U.S. patent application number 11/064614 was filed with the patent office on 2005-08-25 for nebulizer.
This patent application is currently assigned to Boehringer Ingelheim International GmbH. Invention is credited to Kunze, Hubert, Wuttke, Gilbert.
Application Number | 20050183718 11/064614 |
Document ID | / |
Family ID | 34862946 |
Filed Date | 2005-08-25 |
United States Patent
Application |
20050183718 |
Kind Code |
A1 |
Wuttke, Gilbert ; et
al. |
August 25, 2005 |
Nebulizer
Abstract
A nebulizer for a fluid is proposed, particularly for medicinal
aerosol therapy. To allow easy operation, the nebulizer has a valve
device, so that air supply openings in a mouthpiece can be blocked
off.
Inventors: |
Wuttke, Gilbert; (Dortmund,
DE) ; Kunze, Hubert; (Dortmund, DE) |
Correspondence
Address: |
MICHAEL P. MORRIS
BOEHRINGER INGELHEIM CORPORATION
900 RIDGEBURY ROAD
P. O. BOX 368
RIDGEFIELD
CT
06877-0368
US
|
Assignee: |
Boehringer Ingelheim International
GmbH
Ingelheim
DE
|
Family ID: |
34862946 |
Appl. No.: |
11/064614 |
Filed: |
February 24, 2005 |
Current U.S.
Class: |
128/200.14 |
Current CPC
Class: |
A61M 15/0015 20140204;
A61M 2016/0021 20130101; B05B 7/0012 20130101; A61M 15/0018
20140204; A61M 15/0021 20140204; A61M 2016/0039 20130101; A61M
15/0065 20130101; A61M 15/0081 20140204; A61M 11/007 20140204; B05B
11/3091 20130101 |
Class at
Publication: |
128/200.14 |
International
Class: |
A61M 011/00 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 24, 2004 |
DE |
202004002610 |
Jul 29, 2004 |
DE |
102004036925 |
Claims
We claim:
1. A nebulizer for a fluid comprising: a mouthpiece and at least
one air supply opening associated with the mouthpiece, the fluid
being sprayable into the mouthpiece, wherein the air supply opening
is associated with at least one valve device by means of which a
backflow through the air supply opening or openings can be
blocked.
2. The neubulizer according to claim 1, characterised in that the
valve device is arranged in the mouthpiece or laterally alongside
an expulsion nozzle for the fluid.
3. The neubulizer according to claim 1, characterised in that the
valve device can preferably be inserted as construction unit in the
mouthpiece.
4. The neubulizer according to claim 1, characterised in that least
one component of the valve device is fixedly mounted on the
nebulizer.
5. The neubulizer according to claim 1, characterised in that the
valve device can preferably be changed together with the
mouthpiece.
6. The neubulizer according to claim 1, characterised in that the
valve device operates at least substantially independently of the
spatial orientation of the nebulizer.
7. The neubulizer according to claim 1, characterised in that the
valve device comprises at least one valve and/or a moveable valve
element.
8. The neubulizer according to claim 7, characterised in that the
valve element is moveable in the longitudinal direction of the
nebulizer and/or in the direction of an air supply current through
the air supply opening or openings.
9. The neubulizer according to claim 7, characterised in that
several or all of the air supply openings are associated with a
common valve and/or a common valve element.
10. The neubulizer according to claim 7, characterised in that a
separate valve 29 and/or a separate valve element is or are
associated with each air supply opening.
11. The neubulizer according to claim 7, characterised in that the
valve element is in the form of a plate or flap.
12. The neubulizer according to claim 7, characterised in that the
valve element is at least substantially rigid in construction.
13. The neubulizer according to claim 7, characterised in that the
valve element is of flexible construction in the manner of a
foil.
14. The neubulizer according to claim 7, characterised in that the
valve element is biased into the open or closed positiony by spring
force, inherent elasticity, or gravity.
15. The neubulizer according clam 1, characterised in that the
nebulizer comprises a sensor which is associated with the valve
device for detecting opening or closing of the valve device.
16. The neubulizer according to claim 16, characterised in that the
sensor detects movements or at least one position of the valve
element by mechanical, optical, electrical, inductive, capacitive,
or other contactless means.
17. The neubulizer according to claim 16, characterised in that the
sensor is constructed as a microswitch or reed contact.
18. The neubulizer according to claim 16, characterised in that the
nebulizer has a monitoring device which counts and/or evaluates
actuations of the nebulizer or detects whether the sensor has
detected opening and/or closing of the valve device or valve
element.
19. The neubulizer according to claim 1, characterised in that the
nebulizer comprises an opening which contains the fluid,
particularly a liquid, and is moveable preferably in a stroke
during the production of pressure or nebulization.
20. The neubulizer according to claim 1, characterised in that the
nebulizer is constructed so that the fluid can be nebulized
independently of an air supply current through the air supply
opening or air supply openings.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to a nebulizer according to
the preamble of claim 1.
[0003] 2. Description of the Prior Art
[0004] The starting point for the present invention is a nebulizer,
in the form of an inhaler as shown in principle in WO 91/14468 and
specifically in WO 97/12687 (FIGS. 6a, 6b) and in FIGS. 1 and 2 of
the enclosed drawings. The nebulizer comprises as a reservoir for a
fluid which is to be nebulized an insertable container with the
fluid and a pressure generator with a drive spring for conveying
and atomising the fluid. WO 91/14468 and WO 97/12687 are hereby
incorporated by reference in their entireties. Generally, the
disclosure therein preferably refers to a nebulizer having a spring
pressure of 5 to 60 MPa, preferably 10 to 50 MPa on the fluid, with
fluid volumes of 10 to 50 .mu.l, preferably 10 to 20 .mu.l, most
preferably about 15 .mu.l delivered per actuation. The fluid is
converted into an aerosol the droplets of which have an aerodynamic
diameter of up to 20 .mu.m, preferably 3 to 10 .mu.m. Moreover, the
disclosure therein preferably relates to a nebulizer with a
cylinder-like shape which is about 9 cm to about 15 cm long and
about 2 to about 5 cm wide and a nozzle spray spread of from
20.degree. to 160.degree., preferably from 80.degree. to
100.degree.. These magnitudes also apply to the nebulizer according
to the teaching of the invention as particularly preferred
values.
[0005] By rotating an actuating member in the form of a lower
housing part of the nebulizer the drive spring can be put under
tension and fluid can be drawn up into a pressure chamber of the
pressure generator. After manual actuation of a locking element the
fluid in the pressure chamber is put under pressure by the drive
spring and expelled through a nozzle into a mouthpiece to form an
aerosol, without the use of propellant gas or the like. The speed
of the aerosol cloud is very low, with the result that the cloud of
aerosol is virtually stationary in the mouthpiece. A user then has
to inhale the resulting aerosol slowly for as long as possible,
e.g. 10 seconds or more. The mouthpiece has at least one air supply
opening through which the user, on inhaling, sucks in air from the
atmosphere together with the aerosol produced. This ensures that
the air stream of supplied air and aerosol necessary for inhalation
is produced and that the volume of aerosol needed for the
inhalation process is available.
[0006] The problem of the present invention is to provide a
nebulizer with improved safety of operation, so that it is ensured
that the aerosol can be breathed in or inhaled safely even when a
user has problems coordinating the operation of the nebulizer with
their breathing in.
SUMMARY OF THE INVENTION
[0007] This problem is solved by a nebulizer according to claim 1.
Advantageous features are recited in the subsidiary claims.
[0008] A basic idea of the present invention resides in the fact
that the nebulizer comprises a valve device which is associated
with the air supply opening or openings, so that backflow--i.e.
blow-out--through the air supply opening or openings can be
prevented. Thus an inexpensive and effective method is provided to
ensure that breathing out by the user does not result in an
unwanted expulsion of the nebulized fluid or aerosol from the
mouthpiece through the air supply opening or openings into the
environment.
[0009] The valve device provided preferably ensures that in the
event of the user (unintentionally) breathing out into the
mouthpiece an overpressure is produced which indicates a
malfunction to the user, to inform him that in future he should
only breathe out when using the nebulizer.
[0010] Moreover, after the user has accidentally breathed out
prematurely, inhalation can be continued, as the nebulized fluid or
aerosol still present in the mouthpiece can continue to be breathed
in.
[0011] The solution described is applicable not only to the
nebulizer or inhaler described above, but also to any kind of
inhaler in which an aerosol produced has to be supplied with air
from the atmosphere through a mouthpiece having air supply openings
to achieve the inhalation volume needed for the user. In addition,
it is also possible in particular to use nebulizers in which
propellant-free aqueous or alcoholic solutions containing active
substances are nebulized. However, the invention may also be used
in conventional propellant-driven nebulizers or inhalers,
particularly so-called MDIs (metered dose inhalers) and other
nebulizers.
[0012] According to a particularly preferred feature the valve
device has an associated sensor for detecting opening or closing or
movement of a valve element of the valve device. Thus, correct use
of the nebulizer, e.g. sufficiently long and/or powerful
inhalation, can be detected. The nebulizer preferably comprises a
suitable monitoring device or the like.
DESCRIPTION OF THE FIGURES
[0013] Further advantages, features, properties and aspects of the
present invention will become apparent from the following
description of preferred embodiments referring to the drawings,
wherein:
[0014] FIG. 1 is a diagrammatic section through a known nebulizer
in the untensioned state;
[0015] FIG. 2 shows a diagrammatic section through the known
nebulizer in the tensioned state, rotated through 90.degree.
compared with FIG. 1;
[0016] FIG. 3 is a diagrammatic sectional view of a detail of a
mouthpiece of a proposed nebulizer according to a first embodiment
with a valve device in the closed state;
[0017] FIG. 4 is a detail from FIG. 3 along the dotted line, shown
on a larger scale;
[0018] FIG. 5 is a diagrammatic representation of the valve device
according to FIG. 3 in the open state;
[0019] FIG. 6 is a detail from FIG. 5 along the dotted line, shown
on a larger scale;
[0020] FIG. 7 is a diagrammatic sectional view of a detail of a
mouthpiece of a proposed nebulizer according to a second embodiment
with a valve device in the closed state;
[0021] FIG. 8 is a sectional view of the valve device according to
FIG. 7 in the open state;
[0022] FIG. 9 is a diagrammatic sectional view of a detail of a
mouthpiece of a proposed nebulizer according to a third embodiment
with a valve device in the closed state;
[0023] FIG. 10 is a sectional view of the valve device according to
FIG. 9 in the open state;
[0024] FIG. 11 is a sectional view corresponding to FIG. 9 of a
valve device according to a fourth embodiment in the closed
state;
[0025] FIG. 12 is a sectional view of the valve device according to
FIG. 11 in the open state;
[0026] FIG. 13 is a sectional view corresponding to FIG. 9 of a
valve device according to a fifth embodiment in the closed
state;
[0027] FIG. 14 is a detail from FIG. 13 along the dotted line,
shown on a larger scale;
[0028] FIG. 15 is a sectional view of the valve device according to
FIG. 13 in the open state;
[0029] FIG. 16 is a detail from FIG. 15 along the dotted line,
shown on a larger scale;
[0030] FIG. 17 is a diagrammatic sectional view of a detail of a
mouthpiece of a proposed nebulizer according to a sixth embodiment
with a valve device in the closed state;
[0031] FIG. 18 is a plan view of the nebulizer according to FIG.
17;
[0032] FIG. 19 is a sectional view of the valve device according to
FIG. 17 in the open state;
[0033] FIG. 20 is a plan view of the nebulizer according to FIG.
19;
[0034] FIG. 21 is a piece of material for forming valve elements of
the valve device according to the sixth embodiment;
[0035] FIG. 22 is a diagrammatic sectional view of a proposed
nebulizer according to a seventh embodiment with a valve device in
the open state and with an associated sensor;
[0036] FIG. 23 is a diagrammatic sectional view of a detail of a
mouthpiece of a proposed nebulizer according to an eighth
embodiment with a valve device in the closed state;
[0037] FIG. 24 is a sectional view according to FIG. 23 with the
valve device open; and
[0038] FIG. 25 is a plan view of the valve element of the valve
device according to FIG. 23.
[0039] In the Figures, identical reference numerals are used for
identical or similar parts, and corresponding or comparable
properties and advantages are achieved even if the description is
not repeated.
DESCRIPTION OF THE INVENTION
[0040] FIGS. 1 and 2 show a known nebulizer 1 for nebulizing a
fluid 2, particularly a highly effective pharmaceutical composition
or the like, viewed diagrammatically in the untensioned state (FIG.
1) and in the tensioned state (FIG. 2). The nebulizer is
constructed in particular as a portable inhaler and preferably
operates without propellant gas.
[0041] When the fluid 2, preferably a liquid, more particularly a
pharmaceutical composition, is nebulized, an aerosol is formed
which can be breathed in or inhaled by a user. Usually the inhaling
is done at least once a day, more particularly several times a day,
preferably at set intervals.
[0042] The nebulizer 1 has an insertable and preferably
exchangeable container 3 containing the fluid 2, which forms a
reservoir for the fluid 2 which is to be nebulized. Preferably, the
container 3 contains an amount of fluid 2 which contains sufficient
amounts of active substance formulations to provide, for example,
up to 100 dosage units. A typical container 3, as disclosed in WO
96/06011, holds a volume of about 2 to 10 ml.
[0043] The container 3 is substantially cylindrical or
cartridge-shaped and once the nebulizer 1 has been opened the
container can be inserted therein from below and changed if
desired. It is preferably of rigid construction, the fluid 2 in
particular being held in a collapsible bag 4 in the container
3.
[0044] The nebulizer 1 has a pressure generator 5 for conveying and
nebulizing the fluid 2, particularly in a preset and optionally
adjustable dosage amount. The pressure generator 5 has a holder 6
for the container 3, an associated drive spring 7, shown only in
part, with a locking element 8 which can be manually operated to
release it, a conveying tube 9 with a non-return valve 10, a
pressure chamber 11 and an expulsion nozzle 12 in the region of a
mouthpiece 13. The container 3 is fixed in the nebulizer 1 by means
of the holder 6 such that the conveying tube 9 is immersed in the
container 3. The holder 6 may be constructed so that the container
3 can be changed.
[0045] As the drive spring 7 is axially tensioned the holder 6 with
the container 3 and the conveying tube 9 is moved downwards in the
drawings and fluid 2 is sucked out of the container 3 into the
pressure chamber 11 of the pressure generator 5 through the
non-return valve 10. As the expulsion nozzle 12 has a very small
cross section of flow and is constructed in particular as a
capillary, such a strong throttle action is produced that the
intake of air by suction is reliably prevented at this point even
without a non-return valve.
[0046] During the subsequent relaxation after actuation of the
locking element 8 the fluid 2 in the pressure chamber 11 is put
under pressure as the conveying tube 9 with its non-return valve 10
now closed is moved back upwards by the relaxation of the drive
spring 7 and now acts as a pressure ram. This pressure forces the
fluid 2 through the expulsion nozzle 12, where it is nebulized into
an aerosol 14.
[0047] A user can inhale the aerosol 14, while an air supply can be
sucked into the mouthpiece 13 through at least one air supply
opening 15.
[0048] The nebulizer 1 comprises an upper housing part 16 and an
inner part 17 which is rotatable relative thereto, having an upper
part 17a and a lower part 17b, while a housing part 18 which is, in
particular, manually operable, is releasably fixed, particularly
fitted, onto the inner part 17, preferably by means of a retaining
element 19. In order to insert and/or replace the container 3 the
housing part 18 can be detached from the nebulizer 1.
[0049] The housing part 18 can be rotated counter to the housing
part 16, taking with it the part 1 7b of the inner part 17 which is
the lower part in the drawings. In this way the drive spring 7 is
tensioned in the axial direction by means of a gear acting on the
holder 6. During tensioning the container 3 is moved axially
downwards until the container 3 assumes an end position as shown in
FIG. 2. In this position the drive spring 7 is under tension.
During the nebulizing process the container 3 is moved back into
its original position by the drive spring 7. The container 3 thus
performs a stroke during the tensioning process and during
nebulization.
[0050] The housing part 18 preferably forms a cap-like lower
housing part and fits around or over a lower free end portion of
the container 3. As the drive spring 7 is tensioned the container 3
moves with its end portion (further) into the housing part 18 or
towards the end face thereof, while an axially acting spring 20
arranged in the housing part 18 comes to bear on the base 21 of the
container and pierces the container 3 or a seal on its base with a
piercing element 22 when the container makes contact with it for
the first time, to allow air in.
[0051] The nebulizer 1 comprises a monitoring device 23 which
counts the actuations of the nebulizer 1, preferably by detecting
any rotation of the inner part 17 relative to the upper housing
part 16.
[0052] The construction and mode of operation of a proposed
nebulizer 1 will now be described in more detail, referring to
FIGS. 3 to 22, but emphasising only the essential differences from
the nebulizer 1 according to FIGS. 1 and 2. The remarks relating to
FIGS. 1 and 2 thus apply accordingly.
[0053] FIGS. 3 to 6 show, in sectional diagrammatic representations
of details, a proposed nebulizer 1 having a valve device 24
according to a first embodiment. FIG. 3 shows the valve device 24
in the closed state. FIG. 4 shows a detail from FIG. 3 along the
dotted line. FIG. 5 shows the valve device 24 in the open state.
FIG. 6 shows a detail from FIG. 5 along the dotted line.
[0054] In the open state the valve device 24 allows an air supply
current 25, as indicated by corresponding arrow in FIGS. 5 and 6,
through the air supply openings 15 into the mouthpiece 13 during
inhalation, i.e. breathing in, by a user of the nebulizer 1. The
user puts the mouthpiece 13 in his mouth and should breathe as
evenly and slowly as possible, preferably for several seconds,
particularly about 10 seconds or more, thereby inhaling the
nebulized fluid 2 or aerosol 14. The air supply is thus breathed in
at the same time but is not used to nebulize the fluid 2 or produce
the aerosol 14. Rather, this is done separately or independently,
preferably without the use of propellant gas, by the pressure
generator 5 as explained hereinbefore.
[0055] In the embodiment shown the valve device 24 is arranged in
the mouthpiece 13 and preferably alongside the expulsion nozzle 12
for the fluid 2 or aerosol 14. Alternatively, the valve device 24
may be mounted on the outside of the mouthpiece 13 or be associated
therewith in some other way. An external arrangement has the
advantage that the valve device 24 is not exposed directly to the
aerosol cloud in the mouthpiece 13, thereby preventing soiling of
the valve device 24.
[0056] Preferably, the valve device 24 is inserted into the
mouthpiece 13 as a construction unit or assembly, in particular. It
can preferably be incorporated afterwards, i.e. as an add-on.
[0057] Alternatively, at least one part of the valve device 24 is
fixedly mounted, particularly formed, injection moulded, glued or
similar, to the nebulizer 1, particularly the mouthpiece 13.
[0058] According to an alternative embodiment, the valve device 24
can be replaced together with the mouthpiece 13. In the embodiment
shown, however, the mouthpiece 13 is preferably integrally
constructed with the nebulizer 1, especially the upper housing part
16 thereof, or is formed thereby.
[0059] The valve device 24 is constructed and associated with the
air supply openings 15 such that backflow through the air supply
openings 15--i.e. an airflow from the mouthpiece 13 through the air
supply openings 15 into the atmosphere (counter to the air supply
flow 15), which might be produced by the user breathing out, in
particular, can be prevented, especially automatically. This
ensures that the user breathing out cannot cause the nebulized
fluid 2 or aerosol 14 to be undesirably expelled through the air
supply openings 15 into the atmosphere. Rather, the valve device 24
preferably ensures that when the mouthpiece 13 is fitted it is only
possible to breathe in through the mouth of the user or through the
mouthpiece 13, so that there is a greater probability or certainty
of the nebulized fluid 2 or aerosol 14 being inhaled by the user.
This results in substantially better operational safety.
[0060] The valve device 24 is preferably constructed so as to
operate at least substantially independently of the spatial
orientation of the nebulizer 1.
[0061] The valve device 24 may if necessary operate by electrical,
magnetic, pneumatic or other means. The valve device 24 preferably
operates exclusively mechanically, as explained hereinafter with
reference to the preferred embodiments.
[0062] In the first embodiment the valve device 24 has a preferably
plate-shaped seat element 26 with through-openings 27 and a
moveable valve element 28 which is preferably also plate-shaped.
The seat element 26 is preferably of one-piece construction and is
inserted or incorporated in the mouthpiece 13 such that it seals
off the connection to the air supply openings 15 in such a way that
air can only flow into the mouthpiece 13 through the
through-openings 27.
[0063] The moveable valve element 28 is associated with the seat
element 26 or through-openings 27 so as to seal off the
through-openings 27 in the closed position shown in FIGS. 3 and 4
in order to prevent backflow as described above.
[0064] The seat element 26 and the valve element 28 thus together
form at least one valve 29, particularly a non return valve or one
way valve. However, the valve 29 may also be constructed in some
other suitable manner.
[0065] In the first embodiment, a common seat element 26 and a
common valve element 28 are provided for several and more
particularly all of the air supply openings 15. However, separate
seat elements 26, separate valve elements 28 or valves 29 operating
independently may be associated with the air supply openings 15, as
will be explained with reference to other embodiments.
[0066] In the first embodiment the valve element 28 is moveable in
the longitudinal direction of the nebulizer 1 and/or at least
substantially in the direction of the air supply current 25.
[0067] In the first embodiment the valve element 28 is biased into
the closed position, particularly by spring force, and in the
embodiment shown by springs 30, preferably helical springs.
However, it is also possible to use other suitable springs or
biasing means instead of these.
[0068] Alternatively or in addition, the valve element 28 may also
be biased into the closed position by its own elasticity and/or by
gravity.
[0069] Moreover, if necessary, the valve element 28 may also be
biased into the open position and/or may have two stable positions,
on the one hand the closed position and on the other hand the open
position, in particular.
[0070] In the first embodiment the valve element 28 preferably has
bar-like guide elements 31, which are particularly integrally
formed thereon, which serve both for moveable guidance and holding
of the valve element 28 on the nebulizer 1, particularly on the
seat element 26, and also serve to guide or hold the associated
springs 30.
[0071] The valve device 24 is preferably constructed so that the
valve device 24 opens as easily as possible to allow substantially
unobstructed inhalation or inspiration. The air supply current 25
is thus as unobstructed as possible. Accordingly, the valve element
28 is preferably easy-acting and the spring force acting in the
direction of closing in the first embodiment is as low as
possible.
[0072] Once the valve device 24 is open--i.e. with the valve
element 28 raised as shown in FIGS. 5 and 6--the air supply current
25 can flow at least largely unobstructed through the air supply
openings 15 and then through the through-openings 27 into the
mouthpiece 13 as the user breathes in or inhales.
[0073] Some additional embodiments of the proposed nebulizer or the
proposed valve device 24 will now be described with reference to
the other drawings. In particular, only essential differences from
the first embodiment will be described. Otherwise, the same
characteristics and benefits apply as in the first embodiment and
in the known nebulizer 1.
[0074] FIGS. 7 and 8 show a second embodiment of the proposed
nebulizer 1 and the proposed valve device 24. In FIG. 7 the valve
device 24 is closed. In FIG. 8 the valve device 24 is open.
[0075] In the second embodiment separate valve elements 28 or
valves 29 are associated with the air supply openings 15. The valve
elements 28 are constructed as flaps or tongues and are preferably
pivotable. The valve elements 28 preferably cooperate with separate
seat elements 26 or directly with the suitably shaped inner wall of
the mouthpiece 13, to form the valves 29.
[0076] In the second embodiment the valve elements 28 may if
desired be biased into the open position. This allows the user to
breathe in or inhale without obstruction. If, however, the user
breathes out into the mouthpiece 13, the valve elements 28 are at
least substantially instantly closed by the backflow produced,
thereby blocking off the backflow. The spring force acting in the
open position is selected to be correspondingly low.
[0077] Alternatively, however, in the second embodiment, the valve
elements 28 may be biased into the closed position as in the first
embodiment.
[0078] FIGS. 9 and 10 show a third embodiment of the proposed
nebulizer 1 or the proposed valve device 24. FIG. 9 shows the valve
device 24 in the closed state. FIG. 10 shows the valve device 24 in
the open state.
[0079] In the third embodiment, preferably several separate or
independently operating valve elements 28 or valves 29 are again
provided, and in particular associated with the air supply openings
15.
[0080] As in the second embodiment the valve elements 28 are also
constructed as plates or tappets. Preferably, the valve elements 28
are guided in a common seat element 26 as in the first
embodiment.
[0081] Again, the valve elements 28 and valves 29 are preferably
biased into the closed position by springs 30, particularly helical
springs.
[0082] In the third embodiment each valve element 28 preferably
comprises a guide element 31 which in turn, as in the first
embodiment, serves on the one hand to guide and hold the valve
element 28 preferably on the seat element 26 and on the other hand
to guide or hold the associated spring 30.
[0083] FIGS. 11 and 12 show a fourth embodiment of the proposed
nebulizer 1 or the proposed valve device 24. FIG. 11 shows the
valve device 24 in the closed state. FIG. 12 shows the valve device
24 in the open state.
[0084] The fifth embodiment substantially corresponds to the fourth
embodiment. Only the springs 30 have been omitted. The valve
elements 28 are thus freely moveable or easily moveable, and in
particular are not biased by spring force. However, in the
arrangement shown and on the basis that the nebulizer 1 is aligned
at least substantially vertically during use, the valve elements 28
may adopt a preferred position, namely the closed position, as a
result of gravity.
[0085] FIGS. 13 to 16 show a fifth embodiment of the proposed
nebulizer 1 or of the proposed valve device 24. FIG. 13 shows the
valve device 24 in the closed state. FIG. 14 shows a detail from
FIG. 13 along the dotted line. FIG. 15 shows the valve device 24 in
the open state. FIG. 16 shows a detail from FIG. 15 along the
dotted line.
[0086] The fifth embodiment substantially corresponds to the third
embodiment except that the spring arrangement has essentially been
altered. The springs 30 are preferably formed as helical springs,
particularly as compression springs. However, in the fifth
embodiment, the springs 30 are arranged on the side of the seat
element 26 remote from the air supply openings 15, the plates 32 of
the valve elements 28 having a suitable recess 33, which is annular
in the embodiment shown, for receiving the associated spring
30.
[0087] In the fifth embodiment the valve elements 28 and valves 29
are thus preferably biased into the open position. Regarding the
arrangement and setting of the spring force the same remarks apply
as in respect of the second embodiment.
[0088] FIGS. 17 to 21 show a sixth embodiment of the proposed
nebulizer 1 or proposed valve device 24. FIGS. 17 and 18 show the
valve device 24 in the closed state. FIGS. 19 and 20 show the valve
device 24 in the open state. FIG. 21 shows a development or a piece
of material 34 which forms the valve elements 28 of the valve
device 24 according to the sixth embodiment.
[0089] The valve elements 28 are elastic and flexible in
construction. Because of their inherent elasticity the preferably
tongue- or flap-shaped valve elements 28 in the sixth embodiment
assume the closed position as their preferred position, i.e. they
close off the air supply openings 15.
[0090] During inhaling or breathing in, the valve elements 28 are
moved or pivoted inwards, as shown in FIG. 19 in particular. Thus,
the air supply openings 15 are opened up and air can flow into the
mouthpiece 13.
[0091] The valve elements 28 are preferably formed from the same
piece of material 34, particularly a foil or other suitable
materials. However, the valve elements 28 may also be formed from
separate pieces of material 34.
[0092] The plan view in FIG. 18 illustrates the closed state. The
valve elements 28 are lying flat, i.e. they are not visible in plan
view.
[0093] In the plan view shown in FIG. 20 the valve elements 28 are
shown in the open state and are accordingly flipped or pivoted
inwards.
[0094] The plan views in FIGS. 18 and 20 show that the valve device
24 or the piece of material 34 can be inserted in the inside of the
mouthpiece in an encircling or at least substantially flat
position. This allows easy and hence inexpensive assembly and in
particular allows modification of the nebulizer 1.
[0095] According to another alternative embodiment, the valve
device 24 or the valve 29 may be constructed so that the valve
element 28 is moveable exclusively by gravity and/or the air supply
current 25 or an opposite airflow and as a result the associated
air supply openings 15 can be opened up or closed off. For example,
the valve element 28 may be constructed for this purpose as a loose
sealing element or as a loose washer or gasket which is
correspondingly moveably mounted in an air supply channel or the
like adjacent to the air supply opening 15 or in the mouthpiece 13.
In this way it is possible for example to ensure by means of
suitable grids, holders, guides, shoulders, constrictions or the
like, that the valve element 28 cannot be moved away from its
associates air supply opening 15 at will when the air supply
current 25 is breathed in, so that as the user breathes out into
the mouthpiece 13 an initial backflow immediately causes the valve
element 28 to close the associated air supply opening 15 and
thereby block the undesirable backflow.
[0096] The embodiments described hereinbefore show various
constructional solutions. However, other suitable constructional
solutions are possible, and if necessary different valve means 24
may be used instead of valve devices 24 which operate purely
mechanically.
[0097] An essential aspect of the present invention is the fact
that the nebulizing of the fluid 2 or the production of the aerosol
14 takes place independently of the air supply current 25. Instead
of the direct expulsion of the aerosol 14 through the expulsion
nozzle 12 into the mouthpiece 13 the aerosol 14 may initially be
expelled into some other receiving chamber in the nebulizer 1 and
then be transported to the actual mouthpiece 13 during inhalation
or breathing in by the air supply current 25 and be inhaled through
it. Accordingly, the term "mouthpiece" is to be understood more
broadly as preferably meaning that it comprises a receiving or
collecting chamber for the aerosol 14 produced, to which an air
supply can be fed through air supply openings 15 and to which a
preferably tubular section is attached which is then actually
placed in the user's mouth for inhaling or breathing in.
[0098] A preferred feature will now be described in more detail
with reference to a seventh embodiment of the proposed nebulizer 1,
referring to the diagrammatic sectional view in FIG. 22. This
additional feature may if necessary be combined, in particular,
with the embodiments or valve devices 24 described
hereinbefore.
[0099] The nebulizer 1 comprises a sensor 35 which is associated
with the valve device 24, particularly the moveable valve element
28 or at least one valve 29. The sensor 35 serves to detect the
open position, the closed position and/or a movement of the valve
device 24, particularly the valve element 28.
[0100] The sensor 35 thus also serves to detect movements or at
least a position of the valve element 28, and this is done by
mechanical, optical, electrical, inductive, capacitive and/or other
contactless means. In particular, the sensor 35 is in the form of a
microswitch or reed contact.
[0101] In the embodiment shown the sensor 35 is arranged in the
immediate vicinity of or adjacent to the valve element 28 and/or in
the mouthpiece 13.
[0102] By means of the sensor 35 the air supply current 25 is
preferably detected indirectly by the opening of the valve device
24, at least the opening of at least one valve element 28 or valve
29. Thus, the actual inhalation of the aerosol 14 produced by the
nebulizer 1 can be detected.
[0103] Additionally, or alternatively a so called flow sensor may
be provided for directly detecting an airflow and may be arranged
in particular adjacent to the air supply openings 15.
[0104] In the seventh embodiment the monitoring device 23 is
preferably arranged in the housing part 18 and/or constructed so as
to be able to detect and evaluate signals from the sensor 35. For
this purpose the monitoring device 23 is preferably operated
electrically, the sensor 35 preferably being connected to the
monitoring device 23 by electrical or wireless means.
[0105] The detection by means of the sensor 35 of actual inhalation
of the fluid 2 or aerosol 14 can be evaluated by the monitoring
device 23 to see whether the inhalation has been sufficiently long,
and the inhalation time can if necessary be stored and/or
displayed. Moreover, this actual inhalation, particularly combined
with actual nebulization or a stroke of the container 3 can be
detected or counted, displayed and/or stored as the actuation or
use of the nebulizer 1.
[0106] The monitoring device 23 may, however, also be provided
independently of the sensor 35 and may, if necessary, operate
mechanically or electrically or electronically, for example.
[0107] The proposed nebulizer 1 is preferably constructed to use a
liquid as the fluid 2 which is nebulized.
[0108] The embodiments described hereinbefore, particularly
individual elements and aspects of the embodiments, may if
necessary be combined with one another and/or kinematically
reversed.
[0109] The present invention relates generally speaking to
nebulizers 1 for inhalation which generate a virtually stationary
cloud of aerosol or a cloud of aerosol with such a low exit speed
that the propagation of the cloud of aerosol virtually comes to a
stand still after a few centimetres. The exit speed or at least the
initial speed of propagation of the cloud of aerosol is preferably
about 5 to 20 m/min, particularly 10 to 15 m/min and most
preferably about 12.5 m/min.
[0110] In particular because of the low exit speed or speed of
propagation the air supply current 25 is needed for taking in the
aerosol 14 by inhalation. However, a slight air supply current 25
is preferably sufficient for taking in the aerosol 14 by
inhalation.
[0111] In order to enable or ensure the desired operation of the
nebulizer 1 even at low flow speed and/or flow volumes, the valve
device 24 or the valve element 28 thereof or the valve 29 is
relatively easy-acting and can be closed with particularly little
force. The closing force is preferably only a few cN or less. In
particular, the closing force is less than 1 cN, most preferably
less than 0.5 cN. The closing force may be produced by gravity
alone, inherent elasticity and/or spring bias, particularly from
the spring 30, especially in the flap-like construction. In
particular, the spring force is preferably only a few cN,
particularly not more than 1 cN and most preferably at most 0.5 cN
or less.
[0112] FIGS. 23 and 24 additionally shown an eighth embodiment of
the proposed nebulizer 1 or the proposed valve device 24. FIG. 23
shows the valve device 24 in the closed state. FIG. 24 shows the
valve device 24 in the open state. FIG. 25 is a plan view of the
valve element 28 which is plate shaped in this case.
[0113] The valve element 28 here is particularly of rigid
construction. In the eighth embodiment it comprises a central
recess or opening which is designed so that the central projection
with the expulsion nozzle 12 can pass through it, at least when the
valve device 24 is closed, as shown in FIG. 23. Thus, the inner
contour is designed with the necessary play to fit the projection
comprising the expulsion nozzle 12 or other parts of the nebulizer
1 inside the mouthpiece 13.
[0114] The outer contour of the valve element 28 is matched to the
inner contour of the mouthpiece 13 and in the embodiment shown is
elliptical in shape.
[0115] Inside the mouthpiece 13, a inner O-ring 36 and an outer
O-ring 37, which are arranged concentrically around or below the
expulsion nozzle 12 in the embodiment shown form, in particular, a
sealing valve seat for the valve element 28 when the valve device
24 is closed. In particular, as a result of its own weight, the
valve element 28 bears on the O-rings 36, 37 or other suitable
seals to prevent undesirable backflow through the air supply
openings 15 (in the closed state).
[0116] During inhaling, the valve element 28 is raised by the under
pressure, as shown in FIG. 24, as a result of which the valve
device 24 or the valve 29 formed by the valve element 28 is opened.
The air supply current 25 can then flow into the mouthpiece 13,
particularly between the central projection in the embodiment
shown, which contains the expulsion nozzle 12, and the central
recess of the valve element 28.
[0117] In the embodiment shown the O-rings 36, 37 are held on
suitable annular shoulders, steps or the like in the nebulizer 1 or
mouthpiece 13. However, other constructional solutions are also
possible, particularly when other suitable seals are used.
[0118] In order to limit the play or the stroke of the valve
element 28, the nebulizer 1 in the eighth embodiment preferably
comprises an insert 38 or the like inside the mouthpiece 13, as
shown in FIGS. 23 and 24. This insert 38 may if necessary be of a
circumferential construction and is adapted in particular to the
preferably elliptical inner contour of the mouthpiece 13. If
necessary the insert 38 is injection moulded, e.g. in the so called
2C process, i.e. in a 2-component injection process. However, other
constructional solutions are also possible.
[0119] The radial play of the valve element 28 inside the
mouthpiece 13 and the mass of the valve element 28 are adapted so
that the valve device 24 or valve 29 has the desired easy action.
In particular, the remarks made above apply with regard to the
closing or opening force.
* * * * *