U.S. patent application number 17/204344 was filed with the patent office on 2021-07-22 for container system and method.
This patent application is currently assigned to Boehringer Ingelheim Vetmedica GmbH. The applicant listed for this patent is Boehringer Ingelheim Vetmedica GmbH. Invention is credited to Cristiano TUNESI.
Application Number | 20210220222 17/204344 |
Document ID | / |
Family ID | 1000005504893 |
Filed Date | 2021-07-22 |
United States Patent
Application |
20210220222 |
Kind Code |
A1 |
TUNESI; Cristiano |
July 22, 2021 |
CONTAINER SYSTEM AND METHOD
Abstract
A container system having at least two containers, wherein the
container system comprises a light member which is configured to
provide information through the emission of emission of
chemiluminescent light, wherein the container system is configured
to provide or trigger the light member to provide the information
through the emission of light when a step related to preparation of
a mixture of the contents of the containers is performed. In
particular, triggering occurs when the containers are separated
from one another and/or when a fluidic connection is created
between the containers.
Inventors: |
TUNESI; Cristiano; (Sant
Cugat del Valles, ES) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Boehringer Ingelheim Vetmedica GmbH |
Ingelheim am Rhein |
|
DE |
|
|
Assignee: |
Boehringer Ingelheim Vetmedica
GmbH
Ingelheim am Rhein
DE
|
Family ID: |
1000005504893 |
Appl. No.: |
17/204344 |
Filed: |
March 17, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15841508 |
Dec 14, 2017 |
10966904 |
|
|
17204344 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61J 1/2027 20150501;
A61J 2205/20 20130101; A61J 1/2051 20150501; A61J 2200/70 20130101;
A61J 1/2089 20130101; A61D 1/025 20130101; A61J 1/18 20130101; A61J
1/1406 20130101; B65D 71/50 20130101; A61J 1/201 20150501; B65D
21/0231 20130101; G08B 5/36 20130101; A61J 1/1412 20130101; B65D
81/3211 20130101 |
International
Class: |
A61J 1/18 20060101
A61J001/18; A61J 1/20 20060101 A61J001/20; B65D 21/02 20060101
B65D021/02; B65D 71/50 20060101 B65D071/50; B65D 81/32 20060101
B65D081/32; A61J 1/14 20060101 A61J001/14; G08B 5/36 20060101
G08B005/36 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 16, 2016 |
EP |
16 020 500.1 |
Claims
1. A container system, comprising: at least two containers, and a
light member which is configured to provide information by the
emission of light by chemiluminescence, wherein the light member is
triggerable to provide the information through the emission of
chemiluminescent light produced in response to the commencement of
actions for preparing a mixture from contents of the
containers.
2. The container system according to claim 1, wherein the
containers each comprise a connecting arrangement, and wherein the
connecting arrangements are configured for enabling said
preparation of a fluidic connection between the containers.
3. The container system according to claim 2, wherein the container
system is configured to activate the light member to emit light or
to change properties of light emitted by the light member when said
actions are commenced by preparation of the fluidic connection
between the containers by the connecting arrangements.
4. The container system according to claim 2, wherein the
connecting arrangements are configured to prepare the fluidic
connection by actions comprising at least one of insertion of one
connecting arrangements into the other or twisting the connecting
arrangements relative to one another, the emission of
chemiluminescent light being initiated by said actions.
5. The container system according to claim 2, wherein at least one
of the connecting arrangements of the containers is closed off by
means of a cap-shaped cover device, and wherein removing of the
cover device initiates the emission of chemiluminescent light.
6. The container system according to claim 2, wherein the
connecting arrangements are arranged at a bottom or opposite of a
withdrawal opening of the respective container of the container
system.
7. The container system according to claim 2, wherein the
containers are bottles with bottle necks, and the connecting
arrangements are arranged on an opposite end of the bottle from the
bottle necks.
8. The container system according to claim 1, wherein the light
member is part of an exterior adornment of at least one of the
containers.
9. The container system according to claim 8, wherein the light
member is a label on the container.
10. The container system according to claim 2, wherein the light
member is configured and attached to at least one of the containers
in a manner such that the light member is automatically pressed by
a user when the connecting arrangements are moved or plugged into
one another for preparing the fluidic connection by the user, the
emission of chemiluminescent light being initiated by said
pressing.
11. The container system according to claim 2, wherein the
container system has at least one trigger element acting on or
deforming the light member when the fluidic connection is prepared,
thus activating the emission of chemiluminescent light.
12. The container system according to claim 11, wherein the trigger
element is a pin or a seal or a tab.
13. The container system according to claim 11, wherein the trigger
element is drivable or activatable by means of or caused by one or
more of a rotational movement of the connecting arrangements
relative to one another, or by deformation of mouth-shaped portions
of the connecting arrangements, or by plugging the connecting
arrangements into one another, or by removing a cap-shaped cover
device closing off at least one of the connecting arrangements.
14. The container system according to claim 1, wherein the light
member is activated by combining of two or more chemicals.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of commonly-owned,
co-pending U.S. patent application Ser. No. 15/841,508 filed Dec.
14, 2017, which claims the benefit of priority to European Patent
Application No. 16 020 500.1 filed Dec. 16, 2016, the contents of
which are incorporated herein by reference in their entirety.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The present invention relates to container systems
comprising at least two containers that are fluidically
connectable.
[0003] In medicine, it is known to transfer substances from one
container into another. For example, mixtures of medicaments or
substances are produced in a mixing bottle, by transferring first
the contents of one container and then of a second container into
the mixing bottle, then sealing the mixing bottle, and producing a
mixture by agitation.
Description of Related Art
[0004] International Patent Application Publication WO 2013/104550
A and corresponding U.S. Pat. No. 9,474,692 relate to a kit for the
production of a combined vaccine, wherein two bottles each have a
septum and the kit comprises a double needle for piercing both
septa and thereby providing a continuous fluidic connection between
the bottles.
[0005] A mixture of substances can have a limited viability, for
example due to physical, chemical or biological processes affecting
active substances within the mixture. Accordingly, there is a
period of time, starting from the point in time where the mixture
is produced and ending where the viability cannot be guaranteed any
more, referred to as viability or viability time span or just
period time. The viability in particular can be based on or
influenced by potential contamination, oxidation, coagulation or
interaction of the substances.
SUMMARY OF THE INVENTION
[0006] A primary object of the present invention is to provide a
container system and a method for improving reliability or
application safety, in particular of mixtures having a limited
viability.
[0007] This object is achieved by a container system and a method
as described herein.
[0008] The present disclosure generally relates to packages
preferably including one or more medicaments therein, such as a
vaccine. In particular, the present disclosure relates to packages,
such as containers like medication bottles, that comprise or
include one or more light members thereon that may be activated at
a desired time to provide an end user of the package with
information about the package or the contents therein. The packages
including the light members thereon may reduce improper use of the
medicament contained therein and improve overall compliance with
instructions for proper use.
[0009] Farm animals receive numerous vaccines and medicaments over
their lifetime to ensure their health and well-being. Some
vaccinations are given once during the life of the animal while
others are given annually. To save on costs, many farmers
administer the vaccinations themselves rather than enlisting the
services of a professional veterinarian. In some countries, health
and safety regulations permit the farmer to administer the
vaccinations to their herd, while in other countries a professional
veterinarian is required.
[0010] For example, bovine viral diarrhea ("BVD") is the number one
economically significant disease in cattle worldwide with
infections occurring in all countries where cattle are raised.
Although it is normally an infection of cattle, it has the ability
to cause infections in other animals such as pigs, sheep, goats,
alpacas, deer, reindeer, and bison. An infection by this virus may
be difficult to recognize and only a small percentage of infected
animals show clinical signs of infection. This virus is well known
for reducing milk production and increasing the risk of death. It
can stress adult cattle and produce abortions and birth defects in
calves that are born to mothers that are infected by the virus. The
economic impact worldwide is substantial.
[0011] In spite of the availability of several commercial vaccines
like that for BVD, infections are still quite common worldwide.
Although conventional parenteral and intranasal vaccines and
methods of vaccination are available, they may not always be
completely effective or safe. Also, cattle do not always respond
uniformly immunologically to any vaccination. The range of immune
responses can vary from no response at all to a very high level of
response when such cattle are treated with the same batch of
vaccines.
[0012] Vaccine failure is caused by many different factors,
including the immune status of the animal, the environment in which
the animal lives or the vaccine is administered, the specific
pathogen, and improper administration. Eliminating or reducing the
factors that contribute to vaccine failure is a significant issue
for all farmers who manage herds because their economic livelihood
depends on having healthy and productive animals. Because the
farmer or professional veterinarian is often working in low light
conditions, and are often interrupted when attempting to vaccinate
their animals, one form of improper administration that occurs is
administration of the vaccine after it is no longer viable. This
can greatly reduce or entirely eliminate the effectiveness of the
vaccine. Additionally, some vaccines combination vaccines or other
mixtures have a short time period in which they remain viable once
mixed, reconstituted or removed from refrigerated storage.
[0013] Furthermore, farmers often work with their animals in the
early morning or under the poor lighting conditions of a barn. Farm
animal vaccinations are often done in the winter when the animals
are indoors which acerbates the low light conditions. In either
case, the visibility of a vaccine bottle and/or the septa in the
serum cap by which a syringe needle accesses the vaccine bottle
contents is important. Poor visibility can lead to a need-stick or
other adverse consequences for the farmer, veterinarian, or the
animal.
[0014] Because it is impossible to determine if a vaccine or
immunogenic composition is still viable after reconstitution,
mixing or removal from refrigerated storage based on visual
examination, a need exists to enable a farmer, veterinarian, or
other end-user to make this determination in a simple, easy, and
effective manner. Additionally, a need exists to assist the
end-user in seeing and administering a vaccine to an animal under
poor or low light conditions.
[0015] The present invention is generally directed to packages that
preferably include at least one medicament therein. Particularly
preferably, the term "package" covers a container system or one or
more containers of such container system or a packaging thereof or
related thereto. Thus, the terms "package" and "container" can be
replaced where not explicitly indicated to the contrary.
[0016] The packages preferably include at least one light member
affixed thereto that is capable of emitting light upon activation.
In many embodiments as described herein, the light member is
activated upon the opening of the package or any step up to the way
of preparing a mixture of the contents of the containers of the
container system such that upon opening or said step, the light
member fluoresces or otherwise emits light to provide information
to the ambient or to an end user.
[0017] In some embodiments, the light generated by the light member
allows the end user to locate and utilize the package in dark
conditions.
[0018] In other embodiments, the light generated by the light
member may be configured such that it is emitted only for a time
period equal to the viability time period of the medicament or
mixture contained within the package to alert an end user when the
medicament or mixture is no longer useable.
[0019] In still other embodiments, the light generated by the light
member may be configured such that it changes color at a time
period equal to the viability time period of the medicament or
mixture contained within the package to alert an end user that the
medicament or mixture is no longer useable.
[0020] The present disclosure preferably is directed to a package
comprising: (i) preferably a medicament, and (ii) a light member.
The light member preferably is located on the exterior of the
package, and/or is configured to provide information to the ambient
or to an end user through the emission of light.
[0021] The present disclosure is further directed to a method for
determining the viability of a medicament in a package. The method
comprises (i) activating a light member on the package, preferably
comprising said medicament, when the package is opened or when any
step up to the way of preparing a mixture of the contents of the
containers of the container system forming or comprising the
package is conducted; and (ii) preferably observing the
fluorescence in the light member.
[0022] The present disclosure is further directed to a method for
determining the viability of a medicament or mixture in a package.
The method comprises: (i) opening the package and/or conducting a
step directly related to mixing contents, (ii) activating a light
member located on the package containing the medicament or mixture
such that the light member emits fluorescent light; and (iii)
preferably observing a change in color in the light member over a
period of time.
[0023] A first aspect the present invention relates to a container
system having at least two containers. The container system
comprises a light member which is configured to provide
information, preferably to an end user to the ambient and/or
visible from the outside, through the emission of light. The
container system is configured to provide information through the
emission of light--preferably automatically--when a step which is
directly related to preparation of a mixture of contents of or
substances stored inside the containers is conducted.
[0024] Alternatively or additionally, the container system
generally is configured to provide information through the emission
of light.
[0025] Using the emission of light for providing a user with
information enables secure usage of the system or mixtures prepared
using the system particularly in dark areas like barns. Further, by
means of the lighting member the information is emphasized.
Accordingly, the information is less likely overseen or
ignored.
[0026] Preferably, the container system is configured to provide
information through the emission of light--preferably
automatically--when a fluidic connection is prepared between the
containers. In particular, the container system is configured to
activate the light member to emit light or to change properties of
light emitted by the light member when the fluidic connection is
prepared between the containers.
[0027] The containers preferably each comprise a connecting
arrangement. The connecting arrangements are configured for the
preparation of the fluidic connection between the containers,
preferably wherein the connecting arrangements are configured to
prepare the fluidic connection by insertion of one connecting
arrangements into the other and/or by twisting the connecting
arrangements relative to one another.
[0028] Alternatively, or additionally, the container system is
configured to provide information through the emission of
light--preferably automatically--when the containers are separated
from one another. The containers can be stored, provided or be
initially in a transporting position releasably connected to one
another. The container system preferably is configured
to--preferably automatically--activate the light member to emit
light or to change properties of light emitted by the light member
when the containers are separated from one another while the
containers keep closed.
[0029] Both separating the containers and connecting them by means
of the fluidic connection can form steps of the process for mixing
contents or substances stored inside of the containers. Generally,
any step which is directly related to preparing of the mixture of
contents or substances stored inside the containers is can be used
to control or trigger the lighting member.
[0030] As the container system is configured to enable mixing up
the contents of the containers and the mixture prepared from the
contents can be used, it is advantageous to provide the information
at the time of or immediately prior to preparation of the mixture.
This can be achieved by triggering the light member to emit light
or to change properties of light emitted by the light member.
[0031] The information provided to the end user preferably is
related to the viability of a medicament or mixture which can be
prepared by mixing up contents of the containers.
[0032] In one aspect of the present invention, the light member is
configured to emit light for a predetermined period of time or to
change properties of light emitted by the light member after a
predetermined period of time. Particularly preferably, said period
of time corresponds to or complies with the period of time for
which the medicament or mixture remains viable.
[0033] As already indicated, a mixture of substances can have a
limited viability, for example due to physical, chemical or
biological processes affecting active substances within the mixture
and there can be a period of time, starting from the point in time
where the mixture is produced and ending where the viability cannot
be guaranteed any more, referred to as viability or viability time
span. The viability in particular can be based on or influenced by
potential contamination, oxidation, coagulation or interaction of
the substances.
[0034] By means of the light member triggered by a step performed
at the time or for enabling mixing the contents of the containers,
the present invention provides an indicator for the viability or
that the mixture is not viable anymore which is easy to be
identified, even under dark conditions. Further, the emitted light
can be registered by an end user directly or by means of reflected
or scattered light even in cases where one container of the
container system is inserted into an administration device like an
injector or a syringe.
[0035] The light emission preferably is produced by fluorescence,
chemiluminescence, or a light emitting diode. Alternatively, or
additionally, the light member uses passive illumination, active
illumination or a combination thereof.
[0036] Preferably, the light member is activated by the combination
of two or more chemicals. Said chemicals preferably are separated
from one another and the container system is adapted to cause the
chemicals to come into contact when the step related to mixing the
contents is conducted, when the fluidic connection is prepared
and/or when the container are separated.
[0037] The light member preferably is part of the exterior
adornment of the container system or one or more of the containers
of the container system. This facilitates to attract attention
directly and without loss of light intensity when the light member
is covered, which, however, is possible as well.
[0038] A further aspect of the present invention, which can be
realized independently as well, relates to a method for determining
the viability of a medicament or mixture which is prepared by
mixing contents of at least two containers using a fluidic
connection between said containers, wherein information is provided
through the emission of light when a step which is directly related
to preparation of a mixture of contents of or substances stored
inside the containers is conducted.
[0039] Preferably, information is provided through the emission of
light when the containers are separated from one another or when a
fluidic connection is prepared between the containers or when a
different step directly related to preparing a mixture of contents
of the containers is conducted.
[0040] Alternatively, or additionally, the containers each comprise
a connecting arrangement configured for the preparation of the
fluidic connection between the containers, wherein the light member
is--preferably automatically--activated when the fluidic connection
between the containers is prepared.
[0041] Preferably, activating the light member comprises causing
two or more precursor chemicals to mix and/or exposing the light
member to light for at least a set time period. Such precursor
chemicals in the following are also referred to as chemical
components.
[0042] In one aspect of the present invention, the light member
emits light for a period of time or changes a lighting property
after said period of time. Said period of time preferably is equal
to the length of time for which the medicament or mixture remains
viable or is pre-known or predetermined to be viable.
[0043] A color change of the light emitted by the light member can
occur or the light member can stops emitting light at the time when
the medicament or mixture become non-viable or is considered
non-viable due to expiry of a minimum predetermined shelf life.
[0044] This period of time preferably complies with a minimum shelf
life or durability of the mixture that can be obtained by mixing up
the contents of the containers and/or the mixture preferably is
considered to be non-viable when the minimum shelf life or
durability of the mixture has expired. Thus, the period of time can
be the time span the mixture is deemed to be viable.
[0045] As already indicated, the container system comprises at
least two containers, preferably bottles. The containers preferably
comprise connecting arrangements configured to provide for a
(continuous) fluidic connection between containers.
[0046] The containers can be fluidically connected to one another
by means of the connecting arrangements, so that the substances are
mixed together, particularly to form the combined vaccine. During
or by preparing this fluidic connection, the lighting member can
(automatically) be triggered. In particular, the lighting member is
automatically triggered when the connecting arrangements are docked
to one another, inserted into one another, and/or rotated relative
to one another. It is not necessary that the fluidic connection is
completed for triggering the lighting member. It might be
sufficient to perform one step on the way to establish the fluidic
connection to trigger the lighting member.
[0047] Triggering the lighting member according to the present
invention preferably means activating the lighting member to emit
light. Alternatively, or additionally, starting a time span after
which the a stop or start of limit emission, or after which
properties of the emitted light are (automatically) changed visibly
to an end user can be understood as triggering the lighting member.
Said time span preferably is or complies with the period of time
the mixture is or is deemed viable.
[0048] One or both of the containers can comprise a removal opening
in addition to the connecting arrangements, the removal opening(s)
being re-closeable and configured to remove the substance or
mixture from the container(s). The removal opening can be or
comprise a septum.
[0049] The first container can comprise a first substance,
particularly a first vaccine against a first disease, while a
second container comprises a second substance, particularly a
second vaccine against a second disease different from the first,
for the preparation of a mixture of substances, particularly for
the preparation of a combined vaccine for simultaneous immunization
against different diseases. However, the containers can comprise
different substances as well.
[0050] In the sense of the present invention the terms "substance"
and "content" (as stored in said containers in an initial state)
are used exchangeably and can be replaced unless indicated to the
contrary. Said substances or contents can comprise a medicament, an
active substance of a medicament, a liquid, a dry substance like a
lyophilisate, said substances or contents can be or be a
medicament, an active substance of a medicament, a liquid, a dry
substance like a lyophilisate or can be configured to form a
medicament when mixed.
[0051] The containers preferably comprise substances that, when
mixed, have a limited viability, preferably in the sense as
previously explained.
[0052] The containers and/or the connecting arrangements preferably
are fluidically sealed in an initial state or prior to connecting
them fluidically. After the fluidic connection has been prepared,
the containers have a joint inner room covering the substances
which can be mixed, thus forming the mixture.
[0053] The connecting arrangements preferably each comprise an
opening region, in particular being unstable, frangible and/or
having a predetermined breaking point/line.
[0054] In one aspect, the first connecting arrangement preferably
is deformable outside the opening region and is configured so that
the deformation opens the first connecting arrangement in the
opening region. This deformation can be effected by the second
connecting arrangement. Alternatively, the first connecting
arrangement can be pierced by the second connecting arrangement to
provide the fluid connection. Said deformation or the first or
second connecting arrangement during or by means of the deformation
process can trigger the lighting member.
[0055] The first connecting arrangement has a preferably rigid
closure device, particularly a closure plate, which is sealingly
held on a holding portion of the connecting arrangement in an
initial state by means of a frangible point/line, particularly a
fragile thin point/line, the holding portion being movable relative
to the closure device by deformation, as a result of which the
first connecting arrangement can be opened by breaking,
particularly tearing/cracking, the frangible point/line.
[0056] The first connecting arrangement preferably comprises a
severing element, particularly a piercing element and/or cutting
edge, by means of which the second connecting arrangement can be
opened. The deforming device preferably corresponds to the holding
portion, formed in particular by a mouth-shaped portion
[0057] The connecting arrangements can be sealingly inserted in one
another and, when the connecting arrangements are rotated relative
to one another, the first connecting arrangement can be opened, as
a result of deformation of the holding portion by means of the
deforming device, in order to produce the fluidic connection.
[0058] The second connecting arrangement preferably comprises a
deforming device for opening the first container by means of the
first connecting arrangement by deforming the holding portion.
[0059] Preferably the first connecting arrangement is configured
for opening the other, second connecting arrangement. It is also
preferable that the second connecting arrangement should be
configured for opening the first connecting arrangement. Any step
of the opening processes can be used for triggering, can come along
with triggering or can automatically trigger the lighting
element.
[0060] The connecting arrangements preferably are configured to
produce the fluidic connection by mutual opening, the first
connecting arrangement opening the second connecting arrangement
and the second connecting arrangement opening the first connecting
arrangement, thus producing the fluidic connection.
[0061] The connecting arrangements are preferably formed to be
complementary and/or to correspond to one another, preferably such
that the fluidic connection can--preferably only--be produced with
connecting arrangements that fit one another.
[0062] The connecting arrangements are preferably fluidically
sealed in each case in an initial state. This makes it possible to
produce a mixture as required or on the spot, and to use containers
which each comprise the respective connecting arrangements, but
also to use them separately or independently of one another.
[0063] The connecting arrangement or arrangements is or are
preferably designed for one-time and/or irreversible opening,
particularly with or by means of the opening region or regions. An
opening formed with or by means of or in the connecting system is
thus preferably not reclosable.
[0064] An opening is unreclosable or is irreversibly openable in
the sense of the present invention particularly when it can only be
reclosed using special tools and/or by replacing defective parts or
adding new parts. A destroyed sealing film as a preferred form of
an opened opening region is preferably deemed to be unreclosable or
irreversibly openable in the sense of the present invention even
when the destroyed sealing film could theoretically be replaced and
re-instated using corresponding equipment.
[0065] The proposed connecting system is hereinafter explained in
more detail by reference to two connecting arrangements, the first
connecting arrangement and the second connecting arrangement. This
does not necessarily imply an opening sequence but serves primarily
to differentiate the connecting arrangements. It is thus
particularly possible to produce the second connecting arrangement
separately and independently from the first connecting
arrangement.
[0066] The connecting arrangements are preferably different and/or
are configured differently for opening the other respective
connecting arrangement. Thus, preferably, different mechanisms are
used for opening the different connecting arrangements, or the
connecting arrangements are designed for this purpose.
[0067] The embodiments may also be combined with one another, for
example, by first opening the opening region of the first
connecting arrangement with the second connecting arrangement by
means of a severing element, then opening the second opening region
of the second connecting arrangement by piercing the second opening
region with the first connecting arrangement and subsequently
further opening the opening region of the first connecting
arrangement with the second connecting arrangement by deforming the
first connecting arrangement with the second connecting
arrangement. Each of these processes/steps might trigger the
lighting element.
[0068] The connecting arrangements may also mutually pierce one
another and/or one of the connecting arrangements may pierce the
other connecting arrangement and the other connecting arrangement
may open the one connecting arrangement by a deformation process.
Each of these processes/steps might trigger the lighting
element.
[0069] The proposed container system is particularly preferably
used for the combined administration of medicaments. In particular,
it is possible to store vaccines as contents which are not stable
in the long term with one another in separate containers and to
connect these containers fluidically by means of the proposed
connecting system before use, thus enabling a rapid and efficient
formation of a mixture, without affecting removal openings such as
septa. Alternatively, the respective vaccines may also be used
separately from one another through the removal openings, if no
fluidic connection has been formed by means of the connecting
system.
[0070] Containers or bottles and/or connecting arrangements in the
sense of the present invention are preferably at least
substantially dimensionally stable, rigid or semi-rigid and/or at
least substantially formed from plastics material, or plastics
material comprising, in particular, polyethylene, HD-PE, LD-PE or
polypropylene.
[0071] A "bottle" in the sense of the present invention is
preferably a closable container for transporting and storing
fluids, particularly liquids, gases and pourable solids such as
powders. A bottle in the sense of the present invention preferably
has a diameter which is smaller than its height. A bottle in the
sense of the present invention preferably has an at least
substantially conically tapering end, also referred to as the neck
of the bottle. The neck of the bottle preferably ends in an opening
which is, in particular, round, closable and openable for the
removal of its contents, also referred to as the removal opening.
Bottles in the sense of the present invention are preferably
narrow-necked bottles and/or vials. In narrow-necked bottles the
diameter or the internal width of the removal opening is less than
the average internal diameter of the storage space formed by the
bottle, preferably less than 70%, particularly less than 50%.
However, other solutions are also possible here.
[0072] A "connecting arrangement" in the sense of the present
invention is preferably a device which is configured to provide the
fluidic connection and, preferably, to provide a mechanical
connection while forming the fluidic connection. In particular, it
is a fluid coupling, a flange, a coupling member, an attachment
member, a plug connection, a male and/or female connector,
particularly a plug connector, or a part thereof.
[0073] A "connecting arrangement" in the sense of the present
invention may be a portion/region of a container, particularly a
bottle, or the connecting arrangement is (in each case) connected
to a container, particularly by material, frictional and/or
interlocking connection. Particularly preferably the connecting
arrangement is at least partially formed by or in one piece with
the container or the bottle. Alternatively or additionally the
connecting arrangement adjoins a container or a bottle or is
otherwise suitable for fluidically attaching or connecting the
interior of the container or the bottle.
[0074] A connecting arrangement is preferably "fluidically sealed",
in the sense of the present invention, when the escape or passage
of fluid, particularly liquid, is prevented or when a fluid or
liquid barrier prevents the escape or passage of fluid,
particularly liquid.
[0075] Connecting arrangements are "insertable in one another" in
the sense of the present invention particularly when a part or
portion of one of the connecting arrangements can be arranged
inside the other connecting arrangement or a part or portion
thereof. In particular, at least a portion of one of the connecting
arrangements can be pushed, laid, inserted or otherwise introduced
into the other or corresponding connecting arrangement. Connecting
arrangements are inserted in one another particularly when they
overlap radially at least partially, substantially or completely in
relation to a (common) axis of symmetry and/or central axis, or an
inner portion of the one connecting arrangement is (completely)
surrounded or embraced (radially) by an outer portion of the other
connecting arrangement.
[0076] An "axial movement" along a common axis in the sense of the
present invention is preferably a movement which is non-helical,
non-rotational, at least substantially or solely linear and/or
solely axial and/or a movement which does not require a complete
rotation or revolution. The connecting arrangements are preferably
adapted to be fitted into one another, inserted in one another
and/or fitted together in an at least substantially linear manner
to produce the non-releasable and/or fluidic connection.
[0077] "Opening" in the sense of the present invention particularly
denotes providing access to the interior of a container or a bottle
or the volume contained by a container or bottle, by forming an
opening, an orifice, a passage, a hole or the like, particularly so
that a fluid, particularly a liquid, can enter and/or leave.
[0078] An "opening region" in the sense of the present invention is
in particular a region which is configured for opening, i.e., is
constructed so as to form an opening, an orifice, a passage, a hole
or the like or fluidic access for the interior or for the volume
contained by a container. The opening region is preferably
fluidically closed and fluidically openable. It may be a closed off
hole, a closed and openable wall orifice, a closed and openable
passage, a closed and openable closure or the like.
[0079] A "film-like opening region" is preferably a portion which
is particularly of thin-walled or flat construction to form an
opening. A film-like opening region is preferably an opening/region
which is sealed or closed off by a film, membrane, or other flat,
thin, breakable and/or fragile structure.
[0080] "Pierceable" in the sense of the present invention is, in
particular, a structure which can be broken through or perforated
by means of an object, particularly a point, so that a connection
can be made from one (flat) side to the opposite side. The piercing
preferably produces an opening. In particular, a pierceable opening
region is destroyed on piercing and permanently opened thereby.
[0081] "Sealing" in the sense of the present invention indicates in
particular that the escape and/or ingress of substances is
prevented by a barrier.
[0082] "Self-sealing" in the sense of the present invention denotes
in particular that a sealing action is produced without separate
aids, with intrinsic means and/or automatically, fully
automatically, coincidentally or without the need for any separate
steps.
[0083] "Sterile self-sealing" in the sense of the present invention
denotes, in particular, self-sealing, thereby forming a barrier
against the ingress of germs such as bacteria or viruses, so as to
at least substantially prevent the ingress and/or escape of
bacteria. In particular, the seal, the sealing clearance and/or
contact pressure are designed so that any leaks that may
potentially remain have a maximum cross section which blocks the
passage of germs such as bacteria or viruses.
[0084] "Fluid-tight" in the sense of the present invention is in
particular a seal which at least substantially prevents the
entrance or exit of fluids, particularly liquids.
[0085] "Gas-tight" in the sense of the present invention is, in
particular, a seal which at least substantially prevents the
entrance or exit of gases.
[0086] A "material construction" in the sense of the present
invention denotes in particular a composition and/or a structure
and/or a morphology and/or an arrangement of different structures,
different materials or the like.
[0087] A "laminar construction", also a sandwich construction,
multi-layered construction, particularly a composite construction,
a composite material and/or a laminated compound material in the
sense of the present invention denotes in particular a structure
comprising different layers which are preferably joined together
and/or adjoining one another, can be logically sub-divided or
delimited from one another, are arranged with their flat sides
facing one another or arranged against one another, comprising flat
elements or portions which can be differentiated by their physical
or chemical properties.
[0088] "At the edges" in the sense of the present invention or an
"edge portion" in the sense of the present invention is in
particular a region spaced from a center, middle or center of
gravity, or a region which has an edge, a margin, an end or a
boundary, adjoins the latter or faces the latter. In particular, it
is a portion of a preferably flat structure at its circumferential
edge, in particular of an encircling or annular shape or the
like.
[0089] A "central portion" in the sense of the present invention
is, in particular, a portion at a spacing from an end, edge and/or
margin, and/or comprises, encompasses or extends around a center, a
middle point or center of gravity.
[0090] "Destroying the opening region" in the sense of the present
invention denotes in particular the irreversible changing of the
opening region, thereby impacting its previous function as a seal,
wall, sealing member and/or closure or so that the previous
function is no longer performed, particularly as a result of
machining, shaping, deformation, tearing, separation or by some
other method. The opening region may be opened and/or the fluidic
connection may be produced thereby.
[0091] "Cutting through the opening region" in the sense of the
present invention denotes in particular severing the material of
the opening region from one side to another, particularly an
opposite side, and/or dividing them and/or severing them by
cutting, shearing, piercing or some other method.
[0092] "Remaining intact" in the sense of the present invention
denotes in particular the maintenance of a previously existing
function. An intact opening region has and retains, in particular,
the function or functions of closing off, sealing and/or forming a
barrier against the ingress and/or escape of germs, fluids,
liquids, gases or the like.
[0093] A "fluid" for the purposes of the present invention is
preferably a flowable substance. A fluid is particularly flowable
such that it is able to pass through a fluidic connection. In
particular, a fluid for the purposes of the present invention is a
liquid, a suspension, a flowable solid, such as a powdered or
granulated material, and/or a gas in liquid or gaseous form.
Particularly preferably, at least one of the substances is liquid,
particularly both or at least two substances.
[0094] A "fluidic connection" in the sense of the present invention
is preferably an arrangement configured for the passage of a fluid,
particularly a liquid, a gas or a flowable solid. In particular, it
is a transit region, a passage or channel.
[0095] A "fluidic passage" in the sense of the present invention is
in particular a means which is configured for the passage of a
fluid, particularly a liquid, a gas or a flowable solid. In
particular, it is a transit region, a connection or a channel which
is preferably (tightly) sealed off from the environment or a side
remote from the passage on a wall that forms the passage.
[0096] Preferably, an opening region in the sense of the present
invention is "brittle" if, particularly on account of its
composition and/or construction, it is suitable for and designed to
tear close to its elastic limit without or with very little plastic
deformation (brittle facture). In particular, the opening region
has an elastic limit of less than 200 N/mm.sup.2 and/or a tensile
strength of less than 100 N/mm.sup.2, preferably less than 60
N/mm.sup.2 and/or a quotient of elastic limit and tensile strength
of less than 1, preferably less than 0.7 or 0.5. This can be
achieved in particular by structuring and/or combining, joining or
laminating different materials. The opening region may be formed by
a laminate of several films, of which preferably one film contains
aluminum or consists of aluminum or is metallic. Particularly
preferably, the opening region is at least partly metallic.
Preferably, the opening region is formed with or from a composite
material which preferably has a preferably flat or film-like layer
of aluminum.
[0097] An "unstable opening region" in the sense of the present
invention is preferably a region which is mechanically less stable
than the parts surrounding it and/or which can be destroyed
manually or by the application of force, particularly in the manner
of a frangible point.
[0098] "Outside the opening region" in the sense of the present
invention means that this is a region or portion which is separate
from the opening region but is preferably directly or indirectly
adjacent to the opening region, particularly such that deformation
in this region causes stretching of the opening region.
[0099] "Deformable" in the sense of the present invention is
preferably elastic or plastic deformability. The connecting
arrangement(s) or mouth-shaped portions are preferably elastically
deformable, thus causing plastic/irreversible deformation of the
opening region. The connecting arrangement(s) or mouth-shaped
portions may, however, also be plastically deformed/deformable.
[0100] Parts or portions are said to "corresponding to one another"
in the sense of the present invention particularly when they are of
similar and/or complementary construction to one another, when they
fit into one another, resemble one another, are arranged similarly,
have similarly oriented structures of similar shape and/or are
configured to interact with one another in order to produce a
function or effect.
[0101] "Rotating relative to one another" in the sense of the
present invention denotes in particular a rotary movement of a
part, preferably a connecting arrangement or a container or a
bottle with a connecting arrangement, relative to another part,
preferably another connecting arrangement or another container or
another bottle.
[0102] "Rotating relative to one another" in the sense of the
present invention denotes in particular a rotary movement of two
parts, preferably a connecting arrangement or a container or a
bottle with a connecting arrangement, relative to another part,
preferably another connecting arrangement or another container or
another bottle, preferably in different or opposite directions of
rotation.
[0103] A "mouth-shaped portion" in the sense of the present
invention is in particular a portion or part which comprises or
forms an opening, an opening edge, a mouth or a neck, preferably
with an opening at its end, or some other tubular portion or a
passage with a radially surrounding wall which terminates in an
opening, which is preferably open at its end and/or forms an
opening at at least one end.
[0104] In the sense of the present invention the term "thin walled"
denotes in particular a structure which is flat or planar in cross
section with a wall thickness on average less than 2 mm, 1.5 mm, 1
mm and/or less than 0.5 mm or 0.3 mm, particularly preferably less
than 200 .mu.m, particularly less than 150 .mu.m.
[0105] A "closure device" in the sense of the present invention is
preferably a part of, or at least substantially forms, an opening
region. The closure device here is, in particular, a flat or planar
arrangement or closure plate. Thus, a closure device has, in
particular, a material thickness that exceeds its longitudinal
extent, preferably by a factor of at least 2, 3, 4 or 5.
[0106] The closure device is preferably formed in one piece,
particularly in one piece with the frangible point, particularly
the thin point. The closure device together with the frangible
point may form an opening region or a part thereof. Preferably, the
frangible point forms the film-like, brittle and/or unstable part
of the opening region or renders the opening region film-like,
brittle and/or unstable. For this reason, the frangible point is
preferably sufficiently fragile to form an opening by tearing under
mechanical load.
[0107] The connecting arrangement is preferably formed from
plastics, particularly a thermoplastic material, particularly by
injection molding. The opening region is preferably predominantly
formed by the closure device, particularly over more than 70%, 80%,
90% or 95% of its area. Thus, compared with the surface area of the
closure device, the frangible point takes up an area of less than
10%, particularly less than 5%.
[0108] The closure device may be S-shaped in cross-section
longitudinally of the main dimension. The closure device may have
ribs or other reinforcing elements to stiffen it. The closure
device is preferably sufficiently stable or rigid that it cannot be
deformed, or can only be deformed to an insignificant degree, by
the frangible point. The result of this is that a force acting on
the frangible point does not deform the closure device or deforms
it only insignificantly, particularly by compression, thus ensuring
that the frangible point breaks or tears more easily.
[0109] A "frangible point", particularly a thin point, in the sense
of the present invention is preferably a film-like, brittle and/or
instable or fragile area or opening region or a film-like, brittle
and/or unstable or fragile part of the opening region. The
frangible point can be a predetermined breaking point. It is not
limit to a point but can also be a frangible line, frangible area,
predetermined breaking line and/or predetermined breaking area.
[0110] The frangible point is preferably embodied and designed to
be broken or torn by mechanical stress in order to form an opening.
In particular, the frangible point interacts with the closure
device, while the frangible point can be tensioned relative to the
closure device in such a way that the resulting tensions, shear
forces and the like lead to breakage of the frangible point. The
frangible point thus is or forms, in particular, a weakened point
or a portion with a mechanically weakened structure compared with
surrounding or adjacent areas.
[0111] The frangible point is preferably provided completely or
partly circumferentially at or within the mouth-shaped portion or
holding portion. The frangible point may be in the shape of a bead
or web. In particular, the frangible point forms a connecting strip
to the closure device, particularly from the holding portion or
mouth-shaped portion.
[0112] A "chamber" in the sense of the present invention is
preferably a structure or volume which is tightly sealed or
sealable in all directions. The chamber may, however, be openable
in principle, for example by a connecting arrangement or by opening
a sealing arrangement or the like.
[0113] A "volume" or "volume formed" in the sense of the present
invention preferably denotes a region or a (partial) chamber which
is at least substantially or entirely surrounded. The term "volume"
may thus be replaced by the term chamber or partial chamber, if
required. Moreover, a distinction is made between an inner volume
and an outer volume; preferably, this is functionally intended to
convey that the inner volume can be reached by passing through the
outer volume. Preferably, the outer volume surrounds the inner
volume. However, this is not absolutely essential, as in other
embodiments the outer volume may form an antechamber to the inner
volume. Preferably, the outer volume forms an outwardly sealed
antechamber, while the inner volume is adjacent to the outer volume
and is sealed off from it, so that the outer volume shields the
inner volume from the environment.
[0114] A "container blank" in the sense of the present invention is
preferably a tubular structure with at least two openings, one
opening being or forming a removal opening for later opening and/or
closing or filling and/or removal. Another opening is of a
temporary nature and is sealed off during the manufacturing process
of the container, particularly preferably by the leaktight use or
incorporation of a connecting arrangement. The connecting
arrangement as such can then form part of the container and enable
later opening of the container in the region.
[0115] A "container blank" in the sense of the present invention
comprises the opening for the insertion or fitting of a connecting
arrangement, preferably on a side which is opposite or remote from
the removal opening. However, other solutions are also possible. In
addition, a container blank may also comprise only one opening for
insertion or fitting of the connecting arrangement. In this case,
the container obtained after assembly has only one opening in the
form of the opening region of the connecting arrangement. The
container blank preferably comprises a bottle-like site which has
an at least substantially conically tapering portion or shoulder
region which transitions into a bottle neck. The bottle neck then
preferably forms, or comprises, the removal opening.
[0116] A "sealing portion" in the sense of the present invention is
preferably a region which is configured and/or arranged for sealing
abutment. In particular, it is a sealing lip, a sealing strip or
the like. A sealing portion may comprise a sealing surface which is
formed by a surface region of the sealing portion and provides the
direct sealing effect. In particular, a sealing effect is achieved
by means of sealing surfaces bearing directly on one another. For
this purpose, the sealing surfaces preferably bear on one another
under tension or pressure, for example in the form of a press fit
or the like. The sealing surfaces are preferably formed by the
material of the sealing portion or the surface of the sealing
portion. However, there are also other possibilities, for example
using seals in the region of the sealing portion.
[0117] A "support portion" in the sense of the present invention
preferably interacts with an opening region or a frangible point
such that opening of the opening region or breaking or tearing of
the frangible point, by mixed-mechanical support, support from
below, particularly acting as a bearing or counter-bearing, is
avoided. In particular, this is thus a device which diverts or
keeps mechanical stress away from fragile, unstable areas, so as to
impede or prevent accidental opening. The support portion is
particularly configured to relieve stress from the frangible
point.
[0118] A "securing device" in the sense of the present invention is
preferably a means for preventing movements, particularly relative
movements of connecting arrangements and/or containers, or other
actuations which would or could lead to the opening of an opening
region. In particular, it is a securing ring or the like, for
blocking a, preferably axial, movement of connecting arrangements
to one another and to enable such movement during actuation or
removal. The securing device preferably comprises a blocking part
which, as a working part or working portion of the securing device,
is directly responsible for a blockade, particularly of a movement,
being implemented or removed.
[0119] A "guide device" in the sense of the present invention is
preferably a mechanism or a part thereof which guides a relative
movement of connecting arrangements to one another, particularly
bayonet-like. This preferably enables a bayonet connection to be
obtained. A bayonet connection, also known as a bayonet closure,
preferably is a mechanical connection of two at least substantially
cylindrical and/or rotationally symmetrical parts, particularly
rotationally symmetrical with respect to a central axis or axis of
symmetry.
[0120] The connection is produced by means of the guide devices by
a pushing in and turning movement. Parts are inserted axially in
one another and after being pushed in axially until they reach a
stop they are rotated relative to one another, thus producing an
interlockingly engaging blockade in the axial direction. This
preferably produces the fluidic connection.
[0121] A "first guide device" for this purpose is preferably a
slot, a groove or other guide device with an at least substantially
right-angled configuration, beginning with a part that extends
axially or parallel to the central axis or axis of symmetry, and an
adjoining part which extends at least substantially at right-angles
to the previous direction. The portion that follows the axially
extending portion thus extends preferably at least substantially in
a plane perpendicular to the central axis or axis of symmetry.
Another or second guide device, and/or guide device corresponding
to the first, is preferably a button, peg, strip or other part
corresponding to the other guide device, thus corresponding
particularly to the groove, slot or the like. Overall, the guide
devices thus preferably form a sliding guide.
[0122] The containers are preferably produced separately from one
another for the provision of the fluidic connection. This enables
them to be universally applicable.
[0123] In the following specification and claims, reference will be
made to a number of terms, which shall be defined to have the
following meanings. The singular forms "a," "an," and "the" include
plural references unless the context clearly dictates otherwise.
The terms "comprising," "including," and "having" are intended to
be inclusive and mean that there may be additional elements other
than the listed elements. "Optional" or "optionally" means that the
subsequently described event, structure, or circumstance may or may
not occur, and that the description includes instances where the
event, structure or circumstance occurs and instances where it does
not.
[0124] Approximating language, as used herein throughout the
specification and claims, may be applied to modify any quantitative
representation that could permissibly vary without resulting in a
change in the basic function to which it is related. Accordingly, a
value modified by a term or terms, such as "about,"
"approximately," and "substantially," are not to be limited to the
precise value specified. In at least some instances, the
approximating language may correspond to the precision of an
instrument for measuring the value. Here and throughout the
specification and claims, range limitations may be combined and/or
interchanged; such ranges are identified and include all the
sub-ranges contained therein unless context or language indicates
otherwise.
[0125] Various embodiments of the disclosure are discussed
throughout this application. Any embodiment discussed with respect
to one aspect of the disclosure applies to other aspects of the
disclosure as well, and vice versa. Each embodiment described
herein is understood to be embodiments of the disclosure that are
applicable to all aspects of the disclosure. It is contemplated
that any embodiment discussed herein can be implemented with
respect to any method or composition of the disclosure, and vice
versa.
[0126] Unless defined herein and below in the remainder of the
specification, all technical and scientific terms used herein have
the same meaning as commonly understood by one of ordinary skill in
the art to which the disclosure pertains.
[0127] The term "animal" as used herein refers to any animal which
is the subject of a medical treatment for a medical condition
unless stated otherwise. In some instances the medical treatment
may be prophylactic instead of reactive (e.g., a vaccine to prevent
a medical condition rather than a medication to treat an already
existing medical condition). It is understood that at least
domestic animals, farm animals, zoo animals, sport animals and pet
animals are within the scope of the meaning of the term. Desirably,
the animal is a farm animal. Examples of farm animals include, but
are not limited to, horses, cows, pigs, buffalo, bison, oxen,
chickens, goats, sheep, donkeys, alpacas, llamas, rabbits, dogs,
cats, ducks, and turkeys.
[0128] The terms "medicament", "medication", and "medicine" are
used interchangeably herein and describe a pharmaceutical
composition or product intended for the treatment or prevention of
a medical condition having at least one symptom. The pharmaceutical
composition or product will have a physiological effect on the
animal when it is introduced into the body of an animal. The
pharmaceutical composition or product can be in any suitable
formulation unless a specific formulation type is required or
disclosed.
[0129] "Immunologically protective amount" or "immunologically
effective amount" or "effective amount to produce an immune
response" of an antigen is an amount effective to induce an
immunogenic response in the recipient. The immunogenic response may
be sufficient for diagnostic purposes or other testing, or may be
adequate to prevent signs or symptoms of disease, including adverse
health effects or complications thereof, caused by infection with a
disease agent. Either humoral immunity or cell-mediated immunity or
both may be induced. The immunogenic response of an animal to an
immunogenic composition may be evaluated, e.g., indirectly through
measurement of antibody titers, lymphocyte proliferation assays, or
directly through monitoring signs and symptoms after challenge with
wild type strain, whereas the protective immunity conferred by a
vaccine can be evaluated by measuring, e.g., reduction in clinical
signs such as mortality, morbidity, temperature number, overall
physical condition, and overall health and performance of the
subject. The immune response may comprise, without limitation,
induction of cellular and/or humoral immunity. "Immunogenic" means
evoking an immune or antigenic response. Thus an immunogenic
composition would be any composition that induces an immune
response.
[0130] "Therapeutically effective amount" refers to an amount of an
antigen or vaccine that would induce an immune response in a
subject receiving the antigen or vaccine which is adequate in
preventing or reducing the clinical signs or symptoms of disease,
including adverse health effects or complications thereof, caused
by infection with a pathogen, such as a virus or a bacterium.
Humoral immunity or cell-mediated immunity or both humoral and
cell-mediated immunity may be induced. The immunogenic response of
an animal to a vaccine may be evaluated, e.g., indirectly through
measurement of antibody titers, lymphocyte proliferation assays, or
directly through monitoring signs and symptoms after challenge with
wild type strain. The protective immunity conferred by a vaccine
can be evaluated by measuring, e.g., reduction in clinical signs
such as mortality, morbidity, temperature number, overall physical
condition, and overall health and performance of the subject. The
amount of a vaccine that is therapeutically effective may vary
depending on the particular adjuvant used, the particular antigen
used, or the condition of the subject, and can be determined by one
skilled in the art.
[0131] An "immunogenic or immunological composition" and/or
"vaccine" preferably refers to a composition of matter that
comprises at least one veterinary antigen and/or immunogenic
portions thereof that elicit an immunological response in the host
of a cellular or antibody-mediated immune response to the
composition. In some desirable embodiments, an immunogenic
composition induces an immune response and, more desirably, confers
protective immunity against one or more of the clinical signs of at
least one veterinary antigen.
[0132] The terms "vaccination" or "vaccinating" or variants
thereof, as used herein means, but is not limited to, a process
which includes the administration of a vaccine and/or an
immunogenic composition that, when administered to an animal,
elicits, or is able to elicit--directly or indirectly--, an immune
response in the animal against at least one veterinary infectious
disease.
[0133] As used herein, the term "viable" or any variants thereof,
when used in reference to a medicament preferably means that the
medicament when administered to a patient in need thereof produce
an immune response in said patient. It does not require that the
immune response be the maximum possible or therapeutically
effective. Both humoral and cell-mediated immune response are
covered, and a viable medicament may produce either a humoral
immune response, a cell-mediated immune response or both. If the
medicament is a vaccine or immunogenic composition, the immune
response may be partial or complete protection from the medical
condition, and the protection may be permanent or temporary.
[0134] The light member as discussed further herein may use both
fluorescence and/or chemiluminescence. Both result from the decay
of a molecule in a higher energy or excited state back down to the
ground state. This decay results in the release of energy and the
emission of a photon; however, they are caused by different
phenomenon. Fluorescence results from electronic excitation--a
consequence of the molecule absorbing a photon initially. That is,
a photon of light is absorbed and re-emitted. The same color may or
may not be re-emitted as the molecule can lose energy, while in the
excited state, through vibrational deactivation.
[0135] Chemiluminescence is caused by a molecular reaction of two
(or more) ground state molecules producing a final molecule in an
excited state. The energy in the reactants is translated into the
products and, while forming the products, it also excites them.
This excitation may lead to chemiluminescence. Some reactions also
result in the formation of molecules in an excited state that
result in the emission of a photon of light.
[0136] As a non-limiting example of chemiluminescence, Glow
Sticks.RTM. emit light in any of various different colors based on
the combination of three different chemicals: diphenyl oxalate,
hydrogen peroxide and a fluorescent dye according to the following
reaction:
##STR00001##
[0137] The selection of the fluorescent dye determines the color of
the excited dye which is the source of the light emission observed
by the end-user. Non-limiting examples of fluorescent dyes are
rhodamine B (red), 5,12-bis(phenylethynyl)naphthacene (orange),
rubrene (yellow), 9,10-bis(phenylethynyl)anthracene (green), and
9,10-diphenylanthracene (blue). In the initial structural
arrangement, the hydrogen peroxide is physically separated from the
diphenyl oxalate and dye. Upon the application of force to the Glow
Stick (i.e., bending it which ruptures the separator), the diphenyl
oxalate and dye mix with the hydrogen peroxide thereby initiating a
cascade which ultimately leads to the excitation of the dye,
thereby causing the emission of light. Other chemiluminescent
reactions are known in the art and that emit light as required in
the embodiments disclosed herein are acceptable.
[0138] Alternatively, the light source of the light member may be
generated by a light emitting diode (LED). An LED is a
semiconductor device that emits visible light, usually
monochromatic, when an electric current passes through it. In such
a configuration, the light member comprising the LED would have an
actuation switch that includes at least two different actuation
settings such that the LED could be turned on and off. In some
embodiments, the light member using an LED would be removable from
the package and transferable to another package. In some other
embodiments, the light member using an LED would be single use and
disposed after use.
[0139] In another embodiment, the emission of light is actuated by
removal of a separator that prevents two or more chemical from
mixing. Upon removal, the chemicals mix thereby causing a chemical
reaction that emits light.
[0140] The color of the light emitted from the light member is not
limited and may be selected from any color visible to the human
eye. Examples include, but are not limited to, white, red, orange,
yellow, green, blue, indigo and violet. Different shades and
intensities are also not limited. In some embodiments, the color is
desirably yellow or white. They are selected based on the desired
characteristics of the light member. Additionally, more than one
color may be emitted from a light member over time.
[0141] In another embodiment, the light emitted by a chemical
reaction may be one color, but the packaging structure or exterior
containment comprising the chemicals may be a different color
thereby exhibiting a different color to the end-user. As a
non-limiting example, a chemiluminescent reaction that emits white
light can be encased in a plastic structure where the exterior of
that plastic structure is green. The end user would see a green
light rather than a white one. The color of the structure that
encases the chemicals is not limited and may be selected as desired
by the manufacturer of the package. As one non-limiting example,
some manufactures have trademarks that comprise a specific color or
combination of colors. The color of the encasement of the chemicals
could be matched to that color or combination of colors thereby
enhancing brand recognition.
[0142] Regardless of the source of the light, fluorescence,
chemiluminescence or an LED, they are observationally
identical--visible light is emitted that is observed by an
end-user. Additionally, because fluorescence and chemiluminescence
are so similar in their source and often confused for one another,
these two terms are used interchangeably. The embodiments disclosed
herein are related to the outwardly observed visual effect rather
than the cause of that effect.
[0143] The aspects of the present invention mentioned above and
described in the following specific description may also be
implemented and advantageous individually and in various
combinations.
[0144] Further details, advantages and properties of the present
invention will become apparent from the following description of
preferred embodiments with reference to the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0145] FIG. 1 shows a longitudinal section through a container
system with the proposed connecting system and with the fluidic
connection made;
[0146] FIG. 2 shows a longitudinal section through the proposed
connecting system in a first embodiment in a starting position;
[0147] FIG. 3 shows a longitudinal section through the proposed
connecting system of the first embodiment in a first connecting
position;
[0148] FIG. 4 shows a longitudinal section through a proposed
connecting system of the first embodiment in a second connecting
position;
[0149] FIG. 5 shows a longitudinal section through a proposed
connecting system in a second embodiment in a starting
position;
[0150] FIG. 6 shows a longitudinal section through the proposed
connecting system in the second embodiment in a first connecting
position;
[0151] FIG. 7 shows a longitudinal section through the proposed
connecting system in the second embodiment in a second connecting
position with the connecting arrangements oriented with one
another;
[0152] FIG. 8 shows a longitudinal section through the proposed
connecting system in the second embodiment in the second connecting
position with the connecting arrangements rotated relative to one
another about a common axis;
[0153] FIG. 9 shows a schematic plan view of a first container with
a first connecting arrangement for the proposed connecting system
of the second embodiment;
[0154] FIG. 10 shows a schematic plan view of a second container
with a second connecting arrangement for the proposed connecting
system of the second embodiment;
[0155] FIG. 11 shows a schematic cross-section through the proposed
connecting system in the second embodiment along the section line
XI-XI in FIG. 7;
[0156] FIG. 12 shows a schematic cross-section through the proposed
connecting system in the second embodiment after partial rotation
of the connecting arrangements relative to one another;
[0157] FIG. 13 shows a schematic cross-section through the proposed
connecting system in the second embodiment along the section line
XIII-XIII in FIG. 8;
[0158] FIG. 14 shows a schematic longitudinal section through a
container with connecting arrangements according to the first
embodiment on opposite sides;
[0159] FIG. 15 shows a perspective view of a container with a
second connecting arrangement of the proposed connecting system in
the first embodiment;
[0160] FIG. 16 shows a schematic longitudinal section through the
proposed container system with the proposed connecting system
according to the first embodiment in a transporting
configuration;
[0161] FIG. 17 shows a schematic longitudinal section through a
first container with a first connecting arrangement covered in
sterile or sterilizable manner;
[0162] FIG. 18 shows a schematic longitudinal section through the
first container according to FIG. 17 with the cover device
removed;
[0163] FIG. 19 shows a schematic longitudinal section through the
first container held like a foot in the cover device according to
FIG. 17;
[0164] FIG. 20 shows a schematic longitudinal section through the
second container with the closure partially removed;
[0165] FIG. 21 shows a schematic longitudinal section through the
proposed container system, indicating the direction of movement for
providing the fluidic connection with the proposed connecting
system;
[0166] FIG. 22 shows a schematic longitudinal section through a
container system according to a further embodiment in the connected
state;
[0167] FIG. 23 is one embodiment where the light member is on the
serum cap of a package;
[0168] FIG. 24 is one embodiment where the light member is
integrated into the label of a package;
[0169] FIG. 25 is one embodiment where the light member is a sleeve
that fits around two separate packages that comprise a
medicament;
[0170] FIG. 26 is one embodiment where the light member is a sleeve
that fits over a package;
[0171] FIG. 27 is one embodiment where the light member is a sleeve
that fits over a package;
[0172] FIG. 28 is one embodiment where the light member is attached
to the serum cap of a package;
[0173] FIG. 29 is one embodiment where the light member is attached
to the bottom of a package;
[0174] FIG. 30 is one embodiment where the light member is attached
to the side of a package;
[0175] FIG. 31 is one embodiment where the light member is a sleeve
that fits around a serum cap on a package;
[0176] FIG. 32 is one embodiment where the light member is a sleeve
that fits over a package and includes an LED light source;
[0177] FIG. 33 is one embodiment where the light member is a cap
that fits over the serum cap of a package and includes an LED light
source; and
[0178] FIG. 34 is one embodiment where the light member is a ring
that fits around a pair of packages that comprise a medicament and
includes an LED light source.
DETAILED DESCRIPTION OF THE INVENTION
[0179] In the following description of preferred embodiments by
reference to the drawings, the same or corresponding reference
numerals (with or without an apostrophe) have been used for the
same or similar components or parts, where similar or identical
advantages and properties may be achieved even if the associated
description has not been repeated.
[0180] FIG. 1 shows in schematic section a proposed container
system B with a first container B1 and a second container B2.
[0181] The container system B preferably comprises a proposed
connecting system 1. The connecting system 1 is preferably
configured to produce a fluidic connection 2, preferably between
the first container B1 and the second container B2 of the container
system B.
[0182] The connecting system 1 preferably comprises a number of
connecting arrangements 3A, 3B, particularly a first connecting
arrangement 3A which is associated with a first container B1 of the
container system B and/or a second connecting arrangement 3B which
is associated with the second container B2 of the container system
B. Preferably, the first container B1 comprises the first
connecting arrangement 3A and the second container B2 comprises the
second connecting arrangement 3B or vice-versa.
[0183] The containers B1, B2 are preferably used for storing
substances S1, S2, particularly for storing a first fluid and a
second fluid and/or different vaccines. In particular, the
containers B1, B2 are wholly or partly filled with one or more
different substances S1, S2 or vaccines. Alternatively, or
additionally the container or containers B1, B2 may also hold
and/or store other substances S1, S2, preferably a solid. It is
possible for only one substance S1, S2 to be a fluid, particularly
a liquid. The fluid substance S1, S2 may be configured to form a
solution or a suspension with the other substance S1, S2.
[0184] The proposed container system B is preferably used to
prepare a medicament, particularly a combined medicament, combined
vaccine or the like. However, there are other possible and
advantageous applications for the proposed container system B.
[0185] Preferably, the first container B1 comprises a removal
opening E1 and/or the second container B2 comprises a removal
opening E2. Particularly preferably, both or at least two
containers B1, B2 of the proposed container system B each comprise
a removal opening E1, E2.
[0186] A removal opening E1, E2 in the sense of the present
invention is preferably configured to dispense or to make it
possible to remove the contents of the respective container B1,
B2.
[0187] At least one and preferably several or all of the removal
openings E1, E2 are preferably repeatedly useable, utilizable
several times, re-sealable, re-usable and/or comprise a closure
element V1, V2 which preferably allows opening and closing for the
purpose of stepwise removal. This may be achieved by means of a
septum.
[0188] Preferably, the removal openings E1, E2 are closed or
closable and/or are primary means for removing substance S1, S2
from the containers B1, B2.
[0189] In the embodiment shown, preferably at least one of the
removal openings E1, E2 and particularly both removal openings E1,
E2 are closed off by so-called septa. A septum is a device with a
rubber-like closure element V1, V2, particularly a rubber stopper
or injection stopper, which is suitable for piercing by means of an
injection needle for removal of its contents, the septum
automatically closing the (respective) removal opening E1, E2 by
elastic resilience after the injection needle has been removed. A
septum, also referred to as a piercing membrane, preferably has a
thin area, particularly in the center, this thin area being
suitable for piercing in order to take up injection liquid using an
injection needle. The injection stopper or the septum is preferably
secured to the neck of the bottle or the removal opening E1, E2 by
means of a flanged cap, preferably made of aluminum.
[0190] Preferably, one, both or all the containers B1, B2 are
(each) injection ampoules or vials, for example, so-called
multi-dose containers, particularly for vaccinating a number of
animals with one dose each.
[0191] In the containers B1, B2, substances S1, S2 in the form of
powdered medicaments, solutions or suspensions or vaccines may be
transferred in this form.
[0192] The containers B1, B2 may (each) have a capacity of more
than 10 ml, preferably more than 50 ml, 100 ml or 200 ml and/or
less than 2 liters, preferably less than 1.5 liters or 1 liter,
particularly less than 750 ml (each or after connection).
[0193] As shown in FIG. 1, the closure element V1, V2 is preferably
sealingly connected to the respective removal opening E1, E2,
preferably pressed on, particularly by means of a pressing ring or
compression ring or a flanged cap. However, other solutions are
also possible here, for example an adhesive bond, welded joint, a
connection produced by injection molding or the like.
[0194] It is certainly preferable that the containers B1, B2 of the
proposed container system B should each have a removal opening E1,
E2, but not all the containers B1, B2 of the container system B
must have a removal opening E1, E2.
[0195] Advantageously, the use of removal openings E1, E2 on a
number of containers B1, B2 makes it possible to use the respective
substance S1, S2 from the respective container B1, B2 independently
of the use of the connecting system 1. Advantageously, the
container system B therefore allows both separate use of the
containers B1, B2 and also their use in conjunction with the
fluidic connection 2 provided by the connecting system 1.
[0196] The containers B1, B2 are preferably fluidically connectable
to one another so that the fluidic connection 2 between the volumes
formed or held by the containers B1, B2 results in a joint interior
being formed by the containers B1, B2 connected by the connecting
system 1. The joint interior is particularly characterized in that
the continuous fluidic connection 2 has a hydraulic cross section
of more than 2 square millimeters, preferably more than 5 or 10
square millimeters, particularly more than 1, 2 or 3 square
centimeters, or there is no constriction between the containers B1,
B2, once the fluidic connection 2 has been made, which falls below
such a hydraulic cross section or wherein the fluidic connection 2
has at least such a hydraulic cross section.
[0197] The container or containers B1, B2 is or are preferably
configured as bottles. Particularly preferably, the containers B1,
B2 (each) comprise a bottle neck F1, F2 which forms the removal
openings E1, E2 or is adjacent thereto. A bottle neck F1, F2 may,
starting from a terminal edge or mouth of the removal opening E1,
E2, encompass an enlargement of the (hydraulic) cross section by
more than a factor 1.5, particularly by more than a factor 2 or
2.5. However, the removal openings E1, E2 may also be differently
constructed.
[0198] The containers B1, B2 preferably comprise the removal
opening E1, E2 and the connecting arrangement 3A, 3B at different,
opposite, diametrically opposed sides, ends, axial ends and/or in
the neck region on the one hand and in the base region on the other
hand. In particular, the removal opening E1, E2 is formed by the
bottle neck F1, F2 and the connecting arrangement 3A, 3B is
provided in the base region or at the opposite end from the bottle
neck F1, F2. This has proved advantageous as it ensures that, when
the connecting arrangements 3A, 3B are used, the removal opening(s)
E1, E2 remain(s) accessible and unaffected in its (their)
function.
[0199] The connecting arrangements 3A, 3B are preferably not
intended for removal but for a one-time or irreversible provision
of a durable fluidic connection 2, or are not reclosable.
[0200] The present invention is explained by means of the
particularly preferred use for connecting to containers B1, B2,
particularly bottles. However, it is possible and advantageous to
use the proposed connecting system 1 in other areas as well, for
example for fluidically connecting a container B1, B2 to other
systems, for example for the rapid removal of the substance S1,
S2.
[0201] FIG. 2 shows in longitudinal section a proposed connecting
system 1 according to the first embodiment in a starting position
or in the unconnected state.
[0202] FIG. 3 shows in longitudinal section the proposed connecting
system 1 according to the first embodiment in a first connecting
position in which preferably the fluidic connection has not yet
been made but one of the opening regions 4A, 4B has already been
opened.
[0203] FIG. 4 shows in longitudinal section a proposed connecting
system 1 according to the first embodiment in a second connection
position in which a fluidic connection 2 is produced. This is the
position which is also shown in FIG. 1.
[0204] The proposed connecting system 1 preferably comprises a
plurality of connecting arrangements 3A, 3B, particularly
preferably at least the first connecting arrangement 3A and the
second connecting arrangement 3B, which are preferably configured
to be at least partially complementary to one another or
corresponding to one another.
[0205] The first connecting arrangement 3A preferably comprises an
opening region 4A. The second connecting arrangement 3B preferably
comprises an opening region 4B.
[0206] Preferably, the containers B1, B2 comprise the opening
regions 4A, 4B or the opening regions 4A, 4B form a part of the
respective connecting arrangement 3A, 3B which is associated with
the respective container B1, B2 or forms a part thereof.
[0207] Preferably, one or both opening regions, 4A, 4B are regions
or portions of the respective connecting arrangement 3A, 3B which
are configured to produce the fluidic connection 2 (durably and/or
irreversibly), particularly by (irreversible) destruction thereof.
For this purpose the opening region or regions 4A, 4B may have a
(mechanical) weakened area or frangible point or may be configured
as a weakened area or frangible point. The opening regions 4A, 4B,
may be identical, similar or different in construction,
particularly with respect to the reduced material and/or the shape
of the opening regions 4A, 4B.
[0208] In particular, the opening regions 4A, 4B are configured to
be (mechanically) destroyed or pierced in order to provide the
fluidic connection 2. For this purpose an opening region 4A, 4B
according to the present invention may be configured to be
destroyed, perforated and/or torn open under mechanical load in
order to enable or produce the fluidic connection 2.
[0209] In the embodiment shown, the opening regions 4A, 4B are
formed by film-like or membrane-like wall portions of the
respective connecting arrangement 3A, 3B. In particular, one or
more of the opening regions 4A, 4B is or are sealing films. In
principle, the opening regions 4A, 4B may, however, be formed by
weakening the material that forms the respective connecting
arrangement 3A, 3B and/or may be formed in one piece with the
respective connecting arrangement 3A, 3B.
[0210] The opening region or regions 4A, 4B are preferably
configured to tear when mechanically stressed and thereby produce
the fluidic connection 2. Preferably, the opening regions 4A, 4B
have a material with a modulus of elasticity of more than 2000
N/mm.sup.2, preferably more than 4000 N/mm.sup.2, particularly more
than 6000 N/mm.sup.2. Alternatively or additionally, the opening
regions 4A, 4B may have a tensile strength of less than 100
N/mm.sup.2, preferably less than 80 N/mm.sup.2, more particularly
less than 60 N/mm.sup.2. The modulus of elasticity and the tensile
strength may be determined according to EN ISO 6892-1, ISO 6892,
ASTM E 8, ASTM E 21, DIN 50154, DIN 50125 and/or ISO 527, ASTM D
638.
[0211] It is also preferable that the opening region or regions
should have a material thickness of less than 100 .mu.m, preferably
less than 70 .mu.m, particularly less than 50 .mu.m and/or more
than 5 .mu.m, particularly more than 10 .mu.m.
[0212] The first connecting arrangement 3A, 3A' preferably
comprises the first, particularly film-like, opening regions 4A,
4A' and/or the second connecting arrangement 3B, 3B' preferably
comprises a second, particularly film-like opening region 4B, 4B'.
Advantageously, this simultaneously ensures secure closure 14 of
the respective connecting arrangements 3A, 3A', 3B, 3B' and
reliable and simple opening of the respective opening regions 4A,
4A', 4B, 4B'.
[0213] The first connecting arrangement 3A, 3A' is preferably
configured to open the second connecting arrangement 3B, 3B' by
piercing or destroying the second opening region 4B, 4B'.
Alternatively, or additionally the second connecting arrangement
3B, 3B' is preferably configured to open the first connecting
arrangement 3A, 3A' by piercing or destroying the first opening
region 4A, 4A'. Advantageously, the fluidic connection 2 may thus
be produced manually or without the use of tools. The interiors of
the containers B1, B2, B3 are preferably connectable by means of
the connecting arrangements 3A, 3A', 3B, 3B' without any further
aids or tools.
[0214] Preferably, to produce the fluidic connection 2, the opening
region 4A, 4A', 4B, 4B' of the second connecting arrangement 4B,
4B' may be pierced with the first connecting arrangement 4A, 4A'
and preferably the first opening region 4A, 4A' of the first
connecting arrangement 3A, 3A' may be pierced with the second
connecting arrangement 3B, 3B', particularly a severing element 7
thereof. The fluidic connection 2 may thus be produced by mutual
perforation or piercing.
[0215] The connecting arrangements 3A, 3A', 3B, 3B' preferably have
mouth-shaped portions 5A, 5A', 5B, 5B', which are formed such that
the mouth-shaped portion 5A, 5A', 5B, 5B' of one of the first and
second connecting arrangements 3A, 3A', 3B, 3B' may be aligned with
the mouth-shaped portion 5A, 5A', 5B, 5B' of the other one of the
first and second connecting arrangements 3A, 3A', 3B, 3B', so that
preferably the opening region 4A, 4A', 4B, 4B' of the other one of
the first and second connecting arrangements 3A, 3A', 3B, 3B' can
be pierced and/or the other one of the first and second connecting
arrangements 3A, 3A', 3B, 3B' can be opened.
[0216] The opening region 4A preferably comprises the mouth-shaped
portion 5A and/or the opening region 4B comprises the mouth-shaped
portion 5B. The mouth-shaped portions 5A, 5B preferably delimit the
opening regions 4A, 4B. The mouth-shaped portions 5A, 5B may be
formed in one piece with and/or as a wall portion of the respective
connecting arrangement 4A, 4B. Preferably, the mouth-shaped
portions 5A, 5B have open edges or are formed in the shape of
collars or necks, the respective opening region 4A, 4B preferably
being surrounded or delimited by the respective mouth-shaped
portions 5A, 5B. The mouth-shaped portions 5A, 5B or the open edges
thereof preferably adjoin the opening regions 4A, 4B or delimit
them, or vice-versa. Particularly preferably, an open edge of the
respective mouth-shaped portion 5A, 5B forms a (circumferential)
fixing portion for an opening region 4A, 4B which is more
particularly film-like or formed by a film.
[0217] The container system B, in another aspect of the present
invention which may also be implemented independently, comprises a
cover device 6 which is configured to hold one of the containers
B1, B2, particularly to act as a foot for it. Advantageously, the
cover device 6 may alternatively or additionally serve for,
particularly sterile, covering of one of the containers B1, B2
and/or one of the connecting arrangements 3A, 3B. This aspect will
be discussed in more detail hereinafter.
[0218] The connecting arrangement 3A, 3B and the method for
producing the fluidic connection therewith is explained in more
detail hereinafter in a first embodiment illustrated in FIGS. 2 to
5.
[0219] In the first embodiment, the first connecting arrangement 3A
is configured for opening the opening region 4B of the second
connecting arrangement 3B. It is particularly preferable that the
mouth-shaped portion 5A of the first connecting arrangement 3A
should be adapted to be inserted or pushed into the mouth-shaped
portion 5B of the connecting arrangement 3B such that during the
insertion or introduction the opening region 4B of the second
connecting arrangement 3B is opened.
[0220] In the embodiment shown, the first connecting arrangement
3A, 3A' or the first mouth-shaped portion 5A, 5A' is a preferably
male coupling element and/or the second connecting arrangement 3B,
3B' or the second mouth-shaped portion 5B, 5B' is a, preferably
female, coupling element, particularly forming a fluid
coupling.
[0221] In particular, it is provided that one end or an open edge
of the mouth-shaped portion 5A has an outer circumferential edge
which can be arranged inside an inner circumferential edge of the
mouth-shaped portion 5B.
[0222] Preferably, the outer circumferential edge of the
mouth-shaped portion 5A of the first connecting arrangement 3A
corresponds to the inner circumferential edge of the mouth-shaped
portion 5B of the second connecting arrangement 3B or resembles it,
or vice versa. In particular, the mouth-shaped portion 5A of the
first connecting arrangement 3A comprises, at least laterally or at
a transition to the opening region 5A, an external diameter which
is less than an internal diameter of the mouth-shaped portion 5B of
the second connecting arrangement 3B, preferably at least at a
terminal edge or at a transition to the opening region 5B. In the
embodiment shown in FIGS. 2 to 5, the mouth-shaped portion 5A, 5B
is preferably neck-shaped and/or at least substantially round in
cross section.
[0223] Unless otherwise stated, the term cross-section in the sense
of the present invention always refers to a section or a sectional
representation at right angles to the longitudinal axis or axis of
symmetry 9 of the respective container B1, B2 and/or the respective
connecting arrangement 3A, 3B.
[0224] The second connecting arrangement 3B of the first embodiment
preferably comprises a severing element 7 which is preferably
configured to pierce, sever, cut or generally destroy the opening
region 4A of the first connecting arrangement 3A. In particular,
the severing element 7 comprises or is formed by a piercing device,
a point, a blade, a wedge or generally a cutting and/or severing
device.
[0225] The severing element 7 is preferably arranged and/or
attached on the opening region 4B of the second connecting
arrangement, particularly directly. The severing element 7 is
preferably arranged on an outer side of the second connecting
arrangement 3B or on a side or outer side remote from the interior
of the container B2. The severing element 7 is preferably arranged
so that by bringing the connecting arrangement 3B of the severing
element 7 close to the opening region 4A of the first connecting
arrangement the severing element 7 applies a force to the opening
region 4A which leads to the destruction and opening of the opening
region 4A, preferably without opening or destroying the opening
region 4B of the second connecting arrangement 3B.
[0226] In particular, the severing element 7 is a device which
concentrates a force acting on the opening region 4A or distributes
a counter-force acting on the second connecting arrangement 3B or
on the opening region 4A such that the opening region 3B of the
second connecting arrangement 3B remains intact when the opening
region 4A is opened by being destroyed by the severing element
7.
[0227] In a variant (not shown) the severing element 7 is arranged
on an inner side of the connecting arrangement, within or inside
the interior of the container B1 or (viewed from outside) arranged
behind the opening region 3B of the second connecting arrangement
3B. Preferably, the opening region 4A, 4A' of the first connecting
arrangement 3A is destroyed by the severing element 7 as the
mouth-shaped portion 5A is pushed into the mouth-shaped portion 5B
of the second connecting arrangement 3B. For this purpose, the
severing element 7 is provided, particularly directly (on the
inside or on the side remote from the first connecting arrangement
3A) behind the opening region 4B of the second connecting
arrangement 3B.
[0228] Preferably, the severing element 7 is immovably arranged or
fixed on the second connecting arrangement 3B, particularly
(directly) on, in front of or behind the opening region 4A.
[0229] FIG. 2 shows the proposed connecting system 1 in a starting
position in which the opening regions 4A, 4B or the containers B1,
B2 are closed or sealed. In particular, they are (in each case)
bottles or bottle-like containers B1, B2, the bottom opening
regions 4A, 4B of which are closed in the starting position.
[0230] As shown by the arrow 8 indicating movement, the first
connecting arrangement 3A and the second connecting arrangement 3B
may be moved towards one another or pushed into one another. For
this purpose, the connecting arrangements 3A, 3B are preferably
moved axially towards one another with respect to a central axis or
axis of symmetry 9. The central axis or axis of symmetry 9 is
preferably a central axis or axis of symmetry 9 of the mouth-shaped
portion or portions 5A, 5B and/or of the opening region or regions
4A, 4B and/or of the container or containers B1, B2.
[0231] The containers B1, B2, the connecting arrangements 3A, 3B,
the opening regions 4A, 4B and/or the mouth-shaped portions 5A, 5B
may thus be formed substantially symmetrically with respect to the
central axis or axis of symmetry 9. An axially symmetrical and/or
rotationally symmetrical construction of the mouth-shaped portions
5A, 5B is preferred, as this enables the connecting arrangements
3A, 3B to be used independently of their rotary position. However,
other solutions are also theoretically possible, particularly ones
in which the mouth-shaped portions 5A, 5B are rotationally
asymmetrical or non-round and preferably a guide is provided which
is configured to define a rotary position of the connecting
arrangements 3A, 3B relative to the central axis or axis of
symmetry 9. This will be discussed in more detail in connection
with the second embodiment.
[0232] As can be seen in FIG. 3, as the connecting arrangements 3A,
3B come closer to one another the severing element 7 is applied to
the opening region 4A, preferably with a point 7A and by further
movement of the connecting arrangements 3A, 3B towards one another,
pushed through the opening region 4A. In this way the opening
region 4A is destroyed or the connecting arrangement 3A and/or the
container B1 is opened.
[0233] The connecting arrangements 3A, 3A', 3B, 3B' are preferably
designed to be separate and/or independent of one another in a
starting position (cf. also FIGS. 16 and 17). This advantageously
enables common and also separate use of cavities or containers B1,
B2, B3 which are connected to or connectable with the connecting
arrangements 3A, 3A', 3B, 3B'.
[0234] In the starting position, the connecting arrangements 3A,
3A', 3B, 3B' are preferably unconnected or fluidically separated
from one another. As a result of the formation of the fluidic
connection 2, the connecting arrangements 3A, 3A', 3B, 3B' move
into a connecting position in which the fluidic connection 2 is
made.
[0235] A fluidic connection 2 between the containers B1, B2, B3 is
preferably produced at least when the volumes or substances S1, S2,
S3 enclosed by the containers B1, B2, B3 are able to be moved
between the containers B1, B2, B3, by gravity and/or mixed with one
another.
[0236] The fluidic connection 2 is, in particular, a channel or a
passage through which fluid substances S1, S2, S3, particularly
liquids, can flow.
[0237] The connecting arrangements 3A, 3A', 3B, 3B' are preferably
usable only once and/or are irreversibly openable; the fluidic
connection 2 is preferably permanent and/or irreversible.
[0238] The connecting system 1 is preferably configured for the
provision of a non-releasable or non-separable connection,
particularly with the non-separable connection taking place even
before at least one of the connecting arrangements 3A, 3A', 3B, 3B'
has been opened. This prevents substances from escaping and
advantageously prevents a partial mixing process from taking
place.
[0239] The connecting arrangements 3A, 3A', 3B, 3B' preferably
comprise securing devices 10A, 10B for producing the non-releasable
connection, which produce a non-releasable connection between the
connecting arrangements 3A, 3A', 3B, 3B' as a result of being
fitted into one another and/or passed through one another by axial
movement along their shared axis. In particular, the securing
devices 10A, 10B comprise snap-fit hooks and/or are non-releasable
or self-securing by means of snap-fit hooks or a snap-fit hook
connection. In this way, it is possible to ensure that the
connection cannot be undone manually and/or without damage or
destruction.
[0240] The connecting arrangements 3A, 3A', 3B, 3B' can preferably
be connected to one another non-releasably or inseparably by
interlocking and/or frictional engagement, particularly by
latching. In particular, different connecting positions,
particularly latching positions, can be achieved by fitting one
inside the other and/or inserting one inside the other by axial
movement along the common axis.
[0241] In particular, one of the connecting arrangements 3A, 3A',
3B, 3B' comprises a latching means, particularly one or more
latching lugs, arranged on portions located axially behind one
another. Preferably, the latching means of one of the connecting
arrangements are arranged such that one or more complementary
latching means of the other connecting arrangement 3A, 3A', 3B,
3B', particularly one or more grooves or undercuts, latch into one
another to form an engagement by being fitted into one another
and/or inserted in one another with axial movement along the common
axis. This enables the non-releasable or inseparable connection or
the connecting position to be achieved.
[0242] The connecting arrangements 3A, 3A', 3B, 3B' are preferably
configured so that when a first connecting position is reached the
non-releasable or inseparable connection is made and/or none or
only one of the first and second connecting arrangements 3A, 3A',
3B, 3B' is or has been opened. The fluidic connection 2 is thus
preferably not yet or not entirely formed in the first latching
position.
[0243] When another, second connecting position is reached which is
preferably after the first connecting position in location and/or
time, the continuous fluidic connection 2 and/or the opening of the
two connecting arrangements 3A, 3A', 3B, 3B' is preferably
produced.
[0244] By bringing the first connecting arrangement 3A, 3A' and the
second connecting arrangement 3B, 3B' towards one another,
preferably first of all only one of the first and second opening
regions 4A, 4A', 4B, 4B' is broken, particularly pierced, and only
as the connecting arrangements 3A, 3A', 3B, 3B' are brought closer
together or subsequently rotated relative to one another or pushed
into one another, is the continuous fluidic connection 2 produced
by the breakage of the other one of the first and second opening
regions 4A, 4A', 4B, 4B'.
[0245] Preferably, the connecting system 1 has a first connecting
position in which the connecting arrangements 3A, 3B are connected
to one another non-releasably, preferably by latching. For this
purpose the connecting arrangements 3A, 3B may have securing
devices 10A, 10B corresponding to another which produce a
non-releasable connection between the connecting arrangements 3A,
3B as the connecting arrangements 3A, 3B are brought close
together.
[0246] In the embodiment shown, the securing devices 10A, 10B are
formed by corresponding or complementary undercuts, latching lugs
or the like. In particular, individual latching lugs are formed on
one of the connecting arrangements 3A, 3B, and in particular,
annular beads and/or undercuts are formed on the other of the
connecting arrangements 3A, 3B, which by co-operating provide a
latching connection between the connecting arrangements 3A, 3B.
[0247] Particularly preferably, the securing devices 10A, 10B are
configured for connecting the connecting arrangement 3A, 3B
non-releasably with one another in a first connecting position but
allowing further movement of the connecting arrangement 3A, 3B
towards one another.
[0248] Moreover, the securing devices 10A, 10B are preferably
configured so as to support a further, second connecting position
in which the connecting arrangements 3A, 3B are brought more
closely together or pushed further into one another than in the
first connecting position. Particularly preferably, a plurality of
latching positions are provided, in which, in a first latching
position, the connecting arrangements 3A, 3B are already
non-releasably connected to one another. The proposed connecting
system 1 is shown in this first connecting position in FIG. 3.
[0249] In the first connecting position, one of the connecting
arrangements 3A, 3B may already have been opened. Alternatively, or
additionally, the first connecting position may also be
characterized in that a non-releasable connection has indeed been
made between the connecting arrangements 3A, 3B but none of the
opening regions 4A, 4B has yet been opened or is being opened.
[0250] In the embodiment shown in FIG. 3, in the first connecting
position, the first connecting arrangements 3A are connected to the
second connecting arrangement 3B in non-releasable manner by
latching and the first opening region 4A has already been opened or
destroyed by the severing element 7.
[0251] FIG. 4 shows the proposed connecting system 1 in the second
connection position, particularly a further latching position, in
which the connecting arrangements 3A, 3B have been further brought
together and/or pushed further inside one another, particularly at
least substantially completely, compared with the first connecting
position. In the second connecting position the first opening
region 4A of the first connecting arrangement 3A has been opened by
the second connecting arrangement 3B and furthermore the opening
region 4B of the second connecting arrangement 3B has been opened
by the first connecting arrangement 3A.
[0252] In order to open the second connecting arrangement 3B with
or by means of the first connecting arrangement 3A, preferably the
mouth-shaped portion 5A of the first connecting arrangement 3A is
pushed through the opening region 4B of the second connecting
arrangement 3B, thereby destroying said opening region 4B. This is
preferably done as the connecting arrangements 3A, 3B are moved
from the first connecting position into the second connecting
position.
[0253] The securing devices 10A, 10B are preferably configured to
prevent (axial) movement of the connecting arrangements 3A, 3B away
from one another, both in the first connecting position and in the
second connecting position. Thus it is envisaged, in particular,
that the connecting arrangements 3A, 3B are movable further into
the second connecting position from the first connecting position
but not in an opposite direction. It is also preferable that the
connecting arrangements 3A, 3B in the second connecting position
(cf. FIG. 4) cannot be moved back into the first connecting
position.
[0254] Preferably, the connecting arrangements 3A, 3B abut on one
another, particularly sealingly, in the first connecting position.
This prevents substances S1, S2 from escaping.
[0255] According to an aspect of the present invention which can
also be implemented independently, during or as a result of the
opening of the opening region 4B of the second connecting
arrangement 3B by the mouth-shaped portion 5A of the first
connecting arrangement 3A, a seal is formed relative to the
environment. In particular, the opening region 4B of the second
connecting arrangement 3B forms a sealing system with the
mouth-shaped portion 5B of the second connecting arrangement 3B.
Alternatively or additionally, the mouth-shaped portions 5A, 5B may
have a sealing action by bearing against one another, while the
opening region 4B acts sealingly or provides a seal, particularly
at the edges and/or in the transitional area to the mouth-shaped
portion 5B. However, there are also other possible solutions, for
example using an additional or separate rubber seal, sealing lip or
the like.
[0256] The connecting arrangements 3A, 3B or the connecting system
1 is or are preferably formed without threads. It has been found
that systems known from the prior art which use threads to move a
cutting tool in order to open containers are more prone to defects
and require greater expense in order to create an opening or
fluidic connection. Advantageously, the connecting arrangements 3A,
3B of the present connecting system can be connected to one another
by a simple linear or axial movement and/or by moving directly
towards one another (without the need for any additional rotation
through several revolutions relative to one another). This has
proved advantageous for rapid and comfortable production of the
fluidic connection 2.
[0257] In this connection it is also advantageous that the proposed
connecting system 1 comprises one or more connecting positions,
particularly preferably in the form of latching positions. This has
the particular advantage over interlocking threads that a
non-releasable connection can be produced between the connecting
arrangements 3A, 3B. On the other hand, with a threaded connection,
dismantling and contamination are possible.
[0258] Theoretically, however, it is also possible to combine
aspects of the present invention with connecting arrangements 3A,
3B which are connected or connectable by interlocking threads or in
which the fluidic connection 2 can be produced by interlocking
threads and a rotational movement relative to one another.
[0259] FIGS. 5 to 13 hereinafter illustrate a proposed connecting
system 1 according to a second embodiment. Only the special
features and differences from the embodiments described above will
be discussed and therefore the foregoing remarks also apply in a
supplementary manner to the second embodiment unless specifically
stated to the contrary or obvious to the skilled man.
[0260] FIG. 5 shows in a starting position a first connecting
arrangement 3A' and a second connecting arrangement 3B' according
to the second embodiment. In the second embodiment, preferably none
of the connecting arrangements 3A', 3B' has a severing element. In
particular, the connecting system 1 according to the second
embodiment is free from cutting tools, severing mechanisms and/or
free from sharp edged projections or portions for opening.
[0261] In the second embodiment, mouth-shaped portions 5A' and 5B'
of the connecting arrangement 3A', 3B' are preferably configured to
be rotationally non-symmetrical or non-round, non-circular or oval
with respect to the central axis or axis of symmetry 9. Preferably,
the mouth-shaped portions 5A, 5B are configured to correspond to
one another and/or to be similar in relation to a circumferential
line, so that they can be arranged one inside the other and/or one
can be pushed into one another. Moreover, for supplementary
information, reference may be made to the explanations of the
mouth-shaped portions 5A, 5B in the first embodiment.
[0262] FIG. 6 shows the connecting arrangements 3A', 3B' in the
first connecting position in which they are connected to one
another, preferably non-releasably. For this, the securing devices
10A, 10B may be used as explained hereinbefore.
[0263] The connecting mean 3A', 3b' preferably comprise opening
regions 4A', 4B' which correspond to or resemble the opening region
in 4A, 4B of the first embodiment. In the first connecting position
according to FIG. 6, the opening regions 4A', 4B' abut on one
another or are directly adjacent to one another. Alternatively, in
the first connecting position, the opening region 4B' of the second
connecting arrangement 3B' may, however, also already have been
opened, as explained hereinafter in connection with FIG. 7.
[0264] For opening or penetrating the second opening region 4B',
the mouth-shaped portion 5A' of the first connecting arrangement
3A' is pressed through the opening region 4B' of the second
connecting arrangement 3B' as already explained in connection with
the opening of the opening region 4B of the first embodiment.
Preferably, the opening region 4B', particularly a sealing film or
a film-like portion of the second connecting arrangement 3B' is
destroyed or opened, particularly by pushing part of the first
connecting arrangement 3A' through the opening region 4B' so that
the opening region 4B' is opened or the film or the film-shaped
portion which forms the opening region 4B' is pierced or destroyed.
The result is shown in FIG. 7, in which, as a result of reaching
the second connecting position, the second connecting arrangement
3B has been opened in the manner described.
[0265] By contrast with the first embodiment, the method for
providing the fluidic connection 2 in the second embodiment begins
with the step of opening the second connecting arrangement 3B' by
means of the mouth-shaped portion 5A' or destroying the opening
region 4B' of the second connecting arrangement 3B' using the
mouth-shaped portion 5A'.
[0266] It is also envisaged in the second embodiment that the
connecting arrangements 3A', 3B' are rotatable relative to one
another or about the (common) central axis or axis of symmetry 9 in
their connected state, particularly in the second connecting
position. As a result, preferably the other of the connecting
arrangements 3A', 3b', i.e., the first connecting arrangement 3A',
in particular, is opened, as explained in detail hereinafter with
reference to FIGS. 8 to 13.
[0267] In one aspect it is preferable that the first opening region
4A, 4A', 4B, 4B' of the first connecting arrangement 4A, 4A' can be
opened by deformation by means of the second connecting arrangement
4B, 4B'. The opening regions 4A, 4A', 4B, 4B' can also be mutually
opened by mutual deformation. Opening by deformation preferably
does not require any shearing edges or severing elements, which is
advantageous in terms of a simple manufacturing process with
reduced use of materials.
[0268] The second connecting arrangement 3B, 3B' is preferably
configured to open the first connecting arrangement 3A, 3A', while
the second connecting arrangement 3B, 3B' is preferably configured
to open the opening region 4A, 4A', 4B, 4B' of the first connecting
arrangement 4A, 4A' by deformation of the first connecting
arrangement 3A, 3A'.
[0269] Particularly preferably, in this aspect, the deformation is
initiated by rotating the connecting arrangements 3A, 3A' relative
to one another, particularly about the common axis 9, and/or
opening the opening regions 4A, 4A' 4B, 4B' of the first connecting
arrangement 3A, 3A'.
[0270] The connecting arrangements 3A, 3A', 3B, 3B' preferably have
non-round, particularly oval or at least substantially elliptical
portions corresponding to one another which can be inserted in one
another and/or cause deformation and/or opening when rotated
relative to one another.
[0271] The deformation preferably brings about a tensioning of the
opening region 4A, 4A', at least substantially radially or
transversely with respect to a central axis or axis of symmetry 9
or along the opening region of the opening region 4A, 4A', as a
result of which the opening region 4A, 4A' is torn, broken or
detached and/or the opening region 4A, 4A' is opened.
[0272] At the same time, the second connecting arrangement 3B, 3B'
may have an, in particular film-like, brittle and/or unstable
opening region 4B, 4B', preferably with the first connecting
arrangement 3A, 3A' being configured for opening the second
connecting arrangement 3B, 3B'. In particular, the first connecting
arrangement 3A, 3A' is configured to open the second connecting
arrangement 3B, 3B' by breaking through the opening region 4B, 4B'
of the second connecting arrangement 3B, 3B'.
[0273] The first connecting arrangement 3A, 3A' preferably
comprises a mouth-shaped portion 5A, 5A' which adjoins the opening
region 4A, 4A' or surrounds the opening region 4A, 4A', the
mouth-shaped portion 5A, 5A' being deformable so that the opening
region 4A, 4B can be opened by the deformation.
[0274] The mouth-shaped portion 5A, 5A' is preferably in the form
of a web, a neck, a wall, a thin wall, or it is elastic and/or
flexible, and/or the mouth-shaped portion 5A, 5A' is more elastic,
more flexible and/or more stable than the opening region 4A, 4A',
which is preferably opened on deformation of the mouth-shaped
portion 5A, 5A' the opening region 4A, 4A', particularly by
tearing, breaking or detaching.
[0275] The second connecting arrangement 3B, 3B' is preferably
configured for deforming the mouth-shaped portion of the first
connecting arrangement 3A, 3A', so that the deformation causes the
opening region 4A, 4A' of the first connecting arrangement 3A, 3A'
to open.
[0276] The mouth-shaped portion 5A, 5A', 5B, 5B' is preferably
non-round, particularly oval, at least essentially elliptically
and/or polygonal in cross section, while the second connecting
arrangement 3B, 3B' has a corresponding cross section, so that
rotating the connecting arrangements 3A, 3A', 3B, 3B' relative to
one another causes deformation and/or opening of the first
connecting arrangement 3A, 3A' in their opening region 4A, 4A'.
[0277] Both connecting arrangements 3A, 3A' 3B, 3B' preferably have
mouth-shaped portions 5A, 5A', 5B, 5B' which can be arranged in
oriented manner inside one another or can be pushed into one
another, while rotation of the connecting arrangements 3A, 3A', 3B,
3B' or of the mouth-shaped portions 5A, 5A', 5B, 5B' relative to
one another brings about deformation of the first and, preferably,
the second mouth-shaped portion 5A, 5A', 5B, 5B'.
[0278] The connecting arrangements 3A, 3A', 3B, 3B' can be
connected to one another by a bayonet-type connection or they may
comprise connectors or guides 18A, 18B, which are configured to
form a bayonet-type connection. For this purpose, the mouth-shaped
portions 5A, 5A', 5B, 5B' may initially be pushed or capable of
being pushed (only) in the axial direction into one another and
only afterwards may they be rotated or rotatable relative to one
another, while preferably the fluidic connection 2 is not formed
until they are rotated relative to one another. The guides 18A, 18B
may thus be designed for a bayonet-type connection. For this
purpose, a (purely) axially extending guide may be adjacent to a
(purely) radial guide.
[0279] Preferably, by rotating the connecting arrangements 3A', 3B'
relative to one another while the mouth-shaped portion 5A' of the
first connecting arrangement 3A' is arranged in the mouth-shaped
portion 5B' of the second connecting arrangement 3B', the opening
region 4A' of the first connecting arrangement 3A' is mechanically
stressed, particularly tensioned by the deformation of the
mouth-shaped portion 5A' of the first connecting arrangement 3A' to
such an extent that it tears.
[0280] To improve the understanding of the opening mechanism for
opening the first opening region 4A' of the first connecting
arrangement 3A' from the second embodiment, FIGS. 9 and 10 each
show a plan view of a connecting arrangement 3A' 3B'. The second
connecting arrangement 3B' shown in FIG. 9 preferably has a
mouth-shaped portion 5B' which resembles the mouth-shaped portion
5A' of the first connecting arrangement 3A' shown in FIG. 10 in
shape and/or outline, but is larger in its dimensions, diameters,
longitudinal extent and/or transverse extent (at right angles to
the central axis or axis of symmetry 9).
[0281] In particular, the second connecting arrangement 3B'
comprises an inner circumferential edge 15--indicated by dashed
lines in the plan view in FIG. 9--which resembles an outer
circumferential edge 16 of the mouth-shaped portion 5A',
corresponds thereto and/or is configured so that the outer
circumferential edge 16 can be accommodated by the inner
circumferential edge 15. Preferably, a maximum diameter of the
inner circumferential edge 15 is greater than a maximum diameter of
the outer circumferential edge 16 and/or a minimum diameter of the
inner circumferential edge 15 is greater than a minimum diameter of
the outer circumferential edge 16, preferably by more than 2% or 3%
and/or less than 40%, preferably less than 30%, more particularly
less than 20%, 15% or 10%. This enables the mouth-shaped portions
5A', 5B' to be simply pushed one inside the other while at the same
time reliably opening the opening region 4A' of the first
connecting arrangement 3A'.
[0282] The mouth-shaped portions 5A', 5B' can preferably be
arranged inside one another or pushed into one another with play.
As a result of the arrangement of the mouth-shaped portions 5A',
5B' a gap 17 or a spacing is formed (at least partially) between
the inner circumferential edge 15 and the outer circumferential
edge 16.
[0283] In the embodiment shown, which relates to a particularly
preferred variant, the mouth-shaped portions 5A', 5B' are each oval
in cross section, particularly at least substantially elliptical.
Theoretically, however, other shapes are possible, for example at
least substantially square or other polygonal shapes. In theory it
is preferable that the extent of the cross section in the main
axial direction or the maximum extent in the secondary axial
direction (centrally and transversally or perpendicularly to the
main axial direction) exceeds or the minimum extent of the cross
section by a factor of more than 1.2, preferably 1.3, particularly
1.5, and/or at least or at least substantially by a factor root of
2. This allows sufficiently strong deformation during rotation of
the connecting arrangements relative to one another so that the
opening of the opening region 4A' of the first connecting
arrangement 3A' can take place reliably.
[0284] In FIGS. 11 to 13, the connecting arrangements 3A', 3B' are
shown in different rotational positions relative to one another,
preferably in the second connecting position.
[0285] Preferably, the connecting arrangements 3A', 3B' can be
turned or rotated through more than 45.degree. and/or less than
200.degree., particularly less than 135.degree. and/or at least
substantially through 90.degree., in their (non-releasably)
connected state or with the mouth-shaped portions 5A', 5B' inserted
in one another, about the (common) central axis or axis of symmetry
9. This ensures deformation of one or both mouth-shaped portions
5A', 5B' and/or opening of an opening region 4A', 4B', particularly
of the opening region 4A' of the first connecting arrangement
3A'.
[0286] In the embodiment shown in FIG. 8 the mouth-shaped portions
5A', 5B' are similar, particularly with reference to a
circumferential line radially of the central axis or axis of
symmetry 9, particularly so that after the first mouth-shaped
portion 5A' has been inserted or pushed into the second
mouth-shaped portion 5B' they rest loosely or with play on one
another or at least partially abut directly on one another
particularly at least at two points which are opposite one another
in respect of the central axis or axis of symmetry 9 and/or at
least 20%, preferably at least 50% of the respective
circumferential line.
[0287] Because of the rotationally asymmetrical or non-round form
of the mouth-shaped portions 5A, 5B, the rotation indicated by the
rotation arrows 11 results in force which has a deforming effect on
the first connecting arrangement 3A', particularly the mouth-shaped
portion 5A' thereof. In the embodiment shown, the mouth-shaped
portions 5A', 5B' are oval in cross section. This has proved
particularly advantageous as it ensures that during rotation the
mouth-shaped portions 5A', 5B' slide past one another without
snagging and ensures at least substantially continuous deformation
of the mouth-shaped portion 5B' of the second connecting
arrangement 3B' during the rotation of the connecting arrangements
3A', 3B' relative to one another. However, other rotationally
asymmetrical or non-round cross sections are also possible, such as
rectangles, polygons, triangles or the like.
[0288] FIG. 12 shows, in a schematic section through the connecting
system 1, particularly in the second connecting position, the
mouth-shaped portions 5A', 5B' in a position rotated through about
45.degree. to one another. The respective mouth-shaped portions
5A', 5B' generate forces on one another so as to produce
deformation of the mouth-shaped portion 5B' of the second
connecting arrangement 3B' and, preferably at the same time, a,
particularly corresponding, deformation of the mouth-shaped portion
5A' of the first connecting arrangement 3A'. As indicated by the
broken lines 12, the deformation of the mouth-shaped portion 5B'
leads to tensile and/or pressure stresses on the opening region 4B'
and, preferably, as a result, leads to fracture or opening.
[0289] FIG. 13 shows a schematic section through the connecting
system 1 as proposed, in which the first connecting arrangement 3A'
has been rotated through at least substantially 90.degree. relative
to the second connecting arrangement 3B'. Compared with the
rotation through about 45.degree. as shown in FIG. 12, the
increasing rotation of the connecting arrangements 3A', 3B'
relative to one another increases the tension or pressure and/or
tensile stress on the opening region 4B' such that the opening
region 4B' tears, breaks, becomes detached (at the edges) or opens
in some other way.
[0290] The connecting system 1 according to the second embodiment
preferably comprises a guide 18A, 18B (cf. FIGS. 9 and 10) for
connecting the connecting arrangements 3A', 3B' in a rotationally
oriented position or for determining a rotational position during
the connection thereof. In particular, a sliding guide or the like
is provided by means of which the connecting arrangements 4A', 4B'
or the mouth-shaped portions 5A', 5B' can only be fitted, placed or
pushed into one another in certain rotational positions (with
respect to the central axis or axis of symmetry 9), preferably such
that the mouth-shaped portions 5A', 5B' are similarly oriented.
[0291] The mouth-shaped portion 5A', 5B' are similarly oriented
particularly when main axes, longitudinal axes, transverse axes,
ends, corners and/or the like coincide with one another at least
substantially, particularly such that the first mouth portion 5A'
can be pushed into the second mouth portion 5B' at least
substantially without any deformation of the mouth portions 5A',
5B'.
[0292] The guide 18A, 18B is preferably configured such that in the
(second) connecting position or after the attachment of the
connecting arrangements 3A', 3B' or after the mouth-shaped portions
5A', 5B' have been inserted or pushed into one another, it is
possible to rotate these relative to one another, particularly
about the central axis or axis of symmetry 9. In particular, the
guide 18A, 18B comprises a slide or a portion which extends axially
or parallel to the central axis or axis of symmetry 9 and,
thereafter, has a radially extending portion, resulting in the
rotational movement described above. However, other solutions are
also possible.
[0293] The aspects of the first and second embodiment can also be
combined with one another. Thus, it is additionally possible for
the second connecting arrangement 3B, 3B' to comprise a severing
element 7 which at least partially opens the opening region 4A, 4A'
of the first connecting arrangement 3A, 3A' when the connecting
arrangements 3A, 3A', 3B, 3B' are placed inside one another. The
mouth-shaped portion 5A, 5A' can then be used to open, particularly
to pierce, the opening region 4B' of the second connecting
arrangement 3A, 3B'. Rotation of the connecting arrangements 3A,
3A', 3B, 3B' relative to one another about the central axis or axis
of symmetry 9 then leads to deformation of one or both mouth-shaped
portions 5A, 5A', 5B, 5B'. This leads to tensioning of the opening
region or regions 4A, 4A', 4B, 4B'. In this way, further breaking
and/or tearing of the opening region or regions 4A, 4A', 4B, 4B'
can advantageously be achieved, as a result of which the fluidic
connection 2 can be improved or the hydraulic cross section of the
fluidic connection 2 can be enlarged.
[0294] The connecting arrangements 4A, 4A', 4B, 4B' are preferably
configured for mutual opening and/or to complement and/or
correspond to one another, so that the continuous fluidic
connection 2 can be produced.
[0295] The connecting arrangements 3A, 3A', 3B, 3B' are preferably
configured in order to produce a hydraulic cross section of more
than 0.5 cm.sup.2, preferably more than 1 cm.sup.2 when producing
the fluidic connection 2. This permits rapid and total mixing.
[0296] The connecting arrangements 3A, 3A', 3B, 3B' are preferably
adapted to be axially inserted in one another, fitted into one
another and/or formed without threads. This allows rapid and simple
production of the fluidic connection 2.
[0297] By the production of the fluidic connection 2, the fluidic
connection 2 preferably forms a passage between the containers B1,
B2, B3 which is sealed off from the environment. This prevents the
ingress of foreign substances or germs.
[0298] The second connecting arrangement 3B, 3B' is preferably
configured to open the first connecting arrangement 3A, 3A' by
breaking through the first opening region 4A, 4A' and/or the first
connecting arrangement 3A, 3A' is configured to open the second
connecting arrangement 3B, 3B' by breaking through the second
opening region 4B, 4B'. By mutual destruction of the opening
regions 4A, 4A', 4B, 4B' it is advantageously possible to produce
an irreversible fluidic connection 2 of large enough diameter to
allow rapid mixing.
[0299] The connecting system 1 is preferably self-sealing, as a
result of the production of the fluidic connection 2, in particular
with at least one of the opening regions 4A, 4A', 4B, 4B' having a
sealing action as a result of or after the production of the
fluidic connection 2, so that the continuous fluidic connection 2
forms a passage sealed off from the environment. Preferably, the
production of the fluidic connection 2 forms a fluidic passage
which is sealed off from the environment, particularly in
fluid-tight, germproof and/or gas-tight manner.
[0300] For this purpose one of the opening regions 4A, 4A', 4B, 4B'
or a device forming the respective opening region, after being
perforated or otherwise destroyed as a sealing element,
particularly a sealing lip, may extend between the connecting
arrangements 3A, 3A', 3B, 3B' and in this way seal the connecting
arrangements 3A, 3A', 3B, 3B' with one another or relative to one
another.
[0301] The connecting system 1 is preferably self-sealing in
sterile or sterilizable manner as a result of the production of the
fluidic connection 2. In particular, the production of the fluidic
connection 2 produces a seal which prevents the ingress of
germs.
[0302] Preferably, in order to seal the connecting arrangements 3A,
3A', 3B, 3B' relative to one another, a seal, particularly a
sealing ring or sealing lip, is provided.
[0303] Particularly preferably, in order to seal the fluidic
connection 2, preferably from the environment, or to seal off the
fluidic passage, at least one opening region 4A, 4A', 4B, 4B',
preferably the second opening region 4B, 4B', acts as a seal, as a
result of or after the formation of the fluidic connection 2.
[0304] In particular, it is envisaged that the at least one opening
region 4A, 4A', 4B, 4B', preferably the second opening region 4B,
4B', has a sealing effect or acts as a seal at least at the edges
or forms the sealing ring or the sealing lip when the fluidic
connection 2 has been made. Alternatively, or additionally, it may
be envisaged that the at least one opening region 4A, 4A', 4B, 4B',
preferably the second opening region 4B, 4B', sealingly abuts on a
connecting arrangement 3A, 3A', 3B, 3B', preferably the first or a
corresponding connecting arrangement, particularly the mouth-shaped
portion 5A, 5A', 5B, 5B' thereof, when it has been pierced with the
mouth-shaped portion 5A, 5A', 5B, 5B' in order to produce the
fluidic connection 2.
[0305] At least one opening region 4A, 4A', 4B, 4B', preferably the
at least one opening region 4A, 4A', 4B, 4B', is preferably
constructed to inhibit cracking around the edges and/or to form a
seal and/or it has a material construction or layered structure in
the edge region, which differs by comparison with a central
portion, so that the edge region is more stable and/or acts as a
seal after the edge region has been opened.
[0306] The containers B1, B2, B3 of the proposed container system B
in the initial state have preferably been produced separately from
one another and can be used separately and/or fluidically separated
from one another. The connecting arrangements 3A, 3A', 3B, 3B' are
preferably each fluidically sealed independently of one another in
the initial state. After the fluidic connection 2 has been formed
between the containers B1, B2, B3, these containers are preferably
inseparably or non-releasably connected.
[0307] FIG. 14 shows another container B3, which may also be or
form part of the container system B. The container system B
preferably comprises the container B3. This has two different,
corresponding and/or complementary connecting arrangements 4A, 4A',
4B, 4B'. As a result, this container B3 may serve as an adaptor
between two other containers B1, B2 and/or may be connected to
different containers B1, B2 and/or may allow more than two
substances S1, S2, S3 to be mixed.
[0308] The container B3 comprises both the first connecting
arrangement 3A and the second connecting arrangement 3B on
different, preferably opposite, sides. The container B3 thus
preferably comprises the first connecting arrangement 3A, 3A', on a
first side, and the second of the connecting arrangements 3B, 3B'
on a second side remote from the first side. This container is
preferably free from removal openings E1, E2.
[0309] Moreover, the further container B3 is configured to produce
a fluidic connection 2 on both sides by means of the proposed
connecting system 1. The further container B3 may comprise or
encompass an additional, further substance S3 different from the
previous substances S1, S2, particularly a dry or freeze-dried
substance (lyophilisate).
[0310] A plurality of containers B3 may be joined to one another
and/to the first and/or second container B1, B2. In this way, more
than three substances S1, S2, S3 may be mixed and/or a combination
of more than 3 containers B1, B2, B3 may be formed and/or more than
three containers B1, B2, B3 may be fluidically connected to one
another.
[0311] As already explained in conjunction with FIG. 1, the
proposed connecting system 1 is preferably used for fluidically
connecting bottles or bottle-like containers B1, B2, particularly
for the pharmaceutical sector. It is particularly preferable that
the opening regions 4A, 4B, 4A' 4B' should be adapted to be covered
in sterile manner for transportation.
[0312] FIG. 15 shows a schematic perspective view of a first
connecting arrangement 3A with a severing element 7 arranged on the
opening region 4A. In the embodiment shown in FIG. 15 the severing
element 7 has four or (in dashed lines) three legs, but may also
have more legs 19. The legs 19 are preferably wedge-shaped at least
partially or in areas or have cutting edges remote from the opening
region 4A. The severing element 7 preferably has a point 20 which
is directed away from the opening region 4A. The point 20
preferably adjoins the legs 19 or vice versa. By means of the point
20 and/or the legs 19, shear forces can be increased and the
destruction or perforation of the opening region 3B can be
facilitated. However, other alternative embodiments for the
severing element 7 are theoretically possible.
[0313] In the embodiment shown, the severing element 7 comprises
preferably foot-like connecting portions 21 with the opening region
4B. These may be configured to derive or distribute a force exerted
by the severing element 7, particularly the point 20 or the legs
19, onto the opening region 4A. Alternatively or additionally, the
connecting portions 21 may be provided and arranged so that when
the connecting arrangements 3A, 3B are pushed inside one another
the mouth-shaped portion 5B comes to bear on the connecting
portions 21 or in the vicinity thereof, as a result of which the
shear forces acting on the opening region 4B can be generated or
increased. This assists with the opening of the opening region
4A.
[0314] The severing element 7 is preferably arranged and/or
configured for piercing, severing, cutting or destroying the
opening region 4A, 4A' of the first connecting arrangement 3A,
3A'.
[0315] The severing element 7 is preferably arranged and/or
fastened on the opening region 4B, 4B' of the second connecting
arrangement 3B, 3B', particularly directly. Alternatively, or
additionally, the severing element 7 is configured to concentrate a
force acting on the opening region 4A, 4A' and/or to distribute a
force or counter-force acting on the opening region 4B, 4B' such
that the opening region 3B of the second connecting arrangement 3B,
3B' remains intact when the opening region 4A, 4A' is opened by
destruction thereof by means of the severing element 7.
[0316] In another aspect it is envisaged that the severing element
7 comprises one or more connecting portions 21 to which or with
which the severing element 7 is connected, preferably by material
engagement, with the opening region 4A, 4A', 4B, 4B'.
[0317] The connecting portions 21 preferably form frangible points
for the opening region 4B, 4B' of the second connecting arrangement
3B, 3B'. Preferably, the connecting portions 21 are arranged to
correspond to the first connecting arrangement 3A, 3A',
particularly the mouth-shaped portion 5A, 5A' thereof. Moreover,
the connecting portions 21 are preferably configured so that forces
acting on the opening region 4B, 4B' of the second connecting
arrangement 3B, 3B' are concentrated by the first connecting
arrangement 3A, 3A'. This makes it easier to destroy and/or open
the opening region 4B, 4B' of the second connecting arrangement 3B,
3B' by means of the first connecting arrangement 3A, 3A',
particularly the mouth-shaped portion 5A, 5A' thereof.
[0318] FIG. 16 shows the proposed container system in a
transporting position or orientation. The containers B1, B2, B3 are
preferably releasably connectable to one another for transporting
as a result of a portion or bottle neck F1, F2 of a container B1,
B2, B3 that forms the removal opening being adapted to be held by
the holding device of the cap-like cover device 6.
[0319] The first container B1 is preferably provided with the cover
device 6 or the first connecting arrangement 3A, 3A' is covered by
the cover device 6. The second container B2 is received and/or held
by the cover device 6, preferably in or by means of the region of
its removal opening E2 or its bottle neck F2. In this way or by
some other means, the containers B1, B2 of the container system may
form a kit or a combination which associates the containers B1, B2
with one another. This advantageously makes it possible to avoid
unintended combinations of containers B1, B2 or substances S1,
S2.
[0320] The cover device 6 can preferably be held on the first
container B1 and is configured to hold both the region of the
removal opening E1, E2 or the bottle neck F1, F2 of the first
container B1 and also of the second container B2. In this way the
cover device 6 has a triple function, namely for providing a
(sterile) cover, for forming a transport combination and as a
support foot. The latter will be discussed further hereinafter.
[0321] FIG. 17 shows the first container B1 in longitudinal
section, the first connecting arrangement 3A being covered,
preferably in sterile manner, by the cover device 6. The cover
device 6 may be removably held on the container B1 by means of or
using one of the securing devices 10A, 10B or by some other means
on the first container B1.
[0322] One or both opening regions 4A, 4A', 4B, 4B' are preferably
covered in sterile or sterilizable manner. One of the opening
regions 4A, 4A', 4B, 4B' is preferably separated from the
environment in sterile manner by the cap-like cover device 6. An
(another) opening region 4A, 4A', 4B, 4B' is preferably separated
from the environment in sterile or sterilizable manner by a
removable, detachable, tear-off and/or film-like closure 14.
[0323] A double closure may be formed by the respective opening
region 4A, 4A', 4B, 4B' and the respective sterile or sterilizable
cover. In this way, a sterile or sterilizable or sterile sealed
region or space or cavity can be formed between the sterile or
sterilizable cover and the respective connecting arrangement 3A,
3A', 3B, 3B'.
[0324] The sterile or sterilizable cover is preferably removable.
This makes it possible to produce a (sufficiently) sterile fluidic
connection 2 through the connecting system 1, by removing the
covers and using the opening regions 4A, 4A', 4B, 4B' arranged in
the sterile area to form the fluidic connection 2.
[0325] In the embodiment shown, the cap-like cover device 6 forms a
sterile cover for the first opening regions 4A, 4A' and/or the
closure 14 forms a sterile cover for the second opening region 4B,
4B' by means of a sealed or welded-on or otherwise tightly applied
film. Theoretically, however, the sterile covering may also be
provided by other means, for example by replacing the film with a
cap or a (screw) closure, optionally with a seal or the like,
and/or by constructing the cover device 6 without holding means or
with a different holding device.
[0326] Sterile in the sense of the present invention denotes, in
particular, at least substantially germ-free or aseptic. A sterile
or sterilizable cover is preferably a device designed to prevent
the penetration of germs, particularly by forming a germproof
barrier.
[0327] From the construction point of view, a sterile or
sterilizable cover is preferably tightly applied or connected to
the respective connecting arrangement 3A, 3A', 3B, 3B' so as to
form a germproof barrier.
[0328] A cover is sterilizable particularly when the cover uses
materials, or the sterile or sterilizable cover comprises or is
formed from materials, which are suitable for the use of at least
one method of sterilization known in the prior art for destroying
germs. For example, such materials may be sterilized by one of the
known sterilization methods without being damaged thereby or losing
their function as a barrier against the ingress of germs. The known
sterilization methods include irradiation, particularly with gamma
rays or an electron beam, gassing, treatment with hot air or
autoclaving. Preferably, the connecting arrangements 3A, 3A', 3B,
3B' are also sterile or sterilizable.
[0329] The opening regions 4A, 4A', 4B, 4B' are preferably produced
independently of one another or separately from one another in an
initial state and/or are covered in sterile or sterilizable manner
separately from one another. This enables the containers B1, B2, B3
to be used separately.
[0330] Between the opening region 4A, 4A', 4B, 4B' and the sterile
or sterilizable cover or means for sterile covering, particularly
the cover device 6 and/or the closure 14, a space is preferably
formed which is sterilized, sterilizable and/or sealed in sterile
manner in an initial state or sealed off to be airtight and/or
germproof.
[0331] According to another aspect of the present invention which
can also be implemented independently, a substance, particularly an
active substance, vaccine and/or adjuvant is arranged, attached
and/or immobilized in the space. In particular, the substance is
arranged in a lattice in the space and/or held by the severing
element 7.
[0332] In a preferred aspect the severing element 7 or another part
of one of the connecting arrangements can be dissolved, solubilized
and/or suspended within the space. In this way, after the fluidic
connection 2 has been made, the substance from the space may form
part of the mixture of substances S1, S2, S3.
[0333] The substance arranged in the space may be dissolved and/or
solubilized and/or suspended on the connecting arrangement 3A, 3B,
3A', 3B' or on the opening region 4A, 4A', 4B, 4B' by means of one
of the substances S1, S2, S3.
[0334] In a preferred aspect, a lyophilisate is dried onto or
otherwise applied to the opening region. The lyophilisate as well
as one or more of substances S1, S2, S3 may contain vaccine, active
substance, and/or adjuvant for preparing a vaccine or combined
vaccine. In this way, after the production of the fluidic
connection 2, the substance arranged in the space may form a
component of a substance mixture, particularly a combined
vaccine.
[0335] The means for sterile covering, particularly the cover
device 6 and/or the closure 14, are preferably removable or
detachable, particularly manually or without the use of tools, so
that the opening regions 4A, 4A', 4B, 4B' are accessible for
producing the fluidic connection 2.
[0336] One of the containers B1, B2, B3 preferably comprises, on a
side remote from the removal opening E1, E2, the removable cap-like
cover device 6 which in a starting position closes off the
connecting arrangement 3A, 3A', 3B, 3B', preferably in sterile
manner.
[0337] The cap-like cover device 6 preferably comprises a holding
device for a removal opening E1, E2 or a bottle neck F1, F2. A
holding device, particularly the receptacle 13, is preferably
configured for holding a portion of a container B1, B2, B3,
particularly the bottle neck F1, F2, forming the removal opening
E1, E2, E3.
[0338] The cover device 6 preferably comprises a holding portion
which is shaped like a shoulder and/or to correspond to or
complement a shoulder region of the container B1, B2 adjacent to
the removal opening E1, E2.
[0339] In the embodiment shown the cover device 6 preferably
comprises the receptacle 13 which is configured to receive and/or
retain, preferably by interlocking or latching engagement, the
bottle neck F1, F2 of the container or containers B1, B2.
[0340] The cover device 6 is preferably embodied as a holder or
stand for the container or containers B1, B2. For this purpose, the
removal opening E1, E2 or the bottle neck F1, F2 can preferably be
inserted in the cover device 6. In particular, the receptacle 13 is
configured for clamping and/or latching and/or releasably holding
the container or containers B1, B2, preferably in the region of the
removal opening E1, E2 and/or the bottle neck F1, F2. This
advantageously allows reliable operation as a foot or stand and/or
for holding or forming the kit or combination of containers B1, B2,
particularly bottles, of the container system B.
[0341] The cover device 6 preferably serves as a base or standing
surface for one of the containers B1, B2, particularly the first
container B1, if its opening region 4A is covered by the cover
device 6. It may be provided that the receptacle 13 is arranged at
the bottom in a starting position and/or is accessible from
outside. This has the additional advantage that the containers B1,
B2 can be stacked by placing the first container B1 comprising the
cover device 6 with the receptacle 13 onto the second container B2
in such a way that its removal opening E2 or bottle neck F2 is
pushed into the receptacle 13 and preferably held, particularly by
latching and/or clamping. In this way a kit can be produced in
which the containers B1, B2 are releasably joined together, thus
helping to prevent incorrect packing and erroneous mixing of
substances using the connecting system 1.
[0342] For using the proposed connecting system 1 it may be
envisaged that first of all the cover device 6 is separated or
removed from the first container B1 (cf. FIG. 18).
[0343] As shown in FIG. 19, by way of example, the first container
B1 (or alternatively the second container B2) is then preferably
inserted with the removal opening E1, E2 or the bottle neck F1, F2
or a part thereof in the receptacle 13 of the cover device 6. For
this purpose the cover device 6 may be used with the opening of the
receptacle 13 directed upwards in the position of use, the removal
opening E1, E2 or the bottle neck F1, F2 being pushed into the
receptacle 13 at least partially from above in the position of use.
Theoretically, however, it is also possible to insert the container
B1, B2 into the receptacle 13 in other positions. Preferably, the
cover device 6 is then used as a holder or foot or at the bottom in
the position of use. Thus the first connecting arrangement 3A or
its opening region 4A is accessible from above in the position of
use.
[0344] The cover device 6 can be used as a standing foot for the
container B1, B2, B3 if the container B1, B2, B3 is held by the
holding device or receptacle 13 with the portion forming the
removal opening E1, E2 or the bottle neck F1, F2.
[0345] The cover device 6 thus preferably forms a holder or foot
for the container B1, B2 which is held by the cover device 6. The
dual function of the cover device advantageously saves space and
material and additionally using the cover device 6 as a holder or
foot advantageously prevents contamination of the connecting
arrangements 3A, 3A', 3B, 3B'.
[0346] The cover device 6 is preferably of cap-like formation and
in a starting or transporting position it forms a tight seal with
the connecting arrangement 3A, 3A', 3B, 3B', so as to produce a
sterile or sterilizable closure.
[0347] The cover device 6 preferably comprises the receptacle 13
and a holding portion for holding onto the connecting arrangement
3A, 3A', 3b, 3B' on different sides, particularly opposite sides.
The holding portion may have a region which is releasably fixed or
fixable to the connecting arrangement 3A, 3A', 3b, 3B' by a
clamping and/or latching action. For this purpose the cover device
6 in the holding portion and the connecting arrangement 3A, 3A',
3b, 3B' may be of complementary or corresponding construction.
[0348] The cover device 6 is preferably made of plastics or
contains plastics. The cover device 6 is preferably a thermoformed
part or an injection molded part and/or a shaped part produced from
a sheet material. The cover device 6 preferably has a wall
thickness of more than 1 mm and/or less than 2 mm. However, other
solutions are also possible here.
[0349] In the embodiment shown, the cover device 6 is essentially
in the shape of a W or U in longitudinal section, with an
indentation in the curve of the U which forms the receptacle 13. In
principle, however, the cover device 6 may also be formed
differently for the dual function of a sterile closure on the one
hand and a holding device on the other.
[0350] FIG. 20 shows the second container B2 in which the opening
region 4B is closed off, particularly in sterile manner, by the
closure 14, particularly a removable cover, film, sealing film or
the like. Preferably the closure 14 is removable, particularly by
pulling off, in order to use the proposed connecting system 1. The
closure 14 may have a tab for this purpose.
[0351] At least one of the connecting arrangements 3A, 3A', 3B,
3B', specifically the second connecting arrangement 3B, 3B' in the
embodiment shown, preferably has a receptacle for another one of
the connecting arrangements 3A, 3A', 3B, 3B' which may preferably
be formed by a collar-like portion 22 or alternatively or
additionally by some other means. The collar-like portion 22 may
assist with fitting the connecting arrangements 3A, 3A', 3B, 3B'
into one another, guide the required movement and/or protect the
connecting arrangements 3A, 3A', 3B, 3B' at the sides. It
preferably comprises the securing devices 10A, 10B or parts
thereof.
[0352] Preferably, one of the connecting arrangements 3A, 3A', 3B,
3B', particularly the second connecting arrangement 3B, 3B', is
surrounded by the collar-like portion 22 in the (first and/or
second) connecting position.
[0353] The collar-like portion 22 preferably serves to receive the
(respectively) other connecting arrangement 3A, 3A', 3B, 3B' or to
form a receptacle and/or guide, preferably a linear guide for this
purpose, particularly in the direction of the central axis or axis
of symmetry 9.
[0354] In the embodiment shown the collar-like portion 22 is
provided on or around the second connecting arrangement 4B, 4B' or
on the second container B2. Alternatively or additionally, however,
the collar-like portion 23 may also be provided around the first
connecting arrangement 4A, 4A' or on the first container B2.
[0355] The collar-like portion 22 is preferably fixedly, rigidly
and/or non-rotationally connected to a or the associated connecting
arrangement 3A, 3A', 3B, 3B', preferably by interlocking
engagement, particularly by latching, and/or by frictional
engagement, particularly by clamping, and/or by material
connection, particularly by adhesive bonding or injection molding,
but alternatively also by being formed in one piece with one of the
connecting arrangements 3A, 3A', 3B, 3B' or containers B1, B2.
[0356] The collar-like portion 22 preferably projects beyond the
mouth-shaped portion 5A, 5B, 5A', 5B' and/or extends at least
partially parallel thereto or in the same direction and preferably
thereby forms the receptacle or linear guide for the other one of
the connecting arrangements 3A, 3A', 3B, 3B'.
[0357] The collar-like portion 22 or the receptacle that may be
formed by it preferably at least partially comprises the guide 18A,
18B, particularly the slide, a guide pin or the like.
[0358] An open edge of the collar-like portion 22 preferably forms
a stop for those of the connecting arrangements 3A, 3A', 3B, 3B'
which it does not surround in the separated state of the connecting
arrangements 3A, 3A', 3B, 3B' and/or for the container B1 connected
thereto. Preferably in the second connecting position the
connecting arrangements 3A, 3A', 3B, 3B' abut on one another in the
region of the stop.
[0359] The collar-like portion 22 is preferably closed off,
particularly in sterile manner, at one end or on an open side by
the closure 14, particularly a film applied as a seal.
[0360] FIG. 21 shows by way of example how the containers B1, B2
can be fluidically connected to one another by the proposed
connecting system 1. For this purpose the closure 14 is preferably
removed from the second container B2 and the second container B2 is
then placed with the second connecting arrangement 3B, 3B' onto the
first connecting arrangement 3A, 3A' from above. In the embodiment
shown the first connecting arrangement 3A, 3A' extends into the
receptacle formed by the collar-like portion 22.
[0361] Then the opening regions 4A, 4A', 4B, 4B' are opened. By
combining the connecting arrangements 3A, 3B, which form, in
particular, base regions of the bottles or bottle-like containers
B1, B2, the fluidic connection 2 can be produced, as already
explained in relation to FIGS. 2 to 8. FIG. 21 shows the first
embodiment but the same also applies to the second embodiment and
the combination of embodiments.
[0362] According to another aspect of the present invention which
can also be implemented independently, the connecting system 1 or
the connecting arrangements 3A, 3B, 3A', 3B' are specific to a
particular size of container.
[0363] In particular, a proposed container system B comprises
containers B1, B2, B3 of different sizes, volumes and/or with
specific quantities of substance S1, S2, S3 for producing a desired
mixing ratio. For this it is preferable for the connecting
arrangements 3A, 3B, 3A', 3B' to be selectively configured
(mechanically) such that containers B1, B2, B3 with compatible
contents can be connected and containers B1, B2, B3 with
incompatible contents, or containers B1, B2, B3 which would lead to
an undesirable or unsuitable mixing ratio if a fluidic connection 2
were produced, have connecting arrangements 3A, 3B, 3A', 3B' which
are mechanically incompatible with one another.
[0364] Particularly preferably, the connecting arrangements 3A, 3B,
3A', 3B' may be constructed selectively with respect to one
another, particularly according to the lock and key principle. This
can be achieved using guides 18A, 18B, guiding slides, diameters or
the like which are compatible or incompatible with one another,
respectively.
[0365] The aspects of the present invention described in connection
with FIGS. 16 to 21 may be advantageous on their own and in various
combinations, preferably wholly or partially or in certain details
in the sequence of the explanations. In particular, the cover
device 6 is preferably removed and used as a holder or foot before
the second connecting arrangement 3B is opened or unsealed,
particularly by removal of the closure 14.
[0366] Moreover, FIGS. 16 to 21 show the connecting arrangements
3A, 3B of the first embodiment. Instead of these, however, it is
also possible to use the connecting arrangements 3A', 3B' of the
second embodiment or a combination of the first connecting
arrangements 3A, 3A' and the second connecting arrangements 3B,
3B'. The aspects explained then apply accordingly.
[0367] The fluidic connection 2 may thus alternatively or
additionally be produced by deformation. In this case the severing
element 7 is optional and the collar-like portions 22 are
preferably non-round in cross section, so that when the connecting
arrangements 3A, 3B, 3A', 3B' are rotated relative to one another
the fluidic connection 2 is produced by shaping or deformation. In
the interests of clarity, the corresponding procedure will not be
repeated here.
[0368] Further aspects of the present invention which may be
implemented separately and combined with one another and/or may be
implemented with aspects and features of the present invention as
explained hereinbefore and which are advantageous will be described
in more detail hereinafter.
[0369] An aspect of the present invention which can be implemented
independently, or in conjunction with one or more of the preceding
aspects, relates to a connecting system 1 for producing a fluidic
connection 2, preferably between containers B1, B2, B3, wherein the
connecting system 1 comprises at least two connecting arrangements
3A, 3A', 3B, 3B' configured to form the fluidic connection 2,
namely a first connecting arrangement 3A, 3A' and a second
connecting arrangement 3B, 3B', which, in an initial state, are
each fluidically sealed and are sealed independently of one
another, the connecting arrangements 3A, 3A', 3B, 3B' being capable
of insertion in one another and/or being adapted to be inserted in
one another by a preferably at least substantially linear and/or
axial movement along a common axis, by means of which at least one
of the connecting arrangements 3A, 3A', 3B, 3B' can be opened.
[0370] In particular, the fluidic connection 2 is formed by an
insertion process. This is advantageously carried out, for example,
by producing the fluidic connection 2 particularly quickly and
reliably, in particular without the need for repeated rotation of
the connecting arrangements 3A, 3A', 3B, 3B' by means of a helical
line with a number of turns or by means of a thread.
[0371] The insertion of the connecting arrangements 3A, 3A', 3B,
3B' into one another also allows the connecting arrangements 3A,
3A', 3B, 3B' to be brought together in a manner oriented with one
another in relation to the position of rotation about the (common)
axis of symmetry or central axis 9, which is particularly
advantageous if the mouth portions 5A, 5A', 5B, 5B' of the
connecting arrangements 3A, 3A', 3B, 3B' are non-round in cross
section or the opening of at least one of the connecting
arrangements 3A, 3A', 3B, 3B' is produced by deformation and the
resultant tensioning of an opening region 4A, 4A', 4B, 4B'.
[0372] An aspect of the present invention which can also be
implemented independently or in conjunction with one or more of the
preceding aspects relates to a connecting system 1 for producing a
fluidic connection 2, preferably between containers B1, B2, B3,
wherein the connecting system 1 comprises at least two connecting
arrangements 3A, 3A', 3B, 3B' configured to produce the fluidic
connection 2, namely a first connecting arrangement 3A, 3A' and a
second connecting arrangement 3B, 3B', which are fluidically sealed
off in a starting state, the first connecting arrangement 3A, 3A'
having an in particular film-like, brittle and/or unstable opening
region 4A, 4A', 4B, 4B', being deformable outside the opening
region 4A, 4A', 4B, 4B' and being configured so that the
deformation causes opening of the first connecting arrangement 3A,
3A', 3B, 3B' in the opening regions 4A, 4A', 4B, 4B'.
[0373] An aspect of the present invention which can also be
implemented independently, or in conjunction with one or more of
the preceding aspects, relates to one or more containers B1, B2, B3
or vessels which comprise connecting arrangements 3A, 3A', 3B, 3B'
in each case.
[0374] An aspect of the present invention which can also be
implemented independently or in conjunction with one or more of the
preceding aspects relates to a connecting system 1 for producing a
fluidic connection 2, preferably between containers B1, B2, B3, the
connecting system 1 having at least two connecting arrangements 3A,
3A', 3B, 3B' configured to produce the fluidic connection 2, the
connecting arrangements 3A, 3A', 3B, 3B' each comprising an opening
region 4A, 4A', 4B, 4B' which is fluidically closed in a starting
state, particularly in the manner of a film, or is brittle, fragile
and/or unstable, the opening regions 4A, 4A', 4B, 4B' each being
covered in sterile or sterilizable manner.
[0375] In particular, the opening or formation of the fluidic
connection 2 is thus achieved by the fact that the opening region
4A, 4A' of the first connecting arrangement 3A, 3A' is or forms a
frangible point, so that deformation of the first connecting
arrangement 3A, 3A', particularly by tensioning, leads to tearing
or breaking of the opening region 4A, 4A'. This has the particular
advantage that no point or other severing element is required for
this opening process. Severing elements 7 usually have to be
sharp-edged and stabilized to allow the opening up of an opening
region 4A, 4A', 4B, 4B'. Consequently, by avoiding such a severing
element, the manufacturing process can use gentler materials and/or
be simpler. As already explained hereinbefore, however, a
combination of the above aspects using a severing element 7 is also
possible, while the present aspect is advantageous for enlarging or
expanding an opening or the fluidic connection 2.
[0376] The sterile or sterilizable covers of the opening regions
4A, 4A', 4B, 4B' advantageously make it possible to produce the
fluidic connection 2 while excluding germs or other foreign
substances, particularly in the pharmaceutical/medical sector.
Alternatively, or additionally, the sterile or sterilizable
covering of the opening regions 4A, 4A', 4B, 4B' offers the
possibility of using containers B1, B2, B3 with the connecting
arrangement 3A, 3A', 3B, 3B' separately from one another in this
environment and optionally in combination with one another.
[0377] One aspect of the present invention which can also be
implemented independently or in conjunction with one or more of the
preceding aspects relates to a container system B with at least two
containers B1, B2, B3, preferably bottles, and the connecting
system 1, wherein the containers B1, B2, B3 for providing a fluidic
connection 2 between the containers B1, B2, B3 in each case
comprise at least one connecting arrangement 3A, 3A', 3B, 3B' of
the connecting system 1.
[0378] In this connection, the use of the proposed connecting
system 1 for connecting containers B1, B2, B3 has proved
advantageous particularly because it is possible to produce a
non-releasable and/or irreversible fluidic connection 2 between the
containers B1, B2, B3, thus ensuring complete mixing of the
contents of the containers B1, B2, B3.
[0379] Another aspect of the present invention which can also be
implemented independently or in conjunction with one or more of the
preceding aspects relates to a container system B with at least two
containers B1, B2, B3, preferably bottles, each of which comprises
a removal opening E1, E2, preferably each closed off by a septum,
while preferably the containers B1, B2, B3 comprise, on a side
remote from the respective removal opening E1, E2, particularly on
the base of the respective bottle, a connecting arrangement 3A,
3A', 3B, 3B' for providing a fluidic connection 2 between the
containers B1, B2, B3 and/or are configured for providing a fluidic
connection 2 between the containers B1, B2, B3.
[0380] The use of two containers B1, B2, B3, each of which
comprises a removal opening E1, E2 and a connecting arrangement 3A,
3A', 3B, 3B', is particularly advantageous because the containers
B1, B2, B3 can also be used separately from one another, but at the
same time, in the event of joint use by means of the connecting
arrangements 3A, 3A', 3B, 3B', a fluidic connection with a
relatively large cross-section is made possible for the rapid or
accelerated mixing of the contents of the containers B1, B2,
B3.
[0381] Another aspect of the present invention which can also be
implemented independently or in conjunction with one or more of the
preceding aspects relates to a method for providing a fluidic
connection 2 between connecting arrangements 3A, 3A', 3B, 3B'
and/or containers B1, B2, B3 by means of the connecting
arrangements 3A, 3A', 3B, 3B', wherein in an initial state the
connecting arrangements 3A, 3A', 3B, 3B' are in each case
fluidically sealed, wherein a first connecting arrangement 3A, 3A'
is opened by another, second connecting arrangement 3B, 3B' and the
second connecting arrangement 3B, 3B' is opened by the by the first
connecting arrangement 3A, 3A', thus producing a continuous fluidic
connection 2 between the connecting arrangements 3A, 3A', 3B,
3B'.
[0382] This results in corresponding advantages, i.e., in
particular, a rapid and reliable formation of the fluidic
connection 2 or mixing of the substances S1, S2, S3.
[0383] Another aspect of the present invention which can also be
implemented independently or in conjunction with one or more of the
preceding aspects relates to a use of a container system B, wherein
a first container B1 holds a first substance S1, particularly a
first vaccine against a first disease, while a second container B2
holds a second substance S2, particularly a second vaccine against
a second disease different from the first, for the preparation of a
mixture of substances, particularly for the preparation of a
combined vaccine for simultaneous immunization against different
diseases, wherein the containers B1, B2, B3 are fluidically
connected to one another by means of the connecting arrangements
3A, 3A', 3B, 3B', so that the substances are mixed together,
particularly to form the combined vaccine.
[0384] The use of the proposed connecting system 1 or container
system B for the preparation of combined vaccine is advantageous
for example because the vaccines may be used individually or in
combination, as desired. The proposed connecting system 1 or
container system B offers the flexibility of deciding on the spot
whether the substances S1, S2, S3 or vaccines are to be
administered individually or in combination. This advantageously
avoids subjecting animals to stress by an unnecessarily large
number of separate injections or unnecessarily always having to
vaccinate them with a combined vaccine, even when there is no need
for one of the vaccines to be given, because of an existing
immunity. In this way, the present invention can save materials and
costs.
[0385] Another aspect of the present invention which can also be
implemented independently or in conjunction with one or more of the
preceding aspects relates to a method for providing a fluidic
connection 2 between connecting arrangements 3A, 3A', 3B, 3B'
and/or containers B1, B2, B3 by means of connecting arrangements
3A, 3A', 3B, 3B' of the connecting system 1, wherein preferably the
means for sterile covering, particularly the cover device and/or
the closure 14, is removed from the opening regions 4A, 4A', 4B,
4B' in each case and the still closed opening regions 4A, 4A', 4B,
4B' thus exposed are opened up to form the fluidic connection
2.
[0386] Another aspect of the present invention which can also be
implemented independently or in conjunction with one or more of the
preceding aspects relates to a method for providing a fluidic
connection 2 between connecting arrangements 3A, 3A', 3B, 3B'
and/or containers B1, B2, B3 by means of the connecting
arrangements 3A, 3A', 3B, 3B', wherein in an initial state the
connecting arrangements 3A, 3A', 3B, 3B' are in each case
fluidically sealed, while a first connecting arrangement 3A, 3A' is
opened by another second connecting arrangement 3B, 3B' and the
second connecting arrangement 3B, 3B' is opened by the first
connecting arrangement 3A, 3A', thus producing a continuous fluidic
connection 2 between the connecting arrangements 3A, 3A', 3B,
3B'.
[0387] In another aspect which may thus be implemented
independently, the present invention relates to a kit with two
proposed containers B1, B2, B3 or with containers B1, B2, B3, which
can be fluidically connected to one another by means of the
connecting system 1, so that a mixture of the substances S1, S2, S3
contained in the containers B1, B2, B3 can be formed. This prevents
other, incompatible substances S1, S2, S3 from being mixed.
[0388] A kit in the sense of the present invention is particularly
a combination and/or system comprising the first container B1 and
the second container B2, which form the components of the kit. The
kit may also comprise the third container B3 and/or further
containers or components.
[0389] The components of the kit are preferably marketed as a set,
particularly in a joint pack or the like. However, it is also
possible for the components to form a loose combination to be used
together. A common or connecting component may be provided, for
example a common set of instructions for use, handling
recommendations, information in the text on one or more of the
components of the kit or the like.
[0390] Preferably, the containers B1, B2, B3 form a kit by being
held together, particularly preferably by means of the cover device
6 or the receptacle 13.
[0391] The containers B1, B2, B3 are preferably designed for the
preparation of a combined vaccine for simultaneous immunization
against different diseases, preferably by making the containers B1,
B2, B3 capable of fluidic connection to one another by means of the
connecting arrangements 3A, 3A', 3B, 3B', so that substances S1,
S2, S3 located in the containers B1, B2, B3 are mixed together to
form the combined vaccine, while in particular the substances S1,
S2, S3 can be removed through the removal opening E1, E2 separately
from one another and then used, particularly before or without
forming the fluidic connection 2.
[0392] Preferably, at least one of the containers B1, B2, B3
comprises a removal opening E1, E2, preferably closed off with a
septum, while the container B1, B2, B3 is preferably configured, on
a side remote from the removal opening E1, E2, particularly on the
bottom of the bottle, for providing a fluidic connection 2 between
the containers B1, B2, B3 and/or comprises the connecting
arrangement 3A, 3A', 3B, 3B'.
[0393] The containers B1, B2, B3 are preferably fluidically
connected to one another by means of the connecting arrangements
3A, 3A', 3B, 3B', so that the substances are mixed together,
preferably forming a combined vaccine.
[0394] In another aspect which may thus be implemented
independently, the present invention relates to the use of a
connecting system 1, kit or container system B as proposed, for the
preparation or provision of medicaments for live animals,
preferably mammals, and/or for medical uses.
[0395] In another aspect which may thus be implemented
independently, the present invention relates to the use of a
connecting system 1, kit or container system B as proposed, for the
preparation and/or provision of a vaccine, particularly for
immunizing against the disease(s) Porcine Circovirus Disease "PCVD"
and/or Enzootic Pneumonia "EP" or infections with Porcine
Circovirus and/or infection with bacteria of the Mycoplasma strain,
particularly Mycoplasma hyopneumoniae, preferably for immunizing
against the diseases Porcine Circovirus Disease "PCVD" and Enzootic
Pneumonia "EP" or against infections with Porcine Circovirus and/or
infection with bacteria of the Mycoplasma strain, particularly
Mycoplasma hyopneumoniae.
[0396] For this purpose, a first proposed container B1 contains as
the first substance S1 a first reactant and a second proposed
container B2 contains as the second substance S2 a second reactant.
The reactants may be vaccines against different diseases or the
educts may contain vaccines against different diseases.
[0397] It is particularly preferable for the first reactant to
contain only a first one of the components Mycoplasma vaccine or
Mycoplasma antigen and Circovirus vaccine or Circovirus antigen
(and optionally other substances). The first reactant may thus
contain either Mycoplasma vaccine, or one or more Mycoplasma
antigens or alternatively Circovirus vaccine or one or more
Circovirus antigens. The first reactant is preferably stored
separately from the second reactant, particularly if the reactants
are not stable in the long term together. The second reactant
preferably contains only the other one of the components Mycoplasma
vaccine or one or more Mycoplasma antigens and Circovirus vaccine
or one or more Circovirus antigens (and optionally other
substances). If the first reactant thus contains Mycoplasma vaccine
or one or more Mycoplasma antigens, the second reactant contains
Circovirus vaccine or one or more Circovirus antigens, or vice
versa.
[0398] The Mycoplasma vaccine may contain attenuated and/or
inactivated bacteria, fragments of bacteria or recombinantly
prepared parts of Mycoplasma hyopneumoniae, but at least one or
more Mycoplasma hyopneumoniae antigens. Preferably, the Mycoplasma
hyopneumoniae antigen originates from the Mycoplasma hyopneumoniae
J-strain or the inactivated Mycoplasma hyopneumoniae bacteria are
those of the J-strain. Moreover, the Mycoplasma vaccine may be one
of the following vaccines or the Mycoplasma hyopneumoniae antigen
may be the antigen or antigens contains in one of the following
vaccines: Ingelvac.RTM. MycoFlex (Boehringer Ingelheim Vetmedica
Inc, St Joseph, Mo., USA), Porcilis M. hyo, Myco Silencer.RTM. BPM,
Myco Silencer.RTM. BPME, Myco Silencer.RTM. ME, Myco Silencer.RTM.
M, Myco Silencer.RTM. Once, Myco Silencer.RTM. MEH (all from
Intervet Inc., Millsboro, USA) Stellamune Mycoplasma (Pfizer Inc.,
New York, N.Y., USA), Suvaxyn Mycoplasma, Suvaxyn M. hyo, Suvaxyn
MH-One (all formerly Fort Dodge Animal Health, Overland Park,
Kans., USA (now Pfizer Animal Health).
[0399] The Circovirus vaccine may contain attenuated and/or
inactivated porcine Circovirus, preferably type 2, particularly
type 2 ORF2 protein. It is particularly preferable to use
recombinantly expressed ORF2 protein of the Porcine Circovirus type
2, preferably expressed in and obtained from in vitro cell culture.
Examples of ORF2 proteins of the Porcine Circovirus type 2 are
described inter alia in International Patent Application
WO2006-072065. These have proved particularly advantageous for
effective vaccination. Moreover, the Circovirus vaccine may be one
of the following vaccines, or the Circovirus antigen may be the
antigen or antigens contained in one of the following vaccines:
Ingelvac.RTM. CircoFLEX, (Boehringer Ingelheim Vetmedica Inc, St
Joseph, Mo., USA), CircoVac.RTM. (Merial SAS, Lyon, France),
CircoVent (Intervet Inc., Millsboro, Del., USA), or Suvaxyn PCV-2
One Dose.RTM. (Fort Dodge Animal Health, Kansas City, Kans.,
USA).
[0400] The Circovirus vaccine, if it contains the ORF2 protein,
preferably contains between 2 .mu.g and 150 .mu.g, preferably
between 2 .mu.g and 60 .mu.g, more preferably between 2 .mu.g and
50 .mu.g, more preferably between 2 .mu.g and 40 .mu.g, more
preferably between 2 .mu.g and 30 .mu.g, more preferably between 2
.mu.g and 25 .mu.g, more preferably between 2 .mu.g and 20 .mu.g,
more preferably between 4 .mu.g and 20 .mu.g, more preferably
between 4 .mu.g and 16 .mu.g of ORF2 protein per dose to be
administered. The Circovirus vaccine is preferably prepared or
formulated so that 1 ml of the vaccine corresponds to a dose of 1.
In particular, the Circovirus vaccine may contain ORF2 protein in
amounts of more than 2 .mu.g/ml, preferably more than 4 .mu.g/ml
and/or less than 150 .mu.g/ml, preferably less than 60 .mu.g/ml, 50
.mu.g/ml, 40 .mu.g/ml, 30 .mu.g/ml or 25 .mu.g/ml, particularly
less than 20 .mu.g/ml. This contributes to reliability of
administration.
[0401] The Mycoplasma vaccine, if it contains inactivated
Mycoplasma bacteria, preferably inactivated Mycoplasma
hyopneumoniae bacteria, preferably contains between 10.sup.3 and
10.sup.9 colony forming units (CFU), preferably between 10.sup.4
and 10.sup.8 (CFU), more preferably between 10.sup.5 and 10.sup.6
(CFU) per dose to be administered, the corresponding CFU being
adjusted before the inactivation of the bacteria. The Mycoplasma
vaccine is preferably prepared or formulated so that 1 ml of the
vaccine corresponds to a dose of 1. In particular, the Mycoplasma
vaccine may contain more than 10.sup.3 CFU/ml, preferably more than
10.sup.4 CFU/ml, particularly more than 10.sup.5 CFU/ml and/or less
than 10.sup.9 CFU/ml, preferably less than 10.sup.8 CFU/ml,
particularly less than 10.sup.7 CFU/ml or 10.sup.6 CFU/ml of
inactivated Mycoplasma bacteria, preferably inactivated Mycoplasma
hyponeumoniae bacteria, particularly before the inactivation of the
bacteria.
[0402] At least one of the reactants and/or the vaccine or combined
vaccine may contain an adjuvant, preferably a polymeric adjuvant,
particularly carbomer. Preferably at least or precisely one of the
two reactants, preferably both reactants, contain a quantity of
adjuvant of 500 .mu.g to 5 mg, preferably from 750 .mu.g to 2.5 mg,
more preferably about 1 mg of adjuvant per dose to be administered.
The reactants are preferably prepared or formulated so that 1 ml of
the respective reactant corresponds to a dose of 1. The use of an
adjuvant, preferably a polymeric adjuvant, such as carbomer, for
example, has proved advantageous in relation to the efficiency of
immunization or the duration of the effect. However, the use of
alternative and/or additional adjuvants is not ruled out.
[0403] According to another aspect of the present invention, the
first and/or the second and/or the combination of the first and
second container B1, B2, B3 with the fluidic connection 2 provided
may be configured for use in or with an injection device, and/or
used therein. In particular, it is an injection device which can be
reused repeatedly, for example an injection gun, a pressure
injector and/or a self-filling syringe, of the kind used for
vaccinating large herds of animals, for example.
[0404] The kit or container system B according to the invention may
comprise such an injection device or may be associated with one. In
particular, the removal opening E1, E2 or another opening, a flange
or other connecting or closing element of at least one of the
containers B1, B2 and/or of both containers B1, B2 may be
configured so as to allow direct use in or with the injection
device. Moreover, the removal device, the opening, the flange or
other connecting or closing element may be configured specifically
for connection to a particular injection device. This can reduce
the probability of incorrect use, particularly the wrong amounts of
active substance or methods of administration.
[0405] An aspect of the present invention which may also be
implemented independently further relates to an injection device
with an inserted combination of at least two of the proposed
containers B1, B2, B3, which are fluidically connected to one
another with the connecting arrangements 3A, 3A', 3B, 3B' according
to the present invention. In particular, by means of the fluidic
connection 2, a mixture of the substances S1, S2, S3 from the
containers B1, B2, B3 is formed and the injection device is set up
for injecting the mixture of substances S1, S2, S3.
[0406] Further aspects of the present invention will be explained
hereinafter with reference to another embodiment, detailing only
the differences and special features compared with the embodiments
described hereinbefore. The aspects can therefore be combined with
the aspects described previously, and vice versa, unless this is
specifically ruled out. Moreover, reference will be made to the
previous explanations and definitions.
[0407] The embodiment described hereinafter with reference to FIG.
22 ff. preferably relates to the variant described above in which
the first connecting arrangement 3A' is deformable outside the
opening region 4A' and is configured so that the deformation causes
the first connecting arrangement 3A' to open in the opening region
4A'. For further details, reference may be made to FIGS. 5 to 13
and the related explanations.
[0408] According to an aspect of the present invention which can
also be implemented independently, the first connecting arrangement
3A' comprises a preferably rigid, stiff and/or dimensionally stable
closure device 23, particularly a closure plate. The closure device
23 is preferably sealingly attached to a holding portion 25 by
means of a fragile frangible point 24, particularly a thin point.
The opening region 4A' of the first connecting arrangement 3A' may
thus be formed with or by the closure device 23 and/or frangible
point 24.
[0409] The aspects explained previously in connection with the
fragility of the opening region 4A', particularly with regard to
the material thickness and the like, can preferably be applied to
or transferred to the frangible point 24. The difference thus lies
particularly in the fact that the opening region 4A' of the first
connecting arrangement 3A' additionally comprises the closure
device 23 which stabilizes or reinforces the opening region 4A' in
a central portion or a portion surrounded by a film-like, brittle,
unstable and/or fragile region in the form of the frangible point
24.
[0410] The holding portion 25 preferably corresponds to the
mouth-shaped portion 5A' of the first connecting arrangement 3A'
and/or the mouth-shaped portion 5A' comprises the holding portion
25. The related explanations in connection with the mouth-shaped
portion 5A' may therefore be applied to the holding portion 25 as
well, in an alternative or supplementary capacity. If necessary,
the holding portion 25 can therefore also be designated a
mouth-shaped portion 5A' or be wholly or partially formed thereby
or vice versa.
[0411] Particularly preferably, the holding portion 25 is movable
by deformation relative to the closure device 23, so that the first
connecting arrangement 3A' can be opened by tearing the frangible
point 24. It has advantageously been found that the use of a
closure device 23 and the concomitant concentration of the force
applied by the deformation on a fragile area (frangible point 24)
surrounding the closure device 23 makes it possible to achieve a
particularly reliable and simpler opening by means of
deformation.
[0412] FIG. 22 shows an overview of the container system B, in
which the containers B1, B2 are fluidically connected to one
another by means of the connecting arrangements 3A', 3B'. For this
purpose, the first connecting arrangement 3A' or its opening region
4A' and the second connecting arrangement 3B' or its opening region
4B' are shown open in each case.
[0413] For the following explanations, reference is additionally
made to FIGS. 23 to 26, while FIG. 23 shows a longitudinal section
through the first container B1 with the first connecting
arrangement 3A' in an initial state with the opening region 4A'
closed. FIG. 24 shows a magnified detail of a partial region of the
closure device 23 and of the holding portion 25 with the frangible
point 24 between them. In the embodiment shown according to FIG. 23
the opening region 4A' is covered by a preferably cap-like cover
device 26. The cover device 26 has been removed in the embodiment
shown in FIG. 25. FIG. 26 shows a perspective representation of the
first connecting arrangement 3A' as part of the first container B1
without the cover device 26.
[0414] The closure device 23 is preferably configured and/or held
by means of the frangible point 24 such that the closure device 23
is inclined as the holding portion 25 is deformed.
[0415] Preferably, the frangible point 24 or a surface or plane 27
formed or defined by the frangible point 24 is inclined relative to
the central axes or axes of symmetry 9. This enables or facilitates
pushing, rotation and/or further inclination of the closure device
23 during the opening process or prevents blockade of the closure
device 23 relative to the holding portion 25.
[0416] During the opening process the closure device 23 may slide
over the holding portion 25 as a result of the deformation of the
holding portion 25, particularly while being inclined or
tilting.
[0417] The holding portion 25 preferably comprises a frame 28 or is
of a frame-like construction. The closure device 23 is preferably
inclined relative to the frame 28 in the initial state. As a
result, the frame 28 and the closure device 23 are each partially
offset from one another, with the result that an offset directly
adjacent the frangible point 24 may form this or an offset region.
The offset is preferably aligned in opposite directions on opposite
sides. The advantage of the offset is that during deformation of
the holding portion 25 the closure device 23 is able to slide along
the frame 28 or tuck in behind it. This makes the opening process
easier because blocking of the deformation of the holding portion
25 by the closure device 23 is prevented and as a result the
opening of the opening region 4A' is made easier.
[0418] Preferably, particularly as a result of the step-like offset
of the frame 28 relative to the edge of the closure device 23
adjacent the frangible point 24 and/or as a result of the
inclination of the closure device 23 and/or the frangible point 24
relative to the central axis 9, a shearing action of the closure
device 23 relative to the frame 28 is made possible, or is achieved
during deformation. Such a shearing action advantageously makes it
possible to apply a strong mechanical stress to the frangible point
24, in relation to the degree of deformation of the holding portion
25, particularly by producing tensile and/or shear stresses, thus
making the severing or tearing of the frangible point 24 easier.
Overall, this provides a comfortable and reliable method of opening
the opening region 4A' of the first connecting arrangement 3A'.
[0419] According to a further aspect of the present invention the
closure device 23 is formed in a ramp shape starting from the
frangible point 24 provided on the edge thereof. This may be
achieved by increasing the material thickness, preferably in
relation to a surface or plane 27 defined by or extending through
the frangible point 24. Alternatively, or additionally the closure
device 23 is formed in a ramp shape starting from the offset
region. In this way it is possible to incline the closure device 23
increasingly as the deformation of the holding portion 25
progresses. The ramp-like portion of the closure device 23 can
slide along the holding portion 25 and thereby produce an
increasing inclination.
[0420] The closure device 23 itself preferably comprises a
reinforcement 29, in the embodiment shown in the form of ribs or
some other added material or added thickness of material that will
improve mechanical stability. This reinforcement 29 may be formed
at the edge of the closure device 23 or may be configured like a
ramp, starting from the frangible point 24 provided at the edge,
particularly such that the closure device 23 is increasingly
inclined as deformation progresses.
[0421] As may be seen for example in the perspective view in FIG.
26, the holding portion 25 is preferably non-round perpendicularly
to the central axis or axis of symmetry 9, particularly oval in
shape, as explained previously in connection with FIGS. 5 to 13.
The same also applies alternatively or additionally to the
frangible point 24 and/or an encircling edge of the closure device
23 or such an edge adjoining the frangible point 24 and/or to the
frame 28.
[0422] The frangible point 24, particularly the thin point, is
preferably so fragile that deformation of the holding portion 25
can cause tearing of the frangible point 24 and hence opening of
the connecting arrangement 3A'.
[0423] In the embodiment shown the frangible point 24 is only ten
microns thick, preferably less than 300 microns, more preferably
less than 200 microns or less than 150 microns. The distance
between the holding portion 25 and the closure device 23, which is
tightly bridged by means of the frangible point 24, is preferably
less than 3 mm, particularly preferably less than 2 or 1 mm, in the
embodiment shown less than 0.5 mm. It is also preferable if the
distance between the closure device 23 and holding portion 25 or
the length of the frangible point 24 does not exceed, or only
slightly exceeds, corresponding values in the entire area
surrounding the closure device 23. The frangible point 24 thus
preferably has an at least substantially constant length and/or
material thickness in its extent around the closure device 23. The
frangible point 24 thus preferably surrounds the closure device 23
at least substantially completely.
[0424] The holding portion 25 is preferably deformable by insertion
in a deforming device 30 of at least substantially complementary
shape and subsequent rotation of the holding portion 25 relative to
the deforming device 30 about the central axis and/or axis of
symmetry 9. In particular, the holding portion 25 is radially
deformable in relation to and/or in the direction of the central
axis and/or axis of symmetry 9.
[0425] FIG. 27 shows a section through a second container B2 with
the second connecting arrangement 3B' and FIG. 28 shows a magnified
detail thereof. FIG. 29 shows the second container B2 with the
cover device 6 removed and FIG. 30 shows a perspective view of the
second connecting arrangement 3B'.
[0426] The deforming device 30 is particularly preferably formed by
the second connecting arrangement 3B', particularly its
mouth-shaped portion 5B'. For this, reference is made to the
corresponding explanation in connection with FIGS. 5 to 13 and to
the following explanations of the second connecting arrangement 3B'
from the embodiment shown in FIG. 22.
[0427] The holding portion 25 of the first connecting arrangement
3A' is preferably in the shape of a neck, collar and/or tube with,
and in particular by means of, a flexible deformable wall 31. In
the embodiment shown in FIG. 22 ff. the wall 31 forms a preferably
at least substantially conical shape converging towards the frame
28, which may form the mouth-shaped portion 5A' in the present
case. However, other solutions are also theoretically possible
here.
[0428] It is also preferable that the holding portion 25,
particularly the frame 28, has a piercing and/or cutting edge 32 or
other severing element 7. The piercing and/or cutting edge 32 is
preferably attached to the frame 28, formed by the frame 28,
particularly in one piece and/or by molding on. The piercing and/or
cutting edge 32 is preferably formed by an at least substantially
axially extending strip preferably forming a point.
[0429] The piercing and/or cutting edge 32 is preferably configured
to open the second connecting arrangement 3B', particularly as a
result of the opening region 4B' of the second connecting
arrangement 3B' being perforated or pierced by means of the
piercing and/or cutting edge 32. Preferably, during an axial
movement of the connecting arrangements 3A', 3B' to one another,
the opening region 4B of the second connecting arrangement 3B' is
first of all pierced by the piercing and/or cutting edge 32
projecting axially outwards relative to the opening region 4A',
particularly of the closure device 23, and only afterwards can the
opening region 4A' of the first connecting arrangement 3A' be
opened by the rotation of the connecting arrangements 3A', 3B'
relative to one another in the manner described. By comparison with
the embodiment in FIGS. 5 to 13, however, in the present case the
holding portion 25 or the mouth-shaped portion 5A' is configured to
pierce the opening region 4B' of the second connecting arrangement
3B'. In this respect, reference is made to the previous
explanations for supplementary information.
[0430] In the present embodiment, by comparison with the previous
embodiment, the piercing and/or cutting edge 32 is provided on the
mouth-shaped portion 5A', as is also possible in the previous
embodiment and advantageous for easier opening of the opening
region 4B' of the second connecting arrangement 3B'.
[0431] In the present embodiment, the opening region 4B' of the
second connecting arrangement 3B' is closed off by an, in
particular, at least substantially rigid, dimensionally stable
and/or plate-shaped closure device 33, particularly a closure plate
or disc, which is preferably sealingly held on the mouth-shaped
portion 5B, particularly by means of a frangible point 34. Other
constructions are also theoretically possible here, for example as
described in connection with FIG. 7. The use of the closure device
33, in a similar manner to the closure of the first connecting
arrangement 3A' with the closure device 23, however, makes it
easier to open the second connecting arrangement 3B' in the opening
region 4B'.
[0432] The piercing and/or cutting edge 32 preferably corresponds
in its orientation and position to the frangible point 34 of the
second connecting arrangement 3B', such that bringing the
connecting arrangements 3A', 3B' together leads to the piercing
and/or cutting edge 32 being applied to the frangible point 34, as
a result of which the frangible point 34 can be severed, starting
at the initial point of application of the piercing and/or cutting
edge 32. Preferably, the connecting arrangements 3A', 3B' are
correspondingly guided to one another.
[0433] The frame 28 and/or the piercing and/or cutting edge 32
preferably has a rounded and/or chamfered portion, so that when the
piercing and/or cutting edge 32 acts on the frangible point 34 the
frangible point 34 is partially spared, so that preferably an
intact part of the frangible point 34 still holds the closure
device 33 against the mouth-shaped portion 5B' after opening,
particularly in the manner of a film hinge. This ensures that the
closure device 33 is not detached and prevents blockage of one of
the removal openings E1, E2.
[0434] In the embodiment shown, in the initial state, the closure
device 33 is aligned with the mouth-shaped portion 5B' at least
substantially perpendicular to the central axis or axis of symmetry
9. It is certainly possible to have an inclined alignment, as with
the closure device 23 of the first connecting arrangement 3A', but
this is not absolutely necessary, as the second connecting
arrangement 3B' is preferably opened primarily by the piercing
and/or cutting edge 32 and not by deformation of the mouth-shaped
portion 5B'.
[0435] The mouth-shaped portion 5B' is preferably sufficiently
stable in its construction and hold so that when the connecting
arrangements 3A', 3B' are rotated after being inserted in one
another, deformation takes place at least substantially or in any
case predominantly in the region of the mouth-shaped portions 5A'
or in the holding portion 25. A certain deformation of the
mouth-shaped portion 5B' and/or the deforming device 30, of the
second connecting arrangement 3B' is possible, however.
[0436] According to a further aspect of the present invention the
container(s) B1, B2 is or are (each) formed from a container blank
BR1, BR2 and the respective connecting arrangement 3A', 3B'. The
same may also apply to the previous embodiment.
[0437] In the embodiment shown the container blanks BR1, BR2 are
upper container or bottle parts, configured for connection to the
respective connecting arrangement 3A', 3B' on a side or end remote
from or opposite to the removal opening E1, E2. In particular, they
are container blanks BR1, BR2 without bases, the resulting open
region being closed off during manufacture by means of the
respective connecting arrangement 3A', 3B' to form the respective
container B1, B2.
[0438] Container blanks BR1, BR2 are thus particularly structures
with a removal opening E1, E2 and another open point which can be
closed off by the respective connecting arrangement 3A', 3B'.
[0439] Preferably, the respective connecting arrangement 3A', 3B'
is tightly connected to a wall of the container blank BR1, BR2 by
material engagement, particularly preferably by welding, adhesive
bonding, injection molding or by some other method. The connecting
arrangements 3A', 3B may consequently be used in all kinds of
containers B1, B2 or may also be used independently of containers
B1, B2, for example in order to fluidically connect a container B1,
B2 to another structure such as a pipe, a connector or the like.
However, the connection of containers B1, B2, B3 to one another is
particularly preferred.
[0440] Preferably, the (respective) connecting arrangement 3A', 3B'
is configured to be connected to the container blank BR1, BR2 so
that a container B1, B2 is formed. It is also preferable that the
container blank BR1, BR2 should have a wall 35A', 35B' with an open
edge 36A', 36B', forming a receptacle for the connecting
arrangement 3A', 3B', into which the respective connecting
arrangement 3A', 3B' can be inserted and tightly connected to the
container blank BR1, BR2.
[0441] In another aspect, the present invention relates to a
connecting system 1 with the first connecting arrangement 3A'
comprising the holding portion 25 and the frangible point 24 and a
second connecting arrangement 3B' comprising the deforming device
30 corresponding to the holding portion 25, wherein the connecting
arrangements 3A', 3B' can be inserted sealingly into one another
and, as the connecting arrangements 3A', 3B' are rotated relative
to one another, as a result of the deformation of the holding
portion 25 by the deforming device 30, the first connecting
arrangement 3A' can be opened in order to produce the fluidic
connection 2.
[0442] In another aspect which may also be implemented
independently, the present invention further relates to one or more
containers B1, B2, B3, particularly bottles (each) having a
connecting arrangement 3A', 3B' according to the present invention,
preferably on a side or end remote from a container opening or
removal opening E1, E2, another connecting arrangement 3A', 3B' or
a base.
[0443] In another aspect which may also be implemented
independently, the present invention further relates to a container
system B with at least two containers B1, B2, B3, wherein a first
container B1 comprises the first connecting arrangement 3A' and a
second container B2, B3 comprises the second connecting arrangement
3B', which corresponds to the first connecting arrangement 3A'.
[0444] The connecting arrangements 3A', 3B' are preferably
configured as described hereinbefore. In particular, it is
preferable for the first connecting arrangement 3A' to have the
piercing and/or cutting edge 32 by means of which the second
connecting arrangement 3B' can be opened.
[0445] Alternatively, or additionally the second connecting
arrangement 3B' comprises the mouth-shaped portion 5B' or the
deforming device 30, for opening the first container B1 by means of
the first connecting arrangement 3A' by deformation of the holding
portion 25 or of the mouth-shaped portion 5A'.
[0446] It is also preferable that the connecting arrangements 3A',
3B' should enable the formation of the fluidic connection 2 by
mutual opening, the first connecting arrangement 3A' opening the
second connecting arrangement 3B' and the second connecting
arrangement 3B' opening the first connecting arrangement 3A', thus
forming the fluidic connection 2.
[0447] In another aspect of the present invention which may also be
implemented independently, the connecting arrangements 3A', 3B' are
used to prepare a mixture of substances, preferably a medicament,
particularly a vaccine or combined vaccine, to produce a fluidic
connection 2 and/or to mix starting materials or substances S1, S2
which have been stored separately.
[0448] The invention further relates to a method, which may also be
implemented independently, for producing one of the connecting
arrangements 3A', 3B' or the connecting system 1 and/or a container
B1, B2, B3, in which the closure device 23, 33, the frangible point
24, 34 and the holding portion 25 or the mouth-shaped portion 5A',
5B' are injection molded in a common step. This has proved
advantageous in terms of reliable production of the frangible point
24, 34.
[0449] In the method, it is also preferable if, in a container
blank BR1, BR2 having an open end, particularly a bottle blank with
a removal opening E1, E2 in addition to the open end, the open end
is sealed off by the separately produced connecting arrangement
3A', 3B'.
[0450] The connecting arrangement 3A', 3B' preferably comprises a
collar-shaped and/or tubular portion 37A', 37B' which delimits the
(respective) connecting arrangement 3A', 3B' radially outwards and
corresponds to the wall 35A', 35B' of the respective container B1,
B2 or container blank BR1, BR2, in order to be inserted therein and
connected to the container blank BR1, BR2.
[0451] Another aspect of the present invention which may also be
implemented independently relates to the sealing concept, based on
a combination of the connecting arrangements 3A', 3B' with one
another, or of one of the connecting arrangements 3A', 3B' with a
preferably cap-like cover device 6, 26.
[0452] It is provided that a container B1, B2, B3 is provided with
a connecting arrangement 3A', 3B' for producing a fluidic
connecting arrangement 2 of the container B1, B2, B3 with another
container B1, B2, B3. In an initial state the connecting
arrangement 3A', 3B' may be fluidically sealed in an opening region
4A', 4B' and can be opened in order to form the fluidic connection
2. The opening region 4A', 4B' is covered with a cap-like cover
device 6, 26 and/or another connecting arrangement 3A', 3B'. This
aspect thus relates particularly to an individual container B1, B2,
B3 or a connecting arrangement therefor, of the container system B
combined with the cap-like cover 6, 26 and/or the (corresponding)
connecting arrangement 3A', 3B'.
[0453] In another aspect which may also be implemented
independently, it is envisaged that the cover device 6, 26 or the
other connecting arrangement 3A', 3B' is sealingly held on the
proposed container B1, B2, B3, thus forming a sealed chamber 38A,
38B, 38C. Moreover, the proposed container B1, B2, B3 comprises a
sealing arrangement 39 surrounding the opening region 4A', 4B'
thereof, which seals off a volume 40A, 40B, 40C of the chamber 38A,
38B, 38C in direct contact with the opening region 4A', 4B'.
Particularly preferably, the sealing arrangement 39 seals off the
inner volume 40A, 49B, 40C from an outer volume 41A, 41B, 41C of
the chamber 38A, 38B, 38C. This advantageously covers the opening
region 4A', 4B', particularly by means of a double closure. This
enhances the barrier preventing the ingress of substances,
particularly germs.
[0454] It is provided, in particular, that foreign substances can
only reach the inner volume 40A, 40B, 40C by passing through the
outer volume 41A, 41B, 41C. The sealing arrangement 39 is
preferably mechanically decoupled from the environment by an outer
seal of the cover device 6, 26, so that any force acting on the
cover device 6, 26 may affect the tight seal of the outer volume
41A, 41B, 41C, but the inner volume 40A, 40B, 40C will remain
sealed even in such a case, preferably in airtight manner,
particularly in germproof or bacteria-proof manner. In this way it
is possible to guarantee a sterile environment at the opening
region 4A', 4B'.
[0455] Alternatively, or additionally the sealing arrangement 39
seals off the inner volume 40A, 40B, 40C surrounding the opening
region 4A', 4B' by means of the cover device 6, 26 or the other
connecting arrangement 3A', 3B' when there is uninterrupted
movement of the cover device 6, 26 or the other connecting
arrangement 3A', 3B' relative to the connecting arrangement 3A',
3B' of the proposed container B1, B2, B3. In this way, during the
process of inserting the connecting arrangements 3A', 3B' into one
another and/or during the assembly or removal of the cover
device(s) 6, 26, the opening region 4A', 4B' can be protected from
the ingress of foreign substances, particularly germs.
[0456] It is particularly preferable to combine the two aspects,
i.e. to form the chamber 38A, 38B, 38C, which is divided by the
sealing arrangement 39 into an inner volume 40A, 40B, 40C and an
outer volume 41A, 41B, 41C, the sealing arrangement 39 being
configured to prevent the ingress of foreign substances,
particularly germs, into the inner volume 40A, 40B, 40C, during, in
particular, axial movement of the cover device 6, 26 or other
connecting arrangements 3A', 3B'.
[0457] The sealing arrangement 39 preferably comprises sealing
portions 42A, 42B, 43A, 43B corresponding to one another, a first
sealing portion 42A, 42B being associated with the connecting
arrangement 3A', 3B' and a second sealing portion 42A, 42B, 43A,
43B being arranged on the cover device 6, 26 and/or on the other
connecting arrangement 3A', 3B', particularly being formed in one
piece therewith.
[0458] The sealing portions 42A, 42B, 43A, 43B preferably comprise
sealing surfaces 44A, 44B, 45A, 45B corresponding to one another,
which abut closely on one another when the cover device 6, 26 is
placed on the connecting arrangement 3A', 3B' or the connecting
arrangements 3A', 3B' are fitted into one another.
[0459] The sealing surfaces 44A, 44B, 45A, 45B preferably have a
similar shape in cross-section (perpendicular to the central axis
or axis of symmetry 9) and/or are round and/or rotationally
symmetrical to the common axis of symmetry and/or central axis
9.
[0460] Preferably, the sealing portions 44A, 44B, 45A, 45B are
configured and/or correspond to one another such that it is
possible to rotate the cover device 6, 26 and/or the other
connecting arrangement 3A', 3B' relative to the container B1, B2,
B3.
[0461] Preferably, one of the connecting arrangements 3A', 3B'
comprises a sealing surface 44A, 44B, which corresponds to both the
sealing surface 44A, 44B of the other connecting arrangement 3A',
3B' and to the sealing surface 45A, 45B of the cover device 6, 26
corresponding to the connecting arrangement 3A', 3B'. The sealing
arrangement 39 may thus be formed on the basis of a connecting
arrangement 3A', 3B' both with the corresponding cover device 6, 26
and with the other connecting arrangement 3A', 3B'. In this way it
is possible to obtain a seal over the cover device 6, 26 during
transporting and over the other connecting arrangement 3A', 3B'
during use, using the same means or re-using the same means.
[0462] Another aspect of the present invention, which may also be
implemented independently, relates to the connecting system 1 for
producing the fluidic connection 2 between the containers B1, B2,
B3 and/or a container B3, the connecting system 1 or the container
B3 having at least two connecting arrangements 3A', 3B' configured
to produce the fluidic connection 2, namely a first connecting
arrangement 3A' and a second connecting arrangement 3B', which are
each fluidically sealed in an initial state or fluidically close
off the container B1, B2, B3 and can be opened in an opening region
4A', 4B' in order to produce the fluidic connection 2.
[0463] In another aspect it is provided that the connecting
arrangements 3A', 3B' form the sealed chamber 38C and comprise the
sealing arrangement 39, while a volume 40C in direct contact with
the opening regions 4A', 4B' is sealed off from a volume 41C of the
chamber 38C separated from the opening regions 4A', 4B' by means of
the sealing arrangement 39.
[0464] Alternatively, or additionally the connecting system 1
comprises a sealing arrangement 39 which uninterruptedly seals off
a volume 40C in direct contact with the opening regions 4A', 4B' as
the connecting arrangements 3A', 3B' are moved relative to one
another.
[0465] It is also preferable if the connecting arrangement 3A', 3B'
comprises at least two positions for connection to one another,
which are occupied one after the other in terms of time and
location when the connecting arrangements 3A', 3B' are pushed or
fitted into one another. In the first connecting position, a
non-releasable connection is made between the connecting
arrangements 3A', 3B' and the fluidic connection 2 is only
produced, or able to be produced, in the second connecting
position. For further details, reference may be made to the
previous embodiments.
[0466] It is particularly preferable that the sealing arrangement
39 seals or closes off the inner volume 40C without interruption in
the first connecting position, in the second connecting position
and between the first and second connecting positions and/or seals
or separates the inner volume 40C from the outer volume 41C without
interruption.
[0467] For further details of the connecting system 1 in connection
with the sealing arrangement 39, reference is made to the previous
discussion in particular with regard to the sterile or sterilizable
covering in connection with, e.g., FIGS. 16, 17 and 20 and/or in
connection with the proposed container B1, B2, B3 with the sealing
arrangement 39.
[0468] Another aspect of the present invention, which may also be
implemented independently, relates to a connecting arrangement 3A',
3B' and/or a container B1, B2, B3 having this connecting
arrangement 3A', 3B', wherein the opening region 4A', 4B' of the
connecting arrangement 3A', 3B' is fluidically closed in an initial
state and can be opened to form the fluidic connection 2. In this
aspect, the connecting arrangement 3A', 3B' comprises a cover
device 6, 26, which can preferably be latched to the container B1,
B2, B3 or the connecting arrangement 3A', 3B' and/or is in the form
of a cap and/or is removable, and which covers the opening region
4A', 4B'.
[0469] The cover device 6, 26 according to this aspect preferably
comprises a support portion 46 which corresponds to the opening
region 4A', 4B' and is directly or so closely adjacent to the
opening region 4A', 4B' that a force FS acting on the opening
region 4A', 4B' in the direction of the support portion 46 is
absorbed by the contact of at least part of the opening region 4A',
4B' on the support portion 46 such that opening of the opening
region 4A', 4B' is prevented.
[0470] In another aspect, which may also be implemented
independently, the invention relates to the use of the connecting
arrangements and/or containers for mixing viscous liquids,
particularly vaccines, preferably with a dynamic viscosity at
23.degree. C. and a shear rate of 1 s.sup.-1 (particularly measured
in the Brookfield viscometer RVT with spindle no. 4) of more than
1.5 or 2 Pa-s (pascal second), preferably more than 4 Pa-s,
particularly more than 6 Pa's or 10 Pa-s, and/or less than 100
Pa-s, particularly less than 70 Pa-s, preferably less than 50 Pa-s,
and/or in the range from 1 Pa-s to 100 Pa's, particularly from 2
Pa-s to 70 Pa's, preferably from 5 Pa-s to 50 Pa-s. The viscosities
specified above within the scope of the present invention may be
determined in particular by the method according to EN ISO
2884-1:2006. Viscous liquids in particular benefit from the large
hydraulic minimum cross-section of the connection compared with the
known solutions.
[0471] The aspects of the present invention can be combined with
one another. In particular, aspects of the embodiments from FIGS. 1
to 20 may also be used accordingly in the embodiment according to
FIGS. 21 to 37 and vice versa.
[0472] For example, the aspects relating to the sealing arrangement
39 and/or the support portion 46A, 46B may also be present in the
cover device 6 from the embodiments in FIGS. 1 to 20. The cover
devices 6, 25 may make it possible to obtain an, in particular,
repeated or multi-stage sterile and/or sterilizable closure, while
the aspects explained in connection with FIG. 17 can be combined
with the aspects concerning the sealing arrangement 39, which were
described in connection with FIGS. 22 to 34. Alternatively, or
additionally, the aspects relating to the deformation-based opening
as explained in connection with FIGS. 6 to 15 can be combined with
aspects relating to the closure device 33 or vice versa. These
examples make it clear that there are numerous preferred
combinations of aspects which may form the subject of the present
invention even if the combination is not expressly described.
[0473] In one aspect, which can be realized independently as well,
the container system B having at least two containers B1, B2, B3 is
provided, wherein the container system B or at least one of said
containers B1, B2, B3 comprises a light member L1 to L6 which is
configured to provide information through the emission of light
LE.
[0474] In the examples shown, emitted light LE is indicated next to
the light members L1 to L6 when the light members L1 to L6 emit
light or provide information through the emission of light.
[0475] The container system B preferably is configured to provide
or trigger the light member L1 to L6 to provide information through
the emission of light LE when a step which is directly related to
preparing a mixture of contents, in particular substances S1, S2,
of the containers B1, B2, B3 is conducted.
[0476] As depicted in FIG. 1, a first container B1 can comprise a
light member L1 which has already been triggered as a mixture of
contents or substances S1, S2 has already been prepared using the
container system B. In the example shown, the light member L1
radiates emitted light LE.
[0477] Alternatively, or additionally, as shown in FIG. 1 as well,
the second container B2 can comprise a light member L2, which, in
the example shown, has already been triggered and radiates light LE
as well.
[0478] One or more of the light elements L1 to L6 can be triggered
by means of deformation or depression of the light element L1 to L6
or of parts thereof.
[0479] FIG. 2 shows the containers B1, B2 at the beginning of the
process for preparing the fluidic connection 2. The light members
L1, L2 have not been triggered yet in the example shown.
[0480] The light member L1 of the first container B1 comprises a
first chemical component LC1 and second chemical component LC2
which are separated from one another by a separator LS.
[0481] A section of the light member L1 is arranged such that it is
(automatically) depressed when the fluidic connection 2 is
prepared. Depressing said section of the light member L1 triggers
the light member L1.
[0482] The first and second chemical components LC1, LC2 preferably
are mixed or come into contact generally by triggering a light
member L1 to L5, in the present embodiment by depression of the
section of the light member L1. The depression can rupture of the
separator LS which in an initial state, as shown in FIG. 2,
separates the first and second chemical components LC1, LC2. In
FIG. 4, the light member L1 has been triggered by depression of the
section of the light member L1.
[0483] It is not necessary that said section of the light member L1
is able to provide the information through the emission of light LE
but it may be sufficient for this section to trigger the light
member L1.
[0484] In the example shown, said section comprises or forms a
cavity like a pocket containing the first chemical component LC1.
Said cavity is separated from an area of the light member L1
comprising or containing the second chemical component LC2 by
separator LS. The light member L1 is configured such that, when
this cavity is depressed, the separator LS opens or ruptures, thus
causing the first chemical component LC1 to come into contact with
the second chemical component LC2. Caused by the first chemical
component LC1 coming into contact with the second chemical
component LC2 the light element L1 can be triggered and/or emit
light LE.
[0485] Preferably, said section is arranged at a face end of the
first container B1, such that the section comes into contact and is
(automatically) depressed by the second container B2 during
preparation of the fluidic connection 2. In particular, the section
of the light member L1 is configured and/or arranged to be
automatically depressed when the connecting arrangements 3A, 3A',
3B, 3B' are moved or plugged into one another for preparing the
fluidic connection 2.
[0486] Each of the light members L1 to L5 might comprise one or
more chemical components LC1, LC2 that can be triggered to emit
light LE, even if not explicitly mentioned or depicted in the
following. Generally, triggering preferably means or comprises
bringing said chemical components LC1, LC2 into contact or
initiating a different measure like providing a crystal nucleus or
switching a source causing a chemical component LC1, LC2 or
different light source to emit light LE.
[0487] The light member L2 of the second container B2 of the bottle
system as depicted in FIG. 1 is triggered differently. Here, a
trigger element LT2 acts on or deforms the light member L2 when the
fluidic connection 2 is prepared.
[0488] As shown in FIG. 2, the trigger element LT2 is configured to
act on the light member L2 when the connecting arrangements 3A, 3B,
3A', 3B' are moved or plugged into each other. In the example
shown, the trigger element LT2 is realized by a pin which is
arranged moveable through a wall of the second container B2 or
through a collar-like portion 22 of it such that pressure can be
transferred by the trigger element LT2 on the lighting member
L2.
[0489] Preferably, the trigger element LT2 on a side remote from
the light member L2 of the wall or collar-like portion 22 of the
container B2 protrudes the wall or the collar-like portion 22 such
that, during preparation of the fluidic connection 2, in particular
when the first connecting arrangement 3A, 3A' is inserted into the
second connecting arrangement 3B, 3B', the trigger element LT2 is
pressed towards the light member L2, whereby the light member L2 is
triggered. In particular, the light member L2 is triggered by
deformation such that separator is ruptured or causing a different
trigger means to start a reaction that causes the lighting member
L2 to emit light LE.
[0490] In the example shown, the light member L2 comprises a
trigger member LA2 which is configured for starting and/or changing
the emission of light by means of the light member L2 if the
trigger member LA2 is pressed. The trigger member LA2 can be broken
by means of the trigger element LT2 when it is moved towards the
light member L2. This preferably causes chemical components LC1,
LC2 (not shown) to come into contact or to start a chemical process
for emitting light LE by the light member L2.
[0491] In the example shown, the trigger member LA2 preferably is
frangible or brittle. Further, in the example shown the trigger
member LA2 is flat, a plate or disk-like. The trigger member can be
configured to trigger the light member L2 or start it to provide
information by the emission of light LE when deformed, ruptured
and/or destroyed. However, the trigger member LA2 alternative or
additionally can contain and separate a chemical component from a
different chemical component of light member L2 such that
destroying said trigger member LA2 causes the light member L2 to
provide the information and/or to emit light.
[0492] The light member L2 can alternatively or additionally be
triggered by means of a different trigger element LT2' which can be
driven by means of or caused by a rotational movement of the
connecting arrangements 3A, 3B, 3A', 3B' relative to one another
and/or by deformation of mouth-shaped portions 5A, 5A', 5B, 5B' of
the connecting arrangements 3A, 3B, 3A', 3B'.
[0493] As depicted in FIGS. 9 and 11 to 13, the trigger element
LT2' is or comes into contact with the mouth-shaped portion 5B'
which is deformed when the fluidic connections 2 is prepared, such
that the trigger element LT2' is moved towards and, thus, triggers
the light member L2.
[0494] A trigger element LA2' which is configured to trigger the
light element L2 in this embodiment can comprise a cavity which can
automatically open when the trigger element LT2' presses thereon.
This can cause chemical components to mix which allows providing
the information by emission of light LE.
[0495] However, there might be different options to drive a trigger
element LT2, LT2' such that the trigger element LT2, LT2' acts on
to the light member L2 in a manner that the light member L2 is
triggered.
[0496] In FIG. 14, a different kind of container B3 of the
container system B is depicted, wherein a light member L3 can be
triggered as previously discussed referring to the first container
B1 or, as depicted in FIG. 14, as discussed referring to the second
container B2.
[0497] In FIG. 16, further different options to realize light
members L4, L5 are shown. In FIG. 16, the containers B1, B2 of the
container system B are arranged in a transport configuration or
connected for transport purposes, in particular forming a kit.
[0498] The first and second containers B1, B2 preferably are
assigned to one another or connected to one another in the initial
state before starting any steps for preparing the mixture, said
initial state also referred to as transport configuration.
[0499] In the example shown, the second container B2 at least
partially is arranged and/or held inside the first container B1 or
a cover device 6 thereof, the cover device 6 preferably having a
receptacle for uptaking the bottleneck of the second container
B2.
[0500] A light member L4 is arranged and configured in such a way
that separating the containers B1, B2 from one another triggers the
light member L4. In particular, the light member L4 is arranged on
one of the containers B1, B2 and connected to the other one of the
containers B1, B2 in a manner that separating the containers B1, B2
from one another causes deformation, in particular stretching, of
the light member L4, by means of which the light member L4 is
triggered. This can be achieved by direct connection, using a
pull-tab or the like. However, different triggering mechanisms
might be used alternatively to, preferably automatically, trigger
the light member L4 when the containers B1, B2 are separated from
one another.
[0501] One or more of the containers B1, B2, B3, in the example
depicted in FIG. 16 the first container B1, can comprise a cover
device 6 for covering a (the first) connecting arrangement 3A, 3A'
or opening region 4A, 4A', where the cover device 6 needs to be
removed in order to facilitate preparation of the fluidic
connection 2.
[0502] A light member L5 can be arranged on the first container B1
and/or on the cover device 6 and can be configured such that
removing the cover device 6 from the first container B1 or the part
of the first container B1 comprising the component or substance S1
triggers the light member L5. In the example shown, the light
member L5 is arranged on the cover device 6, but it can
alternatively or additionally be arranged on the wall of the first
container B1.
[0503] The light member L5 is arranged such that separating the
container B1 from its cover device 6 (automatically) causes the
light member L5 to be triggered. In particular, the light member L5
is automatically bended, stretched, deformed or acted on in a
different way such that the light member L5 is triggered.
[0504] The light members L1 to L5 in the present embodiments
preferably are labels or label-like, although differently formed
light members are possible alternatively or additionally.
[0505] In a further embodiment, a light member L6 as depicted in
FIG. 16 might form part of the container B1 to B3 or cover device 6
and might have a housing which can be stable in form or rigid. Said
light member L6 might be triggered by means of a trigger element,
by deformation, tension or the like. In the embodiment shown in
FIG. 16, the light member 16 detects a step like disassembly of the
cover device 6 by means of a device which is configured to change
an electrical contact like a switch or sensor. Light member L6 can
alternatively or additionally be arranged at a different position
or part of the container system B.
[0506] The light members L1 to L6 do not necessarily produce light
by means of chemical effects although this is preferred. One
alternative is providing, using and/or controlling an electrical
light source like an LED.
[0507] The container system B has been described with multiple
light member L1 to L6 that can be (automatically) triggered by
means of different triggering mechanisms. However, only one, two,
three or four light members L1 to L6 might be provided. Further,
light members L1 to L6 can be arranged at different positions and
triggered in different manner, i.e., the triggering mechanisms can
be exchanged or replaced.
[0508] In particular, light members as described later referring to
FIG. 23 ff. can be triggered like light members L1 to L6 or
differently, preferably automatically by means of a step being in
direct relation to or has to be performed for preparation of the
fluidic connection 2.
[0509] In one further embodiment, one or more of the light
member(s) L1 to L6 can be configured to be triggered when being
stretched, bended or deformed. In particular, light member L1 to L6
can be connected to the container B1, B2, B3 and configured in such
a way that this stretching during preparation of the fluidic
connection 2 of the container B1 to B3 causes the light member L1
to L6 to be triggered.
[0510] Such one or more of the light member(s) L1 to L6 extends
through a region of a container B1, B2, B3 of the container system
B which is stretched, bended or deformed during preparation of the
fluidic connection 2. For example, the light member L2 as shown in
FIG. 2 or 5 can be stretched by means of obstacles like security
elements 10B being displaced during preparation of the fluidic
connection 2.
[0511] In FIG. 5 there is at least one securing device 10B or a
different part or obstacle of the second container B2 which has a
structure, like a slope, which is (automatically) moved or bended
towards the light member L2 in order to enable triggering the light
member L2 by pressure or deformation when the fluidic connection 2
is prepared, which can trigger the light member L2 alternatively or
additionally to triggering by means of trigger element LT1 and/or
trigger member L2.
[0512] Generally, steps being in direct relation to preparation of
the fluidic connection 2 which can cause (automatic) triggering one
or more light elements L1 to L6 can be or cover, but are not
necessarily limited to one or more of: [0513] depackaging the
container system B or containers B1, B2, [0514] separating the
containers B1, B2 from one another, [0515] removing one or more
cover devices 6 from containers B1, B2 or connecting arrangements
3A, 3B, 3A', 3B', [0516] moving the containers B1, B2 or connecting
arrangements 3A, 3B, 3A', 3B' towards or into each other, [0517]
inserting one of the containers B1 to B3 or connecting arrangements
3A, 3B, 3A', 3B' into another one of the containers B1, B2, B3 or
connecting arrangements 3A, 3B, 3A', 3B', [0518] turning containers
B1, B2 or connecting arrangements 3A, 3B, 3A', 3B' relative to each
other, and [0519] piercing and/or rupturing and/or deforming one or
more opening regions 4A, 4A', 4B, 4B'.
[0520] Triggering one or more light members L1 to L6 preferably
causes the triggered light member L1 to L6 to emit light LE,
preferably to start emission of light LE which can indicate or
provide the information that a mixture is viable or deemed to be
viable.
[0521] Alternatively or additionally, triggering the light member
L1 to L6 not immediately causes starting emission of light LE but
may cause a delayed start of light emission, i.e., light emission
in order to provide information after a period of time which might
be related or correspond to a period of time a mixture formed from
the contents or substances S1, S2 contained in the containers B1 to
B3 is or is deemed to be viable.
[0522] Alternatively, or additionally, the light member(s) L1 to L6
can be configured to stop emitting or change properties of emitted
light LE after the period of time has expired that corresponds to a
time span or the period of time the mixture of contents or
substances S1, S2 remains or is deemed viable. This can provide
information that the mixture shall not be used anymore.
[0523] For example, the chemical components LC1, LC2 which are used
to produce the light LE can be configured or a structure or
properties of the light member(s) L1 to L6 can be arranged such
that emission of light LE stops after the period of time.
[0524] In one example, the light member L1 to L6 emits light over
at least essentially the whole light member L1 to L6. Alternatively
or additionally, the light member L1 to L6 can be configured or
structured in a way that only a section or part of the light member
L1 to L6 emits light LE at each time, wherein the section may be
continuously changed or moved such that light emitting sections
virtually move over the light member L1 to L6 over the period of
time.
[0525] Consequently, the light member L1 to L6 preferably realizes
a counter, timer or clock allowing (automatic) indication of the
period of time over which the mixture remains or is deemed to
remain viable. However, there might be different approaches to
provide such information regarding the period of time or its expiry
which preferably is triggered by a step which directly relates to
the process of preparation of the fluidic connection 2.
[0526] Alternatively, or additionally to starting or stopping
emission of light, one or more light members L1 to L6 might be
configured to change properties of the emitted light LE with or
after expiry of the period of time. In particular, the color of the
emitted light LE might be changed and/or, as already indicated, the
position at which the light member L1 to L6 emits light may
change.
[0527] In a combination of these aspects, differently colored light
can be emitted by one or more of the light members L1 to L6
generated by a varying or moving section of the light member L1 to
L6 over the period of time.
[0528] Emission of light LE in the sense of the present invention
particularly preferably relates to or is active radiation of
electromagnetic waves having one or more wave lengths in the range
being visible for human eyes, in particular by means of
chemoluminescence. Alternatively, or additionally, light LE can be
emitted by means of fluorescence or phosphorescence, where energy
is absorbed and re-transmitted in a different wavelength and/or at
a different or spread over time. Although active emission of light
is preferred, alternatively or additionally passive emission of
light is possible as well, wherein the light member L1 to L6 for
example can change reflection or absorption properties with respect
to light such that the information, in particularly regarding the
period of time, is provided optically.
[0529] In the following, the invention is further described
generally related to packages, which, however, can comprise or be
realized by one or more containers B1, B2, B3, wherein the
containers B1, B2, B3 can comprise connecting arrangements 3A, 3A',
3B, 3B' even if neither depicted nor explicitly mentioned.
[0530] In the following, further examples, in particular the
position, shape and/or properties of light members are discussed in
further detail referring to FIG. 23 ff. Even if triggering light
members might not be described or might be described differently
with respect to those embodiments, alternatively or additionally
such light members described in the following can be triggered as
previously described, in particular automatically by means of a
step which is or the connecting system 1 demands for to be
conducted in order to prepare the fluidic connection 2 and/or to
mix up the contents/substances S1, S2 contained by the containers
B1 to B3. For example, light members being arranged at or
surrounding a removal opening like a vial can be triggered
automatically when the removal opening like a vial is removed from
an uptake 13.
[0531] The packages and methods disclosed herein overcome the
limitations present in presently available packages including
medicaments and meet one or both of the unmet needs disclosed
herein; that is, the packages and methods disclosed herein address
either the need to provide the end-user with information regarding
the viability of the medicament being administered to the animal or
to assist the farmer with the visibility of a package under low
light conditions. In some embodiments, the packages and methods
disclosed herein overcome both unmet needs simultaneously.
[0532] A large variety of packaging types are known for use in
medicinal applications and products. Examples of known packages
include, but are not limited to, bottles, boxes, vacuum packs, and
bags. The embodiments disclosed herein are suitable when applied to
any type of package. Desirably, the package is for medicinal
products or a medicament, and is a bottle. In another embodiment,
the package is desirably a box in which the medicament is stored,
shipped, or otherwise packaged prior to delivery to the end-user.
In one non-limiting example, the package is a box that contains
multiple bottles of a medicament that are delivered to a farmer or
veterinarian. The multiple bottles of medicament inside the box may
or may not have an individual light member for each individual
bottle.
[0533] Some packaging for use with a medicament that requires
regulatory approval will also be subject to regulatory requirements
as determined under appropriate national authority, for example, by
the United States Food and Drug Association. The light member
disclosed herein, when integrated into to the label or exterior
adornment of a package, will meet any required regulatory
requirements if necessary. In some embodiments, there are no
regulatory requirements that would apply to the light member. In
other embodiments, there are regulatory requirements that apply to
the light member.
[0534] In some embodiments, the package comprises a medicament, and
the package comprises a light member that is configured to provide
information to the end-user. The light member may be attached to
the package when activated to produce light; or the light member
may be activated to produce light and then subsequently attached to
the package. In other embodiments, the light member may be
activated to produce light and simply placed next to the package.
The end-user may be a farmer, farm worker, veterinarian,
veterinarian technician, or any individual who is providing medical
treatment for an animal. In some desirable embodiments, the package
is a bottle comprising an animal vaccine. In some embodiments, the
bottle comprising the animal vaccine is suitably shaped and size
for use with an animal vaccination gun. In some other embodiments,
the information provided to the end-user is simply the location of
the package or a specific part of the package under low light
conditions. In some aspects, the information provided to the
end-user is about the viability of the medicament inside the
package. In some other aspects, the information provided is both
regarding the viability of the medicament inside the package and
the location of the package or specific part of the package under
low light conditions.
[0535] In yet another aspect, the light member is part of a kit.
The kit comprises at least one package comprising a medicament and
at least one light member. The medicament and the light member can
be any embodiment disclosed elsewhere herein. As one non-limiting
example, the kit comprises two different vaccines for two different
medical conditions. Included in said kit are two different colored
light members.
[0536] One white LED light member as described in FIG. 33 is
included to enhance the visibility of the septa on the serum cap,
and each vaccine comprises a light member as described in FIG. 30
already attached to the bottle wherein one vaccine has a green
light member and the other vaccine has a yellow light member.
However, different colors or differently operated light members can
be used alternatively or additionally.
[0537] Informational material in the form of written instructions
may be included in the kit. Said written instructions may include
any relevant information in relation to the kit, including, but not
limited to, the manner in which to actuate the light members and
instructions relating the length of time that the light member
remains visible to the viability of the medicament.
[0538] As another non-limiting example, the kit comprises a box
with a fluorescent label; inside the box there is at least one
bottle comprising a vaccine and at least one light member as
illustrated in FIG. 29. The light member has a "peel and stick"
adhesive that can be used to attach the light member to the bottom
of the vaccine bottle. The light member is activated by pinching it
forcefully enough to rupture the internal separator for the
chemicals inside once the vaccine is either reconstituted or
removed from refrigerated storage. Activation may be either prior
to attaching to the bottle or any time thereafter as desired by the
end-user.
[0539] The medicament in the package is not limited and may be any
medicinal product. In some embodiments, the medical product has a
limited viability when it is either reconstituted or removed from
refrigerated storage. In some other embodiments, the medicament is
a veterinary product selected from the group consisting of
immunogenic compositions, antibiotics, vaccines, nutritional
supplements, growth supplements, antifungal medication,
anti-parasitic medication, hormones and combinations thereof. In
many embodiments, the medicament is a vaccine such as, for example
a vaccine for BVD including Bovela.RTM..
[0540] In many embodiments described herein, the signal to the
end-user is in the form of emitted light. The light source may be
fluorescence, chemiluminescence or a light emitting diode, and may
be active or passive in nature. The light source is a light member
that emits light upon actuation and is either integrated into
external adornment of the package or is able to be attached to the
exterior of the package by any suitable method, as noted above.
[0541] In some embodiments, the fluorescence is passive
illumination. In such an aspect, the light member may be either
combined with or separate from the label on the package. The light
member may be fully or partially incorporated into the label of the
package. In another aspect, the light member may be a separate
structure that is attached to the package by the end-user at a
designated time in a designated manner. In another aspect, the
light member may be attached to the package prior to delivery to
the end-user. For a passively light member, the fluorescence is
activated by placing the light member under a light source for a
predetermined period of time. Such light source may be artificial
(e.g., a light bulb) or natural (e.g., the sun).
[0542] In some embodiments, the fluorescence is active
illumination. In such an aspect, the light member may be either
combined with or separate from the label on the package. The light
member may be fully incorporated into the label of the package. In
another aspect, the light member may be a separate structure that
is attached to the package by the end-user as a designated time in
a designated manner. In another aspect, the light member may be
attached to the package prior to delivery to the end-user. For an
actively light member, in some aspects, the fluorescence is
activated by the mixing of two or more precursor chemicals. Such
arrangements are known in the art. For example, a separator inside
the light member can keep the precursor chemicals separate. Upon
rupture of the separator, the precursor chemicals mix resulting in
a fluorescent reaction. Rupture can be caused by exerting force on
the separator in the form of shaking, compression or bending. As a
non-limiting example, the light member can be compressed by the end
user thereby causing the rupture of the separator which permits
mixing of the precursor chemicals. In another aspect, when the
light member comprises an LED, actuation is done using an actuation
switch on the LED that comprises at least two settings--on and off.
As non-limiting examples, actuation of the LED can be by a
mechanical action such as twisting, turning, or compression of the
actuation switch.
[0543] In some embodiments, the light member is not affixed to the
package prior to delivery to the end user. Either subsequent to,
coincident with or shortly after actuation of the light member, the
light member can be attached to the package. In another aspect, the
light member is activated, but the light member is not attached to
the package. Attachment may be permanent or temporary. If the
attachment is temporary, removal of the light member can be done
such that the light member is preserved for use on another package.
Methods of attachment are not limited and may include an adhesive
(e.g., glue), tape, and the like. In some embodiments, attachment
of the light member involves inserting the package into a sleeve or
band that comprises the light member. Methods of attachment are
known in the art, and any method of attachment that does not
interfere with the light emitted by the light member or the
contents of the package is acceptable. In some embodiments, the
attachment is via a "peel and stick" method, whereby a protective
cover is removed from an adhesive on one part of the light member,
and the exposed adhesive is pressed against the package in any
suitable location. In another non-limiting example, the light
member has a dry glue on part of one surface that is moistened to
render the glue sticky. As another example, the light member
(described in FIGS. 6 and 27 below) in the form of a sleeve can be
slid on and off of the package and readily placed on another
package. In another embodiment, the light member is in the form of
a fluorescent paint that is coated onto the package prior to
delivery or sale to the end-user. The fluorescent paint would not
affect the contents of the package or pose health and safety risks
to the animals or the end-user.
[0544] Fluorescence and chemiluminescence are known to be transient
processes that last for a limited period of time. They have a
finite lifetime that can be controlled based on careful selection
of the materials and chemicals involved. In some aspects, the time
period that the fluorescence lasts is from 1 to 100 hours and all
integral values in between, specifically including 1 hour, 2 hours,
3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, and
10 hours. In some embodiments the fluorescence is tailored to last
for a predetermined period of time that is matched to some property
of the medicament inside the package. In one desirable embodiment,
the property of the medicament is the length of time it remains
viable after reconstitution or removal from refrigerated storage.
In some embodiments, the light members emits light for 1 hour, 2
hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9
hours, 10 hours, 11 hour, 12 hours, 13 hours, 14 hours, 15 hours,
16 hours, 17 hours, 18 hours, 19 hours, 20 hours, 25 hours, 30
hours, 35 hours, 40 hours, 45 hours, 50 hours, 55 hours, 60 hours,
65 hours, 70 hours, 80 hours, 90 hours, or 100 hours after
actuation.
[0545] It is known that some medicaments have limited viability
after reconstitution or removal from refrigerated storage. In some
embodiments, the length of time that the light member emits light
is matched as closely as possible to the time period that the
medicament remains viable. As a non-limiting example, some animal
vaccines are viable for 8 hours after reconstitution or removal
from refrigerated storage. As such, the time period that the light
member continues to emit light would be 8 hours. When light is no
longer emitted from the light member, the end-user would know that
the medicament was no longer viable and should not be used. It is
understood that the time period that a medicament remains viable
after reconstitution or removal from refrigerated storage may vary
depending on the environmental conditions the medicament is kept
and/or the manner in which it is used. The time period that the
light member continues to emit light would be determined based on
the instructions included with the medicament.
[0546] In some embodiments two or more light members are used
simultaneously for one package. Each light member may be the same
or different. Each light member may have a different color or time
period for which light is visible. For example, two different
colors with two different time periods may be used to provide
different information to the end-user. The color of the light
member is not limited and may be any color visible to the human
eye. Examples include, but are not limited to, white, red, orange,
yellow, green, blue, indigo and violet. Different shades and
intensities are also not limited. They are selected based on the
desired characteristics of the light member. Additionally, one or
more light member may be used that changes color after a specific
time period to provide information to the end user (such as that
the medicament is no longer viable, etc.).
[0547] In one non-limiting example, a red light member on the serum
cap of a bottle (as shown in FIG. 23 discussed below) is used to
assist the end-user in properly locating the septa for syringe
access to the medicament while a second green light member is
attached to the side of the package (as shown in FIG. 30 discussed
below) to indicate the viability of the medicament inside the
package. In embodiments with more than one light member, each light
member may individually be active or passively illuminated, and may
individually be integrated into the package or attached to the
external adornment of package. Each light member may be the same or
different in color. Each light member may use a different source of
light.
[0548] In another non-limiting example, a light member using an LED
light source (as shown in FIG. 33 discussed below) is attached to
the serum cap of the package to assist the end-user in locating the
septa under low light conditions while an active chemiluminescent
light member having a light time period of 8 hours (as shown in
either FIG. 29 or 30 discussed below) is activated upon
reconstitution of a medicament that is known to have 8 hours of
viability after reconstitution. After the 8 hour time period
elapsed and the chemiluminescent light member is no longer visible,
any remaining medicament would be discarded. The LED light member
would be removed, deactivated, and either placed on a new bottle of
medicament or saved for future use.
[0549] In another non-limiting example, the label of a package for
a first medicament comprising a green light member and the label of
a different package for a second medicament comprising a red light
member are used simultaneously under low or poor lighting
conditions. The color difference would allow identification of each
medicament where one group of animals is given the first medicament
and a second, different group of animals, is given the second
medicament. Such color differentiation could be combined with a
different color marking directly on the animal, for example, a
non-toxic paint or dye, to help determine which animals have been
given which medicament.
[0550] Also disclosed herein is a method for determining the
viability of a medicament in a package. The method comprises
actuating the light member as described elsewhere herein when the
package comprising the medicament is initially opened or brought
into use and observing the loss of fluorescence after a
predetermined period of time. The complete loss of fluorescence
indicates that the medicament is no longer viable. In some
embodiments, the light member is attached to the package prior to
actuation. In some embodiments, the light member is activated and
then attached to the package by the end-user.
[0551] A package comprising a medicament and the light member is
considered to be opened or brought into use when the end-user
prepares to administer the medicament to an animal or animals. In
some embodiments, the package is removed from refrigerated storage
and allowed to warm to ambient temperature. Refrigerated storage
does not suggest or require any specific temperature, only that the
temperature be below standard ambient temperature, usually
25.degree. C., in order to preserve the medicament for an extended
period of time prior to use. Some forms of refrigerated storage are
below the freezing point of the medicament, including below
0.degree. C. In some embodiments, opening or bringing into use
means that a solid is reconstituted with a liquid such that the
resulting solution can be administered to an animal via syringe,
vaccination gun, or similar method. Other means of opening and
bringing into use are known and will be specific to the medicament
and the steps necessary before it can be administered to an animal
or animals. This is non-limiting and illustrated herein only by way
of example. Other means as are known in the art are also
encompassed herein.
[0552] Activation of the light member can be by causing two or more
precursor chemicals to mix inside the light member. For example, a
separator inside the light member can keep the precursor chemicals
separate. Upon rupture of the separator the precursor chemicals mix
resulting in a fluorescent reaction. Rupture can be caused by
exerting force on the separator in the form of compression or
bending. As a non-limiting example, the light member can be
compressed or bent by the end user thereby causing the separator to
rupture which causes mixing of the precursor chemicals.
[0553] In some other embodiments, actuation of the light member is
done by exposing the light member to light for a set time period.
The light may be may be man-made (e.g., a lightbulb) or natural
(e.g., sunlight). The set time period to activate the light member
will vary depending on the nature of the light member and the
length of time the end-user desires the fluorescence to continue.
Instructions for actuation for these embodiments, including the set
time period required for actuation, would be included with the
package and the light member.
[0554] The Figures included herein illustrate one desirable
embodiment of the package that comprises a light member--a bottle
with a serum cap and septa that is commonly used for animal
vaccines and other medicaments. This is not intended to be limiting
and other types of packages are included in any and all embodiments
disclosed elsewhere herein.
[0555] As shown in FIG. 23, light member 120 is integrated into the
septum cap of package 110 having label 130 comprising a medicament
(not shown). It may be in the form of a ring that partially
(not-shown in the Figure) or completely (as shown in the Figure)
outlines the mouth of package 110. In such an embodiment, the
outline around the mouth of the package does not interfere with
access to the contents of the package. Additionally, the light
member may be permanently affixed to the serum cap or it may be
added by the end-user. The light member would not interfere with
the needle in accessing the contents of the package. Such a light
member may be in the form of an outline of the septum cap thereby
providing a non-illuminated target for the syringe needle as shown.
In another aspect, the septa of the serum cap itself would be
fluorescent (not shown in the Figure), thereby providing an
illuminated target for the syringe needle.
[0556] In still yet another aspect, the light member is in the form
of a fluorescent paint that is painted onto the package. As one
non-limiting example, the fluorescent paint encircles the septa of
the serum cap in the same manner as illustrated in FIG. 23. The
paint would be applied by the manufacturer at the point of origin
or prior to delivery to the end-user and be permanently affixed to
the serum cap.
[0557] In all aspects, the light member would preferably not
interfere with or affect the medicament inside the package during
access by a syringe needle. In some aspects, the package would be
suitable for use with an animal vaccination gun, and the light
member would not interfere with loading the package into the
vaccination gun. The light member may use any source of lighting as
disclosed herein.
[0558] As shown in FIG. 24, the package 110 comprises the light
member 140 that is completely integrated into the label of the
package. Different parts of the label may comprise the light
member, and the example shown here is only illustrative, not
limiting. In some embodiments, the light member comprises only part
of the label. In some embodiments, the light member comprises the
entire label. In this example, the fluorescence does not interfere
with the contents of the label leaving it clearly legible to the
end-user as required under regulatory guidelines. In all aspects,
the light member would not interfere with or affect the medicament
inside the package during access by a syringe needle. In some
aspects, the package would be suitable for use with an animal
vaccination gun, and the light member would not interfere with
loading the package into the vaccination gun. The light member may
use any source of lighting as disclosed herein.
[0559] As shown in FIG. 25, the package 110 comprises the light
member 170 that is integrated into the external packaging of a two
part medicament. Some medicaments, including animal vaccines, are
commercially available as a lyophilized solid that must be
reconstituted prior to administration to the animal. Different
parts of the label on the packaging comprising both components of
the medicament may comprise the light member, and the example shown
here is only illustrative, not limiting. In this example, the
fluorescence does not interfere with the contents of the label
leaving it clearly legible to the end-user as required under
regulatory guidelines. In all aspects, the light member would not
interfere with or affect the medicament inside the package during
access by a syringe needle. In some aspects, the package would be
suitable for use with an animal vaccination gun, and the light
member would not interfere with loading the package into the
vaccination gun. The light member may use any source of lighting as
disclosed herein.
[0560] As shown in FIGS. 26 and 27, the light member 120 is in the
form of a sleeve that is placed around the package 110 comprising a
medicament. The sleeve may be placed around the package before or
after actuation of the light member. Additionally, the sleeve may
be in place prior to delivery to the end user, or it may be put in
place by the end user. In FIG. 26, the sleeve is mostly transparent
except for the fluorescent outline provided by the sleeve and the
label 130 is visible through the sleeve. Label information may or
may not be provided on the sleeve thereby improving identification
and brand recognition under poor light conditions. Such a
configuration would be useful under circumstances where two or more
different medicaments must be administered at the same time. In
FIG. 27, the entire sleeve surrounding the package 110 comprises
the light member 120 and is fluorescent thereby improving
visibility under poor light conditions. In all aspects, the light
member would not interfere with or affect the medicament inside the
package during access by a syringe needle. With this embodiment,
the label 130 would not be visible through the sleeve. In some
aspects, the package would be suitable for use with an animal
vaccination gun, and the light member would not interfere with
loading the package into the vaccination gun. The light member may
use any source of lighting as disclosed herein.
[0561] As shown in FIG. 28, the light member 120 is in the form of
a structure that is attached to the serum cap of the package 110
comprising a medicament. In such an embodiment, the outline around
the mouth of the package does not interfere with access to the
contents of the package or view of the label 130. Additionally, the
light member may be permanently affixed to the serum cap or it may
be added by the end-user. The light member would not interfere with
the needle in accessing the contents of the package. Such a light
member may be in the form of an outline of the septum cap thereby
providing a non-illuminated target for the syringe needle similar
to that illustrated in FIG. 23. Additionally, the part of the light
member not encompassing the serum cap may or may not be attached to
the side of the package. In some embodiments, the light member is
completely attached to the package, while in other aspects, only
the part of the light member surrounding the serum cap is attached.
In all aspects, the light member would not interfere with or affect
the medicament inside the package during access by a syringe
needle. In some aspects, the package would be suitable for use with
an animal vaccination gun, and the light member would not interfere
with loading the package into the vaccination gun. The light member
may use any source of lighting as disclosed herein.
[0562] As shown in FIGS. 29 and 30, the light member 120 is in the
form of a structure attached to the side (FIG. 30) or the bottom
(FIG. 29) of the package 110. The light member may be attached to
the package prior to delivery to the end-user or it may be attached
by the end-user after delivery. In either aspect, the light member
does not impede the label 130. A side view of the fluorescent
member in FIG. 30 is also shown. In all aspects, the light member
would not interfere with or affect the medicament inside the
package during access by a syringe needle. In some aspects, the
package would be suitable for use with an animal vaccination gun,
and the light member would not interfere with loading the package
into the vaccination gun. The light member may use any source of
lighting as disclosed herein.
[0563] As shown in FIG. 31, the light member 120 comprises a sleeve
or ring around the opening of the package 110. Such a ring can be
put in place prior to delivery to the end user or by the end-user
after delivery. This ring would provide improved illumination of
the septum cap of the package thereby reducing the likelihood of
sticking a syringe needle in the wrong location (e.g., the hand of
the end-user holding the package). In all aspects, the light member
would not interfere with or affect the medicament inside the
package during access by a syringe needle. In some aspects, the
package would be suitable for use with an animal vaccination gun,
and the light member would not interfere with loading the package
into the vaccination gun. The light member may use any source of
lighting as disclosed herein.
[0564] As shown in FIG. 32, the light member 120 comprises a sleeve
that contains an additional opening 180 along the surface of the
light member so that the end-user may more clearly observe the
contents of the package 110. For example, the end-user may observe
the amount of the medicament remaining inside the package. The
light member may include a plurality of additional openings placed
in any location on the light member. Additionally, as shown in this
embodiment, the light member uses LED lighting and includes an
on/off switch 190 for actuation on the side of the light member. In
all aspects, the light member would not interfere with or affect
the medicament inside the package during access by a syringe
needle. In some aspects, the package would be suitable for use with
an animal vaccination gun, and the light member would not interfere
with loading the package into the vaccination gun. The light member
may use any source of lighting as disclosed herein.
[0565] As shown in FIGS. 33 and 34, the light member 120 comprises
an LED light source 150. In such an embodiment, the LED has at
least an on/off switch (not shown) that can be activated by the
end-user. In FIG. 33, the light member 120 is attached to the serum
cap of the package 110 thereby providing an improved visual
identification for the septa. In FIG. 34, the light member 120 is
in the form of a band attached to the package 110 thereby providing
improved visual identification in low light conditions. In this
example, the light member is in the form of a band that fits around
the bottom of a package. In another aspect, the light member is in
the form of a tray or holder 160 where a two part medicament is
placed. In all aspects, the light member would not interfere with
or affect the medicament inside the package during access by a
syringe needle. In some aspects, the package would be suitable for
use with an animal vaccination gun, and the light member would not
interfere with loading the package into the vaccination gun. The
light member may use any source of lighting as disclosed
herein.
[0566] This written description uses examples to disclose the
disclosure, including the best mode, and also to enable any person
skilled in the art to practice the disclosure, including making and
using any devices or systems and performing any incorporated
methods. The patentable scope of the disclosure is defined by the
claims, and may include other examples that occur to those skilled
in the art. Such other examples are intended to be within the scope
of the claims if they have structural elements that do not differ
from the literal language of the claims, or if they include
equivalent structural elements with insubstantial differences from
the literal languages of the claims.
[0567] Further aspects of the present invention are:
1. A package comprising: a medicament, and a light member, wherein
the light member is located on the exterior of the package, and
wherein the light member is configured to provide information to an
end user through the emission of light. 2. The package according to
aspect 1, wherein the information provided to the end user is
related to the viability of the medicament, the location of the
package, the location of a specific part of the package, or any
combination thereof. 3. The package according to aspect 1, wherein
the medicament is a veterinary product selected from the group
consisting of antibiotics, vaccines, nutritional supplements,
growth supplements, antifungal medication, antiparasitic
medication, hormones and combinations thereof. 4. The package
according to aspect 1, wherein the medicament is a vaccine for
bovine viral diarrhea. 5. The package according to aspect 1,
wherein the light member is configured to emit light for a
predetermined period of time. 6. The package according to aspect 1,
wherein light emission is produced by fluorescence,
chemiluminescence, or a light emitting diode. 7. The package
according to aspect 1, wherein the light member uses passive
illumination, active illumination or a combination thereof. 8. The
package according to aspect 1, wherein the light member is part of
the exterior adornment of the package. 9. The package according to
aspect 9, wherein the light member is attached to the exterior of
the package by the end-user. 10. The package according to aspect 1,
wherein the light member comprises part of the label of the
package. 11. The package according to aspect 1, wherein the light
member partially or completely surrounds a mouth or a cap of the
package. 12. The package according to aspect 1, wherein the light
member is activated by the combination of two or more chemicals.
13. A method for determining the viability of a medicament in a
package, said method comprising: activating a light member on the
package comprising said medicament when the package is opened; and
observing the fluorescence in the light member. 14. The method
according to aspect 13, wherein activating the light member
comprises causing two or more precursor chemicals to mix. 15. The
method according to aspect 13, wherein activating the light member
comprises exposing the light member to light for at least a set
time period. 16. The method according to aspect 13, wherein the
medicament is a veterinary product selected from the group
consisting of antibiotics, vaccines, nutritional supplements,
growth supplements, antifungal medication, antiparasitic
medication, hormones and combinations thereof. 17. The method
according to aspect 13, wherein the medicament is a vaccine for
bovine viral diarrhea. 18. The method according to aspect 13,
wherein the light member fluoresces for a period of time equal to
the length of time for which the medicament remains viable. 19. A
method for determining the viability of a medicament in a package,
the method comprising: opening the package and activating a light
member located on the package containing the medicament such that
the light member emits fluorescent light; and observing a change in
color in the light member over a period of time. 20. The method
according to aspect 19, wherein the color changes occurs at a time
when the medicament become non-viable.
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