High density bottle drum and storage method for storing, agitating and reading blood culture bottles

Abstract

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

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of priority of U.S. Provisional Application No. 62 / 883,796, filed on August 7, 2019, which is incorporated herein by reference.

[0002] The present invention relates to a non - invasive device for detecting biological activity in specimens such as blood, where many specimens are introduced into a very large number of sealed containers together with a culture medium and are exposed to conditions that allow for the occurrence of various metabolic, physical, and chemical changes in the presence of microorganisms in the sample. Next, a Colorimetry (c o lorimetric) sensor or a fluorescent chemical sensor disposed at the bottom inside each blood culture bottle is used to monitor these changes as the bottle rotates within a rotary drum. Once the monitoring is complete, the device performs an "automatic unloading" and also classifies the final negative and final positive bottles.

Background Art

[0003] The presence of biologically active agents such as bacteria in a patient's body fluid, particularly blood, is usually determined using blood culture bottles. A small amount of blood is injected through a sealed rubber septum into a sterile bottle containing a culture medium, and then the bottle is incubated at about 35°C and the growth of microorganisms is monitored.

[0004] Since it is of utmost importance to know whether a patient is infected with bacteria, hospitals and laboratories have automated devices that can process many blood culture bottles simultaneously. An example of such a device is the BD BACTEC™ system, manufactured and sold by Becton, Dickinson and Co. U.S. Patent No. 5,817,508 to Berndt et al. describes a prior art blood culture device 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.

[0005] Referring to FIG. 1, a mixture 22 of culture medium and blood sample is introduced into a sealed glass bottle 1, which contains photochemical sensing means 20 on their inner bottom surface 21. The photochemical sensing means 20 emits different amounts of light depending on the amount of gas in bottle 1. For example, the gas detected by the light sensing means 20 may be carbon dioxide, oxygen, or any gas that increases or decreases depending on the presence or absence of microorganisms growing in bottle 1.

[0006] As shown in FIGS. 1 and 2, a plurality of such bottles 1 are radially arranged on top of the bell-shaped rotating drum 2 within the incubator 5 in such a way that the bottom of the bottle 1 is oriented towards the drum axis 28. The bell-shaped drum 2 is hollow and is supported by a shaft 24 whose one end is rotatably supported by two large ball bearings 3 and 4 attached to the first side 51 of the main equipment frame 50. In order to read the information coming from the individual photochemical sensing means 20 within the bottle 1, a linear array 12 of sensor stations is mounted inside the bell-shaped rotating drum 2, slightly spaced from the second side 52 of the main equipment frame 50 within the bell-shaped rotating drum 2, such that during rotation of the drum 2, the individual bottles 1 pass through the respective sensor stations 15 of the array 12. The individual sensor stations 15 of the linear array 12 of sensor stations are equipped with an excitation light source 11 and the light collecting end of the optical fiber 14.

[0007] The axis 28 of the bell-shaped drum 2 is horizontally oriented and parallel to the door 13 arranged on the front face of the incubator 5 as shown in FIG. 2. By orienting the axis 28 horizontally, maximum agitation of the liquid culture medium and specimen mixture 22 and gas within the individual bottles 1 is provided. During the loading or unloading operation, the door 13 is open and access can be obtained simultaneously to approximately one third of all the bottles 1. Next, the drum 2 rotates until the next third of the bottles 1 becomes accessible. Access to all the bottles 1 can be obtained in three steps.

[0008] Alternatively, the axis 28 of the bell-shaped drum 2 is vertically oriented and slightly inclined by approximately 20 degrees from the door 13. In order to maintain optimal growth conditions, the inclination angle can be adjusted as necessary, thereby modifying the degree of agitation.

[0009] During operation, the bell-shaped drum 2 is rotated by the electric motor 6 and the belt 7. The circular member 8 and the sensor 9 form an angle encoder that provides information regarding the row of bottles 1 passing through the sensor station array 12. The electric motor 6 is preferably a stepper motor that can rotate the drum 2 in continuous mode or stop the drum 2 at an appropriate angle for reading from the sensing means 20 within the bottle 1 in steady state mode. The entire system is controlled by a control system 10 disposed inside the rotating drum 2. The output ends of all the optical fibers 14 of the linear array 12 of sensor stations are connected to one common optical detector (not shown) within the control system 10 such that there is only one excitation light source 11 that needs to be turned on at a time. Thus the control system "knows" from which detection station 15 and thus from which bottle 1 the sensor light is being collected.

[0010] The apparatus shown in FIGS. 1 and 2 includes 10 segments of blood culture bottles 1, with 36 bottles 1 per segment. Thus a total of 360 bottles can be accommodated. The arrangement of the bottles 1 on this drum 2 provides a relatively high package density, but there is still a need for density improvement. SUMMARY OF THE INVENTION

[0011] As used herein, an apparatus for storing and monitoring blood culture bottles is described. The apparatus has a movable rack configured as a drum having a plurality of receptacles therein for receiving blood culture bottles. The drum is disposed within a housing. The housing includes a heater and a blower for maintaining the blood culture bottles at an elevated temperature. The apparatus optionally has a plurality of drums, and each individual drum has a plurality of receptacles for receiving blood culture bottles.

[0012] A blood culture bottle typically has a bottom portion that is the larger volume of the bottle and a neck portion that is the narrower top portion of the bottle. The drum receptacle can be configured to receive the blood culture bottle either bottom-inward (bottom-in) or neck-inward (neck-in). In the bottom-in configuration, the receptacle is typically angled downward such that the culture bottle is held at an angle of 20° from horizontal upward. However, the culture bottle can also be held horizontally (i.e., the neck portion is not angled upward or downward relative to the bottom portion), and an accurate measurement of the contents of the blood culture bottle can be obtained to determine whether the contents are positive for microbial growth. To obtain a high density of bottles, the drum is configured to rotate about an axis with a circular drum rack coaxial with the axis of rotation. When the culture bottle is placed into the drum from the bottom side, the electronic circuitry for monitoring the blood culture bottle is disposed inside the drum. When the bottle is placed into the drum from the neck end, some of the measurement electronic circuitry is disposed outside the drum.

[0013] The drum is formed in a modular fashion. The drum has a plurality of rows of receptacles and a plurality of columns of receptacles. In one configuration, the rows of receptacles are formed by obtaining a molded article that is the upper and lower portions of the row. The molded articles are assembled to form one row of the drum, and a plurality of rows are assembled together to form the drum. Optionally, the receptacles are aligned vertically within the assembled drum. Optionally, the receptacles are staggered within the assembled drum to provide a drum with a higher bottle density.

[0014] The drum has both an outer perimeter and an inner perimeter. The receptacles receive the culture bottles therein, and the receptacles extend from a first perimeter to a second perimeter. The receptacles are evenly disposed in rows that move along the perimeter of the drum.

[0015] In these embodiments where the drum receptacle receives the bottle at neck-in, the receptacle includes a mechanism for holding the bottle within the receptacle. This mechanism may be a spring clamp, a cap clamp, a leaf spring or a stop. With such a mechanism, the culture bottle can be securely held within the drum while the drum is operating.

[0016] Described herein is an apparatus for storing and monitoring blood culture bottles. The apparatus has a housing with a drum therein. The drum has an outer perimeter and an inner perimeter. The outer perimeter has a diameter larger than the diameter of the inner perimeter. The drum has a plurality of receptacles, these receptacles having proximal ends at the outer perimeter and distal ends at the inner perimeter, and the individual receptacles are configured to receive a blood culture bottle. The blood culture bottle has a bottom portion and a neck portion, and the bottle is received by the receptacle either with the bottom portion received at the distal end of the receptacle or with the neck portion received at the distal end of the receptacle.

[0017] The drum perimeter is disposed about the axis of rotation of the drum. A plurality of receptacles are disposed within the drum as an array of receptacles, the array having receptacles disposed in both the vertical and horizontal directions. The apparatus also has a sensor and a detector for inspecting the blood culture bottle to determine whether the blood culture bottle is positive or negative for microbial growth. The drum defines an internal space within the inner perimeter, and at least a portion of the drum electronics that communicate with the sensor and detector for inspecting the blood culture bottle are disposed at the inner perimeter of the drum.

[0018] Optionally, each of these multiple receptacles has a respective elastomeric insert for receiving a culture bottle. Optionally, each of these multiple receptacles receives the neck portion of the culture bottle at its distal end, and each individual receptacle comprises a bottle stop and a canted coil spring spaced from the bottle stop. The canted coil spring is biased and allows a cap disposed on the neck portion of the bottle to pass through the canted coil spring and bear against the bottle stop, whereby the canted coil spring releases tension and secures the culture bottle within the receptacle.

[0019] Optionally, each of these multiple receptacles receives the neck portion of the culture bottle at its distal end, and each individual receptacle comprises a bottle stop and an O-ring spaced from the bottle stop. The O-ring is sufficiently elastic and allows a cap disposed on the neck portion of the bottle to pass through the O-ring and bear against the bottle stop. The O-ring then releases tension and secures the culture bottle within the receptacle.

[0020] Optionally, each of these multiple receptacles receives the neck portion of the culture bottle at its distal end, and each individual receptacle has a bottle stop and a ball plunger spaced from the bottle stop. The ball plunger is biased and allows a cap disposed on the neck portion of the bottle to pass through the ball plunger and bear against the bottle stop. The ball plunger then releases tension and secures the culture bottle within the receptacle.

[0021] Optionally, a plurality of these receptacles each receive the neck portion of the culture bottle at their distal ends, and each individual receptacle comprises a bottle stop and a split retaining portion spaced from the bottle stop. The split retaining portion is biased to allow a cap disposed on the neck portion of the bottle to pass through the split retaining portion and bear against the bottle stop. The split retaining portion releases tension to secure the culture bottle within the receptacle. Optionally, the split retaining portion is integrally pushed by a cantilevered coil spring, or the split retaining portion is an elastic segment. Optionally, a plurality of these receptacles each receive the neck portion at their distal ends, and each individual receptacle has a bottle stop and a plurality of elastic wings extending from the bottle stop. The wings are biased to allow a cap disposed on the neck portion of the bottle to pass over the flange portion of the wings and bear against the bottle stop. The wings release tension and the flange portion secures the culture bottle within the receptacle. Optionally, each of these receptacles having elastic wings has a ball plunger. The bottle stop has a notch. As the culture bottle advances into the bottle stop, the bottle stop further advances into the receptacle until the ball plunger aligns with the notch, thereby securing the bottle stop within the receptacle.

[0022] Optionally, a plurality of these receptacles have notches, and the bottle stop has a ball plunger. As the culture bottle advances into the bottle stop, the bottle stop further advances into the receptacle until the ball plunger aligns with the notch, thereby securing the bottle stop within the receptacle.

[0023] Optionally, these multiple receptacles have a tray portion, on which a culture bottle is placed. The tray portion has tabs for fixing the bottom of the culture bottle into the tray. The receptacle also has a stop portion. The stop portion positions the culture bottle at a predetermined fixed position within the receptacle. The stop portion may be one of a leaf spring, a deformable material, and / or a pivot arm that pivots as it advances into the receptacle of the culture bottle to fix the culture bottle within the receptacle. The stop portion may be made of an elastic material selected from one of an elastomeric flexible tubular material, an elastomeric material, or a foamed material.

[0024] Optionally, the tray portion of the receptacle forms a light pipe that transmits an optical signal from an indicator LED disposed within the perimeter of the inside of the drum to the outside of the drum as can be seen from The bottle stop may also be a keyhole element. Optionally, the outer perimeter of the drum and the inner perimeter of the drum are circular.

[0025] This specification describes a method for controlling an incubator for a plurality of blood culture bottles. In this way, an operator inputs a predetermined sector of a blood culture drum via a control interface. The blood culture drum is a rack that defines a substantially circular inner perimeter and a substantially circular outer perimeter. The blood culture drum is rotatable. The door of the housing for the blood culture drum is opened by the operator, and the drum is typically stopped by reducing the power to the electric motor used to rotate the drum so that access to a predetermined sector can be made through the open door of the housing. The blood culture drum has a plurality of receptacles, and each of these plurality of receptacles is adapted to receive and hold a blood culture bottle. Each of these plurality of receptacles has an indicator at its proximal end. The indicator provides an indication as to whether the culture bottle in the receptacle is positive or negative for microbial growth. The blood culture bottle is either inserted into an empty receptacle among the plurality of receptacles, removed from one of the plurality of receptacles, or after being removed from one of the plurality of receptacles, another blood culture bottle is inserted in its place. The blood culture bottles are removed based on their indicated status.

[0026] Optionally, each receptacle has a light pipe extending from the proximal end of the receptacle to the distal end of the receptacle. Optionally, the control interface communicates with an encoder such that the control interface tracks the placement of individual blood culture bottles within the rack. Optionally, the incubator further comprises a reading station, and when the bottle drum rotates a receptacle carrying a blood culture bottle past the reading station, the reading station determines the status of the blood culture bottle. Optionally, indicator LEDs are disposed at the distal ends of at least some of the receptacles within the bottle drum. As mentioned somewhere herein, the culture bottles are received within each of the plurality of receptacles either neck-in or bottom-in. Thus, the receptacles are configured to receive the culture bottles either neck-in or bottom-in.

Brief Description of the Drawings

[0027]

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DETAILED DESCRIPTION OF THE INVENTION

[0028] In this specification, a blood culture device configured as a heat insulation and measurement module is described. The heat insulation and measurement module can optionally integrate a larger end-to-end solution for processing biological samples and determining whether such samples contained therein are contaminated with microorganisms or infected with microorganisms. The modules described in this specification can be placed in a cabinet as shown in FIGS. 3A and 3B. Cabinet 200 can supply power to the modules, provide a controlled thermal environment to the modules, and also provide a communication channel to the modules. FIG. 3A shows a cabinet 200 having two 3-door panels 201, and the two 3-door panels 201 provide access to three bottle drums on both sides of the central panel 202. The central panel 202 has a touch screen 203 for data input and User control (use r control). The central panel 202 also has a central station 204 for loading / unloading culture bottles. FIG. 3B shows a cabinet having only one 3-door panel 201.

[0029] The module has a high-density bottle drum. As used herein, high density describes a drum configuration in which culture bottles can be placed closer together, thereby allowing more bottles to be stored in the drum compared to the prior art. The module is configured to align the bottles with a limited number of reading stations. That is, the number of reading stations is less than the number of bottle receptacles in the drum. Optionally, the drum is operated by a direct drive electric motor that can accelerate and decelerate the drum (i.e., rocking motion, intermittent rotation, etc.). A heater and a blower are provided inside the drum housing. The heater and the blower circulate warm air around the drum. Optionally, the heater and the blower are configured to maintain the temperature of the contents of all the culture bottles in the drum within a predetermined narrow range of a specific target temperature. The predetermined narrow range is ±1.5 °C of the target temperature. The specific target temperature ranges from 30 °C to 40 °C. Optionally, the target temperature is 35 °C. The higher the temperature uniformity, the higher the set value can be because the risk of the sample "overheating" is reduced. Therefore, the higher the temperature uniformity at high temperatures, the faster the detection time can be. The motor can position the drum so that a user or an automated device can access any bottle that the drum is carrying. When it is determined that the sample in the bottle is positive for microbial growth, a workflow is initiated to retrieve that culture bottle from the module. The module is configured to assist that workflow.

[0030] The module is configured to have an LED and a light pipe for indicating (showing) positive culture bottles to the user. Referring to FIG. 4, a top view of an optional configuration of the module described herein is shown. Module 210 has a housing 224, a blower and a heater 225 for keeping the bottles 230 warm, and a drum 240 with receptacles for holding the culture bottles. Inside the drum are measurement electronic circuits 250 and the culture bottles Detection / The indicator electronic circuit 260 is arranged. A drive motor 270 for rotating the drum 240 is provided. The drum 240 housing 224 has six panels 221 that define six drum sectors (222A to 222F). As shown, the span of one sector is approximately the same as the span of the opening in the housing where bottles are added to or removed from the drum 240, so that approximately one-sixth of the drum contents (assuming the drum is full) can be utilized to access at any given time. FIG. 5A is a cutaway side view of the drum of FIG. 4. The culture bottle 230 is arranged with its neck inwardly in the receptacle 220 within the drum 240. The motor 270 is a direct drive motor with high torque, little or no hysteresis, low noise, high reliability, and simplicity.

[0031] FIG. 5B is a cross-sectional view of a thermostatic and measuring module drum having a stepper motor and a gearbox. Alternatively, if the appropriate size and spacing between the internal gearbox bearings cannot be achieved within the limited space constraints inside the drum, it is also possible to include an additional bearing set towards the bottom of the drum ring.

[0032] As shown in FIG. 5A, the motor drives the drum to rotate axially. The bearings inside the gearbox of the motor 270 provide axial alignment for both ends of the drum 240, and also provide the necessary thrust load support required to advance the drum carrying a significant number of bottles 230. Alternatively, if it is not possible to achieve the appropriate size and spacing between the internal gearbox bearings within the limited space provided inside the drum perimeter, it is also possible to include an additional bearing set towards the bottom of the drum ring. The mechanism for rotating the drum 240 around the axis is well known to those skilled in the art and will not be described in detail herein. This structure and bearing configuration can also be adapted to other drum configurations (e.g., drums that receive culture bottles by neck-out instead of neck-in, drums with receptacles angled upwards, etc.). Optionally, the measurement electronic circuit, status indicator, and bottle detection electronic circuit are all supported by a single shaft 285.

[0033] In FIG. 5A, a rotary actuator, a hollow rotary actuator, or a stepper motor with a gearbox is used to combine the bearing function and the motor function into one component. An example of such a suitable motor actuator is shown in FIG. 6. FIG. 6A shows a hollow rotary actuator 294 having a motor 296 that drives a pinion gear 297. When the pinion gear 297 rotates, the drum gear 298 rotates the output table 239, thereby rotating the drum 240 (not shown). FIG. 6B shows a rotary actuator 299 that directly rotates the drum 240 (not shown). Other examples of suitable motors with gearboxes are contemplated. Such motors can be directly attached to the gearbox (usually at the factory). Such a gearbox can reduce the motor speed while increasing the torque of the output shaft. The output shaft can be mechanically attached to a circular spacer block having an attachment point suitable for interfacing with the drum attachment point.

[0034] Figure 5B shows the culture bottle 230 disposed at an angle of 20° from horizontal and upward within the drum 240. One skilled in the art will note that a sensor (not shown) within the culture bottle must be completely covered by the medium during reading. Other angles that meet these criteria are contemplated, but the bottle angle must also accommodate a high-density design. One embodiment can include a top bearing 290 near the top of the drum (240), and can also include a second bearing 290 towards the bottom of the drum 240. Optionally, the first (top) bearing is a thrust ball bearing, and the second (lower) bearing is a spherical bearing to accommodate any non-coaxial relationship between the first and second bearings. These structures and bearing configurations can also be adapted to other drum configurations (e.g., a drum that receives the culture bottle by neck-in instead of neck-out). The electric motor 270 is a high-torque, low or no hysteresis, low-noise, high-reliability, and simple direct-drive electric motor. As shown in Figure 5B, a single shaft 285' supports the bottle drum 240 and the drive electric motor 270. The two bearings 290 between the shaft 285 and the drum 240 are similar to the two bearings that support the rotor of prior art equipment. The distance between these two bearings can be made long to minimize the movement of the inner surface of the bottle drum relative to the shaft. These structures and bearing configurations can also be adapted to other drum configurations (e.g., a drum that receives the culture bottle by neck-in instead of neck-out). Optionally, the measurement electronic circuit, status indicator, and bottle detection electronic circuit are all supported by a single shaft 285.

[0035] An alternative embodiment disposes a top mounting ring bearing smaller than the ring bearings in prior art systems that guide drum rotation. A ring bearing 700 is shown in Figure 25. A bottom mounting ring bearing 600 is shown in Figure 23. One skilled in the art will recognize that the bearing 290 can be replaced with a ring bearing to support the drum from the top, and this ring bearing is attached to the module housing 224.

[0036] Referring to FIG. 7, the bottle drum 240 is structured to hold the culture bottles 230 packed tightly with their necks facing outward. The culture bottles 230 are arranged in alternating layers 241, 242 (FIG. 8) with their necks facing outward from the drum 240 to achieve tight packing. FIG. 9 is a perspective view of the alternating drums shown in FIG. 8 in a frame configured for the 3-door cabinet shown in FIGS. 3A and 3B. The alternating culture bottle arrangement also provides space above each individual culture bottle for labeling the culture bottle receptacles 220 or detecting the output of the light-piped Indicator 295 (FIG. 5B). Each individual bottle receptacle 220 will have a number indicating its horizontal position within the drum and a status indicator to guide the user through the manual workflow.

[0037] Referring to FIG. 10, the bottles 230 (facing inward) within the drum 240 are placed within one of six sectors (222A - 222F) within the module 210. These sectors are defined by vertical panels 221 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 fully shield the user from the inside of the module when a section of the culture bottles is accessed by the user. The module 210 also includes a blower and heater 225 to keep the bottles 230 warm. Inside the drum are measurement electronic circuits 525 and culture bottle / Detection electronic circuits 260 are arranged. A drive electric motor 270 is provided to rotate the drum 240.

[0038] Referring to FIG. 11, the bottle drum 240 has a receptacle 220 for receiving culture bottles that are necked-in in the layers described above (in layers). The receptacle 220 has a light pipe formed at the bottom portion of the receptacle, and the bottom portion of the receptacle also defines the bottom edge of the receptacle. These features are described somewhere in this specification. In FIG. 12, one bottle drum has been removed from the 3-door cabinet 200 described in FIG. 3. As shown in FIG. 11 There are 24 receptacles 220 that will receive 24 bottles 230 per layer 231, there are 8 layers 231 per drum 240, and there are 3 drums 240, so the bottle capacity is approximately 576. Optionally, the module has a receptacle for receiving necked-out bottles. In one embodiment, the drum will have 30 receptacles per layer, 8 layers per drum, and 3 drums, so the bottle capacity is approximately 720.

[0039] FIG. 14 shows a drum formed from injection molded layers 320A and 320B. When assembled together, the injection molded layers cooperate to form a single layer 330 of the drum 240. In the embodiment of FIG. 14, the molded layers 320A and 320B, when joined together, form a honeycomb stack of receptacles 220, providing a bottle density that is approximately 20 percent higher to the drum 240. Optionally, the injection molded layers are shaped to have discrete retention features, cavity features or other features provided to facilitate the receipt, retention and release of culture bottles within the receptacles. By molding receptacles with such features, the number of discrete parts is reduced and the manufacturing process is simplified.

[0040] The drum can also be assembled in a vertical section. Referring to FIG. 15A, a bottle drum 240 (similar in appearance to the drum shown in FIG. 13) is assembled in a vertical section 248 of the bottle receptacle. The vertical section 248 forms linear rows and columns of the bottle receptacle 220 together with the bottles 230 inserted by necking-in. Referring to FIG. 15B, a drum 240 (similar in appearance to the drum shown in FIG. 14) is assembled from a vertical section 249. The vertical section 249 forms linear columns of the bottle receptacle 220, but the rows providing the higher-capacity drums 240 are staggered. The vertical sections can be formed by injection molding. The plurality of vertical sections are connected or attached to a central ring. Optionally, the injection-molded layer is shaped to have discrete holding features, cavity features, or other features provided to facilitate the receipt, holding, and release of the culture bottles within the receptacle. By molding a receptacle having such features, the number of discrete parts is reduced and the manufacturing process is simplified.

[0041] In the case of a neck-in drum configuration, the culture bottle receptacle requires a mechanism for holding and releasing the culture bottle. FIGS. 16A and 16B show a drum 800 assembled with a vertical segment 805 instead of the horizontal segment as shown in FIG. 13. As mentioned above, the vertical segment 805 has at least one bottle receptacle 810 in individual rows. However, as shown in FIGS. 16A and 16B, the vertical segment 805 can also have multiple bottle receptacles 810 in individual rows. The bottle receptacle 810 is configured to receive a bottle 830 having a narrow neck portion 835 and a wider bottle portion 840. Thus, as shown, the bottle receptacle 810 has an outer portion 845 with a diameter sufficient to receive the bottle portion 840 of the bottle, and a narrower inner portion 850 with a diameter sufficient to receive the neck portion 835. As described elsewhere herein, there are many bottle holding mechanisms contemplated herein. FIGS. 16A and 16B show a bottle receptacle 810 having an elastomeric insert lining 855 within the bottle receptacle 810. The elastomeric insert lining 855 has a first flange 860 for holding the elastomeric insert 855 within the bottle receptacle 810. The elastomeric insert lining 855 has a second flange 865 disposed in the narrower inner portion 850, such that when the bottle 830 is inserted into the receptacle 810, the second flange 865 fits within the receptacle between a cap 870 provided on the bottle 830 and the neck portion 835 of the bottle 830. The second flange 865 holds the bottle 830 within the receptacle 810, but the force by which the second flange 865 holds the bottle 830 within the receptacle 810 can be easily overcome when the bottle 830 is removed from the bottle receptacle 810 of the drum 800.

[0042] Referring to FIGS. 17A - C, a cantilever coil spring 400 sized to grip a crimp ring cap 410 of a culture bottle 230 is disposed at the distal end 415 of a bottle receptacle 220. When a user pushes the culture bottle 230 into the bottle receptacle 220, thereby pressing the crimp 410 of the culture bottle past the cantilever coil spring 400 to hold the culture bottle 230 within the bottle receptacle 220. The bottom 416 of the culture bottle 230 extends outwardly from the proximal end 420 of the bottle receptacle 220, and thus a user or robot can grasp the bottom 416 of the culture bottle to remove the culture bottle. FIGS. 17A - C show the same mechanism in different views. All have the same cross - section. FIG. 17A shows the entire bottle receptacle 220 with the culture bottle 230 therein. FIG. 17B is a detailed plan view of the distal end 415 of the bottle receptacle 220, and FIG. 17C is a detailed perspective view of the distal end 415 of the receptacle 220. FIG. 29 shows one row of drums formed from the receptacles shown in FIGS. 17A - C. Drums formed from such receptacles are not fully circular but are faceted.

[0043] Optionally, the crimp cap 410 is a deformable metal (e.g., aluminum) cap having a septum in the center. Referring to FIG. 27, the top view of the cap shows a metal crimp perimeter 411 having a metal crimp 412, and the metal crimp 412 is slightly recessed from the metal crimp perimeter 411. The crimp cap 410 can carry (bear) a mark 413 that provides information to the operator or user regarding the state of the culture bottle on which the cap is provided (i.e., whether it is positive or negative for microbial growth). To apply a status indication (display) mark to the crimp cap, the blood culture bottle is pushed into a cavity having a raised symbol on its bottom, and the raised symbol is, in the illustrated embodiment, a + symbol indicating that the system has determined that the culture bottle is positive for microbial growth. As shown, the mark 413 is aligned with the flat portion of the metal of the crimp seal. When the cap is pressed onto the raised symbol, a trace of the mark 413 is left (imprinted) on the crimp seal.

[0044] FIG. 29 shows a drum 240 having the receptacles shown in FIGS. 17A - C. one layer of The drum shown in FIG. 29 has a faceted external and internal perimeter for integration of the receptacles. The receptacles having coil springs can be closely spaced vertically. By using these receptacles to form the drum, significant height savings can be provided (e.g., about 50 mm). In embodiments where multiple drums are placed within a single cabinet, the cabinet size can be made more compact and more easily accessible to the user. Also, because of the low height of the drum, more electronic circuits can be placed in the top and bottom portions of the incubation and measurement cabinet. FIG. 29 shows a single row of receptacles 220. As described herein, the drum is assembled in multiple rows that are integrally connected to form the drum 240.

[0045] The bottom 416 of the culture bottle (Figure 17A) Since it extends from the receptacle 220, the culture bottle may obscure the station indicator on the proximal surface 463 of the receptacle 220 when viewed from the bottle receptacle or from below the bottle receptacle. To address this potential problem, a station indicator light pipe (not shown) extends from the distal end 415 to the proximal end 463 of the receptacle. Optionally, the culture bottle receptacle 220 can be sized so that the culture bottle fits completely within the receptacle 220, but the proximal end of the receptacle has an extension adjacent to or is scored at the bottom of the culture bottle to provide grip access for the user or robot.

[0046] Another issue to consider is an important characteristic regarding the position of the bottom of the bottle relative to its measurement optical system and electronic circuitry. The cantilevered coil spring must pull the bottle to a hard stop so that the bottle base does not move in any direction while the bottle drum is rotating or while the user is touching the bottle in a manual workflow.

[0047] Figures 17D - F show an alternative retention mechanism having a ball plunger 474 disposed in the narrower portion 850 of the bottle receptacle 220. Referring to FIG. 17D, the ball plunger 474 is biased outwardly by a spring arm 476 and has a ball 471 extending into the narrower portion 850 of the bottle receptacle 220. In FIG. 17D, the ball plunger 474 is shown from the distal end of the bottle receptacle 220, which is the distal end of the narrower portion 850 of the bottle receptacle 220. Referring to FIG. 17E, as the culture bottle 230 advances into the narrower portion 850 of the bottle receptacle 220, a ball 471 extending outwardly into the narrower portion 850 of the bottle receptacle 220 is shown. Referring to FIG. 17F, as the culture bottle 230 advances further, the crimp ring cap 410 of the culture bottle 230 pushes the ball 471 back into a passage 472 formed in the narrower portion 850 of the bottle receptacle 220. As the crimp ring cap 410 of the culture bottle 230 advances beyond the ball 471 of the ball plunger 470, the ball 471 advances into a space 472 formed between the crimp ring cap 410 of the culture bottle 230 and the neck 835 of the culture bottle 230 by the biasing force applied to the ball 471. This biasing force secures the culture bottle 230 within the bottle receptacle 220. When the culture bottle 230 is removed from the bottle receptacle, the biasing force of the ball plunger 474 is overcome, and thus the crimp cap 410 of the culture bottle 230 can pass beyond the ball plunger 474 and be removed from the bottle receptacle 230.

[0048] FIG. 17G shows the alternative receptacle 220, with the O-ring 461 engaged with the stop 462 directly below the cap 410 of the culture bottle 230. Conventional O-rings are contemplated and may be made of materials such as Viton™, silicone, or other conventional elastomeric materials. Such materials are well known to those skilled in the art and will not be described in detail herein. As shown in FIG. 17G, the receptacle 220 receives only a portion of the culture bottle 230 and terminates at 463 (substantially the transition portion from the neck 435 of the culture bottle to the bottom portion 416 of the culture bottle 230). In this way, if the culture bottle is distorted from its desired position, it can be easily observed even if the culture bottle is not properly seated in the receptacle for that reason.

[0049] Figures 18A - C show modified forms of the cantilever coil spring shown in FIG. 17. FIG. 18A is a perspective view of the holding cap on the bottle. FIG. 18B is a cutaway view of the cap of FIG. 18A. FIG. 18C is a perspective view of the divided holding mechanism of FIG. 18A as viewed from above. Referring to FIG. 18A, the holding mechanism 431 has a plurality of wedges 430A - C that translate radially to receive the neck 435 of the bottle 230 and the crimp ring cap 410 (FIG. 18B). Although three wedge sections 430A - C are shown, a different number of plural sections are contemplated. The wedge sections 430A - C are placed at the distal end of the thinner portion 850 of the culture bottle receptacle 220 in the drum. The crimp ring cap 410 attached to the neck 435 of the bottle 230 fits into the widened proximal end 440 of the holding mechanism 431. The proximal end 440 of the holding mechanism 431 widens to receive the crimp ring cap 410 of the bottle. The holding mechanism 431 has a stop flange 432, and thus the neck of the bottle 435 can only advance into the holding mechanism 431 by a defined distance. The holding mechanism can move the wedges 430A - C radially in response to the insertion of the neck of the bottle into the holding mechanism, but the holding mechanism has a circumferential spring 433 that applies tension to ensure that the crimp ring cap 410 is securely held within the holding mechanism.

[0050] Figs. 19A - C show a modified form of the canted coil spring shown in Fig. 17. In this embodiment, the sectioned retaining mechanism 450 has gripping portions 460A - E separated by spaces 465. The gripping portions 460A - E are elastic, and the spaces 465 allow the gripping portions to apply a gripping force to the crimp ring cap 410 and the neck 435 of the bottle while expanding. Similar to the embodiment of Figs. 18A - C, the proximal end 470 of the retaining mechanism 450 is expanded to receive the crimp ring cap 410 and the neck 435 of the bottle. In one example, the elastic gripping portions 460A - E are made of ABS plastic. The individual sections 460A - E are curved radially to capture the crimp ring cap 410 and the neck 435 of the bottle. Although five sections are shown in Figs. 19A - C, this is for illustration purposes. Retaining mechanisms with different numbers of sections are contemplated.

[0051] Figures 19D - Q show other alternative retaining mechanisms. Figure 19D shows a slotted cap 451 having a slot 481 that locks the slotted cap 451 with a ball plunger 474 into the bottle receptacle 220. Tension is applied to the wing 482, and it has a flange 483 that functions almost the same as the second flange 865 shown in Figure 16B. Referring to Figure 19E, when the culture bottle 230 advances forward in the bottle receptacle 220, the wing 482 is biased outward and receives the neck portion 835 of the culture bottle 230. At this point, the slot 481 of the slotted cap 451 is not aligned with the ball 471 of the ball plunger. Referring to Figure 19F, when the culture bottle 230 further advances toward the distal end of the bottle receptacle 220, the thinner inner portion 850 of the bottle receptacle 220 tapers, and the thinner inner portion 850 pushes the wing 482 inward so that the flange 483 fits into the space between the crimp cap 410 and the neck 835 of the culture bottle 230. Also, the slotted cap 451 advances such that the slot 481 aligns with the ball 471 of the ball plunger and locks the slotted cap in a predetermined position in the bottle receptacle. To remove the culture bottle, one must overcome the biasing force of the ball plunger 474 and allow the crimp cap 410 to pass over the ball plunger 474, thereby enabling the bottle to be removed. Since the wing 482 of the slotted cap 451 is biased outward, the flange 483 disengages from the culture bottle 230 when the culture bottle advances outward from the receptacle 220.

[0052] Figures 19G - I show the ball plunger cap 452 within which the ball plunger 474 is formed. The ball plunger cap 452, when the ball plunger cap 452 is in the first unlock position and the second lock position, cooperates with slots 487A and 487B in the bottle receptacle 220 to lock the ball plunger cap 452 within the bottle receptacle 220. Tension is applied to the wings 482, and it has a flange 483 that functions almost the same as the second flange 865 shown in Figure 16B. Referring to Figure 19H, the cap 452 is in the first unlock position, and the ball plunger 474 is aligned with slot 487A. When the culture bottle 230 advances forward within the bottle receptacle 220, the wings 482 are biased outward and receive the neck portion 835 of the culture bottle 230. The slot 487B in the bottle receptacle 220 is not aligned with the ball plunger 474 at this point. Referring to Figure 19F, when the culture bottle 230 further advances toward the distal end of the bottle receptacle 220, the thinner inner portion 850 of the bottle receptacle 220 tapers, and the thinner inner portion 850 pushes the wings 482 inward so that the flange 483 fits into the space between the crimp cap 410 and the neck 835 of the culture bottle 230. Also, the ball plunger cap 452 advances such that the slot 487A aligns with the ball 471 of the ball plunger, thereby locking the ball plunger cap 452 in a predetermined position within the bottle receptacle. To remove the culture bottle 230, overcome the biasing force of the ball plunger 474 so that the assembly of the culture bottle 230 and the ball plunger cap 452 can advance to the first position, where the flange 483 is biased outward again to release the culture bottle 220. At the first position, the slot 487A in the bottle receptacle 220 aligns with the ball plunger 474 of the ball plunger cap 452 again, thereby holding the ball plunger cap 452 within the bottle receptacle when the bottle is removed from the culture bottle receptacle.

[0053] Figures 19J and 19K show how the bottle receptacle 220 shown in FIGS. 19G - I fits into the drum 240. In FIG. 19J, the bottle receptacle 220 is in a position aligned with the track 839 in the drum opening and has a slot 838 that advances into the opening in this alignment until the bottle receptacle 220 is fully disposed within the opening of the drum 24. Referring to FIG. 19K, the bottle receptacle 220 then rotates to lock the bottle receptacle 220 within the drum 240.

[0054] Figures 19L - 19Q show alternative bottle receptacles for the bottle receptacles shown in FIGS. 18A - C and 19A - C. Referring to FIG. 19L, a bottle holder 453 configured to be placed within the bottle receptacle has wings 841 and a cantilevered coil spring 842. Other spring - like members such as an elastomeric O - ring or a garter spring are also contemplated. The wings 841 can be pushed separately, overcoming the biasing of the cantilevered coil spring 842, and the neck 835 of the culture bottle advances into the bottle holder 453 as shown in FIG. 19M. When pushed separately, the wings 841 have grooves 491 that move along the track 492. The bottle holder 453 has a flange 483. When the crimp cap 410 of the culture bottle 230 advances past the flange 483, the biasing force of the cantilevered coil spring 842 pushes the wings to return together and pushes the flange to seat against the base of the crimp cap 410 to secure the culture bottle within the bottle receptacle as shown in FIG. 19N. Also in this case, the grooves 491 in the wings 841 allow the return movement of the wings along the track 492 to their closed positions. Since the cantilevered coil spring is not shown in FIGS. 19M and 19N, the movement of the wings from the pushed - open position in FIG. 19M to the closed position in FIG. 19N can be clearly seen.

[0055] Figures 19O - Q show a bottle holder 454 which is a deformed form of the bottle holder described in Figures 19L - N. Referring to Figure 19O, the bottle holder 454 configured to be placed in the bottle receptacle has wings 841 and a garter spring 842. The wings 841 can be pushed separately, overcoming the biasing force of the garter spring 842, and as shown in Figure 19P, the neck 835 of the culture bottle is advancing into the bottle holder 454. When pushed separately, the wings 841 have grooves 491 that move along the track 492. The bottle holder 454 has a flange 483. When the crimp cap 410 of the culture bottle advances past the flange 483, the biasing force of the garter spring 842 pushes the wings to return integrally and also pushes the flange to seat on the base of the crimp cap 410, fixing the culture bottle in the bottle receptacle as shown in Figure 19Q. Also in this case, the grooves 491 in the wings 841 allow the return movement of the wings along the track 492 to their closed positions. Since the garter spring is not shown in Figure 19P, the movement of the wings to the pushed - open position can be clearly seen.

[0056] Figures 20A - C show an alternative mechanism 500 for holding a bottle in a drum. The mechanism 500 uses a leaf spring 510 to fix the culture bottle 230 in the receptacle 220. In this configuration, the bottom 416 of the culture bottle is fixed in the receptacle by a tab 417. The holder 220 has an opening 418 so that the culture bottle 230 can be inserted into the holder 220 either manually or by a robotic grip and can also be removed from the holder 220. This allows access to the culture bottle 230 fixed in the drum receptacle 220. The user or robot pushes the bottle into the receptacle 220 until the leaf spring 510 pushes the bottle and the bottom 416 of the bottle falls in front of the tab 417. The leaf spring 510 stops the bottle 417It is held against. To remove the culture bottle 230, the user or robot pushes the culture bottle 230 away from the tab 417 so that the bottle 230 can be pulled out of the receptacle 220. If the culture bottle 230 is not fixed by the tab 417, the leaf spring 510 presses the culture bottle 230 towards the proximal end 420 of the receptacle 220 to facilitate recovery.

[0057] Referring to FIG. 21, the receptacle also has a light pipe 515 that transfers light from the indicator LED 520 from the distal end 525 of the receptacle (i.e., the inside of the drum 240 where the receptacle is located). The light pipe 515, if present, supports the bottle 230 and extends past the proximal end 420 of the receptacle (i.e., the outer surface of the drum 240). having a free end 535 The leaf spring 510 presses against the upper shoulder of the culture bottle 230 530 to hold the culture bottle 230 against the tab 417. The receptacle 220 is adjacent to the bottle detector 536 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 detector 536. The bottle detector 536 is borne by the stationary detector substrate 540. As shown in FIGS. 20B and 20C, the spring is embedded in the bottle holder 220.

[0058] The module includes a measurement electronic circuit 545 for each layer of bottles 230 in the individual drums 240. As shown in FIG. 20A, the measurement electronic circuit 545 is placed in front of the right corner of the module 210 (see FIGS. 4 and 10) outside the drum 240.

[0059] The light pipe 515 (FIG. 21) is in exact alignment with the indicator LED 520 on the substrate 540. 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 520. The bottle crimp cap 410, when placed in the receptacle 220, blocks the bottle detector 536 (e.g., an optical switch or proximity sensor). The indicator LED 520 and the bottle detector 536 are disposed on the substrate 540, which is located at a position corresponding to an individual bottle 230 within the drum 240 that is accessible to the user inside the drum 240. The bottle detector 536 is monitored to detect in real time the time when the bottle 230 is placed in the receptacle or the time when the bottle 230 is removed from the receptacle while the door to the module is open.

[0060] Referring to FIG. 20A, the user first places the bottle 230 into the receptacle 220 by inserting the neck of the bottle 230 until it contacts the leaf spring 510, and then presses the bottle 230 against the spring 510 until the bottom 416 of the culture bottle passes the tab 417 that holds the bottle 230 within the receptacle 220. The leaf spring 510 engages the culture bottle 230 such that if the user has not fully inserted the culture bottle 230 into the receptacle 220, the leaf spring 510 prevents the culture bottle 230 from fully seating within the receptacle 220. As a result, the culture bottle 230 will extend far enough from the station so that the drum 240 cannot advance the culture bottle 230 past the module housing 224. This allows the module 210 to detect an unseated bottle 230 when the user closes the door of the module. To remove the bottle 230 from the receptacle 220, the user simply lifts the bottom 415 of the culture bottle over the tab 417 and pulls the culture bottle 230 out of the receptacle 220. In embodiments where the insertion and removal of the culture bottle is automated, the same movement is performed by an automated device.

[0061] Referring to FIG. 20C, the receptacle 220 with some modifications is shown in more detail. The receptacle 220 is made of a transparent material and can thus be used as a light pipe to transfer light from the receptacle status indicator LED 520 inside the drum 240 to the proximal end 420 of the receptacle 220 outside the bottle drum 240.

[0062] The leaf spring 510 attached to the top of the receptacle 220 curves from the position shown in FIG. 20C to the position shown in FIG. 20A when the culture bottle 230 is received into the receptacle 220. When the free end 555 of the leaf spring 510 contacts the top of the receptacle 220, the spring 510 becomes a hard stop to prevent the culture bottle 230 from moving further into the receptacle 220. When the culture bottle 230 is released after insertion, the leaf spring 510 presses the culture bottle 230 against the tab 417 of the receptacle 220 extending from the outer surface of the drum 240. The culture bottle 230 is removed from the receptacle 220 by lifting the bottom 416 of the culture bottle 230 upward through the proximal end 420 of the receptacle 220, either manually or using a robot. FIG. 28A shows a drum 240 having the receptacles shown in FIGS. 20A - C. The receptacles 220 with leaf springs are provided as columns, and the drum 240 is formed by integrally attaching the columns. The resulting structure is a round drum 240 (FIG. and Figure 28B ) having a circular outer and inner perimeter for integrating the rows. 29 )

[0063] Figure 20D shows a part of the drum 240 having a plurality of vertical rows of the receptacle 220 shown in FIGS. 20A - C. The drum is shown in a cutaway view to show the support of the culture bottle 230 in the receptacle 220. The topmost receptacle 220 is empty. In the embodiment shown in FIG. 20D, a pivot arm 551 is provided for fixing the culture bottle 230 in the receptacle 220 instead of the leaf spring 550 already described. As the bottle 230 advances into the receptacle 230, the pivot arm 551 rotates clockwise to fix the culture bottle 230 in the receptacle. The resistance to the pivot arm 551 is applied by a coil spring 552 fixed by a pin 556 in the receptacle.

[0064] An alternative to the receptacle shown in FIG. 20D is shown in FIGS. 20E - H. Referring to FIG. 20E, the pivot arm 551 shown in FIG. 20D is replaced by a deformable material 553. In one example, the deformable material 553 is a peristaltic tubular material, although other conventional deformable materials are also contemplated. The key property of the deformable material is its elasticity assuming shape recovery after each deformation by the insertion of the culture bottle into the receptacle. The bottom part of the receptacle 220 is a light pipe 515.

[0065] The deformable material 553 is placed in the tapered portion 554 of the receptacle 220. Referring to FIG. 20F, an end view of the receptacle (220) shows the deformable material 553 (along the tapered portion 554 of the receptacle) at the top part of the receptacle. Suitable deformable materials include elastomeric materials and foamed materials in addition to the elastomeric peristaltic tubular material described above.

[0066] Figure 20G is a perspective view of a receptacle 220 with a portion of a second receptacle formed thereon. The culture bottle is held within the receptacle as described above. The tab 417 holds the culture bottle 230 firmly within the receptacle 220. Other materials having sufficient frictional properties when used in contact with the bottle 230 are also contemplated as deformable materials. Such friction prevents rotation of the bottle 230, and thus the measurement system can obtain a high-quality signal that rotates and vibrates and has less noise introduced by the rotating bottle.

[0067] Referring to FIG. 22, when the bottle is not fully inserted into the receptacle 220, the leaf spring 510 will hold the bottle in the overlay position 570. Then, when the bottle is not fully inserted into the receptacle 220, the culture bottle 230 will not appear to be properly seated within the receptacle 220. If the culture bottle 230 is present within the receptacle but not fully seated within the receptacle, the bottom 416 of the culture bottle will not allow rotation of the bottle drum 240 by the module. The module detects the unseated bottle 570 by detecting the jammed bottle drum 240 and sends a signal to the system. The user will be notified to clear the obstruction by removing or fully inserting the bottle 230.

[0068] The neck-in oriented culture bottle provides several improvements over the prior art neck-out orientation. The prior art drum held the culture bottle at an angle of 20° from horizontal upward during reading. By positioning the neck of the bottle inward, the rotation of the bottle drum pushes the culture medium / resin in the bottle toward the bottom of the bottle. Thus, in the case of a neck-in configuration, the culture bottle can be held in the drum in a horizontal position. While optically inspecting the bottle, the drum rotates at a rate that pushes the culture medium / resin in the culture bottle against the side of the culture bottle at a standard 20° angle. For a drum with the bottom of the bottle positioned at a diameter of 22 inches, the diameter of the drum is measured from the bottom of the bottle on one side of the drum to the bottom of the culture bottle on the opposite side of the drum. A drum rotation speed of about 37 RPM induces a 20° angle for the culture medium / resin toward the bottom of the bottle. For comparison, the rotor of the prior art device rotates at about 30 RPM for both reading and agitating the culture bottle. Optionally, the rotation speed of the drum can be selected to operate the drum like a centrifuge to drive additional separation of the solid portion (i.e., culture medium and resin) of the sample from the liquid portion of the sample.

[0069] Figure 26 shows a bottle stop 1000 that can be placed at the end of the bottle receptacle 220. The bottle stop 1000 is a simple keyhole slot 1010 with a top opening 1015 having a circumference sufficient for the crimp cap of the culture bottle to pass through. When the culture bottle seats in the receptacle 220, the neck of the culture bottle fits into the narrower opening 1020 of the keyhole slot 1010 that is not wide enough for the crimp cap of the culture bottle to pass through. Thus, the keyhole slot 1010 holds the culture bottle in a predetermined position in the bottle receptacle until the culture bottle is removed from the bottle receptacle either manually or by use of automation (e.g., a robot).

[0070] In the case of orientation using the neck-in of the culture bottle, it is necessary to arrange the measurement electronic circuits around the bottle drum. As illustrated herein, these electronic circuits are arranged in the front right corner. The bottom of the culture bottle is more spaced in the case of the neck-in configuration than in the case of the neck-out configuration. This reduces any possible crosstalk to the measurement system (e.g., crosstalk due to fluorescence emission from bottles adjacent to the bottle being measured is reduced or eliminated).

[0071] As described herein, the module rotates the drum for both the positioning of the bottle for user access and the positioning of the bottle for automatic access. The module also rotates the culture bottles to agitate them.

[0072] Optionally, the drum motion system has a direct drive electric motor attached to a shaft, with a drum bearing attached to this shaft and the drum rotating around the shaft. The direct drive electric motor does not require the additional parts that are necessary in the case of a belt drive electric motor or a rim drive electric motor. The direct drive electric motor is a more reliable solution and is quieter than other conventional electric motors.

[0073] The drum is accelerated to agitate the bottles in the drum where the bottles are held in neck-out, and centrifugal force is used to push the culture medium / resin into the necks of the bottles. The drum is then decelerated to allow the flow of the culture medium / resin back to the bottom of the culture bottle. Optionally, this motion profile is repeated approximately every 2 seconds, creating a motion of the culture medium / resin in the bottles similar to the motion of the culture medium / resin when the culture bottles are rocked in prior art devices.

[0074] The horizontal acceleration of the bottle that occurs during the angular acceleration stirring process described above does not occur in prior art devices, and the resulting stirring is advantageous. Optionally, the drum is operated to provide acceleration and deceleration at large drum angles with low frequency (low frequency). Such movement will move the liquid (i.e., culture medium / resin / sample) in the culture bottle from the base of the culture bottle to the neck of the culture bottle and from the neck of the culture bottle to the base of the culture bottle.

[0075] Optionally, the drum is operated to provide acceleration and deceleration at small drum angles with high frequency (high frequency). Such movement moves the liquid (i.e., culture medium / resin / sample) in the culture bottle from side to side within the bottle. This movement is similar to the movement imparted to the liquid in the culture bottle by prior art devices.

[0076] Optionally, deformations and combinations of the above movement profiles are contemplated, along with forward and backward movement of the drum, or movement in a single direction.

[0077] Optionally, the drum is operated to periodically impart sudden decelerations to move blood, resin, and bacteria that may be settled in the bottle. Some bacteria are damaged by such continuous intense stirring. Such movement occurs only rarely while the device is operating (e.g., once an hour or once at the end of an individual measurement cycle).

[0078] Other mechanisms for moving the drum are contemplated instead of the direct drive motor and bearings on a solid shaft described above. The purpose of such alternative mechanisms is to i) minimize the vertical spacing between the bottle drums, minimize the spacing between the drums to increase the bottle density in the cabinet, and iii) provide the user with a more uniform row of bottles during the manual workflow.

[0079] One example is a rotary rack that is attached to a gear adapter ring (GAR) rotating on a ring bearing and is driven by an electric motor and a toothed belt. The bottle drum in the module can likewise be attached to the GAR and driven by a toothed belt. The bottle drum will open at the top, and all connections to the electronic circuitry inside the drum will be routed above the drum.

[0080] Figure 23 shows such a drum 240 rotating on a large diameter ring bearing 600. The curvature of the drum 240 is evident from the changes in distance and angle of the bottle receptacle 220. The bottle 220 is necked in, which means that the measurement system (not shown) is located outside the drum assembly. The illustrated embodiment is adapted to a belt drive base by an electric motor outside the drum. Optionally, it is also possible to use a direct drive electric motor and a ring bearing disposed in the center of the base. The sensitivity of the bottle drum in the measurement system of the modules described herein to the speed of the bottle drum is not as sensitive as the sensitivity of the measurement system in prior art systems to the speed of the rotor.

[0081] Referring to Figure 24, the apparatus described herein optionally has an LED having either a first color (e.g., green) or a second color (e.g., blue) for source illumination. Additional LEDs acquire reference readings. As can be seen from Figure 24, the light indicating the reference reading activates when the indicator dye (bromocresol purple (BCP)) in the positive state (% transmittance) becomes equal to the BCP in the negative state. A positive indication (display) is obtained when the percent transmittance for the positive state exceeds the % transmittance for the negative state. The wavelength of the blue LED exists at a point on the response curve that is not affected by the pH state of the blood culture in the culture bottle. The ratio of the readings from bottles using blue excitation light to the readings obtained using green excitation light should be proportional to the slope of the BCP response curve that is proportional to the pH state of the BCP. The pH readings from the BACTEC bottles are an improved indicator of biological growth in the bottles.

[0082] The devices described in this specification provide the advantages of 1) noise reduction (i.e., the ratio of the growth signal to the reference signal is not affected by the position, temperature, and sensor variability of the bottle), 2) detection of growth in vials with a delayed introduction into the system (i.e., the dual measurements described above provide a reference so that it is not necessary to continuously sample the contents of the glass bottle to confirm positivity by detecting the growth acceleration while it is growing), and 3) a signal quality indicator (i.e., the reference signal is an independent indicator of the integrity of the station hardware).

[0083] Also described in this specification is a method for operating the devices described herein. According to this method, the movement of the bottle drum is controlled to support the user workflow. The user is requested to open the door of the module to access a bottle drum containing the blood culture bottles illustrated herein. The bottle drum drive motor stops the bottle drum at a specific position before the door is opened. As described above, only the sectors of the bottle drum are accessible when the door of the module is open and the user can access them. The user can instruct the control system as to which sector of the drum the user wishes to access.

[0084] When the door opens, the door interlock switch will reduce the maximum power delivered to the bottle drum motor. According to this method, the bottle drum motor drives the bottle drum at low power and low speed. The status of the bottles in the bottle drum is indicated using light near the individual culture bottle receptacles in the bottle drum. As described in this specification, the light source and sensor are located at fixed positions inside the bottle drum module. The light source illuminates the light pipe for that station when the station in the bottle drum is aligned with the light source.

[0085] The user accesses the bottle drum and inserts the culture bottle into an available station (also referred to herein as a bottle receptacle), or removes a negative or positive bottle from the station. The user removes the culture bottle having the target state (i.e., positive or negative). For example, the positive bottle is accessed by the user for further precision inspection, and the negative bottle is collected by the user for disposal. When the user's access to the accessible section of the drum is complete, the user can manually move the drum left and right, overcoming a small resistance to the rotation applied by the electric motor. The change in the position of the drum is detected by the control system, and in effect, the force applied by the electric motor is removed, and thus the drum can be rotated relatively freely. When the control system releases the drum from the electric motor resistance to manual rotation, the control computer determines the next position of the bottle drum that will allow the user access to the culture bottle of interest. When access by the user to the culture bottle of interest becomes possible, the control system sends a signal to the bottle drum motor to stop the bottle drum at that position.

[0086] When the bottle drum rotates, the bottle state indicator light source is illuminated so that the state of the culture bottle is correctly indicated (displayed) via the light pipe aligned with the bottle receptacle / station. The bottle drum control system includes an encoder that communicates with the bottle drum control system so that the control system is always aware of the position of the bottle drum (and thus also the position of the individual receptacles / stations at all times). The control system illuminates the individual stations / receptacles when the bottle drum advances the bottle receptacle / station from one position to the next.

[0087] In the case of the method described above, it may not be desirable for the user to manually advance the drum or the rotating rack. In this specification, a system is contemplated that has control to allow the user to advance the rotation of the drum to present additional bottles. Such control may simply be a button or icon on the touch panel that allows the user to advance the drum clockwise or counterclockwise. If the system described in this specification has such control, the user is prevented from reversing those controls and manually moving the drum. Using such control, the drum or the rotating rack can be advanced incrementally (i.e., intermittent drive), or can be advanced continuously (by continuous drive).

[0088] In this specification, the term "comprising" should be understood in its "broad" sense, i.e., the sense of "including", and thus is not limited to its "narrow" sense, i.e., the sense of "consisting only of". The corresponding meaning, when it appears, shall be attributed to the corresponding terms "comprises", "comprised of".

[0089] Although specific embodiments of the present technology have been described above, it will be apparent to those skilled in the art that the present technology can be embodied in other specific forms without departing from the essential characteristics of the present technology. Therefore, these embodiments and examples are illustrative and not restrictive in any way.

[0090] Furthermore, it should be understood that any reference in this specification to a subject matter known in the art does not constitute an admission that such subject matter is widely known to those skilled in the art relevant to the present technology, unless otherwise indicated.

Claims

1. 1. An apparatus for storing and monitoring blood culture bottles, comprising: a drum having an outer perimeter and an inner perimeter, the outer perimeter having a diameter greater than a diameter of the inner perimeter, the drum having a plurality of receptacles, the 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 having a bottom portion and a neck portion, the blood culture bottle being received in the receptacle either with the bottom portion received at the distal end of the receptacle or with the neck portion received at the distal end of the receptacle; the drum periphery is disposed about an axis of rotation of the drum, the axis of rotation being perpendicular to a surface supporting the drum; the plurality of receptacles are arranged on the drum as an array of receptacles, the array having receptacles arranged both vertically and horizontally; Drums and a plurality of sensors and detectors aligned with each of a plurality of receptacles for testing the blood culture bottles for a change in a microbial growth indicator to determine whether the blood culture bottles are positive or negative for microbial growth; Including, the drum defines an interior space within the interior perimeter, and at least a portion of drum electronics is disposed within the interior perimeter of the drum in communication with the sensors and detectors for testing the blood culture bottles for changes in microbial growth indicators. Device.

2. The apparatus of claim 1 , wherein a plurality of drums are disposed within the housing.

3. 3. The apparatus of claim 2, wherein the housing has a door for accessing individual drums disposed within the housing.

4. The device of claim 2 or 3, wherein the housing has a touch screen.

5. 3. The device of claim 2, wherein the housing further comprises a rack for receiving blood culture bottles that are placed into or removed from the device.

6. 4. The apparatus of claim 3, wherein the drum has a plurality of panels defining vertical drum sectors.

7. 7. The apparatus of claim 6, wherein each vertical drum sector has a substantially equal horizontal span, each such that the horizontal span of a sector is substantially the same as the horizontal span of the housing door.

8. The apparatus of claim 2 , further comprising a drive motor for rotating the drum disposed within the housing.

9. The apparatus of claim 1 , wherein measurement electronics are disposed within the space defined by the interior periphery of the drum.

10. The device described in claim 1, wherein a blood culture bottle indicator electronic circuit is disposed within the space defined by the interior periphery of the drum.

11. The apparatus of claim 2 further comprising a heater disposed within said housing outside said exterior perimeter of said drum.

12. The apparatus of claim 2 further comprising a blower disposed within said housing outside said exterior periphery of said drum.

13. 9. The apparatus of claim 8, further comprising a shaft defining an axis of rotation, at least one bearing disposed coaxially with said shaft and said drum, thereby permitting rotation of said drum about said axis.

14. The apparatus of claim 13 , wherein the bearing is a ring bearing.

15. 2. The apparatus of claim 1, wherein the drum is assembled in layers, each layer being at least a portion of an entire row of receptacles, each layer having the inner perimeter and the outer perimeter.

16. The apparatus of claim 1 , wherein the drum is assembled in row segments, each row segment defining only a portion of the inner perimeter and the outer perimeter of the drum.

17. The device of claim 1 , wherein each of the plurality of receptacles has a respective elastomeric insert for receiving a blood culture bottle.

18. 2. The device of claim 1, wherein each of the plurality of receptacles receives the neck portion of the blood culture bottle at the distal end, and each receptacle includes a bottle stop and a canted coil spring spaced from the bottle stop, and wherein when the neck portion of the blood culture bottle is inserted into the receptacle, the canted coil spring is biased such that a cap disposed on the neck portion of the blood culture bottle advances past the canted coil spring and rests against the bottle stop, thereby allowing the canted coil spring to release tension and secure the blood culture bottle in the receptacle.

19. (0019, 0048, Fig. 17G) 2. The device of claim 1, wherein the plurality of receptacles each receive the neck portion of the blood culture bottle at the distal end, each receptacle including a bottle stop and an O-ring spaced from the bottle stop, the O-ring being sufficiently resilient to allow a cap disposed on the neck portion of the blood culture bottle to advance past the O-ring and rest against the bottle stop, which then releases tension to secure the blood culture bottle to the receptacle.

20. 2. The device of claim 1, wherein each of the plurality of receptacles receives the neck portion of the blood culture bottle at the distal end, and each receptacle includes a bottle stop and a ball plunger spaced from the bottle stop, and when the blood culture bottle is inserted into the receptacle, the ball plunger is biased such that a cap disposed on the neck portion of the blood culture bottle advances past the ball plunger and rests against the bottle stop, thereby allowing the ball plunger to release tension and secure the blood culture bottle in the receptacle.

21. 2. The device of claim 1, wherein each of the plurality of receptacles receives the neck portion of the blood culture bottle at the distal end, and each receptacle includes a bottle stop and a split retaining portion spaced from the bottle stop, the split retaining portion being biased to allow a cap placed on the neck portion of the blood culture bottle to advance past the split retaining portion and rest against the bottle stop, whereby the split retaining portion releases tension to secure the blood culture bottle to the receptacle.

22. 22. The apparatus of claim 21, wherein the split retaining portions are urged together by a canted coil spring.

23. 22. The device of claim 21, wherein the divided support portions are resilient segments.

24. 2. The device of claim 1, wherein each of the plurality of receptacles receives the neck portion at the distal end, and each receptacle includes a bottle stop and a plurality of resilient wings extending from the bottle stop, and when the blood culture bottle is inserted into the receptacle, the resilient wings are biased such that a cap disposed on the neck portion of the blood culture bottle advances past a flange portion of the resilient wings and rests against the bottle stop, thereby releasing tension on the resilient wings and allowing the flange portion to secure the blood culture bottle to the receptacle.

25. 25. The device of claim 24, wherein each of the plurality of receptacles further comprises a ball plunger, and wherein the bottle stop comprises a notch, and wherein as the blood culture bottle advances into the bottle stop, the bottle stop advances further into the receptacle until the ball plunger aligns with the notch, thereby securing the bottle stop to the receptacle.

26. 25. The device of claim 24, wherein each of the plurality of receptacles further comprises a notch, and wherein the bottle stop comprises a ball plunger, and wherein as the blood culture bottle advances into the bottle stop, the bottle stop advances further into the receptacle until the ball plunger aligns with the notch, thereby securing the bottle stop to the receptacle.

27. 2. The device of claim 1, wherein each of the plurality of receptacles further includes a tray portion on which the blood culture bottle is placed, the tray portion including a tab for securing the bottom portion of the blood culture bottle within the tray, and the receptacle further includes a stop portion, the stop portion positions the blood culture bottle in a predetermined fixed position within the receptacle.

28. 28. The apparatus of claim 27, wherein the stop portion comprises a leaf spring.

29. 30. The apparatus of claim 27, wherein the stop portion comprises a deformable material.

30. 30. The device of claim 29, wherein the stop portion further comprises a pivot arm that pivots in response to advancement of the blood culture bottle into the receptacle to secure the blood culture bottle in the receptacle.

31. 28. The apparatus of claim 27, wherein the stop portion comprises a resilient material selected from one of an elastomeric flexible tubular material, an elastomeric material, or a foam material.

32. 28. The apparatus of claim 27, wherein the tray portion further includes a light pipe that transmits a light signal from an indicator LED disposed within the interior periphery of the drum to a photodetector disposed on the exterior of the drum.

33. 28. The device of claim 27, wherein the bottle stop includes a keyhole element.

34. The apparatus of claim 1 , wherein the outer perimeter of the drum and the inner perimeter of the drum are circular.

35. The apparatus of claim 1 , wherein the exterior periphery of the drum and the interior of the drum are faceted.

36. 1. A method for controlling an incubator for a plurality of blood culture bottles, comprising: inputting a predetermined sector of a blood culture drum via a control interface, the blood culture drum including a rack that rotates about a vertical axis and defines a substantially circular inner perimeter and a substantially circular outer perimeter, the blood culture drum being a rotating drum; opening a door of a housing for the blood culture drum; substantially stopping the drum by reducing power to an electric motor used to rotate the drum so that the selected sector can be accessed through the open door of the housing; Including, the blood culture drum includes a plurality of receptacles, each of the plurality of receptacles adapted to receive and hold a blood culture bottle, each of the plurality of receptacles having an indicator at a proximal end thereof, the indicator providing an indication of whether a blood culture bottle in the receptacle is positive or negative for microbial growth; and at least one of the steps of: inserting a blood culture bottle into an empty one of the plurality of receptacles; removing a blood culture bottle from one of the plurality of receptacles; or removing a blood culture bottle from one of the plurality of receptacles and inserting a different blood culture bottle in its place; The blood culture bottle is removed based on its indicated condition. method.

37. 37. The method of claim 36, wherein each of the plurality of receptacles further includes a light pipe extending from the proximal end of the receptacle to a distal end of the receptacle.

38. 37. The method of claim 36, wherein the control interface is in communication with an encoder such that the control interface tracks placement of individual blood culture bottles within the rack.

39. 38. The method of claim 37, wherein the incubator further comprises a reading station, the reading station determining a status of the blood culture bottle as the bottle drum rotates the receptacle carrying the blood culture bottle past the reading station.

40. 40. The method of claim 39, wherein the incubator further comprises an indicator LED disposed at the distal end of at least a portion of the receptacle within the bottle drum.

41. 37. The method of claim 36, wherein the blood culture bottle is received in each of the plurality of receptacles neck-in.

42. 37. The method of claim 36, wherein the blood culture bottles are received bottom-in into each of the plurality of receptacles.

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