Patent Publication Number: US-2022221333-A1

Title: Photometer optical coupling for a dual incubation ring using a periscope design

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims the benefit of U.S. Provisional Patent Application No. 62/893,063, filed Aug. 28, 2019, which is incorporated by reference herein in its entirety. 
    
    
     TECHNICAL FIELD 
     The present invention relates generally to systems, methods, and apparatuses for coupling photometers to an incubation ring for use in automated clinical chemistry analyzers in vitro diagnostics applications. 
     BACKGROUND 
     In vitro diagnostics (IVD) allows labs to assist in the diagnosis of disease based on assays performed on patient fluid samples. IVD includes various types of analytical tests and assays related to patient diagnosis and therapy that can be performed by analysis of a liquid sample taken from a patient&#39;s bodily fluids, or abscesses. These assays are typically conducted with automated clinical chemistry analyzers (analyzers) onto which fluid containers, such as tubes or vials, containing patient samples, have been loaded. The analyzer extracts a liquid sample from the vial and combines the sample with various reagents in special reaction cuvettes or tubes (referred to, generally, as reaction vessels). 
     A modular approach is often used for analyzers. Some larger systems include a lab automation system that can shuttle patient samples between one sample processing module and another module. These modules include one or more stations, including sample handling stations and testing stations. Testing stations are units that specialize in certain types of assays and provide predefined testing services to samples in the analyzer. Exemplary testing stations include immunoassay (IA) and clinical chemistry (CC) stations. In some laboratories, typically including smaller labs, these testing stations can be provided as independent/standalone analyzers or testing modules, allowing an operator to manually load and unload individual samples or trays of samples for CC or IA testing at each station in the lab. 
     At the heart of a typical CC analyzer/module is an incubation ring assembly. To perform the above-described assays, the reactions need to take place at a well-controlled temperature range, typically coinciding with the nominal temperature of the human body samples. The incubator ring rotates relative to a fixed base, typically driven by a motor affixed to the base that drives a gear ring or belt on the moving ring. This allows assays of varying length to be performed in parallel, allowing some cuvettes to receive analytes/reagents, some receive sample aliquots, some to be analyzed, some to be washed, etc., simultaneously. One assay of particular relevance to the present application is photometric analysis. This analysis is performed using photometers coupled to the ring that pass light through sample tubes as they move on the ring. 
     In some systems, to regulate temperature, the base is commonly heated with a conventional heating element driven by a controller that receives thermal feedback from a temperature sensor in thermal contact with the base. The thermally controlled base heats the air gap between the base and the incubator ring, which heats the cuvette. An enclosure is provided to help insulate the entire volume of air inside. By residing in the thermally regulated air, the ring maintains the set temperature when in a steady state condition. 
     In other systems, to regulate temperature, the dual reaction rings are filled with water, which is heated by an enclosed heater element driven by a controller that receives thermal feedback from a temperature sensor in contact with the water. This heats the water bath to the desired reaction temperature. The reaction cuvettes are in direct contact with the water bath, and move in a constant motion to maintain the set point in a steady state condition. 
     Recently, a dual incubation ring design has been developed to increase the throughput of the CC modules. In contrast to a conventional single ring design, a dual incubation ring has two rings: an inner ring and a larger, outer ring. Each ring is capable of transporting samples through different assays independently. However, current dual incubation ring designs do not allow for the use of a direct optical coupling of the photometer light source, and light detector components due to space constraints. 
     SUMMARY 
     Embodiments of the present invention address and overcome one or more of the above shortcomings and drawbacks, by providing methods, systems, and apparatuses related to coupling of photometers to a dual incubation ring using a periscope design. 
     According to some embodiments, a system for coupling photometers to an incubation ring for use in in vitro diagnostics comprises one or more light sources, an incubation ring assembly, and two photometers. An incubation ring assembly comprises an internal trough and an external trough. Each trough comprises (a) an internal wall comprising an internal aperture and (b) an external wall comprising an external aperture. A first photometer is positioned with respect to the internal trough. This first photometer comprises: a first optics housing directing light from the light sources through the external aperture of the internal trough, and a first detector positioned to receive the light through the internal aperture of the internal trough. A second photometer is positioned with respect to the external trough. This second photometer comprises a second optics housing directing the light from the light sources through the internal aperture of the external trough, and a second detector positioned to receive the light through the external aperture of the external trough. 
     According to another aspect of the present invention, a photometer system comprises an optics housing and a detector. The optics housing comprises two channels and one or more reflecting surfaces. The first channel receives a fiber optic cable transmitting light from one or more light sources. The second channel is connected to the first channel at an angle. The reflecting surfaces redirect the light from the fiber optic cable to the second channel. The detector is oriented parallel with respect to the second channel of the optics housing and the detector generates a photometric measurement based on the light received from the optics housing. 
     In other embodiments, a method of testing a sample in an in vitro diagnostics system includes receiving a light signal from a fiber optic cable in a vertical channel of an optics housing. The light signal is directed onto a reflecting surface of the optics housing such that the light signal is reflected at an angle and through a first aperture of a trough of an incubation ring assembly. The light signal is received by a detector through a second aperture of the trough of the incubation ring assembly. Then, the light signal is processed to determine one or more photometric measurements. 
     Additional features and advantages of the invention will be made apparent from the following detailed description of illustrative embodiments that proceeds with reference to the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The foregoing and other aspects of the present invention are best understood from the following detailed description when read in connection with the accompanying drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments that are presently preferred, it being understood, however, that the invention is not limited to the specific instrumentalities disclosed. Included in the drawings are the following Figures: 
         FIG. 1  illustrates system for coupling photometers to an incubation ring for use in in vitro diagnostics according to some embodiments; 
         FIG. 2  provides an example of how the optics housing can be mounted on a base plate in some embodiments of the present invention; 
         FIG. 3  shows an example of how screws can be used mounting the detector on the Base Plate  125 , according to some embodiments; 
         FIG. 4  shows installation of an example optics housing on the external ring of incubation ring assembly; 
         FIG. 5  shows an overhead view of the fully mounted optics housing presented in  FIG. 4 ; 
         FIG. 6  shows an overhead view of an example optics housing and a detector positioned on the external ring of incubation ring assembly; 
         FIG. 7A  shows a first example configuration for coupling photometers to a dual incubation ring, according to some embodiments; 
         FIG. 7B  shows an alternate implementation of the first example shown in  FIG. 7A , with the light sources mounted above a baseplate; 
         FIG. 8A  shows a second example configuration for coupling photometers to a dual incubation ring, according to some embodiments; 
         FIG. 8B  shows an alternate implementation of the second example shown in  FIG. 8A , with the light sources mounted above a baseplate; 
         FIG. 9A  shows a third example configuration for coupling photometers to a dual incubation ring, according to some embodiments; 
         FIG. 9B  shows an alternate implementation of the third example shown in  FIG. 9A , with the light sources mounted above a baseplate; 
         FIG. 10A  shows a fourth example configuration for coupling photometers to a dual incubation ring, according to some embodiments; and 
         FIG. 10B  shows an alternate implementation of the fourth example shown in  FIG. 10A , with the light sources mounted above a baseplate. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention relates generally to methods, systems, and apparatuses related to the coupling of a photometer to a dual incubation ring using a periscope design. More specifically, with the designs disclosed herein, the light source (e.g., halogen, LED or hybrid) is located below the baseplate in any desired space location, and coupled by a fiber optic cable to a periscope assembly between the dual incubation rings in a minimal space. The light is focused from the fiber by a set of aspheric collimating lenses, and then turned at an angle (e.g., 45 degrees) by an optical mirror, parabolic mirror, dichroic lens, or prism to hit the target aperture for proper beam alignment to pass through the optical cuvettes to hit the detector. In some embodiments, this can be done to supply both sides of the ring using a single light source, using a bifurcated optical fiber. Likewise, in some embodiments, the general design disclosed herein may be implemented with a single light source, and single leg optical fiber. 
       FIG. 1  illustrates a system  100  for coupling photometers to an incubation ring for use in in vitro diagnostics according to some embodiments. An Incubation Ring Assembly  105  comprises an External Trough  105 A and an Internal Trough  105 B. Each trough comprises two apertures. For clarity,  FIG. 1  only shows these apertures with respect to the Internal Trough  105 B. Specifically, the Internal Trough  105 B has a First Aperture  105 C on the external wall (i.e., the wall farthest from the center point of the Incubation Ring Assembly  105 ) and a Second Aperture  105 D on the internal wall (i.e., the wall closest to the center point of the Incubation Ring Assembly  105 ). 
       FIG. 1  shows a photometer assembly that comprises an Optics Housing  110  and a Detector  115 . One or more light sources (not shown in  FIG. 1 ) transmit light to the Optics Housing  110  via a Fiber Optic Cable  120 . As is generally understood in the art, fiber optics allows variable length, flexible cables to transmit light over great distances. Thus, the use of fiber optics allows the light source to be located below the Incubation Ring Assembly  105  as desired to meet spacing constraints, meet manufacturability specifications, allow service access, etc. 
     The Optics Housing  110  is based on a “periscope” design that allows the Optics Housing  110  to fit in a minimal space location between troughs of the Incubation Ring Assembly  105 . Within the Optics Housing  110 , a Vertical Channel  110 A receives the Fiber Optic Cable  120 . Aspheric Collimating Lenses  110 D focuses the light from the Fiber Optic Cable  120  on a Reflecting Surface  110 C. This Reflecting Surface  110 C may comprise, for example, an optical mirror, parabolic mirror, dichroic lens, or a prism. The Reflecting Surface  110 C redirects the light across a Horizontal Channel  110 B and through the First Aperture  105 C of the Internal Trough  105 B. 
     Continuing with reference to  FIG. 1 , the Detector  115  is positioned to receive the light through the Second Aperture  105 D of the Internal Trough  105 B. During an operation of the system  100 , a vessel holding a sample moves through the Internal Trough  105 B. The vessel may be transparent or include a window through which the light passes as it is transmitted from the Optics Housing  110  to the Detector  115 . As would be understood by one skilled in the art of photometric measurement, one method of identifying organic and inorganic compounds in a test sample is to introduce chemical reagents that react to specific ions in the sample causing the ions to change color. When light is passed through a sample colored by a reagent, one or more colors are absorbed based on the ion present. The Detector  115  can then analyze the light that is not absorbed to infer what compounds are present in the sample. 
     In  FIG. 1 , the components of the photometer are mounted on a Base Plate  125  below the Incubation Ring Assembly  105 . More specifically, the Incubation Ring Assembly  105  comprises an Upper Surface  130 A defined by open sections of the External Trough  105 A and the Internal Trough  105 B and a Lower Surface  130 B located opposite to the Upper Surface  130 A. A Base Plate  125  is positioned below the Lower Surface  130 B of the Incubation Ring Assembly  105 . This Base Plate  125  is mounted on lower components of the analyzer system such that the Base Plate  125  rotates with the Incubation Ring Assembly  105  while sample analysis is being performed by the system. The Optics Housing  110  and the Detector  115  are then mounted to the Base Plate  125 . In embodiments where a second photometer is positioned with respect to the External Trough  105 A, those components can likewise be mounted on the same Base Plate  125 . It should be noted that the use of single mounting baseplate for both the Optics Housing  110  and the Detector  115  allows for precise alignments, and ease of manufacturability. 
       FIG. 2  provides an example of how the Optics Housing  110  can be mounted on a Base Plate  125  in some embodiments of the present invention. A Seal  215  is used at the coupling of the Optics Housing  110  to the Incubation Ring Assembly  105  to provide a tight connection while minimizing vibrations. This Seal  215  may be, for example, a u-shaped rubber gasket. The Optics Housing  110  comprises two cavities sized to receive Pins  205 . These Pins  205  are then inserted into Pin Housing  210  in the Base Plate  125  to complete the mounting. In some embodiments, the Pin Housing  210  is moveable. Thus, the position of the Optics Housing  110  may be aligned with respect to the Detector  115  and the apertures of the Incubation Ring Assembly  105 . Once the components are fully aligned, the position of the Pin Housing  210  can be fixed. Then, the components can be disassembled and deployed to a clinical setting. Upon deployment, the placement of the Pin Housing  210  ensures that the aligned position of the Optics Housing  110  will be maintained. A similar procedure may be used for positioning of the Detector  115 . For example,  FIG. 3  shows an example of how Screws  305  can be used mounting the Detector  115  on the Base Plate  125 , according to some embodiments. The general methodology illustrated in  FIGS. 2 and 3  can be applied to mount additional photometers, as necessary. 
       FIG. 4  shows installation of an Optics Housing  410  on the external ring of Incubation Ring Assembly  404 , according to some embodiments. This example, a single Trough  415  is shown for clarity; however additional troughs may be included internal to the Trough  415  in other embodiments. Furthermore, in contrast to the Incubation Ring Assembly  404 , in the example of  FIG. 4 , the Apertures  420  are circular and a Circular Seal  425  is used when coupling the Optics Housing  410  to the Trough  415 . This coupling is secured using Washer  430  and Nut  435 , with the latter screwing on to threads on the Horizontal Channel  410 A of the Optics Housing  410 .  FIG. 5  shows an overhead view of the fully mounted Optics Housing  410 , with the Nut  435  fully tightened. 
       FIG. 6  shows an overhead view of an Optics Housing  605  and a Detector  610  positioned on the external ring of Incubation Ring Assembly  615 , according to some embodiments. In this example, it is assumed that there is a specific distance (denoted by markers  620 ) that must be maintained between the Optics Housing  605  and the Detector  610 . To support this distance, the Incubation Ring Assembly  615  narrows locally around the Optics Housing  605 , thereby allowing the Optics Housing  605  to be positioned closer to the center of the ring. 
       FIGS. 7A-10B  show example configurations for coupling photometers to a dual incubation ring assembly. In these examples, LED light sources are used. As is generally understood in the art, LED lights allow for longer life versus conventional halogen lamps which, in turn, results in less overall maintenance for the system. In  FIG. 7A , two Detectors  705 A,  705 B are mounted co-planar with the Incubation Ring Assembly  720  on a Base Plate  725 . Single LED Light Source  710  is used to provide light to the optics housings in the Incubation Ring Assembly  720 . The use of a single light source may be preferable, for example, as a means of cost reduction of the overall system. A Bifurcated Fiber Bundle  715  splits the light so that it can be delivered to each individual optics housing.  FIG. 7B  shows an alternate implementation of the configuration presented in  FIG. 7A . In the example of  FIG. 7B , the Single LED Light Source  710  is installed above the Base Plate  725 . The use of a fiber cable with the Bifurcated Fiber Bundle  715  allows installation of the Light Source  710  in either configuration, depending on factors such as ease of access for service. 
       FIG. 8A  provides a similar configuration, with the Detectors  805 A,  805 B mounted co-planar with the Incubation Ring Assembly  820  on Base Plate  825 . However, in contrast to  FIG. 7 , in  FIG. 8  there are two LED Light Sources  810 A and  810 B connected by separate Fiber Optic Cables  815 A,  815 B.  FIG. 8B  shows an alternate version of this configuration where the LED Light Sources  810 A and  810 B are mounted above the Base Plate  825 . 
       FIGS. 9A, 9B, 10A, and 10B  show configurations where the detectors are mounted below the incubation ring assembly.  FIG. 9A  is similar to  FIG. 7A  in that a Light Source  910  delivers light to optics housings in an Incubation Ring Assembly  920  mounted on a Base Plate  925  via a Bifurcated Fiber Bundle  915 . However, in contrast to  FIG. 7A , Optic Cables  925 A,  925 B are used to relay the captured light below the Incubation Ring Assembly  920  to Detectors  905 A and  905 B, respectively.  FIG. 9B  shows an alternate configuration where the Light Source  910  is mounted above the Base Plate  925  while the Detectors  905 A and  905 B are again located above the Base Plate  925 . 
       FIG. 10A  utilizes symmetrical dual LED Light Sources  1010 A,  1010 B connected by Fiber Optic Cables  1015 A,  1015 B to the optics housing in the Incubation Ring Assembly  1020  mounted on Base Plate  1030 . As with the example presented in  FIG. 9A , the configuration shown in  FIG. 10A  utilizes a second set of Fiber Optic Cables  1025 A,  1025 B to relay the light to Detectors  1005 A,  1005 B below the Incubation Ring Assembly  1020 .  FIG. 10B  shows an alternate configuration where the LED Light Sources  1010 A,  1010 B are mounted above the Base Plate  1030 . 
     The embodiments of the present disclosure may be implemented with a combination of hardware and software. In addition, functionality employed by the embodiments of the present disclosure may be included in an article of manufacture (e.g., one or more computer program products) having, for example, computer-readable, non-transitory media. The media has embodied therein, for instance, computer readable program code for providing and facilitating the mechanisms of the embodiments of the present disclosure. The article of manufacture can be included as part of a computer system or sold separately. 
     The functions and process steps herein may be performed automatically, or wholly, or partially in response to user command. An activity (including a step) performed automatically is performed in response to one or more executable instructions or device operations without user direct initiation of the activity. 
     The systems illustrated in the figures are not exclusive. Other systems may be derived in accordance with the principles of the invention to accomplish the same objectives. Although this invention has been described with reference to particular embodiments, it is to be understood that the embodiments and variations shown and described herein are for illustration purposes only. Modifications to the current design may be implemented by those skilled in the art, without departing from the scope of the invention. As described herein, the various systems, subsystems, agents, managers, and processes can be implemented using hardware components, software components, and/or combinations thereof. No claim element herein is to be construed under the provisions of 35 U.S.C. 112(f), unless the element is expressly recited using the phrase “means for.”