Disposable device for venting and dispensing aliquots from sealed containers

Abstract

A multi-port disposable device both vents a sealed culture vessel and aspirates a sample from the sealed culture vessel into a collection container. The multi-port disposable device has a first port configured to receive and attach to the top of the culture vessel. The multi-port disposable device has a second port configured to receive a sample collection container. The multi-port disposable device has a first needle and a second needle. The first needle has a cannula configured to pierce a septum or cap of the culture vessel. Optionally, the cannula terminates in a foam layer carrying a microbial agent, such that when the sealed culture vessel is vented, vapor transferred from the culture vessel to the cannula is absorbed by the foam. Optionally, the ports of the disposable device are configured like sleeves. The sleeve of the first port receives a portion of the culture vessel, and the second port receives a collection container. The second needle includes a cannula that pierces both the septum or cap of the culture vessel and the septum or cap of the collection vessel when the culture vessel and collection vessel are introduced into the instrument, thereby providing fluid communication between the culture vessel and the collection vessel. The second cannula provides a flow path for delivering the sample from the culture vessel to the collection vessel.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of the filing date of U.S. Provisional Patent Application No. 62 / 883,427, filed August 6, 2019, and the filing date of U.S. Provisional Patent Application No. 62 / 907,060, filed September 27, 2019, the disclosures of which are incorporated herein by reference.

[0002] The invention described herein relates to a two-port disposable device having a vent needle and a separate fluid transfer needle for both venting a culture vessel and obtaining an aliquot of sample from the culture vessel. [Background technology]

[0003] Various embodiments of the present disclosure describe systems and methods for testing samples (e.g., biological samples, environmental samples, food samples, etc.) for microbial contamination. A sample inoculated into a culture vessel undergoes changes in the state of the culture vessel over time if the sample is contaminated with microorganisms. If microorganisms are present in the sample, their metabolic activity alters the gas composition, gas pressure, and / or pH within the culture vessel. Because the internal gas pressure within the culture vessel increases over time (if microorganisms are present in the sample), the contents of the culture vessel cannot be touched without venting the gas from the culture vessel before removing it from the culture vessel. Therefore, there is a need for an instrument that allows for both venting the culture vessel and dispensing a sample from the culture vessel safely.

[0004] The detection of a positive blood culture (PBC) is just the beginning of a long series of processes to determine the identity of the microorganism in the culture vessel and to determine the appropriate drug treatment for the patient infected with that microorganism. The first step is to remove the microorganism from the bottle and place it in an appropriate collection vessel for downstream processing by instrumentation for identification and antibody sensitivity.

[0005] BD BACTECTM In blood culture containers, such as vials (BACTEC is a trademark of Becton Dickinson), bacterial growth generates carbon dioxide (and other gases, such as CO2, depending on the type of microorganism in the sample). In either case, the production of these gases by the microorganisms causes a slight increase in the internal pressure of the culture container. The vial septum must be pierced to eliminate or contain the aerosolized bacterial medium. This prevents contamination of internal equipment surfaces and potential cross-contamination of samples. Access to the contents of the blood culture vial without leaking them into the surrounding environment is of paramount importance. Solutions to this problem are continually being sought. Summary of the Invention

[0006] In a microbiology laboratory environment, blood culture bottles inoculated with samples undergo an incubation process to detect bacterial growth. For positive blood cultures, aliquots are taken from the bottles for downstream identification and susceptibility testing. The disposable device described herein is used in the preparative stage of blood culture processing. The disposable device has a housing with at least two needles of different lengths disposed therein. The disposable device has two opposing receiving portions (also referred to herein as ports or sleeves). One receiving portion is configured to be attached to a blood culture container, such as a blood culture bottle. First, the longer needle of the disposable device pierces the septum of the culture bottle. If pressurized gas is present, it escapes through the vent needle, and the aerosol is trapped in a thick layer of open-cell foam containing an antibacterial agent. During venting, the disposable device and blood culture container assembly are positioned in a generally upright position so that the gas escapes upward.

[0007] Optionally, after venting, the two-port disposable and blood culture container assembly is inverted at least somewhat so that the disposable is held below the blood culture bottle and the liquid contents of the blood culture are in fluid communication with the needle of the disposable. Optionally, after venting, the blood culture container remains in an upright position for dispensing. A sealed, sterile collection container is inserted into the second sleeve of the second port of the two-port disposable such that the seal of the collection container is pierced by the second needle. A vacuum on the collection container draws an aliquot of the blood culture from the culture container and into the sterile collection container.

[0008] For example, some embodiments describe a two-port disposable instrument equipped with a means for piercing the septum or cap of a culture vessel and allowing the culture vessel to be vented prior to withdrawing a sample. This allows pressure inside the culture vessel to be released prior to withdrawing an aliquot of the culture vessel contents. In some embodiments, gas in the headspace of the culture vessel can be vented from the two-port disposable instrument without contaminating the environment outside the assembly and without resulting in sample contamination.

[0009] In some embodiments, the two-port disposable device includes a membrane that prevents liquid carried by the released vapor from leaking out of the two-port disposable device, and the two-port disposable device is used to withdraw an aliquot of sample from a culture vessel (typically combined with a culture medium) into a collection vessel for subculture or aliquoting for another diagnostic process, such as molecular diagnostics.

[0010] One example of a two-port disposable device described herein has a first port configured to receive and attach to the top of a culture vessel. The two-port disposable device has a second port configured to receive a sample collection container. The two-port disposable device has a cannula configured to penetrate a septum or cap of the culture vessel. The cannula terminates in a layer of antimicrobial foam so that vapors transferred from the culture vessel through the cannula are absorbed and neutralized by the foam. Optionally, the ports of the disposable device are configured like sleeves. The sleeve of the first port receives a portion of the culture vessel, and the sleeve of the second port receives the collection container. The second cannula penetrates both the septum or cap of the culture vessel and the septum or cap of the collection container, providing fluid communication between the culture vessel and the collection container. The second cannula provides a flow path for transferring a sample from the culture vessel to the collection container. The first cannula provides a flow path for air to enter the culture vessel as the sample is transferred to the collection container.

[0011] Optionally, the collection container is a syringe. In this embodiment, the second cannula terminates in the syringe. The syringe withdraws a sample from the culture vessel for delivery to the collection container. Optionally, the second cannula terminates in a connector, such as a Luer lock connector, that connects the syringe to a disposable device, thereby providing a vacuum source sufficient to withdraw a desired aliquot from the culture vessel. Such a connector also allows the syringe to be separated from the device. [Brief explanation of the drawings]

[0012] [Figure 1] A cutaway view of a disposable device. [Rubber sleeve?] [Figure 2] FIG. 2 is a cutaway view of the disposable device of FIG. 1 assembled to a blood culture container. [Figure 3] 3 illustrates the orientation of the assembly of FIG. 2 during venting and dispensing. [Figure 4]2 illustrates the position of the disposable of FIG. 1 relative to the blood culture bottle to which it is assembled during venting. [Figure 5] 2 is a portion of the disposable device of FIG. 1 illustrating two needles and antimicrobial foam. [Figure 6] FIG. 10 is a cutaway side view of two needles passing through a retaining insert. [Figure 7] FIG. 10 is a perspective view of two needles passing through a retaining insert. [Figure 8] 1 illustrates the housing of a disposable device. [Figure 9] 1 illustrates one embodiment of a vent needle. [Figures 10A-10B] The reaction of the contents of a blood culture bottle at a 45-degree angle upward and a 20-degree angle downward (both relative to the horizontal) is illustrated. [Figures 11A-11C] The response of the contents of blood culture bottles at inclination angles of 9.5 degrees, 12.5 degrees, and 20 degrees to the horizontal is illustrated. [Figure 12] An inverted blood culture bottle is shown, showing the relative volumes of medium and solution as well as the relative volumes of headspace. [Figures 13A-13D] 1 illustrates different vent needle configurations. [Figure 14] FIG. 11 is a detailed view of one vent needle configuration. [Figure 15] FIG. 10 is a detailed cross-sectional view of a second port of the disposable device connecting with a collection container. [Figure 16] FIG. 16 is a cross-sectional view of FIG. 15 showing the placement of the dispensing needle from the side of the disposable device. [Figure 17] FIG. 10 is a cross-sectional view of the first port of the disposable device, showing placement of the dispensing needle from the side of the disposable device. [Figure 18] FIG. 10 is a cross-sectional view of another embodiment of the disposable device, in which the culture bottles are dispensed in an upright position. [Figure 19] FIG. 19 is a cross-sectional view of the disposable device of FIG. 18 in an upright position and positioned for dispensing. [Figure 20] FIG. 20 is a cross-sectional view of the disposable of FIG. 19, with the collection container in fluid communication with the culture bottle through the disposable. [Figure 21] FIG. 1 is a cross-sectional view of a three-port configuration of a disposable device described herein attached to a culture bottle for aeration. [Figure 22] FIG. 24 is a cross-sectional view of the device of FIG. 23 rotated to a dispensing position. [Figure 23] FIG. 25 is a cross-sectional view of the device of FIG. 24 with a collection container disposed therein. [Figure 24] FIG. 1 is a perspective view of a three-port configuration of a disposable device with features for automated operation. [Figure 25] FIG. 10 is a cutaway view of a two-port device with only one needle. [Figure 26] FIG. 10 is a diagram of a two-port device with a syringe collection device. [Figure 27A] 27 illustrates the embodiment of FIG. 26 with a luer connector for a syringe. [Figure 27B] 27 illustrates the embodiment of FIG. 26 with a luer connector for a syringe. [Figure 27C] 27 illustrates the embodiment of FIG. 26 with a luer connector for a syringe. DETAILED DESCRIPTION OF THE INVENTION

[0013] FIG. 1 is a cutaway view of a two-port disposable device according to one embodiment of the present invention. The disposable device 100 has a housing 110 comprising a first port 120 and a second port 130. Optionally, the housing 110 is a single piece. The first port 120 and the second port 130 are configured like a sleeve. The two-port disposable device 100 has a first needle 140, which is a vent needle, and a second needle 150, which is a dispensing needle. Both needles are retained within the housing 110 by a needle-retaining insert 160 that separates the first port 120 from the second port 130 (through which the needles are inserted). The needle-retaining insert is secured by flanges 161 formed at each distal end of the first port 120 and the second port. The flanges 161 also prevent containers entering the first and second ports from overshooting into adjacent ports. Optionally, the two-port disposable device 100 also has a disposable antimicrobial foam 170 located at the distal end of the second port 130 and adjacent to the needle insert 160. Both needles pass through the needle insert 160. The vent needle 140 terminates in the antimicrobial disposable foam 170. The dispensing needle passes through the antimicrobial foam layer 170.

[0014] Optionally, the two-port disposable instrument has exterior features on the molded housing 110 that facilitate automated gripping and manipulation of the two-port disposable instrument. Examples of such features are illustrated in Figure 1. Shown in the figure are a gripper center rib 180, a stop ring 190, and a key 195.

[0015] Referring to Figure 2, the assembly of the two-port disposable device 100 described in Figure 1 is shown assembled to a culture bottle 200 and a collection tube 210. The vent needle 140 is positioned in the two-port disposable device 110 so that it pierces only the cap 220 of the culture bottle 200 and not the septum 230 of the collection tube 210. The dispensing needle 150 pierces both the cap 220 of the culture bottle 200 and the septum 230 of the collection tube 210. The culture bottle 200 is received within a sleeve in the first port 120, and the collection tube 210 is received in the second port 130. The first port 120 and the second port 130 are sleeve-like formed within the integrated housing 110 of the two-port disposable device 100. As described in Figure 1, the vent needle 140 and the dispensing needle 150 are retained within the two-port disposable device by a needle insert 160. An antimicrobial disposable foam 170 is disposed at the distal end of the second port 130 adjacent the retaining insert. Optionally, an antimicrobial foam can be disposed at the distal end of the first port 120.

[0016] Two-port disposable devices address the problem of aerosolization. As previously explained, bacterial growth in blood culture bottles generates gases such as carbon dioxide or oxygen (depending on the type of bacteria), creating a small amount of pressure within the bottle. To prevent contamination of internal device surfaces, the septum of the culture bottle must be pierced to eliminate or contain the aerosolized bacteria and medium. Two-port disposable devices address this problem by inserting an antibacterial-infused disposable foam into the venting side of the vent needle, so that aerosolized bacteria and medium are trapped within the foam and do not enter the ambient environment of the two-port disposable device.

[0017] Two-port disposable devices address the issue of contamination. As mentioned above, there is a risk of microbial contamination when aerosols carry bacteria from the vent into the surrounding environment. The aerosol collection foam minimizes or even eliminates microbial contamination on the surfaces of the culture vessel and collection vessel. The aerosol collection foam also reduces or eliminates contaminants from entering the culture vessel during aeration. This allows for the removal of sample from the culture vessel that remains in the culture bottle even after the initial sample has been taken.

[0018] The two-port disposable device facilitates automation by including features such as the above-described gripper center rib 180, anti-rotation ring 190, and key 195. These features facilitate the use of automated equipment to reliably remove the two-port disposable device from its packaging, grip and manipulate the two-port disposable device for venting and dispensing from culture vessels, and discard the two-port disposable device.

[0019] Two-port disposable devices are equipped with needles that do not "pierce" the septum / stopper of the culture / collection vessel. A hole occurs when the piercing device leaves a permanent path through the septum / stopper. Piercing the septum / stopper in a way that leaves a tear or other damage to the septum or stopper can result in leakage and must be avoided.

[0020] Media often contain particles in addition to nutrients. TM The Plus medium contains beaded resin for antibody neutralization. The needle for the two-port disposable device has a cannula with a diameter that prevents the beaded resin from being aspirated into the collection container along with the sample.

[0021] Even in automated systems, needle safety is an issue. As an option, two-port disposable devices minimize the operator's exposure to exposed tips.

[0022] To ensure that a sufficient aliquot of sample is aspirated into the collection container, the two-port disposable apparatus 100 is assembled to the culture vessel 200 and collection container in the manner illustrated in FIG. 3. In step 1, the two-port disposable apparatus 100 is assembled to the culture vessel 200. The vent needle 140 is inserted through the culture bottle cap 220. After venting, in step 2, the two-port disposable apparatus 100 is advanced further toward the culture vessel 200 so that the sorting needle 150 pierces the culture bottle cap 220. In step 3, the assembly of the two-port disposable apparatus 100 and the culture vessel 200 is rotated / rocked to allow beads in the medium / sample to settle to the bottom of the culture bottle 200. The assembly of the two-port disposable apparatus 100 and the culture vessel 200 is then placed at a negative angle relative to the horizontal, as illustrated in step 4. In step 5, the collection container 210 is inserted into the second port 130 of the two-port disposable apparatus 110 so that the sorting needle 150 pierces the septum 230 of the collection container 210. The assembly of the collection container 210, two-port disposable apparatus 100, and culture vessel 200 is maintained at a negative angle during sample collection, after which the collection container 210 is removed from the assembly in step 6. In step 7, the culture vessel 200 is removed from the two-port disposable apparatus, and the two-port disposable apparatus is discarded.

[0023] 4 illustrates the two-port disposable instrument being advanced to contact the culture vessel 200 to perform the first venting step and position it for the second dispensing step. During the first venting step, only the first venting needle 140 pierces the cap 220 of the culture vessel 200. The distal end of the venting needle 140 is embedded in a disposable antimicrobial foam 170 so that aerosols released as a result of venting the culture vessel 200 are captured in the antibacterial foam, thereby reducing or eliminating the risk of contamination due to the venting. Because the venting needle extends deeper into the first port 120 than the dispensing needle, the culture vessel 200 is vented when the two-port disposable instrument is further advanced and first contacts the culture vessel. The dispensing needle 150 does not pierce the culture vessel cap 220 until the collection vessel 210 is inserted into the second port 130, which causes the dispensing needle to pierce the culture vessel cap 220.

[0024] In an automated method, a robotic gripper (not shown) acquires the two-port disposable instrument 100 and positions the first port 120 concentrically above an upright culture vessel 200. The two-port disposable instrument 100 translates along the Z axis so that the vent needle 140 contacts and pierces the cap of the culture vessel. Upon piercing the cap 220 by the vent needle 140, pressurized gas, if present, escapes through the vent needle 140, and the aerosol is captured in a layer of appropriate thickness of open-cell foam (i.e., disposable antimicrobial foam 170), preferably containing an antibacterial agent.

[0025] FIG. 5 is a detailed view of a portion of the two-port disposable instrument 100 in which a disposable antimicrobial foam 170 is located at the distal end of the second port 130. A needle insert 160 is located at the distal end of the first port 120. A layer of foam saturated with an antibacterial agent presses against the closure at the top of the collection vessel (e.g., a Becton Dickinson BD septum cap or vacutainer reseal). The automated instrument can rotate the housing 110 so that the disposable antimicrobial foam layer 170 sweeps radially across the top surface of the needle insert 160 before the needles 140 and 150 are removed from the culture vessel and collection vessel, respectively. FIG. 5 also illustrates that the interior of the housing 110 has a flange 240 that extends through the reduced diameter portion 250 of the needle insert 160. The large diameter portion 260 of the needle insert 160 sits on the flange 240 to secure the needle insert to the housing 100 and provide a seal between the first port 120 and the second port 130 .

[0026] FIG. 6 is a detailed cutaway view of the needle insert 160. FIG. 6 illustrates the large diameter portion 260 of the needle insert 160, which rests on the flange 240 (FIG. 5) to secure the needle insert 160 to the housing 110 and thereby provide a seal between the first port 120 and the second port 130. The dispensing needle 150 has a sheath 151 thereon. The sheath seals the dispensing needle when the disposable is secured to the culture vessel. The sheath prevents the contents of the culture vessel from spilling out of the culture vessel before the collection vessel is attached to the disposable. One example of a suitable material for the needle insert 160 is butyl rubber. An optional sheath placed over one or more needles to prevent contamination can also be made of butyl rubber. Alternatively, a foam cylinder may be used to pierce the septum and compress the needle before the Bactec TM A thick foam layer can be implemented to cover the needle which performs a purging action against the top of the bottle. Figure 7 illustrates the needle insert of Figure 6 in perspective view.

[0027] FIG. 8 is a diagram of the housing 110. As shown, the housing has a first flange 265 at the proximal end of the first port 120 and a second flange 190 (i.e., a rotation stop ring) at the proximal end of the second port 130. The flange 265 has a symmetrical shape, while the second flange 190 has an asymmetrical shape. The asymmetrical flange 190 has two portions adjacent to opposite sides of the proximal end of the second port 130. The asymmetrical flange 190 can be received and locked into an automated instrument that positions the instrument 100 in a blood culture container. The gripper center rib 180 allows the jaws of the gripping mechanism to grip the two-port disposable instrument in a coaxial position for each sample aliquot obtained using the instrument.

[0028] The outer diameter key feature 195, in combination with the gripper geometry, acts to lift the two-port disposable device 100 in the same radial direction, which predicts that the vent needle will be inserted into the vial at the same radial angle for each sample.

[0029] As mentioned above, optionally, the needle does not perforate the septum through which it penetrates. Those skilled in the art will be aware of measures in both needle and septum design that reduce the likelihood of the septum being perforated. One example of a needle 300 designed to manage or reduce the likelihood of perforation is shown in FIG. 9. Needle 300 has a first bevel 310, a second bevel 320, and a heel feature 330. To reduce perforation, heel feature 330 is bead blasted to blunt its edge to encourage displacement of the septum material without cutting it.

[0030] The cap 220 is fabricated from a conventional septum material, such as brominated butyl rubber or chlorinated butyl rubber. Typically, such materials have a durometer Shore A hardness of about 40 to about 50. Such materials can also be used for the stopper 230 for the collection tube 210. Materials with lower durometer values ​​are less likely to be punctured. Lubricants such as silicone and Teflon are optionally used on the outer surface of the needle to reduce penetration force, facilitate insertion, and reduce the likelihood of perforation and tearing. Polishing the heel of the bevel to address these issues is also considered to prevent the needle from puncturing the septum.

[0031] One potential problem with aspirating samples from culture vessels is that the resin in the culture medium can clog the needle. Solutions to this problem include providing the needle with a large diameter cannula and making the needle opening either large enough to prevent the resin from entering the cannula, or small enough so that the resin cannot enter the cannula.

[0032] 10A and 10B illustrate the process of generating a relatively bead-free suspension 350 with the bottle 110 initially angled 45 degrees upward (FIG. 10A). The bottle is then rotated to a downward angle of approximately 20 degrees. The relatively sediment-free portion of the sample 350 flows into the neck 360 of the bottle 110. This allows the needle 150 to be shortened, so that the shorter needle does not aspirate the lower portion of the suspension containing the resin / media 370 sediment. When the bottle is oriented as shown in FIG. 10B, the second bevel 320 faces upward to provide more control over the aspiration of the suspended resin beads. To withdraw (i.e., aspirate) a sample from a culture bottle, the angle of the bottle neck 360 relative to the horizontal should be between approximately 9.5 degrees and approximately 20 degrees. Such orientations of the culture bottle 200 are illustrated in Figure 11A (9.5 degrees), Figure 11B (12.5 degrees), and Figure 11C (20 degrees).

[0033] Figure 12 shows an inverted (180 degree rotated) view of the culture bottle 200. Approximately 30 seconds must be allowed for the resin / medium 370 to settle within the neck 360 of the culture bottle 200 (i.e., for the resin to fill the neck to a depth of approximately 57 mm). At that point, the sorting needle (150 in Figure 10B) can be inserted approximately 65 mm into the culture bottle to bypass the resin / medium 370 and collect a sample from a relatively sediment-free portion of the sample 350. In this embodiment, a sorting needle approximately 100 mm in length is required to reach the relatively sediment-free portion of the sample 350.

[0034] Figures 13A-13D illustrate different optional needle types that can be used as the dispensing needle 150 described herein. Figures 13A-13B illustrate a side view (Figure 13A) and a top view (Figure 13B) of a Slotte needle 400 having a needle opening 410. Figures 13C-13D illustrate a side view (Figure 13C) and a top view (Figure 13D) of a Whittaker needle 420 having a needle opening 430.

[0035] FIG. 14 illustrates another optional needle design with multiple openings 440 on the side of the needle / cannula. Optionally, the needle is a side pencil-tip needle. The size of the openings 440 can optionally be controlled to be smaller than the resin beads in the medium. The number of openings 440 can also be controlled. Typically, such needles have a closed pencil-tip 450 and typically a single side hole 440 for aspirating fluid into a collection container (not shown). Examples of other needle point styles include Pencan® (a registered trademark of B. Braun Medical Inc.) and Gertie Marx needles. These needle designs are well known to those skilled in the art and will not be described in detail herein. These needle types are typically used for spinal applications and can be manufactured down to a size of 25 gauge (0.515 mm). Optionally, the needles described herein are approximately 20 gauge. Optionally, the needles illustrated in FIGS. 13A-13D can have multiple openings.

[0036] For the embodiment shown in Figure 14, the single pencil point design has an aperture 440 that is approximately 0.15 mm in size. Because the bead diameter size is approximately 0.2 to approximately 0.6 mm, resin from the sample / media will not enter the aperture 440 of the single pencil point design. The needle geometries described herein are considered suitable for piercing the septums of the culture bottle 200 and collection container 220.

[0037] Needles 140 and 150 are held within housing 110, thereby protecting the user of the device from accidentally coming into contact with the sharp tips of needles 140 and 150. Optionally, needles 140, 150 are further covered with butyl rubber sleeves to further protect the user from accidental sticks.

[0038] Optionally, the disposable devices described herein are used in an automated process. In such a process, the procedure of which is illustrated in Figure 3, venting with needle 140 occurs before first port 120 is fully advanced toward neck 360 of culture bottle 200. After needle 140 vents culture bottle 200, culture bottle 200 is slowly rotated and inverted. After bottle 200 is tilted to approximately 45 degrees, rotation is stopped for approximately 30 seconds to allow resin beads / media 370 to settle to the corners of culture bottle 200.

[0039] Rotation is then resumed to the predetermined dispensing angle. In this example, the dispensing angle is approximately 20 degrees. The disposable device is then advanced further toward the neck 360 of the culture bottle 200 so that the dispensing needle 150 pierces the cap 220 (i.e., septum) of the culture bottle 200. During this second piercing, fluid flows from the culture bottle 200 into the collection tube 210. After collection, the collection tube 210 is detached from the disposable device 100. The culture bottle 200 is then removed from the disposable device. The user then disposes of the disposable device, along with the tip embedded in the disposable device, according to medical waste disposal procedures.

[0040] Figure 15 is a detailed cross-sectional view of the second port 130 of the disposable device 100. The vent needle 140 terminates in a needle insert 160 that connects to a collection container (not shown). An antimicrobial foam layer 170 is positioned adjacent to the needle insert 160 at the distal end of the port 130. A dispensing needle 150 is in fluid communication with both the illustrated second port and the first port 120 (Figure 17).

[0041] Figure 16 is a cross-sectional view of Figure 15 illustrating placement of the dispensing needle 150 from the side of the second port 130 in the disposable device. The dispensing needle 150 is shown as having a bevel as described above, which reduces the risk of handling the tip.

[0042] FIG. 17 is a cross-sectional view of the first port 120 of the disposable device, showing the placement of the vent needle 140 from the side of the first port 120 of the disposable device. The needle is held in the device by a needle insert 160. As mentioned above, disposable foam is provided to absorb aerosols vented from the culture bottle during venting. The difference in length of the two needles (140, 150) extending into the first port 120 and the speed at which the two-port disposable device advances and contacts the culture vessel 200 determine the length of time the culture vessel 200 is vented. Additionally, the difference in length between the vent needle and the dispensing needle is sufficient to allow an automated instrument to perform the following steps: 1. Perform the first piercing (ventilation). 2. Stop piercing. 3. Rotate the culture vessel. 4. Wait for the beads to settle. 5. Rotate the bottle to the optimal dispensing angle. 6. Continue moving forward to reach the second penetration (starting point of fractionation). 7. Aliquot. 8. Remove the collection container and culture bottle from the disposable. 9. Dispose of disposable equipment safely.

[0043] The molded housing can be made from the following materials: i) polypropylene (PP), or ii) an injection-molded composite, including, but not limited to, polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyethylene (PE), polystyrene (PS), nylon, and acetal. The needles 140, 150 are optionally 304 stainless steel, 316 stainless steel, Inconel 625, or Nitinol. The end of the vent needle 140 that terminates in the foam is optionally provided with an aluminum crimp on the barrel of the needle, a flared end, a fillet bond, or an interference fit to hold the needle in the insert. The dispensing needle is secured to the device using either an aluminum crimp on the barrel or a fillet bond. The antibacterial agent used in the foam is optionally bleach, ammonia, alcohol, hydrogen peroxide, or an antimicrobial gel. Examples of foam materials include, but are not limited to, low-density polyurethane, open-cell wood pulp, or sodium sulfate hemp fiber composite. Any or all of the three needle tips optionally have butyl rubber sleeves to further protect the needles from contamination. Optionally, such sleeves cover only the sides of the dispensing needles.

[0044] In another embodiment, the culture bottle 200 is held in an upright position for both venting and dispensing. In some situations, this position may be preferable, such as when the sample is highly concentrated or viscous and has the potential to clog the dispensing needle when the bottle is inverted. In such embodiments, at least the dispensing needle is longer, and optionally the dispensing and venting needles are longer. Optionally, in these embodiments, the dispensing and venting needles may be 100 mm or longer in length.

[0045] Referring to Figure 18, as in the other embodiments, a culture bottle 200 is received by the first port 120 of the two-port device 100. The two-port device has a vent needle 140 and a dispensing needle 150. Referring to Figure 19, the vent needle 140 and the dispensing needle 150 are significantly longer than those in the previously illustrated embodiments. The two-port device 100 is advanced toward the neck of the culture bottle 200 until the culture bottle cap 220 is at the distal end of the first port 120. Also in the embodiment illustrated in Figure 19, a microbial foam layer 170, 170' is disposed at both the distal end of the first port 120 and the distal end of the second port 130.

[0046] Referring to FIG. 20 , after the two-port device 100 is advanced to the dispensing position relative to the culture bottle 200 shown in FIG. 19 , a collection container 210 is inserted into the second port 130 of the two-port device 100. In these configurations, the length of the dispensing needle is sufficient to reach into the sample but not the portion of the sample containing the media / resin precipitate. Therefore, the order of piercing the culture bottle is the same as in the previous embodiment. That is, the vent needle pierces the culture bottle cap / septum first, which is then pierced by the dispensing needle. After the culture bottle cap / septum is pierced by the dispensing needle, a collection container (such as a vacutainer) is inserted into the second port of the disposable device. By holding the bottle and assembly upright, the high-viscosity / high-concentration homogenous mixture of media / resin / sample settles to the bottom of the culture bottle, allowing the less viscous, more free-flowing portion of the culture bottle contents to be dispensed.

[0047] Optionally, the disposable device 500 shown in Figures 21-23 includes a third port 535. The third port 535 allows for the venting action to be performed with a shorter, less expensive needle 540 inserted through the cap 522. The third port 535 includes a needle insert 561 and an antimicrobial foam layer 570 that collect aerosols exiting the vent needle 540. The vent needle 540 includes a sleeve 541 that collects contaminants after venting.

[0048] 22, after venting, the disposable 500 is disengaged from the culture bottle 200 and rotated so that the port 520 seals against the neck 560 of the culture bottle 200. As the port 520 is advanced downward toward the neck 560 of the culture bottle 200, the dispensing needle 550 pierces the cap 520 of the culture bottle 200, and the distal end of the dispensing needle enters the sample 521. Referring to FIG. 23, after the disposable 500 is advanced toward the neck 560 of the bottle 200 so that the cap 520 is adjacent the second needle insert 562, the collection container 510 is inserted into the port 530, and the proximal end of the dispensing needle 550 pierces the septum 531 of the collection container 510.

[0049] Referring to FIG. 24, optional disposable device 600 is a slight modification of disposable device 500 shown in FIGS. 21-23, but includes feature 608 that facilitates automating the rotation of device 600 when moving device 600 from the venting orientation to the dispensing orientation. Optionally, disposable device 600 is moved, but the culture bottle is not. In FIG. 24, feature 608 is a circular knob that can be grasped by a three-finger gripper that can grasp device 600 in an orientation where third port 635 is oriented in the required direction to receive and engage a culture bottle, and once the culture bottle is vented, disengage port 635 of disposable device 600 from the culture bottle, rotate disposable device 600, and then engage port 620 with the culture bottle so that the dispensing needle therein pierces the cap of the culture bottle. Since the objective is to vent the culture bottle, the culture bottle is positioned with the neck of the culture bottle facing up, so that the sample within the culture bottle is not in communication with the vent needle.

[0050] Referring to Figure 25, because not many culture bottles in process produce aerosols, the risk of dispensing without venting may be acceptably small. As an optional option, a disposable device with two chambers and only one needle 750 is envisioned. The disposable device 700 has a first port 720 and a second port 730. The first port 720 receives a collection bottle (not shown). The second port 730 receives a collection device (not shown). The needle insert 760 has an antimicrobial-infused foam 770 on the second port 730 side of the needle insert 760 to capture aerosols that may be vented through the needle as the dispensing needle 750 pierces the cap of the culture bottle.

[0051] Figure 26 is a diagram of a disposable device 800 with a collection port 830 adapted to receive a syringe 810 and a port 820 adapted to receive a culture bottle. A neck 860 of the culture bottle with a cap 822 is shown in Figure 26. A dispensing cannula 850 pierces a needle insert 861. Antimicrobial foam 870 is disposed at the distal end of port 830 that receives the syringe. The dispensing cannula is in fluid communication with syringe 810. Syringe 810 is subjected to below atmospheric pressure (i.e., a partial or full vacuum), thereby aspirating a sample from the culture bottle through cannula 850. Once syringe 810 has drawn an aliquot from the culture bottle, syringe 810 is removed from device 800 for downstream processing.

[0052] FIG. 27A is a diagram of a disposable device 800 positioned in a culture bottle 200, where the collection port 830 has a luer lock fitting 825 that fluidly couples a collection device 910 (shown as a needleless syringe with a luer connector 911) to the contents of the culture bottle 200. The disposable device has two needles, a vent needle 840 and a dispensing needle 850. Referring to FIG. 27B, a cannula 850 that provides a fluid path from the culture bottle 200 to the collection device 910 terminates in the luer lock 825. The collection device 910 is placed in fluid communication with the cannula 850, and a sample aliquot is aspirated. Referring to FIG. 3, the disposable device 800 / culture bottle 200 / collection device assembly 910 is rotated so that the cannula 850 is in fluid communication with the contents of the culture bottle 200 for dispensing. Thereafter, referring to FIG. 27C, the collection device 910 is disconnected from the luer connector 825 of the disposable device 800, and the collection device 910 is used to transport the collected sample for downstream processing.

[0053] In this specification, the term "comprising" is to be understood in the "open" sense, i.e., in the sense of "including," and therefore not in the "closed" sense, i.e., in the sense of "consisting only of." A corresponding meaning is to be ascribed to the corresponding words "comprise," "comprised," and "comprises."

[0054] While particular embodiments of the present technology have been described, it will be apparent to those skilled in the art that the technology may be embodied in other specific forms without departing from its essential characteristics. Accordingly, the embodiments and examples described herein are to be considered in all respects as illustrative and not restrictive.

[0055] Furthermore, reference herein to known subject matter in the technical field of the invention is to be construed as an acknowledgement that said subject matter is well known to those of ordinary skill in the art, unless otherwise indicated.

Claims

1. 1. A multi-port disposable device for venting and dispensing aliquots from a sealed sample device, comprising: A housing including a plurality of ports, the plurality of ports comprising: a culture vessel port configured to receive the top of a culture vessel, the culture vessel port including a first culture vessel port having a proximal end open to receive the culture vessel and a distal end terminating in a first needle insert, or, in addition to the first culture vessel port, a second culture vessel port having a proximal end open to receive the culture vessel and a distal end terminating in a second needle insert; a sample collection container port configured to receive a sample collection container, the sample collection container port having a proximal end open to receive the sample collection container and a distal end terminating in the first needle insert; a housing including: a vent needle disposed within the housing, the vent needle including a cannula extending through either the first needle insert or the second needle insert, the proximal end of the cannula of the vent needle configured to pierce a septum or cap of the culture vessel received in the culture vessel port, and the distal end of the cannula of the vent needle terminating on the side of the either needle insert opposite the side facing the proximal end of the culture vessel port; a dispensing needle disposed within the housing, the dispensing needle including a cannula extending through the first needle insert and providing fluid communication between the culture vessel received in the first culture vessel port and the sample collection vessel received in the sample collection vessel port, wherein one end of the cannula of the dispensing needle is configured to pierce a septum or cap of the culture vessel and the other end of the cannula of the dispensing needle is configured to be in fluid communication with the sample collection vessel; Equipped with A multi-port disposable device wherein the cannula of the vent needle does not extend beyond either needle insert into the specimen collection container port.

2. 10. The multi-port disposable device of claim 1, further comprising a foam layer carrying an antimicrobial agent positioned adjacent to the first needle insert sandwiched between the first culture container port and the specimen collection container port.

3. 3. The multi-port disposable device of claim 2, wherein a foam layer carrying the antimicrobial agent is disposed at the distal end of the specimen collection container port, and the cannula of the vent needle terminates in the foam layer.

4. 3. The multi-port disposable device of claim 2, wherein the first needle insert is held in an opening from the distal end of the first culture container port to the distal end of the specimen collection container port.

5. The multi-port disposable device of claim 1 , wherein the vent needle is retained in the second needle insert, and the vent needle is not in fluid communication with the specimen collection container port.

6. The multi-port disposable device of claim 5, wherein a foam layer carrying an antimicrobial agent is adjacent to the second needle insert.

7. The multi-port disposable device of claim 1 , wherein at least one of the vent needle and the dispensing needle has a sheath thereon.

8. The multi-port disposable device of claim 1 , wherein the sample collection container is a syringe.

9. 9. The multi-port disposable device of claim 8, wherein the sample collection container port is a connector adapted to connect to the sample collection container, the connector being in fluid communication with the dispensing needle, a proximal end of the connector being in fluid connection with the syringe, and a distal end of the connector being in fluid connection with the dispensing needle.

10. The multi-port disposable device of claim 9, wherein the connector is a luer connector.

11. The multi-port disposable device of claim 8, wherein the dispensing needle is a syringe needle carried by the syringe.

12. The multi-port disposable device of claim 10, wherein the cannula of the dispensing needle extends from the connector that receives and connects to the sample collection container at the sample collection container port.

13. 1. A multi-port disposable device for venting and dispensing aliquots from a sealed sample device, comprising: A housing including a plurality of ports, the plurality of ports comprising: a culture vessel port configured to receive the top of a culture vessel, the culture vessel port having a proximal end open to receive the culture vessel and a distal end terminating in a needle insert; a sample collection container port configured to receive a sample collection container, the sample collection container port having a proximal end open to receive the sample collection container and a distal end terminating in the needle insert; a housing including: a vent needle disposed within the housing, the vent needle including a cannula extending through the needle insert, the proximal end of the cannula of the vent needle configured to pierce a septum or cap of the culture vessel, and the distal end of the cannula of the vent needle terminating at a distal end of the specimen collection container port; a dispensing needle disposed within the housing, the dispensing needle including a cannula extending through the needle insert and providing fluid communication between the culture vessel received in the culture vessel port and the sample collection vessel received in the sample collection vessel port, one end of the cannula of the dispensing needle configured to pierce a septum or cap of the culture vessel, and the other end of the cannula of the dispensing needle configured to be in fluid communication with the sample collection vessel; Equipped with A multi-port disposable device, wherein the cannula of the vent needle extends further into the culture vessel port in a direction from the needle insert toward the proximal end of the culture vessel than the dispensing needle.

14. 14. The multi-port disposable device of claim 13, wherein the distal end of the cannula of the vent needle terminates in a foam layer carrying an antimicrobial agent located adjacent the needle insert sandwiched between the culture container port and the specimen collection container port.

15. 15. The multi-port disposable device of claim 14, wherein the foam layer carrying the antimicrobial agent is disposed at a distal end of the specimen collection container port, and the distal end of the cannula of the vent needle terminates in the foam layer carrying the antimicrobial agent.

16. 16. The multi-port disposable device of claim 15, further comprising a second foam layer, said second foam layer positioned at a distal end of said specimen collection container port and adjacent said needle insert.

17. 14. The multi-port disposable device of claim 13, further comprising a flange between said culture container port and said specimen collection container port, said needle insert secured to said flange.

18. The multi-port disposable device of claim 13, wherein at least one of the vent needle and the dispensing needle has a sheath thereon.

19. 14. The multi-port disposable device of claim 13, wherein the sample collection container is a syringe and the dispensing needle is a syringe needle.

20. 1. A multi-port disposable device for venting and dispensing aliquots from a sealed sample device, comprising: A housing including a plurality of ports, the plurality of ports comprising: a first culture vessel port configured to receive the top of a culture vessel, the first culture vessel port having a proximal end open to receive the culture vessel and a distal end terminating in a first needle insert; a sample collection container port configured to receive a sample collection container, the sample collection container port having a proximal end open to receive the collection container and a distal end terminating in the first needle insert; a second culture vessel port configured to receive the culture vessel, the second culture vessel port having a proximal end open to receive the culture vessel and a distal end terminating in a second needle insert; a housing including: a vent needle disposed within the housing, the vent needle being retained by and extending from the second needle insert disposed within the second culture vessel port into the second culture vessel port, the vent needle including a cannula configured to penetrate the second needle insert and pierce a septum or cap of the culture vessel; a dispensing needle disposed within the housing, the dispensing needle including a cannula extending through the first needle insert and providing fluid communication between the culture vessel received in the first culture vessel port and the sample collection container received in the sample collection container, wherein one end of the cannula of the dispensing needle is configured to pierce a septum or cap of the culture vessel and the other end of the cannula of the dispensing needle is configured to pierce a septum or cap of the sample collection container; A multiple port disposable device comprising:

21. 21. The multi-port disposable device of claim 20, wherein the cannula of the vent needle terminates in a foam layer carrying an antimicrobial agent disposed adjacent the second needle insert.

22. 21. The multi-port disposable device of claim 20, further comprising a flange between the first culture container port and the specimen collection container port, the first needle insert being secured to the flange.

23. 21. The multi-port disposable device of claim 20, wherein at least one of the vent needle and pre-dispensing needle has a sheath thereon.

24. 1. A multi-port disposable device for venting and dispensing aliquots from a sealed sample device, comprising: A housing including a plurality of ports, the plurality of ports comprising: a culture vessel port configured to receive the top of a culture vessel, the culture vessel port having a proximal end open to receive the culture vessel and a distal end terminating in a needle insert; a sample collection container port configured to couple to a sample collection container, the sample collection container port comprising a fluid connector; a housing including: a vent needle disposed within the housing, the vent needle comprising a cannula extending through the needle insert, the proximal end of the cannula of the vent needle configured to pierce a septum or cap of the culture vessel, and the distal end of the cannula of the vent needle terminating at the distal end of the specimen collection container port; a dispensing needle coupled to the fluid connector, the dispensing needle including a cannula extending from the fluid connector and providing fluid communication between the culture vessel received in the culture vessel port and the fluid connector; Equipped with A multi-port disposable device, wherein the cannula of the vent needle extends further into the culture vessel port in a direction from the needle insert toward the proximal end of the culture vessel port than the dispensing needle.

25. 25. The multi-port disposable device of claim 24, wherein the cannula of the vent needle terminates in a foam layer carrying an antimicrobial agent positioned adjacent to the needle insert sandwiched between the culture vessel port and the fluid connector.

26. 26. The multi-port disposable device of claim 25, wherein the foam layer carrying the antimicrobial agent is disposed at a distal end of the fluid connector, and the cannula of the vent needle terminates in the foam layer carrying the antimicrobial agent.

27. 27. The multi-port disposable device of claim 26, wherein the fluid connector is a luer connector.

28. 25. The multi-port disposable device of claim 24, further comprising a flange between said culture vessel port and said fluid connector, said needle insert being secured to said flange.

29. 25. The multi-port disposable device of claim 24, wherein at least one of the vent needle and the dispensing needle has a sheath thereon.

Images