Note: Descriptions are shown in the official language in which they were submitted.
WO 2020/183331
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CONNECTION ASSEMBLY FOR DIRECTING A MEDICAL LIQUID
CROSS-REFERENCE TO RELATED APPLICATION
100011 This application claims priority to US. Patent Application No.
16/296,643,
filed March 8, 2019, which is a continuation-in-part of U.S. Patent
Application No.
15/821,724, filed November 22, 2017, which is a continuation of International
Patent
Application PCT/EP2016/061582, filed May 23, 2016, which claims priority to
foreign
European Patent Application No. EP 15168952.8, filed May 22, 2015, the
disclosures of
which are each incorporated herein by reference as if set forth in their
entireties herein.
TECHNICAL FIELD
100021 This disclosure relates to a connection assembly configured to deliver
a liquid.
In particular, the present disclosure relates to a connection assembly
including a deformable
sealing element for providing needle-free access to the container.
BACKGROUND
100031 In the medical field, liquids can often be stored in containers such as
flexible bags, ampules, or bottles before being supplied to a patient.
Connection
assemblies, or connectors, can be used to direct the liquid into the container
or remove the
liquid from the container.
100041 Such connectors are used, for example, to create so-called needle-free
acress to
a container that holds liquid in order to fill the container with liquid or
remove liquid from the
container via the access. Such needle-free access provides entry to the
container using a
delivery device that has no injection needle. Instead, a connecting piece for
a delivery device in
the form of a syringe, for example, is incorporated into a slot opening of a
sealing element in
older to open the slot opening in this manner and allow flow between the
delivery device and
the container. By using needle-free access, the risk of injury in particular,
which would otherwise
be present when using injection needles, can be reduced.
100051 Connectors are also important in container sterilization. Even if the
sealing
element provided is already sterile, legal requirements can make it necessary
to wipe or
dab off the outside of the delivery device before attaching the delivery
device to the
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attachment member. This should ensure access to a container, for example,
under sterile
conditions.
[0006] The object of the present invention is to provide a connection assembly
to
guide a liquid which is reliably secured but which also allows a certain
mobility of the
sealing element. The flow, in particular should not be significantly affected
by this.
Another object of the present invention comprises a connection assembly in
which the
wiping or dabbing off of the sealing element for the purpose of disinfection
is made
possible. A further object of the present invention is to provide a connection
assembly
allowing needle-free container access.
SUMMARY
[0007] The present disclosure relates to a connection assembly for directing a
liquid.
The connection assembly includes a connector through which a liquid is
delivered and an
attachment member attached to a connector which can be connected to a delivery
device for
delivering a liquid through the connector. The attachment piece can have an
opening that
engages with the connector when the attachment member is attached to the
connector. The
connection assembly also includes a sealing element for sealing the transition
between the
connector and the attachment member. The sealing element can be inserted into
the opening
of the attachment member in an insertion direction in such a manner that the
sealing element
is held on the attachment member and is attached to the connector between the
attachment
member and the connector. In particular, the interior of the sealing element
can be free of any
body having a point that is intended to support the opening of the sealing
element.
[0008] The sealing element has a sealing head that seals off the opening of
the
attachment member from liquid passage when the attachment member is attached
to the
connector. The sealing element also has a body adjoining the sealing head that
can be
spaced a radial distance from the attachment member when the sealing element
is attached
to the attachment member and the connector. The sealing element can further
have a
shoulder at the transition between the sealing head and the body that projects
radially with
respect to the insertion direction through the sealing head and along the
insertion direction_
This shoulder can be brought into contact with a contact surface inside the
opening of the
attachment member.
[0009] Also, the sealing element can have a flange that protrudes along the
insertion direction and extends radially outward away from the body of the
sealing element
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a distance greater than that of the shoulder. The flange can be held or
clamped between the
attachment member and the connector when the attachment member is attached to
the
connector,
[0010] The sealing element is held between the attachment member and the
connector when the attachment member is attached to the connector in such a
manner that the
flange of the sealing element rests with its lower side on a contact surface
of the connector
and its upper side at least partially exposed. The sealing element has a foot
section which,
when viewed in an axial direction along an insertion direction, extends from
the body below
the flange and engages a recess defined by the connector. The sealing element
is thus held
between the attachment member and the connector in a clamping manner when the
attachment
member is attached to the connector so that a transition between the
attachment member and the
connector is sealed in a liquid-tight manner. The shoulder of the sealing
element surrounds an
insertion assembly and protrudes radially towards the outside past the sealing
head and - when
the attachment member is attached to the connector - rests on an associated
support surface of
the attachment member. The sealing element is thus supported by the shoulder
axially along the
insertion direction so that the sealing element is axially fixed relative to
the attarlunent member.
The diameter of the sealing element in the area of the shoulder can be within
a range of 4 mm to
mm, or 6 mm to 8 mm. Since the sealing element is supported on one side by the
shoulder
and on the other by its flange and the foot section, a defined, secured
placement of the sealing
element within the opening of the attachment member can be guaranteed.
[0011] The body of the sealing element can be cylindrically formed. The
sealing
element as a whole can have a preferably rotationally symmetrical form, where
different
sections of the sealing element can have different diameters. The body of the
sealing element,
which connects to the shoulder, can be arranged with radial play in the
opening of the
attachment member so that a space can be defined inside the opening of the
attachment
member between the sealing element and the attachment member. This space can
allow the
sealing element to be deformed if a delivery device is attached to the
attachment member.
Because a space is defined in which the sealing element can be pushed aside if
a delivery
device, such as a syringe with a connector, is connected to the sealing
element, a slot opening
defined through the sealing head of the sealing element can be reliably
opened_ Accordingly,
unhindered flow through the sealing element between the delivery device and
the connector
becomes possible when the slot opening is in an opened state.
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100121 The flange that protrudes radially from the sealing element connects to
the
body of the sealing element. When the attachment member is attached to the
connector, the
flange of the sealing element is fixed or held in a clamping manner between
the attachment
member and the connector. However, the flange itself is not clamped. This
indirect clamped
mounting of the flange is accomplished by the fact that the sealing element is
supported by
contact between the flange and/or foot section of the sealing element and the
connector on a
lower side and by contact between the shoulder of the sealing element and the
attachment
member on an upper side. The flange thus can rest with only its lower side on
a contact
surface of the connector and its upper side partially or completely exposed.
The sealing
element is thus fixed between the attachment member and the connector via the
flange, where
the flange can be located at the end of the body opposite the shoulder. The
diameter of the
flange of the sealing element can be greater than the shoulder. The diameter
of the flange can
be within a range of 5 mm to 11 min, or 7 nun to 9 nun. Since the flange
itself is not directly
clamped, the sealing element thus retains a certain flexibility. As a result,
the sealing head
can first be pushed down into the sealing element by the syringe connector of
the syringe
when the syringe is connected to the connector, thus causing the side wall of
the sealing
element to radially deflect. The sealing element can then be opened when the
connector
presses the syringe into a slot opening that extends through the sealing head.
In particular, the
radial compensation movement of the side wall can be supported by the movable
arrangement of the flange. Preferably this can be also supported by the
thickness of the side
wall. The side wall above the shoulder can, in particular at least partially,
have a thickness
within a range of 0.6 nun to 1.5 nun, and more particularly from 0.8 mm to 1.2
min. The side
wall in the shoulder region can have a thickness within a range of 1.5 mm to
2.2 mm, and
more particularly from 1.7 nun to 2.0 mm. The thickness of the side wall below
the shoulder
and above the flange is greater than the thickness of the side wall above the
shoulder. The
side wall below the shoulder and above the flange can, at least partially,
have a thickness
within a range of!.! mm to 2.0 nun, and more particularly from 1.4 mm to 1.8
mm.
100131 In one embodiment, a radial outer section of the flange can initially
be held in a
clamping manner when the attachment member is attached to the connector. In
particular, the
flange can be disposed between a contact surface of the connector and a
projection of the
attachment member that protrudes radially inwards into the opening of the
attachment member.
In one embodiment, the projection of the attachment member can be an annular
projection. The
annular projection can extend fully or only partially over the periphery of
the sealing element.
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The sealing element can thus be placed within the annular projection, for
example completely
inside the opening, where the annular projection of the body projects radially
inward into the
opening and can be held at a radial distance from the outer walls of the
attachment member that
surrounds the opening. The annular projection can thus cause a partially
clamped fixing of the
sealing element between the attachment member and the connector. In addition,
the annular
projection can support the centered placement of the sealing element inside
the opening with a
iadial distance between the sealing element and the walls of the attachment
member that
surround the sealing element. In a further embodiment, the connection between
the connector
and the attachment member can also be provided by the annular projection.
100141 The sealing element can be formed with a convex outer side that faces
away
from the connector when the attachment member is attached to the connector.
Alternatively, the outer side of the sealing element can be substantially flat
or curved
concavely inwards. The outer side can in particular be in a state in which a
delivery device can
be connected to a portion of the attachment member projecting outward from the
attachment
member or flush with a surface of the attachment member so that, before
attachment of the
delivery device occurs, the outer side of the sealing element can be easily
accessed from the
outside and wiped or dabbed off in order to sterilize it. The attachment
member in this case can
have a detachable part that is integrally associated with another section of
the attachment
member connected to the connector in an initial state. The detachable portion
of the attachment
member can be separated from this section, in particular broken off, to
connect a delivery
device to the attaclunent member. When the detachable part is removed from the
rest of the
attachment member, the outer side of the sealing element can protrude upwards
so that the outer
side can be wiped or dabbed off from the outside. The connection assembly, and
in particular
also the outer side of the sealing element, can be provided in a sterile
condition even in its
initial state before breaking off the detachable part. The outer side of the
sealing element is
formed on the sealing head of the sealing element. If, for example, a
detachable part is
removed from the attachment member, essentially only the outer side of the
sealing element
is exposed and projects, for example, outwardly in a convexly curved manner
and can be
wiped or dabbed off in a simple, reliable rammer. The upper or outer side of
the sealing head
can have a diameter within a range of 3 mm to 7 nun, or from 4 mm to 6 nun.
The sealing
head can have a thickness within a range of 0.9 mm to 1.8 mm, and more
particularly from
1.1 mm to 1.5 mm. This can support a reliable sealing and opening function.
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100151 The shoulder of the sealing element is preferably located on an end of
the
sealing head facing away from the outer side. In the case of the connector
according to the
invention, no hollow body having a point intended to support the opening of
the membrane is
provided. No body or hollow body having a point is provided that is arranged
in the interior
of the sealing element and intended to support the opening of the sealing
head.
100161 According to a further embodiment, a preferably cylindrical section
when
viewed axially in the insertion direction joins to the sealing head and merges
into the shoulder
which projects radially outward over the cylindrical section. This cylindrical
section preferably
has a larger diameter than that of the sealing head. The cylindrically formed
body can further
join to the shoulder, again seen axially along the insertion direction, where
the shoulder
protrudes radially outward over the body. In addition, the body can have a
recess in its outer
side at a transition to the flange, which can be provided by means of or as a
step. In one
embodiment, there is only a single step in the body of the sealing element.
With this, the radial
compensating movement of the sealing element when the syringe is connected is
supported, for
example, by a kind of bulge. In cross-section, the recess can have an
essentially flat bottom. The
recess can, for example, have a quadrangular cross section. In this case, the
base and the radial
opening of the recess can have essentially the same dimensions.
100171 A foot section of the sealing element, which protrudes from the flange
in the
insertion direction when viewed axially along the insertion direction, can
extend from the
flange and engage an associated recess defmed by the connector when the
attachment
member is attached to the connector. An advantageous connection between the
sealing
element and the connector is thus created at a defined position of the sealing
element within
the opening of the attachment member. The sealing element can thus be
supported by its
shoulder on one side of the body and by its flange and/or foot section on the
other side. The
sealing element can have a total height within a range of 6 ntrn to 15 mm, or
within a range of
9 mm to 12 mm. The foot section can have a height within a range of 0.7 mm to
1.6 mm, and
more particularly within a range of 1.0 mm to 1.3 mm. The foot section can
have a decreasing
wall thickness in direction to the lower end of the sealing element. The wall
thickness of the
foot section can decrease from a range of 1.1 mm to 1.5 nun to a range of 0.6
mm to 1.0 min.
This can support safe positioning within the connector and/or the movable
arrangement of the
flange.
100181 The sealing element can have a slot opening defined by the sealing head
which, when the attachment member is attached to the connector, can be closed
off from
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liquid pascage therethrough. By joining the delivery device to the attachment
member, the
slot opening can be opened in such a way that a liquid can be conveyed through
the slot
opening. By using such a slot opening, needle-free access is created through
the sealing
element, by means of which, for example, a container connected to the
connector can be
accessed when using a delivery device which has no hypodermic needle.
[0019] The delivery device can, for example, be fitted with a connector
configured
to engage the sealing element for the purpose or providing needle-free access
through the
sealing element. The connector, through the application of pressure on the
sealing element,
can shift the upper side of the sealing element down and be pressed into the
slot opening,
which opens the sealing element to create a flow path for liquid. The delivery
device then
extends itself when it is fully attached ¨ for example, screwed on tight,
preferably to the
connector through the slot opening of the sealing element ¨ so that there can
be an
unhindered flow between the delivery device and the container through the
sealing
element. In one embodiment, at least 80%, or at least 90%, of the opening
cross section in
the delivery device through which the liquid is transported is exposed and is
thus not
covered by the sealing element. In another embodiment, the whole cross section
of the
opening in the delivery device through which the liquid is transported can be
exposed.
[0020] The attaclunent member can be formed in a single piece as a plastic
molded
part. In one embodiment, the attachment member is injection-molded, though
other
manufacturing methods are contemplated. The attachment member according to the
present
disclosure has a first section and a detachable part. The opening in which the
connector engages
the attachment member can be formed in the first section. In an initial state
of the attachment
member, the detachable part is joined to the first section. The detachable
section can be
removed, in particular broken off, from the first section in order to connect
a delivery device to
the attachment member. The sealing element is held on the first section and
seals off the
opening of the first section from the outside when the detachable part is
broken off. The outer
side of the sealing element, in this case, faces towards the outside and can
project through the
first section towards the outside. Alternatively, the outer side of the
sealing element is flush
with the first section. In one embodiment, the attachment member provides a
female Luer
fitting, though other fittings are contemplated.
[0021] In one specific embodiment, the first section of the attachment member
is
formed by a connection section that can be attached to the connector, as well
as a threaded
portion connecting to the connection section. The threaded portion can have at
least half
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threading for enabling a threaded connection with the delivery device. The
threaded
connection can further be provided by double threads. In this manner, a so-
called Luer-lock
connection is provided, by which a connection element in the form of a union
nut can be
connected to a delivery device, for example a Luer-lock syringe, to create a
Luer-lock
connection. In its initial state, the detachable part is connected to the
threaded portion, and
in this manner seals off the attachment member from the outside. To connect
the delivery
device to the attachment member, the detachable part of the attachment member
can be
removed from the threaded section (broken off, for example), so that the
delivery device
can be brought into connection in a screwing manner with the threaded portion
via its
connection element
100221 The threaded portion and the detachable part can be integrally formed
such
that they are integral in the initial state and together define a single
piece. Between the
threaded portion and the detachable part, a predetermined breaking point can
be provided. In
one embodiment, the predetermined breaking point takes the form of a
circumferential
notched recess, which can enable the defined removal of the detachable part
from the
threaded portion along a line specified by the predetennined breaking point.
[0023] The sealing element can be situated with its sealing head in an
engagement
opening of the threaded portion so that essentially only the outer side of the
sealing head is
accessible from the outside. If the outer side projects over the threaded
portion towards the
outside or terminates flush with the upper side of the threaded portion, the
outside of the
sealing element can be advantageously wiped or dabbed off from the outside in
order to
attach a delivery device to the attachment member and connect it to the
connector under
sterile conditions.
[0024] A head of the connector can be configured to be disposed in the opening
of
the attachment member when the attachment member is attached to the connector.
In this
case, the connector can be joined by a positive-lock connection to the
attachment member in
which, for example, a circumferential positive-lock element, such as a
circumferential
annular projection on the head of the connector, engages with an associated
positive-lock
element on the attachment member. In this manner, the connector can be axially
secured to
the attachment member. In addition, one or more positive-lock elements can be
provided on
the head of the connector to create a rotationally stable attachment of the
attachment member
to the head. To do this, for example, one or more webs extending parallel to
the insertion
direction and/or several grooves parallel to the insertion direction can be
provided on the
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head of the connector to which the complementary positive-lock elements on the
attachment
member engage when the attachment member is attached to the connector. As
such, the
attachment member can be fixed by this engagement in a rotationally stable
manner to the
connector.
[0025] In one embodiment, the connection assembly and/or the sealing element
can
be components of a container for liquids. In this case, the connector is
connected to the
container and provides access to the container. By using an attachment member
that can be
attached to the connector and/or integrated into the connector, which can
include the
sealing element, a delivery device can be connected to the connector in order
to convey a
liquid into a container or out of the container.
[0026] A sealing element for an embodiment of the connection assembly
described
above and/or the connector described above is also within the scope of the
invention. The
sealing element can include a sealing head and a body connected to the sealing
head, where
the sealing element has a shoulder which projects radially over the sealing
head with respect
to the insertion direction and can be configured to be brought into contact
with an associated
support surface inside the opening of a connector in the insertion direction.
The sealing
element can also include a flange that projects radially outward and is spaced
a distance from
the shoulder along the insertion direction. The flange and can be held in a
clamping manner
with the connector on a side facing away from the body of the sealing element.
The flange
can lie with its lower side lying on a head of the connector and its upper
side at least partially
exposed. In addition, a foot section which, viewed in an axial direction along
the insertion
direction, connects to the body underneath the flange, can engage an
associated recess
defined by the head of the connector when the attachment member is connected
to the
connector.
[0027] Also within the scope of the invention is an arrangement that includes
an
embodiment of the connection assembly described above or an embodiment of the
sealing
element described above that has a connector to attach to an attachment
member, where a
delivery device attached to the attachment member of the connector penetrates
the slot
opening of the sealing element.
[0028] The connection assembly can alternatively be a component of a connector
to
which medical lines can be connected. For example, the connection assembly can
be a
component of a so-called y-connector, to which two lines and, through the
attachment
member, also a delivery device can be connected.
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100291 An embodiment of the present disclosure is sealing element configured
to be
received between a connector and an attachment member. The sealing element
includes a
foot section configured to be received by a recess of the connector, a
shoulder configured to
engage an inner surface of the attachment member, and a flange configured to
engage a
support surface of the connector. The sealing element also includes a
cylindrical body
extending from the shoulder to the flange along an insertion direction and
configured to
deform to create a flow path through the sealing element, and a sealing head
defining an
opening that is configured to transition from a closed state to an open state
when the
cylindrical body deforms.
[0030] Another embodiment of the present disclosure is a connection assembly
configured to deliver a liquid from a delivery device to a container. The
connection assembly
includes a connector having a head that defines a recess and a support
surface, wherein the
connector is configured to connect to the container, and an attachment member
comprising an
inner surface, a lumen, a first end configured to be connected to the delivery
device, and a
second end connected to the connector. The connection assembly also includes a
sealing
element disposed in the lumen between the connector and the attachment member,
where the
sealing element includes a foot section configured to be received by the
recess of the
connector, a shoulder configured to engage the inner surface of the attachment
member, and a
flange configured to engage the support surface of the connector. The sealing
element also
includes a cylindrical body extending from the shoulder to the flange along an
insertion
direction and configured to deform to create a flow path through the sealing
element, and a
sealing head defining an opening that is configured to transition from a
closed state to an
open state when the cylindrical body deforms.
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] The idea underlying the invention is clarified below on the basis of
the
exemplary embodiment described in the figures. Shown are:
[0032] FIG. 1 is a front view of an upper portion of a container in the form
of a bag
with connectors arranged on it to which attaclunent members are attached
according to an
embodiment of the present disclosure;
[0033] FIG. 2 is an exploded view of the connector and the attachment members
shown in FIG. 1, with sealing elements arranged therebetween;
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[0034] FIG. 3a perspective view of a connector shown in FIG. 1, with an
attachment
member attached;
[0035] FIG. 41s a front view of the connector and attachment member shown in
FIG.
3;
[0036] FIG. 5 is a cross-sectional view of the connector and attachment member
shown in FIG. 3;
[0037] FIG. 61s a front view of the attachment member shown in FIG. 3;
[0038] FIG. 7 is a front view of a sealing element according to an embodiment
of the
present disclosure;
[0039] FIG. 8A is a front view of the connector shown in FIG. 3;
[0040] Fig. 8B is a side view of the connector shown in FIG. 8A;
[0041] FIG. 91s a perspective view of an attachment member shown in FIG. 3 on
the
connector, with the detachable part broken off;
[0042] FIG. 10 is a perspective view of the attachment member shown in FIG. 3,
with
the detachable part broken off;
[0043] FIG. 11 is the sectional view according to FIG. 5, with the detachable
part of
the attachment member broken off;
[0044] FIG. 12A is a side view of a delivery device and a connector according
to an
embodiment of the present disclosure;
[0045] FIG. 12B a cross-sectional view of the delivery device shown in FIG.
12A
connected to the connector;
[0046] FIG. 13 a view of a connection assembly according to an embodiment of
the
present disclosure;
[0047] FIG. 14 is an exploded view of the connection assembly shown in FIG.
13;
[0048] FIG. 15 is an a side view of a sealing element according to another
embodiment of the present disclosure;
[0049] FIG. 16 is a side cross-sectional view of the sealing element shown in
FIG.
15; and
[0050] FIG. 17 is a cross-sectional view of a connection assembly
incorporating the
sealing element shown in FIG. 16.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
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[0051] Referring to FIG. 1, a container 1 is shown. Though the container 1
depicted
takes the form of a flexible bag, other types of containers are contemplated,
such as ampules
or bottles. The container 1 comprises a bag body 10 for receiving a liquid,
for example a
medicine, a saline solution, a nutrient solution, or the like. The liquid can
be stored in
container 1, where liquid can be filled into the container 1 or removed from
the container 1
via first and second connectors 11, 12.
[0052] First and second connectors 11, 12 provide access to the container 1
for
adding or removing the liquid from the container 1. In the illustrated
exemplary embodiment,
the first connector 11, is designed to allow, together with attaclunent member
2, connection
of delivery device 5 in the form of a syringe (shown in greater detail in
FIGS. 12A and 12B),
so that a liquid component can be delivered into the container 1 via the first
connector 11.
The second connector 12, however, together with attachment member 3, provides
an access
by which an infusion set, for example, can be connected to the container 1 in
order to supply
a liquid from the container 1 to a patient.
[0053] FIG. 2 shows an exploded view of the connection assemblies formed by
first
and second connectors 11, 12, attachment members 2, 3 and associated sealing
elements 4, 6,
where the sealing element 4 is disposed between the first connector 11 and the
attachment
member 2, and the sealing element 6 is disposed between the second connector
12 and the
attachment member 3. During formation of the container 1, the first and second
connectors
11, 12 are to be placed between sheets to create the container 1 and are
welded to the sheets
so that connectors 11, 12 are integrally bonded to the sheets. Attachment
members 2, 3 are
then attached to the first and second connectors 11, 12 to complete the
container 1, so that the
sealing elements 4, 6 are located between the attachment members 2, 3 and
connectors 11,
12. In this manner, the transition between attachment members 2, 3 and the
first and second
connectors 11, 12 comprises a liquid-tight seal.
[0054] Each attachment member 2,3 has a respective detachable part 20, 30 that
can be
broken off from the rest of the attachment member 2, 3 to allow access to the
container 1. The
detachable part 20 can be broken off from the attachment member 2 in order to
allow the
attachment of a delivery device 5 to the attachment member 2 to provide liquid
to the container
1. In one embodiment, the delivery device 5 can take the form of a syringe (as
shown in FIG.
12A), though other delivery devices are contemplated. Likewise, the detachable
part 30 can be
broken off from attachment member 3 in order, for example, to insert a portion
of a delivery
device through the sealing element 6 and remove the liquid from the container
1 through the
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sealing element 6 in order to supply the liquid to a patient. In one
embodiment, this delivery
device is an infusion set comprising a spike, though other delivery devices
are contemplated.
[0055] Each of the attachment members 2, 3 also has a respective connection
section
21, 31. The connection section 21 can be brought into engagement with the
connector 11 so
as to create a positive lock connection between the attachment member 2 and
the connector
11. Likewise, the connection section 31 can be brought into engagement with
the connector
12 so as to create a positive lock connection between the attachment member 3
and the
connector 12. The connection defined between the first connector 11 and the
attachment
member 2 attached thereto will be explained below.
[0056] FIGS. 3 to 11 show an exemplary embodiment of a connection formed by
the
connector 11 and attachment member 2. The connector 11 is, as previously
described, bonded
to sheets comprising the container 1 and is thus incorporated in an integral
manner between
the sheets. The attachment member 2 can be attached to connector 11 so that,
in its attached
position, attachment member 2 is held in a positive-lock manner on connector
11. The
attachment member 2 has a first section comprising a connection section 21 and
a threaded
portion 22, which connects to it, as well as the detachable part 20. The
attachment member 2
is formed in one piece as a plastic molded part and, in its initial state,
comprises each of the
detachable part 20, the connection section 21, and the threaded portion 22
integrally
connected.
[0057] The connector 11 has a flow opening 111, which is closed to the outside
by the
attachment member 2 when the attachment member 2 is attached to the connector
11. As a result
of this attachment, the attachment member 2 prevents liquid from leaving or
entering the
container 1. As is visible from the sectional view according to HG. 5, when
the attachment
member 2 is attached to the connector 11, ahead 110 of the connector 11 is
disposed through an
opening 210 of the connection section 21 of the attachment member 2. To
axially secure the
connector 11 to the attachment member 2, the connector 11 can include a
circumferential
positive-lock element in the form of annular projection 115. Further, the
connector 11 can also
include positive-lock elements 116, 117 that define axially extending webs and
grooves that
cause the connector 11 to be attached in a rotationally stable manner to
attachment member 2.
Within the opening 210 of the connection section 21 of the attachment member
2, the attachment
member 2 can include complementary positive-lock elements (not shown) in the
form of, for
example, annular recesses that are configured to engage with annular
projection 115. The
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attachment member 2 can also include axially extending webs and/or grooves
defined within the
opening 210 that are configured to engage positive-lock elements 116, 117.
[0058] When the attachment member 2 is attached to the connector 11, the
sealing
element 4 is disposed between attachment member 2 and connector 11. In
particular, the
sealing element 4 can be held in a clamping manner between the attachment
member 2 and the
connector 11. Prior to attachment of the attachment member 2 to the connector
11, the sealing
element 4 can be inserted in an insertion direction E (shown in FIG. 6) into
the opening 210 of
the attachment member 2. The sealing element 4, as shown in FIG. 7, can be
formed as a
rotationally symmetrical body. The sealing element 4 can have a sealing head
40, which is
configured to be received by an engagement opening 221 defined by the threaded
portion 22 of
the attachment member 2. The sealing element 4 can further include a convexly
curved or flat
side 400 that extends out past threaded portion 22 towards the detachable part
20 when the
sealing element 4 is received within the engagement opening 221.
Alternatively, the side 400
can be flush with the upper side of the threaded portion 22.
[0059] The sealing element 4 can also include a cylindrical section 41 that
extends
from the sealing head 40 to a circumferentially-extending shoulder 410. The
shoulder 410
can be configured to extend circumferentially around a substantial entirety of
the sealing
element 4 and rest on a circumferential conical support surface 212 defined
within the
opening 210 of the attachment member 2 at the transition between the
connection section 21
and the threaded portion 22. The cylindrical section 41 of the sealing element
4 can have a
larger diameter than the sealing head 40. However, the shoulder 410 can
project radially
outward past cylindrical section 41. The sealing element 4 can also include a
cylindrical
body 42 that extends downwards from the shoulder 410 and is configured to be
inserted into
the opening 210 of the connection section 21. When the cylindrical body 42 is
positioned
within the opening 210, a clearance can be defmed between the cylindrical body
42 and the
connection section 21. In the depicted embodiment, the cylindrical body 42 has
a smaller
diameter than the shoulder 410. Since the cylindrical body 42 is inserted into
the opening 210
with a clearance defined between the cylindrical body 42 and the
circumferential wall of
connection section 21, the sealing element 4 can be deformed in an
advantageous manner by
the attachment of delivery device 5 to create a flow of liquid through the
sealing element 4
between the delivery device 5 and the container 1.
[0060] The cylindrical body 42 carries a circumferential flange 420 on an end
facing
away from the sealing head 40. The flange 420 can define a lower side 422 that
is configured to
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rest on a support surface 114 of the connector 11. The flange 420 can also
define an upper side
421 opposite the lower side that can be completely exposed and not engage any
surface of the
connector 11. Alternatively, the upper side 421 of the flange 420 can be only
partially exposed.
In this embodiment, when the sealing element 4 is disposed between the
attachment member 2
and the connector 11, the flange 420 can be positioned between an annular
projection 211
defined by the connection section 21 and the support surface 114 on the head
110 of the
connector 11. As such, the flange 420 can be partially held in a clamping
manner between
annular projection 211 and the support surface 114 when the attachment member
2 is attached
to the connector it. In this embodiment, a radially outer section of the
flange 420 is held by the
attachment member 2 in a clamping manner.
100611 Above the flange 420 or on a transition between the cylindrical body 42
and
the flange 420, the cylindrical body 42 can define a recess 423 extending
radially into the
sealing element 4. The recess 423 can be configured to support the deformation
of the sealing
element 4 when the delivery device 5 is attached to the sealing element 4. The
recess 423 can
be formed by a step on the outer side of the cylindrical body 41 In cross
section, the recess
423 can have an essentially flat bottom. For example, the recess 423 can have
a box-like
cross section. In this embodiment, the base and the radial opening of the
recess 423 can have
essentially the same dimensions (as viewed in insertion direction E). However,
other
configurations for the recess 423 are contemplated. The sealing element 4 can
fluffier
comprise a foot section 43 that extends downwardly from the flange 420, which
is configured to
engage the recess 113 on the head 110 of the connector 11.
100621 When attached to the connector 11, the connection section 21 of the
attachment
member 2 rests on the outer flange 112 of the connector 11. Since the sealing
element 4 is
supported on an upper side by an engagement between the shoulder 410 and the
attachment
member 2 and on a lower side by an engagement between the flange 420 and the
support
surface 114 of the connector 11, a defined, secured placement of the sealing
element 4 within
the opening 210 of the attachment member 2 can be guaranteed. The sealing
element 4 can
also define a cylindrical inner opening 44 that extends from the foot section
43, through the
cylindrical body 42 and the cylindrical section 41, and to the sealing head
40. The
cylindrical inner opening 44 can be open to the flow opening 118 of the
connector 11, which
allows a higher volume of flow between the delivery device 5 and the container
1 to be
achieved when the delivery device 5 is attached to the attachment member 2.
The cylindrical
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inner opening 44 can have a diameter in a range of from 1 mm to 5 mm, though
other
diameters are contemplated.
100631 In an initial state, as represented in FIG. 5, the attachment member 2
is
attached with the sealing element 4 to the connector 11, such that the
interior of the connector
11 is fluidly closed off from the outside. In this initial state, the sealing
element 4 is not
accessible from the outside because the upper side 400 of the sealing head 40
is disposed
within the engagement opening 221 of the threaded portion 22 of the attachment
member 2,
and is thus covered from the outside by the detachable part 20.
100641 The detachable part 20 of the attachment member 2 is connected to the
threaded portion 22 via a predetermined breaking point 200. In one embodiment,
the
breaking point 200 take the form of a notch-like circumferential recess,
though the present
disclosure is not intended to be limited to such. In order to attach the
delivery device 5 to the
sealing element 4, and in this rammer create an access to container 1 for
filling it with a
liquid, a user can break the detachable part 20 off of threaded portion 22 by
gripping the
handle element 201 of the detachable part 20 and applying a sufficient force
to release the
detachable part 20 from the threaded portion 22, as shown in FIG. 9. When the
detachable
part 20 is removed from the threaded portion 22, a portion of the attachment
member 2
remains attached to the connector 11 without the detachable part 20, as is
depicted in FIG.
10.
100651 After breaking off the detachable part 20 from the threaded portion 22,
the
sealing element 4 can have its outward-facing side 400 on the sealing head 40
exposed. As a
result, the outward-facing side 400 can be accessed from the outside. In one
embodiment in
which the side 400 is formed convexly and projects over the upper side 222 of
the threaded
portion 22 in a curved manner, the side 400 of the sealing element 4 can be
wiped or dabbed
off in an efficient manner in order to clean and disinfect the sealing element
4 in accordance
with any legal requirements that may be present. Likewise, in another
embodiment in which
the side 400 is substantially flat, the side 400 can also be appropriately
wiped or dabbed off
in an efficient manner in order to clean and disinfect the sealing element 4.
100661 After the side 400 has been cleaned, the delivery device 5 can, as
shown in FIGS.
12A and 12B, be attached to threaded portion 22 by bringing the connection
element 50 of the
delivery device 5, which can comprise a nut or union nut, into contact with
threads 220 of the
threaded portion 22. In particular, threads 500 of the delivery device 5 can
engage the threads
220 of the threaded portion 22 in a screw-like manner. The connecting piece 51
of the delivery
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device 5 can be inserted through the engagement opening 221 defined by the
threaded portion 22
such that the connecting piece 51 presses on sealing head 40 of sealing
element 4. First, the
connecting piece 51 presses downward on the sealing head 40. Then, the
connecting piece 51
opens the sealing head 40 at the slot opening 45 (see FIG. 11). As a result,
the connecting piece
51 penetrates the sealing head 40 at the slot opening 45 and enters into
liquid communication
with the cylindrical inner opening 44 of the sealing element 4, which provides
a flow path
between the delivery device 5 and the flow opening 111 of the connector 11.
The slot opening
45 can define a cross-shaped or straight slot design. However, other
embodiments of the slot
opening 45 are contemplated.
100671 With the pressing of the connecting piece 51 into the engagement
opening 221,
the sealing head 40 is also pressed into the attachment member 2_ The
cylindrical section 41 and
the cylindrical body 42 are forced aside into the available space radially
between the cylindrical
body 42 and the connection section 21 of the attachment member 2. When the
connecting piece
51 is fidly inserted through the sealing head 40, the connecting piece 51
creates a positive lock
connection with the engagement opening 221 and extends through sealing head
40, which
creates an efficient flow connection between connecting piece 51 and the flow
opening 118 on
the head 110 of the connector 11. The flow opening 118 is not affected, or is
only marginally
affected, by the sealing element 4. The delivery device 5 can extend to the
greatest extent
through the sealing element 4 when the delivery device 5 is in a fully
attached state. The fully
attached state can occur when the delivery device 5 is fully tightened in
relation to the
attachment member 2 with its connecting piece 51 through the slot opening 45
of the sealing
element 4, such that a flow between the delivery device 5 and the container 1
can occur
unhindered, or essentially unhindered, through the sealing element 4. The
whole cross section of
the opening in the delivery device 5, through which the liquid transport takes
place, can be
entirely exposed, as shown in FIG. 12B. In one embodiment, the delivery device
5 can have a
syringe body 52 and a plunger 53, where the plunger 53 can be pushed into
syringe body 52
in order to urge a liquid from the syringe body 52 into the container 1.
100681 Because a slot opening 45 is provided in the sealing head 40 of the
sealing
element 4, a needle-free access into the container 1 is created. This needle-
flee access can thus
be accessed via the delivery device 5, and without the use of an injection
needle. When the
delivery device 5 is attached to the attachment member 2, the connecting piece
51 achieves
engagement with the slot opening 45, and in this manner opens the sealing
element to create a
flow between the delivery device 5 and the container 1. After removing the
delivery device 5
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from the attachment member 2, the sealing element 4 again closes automatically
and seals
itself, so that no liquid can escape from the container 1.
100691 FIGS. 13 and 14 show a further exemplary embodiment in which a
connection
assembly comprises the connector 11, the attachment member 2 ranged thereon,
and the
sealing element 4. In this embodiment, the connection assembly is a component
of a
connector 7, where the connector 7 takes the form of a y-connector. The
connector 7 has two
line connections 70, 71, each of which can be connected to a medical line that
comprises an
infusion tube or similar device. Line connections 70, 71 are in fluid
connection with the
connector 11 at a connection point 72, so that a liquid can be provided from a
line system that
is connected to the line connections 70, 71 or can be delivered to the line
system via the
connector 11.
100701 The attachment member 2 is also arranged on the connector 11 in this
exemplary embodiment, and the sealing element 4 is clamped between the
attachment
member 2 and the connector 11. As in the exemplary embodiments according to
FIGS. 1 to
12, the threaded portion 22 of the attachment member 2 is connected to the
detachable part
20, which can be broken off to connect a delivery device 5 (as shown in FIG.
12) to the
threaded portion 22 and to further connect the delivery device 5 to the
connector 11. In an
embodiment in which the sealing element 4 includes a convex side 400, the
sealing element 4
can protrude over the upper side 222 of the threaded portion 22 and thus be
easily accessible.
This allows the side 400 of the sealing element 4 to be easily be wiped off in
order to
disinfect the outward-facing side 400 of the sealing element 4 before
attaching the delivery
device 5. In an embodiment in which the sealing element 4 includes a flat side
400, the side
400 can also be appropriately wiped or dabbed off. In the embodiment shown in
FIGS. 13
and 14, the connector 11 and the attachment member 2 are identical in form and
function to
those previously described for the exemplary embodiment according to FIGS. 1
to 12B.
100711 Continuing with Figures 15-17, another embodiment of a sealing element
604
is depicted. The sealing element 604 can be configured to be disposed between
and attached
to the first connector 11 and the attachment member 2 in substantially the
same way as the
connector 4 as described above. As such, parts of the disclosure related to
the engagement
between the sealing element 604, the first connector 11, and the attachment
member 2 will
not be duplicated here.
100721 The sealing element 604 can be formed having rotationally symmetrical
body.
The sealing element 604 can have a sealing head 640, which is configured to be
received by
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the engagement opening 221 defined by the threaded portion 22 of the
attachment member 2.
The sealing element 604 can include a side 605 that extends out past the
threaded portion 22
of the attachment member 2 when the sealing element 4 is received within the
engagement
opening 221. In one embodiment, the side 605 is convexly curved and extends
out past the
threaded portion 22 towards the detachable part 20 when the sealing element 4
is received
within the engagement opening 221. In another embodiment, the side 605 can be
flush with
the upper side of the threaded portion 22. When the side 605 is exposed after
the detachable
part 20 of the attachment member 2 is broken from the threaded portion 22, the
side 605 can
be wiped or dabbed off in an efficient manner in order to clean and disinfect
the sealing
element 4 in accordance with any legal requirements that may be present.
100731 The sealing element 604 can include a cylindrical section 641 that
extends
from the sealing head 640 to a circumferentially-extending shoulder 610. The
shoulder 610
can be configured to extend circumferentially around a substantial entirety of
the sealing
element 604 and rest on the circumferential conical support surface 212 of the
attachment
member 2. The cylindrical section 641 of the sealing element 604 can have a
larger outer
diameter than the outer diameter of the sealing head MO. However, the shoulder
610 can
define a larger outer diameter than the outer diameter of the cylindrical
section 641. The
sealing element 604 can also include a cylindrical body 642 that extends
downwards from the
shoulder 610 to a flange 620, which will be described below, along the
insertion direction E.
As depicted, the cylindrical body 642 defines a substantially constant
diameter measured
perpendicular to the insertion direction E from the flange 620 to the shoulder
610. The
cylindrical body 642 can be configured to be inserted into the opening 210 of
the connection
section 21 of the attachment member 2. When the cylindrical body 642 is
positioned within
the opening 210, a clearance can be defined between the cylindrical body 642
and the
connection section 21, which allows the cylindrical body 642 to deform to
create a flow path
through the sealing element 604. The outer diameter of the shoulder 610 can be
greater than
the outer diameter of the cylindrical body 642.
100741 Continuing with Figures 15-17, the flange 620 of the sealing element
604 can
extend radially from the sealing element 604. The flange 620 can define a
lower surface 622
configured to engage a support surface 114 of the connector 11. The flange 620
can also
define an upper surface 621 opposite the lower surface that is completely
exposed, such that
the upper surface 621 does not engage any portion of the connector 11.
Alternatively, the
upper surface 621 can be only partially exposed. In this embodiment, when the
sealing
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element 604 is disposed between the attachment member 2 and the connector 11,
the flange 620
can be positioned between the aimular projection 211 and the support surface
114. As such, the
flange 620 can be partially held in a damping manner between annular
projection 211 and the
support surface 114 when the attachment member 2 is attached to the connector
11. In this
embodiment, a radially outer section of the flange 620 is held by the
attachment member 2 in a
clamping manner. The flange 620 can have an outer diameter that is greater
than the outer
diameter of the shoulder 610 and the cylindrical body 642.
100751 Additionally, the sealing element 604 can further comprise a foot
section 643
that extends downwardly from the flange 620, where the foot section 643 is
configured to be
received by the recess 113 of the connector 11. The sealing element 604 can
further include an
inner opening 644 that extends through the foot section 643, through the
cylindrical body 642,
and through the cylindrical section 641 to the sealing head MO. The inner
opening 644 can be
open to the flow opening 118 of the connector 11, which allows a higher volume
of flow
between the delivery device 5 and the container 1 to be achieved when the
delivery device 5
is attached to the attachment member 2. The inner opening 644 can have a
diameter in a
range of from 1 mm to 5 mm, though other diameters are contemplated. The inner
opening
644 can slightly expand as it extends downward along the insertion direction
E. As depicted,
the inner surface 651 of the sealing element 604 that defines the inner
opening 644 can be
slightly conical. In some embodiments, the inner surface 651 of the sealing
element 604 that
defines the inner opening 644 can define an angle 0 relative to the insertion
direction E. The
angle 0 can be about 0.5 degrees or more, 0.8 degrees or more, 1.0 degree or
more, 1.5
degrees or more, 2.0 degrees or more, 5.0 degrees or more, 8.0 degrees or
more, 10 degrees
or more, or 15 degrees or more. In other embodiments, the angle 0 can be about
20 degrees
or less, e.g., 15 degrees or less, 12 degrees or less, 8.0 degrees or less,
6.0 degrees or less, or
3.0 degrees or less. In yet other embodiments, the angle 0 can be in the range
of 0.5-15
degrees, 0.5-8.0 degrees, 0.8-5.0 degrees, 0.8-3.0 degrees, or 1.0-2.0
degrees. However,
other angles, and thus other degrees of widening of the inner opening 644, are
contemplated.
Alternatively, the inner opening 644 may define a substantially constant
diameter along its
length.
100761 After the side 605 has been cleaned, the connecting piece 51 of the
delivery
device 5 is inserted through the engagement opening 221 defined by the
threaded portion 22
such that the connecting piece 51 presses on the sealing head 640. With the
pressing of the
connecting piece 51 into the engagement opening 221, the sealing head MO is
also pressed into
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the attachment member 2. The cylindrical section 641 and the cylindrical body
642 are forced
aside into the available space radially between the cylindrical body 642 and
the connection
section 21 of the attachment member 2. As a result, the opening 645 is
configured to transition
from a closed state to an open state when the cylindrical body 642 deforms.
When the opening
645 is in an open state, the opening 645 and the inner opening 644 of the
sealing element 604
define a flow path through the sealing element 604 that allows fluid
communication between the
delivery device 5 and the container 1. The opening 645 can define a cross-
shaped design, a
straight slot design, or any other design as desired. When the connecting
piece 51 is fully inserted
through the sealing head 640, the connecting piece 51 creates a positive lock
connection with the
engagement opening 221 and extends through sealing head 640, which creates an
efficient flow
connection between connecting piece 51 and the flow opening 118 on the head
110 of the
connector 11. The flow opening 118 is not affected, or is only marginally
affected, by the sealing
element 604. The delivery device 5 can extend to the greatest extent through
the sealing element
604 when the delivery device 5 is in a fully attached state. The fully
attached state can occur
when the delivery device 5 is fully tightened in relation to the attachment
member 2 with its
connecting piece 51 through the slot opening 645 of the sealing element 604,
such that a flow
between the delivery device 5 and the container 1 can occur unhindered, or
essentially
unhindered, through the sealing element 604.
100771 Because an opening 645 is provided in the sealing head 640 of the
sealing
element 604, a needle-free access into the container 1 is created. This needle-
free access can
thus be accessed via the delivery device 5, and without the use of an
injection needle. When the
delivery device 5 is attached to the attachment member 2, the connecting piece
51 achieves
engagement with the slot opening 645, and in this manner opens the sealing
element to create a
flow between the delivery device 5 and the container 1. After removing the
delivery device 5
from the attachment member 2, the sealing element 604 again closes
automatically and seals
itself, so that no liquid can escape from the container 1.
[0078] While various inventive aspects, concepts and features of the
inventions may
be described and illustrated herein as embodied in combination in the
exemplary
embodiments, these various aspects, concepts and features may be used in many
alternative
embodiments, either individually or in various combinations and sub-
combinations thereof.
Unless expressly excluded herein all such combinations and sub-combinations
are intended
to be within the scope of the present inventions. Still further, while various
alternative
embodiments as to the various aspects, concepts, and features of the
inventions¨such as
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alternative materials, structures, configurations, methods, devices and
components,
alternatives as to form, fit and function, and so on¨may be described herein,
such
descriptions are not intended to be a complete or exhaustive list of available
alternative
embodiments, whether presently known or later developed. Those skilled in the
art may
readily adopt one or more of the inventive aspects, concepts or features into
additional
embodiments and uses within the scope of the present inventions even if such
embodiments
are not expressly disclosed herein. Additionally, even though some features,
concepts or
aspects of the inventions may be described herein as being a preferred
arrangement or
method, such description is not intended to suggest that such feature is
required or necessary
unless expressly so stated. Still further, exemplary or representative values
and ranges may
be included to assist in understanding the present disclosure; however, such
values and
ranges are not to be construed in a limiting sense and are intended to be
critical values or
ranges only if so expressly stated. Moreover, while various aspects, features,
and concepts
may be expressly identified herein as being inventive or forming part of an
invention, such
identification is not intended to be exclusive, but rather there may be
inventive aspects,
concepts, and features that are fully described herein without being expressly
identified as
such or as part of a specific invention, the scope of the inventions instead
being set forth in
the appended claims or the claims of related or continuing applications.
Descriptions of
exemplary methods or processes are not limited to inclusion of all steps as
being required in
all cases, nor is the order that the steps are presented to be construed as
required or necessary
unless expressly so stated.
100791 While the invention is described herein using a limited number of
embodiments, these specific embodiments are not intended to limit the scope of
the invention
as otherwise described and claimed herein. The precise arrangement of various
elements and
order of the steps of articles and methods described herein are not to be
considered limiting.
For instance, although the steps of the methods are described with reference
to sequential
series of reference signs and progression of the blocks in the figures, the
method can be
implemented in a particular order as desired.
22
