U.S. patent number 3,916,893 [Application Number 05/455,014] was granted by the patent office on 1975-11-04 for single-injection device.
This patent grant is currently assigned to Hoechst Aktiengesellschaft. Invention is credited to Wilfried De Felice.
United States Patent |
3,916,893 |
De Felice |
November 4, 1975 |
Single-injection device
Abstract
A single-injection syringe, including a liquid container to be
filled with the medicament, and holding at its sealed lower end a
shortened or long syringe body which, in its interior, carries a
movable needle support and forms with a piston rod a sterile
chamber.
Inventors: |
De Felice; Wilfried (Kelkheim,
Taunus, DT) |
Assignee: |
Hoechst Aktiengesellschaft
(Frankfurt am Main, DT)
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Family
ID: |
5876145 |
Appl.
No.: |
05/455,014 |
Filed: |
March 26, 1974 |
Foreign Application Priority Data
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Mar 28, 1973 [DT] |
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2315367 |
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Current U.S.
Class: |
604/193; 604/206;
604/228 |
Current CPC
Class: |
A61M
5/2466 (20130101) |
Current International
Class: |
A61M
5/24 (20060101); A61M 005/00 () |
Field of
Search: |
;128/218NV,221,218R,218D,218DA,218P,218N,218M |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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1,232,259 |
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Oct 1960 |
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FR |
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523,179 |
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Mar 1956 |
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CA |
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1,205,021 |
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Sep 1970 |
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GB |
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1,151,222 |
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May 1969 |
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GB |
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248,016 |
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Jul 1966 |
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AU |
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Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Opitz; Rick
Attorney, Agent or Firm: Curtis, Morris & Safford
Claims
I claim:
1. A single-injection syringe, comprising a container for a
medicament; said container having first and second open end
positions; said first end portion of the container having a
penetrable seal mounted therein for sealing said first end portion,
and said second end portion having a piston inserted therein to
define with said seal a chamber for containing the medicament; a
syringe body mounted on and surrounding said first end portion of
the container; said syringe body having a penetrable end wall
extending across said first end portion of the container and an
elongated generally cylindrical sleeve integrally formed with and
extending from said wall; said sleeve having an elongated bore
formed therein extending from said end wall to an open end located
in spaced relation from said end wall and a threaded external
periphery; a needle support mounted in said bore for movement
between first and second positions therein; said needle support
having a diameter which is slightly less than the diameter of said
bore and including an annular projection formed thereon and at
least four stabilizing fins extending perpendicularly thereto into
engagement with the bore; a needle mounted in said support having
an end portion located within said bore in the first position of
the needle support and piercing said end wall and said seal as it
is moved to its second position; said bore of said sleeve having a
pair of spaced annular grooves formed therein respectively defining
the first and second positions of said needle, said groove
receiving and cooperating with said annular projection on the
needle support to hold the needle support in its respective
positions against inadvertent movement in the sleeve; and a hollow
plunger including a first end portion threadably engaged with said
threaded sleeve and operatively engaged in bearing engagement with
said support, and a second end portion having means formed on the
exterior thereof for engaging said piston when the plunger is
removed from the sleeve; said needle support also including an
annular shoulder formed thereon; and said plunger having an annular
socket formed therein at its first end portion operatively engaging
said annular shoulder in bearing engagement to urge said support
towards the syringe body to cause the needle to pierce the end wall
and seal upon rotation of the plunger on the sleeve when the
plunger is rotated on the sleeve in a direction to move it towards
the syringe body, said plunger having an elongated chamber formed
therein receiving said needle, whereby said needle support forms,
with the end wall of said syringe body an enclosed sterile chamber
for the needle and is moved from its first to its second position
to cause said needle to pierce said end wall and said seal when
said plunger is threaded on the sleeve in a direction to move it
towards the syringe body.
2. A syringe as claimed in claim 1 wherein said seal is a rubber
stopper and has a conical cavity formed therein opening towards
said chamber at the position at which the needle will pierce the
seal.
3. A syringe as claimed in claim 1 wherein said syringe body
extends only about said first end portion of the container and the
liquid container has a flanged-out finger support formed
thereon.
4. A syringe as claimed in claim 1 wherein the syringe body
surrounds the entire container and has, adjacent the second end
portion of the container, radially inwardly extending beads
overlying the container for retaining the liquid container in the
syringe body.
Description
The present invention relates to a single-injection device
consisting of a liquid container of special shape to be filled with
a liquid medicament. The sealed lower end of the container holds a
syringe body which, however, may also cover the liquid container
over its full length. The interior of the syringe body is provided
with a movable needle support and forms a sterile chamber together
with a piston rod.
So-called "ready-to-use" syringes used for a single injection are
already widely employed in the medicinal administration technique.
Owing to the many individual parts of such wholesale articles, the
assembly to be made under sterile conditions involves considerable
cost. Since a ready-to-use syringe is destined for one injection
only, the manufacturer will strive to keep the production costs
thereof as low as possible.
Prior art knows injection devices, in which the medicament to be
injected is stored in a liquid container, shaped as an ampoule
which is pushed into a syringe body. In the final assembly, the
ampoule placed in the syringe body will be pushed in only to such a
point that the assembled injection cannula which reaches into the
interior of the syringe body does not pierce the seal at the front
end of the ampoule. An essential disadvantage of that syringe is
the injection needle fixed in the syringe body, since the needle
portion which projects into the syringe body and the portion of the
ampoule facing it have to be kept sterile. Because of the resulting
space between the liquid container and the syringe body, however,
micro-organisms can penetrate into the sterile zone within a
certain length of time in storage.
The present invention makes it a point to provide a sterile zone
for the injection needle not in the syringe body but in a sealed
and separate part of the device. This is achieved by mechanically
deforming the syringe body proper into engagement with the liquid
container, thus providing a sealed sterile chamber.
The syringe, constructed in accordacne with the present invention,
will now be described in greater detail by way of example only with
reference to the accompanying drawings, in which:
FIG. 1 is a side view of the syringe;
FIG. 2 is a longitudinal cross sectional view of the syringe with
the syringe body shortened;
FIG. 3 is a longitudinal cross sectional view of the syringe with
the syringe body covering the liquid container;
FIG. 3a is a top view of the upper end of the syringe as shown in
FIG. 3.
Referring to the drawings, FIG. 2, A and FIG. 3, B show the syringe
body in its shortened form and in its long form respectively, the
finger support 5 in the first case being part of the liquid
container, whereas in the second case it is part of the syringe
body.
If the liquid container to be filled with the medicament has such a
shape that no means is provided for a firm connection with the
syringe body, the preferred method for securely fastening the
container according to the invention is provided by thermically and
mechanically deforming a projecting portion of the rim 4 (FIG. 3)
of the syring body made of a suitable plastic material by means of
a punch moved in the direction of the container axis so as to form
beads 20 (FIGS. 3 and 3a) to retain the container. These retaining
beads prevent the liquid container from being removed, while
compensating for differences in the total length of the liquid
container, as do also various securing means of injection devices
as presently used, for example stoppers with annular sealing
lamellae or threads or so-called bayonet-type sealings.
To overcome the above-mentioned disadvantages I have now developed
a new syringe system comprising essentially the following three
main parts, as shown in FIG. 1: A container 1 to be filled with a
liquid medicament, a shortened and/or a long syringe body 2 and a
piston rod 3 mounted on the syringe body.
Referring to FIGS. 2 and 3, the liquid container is sealed in a
familiar manner at its rear end by means of a movable piston
stopper 6 and at its lower end by means of an aluminium cap 7
having a central aperture, under which a rubber disk or a rubber
stopper 8 is inserted. The sealing plug of the rubber stopper is
advantageously provided with a conical cavity, through which air
bubbles, which frequently form in the interior of the container
filled with the liquid medicament prior to the application, can
simply be removed by pressing the piston rod.
The liquid container 1 may be separated from a bore 9 holding the
needle support 10, with a cannula 11 passing through, by means of a
plastic membrane 12, which may be injection-molded onto the syringe
body 2, which is made of a plastic material. Moreover, the surface
of the needle support 10 is provided with an annular projection 13
which engages an annular groove 14 cut in the bore 9, thus securing
the needle support 10 in its initial position. This prevents
premature perforation of the membrane 12 and the piercing of the
rubber disk or stopper 8 placed under the aluminium cap 7. Four
stabilizing fins 15, running perpendicular to the plane of the
annular projection 13 on the needle support 10, assure pefect
centering in the bore 9.
The lower end of the needle support 10 is frustroconical,
preferably shaped as a record frustrum 16, and has a shoulder 17,
so that a plastic socket 18 projecting in the interior of the
piston rod 3 can engage the needle support 10. In the case of a
long cannula which, as the same time, is the injection needle, a
frustrum 18 is not required.
The syringe body 2 with the piston rod 3 screwed on and the needle
support 10 located inside it may be sterilized in ways already
known, for example by using gamma rays. The device is secured
against inadvertent twisting of the piston rod 3 by spot welding,
which also presents the advantage of tamper-proof sealing.
In order to operate the syringe of the invention, the piston rod 3
is turned until retained by a stop 21. The projecting end of the
cannula 11 thereby pierces the plastic membrane 12 and the rubber
sealing 8, thus establishing a communication to the injection
solution. The piston rod 3 is then removed by simple reversed
turning and screwed into the piston stopper 6 placed at the upper
end of the medicament container 1.
The injection needle, the size of which depends on the intended
injection, is then placed on the record frustrum 16 of the needle
support 10. It is also possible to use the injection cannula 11,
which projects beyond the frustrum and is firmly connected to the
needle support 10, as an injection needle. The injection device of
the invention is then ready for a single injection of the
medicament in the usual manner.
Compared with the single-injection devices made in accordance with
the present state of the art, the device of the invention has the
advantage that the whole cannula is located in a sterile chamber,
that fractionation of the rubber disk or stopper and thus clogging
of the cannula are avoided to a large extent and that, in the case
of a long syringe body, provision of retaining beads ensures a
locking effect which is superior to conventional types and, inter
alia, ensures perfect aspiration. The retaining beads provide a
reliable means of preventing the liquid container from falling out
of the syringe or being exchanged unintentionally.
* * * * *