U.S. patent application number 13/577016 was filed with the patent office on 2013-02-14 for closure cap for a receptacle for receiving medical liquids, and receptacle.
This patent application is currently assigned to Fresenius Kabi Deutschland GmbH. The applicant listed for this patent is Torsten Brandenburger, Ismael Rahimy. Invention is credited to Torsten Brandenburger, Ismael Rahimy.
Application Number | 20130037509 13/577016 |
Document ID | / |
Family ID | 42314778 |
Filed Date | 2013-02-14 |
United States Patent
Application |
20130037509 |
Kind Code |
A1 |
Rahimy; Ismael ; et
al. |
February 14, 2013 |
CLOSURE CAP FOR A RECEPTACLE FOR RECEIVING MEDICAL LIQUIDS, AND
RECEPTACLE
Abstract
The invention relates to a closure cap for a receptacle for
receiving medical liquids and to a receptacle for medical liquids
which has such a closure cap. The closure cap (1) according to the
invention comprises a first connector (2) for the needle-free
injection of a medical liquid and a second connector (3) for the
needle-free withdrawal of a medical liquid, wherein the first
connector (2) has an outwardly directed first connector part (4)
with a conical recess (8) for sealingly receiving a cone stem (26)
of a first device (28, 29) to be connected, and the second
connector (3) has an outwardly directed second connector part (5)
with a conical recess (9) for sealingly receiving a cone stem of a
second device to be connected.
Inventors: |
Rahimy; Ismael; (Friedberg,
DE) ; Brandenburger; Torsten; (Reichelsheim,
DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Rahimy; Ismael
Brandenburger; Torsten |
Friedberg
Reichelsheim |
|
DE
DE |
|
|
Assignee: |
Fresenius Kabi Deutschland
GmbH
Bad Homburg
DE
|
Family ID: |
42314778 |
Appl. No.: |
13/577016 |
Filed: |
February 15, 2011 |
PCT Filed: |
February 15, 2011 |
PCT NO: |
PCT/EP11/52190 |
371 Date: |
September 17, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61304831 |
Feb 16, 2010 |
|
|
|
Current U.S.
Class: |
215/247 ;
215/250; 215/316 |
Current CPC
Class: |
A61J 1/2006 20150501;
A61M 2039/267 20130101; A61J 1/1481 20150501; A61J 1/1487 20150501;
A61J 1/18 20130101; A61M 39/26 20130101; B65D 51/002 20130101; A61J
1/1425 20150501; A61J 1/1418 20150501; A61J 1/1406 20130101; A61J
1/1468 20150501; A61J 1/1431 20150501 |
Class at
Publication: |
215/247 ;
215/316; 215/250 |
International
Class: |
B65D 47/36 20060101
B65D047/36; B65D 41/32 20060101 B65D041/32; B65D 47/00 20060101
B65D047/00 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 16, 2010 |
EP |
10153721.5 |
Claims
1-13. (canceled)
14. A closure cap for a receptacle for receiving medical liquids,
comprising a first connector for injecting a medical liquid and a
second connector for withdrawing a medical liquid, wherein the
first connector has an outwardly directed first connector part with
a conical recess for sealingly receiving a cone stem of a first
device to be connected, and the second connector part with a
conical recess for sealingly receiving a cone stem of a second
device to be connected.
15. The closure cap as claimed in claim 14, wherein the first
connector part and/or the second connector part are designed as a
Luer lock female connector.
16. The closure cap as claimed in claim 14, wherein the first
connector has a first membrane ad a first piercing element, wherein
the first membrane is arranged between the conical recess of the
first connector part and the piercing element such that, by
connecting the first device, the first membrane is pressed against
the first piercing element and pierced by the first piercing
element.
17. The closure cap as claimed in claim 14, wherein the second
connector has a second membrane and a second piercing element,
wherein the second membrane is arranged between the conical recess
of the second connector part and the second piercing element such
that, by connecting the second device, the second membrane is
pressed against the second piercing element and pierced by the
second piercing element.
18. The closure cap as claimed in claim 16, wherein the first
piercing element is designed as a hollow body with a tip and/or the
second piercing element is designed as a hollow body with a
tip.
19. The closure cap as claimed in claim 14, wherein the first
membrane and/or the second membrane are slit.
20. The closure cap as claimed in claim 14, wherein the first
connector has a first socket in which the first membrane and the
first piercing element are inserted and/or the second connector has
a second socket in which the second membrane and the second
piercing element are inserted.
21. The closure cap as claimed in claim 20, wherein the first
connector has a first flange by means of which the first membrane
and first piercing element are fastened positively in the first
socket and/or the second connector has a second flange by means of
which the second membrane and second piercing element are fastened
positively in the second socket.
22. The closure cap as claimed in claim 14, additionally comprising
a first break-off part which is connected to the first connector
and closes it off in a liquid-tight manner, and/or a second
break-off part which is connected to the second connector and
closes it off in a liquid-tight manner.
23. The closure cape as claimed in claim 14, additionally
comprising a cover region and an edge region, wherein the first
connector an the second connector are arranged in the cover
region.
24. The closure cap as claimed in claim 14, wherein the first
connector, second connector and, if appropriate, edge region and
cover region and, if appropriate, first break-off part and second
break-off part are designed in one part, preferably integrally.
25. A receptacle for medical liquids comprising a closure cap as
claimed in claim 14.
26. The receptacle as claimed in claim 25, wherein the receptacle
is designed as a bottle, preferably as an SBM
(stretch-blow-molding) bottle.
Description
TECHNICAL FIELD
[0001] The invention relates to a closure cap for a receptacle for
receiving medical liquids, in particular for receiving liquids
which are used in the field of infusion, transfusion, clinical
nutrition or dialysis. Furthermore, the invention relates to a
receptacle for medical liquids which has such a closure cap.
PRIOR ART
[0002] DE 10 2007 005 407 A1 discloses a closure cap for a
receptacle for receiving medical liquids. The closure cap has a
cover part and an edge part and a first connector and second
connector arranged in the cover part. The first connector is
designed as an injection part. It comprises an outwardly directed
connector part with a conical recess for sealingly receiving the
cone stem of a needleless injection syringe and an inwardly
directed closure part which has a self-sealing membrane for closing
the recess of the connector part. The second connector is designed
as a withdrawal part and comprises an outwardly directed connector
part with a cylindrical recess and an inwardly directed closure
part which has a self-sealing membrane for closing the recess of
the connector part. The closure cap makes it possible via the first
connector to inject a liquid without having to use an injection
needle, while the second connector can be used to withdraw liquid
via an infusion spike from the receptacle connected to the closure
cap.
BRIEF DESCRIPTION OF THE INVENTION
[0003] The closure cap according to the invention comprises a first
connector for injecting a medical liquid into a receptacle
connected to the closure cap, in particular into an infusion
receptacle, and a second connector for withdrawing a medical liquid
from a receptacle connected to the closure cap, in particular from
an infusion receptacle, wherein the first connector has an
outwardly directed first connector part with a conical recess for
sealingly receiving a cone stem of a first device to be connected,
and the second connector has an outwardly directed second connector
part with a conical recess for sealingly receiving a cone stem of a
second device to be connected. This makes it possible to form a
closure cap with at least two connectors which can each be
sealingly connected to a needleless or infusion spike-less device.
Since devices without a needle or infusion spike can be connected
to both connectors, there is a considerable reduction in the risk
of injury of the user or of damage to the receptacle which is
connected to the closure cap. Moreover, the tightness of such a
connection is ensured. If the first and/or second connector part is
designed with a lock, which is preferred according to the
invention, it is furthermore possible to prevent a situation in
which, for example, jerky movements of the patient or tensile
loading cause the connection to be inadvertently released, with the
result that the patient and/or the care personnel could be
contaminated with highly toxic medicaments, and expensive
medicaments such as antibiotics or cytostatics would possibly have
to be discarded.
[0004] In principle, the closure cap can be used for any desired
receptacles. The closure cap is preferably a closure cap for a
receptacle for receiving medical liquids which are used in
infusion, transfusion, clinical nutrition or dialysis. The
receptacle is preferably designed as a bottle, in particular as a
plastic bottle. The plastic bottle is preferably designed as an SBM
(stretch-blow--molding) receptacle.
[0005] In an advantageous development, the first and/or the second
connector part is designed as a Luer connector. Lower connectors
are component parts of standardized cone connections which are used
in particular in medical technology and which have a cone stem and
a cone sleeve which are used for the connection of medical devices.
The first and/or the second connector part can be designed both as
a non-lockable Luer connector or as a lockable Luer connector (also
referred to as a "Luer lock connector"). Owing to the
standardization, the design of the first and/or second connector
part as a Luer connector ensures a defined connection mechanism.
Moreover, universality of the connectors is provided, the situation
does not arise of having available different variants of connectors
for different countries, and the risk of misuse as a result of a
connection of unsuitable devices is reduced. The first and/or the
second connector part is preferably designed as a Luer lock
connector, thereby allowing a defined locking of the connection
with a device to be connected and thus contributing to the safety
of the connection, in particular against unintended release of the
connection.
[0006] According to a further advantageous development, the first
connector comprises a first membrane and a first piercing element,
wherein the first membrane is arranged between the conical recess
of the first connector part and the piercing element such that, by
connecting the first device, the first membrane is pressed against
the first piercing element and pierced. The membrane makes it
possible, in its closed state, to prevent transport of liquid
through the connector and to allow liquid transport only on
opening. The piercing element allows easy and defined piercing of
the membrane and ensures that the membrane is actually opened. The
membrane is preferably designed in such a way and arranged in such
a way that a device to be connected to the connector opens the
membrane during the connection. For example, the device may
comprise a Luer male connector with an inner cone which pierces the
membrane during connection and opens it in this way. The first
connector part is correspondingly designed as a Luer female
connector or Luer lock female connector, which is preferred
according to the invention. Furthermore, the membrane is preferably
designed as an elastic body such that, when releasing the device,
the membrane returns to its starting position in which the
connector is closed off in a liquid-tight manner by the
membrane.
[0007] The piercing element is preferably designed as a hollow body
with a tip. The membrane can be pierced by the tip. Since the
piercing element is designed as a hollow body, liquid transport can
take place through the piercing element. The tip can be suitably
sharpened to facilitate piercing of the membrane.
[0008] In a further advantageous configuration, the second
connector comprises a membrane and a piercing element in a
corresponding manner to the first connector. The second connector
part is preferably designed as a Luer female connector or Luer lock
female connector. It is possible in particular for the same
membrane and/or the same piercing element to be used for the first
connector and the second connector, with the result that the number
of different parts is reduced and thus production costs can be
lowered. Furthermore, the first connector and second connector can
be designed to be identical. This has the advantage that in
time-critical situations as may occur, for example, in the rescue
service or in the operating room, the error rate can be
substantially minimized since it is no longer necessary to pay
attention to which connector is intended for withdrawal and to
which connector is intended for injection.
[0009] The receptacle according to the invention for medical
liquids comprises a closure cap according to the invention. The
receptacle is preferably designed as a bottle.
[0010] The dependent claims describe further advantageous
developments of the invention.
[0011] The invention will be explained in more detail below with
reference to exemplary embodiments which are illustrated by means
of multiple figures.
BRIEF DESCRIPTION OF THE FIGURES IN THE DRAWING
[0012] In the drawing:
[0013] FIG. 1 shows a perspective view of an embodiment of a
closure cap according to the invention,
[0014] FIG. 2 shows a bottom view of the closure cap shown in FIG.
1,
[0015] FIG. 3 shows a side view of the closure cap shown in FIG.
1,
[0016] FIG. 4 shows a plan view of the closure cap shown in FIG.
1,
[0017] FIG. 5 shows a cross section through the closure cap shown,
along the section line A-A indicated in FIG. 4,
[0018] FIG. 6 shows a perspective view of the closure cap shown in
FIG. 1, with a syringe connected to the first connector,
[0019] FIG. 7 shows a cross section through the closure cap shown
in FIG. 6, with a connected syringe, along a section line
corresponding to the section line A-A indicated in FIG. 4,
[0020] FIG. 8 shows a perspective view of the closure cap shown in
FIG. 1, with a tube connected to the first connector,
[0021] FIG. 9 shows a cross section through the closure cap shown
in FIG. 6, with a connected transfer tube, along a section line
corresponding to the section line A-A indicated in FIG. 4.
DESCRIPTION OF THE TYPES OF EMBODIMENT
[0022] FIGS. 1 to 8 show an embodiment of a closure cap 1 according
to the invention in various views and having various connected
devices.
[0023] The closure cap 1 is designed as a closure cap for a
receptacle of medical liquids and comprises a first connector 2 for
injecting a medical liquid and a second connector 3 for withdrawing
a medical liquid. The first connector 2 and the second connector 3
are arranged in a cover region 19 of the closure cap 1.
Furthermore, the closure cap 1 comprises an edge region 20 which
surrounds the cover region 19 and which is designed to place the
closure cap 1 on a receptacle. In this exemplary embodiment, the
edge region 20 is designed in such a way that it allows the closure
cap 1 to be placed on an SBM plastic bottle, which is not
represented in more detail, and to be connected therewith in a
liquid-tight and germ-tight/bacteria-tight manner. For this
purpose, the edge region comprises a peripheral groove 21, see FIG.
5, with which a corresponding web or edge of a connector of the
bottle can be engaged. The liquid-tight and germ-tight connection
between the receptacle and the closure cap 1 can be produced in
various ways, for example by welding, plugging, snap-fastening,
screwing, overmolding and/or adhesive bonding.
[0024] The first connector 2 comprises, see FIG. 5 and FIG. 7, a
first outwardly directed (i.e. directed away from the receptacle to
be connected) connector part 4 with a conical recess 8 for
sealingly receiving a cone stem of a first device to be connected
and a second outwardly directed connector part 5 with a conical
recess 9 for sealingly receiving a cone stem of a second device to
be connected. In this exemplary embodiment, both the first
connector part 4 and the second connector part 5 are designed as a
Luer connector, here as a Luer lock female connector according to
ISO standard 594-2:1998 or EN1707:1996.
[0025] Furthermore, the first connector 2 comprises a first closure
part 22 with a first socket 13 which adjoins flush with the first
connector part 4 and is directed inwardly, i.e. faces the
receptacle to be connected, and the second connector 3 comprises a
second closure part 23 with a second socket 14 which likewise
adjoins flush with the first connector part 4 and is directed
inwardly. In this exemplary embodiment, the first socket 13 and the
second socket 14 are designed to be substantially cylindrical. The
first closure part 22 and the second closure part 23 are situated
on the side of the cover region 19 facing the receptacle to be
connected, and the first connector part 4 and the second connector
part 5 are situated on the side of the cover region 19 facing away
from the receptacle to be connected.
[0026] A first membrane 6 and a first piercing element 7 are
arranged in the first socket 13, and a second membrane 10 and a
second piercing element 11 are arranged in the second socket 14; in
this respect see FIG. 7 or FIG. 9 (in FIG. 5 the membranes 6, 10
and the piercing elements 7, 11 have been omitted for the sake of
clarity). The first membrane 6 is arranged between the conical
recess 8 of the first connector part 4 and the first piercing
element 7, and the second membrane is arranged between the conical
recess 9 of the second connector part 5 and the second piercing
element 11. In the closed state, the membranes 6, 7 prevent liquid
transport through the two connectors 2, 3 and in the opened state
of the membranes 6, 10 liquid transport through the connectors 2, 3
is enabled. The membranes 6, 7 are made of an elastic material such
that the membranes pass automatically from an opened position into
the closed position and can thus close off the connectors in a
liquid-tight and germ-tight manner. FIGS. 7 and 9 show the first
membrane 6 in a closed state, that is to say in a state in which
liquid transport through the first connector 2 is prevented, and
the second membrane 10 in an opened state in which liquid transport
through the second connector 3 is ensured.
[0027] The first piercing element 7 and the second piercing element
11 are each designed as rigid, disk-shaped bodies with a hollow tip
12 arranged in the centre. The hollow tip ensures transport of a
liquid through the piercing element 7, 11. The tips 12 are arranged
below the assigned membranes 6, 10 and oriented with respect to the
respective membrane 6 or 10 such that, with a pressure on the
connector side, the respective membrane 6 or 10 is pressed against
the piercing element 7, 11 and is opened in this manner. To
facilitate opening, the tips 12 of the piercing elements 7, 11 are
sharpened. As a further measure to facilitate opening, the first
membrane 6 and the second membrane 11 are slit in the centre.
[0028] In the region of the first closure part 22, the first
connector has an inwardly directed peripheral flange 15 behind
which the first piercing element 7 positively engages and is
pressed against the first membrane 6, with the result that the
first membrane 6 is positively clamped in between the first
piercing element 7 and a step 24 formed by the first closure part
22. Here, the membrane 6, supported by the pressing force exerted
by the first piercing element 7, seals against the inner wall of
the closure part 22, with the result that no liquid or germs can
pass unwantedly through the first connector 2 between the membrane
6 and inner wall of the closure part 22. It is thus ensured that
liquid transport occurs only when the membrane 6 is opened.
Correspondingly, in the region of the second closure part 23, the
second connector has an inwardly directed peripheral flange 16
behind which the second piercing element 11 positively engages and
is pressed against the second membrane 10, with the result that the
second membrane 10 is clamped in positively between the second
piercing element 11 and a step 25 formed by the second closure part
23. The second membrane 10, supported by the pressing force exerted
by the second piercing element 11, seals against the inner wall of
the second closure part 23, with the result that no liquid can pass
unwantedly through the second connector 3 between the membrane 10
and inner wall of the closure part 23.
[0029] FIG. 5 shows the closure cap 1 without the flanges 15, 16.
Connectors 2, 3, cover region 19 and edge region 20 do not have any
undercuts, allowing a simple and cost-effective production of the
closure cap 1, since complicated mechanisms for demolding are
dispensed with. The edges of the closure parts 22, 23 are flanged
after inserting the membranes 6, 10 and the piercing elements 7,
11, resulting in the closure cap 1 shown in FIGS. 7, 9.
[0030] The first connector 2 and the second connector 3 are
designed in such a way that, by connecting a device having a Luer
lock male connector, the hollow inner core of the Luer lock male
connector presses the respective membrane 6, 10 of the connector 2,
3 against the piercing element 7, 11 in the course of locking the
device with the respective connector 2, 3, with the result that the
membrane 6, 10 is opened. The force to be applied for piercing the
piercing point is very low by comparison with a conventional
connection using an infusion spike. Consequently, this connection
is user friendly, safe, reliable and protected from contact.
[0031] The outer diameter of the hollow tip 12 is tailored to the
inner diameter of the inner cone of the Luer lock male connector,
with the result that the inner cone can be pushed over a portion of
the tip 12. This is depicted by way of example in FIGS. 7, 9, where
a needleless syringe 28 and a transfer tube 29 having a Luer lock
male connector 27 which comprises a hollow inner cone 26 are
connected to the second connector 3. After connecting the
respective device 28, 29, liquid transport takes place through the
inner cone 26 and the tip 12 of the piercing element 11. If the
connected device is removed, the membranes 6, 10 move back into
their starting state owing to their elasticity and restoring force
and close the connectors 2, 3 in a liquid-tight manner again.
[0032] Apart from the external thread of the Luer lock, the first
connector 2 and the second connector 3 are designed to be
substantially rotationally symmetrical. Furthermore, in this
exemplary embodiment, the connector 2 and connector 3 including the
membranes 6, 10 and piercing elements 7, 11 are identical.
[0033] The first connector 2 is closed off in a liquid-tight and
bacteria-tight manner with a break-off part 17, and the second
connector 3 is closed off in a liquid-tight and bacteria-tight
manner with a second break-off part 18. The break-off parts 17, 18
prevent any contamination of the connectors 2, 3 prior to their use
and ensure sterility and integrity of the interior. The break-off
parts 17, 18 are connected via a predetermined breaking point 30,
see FIG. 5, to the respective connector 2, 3 and each have a tab
31, 32 via which the break-off parts 17, 18 can be broken off
manually from the respective connector. The break-off parts 17, 18
can be provided with symbols which indicate a liquid transport
direction, for example with arrows in the form of a recess or an
embossing. Irrespective of such symbols, the connectors 2, 3 are
designed for liquid transport in both directions in this exemplary
embodiment.
[0034] The connectors 2, 3, break-off parts 17, 18, cover region 19
and edge region 20 are designed here as a one-part, in particular
integral, injection molding made of a plastic. Connectors 2, 3,
cover region 19, edge region 20 and break-off parts 17, 18 are made
of polypropylene in this case. Alternatively, for example,
polyethylene (PE) or HDPE (high-density PE) would also be suitable.
The respective piercing element 7, 11 is likewise an injection
molding made of plastic, for example of polypropylene (PP) or
polycarbonate (PC) or acrylonitrile-butadiene-styrene (ABS).
Alternatively, the piercing element 7, 11 can also be made of
metal. This is particularly advantageous in the case that there is
to be no slitting of the membranes 6, 10. The respective membrane
6, 10 is a membrane made of an elastic material, for example of a
thermoplastic elastomer (TPE) or of polyisoprenes. Alternatively,
the membrane can also consist of a silicone, chlorobutyl or
bromobutyl.
[0035] A closure cap 1 having two identical connectors 2, 3 has
been described in the exemplary embodiment. Although this is a
preferred embodiment, it is of course possible to design the
connectors 2, 3 to be different from one another. As a further
alternative, one of the connector parts 4, 5 or both connector
parts 4, 5 can be designed as a Luer connector without lock
function, in particular as a Luer female connector. Alternatively,
the first and/or the second connector part 4, 5 can furthermore
also be designed as a Luer-like connector, for example as a
large-bore connector or as a super large-bore connector. A
large-bore connector or super large-bore connector allows a higher
flow rate than a Luer connector, thus being advantageous, for
example, for dialysis or for the transfer of a flushing solution in
urology or arthroscopy.
* * * * *