[0001] The present invention, as stated in the title of this Specification, comprises a
plastic device manufactured by injection, provided with a canule sharpened at both
ends, adapted to be connected at one end to the appropriate access piece of a flexible
container and, at the other end, to the top of a vial containing a liquid or powder
which, by piercing of both containers with the canule, allows the transfer of liquids
from the flexible container to the vial and from the latter to the flexible container,
once its content is dissolved or diluted in the transferred solution, without the
need to disconnect the initial connection at any moment of the process.
[0002] The device is characterized in being manufactured from such materials capable of
being chemically or thermically sterilized, being apirogens and compatible with the
solutions with which they are brought into contact.
[0003] The device can be manufactured with various shapes at the ends, in accordance with
the kind of vial and flexible container to which it is going to be engaged. For example,
as illustrative and in no way limitative, vials with a 13 mm, 22 mm or 32 mm diameter
mouth, flexible containers with 50 ml, 100 ml, 250 ml, 500 ml, 1,000 ml, 21, 31 capacity
with threaded coupling which can have different pitches or be engaged under pressure.
[0004] The essential feature of the device is that it is comprised of a stainless steel
canule, firmly held to an injected plastic piece, bell-shaped at one end, with suitable
dimensions for attaching to the vial mouth, and of another piece of injected plastic,
in which the preceding piece internally slides and integral with the canule, so that
in the most extended position the ends of the canule do not protrude beyond the ends
of the device and, once slid, pierce the flexible container; this piece has at one
end the shape of a chamber with appropriate design to be attached to the coupling
of the flexible container.
[0005] An illustrative embodiment is next described in more detail and by no way limitative,
of the object of the invention, making reference to the accompanying drawings, wherein:
Figures 1, 2 and 3 respectively represent an axial lengthwise section, a side and
front views of the canule and of the injected plastic piece integral with it.
Figures 4, 5 and 6 respectively represent an axial lengthwise section, a side and
front views of the injected plastic piece, inside which the piece integral with the
canule slides.
Figure 7 represents an axial lengthwise section of the assemblied arrangement of the
canule and the two injected pieces.
Figure 8 represents a side view of the arrangement in its most extended position,
with the canule retracted and concealed.
Figure 9 represents a side view of the arrangement, engaged with the flexible container
and with the piece integral with the canule, slid to its less extended position, to
pierce the container with the canule.
[0006] As can particularly be seen in Figure 1, the canule 1 has the shape of a hollow cylinder,
with both ends sharpened, and of a suitable length to be able to remain concealed
until the time of use, which can be seen in Figure 7.
[0007] In the same Figure 1, it is seen that the injected piece is bell-shaped 2 at one
end, with an inner diameter slightly larger than the outer diameter of the capsule
of the vial with which it is engaged, and of a suitable length, so that on pressing
the vial down to the bottom of the bell the canule pierces the cap of the vial and
penetrates into the vial sufficiently to issue out of the interior of the cap.
[0008] To prevent ready release of the vial from the device, the bell has at one end some
bulges 3 directed toward the inside to clamp the top of the vial; these bulges likewise
hinder insertion of the top of the vial into the bell, whereby said bell has several
openings 4, distributed symmetrically in order to facilitate insertion of the top
of the vial.
[0009] Next to the bell it is seen that the injected piece clamps the canule, along most
of its length, with a non-cylindrical section shape 5, whose purpose is to strengthen
the canule, preventing it from folding on piercing and, thanks to its shape, engaging
with the piece represented in Figures 4 and 6, allowing lengthwise sliding, but not
the rotation of one piece with respect to the other. At the opposite end of the bell
2, the piece again has a cylindrical shape 6, of greater diameter than the non-cylindrical
one 5, this increase having as its purpose to avoid separation of the two pieces once
assembled; to facilitate mounting, this cylindrical zone is discontinued with hollow
zones 7 by way of longitudinal grooves as can be seen in Figure 3.
[0010] As can be seen particularly in Figure 4, the injected piece, which will serve as
guide and protection for the canule, has a zone of internal circular section shape
8, of appropriate length for concealing the canule in the most extended position of
the device, as can be seen in Figure 8, and to produce the piercing of the flexible
container in the most retracted position of the device, as can be seen in Figure 9;
externally it has a grooved shape 9, in order to facilitate handling of the device,
preventing slipping on being grasped with the fingers.
[0011] At one end the piece has internally modified its section, adopting a non-cylindrical
section shape 10 like the non-cylindrical section zone 5, with a small clearance to
facilitate lengthwise sliding of the pieces; this zone having the narrowing with respect
to the circular section zone 8 allows, along with zone 6, avoidance of separation
of the two pieces once assembled.
[0012] At the other end the piece comprises a chamber 11, which can have male screw fillets
12 of luer, luer lock, record type or any other suitable kind of screw pitch or shape
for attaching to the supplementary coupling of the flexible container.
[0013] Once the cap of the vial is pierced with the canule 1, and the vial attached in the
bell 2, the device is engaged to the flexible container by pressure screwing or equivalent
action, in accordance with the kind of coupling 12 involved. This engagement is facilitated
through the non-cylindrical section zones 5 and 10 which force the pieces and the
canule to turn together. By pushing, exercised between the vial, or on the outer part
of the bell 2, the piece joined to the canule slides internally to the piece engaged
to the flexible container, until piercing said container, along the suitable lengths
of this piece and of the canule.
[0014] Although one embodiment of the invention has been described and represented, it is
evident that modifications can be introduced into it, comprised within the scope of
same, and it should not be considered limited to said embodiment, but solely to the
content of the following:
1. Device for the transfer of liquids between flexible containers and vials, characterized
in that it is comprised by a stainless steel canule (1) joined to a plastic piece
partially surrounding it and protruding on one side to the interior of a bell-shaped
thickening adapted to engage to a vial, sliding at the other end, where the piece
of a needle protrudes, inside a piece which protects said protruding part of the needle,
and which is applied at its free end to a flexible container.
2. Device according to claim 1, characterized in that the stainless steel canule (1)
has both ends tapered and sharpened a suitable length so that, in the most extended
position of the device, the canule (1) will not protrude therefrom and, in the most
rectracted position, protrude from the protection piece, a sufficient length to pierce
the flexible container.
3. Device according to claim 1, characterized in that the bell-shaped thickening (2)
of the plastic piece integral with the canule is of dimensions adapted to the top
of the vial to which it is desired to transfer the liquid and is then provided with
some bulges (3) directed inwardly, adjacent to the free edge of the bell, to avoid
separation of the vial, and axial openings (4) beginning on said free edge, facilitating
insertion of the top of the vial, and in that the outer area of said bell (2) surrounding
integrally the canule (1) has a non-cylindrical smaller transversal cross-section
(5), whose opposite end has a thickening to serve as stop to a corresponding thickening
of the end of the protection piece and to avoid separation of the same, said thickening
having a cylindrical profile (6) provided with wide grooves parallel to the axis of
the canule (1), to facilitate engagement to the two plastic pieces.
4. Device according to claim 1, characterized in that the protection piece of the canule
(1), which also serves as guide for the piece integral with the canule, has a cylindrical
transversal cross-section (8) bore with a diameter slightly larger than that of the
broadened end of the canule piece, to allow lengthwise sliding of one piece with respect
to the other, while the narrowing of the inner end of the same has a non-circular
transversal cross-section, conjugated from the transversal section of the part surrounding
the canule, with sufficient space to allow mutual sliding lengthwise, but not to turn,
and likewise avoiding the separation of both pieces.
5. Device according to claim 4, characterized in that the protection piece of the canule
(1) has its outer surface grooved (9) in axial direction to improve manual attachment
of the same.
6. Device according to claim 4, characterized in that the outer or free end of the protection
piece has a thickening provided inside with a screw or other type of suitable attachment
to engage the device to the flexible container.