Barrel-shaped container holder for blood culture bottle and methods of measurement and operation

Abstract

An apparatus for storing and monitoring blood culture flasks. The apparatus has a movable support configured as a drum having a plurality of receptacles therein for receiving blood culture flasks. The drum is disposed in the housing. The housing includes a heater and a blower for incubating the blood culture bottle at an elevated temperature. The receptacle has a light tube to provide an indication of the bottle status determined by the apparatus. The apparatus has a housing having a plurality of 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 fixed to a motor placed in the center of a movable support in the shape of a drum. A motor encoder detects whether the drum-shaped bracket is in alignment or misalignment and increments manual or automatic rotation of the drum-shaped bracket.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 432,460, filed December 14, 2022, and this application also claims the benefit of and is related to U.S. Provisional 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 No. PCT / US2020 / 045065, filed August 5, 2020, which is incorporated herein by reference. Technical Field

[0003] The present invention relates to a non-invasive device for detecting biological activity in samples such as blood, in which a number of samples are introduced into a large number of sealable containers along with culture media and exposed to conditions that enable various metabolic, physical and chemical changes to occur in the presence of microorganisms in the samples. These changes are then monitored using calorimetric or fluorescent chemical sensors placed on the inner bottom of each blood culture bottle as the bottles are rotated in a rotatable drum. After monitoring is complete, the device performs "automatic unloading" and sorting of final negative bottles and final positive bottles. Background Art

[0004] The presence of bioactive agents such as (bacteria) in a patient's body fluids, especially blood, is generally determined using blood culture bottles. A small amount of blood is injected through a closed rubber septum into a sterile bottle containing culture medium, and the bottle is then incubated at approximately 35°C and monitored for microbial growth.

[0005] Since it is most important to know whether a patient has a bacterial infection, hospitals and laboratories have automated equipment that can process many blood culture bottles at the same time. An example of such equipment is the BD BACTEC manufactured and sold by Becton, Dickinson and Co. TM System. U.S. Patent No. 5,817,508 to Berndt et al. describes a prior art blood culture apparatus and is incorporated herein by reference. Additional descriptions of blood culture apparatus are 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.

[0006] 1 , a culture medium and blood sample mixture 22 is introduced into a sealable glass bottle 1, which includes an optical chemical sensing device 20 on its inner bottom surface 21. The optical chemical sensing device 20 emits different amounts of light depending on the amount of gas in the bottle 1. For example, the gas being detected by the optical sensing device 20 may be carbon dioxide, oxygen, or any gas that increases or decreases depending on the presence or absence of microbial growth in the bottle 1.

[0007] As illustrated in Figures 1 and 2, a plurality of such bottles 1 are radially arranged on a rotating bell drum 2 within an incubator 5 in such a manner that the bottom of the bottles 1 are oriented toward the drum axis 28. The bell drum 2 is hollow and supported by a shaft 24, which is rotatably supported on one end by two large ball bearings 3 and 4, which are mounted to a first side 51 of the instrument main frame 50. In order to read the information from each optical chemical sensing device 20 within the bottle 1, a linear array of sensor stations 12 is mounted to a second side 52 of the instrument main frame 50 within the rotating bell drum 2, at a distance inside the bell drum 2 such that during the rotation of the drum 2, each bottle 1 passes by a corresponding sensor station 15 in the array 12. Each sensor station 15 of the linear array of sensor stations 12 includes an excitation light source 11 and a collecting end of an optical fiber 14.

[0008] The axis 28 of the bell drum 2 is oriented horizontally and parallel to the door 13 shown in FIG. 2 on the front face of the incubator 5. The horizontal orientation of the axis 28 provides maximum agitation of the liquid culture medium and sample mixture 22 and the gas within each bottle 1. During the loading or unloading operation, the door 13 is opened, which allows about one third of all bottles 1 to be accessed at the same time. Then, the drum 2 is rotated until the next third of bottles 1 become accessible. In three steps, all bottles 1 are accessible.

[0009] Alternatively, the axis 28 of the bell drum 2 is oriented vertically at a slight inclination of about 20 degrees away from the door 13. By adjusting the angle of inclination, the degree of agitation can be modified, if necessary, in order to maintain optimal growing conditions.

[0010] In operation, the bell drum 2 is rotated by the motor 6 and belt 7. The circular member 8 and the sensor 9 form an angle encoder which provides information about which row of bottles 1 is passing the array of sensor stations 12. Preferably, the motor 6 is a stepper motor, allowing the drum 2 to rotate in a continuous mode or to stop the drum 2 at the appropriate angle in a steady-state mode to read from the sensing devices 20 inside the bottles 1. The entire system is controlled by a control system 10 located inside the rotating drum 2. The output ends of all the optical fibers 14 of the linear array of sensor stations 12 are fed to one 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. Therefore, the control system "knows" from which sensing station 15 the sensor light is being collected, and therefore from which bottle 1 the sensor light is being collected.

[0011] The device shown in Figures 1 and 2 contains ten sections of blood culture bottles 1 with thirty-six bottles 1 per section. The total capacity is therefore 360 ​​bottles. The arrangement of the bottles 1 on the drum 2 allows a relatively high packing density, but improvements in density are still sought. Summary of the invention

[0012] A device for storing and monitoring blood culture bottles is described herein. The device has a removable support configured as a drum having a plurality of receptacles therein for receiving blood culture bottles. The drum is disposed in a housing. The housing includes a heater and a blower for incubating 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 device has a plurality of drums, each having a plurality of receptacles for receiving blood culture bottles.

[0013] An apparatus for storing and monitoring blood culture bottles is described herein, the apparatus having a drum-shaped support having an outer periphery and an inner periphery, the outer periphery having a diameter that exceeds the diameter of the inner periphery, the drum having a 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 section and a neck section. The bottle is receivable by the receptacle such that the bottom is received at the distal end of the receptacle, or the neck is received at the distal end of the receptacle. In one aspect, the drum periphery is arranged around an axis of rotation of the drum. In any of the above aspects, the plurality of receptacles are arranged in the drum in an array of receptacles, the array having receptacles arranged vertically and horizontally, the vertically aligned receptacles forming columns, and the horizontally aligned receptacles forming rows. The apparatus may also have a bottle status indicator plate removably attached to the inner periphery of the drum-shaped support, the bottle status indicator plate having a plurality of bottle presence sensors and a plurality of bottle status indicator lights forming an array, the array being configured so that the bottle presence sensors are aligned with the receptacles so that the presence or absence of a bottle can be detected by the bottle presence sensors. The status indicator lights are positioned opposite to a light pipe associated with the receptacle so that the light pipe is illuminated by the status indicator lights to indicate the status of the bottle in the receptacle. The status reflects whether the receptacle contains a blood culture bottle that is positive or negative for microbial growth therein. In one aspect, the drum defines an interior space within the inner periphery, wherein at least a portion of the drum electronics that communicate with sensors and detectors for interrogating the blood culture bottles is disposed in the inner periphery of the drum.

[0014] In another aspect, a motor is positioned within the inner perimeter of the drum-shaped support. In another aspect, the drum-shaped support can have a plurality of sections, each section of the drum-shaped support having a plurality of columns and rows of receptacles, wherein at least one section is removable from a frame of the drum-shaped support. In another aspect, the bottle status indicator plate is removably coupled to the frame behind a section. In addition, the number of rows of the bottle presence sensors and the number of rows of the bottle status indicator lights in the bottle status indicator plate correspond to the number of rows of the receptacles in the section of the drum-shaped support.

[0015] In another aspect, the roller is vertically movable relative to the motor. In this aspect, the roller has a lifter for raising the roller relative to the motor. The device may also have a locking tool for supporting the roller on the frame when the roller is in a raised position. In any of the above aspects, the device also includes a measurement board, the measurement board including a sensor for determining the state of the bottle when the container moves through the measurement board. In such an aspect, the state of the bottle is one of positive for microbial growth or negative for microbial growth. In such an aspect, the measurement board can be placed near the outer periphery of the roller-shaped support. In such an aspect, the measurement board can have an alignment sensor. An example of an alignment sensor is a magnetic proximity sensor (also known as a Hall effect sensor) placed near the measurement board or incorporated as a component of a circuit board. Such a sensor will detect a magnet attached to the roller near the first column of bottles, commonly referred to as a home position. Second, another example of an alignment sensor can be an optical detector. In another aspect, the alignment sensor is configured to detect a mark positioned on a panel defining each section of the roller-shaped support. In one aspect, the mark is a flange extending from the panel that will pass through the optical detector's beam. An interruption of the detector's beam indicates that the mark has passed through the optical detector. In another example, alignment of the drum to the status indicator plate is accomplished by monitoring the reading from the optical sensor on the status indicator plate itself, which may be programmable and provide a digital readout of proximity to an object. This digital readout may be used to sense the edge of the bottle array station, which when correlated with the drum motor encoder value forms the basis for a drum to status indicator plate auto-alignment feature.

[0016] In one aspect, the marks are alignment marks and section marks. Each section of the drum-shaped support has a different distribution of marks. In one aspect, when the alignment marks interrupt the light beams in multiple alignment sensors, alignment is indicated. In another aspect, when alignment is indicated, the section of the drum-shaped support is determined. In one aspect, the pattern of the detected section marks indicates that the drum section is aligned with the door of the housing for the drum-shaped support. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] FIG1 shows a front view of the interior of a blood culture device for detecting microorganisms of the prior art;

[0018] FIG2 shows a side view of the interior of a prior art blood culture apparatus;

[0019] Figure 3A and Figure 3B illustrates a perspective view of a blood culture apparatus housing for use with the modules described herein;

[0020] Figure 4 is a top view of an incubation and measurement module according to one embodiment of the present invention;

[0021] Figure 5A-Figure 5C A bottle holder drum is illustrated in side view and partial top view with and without a section removed to expose the BDSI plate;

[0022] Figure 6A-6E The diagram shows the lifting mechanism for servicing the motor inside the drum;

[0023] Figure 7A-7E illustrates the BDSI board and the measurement board and controller board connections forming part of the measurement board, and alignment marks and segment identifier sensor marks working with the alignment sensors and segment identifier sensors on the controller board;

[0024] Figure 8 illustrates the configuration of the alignment marks and the section identifier marks that indicate to the BDSI board which drum section is aligned with the door of the drum module;

[0025] Fig. 9 illustrates one example of the progression of the drum / bottle status panel light pattern used to guide the user in aligning the drum with the BDSI plate;

[0026] Fig. 10A - Figure 10J illustrates aspects of a light source and detector for bottle interrogation;

[0027] Fig.11 is the drum shown in FIG. 5 having a transparent internal reflective light tube forming a receptacle for receiving a blood culture bottle;

[0028] Figure 12A-12C The diagram shows Fig.11 The light tube used in the drum;

[0029] Fig.13 illustrates a top view of a bottle drum described herein;

[0030] Fig.14 illustrates a bottle in a receptacle with a light pipe;

[0031] Figure 15A-15E A bottle is illustrated held in a receptacle having a light pipe;

[0032] Fig.16 illustrates one aspect of a roller described herein, which illustrates the incremental degrees that the roller may be advanced to achieve alignment of one rack row of bottles with a bottle sensor;

[0033] Fig.17is an open front view of a blood culture incubation module according to one aspect of the apparatus described herein, the blood culture incubation module being adjacent to a module for loading and unloading blood culture bottles from the blood culture incubation module;

[0034] Fig.18 is a view of a heater / blower assembly and molded foam insert heat distribution system according to one aspect of the present invention;

[0035] Fig.19 yes Fig.18 An exploded view of the molded foam insert heat distribution system;

[0036] Fig. 20 yes Fig.18 A side cross-sectional view of a heater / blower assembly and a molded foam insert heat distribution system;

[0037] Fig.21 yes Fig.18 A front view of the heater / blower assembly;

[0038] Fig. 22 According to one aspect of the present invention Fig.18 The upper heater / blower assembly is placed in Fig.17 A perspective view of a blood culture module in a cabinet;

[0039] Fig.23 According to one aspect of the present invention Fig.18 The lower heater / blower assembly is located in Fig.17 A perspective view of a blood culture module in a cabinet;

[0040] Fig.24 is a top view of a molded foam insert heat distribution system; and

[0041] Fig.25 is a perspective view of the frame of a blood culture module in which a heat distributing molded foam insert is placed. DETAILED DESCRIPTION

[0042] Described herein is a blood culture device configured as an incubation and measurement module that 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 in a device such as a Figure 3A and Figure 3B The cabinet 200 can provide power to the modules, provide a controlled thermal environment for the modules, and provide communication channels for the modules. Figure 3AThe cabinet 200 is illustrated with two three-door panels 201 providing access to three bottle drums on each side of a center panel 202. The center panel 202 has a touch screen 203 for data entry and usage control. The center panel 202 also has a central station 204 for culture bottle input / output. Figure 3B A cabinet is illustrated with only one three-door panel 201. Figure 3C illustrates a cabinet 200 with two double door panels, and Figure 3D illustrates a cabinet with only one double door panel.

[0043] The number of doors will depend on the number of rollers. The number of roller supports in a module is largely a matter of design choice, with single-roller, double-roller and triple-roller configurations contemplated herein. The apparatus described herein is not limited to any particular number of rollers.

[0044] The module has a high-density bottle drum. As used herein, high density is a description of a drum configuration that allows culture bottles to be placed closer to each other to allow a larger number of bottles to be fitted into the drum compared to the prior art. The module is configured to align the bottle 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 that can cause acceleration and deceleration of the drum movement (i.e., shaking movement, intermittent rotation, etc.). The heater and blower are provided in the drum shell, or in the space above or below the part of the shell where the drum is received. The heater and blower circulate warm air around the drum. Optionally, the heater and blower will be configured to keep 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°C to 40°C. Optionally, the target temperature is 36.55°C. Greater temperature uniformity will allow an increase in the set point because there is a smaller risk of "overheating" the sample. Greater temperature uniformity at higher temperatures will therefore allow faster detection times. The motor will allow the drum to be positioned so that a user or automated equipment can pick up and place any bottle carried by the drum. When the sample in the bottle is determined to be positive for microbial growth, the workflow is activated to retrieve the culture bottle from the module. The module is configured to assist in this workflow. The placement of module components (such as blowers) in the module is primarily a matter of design choice and is not 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.

[0045] The module is configured with LEDs and light pipes to indicate positive culture bottles to the user. Figure 4, a top view of an optional configuration of the module described herein is illustrated. Module 210 has a housing 224, a blower and heater 225 for keeping bottle 230 warm, and a roller 240 with a receptacle for accommodating culture bottles. In the illustrated aspect, positioned inside the roller are bottle presence sensor electronics 250 and culture bottle presence / status indicator electronics 260 (BDSI board includes these electronic components together). A drive motor 270 is provided to rotate the roller 240. In other aspects described herein, the electronics are positioned adjacent to the outside of the roller. The roller 240 housing 224 has six panels 221 that define six roller sectors (222A-222F). As illustrated, approximately one-sixth of the roller contents (assuming the roller is full) are available for pick-up and drop at any given time, because the span of a sector is approximately the same as the span of the opening in the housing, through which bottles are added to or removed from the roller 240. Figure 5A yes Figure 4 240. Culture bottles (not shown) are positioned neck-inwardly in receptacles 220 in drum 240 and are received by brackets configured as light pipes 515. Motor 270 is a direct drive motor that provides high torque, virtually no hysteresis, low noise, reliability, and simplicity.

[0046] In one aspect, the drum 240 is configured such that the motor assembly 270 and the gear box 271 are located within the interior of the drum 240. Figure 5A 2 shows a drum 240 having a receptacle 220 for receiving a culture bottle (the culture bottle is not shown). As described above, the drum 240 is assembled into sections of the receptacle 220 and is Figure 5B 20 is shown in the figure with one of the receptacles 220 removed therefrom. A status indicator panel 273, which is more visible when the panel is removed, is used to illuminate the light pipe 515 to indicate the status of the bottle supported in the light pipe 515. The status indicator panel (BDSI panel) 273 is also removable and removable from the frame 274 of the drum 240. As used herein, "status" is the status of the blood culture bottle determined by the module 210. The status of the blood culture bottle can be positive for microbial growth or negative for microbial growth. In one aspect, the status of the blood culture bottle is communicated by colored illumination of the bottle receptacles in the drum, wherein in one aspect, green light indicates a bottle that is negative for microbial growth and red light indicates a bottle that is positive for microbial growth.

[0047] refer to Figure 5C, provides a top view of the frame 274 from which the status indicator plate segment is removed. Cables 275 provide power to the motor assembly 270. The bottom 276 of the frame 274 is also illustrated. The drive motor assembly 270 drives the drum 240 to rotate axially. The bearings inside the gearbox of the drive motor assembly 270 provide both axial alignment of the drum 240 and the necessary thrust load support required to propel the drum carrying a large number of bottles 230. Reference Fig. 6A , the axis AA of the drive motor assembly 270 is aligned with the axis AA of the drum 240. Therefore, the center of gravity of the drum 240 / drive motor 270 assembly is on the central axis. The drum 240 / drive motor assembly 270 is provided with a lifting mechanism 272 to expose the motor assembly 270 for maintenance by lifting the drum 240. Fig. 6E In one aspect shown, the lifting mechanism is a screw 2720 that advances through a motor assembly support plate 2721 and a guide nut 2722. When advanced upward, the screw 2720 forces a plate 2723 upward. The plate 2723 moves upward along the guide pins 2726. This raises the drum 240 off the drum support 2400 and creates a lifting space 2401 between the drum frame 274 and the rotor 2724 of the motor assembly 270. Figure 6C A locking tool 2402 is provided and can be inserted into the lifting space 2401 to lock the drum in place relative to the motor assembly 270 so that the motor can be serviced without bearing the weight of the drum 240. Fig.6D An example of a suitable locking tool 2402 is illustrated in FIG. As shown, the locking tool 2402 has a handle 2403 secured to a support bracket 2404. The locking tool 2402 is inserted between the rotor 2724 and the drum frame 274 (illustrated in phantom). When the motor assembly 270 is serviced, the weight of the rotor 2724 and the drum frame 274, which is fastened to the rotor via hexagonal bolts 2725, is supported by the maintenance frame 2405. Fig. 6E A detailed view of the lift assembly 272 is provided in . Cable 275 provides power to the motor assembly 270. As previously explained, the screw 2720 advances upward through the plate 2721 and the guide nut 2722 to raise the support bracket 2723 (which travels along the guide pin 2726), thereby lifting the weight of the drum 240 off the motor assembly 270 for servicing.

[0048] As previously mentioned, the device is provided with a status indicator panel 273. As mentioned above with reference to Figure 5A and Figure 5BAs explained, the drum 240 is arranged with multiple columns of receptacles 220, divided into multiple sections with multiple columns (e.g., four columns) in each section. In one aspect, one column in a section is reserved for reference bottles. User access to the various sections in the drum will be through a door that will give access to a single section (one of 222A-222F of the receptacles 220) in the drum 240. Figure 4 A drum divided into a plurality of sections is illustrated in FIG.

[0049] To sense bottle entry and removal and provide feedback to the user during user access to the sections 222A-222F in the drum 240, there are bottle presence sensors 250 (bottle sensors) and culture bottle / status indicator electronics 260 (e.g., lights) on the status indicator plate 273. See Fig. 7A Bottle sensors 250 each sense when a bottle is inserted into or removed from a receptacle 220 in sections 222A-222F of the through-door accessible drum 240. The indicator light illuminates a light pipe 515 in the drum receptacle 220 that transmits light to be visible to a user viewing the receptacle through the open door. This requires that the light pipe 515 of the receptacle 220 be aligned with the culture bottle / status indicator electronics 260 in the status indicator plate 273. When properly aligned, the module 210 can positively 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.

[0050] To access all of the bottles in drum 240, the user must cause module 210 to rotate the drum. As each section of drum 240 rotates into view through the open door, the user can have a way to ensure that the exposed section of drum 240 (one of 222A-222F) is aligned with the bottle presence sensor 250 and status indicator light 260 of status indicator plate 273. Fig. 7A In one aspect, the module 210 may have an alignment mechanism (located on the measurement board 545 or BDSI 273) for aligning the receptacles 220 in the drum 240 with the bottle presence sensor 250 and status indicator light 260 provided on the status indicator plate 273. Those skilled in the art will appreciate that alignment may be achieved in many different ways and that this alignment mechanism is merely one example of a sensor that may be used to align the drum 240 with the module door and thus achieve alignment of the bottle receptacles with the bottle presence sensor 250 and status indicator light 260. Such alignment may be manual (e.g., an operator aligns the drum faceplate with the door opening); semi-automatic (a mechanism that the operator may control to incrementally advance the drum until alignment is achieved) or automatic (a datum (e.g., an alignment mark) that is detected and based on its detected position, the drum is aligned with the datum(s).

[0051] In one aspect, the alignment mechanism further comprises alignment marks and segment identification marks attached to the drum panel that separate the drum segments. The measuring board or BDSI may include an alignment section having an optical sensor that detects the marks on the drum panel as they pass by the optical sensor as the drum rotates, the optical sensor being provided on the measuring board 545. See Figure 5B , the BDSI 273 is located near the interior of the drum so that it can detect the markings on the drum panel 221. The optical sensor communicates with the main controller, which in one aspect of the module described herein informs the user / operator of the drum sections that can be accessed through the open door.

[0052] The status indicator plate 273 is also referred to as a bottle detection and status indicator (BDSI) plate 273. The status indicator plate 273 may be located behind the drum and aligned with the door opening, such as Fig. 7A As described above, the module may also have a measurement board 545. In one aspect, the measurement board 545 is Figure 7B Controller board shown. Reference Fig.13 In one aspect, the measurement plate 545 is fixed near the exterior of the drum 240 .

[0053] In one aspect, each column of status indicator boards 273 can be a single board or multiple interconnected boards. In the illustrated aspect, the four columns of status indicator boards are connected to each other using, for example, a flexible ribbon cable (not shown). The measurement board 545 is connected to the main controller board (not shown) for system communication. Fig. 7A As shown, the status indicator plate 273 is mounted on the inside of the drum frame. In contrast, the measurement plate 545, which may include an alignment section, is located on the outside of the drum so that the marks 2734, 2735 can be detected by the sensor 2739 on the measurement plate 545.

[0054] refer to Figure 7C In one aspect, the optional alignment section 2731 can have a row of alignment sensors 2732 and a row of segment identifier sensors 2733. In one aspect, the alignment sensors and the segment identifier sensors can both be simple optical switches on the measurement board 545. Figure 7C As shown, the top row may include four alignment sensors 2732, and the bottom row may include segment identifier sensors 2733. The alignment sensors 2732 and segment identifier sensors 2733 may each have a recess 2738 in which a sensor 2739 (e.g., an optical switch) is disposed. Adjacent segments of the drum 240 may be separated by vertical panels 221 (also referred to as drum ribs or walls) extending from the outer surface of the drum. These Figure 4 and Figure 6C As shown in the figure. Figure 4As shown, the drum panels or ribs 221 on either side of the segments (222A-222F) are aligned with the fascia 2240 of the housing 224 so that it looks neat when the user opens the door. The drum ribs 221 also extend to the inner surface of the drum, as shown in FIG. Figure 5C shown.

[0055] Each drum rib 221 inside the drum will have multiple marks (2734, 2735), one mark 2734 for drum alignment, and another set of one or more marks 2735 for segment identification below the drum alignment mark 2734. When the marks 2734 and 2735 pass through the notch 2738, the marks 2734 and 2735 are detected in the corresponding alignment sensor 2732 and segment identification sensor 2733.

[0056] As mentioned above, each panel or rib 221 carries two marks, namely the alignment mark and the sector identifier mark. Fig.7D As seen in , the alignment mark can be a continuous mark that spans all four alignment sensors 2732. When the drum is rotated so that all four optical switches in the alignment sensors 2732 register the presence of the mark, this indicates that the drum is in alignment. In one aspect, the sensor has a light beam that is transmitted through a gap in the sensor. When the mark enters the gap, the light beam is interrupted and the interruption is recorded as an indication that the mark is present. Although the mark interrupts the signal, this is referred to as the "on" state of the sensor because, in this state, the sensor detects the presence of the mark. The segment mark 2735 is configured as a unique identifier for a particular segment of the drum. Therefore, the size and number of the segment marks vary for each segment so that each segment produces a signal that is unique to its particular segment. As shown in the figure, the sensor 2739 is positioned in the corresponding notch 2738 through which the alignment mark / segment identifier mark passes. The sensor is configured as a transmitter / receiver pair, and in Figure 7C Only one of the emitter / receiver pairs is illustrated in FIG. 1 . In normal operation, the signal from the emitter to the receiver is uninterrupted. As the marks pass the sensor, they "interrupt" the light beam and this provides an indication that the mark is present in the sensor. For a positive indication of alignment, the alignment mark must interrupt the optical path of all alignment sensors. The number of "broken" signals to the segment sensors at that precise point will indicate which segment is about to be rotated into position. Reference Figure 8, the number of sensors "activated" by the segment flag passing through the identifier sensor can inform the control software which segment is present at the sensor location. At the point when the alignment flag 2734 fully activates all alignment sensors 2732, the segment identifier flag 2735 has activated the segment identifier flag sensor 2733 with a wider margin. This will ensure that the correct segment of the drum 240 is identified when the alignment is correct. As previously described, the alignment flag has the same size and configuration for each segment, while the segment flags each have a unique configuration so that the signal generated by the segment flag indicates a specific segment of the drum. As described above, the above-mentioned alignment mechanism is an example of a mechanism that can be used to align the drum. Those skilled in the art are aware of other suitable mechanisms for achieving alignment of the drum with the door and other module electronic devices (e.g., the status indicator plate 273).

[0057] In another aspect, the drum can have a drum motor encoder 2742 that communicates with the measurement board 545. In this aspect, the alignment section 2731 includes a Hall effect sensor 2740. In one aspect, the Hall effect sensor is placed approximately in the center of the measurement board 545, such as Figure 7B As shown. The Hall Effect sensor detects a sign which is a magnet 2741 in one aspect. Reference Fig. 7E , magnet 2741 is positioned on drum rib 221. This position is by way of example, but placing the magnet on the rib rather than on some other drum surface brings the magnet closer to the Hall effect sensor and thereby provides a greater likelihood that the magnet will trigger the Hall effect sensor when it passes over the Hall effect sensor. Magnet 2741 is detected by the Hall effect sensor in a fly-by manner. When magnet 2741 is detected, a signal is communicated to the master controller. Because the master controller now has a starting position, encoder 2742 can then be used to correlate drum rotation with a target position of the drum in the cabinet. There are two goals for alignment. The first goal is that the status indicator 260 in BDSI 273 is aligned with the light pipe 515 in the receptacle 220. The second goal is that the drum rib 221 is aligned with the trim 2240 of the housing 224 so that when the door 207 is open, only the portion of the drum between the drum trim is visible. Typically, if one goal is met, the other goal is also met, and the drum is aligned.

[0058] Roller encoder 2742( Fig. 6E) relates shaft rotation to degrees of drum rotation. Since the signal generated when the magnet mark flies past the Hall effect sensor 2740 indicates the origin, the drum encoder can provide information to the main controller to determine the position of the drum and the amount of shaft rotation required to move the drum from a first position to a second position. Although the location of the magnet on the drum periphery is largely a matter of design choice (as long as the magnet will be detected by the Hall effect sensor when it passes by the Hall effect sensor), it is advantageous if the magnet is positioned at or near the column of drum brackets reserved for calibration bottles. Reference Fig.13 , there is a top view of a drum 240 having twenty-four (24) columns. There are four columns of bottle stations in each of the six sections 222A-F. In one aspect, the drum is modified to include a seventh section containing a single column. The seventh section can contain calibration bottles with fixed fluorescence in one aspect. Figure 8 5451. The number of columns in each section and the total number of columns are indicated in . When the calibration bottle is placed adjacent to the measurement plate sensor 5451, the fluorescence induced by the light source 5451 is detected by measurement and compared with the known fluorescence associated with the calibration bottle. If the measured fluorescence is within the acceptable tolerance of the known fluorescence, it is determined that the measurement plate detector is operating correctly. In one aspect described herein, the magnet mark is located near the seventh section. Those skilled in the art will understand that the number of columns, the number of rollers, the roller capacity and other such aspects are a matter of design choice and are described herein for illustrative purposes.

[0059] 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 gear box 271 which is coupled to the bottle drum 240.

[0060] In one aspect, the main controller has a lookup table of roller conditions that may cause roller misalignment. The lookup table provides roller conditions that cause roller misalignment. For example, the alignment tolerance of the roller 240 can be determined by filling the roller 240 and recording the loading arrangement that causes the roller 240 to change from an aligned state to a misaligned state. As used herein, the aligned state is when the bottle presence sensor 250 in the BDSI 273 is aligned with the bottle 230 so that each bottle presence sensor 250 detects the bottle 230 when the alignment sensor 2732 indicates that the roller is aligned. The misaligned state 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 sensor 2732 indicates that the roller 240 is aligned. The boundary conditions are the conditions that change the roller from an aligned state to a misaligned state. These boundary conditions are recorded and used to define the alignment tolerance. When the alignment sensor indicates that the roller is aligned, when the bottle presence sensor 250 for the bottle receptacle 220 with the bottle 230 therein is not illuminated, it is determined that the roller is misaligned. When this occurs, the operator knows that the roller 240 is misaligned.

[0061] In another aspect, the drum motor encoder provides feedback to the operator while the operator is manually moving the drum. This is accomplished by incrementally controlling the movement of the drum 240 so that the operator can determine when the bottle presence sensor indicates the presence of a bottle in the receptacle 220. As described above, the drum encoder increments the drum movement based on shaft rotation. In one aspect, the incremental drum rotation is selected to control how much the drum will rotate in response. Reference Fig.16 , illustrates an example of a range of degrees of incremental movement of the drum 240. In one example, Fig.16 The degrees of rotation between the columns of brackets are illustrated. The degree of bracket rotation from one column in one section to the next is 13.9 degrees. The degree of bracket rotation from a column in one section to a column in the second section is 15.7 degrees. The motor encoder measures the shaft rotation by increments, and based on the increments, the controller can determine the degree of drum rotation. When the drum is rotated manually, the encoder can still increment based on the shaft rotation, and the drum position / alignment can still be determined by the main controller based on the shaft increments communicated from the encoder to the main controller.

[0062] The above arrangement allows the module controller (e.g., measurement board 545 or BDSI 273) to manage roller alignment without the need to communicate with the main controller. Once the module door is open, the measurement board 545 can handle the process of helping the user align the rollers with the bottle detection and status indicator board (BDSI). As long as the correct alignment is determined / indicated as described above, the module will display the status of the station.

[0063] The master controller can also handle the alignment of the drum before the door is opened, so the bottle status of the drum section visible when the user opens the door has been lit when the user opens the door. In one aspect, the master controller determines when the local controller (i.e., the controller in the module instead of the master controller) will activate the status light on the status indicator board 273. In order to start the manual workflow, for example, the master controller can send a command to the module controller to start alignment. From there, the master controller or the module controller can manage the drum movement and status display. The local controller can be located anywhere in the module. In one aspect, the local controller is located on the measurement board 545. In another aspect, the local controller can be located on the status indicator board 273. The door of the module can be opened for various reasons described herein. When the module door is closed, the status indicator light is turned off. A command from the master controller can start alignment. When the door is to be opened, the alignment process begins, and the drum advances until the alignment mark activates all alignment sensors installed on the measurement board 545. When alignment is achieved, the local controller can also send to the master controller a specific drum section aligned with the door determined by the segment sensor and a segment mark detected when the alignment mark has activated the alignment sensor.

[0064] In one aspect, the master controller cooperates with and provides a status map for the module 210 based on the information from the status indicator board 273. The status map is updated when a user manually enters and removes bottles from the drum, or when bottles are added or removed by an automated device that communicates with the module 210. When the door of the module is to be opened, the master controller shares the status map with the status indicator board 273. When bottles are added to or removed from the module 210, the map is updated and shared with the master controller. If the module is not operating in isolation mode, the master controller can share information with the command center.

[0065] In one aspect, the local controller will enter an error state and indicate to the user that the module door must be closed. The conditions that may cause the error state are primarily a matter of design choice, but may be things like module temperature drop, misalignment, and the like.

[0066] like Fig. 7A As shown, the status indicator board is equipped with a plurality of lights that can convey information to the user. Although located behind the drum 240 and the bottle receptacle 220, the lights convey information to the user through the light pipe 515 in the receptacle 220. In one aspect, the status indicator board 273 can convey information as a pattern of light / light of different colors. The light pattern / color / meaning is a matter of design choice. Examples of the information conveyed include station / receptacle status (blocked, available, etc.) and bottle status (positive, negative, etc.). The displayed status is communicated from the main controller to the local controller.

[0067] The measurement board 545 may be in communication with a panel that communicates the alignment status to a user. Fig. 9 is an example of a progression of alignment states displayed, where multiple lights are used to communicate information about the alignment state of the instrument. For example, when the alignment mark 221 is not aligned with the alignment sensor 2731, the lights are all dark 545_1. As the drum section moves into alignment, the columns illuminate as the mark begins to activate the alignment sensors moving from left to right (first illuminating the left column 545_2) or from right to left (first illuminating the rightmost column 545_3). This progression of the alignment mark through the alignment sensors (from left to right or from right to left) is illustrated for detection of the alignment mark 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 mark, all alignment sensor indicator lights are illuminated (545_8). In another aspect, the panel will simply communicate no alignment (all lights off) or full alignment (e.g., all lights on).

[0068] Once all alignment sensors are illuminated, the status indicator changes to station state 273_9, and the user can begin manual operations, such as placing a bottle into or removing a bottle from module 210. The panel will still provide an indication of alignment, but will have a certain tolerance built in, as the rollers may move slightly during manual operations. This will avoid triggering misaligned readings that may require a module reset. In one example, once full alignment is achieved, alignment continues to be indicated as long as the leftmost or rightmost alignment sensor continues to detect the presence of the mark. If no alignment sensor detects the mark, the local controller turns off all indicator lights, and a new alignment protocol can be started.

[0069] Once alignment is confirmed, the panel 273-9 communicated with the status indicator plate 273 will indicate the status of each bottle in the receptacle. For example, a two-way cross-hatched light indicates a sample that is negative for microbial growth (row 1, column 1, row 3, and row 8, and row 5, column 4), and a one-way cross-hatched light can indicate a bottle that is positive for microbial growth (rows 2, 4, 6, 8, and 9, column 1; row 1 and row 5, column 2; rows 2, 3, 5, 6, and 8, column 3; and rows 2, 7, and 9, column 4). The unlit light indicates that there is no bottle at those positions. An advantage of this design is that the user can manually advance the drum when the door is open. In order to automatically advance the drum, it is advantageous to close the door so that nothing is captured in the advancing drum. In one aspect, the drum may need to be powered off when the door is open. In this operating mode, the drum may not be able to be advanced when the door is open.

[0070] On the other hand, instead of Fig. 9Instead of using light pipes to transmit bottle status as described in the context of , a BDSI panel can be provided on the outside of the drum to transmit alignment information. The BDSI controller will be connected to the BDSI panel to illuminate the indicator, which can be a light pipe, lens, etc.

[0071] As described above, the rotating drum rotates past the measurement plate 545. (The alignment performed by the measurement plate is a shark fin alignment, not a BDSI alignment) Since the drum 240 rotates past these various detection devices on the measurement plate, the measurement occurs in what is described as a "fly-by" manner, where the rotating drum moves the bottle past the measurement electronics when the measurement is performed. The measurement is performed to determine whether the blood culture bottle is positive or negative for microbial growth. Therefore, a measurement sensor on the measurement plate 545 is provided to interrogate the bottle to determine whether its internal gas composition or pH is dynamic (i.e., changing) in a manner that indicates metabolic activity inside the bottle due to microbial growth. For example, it can be determined that a bottle with a measured increase in carbon dioxide or a measured decrease in oxygen concentration over time is positive for microbial growth. In order to make this determination, the optical sensor is aligned with 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 in the bottle will depend on what the sensor is measuring. The headspace in the bottle is the portion of the bottle interior where the gas is separated from the liquid and solid (i.e., sample, nutrients, etc.) in the blood culture.

[0072] Since the culture bottle can be interrogated multiple times before being determined to be positive or negative for microbial growth, the measurement conditions must be sufficiently consistent between measurements, or the measurement may need to be adjusted if the distance changes. This means that the light from the interrogation sensor 2501 and the distance from the bottle sensor to the photodiode detector 2602 should remain relatively constant between measurements.

[0073] As described above, as the drum 240 with the rows of bottle receptacles 222 rotates past the measurement plate 545, the bottles are interrogated on a column-by-column basis. Figures 10A-10I , the sensor (e.g., light source 5451) and detector 5452 are provided in a housing 5450, which is fastened to and extends from the measurement board 545. The light source 5451 is positioned around a single light detector (photodiode 5452). The housing has a fastening mechanism (flange 5453) for fastening the housing 5450 to the measurement board 273. Fig. 10BAs shown, the housing 5450 has ports 5454, 5455 for receiving a light source 5451 and for receiving a photodiode detector 5452. The ports 5454, 5455 are configured so that the light source 5451 surrounds and is angled toward the photodiode detector 5452 so that light emitted by the light source 5451 intersects above the photodiode detector 5452 on a bottle sensor (not shown) directly opposite the photodiode detector 5452.

[0074] As the distance between the bottle and the measurement plate 545 increases, the combination of the diffused excitation light from the light source 5451 and the fluorescence it induces in the bottle sensor further away from the photodiode detector 5452 causes the signal produced by the photodiode detector 5452 to decrease. The light source 5451 can be positioned radially farther from the photodiode 5452 because the intersection point of the light from the light source 5451 with respect to the bottle sensor is the point that provides inter-measurement consistency. It is advantageous if the light emitted by the light source 5451 intersects the bottle behind the bottle sensor directly opposite the photodiode. The intersection point is far enough behind the bottle sensor to cause the illumination of the sensor to be off-center, so that the fluorescence induced by the light source 5451 is partially outside the field of view of the photodiode 5452.

[0075] As the bottle moves away from the measurement plate 545, light from the light source 5451 converges to the center of the bottle sensor disposed in the blood culture bottle and thus moves into the field of view of the detector 5452. This additional fluorescence of the sensor caused by the additional light from the light source impinging on the bottle sensor offsets the reduction in fluorescence detected by the detector 5452 due to the fact that the bottle and the sensor in the bottle are slightly further away from the detector 5452.

[0076] refer to Fig. 10C , housing 5450 has eight light sources 2501 therein. Four of the light sources are of a first color and are labeled 2501_1. The light sources are light emitting diodes (LEDs). In one aspect, four of the light sources are of a second color and are labeled 2501_2. In one aspect, the first color is green and the second color is cyan. As shown, the colors of the light sources alternate around the photodetector 2601. Housing 5450 having a port 5454 for receiving the light source 2501 and a port 5455 for receiving the photodiode detector 2601 is illustrated in the upper right portion. Figures 10D-10I The transition of light shining on the bottle sensor (from closer to farther away) is illustrated. Figures 10D-10F This transition is illustrated for the cyan LED, and Figure 10G-10IThe transition of the green LED is illustrated (again, from closer to farther away). The above design mitigates measurement-to-measurement variations due to measurement-to-measurement differences in the distance between the light source / photodetector and the bottle sensor. The intensity of a diffuse light source decreases in proportion to the square of the distance from the light source. This is why the photodiode signal generated by the fluorescence produced by the light from the light source decreases as the distance between the measurement board 545 and the bottle increases. Not only does the intensity of the fluorescence received by the photodiode decrease, but the intensity of the source light shining on the sensor also decreases.

[0077] refer to Fig.11 , the bottle drum 240 has a receptacle 220 for receiving a culture bottle disposed therein with the neck facing inward as described above. The receptacle 220 has a light pipe 515 formed in a bottom portion of the receptacle, which also defines the bottom edge of the receptacle 220. The light pipe is formed of a material that transmits light through the light pipe structure but prevents light from emitting from the light pipe to prevent significant crosstalk from an illuminated light pipe to an unilluminated light pipe. Examples of suitable materials include polycarbonate (e.g., Makrolon 2258) and acrylic (e.g., polymethyl methacrylate). (before ) is a trade name of Covestro (formerly Bayer MaterialSciences). These materials are all polycarbonate, which is a very tough, high-impact plastic material. Translucent materials can be considered, but partially transparent light pipe materials may make perceiving the color of the light pipe more challenging.

[0078] Referring again to the status indicator plate 273, the LED that illuminates the light pipe 515 can be a plurality of LEDs that can illuminate the light pipe in a plurality of different colors, each LED indicating a different state of a blood culture bottle held in a receptacle 220 having the light pipe. In one aspect, the LED that illuminates the light pipe is on the status indicator plate and is about 5 mm from the light pipe. As described herein, once the bottle status is determined, the BDSI determines the color (e.g., red for positive, green for negative, etc.) that illuminates the light pipe 515 in conjunction with a local controller or a master controller. 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 bottle bottom 416 is secured in the receptacle by tabs 417.

[0079] Fig. 12A4 is a perspective view of a light pipe receptacle 515 having a light incident end 419 and a tab 417. The light pipe 515 is configured as a waveguide for an LED at the light incident end. Thus, the light pipe is configured to have total internal reflection to make it suitable as a waveguide. In one aspect, the light pipe 515 has a refractive index of about 1.52, which is higher than the refractive index of surrounding air. In one aspect, the light pipe is clad, and the refractive index of the waveguide portion of the light pipe 515 is higher than the refractive index of the cladding on the light pipe 515. Fig. 12B is the light incident end 419, and Fig. 12C It is tab 417 .

[0080] In order for the light pipe to have the necessary total internal reflection, any curves must be gentle, with no sharp curves or dead ends. Gentle curvature is Fig. 12A 421 is illustrated by way of example in the illustration. In one embodiment, the light pipe has a main body length of about 110 mm from the light inlet end 419 to the tab 417. For purity of transmission, it is advantageous if the presence of foreign particles and bubbles is minimized. In one aspect, the light pipe is a molded polyacrylate. Although 3D printing is contemplated to form the light pipe, it is easier to control the quality of a light pipe formed by molding. In one aspect, the light pipe has very low, little or near zero internal absorption and is free of foreign particles and bubbles. For example, but not limited to, the low or little internal absorption is less than about 0.2 dB cm -1 .

[0081] refer to Fig.13 , the bottles 230 (facing inward) in the drum 240 are placed into one of the six sectors (222A-222F) in the module 210. The sectors are defined by vertical panels extending outward from the drum 240. The span between adjacent panels is approximately equal to the span of the door into the housing 224 to completely shield the user from the interior of the module when the user is picking up and placing sections of culture bottles. The module 210 also includes a blower and heater 225 for keeping the bottles 230 warm. Positioned in the interior of the drum is a status indicator board 273. A drive motor assembly 270 is provided to rotate the drum 240. The measurement board 545 is positioned on the outside of the drum and acquires the flight distance by measuring the bottle and drum marks to determine the bottle status and drum alignment, respectively.

[0082] refer to Fig.14, the receptacle is shown as having a light pipe 515 to divert light from the indicator LED 260 from the distal end 525 of the receptacle (i.e., the inside of the drum 240 in which the receptacle is disposed). The light pipe 515 cradles the bottle 230, if present, and extends past the proximal end 420 of the receptacle (i.e., the outer surface of the drum 240). The flat spring 510 presses against the upper shoulder 535 of the culture bottle 230 to hold the culture bottle 230 against the lug 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 carried by the status indicator plate 273. As shown in FIG. Figures 15A-15E As shown in FIG. 2 , the spring is enmolded into the bottle holder 220 .

[0083] The light pipe 515 is aligned with the indicator LED 260 on the status indicator plate 273. The surface of the end of the light pipe 515 outside the bottle drum 240 is textured to disperse the light from the indicator LED 260. When the bottle crimp cap 410 is placed in the container 220, it interrupts the bottle presence detector 250 (e.g., an optical switch or proximity sensor). The indicator LED 260 and the bottle presence detector 536 are located on the status indicator plate 273, which is located on the interior of the drum 240 and is arranged to correspond to each bottle 230 that can be accessed by the user in the drum 240. The bottle presence detector 250 is monitored when the door of the module is opened to detect in real time when a bottle 230 is placed in a receptacle or when it is removed from a receptacle.

[0084] Fig.15A A portion of a drum 240 is shown having multiple vertical rows of receptacles 220. The drum is shown in cross-section to show the culture bottles 230 supported in the receptacles 220. The top receptacles 220 are empty. Fig.15A In the embodiment illustrated in FIG. 5 , a pivot arm 551 is provided in place of the leaf spring 550 described previously to secure the culture bottle 230 in the receptacle 220. When the bottle 230 is pushed into the receptacle 230, the pivot arm 551 rotates clockwise to secure the culture bottle 230 in the receptacle. The resistance to the pivot arm 551 is applied by a coil spring 552 secured in the receptacle by a pin 556.

[0085] exist FIG. 15B to FIG. 15E The picture shows Fig.15A An alternative to the receptacle shown in . Fig. 15B , Fig.15AThe pivot arm 551 shown in the figure is replaced by a deformable material 553. In one example, the deformable material 553 is a peristaltic tube, but other conventional deformable materials are contemplated. The key aspect of the deformable material is its elasticity in recovering its undeformed shape after each instance of deformation due to the insertion of a culture bottle in the receptacle. The bottom portion of the receptacle 220 is a light pipe 515.

[0086] The deformable material 553 is placed in the tapered portion 554 of the receptacle 220. Fig. 15C , an end view of the receptacle 220 illustrates the deformable material 553 at the top portion of the receptacle (along the tapered portion 554 of the receptacle). In addition to the elastomeric peristaltic tubing described above, suitable deformable materials include elastomeric materials and foam materials.

[0087] Fig.15D 4 is a perspective view of a receptacle 220 with a portion of a second receptacle formed above the receptacle 220. The culture bottle is held in the receptacle as described above. The lugs 417 hold the culture bottle 230 in the receptacle 220. Other materials are contemplated for the deformable material, such as a material having sufficient frictional properties when used in contact with the bottle 230. This friction prevents rotation of the bottle 230, thereby allowing the measurement system to obtain a high quality signal with less noise caused by bottle vibration due to the movement of the holder. Fig.15E is a top view of a culture bottle held in receptacle 220 with light pipe 515 .

[0088] In one aspect, the modular cabinet in which the roller bracket is placed can have a heat distribution system made of lightweight moldable expandable polypropylene (EPP) foam. This is referred to as a molded foam heat distribution assembly in this article. Although EPP foam is described herein, other moldable synthetic materials such as expandable polystyrene (EPS) can be considered. EPP foam is more resilient and less brittle than EPS, making it more suitable for applications where the foam may be subjected to operating stresses. Those skilled in the art can select suitable moldable foams for the molded foam heat distribution assembly described herein.

[0089] The molded foam heat distribution assembly is customizable, which is an advantage when it is desired to provide a relatively uniform ambient heated air environment (i.e., relatively free of temperature gradients). The customized heated environment can be customized to ensure that the bottles in the rack do not have different temperatures, and that the ambient temperature and the actual temperature of each bottle in the rack are substantially uniform (with an acceptable tolerance of ± about 5%). That is, the ambient temperature in the cabinet should not vary by more than ± about 5% at any location in the cabinet, and the temperature of each bottle in the rack (when in equilibrium in the heated cabinet) should not vary by more than about ± about 5%. For example, if the target ambient temperature of the incubator is 36.5°C, the ambient temperature can vary by ± 1°C, which is a tolerance of ± 2.7% when incubating one or more roller racks that are fully filled (e.g., 240 bottles). The ambient temperature and the bottle temperature will have a wider degree of variation from each other because it takes time for the ambient heat to raise the bottle temperature to the ambient heat temperature.

[0090] In another aspect, 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 and directs it onto a rotating drum stand (which has culture bottles therein). The hot air is directed onto different rows of rotating drum stands by a plurality of ducts formed in the molded EPP foam insert. The heater / blower units are assembled in a dual cabinet system such that one unit is below the rotating drum stand in the bottom cabinet and the other unit is placed above the rotating drum stand in the top cabinet. Fig.18 This arrangement is illustrated in FIG, which is described in detail below. In one aspect, the heater / blower units are mounted on tracks to make them easy to service. The units are held in place by leaf springs to hold them in place. In one aspect, as shown below Figure 18-20 As shown, there are five (5) ducts 1221 molded into the side insert 1220A. The ducts 1221 provide a more targeted airflow so that all bottles in the rack are generally evenly exposed to the heated blowing air. Blowing the hot air through the air distribution system provides a relatively uniform temperature distribution throughout the cabinet in which the rotating drum rack is placed. Specifically, the ducts provide a more uniform air distribution, and the blower provides circulating air that also distributes the warmed air throughout the cabinet, ensuring more uniform heating of the bottles carried in the rotating drum rack.

[0091] In an optional aspect, the molded foam insert heat distribution assembly can have additional conduits, such as conduits in the rear portion of the molded foam insert heat distribution assembly. Fig.24 The rear pipe 1223 is shown in the figure, Fig.24 is a top view of the molded foam insert heat distribution system above the top component 1220C.

[0092] In one aspect, the motor for the heater / blower unit is a DC input centrifugal blower. Such a blower has a suitably compact design and a sufficiently small exhaust that cooperates with the molded foam insert heat distribution assembly to provide suitable airflow into the assembly. In one aspect, the blower itself is placed in the molded foam insert heat distribution assembly. The heater and RTD may also be received in the molded insert heat distribution assembly in a compartment having an outlet opening that is in fluid communication with the air duct inlet of the molded insert heat distribution assembly. To mitigate heat and air losses, the molded foam insert heat distribution assembly is secured together in a conventional manner. In one aspect, the molded foam panels that form the assembly are secured to each other and to the module frame using snap fits and sheet metal clamshells. The clamshells are secured together using, for example, screws. In addition to providing thermal insulation to the interior of the module, the molded foam insert heat distribution assembly mitigates sound emanating from the module and dampens vibrations from the interior and exterior of the module.

[0093] With regard to adding a molded foam insert heat distribution assembly to provide a duct for circulating hot air through the drum, the assembly is formed at the rear of the frame that receives the drum support. Fig.17 A module 1210 is illustrated according to one aspect of an apparatus for incubating, storing, and monitoring blood culture bottles as described herein. The module 1210 has two cabinets 1211 each for receiving a roller rack 1240 as described elsewhere herein. Fig.17 12, cabinet 1211A does not have a roller rack placed therein (but can receive one), while cabinet 1211B does have a roller rack 1240 therein. When the modules 1210 are in operation, the roller rack 1240 is in each cabinet. Module 1210 is illustrated next to a different 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 transported into module 1210. Module 1212 is described in U.S. Provisional Application 63 / 390,535, which was filed on July 19, 2022, and is incorporated herein by reference.

[0094] Compartment 1211A has therein a foam insert heat distribution assembly 1220. Foam insert heat distribution assembly 1220 is formed by molded side duct portions 1220A and a recessed middle section 1220B. The recessed middle section 1220B is formed to accommodate the curvature of the drum support 1240 and allow the air duct 1221 to be as close to the drum support 1240 as possible without interfering with the drum rotation.

[0095] Fig.18is a view of the molded foam insert heat distribution assembly in communication with the heater / blower assembly 1245A / 1245B for module 1210 without other module components. For the dual 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 the heater / blower assembly 1245A and 1245B, respectively. The dual cabinet structure has the heater / blower 1245A and molded foam insert heat distribution assembly 1220A as the top cabinet and the heater / blower 1245B and molded foam insert heat distribution assembly 1220B as the lower cabinet. The orientation is different, with the heater / blower assembly 1245B being in an inverted orientation when compared to the orientation of the heater / blower assembly 1245A. Reference Fig. 20 , it is observed that molded foam insert heat distribution assembly 1220B is a mirror image of molded foam insert heat distribution system 1220A. Although received into the module in a different orientation, the parts are interchangeable. Since the parts are uniform, this provides ease and efficiency of manufacturing.

[0096] refer to Fig.25 , the frame 1250 of the module 1210 is shown without the rotating drum support positioned therein. The molded foam insert heat distribution assemblies 1220A and 1220B are positioned at the rear of the compartments 1211A and 1211B. Fig.25 and Fig. 22 Also shown is a housing 1260 in which the heater / blower assembly 1245A is received (in Fig. 22 and Fig.25 Only the top heater / blower assembly is visible. Fig.21 and Fig.23 The bottom heater / blower assembly 1245B is illustrated in FIG. To allow access to the heater / blower assembly 1245, a long handle 1270 extending to the front of the frame 1250 is provided. Tracks 1280 are provided so that the heater / blower assembly 1245A / 1245B can be easily slid out of the housing 1260 using the handle 1270 for servicing. Fig. 22 , the housing 1260 is shown in phantom so that the heater / blower assembly 1245A is visible therethrough. The heater / blower assembly 1245A is held in the housing 1260 by spring clips 1290. When the handle 1270 is moved forward, the heater / blower assembly 1245A is pushed out of the housing 1260 for servicing. The handle 1270 is secured to the frame by screws 1275. Fig.23Shown are a heater / blower assembly 1245B and a handle 1270 for pulling the heater / blower assembly 1245B out of its housing.

[0097] The molded foam insert heat distribution assemblies 1220A and 1220B provide several advantages. Specifically, they can be assembled and placed in a module using minimal additional components (such as metal plates and fasteners) used in more conventional heat distribution systems. In one aspect, the molded foam insert heat distribution system is an assembly of five molded foam components. Those are Fig.19 The three components 1220A, 1220B and 1220A shown, together with the top component 1220C ( Fig.24 ) and bottom member 1220D ( Fig.21 ) together to form an integrated air duct. Fig.19 As shown, component 1220A has a tab 1225 that is received by a recess 1230 in component 1220B. This allows component 1220A to be assembled to component 1220B by inserting tab 1225 into recess 1230. The air distribution system formed from molded foam provides airflow with less turbulence. Because the molded foam inserts fit together, putting the components together is easier and assembly errors are less likely to occur. In another aspect, duct 1221 is tapered to improve airflow. In Fig.19 and Fig. 20 12. In addition to the tapered ducts 1221, the molded foam heat distribution assembly has smaller ducts / vents to provide more heated airflow paths that can be directed toward more bottles carried by the rack 1240.

[0098] In one aspect, module 1210 has a molded foam insert thermal distribution assembly that can be simply assembled by joining the components together. In one aspect, the individual molded components can have a tongue-in-groove feature to facilitate assembly. In one aspect, five components are assembled to form a molded foam insert thermal distribution assembly. Extruded ribs (allowing larger objects to be received into smaller openings) and Christmas tree fasteners can be used to further enhance the ease of installation. Those skilled in the art are familiar with suitable fasteners that can be used to assemble the molded foam insert thermal distribution assembly together, and such fasteners are not described in detail herein. The molded foam insert thermal distribution assembly is fluidly coupled to a heater / blower unit 1245A / 1245B as described herein.

[0099] In one aspect, the heater / blower unit 1245A / 1245B has a lightweight design. Features such as handles, side rails, and leaf springs allow the heater / blower unit to be easily inserted into the module, securely held by the module, and easily removed from the module. The leaf springs also secure the heater / blower unit 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 anchor / secure the cable 1295 to the heater / blower 1245.

[0100] The molded foam insert heat distribution assembly described above allows for targeted airflow distribution.

[0101] As explained herein, the module rotates the drum to position the bottles for both user access and automated access. The module also rotates the culture bottles to agitate them.

[0102] The apparatus described herein provides the following advantages: 1) a reduction in noise (i.e., the ratio of the growth signal to the reference signal should be unaffected by vial position, temperature, and sensor variability); 2) detection of growth in vials that are subject to delays in logging into the system (i.e., the dual measurements described above provide a reference so that the contents of the vial do not need to be sampled continuously during growth to confirm positivity by detecting growth acceleration); and 3) an indicator of signal quality (i.e., the reference signal is an independent indicator of the health of the station hardware).

[0103] An apparatus for storing and monitoring blood culture bottles is described herein. The apparatus has a frame that defines at least one cabinet. The cabinet can receive therein a drum-shaped support having an outer periphery and an inner periphery. The outer periphery has a diameter that exceeds the diameter of the inner periphery. The drum has a plurality of receptacles having a proximal end at the outer periphery and a distal end at the inner periphery. Each receptacle can receive a blood culture bottle having a bottom section and a neck section. The bottle can be received by the receptacle so that the bottom section is received at the distal end of the receptacle, or the neck section is received at the distal end of the receptacle. In one aspect, the drum periphery is arranged around the rotation axis of the drum.

[0104] The plurality of receptacles may be arranged in the drum in an array of receptacles, the array having receptacles arranged vertically and horizontally. The vertically aligned receptacles may form columns. The horizontally aligned receptacles may form rows.

[0105] Each cabinet can have a molded foam insert heat distribution assembly. In one aspect, the molded foam insert assembly can be molded foam inserts that are assembled together. Each molded foam insert heat distribution assembly can be in fluid communication with a heater / blower assembly. In one aspect, the frame is disposed in a housing.

[0106] In one aspect, a cabinet in an installation has two molded foam side inserts assembled to a molded foam center insert. In another aspect, the molded foam side inserts can define a plurality of ducts when assembled to the molded foam center insert.

[0107] In another aspect, the heater / blower assembly is in fluid communication with the duct. In another aspect, the duct outlet is directed toward a receptacle in the drum-shaped bracket. In another aspect, the heater / blower assembly is supported by a frame above a cabinet in which the molded foam insert heat distribution assembly is placed or below a cabinet in which the molded foam insert heat distribution assembly is placed. In another aspect, the heater / blower assembly is placed in a housing.

[0108] In another aspect, the frame has handles and tracks to advance the heater / blower assembly into and remove it from the housing.

[0109] In another aspect, a device for storing and monitoring blood culture bottles is described herein. The device may have a drum-shaped support having an outer periphery and an inner periphery therein. The outer periphery may have a diameter that exceeds the diameter of the inner periphery. The drum may have a plurality of receptacles having a proximal end at the outer periphery and a distal end at the inner periphery. Each receptacle may be configured to receive a blood culture bottle. In one aspect, the blood culture bottle has a bottom section and a neck section. The bottle can be received by the receptacle so that the bottom section is received at the distal end of the receptacle, or the neck section is received at the distal end of the receptacle. In another aspect, the drum periphery is arranged around the rotation axis of the drum, and a drive motor may be placed within the inner periphery of the drum aligned with the rotation axis. In another aspect, the device may have a drum motor encoder rigidly coupled to the shaft of the motor shaft of the drive motor.

[0110] The apparatus may have an alignment sensor adapted to detect when the axis of rotation of the drum is not a vertical axis. In another aspect, the apparatus may have a bottle presence sensor adapted to detect the presence of a bottle in a receptacle. The bottle presence sensor may be adapted to detect an alignment state of the drum and a misalignment state of the drum. The misalignment state may be detected when the bottle presence sensor fails to detect a bottle known to be present in a receptacle opposite to the undetected sensor. In another aspect, the drum motor encoder may provide feedback to the operator when the drum support is manually moved by the operator. The drum motor encoder may increment the manual movement of the drum support so that the drum support advances a predetermined number of rotations when manually rotated.

[0111] I describe an apparatus for storing and monitoring blood culture bottles, the apparatus having a frame defining at least one cabinet adapted to receive therein a drum-shaped rack having an outer perimeter and an inner perimeter, the outer perimeter having a diameter exceeding a diameter of the inner perimeter, the drum having a plurality of receptacles having a proximal end at the outer perimeter and a distal end at the inner perimeter, each receptacle configured to receive a blood culture bottle, the blood culture bottle comprising a bottom section and a neck section, wherein the bottle is receivable by the receptacle such that the bottom section is received at the distal end of the receptacle or the neck section is received at the distal end of the receptacle. The drum perimeter is arranged about a rotational axis of the drum. The plurality of receptacles are arranged in the drum in an array of receptacles, the array having receptacles arranged vertically and horizontally, vertically aligned receptacles forming columns, and horizontally aligned receptacles forming rows. The apparatus also has a molded foam insert heat distribution assembly in each cabinet, the molded foam insert assembly comprising molded foam inserts assembled together. Each molded foam insert heat distribution assembly is in fluid communication with a heater / blower assembly.The frame is disposed in the housing.

[0112] Apparatus in which two molded foam side inserts are assembled to a molded foam center insert. In one aspect, the molded foam side inserts define a plurality of ducts when assembled to the molded foam center insert. In other aspects, the heater / blower assembly is in fluid communication with the ducts. In one aspect, the duct outlets are directed toward receptacles in the drum-shaped support. In other aspects, the heater / blower assembly is supported by a frame above a cabinet in which the molded foam insert heat distribution assembly is placed or below a cabinet in which the molded foam insert heat distribution assembly is placed. In other aspects, the heater / blower assembly is placed in a housing. In other aspects, the frame includes handles and tracks to advance the heater / blower assembly into and remove it from the housing.

[0113] An apparatus for storing and monitoring blood culture bottles is described herein, the apparatus having a drum-shaped support having an outer periphery and an inner periphery therein, the outer periphery having a diameter exceeding the diameter of the inner periphery, the drum having a 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 section and a neck section, wherein the bottle is receivable by the receptacle such that the bottom section is received at the distal end of the receptacle, or the neck section is received at the distal end of the receptacle. In the above apparatus, the drum periphery is arranged around an axis of rotation of the drum. In other aspects, a drive motor is placed within the inner periphery of the drum aligned with the axis of rotation. The apparatus also has a drum motor encoder rigidly coupled to a shaft of a motor shaft of the drive motor.

[0114] In the above apparatus, in one aspect, the apparatus further comprises an alignment sensor adapted to detect when the axis of rotation of the drum is not a vertical axis. The apparatus further comprises a bottle presence sensor, the bottle presence sensor detecting the presence of a bottle in a receptacle. The bottle presence sensor is adapted to detect an aligned state of the drum and a misaligned state of the drum. In one aspect, a misaligned state is detected when the bottle presence sensor fails to detect a bottle known to be present in a receptacle opposite to the undetected sensor. In the above apparatus, the drum motor encoder provides feedback to the operator when the operator manually moves the drum support. In other aspects, the drum motor encoder increments the manual movement of the drum support so that the drum support advances a predetermined degree of rotation when manually rotated. In one aspect, the above drum-shaped support is capable of vertical movement relative to the drive motor. The drum-shaped support comprises a lifter for raising the drum relative to the motor. The drum-shaped support described herein may have a locking tool for supporting the drum-shaped support on a frame in which the drum-shaped support is arranged when the drum is in a raised position. The apparatus described herein may have a measurement plate with sensors for determining the status of the blood culture bottles as the roller-shaped support moves past the measurement plate.As described throughout, the measurement plate may be placed near the outer perimeter of the roller-shaped support.

[0115] The above-mentioned device with locking means can have a locking means having a handle and a bracket. In the above-mentioned device, the lifter can have a screw that advances through a motor assembly support plate and a guide nut. The above-mentioned device operates so that when the roller-shaped support advances upward, the screw forces the plate upward. In the above-mentioned aspect, the plate advances upward along the guide pin. In this aspect, the plate advances upward and the roller-shaped support is lifted off the roller support, thereby creating a lifting space between the frame and the rotor of the drive motor.

[0116] In the present description, the word "comprising" is to be understood in its "open" sense, i.e. in the sense of "including", and is therefore not limited to its "closed" sense, i.e. in the sense of "consisting only of". A corresponding meaning belongs to the corresponding words "comprises", "comprising" and "having" where they appear.

[0117] Although specific embodiments of the 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, the present embodiments and examples are to be considered in all respects as illustrative and not restrictive.

[0118] It should be further understood that any reference herein to subject matter known in the art is not intended to be an admission that the subject matter is generally known to those skilled in the art, unless otherwise indicated.

Claims

1. A device for storing and monitoring blood culture bottles, the device comprising: a frame defining at least one cabinet adapted to receive therein a drum-shaped support having an outer periphery and an inner periphery, the outer periphery having a diameter exceeding a diameter of the inner periphery, the drum having a 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 section and a neck section, wherein the bottle is receivable by the receptacle such that the bottom section is received at the distal end of the receptacle or the neck section is received at the distal end of the receptacle; wherein the periphery of the drum is arranged around the rotation axis of the drum; wherein the plurality of receptacles are disposed in the drum in an array of receptacles, the array having receptacles arranged vertically and horizontally, vertically aligned receptacles forming columns, and horizontally aligned receptacles forming rows; a molded foam insert heat distribution assembly in each cabinet, the molded foam insert assembly comprising molded foam inserts assembled together; wherein each molded foam insert heat distribution assembly is in fluid communication with a heater / blower assembly; and The frame is arranged in the housing.

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

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

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

5. The device according to any one of claims 1 to 4, wherein the duct outlet is directed towards a receptacle in the drum-shaped support.

6. The apparatus of any one of claims 1-4, wherein the heater / blower assembly is supported by a frame above a cabinet in which the molded foam insert heat distribution assembly is placed or below a cabinet in which the molded foam insert heat distribution assembly is placed.

7. The apparatus of any one of claims 1-6, wherein the heater / blower assembly is disposed in a housing.

8. The apparatus of any one of claims 1-7, wherein the frame includes handles and tracks to advance the heater / blower assembly into and remove it from the housing.

9. An apparatus for storing and monitoring blood culture bottles, the apparatus comprising: a drum-shaped support having an outer periphery and an inner periphery therein, the outer periphery having a diameter exceeding a diameter of the inner periphery, the drum-shaped support having a 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 section and a neck section, wherein the bottle is receivable by the receptacle such that the bottom section is received at the distal end of the receptacle or the neck section is received at the distal end of the receptacle; wherein the periphery of the drum is arranged around the rotation axis of the drum; wherein a drive motor is positioned within said inner periphery of said drum-shaped support in alignment with said axis of rotation; and A drum motor encoder is rigidly coupled to the shaft of the motor shaft of the drive motor.

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

11. The apparatus of claim 9 or 10, wherein the apparatus further comprises a bottle presence sensor, the bottle presence sensor detecting the presence of a bottle in the receptacle.

12. Apparatus according to any one of claims 9 to 11, wherein the bottle presence sensor is adapted to detect an aligned state of the drum and a misaligned state of the drum.

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

14. The apparatus of any one of claims 9-13, wherein the drum motor encoder provides feedback to an operator when the operator manually moves the drum support.

15. The apparatus of any one of claims 9-14, wherein the drum motor encoder increments manual movement of the drum support so that the drum support advances a predetermined number of rotations when manually rotated.

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

17. Apparatus according to any one of claims 9 to 16, wherein the drum-shaped support comprises a lifter for raising the drum relative to the motor.

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

19. The apparatus according to any one of claims 9 to 18, wherein the apparatus further comprises a measurement plate comprising sensors for determining the status of the blood culture bottles as the roller-shaped support moves past the measurement plate.

20. The apparatus according to any one of claims 9 to 19, wherein the measurement plate can be placed near the outer periphery of the drum-shaped support.

21. The apparatus of any one of claims 18-20, wherein the locking tool comprises a handle and a bracket.

22. The apparatus of any one of claims 17-21, wherein the lifter comprises a screw that advances through a motor assembly support plate and a lead nut.

23. The apparatus according to any one of claims 17 to 22, wherein: When advancing upward, the screw forces the plate upward.

24. The apparatus of claim 23, wherein the plate travels upwardly along guide pins.

25. The apparatus of claim 24, wherein as the plate travels upwardly, the roller-shaped brackets are lifted off roller supports, thereby creating a lift space between the frame and the rotor of the drive motor.

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