EP1387710A2 - Dispositifs de transfert de fluide et leurs procedes d'utilisation - Google Patents

Dispositifs de transfert de fluide et leurs procedes d'utilisation

Info

Publication number
EP1387710A2
EP1387710A2 EP02734353A EP02734353A EP1387710A2 EP 1387710 A2 EP1387710 A2 EP 1387710A2 EP 02734353 A EP02734353 A EP 02734353A EP 02734353 A EP02734353 A EP 02734353A EP 1387710 A2 EP1387710 A2 EP 1387710A2
Authority
EP
European Patent Office
Prior art keywords
container
fluid
cap
closed system
shaped device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP02734353A
Other languages
German (de)
English (en)
Inventor
Rena Juliar
Guity Ettefagh
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nexell Therapeutics Inc
Original Assignee
Nexell Therapeutics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Nexell Therapeutics Inc filed Critical Nexell Therapeutics Inc
Publication of EP1387710A2 publication Critical patent/EP1387710A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5021—Test tubes specially adapted for centrifugation purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • A61M1/0209—Multiple bag systems for separating or storing blood components
    • A61M1/0231—Multiple bag systems for separating or storing blood components with gas separating means, e.g. air outlet through microporous membrane or gas bag
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082—Test tubes per se
    • B01L3/50825—Closing or opening means, corks, bungs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/60—Containers for suction drainage, adapted to be used with an external suction source
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0266—Shape memory materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/04—Access sites having pierceable self-sealing members
    • A61M39/045—Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/14—Tube connectors; Tube couplings for connecting tubes having sealed ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/165—Shrouds or protectors for aseptically enclosing the connector

Definitions

  • connection for the transfer of fluid between various components, along a fluid passageway and, eventually, either to a fluid container or to a patient.
  • connections include, but are not limited to, the processing of blood and its fractions, mixing of sterile solutions and connecting Foley catheters with urinary drainage bags.
  • these connections should be designed to be closed (i.e., without open exposure of the fluid pathway to air).
  • sterile disposable sets e.g., bags, tubing, etc.
  • One or more access points into sterile disposable sets are key to user convenience and system flexibility in closed system processing. All additions and removal of fluid (e.g., sampling, etc.) and connections of sets or other components for a next processing step are made via these access points.
  • Access points are typically terminal tubing connectors such as luer fittings, spike couplers and bag ports (e.g., spikable membrane ports).
  • Luer connectors are widely used in the medical industry for making a connection between medical devices to establish a fluid passageway.
  • a luer connection assembly includes a male luer tip component or fitting having a frustoconical shape that is inserted into a female luer component or fitting having a frustoconically shaped receiving cavity.
  • the opposing conical surfaces of the luer fittings come into contact and form a sealed friction fit assembly.
  • These connection assemblies and associated components are typically packaged in sterile packaging and include caps or protectors to maintain the sterility of the fluid pathway prior to use.
  • caps or protectors to maintain the sterility of the fluid pathway prior to use.
  • these connections must frequently be made inside a laminar flow hood to mitigate the fluid contamination risk.
  • a tubing set having a spike coupler as its terminal connector may be fluidly connected to a bag having a spikable membrane port.
  • a spike coupler assembly includes a spike component having a needle-like shape with a beveled tip that is inserted into a spikable membrane port generally having a cylindrically shaped receiving cavity or opening. The opposing surfaces of the spike coupler and membrane port come into contact and form a sealed friction fit assembly.
  • the spike coupler is used to access the contents of the bag through the membrane port. When the spike is inserted into the port, the membrane is broken causing the fluid to flow from the container through the spike and into the tubing set.
  • the lumen and/or passageway through the adapter that forms a portion of the fluid passageway be sterile prior to use and maintain sterility, such as by being sealed against microbial ingress, during connection and disconnection of the spike couplers.
  • Dead spaces or voids within the connector which cannot be "flushed” and in which stagnant fluid can collect to form a media for microbial growth should be minimized or eliminated. It is a related object of the present invention to provide a connector which forms a sealed fluid path such that a minimum number of microbes enter the fluid path during operation using aseptic techniques. Also, priming volume for the connector should be minimized.
  • rigid containers overcome these shortcomings typically associated with flexible bags, the use of rigid containers requires access to air. This is due to the fact that it is not possible to add or subtract fluids from such a container and maintain a constant volume inside the rigid closed container.
  • a volume of air is needed to compensate for removed/added fluids. For example, the removal of 200 ml of fluid results in the addition of an equal amount of air into the container and, thereby, into contact with the fluid path. As a result, the addition of air into the container potentially increases the risk of fluid and system contamination. Therefore, a connector or system that enables the addition and/or release of air/gases into a container without increasing the risk of fluid and system contamination and operator exposure is needed.
  • a fluid transfer device that includes a cap-shaped device including a first port and a second port.
  • the device may further include a filtration vent extending from the first port, wherein the filtration vent filters air passing through the filtration vent, and a tubing segment assembly extending from the second port and forming a passageway for fluid transfers.
  • the passageway formed by the device is a closed fluid pathway.
  • the device may be configured for attachment to a container, such as a rigid container, bottle, conical tube, centrifugation tube, centrifugation container, etc., or prefabricated onto a container and provided as an integral device.
  • the present invention may further include a method of transferring fluids into and out of a container comprising removing a cap form a container while under a laminar flow hood and installing a cap-shaped device onto the container.
  • the method may also include transferring the container to a general laboratory environment and connecting a closed system set to a tubing segment assembly of the cap-shaped device, whereby a fluid may be transferred into or out of said container in a closed system fluid pathway.
  • the method may further include transferring a fluid from the closed system set into the container, centrifuging the fluid and removing a portion of the fluid from the container.
  • the method may include pumping a fluid from a container through a second tubing segment of the cap-shaped device, through a tubing segment assembly and into a closed system set.
  • a further embodiment of the present invention may include a method of transferring fluids into or out of a container comprising addling a fluid to a container via a cap-shaped device of the container in a general laboratory environment, wherein a fluid pathway of the container and cap-shaped device is a closed system fluid pathway.
  • the method may also include centrifuging the fluid within the container and removing a portion of the fluid from the container while maintaining the closed system fluid pathway.
  • the method may further include connecting a receiving container to the closed system set, positioning the receiving container a sufficient distance below the container and aspirating fluid from the container to the receiving container.
  • Figure 1 is a perspective view of a dual port membrane adapter device in accordance with an embodiment of the present invention
  • Figure 2 is illustrates the assembly and internal components of the adapter device in accordance with an embodiment of the present invention
  • Figure 3 is an end view of the adapter device in accordance with an embodiment of the present invention.
  • Figure 4 is an end view of an alternate embodiment of the device of the present invention
  • Figure 5 is a sectional view of the adapter device in accordance with an embodiment of the present invention
  • Figure 6 illustrates a cap-shaped device in accordance with an embodiment of the present invention
  • Figure 7 is a perspective view of the cap-shaped device in accordance with an embodiment of the present invention.
  • Figure 8 is an alternate view of the cap-shaped device in accordance with an embodiment of the present invention.
  • Figure 9 illustrates an alternate embodiment of the cap-shaped device in accordance with the present invention
  • Figure 10 illustrates a method of using the adapter in accordance with an embodiment of the present invention
  • Figure 11 illustrates a method of using the cap-shaped device in accordance with an embodiment of the present invention.
  • an embodiment of a fluid transfer device in accordance with the present invention includes a connector or adapter 10 having a first cylindrically shaped conduit 12, a second cylindrically shaped conduit 14, and a hollow, cylindrically shaped sleeve 16 located between the first and second conduits 12,14 of the adapter 10.
  • Each conduit 12,14 and the sleeve 16 include a first end, a second end and a passageway extending therebetween for the passage of fluid.
  • the conduits 12,14 and sleeve 16 are aligned along the same longitudinal axis 13 and are configured in fluid flow relationship with each other.
  • the first end 18 of the first conduit 12 includes a fluid inlet port 20 and the second end 22 of the second conduit 14 includes a fluid outlet port 24.
  • the first end 18 of the first conduit 12 may include a fluid outlet port 20 and the second end 22 of the second conduit 14 may include a fluid inlet port 24.
  • the conduits 12,14 are configured for quick connection for releasably engaging a terminal end, such as a spike coupler, of a tubing set.
  • each conduit 12,14 is approximately 1.00 + 0.05 inch (25.40 + 1.27 mm) in length LC.
  • the tubular wall 26 forming the structure or framework of each conduit 12,14 may include a smooth internal surface 28, a smooth external surface 30 and a wall thickness TC.
  • the wall thickness TC, internal diameter IDC and external diameter EDC of each conduit are approximately within the range of 0.030 + 0.005 inch (0.762 + 0.127 mm), 0.190 ⁇ 0.005 inch (4.826 + 0.127 mm) and 0.250 + 0.005 inch (6.350 + 0.127 mm), respectively.
  • the diameters and wall thickness may either be uniform or variable along the longitudinal length of each conduit 12,14. A particular choice of wall thickness, diameters and length depends on the configuration of the mating terminal end intended for connection to the adapter 10. In other words, the configuration of each conduit 12,14 can vary according to the intended procedure, mating connection and usage.
  • the dimensional configuration of the sleeve 16 of the adapter 10 should be appropriately sized to surround and overlap portions of the conduits 12,14 and to provide a sufficient flow path for connecting devices (e.g., tubing set spike couplers).
  • the length LS of the device sleeve 16 may be approximately within the range of 1.50 ⁇ 0.05 inch (38.10 + 1.27 mm).
  • the overlap portions 32 of the conduits 12,14 and sleeve 16 may each be within the range of 0.25 ⁇ 0.05 inch (6.35 + 1.27 mm).
  • the tubular wall 34 forming the structure of the sleeve 16 may include a smooth internal surface 36, a smooth external surface 38 and a wall thickness TS.
  • the wall thickness TS, internal diameter IDS and external diameter EDS of the sleeve 16 are approximately within the range of 0.030 + 0.005 inch (0.762 + 0.127 mm), 0.245 + 0.005 inch (6.223 ⁇ 0.127 mm) and 0.305 ⁇ 0.005 inch (7.747 + 0.127 mm), respectively.
  • the diameters and wall thickness of the sleeve 16 may either be uniform or variable along the length of the sleeve.
  • the internal diameter IDS of at least a portion of the sleeve 16 should be appropriately sized to match at least a portion of the external diameter EDC of each conduit 12,14 to ensure that there is a snug and conforming fit and contact between the opposing external and internal surfaces 30,36 of each conduit 12,14 and sleeve 16, respectively. Further, the internal diameters of both the conduits 12,14 and sleeve 16 should be large enough to adequately support an unrestricted flow of fluid therethrough. Overall, the design of the adapter 10 should facilitate the connection of tubing lines that terminate in spike couplers.
  • the opposing external and internal surfaces 30,36 of each conduit 12,14 and sleeve 16, respectively may be textured to increase the surface area and, thereby, further enhance the contact characteristics of the surfaces of the friction fit assembly 10.
  • the opposing external and internal surfaces 30,36 of each conduit 12,14 and sleeve 16, respectively may be threaded for threaded engagement between the components of the adapter 10.
  • Alternative engagement features and configurations including, but not limited to, ridges, channels, grooves, bumps, indents, prongs, rods, tabs, flanges, chamfers, and threads are also included within the scope of the claimed invention.
  • the conduits 12,14 and sleeve 16 of the adapter 10 may be further secured together via ultrasonic welding. Additional techniques and methods used to secure together the components of the assembly 10 include, but are not limited to, frictional welding, chemical bonding, heat shrinking, and fusing. These and other techniques and methods not specifically disclosed herein but known to those skilled in the art are also included within the scope of the claimed invention.
  • the material characteristics of the adapter 10 are also important to achieve the desired performance features of the device 10. A variety of materials may be used to fabricate the adapter 10 of the present invention.
  • adapter materials include, but are not limited to, plastics (e.g., polyethylene, polyvinyl chloride, polycarbonate, etc.), silicone, stainless steel, metals, and ceramics, including combinations thereof.
  • the adapter materials should be sterilizable, biocompatible and non- pyrogenic.
  • the adapter 10 may be constructed as a rigid, flexible or semi-flexible connector, it is preferred that the materials together with the structural design of the adapter 10 provide sufficient strength and structural integrity to avoid kinking, collapse or restriction of the closed fluid flow path of the conduits 12,14 and sleeve 16.
  • the adapter 10 may be configured as single use, disposable connector.
  • the adapter 10 may be configured as a multiple use and re-sterilizable device.
  • each conduit 12,14 of the adapter 10 includes a transverse diaphragm or membrane 40 adapted for breakage by a spike coupler from a tubing set.
  • the membrane 40 may be located anywhere along the longitudinal length of the conduits 12,14 and, preferably, is located near the mid-section of each conduit 12,14. In one embodiment of the invention, the membrane 40 is located approximately within the range of + 0.125 inch (+ 3.1750 mm) from an end 42 of the sleeve 16 when the conduit 12,14 is housed within the sleeve 16.
  • the two membranes 40 of the adapter 10 form a closed chamber that extends along the length LS of the sleeve 16 and a portion 42 of the length LC of each conduit 12,14.
  • the membrane 40 is formed as a solid, resilient barrier capable of being pierced or broken when a terminal connector (e.g., spike coupler) is properly seated within the adapter 10.
  • the membrane 40 may include one or more slits 44 forming a valve-like element capable of being re-sealed in its closed configuration. For example, when a spike coupler penetrates the membrane 40, the slit(s) 44 spread apart and form an opening in the membrane 40 that substantially surrounds a portion of the spike coupler. The resulting connection between the spike coupler of the tubing set and the conduit 12,14 of the adapter 10 forms a closed fluid pathway, thereby minimizing, if not altogether eliminating, contamination risks.
  • each membrane 40 of the present invention may be fabricated from essentially the same materials of the conduits 12,14 and sleeve 16, as previously described.
  • the membranes 40, conduits 12,14 and/or sleeve 16 of the device 10 may be fabricated from dissimilar materials.
  • the membrane material is resilient and includes memory-characteristics that enable the membrane to return to its original configuration after use and adequately seal the fluid path of the system.
  • the adapter 10 of the present invention may include one or more covers or tip protectors 46 to shield the fluid inlet port and fluid outlet port of the conduits 12,14 from damage and contamination risks. These protectors maintain the sterility of the membrane portion of the connector during storage and up to the time of use.
  • a cap-shaped device in accordance with the present invention may include a sterile filtration vent 52 and a tubing segment assembly 54.
  • the cap-shaped device 50 includes a cylindrical neck 56 and a substantially planar surface 58 positioned perpendicular to the longitudinal axis 53 of the neck 56 and device 50.
  • the cap-shaped device 50 may be configured as a rigid or semi-flexible component.
  • the cylindrical neck 56 of the device 50 is configured for attachment to a bottle, conical tube, or other fixed volume fluid container.
  • alternate configurations of the neck 56 including, but not limited to, square-shaped, oval, and polygonal are known in the art and, as such, are also included within the scope of the claimed invention.
  • a sterile filtration vent 52 may extend from the first access port 60 and a tubing segment assembly 54 may extend from the second access port 60.
  • the sterile filtration vent 52 may include a sterile, tubular or luer-shaped element 62 having a filter (not shown) located within the interior cavity of the element 62. Before ambient air may enter or leave the system, it must first pass through the filer of the vent 52. As such, the sterile filtration vent 52 accomplishes several goals of the present invention.
  • the sterile filtration vent 52 maintains system sterility and reduces the probability of fluid and system contamination. In addition, since entrapped gases/air must also pass through the filter before leaving the system, user exposure to such potentially toxic and harmful gases/air is significantly reduced or completely eliminated by virtue of the vent 52. Further, with respect to fluid transfer operations using rigid containers, the sterile filtration vent 52 allows air and gases to enter/escape through the vent 52 and into/out of the closed rigid container to compensate for removed/added fluids, while maintaining sterility of the system via the filter.
  • the tubing segment assembly 54 of the device 50 of the present invention may include a segment of tubing 64 and a sterile tubular or luer-shaped element 66.
  • a first end 68 of the luer-shaped element 66 may extend from the second access port 60 of the device 50 and a second end 70 of the luer- shaped element 66 may be in communication with a first end 72 of the tubing segment 64.
  • Extending from the second end (not shown) of the tubing segment 64 may be a terminal end of another closed system sterile disposable set used to access to the contents of the container.
  • a second tubing segment 74 may also extend from the second access port 60 and/or first end 68 of the luer-shaped element 66 within the interior portion 76 of the cap-shaped device 50, as shown in Figure 8.
  • This second tubing segment 74 may be used as a straw or wick to access the contents of the container during use of the device 50, as further described below.
  • the length of the second tubing segment may vary.
  • the tube 74 may extend to the bottom of the bottle and be configured with a beveled or other similar non-blunt end. This design would facilitate removal of the contents by pumping when the container is in an upright position.
  • the second tubing segment 74 may extend to varying levels or depths towards the conical bottom. In essence, the level or lengths of the second tubing segment 74 dictates the lowest level of fluid which may be aspirated from a container.
  • the second tubing segment 74 may extend through the second access port 60 of the device 50 (not shown).
  • the second tubing segment 74 may be mated to the cap 50 in such a way as to enable a hermetic seal while allowing for user manipulation of tubing depth within the container to thereby access a variety of fluid levels.
  • the connector or cap-shaped device 50 of the present invention may be fabricated from a variety of materials, such as those previously described herein.
  • the device materials should be sterilizable, biocompatible and non-pyrogenic. Together with the materials, the particular dimensional characteristics of the device 50 should be optimized to achieve the desired performance features of the device 50, such as desired fluid flow rates and sufficient venting.
  • the vent 52 may be configured to include an adequate flow-through and filtration area to enable free fluid flow from the tube 54.
  • the tubing segments 64,74 may be configured as flexible, semi-flexible or rigid components, depending upon the desired performance characteristics of the device 50.
  • the device 50 should be configured to allow fluid transfers and processing to be conducted in the open laboratory environment, without the risk of contaminating the reagents and cellular products and exposing technicians to contamination during the procedure.
  • the cap-shaped device 50 may be supplied to users in several conventional container (e.g., bottle, bag, tube, etc.) bottle sizes to accommodate a variety of bottled reagents.
  • the cap 50 may be pre-fabricated onto a container and provided as an integral device.
  • Figure 9 depicts an example of what this embodiment of a capped-container device 78 may look like in accordance with the present invention.
  • the device 78 includes the cap-shaped device 50 and a container 79.
  • the container 79 depicted in Figure 9 is a conical tube, any of a variety of containers including, but not limited to, bottles and bags may be used and are also included within the scope of the claimed invention.
  • this container 79 may be supplied in an unfilled or empty state to enable user addition/subtraction of fluid.
  • the cap-shaped device 50 may be either permanently or removably attached to the container 79.
  • the container 79 may be supplied pre-filled with a solution, reagent or other desired fluid to bypass the need for cap placement entirely. Similar to the previous embodiment, the pre-filled cap-shaped device 50 may be either permanently or removably attached to the container 79.
  • the double membrane port adapter 10 may be used in closed system cellular processing.
  • one step of a typical cellular processing procedure may require two single use sterile disposable sets (e.g., tubing sets terminating in spike couplers) to be joined together for a fluid transfer operation.
  • a spike coupler 80 of a first tubing set is inserted along the longitudinal axis of the adapter 10, through a port 20 and into a first conduit 12 of the device 10.
  • the spike coupler 80 is then advanced further within the conduit 12 until at least the tip 82 of the spike coupler penetrates through the membrane 40 of the conduit 12 and the spike coupler 80 is properly seated within the adapter 10.
  • the fluid pathway of the first tubing set remains in a closed, sealed configuration due to the unbroken membrane 40 of the second conduit 14 of the adapter 10.
  • a spike coupler 84 of a second tubing set is inserted along the longitudinal axis of the adapter, through a port 24 and into a second conduit 14 of the device 10.
  • the spike coupler 84 is then advanced further within the conduit 14 until at least the tip 86 of the spike coupler 84 penetrates through the membrane 40 of the conduit 14 and the spike coupler 84 is properly seated within the adapter 10 (not shown).
  • Penetration of the second spike coupler 84 through the membrane 40 of the second conduit 14 creates a closed, continuous, aseptic fluid pathway and, thereby, enables fluid to be transferred via the sets.
  • Closed system cellular processing methods may also require the transfer of fluid into or out of containers.
  • a cap-shaped device 50 may be used to provide added convenience for the user and processing flexibility.
  • a user of the device 50 would replace the manufacturer provided cap on a container with the cap-shaped device 50 of the present invention while under a laminar flow hood.
  • the capped container 88 could then be removed to the general laboratory environment, where all fluid transfers of the processing procedure may be performed while using the device 50.
  • the tubing segment 64 on the cap-shaped device 50 could be connected to other closed system sterile disposable sets 90.
  • fluid could then be transferred from the bottle 88 to the closed system sterile disposable set 90 through the tubing segment 64 via gravity by inversion of the bottle 88.
  • a volume of ambient air will enter the container/bottle 88 via the sterile filtration vent 52 to replace the lost volume of fluid during the fluid transfer operation.
  • the tubing segment assembly 54 forms a closed system fluid pathway, together with the filtration vent 52, for maintaining the sterility of the system.
  • the fluid may be pumped out of the bottle 88, through the tubing segment 64 and into the disposable set 90.
  • the cap-shaped device 50 may be configured with a second tubing segment 74 inside the bottle. As a result, the bottle 88 could remain in an upright position and the fluid could be pumped out of the bottle 88 via the second tubing segment 74, through the tubing segment 64 and into the disposable set 90.
  • the processing procedure may be carried out using the cap-shaped device 50 configured onto a conical shaped tube/container 79, as shown in Figure 9.
  • a cell suspension may be added to the container 79 by connecting the tubing segment 64 to another closed sterile set.
  • the device 78 would be sealed (reversibly or irreversibly) and the whole apparatus 78 placed into a centrifuge.
  • the apparatus 78 would be centrifuged resulting in pelletization of the heavier cells or other particles from the fluid.
  • the apparatus 78 would be removed from the centrifuge and another connection would be made to the tubing segment 64, typically via an alternate distal connector.
  • the fluid portion of the suspension may then be aspirated via the second tubing segment 74 into a closed receiving container (not shown) via gravity and capillary action.
  • This process of aspirating the fluid from the container 79 may be accomplished by placing the receiving container a sufficient distance below the conical shaped tube 79 to draw off the fluid. Residual fluid in the bottom of the container 79 may be aspirated by slightly tipping the container 79 and without disturbing the cell pellet.
  • the length of the second tubing segment 74 may be configured as desired to remain near the level of a cell pellet, yet not allow cells to become lodged there during centrifugation. It is clear that the tubing length might be longer to accommodate tubes of greater length. In additional embodiments of the invention, caps 50 (or full assemblies 78) may be made with different tubing lengths. As such, the user would simply decide which embodiment to use based on the chosen application.
  • the cap-shaped device 50,78 of the present invention facilitates the addition of the bottled reagent or fluid to closed sets and, thereby, reduces overall costs of processing procedures.
  • the device 50,78 enables processing in an open laboratory environment by providing a closed system fluid path that reduces the risk of contamination to the reagents and cellular products and increases user or technician safety during processing procedures.
  • the device 50,78 reduces the potential of exposure of the operator to potentially biohazardous materials.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Clinical Laboratory Science (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Animal Behavior & Ethology (AREA)
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Abstract

L'invention concerne un dispositif et un procédé d'utilisation permettant de faciliter les transferts de fluide lors de procédures de traitement de systèmes fermés stériles. Le dispositif est configuré pour créer des connexions pour permettre le transfert d'un fluide entre des composants variés, le long d'un passage de fluide stérile fermé, et soit jusqu'à un contenant de fluide, soit jusqu'à un patient. Par conséquent, le dispositif et le procédé d'utilisation de l'invention permettent de réduire le risque de contamination avec les fluides, tels que les réactifs, les médicaments et les produits cellulaires. L'invention permet également d'augmenter la sécurité au niveau d'un utilisateur ou d'un technicien lors de procédures de traitement.
EP02734353A 2001-05-08 2002-05-07 Dispositifs de transfert de fluide et leurs procedes d'utilisation Withdrawn EP1387710A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US28942901P 2001-05-08 2001-05-08
US289429P 2001-05-08
PCT/US2002/014849 WO2002089725A2 (fr) 2001-05-08 2002-05-07 Dispositifs de transfert de fluide et leurs procedes d'utilisation

Publications (1)

Publication Number Publication Date
EP1387710A2 true EP1387710A2 (fr) 2004-02-11

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EP02734353A Withdrawn EP1387710A2 (fr) 2001-05-08 2002-05-07 Dispositifs de transfert de fluide et leurs procedes d'utilisation

Country Status (4)

Country Link
US (1) US20020185186A1 (fr)
EP (1) EP1387710A2 (fr)
AU (1) AU2002305527A1 (fr)
WO (1) WO2002089725A2 (fr)

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Also Published As

Publication number Publication date
WO2002089725A8 (fr) 2004-05-21
WO2002089725A2 (fr) 2002-11-14
WO2002089725A3 (fr) 2003-11-27
US20020185186A1 (en) 2002-12-12
AU2002305527A1 (en) 2002-11-18

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