Drum-type container rack for blood culture bottles and measurement and operation methods

Abstract

An apparatus for storing and monitoring blood culture bottles. The apparatus has a movable rack configured as a drum with multiple receptacles for receiving blood culture bottles. The drum is disposed within a housing. The housing includes a heater and a blower for keeping the blood culture bottles warm at an elevated temperature. The receptacles have light pipes for providing indications of bottle status as determined by the apparatus. The apparatus has a housing with multiple cabinets therein. Each cabinet has a molded foam insert heat distribution assembly therein. Each molded foam insert heat distribution assembly is in fluid communication with a heater / blower assembly. The apparatus may also have a drum motor encoder attached to a motor located at the center of the movable drum-shaped rack. The motor encoder detects whether the drum-shaped rack is aligned or out of alignment and increments manual or automatic rotation of the drum-shaped rack.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 432,460, filed December 14, 2022. This application also claims the benefit of, and is related to, U.S. Provisional Patent Application No. 63 / 390,452, filed July 19, 2022. Both provisional applications are incorporated herein by reference. This application is also related to PCT Application PCT / US2020 / 045065, filed August 5, 2020, which is incorporated herein by reference.

[0002] The present invention relates to a non-invasive device for detecting biological activity in specimens, such as blood, in which a large number of specimens are introduced into a large, sealed container along with a culture medium and exposed to conditions that allow various metabolic, physical, and chemical changes to occur in the presence of microorganisms in the sample. These changes are then monitored using calorimetric or fluorescent chemical sensors located on the inside bottom of each blood culture bottle as it rotates 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 biologically active substances such as bacteria in a patient's body fluids, especially blood, is commonly determined using blood culture bottles: a small amount of blood is injected through a packaging rubber septum into a sterile bottle containing a culture medium, which is then incubated at approximately 35°C and monitored for microbial growth.

[0004] Because it is of paramount importance to know whether a patient has a bacterial infection, hospitals and laboratories have automated devices that can process many blood culture bottles simultaneously. One example of such a device is the BD BACTEC™ system, manufactured and sold by Becton, Dickinson and Co. U.S. Patent No. 5,817,508 to Berndt et al. describes a prior art blood culture apparatus and is incorporated herein by reference. Further description of blood culture apparatus is provided in U.S. Patent No. 5,516,692 ("Compact Blood Culture Apparatus") and U.S. Patent No. 5,498,543 ("Sub-Compact Blood Culture Apparatus"), both of which are incorporated herein by reference.

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

[0006] As shown in FIGS. 1 and 2 , a plurality of such bottles 1 are radially arranged on a rotating bell-shaped drum 2 within an incubator 5, with the bottoms of the bottles 1 oriented toward the drum axis 28. The bell-shaped drum 2 is hollow and supported by a shaft 24, which is rotatably supported at one end by two large ball bearings 3 and 4 mounted on a first side 51 of an instrument body 50. To read information from each optical chemical sensing means 20 in the bottles 1, a linear array of sensor stations 12 is mounted within the rotating bell-shaped drum 2 up to a second side 52 of the instrument body 50, at a distance inside the bell-shaped drum 2 such that each bottle 1 passes a respective sensor station 15 in the array 12 during rotation of the drum 2. Each sensor station 15 in the linear array of sensor stations 12 includes an excitation light source 11 and a collecting end 14 of an optical fiber.

[0007] The axis 28 of the bell-shaped drum 2 is oriented horizontally, parallel to the door 13 located at the front of the incubator 5, as shown in FIG. 2. The horizontal orientation of the axis 28 motors maximum agitation of the liquid medium and specimen mixture 22 and gas within each bottle 1. The door 13 is opened during loading or unloading operations, allowing access to approximately one-third of all bottles 1 simultaneously. The drum 2 then rotates until the next third of the bottles 1 are accessible. In three steps, all bottles 1 are accessible.

[0008] Alternatively, the axis 28 of the bell drum 2 is oriented vertically with an approximately 20 degree incline away from the door 13. The degree of agitation can be modified by adjusting the angle of incline as needed to maintain optimal growth conditions.

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

[0010] The device shown in Figures 1 and 2 includes 10 segments of blood culture bottles 1, with 36 bottles 1 per segment, for a total capacity of 360 bottles. This arrangement of bottles 1 on the drum 2 allows for a relatively high packing density, although improvements in density are still being sought. Summary of the Invention

[0011] Described herein is an apparatus for storing and monitoring blood culture bottles. The apparatus has a movable rack configured as a drum having multiple receptacles for receiving the blood culture bottles. The drum is disposed within a housing. The housing includes a heater and a blower for keeping the blood culture bottles at an elevated temperature. The housing may include other features, such as vents, baffles, dampers, etc., to further regulate and control the temperature and temperature profile within the housing. Optionally, the apparatus has multiple drums, each having multiple receptacles for receiving the blood culture bottles.

[0012] Described herein is an apparatus for storing and monitoring blood culture bottles. The apparatus includes a drum-shaped rack having an outer periphery and an inner periphery, the outer periphery having a diameter greater than the diameter of the inner periphery. The drum includes a plurality of receptacles, each having a proximal end at the outer periphery and a distal end at the inner periphery, and configured to receive one blood culture bottle. The blood culture bottle includes a base and a neck. The bottle can be received in the receptacle either by its base or by its neck. In one embodiment, the drum periphery is disposed about an axis of rotation of the drum. In any of the above aspects, the multiple receptacles are arranged on the drum as an array of receptacles, the array having receptacles arranged both vertically and horizontally, with vertically aligned receptacles forming columns and horizontally aligned receptacles forming rows. The apparatus may also include a bottle status indicator panel removably mounted on the inner periphery of the drum-shaped rack, the bottle status indicator panel having multiple bottle presence sensors and multiple bottle status indicator lights forming an array, the array configured so that the bottle presence sensors align with the receptacles, thereby enabling the presence or absence of a bottle to be detected by the bottle presence sensors. The status indicator lights are positioned opposite light pipes associated with the receptacles, such that the status indicator lights illuminate the light pipes to indicate the status of the bottles in the receptacles. The status reflects whether the blood culture bottles contained in the receptacles are positive or negative for microbial growth. In one embodiment, the drum defines an interior space within an inner periphery, and at least a portion of the drum electronics is disposed within the inner periphery of the drum in communication with sensors and detectors for testing the blood culture bottles.

[0013] In a further aspect, the motor is positioned within the inner periphery of the drum-shaped rack. In a further aspect, the drum-shaped rack may have multiple compartments, each compartment of the drum-shaped rack having multiple columns of receptacles and multiple rows of receptacles, with at least one compartment being removable from the frame of the drum-shaped rack. In a further aspect, the bottle status indicator panel is removably coupled to the frame behind the compartment. Furthermore, the number of rows of bottle presence sensors and the number of rows of bottle status indicator lights in the bottle status indicator panel correspond to the number of rows of receptacles in the compartment of the drum-shaped rack.

[0014] In a further embodiment, the drum is vertically movable relative to the motor. In this embodiment, the drum has a lifting device for raising the drum relative to the motor. The device may also have a locking device for supporting the drum on the frame when the drum is in the lifted position. In any of the above embodiments, the device further includes a measuring board including a sensor for determining the status of the bottle as the container is moved past the measuring board. In such an embodiment, the bottle status is one of positive for microbial growth or negative for microbial growth. In such an embodiment, the measuring board may be placed adjacent to the periphery of the drum-shaped rack. In such an embodiment, the measuring board may have an alignment sensor. One example of an alignment sensor is a magnetic proximity sensor (also known as a Hall effect sensor) placed adjacent to the measuring board or incorporated as a component of the circuit board. Such a sensor will detect a magnet attached to the drum near the first row of bottles, often referred to as the origin. Another example of an alignment sensor may be an optical detector. In a further embodiment, the alignment sensor is configured to detect a flag positioned on a panel defining each compartment of the drum-shaped rack. In one embodiment, the flag is a flange extending from the panel that passes through the optical beam of an optical detector. Blocking of the detector's optical beam indicates that the flag has passed the optical detector. In another example, alignment of the drum with the status panel is achieved through monitoring readings from an optical sensor on the status panel itself, which may be programmable and provide a digital reading of the object's proximity to the motor. This digital reading may be used to sense the edge of the bottle queue station, which, when correlated with the value of the drum motor encoder, forms the basis for an automatic drum-to-status panel alignment feature.

[0015] In one embodiment, the flags are alignment flags and compartment flags. Each compartment of the drum-type rack has a different flag distribution. In one embodiment, alignment is indicated when the alignment flags interrupt the optical beams at the alignment sensors. In a further embodiment, when alignment is indicated, the compartment of the drum-type rack is determined. In one embodiment, the pattern of the detected compartment flags indicates the drum compartment aligned with the door of the housing for the drum-type rack. [Brief explanation of the drawings]

[0016] [Figure 1] 1 is a front view of the interior of a prior art blood culture apparatus for microbial detection. [Figure 2] FIG. 1 is a side view of the interior of a prior art blood culture device. [Figure 3A] FIG. 1 is a perspective view of a blood culture device housing for a module described herein. [Figure 3B] FIG. 1 is a perspective view of a blood culture device housing for a module described herein. [Figure 4] FIG. 1 is a top view of an insulation and measurement module according to one embodiment of the present invention. [Figure 5A] FIG. 2 is a side view of the bottle rack drum. [Figure 5B] FIG. 1 is a side view of a bottle rack drum with a section removed to reveal the BDSI board. [Figure 5C] FIG. 2 is a partial top view of the bottle rack drum. [Figure 6A] FIG. 10 shows a lifting mechanism for servicing the motor inside the drum. [Figure 6B] FIG. 10 shows a lifting mechanism for servicing the motor inside the drum. [Figure 6C-6D] FIG. 10 shows a lifting mechanism for servicing the motor inside the drum. [Figure 6E] FIG. 10 shows a lifting mechanism for servicing the motor inside the drum. [Figure 7A] FIG. 1 is a diagram showing a BDSI board. [Figure 7B]FIG. 1 shows a diagram of a measuring board and a controller board connection forming part of the measuring board. [Figure 7C] FIG. 10 shows alignment sensors and section identification sensors on the controller board. [Figure 7D] FIG. 10 is a diagram showing an alignment flag and a section identification sensor flag. [Figure 7E] FIG. [Figure 8] FIG. 10 illustrates the configuration of the alignment flag and compartment identification flag that indicate to the BDSI board which drum compartment is aligned with the drum module door. [Figure 9] FIG. 10 illustrates one example of the progression of light patterns on the drum / bottle status panel used to guide the user to align the drum with the BDSI board. [Figures 10A-10B] 1A-1C illustrate aspects of a light source and detector for bottle inspection. [Figure 10C] 1A-1C illustrate aspects of a light source and detector for bottle inspection. [Figures 10D-10I] 1A-1C illustrate aspects of a light source and detector for bottle inspection. [Figure 11] FIG. 6 is a diagram of the drum shown in FIG. 5 with a transparent internally reflective light pipe forming a receptacle for receiving a blood culture bottle. [Figures 12A-12C] FIG. 12 shows a light pipe used in the drum of FIG. 11. [Figure 13] FIG. 1 is a top view of a bottle drum as described herein. [Figure 14] FIG. 1 shows a bottle in a receptacle with a light pipe. [Figure 15A] FIG. 1 shows a bottle held in a receptacle with a light pipe. [Figure 15B] FIG. 1 shows a bottle held in a receptacle with a light pipe. [Figure 15C] FIG. 1 shows a bottle held in a receptacle with a light pipe. [Figure 15D-15E] FIG. 1 shows a bottle held in a receptacle with a light pipe. [Figure 16] FIG. 10 illustrates one embodiment of a drum described herein showing the incremental angle by which the drum is advanced to achieve alignment of the bottle sensor with one rack row of bottles. [Figure 17] FIG. 1 is an open front view of a blood culture warming module adjacent to a module for loading / unloading blood culture bottles into the blood culture warming module according to one embodiment of the device described herein. [Figure 18] FIG. 1 is a diagram of a heater / blower assembly and foam molded insert heat distribution system according to one embodiment of the present invention. [Figure 19] FIG. 19 is an enlarged view of the foam molded insert heat distribution system of FIG. 18. [Figure 20] FIG. 19 is a side cutaway view of the heater / blower assembly and foam molded insert heat distribution system of FIG. 18. [Figure 21] FIG. 19 is a front view of the heater / blower assembly of FIG. 18. [Figure 22] 19 is a perspective view of the upper heater / blower assembly of FIG. 18 as it is placed in the cabinet of the blood culture incubation module of FIG. 17 according to one embodiment of the present invention. [Figure 23] 19 is a perspective view of the lower heater / blower assembly of FIG. 18 as it is placed in the cabinet of the blood culture incubation module of FIG. 17 according to one embodiment of the present invention. [Figure 24] FIG. 1 is a top view of a foam molded insert heat distribution system. [Figure 25] FIG. 1 is a perspective view of the frame of a blood culture incubator module with a foam molded insert heat distribution placed within. DETAILED DESCRIPTION OF THE INVENTION

[0017] Described herein is 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 or infected with microorganisms. The modules described herein can be placed within a cabinet, such as that shown in FIGS. 3A and 3B. The cabinet 200 can provide power to the modules, a controlled thermal environment, and communication channels for the modules. FIG. 3A shows a cabinet 200 with two three-door panels 201 on either side of a central panel 202, which provide access to three bottle drums. The central panel 202 has a touchscreen 203 for data entry and use control. The central panel 202 also has a central station 204 for the insertion and removal of culture bottles. FIG. 3B shows a cabinet with only one three-door panel 201. FIG. 3C shows a cabinet 200 with two dual door panels, and FIG. 3D shows a cabinet with only one dual door panel.

[0018] The number of doors depends on the number of drums. The number of drum racks in a module is largely a matter of design choice, with one, two, and three drum configurations being contemplated herein. The devices described herein are not limited to any particular number of drums.

[0019] The module has a high-density bottle drum. As used herein, high-density describes a drum configuration that allows culture bottles to be placed closer together, allowing a greater number of bottles to fit into the drum than in the prior art. The module is configured to align the bottles with a limited number of reader stations. That is, the number of reader stations is less than the number of bottle receptacles in the drum. Optionally, the drum is operated by a direct drive motor capable of inducing accelerated and decelerated drum motion (i.e., oscillating motion, intermittent rotation, etc.). A heater and blower are provided within the drum housing or in the space above or below the portion of the housing that receives the drum. The heater and blower circulate warm air around the drum. Optionally, the heater and blower are configured to maintain the temperature of the contents of all culture bottles in the drum within a predetermined narrow range of a specific target temperature. The predetermined narrow range is ±0.5°C of the target temperature. The specific target temperature is in the range of 30-40°C. Optionally, the target temperature is 36.55°C. A more uniform temperature allows for a higher set point, since there is less risk of "overheating" the sample. Therefore, the higher and more uniform the temperature, the faster the detection time. A motor can position the drum so that a user or automated device can access any bottle contained in the drum. If a sample in a bottle is determined to be positive for microbial growth, a workflow is initiated to retrieve that culture bottle from the module. The module is configured to support that workflow. The placement of module components, such as blowers, within the module is largely a matter of design choice and will not be described in detail herein. The module may include other features, such as vents, baffles, dampers, etc., to further regulate and control the temperature and temperature profile within the module.

[0020] The module is configured with LEDs and light pipes to indicate positive culture bottles to the user. Referring to FIG. 4, a top view of an optional configuration of the module described herein is shown. The module 210 includes a housing 224, a blower and heater 225 for keeping the bottles 230 warm, and a drum 240 with receptacles for holding the culture bottles. In the illustrated embodiment, a bottle presence sensor 250 and culture bottle presence / status indication electronics 260 are located inside the drum (these electronic components are collectively contained in the BDSI board). A drive motor 270 is provided to rotate the drum 240. In other embodiments described herein, the electronics are located adjacent to the exterior of the drum. The drum 240 housing 224 has six panels 221 that define six drum sectors (222A-222F). As shown, the length of one sector is approximately the same as the length of the housing opening for adding or removing bottles from drum 240, so that approximately one-sixth of the drum contents are available at any given time (assuming the drum is full). Figure 5A is a side view of the drum of Figure 4. Culture bottles (not shown) are disposed, neck-inward, in receptacles 220 within drum 240 and are received by mounts configured as light pipes 515. Motor 270 is a direct drive motor with high torque, little or no hysteresis, providing low noise, reliability, and simplicity.

[0021] In one embodiment, drum 240 is configured such that motor assembly 270 and transmission 271 are located inside drum 240. FIG. 5A shows drum 240 with receptacle 220 (culture bottle not shown) for receiving culture bottles. As described above, drum 240 is assembled with the receptacle 220 compartment, and FIG. 5B shows drum 240 (with one compartment of receptacle 220 removed). Status indicator panel 273, which is best viewed when the panel is removed, is used to illuminate light pipe 515 to indicate the status of the bottle resting on light pipe 515. Status indicator panel (BDSI panel) 273 is also detachable or removable from frame 274 of drum 240. As used herein, "status" refers to the status of the blood culture bottle as determined by module 210. The status of the blood culture bottle can be positive for microbial growth or negative for microbial growth. In one embodiment, the status of the blood culture bottles is communicated by colored lighting in the bottle receptacles within the drum, with a green light indicating a bottle that is negative for microbial growth and a red light indicating a bottle that is positive for microbial growth in one embodiment.

[0022] Referring to FIG. 5C, a top view of the frame 274 with the status panel compartment removed is provided. A cable 275 provides power to the motor assembly 270. Also shown is the bottom 276 of the frame 274. The drive motor assembly 270 drives the drum 240 to rotate axially. Bearings within the transmission of the drive motor assembly 270 provide both axial alignment of the drum 240 as well as the necessary thrust load support required to advance a drum containing a number of bottles 230. Referring to FIG. 6A, the axis AA of the drive motor assembly 270 is aligned with the axis AA of the drum 240. As a result, the center of gravity of the drum 240 / drive motor assembly 270 is on the central axis. The drum 240 / drive motor assembly 270 is provided with a lifting mechanism 272 that lifts the drum 240, thereby exposing the motor assembly 270 for maintenance. In one embodiment, shown in FIG. 6E , the lifting mechanism is a screw 2720 that travels through a motor assembly support plate 2721 and a guide nut 2722. When driven upward, the screw 2720 urges a plate 2723 upward. The plate 2723 moves upward along a guide pin 2726. This raises the drum 240 from the drum support 2400, creating a lifting space 2401 between the drum frame 274 and the rotor 2724 of the motor assembly 270. Referring to FIG. 6C , a locking tool 2402 is provided that is insertable into the lifting space 2401 to lock the drum in place relative to the motor assembly 270, thereby allowing the motor to be serviced without bearing the weight of the drum 240. An example of a suitable locking tool 2402 is shown in FIG. 6D . The illustrated locking tool 2402 has a handle 2403 attached to a support bracket 2404. Locking device 2402 is inserted between rotor 2724 and drum frame 274 (shown in perspective). The weight of rotor 2724 and drum frame 274, which is fastened to the rotor by hex bolts 2725, is supported by maintenance frame 2405 while motor assembly 270 is being maintained. Figure 6E provides a detailed view of lifting assembly 272. Cable 275 provides power to motor assembly 270.As previously described, a screw 2720 is advanced upward through a plate 2721 and a guide nut 2722, raising a support bracket 2723 (which moves along a guide pin 2726) to lift the weight of the drum 240 for servicing the motor assembly 270.

[0023] As previously mentioned, the apparatus is provided with a status indicator panel 273. As explained above with reference to Figures 5A and 5B, the drum 240 is arranged into rows of compartmented receptacles 220, with each compartment having multiple rows (e.g., four). In one embodiment, one row in a compartment is reserved for reference bottles. User access to individual sections within the drum is via doors that provide access to a single section (one of receptacles 220 222A-222F) within the drum 240. A compartmented drum is shown in Figure 4.

[0024] To sense the insertion and removal of bottles and provide feedback to the user while the user is using compartments 222A-222F in drum 240, status panel 273 includes bottle presence sensors 250 (bottle sensors) and culture bottle / status indicator electronics 260 (e.g., lights). See FIG. 7A. Each bottle sensor 250 senses the insertion or removal of a bottle into or from a receptacle 220 in compartments 222A-222F accessible through a door to drum 240. The indicator light illuminates a light pipe 515 in drum receptacle 220, which transmits light visible to a user viewing the receptacle through the open door. This requires that the light pipe 515 in receptacle 220 be aligned with the culture bottle / status indicator electronics 260 on status panel 273. When properly aligned, module 210 can reliably indicate the status of the bottle (e.g., positive for microbial growth or negative for no microbial growth) and detect when a bottle is inserted or removed.

[0025] To access all of the bottles in drum 240, the user must rotate the drum into module 210. Once each section of drum 240 is visible through the open door, the user can verify that the exposed section of drum 240 (one of 222A-222F) is aligned with bottle presence sensors 250 and status indicator lights 260 on status indicator panel 273. Referring to FIG. 7A , in one embodiment, module 210 may have an alignment mechanism (located on measuring panel 545 or BDSI 273) that serves to align receptacles 220 in drum 240 with bottle presence sensors 250 and status indicator lights 260 on status indicator panel 273. Those skilled in the art will appreciate that alignment can be achieved in many different ways and that the alignment mechanism is just one example of a sensor that can be used to align drum 240 with the module door, and thus achieve alignment of bottle receptacles with bottle presence sensors 250 and status indicator lights 260. Such alignment can be performed manually (e.g., an operator aligns the drum panel with the door opening), semi-automatically (a mechanism that the operator can control to incrementally advance the drum until alignment is achieved), or automatically (e.g., by criteria such as an alignment flag).

[0026] In one embodiment, the alignment mechanism also includes alignment flags and compartment identification flags attached to the drum panels that separate the drum compartments. The measuring board or BDSI may include an alignment compartment with an optical sensor that detects the flag on the drum panel as it passes by during drum rotation. See FIG. 5B. The BDSI 273 is positioned adjacent to the interior of the drum so that it can detect the flag on the drum panel 221. The optical sensor, in one embodiment of the modules described herein, is in communication with a main controller that notifies the user / operator of available drum compartments through an open door.

[0027] The status indicator panel 273 is also referred to as the bottle detection and status indication (BDSI) 273. The status indicator panel 273 may be located behind the drum and aligned with the door opening as shown in FIG. 7A. As noted above, the module may also include a measuring panel 545. In one embodiment, the measuring panel 545 is the controller panel shown in FIG. 7B. Referring to FIG. 13, in one embodiment, the measuring panel 545 is secured adjacent to the exterior of the drum 240.

[0028] In one embodiment, each row of status panels 273 is either a single panel or multiple interconnected panels. In the embodiment shown, four rows of status panels are connected to each other, for example, by a flexible ribbon cable (not shown). Measuring panels 545 are connected to a main controller panel (not shown) for system communication. As shown in FIG. 7A, the status panels 273 are mounted inside the drum frame. In contrast, measuring panels 545, which may include alignment sections, are located outside the drum so that flags 2734, 2735 can be detected by sensors 2739 on measuring panels 545.

[0029] 7C , in one embodiment, optional alignment section 2731 can have a row of alignment sensors 2732 and a row of section identification sensors 2733. In one embodiment, the alignment sensors and section identification sensors can all be simple optical switches on measuring board 545. As shown in FIG. 7C , the top row can include four alignment sensors 2732, and the bottom row can include section identification sensor 2733. Alignment sensors 2732 and section identification sensor 2733 can each have a notch 2738 in which a sensor 2739 (e.g., an optical switch) is disposed. Adjacent sections of drum 240 can be separated by vertical panels 221 (also referred to as drum ribs or walls) that extend outward from the outer surface of the drum. Such panels 221 are shown in FIGS. 4 and 6C. As shown in Figure 4, drum panels or ribs 221 on each side of the compartments (222A-222F) align with the fascia 2240 of the housing 224 for a clean appearance when the door is open by the user. The drum ribs 221 also extend to the inner surface of the drum as shown in Figure 5C.

[0030] Each drum rib 221 on the inside of the drum has multiple flags (2734, 2735), one flag 2734 for drum alignment and another set of one or more flags 2735 for section identification below the drum alignment flag 2734. The flags 2734 and 2735 are detected as they pass through notches 2738 and their respective alignment centers 2732 and section identification sensors 2733.

[0031] As mentioned above, each panel or rib 221 carries two flags: an alignment flag and a section identification flag. As can be seen in FIG. 7D , the alignment flag is a continuous flag that runs the length of all four alignment sensors 2732. When the drum rotates such that all four optical switches of the alignment sensor 2732 register the presence of a flag, this indicates that the drum is aligned. In one embodiment, the sensor has an optical beam that transmits through a sensor gap. When a flag enters the gap, the optical beam is interrupted, and this interruption registers as an indication of the presence of the flag. This is referred to as the sensor's "on" state because the sensor detects the presence of the flag in this state even though the flag interrupts the signal. The section flags 2735 are configured as unique identifiers for specific sections of the drum. Therefore, the size and number of section flags vary for each section so that each section generates a unique signal for that particular section. As shown, a sensor 2739 is positioned within each notch 2738 through which the alignment flag / section identification flag passes. The sensors are configured as emitter / receiver pairs, only one of which is shown in FIG. 7C. During normal operation, the signal from the emitter to the receiver is uninterrupted. The flag "breaks" the optical beam as it passes the sensor, providing an indication that the flag is present in the sensor. For a reliable indication of alignment, the alignment flag must interrupt the optical path of all alignment sensors. At that very point, the number of "broken" signals for the section sensors indicates which section is about to rotate into position. Referring to FIG. 8, the number of sensors "activated" by the section flag passing the identifier sensor informs the control software which section is present at the sensor. At the point when the alignment flag 2734 fully activates all alignment sensors 2732, the section identification flag 2735 activates the section identification flag sensor 2733 by a large margin. This ensures that the correct section of the drum 240 is identified when alignment is correct.As previously mentioned, while the alignment flags are the same size and configuration for each section, the section flags each have a unique configuration so that the signal generated by the section flag indicates a particular section of the drum. As noted above, the alignment mechanism described above is one example of a mechanism that may be used to align the drum. Those skilled in the art will recognize other suitable mechanisms for achieving alignment of the drum with the door or other module electronics (e.g., status indicator panel 273).

[0032] In another embodiment, the drum can have a drum motor encoder 2742 in communication with measuring plate 545. In this embodiment, alignment section 2731 includes a Hall Effect sensor 2740. In one embodiment, the Hall Effect sensor is placed approximately in the center of measuring plate 545, as shown in FIG. 7B. The Hall Effect sensor detects a flag, which in one embodiment is magnet 2741. Referring to FIG. 7E, magnet 2741 is positioned on drum rib 221. While this location is an example, placing the magnet on the rib rather than somewhere else on the drum surface allows the magnet to be closer to the Hall Effect sensor, thereby increasing the likelihood that the magnet will trigger the Hall Effect sensor as it passes by. Magnet 2741 is detected by the Hall Effect sensor in a pass-by fashion. Once magnet 2741 is detected, a signal is communicated to the main controller. Now that the main controller is in its starting position, encoder 2742 can then be used to coordinate the drum rotation with the target position of the drum within the cabinet. The alignment serves two purposes. The first purpose is to align the status indicator light 260 of the BDSI 273 with the light pipe 515 of the receptacle 220. The second purpose is to align the drum rib 221 with the fascia 2240 of the housing 224 so that only the portion of the drum between the drum fascias is visible when the door 207 is open. Typically, when one purpose is met, the other purpose is also met and the drums are aligned.

[0033] A drum encoder 2742 (FIG. 6E) coordinates the drum rotation angle with the shaft rotation. When the magnetic flag passes the Hall Effect sensor 2740, the generated signal indicates a home position so the drum encoder can provide information to the main controller to determine the drum position and the amount of shaft rotation required to move the drum from a first position to a second position. While the location of the magnet on the drum's periphery is largely a matter of design choice (as long as the magnet is detected by the Hall Effect sensor as it passes by), it is advantageous for the magnet to be positioned in or near the row of the drum rack reserved for calibration bottles. Referring to FIG. 13, there is a top view of the drum 240 with 24 rows. Each of the six sections 222A-F has four rows of bottle stations. In one embodiment, the drum is modified to include a seventh section containing a single row. This seventh section may contain calibration bottles, which in one embodiment have a constant fluorescent emission. The number of rows in each section and the total number of rows are shown in FIG. 8. When a calibration bottle is placed adjacent to the measuring plate sensor 5451, the fluorescent emission induced by the light source 5451 is detected by measurement and compared to the known fluorescent emission associated with the calibration bottle. If the measured fluorescent emission is within an acceptable tolerance of the known fluorescent emission, the measuring plate detector is determined to be functioning properly. The magnetic flag in one embodiment described herein is located adjacent to this seventh section. Those skilled in the art will understand that the number of rows, number of drums, drum capacity, and other such aspects are matters of design choice and are described herein for illustrative purposes.

[0034] The drum motor encoder is rigidly coupled to the motor shaft 24 of the drive motor assembly 270. The drive motor shaft 24 is coupled to a transmission 271, which is coupled to the bottle drum 240.

[0035] In one embodiment, the main controller has a lookup table of drum conditions that may cause the drum to misalign. The lookup table provides the drum conditions that cause the drum to misalign. For example, an alignment tolerance for the drum 240 can be determined by inputting the drum 240 and recording the load configurations that cause the drum 240 to go from aligned to misaligned. As used herein, an aligned condition is when the bottle presence sensors 250 of the BDSI 273 are aligned with the bottle 230 when the alignment sensors 2732 indicate that the drum is aligned, such that the bottle 230 is detected by each bottle presence sensor 250. A misaligned condition is when one or more of the bottle presence sensors 250 do not detect the presence of the bottle 230 in the bottle receptacle 220 when the alignment sensors 2732 indicate that the drum 240 is aligned. The conditions under which the drum changes from aligned to misaligned are boundary conditions. These boundary conditions are recorded and used to define the alignment tolerance. If the bottle present sensor 250 of a bottle receptacle 220 with a bottle 230 in it is not illuminated when the alignment sensor indicates that the drum is aligned, the drum is determined to be out of alignment. When this occurs, the operator knows that the drum 240 is out of alignment.

[0036] In another embodiment, the drum motor encoder provides feedback to the operator as they manually move the drum. This is accomplished by incrementally controlling the motion of the drum 240, allowing the operator to determine when all bottle presence sensors indicate the presence of a bottle in the receptacle 220. As discussed above, the drum encoder increments drum motion based on shaft rotation. In one embodiment, the drum rotation increment is selected and the amount of rotation of the drum is controlled accordingly. Referring to FIG. 16, an example angular range of incremental rotation of the drum 240 is shown. FIG. 16 illustrates the rotation angle between rows of racks in one example. The rack rotation angle from one row in one compartment to the next row is 13.9 degrees. The rack rotation angle from one row in one compartment to one row in the second compartment is 15.7 degrees. The motor encoder measures the shaft rotation in increments, and based on the increments, the controller can determine the drum rotation angle. Even if the drum is rotated manually, the encoder will increment based on the shaft rotation and the main controller can determine the drum position / alignment based on the shaft increments transmitted from the encoder to the main controller.

[0037] The above mechanism allows the module controller (e.g., gauge board 545 or BDSI 273) to maintain drum alignment without requiring communication with the main controller. Once the module door is opened, gauge board 545 can handle the process of helping the user align the drum to the Bottle Detection and Status Indicator board (BDSI). Whenever proper alignment is determined / indicated as described above, the module displays the station status.

[0038] The main controller may also handle drum alignment before the door opens, so that when a user opens the door, the bottle status of the drum compartment visible when the user opens the door can already be illuminated. In one embodiment, the main controller determines when a local controller (i.e., a controller in a module as opposed to the main controller) activates a status light on the status panel 273. To initiate a manual workflow, for example, the main controller sends a command to a module controller to begin alignment. From there, the main controller or a module controller can manage the drum movement and status display. The local controller may be located anywhere within the module. In one embodiment, the local controller is located on the measuring panel 545. In another embodiment, the local controller may be located on the status panel 273. The door to a module may be opened for various reasons described herein. When the module door is closed, the status light is off. A command from the main controller may initiate alignment. The alignment process begins when the door opens, and the drum is advanced until the alignment flags of all of the alignment sensors mounted on the measuring panel 545 are activated. Once alignment is achieved, when the alignment flag activates the alignment sensor, the compartment sensor and detected compartment flag may determine the particular drum compartment that is aligned with the door, and the local controller may send that drum compartment to the main controller.

[0039] In one embodiment, the main controller interfaces with the status panel 273 and provides a status map for the module 210 based on information from the status panel 273. The status map is updated when a user manually adds or removes bottles from the drum or when an automated device in communication with the module 210 adds or removes bottles. When the door to the module opens, the main controller shares the status map with the status panel 273. As bottles are added or removed from the module 210, the map is updated and shared with the main controller. If the module is not operating in isolated mode, the main controller may share the information with a command center.

[0040] In one embodiment, the local controller enters an error state and instructs the user that the module door should be closed. Conditions that may cause an error state are largely a matter of design choice, but could be such as a drop in module temperature, misalignment, etc.

[0041] As shown in FIG. 7A, the status panel includes multiple lights that can communicate information to the user. Although the lights are located behind the drum 240 and bottle receptacle 220, they communicate information to the user through light pipes 515 in the receptacle 220. In one embodiment, the status panel 273 can communicate information as light patterns / different colored lights. The meaning of the light patterns / colors is a matter of design choice. Examples of information communicated include station / receptacle status (occupied, available, etc.) and bottle status (positive, negative, etc.). The displayed status is communicated from the main controller to the local controllers.

[0042] The measuring board 545 may communicate with a panel that communicates alignment status to the user. FIG. 9 shows one example of the progression of alignment status displayed, with multiple lights to convey information about the alignment status of the equipment. For example, when the alignment flag 221 is not aligned with the alignment sensor 2731, all lights are dark 545_1. As the drum compartment moves into alignment status, the flag begins to activate the alignment sensors, illuminating columns moving from left to right (illuminating the left column first 545_2) or columns moving from right to left (illuminating the right-most column first 545_3). This progression of the alignment flag through the alignment sensors (either left to right or right to left) is shown upon detection of the alignment flag by the second alignment sensor (545_4, 545_5) or the third alignment sensor (545_6, 545_7). When all four alignment sensors detect the presence of the alignment flag, all alignment sensor indicator lights are illuminated (545_8). In another embodiment, the panel simply communicates that there is no alignment (all lights are off) or that there is perfect alignment (e.g., all lights are on).

[0043] After all alignment sensors are illuminated, the status indicator changes to station status 273_9, and the user can begin manual operations such as placing or removing bottles from module 210. The panel still provides alignment indication, but with some inherent tolerance since the drum may move slightly during manual operation. This avoids triggering a misalignment reading, which may require the module to be reconfigured. In one example, even after perfect alignment is achieved, alignment continues to be indicated as long as either the left- or right-edge alignment sensor continues to detect the presence of a flag. If neither alignment sensor detects a flag, then the local controller turns off the indicator light, and a new alignment protocol may begin.

[0044] After alignment is confirmed, panel 273_9, which communicates with status indicator 273, indicates the status of the individual bottles in the receptacle. For example, hatched lights indicate samples negative for microbial growth (column 1, row 1; column 2, rows 3 and 8; and column 4, row 5). Cross-hatched lights may indicate bottles positive for microbial growth (column 1, rows 2, 4, 6, 8, and 9; column 2, rows 1 and 5; column 3, rows 2, 3, 5, 6, and 8; and column 4, rows 2, 3, 7, and 9). Unlit lights indicate that no bottles are present in those locations. One advantage of this design is that the user can manually advance the drum when the door is open. To automatically advance the drum, it is useful to close the door to prevent anything from getting caught in the advancing drum. In one embodiment, the drum may need to be powered down when the door is open. In that mode of operation, the drum cannot be advanced when the door is open.

[0045] In another embodiment, rather than using the light pipes described above in the context of Figure 9 to communicate bottle status, a BDSI panel may be provided external to the drum to communicate alignment information. A BDSI controller would be connected to the BDSI panel to illuminate an indicator, which may be a light pipe, lens, or the like.

[0046] As described above, the rotating drum rotates past the measuring plate 545. (The measuring plate performs a shark fin alignment, not a BDSI alignment.) As the drum 240 rotates past these various detection devices on the measuring plate, measurements occur in what may be described as a "pass-by" fashion, where the rotating drum moves the bottles past the measurement electronics as the measurement is being performed. Measurements are performed to determine whether the blood culture bottles are positive or negative for microbial growth. To do so, measurement sensors on the measuring plate 545 are configured to examine the bottles to determine whether their internal gas composition or pH is dynamic (i.e., changing) in a manner that indicates metabolic activity within the bottle as a result of microbial growth. For example, a bottle that measures an increase in carbon dioxide or a decrease in oxygen concentration over time may be determined to be positive for microbial growth. To make this determination, an optical sensor is aimed at a chemical sensor in the bottle that indicates the bottle condition (e.g., oxygen concentration, carbon dioxide concentration, pH). The location of the chemical sensor within the bottle depends on what the sensor is measuring. The headspace of the bottle is the portion of the interior of the bottle where the gas is separated from the liquid and solids of the blood culture (ie, specimen, nutrients, etc.).

[0047] Because a culture bottle may be tested many times before a determination is made that the bottle is positive or negative for microbial growth, the measurement conditions must be sufficiently consistent between measurements, or adjustments to the measurements may need to be made in cases where there are distance variations, i.e., the light from the test sensor 2501 and the distance from the bottle sensor to the photodiode detector 2602 should remain relatively constant between measurements.

[0048] As described above, as drum 240 with rows of bottle receptacles 222 rotates past measuring plate 545, the bottles are inspected row by row. Referring to FIGS. 10A-10I, a sensor (e.g., light source 5451) and detector 5452 are provided within housing 5450, which is fastened to and extends from measuring plate 545. Light source 5451 is positioned around a single photodetector (photodiode 5452). The housing has a fastening mechanism (flange 5453) for fastening housing 5450 onto measuring plate 273. As shown in FIG. 10B, housing 5450 has port 5454 for receiving light source 5451 and port 5455 for receiving photodiode detector 5452. Ports 5454, 5455 are configured so that light source 5451 surrounds photodiode detector 5452 and is configured so that light source 5451 is angled towards photodiode detector 5452 so that the light emitted by light source 5451 intersects over photodiode detector 5452 on a bottle sensor (not shown) directly opposite photodiode detector 5452.

[0049] As the distance between the bottle and measuring plate 545 increases, the combination of spreading of the excitation light from light source 5451 and the fluorescence emitted by the bottle sensor, which is further away from photodiode detector 5452, will decrease the signal generated by photodiode detector 5452. To ensure consistency between measurements at the intersection of the light from light source 5451 with the bottle sensor, light source 5451 can be positioned radially farther away from photodiode 5452. Advantageously, the light emitted by light source 5451 intersects with the bottle behind the bottle sensor, directly opposite the photodiode. The intersection point is far enough behind the bottle sensor that the sensor illumination is off-center so that the fluorescence emitted by light source 5451 is partially outside the field of view of photodiode 5452.

[0050] As the bottle moves away from measuring plate 545, light from light source 5451 converges onto the center of a bottle sensor disposed on the blood culture bottle and thus moves into the field of view of detector 5452. The additional fluorescence of this sensor is caused by the additional light from the light source striking the bottle sensor, offsetting the decrease in fluorescence detected by detector 5452 due to the fact that the bottle and the sensor in the bottle are slightly distant from detector 5452.

[0051] Referring to FIG. 10C, housing 5450 has eight light sources 2501 therein. Four of the light sources are a first color and are designated 2501_1. The light sources are light-emitting diodes (LEDs). In one embodiment, four of the light sources are a second color and are designated 2501_2. In one embodiment, the first color is green and the second color is cyan. As shown, the light source colors alternate around photodetector 2601. At the top right, housing 5450 is shown with ports 5454 for receiving light sources 2501 and 5455 for receiving photodiode detector 2601. FIGS. 10D-10I show the transition of light hitting the bottle sensor (from closer to farther away). FIGS. 10D-10F show this transition for the cyan LEDs, and FIGS. 10G-10I show the transition for the green LEDs (again, from closer to farther away). The above design reduces measurement-to-measurement variability caused by measurement-to-measurement differences in the distance between the light source / photodetector and the bottle sensor. The intensity of a diffuse light source falls off as the square of the distance from the light source. This is why, as the distance between the measuring plate 545 and the bottle increases, the photodiode signal generated by the fluorescent emission due to the light from the light source decreases. Not only does the fluorescent emission intensity received by the photodiode decrease, but the original light intensity striking the sensor also decreases.

[0052] Referring to FIG. 11 , the bottle drum 240 has a receptacle 220 for receiving a culture bottle, as described above, disposed neck-side up. The receptacle 220 has a light pipe 515 formed at the bottom of the receptacle 220, which also defines the bottom edge of the receptacle 220. The light pipe is formed from a material that transmits light through the light pipe structure but does not allow light to emanate from the light pipe to prevent appreciable crosstalk from illuminated to unilluminated light pipes. Examples of suitable materials include polycarbonate (e.g., Makrolon 2258) and acrylic (e.g., polymethyl methacrylate). Makrolon® (formerly Hyzod®) is a trade name of Covestro (formerly Bayer MaterialScience). All of these materials are polycarbonate, a very tough, impact-resistant plastic material. Although translucent materials are contemplated, partially transparent light pipe materials may make it more difficult to perceive the color of the light pipe.

[0053] Referring again to the status indicator panel 273, the LED illuminating the light pipe 515 can be a plurality of LEDs that illuminate the light pipe in many different colors, each color indicating a different status of the blood culture bottle held in the receptacle 220 that contains the light pipe. In one embodiment, the LED illuminating the light pipe is on the status indicator panel and is approximately 5 mm from the light pipe. As described herein, after the culture bottle status is determined, the BDSI, in cooperation with a local or main controller, determines the color to illuminate the light pipe 515 (e.g., red for positive, green for negative, etc.). The light pipe is configured to both provide a color indication of the bottle status and to retain the culture bottle 230 in the drum receptacle 220. In this configuration, the culture bottle bottom 416 is secured to the receptacle by tabs 417.

[0054] FIG. 12A is a perspective view of a light pipe receptacle 515 with a light entry end 419 and a tab 417. The light pipe 515 is configured as a waveguide for an LED positioned at the light entry end. As such, the light pipe is configured to have total internal reflection, making it suitable as a waveguide. In one embodiment, the light pipe 515 has a refractive index of approximately 1.52, which is higher than the refractive index of the surrounding air. In one embodiment, the light pipe is coated, and the refractive index of the waveguide portion of the light pipe 515 is higher than the refractive index of the coating on the light pipe 515. FIG. 12B shows the light entry end 419, and FIG. 12C shows the tab 417.

[0055] For a light pipe to have the requisite total internal reflection, any curves must be gradual, with no sharp curves or blind spots. An example gradual bend is shown as 421 in FIG. 12A. In one embodiment, the light pipe has a body length of approximately 110 mm from the light entrance end 419 to the tab 417. For purity of transmission, it is advantageous if the presence of foreign matter and air bubbles is minimal. In one aspect, the light pipe is a molded polyacrylate. While the use of 3D printing to form the light pipe is contemplated, forming the light pipe by molding allows for easier quality control. In one aspect, the light pipe has very low, little, or near-zero internal absorption and is free of foreign matter and air bubbles. For example, and without limitation, low or little internal absorption is approximately 0.2 dBcm. -1 is less than.

[0056] Referring to FIG. 13, the bottles 230 (inward-facing) within the drum 240 are placed within one of six sectors (222A-222F) in the module 210. The sectors are bounded by vertical panels 221 extending outward from the drum 240. The distance between adjacent panels is approximately equal to the length of the door of the housing 224 to completely shield users from the interior of the module when accessing the culture bottle compartments. The module 210 also includes a blower and heater 225 to keep the bottles 230 warm. A status indicator panel 273 is located inside the drum. A drive motor assembly 270 is provided to rotate the drum 240. A measuring panel 545 is located outside the drum and performs pass-by measurements of the bottles and drum flags to determine bottle status and drum alignment, respectively.

[0057] 14, a receptacle is shown with a light pipe 515 through which light from the indicator LED 260 passes from the distal end 525 of the receptacle (i.e., the interior of the drum 240 in which the receptacle is disposed). The light pipe 515, if present, carries the bottle 230 and extends past the proximal end 420 of the receptacle (i.e., the exterior surface of the drum 240). A leaf spring 510 presses against the upper shoulder 535 of the culture bottle 230, keeping the bottle 230 against the tab 417. The receptacle 220 is adjacent to the bottle presence detector 250 at the distal end 525 of the receptacle 220. The distal end of the bottle 230 in the receptacle 220 is detected by the bottle presence detector 250. The bottle presence detector 250 is mounted to the status indicator panel 273. As shown in FIGS. 15A to 15E, the spring is embedded in the bottle holder 220.

[0058] The light pipe 515 is aligned with the indicator LEDs 260 on the status panel 273. The surface of the end of the light pipe 515 outside the bottle drum 240 is textured to disperse light from the indicator LEDs 260. When a bottle crimp cap 410 is placed in the receptacle 220, the bottle crimp cap 410 blocks a bottle presence detector 250 (e.g., an optical switch or proximity sensor). The indicator LEDs 260 and bottle presence detectors 536 are located on the status panel 273 positioned inside the drum 240 in an arrangement corresponding to each bottle 230 available to the user in the drum 240. The bottle presence detectors 250 are monitored while the door to the module is open to detect in real time when a bottle 230 is placed in or removed from the receptacle.

[0059] FIG. 15A shows a portion of a drum 240 with multiple vertical rows of receptacles 220. The drum is shown in cutaway view to show the culture bottles 230 supported within the receptacles 220. The top receptacle 220 is empty. In the embodiment shown in FIG. 15A, a pivot arm 551 is provided to secure the culture bottle 230 within the receptacle 220, instead of the previously described leaf spring 550. As the bottle 230 is advanced into the receptacle 230, the pivot arm 551 rotates clockwise, securing the culture bottle 230 in the receptacle. Resistance to the pivot arm 551 is provided by a coil spring 552 secured within the receptacle by a pin 556.

[0060] An alternative form of the receptacle shown in FIG. 15A is shown in FIGS. 15B through 15E. Referring to FIG. 15B, the pivot arm 551 shown in FIG. 15A has been replaced with a deformable material 553. In one example, the deformable material 553 is peristaltic tubing, although other conventional deformable materials are contemplated. An important aspect of the deformable material is its resilience, provided that its shape does not change after each instance of deformation due to the insertion of a culture bottle into the receptacle. The bottom of the receptacle 220 is a light pipe 515.

[0061] The deformable material 553 is located in the tapered portion 554 of the receptacle 220. Referring to Figure 15C, an end view of the receptacle (220) shows the deformable material 553 at the top of the receptacle (along the tapered portion 554 of the receptacle). Suitable deformable materials include elastomeric and foam materials, in addition to the elastomeric peristaltic tubing described above.

[0062] FIG. 15D is a perspective view of one receptacle 220 with a portion of a second receptacle formed on it. A culture bottle is held in the receptacle as described above. Tabs 417 hold the culture bottle 230 in the receptacle 220. Other materials for the deformable material are contemplated as having sufficient frictional properties when used in contact with the bottle 230. Such friction prevents the bottle 230 from rotating, thereby enabling the measurement system to obtain a high-quality signal with less noise caused by bottle vibration due to rack movement. FIG. 15E is a top view of a culture bottle held in the receptacle 220 with a light pipe 515.

[0063] In one embodiment, the modular cabinet in which the drum rack is placed has a heat distribution system made of lightweight, molded expanded polypropylene (EPP) foam. This is referred to herein as a molded foam heat distribution assembly. While EPP foam is described herein, other moldable synthetic materials, such as expanded polystyrene (EPS), are contemplated. EPP foam is more resilient and less brittle than EPS, making it more suitable for applications where the foam may be subjected to operational stress. Those skilled in the art can select an appropriate molded foam for the molded foam heat distribution assembly described herein.

[0064] The molded foam heat distribution assembly can be customized, which is an advantage when it is desired to provide a relatively uniform (i.e., relatively temperature gradient-free) heated air environment. The customized heated environment can be adjusted to ensure that bottles in the rack do not have different temperatures and that the ambient temperature (cabinet temperature) and the actual temperature of individual bottles in the rack are essentially uniform (with an acceptable tolerance of approximately ±5 percent). That is, the ambient temperature (cabinet temperature) within the cabinet should not vary by more than approximately ±5 percent anywhere within the cabinet, and the temperature of individual bottles in the rack (at equilibrium within the heated cabinet) should not vary by more than approximately ±5 percent. For example, if the target ambient temperature for an incubator is 36.5°C and the ambient temperature can vary by ±1°C, then the tolerance for warming one or more fully loaded drum racks (e.g., 240 bottles) is ±2.7%. Because it takes time for ambient heat to raise the bottle temperature to ambient temperature, there will be a greater variability between ambient temperature and bottle temperature.

[0065] In a further embodiment, one or more heater / blower units (one unit per cabinet) have a motor-driven blower that blows a sufficient volume of air through a heater (e.g., a 250-watt heater) and distributes the hot air through an outlet opening onto the rotating drum rack (with the culture bottles inside). The hot air is directed to different rows of the rotating drum rack by multiple ducts formed in the molded EPP foam insert. The heater / blower units are assembled into a two-cabinet system, with one unit located below the rotating drum rack in the lower cabinet and the other unit located above the rotating drum rack in the upper cabinet. This arrangement is shown in FIG. 18 and described in detail herein below. In one embodiment, the heater / blower units are mounted on rails for easy maintenance. The units are held in place by leaf springs that hold them in place. As shown below in FIGS. 18-20, in one embodiment, there are five ducts 1221 molded into the side insert 1220A. Duct 1221 motors more targeted airflow, resulting in more-or-less uniform exposure of all bottles in the rack to the blown heated air. By blowing the heated air through this air distribution system, a relatively uniform temperature distribution is provided throughout the cabinet in which the rotating drum rack is located. In particular, the ducts motor more uniform air distribution, and the blowers motor circulating air that similarly distributes the heated air throughout the cabinet, ensuring more uniform heating of the bottles contained in the rotating drum rack.

[0066] In one optional aspect, the foam molded insert heat distribution assembly can have additional ducts, such as a duct on the back of the foam molded insert heat distribution assembly. Rear duct 1223 is shown in Figure 24, which is a top view of the foam molded insert heat distribution system on top component 1220C.

[0067] In one embodiment, the motor for the heater / blower unit is a DC-input centrifugal blower. Such a blower is suitably compact in design and has a sufficiently small exhaust to cooperate with the molded foam insert heat distribution assembly to provide adequate airflow within the assembly. The blower itself is located within the molded foam insert heat distribution assembly in one embodiment. The heater and RTD may also be housed within the molded foam insert heat distribution assembly in a chamber with an outlet opening in fluid communication with the air duct inlet of the molded foam insert heat distribution assembly. To mitigate heat and air loss, the molded foam insert heat distribution assembly is fastened together in a conventional manner. In one embodiment, the molded foam panels forming the assembly are fastened together and to the module frame using snap fits and sheet metal clamshells. The clamshells are fastened together using, for example, screws. In addition to providing insulation to the interior of the module, the molded foam insert heat distribution assembly reduces sound emanating from the module and damps vibrations from both the interior and exterior of the module.

[0068] With the addition of a foam molded insert heat distribution assembly to provide ducts for circulating heated air past the drums, the assembly is formed behind the frame that receives the drum rack. FIG. 17 shows a module 1210 according to one embodiment of an apparatus for incubating, storing, and monitoring blood culture bottles described herein. Module 1210 has two cabinets 1211, each for receiving a drum rack 1240, described elsewhere herein. As shown in FIG. 17, cabinet 1211A does not have a drum rack placed therein (but can receive one), while cabinet 1211B has a drum rack 1240 therein. When module 1210 is in operation, a drum rack 1240 resides within each cabinet. Module 1210 is shown alongside another module 1212. Module 1212 has a touch screen 1203 and an input / output rack 1204 for receiving culture bottles into module 1212 from which the culture bottles are loaded into module 1210. Module 1212 is described in U.S. Provisional Patent Application No. 63 / 390,535, filed July 19, 2022, which is incorporated herein by reference.

[0069] The compartment 1211A has therein a foam insert heat distribution assembly 1220. The foam insert heat distribution assembly 1220 is formed from molded side duct sections 1220A and a recessed middle section 1220B. The recessed middle section 1220B is shaped to accommodate the curvature of the drum rack 1240 and to allow the air duct 1221 to be as close to the drum rack 1240 as possible without interfering with the rotation of the drum.

[0070] FIG. 18 is a diagram of a molded foam insert heat distribution assembly in communication with heater / blower assemblies 1245A / 1245B for module 1210, without other module components. In the case of a two-cabinet module, there is a molded foam insert heat distribution assembly 1220A for cabinet 1211A and a molded foam insert heat distribution assembly 1220B for cabinet 1211B. Each molded foam insert heat distribution assembly is in fluid communication with heater / blower assemblies 1245A and 1245B, respectively. Referring to FIGS. 18-20, the two-cabinet configuration has heater / blower 1245A and molded foam insert heat distribution assembly 1220A as the upper cabinet and heater / blower 1245B and molded foam insert heat distribution assembly 1220B as the lower cabinet. Their orientations are different, with heater / blower assembly 1245B in an upside-down orientation compared to the orientation of heater / blower assembly 1245A. 20, it can be seen that the foam molded insert heat distribution assembly 1220B is a mirror image of the foam molded insert heat distribution system 1220A. Although received in a different orientation in the module, the components are interchangeable. This allows for ease and efficiency in manufacturing since the components are similar.

[0071] Referring to FIG. 25, the frame 1250 of the module 1210 is shown without the rotating drum rack placed therein. The molded foam insert heat distribution assemblies 1220A and 1220B are located at the rear of the compartments 1211A and 1211B. Also shown in FIGS. 25 and 22 is the housing 1260 into which the heater / blower assembly 1245A is received (only the upper heater / blower assembly is visible in FIGS. 25 and 22). The lower heater / blower assembly 1245B is shown in FIGS. 21 and 23. A long handle 1270 is provided that extends to the front of the frame 1250 to provide access to the heater / blower assembly 1245. Rails 1280 are provided so that the heater / blower assemblies 1245A / 1245B can be easily pulled out of the housing 1260 using the handle 1270 for maintenance. Referring to Figure 22, housing 1260 is shown in perspective so that heater / blower assembly 1245A can be seen through it. Heater / blower assembly 1245A is held within housing 1260 by spring clip 1290. Handle 1270 is moved forward to advance heater / blower assembly 1245A out of housing 1260 for maintenance. Handle 1270 is secured onto the frame by screw 1275. Figure 23 shows heater / blower assembly 1245B and handle 1270, which is used to pull heater / blower assembly 1245B out of its housing.

[0072] The molded foam insert heat distribution assemblies 1220A and 1220B offer several advantages. In particular, they can be assembled and placed into modules with minimal additional components, such as sheet metal and fasteners, used in more traditional heat distribution systems. In one embodiment, the molded foam insert heat distribution system is an assembly of five molded foam pieces. These are three components 1220A, 1220B, and 1220C shown in FIG. 19, which, along with upper component 1220C ( FIG. 24 ) and lower component 1220D ( FIG. 21 ), form an integral air duct. As shown in FIG. 19 , component 1220A has tabs 1225 that are received by notches 1230 in component 1220B. This allows component 1220A to be assembled to component 1220B by inserting tabs 1225 into notches 1230. An air distribution system formed from molded foam provides less turbulent airflow. Because the foam molded inserts fit together, the assembly is easier to put together and less prone to assembly errors. In a further embodiment, the duct 1221 is tapered to improve air flow. A tapered duct 1221 is shown in Figures 19 and 20. In addition to the tapered duct 1221, the foam molded heat distribution assembly has smaller ducts / vents to provide more heated air flow paths that can be directed toward more bottles contained in the rack 1240.

[0073] In one embodiment, module 1210 has a foam molded insert heat distribution assembly that can be assembled by simply joining the pieces together. In one embodiment, the individual molded components can have protrusions in the groove features to facilitate assembly. In one embodiment, five pieces are assembled to form one foam molded insert heat distribution assembly. Crush ribs (which allow larger objects to fit into smaller openings), Christmas tree fasteners, etc. can be used to further enhance ease of installation. Those skilled in the art will be familiar with suitable fasteners that can be used to assemble foam molded insert heat distribution assemblies together, and such fasteners will not be described in detail herein. The foam molded insert heat distribution assembly is fluidly connected to heater / blower units 1245A / 1245B as described herein.

[0074] The heater / blower units 1245A / 1245B, in one embodiment, have a lightweight design. Features such as handles, side rails, and leaf springs allow the heater / blower units to be easily inserted into the module, securely gripped, and easily removed. The leaf springs also secure the heater / blower units so that hot air leakage between the blower and the molded foam insert heat distribution assembly is mitigated. The handle 1270 can also be used to tether / secure the cable 1295 to the heater / blower 1245.

[0075] The foam molded insert heat distribution assembly allows for targeted airflow distribution as described above.

[0076] As described herein, the module rotates the drum to position the bottles for both user and automated use. The module also rotates the culture bottles to agitate them.

[0077] The device described herein provides the following advantages: 1) noise reduction (i.e., the ratio of growth signal to reference signal should not be affected by bottle position, temperature, and sensor variations); 2) detection of growth in vials that experience delays in input to the system (i.e., the dual measurements described above provide a reference during growth such that the contents of the vial do not need to be sampled continuously to confirm a positive result by detecting accelerated growth); and 3) signal quality indicator (i.e., the reference signal is an independent indicator of the health of the station hardware).

[0078] Described herein is an apparatus for storing and monitoring blood culture bottles. The apparatus has a frame defining at least one cabinet. The cabinet can receive a drum-shaped rack therein, the rack having an outer periphery and an inner periphery. The outer periphery has a diameter greater than the diameter of the inner periphery. The drum has a plurality of receptacles, the receptacles having a proximal end at the outer periphery and a distal end at the inner periphery. Each receptacle can receive one blood culture bottle, the bottle having a base and a neck. The bottle can be received by the receptacle either with the base received in the distal end of the receptacle or with the neck received in the distal end of the receptacle. In one embodiment, the drum periphery is disposed about an axis of rotation of the drum.

[0079] The receptacles are arranged on the drum as an array of receptacles, the array having receptacles arranged both vertically and horizontally. The vertically aligned receptacles may form columns. The horizontally aligned receptacles may form rows.

[0080] Each cabinet can have a molded foam insert heat distribution assembly therein. In one embodiment, the molded foam insert assemblies can be combined molded foam inserts. Each molded foam insert heat distribution assembly can be in fluid communication with a heater / blower assembly. In one embodiment, the frame is disposed within the housing.

[0081] In one embodiment, the cabinet in the device has two molded foam side inserts assembled to a molded foam center insert. In a further embodiment, the molded foam side inserts are assembled to the molded foam center insert to define a plurality of ducts.

[0082] In a further embodiment, the heater / blower assembly is in fluid communication with the duct. In a further embodiment, the duct outlet is directed toward one receptacle in the drum-type rack. In a further embodiment, the heater / blower assembly is supported by a frame either above the cabinet in which the molded foam insert heat distribution is located or below the cabinet in which the molded foam insert heat distribution is located. In a further embodiment, the heater / blower assembly is located within a housing.

[0083] In a further aspect, the frame includes handles and rails for inserting and ejecting the heater / blower assembly into and from the housing.

[0084] In another aspect, described herein is an apparatus for storing and monitoring blood culture bottles. The apparatus may have a drum-shaped rack having an outer periphery and an inner periphery. The outer periphery has a diameter greater than the diameter of the inner periphery. The drum has a plurality of receptacles, each having a proximal end at the outer periphery and a distal end at the inner periphery. Each receptacle is configured to receive one blood culture bottle. In one aspect, the blood culture bottle has a base and a neck. The bottle is receivable in the receptacle either with the base or the neck received in the distal end of the receptacle. In a further aspect, the drum periphery is disposed about an axis of rotation of the drum, and the drive motor may be positioned within the inner periphery of the drum and coincident with the axis of rotation. In a further aspect, the apparatus may have a drum motor encoder rigidly coupled to the shaft of the motor shaft of the drive motor.

[0085] The device may have an alignment sensor adapted to detect a condition when the drum's axis of rotation is not a vertical axis. In a further aspect, the device may have a bottle presence sensor that detects the presence of a bottle in a receptacle. The bottle presence sensor may be adapted to detect drum alignment and drum misalignment. A misalignment condition may be detected when a bottle presence sensor fails to detect a bottle and a bottle is known to currently be in the receptacle opposite the failing sensor. In a further aspect, the drum motor encoder may provide feedback to the operator when the operator is manually moving the drum rack. The drum motor encoder increments manual movement of the drum rack, and manual rotation advances the drum track a predetermined rotational angle.

[0086] Described herein is an apparatus for storing and monitoring blood culture bottles, the apparatus having a frame defining at least one cabinet, the cabinet adapted to receive a drum-shaped rack having an outer periphery and an inner periphery, the outer periphery having a diameter greater than that of the inner periphery, the drum having a plurality of receptacles, the receptacles having a proximal end at the outer periphery and a distal end at the inner periphery, each receptacle configured to receive one blood culture bottle, the blood culture bottles including a base and a neck, the bottles receivable in the receptacle either by the base being received in the distal end of the receptacle or by the neck being received in the distal end of the receptacle, the drum periphery being disposed about an axis of rotation of the drum. The receptacles are arranged on the drum as an array of receptacles, the array having receptacles arranged both vertically and horizontally, with the vertically aligned receptacles forming columns and the horizontally aligned receptacles forming rows. The apparatus also has a foam molded insert heat distribution assembly in each cabinet, the foam molded insert assembly including a plurality of interlocking foam molded inserts. Each foam molded insert heat distribution assembly is in fluid communication with a heater / blower assembly. A frame is disposed within the housing.

[0087] In this apparatus, two foam molded side inserts are assembled to a foam molded center insert. In one embodiment, the foam molded side inserts, when assembled to the foam molded center insert, define a plurality of ducts. In a further embodiment, a heater / blower assembly is in fluid communication with the ducts. In one embodiment, the duct outlet is directed toward a single receptacle in the drum-type rack. In a further embodiment, the heater / blower assembly is supported by a frame either above the cabinet in which the foam molded insert heat distribution is located or below the cabinet in which the foam molded insert heat distribution is located. In a further embodiment, the heater / blower assembly is located within a housing. In a further embodiment, the frame includes a handle and rails for advancing and removing the heater / blower assembly into and from the housing.

[0088] Described herein is an apparatus for storing and monitoring blood culture bottles. The apparatus includes a drum-shaped rack having an outer periphery and an inner periphery, the outer periphery having a diameter greater than the diameter of the inner periphery. The drum includes a plurality of receptacles, each receptacle having a proximal end at the outer periphery and a distal end at the inner periphery, each receptacle configured to receive one blood culture bottle, the blood culture bottle including a base and a neck, the bottle being receivable in the receptacle either by the base being received in the distal end of the receptacle or by the neck being received in the distal end of the receptacle. In the above-described apparatus, the drum periphery is disposed about the drum's axis of rotation. In a further aspect, a drive motor may be positioned within the inner periphery of the drum, coincident with the axis of rotation. The apparatus also includes a drum motor encoder rigidly coupled to the motor shaft of the drive motor.

[0089] In one embodiment of the above-described device, the device has an alignment sensor adapted to detect a state in which the drum's rotation axis is not vertical. The device further includes a bottle presence sensor that detects the presence of a bottle in a receptacle. The bottle presence sensor is adapted to detect drum alignment and drum misalignment. In one embodiment, a misalignment is detected when a bottle presence sensor fails to detect a bottle and a bottle is known to currently be present in the receptacle opposite the failing sensor. In the above-described device, the drum motor encoder provides feedback to an operator when the operator is manually moving the drum rack. In a further embodiment, the drum motor encoder increments manual movement of the drum rack, and manual rotation advances the drum track a predetermined rotation angle. In one embodiment, the above-described drum-type rack is vertically movable relative to the drive motor. The drum-type rack may have a lifting device for raising the drum relative to the motor. The drum-type racks described herein may have a locking device for supporting the drum-type rack on a frame on which the drum-type rack is disposed when the drum is in a raised position. The above-described devices may have a measuring plate that includes sensors for determining the status of the blood culture bottles as the drum-type rack is moved past the measuring plate. As described throughout, the measuring plate may be positioned adjacent the periphery of the drum-type rack.

[0090] The above-mentioned device with a locking tool may have a locking tool with a handle and a bracket. In the above-mentioned device, the lifting device may have a motor assembly support plate and a screw that advances through a guide nut. The above-mentioned device operates such that the screw urges the plate upward when the drum-shaped rack is advanced upward. In the above-mentioned embodiment, the plate moves upward along the guide pin. In this embodiment, as the plate moves upward, the drum-shaped rack is raised from the drum support, thereby creating a lifting space between the frame and the rotor of the drive motor.

[0091] In this specification, the word "comprising" is to be understood in its "open" sense, i.e., "including," and not limited to its "closed" sense, i.e., "consisting only of." A corresponding meaning is to be ascribed to the corresponding words "comprise," "comprises," and "comprised," where they appear.

[0092] While specific embodiments of the present technology have been described, it will be apparent to those skilled in the art that the present technology may be embodied in other specific forms without departing from its essential characteristics. The present embodiments and examples are, therefore, to be considered in all respects as illustrative and not restrictive.

[0093] It will be further understood that any reference herein to subject matter known in the art does not constitute an admission that such subject matter is generally known by those skilled in the art to which this technology pertains, unless otherwise indicated.

Claims

1. 1. A device for storing and monitoring blood culture bottles, comprising: a frame defining at least one cabinet, the cabinet adapted to receive a drum-shaped rack having an outer periphery and an inner periphery, the outer periphery having a diameter greater than a diameter of the inner periphery, the drum having a plurality of receptacles, the receptacles having a proximal end at the outer periphery and a distal end at the inner periphery, each receptacle configured to receive one blood culture bottle, the blood culture bottle including a base and a neck, receivable in the receptacle either with the base received in the distal end of the receptacle or the neck received in the distal end of the receptacle; The drum periphery is disposed around the rotation axis of the drum, the plurality of receptacles are arranged on the drum as an array of receptacles, the array having receptacles arranged both vertically and horizontally, with vertically aligned receptacles forming columns and horizontally aligned receptacles forming rows; a molded foam insert heat distribution assembly within the cabinet, the molded foam insert heat distribution assembly including a plurality of interlocked molded foam inserts; the foam molded insert heat distribution assembly is in fluid communication with a heater / blower assembly; The apparatus wherein the frame is disposed within a housing.

2. 10. The apparatus of claim 1, wherein two foam molded side inserts are assembled to a foam molded center insert.

3. The apparatus of claim 2 , wherein the foam molded side inserts define a plurality of ducts when assembled to the foam molded center insert.

4. The apparatus of any one of claims 1 to 3, wherein the heater / blower assembly is in fluid communication with the duct.

5. 5. The apparatus of claim 1, wherein the duct outlet is directed towards one receptacle in the drum-shaped rack.

6. 5. The apparatus of claim 1, wherein the heater / blower assembly is supported on the frame either above the cabinet in which the foam molded insert heat distribution assembly is placed or below the cabinet in which the foam molded insert heat distribution assembly is placed.

7. The apparatus of any one of claims 1 to 6, wherein the heater / blower assembly is located within a housing.

8. The apparatus of any one of claims 1 to 7, wherein the frame includes handles and rails for inserting and removing the heater / blower assembly into and from the housing.

9. 1. A device for storing and monitoring blood culture bottles, comprising: a drum-shaped rack having an outer periphery and an inner periphery, the outer periphery having a diameter greater than a diameter of the inner periphery, the drum having a plurality of receptacles, the receptacles having a proximal end at the outer periphery and a distal end at the inner periphery, each receptacle configured to receive one blood culture bottle, the blood culture bottle including a base and a neck, receivable in the receptacle either with the base received in the distal end of the receptacle or with the neck received in the distal end of the receptacle; The drum periphery is disposed around the rotation axis of the drum, a drive motor disposed within the inner periphery of the drum-shaped rack and aligned with the axis of rotation; The apparatus includes a drum motor encoder rigidly coupled to a motor shaft of the drive motor.

10. 10. The apparatus of claim 9, further comprising an alignment sensor adapted to detect a condition in which the axis of rotation of the drum is not a vertical axis.

11. 11. The device of claim 9 or 10, further comprising a bottle presence sensor for detecting the presence of a bottle in the receptacle.

12. An apparatus according to any one of claims 9 to 11, wherein the bottle presence sensor is adapted to detect alignment of the drum and misalignment of the drum.

13. 13. The apparatus of any one of claims 9 to 12, wherein a misalignment condition is detected when the bottle presence sensor fails to detect a bottle known to be currently in a receptacle opposite the non-detection sensor.

14. 14. The apparatus of any one of claims 9 to 13, wherein the drum motor encoder provides feedback to an operator when the operator is manually moving the drum rack.

15. 15. The apparatus of any one of claims 9 to 14, wherein the drum motor encoder increments manual movement of the drum rack such that manual rotation advances the drum rack by a predetermined rotation angle.

16. The apparatus according to any one of claims 9 to 15, wherein the drum-shaped rack is vertically movable relative to the drive motor.

17. 17. Apparatus according to any one of claims 9 to 16, wherein the drum-shaped rack includes a lifting device for raising the drum relative to the motor.

18. 18. Apparatus according to any one of claims 9 to 17, comprising locking means for supporting the drum-shaped rack on a frame on which it is arranged when the drum is in a raised position.

19. 19. The apparatus of claim 9, further comprising a measuring board including a sensor for determining the status of the blood culture bottles as the drum-shaped rack is moved past the measuring board.

20. 20. The apparatus of any one of claims 9 to 19, wherein the measuring plate is positionable adjacent the outer periphery of the drum-shaped rack.

21. The device according to any one of claims 18 to 20, wherein the locking device comprises a handle and a bracket.

22. An apparatus according to any one of claims 17 to 21, wherein the lifting device includes a screw that passes through a motor assembly support plate and a guide nut.

23. 23. The device of any one of claims 17 to 22, wherein when advanced upwardly, the screw urges the plate upwardly.

24. 24. The apparatus of claim 23, wherein the plate moves upwardly along a guide pin.

25. 25. The apparatus of claim 24, wherein when the plate moves upward, the drum-shaped rack is raised from a drum support, thereby creating a lift space between the frame and the rotor of the drive motor.

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