaminates and/or sterilizes one or both of (i) the interior surface of the test receptacle well, and (ii) the end of the respective optical fiber, when the cleaning element is inserted into the test receptacle well.

In accordance with the present invention, there is also defined a method according to claim <NUM>.

In an exemplary method, the cleaning member has a proximal coupling element and a distal cleaning element, where the automated arm detachably couples the cleaning member to the working end portion of the transport arm by detachably coupling a proximal end portion of the coupling element to the working end of the transport arm, and inserting a distal end connector of the coupling element into a recessed proximal portion of the cleaning element to thereby attach (e.g., by an interference or frictional fit) the cleaning element to the coupling element. In some such embodiments, the system includes a cleaning element holder having a plurality of cleaning element receptacles, the cleaning element being one of a plurality of cleaning elements held in respective cleaning element receptacles of the cleaning element holder. In particular, the automated transport arm inserts the distal end connector of the coupling element into the recessed proximal portion of the cleaning element while the cleaning element is held in the respective cleaning element receptacle. In such embodiments, the cleaning elements may be substantially environmentally sealed in their respective cleaning element receptacles by a frangible sealing member that is pierced when the distal end connector of the coupling element is inserted into the recessed proximal portion of the respective cleaning element.

Such method(s) may further include using the automated transport arm to move the detachably-coupled cleaning member into a position such that the cleaning element is inserted into a test receptacle well of the test receptacle support structure, wherein the cleaning element is dimensioned such that an outer surface of the cleaning element conforms to an interior surface of the test receptacle well, where the cleaning element cleans, decontaminates and/or sterilizes the interior surface of the test receptacle well when inserted therein. In an exemplary embodiment, the test receptacle well has an open bottom, and the optical element comprising an optical fiber having an end positioned proximate to the open bottom of the test receptacle well, where the cleaning element cleans, decontaminates and/or sterilizes the end of the optical fiber when inserted into the test receptacle well.

In one embodiment, the detachably-coupled cleaning member comprises a first cleaning member, and the cleaning element of the first cleaning member comprises a first cleaning element, the method further comprising, after decoupling the first cleaning member from the working end of the automated transport arm, using the automated transport arm to detachably couple a second cleaning member to the working end of the automated transport arm, the second cleaning member comprising a second cleaning element; and move the detachably-coupled second cleaning member into a position such that the second cleaning element is inserted into the same test receptacle well of the test receptacle support structure. In such embodiment, the first cleaning element may be made of a different material (e.g., an adhesive material) than the second cleaning element (e.g., made of an absorbing material and carrying a cleaning and/or sterilizing fluid).

In accordance with the disclosed methods, a controller may control operation of the automated transport arm for causing the automated transport arm to detachably couple with a respective cleaning member, and to move the respective detachably-coupled cleaning member into a position proximate to and/or contacting the optical element based upon one or both of a (i) predetermined cleaning schedule, and (ii) sensed presence of particulates and/or other materials disposed on or over the optical element. The controller may further cause the automated transport arm to deposit respective decoupled cleaning members into a system waste output or a designated used cleaning member holder.

Other and further aspects and features of embodiments will become apparent from the ensuing detailed description in view of the accompanying figures.

The drawings illustrate the design and utility of the disclosed embodiments, in which similar elements are referred to by common reference numerals. These drawings are not necessarily drawn to scale. In order to better appreciate how the above-recited and other advantages and objects are obtained, a more particular description of the embodiments will be rendered, which are illustrated in the accompanying drawings. These drawings depict only typical embodiments and are not therefore to be considered limiting of its scope.

Before the present systems, methods, and apparatuses are described, it is to be understood that this disclosure is not limited to particular methods, components and materials described, as such methods, components and materials may vary. It is also to be understood that the terminology used herein is for purposes of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only in the appended claims.

Various components and sub-assemblies of embodiments of exemplary sample testing systems will now be described in conjunction with the accompanying figures. The figures are not necessarily drawn to scale, the relative scale of select elements may have been exaggerated for clarity, and elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be understood that the figures are only intended to facilitate the description of the embodiments, and are not intended as an exhaustive description of the disclosed embodiments or as a limitation on the scope of the disclosure, which is defined only by the appended claims and their equivalents. An aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated.

The term "about" generally refers to a range of numbers that one of skilled in the art would consider equivalent to the recited value (i.e., having the same function or result).

Thus, for example, references to "the method" includes one or more methods, and/or steps of the type described herein, which will become apparent to those persons skilled in the art upon reading this disclosure and so forth.

The term "comprising," which is used interchangeably with "including," "containing," "having," or "characterized by," is inclusive or open-ended language and does not preclude or exclude possible additional elements or acts. The phrase "consisting of' excludes any element, step, or ingredient not specified in the claim. The present disclosure contemplates exemplary embodiments of an apparatus and methods of use thereof corresponding to the scope of each of these phrases. Thus, a system, device or method comprising recited elements or steps contemplates particular embodiments in which the system, device or method consists essentially of or consists of those elements or steps.

<FIG> depict an exemplary cleaning member <NUM> for use in a sample testing system, according to embodiments disclosed herein. The cleaning member <NUM> includes a distal cleaning element <NUM> and a proximal coupling element <NUM>. As described below in greater detail, the respective cleaning and coupling elements <NUM> and <NUM> may be manufactured (e.g., molded) as separate components as depicted in <FIG>, and subsequently joined together, as depicted in <FIG> and <FIG>. Towards this end, the coupling element <NUM> has a distally projecting extension member <NUM> including a plurality of radially extending protuberances <NUM>. The extension member <NUM> and protuberances <NUM> are dimensioned to form an interference fit with a complementary-dimensioned interior cavity <NUM> of the cleaning element <NUM>, which is accessed through a proximal end opening <NUM> thereof. The material(s) used to make the cleaning element <NUM> and/or coupling element <NUM> are thus preferably sufficiently compliant relative to each other so that the coupling element <NUM> is fixedly-joined to the cleaning element <NUM> by inserting the extension member <NUM> through opening <NUM>, until the extension member <NUM> (including the protuberances <NUM>) makes a "snap-fit" connection within the cavity <NUM>. A radially outward ring <NUM> disposed on the coupling element <NUM> butts against a rim <NUM> surrounding the proximal opening <NUM> to prevent over-insertion of the extension member <NUM> into cavity <NUM>. It will be appreciated that alternative attachment mechanisms and configurations may be used to join together the cleaning and coupling elements <NUM> and <NUM>, such as a frictional fit, a weld, or an adhesive.

The respective cleaning and coupling elements <NUM> and <NUM> may be joined together prior to providing the (assembled) cleaning member <NUM> for use in a sample testing system, or alternatively the cleaning and coupling elements <NUM> and <NUM> may be provided as separate components that are joined together by the system at the time of using the cleaning member <NUM>. By way of example, a system testing system may include a first structure that holds one or more cleaning elements <NUM>, and a second structure that supports or holds one or more coupling elements <NUM>. At the time of use, a working end of an automated transport arm engages (i.e., detachably couples with) a coupling element <NUM> held in the second support structure, and transports the detachably-coupled coupling element <NUM> to a location proximate a cleaning element <NUM> held in the first support structure. The automated arm maneuvers the coupling element <NUM> to insert the extension member <NUM> thereof through the open proximal end <NUM> and interior cavity <NUM>, respectively, of the cleaning element <NUM>, to thereby form an interference fit to join the coupling element <NUM> to the respective cleaning element <NUM>. The fully assembled cleaning member <NUM> is then ready to use and already coupled to the automated transport arm. The cleaning elements <NUM> in the foregoing example may be environmentally sealed prior to use, e.g., in individually sealed receptacles, or in a sealed tray, in which a frangible member forming the respective seal is penetrated by the extension member <NUM>, as the coupling element <NUM> engages the cleaning element <NUM>.

Alternatively, the cleaning member <NUM> may be manufactured as an integral unit, e.g., in which the respective cleaning and coupling elements <NUM> and <NUM> are formed in their joined configuration using a co-molding process. In such embodiments, such as the below-described embodiments shown in <FIG>, it may still be desirable to environmentally seal the cleaning member(s) <NUM> prior to use, e.g., in individually sealed receptacles, or in a sealed tray, in which a frangible member forming the respective seal is penetrated by the working end of the automated transport arm as it engages the proximal end of the coupling element <NUM> of the cleaning member <NUM>.

By way of illustration and with specific reference to <FIG>, a proximal body portion <NUM> of the coupling element <NUM> forms an elongated, funnel-shaped interior recess <NUM> that is accessed through the open proximal end <NUM> of the coupling element <NUM>. The open end <NUM> of the coupling element <NUM> is bordered by a rim <NUM> having an axially facing surface. The recess <NUM> (best seen in <FIG>, <FIG> and <FIG>) is dimensioned to receive and releasably engage (mate) with the working end ("disposable tip interface" or "DiTi") <NUM> of an automated transport arm <NUM>. In particular, radially enlarged protrusions <NUM> and <NUM> disposed on the DiTi <NUM> form a frictional fit with an interior surface <NUM> of the interior recess <NUM> to thereby detachably-couple the DiTi <NUM> with the coupling element <NUM> when the DiTi <NUM> is inserted through the open end <NUM> thereof. The detachably-coupled components <NUM> and <NUM> may thereafter be de-coupled (i.e., detached) by action of a sleeve <NUM> that moves relative to the DiTi <NUM> by one or both of advancement of the sleeve <NUM> over the DiTi <NUM>, or by withdrawal of the DiTi <NUM> into the sleeve <NUM>, until a distal end <NUM> of the sleeve <NUM> contacts and engages the proximal rim <NUM> of the coupling element <NUM> to dislodge the coupling element <NUM> from the DiTi <NUM>.

As best seen in <FIG>, a plurality of longitudinally oriented linear ribs <NUM> are formed on the interior surface <NUM> of the coupling element <NUM>. While there are three linear ribs <NUM> depicted in the illustrated embodiments, alternative embodiments may have a fewer (i.e., <NUM> or <NUM>) or greater (i.e., <NUM> or more) amount of linear ribs <NUM> on the interior surface <NUM>. In further alternative embodiments, no linear ribs <NUM> are provided on the interior surface <NUM>, and the ribs <NUM> in the depicted embodiments should be considered optional. In embodiments having at least two linear ribs <NUM>, the ribs <NUM> are preferably spaced substantially equal distances apart from one another on the interior surface <NUM>. Accordingly, in the illustrated embodiments, the three ribs <NUM> are spaced approximately one hundred twenty degrees apart from each other on the interior surface <NUM>. The ribs <NUM> each protrude inward into recess <NUM> along their length, thereby decreasing the inner fitment diameter of the recess <NUM> to facilitate engagement of the DiTi protuberances <NUM> and <NUM> to the coupling element <NUM>. The ribs <NUM> may be beveled at an upper, or proximal, end thereof or otherwise preferably dimensioned to at least partially deform as the DiTi protuberances <NUM> and <NUM> are inserted into the recess <NUM>. In some embodiments, the amount of protrusion of the ribs <NUM> may gradually increase in size as the respective ribs approach the bottom of the recess <NUM> within the coupling member <NUM>. In the illustrated embodiments, the thickness of the ribs is increased at a radial-inward apex <NUM> within the recess <NUM>, and thereafter reduced, wherein a bottom portion <NUM> of each rib <NUM> is recessed to accommodate the frictional engaging protuberance <NUM> on the DiTi <NUM>. Alternatively, or in addition thereto, in certain embodiments, the linear ribs <NUM> may gradually increase in overall thickness as they approach the bottom of the recess. Thus, a gradual increase in thickness and/or radial geometry is contemplated for the gradual tapering of the one or more linear ribs <NUM>, which additionally serves to center the DiTi <NUM> as it is inserted through open end <NUM> of the coupling element <NUM>, and into recess <NUM>.

One or more longitudinal indentations, or recesses <NUM>, are disposed on, and extend along at least part of the length of, the exterior surface <NUM> of the coupling element <NUM>. The recesses <NUM> may be formed in any shape such as, for example, concave, notched, squared, etc. In various embodiments, the length of each of the one or more recesses <NUM> is aligned with (i.e., in direct opposition), and is approximately the same length as, a corresponding linear rib <NUM> disposed on the interior surface <NUM>. Thus, the illustrated embodiment has three exterior linear recesses for a one-to-one relationship with the respective three linear ribs <NUM> on the interior surface <NUM>. The coupling of an interior surface linear rib <NUM> with an exterior surface recess <NUM> enhances the predictability of the frictional attachment of the coupling element <NUM> with the DiTi <NUM> of the automated transport arm <NUM>. In particular, as the DiTi <NUM> of the transport arm <NUM> is lowered into the recess <NUM> of the coupling element <NUM>, the distal end protuberances <NUM> and <NUM> of the DiTi <NUM> contact and press against the linear ribs <NUM>, thereby causing the coupling element <NUM>, and in particular the one or more recesses <NUM>, to flex and/or expand radially outward with respect to the axial center thereof to accommodate the DiTi <NUM> and enhance its frictional attachment or "mating" of the transport arm <NUM> with the coupling element <NUM>.

A plurality of protrusions <NUM> extend radially outward from proximal rim <NUM> surrounding the proximal end opening <NUM> of the coupling element <NUM>. The protrusions <NUM> are preferably substantially equal distances apart from one another on the rim <NUM>, and facilitate stacking and/or docking of the coupling elements <NUM> (as separate components) and/or the fully assembled cleaning members <NUM> within a well of a multi-well tray for use in an automated sample testing system (as described herein).

The coupling element <NUM> may be molded from a number of different polymer and heteropolymer resins, including, but not limited to, polyolefins (e.g., high density polyethylene ("HDPE"), low density polyethylene ("LDPE"), a mixture of HDPE and LDPE, or polypropylene), polystyrene, high impact polystyrene and polycarbonate. Although LDPE is a softer, more malleable material than HDPE, the softness of LDPE provides greater flexibility in the distally projecting extension member <NUM> and protuberances <NUM>, for securably engaging the cleaning element <NUM> within the cavity <NUM>. Such added flexibility may also facilitate the frictional engagement of the working end <NUM> of the transport arm <NUM> within the proximal interior cavity <NUM> of the coupling element <NUM>. In a presently preferred embodiment, the coupling element <NUM> is formed out of polypropylene ("PP"). Regardless of the type or mixture of the respective chosen materials, the cleaning element <NUM> and the coupling element <NUM> are preferably made using a known molding process, such as by injection, compression, transfer or RTV molding. The elements <NUM> and <NUM> may be molded as separate components that are later joined together, or as a single component manufactured using a known co-molding (or "over-molding") process in which the cleaning element <NUM> is molded onto the extension member <NUM> of the coupling member <NUM>, so that the two components are joined together in the manufacturing process.

The cleaning element <NUM> has a uni-body construction that may be formed using a known injection molding process. The materials used in the molding process should be oil free and any mold-release agents used during the molding process are preferably limited to ones that do not leave an oily residue on the surface <NUM> of the cleaning element <NUM>. In various embodiments, one or more cleaning elements <NUM> may be made out of an adhesive material, such as (without limitation) silicone, platinum cured silicone, thermoplastic polyurethane, thermoplastic elastomer, thermoplastic rubber, or a gel. A preferred adhesive material is one that is tacky, but does not leave a residue on surfaces which it contacts.

Alternatively or additionally, one or more cleaning elements <NUM> may be made out of a material that generates a static attraction to particulates and/or other materials that can interfere with the transmission by the optical element of electromagnetic radiation emitted or reflected by the sample, such as (without limitation) silicon, polyvinyl chloride, polypropylene, polyethylene, polyurethane, polyester or polystyrene. Notably, some of the foregoing materials that are adhesive also generate a static attraction to unwanted debris.

Alternatively or additionally, one or more cleaning elements <NUM> may be made out of an absorbent material capable of retaining a fluid cleaning and/or sterilizing substance, and of applying the retained fluid to the surface of the respective structure being cleaned and/or sterilized. Such absorbent materials include but are not limited to hydrophilic materials, and may also include hydrophobic materials such as PP and other plastics. Additional examples of absorbent materials that may be used for forming the cleaning element <NUM> include, without limitation, porous plastic materials in a sponge or foam form made of materials such as PP, HDPE, LDPE, polytetrafluoroethylene ("PTFE"), polyvinylidene fluoride ("PVDF"), ethylene vinyl acetate ("EVA"), Porex® polymers, cellulose fibers (such as cotton fabric or cloth), and polymicro fibers. Exemplary fluid cleaning and/or sterilizing substances that may be used include, without limitation, isopropyl alcohol, ethyl alcohol, diluted hydrochloric acid (e.g., <NUM>% solution), oxalic acid, diluted sodium hydroxide (e.g., <NUM>% solution), and diluted sodium hypochlorite (e.g., <NUM>% solution). A preferred cleaning and/or sterilizing fluid should be a composition that is easily removed (e.g., by reabsorption or evaporation), and should not leave a residue on the respective optical element after contact. Certain fluids should not be used, such as window cleaning fluids with ammonia, gasoline, denatured alcohol, carbon tetrachloride and or acetone, since such fluids may damage the respective optical element and/or sample test receptacle well. The cleaning and/or sterilizing fluid is kept in a separate receptacle from the absorbent cleaning elements <NUM>, which are at least partially inserted into the cleaning and/or sterilizing fluid at the time of use. Alternatively, the absorbent cleaning elements <NUM> may be pre-soaked with the cleaning and/or sterilizing fluid prior to being supplied for use.

In various embodiments, the cleaning element <NUM> may have different shapes, dimensions and configurations as best suited for performing the cleaning and/or sterilizing functions of the sample testing system in which it is used. For example, cleaning elements <NUM> of selected cleaning members <NUM> may be specially shaped and/or dimensioned for reaching and cleaning and/or sterilizing particular types of optical elements, test receptacle wells, and other components of a sample testing system in which they are used. The distal end <NUM> of the cleaning element <NUM> may be flat or curved, and preferably is at least somewhat compressible to avoid damaging components of the test system during the cleaning process.

In some embodiments, a sample testing system may be provided with multiple types of cleaning members <NUM>, including one or more cleaning members <NUM> having cleaning elements <NUM> made of a first (e.g., adhesive) material, and one or more additional cleaning members <NUM> having cleaning elements <NUM> made of a second (e.g., absorbent) material. For example, a sample test system may be provided with a one or more cleaning members <NUM> having adhesive cleaning elements <NUM>, and one or more cleaning members <NUM> having absorbent cleaning elements <NUM> that retain a cleaning and/or sterilizing fluid, wherein a cleaning member <NUM> having an adhesive cleaning element <NUM> is used to perform an initial cleaning of one or more optical elements, and a cleaning member <NUM> having a fluid-retaining cleaning element <NUM> is thereafter used to perform a secondary (i.e., finishing") cleaning of the same one or more optical elements.

<FIG> and <FIG> are respective cross-sectional side elevation and cross-sectional side perspective views of the DiTi <NUM> of the automated transport arm <NUM> inserting an already detachably-coupled cleaning member <NUM> into a test receptacle well <NUM> of a test receptacle holder <NUM> positioned on a processing deck of a sample testing system (described below in greater detail), wherein the distal end surface <NUM> of the cleaning element <NUM> contacts an upward axial facing end surface <NUM> of an optical fiber <NUM> surrounded by a sleeve <NUM>, positioned proximate to an open bottom portion <NUM> of the test receptacle well <NUM>. By way of non-limiting example, the test receptacle holder <NUM> comprises a plurality of test receptacle wells <NUM> (two adjacent wells <NUM> or shown in <FIG> and <FIG>), and the sample testing system may be provided with a plurality of similar test receptacle holders <NUM>, each having a plurality of test receptacle wells <NUM>. It should be appreciated that, in alternate embodiments of sample testing systems, a test receptacle holder may have a different construct, for example, a platform for holding a microtiter plate.

The automated transport arm <NUM>, and the DiTi <NUM> in particular, are configured to detachably couple a fully assembled cleaning member <NUM> located in a cleaning member well of a nearby cleaning member holder, (such as cleaning member well <NUM> of the cleaning member storage tray <NUM> shown in <FIG>, described below), or to otherwise first detachably couple a coupling element <NUM> located in a coupling element holder (not shown) and thereafter join a cleaning element <NUM> located in a separate (e.g., environmentally sealed) cleaning element holder (also not shown) to the already detachably-coupled coupling element <NUM> to thereby have a detachably-coupled cleaning member <NUM>. In either case, the transport arm <NUM> maneuvers the DiTi <NUM> to insert the detachably-coupled cleaning member <NUM> into the test receptacle well <NUM>, as shown in <FIG> and <FIG>, such that a distal tip <NUM> of the cleaning element <NUM> is contacting (to thereby clean and/or sterilize) the axial facing distal end <NUM> of an optical fiber <NUM> positioned proximate to the open bottom end <NUM> of the test receptacle well <NUM>. It should be appreciated that it is not necessarily required for the distal tip <NUM> of the cleaning element <NUM> to make physical contact with the axial facing end <NUM> of the optical fiber <NUM>, for example, if the cleaning element <NUM> comprises a material that generates a static attraction to clean the optical fiber end <NUM>, as described above.

It should be appreciated that optical fiber <NUM> can be one of a plurality of optical fibers (not shown in the Figures) employed by the sample testing system to conduct optical interrogation of samples contained in test receptacles seated in the respective test receptacle wells <NUM>. In particular, the optical fiber(s) <NUM> transmit electromagnetic radiation (which may or may not be in the visible light spectrum) that is emitted and/or reflected by the sample, as is explained in detail in the above-incorporated patent applications. It should be appreciated that optical elements other than optical fibers may be used for this purpose in alternate sample testing systems, and in particular other optical elements having a protective surface, such as (without limitation) a fluorometer comprised of fixed lenses and filters, a photomultiplier tube ("PMT"), and/or other optical elements used in the field of biological sample testing, such as a lens, window, mirror, reflector, filter, film, and/or the like disposed between the sample and an illuminator (e.g., lasers, LEDs, tungsten, halogen, mercury arc, xenon arc, metal halide lamps) or detector (PMT, CCD, CMOS, photodiodes, photodiode array). Regardless of the type of optical element(s) that may be employed by a sample testing system, it is critical that the optical pathway extending between, and including, the end surfaces of the respective optical element and test receptacle be free and clear of any debris that may interfere with the optical interrogation process. Thus, the cleaning members <NUM> of various embodiments may be suitably modified to accommodate the cleaning and/or sterilizing alternative types of optical elements and/or test receptacle configurations that may be employed in various sample testing systems.

Although practice of the disclosed embodiments is not limited to the cleaning element <NUM> having any particular shape or dimensions, in the illustrated embodiment, the outer surface <NUM> of the cleaning element <NUM> and the interior surface <NUM> of the test receptacle well <NUM> have complementary, generally frustoconical shapes. In this manner, the cleaning element <NUM> advantageously contacts to clean and/or sterilize the interior surface <NUM> of the test receptacle well <NUM> at the same time that the distal end <NUM> of the cleaning element <NUM> contacts to clean and/or sterilize the end surface <NUM> of the optical fiber <NUM>.

<FIG> depicts one embodiment of a sample processing instrument deck <NUM> of a sample testing system, in which an automated transport arm assembly (such as the below-described automated transport arm gantry <NUM> and associated transport arms <NUM> and <NUM> shown in <FIG>) is omitted for clarity. The sample processing instrument deck <NUM> includes a dozen test receptacle holders <NUM>, each holder <NUM> having five test receptacle wells <NUM>, for a total of sixty test receptacle wells <NUM>. The individual receptacle holders <NUM> are best seen in the partial perspective view of an alternate embodiment sample processing instrument deck <NUM>' depicted in (below-described) <FIG>. Reference is made to the above-incorporated<CIT>, which discloses additional details of an exemplary sample processing instrument deck, and of the operation of an exemplary sample testing system of which the instrument deck is a part.

<FIG> depicts an exemplary automated transport system gantry <NUM>, including a pair of transport arms <NUM> and <NUM> (transport arm <NUM> is also shown in <FIG>). The transport system gantry <NUM> can be employed in embodiments of a sample processing instrument deck, including embodiments incorporating and using the cleaning members <NUM> disclosed herein (such as instrument deck <NUM>' of below-described <FIG>). While the depicted transport arms <NUM> and <NUM> are different in appearance from the automated transport arm <NUM> (including the DiTi interface and sleeve <NUM>/<NUM>) depicted in <FIG>, <FIG> and <FIG>, the operation and functionality of the transport arms <NUM>, <NUM> is substantially the same as for transport arm <NUM>. Thus, the transport system gantry <NUM>, including transport arms <NUM> and <NUM>, is illustrated and described herein for purposes of better understanding the operation of the automated transport arm <NUM> and DiTi/sleeve <NUM>/<NUM> depicted in the above-described embodiments of <FIG>.

Transport arms <NUM> and <NUM> may be used for detachably coupling and transporting objects, such as the cleaning members <NUM>, along two axes (i.e., X and Y) in order to position the detachably-coupled objects at respective targeted locations of a sample processing instrument deck (e.g., instrument deck <NUM>' of <FIG>). In particular, the transport system gantry <NUM> can be used for detachably coupling, moving, inserting, and detaching the cleaning members <NUM>, as described above with respect to the transport arm <NUM> of the embodiments of <FIG>. Towards this end, transport arm <NUM> is movable along a first X axis rail <NUM>, and transport arm <NUM> is movable along a second X axis rail <NUM>. The X axis rails <NUM> and <NUM> are, in turn, both movable along a pair of Y axis rails <NUM> and <NUM>. In this manner, the respective X rails <NUM> and <NUM>, and Y axis rails <NUM> and <NUM>, collectively facilitate movement of the transport arms <NUM> and <NUM> in order to position the respective arms above respective targeted objects to be detachably coupled and moved to targeted locations for positioning (e.g., inserting) and (optionally) decoupling the detachably-coupled objects. The transport arms <NUM> and <NUM> are configured to move vertically (i.e., along their "Z axis") for lowering or raising a respective detachably coupled object, e.g., for inserting a detachably-coupled cleaning member <NUM>, relative to a targeted object underlying the respective arm. A controller (not shown) is configured to control operation of, inter alia, the transport system gantry <NUM>, including arms <NUM> and <NUM>.

In alternate embodiments, an automated transport arm for use in the disclosed embodiments herein may be an articulating (e.g., robotic) arm that pivots about a fixed base, although this is not necessary for practicing the disclosed embodiments.

<FIG> depict an exemplary cleaning member storage tray <NUM> comprising a uni-body structure <NUM> that is molded out of a same or similar plastic material used to form the cleaning member coupling element <NUM>, although other suitable materials and manufacturing techniques may be used for making the cleaning member storage tray <NUM>. The storage tray body <NUM> defines a five-by-five array (i.e., twenty-five total) inwardly recessed cleaning member wells <NUM>. The storage tray body <NUM> has a box-like outer shape, including four continuous sidewalls <NUM> that meet at a top surface <NUM> in which the respective openings of the cleaning member wells <NUM> are disposed. An outwardly protruding lip <NUM> substantially circumscribes a bottom end portion of the four sidewalls <NUM>, as best seen in <FIG>. Opposing side walls 430A and 430B of the storage tray body <NUM> have a pair of laterally spaced apart slots <NUM> extending from respective openings <NUM> in the bottom lip <NUM> of the sidewall 430A, 430B upward to an apex, the slots <NUM> defining flexible tabs 438A and 438B in sidewalls 430A and 430B, respectively. The bottom edge of tabs 438A and 438B have respective outwardly extending latching flanges 435A and 435B. The tabs may be flexed into the storage tray body <NUM> by inwardly depressing the latching flanges 435A and 435B into the storage tray body <NUM>.

An exemplary cleaning member <NUM> is seated in a respective cleaning member receptacle 426A in a corner of the storage tray <NUM>. For illustration of an alternative embodiment, there are four longitudinally oriented linear ribs <NUM> formed on the interior surface <NUM> of the coupling element <NUM> of the cleaning member of <FIG>. The linear ribs <NUM> are spaced substantially equal distances apart from one another on the interior surface <NUM> of the cleaning member <NUM> of <FIG>, and are the same in dimension and features as the linear ribs <NUM> of cleaning member <NUM> of <FIG>.

As best seen in <FIG>, the cleaning member wells <NUM> of the storage tray <NUM> include a lower portion <NUM> having an interior surface <NUM> configured and dimensioned to snuggly seat the distal cleaning element <NUM> of the cleaning member <NUM>, and an upper portion <NUM> having a plurality of spaced apart catch members <NUM> that receive and support the coupling element <NUM>. The body <NUM> and respective storage wells <NUM> of the cleaning member storage tray <NUM> are dimensioned and configured such the proximal end rim <NUM> of the cleaning member coupling element <NUM> is approximately co-extensive with the top surface <NUM> of the storage tray <NUM>. In this manner, the proximal open end <NUM> of the cleaning member coupling element <NUM> is readily accessible for engagement by an automated transport arm, such as the DiTi <NUM> of transport arm <NUM> depicted in <FIG>, <FIG> and <FIG>. For ease in illustration, no transport arm is depicted in <FIG>.

The top surface <NUM> of the storage tray <NUM> may (optionally) be substantially environmentally sealed by a frangible sealing member (not shown) that protects and keeps the cleaning elements <NUM> of the cleaning members <NUM> in fresh and moist (if appropriate) condition within the wells <NUM>, until they are ready to be used. In such embodiments, the distal end of the DiTi <NUM> penetrates the respective sealing member as it is inserted into the proximal opening <NUM> of the cleaning member coupling element <NUM>. In an alternative embodiment, the cleaning member wells <NUM> may be individually sealed, so that when a seal is broken to access and detachably couple with a respective cleaning member <NUM>, cleaning members <NUM> seated in neighboring wells <NUM> remain substantially environmentally sealed. <FIG> are side views, and <FIG> is a bottom view, respectively, of the cleaning member storage tray <NUM>.

<FIG> depicts an exemplary cleaning member storage tray holder <NUM> having a uni-body structure <NUM> molded out of a same or similar plastic material used to form the cleaning member coupling element <NUM> and/or storage tray <NUM>, although other suitable materials and manufacturing techniques may be used for making the tray holder <NUM>. The tray holder body <NUM> defines a side-by-side pair of recessed bays 462A and 462B, each bay 462A and 462B configured and dimensioned to receive a respective cleaning member storage tray <NUM> therein. A storage tray <NUM> is seated in bay 462A, with its horizontal latching flanges 435A and 435B extending through respective corresponding horizontal mating slots 465A and 465B disposed in opposing exterior walls 461A and 461B of the tray holder body <NUM>. The latching flange 435B and horizontal mating slot 465B are not visible in <FIG>. However, bay 462B is also provided with opposing horizontal mating slots 464A and 464B (both visible in <FIG>) in the opposing walls 461A and 462B for latching a cleaning member tray <NUM> in the same manner.

It should be appreciated that the cleaning member storage tray <NUM> can be snap fit into the bay 462A due to the flexibility and resilience of tabs 438A and 438B of the storage tray body <NUM>. In particular, tabs 438A and 438B of the storage tray <NUM> may be depressed or squeezed towards each other such that the tabs are displaced into the tray body <NUM> to allow the storage tray <NUM> to be fully inserted into the bay 462A. When the storage tray <NUM> is completely inserted into the bay 462A, the latching tabs 435A and 435B are aligned with the slots 465A and 465B, and the tabs 438A and <NUM>8B self-restore to a non-depressed configuration, causing the latching flanges 435A and 435B to at least partially extend into the respective mating slots 465A and 465B to thereby latch the storage tray <NUM> in bay 462A.

A teach member <NUM> is provided in a center area of bay 462B, and is used by the automated transport arm (not shown) to locate items it needs to interface with in the sample processing instrument deck (e.g., instrument deck <NUM>' of <FIG>) on which the sample receptacle tray holder <NUM> is mounted. The teach feature <NUM> in this embodiment has a box-like shape, although other shapes may be used. The automated transport arm will locate the feature by repeatedly driving down its distal tip until it force senses from the top to falling off the side. Once the transport arm locates all four sides of the teach feature <NUM>, it interpolates the center position of the teach feature and knows the coordinates in X, Y, Z.

Referring to <FIG>, the cleaning member tray holder <NUM>, including a cleaning member storage tray <NUM> having twenty-five cleaning member wells <NUM>, is shown installed by bracket <NUM> in an exemplary sample processing instrument deck <NUM>' of a sample testing system. Except for the added cleaning member tray holder <NUM> (and cleaning member storage tray <NUM> mounted thereon) instrument deck <NUM>' is essentially identical to instrument deck <NUM> of <FIG>, including the provisioning and arrangement of a dozen test receptacle holders <NUM>, each test receptacle holder <NUM> having five test receptacle wells <NUM> for seating sample test receptacles containing biological samples to be optically interrogated. One or more an automated transport arms (such as the above-described automated transport arm <NUM> of the embodiment of <FIG>, or the above-described transport arms <NUM> and <NUM> of <FIG>) are associated with the instrument deck <NUM>' (omitted from <FIG> for clarity).

It should be appreciated that the cleaning member storage tray(s) <NUM> may be manually placed into (and removed from) the storage tray holder <NUM>. In alternative embodiments, the cleaning member storage tray(s) <NUM> may be robotically placed into (and removed from) the storage tray holder <NUM> by the respective automated transport arm employed for transporting the cleaning members <NUM>. In the latter case, a modification may be made to/in the top surface of the tray to provide a coupling element for the automated transport arm, such as by converting the center-most cleaning member receptacle <NUM> into a recess configured for detachably coupling with the automated arm. The instrument deck <NUM>' preferably also includes a waste output or other designated "used" cleaning member holder (not shown), configured to at least temporarily hold used cleaning members <NUM>. Alternatively, the used cleaning members <NUM> can be returned to the same or a different cleaning member receptacle well <NUM> from which they were originally taken.

In accordance with the disclosed embodiments, a controller (not shown) controls operation of an automated transport arm associated with the instrument deck <NUM>' (not shown in <FIG>) for causing the automated transport arm to detachably couple with a respective cleaning member <NUM> (not shown in <FIG>) held in a cleaning member receptacle <NUM> of the storage try <NUM>, and to move the respective detachably-coupled cleaning member <NUM> into a position proximate to and/or contacting an optical element (e.g., the distal end of an optical fiber such as shown in <FIG> and <FIG>) underlying an open bottom end of one of the test receptacle wells <NUM> based upon one or both of a (i) predetermined cleaning schedule, and (ii) sensed presence of particulates and/or other materials disposed on or over the optical element. The controller may further cause the automated transport arm to deposit respective decoupled cleaning member <NUM> into a system waste output or a designated used cleaning member holder.

Claim 1:
A sample testing system, comprising:
a test receptacle support structure (<NUM>) comprising a test receptacle well (<NUM>) configured to have a test receptacle seated therein;
an optical element positioned for transmitting electromagnetic radiation emitted or reflected by a sample disposed in the test receptacle supported by the test receptacle support structure (<NUM>);
an automated transport arm (<NUM>); and
a controller that is configured to control operation of the automated arm (<NUM>);
characterized in that the sample testing system further comprises:
a cleaning member (<NUM>)) comprising a proximal coupling element (<NUM>) joined to a distal cleaning element (<NUM>), the coupling element (<NUM>) having a proximal end portion configured to releasably mate with a distal working end portion of the automated transport arm (<NUM>); and in that
the automated transport arm (<NUM>) is configured to:
detachably couple the cleaning member (<NUM>), move the detachably-coupled cleaning member (<NUM>) into a position proximate to and/or contacting the optical element, such that the cleaning member thereby cleans and/or sterilizes the optical element; and
decouple the cleaning member (<NUM>); and
the controller is configured to control operation of the automated transport arm (<NUM>) for causing the automated transport arm to detachably couple with the cleaning member (<NUM>), and to move the detachably-coupled cleaning member (<NUM>) into a the position proximate to and/or contacting the optical element based upon one or both of a (i) predetermined cleaning schedule, and (ii) sensed presence of particulates and/or other materials disposed on or over the optical element; and
wherein the controller is configured to control operation of the automated transport arm for causing the automated transport arm to detachably couple the cleaning member to the working end portion of the transport arm by:
(i) detachably-coupling the proximal end portion of the coupling element (<NUM>) to the working end of the transport arm; and
inserting a distal end connector of the coupling element into a recessed proximal portion of the cleaning element to thereby attach the cleaning element to the coupling element; or
(ii) detachably coupling a fully assembled cleaning member located in a cleaning member well (<NUM>) of a nearby cleaning member holder (<NUM>), the sample testing system comprising the cleaning member holder.