Disposable device for venting and dispensing from sealed containers

Abstract

To provide a multi-port disposable instrument for safely performing both ventilation of a culture container and fractionation of a sample in the culture container.SOLUTION: A multi-port disposable having a first port configured to receive and attach to a top portion of a culture vessel and a second port configured to receive a sample collection vessel, wherein the first port receives a portion of the culture vessel and the second port receives the collection vessel. The device has a first needle and a second needle. The first needle has a cannula configured to pierce the septum or cap of the culture vessel and the second needle comprises 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 the 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 to deliver the sample from the culture vessel to the collection vessel.SELECTED DRAWING: Figure 4

Description

[Technical Field]

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

[0002] The invention described herein provides a method for aerating a culture vessel and obtaining samples from the culture vessel. 2. A vent needle and a separate fluid transfer needle for both (injecting an aliquot of sample) This relates to ported disposable devices. [Background technology]

[0003] Various embodiments of the present disclosure provide methods for analyzing samples (e.g., biological samples, environmental samples, The present invention describes a system and method for testing food samples and other foods inoculated into culture vessels. If the sample is contaminated with microorganisms, the condition of the culture vessel will change over time. When microorganisms are present in the sample, their metabolic activity is influenced by the gas composition, gas pressure, and and / or pH changes (if microorganisms are present in the sample) in the gas in the incubation vessel. As the pressure increases over time, the contents of the culture vessel are heated to the temperature of the culture vessel before being removed from the culture vessel. Gas from the culture vessel cannot touch the contents of the culture vessel without venting. A device that allows safe ventilation of a culture vessel and the collection of samples from the culture vessel is required.

[0004] The detection of a positive blood culture (PBC) determines the identity of the microorganism in the culture vessel and identifies that microorganism. It is a long process to determine the appropriate drug treatment for an infected patient. The first step is to identify and characterize the antibody-sensitive protein for downstream processing by instrumentation. The first step is to remove the microorganisms from the bottle and place them in a suitable collection container.

[0005] BD BACTEC TM Bactec bottles (Becton Dickinson) In blood culture vessels, such as the NIH-10001, the growth of bacteria is accelerated by the carbon dioxide (in the sample). Depending on the type of microorganism, different gases (such as CO2) are produced. The production of these gases by the microorganisms causes a slight increase in the internal pressure of the culture vessel. Perforation of the bottle septum to release or contain the oxidized bacterial culture. This should be done to prevent contamination of internal instrument surfaces and potential sample cross-contamination. Prevent the contents of blood culture bottles from leaking into the surrounding environment. Access to the object is of paramount importance. Solutions to this problem are continually being sought. It is being done. Summary of the Invention

[0006] In a microbiology laboratory environment, inoculated blood culture bottles are used to promote bacterial growth. Positive blood cultures are then cultured for downstream identification and susceptibility testing. Aliquots are taken from the bottles for testing. The disposable devices are used in the preparative stage of blood culture processing. The disposable device has a housing with at least two needles disposed therein. It has two opposing receiving portions (sometimes called ports or sleeves) One of the receiving parts is configured to be attached to a blood culture container such as a blood culture bottle. First, the long needle of the disposable device pierces the septum of the culture bottle. When the needle is opened, it leaks out and the aerosol is released containing an antibacterial agent. The disposable instrument and blood culture container assembly is trapped in a thick layer of open-cell foam during ventilation. The yellowtail is placed in a nearly upright position so that gas can escape upwards.

[0007] Optionally, after venting, the 2-port disposable device and blood culture vessel assembly , the disposable is held below the blood culture bottle, and the liquid contents of the blood culture are not transferred to the disposable. Optionally, the device is inverted at least somewhat so as to be in fluid communication with the needle of the device. After collection, the blood culture container remains in an upright position for collection. The sealed sterile collection container , the second needle of the two-port disposable device so that the seal of the collection container is pierced by the second needle. The second sleeve of the collection vessel is inserted into the second sleeve of the port. The vacuum in the collection vessel pulls the blood culture aliquot into the culture vessel. Remove from the culture container and place in a sterile collection container.

[0008] For example, some embodiments may involve piercing a septum or cap of a culture vessel and separating the sample. A two-port disposable device is described that includes a means for allowing degassing of the culture vessel prior to collection. This allows the pressure inside the culture vessel to be released before an aliquot of the culture vessel contents is withdrawn. In some embodiments, the gas in the headspace of the culture vessel is A two-port disposable device that does not contaminate the environment outside the assembly and does not cause sample contamination. can be expelled from

[0009] In some embodiments, the two-port disposable device is carried by the released vapor. It has a membrane that prevents liquid from leaking out of the two-port disposable device. The instrument then draws an aliquot of the sample from the culture vessel (typically combined with the culture medium). and collection vessels for subculture or sorting for other diagnostic processes, such as molecular diagnostics. Used to put into

[0010] One example of a two-port disposable device described herein receives the top of a culture vessel and The two-port disposable device has a first port configured to be attached to a test and a second port configured to receive a sample collection container. The cannula is configured to penetrate the septum or cap of the culture vessel. The antimicrobial agent is transferred from the culture vessel through a cannula to form a folic acid. The foam is then terminated in a layer of this foam to be absorbed and neutralized by the The ports of the disposable device are configured as sleeves. The sleeve of the first port is The second port receives a portion of the culture vessel, and the sleeve of the second port receives a collection vessel. The needle penetrates both the septum or cap of the culture vessel and the septum or cap of the collection vessel. The second cannula provides fluid communication between the culture vessel and the collection vessel. The first cannula provides a flow path for the sample to be delivered to the collection vessel. provides a flow path into the culture vessel.

[0011] Optionally, the collection vessel is a syringe. In this embodiment, the second cannula The syringe terminates in the culture vessel to deliver the culture vessel to the collection vessel. Optionally, a second cannula may be inserted to convert the syringe into a disposable device. The container is terminated with a connector such as a Luer lock connector that connects to the culture vessel. A vacuum source sufficient to draw the desired aliquot from the connector is also provided. The syringe 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] 1 is a cutaway view of a two-port disposable device according to one embodiment of the present invention. The device 100 includes a housing 110 having a first port 120 and a second port 130. Optionally, the housing 110 is a single piece. The second port 130 is configured like a sleeve. The first needle 140 is a needle for dispensing the sample, and the second needle 150 is a dispensing needle. A needle-holding insert separates the port 120 from the second port 130 (into which the needle is inserted). The needle retaining insert is held within the housing 110 by the first port 160. The ports 120 are secured by flanges 161 formed at the distal ends thereof and the second ports. The flange 161 prevents the container from entering the first and second ports from going too far and reaching the adjacent ports. Optionally, the two-port disposable device 100 may include a second a disposable antimicrobial forma- tion located at the distal end of the port 130 and adjacent to the needle insert 160; The vent needle 140 also has a needle 170. Both needles pass through the needle insert 160. The vent needle 140 is The needles terminate in an antimicrobial disposable foam 170. Pass through.

[0014] Optionally, the two-port disposable device may include a molded housing 110 with two port disposables. The disposable device has external features that facilitate automated grasping and manipulation. Examples of such features include: , as illustrated in FIG. 1. Illustrated in the figure are a gripper center rib 180, a detent ring 190, and Key 195.

[0015] Referring to FIG. 2, the assembly of the two-port disposable device 100 described in FIG. It is shown assembled to a vial 200 and collection tube 210. 0, it pierces only the cap 220 of the culture bottle 200 and the septum of the collection tube 210. The disposable needle 150 is placed in the two-port disposable device 110 so as not to pierce the needle 230. , piercing 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 the sleeve of the first port 120, and the collection tube 210 is received by the second port 130. The first port 120 and the second port 130 are The port is formed like a sleeve within the one-piece housing 110 of the disposable 100. As described above, the vent needle 140 and the collection needle 150 are connected to each other by the needle insert 160. The antimicrobial disposable foam 170 is retained within the disposable device. Optionally, an antimicrobial phosphatase is located at the distal end of the second port 130 adjacent to the The arm may be located at the distal end of the first port 120 .

[0016] The two-port disposable device addresses the aerosolization problem. Bacterial growth in the culture bottles is stimulated by either carbon dioxide or oxygen (depending on the type of bacteria). This generates gases such as oxygen and creates a slight pressure inside the bottle. To prevent surface contamination, try to eliminate aerosolized bacteria and culture media. The septum of the culture bottle must be pierced so that the contents are enclosed. The device is a two-port disposable device in which aerosolized bacteria and culture media are trapped within a foam chamber. Disposable antibacterial agent is injected into the ventilation side of the ventilation needle to prevent it from entering the device's surrounding environment. Inserting a form addresses this issue.

[0017] Two-port disposable devices address the contamination issue. As mentioned above, aerosols enter the vent port. If bacteria are transported from the facility to the surrounding environment, there is a risk of microbial contamination as described above. The chlorosol collection foam minimizes microbial contamination of the culture and collection vessel surfaces, The aerosol collection foam also prevents contaminants from entering the culture vessel during aeration. This reduces or eliminates the presence of bacteria remaining in the culture bottle after the initial sample has been taken. This allows the sample being cultured to be aliquoted from the culture vessel.

[0018] The two-port disposable device includes the gripper center rib 180, anti-rotation ring 190, and and key 195. These features facilitate automation. With a high degree of confidence, remove the two-port disposable device from its packaging and vent it. Grasp and manipulate the two-port disposable device to extract the culture vessel, and This facilitates the use of automated equipment for disposal of the equipment.

[0019] The two-port disposable device uses a needle that does not "pierce" the septum / stopper of the culture / collection vessel. A hole occurs when the piercing instrument leaves a permanent path through the septum / stopper. Puncture of the septum / stopper, leaving a tear or other damage to the stopper, may result in leakage. So it must be avoided.

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

[0021] Even in automated systems, needle safety is an issue. Disposable devices minimize the technician's exposure to exposed tips.

[0022] To ensure that a sufficient aliquot of sample is aspirated into the collection vessel, The device 100 is assembled to a culture vessel 200 and a collection vessel in the manner illustrated in FIG. In step 1, the two-port disposable device 100 is assembled into the culture vessel 200. The vent needle 140 is inserted through the cap 220 of the culture bottle. In cap 2, the two-port disposable device 100 has a collection needle 150 inserted into the cap 2 of the culture bottle. 20. In step 3, The port disposable 100 and culture vessel 200 assembly allows the beads in the medium / sample to grow. The mixture is then rotated / shaken to settle at the bottom of the fertilizer bottle 200. The assembly of the device 100 and the culture vessel 200 is then horizontally oriented as shown in step 4. In step 5, the collection container 210 is positioned at a negative angle relative to the collection needle 150. the second port of the two-port disposable device 110 so that the The collection container 210, the two-port disposable device 100, and the culture vessel 130 are inserted into the port 130. The vessel 200 assembly is maintained at a negative angle during sample collection, and then in step 6 In step 7, the collection vessel 210 is removed from the assembly. The 00 is removed from the two-port disposable device and the two-port disposable device is discarded.

[0023] Figure 4 shows the two-port disposable device being advanced to insert the culture medium to perform the first aeration step. The first separation step is shown in FIG. In the aeration step, only the first aeration needle 140 pierces the cap 220 of the culture vessel 200. The distal end of the vent needle 140 is adapted to prevent aerosols released as a result of venting the culture vessel 200 from entering the antibacterial captured in terrier foam, thereby reducing / eliminating the risk of contamination through ventilation , embedded in disposable antimicrobial foam 170. The vent needle is deeper than the dispensing needle. Extending into the first port 120, the two-port disposable device can be further advanced to first When contacting the culture vessel 200, the culture vessel 200 is vented. The cap 220 of the culture vessel is not pierced until it is inserted into the second port 130, and this insertion The sorting needle is then pierced through the cap 220 of the culture vessel.

[0024] In an automated method, a robotic gripper (not shown) holds the two-port disposable device 100. and positioning the first port 120 concentrically above the upright culture vessel 200. The two-port disposable device 100 is configured such that the vent needle 140 comes into contact with the cap of the culture vessel and pierces it. The cap 220 is translated along the Z axis so as to penetrate the vent needle 140. At the same time, if pressurized gas is present, it will escape through the vent needle 140 and the aerosol will Preferably, the open-cell foam contains an antibacterial agent (i.e., a disposable antimicrobial foam). The particles are collected in a layer of suitable thickness on foam 170.

[0025] FIG. 5 shows a two-port sterilization system with a disposable antimicrobial foam 170 located at the distal end of the second port 130. 1 is a detailed view of a portion of the needle disposable 100. The needle insert 160 is inserted into the first port 1. 20. A layer of antibacterial saturated foam is placed on top of the collection container. Apply pressure to the closure (e.g., reseal the septum cap or vacutainer) (Ctton Dickinson BD). The automated device uses needles 140 and 150, respectively. and a disposable antimicrobial foam layer 170 is applied to the needle before removal from the culture and collection vessels. Rotating the housing 110 so as to sweep the top surface of the insert 160 radially 5 shows that the interior of the housing 110 is closed to the small diameter portion of the needle insert 160. 250. The needle insert 160 has a flange 240 extending through the flange 240. The diameter 260 secures the needle insert to the housing 100 and connects the first port 120 and the second port 122. 1 and 2. The port 130 is positioned on a flange 240 to provide a seal between the port 130 and the flange 240.

[0026] 6 is a detailed cutaway view of needle insert 160. The insert 160 is secured, thereby forming a seal between the first port 120 and the second port 130. To provide the chain, the large diameter portion of the needle insert 160 rests on the flange 240 (FIG. 5). 260 is shown. The dispensing needle 150 has a sheath 151 thereon. The sheath is disposable. The sheath seals the collection needle when the device is secured to the culture vessel. Before attaching the needle to the device, prevent the contents of the culture vessel from spilling out of the culture vessel. One example of a suitable material for the rubber 160 is butyl rubber. The optional sheath placed over the needle may also be made of butyl rubber. Alternatively, Bactec is used before compressing the foam cylinder and needle that pierces the septum. TM B A thick foam layer can be implemented over the needle that provides a cleaning action against the top of the needle. 7 illustrates the needle insert of FIG. 6 in perspective view.

[0027] 8 is a diagram of the housing 110. As shown, the housing includes a first port 1 20 and a second flange 265 at the proximal end of the second port 130. The flange 265 has a symmetrical shape. The second flange 190 has an asymmetric shape. The asymmetric flange 190 The asymmetrical frame has two adjacent portions on opposite sides of the proximal end of frame 130. The lunge 190 is received by an automated instrument that positions the instrument 100 in a blood culture container and engages a locking mechanism. The gripper center rib 180 can be used to capture each sample aliquot obtained using the instrument. The jaws of the gripping mechanism grip the coat in a coaxial position with the two-port disposable device. This makes it possible.

[0028] The outer diameter key feature 195, in combination with the gripper geometry, allows the two-port disposable device 100 This allows the vent needle to be lifted in the same radial direction for each sample. It is expected that the nozzle will be inserted into the bin at the same radial angle.

[0029] As mentioned above, optionally, the needle does not pierce the septum through which it penetrates. Measures in both needle and septum design will be noted that will reduce the instances of septum perforation. One example of a needle 300 designed to manage or reduce perforation is shown in Figure 9. The needle 300 , having a first bevel 310, a second bevel 320, and a heel feature 330. To reduce this, the heel feature 330 is configured to facilitate displacement of the diaphragm material without cutting the diaphragm material. Then, the edges are bead blasted to dull them.

[0030] The cap 220 may be made of a conventional diaphragm material such as brominated butyl rubber or chlorinated butyl rubber. Typically, such materials have a durometer Shore of about 40 to about 50. Such a material also has a hardness of A. Materials with lower durometers are less likely to be punctured. (or puncture-resistant). Lubricants such as silicone and Teflon are less likely to puncture. To reduce force, ease insertion, and reduce the chance of perforation and tear, To address these challenges, a needle is used on the outer surface of the needle to prevent the needle from perforating the septum. Grinding of the heel of the bevel is also considered.

[0031] One potential problem with aspirating samples from culture vessels is that the resin in the culture medium can clog the needle. The solution to this problem is to equip the needle with a large diameter cannula. In both cases, the needle opening must be large enough to prevent resin from entering the cannula, or or small enough that the resin cannot enter the cannula.

[0032] 10A and 10B show the bin 110 initially in a 45 degree upward angle position, with the bin 110 relatively The process of generating a bead-poor suspension 350 is illustrated (FIG. 10A). The relatively sediment-free portion of sample 350 is rotated approximately 20 degrees downward. , flowing into the neck 360 of the bottle 110. This allows the needle 150 to be shortened, The needle does not aspirate from the lower portion of the suspension containing the resin / medium 370 precipitate. When oriented as shown in FIG. 0B, the second bevel 320 acts to absorb the suspended resin beads. For more control over the draw, point the sample upwards. For this purpose, the angle of the bottle neck 360 relative to the horizontal is set to about 9.5 degrees to about 20 degrees. Such orientation of the nutrient bottle 200 is shown in Figure 11A (9.5 degrees), Figure 11B (12.5 degrees), and 11C (20 degrees).

[0033] 12 is a diagram of the culture bottle 200 turned upside down (180 degrees rotated). The resin settles in the neck 360 of the culture bottle 200 (i.e., the resin fills the neck to a depth of about 57 mm). At that point, insert the dispensing needle (150 in Figure 10B) , bypassing the resin / medium 370 and collecting the sample from a relatively sediment-free portion of the sample 350. In this embodiment, the sample can be inserted into the culture bottle approximately 65 mm. In order to reach the relatively sediment-free portion of the sample, a dispensing needle approximately 100 mm in length is required.

[0034] 13A-13D show different types of needles that can be used as the dispensing needles 150 described herein. 13A-13B illustrate a slotted needle with a needle opening 410. A side view (FIG. 13A) and a top view (FIG. 13B) of needle 400 are shown. 13C and 13D are side and top views of a Whittaker needle 420 having a needle opening 430. is illustrated.

[0035] FIG. 14 shows another optional needle design having multiple openings 440 in the side of the needle / cannula. Optionally, the needle is a side pencil point needle. Size 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 are A closed pencil tip 450 is provided for aspirating fluid into a collection vessel (not shown), and a typical Typically, there is a single side hole 440. Other examples of needle point styles include the Pe ncan® (registered trademark of B. Braun Medical Inc.), Gert These needle designs are well known to those skilled in the art and are described herein. These needle types are typically used for spinal applications and require a minimum of 25 Optionally, the present specification may be modified to provide a gauge (0.515 mm) size. The needles shown in are approximately 20 gauge. Optionally, the needles shown in FIGS. 13A-13D The needle may have multiple apertures.

[0036] For the embodiment shown in FIG. 14, the single pencil point design is approximately 0.15 mm. The diameter of the beads is about 0.2 to about 0.6 mm, so the test Resin from the material / medium does not enter the opening 440 of the single pencil point design. The needle geometry described herein is designed to pierce the septum of the culture bottle 200 and collection container 220. will be considered as appropriate.

[0037] The needles 140 and 150 are held within the housing 110 so that the user of the device can 140 and the sharp end of needle 150. The 40 and 150 models also feature a butyl rubber sleeve to protect users from accidental punctures. It is covered with a tube.

[0038] Optionally, the disposable devices described herein may be used in automated processes. In such a process, the procedure of which is illustrated in FIG. This is done before the first port 120 has advanced sufficiently toward the neck 360 of the culture bottle 200. After the needle 140 has vented the culture bottle 200, the culture bottle 200 is slowly rotated, After the bin 200 is tilted to about 45 degrees, the rotation stops for about 30 seconds, The resin beads / medium 370 are allowed to settle to the corners of the culture bottle 200 .

[0039] Rotation is then resumed to a predetermined fraction angle. In this example, the fraction angle is approximately 20 degrees. Next, the disposable device is configured such that the dispensing needle 150 is inserted into the cap 220 of the culture bottle 200 (i.e., The second needle advances further toward the neck 360 of the culture bottle, piercing the septum. Upon piercing, fluid flows from the culture bottle 200 into the collection tube 210. After collection, the collection tube The tube 210 is removed from the disposable device 100. The culture bottle 200 is then The user then inserts the tip into the disposable device, along with the embedded tip. Dispose of disposable equipment according to medical waste disposal procedures.

[0040] 15 is a detailed cross-sectional view of the second port 130 of the disposable device 100. The needle ends in a needle insert 160 that connects to a collection container (not shown). The needle insert 160 is positioned adjacent to the distal end of the port 130. 150 is in fluid communication with both the illustrated second port and the first port 120 (FIG. 17). .

[0041] FIG. 16 is a cross-sectional view of FIG. 15, showing the disposable device from the side of the second port 130. The arrangement of the dispensing needle 150 is shown in the figure. The dispensing needle 150 has a bevel as described above. This reduces the risk of handling the sharp tip.

[0042] FIG. 17 is a cross-sectional view of the first port 120 of the disposable device. 1 shows placement of a vent needle 140 from the side of the port 120. The needle is secured by a needle insert 160. As mentioned above, the disposable foam is held in place by the device. Two ports extending into the first port 120 are provided to absorb the aerosols being vented. The difference in the length of the needles (140, 150) and the two-port disposable instrument advance into the culture vessel 200 The rate of contact determines the length of time the culture vessel 200 is vented. The difference in length of the needle is sufficient to allow the automated equipment 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 may be made from the following materials: i) Polypropylene (PP); ii) Polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene ABS, polyethylene (PE), polystyrene (PS), nylon, and injection molding composites, including but not limited to acetal. Optional choices include 304 stainless steel, 316 stainless steel, and Inconel 625 The end of the vent needle 140 that terminates in foam is optionally by using an aluminum crimp on the barrel of the needle, a flared end, a fillet bond, or The needle is fitted with an interference fit to hold it in the insert. The needle is attached to an aluminum insert on the barrel. It is secured to the device using either aluminum crimping or fillet bonding. Antibacterial agents include bleach, ammonia-based, alcohol-based, and peroxide-based options. Hydrogen or antimicrobial gel. Examples of foam materials include low density polyurethane, continuous Examples include, but are not limited to, aerated wood pulp, or sodium sulfate hemp fiber composite. Any or all of the three needle points may be used to protect the needle from contamination. It has a butyl rubber sleeve for additional protection. The ribs only cover the sides of the dispensing needle.

[0044] In another embodiment, the culture bottle 200 is in an upright position for both aeration and dispensing. In some situations, this position is useful when the sample is highly concentrated or viscous. This is suitable for cases where there is a potential for the dispensing needle to become clogged when the bottle is turned upside down. In such an embodiment, at least the dispensing needle is longer and optionally Alternatively, the dispensing needle and the vent needle may be longer. In this embodiment, the collection needle and the vent needle may be 100 mm or longer.

[0045] Referring to FIG. 18, as in other embodiments, the culture vessel 200 is a two-port device. The two-port device is received by the first port 120 of the device 100. The two-port device includes a vent needle 140 and a dispensing needle. 19, the vent needle 140 and the collection needle 150 are the same as those shown in the previous figures. The two-port device 100 is considerably longer than the embodiment. 1 advances toward the neck of the culture bottle 200 until it reaches the far end of the port 120. In the embodiment illustrated in FIG. 19, the microbial foam layer 170, 170' is The first port 120 and the second port 130 are both located at their far ends.

[0046] Referring to FIG. 20, the two-port device 100 is connected to the culture vessel 200 shown in FIG. After advancing to the dispensing position, the collection vessel 210 is inserted into the second port 130 of the two-port device 100. In these configurations, the length of the needle is long enough to reach into the sample. However, the sample part with the medium / resin precipitate is not reached. The order of venting is the same as in the previous embodiment. That is, first, the vent needle is vented into the culture bottle. The cap / septum is pierced, and then the cap / septum of the culture bottle is pierced with the dispensing needle. After the cap / septum of the culture bottle is pierced by the dispensing needle, The collection container is inserted into the second port of the disposable. The container and assembly are then aligned vertically. By keeping the flask upright, a highly viscous and highly concentrated homogenous mixture of medium, resin, and sample is formed in the culture bottle. Sediment forms at the bottom and the less viscous, more free-flowing portion of the culture bottle contents is collected. This makes it possible.

[0047] Optionally, the disposable device 500 shown in FIGS. 21-23 may include a third port 53 5. The third port 535 is a shorter, more flexible port that is inserted through the cap 522. The third port 535 allows for the venting operation to be performed with a less expensive needle 540. 40 includes a needle insert 561 and an antimicrobial foam layer 570 for capturing aerosols emitted from the needle. Vent needle 540 has a sleeve 541 that collects contaminants after venting.

[0048] In FIG. 22, after venting, the disposable device 500 is disengaged from the culture bottle 200. The port 520 is then closed and rotated to seal the neck 560 of the culture bottle 200. When the needle 550 is advanced downward toward the neck 560 of the culture bottle 200, the needle 550 The cap 520 of the culture bottle 200 is pierced, and the distal end of the needle enters the sample 521. 23, the disposable cap 520 is positioned adjacent to the second needle insert 562. After the tool 500 is advanced toward the neck 560 of the bottle 200, the collection container 510 is The needle 550 is inserted into the collection container 510 so that the proximal end of the needle 550 pierces the septum 531 of the collection container 510. .

[0049] Referring to FIG. 24, optionally, a disposable device 600 may be provided as shown in FIGS. A slight modification of the disposable device 500 shown is shown, which operates the device 600. A feature that facilitates automating the rotation of the device 600 from the venting orientation to the dispensing orientation. Optionally, the disposable device 600 may be moved but not moved to a culture vessel. In FIG. 24, feature 608 indicates that the third port 635 is configured to receive the culture bottle. The orientation of the instrument 600 when oriented as required for receiving and engaging it. Once the culture bottle is aerated, it can be used. The port 635 of the disposable device 600 is disengaged from the culture bottle, and the disposable device 600 is rotated. and then insert the needle into port 620 so that the needle pierces the cap of the culture bottle therein. It is a circular knob that can be engaged with the culture bottle. Its purpose is to vent the culture bottle. Therefore, the culture bottle is positioned with the neck of the culture bottle facing upward. The sample in the tube does not communicate with the vent needle.

[0050] Referring to Figure 25, there are not many culture bottles in the process that generate aerosols, so there is no need for ventilation. The risk of fractionation may be acceptably small. , a disposable device having two chambers and only one needle 750 is envisioned. The device 700 has a first port 720 and a second port 730. The first port 720 , receives a collection bottle (not shown). A second port 730 receives a collection tool (not shown). The needle insert 760 is provided to prevent the collection needle 750 from piercing the cap of the culture bottle. The first portion of the needle insert 760 is provided to capture any aerosols that may be vented through the needle. 2 has an antimicrobial agent injection form 770 on the port 730 side.

[0051] FIG. 26 shows a collection port 830 adapted to receive a syringe 810 and a collection port 830 adapted to receive a culture bottle. 8 is a diagram of a disposable device 800 with a port 820. The neck 860 of the dispensing cannula 850 is shown in Figure 26. The dispensing cannula 850 passes through a needle insert 861. Antimicrobial foam 870 is disposed at the distal end of port 830, which receives the syringe. The extraction cannula is in fluid communication with a syringe 810. The syringe 810 is at subatmospheric pressure (i.e., (i.e., partial or full vacuum), thereby removing the sample from the culture bottle through the cannula 850. As the syringe 810 draws the aliquot from the culture bottle, the syringe 810 It is removed from the instrument 800 for processing.

[0052] FIG. 27A is a diagram of a disposable device 800 placed in a culture bottle 200, where The collection port 830 (illustrated as a needleless syringe with a Luer connector 911) A luer lock fitting 8 fluidly connects the collection device 910 to the contents of the culture bottle 200. 25. The disposable device has two needles, an insufflation needle 840 and a dispensing needle 850. Referring to FIG. 1B, cannula 850 provides a flow path from culture bottle 200 to collection device 910. The collection device 910 is connected to the cannula 850 and terminates in a luer lock 825. 3, the disposable device 80 is placed in communication with the sample holder 80 and a sample aliquot is aspirated. 0 / culture bottle 200 / collection tool assembly 910, cannula 850 for collection , and rotated so as to be in fluid communication with the contents of the culture bottle 200. Then, see FIG. 27C. The collection device 910 is then detached from the luer connector 825 of the disposable device 800. The collection device 910 is used to transport the collected sample for downstream processing.

[0053] As used herein, the term "comprising" means It has an "open" meaning, i.e., "including " and therefore has a "closed" meaning, i.e., "~ something that is limited in the sense of "consisting only of" The corresponding meaning is found in the corresponding word "comprise" , "comprised," and "comprises."

[0054] Although specific embodiments of the present technology have been described, the present technology may be modified in any manner without departing from its essential characteristics. It will be obvious to those skilled in the art that the present invention may be embodied in other specific forms. The described embodiments and examples are intended in all respects to be illustrative and not restrictive. must be considered not to be

[0055] Furthermore, references herein to known subject matter in the art of the invention are expressly incorporated by reference in their entirety. Unless otherwise stated, it is acknowledged that the subject matter is well known to those skilled in the art. It is understood as follows.

Claims

1. Multi-port disposable device for venting and dispensing aliquots from sealed sample devices - Patent Application 20070122999 The ingredients are At least a first port of the plurality of ports is configured to receive a top of a culture vessel. a proximal end open to receive the culture vessel, and a minor end of the plurality of ports a distal end terminating in a needle insert for at least the first port; 、 a second port of the plurality of ports configured to receive a sample collection container; a proximal end open to receive the sample collection container; and a distal end terminating in a needle insert that may be the same as or different from the needle insert for the first port; a second port of the plurality of ports having a disposed in at least one port of the plurality of ports of the multi-port disposable device a first needle extending from the needle insert and substantially penetrating the needle insert; a first needle having a cannula that does not extend into another port of the plurality of ports; a needle insert extending through the needle insert and received in the at least a first port of the plurality of ports; the culture vessel received in the second port of the plurality of ports; a second needle having a cannula providing fluid communication between the first proximal end and the vessel; a second distal end, the first proximal end adapted to pierce a septum or cap of the culture vessel; the second distal end is configured to pierce a septum or cap of the sample collection container. needles and 1. A multi-port disposable device comprising:

2. a first port and a second port, the multi-port disposable device further comprising: adjacent to the needle insert sandwiched between the first port and the second port.

10. The multi-port system of claim 1, further comprising a foam layer carrying a microbial agent disposed at a location adjacent the surface of the multi-port system. Disposable equipment.

3. a foam layer carrying the microbial agent disposed at the distal end of the second port; 3. The multi-port needle of claim 2, wherein the cannula of one needle terminates in the foam layer. Discarded equipment.

4. The needle insert extends from the distal end of the first port to the distal end of the second port. The multi-port disposable device of claim 2 , wherein the multi-port disposable device is held in the opening of the multi-port disposable device.

5. The plurality of ports includes the first port, the second port, and a third port. a third port configured to receive the top of the culture vessel; 10. The multi-port disposable device of claim 1.

6. The first needle is inserted into a second needle insert at the distal end of the third port of the plurality of ports.

6. The multi-port disposable device of claim 5, wherein the multi-port disposable device is held in a port.

7. 7. The method of claim 6, wherein a foam layer carrying a microbial agent is adjacent to the second needle insert.

1. The multi-port disposable device as described.

8. at least one of the first needle and the second needle has a sheath thereon.

2. The multi-port disposable device according to claim 1.

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

10. the second port is a connector adapted to connect to the sample collection container; The connector is in fluid communication with the second needle, and a proximal end of the connector is in fluid communication with the syringe. and a distal end of the connector is in fluid communication with a second needle. and equipment.

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

12. 10. The method of claim 9, wherein the second needle is carried by the syringe into the multi-port device. Multi-port disposable device.

13. The cannula of the second needle is inserted into the at least a first port of the plurality of ports.

12. The sample collection container according to claim 11, wherein the sample collection container extends from the connector.

10. The multi-port disposable device according to claim 1 .

14. Multi-port disposable device for venting and dispensing aliquots from sealed sample devices - Patent Application 20070122999 The ingredients are At least a first port of the plurality of ports is configured to receive a top of a culture vessel. a proximal end open to receive the culture vessel and a distal end terminating in a needle insert. a plurality of ports having an end; a second port of the plurality of ports configured to receive a sample collection container, a proximal end open to receive the sample collection container and terminating in the needle insert; a second port of the plurality of ports having a distal end including a first port; a needle insert disposed in at least one of the plurality of ports and extending from the needle insert; a first needle held in the needle insert, the first needle substantially penetrating the needle insert; a cannula that does not extend beyond the first port and does not enter the second port of the plurality of ports, a first needle configured to pierce a septum or cap of the container; a needle insert extending through the needle insert and received in the first port of the plurality of ports; a cannula providing fluid communication between the culture vessel and the first proximal end and a second distal end; a second needle having a first proximal end that pierces a septum or cap of the culture vessel; the second distal end is configured to pierce a septum or cap of the sample collection container. a second needle; 1. A multi-port disposable device comprising:

15. The first needle has a cannula, the cannula being connected to a first port of the plurality of ports. and the second port of the plurality of ports.

15. The multi-port disposable container of claim 14, wherein the container is terminated with a foam layer carrying a microbial agent. and equipment.

16. The foam layer carrying the microbial agent is disposed in the second port of the plurality of ports. the cannula of the first needle is disposed at the distal end of the needle and the follicular material carrying the microbial agent is inserted into the cannula.

16. The multi-port disposable device of claim 15, wherein the multi-port disposable device terminates in a rubber layer.

17. a second foam layer, the second foam layer contacting the second of the plurality of ports; 17. The plurality of needles according to claim 16, wherein the plurality of needles are disposed at the distal end of the port and adjacent the needle insert. Port disposable equipment.

18. between the first port of the plurality of ports and the second port of the plurality of ports 15. The needle insert of claim 14, further comprising a flange, said needle insert being secured to said flange. Multi-port disposable device.

19. at least one of the first needle and the second needle has a sheath thereon.

15. The multi-port disposable device according to 14.

20. 15. The method of claim 14, wherein the specimen collection container is a syringe and the second needle is a syringe needle. Multi-port disposable instruments.

21. Multi-port disposable device for venting and dispensing aliquots from sealed sample devices - Patent Application 20070122999 The ingredients are a first port of the plurality of ports configured to receive a top of a culture vessel; the first port having a proximal end open to receive the culture vessel; and a plurality of ports having a distal end terminating in a first needle insert; a second port of the plurality of ports configured to receive a sample collection container, a proximal end open to receive a collection container and terminating in said first needle insert; a second port of the plurality of ports having a distal end; a third port of the plurality of ports configured to receive a sample collection container, a proximal end open to receive a collection container and a distal end terminating in a second needle insert a third port of the plurality of ports having a disposed in the third port of the plurality of ports of the multi-port disposable device; a first needle retained in and extending from a second needle insert, the needle insert does not substantially penetrate the first port or the A cannula that does not enter the second port is provided to pierce the septum or cap of the culture vessel. a first needle configured to a needle extending through the first needle insert and received in the first port of the plurality of ports; a second needle having a cannula providing fluid communication between the first needle and the culture vessel; and a second distal end, the first proximal end being adapted to receive a septum or cap of the culture vessel. configured to pierce, the second distal end piercing a septum or cap of the collection container. a second needle configured to A multiple port disposable device comprising:

22. The first needle has a needle insert carrying a microbial agent disposed adjacent the second needle insert.

22. The multi-port disposable device of claim 21 having a cannula terminating in the foam layer.

23. a distal end of the first port of the plurality of ports and a distal end of the second port of the plurality of ports; and a flange between the first needle insert and the second needle insert, the flange being secured to the first needle insert.

22. The multi-port disposable device of claim 21.

24. at least one of the first needle and the second needle has a sheath thereon.

22. The multi-port disposable device according to 21.

25. Multi-port disposable device for venting and dispensing aliquots from sealed sample devices - Patent Application 20070122999 The ingredients are a first port of the plurality of ports configured to receive a top of a culture vessel; having a proximal end open to receive the container and a distal end terminating in a needle insert , multiple ports, a plurality of ports configured to couple to a sample collection container and including a fluid connector; a second port; and disposed in at least one port of the plurality of ports of the multi-port disposable device a first needle held in the needle insert and extending from the needle insert, The insert does not extend substantially through the insert and does not enter the second port of the plurality of ports. a cannula configured to pierce a septum or cap of the culture vessel; A first needle; The culture medium extends from the fluid connector and is received in the first port of the plurality of ports. a second needle having a cannula providing fluid communication between the first proximal end and the and a second distal end, the first proximal end adapted to pierce a septum or cap of the culture vessel. a second needle configured as follows:

1. A multi-port disposable device comprising:

26. The first needle is sandwiched between the first port of the plurality of ports and the fluid connector. and terminating in a foam layer carrying a microbial agent positioned adjacent to the needle insert.

26. The multi-port disposable device of claim 25, comprising a cannula.

27. The foam layer carrying the microbial agent is disposed at the distal end of the fluid connector, the cannula of the first needle terminates in the foam layer carrying the microbial agent.

27. A multi-port disposable device according to paragraph 26.

28. 28. The multiport disposable of claim 27, wherein the fluid connector is a luer connector. Ingredients.

29. between the distal end of the first port of the plurality of ports and the fluid connector, and 26. The compound of claim 25, further comprising a flange, the needle insert being secured to the flange. Multi-port disposable equipment.

30. at least one of the first needle and the second needle has a sheath thereon.

25. The multi-port disposable device according to 24.

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