U.S. patent application number 10/418058 was filed with the patent office on 2003-10-16 for closure device for a medical container.
This patent application is currently assigned to AstraZeneca AB.. Invention is credited to Eek, Arne, Nilsson, Billy.
Application Number | 20030192791 10/418058 |
Document ID | / |
Family ID | 20416420 |
Filed Date | 2003-10-16 |
United States Patent
Application |
20030192791 |
Kind Code |
A1 |
Eek, Arne ; et al. |
October 16, 2003 |
Closure device for a medical container
Abstract
A closure device is designed for attachment on a neck portion
(1) of a separate container (2), preferably of glass material,
which holds a first substance. The closure device defines a passage
(10) extending between opposite first and second openings (11, 13)
of the closure device. A sealing means (30) is arranged to close
off the first opening (11) and confine a second substance in the
passage (10). A penetration means (33) is incorporated in the
device and operable to penetrate the sealing means (30) such that
fluid communication is established between the passage (10) and the
container (2). In a method of mixing the first and second
substances, a medical practitioner exposes the second opening (13)
by removing a non-resealable cap (8), by introducing and engaging
the end of a syringe directly in the second opening (13), and by
operating the penetration means (33) to penetrate the sealing means
(30). By operating the syringe, the practitioner can transfer the
first and second substances to the syringe, and mix the same in the
process, with minimum need for sterilization.
Inventors: |
Eek, Arne; (Trosa, SE)
; Nilsson, Billy; (Mjolby, SE) |
Correspondence
Address: |
FITCH, EVEN, TABIN & FLANNERY
SUITE 401L
1801 K STREET, NW
WASHINGTON
DC
20006-1201
US
|
Assignee: |
AstraZeneca AB.
|
Family ID: |
20416420 |
Appl. No.: |
10/418058 |
Filed: |
April 18, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10418058 |
Apr 18, 2003 |
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09677817 |
Sep 29, 2000 |
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09677817 |
Sep 29, 2000 |
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PCT/SE00/01445 |
Jul 5, 2000 |
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Current U.S.
Class: |
206/222 ;
206/219; 366/130; 604/414 |
Current CPC
Class: |
A61J 1/2096 20130101;
B65D 51/2814 20130101; A61J 1/2055 20150501; A61J 1/2089 20130101;
A61J 1/201 20150501 |
Class at
Publication: |
206/222 ;
206/219; 366/130; 604/414 |
International
Class: |
B65D 025/08 |
Foreign Application Data
Date |
Code |
Application Number |
Jul 7, 1999 |
SE |
9902610-6 |
Claims
1. A closure device for attachment on a neck portion (1) of a
container (2) holding a first substance, said closure device
comprising a first end portion (4) and a second end portion (6), a
first opening (11) being defined in the first end portion (4), a
second opening (13) being defined in the second end portion (6),
and a passage (10) extending within said closure device for fluid
communication between the first and second openings (11, 13),
characterized by a sealing means (30; 30') which closes off the
first opening (11) and confines a second substance in the passage
(10), and a penetration means (33; 33'; 35') which is operable to
penetrate the sealing means (30; 30') such that fluid communication
is established between the passage (10) and the container (2).
2. A closure device according to claim 1, wherein the second
opening (13) is defined in the second end portion (6) to receive
the end of a syringe (S) for fluid communication between the
passage (10) and the syringe (S).
3. A closure device according to claim 1 or 2, wherein the first
end portion (4) is adapted to engage directly or indirectly with
the neck portion (1).
4. A closure device according to any one of claims 1-3, wherein the
penetration means (33; 33') is provided in the passage (10) such
that, when the end of the syringe (S) is received in the second
opening (13), the penetration means (33; 33') is displaced towards
the first opening (11) to penetrate the sealing means (30;
30').
5. A closure device according to claim 4, wherein the penetration
means (33; 33') is slidingly arranged in the passage (10) and has a
first end with a cutting element (40; 40') adapted to rupture the
sealing means (30; 30') and a second end adapted to directly or
indirectly cooperate with the end of the syringe (S).
6. A closure device according to claim 5, wherein the cutting
element (40; 40') is arranged adjacent to the sealing means (30;
30').
7. A closure device according to any one of the preceding claims,
wherein said sealing means comprises a breakable foil (30),
preferably of aluminum material or an aluminum laminate, which is
arranged to close off the first opening (11).
8. A closure device according to any one of the preceding claims,
which is adapted to be directly mounted in an opening defined by
the neck portion (1) of the container (2).
9. A closure device according to claim 5 or 6, wherein the cutting
element (40) is connected to one side of a holder member (35) and
projects from said one side essentially in the shape of an arc,
said arc extending over more than 180.degree. and preferably less
than 360.degree..
10. A closure device according to claim 9, wherein a part of said
arc forms a leading portion (41) for initial penetration of the
sealing means (30).
11. A closure device according to claim 9 or 10, wherein the holder
member (35) is snugly received in the passage (10) and is provided
with at least one through hole (39).
12. A closure device according to any one of claims 5-7, which is
adapted for arrangement on a stopper (20), preferably of rubber
material, fitted in the neck portion (1) of the container (2),
wherein an internal channel (39') extends in the penetration means
(33') from the first end thereof, the penetration means (33') being
arranged such that fluid communication is established between the
container (2) and the passage (10) through the channel (39') after
penetration of the sealing means (30) and the stopper (20).
13. A closure device according to any one of the preceding claims,
wherein the passage (10) comprises a conduit (31) extending from
the second opening (13), and a chamber (32) communicating with the
conduit (31) and the first opening (11), and wherein the
penetration means (33; 33') is guided in the conduit (31) and
extends into the chamber (32), which is wider than the conduit (31)
and contains said second substance.
14. A closure device according to claim 13, wherein the penetration
means (33; 33') comprises a stem (34; 34') which is connected to
the cutting element (40; 40') and extends into the conduit (31),
the outer periphery of the stem (34; 34') being provided with at
least one longitudinal groove (37) defining at least one channel
between the stem (34; 34') and a wall portion of the conduit
(31).
15. A closure device according to any one of claims 1-3, wherein
the penetration means (35') has a first end with a cutting element
(40') adapted to rupture the sealing means (30'), a second end
sealingly fitted to the first opening (11), and an internal channel
(39') in fluid communication with the first and second ends
thereof, wherein said closure device, when mounted on the neck
portion (1) of the container (2), allows for displacement towards
the container (2) such that the cutting element (40') ruptures the
sealing means (30'), thereby providing the fluid communication
between the passage (10) and the container (2).
16. A closure device according to claim 15, wherein the sealing
means (30'), preferably in form of a resilient bonnet, is attached
to first end of the penetration means (35') to close off the
internal channel (39') and thus the first opening (11).
17. A closure device according to claim 15 or 16, wherein the
penetration means comprises a hollow needle (35') which is attached
to and projects from the first opening (11).
18. A closure device according to any one of claims 15-17, wherein
the first end portion (4) has at least two parallel extensions (4')
adapted to engage with the neck portion (1) and to allow for said
displacement while aligning the penetration means (35') with the
container (2).
19. A closure device according to any one of claims 15-18, which is
adapted for arrangement on a stopper (20), preferably of rubber
material, fitted in the neck portion (1) of the container (2).
20. A closure device according to any one of the preceding claims,
wherein the passage (10) is defined in a body (3) comprising a
sleeve element (4, 5) and a lid element (6) including the second
opening (13), the lid element (6) being attached to an open end of
the sleeve element (4, 5) to define the passage (10).
21. A closure device according to any one of the preceding claims,
wherein the second end portion (6) at the second opening (13)
comprises a Luer fitting, such as a Luer Slip fitting or a Luer
Lock fitting.
22. A closure device according to any one of the preceding claims,
which is of unitary construction and adapted to be attached to the
neck portion (1) of the container (2).
23. A closure device according to any one of the preceding claims,
wherein a non-resealable cap (8) is provided at the second end
portion (6) to seal the second opening (13).
24. A closure device according to claim 23, wherein the cap (8) is
attached to the second end portion (6) along a weakened section (9)
thereof.
25. A closure device according to claim 23, wherein the cap is a
foil (8) attached to the second opening (6).
26. A closure device according to any one of the preceding claims,
wherein said second substance is a pH-lowering substance, such as
HCl, or a local anaesthetic, such as lidocaine or ropivacaine.
27. A closure device according to any one of the preceding claims,
wherein said first substance in the container (2) is a
pharmaceutically active drug, preferably propofol.
28. A container having attached thereto a separate closure device
as claimed in any one of claims 1-27.
29. A method of preparing a solution by mixing two substances by
means of a container according to claim 28, comprising the steps of
inserting the end of a syringe (S) into the second opening (13),
operating the penetration means (33; 33'; 35') to penetrate the
sealing means (30; 30'), and operating the syringe (S) to transfer
the first and second substances to the syringe (S).
30. A method according to claim 29, wherein the transfer step
comprises transferring the first substance to the passage (10) to
mix with the second substance confined therein.
Description
[0001] The present invention generally relates to containers, such
as vials or ampoules, for holding and transferring injectable
solutions to a syringe. More specifically, the present invention
relates to a closure device for such containers.
[0002] In general, injection solutions are kept in sterile glass
vials or ampoules, which are closed off by a suitable seal, such as
a rubber stopper or an aluminum foil. Such solutions are injected
into a patient by means of a syringe. There are many different
forms of syringes that are presently available for use by the
medical professions. One particular design difference between
various syringes is the manner in which the open end of the syringe
is shaped to accommodate a hypodermic needle. The two most popular
forms of needle fittings are the friction fit fitting (such as the
Luer Slip fitting), and the combination of screw thread and
friction engagement fitting (such as the Luer Lock fitting). When a
solution is to be injected in a patient, a broad channeled needle
is attached to the fitting at the open end of the syringe. This
needle is used to penetrate the seal, so that the solution in the
vial can be transferred to the syringe. Following transfer, this
broad channeled needle is removed from the syringe and replaced
with a narrower channeled needle suitable for injecting the
solution into the patient. It will be appreciated that this
procedure is costly and complicated since it necessitates the use
of a number of separate components. Furthermore, since solution
transfer for injection into humans requires scrupulous sterilizing
of components, this practice requires separate sterilizing measures
to be taken at each step.
[0003] These difficulties are at least partly alleviated by the
prior art devices known from WO97/39720 and WO98/13006, in which a
closure member is mounted on a stopper fitted in a neck portion of
a container holding a solution. The closure member includes an
axial passage, which extends between first and second openings, the
second opening being adapted to receive the end of a syringe. A
piercing member is arranged in the passage with a piercing tip at
the first opening adjacent to the stopper. The piercing member is
arranged such that it is displaced to penetrate the stopper when
the end of a syringe is received in the second opening. After
penetration of the stopper, the solution can be transferred to the
syringe through a channel defined in the piecing member, without
the need for any broad channeled needle on the syringe itself.
[0004] However, in some cases it is necessary to prepare an
injectable solution by mixing a first substance, liquid or solid,
with a second liquid substance, in given proportions before
administering the solution to a patient. Typically, such mixing is
a complicated procedure, necessitating the use of a number of
separate components. Thus, this practice involves an increased risk
of contamination and therefore requires separate sterilizing
measures to be taken at each step. Further, in many cases the
substances must be mixed immediately before administration to a
patient, at exact proportions, which can be difficult to
achieve.
[0005] The prior art also includes U.S. Pat. No. 5 740 654 which
discloses an assembly intended for extemporaneous preparation of
solutions and suspensions of a solid active product, the product
being enclosed in a container sealed by a stopper fitted in a neck
portion thereof. The stopper has an axial channel covered by a thin
operculum fixed on the outside face of the stopper. To prepare the
solution, a separate connection member is first attached to the
neck portion, whereupon a compressible flask holding a liquid
product and having a pointed tip portion is opened and screwed into
the connection member such that the tip portion of the flask
penetrates the operculum, thereby establishing fluid communication
between the flask and the container. By compressing the flask, the
liquid is caused to pass into the container, where it is mixed with
the active product. Then, the flask is repeatedly compressed to
transfer the solution back to the container, from where it can be
transferred by a syringe, as discussed by way of introduction. This
known device includes several components, and exhibits an increased
risk of contamination. The use of the device involves several
separate steps before the solution can be injected into a patient.
Separate sterilizing measures must be taken at each step.
[0006] The object of the invention is to solve or alleviate at
least some of the problems described above.
[0007] This object is achieved by the closure device, the
container, and the method of preparing a solution by mixing two
substances as set forth in appended claims 1, 28 and 29,
respectively.
[0008] Since the passage is formed such that a substance can be
confined therein, two different substances can be separately
enclosed in one and the same packaging and be mixed with each other
immediately prior to injection. With the inventive closure device
attached to the container, a medical practitioner can access the
contents of the container and introduce, and preferably engage, the
end of a syringe in the second opening of the closure device. Since
both substances enter the syringe from the passage in the closure
device, they will be mixed automatically, in the syringe and/or in
a chamber defined in the passage connecting the first and second
openings. Thus, the inventive closure device both minimizes the
need for sterilization and obviates the need for two different
needles. Further, the inventive closure device comprises a minimum
of parts and is of cost-effective construction.
[0009] The container might contain a unit dose of the first
substance. If another unit dose of the second substance is confined
in the passage of the closure device, the invention provides the
further advantage that the first and second substances will be
automatically mixed in known and precise proportions.
[0010] Preferably, the closure device is of unitary or one-piece
construction. In one variant, the closure device is formed to
replace commonly used seals, such as rubber stoppers or aluminum
foils, fitted to the neck portion of the container. In another
variant, the closure device holding the second substance is mounted
onto an existing conventional seal, such as a rubber stopper or a
foil, on the container holding the first substance. One advantage
of the latter variant is that the sealed container, with respect to
the liquid substance confined therein, can be of conventional
design. This should facilitate and shorten the procedure of
obtaining an approval for the closure device, and a container
having such a closure device, from the competent authorities.
[0011] With the closure device mounted on a conventional rubber
stopper, the penetration means preferably comprises a hollow needle
for facilitated penetration of the stopper.
[0012] Preferably, a non resealable cap is provided at the second
portion to seal the second opening. This allows the medical
practitioner to access the contents of the container by simply
removing the cap to expose the second opening.
[0013] Preferably, the second end portion comprises a Luer fitting
near the second opening, the fitting being adapted for direct fluid
tight engagement with the open end of a syringe.
[0014] According to a first aspect of the invention, the
penetration means is provided in the passage such that, when the
end of a syringe is inserted into the second opening, the
penetration means is displaced towards the first opening to
penetrate the sealing means that closes off the first opening of
the device. Thus, the penetration means is enclosed in a sterile
and confined space, minimizing the need for additional
sterilization steps during use of the inventive closure device. In
one simple construction for penetration of a thin foil closing off
the first opening, the penetration means has a cutting element in
the shape of an arc extending over more than 180.degree. and less
than 360.degree.. Such a cutting element will provide a clean
non-closed cut in the foil and minimize the risk of cut-away foil
portions falling into the container. Preferably, the cutting
element is connected to a stem which extends to the second opening
for engagement with the end of the syringe, the periphery of the
stem being provided with one or more longitudinal grooves to define
a flow path in the passage of the closure device.
[0015] According to a second aspect of the invention, the closure
device as such is displaceable towards the container to establish
fluid communication between the passage holding the second
substance and the container holding the first substance. The
penetration means has a first end with a cutting element adapted to
rupture the sealing means, a second end sealingly fitted to the
first opening, and an internal channel in fluid communication with
the first and second ends thereof. Thus, when mounted on the neck
portion of the container, the closure device can be displaced
towards the container such that the cutting element ruptures the
sealing means, thereby establishing fluid communication between the
passage and the container and allowing for confined mixing of the
first and second substances. Preferably, the sealing means is
attached to the first end of the penetration means to close off the
internal channel, and indirectly the first opening. The second
aspect provides for a device of simple construction, without moving
parts, that can be attached to the neck portion of container, for
example by a releasable snap fit engagement.
[0016] The invention will now be described in more detail with
reference to preferred embodiments of the invention shown in the
accompanying drawings.
[0017] FIG. 1a is a cross-sectional view of a closure device
according to the first aspect of the invention, and FIGS. 1b-1d is
a perspective view, an elevated side view, and a bottom plan view,
respectively, of the penetration means of FIG. 1a.
[0018] FIG. 2 is a cross-sectional view of a variant of the closure
device of FIGS. 1a-1d.
[0019] FIGS. 3a-3b is a perspective view and a cross-sectional
view, respectively, of a closure device according to the second
aspect of the invention.
[0020] Referring to FIGS. 1a-1d, and in particular FIG. 1a, there
is shown a first embodiment of the inventive closure device
according to the first aspect. The closure device is attached to a
neck portion 1 of a container 2, thereby enclosing an injectable
solution therein. The container 2, or at least the neck portion 1
thereof, is generally made of a non-collapsible material, such as
glass. The closure device of the first embodiment has a body 3
comprising an engaging portion 4, which is adapted to mate with and
engage the inner periphery of the neck portion 1. The engaging
portion 4 is joined with a shell portion 5. A spigot 6 extends from
the shell portion 5 to a distal end 7. A flat grip 8 is connected
to the distal end 7 via a weakened portion 9, which has a smaller
wall thickness than the distal end 7. A passage 10 is formed within
the body 3 and extends from a proximate opening 11 defined in an
end surface 12 of the engaging portion 4 to a distal opening 13
defined in the distal end 7, where the passage 10 is closed off by
the grip 8. The spigot 6 defines a fitting for engagement with the
open end of a syringe (not shown), in this case a Luer Slip
fitting, in which the interior of the spigot 6 is adapted to mate
with and frictionally engage the outer periphery of the end of the
syringe, thereby allowing for a temporary fluid tight engagement
therewith.
[0021] A foil 30, preferably of aluminum or aluminum laminate, is
attached to the body 3 of the closure device to close off the
passage 10 at the end surface 12 of the body 3. The closed passage
10 holds a liquid substance, to be mixed with the injection
solution in the container 2, as will be explained below. The
passage 10 consists of a smaller-diameter conduit 31, which is
defined in the spigot 6, and a larger-diameter chamber 32, which is
defined in the engaging portion 4 and in the shell portion 5. The
chamber 32 opens in the end surface 12 and defines the opening 11
therein.
[0022] A pusher 33, which is shown in more detail in FIGS. 1b-1d,
is slidingly arranged in the passage 10. The pusher 33 is
preferably of one-piece construction of a material that is
compatible with the fluids in the container and the passage,
respectively. The pusher 33 comprises an elongate shaft 34 and a
plate 35 at a first end thereof. Elongate recesses 37 extend
between the ends of the shaft 34. The outer periphery of the plate
35 is shaped to be snugly received in the chamber 32. The plate 35
is provided with through holes 39 connecting the opposite sides of
the plate. On the side facing away from the shaft 34, the plate 35
carries an arcuate cutting edge 40 extending essentially in
parallel to the perimeter of the plate 35. For reasons given below,
it is preferred that the cutting edge 40 forms an arc extending
over more than 180.degree. and less than 360.degree.. The cutting
edge 40 comprises an axial projection 41 facilitating penetration
of the foil 30.
[0023] As indicated in FIG. 1a, the pusher 33 is arranged with the
cutting edge 40 adjacent to the foil 30 sealing the opening 11. The
shaft 34 extends through the chamber 32 and into the conduit 31,
such that the second end of the shaft 34 is arranged close to the
opening 13. On penetration, the arcuate cutting edge 40 will form a
correspondingly arcuate cut in the foil 30. This cut will define a
tongue that can be automatically folded into the container 2
without coming loose, thereby minimizing the risk of cut-away foil
portions falling into the container 2.
[0024] To access the contents of the container 2, the user grasps
the flat grip 8 and tears it off at the weakened portion 9, thereby
exposing the distal opening 13 at the distal end 7. Then, the end
of a syringe (not shown) is introduced in the distal opening 13 to
abuttingly engage with the pusher 33. As the end of the syringe is
brought into fluid tight engagement with the Luer fitting formed in
the spigot 6, the cutting edge 40 of the pusher 33 will be
automatically driven through the foil 30 to establish fluid
communication between the syringe and the container 2 via the
passage 10. Thus, when the user operates the syringe to transfer
the solution from the container 2 to the syringe, the solution will
flow via the through holes 39 into the chamber 32, where it at
least partly mixes with the liquid substance contained therein,
before leaving the chamber 32 through channels defined by the
recesses 37 and the walls of the conduit 31. Thus, the first
embodiment allows two different substances to be separately
enclosed in one and the same packaging and mixed with each other
immediately prior to injection. Since both substances enter the
syringe through the opening 13, they will be mixed automatically,
in the syringe and/or in the chamber 32. Following such transfer
and mixing, a hypodermic needle can be attached to the end of the
syringe for injecting the solution into a patient. Alternatively,
the end of the syringe can be brought to direct engagement with an
intravenous cannula or the like.
[0025] The body 3 of the closure device in the embodiment shown in
FIG. 1a is formed in one piece, preferably by injection moulding,
of a plastic material, preferably a nonrigid material such as
polyethylene or polypropylene. In assembly, the pusher 33 is first
inserted into the body 3 through the opening 11 in the body 3.
Then, a liquid substance is filled into the passage 10 through the
opening 11. Finally, the foil 30 is attached to the body 3 to
provide a unitary closure device which can be attached to a filled
container 2 in a subsequent step. With containers 2 that
conventionally are sealed with rubber stoppers, only minor
modification of the sealing equipment is required to replace the
rubber stopper with the closure device. Further, standard filling
equipment can be used.
[0026] In this and the following embodiments, the container can be
filled with a solution of any drug which is suitable for injection
but is particularly advantageous for use with sterilizable
anaesthetic or anaesthetization agents, such as propofol or other
drugs which are used under conditions where the demands for easy
handling and sterility is high. The inventive closure device is
most suited for use with substances that, for example in order not
to exhibit reduced potency, should be mixed immediately prior to
injection into a patient.
[0027] One example of an injection solution is propofol, which is
commonly used both as anaesthetic and as sedative drug. Injection
of propofol is frequently associated with pain on intravenous
administration. The pain can be reduced by addition of a
pH-lowering substance, such as HCl, or a local anaesthetic, such as
lidocaine or ropivacaine. Thus, by enclosing propofol in the
container 2, and a pH-lowering substance or a local anaesthetic in
the closure device attached thereto, these substances can be
administered together.
[0028] A second embodiment of a closure device according to the
first aspect of the invention is shown in FIG. 2, albeit only in an
operative position. As compared with FIG. 1, like elements have
been given like reference numerals and a detailed description of
such elements will not be repeated.
[0029] Similar to the first embodiment, the closure device of the
second embodiment has a body 3 comprising an engaging portion 4, a
shell portion 5, and a spigot 6, the interrelationship of which is
described above with reference to FIG. 1. A stopper 20, preferably
of resilient material such as rubber, is fitted in the neck portion
1 of the container 2 to confine a substance therein. Preferably,
although not shown in FIG. 2, a recess is formed in the top surface
of the stopper 20 to facilitate penetration thereof. A sealing
means in the form of a thin foil 30 is attached to the body 3 of
the closure device to close off the proximal opening 11 and thus
the passage 10. The distal opening 13 is sealed off by a suitable
non-resealable cap (not shown), such as a foil or a grip of the
type shown in FIG. 1a. Like the first embodiment, a pusher 33' is
arranged in the passage 10 of the closure device of the second
embodiment. One end portion 35' of the pusher 33' has the shape of
a broad channeled needle, i.e. a hollow needle with a central
channel 39'. The sharp tip 40' on one end of the needle 35' is
arranged adjacent to the stopper 20. The opposite end of the needle
35' is attached to a shaft 34' (not shown in detail) of similar
construction as the shaft 34 in the first embodiment (see FIGS. 1b
and 1c). Thereby, there is provided a fluid path for the injection
solution from the container 2 to the distal opening 13, via the
chamber 32. In the operative position shown in FIG. 2, the end of a
syringe S has been engaged in the distal opening 13, thereby
driving the needle 35' through the foil 30 and the stopper 20 to
establish fluid communication between the syringe S and the
container 2, via the chamber 32.
[0030] The skilled person realizes that there are many alternative
structures achieving this function. In one example (not shown), the
pusher 33' is a long broad channeled needle which extends into the
conduit 31 and has lateral perforations communicating the interior
channel 39' with the chamber 32. The needle might be connected to
an annular gasket which is slidingly arranged in the conduit 31 to
seal a space defined between the needle and the walls of the
conduit 31. The gasket can guide the needle in the conduit 31 and
provide a surface for engagement with the end of the syringe S. As
a further alternative, there could instead be provided two separate
fluid paths in the closure device; one fluid path for the injection
liquid from the container to the distal opening 13, and another
fluid path for the liquid substance from the chamber 32 to the
distal opening 13, the mixing being performed in the syringe.
[0031] It is also conceivable to fixedly attach the stopper 20 to
the body 3, for example by means of glue or the like, thereby
closing off the proximate opening 11 and forming a unit that can be
directly fitted in the neck portion 1 of the container 2. In this
case, the foil 30 can be omitted.
[0032] In operation and manufacture, the second embodiment is
essentially identical to the first embodiment, and a description
thereof will not be repeated. In essence, the second embodiment
confers similar advantages as the first embodiment.
[0033] An embodiment of a second aspect of the inventive closure
device will now be described with reference to FIGS. 3a-3b. As
compared with FIGS. 1 and 2, like elements have been given like
reference numerals, and a detailed description of such elements
will not be repeated.
[0034] Similar to the above embodiments, the closure device in
FIGS. 3a-3b has a body 3 comprising an engaging portion 4, a shell
portion 5, and a spigot 6, the interrelationship of which is
described above with reference to FIG. 1. Like the embodiments of
FIGS. 1 and 2, the passage 10 consists of a smaller-diameter
conduit 31, which is defined in the spigot 6, and a larger-diameter
chamber 32, which is defined in the shell portion 5. The chamber 32
opens in the end surface 12 and defines the proximal opening 11
therein. A hollow needle 35' with an internal channel 39' is
sealingly fitted in the opening 11 and extends to a sharp tip 40'.
A sheath 30' of resilient material, such as rubber, is slipped over
the needle, thereby forming a bonnet sealing the open tip 40' of
the needle 35'. Thus, the sheath 30' indirectly closes off the
opening 11 and confines a liquid substance in the passage 10. The
distal opening 13 is sealed off by a foil 8. The engaging portion 4
of the closure device comprises two parallel extensions 4' for
snap-fit engagement with the neck portion of a container, which
holds an injection solution and is closed off by a conventional
seal, such as a stopper or a foil. Thus, the closure device of
FIGS. 3a-b is designed for releasable attachment on the container
with the sharp tip 40' being arranged adjacent to the seal.
[0035] The body 3 of the closure device shown in FIGS. 3a-3b is a
two-piece construction, preferably formed by injection moulding of
a plastic material, preferably a nonrigid material such as
polyethylene or polypropylene. More specifically, the body 3 is
formed by joining a lid part, including the spigot 6 and a
peripheral flange at one end thereof, to a sleeve part, including
the shell portion 5 and the engaging portion 4. The lid part is
engaged with the sleeve part at the open end thereof, thereby
forming a non-releasable peripheral snap-fit joint 60. The
two-piece construction reduces manufacturing costs in that the lid
part can be produced with narrow tolerances, as required by the
Luer fitting, whereas the sleeve part can be produced with wider
tolerances. Evidently, the snap-fit joint 60 could be incorporated
in any one of the embodiments of the invention.
[0036] In assembly, the sheath 30' is slipped on the needle 35',
whereupon a liquid substance is filled into the passage 10 through
the spigot 6. Then, the foil 8 is attached to seal the distal
opening 7, thereby providing a unitary closure device that can be
attached to a filled container in a subsequent step.
[0037] To access the contents of the container, the user pushes the
closure device towards the container to drive the tip 40' of the
needle 35' through the seal of the container. In the process, the
extensions 4' align the needle 35' perpendicularly to the seal for
controlled penetration of the seal. While penetrating the seal, the
tip 40' simultaneously penetrates the sheath 30' to establish fluid
communication between the passage 10 and the container. Then, the
user grasps the grip portion 8' and removes the foil 8 to expose
the distal opening 13. Thereafter, the end of a syringe (not shown)
is introduced in the distal opening 13 and brought into fluid tight
engagement with the Luer fitting formed in the spigot 6. When the
user then operates the syringe to transfer the solution from the
container to the syringe, the solution will flow into the chamber
32, where it at least partly mixes with the liquid substance
contained therein, before leaving the chamber 32 through the
conduit 31.
[0038] It is to be understood that various alterations,
modifications and/or additions may be introduced into constructions
and parts previously described without departing from the spirit or
ambit of the invention as defined in the following claims. In one
conceivable alternative, the closure device is formed integrally
with the container.
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