US20140238950A1 - Container connector - Google Patents

Container connector Download PDF

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Publication number
US20140238950A1
US20140238950A1 US14/348,114 US201214348114A US2014238950A1 US 20140238950 A1 US20140238950 A1 US 20140238950A1 US 201214348114 A US201214348114 A US 201214348114A US 2014238950 A1 US2014238950 A1 US 2014238950A1
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United States
Prior art keywords
end
vent
septum
needle
defining
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Abandoned
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US14/348,114
Inventor
Alexander Jackson
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GE Healthcare Ltd
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GE Healthcare Ltd
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Publication date
Priority to US201161541422P priority Critical
Application filed by GE Healthcare Ltd filed Critical GE Healthcare Ltd
Priority to PCT/US2012/058282 priority patent/WO2013049806A1/en
Priority to US14/348,114 priority patent/US20140238950A1/en
Assigned to GE HEALTHCARE LIMITED reassignment GE HEALTHCARE LIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: JACKSON, ALEXANDER
Publication of US20140238950A1 publication Critical patent/US20140238950A1/en
Application status is Abandoned legal-status Critical

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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00Closures not otherwise provided for
    • B65D51/002Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/52Containers specially adapted for storing or dispensing a reagent
    • B01L3/523Containers specially adapted for storing or dispensing a reagent with means for closing or opening
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00Closures not otherwise provided for
    • B65D51/16Closures not otherwise provided for with means for venting air or gas
    • B65D51/1672Closures not otherwise provided for with means for venting air or gas whereby venting occurs by manual actuation of the closure or other element
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00Closures not otherwise provided for
    • B65D51/18Arrangements of closures with protective outer cap-like covers or of two or more co-operating closures
    • B65D51/20Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing
    • B65D51/22Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure
    • B65D51/221Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure a major part of the inner closure being left inside the container after the opening
    • B65D51/222Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure a major part of the inner closure being left inside the container after the opening the piercing or cutting means being integral with, or fixedly attached to, the outer closure
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00Closures not otherwise provided for
    • B65D51/18Arrangements of closures with protective outer cap-like covers or of two or more co-operating closures
    • B65D51/20Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing
    • B65D51/22Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure
    • B65D51/221Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure a major part of the inner closure being left inside the container after the opening
    • B65D51/222Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure a major part of the inner closure being left inside the container after the opening the piercing or cutting means being integral with, or fixedly attached to, the outer closure
    • B65D51/225Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure a major part of the inner closure being left inside the container after the opening the piercing or cutting means being integral with, or fixedly attached to, the outer closure and further comprising a device first inhibiting displacement of the outer closure
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/044Connecting closures to device or container pierceable, e.g. films, membranes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/046Function or devices integrated in the closure
    • B01L2300/048Function or devices integrated in the closure enabling gas exchange, e.g. vents
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/06Auxiliary integrated devices, integrated components
    • B01L2300/0672Integrated piercing tool
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/06Valves, specific forms thereof
    • B01L2400/0677Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
    • B01L2400/0683Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers mechanically breaking a wall or membrane within a channel or chamber

Abstract

A connector cap for a reagent bottle which can be pre-attached to a fully assembled synthesis cassette allows greater control in the assembly of the cassette and simpler operation for the end user. The connector cap may be incorporated onto reagent bottle or on vials to be used with automated synthesis cassettes.

Description

    FIELD OF THE INVENTION
  • The present invention is relates to the field of fluid connectors. More specifically, the present invention is directed to a container connector which may be employed in automated chemistry systems
  • BACKGROUND OF THE INVENTION
  • Radiotracer synthesis has benefited from increased reliance on automated synthesizers and synthesis cassettes. Synthesis cassettes may be manufactured in a controlled environment and is shipped pre-assembled. For the end user this makes meeting GMP requirements simpler and radiotracer production more reliable than for platforms for which the cassette and reagents are supplied separately and are assembled by the end user. In this respect, minimizing the required number and complexity of connections made to the cassette prior to synthesis is desirable.
  • The FASTlab® system, sold by GE Healthcare of Liege, Belgium, is a synthesizer/cassette system which is able to perform multi-step radiochemistry and on-cassette cartridge based purification. Such processes may fully utilize the capacity of the FASTlab cassette and require additional reagent bottles to be connected thereto, especially for cartridge based purification where greater volumes of solvent are needed than can fit into the cassette casing. This has led to the use of additional reagent bottles that are connected to the cassette by piercing the bottle stopper with large diameter needles. Once the bottles stoppers are pierced by the needles, the reagent is available for use. It is not desirable to have the stoppers pre-pierced prior to shipping of a commercial cassette since the reagent is then not confined to the regent bottle and may contaminate the cassette or deform the bottle septum such that fluid integrity is lost. This prohibits shipping a fully assembled cassette and means that there must be some final assembly by the end user. The needle tops and tubing connections can be color-coded to simplify assembly by the end user but there is still potential for operator error which could lead to failed production. One such user error could be failing to push a needle into the bottom of the reagent bottle which would make the reagent inaccessible. Also, the use of needles results in the risk of stab injuries.
  • There is therefore a need for a means for connecting a conduit to a container in a manner that allows both to be shipped in an inactivated condition, that is, mechanically connected without establishing fluid communication therebetween, so as to then be placed in an activated condition the conduit and the container in fluid communication.
  • SUMMARY OF THE INVENTION
  • In view of the needs of the art, the present invention provides a connector cap for a reagent bottle which can be pre-attached to either a partially-assembled or a fully-assembled synthesis cassette. This will allow greater control in the assembly of the cassette and simpler operation for the end user. This type of reagent bottle should be particularly suited to delivery of volumes of solvent for on-cassette cartridge-based purification of radiotracers.
  • In an exemplary embodiment, the present invention provides a container connector for a container having an annular neck defining a container aperture and a pierceable septum spanning the container aperture. The container connector includes a connector cap and a septum piercing unit. The connector cap includes an annular cap body having opposed first and second ends and an elongate annular wall extending therebetween. The first end defines a first aperture, the annular wall includes an annular interior surface defining a cap cavity in fluid communication with the first aperture, and the interior surface is sized and shaped sized to engage the annular neck so that the cap can be moved from a first position with respect to the neck to a second position with respect to the neck. The septum piercing unit includes an elongate unit body including longitudinally opposed transversely-extending first and second end surfaces. The first and second end surfaces support a first cannula extending therefrom. The first cannula and unit body define a first and second fluid port respectively, wherein the first cannula and unit body further defines an elongate fluid passageway extending in fluid communication between the first and second fluid ports. The unit body is sized to span the container aperture such that the unit body is urgeable by the cap from the first position wherein the second cannula is positioned in overlying registry with the septum, to the second position wherein the second cannula has pierced the septum.
  • The reagent bottle can be pre-filled and attached to the cassette and is ‘activated’ by a simple operation by the end user prior to use. This should lead to fewer production failures due to incorrectly connected reagent bottles and safer operation due to reduced usage of sharp needles.
  • The connector cap may also be mated to bottles or vials providing sources of other fluids, or to a bottle or vial used for product collection or dispensing.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 depicts an exploded view of a bottle incorporating a container connector of the present invention.
  • FIG. 2 depicts a cap and septum-piercing unit of the present invention.
  • FIG. 3 depicts a cross-sectional view of the container connector in a first position, before ‘activation’
  • FIG. 4 depicts a cross-sectional view of the container connector in a second position, after ‘activation’
  • FIG. 5 depicts an automated synthesis cassette incorporating a container connector of the present invention between the cassette and a reagent container.
  • FIG. 6 depicts a support member which may be employed with a container connector of the present invention.
  • DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
  • The present invention provides a connector cap for allowing quick connection between a conduit and a container. The present invention also provides a container, such as a bottle or vial, configured to engage or incorporate the connector cap of the present invention. The connector cap of the present invention allows:
    • i) additional reagent to be used with a fully pre-assembled automated synthesis cassette;
    • ii) simplified operation by the end user with reduced chances of production failure;
    • iii) maintaining integrity of a reagent container until ‘activation’ before use;
    • iv) connection to be made without exposing the operator to sharp needles; and
    • v) other applications where connection between a container and a fluid conduit are required, including, e.g., source vials and or product collection vials.
  • The bottle body has a threaded top and a septum which keeps the reagent contained within the cavity until ‘activation’. The septum piercing unit is pushed downwards by the action of tightening the cap. The cap has an open top to allow access to the fittings on the septum piercing unit. The septum is pierced by the two spikes (or needles or cannulas, etc.) on the septum piercing unit. This constitutes ‘activation’. Before activation the reagent is sealed with the bottle cavity. After activation the reagent is accessible and may be provided through the septum piercing unit to, e.g., a FASTlab cassette. The bottle includes dip tube which makes sealing connection with fluid cannula, or needle, of the piercing unit so as to effect deeper penetration of the fluid cannula into the bottle cavity.
  • Desirably, the piercing unit and the bottle cooperatively engage each other so as to prevent rotation of the piercing unit by the rotation of the cap. Additionally, the dip tube may be fluted at one end to allow for some rotational displacement of the fluid cannula, the septum being contemplated to assist in the fluid-tight connection between the cannula and dip tube.
  • Similarly, the piercing unit provides a vent cannula which pierces the septum to thus allow for airflow into the bottle cavity and assist in evacuation of the reagent through the fluid cannula. The bottle may include a vent tube which, like the dip tube for the fluid cannula, provides sealed engagement with the vent cannula. The present invention further contemplates that both the dip tube and the vent tube may depend from a planar substrate supported below the septum in the bottle.
  • The reagent bottle might be constructed mainly from polypropylene which would have compatibility with water/organic mixtures. Other materials could be considered. Glass is also a possible material for the main bottle body.
  • Referring now to FIG. 1, an exploded view of a reagent bottle 5 defining an open container cavity 6 employing a container connector 10 of the present invention is shown. Container connector 10 includes a connector cap 12 and a septum piercing unit 14 which cooperatively engage bottle 5. Bottle 5 includes an annular neck 16 supporting a pierceable elastomeric septum 18 spanning across an open container aperture 20 defined by neck 16. Septum is desirably formed from an elastomeric material which may be pierced by either a needle or cannula but will self-seal up removal of the needle or cannula for applications requiring the contents within cavity 6 to remain after removal of the needle or cannula. Bottle 5 includes a concave bottom 9 facing cavity 6 so as to provide a ‘low point’ within cavity 6 in which fluid will collect when bottle 5 is upright.
  • With additional reference to FIGS. 2-4, connector cap 12 includes an annular cap body 22 having opposed first and second ends 24 and 26 and an elongate annular wall 28 extending therebetween. First end 24 includes an inwardly-extending annular rim 25 which defines a first aperture 30. Annular wall 28 includes an annular interior surface 32 defining a cap cavity 34 in fluid communication with first aperture 30. Interior surface 32 is sized and shaped sized to engage the annular neck 16 so that the cap can be moved from a first position with respect to the neck to a second position with respect to the neck. Septum piercing unit 14 includes an elongate unit body 40 including longitudinally opposed transversely-extending first and second end surfaces 42 and 44. The first and second end surfaces 42 and 44 support first cannula 46 extending therefrom. First cannula 46 and unit body 40 define a first and second fluid port, 50 and 52, respectively and an elongate fluid passageway 54 extending in fluid communication between first and second fluid ports 50 and 52. Unit body 40 is sized to span container aperture 20 so that second end surface 44 is engaged by rim 25 such that unit body 40 is urgeable by cap 12 from the first position, depicted in FIG. 3, wherein the first cannula 46 is positioned in overlying registry with septum 18, to the second position, depicted in FIG. 4, wherein second cannula 46 has pierced septum 18.
  • Unit body 40 of said septum piercing unit 14 may be configured to include opposing first and second major surfaces 54 and 56, respectively, which extend in facing opposition to interior surface 32 as container connector 10 is assembled. Septum piercing unit 14 may further include an elongate hollow needle 60 extending through unit body 40 thereof, where needle 60 includes a first end 62, a second end 64, and an elongate tubular body 66 extending therebetween. First end 62 defines a first needle aperture 68, second end 64 defines a second needle aperture 70, and tubular body 66 defines an elongate needle passageway 72 extending in fluid communication therebetween, such that said first end 62 of needle 60 is first cannula 46 which pierces septum 18. Second end 64 of needle 60 supports a connector 74 thereon, such as a female luer connector. As depicted in the example shown in FIG. 5, connector 74 engages a mating connector at one end of an elongate conduit 75 having an elongate tubular body defining an open conduit passageway therethrough. Connector 74 is thus able to place the conduit passageway in fluid communication with needle passageway 72. The present invention contemplates that conduit 75 may be connected to a synthesis cassette 100 as shown in FIG. 5, or to any source of a fluid to deliver to container 5.
  • While first cannula 46 is depicted as being the first end 62 of needle 60, the present invention further contemplates that cannula 46 may be formed from as a unitary member with unit body 40. Additionally, first cannula 46 may have either a sharp or blunt first end for piercing septum 18. It is known that blunt cannulas may be designed to pierce septums. As some embodiments of the present invention will not be concerned with the integrity of septum 18 after fluid withdrawal from cavity 6, it will be apparent to those of ordinary skill in the art how to thus select the design of cannula 46 for the particular application.
  • The present invention further contemplates that container connector 10 further includes an elongate second cannula 48 projecting from unit body 40. Second cannula 48 provides for piercing septum 18 for venting. In the embodiment shown in FIG. 1-4, a vent needle 80 extending through unit body 40 provides both the second cannula 48 as well as the vent passageway through unit body 40. Vent needle 80 includes a first end 82, a second end 84, and an elongate tubular vent body 86 extending therebetween. First end 82 defines a first vent aperture 88, second end 84 defines a second vent aperture 90, and tubular body 86 defines an elongate vent passageway 92 extending in fluid communication therebetween. The present invention contemplates that vent needle 80 provides the second cannula 48. Desirably, vent body 86 supports a porous filtration media 94 across second aperture 90. Media 94 defines porous passageways 96 therethrough in fluid communication with vent passageway 92 so as to limit the passage of contaminants therethrough but still allows air to vent therethrough from container 5. As unit body 40 is urgeable by cap 12 from the first position wherein the second cannula 48 is positioned in overlying registry with septum 18, to the second position wherein second cannula 48 has pierced septum 18. The present invention further contemplates that filtration media 94 may be supported within any housing such that the filter passageways 96 are in sealed fluid communication with vent passageway 92. For example, as shown in FIG. 5, vent needle 80 may include provide a media housing 81 suspended above cap 12 such that vent body 86 includes bend to accommodate the particular geometry of housing 81 about other components or connections of container connector 10.
  • The present invention contemplates that cap 12 and neck 16 include mating helical threads 13 and 17, respectively, which guide movement of the cap between the first and second positions. Desirably, cap 12 and neck 16 further include cooperating detents for resisting movement of cap 12 from the first position. Additionally, cap 12 and neck 16 desirably include cooperating detents for resisting movement of cap 16 from the second position.
  • Additionally still, septum piercing unit 14 engages neck 16 so as to prevent rotation of the septum piercing unit along its axis of travel as cap 16 is moved from the first to the second position. Towards this goal, that neck 16 may provide opposing guide slots 21 and 23 into which opposing edges 41 and 43 of planar unit body 40 are received so as to allow the linear displacement towards septum 18, although any mating engagement between unit body 40 and neck 16 will be configured to allow such linear displacement. For example, should unit body 40 have substantially cylindrical shape, neck 16 could support one or more inwardly-extending rails which are received in corresponding grooves formed in unit body 40.
  • The present invention further contemplates providing an elongate tubular dip tube 102 supported in bottle cavity 6 for use with container connector 10. Dip tube 102 includes a first end 104, an opposed second end 106, and an elongate tubular dip tube body 108 extending therebetween. First end 104 defines a first dip tube aperture 110, second end of dip tube 102 defines a second dip tube aperture 112, and dip tube body 108 defines an elongate dip tube passageway 114 extending in fluid communication therebetween. Desirably, second end 106 of dip tube 102 is positioned adjacent septum 18 in underlying registry with the first end 62 of needle 60. First end 104 of dip tube 102 extends towards the bottom of cavity 6, desirably centered above the concave bottom 9. The present invention contemplates that when cap 12 is moved to the second position, first end 62 of needle 60 will be in fluid-tight engagement with first end 104 of dip tube 102, as that portion of septum 18 about needle 60 will be compressed therebetween, while still placing dip tube passageway 114 in fluid communication with needle passageway 72. In one embodiment of the present invention shown in FIG. 6, a dip tube support member 120 positions second end 106 of dip tube 102 adjacent to septum 18. Dip tube support member 120 spans container aperture 20, and is desirably held in place between an annular container shoulder 7 and septum 18. Support member 120 includes an outer annular ring 122 with a segment 124 extending to support second end 106 of dip tube 102. Annular ring 122 is sized and shaped to rest on an annular shoulder 7 of container 5. Septum 18 sealingly engages interior surface 32 while adjacent to or on rim 122 Support member 120 may be designed so as to hold second end 106 of dip tube either abutting against septum 18 or slightly spaced thereabove. As the tip of needle 60 is pushed through septum 18 into dip tube 102, the material of septum 18 can serve as a gasket between needle 60 and dip tube 102 so as to ensure fluid from to or from needle 60 all passes out of or in through dip tube 102 at aperture 110. The present invention further contemplates that annular ring 122 of support member 120 may take other shapes such as substantially planar or substantially conical where the second end 106 of dip tube 120 opens therethrough.
  • Moreover, the present invention contemplates alternatively providing an elongate tubular vent tube 130 supported by support member 120 in bottle cavity 6. Vent tube 130 including a first end 132, an opposed second end 134, and an elongate tubular vent tube body 136 extending therebetween. First end 132 defines a first vent tube aperture 138, second end 134 defines a second vent tube aperture 140 and vent tube body 136 defines an elongate vent tube passageway 142 extending in fluid communication therebetween. As second end 134 is positioned adjacent septum 18 in underlying registry with first end 82 of vent needle 80, vent tube 130 is able to receive the first end of vent needle 80 as it is inserted through septum 18 upon movement of cap 12 to the second position. In the second position, passageway 92 is placed in fluid communication with vent tube passageway 142. Fluid delivered through needle 60 into cavity 6 will cause the gas within cavity 6 to be pushed out through vent needle passageway 92. Similarly, as fluid is withdrawn from cavity 6 through dip tube 102 and needle 60, gas may be reintroduced into cavity 6 through vent tube passageway 142.
  • As described, the provision of dip tube 102 and vent tube 130 allows for a fluid to be delivered into cavity 6 without requiring deep penetration of needle 60 or vent needle 80 through septum 18. Additionally, if needle 60 and dip tube 102 sealingly-engage each other as described, the contents of cavity 6 may also be withdrawn therefrom. The present invention thus provides for a container to which fluid may be delivered and withdrawn, providing for the possibility of mixing a fluid to the contents of the container, such as a reagent provided within cavity 6, so that the mixture may be withdrawn from the container.
  • The present invention further contemplates that both the dip tube and the vent tube may be supported below the septum in the bottle. With additional reference to FIG. 6, support member 120 may then include segment 126 inwardly extending from rim 122 to second end 134 of vent tube 130. Again, it may be desirable to provide some clearance between second aperture 140 and septum 18 so as to allow some deflection of septum 18 towards the first openings of the dip tube and vent tube as the cannulas are urged through the septum.
  • As shown in FIG. 1, the present invention may alternatively include a removable key 200 which prevents unintended movement of cap 12 and septum piercing unit 14. Key 200 includes opposed deflecting tangs 201 and 202 which define a neck receptacle 204 therebetween. Key 200 includes a grip 205 for ease of pulling key 200 laterally away from neck 16. Key 200 may be positioned such that neck 16 is received in neck receptacle 204 with tangs 201 and 202 extending between cap 12 and bottle 5. Tangs 201 and 202 prevent cap 12 from being tightened down on neck 16 until key 200 is removed from about neck 16. Key 200 thus prevents unintended movement of cap 12 which could pre-maturely pierce septum 18.
  • Further enhancements to the design could include the provision of some kind of rip off tab which would prevent accidental activation prior to use. This could be similar in design to those seen commonly on food containers. There could also be some kind of locking mechanism whereby once the bottle has been activated, it cannot be un-activated. This could be similar in operation to the mechanism commonly used on medicine bottles.
  • Referring now to FIG. 5, the present invention also contemplates providing a synthesis cassette 100 incorporating the container connector 10 of the present invention. Cassette 100 is a version of a FASTlab synthesis cassette, although the present invention contemplates that the present invention can be applied to the cassettes for other synthesizers. Cassette 100 includes an elongate manifold 302 which incorporates a number of actuation valves 301-325 which are connected to either an activity inlet reservoir 330, syringe pumps 332, 334, 336, cartridges 340, 342, conduits 350 and 352 leading to a reaction chamber 326, or conduits 354 and 356 leading to cartridges 340 and 342 respectively. Valves 308, 309, 317 and 320 are capped so as to provide connection to nothing. Manifold 300 is further connectable to a waste vial (not shown), a dispense vial (not shown), as well as to internal reagent vials (at valves 302, 312-314 and 316, not shown). The actual design of cassette 100 is not essential to the present invention, so long as it provides most or all of the fluid path used for the synthesis of a product fluid, such as a radiotracer for PET or SPECT imaging and so long as it provides for connection to a container connector 10 of the present invention. An active isotope is provided to an inlet reservoir at valve 306 and operation of the cassette may then direct it through a synthesis procedure. Valve 315 is connected to a source 360 of water for injection. Manifold 300 further provides ports for connection to a pneumatic system to further provide a motive force through manifold 300.
  • Using container connector 10, the cassette 100 may be shipped connected to an external reagent bottle 5 having a neck 16, as described hereinabove, which cooperatively engages the cap 12 of connector 10 and the septum piercing unit 14. The present provides that cassette 100 may be shipped with the connections made between reagent bottle 5 and cassette 100 with connector cap 12 in the first, inactivated, position. Key 200 is provided about neck 16 so as to prevent cap 12 from inadvertently causing unit body 40 from piercing septum 18. Alternatively, the present invention provides a kit of parts including a cassette 100 and reagent vial 5 adapted to be connected to cassette 100 by connector cap 10 and conduit 75. The kit of parts may be shipped in a sterile package, such as a plastic bag, allowing the kit components to be loaded into the sterile package in environmentally clean conditions where the container is then sealed so as to maintain the clean or sterile condition experienced by the kit components until the package is opened. It is contemplated that the package is opened in a clean environment so that the kit components may be assembled and put to use without requiring further sterilization. Cassette 100 when assembled, may then be connected to an automated synthesizer, in the present illustration a FASTlab synthesizer, as well as connected to a waste vial, a dispense vial, and optionally to an HPLC purification system (shown at valves 318 and 319). Cassette 100 may thus be operated to include a reagent included within vial 5 in the synthesis process it performs. The actual synthesis process is not considered essential to the instant invention, just the provision of an external reagent bottle 5 which may be connected to manifold 300 either a time just prior to synthesis or even just prior to packaging.
  • While the particular embodiment of the present invention has been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from the teachings of the invention. The matter set forth in the foregoing description and accompanying drawings is offered by way of illustration only and not as a limitation. The actual scope of the invention is intended to be defined in the following claims when viewed in their proper perspective based on the prior art.

Claims (19)

What is claimed is:
1. A container connector for a container having an annular neck defining a container aperture and a pierceable septum spanning the container aperture, said container connector comprising:
a connector cap comprising an annular cap body having opposed first and second ends and an elongate annular wall extending therebetween, the first end defining a first aperture, the annular wall including an annular interior surface defining a cap cavity in fluid communication with the first aperture, the interior surface sized and shaped sized to engage the annular neck so that the cap can be moved from a first position with respect to the neck to a second position with respect to the neck; and
a septum piercing unit comprising an elongate unit body including longitudinally opposed transversely-extending first and second end surfaces, said unit body supports a first cannula, respectively, extending therefrom, said first cannula and said unit body defining a first and second fluid port respectively, wherein said unit body and said first cannula further define an elongate fluid passageway extending in fluid communication between said first and second fluid ports;
wherein said unit body is sized to span said container aperture such that said unit body is urgeable from said first position wherein said second cannula is positioned in overlying registry with the septum, to said second position wherein said second cannula has pierced the septum, said unit body being urgeable between said first and second position by said cap.
2. A container connector of claim 1, wherein said body of said septum piercing unit includes opposing first and second major surfaces.
3. A container connector of claim 2, wherein said septum piercing unity further comprising an elongate needle extending through said body thereof, said needle including a first end, a second end, and an elongate tubular body extending therebetween, said first end defining a first needle aperture, said second end defining a second needle aperture, and said tubular body defining an elongate needle passageway extending in fluid communication therebetween, wherein said first end of said needle is the first cannula.
4. A container connector of claim 3, wherein said second end of said needle supports a connector thereon for engaging an elongate conduit having an elongate tubular body defining an open conduit passageway therethrough, said connector placing said conduit passageway in fluid communication with said needle passageway.
5. A container connector of claim 1, wherein said septum piercing unit body is an elongate cylindrical member sized to be positioned in the neck cavity.
6. A container connector of claim 1, wherein said unit body further supports a vent cannula, respectively, extending therefrom, said vent cannula defining a first and second vent port respectively, wherein said unit body further defines an elongate vent passageway extending in fluid communication between said first and second vent ports, wherein in said first position said second vent cannula is positioned in overlying registry with the septum, and in said second position said second vent cannula has pierced the septum.
7. A container connector of claim 1, further comprising an elongate vent needle extending through said unit body, said vent needle including a first end, a second end, and an elongate tubular vent body extending therebetween, said first end defining a first vent needle aperture, said second end defining a second vent needle aperture, and said tubular body defining an elongate vent needle passageway extending in fluid communication therebetween, wherein said first end of said needle is the vent cannula.
8. A container connector of claim 7, wherein said vent cannula supports a porous filtration media, said media defining porous passageways therethrough in fluid communication with said vent passageway.
9. A container connector of claim 1 further comprising a removably connected key for preventing movement of said cap from said first position to said second position.
10. A container connector of claim 1, wherein said cap and the neck include mating helical threads so as guide movement of the cap from said first to said second position.
11. A container connector of claim 10, wherein said cap and the neck include cooperating detents for resisting movement of the cap from the first position.
12. A container connector of claim 11, wherein said cap and the neck include cooperating detents for resisting movement of the cap from the second position.
13. A container connector of claim 1, wherein the septum piercing unit engages the neck so as to prevent rotation of the septum piercing unit along its axis of travel as the cap is moved from the first to the second position.
14. A bottle comprising a neck configured to mate with a container connector of claim 1,
said neck defining a bottle aperture, and including an annular shoulder to support said septum;
said bottle including a bottle body defining a bottle cavity in fluid communication with said bottle aperture;
an elongate tubular dip tube supported in said bottle cavity, said dip tube including a first end, an opposed second end, and an elongate tubular dip tube body extending therebetween, said first end of said dip tube defining a first tube aperture, said second end of said dip tube defining a second tube aperture and said dip tube body defining an elongate dip tube passageway extending in fluid communication therebetween;
wherein said second end of said dip tube is positioned adjacent the septum in underlying registry with the first end of the needle, wherein in the second position, said first end of said needle will be in fluid-tight engagement with said first end of said dip tube so as to place said dip tube passageway in fluid communication with said needle passageway.
15. A bottle of claim 14, further comprising dip tube support member holding said first end of said dip tube adjacent to the septum of the bottle.
16. A bottle of claim 15, further comprising an elongate tubular vent tube supported in said bottle cavity, said vent tube including a first end, an opposed second end, and an elongate tubular vent tube body extending therebetween, said first end of said vent tube defining a first vent tube aperture, said second end of said vent tube defining a second vent tube aperture and said vent tube body defining an elongate vent tube passageway extending in fluid communication therebetween;
wherein said second end of said vent tube is positioned adjacent the septum in underlying registry with the first end of the vent cannula, wherein in the second position, said first end of said vent cannula will be in fluid-tight engagement with said second end of said vent tube so as to place said vent tube passageway in fluid communication with said vent passageway.
17. A bottle of claim 16, wherein said dip tube support member holds said first end of said vent tube adjacent to the septum of the bottle.
18. A synthesis cassette comprising at least one container connector of claim 1.
19. A kit comprising an automated synthesis cassette of claim 18 and a reagent container adapted to engage the container connector.
US14/348,114 2011-09-30 2012-10-01 Container connector Abandoned US20140238950A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US201161541422P true 2011-09-30 2011-09-30
PCT/US2012/058282 WO2013049806A1 (en) 2011-09-30 2012-10-01 Container connector
US14/348,114 US20140238950A1 (en) 2011-09-30 2012-10-01 Container connector

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US14/348,114 US20140238950A1 (en) 2011-09-30 2012-10-01 Container connector

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US20140238950A1 true US20140238950A1 (en) 2014-08-28

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US (1) US20140238950A1 (en)
EP (1) EP2760755A1 (en)
JP (1) JP2015501260A (en)
WO (1) WO2013049806A1 (en)

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JP2015501260A (en) 2015-01-15
EP2760755A1 (en) 2014-08-06

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Effective date: 20140327

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