Note: Descriptions are shown in the official language in which they were submitted.
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Apparatus for the dispensing of liquids, container cartridge suitable for
this, and
system comprising the apparatus for the dispensing of liquids and the
container
cartridge
The present invention relates to a propellant-gas-free apparatus for the
dispensing of
liquids, a container cartridge suitable for this for storing the liquid and
the ensemble
comprising both. In particular the invention comprises
a) a device for the exertion of pressure on a reservoir (container cartridge),
which
has means for accommodating the reservoir and
b) the reservoir itself, whereby a dispensing facility for liquid, e.g. in the
form of a
nozzle and/or nozzle facility, is integrated into this.
The apparatus according to the invention can be used e.g. as a needleless
injector or
as an atomizer. As an atomizer it serves to provide an aerosol of droplets for
inhalative
intake through the mouth and throat area into the lung of a patient or for
nasal intake.
The atomizer according to the invention can also be used for eye treatment
with the
help of a supplementary adapter.
Within the framework of the present description of the invention, the term
apparatus is
equated with the terms device, needleless injector, atomizer or else dosing
inhalation
device. The terms can be used alongside each other as equivalents. Depending
on the
context, either only the device for the exertion of pressure or the ensemble
of same
together with the container cartridge can be meant by these terms. The
difference
between the atomizer according to the invention and the needleless injector
consists in
functional terms mainly in the configuration of the dispensing facility: in
the case of the
needless injector this is so designed that a liquid jet emerges from it which
remains as
such. In the case of the atomizer the dispensing facility is so designed that
either an
aerosol emerges from it and/or at least two liquid jets meeting each other,
which are
atomized into an aerosol by the reciprocal impact. The nebulizer according to
the
invention preferably serves as an inhaler for liquid pharmaceutical active
ingredient
formulations. The latter are preferably propellant-gas-free and the
pharmacologically
active constituents are preferably dissolved or suspended in water, in water-
ethanol
mixtures or in other pharmacologically compatible, non-volatile liquids. The
formulations
are preferably solutions based on water and/or water-ethanol.
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Such formulations lead in the case of inhalative application to an optimal
active
ingredient distribution of the active substances in the lung when they are
converted, by
mean of inhalers suitable for this, into lung-accessible aerosols.
State of the art
The international patent application WO 91/14468 "Atomizing Device and
Methods" or
also WO 97/12687 disclose a device for the propellant-gas-free administration
of a
dosed quantity of a liquid drug for inhalative application. Reference is
hereby made
expressly to the said references and the technology described there is called
"Respimat technology" within the framework of the present invention. This
term also
includes in particular the technology on which a device according to Figures
6a and 6b
of WO 97/12687 and the associated description is based in principle, in
particular the
technology for the exertion of pressure, the locking clamping means and the
means for
the dispensing of the liquid (nozzle). These inhalers can already atomize
quantities of
less than 100 microlitres of a liquid active ingredient solution in the
therapeutically
necessary dosage with preferably a single stroke into a therapeutically-
inhalatively
suitable aerosol within a few seconds. This consists of particles of an
average size of
less than 20 micrometres. The inhalable portion of the aerosol corresponds to
the
therapeutically effective quantity.
In these nebulizers based on Respimat technology a drug solution is converted
by
means of high pressure of up to 500/600 bar into a lung-accessible aerosol and
sprayed. The solution formulations are stored in a reservoir. From there they
are
conveyed via a riser tube into a pressure chamber and further nebulized via a
nozzle. It
is necessary that the active ingredient formulations used display an adequate
storage
stability and at the same time their state is such that they can be applied
directly if at all
possible without further manipulation according to the medicinal purpose.
Furthermore,
they must not contain constituents which can interact with the inhaler so that
the inhaler
or the pharmaceutical quality of the solution, respectively of the produced
aerosol, could
be damaged.
WO 01/64268 describes a further device of this type: a needleless injector
which
operates with a pressure-exertion means similar to the device of WO 97/12687.
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A further device which is not based on the previously named technology is
described in
EP 0918570. Here an atomizer for nose sprays is disclosed which contains, as
core
elements, a spring-operated piston and a nozzle facility. Between piston and
nozzle a
container can be inserted which has a plunger on the bottom side and is closed
top-side
via a seal. This seal of the container is opened before first use by moving
the nozzle,
integrated in the atomizer, by pushing the nozzle through the seal.
The described devices from the state of the art are intended primarily for
continuous
use, i.e. for a use without lengthy breaks. In the case of a lengthy time
break the part of
the solvent of the liquid active ingredient formulation that is located
outside the reservoir
in only small volumes in the pumping- and/or pressure- and/or spray mechanism
can
evaporate and lead there to a formulation with a concentrated quantity of
active
ingredient or the formulation dries up. In these cases the device must, prior
to re-use,
first be cleaned again by single or multiple activation and spraying of the
active
ingredient formulation into the air.
Description of the invention
The present invention relates to a device which, building on the Respimat
technology,
has the object of providing a discontinuous, i.e. occasional administration of
a liquid
drug formulation with reproducible dosing accuracy.
A further object is to be able in such cases to dispense with cleaning steps
between the
discontinuous applications.
A further object is to provide a nebulizer for the discontinuous
administration of liquid
active ingredient formulations in which a drying-up of liquid in the system
that threatens
the pharmaceutical quality of the formulation or the pharmaceutical quality of
the
application is largely minimized.
A further object is to provide such a device in which the use of preservatives
in active
ingredient formulations can optionally be dispensed with.
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A further object is to provide such a device with which liquid active
ingredient formulations can also be nebulized which under normal conditions
(i.e. under air or oxygen atmosphere) or during non-sterile treatment quickly
suffer
loss of pharmaceutical quality.
Finally it is an object of the present invention to make available a
device for the delivery of a dosed quantity of a liquid drug formulation as a
liquid
jet or as an aerosol of droplets by delivery of a dosed quantity of the drug
under
pressure by dispensing facility which does not display the aforementioned
disadvantages of the known devices.
A further object of the invention is to provide a nebulizer for the
preparation of an inhalable aerosol.
A further object of the invention is to provide a needleless injector for
the preparation of a jet injecting itself in or through the skin of an
animal/human or
a human, animal or vegetable membrane.
A further object of the invention is to provide an atomizer for the
application of an aerosol to the surface of the eye.
A further object of the invention is to provide a device for the
dispensing of pharmaceutical liquids for needleless injection, inhalation,
nebulizing
etc. which satisfies the high hygiene requirements of a medical device.
According to one invention embodiment, there is provided a device
for the delivery of a drug in an aerosol of droplets by delivery of the drug
under
pressure, comprising: a container cartridge having a non-pressurized cylinder
therein, at rest, containing a single-dose of the drug, a piston in the
cylinder, and
an outlet end opposite the inlet end having a dispensing facility and means
for
feeding the drug thereto; an elastic element for the storage of a
predetermined
quantity of energy; a mobile element to which the predetermined quantity of
energy can be fed and which is coupled to the piston such that the energy can
move the piston and expose the single-dose of the drug to a predetermined
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increase in pressure within the cylinder; and means for the respective
introduction
and removal of the container cartridge into and from an accommodation chamber
within the device, wherein the device has a housing lower section, one end of
which defines a bottom-side end of the device, a housing middle section housed
rotatable against the housing lower section and a housing upper section,
designed
at least one of vertically swivellable and eccentrically rotatable relative to
the
housing middle section, with the means for accommodating the container
cartridge, such that an end of the housing upper section, in the closed state
of the
device, is not connected to the housing middle section and defines a top-side
end
of the device.
According to another invention embodiment, there is provided a
system for the delivery of a predosed quantity of at least one of a medico-
therapeutically effective substance and a medico-prophylactically effective
substance in an aerosol of droplets by delivery of the predosed quantity of
the
drug under pressure by the dispensing facility, comprising a device as
described
herein.
Detailed description of the invention
Contrary to the known devices which are designed as multi-dose
devices such that as a rule a device contains all the technology provided for
the
dispensing of the liquid and this device is fitted with a drug container which
contains so much drug that up to several hundred single doses can be
administered to the patient, the invention is based on a completely different
inventive concept.
According to the invention a device is provided in which the
technology needed for the dispensing of the liquid is broken down into two
part-
aspects: according to the invention the technology necessary for the
dispensing of
the liquid and the components
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necessary for this is divided into at least two structurally separate parts.
On the one
hand a part (primary packing means) which provides the elements necessary for
supplying the drug and the elements coming into direct contact with the drug.
On the
other hand a second part which contains the elements which provide the energy
and the
mechanics for the dispensing process.
Accordingly, on the one hand a device for the dispensing of a liquid is thus
created, and
on the other hand a reservoir for accommodating the liquid with a dispensing
facility
integrated with it or firmly connected to this container as an integral
constituent. This
container is preferably created as a container cartridge which is fitted into
the device for
the dispensing of the liquid.
The device for the dispensing of the liquid contains
a) means for the respective introduction and removal of the container
cartridge
containing the drug into and from the inside of the device and
b) means for the exertion of pressure on the container cartridge.
Within the framework of the present invention this device is also called
device for
pressure exertion or device.
This device is re-usable, i.e. it is designed for a large number of single
activations and
serves essentially to accommodate the container cartridge together with
dispensing
facility and to dispense the liquid in the container via the dispensing
facility of the
container. For this, the device makes available a mechanism for the exertion
of
pressure on the container or the liquid in its inside.
The container cartridge according to the invention itself contains, in
addition to the
integrated dispensing facility, means which pass the pressure created by the
device
onto the liquid in the inside of the container, in order to feed the thus-
pressurized liquid
to the dispensing facility.
The container is also called reservoir, container cartridge or just cartridge
within the
framework of this description of the invention.
The container cartridge contains the drug and thus serves as primary packing
means.
Additionally, the container contains all the elements which directly come into
contact
with the drug. These include in particular the actual dispensing facility
which is
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preferably a nozzle. The container can for example be developed as a
disposable
container, e.g. as a single-use container.
As already stated, the liquid is preferably a pharmaceutical formulation, e.g.
drug
solutions or drug suspensions.
The objects on which the invention is based are achieved by the provision
according to
the invention of a pressure-creating device and a primary packing means
independent
of this for the drug preparation. Since with every application a new container
cartridge
can be used in the device for the provision of the pressure exertion, this
guarantees for
example that, even if the device is not used over a lengthy period, the drug
formulation
is not impaired as the cartridge remains unused.
The fact that the container cartridges can be such that they accommodate only
a single
dose unit, i.e. only a single application is possible or the quantity and drug
is sufficient
for only a few doses, allows preservative-free drugs to be used. This not only
results in
the patient being burdened with a small quantity of antimicrobially active
substances,
but also makes possible drug formulations of drugs (such as e.g. peptides)
which
cannot be formulated in a stable manner together with preservatives approved
for
inhalation. The freedom from preservatives that can be realized with the
device
according to the invention therefore allows drugs, that were previously unable
to be
formulated because of incompatibility with preservatives, to actually be made
available.
Description of the device for the exertion of pressure
As already described, the re-usable part of the invention builds on the
Respimat
technology. This part comprises a device with a) means for the respective
introduction
and removal of the container cartridge containing the drug into and from the
inside of
the device and b) means for the exertion of pressure on the container
cartridge. This
device builds on the principle as described by WO 97/12687 and its Figure 6.
Preferably this device is similar to a cylinder in form and has a handy size
of less than 9
to 15 cm long and 2 to 4 cm wide, so that the patient can carry it with him at
any time.
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It has a bottom-side end and lying opposite a top-side end. The top-side end
defines the
direction "to the top", the bottom-side end the direction "to the bottom". The
top part has
at its upper end an opening through which the liquid to be dispensed emerges
from the
device.
Preferably the device consists of at least three housing sections, a) a bottom-
side
housing lower section, b) a housing middle section and c) a top-side housing
upper
section.
If the two sections housing middle section and housing upper section form a
structural
unit or differentiation between the two sections is not necessary in the
context, both are
summarized as housing upper section.
The housing upper section open to the top can be sealed by a lid or a cap.
This lid/cap
can be an integral constituent of same or represent an element separate from
it.
The housing upper section is preferably connected rotatable or swivellable
with the
housing middle section.
The housing lower section can be fitted onto the housing middle section in
axial
direction or connected to it.
The housing middle section preferably contains a spring which is tensioned
against the
housing middle section via a rotational movement of the housing lower section.
The housing upper section serves to accommodate the container and contains
corresponding means.
The housing upper section has, parallel to the longitudinal axis of the device
(= vertical
direction) a continuous, preferably tubular, i.e. cylindrical bore. An
optionally cylindrical
cavity is thereby developed which is open on two sides. This cavity is
developed to
accommodate the container cartridge and within the framework of this
description is
also called container accommodation chamber or accommodation chamber in short.
Alternatively it is called housing opening.
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The container cartridge can be pushed into and withdrawn from the
accommodation
chamber manually or via a transport means. The accommodation chamber is
preferably
designed such that the container cartridge is accommodated in a precisely
fitting
manner, i.e. the container cartridge is intended to be able to carry out no or
nearly no
cross-movement in the inside itself. If the container cartridge is for example
a bottle-like
container cartridge, i.e. a container with belly, shoulder and head regions,
the inside of
the accommodation chamber is accordingly developed complementary thereto, i.e.
this
bottle shape is copied as a negative form. In all versions of the invention it
must be
guaranteed that the container is at least briefly firmly connected to the
accommodation
chamber in order that the container, upon exertion of pressure, is not hurled
out of the
accommodation chamber.
The two openings of the accommodation chamber lie opposite each other, one
pointing
towards the bottom of the device and when the device is closed touching the
lid of the
housing middle section. The other opening points towards the top part and
preferably
opens out into a projection, likewise open to the top, straight and tubular,
which is
developed on the top side of the housing upper section and whose vertical axis
is
preferably also developed parallel to the longitudinal axis of the device.
That is to say,
the vertical lying on the opening plane of the tube lies parallel to the
longitudinal axis of
the device. This projection can be a mouthpiece for an inhaler, an adapter for
an eye
bath or the like, or such a device can be connected to the projection. Such an
adapter
for an eye bath is described in PCT/EP0207038, to which reference is hereby
expressly
made. A mouthpiece is described for example in Figures 6 a/b of WO 97/12687,
reference to which is also hereby expressly made in this connection.
Through the top-side opening of the accommodation chamber an aerosol emerging
from the container cartridge can leave the device through the tubular
projection. The
container cartridge preferably fits precisely into the accommodation chamber.
In one version a transport means can be developed in the upper housing section
or
attached to the upper housing section, in particular a carriage or a transport
carriage,
into which the container cartridge is placed and which then transfers the
container
cartridge into its end-position in the accommodation chamber.
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In a further version of the invention it can be provided that a part of the
upper housing
wall is a constituent of a removable grip which is provided with holding means
for
accommodating the container. Through the removal of a part of the housing wall
an
opening forms in this way through which the container can be introduced into
the inside
of the device. This removable part of the housing wall is provided with a
suitable holding
means with which an exact positioning of the container into its target
position is
particularly easily and quickly possible.
In other versions in which the housing middle section and the housing upper
section can
likewise be inseparably connected to each other and thus represent a
structural unit, the
container cartridge can be introduced into the accommodation chamber only from
above, from the latter's top-side end. Also in this case the bottom-side end
of the
container cartridge points towards the bottom-side end of the accommodation
chamber.
The container cartridge can be connected firmly to the accommodation chamber
via a
thread, in order that it cannot be hurled out of the accommodation chamber
during the
exertion of pressure. In this case the container cartridge carries e.g. an
external thread
and the accommodation chamber a complementary internal thread. Such a closure
can
also be developed as a bayonet closure, or corresponding holding means are
developed on the accommodation chamber.
In further versions which contain no such transport means for the container or
in which
the container cartridge can be inserted into the accommodation chamber not
from
above, but only from below, the housing upper section can be connected at
least
partially releasable to the housing middle section. In such a case the two
sections are at
any rate connected to each other such that the housing upper section can be
removed
from the housing middle section such that the bottom-side opening of the
accommodation chamber is accessible. At the same time the device includes
closure
means which ensure that this opening mechanism can only be carried out
deliberately
by the user of the device and a chance separation of the housing upper section
from the
housing middle section during the use of the device is not possible.
In such a version it can be provided that, for the introduction of the
container, the
housing upper section is swivelled eccentrically rotatable or swivellable
about the
housing middle section. Through the swivellable design with the help of e.g. a
hinge or
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swivel joint the whole device opens and the inside of the device becomes
accessible. In
this state the container cartridge can be introduced into the bottom-side
opening of the
accommodation chamber in the inside of the device. The advantage of this
version is
that the hinge or the swivel joint well illustrates the mode of operation of
the mechanism
and the opening is thus self-explanatory. Because of the clear operating
zones, a
single-dose container located in the accommodation chamber immediately becomes
visible after the opening and the manner in which the container cartridge has
to be
replaced is clear.
In all these cases with a housing upper section mobile vis-a-vis the housing
middle
section, the bottom-side opening of the accommodation chamber for the
container can
lie in the bearing surface of housing upper section and housing middle section
or touch
or almost touch the housing middle section.
The opening mechanism can be such that the housing upper section is connected
on
the outside via an eccentric swivel joint to the housing middle section. A
rotary
movement of the housing upper section in the cross-plane defined by the
longitudinal
axis of the device thereby becomes possible, i.e. a horizontal rotary movement
in which
the axis between the bottom-side end of the housing upper section and its top-
side end
always remains aligned parallel or roughly parallel to the longitudinal axis
of the device.
It can also be provided that the housing upper section is developed as a
swivelling flap.
In such a case, the housing upper section can be swivelled away from the
housing
middle section, i.e. the axis between the bottom-side end of the housing upper
sections
is moved as if it were turned upside down. The swivelling flap comprises e.g.
a hinge
which is preferably arranged at the lower end of the housing upper section
In versions in which the housing upper section must firstly be opened before
the
container cartridge can be inserted, it is advantageous if the housing upper
part cannot
be separated completely from the housing middle section. This facilitates the
operability
of the device.
The cavity of the accommodation chamber is such in such versions that therein
the
container can be pushed only from below into the accommodation chamber. In
this
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case the head region of the container cartridge is aligned in the direction of
the top-side
opening and the base region of the container cartridge points in the direction
of the
housing lower section. In the head region of the container lies the dispensing
facility -
which optionally represents an atomization facility, in the ideal case a
nozzle. This can
still lie inside the container accommodation chamber, end in the accommodation
chamber or project through the top-side opening. The analogous case applies to
the
bottom-side end of the container cartridge. The bottom of the container
cartridge
preferably ends plane with the bottom-side opening of the accommodation
chamber.
The accommodation chamber and the container are preferably designed such that
the
container can be pushed into the accommodation chamber only from below but not
from
above. Optionally developed on the container and/or the accommodation chamber
are
further means which prevent the container from being able to be pushed fully
through
the accommodation chamber. These means can consist of guide rails, guide
grooves
or guide indentations along the vertical axis of the chamber, of stops and the
like. The
container then has means contrary thereto. By way of example, the bottom-side
opening of the accommodation chamber can e.g. in the initial area have one or
more
recesses and the container has, bottom-side, corresponding projections which
fit into
the recesses. Also, at the bottom-side opening of the accommodation chamber
e.g. a
recess in the form of a peripheral ring (collar) can be developed. In
longitudinal section
the cavity of the accommodation chamber is thus T-shaped. The container can
then be
developed precisely complementary thereto, i.e. likewise T-shaped in
longitudinal
section, the,,T-beam" forming the bottom of the container. In this case the
container can
have, bottom-side, a ring or collar which thickens the outer casing so that it
fits into the
area of the recess, but no longer into the area with the smaller diameter of
the
accommodation chamber.
In other versions the container and the accommodation chamber taper to the
upper end.
Also, at the top-side end of the accommodation chamber, a stop can be
developed
which ensures that e.g. the container cannot be pushed fully through this
opening. The
stop, e.g. in the form of a tapering opening or a peripheral edge developed to
the inside,
can be developed so that the top end of the container or, in the case of a
bottle-shaped
container, its shoulder strikes against the stop. Since, according to the
invention, the
dispensing facility preferably forms the top end of the container cartridge,
i.e. in the case
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of a bottle-like container cartridge the neck of the bottle, such a stop can
lead to the
dispensing facility being held by the stop or else the container cartridge is
held
underneath the dispensing facility in the shoulder area and the dispensing
facility itself
projects through the opening into the tubular projection.
Preferred are versions in which the container can be pushed fully into the
delivery
chamber only from below. With versions in which the container can be pushed at
least
to a small extent into the accommodation chamber coming from the top opening,
locking
elements are developed on the container and/or the accommodation chamber which
prevent the container from being fully pushed in. It must be borne in mind
that the
container cannot be pushed so far into the opening that pressure can be
transmitted
from the pressure exertion device to the container.
A preferred version has, for the housing upper section as further component, a
swivellable and arrestable protective cap which covers at least the tubular
projection
and thus the top-side opening of the accommodation chamber or the upper lid
area. It is
thus guaranteed that the areas of the device that lie further within are
protected. This is
important in particular if the device is kept in the trouser pocket or a
handbag. In order
that the protective cap itself does not unintentionally leave its arrested
position, it can
provided that the protective cap has a tongue-shaped section which can be
locked in a
tongue-shaped recess of the housing. This protective cap can be developed so
that in
the closed state it covers the release button of the device which is developed
in the
housing middle section, and thereby prevents an unintentional release.
The housing middle section accommodates an energy storage means for the
generation
of pressure on the container and a mobile element which is moved by the
release of the
stored energy and thereby directly or indirectly exerts pressure on the
container
cartridge or on the liquid located in its inside.
The energy storage means is preferably an elastic element, for example a
compression
spring (compression spring). However, the pressure can also be exerted by
means of
other elements for example a motor.
In the case of a compression spring or coil spring as energy storage means
this can be
arranged in a compression spring housing which is located at least partly in
the housing
middle section and optionally is connected to this via snap closures.
Preferably, at least
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a part of the compression spring housing projects bottom-side from out of the
housing
middle section, i.e. the compression spring housing is longer than the housing
middle
section. In this case the compression spring housing or a part of it can be
housed
rotatable by means of a swivel joint in order to tension the compression
spring via a
rotary movement and a locking clamping means. The compression spring can then
be
relaxed again by a release mechanism.
The mobile element can be a piston (pressure piston) which is moved by the
compression spring movement itself. It is pushed into the accommodation
chamber by
the relaxing of the compression spring and exerts pressure on the container.
The pressure piston can be connected to the compression spring via a drive
flange, in
this case being firmly connected to the drive flange. The pressure piston is
preferably
guided over a bore in the otherwise closed lid area of the housing middle
section.
Optionally, the top-side part of the pressure piston can be guided in a
cylindrical
element ( guide cylinder) which is developed in the lid area of the housing
middle
section. In the tensioned state of the compression spring the pressure piston
is wholly in
the housing middle section. In the relaxed state the upper end of the pressure
piston is
located in the housing upper section and pierces a container cartridge
situated there.
The pressure piston has a vertical movement play of up to some centimetres,
preferably
less than 2 cm, particularly preferably between 0.1 and 1.5 cm.
The pressure piston can be developed as a hollow or solid piston and after
activation
exerts high mechanical pressure on the container.
The locking clamping means contain the said compression spring, preferably a
cylindrical helical compression spring, as storage means for the mechanical
energy.
The locking clamping means preferably have a vertical longitudinal axis. In
the following
a version of the locking clamping means is described. The compression spring
acts on a
drive flange as spring piece , the movement of which is determined by the
position of a
locking member. The path of the drive flange is precisely limited by an upper
and a
lower stop. The compression spring is preferably tensioned via a force-
transmitting gear
system, e.g. a screw sliding gear system, by an external torque which is
produced upon
the rotation of the housing middle section against the compression spring
housing in the
housing lower section. In this case the housing middle section and the drive
flange
contain a V-gear system which is single- or multi-gear.
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The drive flange is pressed against the force of the compression spring into
the
compression spring housing.
The compression spring can be kept in the tensioned state via a locking
member.
This locking member has meshing locking surfaces and is arranged in the form
of a ring
round the drive flange. It consists e.g. of a ring made of plastic material or
metal. The
ring is arranged in a plane perpendicular to the atomizer axis and is housed
mobile in
this plane. After the tensioning of the compression spring the locking
surfaces of the
locking member move into the path of the drive flange and prevent the relaxing
of the
compression spring. The locking member is released by means of a key (release
key),
which is likewise developed at the housing middle section. This release
process can be
effected by pressing the key. The release key is connected or coupled to the
locking
member. For the release, the release key is moved parallel to the ring plane,
preferably
into the atomizer; in the process the ring will move in the ring plane. Design
details of
the locking clamping means are described in WO 97/20590, as regards the
locking
mechanism reference is made to Figure 3 following this patent application.
Alternatively
to this the ring can be radially elastically deformable. In this case the ring
is deformed
when the release key is moved for the release. A movement of the ring in the
ring plane
is not necessary.
At the housing upper section and/or housing middle section means can be
developed
which connect the two sections to each other so that a separation, swivelling
open etc.
of the two sections during the pressure release is not possible.
In such cases the housing middle section is connected to the housing upper
section via
a closure which prevents the housing upper section from unintentionally
opening.
To this end the housing middle section can have means of blocking (blocking
means)
the release mechanism which prevent the exertion of pressure being released
when the
device is open, i.e. as long as the housing upper section is not firmly
connected to the
housing middle section.
The housing middle section can also have means which prevent the device from
being
opened (the housing upper section from being opened) as long as the
compression
CA 02497680 2005-03-03
spring is relaxed, and the piston thus projects into the housing upper section
(closure
arrest means).
A preferred version has both blocking means and closure arrest means.
Preferably the blocking means are such that they prevent the movement of the
locking
member (see locking clamping means) in the direction into which the locking
member is
forced in order to relax the compression spring. Such a means can be a spring-
loaded
locking bolt which, seen from horizontal plane from the push button, lies
vertically
behind the locking member. In the opened state of an e.g. tiltable housing
upper section
a spring forces the locking bolt somewhat upwards out of the housing middle
part. In the
closed state the housing upper section forces the locking bolt against the
spring back
into the starting position. The locking bolt can be cylindrical, square and
the like and is
either so configured or so guided that the locking bolt prevents the
horizontal movement
of the locking member that is necessary for the release when the device is
open and
releases the locking member when the device is closed. For example, the
locking bolt
can have recesses which, only in the closed state of the device, free the path
of the
locking member for the relaxation of the compression spring.
The locking bolt can, in alternative versions, also arrest the release key so
that this can
be pressed in only when the device is closed. In such a version, the locking
bolt can
again have recesses. Also in this case the locking bolt prevents a movement of
the
release key until the locking bolt is pressed and thereby frees the path for
the release
key.
Analogous blocking means can be developed for versions of the device in which
the
housing upper section is housed eccentrically rotatable vis-A-vis the housing
middle
section.
In these cases the locking bolt is pressed via the torque back into its
starting position,
and thus frees the path for the locking member or the release key.
The closure arrest means are preferably coupled with the closure between the
housing
upper section and housing middle section. It prevents the housing upper
section from
being opened as long as the pressure piston projects into the housing upper
section, i.e.
CA 02497680 2005-03-03
16
the compression spring is relaxed. It then controls the release of the closure
key which
maintains the closure between the two housing sections (closure key).
The closure key is then coupled with an arrester bolt. The latter is
mechanically
connected to the pressure piston. For example, it can be housed horizontal or
at least
skewed to the longitudinal axis of the pressure piston. If the compression
spring is
tensioned, the pressure piston is located inside the housing middle part. The
arrester
bolt can then be pushed, by a spring, above the pressure piston into its guide
channel.
In this position the closure key is released so that the closure mechanism
between
housing middle section and housing upper section can be opened.
In alternative versions, the arrester bolt does not shift into the guide
channel of the
pressure piston, but along a recess of the pressure piston. The recesses on
the
pressure piston free the path for the arrester bolt only in the tensioned
state of the
compression spring. In the relaxed state of the compression spring on the
other hand,
the arrester bolt blocks the pressure piston so that the release movement of
the arrester
bolt is thus prevented as long as the pressure piston is not wholly sunk into
the housing
middle section.
If the device is relaxed, the pressure piston moves from the bottom to the top
and in the
process pushes the arrester bolt back into its starting position in which it
blocks the
closure key. For this purpose, the tip of the pressure piston or the recess
can have
diagonals and the arrester bolt has the corresponding complementary diagonals.
The housing lower section is located underneath the housing middle section. In
preferred versions it is pushed axially over the compression spring housing
until the
housing lower section and the housing middle section touch, while the
compression
spring housing is located inside the space thereby formed.
The housing lower section is connected to the compression spring housing via a
releasable connection, e.g. a plug-and-socket connection or unreleasable
connection.
Upon operation of the device the housing middle section is rotated against the
housing
lower section, the housing lower section taking the compression spring housing
with it.
The compression spring is compressed via the screw sliding gear system and
CA 02497680 2005-03-03
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tensioned, and the locking means automatically engage. The angle of rotation
is
preferably a whole fraction of 360 degrees, e.g. 180 degrees. Simultaneously
with the
tensioning of the compression spring the drive part in the housing middle
section is
moved a predetermined distance and the pressure piston guided by the cylinder
in the
lid area of the housing middle section is drawn back. Further design details
are
disclosed in the PCT applications WO 97/12683 and WO 97/20590, to the contents
of
which reference is hereby made.
Description of the container cartridge
The container cartridge is a dimensionally stable container which cannot be
deformed
by manual pressure, i.e. it is plastically deformable along neither the
longitudinal axis
nor its transverse axis. Preferably the piston is conceived such that it is
dimensionally
stable vis-a-vis a pressure difference from inside to outside of 49 to 599
bar, preferably
149 to 299 bar.
As already stated, the container or the single-dose cartridge is firmly
connected as a
disposable part to a facility for the dispensing of a liquid, for example a
nozzle. That is to
say, this facility is an integral constituent of the container. Thus the
device for the
exertion of pressure (the device) no longer needs its own dispensing facility,
so that this
device for the exertion of pressure as such is structurally simplified vis-a-
vis the devices
of the Respimat mark known from the state of the art.
The container cartridge is preferably of cylinder-like or bottle-like design.
The container
can also be designed in cartridge form or in imitation of the shape of an
inhalation
capsule. The outer shape of the container need not be a faithful copy of a
cylinder, a
bottle, cartridge or inhalation capsule, but preferred versions resemble one
of the
objects. The shape of an inhalation capsule can be seen in the figures of EP
1100474,
reference to which is hereby made. Such capsules can be described as cylinder-
like
structures with two semicircular ends. The container cartridge has a bottom-
side and a
top-side end, the bottom-side end pointing towards the bottom-side end of the
device for
the exertion of pressure when the container is fitted into this device.
Correspondingly,
the top-side end of the container cartridge points towards the top-side end of
the device
for the exertion of pressure.
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In a preferred version, the container cartridge has a rotation-symmetrical
outer contour
which tapers from the bottom to the top. The diameter preferably tapers in
steps. Most
preferably, at least one such step is developed such that the container has a
shoulder.
Such a container can e.g. be of bottle-like design with foot part, belly part,
shoulder and
top part. The foot region preferably has a collar running in peripheral manner
around the
casing or is broadened in the bottom region. This can be achieved using a
corresponding baseplate. The advantage of this shape is that the container can
be
pushed in correct orientation only and only from the bottom opening [into] the
accommodation chamber into which the container fits precisely.
In alternative versions, the cross-section of the container vertical to the
longitudinal axis
is triangular, square or polygonal or has another non-rotation-symmetrical
shape. The
advantage of these shapes is that the container must be very deliberately
pushed into
the accommodation chamber by the user, so that errors are avoided. In such a
version,
the cross-section can e.g. have the shape of a circle sector, i.e. a structure
with three
corners, two straight lines and a curved side. The angle between the two
straight sides
can have any values between greater than 0 degrees and less than 360 degrees,
values of 200 degrees to 300 degrees are preferred. Alternatively, the cross-
section can
be in the shape of a circle segment, i.e. a structure which has one straight
line and an
arc spanning the straight line, or a circle in which a piece is cut off
parallel to the
diameter. The height above the mid-vertical of the straight line can be
greater than the
radius of the circle on which it is based, the same size or smaller. The
height is
preferably greater than the radius. A tapering from the bottom to the top,
optionally step-
like, is also advantageous with these versions.
In other alternative versions, with the previously described containers, the
baseplate of
the container, which is broader compared with the rest of the container,
itself has a
circular cross-section.
In further versions, the cross-section of the container is round, whereas the
baseplate
(foot) of the container, which is broader compared with the rest of the
container, has the
previously described non-rotation-symmetrical cross-section.
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The container cartridge is preferably a single-dose container or a single-dose
cartridge.
This container has a hollow cylinder to accommodate the fluid (stock
cylinder), the
actual stock chamber, which also functions as a pressure chamber during use.
There
can be located bottom-side in the stock cylinder a movably arranged element
(movable
container punch, e.g. in the form of a piston (container piston) or preferably
a ball
(container ball)), which seals off the fluid to the outside. The facility for
the dispensing of
the liquid is arranged at the top-side end of the container. The movably
arranged
container punch, the stock chamber and the dispensing facility are arranged in
series so
that a liquid which is located in the stock cylinder, i.e. in the stock
chamber, is pressed
through the dispensing facility when the container punch is pushed into the
stock
chamber by a force acting from outside. During use with the device for the
exertion of
pressure, the force acting from outside is the force which is exerted by the
pressure
piston on the container punch. In the case of a drug solution or suspension as
stored
liquid, this is fed to the atomization facility. This is preferably an
atomizer nozzle which
for its part leads to the nebulizing of the drug.
Optionally the bottom-side opening and the top-side opening of the stock
cylinder can
have a sealing means or several sealing means.
The sealing means of the bottom-side opening can be arranged either bottom-
side of
the container punch or in top-side direction. Preferably the container punch
itself seals
off the bottom-side opening. Optionally a sealing film is applied bottom-side
to the
bottom-side opening.
The sealing means of the top-side end can likewise be arranged in bottom-side
direction, i.e. before the dispensing facility or after it, thus top-side.
Preferably it is
arranged top-side, i.e. the opening or the openings of the dispensing facility
is (are)
sealed, e.g. by a manually detachable sealing film.
Preferably it is provided that the stock cylinder inside the container has a
supply stock
capacity of at most 1 ml, capacities of at most 100 microlitres being
preferred, e.g. for
eye treatment, and capacities of less than 50 microlitres particularly
preferred. For nasal
application, capacities of up to 30 microlitres can be preferred and for
pulmono-
inhalative application capacities of up to 15 - 20 microlitres are most
strongly preferred.
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This quantity of drug is sufficient for the administration of a single dose
and avoids the
use of a preservative, as desired.
In a preferred version the stock cylinder has a constant internal diameter
over the whole
longitudinal axis. The bottom-side and top-side openings are perpendicular to
the
longitudinal axis on the upper side or lower side of the stock cylinder. Both
openings
extend over the whole diameter of the stock cylinder.
The container preferably has a height of up to 4 cm, more preferably up to 2.5
cm,
particularly preferably up to 2 cm. The stock cylinder has a corresponding
length in its
inside, with a corresponding ratio of length to cross-section, in order to
provide the
whole filling capacity. The diameter of the cross-section is preferably up to
5 mm, more
preferably up to 3 mm and particularly preferably up to 2.5 mm.
The container punch lies with a precise fit in the stock cylinder and is
preferably made
from a plastic material. This can be for example: polytetrafluoroethylene,
ethylene-
propylene-dienepolymer, silicon, elastomers, thermoplastic elastomers, such as
Santoprene and others.
Preferably the container punch lies exclusively inside the stock cylinder and
more
preferably the bottom-side end of the container piston ends bottom-side in the
container, i.e. the container punch does not project outwardly beyond the
bottom of the
container and therefore also cannot be accidentally moved during storage,
transport
and the like.
The container punch is dimensioned for a precise fit or approximately precise
fit, so that
it closes the stock cylinder tight on the one hand, but on the other hand can
be moved
into the stock cylinder when a force is exerted.
By precise fit or approximately precise fit is meant that the container punch
occupies the
stock cylinder according to the cross-section, optionally the diameter of the
container
piston that is responsible as regards the closure of the stock cylinder can be
up to 5%
wider than the diameter of the stock cylinder. By approximately precise fit is
meant that
this diameter of the container punch is slightly smaller than the diameter of
the stock
cylinder.
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Preferably the container punch is developed as a container punch with precise
fit. Such
a variant can be of advantage when filling the stock cylinder, but also when
guiding the
container stamp through the stock cylinder.
The container punch can have a slightly greater external diameter than the
internal
diameter of the stock cylinder, especially when it is situated in the closure
position
inside the stock cylinder. A better closure of the bottom-side opening is
thereby
achieved. In addition this has the advantage that the container punch
completely
empties the stock cylinder when the container punch is pushed through the
stock
cylinder.
In one version the container punch is a cylinder.
A cylindrical container punch can have a recess in the form of a cavity which
is open to
one side. The opening of the recess points towards the bottom-side opening of
the
stock cylinder, i.e. in the direction of the pressure piston. The internal
diameter of the
opening or of the recess is greater than the external diameter of the pressure
piston of
the device for the exertion of pressure. In cross-section the container piston
then has
the shape of a U optionally with edges developed as corners. The bottom of the
recess
forms the point on the container piston at which the pressure piston can
engage in order
to press the container piston in the stock cylinder. The advantage of this
design and
arrangement is that the container piston can taper slightly, because of the
pressure of
the pressure piston on the bottom of the recess, at the opposite end, that is
on the side
of the container piston which forms spear tips upon penetration of the
reservoir. That is
to say, because of the pressing of the pressure piston, there is a change in
cross-
section in the shape of the container piston from the U-shape into
approximately a V.
A simplified passage of the container piston through the stock cylinder is
thereby
achieved. A further advantage of this change of shape, caused by the pressure
of the
pressure piston, of the container piston is a reduction in the pressure of the
pressure
piston on the walls holding the container piston, so that even a firmly seated
container
piston can be released and moved from the pressure piston without tilting.
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In order to prevent a tilting of the container punch, guide facilities, e.g.
guide rails or
guide vanes etc., can also be developed at the container punch and / or the
side wall of
the stock cylinder.
To improve the sliding of the container punch through the stock cylinder, the
container
punch or the wall of the stock cylinder can be coated with a pharmacologically
compatible lubricant. Such lubricants are known from the state of the art and
include
e.g. sorbitan esters, e.g. sorbitan trioleate, oleic acid, lecithin and other
fatty acids, fatty
alcohols, esters of fatty acids and the like.
In other structurally similar containers, the container punch can be part of
the rigid and
inflexible baseplate of the container. In this case the pressure piston
penetrates the
baseplate of the container and then presses into the stock cylinder. In such
cases
theoretical fracture points can be developed on the baseplate, so that the
pressure
piston can more easily push out the integrated container punch from the
baseplate
during the exertion of pressure.
In these cases the pressure piston can be dimensioned such that no liquid is
forced out
of the reservoir past the pressure piston bottom-side from the container.
In other versions the bottom-side opening of the stock cylinder is closed only
by a
flexible sealing means, e.g. a sealing film and the like. Preferably the
sealing means are
not indestructibly removable from the container. In this case the pressure
piston
assumes the function of the container punch.
The dispensing facility, which can be an atomization facility and which is
integrated with
the container according to the invention, can be a special nozzle, as
described for
example by WO 94/07607, WO 99/16530 or the German patent application with the
application number 10216101.1. Reference is hereby expressly made to all the
documents.
In the simplest case the nozzle is a kind of perforated shutter, i.e. the
nozzle represents
a body with a single central continuous bore.
Another version of the nozzle is a body with at least two or more continuous
bores
which run parallel to each other or are inclined towards each either. In the
case of bores
CA 02497680 2005-03-03
23
inclined towards each other, the side with the acute angle forms the nozzle
outlet side,
the other side accordingly the nozzle inlet side. In the case of at least two
bores the
inclination angle is preferably 20 degrees to 160 degrees, preferably 60 to
150 degrees,
particularly preferably 80 to 100 .
The nozzle openings are preferably arranged at a distance of 10 to 200
micrometres,
more preferably at a distance of 10 to 100 micrometres, particularly
preferably 30 to 70
micrometres. 50 micrometres are most strongly preferred.
The dimensions of the nozzle openings and nozzle channels correspond to those
of the
versions described in the following.
The nozzle can consist e.g. of glass, silicon, plastic material, such as PBT
(polybutadiene terephthalate), PP (polypropylene), PC (polycarbonate) and
others.
Another version of the nozzle is described in EP 0860210. In particular
reference is
hereby expressly made to the drawings of this patent specification. Such a
nozzle
consists of two parts, a base part and a top part, which are laid one above
the other in
order to thereby form the actual nozzle block. These two single parts can have
microstructures which can be obtained e.g. by etching. Preferably the two
parts are
developed as plates and the microstructures form in the inside of the nozzle
block a
liquid connection from one side to the other, namely from the nozzle inlet
side to the
nozzle outlet side. There is at least one round or unround opening on the
nozzle outlet
side. Preferably these openings or, in the case of several, all these
openings, have a
depth of 2 to 10 micrometres and a width of 5 to15 micrometres, the depth
preferably
being 4.5 to 6.5 micrometres and the length 7 to 9 micrometres.
In the case of several nozzle openings, two are preferred, the jet directions
of the
nozzles in the nozzle body can run parallel to each other or they are inclined
towards
each other in the direction of the nozzle opening. In the case of a nozzle
body with at
least two nozzle openings on the outlet side, the jet directions - and this is
preferred -
can be inclined towards each other, in order to atomize the liquid through the
impact.
In this case the inclination angle is preferably 20 degrees to 160 degrees,
preferably 60
to 150 degrees, particularly preferably 80 to 1000.
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The nozzle openings are preferably arranged at a distance of 10 to 200
micrometres,
more preferably at a distance of 10 to 100 micrometres, particularly
preferably 30 to 70
micrometres. 50 micrometres are most strongly preferred.
The jet directions accordingly meet in the area around the nozzle openings.
The two individual parts can be worked from glass, silicon or a plastic
material.
Preferably the microstructures are etched into a silicon plate. Both parts
have at least
one essentially flat surface. When the two parts are laid one above the other,
these two
surfaces lie one on the other.
For the sake of simplicity a version is described in the following in which
only the base
part has relief-like microstructures, but not the top part. In other versions
the situation is
exactly the opposite or both parts have these microstructures.
A set of channels can be developed on the base part on the flat surface, in
order, in
cooperation with the essentially flat surface of the top part, to create a
large number of
filter passageways (filter channels). The base part can also have a plenum
chamber,
the lid of which is again formed by the top part. This plenum chamber can be
located
up- or downstream from the filter channels. Two such plenum chambers can also
be
developed. Another set of channels on the essentially flat surface of the base
part,
which - if present - is located downstream from the filter channels, forms
together with
the top part a set of channels which create a large number of nozzle outlet
passageways.
The overall cross-section surface-area range of the nozzle outlets is
preferably 25 to
500 square micrometres. The overall cross-section surface-area range is
preferably 30
to 200 square micrometres.
In another version this nozzle structure also has only a single nozzle
opening.
In other versions of this type the filter channels and/or the plenum chamber
are missing.
The filter channels are preferably formed by projections which are arranged in
zig-zag
form. Thus for example at least two rows of the projections form such a zig-
zag
configuration. Several rows of projections can also be developed, the
projections are in
each case offset laterally relative to each other, in order to thereby build
up second rows
skewed to these rows, these last-described rows then forming the zig-zag
configuration.
In such versions the inlet and the outlet can each have a longitudinal slot
for unfiltered
or filtered fluid, each of the slits being essentially exactly as wide as the
filter and
essentially exactly as high as the projections on the inlet or outlet sides of
the filter. The
CA 02497680 2005-03-03
cross-section of the passageways formed by the projections can in each case
stand
perpendicular to the direction of flow of the fluids and can - seen in
direction of flow -
decrease from row to row. The projections which are arranged nearer to the
inlet side of
the filter can also be larger than the projections which are arranged nearer
to the outlet
side of the filter. In addition the distance between the base part and the top
part can
reduce in the area from the nozzle inlet side to the nozzle outlet side.
The zig-zag configuration which is formed by the at least two rows of
projections has an
inclination angle alpha of preferably 20 to 250 .
Further details of this nozzle structure can be found in WO-94/07607.
Reference is
hereby made to the contents of this document, in particular to figure 1 and
its
description.
The described nozzles can be connected to the opening of the container via a
nozzle
holder. Such a nozzle holder is in the simplest form a ring or body with an
opening into
which the nozzle can be fitted. This opening covers the nozzle block over its
whole
generated surface, i.e. the surface that stands perpendicular to the
preferably linear axis
which is formed by the nozzle inlet side and the nozzle outlet side. The
holder is open to
the top and bottom, in order to prevent neither the supply of liquid to the
nozzle inlet
side of the nozzle, nor the dispensing of the liquid. This holder can in turn
be fitted into a
second holder. The outer shape of the first holder is preferably conical. The
opening of
the second holder is formed accordingly. The first holder can consist of an
elastomer.
The dispensing facility is connected in form-locking manner to the container
and to this
end is preferably screwed or crimped to the container via a screw cap or
crimping
sleeve with in each case an open side, which is particularly economical.
Alternatively
the form-locking connection can also be achieved by gluing or welding, in
particular by
means of ultrasonic welding.
In each case the connection is such that the nozzle opening lies free and
cannot be
blocked by the closure.
In the case of a needleless injector the nozzle is such that a sharp liquid
jet is produced
thereby. A funnel-shaped shield (hopper) can be developed around the nozzle,
the
narrowing end of which surrounds the nozzle. In this case the nozzle can be
introduced
CA 02497680 2005-03-03
26
via the top-side opening of the accommodation chamber into the latter. The
hopper then
projects from out of the top-side opening of the accommodation chamber.
During use the broad opening of the hopper is placed onto the point on the
skin into
which the liquid is to be injected. A spraying of the liquid is prevented by
this measure.
In other versions this function can be taken over by the tubular projection of
the device
for the exertion of pressure if this is accordingly developed, i.e. the
projection which
forms a mouthpiece in the case of an inhaler.
Through the device according to the invention for the exertion of pressure, a
pressure is
to be created in the container cartridge which presses the drug in the
container with an
entry pressure of up to 600 bar, 50 bar to 600 bar, particularly preferably
200 to 300 bar
on the nozzle body and thus atomizes it via the nozzle openings e.g. into an
inhalable
aerosol. The preferred particle sizes of such an aerosol are then up to 20
micrometres,
preferably 3 to 10 micrometres. In order to be able to build up this pressure,
the
dimensions of the pressure piston width, the length of stroke of the pressure
piston, the
diameter of the container piston, the capacity of the stock cylinder which now
functions
as pressure chamber and the force of the compression spring are chosen in
accordance
with the physical laws.
In addition to the advantages, described at the outset, of the invention,
through the
container according to the invention more highly concentrated nanosuspensions,
i.e.
suspensions in which the suspended particles are ca. 100 - 500 nm in size, can
without
complications be dispensed as a jet or atomized without the single use
resulting
practically in a blockage of the nozzles.
Via the device according to the invention, solutions or suspensions with every
type of
medico-therapeutically and/or medico-prophylactically effective substances are
preferably dispensed. These include not only low-molecular, mostly chemico-
synthetically produced, pharmacologically active substances, but also
proteins,
peptides, other biomacromolecules or vaccines which can be dispensed in such a
device without substantial loss of activity. Reference is made to the contents
of EP
1003478.
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27
According to the invention, several replaceable reservoirs containing the
fluid to be
dispensed can optionally be pushed one after the other into the device for the
exertion
of pressure and used. The reservoir contains the corresponding pharmaceutical
preparations or aerosol preparation. In such cases the device for the exertion
of
pressure can be fitted with a revolver magazine or a similar magazine derived
from the
field of rapid-fire pistols. In addition the device for the exertion of
pressure can then
include means which accordingly allow an automatic loading of the
accommodation
chamber with the reservoir cartridge.
The dispensing process is started by lightly pressing the release key. The
locking
means free the path for the drive part. The tensioned compression spring
pushes the
pressure piston into the stock cylinder of the container. The fluid emerges
from the
nozzle of the container - optionally in atomized form.
As already described, for an inhaler per stroke capacities of 10 to 50
microlitres are
preferably atomized, capacities of 10 to 20 microlitres are particularly
preferred, a
capacity of 15 microlitres is quite particularly preferred.
All the components of the device for the exertion of pressure or of the
container
cartridge are made from a material suited to the function. The housing and -
if the
function allows - also other parts are preferably made from plastic material,
e.g. by
injection moulding. For medical purposes - if necessary - physiologically
harmless
materials are used.
The invention is preferably used as an atomizer of liquid drug preparations.
Description of the figures
The invention will be described in more detail in the following with reference
to
embodiments.
Figure 1 shows a cylinder-symmetrical version of the device according to the
invention.
Figure 2 shows a device including container cartridge.
Figure 3 shows a version with a removable grip for accommodation of the
container
cartridge.
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Figure 4 shows a version with housing middle section 2b and housing lower
section 3
swivellable vis-a-vis the housing upper section 2a.
Figure 5 shows a further version of the device.
Figures 6a and 6b show the opening of the protective cap of the device.
Figure 7 shows a device with swivellable housing upper section 2a and its
loading with
the container cartridge.
Figure 7 schematically describes a version of the device.
Figure 8 schematically describes a further version of the device with
swivellable arm.
Figure 9a schematically describes the process of loading the device with the
container,
the housing upper section 2a being rotated horizontally vis-a-vis the housing
middle
section 2b and housing lower section 3.
Figure 9b schematically describes the process of loading the device with a
swivelling
mechanism with the container.
Figure 10 and Figure 11 describe the pressure-exertion means in the form of a
locking
clamping means.
Figures 12 and 13 show the locking mechanism.
Figures 14a to 14e show the container cartridge according to the invention.
Figure 15 describes a dispensing facility, preferably for the atomization of a
liquid.
Figures 16 and 17 describe the device in cross-section.
Fig. 18a to f show various containers with non-rotation-symmetrical outer
contour
elements.
Fig. 19a and 19b show an example of an accommodation chamber for a rotation-
symmetrical container in which the latter, as appropriate to its function, can
be pushed
into the accommodation chamber only from below.
Figure 1 shows a device 1 according to the invention in a cylinder-symmetrical
version.
It consists of a housing upper section 2a, the housing middle section 2b,
which are also
both together numbered 2 as a structural unit, and housing lower section 3.
The upper
housing section 2 is covered by a protective cap 7. The device 1 has an
opening 4
through which a view into the inside is made possible. There is located at the
centre of
the axis of symmetry 5 a mobile element in the form of a pressure piston 6
above which
in direct manner the container cartridge 10 (cf. Fig. 2) lies. Through
succeeding
movement of the protective cap 7 parallel to the axis of symmetry 5 in the
direction of
the arrow, the device 1 is closed and is ready for use, in which e.g. an
aerosol emerges
CA 02497680 2005-03-03
29
in droplet form from the opening 9. In order to prevent an inadvertent
opening, a locking
mechanism 8a, 8b is provided.
Figure 2 shows a likewise cylindrically designed device 1 in which, after the
removal of
the protective cap 7, the container cartridge 10 is introduced from above into
the inside
of the device 1. To this end, the container cartridge 10 is guided along the
axis of
symmetry 5 in the direction of the pressure piston 6. The container cartridge
10 has on
both sides a groove 11 which is then surrounded by the arms of the holding
means 12.
The nozzle or dispensing facility of the container cartridge is identified as
feature 29. Via
a movable button 13 which is moved by the user in the direction of the arrow,
a
transport carriage 14 is activated which moves the container cartridge 10 in
the direction
of the pressure piston. When the device is used, the compression spring 16, in
cooperation with a clamping element 15 (drive flange), ensures the rapid
movement of
the pressure piston 6 along the axis of symmetry in the direction of the
container
cartridge 10. This has a stock cylinder, not represented in the drawing, into
which the
pressure piston 6 cuts during the release procedure and in the process, by
advancing a
stopper (container piston, not shown) fitted into the container 10, pushes the
drug
solution located in the stock cylinder through the dispensing facility (not
represented in
the drawing) located at the container cartridge 10. The aerosol passes out
from the
dispensing facility, i.e. in this case an atomization facility, via the
mouthpiece 17 to the
outside.
Figure 3 shows a version in which a part of the external wall of the device is
cut out and
forms a grip 18 which is provided with a holding means 12 for accommodating
the
container cartridge 10. The container cartridge 10 centrally has a dispensing
facility 29.
After the grip 18 is fitted with a new container cartridge 10, the grip is
introduced in the
direction of the arrow and is ready for use.
Figure 4 shows a version in which the housing lower section 3 and the housing
middle
section 2b are shown simplified as a unit. The housing upper section 2a can be
swivelled vis-a-vis the housing middle section by means of a hinge 19. To this
end, the
detent 20 is firstly operated in order that the housing middle section 2b
together with the
housing lower section 3 is transferred from its starting position A into its
final position B.
In the swivelled-out position of the housing middle section 2b plus housing
lower section
CA 02497680 2005-03-03
3, the container 10 can be introduced into the housing upper section 2a or
replaced. By
manual pressure on the top end of the container cartridge through the
mouthpiece 17,
the container cartridge can be withdrawn again.
Figure 5 shows a version in which a part of the device 1 can be swivelled out
as a
swivelling flap 21. In the swivelled-out position, a view into the inside of
the device is
possible, and in Figure 5 can be seen a compression spring 16 for moving the
pressure
piston 6 which, in the case of use, acts on the container cartridge 10 which
is fixed in a
target position by a holding means 12. After the device 1 is fitted with the
container
cartridge 10, the swivelling flap 21 is swivelled in the direction of the
arrow to the axis of
symmetry. The release is carried out via the release button 22.
Figures 6a and 6b show the device with closed and opened protective cap 7. The
housing upper section 2a is provided via a hinge 48 with a protective cap 7,
which is
initially swivelled outwards and thus reveals the mouthpiece 17. The
protective cap 7
can lock into the closure position on the housing upper section 2a via the
flap 23. The
protective cap 7 also has a tongue-shaped section 24. This section 24 covers
the
tongue-shaped area 25 in which the release key 35 is located. In the closed
state of the
protective cap 7 the release key 35 cannot therefore be unintentionally
pressed.
The closure key 47 is located at the housing middle section 2b. If this is
activated, the
housing upper section can be swivelled up around the hinge 48 (Figure 7). In
this
position can be seen the arrester bolt 49, connected to the closure key 47,
which
ensures that the housing upper section 2a can be opened only when the
compression
spring 16 is tensioned. In this position the container cartridge 10 can be
pushed into the
accommodation chamber 30 (dashed) (along the dashed marking).
Figure 8 shows a version with a slightly L-shaped housing 26 with a mouthpiece
17
located thereon. A hinged arm 27 allows the mechanical drive unit 28 to be
extended,
and thus the container cartridge 10 to be introduced into or removed from the
dashed-
line accommodation chamber 30. After a suitable fitting of the device 1 with
the
container cartridge 10, the hinged arm 27 is pulled back, so that the device
reaches its
operating position.
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31
Figure 9a shows a variant with a housing upper section 2a housed eccentrically
rotatable. In this case the container 10 can be introduced into the
accommodation
chamber 30 only when the housing upper section 2a is rotated out laterally,
i.e.
horizontally vis-a-vis the housing middle section 2b. In this position the
container 10 can
be introduced into the dashed-line position, and then the additional part
pushed back.
Figure 9b shows in several snapshots from left to right the fitting of a
device with a
mechanism in which the housing upper section 2a can be opened only if it is
first moved
vertically against the housing middle section 2b.
Fig. 10 shows a longitudinal section through a locking clamping means. The
upper
cylindrical housing section 2, which in this case represents exclusively the
housing
middle section 2b, housing upper section 2a is not shown, grips over the
compression
spring housing 31 to which it is connected via snap catches 32. The snap
catches 32
are attached to the outside of the compression spring housing 31 and extend
over two
circle segments lying opposite each other, each of roughly 30 degrees. They
engage in
a peripheral groove on the inside of the upper housing section 2. The housing
lower
section can be inverted over the compression spring housing and is connected
via
connection means (locking means) to the compression spring housing 31
removable but
not rotatable against each other (the connection is not shown). The housing
middle
section 2b or the housing section 2 and the compression spring housing 31 are
rotatable against each other. Through the connection of the compression spring
housing
16 to the housing lower section 3, the two housing sections 2 and 3 and in
particular 2b
and 3 are also rotatable against each other. Located in the compression spring
housing
31 is the compression spring 16, which generally is already pretensioned when
the two
housing sections are put together. The compression spring 16 rests on a
peripheral
projection at the lower end of the compression spring housing 31 and on the
drive
flange 33, which is arranged movable in axis-parallel manner between the upper
housing section 2 and the compression spring housing 31 and for its part
presses
against the upper housing section 2. The pot-shaped drive flange 33, which
carries the
pressure piston 6, projects into the upper housing section 2. The ring-shaped
locking
member 34 encloses the drive flange 33. The release key 35 attached to the
locking
member projects laterally from out of the upper housing section.
CA 02497680 2005-03-03
32
In the case of a screw sliding gear, the collar of the pot-shaped drive flange
33 generally
contains two saw-tooth-shaped recesses, on which two saw teeth in the upper
housing
section glide (not shown). Upon rotation of the upper housing section 2
against the
housing lower section 3 and thus against the compression spring housing 31,
the drive
flange 33 is pressed against the force of the compression spring 16 further
into the
compression spring housing 31. As soon as the upper edge of the drive flange
33 has
been pushed far enough down through the locking member 34, the ring-shaped
locking
member 34 moves perpendicular to the housing axis between the upper edge of
the
drive flange and a ring-shaped projection 34 in the upper housing section 2
and holds
the drive flange 33 and the compression spring 16, additionally tensioned by
the
movement of the drive flange, firmly in the reached position.
The average compression spring force is 10 to 150 N. Between the upper and the
lower
resting position of the drive part, the compression spring force changes by
roughly
10% of the average compression spring force.
By pressing the release key 35 the ring-shaped locking member 34 is pushed
back
perpendicular to the housing axis, as a result of which the path of the drive
flange 33 is
freed. The compression spring 16 pushes the drive flange 33 up for a
predetermined
distance and thus operates the pressure piston 6, connected to the drive
flange 33,
which is guided in the guide cylinder 38.
In Fig. 10 the locking clamping means is shown with the drive flange 33 in its
upper
resting position and with the locking member 34 released. Fig. 11 shows the
locking
clamping means with the drive flange 33 in its upper resting position and with
the
locking member 34 engaged. The stop 36 is the path limit for the drive part 33
in its
lower resting position, the stop 37 is the path limit in its upper resting
position. By
rotating the two housing sections against each other, the position according
to Fig. 10
changes into the position according to Fig. 11. By pressing the release key 35
the
position according to Fig. 11 changes into the position according to Fig. 10.
Figs. 12 and 13 show a cross-section through the locking clamping means in the
middle
of the ring-shaped locking member, Fig. 12 corresponding to the position of
the locking
CA 02497680 2005-03-03
33
clamping means according to Fig. 10 in released position of the locking member
34 and
Fig. 13 corresponding to the position of the locking clamping means according
to Fig. 11
in engaged position of the locking member 34.
Figures 14a to e show the container cartridge 10 according to the invention.
Located
top-side is the dispensing facility 29 which is connected to the outlet of the
stock
cylinder 40 and can conduct a liquid. The bottom-side end of the stock
cylinder 40 is
closed by the container piston 39.
The opening of the dispensing facility 29 is closed by an upper sealing means
58. The
container piston 39 is closed to the outside by the lower sealing means 59.
The
dispensing facility 29 is held by one or more holders 60.
In Figure 14a the holder 60 is connected in form- or material-locking manner
(e.g.
welded or glued) to the container cartridge 10. In Figure 14b it is held by a
crimping
sleeve 61, in Figure 14c by a screw cap 62. In Figure 14e the crimping sleeve
61
surrounds the container from the top area to the bottom. In all the versions
shown the
baseplate 63 is wider than the container belly. The holding means, such as
crimping
sleeve or screw cap, are such that they free the opening of the dispensing
facility 29,
i.e. do not cover this opening.
In all the illustrated versions the container cartridge is pushed bottom-side
into the
housing upper section until the baseplate 63 encounters the edge delimiting
the bottom-
side opening of the accommodation chamber 30.
Figure 15 shows a cross-section through the preferred nozzle structure 41. The
figure
shows the relief-like microstructure of the base part 42. The area 43
represents the non-
etched part of the plate. The figure shows only one nozzle opening 44 instead
of
preferably two channels inclined towards each other with nozzle openings. The
projections forming the zig-zag-configurated filter bear the reference number
45. The
nozzle inlet side bears the reference number 46.
Figure 16 shows a preferred version of the device in cross-section. This
representation
shows the locking clamping means described by Figures 10 and 11 and differs
only
slightly from the device described there, in particular in the design of the
pressure piston
6 and of the drive flange 33. Compared with the version according to Figures 9
and 10
CA 02497680 2005-03-03
34
the device in this version has blocking means which prevent the exertion of
pressure
caused by the pressing of the key 35 from being released as long as the
housing upper
section is open. In this version these blocking means consist of a locking
bolt 50 which
is housed bottom-side against a spring 51. Top-side, the locking bolt touches
the bottom
of the housing upper section 2a. The locking bolt has areas with larger and
smaller
diameters. It is situated behind the locking member 34. In the closed position
of the
device a recess 52 developed at the locking bolt 50 lies behind the locking
member 34
and thereby frees the path for the locking member. In the opened position of
the device
the spring 51 of the locking bolt presses slightly upwards, so that the wider
area 53 of
the locking bolt 50 comes to rest behind the locking member 34 and thus blocks
the
release of the locking member. The release key 35 cannot be pressed in this
position.
In alternative versions, the spring 51 is connected top-side to the locking
bolt and the
mechanism is mirrored accordingly. Figure 16 shows the closed device with
tensioned
compression spring 16, i.e. the top of the pressure piston 6 still lies in the
housing
middle section 2b.
Figure 17 shows another cross-section plane of the version according to Figure
16 with
the spring relaxed. The top of the pressure piston 6 has forced the container
piston 39
into the container cartridge 10 and the liquid has been extracted from the
latter through
the nozzle 29. In this perspective the closure between housing lower section
and
compression spring housing 31 is represented under the reference number 64.
The
closure can be releasable or fixed, it can be achieved via a snap spring and
the like.
The closure arrest mechanism can also be recognized from this perspective. The
closure key 54 is developed at the housing upper section 2a or at the housing
middle
section 2b. In the closed position of the device this touches one end of the
horizontal
arrester bolt 55 which is elastically housed against the spring 56. The other
end of the
arrester bolt lies on the pressure piston. The closure key 54 cannot be
operated in this
position. Only when the compression spring 16 is tensioned by rotation of the
housing
lower section 3 against the housing middle section 2b, the compression spring
housing
31 being entrained via the closure 64 by the housing lower section, the
pressure piston
6 guided back into the housing middle section, is the path for the arrester
bolt released
out from this position in the direction of the pressure piston. In this
position the closure
key 54 can be pressed and the housing upper section opened. In this version
the
pressure piston has a stepped constriction 57 and the freedom of movement of
the
CA 02497680 2005-03-03
arrester bolt 55 is blocked by the thicker region. In other versions the
pressure piston 6
can have a constant diameter and the arrester bolt 55 is released only when
the
pressure piston is held by the tensioned compression spring 16 underneath the
arrester
bolt.
Fig. 18a shows an accommodation chamber into which a container cartridge (10)
with a
baseplate (63) with a cross-section in the shape of a circle segment according
to Fig.
18b. is inserted. The container tapers top-side in steps. The thus-developed
shoulder is
held by a narrower section in the accommodation chamber.
Fig. 18c shows the same container with a triangular baseplate (63) and the
container
according to Fig. 18d has a square baseplate (63).
Fig. 18e shows a container (10) with a circle-segment-like cross-section but a
round
baseplate (63) according to Fig. 19f which is located in the accommodation
chamber
which is complementary thereto.
Figures 19a and 19b demonstrate a version which is designed such that a user
of the
present invention cannot injure himself if the container cartridge (10) is
inadvertently
introduced from above into an accommodation chamber (30) for which there is
provision
for the container cartridge to be fed only from below. Fig. 19a shows a
container
cartridge (10) which was introduced coming from below into the accommodation
chamber (30). The device is in tensioned state. Fig. 19b shows the case in
which the
container cartridge (10) is fed from above. The device is in relaxed state.
The container
cartridge (10) can be pushed into the accommodation chamber (30) only by the
head
region, because the shoulder then strikes the top edge of the tapering
accommodation
chamber (30). In the relaxed state of the apparatus according to the
invention, the
pressure piston (6) does not extend far enough into the accommodation chamber
(30)
to be able to touch the container cartridge (10).
CA 02497680 2005-03-03
36
List of reference numbers
1 Device for the exertion of pressure 25 Tongue-shaped recess of the
optionally with container housing
2 Unit comprising housing upper section 26 Housing
and housing middle section 27 Hinged arm
2a Housing upper section 28 Mechanical drive unit
2b Housing middle section with locking 29 Atomization facility
clamping means 30 Accommodation chamber
3 Housing lower section 31 Compression spring housing
4 Opening 32 Snap catch
Axis of symmetry 33 Drive flange
6 Pressure piston 34 Locking member
7 Protective cap 35 Release key cf. 46
8a Locking mechanism 36 Lower stop
8b Locking mechanism 37 Upper stop
9 Outlet for liquid 38 Guide cylinder
Container cartridge 39 Container piston
11 Groove 40 Stock cylinder
12 Holding means 41 Nozzle structure
13 Movable button 42 Base part
14 Transport carriage 43 Non-etched part of the base part
Clamping element / Drive flange 44 Nozzle opening
16 Compression spring 45 Filter-forming projections
17 Mouthpiece 46 Nozzle inlet side
18 Grip 47 Closure key cf. 54
19 Hinge cf. 48 48 Hinge cf. 19
Detent 49 Arrester bolt
21 Swivelling flap 50 Locking bolt
22 Release button 51 Spring
23 Movement mechanism 52 Recess
24 Tongue-shaped section of the protective 53 Thick region of the locking bolt
cap 54 Closure key cf. 47
55 Arrester bolt
CA 02497680 2005-03-03
37
56 Spring
57 Constriction
58 Upper sealing means
59 Lower sealing means
60 Holder
61 Crimping sleeve
62 Screw cap
63 Baseplate
64 Closure between housing lower section
and compression spring housing
