High density bottle roller for storage, agitation and reading of blood culture bottles and method of storage

Abstract

An apparatus for storing and monitoring blood culture bottles. The apparatus has a movable rack configured as a carousel having a plurality of receptacles therein for receiving blood culture bottles. The carousel is disposed in a housing. The housing includes a heater and a blower for incubating the blood culture bottles at an elevated temperature. Optionally, the apparatus has a plurality of carousels, each having a plurality of receptacles for receiving blood culture bottles.

Description

[0001] Cross-references to related applications This application claims the benefit of priority to U.S. Provisional Application No. 62 / 883,796, filed August 7, 2019, which is incorporated herein by reference. Technical Field

[0002] This invention relates to a non-invasive device for detecting bioactivity in samples such as blood, wherein a plurality of samples, along with culture media, are introduced into a large number of sealable containers and exposed to conditions that allow various metabolic, physical, and chemical changes to occur in the presence of microorganisms in the samples. These changes are then monitored using colorimetric or fluorescent chemical sensors located at the inner bottom of each blood culture bottle as the bottles are rotated in a rotating drum. After monitoring is complete, the device performs “automatic unloading” and sorting of final negative and final positive bottles. Background Technology

[0003] The presence of bioactive agents, such as bacteria, in a patient's bodily fluids (especially blood) is generally determined using blood culture bottles. A small amount of blood is injected through a sealed rubber septum into a sterile bottle containing culture medium, and the bottle is then incubated at approximately 35°C while monitoring for microbial growth.

[0004] Since determining whether a patient has a bacterial infection is of paramount importance, hospitals and laboratories have automated equipment capable of processing many blood culture bottles simultaneously. An example of such equipment is the BD BACTEC, manufactured and sold by Becton, Dickinson and Co. TM The prior art blood culture device is described in U.S. Patent No. 5,817,508 to Berndt et al., which is incorporated herein by reference. Further descriptions of the blood culture device are provided in U.S. Patent Nos. 5,516,692 (“Compact Blood Culture Apparatus”) and 5,498,543 (“Sub-Compact Blood Culture Apparatus”), which are also incorporated herein by reference.

[0005] Referring to Figure 1, a mixture 22 of culture medium and blood sample is introduced into a sealable glass vial 1, which includes an optical chemiluminescence sensor 20 on its inner bottom surface 21. The optical chemiluminescence sensor 20 emits different amounts of light depending on the amount of gas in the vial 1. For example, the gas being detected by the optical sensor 20 can be carbon dioxide, oxygen, or any gas that increases or decreases depending on the presence or absence of microbial growth in the vial 1.

[0006] As illustrated in Figures 1 and 2, multiple such bottles 1 are radially arranged on a rotating bell-shaped roller 2 within the incubator 5, with the bottoms of the bottles 1 oriented towards the roller axis 28 and the necks 23 of the bottles 1 oriented outwards. The bell-shaped roller 2 is hollow and supported by a shaft 24, which is rotatably supported at one end by two large ball bearings 3 and 4, which are mounted to a first side 51 of the instrument's main frame 50. To read information from each optical chemical sensing device 20 within the bottles 1, a linear array of sensor stations 12 is mounted within the rotating bell-shaped roller 2 to a second side 52 of the instrument's main frame 50. The spacing within the bell-shaped roller 2 is such that, during the rotation of the roller 2, each bottle 1 passes by its corresponding sensor station 15 in the array 12. Each sensor station 15 in the linear array of sensor stations 12 includes an excitation light source 11 and a collecting end of an optical fiber 14.

[0007] The axis 28 of the bell-shaped roller 2 is horizontally oriented and parallel to the door 13 located on the front of the incubator 5, as shown in Figure 2. This horizontal orientation of axis 28 provides maximum agitation of the liquid culture medium and sample mixture 22 within each bottle 1 with the gas. During loading or unloading operations, the door 13 is opened, allowing approximately one-third of all bottles 1 to be loaded or unloaded simultaneously. The roller 2 is then rotated until the next third of bottles 1 becomes retrievable. All bottles 1 are retrievable in these three steps.

[0008] Alternatively, the axis 28 of the bell-shaped drum 2 is vertically oriented with a slight inclination of about 20 degrees away from the door 13. By adjusting the inclination angle, the degree of agitation can be modified (if necessary) to maintain optimal growth conditions.

[0009] In operation, the bell-shaped roller 2 is rotated by a motor 6 and a belt 7. A circular component 8 and a sensor 9 form an angle encoder, which provides information about which row of bottle 1 is passing through the sensor station array 12. Preferably, the motor 6 is a stepper motor, allowing the roller 2 to rotate in continuous mode or to stop at the appropriate angle in steady-state mode for reading from the sensing device 20 within bottle 1. The entire system is controlled by a control system 10 located inside the rotating roller 2. The outputs of all the optical fibers 14 of the linear array of sensor stations 12 are fed to a common photodetector (not shown) in the control system 10, so that only one excitation light source 11 needs to be turned on at a time. Thus, the control system "knows" from which sensor station 15 is collecting sensor light, and therefore knows from which bottle 1 is collecting sensor light.

[0010] The apparatus shown in Figures 1 and 2 comprises ten segments of blood culture bottles 1, each segment containing thirty-six vials 1. Therefore, the total capacity is 360 vials. The arrangement of the vials 1 on the rollers 2 allows for a relatively high packing density, but improvements in density are still sought. Summary of the Invention

[0011] This document describes an apparatus for storing and monitoring blood culture flasks. The apparatus has a movable support configured as a roller, which has multiple containers for receiving blood culture flasks. The roller is housed within a housing. The housing includes a heater and a blower for incubating the blood culture flasks at elevated temperatures. Optionally, the apparatus has multiple rollers, each roller having multiple containers for receiving blood culture flasks.

[0012] Blood culture flasks typically have a bottom portion and a neck portion, with the bottom portion being the larger volume of the flask and the neck portion being the narrower top portion. The roller container can be configured to receive the blood culture flask with the bottom facing inwards (bottom-inwards) or the neck facing inwards (neck-inwards). In the bottom-inwards configuration, the container is typically angled downwards, holding the culture flask at a 20° angle from the horizontal upwards. However, the culture flask can be held horizontally (i.e., the neck portion is not angled upwards or downwards relative to the bottom portion), and accurate measurements of the contents of the blood culture flask can be obtained to determine whether the contents are positive for microbial growth. To achieve high flask density, the roller is configured to rotate about an axis, with a circular roller support coaxially positioned with respect to the axis of rotation. If the culture flask is placed in the roller with its bottom side facing inwards, the electronics for monitoring the blood culture flask are housed inside the roller. If the flask is placed in the roller neck-inwards, some of the measuring electronics are located on the outside of the roller.

[0013] The roller is formed in a modular manner. The roller has multiple rows and multiple columns of containers. In one configuration, the rows of containers are formed by obtaining molded articles as upper and lower portions of the rows. The molded articles are assembled to form one row of the roller, and multiple rows are assembled together to form the roller. Optionally, the containers are vertically aligned in the assembled roller. Optionally, the containers are staggered in the assembled roller, which provides a greater bottle density in the roller.

[0014] The roller has both an outer perimeter and an inner perimeter. A container holds the culture flask within it, and the container extends from a first perimeter to a second perimeter. The containers are evenly distributed in rows traveling along the perimeter of the roller.

[0015] In embodiments where the drum container receives the bottles inwards at the neck, the container includes a mechanism for holding the bottles within the container. This mechanism can be a spring clip, cap clip, plate spring, or stop. Such a mechanism allows the culture bottles to be securely held within the drum during drum operation.

[0016] This document describes a device for storing and monitoring blood culture bottles. The device has a housing containing a roller. The roller has an outer periphery and an inner periphery. The outer periphery has a diameter greater than that of the inner periphery. The roller has multiple receptacles having a proximal end at the outer periphery and a distal end at the inner periphery, each receptacle configured to receive a blood culture bottle. The blood culture bottle has a bottom portion and a neck portion, wherein the bottle can be received by a receptacle such that the bottom portion is received at the distal end of the receptacle or the neck portion is received at the distal end of the receptacle.

[0017] The drum's periphery is arranged around its axis of rotation. Multiple containers are arranged in an array within the drum, the array having containers positioned both vertically and horizontally. The device also includes sensors and detectors for interrogating blood culture bottles to determine whether the blood culture bottles are positive or negative for microbial growth. The drum defines an internal space within its inner periphery, wherein at least a portion of the drum electronics communicating with the sensors and detectors used for interrogating the blood culture bottles is disposed within the inner periphery of the drum.

[0018] Optionally, each of the plurality of containers has a corresponding elastomeric insert for receiving a culture flask. Optionally, each of the plurality of containers receives the neck portion of the culture flask at its distal end, and each container includes a flask stop and a helical spring spaced apart from the flask stop. The helical spring is biased to allow a cap disposed on the neck portion of the flask to pass through the helical spring and advance to abut against the flask stop, whereby the helical spring releases tension and secures the culture flask in the container.

[0019] Optionally, multiple containers each receive the neck portion of the culture flask at its distal end, and each container includes a flask stop and an O-ring spaced apart from the flask stop. The O-ring is sufficiently elastic to allow a cap positioned on the neck portion of the flask to pass through the O-ring and advance to abut against the flask stop. The O-ring then releases tension and secures the culture flask in the container.

[0020] Optionally, multiple containers each receive the neck portion of the culture flask at its distal end, and each container has a flask stop and a ball plug spaced apart from the flask stop. The ball plug is biased to allow a cap positioned on the neck portion of the flask to pass through the ball plug and advance to abut against the flask stop. The ball plug then releases tension and secures the culture flask in the container.

[0021] Optionally, multiple containers each receive the neck portion of a culture flask at its distal end, and each container includes a flask stop and segmented retaining portions spaced apart from the flask stop. The segmented retaining portions are biased to allow a cap disposed on the neck portion of the flask to enter the segmented retaining portions and advance to abut against the flask stop. The segmented retaining portions release tension and secure the culture flask within the container.

[0022] Alternatively, the segmented retaining portions are forced together by a helical coil spring, or the segmented retaining portions are elastic segments.

[0023] Optionally, each of the plurality of containers receives a neck portion at its distal end, and each container has a bottle stop and a plurality of resilient wings extending from the bottle stop. The wings are biased to allow a cap disposed on the neck portion of the bottle to pass through the flange portion of the wing and advance to abut against the bottle stop. The wings release tension and the flange portion secures the culture bottle in the container. Optionally, each container with resilient wings has a ball stop. The bottle stop has a notch. As the culture bottle is advanced into the bottle stop, the bottle stop is further advanced into the container until the ball stop aligns with the notch, thereby securing the bottle stop in the container.

[0024] Optionally, the multiple containers have notches and the bottle stop has a ball plug. As the culture flask is pushed into the bottle stop, the bottle stop is further pushed into the container until the ball plug aligns with the notch, which secures the bottle stop in the container.

[0025] Optionally, multiple containers have tray portions on which culture flasks are placed. The tray portions have lugs for securing the bottoms of the culture flasks within the tray. The containers also have stop portions. The stop portions position the culture flasks in a predetermined fixed position within the containers. The stop portions can be one of the following: leaf springs, deformable materials, and / or pivot arms that pivot in response to the culture flasks being pushed into the containers, thereby securing the culture flasks within the containers. The stop portions can be made of an elastic material selected from elastomeric flexible tubes, elastomeric materials, or foam materials.

[0026] Optionally, the tray portion of the container forms a light tube that transmits light signals from indicator LEDs disposed within the inner periphery of the roller for visibility from the outside of the roller. The bottle stop can also be a keyhole-shaped element. Optionally, both the outer and inner peripheries of the roller are circular.

[0027] This article describes a method for controlling an incubator for multiple blood culture flasks. In this method, an operator inputs a predetermined sector of the blood culture roller via a control interface. The blood culture roller is a support defining an inner periphery and an outer periphery of a generally circular shape. The blood culture roller is rotatable. A door to the housing of the blood culture roller is opened by the operator and the roller is typically stopped by reducing the power of the motor used to rotate the roller, making the predetermined sector accessible through the open door of the housing. The blood culture roller has multiple receptacles, each of which is adapted to receive and hold blood culture flasks. Each of the multiple receptacles has an indicator at its proximal end. This indicator provides an indication of whether the culture flask in the receptacle is positive or negative for microbial growth. Blood culture flasks are inserted into empty receptacles of the multiple receptacles, removed from receptacles of the multiple receptacles, or removed from one receptacle of the multiple receptacles and then inserted into the position of another blood culture flask. Blood culture flasks are removed based on their indicated status.

[0028] Optionally, each container has a light tube extending from the proximal end of the container to the distal end. Optionally, the control interface communicates with an encoder, enabling the control interface to track the placement of each blood culture bottle in the holder. Optionally, the incubator further includes a reader station, wherein the reader station determines the state of the blood culture bottle as the bottle roller rotates past the container carrying the blood culture bottle. Optionally, an indicator LED is positioned at the distal end of at least a portion of the container in the bottle roller. As described elsewhere herein, the culture bottle is received in each of the plurality of containers with the neck facing inward or the bottom facing inward. Thus, the container is configured to receive the culture bottle with the neck facing inward or the bottom facing inward. Attached Figure Description

[0029] Figure 1 shows a front view of the interior of a prior art blood culture device for the detection of microorganisms; Figure 2 shows a side view of the interior of a prior art blood culture device; Figure 3A and Figure 3B The illustration shows a perspective view of the blood culture device housing used for the modules described herein; Figure 4 This is a top view of an incubation and measurement module according to an embodiment of the present invention; Figures 5A-5B It is the cross-section of the incubation and measurement module roller; Figures 6A-6B An example of an actuator used for the incubation and measurement module is illustrated; Figure 7 This is a schematic diagram of a culture flask placed bottom-to-inside within a high-density roller as described herein; Figure 8It is a cross-section of one embodiment of the roller described herein having a culture flask placed bottom-inward; Figure 9 The illustration shows three stacked rollers; Figure 10 The illustration shows different roller designs for culture flasks with the neck facing inwards; Figure 11 yes Figure 10 The cross-section of the inward-facing neck of the roller shown in the figure; Figure 12 yes Figure 11 The stacking of rollers as described in the text; Figure 13 The illustration shows an exploded view of the bottle roller and a stacked bottle roller of the present invention; Figure 14 The illustration shows another embodiment of the bottle roller of the present invention and an exploded view of a stacked bottle roller configuration; Figures 15A-15B It uses a "neck-inward" roller configuration assembled with vertical sections; Figures 16A-16B This is an alternative embodiment of a "neck-inward" roller configuration assembled from vertical sections; Figures 17A-17G The illustration shows a bottle holding mechanism for a "neck-in" roller configuration; Figures 18A-18C The illustration shows a bottle holding mechanism according to an alternative embodiment; Figures 19A-19Q The illustrations depict bottle-holding mechanisms according to different embodiments; Figures 20A-20H It is an alternative bottle-holding mechanism integrated with a light tube; Figure 21 yes Figures 20A-20C Detailed view; Figure 22 The illustration shows an unsealed bottle in a roller. Figure 23 The diagram illustrates the alternative roller configuration; Figure 24 The figure illustrates the BCP response curves obtained from embodiments of the device described herein; Figure 25 The illustration shows an example of a ring bearing; Figure 26 Another bottle-holding mechanism is illustrated; Figure 27 The illustration shows a culture flask cap that carries information about the status of the culture flask for use by the operator or user. Figures 28A-28B The diagram illustrates the process of... Figures 20A-20C The roller formed by the receiving seat shown in the diagram; and Figure 29 The diagram illustrates the process of... Figures 17A-17C The diagram shows a row of rollers formed by the housing. Detailed Implementation

[0030] This document describes a blood culture device configured as an incubation and measurement module, which can optionally be integrated with a larger end-to-end solution for processing biological samples to determine whether such samples are contaminated with microorganisms or infected by microorganisms. The module described herein can be placed in, for example, Figure 3A and Figure 3B The cabinet shown in the diagram. Cabinet 200 can provide power to the module, a controlled thermal environment for the module, and a communication channel for the module. Figure 3A The illustration shows a cabinet 200 with two three-door panels 201, each providing access to three bottle rollers on each side of a central panel 202. The central panel 202 has a touchscreen 203 for data input and user control. The central panel 202 also has a central station 204 for culture bottle input / output. Figure 3B The illustration shows a cabinet with only one three-door panel 201.

[0031] The module features a high-density bottle roller. As used herein, "high density" describes a roller configuration that allows culture flasks to be placed closer together to allow a greater number of flasks to be assembled within the roller compared to existing technologies. The module is configured to align the flasks with a limited number of reader stations. That is, the number of reader stations is less than the number of bottle seats in the roller. Optionally, the roller is operated by a direct-drive motor capable of causing acceleration and deceleration of the roller movement (i.e., rocking movement, intermittent rotation, etc.). A heater and blower are provided within the roller housing. The heater and blower circulate warm air around the roller. Optionally, the heater and blower will be configured to maintain the temperature of the contents of all the culture flasks in the roller within a predetermined narrow range of a specific target temperature. The predetermined narrow range is ±1.5°C of the target temperature. The specific target temperature is in the range of 30°C to 40°C. Optionally, the target temperature is 35°C. Greater temperature uniformity will allow for an increase in the set point due to a lower risk of "overheating" the sample. Greater temperature uniformity at higher temperatures will therefore allow for faster detection times. The motor allows the rollers to be positioned so that users or automated equipment can pick up and place any bottle carried by the rollers. When the sample in the bottle is determined to be positive for microbial growth, a workflow is activated to retrieve the culture bottle from the module. The module is configured to facilitate this workflow.

[0032] The module is configured with LEDs and light tubes to indicate positive culture flasks to the user. (Reference) Figure 4The illustration shows a top view of an optional configuration of the module described herein. Module 210 has a housing 224, a blower and heater 225 for keeping culture flasks 230 warm, and a roller 240 with a holder for receiving culture flasks. Measuring electronics 250 and culture flask detection / indicator electronics 260 are positioned inside the roller. A drive motor 270 is provided to rotate the roller 240. The housing 224 of the roller 240 has six panels 221 defining six roller sectors (222A-222F). As illustrated, approximately one-sixth of the roller contents (assuming the roller is full) are available for loading and unloading at any given time, because the span of a sector is approximately the same as the span of an opening in the housing through which flasks are added to or removed from the roller 240. Figure 5A yes Figure 4 A side sectional view of the roller. Culture flasks 230 are positioned neck-inward within a reservoir 220 in the roller 240. Motor 270 is a direct-drive motor providing high torque, virtually no hysteresis, low noise, reliability, and simplicity.

[0033] Figure 5B It is the cross-section of the temperature and measurement module roller with a stepper motor and gearbox. Alternatively, if the correct dimensions and spacing between the internal gearbox bearings cannot be achieved within the limited space constraints within the roller, an additional bearing assembly can be included toward the bottom of the roller ring.

[0034] like Figure 5A As illustrated, the motor drives the roller to rotate axially. The bearings within the gearbox of the motor 270 provide both axial alignment of the roller 240 and the necessary thrust load support required to propel the roller carrying a large number of bottles 230. Alternatively, if the correct dimensions and spacing between the internal gearbox bearings cannot be achieved within the limited space provided inside the roller periphery, additional bearing assemblies can be included towards the bottom of the roller ring. Mechanisms that enable the roller 240 to rotate about its axis are well known to those skilled in the art and are not described in detail herein. This structure and bearing configuration can be adapted to other roller configurations (e.g., rollers that receive culture bottles with the neck facing outwards rather than inwards; rollers with the container angled upwards, etc.). Optionally, the measuring electronics, status indicators, and bottle detection electronics are all supported by a single axle 285.

[0035] exist Figure 5A In this context, rotary actuators, hollow rotary actuators, or stepper motors with gearboxes are used to combine bearing and motor functions into a single component. An example of such a suitable motor actuator is shown in Figure 6. Figure 6AIt is a hollow rotary actuator 294 with a motor 296 that drives a pinion 297. The rotation of the pinion 297 causes the roller gear 298 to rotate the output table 239, thereby causing the roller 240 (not shown) to rotate. Figure 6B This is a rotary actuator 299 that directly causes the rotation of roller 240 (not shown). Other examples of suitable motors with gearboxes are considered. Such motors can be directly attached to a gearbox (typically at the factory). This gearbox can reduce the motor speed while increasing the torque at the output shaft. The output shaft can be mechanically attached to a circular spacer having an attachment point suitable for interfacing with the roller.

[0036] Figure 5B The illustration shows a culture flask 230 positioned at a 20° angle above the horizontal within a roller 240. Technicians should note that the sensor (not shown) within the culture flask must be completely covered by the substrate during readings. Other angles have been considered to meet these guidelines, but the flask angle must also accommodate high-density designs.

[0037] One embodiment may include a top bearing 290 adjacent to the top of the roller 240 and a second bearing facing the bottom of the roller 240. Optionally, the first (top) bearing is a thrust ball bearing, and the second (bottom) bearing is a spherical bearing to accommodate any non-coaxial relationship between the first and second bearings. These structures and bearing configurations can be adapted to other roller configurations (e.g., rollers that receive culture flasks with the neck facing inward rather than outward). Motor 270 is a direct-drive motor that provides high torque, virtually no hysteresis, low noise, reliability, and simplicity. Figure 5B As illustrated, a single axle 285' supports the bottle roller 240 and the drive motor 270. Two bearings 290 between the axle 285 and the roller 240 are similar to the two bearings supporting a rotor in prior art instruments. The distance between the two bearings can be increased to minimize movement of the inner surface of the bottle roller relative to the axle. These structures and bearing configurations can be adapted to other roller configurations (e.g., rollers that receive culture bottles with the neck facing inwards rather than outwards). Optionally, measuring electronics, status indicators, and bottle detection electronics are all supported by the single axle 285.

[0038] An alternative embodiment deploys a top-mounted ring bearing, which is smaller than the ring bearing used to guide the rotation of the drum in existing systems. Figure 25 The diagram shows a 700 ring bearing. Figure 23 The diagram illustrates a bottom-mounted ring bearing 600. Those skilled in the art can replace bearing 290 with a ring bearing that supports the roller from the top and is attached to the module housing 224.

[0039] refer to Figure 7The bottle roller 240 is a structure that maintains the tightly packed arrangement of the culture flasks 230 with their necks facing outwards. The culture flasks 230 are arranged in staggered layers 241, 242 with their necks pointing outwards from the roller 240. Figure 8 They are arranged in a manner that allows for tight packing. Figure 9 It is configured for Figure 3A and Figure 3B The frame of the three-door cabinet shown in the diagram. Figure 8 The diagram shows a perspective view of the staggered rollers. The staggered culture flask placement also creates controls above each culture flask for marking the culture flask container 220 and detecting the light tube indicator 295. Figure 5B The output of each bottle holder 220 will have a number indicating its horizontal position in the rollers and a status indicator to guide the user during manual workflow.

[0040] refer to Figure 10 Bottles 230 (facing inward) in roller 240 are placed into one of six sectors (222A-222F) in module 210. Sectors are defined by vertical panels extending outward from roller 240. The span between adjacent panels is approximately equal to the span of the door leading to housing 224, completely isolating the user from the module's interior when the user is handling the section of the culture bottle. Module 210 also includes a blower and heater 225 for keeping the bottles 230 warm. Culture bottle detection electronics 260 are located inside roller 240 (223). Measuring electronics 250 are located outside roller. A drive motor 270 is provided to rotate roller 240.

[0041] refer to Figure 11 The bottle roller 240 has a container 220 for receiving culture flasks arranged in a layered manner with their necks facing inward, as described above. The container 220 has a light tube formed in a bottom portion of the container, which also defines a bottom edge of the container. These features are described elsewhere herein. Figure 12 In the example shown in Figure 3, a bottle roller was removed from the three-door cabinet 200. Figure 11 As shown, each layer 231 has twenty-four receptacles 220, which will receive twenty-four bottles 230. Each roller 240 has eight layers 231 and three rollers 240, resulting in a bottle capacity of approximately 576. Optionally, the module has receptacles that receive bottles with the neck facing outwards. In one embodiment, the rollers will have thirty receptacles per layer, eight layers per roller, and three rollers, resulting in a bottle capacity of approximately 720.

[0042] Figure 13The illustration shows a roller formed by injection-molded layers 300A and 300B. When assembled together, the injection-molded layers together form a single layer 310 of roller 240. Optionally, the injection-molded layers are molded to have discrete holding features, cavities, or other features provided to facilitate the reception, holding, and release of culture flasks in a container. Molding a container with such features reduces the number of discrete parts and simplifies the manufacturing process. Instead... Figure 13 The circular geometry of the roller, due to manufacturing reasons or user aesthetic preferences, can result in a cross-section with multiple internal and external faces. Figure 15A The diagram shows multiple faceted rollers.

[0043] Figure 14 The illustration shows a roller formed by injection-molded layers 320A and 320B. When assembled together, the injection-molded layers together form a single layer 330 of roller 240. Figure 14 In one embodiment, when combined, molded layers 320A and 320B form a honeycomb stack of the container 220, providing approximately 20 percent higher bottle density within the roller 240. Optionally, the injection-molded layers are molded to have discrete holding features, cavities, or other features provided to facilitate the reception, holding, and release of culture flasks within the container. Molding a container with such features reduces the number of discrete parts and simplifies the manufacturing process.

[0044] The rollers can also be assembled in vertical sections. (Reference) Figure 15A Bottle roller 240 (similar in appearance) Figure 13 The rollers shown in the diagram are assembled in a manner that forms the first vertical section 248 of the bottle container. The first vertical section 248 forms linear rows and columns of the bottle container 220, in which the bottle 230 is inserted inward with its neck facing inward. (Reference) Figure 15B Roller 240 (similar in appearance) Figure 14 The rollers (illustrated in the middle) are assembled from second vertical sections 249. The second vertical sections 249 form a linear column of the bottle container 220, but the rows are staggered to provide a higher capacity roller 240. The vertical sections can be formed by injection molding. The vertical sections are interlocked or attached to a central ring. Optionally, the injection-molded layer is molded to have discrete holding features, cavities, or other features provided to facilitate the reception, holding, and release of culture bottles in the container. Molding a container with such features reduces the number of discrete parts and simplifies the manufacturing process.

[0045] In a neck-inward roller configuration, a mechanism is required in the culture flask holder to hold and release the culture flask. Figure 16A and Figure 16B The diagram illustrates vertical segment 805 instead of... Figure 13The roller 800 is assembled in a horizontal segmented manner as shown in the diagram. As mentioned above, the vertical segments 805 have at least one bottle holder 810 in each row. However, as... Figure 16A and 16B As illustrated, the vertical segment 805 may have multiple bottle holders 810 in each row. The bottle holders 810 are configured to receive bottles 830 having a narrow neck portion 835 and a wider bottle portion 840. Thus, as illustrated, the bottle holder 810 has an outer portion 845 and a narrower inner portion 850, the outer portion 845 having a diameter sufficient to receive the wider bottle portion 840, and the narrower inner portion 850 having a diameter sufficient to receive the narrow neck portion 835. Many bottle holding mechanisms considered herein exist, as described elsewhere herein. Figure 16A and 16B The illustration shows a bottle holder 810 having an elastomeric insert bushing 855 within it. The elastomeric insert bushing 855 has a first flange 860 that holds it within the bottle holder 810. The elastomeric insert bushing 855 has a second flange 865 positioned in a narrower inner portion 850 such that when a bottle 830 is inserted into the holder 810, the second flange 865 is fitted into the holder between the cap 870 placed on the bottle 830 and the narrow neck portion 835 of the bottle 830. The second flange 865 holds the bottle 830 within the holder 810, but the force with which the second flange 865 holds the bottle 830 within the holder 810 can be easily overcome when the bottle 830 is to be removed from the bottle holder 810 of the roller 800.

[0046] refer to Figures 17A-17C A beveled spring 400 is located at the distal end 415 of the flask holder 220 and is sized to clamp the corrugated cap 410 of the culture flask 230. When the user pushes the culture flask 230 into the flask holder 220, this pushes the corrugated cap 410 of the culture flask past the beveled spring 400, which holds the culture flask 230 in the flask holder 220. The bottom 416 of the culture flask 230 extends from the proximal end 420 of the flask holder 220, allowing the bottom 416 of the culture flask to be clamped by the user or a robot for removal. Figures 17A-17C These are different views of the same mechanism. All are within the same cross-section. Figure 17A It is the entire bottle container 220 in which the culture flask 230 is located. Figure 17B This is a detailed plan view of the distal end 415 of the bottle holder 220, and Figure 17C This is a detailed perspective view of the distal end 415 of the reservoir 220. Figure 29 The diagram shows the composition of... Figures 17A-17C The diagram shows a row of rollers formed by a container. Rollers formed by such containers are faceted rather than perfectly circular.

[0047] Alternatively, the pleated ring cap 410 is a deformable metal (e.g., aluminum) cap with a diaphragm in the center. (Reference) Figure 27 The top view of the cap shows a metal pleated seal periphery 411 with metal pleats 412, the metal pleats 412 being slightly recessed from the metal pleated periphery 411. The pleated ring cap 410 may carry a mark 413 providing information to the operator or user regarding the status of the culture bottle on which the cap is placed (i.e., whether it is positive or negative for microbial growth). To mark the pleated cap with the status indication, the blood culture bottle is pressed into a cavity at its bottom with a raised symbol (a plus sign in the illustrated embodiment) to indicate that the system has determined the culture bottle to be positive for microbial growth. As illustrated, the mark 413 is aligned with the flat metal portion of the pleated seal. When the cap is pressed onto the raised symbol, the indentation of the mark 413 is left on the pleated seal.

[0048] Figure 29 The illustration shows that it has Figures 17A-17C The diagram shows the layers of roller 240 in the receiver. Due to the way the receivers are assembled... Figure 29 The rollers illustrated have a segmented outer and inner perimeter. Receptacles with coil springs can be closely spaced vertically. Forming the rollers with these receptacles can provide significant height savings (e.g., approximately 50 mm). In embodiments where multiple rollers are placed in a single cabinet, the cabinet size can be more compact and easier for the user to access. The reduced roller height also allows more electronics to be placed in the top and bottom sections of the temperature and measurement cabinet. Figure 29 The illustration shows one row of the reservoir 220. As described herein, the rollers are assembled from multiple rows that are connected together to form roller 240.

[0049] Because the bottom of the culture flask is 416 ( Figure 17A The culture flask extends from the container 220 so that the culture flask can obscure the station indicator on the proximal end 463 of the container 220 when viewed from or below the container. To address this potential problem, a station indicator light tube (not shown) extends from the distal end 415 of the container to the proximal end 463 of the container. Alternatively, the culture flask container 220 can be sized such that the culture flask is fully fitted therein, but the proximal end of the container near the bottom of the culture flask is flared or serrated to provide gripping and placement for the user or robot.

[0050] Another consideration is the critical nature of the bottle's base relative to the position of its measuring optics and electronics. The inclined coil spring must pull the bottle against a rigid stop so that the bottle base does not move in any direction when the bottle rollers are rotating or when the bottle is touched by the user during a manual workflow.

[0051] Figures 17D-17FThe illustration shows an alternative retaining mechanism with a ball stopper 474 disposed in a narrower portion 850 of a bottle container 220. (Reference) Figure 17D The stopper 474 has a ball 471 that is outwardly biased by a spring arm 476 and extends into a narrower portion 850 of the bottle container 220. Figure 17D The diagram shows the ball stopper 474 from the distal end of the bottle container 220, which is the far end of the narrower portion 850 of the bottle container 220. (Reference) Figure 17E When the culture flask 230 is pushed into the narrower portion 850 of the flask container 220, the ball 471 is seen extending outward into the narrower portion 850 of the flask container 220. (Reference) Figure 17F As the culture flask 230 is further advanced, the corrugated cap 410 of the culture flask 230 pushes the ball 471 back into the channel 472 formed in the narrower portion 850 of the flask container 220. After the corrugated cap 410 of the culture flask 230 is advanced over the ball 471 of the ball stopper 470, the biasing force applied to the ball 471 causes the ball 471 to advance into the space 472 formed between the corrugated cap 410 of the culture flask 230 and the narrow neck portion 835 of the culture flask 230. This biasing force holds the culture flask 230 in place in the flask container 220. When the culture flask 230 is removed from the flask container, the biasing force of the ball stopper 474 is overcome, allowing the corrugated cap 410 of the culture flask 230 to pass over the ball stopper 474 and be removed from the flask container 220.

[0052] Figure 17G The illustration shows an alternative container 220, in which an O-ring 461 engages a locking device 462 below the pleated ring cap 410 of a culture flask 230. Conventional O-rings are considered and can be made by, for example, Viton... TM Materials such as silicone resin or other conventional elastomers are well known to those skilled in the art and are not described in detail herein. Figure 17G As illustrated in the diagram, the container 220 receives only a portion of the culture flask 230 and terminates at a proximal end 463 (near the transition from the neck 435 of the culture flask to the bottom portion 416 of the culture flask 230). This allows for easy observation if the culture flask is not properly positioned in the container, as it will tilt from its intended location.

[0053] Figures 18A-18C The illustration shows a variation of the inclined coil spring shown in Figure 17. Figure 18A This is a perspective view of the retaining cap on the bottle. Figure 18B yes Figure 18A A cross-sectional view of the lid. Figure 18C yes Figure 18A Top perspective view of the segmented retaining mechanism. (Reference) Figure 18AThe retaining mechanism 431 has radially translatable features to receive the neck 435 of the bottle 230 and the pleated ring cap 410. Figure 18B Multiple wedge-shaped segments 430A-430C are present. Three wedge-shaped segments 430A-430C are illustrated, but multiple segments of varying numbers are considered. The wedge-shaped segments 430A-430C are positioned in the distal end of the narrower portion 850 of the culture flask container 220 within the drum. A pleated ring cap 410, attached to the neck 435 of the flask 230, enters the flared proximal end 440 of the holding mechanism 431. The proximal end 440 of the holding mechanism 431 is flared to receive the pleated ring cap 410 of the flask. The holding mechanism 431 has a stop flange 432 such that the neck portion 435 can be pushed in only a distance defined by the holding mechanism 431. The holding mechanism has a peripheral spring 433, which allows the wedge-shaped segments 430A-430C to move radially in response to the neck portion being inserted therein, but applies tension to ensure that the pleated ring cap 410 is held firmly in the holding mechanism.

[0054] Figures 19A-19C A variation of the inclined coil spring illustrated in Figure 17 is shown. In this embodiment, the segmented retaining mechanism 450 has clamping sections 460A-460E separated by a space 465. The clamping sections 460A-460E are elastic, and the space 465 allows the clamping sections to expand but applies clamping force to the pleated ring cap 410 and the neck portion 435 inserted therein. Similar to... Figures 18A-18C In one embodiment, the proximal end 470 of the retaining mechanism 450 is flared to receive the pleated ring cap 410 and the neck portion 435. In one example, the resilient clamping segments 460A-460E are made of ABS plastic. Each segment 460A-460E is radially bent to capture the pleated ring cap 410 and the neck portion 435. Although in Figures 19A-19C The diagram shows five sections, but this is for illustration purposes only. Holding mechanisms with different numbers of sections are considered.

[0055] Figures 19D-19Q Other alternative retention mechanisms are illustrated. Figure 19D The illustration shows a slotted cap 451, which has a slot 481 that cooperates with a ball stopper 474 to lock the slotted cap 451 into the bottle container 220. The wing 482 is tensioned and has an action with... Figure 16B The second flange 865 in the diagram closely resembles flange 483. (Reference) Figure 19E As the culture flask 230 is advanced forward within the flask holder 220, the wing 482 is biased outward and receives the narrow neck portion 835 of the culture flask 230. The slot 481 of the grooved cap 451 is not aligned with the ball plug 474 at this time. (Reference) Figure 19FAs the culture flask 230 is further advanced toward the distal end of the container 220, the narrower inner portion 850 of the container 220 gradually decreases, forcing the wings 482 inward, so that the flange 483 fits into the space between the pleated cap 410 and the narrow neck portion 835 of the culture flask 230. Furthermore, the slotted cap 451 is advanced, aligning the slot 481 with the ball 471 of the ball stopper, locking the slotted cap in place within the container. To remove the culture flask, the biasing force of the ball stopper 474 is overcome, allowing the pleated cap 410 to pass over the ball stopper 474, enabling the flask to be removed. Because the wings 482 of the slotted cap 451 are biased outward, the flange 483 is removed from alignment with the culture flask 230 as the culture flask is advanced outward from the container 220.

[0056] Figures 19G-19I The illustration shows a stopper cap 452 with a stopper 474 formed therein. The stopper cap 452 cooperates with slots 487A and 487B in the bottle container 220 to lock the stopper cap 452 into the bottle container 220 when it is in a first unlocked position and a second locked position. The wing 482 is tensioned and has an action with... Figure 16B The second flange 865 in the diagram closely resembles flange 483. (Reference) Figure 19H The cap 452 is in the first unlocked position, and the ball plug 474 is aligned with the slot 487A. As the culture flask 230 is advanced forward in the flask container 220, the wing 482 is biased outward and receives the narrow neck portion 835 of the culture flask 230. The slot 487B of the flask container 220 is not aligned with the ball plug 474 at this time. (Reference) Figure 19F As the culture flask 230 is further advanced toward the distal end of the container 220, the narrower inner portion 850 of the container 220 gradually decreases, forcing the wing 482 inward, so that the flange 483 fits into the space between the pleated ring cap 410 and the narrow neck portion 835 of the culture flask 230. Furthermore, the ball stopper cap 452 is advanced, aligning the slot 481 with the ball 471 of the ball stopper, thereby locking the ball stopper cap 452 in the proper position within the container. To remove the culture flask 230, the biasing force of the ball stopper 474 is overcome, allowing the assembly of the culture flask 230 and the ball stopper cap 452 to advance to a first position, where the flange 483 is again biased outward and releases the culture flask 230. In the first position, the slot 487A of the container 220 is again aligned with the ball stopper 474 of the ball stopper cap 452, thereby retaining the ball stopper cap 452 within the container when the flask is removed from the culture flask container.

[0057] Figure 19J and Figure 19K The diagram shows Figures 19G-19I The diagram illustrates how the bottle holder 220 is assembled into the roller 240. Figure 19JIn this design, the bottle holder 220 has a slot 838 positioned to align with a track 839 in the roller opening, and is advanced into the opening using this alignment until the bottle holder 220 is fully positioned within the opening of the roller 24. (Reference) Figure 19K The bottle holder 220 is then rotated to lock the bottle holder 220 into the roller 240.

[0058] Figures 19L-19Q yes Figures 18A-18C and Figures 19A-19C The alternative bottle holders shown in the diagram. (Reference) Figure 19L The bottle holder 453, configured to be placed in a bottle holder, has wings 841 and a beveled coil spring 842. Other types of spring components (such as elastomer O-rings or clamping springs) are also considered. When the narrow neck portion 835 of the culture flask is advanced into the bottle holder 453, the wings 841 can be forced apart, overcoming the bias of the beveled coil spring 842, and... Figure 19M Illustration. When forced apart, the wing 841 has a groove 491 that travels along the track 492. The bottle holder 453 has a flange 483. When the pleated cap 410 of the culture bottle 230 is pushed past the flange 483, the biasing force of the inclined coil spring 842 forces the wings back together, and the flange is located at the base of the pleated cap 410, thereby securing the culture bottle in the bottle holder, as shown. Figure 19N As illustrated in the diagram. Again, the groove 491 in wing 841 allows wing 841 to travel back along track 492 to its closed position. (Not in...) Figure 19M and 19N The diagram shows a slanted coil spring, causing the wing to... Figure 19M The forced opening position in the middle Figure 19N The movement of the closed position in the middle can be clearly seen.

[0059] Figures 19O-19Q The diagram shows... Figures 19L-19N Bottle retainer 454 is a variant of the bottle retainer described in [reference]. Figure 19O The bottle holder 454, configured to be placed in a bottle container, has wings 841 and a clamping spring 842. When the narrow neck portion 835 of the culture flask is advanced into the bottle holder 454, the wings 841 can be forced apart, overcoming the bias of the clamping spring 842, and... Figure 19P The illustration shows that when forced apart, the wing 841 has a groove 491 that travels along the track 492. The bottle holder 454 has a flange 483. When the pleated cap 410 of the culture bottle is pushed past the flange 483, the biasing force of the clamping spring 842 forces the wings back together, and the flange is located at the base of the pleated cap 410. This secures the culture bottle in the bottle holder, as shown. Figure 19QAs illustrated in the diagram. Again, the groove 491 in wing 841 allows wing 841 to travel back along track 492 to its closed position. (Not in...) Figure 19P The middle illustration shows the clamping spring, which allows the movement of the wing to the forced-open position to be clearly seen.

[0060] Figures 20A-20C An alternative mechanism 500 for holding the flask in the drum is illustrated. Mechanism 500 uses a flat spring 510 to hold the culture flask 230 in the container 220. In this configuration, the bottom 416 of the culture flask is secured in the container by a lug 417. The container 220 has an opening 418 that allows the culture flask 230 to be manually or by being inserted into the retainer 220 and removed from the container 220 by a robot gripper. This allows for the placement and removal of the culture flask 230 secured in the drum container 220. The user or robot pushes the flask into the container 220 until the flat spring 510 presses against the flask and the bottom 416 of the flask falls in front of the lug 417. The flat spring 510 holds the flask against a stop 530. To remove the culture flask 230, the user or robot pushes the culture flask 230 away from the lug 417 to allow the flask 230 to be withdrawn from the container 220. When the culture flask 230 is not secured by the lug 417, the flat spring 510 also pushes the culture flask 230 toward the proximal end 420 of the container 220 to facilitate retrieval.

[0061] refer to Figure 21 The container also has a light tube 515 to divert light from the distal end 525 of the container (i.e., inside the roller 240 in which the container is disposed) from the indicator LED 520. If present, the light tube 515 cradles the bottle 230 and extends past the proximal end 420 of the container (i.e., the outer surface of the roller 240). A flat spring 510 with a free end 535 presses against the upper shoulder 530 of the culture bottle 230 to hold the culture bottle 230 against the lug 417. The container 220 is adjacent to the bottle detector 536 at its distal end 525. The distal end of the bottle 230 in the container 220 is detected by the bottle detector 536. The bottle detector 536 is carried by a fixed detector plate 540. Figure 20B and Figure 20C As shown in the diagram, the spring is enmolded into the housing 220.

[0062] The module includes measuring electronics 545 for each layer of bottles 230 in each roller 240. For example... Figure 20A As shown in the diagram, the measuring electronics 545 is positioned outside the roller 240 in the front right corner of module 210 (see diagram). Figure 4 and Figure 10 ).

[0063] 515 optical tube ( Figure 21The indicator LED 520 on plate 540 is aligned with the bottle roller 240. The surface of the end of the light tube 515 outside the bottle roller 240 is textured to disperse the light from the indicator LED 520. When placed in the container 220, the pleated ring cap 410 interrupts the bottle detector 536 (e.g., an optical switch or proximity sensor). The indicator LED 520 and the bottle detector 536 are positioned on plate 540 located on the inner side of roller 240 at the corresponding positions of each bottle 230 in the roller 240 that can be placed by the user. The bottle detector 536 is monitored when the door to the module is opened to detect in real time when a bottle 230 is placed in or removed from the container.

[0064] refer to Figure 20A The user places the bottle 230 into the container 220 by inserting the bottle 230 neck-first until it contacts the flat spring 510, and then pushing the bottle 230 against the spring 510 until the bottom 416 of the culture bottle slides over the lug 417, which holds the bottle 230 in the container 220. The flat spring 510 engages the culture bottle 230 such that if the user does not fully insert the culture bottle 230 into the container 220, the flat spring 510 will prevent the culture bottle 230 from being fully positioned in the container 220. Therefore, the culture bottle 230 will extend sufficiently out of the station so that the roller 240 cannot push the culture bottle 230 through the module housing 224. Once the user closes the module door, this will allow the module 210 to detect any unplaced bottles 230. To remove the bottle 230 from the container 220, the user simply lifts the bottom 416 of the culture bottle above the lug 417 and pulls the culture bottle 230 out of the container 220. In those embodiments where the insertion and removal of culture flasks are automated, the same movements are performed by automated equipment.

[0065] refer to Figure 20C The container 220 is illustrated in more detail with a few modifications. The container 220 is made of a transparent material, so it can be used as a light tube to transfer light from the container status indicator LED 520 inside the roller 240 to the proximal end 420 of the container 220 on the outside of the bottle roller 240.

[0066] After the culture flask 230 is received into the container 220, the flat spring 510 attached to the top of the container 220... Figure 20C The position shown in the middle diagram bends to Figure 20AThe position is shown in the diagram. When the free end 555 of the flat spring 510 contacts the top of the container 220, the spring 510 becomes a hard stop and prevents the culture flask 230 from moving further into the container 220. When the culture flask 230 is released after insertion, the flat spring 510 pushes the culture flask 230 against the lug 417 of the container 220 extending from the outer surface of the roller 240. The culture flask 230 is removed from the container 220 by manually or using a robot to lift the bottom 416 of the culture flask 230 upwards through the proximal end 420 of the container 220.

[0067] Figure 28A The illustration shows that it has Figures 20A-20C and Figure 28B The illustrated image shows a receiver 220 with a flat spring, provided in rows, and the roller 240 is formed by attaching the rows together. Due to the way the rows are assembled, the resulting structure is a circular roller 240 with a circular outer and inner periphery. Figure 29 ).

[0068] Figure 20D The illustration shows that it has Figures 20A-20C The diagram shows a portion of the container 220 with multiple vertical rows of rollers 240. The rollers are illustrated in a sectional view to show the culture flasks 230 supported within the container 220. The top of the container 220 is empty. Figure 20D In the embodiment illustrated, a pivot arm 551 is provided instead of the previously described leaf spring 550 to secure the culture flask 230 in the container 220. As the flask 230 is pushed into the flask container 220, the pivot arm 551 rotates clockwise to secure the culture flask 230 in the container. Resistance to the pivot arm 551 is applied by a coil spring 552 fixed in the container using a pin 556.

[0069] exist Figures 20E-20H The Chinese illustration shows Figure 20D Alternative solutions for the container shown in the diagram. (Reference) Figure 20E , Figure 20D The pivot arm 551 shown in the diagram is replaced by a deformable material 553. In one example, the deformable material 553 is a peristaltic tube, but other conventional deformable materials are considered. A key aspect of deformable materials is their elasticity in returning to their undeformed shape after each deformation caused by the insertion of the culture flask into the container. The bottom portion of the container 220 is a light tube 515.

[0070] Deformable material 553 is placed in the conical portion 554 of the housing 220. (Reference) Figure 20F The end view of the container 220 illustrates the deformable material 553 at the top of the container (along the tapered portion 554 of the container). In addition to the elastomeric peristaltic tube described above, suitable deformable materials include elastomeric materials and foam materials.

[0071] Figure 20G This is a perspective view of a container 220, with a portion of a second container formed above it. The culture flask is held in the container as described above. Lugs 417 securely hold the culture flask 230 in the container 220. Other deformable materials, such as those with sufficient frictional properties when in contact with the flask 230, are considered. This friction prevents rotation of the flask 230, thus allowing the measurement system to obtain high-quality signals with less noise caused by the rotational vibration of the flask and the flask's rotation.

[0072] refer to Figure 22 If the bottle is not fully inserted into the container 220, the flat spring 510 will hold the bottle in the overturned position 570. Thus, when the bottle is not fully inserted into the container 220, the culture bottle 230 appears not to be properly positioned within the container 220. When the culture bottle 230 is in the container but not fully positioned, the bottom 416 of the culture bottle will not allow the bottle roller 240 to be rotated by the module. The module detects the misplaced bottle 570 by detecting a stuck bottle roller 240 and sends a signal to the system. The user will be notified to clear the obstruction by removing or fully inserting the bottle 230.

[0073] The inward-facing neck orientation of the culture flask offers several improvements over the outward-facing neck orientation of the prior art. In the prior art, the roller holds the culture flask at a 20° angle above horizontal during reading. With the neck facing inward, rotating the flask roller forces the culture medium / resin in the flask towards the bottom. Therefore, in the inward-facing neck configuration, the culture flask can be held horizontally within the roller. During optical interrogation of the flask, the roller spins at a speed that forces the culture medium / resin in the flask to a standard 20° angle relative to the side of the flask. For a roller with a diameter of 22 inches, the roller diameter is measured from the bottom of the flask on one side of the roller to the bottom of the culture flask on the opposite side of the roller. A roller rotation speed of approximately 37 RPM induces a 20° angle for the culture medium / resin towards the bottom of the flask. For comparison, the rotor in the prior art device spins at approximately 30 RPM, used both for reading the culture flask and for agitation. Alternatively, the roller rotation speed can be selected to cause the roller to operate like a centrifuge, driving additional separation of the solid portion (i.e., culture medium and resin) of the sample from the liquid portion.

[0074] Figure 26The illustration shows a bottle stop 1000 that can be placed at the end of a bottle holder 220. The bottle stop 1000 is a simple keyhole-shaped slot 1010 having a top opening 1015 with a perimeter sufficient to allow the pleated cap of the culture flask to pass through. When the culture flask is in the holder 220, the neck of the flask sinks into a narrower opening 1020 of the keyhole-shaped slot 1010, which is not wide enough for the pleated cap of the culture flask to pass through. Therefore, the keyhole-shaped slot 1010 holds the culture flask in place within the bottle holder until it is removed manually or by automation (e.g., by a robot).

[0075] The culture flasks, with their necks facing inward, require the measuring electronics to be located on the periphery of the flask rollers. As illustrated herein, these electronics are positioned in the right front corner. The bottoms of the culture flasks are spaced further apart in the neck-inward configuration than in the neck-outward configuration. This reduces any possible crosstalk in the measurement system (e.g., reduces or eliminates crosstalk from fluorescence emission from flasks adjacent to the one being measured).

[0076] As explained in this article, the module rotates the rollers to position the bottles for both user pick-and-place and automated pick-and-place. The module also rotates the culture flasks to agitate them.

[0077] Alternatively, the roller motion system has a direct drive motor mounted to the axle, with roller bearings mounted on the axle, and the roller rotating around the axle. Direct drive motors eliminate the need for additional parts required by drive or flange-driven motors. Direct drive motors are a more reliable solution and produce less noise than other conventional motors.

[0078] To agitate the flask within the rollers holding the flask outwards from the neck, the rollers are accelerated to force the culture medium / resin into the neck of the flask using centrifugal force. The rollers are then decelerated to allow the culture medium / resin to flow back to the bottom of the culture flask. Optionally, this motion profile is repeated approximately every two seconds to generate motion of the culture medium / resin within the flask, mimicking the motion of the culture medium / resin when the culture flask is shaken in prior art equipment.

[0079] The horizontal acceleration of the flask that occurs during the angle-accelerated agitation process described above does not occur in prior art equipment, and the resulting agitation is advantageous. Alternatively, the roller will be operated to provide low-frequency acceleration and deceleration through a large angle. This motion will move the liquid (i.e., culture medium / resin / sample) in the culture flask from the base of the flask to its neck and back.

[0080] Optionally, the rollers will be operated to provide high-frequency acceleration and deceleration through small angles. This motion will move the liquid (i.e., culture medium / resin / sample) in the culture flask from one side to the other. This motion is similar to the motion imparted to the liquid in the culture flask by existing technology equipment.

[0081] Alternatively, variations and combinations of the above motion profiles are considered when the roller moves back and forth or in a single direction.

[0082] Alternatively, the roller is operated to provide periodic, sudden deceleration to expel blood, resin, and bacteria that may have settled in the bottle. Some bacteria will be damaged by this continuous, vigorous agitation. This movement is infrequent during instrument operation (e.g., once per hour or at the end of each measurement cycle).

[0083] Alternative mechanisms for moving the bottle rollers have been considered to replace the direct-drive motor and bearings on the solid wheel axle described above. The objectives of such alternative mechanisms are: i) to minimize the vertical space between the bottle rollers; to minimize the space between the rollers to increase the bottle density in the cabinet; and iii) to provide the user with a more uniform row of bottles during manual workflows.

[0084] One example is a disc conveyor mounted to a geared ring (GAR), which rotates on a ring bearing and is driven by a motor and toothed belt. Bottle rollers in the module can be similarly mounted to a GAR and driven by a toothed belt. The bottle rollers will open at the top, and all connections to the electronics inside the rollers will be routed above the rollers.

[0085] Figure 23 The illustration shows a roller 240 rotating on a large-diameter ring bearing 600. The curvature of the roller 240 is evident in its change in distance and angle from the bottle container 220, which has its neck facing inwards, meaning the measuring system (not shown) is located outside the roller assembly. The illustrated embodiment accommodates a belt-driven base of a motor located outside the roller. Alternatively, a direct-drive motor and ring bearing located at the center of the base can be used. Compared to the sensitivity of measuring systems in prior art systems to rotor speed, the measuring system in the module described herein is less sensitive to the speed of the bottle roller.

[0086] refer to Figure 24 The device described herein may optionally include LEDs for source lighting, the LEDs having a first color (e.g., green) or a second color (e.g., blue). Additional LEDs obtain reference readings. (As in...) Figure 24As observed, the light indicating the reference reading is activated when the indicator staining (bromocresol purple (BCP) in the positive state (percentage of transmittance) is equal to that in the negative state of BCP). A positive indication is obtained when the percentage of transmittance in the positive state exceeds that in the negative state. The wavelength of the blue LED is at a point on the response curve unaffected by the pH state of the blood culture in the culture flask. The ratio of the reading from the flask using blue excitation light to the reading obtained using green excitation light should be proportional to the slope of the BCP response curve, which is proportional to the pH state of the BCP. The pH reading from the BACTEC flask is an indicator of improved biological growth in the flask.

[0087] The device described in this paper offers the following advantages: 1) reduced noise (i.e., the ratio of the growth signal to the reference signal should be unaffected by bottle position, temperature, and sensor variability); 2) detection of growth in vials experiencing delays in the input system (i.e., the dual measurements described above provide a reference so that the contents of the vials do not need to be continuously sampled during growth to confirm positivity by detecting growth acceleration); and 3) a signal quality indicator (i.e., the reference signal is an independent indicator of the health of the station hardware).

[0088] This document also describes a method for operating the device described herein. The method controls the movement of the bottle rollers to support a user workflow. The user requests the module door to open for loading and unloading of the bottle rollers containing blood culture bottles, as illustrated herein. The bottle rollers are stopped at a specific position by the bottle roller drive motor before the door opens. As described above, when the module door is open, only one sector of the bottle rollers can be loaded and unloaded by the user. The user can indicate to the control system which sector of the rollers they wish to load and unload.

[0089] Once the door is opened, the door interlock switch reduces the maximum power delivered to the bottle roller motor. In this way, the bottle roller motor drives the bottle roller at low power and low speed. The status of the bottles in the bottle roller is indicated by light near each culture bottle holder within the bottle roller. As described herein, the light source and sensor are located in fixed positions inside the bottle roller module. When a station is aligned with the light source, the light source illuminates a light tube for the station within the bottle roller.

[0090] The user places or removes culture flasks from the bottle rollers to insert them into available stations (also referred to herein as bottle holders). The user removes culture flasks with a target status (i.e., positive or negative). For example, positive flasks are placed or removed by the user for further examination; negative flasks are collected for disposal. Once the user has completed placing or removing a section of the roller, the user is allowed to manually move the roller left or right, overcoming the small resistance to rotation exerted by the motor. The change in roller position is sensed by the control system, which effectively removes the force exerted by the motor, allowing the roller to rotate relatively freely. Once the control system releases the roller from the motor resistance to manual rotation, the control computer determines the next position of the bottle roller where the user will be allowed to place or remove the culture flask of interest. When the culture flask of interest is available for the user to place or remove, the control system sends a signal to the bottle roller motor to stop the bottle roller in that position.

[0091] As the bottle rollers rotate, the bottle status indicator light is illuminated, allowing the status of the culture bottles to be accurately indicated via a light tube aligned with the bottle holder / station. The bottle roller control system includes an encoder that communicates with the system, ensuring that the control system knows the position of the bottle rollers at all times (and therefore the position of each holder / station at all times). As the bottle rollers advance a holder / station from one position to the next, the control system illuminates each holder / station.

[0092] In the methods described above, it may be undesirable for the user to manually advance the rollers or disc conveyor. This paper considers systems with controls that allow the user to advance the rotation of the rollers to reveal additional bottles. Such controls could simply be buttons or icons on a touch panel that allow the user to advance the rollers clockwise or counterclockwise. If the system described herein is equipped with such controls, it prevents the user from overriding those controls and manually moving the rollers. Such controls can be used to advance the rollers or disc conveyor incrementally (i.e., intermittently actuated) or continuously (through sustained actuation).

[0093] In this specification, the word "comprise" should be understood in its "open" sense, that is, in the sense of "including," and therefore not limited to its "closed" sense, that is, not limited to the sense of "consisting of only." The corresponding meanings belong to the corresponding words "comprise," "comprised," and "comprises" in the places where they appear.

[0094] While specific embodiments of this technology have been described, it will be apparent to those skilled in the art that the technology can be implemented in other specific forms without departing from its essential characteristics. Therefore, these embodiments and examples are to be considered illustrative rather than restrictive in all respects.

[0095] It should be further understood that, unless otherwise indicated, any reference in this document to subjects known in the art is not an admission that such subjects are commonly known to those skilled in the art.

Claims

1. An apparatus for storing and monitoring blood culture bottles, the apparatus comprising: A roller having an outer periphery and an inner periphery, the outer periphery having a diameter greater than that of the inner periphery, the roller having a plurality of receptacles, each of the plurality of receptacles having a proximal end at the outer periphery and a distal end at the inner periphery, each receptacle being configured to receive a blood culture bottle, the blood culture bottle comprising a bottom portion and a neck portion, wherein the blood culture bottle is receptable to the receptacle such that the bottom portion is received at the proximal end of the receptacle and the neck portion is received at the distal end of the receptacle; The inner periphery and the outer periphery are arranged around the rotation axis of the roller, wherein the rotation axis is vertical relative to the surface supporting the roller; The plurality of seats are arranged in the roller in an array of seats, the array having seats arranged vertically and horizontally; The roller has a plurality of panels defining vertical roller sectors, and each vertical roller sector has an equal horizontal span, and each span makes the horizontal span of a sector the same as the horizontal span of the housing door; Multiple sensors and detectors aligned with each of the plurality of containers, the multiple sensors and detectors being used to interrogate changes in the microbial growth indicator of the blood culture bottle to determine whether the blood culture bottle is positive or negative for microbial growth; and The roller defines an internal space within its inner periphery, wherein at least a portion of the roller electronics that communicate with the sensors and detectors used to inquire about changes in a microbial growth indicator of the blood culture bottle are disposed within the inner periphery of the roller.

2. The device according to claim 1, wherein a plurality of rollers are disposed in the housing.

3. The device according to claim 2, wherein the housing has a door for picking up and putting down each roller disposed in the housing.

4. The device according to any one of claims 2 and 3, wherein the housing has a touch screen.

5. The device of claim 2, wherein the housing further comprises a support for receiving blood culture bottles for placement in or removal from the device.

6. The device of claim 1, wherein the device further comprises a drive motor for rotating the roller disposed in the housing.

7. The device of claim 1, wherein the measuring electronics are disposed within the internal space defined by the internal periphery of the roller.

8. The device of claim 1, wherein the blood culture bottle indicator electronics are disposed within the internal space defined by the internal periphery of the roller.

9. The device according to claim 1, further comprising a heater disposed in the housing outside the outer periphery of the roller.

10. The device according to claim 1, further comprising a blower disposed in the housing outside the outer periphery of the roller.

11. The device of claim 6, further comprising an axle and at least one bearing, the axle defining the axis of rotation, the at least one bearing being coaxially disposed with the axle and the roller to allow the roller to rotate about the axle.

12. The device according to claim 11, wherein the at least one bearing is a ring bearing.

13. The device of claim 1, wherein the rollers are assembled in layers, each layer being at least a portion of an entire row of the receptacle, and each layer having the inner periphery and the outer periphery.

14. The device of claim 1, wherein the rollers are assembled in rows of segments, each row of segments defining only a portion of the inner periphery and the outer periphery of the rollers.

15. The device of claim 1, wherein each of the plurality of containers has a corresponding elastomeric insert for receiving a blood culture bottle.

16. The apparatus of claim 1, wherein each of the plurality of receptacles receives the neck portion of the blood culture bottle at the distal end, and each receptacle includes a bottle stop and a helical spring spaced apart from the bottle stop, the helical spring being biased such that, when the neck portion of the blood culture bottle is inserted into the receptacle, a cap disposed on the neck portion of the blood culture bottle passes through the helical spring and advances to abut against the bottle stop, whereby the helical spring releases tension and secures the blood culture bottle in the receptacle.

17. The device of claim 1, wherein each of the plurality of containers receives the neck portion of the blood culture bottle at the distal end, and each container includes a bottle stop and an O-ring spaced apart from the bottle stop, the O-ring being sufficiently resilient to allow a cap disposed on the neck portion of the blood culture bottle to pass through the O-ring and advance to abut against the bottle stop, whereby the O-ring releases tension and secures the blood culture bottle in the container.

18. The apparatus of claim 1, wherein each of the plurality of receptacles receives the neck portion of the blood culture bottle at the distal end, and each receptacle includes a bottle stop and a ball stop spaced apart from the bottle stop, the ball stop being biased such that when the blood culture bottle is inserted into the receptacle, a cap disposed on the neck portion of the bottle passes through the ball stop and advances to abut against the bottle stop, thereby releasing tension on the ball stop and securing the blood culture bottle in the receptacle.

19. The device of claim 1, wherein each of the plurality of receptacles receives the neck portion of the blood culture bottle at the distal end, and each receptacle includes a bottle stop and a segmented retaining portion spaced apart from the bottle stop, the segmented retaining portion being biased to allow a cap disposed on the neck portion of the blood culture bottle to enter the segmented retaining portion and advance to abut against the bottle stop, thereby releasing tension on the segmented retaining portion and securing the blood culture bottle in the receptacle.

20. The device of claim 19, wherein the retaining portions of the segments are forced together by a helical coil spring.

21. The device of claim 19, wherein the retaining portion of the segment is an elastic segment.

22. The device of claim 1, wherein each of the plurality of containers receives the neck portion at the distal end, and each container includes a bottle stop and a plurality of resilient wings extending from the bottle stop, the plurality of resilient wings being biased such that when the culture bottle is inserted into the container, a cap disposed on the neck portion of the blood culture bottle passes through the flange portions of the plurality of resilient wings and advances to abut against the bottle stop, whereby the plurality of resilient wings release tension and the flange portions secure the blood culture bottle in the container.

23. The device of claim 22, wherein each of the plurality of receptacles further comprises a ball stopper, and the bottle stop comprises a notch, wherein, When the blood culture bottle is pushed into the bottle stop, the bottle stop is further pushed into the container until the ball plug is aligned with the notch, thereby fixing the bottle stop in the container.

24. The device of claim 22, wherein each of the plurality of receptacles further includes a notch, and the bottle stop includes a ball stopper, wherein, When the blood culture bottle is pushed into the bottle stop, the bottle stop is further pushed into the container until the ball plug is aligned with the notch, thereby fixing the bottle stop in the container.

25. The device of claim 1, wherein each of the plurality of containers further comprises a tray portion on which the blood culture bottle is placed, the tray portion comprising a lug for securing the bottom portion of the blood culture bottle in the tray portion, and the container further comprises a stop portion wherein the stop portion positions the blood culture bottle in a predetermined fixed position within the container.

26. The device of claim 25, wherein the stop portion comprises a leaf spring.

27. The device of claim 25, wherein the stop portion comprises a deformable material.

28. The device of claim 27, wherein the stop portion further comprises a pivot arm that pivots in response to the blood culture bottle being advanced into the container, thereby securing the blood culture bottle in the container.

29. The device of claim 25, wherein the stop portion comprises an elastic material selected from one of an elastomeric flexible tube, an elastomeric material, or a foam material.

30. The device of claim 25, wherein the tray portion further comprises a light tube that transmits light signals from an indicator LED disposed within the inner periphery of the roller to a photodetector positioned on the outer periphery of the roller.

31. The device of claim 25, wherein the stop portion comprises a keyhole-shaped element.

32. The device according to claim 1, wherein the outer periphery of the roller and the inner periphery of the roller are circular.

33. The device according to claim 1, wherein the outer periphery of the roller and the inner periphery of the roller are divided into blocks.

34. A method for controlling an incubator for multiple blood culture flasks, the method comprising: A predetermined sector of the blood culture roller is input via a control interface. The blood culture roller includes a support that rotates about a vertical axis and defines an inner and outer circular perimeter, wherein the blood culture roller is a rotating roller. Open the door of the housing for the blood culture roller; The blood culture roller is stopped by reducing the power of the motor used to rotate it, making the predetermined sector accessible via the open door of the housing; The blood culture roller includes a plurality of containers, each of which is adapted to receive and hold a blood culture bottle, wherein the blood culture bottle is received by the plurality of containers such that a bottom portion is received at a proximal end of the container and a neck portion is received at a distal end of the container, wherein each of the plurality of containers has an indicator at its proximal end, the indicator providing an indication of whether the blood culture bottle in the container is positive or negative for microbial growth; The blood culture roller defines an internal space within the circular inner periphery, wherein at least a portion of the roller electronics communicating with sensors and detectors for querying changes in microbial growth indicators of the blood culture bottle are disposed within the circular inner periphery of the blood culture roller, and the blood culture roller further has a plurality of panels defining vertical roller sectors, each vertical roller sector having an equal horizontal span, and each span such that the horizontal span of a sector is the same as the horizontal span of the housing door; Inquire about changes in the microbial growth indicator of the blood culture bottle to determine whether the blood culture bottle is positive or negative for microbial growth; and At least one of the following: inserting the blood culture bottle into an empty seat of the plurality of seats, removing the blood culture bottle from a seat of the plurality of seats, or removing the blood culture bottle from one seat of the plurality of seats and inserting a different blood culture bottle in its position, wherein the blood culture bottle was removed based on its indication of whether microbial growth was positive or negative.

35. The method of claim 34, wherein each of the receptacles further comprises a light tube extending from a proximal end of the receptacle to a distal end of the receptacle.

36. The method of claim 34, wherein the control interface communicates with the encoder such that the control interface tracks the placement of each blood culture bottle in the support.

37. The method of claim 35, wherein the incubator further comprises a reader station, wherein as the blood culture roller rotates past the container carrying the blood culture bottle, the reader station determines whether the blood culture bottle is a positive or negative indicator for microbial growth.

38. The method of claim 37, wherein the incubator further comprises an indicator LED located at the distal end of at least a portion of the container in the blood culture roller.

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