U.S. patent application number 13/577007 was filed with the patent office on 2013-01-10 for connector for a container including a medicinal active ingredient.
This patent application is currently assigned to Fresenius Kabi Deutschland GmbH. Invention is credited to Torsten Brandenburger, Ismael Rahimy.
Application Number | 20130008561 13/577007 |
Document ID | / |
Family ID | 42753422 |
Filed Date | 2013-01-10 |
United States Patent
Application |
20130008561 |
Kind Code |
A1 |
Rahimy; Ismael ; et
al. |
January 10, 2013 |
CONNECTOR FOR A CONTAINER INCLUDING A MEDICINAL ACTIVE
INGREDIENT
Abstract
The invention relates to a connector for containers containing
medicinal active ingredient, which connector makes it possible to
transfer active ingredient from one container into another
container. The connector (1, 1') according to the invention
comprises a first connection region (3, 3') for the connection of a
first container (2, 2'), a guide element (4, 4'), a piercing
element (5, 5') and a partition wall (6), wherein the guide element
(4, 4') has a duct (7) designed for transferring a medicinal active
ingredient, the piercing element (5, 5') is arranged, at least in
certain sections, in the duct (7) and is axially movably guided
within the duct (7) by the guide element (4, 4'), and, by
connecting a container (2, 2') in the first connection region (3,
3'), the piercing element (5, 5') can be moved from a starting
position, in which the piercing element (5, 5') does not open the
partition wall (6), into an end position, in which the piercing
element (5, 5') opens the partition wall (6) in order to transfer a
medicinal active ingredient.
Inventors: |
Rahimy; Ismael; (Friedberg,
DE) ; Brandenburger; Torsten; (Reichelsheim,
DE) |
Assignee: |
Fresenius Kabi Deutschland
GmbH
Bad Homburg
DE
|
Family ID: |
42753422 |
Appl. No.: |
13/577007 |
Filed: |
January 10, 2011 |
PCT Filed: |
January 10, 2011 |
PCT NO: |
PCT/EP11/50229 |
371 Date: |
September 12, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61302192 |
Feb 8, 2010 |
|
|
|
Current U.S.
Class: |
141/329 ;
220/277 |
Current CPC
Class: |
A61M 5/162 20130101;
A61J 1/2051 20150501; A61J 1/1468 20150501; A61J 1/1487 20150501;
A61J 1/10 20130101; A61J 1/1481 20150501; A61J 1/201 20150501; A61M
39/221 20130101; A61J 1/1406 20130101 |
Class at
Publication: |
141/329 ;
220/277 |
International
Class: |
B65B 1/04 20060101
B65B001/04; B65D 47/36 20060101 B65D047/36 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 8, 2010 |
EP |
10152921.2 |
Claims
1.-15. (canceled)
16. A connector for containers containing medicinal active
ingredient, comprising a first connection region for the connection
of a first container, a guide element, a piercing element and a
partition wall, wherein the guide element has a duct designed for
transferring a medicinal active ingredient, the piercing element is
arranged, at least in certain sections, in the duct and is axially
moveable guided within the duct by the guide element, and, by
connecting a container in the first connection region, the piercing
element can be moved from a starting position, in which the
piercing element, does not open the partition wall, into an end
position, in which the piercing element opens the partition wall in
order to transfer a medicinal active ingredient.
17. The connector as claimed in claim 16, wherein the piercing
element projects by its end facing the first connection region
beyond the guide element.
18. The connector as claims in claim 16, wherein the piercing
element and the guide element are designed in such a way that a
clearance for transferring a medicinal active ingredient remains
between an outer face of the piercing element and an inner face,
forming the duct, or the guide element.
19. The connector as claimed in claim 16, wherein the piercing
element is designed as a solid body and/or as a hollow body.
20. The connector as claimed in claim 16, wherein the piercing
element consists at least partially, preferably completely, of a
plastic, preferably of polypropylene, polycarbonate or
polystyrene.
21. The connector as claimed in claim 16, wherein the partition
wall is arranged within the duct or at an end of the duct.
22. The connector as claimed in claim 16, wherein the partition
wall is arranged at the end of the piercing element facing away
from the first connection region.
23. The connector as claimed in claim 16, wherein the piercing
element is releasably prefixed in the starting position.
24. The connector as claimed in claim 16, wherein the guide element
has an end section which is designed to pierce and/or break open a
membrane of a container which can be connected into the first
connection region.
25. The connector as claimed in claim 24, wherein the connector is
designed such that, when connecting to the first connection region
and transferring the container into an upstream container docking
position, at first the partition wall is opened by the piercing
element, and, when transferring the container into a container end
position, the membrane of the container is opened by the guide
element.
26. The connector as claimed in claim 16, additionally comprising a
housing with a housing section, forming the first connection
region, and a housing base, wherein the guide element is connected
to the housing at the housing base.
27. The connector as claimed in claim 16, additional comprising a
second connection region for the connection of a second container,
wherein the partition wall is arranged such that in the closed
state it prevents the transport of a medicinal active ingredient
between the first connection region and the second connection
region.
28. The connector as claimed in claim 27, wherein the second region
is formed by a connecting means connected to the housing base.
29. The connector as claimed in claim 28, wherein the housing and
the connecting means are one-part, preferably integral.
30. The connector as claimed in claim 16, wherein the first
connection region is designed for the connection of a glass bottle
or as a Luer connection.
Description
TECHNICAL FIELD
[0001] The invention relates to a connector for containers
containing medicinal active ingredient, which connector makes it
possible to transfer active ingredient from one container into
another container.
PRIOR ART
[0002] EP 2 095 805 A2 discloses a connector for containers
containing medicinal active ingredient, which connector comprises a
first connection region for the connection of a glass vial, a
second connection region for the connection of a flexible bag and
an axially movable piercing element taking the form of a cannula
which is sharpened on two sides. The piercing element is mounted in
an axially displaceable manner in a first housing section of a
housing of the connector. The first housing section is mounted in a
telescopically displaceable manner on a second housing section. In
the starting position of the connector, the first housing section
and the second housing section are pulled apart. By connecting a
glass bottle in the first connection region and by exerting a
pressure on the glass bottle, the first housing section is
displaced with respect to the second housing section. A membrane
arranged in the neck of the glass bottle and closing the glass
bottle strikes one end of the piercing element. Pushing forward the
glass bottle takes along the piercing element until it strikes by
its other end against a membrane enclosing the flexible bag.
Further pushing forward of the glass bottle causes both the
membrane belonging to the flexible bag and also the membrane of the
glass bottle to be pierced by the piercing element. A limit stop
for the movement of the piercing element limits the movement of the
piercing element and ensures that not only the membrane belonging
to the bag but also the membrane of the glass bottle is opened.
[0003] A disadvantage of this connector is that it comprises parts
which are movable with the two housing sections and which have to
be sealed with respect to one another. Furthermore, the connector
comprises a large number of elements which make the production of
the connector complicated and expensive.
BRIEF DESCRIPTION OF THE INVENTION
[0004] The connector according to the invention for containers
containing medicinal active ingredient comprises a first connection
region for the connection of a first container, a guide element, a
piercing element and a partition wall, wherein the guide element
has a duct designed for transferring a medicinal active ingredient,
the piercing element is arranged, at least in certain sections, in
the duct and is axially movably guided within the duct by the guide
element, and, by connecting a container, the piercing element can
be moved from a starting position, in which the piercing element
does not open the partition wall, into an end position, in which
the piercing element opens the partition wall in order to transfer
a medicinal active ingredient.
[0005] The fact that the guide element forms both the duct through
which an active ingredient can be transferred and also forms a
mount in which the piercing element can be displaced in an axially
movable manner means that the guide element can adopt a dual
function. Consequently, the number of elements of the connector can
be reduced and the connector can be produced cost-effectively. It
is also possible in this manner to reduce the number of interfaces
and to improve the handling of the connector. The connector
according to the invention makes it possible in particular to
transfer the medicinal active ingredient without risk of
contamination.
[0006] The containers which can be connected or attached by the
connector may be both closed containers, for example glass bottles,
plastic bottles or bags, in particular flexible bags, and "open"
containers, for example catheters or other lines, as are used, for
example in infusion, transfusion, clinical nourishment, oncology,
dialysis or other medical fields. The medicinal active ingredient
which can be transferred from one container to the other container
by means of the connector may be a liquid or else a powder, for
example.
[0007] The partition wall may be a flexible partition wall, for
example consisting of an elastic material, in particular in the
form of a membrane, or else, which is preferred, a rigid partition
wall which is broken open or pierced by the piercing element.
[0008] In a preferred embodiment, the piercing element and the
guide element are designed in such a way that a clearance for
transferring a medicinal active ingredient remains between an outer
face of the piercing element and an inner face, forming the duct,
of the guide element. In an alternative embodiment, the piercing
element and the guide element are designed in such a way that the
medicinal active ingredient is additionally or exclusively
transferred by means of the piercing element. For the respective
purpose, the piercing element can be designed to be solid or as a
hollow body. A combination of hollow body and solid body is also
possible in principle. The profile of the piercing element
preferably changes along its axis, with the end section facing the
partition wall being designed to break open or pierce the partition
wall, and the end section facing the container to be connected
being designed in such a way that a pressure can be exerted on the
end section by means of the container, which pressure can be used
to press the piercing element against the partition wall. For this
purpose, the end section facing the partition wall may, for
example, be designed to taper with a linear or cross-shaped
profile, while the other end section may be designed with, for
example, a cross-shaped or round profile so as to form a bearing
surface. In the case where the piercing element is designed as a
hollow body, the end section facing the partition wall may be
designed with a faceted finish or have a swaged tip.
[0009] In a preferred embodiment, the guide element and the
partition wall are formed in one part, being integral in a
particularly preferred embodiment.
[0010] In a further preferred embodiment, the connector comprises a
housing forming the first connection region. Housing, guide element
and partition wall are preferably formed in one part, particularly
preferably integrally. The one-part and possibly integral formation
of a plurality of functional elements makes it possible to reduce
the number of parts of the connector, and the production costs can
be reduced.
[0011] In a further preferred embodiment, piercing element, guide
element, partition wall and/or housing are produced from a plastic,
preferably polypropylene (PP) or a blend of polypropylene and
styrene/ethylene-butylene/styrene (SEBS). In particular, piercing
element, guide element, partition wall and/or housing may be
injection moldings. Alternatively, the piercing element can be
produced from, for example, polycarbonate (PC) or polystyrene
(PS).
[0012] In a further preferred embodiment, the guide element
comprises an end section which is designed to pierce a membrane of
a container which can be connected into the first connection
region, for example to pierce a rubber stopper of a glass vial. The
guide element thus comprises a further function. A further element
which is intended for piercing a membrane can be dispensed with in
this manner.
[0013] In a further preferred embodiment, the first connection
region is designed as a Luer connection of a Luer lock, in
particular as a male part. In this case, the guide element is
formed partially or completely by the central cone of the Luer
connection. By connecting the female part, and on screwing the
connection, the piercing element is preferably pressed from its
starting position into the end position, in which the partition
wall is opened. The connection of the counterpart of the Luer
connection can thus be connected with an opening of the partition
wall, and an additional movement sequence can thus be dispensed
with. Moreover, the risk of contamination is reduced.
[0014] Further advantageous embodiments of the invention form the
subject matter of the dependent claims.
[0015] The invention will be explained in greater detail with
reference to exemplary embodiments, which are depicted by means of
a plurality of figures.
BRIEF DESCRIPTION OF THE FIGURES IN THE DRAWING
[0016] In the drawing:
[0017] FIG. 1 shows a longitudinal section through a first
embodiment of a connector according to the invention,
[0018] FIG. 2 shows a section through the connector shown in FIG. 1
along the section line C-C,
[0019] FIG. 3 shows a first perspective view of the connector shown
in FIG. 1,
[0020] FIG. 4 shows a second perspective view of the connector
shown in FIG. 1,
[0021] FIG. 5 shows a portion of the piercing element of the
connector shown in FIG. 1,
[0022] FIG. 6 shows a perspective view of the connector shown in
FIG. 1, cut away along the longitudinal axis, in a starting
state,
[0023] FIG. 7 shows a perspective view of the connector shown in
FIG. 1, cut away along the longitudinal axis, before connecting a
glass vial,
[0024] FIG. 8 shows a perspective view of the connector shown in
FIG. 1, cut away along the longitudinal axis, with the glass vial
in a docking position,
[0025] FIG. 9 shows a perspective view of the connector shown in
FIG. 1, cut away along the longitudinal axis, with the glass vial
in the connected end position,
[0026] FIG. 10 shows a perspective view of the first connection
region of the connector shown in FIG. 1,
[0027] FIG. 11 shows a side view of a second embodiment of a
connector according to the invention with a Luer female part
connected to the connector,
[0028] FIG. 12 shows a perspective view of the connector shown in
FIG. 11 with a Luer female part,
[0029] FIG. 13 shows a plan view of the connector shown in FIG.
11,
[0030] FIG. 14 shows a longitudinal section through the connector
shown in FIG. 11 with a Luer female part,
[0031] FIG. 15 shows an enlarged representation of the detail A
depicted in FIG. 14,
[0032] FIG. 16 shows a perspective view of the connector shown in
FIG. 11, cut away along the longitudinal axis, before connecting
the Luer female part,
[0033] FIG. 17 shows a perspective view of the connector shown in
FIG. 11, cut away along the longitudinal axis, with a connected
Luer female part, and
[0034] FIG. 18 shows a perspective view of the piercing element of
the connector shown in FIG. 11.
DESCRIPTION OF THE TYPES OF EMBODIMENT
[0035] FIGS. 1 to 10 show various views of a first embodiment of a
connector 1 according to the invention for containers containing
medicinal active ingredient.
[0036] The connector 1 comprises a first connection region 3 for
the connection of a first container, a guide element 4, a piercing
element 5, a partition wall 6 and a second connection region for
the connection of a second container. The first connection region 3
is designed here for the connection of a medicinal glass vial. The
second connection region 12 is designed here for the connection of
a flexible bag. Alternatively, the first connection region 3 and/or
the second connection region 12 can of course also be designed for
other containers, for example plastic bottles or transfer
systems.
[0037] The connector 1 comprises a housing 9 with a substantially
hollow-cylindrically shaped housing section 10, forming the first
connection region 3, and a housing base 11. The guide element 4 is
designed as a tubular hollow body with a duct 7 for the transfer of
a medicinal active ingredient and is connected to the housing base
11 in the center of the housing base 11. One end of the guide
element ends at the housing base 11, while the other end projects
into the connection region 3 and thus into the inner region of the
housing section 3. The end section 8 of the guide element 4 that
projects into the connection region 3 is sharpened or pointed in
order to pierce through a membrane 14 of a container 2 to be
connected in the connection region 3. The housing section 10 and
guide element 4 are arranged axially in a common axis of symmetry
15.
[0038] Furthermore, the connector 1 comprises a connecting means 13
which forms the second connection region 12. The connecting means
13 is of tubular design, arranged along the axis of symmetry 15 and
is connected by one end to the rear side of the housing base 11
situated opposite to the connection region 3. At the other end, the
connecting means 13 comprises two welding lugs 16 formed with
mirror-image symmetry for connecting the connecting means to a
flexible plastic bag which is not represented in further detail.
Furthermore, the connecting means 13 comprises two reinforcing webs
17 extending laterally along the axis of symmetry 15, these webs
extending from the base 11 as far as the welding lugs 16 with
mirror-image symmetry and having the purpose of reinforcing the
connecting means.
[0039] The partition wall 6 takes the form of a membrane. It is
arranged between the first connection region 3 and the second
connection region 12 and, in the closed state, prevents the
transport of a medicinal active ingredient between these two
regions. Specifically, the partition wall 6 is arranged at the end
of the guide element 4 facing away from the first connection region
3 and terminates flush with the rear side of the housing base 11.
Alternatively, instead of an arrangement of the partition wall 6 at
an end of the duct 7, an arrangement of the partition wall 6 within
the duct 7 of the guide element 4 is also possible. Furthermore,
the partition wall 6 can be arranged such that it is raised from
the housing base 11, for example is arranged in the manner of a
cover on the opening of the duct 7. Furthermore, the partition wall
6 can be fastened to the housing base 11 via at least one
predetermined breaking point, with the result that the partition
wall can be broken open at the at least one predetermined breaking
point by the piercing element 5, and the duct 7 is opened in this
way. In this case, piercing of the partition wall 6 can be
dispensed with.
[0040] The partition wall 6 is designed as a wall with a
sufficiently thin wall thickness so that it can be pierced and/or
broken open by the piercing element 5. In this embodiment, the
partition wall is designed in such a way that, after the
piercing/breaking-open operation, it remains opened upon a
withdrawal of the piercing element 5, which is preferred. It is
also possible to design the partition wall 6 in such a way that it
can close after a withdrawal of the piercing element 5.
[0041] In this exemplary embodiment, the housing 9, guide element
4, partition wall 6 and connecting means 12 are produced in one
part and integrally from plastic, here from PP or a blend of PP and
SEBS, as an injection molding, with the result that the connector
can be produced in a particularly cost-effective manner. Also
possible in principle is a multi-part construction and/or a
construction composed of a plurality of different materials.
[0042] In this embodiment, the piercing element 5 is designed as a
solid rod. The piercing element is arranged in the duct 7 and is
axially movably guided within the duct 7 by the guide element 4.
Between the inner face of the duct 7 and the outer face of the
piercing element 5 there is an axially extending clearance which
has a sufficient cross section in order to allow medicinal active
ingredient to pass through sufficiently quickly between the first
connection region 3 and the second connection region 12. Here, the
piercing element 5 has a cross-shaped profile which is adapted in
its outer dimensions to the inner diameter of the tubular guide
element 4, with the result that the piercing element 5 does not
tilt. Other profiles can also be used for the piercing element 5,
for example profiles with a triangular shape, star shape, square
shape and/or cylinder shape. The piercing element 5 can also be
designed partially or completely as a hollow body and the transport
of the medicinal active ingredient can take place partially or
completely through the piercing element 5. Alternatively, the guide
element 4 can also be designed with other profiles, for example a
square or rectangular profile.
[0043] Furthermore, the piercing element 5 is releasably prefixed
in a starting position in which the piercing element 5 does not
open the partition wall 6. For this purpose, the piercing element 5
comprises two mutually opposite projections 18 which, in the
starting position, releasably engage in two corresponding grooves
19 in the guide element 4. By means of sufficient pressure on the
piercing element 5, as can be exerted for example when connecting a
glass bottle in the first connection region 3, the piercing element
can be released from the starting position and transferred into an
end position. When transferring the piercing element 4 from the
starting position into the end position, the piercing element 4
opens the partition wall 6; see also FIGS. 6 to 9. The guide
element 5 has two further grooves 20 into which the piercing
element 4 can latch after opening the partition wall 6 and which
prevent the unwanted release of the piercing element 4 from the
guide element 4. Alternatively, the piercing element 4 can be
provided for example with only one groove or further grooves, and
in the case of a plurality of grooves they can be arranged in an
offset manner for example. As a further alternative, the piercing
element can be prefixed in the guide element by means of an
oversize for example.
[0044] To make it easier to break open or pierce the partition
wall, the piercing element 5 is sharpened or pointed at its end
facing the partition wall 6. At its other end facing away from the
partition wall 6, the piercing element 5 forms a bearing face in
order to take up the pressure over as large an area as possible of
a container to be connected and to prevent the piercing element 5
from unwantedly penetrating into the container, for example
piercing a rubber stopper closure of the container. For this
purpose, the end of the piercing element 5 facing away from the
partition wall is designed in this case as a planar face.
[0045] In this exemplary embodiment, the piercing element 5 is
produced in one part and integrally from a plastic, preferably from
PP, PC or PS, as an injection molding. Alternatively, the piercing
element 5 can also be multi-part and/or consist of other materials,
for example also of a metal, and/or of a plurality of
materials.
[0046] Furthermore, the connector comprises a removable cover foil
21 which closes the first connection region 3 and protects it from
contamination, for example from contamination by means of
unintentional contact. The cover foil may, for example, be a
manually removable aluminum foil or plastic film.
[0047] FIGS. 6 to 9 show the connection of a glass vial 2 to the
connector 1.
[0048] FIG. 6 shows the connector 1 in the starting state. To
connect a glass bottle 2, first of all the cover foil 21 is
manually removed. Then, the glass bottle is inserted by its neck
into the first connection region 3; see FIG. 7. On inserting the
glass bottle 2, the glass bottle 2 exerts an axial pressure on the
piercing element 5 on the end of the piercing element 5 projecting
beyond the guide element 4 and facing the glass bottle 2, which
pressure presses the piercing element 5 by its end facing the
partition wall 6 against the partition wall until the piercing
element 5 has broken through the partition wall 6 as a result of
the pressure. Further insertion of the container 2 causes the
piercing element 5 to be axially displaced until the container 2
has reached an upstream container docking position; see FIG. 8. The
housing 9 comprises a plurality of axially extending clamping webs
22 which extend on the inner side of the housing section 10 and
which connect the glass bottle to the connector 1 by clamping when
it is inserted into the connection region. In the container docking
position, the membrane 14, here a rubber stopper, arranged in the
neck of the container 2 is not yet pierced, such that in this
position any transfer of a medicinal active ingredient is still
prevented. In particular, the container 2 can be released from the
connector 1 without it having already been opened. The latter is
particularly advantageous when the container 2 contains expensive
active ingredients.
[0049] On further inserting the container 2 into the connection
region 3, the membrane 14 is pierced by the cannula-like end
section 8 of the guide element 4; see FIG. 9. An active ingredient,
for example a liquid or a powder, situated in the container 2 can
now be transferred by means of the connector 1 and for example
diluted and/or dissolved, for example in a flexible bag connected
to the connecting means 13, or, conversely, an active ingredient
can be passed into the container 2. On further inserting the
container 2, the container 2 reaches an end position in which one
or more projections 23 on the inner side of the housing section 10,
see for example FIG. 8, positively engage behind the container 2 at
its neck and prevent the container 2 from slipping out of the first
connection region 3 of the connector 1. The connection region 3 can
be provided with a further undercut, for example by means of
additional projections, which already fixes the container 2 in the
docking position with the formation of a positive fit. The clamping
webs 22 can also be present in this variant; alternatively,
however, they can also be dispensed with. Such a second undercut
facilitates the connection of containers having different
dimensions to the connector 1.
[0050] The container 2 can be premounted on the connector in the
docking position. The premounted container 2, the connector 1 and a
container, in particular a bag, connected to the connector 1 can be
enclosed as a set in an outer bag. This makes it possible to
reliably mix the components outside the laminar flow region without
the risk of contamination.
[0051] FIGS. 11 to 18 show a second embodiment of a connector 1'
according to the invention for containers containing medicinal
active ingredient, in various views. Elements or components which
correspond to those of the first embodiment have been designated
with the same reference signs which were used to designate the
components of the first embodiment.
[0052] The connector 1' according to the second embodiment
comprises a first connection region 3', a guide element 4', a
piercing element 5', a partition wall 6 and a second connection
region 12. The second connection region 12 is formed by a
connecting means 13 which corresponds to that of the first
embodiment. As a departure from the first embodiment, the first
connection region 3' is designed as a Luer connection of a Luer
lock (ISO 594/1), here as a Luer male part. Connection region 3',
guide element 4', piercing element 5' and connecting means 13 are
arranged along the common axis of symmetry 15.
[0053] The connector 1' comprises a housing 9' having a
substantially cylindrical housing section 10' with an inner thread
and a housing base 11' which form the connection region 3'. The
guide element 4' is designed as a hollow outer cone and projects
into the connection region 3'. By being designed as a hollow body,
the guide element 4' comprises an internal duct 7 which is provided
for the transfer of a medicinal active ingredient. The guide
element 4' is connected to the housing base 11' in the center of
the housing base 11'.
[0054] The partition wall 6 is arranged in the plane of the housing
base 11' in a corresponding manner to the partition wall 6
according to the first embodiment and correspondingly designed. In
the closed state, the partition wall 6 prevents any transport of a
medicinal active ingredient between the first connection region 3'
and the second connection region 12.
[0055] The processing element 5' is designed to be tubular as a
hollow body. The piercing element 5' is arranged in certain
sections in the duct 7 and is axially movably guided within the
duct 7 by the guide element 4'. In the guided section, the outer
diameter of the piercing element 5' is tailored to the inner
diameter of the guide element 4' to obtain optimally play-free
mounting. At its end facing the first connection region 3', the
piercing element 5' has a collar 24, see FIG. 5, while at its end
facing away from the first connection region 3', the piercing
element 5' is sharpened or pointed in order to cut more easily
through the partition wall 6. In a starting position, in which the
piercing element 5' does not open the partition wall 6, see FIG.
16, the collar 24 is spaced from the guide element 4', while in an
end position, in which the piercing element 5' opens the partition
wall 6 in order to transfer a medicinal active ingredient, the
collar 24 rests on the upper edge 25 of the guide element 4', see
FIGS. 15 and 17, with the result that a further insertion of the
piercing element 5' into the guide element 4' is blocked.
Alternatively, the piercing element 5' can also be designed as a
solid body, for example with a cross-shaped, star-shaped,
triangular or similar profile. In this case, a clearance remaining
between the inner face of the guide element 4' and the outer face
of the piercing element 5' can be used for the transport of the
medicinal active ingredient.
[0056] In this exemplary embodiment, housing 9', guide element 4',
partition wall 6 and connecting means 6 are produced as a one-part
and integral injection molding from a plastic, preferably PP or a
PP-SEBS blend. It would also be possible in principle to have a
multi-part construction and to use other and/or different
materials. The piercing element 5' is likewise a one-part and
integral injection molding made of plastic, preferably PP, PC or
PS. As an alternative, it would also be possible here in principle
to have a multi-part construction and to use other and/or different
materials.
[0057] In addition to the connector 1', the depicted figures show
an element of a container, here a Luer female part 2', which is
connected or has been connected to the connector 1'. The Luer
female part 2' can be a constituent part of a syringe or a transfer
system, for example.
[0058] FIG. 16 shows the state after attaching the Luer female part
2' and before locking the Luer female part 2' with the Luer male
part of the connector 1'. In this position, the guide element 4'
together with the projecting piercing element 5' is already
partially inserted into the inner cone of the Luer female part 2'.
The outer diameter of the collar 24 of the piercing element 5' is
tailored to the diameter of the inner cone of the Luer female part
2' such that the collar 24 cannot be plugged completely through the
inner cone, but is clamped in at its outer edge beforehand by the
tapering inner cone, here virtually at the end of the inner cone.
When locking the Luer female part 2' with the male part, which is
formed by the housing 9', the Luer female part 2' is displaced
axially in the direction of the connector 1'. During this movement,
the piercing element 5' clamped at the collar 24 is taken along by
the female part 2', and the partition wall 6 is broken open or
pierced and opened by the sharpened or pointed end of the piercing
element 5', see FIG. 17. The connection between the first
connection region 3' and the second connection region 12 is now
opened, thereby allowing the transport of a medicinal active
ingredient between a flexible bag connected to the connector 1' in
the connection region 12 or another container with a container
connected by the Luer female part 2'.
[0059] To protect against contamination and/or to protect against
unwanted opening of the partition wall 6 by a movement of the
piercing element 5', the connection region 3' of the connector 1'
with piercing element 5' can be covered by a manually removable cap
(not shown). Furthermore, the piercing element 5' is preferably
prefixed in its extended starting position, for example by means of
a tongue-and-groove connection in a similar manner to that of the
first embodiment. It is also possible to fix the piercing element
5' in the end position, for example in order to prevent the
piercing element 5' from falling out when releasing the female
part
[0060] The connectors 1, 1' according to the invention have the
advantage that they can be produced cost-effectively. Furthermore,
a sterile connection between two containers can be produced
manually in a simple manner both reliably and quickly. In order to
quickly transfer a medicinal active ingredient, guide element 4, 4'
and piercing element 5, 5' can be designed with suitable
profiles.
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