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Description  |
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The invention relates to an injection syringe.
In the case of disposable injection syringes, it is known to provide
withdrawable caps for protection of the syringe needle, during transport
and to reduce the risk of an injury. As a rule, the injection syringe is
assembled with a syringe needle of this kind only just before utilisation.
In the case of packaging comestible and luxury food products, and
pharmaceuticals which are to be administered, it is known to provide a
security closure which makes it possible to discover whether a package has
been broached or opened, or not. In the case of injection needles, it is
known furthermore to store these in a plastics material container, for
example a plastics material bag, packed in sterile manner under welded
seal.
The invention has as its object an injection syringe comprising an already
attached needle which is packaged in sterile manner from the time of
filling and until its utilisation, without any complementary protective
measures. Furthermore, the injection syringe should be openable only in a
manner which subsequently clearly discloses the fact that the syringe had
already been opened.
The object of the invention is accomplished with an injection syringe
comprising a syringe body adapted to receive an injection fluid and a
frusto-conically tapered attachment member integral with the syringe body,
the syringe body and the attachment member defining an annular groove
therebetween, and the attachment member defining an outlet opening for the
injection fluid in communication with the syringe body. A membrane closes
the outlet opening. A syringe needle is arranged coaxially with the outlet
opening and a tubular needle element is arranged coaxially with the outlet
opening and in communication with the syringe needle, the tubular needle
element having an end facing the membrane and the membrane being
interposed between the tubular needle element end and the outlet opening.
The injection syringe further comprises a two-part protective cap for the
syringe needle, one part of the cap constituting a securing device for the
cap and including inwardly projecting claw means resiliently engaging the
annular groove, a second part of the cap constituting a needle protection
cap, and a weakened score line frangibly connects the parts of the
protective cap. A two-part device for breaking the membrane whereby the
outlet opening communicates with the tubular needle element extends in the
interior of the protective cap from the attachment member past the score
line to the needle protection cap and essentially consists of a needle
carrier part joined to the protective cap and defining an axial bore
having an open end facing the membrane, a support member part joined to
the tubular needle element, the support member holding the syringe needle
and the support member with the tubular needle element being displaceably
guided in the needle carrier part relative to the membrane in a direction
of the longitudinal extension of the syringe needle for piercing the
membrane, and the tubular needle element being sealingly and slidably
guided in the needle carrier.
In such an injection syringe, the needle protection cap itself may be
utilised for a security seal or closure. Other advantages of the structure
according to the invention emerge from the fact that the needle protection
cap may assure the force-locked connection of the needle with the
attachment member of the phial, simultaneously with its base element, a
sterile seal being secured in this area at the same time. If, for example,
the needle protection cap is joined to the needle carrier by welding or
bonding, it is possible to secure a simple snap-on joint, in which the
needle carrier is sealingly kept in contact with the attachment member,
the sterility is maintained by means of the sealing surfaces and a
contamination is prevented. This snap-on joint is not releasable without a
tool, and since it is possible to select conventional materials as the
material of the protective cap, for example plastics materials, the
application of tools leaves traces detectable with certainty. For
utilisation of the syringe, merely the opening device is removed, e.g. the
weakening score line which is severed, and this is readily possible
without application of tools.
The provision of the closing membrane has the advantage that the medication
is kept exclusively in the sryinge body and that a penetration by air is
reliably prevented. Furthermore, the sterility of the injection syringe is
maintained as before, by incorporation of the score line opening element
within the needle protection cap. By the utilisation of two elements
displaceable with respect to each other, in combination with a membrane,
it is assured that the sterility of the injection syringe is retained even
upon opening the diaphragm.
For a clearer grasp of the invention, the same is described in particular
in the following with reference to the embodiments illustrated in the
drawings wherein,
FIG. 1 shows an injection syringe according to the invention, with a needle
protection cap attached thereto, in axial cross-section;
FIG. 2 shows a partial view of the injection syringe according to FIG. 1
before utilisation;
FIG. 3 shows a reduced partial view of the injection syringe according to
FIG. 2 after removal of the front portion of the needle protection cap;
FIG. 4 shows a modified embodiment of an injection syringe according to the
invention, comprising a closure device situated in line with the syringe
channel and an associated opening device situated inside the needle
protection cap; and
FIG. 5 shows a modified embodiment of a fragmentary view of a closure
device for an injection syringe according to the invention in axial
cross-section.
In FIG. 1, the syringe body receiving the injection fluid is denoted by 1.
The syringe body has a tapered attachment member 2 which is integrally
formed with the syringe body 1. An annular groove 3 is arranged at the
point of transition between the attachment member 2 and the syringe body
1, as a groove-shaped depression. A syringe needle 4 is connected to a
needle carrier 5, preferentially being co-moulded with the same. The
neelde carrier 5 has an annular flange 6 which may be thrust against an
end face 8 of the attachment member 2 facing towards the needle carrier 5,
and a seal 7 is interposed between end face 8 and flange 6. At its end
face 9 facing towards the syringe needle 4, the annular flange 6 is joined
to a two-part protective cap 10 comprising a securing device 11 and a
needle protection cap 12, the joint being obtained by ultrasonic welding.
When assembling the injection syringe for simultaneously securing a sterile
closure, the unit comprising the needle carrier 5, syringe needle 4 and
protective cap 10 is pushed on to the tapered external surface of the
attachment member 2, inwardly projecting claws 13 of the securing device
11 of the protective cap 10 acting as a base element, engaging in the
annular groove 3.
Apart from the base element for force-locked connection of the needle
carrier 5 to the attachment member 2, the protective cap 10 comprises the
needle protection cap 12 surrounding the needle and joined to the base
element line 14.
It is apparent from FIG. 1 that the securing device 11 acting as the base
element, as well as a portion 15 of the needle protection cap 12
surrounding the needle carrier 5, comprise grooving 16. The handling
capacity, in particular the rotatability of the two parts with respect to
each other for the purpose of breaking them apart at score line 14, is
improved in this manner.
After severing the two parts, the needle protection cap 12 engaging over
the needle may be pulled off the protective cap 10 and the injection
syringe may be utilised immediately. An injection syringe of this kind is
illustrated with the needle cap pulled off, in FIG. 3.
A syringe body 18 consisting of glass in most cases, which has integrally
formed with it an attachment member 19, a groove-like depression being
situated between the sryinge body 18 and the attachment member 19 as a
connecting element, and forming part of an injection syringe 17, is shown
in FIG. 4. The attachment member 19 has engaged over it a securing device
21 or rather its tapered jacket, which at the extremity turned towards the
syringe body 18 engages with claw-like projections 22 in the groove-like
depression 20 between the attachment member 19 and syringe body 18. This
projection may be formed by an encircling annular bead or by several claws
engaging only segments of the tapered jacket. The securing device 21 is
integrally joined to a needle protection cap 25 by an opening device 24
formed by a score line 23. The securing device 21 is moreover joined to a
needle carrier 26 in force-locked and shape-comforing manner, for example
by an ultrasonic welding operation. This needle carrier 26 comprises a
support member 27 which may preferentially be conically formed as in the
present embodiment, an annular flange 28 adjacent thereto and a locating
or guiding element 29 in the direction of the syringe body 18. This needle
carrier 26 is preferentially injection molded with the syringe needle 30.
An end face 31 of the annular flange 28 preferably bears via a seal 32,
for example an O-ring, against an end face 33 of the attachment member 19
facing towards the needle carrier. A distance 34 between one flank of the
groove-like depression 20 and the end face 31 substantially corresponds to
a distance between the same lateral flank of the groove-like depression
and the end face 33 of the attachment member 19. It is primarily when no
seal 32 is provided, that the distance 34 is a little smaller in the
unstressed condition of the projection 22 than the corresponding distance
of the attachment member, to assure reliable contact of the end face 31
with the end face 33 of the attachment member 19 and thus of an absolute
hermetical seal. In the embodiment illustrated, the locating element 29
has approximately the same diameter 35 as an outlet opening 36 of the
attachment member 19. A length of the locating element 29 in the direction
of the outlet opening 36 is so dimensioned that it is greater than a
thickness of the projection 22 provided in the same direction, so that
whilst the projections 22 have snapped from the expanded position
indicated by pecked lines into the snapped-in position shown by solid
lines, a central location of the securing device 21 with the locating
element 29 in the outlet opening 36 is assured. A central seat of the
needle carrier 26 and a precise seal between the needle carrier 26 and the
attachment member 19 are secured thereby.
A closure device formed by a liquid-tight diaphragm 38 may be situated in
the area of an end face 37 of guiding elements 29 facing towards the
syringe body 18. An opening device formed by a needle 41 is installed for
piercing this diaphragm and for establishing a communication between the
outlet opening 36 and an injection extremity of the syringe needle 30, or
between the syringe needle channel 39 situated in the syringe needle, and
an injection channel 40 in the needle carrier 26. The needle 41 of the
opening device extends from the extremity of the needle protection cap 25
associated with the tip of the injection needle 30 to just before the
diaphragm 38. If the needle protection cap 25 is opened by being twisted
with respect to the securing device 21, for which purpose the two elements
last referred to may, as apparent from the drawing, be provided--as
already shown in FIGS. 1 to 3--with grooving, or with actuating flanges,
and the needle protection cap 25 is pulled off, the needle tip may be
pushed forward along a distance 43 by means of an actuating element 42
situated on the needle extremity, so that the needle tip pierces the
diaphragm 38 and establishes a communication between the syringe needle
channel 39 and the outlet opening 36. After it has pierced th diaphragm,
the needle 41 is drawn out with the actuating element 42 and the injection
syringe 17 is ready for injection of the injection solution. The piston
provided for this purpose in the syringe body 18, and the actuating device
for the same, as well as the injection solution, are not illustrated and
any such known devices may be utilised for this purpose.
Another modified embodiment of an opening element 59 for a closure device
60 formed by a diaphragm 38, is shown in FIG. 5. The original closure or
opening device of a needle protection cap 25 is again constructed in
accordance with one of the previously described embodiments. The opening
element 59 for the diaphragm 38 is however formed in the present
embodiment by the fact that a needle carrier 61 is associated with a
support member element 62 displaceable with respect to the same, wherein
the syringe needle 30 is integrally co-moulded. This support member
element 62 comprises a tubular needle element 63 projecting in the
direction of the outlet opening 36 of the attachment member 19 which may
be produced from the same plastics material as the support member element
62 or else be formed by a metal element co-moulded in the support member
element 62, or from the same material as the support member element, for
example metal. This needle element 63 is provided with an oblique end
surface at its end 64 facing towards the outlet opening 36. If the needle
protection cap 25 is now separated by breaking the score line 23 and
removed, the support member element 62 may be pushed forward in the
direction of the diaphragm 38 by a combined longitudinal and rotary
displacement indicated by arrows 65 and 66, so that the end 64 pierces the
diaphragm 38. Depending on the nature of the diaphragm, the same may be
separated or merely pierced. A direct communication is established in this
manner between the syringe needle channel 39 of the syringe needle 30 and
the outlet opening 36. If, furthermore, the needle element 63 or an
appropriate attachment member is sealingly located in the needle carrier
61, the sterility is retained absolutely during the opening displacement
and longitudinal displacement of the support member element 62 in the
direction of the arrow 66.
Merely for the record, let it be pointed out that it is evidently also
possible to perform the piercing of the diaphragm merely by a longitudinal
displacement in the direction of the arrow 66 instead of the combined
longitudinal and rotary displacement according to the arrows 65 and 66, or
in the case of an appropriate configuration, for example by an arrangement
of the diaphragm 38 made obliquely to the longitudinal direction of the
outlet opening 36, to open this diaphragm 38 merely by a rotation of the
support member element 62.
In modification of the embodiment illustrated in FIG. 5, it is also
possible however to install a solid needle in the centre of the injection
channel of the needle carrier 61, with which the diaphragm 38 is pierced,
instead of the tubular needle element 63, so that the injection fluid may
penetrate into the syringe needle channel 39 through the opening thus
made.
The structure and arrangement of the closure device and of the opening
member associated with the same are evidently wholly unaffected by the
structure of the opening device of the needle protectin device, and vice
versa. In a logical manner, additional advantages and actions result
however from the combination of these two solutions, in which connection
however, the incorporation of two opening devices formed by score lines
for example, in the extension of a needle protection cap 25, may represent
an independent invention.
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