U.S. patent application number 14/348114 was filed with the patent office on 2014-08-28 for container connector.
The applicant listed for this patent is GE HEAL THCARE LIMITED. Invention is credited to Alexander Jackson.
Application Number | 20140238950 14/348114 |
Document ID | / |
Family ID | 47074894 |
Filed Date | 2014-08-28 |
United States Patent
Application |
20140238950 |
Kind Code |
A1 |
Jackson; Alexander |
August 28, 2014 |
CONTAINER CONNECTOR
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.
Inventors: |
Jackson; Alexander;
(Amersham, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
GE HEAL THCARE LIMITED |
LITTLE CHALFONT |
|
GB |
|
|
Family ID: |
47074894 |
Appl. No.: |
14/348114 |
Filed: |
October 1, 2012 |
PCT Filed: |
October 1, 2012 |
PCT NO: |
PCT/US2012/058282 |
371 Date: |
March 28, 2014 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61541422 |
Sep 30, 2011 |
|
|
|
Current U.S.
Class: |
215/247 |
Current CPC
Class: |
B65D 51/002 20130101;
B65D 51/1672 20130101; B01L 3/523 20130101; B65D 51/222 20130101;
B01L 2300/044 20130101; B65D 51/225 20130101; B01L 2300/0672
20130101; B01L 2400/0683 20130101; B01L 2300/048 20130101 |
Class at
Publication: |
215/247 |
International
Class: |
B65D 51/00 20060101
B65D051/00 |
Claims
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.
Description
FIELD OF THE INVENTION
[0001] 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
[0002] 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.
[0003] The FASTlab.RTM. 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.
[0004] 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
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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
[0009] FIG. 1 depicts an exploded view of a bottle incorporating a
container connector of the present invention.
[0010] FIG. 2 depicts a cap and septum-piercing unit of the present
invention.
[0011] FIG. 3 depicts a cross-sectional view of the container
connector in a first position, before `activation`
[0012] FIG. 4 depicts a cross-sectional view of the container
connector in a second position, after `activation`
[0013] FIG. 5 depicts an automated synthesis cassette incorporating
a container connector of the present invention between the cassette
and a reagent container.
[0014] FIG. 6 depicts a support member which may be employed with a
container connector of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0015] 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: [0016] i) additional reagent to be used with a fully
pre-assembled automated synthesis cassette; [0017] ii) simplified
operation by the end user with reduced chances of production
failure; [0018] iii) maintaining integrity of a reagent container
until `activation` before use; [0019] iv) connection to be made
without exposing the operator to sharp needles; and [0020] v) other
applications where connection between a container and a fluid
conduit are required, including, e.g., source vials and or product
collection vials.
[0021] 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.
[0022] 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.
[0023] 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.
[0024] 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.
[0025] 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.
[0026] 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.
[0027] 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.
[0028] 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.
[0029] 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.
[0030] 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.
[0031] 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.
[0032] 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.
[0033] 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.
[0034] 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.
[0035] 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.
[0036] 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.
[0037] 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.
[0038] 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.
[0039] 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.
[0040] 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.
* * * * *