Note: Descriptions are shown in the official language in which they were submitted.
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DEVICE FOR CONNECTING A RECEPTACLE AND A CONTAINER AND READY-
FOR-USE SET COMPRISING SAME
The invention relates to a device for connecting a closed receptacle and a
container.
The invention also relates to a ready-for-use set comprising, inter alia, a
closed receptacle and
a connection device of the afore-mentioned type.
In the domain of drug-packaging, it is known to store a component of a
medicinal
preparation, such as for example its active ingredient, in a recipient closed
by a stopper of
relatively non-rigid material, for example of elastomer. A liquid may be
introduced into this
recipient after perforation of the stopper in order to dissolve the component
contained in the
recipient or place it in suspension, with a view to obtaining a medicinal
preparation in liquid
form ready to be administered to the patient.
Document WO-A-97110156 discloses a connection device of the afore-mentioned
type
which comprises a base adapted to cover the neck of the recipient and extends
in a flange
forming an inner bore while a plunger is adapted to slide in this bore,
between a position
disengaged with respect to the stopper and a transfer position in which a
hollow needle boi-ne
by the plunger traverses this stopper. The displacement of the plunger from
its disengaged
position towards its transfer position is effected manually by an operator.
During this
manipulation, it happens that the operator exerts on the flange for guiding
the plunger or on
the latter in the course of displacement, a transverse effort which may result
in a perforation of
the stopper in an inclined direction with respect to a central axis of
symmetry of the stopper.
The functional clearance between the plunger and the inner bore of the base
cannot be reduced
too significantly in order to allow a better axial guiding of the plunger, as
the effort resisting
the displacement of the plunger would in that case be too great. The risk of
an inclined or
"slantwise" perforation of the stopper is therefore non-negligible, in
particular
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when the user has to prepare a medicament urgently.
The consequence of a slantwise perforation of the stopper is that the apparent
section
of the orifice, created in the stopper by the passage of the hollow needle, is
greater than the
outer diameter of this needle, to such an extent that leakages may be produced
through the
stopper, around the hollow needle. In particular, when the recipient and the
container with
which it is associated are placed in a position of flow by gravity of the
reconstituted
medicament from the recipient towards the container, i.e. when the recipient
is placed above
the container, it is possible that the medicinal preparation flows from the
recipient towards the
plunger and flows over the user's hands, which may be dangerous for certain
medicaments or
unpleasant for less aggressive medicaments.
It is a more particular object of the invention to overcome these drawbacks by
proposing an improvement in the known systems which allow their tightness to
be guaranteed,
including in the case of slantwise perforation of the stopper that they
comprise.
The device of the invention is characterized in that it comprises a sealing
lip arranged
on an internal surface of the bore opposite the plunger or on a surface of the
plunger, this lip
being shaped to be in tight abutment against the plunger or against an
internal surface of the
bore, in the transfer position of the plunger.
Thanks to the invention, there is created a volume of containment around the
hollow
needle, between the plunger and the internal surface of the bore, this volume
of containment
making it possible to retain liquid possibly leaking outside the recipient
through the orifice
formed in the stopper by the hollow needle.
According to a first, advantageous variant embodiment of the invention, the
base
comprises a wall bearing against an outer part of the stopper, the lip being
shaped on a face of
this wall oriented towards the plunger. According to a second, advantageous
variant
embodiment, the lip is shaped on a front face of the plunger oriented towards
the stopper.
According to another advantageous variant embodiment, the lip is shaped on an
inner radial
surface of the flange or
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on an outer radial surface of the plunger.
In any case, the lip may be provided to present, in transverse section, an
asymmetrical
profile inducing a privileged direction of deformation. This aspect of the
invention guarantees
an adequate positioning of the lip when the plunger is in transfer position,
this adequate
positioning guaranteeing the desired seal.
According to another advantageous aspect of the invention, the flange bears,
on its
inner radial face, a circular ring adapted to cooperate with a corresponding
shoulder of the
outer radial surface of the plunger in order to lock this plunger in the
transfer position.
Locking of the plunger has the effect of precisely fixing the position of the
plunger and
consequently the crushing or deformation of the sealing lip, which ensures a
tight contact
between the lip and the surface with which it must cooperate. The ring may be
provided to
present an asymmetrical tranverse section, the face of the ring oriented
towards the opening of
the bore being less inclined with respect to the inner radial surface of the
flange than the face
of the ring oriented towards the stopper. This arrangement allows the ring
not, or hardly, to
hinder the movement of slide of the plunger in the direction of the stopper,
from its
disengaged position towards its transfer position, while it may efficiently
oppose a movement
of the plunger in the opposite direction. The ring is advantageously adapted
to separate an
annular volume defined in the bore around the front part of the plunger in
transfer position, in
tight manner from the ambient atmosphere. In that case, the ring performs a
function of seal
which is added to that of the lip mentioned hereinbefore.
The invention also relates to a ready-for-use assembly comprising a closed
recipient
containing a product, this recipient comprising a neck whose opening is
obturated by a stopper
made of relatively non-rigid material, and a connection device as described
hereinabove,
mounted on the recipient. Such an assembly makes it possible to conserve a
component of a
medicament, such as its active ingredient, sterile, and to prepare it when
required by mixture
with a liquid, without risk of dangerous or unpleasant leakage.
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The invention will be more readily understood and other advantages thereof
will
appear more clearly on reading the following description of three embodiments
of a
connection device in accordance with its principle, given solely by way of
example and made
with reference to the accompanying drawings, in which:
Figure 1 is a longitudinal section, in exploded view, of a connection device
according
to the invention and of a recipient on which it is provided to be mounted.
Figure 2 is a longitudinal section of the device of Figure 1 mounted on the
recipient,
the whole being in a configuration of storage.
Figure 3 is a longitudinal section similar to Figure 2 while the plunger of
the device
has been displaced towards a transfer position between the inner volume of the
recipient and
the outside.
Figure 4 is a view on a larger scale of detail IV of Figure 3.
Figure 4A is a section on a larger scale of the sealing lip of the device at
rest, i.e. in the
position of Figure 2.
Figure 4B is a view on a larger scale of detail B of Figure 4.
Figure 5 is a view similar to Figure 4 for a device in accordance with a
second
embodiment of the invention, and
Figure 6 is a view similar to Figure 4 for a device in accordance with a third
embodiment of the invention.
The device 1 according to the invention has a dual function. On the one hand,
it
renders tamperproof a recipient 2, for example a glass flask, containing a
product (not shown)
and previously closed or stoppered. On the other hand, it ensures or
establishes a tight
connection between the interior of the recipient 2 and the interior of another
container 2',
shown in dashed and dotted lines in Figure 3, this container being able to be
a supple bag
containing a liquid intended to dissolve or place in suspension the product
contained in the
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recipient 2, for example the active ingredient of a medicament.
The recipient 2 comprises a neck 3 whose opening 3a is hermetically stopped by
a
stopper 4, made of a relatively non-rigid material, for example elastomer and
in particular
rubber. The neck 3 comprises an outer annular bead 3b serving for assembly and
fixation of a
5 base 5.
The stopper 4 comprises a cylindrical central part 4a, adapted for a supple
and tight fit
inside the opening 3a of the neck 3, and a flattened outer part 4b shouldered
on the bead 3b.
The base 5 is made in one piece of a plastics material which is relatively
hard with
respect to the material constituting the stopper 4. It comprises a plurality
of hooking teeth 6
provided to be disposed around the bead 3b of the neck 3, in the manner shown
in Figure 2
and in accordance with the technical teaching of WO-A-97/10156.
The base 5 comprises a wall 8 bearing on the part 4b of the stopper 4, this
wall being
provided with a central recess 8a whose function will be explained
hereinafter. The wall 8
also bears two circular ribs 8b and 8c oriented towards the stopper 4 and
provided to penetrate
in the outer part 4b of the stopper 4, with the result that they create a
tight barrier between the
wall 8 and the stopper 4. The base 5 extends in a flange 9, oriented opposite
the teeth 6 with
respect to the wall 8 and of which the inner radial surface 9a defines a bore
A of substantially
circular section.
A plunger 10 is provided to slide inside the bore A in a direction defined by
the axis of
symmetry X-X' of this bore, which axis is also the axis of symmetry of the
base 5 around
which the teeth 6 are distributed.
The plunger 10 comprises a section l0a substantially perpendicular to the axis
X-X'
and a skirt 10b in the form of a cylindrical sleeve centred on axis X-X'. A
hollow needle 11
borne by the section l0a of the plunger 10 is centred on axis X-X'. The skirt
lOb of the
plunger 10 bears a shoulder lOc while the flange 9 is provided with a
peripheral inner
projection 9b at the level of the opening of the bore A. As is more
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clearly visible in Figure 2, the plunger 10 may be introduced inside the bore
A, by elastic
deformation of the flange 9, in a position such that the shoulder lOc is in
contact with the
projection 9b, the plunger 10 in that case being locked inside the bore A. In
this position, the
needle 11 is disengaged with respect to the stopper 4, i.e. does not perforate
this stopper.
A cap 12 is provided to be disposed around the assembly formed by the base 5
and the
plunger 10 and comprises a lower ring 13, adapted to lock the teeth 6 of the
base 5 around the
neck 3, and a breakable part 14 intended to protect the plunger 10 in the
position of Figure 2,
this breakable part being connected to the ring 13 by a line of break 15.
When it is necessary to use the product contained in the recipient 2, it
suffices to
separate the breakable part 14 from the rest of the cap 12 in order to have
access to the plunger
10 which may in that case be pushed in the direction of the recipient 2 in
order to reach the
transfer position shown in Figure 3 in which the needle 11 has traversed the
recess 8a of the
wall 8 and perforated the stopper 4.
In order that a user can effectively displace the plunger 10 in the direction
of the
stopper 4, the radial clearance J between the surface 9a and the skirt 10b
must not be too
small, otherwise the device would risk being blocked. It is therefore not
excluded that the
orifice 20, fonned by the needle 11 in the stopper 4 and which is of
cylindrical shape, has an
axis slightly inclined with respect to axis X-X', which has been represented,
in exaggerated
manner, with axis Y-Yin Figure 4.
According to the invention, the face 8d of the wall 8 oriented towards the
plunger 10
bears a lip 22 directed towards the front face 10d of the section 10a of the
plunger 10. The lip
22 is in one piece with the wall 8, itself in one piece with the rest of the
base 5 which is made
of plastics material harder than the stopper 4, but presenting a suppleness
allowing
deformation of the lip 22.
The lip 22 is circular, i.e. extends over a circumference centred on axis X-
X', with the
result that,
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when it is in contact with the front face 10d of the plunger 10, it closes a
volume V for
containment of a possible leakage of liquid through the orifice 20, this
volume being
represented in grey tint in Figure 4.
At rest and as shown in Figure 4A, the lip 22 has an asymmetrical cross
section in the
form of an inclined tooth. The angle of inclination a of its outer face 22a
with respect to a
normal N to the face 8d is greater than the angle 0 of its inner face 22b with
respect to a
normal N' to the face 8d. The edge 22c of the lip 22 projects inwardly with
respect to the foot
22d of the inner face 22b. In this way, the direction of crushing of the lip
22 upon abutment of
the front face 10d is turned towards axis X-X' so that the tightness is
effected with the outer
face 22a of the lip 22 having a tangent substantially parallel to the front
face 10d of the
plunger 10, which guarantees an optimal seal, including when the pressure of
the plunger 10
on the lip 22 is not very high.
The lip 22 exerts on the plunger 10 an effort of reaction which increases when
liquid is
present in the volume V, this liquid exerting a pressure on the inner face 22b
of the lip 22,
which pressure tends to return the lip 22 into its configuration of Figure 4A.
A ring 24 is provided on the inner radial surface 9a of the flange 9, at such
a height
with respect to the wall 8 that it cooperates with the shoulder 10c of the
skirt l Ob to block the
plunger 10 in the transfer position of Figures 3 and 4. The ring 24
advantageously extends
over the whole circumference of the surface 9a and presents, in transverse
section and as
shown in Figure 4B, a face 24a directed towards the opening of the bore A and
a face 24b
directed towards the bottom of this bore, i.e. towards the stopper 4 and the
wall 8.
The angle of inclination S of the surface 24a with respect to the surface 9a
is of the
order of 30 , while the angle of inclination y of the surface 24b with respect
to this same
surface is of the order of 60 . This asymmetrical shape of the ring 24 allows
it not to oppose
the movement of drive of the plunger 10 inside the bore A too strongly, as the
face 24a is
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hardly inclined with respect to axis X-X', while it efficiently locks the
shoulder 10c thanks to
the considerable inclination of its face 24b.
The function of locking of the ring 24 makes it possible to guarantee that an
adequate
pressure is exerted by the plunger 10 on the lip 22 in order to obtain a
satisfactory seal.
As the ring 24 extends over the whole periphery of the surface 9a, it also
contributes to
the seal of the whole of the device 1 insofar as liquid, which might reach to
outside the
volume V due to a leakage at the level of lip 22, would remain contained in
the volume V'
defined between the front face 10d and the wall 8 outside the lip 22 and by
the annular
clearance J between the skirt 10b and the surface 9a, at the level of the
front of the plunger 10.
The ring 24 therefore has a dual function of locking and of sealing.
In the second embodiment of the invention shown in Figure 5, elements similar
to
those of the embodiment of Figures 1 to 4 bear identical references increased
by 50. The
device of this embodiment differs from the preceding one essentially in that
the sealing lip 72
is borne by the front face 60d of the plunger 60 and provided to come into
contact with the
upper face 58d of the partition 58 of the base 55. The lip 72 therefore makes
it possible to
define a volume V for containment of a possible leakage of liquid. A ring 74
is also provided
on the inner radial surface 59a of the flange 59 for locking the plunger 60 in
position with
respect to the base 55 and in order to constitute a second sealing barrier for
a second closed
volume V. The plunger 60 bears a shoulder 60c adapted to cooperate with the
ring 74. The
front face 60d of the plunger 60 bears a groove 76 inside which is immobilized
the lip 72
which may be made of a material distinct from that of the plunger 72 and, in
particular, of a
more supple material allowing an increased deformation during abutment of the
plunger 60
against the wall 58, in order to improve seal.
The lip 72 is immobilized in the groove 76 by any appropriate means and, in
particular, by cooperation of shapes and/or adhesion.
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In the third embodiment of the invention shown in Figure 6, elements similar
to those
of the embodiment of Figures 1 to 4 bear identical references increased by
100. A sealing lip
122 is provided on the inner radial surface 109a of the flange 109 opposite
the outer radial
surface 1 I0e of the skirt 110b of the plunger 110 to define a volume of
containment V. As
before, a ring 124 is provided on the surface 109a for immobilizing a shoulder
110c of the
plunger 110 with respect to the base 105 in the transfer position. It also
performs the role of
sealing barrier for a second closed volume V.
According to a variant of the invention (not shown) and taking a mirror
solution with
respect to that of the embodiment of Figure 6, the sealing lip might be borne
by the outer
surface 110e of the skirt 110. Similarly, the skirts 22 and 122 might be
constituted by
elements added on the base, in accordance with a technique similar to that
evoked with
reference to the embodiment of Figure 5. Of course, the lip borne by the
plunger in the
embodiment of Figure 5 might also be in one piece with this plunger.
It will be noted that the lips 72 and 122 have an asymmetrical profile, like
lip 22,
which gives them a privileged direction of deformation.
It is possible to provide for the ring 24, 74 or 124 to be fonmed by discrete,
i.e. non-
contiguous angular sectors, in which case it efficiently performs its function
of locking but
does not participate in the seal of the volume V.
Whatever the embodiment considered, the immobilization of the plunger 10, 60
or 110
thanks to ring 24, 74 or 124 guarantees a constant positioning of the needle
11 or equivalent,
with respect to the recipient 2, with the result that the lost volume of the
recipient 2, i.e. the
quantity of product contained in the recipient which cannot be recovered due
to the distance
between the end of the needle 11 and the neck of the recipient, is constant
from one device to
another. The quantity of product introduced in the recipient 2 or equiva-
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lent before its obturation by the corresponding stopper can therefore be
determined with
precision, taking into account this constant lost volume.
It will be noted that the invention is applicable independently of the mode of
fixing the
base 5 on the recipient 2 and, generally, that it may be used in any
connection device
5 comprising a plunger, mobile inside a bore of a base mounted on a recipient.
